80 FR 56359 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 180 (September 17, 2015)

Page Range		56359-56360
FR Document		2015-21923

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.

Federal Register, Volume 80 Issue 180 (Thursday, September 17, 2015)

[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 56359-56360]
From the Federal Register Online [www.thefederalregister.org]
[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

56360 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations

DEPARTMENT OF HEALTH AND February 26, 2014, for us to consider on very small businesses, co-located on a
HUMAN SERVICES the approach used, the assumptions farm, from these requirements when
made, how risk was determined, the such facilities are engaged only in
Food and Drug Administration data used, and the clarity and the specific types of on-farm manufacturing,
transparency of the RA documentation. processing, packing, or holding
21 CFR Part 507 We extended the comment period on activities identified in the RA as low-
[Docket No. FDA–2013–N–1043]
February 3, 2014 (79 FR 6116), to March risk activity/animal food combinations.
31, 2014. We received 11 comments on
the draft RA and have revised it where II. Electronic Access
Qualitative Risk Assessment of Risk of
Activity/Animal Food Combinations for appropriate (Ref. 2). The RA and our response to
Activities (Outside the Farm Definition) The purpose of the RA is to provide comments on the draft RA are available
Conducted in a Facility Co-Located on a science-based risk analysis of those electronically at http://
a Farm; Availability activity/animal food combinations that www.regulations.gov, http://
would be considered low risk when www.fda.gov/downloads/
AGENCY: Food and Drug Administration, conducted in an animal food facility co- AnimalVeterinary/Products/Animal
HHS. located on a farm. We conducted this FoodFeeds/UCM366906.pdf, and http://
ACTION: Notification of availability. RA to satisfy FSMA’s requirements to
www.fda.gov/downloads/Food/Food
conduct a science-based risk analysis
SUMMARY: The Food and Drug ScienceResearch/UCM459595.pdf.
and to consider the results of that
Administration (FDA) is announcing the analysis in determining whether to III. References
availability of a document entitled exempt small or very small businesses
‘‘Qualitative Risk Assessment: Risk of that are engaged only in specific types The following references have been
Activity/Animal Food Combinations for of on-farm manufacturing, processing, placed on display in the Division of
Activities (Outside the Farm Definition) packing, or holding activities involving Dockets Management (HFA–305), Food
Conducted in a Facility Co-Located on specific animal food that we determine and Drug Administration, 5630 Fishers
a Farm’’ (the RA). The purpose of the to be low risk from requirements Lane, rm. 1061, Rockville, MD 20852
RA is to provide a science-based risk specified in sections 418 and 421 of the and may be seen by interested persons
analysis of those activity/animal food Federal Food, Drug, and Cosmetic Act between 9 a.m. and 4 p.m., Monday
combinations that would be considered (the FD&C Act) (21 U.S.C. 350g and through Friday, and are available
low risk when conducted in an animal 350j, respectively), or whether to modify electronically at http://
food facility co-located on a farm. We such requirements for such facilities. www.regulations.gov.
conducted this RA to satisfy See 78 FR 64428 through 64429 for 1. FDA, ‘‘Draft Qualitative Risk
requirements of the FDA Food Safety additional background information on Assessment: Risk of Activity/Animal Food
Modernization Act (FSMA) to conduct a FSMA, the requirements of sections 418 Combinations for Activities (Outside the
science-based risk analysis and to and 421 of the FD&C Act, the focus of Farm Definition) Conducted in a Facility Co-
consider the results of that analysis in the RA, the approach used, the nine Located on a Farm,’’ 2012. Available at
rulemaking that is required by FSMA. specific questions addressed by the RA, http://www.fda.gov/downloads/Animal
and our request for comments. Veterinary/Products/AnimalFoodFeeds/
DATES: September 17, 2015. UCM366906.pdf.
Before making the draft RA available
ADDRESSES: See the SUPPLEMENTARY 2. FDA, ‘‘Qualitative Risk Assessment. Risk
for public comment, we submitted an
INFORMATION section for electronic of Activity/Animal Food Combinations for
earlier version of the draft RA to a group Activities (Outside the Farm Definition)
access to the RA.
of scientific experts external to FDA for Conducted in a Facility Co-Located on a
FOR FURTHER INFORMATION CONTACT: peer review and revised that earlier Farm,’’ 2015. Available at http://
Mary J. Bartholomew, Center for version, as appropriate, considering the www.fda.gov/downloads/AnimalVeterinary/
Veterinary Medicine (HFV–200), Food experts’ comments. A report concerning Products/AnimalFoodFeeds/
and Drug Administration, 7519 Standish the external peer review is available for UCM459595.pdf.
Pl., Rockville, MD 20855, 240–402– public review and can be accessed from 3. FDA, ‘‘Peer Review Report. External Peer
6224. our Web site (Ref. 3). Review of the FDA/CVM Draft Qualitative
SUPPLEMENTARY INFORMATION: Elsewhere in this issue of the Federal Risk Assessment: Risk of Activity/Animal
Register, FDA is issuing a final rule to Food Combinations for Activities (Outside
I. Background implement section 418 of the FD&C Act the Farm Definition) Conducted in a Facility
Co-Located on a Farm,’’ 2013. Available at
In the Federal Register of October 29, for food for animals. That final rule http://www.fda.gov/ScienceResearch/
2013 (78 FR 64428), we announced the establishes current good manufacturing SpecialTopics/PeerReviewofScientific
availability of a draft qualitative risk practice requirements for animal food InformationandAssessments/
assessment (RA) (Ref. 1) related to facilities and establishes requirements ucm079120.htm.
manufacturing, processing, packing, and for certain animal food facilities to
Dated: August 31, 2015.
holding activities for animal food when conduct a hazard analysis and to
such activities are conducted in an identify and implement risk-based Leslie Kux,
animal food facility co-located on a preventive controls. In that final rule, Associate Commissioner for Policy.
farm. Interested parties were given the we use the results of the RA to exempt [FR Doc. 2015–21923 Filed 9–10–15; 8:45 am]
opportunity to submit comments by animal food facilities that are small or BILLING CODE 4164–01–P
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Document Created: 2015-12-15 09:33:54
Document Modified: 2015-12-15 09:33:54

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Notification of availability.
Dates		September 17, 2015.
Contact		Mary J. Bartholomew, Center for Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6224.
FR Citation		80 FR 56359

80 FR 56359 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 180 (September 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration