80_FR_56537 80 FR 56357 - 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

80 FR 56357 - 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

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Page Range56357-56358
FR Document2015-21922

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.

Federal Register, Volume 80 Issue 180 (Thursday, September 17, 2015) 
[Federal Register Volume 80, Number 180 (Thursday, September 17, 2015)]
[Rules and Regulations]
[Pages 56357-56358]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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]
BILLING CODE 4164-01-P

Vol. 80 Thursday, No. 180 September 17, 2015 Part IV Department of Health and Human Services Food and Drug Administration 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 tkelley on DSK3SPTVN1PROD with RULES4 VerDate Sep<11>2014 20:08 Sep 16, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\17SER4.SGM 17SER4

56358 Federal Register / Vol. 80, No. 180 / Thursday, September 17, 2015 / Rules and Regulations DEPARTMENT OF HEALTH AND modeling techniques, the data used, and www.regulations.gov, http://www.fda. HUMAN SERVICES the clarity and the transparency of the gov/Food/FoodScienceResearch/Risk RA documentation. We received more SafetyAssessment/default.htm, and Food and Drug Administration than two dozen comments on the draft http://www.fda.gov/ScienceResearch/ RA and have revised it where SpecialTopics/PeerReviewofScientific 21 CFR Part 117 appropriate (Refs. 2 and 3). InformationandAssessments/ [Docket No. FDA–2012–N–1258] The purpose of the RA is to provide ucm079120.htm. a science-based risk analysis of those activity/food combinations that would III. References Qualitative Risk Assessment of Risk of Activity/Food Combinations for be considered low risk when conducted The following references have been Activities (Outside the Farm Definition) in a food facility co-located on a farm. placed on display in the Division of Conducted in a Facility Co-Located on We conducted this RA to satisfy FSMA’s Dockets Management (HFA–305), Food a Farm; Availability requirements to conduct a science-based and Drug Administration, 5630 Fishers risk analysis and to consider the results Lane, rm. 1061, Rockville, MD 20852, AGENCY: Food and Drug Administration, of that analysis in determining whether HHS. and may be seen by interested persons to exempt small or very small between 9 a.m. and 4 p.m., Monday ACTION: Notification of availability. businesses that are engaged only in through Friday, and are available SUMMARY: The Food and Drug specific types of on-farm manufacturing, electronically at http://www. Administration (FDA) is announcing the processing, packing, or holding regulations.gov. availability of a document entitled activities involving specific foods that we determine to be low risk from 1. FDA, ‘‘Draft Qualitative Risk ‘‘Qualitative Risk Assessment of Risk of Assessment. Risk of Activity/Food Activity/Food Combinations for requirements specified in sections 418 Combinations for Activities (Outside the Activities (Outside the Farm Definition) and 421 of the Federal Food, Drug, and Farm Definition) Conducted in a Facility Co- Conducted in a Facility Co-Located on Cosmetic Act (the FD&C Act) (21 U.S.C. Located on a Farm,’’ 2012. Available at: a Farm’’ (the RA). The purpose of the 350g and 21 U.S.C. 350j, respectively), http://www.fda.gov/Food/FoodScience RA is to provide a science-based risk or whether to modify such requirements Research/RiskSafetyAssessment/default.htm analysis of those activity/food for such facilities. See 78 FR 3824 at and http://www.fda.gov/ScienceResearch/ combinations that would be considered 3825 to 3826 for additional background SpecialTopics/PeerReviewofScientific information on FSMA, the requirements InformationandAssessments/ low risk when conducted in a food ucm079120.htm. See Reference 1 to the facility co-located on a farm. We of sections 418 and 421 of the FD&C Act, the focus of the RA, the approach notice of availability of the draft risk conducted this RA to satisfy assessment. requirements of the FDA Food Safety used, the nine specific questions 2. FDA, ‘‘Qualitative Risk Assessment. Risk Modernization Act (FSMA) to conduct a addressed by the RA, and our request of Activity/Food Combinations for Activities science-based risk analysis and to for comments. (Outside the Farm Definition) Conducted in Before making the draft RA available a Facility Co-Located on a Farm,’’ 2015. consider the results of that analysis in for public comment, we submitted an Available at: http://www.fda.gov/Food/Food rulemaking that is required by FSMA. earlier version of the draft RA to a group ScienceResearch/RiskSafetyAssessment/ DATES: September 17, 2015. of scientific experts external to FDA for default.htm and http://www.fda.gov/Science ADDRESSES: See the SUPPLEMENTARY peer review and revised that earlier Research/SpecialTopics/PeerReviewof INFORMATION section for electronic version, as appropriate, considering the ScientificInformationandAssessments/ access to the RA. experts’ comments. A report concerning ucm079120.htm. FOR FURTHER INFORMATION CONTACT: the external peer review is available for 3. FDA, ‘‘Qualitative Risk Assessment. Risk Jenny Scott, Center for Food Safety and public review and can be accessed from of Activity/Food Combinations for Activities Applied Nutrition (HFS–300), Food and our Web site (Ref. 4). (Outside the Farm Definition) Conducted in Drug Administration, 5100 Paint Branch Elsewhere in this issue of the Federal a Facility Co-Located on a Farm. Response to Pkwy., College Park, MD 20740, 240– Public Comments,’’ 2015. Available at: http:// Register, FDA is issuing a final rule to www.fda.gov/Food/FoodScienceResearch/ 402–2166. implement section 418 of the FD&C Act RiskSafetyAssessment/default.htm and SUPPLEMENTARY INFORMATION: for human food. That final rule http://www.fda.gov/ScienceResearch/Special establishes requirements for certain food Topics/PeerReviewofScientificInformation I. Background facilities to conduct a hazard analysis andAssessments/ucm079120.htm. In the Federal Register of January 16, and to identify and implement risk- 4. FDA, ‘‘Peer Review Report. External Peer 2013 (78 FR 3824), we announced the based preventive controls. In that final Review of the FDA/CFSAN Draft Qualitative availability of a draft qualitative risk rule, we use the results of the RA to Risk Assessment: Risk of Activity/Food assessment (RA) (Ref. 1) related to exempt food facilities that are small or Combinations for Activities (Outside the manufacturing, processing, packing, and very small businesses, co-located on a Farm Definition) Conducted in a Facility Co- holding activities for human food when Located on a Farm,’’ 2012. Available at: farm, from these requirements when such activities are conducted in a food http://www.fda.gov/ScienceResearch/Special such facilities are engaged only in Topics/PeerReviewofScientificInformation facility co-located on a farm. We specific types of on-farm manufacturing, andAssessments/ucm079120.htm. See reopened the comment period on March processing, packing, or holding Reference 3 to the notice of availability of the 13, 2013 (78 FR 15894) and also activities identified in the RA as low- draft risk assessment. extended the comment period on April risk activity/food combinations. Dated: August 31, 2015. 26, 2013 (78 FR 24693). We gave tkelley on DSK3SPTVN1PROD with RULES4 interested parties an opportunity to II. Electronic Access Leslie Kux, submit comments by September 16, The RA and our response to Associate Commissioner for Policy. 2013, for us to consider on the approach comments on the draft RA are available [FR Doc. 2015–21922 Filed 9–10–15; 8:45 am] used, the assumptions made, the electronically at http:// BILLING CODE 4164–01–P VerDate Sep<11>2014 20:08 Sep 16, 2015 Jkt 235001 PO 00000 Frm 00002 Fmt 4701 Sfmt 9990 E:\FR\FM\17SER4.SGM 17SER4


Document Created: 2015-12-15 09:34:08
Document Modified: 2015-12-15 09:34:08
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionNotification of availability.
DatesSeptember 17, 2015.
ContactJenny 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.
FR Citation80 FR 56357 
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