[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Proposed Rules]
[Pages 15894-15895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-05730]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2012-N-1258]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or ``we'') is reopening 
the comment period for a document entitled ``Draft Qualitative Risk 
Assessment of Risk of Activity/

[[Page 15895]]

Food Combinations for Activities (Outside the Farm Definition) 
Conducted in a Facility Co-Located on a Farm'' (the draft RA) that we 
made available for public comment in the Federal Register of January 
16, 2013. We are reopening the comment period to update comments and to 
receive any new information.

DATES: Submit either electronic or written comments by May 16, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety 
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 16, 2013 (78 FR 3824), we 
published a notification with a 30-day comment period announcing the 
availability of, and requesting comment on, a document entitled ``Draft 
Qualitative Risk Assessment of Risk of Activity/Food Combinations for 
Activities (Outside the Farm Definition) Conducted in a Facility Co-
Located on a Farm.'' The purpose of the draft RA is to provide a 
science-based risk analysis of those activity/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 January 16, 2013 (78 FR 3646), we announced that we had 
used the results of the draft RA to propose to exempt certain food 
facilities (i.e., those that are small or very small businesses that 
are engaged only in specific types of onfarm manufacturing, processing, 
packing, or holding activities identified in the draft RA as low-risk 
activity/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 15, 2013, to comment on 
the draft RA.

II. Request for Comments

    Following publication of the notification announcing the 
availability of, and requesting comment on, the draft RA, we received 
three requests to allow interested persons additional time to comment. 
The requesters asserted that the time period of 30 days was 
insufficient to respond fully to FDA's specific requests for comments 
and to allow potential respondents to thoroughly evaluate and address 
pertinent issues. Two requesters considered that the comment period for 
the draft RA should conform to the comment period of the proposed 
preventive controls rule. (One of these requesters further requested 
that the comment period conform to that of another proposed rule 
published in the Federal Register of January 16, 2013 (78 FR 3504; the 
proposed produce safety rule) and other major rulemakings that FDA 
would be conducting under FSMA but were not yet published.) For similar 
reasons, another requestor considered that the comment period should be 
extended by another 120 days, to June 14, 2013.
    We have considered the requests and are reopening the comment 
period for the draft RA until May 16, 2013, which conforms to the 
comment periods of the proposed preventive controls rule and the 
proposed produce safety rule. We believe that this extension allows 
adequate time for interested persons to submit comments without 
significantly delaying the associated rulemaking in the proposed 
preventive controls rule.

III. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
this document 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: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05730 Filed 3-12-13; 8:45 am]
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