[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Proposed Rules]
[Pages 64428-64430]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-25124]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 507

[Docket No. FDA-2013-N-1043]


Draft 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; 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/Animal 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/
animal 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.

DATES: Submit either electronic or written comments on the draft RA by 
February 26, 2014.

ADDRESSES: Submit electronic comments on the draft RA to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mary J. Bartholomew, Center for 
Veterinary Medicine (HFV-200), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-8172.

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 Federal Food, Drug, and Cosmetic Act (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 (including animal 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). 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) to 
(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 for food for animals) to implement section 418 of the 
FD&C Act. FDA is using the results of the draft RA to propose to exempt 
animal 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/animal food combinations from the requirements of the FD&C Act 
for hazard analysis and risk-based preventive controls.
    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 (21 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 human or 
animal 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 21 CFR part 1, 
subpart H (Registration of Food Facilities).
    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 animal 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 animal foods and (2) specific on-farm manufacturing 
and processing activities as such activities relate to specific animal 
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 for hazard analysis and preventive controls) 
and the mandatory inspection frequency in section 421 of the FD&C Act, 
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 animal 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

    As explained in the draft RA, we conducted the qualitative risk 
assessment to identify activity/animal food combinations that would be 
considered low risk (Ref. 1). We focused on activity/animal food 
combinations that we identified as being conducted on farms, but we did 
not consider activity/animal food combinations that would be solely 
within the farm definition (such as growing grains) and, thus, are not 
relevant to the requirements of section 103 of FSMA. We considered the 
risk of activity/animal food combinations rather than separately 
considering the risk of

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specific animal food categories because doing so better enabled us to 
focus on whether a specific manufacturing, processing, packing, or 
holding activity conducted on animal 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 animal 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/animal food combinations to 
determine activities on animal food that are out of scope of the draft 
RA, and to evaluate hazards associated with activity/animal food 
combinations 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 animal 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 animal foods?
    Question 3: What are the hazards reasonably likely to occur in 
those animal foods?
    Question 4: For the purpose of determining whether an activity/
animal food combination is low risk, which hazards should be considered 
to have a reasonable probability of causing serious adverse health 
consequences or death to humans or animals?
    Question 5: For the purpose of determining whether an activity/
animal food combination is low risk, what animal foods have inherent 
controls that significantly minimize or prevent a biological hazard 
that is reasonably likely to occur in these animal foods and that is 
reasonably likely to cause serious adverse health consequences or death 
to humans or animals?
    Question 6: What interventions significantly minimize or prevent a 
hazard that is reasonably likely to occur in these animal foods and 
that is reasonably likely to cause serious adverse health consequences 
or death to humans or animals?
    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 to humans or animals 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 to humans or animals 
from consumption of these animal foods?
    Question 9: Which activity/animal food combinations are low risk, 
i.e., what on-farm activity/animal food combinations are not reasonably 
likely to introduce hazards that are reasonably likely to cause serious 
adverse health consequences or death to humans or animals 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 to humans or animals?
    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 animal food 
being operated upon is a raw agricultural commodity (RAC) or a 
processed animal 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/animal food 
combinations without the overlay of the applicable statutory and 
regulatory framework. Doing so focuses the risk characterization on the 
risk of the activity/animal food combinations themselves. We then add 
that regulatory overlay and characterize the risk of activity/animal 
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 animal 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 animal 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/animal food combination'';
     The animal food types and activity/animal 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/
animal 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 regarding 
the draft RA 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 is available electronically at http://www.regulations.gov and http://www.fda.gov/downloads/AnimalVeterinary/Products/AnimalFoodFeeds/UCM366906.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 person between 9 a.m. and 4 p.m., Monday through Friday, and 
are available electronically at http://www.regulations.gov. (FDA has 
verified all the Web site addresses in this references section, 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/
Animal Food Combinations for Activities (Outside the

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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. Codex Alimentarius Commission, ``Codex Alimentarius 
Commission Procedural Manual, Twentieth Edition,'' 2011.
    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: October 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25124 Filed 10-25-13; 8:45 am]
BILLING CODE 4160-01-P