3058 Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Submit electronic comments to http:// 

www.regulations.gov. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/cvm or http:// 

www.regulations.gov. 

Dated: January 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–862 Filed 1–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0381] 

Guidance for Industry on Voluntary 

Third-Party Certification Programs for 

Foods and Feeds; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Voluntary Third-Party 

Certification Programs for Foods and 

Feeds.’’ This guidance describes the 

general attributes FDA believes a 

voluntary third-party certification 

program should have in order to help 

ensure its certification is a reliable 

reflection that the foods and feeds 

(hereinafter foods) from certified 

establishments meet applicable FDA 

requirements, as well as other 

certification criteria. 

DATES: Submit written or electronic 

comments on agency guidance 

documents at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Policy, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, rm. 4337, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist that 

office in processing your requests. The 

guidance can also be obtained by mail 

by calling 301–796–4840. Submit 

written comments on the guidance to 

the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Sharon Lindan Mayl, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, rm. 4337, Silver Spring, 

MD 20993–0002, 301–796–4840. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a guidance for industry entitled 

‘‘Voluntary Third-Party Certification 

Programs for Foods and Feeds.’’ This 

guidance represents FDA’s current 

thinking on the certification process and 

describes the general attributes FDA 

believes a voluntary third-party 

certification program should have in 

order to provide FDA with confidence 

in its certification program. If FDA has 

such confidence, we may choose to 

recognize the program and provide 

incentives for establishments to obtain 

certification by recognized certification 

programs. Recognition in this context 

means that FDA has determined that 

certification may be a reliable reflection 

that the foods from an establishment 

certified by that certification body meet 

applicable FDA requirements, as well as 

other certification criteria. 

This guidance is intended as one of 

the steps in FDA’s future recognition of 

one or more voluntary third-party 

certification programs for particular 

product types. In the future, FDA (we) 

may issue guidance that addresses thirdparty certification programs in 

particular product areas. 

This guidance is issued in response to 

the recommendations contained in the 

Action Plan for Import Safety: A 

Roadmap for Continual Improvement 

(Action Plan) issued on November 6, 

2007, by the Interagency Working Group 

on Import Safety (Working Group) 

established by Executive Order 13439, 

as well as FDA’s Food Protection Plan 

released on the same date. Both those 

plans emphasize certification as a way 

to improve our capacity to verify the 

safety of products from a growing food 

establishment inventory, both domestic 

and foreign. 

In the Federal Register of April 2, 

2008 (73 FR 17989), FDA issued a 

document requesting comments on the 

use of third-party certification programs 

for foods and animal feeds. FDA 

received approximately 70 comments in 

response to that document. The 

comments were generally supportive of 

the use of third-party certification 

programs. Many encouraged FDA to 

recognize such programs as a way to 

increase participation and improve the 

safety and security of foods. 

On July 10, 2008, we announced the 

availability of a draft guidance for 

industry entitled ‘‘Voluntary ThirdParty Certification Programs for Foods 

and Feeds’’ (73 FR 39704). In response 

to the draft guidance, we received 19 

comments from a variety of sources, 

including trade associations, individual 

companies, standards development 

organizations, and other domestic and 

foreign Government agencies. These 

comments were considered as the 

guidance was finalized. 

Also on July 10, 2008, FDA issued a 

document announcing a pilot on 

Voluntary Third-Party Certification 

Programs for Imported Aquacultured 

Shrimp (73 FR 39705). We are currently 

in Phase II of the pilot in which we will 

conduct onsite audits of selected thirdparty certification bodies and targeted 

sampling of imported shrimp products. 

The goal of the pilot is to gather 

technical and operational information 

that will assist FDA in determining its 

infrastructure needs, as well as the 

process for evaluating third-party 

certification programs. Based on our 

experience with the pilot, we may make 

additional changes to the guidance 

being announced in this document. 

The guidance makes several changes 

from the draft guidance. For example, 

the section on verification that the 

establishment meets certification 

criteria no longer includes detailed 

criteria on specific safety and security 

systems. Instead, the guidance only 

recommends that the audit provide the 

certification body with reasonable 

assurance that the food or feed is safe 

and in compliance with certification 

criteria, which should include FDA 

requirements. As FDA recognizes thirdparty certification programs in 

particular product areas, FDA plans to 

provide additional guidance on specific 

certification criteria for those product 

areas. 

In order to help minimize confusion, 

the guidance uses terminology that is 

generally consistent with accepted 

international definitions, such as those 

used in documents by the International 

Organization for Standardization (ISO) 

and the Codex Alimentarius 

Commission (Codex). There may be 

some divergence, however, when uses 

of the terms by these organizations are 

inconsistent or when use of the 

internationally accepted terminology 

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Federal Register / Vol. 74, No. 11 / Friday, January 16, 2009 / Notices 3059 

would not make sense in a particular 

context. 

The guidance states that a 

certification body should immediately 

notify FDA and the establishment it is 

certifying if an auditor finds or 

discovers a situation in which there is 

a reasonable probability that the food or 

feed from the audited establishment will 

cause serious adverse health 

consequences or death to humans or 

animals. We believe that such reporting 

is appropriate. Although the 

certification body is not a regulatory 

entity, we believe it would help protect 

public health for such circumstances to 

be reported to FDA so that we can 

investigate the situation. The guidance 

also notes that an establishment that 

receives this information may be subject 

to the requirement imposed by section 

1005 of the Food and Drug 

Administration Amendments Act of 

2007 to report certain information to 

FDA via an electronic portal. 

The guidance states that while FDA 

may provide incentives for 

participation, neither establishments 

nor certifying bodies are under an 

obligation to participate. FDA does not 

intend to target uncertified 

establishments or products for 

inspection or sampling, for example, 

based solely on their lack of 

certification. 

One comment raised a concern 

regarding the ability of a foreign 

Government to serve as a certification 

body. As in the draft guidance, the 

guidance states that foreign 

Governments may be certification 

bodies. More specifically, the definition 

of certification body states that it could 

be a Federal, State, local, or foreign 

Government agency, as well as a nonGovernment entity that is independent 

of the businesses it certifies and free 

from conflicts of interest. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

current thinking on voluntary thirdparty certification programs for foods 

and feeds. It does not create or confer 

any rights for or on any person and does 

not operate to bind FDA or the public. 

An alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the guidance. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified with the 

docket number found in the brackets in 

the heading of this document. A copy of 

the guidance and received comments 

are available for public examination in 

the Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS 

athttp://www.regulations.gov. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at either http:// 

www.fda.gov/oc/guidance/ 

thirdpartycert.html or http:// 

www.regulations.gov. 

Dated: January 12, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–861 Filed 1–15–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0371 (formerly 

Docket No. 2007D–0125)] 

Guidance for Industry: EvidenceBased Review System for the Scientific 

Evaluation of Health Claims 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance document 

entitled ‘‘Guidance for Industry: 

Evidence-Based Review System for the 

Scientific Evaluation of Health Claims.’’ 

This guidance outlines the agency’s 

approach to the review of the scientific 

evidence for health claims that meet the 

significant scientific agreement standard 

(SSA) and qualified health claims. 

Elsewhere in this issue of the Federal 

Register, FDA is announcing the 

withdrawal of the guidance documents 

entitled ‘‘Guidance for Industry and 

FDA: Interim Evidence-Based Ranking 

System for Scientific Data’’ and 

‘‘Guidance for Industry: Significant 

Scientific Agreement in the Review of 

Health Claims for Conventional Foods 

and Dietary Supplements.’’ 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Nutrition, Labeling, and 

Dietary Supplements, Center for Food 

Safety and Applied Nutrition, (HFS– 

830), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740. Send two self-addressed 

adhesive labels to assist that office in 

processing your requests. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the guidance to 

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

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Paula R. Trumbo, Center for Food Safety 

and Applied Nutrition (HFS–830), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1191. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of July 9, 2007 

(72 FR 37246), FDA announced the 

availability of a draft guidance entitled 

‘‘Guidance for Industry: Evidence-Based 

Review System for the Scientific 

Evaluation of Health Claims.’’ The 

agency considered received comments 

as it finalized this guidance. The 

primary purpose of this guidance is to 

provide a description of the scientific 

evaluation process that FDA uses in 

determining the strength of the 

relationship of a substance to decreasing 

the risk of a disease or health-related 

condition. 

FDA is issuing this guidance 

document as a level 1 guidance 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the agency’s 

current thinking on the evaluation of 

scientific evidence for health claims. It 

does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An alternate 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

mstockstill on PROD1PC66 with NOTICES