[Federal Register Volume 78, Number 11 (Wednesday, January 16, 2013)]
[Proposed Rules]
[Pages 3824-3826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-124]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2012-N-1258]


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: Notification; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of, and requesting 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). The purpose of the draft RA is to 
provide a science-based risk analysis of those activity/food 
combinations that would be considered low risk. FDA conducted this 
draft 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. 
Elsewhere in this issue of the Federal Register, FDA is using the 
results of the draft RA to propose to exempt food facilities that are 
small or very small businesses that are engaged only in specific types 
of on-farm manufacturing, processing, packing, or holding activities 
identified in the draft RA as low-risk activity/food combinations from 
the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
for hazard analysis and risk-based preventive controls.

DATES: Submit either electronic or written comments on the draft RA by 
February 15, 2013.

ADDRESSES: Submit electronic comments to http://

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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: 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

    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 (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 
known or reasonably foreseeable hazards that may be associated with the 
facility. Sections 418(c)-(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)). Elsewhere 
in this issue of the Federal Register, FDA is issuing a proposed rule 
(the proposed preventive controls rule) to implement section 418 of the 
FD&C Act.
    Section 103(c) of FSMA requires rulemaking in two areas: (1) 
Clarification of the activities that are included as part of the 
definition of the term ``facility'' under section 415 of the FD&C Act 
(Registration of food facilities) and (2) 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 415 of the 
FD&C Act directs FDA to require by regulation that any facility engaged 
in manufacturing, processing, packing, or holding food for consumption 
in the United States be registered with FDA. The registration 
requirement in section 415 of the FD&C Act does not apply to farms. Our 
regulations that implement section 415 and require food facilities to 
register with FDA are established in part 1 (21 CFR part 1), subpart H 
(Registration of food facilities) (hereinafter the section 415 
registration regulations).
    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 (including 
requirements for hazard analysis and preventive controls), and the 
mandatory inspection frequency in section 421, or modify the 
requirements in sections 418 or 421 of the FD&C Act, 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 promulgated under section 418(n) of the FD&C Act.

II. Qualitative Risk Assessment

    As explained in the draft RA, we conducted the qualitative risk 
assessment to identify activity/food combinations that would be 
considered low risk (Ref. 1). We focused on activity/food combinations 
that we identified as being conducted on farms, but we did not consider 
activity/food combinations that would be solely within the farm 
definition (such as growing fruits and vegetables) and, thus, are not 
relevant to the requirements of section 103 of FSMA. We considered the 
risk of activity/food combinations rather than separately considering 
the risk of specific food categories because doing so better enabled us 
to focus on whether a specific manufacturing, processing, packing, or 
holding activity conducted on food on a farm warranted an exemption 
from, or modified requirements for, the provisions of section 418 of 
the FD&C Act. In the remainder of this document, we use the term ``farm 
mixed-type facility'' to refer to an establishment that grows and 
harvests crops or raises animals and may conduct other activities 
applicable to farms and to food facilities co-located on farms.
    In the draft RA, we describe the approach applied to define a low-
risk activity and low-risk activity/food combinations to determine food 
types out of scope of the draft RA, and to evaluate hazards associated 
with foods within the scope of the draft RA (Ref. 1). We followed the 
risk assessment framework of the Codex Alimentarius Commission (Ref. 
2), which involves hazard identification, hazard characterization, 
exposure assessment, and risk characterization. The draft RA addresses 
nine specific questions:
    Question 1: What are the foods that would be manufactured, 
processed, packed, or held by a farm mixed-type facility?
    Question 2: What are the activities that might be conducted by farm 
mixed-type facilities on those foods?
    Question 3: What are the hazards reasonably likely to occur in 
those foods?
    Question 4: For the purpose of determining whether an activity/food 
combination is low risk, which hazards should be considered to have a 
reasonable probability of causing serious adverse health consequences 
or death?
    Question 5: For the purpose of determining whether an activity/food 
combination is low risk, what foods have inherent controls that 
significantly minimize or prevent a biological hazard that is 
reasonably likely to occur in these foods and that is reasonably likely 
to cause serious adverse health consequences or death?
    Question 6: What interventions significantly minimize or prevent a

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hazard that is reasonably likely to occur in these foods and that is 
reasonably likely to cause serious adverse health consequences or 
death?
    Question 7: Which of these activities are reasonably likely to 
introduce, or increase the potential for occurrence of, hazards that 
are reasonably likely to cause serious adverse health consequences or 
death and what are these hazards?
    Question 8: Which of these activities are interventions to 
significantly minimize or prevent hazards that are reasonably likely to 
cause serious adverse health consequences or death from consumption of 
these foods?
    Question 9: Which activity/food combinations are low risk, i.e., 
what on-farm activity/food combinations are not reasonably likely to 
introduce hazards that are reasonably likely to cause serious adverse 
health consequences or death or serve as preventive controls 
(interventions) to significantly minimize or prevent a hazard that is 
reasonably likely to cause serious adverse health consequences or 
death?
    As discussed in the draft RA, a specific activity may have a 
different classification within the classes of manufacturing, 
processing, packing, and holding (with consequences for what 
regulations apply to the activity) based on whether the food being 
operated upon is a raw agricultural commodity (RAC) or a processed food 
and whether a RAC was grown or raised on the farm performing the 
activity or a farm under the same ownership (Ref. 1). In the draft RA, 
we first characterize the risk of activity/food combinations without 
the overlay of the applicable statutory and regulatory framework. Doing 
so focuses the risk characterization on the risk of the activity/food 
combinations themselves. We then add that regulatory overlay and 
characterize the risk of activity/food combinations in three regulatory 
groups shaped by the applicable regulatory factors and the resulting 
activity classifications:
     Regulatory Group Type 1: Low-risk packing and holding 
activities that might be conducted on a farm on food not grown, raised, 
or consumed on that farm or another farm under the same ownership;
     Regulatory Group Type 2: Low-risk manufacturing and 
processing activities that might be conducted on a farm on the farm's 
own RACs for distribution into commerce; and
     Regulatory Group Type 3: Low-risk manufacturing and 
processing activities that might be conducted on a farm on food other 
than the farm's own RACs for distribution into commerce.
    We are seeking comments that can be used to improve:
     The approach used;
     The assumptions made;
     The data used; and
     The transparency of the draft RA.
    Specifically we request comment on:
     The definitions of ``low-risk activity'' and ``low-risk 
activity/food combination'';
     The food types and activity/food combinations that we are 
considering outside the scope of the draft RA and those we are 
considering within the scope of the draft RA;
     The approach to characterizing the risk of an activity/
food combination;
     The questions addressed by the draft RA; and
     The answers to those questions.
    We submitted a draft RA to a group of scientific experts external 
to FDA for peer review and revised the draft RA, 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). We will consider public comments regarding the draft 
RA in preparing a final version of the RA.

III. Comments

    Interested persons may submit either electronic comments to http://www.regulations.gov or written comments regarding the draft RA 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 is available electronically at http://www.regulations.gov and at http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default.htm.

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. 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/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/default.htm.
    2. Codex Alimentarius Commission, ``Codex Alimentarius 
Commission Procedural Manual, Twentieth Edition,'' 2011.
    3. 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.


    Dated: January 3, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-124 Filed 1-4-13; 11:15 am]
BILLING CODE 4160-01-P