
[Federal Register Volume 78, Number 247 (Tuesday, December 24, 2013)]
[Proposed Rules]
[Pages 78063-78065]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30375]



[[Page 78063]]

Vol. 78

Tuesday,

No. 247

December 24, 2013

Part IV





Department of Health and Human Services





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Food and Drug Administration





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21 CFR Parts 16 and 121





Appendix 4 to 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; Proposed 
Rule

  Federal Register / Vol. 78 , No. 247 / Tuesday, December 24, 2013 / 
Proposed Rules  

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Department of Health and Human Services

Food and Drug Administration

21 CFR Parts 16 and 121

[Docket No. FDA-2013-N-1563]


Appendix 4 to 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

AGENCY: Food and Drug Administration, HHS.

ACTION: Request for comments.

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SUMMARY: On January 16, 2013, the Food and Drug Administration (FDA) 
announced the availability of, and requested 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 draft RA). FDA is now announcing 
the availability of, and requesting comment on, a document entitled 
``Appendix 4 to 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 draft RA Appendix). 
The purpose of the draft RA Appendix is to provide a science-based risk 
analysis of those foods whose production would be considered low risk 
with respect to the risk of intentional adulteration caused by acts of 
terrorism. The appendix supplements the science-based risk analysis 
already included in the draft RA, which does not consider the risk of 
intentional adulteration caused by acts of terrorism. FDA conducted 
this evaluation 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: Submit either electronic or written comments on the draft RA 
Appendix by March 31, 2014.

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: Ryan Newkirk, Center for Food Safety 
and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-3712.

SUPPLEMENTARY INFORMATION: 

I. Background

    On January 4, 2011, FSMA (Pub. L. 111-353) was signed into law. 
Section 103 of FSMA, Hazard analysis and risk-based preventive 
controls, amends the FD&C Act to create a new section 418 with the same 
name. Section 418 of the FD&C Act (21 U.S.C. 350g) contains 
requirements applicable to food facilities that are required to 
register under section 415 of the FD&C Act (21 U.S.C. 350d) and 
mandates Agency rulemaking. Section 418(a) of the FD&C Act is a general 
provision that requires the owner, operator, or agent in charge of a 
facility to evaluate the hazards that could affect food manufactured, 
processed, packed, or held by the facility, identify and implement 
preventive controls, monitor the performance of those controls, and 
maintain records of the monitoring. Section 418(a) of the FD&C Act 
specifies that the purpose of the preventive controls is to prevent the 
occurrence of such hazards and provide assurances that such food is not 
adulterated under section 402 of the FD&C Act (21 U.S.C. 342) or 
misbranded under section 403(w) of the FD&C Act (21 U.S.C. 343(w)). 
Section 418(b) of the FD&C Act requires that the hazard analysis 
identify and evaluate hazards that may be intentionally introduced, 
including by acts of terrorism. Sections 418(c) through (i) of the FD&C 
Act contain additional requirements applicable to facilities, including 
requirements for preventive controls (section 418(c)), monitoring 
(section 418(d)), corrective actions (section 418(e)), verification 
(section 418(f)), recordkeeping (section 418(g)), a written plan and 
documentation (section 418(h)), and reanalysis of hazards (section 
418(i)). On January 16, 2013, FDA issued a proposed rule (the proposed 
preventive controls rule for human food) to implement section 418 of 
the FD&C Act for human food with respect to hazards other than 
intentional adulteration (78 FR 3646). Elsewhere in this issue of the 
Federal Register, FDA is issuing a proposed rule entitled ``Focused 
Mitigation Strategies to Protect Food Against Intentional 
Adulteration'' (hereafter, the Intentional Adulteration proposed rule) 
to implement section 418 of the FD&C Act with respect to intentional 
adulteration caused by acts of terrorism.
    Among other things, section 103(c) of FSMA requires FDA to consider 
possible exemption from or modification of requirements of section 418 
and section 421 (U.S.C. 350j) (Targeting of inspection resources for 
domestic facilities, foreign facilities, and ports of entry; annual 
report) of the FD&C Act for certain facilities as FDA deems 
appropriate.
    Section 103(c)(1)(C) of FSMA directs the Secretary of Health and 
Human Services (the Secretary) to conduct a science-based risk analysis 
as part of the section 103(c) rulemaking. The science-based risk 
analysis is to cover: (1) Specific types of on-farm packing or holding 
of food that is not grown, raised, or consumed on such farm or another 
farm under the same ownership, as such packing and holding relates to 
specific foods and (2) specific on-farm manufacturing and processing 
activities as such activities relate to specific foods that are not 
consumed on that farm or on another farm under common ownership.
    Section 103(c)(1)(D)(i) of FSMA requires that the Secretary 
consider the results of the science-based risk analysis, and exempt 
certain facilities from the requirements in section 418 of the FD&C Act 
(including requirements related to intentional adulteration), and the 
mandatory inspection frequency in section 421 of the FD&C Act, or 
modify the requirements in sections 418 or 421, as the Secretary 
determines appropriate, if such facilities are engaged only in specific 
types of on-farm manufacturing, processing, packing, or holding 
activities that the Secretary determines to be low risk involving 
specific foods the Secretary determines to be low risk. Section 
103(c)(1)(D)(ii) of FSMA provides, in relevant part, that the 
exemptions or modifications described in section 103(c)(1)(D)(i) shall 
apply only to small businesses and very small businesses, as defined in 
the regulation issued under section 418(n) of the FD&C Act.

II. Qualitative Risk Assessment and Appendix

    On January 16, 2013, the Food and Drug Administration (FDA) 
announced the availability of, and requested 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 draft RA) (78 FR 3824).
    We conducted the qualitative risk assessment to identify activity/
food combinations that would be considered low risk for human foods 
with respect to hazards that may be unintentionally introduced to the 
food (Ref. 1).
    FDA is now announcing the availability of, and requesting comment 
on, a document entitled ``Appendix 4 to Draft Qualitative Risk 
Assessment of Risk of Activity/Food Combinations for

[[Page 78065]]

Activities (Outside the Farm Definition) Conducted in a Facility Co-
Located on a Farm'' (the draft RA Appendix) (Ref. 2). The purpose of 
the draft RA Appendix is to provide a science-based risk analysis of 
those foods whose production would be considered low risk with respect 
to the risk of intentional adulteration caused by acts of terrorism. 
The appendix supplements the science-based risk analysis already 
included in the draft RA, which does not consider the risk of 
intentional adulteration caused by acts of terrorism. In the 
Intentional Adulteration proposed rule, FDA is considering using the 
results of this evaluation to exempt, or modify requirements for, food 
facilities that are small or very small businesses that are engaged 
only in specific types of on-farm food production identified in the 
draft RA Appendix as low-risk with respect to intentional adulteration 
caused by acts of terrorism.
    In both risk assessments, we focused on food types produced on 
farms. When considering intentional adulteration, however, we 
considered the overall production practices for various types of 
finished foods rather than separating manufacturing, processing, 
packing, and holding activities (Ref. 2). This reflects the different 
analysis for ``low risk'' we used to evaluate the risk of hazards that 
may be intentionally introduced by acts of terrorism as compared to 
determining ``low risk'' for other hazards in the draft RA. In the 
draft RA Appendix, we describe the approach applied to identify low-
risk production processes and to determine food types out of the scope 
of the draft RA Appendix, and to evaluate hazards associated with foods 
within the scope of the draft RA Appendix (Ref. 2).
    We are seeking comments that can be used to improve: (1) the 
approach used, (2) the assumptions made, (3) the data used, and (4) the 
transparency of the draft RA Appendix. Specifically we request comment 
on: (1) The criteria for identifying a ``low-risk production process,'' 
and the approach to characterizing the risk of specific food production 
processes, including whether there are other ways in which we could 
further focus on foods that present a high risk of intentional 
adulteration caused by acts of terrorism. For example, whether there 
are ways in which a food's shelf life, turnover in the marketplace, 
batch size, serving size and servings per batch, distribution and 
consumption patterns and intended consumer could be considered and (2) 
the food types that we are considering outside the scope of the draft 
RA Appendix and those we are considering within the scope of the draft 
RA Appendix.
    We will consider public comments regarding the draft RA Appendix in 
preparing a final version of the RA Appendix and the Intentional 
Adulteration rule.

III. Comments

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

IV. Electronic Access

    The draft RA Appendix is available electronically at http://www.regulations.gov and at http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM377408.pdf.

V. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

    1. FDA, ``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,'' 2012. Available at: 
http://www.fda.gov/downloads/Food/FoodScienceResearch/UCM334110.pdf.
    2. FDA, ``Appendix 4 to 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,'' 2013. 
Available at: http://www.fda.gov/downloads/Food/FoodScienceResearch/RiskSafetyAssessment/UCM377408.pdf.

    Dated: December 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30375 Filed 12-20-13; 8:45 am]
BILLING CODE 4160-01-P


