[Federal Register Volume 68, Number 144 (Monday, July 28, 2003)]
[Rules and Regulations]
[Pages 44207-44209]
From the Federal Register Online via the Government Printing 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