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, 64428-64430 [2013-25124]
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Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Proposed Rules
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.
Notification; request for
comments.
ACTION:
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 sciencebased 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 https://
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.
SUMMARY:
SUPPLEMENTARY INFORMATION:
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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
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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
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Sfmt 4702
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 sciencebased 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 onfarm 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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Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Proposed Rules
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 mixedtype 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,
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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;
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64429
• 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 https://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 https://
www.regulations.gov.
IV. Electronic Access
The draft RA is available
electronically at https://
www.regulations.gov and https://
www.fda.gov/downloads/Animal
Veterinary/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 https://
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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Federal Register / Vol. 78, No. 209 / Tuesday, October 29, 2013 / Proposed Rules
Farm Definition) Conducted in a Facility CoLocated on a Farm,’’ 2012. Available at
https://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
https://www.fda.gov/ScienceResearch/
SpecialTopics/PeerReviewofScientific
InformationandAssessments/
ucm079120.htm.
ADDRESSES:
Dated: October 21, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
SUPPLEMENTARY INFORMATION:
BILLING CODE 4160–01–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–112815–12]
RIN 1545–BK99
Mixed Straddles; Straddle-by-Straddle
Identification Under Section
1092(b)(2)(A)(i)(I); Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
by cross-reference to temporary
regulations and notice of public hearing;
correction.
AGENCY:
This document contains
amendments to proposed regulations
relating to guidance for taxpayers
electing to establish a mixed straddle
using straddle-by-straddle
identification. These amendments
include a change to the applicability
date of the proposed regulations
pursuant to which the proposed
regulations would apply to transactions
established after the date of publication
of the Treasury decision adopting these
rules as final regulations in the Federal
Register. The amendments to the
proposed regulations will affect
taxpayers who elect to establish a mixed
straddle using straddle-by-straddle
identification.
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SUMMARY:
Comments must be received by
October 31, 2013. Request to speak and
outlines of topics to be discussed at the
public hearing scheduled for December
4, 2013, at 10 a.m. must be received by
October 31, 2013.
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Amendments to the Regulations
FOR FURTHER INFORMATION CONTACT:
■
Pamela Lew or Robert B. Williams at
(202) 622–3950 (not a toll-free number).
Background
[FR Doc. 2013–25124 Filed 10–25–13; 8:45 am]
DATES:
Send submissions to:
CC:PA:LPD:PR (REG–112815–12), room
5205, Internal Revenue Service, PO Box
7604, Ben Franklin Station, Washington,
DC 20044. Submissions may be handdelivered Monday through Friday
between the hours of 8 a.m. and 4 p.m.
to CC:PA:LPD:PR (REG–112815–12),
Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue NW.,
Washington, DC, or sent electronically
via the Federal eRulemaking Portal at
www.regulations.gov (IRS REG–112815–
12).
The proposed regulations that are the
subject of these amendments are under
section 1092 of the Internal Revenue
Code (Code). The text of temporary
regulations (TD 9627), published in the
Federal Register on Friday, August 2,
2013 (78 FR 46807), serves as the text
of the proposed regulations. The
proposed regulations (REG–112815–12)
were published in the Federal Register
on Friday, August 2, 2013 (78 FR
46854). The proposed regulations were
proposed to apply to all identified
mixed straddles established after the
date of filing, August 1, 2013.
The Treasury Department and the IRS
received comments raising concerns
about the immediate applicability date
of the temporary regulations. In
response to those comments, the
Treasury Department and the IRS are
amending the temporary regulations to
limit the application of the identified
mixed straddle transaction rules in
§ 1.1092(b)-6T to section 1092(b)(2)
identified mixed straddles established
after the date of publication of the
Treasury decision adopting the rules as
final regulations in the Federal Register.
The text of the temporary regulations, as
amended, continues to serve as the text
of these proposed regulations, and this
document amends the proposed
regulations to conform to the changes to
the temporary regulations. The Treasury
Department and the IRS anticipate
finalizing the regulations no later than
the end of the current Priority Guidance
Plan year on June 30, 2014, and will as
part of that process consider all
comments received.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Frm 00023
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PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 is amended by adding entries
in numerical order to read as follows:
■
Authority: 26 U.S.C. 7805 * * *.
Section 1.1092(b)–6 also issued under 26
U.S.C. 1092(b)(1).
Section 1.1092(b)–6 also issued under 26
U.S.C. 1092(b)(2).* * *
Par. 2. Section 1.1092(b)–6 is
amended by revising the heading to read
as follows:
§ 1.1092(b)–6 Mixed straddles; accrued
gain and loss associated with a position
that becomes part of a section 1092(b)(2)
identified mixed straddle.
*
*
*
*
*
Martin Franks,
Branch Chief, Publications & Regulations
Branch, Legal Processing Division, Associate
Chief Counsel, (Procedure & Administration).
[FR Doc. 2013–25360 Filed 10–25–13; 8:45 am]
BILLING CODE 4830–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR part 52
[EPA–R09–OAR–2013–0663; FRL–9902–10–
Region9]
Need for amendments
PO 00000
Accordingly, 26 CFR part 1 is
proposed to be amended as follows:
Partial Approval and Disapproval of Air
Quality State Implementation Plans;
Nevada; Infrastructure Requirements
for Lead (Pb)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to partially
approve and partially disapprove State
Implementation Plan (SIP) revisions
submitted by the State of Nevada on
October 12, 2011, July 23, 2012, and
August 30, 2012, pursuant to the
requirements of the Clean Air Act (CAA
or the Act) for the implementation,
maintenance, and enforcement of the
2008 Lead (Pb) national ambient air
quality standards (NAAQS). We refer to
such SIP revisions as ‘‘infrastructure’’
SIPs because they are intended to
address basic structural SIP
requirements for new or revised NAAQS
including, but not limited to, legal
authority, regulatory structure,
resources, permit programs, monitoring,
and modeling necessary to assure
attainment and maintenance of the
standards. We are taking comments on
SUMMARY:
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]]>Agencies
[Federal Register Volume 78, Number 209 (Tuesday, October 29, 2013)]
[Proposed Rules]
[Pages 64428-64430]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25124]
[[Page 64428]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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
[[Page 64429]]
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 https://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 https://www.regulations.gov.
IV. Electronic Access
The draft RA is available electronically at https://www.regulations.gov and https://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 https://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
[[Page 64430]]
Farm Definition) Conducted in a Facility Co-Located on a Farm,''
2012. Available at https://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 https://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
