
[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Proposed Rules]
[Pages 24693-24694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09762]


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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; Extension of the 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 that we made available for public comment 
by notification in the Federal Register of January 16, 2013. We are 
taking this action to make the comment period for the draft RA conform 
to the comment period for proposed rules entitled ``Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food'' (the proposed preventive controls rule) and 
``Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption'' (the proposed produce safety rule). 
Elsewhere in this issue of the Federal Register, we are announcing a 
120-day extension of the comment period for the proposed preventive 
controls rule and the proposed produce safety rule.

DATES: The comment period for the document published January 16, 2013, 
at 78 FR 3824, reopened March 13, 2013, at 78 FR 15894, is extended. 
Submit either electronic or written comments by September 16, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to 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. Interested persons were originally given 
until February 15, 2013, to comment on the draft RA.
    We conducted this draft RA to satisfy requirements of the FDA Food 
Safety Modernization Act (FSMA) (Pub. L. 111-353) 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 3824), 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 on-farm 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 May 16, 2013, to comment on the proposed 
preventive controls rule.
    We previously received requests to allow interested persons 
additional time to comment on the draft RA. Two requesters had 
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 the proposed produce safety rule, which published in the 
Federal Register of January 16, 2013 (78 FR 3504), and other major 
rulemakings that we would be conducting under FSMA but were not yet 
published.) We considered the requests and reopened the comment period 
for the draft RA until May 16, 2013--i.e., the same date as that for 
the proposed preventive controls rule and the proposed produce safety 
rule (Federal Register of March 13, 2013, 78 FR 15894).
    We have now received comments requesting an extension of the 
comment period on the proposed preventive controls rule and the 
proposed produce safety rule. Each request conveyed concern that the 
current 120-day comment period does not allow sufficient time to 
develop a meaningful or thoughtful response to those proposed rules. We 
have considered the requests and, elsewhere in this issue of the 
Federal Register, we are granting a 120-day extension of the comment 
period for those proposed rules. We are extending the comment period 
for the draft RA for 120 days to continue to make the comment period 
for the draft RA conform to the comment period for the proposed 
preventive controls rule and the proposed produce safety rule.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
the draft RA 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.


[[Page 24694]]


    Dated: April 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09762 Filed 4-24-13; 11:15 am]
BILLING CODE 4160-01-P


