[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Page 56358]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21922]



[[Page 56357]]

Vol. 80

Thursday,

No. 180

September 17, 2015

Part IV





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 117





 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; Final Rule

  Federal Register / Vol. 80 , No. 180 / Thursday, September 17, 2015 / 
Rules and Regulations  

[[Page 56358]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

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


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a document entitled ``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 RA). 
The purpose of the RA is to provide a science-based risk analysis of 
those activity/food combinations that would be considered low risk when 
conducted in a food facility co-located on a farm. We conducted this 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.

DATES: September 17, 2015.

ADDRESSES: See the SUPPLEMENTARY INFORMATION section for electronic 
access to the RA.

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 
announced the availability of a draft qualitative risk assessment (RA) 
(Ref. 1) related to manufacturing, processing, packing, and holding 
activities for human food when such activities are conducted in a food 
facility co-located on a farm. We reopened the comment period on March 
13, 2013 (78 FR 15894) and also extended the comment period on April 
26, 2013 (78 FR 24693). We gave interested parties an opportunity to 
submit comments by September 16, 2013, for us to consider on the 
approach used, the assumptions made, the modeling techniques, the data 
used, and the clarity and the transparency of the RA documentation. We 
received more than two dozen comments on the draft RA and have revised 
it where appropriate (Refs. 2 and 3).
    The purpose of the RA is to provide a science-based risk analysis 
of those activity/food combinations that would be considered low risk 
when conducted in a food facility co-located on a farm. We conducted 
this RA to satisfy FSMA's requirements to conduct a science-based risk 
analysis and to consider the results of that analysis in determining 
whether to exempt small or very small businesses that are engaged only 
in specific types of on-farm manufacturing, processing, packing, or 
holding activities involving specific foods that we determine to be low 
risk from requirements specified in sections 418 and 421 of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350g and 21 
U.S.C. 350j, respectively), or whether to modify such requirements for 
such facilities. See 78 FR 3824 at 3825 to 3826 for additional 
background information on FSMA, the requirements of sections 418 and 
421 of the FD&C Act, the focus of the RA, the approach used, the nine 
specific questions addressed by the RA, and our request for comments.
    Before making the draft RA available for public comment, we 
submitted an earlier version of the draft RA to a group of scientific 
experts external to FDA for peer review and revised that earlier 
version, as appropriate, considering the experts' comments. A report 
concerning the external peer review is available for public review and 
can be accessed from our Web site (Ref. 4).
    Elsewhere in this issue of the Federal Register, FDA is issuing a 
final rule to implement section 418 of the FD&C Act for human food. 
That final rule establishes requirements for certain food facilities to 
conduct a hazard analysis and to identify and implement risk-based 
preventive controls. In that final rule, we use the results of the RA 
to exempt food facilities that are small or very small businesses, co-
located on a farm, from these requirements when such facilities are 
engaged only in specific types of on-farm manufacturing, processing, 
packing, or holding activities identified in the RA as low-risk 
activity/food combinations.

II. Electronic Access

    The RA and our response to comments on the draft RA are available 
electronically at http://www.regulations.gov, http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm, and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.

III. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov.

    1. FDA, ``Draft Qualitative Risk Assessment. Risk of Activity/
Food Combinations for Activities (Outside the Farm Definition) 
Conducted in a Facility Co-Located on a Farm,'' 2012. Available at: 
http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. See 
Reference 1 to the notice of availability of the draft risk 
assessment.
    2. FDA, ``Qualitative Risk Assessment. Risk of Activity/Food 
Combinations for Activities (Outside the Farm Definition) Conducted 
in a Facility Co-Located on a Farm,'' 2015. Available at: http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.
    3. FDA, ``Qualitative Risk Assessment. Risk of Activity/Food 
Combinations for Activities (Outside the Farm Definition) Conducted 
in a Facility Co-Located on a Farm. Response to Public Comments,'' 
2015. Available at: http://www.fda.gov/Food/FoodScienceResearch/RiskSafetyAssessment/default.htm and http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.
    4. FDA, ``Peer Review Report. External Peer Review of the FDA/
CFSAN Draft Qualitative Risk Assessment: Risk of Activity/Food 
Combinations for Activities (Outside the Farm Definition) Conducted 
in a Facility Co-Located on a Farm,'' 2012. Available at: http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm. See 
Reference 3 to the notice of availability of the draft risk 
assessment.

    Dated: August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21922 Filed 9-10-15; 8:45 am]
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