Vol. 78 Tuesday, 
No. 247 December 24, 2013 
Part IV 
Department of Health and Human Services 
Food and Drug Administration 
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 
VerDate Mar<15>2010 18:10 Dec 23, 2013 Jkt 232001 PO 00000 Frm 00001 Fmt 4717 Sfmt 4717 E:\FR\FM\24DEP3.SGM 24DEP3sroberts on DSK5SPTVN1PROD with PROPOSALS78064 Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Proposed Rules 
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. 
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 
VerDate Mar<15>2010 18:10 Dec 23, 2013 Jkt 232001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 E:\FR\FM\24DEP3.SGM 24DEP3sroberts on DSK5SPTVN1PROD with PROPOSALS78065 Federal Register / Vol. 78, No. 247 / Tuesday, December 24, 2013 / Proposed Rules 
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 
VerDate Mar<15>2010 18:10 Dec 23, 2013 Jkt 232001 PO 00000 Frm 00003 Fmt 4701 Sfmt 9990 E:\FR\FM\24DEP3.SGM 24DEP3sroberts on DSK5SPTVN1PROD with PROPOSALS