issue-1996-03-08•Federal Register proposed rules — 1996-03-08
Federal Register proposed rules — 1996-03-08
issue-1996-03-08Federal Register proposed rules — 1996-03-08Proposed Regulation
Published Federal Register documents, not public-inspection drafts. The GPO XML/text rendition is a research aid; the linked complete official PDF retains the printed layout and all graphics. Graphics are retained in that PDF and are not independently reproduced in this text rendition. Publication does not establish that every provision remains legally in force.
FR Doc. 96-5580 Animal Welfare; Marine Mammals
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Page 9371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5580]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 61, No. 47 / Friday, March 8, 1996 / Proposed
Rules
[[Page 9371]]
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Parts 1 and 3
[Docket No. 93-076-8]
RIN 0579-AA59
Animal Welfare; Marine Mammals
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of meeting.
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SUMMARY: The purpose of this notice is to announce the second and final
meeting of the Marine Mammal Negotiated Rulemaking Advisory Committee.
DATES: April 1 through 3, 1996, from 8:30 a.m. to 4:30 p.m. each day.
ADDRESSES: The meeting will be held at the USDA Center at Riverside,
Conference Center Rooms A and B, 4700 River Road, Riverdale, Maryland
20737, (301) 734-7833.
FOR FURTHER INFORMATION CONTACT: Dr. Barbara Kohn, Senior Staff
Veterinarian, Animal Care Staff, REAC, APHIS, 4700 River Road Unit 84,
Riverdale, MD 20737-1234, (301) 734-7833.
SUPPLEMENTARY INFORMATION: In a Federal Register notice published on
May 22, 1995 (60 FR 27049-27051, Docket No. 93-076-3), we announced our
intent to establish a Marine Mammal Negotiated Rulemaking Advisory
Committee (Committee), chartered under the Federal Advisory Committee
Act (Pub. L. 92-463). The Committee will review the current regulations
and standards under the Animal Welfare Act concerning the care and
maintenance of captive marine mammals, and provide consensus language
to amend the regulations. The first meeting of the Committee, which was
announced in a Federal Register notice published on September 8, 1995
(60 FR 46783-46784, Docket No. 93-076-7), was held on September 25-26,
1995. This notice announces the second and final meeting of the
Committee.
The purpose of the meeting is to bring together members of the
Animal and Plant Health Inspection Service, representatives of the
marine mammal public display community, the marine mammal research
community, the animal welfare community, and members of other Federal
agencies with a definable stake in marine mammal care issues to frame a
recommended rulemaking proposal to amend the current regulatory program
concerning care and maintenance standards for captive marine mammals.
The Committee will determine the final agenda for the meeting at
its beginning. The tentative agenda for the meeting is as follows:
First Day
Morning Session--8:30 a.m.
Establish Agenda for Meeting
Discussion of Marine Mammal Regulations
Afternoon Session--1 p.m.
Discussion of Marine Mammal Regulations
Public Comments
Second Day
Morning Session--8:30 a.m.
Establish Agenda for Day
Committee Administrative Issues
Discussion of Marine Mammal Regulations
Afternoon Session--1 p.m.
Discussion of Marine Mammal Regulations
Public Comments
Third Day
Morning Session--8:30 a.m.
Establish Agenda for Day
Committee Administrative Issues
Discussion of Marine Mammal Regulations
Afternoon Session--1 p.m.
Discussion of Marine Mammal Regulations
Public Comments
The meeting will be open to the public. Public participation at the
meeting will be allowed during periods announced at the meeting for
this purpose.
This notice is given pursuant to section 10 of the Federal Advisory
Committee Act.
Done in Washington, DC, this 4th day of March 1996.
Lonnie J. King,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 96-5580 Filed 3-7-96; 8:45 am]
BILLING CODE 3410-34-P
Complete official Federal Register PDF
FR Doc. 96-5538 Lactofen; Pesticide Tolerance
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9399-9401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5538]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[PP 4E4418/P643; FRL-5353-2]
RIN 2070-AB18
Lactofen; Pesticide Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
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SUMMARY: EPA proposes to establish a tolerance for the combined
residues of the herbicide lactofen in or on the raw agricultural
commodity snap beans at 0.05 part per million (ppm). The proposed
regulation to establish a maximum permissible level for residues of the
herbicide was requested in a petition submitted by the Interregional
Research Project No. 4 (IR-4).
DATES: Comments, identified by the document control number [PP 4E4418/
P643], must be received on or before April 8, 1996.
ADDRESSES: By mail, submit written comments to: Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs, Environmental Protection Agency, 401 M St., SW.,
Washington, DC 20460. In person, bring comments to: Rm. 1132, CM #2,
1921 Jefferson Davis Highway, Arlington, VA 22202. Information
submitted as a comment concerning this document may be claimed
confidential by marking any part or all of that information as
``Confidential Business Information''. CBI should not be submitted
through e- mail. Information marked as CBI will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
comment that does not contain CBI must be submitted for inclusion in
the public record. Information not marked confidential may be disclosed
publicly by EPA without prior notice. All written comments will be
available for public inspection in Rm. 1132 at the address given above,
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.
Comments and data may also be submitted electronically by sending
electronic mail (e-mail) to: [email protected]. Electronic
comments must be submitted as an ASCII file avoiding the use of special
characters and any form of encryption. Comments and data will also be
accepted on disks in WordPerfect 5.1 file format or ASCII file format.
All comments and data in electronic form must be identified by the
docket number [PP 4E4418/P643]. No CBI should be submitted through e-
mail. Electronic comments on this proposed rule may be filed online at
many Federal Depository Libraries. Additional information on electronic
submissions can be found in SUPPLEMENTARY INFORMATION of this document.
FOR FURTHER INFORMATION CONTACT: By mail: Hoyt L. Jamerson,
Registration Division (7505W), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW., Washington,
[[Page 9400]]
DC 20460. Office location and telephone number: Sixth Floor, Crystal
Station #1, 2800 Jefferson Davis Highway, Arlington, VA 22202, (703)
308-8783, e-mail: [email protected].
SUPPLEMENTARY INFORMATION: The Interregional Research Project No. 4
(IR-4), New Jersey Agricultural Experiment Station, P.O. Box 231,
Rutgers University, New Brunswick, NJ 08903, has submitted pesticide
petition (PP) 4E4418 to EPA on behalf of the Agricultural Experiment
Stations of Arkansas, Florida, Georgia, Oregon, Tennessee, and
Virginia. This petition requests that the Administrator, pursuant to
section 408(e) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 346a(e), amend 40 CFR 180.432 by establishing a tolerance for
the combined residues of lactofen, 1-(carboethoxy)ethyl-5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2-nitrobenzoate, and its associated
metabolites containing the diphenyl ether linkage expressed as lactofen
in or on the raw agricultural commodity snap beans at 0.05 ppm. The
scientific data submitted in the petition and other relevant material
have been evaluated.
The toxicological data considered in support of the proposed
tolerance include:
(1) A 1-year feeding study with dogs fed diets containing 0, 40,
200, or 1,000/3,000 ppm with a no-observed-effect level (NOEL) of 200
ppm (equivalent to 5 milligrams (mg)/kilogram (kg)/day). Systemic
effects observed at the high dose level include decreased body weight,
renal dysfunction, a significant decrease in erythrocytes, hemoglobin,
and hematocrit, and a significant increase in blood platelets.
(2) A 2-year feeding/carcinogenicity study in rats fed diets
containing 0, 500, 1,000, or 2,000 ppm with a NOEL for systemic effects
of 500 ppm (equivalent to 25 mg/kg/day). Increased pigmentation of the
liver and kidney were observed in male and female rats at the 1,000 and
2,000 dose levels. There was an increased incidence of cellular
alterations and neoplastic nodules (benign) in the liver of rats
administered 2,000 ppm (100 mg/kg/day).
(3) An 18-month carcinogenicity study in mice fed diets containing
10, 50, or 250 ppm with statistically significant increases in liver
adenomas and carcinomas, and in the combined incidence of liver tumors
(adenomas and carcinomas) in high dose males. Statistically significant
increases in the incidences of liver adenomas and in combined liver
tumors (adenomas and carcinomas) were observed in high dose females.
Systemic effects include an increase in liver/body weight ratios and
enlarged liver cells in all treated males and the mid- and high-dose
females.
(4) A developmental toxicity study in rats given 0, 15, 50, or 150
mg/kg by oral gavage with no developmental toxicity observed under the
conditions of the study. Evidence of fetotoxicity (bent ribs) was
observed at the 150 mg/kg dose level.
(5) A developmental toxicity study in rabbits given 0, 1, 4, or 20
mg/kg/day by oral gavage with no evidence of developmental toxicity.
(6) A 2-generation reproduction study in rats fed diets containing
0, 50, 500, or 2,000 ppm with a NOEL at 50 ppm (equivalent to 2.5 mg/
kg/day) for reproductive and systemic effects. Reproductive effects
observed at the lowest-observed-effect level (500 ppm) include reduced
mean pup weight and increased pup heart and liver weights.
(7) Lactofen did not cause an increase in chromosomal aberrations
when tested with Chinese hamster ovary cells, was negative in a
mammalian cell forward mutation assay, and did not induce unscheduled
DNA synthesis in isolated rat hepatocytes. Lactofen did have a low
covalent binding index to mouse liver DNA in vivo and was positive in
the Ames Salmonella/microsome plate test using strain 1538.
Lactofen has been classified by the Office of Pesticide Program's,
Health Effects Division, Carcinogenicity Peer Review Committee (CPRC)
as a Group B2 carcinogen (probable human carcinogen). Lactofen met the
criteria of a B2 carcinogen in that it induced an increased incidence
of malignant tumors or combined malignant and benign tumors in mice and
rats. Although an increase in malignant tumors was not seen in rats,
the Committee felt that a B2 classification was appropriate since a
tumor response was seen in two species at the same site. In addition,
lactofen is structurally similar to acifluorfen, nitrofen, oxyfluorfen
and fomesafen, which have all been shown to produce liver tumors in
rodents.
Dietary risk assessments for lactofen indicate that there is
minimal risk from established tolerances and the proposed tolerance for
snap beans. Dietary risk assessments were conducted using the Reference
Dose (RfD) and the cancer potency factor for lactofen to assess chronic
risk from lactofen residues in the human diet.
The RfD for lactofen is 0.002 mg/kg of body weight/day. The RfD is
based on the lowest-observed effect level (1.5 mg/kg/day) from the 18-
month mouse feeding study and an uncertainty factor of 1,000. An
uncertainty factor of 1,000 was used to calculate the RfD since a NOEL
could not be established from the mouse study. Available information on
anticipated residues and/or percent of crop treated was used in the
analysis to estimate the Anticipated Residue Contribution (ARC) of
existing uses of lactofen and the proposed use on snap beans. The ARC
from existing uses and the proposed use utilizes less than 1 percent of
the RfD for the U.S. population and all population subgroups.
The upper-bound carcinogenic risk from dietary exposure to lactofen
is calculated at 4.3 x 10-7. The carcinogenic risk for lactofen
was calculated using the ARC estimates for dietary exposure from
existing uses and the proposed use on snap beans and a Q* of 0.16
(mg/kg/day)-1.
The nature of lactofen residues in snap beans is adequately defined
for purposes of this tolerance. The residues of concern in snap beans
are lactofen and its metabolites containing the diphenyl ether linkage.
An adequate analytical method is available for enforcement purposes.
The method is available in the Pesticide Analytical Manual, Volume II
(PAM II).
There are presently no actions pending against the continued
registration of this chemical.
Based on the information and data considered, the Agency has
determined that the tolerance established by amending 40 CFR part 180
would protect the public health. Therefore, it is proposed that the
tolerance be established as set forth below.
Any person who has registered or submitted an application for
registration of a pesticide, under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) as amended, which contains any of the
ingredients listed herein, may request within 30 days after publication
of this notice in the Federal Register that this rulemaking proposal be
referred to an Advisory Committee in accordance with section 408(e) of
the FFDCA.
A record has been established for this rulemaking under docket
number [PP 4E4418/P643] (including comments and data submitted
electronically as described below). A public version of this record,
including printed, paper versions of electronic comments, which does
not include any information claimed as CBI, is available for inspection
from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The public record is located in Room 1132 of the Public
Response and Program Resources Branch, Field Operations Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
Crystal Mall #2,
[[Page 9401]]
1921 Jefferson Davis Highway, Arlington, VA.
Electronic comments can be sent directly to EPA at:
opp-D[email protected]
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption.
The official record for this rulemaking, as well as the public
version, as described above will be kept in paper form. Accordingly,
EPA will transfer all comments received electronically into printed,
paper form as they are received and will place the paper copies in the
official rulemaking record which will also include all comments
submitted directly in writing. The official rulemaking record is the
paper record maintained at the address in ``ADDRESSES'' at the
beginning of this document.
Under Executive Order 12866 (58 FR 51735, Oct. 4, 1993), the Agency
must determine whether the regulatory action is ``significant'' and
therefore subject to all the requirements of the Executive Order (i.e.,
Regulatory Impact Analysis, review by the Office of Management and
Budget (OMB)). Under section 3(f), the order defines ``significant'' as
those actions likely to lead to a rule (1) having an annual effect on
the economy of $100 million or more, or adversely and materially
affecting a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local or tribal
governments or communities (also known as ``economically
significant''); (2) creating serious inconsistency or otherwise
interfering with an action taken or planned by another agency; (3)
materially altering the budgetary impacts of entitlement, grants, user
fees, or loan programs; or (4) raising novel legal or policy issues
arising out of legal mandates, the President's priorities, or the
principles set forth in this Executive Order.
Pursuant to the terms of this Executive Order, EPA has determined
that this rule is not ``significant'' and is therefore not subject to
OMB review.
Pursuant to the requirements of the Regulatory Flexibility Act
(Pub. L. 96-354, 94 Stat. 1164, 5 U.S.C. 601-612), the Administrator
has determined that regulations establishing new tolerances or raising
tolerance levels or establishing exemptions from tolerance requirements
do not have a significant economic impact on a substantial number of
small entities. A certification statement to this effect was published
in the Federal Register of May 4, 1981 (46 FR 24950).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 28, 1996.
Stephen L. Johnson,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR part 180 be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for Part 180 continues to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.432, Lactofen; tolerances for residues, by revising
paragraph (a) to read as follows:
Sec. 180.432 Lactofen; tolerances for residues.
(a) Tolerances are established for the combined residues of
lactofen, 1- (carboethoxy)ethyl-5-[2-chloro-4-
(trifluoromethyl)phenoxy]-2-nitrobenzoate, and its associated
metabolites containing the diphenyl ether linkage expressed as lactofen
in or on the following raw agricultural commodities:
------------------------------------------------------------------------
Parts
Commodities per
million
------------------------------------------------------------------------
Beans, snap.................................................... 0.05
Soybeans....................................................... 0.05
------------------------------------------------------------------------
* * * * *
[FR Doc. 96-5538 Filed 3-7-96; 8:45 am]
BILLING CODE 6560-50-F
Complete official Federal Register PDF
FR Doc. 96-5531 National Oil and Hazardous Substances Pollution Contingency Plan National Priorities List
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9403-9405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5531]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 300
[FRL-5436-8]
National Oil and Hazardous Substances Pollution Contingency Plan
National Priorities List
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of intent to delete A.L. Taylor Superfund Site, Brooks,
Kentucky from the National Priorities List.
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SUMMARY: The Environmental Protection Agency (EPA) Region 4 announces
its intent to delete the A.L. Taylor Site (the Site) from the National
Priorities List (NPL) and requests public comments on this proposed
action. In July, 1988, EPA issued a notice announcing its intent to
delete this Site. Prior to the final determination to delete the Site
the Agency adopted a policy of waiting until after a five-year review
of a site to consider delisting. The first five-year review of the A.L.
Taylor Site has been completed, and the results indicated that the
remedy is protective of the human health and environment. Therefore,
this notice is being revised to account for recent Site conditions. The
NPL constitutes Appendix B of 40 CFR part 300 which is the National Oil
and Hazardous Substances Contingency Plan (NCP), which EPA promulgated
pursuant to Section 105 of the Comprehensive Environmental Response,
Compensation and Liability Act of 1980 (CERCLA), as amended. EPA and
the Commonwealth of Kentucky have determined that the Site poses no
significant threat to public health and the environment and therefore,
further remedial measures pursuant to CERCLA are not appropriate.
DATES: Comments may be submitted by April 17, 1996.
ADDRESSES: Comments may be mailed to: Liza I. Montalvo, Remedial
Project Manager, North Superfund Remedial Branch, U.S. Environmental
Protection Agency, Region 4, 345 Courtland Street, N.E., Atlanta, GA
30365.
Comprehensive information on this Site is available through the
public docket which is available for viewing at the A.L. Taylor
Superfund Site information repositories at the following locations:
Ridgeway Memorial Library, 127 Walnut Street, Shepherdsville, KY,
40165.
U.S. EPA Record Center, 345 Courtland Street, N.E., Atlanta, GA,
30365.
FOR FURTHER INFORMATION CONTACT: Liza I. Montalvo, U.S. EPA Region 4,
345 Courtland St., N.E., Atlanta, GA 30365, 404-347-3555 Ext. 2030 or
1-800-435-9233 Ext. 2030.
SUPPLEMENTARY INFORMATION:
I. Introduction
The Environmental Protection Agency (EPA), Region 4, announces its
intent to delete the A.L. Taylor Site, Brooks, Kentucky, from the
National Priorities List (NPL), Appendix B of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR Part 300,
and requests comments on its deletion. EPA identifies sites that appear
to present a significant risk to public health, welfare, or the
environment and maintains the NPL as the list of these sites. As
described in Sec. 300.425(e)(3) of the NCP, sites deleted from the NPL
remain eligible for remedial actions in the unlikely event that
conditions at the site warrant such action.
The EPA will accept comments on the proposal to delete this Site
for thirty days after publication of this notice in the Federal
Register.
Section II of this notice explains the criteria for deleting sites
from the NPL. Section III discusses the procedures that EPA is using
for this action. Section IV discusses the A.L. Taylor Superfund Site
and explains how the Site meets the deletion criteria.
II. NPL Deletion Criteria
Section 300.425(e) of the NCP provides that releases may be deleted
from, or recategorized on the NPL where no further response is
appropriate. In making a determination to delete a release from the
NPL, EPA shall consider, in consultation with the State, whether any of
the following criteria have been met:
(i) Responsible parties or other persons have implemented all
appropriate response actions required;
(ii) All appropriate fund-financed response under CERCLA have been
implemented, and no further action by responsible parties is
appropriate; or
(iii) The remedial investigation has shown that the release poses
no significant threat to public health or the environment and,
therefore, taking of remedial measures is not appropriate.
Even if a site is deleted from the NPL, where hazardous substances,
pollutants, or contaminants remain at the site above levels that allow
for unlimited use and unrestricted exposure, EPA's policy is that a
subsequent review of the site will be conducted at least every five
years after the initiation of the remedial action at the site to ensure
that the site remains protective of public health and the environment.
[[Page 9404]]
III. Deletion Procedures
The following procedures were used for the intended deletion of
this Site: (1) EPA Region 4 has recommended deletion and has prepared
the relevant documents, (2) The Commonwealth of Kentucky has concurred
with the deletion decision, (3) Concurrent with this Revised Notice of
Intent to Delete, a local notice has been published in local newspapers
and has been distributed to appropriate federal, state and local
officials, and other interested parties. This local notice announces a
thirty (30) day public comment period, provides an address and
telephone number for submission of comments, and identifies the
location of the local site repository; and (4) Region 4 has made all
relevant documents available in the Regional Office and local site
information repository.
Deletion of the Site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. The NPL is designed
primarily for informational purposes and to assist Agency management.
As mentioned in Section II of this Notice, Sec. 300.425(e)(3) of the
NCP states that the deletion of a site from the NPL does not preclude
eligibility for future response actions.
For deletion of this Site, EPA Region 4 will accept and evaluate
public comments on EPA's Revised Notice of Intent to Delete before
making a final decision to delete. If necessary, the Agency will
prepare a Responsiveness Summary to address any significant public
comments received.
A deletion occurs when the EPA Regional Administrator places a
final action in the Federal Register. Generally, the NPL will reflect
deletions in the final update following the notice. Public notices and
copies of the Responsiveness Summary will be made available to local
residents by Region 4.
IV. Basis for Intended Site Deletion
The following Site summary provides the Agency's rational for the
proposal to delete this Site from the NPL.
A. Site Background
The A.L. Taylor Site, sometimes referred to as ``The Valley of the
Drums,'' is a 13-acre site located in Brooks, Bullitt County, Kentucky,
near the community of Brooks. The Site is approximately 1.3 miles west
of Interstate 65 and 1.7 miles northwest of Brooks, Kentucky, off of
State Highway 1020. The Site is bordered to the north and west by woods
and to the south and east by several private rural residences and a
golf course.
B. History
The A.L. Taylor Site was first identified as a waste disposal site
by the Kentucky Department of Natural Resources and Environmental
Protection Cabinet (KDNREPC) in 1967. The paint and coating industries
in the Louisville area were the primary waste generators using the
Site. Solvent wastes, from these generators, were disposed in drums by
burning the wastes in the open pits. Some drums were emptied into open
pits, cleaned and recycled. Soil from the nearby hillsides was used to
cover the pits. During the later years of operation, thousands of drums
were stored on the ground surface.
KDNREPC first became involved with the Site in 1967 after receiving
reports of a fire that had been burning for approximately one week.
After investigating the Site, the State noted that an approved sanitary
landfill could be operated by Mr. A.L. Taylor at this location with
proper permitting. However, Mr. Taylor did not apply for a sanitary
landfill permit, and continued receiving and disposing of waste on the
Site, under the business name of the A.L. Taylor Drum Cleaning Service,
until November 1977.
In January 1979, at the request of KDNREPC, EPA responded to
releases of oil and hazardous substances at the A.L. Taylor Site. Under
the authority of Section 311 of the Clean Water Act, the EPA Emergency
Response Branch addressed the releases of pollutants into Wilson Creek
by constructing interceptor trenches and a temporary water treatment
system, securing leaking drums, and segregating and organizing drums on
site. The EPA operated and maintained the temporary treatment system on
site until December 1979, when the KDNREPC assumed responsibility for
the system.
The EPA's final count of drums located on the Site after the 1979
emergency response action was 17,051 drums, of which 11,628 were empty.
In 1980, KDNREPC contacted five Responsible Parties who identified and
removed approximately 20 percent of the drummed waste remaining on the
surface. The five generators contacted include: Ford Motor Co.;
Reliance Universal, Inc.; Louisville Varnish Co.; George W. Whitesides
Co.; and Kurfee's Coating, Inc. Following this removal, about 4,200
drums remained.
C. Characterization of Risk
In 1981, an EPA inspection revealed that deteriorated and leaking
drums, were again discharging pollutants into Wilson Creek. EPA,
responding under the emergency provisions of CERCLA, upgraded the
existing treatment system and moved the remaining 4,200 drums from the
Site for recycling or disposal. The Site was then regraded to promote
positive drainage towards Wilson Creek, thus reducing the amount of
ponded water and minimizing surface erosion. Although, these measures
eliminated the drummed waste from the surface, contaminated soils and
buried drums remained on site.
Analytical data was collected during several site actions,
including the two immediate removals and the Remedial Investigation. In
all, approximately 140 compounds were identified. The chemicals found
most often and in the highest concentrations were: xylene; acetone;
toluene; phthalates; methyl ethyl ketone; vinyl chloride; fluoranthene;
dichloroethylene; methylene chloride; anthracene; alkyl benzene;
aliphatic acids.
PCBs were detected in low concentrations and several metals,
including barium, zinc, copper, strontium, magnesium, and chromium,
were detected in concentrations exceeding background levels.
The highest concentrations of organic contaminants detected on-
site, other than from drum samples, were from liquid samples collected
in pits which EPA constructed to test for subsurface contamination.
Some of the same compounds were detected in water samples from borings
located down-gradient of these test pits. A Feasibility Study was
completed in 1982 by Ecology and Environment, Inc., and a Record of
Decision (ROD) was finalized by EPA in June 1986. The ROD identified
groundwater and surface water (Wilson Creek) as potential routes of
exposure to hazardous substances, and selected a final remedy for the
Site.
In April 1987, the remedial measures selected in the ROD were
commenced by Haztech, Inc. These measures included the installation of
a clay cap, a perimeter drainage system, monitoring wells, and a
security fence.
In the fall of 1988, reseeding and regrading of the cap was found
to be necessary due to erosion problems. In March 1989, all remedial
construction was completed.
D. Operation and Maintenance
Operations and Maintenance (O&M) activities were performed by
Ebasco Services, Inc. The O&M activities included groundwater sampling
over five quarters from September 1988, through February 1990. The
Commonwealth of Kentucky will be conducting the remaining 29 years of
routine O&M with funds they received
[[Page 9405]]
from a cost recovery settlement with responsible parties for the Site.
E. Five-Year Review
EPA finalized the first Five-Year Review for the A.L. Taylor Site
in June 1992, in which groundwater, surface water, leachate, sediment
and gas samples were collected. The review concluded that the remedy
was still protective of the human health and environment.
F. State Concurrence to Delete A.L. Taylor Site
EPA, with concurrence of the Commonwealth of Kentucky, believes
that the following criterion for deletion have been met: (1) EPA has
implemented all appropriate response actions required; and (2) All
appropriate response under CERCLA has been implemented. Consequently,
EPA is proposing deletion of A.L. Taylor Site from the NPL. Documents
supporting this action are available from the docket.
Dated: February 20, 1996.
Phyllis P. Harris,
Acting Regional Administrator, U.S. EPA Region 4.
[FR Doc. 96-5531 Filed 3-7-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-5530 National Oil and Hazardous Substances Pollution Contingency Plan National Priorities List
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9401-9403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5530]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 300
[FRL-5436-5]
National Oil and Hazardous Substances Pollution Contingency Plan
National Priorities List
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of intent to delete Newport Dump Superfund Site, Wilder,
Kentucky, from the National Priorities List.
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SUMMARY: The Environmental Protection Agency (EPA) Region 4 announces
its intent to delete the Newport Dump Site (the Site) from the National
Priorities List (NPL) and requests public comments on this proposed
action. On May 16, 1988, EPA issued a notice announcing its intent to
delete this site and others. The notice is being revised to conform to
the most recent Site conditions. The NPL constitutes Appendix B of 40
CFR part 300 which is the National Oil and Hazardous Substances
Contingency Plan (NCP), which EPA promulgated pursuant to Section 105
of the Comprehensive Environmental Response, Compensation and Liability
Act of 1980 (CERCLA), as amended. EPA and the Commonwealth of Kentucky
have determined that the Site poses no significant threat to public
health and the environment and therefore, further remedial measures
pursuant to CERCLA are not appropriate.
DATES: Comments may be submitted by midnight April 17, 1996.
ADDRESSES: Comments may be mailed to: Liza I. Montalvo, Remedial
Project Manager, North Superfund Remedial Branch, U.S. Environmental
Protection Agency, Region 4, 345 Courtland Street, N.E., Atlanta, GA
30365.
Comprehensive information on this Site is available through the
public docket which is available for viewing at the Newport Dump site
information repositories at the following locations:
Campbell County Library, 403 Monmouth, Newport, KY, 41071.
U.S. EPA Record Center, 345 Courtland Street, N.E., Atlanta, GA, 30365.
FOR FURTHER INFORMATION CONTACT: Liza I. Montalvo, U.S. EPA Region 4,
345 Courtland St., N.E., Atlanta, GA 30365, 404-347-3555 Ext. 2030 or
1-800-435-9233 Ext. 2030.
SUPPLEMENTARY INFORMATION:
I. Introduction
The Environmental Protection Agency (EPA) Region 4 announces its
intent to delete the Newport Dump site, Wilder, Kentucky, from the
National Priorities List (NPL), Appendix B of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP), 40 CFR part 300,
and requests comments on its deletion. EPA identifies sites that appear
to present a significant risk to public health, welfare, or the
environment and maintains the NPL as the list of these sites. As
described in Sec. 300.425(e)(3) of the NCP, sites deleted from the NPL
remain eligible for remedial actions in the unlikely event that
conditions at the site warrant such action.
The EPA will accept comments on the proposal to delete this Site
for thirty days after publication of this notice in the Federal
Register.
Section II of this notice explains the criteria for deleting sites
from the NPL. Section III discusses the procedures that
[[Page 9402]]
EPA is using for this action. Section IV discusses the Newport Dump
Site and explains how the Site meets the deletion criteria.
II. NPL Deletion Criteria
Section 300.425(e) of the NCP provides that releases may be deleted
from, or recategorized on the NPL where no further response is
appropriate. In making a determination to delete a release from the
NPL, EPA shall consider, in consultation with the state, whether any of
the following criteria have been met:
(i) Responsible parties or other parties have implemented all
appropriate response actions required;
(ii) All appropriate responses under CERCLA have been implemented,
and no further action by responsible parties is appropriate; or
(iii) The remedial investigation has shown that the release poses
no significant threat to public health or the environment and,
therefore, taking of remedial measures is not appropriate.
Even if a site is deleted from the NPL, where hazardous substances,
pollutants, or contaminants remain at the site above levels that allow
for unlimited use and unrestricted exposure, EPA's policy is that a
subsequent review of the site will be conducted at least every five
years after the initiation of the remedial action at the site to ensure
that the site remains protective of public health and the environment.
III. Deletion Procedures
The following procedures were used for the intended deletion of
this site: (1) EPA Region 4 has recommended deletion and has prepared
the relevant documents, (2) The Commonwealth of Kentucky has concurred
with the deletion decision, (3) Concurrent with this Revised Notice of
Intent to Delete, a local notice has been published in local newspapers
and has been distributed to appropriate federal, state and local
officials, and other interested parties. This local notice announces a
thirty (30) day public comment period, provides an address and
telephone number for submission of comments, and identifies the
location of the local site repository; and (4) Region 4 has made all
relevant documents available in the Regional Office and local site
information repository.
Deletion of the Site from the NPL does not itself create, alter, or
revoke any individual's rights or obligations. The NPL is designed
primarily for informational purposes and to assist Agency management.
As mentioned in Section II of this Notice, Sec. 300.425(e)(3) of the
NCP states that the deletion of a site from the NPL does not preclude
eligibility for future response actions.
For deletion of this Site, EPA Region 4 will accept and evaluate
public comments on EPA's Revised Notice of Intent to Delete before
making a final decision to delete. If necessary, the Agency will
prepare a Responsiveness Summary to address any significant public
comments received.
A deletion occurs when the EPA Regional Administrator places a
final action in the Federal Register. Generally, the NPL will reflect
deletions in the final update following the Notice. Public notices and
copies of the Responsiveness Summary will be made available to local
residents by Region 4.
IV. Basis for Intended Site Deletion
The following site summary provides the Agency's rationale for the
proposal to delete this Site from the NPL.
A. Site Background
The Newport Dump Site is a former municipal landfill located in the
City of Wilder in Campbell County, Kentucky. Contiguous to the western
boundary of the Site is the Licking River, a tributary of the Ohio
River.
B. History
The 39 acre Site was originally used by the City of Newport for the
disposal of residential and commercial wastes from its opening in the
late 1940's until its closure in 1979. During this period the Kentucky
Department of Natural Resources and Environmental Protection Cabinet
(KDNREPC) cited the City of Newport for numerous waste disposal
violations and the Site was eventually purchased by the Northern
Kentucky Port Authority. In 1982, the Newport Dump Site was evaluated
by the Hazard Ranking System (HRS) and received a score of 37.96 which
ranked the Site number 359 in Group 8 on the National Priorities List
(NPL). The basis for this NPL ranking was that the Newport Dump Site
contained over 1,000,000 cubic yards of both hazardous and non-
hazardous commercial waste, the Site was adjoined on both the south and
west boundaries by surface water stream and river, respectively and
across the Licking River on the west was a potable water intake serving
75,000 nearby residents.
C. Characterization of Risk
A Remedial Investigation and Feasibility Study ensued and
discovered several inorganic contaminants, i.e., barium, chromium,
nickel and organic compound, toluene, were leaching into the Licking
River slightly above health base levels established by the Clean Water
Act's Maximum Contaminant Levels (MCLs). A Record of Decision (ROD)
signed at EPA Region 4, Atlanta, Georgia on March 27, 1987 selected the
following response: monitoring groundwater and subsurface gas
migration, construction of a leachate collection system and regrading
revegetation of the 39 acre Site to prevent erosion. An Action Memo to
authorize a removal action was signed in June 1987. This remedy was
constructed and placed into operation within seven (7) months of the
signing of the ROD and completed during December 1987. Groundwater,
surface water, soil and sediment sampling were accomplished during the
construction and post construction phases. Except for the waste source,
the sampling results listed negligible (well below the MCL criteria) to
non-detectable contaminant levels in the adjacent Licking River, and in
both on-site and off-site media demonstrated no significant or
potentially harmful migration of contaminants to off-site receptors.
D. Operation and Maintenance
EPA Region 4 has performed the first year of Operation and
Maintenance (O&M) activities as mandated in the ROD, which included
multimedia monitoring of groundwater, surface water, underground gas
migration, and leachate. In October 1992, the City of Newport entered
into an agreement with EPA Region 4 to continue to perform O&M work at
the Site. The City of Newport began such activities in June 1993.
E. Five-Year Review
EPA finalized the first Five-Year Review for the Newport Dump Site
in July 1993, in which groundwater, surface water, leachate, sediment
and gas samples were collected. Groundwater data was compared to the
MCL (July 1992), the Alternate Concentration Limits in the Newport ROD,
and background levels. Surface Water data was evaluated using MCLs,
July 1992, Water Quality Criteria (WQC), December, 1992 and Kentucky
Surface Water Standards, January 1992. It was concluded that the
contaminants detected in the ground water, surface water, and sediment
do not pose a threat to human health and the environment, and that
there appears to be no contribution from the landfill to these medias.
Subsurface gas samples were analyzed for volatile organic compounds
(VOCs) and methane. Hazardous gases were detected in three of the gas
wells, however, only methane was detected above its lower explosive
limit (LEL). These wells will continue to
[[Page 9403]]
be monitored, and methane field screening techniques will be performed
on a quarterly basis to ensure gas is not migrating off-site.
F. Explanation of Significant Differences
In January 1995, EPA Region 4 issued an Explanation of Significant
Differences (ESD) for the Newport Dump Site to provide information on
modifications to the selected remedy as originally described in the
ROD, and to notify the public of O&M activities being conducted at the
Site. The actions documented in the ESD included: the installation of a
new drainage culvert, the construction of a french drain, and the shut
down of the leachate collection system. In May 1990, EPA Region 4
discontinued use of the leachate collection system because it appeared
to be collecting groundwater, and operating the system was not
providing a higher degree of protection to the environment. Since
turning the system off, no problems have been encountered, and no
significant increases in contamination in the surface water in the
Licking River have occurred. In fact, the levels of contaminants in the
leachate samples collected in the Five-Year Review were consistent with
the surrounding groundwater.
At this time, all appropriate Fund-financed response under CERCLA
has been implemented, and no further response action by responsible
parties is appropriate.
G. State Concurrence to Delete Newport Dump Site
EPA, with concurrence of the Commonwealth of Kentucky, believes
that the following criterion for deletion have been met: (1) EPA has
implemented all appropriate response actions required; and (2) All
appropriate response under CERCLA has been implemented. Subsequently,
EPA is proposing deletion of Newport Dump Site from the NPL. Documents
supporting this action are available from the docket.
Dated: February 23, 1996.
Phyllis P. Harris,
Acting Regional Administrator, U.S. EPA Region 4.
[FR Doc. 96-5530 Filed 3-7-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-5526 Airworthiness Directives; Jetstream BAe Model ATP Airplanes
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9371-9373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5526]
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DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. 95-NM-160-AD]
Airworthiness Directives; Jetstream BAe Model ATP Airplanes
AGENCY: Federal Aviation Administration, DOT.
ACTION: Notice of proposed rulemaking (NPRM).
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SUMMARY: This document proposes the adoption of a new airworthiness
directive (AD) that is applicable to certain Jetstream BAe Model ATP
airplanes. This proposal would require repetitive inspections to detect
damage of the antenna mounting reinforcing plates and surrounding
fuselage skin. If any damage is detected, the proposed AD would require
replacement of the reinforcing plate with a new reinforcing plate and/
or repair the surrounding fuselage skin, which would terminate the
repetitive inspection requirements. This proposal is prompted by
reports of corrosion found at the antenna reinforcing plates, which was
caused by the ingress of water at the plates. The actions specified by
the proposed AD are intended to prevent such corrosion, which could
result in reduced structural integrity of the fuselage pressure vessel.
DATES: Comments must be received by April 18, 1996.
ADDRESSES: Submit comments in triplicate to the Federal Aviation
Administration (FAA), Transport Airplane Directorate, ANM-103,
Attention: Rules Docket No. 95-NM-160-AD, 1601 Lind Avenue, SW.,
Renton, Washington 98055-4056. Comments may be inspected at this
location between 9:00 a.m. and 3:00 p.m., Monday through Friday, except
Federal holidays.
The service information referenced in the proposed rule may be
obtained from Jetstream Aircraft, Inc., P.O. Box 16029,
[[Page 9372]]
Dulles International Airport, Washington, DC 20041-6029. This
information may be examined at the FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington.
FOR FURTHER INFORMATION CONTACT: William Schroeder, Aerospace Engineer,
Standardization Branch, ANM-113, FAA, Transport Airplane Directorate,
1601 Lind Avenue, SW., Renton, Washington 98055-4056; telephone (206)
227-2141; fax (206) 227-1149.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to participate in the making of the
proposed rule by submitting such written data, views, or arguments as
they may desire. Communications shall identify the Rules Docket number
and be submitted in triplicate to the address specified above. All
communications received on or before the closing date for comments,
specified above, will be considered before taking action on the
proposed rule. The proposals contained in this notice may be changed in
light of the comments received.
Comments are specifically invited on the overall regulatory,
economic, environmental, and energy aspects of the proposed rule. All
comments submitted will be available, both before and after the closing
date for comments, in the Rules Docket for examination by interested
persons. A report summarizing each FAA-public contact concerned with
the substance of this proposal will be filed in the Rules Docket.
Commenters wishing the FAA to acknowledge receipt of their comments
submitted in response to this notice must submit a self-addressed,
stamped postcard on which the following statement is made: ``Comments
to Docket Number 95-NM-160-AD.'' The postcard will be date stamped and
returned to the commenter.
Availability of NPRMs
Any person may obtain a copy of this NPRM by submitting a request
to the FAA, Transport Airplane Directorate, ANM-103, Attention: Rules
Docket No. 95-NM-160-AD, 1601 Lind Avenue, SW., Renton, Washington
98055-4056.
Discussion
The Civil Aviation Authority (CAA), which is the airworthiness
authority for the United Kingdom, recently notified the FAA that an
unsafe condition may exist on certain Jetstream BAe Model ATP
airplanes. The CAA has received a report indicating that corrosion was
found on at least two airplanes at the antenna reinforcing plates. The
cause of such corrosion has been attributed to the ingress of water at
the plates. Corrosion of the antenna reinforcing plates, if not
detected and corrected in a timely manner, could result in reduced
structural integrity of the fuselage pressure vessel.
Jetstream has issued Service Bulletin ATP-53-31, dated July 1,
1995, which describes procedures for repetitive detailed external
visual inspections to detect damage (i.e., corrosion, cracks,
pillowing, and rivet pulling) of the antenna mounting reinforcing
plates and surrounding fuselage skin. For cases where any damage is
detected during the inspection, the service bulletin describes
procedures for replacement of the reinforcing plate with a new
reinforcing plate and/or repair the surrounding fuselage skin.
Accomplishment of the replacement/repair would eliminate the need for
the repetitive inspections. The CAA classified this service bulletin as
mandatory in order to assure the continued airworthiness of these
airplanes in the United Kingdom.
This airplane model is manufactured in the United Kingdom and is
type certificated for operation in the United States under the
provisions of section 21.29 of the Federal Aviation Regulations (14 CFR
21.29) and the applicable bilateral airworthiness agreement. Pursuant
to this bilateral airworthiness agreement, the CAA has kept the FAA
informed of the situation described above. The FAA has examined the
findings of the CAA, reviewed all available information, and determined
that AD action is necessary for products of this type design that are
certificated for operation in the United States.
Since an unsafe condition has been identified that is likely to
exist or develop on other products of this same type design, the
proposed AD would require repetitive detailed external visual
inspections to detect damage (i.e., corrosion, cracks, pillowing, and
rivet pulling) of the antenna mounting reinforcing plates and
surrounding fuselage skin. For cases where any damage is detected
during the inspection, the proposed AD would require replacement of the
reinforcing plate with a new reinforcing plate and/or repair the
surrounding fuselage skin; this replacement/repair would constitute
terminating action for the repetitive inspection requirements. The
actions would be required to be accomplished in accordance with the
service bulletin described previously.
The FAA estimates that 10 airplanes of U.S. registry would be
affected by this proposed AD, that it would take approximately 2 work
hours per airplane to accomplish the proposed actions, and that the
average labor rate is $60 per work hour. Based on these figures, the
cost impact of the proposed AD on U.S. operators is estimated to be
$1,200, or $120 per airplane, per inspection cycle.
The cost impact figure discussed above is based on assumptions that
no operator has yet accomplished any of the proposed requirements of
this AD action, and that no operator would accomplish those actions in
the future if this AD were not adopted.
The regulations proposed herein would not have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Therefore, in
accordance with Executive Order 12612, it is determined that this
proposal would not have sufficient federalism implications to warrant
the preparation of a Federalism Assessment.
For the reasons discussed above, I certify that this proposed
regulation (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under the DOT
Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
and (3) if promulgated, will not have a significant economic impact,
positive or negative, on a substantial number of small entities under
the criteria of the Regulatory Flexibility Act. A copy of the draft
regulatory evaluation prepared for this action is contained in the
Rules Docket. A copy of it may be obtained by contacting the Rules
Docket at the location provided under the caption ADDRESSES.
List of Subjects in 14 CFR Part 39
Air transportation, Aircraft, Aviation safety, Safety.
The Proposed Amendment
Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:
PART 39--AIRWORTHINESS DIRECTIVES
1. The authority citation for part 39 continues to read as follows:
Authority: 49 USC 106(g), 40113, 44701.
[[Page 9373]]
Sec. 39.13 [Amended]
2. Section 39.13 is amended by adding the following new
airworthiness directive:
Jetstream Aircraft Limited (Formerly British Aerospace Commercial
Aircraft Limited): Docket 95-NM-160-AD.
Applicability: BAe Model ATP airplanes having constructor's
numbers 2002 through 2063 inclusive, certificated in any category.
Note 1: This AD applies to each airplane identified in the
preceding applicability provision, regardless of whether it has been
modified, altered, or repaired in the area subject to the
requirements of this AD. For airplanes that have been modified,
altered, or repaired so that the performance of the requirements of
this AD is affected, the owner/operator must request approval for an
alternative method of compliance in accordance with paragraph (c) of
this AD. The request should include an assessment of the effect of
the modification, alteration, or repair on the unsafe condition
addressed by this AD; and, if the unsafe condition has not been
eliminated, the request should include specific proposed actions to
address it.
Compliance: Required as indicated, unless accomplished
previously.
To prevent corrosion of the antenna mounting reinforcing plates
and surrounding skin, which could result in reduced structural
integrity of the fuselage pressure vessel, accomplish the following:
(a) Within 6 months after the effective date of this AD, perform
a detailed external visual inspection to detect damage (i.e.,
corrosion, cracks, pillowing, and rivet pulling) of the antenna
mounting reinforcing plates and surrounding fuselage skin in
accordance with PART A of the Accomplishment Instructions of
Jetstream Service Bulletin ATP-53-31, dated July 1, 1995.
(1) If no damage is detected, repeat the inspection thereafter
at intervals not to exceed 1 year.
(2) If any damage is detected, replace the reinforcing plate
with a new reinforcing plate and/or repair the surrounding fuselage
skin at the applicable times specified in Figure 4 of the service
bulletin, and in accordance with PART B of the Accomplishment
Instructions of the service bulletin. Accomplishment of the
replacement/repair constitutes terminating action for the repetitive
inspection requirements of paragraph (a) of this AD.
(b) Accomplishment of the replacement/repair procedures
specified in PART B of the Accomplishment Instructions of Jetstream
Service Bulletin ATP-53-31, dated July 1, 1995, constitutes
terminating action for the requirements of this AD.
(c) An alternative method of compliance or adjustment of the
compliance time that provides an acceptable level of safety may be
used if approved by the Manager, Standardization Branch, ANM-113,
FAA, Transport Airplane Directorate. Operators shall submit their
requests through an appropriate FAA Principal Maintenance Inspector,
who may add comments and then send it to the Manager,
Standardization Branch, ANM-113.
Note 2: Information concerning the existence of approved
alternative methods of compliance with this AD, if any, may be
obtained from the Standardization Branch, ANM-113.
(d) Special flight permits may be issued in accordance with
sections 21.197 and 21.199 of the Federal Aviation Regulations (14
CFR 21.197 and 21.199) to operate the airplane to a location where
the requirements of this AD can be accomplished.
Issued in Renton, Washington, on March 4, 1996.
James V. Devany,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 96-5526 Filed 3-7-96; 8:45 am]
BILLING CODE 4910-13-U
Complete official Federal Register PDF
FR Doc. 96-5519 Occupational Exposure to 1,3-Butadiene
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9380-9383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5519]
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[[Page 9381]]
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1910, 1915 and 1926
[Docket No. H-041]
Occupational Exposure to 1,3-Butadiene
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Proposed Rule; Limited reopening of the rulemaking record.
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SUMMARY: The Occupational Safety and Health Administration is reopening
the record for the proposed revision of the 1,3-Butadiene (BD) standard
to solicit public comment on a joint labor/industry agreement dated
January 29, 1996, recommending that OSHA reduce the permissible
exposure limits and expanding on some provisions that were addressed in
OSHA's 1990 proposal (55 FR 32736, August 10, 1990). In addition, OSHA
is seeking comment on possible changes in the medical surveillance
requirements, including reliance on a medical questionnaire that would
replace some of the proposed yearly medical examinations and reduce the
need for medical removal protection. Finally, the Agency is entering
into the rulemaking record four documents that have become available
since the submission deadline of December 13, 1991, set by the
Administration Law Judge following the rulemaking hearings.
DATES: Written comments must be postmarked by April 8, 1996.
ADDRESSES: Comments are to be submitted in quadruplicate to the Docket
Office, Docket No. H-041, U.S. Department of Labor, Room N-2634, 200
Constitution Avenue, NW., Washington, DC 20210. Telephone (202) 219-
7894. Written comments limited to 10 pages or less in length may also
be transmitted by facsimile to (202) 219-5046, provided the original
and 3 copies are sent to the Docket Office thereafter.
Copies of the labor/industry agreement and submissions to the
record along with other information cited in this notice are available
for inspection and copying in the Docket Office. For electronic copies
of this notice, contact the Labor News Bulletin Board (202) 219-4784;
or OSHA's WebPage on the Internet at http://www.osha.gov/. For news
releases, fact sheets, and other short documents, contact OSHA FAX at
(900) 555-3400 at $1.50 per minute.
FOR FURTHER INFORMATION CONTACT:
Anne C. Cyr, Office of Information and Consumer Affairs, Occupational
Safety and Health Administration, U.S. Department of Labor, Room N-
3647, 200 Constitution Avenue, NW., Washington, DC 20210. Telephone
(202) 219-8148.
SUPPLEMENTARY INFORMATION:
I. Background
A. History
The present OSHA standard for BD requires employers to ensure that
employee exposure does not exceed 1,000 ppm determined as an 8-hour
time weighted average (TWA) (29 CFR 1910.1000, Table Z-1).
In 1983, the American Conference of Governmental Industrial
Hygienists (ACGIH) classified BD as an animal carcinogen based on a
National Toxicology Program (NTP) animal study showing that BD caused
cancer in rodents. The ACGIH recommended that employee exposures be
reduced to or below 10 ppm (8-hr TWA). In 1984, the United Rubber,
Cork, Linoleum and Plastic Workers of America (URW), the Oil, Chemical
and Atomic Workers, and the American Federation of Labor and Congress
of Industrial Organizations (AFL-CIO) petitioned OSHA to issue an
Emergency Temporary Standard (ETS) of 1 ppm or less. OSHA denied the
petition for an ETS, but began collecting information in order to
institute rulemaking under Section 6(b) of the Occupational Safety and
Health Act. The Environmental Protection Agency (EPA) was also studying
the health hazards of BD. That agency's analysis found that BD was a
probable human carcinogen and that workplace exposures presented an
unreasonable risk of injury to human health. Because exposures to BD
occurred primarily in the workplace, EPA, in accordance with section
9(a) of the Toxic Substances Control Act, referred BD to OSHA to give
this Agency an opportunity to regulate the chemical under the OSH Act.
(50 FR 41393; October 10, 1985).
On August 10, 1990, OSHA issued a notice of proposed rulemaking (55
FR 32736) to address the significant occupational risks of BD-induced
health effects. The proposed rule required employers to reduce
occupational exposure to BD to 2 ppm as an 8-hour TWA and 10 ppm as a
15-minute short term exposure limit (STEL), and to institute ancillary
measures, such as employee training and medical surveillance, for
further protection of BD-exposed workers.
OSHA convened public hearings in Washington, DC, on January 15-23,
1991, and in New Orleans, Louisiana, on February 20-21-1991. The post-
hearing period for the submission of briefs, arguments and summations
was to end July 22, 1991, but was extended by the Administrative Law
Judge to December 13, 1991, in order to give participants time to
review new data on low-dose exposure submitted by NTP and a
quantitative risk assessment done by NIOSH.
B. The Labor/Industry Agreement
To assist OSHA in issuing a final rule for BD, representatives of
the major unions and industry groups involved in the production and use
of BD submitted a voluntary agreement reached by the parties dated
January 29, 1996, on provisions that should be included in the
standard. The letter transmitting the agreement was signed by J.L.
McGraw for the International Institute of Synthetic Rubber Producers,
Michael J. Wright for the United Steelworkers of America and Michael
Sprinker for the International Chemical Workers Union. The committee
that worked on the issues also included Joseph Holtshouser of the
Goodyear Tire and Rubber Company, Carolyn Phillips of the Shell
Chemical Company, representing the Chemical Manufacturers Association,
Robert Richmond of the Firestone Synthetic Rubber and Latex Company,
and Louis Beliczsky (formerly of the URW) and James L. Frederick of the
United Steelworkers. OSHA is pleased that labor and industry have
joined together to recommend regulatory requirements that can lead to
lower and less frequent exposures for employees who work with or near
BD.
The agreement proposes a significant change in the permissible
exposure limits, additional provisions for exposure monitoring, and an
exposure goal program designed to reduce exposures below the action
level. It also proposes other modifications to the scope, respiratory
protection, communication of hazards, medical surveillance, and start-
up dates sections of the final rule. The agreement also assumes that
items not specifically addressed in the agreement will remain as
proposed. OSHA reprints the provisions below in order to allow the
public an opportunity to provide the Agency with comments.
1, 3-Butadiene
Recommended Revisions to OSHA's Proposed Standard Scope and
Application: Exclude [from the final rule's coverage]:
1. Products with BD concentration of 0.1% or less by volume unless
objective data shows exposure could exceed the
[[Page 9382]]
AL [action level] or STEL [short-term exposure level].
2. Storage, transportation, distribution or sale of BD in intact
containers or pipelines, except for labeling requirements and emergency
response provisions.
Definitions: Objective Data means monitoring data or mathematical
calculations or modeling based on the chemical and physical properties
of the material, stream or product.
Limits:
1. Action level (AL) of 0.5 ppm [parts per million] (ppm) as an 8-
hour TWA.
2. Permissible Exposure Limit (PEL) of 1 ppm as an 8 hr TWA.
3. Short Term Exposure Limit (STEL) of 5 ppm [sampled] for 15
minutes.
Exposure Monitoring:
1. Establish a baseline of at least 8 samples. The samples may be
taken in a single year, so long as at least one sample is taken in each
quarter, and no two are taken within 30 days of each other. The
employer may utilize monitoring data from the previous two years to
satisfy the initial monitoring requirement as long as [the] process has
been consistent.
2. After the baseline has been established, monitoring is
[required]:
a. Every 6 months if exposure exceeds PEL or STEL.
b. Annually if exposure is at or above the AL but below the PEL.
Additional Monitoring: May use direct reading instruments for any
spills, leaks, etc. to ensure that levels have returned to normal
following an emergency.
Employee Notification: Five (5) day [period for] employee
notification of sampling results.
Exposure Goal Program: The employer shall institute an ``exposure
goal program'' which attempts to limit exposure levels to or below the
action level. No exposure goal program is required if all exposures are
at or below the action level. The program shall include the following
controls, unless the employer can demonstrate that they will not be
feasible or effective.
a. A leak prevention, detection, and repair program.
b. A program for maintaining the integrity of local exhaust
ventilation systems.
c. The use of pump exposure control technology such as, but not
limited to, double-sealed or seal-less pumps.
d. Gauging devices designed to limit employee exposure, such as
magnetic gauges on rail cars.
e. Unloading devices designed to limit employee exposure, such as
vapor return systems.
f. Maintaining control rooms below the AL by use of engineering
controls.
Respirators:
1. Use when exposure may exceed PEL or STEL.
2. Fit testing as per ANSI standards.
3. Allow \1/2\ face negative pressure respirators for certain
applications.
Medical Surveillance:
1. Medical evaluations for all employees exposed above the PEL for
30 days or more, or above the AL for 60 days or more.
2. Medical evaluations for formerly-exposed employees whose work
history includes exposure as defined in (1) for 10 year or more, or
exposure above 10 ppm as an 8-hr TWA for more than 30 days in any past
year, so long as they continue to be employed by the employer
responsible for the exposure, or a successor owner.
3. An exam with respect to acute effects as quickly as possible in
the case of exposure from a significant release.
4. Appropriate exams for respirator wearers in accord with 29
C.F.R. 1910.134.
5. Medical evaluations include an update of medical history [and] a
CBC [complete blood count] including platelets. Additional tests are
deemed appropriate by the examining physician. Remove references to
fertility evaluations.
Communication of BD Exposure to Employees: Modify warning signs and
label requirements to eliminate reproductive/lung/kidney reference.
Employee Training: Required annually or with change of job when
exposure may reach PEL, STEL or AL.
Dates: Employer may take up to two (2) years from effective dates
to implement engineering controls.
Appendices: OSHA should also correct certain misstatements in
Appendices A and B:
Appendix A, Part IV(B): The sentence; ``Any clothing which becomes
wet with liquid BD should be removed immediately * * *'' should be
deleted. BD evaporates too rapidly to cause wet clothing.
Appendix B, Part II(A)(6): The statement that ``vapors of BD will
burn without the presence of air or other oxidizers'' is incorrect.
Appendix B, Part III(A)(3): The suggestion that spills of small
quantities of BD should be absorbed on paper towels is unnecessary, as
the BD will evaporate too quickly.
Appendix B, Parts VI (C) and (D): Sanitation requirements
concerning agents to remove BD from the skin, and separate lockers, are
unnecessary, since liquid BD evaporates rapidly and will not
contaminate skin or clothing for any significant time.
Not also the odor threshold discrepancy between Appendix B, Part
II(C) and Appendix D, Part 1.1.4. The correct value is 0.45 ppm, based
on the AIHA publication, ``Odor Thresholds for Chemicals with
Established Occupational Health Standards,'' (1989).
OSHA believes the agreement contains a number of provisions that
will greatly improve worker health and therefore should be included in
the final BD standard. However, prior to inclusion, the Agency must be
certain of the meaning and effect of the provisions and then translate
the recommendations into regulatory language. To this end, OSHA seeks
comment on the following issues addressed by labor and industry in
their agreement:
1. Definitions. When objective data are relied upon to exclude
products with a BD concentration of 0.1% or less, what should be the
source of the objective data? Should conditions be placed upon the
monitoring or modeling methods used to obtain or project exposure
levels in order to ensure accuracy?
2. Exposure Monitoring. OSHA is concerned that the taking of 8
samples to establish a baseline may not be an effective use of scarce
industrial hygiene resources in that the number of samples taken may be
far less important than the quality of the samples used to characterize
the exposure of BD employees. Are there other ways to improve OSHA's
traditional approach of monitoring at least the one most exposed
employee in each job classification on each shift? Please comment.
3. Exposure Goal Program. OHSA requests comment on whether the
requirements for specific engineering controls rather than a
performance approach could lead to situations in which (1) better
engineering controls are discouraged or ignored, (2) the required
controls may not be applicable, or (3) the required controls may not be
needed because work practices will achieve the necessary reduction. How
could these situations be avoided?
4. Respirators. ANSI does not have final protocols for respirator
fit-testing. OSHA is in the process of completing its generic
respirator standard that will include protocols for fit-testing. (OSHA
Docket No. H-049; 59 FR 5884, November 15, 1994). Do workers exposed to
BD need special provisions for respirator fit-testing? If so, what
provisions are necessary and why? What applications are appropriate for
half-mask negative pressure respirators? Should the standard specify
tasks or exposures where the respirators are or are not appropriate?
5. Medical Surveillance. OSHA is concerned that some at-risk
employees
[[Page 9383]]
will not be afforded the protection of medical surveillance because
eligibility for inclusion requires exposures of 60 days above the AL or
30 days above the PEL, requirements that are more restrictive than the
comparable requirements in OSHA standards for acrylonitrile, (any
exposure above the AL); benzene, (30 days above AL or 10 above PELs);
and cadmium, (30 days above AL). OSHA also seeks comment on whether the
medical requirements in the respirator standard for general industry,
29 CFR 1910.134(b)(10), may be inadequate to protect workers with
occupational exposure to BD. In addition, should each employee whose
exposure to BD requires the use of a respirator be included in the
medical surveillance program, regardless of duration of exposure?
Finally, by requiring employees whose former exposures were above the
action level for 60 days or the PEL for 30 days to have had 10 years of
exposure before being included in medical surveillance, would the
standard improperly exclude employees whose exposures occurred over a
lesser period of time, say 5 years, but whose risk may be comparable?
6. Communication of BD Exposure to Employees. OSHA is concerned
that eliminating the reference to potential reproductive hazard from
warning signs and labels would not provide sufficient information to
employees. Toxicological studies cited in the proposal indicate BD is a
potential reproductive hazard. For example, ovarian atrophy and
testicular atrophy were observed in mice exposed to BD. OSHA is
considering requiring the warning signs and labels to contain the
phrase ``Cancer and Potential Reproductive Hazard.''
C. Additional Issues
OSHA is also seeking comment on the following issues that were
neither addressed by labor and industry in their agreement, nor fully
aired at the rulemaking hearing:
1. OSHA proposed to define ``Emergency'' as:
* * * any occurrence such as, but not limited to, equipment
failure, rupture of containers, or failure of control equipment that
may or does result in an unexpected significant release of BD.
OSHA is considering limiting the emergency releases to those that are
uncontrolled, so that the last phrase of the definition would read: ``*
* * that may or does result in an uncontrolled significant release of
BD.'' Does this addition clarify what situations OSHA considers to be
emergencies? Does the term ``significant release'' give adequate
guidance to employers as to how much BD must be released in order to
constitute an emergency?
2. OSHA is considering the adequacy of a less burdensome medical
surveillance program for BD-exposed workers. The program would consist
of an initial medical examination, repeated every third year, and an
annual CBC along with a yearly questionnaire focusing on the
hematopoietic and reproductive systems. OSHA requests comment on
whether this approach is sufficiently protective. OSHA is also seeking
comment on whether medical removal protection provisions similar to
those contained in the Benzene Standard (29 CFR 1910.1028) are
appropriate for BD. Removal would be predicated upon a medical
determination that the employee should not continue to be exposed to
BD.
3. Where employers rely on objective data to exempt them from
monitoring responsibilities, OSHA is considering requiring these
employers to keep the data for as long as such data continue to be
relied upon. Is this the appropriate length of time to keep such data?
D. Additional Submissions to the BD Docket
OSHA is submitting the following reports to the BD Docket:
(1) Abstracts from International Symposium: Evaluation of Butadiene
and Isoprene Health Risks, June 27-29, 1995, Blaine, Washington; (2)
Delzell, E., N. Sathiakumar, M. Macaluso, M. Hovinga, R. Larson, F.
Barbone, C. Beall, P. Cole, A Follow-up Study of Synthetic Rubber
Workers, October 2, 1995; (3) Santos-Burgua, C., G. Matanoski, S.
Zeger, L. Schwartz, ``Lymphohematopoietic Cancer in Styrene-Butadiene
Polymerization Workers,'' American Journal of Epidemiology, Volume 136,
1992, pp. 843-844; and (4) M. Sorsa, K. Peltonen, H. Vainio, and K.
Hemminki (eds.), Butadiene and Styrene Assessment of Health Hazards,
International Agency for Research on Cancer Scientific Publication No.
127, Lyon, France, 1993.
II. Public Participation
Comments
Written comments regarding the issues raised by this notice must be
postmarked by April 8, 1996. Four copies of these comments must be
submitted to the Docket Office, Docket No. HS-041), U.S. Department of
Labor, 200 Constitution Avenue, NW, Washington, DC 20210. Written
comments limited to 10 pages or less in length may also be transmitted
by facsimile to (202) 219-5046, provided the original and 3 copies are
sent to the Docket Office thereafter. All materials submitted will be
available for inspection and copying at the above address. Materials
previously submitted to the Docket for this rulemaking need not be re-
submitted.
III. Authority
This document was prepared under the direction of Joseph A. Dear,
Assistant Secretary of Labor for Occupational Safety and Health, U.S.
Department of Labor, 200 Constitution Avenue, NW, Washington, D.C.
20210. It is issued pursuant to section 6(b) of the Occupational Safety
and Health Act (29 U.S.C. 655), and 29 CFR part 1911.
Signed at Washington, D.C., this 5th day of March, 1996.
Joseph A. Dear,
Assistant Secretary of Labor.
[FR Doc. 96-5519 Filed 3-7-96; 8:45 am]
BILLING CODE 4510-26-M
Complete official Federal Register PDF
FR Doc. 96-5515 Disclosure, Publication, and Notice of Change of Rates and Other Service Terms for Rail Common Carriage
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9413-9415]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5515]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
49 CFR Chapter X
[STB Ex Parte No. 528]
Disclosure, Publication, and Notice of Change of Rates and Other
Service Terms for Rail Common Carriage
AGENCY: Surface Transportation Board, DOT.
ACTION: Advance Notice Of Proposed Rulemaking.
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SUMMARY: The ICC Termination Act of 1995 (ICCTA) eliminated the tariff
and tariff filing requirements formerly applicable to rail carriers,
but imposed in lieu thereof certain obligations to disclose common
carriage rates and service terms as well as a requirement
[[Page 9414]]
for advance notice of an increase in such rates or change in service
terms. The ICCTA requires the Board to promulgate regulations to
administer these new obligations by June 29, 1996. The Board seeks
public comment on appropriate regulations for that purpose, and
encourages the affected interest groups to discuss and seek mutually
agreeable regulations to propose.
DATES: Comments are due on April 8, 1996.
ADDRESSES: Send comments (an original and 10 copies) referring to STB
Ex Parte No. 528 to: Surface Transportation Board, Office of the
Secretary, Case Control Branch, 1201 Constitution Avenue NW.,
Washington, DC 20423.
FOR FURTHER INFORMATION CONTACT: Beryl Gordon, (202) 927-5610. [TDD for
the hearing impaired: (202) 927-5721.]
SUPPLEMENTARY INFORMATION: The ICC Termination Act of 1995, Pub. L. No.
104-88, 109 Stat. 803 (ICCTA), enacted on December 29, 1995, abolished
the Interstate Commerce Commission (ICC) and transferred responsibility
for the economic regulation of rail transportation to a new Surface
Transportation Board (the Board). See ICCTA Section 101 (abolition of
the ICC). See also new 49 U.S.C. 701(a) (establishment of the Board),
as enacted by ICCTA Section 201(a). The transfer took effect on January
1, 1996. See ICCTA Section 2 (effective date).1
\1\ The ICCTA also made several changes to the rail regulatory
authority that had been administered by the ICC. In this notice,
when referring to the provisions of the United States Code affected
by ICCTA we use the word former to refer to the law in effect prior
to January 1, 1996, and the word new to refer to the law in effect
on and after January 1, 1996.
---------------------------------------------------------------------------
The substantive provisions of the new law differ in several
important respects from the former law. As pertinent here, the former
law required that rail carriers file with the ICC tariffs containing
the specific rates and charges (or the basis for calculating them) for
their common carriage transportation services. Rail carriers had to
adhere to the rates and terms contained in their tariffs. See former 49
U.S.C. 10761 and 10762. See also 49 CFR part 1314 (1995).
The ICCTA eliminated the rail tariff requirements, effective
January 1, 1996. Accordingly, no new rail carrier tariffs are to be
filed with the Board, and the rail carrier tariffs that were previously
filed with the ICC are no longer effective tariffs as of January 1,
1996. The ICC regulations at 49 CFR part 1314, governing rail carrier
tariffs, are likewise not effective as of that date and are being
formally repealed in another proceeding recently initiated by the
Board.
Nevertheless, new 49 U.S.C. 11101(b) and (d) require disclosure of
rail common carriage rates and service terms. New 49 U.S.C. 11101(c)
further requires that rail carriers, when providing common carriage,
not increase their rates or change their service terms without advance
notice. Finally, new 49 U.S.C. 11101(e) requires rail carriers to
adhere to the rates and service terms published or otherwise made
available under new 49 U.S.C. 11101(b)-(d).2
\2\ A central feature of both the old and new law is the
requirement that a rail carrier adhere to its established rates.
Therefore, as a transition matter, a question that arises is whether
a rail carrier must continue to adhere to its established rates and
service terms--those that were in effect (in tariffs on file with
the ICC) on December 31, 1995--unless and until changed in a manner
consistent with the requirements of new section 11101. Otherwise, it
could be argued that there could be a break in the continuity of
rates that Congress did not intend.
---------------------------------------------------------------------------
New 49 U.S.C. 11101(f) directs the Board to establish rules to
implement the requirements of new 49 U.S.C. 11101. In accordance with
this directive, we intend to promulgate new regulations to implement
the requirements of new 49 U.S.C. 11101(b), (c), and (d). We do not
believe that implementing rules are required for new 49 U.S.C.
11101(a), which simply reenacts the longstanding common carrier
obligation that the carrier provide transportation or service on
reasonable request. We believe that this obligation, which has been
well developed through case law, is best addressed on a case-by-case
basis.
Similarly, our preliminary view is that implementing rules are not
required for new 49 U.S.C. 11101(e), which requires a rail carrier to
provide transportation or service in accordance with the rates and
service terms, and any changes thereto, as published or otherwise made
available under new 49 U.S.C. 11101(b), (c), or (d). This requirement
appears to be clear on its face.
The regulations implementing new section 11101 would appear to
apply to any transportation or service provided by a rail carrier
subject to our jurisdiction under new 49 U.S.C. 10501, with two
exceptions. They would not apply, it would seem, to transportation or
service provided by a rail carrier (1) under a contract pursuant to
former 49 U.S.C. 10713 or new 49 U.S.C. 10709, or (2) covered by an
exemption issued under former 49 U.S.C. 10505 or new 49 U.S.C. 10502,
to the extent that such exemption remains in effect and applies to rate
notice and disclosure requirements.
The new regulations would first need to address the requirement of
new 49 U.S.C. 11101(b) that a rail carrier promptly provide to any
person, on request, its rates and other service terms. It would appear
that this requirement applies both to the disclosure of an existing
rate (and related service terms) and to the establishment of a new rate
(and related service terms) where none exists.
In the situation where the carrier has existing rates covered by
the rate information request, the provisions of 49 U.S.C. 11101(b) and
(f) require the carrier ``immediate[ly]'' to disclose its ``rates and
service terms, including classifications, rules, and practices'' to any
person requesting such information. We seek suggestions for a rule that
would implement these provisions in a way that would provide the rate
requester with complete information about all relevant terms and
conditions. We also seek input on whether we should attempt to define
the word immediately, or instead should simply establish general
guidelines to be applied on a case-by-case basis, setting up broad
parameters governing disclosure.
There may be instances in which a shipper or prospective shipper
requests the carrier to establish a rate for a type of traffic for
which no existing rate is in place. Again, the provisions of 49 U.S.C.
11101(b) appear to require that the rail carrier provide a rate, as
well as any related charges and service terms, promptly. We seek input
on whether we ought to define the word promptly, or instead should
simply adopt broadly applicable guidelines.
The new regulations also need to address the requirement of new 49
U.S.C. 11101(c) that a rail carrier may not increase a common carriage
rate or change a common carriage service term without first giving 20
days' notice to any person who, within the previous 12 months, (1) has
requested that rate or term under new subsection (b), or (2) has made
arrangements with the carrier for a shipment that would be subject to
the increased rate or changed term. It seems to us that the advance
notice requirement would apply to known users of the transportation or
service to which the increase or change is applicable (i.e., a person
who has made a shipment within the past year or has already made
arrangements for a future shipment) and also to known prospective users
of such transportation or service (i.e., a person who has requested
that rate to be established). Our preliminary view is that it would not
be necessary or appropriate to require a carrier to keep a record of
and notify all persons who have requested rate information but are not
users of the
[[Page 9415]]
affected transportation service. We request comment on what guidance,
if any, should be given for determining which members of the shipping
public are covered by the 20-day notice period.
We note that the notice requirement does not apply to a rate
decrease, which a carrier may apply without notice. Similarly, it would
not seem that the notice requirement should apply to, and hence delay,
a change in service terms that is clearly beneficial to shippers. Our
initial view is that it is not necessary to establish rules addressing
how to determine whether a service change is clearly beneficial to
shippers. Commenters may wish to address this issue.
The new regulations also need to address the publication
requirement of new 49 U.S.C. 11101(d), which requires railroads to
``publish, make available, and retain for public inspection [their]
common carrier rates, schedule of rates, and other service terms,'' and
any changes thereto, for the transportation of agricultural products
(including grain, as defined in 7 U.S.C. 75, and all products thereof)
and fertilizer. It should be noted that the publication requirement for
these commodities is in addition to the disclosure and notification
requirements of new subsections (b) and (c). This additional
requirement reflects Congress' concern that broad dissemination of
market information on a timely basis is particularly critical to the
agricultural sector of the economy, given the seasonal nature of its
transportation needs and the short time frame within which such needs
must be met.
It would seem that the required publication could be provided by
the rail carrier itself or by an agent (e.g., a publishing service or
another rail carrier) acting at the rail carrier's direction. It would
also seem that these publications would need to be made available to
all interested persons, but that the rail carrier or its agent should
be able to impose reasonable charges for such publications.3 We
seek comment on how best to implement this provision. Again, we request
input on how to interpret the requirement that publication of any
proposed or actual changes be made promptly.
\3\ Of course, to accommodate particular segments of the
agricultural sector, it would seem that carriers could, at their
discretion, continue to issue more narrowly focused publications as
well.
---------------------------------------------------------------------------
Finally, the new regulations should provide for the required
information to be supplied either in writing or in electronic form. It
would appear that the form chosen would depend upon the technical
capacities of the carrier to transmit, and of the requester to receive,
the information.
Request for Comments
We invite all interested persons to comment and to offer
suggestions for the new regulations. We encourage affected interest
groups to discuss these new requirements with each other and to seek a
mutually agreeable set of regulations that would meet the needs of all
affected interests--both shipper and carrier, and both large and small.
Comments (an original and 10 copies) must be in writing, and are
due on April 8, 1996.
We encourage any commenter that has the necessary technical
wherewithal to submit its comments as computer data on a 3.5-inch
floppy diskette formatted for WordPerfect 5.1, or formatted so that it
can be readily converted into WordPerfect 5.1. Any such diskette
submission (one diskette will be sufficient) should be in addition to
the written submission (an original and 10 copies).
Small Entities
Because this is not a notice of proposed rulemaking within the
meaning of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), we
need not conduct at this point an examination of impacts on small
entities. We will certainly welcome, of course, any comments respecting
whether regulations that commenters may suggest would have significant
economic effects on any substantial number of small entities.
Environment
The issuance of this advance notice of proposed rulemaking will not
significantly affect either the quality of the human environment or the
conservation of energy resources. Furthermore, we would not expect that
regulations suggested for implementing new 49 U.S.C. 11101 would
significantly affect either the quality of the human environment or the
conservation of energy resources. We certainly welcome, of course, any
comments respecting whether suggested revisions would have any such
effects.
Authority: 49 U.S.C. 721(a) and 11101.
Decided: February 29, 1996.
By the Board, Chairman Morgan, Vice Chairman Simmons, and
Commissioner Owen.
Vernon A. Williams,
Secretary.
[FR Doc. 96-5515 Filed 3-7-96; 8:45 am]
BILLING CODE 4915-00-P
Complete official Federal Register PDF
FR Doc. 96-5513 Revisions of Tariff RegulationsIndexes
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9419-9420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5513]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Surface Transportation Board
49 CFR Part 1312
[Ex Parte No. MC-211]
Revisions of Tariff Regulations--Indexes
AGENCY: Surface Transportation Board (Board).1
\1\ The ICC Termination Act of 1995, Pub. L. No. 104-88, 109
Stat. 803 (ICCTA), which was enacted on December 29, 1995, and took
effect on January 1, 1996, abolished the Interstate Commerce
Commission (ICC) and transferred certain functions and proceedings
to the Board. Section 204(b)(1) of the Act provides, in general,
that proceedings pending before the ICC on the effective date of
that legislation shall be decided under the law in effect prior to
January 1, 1996, insofar as they involve functions retained by the
Act. Although the motor carrier tariff filing provisions were
sharply curtailed in the ICCTA and in prior legislation, they were
not entirely repealed. Therefore, this pending proceeding is not
being terminated pursuant to the provisions of section 204(b)(3) of
the ICCTA, which calls for termination of cases that involve
functions eliminated by the ICCTA. Rather, as a proceeding that was
pending with the ICC prior to January 1, 1996, it is governed by the
law in effect prior to January 1, 1996.
---------------------------------------------------------------------------
ACTION: Withdrawal of Proposed Rule.
-----------------------------------------------------------------------
SUMMARY: The Board is withdrawing a proposed rule regarding the
indexing of tariffs because intervening legislation has made the rule
unnecessary.
DATES: The withdrawal is made on March 8, 1996.
FOR FURTHER INFORMATION CONTACT: Michael L. Martin, (202) 927-6033;
[TDD for the hearing impaired: (202) 927-5721.]
SUPPLEMENTARY INFORMATION: In a Notice of Proposed Rulemaking published
at 58 FR 42277 (August 9, 1993), the ICC proposed a rule to require
tariffs to contain indexes, unless the information in the tariff is
arranged in a pattern readily discernible to tariff users. The
proceeding was initiated in part in response to a directive contained
in a Senate report,2 and in part in recognition of the burdens
associated with using tariffs that could contain well over 100,000
unindexed pages.
\2\ Senate Report No. 102-351, dated July 30, 1992, accompanying
the U.S. Department of Transportation and Related Agencies
Appropriations Bill, 1993.
---------------------------------------------------------------------------
Most, if not all, of the large, unindexed tariffs were discount
tariffs that were filed by individual motor common carriers. However,
the Trucking Industry Regulatory Reform
[[Page 9420]]
Act of 1994 3 repealed the tariff filing requirement for
individually (as distinguished from collectively) set rates of motor
common carriers of property (other than household goods and carriers
involved with water carriers in the noncontiguous domestic trade), and
voided such tariffs. Because the tariffs that precipitated the proposal
---------------------------------------------------------------------------
for indexing are no longer filed, we are terminating this proceeding.
\3\ Pub. L. 103-311, 108 Stat. 1683, enacted August 26, 1994.
---------------------------------------------------------------------------
Authority: 49 U.S.C. 10321.
Decided: February 23, 1996.
By the Board, Chairman Morgan, Vice Chairman Simmons, and
Commissioner Owen.
Vernon A. Williams,
Secretary.
[FR Doc. 96-5513 Filed 3-7-96; 8:45 am]
BILLING CODE 4915-00-P
Complete official Federal Register PDF
FR Doc. 96-5511 Medicaid Program; Coverage of Personal Care Services
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9405-9410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5511]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Part 440
[MB-071-P]
RIN 0938-AG36
Medicaid Program; Coverage of Personal Care Services
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: In accordance with the provisions of section 13601(a)(5) of
the Omnibus Budget Reconciliation Act of 1993, which added section
1905(a)(24) to the Social Security Act, this proposed rule would
specify the revised requirements for Medicaid coverage of personal care
services furnished in a home or other location as an optional benefit,
effective for services furnished on or after October 1, 1994. In
particular, this proposed rule would specify that personal care
services may be furnished in a home or other location by any individual
who is qualified to do so. Additionally, we are proposing two minor
changes to the Medicaid regulations concerning home health services.
DATES: Comments will be considered if we receive them at the
appropriate address, as provided below, no later than 5 p.m. on May 7,
1996.
ADDRESSES: Mail written comments (one original and three copies) to the
following address: Health Care Financing Administration, Department of
Health and Human Services, Attention: MB-071-P, P.O. Box 7517-0517,
Baltimore, MD 21207.
If you prefer, you may deliver your written comments (one original
and three copies) to one of the following addresses: Room 309-G, Hubert
H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC
20201, or Room No. C5-11-17, 7500 Security Boulevard, Baltimore, MD
21244-1850.
Because of staffing and resource limitations, we cannot accept
comments by facsimile (FAX) transmission. In commenting, please refer
to file code MB-071-P. Comments received timely will be available for
public inspection as they are received, generally beginning
approximately 3 weeks after publication of a document, in Room 309-G of
the Department's offices at 200 Independence Avenue SW., Washington,
DC, on Monday through Friday of each week from 8:30 a.m. to 5 p.m.
(phone: (202) 690-7890).
FOR FURTHER INFORMATION CONTACT: Terese Klitenic (410) 786-5942.
SUPPLEMENTARY INFORMATION:
I. Background
Title XIX of the Social Security Act (the Act) authorizes grants to
States for medical assistance (Medicaid) to certain individuals whose
income and resources are insufficient to meet the cost of necessary
medical care. The Medicaid program is jointly financed by the Federal
and State governments and administered by the States. Within Federal
rules, each State chooses eligible groups, types and ranges of
services, payment levels for most services, and administrative and
operating procedures. The nature and scope of a State's Medicaid
program is described in the State plan that the State submits to HCFA
for approval. The plan is amended whenever necessary to reflect changes
in Federal or State law, changes in policy, or court decisions.
Under section 1902(a)(10) of the Act, States must provide certain
basic services. Section 1905(a) of the Act defines the services States
may provide as medical assistance. Personal care services historically
have been permitted under the Secretary's discretionary authority under
current section 1905(a)(25) of the Act until the enactment of
legislation, described below. Currently, regulations concerning
personal care services are located at 42 CFR 440.170(f).
II. Legislation Concerning Personal Care Services
Before the enactment of the legislation discussed below, a State
had the option to elect to cover personal care services under its
Medicaid State plan. Although not specifically mentioned in section
1905(a) of the Act, personal care services could be covered under
section 1905(a)(22) of the Act (redesignated as section 1905(a)(25) of
the Act on November 5, 1990), under which a State may furnish any
additional services specified by the Secretary and recognized under
State law. In Sec. 440.170(f), the Secretary specified that personal
care services may be covered.
Section 4721 of the Omnibus Budget Reconciliation Act of 1990 (OBRA
'90) (Pub. L. 101-508, enacted on November 5, 1990) amended section
1905(a)(7) of the Act to include personal care services as part of the
home health services benefit and to impose certain conditions on the
provision of personal care services, effective for services furnished
on or after October 1, 1994. This amendment would have had a
significant effect since, under section 1902(a)(10)(D) of the Act, home
health services are a mandatory benefit for all Medicaid recipients
eligible for nursing facility services under the State plan. Thus, had
section 1905(a)(7) of the Act not been further amended (as discussed
below) before the effective date of section 4721 of OBRA '90, personal
care services would have become a mandatory benefit for all recipients
eligible for nursing facility services, effective October 1, 1994.
Before the provisions of OBRA '90 became effective, the Omnibus
Budget Reconciliation Act of 1993 (OBRA '93) (Pub. L. 103-66) was
enacted on August 10, 1993. Section 13601(a)(1) of OBRA '93 amended
section 1905(a)(7) of the Act to remove personal care services from the
definition of home health services. Additionally, section 13601(a)(5)
of OBRA '93 added a new paragraph (24) to section 1905(a) of the Act,
to include payment for personal care services under the definition of
medical assistance. Under section 1905(a)(24) of the Act, personal care
services furnished to an individual who is not an inpatient or resident
of a hospital, nursing facility, intermediate care facility for the
mentally retarded, or institution for mental disease is an optional
benefit for which States may provide medical assistance payments.
[[Page 9406]]
The statute specifies that personal care services must be: (1)
Authorized for an individual by a physician in accordance with a plan
of treatment or (at the option of the State) otherwise authorized for
the individual in accordance with a service plan approved by the State;
(2) provided by an individual who is qualified to provide such services
and who is not a member of the individual's family; and (3) furnished
in a home or other location. This amendment is effective October 1,
1994. Therefore, as a result of the legislative changes made by OBRA
'93, personal care services continue to be an optional State plan
benefit, and are now authorized under section 1905(a)(24) of the Act,
effective for services furnished on or after October 1, 1994.
III. Provisions of the Proposed Regulations
A. Personal Care Services in a Home or Other Location (Sec. 440.167)
As historically used in the Medicaid program, personal care
services means services related to a patient's physical requirements,
such as assistance with eating, bathing, dressing, personal hygiene,
activities of daily living, bladder and bowel requirements, and taking
medications. These services primarily involve ``hands on'' assistance
by a personal care attendant with a recipient's physical dependency
needs (as opposed to purely housekeeping services). These tasks are
similar to those that would normally be performed by a nurse's aide if
the recipient were in a hospital or nursing facility. Although personal
care services may be similar to or overlap some services furnished by
home health aides, skilled services that may be performed only by a
health professional are not considered personal care services.
Alternatively, services that require a lower level of skill such as
personal care services may also be provided by home health aides in the
home under the home health benefit.
The above description of personal care services is based on the
definition of personal care services originally set forth in Part 5,
Section 140, of the Medical Assistance Manual (the precursor of the
State Medicaid Manual) and reflects States' experiences in providing
these services. We plan to publish a definition of personal care
services in the State Medicaid Manual in the near future. Until that
time, States should use the above description of personal care services
as a guide in setting parameters for this optional benefit. To provide
States with maximum flexibility in providing personal care services, we
are providing guidelines for this benefit in a manual issuance, rather
than codifying it in the regulations.
Currently, provisions regarding personal care services in a
recipient's home are set forth at Sec. 440.170. This section of the
regulations defines the additional services that States may furnish as
any other medical care or remedial care recognized under State law and
specified by the Secretary. Under Sec. 440.170(f), personal care
services in a recipient's home means services prescribed by a physician
in accordance with the recipient's plan of treatment, and furnished by
an individual who is (1) qualified to provide the services, (2)
supervised by a registered nurse, and (3) not a member of the
recipient's family. The existing regulations do not provide for
personal care services furnished in settings other than the recipient's
home.
To conform the regulations to the provisions of section 1905(a)(24)
of the Act (as added by section 13601(a)(5) of OBRA '93), we propose to
add a new Sec. 440.167, ``Personal care services in a home or other
location.'' We would specify that personal care services are services
furnished to an individual who is not an inpatient or resident of a
hospital, nursing facility, intermediate care facility for the mentally
retarded, or institution for mental disease, that are: (1) authorized
for the individual by a physician in accordance with a plan of
treatment or (at the option of the State) otherwise authorized for the
individual in accordance with a service plan approved by the State; (2)
provided by an individual who is qualified to provide such services and
who is not a member of the individual's family; and (3) furnished in a
home, and if the State chooses, in another location.
Since section 1905(a)(24) of the Act does not require that the
services be supervised by a registered nurse, we would not require such
supervision in proposed Sec. 440.167. While section 13601(a)(1) of OBRA
'93 eliminated the statutory requirement for supervision by a
registered nurse, the versions of the bill passed by both the House and
Senate (H.R. 2264) contained this requirement. The nurse supervision
requirement was apparently dropped while the bill was in conference;
however, the conference report does not specifically refer to this
change (H. Conf. Rept. No. 2133, 103rd Cong., 1st sess., page 833,
(1993)). We believe our proposal reflects statutory intent to eliminate
the requirement for such supervision. Moreover, since extensive medical
knowledge or technical skill is not required to provide personal care
services, we believe that supervision by a registered nurse is not
necessary in most cases. However, we are soliciting public comments
concerning the need to retain the requirement that personal care
services be provided under the supervision of a registered nurse or
another supervisory individual, such as a medical social worker.
Under our proposal, States that elect to offer the personal care
services benefit must cover personal care services provided in the home
but may also choose to cover personal care services provided in other
locations. We believe that this proposal is consistent with the intent
of the statute to expand the possible settings where personal care
services may be covered under the Medicaid program. We note that
coverage of personal care services outside the home is not optional
with respect to those individuals who require personal care services
that are medically necessary to correct or ameliorate conditions
discovered as a result of a screen performed under the Early and
Periodic Screening, Diagnostic, and Treatment (EPSDT) program.
We also considered two other options for implementing the provision
of OBRA '93 that allows States to cover personal care services
furnished outside the home. One option was to require States that elect
to offer the personal care services benefit to cover such services in
both the home and other locations. However, section 1905(a)(24)(C) of
the Act refers to services ``furnished in a home or other location,''
and we believe that this option would unnecessarily limit States'
flexibility in implementing the personal care services benefit.
Moreover, it could work against the best interests of recipients if
States choose not to offer the personal care services benefit at all
because of the expense involved in covering the services both inside
and outside the home.
We also considered allowing States electing to offer this benefit
to cover the services either in the home or in other locations. Since
many States historically have covered these services when furnished in
the recipient's home, we do not believe that it would be consistent
with statutory intent to allow States to choose to cover personal care
services only in locations other than the home. That is, States that
have previously covered personal care services furnished in the home
should not be allowed to eliminate this location and opt to cover the
services only when provided outside of the home. Again, we believe that
the purpose of section 1905(a)(24) of the Act is to add to the possible
settings where
[[Page 9407]]
States may provide personal care services, not to decrease the amount
of services currently being offered. Thus, we believe that our proposed
policy is the most appropriate interpretation of the statute, is in the
best interest of recipients, and gives States the discretion necessary
to operate their programs in an efficient manner.
We propose to leave to the State's option the decision of whether
personal care services are to be authorized by a physician in
accordance with a plan of treatment, or otherwise authorized in
accordance with a service plan approved by the State. Similarly, we
would permit States to determine, through development of provider
qualifications, which individuals are qualified to provide personal
care services (other than family members). Again, we believe that these
proposed provisions would allow States to maintain a high level of
flexibility in providing and defining optional personal care services.
We note that home health aides employed by home health agencies may
sometimes provide personal care services. Home health aides that
provide only personal care services under Medicaid need only meet the
qualifications set forth at Sec. 484.36(e) (and not the other
qualifications for home health aide services).
Section 1905(a)(24)(B) of the Act specifies that, for Medicaid
purposes, personal care services may not be furnished by a member of
the individual's family. To date, we have not defined ``family member''
for purposes of the personal care services benefit. Thus, each State
that offers this benefit makes its own determination as to who is
considered a family member for purposes of personal care services. To
provide for more clarity and consistency in this regard, we propose to
define family members under new Sec. 440.167(b) as spouses of
recipients and parents (or step-parents) of minor recipients. This
definition is essentially identical to the one that applies to personal
care services provided under a home and community-based waiver (see
section 4442.3.B.1. of the State Medicaid Manual). We believe that
spouses and parents are inherently responsible for meeting the personal
care needs of their family members, and, therefore, it would not be
appropriate to allow Medicaid reimbursement for such services. States
would continue to have the flexibility to expand upon the definition of
family members at Sec. 440.167. That is, States could further restrict
which family members can qualify as providers by extending the
definition to apply to family members other than spouses and parents.
We note that our proposed definition of family member would only
apply for purposes of the personal care services benefit in
Sec. 440.167 and not for other Medicaid benefits that allow
reimbursement for family members. Because we recognize that States have
developed their own definitions of ``family members'' for purposes of
the personal care services benefit, we welcome comments on our proposed
definition.
Since personal care services are now an optional benefit under
section 1905(a)(24) of the Act, we would remove current
Sec. 440.170(f), which provides for coverage of personal care services
in a recipient's home as part of any other medical care or remedial
care recognized under State law and specified by the Secretary.
B. Proposed Changes Concerning Home Health Services (Sec. 440.70)
We are proposing several changes to the regulations concerning home
health services. Currently, Sec. 440.70(a)(2) provides that home health
services must be furnished to a recipient on his or her physician's
orders as part of a written plan of care that the physician reviews
every 60 days. Section 440.70(b) lists the services that constitute
home health services and thus are subject to the plan of care
requirements. Section 440.70(b)(3) specifies that these services
include medical supplies, equipment, and appliances suitable for use in
the home. We have found that in many cases, once a recipient's need for
medical supplies, equipment, and appliances is indicated by a
physician, that need is unlikely to change within 60 days. Thus, absent
changes in a recipient's condition, we do not believe that a
recipient's need for medical equipment necessitates routine inclusion
in a plan of care reviewed every 60 days by a physician.
Modification of the plan of care and physician review requirements
for medical equipment would decrease physicians' paperwork burden as
well as the time and costs involved with these requirements.
Accordingly, we would revise Sec. 440.70(b)(3) to provide that
physician review of a recipient's need for medical supplies, equipment,
and appliances suitable for use in the home under the home health
benefit would be required annually. We believe that the requirement for
annual review of medical supplies and equipment would allow States
flexibility in furnishing home health services while providing an
appropriate level of oversight. Frequency of further review of a
recipient's continuing need for the equipment on other than an annual
basis would be determined on a case-by-case basis depending on the
nature of the item prescribed. A recipient's need for supplies or
pieces of equipment that generally tend to be used on a long-term basis
would not be reviewed as frequently as equipment that is usually used
only temporarily. For example, review of the need for a wheelchair need
not be as frequent as review of the need for an oxygen concentrator. In
all cases, a physician's order for the equipment would be required
initially.
Additionally, Sec. 440.70(d) now defines a home health agency for
purposes of Medicaid reimbursement as a public or private agency or
organization, or part of an agency or organization, that meets
requirements for participation in Medicare. We propose to revise this
definition to indicate that in order to participate in Medicaid, the
agency must meet Medicare requirements for participation as well as any
additional standards the State may wish to apply that are not in
conflict with Federal requirements. This proposed change reflects the
long standing principle in the Medicaid program that affords States
flexibility in establishing Medicaid program requirements tailored to
their own specific needs. Under this proposal a State would have the
option of imposing additional standards on home health agencies for
participation in Medicaid beyond the Medicare conditions of
participation.
Finally, we are making a technical change to Sec. 440.70(c) to
remove an obsolete reference to subparts F and G of part 442.
IV. Impact Statement
A. Background
For proposed rules such as this, we generally prepare a regulatory
flexibility analysis that is consistent with the Regulatory Flexibility
Act (RFA) (5 U.S.C. 601 through 612), unless we certify that a proposed
rule will not have a significant economic impact on a substantial
number of small entities. For purposes of a RFA, States and individuals
are not considered small entities. However, providers are considered
small entities.
In addition, section 1102(b) of the Act requires us to prepare a
regulatory impact analysis for any proposed rule that may have a
significant impact on the operation of a substantial number of small
rural hospitals. Such an analysis must conform to the provisions of
section 604 of the RFA. For purposes of section 1102(b) of the Act, we
define a small rural hospital as a hospital that is located outside of
a Metropolitan
[[Page 9408]]
Statistical Area and has fewer than 50 beds.
We are not preparing a rural impact statement since we have
determined, and we certify, that this proposed rule would not have a
significant impact on the operations of a substantial number of small
rural hospitals.
In accordance with the provisions of section 1905(a)(24) of the
Act, this proposed regulation would revise the regulations to
incorporate the new statutory requirements concerning personal care
services. In accordance with the statute, we are proposing that the
services must be: (1) Authorized for the individual by a physician in
accordance with a plan of treatment or (at the option of the State)
otherwise authorized for the individual in accordance with a service
plan approved by the State; (2) provided by an individual who is
qualified to provide such services and who is not a member of the
individual's family; and (3) furnished in a home or other location.
In general, the provisions of this proposed rule are prescribed by
section 1905(a)(24) of the Act, as added by section 13601(a)(5) of OBRA
'93. The most significant change required under the statute is that, as
of October 1, 1994, the settings in which States may elect to cover
personal care services have been expanded to include locations outside
the home. We believe that this statutory provision will increase
Medicaid program expenditures independently of the promulgation of this
rule. The primary discretionary aspect of this rule is our proposal
that States electing to offer the personal care services benefit must
cover the services in the home and may choose to cover them in any
other location. As discussed in section III.A of this preamble, we
considered requiring States that elect to offer the personal care
services benefit to cover such services in both the home and other
locations. We also considered allowing States to cover the services
either in the home or in other locations. However, we believe that our
proposed policy is the most appropriate interpretation of the statute
and gives States the discretion necessary to operate their programs in
an efficient manner and in the best interest of their recipients.
As noted above, the major provisions of this proposed rule are
required by the statute. Thus, costs associated with these proposed
regulations are the result of legislation. However, to the extent that
a legislative provision being implemented through rulemaking may have a
significant effect on recipients or providers or may be viewed as
controversial, we believe that we should address any potential
concerns. In this instance, we believe it is desirable to inform the
public of our estimate of the substantial budgetary effect of these
statutory changes. The statutorily driven costs have been included in
the Medicaid budget baseline. In addition, we anticipate that a large
number of Medicaid recipients and providers, particularly home health
agencies, will be affected. Thus, the expansion of settings where
personal care services may be furnished represents an expansion of
Medicaid benefits that, if exercised by States, would likely have
significant effects, particularly on Medicaid recipients.
B. Impact of New Personal Care Services Provision
1. Overview
This analysis addresses a wide range of costs and benefits of this
rule. Whenever possible, we express impact quantitatively. In cases
where quantitative approaches are not feasible, we present our best
examination of determinable costs, benefits and associated issues.
It is difficult to predict the economic impact of expanding the
settings where personal care services may be covered under Medicaid to
locations outside the home. We do not know the exact number and type of
personal care services furnished by individual States or how much these
services currently cost. Currently, approximately 32 States offer
coverage for personal care services, and we do not have cost data from
all of those States. States also differ in their definitions of
personal care services and rules concerning who may furnish them. Since
we do not have a full picture of the scope or cost of the different
services, it is difficult for us to quantify the impact these changes
will have. Other unknown factors regarding the future provision of
personal care services include which States now offering the personal
care services benefit will choose to cover services furnished outside
the home, how many additional States will opt to offer coverage, how
many Medicaid recipients will elect to utilize these services in States
in which the services have not been covered, and the type and costs of
these specific services. We believe that the majority of those
individuals who qualify for these services will elect to utilize this
benefit. Thus, although costs to States will rise as they begin to pay
for the additional services, there would be substantial benefits to
some providers and to Medicaid recipients as described in detail below.
2. Effects Upon Medicaid Recipients
Permitting States that elect to offer the personal care services
benefit the option of covering these services in locations outside the
home will have a positive effect on recipients. In States where
coverage has been provided only for personal care services in the home,
this proposed rule may expand the types of personal care services
available and/or the settings where recipients may receive these
services. Expansion of personal care services or settings could help
improve the quality of life for these recipients as well as for
recipients who have not been receiving personal care services. It also
would save money for some Medicaid recipients or their families since
they would no longer have to pay for these services. No data are
available on the number of recipients or family members who are
currently paying for these services. However, since only 32 States
currently pay for personal care services, we believe that a substantial
number of recipients who receive these services are paying for them out
of pocket.
3. Effects on Providers
By expanding the range of settings in which Medicaid will cover
personal care services, we anticipate that this proposed rule will
increase the demand for such services. We believe this effect will be
viewed as beneficial to providers of personal care services. If the
increase in demand for such services is sufficient, the number of
providers of personal care services may increase.
4. Effects on Medicaid Program Expenditures
This proposed rule would implement the provisions of section
1905(a)(24) of the Act by specifying that personal care services are an
optional State plan benefit under the Medicaid program. The proposed
rule would allow States the option to cover personal care services
furnished in a home or other location, effective for services furnished
on or after October 1, 1994. Table 1 below provides an estimate of the
anticipated additional Medicaid program expenditures associated with
furnishing these services outside the home, beginning on October 1,
1994. This estimate was made using various assumptions about increases
in utilization by current recipients, adjusted for age, as well as
assumptions about the induced utilization that would result from the
availability of these services. We have assumed a utilization increase
of 5 percent for the aged and 10 percent for the non-aged, and an
overall induction factor of 10 percent. We have
[[Page 9409]]
also assumed that the option of providing personal care services
outside the home would affect only those States that represent 33
percent of Medicaid personal care spending. Given these assumptions,
our estimate based on Federal budget projections is shown in Table 1,
which also provides a breakdown of these costs. The first row of
figures shows the costs of providing this optional State plan benefit.
The second row shows the administrative costs associated with
furnishing these services. We estimate the following costs to the
Medicaid program:
Table 1.--Personal Care Services Outside the Home
----------------------------------------------------------------------------------------------------------------
Federal medicaid cost estimate (in millions)*
---------------------------------------------------
FY 1996 FY 1997 FY 1998 FY 1999
----------------------------------------------------------------------------------------------------------------
Services.................................................... $230 $280 $350 $430
Administration costs........................................ 10 10 15 15
Total................................................. $240 $290 $365 $445
----------------------------------------------------------------------------------------------------------------
*Figures are rounded to the nearest $5 million. We note that the costs associated with these proposed
regulations are the result of legislation and due to the interpretation of statutory changes already in
effect. Therefore, these costs have been included in the Medicaid budget estimates.
5. Effects on States
As stated above, the coverage of personal care services is optional
except when such services are medically necessary to correct or
ameliorate medical problems found as a result of a screen under the
EPSDT program. Many States currently do not cover optional personal
care services. In those States that do offer the personal care services
benefit, services furnished outside the home previously could not be
covered. Therefore, there may be a substantial economic impact on
States that decide to provide coverage for personal care services
furnished outside the home. The varying State definitions of personal
care services, and rules concerning who may furnish them, make it
difficult to estimate accurately the potential increases in
expenditures for those States that choose to expand coverage of
personal care services to include services furnished outside the home.
However, Table 2, which is based upon the same data and assumptions
used to formulate the Federal expenditures shown in Table 1, estimates
the cost to States.
Table 2.--Personal Care Services Outside the Home
----------------------------------------------------------------------------------------------------------------
State cost estimate (in millions)*
---------------------------------------------------
FY 1996 FY 1997 FY 1998 FY 1999
----------------------------------------------------------------------------------------------------------------
Services.................................................... $175 $210 $265 $325
Administration costs........................................ 5 10 10 10
---------------------------------------------------
Total................................................. 180 220 275 335
----------------------------------------------------------------------------------------------------------------
*Figures are rounded to the nearest $5 million.
C. Conclusion
The provisions of this proposed rule are required by section
1905(a)(24) of the Act. We believe that the provisions of this rule
adding personal care services as an optional State plan benefit and
expanding the possible settings for covering personal care services to
locations outside the home will benefit providers, recipients and their
families.
As shown above in Tables 1 and 2, the costs to the Federal
government and States associated with paying for personal care services
furnished outside the home are substantial. There may be some minor off
setting of costs if the number of admissions to nursing facilities
decreases as a result of these provisions, but we have no data to
determine the potential savings, if any. Regardless of any possible
savings, the economic impact of these provisions is attributable to the
statutory changes mandated by OBRA '93.
In accordance with the provisions of Executive Order 12866, this
proposed rule was reviewed by the Office of Management and Budget.
V. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
VI. Response to Comments
Because of the large number of items of correspondence we normally
receive on a proposed rule, we are not able to acknowledge or respond
to them individually. We will consider all comments we receive by the
date and time specified in the DATES section of this preamble, and, if
we proceed with a final rule, we will respond to the comments in the
preamble to that document.
List of Subjects in 42 CFR Part 440
Grant programs-health, Medicaid.
42 CFR part 440 is proposed to be amended as set forth below:
PART 440--SERVICES: GENERAL PROVISIONS
1. The authority citation for part 440 continues to read as
follows:
Authority: Sec. 1102 of the Social Security Act (42 U.S.C.
1302).
Subpart A--Definitions
2. In Sec. 440.70, the introductory text of paragraph (a) and the
first sentence of the introductory text of paragraph (b) are
republished and paragraphs (a)(2), (b)(3), (c) and (d) are revised to
read as follows:
Sec. 440.70 Home health services.
(a) ``Home health services'' means the services in paragraph (b) of
this section that are provided to a recipient--
* * * * *
(2) On his or her physician's orders as part of a written plan of
care that the physician reviews every 60 days, except
[[Page 9410]]
as specified in paragraphs (b)(3) (i) and (ii) of this section.
(b) Home health services include the following services and items.
* * *
* * * * *
(3) Medical supplies, equipment, and appliances suitable for use in
the home.
(i) A recipient's need for medical supplies, equipment, and
appliances must be reviewed by a physician annually.
(ii) Frequency of further physician review of a recipient's
continuing need for the items is determined on a case-by-case basis,
based on the nature of the item prescribed;
* * * * *
(c) A recipient's place of residence, for home health services,
does not include a hospital, nursing facility, or intermediate care
facility for persons with mental retardation.
(d) ``Home health agency'' means a public or private agency or
organization, or part of an agency or organization that meets
requirements for participation in Medicare and any additional standards
legally promulgated by the State that are not in conflict with Federal
requirements.
* * * * *
3. A new Sec. 440.167 is added to read as follows:
Sec. 440.167 Personal care services
(a) Personal care services means services that are furnished to an
individual who is not an inpatient or resident of a hospital, nursing
facility, intermediate care facility for persons with mental
retardation, or institution for mental disease that are--
(1) Authorized for the individual by a physician in accordance with
a plan of treatment or (at the option of the State) otherwise
authorized for the individual in accordance with a service plan
approved by the State;
(2) Provided by an individual who is qualified to provide such
services and who is not a member of the individual's family; and
(3) Furnished in a home, and at the State's option, in another
location.
(b) For purposes of this section, family member means a parent (or
step parent) of a minor recipient or a recipient's spouse.
4. In Sec. 440.170, paragraph (f) is removed and reserved.
(Catalog of Federal Domestic Assistance Program No. 93.778, Medical
Assistance Program)
Dated: October 6, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 96-5511 Filed 3-7-96; 8:45 am]
BILLING CODE 4120-01-P
Complete official Federal Register PDF
FR Doc. 96-5489 Risk-Based Alternative to the Pressure Testing Older Hazardous Liquid and Carbon Dioxide Pipelines
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9415-9419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5489]
-----------------------------------------------------------------------
DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Part 195
[Docket No. PS-144; Notice-1]
Risk-Based Alternative to the Pressure Testing Older Hazardous
Liquid and Carbon Dioxide Pipelines
AGENCY: Research and Special Programs Administration (RSPA), DOT.
ACTION: Notice of public meeting.
-----------------------------------------------------------------------
SUMMARY: The Research and Special Programs Administration (RSPA)
invites representatives of industry, state, and local government, and
the public to an open meeting to discuss a proposal by the American
Petroleum Institute (API) for a risk-based alternative to the pressure
testing older hazardous liquid and carbon dioxide pipelines rule (see
Attachment). The purpose of this meeting is to obtain public views
before RSPA considers API's proposal.
DATES: The meeting will be held on March 25, 1996, from 1:00 p.m. to
5:00 p.m. Written comments, in duplicate, are due by April 15, 1996.
ADDRESSES: Interested persons should submit written comments in
duplicate to Dockets Unit, room 8421, Research and Special Programs
Administration, U.S. Department of Transportation, 400 Seventh Street,
SW., Washington, DC 20590-0001.
The meeting will be held at the U.S. Department of Transportation,
Nassif Building, 400 Seventh Street, SW, room 9230-34, Washington, DC.
Non-federal employee visitors are admitted into DOT headquarters
building through the southwest entrance at Seventh and E Streets, SW.
FOR FURTHER INFORMATION CONTACT:
Mike Israni, (202) 366-4571, regarding the subject matter of this
document, or the Dockets Unit (202) 366-5046, for copies of this
notice, the attachment or other material referenced in this notice.
SUPPLEMENTARY INFORMATION: On June 7, 1994, RSPA issued a final rule
(59 FR 29379) requiring the hydrostatic pressure testing of certain
older hazardous liquid and carbon dioxide pipelines. On June 23, 1995,
API filed a petition on behalf of many liquid pipeline operators
expressing strong concerns about the pressure testing rule in its
present form and proposing a risk-based alternative to the pressure
testing rule. API argued that its proposal would allow operators to
focus resources for a greater reduction in the overall risk from
pipeline accidents. In addition, RSPA has received a few requests for
waivers of compliance with the June 7, 1994, final rule.
[[Page 9416]]
RSPA wants to carefully evaluate the API proposal because RSPA has
been working actively with the pipeline industry to develop a risk
management framework for pipeline regulations. RSPA realizes that
substantial planning is required before pressure testing of older
pipelines. Operators need time to prepare pipeline systems for testing
and to arrange for personnel and equipment to conduct the tests. System
changes and actual testing must be coordinated with operations to
minimize the impact on refineries, distributors, and users of the
transported products. Also, operators need time to assure that testing
is done safely, with the least environmental risk, and in accordance
with applicable Federal and State regulations. Therefore, RSPA issued a
notice (60 FR 54328; October 23, 1995) of an extension of the time for
compliance to allow for evaluation of the API petition.
On January 31, 1996, RSPA held a meeting with the representatives
of API to explore technical details of the API's proposal. Main
features of the API's risk-based proposal are as follows:
(a) Highest priority is given to the highest risk facilities;
lowest risk facilities are excepted;
(b) Consequence factors such as location, product type, and release
potential are taken into consideration when setting testing priorities;
(c) Best available technology is applied to verify pipeline
integrity; and
(d) Timing of tests is based on risk.
It is important to note that current rule does not require any
continuing effort to reassess the pipeline; however, under API's risk-
based alternative, the operator may be obliged to reassess the risk
classification on a continuing basis.
It should also be noted that in the API's risk-based proposal,
there may be many pipelines that would not be hydrostatically tested.
Those pipelines that pose the lowest risks would be excepted from
testing. API's proposal provides for an alternative to hydrostatic
testing in most cases where testing would be required. The alternative
would be internal inspection using ``smart pigs.''
RSPA is concerned that the risk classifications in API's proposal
do not specifically account for the probability of pipeline failures.
RSPA is suggesting that this could be remedied by including
consideration of the history of past failures for a particular pipeline
system in the API proposal. The following versions of API Tables have
been modified by RSPA to suggest such an approach.
Table 2.--Risk Classification
------------------------------------------------------------------------
Probability
Hazard location of failure Product/volume Risk
indicator indicator indicator classification
------------------------------------------------------------------------
H Any.......... Any combination...... C
------------------------------------------------------------------------
H............ H/H.................. C
M M............ Any combination...... B
L............ L/L.................. A
------------------------------------------------------------------------
H............ H/H.................. B
L M............ Any combination...... B
L............ L/L.................. A
------------------------------------------------------------------------
H=High, M=Moderate, L=Low.
Table 6.--Probability of Failure Indicators (in each haz. location)
------------------------------------------------------------------------
Indicator Failure history (Time-Dependent Defects)
------------------------------------------------------------------------
H Release >1000 bbls in last 5 years.
M 1 or more reportable incidents in last 5
years.
L 0 reportable incidents in last 5 years.
------------------------------------------------------------------------
The API's proposal on risk-based alternative to the pressure
testing rule is attached to this notice. RSPA is seeking comment on any
of the above-described matters.
Issued in Washington, D.C. on March 4, 1996.
Richard B. Felder,
Associate Administrator for Pipeline Safety.
BILLING CODE 4910-60-M
[[Page 9417]]
[GRAPHIC] [TIFF OMITTED] TP08MR96.005
BILLING CODE 4910-60-C
[[Page 9418]]
API'S RISK-BASED ALTERNATIVE TO THE HYDROTEST RULE
Note: Italicized comments are included in order to help clarify
the accompanying text of this proposed alternative to the Hydrotest
Rule.
Risk-Based Hydrotest Rule
All previously grandfathered Class B and Class C pipeline segments,
and Class A pipeline segments containing ``High Hazard'' pre-1970 ERW
pipe shall either:
1. Show that a past pressure test has been completed. (Proof of a
past pressure test has been demonstrated when records can be (recording
charts, logs, applicable test specifications, employee or inspector log
books or other company or project records made at the time of the test
and which result directly from that test), the preponderance of which
substantiates a successfully completed past test at 125% of the maximum
operation pressure); or
2. Re-establish a maximum operating pressure at 80% of the highest
operating pressure to which the pipeline was subjected for more than
four or more continuous hours, which can be demonstrated by recording
charts or logs made at the time the operations were conducted; or
3. Re-establish a maximum operating pressure in accordance with
Subpart E--Pressure Testing and Table 1.
All previously grandfathered Class A pipeline segments that do not
contain ``High Hazard'' pre-1970 ERW pipe and non-HVL pipelines which
operate at less than 20% of SMYS are excepted from the above
requirements. See Tables 2-5 for definitions of Class A, B, and C
facilities. For the purposes of this rule, all pipeline segments
containing ``High Hazard'' pre-1970 ERW pipe and considered a Class C
or B facility shall be treated as the top priority for testing because
of the higher risk which may exist due to susceptibility to
longitudinal seam failures.
In all cases, operators should periodically review their facilities
in order to reassess the classification which has been designated.
Pipeline failures, changes in the characteristics of the pipeline
route, or changes in service should all trigger a reassessment of the
originally designated classification.
API's Risk-Based Alternative to the Hydrotest Rule
**Comment: The following Table defines 4 levels of test
requirements depending on the inherent risk of a given pipeline
segment. The overall risk classification is determined based on the
type of pipe involved, the facility's location, the product
transported, and the relative volume of flow as determined from Tables
2-5.**
Table 1.--Test Requirements--Mainline Segments Outside of Terminals, Stations, and Tank Farms
----------------------------------------------------------------------------------------------------------------
Pipeline Segment Classification Test deadline \1\ Test medium
----------------------------------------------------------------------------------------------------------------
``High Hazard'' Pre-70 Pipeline Class C or B........... 3 yrs \3\............. Water only.
Segments.\2\
Class A................ 5 yrs \3\............. Water only.
All Other Pipeline Segments......... Class C................ 5 yrs \4\............. Water only.
Class B................ 9 yrs \4\............. Water/Liq. \5\
Class A................ Additional pressure
testing not required.
----------------------------------------------------------------------------------------------------------------
\1\ If operational experience indicates a history of past failures for a particular pipeline system, failure
causes shall be reviewed to determine whether the timing of the pressure test should be accelerated.
\2\ All pre-1970 ERW pipeline segments may not require testing. All pre-1970 ERW pipe is not subject to the same
susceptibility to longitudinal seam failures. In determining which ERW pipeline segments should be included in
this category, operators should consider such factors as: the seam-related leak history of the pipe and pipe
manufacturing information as available, which may include the pipe steel's mechanical properties, including
fracture toughness; the manufacturing process and controls related to seam properties, including whether the
ERW process was high-frequency or low-frequency, whether the weld seam was heat treated, whether the seam was
inspected, the test pressure and duration during mill hydrotest; the cleanliness and quality control of the
steel-making process; and, other factors pertinent to seam properties and quality.
\3\ For those pipeline operators with extensive mileage of pre-1970 ERW pipe, any waiver requests for timing
relief should be supported by an assessment of hazards in accordance with location, product, and volume
considerations consistent with Tables 3, 4, and 5.
\4\ A magnetic flux leakage or ultrasonic internal inspection survey may be utilized as an alternative to
hydrotesting where leak history and operating experience do not indicate leaks caused by longitudinal cracks
or seam failure.
\5\ Pressure tests utilizing a hydrocarbon liquid may be conducted, but only with a liquid which does not
vaporize rapidly.
API's Risk-Based Alternative to the Hydrotest Rule
**Comment: Using LOCATION, PRODUCT, and VOLUME ``Indicators'' from
Tables 3, 4 and 5, the overall risk classification of a given pipeline
or pipeline segment can be established from Table 2. The LOCATION
Indicator is the primary factor which determines overall risk, with the
PRODUCT and VOLUME Indicators used to adjust to a higher or lower
overall risk classification per the following table.**
Table 2.--Facility Classification--Pipeline Segments
------------------------------------------------------------------------
Location indicator Product/Volume Indicators Classification
------------------------------------------------------------------------
H................. Any combination................. Class C.
H/H............................. Class C.
M................. All other combinations.......... Class B.
L/L............................. Class A.
L................. H/H............................. Class B.
All other combinations.......... Class A.
------------------------------------------------------------------------
Note: For Location and Product/Volume Indicators, see Tables 3,
4 and 5.
Risk-Based Alternative to the Hydrotest Rule
**Comment: Tables 4 and 5 are used to establish the PRODUCT and
VOLUME Indicators used in Table 2. The PRODUCT Indicator is selected
from Table 4 as H, M, or L based on the acute and chronic hazards
associated with
[[Page 9419]]
the product transported. The VOLUME Indicator is selected from Table 5
as H, M, or L based on the nominal diameter of the pipeline.**
Table 4.--Product Indicators
------------------------------------------------------------------------
Indicator Considerations Product examples
------------------------------------------------------------------------
H................... Highly volatile and Propane, butane, NGL,
flammable. ammonia.
Highly toxic............ Benzene, high H2S
content crude oils.
M................... Flammable--flashpoint<10 Gasoline, JP4, low
0F. flashpoint crude oils.
L................... Non-flammable-- Diesel, fuel, oil,
flashpoint 100+F. kerosene, JP5, most
crude oils.
Highly volatile and non- CO2
flammable/non-toxic.
------------------------------------------------------------------------
Considerations: The degree of acute and chronic toxicity to humans,
wildlife, and aquatic life; reactivity; and, volatility, flammability
and water solubility determine the Product Indicator. CERCLA RQ
(Reportable Quantity) values can be used as an indication of chronic
toxicity. NPA health factors can be used for rating acute hazards.
Table 5.--Volume Indicators
------------------------------------------------------------------------
Indicator Line size
------------------------------------------------------------------------
H.................................... 18''
M.................................... 10''-16'' nominal diameters.
L.................................... 8'' nominal diameter.
------------------------------------------------------------------------
API'S Risk-Based Alternative to The Hydrotest Rule
**Comment: Table 3 is used to establish the LOCATION indicator used
in Table 2. Based on the population (and possibly, in the future,
environmental) characteristics associated with a pipeline facility's
location, a LOCATION Indicator of H, M or L is selected. Please note
that the identification of those areas which are unusually sensitive to
environmental damage (which will affect these LOCATION Indicators) is
currently being addressed by OPS. These deliberations will determine
the final characterizations of Environment LOCATION Indicators.
Table 3.--Location Indicators--Pipeline Segments
------------------------------------------------------------------------
Indicator Population\1\ Environment
------------------------------------------------------------------------
H..................... Non-rural areas...... Currently, only
population (rural or non-
rural) will determine
the LOCATION indicator.
Once a definition of
``unusually sensitive
areas'' has been
established, the higher
of the Population or
Environment Indicator
will determine the
overall LOCATION
Indicator.
M..................... ..................... See above.
L..................... Rural areas.......... See above.
------------------------------------------------------------------------
\1\Pipeline segments transporting highly volatile or toxic products
should consider the effects of potential vapor migration.
[FR Doc. 96-5489 Filed 3-7-96; 8:45 am]
BILLING CODE 4910-60-M
Complete official Federal Register PDF
FR Doc. 96-5484 Privatization of In-plant Seafood Inspections and Related Services
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9420-9422]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5484]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Oceanic and Atmospheric Administration
50 CFR Part 260
[Docket No. 950915231-6051-02; I.D. 120195B]
RIN 0648-AI45
Privatization of In-plant Seafood Inspections and Related
Services
AGENCY: National Marine Fisheries Service, National Oceanic and
Atmospheric Administration (NOAA), Commerce.
ACTION: Notice of availability; public meetings.
-----------------------------------------------------------------------
SUMMARY: On September 22, 1995, NOAA published a notice of inquiry in
the Federal Register regarding in-plant seafood inspections and related
services under the Agricultural Marketing Act of 1946 (the Act). It
outlined an action NOAA was considering to provide direct inspection
services by a private, for-profit entity, with continued NOAA
oversight, and invited written recommendations and comments. The
document also noted that NOAA had contracted for a study to determine
the feasibility of implementing the plan. This document provides a
summary of the comments and recommendations, the results of the study,
describes NOAA's future actions, and announces meetings.
DATES: See SUPPLEMENTARY INFORMATION for meeting dates.
ADDRESSES: For copies of the feasibility study, contact the Director,
Office of Industry Services, 1315 East-West Highway, Room 12553, Silver
Spring, MD 20910. See SUPPLEMENTARY INFORMATION for meeting locations.
FOR FURTHER INFORMATION CONTACT: Sam McKeen, Director, Office of
Industry Services at (301) 713-2355.
SUPPLEMENTARY INFORMATION: On September 22, 1995, NOAA published a
notice of inquiry in the Federal Register (60 FR 49242), regarding the
way it delivers in-plant seafood inspections and related services under
the Act. The inquiry outlined an option NOAA was considering and
invited written comments and suggestions. Under that option, direct
inspection services would be provided by private parties with continued
NOAA oversight. The inquiry recommended that comments take into account
the following criteria that would fundamentally affect the viability of
a privatized inspection program: (1) fair treatment of Government
inspectors currently providing the services; (2) minimum modification
of relationships with customers subscribing to the current program, and
assurance that the internal operations of these customers need not be
changed to accommodate a privatized system; (3) continued recognition
by foreign governments of official indicia as indicating safety,
wholesomeness and acceptability of products to which the indicia are
affixed or to which they relate; (4) acceptance of the integrity of the
privatized inspection program by harvesters, processors, wholesalers,
retailers and consumers; and (5) likelihood of the continued economic
viability of the private entity (or entities) providing the services
into the indefinite future.
The approach that NOAA described in some detail involved the
establishment of a private, employee-owned Corporation (the
Corporation) that would acquire the voluntary seafood inspection
program (the Program) and operate it subject to the oversight of NOAA.
NOAA employees could become employees of the Corporation if they so
elected, and would acquire an ownership interest therein by means of an
Employee Stock Ownership Plan (ESOP). The Corporation would not
necessarily be the only authorized entity to provide privatized
inspection services. Other entities could apply to the Secretary of
Commerce for authorization, and if they met applicable requirements
(e.g., number of certified inspectors, percent of income from one
source), they would also be authorized to conduct the services.
The inquiry also mentioned NOAA's plan to contract for a study to
determine the feasibility of establishing an ESOP. It stated that if
the study, discussions with affected or interested persons, or comments
resulting from the inquiry indicate that the five criteria essential
for the success of a privatized system are not likely to be met by the
preferred option, NOAA will pursue other options for reinventing the
way it delivers the service to the public.
Under NOAA Administrative Order 205-11, 7.01, dated December 17,
1990, the Under Secretary for Oceans and Atmosphere has delegated
authority to sign material for publication in the Federal Register to
the Assistant Administrator for Fisheries, NOAA.
This document has been determined to be not significant for
purposes of E.O. 12866.
Comments
The inquiry generated 88 responses during the formal comment
period, most of which addressed the general concept of privatization.
The responses included comments from seafood processors, seafood trade
organizations, food marketing organizations, consumer advocacy groups,
and interested agencies of the Federal Government. Responders
categorized themselves as follows:
Seafood processors/wholesalers/distributors - 32
Employees - 29
State and Federal Government agencies - 7
Seafood retailers - 6
Trade associations - 4
Consumer groups - 2
Members of congress - 2
Private consultants - 2
Private citizens - 2
A total of 86 comments opposed privatization (whether by ESOP or
other, related means). Several responders who are current participants
in the program stated that if the program were privatized, they would
drop out of the program and hire their own inspectors. Comments that
specifically addressed the ESOP proposal opposed it. Of the comments
opposing transfer of the inspection function to the private sector, 59
did not discuss other options that might be preferable to the current
situation. A further 13 of the negative comments recommended
transferring the program to the U.S. Department of Agriculture or the
U.S. Food and Drug Administration. Discussions with those agencies
regarding transfer of the program were conducted prior to publication
of the notice of inquiry in the Federal Register. Neither agency was
interested in taking over the
[[Page 9421]]
program. NOAA has, therefore, concluded that attempting to pursue that
option further would not be useful. An additional 14 commenters who
opposed transferring the program to a for-profit entity suggested
formation of a ``government enterprise'' as a mechanism to ensure that
the criteria outlined in the inquiry could be met while allowing a
change in program structure to increase its efficiency.
Two comments supporting privatization were received from private
inspection entities, one of which was a not-for-profit organization
currently involved in standards-setting and inspection activities
pursuant to government programs throughout the world. That organization
expressed interest in assuming administration and operation of the
entire voluntary seafood program.
Generally, each response opposing the proposal addressed concerns
categorized and quantified as follows along with some of the comments:
(1) The integrity of the program would be in jeopardy--44 comments
Concerns revolve around the integrity of a private company funded
by the very industry it inspects. This may be a conflict of interests.
Federal inspectors are perceived to be objective.
(2) Acceptance by foreign markets either would not occur or was
doubtful--38 comments
``Failure to maintain foreign confidence in our U.S. inspection
program could result in serious economic problems for U.S. industry * *
*this puts nearly 500 jobs and approximately $200 million of annual
business [of the commenter] unnecessarily at risk.''
(3) The cost of the service would increase--34 comments
Commenters feel that Commerce fees have been based on a realistic
non-profit basis and that private inspection is bound to cost more. The
felt that seafood is already expensive; it would be impossible to
absorb the extra costs and difficult to pass these additional costs
along to the public.
(4) The proposal is contrary to the purpose of reinventing
government--53 comments
One of the commenters stated that the proposal is not consistent
with the clear intent of the Federal Workforce Restructure Act of 1994,
H.R. 3345, that was signed into law with the clear mandate of promising
``the American people that we would create a Government that works
better and costs less.'' (Bill Clinton, March 30, 1994)
(5) A private entity conducting inspection services would not be
accepted by consumers--23 comments
Commenters are concerned about losing the ability to use the
Federal inspection marks. They feel that it is the best way to
communicate to their customers that their products meet Federal quality
standards.
(6) The proposal would result in unfair treatment of inspectors and
their livelihood may be compromised--23 comments
Commenters are concerned whether employee wages and total benefits
would be equal to their current wages and benefits; inspectors would
receive credit for seniority; privatization would offer equal pay and
benefits; and whether employees would be treated fairly. They felt that
failure to provide equal pay and benefits would lead to disruption in
the work place.
(7) The economic viability of the program would be lost--20
comments
One commenter stated that if privatization of the inspection
services occurs, their USDC inspection programs, or equivalent would
have to be discontinued.
The Feasibility Study
The feasibility study analyzed seven options based on the degree to
which they satisfied several criteria which, by NOAA's instruction,
were unweighted in terms of importance. These criteria were based on
those identified in the Federal Register document published on
September 22, 1995. The study then summarized the feasibility of
implementing these options. The options were devolution (turning
inspection services over to the states), government corporation,
contracting out, turning the program over to a non-profit corporation
or to one of three types of private for-profit corporations. The study
contractor researched existing ESOPs and other corporations and
reviewed the program's legislative authorities and requirements. The
study contractor interviewed inspectors, industry members who
participate in the voluntary inspection program, and trade
associations. The final report was formally presented to NOAA on
November 30, 1995.
The contractor noted in its letter transmitting the final report
that if preserving program integrity and minimizing negative impact on
the inspection program customers are priorities, the analysis suggests
that the Government Corporation option would be preferred. If, on the
other hand, Commerce/NOAA's priority is to the maximize the financial
access of the new organization and achieve the target employee
reduction (the original impetus for the privatization analysis), the
ESOP/Strategic Investor option (described in the document published in
the Federal Register on September 22, 1995) best satisfies this
combination of criteria. The report recommended that NOAA further
analyze these two preferred options to determine which best satisfies
the outlined criteria. Copies of the report are available from this
office (see ADDRESSES).
NOAA's Future Action
In light of the comments received on the proposal to transfer
inspection responsibilities under the voluntary seafood inspection
program to a private, for-profit entity, NOAA has decided that it would
be more in keeping with the spirit of the National Performance Review
(NPR) and the interests of seafood producers and consumers to look to a
different type of enterprise to continue this important work. The range
of acceptable options has shifted as a result of the comments received.
A for-profit, private enterprise is no longer under consideration.
Possible options now appear to range from Government enterprise to a
not-for-profit, private enterprise combining recognized experience and
integrity with the technical and financial ability to assume
responsibility for the entire program. The Government enterprise could
take the form of a Government corporation or a ``performance- based,
consumer-oriented'' agency extracted from NMFS supervision, directly
responsible to the Administrator of NOAA or his/her designee and
relieved from unnecessary bureaucratic constraints.
The Government corporation would be a separate, legal entity,
created by Congress pursuant to the Government Corporation Control Act
of 1945. The Government Corporation Control Act is not a general
incorporation statute, so that each Government corporation possesses
only those powers set forth in its charter, which itself must be an Act
of Congress. The feasibility study recommended some charter provisions
for a Government corporation that would be useful. These included
authority to retain and use revenues without fiscal year limitation,
exemption from the Federal Property and Administrative Services Act,
and exemption from employee limitations without changing the Federal
status of the employees.
The NPR is developing a series of initiatives in the context of
constrained resources where good customer service will be an
imperative. Creating performance-based agencies is one of these
initiatives. The NPR is assisting agencies to change their internal
cultures to create these performance-based, customer-oriented
organizations.
[[Page 9422]]
The performance-based, customer-oriented organization would no longer
be a component of the National Marine Fisheries Service, but would
remain a Government agency within NOAA, providing services to the
public under the policy oversight of the Administrator or his/her
designee. It would be headed by a chief executive officer who would be
accountable for achieving results. The new agency would have statutory
authority to vary the rules for procurement, employees, etc., that
ordinarily apply to federal agencies. Creation of a performance-based
agency, like the creation of a Government corporation, would require
Congressional action.
Implementation of the not-for-profit option, would require
legislation authorizing NOAA to enter into a binding, long-term
arrangement with a selected, private entity. The legislation would also
establish conditions relating to the qualifications of the private
sector partner, the rights of employees to transfer to the private
entity, the legal acceptability of the examinations and certifications
of the private entity, measures to ensure the integrity of the system,
etc.
As indicated in the inquiry, the support of current customers and
other interested persons is essential to the ``reinvention'' of the
seafood inspection program in the time frame planned. NOAA desires to
accomplish this ``reinvention'' in the simplest possible way that is
acceptable to industry and consumers. Therefore, it will conduct
additional meetings with interested persons and organizations at
various locations in the United States according to the following
schedule to provide all interested persons an opportunity to present
further views on the remaining options. Prior to these meetings, a
draft discussion paper detailing one of the Government enterprise
options, this document and information about the specific meeting
locations will be mailed to those who attended earlier meetings or
received earlier correspondence from this agency on this issue. Other
interested parties may obtain this information by contacting this
office (see ADDRESSES).
The meeting dates and locations are as follows:
March 25, 1996--St. Petersburg, FL; March 26--Miami, FL; March 27--
Mobile, AL; March 28--Indianola, MS; April 1--Boston, MA; April 3--
Chicago, IL; April 4--Norfolk, VA; April 5-- Philadelphia, PA; April
9--Los Angeles, CA; April 10--Seattle, WA.
Dated: February 29, 1996.
Gary Matlock,
Program Management Officer, National Marine Fisheries Service.
[FR Doc. 96-5484 Filed 3-7-96; 8:45 am]
BILLING CODE 3510-22-F
Complete official Federal Register PDF
FR Doc. 96-5445 Ophthalmic Devices; Reclassification of Neodymium:Yttrium: Aluminum:Garnet (Nd:YAG) Laser for Peripheral Iridotomy
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9373-9377]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5445]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. 93P-0277]
Ophthalmic Devices; Reclassification of Neodymium:Yttrium:
Aluminum:Garnet (Nd:YAG) Laser for Peripheral Iridotomy
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; notice of panel recommendation.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is proposing to
reclassify the ophthalmic neodymium:yttrium:aluminum:garnet (Nd:YAG)
laser (mode-locked or Q-switched) intended for peripheral iridotomy
from class III (premarket approval) into class II (special controls).
The agency is also issuing for public comment the recommendation of the
Ophthalmic Devices Panel (the Panel) regarding the reclassification of
this device. The Panel made this recommendation after reviewing the
reclassification petition submitted by Intelligent Surgical Lasers,
Inc. (ISL). FDA is also issuing for public comment its tentative
findings on the Panel's recommendation and its intent to change the
generic designation of the device from Nd:YAG laser for posterior
capsulotomy to Nd:YAG laser for posterior capsulotomy and peripheral
iridotomy. After considering any public comments on the Panel's
recommendation and FDA's tentative findings, FDA will approve or deny
the reclassification petition by order in the form of a letter to the
petitioner. FDA's decision on the petition will be announced in the
Federal Register. If the petition is approved and the device is
reclassified into class II, FDA will publish a final rule to codify the
reclassification.
DATES: Written comments by June 6, 1996.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Morris Waxler, Center for Devices and
Radiological Health (HFZ-460), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, -301-594-2018.
SUPPLEMENTARY INFORMATION:
I. Introduction
On March 2, 1993, ISL submitted a petition under section 513(f)(2)
of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
360c(f)(2)), requesting that the ophthalmic Nd:YAG laser (mode-locked
or Q-switched) intended for peripheral iridotomy be reclassified from
class III into class II.
The subject device is automatically classified into class III under
section 513(f)(1) of the act because it is not within a type of device
that was introduced or delivered for introduction into interstate
commerce for commercial distribution before May 28, 1976, it is not
substantially equivalent to such a device, and it is not substantially
equivalent to a device placed in commercial distribution since May 28,
1976, which was subsequently reclassified into class II or class I.
Section 513(f)(2) of the act provides that FDA may initiate the
reclassification of a device classified into class III under section
513(f)(1) of the act, or the manufacturer or importer of the device may
petition the agency to reclassify the device into class I or class II.
FDA's regulations in 21 CFR 860.134 set forth the procedures for filing
and review of a petition to reclassify these class III devices. In
order to reclassify the ophthalmic Nd:YAG laser (mode-locked or Q-
switched) for peripheral iridotomy into class II, it is necessary that
the proposed new class has sufficient regulatory controls to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use.
II. Background
Nd:YAG lasers originally were developed for industrial
applications, and were successfully employed in such industries as
watchmaking prior to the initiation of clinical trials in Europe and
the United States. Therefore, the basic principles of operation of the
device
[[Page 9374]]
were scientifically established well before any clinical testing of the
device in ophthalmic surgery. -
Surgical iridectomies, i.e., manual surgical excisions of part of
the iris, were performed, with mixed results, in the late 1800's to
relieve the symptoms of glaucoma. In 1920, the differences between the
various types of glaucoma were described and it then became apparent
why the surgery relieved the symptoms of some patients and not others.
As a result, peripheral surgical iridectomies were then performed only
on patients with pupillary-block (angle-closure) glaucoma.
Argon laser iridotomies, surgery with an argon laser to create an
iris hole, became the preferred treatment for most cases of angle-
closure glaucoma in the 1970's. Although there were advantages to the
use of argon lasers (reduced risk of flat chamber, wound leak,
endophthalmitis, malignant glaucoma, and lens subluxation), there were
different complications associated with the new modality (permanent
corneal burns, retinal burns, iritis, localized cataract formation,
posterior synechiae, failed patency, intraocular pressure (IOP) rises
and iris pigmentation).
The next treatment modality, iridotomy with the Q-switched Nd:YAG
laser, was introduced during the early 1980's to treat angle-closure by
a mechanical cutting effect to create peripheral iridotomies rather
than the thermal effect of argon lasers. Because the technology
permitted tissue disruption through a transparent medium with
negligible heat generation, the Nd:YAG laser appeared to be ideal for
ophthalmic surgery on opacified posterior capsular membranes, thus
avoiding the risks involved in traditional invasive surgery as well as
the thermal effects characteristic of other ophthalmic laser devices.
Clinical trials were conducted and, subsequently, FDA granted premarket
approval for three CooperVision Nd:YAG lasers (models 2000 and 2500 in
1985; model 2300 in 1986) for discission of the posterior capsule of
the eye (posterior capsulotomy).
On January 24, 1986, the Medical Laser Manufacturers Association
(MLMA) submitted to FDA, under section 513(e) of the act and 21 CFR
860.120, a petition for a change in the classification of the
ophthalmic Nd:YAG laser (mode-locked or Q-switched) intended for
posterior capsulotomy. On February 20, 1986, the MLMA amended its
petition to include section 513(f)(2) of the act and 21 CFR 860.134 of
the regulations as a basis for its requested relief. The petition
requested that the ophthalmic Nd:YAG laser (mode-locked or Q-switched),
intended for posterior capsulotomy, be reclassified from class III into
class II. FDA referred the petition to the Panel for its recommendation
as to whether the device should be reclassified. On May 22, 1986,
during an open public meeting the Panel recommended that FDA reclassify
the device from class III into class II when intended for use in
posterior capsulotomy. The Panel identified the following devices as
examples of the generic type of device: The Meditec OPL-3, the M-Tec
2000, the Horizon 2000, the Horizon 2500, and the YAG-100.
The Panel also recommended that this generic type of device be
identified as the ``Nd:YAG laser for posterior capsulotomy.'' On
December 14, 1987 (52 FR 47454), FDA published in the Federal Register
a notice announcing the Panel's recommendation. On March 31, 1988, FDA
ordered (by letter to MLMA) the reclassification of the Nd:YAG laser
intended for posterior capsulotomy and substantially equivalent devices
of this generic type from class III into class II.
On March 2, 1993, ISL submitted to FDA, under section 513(f) of the
act, a petition requesting reclassification of the ophthalmic Nd:YAG
laser (mode-locked or Q-switched) intended for peripheral iridotomy
from class III into class II (Ref. 1). The agency referred the petition
to the Panel for its recommendation on the requested change in
classification.
III. Recommendation of the Panel
The Panel met on October 28, 1993, in an open public meeting to
discuss the subject device. After considering the published studies,
published data on laser parameters for safe and effective Nd:YAG
iridotomy, and the guidelines for laser iridotomy published by the
American Academy of Ophthalmology (Ref. 2), the Panel recommended that
the ophthalmic Nd:YAG laser (mode-locked or Q-switched) intended for
peripheral iridotomy be reclassified from class III into class II. The
Panel believed the petitioners had presented sufficient data to
demonstrate that special controls can be established to provide
reasonable assurance of the safety and effectiveness of the device for
its intended use. The Panel also noted that the procedure is well
understood and widely used by most ophthalmologists in the United
States, as evidenced by the discussion of the Panel members (Ref. 3 p.
83).
IV. Device Description
The ophthalmic Nd:YAG laser intended for peripheral iridotomy
consists of a mode-locked or Q-switched solid state Nd:YAG laser that
generates short pulse, low energy, high power, coherent optical
radiation. When the laser output is combined with focusing optics, the
high irradiance at the target site causes tissue disruption via optical
breakdown. A visible aiming system is utilized to target the invisible
Nd:YAG laser radiation on or in close proximity to the target tissue.
A. Principles of Operation
The Nd:YAG laser is one component of a device system that also
includes conditioning optics, a delivery system, an aiming system, and
operator controls. Its laser beam must be shaped by conditioning optics
to a configuration with a specific profile and desired characteristics.
The physical properties of the Nd:YAG laser beam that directly
influence the ability of the device to perform its intended function
safely and effectively are its invisible infrared beam at a wavelength
of 1,064 nanometers, output pulse generating method, output energy,
pulse width, spatial mode, convergence angle, spotsize, and pulse
repetition frequency. The only variable that is selected by the
ophthalmic surgeon during the iridotomy procedure is the device's
output energy.
While other types of lasers (e.g., the argon laser) used for
ophthalmic surgery employ long duration exposures to achieve thermal
tissue effects for photocoagulation, tissue cutting, or tissue
destruction, the ophthalmic Nd:YAG laser (mode-locked or Q-switched)
intended for peripheral iridotomy uses very short duration exposures
(pulses) that are focused precisely to small spot sizes and that
produce a high local irradiance (power density). The combination of
short exposure duration and high irradiance results in nonlinear
absorption of the radiation by the target tissue, causing tissue
disruption through optical breakdown. The plasma generated by the
process of optical breakdown provides protection for posterior tissue
in direct line with the incident beam. These unique characteristics
permit the ophthalmic Nd:YAG laser to perform a patent iridotomy with
reduced inflammation, regardless of iris pigmentation.
B. Device Specifications
Mode-locked laser output consists of a train of 7 to 10 pulses with
a pulse duration of about 30 nanoseconds and a pulsewidth of about 30
picoseconds. Q-switched laser output consists of single pulses, with
pulsewidths of about 2 to 20 nanoseconds in duration.
[[Page 9375]]
The typical threshold of optical breakdown of tissue in air for
mode-locked lasers is 1014 watts per centimeter squared, and for
Q-switched lasers is 1011 watts per centimeter squared. The
threshold for optical breakdown of tissue in an aqueous environment
appears to be lower but varies depending upon the nature of the tissue.
For disruption of the iris of the eye, an energy setting of 4.0 to 6.0
millijoules results in optical breakdown creating the desired tissue
effect after application of 1 to 4 bursts that contain 1 to 4 pulses/
burst (Refs. 10, 11, 12, 13, 14, and 15).
In addition to the laser, the other two main components of the
system subject to the petition are a visible light beam aiming system
and a slit-lamp biomicroscope used by the operator to target the
treatment laser beam and to visually monitor the treatment process.
V. Summary of Reasons for the Recommendation
The Panel based its recommendation on the data and information
contained in the petition and presented during the open committee
discussion during the Panel meeting on October 28, 1993. After review
and consideration of the available information, the Panel gave the
following reasons in support of its recommendation to reclassify the
generic type ophthalmic Nd:YAG laser (mode-locked or Q-switched)
intended for peripheral iridotomy from class III into class II:
(1) The device is not an implant.
(2) General controls by themselves are insufficient to provide
reasonable assurance of the safety and effectiveness of the device.
(3) There is sufficient publicly available information to establish
special controls to assure the performance of the device for its
intended use. Also, there is sufficient publicly available information
to demonstrate that the risks to health have been determined, and that
the relationship between the device's performance parameters and risks
and its safety and effectiveness have been established by valid
scientific evidence.
(4) Various safety features of medical lasers are already
controlled by existing FDA standards (21 CFR 1040.10 and 1040.11)
promulgated under the Radiation Control for Health and Safety Act of
1968 (42 U.S.C. 263b).
The Panel believed that the following devices identified in the
petition are representative of the generic type of device: the NIDEK
YAG-100; the NIDEK 200; the Coherent 9900; and the Meridian LASAG MR-2.
VI. Risks To Health
Based on publicly available information establishing that it can
successfully perform a discission of the iris (iridotomy), the Panel
concluded that the ophthalmic Nd:YAG laser (mode-locked or Q-switched)
intended for peripheral iridotomy is effective for its intended use.
The Panel also determined that the foreseeable risks to health
associated with the device are related to either unintentional damage
to nontarget tissue or postoperative complications resulting from user
error or device malfunction. These risks include corneal damage or
edema, iritis, corectopia, lenticular opacities, retinal damage,
transient elevation of IOP, failure to obtain iridotomy, precipitation
of angle-closure attack, late closure of iridotomy, and iris atrophy.
The risks of these adverse effects have been documented to be low and
acceptable when the device is used in accordance with its directions
and appropriate postoperative care is followed.
The use of the Nd:YAG laser for peripheral iridotomy may be
contraindicated for patients without a clear cornea or aqueous,
patients with chronic uveitis, patients with a tendency to bleed,
patients on anticoagulant therapy, and patients with a glass
intraocular lens.
VII. Summary of Data Upon Which the Recommendation is Based
During its review and discussion of the petition, the Panel paid
close attention to the risks associated with the use of the device. The
clinical studies included in the petition reported few risks to health,
and the few that were reported were clearly identified. The Panel
concluded that special controls can be established to provide
reasonable assurance of the safety and effectiveness of the device when
intended for peripheral iridotomy. The incidence rates of iridotomy
closure, vision loss due to progression of laser induced lens or
corneal damage, additional filtration surgery, transient iris bleeding,
transient IOP spike, focal lens opacities, nonprogressive corneal
endothelial changes, retinal damage, focal corneal opacities, mild
iritis, and hyphema associated with Nd:YAG laser iridotomy are either
lower than those for argon laser surgery or conventional surgical
iridotomy or are self-limiting and not persistent.
Del Priore, et al. (Ref. 4) compared iridotomies using the Nd:YAG
laser and argon laser in a prospective, randomized clinical study. The
study focused on 43 patients (86 eyes) followed for 20 months (mean
followup time 27 7 months). The mean preoperative visual
acuity in the argon treated and the Nd:YAG treated eyes was 6/12
3 Snellen lines and did not change postoperatively. No
retinal detachments or laser burns of the macula were detected.
Iridotomy closure was not observed in any of the Nd:YAG laser treated
eyes, but 9 (21 percent) argon iridotomies required retreatment. Visual
loss due to progression of laser induced lens or corneal damage was not
observed in any eye. Nine of 43 (21 percent) argon laser treated eyes
and 8 of 43 (19 percent) Nd:YAG laser treated eyes required laser
trabeculoplasty for further intraocular pressure lowering after
iridotomy. Transient iris bleeding was encountered in 19 (44 percent)
Nd:YAG laser treated eyes, but was not seen in any argon treated eyes.
Six (32 percent) of the eyes with transient bleeding had IOP elevations
greater than 10 millimeters (mm) Hg within the first 3 hours, and the
IOP spike was greater than 20 mm Hg in four (17 percent) of these eyes.
Focal opacification of the anterior lens capsule was seen in 23 (53
percent) argon laser treated eyes and none of the Nd:YAG laser treated
eyes. This difference is statistically significant (P<0.01). Focal
corneal endothelial opacities were encountered in 13 (30 percent)
Nd:YAG laser treated and 11 (26 percent) argon laser treated eyes.
Neither type of opacity enlarged clinically, and both tended to
regress. Clinically significant corneal edema or corneal decompensation
did not develop in the eyes of either treatment group during long term
followup. Although several different Nd:YAG lasers (AM YAG-100
(American Medical Optics), Coherent JK Nd:YAG, and Coherent 9900) were
used in the study, no differences were indicated by the results. The
Nd:YAG laser offers intraoperative advantages in patients who cannot
maintain a steady head position and fixation, and is independent of
iris color. The Nd:YAG laser is also regarded as the treatment of
choice in most patients with chronic pupillary-block glaucoma (Ref. 4).
In other studies, Fleck, et al. (Ref. 5) compared Nd:YAG laser
iridotomy with and without argon laser pretreatment and concluded that
argon laser pretreatment offers no advantage over primary Nd:YAG laser
iridotomy. On the other hand, Goins, et al. (Ref. 6) found that argon
laser pretreatment significantly reduced the incidence of hemorrhage
during Nd:YAG iridotomy (p=0.012). Robin and Pollack (Ref. 7) found
that hyphema is not clinically significant when eyes are pretreated
with the argon laser. Of the Nd:YAG
[[Page 9376]]
iridotomies they studied, 67 percent (8/12) had operative hemorrhages,
while 17 percent (2/12) of the argon pretreated eyes had hemorrhages.
Robin and Pollack (Ref. 7) also reported a lower incidence of bleeding
when eyes were pretreated with the argon laser. McGalliard and Wishart
(Ref. 8) studied 81 eyes with shallow anterior chambers and raised IOP.
Iridotomies were performed to prevent further angle closure glaucoma
(ACG) and to remove pupillary block that could have contributed to the
raised IOP. In eyes where there was no peripheral anterior synechia
(PAS) there was no drop in IOP, but in eyes with well established PAS
69 percent showed a drop in IOP. Jiang (Ref. 9) also found a very
significant difference between the preoperative values and the
postoperative values at 3-year followup. In a study of 31 patients (40
eyes with persistent angle closure glaucoma (PACG)), the iridotomy
controlled the IOP, and the iridotomy hole closed spontaneously in four
eyes. The success rates were 94 percent at 6 months, 91 percent at 2
years, and dropped to 82.4 percent at the end of the third year.
Romano, et al. (Ref. 10) compared Nd:YAG iridotomy with conventional
surgical iridectomy. They found that in the nonlaser-treated group,
pilocarpine alone controlled the IOP. In the laser treated group, eyes
without PAS required fewer medications to maintain normal pressures
than eyes with PAS required.
Regarding Nd:YAG laser technique, March (Ref. 11) recommends that a
laser lens be used in performing a Nd:YAG laser iridectomy to aid in
the placement of the lesion on the iris. He also recommends iridectomy
placement beneath the upper lid if possible to avoid complications of
halos, blurring, horizontal bands of light, and diplopia secondary to
light transmission through the site postoperatively. Focusing on the
ability of the Nd:YAG laser to produce a patent iridotomy, Spaeth (Ref.
11) reviewed a prospective study of 58 patients in which the right eyes
were treated with the LASAG Microruptor 2 Nd:YAG laser and the left
eyes with a Britt argon laser, and concluded that the Nd:YAG laser can
indeed produce a patent iridotomy. He observed that there was a
significant pressure rise in one third of the cases treated and that
frequent hemorrhage occurred at the time of the iridectomy, but was not
so severe that a gross hyphema developed. In no instance of Nd:YAG
laser treatment was corneal endothelium or anterior lens capsule damage
noted. Completion of the iridectomy was made on the basis of
visualization of the lens through a hole in the iris. The IOP results
reported for both lasers indicated a rise in IOP at 1 hour
postoperative which decreased to the preoperative level 1 week
postoperative.
In two studies by Robin and Pollack (Refs. 7 and 12) using the
Coherent 9900 Q-switched and the AMO YAG-100 lasers, the authors
reported that hyphema was not clinically significant and was consistent
with other studies showing a lower incidence of bleeding for pretreated
argon eyes. In one study, 33 eyes (both brown and blue irises) from 28
patients with pupillary block glaucoma were treated. Study followup was
1 month. Twenty-six had previous argon laser iridectomies. All had
iridectomy closure within a week of argon treatment or there had been
failure to penetrate the iris; the preoperative IOP range was 8 mm to
74 mm Hg and was 10 mm to 43 mm Hg at 1-month followup. Complications
reported after use of the Coherent 9900 Q-switched Nd:YAG laser were
focal discrete nonprogressive corneal endothelial changes in six eyes
(18 percent), bleeding in 12 eyes (36 percent), and IOP greater than 10
mm Hg during the first 3 hours postoperatively in nine eyes (27
percent). No hyphema, laser-induced lens damage or retinal damage was
observed. Two iridectomies closed within days of treatment. Study
followup was 1 month.
In the second study, the authors studied 40 eyes (20 patients) in
which one eye was treated with an argon laser and the fellow eye with a
Q-switched YAG laser, an AMO YAG-100 (7 patients) or a Coherent JK
prototype (13 patients). Iris colors were blue and brown. At no time
was the IOP change significant between the argon laser and YAG laser
treated patients. Inflammation was seen in all patients. Of the argon
treated eyes, 12 had a rise in IOP during the first 3 hours
postoperatively. Six (30 percent) iridectomies required retreatment,
focal corneal opacities were seen in five (25 percent) of the argon
treated eyes, and posterior synechiae were seen in three (15 percent)
of the argon treated eyes. By comparison, thirteen YAG treated eyes had
an IOP rise during the first 3 hours and bleeding occurred in nine (45
percent), with one having less than 5 percent hyphema which cleared by
the first postoperative day. No iridectomy closures were seen, while
focal corneal opacities were seen in seven (35 percent) of the YAG
treated eyes. None of the YAG treated eyes suffered focal lenticular
opacity. Finally, the Panel noted the publication by the American
Academy of Ophthalmology, Laser Peripheral Iridotomy for Pupillary-
Block Glaucoma (Ref. 2), which discusses surgical iridectomy and laser
iridotomy techniques, treatment parameters, complications and patient
care, and provides insight in addressing laser iridotomy and the above
risks.
The Panel believes that the risks identified above that are
directly attributable to the Nd:YAG laser for peripheral iridotomy can
be controlled by special controls. The risks of damage to the corneal
endothelium, the lens, or the retina are slight. These risks can be
minimized by ensuring proper device design of the laser beam for
accuracy and precision. The risk of IOP rise can be controlled by
proper device labeling and by the surgeon through available,
established medical procedures and treatments. There is reasonable
assurance that an ophthalmic Nd:YAG laser (mode-locked or Q-switched)
is safe and effective for iridotomy when the device is used consistent
with appropriate labeling, designed in accordance with proper device
specifications and produced under a quality assurance program to ensure
that critical specifications are met within specified tolerances.
VIII. FDA's Tentative Findings
FDA tentatively concurs with the recommendation of the Panel that
the Nd:YAG laser intended for peripheral iridotomy should be
reclassified into class II and that the generic designation of the
device be changed from Nd:YAG laser for posterior capsulotomy to Nd:YAG
laser for posterior capsulotomy and peripheral iridotomy. The agency
also tentatively concludes that ``new information'' in the form of
publicly available, valid scientific evidence exists to provide
reasonable assurance of the safety and effectiveness of the Nd:YAG
laser for its intended use. Consistent with the purpose of the act,
class II controls (labeling) as defined by section 513(a)(1)(B) of the
act are sufficient to provide reasonable assurance that current Nd:YAG
lasers are safe and effective for their intended use.
IX. Environmental Impact
The agency has determined under 21 CFR 25.24(e)(2) that thisaction
is of a type that does not individually or cumulatively have a
significant effect of the human environment. Therefore, neither as
environmental assessment nor an environmental impact statement is
required.
[[Page 9377]]
X. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the regulatory philosophy and
principles identified in the Executive Order. In addition, the proposed
rule is not a significant regulatory action as defined by the Executive
Order and so is not subject to review under the Executive Order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because reclassification of devices from class III
into class II may relieve manufacturers of the cost of complying with
the premarket approval requirements in section 515 of the act, and may
permit small potential competitors to enter the marketplace by lowering
their costs, the agency certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
Therefore, under the Regulatory Flexibility Act, no further analysis is
required.
XI. Request for Comments
Interested persons may, on or before June 6, 1996, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m. Monday through Friday.
XII. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Reclassification Petition for the Nd:YAG Laser for Iridotomy,
submitted by Intelligent Surgical Lasers, Inc., March 2, 1993.
2. American Academy of Ophthalmology Guideline: Laser Peripheral
Iridotomy for Pupillary-Block Glaucoma, Approved by Board of
Directors, June 25, 1988. (Also contained in the petition.)
3. Transcript of the Ophthalmic Devices Panel Meeting, October
28, 1993.
4. Del Priore, L. V., A. L. Robin, and I. P. Pollack,
``Neodymium:YAG and Argon Laser Iridotomy: Long-term Followup in a
Prospective, Randomized Clinical Trial,'' Ophthalmology, 94(9):1205-
1211, 1988.
5. Fleck, B. W., E. Wright, C. McGlynn, ``Argon Laser
Pretreatment 4 to 6 Weeks Before Nd:YAG Laser Iridotomy,''
Ophthalmic Surgery, 22(11):644-649, 1991.
6. Goins, K., E. Schmeisser, T. Smith, ``Argon Laser in Nd:YAG
Iridotomy,'' Ophthalmic Surgery, 21(7):497-500, 1990.
7. Robin, A. L. and I. P. Pollack, ``Q-switched Neodymium-YAG
Laser Iridotomy in Patients in Whom the Argon Laser Fails,''
Archives of Ophthalmology, 104(4):531-535, 1986.
8. McGalliard, J. N., P. K. Wishart, ``The Effect of Nd:YAG
Iridotomy on Intraocular Pressure in Hypertensive Eyes with Shallow
Anterior Chambers,'' Eye, 4(6):823-829, 1990.
9. Jiang, Y. Q., ``The Long-term Effect of Nd:YAG Laser
Iridotomy,'' Chung-Hua Yn Ko Tsa Chih Chin, Journal of
Ophthalmology, 27(4):221-224, 1991.
10. Romano, J. H., R. A. Hitchings, and D. Pooinasawmy, ``Role
of Nd:YAG Peripheral Iridectomy in the Management of Ocular
Hypertension With a Narrow Angle,'' Ophthalmic Surgery, 19(11):814-
816, 1988.
11. March, W. F., and G. Spaeth, ``YAG Laser Iridectomy,
Complications,'' Ophthalmic Lasers (A Second Generation), Thorogare,
New York: Slack Inc., 1990.
12. Robin, A. L. and I. P. Pollack, ``A Comparison of
Neodymium:YAG and Argon Laser Iridotomies,'' Ophthalmology,
91(9):1011-1016, 1984.
13. Moster, M. R., et al., ``Laser Iridectomy, A Controlled
Study Comparing Argon and Neodymium:YAG,'' Ophthalmology, 93:20-24,
1986.
14. Cinotti, D. J., et al., ``Neodymium:YAG Laser Therapy for
Pseudophakic Pupillary Block,'' Journal of Cataract and Refractive
Surgery, 12:174-179, 1986.
15. Robin, A. L. et al, ``Q-switched Neodymium-YAG Iridotomy: A
Field Trial with a Portable Laser System,'' Archives of
Ophthalmology, 104:526-530, 1986.
List of Subjects in 21 CFR Part 886
Medical devices, Ophthalmic goods and services.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 886 be amended as follows:
PART 886--OPHTHALMIC DEVICES
1. The authority citation for 21 CFR part 886 continues to read as
follows:
Authority: Secs. 501, 510, 513, 515, 520, 701 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 351, 360, 360c, 360e, 360j,
371).
2. Section 886.4392 is amended by revising the section heading and
paragraph (a) to read as follows:
Sec. 886.4392 Nd:YAG laser for posterior capsulotomy and peripheral-
iridotomy.
(a) Identification. The Nd:YAG laser for posterior capsulotomy and
peripheral iridotomy consists of a mode-locked or Q-switched solid
state Nd:YAG laser intended for disruption of the posterior capsule or
the iris via optical breakdown. The Nd:YAG laser generates short pulse,
low energy, high power, coherent optical radiation. When the laser
output is combined with focusing optics, the high irradiance at the
target causes tissue disruption via optical breakdown. A visible aiming
system is utilized to target the invisible Nd:YAG laser radiation on or
in close proximity to the target tissue.
* * * * *
Dated: February 14, 1996.
D.B. Burlington,
Director, Center for Devices and Radiological Health.
[FR Doc. 96-5445 Filed 3-7-96; 8:45 am]
BILLING CODE 4160-01-F
Complete official Federal Register PDF
FR Doc. 96-5436 Radio Broadcasting Services; Esperanza, PR, Christiansted, VI
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)] [Proposed Rules] [Page 9410] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-5436] ======================================================================= ----------------------------------------------------------------------- FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 73 Radio Broadcasting Services; Esperanza, PR, Christiansted, VI AGENCY: Federal Communications Commission. ACTION: Proposed rule; dismissal of petition. ----------------------------------------------------------------------- SUMMARY: The Commission denies the petition for reconsideration filed by Esperanza Broadcasters which requests the allotment of Channel 258B to Esperanza, Puerto Rico, as the community's first local aural broadcast service. To accommodate the allotment at Esperanza, petitioner also requests the substitution of Channel 293B for Channel 258B at Christiansted, Virgin Islands, and the modification of Station WVIQ(FM)'s license accordingly. The Commission found that the petition was prematurely filed since it is contingent upon the outcome of the on-going proceeding in MM Docket 91-259 and that the petitioner failed to comply with the provisions of Section 1.401(d) which require that a copy of the petition be served on all affected licensees, in this case, the licensee of Station WVIQ(FM). FOR FURTHER INFORMATION CONTACT: Leslie K. Shapiro, Mass Media Bureau, (202) 418-2180. SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's Memorandum Opinion and Order, adopted February 20, 1996, and released March 4, 1996. The full text of this Commission decision is available for inspection and copying during normal business hours in the FCC Reference Center (Room 239), 1919 M Street, NW., Washington, DC. The complete text of this decision may also be purchased from the Commission's copy contractor, International Transcription Services, Inc., (202) 857-3800, 2100 M Street, NW., Suite 140, Washington, DC 20037. Federal Communications Commission. Douglas W. Webbink, Chief, Policy and Rules Division, Mass Media Bureau. [FR Doc. 96-5436 Filed 3-8-96; 8:45 am] BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-5433 Radio Broadcasting Services; Pullman, WA
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9410-9411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5433]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 96-27; RM-8750]
Radio Broadcasting Services; Pullman, WA
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Commission requests comments on a petition filed by Keith
E. Lamonica proposing the allotment of Channel 249A at Pullman,
Washington, as the community's third local commercial FM transmission
service. Channel 249A can be allotted to Pullman in compliance with the
Commission's minimum distance separation requirements with a site
restriction of 8. 8 kilometers(5.5 miles) east to avoid a short-spacing
to the construction permit site for Station WLKY(FM),Channel 250C1,
Milton-Freewater, Oregon. The coordinates for Channel 249A at Pullman
are North Latitude 46-44-37 and West Longitude 117-03-34. Since Pullman
is located within 320 kilometers (200 miles) of the U.S.-Canadian
border, concurrence of the Canadian government has been requested.
DATES: Comments must be filed on or before April 25, 1996 and reply
comments on or before May 10, 1996.
ADDRESSES: Federal Communications Commission, Washington, DC 20554. In
addition to filing comments with the FCC, interested parties should
serve the petitioner, or its counsel or consultant, as follows: Keith
E. Lamonica, 760 SE. Carolstar, Pullman, Washington 99163 (Petitioner).
FOR FURTHER INFORMATION CONTACT: Sharon P. McDonald, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Notice of Proposed Rule Making, MM Docket No. 96-27, adopted February
20, 1996, and released March 4, 1996. The full text of this Commission
decision is available for inspection and copying during normal business
hours in the FCC Reference Center (Room 239), 1919 M Street, NW.,
Washington, DC. The complete text of this decision may also be
purchased from the Commission's copy contractor, International
Transcription Service, Inc., (202) 857-3800, 2100 M Street, NW., Suite
140, Washington, DC 20037.
Provisions of the Regulatory Flexibility Act of 1980 do not apply
to this proceeding.
Members of the public should note that from the time a Notice of
Proposed Rule Making is issued until the matter
[[Page 9411]]
is no longer subject to Commission consideration or court review, all
ex parte contacts are prohibited in Commission proceedings, such as
this one, which involve channel allotments. See 47 CFR 1.1204(b) for
rules governing permissible ex parte contacts.
For information regarding proper filing procedures for comments,
see 47 CFR 1.415 and 1.420.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-5433 Filed 3-7-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-5432 Radio Broadcasting Services; Forest Acres, SC
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Page 9411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5432]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 96-25; RM-8752]
Radio Broadcasting Services; Forest Acres, SC
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Commission requests comments on a petition filed by Kuhel
Communications proposing the allotment of Channel 232A at Forest Acres,
South Carolina, as the community's first local aural transmission
service. Channel 232A can be allotted to Forest Acres in compliance
with the Commission's minimum distance separation requirements without
the imposition of a site restriction. The coordinates for Channel 232A
at Forest Acres are North Latitude 34-01-09 and West Longitude 80-59-
24.
DATES: Comments must be filed on or before April 25, 1996 and reply
comments on or before May 10, 1996.
ADDRESSES: Federal Communications Commission, Washington, DC 20554. In
addition to filing comments with the FCC, interested parties should
serve the petitioner, or its counsel or consultant, as follows: Shaun
A. Maher, Esq., Smithwick & Belendiuk, P.C., 1990 M Street, NW., Suite
510, Washington, DC 20036 (Counsel for Petitioner).
FOR FURTHER INFORMATION CONTACT: Sharon P. McDonald, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Notice of Proposed Rule Making, MM Docket No. 96-25, adopted February
16, 1996, and released March 4, 1996. The full text of this Commission
decision is available for inspection and copying during normal business
hours in the FCC Reference Center (Room 239), 1919 M Street, NW.,
Washington, DC. The complete text of this decision may also be
purchased from the Commission's copy contractor, International
Transcription Service, Inc., (202) 857-3800, 2100 M Street, NW., Suite
140, Washington, DC 20037.
Provisions of the Regulatory Flexibility Act of 1980 do not apply
to this proceeding.
Members of the public should note that from the time a Notice of
Proposed Rule Making is issued until the matter is no longer subject to
Commission consideration or court review, all ex parte contacts are
prohibited in Commission proceedings, such as this one, which involve
channel allotments. See 47 CFR 1.1204(b) for rules governing
permissible ex parte contacts.
For information regarding proper filing procedures for comments,
see 47 CFR 1.415 and 1.420.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-5432 Filed 3-7-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-5431 Radio Broadcasting Services; Booneville, KY
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Page 9411]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5431]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 73
[MM Docket No. 96-26; RM-8749]
Radio Broadcasting Services; Booneville, KY
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Commission requests comments on a petition filed by James
P. Gray proposing the allotment of Channel 287A at Booneville,
Kentucky, as the community's first local aural transmission service.
Channel 287A can be allotted to Booneville in compliance with the
Commission's minimum distance separation requirements without the
imposition of a site restriction. The coordinates for Channel 287A at
Booneville are North Latitude 37-28-36 and West Longitude 83-40-30.
DATES: Comments must be filed on or before April 25, 1996 and reply
comments on or before May 10, 1996.
ADDRESSES: Federal Communications Commission, Washington, DC 20554. In
addition to filing comments with the FCC, interested parties should
serve the petitioner, or its counsel or consultant, as follows: James
P. Gray, 10 Trinity Place, Fort Thomas, Kentucky 41075 (Petitioner).
FOR FURTHER INFORMATION CONTACT: Sharon P. McDonald, Mass Media Bureau,
(202) 418-2180.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Commission's
Notice of Proposed Rule Making, MM Docket No. 96-26, adopted February
16, 1996, and released March 4, 1996. The full text of this Commission
decision is available for inspection and copying during normal business
hours in the FCC Reference Center (Room 239), 1919 M Street, NW.,
Washington, DC. The complete text of this decision may also be
purchased from the Commission's copy contractor, International
Transcription Service, Inc., (202) 857-3800, 2100 M Street, NW., Suite
140, Washington, DC 20037.
Provisions of the Regulatory Flexibility Act of 1980 do not apply
to this proceeding.
Members of the public should note that from the time a Notice of
Proposed Rule Making is issued until the matter is no longer subject to
Commission consideration or court review, all ex parte contacts are
prohibited in Commission proceedings, such as this one, which involve
channel allotments. See 47 CFR 1.1204(b) for rules governing
permissible ex parte contacts.
For information regarding proper filing procedures for comments,
see 47 CFR 1.415 and 1.420.
List of Subjects in 47 CFR Part 73
Radio broadcasting.
Federal Communications Commission.
John A. Karousos,
Chief, Allocations Branch, Policy and Rules Division, Mass Media
Bureau.
[FR Doc. 96-5431 Filed 3-7-96; 8:45 am]
BILLING CODE 6712-01-F
Complete official Federal Register PDF
FR Doc. 96-5426 Cable Television Rate Regulation; Cost of Service Rules
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9411-9413]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5426]
-----------------------------------------------------------------------
FEDERAL COMMUNICATIONS COMMISSION
47 CFR Part 76
[MM Docket No. 93-215; FCC 95-502]
Cable Television Rate Regulation; Cost of Service Rules
AGENCY: Federal Communications Commission.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Commission adopted the Second Report and Order and First
Order on Reconsideration in MM Docket 93-215 to refine existing cost of
service rules and to create final rules governing standard cost of
service showings filed by cable operators seeking to justify rates for
regulated cable services. In a Further Notice of Proposed Rulemaking
[[Page 9412]]
(``FNPRM''), the Commission proposes use of an operator's actual debt
cost and capital structure to determine the final cost of capital (or
rate of return). The FNPRM requests comment regarding the method to
determine the value of equity and debt, including the use of a market
valuation of equity to establish the proportion of equity in an
operator's capital structure.
DATES: Comments are due May 7, 1996. Replies are due June 6, 1996.
FOR FURTHER INFORMATION CONTACT: Tom Power, Cable Services Bureau,
(202) 416-0800.
SUPPLEMENTARY INFORMATION: This is a synopsis of the Further Notice of
Proposed Rulemaking in MM Docket No. 93-215, FCC 95-502, adopted
December 15, 1995 and released January 26, 1996.
The complete text of this Further Notice of Proposed Rulemaking is
available for inspection and copying during normal business hours in
the FCC Reference Center (room 239), 1919 M Street, NW., Washington,
DC, and also may be purchased from the Commission's copy contractor,
International Transcription Services, Inc. (``ITS Inc.'') at (202) 587-
3800, 2100 M Street, NW., Suite 140, Washington, DC 20017.
I. Further Notice of Proposed Rulemaking
A. Non-Unitary Rates of Return
1. Although a unitary rate of return applied to all cable operators
simplifies the administrative burdens of estimating an operator's rate
of return, it squeezes a wide variety of risk profiles into the same
regulatory box. We tentatively conclude that risk variables among cable
operators may be sufficiently widespread to justify consideration of an
alternative rate of return methodology tailored more closely to the
financial circumstances of individual cable operators. At the same
time, we recognize the risk that individualized rates of return could
involve highly detailed and potentially burdensome capital cost
determinations in rate cases. Thus, if we adopt a more tailored rate of
return methodology, we will nonetheless retain the current presumptive
rate, and its concomitant procedures for overcoming that presumption,
as an alternative to any new methodology.
2. The capital markets have recognized a significant measure of
risk within the cable industry. Cable stocks trade at significant
premiums relative to the overall equity market and cable companies
often have high debt costs due to low investment grades. In addition, a
fair proportion of homes passed by cable do not subscribe to the
service, suggesting consumers and businesses do not regard cable as a
traditional utility service. We believe it may be necessary to
recognize such risk diversity in the cable industry and no longer
presume that a single rate of return should be applied to all cable
operators making cost of service showings. We seek comment on an
alternative to the presumptive 11.24% rate of return. This alternative
would provide an equity cost estimate that recognizes the historic
growth orientation of cable investors and would allow actual debt cost
and use company specific capital structures.
B. Cost of Equity
3. We propose to use the capital asset pricing model (``CAPM'') as
a method to estimate the cost of cable equity as an alternative to the
discounted cash flow (``DCF'') approach used in the initial Cost Order,
59 FR 17975 (April 15, 1994). As a general matter, the DCF method
relies heavily on the consistent payout of dividends as a key part of
its formula, a factor that does not apply generally to equities. The
absence of dividends may reflect fundamental differences in the
strategic nature of cable business operations and the operation of
companies whose stocks make up a broad stock index such as the S&P 400.
A formula designed to measure a future dividend or income stream may
not be an appropriate model for estimating the rate of return demanded
by investors who are willing to forgo an income stream in favor of
growth through reinvested cash flow. The CAPM attempts to quantify the
risk necessary to induce an investor to follow this kind of growth-
oriented strategy. Under CAPM, equity cost is calculated by assigning
an equity premium to a company's stock that is commensurate with the
stock's systematic risk (risk that cannot be avoided through equity
diversification). Under this model, a stock's equity rate of return is
equal to the risk-free rate (obtainable on a risk-free government debt
instrument) plus a premium based on the systematic risk of a given
security (the beta).
4. The Commission, in the Cost Order, decided against using the
CAPM to determine equity cost due to concerns that insider holdings and
monopoly profit expectations would distort the measurement of risk
associated with providing regulated cable services. Based on data
submitted in response to the Further Notice, we tentatively conclude
that it is unnecessary to reject alternative methods of measuring
equity cost. The Commission's initial decision to forgo the use of the
CAPM stemmed from a concern that insider decisions could overstate the
size of the risk premium assigned to cable stocks under the CAPM. A
systematic review of the relationship between insider holdings and
movements in stock price, however, was not conducted and data submitted
in response to the Further Notice, do not support the assertion that
cable insiders exaggerate the stock prices of their companies.
5. In addition, with respect to monopoly expectations in cable
stock prices, we do not have sufficient data to determine the extent of
the relationship, if any, between the existence of monopoly power and
the stock price volatility premium assigned to cable company stocks.
6. In establishing an equity cost for cable companies, we propose
to rely on data from the cable industry itself rather than forgo such
direct evidence of industry cost in favor of some other surrogate
industry or stock group. In the Cost Order, we developed an equity cost
estimate based on a selected quartile of the S&P 400. As set forth
above, however, we do not believe it necessary to eschew reliance on
betas of publicly-traded cable stocks as part of the cable equity cost
calculation. Using data submitted to the Commission in response to the
Further Notice, the Commission examined betas for 11 cable companies
that derive the vast majority of their revenues from regulated cable
services. Recognizing that cable industry investment in recent years
has focused on long term revenue potential from unregulated services,
we have limited our analysis of betas to the years 1987 through 1992.
Based on data submitted to the Commission, the average beta for cable
industry equity investment is 1.42. This indicates that, on average,
cable equities are 42% more volatile than the general stock market.
7. Because we propose to examine an investment period of several
years, we propose to use the risk-free rate of the average yields on
five-year U.S. Treasury Notes after 1987. Based on Federal Reserve
data, the average yield on five-year U.S. Treasury Notes from 1987
through the third quarter of 1995 is 7.27%. Although this yield exceeds
the current yield on five-year notes, this figure is an average that
accounts for numerous rate fluctuations over an extended time period.
We believe an average risk-free rate may be appropriate for selecting a
cost of equity for cable because the equity cost estimate would be
relied upon in cost of service filings for at least the period
preceding an operator's next major rate filing.
[[Page 9413]]
Moreover, we proposed to update this rate to account for subsequent
interest rate changes.
8. Consistent with the CAPM approach, we estimate the average
return on investment in the general equity market. Using the S&P 500
from 1987 through the third quarter of 1995, the average compounded
return has been 13.53%. Applying the CAPM formula, the general equity
market premium above the risk-free rate of return is 6.26% (13.53%-
7.27%). The 1.42 beta for cable equity investment multiplied by 6.26%
provides a cable equity premium of 8.89 percentage points above the
average risk-free rate. Adding the risk-free rate to the cable equity
premium results in an equity cost figure of 16.16%. We propose that the
average cost of equity for investment in cable operators providing
regulating cable services is 16.16%. We propose to adjust the figures
used to estimate the equity cost periodically. We ask comment on this
approach.
9. We also request comment on a method that would, consistent with
the goal of maintaining administrative feasibility, adjust the equity
cost to reflect extraordinary financial risk. For example, should the
Commission consider debt-to-cash flow multiples as a mechanism to
quantify risk levels? We solicit data to establish equity cost figures
above and below the proposed 16.16% average equity cost estimate for
operators with debt burdens significantly above and below the average
in our sample.
C. Cost of Debt
10. The other principal component of the overall cost of capital is
the cost of debt. In the Cost Order, we relied on debt cost estimates
for the cable industry specifically and concluded that the range for
the average cost of fixed rate debt established by information
submitted in the cost of service proceeding was 7.8% to 8.65%. The
Commission noted the substantial proportion of floating rate debt among
cable entities and determined that a cautious estimate would place
average debt cost at 8.5%.
11. We propose to rely on more direct estimates of capital cost by
gauging an operator's debt cost to its actual cost. This debt cost
would encompass fees or other premiums that the operator may pay to
obtain debt financing. We invite comment on this proposal.
D. Capital Structure
12. In the Cost Order, we decided against using embedded capital
structures and market equity values to establish the capital structure
used to calculate the overall rate of return. We indicated that a
capital structure range may be more appropriate for the debt-laden
cable industry and set that range at 40% to 70% debt and used that
range in setting the overall capital cost.
13. We tentatively conclude, however, that actual, i.e.,
individualized, capital structures should be applied to the estimation
of the overall cost of capital. The estimation of debt costs is
relatively straightforward because the cost of debt can be documented
and certified by independent accounting services. Because debt costs
can be measured directly, we tentatively conclude that reliance on the
actual percentage of debt in an operator's capital structure will
ensure the most accurate estimation of interest costs. Thus, if an
operator elected not to rely on the presumptive 11.25% rate of return
in favor of the alternative capital cost measure described in this
Order, we would look to the actual capital structures of the operator
to determine the appropriate overall capital cost.
14. Estimating the amount of equity in an operator's structure is a
complex proposition. Many operators have a negative net worth. We
recognize, however, that, in the case of several publicly-traded cable
companies, the stock of operators with negative book values trades in
significant volumes in the open market. While public utility regulation
has relied traditionally on book value estimations of equity in
determining capital structures for regulated utilities, it may be
appropriate to take note of the equity transactions in the cable
industry that occur frequently, including the decisions of cable
investors to pay multiples of cash flow for cable systems that, based
on book value, should be worth less than nothing.
15. In order to rely on actual capital structures, however, we must
ensure that measurement of the equity proportion filters out a
``premium'' for anticipated gains in unregulated services. As we
consider this alternative, however, we recognize that several issues
must be addressed and resolved. Moreover, we remain committed to an
approach that is administratively feasible. To assist the Commission in
this endeavor, we request comment on the following issues:
a. What mechanism or analysis should guide the Commission in
estimating the equity proportion of an operator's capital structure
that is dedicated to regulated services?
b. How should the Commission estimate the proportion of equity in
an operator's capital structure when that operator is not publicly-
traded?
c. Should the Commission rely on the book value of debt or the
market value of debt in estimating the proportion of debt in an
operator's capital structure?
d. Can the Commission develop a reasonable estimate of an
operator's capital structure by combining the market value of its
equity and the book value of its debt?
e. If market capitalization is used to measure the proportion of
equity in an operator's capital structure, will increases in the
operator's stock price drive up subscriber rates by increasing the
proportion of equity in the operator's capital structure? If so, how
can the Commission ensure that reliance on market capitalization
measures for equity will not unduly impact subscriber rates?
III. Regulatory Flexibility Analysis
16. Pursuant to Section 603 of the Regulatory Flexibility Act, the
Commission has prepared the following initial regulatory flexibility
analysis (``IRFA'') of the expected impact of these proposed policies
and rules on small entities:
The proposals, if adopted, will not have a significant effect on a
substantial number of small entities.
List of Subjects in 47 CFR Part 76
Cable television, Reporting and recordkeeping requirements.
Federal Communications Commission.
William F. Caton,
Acting Secretary.
[FR Doc. 96-5426 Filed 3-7-96; 8:45 am]
BILLING CODE 6712-01-P
Complete official Federal Register PDF
FR Doc. 96-5397 National Emission Standards for Hazardous Air Pollutants for Source Category: Pulp and Paper Production
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9383-9399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5397]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 63
[AP-FRL-5437-6]
RIN 2060-AE04
National Emission Standards for Hazardous Air Pollutants for
Source Category: Pulp and Paper Production
AGENCY: Environmental Protection Agency (EPA).
ACTION: Announcement of availability of supplemental information,
proposed rule, and opening of the public comment period for these
actions.
-----------------------------------------------------------------------
SUMMARY: This action presents an assessment of supplemental information
on 1993 proposed National Emission Standards for Hazardous Air
Pollutants (NESHAP) for the Pulp and Paper Production Source Category
and announces proposed additional sources in that source category not
covered by the 1993 proposed standards. These additional sources
include mechanical mills, secondary fiber mills, nonwood fiber mills,
and paper machines. This action also announces availability of data for
public review that is in addition to data previously announced in a
February 22, 1995 Notice of Data Availability (60 FR 9813). In
addition, this action announces the availability and requests comments
on new emission factors developed using that data.
This action sets forth the most significant changes EPA is
considering, but is not inclusive of all changes likely
[[Page 9384]]
to be made on the 1993 proposed NESHAP. EPA is still considering other
comments submitted on the 1993 proposed NESHAP and will combine them
along with comments and data received on this action to form the basis
for the promulgation of a final NESHAP later this year. Proposed NESHAP
for the chemical recovery area combustion sources at mills are not
contained in this action, but will follow in a separate action later
this year.
DATES: Comments are requested only on information presented in this
action. Comments must be received on or before April 8, 1996, unless a
public hearing is requested by March 18, 1996. If a hearing is
requested, written comments must be received by April 22, 1996.
ADDRESSES: Comments related to the chemical wood pulping mills (kraft,
sulfite, soda, and semi-chemical) should be submitted (in duplicate, if
possible) to: Air Docket Section (6102), Attn: Docket No. A-92-40, U.S.
EPA, 401 M Street, SW, Washington, DC 20460, and Ms. Penny Lassiter,
address shown in FOR FURTHER INFORMATION CONTACT Section. Comments
related to mechanical mills, secondary fiber mills, nonwood mills, and
paper machines should be submitted (in duplicate, if possible) to Air
Docket Section (6102), Attn: Docket No. A-95-31 (MACT III), U.S. EPA,
401 M Street, SW, Washington, DC 20460 and Ms. Elaine Manning, address
shown in FOR FURTHER INFORMATION CONTACT Section.
FOR FURTHER INFORMATION CONTACT: For additional information or
regulations applicable to chemical wood pulping mills, contact Ms.
Penny Lassiter or Mr. Stephen Shedd, Office of Air Quality, Planning,
and Standards (MD-13), U.S. EPA, Research Triangle Park, North Carolina
27711: telephone Ms. Lassiter at (919) 541-5396 or Mr. Shedd at (919)
541-5397. For further information on the regulatory development for
mechanical mills, secondary fiber mills, nonwood mills, and paper
machines, contact Ms. Elaine Manning at the address in Research
Triangle Park listed above, telephone (919) 541-5499, facsimile for the
address in Research Triangle Park listed above is (919) 541-3470.
SUPPLEMENTARY INFORMATION: Public Hearing. Anyone requesting a public
hearing must contact EPA no later than March 18, 1996. If a hearing is
held, it will take place on March 25, 1996, beginning at 9 a.m. at the
EPA Administration Bldg., Main Auditorium, 79 T.W. Alexander Drive,
(near intersection of NC54), Research Triangle Park, NC. Persons
interested in attending the hearing or wishing to present oral
testimony should notify Ms. Jolynn Collins, U.S. EPA, Research Triangle
Park, North Carolina 27711, telephone (919) 541-5671.
Docket. Air Docket No. A-92-40, contains supporting information
used in developing the proposed standards and this action for the
chemical wood pulping mills. All docket cites in this action are from
Air Docket No. A-92-40, unless specified differently. Air Docket No. A-
95-31 contains information that supports the proposed standards for the
rule development for the mechanical mills, secondary fiber mills,
nonwood mills and paper machines. These air dockets are located at the
U.S. Environmental Protection Agency, 401 M Street, SW, Washington, DC
20460 in room M-1500, Waterside Mall (ground floor). All comments
received during the public comment period on the 1993 proposed NESHAP
are contained in the Pulp and Paper Water Docket located in the
basement of Waterside Mall, room L102. These dockets may be inspected
from 8:30 a.m. to 12 p.m. and 1:00 p.m. to 3:00 p.m., Monday through
Friday. A reasonable fee may be charged for copying.
Documents. An electronic version of this action as well as ``Review
Draft: Chemical Pulping Emission Factor Development Document,''
``Presumptive MACT for Non-Chemical and Other Pulp and Paper (MACT III)
Mills,'' and previous Federal Register notices pertinent to the pulp
and paper NESHAP are available for download from EPA's Technology
Transfer Network (TTN), which is a network of electronic bulletin
boards developed and operated by EPA's Office of Air Quality Planning
and Standards. The TTN provides information and technology exchange in
various areas of air pollution control. The service is free, except for
the cost of a phone call. Dial (919) 541-5742 for data transfer of up
to 14,400 bits per second. The TTN is also available on the Internet
(access: TELENET ttnbbs.rtpnc.epa.gov). For more information on the
operation of the TTN, contact the systems operator at (919) 541-5384.
The information in this action is organized as follows:
I. Background
A. History
B. Summary of Action
C. New Data
D. Public Participation
II. Source Category and Pollutants for Control
III. Emission Factors
IV. Definition of Source
V. Subcategorization
VI. Level of Standards
A. Kraft
B. Sulfite
C. Semi-Chemical
D. Soda
E. Bleaching
VII. Compliance Extension for Kraft Mills
VIII. Emission Averaging
IX. Relationship with Other Rules
A. New Source Review/Prevention of Significant Deterioration
Applicability
B. Boiler/Industrial Furnace/Resource Conservation and Recovery
Act Applicability
C. Kraft New Source Performance Standards
X. Standard for Nonchemical Pulp Mills
A. Presumptive MACT Process
B. Summary of the Presumptive MACT for MACT II Sources
C. Area/Major Source Discussion
D. Proposed MACT III
E. Request for Information
I. Background
A. History
The Clean Air Act (the Act) requires EPA to develop NESHAP for the
pulp and paper source category by November 1997. Under section 112 (d)
of the Act, the goal of NESHAP is to require the implementation of
maximum achievable control technology (MACT) to reduce emissions and,
therefore, reduce the public health hazard of pollutants emitted from
stationary sources.
On December 17, 1993 (58 FR 66078), EPA published proposed NESHAP
and effluent guidelines for the pulp and paper industry. These
integrated regulations are referred to as the cluster rule. The purpose
of this action is to announce the availability of additional data and
to reopen the public comment period only for items identified in this
action. EPA's Office of Water (OW) plans to issue a Federal Register
notice similar to this action for the effluent guidelines portion of
the cluster rule. Publication of OW's action is anticipated to be in
approximately four weeks.
The 1993 proposed air standards would regulate all HAP's emitted
from new and existing pulp and paper mills that chemically pulp wood
fiber using kraft, sulfite, soda, or semi-chemical methods (MACT I).
These proposed MACT I standards address air emission points in the
pulping and bleaching processes and in the associated process
wastewater collection and treatment systems. Information was not
available at that time to evaluate controls on other emission points
within the source category. The standards for the pulp and paper source
category, therefore, are being developed in phases. Standards for
combustion sources (MACT II) are under development and will be proposed
later this year. Proposed standards for the remaining sources
[[Page 9385]]
(MACT III) are addressed in Section X of this notice. The MACT III
standards apply to the following operations located at all mills:
mechanical pulping (e.g., groundwood, thermomechanical, pressurized);
pulping of secondary fibers (deinked and nondeinked) by nonchemical
means; nonwood pulping; and paper machine additives. Coating and
converting operations will be addressed later under a separate source
category.
Available data shows that pulp and paper facilities emit
significant quantities of HAP's that would be controlled by the
proposed standards. Some of these pollutants are considered to be
carcinogenic, and all can cause toxic health effects following
exposure, including nausea, headaches, respiratory distress, and
possible reproductive effects. Most of the organic HAP's emitted from
this industry also are classified as volatile organic compounds (VOC)
which participate in photochemical reactions in the atmosphere to
produce ozone, a contributor to photochemical smog. The proposed
emission controls for HAP's will reduce VOC emissions as well. The
proposed HAP control technologies will similarly reduce emissions of
total reduced sulfur (TRS) compounds that are of concern because they
produce some odor and they include some HAP.
The public comment period on the proposed NESHAP ended on April 18,
1994; however, EPA recognized in the preamble to the proposed rule that
various industry groups were collecting air emissions data that would
not be available until after the comment period and further stated that
EPA would still consider those data before the promulgation of the
NESHAP. Some of the data were received and were noticed in a February
22, 1995 Notice of Data Availability (60 FR 9813).
This action announces the availability of new data and solicits
comments on the use of the data for emission factor development and on
changes to the proposed rule. These data and analyses are included in
Air Docket A-92-40. This action does not reopen the public comment
period for all issues related to the proposed rule. Comments should
address only those technical and regulatory changes specifically
mentioned in this action.
On September 29, 1995, a Presumptive MACT report was issued for the
MACT III source category. A brief description of the Presumptive MACT
process and the outcome of the process is provided in Section X.
Comments are also solicited on the MACT III tentative conclusions. EPA
currently plans to take final action on the MACT III NESHAP for the
sources discussed in this action at the same time as the MACT I final
action. EPA also plans to propose NESHAP for recovery area combustion
sources (MACT II) at the same time.
B. Summary of Action
As noted earlier, EPA has proposed NESHAP for mills that chemically
pulp wood fiber. EPA is considering revisions to this proposed NESHAP
based on comments from the public as well as test data that has been
given to EPA since proposal. The changes to the proposed rule under
consideration include: revisions to emission factors; broadening of the
source definition; development of subcategories for pulping; revisions
to MACT requirements and how they are applied; and revisions to MACT
compliance schedule for certain kraft mill emission points. This action
also identifies how EPA currently plans to address concerns raised by
commentors regarding interaction between the NESHAP, currently under
development and other rules, such as Resource Conservation and Recovery
Act/Boiler Industrial Furnace (RCRA/BIF) and Prevention of Significant
Deterioration/New Source Review (PSD/NSR). EPA is also soliciting
comments on the industry's alternative compliance concept that includes
some degree of emissions averaging. A brief overview of these changes
is described below. The data and information to support these changes
under consideration can be found in the Air Docket No. A-92-40.
Additionally, EPA is announcing a proposed decision for standards for
other mills and paper machines.
The emission factors were evaluated using additional emission test
data submitted by the industry. Also, the approach to emission factor
development has changed since proposal as more information has become
available. The new approach involves developing emission factors for
functional mill systems, as opposed to the individual emission points
used at proposal. This emission factor evaluation is contained in a
development document and is being announced in this notice for public
review and comment.
At proposal, EPA chose a single source definition to include
pulping processes, bleaching processes, and pulping and bleaching
wastewater streams at a pulp and paper mill. EPA currently intends to
expand this definition to include paper machines and the causticizing
area due to the interrelated nature of these processes with the pulping
and bleaching areas.
At this time, EPA plans to subcategorize the pulping and associated
wastewater components to develop different MACT requirements. This
subcategorization is necessary to reflect important differences between
the different pulping process emissions, emission controls, and control
cost. The pulping (and associated wastewater) subcategories being
considered are kraft, sulfite, soda, and semi-chemical.
At proposal, all vents and pulping wastewater streams in pulping
and bleaching areas were subject as a group to the MACT requirements
with the exception of certain small vents and wastewater streams
defined by numerical cutoffs. For existing source MACT applicable to
the pulping component at kraft mills, EPA is considering specifically
defining the following systems as requiring enclosure and venting to a
control device: the low volume-high concentration (LVHC) vent system
(i.e., the digester, turpentine recovery, and evaporator systems); weak
black liquor storage tanks; the pre-washer knotting and screening
system; the brownstock washing system; and the oxygen delignification
system. Enclosure and vent control requirements would not change from
proposal. Only these enumerated systems would be subject to the rule.
EPA currently intends to define new source MACT for the pulping
area at kraft mills to be the same as existing source MACT with the
addition of control of post-washer deckers and screens. EPA currently
intends to define new and existing source MACT for kraft mill
wastewater to be collection and treatment of certain named pulping
condensate streams instead of all pulping wastewater above 500 parts
per million by weight (ppmw). EPA is considering changing the proposed
treatment requirements for steam strippers at kraft mills to allow
compliance with one of the following: (1) Removal of 92 percent of the
HAP or methanol content, (2) removal of 9.2 pounds of methanol per air-
dried ton of pulp (lb/ADTP), or (3) treat to a steam stripper outlet
HAP concentration below 330 ppmw measured as methanol. For unbleached
kraft mills, the following treatment requirements would be applicable:
(1) Removal of 92 percent of the HAP or methanol content; (2) removal
of 5.9 lb/ADTP of methanol; or (3) treatment to a steam stripper outlet
HAP concentration below 210 ppmw measured as methanol. As at proposal,
methanol is being used here as a surrogate for tracking total HAP
reduced. Mills still have the option of achieving these removals with
an
[[Page 9386]]
alternative control device, recycling to a controlled system, or
hardpiping these condensate streams directly to the biological
wastewater treatment plant instead of steam stripping.
EPA is considering extending the compliance time for controlling
brownstock washers and oxygen delignification units for kraft pulping
mills by an additional 5 years. The additional period would be provided
to allow industry sufficient time to plan, coordinate, and implement
the best combination of control technologies that facilitate pollution
prevention and emphasize the multimedia nature of pollution control.
EPA is considering the following standards for the newly-created
sulfite, semi-chemical, and soda mill subcategories. Based on an
analysis of current controls, EPA is considering requiring certain
sulfite mill vents in the pulping component at existing sources (i.e.,
digester, evaporator, and red stock washers) to be vented to recovery
systems to reduce HAP emissions. Affected vents at new sources include
the same vents as at existing sources, with the addition of knotter and
screening systems, and weak and strong liquor and acid condensate
storage tank vents. Air emissions from these selected vents and
connected recovery systems would be limited to certain mass emission
rates or percent reductions across the complete connected system. This
systems approach would allow many mills to use the various
configurations of current recovery systems to meet either of these
limits. Compliance would be demonstrated by an initial performance test
to confirm compliance with one of the mass limits, followed by
monitoring of control and process equipment operating parameters to
demonstrate long-term compliance. EPA has determined from an evaluation
of the current mill emission data that the following emission values
represent the best performing existing and new mills: (1) Mass emission
rates of 0.65 and 1.10 lb methanol/ODTP, or (2) a mass HAP or methanol
emission reduction of 92 and 87 percent, for calcium-based and ammonium
and magnesium-based mills, respectively. The new and existing MACT for
pulping wastewater streams at sulfite mills would be no additional
control.
EPA currently plans to define existing source MACT for semi-
chemical mills and soda mills to be enclosure and venting of LVHC vents
to a control device. Enclosure and control device requirements would be
the same as at proposal. New source MACT for semi-chemical and soda
mills would be the same as existing source MACT plus the control of the
washer system vents. The new and existing MACT for pulping wastewater
streams at semi-chemical and soda mills is no additional control.
For bleaching processes at all mills, EPA is still considering
requiring all vents from the bleaching stages which utilize chlorine
and/or chlorine dioxide to control emissions of chlorinated HAP's by 99
percent from the tower, seal tank, and washer vents as in the proposed
NESHAP. A new limit of 10 parts per million by volume (ppmv) of
chlorinated HAP from the outlet of the scrubber is also now being
considered as an alternative to the 99 percent removal limit. A mill
would still be allowed to measure the chlorinated HAP's as chlorine.
Additionally paper-grade bleaching processes would be required to
control chloroform air emissions by complying with the Best Available
Technology (BAT) economically achievable currently under development by
EPA's OW. EPA is still re-considering the level of control for
chloroform from bleach plants at dissolving-grade mills. MACT for new
sources would be the same as MACT for existing sources. The proposed
requirements for controlling methanol and other organic HAP emissions
for bleaching stages will likely no longer be considered. As at
proposal, MACT for bleaching wastewater would be no additional control.
EPA has responded to requests for guidance on the interaction and
applicability of the proposed air regulation with RCRA/BIF and NSR/PSD.
With regard to the possible interaction of the regulation with RCRA/BIF
that could result from the combustion of concentrated condensates
derived from steam stripper overhead vents, EPA has initially
determined that regulation of combustion of these condensates under
RCRA is unnecessary because the MACT controls would be protective. With
regard to the possible interaction of the regulation with NSR/PSD that
could come as a result of secondary emissions from combustion control
devices used to comply with this NESHAP, EPA is considering
recommending to State permitting agencies that mills complying with the
cluster rule be granted the ``pollution control project'' (PCP)
exclusion and be allowed to conduct minor NSR only.
These are the most significant changes to the 1993 proposal that
EPA may implement in the final NESHAP, but they do not include all
changes likely to be made. More detailed information on changes
discussed in this action and supporting documentation can be found in
later sections.
In this action, EPA is also announcing a proposed decision for
standards for mechanical mills, secondary fiber mills, nonwood mills,
and additives and solvents applied to paper machines (MACT III). The
proposal is based on Presumptive MACT that was issued in September
1995.
C. New Data
In the February 22, 1995 Notice of Data Availability (60 FR 9813),
EPA announced data that had been received through February 16, 1995.
These data included three separate multi-volume test reports, several
test report and testing program summaries, and a draft condensate
study. This action announces the availability of new data and solicits
comments on the use of the data for emission factor development and on
changes to the proposed rule.
Data added to Air Docket A-92-40 since the 1993 proposal are
located in Section IV of this docket. Major groups of data of
particular note (but not inclusive of all data in Section IV under
consideration by EPA) are as follows: (1) Items IV-A-4, IV-D1-30, IV-
D1-32, IV-D1-36, IV-J-17, and IV-J-28, supplemental information and
corrections to the data noticed at 60 FR 9813; (2) IV-D1-84 and IV-J-
31, compilation of emissions data noticed at 60 FR 9813; (3) items IV-
D1-27, IV-D1-46, IV-D1-66, IV-D1-75, and IV-D1-79, wastewater system
components, emissions, methanol biodegradability in wastewater
treatment systems, and soluble biological oxygen demand (BOD) as a
parameter to track methanol biodegradability; (4) IV-D1-72, IV-D1-76,
IV-D1-77, IV-D1-80, IV-D1-81, IV-D1-86, IV-D1-89, IV-D1-90, IV-D1-92,
IV-E-64, and IV-E-68, control of air emissions at semi-chemical pulp
mills; (5) IV-D1-87, IV-D1-88, IV-D-93, IV-D1-94, IV-E-31b, IV-E-60,
IV-E-66, and IV-E-67, control of air emissions at sulfite pulp mills;
(6) IV-D1-43, IV-D1-58, IV-D1-62, IV-E-15, IV-E-25, IV-E-28, IV-E-38,
IV-E-45, and IV-J-9, control design and costs; (7) IV-J-29 and IV-J-32,
characterization of pulping condensates; (8) IV-D1-59 and IV-D1-95,
industry's Clean Water Alternative (see Section VIII of this notice);
(9) IV-D1-83, knotter emissions data; and (10) IV-D1-51, IV-D1-56, and
IV-E-63, characterization and control of concentrated steam stripper
condensates.
EPA also requests comments on EPA studies and memoranda completed
since the 1993 proposal and contained in the docket (docket categories
IV-A EPA Studies or Contractor Reports and IV-B EPA Factual Memoranda).
These EPA studies and memoranda include
[[Page 9387]]
the emission factor development document and provide support material
for the Level of the Standards Section VI in this notice.
D. Public Participation
A public comment period was open from December 17, 1993 to April
18, 1994 and a public hearing was held on February 10, 1994 to receive
comments on the 1993 proposal. Comments and data received at the
hearing and during the comment period are included in the docket (see
SUPPLEMENTARY INFORMATION Section). EPA has also held numerous meetings
on the 1993 proposed integrated rules and the Presumptive MACT with
many of the stakeholders from the pulp and paper industry, including a
trade association (American Forest and Paper Association - AF&PA),
numerous individual companies, consultants and vendors, environmental
groups, labor unions, and other interested parties. Materials have been
added to the docket to document these meetings and to make available
for public review new information received at those meetings.
II. Source Category and Pollutants for Control
EPA proposed in 1993 to regulate total HAP emissions from mills
that chemically pulp wood fiber using kraft, sulfite, soda, and semi-
chemical methods. At that time, EPA did not propose to regulate the HAP
emissions from other types of mills. EPA is now inclined to include
into this standard additional types of mills in the pulp and paper
industry as well as the paper machines at all the mills (MACT III).
These new mills include mechanical mills, secondary fiber mills, and
nonwood mills. EPA's current position on these mills and on paper
machines is described in Section X.
The 1993 proposed NESHAP regulates total HAP emissions from
pulping, bleaching, and process wastewater at facilities covered by the
proposal, as opposed to individual HAP's. The proposed standards allow
the use of methanol (or methanol and chlorine from bleaching emissions)
as surrogate compounds because EPA initially concluded that use of
surrogates is technically viable and is a less costly way to track HAP
emission reductions.
For pulping processes and wastewater, EPA's position on pollutants
to be covered has not changed since proposal, and EPA is still inclined
to regulate total HAP emissions, allowing the use of methanol as a
surrogate measurement parameter. At proposal, EPA determined that the
bleach plant emissions were comprised of various chlorinated and
nonchlorinated HAP's. Therefore, a total HAP standard was proposed.
Data at proposal indicated that methanol and chlorine could be used as
surrogates for the nonchlorinated and chlorinated portions of total
HAP, respectively. As a result of comments and data received since
proposal, EPA now knows that only chlorinated HAP's, primarily
chlorine, chloroform, and hydrochloric acid, are being controlled by
the MACT control technologies for bleach plant emissions. Therefore,
EPA currently plans to regulate only the emissions of chlorinated HAP's
from bleaching processes. A more detailed discussion on this topic is
presented in Section VI.
III. Emission Factors
Based on comments and data received, EPA has re-evaluated the
emission factor development approach used to characterize emission
sources and developed new emission factors. EPA developed emission
factors at proposal based on all available data. These data included a
field test program of air and liquid samples from four kraft mills and
one sulfite mill (EPA 5-mill study) and some limited additional
industry data that was used to supplement EPA 5-mill study (see the
Pulp, Paper, and Paperboard Industry Background Information for
Promulgated Standards, Volume 2). Industry representatives commented
that these data were insufficient to accurately characterize emissions
and have since supplied EPA with additional test data from kraft,
sulfite, semi-chemical, and soda mills. EPA analyzed and incorporated
these data into the existing database.
At proposal, EPA developed emission factors for each type of
individual emission point typically found at the mills. Based on the
additional test data, EPA is considering changing that approach. The
new approach involves developing emission factors based on mill systems
rather than on individual emission points. The mill systems are defined
in Section VI, Level of Standards.
EPA now considers this mill system approach the best approach for
several reasons. First, this approach provides a more objective
comparison of the mills. Mills often utilize different configurations
of equipment within a system, making point by point comparisons
misleading. Averaging such pieces of equipment together can provide an
inaccurate estimate of the total system. For example, comparing one
mill's oxygen delignification system as a whole to another mill's
system was more meaningful than establishing separate emission factors
for each piece in the system (e.g., blow tanks, washer units,
interstage storage chests, and filtrate tanks); not all mills have the
same types of equipment in their oxygen delignification system, and
some mills label their oxygen delignification equipment differently.
Next, one mill may have a single screen and another mill may have
multiple screens, but both mills have one screening system with
emissions that can be compared. The mill system approach makes these
kinds of comparisons between mills possible.
Finally, the mill system approach lessens the problems associated
with the nomenclature assigned to each of the components. Variability
exists between the names that different mills assign to similar pieces
of equipment in the same locations. By combining individual emission
points into complete systems, the problem was lessened.
The results and the grouping procedures and approach followed for
each mill system at the various mill types are detailed in the ``Review
Draft: Chemical Pulping Emission Factor Development Document.'' The
report is available in the docket and may be downloaded from the TTN
(see SUPPLEMENTARY INFORMATION Section). This report also discusses the
specific issues and all assumptions that were made in the emission
factor development, including the specific data points tested by
industry that were included in each mill system. EPA is specifically
asking for comments on the results and the approach used in developing
the emission factors before issuing the final report.
IV. Definition of Source
In the December 17, 1993 proposal, three definitions of ``source''
were proposed and considered by EPA. The one chosen by EPA at the time
of proposal was a single source to include the pulping processes, the
bleaching processes, and the pulping and bleaching process wastewater
streams at a pulp and paper mill. EPA is still inclined to use the
single source definition. EPA considers the broad source definition to
be the best interpretation for the pulp and paper industry. This broad
source definition would alleviate concerns that a small change to an
existing mill that creates a small increase in emissions would trigger
new source requirements in the NESHAP. The single source definition is
also the most appropriate interpretation for the industry due to the
interrelated nature of equipment in pulp and paper mills. For example,
wastewater recycling from process to process is an
[[Page 9388]]
integral part of a mill in order to reduce fresh water intake.
Emissions from a piece of process equipment are a function of
pollutants released during the processing of the pulp as well as
pollutants volatilized from water recycled to the process equipment.
EPA is inclined to include paper machines and causticizing
equipment in the source definition above. The term paper machine being
used here does not include paper machine additives and solvents, and
their associated air emissions being addressed in the proposed MACT III
standards set forth in Section X of this notice. Paper machine
emissions discussed here for inclusion in the above source definition
are from the HAP's remaining on the pulp from the pulping and bleaching
process and released when processed through the paper machine. EPA
would include paper machines and causticizing equipment since the
emissions from these sources are, like the emission points discussed
above, interrelated with other process emissions. For example, water is
often reused or recycled from pulping processes to the causticizing
processes, and HAP's in the pulp and water slurry from the pulping and
bleaching processes are carried over into the paper machine where they
are emitted. While the causticizing area and the paper machines were
not defined as part of the source at proposal, they were still being
controlled through the wastewater MACT requirements. Treatment of
condensate streams to remove HAP's prior to recycling them would result
in reduced emissions from the equipment to which they are recycled and
from subsequent pieces of equipment due to reductions in HAP carried
over with the pulp and process waters. EPA recognizes the wastewater
contribution to emissions from these processes and as such currently
intends to include these processes in the source definition. A mill
could then take credit for emission reductions from these processes if
it chose to implement the Clean Water Alternative. The Clean Water
Alternative is discussed further in Section VIII (Emissions Averaging).
EPA considered regulating emissions from woodpiles, but did not
find evidence to suggest that woodpiles are sources of HAP emissions.
Therefore, they are excluded from the definition of source.
V. Subcategorization
In the proposed rule, EPA solicited comment on the need for
subcategories. Many commentors responded to this solicitation with
information on why certain mills should be treated differently than
kraft mills. Separate subcategories for kraft, sulfite, soda, and semi-
chemical pulping processes were suggested. Issues raised by commentors
in support of subcategories included the difference in process
emissions and emission control technologies for sulfite, soda, and
semi-chemical mills. Others indicated that the lack of air and
wastewater emissions data on these types of mills prevented a balanced
assessment of the need for subcategories.
Based on comments received, review of the industry data submitted
after proposal, and meetings with industry groups, EPA solicits comment
on establishing four separate subcategories for the pulping processes
at mills based on the type of pulping process (kraft, sulfite, semi-
chemical, and soda) used.
As a result of the differences in digestion methods, the mills
produce different emissions that have resulted in different degrees of
control at baseline and different applicable control technologies. At
proposal, EPA understood that the four types of mills differ in the way
they digest wood to make pulp, but did not have the data to determine
the extent to which these differences influence potential emission
control strategies. Information received after proposal indicated the
significant extent of these differences.
Kraft mills generate significant quantities of TRS compounds.
Emissions of TRS compounds are regulated under the New Source
Performance Standards for Kraft Mills (kraft NSPS). The vent streams
subject to control also contain HAP's. Therefore, a number of kraft
mills already have a control system in place for the LVHC vent streams.
Also, most kraft mills contain the means of combusting other HAP
containing streams, such as high volume-low concentration (HVLC) vent
streams.
While the HAP-containing vents at kraft mills are laden with TRS
compounds, the HAP containing vents at sulfite mills contain sulfur
dioxide (SO2). Sulfite mills collect the emissions from these
vents to recover the SO2, which is necessary to the production of
the cooking liquor. The collection and burning of these vent streams,
as is typically done at kraft mills, would not be practical. Therefore,
a MACT standard with a different technology basis is needed for these
mills, and a separate subcategory warranted.
Emissions data indicate that soda and semi-chemical mills have HAP
emissions in the same range as for kraft mills, although semi-chemical
mill emissions tend to be at the lower end of the kraft range. However,
these mills do not generate significant quantities of TRS compounds.
Therefore, these mills lack the LVHC equipment already installed at
kraft mills, as well as lacking the benefit of controlled odor from
these vent streams. The digestion process in semi-chemical pulping
differs from soda pulping resulting in different emission points and
characteristics. However, EPA intends to set MACT for the semi-chemical
and soda mills as control of the LVHC vent streams. The MACT
requirements are discussed in Section VI (Level of Standards).
Where two or more subcategories are located at the same mill site
and share a piece of equipment, that piece of equipment would be
considered a part of the subcategory with the more stringent MACT
requirements for that piece of equipment. For example, the foul
condensates from an evaporation set processing both kraft weak black
liquor and spent liquor from a semi-chemical process would have to
comply with the kraft subcategory requirements for foul condensate.
This more stringent requirement is appropriate because there is no
viable way to isolate the emissions for each pulping source to
determine compliance separately.
VI. Level of Standards
Changes from the 1993 proposal now being considered by EPA on the
level of the standard (emission limits and points to be controlled) are
presented in this section. At proposal, sulfite, semi-chemical, and
soda mills were not differentiated from kraft pulping mills and
therefore were subject to the same control requirements as kraft mills.
As discussed earlier, EPA is considering subcategorizing kraft,
sulfite, semi-chemical, and soda pulping and associated wastewater
components for the purpose of setting MACT standards. While EPA does
not currently contemplate subcategorizing among bleaching processes,
EPA may distinguish between papergrade and dissolving grade bleaching
processes for purposes of setting chloroform MACT requirements for
bleach plants. The rationale for this distinction is set forth later in
this section.
EPA is also considering naming specific vents and streams subject
to the standard instead of determining affected emission points and
wastewater streams based on broad groups of equipment with exclusions
for small streams currently not being controlled, as was done at
proposal. This change in approach will more accurately specify the
units that should be controlled.
Requirements for enclosures, closed-vent systems, and control
devices for
[[Page 9389]]
those closed vent systems in the pulping process, as set forth in the
proposed NESHAP, would be the same for the pieces of equipment being
named in this action for kraft, semi-chemical, and soda mills. Public
comments received on these 1993 proposed NESHAP requirements are under
review. EPA will consider these comments prior to promulgation of this
rule and will assess whether changes are warranted; however, such
potential changes are not discussed in this notice. Those same
requirements for enclosures and closed-vent systems, as set forth in
the proposed NESHAP, would also apply to the pieces of equipment being
named in this action for sulfite mills; however, EPA is considering
changing the control device requirements for those closed vent systems
at sulfite mills. Requirements for control of emissions from kraft
pulping wastewater prior to treatment, as set forth in the 1993
proposal, would still apply to the kraft pulping condensate streams
being named in this action; however, EPA is considering changing the
treatment limits for these pulping condensates. No control requirements
are now being considered for non-kraft wastewater streams. Requirements
for enclosures, closed-vent systems, and control devices for those
closed vent systems in the bleaching process, as set forth in the 1993
proposed NESHAP, would be the same for the stages using chlorinated
bleaching agents; however, EPA is considering adding some requirements
for the control of chloroform emissions and is considering adding
additional ways to meet the treatment requirements on the closed vent
systems from the chlorinated bleaching stages. Additionally, EPA is
considering dropping the requirement for control of non-chlorinated
HAP's (methanol, etc.) in the bleaching area.
A. Kraft
This section describes the changes to the level of the standard for
kraft mills from the 1993 proposal. These changes include naming the
streams to be controlled; changing and adding additional performance
levels for steam strippers; and re-evaluating controls for pre-washer
knotter and screen systems, and weak black liquor storage tanks.
The proposed standards required owners or operators of new or
existing sources to enclose and vent all pulping component emission
points into a closed vent system routed to a control device. Deckers
and screens at existing mills and small vents or enclosed process
equipment below certain specified volumetric flow rates, mass flow
rates, and mass loadings were not subject to control. Similarly,
pulping wastewater streams with concentrations below 500 ppmw of HAP's
or flow rates below 1.0 liter per minute (lpm) did not require control.
At proposal, EPA had limited data to characterize some of the
smaller emission points and condensate streams within the pulping
component. However, based upon experience and engineering assumptions,
these small vents and condensate streams were assumed to be
uncontrolled at the floor and not reasonable to control beyond the
floor. Therefore, EPA proposed these low volumetric flow rates and
condensate HAP concentrations to differentiate between points currently
being controlled and those that are not controlled. EPA solicited
comments on whether this was a viable approach for identifying emission
points and condensate streams that should be controlled under the MACT
standard.
Based on comments and data received, EPA re-evaluated the method
for establishing control applicability for pulping process equipment
and associated wastewater streams. Using this new information, EPA is
now tentatively intending to establish control applicability for kraft
pulping process equipment systems and associated wastewater streams by
specifically defining the equipment systems and associated wastewater
streams subject to the MACT standard (i.e., only the equipment systems
and wastewater streams specifically enumerated would be subject to the
standard). EPA believes this change will result in the same level of
control at the MACT floor for both wastewater and process equipment
contemplated in the proposal, yet will reduce or eliminate the cost of
testing that would have been required by the 1993 proposal to determine
applicability. The requirements for enclosures, closed vent systems,
and control devices set forth in the 1993 proposal would still apply.
The named pulping process systems that EPA is considering for
control are: the LVHC vent system, pre-washer knotter and screening
system, the brownstock washing system, weak black liquor storage tanks,
and the oxygen delignification system. The following new definitions
are now under consideration:
1. The LVHC vent system includes batch the digester blow heat
recovery vents, batch digester relief steam condenser vents, continuous
digester relief steam vents, turpentine condenser(s) vents, continuous
digest blow tank vent, evaporator vacuum system vents, liquor
concentrator vacuum system vents, pre-evaporator vacuum system vents,
steam stripper feed tank vents, and steam stripper off gas vents.
2. The brownstock washing system includes rotary vacuum drum
washers, pressure washers, diffusion washers, horizontal belt washers,
all filtrate tanks, and intermediate stock chests. The washing system
does not include deckers, screens, stock chests or pulp storage tanks
following the last stage of brownstock washing.
3. The oxygen delignification system includes the blow tank, the
post oxygen washers, filtrate tanks, and any interstage pulp storage
tanks.
4. The pre-washing screening system includes knotters, knotter
drain tanks, screens, and reject tanks prior to brownstock washing.
At proposal, EPA concluded that a sufficient number of weak black
liquor storage tanks are controlled in the industry to constitute a
floor-level of control. However, several commentors stated that weak
black liquor storage tanks could not feasibly be controlled by simply
venting the tanks to a header system and combustion device (the basis
for the 1993 proposal). The commentors stated that a more complex
system involving sweeping air across the tank would be necessary due to
the potential for an older tank to collapse if a vacuum were pulled on
the tank. A sweep air system would generate a larger volumetric flow
rate from these tanks and thus increase the size of the header and the
combustion capacity required of the control device. An alternative
would be to replace the older tanks with newer tanks which could
withstand the vacuum.
Based on the data available regarding current control technology
levels in the industry and the range of emission potential for these
tanks, EPA believes the 1993 proposed MACT requirements for these tanks
should be retained. However, industry has raised concerns that the
information submitted in the NCASI voluntary survey prior to proposal
is providing a misleading picture of current industry control
practices. The industry has also indicated that the emissions data from
the NCASI test program for these tanks is suspect. The industry is
collecting additional information on current operation, age, emissions,
and control practices for these tanks to supplement information already
provided to EPA.
EPA is considering whether distinguishing between types of weak
black liquor storage tanks is appropriate. Specifically, EPA is
considering the appropriateness of a distinction in age since newer
tanks may be structurally able to withstand a vacuum. EPA is
[[Page 9390]]
interested in any data on the age of the controlled tanks and the types
of controls in use. EPA is also interested in comments on whether age
is an appropriate parameter to consider for determining control
applicability.
Questions remain as to what level of control represents the MACT
floor for these different types of tanks. EPA will continue to discuss
these issues with industry and consider all available information to
resolve the MACT floor questions prior to promulgation.
Several commentors also stated that pre-washer knotter and
screening systems should not be controlled. Based on the data available
regarding current control technology levels in the industry and the
range of emission potential for these systems, EPA believes the control
of pre-washer knotter and screening systems represents a floor-level of
control. However, industry has raised concerns about the information
submitted in the NCASI voluntary survey prior to proposal because the
survey respondents were not clear as to their meaning when they
reported knotter systems as controlled, not controlled, or not vented.
The survey responses also did not indicate if the screening systems
were located before or after washing. Therefore, as with black liquor
tanks, questions remain concerning what level of control represents the
MACT floor for these equipment systems. Industry is collecting
additional information concerning the current operation, emissions,
equipment, and control levels in these systems to supplement the
information already provided. EPA is interested in any additional data
or information concerning the type of and control of emission points in
the knotter and screening systems, both pre and post-washer. EPA will
re-evaluate the MACT floor level of control for these sources prior to
promulgation.
At proposal, EPA characterized pulping wastewater and condensate
streams to be controlled as those with HAP concentrations above 500
ppmw. However, commentors said that the 500 ppmw level was an
inappropriate determinant for wastewater streams controlled at the MACT
floor and provided data to name each stream to be treated. Based on
review of these stream definitions and data submitted by the industry
to characterize these streams, EPA is inclined to agree that the 500
ppmv is inappropriate level and that naming the streams better
identifies the streams to be controlled at the MACT floor. EPA now
considers the subject wastewater streams to be foul condensates and is
inclined to adopt the following definitions of foul condensates and
ancillary equipment:
1. Foul condensates--any liquid streams originating from the
following process areas or equipment: batch digester relief and blow
gas system condensates; batch digester blow heat recovery system
condensates; continuous digester system flash steam condensates;
continuous digester chip steaming vessel condensates; turpentine
decanter underflow; non-condensible gas (NCG) system condensates; NCG
system low point drains; and condensates from the weak liquor feed
stage(s) in the evaporator system. Where vapors or gases from the
digester, turpentine recovery, NCG, and/or evaporator systems are
segregated into low-HAP and high-HAP concentration fractions through
multistage, differential, or selective condensation, only the high-HAP
fraction stream is considered foul condensate. If condensate
segregation is not performed on the process areas or equipment
identified above, the entire volume of condensate generated, produced,
or associated with the process area or equipment shall be considered
foul condensate.
2. Evaporator system--any and all equipment associated with
increasing the solids content of spent cooking liquor including, but
not limited to, pre-evaporators, evaporators (direct and indirect
contact), and concentrators.
3. Condensate segregation--the practice of generating, producing,
or isolating a high-HAP concentration-low flow rate condensate stream
from process vent vapors or gases in order to maximize the HAP mass and
minimize the condensate volume sent to subsequent treatment.
4. Segregated condensate stream (high-HAP fraction)--any condensate
stream that contains at least 65 percent by weight of the total HAP
mass (measured as methanol) that is present in the vapor stream prior
to condensation or isolation.
EPA is requesting comment on this named stream approach and on
whether the definitions shown above and on the pulping process
equipment systems discussed earlier, accurately represent the sources
of emissions to be controlled at the MACT floor and clearly define them
for purposes of compliance determinations.
EPA also re-evaluated control requirements for steam stripping--the
technology on which MACT for these wastewater streams is based. The
proposed standards required that the pulping wastewater streams subject
to control must meet one of the following: Recycle to a controlled
piece of process equipment, reduce the HAP concentration to below 500
ppmw, reduce total HAP or methanol by 90 percent, use the proposed
design steam stripper, or hardpipe the stream to biological treatment.
New performance data on all the currently operated steam strippers were
submitted after proposal (Pulp and Paper Water Docket item 20,027
attachment 3). The new data indicates that the best performing steam
strippers representing the floor level of control achieve a combination
of high percent methanol removal, high methanol mass removal, and low
outlet methanol concentration. Because methanol is a good indicator of
total HAP removal for pulping processes and associated wastewater, any
one of these parameters demonstrates that total HAP are being removed
from the condensate streams and therefore are not emitted to the
atmosphere. Based on that data, EPA now considers that mass removal and
outlet concentration are valid parameters to set control limits in
addition to percent removal as at proposal. The rule would allow mills
to: (1) Choose any wastewater treatment device as long as the device
achieves one of the three parameters and as long as the wastewater is
conveyed to the treatment device in an enclosed conveyance system; or
(2) recycle the wastewater streams to a piece of equipment meeting the
control requirements presented below.
EPA has evaluated the data in the NCASI condensate study (docket
item IV-J-32) and agrees with industry that bleached kraft mills
generate more HAP in pulping wastewaters than unbleached kraft mills
primarily because bleached kraft mills tend to digest the pulp longer.
While unbleached kraft mills can achieve the same percent methanol
removed as bleached kraft mills, unbleached kraft mills cannot attain
the same mass removed or outlet concentration as bleached mills.
Therefore, EPA currently intends to distinguish between bleached and
unbleached mills for the purpose of setting MACT level of control for
pulping wastewater.
The new industry data on steam stripping technologies indicates
that the MACT floor level of control for pulping wastewater at both
bleached and unbleached kraft mills is treating the foul condensate
wastewater streams to remove 92 percent of the HAP content (measured as
methanol). The data indicates that steam strippers achieving the 92
percent control also achieve an equivalent outlet concentration of less
than 330 and 210 ppmw measured as methanol, or remove 9.2 and 5.9
pounds of methanol/ADTP across the treatment
[[Page 9391]]
device, respectively for bleached and unbleached wastewater streams.
Mills would be allowed to use one of three equivalent limits to show
compliance.
EPA still intends to keep the provisions for recycling to enclosed
equipment and hardpiping foul condensates to a mill's biological
wastewater treatment plant. EPA is considering soluble BOD as a
compliance parameter alternative for biological treatment compliance
(docket items IV-D1-27, IV-D1-75, IV-D1-79, and IV-E-44). EPA is
interested in any comments concerning this compliance approach. EPA is
also re-considering the need for a design steam stripper.
New source MACT requirements have not changed since proposal. MACT
for new sources is based on the best level of control achieved from
similar sources. In other words, this technology was selected because
it is used by the best controlled similar source, as required by
section 112 (d) (3). The best controlled similar sources have the same
level of control as existing sources. In addition, the best controlled
source also controls deckers and post washer screen systems by not
venting or enclosing and routing vents to a control device.
B. Sulfite
The level of control for the sulfite industry in the December 17,
1993 proposal was the same as for all mill types (see previous
discussion on kraft mills). This section explains the level of the
standard under consideration for the projected sulfite subcategory. In
summary, EPA has reviewed what sources are being controlled, the
performance of the control technologies, and options for implementation
and setting emission standards for the sulfite industry.
EPA has reviewed public comments and industry data to evaluate the
emission sources controlled at the best performing mills for HAP
reductions. Pulping area sources controlled at the best performing
existing mills are the digesters, evaporators, and red stock washer
system vents (later referred to as the ``selected vents''). These
sources are the same vents as proposed except that knotters or deckers
which follow washers in the sulfite mills are now excluded from control
for existing sources because they are not part of the MACT floor.
Additionally, control of pulping wastewater with steam strippers has
been dropped from consideration since sulfite mills do not employ
stream strippers.
Many public comments stated that the control technology basis of
the standard for sulfite mills should not be combustion as proposed,
since very few mills combust emissions from the selected vents. The
data clearly indicate which emission sources are being collected and
vented to reduce or capture and recover SO2 emissions, which in
turn reduces HAP emissions by some degree. Sulfite mills use a
combination of the acid plant and separate scrubbing systems (e.g.,
nuisance scrubbers) to control and capture SO2 emissions. EPA and
industry have been meeting, collecting, and analyzing data to determine
the degree of HAP emission reduction achieved in these control devices
or systems designed to collect SO2 emissions. Recently, NCASI
provided a summary of the available industry emissions data and
American Forest and Paper Association (AF&PA) made recommendations to
EPA on the MACT standards for sulfite mills (docket items IV-D1-87, IV-
D1-88, and IV-D1-94). In summary, AF&PA recommended that certain named
air emission sources be vented to existing SO2 recovery systems
and that ammonium- and magnesium-based sulfite mills could not recycle
condensates with annual average methanol concentrations exceeding 500
ppmw to pulping and chemical recovery equipment unless the equipment
was being vented to an SO2 recovery device or unless the total
emissions from the all pulping and chemical recovery equipment do not
exceed 2.5 pounds methanol per ton of oven-dried pulp (lb/ODTP).
EPA has used the concept of naming both the sources to be
controlled and the control device on all the other pulping
subcategories. However, for those other subcategories, the named
controls are well understood and emission reduction performance was
well documented. Named control devices for the other subcategories were
specified to meet either a known percent reduction standard, equipment
design standard (e.g., 98 percent control or operate at 1600 degrees
Fahrenheit and 0.75 second residence time for incinerators), or the
named control device is known to operate in a manner to destroy the
emissions to a certain level (i.e., venting to lime kilns or recovery
boilers reduces emissions by at least 98 percent due to very high
operating temperatures). However, for SO2 recovery devices or
systems at sulfite mills there are many combinations of systems used
with various desired SO2 capture efficiencies. Some of these
systems have been shown to be better than others in reducing HAP
emissions. Therefore, simply naming existing SO2 control systems
as the HAP control device does not set a known HAP level of performance
for sulfite mills. EPA must evaluate and set the HAP emission limits
achieved by the best performing existing sources (in this case, the
best performing five mills since there are less than 30 sources
(section 112(d)(3))).
For this evaluation, EPA considered various types of performance
measurement standards for the sulfite industry. Options include
equipment and work practice standards, percent reduction standards,
and/or emission limit (concentration or mass) standards for each or a
combination of streams. As discussed earlier an equipment and work
practice standard is not appropriate. Also, EPA considers that using a
standard that combines emission streams instead of setting individual
stream limits provides the best fit, least expensive, and most flexible
standard since existing mills already use various combinations of
SO2 control technologies for different and varying types of
emission streams. Thus, a mill could use any combination of controls
plus add-on controls or process changes that best fit the existing
facility to get the same emission reduction. EPA evaluated percent
reduction and emission limit standards and found that limits could be
set, based on the best available information. The discussion on how
those limits were determined is found later in this section.
Based on EPA's review of the quantity and quality of data and the
variability in the industry, EPA does not intend to set these limits as
continuous emission limits. Rather, EPA intends that several initial
performance tests be performed using the average of three one-hour
tests when the mill is operating under normal operating conditions to
determine if the control system meets the emission standard. During the
performance test, process and control equipment parameters will be
required to be monitored and matched with the emission limits to
determine the operating and monitoring conditions to be monitored for
long-term compliance with the standard. EPA has used this approach on
other standards to provide flexibility in process operation while
assuring compliance.
Under this program, the owner or operator of the source will
recommend and demonstrate to the permitting authority the appropriate
equipment parameters to be monitored, and the allowable range for those
parameters to demonstrate compliance with the emission standard. This
recommendation would include the data collected during the performance
test supplemented by engineering
[[Page 9392]]
assessments and equipment manufacturer's recommendations. The source
would not be out of compliance with the standard when the source
operates outside those operating conditions if the source reports
(prior to any EPA compliance or enforcement action) and documents that
the episode is during a start-up, shut down, or malfunction as defined
in section 63.2 of the General Provisions. And, the source must
demonstrate that conditions have changed and a retest of the initial
performance test shows compliance with the emission standard.
EPA is considering establishing two emission limit strategies to
demonstrate compliance: mass balance and percent reduction of the
selected vents. Since only methanol data was available for determining
either standard, methanol would be used in this case as a surrogate for
total or individual HAP emission standards. From the recent NCASI
summary of sulfite data, it is clear that calcium-based sulfite mills
have lower emissions because they do not have the extensive recovery
system that ammonium and magnesium-based mills require. Therefore,
emission standards for calcium-based mills will be considered
separately from ammonium and magnesium-based mills.
Section 112 of the Act requires EPA to establish limits based on at
least the average of the five best controlled mills when there are less
than 30 mills. The data set available to EPA to set a mass limit and
percent reduction limit is limited; however the available data
indicates that the average of the three existing calcium-based mills
emit a total of 0.02 lb methanol/ODTP from vents where the selected
sulfite vent emissions are collected and processed. The data set
indicates that the average emissions from the top five ammonium-based
and magnesium-based mills are a total of 0.45 lb methanol/ODTP from the
vents where the selected sulfite vents are collected and processed.
Additionally, the total of the selected vent emissions does not account
for the total air emissions from these systems since scrubbers are used
in the SO2 recovery systems. The scrubbers transfer some of the
HAP from the vents to wastewater that is subsequently sewered. Air
emissions from the sewered recovery system wastewater occur in the
mill's open wastewater collection and processing equipment due to
volatilization. These air emissions from wastewater can be calculated
using EPA's WATER8 Emission Model available on the TTN (under Chief
BBS, Emission Estimation Software, file: water8.zip).
EPA reviewed all the sulfite wastewater data available and the
amount volatilized from an average wastewater system (calculated to be
6 percent lost for methanol using WATER8) and estimates that an average
sulfite mill emits 0.63 lb methanol/ODTP. Estimates from industry
provided earlier in the year also indicated similar results. Industry
has agreed to provide details on sulfite mill wastewater collection and
treatment systems to better estimate the emissions from those systems
since wastewater emissions may be a significant portion of the total
HAP mass emission rate. The total average mass emissions from the
selected sulfite mill vent control systems at the best performing mills
(including vents and wastewater air emissions) are estimated to be 0.65
and 1.10 lb methanol/ODTP for calcium-based and ammonium and magnesium-
based mills, respectively. Using the appropriate value, a mill could
then achieve the emissions reduction under this total mass emission
standard across the selected vents, and the connected recovery system
vent and wastewater emissions.
As noted earlier, industry recommended a much higher vent mass
emission limit of 2.5 lb methanol/ODTP in the industry's sulfite mill
recommendation on limits for recycling wastewater. Industry
representatives stated that the 2.5 lb methanol/ODTP estimate was
derived from the same data set and they derived a similar estimate as
the 0.45 lb methanol/ODTP value discussed above. However, the industry
representatives increased the value (from 0.45 to 2.5) to take into
account variability of testing procedures, mill operating conditions,
and the types of products produced. Industry is currently documenting
their variability calculations and rationale and providing it to EPA
and the rulemaking docket. EPA currently believes that the approach
discussed earlier for implementing these emission limits will
adequately account for variability. However, EPA will consider the
industry rationale and data.
EPA does not have data to support or deny the industry's 500 ppmw
recommendation. Industry is recommending condensate streams exceeding
500 ppmw of methanol should not be allowed to be used/recycled in the
pulping or chemical recovery area to process equipment vented directly
to the atmosphere unless it meets 2.5 lb methanol/ODTP. EPA requests
data and comments on this approach.
The second emission limit approach under consideration for sulfite
mills is setting a mass reduction of HAP emissions from the applicable
emission points. Industry tested two SO2 nuisance scrubbers and
found that while one reduced vent emissions of methanol by 95 percent
and emissions of total HAP by 94 percent, the other SO2 scrubber
increased HAP emissions. Since nuisance scrubbers are only one part of
the recovery system for most mills, the scrubber efficiency alone does
not represent what the total system is controlling. A second approach
was developed that used the mass emission limit derived above and data
on the amount of methanol generated. An industry engineering estimate
indicates that between 15 and 20 lb methanol/ODTP generated in the
sulfite process. Of the amount generated, as much as 8 lbs methanol/
ODTP may be emitted from the selected vents as shown in the recent
NCASI summary of sulfite data. Comparing this amount to the mass
emission rates (0.65 and 1.1 lbs methanol/ODTP) discussed above at the
best performing mills, 92 and 87 percent of the methanol is removed
across the total selected sulfite mill vent control system for calcium-
based and ammonium and magnesium-based mills, respectively. In
conclusion, mills would have to meet either the mass emission or the
mass percent reduction standard across their control system to be in
compliance.
Industry has indicated concern over the numerical mass limits and
percent reductions discussed in this notice because they are based on a
limited data set and because HAP reductions resulting from control
devices installed originally for SO2 control is not well
understood. EPA will review and consider additional data being
collected by this industry and other public commentors to set a HAP
level of performance for sulfite mills prior to promulgation and will
adjust these numerical values as necessary. EPA solicits comments on
the two emission limit strategies for sulfite mills discussed above and
solicits comments on the appropriate numerical values for these
strategies.
New source MACT is based on the best level of control achieved at
baseline. The data shows the best controlled sulfite mills control the
same emission sources as the requirements for existing sources and also
control weak or spent liquor tanks, strong liquor storage tanks, and
acid condensate storage tanks. The best sulfite mills also have non-
venting knotter and screening systems. Therefore, new source MACT is
the same as existing source MACT, as well as, the control of the
aforementioned storage tanks and the
[[Page 9393]]
installation of non-venting knotter and screening systems. EPA
currently plans to require new sources to meet the same mass emission
limit or percent reduction as discussed for existing sources.
C. Semi-chemical
The proposed standards did not differentiate between pulping types;
therefore, the owners or operators of new or existing semi-chemical
mill sources were required to comply with the same standards as kraft
pulping. EPA is considering changing the MACT requirements for semi-
chemical mills to be the control of LVHC vents only (as defined in
section VI.A). Data show that the MACT floor level of control at semi-
chemical mills is collecting LVHC vent emissions and reducing emissions
to the same level as previously proposed in 1993 and discussed earlier
in this notice for kraft mills.
EPA considered whether it would be appropriate to go beyond the
MACT floor at semi-chemical mills to control some of the additional
larger emitting process systems, such as pulp washer systems, that
would be controlled at kraft mills. However, data indicates that
emissions from semi-chemical mills are generally much less than at
kraft mills. Therefore, considering the smaller emission reduction and
the costs to control units beyond the floor, EPA is inclined to set
MACT for semi-chemical mills at the floor (controlling LVHC vent
emissions).
In evaluating the information and through discussions with
representatives from semi-chemical mills, EPA is aware that the best
controlled mills collecting and controlling LVHC vents tend to be
collocated with kraft mills. EPA considered whether a distinction
between collocated and stand-alone semi-chemical mills should be made
for the purpose of setting MACT requirements. EPA determined that there
is no difference in the nature of the vents being collected, and the
level of control is technically feasible and can be achieved at a
reasonable cost; therefore, there is no need to distinguish between
these types of mills. EPA estimates that the control of the LVHC vents
at a typical semi-chemical mill will reduce emissions by 160 Mg of HAP
per year and 1,700 Mg of VOC per year; the cost-effectiveness for a
typical stand-alone semi-chemical mill will range from $1,000 to
$3,000/Mg of HAP. Industry cost estimates fall within that range
(docket item IV-D1-62, IV-D1-86, IV-D1-89, IV-D1-90, and IV-D1-92).
Semi-chemical mill representatives also believe the control of LVHC
vents is a reasonable level of control for stand-alone mills as well
(docket item IV-D1-72 and IV-E-68). Therefore, EPA now considers the
control of the LVHC vents at both types of mills to be MACT and a
distinction is not warranted.
The MACT level of control for HAP emissions from semi-chemical mill
wastewater is no control. EPA is not aware of any semi-chemical mills
treating process wastewaters with steam strippers as is found in the
kraft industry. Since semi-chemical mills generate less HAP than the
kraft process, and therefore, lower HAP-containing streams, EPA does
not consider going beyond the floor to control semi-chemical wastewater
streams to be appropriate.
New source MACT is based on the best level of control at similar
sources. Data indicate the best controlled semi-chemical mills combust
the same LVHC emissions plus the pulp washing system emissions. EPA
anticipates the trend in industry will be to install washer systems
with lower flow rates. This in turn allows for less expensive control
systems. The costs are also reduced at new sources since the controls
can be considered and planned into new equipment installation as
opposed to retrofitted.
Therefore, new source MACT would be the same as existing source
MACT plus the control of the pulp washing systems. EPA has not had a
recent opportunity to discuss this contemplated new source control
level with the affected mills and public and solicits comments and data
on the appropriate levels of control for new sources at these mills.
D. Soda
As discussed previously in section V, subcategorization, EPA
currently plans to establish separate MACT standards for soda mills.
Based on information and data obtained since proposal, EPA now
considers the control of LVHC vents (as defined in section VI. A) at
these mills to be MACT.
Data available to EPA indicate that soda mills do not currently
control any of the equipment that is subject to the MACT requirements
for kraft mills. However, EPA has determined that the emissions from
soda mills are similar to kraft mills and the control costs are similar
to stand-alone semi-chemical mills. Therefore, EPA considers going
beyond the floor to control LVHC vent emissions at soda mills to be an
appropriate level of control for MACT for these mills, taking into
consideration the costs of achieving the controls as well as the other
factors enumerated in section 112(d)(2). EPA estimates that control of
the soda mill LVHC system vents, at a typical mill, will reduce
emissions by 130 Mg of HAP per year and 1,500 Mg of VOC per year.
Data show that no soda mills currently practice steam stripping to
control HAP's in wastewater. EPA initially does not believe the costs
of control of these streams to be warranted, within the meaning of
section 112(d)(2). Therefore, the MACT for the control of HAP in
wastewater would be no control.
The new source requirements are based on the best level of control
at similar sources. Data show that no soda mills are currently
practicing any level of HAP control. However, the control of washing
systems is demonstrated at similar sources (i.e., semi-chemical and
kraft washing systems). Therefore, as discussed in section VI.C for
semi-chemical mills, EPA now considers the control of washing systems
for new sources to be part of MACT. Therefore, new source MAC
FR Doc. 96-5397 National Emission Standards for Hazardous Air Pollutants for Source Category: Pulp and Paper Production
T for soda
mills would be the same as new source MACT for semi-chemical mills
(LVHC and washing system controls). EPA has not had a recent
opportunity to discuss these contemplated new and existing source
control levels with the affected mills and public, and solicits
comments and data on the appropriate levels of control at these mills.
E. Bleaching
EPA is considering changing the proposed MACT requirements for
bleach plants. EPA is also considering making a distinction between
requirements for papergrade versus dissolving grade mills. Changes to
the proposed MACT standard would include only requiring controls for
chlorinated HAP's. The control requirements to achieve chloroform
reductions would be based on a combination of compliance with the
future BAT requirements imposed under the Clean Water Act (only for
papergrade bleach mills) and the enclosure of all bleaching equipment
and routing the vents to a scrubber for all bleach stages where
chlorinated bleaching agents are introduced to control the other
chlorinated HAP's (at all bleach mills). As at proposal, a mill would
be allowed to use chlorine as a surrogate for compliance with these
other chlorinated HAP's around the scrubber. Control of non-chlorinated
HAP's (with methanol as a surrogate), as required at proposal, would be
dropped because data indicate that the best controlled mills do not, in
fact, achieve control of these pollutants. The rationale for these
changes under consideration is set forth below.
[[Page 9394]]
The proposed standards require owners or operators of new or
existing sources to enclose and vent all bleaching component emission
points into a closed vent system routed to a control device. The
proposed MACT was based on caustic scrubbing as the control device.
Vents or enclosed process equipment with volumetric flow rates or total
HAP concentration below certain specified limits were not subject to
control. EPA requested comment on whether MACT should also include
process changes and if a separate MACT standard for chloroform is
appropriate. Based on data received, EPA now considers the chlorinated
HAP limit to be based on the emissions reduction achieved using a
combination of scrubbing and process modifications. Therefore, EPA is
considering setting a MACT standard for both chloroform and other
chlorinated HAP's (chlorine as a surrogate).
Industry provided data for existing bleach plant emission estimates
and scrubber efficiencies. The data clearly indicates that mills
practice significant control of chlorine and chlorine dioxide through
the use of caustic scrubbing (docket item II-I-24). However, existing
bleach plant scrubbers are operated with high recirculation rates which
result in no removal for methanol and other organic HAP compounds
(docket item IV-D1-34). The data also shows reduced chloroform and
other chlorinated HAP emissions with process changes (docket item II-I-
10); however, the data indicate that there are no significant increases
in non-chlorinated HAP emissions. Therefore, EPA currently plans to
drop the total HAP percent reduction limit for methanol and other
nonclorinated organic HAP's.
As discussed earlier, EPA is evaluating two types of bleaching
processes; the distinction is necessary for the purpose of setting
standards for chloroform. These two types of processes are papergrade
bleaching and dissolving grade bleaching, to be defined the effluent
guidelines portion of the cluster rule. The average emission limitation
of the best controlled papergrade bleaching processes result from
control of chloroform and the other chlorinated HAP emissions through a
combination of caustic scrubbing, high levels of chorine dioxide
substitution, and eliminating the use of hypochlorite. The average
emission limitation of the best controlled dissolving grade bleaching
processes also control emissions of the other chlorinated HAP through
caustic scrubbing but tend to use hypochlorite and lower levels of
chlorine dioxide substitution. Therefore at this time, EPA has been
unable to identify the appropriate process modifications for which to
base the chloroform emission control level.
EPA's Office of Water (OW) is currently planning to revise its
technology basis for limits based on results of ongoing studies by
dissolving mills of alternative process technologies different from
those which served as the proposed effluent guidelines. Significant
objectives of these studies include the extent to which hypochlorite
use can be reduced and chlorine dioxide substitution increased in order
to reduce generation and release of chlorinated organic pollutants,
such as chloroform, while maintaining dissolving pulp properties
acceptable to end users of these pulps. When data for these studies
become available, EPA will revise its proposed effluent limitations and
BAT technology option as appropriate, and evaluate data to set
chloroform MACT standards for dissolving grade mills. EPA is interested
in any data concerning chloroform emissions from dissolving grade
bleaching processes and requests comment on an appropriate chloroform
MACT for new or existing dissolving-grade bleach plants.
As proposed, emissions of the other chlorinated HAP (or chlorine as
a surrogate) are to be reduced by 99 percent. EPA is considering also
allowing mills to meet an outlet concentration below 10 parts per
million by volume (ppmv) of HAP from the scrubber exhaust as an
alternative to the 99 percent reduction standard. Commentors asked for
an alternative level to the 99 percent reduction standard because high
substitution rates reduce the bleach vent emissions to the extent that
99 percent reduction across the scrubber is not attainable. Based on
the review of data, the 10 ppmv standard is considered equivalent to
the outlet of scrubbers achieving 99 percent removal (docket item II-I-
24). EPA also is considering whether a mass limit on the scrubber
exhaust would be an appropriate equivalent alternative, and solicits
comment and data on the need and appropriate level for a mass limit.
For papergrade bleaching processes, compliance with OW's BAT option
for papergrade bleaching (anticipated to be based on at least 100
percent chlorine dioxide substitution and no hypochlorite use) is at
least as stringent as the MACT floor (high chlorine dioxide
substitution). Therefore, EPA plans to specify papergrade BAT as
compliance for chloroform at paper grade bleach plants. EPA requests
comments on whether an alternative equivalent numerical limit for
chloroform is needed for papergrade bleaching processes.
EPA's intent for bleaching wastewater is unchanged from proposal
(i.e., no control). New source MACT for bleach plants would be the same
as existing source MACT for both papergrade and dissolving grade bleach
plants. The installation and operation of the totally chlorine free
(TCF) bleaching process meets all the bleaching process MACT standards
for papergrade bleaching and would constitute compliance.
VII. Compliance Extension for Kraft Mills
EPA is committed to the goals of the cluster rule, and believes
that the cluster rule will ultimately result in lower overall
compliance costs, while still providing environmental and human health
protection. However, EPA recognizes the unique compliance and timing
issues that the cluster rule may create. EPA has identified one
situation that may warrant additional compliance time to fully realize
the goals of this rule. EPA is inclined to agree with industry
representatives who have stated that additional time is warranted for
brownstock washers and oxygen delignification units at kraft mills. EPA
believes the additional time would ensure that the maximum degree of
overall multi-media pollution reduction is achieved, without requiring
unnecessary compliance costs.
Many kraft mills are currently considering the addition of oxygen
delignification (OD) to their pulping process lines by the year 2000.
The addition of OD has been shown to have significant environmental
benefit. An OD unit reduces the need for chlorinated chemical
application in the bleaching process, which results in reduced loadings
of chlorinated pollutants to the air and into the bleach plant
effluent. Less water is required in the bleaching process which, in
turn, brings a mill closer to the ``closed mill'' design, with zero
water discharge. EPA is strongly committed to pollution prevention
efforts such as these. There is also a cost savings for the industry by
using OD in the form of reduced chemical usage and less net energy
usage.
To gain the maximum benefit from adding OD units, the brownstock
washers typically need to be redesigned to improve pulp washing. The
trend in the industry is toward newer washing technologies that are
more efficient, require smaller space in the mill, are less polluting
and easier to control. EPA encourages the use of these pollution
prevention technologies, but recognizes the evaluation and
implementation of
[[Page 9395]]
these technologies would add time and expense to the compliance
activities for these sources.
EPA is particularly concerned that if mills had to control vents on
brownstock washers within the 3-year compliance period, time
constraints would dictate that they retrofit their current washers with
a vent gas collection system. Once such a collection system is
installed, mills would likely postpone installation of OD or choose not
to install it at all; as discussed earlier, installation of OD
generally requires brownstock washer upgrades. The upgraded washers
plus the new OD system would require a differently designed gas
collection system. Once mills commit capital to retrofit their current
equipment, they would be very unlikely to entertain technologies such
as OD that would require tearing out and rebuilding or replacing the
gas collection system within a few years. (In such a case, there is a
serious question whether imposition of a standard that results in
foregoing substantial cross-media environmental benefits could be MACT.
Portland Cement Association v. Ruckelshaus, 486 F.2d 375, 385-86 at
n.42 (DC Cir. 1973); Essex Chemical Corp. v Ruckelshaus, 486 F.2d 427,
439 (DC Cir. 1973), EPA must consider non-air environmental impacts in
determining what constitutes a ``best'' technology.)
EPA considers the installation of improved washers and OD to be an
important step toward totally chlorine free bleaching. Total chlorine
free bleaching, while still evolving, provides significant benefits
such as elimination of chlorinated pollutants to the environment and
allows bleach plant effluents to be recycled to the mill. These
benefits result in a large reduction in mill water intake and moves a
mill further toward the closed mill concept.
This additional design and mill modification can be a lengthy
process. EPA wants to allow sufficient time for each mill to fully
consider all pollution control options. EPA also recognizes that the
pulp and paper industry will be implementing both water and air rules
essentially at the same time; many of the changes a mill will need to
implement to comply with the water requirements must be considered
before control of air emissions from the washer and OD systems can be
enacted. Given the engineering requirements, capital expenditures,
permitting requirements, and the time necessary to implement the water
standards, EPA questions whether it is even possible to install
controls for air emissions from OD and washers currently in place
within 3 years.
Much of the discussion in this section is centered around OD. It
must be pointed out that while OD may not be included in the control
basis for BAT at kraft mills, EPA is considering taking a number of
steps, this compliance extension being one, to encourage mills to adopt
the technology. EPA's Office of Water, in a separate Federal Register
notice to follow shortly, will address the process technologies that
are likely to be considered as the underlying basis for BAT effluent
limitations. EPA also will present a plan for incentives being
considered for mills that have installed or will install technologies
that achieve more stringent removal of pollutants from wastewater than
is likely to be required based on BAT.
EPA is thus considering providing an additional 5 years beyond the
3-year compliance time for the remaining units for a total compliance
time of 8 years from the date of promulgation. EPA believes this would
allow sufficient time for a complete evaluation of all pollution
control options. Some limited information on the status of their
compliance activities for these sources would likely be required in
their annual compliance report.
EPA is, of course, aware that section 112 (i) (3) (A) states that
compliance with a MACT standard shall be no later than 3 years from the
standard's effective date. EPA notes, however, that there are special
circumstances present in this instance. First, as described above, a
three year compliance period raises the likelihood of mills which might
otherwise choose to install OD foregoing water quality and pollution
prevention benefits if they are forced to retain their existing
brownstock washing system in order to justify the capital cost of vent
controls on that system. Second, as a legal matter, EPA could develop a
rule with the same contemplated compliance date (i.e. of 2004) by
simply rescheduling this part of the pulp and paper air rule into the
so-called 10-year bin under section 112 (e) (1) (E), and rescheduling a
10-year rule. (Section 112 (c) (1) contemplates revisions in EPA's
initial schedule, and EPA has been held to have continuing discretion
to reschedule under a similar scheduling scheme in the Resource
Conservation and Recovery Act. Chemical Waste Management v. EPA, 869 F.
2d 1526 at n. 2 (D.C. Cir. 1989).) Because of the benefits of the
cluster rulemaking process, which allows EPA to develop and affected
companies and members of the public to gauge the multi-media effect of
contemplated rules at one time, EPA prefers to promulgate the standards
at the same (or close to the same) time. EPA does not believe the
cluster process needs to be abandoned to provide a compliance date it
could achieve by other means.
Much of the rationale for the compliance extension is to encourage
kraft mills to install superior water pollution-control technology, yet
the extended compliance time line contemplated in this notice would be
available to all kraft mills, whether or not they choose to adopt that
superior technology. EPA solicits comments on whether such a compliance
extension should only be available to mills that commit to install
technologies that achieve more stringent removal of pollutants from
wastewater than is likely to be required based on BAT.
VIII. Emissions Averaging
The proposed regulations did not contain provisions for emissions
averaging; however EPA requested comments on the subject. EPA is
interested in emissions averaging because it is equally protective,
adds flexibility, and can also reduce the costs of compliance and
testing. At proposal, EPA did not include an emissions averaging
approach because of data limitations and concerns over how to implement
an averaging approach due to concerns about process variability.
Several commentors indicated support for emissions averaging on the
basis of providing compliance flexibility for the industry, but stated
that an individual approach to emissions averaging, such as
contemplated at proposal, would be too burdensome and inappropriate for
this industry. Conversely, some commentors indicated that emissions
averaging would be difficult to enforce.
After proposal, the industry submitted a concept for compliance
with the proposed NESHAP regulations that is an alternative type of
emissions averaging that is unique and potentially more appropriate for
this industry. While the proposed NESHAP regulations focus primarily on
combustion of specific process vents, the industry provided preliminary
information detailing an alternative compliance plan designed to reduce
the amount of HAP's present in pulping condensate streams that are
recycled to other process areas in the mill (docket item IV-D1-95).
Recent industry data has indicated that a significant portion of
emissions from process areas such as brownstock washing and
causticizing area could be attributed to volatilization of compounds
present in the recycled condensates. Reducing the pollutant
concentration in the recycled condensates would, in turn, lower the
amount of pollutants volatilized from process areas that receive
recycled
[[Page 9396]]
condensates and reduce emissions from bleach plants and paper machines
associated with HAP carry over from pulp washing processes.
The industry's compliance alternative, referred to as the ``Clean
Water Alternative,'' consists of routing pulping area condensates to a
biological reactor to remove the HAP's. The effluent from the reactor
could then be used in other process areas in the mill (e.g., brownstock
washing, causticizing area, etc.). The emission reduction achieved by
the alternative would be associated with using condensates with lowered
HAP concentrations throughout the mill.
The industry believes that significantly reducing the HAP
concentration in recycle process waters using the biological reactor
would achieve greater HAP emissions reduction across the whole source
than the proposed NESHAP. EPA is currently evaluating whether the
industry's clean water alternative would achieve or exceed the HAP
emissions reduction achievable using the control techniques on which
the proposed regulations are based. In addition, EPA will be evaluating
secondary impacts associated with using the clean water alternative.
Conceptually, the industry's proposal would reduce emissions from
process units that receive recycled condensates. Biodegradation of HAP
compounds has been widely documented; however, this approach to
emissions reduction has not been demonstrated in the pulp and paper
industry.
While the industry's clean water alternative is innovative,
additional information must be provided in order to make this proposal
a viable compliance option. Industry supplied additional data to
improve the emission factors (docket item IV-D1-59), but the data was
not sufficient to address EPA's concerns about process variability. The
types of information EPA is interested in obtaining to address these
concerns are: (1) Detailed information, such as: emission calculations;
assumptions used; references; typical process/condensate flow diagrams
(if needed); data supporting relationship between stream concentration
and air emissions; any other data/information necessary to support an
independent evaluation of the industry's claims of performance; (2)
strategies for demonstrating compliance with the NESHAP regulations,
such as the specific reactor performance parameters to be monitored
(e.g., inlet and outlet HAP concentration, hot water tank outlet HAP
concentration, temperature of recycled water; identification of process
equipment receiving treated condensates); and (3) methods for enforcing
compliance with the NESHAP regulations using the industry's
alternative, such as sufficient recordkeeping and reporting
requirements associated with reactor operation.
IX. Relationship to Other Rules
A. New Source Review/Prevention of Significant Deterioration
Applicability
To comply with the MACT portion of the pulp and paper cluster rule
under development, mills will route vent gases from specified pulping
emission points to a combustion control device for destruction. Mills
may use steam strippers to reduce emissions from pulping wastewater.
The incineration of sulfur-laden gases from pulping vents and/or steam
stripper overheads has the potential to generate sulfur dioxide
(SO2). To a lesser degree, the use of supplemental fuels to
support vent gas combustion and the generation of additional steam for
steam strippers may increase emissions of SO2, nitrogen oxides,
particulate matter (PM and PM10), and carbon monoxide.1 For
these reasons, commentors have indicated that compliance with the
proposed cluster rule could trigger major NSR or PSD review.
\1\ Commentors raised similar concerns with respect to the
technologies that would be installed to meet the proposed effluent
limitations in the cluster rule. These issues will be addressed in
the forthcoming water notice.
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Industry and some States have commented extensively on the
potential problems resulting from the interaction of the cluster rule
under development and NSR. They have indicated that in developing the
rule, EPA did not take into account the impacts that would be incurred
in triggering NSR. Commentors indicated that PSD or NSR review
processes would: (1) Cost the pulp and paper industry significantly
more for permitting and implementation of NSR and PSD requirements than
predicted by EPA; (2) impose a large permitting review burden on State
air quality offices; and (3) present difficulties for mills to meet the
proposed NESHAP compliance schedule of three years due to the time
required to obtain a pre-construction permit. Commentors indicated that
compliance with the proposed rule would make permitting extremely
complex, pointing out that in some cases, sources would be required by
one set of regulations to install emissions controls and constrained
from beginning construction on those controls in the absence of a
permit by another set of regulations. The commentors also suggested
that EPA provide an exemption from major source NSR and PSD review,
preferably using the pollution control project exclusion.2
\2\ A similar issue was resolved in the 1992 WEPCO rulemaking,
where EPA amended its PSD and nonattainment NSR regulations as they
pertain to electric utilities, by adding certain pollution control
projects to the list of activities excluded from the definition of
physical or operational changes, subject to certain safeguards.
Pollution control projects were defined as ``any activity or project
undertaken [at an existing electric utility steam generating unit]
for purposes of reducing emissions from such a unit.''
In a July 1, 1994 guidance memorandum issued by EPA (available
on the TTN Bulletin Board), EPA extended a limited pollution control
project exclusion for source categories other than electric
utilities. The guidance indicated that unless information regarding
a specific case indicates otherwise, add-on controls and fuel
switches to less polluting fuels can be presumed, by their nature,
to be environmentally beneficial.
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Based on evaluation of pollutant reductions, environmental, and
energy impacts, EPA considers projects implemented to comply with the
MACT portion of the cluster rule to be environmentally beneficial. EPA
therefore considers these projects to be pollution control projects
under current policy guidance issued in an EPA memorandum dated July 1,
1994. As discussed in the guidance, the exclusion does not affect any
minor NSR permitting requirements in a State implementation plan, which
also facilitates the safeguards outlined in the policy guidance.
Further, EPA expects that projects undertaken to meet the MACT portion
of the cluster rule will also qualify as PCP's under forthcoming NSR
reform regulations.
EPA solicits public comment on its determination that control
device projects installed to comply with the MACT portion of the
cluster rule are environmentally beneficial and eligible for exemption
from major NSR as PCP's under current policy guidance. EPA also
solicits public comments on providing a specific exclusion in the major
NSR rules for these types of controls installed to comply with the MACT
portion of the cluster rule.
B. Boiler/Industrial Furnace/Resource Conservation and Recovery Act
Applicability
The proposed pulp and paper NESHAP requires the use of steam
stripping to remove HAP's, primarily methanol, from wastewater. After
removal, the NESHAP would require the HAP-laden vent gases from the
steam stripper to be sent to a combustion device for destruction.
Several commentors indicated that sending the steam stripper overheads
to a combustion device was not the most efficient and cost effective
way to destroy vent gases due to the high
[[Page 9397]]
moisture content and variable heat value of these vent gases. The
commentors recommended sending the stripper vent gases to a
rectification column followed by condensation to obtain a concentrated
condensate (primarily methanol). The concentrated condensate could then
be burned in an on-site combustion device as fuel.
This approach to condense and burn the concentrated condensate
takes advantage of the condensate's energy value and should assure
substantial destruction of HAP's due to the MACT standard. However, as
explained below, under current rules, condensing the steam stripper
vent gases could result in RCRA regulation of the condensate, including
regulation of the combustion unit.
As proposed, the combustion of steam stripper vent gas does not
trigger the BIF regulations because the methanol-laden vent gas is not
a RCRA hazardous waste--it is not listed as a hazardous waste, nor does
it exhibit a hazardous waste characteristic. However, if the methanol
from the steam stripper overheads is condensed before burning, the
flash point of the liquid drops to below 140 degrees Fahrenheit, and
the liquid may therefore be identified as hazardous waste because it
exhibits the ignitability characteristic (set out in 40 CFR
Sec. 261.21). To avoid the imposition of RCRA BIF regulations,
commentors recommended incorporating a ``clean fuels'' exemption into
the pulp and paper NESHAP so that the condensate can be burned for
energy recovery without the combustion unit also being subject to the
RCRA rules.
The ``clean fuels'' exemption is a recommendation from EPA's Solid
Waste Task Force (SWTF) to allow recovery of energy from ``clean''
waste-derived fuels such as ethanol, methanol, and hexane. The
recommendation is contained in ``Re-engineering RCRA for Recycling''
(EPA 530-R-94-016, November 1994). The ``clean fuels'' exemption was
developed by the SWTF to promote burning for energy recovery hazardous
waste fuels that are considered hazardous only because they exhibit the
ignitability characteristic (i.e., have a flash point below 140 degrees
Fahrenheit).
The industry submitted information detailing the composition of
condensates derived from steam stripper overhead gases (docket items
IV-D1-51 and IV-D1-56). However, the determination if the condensates
meet the requirements for the clean fuels exemption has not yet been
conducted by EPA's Office of Solid Waste. Indeed, the soon-to-be
proposed standard for hazardous waste combustion units proposes
exclusions based on a comparable fuel test (rather than a risk-based
test of how ``clean'' the fuel is) involving a comparison with fossil
fuels.
EPA does not believe as an initial matter that RCRA regulation of
combustion of the condensate is needed. Although the clean fuel and
comparable fuel approaches are too nascent for immediate national
application, it still appears that this condensate could be combusted
pursuant to the MACT standard without presenting risks warranting
immediate RCRA control. The condensate does not appear to contain metal
or chlorinated organic HAP's; a volatile HAP (methyl ethyl ketone at
1638 milligrams per liter (mg/l)) and a volatile compound (acetone at
2364 mg/l) were the maximum concentrations detected, and they would be
substantially destroyed under the MACT standard. In addition, EPA
believes that allowing the burning of this condensate does not produce
any additional HAP's due to the high temperatures and residence times
found in pulp and paper combustion devices that would be used to comply
with the proposed MACT standard. Moreover, burning condensate will not
increase the potential environmental risk over the burning of the steam
stripper vent gases prior to condensation. Additionally, the use of the
condensate as a fuel could reduce or eliminate the need for
supplemental firing of fossil fuels in such combustion devices, thereby
decreasing the emission of criteria pollutants (NOX, PM, SO2,
CO). Consequently, EPA believes that regulation under RCRA is not
necessary since the practice would not increase environmental risk,
reduces secondary impacts, and would provide a cost savings. Further
considerations of risk can appropriately be handled as part of the
section 112(f) residual risk determination. For these reasons, EPA is
proposing to exempt specific sources at kraft mills that burn
condensates derived from steam stripper overheads from the BIF
requirements of RCRA.
This decision is consistent with RCRA section 1006, which requires
EPA to ``integrate all provisions of [RCRA] for purposes of
administration and enforcement and * * * avoid duplication, to the
extent practicable, with the appropriate provisions of the Clean Air
Act * * *.'' EPA believes that the imposition of RCRA regulations in
this instance could result in the types of unnecessary duplication that
section 1006 is intended to prevent. EPA now considers that steam
stripping with rectification followed by combustion of the concentrated
condensate is MACT considering energy, economics, and air environmental
impacts. Additional regulation under RCRA is redundant and not likely
to result in any additional emission or risk reduction. Any further
concerns on this issue would more properly be addressed through the
section 112(f) residual risk process which requires EPA to assess the
risk to public health remaining after implementation of the NESHAP
under section 112(d). See generally 60 FR 32587, 32593 (June 23, 1995),
and 59 FR 29570, 29776 (June 9, 1994) where EPA similarly found that
RCRA regulation of secondary lead smelter emissions was unnecessary, at
least until completion of the residual risk process.
EPA believes the potential cost savings produced by allowing the
burning of condensed steam stripper vent gases would be significant.
Industry estimates that annual cost savings would be approximately
$850,000 per mill, or $100 million for the entire kraft industry. Cost
savings would come primarily through the reduction in fossil fuel
purchases.
C. Kraft New Source Performance Standards
EPA is considering whether the New Source Performance Standards
(NSPS) for kraft mills and the proposed pulp and paper NESHAP standards
may have some overlapping or redundant requirements. Possible areas of
overlap in the two regulations are affected sources or emission points,
monitoring, recordkeeping, and reporting requirements. EPA solicits
comments on the potential overlap of the kraft NSPS and the proposed
NESHAP standards.
The kraft NSPS established emission limits for PM and total reduced
sulfur TRS compounds for the following new or modified emission sources
located at kraft mills: recovery furnaces, digesters, multiple effect
evaporators, lime kilns, brownstock washers, black liquor oxidation
systems, condensate stripper systems, and smelt dissolving tanks. The
pulp and paper NESHAP will establish national limits for total HAP
emissions from the following sources at all types of new or existing
chemical pulping mills: digester, evaporator, turpentine recovery,
brown stock washer, and condensate stripper systems. Total reduced
sulfur and HAP compounds are found in the process vents affected by
both the NSPS and NESHAP regulations.
The kraft NSPS requires monitoring of the following parameters:
opacity from the recovery furnace, TRS emissions from affected points,
incinerator temperature, and process variables for any scrubber used
for controlling
[[Page 9398]]
emissions from a lime kiln or smelt dissolving tank. The NESHAP
requires monitoring of the following parameters or pieces of equipment:
closed vent system, combustion device temperature, scrubber, steam
stripper, biological treatment, and the wastewater collection system.
While the NSPS requires monitoring of TRS emissions for the most part,
the NESHAP focuses on monitoring the performance of specific pieces of
equipment.
Recordkeeping duties specified in the NSPS include logging of daily
opacity and TRS emissions data. For the specified collection or control
devices used to comply with the NESHAP, the monitoring parameters
identified in the rule must be recorded in a manner consistent with the
General Provisions. EPA solicits data and comments on whether these
different approaches create unnecessarily redundant or overburdensome
monitoring or recording requirements.
The NSPS requires semi-annual reporting detailing the periods of
excess emissions. Quarterly reports regarding excess emissions and
continuous monitoring system performance are currently required by the
proposed NESHAP. The NESHAP reporting frequencies are currently under
review and will be revised to be no more stringent than the
requirements specified in the General Provisions. Additionally, the
NESHAP requires exceedance reports for startups, shutdowns, or
malfunctions that are inconsistent with the source's specified
operating procedures. One option under consideration by EPA is to allow
the facility to comply with the NESHAP in lieu of complying with the
NSPS for certain pieces of process equipment. EPA solicits data and
comments on the extent to which these reporting requirements could or
should be combined or reduced.
X. Standards for Mechanical Mills, Secondary Fiber Mills, Nonwood Mills
and Paper Machines
A. Presumptive MACT Process
As previously mentioned in the Background Section, a Presumptive
MACT was issued for the MACT III (i.e. mechanical wood pulping mills,
secondary fiber deinking and nondeinking mills, nonwood pulping mills,
and paper machines) source category in September of 1995. Presumptive
MACT is an estimate of MACT based on an assessment of readily available
information and through consultation with experts in State and local
agencies, EPA, environmental groups, and the regulated industry. A
primary purpose for Presumptive MACT is to assist State and local
agencies, industry, and the public in Section 112(g) case-by-case MACT
determinations and with the Section 112(j) hammer provision standards.
The process is useful to enhance planning in the standards development
process. Through the Presumptive MACT process issues can be identified
and resolved early in the standards development process; the
``stakeholders'' can be identified; and the best method to develop MACT
can be determined (e.g., traditional regulatory development, Adopt-A-
MACT, Share-A-MACT, or proposing the Presumptive MACT as MACT).
B. Summary of the Presumptive MACT for MACT III Sources
For the MACT III source category, EPA contacted representatives of
major industry, State, and environmental groups and held discussions
with a team of State and industry representatives. The team evaluated
the information that was available and established the Presumptive
MACT. The pulp and paper Presumptive MACT is available on the Office of
Air Quality Planning and Standards Technology Transfer Network (TTN)
under the Clean Air Act Amendments, Title III Policy and Guidance
Bulletin Board. The Presumptive MACT document is also available in the
docket (see SUPPLEMENTARY INFORMATION section).
Limited information on the source category was identified during
the Presumptive MACT process. The available information identified four
potential sources for HAP emissions: pulping, wastewater from the
pulping process, bleaching, and paper making. Of these, chlorine
bleaching would be a likely source of HAP emissions, assuming
operations in use are similar to those used by bleach plants at
chemical wood pulping mills. Paper machines were also considered an
emission source because of the use of paper additives and solvents.
Nonwood pulping processes and the associated wastewater are potential
sources of HAP emissions based on similarities between these and
chemical wood pulping operations; however, the magnitude of the
emissions could not be determined for these or the other potential
sources from the available information. Information indicated secondary
fiber deinking and nondeinking mills are not a significant source of
HAP emissions (Docket A-95-31 item II-B-1).
Information on current control practices suggests the mills have no
add-on controls in place for HAP emissions except on chlorine
bleaching. There are, however, a number of control options that can be
considered. Besides the add-on controls at bleach plants (scrubbers
that remove chlorine and hydrogen chloride) chlorine-free bleaching may
be in use at some mills. Methanol emissions from paper machines
resulting from recycled water from the pulping process are to be
addressed by the chemical wood pulping standards (see section IV
Definition of Source); however, emissions from paper machines that
result from the use of paper additives and solvents were addressed by
the Presumptive MACT. The Presumptive MACT suggested these emissions
may be reduced through substituting additives and solvent for nonHAP or
lower-HAP alternatives. MACT III for pulping operations, low volume-
high concentration gas streams may be routed to a combustion device (as
would be required in the MACT I discussed earlier in this notice).
Lastly, high concentration wastewater streams may be treated through
biological treatment or by steam stripping of the HAP and controlling
emissions from the steam stripper.
One of the conclusions of the Presumptive MACT was to proceed with
MACT standard development through the traditional rulemaking process.
EPA has since reconsidered this position, given the findings during the
Presumptive MACT process and EPA's current budget limitations. EPA has
now decided to propose the Presumptive MACT as MACT.
C. Area/Major Source Discussion
No information was identified during the Presumptive MACT process
to suggest area sources associated with the MACT III source category
warrant listing as a category of area sources, pursuant to Section
112(c)(3) of the Act. Consequently, only major sources were evaluated
for this category. EPA also has no evidence that any facilities that
are solely nonwood mills are major emission sources in and of
themselves. Major sources are sources within a contiguous area that
emit or have a potential to emit, 10 tpy or more of any HAP or 25 tpy
or more of any combination of HAP. Industry has published information
in an NCASI Technical Bulletin, Number 677 (Docket A-95-31 item II-D-
13), on two emission points at a thermomechanical pulping mill. The two
emission points were the refiner condenser vent and the chip steaming
condenser vent. Total HAP emissions estimated from the two points
tested at this mill were approximately 8 tons per year. It is not
[[Page 9399]]
known if remaining emission points not tested at this mill emit enough
additional HAP to be a major source, or if a larger thermomechanical
mill would be a major source. NCASI also published a Technical
Bulletin, Number 649 (Docket A-95-31 item II-D-12) on emissions from
operations that bleach and brighten secondary fibers. This bulletin was
based on sampling conducted in 1991 and 1992. Due to an increase in the
demand for secondary fiber, these mills have increased in size since
the 1991/1992 sampling program. Therefore, large stand alone secondary
fiber mills may exist that have HAP emissions large enough to be major
sources. Where these MACT III mills are collocated at kraft, sulfite,
semi-chemical, and soda mills that are major sources, they will be
subject to MACT standards; however, the only emission sources that
would be affected by the MACT III proposed standard are the MACT III
bleach plants and possibly the paper machines (for emissions resulting
from solvent or additive use). EPA knows of no additional bleach plants
that would be subject to MACT standards because of their collocation at
a MACT I mill that is a major source. Paper machines will only be
affected if EPA decides to establish additive and/or solvent
substitution as MACT.
D. Proposed MACT III
The information gathered during the Presumptive MACT process
indicates that there are no air pollution control devices in place on
MACT III sources except for chlorine bleaching processes. Based on this
finding, the floor for these sources is no control. Further, available
information indicates any add-on controls would not be cost effective
for these sources. Therefore, EPA has decided not to require controls
beyond the floor. The MACT proposed here for the MACT III sources is no
add-on controls for pulping and the associated wastewater, paper
machines, and nonchlorine bleaching.
Bleach plants at MACT III sources collocated with MACT I sources
are presently regulated under the MACT I standard (see Section VI.E,
Level of Standards). Based on information provided by industry, EPA
believes traditional bleach plants using chlorinated bleaching agents,
such as those found at Kraft mills, that are located at stand-alone
MACT III mills are presently controlled with scrubbers that remove
chlorine and hydrogen chloride for process or worker safety reasons.
EPA is not aware of any better control that could be used. Therefore,
control of air emissions from these bleach plants is already in place
and the proposed MACT for bleach plants at stand-alone MACT III
facilities is no additional control.
EPA is proposing no MACT standard for chemical additives and
solvents at paper machines at this time. EPA continues to investigate
the use of HAP chemicals in papermaking, the magnitude of HAP
emissions, and the viability of chemical substitution that would reduce
HAP emissions. An example of chemical substitution is substitution of
HAP-containing additives and solvents with lower HAP or non-HAP organic
compounds. If information becomes available regarding the floor or
cost-effective HAP controls beyond the floor, EPA will propose a MACT
standard for additive and solvent usage on paper machines in the
future.
E. Request for Information
Additional information is being collected by industry groups, which
began a testing program in September 1995. This program is designed to
evaluate emissions from mechanical pulping processes, secondary fibers
pulping processes, and paper machines. Industry plans to have the
report on this sampling program available in January of 1997. EPA has
also requested any available information on HAP emissions from nonwood
mills from States with these mills; however, limited data are expected
to be available. EPA is requesting any information on uncontrolled
bleaching using chlorinated bleaching agents at stand-alone MACT III
sources. To supplement the information collected during the Presumptive
MACT and the more recent industry and EPA efforts, EPA is requesting
data and comments on its proposal for the MACT III source category.
List of Subjects in 40 CFR Part 63
Air pollution control, Hazardous air pollutants, Pulp and paper
mills.
Dated: March 1, 1996.
Richard S. Wilson,
Assistant Administrator for Air and Radiation.
[FR Doc. 96-5397 Filed 3-7-96; 8:45 am]
BILLING CODE 6560-50-P
Complete official Federal Register PDF
FR Doc. 96-5264 Proposed Amendments to the Regulations on the Determination of Interest Expense Deduction of Foreign Corporations and Branch Profits Tax
[Federal Register Volume 61, Number 47 (Friday, March 8, 1996)]
[Proposed Rules]
[Pages 9377-9380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5264]
=======================================================================
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DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[INTL-0054-95]
RIN 1545-AT96
Proposed Amendments to the Regulations on the Determination of
Interest Expense Deduction of Foreign Corporations and Branch Profits
Tax
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Notice of proposed rulemaking and notice of public hearing.
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SUMMARY: This document contains proposed Income Tax Regulations
relating to the determination of the interest expense deduction of
foreign corporations under section 882 and the branch profits tax under
section 884 of the Internal Revenue Code of 1986. These proposed
regulations are necessary to provide guidance that coordinates with
guidance provided in final regulations under sections 882 and 884
published elsewhere in this issue of the Federal Register. These
regulations will affect foreign corporations engaged in a U.S. trade or
business. This document also provides notice of a public hearing on
these proposed regulations.
[[Page 9378]]
DATES: Written comments must be received by June 6, 1996. Outlines of
topics to be discussed at the public hearing scheduled for Thursday,
June 6, 1996, at 10 a.m. must be received by May 23, 1996.
ADDRESSES: Send submissions to: CC:DOM:CORP:R (INTL-0054-95), room
5228, Internal Revenue Service, POB 7604, Ben Franklin Station,
Washington DC 20044. In the alternative, submissions may be hand
delivered between the hours of 8 a.m. and 5 p.m. to CC:DOM:CORP:R
(INTL-0054-95), Courier's Desk, Internal Revenue Service, 1111
Constitution Avenue NW., Washington DC. The public hearing will be held
in the Auditorium, Internal Revenue Building, 1111 Constitution Avenue
NW., Washington DC.
FOR FURTHER INFORMATION CONTACT: Concerning the regulations, Ahmad
Pirasteh or Richard Hoge, (202) 622-3870; and the hearing, Michael
Slaughter (202) 622-7190 (not toll-free numbers).
SUPPLEMENTARY INFORMATION:
Background
This document contains proposed regulations amending the Income Tax
Regulations (26 CFR Part 1) under sections 882 and 884 of the Internal
Revenue Code. In final regulations under sections 882 and 884,
published elsewhere in this issue of the Federal Register, various
sections were reserved. These proposed regulations would provide
guidance under those reserved sections, as well as amend other
sections, to coordinate with the final regulations.
Explanation of the Provisions
I. Financial Products
The proposed regulations include several provisions that take into
account recent developments in the tax treatment of financial
instruments, such as the enactment of section 475, the development of
hedging rules and the introduction of profit split methodologies in
global trading Advance Pricing Agreements. The IRS and Treasury intend
to issue regulations under section 864 that will address these recent
developments as they affect the determination of a foreign
corporation's effectively connected income. Comments are solicited on
these proposed regulations as they relate to financial products and on
their interaction with the determination of effectively connected
income.
A. ``Split asset'' rule for section 475 securities and section 1256
contracts. Currently Sec. 1.884-1(d)(2)(vii) provides a ``split asset''
rule for certain securities described in Sec. 1.864-4(c)(5)(ii)(b)(3)
that produce income only a portion of which is treated as effectively
connected with the conduct of a U.S. trade or business. Since other
securities may also produce income split between effectively connected
and non-effectively connected income, the rule has been broadened to
cover all financial instruments that meet the definition of a security
under section 475(c)(2), as well as section 1256 contracts, that may
produce such split income. Accordingly, a foreign corporation that,
under an Advance Pricing Agreement, is permitted to apply a ``profit
split'' methodology to determine the portion of its income from a
portfolio of securities that is effectively connected with the conduct
of a U.S. trade or business would apply this rule. This rule will also
apply to determine the portion of a foreign corporation's portfolio of
securities that is a U.S. asset for purposes of Sec. 1.882-5.
B. Hedging transactions. Proposed Sec. 1.884-1(c)(2)(ii) introduces
a new rule for hedging transactions for purposes of section 884. The
new rule requires that a taxpayer increase or decrease, as the case may
be, the amount of their U.S. assets by the amount of any gain or loss
on any transaction that hedges the U.S. assets. If the hedging
transaction is undertaken outside the United States, perhaps as part of
a global hedging strategy of the foreign corporation, then the hedging
transaction is only taken into account to the extent that income from
the transaction would be treated as income effectively connected with
the U.S. trade or business of the taxpayer. If, however, the hedging
transaction is entered into by the U.S. branch, it will only affect the
amount of U.S. assets if it is contemporaneously identified as a
hedging transaction in accordance with the provisions of Sec. 1.1221-2.
In response to comments, hedging rules also have been added to the
interest allocation rules of Sec. 1.882-5. These rules provide that a
transaction that hedges a U.S. booked liability will be taken into
account in determining the amount, currency denomination, and interest
rate associated with that liability for purposes of performing the
second and third steps of the interest expense calculation.
C. Securities marked-to-market. Section 1.884-1(d)(6), which
provides ``E&P basis'' rules for specific types of U.S. assets, has
been clarified to provide rules for securities subject to mark-to-
market accounting. The new provision in Sec. 1.884-1(d)(6)(v) specifies
that securities subject to section 475, as well as section 1256
contracts, have an E&P basis equal to their mark-to-market value as of
the determination date. Proposed Sec. 1.882-5(b)(2)(iv) provides a
basis adjustment rule under which such assets are treated as having
been marked-to-market on each determination date. Examples are
contained in the proposed regulations that illustrate the effect of
these rules on the calculation of worldwide assets and liabilities.
II. Transactions Between Partners and Partnerships
Example 4 in proposed Sec. 1.882-5(c)(5) would clarify that an
obligation of a partnership to make payments to its partner for the use
of capital, which gives rise to guaranteed payments under section
707(c), is not a liability for purposes of Sec. 1.882-5. The Service
and Treasury solicit comments on the treatment of loans between
partners and partnerships as part of Treasury's review of the
international tax aspects of pass-through entities.
Special Analyses
It has been determined that this notice of proposed rulemaking is
not a significant regulatory action as defined in EO 12866. Therefore,
a regulatory assessment is not required. It has also been determined
that section 553(b) of the Administrative Procedures Act (5 U.S.C.
chapter 5) and the Regulatory Flexibility Act (5 U.S.C. chapter 6) do
not apply to these regulations, and, therefore, a Regulatory
Flexibility Analysis is not required. Pursuant to section 7805(f) of
the Internal Revenue Code, this notice of proposed rulemaking will be
submitted to the Chief Counsel for Advocacy of the Small Business
Administration for comment on its impact on small business.
Comments and Request for a Public Hearing
Before these proposed regulations are adopted as final regulations,
consideration will be given to any written comments (signed original
and eight (8) copies) that are timely submitted to the IRS. All
comments will be available for public inspection and copying.
A public hearing has been scheduled for Thursday, June 6, 1996, at
10 a.m. in the Auditorium, Internal Revenue Building, 1111 Constitution
Avenue NW., Washington DC. Because of access restrictions, visitors
will not be admitted beyond the building lobby more than 15 minutes
before the hearing starts.
The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons
that wish to present oral comments at the hearing
[[Page 9379]]
must submit written comments by June 6, 1996, and submit an outline of
topics to be discussed and time to be devoted to each topic (signed
original and eight (8) copies) by May 23, 1996.
A period of 10 minutes will be allotted to each person for making
comments.
An agenda showing the scheduling of the speakers will be prepared
after the deadline for receiving outlines has passed. Copies of the
agenda will be available free of charge at the hearing.
Drafting Information
Several persons from the Office of Chief Counsel and the Treasury
Department participated in drafting these regulations.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and recordkeeping requirements.
Proposed Amendments to the Regulations
Accordingly, 26 CFR part 1 is proposed to be amended as follows:
PART 1--INCOME TAXES
Paragraph 1. The authority citation for part 1 continues to read in
part as follows:
Authority: 26 U.S.C. 7805. * * *
Par. 2. Section 1.882-5 is amended as follows:
1. The text of paragraph (b)(2)(iv) is added.
2. The text of paragraph (c)(2)(v) is added.
3. In paragraph (c)(5), Example 4, Example 6, and Example 7 are
added.
4. The text of paragraph (d)(2)(vi) is added.
5. In paragraph (d)(6), Example 4 is added.
6. The text of paragraph (e)(3) is added.
7. In paragraph (e)(5), Example 2 is added.
8. The text of paragraph (f)(2) is added.
The added provisions read as follows:
Sec. 1.882-5 Determination of interest deduction.
* * * * *
(b) * * *
(2) * * *
(iv) Adjustment to basis of financial instruments. The basis of a
security or contract that is marked to market pursuant to section 475
or section 1256 will be determined as if each determination date were
the last business day of the taxpayer's taxable year. A financial
instrument with a fair market value of less than zero is a liability,
not an asset, for purposes of this section.
* * * * *
(c) * * *
(2) * * *
(v) Hedging transactions. A transaction (or transactions) that
hedges an asset or liability, or a pool of assets or a pool of
liabilities, will be taken into account in determining the value,
amount and currency denomination of the asset or liability that it
hedges. A transaction will be considered to hedge an asset or liability
only if the transaction meets the requirements of Sec. 1.1221-2.
* * * * *
(5) * * *
Example 4. Partnership liabilities. X and Y are each foreign
corporations engaged in the active conduct of a trade or business
within the United States through a partnership, P. Under the
partnership agreement, X and Y each have a 50% interest in the
capital and profits of P, and X is also entitled to a return of 6%
per annum on its capital account that is a guaranteed payment under
section 707(c). In addition, P has incurred a liability of $100x to
an unrelated bank, B. Under paragraph (c)(2)(vi) of this section, X
and Y each share equally in P's liability to B. In accordance with
U.S. tax principles, P's obligation to make guaranteed payments to X
does not constitute a liability of P, and therefore neither X nor Y
take into account that obligation of the partnership in computing
their actual ratio.
* * * * *
Example 6. Securities in ratio as assets. FC is a foreign
corporation engaged in a trade or business in the United States
through a U.S. branch. FC is a dealer in securities within the
meaning of section 475(c)(1)(B) because it regularly offers to enter
into positions in currency spot and forward contracts with customers
in the ordinary course of its trade or business. FC has not elected
to use the fixed ratio. On December 31, 1996, the end of FC's
taxable year, the mark-to-market value of the spot and forward
contracts entered into by FC worldwide is 1000x, which includes a
mark- to-market gain of 500x with respect to the spot and forward
contracts that are shown on the books of its U.S. branch and that
produce effectively connected income. On its December 31, 1996,
determination date, FC includes 500x in its U.S. assets, and 1000x
in its worldwide assets.
Example 7. Securities in ratio as assets and liabilities. The
facts are the same as in Example 4, except that on December 31,
1996, the mark-to-market value of the spot and forward contracts
entered into by FC worldwide is 1000x, and FC has a mark-to-market
loss of 500x with respect to the spot and forward contracts that are
shown on the books of its U.S. branch and that would produce
effectively connected income. On its December 31, 1996,
determination date, FC includes the 1000x in its worldwide assets
for purposes of determining its ratio of worldwide liabilities to
worldwide assets. For purposes of Step 3, however, FC has U.S-booked
liabilities in the United States equal to the 500x U.S. loss
position.
(d) * * *
(2) * * *
(vi) Hedging transactions. A transaction (or transactions) that
hedges a U.S. booked liability, or a pool of U.S. booked liabilities,
will be taken into account in determining the currency denomination,
amount of, and interest rate associated with, that liability. A
transaction will be considered to hedge a U.S. booked liability only if
the transaction meets the requirements of Sec. 1.1221-2(a), (b), and
(c), and is identified in accordance with the requirements of
Sec. 1.1221-2(e).
* * * * *
(6) * * *
Example 4. Liability hedge--(i) Facts. FC is a foreign
corporation that meets the definition of a bank, as defined in
section 585(a)(2)(B) (without regard to the second sentence
thereof), and that is engaged in a banking business in the United
States through its branch, B. FC's corporate policy is to match the
currency denomination of its assets and liabilities, thereby
minimizing potential gains and losses from currency fluctuations.
Thus, at the close of each business day, FC enters into one or more
hedging transactions as needed to maintain a balanced currency
position, and instructs each branch to do the same. At the close of
business on December 31, 1998, B has 100x of U.S. dollar assets, and
U.S. booked liabilities of 90x U.S. dollars and 1000 x Japanese yen
(exchange rate: $1 = 100). To eliminate the currency mismatch
in this situation, B enters into a forward contract with an
unrelated third party that requires FC to pay 10x dollars in return
for 1000x yen. Through this hedging transaction, FC has effectively
converted its 1000x Japanese yen liability into a U.S. dollar
liability. FC uses its actual ratio of 90% in 1998 for Step 2, the
adjusted U.S. booked liabilities method for purposes of Step 3, and
is a calendar year taxpayer.
(ii) Analysis. Under paragraph 1.882-5(d)(2)(vi), FC is required to
take into account hedges of U.S. booked liabilities in determining the
currency denomination, amount, and interest rate associated with those
liabilities. Accordingly, FC must treat the Japanese yen liabilities
booked in the United States on December 31, 1998, as U.S. dollar
liabilities to determine both the amount of the liabilities and the
interest paid or accrued on U.S. booked liabilities for purposes of
this section. Moreover, in applying the scaling ratio prescribed in
paragraph (d)(4)(i) of this section, FC must scale back both the U.S.
booked liabilities and the hedge(s) of those liabilities. Assuming that
FC's average U.S. booked liabilities for the year ending December 31,
1998, exceed its U.S.-connected liabilities determined
[[Page 9380]]
under paragraphs (a)(1) through (c)(5) of this section by 10%, FC must
scale back by 10% both its interest expense associated with U.S. booked
liabilities, and any income or loss from the forward contract to
purchase Japanese yen that hedges its U.S. booked liabilities.
(e) * * *
(3) Hedging transactions. A transaction (or transactions) that
hedges a liability, or a pool of liabilities, will be taken into
account in determining the amount of, or interest rate associated with,
that liability. A transaction will be considered to hedge a liability
only if the transaction meets the requirements of Sec. 1.1221-2(a),
(b), and (c).
* * * * *
(5) * * *
Example 2. Asset hedge--(i) Facts. FC is a foreign corporation
that meets the definition of a bank, as defined in section
585(a)(2)(B) (without regard to the second sentence thereof), and
that is engaged in the banking business in the United States through
its branch, B. FC's corporate policy is to match the currency
denomination of its assets and liabilities, thereby minimizing
potential gains and losses from currency fluctuations. Thus, at the
close of each business day, FC enters into one or more hedging
transactions as needed to maintain a balanced currency position, and
instructs each branch to do the same. At the close of business on
December 31, 1998, B has two U.S. assets, a loan of 90x U.S. dollars
and a loan of 1000x Japanese yen (exchange rate: $1 = 100). B
has U.S. booked liabilities, however, of 100x U.S. dollars. To
eliminate the currency mismatch, B enters into a forward contract
with an unrelated third party that requires FC to pay 1000x yen in
return for 10x dollars. Through this hedging transaction, FC has
effectively converted its 1000x Japanese yen asset into a U.S.
dollar asset. FC uses its actual ratio of 90% in 1998 for Step 2,
has elected the separate currency pools method in paragraph (e) of
this section, and is a calendar year taxpayer.
(ii) Analysis. Under paragraph (e)(1)(i) of this section, FC
must take into account any transaction that hedges a U.S. asset in
determining the currency denomination and value of that asset. FC's
Japanese yen asset will therefore be treated as a U.S. dollar asset
in determining its U.S. assets in each currency. Accordingly, FC
will be treated as having only U.S. dollar assets in making its
separate currency pools computation.
(f) * * *
(2) Special rules for financial products. Paragraphs (b)(2)(iv),
(c)(2)(v), (d)(2)(vi), and (e)(3) of this section will be effective for
taxable years beginning on or after the date these regulations are
published as final regulations in the Federal Register.
Par. 3. Section 1.884-1 is amended as follows:
1. Paragraph (c)(2)(iii) is added.
2. Paragraph (d)(2) is amended as follows:
a. Paragraph (d)(2)(vii) is revised.
b. In paragraph (d)(2)(xi), Example 6 through Example 8 are added.
3. The text of paragraph (d)(6)(v) is added.
4. In paragraph (i)(4), a sentence is added at the end of the
existing text.
The revised and added provisions read as follows:
Sec. 1.884-1 Branch profits tax.
* * * * *
(c) * * *
(2) * * *
(iii) Hedging transactions. A transaction that hedges a U.S. asset,
or a pool of U.S. assets, will be taken into account in determining the
amount of that asset (or pool of assets) to the extent that income or
loss from the hedging transaction produces ECI or reduces ECI. A
transaction that hedges a U.S. asset, or pool of U.S. assets, is also
taken into account in determining the currency denomination of the U.S.
asset (or pool of U.S. assets). A transaction will be considered to
hedge a U.S. asset only if the transaction meets the requirements of
Sec. 1.1221-2(a), (b), and (c), and is identified in accordance with
the requirements of Sec. 1.1221-2(e).
(d) * * *
(2) * * *
(vii) Financial instruments. A financial instrument, including a
security as defined in section 475 and a section 1256 contract, shall
be treated as a U.S. asset of a foreign corporation in the same
proportion that the income, gain, or loss from such security is ECI for
the taxable year.
* * * * *
(xi) * * *
Example 6. Hedging transactions--(i) Facts. FC is a foreign
corporation engaged in a trade or business in the United States
through a U.S. branch. The functional currency of FC's U.S. branch
is the U.S. dollar. On January 1, 1997, in the ordinary course of
its business, the U.S. branch of FC enters into a forward contract
with an unrelated party to purchase 100 German marks (DM) on March
31, 1997, for $50. To hedge the risk of currency fluctuation on this
transaction, the U.S. branch also enters into a forward contract
with another unrelated party to sell 100 DM on March 31, 1997, for
$52, identifying this contract as a hedging transaction in
accordance with the requirements of Sec. 1.1221-2(e). FC marks its
foreign currency transactions to market for U.S. tax purposes.
(ii) Net assets. At the end of FC's taxable year, the value of
the forward contract to purchase 100 DM is marked to market,
resulting in gain of $10 being realized and recognized as U.S.
source effectively connected income by FC. Similarly, FC marks to
market the contract to sell 100 DM, resulting in $8 of realized and
recognized loss by FC. Pursuant to paragraph (c)(2)(iii) of this
section, FC must increase or decrease the amount of its U.S. assets
to take into account any transaction that hedges the contract to
purchase 100 DM. Consequently, FC has a U.S. asset of $2 ($10 (the
adjusted basis of the contract to purchase 100 DM) -$8 (the loss on
the contract to sell 100 DM)).
Example 7. Split hedge. The facts are the same as in Example 5,
except that the contract to sell 100 DM is entered into with an
unrelated third party by the home office of FC. FC includes the
contract to sell 100 DM in a pool of assets treated as producing
income effectively connected with the U.S. trade or business of FC.
Therefore, under paragraph (c)(2)(iii) of this section, at its next
determination date FC will report a U.S. asset of $2, computed as in
Example 5.
Example 8. Securities. FC is a foreign corporation engaged in a
U.S. trade or business through a branch in the United States. During
the taxable year 1997, FC derives $100 of income from securities, of
which $60 is treated as U.S. source effectively connected income
under the terms of an Advance Pricing Agreement that uses a profit
split methodology. Accordingly, pursuant to paragraph (d)(2)(vii) of
this section, FC has a U.S. asset equal to 60% ($60 of ECI divided
by $100 of gross income from securities) of the value of the
securities.
* * * * *
(6) * * *
(v) Computation of E&P basis of financial instruments. For purposes
of this section, the E&P basis of a security that is marked to market
under section 475 and a section 1256 contract shall be adjusted to take
into account gains and losses recognized by reason of section 475 or
section 1256. The E&P basis must be further adjusted to take into
account a transaction that hedges a U.S. asset, as provided in
paragraph (c)(2)(ii) of this section.
* * * * * *
(i) * * *
(4) * * * Paragraphs (c)(2)(iii), (d)(2)(vii), and (d)(6)(v) of
this section will be effective for taxable years beginning on or after
the date these regulations are published as final regulations in the
Federal Register.
* * * * *
Margaret Milner Richardson,
Commissioner of Internal Revenue.
[FR Doc. 96-5264 Filed 3-5-96; 8:45 am]
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