Document ID: FDA-2013-N-1043-0002
Agency: fda
Document Type: Proposed Rule
Title: Draft Qualitative Risk Assessment of Risk of Activity/Animal Food
Combinations for Activities (Outside the Farm Definition) Conducted in a
Facility Co-Located on a Farm; Availability; Extension of Comment Period
Posted Date: 2014-02-03T05:00Z

[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Proposed Rules]
[Pages 6116-6117]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02112]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 507

[Docket No. FDA-2013-N-1043]

Draft Qualitative Risk Assessment of Risk of Activity/Animal Food 
Combinations for Activities (Outside the Farm Definition) Conducted in 
a Facility Co-Located on a Farm; Availability; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for a document we made available for public comment in 
the Federal Register of October 29, 2013 (78 FR 64428) (the draft RA). 
We are taking this action to make the comment period for the draft RA 
conform to the comment period for proposed rule entitled ``Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Food for Animals'' (the proposed preventive controls rule 
for food for animals).

DATES: FDA is extending the comment period on the draft RA. Submit 
either electronic or written comments by March 31, 2014.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-1043 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
    Mail/Hand delivery/Courier (for paper submissions): Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and Docket No. FDA-2013-N-1043. All comments received may be posted 
without change to http://www.regulations.gov, including any personal 
information provided. For additional information on submitting 
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY 
INFORMATION.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov, and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kim Young, Center for Veterinary 
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, 
MD 20855, 240-276-2207.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 29, 2013, we published a 
notification with a 120-day comment period announcing the availability 
of, and requesting comment on, a document entitled ``Draft Qualitative 
Risk Assessment of Risk of Activity/Animal Food Combinations for 
Activities (Outside the Farm Definition) Conducted in a Facility Co-
Located on a Farm'' (the draft RA). The purpose of the draft RA is to 
provide a science-based risk analysis of those activity/animal food 
combinations that would be considered low risk.
    We conducted this draft RA to satisfy requirements of the FDA Food 
Safety Modernization Act (FSMA) to conduct a science-based risk 
analysis and to consider the results of that analysis in rulemaking 
that is required by FSMA.
    In the Federal Register of October 29, 2013, we announced that we 
had used the results of the draft RA to propose to exempt certain 
animal food facilities (i.e., those that are small or very small 
businesses that are engaged only in specific types of on-farm 
manufacturing, processing, packing, or holding activities identified in 
the draft RA as low-risk activity/animal food combinations) from the 
proposed requirements of the Federal Food, Drug, and Cosmetic Act for 
hazard analysis and risk-based preventive controls (the proposed 
preventive controls rule). Interested persons were originally given 
until February 26, 2014, to comment on the proposed preventive controls 
rule.
    FDA has received requests for an extension of the comment period on 
the proposed preventive controls rule for

[[Page 6117]]

food for animals to allow interested persons an opportunity to consider 
the interrelationship between this proposed rule and the proposed rules 
entitled ``Foreign Supplier Verification Programs for Importers of Food 
for Humans and Animals'' (78 FR 45729, July 29, 2013) and 
``Accreditation of Third-Party Auditors/Certification Bodies to Conduct 
Food Safety Audits and to Issue Certifications'' (78 FR 45782, July 29, 
2013). We have considered the requests, and elsewhere in this issue of 
the Federal Register, we are granting an extension of the comment 
period to March 31, 2014, for the proposed preventive controls rule. We 
are extending the comment period for the draft RA to March 31, 2014, to 
continue to make the comment period for the draft RA conform to the 
comment period for the proposed preventive controls rule.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
the proposed rule to http://www.regulations.gov or written comments to 
the Division of Dockets Management (see ADDRESSES). It is only 
necessary to send one set of comments. Identify comments 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, and will be posted to 
the docket at http://www.regulations.gov.

    Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02112 Filed 1-31-14; 8:45 am]
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