[Federal Register Volume 68, Number 144 (Monday, July 28, 2003)]
[Rules and Regulations]
[Pages 44207-44209]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19027]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 2001Q-0313]
Food Labeling: Health Claims; Soluble Dietary Fiber From Certain
Foods and Coronary Heart Disease
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is adopting as a final
rule, without change, the provisions of the interim final rule that
amended the regulation authorizing a health claim on the relationship
between beta-glucan soluble fiber from whole oat sources and reduced
risk of coronary heart disease (CHD). FDA is taking this action to
complete the rulemaking initiated with the interim final rule.
DATES: This rule is effective July 28, 2003.
FOR FURTHER INFORMATION CONTACT: James E. Hoadley, Center for Food
Safety and Applied Nutrition (HFS-830), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 301-436-1450.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 2, 2002 (67 FR 61773), the
agency published an interim final rule to amend the regulation in part
101 (21 CFR part 101) that authorizes a health claim on the
relationship between soluble dietary fiber from certain foods and
reduced risk of CHD, to include an additional eligible source of whole
oat beta-glucan soluble fiber, oatrim, the soluble fraction of alpha-
amylase hydrolyzed oat bran or whole oat flour. Under section
403(r)(3)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 343(r)(3)(B)(i)), FDA issued this interim final rule in
response to a petition filed under section 403(r)(4) of the act (21
U.S.C. 343(r)(4)). Section 403(r)(3)(B)(i) of the act states that the
Secretary of Health and Human Services (the Secretary) (and, by
delegation, FDA) shall issue a regulation authorizing a health claim
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 (see also Sec. 101.14(c)). Section
403(r)(4) of the act sets out the procedures that FDA is to follow upon
receiving a health claim petition.
On April 21, 2001, the Quaker Oats Co. and Rhodia, Inc., (the
petitioners) jointly filed a petition requesting that the agency amend
the ``soluble fiber from certain foods and coronary heart disease
health claim'' at Sec. 101.81 to include a fourth source of beta-
glucan soluble fiber eligible for the health claim. The petitioners
requested that this amendment be made ``with specific reference to the
Quaker-Rhodia group oatrim, known as Oatrim (BETATRIM)'' (Ref. 1). FDA
filed the petition for comprehensive review in accordance with section
403(r)(4) of the act on July 20, 2001.
FDA considered the relevant scientific evidence presented in the
petition as part of its review of the scientific literature on soluble
fiber from the soluble fraction of alpha-amylase hydrolyzed oat bran or
whole oat flour (referred to as ``oatrim'') and CHD risk. The agency
summarized this evidence in the interim final rule and determined that
based on the available evidence: (1) CHD continues to be a disease for
which the U.S. population is at risk; (2) soluble fiber from oatrim
when used at levels providing 0.75 grams of beta-glucan soluble fiber
per serving is a food because it provides nutritive value; (3) oatrim
when used at levels necessary to justify the health claim is safe and
lawful; (4) there is a physiological equivalence of beta-glucan soluble
fiber from oatrim and beta-glucan soluble fiber from whole oat sources
such as oat bran and rolled oats; and (5) there is significant
scientific agreement, among qualified experts, that oatrim with a beta-
glucan content of up to 10 percent on a dry weight basis (dwb) and not
less than that of the starting material (dwb) may reduce the risk of
CHD (67 FR 61773 at 61775 to 61779). Consequently, FDA published an
interim final rule amending the health claim on the relationship
between soluble dietary fiber from certain foods and reduced risk of
CHD (Sec. 101.81) to include oatrim, the soluble fraction of alpha-
amylase hydrolyzed oat bran or whole oat flour with a beta-glucan
soluble fiber content of up to 10 percent on a dwb and not less than
that of the starting material (dwb) as a source of oat beta-glucan
soluble fiber eligible for the health claim.
II. Summary of Comments and the Agency's Response
FDA solicited comments on the interim final rule. The 75-day
comment period closed on December 16, 2002. The agency received no
comments in response to the interim final rule. Given the absence of
contrary evidence on the agency's decisions announced in the interim
final rule, FDA is adopting as a final rule, without change, the
interim final rule that amended Sec. 101.81 to add oatrim, the soluble
fraction of alpha-amylase hydrolyzed oat bran or whole oat flour with a
beta-glucan soluble fiber content of up to 10 percent on a dwb and not
less than that of the starting material (dwb) as a substance eligible
for the health claim.
III. Environmental Impact
The agency has determined under 21 CFR 25.32(p) 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
[[Page 44208]]
nor an environmental impact statement is required.
IV. Analysis of Impacts
A. Regulatory Impact Analysis
We have examined the economic implications of this final rule as
required by Executive Order 12866, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4). 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).
With this final rule, FDA is adopting, without change, the
provisions of the interim final rule published in the Federal Register
of October 2, 2002. The interim final rule amended the regulation
authorizing a health claim on the relationship between beta-glucan
soluble fiber from whole oat sources and reduced risk of CHD to include
oatrim, the soluble fraction of alpha-amylase hydrolyzed oat bran or
whole oat flour with a beta-glucan content up to 10 percent dwb and not
less than that of the starting material (dwb). We assessed the costs
and benefits of the interim final rule in that Federal Register
document (67 FR 61773 at 61781). By now reaffirming that interim final
rule, FDA has not imposed any new requirements. There are, therefore,
no additional costs and benefits associated with this final rule.
B. Regulatory Flexibility Analysis
We have examined the economic implications of this final rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires the agency to analyze
regulatory options that would minimize the economic impact of the rule
on small entities.
As this final rule does not make any changes to the interim final
rule or our analysis included therein, this final rule does not impose
any new costs on firms. Accordingly, we certify that this final rule
will not have a significant economic impact on a substantial number of
small entities. Therefore, under the Regulatory Flexibility Act, no
further analysis is required.
C. Unfunded Mandates
Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Public
Law 104-4) requires that agencies prepare a written statement of
anticipated costs and benefits before issuing any final rule that may
result in an expenditure by State, local, and tribal governments, in
the aggregate, or by the private sector, of $100,000,000 in any one
year (adjusted annually for inflation). The Unfunded Mandates Reform
Act does not require FDA to prepare a statement of costs and benefits
for this rule, because the rule is not expected to result in any 1 year
expenditure that would exceed $100 million adjusted for inflation. The
current inflation-adjusted statutory threshold is $113 million.
V. Paperwork Reduction Act
FDA concludes that the labeling provisions of this final rule are
not subject to review by the Office of Management and Budget because
they do not constitute a ``collection of information'' under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather, the food
labeling health claim on the association between oatrim and reduced
risk of CHD is a ``public disclosure of information originally supplied
by the Federal Government to the recipient for the purpose of
disclosure to the public'' (5 CFR 1320.3(c)(2)).
VI. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
has a preemptive effect on State law. Section 4(a) of the Executive
order requires agencies to ``construe * * * a Federal Statute to
preempt State law only where the statute contains an express preemption
provision, there is some other clear evidence that the Congress
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute.'' Section 403A of the act (21 U.S.C. 343-1) is an
express preemption provision. That section provides that ``no State or
political subdivision of a State may directly or indirectly establish
under any authority or continue in effect as to any food in interstate
commerce'' certain food labeling requirements, unless an exemption is
provided by the Secretary (and by delegation, FDA). Relevant to this
final rule, one such requirement that states and political subdivisions
may not adopt is ``any requirement respecting any claim of the type
described in section 403(r)(1) of the act made in the label or labeling
of food that is not identical to the requirement of section 403(r) * *
*'' (section 403A(a)(5) of the act (21 U.S.C. 343-1(a)(5)). Prior to
the effective date of this rule and the interim final rule that
preceded it, this provision operated to preempt States from imposing
health claim labeling requirements concerning beta glucan soluble fiber
from oatrim and reduced risk of CHD because no such requirements had
been imposed by FDA under section 403(r) of the act. Under this final
rule and the interim final rule that preceded it, States are preempted
from imposing any health claim labeling requirements for beta-glucan
soluble fiber from oatrim and reduced risk of CHD that are not
identical to those required by these rules. Section 403A(a)(5) of the
act displaces both state legislative requirements and state common-law
duties. Medtronic v. Lohr, 518 U.S. 470, 503 (1996) (Breyer, J.,
concurring in part and concurring in judgment); id. at 510 (O'Connor,
J., joined by Rehnquist, C.J., Scalia, J., and Thomas, J., concurring
in part and dissenting in part); Cipollone v. Liggett Group, Inc., 505
U.S. 504, 521 (1992) (plurality opinion); id. at 548-49 (Scalia, J.,
joined by Thomas, J., concurring in judgment in part and dissenting in
part). Although this final rule has preemptive effect in that it would
preclude States from adopting statues, issuing regulations or adopting
or enforcing any requirements including state tort-law requirements,
about beta-glucan soluble fiber from oatrim and reduced risk of CHD
that are not identical to the provisions of the interim final rule as
adopted by this final rule, this preemptive effect is consistent with
what Congress set forth in section 403A of the act.
Section 4(e) of the Executive order provides that ``when an agency
proposes to act through adjudication or rulemaking to preempt State
law, the agency shall provide all affected State and local officials
notice and an opportunity for appropriate participation in the
proceedings.'' Similarly, section 6(e) of the Executive order states
that ``to the extent practicable and permitted by law, no agency shall
promulgate any regulation that has federalism implications and that
preempts state law, unless the agency, prior to the formal promulgation
of the regulation *** consulted with State and local officials early in
the process of developing the proposed regulation.'' This requirement,
that FDA provide the States with an opportunity for appropriate
participation in this rulemaking, has been met. FDA sought input from
all stakeholders through publication of the interim final rule in the
Federal Register. There were no
[[Page 44209]]
comments from State or local government entities received.
In conclusion, the agency believes that it has complied with all of
the applicable requirements under the Executive order and has
determined that the preemptive effects of this final rule are
consistent with Executive Order 13132.
VII. References
The following reference has been placed on display at the Division
of Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
1. The Quaker Oats Co. and Rhodia, Inc., ``Oatrim (BETATRIM) Health
Claim Petition,'' HCN1, vol. 1, Docket No. 01Q-0313, April 12, 2001.
0
Accordingly, the interim final rule amending 21 CFR 101.81 that was
published in the Federal Register of October 2, 2002 (67 FR 61773), is
adopted as a final rule without change.
Dated: July 21, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-19027 Filed 7-25-03; 8:45 am]
BILLING CODE 4160-01-S