[Federal Register: May 22, 2006 (Volume 71, Number 98)]
[Rules and Regulations]
[Page 29248-29250]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22my06-4]
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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
[[Page 29249]]
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
[[Page 29250]]
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
Interim Final Rule December 23, 2005