[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Page 56360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21923]



[[Page 56359]]

Vol. 80

Thursday,

No. 180

September 17, 2015

Part V





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Part 507





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; Final Rule

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

[[Page 56360]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 507

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


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

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: Risk 
of Activity/Animal 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/animal food combinations that would be considered low 
risk when conducted in an animal 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: Mary J. Bartholomew, Center for 
Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-402-6224.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 29, 2013 (78 FR 64428), we 
announced the availability of a draft qualitative risk assessment (RA) 
(Ref. 1) related to manufacturing, processing, packing, and holding 
activities for animal food when such activities are conducted in an 
animal food facility co-located on a farm. Interested parties were 
given the opportunity to submit comments by February 26, 2014, for us 
to consider on the approach used, the assumptions made, how risk was 
determined, the data used, and the clarity and the transparency of the 
RA documentation. We extended the comment period on February 3, 2014 
(79 FR 6116), to March 31, 2014. We received 11 comments on the draft 
RA and have revised it where appropriate (Ref. 2).
    The purpose of the RA is to provide a science-based risk analysis 
of those activity/animal food combinations that would be considered low 
risk when conducted in an animal 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 animal food 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 350j, respectively), or whether to modify such 
requirements for such facilities. See 78 FR 64428 through 64429 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. 3).
    Elsewhere in this issue of the Federal Register, FDA is issuing a 
final rule to implement section 418 of the FD&C Act for food for 
animals. That final rule establishes current good manufacturing 
practice requirements for animal food facilities and establishes 
requirements for certain animal 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 animal 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/animal 
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/downloads/AnimalVeterinary/Products/AnimalFoodFeeds/UCM366906.pdf, and 
http://www.fda.gov/downloads/Food/FoodScienceResearch/UCM459595.pdf.

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/
Animal Food Combinations for Activities (Outside the Farm 
Definition) Conducted in a Facility Co-Located on a Farm,'' 2012. 
Available at http://www.fda.gov/downloads/AnimalVeterinary/Products/AnimalFoodFeeds/UCM366906.pdf.
    2. FDA, ``Qualitative Risk Assessment. Risk of Activity/Animal 
Food Combinations for Activities (Outside the Farm Definition) 
Conducted in a Facility Co-Located on a Farm,'' 2015. Available at 
http://www.fda.gov/downloads/AnimalVeterinary/Products/AnimalFoodFeeds/UCM459595.pdf.
    3. FDA, ``Peer Review Report. External Peer Review of the FDA/
CVM Draft Qualitative Risk Assessment: Risk of Activity/Animal Food 
Combinations for Activities (Outside the Farm Definition) Conducted 
in a Facility Co-Located on a Farm,'' 2013. Available at http://www.fda.gov/ScienceResearch/SpecialTopics/PeerReviewofScientificInformationandAssessments/ucm079120.htm.


    Dated: August 31, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-21923 Filed 9-10-15; 8:45 am]
BILLING CODE 4164-01-P