[Federal Register Volume 71, Number 98 (Monday, May 22, 2006)]
[Rules and Regulations]
[Pages 29248-29250]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-4703]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 101

[Docket No. 2004P-0512]


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

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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) by adding barley as an 
additional source of beta-glucan soluble fiber eligible for the health 
claim. FDA is taking this action to complete the rulemaking initiated 
with the interim final rule.

DATES: This rule is effective May 22, 2006. The Director of the Office 
of the Federal Register approved the incorporation by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of certain 
publications in 21 CFR 101.81(c)(2)(ii)(A)(5) as of December 23, 2005.

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 December 23, 2005 (70 FR 76150), FDA 
published an interim final rule to amend the regulation that authorizes 
a health claim on the relationship between soluble fiber from certain 
foods and CHD risk (Sec.  101.81 (21 CFR 101.81)) to include beta-
glucan soluble fiber from barley. Under sections 403(r)(3)(B)(i) and 
(r)(7) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 
343(r)(3)(B)(i) and (r)(7)), FDA issued this interim final rule in 
response to a petition filed under section 403(r)(4) of the act. 
Section 403(r)(3)(B)(i) of the act states that the Secretary of Health 
and Human Services (and, by delegation, FDA) shall issue a regulation 
authorizing a health claim only if FDA ``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 21 CFR 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. Section 403(r)(7) of the 
act permits FDA to make proposed regulations issued under section 
403(r) effective upon publication pending consideration of public 
comment and publication of a final regulation if the agency determines 
that such action is necessary for public health reasons (70 FR 76150 at 
76157).
    On August 3, 2004, the National Barley Foods Council (petitioner), 
submitted a health claim petition to FDA requesting that the agency 
amend the ``Soluble fiber from certain foods and coronary heart disease 
health claim'' at Sec.  101.81 to include barley and barley products as 
an additional source of beta-glucan soluble fiber eligible for the 
health claim. FDA filed the petition for comprehensive review in 
accordance with section 403(r)(4) of the act on November 10, 2004. The 
petitioner requested that FDA grant an interim final rule by which 
labeling of barley-containing foods could bear the health claim prior 
to publication of a final rule.
    FDA considered the scientific evidence presented in the petition as 
part of its review of the scientific literature on barley beta-glucan 
soluble fiber and CHD risk, as well as information previously 
considered by the agency on the relationship of consumption of beta-
glucan containing oat foods and blood (serum or plasma) cholesterol 
levels. The agency summarized this evidence in the interim final rule 
(70 FR 76150 at 76153--76155). Based on the available evidence, FDA 
concluded that consuming whole grain barley and dry milled barley 
products that provide at least 3 grams of beta-glucan soluble fiber per 
day, is effective in lowering blood total and LDL cholesterol; and that 
the cholesterol-lowering effects of beta-glucan soluble fiber in dry 
milled barley products is comparable to that of the oat sources of 
beta-soluble glucan fiber now listed in Sec.  101.81(c)(2)(ii)(A). 
Consequently, FDA amended Sec.  101.81 to broaden the health claim to 
include whole grain barley and dry milled barley products as an 
additional source of 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 comment 
period closed on March 8, 2006. The agency received no comments related 
to the requirements in the interim final rule. Therefore, FDA is 
adopting, without change, as a final rule, the interim final rule that 
amended Sec.  101.81 to include dry milled barley products as an 
eligible source of beta-glucan soluble fiber for the soluble fiber from 
certain foods and CHD health claim.

III. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and 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). The costs and benefits 
of available regulatory alternatives analyzed in the interim final rule 
(70 FR 76150) are adopted without change in this final rule. By now 
reaffirming that interim final rule, FDA has not imposed any new 
requirements. Therefore, there are no additional costs and benefits 
associated with this final rule.

A. 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 agencies 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.

B. Unfunded Mandates

    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (2 
U.S.C. 1501 et seq., 1532) requires that agencies prepare a written 
statement, of anticipated costs and benefits before proposing any 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). This 
final rule does not create such a mandate. The current threshold after 
adjustment for inflation is $115 million, using the most current (2003) 
Implicit Price Deflator for the Gross Domestic Product. FDA does not 
expect this final rule to result in any 1-year expenditure that would 
meet or exceed this amount.

IV. Environmental Impact

    FDA 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

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environmental assessment nor an environmental impact statement is 
required.

V. Paperwork Reduction Act

    FDA has concluded 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 consumption of 
barley beta-glucan soluble fiber and CHD risk is a ``public disclosure 
of information originally supplied by the Federal Government to the 
recipient for the purpose of disclosure to the public'' (see 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 
will have a pre-emptive 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, or 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 pre-emption provision. Section 403A (a) (5) of the act (21 
U.S.C. 343-1(a)(5)) 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-- 
* * * (5) any requirement respecting any claim of the type described in 
section 403(r)(1) made in the label or labeling of food that is not 
identical to the requirement of section 403(r). * * *
    Currently, this provision operates to pre-empt States from imposing 
health claim labeling requirements concerning barley beta-glucan 
soluble fiber and reduced risk of CHD. On December 23, 2005, FDA 
published an interim final rule which imposed requirements under 
section 403(r) of the act. This final rule affirms the December 23, 
2005, amendment of food labeling regulations to add whole grain barley 
and dry milled barley products as eligible sources of beta-glucan fiber 
to the soluble fiber from certain foods and CHD health claim. Although 
this rule has a pre-emptive effect, in that it would preclude States 
from issuing any health claim labeling requirements for barley and 
reduced risk of CHD that are not identical to those required by this 
final rule, this pre-emptive effect is consistent with what Congress 
set forth in section 403A of the act. 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).
    FDA believes that the pre-emptive effect of the final rule is 
consistent with Executive order 13132. 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.'' FDA 
provided the States with an opportunity for appropriate participation 
in this rulemaking when it sought input from all stakeholders through 
publication of the interim final rule in the Federal Register on 
December 23, 2005. FDA received no comments from any States on the 
interim rulemaking.
    In addition, on January 13, 2006, FDA's Division of Federal and 
State Relations provided notice via fax and e-mail transmission to 
State health commissioners, State agriculture commissioners, food 
program directors, and drug program directors as well as FDA field 
personnel, of FDA's intended amendment to add barley beta-glucan 
soluble fiber to the soluble fiber from certain foods and CHD health 
claim (Sec.  101.81). The notice provided the States with further 
opportunity for input on the rule. It advised the States of the 
publication of the interim final rule and encouraged State and local 
governments to review the notice and to provide any comments to the 
docket (Docket No. 2004P-0512), opened in the December 23, 2005 Federal 
Register notice, by the close of the comment period indicated in the 
Federal Register notice (i.e., by March 8, 2006), or to contact certain 
named individuals. FDA received no comments in response to this notice. 
The notice has been filed in the above numbered docket.
    In conclusion, the agency believes that it has complied with all of 
the applicable requirements under the Executive order and has 
determined that the pre-emptive effects of this rule are consistent 
with Executive Order 13132.

List of Subjects in 21 CFR Part 101

    Food labeling, Incorporation by Reference, Nutrition, Reporting and 
recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
101 is amended as follows:

PART 101--FOOD LABELING

0
Accordingly, the interim final rule amending 21 CFR part 101 which was 
published at 70 FR 76150 on December 23, 2005, is adopted as a final 
rule without change.

    Dated: May 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 06-4703 Filed 5-19-06; 8:45 am]
BILLING CODE 4160-01-S