47828 Federal Register / Vol. 73, No. 159 / Friday, August 15, 2008 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 101 

[Docket No. FDA–2008–P–0090] (formerly 

Docket No. 2006P–0393) 

Food Labeling: Health Claims; Soluble 

Fiber From Certain Foods and Risk of 

Coronary Heart Disease 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is adopting as a 

final rule, without change, the 

provisions of the interim final rule (IFR) 

that amended the regulation authorizing 

a health claim on soluble fiber from 

certain foods and risk of coronary heart 

disease (CHD), to add barley betafiber as 

an additional eligible source of betaglucan soluble fiber. FDA is taking this 

action to complete the rulemaking 

initiated with the IFR. 

DATES: This final rule is effective August 

15, 2008. 

FOR FURTHER INFORMATION CONTACT: 

Jillonne Kevala, 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 February 

25, 2008 (73 FR 9938), FDA published 

an IFR to amend the regulation in part 

101 (21 CFR part 101) that authorizes a 

health claim on the relationship 

between soluble fiber from certain foods 

and CHD (§ 101.81), to include barley 

betafiber as an additional eligible source 

of beta-glucan soluble fiber. Under 

section 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 

343(r)(7)), FDA issued the IFR in 

response to a petition filed under 

section 403(r)(4) of the act. On June 20, 

2006, Cargill Inc. (the petitioner), 

submitted a health claim petition to 

FDA requesting that the agency expand 

the ‘‘Soluble fiber from certain foods 

and coronary heart disease’’ health 

claim (§ 101.81) to include barley 

betafiber as an eligible food ingredient 

source of beta-glucan soluble fiber. The 

petitioner requested that FDA grant an 

IFR by which foods containing barley 

betafiber could bear the health claim 

prior to publication of the final rule. 

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 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 § 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 a proposed regulation 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. FDA filed the petition 

for comprehensive review in accordance 

with section 403(r)(4) of the act on 

September 28, 2006. 

As part of its review of the scientific 

literature on barley betafiber and CHD, 

FDA considered the scientific evidence 

presented in the petition as well as 

information previously considered by 

the agency on CHD risk reduction and 

the effects of beta-glucan soluble fiber 

containing food ingredients on lowering 

serum total and low density lipoprotein 

(LDL) cholesterol. The agency 

summarized this evidence in the IFR (73 

FR 9938 at 9941 to 9943). Based on the 

available evidence, FDA concluded that 

barley betafiber, like the other whole oat 

and barley products listed in 

§ 101.81(c)(2)(ii)(A), lowers serum total 

and LDL cholesterol. Consequently, 

FDA amended § 101.81(c)(2)(ii)(A) to 

broaden the health claim to include 

barley betafiber as an additional eligible 

source of beta-glucan soluble fiber. 

II. Summary of Comments and the 

Agency’s Response 

FDA solicited comments on the IFR. 

The comment period closed on May 12, 

2008. The agency received five letters of 

response, three from consumers, one 

from academia, and one from the 

Commonwealth of Kentucky. One 

consumer comment and the comment 

from academia supported the IFR. The 

Commonwealth of Kentucky advised the 

agency that FDA’s ruling on the health 

claim would not adversely affect the 

State’s actions or conflict with any State 

laws. The remaining consumer 

comments addressed issues that are 

outside the scope of this rulemaking and 

will not be addressed here. 

Given the absence of contrary 

evidence on the agency’s decisions 

announced in the IFR, FDA is adopting 

as a final rule, without change, the IFR 

that amended § 101.81 to include barley 

betafiber as an additional eligible source 

of beta-glucan soluble fiber. 

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 agency 

believes that this final rule is not a 

significant regulatory action under the 

Executive order. 

The Regulatory Flexibility Act 

requires agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this final rule allows 

new voluntary behavior and imposes no 

additional restrictions on current 

practices, the agency certifies that the 

final rule will not have a significant 

economic impact on a substantial 

number of small entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that agencies prepare a written 

statement which includes an assessment 

of anticipated costs and benefits before 

proposing ‘‘any rule that includes any 

Federal mandate that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100,000,000 or more 

(adjusted annually for inflation) in any 

one year.’’ The current threshold after 

adjustment for inflation is $127,000,000, 

using the most current (2006) Implicit 

Price Deflator for the Gross Domestic 

Product. FDA does not expect this final 

rule to result in any one-year 

expenditure that would meet or exceed 

this amount. 

FDA received no comments relevant 

to economic impact. The costs and 

benefits of available regulatory 

alternatives analyzed in the IFR (73 FR 

9938 at 9944 and 9945) are adopted, 

without change, in this final rule. By 

now affirming that IFR, FDA has not 

imposed any new requirements. 

Therefore, there are no additional costs 

and benefits associated with this final 

rule. 


sroberts on PROD1PC70 with PROPOSALS
Federal Register / Vol. 73, No. 159 / Friday, August 15, 2008 / Rules and Regulations 47829 

IV. 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 

nor an environmental impact statement 

is required. 

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 

consumption of barley betafiber and 

reduced risk of coronary heart disease 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 will have 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 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 preemption provision. 

Section 403A(a)(5) of the act 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—* * * 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). * * *’’

On February 25, 2008, FDA published 

an IFR which imposed requirements 

under section 403(r) of the act. This 

final rule affirms the February 25, 2008, 

amendment to the existing food labeling 

regulations to add barley betafiber to the 

authorized health claim for soluble fiber 

from certain foods and CHD. Although 

this rule has a preemptive effect in that 

it precludes States from issuing any 

health claim labeling requirements for 

barley betafiber and reduced risk of 

CHD that are not identical to those 

required by this final rule, this 

preemptive 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 (Riegel v. Medtronic, 128 S. Ct. 

999 (2008)). 

FDA believes that the preemptive 

effect of this 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.’’ On 

December 12, 2007, 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 intent to amend the 

health claim regulation authorizing 

health claims for soluble fiber from 

certain foods and CHD (§ 101.81). 

In addition, the agency sought input 

from all stakeholders through 

publication of the IFR in the Federal 

Register on February 25, 2008. FDA 

received one comment from the 

Commonwealth of Kentucky, which 

noted that FDA’s ruling on the health 

claim would not adversely affect the 

State’s actions or conflict with any State 

laws. 

In conclusion, the agency believes 

that it has complied with all of the 

applicable requirements of Executive 

Order 13132 and has determined that 

the preemptive effects of this rule are 

consistent with the Executive order. 

List of Subjects in 21 CFR Part 101 

Food labeling, 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, 21 CFR part 101 is 

amended as follows: 

PART 101—FOOD LABELING 

■ Accordingly, the interim final rule 

amending § 101.81 that was published 

in the Federal Register of February 25, 

2008 (73 FR 9938), is adopted as a final 

rule, without change. 

Dated: August 7, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–18863 Filed 8–14–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF STATE 

22 CFR Part 94 

[Public Notice: 6320] 

RIN 1400–AC45 

Procedures for Children Abducted to 

the United States; Interim Final Rule 

AGENCY: Department of State. 

ACTION: Interim final rule with request 

for comments. 

SUMMARY: This interim final rule 

amends regulations regarding incoming 

parental abduction cases pursuant to the 

Hague Convention on the Civil Aspects 

of International Child Abduction. 

Incoming cases will be processed by the 

United States Central Authority (USCA), 

the Office of Children’s Issues in the 

Bureau of Consular Affairs within the 

U.S. Department of State or an entity 

designated by the USCA. 

DATES: This rule is effective August 15, 

2008. 

The Department will accept written 

comments from the public through 

September 15, 2008. 

ADDRESSES: You may submit comments, 

identified by RIN 1400–AC45, by either 

of the following methods: 

• Electronic comments: Submit 

through the Federal eRulemaking Portal; 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Address all written 

submissions to Corrin M. Ferber, CA/ 

OCS/PRI, U.S. Department of State, 

2100 Pennsylvania Ave., NW., 4th 

Floor, Washington, DC 20037, fax 202–

736–9111. 

Instructions: Please submit one copy 

of your comments by only one method. 

All submissions must include the 

agency name and Regulatory 

Information Number (RIN) identification 

above for this rulemaking. 

FOR FURTHER INFORMATION CONTACT: 

Corrin M. Ferber, CA/OCS/PRI, U.S. 

Department of State, Room 4039, 2201 

C Street, NW., Washington, DC 20520; 

telephone: (202) 736–9172 (this is not a 

toll free number). Hearing-or speechimpaired persons may use the 

Telecommunications Devices for the 

Deaf (TDD) by contacting the Federal 

Information Relay Service at 1–800–

877–8339. 


sroberts on PROD1PC70 with PROPOSALS