[Federal Register Volume 71, Number 96 (Thursday, May 18, 2006)]
[Notices]
[Pages 28872-28873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7528]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0379] (formerly Docket No. 03D-0379)


Guidance for Industry: Preparing a Claim of Categorical Exclusion 
or an Environmental Assessment for Submission to the Center for Food 
Safety and Applied Nutrition; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance for Industry: 
Preparing a Claim of Categorical Exclusion or an Environmental 
Assessment for Submission to the Center for Food Safety and Applied 
Nutrition'' (the guidance). This guidance provides information to 
industry on how to prepare a claim of categorical exclusion or an 
environmental assessment (EA) for submission to the Center for Food 
Safety and Applied Nutrition (CFSAN) in notifications for food contact 
substances, food additive petitions, color additive petitions, requests 
for exemption from regulation as a food additive, generally recognized 
as safe (GRAS) petitions, and petitions for certain food labeling 
regulations.

DATES: This guidance document is final upon the date of publication. 
Submit written or electronic comments concerning this guidance document 
at any time.

[[Page 28873]]


ADDRESSES: Submit written requests for single copies of the guidance 
document to the Office of Food Additive Safety (HFS-265), Center for 
Food Safety and Applied Nutrition, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740. Include a self-addressed 
adhesive label to assist that office in processing your request. 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.fda.gov/dockets/ecomments. To ensure a timelier processing of comments, FDA is 
no longer accepting comments submitted to the agency by e-mail. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.

FOR FURTHER INFORMATION CONTACT: Layla I. Batarseh, Center for Food 
Safety and Applied Nutrition (HFS-246), 5100 Paint Branch Pkwy., 
College Park, MD, 20740-3835, 301-436-1296, FAX 301-436-2973, or e-
mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    As an integral part of its decision-making process, FDA is 
obligated under the National Environmental Policy Act of 1969 (NEPA) to 
consider the environmental impact of its actions, including allowing 
notifications for food contact substances to become effective and 
approving food additive petitions, color additive petitions, GRAS 
affirmation petitions, requests for exemption from regulation as a food 
additive, and actions on certain food labeling citizen petitions, 
nutrient content claims petitions, and health claims petitions. In 
1997, FDA amended its regulations in 21 CFR part 25 to provide for 
categorical exclusions for additional classes of actions that do not 
individually or cumulatively have a significant effect on the human 
environment (62 FR 40570, July 29, 1997). As a result of that 
rulemaking, FDA no longer routinely requires submission of information 
about the manufacturing and production of FDA-regulated articles. FDA 
also has eliminated the previously required EA and abbreviated EA 
formats from the amended regulations. Instead, FDA is providing this 
guidance that contains sample formats to help industry submit a claim 
of categorical exclusion or an EA to CFSAN. This guidance document 
identifies, interprets, and clarifies existing requirements imposed by 
statute and regulation, consistent with the Council on Environmental 
Quality regulations (40 CFR 1507.3). It consists of recommendations 
that do not themselves create requirements; rather, they are 
explanatory guidance for FDA's own procedures in order to ensure full 
compliance with the purposes and provisions of NEPA.
    This guidance provides information to assist in the preparation of 
claims of categorical exclusion and EAs for submission to CFSAN. The 
following topics are covered in this guidance: (1) What types of 
industry-initiated actions are subject to a claim of categorical 
exclusion, (2) What must a claim of categorical exclusion include by 
regulation, (3) What is an EA, (4) When is an EA required by regulation 
and what format should be used, (5) What are extraordinary 
circumstances, and (6) What suggestions does CFSAN have for preparing 
an EA? Although CFSAN encourages industry to use the EA formats 
described in this guidance because standardized documentation submitted 
by industry increases the efficiency of the review process, alternative 
approaches may be used if these approaches satisfy the requirements of 
the applicable statutes and regulations.
    In the Federal Register of September 17, 2003 (68 FR 54462), FDA 
announced the availability of a draft guidance document entitled 
``Guidance for Industry: Preparing a Claim of Categorical Exclusion or 
an Environmental Assessment for Submission to the Center for Food 
Safety and Applied Nutrition.'' The agency solicited public comments on 
the draft guidance document. FDA did not receive any comments and is 
finalizing the draft guidance without revision, except for those 
revisions necessary to update certain contact information.
    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 document represents FDA's current thinking on 
the preparation of a claim of categorical exclusion or an EA for 
submission to CFSAN. It does not create or confer any rights for or on 
any person and does not operate to bind FDA or the public. You may use 
an alternative approach if such approach satisfies the requirements of 
the applicable statutes and regulations. If you want to discuss an 
alternative approach, contact the FDA staff responsible for 
implementing this guidance (see FOR FURTHER INFORMATION CONTACT).

II. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0541.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this guidance 
at any time. 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 brackets in the heading of this document. The guidance document and 
received comments may be seen in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance 
document at http://www.cfsan.fda.gov/guidance.html.

    Dated: May 10, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7528 Filed 5-17-06; 8:45 am]
BILLING CODE 4160-01-S