issue-1996-01-04•Federal Register proposed rules — 1996-01-04
Federal Register proposed rules — 1996-01-04
issue-1996-01-04Federal Register proposed rules — 1996-01-04Proposed 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. 96-65 Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); Individual Case Management
[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Proposed Rules]
[Pages 339-342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-65]
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DEPARTMENT OF DEFENSE
Office of the Secretary
32 CFR Part 199
[DoD 6010.8-R]
Civilian Health and Medical Program of the Uniformed Services
(CHAMPUS); Individual Case Management
AGENCY: Office of the Secretary, DoD.
ACTION: Proposed rule.
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SUMMARY: This proposed rule implements provisions of the 1993 National
Defense Authorization Act which allows the Secretary of Defense to
establish a case management program for CHAMPUS beneficiaries with
extraordinary medical or psychological disorders and to allow such
beneficiaries medical or psychological services, supplies, or durable
medical equipment excluded by law or regulation as a CHAMPUS benefit.
Under this program, waiver of benefit limits to the Basic CHAMPUS
program may be authorized for beneficiaries when the provision of such
services or supplies is cost effective and clinically appropriate, as
compared to historical or projected CHAMPUS/MTF utilization of health
care services. It is designed to develop a cost-effective plan of care
by targeting appropriate resources to meet the individual needs of the
beneficiary.
DATES: Written public comments must be received on or before March 4,
1996.
FOR FURTHER INFORMATION CONTACT:
CAPT Deborah Kamin, Office of the Assistant Secretary of Defense
(Health Affairs), (703)-697-8975.
SUPPLEMENTARY INFORMATION: The Civilian Health and Medical Program of
the Uniformed Services (CHAMPUS) supplements the availability of health
care in military hospitals and clinics. Case management centering on a
multidisciplinary treatment approach offers the beneficiary and
provider assurance that specific services and supplies are allowable as
CHAMPUS benefits and provides an opportunity to use those benefits
efficiently.
Statutory Authority
The case management program is based on the authority of 10 U.S.C.
1079(a)(17), which provides:
The Secretary of Defense may establish a program for the
individual case management of a person covered by this section or
section 1086 of this title who has extraordinary medical or
psychological disorders and, under such a program, may waive benefit
limitations contained in paragraphs (5) and (13) of this subsection
or section 1077(b)(1) of this title and authorize the payment for
comprehensive home health care services, supplies, and equipment if
the Secretary determines that such a waiver is cost effective and
appropriate.
Case Management
The CHAMPUS individual case management program seeks to achieve
cost effective quality health care by considering alternatives to
inpatient hospitalization and by recommending a waiver of the current
CHAMPUS benefit limits that, when provided in lieu of inpatient care
(or to prevent recurrent hospitalizations), are cost effective and
clinically appropriate. Waivers of benefit limits must be approved and
coordinated by the case manager and may include, but not be limited to
services or supplies such as home health care, medical supplies, back-
up durable medical equipment, extended skilled nursing care and home
health aides. CHAMPUS case managers will be employees or contractors of
the Department of Defense. We propose to add to section 199.4
authorization, as a case management related benefit and on a case-by-
case basis, services or supplies that would otherwise be excluded as
non-medical or duplicate durable
[[Page 340]]
equipment, custodial care, or domiciliary care. We also propose to add
definitions for waiver of benefit limits, case management, case
manager, case management multidisciplinary team, extraordinary
condition, and primary caregiver.
Eligibility
A beneficiary's eligibility for participation in the CHAMPUS case
management program is dependent on: (1) The presence of an
extraordinary medical or psychological condition which has resulted in
high utilization of CHAMPUS/MTF resources in an inpatient setting, (2)
the cost-effectiveness of providing services of supplies outside
inpatient settings, and (3) the willingness of the beneficiary to
participate, and (4) the presence of a primary caregiver in the home
when the services provided include home health care.
Role/Purpose of a Primary Caregiver
Candidates for this program will require a level of support which
cannot occur safely outside an inpatient setting unless there is a
primary caregiver in the home. Therefore, the presence of a primary
caregiver to provide services is a pre-condition of participation. We
envision that, in most cases, the role of primary caregiver will fall
to members of the beneficiary's family.
Covered Services
A list of services or supplies that may be covered as a waiver of
benefit limits will not be established. Rather, we propose that, under
the case management program, clinically appropriate services and/or
supplies may be provided when those services or supplies are cost
effective.
Custodial Care
The provision of custodial care as a waiver of benefit limits is
proposed as a transitional benefit for patients and families facing
extraordinary medical or psychological conditions. To qualify for this
waiver of benefit limits, the following conditions must be met: (1) The
patient must have been rehospitalized for exacerbations or
complications of his/her custodial condition on a recurring basis in
the prior year, (2) The proposed treatment must be cost effective when
compared to alternative treatment which would otherwise occur, (3) The
patient's condition at referral for case management is either acute or
there are indicators of a rapidly approaching acute episode, and (4)
There must be a primary caregiver.
We expect individual patients will require varying levels of
support and time to stabilize in the home environment. We propose a
maximum of 30 (thirty) days for custodial care under case management.
However, this rule would allow case managers to extend the period of
time beyond thirty days when it is considered cost effective to do so.
Prior Authorization
Prior authorization from case managers will be required before the
delivery of any case managed benefits. Because eligibility for a waiver
of benefit limits is based on an indepth assessment of medical needs,
as well as the cost effectiveness and clinical appropriateness of
alternate services, any services provided absent prior authorization
will not be covered by CHAMPUS. Retrospective requests for coverage
under this program will not be authorized.
Military Health Services System Resource Management
To ensure cost efficient as well as cost effective use of
resources, the Department of Defense will include case management
requirements, as described in this rule, in nationwide managed care
support contracts now being procured. Managed care support contractors
will be authorized to make available case management services to
Military Medical Treatment Facilities. In areas where transition to
managed care support contracts has not occurred, case management
services will be provided through existing regional peer review
organizations (Regional Review Centers, or RRCs). MTFs will be provided
the opportunity to refer potential candidates to the appropriate
CHAMPUS case manager. Where possible, Military Medical Treatment
Facilities will provide care and services or supplies in support of
regional case management programs.
Beneficiary Acknowledgment
Case management is a collaborative process among the case manager,
beneficiary, primary caregiver, and professional health care providers.
For case management to be successful, the beneficiary and primary
caregiver must participate in the process and be aware of and agree
with the requirements of the program. To document the understanding of
their roles, rights and responsibilities, a standard acknowledgment,
signed by the beneficiary (or representative) and the primary
caregiver, will be required prior to the start of case management
services.
CHAMPUS HHC/HHC-CM Demonstration
The 1986 Home Health Care and 1988 Home Health Care-Case Management
Demonstration projects were developed to test whether case management,
coupled with home health care benefits, could reduce medical costs and
improve services to CHAMPUS beneficiaries. Under the 1986
demonstration, case management services were limited to beneficiaries
who, in the absence of case managed home health care, would have
remained hospitalized. The 1988 program was less restrictive and no
longer required case management services only as a substitute for
continued hospitalization. The effectiveness of methods for identifying
potentially eligible beneficiaries and establishing the clinical
appropriateness and cost-effectiveness of services provided was
addressed by the General Accounting Office (GAO). In their report,
``DEFENSE HEALTH CARE: Further Testing and Evaluation of Case
Management Home Care Is Needed,'' the GAO identified a need for
stronger cost controls and improved targeting of potential candidates
before implementation of a permanent case management program under
CHAMPUS. While the GAO identified some weaknesses in both
demonstrations, the more restrictive design of the 1986 program was
seen as one which presented an acceptable level of risk to the
government. With the GAO's recommendations and observations in mind,
the Department is proposing a CHAMPUS case management program which is
limited to beneficiaries who would remain hospitalized in the absence
of such a program, or who have demonstrated a recent history of
multiple inpatient episodes.
Regulatory Procedures
Executive Order (EO) 12866 requires that a comprehensive regulatory
impact analysis be performed on any economically significant regulatory
action, defined as one which would result in an annual effect of $100
million or more on the national economy or which would have other
substantial impacts.
The Regulatory Flexibility Act (RFA) requires that each Federal
agency prepare, and make available for public comment, a regulatory
flexibility analysis when the agency issues a regulation which would
have a significant impact on a substantial number of small entities.
This proposed rule is a significant regulatory action under EO
12866 and has been reviewed by the Office of
[[Page 341]]
Management and Budget. In addition, we certify that this proposed rule
will not significantly affect a substantial number of small entities.
Paperwork Reduction Act
This rule, as written, imposes no burden as defined by the
Paperwork Reduction Act of 1995. If however, any program implemented
under this rule causes such a burden to be imposed, approval therefore
will be sought of the Office of Management and Budget in accordance
with the Act, prior to implementation.
List of Subjects in 32 CFR Part 199
Claims, handicapped, health insurance, and military personnel.
Accordingly, 32 CFR part 199 is proposed to be amended as follows:
PART 199--[AMENDED]
1. The authority citation for part 199 continues to read as
follows:
Authority: 5 U.S.C. 301; 10 U.S.C. chapter 55.
2. Section 199.2(b) is amended by adding new definitions in
alphabetical order:
Sec. 199.2 Definitions.
* * * * *
Case management. Case management is a collaborative process which
assesses, plans, implements, coordinates, monitors, and evaluates the
options and services required to meet an individual's health needs,
using communication and available resources to promote quality, cost
effective outcomes.
Case manager. A licensed register nurse or licensed social worker
who has a minimum of two (2) years of case management experience.
* * * * *
Extraordinary condition. A complex clinical condition which
resulted, or is expected to result, in inpatient CHAMPUS/MTF costs or
utilization above a threshold established by the Director, OCHAMPUS, or
designee.
* * * * *
Primary caregiver. An individual who renders to a beneficiary
services to support the essentials of daily living (as defined in
Sec. 199.2) and specific services essential to the safe management of
the beneficiary's condition.
* * * * *
Waiver of benefit limits. Coverage, under the Case Management
Program, of medical care, services, and or equipment not otherwise a
benefit under the Basis CHAMPUS program.
* * * * *
3. Section 199.4 is amended by adding new paragraphs (e)(20) and
(i) as follows:
Sec. 199.4 Basic program benefits.
* * * * *
(e) Special benefit information.
* * * * *
(20) Case management services. As part of case management for
beneficiaries with complex medical or psychological conditions, payment
for services or supplies not otherwise covered by the Basic CHAMPUS
program may be authorized when they are provided in accordance with
Sec. 199.4(i). Waiver of benefit limits to the basic CHAMPUS program
may be cost shared where it is demonstrated that the absence of such
services would result in the exacerbation of an existing extraordinary
condition, as defined in Sec. 199.2, to the extent that frequent or
extensive institutional services are required; and such services are a
cost effective alternative to the Basic CHAMPUS program.
* * * * *
(i) Case management program.
(1) In general. Case management, as it applies to this program,
provides a collaborative process among the case manager, beneficiary,
primary caregiver, professional health care providers and funding
sources to meet the medical needs of an individual with an
extraordinary condition. It is designed to promote quality and cost-
effective outcomes through assessment, planning, implementing,
monitoring and evaluating the options and services required. Payment
for services or supplies not otherwise covered by the basic CHAMPUS
program may be authorized when they are provided in accordance with
this paragraph (i). Waiver of benefit limits may be cost-shared where
it is demonstrated that the absence of such services would result in
the exacerbation of an existing extraordinary condition, as defined in
Sec. 199.2, to the extent that frequent or extensive hospitalizations
are required; and such services are a cost-effective alternative to the
Basic CHAMPUS program.
(2) Applicability of case management program. A CHAMPUS eligible
beneficiary may participate in the case management program if he/she
has an extraordinary condition which is disabling and requires
inpatient care at a CHAMPUS-covered level-of-care. The medical or
psychological condition must also:
(i) Be contained in the latest revision of the International
Classification of Diseases Clinical Modification, or the Diagnostic and
Statistical Manual of Mental Disorders;
(ii) Meet at least one of the following:
(A) Demonstrate a prior history of frequent, multiple inpatient
admissions, generating high CHAMPUS costs in the year immediately
preceding eligibility for the case management program; or
(B) Require clinically appropriate services or supplies from
multiple providers to address an extraordinary condition; and
(iii) More cost effectively and in a more clinically appropriate
manner be treated at a less resource intensive level of care.
(3) Prior authorization required. Services or supplies allowable as
a benefit exception under this Section shall be cost-shared only when a
beneficiary's entire treatment has received prior authorization through
an individual case management program.
(4) Cost effectiveness requirement. Treatment cost effectiveness
shall be calculated as the reduction in the cost to the Department of
Defense for proposed treatment which substitutes individual case
management services for more expensive care which would have otherwise
been reimbursed under the basic program. Generally, cost effectiveness
determinations will involve comparisons between treatments primarily
using an inpatient setting and those primarily using an outpatient or
in-home setting. Treatment must meet the requirements of appropriate
medical care as defined in Sec. 199.2.
(5) Limited waiver of exclusions and limitations. Limited waivers
of exclusions and limitations normally applicable to the basic program
may be granted for specific services or supplies only when a
beneficiary's entire treatment has received prior authorization through
the individual case management program described in this paragraph (i).
The Director, OCHAMPUS may grant a patient-specific waiver of benefit
limits for services or supplies in the following categories, subject to
the waiver requirements of this section.
(i) Durable equipment. The cost of a device or apparatus which does
not qualify as Durable Medical Equipment (as defined in Sec. 199.2) or
back-up durable medical equipment may be shared when determined by the
Director, OCHAMPUS to be cost-effective and clinically appropriate.
(ii) Custodial Care. The cost of services or supplies rendered to a
beneficiary that would otherwise be excluded as custodial care (as
defined in Sec. 199.2) may be cost-shared for a period of 30 (thirty)
days when determined by
[[Page 342]]
the Director, OCHAMPUS, to be cost effective and clinically
appropriate. To qualify for a waiver of benefit limits of custodial
care, the patient must meet all eligibility requirements of this
paragraph (i), including an acute condition or an acute exacerbation of
a chronic condition.
(A) The patient must have been rehospitalized for exacerbations or
complications of his/her custodial condition on a recurring basis in
the prior year;
(B) The proposed case management treatment must be cost effective
when compared to alternative treatment which would otherwise occur;
(C) The patient's condition at referral for case management is
either acute or there are indicators of a rapidly approaching acute
episode; and
(D) There is a primary caregiver.
(iii) Domiciliary care. The cost of services or supplies rendered
to a beneficiary that would otherwise be excluded as domiciliary care
(as defined in Sec. 199.2) may be shared when determined by the
Director, OCHAMPUS to be cost effective and clinically appropriate.
(iv) In home services. The cost of the following in-home services
may be shared when determined by the Director, OCHAMPUS to be cost
effective and clinically appropriate: nursing care, physical,
occupational, speech therapy, medical social services, intermittent or
part-time services of a home health aide, beneficiary transportation
required for treatment plan implementation, and training for the
beneficiary and primary caregiver sufficient to allow them to assume
all feasible responsibility for the care of the beneficiary that will
facilitate movement of the beneficiary to the least resource-intensive,
clinically appropriate setting. (Qualifications for home health aides
shall be based on the standards at 42 CFR 484.36.)
(v) Waiver of custodial care limits. The Director, OCHAMPUS may, in
extraordinary cases, waive the custodial care day limits described in
paragraph (e)(5)(ii) of this section and authorize this exception to
benefits beyond the 30-day limit. The criteria for waiver of the 30-day
limit shall be those set in paragraph (e)(5)(ii) of this section.
Additionally, there must be a specific determination that
discontinuation of this waiver of benefit limits will result in
immediate onset or exacerbation of an acute care episode and require
hospitalization or services or supplies which increase significantly
the cost and intensity of care.
(6) Case management acknowledgment. The beneficiary, or
representative, and the primary caregiver, shall sign a case management
acknowledgment as a prerequisite to prior authorization of case
management services. The acknowledgment shall include, in part, all of
the following provisions:
(i) The right to participate fully in the development and ongoing
assessment of the treatment;
(ii) That all health care services for which CHAMPUS cost sharing
is sought shall be authorized by the case manager prior to their
delivery;
(iii) That there are limitations in scope and duration of the
planned case management treatment, including provisions to transition
to other arrangements;
(iv) The conditions under which case management services are
provided, including the requirement that the services must be cost
effective and clinically appropriate; and
(v) That a beneficiary's participation in the case management
program shall be discontinued for any of the following reasons:
(A) The loss of CHAMPUS eligibility;
(B) A determination that the services or supplies provided are not
cost effective or clinically appropriate;
(C) The beneficiary, or representative, and/or primary caregiver,
terminates participation in writing;
(D) The beneficiary and/or primary caregiver's failure to comply
with requirements in this paragraph (i); or
(E) A determination that the beneficiary's condition no longer
meets the requirements of participation as described in this paragraph
(i).
(7) Other administrative requirements.
(i) Qualified providers of services or items not covered under the
basic program, or who are not otherwise eligible for CHAMPUS-authorized
status, may be authorized for a time-limited period when such
authorization is essential to implement the planned treatment under
case management. Such providers must not be excluded or suspended as a
CHAMPUS provider, and must agree to participate on all claims related
to the case management treatment.
(ii) Retrospective requests for authorization of waiver of benefit
limits will not be considered. Authorization of waiver of benefit
limits is allowed only after all other options for services or supplies
have been considered and either appropriately utilized or determined to
be clinically inappropriate and/or not cost-effective.
(iii) Experimental or investigational treatment or procedures shall
not be cost-shared as an exception to standard benefits under this
part.
(iv) CHAMPUS case management services may be provided by
contractors designated by the Director, OCHAMPUS.
Dated: December 28, 1995.
L.M. Bynum,
Alternate OSD Federal Register Liaison Officer, Department of Defense.
[FR Doc. 96-65 Filed 1-3-96; 8:45 am]
BILLING CODE 5000-04-M
Complete official Federal Register PDF
FR Doc. 96-29 Food Labeling: Health Claims; Oats and Coronary Heart Disease
[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Proposed Rules]
[Pages 295-337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-29]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 95P-0197]
RIN 0910-AA19
Food Labeling: Health Claims; Oats and Coronary Heart Disease
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to
authorize the use, on food labels and in food labeling, of health
claims on the association between oat products, i.e., oat bran and
oatmeal, and reduced risk of coronary heart disease (CHD). FDA is
proposing this action in response to a petition filed by the Quaker
Oats Co. (the petitioner). The agency has tentatively concluded that,
based on the totality of publicly available scientific evidence, diets
high in oatmeal and oat bran and low in saturated fat and cholesterol
may reduce the risk of CHD.
DATES: Written comments by April 3, 1996. The agency is proposing that
any final rule that may issue based upon this proposal become effective
upon its publication in the Federal Register.
ADDRESSES: 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:
Joyce J. Saltsman, Center for Food Safety and Applied Nutrition (HFS-
165), Food and Drug Administration, 200 C St. SW., Washington, DC
20204, 202-205-5916.
SUPPLEMENTARY INFORMATION:
I. Background
A. The Nutrition Labeling and Education Act of 1990
On November 8, 1990, the President signed into law the Nutrition
Labeling and Education Act of 1990 (the 1990 amendments) (Pub. L. 101-
535). This new law amended the Federal Food, Drug, and Cosmetic Act
(the act) in a number of important ways. One of the most notable
aspects of the 1990 amendments was that they confirmed FDA's authority
to regulate health claims on food labels and in food labeling. As
amended by the 1990 amendments, section 403(r)(1)(B) of the act (21
U.S.C. 343(r)(1)(B)) provides that a product is misbranded if it bears
a claim that characterizes the relationship of a nutrient to a disease
or health-related condition, unless the claim is made in accordance
with the procedures and standards contained in regulations adopted by
FDA.
Under section 403(r)(3)(B)(i) of the act, the Secretary of Health
and Human Services (and, by delegation, FDA) shall issue regulations
authorizing such claims only if he or she determines, based on the
totality of publicly available scientific evidence (including evidence
from well-designed studies conducted in a manner which is consistent
with generally recognized scientific procedures and principles), that
there is significant scientific agreement, among experts qualified by
scientific training and experience to evaluate such claims, that the
claim is supported by such evidence.
Sections 403(r)(3)(B)(ii) and (r)(3)(B)(iii) of the act describe
the information that must be included in any claim authorized under the
act. The act provides that the claim shall be an accurate
representation of the significance of the substance in affecting the
disease or health-related condition, and that it shall enable the
public to comprehend the information and understand its significance in
the context of the total daily diet. Finally, section 403(r)(4)(A)(i)
of the act provides that any person may petition FDA to issue a
regulation authorizing a health claim.
The 1990 amendments, in addition to amending the act, directed FDA
to consider 10 substance-disease relationships as possible subjects of
health claims. One of the 10 substance- disease relationships was the
relationship between dietary fiber and cardiovascular disease (CVD) (58
FR 2552, January 6, 1993) (hereinafter referred to as the 1993 dietary
fiber and CVD final rule).
B. FDA's Response
In the Federal Register of January 6, 1993 (58 FR 2478), FDA
adopted a final rule that implemented the health claim provisions of
the act (hereinafter referred to as the 1993 health claims final rule).
In that final rule, FDA adopted Sec. 101.14 (21 CFR 101.14), which sets
out the circumstances in which a substance is eligible to be the
subject of a health claim (Sec. 101.14(b)), adopts the standard in
section 403(r)(3)(B)(i) of the act as the standard that the agency will
apply in deciding whether to authorize a claim about a substance-
disease relationship (Sec. 101.14(c)), sets forth general rules on how
authorized claims are to be made in food labeling (Sec. 101.14(d)), and
establishes limitations on the circumstances in which claims can be
made (Sec. 101.14(e)). The agency also adopted Sec. 101.70 (21 CFR
101.70), which establishes a process for petitioning the agency to
authorize health claims about a substance-disease relationship
(Sec. 101.70(a)) and sets out the types of information that any such
petition must include (Sec. 101.70(d)). These regulations became
effective on May 8, 1993.
In addition, FDA conducted an extensive review of the evidence on
the 10 substance-disease relationships listed in the 1990 amendments.
As a result of its review, FDA has authorized claims that relate to 8
of these 10 relationships. While the agency denied the use on food
labeling of health claims relating dietary fiber to reduced risk of CVD
(58 FR 2552), it authorized a health claim relating diets low in
saturated fat and cholesterol and high in fruits, vegetables, and grain
products that contain dietary fiber (particularly soluble fiber) to a
reduced risk of CHD, the most common, most frequently reported, and
most serious form of CVD.
In denying the dietary fiber and CVD health claim, the agency
stated that a problem in determining whether there is a relationship
between dietary fiber and heart disease is presented by the fact that
dietary fiber is a diverse group of chemical substances that may be
associated with different physiological functions (58 FR 2552 at 2572).
Chemically and physiologically, cellulose, lignin, hemicellulose,
pectin, and alginate (all relatively purified fiber types) behave
differently. Wheat bran, oat bran, and rice bran (all heterogeneous
mixtures of fibers) are not similar in composition. The agency also
noted that it is very difficult to chemically analyze dietary fiber
components, and that it is consequently hard to correlate the role of
specific fiber components to health effects.
Based on its review of numerous authoritative documents, including
Federal government reports and recent research on dietary fiber and
CHD, and on its consideration of comments received in response to its
``Health Claims; Dietary Fiber and Cardiovascular Disease'' proposed
rule (56 FR 60582, November 27, 1991) (hereinafter referred to as the
1991 dietary fiber and CVD proposal), FDA concluded that the publicly
available scientific evidence supports an association between diets low
in saturated fat and cholesterol and high in fruits, vegetables, and
grain products, foods that are low in saturated fat and cholesterol and
that are good sources of dietary fiber, and reduced risk of heart
disease (58 FR 2552 at 2572). The
[[Page 297]]
agency further stated that, although the specific roles of the numerous
potentially protective substances in such plant foods are not yet
understood, populations with diets rich in these foods experience many
health advantages, including lower rates of heart disease. The agency
noted, however, that there was no scientific agreement as to whether
the observed protective effects against heart disease are the result of
a combination of nutrient components of the foods, including soluble
fiber; of the other components of soluble fiber-rich diets (for
example, potassium and magnesium); of the displacement of saturated fat
and cholesterol from the diet; or of non-nutritive substances in these
foods. For all these reasons, the agency stated that the fact that
these foods contain dietary fiber, particularly soluble fiber, can
serve as a useful marker for identifying those fruits, vegetables, and
grain products that, when added to diets low in saturated fat and
cholesterol, may help in reducing blood LDL-cholesterol levels (58 FR
2552 at 2572). Thus, the agency authorized a health claim in
Sec. 101.77 (21 CFR 101.77) on the association between diets low in
saturated fat and cholesterol and high in vegetables, fruit, and grain
products that contain soluble fiber and a reduced risk of heart
disease.
In the 1993 dietary fiber and CVD final rule, in response to a
comment regarding the apparent hypocholesterolemic properties of
specific food fibers, e.g., oats, FDA agreed that the effectiveness of
naturally occurring fibers in foods may be documented for specific food
products (e.g., oat brans meeting specified parameters) (58 FR 2552 at
2567). Further, the agency stated that if manufacturers can document,
through appropriate studies, that dietary consumption of the soluble
fiber in their particular food has the effect of lowering low density
lipoprotein cholesterol (LDL)-cholesterol, and has no adverse effects
on other heart disease risk factors (e.g., high density lipoprotein
(HDL)-cholesterol), they should petition for a health claim for their
particular product.
The present rulemaking is in response to a manufacturer's health
claim petition on the relationship between a specific fiber-containing
food, oats, and heart disease.
II. Petition for Oat Products and Reduced Risk of CHD
A. Background
On March 22, 1995, the Quaker Oats Co. submitted a health claim
petition to FDA requesting that the agency authorize a health claim on
the relationship between consumption of oat products and the risk of
CHD (Ref. 1). On June 29, 1995, the agency sent the petitioners a
letter stating that it had completed its initial review of the
petition, and that the petition would be filed in accordance with
section 403(r)(4) of the act (Ref. 2). In this document, the agency
will consider whether a health claim on this food-disease relationship
is justified under the standard in section 403(r)(3)(B)(i) of the act
and Sec. 101.14(c) of FDA's regulations. The following is a review of
the health claim petition.
B. Preliminary Requirements
1. The Substances Are Associated With a Disease for Which the U.S.
Population Is at Risk
CHD remains a major public health problem and the number one cause
of death in the United States. Despite the decline in deaths from CHD
over the past 30 years, this disease is still exacting a tremendous
toll in morbidity and mortality (Refs. 3 and 4). There are more than
500,000 deaths each year for which CHD is an underlying cause, and
another 250,000 deaths for which CHD is a contributing cause. About 20
percent of adults (male and female; black and white) ages 20 to 74
years have blood total cholesterol (or serum cholesterol) levels in the
``high risk'' category (total cholesterol greater than (>) 240
milligrams (mg) per (/) deciliter (dL) and LDL-cholesterol greater than
160 mg/dL) (Ref. 47). Another 31 percent have ``borderline high''
cholesterol levels (total cholesterol between 200 and 239 mg/dL and
LDL-cholesterol between 130 and 159 mg/dL) in combination with two or
more risk factors.
CHD has a significant effect on health-care costs. In 1985, total
direct costs related to CHD were estimated at $13 billion, and indirect
costs from loss of productivity due to illness, disability, and
premature deaths from this disease were an estimated $36 billion (Ref.
3).
Based on these facts, FDA concludes that, as required in
Sec. 101.14(b)(1), CHD is a disease for which the U.S. population is at
risk.
2. The Substances Are Food
Oatmeal and oat bran are foods and are used as ingredients in other
foods. These oat products contribute taste, aroma, or nutritive value
that are retained when consumed at levels necessary to justify the
petitioned claim.
Therefore, FDA tentatively concludes that these substances satisfy
the preliminary requirements of Sec. 101.14(b)(3)(i).
3. The Substances Are Safe
Oatmeal and oat bran are safe and lawful under the act. Both
substances have a long history of use as food and food ingredients and
are generally recognized as safe under Sec. 170.30(d) (21 CFR
170.30(d)).
Thus, FDA tentatively concludes that the petitioner has satisfied
the requirement of Sec. 101.14(b)(3)(ii).
III. Review of Scientific Evidence
A. Basis for Evaluating the Relationship Between Oats and CHD
In the 1991 dietary fiber and CVD proposal, the agency set forth
the basis of the relationship between dietary fiber and CVD (56 FR
60582 at 60583). In that document, the agency stated that there are
many risk factors that contribute to the development of CVD, and
specifically CHD, the most serious form of CVD and the leading cause of
disability. The agency also stated that there is general agreement that
elevated blood cholesterol levels are one of the major ``modifiable''
risk factors in the development of CVD and, more specifically, CHD. The
Federal government and other reviews have concluded that there is
substantial epidemiologic and clinical evidence that high blood levels
of total cholesterol and LDL-cholesterol are a cause of atherosclerosis
(inadequate circulation of blood to the heart due to narrowing of the
arteries) and represent major contributors to CHD (56 FR 60727 at
60728, November 27, 1991; Refs. 3 through 6). Factors that decrease
total cholesterol and LDL-cholesterol will also tend to decrease the
risk of CHD. High intakes of saturated fat and, to a lesser degree, of
dietary cholesterol are associated with elevated blood total and LDL-
cholesterol levels (56 FR 60727 at 60728). Thus, it is generally
accepted that total cholesterol and LDL-cholesterol levels can predict
the risk of developing CHD, and that dietary factors affecting blood
total cholesterol levels affect the risk of CHD (Refs. 3 through 6).
When considering the effect that the diet or components of the diet
have on blood (or serum) lipids, it is also important to consider the
effect that these factors may have on blood levels of HDL-cholesterol.
Evidence from epidemiologic studies show that elevated levels of HDL-
cholesterol are inversely related to the incidence of atherosclerosis
and thus CHD (Ref. 3). HDL- cholesterol is involved in the regulation
of cholesterol transport out of
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cells and to the liver from which it is ultimately excreted (Refs. 3
and 48). Therefore, HDL-cholesterol has a protective effect in the body
by helping to lower total cholesterol. Dietary factors that help to
significantly lower total cholesterol should, themselves, not have an
adverse affect on the level of HDL-cholesterol.
For these reasons, FDA limited its review of the relationship
between oatmeal and oat bran and CHD to effects of these food
components on blood lipid levels and on the risk of developing CHD. The
agency based its evaluation of this relationship on changes in total
blood and LDL-cholesterol from dietary intervention with oatmeal and
oat bran and with oat- containing products. This focus is consistent
with that used by the agency in response to the 1990 amendments in
deciding on the dietary saturated fat and cholesterol and CHD health
claim (Sec. 101.75) (56 FR 60727 and 58 FR 2739, January 6, 1993) and
the fruits, vegetables, and grain products and CHD claim (Sec. 101.77)
(56 FR 60582 and 58 FR 2552).
B. Review of Scientific Evidence
1. Evidence Considered in Reaching the Decision
The petitioner submitted scientific studies evaluating the
relationship between oat bran and oatmeal, consumed as foods and as
ingredients in foods, and serum lipid levels (Ref. 1). These studies
were conducted between 1980 and 1995. The petition included a review of
these studies and a summary of the evidence. Most of the studies that
were published before 1993 had been reviewed by the agency in the
proposed and final rules on dietary fiber and CVD (56 FR 60582 at 60596
and 58 FR 2552 at 2581). A review of the studies evaluating the effect
of oat products on blood lipids submitted by the petitioner, including
those previously reviewed by the agency, is provided in Table 1. In
addition, in its review of the petition, the agency considered the
conclusions of the Life Sciences Research Office (LSRO) of the
Federation of American Societies for Experimental Biology (FASEB) (Ref.
7) relative to studies involving oats.
2. Criteria for Selection of Human Studies
The criteria that the agency used to select pertinent studies were
that the studies: (1) Present data and adequate descriptions of the
study design and methods; (2) be available in English; (3) include
estimates, or enough information to estimate, soluble dietary fiber
intakes; (4) include direct measurement of blood total cholesterol and
other blood lipids related to CHD; and (5) be conducted in persons who
represent the general U.S. population (adults with blood total
cholesterol levels less than (<) 300 mg/dL).
In selecting human for review, the agency excluded studies that
were published in abstract form because they lacked sufficient detail
on study design and methodologies, and because they lacked necessary
primary data. Studies using special population groups, such as insulin-
dependent diabetics, individuals with very high serum cholesterol (mean
greater than 300 mg/dL), children with hypercholesterolemia, and
persons who had already experienced a myocardial infarction, were also
generally not weighed heavily because of questions about their
relevance to the general healthy U.S. population.
3. Criteria for Evaluating the Relationship Between Oat Products and
CHD
FDA applied the same criteria in evaluating the relationship
between oat products and CHD that it did in evaluating the relationship
between dietary fiber and CVD in the 1991 dietary fiber and
cardiovascular disease proposal (56 FR 60582 at 60587). The criteria
that the agency used in evaluating these studies included: (1)
Reliability and accuracy of the methods used in nutrient intake
analysis, including measurements of total dietary soluble fiber and
total dietary fiber; (2) available information on the soluble fiber or
beta-glucan (-glucan, the predominant soluble fiber in oats)
content of the oat products and control food; (3) measurement of study
endpoints (i.e., total cholesterol, LDL-cholesterol, and HDL-
cholesterol); and (4) general study design characteristics. The
characteristics of general study design included randomization of
subjects, appropriateness of controls, selection criteria for subjects,
attrition rates (including reasons for attrition), potential for
misclassification of individuals with regard to dietary intakes,
presence of recall bias and interviewer bias, recognition and control
of confounding factors (for example, intake of saturated fat and other
nutrients, monitoring body weight, and control of weight loss),
appropriateness of statistical tests and comparisons, and statistical
power of the studies. The agency considered whether the intervention
studies that it evaluated had been of long enough duration to
reasonably ensure stabilization of blood lipids (greater than or equal
to 3 weeks duration). Finally, the agency considered it highly
desirable if the available information on a study included information
on the total dietary fiber and total dietary soluble fiber content of
baseline, treatment, and control diets and on the nutrient intakes of
the subjects during the course of the study.
As stated above, dietary saturated fat and cholesterol affect blood
lipid levels (Refs. 4 through 6). Previous reviewers have generally
concluded that, in persons with relatively higher baseline levels of
blood cholesterol, responses to treatment tend to be of a larger
magnitude than is seen in persons with more normal blood cholesterol
levels (56 FR 60582 at 60587 and Refs. 4 through 6). To take into
account these factors, FDA separately evaluated studies on mildly to
moderately hypercholesterolemic individuals (persons with elevated
blood total cholesterol levels of 200 to 300 mg/dL) and studies on
normocholesterolemic individuals (persons with normal blood total
cholesterol levels (< 200 mg/dL)). FDA also separately evaluated
studies in which oat products' effects were evaluated as part of a
``typical'' American diet (approximately 37 percent of calories from
fat, 13 percent of calories from saturated fat, and more than 300 mg of
cholesterol daily) and studies in which the test protocols incorporated
a Step I or similar (e.g., American Heart Association (AHA)) dietary
regimen (less than 30 percent of calories from fat, less than 10
percent of calories from saturated fat, and less than 300 mg of
cholesterol daily). Moreover, to ensure that results were not
reflective of transient changes, such as failure of blood cholesterol
levels to stabilize to the dramatic changes in dietary patterns that
occur with the introduction of large amounts of test substances, FDA
gave less weight to studies with treatment periods of less than 3 weeks
than it gave to studies of longer duration.
C. Summary of Human Studies
FDA's review of the 37 human studies on oat bran and oatmeal and
serum cholesterol (Refs. 8 through 32, 34 through 39, and 41 through
46) that were submitted with the petition is summarized in detail in
Table 1. The results of a metaanalysis (Ref. 33) that included a number
of the oat studies is discussed in section III.C.5. of this document.
1. Hypercholesterolemics: ``Typical'' or ``Usual'' Diets
Eight of the studies (Refs. 8, 12, 20, 21, 25, 35, 44, and 45) show
a relationship between consumption of oat products and reduced serum
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cholesterol in hypercholesterolemic subjects consuming a typical
American diet. Anderson et al. (Ref. 8) in a metabolic ward study
reported significantly lower total (12.8 percent) and LDL-cholesterol
(12.1 percent) in male subjects consuming 110 grams (g) (7.6 g soluble
fiber, 13.4 g total dietary soluble fiber) oat bran for 21 days (d). A
wheat group, which consumed 40 g of wheat bran (1.3 g soluble fiber,
7.8 g total dietary soluble fiber), experienced nonsignificant
decreases in total (4.4 percent) and LDL-cholesterol (5.5 percent).
There was no significant change in HDL-cholesterol in either group.
Both groups experienced a significant decrease in weight (1 kilogram
(kg)) compared to their mean baseline weight values. There was no
difference in weight loss between the oat and wheat groups.
Braaten et al. (Ref. 12) evaluated the effects on blood cholesterol
levels of instant oat gum (7.2 g; 5.8 g -glucan), an extract
of oat bran comprised of almost entirely -glucan soluble fiber
plus some trace elements, or a placebo (maltodextrin) when mixed with a
noncarbonated diet fruit drink (250 milliliters (mL)) and consumed
twice a day at each main meal for 4 weeks by hypercholesterolemic
subjects. Results showed significantly lower total cholesterol by 9.2
percent (p<0.0001) and LDL-cholesterol by 10 percent (p<0.001) in the
oat gum group compared to baseline.
Hegsted et al. (Ref. 20) evaluated the hypocholesterolemic
properties of rice bran and oat bran in hypercholesterolemic subjects.
Using a cross-over design, subjects consumed treatment diets providing
100 g/d of rice bran and oat bran for 3-week periods each. A control
diet, which consisted of the treatment diet but with wheat flour and no
bran, was consumed for 2 weeks before each bran period. The results
showed significant reductions in total cholesterol with both the rice
and oat bran diets compared to the control diet (p<0.001). During the
two oat test periods, serum cholesterol was reduced about 10 percent
(phase 1) and 4 percent (phase 2) compared to serum cholesterol values
during the control period. Oat bran intervention also resulted in
significant reductions (about 13 percent in phase 1 and about 7 percent
in phase 2) in LDL-cholesterol. Rice bran was as effective in lowering
serum cholesterol as oat bran.
Kahn et al. (Ref. 21) evaluated the hypocholesterolemic properties
of four oat bran muffins/d (80 g total daily oat bran) in
hypercholesterolemic subjects randomized into immediate oat bran
intervention and delayed oat bran intervention groups. The delayed oat
bran intervention group served as the control group. After correcting
for the time delay of the study, the results showed that oat bran
dietary intervention significantly reduced total cholesterol by almost
8 percent (p<0.02), LDL-cholesterol by about 10 percent (p<0.02), and
HDL-cholesterol by almost 1 percent (p<0.03) from baseline.
Kestin et al. (Ref. 25) reported decreased levels of total
cholesterol (4.9 percent) and LDL-cholesterol (6.8 percent) in
hypercholesterolemic subjects consuming 95 g/d (5.8 g soluble fiber)
oat bran. These values were significantly lower than those observed in
subjects consuming rice bran (p<0.01) and wheat bran (p<0.001). HDL-
cholesterol increased in all groups. The oat bran was incorporated into
bread and muffins.
Spiller et al. (Ref. 35) reported significantly lower total
cholesterol (3.7 percent) and LDL-cholesterol (6.6 percent), and a
nonsignificant increase in HDL-cholesterol (1 percent), in
hypercholesterolemic subjects consuming 77 g/d (5 g soluble fiber) oat
bran. Changes in total cholesterol were experienced within the first 14
days with no significant changes occurring between days 14 and 21 of
the study. The oat bran was mixed with water and consumed before meals.
The calories provided by the oat bran replaced about an equal amount of
carbohydrate calories in the subjects' diets.
Whyte et al. (Ref. 45) reported decreases in total cholesterol of
3.1 percent (p<0.01) and LDL-cholesterol of 5.7 percent (p<0.01)
compared to baseline values after hypercholesterolemic subjects
consumed 123 g (10.3 g soluble fiber) oat bran/day for 4 weeks. The oat
bran was consumed as a breakfast cereal. Consumption of total fat and
saturated fat remained the same during the test period.
Van Horn et al. (Ref. 44) reported reductions in total cholesterol
(about 6.2 percent) and LDL-cholesterol (9.2 percent) levels, compared
to a control group, in subjects consuming 57 g of instant oats daily
for 8 weeks. The control group experienced decreases in total
cholesterol and LDL-cholesterol of 1.4 percent and 3.7 percent,
respectively. The differences between the oat and control groups were
significant (p<0.05). The authors reported greater reductions in total
cholesterol in those individuals who had a baseline cholesterol level
above the baseline median cholesterol level of 243 mg/dL. The authors
also reported significantly different dietary intakes after 4 weeks of
intervention for a number of nutrients in the oat group's diet compared
to that of the control group. After 4 weeks of intervention, the oat
group had higher intakes of soluble and total fiber and lower intakes
of saturated fat and cholesterol. A metaanalysis conducted by Ripsin et
al. (Ref. 33), which is discussed in section III.C.5. of this document,
evidences that the changes in dietary fats and cholesterol intake in
this study did not appear to be responsible for the drop in serum
cholesterol levels, thus suggesting that oat bran and oatmeal were
responsible for the observed effect.
Results of four studies (Refs. 18, 26, 34, and 38) were
inconclusive regarding the relationship between oat bran or oatmeal
consumption and reduced serum lipids. Gormley et al. (Ref. 18) reported
no effect of oatmeal porridge on serum cholesterol or HDL-cholesterol
in hypercholesterolemic men and normocholesterolemic women. The authors
stated that dietary intakes were monitored, but the subjects' dietary
intakes were not reported. The amount of total dietary fiber and
soluble fiber in the total diet and oatmeal porridge were not provided.
Insufficient dietary controls make the results of this study difficult
to interpret.
Leadbetter et al. (Ref. 26) reported no significant effect of
increasing intakes of -glucan from oat bran on serum
cholesterol in 40 hypercholesterolemic men and women. Subjects consumed
0, 30, 60, or 90 g oat bran/day for 1-month intervals. The authors
stated that the New Zealand oats used in this study were lower in
soluble fiber (3.7 to 4.2 percent -glucan) than oat bran used
in studies that showed a significant lowering of serum cholesterol with
oat bran supplementation.
Saudia et al. (Ref. 34) reported no significant difference in serum
cholesterol levels in hypercholesterolemic subjects consuming oat bran
daily for 93 days. The subjects consumed 3 ounces (oz) (about 84 g) of
oat bran daily with their usual diet for 3 months. The subjects' total
dietary intake, including their intake of total and saturated fat and
cholesterol, before and during the trial were not reported. The authors
stated that the subjects may have changed their diets during the test
period because the study took place over summer months and because of
an increased awareness by the subjects of risk-reducing behavior and
lifestyles. The study also lacked a control group, thus making the
results of this study difficult to interpret.
Torronen et al. (Ref. 38) showed small reductions in serum
cholesterol, LDL-, and HDL-cholesterol in an oat bran
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group compared to baseline, but these reductions were not statistically
significant. An oat bran concentrate was prepared and incorporated into
a loaf of bread (11.2 g -glucan per loaf). A control bread was
made with wheat flour. The use of oat bran concentrate in this study
does not provide evidence for an effect of oat bran per se on serum
cholesterol because the authors state that the method of concentrating
and processing the oat bran and -glucan may have affected the
effectiveness of the -glucan in lowering serum cholesterol.
Animal studies by these authors confirmed that the method of producing
the oat bran concentrate produced significantly weaker
hypocholesterolemic responses than untreated oat bran or concentrates
with higher viscosities.
One study (Ref. 32) showed equivocal results in reducing total
cholesterol. Poulter and coworkers reported small but significant
reductions in serum cholesterol and LDL-cholesterol in
hypercholesterolemic subjects consuming 50 g of oat cereal compared to
subjects consuming the same amount of cereal without oats. Subjects
with baseline cholesterol values greater than 231 mg/dL experienced the
most significant reduction in serum cholesterol. However, the results
of this study are difficult to interpret because some subjects made
changes in their diets after starting the trial. There was a
significant reduction in total energy from fat compared to baseline
intakes. Similarly, the ratio of polyunsaturated fat to saturated fat
in the subjects' diet also fell significantly during the oat period.
2. Hypercholesterolemics: Low Fat Diets
Results of six studies (Refs. 11, 15, 23, 24, 39, and 43) showed a
cholesterol reducing effect of oatmeal or oat bran in
hypercholesterolemic subjects who consumed the oat products as part of
a low fat diet. Beling et al. (Ref. 11) divided the subjects into 3
groups. Group 1 consumed their regular (not fat modified) diet. Groups
2 and 3 consumed an AHA fat modified diet. There were significantly
lower total and LDL-cholesterol levels after 4 weeks in groups 2 and 3.
In groups 2 and 3, total cholesterol decreased by 10 percent and 11.8
percent, and LDL-cholesterol decreased by 11.5 percent and 11.8
percent, respectively. From weeks 5 to 8, group 2 continued on the AHA
diet, while group 3 consumed the AHA diet plus 56 g oat bran cereal/
day. At the end of week 8, total cholesterol had decreased by 2.3
percent, 8.4 percent, and 12.2 percent from baseline levels for groups
1, 2, and 3, respectively. The mean total cholesterol level of the oat
group was significantly different from the control group and the group
that consumed only the AHA diet (p<0.05). At week 8, LDL-cholesterol
levels were 10.1 percent below baseline for group 2 and 14.9 percent
below baseline for group 3 (p<0.05). HDL-cholesterol decreased 1
percent, 3 percent, and 8 percent in groups 1, 2, and 3, respectively,
at 8 weeks. The differences in HDL-cholesterol between the 3 groups
were not significant. The differences in HDL-cholesterol in groups 2
and 3 were significantly different from the control (p<.05). Groups 2
and 3 experienced weight loss, but the differences between these groups
were not significant.
Davidson et al. (Ref. 15) evaluated the hypocholesterolemic effects
of increasing amounts of -glucan from oat bran and oatmeal in
hypercholesterolemic subjects consuming a Step 1 diet. The results
showed that groups consuming diets containing 3 g/d or more of
-glucan experienced significant declines in blood total
cholesterol (7 to 10 percent) and LDL-cholesterol (10 to 16 percent)
compared to baseline. Blood total cholesterol levels of groups
consuming diets containing 1 to 2.4 g daily of -glucan did not
differ significantly from baseline.
Turnbull and Leeds (Ref. 39) evaluated the effects of oats and
wheat on total cholesterol in hypercholesterolemic subjects consuming a
low fat diet. During a 1-month run-in period (baseline), the subjects
consumed the low fat diet alone and experienced a 7.6 percent (not
significant) reduction in total cholesterol. The subjects were then
randomized to receive 150 g/d of oats or wheat while consuming the low
fat diet for another month. At the end of the month, subjects crossed
over to the other grain supplement. The results of this study showed
that during the oat period, subjects experienced significant reductions
in total cholesterol (p<0.03) and LDL-cholesterol (p<0.002) compared to
baseline despite an increase in energy and total fat intake. There were
no significant changes in total cholesterol and LDL-cholesterol when
subjects consumed the wheat diet. HDL-cholesterol showed a
nonsignificant increase from baseline during the oat period and no
change during the wheat period.
In a large, controlled clinical trial, Van Horn et al. (Ref. 43)
instructed moderately hypercholesterolemic subjects (mean total
cholesterol of 208 mg/dL) on the AHA low fat diet. The subjects
consumed the AHA diet alone for 6 weeks, during which time they
experienced significantly reduced total cholesterol compared to
baseline. The subjects were then randomized to one of 3 groups: two oat
groups (2 oz of oat bran or oatmeal daily) or the control group (AHA
diet only) for another 6 weeks. At the end of the intervention period,
subjects consuming 56 g of oat bran and oatmeal had total cholesterol
values 8 percent and 9.3 percent lower than baseline, respectively. The
control group experienced a 4.5 percent reduction in serum cholesterol.
At the end of the study, the differences in total cholesterol levels
for all three groups compared to baseline levels were statistically
significant (p<0.05), but there was no significant difference between
the oat groups and the control. Both the oat bran and the oatmeal
groups experienced a modest (3 percent) reduction in serum cholesterol
beyond that achieved by the low fat diet alone.
The modest effect of oat bran and oatmeal on serum cholesterol in
this study may have been affected by the subjects' cholesterol levels
before dietary intervention. The subjects' mean cholesterol level was
208.4 mg/dL. After dietary intervention, the mean cholesterol levels
were 201 mg/dL (control), 196.4 mg/dL (oat bran group), and 195.2 mg/dL
(oatmeal group). Studies have shown that subjects with higher initial
blood cholesterol levels usually experience the most reduction in total
cholesterol from oat intervention (Refs. 6 and 33). Thus, because of
the subjects' relatively low cholesterol levels at the initiation of
the oats intervention period, the differences among the groups may have
been minimized.
Keenan et al. (Ref. 23) reported variable responses in serum lipids
depending on the order of feeding of the diets supplemented with 56 g
of oat bran or wheat cereal during an 18-week double-blind study with
crossover. Subjects consumed a Step 1 diet during the first period (6
weeks) and then were randomized to 1 of 3 groups. The control group
consumed a Step 1 diet for another 12 weeks. The two test groups
consumed wheat cereal or oat cereal for 6 weeks before crossover to the
other test cereal for another 6 weeks. Interpretation of results was
complicated by the fact that the control group showed an initial
decline in blood cholesterol levels followed by a return to baseline at
the end of the study. Only the oat groups maintained reduced serum
cholesterol and LDL-cholesterol throughout the test periods. When
compared to the control and wheat groups, these reductions were
significant (p<.01).
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Kelley et al. (Ref. 24) reported significantly reduced serum
cholesterol (p<0.04) and LDL-cholesterol (p<0.05) at the end of 4 weeks
in subjects who were participating in a program of supervised aerobic
exercises. The subjects consumed about 94 g of oat bran daily as part
of their usual low fat, low saturated fat diets. This study lacked an
appropriate placebo control.
Six studies (Refs. 13, 16, 27, 28, 36, and 41) gave inconclusive
results regarding the relationship between oat consumption and reduced
serum lipids in hypercholesterolemic subjects consuming low fat diets.
In a study by Bremer et al. (Ref. 13), subjects consumed either oat or
wheat bread (about 8 slices/day) in place of other carbohydrate foods
as part of their AHA phase II diet (total fat 25 to 30 percent of
energy, saturated fat <8 percent of energy, polyunsaturated fat 5 to 10
percent of energy, cholesterol <250 mg/day). Subjects had a mean intake
of 44.6 g/day of oat bran (range of 34.2 to 68.4 g/day). The study
showed no significant differences in total serum cholesterol or LDL-
cholesterol between the period in which the subjects consumed oat bread
and the period in which they consumed wheat bread. However, the lack of
an observed effect on serum cholesterol from oat bran could be
attributable to the lower soluble fiber content of the New Zealand oat
bran used in this study compared to oat bran used in other studies.
Demark-Wahnefried et al. (Ref. 16) evaluated the
hypocholesterolemic properties of oat bran in hypercholesterolemic
subjects following one of four dietary protocols for 12 weeks: Step 1
diet alone, Step 1 diet plus added soluble fiber from 50 g of oat bran,
regular diet plus 50 g of oat bran, and regular diet plus 42 g of
processed oat bran. The results of this study showed significant
reductions (p<0.05) in serum cholesterol in all diet groups. The serum
cholesterol levels of groups consuming diets containing the higher
soluble fiber (approximately 4 g added soluble fiber daily) did not
differ from groups on a dietary regimen modified only in fat and
cholesterol content. Variable weight loss was reported among the
groups, and dietary changes in all groups confound the results of this
study.
In a study by Lepre and Crane (Ref. 27), subjects received a
prescribed low fat diet for 8 weeks before being randomly assigned to
either the oat or wheat group. Subjects consumed 2 oat bran muffins (60
g of oat bran, 3.2 g soluble fiber) or 2 wheat bran muffins (60 g wheat
bran) daily for 8 weeks. At the end of the first 8-week test period,
subjects crossed over to the other test group for another 8 weeks. The
results showed small, nonsignificant reductions in serum cholesterol
(2.2 percent) and LDL-cholesterol (3.1 percent) and a nonsignificant
increase in HDL-cholesterol (3.0 percent) during the oat bran period
compared to diet only period. During the wheat bran period, there was a
nonsignificant increase in total cholesterol, LDL-cholesterol, and the
ratio of LDL- to HDL-cholesterol (LDL:HDL) and a nonsignificant
decrease in HDL-cholesterol. The results of this study were confounded
because subjects made significant dietary changes during the diet only
and the oat bran periods. The subjects were aware of their
hyperlipidemias and were already on a low fat diet before the start of
this study. They also knew in advance which days they were required to
record their dietary intake. The intakes of dietary cholesterol and
saturated fat were significantly less, and dietary fiber intake was
significantly more, during the oat bran period compared to the diet
only period. The results of this study, therefore, are inconclusive for
an effect of oat bran on serum cholesterol.
Mackay and Ball (Ref. 28) evaluated the hypocholesterolemic
properties of 55 g each of low-fiber and high-fiber oat bran (New
Zealand cultivars) and of beans in hypercholesterolemic subjects
consuming a moderately low fat diet. The oat bran used in this study
was specially formulated to provide specific amounts of -
glucan. The low-fiber oat bran provided 1.9 g -glucan, and the
high-fiber oat bran provided about 3 g -glucan. The results of
this study showed no significant changes in serum cholesterol or LDL-
cholesterol from any of the test substances. HDL-cholesterol, however,
increased in all groups compared to baseline values, and these
increases were statistically significant (p<0.05). The energy intake on
the high-fiber oat bran diet was significantly higher than that of the
low-fat diet alone; however, there was no reported change in body
weights. This study lacked a placebo control which makes the study
difficult to interpret. Also, the source of this oat bran, a New
Zealand cultivar, may have contributed to the lack of a
hypocholesterolemic response to oat bran in this study (see Refs. 13
and 26).
Stewart et al. (Ref. 36) reported no significant differences in
serum cholesterol, LDL-, or HDL-cholesterol in subjects consuming an
oat-free, low fat diet or a low fat diet with 50 g/d of oat bran for 6
weeks each. However, the subjects' compliance with the required dietary
protocol in this study was poor. The authors reported a wide
variability among the subjects' diets at baseline as well as a
variability in the intake of oat bran. Moreover, both processed and
unprocessed New Zealand oat brans were used in this study. As stated in
the previous paragraph, the type of oat bran cultivar used, and the
method of processing the oat bran, may have affected the results of
this study.
Uusitupa et al. (Ref. 41) evaluated the hypocholesterolemic effects
of a -glucan-enriched oat bran and regular wheat bran in
hypercholesterolemic subjects consuming an AHA Step 1 diet. Baseline
serum cholesterol values were determined during a 4-week run-in period
when the subjects consumed the AHA Step 1 diet with no bran. The
subjects were then randomized into two groups to receive the -
glucan-enriched oat bran or regular wheat bran for an 8-week test
period. The brans were provided in sachets (62 g/sachet), and the
subjects instructed to increase their daily consumption of bran in a
step-wise approach until they consumed the entire contents of the
sachet or until they reached the highest tolerable amount. The mean
intake of oat bran during the test period was 50 g. At the end of 4
weeks of bran intervention, there was a significant reduction in serum
cholesterol in the oat bran group compared to baseline. By the end of 8
weeks, however, the differences were no longer significant. There was
no change in LDL-cholesterol in the oat bran group after 4 weeks, but a
small, nonsignificant reduction (about 3 percent) after 8 weeks. There
was a small, nonsignificant increase in serum cholesterol in the wheat
bran group. The results of this study were difficult to interpret
because subjects did not adhere to the reduced fat diet and failed to
consume the required amount of bran.
Two studies (Refs. 10 and 46) showed equivocal results in reducing
total cholesterol. Bartram et al. (Ref. 10) evaluated the effect of oat
bran muesli cereal on serum cholesterol in 13 men and women who had
been on a low cholesterol diet for 6 months. The subjects consumed 60 g
of oat muesli (made with lowfat milk and 120 g of bananas, grapes, and
apples) for 3 weeks. The results of this study showed a significant
reduction in serum cholesterol (8-10 percent) (p<0.01) and LDL-
cholesterol (p<0.05) during the oat cereal period. However, the results
are difficult to interpret because the fruits consumed with the muesli
cereal may have contributed to the observed reduction in serum
cholesterol.
Zhang et al. (Ref. 46) compared the hypocholesterolemic properties
of oat
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bran (118 g) with wheat flour using a crossover design. The subjects
consumed one of the test substances as part of a low fiber base diet
for 3 weeks before crossover to the other test substance. During the
oat period, serum cholesterol was significantly lower than during the
wheat flour period. The results of this study are difficult to
interpret because all subjects had ileostomies (i.e., an opening from
the ileum through the abdominal wall, permitting drainage of the
contents of the small intestine) and the mechanism by which oat bran
lowers serum lipids in this group may not apply to the general
population.
3. Normocholesterolemics: ``Typical'' or ``Usual'' Diets
The results of two studies (Refs. 17 and 29) support a cholesterol
lowering effect of oat bran or oatmeal in subjects with normal serum
cholesterol values. A third study (Ref. 14) showed evidence of the
cholesterol-lowering effects of oat bran postprandially.
Gold and Davidson (Ref. 17) reported a significant (p<0.05)
reduction in total cholesterol (5.3 percent) and LDL-cholesterol (8.7
percent) compared to baseline measures in normocholesterolemic subjects
consuming 2 oat bran muffins/d for 4 weeks. The oat bran muffins
provided a total of 34 g oat bran. There were no data given on the
subjects' dietary intake before or during the test period.
Marlett et al. (Ref. 29) studied the mechanism of serum cholesterol
reduction by oat bran using a single isotope to determine bile acid
kinetics. During the first month, normo- cholesterolemic subjects
consumed a low fiber control diet provided in a metabolic unit. During
the second month, this same diet was supplemented with 100 g of oat
bran. The results showed significantly lowered serum cholesterol
compared to baseline values during both periods. Serum cholesterol on
the low fiber diet was reduced 14 percent (p<0.01) and on the oat bran
diet 22 percent (p<0.01) compared to baseline values. Serum cholesterol
during the high fiber period was also significantly lower than that of
the low fiber period (an additional decrease of 9 percent).
Cara et al. (Ref. 14) evaluated the effects of oat bran and other
high fiber-containing foods on postprandial lipemia in 6
normocholesterolemic men. The subjects consumed, on separate days, a
low fiber (control) meal or a high fiber test meal enriched with 10 g
of oat bran, rice bran, wheat fiber, or wheat germ. The results of this
study showed that the oat bran test meal produced the greatest
reduction in serum cholesterol compared to the other fibers tested. The
differences between serum cholesterol levels in the oat bran test and
those in the control test remained significant (p<0.05) 7 hours
postprandial. The results of this study support a significant short
term effect on serum cholesterol, but they do not address long term
effectiveness of oat bran in maintaining reduced serum cholesterol
levels.
The results of one study (Ref. 31) was inconclusive for an effect
of oatmeal on serum cholesterol in normo-cholesterolemic subjects.
O'Kell and Duston (Ref. 31) reported no significant differences in
serum cholesterol and HDL-cholesterol in subjects consuming 1/2 to 3/4-
cup of oatmeal daily for a series of 3-month test periods over the
course of a year. After each 3-month oatmeal period, the subjects
consumed their usual diets without oatmeal for 3 months. The results of
this study were difficult to interpret because the subjects' dietary
intakes before and during the study were not reported, and subject
compliance was not adequately addressed.
One study (Ref. 37) showed equivocal results in reducing total
cholesterol. Swain et al. evaluated the hypocholesterolemic effects of
oat bran and wheat bran in a group of young females with normal serum
cholesterol (mean total cholesterol of 185 mg/dL) using a double-blind,
cross-over study design. The subjects consumed an average of 87 g oat
bran and 93 g wheat bran/day during each 6-week test period. The
authors reported statistically significant reductions from baseline
levels in total cholesterol (p<0.05) and LDL-cholesterol (p<0.05) in
both bran test periods. The differences between the oat bran and wheat
bran groups were not significant. The results of this study are
difficult to interpret because of dietary changes during the oat bran
period. The subjects significantly increased their intake of total
calories from fat and saturated fat compared to the wheat period. Mean
body weight was unchanged over the short test period suggesting that
there was a substitution effect with the diet. Young premenopausal
women with low serum cholesterol levels do not represent a population
at risk for CHD. Therefore, the benefits of oat bran may not be
reflected in this group.
4. Normocholesterolemics: Low Fat Diets
One study (Ref. 42) reported significantly lower total cholesterol,
compared to a control group, after 4-weeks of oat intervention in
subjects with normal to mildly elevated total cholesterol. The oat
group consumed a Phase II AHA diet (low fat, low saturated fat, low
cholesterol) plus 56 g of oatmeal daily compared to a control group
that consumed only the Phase II diet. Over the next 4 weeks, however,
serum cholesterol levels increased slightly in the oat group and
decreased slightly in the control group. After 8 weeks, serum
cholesterol was reduced 3.1 percent in the oat group and 1.4 percent in
the control group. There were no significant differences in total serum
cholesterol levels between the groups. Subgroup analysis of the data
showed greater reductions in serum cholesterol among those subjects in
the oat group who had the highest baseline cholesterol levels. The
results of this study suggest a modest benefit of oatmeal in lowering
serum cholesterol in subjects with normal cholesterol levels.
One survey (Ref. 19) showed equivocal results for an effect of oat
bran or oatmeal on serum cholesterol. He et al. (Ref. 19) evaluated the
relationship between the intakes of oats and buckwheat and serum
cholesterol in a population of Chinese by conducting a survey of their
dietary habits. This particular population group consumed a high
energy, low fat, and high fiber diet, and had active working
lifestyles. The results of this study showed that the groups consuming
greater than 25 g of oats a day had significantly lower serum
cholesterol than those who ate less than 25 g of oats a day or no oats.
All baseline serum cholesterol values, however, were under 160 mg/dL.
The results of this study were difficult to interpret because this
population group is one whose diets and lifestyles do not reflect that
of the general American population. The results of this study are also
confounded because of the questionable assessment of dietary intake of
oat bran and oatmeal and the absence of any controls.
5. Other Studies
Evidence for the cholesterol-lowering effect of soluble fiber from
oatmeal and oat bran was evaluated using a metaanalysis (Ref. 33). In
this study, after pooling the raw data from 13 studies (Refs. 11, 15
through 17, 23, 25, 30, 37, 39, 40, and 42 through 44) that reported on
the effect of consumption of oatmeal and oat bran on total cholesterol,
a modest reduction (average decrease of 5 to 6 mg/dL) on blood total
cholesterol levels was found.
To assess whether other dietary factors, i.e., substitution of oats
for dietary fats and cholesterol, might have been responsible for the
drop in blood
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total cholesterol levels, Ripsin and coworkers used the experimentally
derived, predictive equation of Keys to see whether dietary changes in
fat components of the test diets could account for the observed
decreases in serum cholesterol (Ref. 33). The results of their analysis
showed that reduction in fat and cholesterol intake attributable to
substituting oat bran or oatmeal for these food components did not
account for all of the blood cholesterol reduction observed. Oat bran
and oatmeal apparently had some effect beyond that of simply replacing
fat and cholesterol in the diet. The authors concluded, therefore, that
incorporation of oat products into diets causes a modest decrease in
average blood cholesterol.
The authors also suggested that there was a dose-response
relationship between the amount of soluble fiber from oat bran or
oatmeal and the reduction in blood cholesterol levels, with intakes of
soluble fiber from oats above 3 g/day showing more effect than lower
intakes. They stated that there is significant evidence of an
interaction between dose and initial cholesterol levels. The trials
that used subjects with initial serum cholesterol levels of 229 mg/dL
or higher demonstrated fivefold greater reductions in total cholesterol
with 3 g/d or more of soluble fiber from oat bran or oatmeal than
trials whose subjects had lower initial cholesterol levels.
Additionally, the authors noted that other components in oats may play
a role in the observed cholesterol reduction and suggested the need for
long-term clinical trials (6 months or more) with multiple doses to
verify their conclusions from the metaanalysis.
LSRO, in its 1987 report entitled ``Physiological Effects and
Health Consequences of Dietary Fiber,'' stated that oat bran has been
shown to exert a substantial cholesterol-lowering effect in patients
with hypercholesterolemia (Ref. 7). It noted that the effects of oat
bran are not as pronounced in subjects with normal serum cholesterol as
they are in subjects with elevated serum lipid levels.
6. Summary
Of the 37 studies that FDA reviewed, 4 studies (Refs. 9, 14, 22,
and 30) had short test periods, ranging from 7 hours to 18 days and,
thus, did not meet the agency's criteria for selecting pertinent
studies with respect to study duration (i.e., intervention test period
of no less than 3 weeks).
Seventeen studies (Refs. 8, 11, 12, 15, 17, 20, 21, 23, 24, 25, 29,
35, 39, 42 through 45) demonstrated a positive effect of oat bran or
oatmeal on total and LDL-cholesterol. The majority of these studies
showed statistically significant reductions in total and LDL-
cholesterol in hypercholesterolemic subjects consuming either a typical
American diet (Refs. 8, 12, 20, 21, 25, 35, 44, and 45) or a low fat
diet (Refs. 11, 15, 23, 24, 39, 42, and 43). The results of three
studies showed a statistically significant effect of oat bran or
oatmeal in subjects with normal serum cholesterol consuming either a
typical American diet (Refs. 17 and 29) or a low fat diet (Ref. 42).
The amount of oat bran or oatmeal consumed daily to lower total and
LDL-cholesterol in the above studies ranged from 34 g (2.5 g soluble
fiber) (Ref. 17) to 123 g (10.3 g soluble fiber) (Ref. 45). In those
studies that evaluated HDL-cholesterol responses to oat intervention,
three reported a slight, nonsignificant decrease in HDL-cholesterol
(Refs. 8, 11, and 21); four reported no change (Refs. 12, 20, 23, and
35); and five reported a slight increase in HDL- cholesterol as a
result of oat intervention (Refs. 24, 25, 39, 42, and 45).
Five studies (Refs. 10, 19, 32, 37, and 46) showed equivocal
results in reducing serum cholesterol. The results by Bartram et al.
(Ref. 10) were difficult to interpret because fruits were included in
the oat bran cereal. The soluble fiber of the fruit may have had an
independent effect on serum lipid levels. The questionable assessment
of dietary intake and the lack of temporal sequence in an uncontrolled,
cross-sectional survey conducted by He et al. (Ref. 19) make the
beneficial results of this study difficult to interpret. In addition,
the population group used in this study (i.e., Chinese farmers and
migrants) do not reflect the general population in the United States.
The agency also questioned the appropriateness of the population groups
used in two other studies (Refs. 37 and 46). Zhang et al. (Ref. 46)
showed significant reductions in total cholesterol in subjects who had
ileostomies. The mechanism by which oat bran or oatmeal help lower
serum lipids in this population may not reflect the general population
in the United States. Swain and coworkers (Ref. 37) evaluated the
cholesterol-lowering properties of oat bran and wheat in a group of
young pre-menopausal women with low serum cholesterol levels, a group
who does not represent a population at risk for CHD. Dietary changes
were reported during the oat period which also make interpretation of
the results difficult.
Significant dietary changes during the oat intervention period made
it difficult to interpret the results of another study (Ref. 32).
Poulter et al. (Ref. 32) reported significant reductions in total and
LDL-cholesterol in subjects consuming 56 g of oat cereal. There were no
significant changes in total and LDL-cholesterol when the subjects
consumed their usual (control) cereal. However, an analysis of the
nutrient data revealed a significant reduction in total energy from fat
and in the ratio of polyunsaturated to saturated fat (P:S) during the
oat period.
In the 11 studies in which no effect on serum lipid levels were
found (Refs. 13, 16, 18, 26 through 28, 31, 34, 36, 38, and 41), a
number of reasons were advanced for the lack of a positive finding. A
lack of compliance and changes in dietary intakes by the subjects
plagued a number of these studies (Refs. 18, 27, 31, 34, and 41). The
source of the oat cultivars allegedly contributed to the lack of an
effect of oat bran or oatmeal on serum lipids in four others (Refs. 13,
26, 28, and 36). The authors of these studies noted that New Zealand
oat cultivars tend to have lower levels of soluble fiber than oat
cultivars used in studies showing cholesterol-lowering properties.
The processing of oats allegedly caused a loss of effectiveness in
another study (Ref. 38). Torronen and coworkers found that wet milling
Finnish oats to produce an oat bran concentrate negatively affected the
hypocholesterolemic properties of oat -glucan.
The results of the study by Demark-Wahnefried et al. (Ref. 16)
suffered from a lack of statistical power to detect changes between
groups, variable weight loss among the groups, and significant dietary
changes during the course of the study.
IV. Decision To Propose a Health Claim Relating Oat Products to
Reduction in Risk of CHD
The petition set out the conclusions reached by the Federal
government and other recognized scientific bodies, as well as those
reached in review articles and in pertinent human studies published
since 1987. FDA reviewed this information as well as those studies that
evaluated the effects on serum cholesterol and LDL-cholesterol levels
from dietary intervention with oat bran or oatmeal in subjects with
normal to elevated serum cholesterol levels.
FDA tentatively concludes that, based on the totality of publicly
available scientific evidence, there is significant scientific
agreement to support the relationship between consumption of oat bran
or oatmeal as foods, or as ingredients in foods, and the risk of CHD.
The strongest evidence for the effect of oat bran or oatmeal on the
risk of CHD is provided by studies that
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measured the effect of dietary oat consumption on the two major risk
factors for CHD, total and LDL-cholesterol. FDA is aware of five
studies of that effect in which problems associated with subject
compliance and weight loss were avoided and in which appropriate
controls were used (Refs. 12, 25, 29, 39, and 45). All of these studies
showed a significant relationship between oat consumption and lowered
serum total and LDL-cholesterol levels and no adverse effect on other
CHD risk factors, such as significantly lowering HDL-cholesterol. The
daily oat intake ranged from an estimated 70 g oat bran (Ref. 12) to
150 g oat bran (Ref. 39). Four of these studies (Refs. 12, 25, 39, and
45) were conducted in subjects with mild to moderately elevated levels
of serum cholesterol. One study (Ref. 29) used subjects with normal
serum cholesterol levels.
Braaten et al. (Ref. 12) showed that when subjects consumed an
amount of purified oat gum (containing 80 percent -glucan)
equivalent to consuming 70 g oat bran daily, total and LDL-cholesterol
were significantly reduced, and HDL-cholesterol remained unchanged. The
oat gum was consumed with a typical American diet.
Kestin et al. (Ref. 25) showed significant reductions in total and
LDL-cholesterol, compared to blood lipid levels during wheat and rice
bran periods, in subjects who consumed 95 g oat bran/day for 4 weeks
(Ref. 25). HDL-cholesterol showed slight, nonsignificant increases
compared to baseline in all diet periods. The subjects consumed the
test foods as part of their usual diet.
Subjects with moderate hypercholesterolemia showed significant
reductions in total and LDL-cholesterol after they consumed 150 g oats/
day for 4 weeks compared to baseline lipid levels (Ref. 39). These same
subjects experienced small increases in total and LDL-cholesterol (not
significant) after consuming wheat products. Blood levels of HDL-
cholesterol increased slightly (not significant) during the oat period
but remained the same during the wheat period. All subjects consumed a
low fat diet in this study.
Whyte et al. (Ref. 45) reported significant reductions in total and
LDL-cholesterol in subjects who consumed 123 g oat bran/day for 4 weeks
as part of their usual diets. The subjects experienced a slight
increase in total cholesterol and no change in LDL-cholesterol after
consuming wheat bran. HDL-cholesterol increased slightly (not
significant) during both bran periods.
In a study designed to assess the mechanism by which oat bran
lowers total cholesterol, Marlett et al. (Ref. 29) reported significant
reductions in total cholesterol in the period in which subjects
consumed oat bran compared to a wheat control period. The subjects
consumed 100 g oat bran/day for 4 weeks during the high fiber period
and wheat gluten during the low fiber, control period, with their usual
diets.
The results of 12 other studies (Refs. 8, 11, 15, 17, 20, 21, 23,
24, 35, and 42 through 44) also support the relationship between oat
consumption and reduction in total and LDL-cholesterol. Six studies
(Refs. 8, 17, 20, 21, 35, and 44) showed the benefits of oat
intervention in reducing serum total and LDL-cholesterol in subjects
consuming a typical American diet. HDL-cholesterol showed no
significant change in four of these studies (Refs. 8, 20, 21, and 35)
and a significant reduction in one study (Ref. 21). The amount of oat
bran or oatmeal consumed in these studies ranged from 34 g/day (Ref.
17) to 110 g/d (Ref. 8).
Three studies (Refs. 15, 23, and 24) showed a significant effect of
oat bran or oatmeal on total and LDL-cholesterol that was beyond that
of a Step 1 diet alone. The results of the three other studies (Refs.
11, 42, and 43) showed lower, nonsignificant, total and LDL-cholesterol
in subjects who consumed oat bran or oatmeal compared to the group who
consumed the Step 1 or Step 2 diets alone. In two of these studies
(Refs. 42 and 43), the subjects' lipid values after a run-in period on
the low fat diet ranged from a mean of 193 to 197 mg/dL. The lack of
significant difference between the diet only and the oat groups in
these studies may be overshadowed by the effect of the diet alone on
subjects who had initially low total and LDL-cholesterol levels. There
were no significant changes in HDL- cholesterol from the consumption of
a low fat diet plus oats. The range of oat intake in these studies
ranged from 35 g (Ref. 43) to 100 g/day (Ref. 24).
Two studies (Ref. 20 and 23) used wheat as a placebo control. The
results of these studies showed significantly lower total and LDL-
cholesterol in subjects who consumed oat bran compared to those who
consumed wheat.
A metaanalysis (Ref. 33) using pooled, raw data from a number of
oat studies (Refs. 11, 15 through 17, 23, 25, 30, 37, 39, 40, and 42
through 44) found that an intake of 3 g soluble fiber (used as a marker
for oat bran and oatmeal) or more produced modest reductions (average
decrease of 5 to 6 mg/dL) of serum total cholesterol levels. The
decrease in total cholesterol was largest in those trials with subjects
that initially had high total cholesterol levels.
As stated in section III.A. of this document, Federal government
and other reviews have concluded that there is substantial
epidemiologic and clinical evidence that high blood levels of total
cholesterol and LDL-cholesterol represent major contributors to CHD (56
FR 60727 at 60728, and Refs. 3 through 5). Dietary factors that
decrease total cholesterol and LDL-cholesterol will affect the risk of
CHD (Refs. 3 through 6). Based on the scientific evidence presented in
the petition, the agency tentatively concludes that there is
significant scientific evidence to show that oat bran and oatmeal will
help reduce serum lipids, and that such reductions may reduce the risk
of CHD. In the majority of clinical studies evaluating oat products,
total and LDL-cholesterol fractions were shown to be the most affected
by oat intervention. Regular consumption of oat bran or oatmeal, in an
amount to provide 3 g or more of oat -glucan soluble fiber,
resulted in reduced total and LDL-cholesterol levels in subjects with
normal and elevated serum cholesterol levels.
Changes in HDL-cholesterol levels as a result of oat intervention
were generally absent or not significant (Refs. 8, 11 through 13, 18,
20, 23 through 28, 32, 35 through 39, 41, 42, and 45). A tendency
toward an increase in HDL-cholesterol was shown in nine studies (Refs.
13, 24, 25, 27, 28, 32, 39, 42, and 45); no change was shown in nine
studies (Refs. 8, 12, 18, 20, 23, 24, 35, 36, and 41); and a
nonsignificant decrease in HDL-cholesterol was shown in three studies
(Ref. 11, 26, and 38). Although HDL-cholesterol was reduced 0.9 percent
(p<0.03) in the study by Kahn et al. (Ref. 21), the HDL:LDL and
HDL:total cholesterol ratios were improved, compared to baseline,
because of significant reductions in total cholesterol (8 percent) and
LDL-cholesterol (10 percent).
Oat bran and oatmeal were tested in a variety of food forms but
produced fairly consistent results, showing that the way in which these
foods are consumed does not alter their effect on serum lipids. They
were consumed as hot and cold cereals or used in a variety of other
foods, such as muffins, breads, shakes, and entrees.
The eleven studies that did not show reduced total and LDL-
cholesterol from the consumption of oat bran or oatmeal (Refs. 13, 16,
18, 26 through 28, 31, 34, 36, 38, and 41) do not detract from the
agency's tentative conclusion about this relationship or that the claim
is valid.
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The lack of result in five of these studies (Refs. 13, 26, 28, 36, and
38) was apparently attributed to the oat source, i.e., New Zealand
cultivars, or to the method of processing oat bran. The results of the
remaining six studies were associated with a lack of subject compliance
and significant changes in dietary intake during the test periods, or
to problems in study design, i.e., a lack of statistical power to
detect changes between groups.
Given all of this evidence, the agency is proposing a health claim
on the relationship between oat bran and oatmeal and reduced risk of
CHD.
V. Description and Rationale for Components of Health Claim
A. Relationship Between Oatmeal and Oat Bran and CHD and the
Significance of the Relationship
Proposed Sec. 101.81(a) describes the relationship between diets
high in oat bran or oatmeal and the risk of CHD. In proposed
Sec. 101.81(a)(1), the agency recounts that CHD is the most common and
serious form of CVD, and that CHD refers to diseases of the heart
muscle and supporting blood vessels. The regulation also notes that
high blood total and LDL-cholesterol levels are associated with
increased risk of developing CHD. The regulation identifies the levels
of total cholesterol and LDL-cholesterol that would put an individual
at high risk of developing CHD and those serum lipid levels that are
associated with borderline high risk. The intent is to provide
consumers with information to help them understand the seriousness of
CHD.
In proposed Sec. 101.81(a)(2), the agency recounts that populations
with a low incidence of CHD tend to have low blood total and LDL-
cholesterol levels. It states that these populations also tend to have
dietary patterns that are low in total fat, saturated fat, and
cholesterol and high in fruits, vegetables, and grain products, such as
oatmeal and oat bran. This information is consistent with that provided
in the authorized health claim for fruits, vegetables, and grain
products and CHD (Sec. 101.77). The agency tentatively finds that this
information provides a basis for a better understanding of the numerous
factors that contribute to the risk of CHD and the relationship between
oat bran and oatmeal and a low fat diet.
Proposed Sec. 101.81(a)(3) describes the relationship between oat
bran and oatmeal, foods low in saturated fat and cholesterol, and
reduction in the CHD risk factors. The paragraph states that several
studies have shown that diets high in oatmeal or oat bran are
associated with reduced blood lipid levels. This information
encapsulates the scientific evidence about how oatmeal and oat bran can
contribute to reduction in heart disease risk factors.
Proposed Sec. 101.81(b) describes the significance of the diet-
disease relationship. In proposed Sec. 101.81(b)(1), the agency
recounts that CHD remains a major public health concern in the United
States because the disease accounts for more deaths than any other
disease or group of diseases. The claim states that early management of
modifiable risk factors for CHD is a major public health goal that can
assist in reducing the risk of CHD. This information is consistent with
the evidence that lowering blood total and LDL-cholesterol levels
reduces the risk of CHD (56 FR 60727, 58 FR 2739, and Refs. 3 through 6
and 47).
In proposed Sec. 101.81(b)(2), the significance of the relationship
between oatmeal and oat bran and CHD risk factors in context of the
total diet is discussed. The agency recounts that many Americans'
intakes of saturated fat and cholesterol exceed recommended levels, and
it summarizes public health recommendations for the diet (56 FR 60727
at 60738 and Sec. 101.75(b)(3)). This paragraph also states that
scientific evidence demonstrates that diets high in oatmeal and oat
bran and low in saturated fat and cholesterol are associated with
reduced blood lipids. FDA tentatively concludes that the latter
statement is scientifically valid based on the evidence that it has
reviewed on this nutrient-disease relationship.
B. Nature of the Claim
In Sec. 101.81(c)(1) (21 CFR 101.81(c)(1)), FDA is proposing to
require that all of the general requirements for health claims set out
in Sec. 101.14 be met. This provision is consistent with the provisions
of the other specific health claim regulations in part 101, subpart E,
of the Code of Federal Regulations (CFR) (21 CFR part 101, subpart E).
In Sec. 101.81(c)(2)(i), FDA is proposing to authorize a health
claim on the relationship between diets high in oat bran or oatmeal and
the risk of CHD. The agency is proposing to do so based on its review
of the scientific evidence on this nutrient-disease relationship which
shows that diets that are high in oat bran or oatmeal help to reduce
total and LDL-cholesterol levels in individuals with normal to elevated
blood total cholesterol (Refs. 8, 11, 12, 15, 17, 20, 21, 23 through
25, 29, 35, 39, 44, and 45). This result is significant for the risk of
heart disease because elevated levels of total and LDL-cholesterol are
associated with increased risk of CHD (Refs. 3 through 6).
In Sec. 101.81(c)(2)(i)(A), the agency is proposing to require,
consistent with other health claims, that the relationship be qualified
with the terms ``may'' or ``might.'' These terms are used to make clear
that not all persons can necessarily expect to benefit from these
dietary changes (56 FR 60727 at 60740 and 58 FR 2552 at 2573).
In Sec. 101.81(c)(2)(i)(B), the agency is proposing to require,
consistent with other authorized health claims, that the terms
``coronary heart disease'' or ``heart disease'' be used in specifying
the disease. These terms are commonly used in dietary guidance
materials, and therefore they should be readily understandable to the
consumer (56 FR 60727 at 60740 and 58 FR 2552 at 2573).
In Sec. 101.81(c)(2)(i)(C)(1), the agency is proposing that the
claim describe the relationship between diets high in oatmeal or oat
bran and risk for CHD. Based on its review of the scientific evidence
submitted with the petition, the agency tentatively concludes that
there is significant scientific agreement that diets high in oat bran
or oatmeal may help to r
FR Doc. 96-29 Food Labeling: Health Claims; Oats and Coronary Heart Disease
educe blood total and LDL-cholesterol levels,
the major modifiable risk factors for CHD (Refs. 12, 17, 20, 21, 25,
29, 35, 44, and 45).
The petitioner stated in its petition that there is significant
scientific evidence to show that the effect of oats on lowering serum
lipids is independent of a diet low in saturated fat and cholesterol.
In light of this evidence, the petitioner argued that any health claim
that is authorized need not refer to such a diet. The petitioner
explained that important public health policy objectives, as well as
FDA's statutory mandate to authorize health claims supported by
significant scientific agreement, mandate that FDA issue a regulation
that requires only that claims describe the relationship between oat
products and reduced risk of CHD (Ref. 1, p. 68).
The agency acknowledges that there were a number of studies that
showed that high intakes of oat bran and oatmeal lowered blood total
and LDL-cholesterol in subjects that otherwise consumed a typical
American diet (Refs. 12, 17, 20, 21, 25, 29, 35, 44, and 45). However,
as stated in section V.A. of this document, CHD is a major public
health concern in the United States, and that the totality of the
scientific evidence provides strong and consistent support that diets
high in saturated fat and cholesterol are associated with elevated
levels of blood total and LDL-cholesterol, and thus CHD (56 FR 60727
[[Page 306]]
at 60737). Dietary estimates for American adults show that the average
saturated fat intakes of American adults are about 13 percent of
calories, total fat intakes are about 37 percent of calories, and
average cholesterol intakes range from 300 to over 400 mg daily for
adult men and women (56 FR 60727 at 60738). The current intakes of
saturated fat and total fat are thus well in excess of recommended
goals of less than 10 percent and 30 percent of calories. Dietary
guidelines from both government and private-recognized scientific
bodies conclude that the majority of the American population would
benefit from decreased consumption of dietary saturated fat and
cholesterol (Refs. 3 through 6).
The results of several studies showed that while daily consumption
of oat bran or oatmeal lowered total cholesterol and LDL-cholesterol,
the effects of dietary intake of oat bran or oatmeal were particularly
evident when the diets were low in saturated fat and cholesterol (Refs.
11, 15, 24, 39, and 43). Thus, the agency tentatively finds that it
will be more helpful to Americans' efforts to maintain healthy dietary
practices if the effect of oats on serum lipids is described in context
of a healthy diet. This information is extremely important to a full
understanding of the significance of the claim.
The agency tentatively finds that for the public to understand
fully, in the context of the total daily diet, the significance of
consumption of oat bran and oatmeal on the risk of CHD (see section
403(r)(3)(B)(iii) of the act), information about the total diet needs
to be included as part of the claim. Therefore, in
Sec. 101.81(c)(2)(i)(C)(2), the agency is proposing to require that the
claim include the fact that the effect of dietary consumption of
oatmeal or oat bran on the risk of CHD is particularly evident when
these foods are consumed as part of a diet that is low in saturated fat
and cholesterol. Based on its review of the scientific evidence
submitted with the petition, the agency tentatively concludes that
there is significant scientific agreement that diets high in oat bran
or oatmeal and low in saturated fat and cholesterol are associated with
reduced blood total and LDL-cholesterol levels (Refs. 11, 15, 23, 24,
39, 42, and 43).
FDA is proposing to require that this dietary information be
included as part of the full health claim to ensure that people
understand the significance of the information in the claim. A diet low
in saturated fat and cholesterol is important because if intake of
these dietary components are not controlled, then there is a
significant question as to whether high fiber diets will have their
full effect on blood total and LDL-cholesterol levels, and thus on the
risk of heart disease. However, based on information supplied by the
petitioner, FDA tentatively concludes that a claim that diets high in
oat bran or oatmeal may reduce the risk of heart disease is truthful,
not misleading, and scientifically valid without this additional
information. Therefore, FDA tentatively finds that it is appropriate to
require that a label that bears an oat bran or oatmeal health claim
disclose the fact that a diet should be high in oat bran and oatmeal
and low in saturated fat and cholesterol, but that it is not necessary
to require that the latter dietary information be disclosed in
immediate proximity of the oat bran or oatmeal claim each time the
claim appears on the label or in labeling (see the discussion of
Sec. 101.81(c)(2)(ii) below). FDA is proposing to require only that the
full statement of the claim disclose the fact that the effect of the
dietary intake of oat bran or oatmeal is particularly evident when the
diet is low in saturated fat and cholesterol.
Proposed Sec. 101.81(c)(2)(i)(D), consistent with other authorized
health claims, requires that the claim not attribute any degree of risk
reduction of CHD to consumption of oat products. None of the studies
that the agency reviewed provide a basis for determining the percent
reduction in risk of CHD likely from consuming diets high in oat
products.
The agency considered proposing to require that the claim state
that the development of CHD depends on many factors. This statement has
been required in the two authorized heart disease health claims
(Secs. 101.75 and 101.77) (although the agency has recently proposed to
delete this requirement in a document that published in the Federal
Register of December 21, 1995 (60 FR 66206) (hereinafter referred to as
the 1995 proposal). The petitioner requested that the statement
regarding the multifactorial nature of CHD be listed under optional
requirements for the health claim (Ref. 1, p. 68). The petitioner
stated that based on an ever increasing background of health
information made available through various media, consumers already
understand that foods are not drugs, and that health enhancement
depends not only on consumption of a particular food but also on other
dietary practices, exercise, heredity, lifestyle, and a host of other
factors. The petitioner did not provide any data to support this
observation. The petition stated that the ``depends on many factors''
language makes the health claim cumbersome, unnecessarily long, and
detracts from its central and critical consumer message. The petition
stated that using the required statement ``may help'' (i.e., ``may help
reduce the risk of heart disease'') more simply, directly, and
succinctly indicates to consumers that oatmeal and oat bran are not
magic bullets, and that other factors are associated with CHD risk.
The agency agrees with the petitioner that the requirement that the
claim use the term ``may'' or ``might'' to relate the ability of oat
bran or oatmeal to reduce the risk of heart disease is intended to
reflect the multifactorial nature of the disease. In response to
comments on the scientific standard proposed for health claims, the
agency stated in the 1993 health claims final rule (58 FR 2478 at
2505):
* * * Further, absolute claims about diseases affected by diet are
generally not possible because such diseases are almost always
multifactorial. Diet is only one factor that influences whether a
person will get such a disease. For example, in the case of calcium
and osteoporosis, genetic predisposition (e.g., where there is a
family history of fragile bones with aging) can play a major role in
whether an individual will develop the disease. Because of factors
other than diet, some individuals may develop the disease regardless
of how they change their dietary patterns to avoid the disease. For
those individuals, a claim that changes in dietary patterns will
reduce the risk of disease would be false. Thus, health claims must
be free to use the term ``may'' with respect to the potential to
reduce the risk of disease. * * *
The agency notes that FDA has been asked in a petition from the
National Food Processors Association (NFPA) (Docket No. 94P-0390) to
reevaluate the required elements of the health claim and to consider a
number of options including the option of using an abbreviated health
claim and eliminating the multifactorial element of the health claim
requirements. In the 1995 proposal, the agency initiated rulemaking
that, in part, proposed to eliminate or make optional some of the
required elements. More specifically, the agency proposed to make
optional the statement ``a disease caused by many factors'' (see
section IV.E. of the 1995 proposal), and to permit the use of certain
abbreviated health claims on the label or labeling of a product (see
section IV.C. of the 1995 proposal) (60 FR 66206). In this proposed
rule on oat bran and oatmeal and CHD, the agency is proposing to make
the phrase ``depends on many factors'' optional information. In place
of the requirement for stating the multifactorial nature of
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the disease, the agency is proposing Sec. 101.81(c)(2)(i)(E) to require
that the claim not imply that the consumption of oat bran and oatmeal
is the only recognized means of achieving a reduced risk of CHD. Thus,
the agency tentatively concludes that the concept of the multifactorial
nature of CHD will be preserved without adding additional words to the
claim. The agency requests comment on whether consumers will be misled
to believe that reduction of risk will be achieved if the
multifactorial nature of CHD is not stated on the claim. This proposed
rule would also permit use of a shortened version of the claim in
conjunction with the full claim (see section IV.C. of the 1995
proposal).
C. Presentation of the Claim
In proposed Sec. 101.81(c)(2)(ii), the agency is providing for how
the health claim is to be presented on the label or labeling. This
paragraph states that all of the elements listed in
Sec. 101.81(c)(2)(i) must be included in one presentation of the claim
on the label or labeling. As discussed in sections V.A. and B. of this
document, the scientific evidence provides strong and consistent
support that diets high in saturated fat and cholesterol are associated
with elevated levels of blood total and LDL-cholesterol, the major
modifiable risk factors for CHD. Because the typical American diet
tends to be high in saturated fat and cholesterol, dietary guidelines
recommend that Americans modify their intakes of food that contain
significant levels of saturated fat and cholesterol. From a public
health standpoint, it is important for the public to comprehend the
significance of the relationship between diets high in oat bran or
oatmeal and CHD risk in context of a diet low in saturated fat and
cholesterol. This relationship is supported by significant scientific
evidence as discussed above.
However, the 1995 proposal permits a short, simple statement of
certain health claims that is truthful, not misleading, and
scientifically valid, which may be used on the principal display panel,
as long as the full claim appears on the particular label or in the
particular labeling in which the short statement appears, and there is
a referral statement from the shortened to the full claim (60 FR
66206). In recognition of this fact, FDA is providing in proposed
Sec. 101.81(c)(2)(ii) that if a full statement of the claim appears on
a label or in a piece of labeling, other presentations of the claim may
appear on the label or in labeling that do not include the information
required in proposed Sec. 101.81(c)(2)(i)(C)(2) so long as there is a
referral statement to the full statement of the claim in immediate
proximity with the shortened statement. FDA has explained above the
basis for its tentative conclusion that the shortened claim need not
include the information in paragraph (c)(2)(i)(C)(2) regarding the
importance of low saturated fat and cholesterol diet.
The referral statement that FDA is proposing accompany the
shortened claim is consistent with that provided for in the general
requirements for nutrient content claims (Sec. 101.13) and health
claims (Sec. 101.14(d)(2)(iv)). This referral statement is short and
thus consistent with the use of an abbreviated claim. It is important,
however, because the agency tentatively finds that it is essential that
the consumer be directed to the full claim. Specifically drawing the
consumer's attention to the full claim will help to ensure that he or
she is able to comprehend the information that is being presented in
the context of the total daily diet.
In its 1993 health claims final rule, the agency stated that it did
not believe that it is appropriate to use abbreviated health claims as
referral statements (58 FR 2478 at 2512). The agency was concerned that
an abbreviated claim would not include facts that are material in light
of the representation that is made and that are necessary to understand
the claim in the context of the daily diet. The agency was concerned
that confusion is possible whenever the full health claim information
appears in a location different from that of the reference statement
and is especially likely to occur when a multiplicity of labeling is
associated with a product.
The agency has tentatively concluded that this proposed rule
addresses these concerns. It is providing for an abbreviated statement
that reflects the facts that are material under section 201(n) of the
act (21 U.S.C. 321(n)) and that are necessary to ensure that the claim
is scientifically valid. It is also providing for an accompanying
referral statement to additional information that is necessary for a
full understanding of the claim. The agency is concerned, however,
about the possibility that consumers may not read the complete claim,
and thus that they will not have all of the facts necessary to fully
understand the significance of the claim being made and to comprehend
the claim in the context of the daily diet. For this reason, the agency
is asking for data to demonstrate that permitting a shortened claim in
this manner will not significantly decrease the likelihood that
consumers will read the full claim so long as it appears prominently on
the label or in the piece of labeling.
In new Sec. 101.81 (c)(2)(ii)(A) and (c)(2)(ii)(B), the agency is
proposing, consistent with requirements for nutrient content claims in
Sec. 101.13 (g)(1) and (g)(2), requirements for the typesize and
location of the referral statement.
FDA has long held that accompanying information should be in a size
reasonably related to that of the information that it modifies. Section
403(f) of the act requires that information required under the act be
placed on the label with such conspicuousness as to render it likely to
be read. Section 403(r)(2)(B) of the act requires that a referral
statement for nutrient content claims appear prominently, although it
does not specify specific requirements such as to typesize or style.
For nutrient content claims, FDA established type size requirements for
referral and disclosure statements related to the area of the surface
bearing the principal display panel rather than to the type size used
for the nutrient content claim. The proportionality between the size of
the referral statement and the size of the label ensures that the
referral statement is presented with appropriate prominence. However,
when the claim is less than twice what the minimum size of the referral
statement would be given the size of the label and Sec. 101.105(i) (21
CFR 101.105(i)) the type size of the referral statement may be less
than that required under Sec. 101.105 for net quantity of contents. In
such circumstances, the referral statement is of appropriate prominence
if it is at least one-half the size of the claim and not less than one-
sixteenth of an inch. This approach to the type size requirement for
the referral statement provides flexibility to firms in utilizing label
space but still ensures adequate prominence for this statement. Because
health claim referral statements are used similarly to those that
accompany nutrient content claims and are likely to appear on the
principal display panel, the agency tentatively concludes that a health
claim referral statement should have the same type size requirements as
those for nutrient content claims. Therefore, the agency tentatively
concludes that the requirements for the referral statement set forth in
Sec. 101.105 (c)(2)(ii)(A) and (c)(2)(ii)(B) are appropriate when a
shortened health claim is used and is including them in this proposed
rule.
D. Nature of the Food
Proposed Sec. 101.81(c)(2)(iii)(A) requires that the food bearing
the health claim contain 13 g of oat bran or 20 g
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oatmeal, and that the oat bran or oatmeal contain, without
fortification, at least 1.0 g of -glucan soluble fiber. The
paragraph states that oat -glucan be determined by the
Association of Official Analytical Chemists (AOAC) official method
(i.e., method 992.28), per reference amount customarily consumed
(RACC).
The requirement that the food contain oat bran or oatmeal is
consistent with the scientific evidence that shows that oat bran or
oatmeal, when consumed as a food or as an ingredient in food, helps to
lower total and LDL-cholesterol.
The agency is not proposing to permit a claim for oat gums or oat
fibers, substances that may be manufactured by different methods and
are not well defined chemically or physically. These substances, like
all food fibers, are a complex matrix and factors, such as the
fermentability; particle size; molecular weight; chemical structure;
water holding capacity; nonfiber components; net charge; viscosity; and
cation-exchange capacity, binding, and chelation, may affect their
physiological properties (Ref. 7).
The effects of processing on the physiological properties of oat
bran were evidenced in three studies. In a study by Torronen et al.
(Ref. 38), a specially processed oat bran concentrate incorporated into
bread to provide 11.2 g/d -glucan showed no effect on lowering
serum lipids in a controlled study with hypercholesterolemic subjects.
Two other studies testing a specially processed oat fiber source
providing 3.3 g/d -glucan soluble fiber (Ref. 35) and oat gum
providing 5.8 g/d -glucan soluble fiber (Ref. 12) showed
significant reductions in blood total and LDL-cholesterol levels. The
latter two studies showing a cholesterol-lowering response did not
adequately characterize the material being tested to permit their (oat
fiber source and oat gum) inclusion in the regulations, however. If
manufacturers can document, through appropriate studies, that dietary
consumption of a well-characterized oat product, e.g., purified
extracts of oat gum or modified oat fiber isolates, has the effect of
lowering total and LDL-cholesterol levels, and has no adverse effects
on other heart disease risk factors (e.g., HDL-cholesterol), they
should submit that information in comments or petition FDA to amend
Sec. 101.81 to cover the substance.
Because the subject of this health claim petition is the effect of
oatmeal or oat bran on the risk of CHD, it is appropriate to consider
the levels of oat bran and of oatmeal intake that have been shown to
have significant effects on the levels of serum total and LDL-
cholesterol in establishing qualifying levels for foods to bear an
oatmeal or oat bran and CHD health claim. In the clinical studies that
showed that consumption of oatmeal or oat bran lowered total and LDL-
cholesterol, daily consumption ranged from 35 g (Ref. 43) to 84 g (Ref.
15) of oat bran and 34 g (Ref. 17) to 150 g (Ref. 39) of oatmeal. Based
on values provided in the petition, 35 g of oatmeal would provide about
1.75 g of -glucan soluble fiber, and 34 g of oat bran would
provide about 2.5 g of -glucan soluble fiber (Ref. 1, p. 66).
The higher the daily intake of oatmeal and oat bran, the higher the
intake of -glucan soluble fiber and the better the response in
lowering serum lipids. This observation is supported by the
metaanalysis of oat products by Ripsin et al. (Ref. 33) and is
consistent with the agency's comments on the Davidson et al. study
(Ref. 15) in the preamble to the 1993 dietary fiber and CVD final rule
(58 FR 2552 at 2568):
* * * [B]ased on the results of this study, an intake of soluble
fiber (in this case, -glucan from oats) of about 3 g per
day or more was beneficial in that it resulted in a significant
lowering of serum cholesterol in persons consuming a low-fat diet.
An intake of 3 g of -glucan soluble fiber is equivalent to
approximately 60 g of oatmeal or 40 g of oat bran (dry weight) (Ref. 1,
p. 67), the approximate midpoints of the consumption ranges of oat bran
and oatmeal that had an effect on blood lipids. The petitioner
suggested that 40 g of oat bran, 60 g of oatmeal, and 3 g -
glucan soluble fiber be considered as the standard for determining the
qualifying levels of oat bran and oatmeal for this health claim.
Applying a regression analysis to the results of Davidson et al. (Ref.
15), and using -glucan soluble fiber as a marker for oat bran
and oatmeal, the petitioner determined that 3 g -glucan would
be required to achieve a 5 percent reduction in serum cholesterol (Ref.
1, p. 22-27). The petition stated that a 5 percent reduction in serum
cholesterol is a desirable goal because that is the level that was
achieved as a result of a dietary fat and cholesterol focused
intervention in the Multiple Risk Factor Intervention Trial (MRFIT) and
Lipid Research Council (LRC) clinical trials (Refs. 1 and 40).
The petitioner stated that while current research may not
demonstrate that -glucan is the only component of oats that
affects blood lipids, it does suggest that it is an excellent marker
for cholesterol reduction potential (Ref. 1, p. 64). The petitioner
stated that the amount of -glucan also serves as a marker for
the content of oat bran and oatmeal in foods. Using 40 g of oat bran,
60 g of oatmeal, and 3 g -glucan as the qualifying amounts for
a CHD claim, the petitioner suggested that a single serving of an oat-
containing product (i.e., 1 RACC) should provide \1/3\ of this amount
(based on 3 servings a day). Thus, an oat bran-containing product would
have to contain at least 13 g oat bran (\1/3\ x 40 g) that provides 1
g -glucan (\1/3\ x 3 g) soluble fiber per RACC. An oatmeal-
containing product would have to contain no less than 20 g oatmeal (\1/
3\ x 60) that provides 1 g -glucan soluble fiber. The
petitioner stated that this approach is reasonable because it would
permit a wide variety of low fat, oat-containing products, e.g.,
muffins, cereals, and breads, to qualify for this health claim. The
petitioner provided several examples of meals, developed on the basis
of U.S. Dietary Guidelines, that demonstrated how 40 g of oat bran and
60 g of oatmeal, providing 3 g of -glucan soluble fiber, could
be incorporated into a diet that is consistent with dietary guidelines
(Ref. 1, pp. 43-54).
The agency agrees that, based on Davidson et al. (Ref. 15), the
metaanalysis (Ref. 33), and other studies that reported the amount of
-glucan soluble fiber in oat products, 3 or more grams of oat
-glucan soluble fiber were associated with significant
reductions in serum cholesterol. The agency also agrees that not all
oat bran or oatmeal-containing products that might otherwise qualify
for this claim contain that amount per RACC of oat product. Based on
nutrient composition data presented in the petition (Ref. 1, pp. 38-
39), only oat bran hot and cold cereals contain 3 g -glucan
soluble fiber would qualify for this proposed health claim. Thus,
limiting eligibility for the claim to products with 3 g -
glucan soluble fiber would have the unintended effect of eliminating a
number of low fat, oat-containing products, e.g., oatmeal cereals,
oatmeal waffles, oat bran muffins, and oatmeal breads, from bearing an
oatmeal or oat bran and CHD health claim.
The petition states that the most common oat food forms are oat
bran and oatmeal consumed as hot cereals (Ref. 1, p.33). The mean daily
dietary intake by oat consumers of oatmeal and oat bran hot cereals is
43.3 g (dry weight basis) and the median intake is 40.1 g (Ref. 1, p.
33). The petition states that the 90th and 95th percentiles of intake
are 71.3 and 84.2 g (dry weight basis) per day, respectively.
Therefore, it is reasonable to assume that a person could consume a
total of, or more than, 40 g oat bran, 60 g oatmeal, or a combination
of the
[[Page 309]]
two that provides 3 g -glucan soluble fiber if the oat
products are consumed over the course of a day.
The agency has generally made the assumption that a daily food
consumption pattern includes three meals and a snack (see 58 FR 2302 at
2379, January 6, 1993). Therefore, one approach to determining the
qualifying levels of oat bran, oatmeal, and oat -glucan
soluble fiber for a CHD health claim is to divide the effective levels
of these substances by four eating occasions per day. Using this
approach, an oat bran product would have to provide at least 10 g of
oat bran and 0.75 g -glucan soluble fiber, and an oatmeal
product would have to provide at least 15 g of oatmeal and 0.75 g
-glucan soluble fiber per RACC in order to qualify to bear an
oat and CHD health claim. However, considering that the mean daily
dietary intake of oatmeal and oat bran is 43 g, and that that amount is
consumed mostly in the form of hot cereal, and considering the nature
of this food, it is not expected that people will consume oat-
containing products 4 times a day. The agency is persuaded by the
petitioner's argument that oat products can reasonably be expected to
be consumed 3 times a day, being incorporated into a variety of
products. Thus, an oat bran-containing product would have to provide no
less than 13 g oat bran and 1 g -glucan soluble fiber per
RACC, and an oatmeal- containing product would have to provide no less
than 20 g oatmeal and 1 g -glucan soluble fiber. Therefore,
the agency tentatively finds that use of 13 g oat bran and 20 g oatmeal
that provide 1 g -glucan soluble fiber as the qualifying
criteria for this proposed rule is appropriate and is proposing these
levels in this document.
The proposed qualifying requirement of 1 g -glucan soluble
fiber per RACC of oat bran or oatmeal-containing product is higher than
the amount of soluble fiber that is required for a food to qualify to
bear the fruits, vegetables, and grain products and CHD health claim
(Sec. 101.77). Under Sec. 101.77(c)(ii)(C), a food need only contain,
without fortification, 0.6 g soluble fiber per RACC. In the preamble to
the 1993 dietary fiber and CVD final rule, the agency explained that
the 0.6 g of soluble fiber was based in part on the recommendation by
the LSRO expert panel that 25 percent of the recommended daily intake
of fiber be soluble fiber (58 FR 2552 at 2573 and 2574). The agency
also stated that the 0.6 g soluble fiber is consistent with the
definition of a ``good source'' of a nutrient (i.e., 10 percent of the
daily reference value (DRV)). The agency explained that the 10 percent
level is deemed useful and appropriate because very few foods could
naturally meet the requirement for a ``high'' source of soluble fiber.
The current dietary guidance recommendations of five or more servings
of fruits and vegetables and six or more servings of grain products
daily, if followed, would likely result in intakes of soluble fiber
close to or exceeding the recommended daily intake of 6 g (58 FR 2552
at 2574). Thus, the 0.6 g of soluble fiber was intended to allow a
number of fruits, vegetables, and grain products to qualify. The agency
stated that without this alternate level very few fruits, vegetables,
and grain products would qualify for the health claim (58 FR 2552 at
2574).
Based on the scientific evidence reviewed in this document, higher
daily intakes of oat bran and oatmeal (about 40 g and 60 g,
respectively) that provided 3 g/d or more of -glucan soluble
fiber were associated with significant cholesterol-lowering benefits
(Refs. 15 and 33). As discussed above, it is reasonable to assume that
oat bran and oatmeal would likely not be consumed in more than three
eating occasions per day. Therefore, the agency tentatively finds that
the proposed criterion that the oat bran or oatmeal provide 1 g
-glucan soluble fiber per RACC is appropriate for this health
claim. The agency is asking for comments on this tentative
determination.
In Sec. 101.81(c)(2)(iii)(B), the agency is proposing, consistent
with other authorized heart disease health claims, that foods bearing
the health claim meet requirements for ``low saturated fat,'' ``low
cholesterol,'' and ``low fat.'' In the preamble to the final rule on
fruits, vegetables, and grain products and heart disease (Sec. 101.77,
58 FR 2552 at 2572), the agency stated that populations with diets rich
in these low saturated fat and low cholesterol foods experience many
health advantages, including lower rates of heart disease. In the
preamble to the proposed rule on dietary lipids and heart disease (56
FR 60727 at 60739), the agency stated that while total fat is not
directly linked to increased risk of CHD, it may have significant
indirect effects. Foods that are low in total fat facilitate reductions
in intakes of saturated fat and cholesterol to recommended levels.
Therefore, the agency tentatively concludes that proposed
Sec. 101.81(c)(2)(iii)(B) sets forth an appropriate requirement for
food to be eligible to bear the oatmeal and oat bran/CHD claim.
E. Optional Information
FDA is proposing in Sec. 101.81(d)(1) that the claim may state that
the development of heart disease depends on many factors and,
consistent with authorized CHD health claims, may list the risk factors
for heart disease that are listed in Secs. 101.75(d)(1) and
101.77(d)(1). The agency is also proposing, in response to the
petition, that the claim may provide additional information about the
benefits of exercise and body weight management. This additional
information can provide a context that is useful for an understanding
of the relationship between oat bran and oatmeal and heart disease, but
manufacturers should be cautioned that it should not be presented in a
way that is misleading to the consumer.
In proposed Sec. 101.81(d)(2), consistent with Secs. 101.75(d)(2)
and 101.77(d)(2), FDA is providing that the claim may state that the
relationship between a diet high in oat bran or oatmeal and reduced
risk of heart disease is through the intermediate link of ``blood
cholesterol'' or ``blood total cholesterol'' and ``LDL- cholesterol.''
The relationship between oat bran or oatmeal and reduced blood total
cholesterol and LDL-cholesterol is supported by the scientific evidence
presented in this proposal.
In Sec. 101.81(d)(3), the agency is proposing that, consistent with
Secs. 101.75(d)(3) and 101.77(d)(3), the claim may include information
from Sec. 101.81(a) and (b). These paragraphs summarize information
regarding the relationship between diets high in oat bran or oatmeal
and the risk of CHD and about the significance of that relationship.
This information helps to convey the seriousness of CHD and the role
that a diet high in oat bran and oatmeal can play to help reduce the
risk of CHD.
In Sec. 101.81(d)(4), the agency is proposing that the claim may
state that oat bran or oatmeal are good sources of dietary fiber,
particularly soluble fiber. In referring to the fiber components the
claim may use the terms ``fiber,'' ``dietary fiber,'' and ``soluble
fiber.'' If the term ``soluble fiber'' is used in the claim, the
declaration of soluble fiber content is required. This proposed
provision is consistent with Sec. 101.9(c)(6)(i)(A), which states that
the declaration of soluble fiber on the nutrition label is voluntary,
except that when a claim is made on the label or in labeling about
soluble fiber, label declaration is required.
The agency is proposing that the claim may include any of the
optional information authorized to be included
[[Page 310]]
in Secs. 101.75(d)(5), (d)(6), and (d)(7) and 101.77(d)(5), (d)(6), and
(d)(7). The health claim may state that diets high in oat bran or
oatmeal and low in saturated fat and cholesterol are part of a dietary
pattern that is consistent with dietary guidelines for Americans. The
claim may state that individuals with elevated serum lipids should
consult their physicians for medical advice and treatment and may
include information on the prevalence of CHD in the United States. The
intent of this information is to provide consumers with information
that will help them understand the seriousness of CHD in the United
States and to help them understand that diets high in oat bran or
oatmeal are consistent with dietary guidelines.
In proposed Sec. 101.81(d)(8), in response to the petition, the
claim may provide information about the amount of food, such as bowls,
servings or slices, to be consumed daily. This information may give the
consumer a better perspective on how much oat bran and oatmeal is
needed to help lower serum cholesterol levels.
F. Model Health Claims
In proposed Sec. 101.81(e), FDA is providing model health claims to
illustrate the requirements of new Sec. 101.81. FDA emphasizes that
these model health claims are illustrative only. These model claims
illustrate the required, and some of the optional, elements of the
proposed rule. If the agency authorizes a claim about the relationship
between oat products and CHD, manufacturers will be free to design
their own claim so long as it is consistent with Sec. 101.81(c).
In Sec. 101.81(e)(1), the model claim illustrates all of the
required elements of the proposed health claim. The claim states
``Diets high in [oat bran or oatmeal] and low in saturated fat and
cholesterol may reduce the risk of heart disease.''
In Sec. 101.81(e)(2), the model claims provide examples of a
shortened claim with the required referral statement.
VI. Environmental Impact
The agency has determined under 21 CFR 25.24(a)(11) that this
action is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
VII. 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 Regulatory Flexibility Act requires analyzing options for
regulatory relief for small businesses. FDA finds that this proposed
rule is not a significant rule as defined by Executive Order 12866. In
accordance with the Regulatory Flexibility Act, the agency certifies
that the proposed rule will not have a significant impact on a
substantial number of small businesses.
This proposed rule will not result in significant costs to
industry. Some oat manufacturers are currently using FDA's approved
health claim regarding the benefits of fruits, vegetables, and grain
products. This proposed health claim will allow them to specifically
highlight the benefits of oat bran and oatmeal. Consumers will benefit
from the additional information regarding the relationship of oat
products and CHD.
VIII. Paperwork Reduction Act
FDA tentatively concludes that this proposed rule contains no
reporting, recordkeeping, labeling, or other third party disclosure
requirements; thus there is no ``information collection'' necessitating
clearance by the Office of Management and Budget. However, to ensure
the accuracy of this tentative conclusion, FDA is seeking comment on
whether this proposed rule to permit health claims on the association
between oat products (i.e., oat bran and oatmeal) and reduced risk of
CHD imposes any paperwork burden.
IX. Effective Date
FDA is proposing to make these regulations effective upon
publication in the Federal Register of a final rule based upon this
proposal.
X. Comments
Interested persons may, on or before April 3, 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.
XI. 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. The Quaker Oats Co., ``Petition for Health Claim--Oat Products
and Coronary Heart Disease,'' March 22, 1995 [CP1].
2. Scarbrough, F. Edward, CFSAN, FDA, Letter to Ted Moeller, Quaker
Oats Co., June 29, 1995.
3. DHHS, Public Health Service (PHS), ``The Surgeon General's Report
on Nutrition and Health,'' U.S. Government Printing Office,
Washington, DC, pp. 83-137, 1988.
4. National Research Council, National Academy of Sciences, ``Diet
and Health,'' National Academy Press, Washington, DC, pp. 291-309
and 529-547, 1989.
5. DHHS, PHS, and the National Institutes of Health (NIH),
``National Cholesterol Education Program: Report of the Expert Panel
on Detection, Evaluation, and Treatment of High Blood Cholesterol in
Adults,'' NIH, Bethesda, MD, pp. 1-79, 1989.
6. DHHS, PHS, and NIH, ``National Cholesterol Education Program:
Population Panel Report,'' Bethesda, MD, pp. 1-27, 1989.
7. LSRO, FASEB, ``Physiological Effects and Health Consequences of
Dietary Fiber,'' Bethesda, MD, 1987.
8. Anderson, J. W., N. H. Gilinsky, D. A. Deakins, S. F. Smith, D.
S. O'Neal, D. W. Dillon, and P. R. Oeltgen, ``Lipid Responses of
Hypercholesterolemic Men to Oat-bran and Wheat Bran Intake,''
American Journal of Clinical Nutrition, 54:678-683, 1991.
9. Anderson, J. W., D. B. Spencer, C. C. Hamilton, S. F. Smith, J.
Tietyen, C. A. Bryant, and P. Oeltgen, ``Oat-bran Cereal Lowers
Serum Total and LDL Cholesterol in Hypercholesterolemic Men,''
American Journal of Clinical Nutrition, 52:495-499, 1990.
10. Bartram, P., S. Gerlach, W. Scheppach, F. Keller, and H. Kasper,
``Effect of a Single Oat Bran Cereal Breakfast on Serum Cholesterol,
Lipoproteins, and Apolipoproteins in Patients with
Hyperlipoproteinemia Type IIa,'' Journal of Parenteral and Enteral
Nutrition, 16:533-537, 1992.
11. Beling, S., L. Detrick, and W. Castelli, ``Serum Cholesterol
Response to a Processed Oat Bran Cereal Among Hypercholesterolemics
on a Fat-modified Diet,'' unpublished clinical trial submitted by
the Quaker Oats Co., 1991.
12. Braaten, J. T., P. J. Wood, F. W. Scott, M. S. Wolyneta, M. K.
Lowe, P. Bradley-White, M. W. Collins, ``Oat Beta-glucan Reduces
Blood Cholesterol Concentration in Hypercholesterolemic Subjects,''
European Journal of Clinical Investigation, 48:465-474, 1994.
[[Page 311]]
13. Bremer, J. M., R. S. Scott, and C. J. Lintott, ``Oat Bran and
Cholesterol Reduction: Evidence Against Specific Effect,'' Australia
and New Zealand Journal of Medicine, 21:422-426, 1991.
14. Cara, L., C. Cubois, P. Borel, M. Armand, M. Senft, H. Portugal,
A. M. Pauli, P. M. Bernard, and D. Lairon, ``Effects of Oat Bran,
Rice Bran, Wheat Fiber, and Wheat Germ on Postprandial Lipemia in
Healthy Adults,'' American Journal of Clinical Nutrition, 55:81-88,
1992.
15. Davidson, M. H., L. D. Dugan, J. H. Burns, J. Bova, K. Story,
and K. B. Drennan, ``The Hypocholesterolemic Effects of Beta-glucan
in Oatmeal and Oat Bran--a Dose-Controlled Study,'' Journal of the
American Medical Association, 265(14):1833-1839, 1991.
16. Demark-Wahnefried, W., J. Bowering, and P. S. Cohen, ``Reduced
Serum Cholesterol with Dietary Change Using Fat-Modified and Oat
Bran Supplemented Diets,'' Journal of the American Dietetic
Association, 90:223-229, 1990.
17. Gold, K. V., and D. M. Davidson, ``Oat Bran as a Cholesterol-
reducing Dietary Adjunct in a Young, Healthy Population,'' Western
Journal of Medicine, 148:299-302, 1988.
18. Gormley, T. R., J. Kevany, J. P. Egan, and R. McFarland,
``Investigation of the Potential of Porridge as a
Hypocholesterolemic Agent,'' Israel Journal of Food Science and
Technology, 2:85-91, 1978.
19. He, J., M. J. Klag, P. K. Whelton, J-P. Mo, J-Y. Chen, P-S. Mo,
and G-Q. He, ``Oats and Buckwheat Intakes and Cardiovascular Disease
Risk Factors in an Ethnic Minority of China,'' American Journal of
Clinical Nutrition, 61:366-372, 1995.
20. Hegsted, M., M. M. Windhauser, K. Morris, and S. B. Lester,
``Stabilized Rice Bran and Oat Bran Lower Cholesterol in Humans,''
Nutrition Research, 13:387-398, 1993.
21. Kahn, R. F., K. W. Davidson, J. Garner, and R. S. McCord, ``Oat
Bran Supplementation for Elevated Serum Cholesterol,'' Family
Practice Research Journal, 10:37-46, 1990.
22. Kastan, H. H., S. Stern, D. J. A. Jenkins, K. Hay, N. Marcon, S.
Minkin, and W. R. Bruce, ``Wheat Bran and Oat-bran Supplements'
Effects on Blood Lipids and Lipoproteins,'' American Journal of
Clinical Nutrition, 55:976-980, 1992.
23. Keenan, J. M., J. B. Wenz, S. Myers, C. Ripsin, and Z. Huang,
``Randomized Controlled Cross-over Trial of Oat Bran in
Hypercholesterolemic Subjects,'' Journal of Family Practice, 33:600-
608, 1991.
24. Kelley, M. J., J. Hoover-Plow, J. F. Nichols-Bernhard, L.S.
Verity, and H.B. Brewer, ``Oat Bran Lowers Total and Low-Density
Lipoprotein Cholesterol but Not Lipoprotein in Exercising Adults
with Borderline Hypercholesterolemia,'' Journal of the American
Dietetic Association, 94:1419-1421, 1994.
25. Kestin, M., R. Moss, P. M. Clifton, and P. J. Nestel,
``Comparative Effects of Three Cereal Brans on Plasma Lipids, Blood
Pressure, and Glucose Metabolism in Mildly Hypercholesterolemic
Men,'' American Journal of Clinical Nutrition, 52:661-666, 1990.
26. Leadbetter, J., M. J. Ball, and J. I. Mann, ``Effects of
Increasing Quantities of Oat Bran in Hypercholesterolemic People,''
American Journal of Clinical Nutrition, 54:841-845, 1991.
27. Lepre, F., and S. Crane, ``Effect of Oat Bran on Mild
Hyperlipidaemia,'' The Medical Journal of Australia, 157:305-306,
1992.
28. Mackay, S., and M. J. Ball, ``Do Beans and Oat Bran Add to the
Effectiveness of a Low-fat Diet?'', European Journal of Clinical
Nutrition, 46:641-648, 1992.
29. Marlett, J. A., K. B. Hosig, N. W. Vollendorf, F. L. Shinnick,
V.S. Haack, and J. A. Story, ``Mechanism of Serum Cholesterol
Reduction by Oat Bran,'' Hepatology, 20:1450-1457, 1994.
30. O'Brien, L. T., R. J. Barnard, and J. A. Hall, ``Effects of a
High-Complex-Carbohydrate Low-cholesterol Diet plus Bran Supplement
on Serum Lipids,'' Journal of Applied Nutrition, 37:26-34, 1985.
31. O'Kell, R. T., and A. A. Duston, ``Lack of Effect of Dietary
Oats on Serum Cholesterol,'' Missouri Medicine, 85:726-728, 1988.
32. Poulter, N., C. L. Chang, A. Cuff, C. Poulter, P. Sever, and S.
Thom, ``Lipid Profiles after the Daily Consumption of an Oat-Based
Cereal: A Controlled Crossover Trial,'' American Journal of Clinical
Nutrition, 58:66-69, 1993.
33. Ripsin, C. M., J. M. Keenan, D. R. Jacobs, P. J. Elmer, R. R.
Welch, L. Van Horn, K. Liu, W. H. Turnbull, F. W. Thye, M. Kestin,
M. Hegsted, D. M. Davidson, M. H. Davidson, L. D. Dugan, W. Demark-
Wahnefried, and S. Beling, ``Oat Products and Lipid Lowering--A
Metaanalysis,'' Journal of the American Medical Association,
267:3317-3325, 1992.
34. Saudia, T. L., B. R. Barfield, and J. Barger, ``Effect of Oat
Bran Consumption on Total Serum Cholesterol Levels in Healthy
Adults,'' Military Medicine, 157:567-568, 1992.
35. Spiller, G. A., J. W. Farquhar, J. E. Gates, and S. F. Nichols,
``Guar Gum and Plasma Cholesterol, Effect of Guar Gum and an Oat
Fiber Source on Plasma Lipoproteins and Cholesterol in
Hypercholesterolemic Adults,'' Arteriosclerosis and Thrombosis,
11:1204-1208, 1991.
36. Stewart, F. M., J. M. Neutze, and R. Newsome-White, ``The
Addition of Oat Bran to a Low Fat Diet Has No Effect on Lipid Values
in Hypercholesterolaemic Subjects,'' New Zealand Medical Journal,
106:398-340, 1992.
37. Swain, J. F., I. L. Rouse, C. B. Curley, and F. M. Sacks,
``Comparison of the Effects of Oat Bran and Low Fiber Wheat on Serum
Lipoprotein Levels and Blood Pressure,'' New England Journal of
Medicine, 322:147-152, 1990.
38. Torronen, R., L. Kansanen, M. Uusitupa, O. Hanninen, O.
Myllymaki, H. Harkonen, and Y. Malkki, ``Effects of an Oat Bran
Concentrate on Serum Lipids in Free-Living Men with Mild to Moderate
Hypercholesterolaemia,'' European Journal of Clinical Nutrition,
46:621-627, 1992.
39. Turnbull, W. H., and A. R. Leeds, ``Reduction of Total and LDL-
cholesterol in Plasma by Rolled Oats,'' Journal of Clinical
Nutrition and Gastroenterology, 2:1-4, 1987.
40. Grover, S. A., M. Abrahamowicz, L. Joseph, C. Brewer, L. Coupal,
S. Suissa, ``The Benefits of Treating Hyperlipidemia to Prevent
Coronary Heart Disease,'' Journal of the American Medical
Association, 267:816-822, 1992.
41. Uusitupa, M. I. J., E. Ruuskanen, E. Makinen, J. Laitinen, E.
Toskala, K. Kervinen, and A. Kesaniemi, ``A Controlled Study on the
Effect of Beta-Glucan-Rich Oat Bran on Serum Lipids in
Hypercholesterolemic Subjects: Relation to Apolipoprotein E
Phenotype,'' Journal of the American College of Nutrition, 11:651-
659, 1992.
42. Van Horn, L., L. A. Emidy, K. Liu, Y. Liao, C. Ballew, J. King,
and J. Stamler, ``Serum Lipid Response to a Fat-Modified, Oatmeal-
Enhanced Diet,'' Preventive Medicine, 17:377-386, 1988.
43. Van Horn, L., K. Liu, D. Parker, L. Emidy, Y. Liao, W. H. Pan,
D. Giumetti, J. Hewitt, and J. Stamler, ``Serum Lipid Response to
Oat Product Intake with a Fat-Modified Diet,'' Journal of the
American Dietetic Association, 86:759-764, 1986.
44. Van Horn, L., A. Moag-Stahlberg, K. Liu, C. Ballew, K. Ruth, R.
Hughes, J. Stamler, ``Effects on Serum Lipids of Adding Instant Oats
to Usual American Diets,'' American Journal of Public Health,
81:183-188, 1991.
45. Whyte, J., R. McArthur, D. Topping, and P. Nestel, ``Oat Bran
Lowers Plasma Cholesterol in Mildly Hypercholesterolemic Men,''
Journal of the American Dietetic Association, 92:446-449, 1992.
46. Zhang, J. G. Hallmans, H. Andersson, I. Bosaeur, P. Aman, P.
Tidehag, R. Stenling, E. Lundin, and S. Dahlgren, ``Effect of Oat
Bran on Plasma Cholesterol and Bile Acid Excretion in Nine Subjects
With Ileostomies,'' American Journal of Clinical Nutrition, 56:99-
105, 1992.
47. Sempos, C. T., J. I. Cleeman, M. D. Carroll, C. L. Johnson, P.
S. Bachorik, D. J. Gordon, V. L. Burt, R. R. Briefel, C. D. Brown,
K. Lippel, and B. M. Rifkind, ``Prevalence of High Blood Cholesterol
Among U.S. Adults. An Update Based on Guidelines from the Second
Report of the National Cholesterol Education Program Adult Treatment
Panel,'' Journal of the American Medical Association, 269:3009-3014,
1993.
48. Ross, R., ``Atherosclerosis,'' in Cecil--Textbook of Medicine,
edited by Wyngaarden, J. B., L. H. Smith, and J. C. Bennett,
Harcourt Brace Jovanevich, Inc., Philadelphia, p. 293-295, 1992.
[[Page 312]]
49. Saltsman, Joyce J., CFSAN, FDA, Memorandum to file, May 19,
1995.
50. DHHS and USDA, ``Nutrition and Your Health: Dietary Guidelines
for Americans,'' U.S. Gov. Printing Office, 273-930, 1990.
51. Schultz, William B., FDA, Letter to John R. Cady, National Food
Processors Association, May 11, 1995.
List of Subjects in 21 CFR Part 101
Food labeling, Incorporation by reference, Nutrition, Reporting and
recordkeeping requirements.
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 101 be amended as follows:
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 is revised to read as
follows:
Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act
(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 501,
502, 505, 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 331, 342, 343, 348, 351, 352, 355, 371).
2. New Sec. 101.81 is added to subpart E to read as follows:
Sec. 101.81 Health claims: Oat products and risk of coronary heart
disease.
(a) Relationship between diets high in oatmeal and oat bran and the
risk of coronary heart disease. (1) Cardiovascular disease means
diseases of the heart and circulatory system. Coronary heart disease
(CHD) is the most common and serious form of cardiovascular disease and
refers to diseases of the heart muscle and supporting blood vessels.
High blood total cholesterol and low density lipoprotein (LDL)-
cholesterol levels are associated with increased risk of developing
CHD. High CHD rates occur among people with high total cholesterol
levels of 240 milligrams per deciliter (mg/dL) (6.21 millimoles per
liter (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13
mmol/L) or above. Borderline high risk total cholesterol levels range
from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36
to 4.11 mmol/L) of LDL-cholesterol. The scientific evidence establishes
that diets high in saturated fat and cholesterol are associated with
increased levels of blood total- and LDL-cholesterol and, thus, with
increased risk of coronary heart disease.
(2) Populations with a low incidence of coronary heart disease tend
to have relatively low blood total cholesterol and LDL-cholesterol
levels. These populations also tend to have dietary patterns that are
not only low in total fat, especially saturated fat, and cholesterol
but are also relatively high in fiber-containing fruits, vegetables,
and grain products, such as oatmeal and oat bran.
(3) Oat bran and oatmeal are low in saturated fat and cholesterol
and a good source of soluble fiber. Scientific evidence demonstrates
that diets high in these oat products are associated with reduced blood
total and LDL-cholesterol levels.
(b) Significance of the relationship between diets high in oatmeal
and oat bran and the risk of coronary heart disease. (1) Coronary heart
disease is a major public health concern in the United States. It
accounts for more deaths than any other disease or group of diseases.
Early management of risk factors for coronary heart disease is a major
public health goal that can assist in reducing the risk of coronary
heart disease. High blood total and LDL-cholesterol are major
modifiable risk factors in the development of CHD.
(2) Intakes of saturated fat exceed recommended levels in the diets
of many people in the United States. Intakes of cholesterol are, on
average, at or above recommended levels. One of the major public health
recommendations relative to coronary heart disease risk is to consume
less than 10 percent of calories from saturated fat and an average of
30 percent or less of total calories from all fat. Recommended daily
cholesterol intakes are 300 mg or less per day. Scientific evidence
demonstrates that diets high in oat bran and oatmeal and low in
saturated fat and cholesterol are associated with lower blood total and
LDL-cholesterol levels.
(c) Requirements. (1) All requirements set forth in Sec. 101.14
shall be met.
(2) Specific requirements. (i) Nature of the claim. A health claim
associating diets high in oatmeal or oat bran with reduced risk of
coronary heart disease may be made on the label or labeling of a food
described in paragraph (c)(2)(iii) of this section, provided that:
(A) The claim states that oatmeal or oat bran ``may'' or ``might''
reduce the risk of heart disease.
(B) In specifying the disease, the claim uses the following terms:
``heart disease'' or ``coronary heart disease.''
(C) The claim states that:
(1) Diets high in oatmeal or oat bran may reduce the risk of
coronary heart disease; and
(2) The effect of dietary intake of oatmeal or oat bran on the risk
of coronary heart disease is particularly evident when these foods are
consumed as part of a diet that is low in saturated fat and
cholesterol.
(D) The claim does not attribute any degree of risk reduction for
coronary heart disease to diets high in oat bran or oatmeal and low in
saturated fat and cholesterol.
(E) The claim does not imply that consumption of oat bran or
oatmeal is the only recognized means of achieving a reduced risk of
coronary heart disease.
(ii) Presentation of the claim. All of the elements listed in
paragraph (c)(2)(i) of this section must be included in one
presentation of the claim displayed prominently on the label or in the
labeling on which the claim appears. Other presentations of the claim
on that label or labeling, including on the principal display panel,
need not include the information in paragraph (c)(2)(i)(C)(2) of this
section provided that, displayed prominently and in immediate proximity
to a shortened statement of the claim, the following referral statement
is used: ``See __________ for more information'' with the blank filled
in with the identity of the panel on which is presented the statement
of the claim that includes all of the elements in paragraph (c)(2)(i)
of this section.
(A) The referral statement ``See [appropriate panel] for more
information'' shall be in easily legible boldface print or type, in
distinct contrast to other printed or graphic matter, that is no less
than that required by Sec. 101.105(i) for net quantity of contents,
except where the size of the claim is less than 2 times the required
size of the net quantity of contents statement, in which case the
referral statement shall be no less than one-half the size of the claim
but no smaller than one-sixteenth of an inch.
(B) The referral statement shall be immediately adjacent to any
presentation of the health claim that does not include all of the
elements in paragraph (c)(2)(i) of this section, and there may be no
intervening material between the claim and the referral statement. If
the abbreviated health claim appears on more than one panel of the
label, the referral statement shall be adjacent to the claim on each
panel except for the panel that bears the full health claim, where it
may be omitted.
(iii) Nature of the food. (A) The food shall contain no less than
20 g oatmeal or 13 g oat bran that provides, without fortification, at
least 1 g of -glucan soluble fiber per reference amount
customarily consumed. Beta-glucan will be determined by method No.
992.28 from the ``Official Methods of Analysis of the Association of
Official Analytical Chemists,'' 15th ed. (1993), which is
[[Page 313]]
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR
part 51. Copies may be obtained from the Association of Official
Analytical Chemists, 481 North Frederick Ave., suite 500, Gaithersburg,
MD 20877-2504, or may be examined at the Center for Food Safety and
Applied Nutrition's Library, 200 C St. SW., rm. 3321, Washington, DC,
or at the Office of the Federal Register, 800 North Capitol St. NW.,
suite 700, Washington, DC;
(B) The food shall meet the nutrient content requirements in
Sec. 101.62 for a ``low saturated fat,'' ``low cholesterol,'' and ``low
fat'' food.
(d) Optional information. (1) The claim may state that the
development of heart disease depends on many factors and may identify
one or more of the following risk factors for heart disease about which
there is general scientific agreement: A family history of coronary
heart disease; elevated blood total and LDL-cholesterol; excess body
weight; high blood pressure; cigarette smoking; diabetes; and physical
inactivity. The claim may also provide additional information about the
benefits of exercise and management of body weight to help lower the
risk of heart disease.
(2) The claim may state that the relationship between intake of oat
bran and oatmeal and reduced risk of heart disease is through the
intermediate link of ``blood cholesterol'' or ``blood total- and LDL-
cholesterol.''
(3) The claim may include information from paragraphs (a) and (b)
of this section, which summarize the relationship between oat bran or
oatmeal and coronary heart disease and the significance of the
relationship.
(4) The claim may state that oat bran and oatmeal are good sources
of dietary fiber, particularly soluble fiber. In referring to the oat
fiber component, the claim may use the terms ``fiber,'' ``dietary
fiber,'' or ``soluble fiber.'' If the claim uses the term soluble
fiber, the total soluble fiber content shall be declared in the
nutrition information panel, consistent with Sec. 101.9(c)(6)(i)(A).
(5) The claim may state that a diet low in saturated fat and
cholesterol and high oatmeal or oat bran is consistent with ``Nutrition
and Your Health: Dietary Guidelines for Americans,'' U.S. Department of
Agriculture (USDA) and Department of Health and Human Services (DHHS),
Government Printing Office (GPO);
(6) The claim may state that individuals with elevated blood total-
and LDL-cholesterol should consult their physicians for medical advice
and treatment. If the claim defines high or normal blood total- and
LDL-cholesterol levels, then the claim shall state that individuals
with high blood cholesterol should consult their physicians for medical
advice and treatment;
(7) The claim may include information on the number of people in
the United States who have heart disease. The sources of this
information shall be identified, and it shall be current information
from the National Center for Health Statistics, the National Institutes
of Health, or ``Nutrition and Your Health: Dietary Guidelines for
Americans,'' USDA and DHHS, GPO;
(8) The claim may provide information about the amounts of oat-
containing food, e.g., bowls, servings, slices, to be consumed in a
day.
(e) Model health claim. The following model health claims may be
used in food labeling to describe the relationship between oat bran and
oatmeal and reduced risk of heart disease:
(1) The following is an example of a full claim: Diets high in [oat
bran/oatmeal] and low in saturated fat and cholesterol may reduce the
risk of heart disease.
(2) The following are examples of a shortened claim:
(A) [Front panel] Diets high in [oat bran or oatmeal] may reduce
the risk of heart disease
See [side/back] panel for more information
(B) [Front panel] Eating [oat bran or oatmeal] daily may reduce
heart disease risk
See [side/back] panel for more information
Dated: December 22, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
Note: The following tables will not appear in the Code of
Federal Regulations.
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[FR Doc. 96-29 Filed 1-3-96; 8:45 am]
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Complete official Federal Register PDF
FR Doc. 96-115 Automatic Extension of Time for Filing Individual Income Tax Returns
[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Proposed Rules]
[Pages 338-339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-115]
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DEPARTMENT OF THE TREASURY
26 CFR Parts 1 and 301
[IA-41-93]
RIN 1545-AS04
Automatic Extension of Time for Filing Individual Income Tax
Returns
AGENCY: Internal Revenue Service (IRS), Treasury.
ACTION: Notice of proposed rulemaking by cross reference to temporary
regulations and notice of public hearing.
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SUMMARY: In the Rules and Regulations section of this issue of the
Federal Register, the IRS is issuing temporary regulations that reflect
the new procedures for obtaining an automatic extension of time to file
an individual income tax return. The text of the temporary regulations
also serves as the comment document for this notice of proposed
rulemaking. This document also provides notice of a public hearing on
these proposed regulations.
DATES: Written comments must be received by April 1, 1996. Outlines of
topics to be discussed at the public hearing scheduled for May 8, 1996,
beginning at 10:00 a.m. must be received by April 1, 1996.
ADDRESSES: Send submissions to: CC:DOM:CORP:R (IA-41-93), 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 (IA-41-93), Courier's
Desk, Internal Revenue Service, 1111 Constitution Avenue, NW.,
Washington, DC. The public hearing will be held in the IRS Auditorium.
FOR FURTHER INFORMATION CONTACT: Concerning the regulations, Margaret
A. Owens, 202-622-6232 (not a toll-free number). Concerning submissions
and the public hearing, Michael Slaughter, 202-622-7190 (not a toll-
free number).
SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act
The collection of information contained in this notice of proposed
rulemaking has been submitted to the Office of Management and Budget
for review in accordance with the Paperwork Reduction Act of 1995 (44
U.S.C. 3507).
Comments on the collection of information should be sent to the
Office of Management and Budget, Attn: Desk Officer for the Department
of the Treasury, Office of Information and Regulatory Affairs,
Washington, DC 20503, with copies to the Internal Revenue Service,
Attn: IRS Reports Clearance Officer, T:FP, Washington, DC 20224.
Comments on the collection of information should be received by March
4, 1996.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless the collection of
information displays a valid control number.
The collection of information is in Sec. 1.6081-4T(a). This
information is required by the IRS to monitor the filing of individual
income tax returns. This information will be used to determine which
individuals need automatic 4-month extensions of time to file. The
likely respondents are individuals or households. Responses to this
collection of information are required to obtain a benefit (an
automatic 4-month extension of time to file an individual income tax
return).
Books or records relating to a collection of information must be
retained as long as their contents may become material in the
administration of any internal revenue law. Generally, tax returns and
tax return information are confidential, as required by 26 U.S.C. 6103.
Estimates of the reporting burden in this Notice of Proposed
Rulemaking will be reflected in the burden of Form 4868.
Background
The temporary regulations published in the Rules and Regulations
section of this issue of the Federal Register contain amendments to the
Income Tax Regulations (26 CFR part 1) and the Regulations on Procedure
and Administration (26 CFR part 301). The temporary regulations provide
rules relating to obtaining an automatic 4-month extension of time to
file an individual income tax return. The text of the temporary
regulations also serves as the text of these proposed regulations. The
preamble to the temporary regulations explains these proposed
regulations.
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 also has been determined
that section 553(b) of the Administrative Procedure Act (5 U.S.C.
chapter 5) and the Regulatory Flexibility Act (5 U.S.C. chapter 6) do
not apply to these rules, and therefore, a Regulatory Flexibility
Analysis is not required. Pursuant to section 7805(f) of the Internal
Revenue Code, a copy of this notice of proposed rulemaking will be
submitted to the Chief Counsel for
[[Page 339]]
Advocacy of the Small Business Administration for comment on its impact
on small business.
Comments and Public Hearing
Before these proposed regulations are adopted as final regulations,
consideration will be given to any written comments (a signed original
and eight (8) copies) that are submitted timely to the IRS. All
comments will be available for public inspection and copying.
A public hearing has been scheduled for May 8, 1996, at 10:00 a.m.,
at the IRS Auditorium. 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 who wish to present oral comments at the hearing must
submit written comments by April 1, 1996, and submit an outline of the
topics to be discussed and the time to be devoted to each topic (signed
original and eight (8) copies) by April 1, 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 comments has passed. Copies of the
agenda will be available free of charge at the hearing.
Drafting Information
The principal author of these regulations is Margaret A. Owens,
Office of the Assistant Chief Counsel (Income Tax & Accounting), IRS.
However, other personnel from the IRS and Treasury Department
participated in their development.
List of Subjects
26 CFR Part 1
Income taxes, Reporting and recordkeeping requirements.
26 CFR Part 301
Employment taxes, Estate taxes, Excise taxes, Gift taxes, Income
taxes, Penalties, Reporting and recordkeeping requirements.
Proposed Amendments to the Regulations
Accordingly, 26 CFR parts 1 and 301 are 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 1.6081-4 is amended by:
1. Revising paragraph (a).
2. Adding paragraph (d).
The revised and added provisions read as follows:
Sec. 1.6081-4 Automatic extension of time for filing individual income
tax returns.
[The text of proposed paragraphs (a) and (d) are the same as the text
of Sec. 1.6081-4T (a) and (d) published elsewhere in this issue of the
Federal Register].
PART 301--PROCEDURE AND ADMINISTRATION
Par. 3. The authority citation for part 301 continues to read in
part as follows:
Authority: 26 U.S.C. 7805. * * *
Par. 4. In Sec. 301.6651-1, paragraph (c)(3) is revised to read as
follows:
Sec. 301.6651-1 Failure to file tax return or to pay tax.
* * * * *
(c)(3) [The text of this proposed paragraph (c)(3) is the same as
the text of Sec. 301.6651-1T(c)(3) published elsewhere in this issue of
the Federal Register].
* * * * *
Margaret Milner Richardson,
Commissioner of Internal Revenue.
[FR Doc. 96-115 Filed 1-3-96; 8:45 am]
BILLING CODE 4830-01-U
Complete official Federal Register PDF
FR Doc. 96-108 Public Workshop on the Regulation of Radioactive Devices
[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Proposed Rules]
[Page 295]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-108]
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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.
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Federal Register / Vol. 61, No. 3 / Thursday, January 4, 1996 /
Proposed Rules
[[Page 295]]
NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 31, 32, 40 and 70
Public Workshop on the Regulation of Radioactive Devices
AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of meeting.
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SUMMARY: The NRC will hold a public workshop in Rockville, Maryland to
review the regulatory program for devices containing radioactive
materials licensed under 10 CFR Parts 30, 31, 32, 40 and 70. Interested
members of the public are welcome to attend the meeting, however, for
efficient conduct of the workshop, participation will be in the format
of a round table discussion among invited representatives of
potentially affected parties. The NRC has prepared a workshop agenda.
This and related documents are available for review prior to the
workshop and interested parties are encouraged to review this
information. The NRC will accept and consider written comments from
interested parties on this regulatory issue.
DATES: The workshop will be held on January 18, 1996 from 9:00 am to
5:00 pm. The workshop will continue, if necessary, on January 19, 1996
from 9:00 am to 12 noon. Comments on this regulatory issue should be
received no later than January 31, 1996.
ADDRESSES: The public workshop will be held in the NRC auditorium at
Two White Flint North, 11545 Rockville Pike, Rockville, Maryland.
Visitor parking around the NRC building is limited, however, the
workshop site is adjacent to the White Flint station on the Metro Red
Line. Written comments can be provided at the workshop or by January
31, 1996 to the Secretary, U.S. Nuclear Regulatory Commission,
Washington, DC 20555, Attention: Docketing and Service Branch. Copies
of the agenda and related documents can be obtained from the NRC's
Public Document Room, 2120 L Street NW, Washington DC 20037; Phone:
202-634-3273; Fax: 202-634-3343.
FOR FURTHER INFORMATION CONTACT: Francis X. Cameron, Mail Stop O-15B18,
U.S. Nuclear Regulatory Commission, Washington, DC 20555; Phone: 301-
415-1642; Fax: 301-415-3200; INTERNET:[email protected]
SUPPLEMENTARY INFORMATION: Inadequate control of radioactive devices by
licensees has lead to radioactive materials being included in metal
scrap intended for recycling (see J. Lubenau & J. Yusko, ``Radioactive
materials in Recycled Metals,'' Health Physics, 68:4, April, 1995).
Radioactive sources have been accidentally smelted in metal mills
resulting in radioactive contamination of mills, metal products and
mill byproducts. In the U.S., costs attributable to decontamination,
waste disposal and temporary mill closures following a smelting of a
radioactive source have been as much as $23,000,000 per event. There is
a risk of radiation exposure to unsuspecting workers and members of the
public. In 1990, the Commission determined that the problem needed to
be addressed and directed a rulemaking to improve oversight of
generally licensed devices. The proposed rule was published for public
comment in 1991 (56 FR 67011, 26 December 1991). In 1993, however,
finalization of the rule was deferred because of resource constraints.
Instead, the Commission directed the staff to pursue alternatives. In
1995, the Commission approved formation of a joint Agreement State--
Nuclear Regulatory Commission (NRC) Working Group to review the
regulation of all devices containing licensed radioactive materials to
assess the current regulatory program for these devices and provide
recommendations to the Commission.
The Working Group held its initial meeting October 24-25, 1995, and
a second meeting on December 19-20, 1995, in Rockville, Maryland. The
Working Group members are Robert Free, Texas and Joel Lubenau, NRC, Co-
chairs; Robin Haden, North Carolina, Martha Dibblee, Oregon; Rita
Aldrich, New York (alternate); Lloyd Bolling, NRC and John Telford,
NRC. James Yusko, Pennsylvania, is serving as liaison to the Working
Group for the Conference of Radiation Control Program Directors. James
Richardson, NRC Nuclear Safety Attache in Vienna, Austria is serving as
liaison for the International Atomic Energy Agency. At its initial
meeting, in addition to the Working Group members, 28 representatives
of the metal recycling and steel manufacturing industries, devices
vendors and users, health physics consultants and government agencies
attended. Minutes of the first and second meetings of the Working Group
and other background information are available for public inspection
and copying for a fee at the NRC Public Document Room, under the file,
``Review Group--Radioactive Devices.''
The public workshop is intended to provide an opportunity for
stakeholders to have an input into the Working Group assessment of the
need for regulatory changes and development of recommendations, as
needed, for regulatory options to improve controls of licensed devices
and assure their proper disposal. A target date of May 1996 has been
set for the Working Group to develop and finalize its recommendations.
For efficient conduct of the workshop, the meeting format will be a
round table discussion among invited representatives from affected
interests, e.g., the metal recycling industry and recycled metal
consumers, device vendors and users, Federal and state regulators and
citizen groups. The workshop will be open to the public, and the public
will be provided opportunities throughout the workshop to comment on
the issues presented for discussion.
If the Working Group recommends changes in NRC regulations and the
Commission agrees, such changes would be proposed through a subsequent
NRC public rulemaking process.
Dated at Rockville, Maryland, this 28th day of December 1995.
For the Nuclear Regulatory Commission.
Malcolm R. Knapp,
Deputy Director, Office of Nuclear Materials Safety and Safeguards.
[FR Doc. 96-108 Filed 1-3-96; 8:45 am]
BILLING CODE 7590-01-P
Complete official Federal Register PDF
FR Doc. 96-107 Areas Unusually Sensitive to Environmental Damage
[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Proposed Rules]
[Pages 342-344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-107]
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DEPARTMENT OF TRANSPORTATION
Research and Special Programs Administration
49 CFR Part 195
[Docket PS-140(b), Notice 4]
RIN 2137-AC34
Areas Unusually Sensitive to Environmental Damage
AGENCY: Research and Special Programs Administration (RSPA), DOT.
ACTION: Public workshop.
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SUMMARY: RSPA invites industry, government representatives, and the
public to a third workshop on unusually sensitive areas (USAs). The
workshop's purpose is to openly discuss the guiding principles for
determining areas unusually sensitive to environmental damage from a
hazardous liquid pipeline release. This workshop is a continuation of
the June 15-16, 1995 and October 17, 1995 workshops on USAs.
DATES: The workshop will be held on January 18, 1996 from 8:30 a.m. to
4 p.m. Persons who are unable to attend may submit written comments in
duplicate by February 5, 1996. However, persons submitting guiding
principles to be considered at the January 18 workshop must do so by
January 12, 1996. Interested persons should submit as part of their
written comments all material that is relevant to a statement of fact
or argument. Late filed comments will be considered so far as
practicable.
ADDRESSES: The workshop will be held at the U.S. Department of
Transportation, Nassif Building, 400 Seventh Street, SW, Room 6200-04,
Washington, DC. Non-federal employee visitors are admitted into the DOT
headquarters building through the southwest entrance at Seventh and E
Streets, SW. Persons who want to participate in the workshop should
call (202) 366-2392 or e-mail their name, affiliation, and phone number
to [email protected] before close of business January 12, 1996. The
[[Page 343]]
workshop is open to all interested persons but RSPA may limit
participation because of space considerations and the need to obtain a
spectrum of views. Callers will be notified if participation is not
open.
Send written comments in duplicate to the Dockets Unit, Room 8421,
Research and Special Programs Administration, U.S. Department of
Transportation, 400 Seventh Street, SW, Washington, DC 20590-0001.
Identify the docket and notice numbers stated in the heading of this
notice.
All comments and docketed materials will be available for
inspection and copying in Room 8421 between 8:30 a.m. and 4:30 p.m.
each business day. A summary of the workshop will be available from the
Dockets Unit about three weeks after the workshop.
FOR FURTHER INFORMATION CONTACT: Christina Sames, (202) 366-4561, about
this document, or the Dockets Unit, (202) 366-5046, for copies of this
document or other material in the docket.
SUPPLEMENTARY INFORMATION: 49 U.S.C. 60109 requires the Secretary of
Transportation to:
Consult with the Environmental Protection Agency and
describe areas that are unusually sensitive to environmental damage if
there is a hazardous liquid pipeline accident, and
Establish criteria for identifying each hazardous liquid
pipeline facility and gathering line, whether otherwise subject to
regulation, located in an area unusually sensitive to environmental
damage in the event of a pipeline accident.
Consistent with the President's regulatory policy (E.O. 12866),
RSPA wants to accomplish this congressional mandate at the least cost
to society. Toward this end, RSPA is seeking early public participation
in the rulemaking process by holding public workshops at which
participants, including RSPA staff, may exchange views on relevant
issues. RSPA hopes these workshops will enable government and industry
to reach a better understanding of the problem and the potential
solutions before proposed rules are issued.
On June 15 and 16, 1995, RSPA held a public workshop to openly
discuss the criteria being considered to determine USAs (60 FR 27948;
May 26, 1995). Participants included representatives from the hazardous
liquid pipeline industry; the Departments of Interior, Agriculture,
Transportation, and Commerce; the Environmental Protection Agency; non-
government agencies; and the public. Participants at the workshop
requested that additional workshops be held to further discuss this
complex topic.
On October 17, 1995, RSPA held a second public workshop on USAs (60
FR 44824; August 29, 1995). The second workshop focused on developing a
process that can be used to determine if an area is unusually sensitive
to environmental damage. The American Petroleum Institute (API)
provided information on their current research on USAs and recommended
that the final definition consider the resource to be protected, the
likelihood of a given pipeline to impact that resource, and what can be
done to reduce the risk to the resource. Other participants recommended
integrating factors concerning the likelihood of a rupture occurring
and the severity of the consequence into the USA definition.
Participants at the workshop brainstormed guiding principles that
could be used when determining if a given area is a USA and possible
topics for additional USA workshops. API volunteered to conduct mini-
workshops to discuss some of the technical issues and to bring their
findings into larger forums.
The following is a summary of the guiding principles that were
discussed at the October 17 workshop or submitted after the workshop by
members of the pipeline industry or other Federal agencies. The guiding
principles are separated into two categories: Substance and Process.
Guiding principles on substance relate to the criteria that should be
included in the USA definition. Guiding principles on process relate to
how to evaluate the criteria to be included in the USA definition, the
process to create the USA definition, and how to apply the USA
definition. The lists are not prioritized or final. The lists sometimes
include more than one recommendation which may conflict with one
another. Conflicting views are labeled a. and b. under a common number
for comparison. RSPA invites comments on these recommended guiding
principles and invites submissions of additional guiding principles.
This list and any additional guiding principles that are submitted to
the docket before January 12 will be considered at the January 18
workshop:
Substance
1. Human health and safety are primary concerns.
2. Areas where there is serious threat of contamination to a
drinking water ``zone of influence'' should be considered USAs.
3a. A resource must be subject to or threatened by irretrievable
loss or injury before it can be considered a USA. or
3b. Areas where there is serious threat of contamination to a
significant environmental or cultural resource should be considered a
USA.
4a. USAs are biological or ecological in nature and should not
include cultural, economic, or recreational resources. Cultural,
economic, or recreational resources should be designated as separate
categories and viewed as distinct entities. or
4b. Consider cultural resources and Indian tribal concerns when
defining USAs.
5. Only areas in the trajectory of a potential spill, e.g. down
gradient, should be considered when determining USAs.
6. It is expected that no pipeline operator is required to collect
natural resources field data to determine USAs.
7. Highly volatile liquid (HVL) pipelines should not be included.
Process
1. The standards and criteria for resource sensitivity should be
uniform on a national basis such that equivalent resources receive
equivalent sensitivity assessments regardless of regionally based
priorities.
2. The government agencies should describe and identify USAs so
that the data will not be subject to various interpretations and will
be applied consistently.
3. USAs should be subject to a systematic review process since USAs
may change through time as species migrate, change location, or for
other reasons. The USA definition should be explicit and practical in
application.
4. The USA definition should be pilot tested, complete, and fully
defined before OPS uses the definition in rulemaking. Each part of the
USA definition should be pilot tested for validity, practicability, and
workability.
5. Sources of USA data should be readily available to the public
and uniform in criteria and standards.
6. Data quality objectives should include consistency, accuracy,
and extent of coverage.
7. The extent of how much additional geographic area a criterion
adds should be considered.
8. Risk elements mandated in 49 U.S.C. Sec. 60109 to NOAA's
Guidance for Facility and Vessel Response Plans (59 FR 14714; March 29,
1994) should be applied when determining USAs.
9. OPS should exempt operators that take proactive measures to
minimize the potential for spills from additional requirements to
protect USAs.
[[Page 344]]
10. Consultation with land or resource managers may be necessary
when operators consider a range of preventative measures in significant
environmental resource areas.
11. The process should clarify how sensitive areas are protected
under the Pipeline Safety Act of 1992 separate and apart from
protection under the Oil Pollution Act of 1990.
Several recommendations were made that RSPA has determined are
acceptable but are not guiding principles. These are:
1. Workshops for each phase of developing a USA definition should
include appropriate technical experts, representatives, and field
personnel with appropriate experience from agencies as well as
industry.
2. Public workshops should be used to gather information on the
criteria that will determine USAs. The USA definition should be
complete before its use in a rulemaking. The implementation of resource
assessment and protection under the USA definition could be phased.
3. All terms used in the USA definition should be defined.
4. National consistency in interpreting all definitions should be
the goal.
The following are the additional workshops that were recommended
during the October 17 workshop:
1. Guiding Principles Workshop.
2. Definitions of Terms Workshop.
3. Source Water Supply Workshop (Surface and Subsurface).
4. Biological Resources Workshop.
5. Cultural Resources and Indian Tribal Concerns Workshop.
6. Pilot Testing Process Workshop.
Persons interested in receiving a transcript of the first workshop
or the summary of the second workshop, material presented at the first
or second workshop, or comments submitted on the material presented in
the first or second public workshop notice should contact the Dockets
Unit at (202) 366-5046 and reference docket PS-140(b).
Issued in Washington, DC, on December 28, 1995.
Cesar DeLeon,
Deputy Associate Administrator for Pipeline Safety.
[FR Doc. 96-107 Filed 1-3-96; 8:45 am]
BILLING CODE 4910-60-P
Complete official Federal Register PDF
FR Doc. 95-31581 Definition of Foreign Base Company Income and Foreign Personal Holding Company Income of a Controlled Foreign Corporation; Hearing Cancellation
[Federal Register Volume 61, Number 3 (Thursday, January 4, 1996)]
[Proposed Rules]
[Pages 337-338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31581]
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[[Page 338]]
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[IL-0075-92]
RIN 1545-AR31
Definition of Foreign Base Company Income and Foreign Personal
Holding Company Income of a Controlled Foreign Corporation; Hearing
Cancellation
AGENCY: Internal Revenue Service, Treasury.
ACTION: Cancellation of notice of public hearing on proposed
regulations.
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SUMMARY: This document provides notice of cancellation of a public
hearing on proposed regulations relating to the definition of subpart F
income and foreign personal holding company income of a controlled
foreign corporation and the allocation of deficits for purposes of
computing the deemed-paid foreign tax credit.
DATES: The public hearing originally scheduled for Thursday, January 4,
1996, beginning at 10 a.m. is cancelled.
FOR FURTHER INFORMATION CONTACT:
Mike Slaughter of the Regulations Unit, Assistant Chief Counsel
(Corporate), (202) 622-7190, (not a toll-free number).
SUPPLEMENTARY INFORMATION: The subject of the public hearing is
proposed regulations under sections 952, 954(c) and 960 of the Internal
Revenue Code. A notice of proposed rulemaking and notice of public
hearing appearing in the Federal Register for Thursday, September 7,
1995 (60 FR 46548), announced that the public hearing on proposed
regulations under sections 952, 954(c) and 960 of the Internal Revenue
Code would be held on Thursday, January 4, 1996, beginning at 10 a.m.,
in the IRS Auditorium, Internal Revenue Building, 1111 Constitution
Avenue, NW., Washington, D.C.
The public hearing scheduled for Thursday, January 4, 1996, is
cancelled.
Cynthia E. Grigsby,
Chief, Regulations Unit, Assistant Chief Counsel (Corporate).
[FR Doc. 95-31581 Filed 12-29-95; 11:24 am]
BILLING CODE 4830-01-M
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