[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Proposed Rules]
[Pages 58476-58521]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22445]
[[Page 58475]]
Vol. 79
Monday,
No. 188
September 29, 2014
Part III
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 16, 117, and 507
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals; Proposed Rule
Federal Register / Vol. 79 , No. 188 / Monday, September 29, 2014 /
Proposed Rules
[[Page 58476]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 16, 117, and 507
[Docket No. FDA-2011-N-0922]
RIN 0910-AG10
Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; supplemental notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (FDA or we) is proposing to
amend our 2013 proposed rule for Current Good Manufacturing Practice
(CGMP) and Hazard Analysis and Risk-Based Preventive Controls for Food
for Animals. In that 2013 proposed rule, we proposed to add CGMP
requirements for animal food and to add requirements for certain
domestic and foreign facilities to establish and implement hazard
analysis and risk-based preventive controls for food for animals. We
are taking this action because the input we have received from public
comments has led to significant changes in our current thinking on
certain key provisions of this proposed rule. We are reopening the
comment period only with respect to specific issues identified in this
proposed rule.
DATES: Submit either electronic or written comments on the proposed
rule by December 15, 2014. Submit comments on information collection
issues under the Paperwork Reduction Act of 1995 by December 15, 2014
(see the ``Paperwork Reduction Act of 1995'' section of this document).
ADDRESSES: You may submit comments by any of the following methods,
except that comments on information collection issues under the
Paperwork Reduction Act of 1995 must be submitted to the Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB) (see the ``Paperwork Reduction Act of 1995'' section of this
document).
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Docket No
2011-N-0922 for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kim Young, Center for Veterinary
Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9207, email: [email protected].
SUPPLEMENTARY INFORMATION:
Table of Contents
Executive Summary
Purpose and Coverage of the Supplemental Notice of Proposed
Rulemaking
Summary of the Major Provisions of the Supplemental Notice of
Proposed Rulemaking
Costs and Benefits
I. Background
A. Introduction
B. 2013 Proposed Rule for Preventive Controls for Food for
Animals
II. Public Comments
A. Opportunities for Public Comment
B. Overview of Public Comments on the 2013 Proposed Rule for
Preventive Controls
C. Our Decision To Issue a Supplemental Notice of Proposed
Rulemaking for Public Comment
III. Scope of the Supplemental Notice of Proposed Rulemaking and Our
Request for Public Comment
IV. Legal and Regulatory Framework Under Sections 415 and 418 of the
FD&C Act and Regulations Implementing Section 415 of the FD&C Act
V. The ``Farm'' Definition
A. 2013 Proposed Definitions of ``Farm,'' ``Harvesting,''
``Holding,'' and ``Packing''
B. Proposed Revisions to the Proposed Definitions of ``Farm,''
``Harvesting,'' ``Holding,'' and ``Packing''
C. One General Physical Location
D. Feed Mills Associated With Contract and Fully Vertically
Integrated Farming
VI. Definitions of ``Holding'' and ``Packing''
A. 2013 Proposed Definition of ``Holding''
B. 2013 Proposed Exemptions Relevant to the Definition of
``Holding''
C. Comments on the 2013 Proposed Exemption for a Facility Solely
Engaged in the Storage of RACs (Other Than Fruits and Vegetables)
Intended for Further Distribution or Processing
D. Comments on the 2013 Proposed Exemption for a Facility Solely
Engaged in the Storage of Packaged Food That Is Not Exposed to the
Environment
E. Proposed Revisions to the Definition of ``Holding''
F. Proposed Revisions to the Definition of ``Packing''
VII. Impact of the Proposed Revisions to the Farm-Related
Definitions on the Classification of On-Farm Activities
A. Comments on the 2013 Organizing Principles for Classifying
Activities Conducted on Farms and on Farm Mixed-Type Facilities
B. Updated Organizing Principles That Would Apply to the
``Farm'' Definition
C. Changes to Classification of On-Farm Activities
VIII. Proposed Exemptions for On-Farm Low-Risk Activity/Animal Food
Combinations
A. The 2013 Proposed Exemptions
B. Comments on the 2013 Proposed Exemptions for On-Farm Low-Risk
Activity/Animal Food Combinations
C. Impact of the Proposed Revisions to the Definitions for
``Farm,'' ``Harvesting,'' Holding,'' and ``Packing'' on the 2013
Proposed Exemptions for On-Farm Low-Risk Activity/Animal Food
Combinations
IX. Proposed Applicability of Part 507 to the Holding and
Distribution of Human Food By-Products for Use in Animal Food
X. Proposed Revisions to Subpart B--Current Good Manufacturing
Practice
XI. Overall Framework for Hazard Analysis and Risk-Based Preventive
Controls
A. 2013 Proposed Overall Framework for Hazard Analysis and Risk-
Based Preventive Controls
B. Comments on the ``Reasonably Likely To Occur'' Construct
Within the 2013 Overall Framework for Hazard Analysis and Risk-Based
Preventive Controls
C. Proposed Revisions to the Overall Framework for Hazard
Analysis and Risk-Based Preventive Controls
XII. Potential Requirements for Product Testing and Environmental
Monitoring
A. Our Request for Comment on Including Requirements for Product
Testing and Environmental Monitoring in a Final Rule
B. Product Testing
C. Environmental Monitoring
XIII. Potential Requirements for a Supplier Program
A. Our Request for Comment on When and How Supplier Verification
Activities Are an Appropriate Means of Implementing the Statutory
Framework of Section 418 of the FD&C Act
B. Comments on When and How Supplier Verification Activities Are
an Appropriate Means of Implementing the
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Statutory Framework of Section 418 of the FD&C Act
C. Potential Requirements for a Supplier Program
D. Request for Additional Comment on Requirements To Address
Conflicts of Interest for Persons Conducting Verification Activities
XIV. Potential Requirements for the Hazard Analysis To Address
Economically Motivated Adulteration
A. Our Request for Comment on Whether the Final Rule Should
Address Economically Motivated Adulteration
B. Comments on Economically Motivated Adulteration
C. Potential Requirements To Address Economically Motivated
Adulteration
XV. Provisions for Withdrawal of an Exemption for a Qualified
Facility
A. 2013 Proposed Provisions for Withdrawal of an Exemption for a
Qualified Facility
B. Proposed Clarification of What FDA Will Do Before Issuing an
Order and Proposed Mechanism for Re-Instating an Exemption
C. Proposed Revisions to the Content of an Order To Withdraw an
Exemption
D. Proposed Revisions to the Timeframes for a Facility To Comply
With, or Appeal, an Order
XVI. Definition of Very Small Business
A. The 2013 Proposed Options for Definition of Very Small
Business
B. Comments on the 2013 Proposed Options for Definition of Very
Small Business
C. Proposed Revisions to the Definition of Very Small Business
XVII. Other New and Revised Proposed Provisions
A. Proposed New Definitions
B. Proposed Revisions to Definitions
C. Proposed Editorial Changes
D. Proposed Conforming Change to Proposed Part 117
XVIII. Preliminary Regulatory Impact Analysis
A. Overview
B. Regulatory Flexibility Act
C. Small Business Regulatory Enforcement Fairness Act of 1996
D. Unfunded Mandates Reform Act of 1995
XIX. Paperwork Reduction Act of 1995
XX. Analysis of Environmental Impact
XXI. Comments
XXII. References
Executive Summary
Purpose and Coverage of the Supplemental Notice of Proposed Rulemaking
We previously proposed to add requirements for certain domestic and
foreign facilities to establish and implement hazard analysis and risk-
based preventive controls for food for animals, as required by the FDA
Food Safety Modernization Act (FSMA). The proposed requirements would
apply to establishments that are required to register with us as an
animal food ``facility.'' In this document we are proposing to revise
several previously proposed requirements, taking into account the
comments we have reviewed so far for the proposed rule for preventive
controls for food for animals and the proposed rule for preventive
controls for human food, because the extensive input we have received
from public comments has led to significant changes in our current
thinking on certain key provisions.
In the 2013 proposed rule, we asked for comment on when and how
three provisions (i.e., product testing programs, environmental
monitoring programs, and supplier programs) are an appropriate means of
implementing the statutory directives of FSMA. We also requested
comment on whether a facility should be required to address potential
hazards that may be intentionally introduced for economic reasons. Some
comments received to the 2013 proposed rule assert that additional
public comment is warranted before consideration is given to whether a
final rule includes or does not include provisions that were discussed
in the 2013 proposal but for which we had not included regulatory text
in the 2013 proposal. In this document we are providing an opportunity
for such public comment on potential requirements for product testing
programs, environmental monitoring programs, and supplier programs, and
hazards that may be intentionally introduced for purposes of economic
gain, which take into account the comments we have reviewed so far. We
are seeking comment on whether such requirements should be included in
a final rule and, if so, what (if any) modifications to the proposed
regulatory text would be appropriate.
In the 2013 proposed rule, we requested comment on three options
for classifying a facility as a ``very small business,'' with
consequences for facilities in terms of eligibility for exemptions and
the timeframe to comply with this rule. In this document we are
proposing a definition for ``very small business'' (i.e., a business
that has less than $2,500,000 in total annual sales of animal food
adjusted for inflation).
We are proposing a revised version of the 2013 proposed current
good manufacturing practice regulations. In addition, we added a
section to the proposed current good manufacturing practice regulations
for holding and distribution of human food by-products for food for
animals. This would apply to human food facilities that hold and
distribute by-products from the human food production that are used for
food for animals.
Summary of the Major Provisions of the Supplemental Notice of Proposed
Rulemaking
The previously proposed (2013) current good manufacturing practice
requirements (CGMPs) were based, in general, on FDA's existing human
food CGMP regulations. The revised proposed CGMPs for food for animals
would establish baseline standards for producing safe animal food that
are more applicable to the animal food industry and that provide
flexibility for the wide diversity in types of animal food facilities.
Human food processors already complying with FDA human food safety
requirements would not need to implement additional preventive controls
or Current Good Manufacturing Practice regulations when supplying a by-
product, except those proposed for the holding and distribution of
certain human food by-products for food for animals (e.g., ensuring by-
product is not co-mingled with garbage). Under the revised proposal,
all other requirements of part 507, including the hazard analysis and
preventive controls requirements, would not apply to these by-products
of human food production.
The previously proposed requirements for hazard analysis and risk-
based preventive controls applied a construct previously used in our
Hazard Analysis and Critical Control Point (HACCP) regulations for
seafood and juice--i.e., whether a known or reasonably foreseeable
hazard was ``reasonably likely to occur.'' In general, our HACCP
regulations for seafood and juice focus on critical control points to
control hazards that are ``reasonably likely to occur.'' We are
proposing to eliminate the term ``hazard reasonably likely to occur''
throughout the proposed requirements to reduce the potential for a
misinterpretation that all necessary preventive controls must be
established at critical control points (CCPs). The revised regulations
would use a new term (``significant hazard'') in its place.
The defined term ``significant hazard'' would be linked to the
facility's hazard analysis, which addresses risk (i.e., both the
severity of a potential hazard and the probability that the hazard will
occur). Thus, this term would reflect the risk-based nature of the
requirements. In addition, the revised regulations would provide
additional flexibility relative to the previous proposal by providing
that a facility can take into account the nature of a preventive
control in determining when and how to establish and implement
appropriate preventive control management components,
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including monitoring, corrections or corrective actions, verification,
and records. Table 6 in the document provides examples of flexibility
provided by the rule, including flexibility provided for a facility to
take into account the nature of the preventive control when determining
the appropriate preventive control management components.
The potential product testing provisions would, if included in a
final rule, require that a facility conduct product testing as an
activity for verification of implementation and effectiveness as
appropriate to the facility, the animal food, and the nature of the
preventive control. The facility would be required to have written
procedures for product testing, corrective action procedures to address
the presence of a pathogen or appropriate indicator organism in
finished animal food detected as a result of product testing, and
records of product testing.
The potential environmental monitoring provisions would, if
included in a final rule, require that a facility conduct environmental
monitoring as an activity for verification of implementation and
effectiveness as appropriate to the facility, the animal food, and the
nature of the preventive control if contamination of finished animal
food with an environmental pathogen is a significant hazard. The
facility would be required to have written procedures for environmental
monitoring, corrective action procedures to address the presence of an
environmental pathogen or appropriate indicator organism detected
through the environmental monitoring, and records of environmental
monitoring.
The potential supplier program would, if included in a final rule,
require supplier controls when the facility's hazard analysis
identifies a significant hazard for a raw material or ingredient, and
that hazard is controlled before the facility receives the raw material
or ingredient (e.g., if a supplier tests a mineral mix for dioxin that
a facility would use to manufacture finished cattle feed). A facility
would not need to establish supplier controls if it controls that
hazard, or if its customer controls that hazard. The supplier program
would be written. With one exception, the receiving facility would have
flexibility to determine the appropriate verification activity (e.g.,
onsite audit; sampling and testing of the raw material or ingredient;
review of the supplier's food safety records; or other appropriate
verification activity). The exception would be when there is a
reasonable probability that exposure to the hazard will result in
serious adverse health consequences or death to humans or animals. In
this circumstance, the receiving facility would be required to have
documentation of an onsite audit of the supplier before using the raw
material or ingredient from the supplier and at least annually
thereafter, unless the receiving facility determines and documents that
other verification activities and/or less frequent onsite auditing of
the supplier provide adequate assurance that the hazards are
controlled. Instead of an onsite audit, a receiving facility may rely
on the results of an inspection of the supplier by FDA or, for a
foreign supplier, by FDA or the food safety authority of a country
whose food safety system FDA has officially recognized as comparable or
has determined to be equivalent to that of the United States, provided
that the inspection was conducted within 1 year of the date that the
onsite audit would have been required to be conducted.
The proposed requirements regarding potential hazards that may be
intentionally introduced for economic reasons would, if included in a
final rule, require that a facility consider in its hazard analysis
hazards that may be intentionally introduced for purposes of economic
gain.
We seek comment on whether these potential requirements discussed
above should be included in a final rule.
The previously proposed requirements provided for an exemption for
certain facilities defined by FSMA as ``qualified facilities.'' As
required by FSMA, the previously proposed requirements also included an
administrative procedure whereby we could withdraw that exemption under
certain circumstances. In this document, we are proposing a series of
modifications to the proposed withdrawal provisions. These
modifications include describing the steps we would take before
withdrawing an exemption, including advance notification to the
facility; a procedure for re-instatement of a withdrawn exemption; and
an additional 60 days for a facility whose exemption is withdrawn to
comply with the full requirements for hazard analysis and risk-based
preventive controls.
Costs and Benefits
We summarize the domestic annualized costs of the proposed
regulation with the revised provisions, including the potential
requirements for product testing, environmental monitoring, a supplier
program, and potential requirements regarding hazards that may be
intentionally introduced for economic reasons, using a discount rate of
7 percent and discounted over a 10 year period in the following table.
The revised proposed regulation uses a very small business definition
of less than $2,500,000 of total annual sales of animal food, adjusted
for inflation, and includes potential additional requirements that
facilities subject to subpart C institute risk-based environmental
monitoring, product testing, and a supplier program as appropriate to
the animal food, the facility and the nature of the preventive
controls, and controls to help prevent hazards associated with
economically motivated adulteration. As described in the updated
Preliminary Regulatory Impact Analysis (PRIA), for the final rule we
anticipate making several modifications to our estimate of the cost of
our proposed rule (Ref. 1) (see section XVIII). As with the original
proposal, we lack sufficient data to quantify the potential benefits of
this supplemental notice of proposed rulemaking.
A summary of the domestic costs and potential benefits of the
original and supplemental proposed rules is shown in the following
table.
Original and Revised Estimated Total Domestic Costs Based on Additional
Provisions
[Very Small Business Defined as Annual Animal Food Sales < $2.5 million]
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Total
(million)
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Original Total Annualized Costs without additional $65
provisions................................................
Additional costs because of potential new provisions....... 4
Revised Total Annualized Costs............................. 69
Benefits................................................... (\1\)
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\1\ Unquantified.
If foreign facilities are included, the total annualized cost of
this supplemental notice of proposed rulemaking is estimated at $93
million.
I. Background
A. Introduction
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353),
signed into law by President Obama on January 4, 2011, enables us to
better protect public (human and animal) health by helping to ensure
the safety and security of the food supply. FSMA enables us to focus
more on preventing food safety problems rather than relying primarily
on reacting to problems after they occur. The law also provides us with
new enforcement authorities to help achieve higher rates of compliance
with risk-
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based, prevention-oriented safety standards and to better respond to
and contain problems when they do occur. In addition, the law gives us
important new tools to better ensure the safety of imported foods and
encourages us to form partnerships with State, local, tribal, and
territorial authorities. Table 1 identifies three additional proposed
rules, issued to implement FSMA, that we discuss in this document.
Table 1--Published Proposed Rules for Implementation of FSMA
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Title Abbreviation Publication
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Current Good Manufacturing Practice 2013 proposed rule for 78 FR 64736, October 29, 2013.
and Hazard Analysis and Risk-Based preventive controls
Preventive Controls for Food for for food for animals.
Animals.
Current Good Manufacturing Practice 2013 proposed rule for 78 FR 3646, January 16, 2013.
and Hazard Analysis and Risk-Based preventive controls
Preventive Controls for Human Food. for human food.
Standards for the Growing, 2013 proposed rule for 78 FR 3504, January 16, 2013.
Harvesting, Packing, and Holding of produce safety.
Produce for Human Consumption.
Foreign Supplier Verification 2013 proposed rule for 78 FR 45730, July 29, 2013.
Programs (FSVP) for Importers of FSVP.
Food for Humans and Animals.
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B. 2013 Proposed Rule for Preventive Controls for Food for Animals
In the 2013 proposed rule for preventive controls, we:
Proposed to add, in newly established part 507,
regulations for Current Good Manufacturing Practice In Manufacturing,
Processing, Packing, and Holding for Food for Animals (CGMPs);
Proposed to add, in newly established part 507,
requirements for domestic and foreign facilities that are required to
register under section 415 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 350d) to establish and implement hazard
analysis and risk-based preventive controls for food for animals;
Requested comment on when and how product testing
programs, environmental monitoring programs, and supplier approval and
verification are an appropriate means of implementing the statutory
framework of FSMA; and
Requested comment on whether a final rule should address
potential hazards that may be intentionally introduced for economic
reasons.
We proposed to establish the requirements for CGMPs, for hazard
analysis and risk-based preventive controls, and related requirements
in new part 507 as shown in Table 2:
Table 2--Proposed Subparts in New Part 507
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Subpart Title
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A................................ General Provisions.
B................................ Current Good Manufacturing Practice.
C................................ Hazard Analysis and Risk-Based
Preventive Controls.
D................................ Withdrawal of an Exemption Applicable
to a Qualified Facility.
E................................ Reserved.
F................................ Requirements Applying to Records That
Must be Established and Maintained.
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In the 2013 proposed rule for preventive controls, we provided
background discussing:
The provisions of FSMA most directly applicable to the
proposed requirements, particularly the statutory provisions of section
103 of FSMA (established in section 418 of the FD&C Act);
Hazard Analysis and Critical Control Points (HACCP)
Systems;
Food Safety Problems Associated With Manufacturing,
Processing, Packing, and Holding Food for Animal Consumption;
The Role of Testing as a Verification Measure in a Food
Safety System (including discussions about environmental monitoring as
well as testing raw materials, ingredients, and finished product),
largely in an Appendix to the 2013 proposed rule for preventive
controls (the Appendix)); and
The Role of Supplier Approval and Verification Programs in
a Food Safety System (largely in the Appendix).
We also issued for public comment a ``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 risk assessment) (78 FR 64428, October 29, 2013). The
purpose of the draft risk assessment was to provide a science-based
risk analysis of those activity/animal food combinations that would be
considered low risk, when conducted in a facility co-located on a farm.
We used the tentative conclusions of the draft risk assessment 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 from the
requirements for hazard analysis and risk-based preventive controls.
II. Public Comments
A. Opportunities for Public Comment
We requested comments on the 2013 proposed rule for preventive
controls by February 26, 2014. We extended the comment periods for the
2013 proposed rule for preventive controls, its information collection
provisions, and the draft risk assessment in response to several
requests that we do so (see Table 3).
Since issuing the 2013 proposed rule for preventive controls, we
conducted numerous outreach activities. Three public meetings were held
to solicit oral stakeholder and public comments on the 2013 proposed
rule for preventive controls, inform the public about the rulemaking
process (including how to submit comments, data, and other information
to the rulemaking dockets), and respond to questions about the 2013
proposed rule for preventive controls (see Table 3) (Ref. 2, Ref. 3,
Ref. 4).
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Table 3--List of Federal Register Publications Regarding the 2013
Proposed Rule for Preventive Controls
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Description Publication
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2013 proposed rule for 78 FR 64736, October 29, 2013.
preventive controls,
requesting comments by
February 26, 2014.
Notice of availability of the 78 FR 64428 , October 29, 2013.
draft risk assessment,
requesting comments by
February 26, 2014.
Notice of public meetings (to 78 FR 64425, October 29, 2013.
be held in College Park, MD
on November 21, 2013; in
Chicago, IL on November 25,
2013; and, in Sacramento, CA
on December 6, 2013) on the
2013 proposed rule for
preventive controls.
Notice extending comment 79 FR 6111, February 3, 2014.
period, until March 31, 2014
, for the 2013 proposed rule
for preventive controls and
its information collections
provisions.
Notice extending comment 79 FR 6116 , February 3, 2014.
period, until March 31, 2014
, for the draft risk
assessment.
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B. Overview of Public Comments on the 2013 Proposed Rule for Preventive
Controls
We received more than 2100 submissions by the close of the comment
period, each containing one or more comments. Submissions were received
from diverse members of the public, including in part, human and animal
food facilities; trade organizations; consulting firms; law firms; pet
owners; consumers; consumer groups; Congress, Federal, State, local and
tribal Government Agencies. Some submissions included signatures and
statements from multiple individuals.
Comments address many provisions of the 2013 proposed rule for
preventive controls, including our requests for comment on including
additional provisions that we did not include in the proposed
regulatory text. Comments from some pet owners for the most part
indicated they were pleased that new requirements were being
established for the manufacture of pet food and that these requirements
were comparable to the requirements for human food, which were covered
by the 2013 proposed rule for preventive controls for human food. Some
comments questioned whether the proposed requirements reflected the
reality of production of food for animals with a particular concern
that the proposed risk-based approach focuses too heavily on pathogens
and not enough on other potential hazards in food for animals. Some
comments assert that additional public comment would be warranted
before any consideration on whether a final rule should or should not
include provisions discussed in the proposed rule, but for which we had
not included proposed regulatory text, such as potential requirements
for product testing, environmental monitoring, a supplier approval and
verification program, and potential hazards that may be intentionally
introduced for economic reasons. The comment period did not close until
March 31, 2014; we are still actively reviewing the comments.
C. Our Decision To Issue a Supplemental Notice of Proposed Rulemaking
for Public Comment
In December 2013, we announced that we would propose revised rule
language for key provisions of the 2013 proposed rule for preventive
controls for human food. Because the 2013 proposed rule for preventive
controls for food for animals is a companion rule to the proposed rule
on human food, in March 2014, we announced our intent to publish
revised language for the 2013 proposed rule for preventive controls for
food for animals, as well (Ref. 5). Elsewhere in this issue of the
Federal Register, we are issuing a supplemental notice of proposed
rulemaking to the 2013 proposed rule for preventive controls for human
food. Many of the proposed provisions of the animal food preventive
controls rule match those in the human food rule. Section IX and X
discuss our reasons for changes to the proposed current good
manufacturing practice regulations. Additional information regarding
the basis of this supplemental notice of proposed rulemaking can be
found in the supplemental notice of proposed rulemaking for preventive
controls for human food.
III. Scope of the Supplemental Notice of Proposed Rulemaking and Our
Request for Public Comment
In this document, we are proposing:
Revisions to several definitions we proposed to apply to
the requirements for hazard analysis and risk-based preventive
controls, including definitions for ``environmental pathogen,''
``reasonably foreseeable hazard,'' and ``very small business'';
New definitions for ``significant hazard'' ``pathogen,''
and ``you'';
Revisions to subpart B for current good manufacturing
practice regulations to make the requirements more applicable for
animal food facilities;
To not subject human food by-products used for animal food
by human food facilities that are subject to and in compliance with
subpart B of proposed part 117 and other applicable human food safety
requirements of the FD&C Act (and implementing regulations) for the
human food if the by-products are not further processed at the facility
to hazard analysis and preventive controls requirements and only
require compliance for holding and distributing these by-products;
Revisions to the proposed procedures that would govern
withdrawal of an exemption from a ``qualified facility,'' including
clarifications about the steps we would take before issuing an order to
withdraw the exemption, an expanded timeframe for a facility to comply
with an order withdrawing an exemption, and a mechanism for a withdrawn
exemption to be re-instated;
A series of revisions to the proposed requirements for
hazard analysis and risk-based preventive controls (proposed subpart C)
to:
Emphasize the risk-based nature of the preventive controls
and requirements for monitoring, corrective actions, and verification
activities;
Reduce the potential for misinterpretation that the rule
requires that all necessary preventive controls be established at
critical control points (CCPs) for all hazards that a facility
addresses in its food safety plan;
Change the wording in the ``Monitoring'' section to more
closely match the language of the statute and the proposed rule for
preventive controls for human food;
Increase flexibility for a facility to determine, based on
the nature of a preventive control, when requirements for ``preventive
control management components'' (i.e., monitoring, corrective actions,
and verification) are appropriate;
Substitute the pronoun ``you'' for ``the owner, operator,
or agent in charge of the facility'' throughout these proposed
requirements;
Substitute the term ``adequate'' (which is a term we
proposed to define) in place of the term ``sufficient'' (which we did
not propose to define);
[[Page 58481]]
Improve readability, through rearrangement of some of the
proposed regulatory text and editorial revisions (such as increased use
of active voice).
In this document, we also are providing an opportunity for public
comment on potential requirements for product testing, environmental
monitoring, a supplier program, and hazards that may be intentionally
introduced for purposes of economic gain, including definitions of
terms (i.e., ``qualified auditor,'' ``receiving facility,'' and
``supplier'') that would be used in some of those potential
requirements. We are seeking comment on whether such requirements
should be included in a final rule and, if so, what (if any)
modifications to the proposed regulatory text would be appropriate.
We discuss these proposed requirements in sections V through XVI.
Because several of the proposed revisions relate to the overall
framework in subpart C for hazard analysis and risk-based preventive
controls, we are including the complete regulatory text for proposed
subpart C. However, in this document, we are reopening the comment
period only with respect to the issues specified in this section III.
Importantly, the proposed revisions to the provisions we have
included in the regulatory text are based on preliminary review of
comments. We will complete our review of comments previously submitted
and consider the comments responsive to this Legal and Regulatory
Framework Under of proposed rulemaking in developing the final rule.
IV. Legal and Regulatory Framework Under Sections 415 and 418 of the
FD&C Act and Regulations Implementing Section 415 of the FD&C Act
In the 2013 proposed rule for preventive controls for human food
(78 FR 3646), we described the current legal and regulatory framework
that governs the determination of when an establishment is required to
register as a food facility in accordance with the section 415
registration regulations (21 CFR part 1, subpart H; the section 415
registration regulations). We focused on the framework that governs
whether an establishment that grows and harvests crops satisfies the
definition of ``farm'' because the facility registration requirements
of section 415 of the FD&C Act do not apply to ``farms.'' When we
implemented the statutory requirements for registration of food
facilities, it established a definition for ``farm'' that first
describes a farm as a facility devoted to the growing and harvesting of
crops, the raising of animals (including seafood), or both (Sec.
1.227; 68 FR 58894, October 10, 2003). Although that definition of
``farm'' then provides that farms also pack or hold food, it limits
facilities that fall within the definition of ``farm'' to those that
pack or hold food grown, raised, or consumed on that farm or another
farm under the same ownership. Thus, under the current framework an
establishment that is devoted to the growing and harvesting of crops,
but also packs and holds food not grown or raised on that farm or on
another farm under the same ownership, would fall outside the
definition of ``farm'' and be required to register as a food facility.
Because an establishment that is required to register as a food
facility is subject to the requirements of section 418 of the FD&C Act,
under the current framework a determination of whether an establishment
devoted to the growing and harvesting of crops is subject to FSMA's
requirements for hazard analysis and risk-based preventive controls
depends, in part, on where the food that the establishment packs or
holds is grown or raised.
Under the current framework, a key factor in whether an
establishment falls within the definition of ``farm,'' even with
respect to crops it grows and harvests itself, is whether the
activities conducted by the farm fall within definitions of
``harvesting,'' ``packing'' or ``holding'' (which are within the
``farm'' definition). As discussed in the 2013 proposed rule for
preventive controls for human food, section 103 of FSMA directs FDA to
conduct rulemaking to clarify the on-farm manufacturing, processing,
packing and holding activities that would trigger a requirement for a
farm to register as a food facility and, thus, be subject to the
requirements for hazard analysis and risk-based preventive controls (78
FR 3646 at 3674). In the 2013 proposed rule for preventive controls for
human food, we explained how the status of a food as a raw agricultural
commodity (RAC) or a processed food affects the requirements applicable
to a farm under sections 415 and 418 of the FD&C Act. For further
discussion see section IV of the preamble in the supplemental notice of
proposed rulemaking for preventive controls for human food, published
elsewhere in this Federal Register.
In sections V and VI, we discuss the proposed revised definitions
for ``farm,'' ``harvesting,'' ``packing,'' and ``holding.''
V. The ``Farm'' Definition
We are reopening the comment period, in the supplemental notice of
proposed rulemaking for preventive controls for human food published
elsewhere in this issue of the Federal Register, with respect to
``Farm,'' ``Harvesting,'' ``Holding,'' and ``Packing''.
A. 2013 Proposed Definitions of ``Farm,'' ``Harvesting,'' ``Holding,''
and ``Packing''
Consistent with the organizing principles regarding classification
of activities on-farm and off-farm, in the proposed rule for preventive
controls for human food (78 FR 3646), we proposed to define
``harvesting,'' as a new definition in Sec. Sec. 1.227 and 1.328, to
apply to farms and farm mixed-type facilities and to mean activities
that are traditionally performed by farms for the purpose of removing
RACs from the place they were grown or raised and preparing them for
use as food. We proposed that harvesting be limited to activities
performed on the farm on which they were grown or raised, or another
farm under the same ownership, and that harvesting does not include
activities that transform a RAC into a processed food. The proposed
definition included examples of activities that would be harvesting. As
a conforming change to the proposed definition of ``harvesting,'' we
proposed, to revise the definition of ``farm'' in current Sec. Sec.
1.227(b)(3) and 1.328 to delete examples of harvesting that currently
appear in the ``farm'' definition.
We also proposed, in the preventive controls proposed rule for
human food, to revise the definition of ``holding'' in Sec. Sec. 1.227
and 1.328 so that it would be a two-part definition that would include,
for farms and farm mixed-type facilities, activities traditionally
performed by farms for the safe or effective storage of RACs grown or
raised on the same farm or another farm under the same ownership, but
would not include activities that transform a RAC into a processed
food.
We proposed, in the preventive controls proposed rule for human
food, to revise the definition of ``packing'' in Sec. Sec. 1.227 and
1.328 so that it would be a two-part definition that would include, for
farms and farm mixed-type facilities, activities (which may include
packaging) traditionally performed by farms to prepare RACs grown or
raised on a farm or another farm under the same ownership for storage
and transport, but would not include activities that transform a RAC
into a processed food.
See section V in the supplemental notice of proposed rulemaking for
preventive controls for human food, published elsewhere in this Federal
Register for additional discussion RACs.
[[Page 58482]]
B. Proposed Revisions to the Proposed Definitions of ``Farm,''
``Harvesting,'' ``Holding,'' and ``Packing''
In the supplemental notice of proposed rulemaking for preventive
controls for human food, published elsewhere in this Federal Register,
we are proposing to revise the ``farm'' definition so that it would no
longer limit establishments that fall within the ``farm'' definition to
those that pack or hold food grown, raised, or consumed on that farm or
another farm under the same ownership. Under the revised ``farm''
definition, an establishment devoted to the growing of crops, the
raising of animals, or both, would remain within the ``farm''
definition (and, thus, not be subject to the section 415 registration
regulations and the proposed requirements for hazard analysis and risk-
based preventive controls) even if it packs and holds raw agricultural
commodities grown on another farm. To limit the potential for confusion
related to the term ``facility,'' we are proposing to substitute the
term ``establishment'' for the term ``facility'' in the revised
definition of ``farm.'' We also are proposing that the packing
activities (which may include packaging) that it had proposed to
include in the expanded definition of ``packing'' for farms and farm
mixed-type facilities be included in the ``farm'' definition rather
than in an expanded definition of ``packing.'' Under the revised
``farm'' definition, it will be clear that an establishment devoted to
the growing of crops, the raising of animals, or both, can remain
within the ``farm'' definition if it packages RACs grown or raised on a
farm to prepare them for storage and transport, without additional
manufacturing/processing. The proposed revised definition of
``harvesting'' would also include ``field coring'' as an example of a
harvesting activity to make clear that on farm ``field coring'' of a
RAC (e.g., removing the core of lettuce in the field at the same time
the stem is cut and wrapper leaves removed) is a harvesting activity,
even though ``coring'' outside of ``field coring'' (e.g., during the
production of fresh-cut lettuce) is a manufacturing/processing
activity.
For further discussion, please see section V in the supplemental
notice of proposed rulemaking for preventive controls for human food
published elsewhere in this issue of the Federal Register.
C. One General Physical Location
We received some comments on the 2013 proposed rule for preventive
controls for human food stating that that farms throughout the country
are now made up of multiple, often non-contiguous fields due to
geographic and topographic conditions, local development patterns, and
the fact that a single ``farm'' today often derives from multiple
previous farms due to the need to achieve economic efficiencies. Some
comments explain that as farm land increasingly is partitioned into
smaller and smaller parcels through estate divisions or for other
reasons, farmers purchasing land find that they are rarely able to
purchase adjacent parcels. These comments ask us to modify or remove
the phrase ``in one general location'' in the ``farm'' definition.
During the rulemaking to establish the ``farm'' definition in the
section 415 registration regulations, we explained that a farm may
consist of contiguous parcels of land, ponds located on contiguous
parcels of land, or, in the case of netted or penned areas located in
large bodies of water, contiguous nets or pens (68 FR 5378 at 5381,
February 3, 2003). However, we did not propose to include this
explanatory sentence in the regulatory text. Comments addressing ``one
general physical location'' focused on how specifying ``in one general
physical location'' would affect whether the farm would be subject to
the section 415 registration regulations. Our response to those
comments focused on the nature of the activities being conducted rather
than on the contiguous or non-contiguous nature of parcels of land or
nets (68 FR 58894 at 58906, October 10, 2003).
The definition of ``facility'' in the section 415 registration
regulations likewise specifies that a facility means ``any
establishment, structure, or structures under one ownership at one
general physical location . . .'' However, this definition specifically
adds an explanatory statement that a facility may consist of one or
more contiguous structures (Sec. 1.227). During the rulemaking to
establish this definition of ``facility,'' we explained that we
proposed to include this explanatory sentence in the regulatory text as
a result of comments that we received during our early outreach efforts
(68 FR 5378 at 5381, February 3, 2003).
We are requesting comment on whether we should retain, remove, or
modify the phrase ``in one general physical location'' in the ``farm''
definition. Elsewhere in this issue of the Federal Register, in the
supplemental notice of proposed rulemaking for preventive controls for
human food, we are also requesting comment on the phrase ``in one
general physical location'' in the ``farm'' definition. In responding
to our request for comment on this issue, we ask commenters to
carefully consider what, if any, impacts removing or modifying this
phrase could have on other rules that already include (or have proposed
to include) the same definition of ``farm'' as would be established in
the section 415 registration regulations, as well as how such impacts
would best be addressed. Please see section V.E in the supplemental
notice of proposed rulemaking for preventive controls for human food
published elsewhere in this issue of the Federal Register for further
discussion on this issue.
D. Feed Mills Associated With Contract and Fully Vertically Integrated
Farming
We received some comments requesting clarification of whether all
feed mills associated with contract farming or fully vertically
integrated farming models would be required to comply with the proposed
rule.
We are aware that there are a variety of farming models for raising
animals. In one model, often referred to as contract farming, one
entity owns the feed mill and the animals, but contracts with another
entity that owns the establishment devoted to raising the animals. In
this model, the feed mill would not be considered part of a farm under
the current definition in 21 CFR 1.227 (see 68 FR 58894 at 58907 (Oct.
10, 2003) and 68 FR 5378 at 5382 (Feb. 3, 2003)). The feed mill also
would not be considered part of a farm under the proposed revised
definition of farm in the supplemental notice of proposed rulemaking
for preventive controls for human food published elsewhere in this
issue of the Federal Register. Therefore, the feed mill would be
required to register as a food facility under section 415 of the FD&C
Act and would be subject to the proposed rule for preventive controls.
In a second model, often referred to as fully vertically integrated
farming, one entity owns the feed mill, the animals, and the
establishment devoted to raising the animals. In this model, the feed
mill would be considered part of a farm under the current definition in
21 CFR 1.227 (68 FR 58894 at 58907), and the proposed revised
definition. Therefore, the feed mill would be exempt from registering
as a food facility under section 415 of the FD&C Act and would not be
subject to the proposed rule for preventive controls rule.
Cooperative farming is another model and depending on how the
cooperative is structured, it can resemble the contract model or the
fully vertically integrated model. How the cooperative is structured
determines whether the
[[Page 58483]]
feed mill is required to register as a food facility under section 415
of the FD&C Act.
We have no evidence that the safety of animal food varies depending
on whether a feed mill is associated with vertically integrated or
contract farming. Therefore, we are asking for comment on whether feed
mills associated with fully vertically integrated farming operations,
including cooperatives that fit this model, that meet the farm
definition (current or proposed revision) should be required to
register as a food facility under section 415 of the FD&C Act. If so,
how should we revise the farm definition so the feed mills associated
with these fully vertically integrated farming operations would not be
considered farms, would be required to register under section 415, and
thus would be subject to the proposed rule. Registration under section
415 of the FD&C Act would also subject these feed mills to additional
statutory requirements under the FD&C Act, for example, recordkeeping
requirements under section 414, requirements for the Reportable Food
Registry under section 417, and requirements for mandatory recall under
section 423.
If these fully vertical farming feed mills would be required to
register under section 415 of the FD&C Act, we also request comment on
whether there should be an exemption from registration under section
415 for some of these feed mills based on size, such as number of
animals being fed or the amount of animal food being fed (based on
tonnage, monetary value, or some other factor).
Under the fully integrated vertical farming operations and certain
contract farming operations, there would be no total annual sales
figure for the animal food that could be used to determine whether a
facility is a qualified facility (and thus exempt from proposed subpart
C). With regard to these feed mills, we request comment on how to value
the animal food being fed to animals for purposes of determining
whether the feed mill would be a qualified facility (proposed Sec.
507.7) and in particular a very small business. Qualified facilities
would be exempt from the requirements of subpart C (hazard analysis and
risk-based preventive controls).
VI. Definitions of ``Holding'' and ``Packing''
A. 2013 Proposed Definition of ``Holding''
In the 2013 proposed rule for preventive controls for human food,
we proposed to revise the definition of ``holding'' in Sec. Sec. 1.227
and 1.328 (see section V.A).
B. 2013 Proposed Exemptions Relevant to the Definition of ``Holding''
We proposed two exemptions directed to facilities ``solely
engaged'' in the storage (i.e., holding) of certain types of animal
food, and explained our reasons for doing so.
First, we proposed to exempt facilities that are solely engaged in
the storage of RACs (other than fruits and vegetables) intended for
further distribution or processing from the requirements for hazard
analysis and risk-based preventive controls, and explained our reasons
for proposing to do so (proposed Sec. 507.5(g); see discussion at 78
FR 64736 at 64764). We intended this provision to exempt, for example,
facilities that only store whole grains (such as corn, wheat, barley,
rye, grain sorghum, oats, rice, wild rice, and soybeans) from the
requirements for hazard analysis and risk-based preventive controls,
provided that such facilities do not conduct other activities subject
to FSMA's requirements for hazard analysis and risk-based preventive
controls (78 FR 64736 at 64764).
Second, we proposed to exempt a ``facility solely engaged in the
storage of packaged food for animals that is not exposed to the
environment'' from the requirements for hazard analysis and risk-based
preventive controls that would be established in subpart C (proposed
Sec. 507.10(a); see discussion at 78 FR 64736 at 64768). We intended
this provision to exempt, for example, facilities that store packaged
animal food in containers in a warehouse. However, a facility solely
engaged in the storage of packaged animal food that is not exposed to
the environment and that requires time/temperature control to
significantly minimize or prevent the growth of, or toxin production
by, pathogens would be subject to modified requirements (see proposed
Sec. Sec. 507.10(b) and 507.51.
In this section of this document, we are proposing revisions to the
definition of ``holding'' in addition to the revisions, discussed in
section V.B, that would be conforming amendments in light of the
revised ``farm'' definition. In this section of this document, we are
reopening the comment period with respect to the revised definition of
``holding'' (proposed Sec. 507.3).
C. Comments on the 2013 Proposed Exemption for a Facility Solely
Engaged in the Storage of RACs (Other Than Fruits and Vegetables)
Intended for Further Distribution or Processing
Some comments support for the proposed exemption for a facility
solely engaged in the storage of RACs (other than fruits and
vegetables) intended for further distribution or processing. However,
some stakeholders expressed concern, during outreach activities such as
the public meetings and in written comments, that the proposed
definition of ``holding'' would preclude facilities such as grain
elevators from being eligible for the exemption in proposed Sec.
507.5(g) because most such facilities conduct a variety of activities
in addition to ``storage.'' For example, grain elevators typically
conduct the following activities that could be characterized as being
practical necessities, either for the purposes of safe or effective
storage or for meeting customer specifications:
Fumigate grain to control pest infestation during storage;
Clean grain using various mechanisms (sifting, sieving,
and screening);
Convey grain throughout the facility;
Dry grain received with high moisture content; and
Blend lots of grain.
Some comments recommended that we modify the proposed definition
for ``holding'' to (1) encompass activities performed for the safe or
effective storage of RACs (such as drying, screening, conditioning, and
fumigating) off-farm and (2) encompass activities performed on RACs as
a practical necessity for product distribution (such as blending
different lots of the same commodity to meet a customer's quality
specifications).
D. Comments on the 2013 Proposed Exemption for a Facility Solely
Engaged in the Storage of Packaged Food That Is Not Exposed to the
Environment
Some comments received during the public meetings for the 2013
proposed rule for preventive controls for animal food and received
under the 2013 proposed rule for preventive controls for human food
support the proposed exemption for a facility ``solely engaged in the
storage of packaged food that is not exposed to the environment.''
These comments note that warehouses typically conduct the following
activities that could be characterized as being practical necessities,
either for the purposes of storage or for product distribution,
including:
[[Page 58484]]
Affix tracking labels;
Transport to a storage location in the warehouse;
Hold non-food products, including toys and grooming aids
for pets;
Break down pallets of packaged animal food for
distribution to the retail level in less-than-pallet quantities;
Assemble ``sales kits'' for use in fundraising drives;
Assemble variety packs by packing; and
Use packaged food to build store displays.
Some of these comments we received recommend that we modify the
proposed definition for ``holding'' to encompass activities that are
performed on packaged food that is not exposed to the environment (1)
incidental to storage of the animal food (such as transport and storage
of non-animal food products); and (2) as a practical necessity for
product distribution (such as affixing tracking labels, breaking down
pallets, assembling sales kits and variety packs, and building store
displays).
E. Proposed Revisions to the Definition of ``Holding''
Taking into account the comments we have reviewed so far for the
2013 proposed rules for preventive controls, we tentatively conclude
that we should revise the definition of ``holding'' to encompass
activities performed incidental to storage of animal food (e.g.,
activities performed for the safe or effective storage of that animal
food and activities performed as a practical necessity for the
distribution of that animal food). In addition to the activities
specifically identified in the comments, we are aware of other
activities (Ref. 6) that can be considered incidental to storage of
RACs, either for the purposes of safe or effective storage or for
meeting customer specifications, including:
Treating stored grain with protectant chemicals and
pesticide alternatives (other than by fumigation) to control
infestation;
Using modified atmosphere treatments to control pests;
Using biological controls for pests;
Applying chemical preservatives to grain to prevent growth
of mycotoxin-producing molds;
Weighing grain;
Sampling and grading grain; and
Aerating grain to control temperature.
In this document, we are proposing to revise the definition of
holding to:
Clarify that holding also includes activities performed
incidental to storage of an animal food (e.g., activities performed for
the safe or effective storage of that animal food and activities
performed as a practical necessity for the distribution of that animal
food (such as blending of the same commodity));
Broaden ``activities . . . performed for the safe or
effective storage of raw agricultural commodities'' to apply to all
animal food, not just RACs;
Broaden ``activities . . . performed for the safe or
effective storage'' to apply to all establishments that hold animal
food, not just farms and farm mixed-type activities;
Add ``breaking down pallets'' to the examples in the
revised definition of ``holding'' so that the examples reflect
activities conducted on packaged animal food as well as activities
conducted on RACs; and
Specify that holding facilities ``could'' include the
listed types of facilities to clarify that some of these facilities
might not meet the definition of a holding facility if they perform
other activities not included in the definition of holding (e.g., if a
grain elevator mixes different commodities to prepare animal food).
As discussed in section V.B, the revised definition of ``holding''
also would remove limitations on where the food is grown or raised (as
a conforming change to the revised definition of ``farm'' found in the
supplemental notice of proposed rulemaking for preventive controls for
human food, published elsewhere in this issue of the Federal Register.
The revised definition of ``holding'' would now be a one-part
definition that applies to all facilities that hold animal food, rather
than a two-part definition that first specifies activities that are
within the definition regardless of the type of establishment and then
specifies additional activities that would apply only to establishments
that are farms or farm mixed-type facilities.
With this revised definition of ``holding,'' facilities such as
grain elevators and silos would, in most cases, satisfy the criteria
for the proposed exemption for facilities solely engaged in the storage
of RACs (other than fruits and vegetables) intended for further
distribution or processing (proposed Sec. 507.5(g)), because the
definition would encompass activities performed as a practical
necessity for the distribution of RACs. Other facilities that conduct
operations similar to those conducted at grain elevators and silos,
such as facilities that package and sell seed for crops, but sell the
leftover seed for animal food, also may satisfy these criteria for
exemption.
With this revised definition of ``holding,'' facilities such as
warehouses would, in many cases, satisfy the criteria for the proposed
exemption for facilities solely engaged in the storage of packaged
animal food that is not exposed to the environment (proposed Sec.
507.10(a)), because the definition would encompass activities that are
a practical necessity for product distribution (such as breaking down
pallets and affixing tracking labels). We are adding ``breaking down
pallets'' to the examples in the revised definition of ``holding'' so
that the examples reflect activities conducted on packaged animal food
as well as activities conducted on RACs. Although we are not adding
more examples to reflect activities conducted on packaged animal food,
the revised definition of ``holding'' also would include activities
such as assembling sales kits and variety packs, because such
activities are similar to breaking down pallets except that the order
of activities is reversed.
F. Proposed Revisions to the Definition of ``Packing''
Just as there are some activities that are performed incidental to
storing food for animals, there are some activities that are performed
incidental to packing an animal food. For example, sorting, culling,
and grading RACs could be an activity incidental to packing on a farm
or farm mixed-type facility, whereas off-farm some sorting or similar
activities such as culling or grading may be required to ensure that
like items are packed together, or to remove damaged items. As another
example, animal food may need to be conveyed (moved) about an
establishment for the purpose of packing it, and may need to be weighed
to ensure that appropriate amounts are packed. We tentatively conclude
that we should revise the definition of ``packing'' so that it includes
activities performed incidental to packing food for animals. In this
document, we are proposing to revise the definition of packing to:
Clarify that packing also includes activities performed
incidental to packing animal food (e.g., activities performed for the
safe or effective packing of that animal food (such as sorting, culling
and grading));
Provide that activities performed incidental to packing an
animal food would apply to all establishments that pack animal food,
not just to farms and farm mixed-type facilities; and
Delete the provision, in the 2013 proposed rule for
preventive controls, that packing would include activities (which may
include packaging) traditionally performed on a farm on
[[Page 58485]]
RACs grown on a farm for storage or transport, because this issue would
be addressed in the revised ``farm'' definition in the supplemental
notice of proposed rulemaking for preventive controls for human food,
published elsewhere in this Federal Register.
VII. Impact of the Proposed Revisions to the Farm-Related Definitions
on the Classification of On-Farm Activities
A. Comments on the 2013 Organizing Principles for Classifying
Activities Conducted on Farms and on Farm Mixed-Type Facilities
See the supplemental notice of proposed rulemaking for preventive
controls for human food, published elsewhere in this Federal Register,
for discussion of comments.
B. Updated Organizing Principles That Would Apply to the ``Farm''
Definition
We articulated the 2013 organizing principles for classifying on-
farm activities to operate within the framework, already established in
the section 415 registration regulations, in which an establishment
that packs and holds others' RACs would be outside the ``farm''
definition and, thus, be required to register as a food facility. Our
proposed revisions to the ``farm'' definition, found in the
supplemental notice of proposed rulemaking for preventive controls for
human food, published elsewhere in this Federal Register, would change
that framework and, as a consequence, require that we reconsider those
organizing principles.
Organizing Principles Nos. 1, 3, and 5 remain consistent with the
proposed revisions to the ``farm'' definition. However, there would be
no need to specify, in Organizing Principle No. 2, that activities that
farms traditionally do relate only to their own RACs. In addition,
Organizing Principle No. 4 would no longer apply, because the revised
``farm'' definition would no longer classify an activity as within (or
outside of) the ``farm'' definition based, in part, on whether an
activity is conducted on a farm's own RACs or on others' RACs.
Therefore, we tentatively conclude it is appropriate to delete
Organizing Principle No. 4 in light of the proposed revisions to the
``farm'' definition.
Table 4 shows our current thinking regarding the organizing
principles applicable to the revised ``farm'' definition.
Table 4--Updated Organizing Principles That Would Apply to the Revised
``Farm'' Definition
------------------------------------------------------------------------
No. Organizing principle
------------------------------------------------------------------------
1...................................... The basic purpose of farms is
to produce RACs, and RACs are
the essential products of
farms.
2...................................... Activities that involve RACs
and that farms traditionally
do for the purposes of growing
RACs, removing them from the
growing areas, and preparing
them for use as a food RAC,
and for packing, holding and
transporting them, should all
be within the definition of
``farm.''
3...................................... Activities should be classified
based in part on whether the
food operated on is a RAC or a
processed food, and on whether
the activity transforms a RAC
into a processed food.
4...................................... Manufacturing/processing,
packing, or holding food--
whether RACs or processed
foods, from any source--for
consumption on the farm should
remain within the farm
definition.
------------------------------------------------------------------------
C. Changes to Classification of On-Farm Activities
We reconsidered the classification of specific activities as
harvesting, packing, holding, or manufacturing/processing, when
conducted on farms or on farm mixed-type facilities. See the Appendix
to this document for a comprehensive table comparing the classification
of on-farm activities as harvesting, packing, holding, or
manufacturing/processing in the 2013 proposed rule for preventive
controls to our current thinking on the classification of these on-farm
activities. As can be seen in the Appendix, several on-farm activities
can be classified in more than one way, and most of the changes in
activity classification merely reflect additional activities (relative
to the 2013 proposed rule for preventive controls) that could be
classified in more than one way. For example, in the 2013 proposed rule
for preventive controls, we classified ``removing stems and husks'' as
a harvesting activity (e.g., if RACs are husked while they are being
removed from the field). In this supplemental notice of proposed
rulemaking, we also consider ``removing stems and husks'' to be a
packing activity (e.g., if RACs are husked after the RACs have been
removed from the field).
See Table 5 in this document for a list of the activity
classifications that would change in light of the proposed revisions to
the ``farm'' definition and our reconsideration of activity
classification. As shown in Table 5, changes in activity classification
as a result of the proposed revisions to the ``farm'' definition would
result in a single circumstance (drying/dehydrating RACs to create a
distinct commodity without additional manufacturing/processing) where a
farm conducting manufacturing/processing would no longer be required to
register as an animal food facility. Importantly, the revised ``farm''
definition would not result in any new circumstance where a farm would
now be required to register as a food facility.
Table 5 includes one activity (i.e., using pesticides on RACs as a
packing activity) that we did not address in the 2013 proposed rule for
preventive controls and excludes a number of activities (e.g., cooling
RACs and coating RACs with wax/oil/resin) that were classified in the
appendix of the draft risk assessment (Ref. 7) but are not performed on
animal food.
Table 5 includes one activity (i.e., drying/dehydrating (incidental
to holding)) that we now would classify in fewer ways than we did in
the 2013 proposed rule for preventive controls. In the 2013 proposed
rule for preventive controls, we classified drying/dehydrating (for
purposes of storage or transport, rather than to create a distinct
commodity) (e.g., drying alfalfa) as being either a packing activity or
a holding activity, depending on when the drying/dehydrating took
place. After reconsidering all of the activity classifications, we
tentatively conclude that such drying/dehydrating should continue to be
classified as ``holding,'' but does not constitute ``packing.'' We
request comment on this narrowed classification of drying/dehydrating
when the drying/dehydrating does not create a distinct commodity.
[[Page 58486]]
Table 5--Changes in Classification of Activities Conducted on Farms or on Farm Mixed-Type Facilities Based on
the Proposed Revisions to the ``Farm'' Definition
----------------------------------------------------------------------------------------------------------------
Why would the re-
classification
Classified in 2013 Classified in represent a change from
Activity proposed rule for supplemental notice of the 2013 proposed rule
preventive controls proposed rulemaking for preventive controls
for animal food? \2\
----------------------------------------------------------------------------------------------------------------
Cooling.............................. Harvesting; (Sec. Mfg/processing Acknowledge that field
507.3); Mfg \1\ / (e.g., cooling of cooling of animal food
Processing (Sec. processed animal food). RACs is not done.
507.3).
Drying/dehydrating (incidental to Packing or Holding Holding (e.g., Because we would no
holding). (Tables 1 and 15 of drying hay or alfalfa). longer consider drying/
the draft risk dehydrating to be a
assessment (RA)) (Ref. packing activity.
7).
Drying/dehydrating to create a Mfg/Processing (Table Mfg/processing Because we are
distinct commodity (transforms a RAC 15 of the draft RA) (e.g., drying grapes including this
into a processed animal food). (Ref. 7). to create raisins, and specific mfg/
drying herbs to create processing activity
a distinct commodity) within the ``farm''
(because it transforms definition, provided
a RAC into a processed that there is no
animal food) (but additional
allowed within the manufacturing/
farm definition). processing.
Filtering............................ Harvesting (Sec. Harvesting Acknowledge that
507.3). (e.g., filtering filtering is not done
honey). on animal food RACs.
Removing stems and husks............. Harvesting (Sec. Harvesting Acknowledge that
507.3). (e.g., in the field). removing stems/husks
Packing (e.g., can occur during more
in a packing shed). than harvesting
operations.
Sifting.............................. Harvesting (Sec. Harvesting Acknowledge that
507.3). (e.g., in the field). sifting can occur
Packing (e.g., during more than
in a packing shed). harvesting operations.
Using pesticides on RACs............. Harvesting (Tables 1 Harvesting Acknowledge that
and 15 of the draft RA (e.g., in the field). pesticides may be used
discussed only Packing (e.g., at various points in
fumigation ) (Ref. 7 ). in a packing shed). preparation of RACs
Washing.............................. Harvesting (Sec. Harvesting Acknowledge that field
507.3), and Mfg/ (e.g., washing in the washing of animal RACs
Processing (Sec. field was deleted). does not occur but
507.3). Mfg/processing washing during
(e.g., during processing may occur.
production of an
animal food).
----------------------------------------------------------------------------------------------------------------
\1\ Mfg = Manufacturing.
\2\ This table focuses on any change in classification in this document compared to the classification, in the
2013 proposed rule for preventive controls for food for animals, for activities conducted on a farm's own
RACs. The proposed revisions to the ``farm'' definition would make the distinction between whether a farm
conducted an activity on its own RACs or on others' RACs irrelevant.
VIII. Proposed Exemptions for On-Farm Low-Risk Activity/Animal Food
Combinations
A. The 2013 Proposed Exemptions
In the 2013 proposed rule, we described provisions of FSMA that
direct us to (1) conduct a science-based risk analysis to cover
specific types of on-farm packing, holding, and manufacturing/
processing activities that would be outside the ``farm'' definition
and, thus, subject to the requirements for hazard analysis and risk-
based preventive controls (78 FR 64736 at 64751 and 64752-64754); and
(2) consider the results of that science-based risk analysis and exempt
facilities that are small or very small businesses from these
requirements (or modify these requirements, as we determine
appropriate), if such facilities are engaged only in specific types of
activities that we determine to be low risk involving specific animal
foods that we determine to be low risk. Consistent with this statutory
direction, we developed the draft risk assessment and made it available
for public comment (Ref. 7 and 78 FR 64428); and proposed three
exemptions for on-farm activity/animal food combinations conducted by
farm-mixed-type facilities that are small or very small businesses
(proposed Sec. 507.5(e), (f)(1), and (f)(2)).
B. Comments on the Proposed Exemptions for On-Farm Low-Risk Activity/
Animal Food Combinations
Some comments received to the proposed rule for preventive controls
for human food (78 FR 3646) request clarification on whether an
establishment that conducts more than one activity/food combination
listed in the proposed exemptions for on-farm low-risk activity/food
combinations would be eligible for the exemption. Other comments
recommend including additional on-farm packing and holding activity/
food combinations, or on-farm manufacturing/processing activity/food
combinations, as low-risk activity/food combinations eligible for
inclusion in the proposed exemptions.
We are confirming that an establishment that conducts more than one
activity/animal food combination listed in the proposed exemptions for
on-farm low-risk activity/animal food combinations would be eligible
for the exemption. The regulatory text is written in the plural (e.g.,
``if the only packing and holding activities . . . that the business
conducts are the following low-risk packing or holding activity/animal
food combinations''; and ``if the only manufacturing/processing
activities . . . that the business conducts are the following'').
We have not fully completed our review of comments on the 2013
proposed rule for preventive controls and the draft risk assessment. It
is possible we may include additional activity/animal food combinations
in these exemptions when we issue the final rule.
C. Impact of the Proposed Revisions to the Definitions for ``Farm,''
``Harvesting,'' ``Holding,'' and ``Packing'' on the 2013 Proposed
Exemptions for On-Farm Low-Risk Activity/Animal Food Combinations
The proposed revisions to the definitions of ``farm,''
``harvesting,'' ``holding,'' and ``packing,'' if finalized, would have
three principal effects on the proposed exemptions.
First, the proposed exemption for on-farm packing or
holding of animal food by a small or very small business would no
longer identify any packing or holding activities for any RACs, because
an on-farm establishment would no longer be subject to the requirements
for hazard analysis and risk-based preventive controls when it packs or
holds RACs, regardless of whether it is packing and holding its own
RACs or others' RACs. The proposed exemption would continue to apply
on-farm packing and holding of processed animal foods (e.g., packing
and holding of silage when conducted by a farm mixed-type facility).
Second, the proposed exemption for on-farm low-risk
manufacturing/
[[Page 58487]]
processing activities conducted by a small or very small business would
no longer distinguish between manufacturing/processing activities
conducted on a farm mixed-type facility's own RACs and manufacturing/
processing activities conducted on animal food other than the farm
mixed-type facility's own RACs.
Third, the proposed exemption for on-farm low-risk
manufacturing/processing activities conducted by a small or very small
business would be revised to eliminate activities, conducted on others'
RACs, which would no longer be classified as manufacturing/processing
and instead would be classified as harvesting, packing, or holding. For
example, blending different lots of the same RACs such as whole grains
would remain within the ``farm'' definition, and not be considered
manufacturing/processing, regardless of whether the RACs being blended
are the farm's own RACs or others' RACs. However, mixing forage to make
silage would be considered manufacturing/processing and, thus, would
continue to be considered a low-risk manufacturing/processing activity
listed within the exemption for on-farm low-risk manufacturing/
processing activities conducted by a small or very small business.
We will update these proposed exemptions when we issue the final
rule, after considering comments, and reaching a decision in light of
those comments, on the proposed revisions to the definitions that
impact the proposed exemptions for low-risk activity/animal food
combinations.
IX. Proposed Applicability of Part 507 to the Holding and Distribution
of Human Food By-Products for Use in Animal Food
Historically, many facilities that manufacture/process or pack
human food also provide by-products from that human food production for
use as animal food (Ref. 8). These by-products are a significant source
of animal food or animal food ingredients. While these by-products may
not be nutritious, suitable, or desirable for human consumption, they
can be a source of energy and nutrition for certain species of animals,
many of which have different digestive systems, physiology, and
nutritional requirements than humans (e.g., ruminants such as cattle
and sheep). The differences enable these animals to digest and
metabolize the by-products in a way humans cannot.
Some of the by-products do not undergo further processing (such as
drying, grinding, pelleting, etc.) at the human food facility before
being used for animal food. Examples of these by-products include
culls, peels, trimmings, and pulp from fruit and vegetable
manufacturing/processing; chaff, bran, and middlings from grain
milling; wet brewers grains from beverage brewing operations; and
liquid whey from dairy facilities. Some of the by-products from these
facilities are human food products that did not meet quality
specifications for human food use. These out-of-specification products
may be, for example, the wrong size, shape, or texture for human food,
but are safe for use as animal food. Examples of these types of by-
products include potato chips, cookies, bread, pastry products and
pasta. Facilities may distribute the human food by-products directly
for use as livestock food, or may distribute them to another facility
for further processing for food for animals.
Human food facilities are currently subject to the current good
manufacturing practices (CGMPs) regulations found in 21 CFR part 110
and would be subject to the proposed preventive controls for human
food, found in proposed 21 CFR part 117, subpart C, if finalized. In
the 2013 proposed rule for preventive controls for food for animals, we
addressed human food facilities that also provide food for animals (78
FR 64736 at 64754). Proposed Sec. 507.1(d) would have applied to these
facilities and allowed them, for the animal food, the choice of
complying with proposed part 507 for food for animals, subparts B and C
as applicable, or proposed part 117 for human food, subparts B and C as
applicable, so long as the facility addressed any hazards specific to
the animal food.
In the 2013 proposed rule for preventive controls, we also
addressed breweries and distilleries that make alcoholic beverages (78
FR 64736 at 64765). Many of these facilities provide the spent grains
from the brewing or distilling process for use as animal food. In the
2013 proposed rule for preventive controls for human food (78 FR 3646),
we proposed that subpart C, ``Hazard Analysis and Risk-Based Preventive
Controls,'' would not apply to certain alcoholic beverages and a very
narrow set of prepackaged other food at alcoholic beverage facilities,
based on the our interpretation of section 116 of FSMA. Section 116(b)
of FSMA (21 U.S.C. 2206(b)) provides that section 116(a) of FSMA
``shall not apply to a facility engaged in the receipt and distribution
of any non-alcohol food, except that [section 116(a) of FSMA] shall
apply to a facility described in [section 116(a) of FSMA] that receives
and distributes non-alcohol food, provided such food is received and
distributed: (1) In a prepackaged form that prevents any direct human
contact with such food; and (2) in amounts that constitute not more
than 5 percent of the overall sales of such facility, as determined by
the Secretary of the Treasury.'' We stated in the proposed rule for
preventive controls for food for animals that we were not aware of any
animal food at any alcoholic beverage facility that would be exempt
from proposed subpart C, ``Hazard Analysis and Risk-Based Preventive
Controls,'' for food for animals as the spent grains for animal food is
not an alcoholic beverage and is not in a prepackaged form as provided
by section 116 of FSMA.
We have received comments from our stakeholders at public meetings
and through comments to the proposed rule. Some comments stated that
the requirements in proposed Sec. 507.1(d) would potentially create a
need for two separate food safety plans, one for human food and one for
animal food. Some commented that requiring the facility to be subject
to human food and animal food regulations would be a cost burden and as
a result, some facilities would destroy their by-products, most likely
by landfill, instead of complying with the rule for food for animals.
Others commented that by-products used for animal food would not be a
food safety concern because the human food is manufactured/processed or
packed under CGMPs and many of these facilities also would be subject
to the proposed rule for preventive controls for human food. Comments
also said that the hazards that would be reasonably foreseeable for
animal food (e.g., mycotoxins) would also be a hazard reasonably
foreseeable for the human food and thus would be controlled by the
facility by following CGMPs or implementing a food safety plan for the
human food.
Based on comments reviewed to date and on comments made during
public meetings, we considered other possible approaches to regulating
packing and holding of by-products by a human food facility for
distribution as animal food. We first conducted a review of the
potential biological, chemical (including radiological), and physical
hazards for these human food by-products used for animal food. We did
not include hazards associated with human food by-products derived from
animal products, including poultry and seafood (but did include dairy
and egg products). We further limited our review to hazards associated
with human food by-products that were not further processed
[[Page 58488]]
at the facility once separated from the human food because these
processes could introduce hazards that would need to be addressed in a
food safety plan. We reviewed the FDA Reportable Food Registry,
published information about animal food recalls, as well as information
from the CVM Feed Contaminants Program (Ref. 9). In addition, we
conducted a scientific literature review on these by-products used as
animal food (Ref.10).
Though there was not a large volume of data on human food by-
products used as animal food, we tentatively conclude that while there
are biological, chemical, and physical hazards that may be present in
the human food by-products, the information reviewed indicates these
hazards rarely occur.
For example, the reviewed information did not identify any
instances of biological hazards in human food by-products (falling
under the scope of the memorandum) used as animal food. Protein
ingredients derived from meat, offal, poultry, and oil seed meal were
found to be the most common source of biological hazards in animal
food. Facilities providing by-products from these sources for use as
animal food would be subject to proposed part 507, as explained in the
discussion of proposed Sec. 507.12 in this section. Chemical hazards
such as mycotoxins or pesticides are known to be present in human food
ingredients as well as animal food. We have tentatively concluded that
these hazards would be controlled by the human food facilities for the
human food, either under CGMPs or the proposed preventive controls for
human food when finalized. The reviewed information did not identify
any instances of chemical hazards from radionuclides in by-products
used for animal food. The reviewed information did not identify any
instances of physical hazards in human food by-products used as animal
food except instances when the by-products were mistaken for trash and
trash was added to them. We request comment, including additional data,
on the findings of our research on biological, chemical, and physical
hazards of human food by-product used as animal food.
Biological, chemical, or physical hazards in human food by-products
used as animal food, as indicated by the reviewed information, were
either hazards that are not known or reasonably foreseeable, are
prevented or significantly minimized through the human food facility's
compliance with current human food CGMP regulations, or would be
prevented or significantly minimized through the human food facility's
compliance with the proposed preventive controls regulations for human
food, when finalized. The current CGMPs (and the proposed update to
these requirements in the 2013 proposed rule for preventive controls
for human food) as well as other applicable FDA human food safety
regulations, are either the same as or more stringent than the proposed
requirements for animal food. Therefore, we tentatively conclude that a
facility's compliance with proposed subpart B of part 117 and all other
applicable human food safety requirements of the FD&C Act and
implementing regulations are sufficient to help provide animal food
safety until the point of separation from the human food. We request
comments on this tentative conclusion.
The review conducted did not include a search for hazards
associated with seafood by-products. We request comment on how these
by-products are used for animal food, including without further
processing, and if these by-products should be subject to the
requirements for animal food under proposed part 507.
Once the by-product is separated from the human food and is merely
packed and/or held by the human food facility for distribution, the
facility would need to take measures to ensure the animal food does not
become contaminated. For example, during the time the animal food is
held, the facility would need to ensure that the animal food is not
treated like trash or garbage. The facility would need to protect the
animal food from contamination with physical hazards such as floor
sweepings containing glass or metal fragments and from chemical hazards
such as equipment oil, cleaning chemicals, or pesticides used in the
facility. Any of these could be inadvertently incorporated into the
animal food if it was mistaken for trash.
As discussed in further detail in section X of this preamble, we
are also proposing revisions to the proposed CGMPs for animal food.
Particularly, we are proposing a section of CGMPs that would apply to
the packing and holding of by-products in a human food facility for
distribution as animal food. Once the by-product is separated from the
human food, these proposed CGMPs for holding and distribution of the
by-product intended for animal food would prevent or significantly
minimize the known or reasonably foreseeable chemical and physical
hazards that may occur after that separation. We tentatively conclude
that biological and certain chemical hazards, such as mycotoxins and
radionuclides, would not be known or reasonably foreseeable hazards in
the by-products, given how unlikely those are to occur based on the
review. We request comment on these conclusions. Based on the above
conclusions, we have determined that, except for proposed Sec. 507.28
regarding holding and distribution of human food by-products as animal
food, proposed part 507 should not be applicable to these human food
by-products used as animal food. Applying all the requirements set out
in proposed part 507 for these by-products at human food facilities
would not seem to provide any additional animal food safety benefit.
Therefore, in this supplemental notice of proposed rulemaking, we are
proposing revised requirements for human food facilities and the human
food by-products they provide for animal food.
Proposed Sec. 507.12 ``Applicability of this part to the holding
and distribution of human food by-products for use in animal food,''
would address the applicability of part 507 to the holding and
distribution of human food by-products for animal food. Except as
provided in proposed Sec. 507.12(b), the requirements of part 507
would not apply to by-products of human food production that are packed
and held by that facility for distribution as animal food if the
facility is subject to and in compliance with subpart B of part 117 and
all other applicable human food safety requirements of the FD&C Act and
implementing regulations and the facility does not further process the
by-products intended for use as animal food. Proposed Sec. 507.12(b)
would require that once the animal food was separated from the human
food, the facility would need to comply with proposed Sec. 507.28 for
the holding and distribution of that animal food.
A human food facility that further processes the human food by-
product for animal food would be subject to proposed part 507 for those
by-products. This would include by-products that undergo drying,
pelleting, or heat-treatment such as dried brewers' grains, dried whey,
or pelleted citrus pulp. These processes could introduce hazards that
would need to be addressed in a food safety plan.
Proposed Sec. 507.12 would not apply to human food products when
contamination or adulteration has occurred that is materially related
to food safety. We currently have two compliance policy guides that
provide information to facilities that want to divert contaminated or
adulterated human food for animal food use (Ref. 11, Ref.12). We handle
the diversion requests on an individual basis and may not grant a
request after review. Against the backdrop of proposed part 507, we
[[Page 58489]]
request comment on our compliance policy guides for diversion of
adulterated human food products for animal food and whether we should
include regulations for these types of requests.
Proposed Sec. 507.12(b) would not apply to human food by-products
derived from animal products (other than dairy and eggs), such as meat,
offal, or poultry. We tentatively conclude that the hazards,
particularly biological hazards, potentially associated with by-
products from these animal products could be more substantial than
those for the by-products addressed in the memorandum. We request
comment on this conclusion.
Proposed Sec. 117.145 of the supplemental notice of proposed
rulemaking for preventive controls for human food, published elsewhere
in this issue of the Federal Register, addresses proposed corrective
actions and corrections for human food. If a preventive control was
found to be ineffective or was not properly implemented, steps would
need to be taken to evaluate the food for safety and prevent affected
food from entering into commerce if the facility cannot ensure the food
is not adulterated. We request comment on how the facility would
address by-products linked to the affected human food, especially if
the preventive control problem was not discovered until after the
separation of the by-products from the human food and possibly after
the by-products have entered into commerce for use as animal food.
We are also proposing a conforming change to the 2013 proposed rule
for preventive controls for human food part 117 by adding proposed
Sec. 117.95. This proposed section would contain the same requirements
as those contained in proposed Sec. 507.28, but would allow the human
food processor to reference one part of the Code of Federal Regulations
(i.e., part 117, if finalized) to determine the requirements applicable
to the human food by-products used for animal food. We request comment
on this approach. We also request comment on whether proposed Sec.
507.28 should be removed from part 507, if finalized, if proposed Sec.
117.95 is added to part 117, if finalized.
We request comment on these proposed requirements for human food
by-products going to animal food use and request comment on any
additional information available on the known or reasonably foreseeable
hazards in human food by-products packed or held by human facilities
for distribution as animal food. We also request comment on whether by-
products from human dietary supplement and infant formula production
are used for animal food, and if so, how these by-products should be
addressed to help ensure safety of the animal food.
X. Proposed Revisions to Subpart B--Current Good Manufacturing Practice
In this supplemental notice of proposed rulemaking, we are
proposing revisions to the requirements for current good manufacturing
practice regulations (CGMPs) as proposed in the 2013 preventive
controls rule for food for animals. We are proposing these revisions to
the CGMPs based on stakeholder input and initial review of some
comments received in response to the 2013 proposed rule for preventive
controls. In the 2013 proposed rule for preventive controls, we
discussed several sets of CGMPs that had already been developed by
regulatory and animal health organizations, both domestic and
international, that we believed could serve as a starting point for our
proposed CGMPs for manufacturing, processing, packing, and holding food
for animals (78 FR 64736 at 64772). These existing CGMPs included FDA's
CGMP regulations for human food and medicated animal feed (21 CFR part
110 and part 225 respectively), the Association of American Feed
Control Officials (AAFCO) model GMPs for feed and feed ingredients,
best practices recommended by Codex for the feed industry, and the GMPs
recommended in Publicly Available Specification (PAS) 222 (Ref.13, Ref.
14, Ref. 15). We concluded this discussion by saying that because of
our experience and expertise with the human food CGMPs, we tentatively
concluded that our human food CGMPs were the appropriate starting point
for the animal food CGMPs. We then requested comment on whether CGMPs
similar to those for human food are appropriate for animal food, and
whether CGMP requirements appropriate for some types of animal food
might be inappropriate for other types.
Specifically, a major concern we wanted to address with the
proposed revisions is the difficulty of applying one set of CGMPs to
both pet food facilities and livestock feed facilities. Some pet food
facilities, depending on the type of product being manufactured,
resemble human food facilities in that they use wet cleaning procedures
to clean and sanitize food contact surfaces. They also must maintain
high sanitation standards so that their finished product, which will be
handled by pet owners, is free of pathogenic microorganisms. Livestock
feed manufacturers on the other hand avoid the use of water and liquid
cleaning compounds because of the need to maintain dry surfaces in
facilities that predominantly move dry grains, oilseeds, and other dry
ingredients through mixing operations that produce dry finished
products. Sanitizing surfaces is thought to be unnecessary in most
livestock feed facilities because the environment is much less
conducive to microbial growth. We have tentatively concluded that these
proposed revised CGMPs are more applicable to the animal food industry,
provide flexibility for a wide diversity in types of animal food
facilities, and still meet our objectives of establishing enforceable
baseline standards for producing safe animal food. We request comment
on this conclusion.
Proposed Sec. 507.27 ``Holding and distribution'' originated from
Sec. 507.28 ``Warehousing and distribution'' in the 2013 proposed rule
for preventive controls for food for animals. We have retitled the
section ``Holding and distribution'' to better indicate the
requirements would apply to animal food plants in general, not simply
warehouses or distributors/distribution centers. The very general
requirement previously proposed that animal food be protected against
deterioration and biological, chemical, physical, and radiological
contamination during storage and transportation was revised to be more
specific.
Proposed Sec. 507.27(a) would require that animal food held for
distribution must be held under conditions that will protect against
contamination and minimize deterioration of the animal food.
Deterioration of animal food refers to loss of taste, aroma, or
nutritive value typically associated with the animal food. For animal
foods, taste and aroma are linked to palatability and deterioration in
these properties can result in food refusal and wastage. Deterioration
of nutritive value refers to loss of nutrients below amounts that the
food is typically expected to provide. Both food refusal and
consumption of animal food containing fewer nutrients than expected
could result in states of undernourishment that may cause poor
performance and ill health. Animals are typically fed the same food
containing the same ingredients for prolonged periods, making
consistent delivery of expected nutrient content important to prevent
nutritional deficiencies or imbalances.
Contamination of a food can result from biological, chemical, or
physical agents with biological and chemical being the agents most
likely to contribute to deterioration of
[[Page 58490]]
palatability, aroma, and nutritive value of animal food. Microorganism
contamination can lead to production of a chemical hazard, such as when
animal food is contaminated with a mold that subsequently produces a
mycotoxin in the animal food. Holding under appropriate conditions that
minimize the potential for growth of undesirable microorganisms is
particularly important when the animal food is not itself shelf stable
or could be subjected to conditions that adversely impact product
stability. (e.g., raw or frozen pet food). Proposed paragraph (a)(1)
would require that containers used to hold animal food before
distribution be designed, constructed of appropriate material, cleaned,
and maintained to prevent the contamination of animal food.
Proposed paragraph (a)(2) would require that animal food held for
distribution be held in a way that would prevent contamination from
sources such as trash and garbage. This is particularly important when
the animal food is held in bulk containers that could be mistaken for
trash bins.
Proposed paragraph (a)(3) would require that labeling that
identifies the product by the common or usual name be affixed to or
accompany the animal food. The common or usual name is one that is
readily recognized, for example, oats, corn, corn gluten meal, poultry
by-product meal, meat, or dried whey. For byproducts from processing
human food, the names in the AAFCO Official Publication are commonly
used and recognized by industry and state feed programs, and in
Compliance Policy Guide 665.100 ``Common or Usual Names for Animal Feed
Ingredients,'' FDA has generally regarded the AAFCO feed ingredient
definitions as establishing common or usual name of ingredients (Ref.
16). We tentatively conclude that this labeling requirement would
enable the animal producer to use the animal food appropriately or an
establishment receiving the animal food for further manufacture to use
it appropriately. We also tentatively conclude that this labeling
requirement would help prevent accidental comingling or mix-ups of
products at the facility.
Proposed Sec. 507.27(b) would require that shipping containers
such as totes, drums, and tubs, as well as bulk vehicles, used to
distribute animal food be inspected prior to use to ensure the
container or vehicle will not contaminate the animal food. The purpose
of this proposed paragraph would be to help ensure that such articles
for holding and conveying animal food are not a source of contamination
of animal food products.
Proposed Sec. 507.27(c) would require that animal food returned
from distribution be assessed for safety to determine the appropriate
disposition of the animal food and be identified and segregated until
assessed. The animal food plant or facility would not know how that
animal food had been handled prior to return so the animal food could
have been exposed to potential hazards, e.g., the growth of mycotoxin
producing microorganisms if held in a high humidity area. This returned
animal food could contain hazards resulting in contamination that could
result in a food safety concern. If redistributed prior to assessment,
depending on the nature and severity of the contamination, it could
result in injury (or death) to animals.
Proposed Sec. 507.27(d) would require that unpackaged or bulk
animal food be held in a manner that does not result in cross
contamination with other animal food. The purpose of paragraph (d) is
to prevent instances of cross contamination such as food for swine that
contains mammalian protein (that is prohibited for use in food for
ruminants) contaminating food intended for cattle.
Revised proposed Sec. 507.28 is now titled ``Holding and
distribution of human food by-products for use as animal food.'' The
revised proposed requirements are a subset of those in proposed Sec.
507.27 and would specifically apply to human food processers that have
certain by-products (as identified in proposed Sec. 507.12) as a
result of manufacturing human food and pack or hold the by-products for
distribution for use as animal food. Since the human food would be
subject to proposed part 117 subpart B and any other applicable FDA
human food safety requirements of the FD&C Act and implementing
regulations, we have tentatively concluded that hazards would be
adequately controlled by these requirements in conjunction with the
requirements of proposed Sec. 507.28. Proposed Sec. 507.28 would
contain the CGMPs we tentatively conclude would be necessary for animal
food safety once the by-products are separated from human food and
become animal food.
As discussed in section IX, we are proposing a new Sec. 507.12 for
the applicability of part 507 to human food by-products used for animal
food. Under proposed Sec. 507.12, part 507 would not apply to by-
products of human food production meeting the requirements of proposed
Sec. 507.12(a), except as provided in Sec. 507.12(b). Proposed Sec.
507.12(b) would require that the animal food from by-products
identified in proposed Sec. 507.12(a), be held and distributed by that
facility in accordance with Sec. 507.28 of part 507 and proposed Sec.
117.95 of part 117.
The following is a brief summary of the proposed revisions to the
CGMPs in proposed subpart B. In making the revisions, we also found it
necessary to rearrange and retitle some of the sections, and make
wording changes that we felt simplified the requirements and improved
clarity. The details of these proposed requirements are in the re-
proposed regulatory text for proposed subpart B.
Sec. 507.14--Personnel
Removed paragraphs (a)(1) and (a)(2) pertaining to ill
employees and the requirement for employees to report illnesses to
their supervisors. This change was made because we are not aware of any
evidence of disease being transmitted from ill employees involved in
manufacturing animal food to animals through the animal food.
Sec. 507.17--Plant and grounds
Primarily wording changes to consolidate requirements.
Sec. 507.19--Sanitary operations
Changed section title to ``Sanitation'';
Divided paragraph (a) into two categories--(a) pertaining
to buildings, fixtures, and other physical facilities, and (b)
pertaining to utensils and equipment;
Changed the wording in new paragraph (b) to say that
utensils and equipment must be cleaned, maintained, and stored as
necessary and appropriate to protect against contamination of animal
food, animal food-contact surfaces, or animal food-packaging materials;
Consolidated requirements, changed the order to group like
requirements, and simplified the wording; and
Eliminated the requirement pertaining to single-service
articles, which are not typically used in animal food facilities.
Sec. 507.20--Sanitary facilities and controls
The title was changed to ``Water supply and plumbing'';
This section contains only requirements related to the
water supply and plumbing. The rubbish (reworded to trash and garbage)
requirement was moved to Sec. 507.19 Sanitation; and
Wording changes were made for simplification.
[[Page 58491]]
Sec. 507.22--Equipment and utensils
Requirements consolidated; and
Wording changes made for simplification.
Sec. 507.25--Processes and controls
Title changed to ``Plant operations'';
Changed paragraph (a)(1) to require that plant operations
be conducted in accordance with the CGMPs in subpart B rather than in
accordance with adequate sanitation principles;
Added requirements in paragraph (a)(9) that all animal
food manufacturing, processing, packing, and holding must be conducted
under such conditions and controls as are necessary to minimize the
potential for the growth of microorganisms or for the contamination of
animal food;
Omitted the requirement in paragraph (b)(2) that raw
materials and ingredients must not contain microorganisms injurious to
human or animal health, or the raw materials and ingredients must be
treated to eliminate them. This change was made because we do not
intend that incoming raw materials and ingredients must be tested for
pathogens, though the facility may choose to do so;
Requirements pertaining to processes and products used for
human food but not animal food, such as heat blanching, batters,
breading, sauces, and dressings were omitted; and
Requirements consolidated and wording simplified.
Sec. 507.28--Warehousing and distribution
Section renumbered to Sec. 507.27;
Title changed to ``Holding and distribution'';
The very general requirement previously proposed that
animal food be protected against deterioration and biological,
chemical, physical, and radiological contamination during storage and
transportation was revised to be more specific. We are now proposing
that the following requirements apply to animal food held for
distribution:
Animal food held for distribution must be held under
conditions (for example, appropriate temperature, relative humidity,
appropriate holding time) that minimize the potential for growth of
undesirable microorganisms;
Containers used to hold animal food before distribution
must be designed, constructed of appropriate material, cleaned, and
maintained to prevent the contamination of animal food;
Animal food held for distribution must be held in a way
that prevents contamination from sources such as trash and garbage;
Labeling identifying the product by the common or usual
name must be affixed to or accompany the animal food;
Shipping containers (e.g., totes, drums, and tubs) and
bulk vehicles used to distribute animal food must be inspected prior to
use to ensure the container or vehicle will not contaminate the animal
food;
Animal food returned from distribution must be assessed
for animal food safety to determine the appropriate disposition.
Returned animal food must be identified as such and segregated until
assessed; and
Unpackaged or bulk animal food must be held in a manner
that does not result in cross contamination with other animal food.
Sec. 507.28--Holding and distribution of human food by-
products for use as animal food
The following new requirements were added:
Human food by-products held for distribution as animal
food must be held under conditions that will protect against
contamination, including the following:
Containers used to hold animal food before distribution
must be designed, constructed of appropriate material, cleaned, and
maintained to prevent the contamination of animal food;
Animal food held for distribution must be held in a way to
prevent contamination from sources such as trash and garbage;
Labeling identifying the by-product by the common or usual
name must be affixed to or accompany animal food;
Shipping containers (for example, totes, drums, and tubs)
and bulk vehicles used to distribute animal food must be inspected
prior to use to ensure the container or vehicle will not contaminate
the animal food; and
We request comments on these proposed revisions to subpart B.
XI. Overall Framework for Hazard Analysis and Risk-Based Preventive
Controls
A. 2013 Proposed Overall Framework for Hazard Analysis and Risk-Based
Preventive Controls
In general, in the 2013 proposed rule for preventive controls, we
proposed that the owner, operator, or agent in charge of a facility:
Prepare and implement a food safety plan, which would
include documentation such as a written hazard analysis and various
written procedures;
Conduct a hazard analysis to identify and evaluate known
or reasonably foreseeable hazards to determine whether there are
hazards that are ``reasonably likely to occur'';
Identify and implement preventive controls, including at
CCPs, if any, to provide assurances that hazards identified as
``reasonably likely to occur'' will be significantly minimized or
prevented;
Establish a written recall plan for animal food with a
hazard identified as ``reasonably likely to occur'';
Monitor the preventive controls with adequate frequency to
provide assurance that they are consistently performed;
Establish and implement written corrective action
procedures that must be taken if preventive controls are not properly
implemented;
Take appropriate corrective action in the event of an
unanticipated problem if a preventive control is not properly
implemented and a specific corrective action procedure has not been
established;
Conduct certain verification activities; and
Establish and maintain certain records.
These proposed provisions applied a construct we previously used in
our Hazard Analysis and Critical Control Point (HACCP) regulations for
seafood (21 CFR part 123) and juice (21 CFR part 120), i.e., whether a
known or reasonably foreseeable hazard was ``reasonably likely to
occur.'' In general, our HACCP regulations for seafood and juice focus
on CCPs to control hazards that are ``reasonably likely to occur.''
B. Comments on the ``Reasonably Likely To Occur'' Construct Within the
2013 Overall Framework for Hazard Analysis and Risk-Based Preventive
Controls
Some stakeholders expressed concern, during outreach activities
such as the public meetings and in written comments, about including
the ``reasonably likely to occur'' approach in the 2013 proposed rules
for preventive controls for human and animal food. The concern was that
using the phrase ``reasonably likely to occur'' in two different
contexts (i.e., within our HACCP regulations as well as in its proposed
preventive controls regulations for human and animal food) would be
confusing. Some comments received under the proposed rule for
preventive controls for human food considered that the ``reasonably
likely to
[[Page 58492]]
occur'' approach was already so closely linked to our HACCP regulations
that the 2013 proposed rules for preventive controls for human and
animal food would be interpreted as requiring that all necessary
preventive controls be established at CCPs. These comments note that
such an interpretation would be inconsistent with FSMA. For example,
FSMA requires that the owner, operator, or agent in charge of a
facility identify and implement preventive controls, including at
critical control points, if any (emphasis added) (section 418(c) of the
FD&C Act). In addition, the definition of ``preventive controls'' in
FSMA is broader than CCPs (section 418(o)(3) of the FD&C Act). The
comments ask that we more explicitly provide for implementation of a
range of preventive controls (not just at CCPs). These comments also
express concern that a facility that already had established controls
to address hazards--but not at CCPs--would need to revise its food
safety plan, re-create any applicable records (e.g., various written
procedures) to satisfy the recordkeeping requirements of the rule,
which would add costs but no food safety benefits. For further
discussion of these comments, please see supplemental notice of
proposed rulemaking for preventive controls for human food published
elsewhere in this issue of the Federal Register.
C. Proposed Revisions to the Overall Framework for Hazard Analysis and
Risk-Based Preventive Controls
The 2013 proposed rule for preventive controls would not have
required that all preventive controls be established at CCPs. However,
we acknowledge that it could be confusing to use the same phrase
``reasonably likely to occur'' in both the our HACCP regulations and in
the regulations we are proposing to establish to implement FSMA's
requirements for hazard analysis and risk-based preventive controls,
because the phrase ``reasonably likely to occur'' has been used as the
basis for determining hazards that need to be addressed in a HACCP plan
at CCPs.
Likewise, the 2013 proposed rule for preventive controls would not
have limited a facility's flexibility to develop and implement a food
safety system that was indeed risk-based. However, we acknowledge that
some specific changes to the proposed regulatory text could help to
clarify the risk-based nature of all provisions of subpart C.
We have not used the term ``prerequisite program'' in the proposed
regulatory text because, like ``hazard reasonably likely to occur,'' it
has a connotation with respect to our seafood and juice HACCP programs,
that is, it connotes activities that a facility may do that have an
impact on product safety but which are outside the scope of the
regulatory program. However, comments are not suggesting that
prerequisite programs that are essential to ensuring food safety should
be outside the scope of this proposed regulatory scheme. In fact,
comments asking that we recognize the role of prerequisite programs in
the management of hazards point out that preventive controls include
control measures that do not include CCPs and that companies would
consider many of these to be prerequisite programs. We acknowledge that
oftentimes preventive controls, other than those at critical control
points, are important parts of a food safety system, and must therefore
be included in the food safety plan that would be required by this
proposed rule. We attempted to make that clear in the proposed
requirement for preventive controls in Sec. 507.36(a) by incorporating
reference to ``controls, other than those at critical control points,
that are necessary for food safety.''
We did not intend to require that a facility re-create or duplicate
existing records associated with controls; we simply laid out in the
2013 proposed rule for preventive controls the activities for which we
expect there to be records and the information we expect to find in
those records.
Taking into account the comments we have reviewed so far, we are
proposing a series of revisions to proposed subpart C and are reopening
the comment period specifically with respect to these proposed
revisions. These proposed revisions include:
Eliminating the term ``hazard reasonably likely to occur''
throughout proposed subpart C (and, thus, deleting the definition we
had proposed for this term).
Adding a new defined term, ``significant hazard,'' and, in
general, using this new term instead of ``hazard reasonably likely to
occur'' throughout the proposed regulations. ``Significant hazard''
would mean a known or reasonably foreseeable hazard for which a person
knowledgeable about the safe manufacturing, processing, packing, or
holding of animal food would, based on the outcome of a hazard
analysis, establish controls to significantly minimize or prevent the
hazard in an animal food, and components to manage those controls (such
as monitoring, corrections or corrective actions, verification, and
records) as appropriate to the animal food, the facility, and the
nature of the control.
Defining ``known or reasonably foreseeable hazard'' in
place of ``reasonably foreseeable hazard'' and clarifying that the new
term means a hazard ``that has the potential to be associated with the
facility or the food'' rather than ``a potential . . . hazard that may
be associated with the facility or the animal food'';
Providing additional flexibility to address concerns about
re-writing existing plans or programs to conform with the requirement
of the preventive controls rule by explicitly providing that:
Preventive controls include controls, other than those at
critical control points, that knowledgeable persons commonly recognize
as appropriate for animal food safety;
The preventive control management components (i.e.,
monitoring, corrective actions, and verification) depend on the nature
of the control; and
The recordkeeping requirements do not require duplication
of existing records if those records contain all of the required
information and satisfy the recordkeeping requirements of the
regulation. Existing records may supplemented as necessary to include
all of the required information. In addition, the required information
does not need to be kept in one set of records. If existing records
contain some of the required information, any new information required
by the preventive controls rule may be kept either separately or
combined with the existing records.
The framework provided by ``significant hazard'' would reflect a
two-part analysis on the part of a facility. First, the facility would
narrow ``hazards'' to those hazards that are known or reasonably
foreseeable--i.e., those biological, chemical (including radiological),
or physical hazards that have the potential to be associated with the
facility or the food. Second, the facility would narrow the known or
reasonably foreseeable hazards to those that a person knowledgeable
about the safe manufacturing, processing, packing, or holding of food
would, based on the outcome of a hazard analysis, establish controls to
significantly minimize or prevent the hazard in an animal food, as well
as components to manage those controls (such as monitoring, corrections
or corrective actions, verification, and records) as appropriate to the
animal food, the facility, and the nature of the control.
The framework established by ``significant hazard'' also would
incorporate the concept of risk by specifying that ``significant
hazards'' are based on the outcome of a hazard
[[Page 58493]]
analysis. The hazard analysis would require an evaluation of known or
reasonably foreseeable hazards to assess two key aspects of risk--i.e.,
the severity of the illness or injury to humans or animals if the
hazard were to occur and the probability that the hazard will occur in
the absence of preventive controls.
See the revised regulatory text for the proposed new definition of
``significant hazard'' (proposed Sec. 507.3). The term ``significant
hazard'' has sometimes been used in the context of HACCP to refer to
the hazards to be addressed in a HACCP plan through CCPs. However, this
term is not used in the seafood, juice or meat and poultry HACCP
regulations, which focus on ``hazards reasonably likely to occur.'' We
request comment on both the proposed name of the term and the proposed
meaning of the term. See also the proposed new provision for the use of
existing records (proposed Sec. 507.212, which would be established in
subpart F). Table 6 provides some examples of the flexibility that a
facility would have in complying with the revised requirements that
would be established in subpart C.
Table 6--Examples of Flexibility for Complying With the Requirements for
Hazard Analysis and Risk-Based Preventive Controls in the Revised
Requirements in Proposed Subpart C
------------------------------------------------------------------------
Flexibility related to . . . Example
------------------------------------------------------------------------
Controls other than those at CCPs....... Dividing a facility into zones
based on the risk with
respect to contamination of
product can be a preventive
control, but would not have a
CCP.
Controls other than those at CCPs....... Preventive maintenance that
inspects and changes pre-
conditioner blades for a
single screw extruder system
at regular intervals may be
considered a PC in some
instances but would not have
a CCP.
Circumstances that do not require Supplier controls.
process controls.
Monitoring activity that generally would Monitoring for pieces of
not require records. ferrous metal with magnets.
Corrections that generally would not Re-cleaning inadequately
require records. cleaned animal food contact
surfaces before start up.
Preventive controls that would not Zoning controls.
require validation.
Preventive controls that would not Segregation of animal food
require validation. intended for different
species during storage.
Preventive controls that would not Training.
require validation.
Preventive controls that would not Preventive maintenance.
require validation.
Preventive controls that would not Refrigerated storage.
require validation.
Corrective action that generally would Replacement of equipment.
not require verification.
------------------------------------------------------------------------
XII. Potential Requirements for Product Testing and Environmental
Monitoring
A. Our Request for Comment on Including Requirements for Product
Testing and Environmental Monitoring in a Final Rule
In the 2013 proposed rule for preventive controls, we described the
statutory framework of FSMA for product testing and environmental
monitoring as verification measures. We also requested comment on when
and how product testing programs and environmental monitoring are an
appropriate means of implementing section 418 of the FD&C Act (78 FR
64736 at 64836 and 78 FR 3646 at 3762-3765). We specifically requested
comment on including requirements for product testing programs and
environmental monitoring in a final rule. Although we did not propose
specific regulatory text, we asked a series of questions about what
such requirements should include. Our discussions and questions about
``product testing'' focused on ``finished product testing.'' The
Appendix contained extensive background on the role of testing as a
verification measure in a modern food safety system (78 FR 64736 at
64834).
B. Product Testing
1. Comments on Product Testing
Some comments support product testing as a verification activity
and make recommendations for what should be tested, how testing could
be tied to risk, and how product testing could be used in a food safety
plan. Some of these comments emphasize that product testing would not
be appropriate as a control measure. Other comments do not support
including requirements for ``finished product testing'' as a
verification measure, but support including requirements for ``product
testing'' in the final rule if the focus is broader than ``finished
product testing,'' the use of product testing is tied to risk, and the
regulations provide flexibility in how product testing is used in a
food safety plan. Commenters with varying views on the issue
nonetheless requested that FDA include proposed regulatory text for
consideration.
For a full discussion of comments received to the 2013 proposed
rule for preventive controls for human food, see section X.B.1 of the
supplemental notice of proposed rulemaking for preventive controls for
human food published elsewhere in this issue of the Federal Register.
2. Potential Requirements for Product Testing
We acknowledge that there are limitations to product testing.
Nonetheless, product testing programs, when implemented appropriately
based on the facility, the animal food, and the nature of the
preventive control, could be used to verify that the preventive
controls are effectively and significantly minimizing or preventing the
occurrence of identified hazards. Taking into account the comments we
have reviewed so far, we are providing an opportunity for public
comment on potential requirements for product testing. Such
requirements would be tied to risk and addressed through flexible
written procedures that would address both test procedures and
corrective action plans.
In this section of this document, we are reopening the comment
period with respect to our previous request for comment on when and how
product testing programs are an appropriate means of implementing FSMA.
We are seeking comment on whether requirements for product testing
should be included in a final rule and, if so, what (if any)
modifications to the proposed regulatory text would be appropriate. The
proposed regulatory
[[Page 58494]]
text would, if included in a final rule, establish requirements for:
Product testing as an activity for verification of
implementation and effectiveness as appropriate to the facility, the
animal food, and the nature of the preventive control (proposed Sec.
507.49(a)(2));
Written procedures for product testing (proposed Sec.
507.49(b)(2));
Corrective action procedures for product testing (proposed
Sec. 507.42(a)(1)(ii)(A)); and
Records of product testing (proposed Sec. 507.45(b));
See the proposed regulatory text for proposed subpart C for the
full text of such potential requirements. Consistent with the requests
of the comments, proposed regulatory text would provide flexibility for
a facility to make risk-based decisions on when product testing would
be appropriate by providing that the facility can take into account the
facility, the animal food, and the nature of the preventive control
(e.g., whether the control is a kill step) rather than prescribe
product testing in specific circumstance, or require that all types of
facilities (including warehouses) conduct product testing. For
supplementary information relevant to product testing, see the 2013
proposed rule for preventive controls (78 FR 64736 at 64805-64806), the
Appendix in that proposed rule (78 FR 64736 at 64834-64836), and
section X.B in the supplemental notice of proposed rulemaking for
preventive controls for human food published elsewhere in this issue of
the Federal Register.
C. Environmental Monitoring
1. Comments on Environmental Monitoring
Some comments support environmental monitoring as a verification
activity. In general, these comments recommend that the final rule
specifically require environmental monitoring when ready to eat product
(for human food) is exposed to the environment prior to packaging and
the packaged food does not receive a treatment that would significantly
minimize an environmental pathogen that could contaminate the animal
food when it is exposed (note that under the 2013 preventive controls
rule for animal food, the term ready to eat (RTE) is not used. All
finished animal food is considered ready to eat, but it may not require
packaging.) Comments emphasize the need for flexible requirements that
would allow facilities to tailor their programs based on risk.
Some comments that generally support environmental monitoring as a
verification activity nonetheless express concern about the potential
for such requirements to be overly prescriptive. Comments particularly
express concern about potentially prescriptive requirements for
corrective actions if an environmental pathogen or appropriate
indicator organism is detected.
Some comments do not support including requirements for
environmental monitoring as a verification measure. Some of these
comments assert that requirements for environmental monitoring would
not be in accord with guidelines issued by the Codex Alimentarius
Commission (Codex). Some comments note that environmental monitoring
would not be relevant to all products, such as products that will be
heat-treated or subject to a kill-step. Other comments note that
environmental monitoring would not be relevant to facilities such as
food distributors, due to the low likelihood of product contamination
occurring in storage and distribution centers. Some of these comments
express concern about broad requirements that would require
environmental monitoring in a manner that was not risk-based, such as
when an environmental pathogen is not reasonably likely to occur. Some
commenters with varying views on the issue nonetheless asked FDA to
issue proposed regulatory text for environmental monitoring for
consideration.
2. Potential Requirements for Environmental Monitoring
Although the HACCP Annex of the Codex General Principles of Food
Hygiene (Ref. 17) does not specifically recommend environmental
monitoring as a verification activity in HACCP systems, the Codex
General Principles of Food Hygiene (Ref. 18) does indicate that
sanitation systems should be monitored for effectiveness and
periodically verified, where appropriate, by microbiological sampling
of environment and food contact surfaces, and regularly reviewed and
adapted to reflect changed circumstances. Currently available data and
information support the role of environmental monitoring in a food
safety system that incorporates hazard analysis and risk-based
preventive controls. (See, e.g., the 2013 proposed rules for preventive
controls for animal food and human food (78 FR 64736 at 64806-64807 and
78 FR 3646 at 3764-3765 respectively) and the Appendices in the animal
food and human food 2013 proposed rules (78 FR 64736 at 64834-64836 and
78 FR 3646 at 3812-3820 respectively.) See also and section X.C.2 of
the supplemental notice of proposed rulemaking for preventive controls
for human food published elsewhere in this issue of the Federal
Register.). Environmental monitoring programs, when implemented
appropriately based on the facility, the animal food, and the nature of
the preventive control, could be used to verify that the preventive
controls are effectively and significantly minimizing or preventing the
occurrence of identified hazards.
Taking into account the comments we have reviewed so far, we are
providing an opportunity for public comment on potential requirements
for environmental monitoring. The potential requirements would provide
flexibility for animal food facilities to tailor their environmental
monitoring programs based on risk. Environmental monitoring would be
required in the specific circumstances where an animal food product is
exposed to the environment prior to packaging, such as dog and cat food
kibble, and the packaged animal food does not receive a treatment that
would significantly minimize an environmental pathogen that could
contaminate the animal food when it is exposed. However, the potential
requirements would not otherwise specify circumstances where
environmental monitoring would be required and would instead require
that the animal food facility conduct environmental monitoring as
appropriate to the facility, the animal food, and the nature of the
preventive control. The potential requirements would also not be
prescriptive in the types of corrective actions needed in response to
detecting an environmental pathogen or appropriate indicator organism
in the environment; they would provide flexibility for facilities to
establish and implement written corrective action procedures to
identify and correct the problem, reduce the likelihood that the
problem will recur, evaluate all affected animal food for safety, and,
as necessary, prevent affected animal food from entering commerce.
In this section of this document, we are reopening the comment
period with respect to our previous request for comment on when and how
environmental monitoring is an appropriate means of implementing FSMA.
We are seeking comment on whether requirements for environmental
monitoring should be included in a final rule and, if so, what (if any)
modifications to the proposed regulatory text would be appropriate. The
proposed regulatory text would, if
[[Page 58495]]
included in a final rule, establish requirements for:
Performing, as part of the hazard evaluation, an
evaluation of environmental pathogens whenever an animal food is
exposed to the environment prior to packaging and the packaged food
does not receive a treatment that would significantly minimize the
pathogen (proposed Sec. 507.33(c)(2));
Environmental monitoring, for an environmental pathogen
(e.g., Salmonella spp) or for an appropriate indicator organism (e.g.,
Listeria spp for L. monocytogenes), as an activity for verification of
implementation and effectiveness as appropriate to the facility, the
food, and the nature of the preventive control, if contamination of an
animal food with an environmental pathogen is a significant hazard
(proposed Sec. 507.49(a)(3));
Records of environmental monitoring (proposed Sec.
507.45(b));
Written procedures for environmental monitoring (proposed
Sec. 507.49(b)(3)); and
Corrective action procedures for environmental monitoring
(proposed Sec. 507.42(a)(1)(ii))(B).
See the proposed regulatory text for proposed subpart C for the
full text of such potential requirements. For supplementary information
relevant to environmental monitoring programs, see the 2013 proposed
rules for preventive controls for animal food and human food (78 FR
64736 at 64806-64807 and 78 FR 3646 at 3764-3765), the Appendices for
animal food and human food (78 FR 64736 at 64834-64836 and 78 FR 17142
at 17143-17151), and section X.C.2 of the supplemental notice of
proposed rulemaking for preventive controls for human food published
elsewhere in this issue of the Federal Register.
XIII. Potential Requirements for a Supplier Program
A. Our Request for Comment on When and How Supplier Verification
Activities Are an Appropriate Means of Implementing the Statutory
Framework of Section 418 of the FD&C Act
In the 2013 proposed rule for preventive controls, we described the
statutory framework of FSMA for supplier controls, i.e., the supplier
verification activities that section 418 of the FD&C Act includes as an
example of preventive controls. We also requested comment on when and
how supplier verification activities are an appropriate means of
implementing section 418 (78 FR 64736 at 64804-64809). We specifically
requested comment on including requirements for supplier approval and
other verification activities in a final rule. Although we did not
propose specific regulatory text, we asked a series of questions about
what such requirements should include. The Appendix contained extensive
background on the role of supplier programs in a modern food safety
system (78 FR 64736 at 64836-64837).
B. Comments on When and How Supplier Verification Activities Are an
Appropriate Means of Implementing the Statutory Framework of Section
418 of the FD&C Act
Some comments support including requirements for a supplier program
in a final rule. These comments emphasize the need for flexible
requirements that would allow facilities to tailor their programs based
on risk, including risk inherent to raw materials and ingredients and
risk that may be associated with a particular supplier (e.g., as
reflected by the supplier's performance history). These comments
provide many specific recommendations for what such requirements
should--and should not--include. We summarize these recommendations in
Table 7.
Table 7--Summary of Specific Recommendations in Comments That Support
Requirements for a Supplier Program
------------------------------------------------------------------------
Most comments do not support a
Most comments support a requirement: requirement:
------------------------------------------------------------------------
For receiving raw material and For a written list of approved
ingredients from approved suppliers. suppliers (because the list
would be subject to frequent
(perhaps daily) change).
For verification of a facility's For verification of the
immediate supplier. supplier's supplier (because
the facility has the greatest
knowledge, leverage and
ability to conduct meaningful
oversight of its immediate
supplier and because it is the
supplier who is accountable to
verify back one more step).
For records documenting that the basic For documents such as an
requirements are being carried out. underlying audit report
(because of concerns about
confidential information).
For audits as a verification activity, Prescribing the frequency of
provided that the requirements are audits (particularly an annual
flexible and audits are not over- frequency) (because an audit
emphasized at the expense of other is only one tool and audits
verification activities. should be based on risk and on
the performance of the
supplier).
Limiting a supplier program to Specifying that some hazards
facilities that manufacture or process require more than one
food. verification activity (because
doing so would be too
prescriptive and would not
allow the facility the
flexibility to determine the
appropriate risk-based
approach).
For oversight of a supplier program by For a receiving facility to
a qualified individual. identify the regulations to
which the supplier is subject
(because the distinction would
not be material to food
safety).
That would be consistent with the
Foreign Supplier Verification Program
being established in a separate
rulemaking.
Specifying that a supplier program may
be managed at a corporate level
(rather than by specific facilities),
because supplier programs are often
managed at the corporate level. Some
comments specifically recommend that
inspection of a supplier program take
place at the location where the
program is managed, including at a
corporate location rather than at an
individual facility.
------------------------------------------------------------------------
Comments also address several other issues, such as whether the
final rule should:
Be limited to circumstances where a hazard is controlled
by the supplier, or be required even if the hazard would be controlled
by the receiving facility or by the receiving facility's customer.
[[Page 58496]]
Include requirements for specific types of verification
activities based only on the seriousness of hazards. Although some
comments support such requirements, other comments do not because the
basis should be risk (which includes probability as well as severity).
Allow substitution of an inspection (e.g., by FDA) for an
audit. Although some comments support such a substitution, others do
not because they assert that an inspection and an audit are different
in nature.
Require a receiving facility to consider relevant
regulatory information about the supplier. Although some comments
support such requirements, others do not (e.g., because the information
(which can be part of an overall supplier assessment) may not be
available in a timely manner, is narrow in scope, and would diminish
the importance of the supplier's food safety plan and the effectiveness
of its implementation).
Include requirements related to supplier non-conformance.
Although some comments support such requirements, others maintain that
supplier non-conformance would be better suited to guidance. Some
comments specifically oppose a requirement for ``discontinuing use of
the supplier'' and recommend flexibility for how a receiving facility
would address supplier non-conformance.
Provide for alternative verification requirements when a
supplier is a qualified facility (which is subject to modified
requirements; see proposed Sec. 507.7 in the 2013 proposed rule for
preventive controls). Although some comments support alternative
requirements for suppliers that are qualified facilities, others
express concern about whether alternative requirements can be
practically implemented. Some comments state that the supplier
verification requirements should not prevent facilities from sourcing
ingredients from suppliers that are qualified facilities.
In general, comments that simply oppose including a supplier
program in the final rule express concern about cost, ingredient
diversity, and duplication of efforts. Some of these comments recommend
that we issue guidance on supplier verification activities rather than
establish requirements in the final rule. Some commenters, including
those with varying views about the issue, nonetheless requested that
FDA propose regulatory language for consideration.
C. Potential Requirements for a Supplier Program
Section 418 of the FD&C Act specifically identifies supplier
verification activities as a preventive control (see section 418(o)(3)
of the FD&C Act). Supplier controls, when implemented appropriately,
are an important preventive control that can ensure that significant
hazards will be significantly minimized or prevented for those raw
materials and ingredients for which the receiving facility has
identified a significant hazard when the hazard is controlled before
receipt of the raw material or ingredient. Taking into account the
comments reviewed so far, we are providing an opportunity for public
comment on potential requirements for a supplier program as a
preventive control. In this section of this document, we are reopening
the comment period with respect to our previous request for comment on
when and how supplier programs are an appropriate means of implementing
FSMA. We are seeking comment on whether requirements for a supplier
program should be included in a final rule and, if so, what (if any)
modifications to the proposed regulatory text would be appropriate.
Elsewhere in this issue of the Federal Register, we are issuing a
supplemental notice of proposed rulemaking to amend the 2013 proposed
FSVP rule. In that supplemental notice we request comment, in light of
the statutory provisions, on the manner and extent to which the FSVP
and any preventive controls supplier verification provisions--as well
as other aspects of the FSVP and preventive controls regulations--
should be aligned in the final rules.
See the proposed regulatory text (proposed Sec. 507.37 and the
applicable definitions in proposed Sec. 507.3) for the full text of
such potential requirements. Briefly, the proposed regulatory text
would, if included in a final rule:
Establish definitions for terms used in the potential
requirements for a supplier program (i.e., receiving facility;
supplier; and qualified auditor) (proposed Sec. 507.3)
Establish a risk-based requirement for a written supplier
program that:
Would require, with some exceptions, a supplier program
for raw materials and ingredients for which the receiving facility has
identified a significant hazard when the hazard is controlled before
receipt of raw material or ingredient (proposed Sec. 507.37(a)(1)
and(a)(2)); and
Would not apply to raw materials and ingredients for which
there are no significant hazards, the preventive controls at the
receiving facility are adequate, or the receiving facility relies on
the customer and obtains written assurance (proposed Sec.
507.37(a)(1)(ii));
Require verification activities, as appropriate to the
hazard, and documentation of such activities, to ensure raw materials
and ingredients are received only from suppliers approved for control
of the hazard(s) in that raw material or ingredient (or, when necessary
and appropriate, on a temporary basis, from unapproved suppliers whose
raw materials or ingredients the receiving facility subjects to
adequate verification activities before acceptance for use) (proposed
Sec. 507.37(a)(3)(i));
Require verification activities to verify that the hazard
is significantly minimized or prevented, the incoming raw material or
ingredient is not adulterated under section 402 of the FD&C Act, and
the incoming raw material or ingredient is produced in compliance with
the requirements of applicable FDA food safety regulations (proposed
Sec. 507.37(a)(3)(ii));
Provide flexibility for a receiving facility to determine
and document the appropriate verification activities for raw materials
and ingredients from particular suppliers, based on a series of
factors, except when there is a reasonable probability that exposure to
a significant hazard will result in serious adverse health consequences
or death to humans or animals (proposed Sec. Sec. 507.37(b) and
507.37(c)(1)) (see next bullet);
Require an annual audit as a verification activity when
there is a reasonable probability that exposure to the hazard will
result in serious adverse health consequences or death to humans or
animals, unless the receiving facility documents its determination that
other verification activities and/or less frequent onsite auditing of
the supplier provide adequate assurance that the hazards are controlled
(proposed Sec. 507.37(c)(2));
Provide for an alternative verification activity when the
supplier is a qualified facility (proposed Sec. 507.37(c)(3));
Provide for alternative verification activities when the
supplier is a farm that would not be subject to the requirements in the
final produce safety rule under proposed Sec. 112.4 (proposed Sec.
507.37(c)(4));
Require that an audit be conducted by a qualified
individual who has technical expertise obtained by a combination of
training and experience appropriate to perform the auditing
[[Page 58497]]
function (proposed Sec. 507.37(d)(1)) and proposed Sec. 507.53);
Provide that inspection by FDA or an officially recognized
or equivalent food safety authority may substitute for an audit
(proposed Sec. 507.37(e));
Require action to address supplier non-conformance
(proposed Sec. 507.37(f)); and
Require documentation of verification activities in
records (listed in proposed Sec. 507.37(g)), including minimum
requirements for records documenting an audit, records of sampling and
testing, and records documenting a review by the receiving facility of
the supplier's relevant food safety records (proposed Sec.
507.37(g)(5), (g)(6), and (g)(7), respectively).
In addition, the potential addition of requirements for a supplier
program would require conforming amendments to other provisions of the
rule, including the requirements for a food safety plan, preventive
controls, validation, verification of implementation and effectiveness,
and the list of implementation records for subpart C (see proposed
Sec. Sec. 507.31(c)(3), 507.36(c)(3), 507.39(b), 507.47(b)(3),
507.49(a)(4), and 507.55(a)(4) respectively). For supplementary
information relevant to a supplier program, see the 2013 proposed rule
for preventive controls (78 FR 64736 at 64807-64809), Appendix (78 FR
64736 at 64836-64837) and section XI.C of the supplemental notice of
proposed rulemaking for the preventive controls for human food
published elsewhere in this issue of the Federal Register. In the
following paragraphs, we provide additional information about the
potential requirements for a supplier program.
Reflecting the risk-based (including severity as well as
probability) nature of a potential supplier program, a receiving
facility's program would be limited to those raw materials and
ingredients for which the receiving facility has identified a
significant hazard. As discussed in section XI.C, ``significant
hazard'' would be defined in the rule. Under the definition, hazards
are determined to be significant based on the outcome of a hazard
analysis and, thus the determination would incorporate the concept of
risk. In addition, a receiving facility would establish and implement a
supplier program only when a significant hazard is controlled before
receipt; a receiving facility would not be required to establish and
implement a supplier program if the receiving facility, or the
receiving facility's customer, controls the hazard (and the customer
provides assurances as to the control). Under this risk-based approach,
a pet food manufacturer generally would be required to establish a
supplier program for hazards associated with the minerals it processes
(which would be controlled by the supplier during manufacture), but a
manufacturer of dry pet food would not be required to establish a
supplier program for microbial hazards in poultry by-products that it
uses to produce the dry pet food if it will control that hazard for the
poultry by-products during manufacture of the pet food (e.g., through a
heat kill step such as the extrusion process).
The potential supplier program would include requirements
applicable to a ``receiving facility'' and the proposed definition of
``receiving facility'' would describe a receiving facility as a
facility that manufactures/processes a raw material or ingredient that
it receives from a supplier. A supplier would be defined as the
establishment that manufactures/processes the food, raises the animal,
or harvests the food that is provided to a receiving facility without
further manufacturing/processing by another establishment, except for
further manufacturing/processing that consist solely of the addition of
labeling or similar activity of a de minimis nature. The supplier could
be an ``establishment'' rather than a ``facility'' because a supplier
may be an entity that is not required to register under section 415 of
the act and, thus, would not be a ``facility'' as that term would be
defined for the purpose of this rule. Under this definition, a facility
that packs or holds the animal food without any type of manufacturing/
processing would not be a supplier. Under this approach, a facility
would not be required to establish a supplier program for animal food
products that it only packs or distributes. For example, a receiving
facility might receive a raw material or ingredient from a distribution
center that receives the raw material or ingredient from a
manufacturing facility or a farm. The distribution center, which is the
immediate previous source of the raw material or ingredient, would not
be required to establish a supplier program and would not be considered
the supplier; rather the supplier would be the manufacturer or the farm
(which manufactured/processed the food or harvested the food that was
provided to the distribution center and subsequently to the receiving
facility). In such instance, if the receiving facility has identified a
significant hazard for the raw material or ingredient, and that hazard
is controlled by the supplier (the manufacturer or the farm), the
receiving facility would establish verification activities related to
the manufacturer or the farm that provided the raw material or
ingredient to the distribution center.
If a facility receives an ingredient from a supplier, but the
control of the hazard is by the supplier's supplier, under a potential
supplier verification program, the receiving facility would conduct
supplier verification activities that would include verifying that the
supplier has conducted appropriate verification that its supplier has
controlled the hazard, i.e., the receiving facility would review the
supplier's food safety records for its supplier's control of the
hazard. For example, if a feed mill is receiving animal protein from a
protein blender that receives meat and bone meal from a rendering
facility, the feed mill could conduct verification activities related
to the rendering plant controls at the rendering facility by reviewing
the supplier program of, and verification activities conducted by, the
protein blender for its supplier, the renderer (in addition to
verifying the protein blender's control of pathogens).
We understand that, particularly for RACs, there may be multiple
establishments, including cooperatives, packing houses, and
distributers, between a receiving facility and the establishment that
would be considered the supplier, which would make potential supplier
verification very challenging under certain circumstances. We request
comment on what verification activities would be appropriate for
receiving facilities to conduct, should a supplier verification program
be included in any final rule, when a raw material or ingredient passes
through more than one facility that would not be required to verify
control of hazards if supplier programs are limited to manufacturers/
processors. For example if a receiving facility is a feed mill that
receives oats from a distributor, who receives grains from a
cooperative, and neither the distributor nor the cooperative is
required to establish supplier controls for the farms, where the
hazards are being controlled, what supplier controls should be applied
for the grains coming from the farms? We request comment on whether and
how any potential supplier verification should address such situations.
In addition, we seek comment regarding whether (and, if so, how)
the final preventive controls rule should address the potential for
gaps in supplier controls when a hazard is controlled at Point A in the
supply chain and Point B in the supply chain is a facility that only
packs or holds
[[Page 58498]]
animal food, but does not manufacture/process animal food (and
therefore would not be required to have a supplier program) before
passing it on to Point C in the supply chain.
The potential supplier program would be included in the food safety
plan and, thus, would be prepared (or overseen) by a qualified
individual (see proposed Sec. 507.31(b)). A supplier program could be
established and maintained by a facility's corporate headquarters or
parent entity. The recordkeeping requirements would specify that
electronic records are considered to be onsite if they are accessible
from an onsite location, and we expect that many records for the
supplier program would be in electronic form (and thus easily
retrievable by a facility during an inspection).
Rather than specifically require a written list of approved
suppliers, the potential requirements would specify that the supplier
program be written, and include verification activities, as appropriate
to the hazard, and documentation of such activities, to ensure products
are received only from suppliers approved for control of the hazard(s)
in that raw material or ingredient (or, when necessary and appropriate,
on a temporary basis from unapproved suppliers whose raw materials or
ingredients the receiving facility subjects to adequate verification
activities before acceptance for use). Such a program could include,
for example, written procedures for approving suppliers, for approving
(or rejecting) specific raw materials and ingredients, and for
documenting that raw materials or ingredients are only received from
approved suppliers. The potential requirements would recognize that
there can be circumstances that would require a facility to receive raw
materials or ingredients on a temporary basis from an unapproved
supplier (e.g., if there is a disruption in delivery of raw materials
and ingredients from approved suppliers due to circumstances such as
localized flooding or malfunctioning equipment). We request comment on
examples of circumstances when it would be necessary and appropriate to
receive raw materials and ingredients on a temporary basis from an
unapproved supplier and on the types of verification activities that a
facility should conduct on animal food from an unapproved supplier.
The potential requirements would provide flexibility for the
verification activities that the receiving facility would conduct for
raw materials and ingredients. With one exception, the receiving
facility would have flexibility to select one or more of four possible
activities: (1) Onsite audit; (2) sampling and testing of the raw
material or ingredient, which could be conducted by either the supplier
or the receiving facility; (3) review by the receiving facility of the
supplier's relevant food safety records; and (4) other appropriate
supplier verification activities based on the risk associated with the
ingredient and the supplier. To determine which option is appropriate,
the receiving facility could consider (1) the severity of the hazards;
(2) where the preventive controls for those hazards are applied (such
as at the supplier or the supplier's supplier); (3) the supplier's
procedures, processes, and practices related to the safety of the raw
materials and ingredients; (4) applicable FDA food safety regulations
and information relevant to the supplier's compliance with those
regulations, including an FDA warning letter or import alert relating
to the safety of the animal food; (5) the supplier's animal food safety
performance history relevant to the raw materials or ingredients that
the receiving facility receives from the supplier, including available
information about results from testing raw materials or ingredients for
hazards, audit results relating to the safety of the animal food, and
responsiveness of supplier in correcting problems; and (6) any other
factors as appropriate and necessary, such as storage and
transportation. Thus, a receiving facility would have flexibility to
select a verification activity based on the circumstances.
The exception would be when there is a reasonable probability that
exposure to the hazard will result in serious adverse health
consequences or death to humans or animals. In this circumstance, under
the potential supplier program, the receiving facility would be
required to have documentation of an onsite audit of the supplier
before using the raw material or ingredient from the supplier and at
least annually thereafter. The potential requirement for an annual
audit is limited to when there is a reasonable probability that
exposure to the hazard will result in serious adverse health
consequences or death to humans or animals. Further, the receiving
facility could select less frequent audits or a different verification
activity, if it documented its determination that the less frequent
onsite auditing or other verification activity provides adequate
assurance that the hazards are controlled. The potential recordkeeping
requirements that would apply to audits would identify specific
information that the records must provide about the audit, including
the conclusions of the audit, but would not specify that the underlying
audit report is part of the required documentation of an audit.
A person who conducts an audit would need to be qualified to do so.
To be qualified, a person who conducts an audit (``qualified auditor'')
would be required to satisfy the criteria for a ``qualified
individual'' (a person who has successfully completed training in the
development and application of risk-based preventive controls
equivalent to that of an FDA-recognized standardized curriculum or is
otherwise qualified through job experience to develop and apply a food
safety system) and have technical expertise obtained by a combination
of training and experience appropriate to perform the auditing
function.
The potential supplier program would require the receiving facility
to know the FDA food safety regulations that apply to the supplier, and
relevant information about the supplier's compliance with those
regulations. The focus of section 418 of the FD&C Act is on preventing
food safety problems rather than on reacting to them. Section 418 of
the FD&C Act requires the owner, operator, or agent in charge of a
facility to establish and implement preventive controls to
significantly minimize or prevent known or reasonably foreseeable
hazards. By specifying that supplier verification activities are a
preventive control, section 418 requires the receiving facility to take
necessary actions to ensure that raw materials and ingredients are not
adulterated. To determine whether incoming raw materials and
ingredients are adulterated, a receiving facility would need to know
the regulatory framework that applies to the raw materials and
ingredients, and to have confidence that its supplier is complying with
that regulatory framework.
The potential supplier program would include provisions to address
non-conformance by a supplier. This potential requirement would not
prescribe when a particular corrective action (such as discontinuing a
supplier) is necessary. A facility could substitute an inspection
(whether by FDA or by the food safety authority of a country whose
animal food safety system FDA has officially recognized as comparable
or determined to be equivalent to that of the United States) for an
audit. Even though inspection procedures and audit procedures are not
identical, we tentatively conclude that a facility should have
flexibility to determine whether an inspection could substitute for an
audit based on characteristics such as the severity of
[[Page 58499]]
the hazard, how the supplier controls the hazard, and the supplier's
performance history. For example, a facility that receives animal feed
ingredients from a facility subject to the BSE feed regulations in 21
CFR 589.2000 may conclude that an FDA inspection for compliance with
the BSE regulations (concluding that no action is indicated) provides
adequate assurance that the facility is producing an animal food
ingredient in compliance with the requirements of applicable FDA food
safety regulations and is not adulterated under section 402 of the FD&C
Act. For additional discussion of our reasons for tentatively
concluding that it would be appropriate to substitute an inspection
(whether by FDA or by the food safety authority of a country whose food
safety system FDA has officially recognized as comparable or determined
to be equivalent to that of the United States) for an audit, see the
discussion in the proposed FSVP rule (78 FR 45730 at 45758). In
addition, we are asking for comment on whether it would be appropriate
to substitute an inspection in another country (Country A) for an audit
when, for example, it is the food safety authority of Country B (whose
food safety system FDA has officially recognized as comparable or
determined to be equivalent to that of the United States) that
conducted the inspection in Country A.
The potential requirements would provide for alternative
verification requirements when a supplier subject to the requirements
of section 418 of the FD&C Act is a qualified facility subject to the
requirements of proposed Sec. 507.7. Section 418 provides different
requirements for qualified facilities, which are reflected in the
different potential verification requirements for such facilities.
Although the potential requirements would allow a receiving facility to
conduct an alternative verification activity when the supplier is a
qualified facility, they would not require this.
Likewise, the potential requirements would provide for alternative
verification requirements when a supplier is a farm that would not be
subject to the requirements of proposed Sec. 112.4 regarding the raw
material or ingredient that the receiving facility receives from the
farm. Some of these farms would be not be subject to the requirements
of proposed Sec. 112.4 because they satisfy the criteria, in section
419(f) of the FD&C Act, for an exemption for direct farm marketing.
Other farms would not be subject to the requirements of proposed Sec.
112.4 because the crops they grow would not be covered by the proposed
produce safety rule, either based on the findings of a qualitative
assessment of risk associated with growing, harvesting, packing, and
holding of produce (see the discussion of this qualitative assessment
of risk in the 2013 proposed produce safety rule, 78 FR 3504 at 3508
and 3522-3529) or because they account for a very small percentage of
covered produce (see proposed Sec. 112.4 and the discussion at 78 FR
3504 at 3549). Although the potential requirements would allow a
receiving facility to conduct an alternative verification activity for
such farms, they would not require this. Although the potential
requirements would provide for alternative verification requirements
for farms that would not be subject to the produce safety rule, we
would not issue a final rule on such alternative verification
requirements until we issue the final produce safety rule.
D. Request for Additional Comment on Requirements To Address Conflicts
of Interest for Persons Conducting Verification Activities
In the 2013 proposed FSVP rule, we tentatively concluded that it
would be appropriate to address the independence of individuals
conducting verification activities (78 FR 45730 at 45759). We proposed
that an individual who conducts any verification activity must not have
a financial interest in the foreign supplier and payment must not be
related to the results of the activity, and provided that this would
not prohibit an importer, or the importer's employee, from conducting
the verification activity (proposed Sec. 1.506(g)). As discussed in
the 2013 proposed FSVP rule, we considered such requirements necessary
to prevent bias, or the appearance of bias, on the part of a person
conducting a verification activity (78 FR 45730 at 45759).
We request comment on whether we should include in the final
preventive controls rule requirements to address conflicts of interest
for individuals conducting verification activities and, if so, the
scope of such requirements. For example, should such requirements be
directed to a subset of persons who conduct verification activities
(such as auditors) or should they be directed more broadly? Would a
requirement such as in the 2013 proposed FSVP rule be appropriate, or
would some other requirement be more appropriate (such as a requirement
that persons be free of conflicts of interest that are relevant to the
outcome of the activity)? What would constitute a financial interest in
a company sufficient to constitute a conflict of interest for a person
conducting a supplier verification activity (e.g., conducting an audit
of that company or conducting laboratory tests of that company's food)?
XIV. Potential Requirements for the Hazard Analysis To Address
Economically Motivated Adulteration
A. Our Request for Comment on Whether the Final Rule Should Address
Economically Motivated Adulteration
In the 2013 proposed rule for preventive controls, we announced our
intent to implement the statutory requirements for hazards that may be
intentionally introduced, including by acts of terrorism, in a separate
rulemaking rather than include them in the requirements for hazard
analysis and risk-based preventive controls (78 FR 64736 at 64745). We
tentatively concluded that intentional hazards, which are not addressed
in traditional HACCP or other food safety systems, likely will require
different kinds of controls and would be best addressed in a separate
rulemaking. However, we also acknowledged that some kinds of
intentional adulterants could be viewed as reasonably likely to occur,
e.g., in foods concerning which there is a widely recognized risk of
economically motivated adulteration in certain circumstances. We
provided an example of this kind of hazard, i.e., the addition of the
chemical melamine to certain food products, apparently to enhance the
measured protein content and/or perceived quality of the product. We
requested comment on whether to include potential hazards that may be
intentionally introduced for economic reasons. We also requested
comment on when an economically motivated adulterant can be considered
reasonably likely to occur.
When we developed the 2013 proposed intentional contamination rule,
we tentatively concluded that economically motivated adulteration would
be best addressed through the approach in the preventive controls rules
for human food and for animal food (including hazard analysis,
preventive controls, monitoring, corrective action, verification, and
recordkeeping) rather than through the vulnerability assessment-type
approach for intentional adulteration, where the intent is to cause
wide-spread public health harm, such as acts of terrorism (see the 2013
proposed intentional adulteration rule, 78 FR 78014 at 78020). We also
explained our view that the primary purpose of economically motivated
adulteration is to obtain economic gain rather than to impact
[[Page 58500]]
public health, although public health harm may occur (78 FR 78014 at
78020).
B. Comments on Economically Motivated Adulteration
Some comments oppose including requirements directed to
economically motivated adulteration in the preventive controls rule.
These comments assert that the vast majority of economically motivated
adulterants affect quality and value rather than safety. These comments
also point out that the majority of food products could, in theory, be
subject to economically motivated adulteration but that it would be
difficult to determine if such adulteration is reasonably foreseeable.
One comment recommends that we draw a clear distinction between hazards
that are intentionally introduced and those that are not. Another
comment expresses the view that food fraud is fundamentally different
from both food safety and food defense. However, some comments do
support including ``expected intentional adulterants'' in the
preventive controls rule.
C. Potential Requirements To Address Economically Motivated
Adulteration
Taking into account the comments we have reviewed so far for the
proposed preventive controls rules for human food and for animal food,
we are providing an opportunity for public comment on a potential
requirement for the hazard identification to consider hazards that may
be intentionally introduced for purposes of economic gain (see proposed
Sec. 507.33(b)(2)(iii) in proposed subpart C). In this section of this
document, we are reopening the comment period with respect to our
previous request for comment on whether to include potential hazards
that may be intentionally introduced for economic reasons. We are
seeking comment on whether this preventive controls rule would be the
most appropriate rule to address FSMA's requirements to address hazards
that may be intentionally introduced (for purposes of economic gain)
and, if so, what (if any) modifications to the proposed regulatory text
would be appropriate. We note that the preliminary regulatory impact
analysis (PRIA) that presents the benefits and costs of this proposed
rule (Ref. 1) describes certain assumptions we are making about the
preventive controls, and their implementation, that would be
established and implemented by a facility that identifies a potential
hazard that may be intentionally introduced for economic reasons as a
significant hazard. We are seeking comment on alternative ways to
control such hazards.
Under the definitions that would be established in the rule, a
hazard would be an agent that is reasonably likely to cause illness or
injury in the absence of its control. Thus, the focus of the potential
requirement would be on those economically motivated adulterants that
are reasonably likely to cause illness or injury in the absence of
their control, not on economically motivated adulterants that solely
affect quality and value with little or no potential for public (human
or animal) health harm.
We believe that it is practicable to determine whether economically
motivated adulteration is reasonably foreseeable. Importantly, we would
not expect facilities to consider hypothetical economically motivated
adulteration scenarios for their animal food products. As discussed in
the 2013 proposed intentional adulteration rule, we would expect
facilities to focus on circumstances where there has been a pattern of
such adulteration in the past, suggesting a potential for intentional
adulteration even though the past occurrences may not be associated
with the specific supplier or the specific food product (78 FR 78014 at
78027). For example, in the 2013 proposed rule for preventive controls
we discussed a widespread incident of economically motivated
adulteration in which two ingredient suppliers added melamine, a
nitrogen-rich industrial by-product (a non-protein nitrogen), to wheat
gluten and rice protein concentrate to increase the apparent protein
content (78 FR 64736 at 64746). The wheat gluten was imported by a U.S.
broker and sold to U.S. pet food manufacturers and at least one
distributor who then sold it to other pet food manufacturers. The
melamine adulterated products later made their way into food for swine,
poultry, and fish. This adulteration resulted in significant public
health consequences for animals as well as concerns for human health
from products produced from swine, poultry, and fish that had consumed
melamine contaminated foods (72 FR 30014).
In light of this incident, a prudent person would include in its
hazard analysis the potential for melamine to be an economically
motivated adulterant in its animal food products when using certain
protein ingredients for animal food and, based on the outcome of its
hazard analysis, determine whether melamine is a hazard that must be
addressed in the food safety plan.
There are other well-known substances that have been economically
motivated adulterants and have potential to cause public (human and
animal) health harm. The U.S. Pharmacopeial Convention (USP) has a free
on-line food fraud database (Ref. 19) and a recent report from the
Congressional Research Service provides additional information on
economically motivated adulteration of food and food ingredients (Ref.
20).
XV. Provisions for Withdrawal of an Exemption for a Qualified Facility
A. 2013 Proposed Provisions for Withdrawal of an Exemption for a
Qualified Facility
In the 2013 proposed rule for preventive controls, we explained the
provisions of FSMA that establish criteria for a facility to be a
qualified facility, establish an exemption for qualified facilities,
establish requirements for qualified facilities, and provide that we
may withdraw the exemption otherwise granted to qualified facilities in
specified circumstances (section 418(l) of the FD&C Act; see 78 FR
64736 at 64743). We proposed to establish:
Definitions relevant to these provisions (proposed Sec.
507.3);
An exemption from the requirements for hazard analysis and
risk-based preventive controls for qualified facilities (proposed Sec.
507.5(d));
Requirements for qualified facilities (proposed Sec.
507.7); and
Procedural requirements that would govern our withdrawal
of an exemption for a qualified facility (proposed subpart D; the 2013
proposed withdrawal provisions) (see 78 FR 64736 at 64762, 64765, and
64810).
The 2013 proposed withdrawal provisions would:
Specify the circumstances under which we would withdraw an
exemption for a qualified facility (proposed Sec. 507.60);
Establish procedures for us to issue an order to withdraw
the exemption, including information that would be in the order
(proposed Sec. Sec. 507.62 and 507.65);
Establish procedures whereby a qualified facility may
submit a written appeal of our order to withdraw an exemption (proposed
Sec. 507.67 and 507.69);
Establish procedures for appeals, hearings, and decisions
on appeals and hearings (proposed Sec. Sec. 507.71, 507.73, 507.75,
and 507.77); and
Specify the circumstances in which an order to withdraw an
exemption is revoked (proposed Sec. 507.80).
[[Page 58501]]
B. Proposed Clarification of What FDA Will Do Before Issuing an Order
and Proposed Mechanism for Re-Instating an Exemption
For a full discussion on the comments received for provisions on
withdrawal of an exemption for a qualified facility under the 2013
proposed rule for preventive controls for human food, see section
XIII.B of the preamble for the supplemental notice of proposed
rulemaking for preventive controls for human food published elsewhere
in this Federal Register. See the revised regulatory text for proposed
subpart D for the full text of the proposed requirements.
C. Proposed Revisions to the Content of an Order To Withdraw an
Exemption
Based on comments reviewed to date for the proposed preventive
controls rule for human food, which appear relevant to animal food, in
this section of this document, we are reopening the comment period with
respect to proposed Sec. 507.65(d).
Some comments received under the 2013 proposed rule for preventive
controls for human food recommend that the order explicitly state that
the facility has the option to either comply with the order or appeal
the order (with a request for an informal hearing) within 10 calendar
days.
We tentatively conclude that it would be useful for the order to
itself specify the two options that a facility has upon receipt of the
order, even though the order would otherwise include this information
(because the order will contain the full text of the withdrawal
provisions). Therefore, we are proposing to revise the requirements for
the contents of an order to explicitly mention these two options. See
the revised regulatory text of proposed Sec. 507.65(d).
D. Proposed Revisions to the Timeframes for a Facility To Comply With,
or Appeal, an Order
In this section of this document, we are reopening the comment
period with respect to the timeframes in proposed Sec. Sec. 507.65(d)
and 507.67(a) and (c).
1. Comments
Some comments received under the 2013 proposed rule for preventive
controls for human food ask us to specify that a facility's timeframe
for taking action begins when the facility receives the order, not when
we issue the order. Other comments address the timeframes for a
facility to compile information needed to appeal an order for
withdrawal. These comments assert that the proposed timeframe of 10
days is insufficient, and recommend timeframes such as 30 days or 90
days.
Some comments contrast the proposed 60-day timeframe to comply with
the requirements for hazard analysis and risk-based preventive controls
when a facility loses its exemption as a qualified facility with the
timeframe that a facility would have to comply with these requirements
when the final rule first becomes effective. As discussed in the 2013
proposed rule for preventive controls, we proposed compliance dates
that would be 2 years and 3 years after the date of the final rule for
small and very small businesses, respectively (78 FR 64736 at 64751).
The comments assert that these two situations are parallel, because a
qualified facility that has had its exemption withdrawn would be coming
into compliance with the full requirements for hazard analysis and
risk-based preventive controls for the first time. These comments
recommend that we change the timeframes in the 2013 proposed withdrawal
provisions to better align with the compliance dates contemplated by
the proposed rule and by FSMA for small and very small businesses. Some
of the comments recommend that a small business have 6 months, and that
a very small business have 18 months, to comply with the order. Other
comments recommend that any business (whether small or very small) have
two years to comply with the order. Some of these comments recommend
that the timeframe be tied to the date of the final determination
rather than to the date of the order.
2. Proposed Revisions to Timeframes
We tentatively conclude that the nature of what a facility would
need to do to comply with an order, i.e., comply with the full
requirements for hazard analysis and risk-based preventive controls--
makes the timeframes in the 2013 proposed withdrawal provisions
insufficient. However, it is relevant that in contrast to the general
compliance dates, the proposed withdrawal provisions would only apply
when a significant public health (human and animal) concern has been
identified for a particular facility.
We also tentatively conclude that it is appropriate to link the
timeframe for compliance to the date of receipt of the order, rather
than to the date the order was issued. Doing so would be consistent
with our other administrative procedures, such as appeal of an order
for administrative detention (Sec. 1.402).
Taking into account the comments reviewed so far for the proposed
rule for preventive controls for human food, which appear relevant to
animal food, we are proposing to require that a facility comply with an
order to withdraw an exemption within 120 days of the date of receipt
of the order. See the revised regulatory text for proposed Sec. Sec.
507.65(d) and 507.67(a) and (c).
XVI. Definition of Very Small Business
A. The 2013 Proposed Options for Definition of Very Small Business
We proposed three options for the definition of a very small
business based on total annual sales of animal food, adjusted for
inflation: Option 1, $500,000; Option 2, $1,000,000; and Option 3,
$2,500,000. The 2013 proposed rule for preventive controls contained
several provisions relevant to very small businesses, including
exemptions from subpart C in Sec. Sec. 507.5(e) and 507.5(f) for very
small (and small) facilities engaged only in specific types of on-farm
activities involving low-risk activity/animal food combinations, the
exemption in Sec. 507.5(d) and requirements in Sec. 507.7 for a very
small business as a qualified facility, and extended time to comply
with the rule. In defining a very small business, we took into
consideration the study of the food processing sector required by
section 418(l)(5) of the FD&C Act (``Food Processing Sector Study''
(Ref. 21); see 78 FR 64736 at 64758-64759). In the 2013 proposed rule
for preventive controls, we requested comment regarding the three
proposed options for the definition of ``very small business.'' We also
requested comment on whether a dollar amount of sales that is more
than, or less than, the $500,000; $1,000,000; or $2,500,000 amounts
would be appropriate.
B. Comments on the 2013 Proposed Options for Definition of Very Small
Business
Comments support a variety of dollar limits of total annual sales
of animal food for defining a very small business, including each of
the three proposed options ($500,000, $1,000,000, and $2,500,000) as
well as other dollar limits that we did not include as proposed options
(e.g., less than $10,000). Some comments assert that very small
facilities will incur a large portion of the costs associated with
implementing the 2013 proposed rule for preventive controls rule
because very small facilities lack experience with HACCP-based models.
Some comments support defining a very small business as one with
total annual animal food sales up to $2,500,000. Some of these comments
express concern that using lower dollar
[[Page 58502]]
sales amounts to define a very small business would discourage growth
of very small processing facilities (especially those co-located on a
farm), would unfairly burden very small facilities, and could cause
them to fail due to the estimated high cost of compliance; whereas
setting a higher dollar sales amount would encourage growth, innovation
and diversification. Some of these comments note that adopting the
threshold of $2,500,000 would establish that the full preventive
controls requirements would apply to the businesses that produce the
vast majority of animal food products and that modified requirements
would apply to smaller businesses that represent the majority of
producers but the minority of the animal food supply.
Other comments support no amount of annual animal food sales for
defining very small business stating that the requirements should apply
uniformly to all facilities. Some comments state that even a $2,500,000
threshold would result in very few of certain types of animal food
facilities qualifying as a very small business.
C. Proposed Revisions to the Definition of Very Small Business
In this supplemental notice of proposed rulemaking, we are
proposing the definition of very small business as a business that has
less than $2,500,000 in total annual sales of animal food adjusted for
inflation. The statutory construct does not prevent us from
establishing a definition for very small business that would include
more facilities than those that would be included under the statutory
provision that considers sales to qualified end-users (section
418(l)(1)(C) of the FD&C Act). Section 418(n)(1)(B) of the FD&C Act
directs FDA to define the term ``very small business'' for the purposes
of determining whether a facility is a ``qualified facility'' eligible
for modified requirements. Further, section 418(n)(1)(B) requires us to
consider the Food Processing Sector Study for the purpose of defining
``very small business.'' FDA notes that section 418 of the FD&C Act
does not otherwise limit how FDA may define ``very small business.''
We tentatively conclude that it is not necessary for the dollar
limit in the definition of ``very small business'' to be $500,000 or
less to protect public health (human and animal). In the 2013 proposed
rule for preventive controls, we estimated the number of facilities
that would be affected by the size specified in the definition of
``very small business.'' The size specified in the definition of ``very
small business'' would affect the compliance dates, the exemptions for
qualified facilities, and the exemptions for on-farm low-risk packing
and holding activity/animal food combinations and on-farm low-risk
manufacturing/processing activity/animal food combinations (proposed
Sec. Sec. 507.5(d), (e), and (f), respectively) (see 78 FR 64736 at
64762-64763). As a group, businesses with less than $2,500,000 in total
annual sales of animal foods produce less than two percent of all
animal food produced in the United States when measured by dollar
value. (In the 2013 proposed rule, this was stated as businesses with
less than $2,500,000 in as total annual sales of animal food produce
less than 20.8 percent of all pet food and animal feed produced in the
United States when measured by dollar value (78 FR 64736 at 64760).
This was an error and should have said less than 2 percent of all pet
food and animal feed produced in the United States when measured by
dollar value.) We acknowledge that this estimate of all animal food
produced in the United States is higher than the estimates for lower
dollar limits (less than one percent of all animal food produced in the
United States, or less than one-half of one percent of all animal food
produced in the United States, for limits of $1,000,000 or $500,000,
respectively). Regardless, under the revised definition, the businesses
that would be exempt from the requirements for hazard analysis and
risk-based preventive controls would represent a small portion of the
potential risk of foodborne illness.
We tentatively conclude that the definition of very small business
should exempt from the rule only a small percent of animal food to
minimize the risk of foodborne illness and, thus, are proposing a very
small business definition of $2,500,000, which would exempt less than
two percent of the dollar value of animal food produced in the United
States. We request comment on this tentative conclusion and whether we
should consider other dollar limits for very small business.
A dollar limit in the definition of ``very small business'' greater
than $500,000 would not necessarily exempt those companies whose
practices would be most improved by complying with the requirements for
hazard analysis and risk-based preventive controls. The Food Processing
Sector Study (Ref. 21) concluded that there was no consistent pattern
across food categories, including the pet food and animal feed
categories, in terms of which sizes of establishments contribute most
to foodborne illness risk (78 FR 64736 at 64758). Moreover, the
facilities that would be classified as qualified facilities would be
subject to modified requirements (see proposed Sec. 507.7).
Furthermore, all facilities that would be exempt from the requirements
for hazard analysis and risk-based preventive controls would continue
to be subject to the prohibitions in the Federal Food, Drug, and
Cosmetic Act against causing animal food to be adulterated or
misbranded and against distributing such animal food, and to inspection
by FDA.
We are not proposing that the definition of ``very small business''
consider number of employees as well as dollar limits, be based on
number of employees for consistency with the definition of ``small
business,'' or be based on volume of animal food sold rather than on
dollar limits associated with sales of animal food. There are two
alternative sets of criteria to be a qualified facility. The criteria
in section 418(l)(1)(C) of the FD&C Act are set out with regard to
sales. We believe it is appropriate for the other criteria (related to
being a ``very small business'') similarly to be related to sales. As
discussed in the 2013 proposed rule for preventive controls, we
proposed number of employees for the definition of ``small business''
in part because it would be the same definition for small business as
that which has been established by the U.S. Small Business
Administration under 13 CFR 121 for most food manufacturers. We
continue to believe that the proposed definition of ``small business,''
based on number of employees, is appropriate.
We are not proposing that the definition of ``very small business''
consider the risk associated with the animal food manufactured,
processed, packed, or held by the facility. The description ``very
small'' addresses size of a business, not risk associated with animal
food that the facility manufactures, processes, packs, or holds.
XVII. Other New and Revised Proposed Provisions
A. Proposed New Definitions
1. Proposed Definition of ``Pathogen''
In the 2013 proposed rule for preventive controls for food for
animals, we proposed to define ``environmental pathogen'' to mean a
microorganism that is of animal or human health significance and is
capable of surviving and persisting within the manufacturing,
processing, packing, or holding environment. Variations of the phrase
``microorganism of animal or human health significance'' appear in
several places in the 2013 proposed
[[Page 58503]]
rule. To both simplify the regulations and use the same term (i.e.,
``pathogen'') when we mean a microorganism of animal or human
significance, we are proposing to define the term ``pathogen'' to mean
a microorganism that is of public (human or animal) health significance
and to replace variations of the phrase ``microorganism of animal or
human health significance'' with ``pathogen'' throughout the
regulations.
2. Proposed Definition of ``You''
We acknowledge the potential for confusion if the phrase ``owner,
operator, or agent in charge'' applies to both plant management and
operators in proposed subpart B and to the ``owner, operator, or agent
in charge of a facility'' in proposed subpart C. Most of the provisions
of proposed subpart B do not specify the role of ``plant management''
or the ``operator'' of a plant or establishment. To prevent confusion,
we tentatively conclude it is prudent to retain terms such as ``plant
management'' and ``operator'' in proposed subpart B.
However, we tentatively conclude that we can simplify the
regulations directed to the ``owner, operator, or agent in charge of a
facility'' in provisions in subparts A, C and D by using pronouns,
without creating confusion, if we (1) define the term ``you'' to mean,
for purposes of part 507, the owner, operator, or agent in charge of a
facility and (2) limit use of the term ``you'' to provisions in
proposed subparts A, C and D. See the revised regulatory text for the
definition of you (in proposed Sec. 507.3) and its use throughout
revised subpart C.
3. Proposed Definition of ``Significant Hazard''
As discussed in section XI.C, we are proposing to delete the
proposed definition ``hazard reasonably likely to occur'' and instead
establish a definition for ``significant hazard.'' See the revised
regulatory text in proposed Sec. 507.3.
4. Proposed Definition of ``Known or Reasonably Foreseeable Hazard''
As discussed in section XI.C, we are proposing to delete the
proposed definition ``reasonably foreseeable hazard'' and instead
establish a definition for ``known or reasonably foreseeable hazard.''
See the revised regulatory text in proposed Sec. 507.3.
5. Potential Definitions of ``Qualified Auditor,'' ``Receiving
Facility,'' and ``Supplier''
As discussed in section XIII.C, we are providing an opportunity for
public comment on potential requirements for a supplier program. If
such requirements are included in a final rule, we would establish
definitions for three terms used in the potential requirements for a
supplier program, i.e., ``qualified auditor,'' ``receiving facility,''
and ``supplier.'' See the proposed regulatory text in proposed Sec.
507.3.
B. Proposed Revisions to Definitions
In the 2013 proposed rule for preventive controls, we proposed to
establish several new definitions.
1. Revised Definition of ``Hazard'' and ``Reasonably Foreseeable
Hazard''
Some comments received under the 2013 proposed rule for preventive
controls for human food recommended that we include radiological
hazards as a subset of chemical hazards in the definition ``hazard.''
Although radiological hazards would not be common, we believe that
facilities in the past have considered them as chemical hazards when
conducting a hazard analysis for the development of HACCP plans. The
revised regulatory text uses the phrase ``chemical (including
radiological)'' in the definition of ``hazard'' and as applicable
throughout the regulations. As a conforming change, we are proposing to
revise the definition of ``reasonably foreseeable hazard'' to mean a
potential biological, chemical (including radiological), or physical
hazard that may be associated with the facility or the food.
2. Revised Definition of Environmental Pathogen
We proposed to define the term ``environmental pathogen'' to mean a
microorganism that is of public (human or animal) health significance
and is capable of surviving and persisting within the manufacturing,
processing, packing, or holding environment. We identified Salmonella
spp. and Listeria monocytogenes as examples of environmental pathogens.
There was some concern that our proposed definition of ``environmental
pathogen'' would capture organisms such as pathogenic sporeformers
whose presence in and of itself would not constitute a risk to public
(human or animal) health.
We are proposing to revise the definition of an environmental
pathogen to mean a pathogen capable of surviving and persisting within
the manufacturing, processing, packing, or holding environment such
that animal food may be contaminated and may result in foodborne
illness if that animal food is consumed (or in the case of pet food,
handled by a human) without treatment at the facility to significantly
minimize the environmental pathogen. The revised definition of
``environmental pathogen'' would specify that an environmental pathogen
does not include the spores of pathogenic sporeformers and, thus,
recognizes that consumption of animal food contaminated by the spores
of a pathogenic sporeformer that is in the environment may not result
in foodborne illness. For example, if animal food is contaminated with
spores of Clostridium botulinum, the microorganism would not produce
the botulinum toxin that causes illness unless these spores are subject
to conditions that allow them to germinate into vegetative cells that
produce the toxin. Pathogenic sporeformers are normally present in
animal foods, and unless the foods are subjected to conditions that
allow multiplication, they present minimal risk of causing illness.
C. Proposed Editorial Changes
The revised regulatory text includes several changes that we are
making to make the requirements more clear and improve readability. We
summarize the principal editorial changes in Table 8.
Table 8--Proposed Editorial Changes
------------------------------------------------------------------------
Designation in the revised
regulatory text (Proposed Proposed revision Explanation
Sec. )
------------------------------------------------------------------------
Throughout part 507......... Substitute the term For the purposes of
``adequate'' for part 507, there is
the term no meaningful
``sufficient''. difference between
``adequate'' and
``sufficient.'' We
proposed a
definition of
``adequate'' but
did not propose to
define
``sufficient.'' We
tentatively
conclude that the
regulations will be
clearer if we use
the single term
``adequate''
throughout the
regulations.
[[Page 58504]]
Throughout subparts A, C, Substitute the Improve clarity and
and D. defined term readability.
``you'' for
``owner, operator,
or agent in charge
of a facility''.
507.31...................... Redesignate the Accommodate
section number from insertions of new
the original Sec. 507.28 to
section number in subpart B.
the 2013 proposed
preventive controls
rule (proposed
507.30).
507.31(d)................... Specify that the Distinguish the
food safety plan is requirements for
a record that is the contents of the
subject to the food safety plan
requirements of from implementation
subpart F within records, which
the requirements continue to be
for the food safety listed in Sec.
plan (Sec. 507.55.
507.31) rather than
together with the
requirements for
other records
required by the
rule (Sec.
507.55).
507.33(b)................... Reordered the We tentatively
provisions in conclude that it is
paragraph (b). more logical to
specify what
hazards must be
considered (i.e.,
biological,
chemical (including
radiological), and
physical) before
specifying the
reasons for how the
hazards could get
into the food
products (i.e.,
naturally
occurring,
unintentionally
introduced, or
intentionally
introduced for
purposes of
economic gain).
507.36...................... Shorten the title Simplify the
from ``Preventive presentation of the
controls for requirements and
hazards that are conform with the
reasonably likely proposed deletion
to occur'' to of the term
``Preventive ``hazards that are
Controls''. reasonably likely
to occur''.
507.36(c)(1)................ Rearrange the It is more logical
requirements for to place these
(i) parameters requirements with
associated with the process controls
control of the since their
hazard and (ii) the parameters and
maximum or minimum their values are
value, or associated with
combination of process controls.
values, to which
any biological,
chemical, or
physical parameter
must be controlled
to be associated
with process
controls rather
than be a
standalone
requirement.
507.36(c)(2) and 507.42(c).. Move requirements Improve clarity and
for corrections for readability.
sanitation controls
from the
requirements for
preventive controls
(proposed Sec.
507.36) to the
requirements for
corrective actions
(proposed Sec.
507.42).
507.38...................... Shorten the title Simplify the
from ``Recall plan presentation of the
for animal food requirements and
with a hazard that conform with the
is reasonably proposed deletion
likely to occur'' of the term
to ``Recall plan''. ``animal food with
a hazard that is
reasonably likely
to occur''.
507.40...................... Redesignate the Accommodate
section number from insertions of new
the original Sec. 507.37
section number in (supplier program)
the 2013 proposed and new Sec.
preventive controls 507.39 (preventive
rule (proposed Sec. control management
507.39) and components) and
modify the language. reword to more
closely match the
statutory language.
507.45, 507.47, 507.49, and Move the more Improve clarity and
507.50. extensive readability.
verification
requirements for
validation,
implementation and
effectiveness, and
reanalysis from the
single proposed
section (proposed
Sec. 507.45) to
separate sections
(proposed Sec.
Sec. 507.47,
507.49, and 507.50,
respectively).
507.50(a)(4)................ Revise the Simplify the
requirements for presentation of
reanalysis of the requirements and
food safety plan reduce redundancy
after an in regulatory text
unanticipated event for inter-related
in which a requirements.
preventive control
is not properly
implemented to
refer to the
requirements for
corrective actions
in light of such an
event rather than
repeat the full
text of those
requirements for
corrective actions.
507.50(c)................... Specify ``document Improve clarity and
the basis for the readability.
conclusion that no
revisions are
needed'' rather
than ``document the
basis for the
conclusion that no
additional or
revised preventive
controls are
needed''.
507.50(e)................... Specify ``You must Improve clarity by
conduct a specifying what the
reanalysis of the owner, operator, or
food safety plan agent in charge of
when FDA determines the facility must
it is necessary to do in certain
respond to new circumstances
hazards and rather than what
developments in FDA may require.
scientific
understanding''
rather than ``FDA
may require a
reanalysis of the
food safety plan to
respond to new
hazards and
developments in
scientific
understanding.''.
507.55...................... Change the title Accurately reflect
from ``Records the nature of the
required for listed records
subpart C'' to after moving
``Implementation recordkeeping
records''. requirements for
the food safety
plan to Sec.
507.31.
507.55(a)(3)(ii) and (iii).. Add ``verification Distinguish these
of'' in front of requirements for
``monitoring'' and records applying to
``corrective ``verification of
actions''. monitoring'' and
``verification of
corrective
actions'' from
other requirements
for ``records of
monitoring'' and
``records of
corrective
actions''.
------------------------------------------------------------------------
[[Page 58505]]
D. Proposed Conforming Change to Proposed Part 117
As discussed in section IX, we are proposing a conforming change to
proposed part 117, the preventive controls rule for human food. We are
proposing to add Sec. 117.95 to proposed subpart B that would add
current good manufacturing practice requirements that would apply to
human food manufacturers/processors when by-products from human food
production are packed and held for animal food.
XVIII. Preliminary Regulatory Impact Analysis
A. Overview
FDA has examined the impacts of this proposed rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). FDA has developed a PRIA that presents the benefits and costs
of this proposed rule (Ref. 1). FDA believes that the proposed rule
will be a significant regulatory action as defined by Executive Order
12866. FDA requests comments on the PRIA.
The summary analysis of benefits and costs included in this
document is drawn from the detailed PRIA (Ref. 1) which is available at
http://www.regulations.gov (enter Docket No. FDA-2011-N-0922), and is
also available on FDA's Web site at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
B. Regulatory Flexibility Act
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because many small businesses will need to implement
a number of new preventive controls, FDA acknowledges that the final
rules resulting from this proposed rule will have a significant
economic impact on a substantial number of small entities.
C. Small Business Regulatory Enforcement Fairness Act of 1996
The Small Business Regulatory Enforcement Fairness Act of 1996
(Pub. L. 104-121) defines a major rule for the purpose of congressional
review as having caused or being likely to cause one or more of the
following: An annual effect on the economy of $100 million or more; a
major increase in costs or prices; significant adverse effects on
competition, employment, productivity, or innovation; or significant
adverse effects on the ability of United States-based enterprises to
compete with foreign-based enterprises in domestic or export markets.
In accordance with the Small Business Regulatory Enforcement Fairness
Act, the Office of Management and Budget (OMB) has determined that this
proposed rule, if finalized, would be a major rule for the purpose of
congressional review.
D. Unfunded Mandates Reform Act of 1995
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $144 million, using the most current (2013) Implicit
Price Deflator for the Gross Domestic Product. FDA expects that the
proposed rule will result in a 1-year expenditure that would exceed
this amount.
XIX. Paperwork Reduction Act of 1995
This supplemental notice of proposed rulemaking contains
information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501-3520). A description of these provisions is
given in the Description section with an estimate of the annual
recordkeeping, reporting, and third-party disclosure burden. Included
in the estimate is the time for reviewing instructions, searching
existing data sources, gathering and maintaining the data needed, and
completing and reviewing each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Current Good Manufacturing Practice and Hazard Analysis and
Risk-Based Preventive Controls for Food for Animals.
Description: FDA is proposing to amend its 2013 proposed rule for
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals to add requirements for
domestic and foreign facilities that are required to register under
section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
The amendments include potential provisions that would require
facilities to establish and implement, as necessary, the following
verification activities: product testing, environmental monitoring, and
a supplier program. In addition, FDA is amending its proposed rule to
require that the hazard analysis (HA) and risk-based preventive
controls for animal food take into account the possibility of
economically motivated adulteration (EMA) of animal food.
Description of Respondents: Section 418 of the FD&C Act is
applicable to the owner, operator or agent in charge of a food facility
required to register under section 415 of the FD&C Act. Generally, a
facility is required to register if it manufactures, processes, packs,
or holds food for consumption in the United States.
The information collection estimate for the supplemental proposal
for preventive controls for food for animals may increase if the
potential requirements (the addition of provisions for product testing,
environmental monitoring, a supplier program, and identifying and
evaluating any potential hazards caused because of economically
motivated adulteration) are finalized. Additionally, proposed labeling
requirements have been added for animal food, including labeling of
human food by-products used for animal food.
Information Collection Burden Estimate
Supplemental Notice of Proposed Rulemaking Burden
Recordkeeping Burden
FDA estimates the burden for this information collection, should
the potential provisions in this proposed rule be included in any final
rule, as follows:
[[Page 58506]]
Table 9--Estimated Potential Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total annual burden per Capital costs Operating and
21 CFR part 507, subpart C record- records per records record-keeping Total hours \2\ maintenance
keepers \1\ record-keeper (in hours) costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potential product testing written 20 0.33 6.6 5.33 35 .............. [sup1]
procedures (small pet food $131,400
manufacturers) (potential Sec.
507.49(a)(2))..........................
Potential product testing written 10 0.33 3.3 5.33 18 .............. ( [sup4] )
procedures (small ingredient
manufacturers) (potential Sec.
507.49(a)(2))..........................
Potential environmental monitoring 105 0.33 35 5.33 187 .............. [sup2] 368,200
written procedures (potential Sec.
507.49(a)(3))..........................
Potential supplier program written 4,325 0.33 1,428 5.33 7,611 $4,018,100 [sup2] 162,200
procedures (potential Sec.
507.37(a)(2))..........................
Sec. 507.37(c)(3) and (c)(4) qualified 134 0.5 67 2 134 .............. ..............
or exempt suppliers' assurances........
Sec. 507.33(b)(2)(iii) written HA for 4,325 0.33 1,428 3 4,284 $627,800 [sup2]
EMA.................................... 4,227,300
Sec. 507.33(b)(2)(iii) updating 4,325 0.5 2,163 0.1 216 ( [sup5] ) ( [sup5] )
written HA for EMA.....................
Sec. 507.49(a)(4)(ii) verification-- 952 12 11,424 0.5 5,712 .............. [sup1] 258,400
review of records......................
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr -----------------------------------------------------------------------------------------------
Total............................... .............. .............. .............. .............. 18,197 $4,645,900 5,147,500
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ From 2014 PRIA (Ref. 1).
\2\ These numbers were obtained from FDA economics staff.
\3\ Costs for product testing and EMA are broken out across 2 rows.
\4\ Included in row 1 costs.\3\
\5\ Included in row 6 costs.\3\
Table 9 indicates the potential hourly and cost burden for
complying with the supplemental notice of proposed rulemaking: i.e.,
product testing, environmental monitoring, the supplier program,
economically motivated adulteration, and verification review of
records.
Should the potential provisions in this proposed rule be included
in any final rule, we estimate 8,130 facilities would be subject to
subpart C--Hazard Analysis and Risk-Based Preventive Controls. We also
estimate the number of non-qualified facilities would be 4,325 and the
number of qualified facilities would be 3,805.
Should the potential product testing provision be included in a
final rule, product testing would be an activity for verification of
implementation and effectiveness FDA estimates that 102 non-qualified
small pet food manufacturers and 67 non-qualified small ingredient
suppliers exist. The Eastern Research Group (ERG) cost model reports
that only these categories contain facilities subject to Subpart C that
do not currently test animal food products for Salmonella but that
might do so under proposed Sec. 507.49(a)(2). The ERG also estimates
that 20% of facilities are out of perfect compliance and would need to
develop and record written procedures. In Table 9, to obtain the amount
for total records for product testing for small pet food manufacturers,
20 small pet food manufacturers (recordkeepers) (20% of 102) multiplied
by 0.33 records per recordkeeper (1 written procedure during the 3-year
PRA approval period) equals 6.6 total records annually. Then, to obtain
total hours, 6.6 total records multiplied by 5.33 average burden per
record in hours (time needed according to FDA subject matter experts
(SMEs)) equals 35 hours annually. For small ingredient manufacturers
(Table 9, row 2), to obtain the total number of records, 10
recordkeepers (20% of 67 rounded down to 10) multiplied by 0.33 records
per recordkeeper (1 written procedure during the 3-year PRA approval
period) equals 3.3 total records. Then, to obtain the total number of
hours, 3.3 total records multiplied by 5.33 average burden per record
in hours (time needed according to FDA SMEs) equals 18 hours annually.
Should the potential environmental monitoring provision be
finalized, FDA estimates 105 recordkeepers would need to include
environmental monitoring procedures as a verification activity,
creating one written procedure per facility. In Table 9, to obtain the
number of annual records, 105 recordkeepers multiplied by 0.33
environmental monitoring procedures per facility (over 3 years of the
PRA approval period) equals 35 annual records. Then, to obtain the
total number of hours, 35 total records multiplied by 5.33 average
burden per record in hours (time needed according to FDA SMEs) equals
187 total hours annually.
[[Page 58507]]
Should the potential supplier program previously discussed be
included in a final rule, a receiving facility establish and implement
a risk-based supplier program for those raw materials and ingredients
for which the receiving facility has identified a significant hazard
when the hazard is controlled before receipt of the raw material or
ingredient, a receiving facility would not be required to establish and
implement a supplier program for raw materials and ingredients for
which there are no significant hazards, for which the preventive
controls at the receiving facility are adequate to significantly
minimize or prevent each of the significant hazards, or for which the
receiving facility relies on its customer to control the hazard and
annually obtains from its customer written assurance that the customer
has established and is following procedures (identified in the written
assurance) that will significantly minimize or prevent the hazard. The
potential procedures for the supplier program would need to be written
should this provision be included in a final rule. FDA estimates that
all facilities would need to develop a written supplier program. In
Table 9, to obtain the total number of records, 4325 recordkeepers
(keeping written records of written assurances) multiplied by 0.33
records per facility per year (during the three year PRA approval)
equals 1,428 records annually. Then 1,428 multiplied by 5.33 hours to
create each record (time needed according to FDA SMEs) equals 7,611
total hours annually.
Should the potential supplier program be finalized, suppliers that
would be qualified facilities and suppliers that are farms not subject
to the requirements in proposed 21 CFR part 112 regarding the raw
material or ingredient that the receiving facility receives from the
farm would need to create at least every 2 years a written assurance to
be given to their receiving facility customers. This assurance would
need to describe the processes and procedures that the supplier is
following to ensure the safety of the animal food. FDA estimates that
these few suppliers would require about two hours to create this
documentation to be submitted to their receiving facility customers. To
obtain the total number of records, 134 recordkeepers multiplied by 0.5
records per year (submitted every 2 years) equals 67 records annually.
To obtain the total number of hours, 67 records multiplied by 2 hours
per record equals 134 hours annually.
For proposed Sec. 507.33(b)(2)(iii), FDA estimated an average of 3
hours additional time for the hazard analysis in order to account for
the possibility of economically motivated adulteration. To obtain the
total number of records, 4,325 recordkeepers multiplied by 1 record per
facility (or 0.33 records annually for the 3-year PRA approval) for
writing and developing the initial hazard analysis equals 1,428 total
records annually. Then 1,428 multiplied by an additional 3 hours per
hazard analysis equals 4,284 total hours annually. In the 2013 PRIA
(Ref. 22), FDA estimated that on average, facilities will need to
update their hazard analysis every two years. In addition, FDA
estimates 0.1 hours additional time would be needed to update the
hazard analysis. To obtain the total number of records, 4,325
recordkeepers multiplied by 0.5 records per year equals 2,163 total
records. Then 2,163 total records multiplied by 0.1 hours per record
equals 216 hours annually.
The potential supplier program would require verification of
implementation and effectiveness, including review of records for
product testing, environmental monitoring, and supplier verification
activities. Based on the responses to the ERG survey of human food
production facilities, FDA estimates that the percentage of animal food
facilities without these verification records varies from about 39% of
those with fewer than 20 employees, to less than one percent for those
with 100 or more employees. This equates to about 952 facilities, all
of which would be out of compliance with the record review verification
requirements.
To obtain the total number of records, 952 multiplied by 12 records
per year (or 1 record per month) equals 11,424 records. To obtain the
total number of hours, 11,424 records multiplied by 0.5 hours per
record (time needed according to FDA SMEs) equals 5,712 hours annually.
Reporting Burden
There is no reporting burden in this information collection.
Third Party Disclosure Burden
Under proposed Sec. 507.27(a)(3), labeling identifying the product
by the common or usual name would need to be affixed to or accompany
the animal food. The number of disclosures per respondent and the
average burden per disclosure in Table 10 below were obtained by
consulting FDA SMEs.
FDA estimates the burden for this information collection as
follows:
Table 10--Estimated Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part 507, subpart B Number of disclosures per Total annual per disclosure Total hours
respondents respondent disclosures (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 507.27 Holding and distribution............................. 8130 20 162,600 0.25 40,650
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
There are 8,130 facilities which each would have 20 sets of
labeling per facility to affix to or accompany the animal food for a
total number of 162,600 disclosures (labeling) per year. To obtain
total number of hours, 162,600 disclosures multiplied by 0.25 hour to
print labeling, and affix to the containers if labels, equals 40,650
total hours annually.
Under proposed Sec. 507.28(a)(3), labeling identifying the human
food by-product by the common or usual name would need to be affixed to
or accompany the animal food. The number of disclosures per respondent
and the average burden per disclosure in Table 11 were obtained from
FDA SMEs.
FDA estimates the burden for this information collection as
follows:
[[Page 58508]]
Table 11--Estimated Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR part 507, subpart B Number of disclosures per Total annual per disclosure Total hours
respondents respondent disclosures (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec. 507.28(a)(3) Holding and distribution of human food by- 40,798 2 81,596 0.25 20,399
products for use as animal food...................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this information collection.
According to FDA SMEs, an estimated 60 percent of the 67,996
domestic human food manufacturing facilities (Ref. 23) or 40,798
facilities would be affected, with two sets of labeling per facility
per year expected, equals 81,596 disclosures (labeling). To obtain the
number of total hours, 81,596 disclosures multiplied by 0.25 hours to
prepare labeling, and affix to the containers if labels, equals 20,399
total hours.
To ensure that comments on information collection are received, OMB
recommends that written comments be faxed to the Office of Information
and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974,
or emailed to [email protected]. All comments should
be identified with the title, ``Current Good Manufacturing Practice and
Hazard Analysis and Risk-Based Preventive Controls for Food for
Animals.''
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3407(d)), the Agency has submitted the information collection
provisions of this supplemental notice of proposed rulemaking to OMB
for review. These requirements will not be effective until FDA obtains
OMB approval. FDA will publish a notice concerning OMB approval of
these requirements in the Federal Register.
XX. Analysis of Environmental Impact
As with the 2013 preventive controls proposed rule, we determined
under 21 CFR 25.30(j) that this supplemental notice of proposed
rulemaking is an action of a type that does not individually or
cumulatively have a significant effect on the human environment (Ref.
24). Therefore, neither an environmental assessment nor an
environmental impact statement is required.
XXI. Comments
Interested persons may submit either electronic comments regarding
this document 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.
XXII. 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,
and are available electronically at http://www.regulations.gov. (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, ``FSMA Supplemental Notice of Proposed Rulemaking for
Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals. Preliminary
Regulatory Impact Analysis,'' 2014.
2. FDA, ``Transcript: FSMA Proposed Rule on Preventive Controls for
Animal Food (PCAF) Facilities Public Meeting, November 21, 2013.''
Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm368989.htm and in Docket No. FDA-2011-N-0922 (accessed on
September 5, 2014).
3. FDA, ``Transcript: FSMA Proposed Rule on Preventive Controls for
Animal Food (PCAF) Facilities Public Meeting, November 25, 2013.''
Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm368988.htm and in Docket No. FDA-2011-N-0922 (accessed on
September 5, 2014).
4. FDA, ``Transcript: FSMA Proposed Rule on Preventive Controls for
Animal Food (PCAF) Facilities Public Meeting, December 6, 2013.''
Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm371844.htm and in Docket No. FDA-2011-N-0922 (accessed on
September 5, 2014).
5. FDA, ``Update on Proposed Rules under the FDA Food Safety
Modernization Act (March 19, 2014).'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm389696.htm and in Docket
No. FDA-2011-N-0922 (accessed on September 5, 2014).
6. Cooperative Extension Service, Division of Agricultural Sciences
and Natural Resources, Oklahoma State University; USDA, Federal
Grain Inspection Service; USDA, Extension Service; USDA, Animal and
Plant Health Inspection Service, ``Stored Product Management,''
Circular No. E-912, January 1995. Available at http://entomology.k-state.edu/doc/extension-crop-pests/E912_All_Stored_Product_May3.pdf
(accessed on September 5, 2014).
7. FDA, ``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.
8. Grasser, L.A., J.G. Fadel, I. Garnett, and E.J. DePeters,
``Quantity and Economic Importance of Nine Selected By-Products Used
in California Dairy Rations,'' Journal of Dairy Science, 78:962-971,
1995.
9. FDA, ``Compliance Program 7371.003, Feed Contaminants'' December
13, 2005.
10. FDA Memorandum, ``Biological, Chemical, and Physical Hazards
Associated With Human Food By-Products Used for Animal Food,'' 2014.
11. FDA, ``Compliance Policy Guide Sec. 675.100 Diversion of
Contaminated Food for Animal Use'' Available at http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074693.htm. Revised: March 1995, Page Last Updated: December 15,
2009 (accessed on September 5, 2014).
12. FDA, ``Compliance Policy Guide Sec. 675.200 Diversion of
Adulterated Food to Acceptable Animal Feed Use'' Available at http://www.fda.gov/iceci/compliancemanuals/compliancepolicyguidancemanual/ucm074694.htm. Revised: March 1995, Page Last Updated: December 15,
2009 (accessed on September 5, 2014).
13. Association of American Feed Control Officials (AAFCO), ``Model
Good Manufacturing Practice Regulations for Feed and Feed
Ingredients'', In: AAFCO Official Publication, 210-215, 2010.
14. Food and Agriculture Organization of the United Nations (FAO)
and World Health Organization (WHO), ``Good Practices for the Feed
Industry--Implementing the Codex Alimentarius Code of Practice on
Good Animal Feeding--Section 3 Good Production Practices,'' 2010.
15. British Standards Institute (BSI), ``Publicly Available
Specification (PAS) 222:2011 Prerequisite Programmes for Food Safety
in the Manufacture of Food and Feed for Animals,'' 2011
16. FDA, ``Compliance Policy Guide Sec. 665.100 Common or Usual
Names for Animal Feed Ingredients'' Available at
[[Page 58509]]
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074687.htm. Revised: March 1995,
Page Last Updated: December 16, 2009 (accessed on September 5,
2014).
17. Codex Alimentarius Commission, ``Hazard Analysis And Critical
Control Point (HACCP) System And Guidelines For Its Application.
Annex to CAC/RCP 1-1969 (Rev. 4-2003),'' 2003.
18. Codex Alimentarius Commission, ``General Principles of Food
Hygiene, CAC/RCP 1-1969 (Rev. 4-2003),'' 2003.
19. U.S.Pharmacopeial Convention, ``U.S. Pharmacopeial Convention
(USP) Food Fraud Database,'' March 6, 2014. Available at http://www.usp.org/food-ingredients/food-fraud-database (accessed on
September 5, 2014).
20. Congressional Research Service, ``Food Fraud and Economically
Motivated Adulteration of Food and Food Ingredients,'' January 10,
2014. Available at http://www.fas.org/sgp/crs/misc/R43358.pdf.
(accessed on September 5, 2014).
21. Muth, M. K., C. Zhen, M. Coglaiti, S. Karns, and C. Viator,
``Food Processing Sector Study, Contract HHSF 22320101745G, Task
Order 13, Final Report,'' 2011.
22. FDA, ``Current Good Manufacturing Practice and Hazard Analysis
and Risk-based Preventive Controls for Food for Animals--Preliminary
Regulatory Impact Analysis,'' 2013.
23. FDA, ``Current Good Manufacturing Practice and Hazard Analysis
and Risk-based Preventive Controls for Human Food--Preliminary
Regulatory Impact Analysis,'' 2013. Docket No. FDA-2011-N-0920.
24. FDA, ``Re-proposal of Select Provisions of the Proposed Rule:
Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Food for Animals,'' 2014.
List of Subjects
21 CFR Part 16
Administrative practice and procedure.
21 CFR Part 117
Food packaging, Foods.
21 CFR Part 507
Animal foods, Labeling, Packaging and containers, Reporting and
recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR chapter I be amended as follows:
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
1. The authority citation for 21 CFR part 16 continues to read as
follows:
Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394,
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
0
2. In Sec. 16.1 amend the entry in paragraph (b)(2), as proposed to be
amended on October 29, 2013 (78 FR 64736), to read as follows:
Sec. 16.1 Scope.
* * * * *
(b) * * *
(2) * * *
Sec. Sec. 507.60 through 507.85 (part 507, subpart D) relating to
withdrawal of exemption applicable to a qualified facility.
* * * * *
PART 117--CURRENT GOOD MANUFACTURING PRACTICE AND HAZARD ANALYSIS
AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
0
3. The authority citation for 21 CFR part 117, as proposed to be added
on January 16, 2013 (78 FR 3646), continues to read as follows:
Authority: 21 U.S.C. 331, 342, 343, 350d note, 350g, 350g note,
371, 374; 42 U.S.C. 243, 264, 271.
0
4. In part 117, as proposed to be added on January 16, 2013 (78 FR
3646), add Sec. 117.95 to read as follows:
Sec. 117.95 Holding and distribution of human food by-products for
use in animal food.
(a) Human food by-products held for distribution as animal food
without additional manufacturing/processing by the human food
processor, as identified in Sec. 507.12 of this chapter, must be held
under conditions that will protect against contamination, including the
following:
(1) Containers used to hold animal food before distribution must be
designed, constructed of appropriate material, cleaned, and maintained
to prevent the contamination of animal food;
(2) Animal food held for distribution must be held in a way to
prevent contamination from sources such as trash and garbage; and
(3) Labeling identifying the by-product by the common and usual
name must be affixed to or accompany animal food.
(b) Shipping containers (for example, totes, drums, and tubs) and
bulk vehicles used to distribute animal food must be inspected prior to
use to ensure the container or vehicle will not contaminate the animal
food.
PART 507--CURRENT GOOD MANUFACTURING PRACTICE AND HAZARD ANALYSIS
AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS
0
5. The authority citation for part 507, as proposed to be added on
October 29, 2013 (78 FR 64736), continues to read as follows:
Authority: 21 U.S.C. 321, 331, 342, 350c, 350d note, 350g, 350g
note, 371, 374; 42 U.S.C. 243, 264, 271.
Subpart A--General Provisions
0
6. Amend Sec. 507.1, as proposed to be added on October 29, 2013 (78
FR 64736), by removing paragraph (d).
0
7. Amend Sec. 507.3, as proposed to be added on October 29, 2013 (78
FR 64736), as follows:
0
a. By removing definitions for ``Hazard reasonably likely to occur''
and ``Reasonably foreseeable hazard'';
0
b. By alphabetically adding new definitions for ``Known or reasonably
foreseeable hazard''; ``Pathogen''; ``Qualified auditor''; ``Receiving
facility''; ``Significant hazard''; ``Supplier''; and ``You''; and
0
c. By revising the definitions for ``Environmental pathogen'';
``Harvesting''; ``Hazard;'' ``Holding''; ``Packing''; and ``Very small
business''.
The additions and revisions read as follows:
Sec. 507.3 Definitions.
* * * * *
Environmental pathogen means a pathogen capable of surviving and
persisting within the manufacturing, processing, packing, or holding
environment such that food for animals may be contaminated and may
result in foodborne illness if that animal food is not treated to
significantly minimize or prevent the environmental pathogen.
Environmental pathogen does not include the spores of pathogenic
sporeformers.
* * * * *
Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities on a
farm. Harvesting does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and
[[Page 58510]]
Cosmetic Act. Gathering, field coring, washing, trimming of outer
leaves of, removing stems and husks from, sifting, filtering,
threshing, shelling, and cooling raw agricultural commodities grown on
a farm are examples of harvesting.
Hazard means any biological, chemical (including radiological), or
physical agent that is reasonably likely to cause illness or injury in
humans or animals in the absence of its control.
Holding means storage of food and also includes activities
performed incidental to storage of a food (e.g., activities performed
for the safe or effective storage of that food and activities performed
as a practical necessity for the distribution of that food (such as
blending of the same raw agricultural commodity and breaking down
pallets)), but does not include activities that transform a raw
agricultural commodity, as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act, into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act. Holding
facilities could include warehouses, cold storage facilities, storage
silos, grain elevators, and liquid storage tanks.
Known or reasonably foreseeable hazard means a biological, chemical
(including radiological), or physical hazard that has the potential to
be associated with the facility or the food.
* * * * *
Packing means placing food into a container other than packaging
the food and also includes activities performed incidental to packing a
food (e.g., activities performed for the safe or effective packing of
that food (such as sorting, culling and grading)), but does not include
activities that transform a raw agricultural commodity, as defined in
section 201(r) of the Federal Food, Drug, and Cosmetic Act, into a
processed food as defined in section 201(gg).
Pathogen means a microorganism of public (human or animal) health
significance.
* * * * *
Qualified auditor means a person who is a qualified individual as
defined in this part and has technical expertise obtained by a
combination of training and experience appropriate to perform the
auditing function as required by Sec. 507.53(c)(2).
* * * * *
Receiving facility means a facility that is subject to subpart C of
this part and that manufactures/processes a raw material or ingredient
that it receives from a supplier.
* * * * *
Significant hazard means a known or reasonably foreseeable hazard
for which a person knowledgeable about the safe manufacturing/
processing, packing, or holding of animal food would, based on the
outcome of a hazard analysis, establish controls to significantly
minimize or prevent the hazard in an animal food and components to
manage those controls (such as monitoring, corrections or corrective
actions, verification, and records) as appropriate to the food, the
facility, and the control.
* * * * *
Supplier means the establishment that manufactures/processes the
food, raises the animal, or harvests the food that is provided to a
receiving facility without further manufacturing/processing by another
establishment, except for further manufacturing/processing that
consists solely of the addition of labeling or similar activity of a de
minimis nature.
* * * * *
Very small business means, for purposes of this part, a business
that has less than $2,500,000 in total annual sales of food for
animals, adjusted for inflation.
You means, for purposes of this part, the owner, operator, or agent
in charge of a facility.
0
8. Amend Sec. 507.5, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraph (a) to read as follows:
Sec. 507.5 Exemptions.
(a)(1) Except as provided by paragraph (a)(2) of this section, this
part does not apply to establishments (including ``farms'' as defined
in Sec. 1.227 of this chapter) that are not required to register under
section 415 of the Federal Food, Drug, and Cosmetic Act.
(2) If a ``farm'' or ``farm mixed-type facility'' dries/dehydrates
raw agricultural commodities to create a distinct commodity, subpart B
of this part applies to the packaging, packing, and holding of the
dried commodities. Compliance with this requirement may be achieved by
complying with subpart B of this part or with the applicable
requirements for packing and holding in part 112 of this chapter.
* * * * *
0
9. Subpart A, as proposed to be added on October 29, 2013 (78 FR
64736), is amended by adding Sec. 507.12 to read as follows:
Sec. 507.12 Applicability of this part to the holding and
distribution of human food by-products for use in animal food.
(a) Except as provided by paragraph (b) of this section, the
requirements of this part do not apply to by-products of human food
production that are packed or held by that human food facility for
distribution as animal food if:
(1) The human food processor is subject to and in compliance with
subpart B of part 117 of this chapter, and in compliance with all
applicable human food safety requirements of the Federal Food, Drug,
and Cosmetic Act and implementing regulations; and
(2) The human food processor does not further manufacture/process
the by-products intended for animal food.
(b) The animal food from by-products identified in paragraph (a) of
this section must be held and distributed by that facility in
accordance with Sec. 507.28 and Sec. 117.95 of this chapter.
0
10. Revise subpart B, as proposed to be added on October 29, 2013 (78
FR 64736), to read as follows:
Subpart B--Current Good Manufacturing Practice
Sec.
507.14 Personnel.
507.17 Plant and grounds.
507.19 Sanitation.
507.20 Water supply and plumbing.
507.22 Equipment and utensils.
507.25 Plant operations.
507.27 Holding and distribution.
507.28 Holding and distribution of human food by-products for use in
animal food.
Subpart B--Current Good Manufacturing Practice
Sec. 507.14 Personnel.
(a) Plant management must take all reasonable measures and
precautions to ensure that all persons working in direct contact with
animal food, animal food-contact surfaces, and animal food-packaging
materials conform to hygienic practices to the extent necessary to
protect against contamination of animal food. The methods for
maintaining cleanliness include:
(1) Maintaining adequate personal cleanliness;
(2) Washing hands thoroughly in an adequate hand-washing facility
as necessary and appropriate to prevent contamination;
(3) Removing or securing jewelry and other objects that might fall
into animal food, equipment, or containers;
(4) Storing clothing or other personal belongings in areas other
than where animal food is exposed or where equipment or utensils are
cleaned; and
(5) Taking any other necessary precautions to protect against
contamination of animal food, animal
[[Page 58511]]
food-contact surfaces, or animal food-packaging materials.
(b) Personnel responsible for identifying sanitation failures or
animal food contamination should have a background of education or
experience, or a combination thereof, to provide a level of competency
necessary for production of clean and safe animal food. Animal food
handlers and supervisors should receive appropriate training in proper
food handling techniques and food-protection principles and should be
informed of the danger of poor personal hygiene and insanitary
practices.
(c) Responsibility for ensuring compliance by all personnel with
all requirements of this subpart must be clearly assigned to competent
supervisory personnel.
Sec. 507.17 Plant and grounds.
(a) The grounds surrounding an animal food plant under the control
of the operator must be kept in a condition that will protect against
the contamination of animal food. Maintenance of grounds must include:
(1) Properly storing equipment, removing litter and waste, and
cutting weeds or grass within the immediate vicinity of the plant that
may constitute an attractant, breeding place, or harborage for pests;
(2) Maintaining driveways, yards, and parking areas so that they do
not constitute a source of contamination in areas where animal food is
exposed;
(3) Adequately draining areas that may contribute to contamination
of animal food; and
(4) Treating and disposing of waste so that it does not constitute
a source of contamination in areas where animal food is exposed.
(b) Buildings, structures, fixtures, and other physical facilities
of the plant must be suitable in size, construction, and design to
facilitate cleaning, maintenance, and pest control to reduce the
potential for contamination of animal food, animal food-contact
surfaces, and animal food-packaging materials. This includes:
(1) Providing adequate space between equipment, walls, and stored
materials to permit employees to perform their duties and to allow
cleaning and maintenance of equipment;
(2) Being constructed in a manner such that drip or condensate from
fixtures, ducts, and pipes does not serve as a source of contamination;
(3) Providing adequate ventilation or control equipment to minimize
vapors (for example, steam) and fumes in areas where they may
contaminate animal food; and locating and operating fans and other air-
blowing equipment in a manner that minimizes the potential for
contaminating animal food;
(4) Providing adequate lighting in hand-washing areas, toilet
rooms, areas where animal food is received, manufactured/processed,
packed, or stored, and areas where equipment or utensils are cleaned;
(5) Providing safety-type light bulbs, fixtures, and skylights, or
other glass items suspended over exposed animal food in any step of
preparation, to protect against animal food contamination in case of
glass breakage; and
(6) Protecting animal food stored outdoors in bulk by any effective
means, including:
(i) Using protective coverings;
(ii) Controlling areas over and around the bulk animal food to
eliminate harborages for pests; and
(iii) Checking on a regular basis for pests and pest infestation.
Sec. 507.19 Sanitation.
(a) Buildings, structures, fixtures, and other physical facilities
of the plant must be kept clean and in good repair to prevent animal
food from becoming contaminated.
(b) Animal food-contact and non-contact surfaces of utensils and
equipment must be cleaned and maintained and utensils and equipment
stored as necessary and appropriate to protect against contamination of
animal food, animal food-contact surfaces, or animal food-packaging
materials. When necessary, equipment must be disassembled for thorough
cleaning.
In addition:
(1) When it is necessary to wet-clean animal food-contact surfaces
used for manufacturing/processing, or holding low-moisture animal food,
the surfaces must be thoroughly dried before subsequent use.
(2) In wet processing, when cleaning and sanitizing is necessary to
protect against the introduction of undesirable microorganisms into
animal food, all animal food-contact surfaces must be cleaned and
sanitized before use and after any interruption during which the animal
food-contact surfaces may have become contaminated.
(c) Cleaning compounds and sanitizing agents must be safe and
adequate under the conditions of use.
(d) The following applies to toxic materials:
(1) Only the following toxic materials may be used or stored in a
plant where animal food is manufactured/processed or exposed:
(i) Those required to maintain clean and sanitary conditions;
(ii) Those necessary for use in the plant's operations;
(iii) Those necessary for plant and equipment maintenance and
operation; and
(iv) Those necessary for use in laboratory testing procedures.
(2) Toxic materials described in paragraph (d)(1) of this section
(for example cleaning compounds, sanitizing agents, and pesticide
chemicals) must be identified, used, and stored in a manner that
protects against contamination of animal food, animal food-contact
surfaces, or animal food-packaging materials.
(e) Effective measures must be taken to exclude pests from the
manufacturing/processing, packing, and holding areas and to protect
against the contamination of animal food by pests. The use of
insecticides or rodenticides is permitted only under precautions and
restrictions that will protect against the contamination of animal
food, animal food-contact surfaces, and animal food-packaging
materials.
(f) Trash and garbage must be conveyed, stored, and disposed of in
a way that protects against contamination of animal food, animal food-
contact surfaces, animal food-packaging materials, water supplies, and
ground surfaces, and minimizes the potential for the trash and garbage
to become an attractant and harborage or breeding place for pests.
Sec. 507.20 Water supply and plumbing.
(a) The water supply must be adequate for the operations and must
be derived from a suitable source. Running water at a suitable
temperature, and under suitable pressure as needed, must be provided in
all areas where required for the manufacturing/processing of animal
food, for the cleaning of equipment, utensils, and animal food-
packaging materials, or for employee hand-washing facilities. Water
that contacts animal food, animal food-contact surfaces, or animal
food-packaging materials must be safe for its intended use. Water may
be reused for washing, rinsing, or conveying animal food if it does not
increase the level of contamination of the animal food.
(b) Plumbing must be designed, installed, and maintained to:
(1) Carry adequate quantities of water to required locations
throughout the plant;
(2) Properly convey sewage and liquid disposable waste from the
plant;
(3) Avoid being a source of contamination to animal food, animal
food-contact surfaces, or animal food-packaging materials, water
supplies,
[[Page 58512]]
equipment, or utensils, and avoid creating an unsanitary condition;
(4) Provide adequate floor drainage in all areas where floors are
subject to flooding-type cleaning or where normal operations release or
discharge water or other liquid waste on the floor; and
(5) Ensure that there is no backflow from, or cross-connection
between, piping systems that discharge waste water or sewage and piping
systems that carry water for animal food or animal food manufacturing/
processing.
(c) Sewage must be disposed of through an adequate sewerage system
or through other adequate means.
(d) Each plant must provide its employees with adequate, readily
accessible toilet facilities. Toilet facilities must be kept clean and
must not be a potential source of contamination of animal food, animal
food-contact surfaces, or animal food-packaging materials.
(e) Each plant must provide hand-washing facilities designed to
ensure that an employee's hands are not a source of contamination of
animal food, animal food-contact surfaces, or animal food-packaging
materials.
Sec. 507.22 Equipment and utensils.
(a) The following apply to plant equipment and utensils:
(1) All plant equipment and utensils must be designed and of such
material and workmanship to be adequately cleanable, and must be
properly maintained;
(2) The design, construction, and use of equipment and utensils
must preclude the contamination of animal food with lubricants, fuel,
metal fragments, contaminated water, or any other contaminants;
(3) Equipment should be installed and maintained in such a way as
to facilitate the cleaning of the equipment and adjacent spaces;
(4) Animal food-contact surfaces must be:
(i) Made of materials that withstand the environment of their use
and the action of animal food, and, if applicable, the action of
cleaning compounds and sanitizing agents;
(ii) Made of nontoxic materials; and
(iii) Maintained to protect animal food from being contaminated.
(5) Equipment in the animal food manufacturing/processing area that
does not come into contact with animal food must be designed and
constructed in such a way that it can be kept in a clean condition.
(b) Holding, conveying, and manufacturing/processing systems,
including gravimetric, pneumatic, closed, and automated systems, must
be designed, constructed, and maintained in a way that does not
contaminate animal food.
(c) Each freezer and cold storage compartment used to hold animal
food must be fitted with an accurate temperature monitoring device.
(d) Instruments and controls used for measuring, regulating, or
recording temperatures, pH, aw, or other conditions that control or
prevent the growth of undesirable microorganisms in animal food must be
accurate, precise, adequately maintained, and adequate in number for
their designated uses.
(e) Compressed air or other gases mechanically introduced into
animal food or used to clean animal food-contact surfaces or equipment
must be used in such a way that animal food is not contaminated.
Sec. 507.25 Plant operations.
(a) Plant management must ensure that:
(1) All operations in the manufacturing/processing, packing, and
holding of animal food (including operations directed to receiving,
inspecting, transporting, and segregating) are conducted in accordance
with the current good manufacturing practice requirements of this
subpart;
(2) Containers holding animal food, including raw materials,
ingredients, or rework, accurately identify the contents;
(3) The labeling for the finished animal food product contains
information and instructions for safely using the product for the
intended animal species;
(4) Animal food-packaging materials are safe and suitable;
(5) The overall cleanliness of the plant is under the supervision
of one or more competent individuals assigned responsibility for this
function;
(6) Reasonable precautions are taken so that plant operations do
not contribute to contamination of animal food, animal food-contact
surfaces, and animal food packaging materials;
(7) Chemical, microbial, or extraneous-material testing procedures
are used where necessary to identify sanitation failures or possible
animal food contamination; and
(8) Animal food that has become contaminated to the extent that it
is adulterated is rejected, disposed of, or if permissible, treated or
processed to eliminate the adulteration. If disposed of, it must be
done in a manner that protects against the contamination of other
animal food; and
(9) All animal food manufacturing/processing, packing, and holding
is conducted under such conditions and controls as are necessary to
minimize the potential for the growth of undesirable microorganisms or
for the contamination of animal food.
(b) Raw materials and ingredients:
(1) Must be inspected to ensure that they are suitable for
manufacturing/processing into animal food and must be handled under
conditions that will protect against contamination and minimize
deterioration. In addition:
(i) Shipping containers (for example, totes, drums, and tubs) and
bulk vehicles holding raw materials and ingredients must be inspected
upon receipt to determine whether contamination or deterioration of
animal food has occurred;
(ii) Raw materials must be cleaned as necessary to minimize soil or
other contamination; and
(iii) Raw materials and ingredients must be stored under conditions
that will protect against contamination and deterioration.
(2) Susceptible to contamination with mycotoxins or other natural
toxins must be evaluated and used in a manner that does not result in
animal food that can cause injury or illness to animals or humans;
(3) And all rework, must be held in containers designed and
constructed in a way that protects against contamination, and must be
held under conditions, e.g., appropriate temperature and relative
humidity, that will minimize the potential for growth of undesirable
microorganisms and in a manner that prevents the animal food from
becoming adulterated; and
(4) If frozen, must be kept frozen. If thawing is required prior to
use, it must be done in a manner that minimizes the potential for the
growth of undesirable microorganisms.
(c) For the purposes of manufacturing/processing operations, the
following apply:
(1) Animal food must be maintained under conditions, e.g.,
appropriate temperature and relative humidity, that will minimize the
potential for growth of undesirable microorganisms and prevent the
animal food from becoming adulterated during manufacturing/processing,
packing, and holding;
(2) Measures taken during manufacturing/processing, packing, and
holding of animal food to significantly minimize or prevent the growth
of undesirable microorganisms (for example, heat treating, freezing,
refrigerating, irradiating, controlling pH, or controlling aw) must be
adequate to prevent adulteration of animal food;
(3) Work-in-process and rework must be handled in such a way that
it is
[[Page 58513]]
protected against contamination and the growth of undesirable
microorganisms;
(4) Steps such as cutting, drying, defatting, grinding, mixing,
extruding, pelleting, and cooling, must be performed in a way that
protects animal food against contamination;
(5) Filling, assembling, packaging, and other operations must be
performed in such a way that the animal food is protected against
contamination and growth of undesirable microorganisms;
(6) Animal food that relies on the control of aw for preventing the
growth of undesirable microorganisms must be processed to and
maintained at a safe moisture level;
(7) Animal food that relies principally on the control of pH for
preventing the growth of undesirable microorganisms must be monitored
and maintained at the appropriate pH; and
(8) When ice is used in contact with animal food, it must be made
from water that is safe and must be used only if it has been
manufactured in accordance with current good manufacturing practice as
outlined in this subpart.
Sec. 507.27 Holding and distribution.
(a) Animal food held for distribution must be held under conditions
that will protect against contamination and minimize deterioration,
including the following:
(1) Containers used to hold animal food before distribution must be
designed, constructed of appropriate material, cleaned, and maintained
to prevent the contamination of animal food;
(2) Animal food held for distribution must be held in a way that
prevents contamination from sources such as trash and garbage; and
(3) Labeling identifying the product by the common and usual name
must be affixed to or accompany the animal food.
(b) Shipping containers (for example, totes, drums, and tubs) and
bulk vehicles used to distribute animal food must be inspected prior to
use to ensure the container or vehicle will not contaminate the animal
food.
(c) Animal food returned from distribution must be assessed for
animal food safety to determine the appropriate disposition. Returned
animal food must be identified as such and segregated until assessed.
(d) Unpackaged or bulk animal food must be held in a manner that
does not result in cross contamination with other animal food.
Sec. 507.28 Holding and distribution of human food by-products for
use as animal food.
(a) Human food by-products held for distribution as animal food
must be held under conditions that will protect against contamination,
including the following:
(1) Containers used to hold animal food before distribution must be
designed, constructed of appropriate material, cleaned, and maintained
to prevent the contamination of animal food;
(2) Animal food held for distribution must be held in a way to
prevent contamination from sources such as trash and garbage; and
(3) Labeling identifying the product by the common and usual name
must be affixed to or accompany animal food.
(b) Shipping containers (for example, totes, drums, and tubs) and
bulk vehicles used to distribute animal food must be inspected prior to
use to ensure the container or vehicle will not contaminate the animal
food.
0
11. Revise subpart C, as proposed to be added on October 29, 2013 (78
FR 64736), to read as follows:
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
Sec.
507.31 Food safety plan.
507.33 Hazard analysis.
507.36 Preventive controls.
507.37 Supplier program.
507.38 Recall plan.
507.39 Preventive control management components.
507.40 Monitoring.
507.42 Corrective actions and corrections.
507.45 Verification.
507.47 Validation.
507.49 Verification of implementation and effectiveness.
507.50 Reanalysis.
507.51 Modified requirements that apply to a facility solely engaged
in the storage of packaged animal food that is not exposed to the
environment.
507.53 Requirements applicable to a qualified individual and a
qualified auditor.
507.55 Implementation records.
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
Sec. 507.31 Food safety plan.
(a) You must prepare, or have prepared, and implement a written
food safety plan.
(b) One or more qualified individuals must prepare, or oversee the
preparation of, the food safety plan.
(c) The written food safety plan must include:
(1) The written hazard analysis as required by Sec. 507.33(a)(2);
(2) The written preventive controls as required by Sec. 507.36(b);
(3) The written supplier program as required by Sec. 507.37(a)(2).
(4) The written recall plan as required by Sec. 507.38(a)(1);
(5) The written procedures for monitoring the implementation of the
preventive controls as required by Sec. 507.40(a)(1);
(6) The written corrective action procedures as required by Sec.
507.42(a)(1); and
(7) The written verification procedures as required by Sec.
507.49(b).
(d) The food safety plan required by this section is a record that
is subject to the requirements of subpart F of this part.
Sec. 507.33 Hazard analysis.
(a) You must:
(1) Identify and evaluate, based on experience, illness data,
scientific reports, and other information, known or reasonably
foreseeable hazards for each type of animal food manufactured/
processed, packed, or held at your facility to determine whether there
are significant hazards; and
(2) Develop a written hazard analysis.
(b) The hazard identification must consider:
(1) Hazards that include:
(i) Biological hazards, including microbiological hazards such as
parasites, environmental pathogens, and other pathogens;
(ii) Chemical hazards, including radiological hazards, substances
such as pesticide and drug residues, natural toxins, decomposition,
unapproved food or color additives, and nutrient imbalances; and
(iii) Physical hazards; and
(2) Hazards that may be present in the animal food for any of the
following reasons:
(i) The hazard occurs naturally;
(ii) The hazard may be unintentionally introduced; or
(iii) The hazard may be intentionally introduced for purposes of
economic gain.
(c)(1) The hazard analysis must include an evaluation of the
hazards identified in paragraph (b) of this section to assess the
severity of the illness or injury if the hazard were to occur and the
probability that the hazard will occur in the absence of preventive
controls.
(2) The hazard evaluation required by paragraph (c)(1) of this
section must include an evaluation of environmental pathogens whenever
an animal food is exposed to the environment prior to packaging and the
packaged animal food does not receive a treatment that would
significantly minimize the pathogen.
(d) The hazard evaluation must consider the effect of the following
on
[[Page 58514]]
the safety of the finished animal food for the intended animal:
(1) The formulation of the animal food;
(2) The condition, function, and design of the facility and
equipment;
(3) Raw materials and ingredients;
(4) Transportation practices;
(5) Manufacturing/processing procedures;
(6) Packaging activities and labeling activities;
(7) Storage and distribution;
(8) Intended or reasonably foreseeable use;
(9) Sanitation, including employee hygiene; and
(10) Any other relevant factors.
Sec. 507.36 Preventive controls.
(a)(1) You must identify and implement preventive controls to
provide assurances that significant hazards will be significantly
minimized or prevented and the animal food manufactured, processed,
packed, or held by your facility will not be adulterated under section
402 of the Federal Food, Drug, and Cosmetic Act; and
(2) Preventive controls required by paragraph (a)(1) of this
section include, as appropriate to the facility and animal food:
(i) Controls at critical control points (CCPs), if there are any
CCPs; and
(ii) Controls, other than those at CCPs, that are also appropriate
for animal food safety.
(b) Preventive controls must be written.
(c) Preventive controls include, as appropriate to the facility and
animal food:
(1) Process controls include procedures, practices, and processes
to ensure the control of parameters during operations such as heat
processing, irradiating, and refrigerating animal food. Process
controls must include, as appropriate to the applicable control:
(i) Parameters associated with the control of the hazard; and
(ii) The maximum or minimum value, or combination of values, to
which any biological, chemical, or physical parameter must be
controlled to significantly minimize or prevent a significant hazard.
(2) Sanitation controls include procedures, practices, and
processes to ensure that the facility is maintained in a sanitary
condition adequate to significantly minimize or prevent hazards such as
environmental pathogens and biological hazards due to employee
handling. Sanitation controls must include as appropriate to the
facility and the animal food, procedures, practices, and processes for
the:
(i) Cleanliness of animal food-contact surfaces, including animal
food-contact surfaces of utensils and equipment; and
(ii) Prevention of cross-contamination from insanitary objects and
from personnel to animal food, animal food packaging material, and
other animal food-contact surfaces and from raw product to processed
product.
(3) Supplier controls that include the supplier program as required
by Sec. 507.37;
(4) A recall plan as required by Sec. 507.38; and
(5) Other preventive controls that include any procedures,
practices, and processes necessary to satisfy the requirements of
paragraph (a) of this section. Examples of other controls include
hygiene training and other current good manufacturing practices.
Sec. 507.37 Supplier program.
(a)(1)(i) Except as provided in paragraph (a)(1)(ii) of this
section, the receiving facility must establish and implement a risk-
based supplier program for those raw materials and ingredients for
which the receiving facility has identified a significant hazard when
the hazard is controlled before receipt of the raw material or
ingredient.
(ii) The receiving facility is not required to establish and
implement a supplier program for raw materials and ingredients for
which:
(A) There are no significant hazards;
(B) The preventive controls at the receiving facility are adequate
to significantly minimize or prevent each of the significant hazards;
or
(C) The receiving facility relies on its customer to control the
hazard and annually obtains from its customer written assurance that
the customer has established and is following procedures (identified in
the written assurance) that will significantly minimize or prevent the
hazard.
(2) The supplier program must be written.
(3) The supplier program must include:
(i) Verification activities, as appropriate to the hazard, and
documentation of these activities, to ensure raw materials and
ingredients are received only from suppliers approved for control of
the hazard(s) in that raw material or ingredient (or, when necessary
and appropriate, on a temporary basis from unapproved suppliers whose
raw materials or ingredients the receiving facility subjects to
adequate verification activities before acceptance for use); and
(ii) Verification activities, as appropriate to the hazard, and
documentation of these activities, as required by paragraph (b) of this
section, to verify that:
(A) The hazard is significantly minimized or prevented;
(B) The incoming raw material or ingredient is not adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act; and
(C) The incoming raw material or ingredient is produced in
compliance with the requirements of applicable FDA food safety
regulations.
(4) When supplier verification activities are required under
paragraph (c) of this section for more than one type of hazard in an
animal food, the receiving facility must conduct the verification
activity or activities appropriate for each of those hazards.
(5) For some hazards, in some situations under paragraph (b) it
will be necessary to conduct more than one verification activity and/or
to increase the frequency of one or more verification activities to
provide adequate assurances that the hazard is significantly minimized
or prevented.
(b) In determining and documenting the appropriate verification
activities, the receiving facility must consider the following:
(1) The hazard analysis, including the nature of the hazard,
applicable to the raw material and ingredients;
(2) Where the preventive controls for those hazards are applied for
the raw material and ingredients such as at the supplier or the
supplier's supplier;
(3) The supplier's procedures, processes, and practices related to
the safety of the raw material and ingredients;
(4) Applicable FDA food safety regulations and information relevant
to the supplier's compliance with those regulations, including an FDA
warning letter or import alert relating to the safety of the animal
food;
(5) The supplier's food safety performance history relevant to the
raw materials or ingredients that the receiving facility receives from
the supplier, including available information about results from
testing raw materials or ingredients for hazards, audit results
relating to the safety of the animal food, and responsiveness of the
supplier in correcting problems; and
(6) Any other factors as appropriate and necessary. Examples of
factors that a receiving facility may determine are appropriate and
necessary are storage and transportation practices.
(c)(1) Except as provided in paragraph (c)(2) or (3) of this
section, the receiving facility must conduct and document one or more
of the following supplier verification activities determined by the
[[Page 58515]]
receiving facility under paragraph (b) of this section, for each
supplier before using the raw material or ingredient and periodically
thereafter:
(i) Onsite audits;
(ii) Sampling and testing of the raw material or ingredient, which
may be conducted by either the supplier or receiving facility;
(iii) Review by the receiving facility of the supplier's relevant
food safety records; or
(iv) Other appropriate supplier verification activities based on
the risk associated with the ingredient and the supplier.
(2)(i) Except as provided by paragraph (c)(2)(ii) of this section,
when a hazard in a raw material or ingredient will be controlled by the
supplier and is one for which there is a reasonable probability that
exposure to the hazard will result in serious adverse health
consequences or death to humans or animals, the receiving facility must
have documentation of an onsite audit of the supplier before using the
raw material or ingredient from the supplier and at least annually
thereafter.
(ii) The requirements of paragraph (c)(2)(i) of this section do not
apply if the receiving facility documents its determination that other
verification activities and/or less frequent onsite auditing of the
supplier provide adequate assurance that the hazards are controlled.
(3) If a supplier is a qualified facility as defined by Sec.
507.3, the receiving facility need not comply with paragraphs (c)(1)
and (2) of this section if the receiving facility:
(i) Documents, at the end of each calendar year, that the supplier
is a qualified facility as defined by Sec. 507.3; and
(ii) Obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or ingredient in compliance with
applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act. The written assurance must include a brief
description of the processes and procedures that the supplier is
following to ensure the safety of the animal food.
(4) If a supplier is a farm that is not subject to the requirements
established in part 112 of this chapter in accordance with Sec. 112.4
regarding the raw material or ingredient that the receiving facility
receives from the farm, the receiving facility does not need to comply
with paragraphs (c)(1) and (2) of this section if the receiving
facility:
(i) Documents, at the end of each calendar year, that the raw
material or ingredient provided by the supplier is not subject to part
112 of this chapter; and
(ii) Obtains written assurance, at least every 2 years, that the
supplier is producing the raw material or ingredient in compliance with
applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act.
(d)(1) An onsite audit of a supplier must be performed by a
qualified auditor;
(2) If the raw material or ingredient at the supplier is subject to
one or more FDA food safety regulations, an onsite audit must consider
such regulations and include a review of the supplier's written plan
(e.g., HACCP plan or other food safety plan), if any, including its
implementation, for the hazard being audited.
(e)(1) Instead of an onsite audit, a receiving facility may rely on
the results of an inspection of the supplier by FDA or, for a foreign
supplier, by FDA or the food safety authority of a country whose food
safety system FDA has recognized as comparable or has determined to be
equivalent to that of the United States, provided that the inspection
was conducted within 1 year of the date that the onsite audit would
have been required to be conducted; and
(2) For inspections conducted by the food safety authority of a
country whose food safety system FDA has officially recognized as
comparable or determined to be equivalent, the animal food that is the
subject of the onsite audit must be within the scope of the official
recognition or equivalence determination, and the foreign supplier must
be in, and under the regulatory oversight of, such country.
(f) If the owner, operator, or agent in charge of a receiving
facility determines through auditing, verification testing, relevant
consumer, customer, or other complaints, or otherwise that the supplier
is not controlling hazards that the receiving facility has identified
as significant, the receiving facility must take and document prompt
action in accordance with Sec. 507.42 to ensure that raw materials or
ingredients from the supplier do not cause animal food that is
manufactured or processed by the receiving facility to be adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act.
(g) The receiving facility must document the following in records
and review such records in accordance with Sec. 507.49(a)(4):
(1) The written supplier program;
(2) Documentation of the appropriate verification activities;
(3) The annual written assurance that a receiving facility's
customer who is controlling a significant hazard has established and is
following procedures (identified in the written assurance) that will
significantly minimize or prevent the hazard;
(4) Documentation demonstrating that products are received only
from approved suppliers;
(5) Documentation of an onsite audit. This documentation must
include:
(i) Documentation of audit procedures;
(ii) The dates the audit was conducted;
(iii) The conclusions of the audit;
(iv) Corrective actions taken in response to significant
deficiencies identified during the audit; and
(v) Documentation that the audit was conducted by a qualified
auditor.
(6) Records of sampling and testing. These records must include:
(i) Identification of the raw material or ingredient tested
(including lot number, as appropriate) and the number of samples
tested;
(ii) Identification of test(s) conducted, including the analytical
method(s) used;
(iii) The date(s) on which the test(s) were conducted;
(iv) The results of the testing;
(v) Corrective actions taken in response to detection of hazards;
and
(vi) Information identifying the laboratory conducting the testing.
(7) Records of the review by the receiving facility of the
supplier's relevant food safety records. These records must include:
(i) The date(s) of review;
(ii) Corrective actions taken in response to significant
deficiencies identified during the review; and
(iii) Documentation that the review was conducted by a qualified
individual.
(8) Records of other appropriate supplier verification activities
based on the risk associated with the ingredient.
(9) Documentation of any determination that verification activities
other than an onsite audit, and/or less frequent onsite auditing of a
supplier, provide adequate assurance that the hazards are controlled;
(10) Documentation of an alternative verification activity for a
supplier that is a qualified facility, including:
(i) The documentation that the supplier is a qualified facility as
defined by Sec. 507.3; and
(ii) The written assurance that the supplier is producing the raw
material or ingredient in compliance with
[[Page 58516]]
applicable FDA food safety regulations and that the raw material or
ingredient is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act.
(11) Documentation of an alternative verification activity for a
supplier that is a farm that supplies a raw material or ingredient that
is not subject to part 112 of this chapter, including:
(i) The documentation that the raw material or ingredient provided
by the supplier is not subject to part 112 of this chapter; and
(ii) The written assurance that the supplier is producing the raw
material or ingredient in compliance with applicable FDA food safety
regulations and that the raw material or ingredient is not adulterated
under section 402 of the Federal Food, Drug, and Cosmetic Act.
(12) Evidence of an inspection of the supplier by FDA or the food
safety authority of another country.
(13) Documentation of actions taken with respect to supplier non-
conformance.
Sec. 507.38 Recall plan.
(a) For animal food with a significant hazard you must:
(1) Establish a written recall plan for the animal food; and
(2) Assign responsibility for performing all procedures in the
recall plan.
(b) The written recall plan must include procedures that describe
the steps to perform the following actions as appropriate to the
facility:
(1) Directly notify direct consignees about the animal food being
recalled, including how to return or dispose of the affected animal
food;
(2) Notify the public about any hazard presented by the animal food
when appropriate to protect animal and human health;
(3) Conduct effectiveness checks (as described in part 7 of this
chapter) to verify the recall has been carried out; and
(4) Appropriately dispose of recalled animal food (e.g.,
reprocessing, reworking, diverting to another use that would not
present a safety concern, or destroying).
Sec. 507.39 Preventive control management components.
(a) Except as provided by paragraphs (b) and (c) of this section,
the preventive controls required under Sec. 507.36 are subject to the
following preventive control management components as appropriate to
ensure the effectiveness of the preventive controls, taking into
account the nature of the preventive control:
(1) Monitoring in accordance with Sec. 507.40;
(2) Corrective actions and corrections in accordance with Sec.
507.42; and
(3) Verification in accordance with Sec. 507.45.
(b) The supplier program established in Sec. 507.37 is subject to
the following preventive control management components as appropriate
to ensure the effectiveness of the supplier program, taking into
account the nature of the hazard controlled before receipt of the raw
material or ingredient:
(1) Corrective actions and corrections in accordance with Sec.
507.42, taking into account the nature of any supplier non-conformance;
(2) Review of records in accordance with Sec. 507.49(a)(4)(ii);
and
(3) Reanalysis in accordance with Sec. 507.50.
(c) The recall plan established in Sec. 507.38 is not subject to
the requirements of paragraph (a) of this section.
Sec. 507.40 Monitoring.
(a) As appropriate to the preventive control you must:
(1) Establish and implement written procedures, including the
frequency with which they are to be performed, for monitoring the
preventive controls; and
(2) Monitor the preventive controls with adequate frequency to
provide assurance that they are consistently performed.
(b) You must monitor the preventive controls with adequate
frequency to provide assurance that the preventive controls are
consistently performed.
(c) All monitoring of preventive controls in accordance with this
section must be documented in records that are subject to verification
in accordance with Sec. 507.45(a)(2) and records review in accordance
with Sec. 507.49(a)(4)(i).
Sec. 507.42 Corrective actions and corrections.
(a) As appropriate to the preventive control, except as provided by
paragraph (c) of this section:
(1)(i) You must establish and implement written corrective action
procedures that must be taken if preventive controls are not properly
implemented.
(ii) The corrective action procedures required by paragraph
(a)(1)(i) of this section must include procedures to address, as
appropriate:
(A) The presence of a pathogen or appropriate indicator organism in
animal food detected as a result of product testing conducted in
accordance with Sec. 507.49(a)(2); and
(B) The presence of an environmental pathogen or appropriate
indicator organism detected through the environmental monitoring
conducted in accordance with Sec. 507.49(a)(3).
(2) The corrective action procedures must describe the steps to be
taken to ensure that:
(i) Appropriate action is taken to identify and correct a problem
that has occurred with implementation of a preventive control;
(ii) Appropriate action is taken when necessary, to reduce the
likelihood that the problem will recur;
(iii) All affected animal food is evaluated for safety; and
(iv) All affected animal food is prevented from entering into
commerce if you cannot ensure the affected animal food is not
adulterated under section 402 of the Federal Food, Drug, and Cosmetic
Act.
(b)(1) Except as provided by paragraph (c) of this section, you are
subject to the requirements of paragraph (b)(2) of this section if any
of the following circumstances apply:
(i) A preventive control is not properly implemented and a specific
corrective action procedure has not been established;
(ii) A preventive control is found to be ineffective; or
(iii) A review of records in accordance with Sec. 507.49(a)(4)
finds that the records are not complete, the activities conducted did
not occur in accordance with the food safety plan, or appropriate
decisions were not made about corrective actions.
(2) If any of the circumstances listed in paragraph (b)(1) of this
section apply, you must:
(i) Take corrective action to identify and correct the problem;
(ii) Reduce the likelihood that the problem will recur;
(iii) Evaluate all affected animal food for safety;
(iv) As necessary, prevent affected animal food from entering
commerce as would be done following the corrective action procedure
under paragraph (a)(2) of this section; and
(v) When appropriate, reanalyze the food safety plan in accordance
with Sec. 507.50 to determine whether modification of the food safety
plan is required.
(c) You do not need to comply with the requirements of paragraphs
(a) and (b) of this section for conditions and practices that are not
consistent with the sanitation controls in Sec. 507.36(c)(2)(i) or
(ii) if you take action, in a timely manner, to correct such conditions
and practices.
(d) All corrective actions (and, when appropriate, corrections)
taken in accordance with this section must be
[[Page 58517]]
documented in records. These records are subject to verification in
accordance with Sec. 507.45(a)(3) and records review in accordance
with Sec. 507.49(a)(4)(i).
Sec. 507.45 Verification.
(a) Verification activities must include, as appropriate to the
preventive control:
(1) Validation in accordance with Sec. 507.47;
(2) Verification that monitoring is being conducted as required by
Sec. 507.39 (and in accordance with Sec. 507.40);
(3) Verification that appropriate decisions about corrective
actions are being made as required by Sec. 507.39 (and in accordance
with Sec. 507.42);
(4) Verification of implementation and effectiveness in accordance
with Sec. 507.49; and
(5) Reanalysis in accordance with Sec. 507.50.
(b) All verification activities conducted in accordance with this
section must be documented in records.
Sec. 507.47 Validation.
(a) Except as provided by paragraph (b)(3) of this section, you
must validate that the preventive controls identified and implemented
in accordance with Sec. 507.36 to control the significant hazards are
adequate to do so as appropriate to the nature of the preventive
control.
(b) The validation of the preventive controls:
(1) Must be performed (or overseen) by a qualified individual:
(i) Prior to implementation of the food safety plan or, when
necessary, during the first 6 weeks of production; and
(ii) Whenever a reanalysis of the food safety plan reveals the need
to do so;
(2) Must include collecting and evaluating scientific and technical
information (or, when such information is not available or is
inadequate, conducting studies) to determine whether the preventive
controls, when properly implemented, will effectively control
significant hazards; and
(3) Need not address:
(i) The sanitation controls in Sec. 507.36(c)(2);
(ii) The supplier program in Sec. 507.37; and
(iii) The recall plan in Sec. 507.38.
Sec. 507.49 Verification of implementation and effectiveness.
(a) You must verify that the preventive controls are consistently
implemented and are effectively and significantly minimizing or
preventing the significant hazards. To do so, you must conduct
activities that include the following, as appropriate to the facility,
the animal food, and the nature of the preventive control:
(1) Calibration of process monitoring and verification instruments;
(2) Product testing for a pathogen (or appropriate indicator
organism) or other hazard;
(3) Environmental monitoring, for an environmental pathogen or for
an appropriate indicator organism, if contamination of an animal food
with an environmental pathogen is a significant hazard, by collecting
and testing environmental samples; and
(4) Review of the following records within the specified
timeframes, by (or under the oversight of) a qualified individual, to
ensure the records are complete, the activities reflected in the
records occurred in accordance with the food safety plan, the
preventive controls are effective, and appropriate decisions were made
about corrective actions:
(i) Monitoring and corrective action records within a week after
the records are created; and
(ii) Records of calibration, product testing, environmental
monitoring, and supplier verification activities within a reasonable
time after the records are created.
(b) As appropriate to the facility, the food, and the nature of the
preventive control, you must establish and implement written procedures
for the following activities:
(1) The method and frequency of calibrating process monitoring
instruments and verification instruments as required by paragraph
(a)(1) of this section.
(2) Product testing as required by paragraph (a)(2) of this
section. Procedures for product testing must:
(i) Be scientifically valid;
(ii) Identify the test microorganism(s) or other analyte(s);
(iii) Specify the procedures for identifying samples, including
their relationship to specific lots of product;
(iv) Include the procedures for sampling, including the number of
samples and the sampling frequency;
(v) Identify the test(s) conducted, including the analytical
method(s) used;
(vi) Identify the laboratory conducting the testing; and
(vii) Include the corrective action procedures required by Sec.
507.42(a)(1).
(3) Environmental monitoring as required by paragraph (a)(3) of
this section. Procedures for environmental monitoring must:
(i) Be scientifically valid;
(ii) Identify the test microorganism(s);
(iii) Identify the locations from which samples will be collected
and the number of sites to be tested during routine environmental
monitoring. The number and location of sampling sites must be adequate
to determine whether preventive controls are effective;
(iv) Identify the timing and frequency for collecting and testing
samples. The timing and frequency for collecting and testing samples
must be adequate to determine whether preventive controls are
effective;
(v) Identify the test(s) conducted, including the analytical
method(s) used;
(vi) Identify the laboratory conducting the testing; and
(vii) Include the corrective action procedures required by Sec.
507.42(a)(1)(ii).
Sec. 507.50 Reanalysis.
(a) You must conduct a reanalysis of the food safety plan:
(1) At least once every 3 years;
(2) Whenever a significant change is made in the activities
conducted at your facility if the change creates a reasonable potential
for a new hazard or creates a significant increase in a previously
identified hazard;
(3) Whenever you become aware of new information about potential
hazards associated with the animal food;
(4) Whenever appropriate after an unanticipated animal food safety
problem in accordance with Sec. 507.42(b); and
(5) Whenever you find that a preventive control is ineffective.
(b) You must complete the reanalysis required by paragraph (a) of
this section and implement any additional preventive controls needed to
address the hazard identified, if any, before the change in activities
at the facility is operative or, when necessary, during the first 6
weeks of production.
(c) You must revise the written food safety plan if a significant
change is made or document the basis for the conclusion that no
revisions are needed.
(d) A qualified individual must perform (or oversee) the
reanalysis.
(e) You must conduct a reanalysis of the food safety plan when FDA
determines it is necessary to respond to new hazards and developments
in scientific understanding.
Sec. 507.51 Modified requirements that apply to a facility solely
engaged in the storage of packaged animal food that is not exposed to
the environment.
(a) The owner, operator, or agent in charge of a facility solely
engaged in the storage of packaged animal food that is not exposed to
the environment must conduct the following activities for any such
refrigerated packaged animal food that requires time/temperature
control to significantly minimize or prevent the
[[Page 58518]]
growth of, or toxin formation by, microorganisms of animal or human
health significance:
(1) Establish and implement temperature controls adequate to
significantly minimize or prevent the growth of, or toxin formation by,
microorganisms of animal or human health significance;
(2) Monitor the temperature controls with sufficient frequency to
provide assurance they are consistently performed;
(3) Take appropriate corrective actions if there is a problem with
the temperature controls for such refrigerated packaged animal food to:
(i) Correct the problem and reduce the likelihood that the problem
will recur;
(ii) Evaluate all affected animal food for safety; and
(iii) Prevent the animal food from entering commerce, if the owner,
operator, or agent in charge of the facility cannot ensure the affected
animal food is not adulterated under section 402 of the Federal Food,
Drug, and Cosmetic Act;
(4) Verify that temperature controls are consistently implemented
by:
(i) Calibrating temperature monitoring and recording devices;
(ii) Reviewing records of calibration within a reasonable time
after the records are made; and
(iii) Reviewing records of monitoring and corrective actions taken
to correct a problem with the control of temperature within a week
after the records are made;
(5) Establish and maintain the following records:
(i) Records documenting the monitoring of temperature controls for
any such refrigerated packaged animal food;
(ii) Records of corrective actions taken when there is a problem
with the control of temperature for any such refrigerated packaged
animal food; and
(iii) Records documenting the verification activities.
(b) The records that a facility must establish and maintain under
paragraph (a)(5) of this section are subject to the requirements of
subpart F of this part.
Sec. 507.53 Requirements applicable to a qualified individual and a
qualified auditor.
(a) One or more qualified individuals must do or oversee the
following:
(1) Preparation of the food safety plan (Sec. 507.31(b));
(2) Validation of the preventive controls (Sec. 507.47(b)(1));
(3) Review of records (Sec. 507.49(a)(4)); and
(4) Reanalysis of the food safety plan (Sec. 507.50(d)).
(b) A qualified auditor must conduct an onsite audit (Sec.
507.37(d)).
(c)(1) To be a qualified individual, the individual must have
successfully completed training in the development and application of
risk-based preventive controls at least equivalent to that received
under a standardized curriculum recognized as adequate by FDA or be
otherwise qualified through job experience to develop and apply a food
safety system. Job experience may qualify an individual to perform
these functions if such experience has provided an individual with
knowledge at least equivalent to that provided through the standardized
curriculum. This individual may be, but is not required to be, an
employee of the facility.
(2) To be a qualified auditor, a qualified individual must have
technical expertise obtained by a combination of training and
experience appropriate to perform the auditing function.
(d) All applicable training must be documented in records,
including the date of the training, the type of training, and the
person(s) trained.
Sec. 507.55 Implementation records.
(a) You must establish and maintain the following records
documenting implementation of the food safety plan:
(1) Records that document the monitoring of preventive controls;
(2) Records that document corrective actions;
(3) Records that document verification, including, as applicable,
those related to:
(i) Validation;
(ii) Verification of monitoring;
(iii) Verification of corrective actions;
(iv) Calibration of process monitoring and verification
instruments;
(v) Product testing;
(vi) Environmental monitoring;
(vii) Records review; and
(viii) Reanalysis;
(4) Records that document the supplier program; and
(5) Records that document applicable training for the qualified
individual and the qualified auditor.
(b) The records that you must establish and maintain are subject to
the requirements of subpart F of this part.
0
12. Section 507.60, as proposed to be added on October 29, 2013 (78 FR
64736), is revised to read as follows:
Sec. 507.60 Circumstances that may lead FDA to withdraw an exemption
applicable to a qualified facility.
(a) FDA may withdraw the exemption applicable to a qualified
facility under Sec. 507.5(d):
(1) In the event of an active investigation of a foodborne illness
outbreak that is directly linked to the qualified facility; or
(2) If FDA determines that it is necessary to protect the public
(human or animal) health and prevent or mitigate a foodborne illness
outbreak based on conditions or conduct associated with the qualified
facility that are material to the safety of the animal food
manufactured, processed, packed, or held at such facility.
(b) Before FDA issues an order to withdraw an exemption applicable
to a qualified facility, FDA:
(1) May consider one or more other actions to protect the public
(human or animal) health or mitigate a foodborne illness outbreak,
including, a warning letter, recall, administrative detention,
suspension of registration, import alert, seizure, and injunction;
(2) Must notify the owner, operator, or agent in charge of the
facility, in writing of circumstances that may lead FDA to withdraw the
exemption, and provide an opportunity for the owner, operator, or agent
in charge of the facility to respond in writing, within 10 calendar
days of the date of receipt of the notification, to FDA's notification;
and
(3) Must consider the actions taken by the facility to address the
circumstances that may lead FDA to withdraw the exemption.
0
13. Section 507.62, as proposed to be added on October 29, 2013 (78 FR
64736), is revised to read as follows:
Sec. 507.62 Issuance of an order to withdraw an exemption applicable
to a qualified facility.
(a) An FDA District Director in whose district the qualified
facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine), or an FDA official senior to such Director, must approve an
order to withdraw the exemption before the order is issued.
(b) Any officer or qualified employee of FDA may issue an order to
withdraw the exemption after it has been approved in accordance with
paragraph (a) of this section.
(c) FDA must issue an order to withdraw the exemption to the owner,
operator, or agent in charge of the facility.
(d) FDA must issue an order to withdraw the exemption in writing,
signed and dated by the officer or qualified employee of FDA who is
issuing the order.
0
14. Amend Sec. 507.65, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraph (d) to read as follows:
[[Page 58519]]
Sec. 507.65 Contents of an order to withdraw an exemption applicable
to a qualified facility.
* * * * *
(d) A statement that the facility must either:
(1) Comply with subpart C of this part on the date that is 120
calendar days after the date of receipt of the order; or
(2) Appeal the order within 10 calendar days of the date of receipt
of the order in accordance with the requirements of Sec. 507.69.
* * * * *
0
15. Amend Sec. 507.67, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraphs (a) and (c) to read as follows
Sec. 507.67 Compliance with, or appeal of, an order to withdraw an
exemption applicable to a qualified facility.
(a) If you receive an order under Sec. 507.65 to withdraw an
exemption applicable to that facility under Sec. 507.5(d), you must
either:
(1) Comply with applicable requirements of this part within 120
calendar days of the date of receipt of the order; or
(2) Appeal the order within 10 calendar days of the date of receipt
of the order in accordance with the requirements of Sec. 507.69.
* * * * *
(c) If you appeal the order, and FDA confirms the order, you must
comply with applicable requirements of this part within 120 calendar
days of the date of receipt of confirmation of the order.
0
16. Amend Sec. 507.69, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraph (a) introductory text and paragraph
(a)(1) to read as follows:
Sec. 507.69 Procedure for submitting an appeal.
(a) To appeal an order to withdraw an exemption applicable to a
qualified facility under Sec. 507.5(d), you must:
(1) Submit the appeal in writing to the FDA District Director in
whose district the facility is located (or, in the case of a foreign
facility, the Director of the Division of Compliance in the Center for
Veterinary Medicine), at the mailing address, email address, or
facsimile number identified in the order within 10 calendar days of the
date of receipt of the order;
* * * * *
0
17. Amend Sec. 507.71, as proposed to be added on October 29, 2013 (78
FR 64736), by revising paragraph (a) to read as follows:
Sec. 507.71 Procedure for requesting an informal hearing.
(a) If you appeal the order, you:
(1) May request an informal hearing; and
(2) Must submit any request for an informal hearing together with
your written appeal submitted in accordance with Sec. 507.69 within 10
calendar days of the date of receipt of the order.
* * * * *
0
18. Subpart D, as proposed to be added on October 29, 2013 (78 FR
64736), is amended by adding Sec. 507.85 to read as follows:
Sec. 507.85 Reinstatement of an exemption that was withdrawn.
(a) If the FDA District Director in whose district your facility is
located (or, in the case of a foreign facility, the Director of the
Division of Compliance in the Center for Veterinary Medicine)
determines that a facility has adequately resolved problems with the
conditions and conduct that are material to the safety of the animal
food manufactured, processed, packed, or held at the facility and that
continued withdrawal of the exemption is not necessary to protect
public (human and animal) health and prevent or mitigate a foodborne
illness outbreak, the FDA District Director in whose district your
facility is located (or, in the case of a foreign facility, the
Director of the Division of Compliance in the Center for Veterinary
Medicine) will, on his own initiative or on the request of a facility,
reinstate the exemption.
(b) You may ask FDA to reinstate an exemption that has been
withdrawn under the procedures of this subpart as follows:
(1) Submit a request, in writing, to the FDA District Director in
whose district your facility is located (or, in the case of a foreign
facility, the Director of the Division of Compliance in the Center for
Veterinary Medicine); and
(2) Present data and information to demonstrate that you have
adequately resolved the problems with the conditions or conduct that
are material to the safety of the animal food manufactured/processed,
packed, or held at your facility, such that continued withdrawal of the
exemption is not necessary to protect public (human and animal) health
and prevent or mitigate a foodborne illness outbreak.
(c) If your exemption was withdrawn under Sec. 507.60(a)(1) and
FDA later determines, after finishing the active investigation of a
foodborne illness outbreak, that the outbreak is not directly linked to
your facility, FDA will reinstate your exemption under Sec. 507.5(d),
and FDA will notify you in writing that your exempt status has been
reinstated.
(d) If your exemption was withdrawn under both Sec. Sec.
507.60(a)(1) and 507.60(2) and FDA later determines, after finishing
the active investigation of a foodborne illness outbreak, that the
outbreak is not directly linked to your facility, FDA will inform you
of this finding and you may ask FDA to reinstate your exemption under
Sec. 507.5(d) in accordance with the requirements of paragraph (b) of
this section.
Sec. 507.100 [Redesignated as Sec. 507.200]
0
19. Redesignate Sec. 507.100, as proposed to be added on October 29,
2013 (78 FR 64736), as Sec. 507.200.
0
20. Revise Sec. 507.102, as proposed to be added on October 29, 2013
(78 FR 64736), to read as follows:
Sec. 507.202 General requirements applying to records.
(a) Records must:
(1) Be kept as original records, true copies (such as photocopies,
pictures, scanned copies, microfilm, microfiche, or other accurate
reproductions of the original records), or electronic records, which
must be kept in accordance with part 11 of this chapter;
(2) Contain the actual values and observations obtained during
monitoring and as appropriate, during verification activities;
(3) Be accurate, indelible, and legible;
(4) Be created concurrently with performance of the activity
documented; and
(5) Be as detailed as necessary to provide history of work
performed.
(b) All records must include:
(1) The name and location of the plant or facility;
(2) The date and time of the activity documented;
(3) The signature or initials of the person performing the
activity; and
(4) Where appropriate, the identity of the product and the
production code, if any.
Sec. Sec. 507.106 and 507.108 [Redesignated as Sec. Sec. 507.206 and
507.208]
0
21. Redesignate Sec. Sec. 507.106 and 507.108, as proposed to be added
on October 29, 2013 (78 FR 64736), as Sec. Sec. 507.206 and 507.208,
respectively.
0
22. Subpart F, as proposed to be added on October 29, 2013 (78 FR
64736), is amended by adding Sec. 507.212 to read as follows:
Sec. 507.212 Use of existing records.
(a) Existing records (e.g., records that are kept to comply with
other Federal, State, or local regulations, or for any other reason) do
not need to be
[[Page 58520]]
duplicated if they contain all of the required information and satisfy
the requirements of this subpart F. Existing records may be
supplemented as necessary to include all of the required information
and satisfy the requirements of this subpart F.
(b) The information required by this part does not need to be kept
in one set of records. If existing records contain some of the required
information, any new information required by this part may be kept
either separately or combined with the existing records.
Dated: September 16, 2014.
Peter Lurie,
Associate Commissioner for Policy and Planning.
Note: The following appendix will not appear in the Code of
Federal Regulations.
Appendix
The supplemental notice of proposed rulemaking that is the
subject of this document includes a discussion of our
reconsideration of the classification of specific activities as
harvesting, packing, holding, or manufacturing/processing, when
conducted on farms or on farm mixed-type facilities (see the
discussion and Table 5 in section VII.C). Table 1 in this Appendix
compares the classification of on-farm activities as harvesting,
packing, holding, or manufacturing/processing in the 2013 proposed
rule for preventive controls to our current thinking on the
classification of these on-farm activities as a result of the
proposed revisions to the ``farm'' definition.
Table 1--Classification of Activities Conducted On-Farms and Farm Mixed-
Type Facilities
------------------------------------------------------------------------
Examples using
Examples using the 2013 the proposed
Classification proposed ``farm'' revisions to
definition* the ``farm''
definition
------------------------------------------------------------------------
Harvesting Activities Cooling RACs***
traditionally performed by (activity deleted Gathering RACs
farms for the purpose of because is not done on
removing RACs from growing RACs for animal food) Removing stems
areas and preparing them Filtering and husks from
for use as animal food. RACs*** (activity RACs
Harvesting does not include deleted because is not
activities that change a done on RACs for animal Shelling RACs
RAC into processed animal food)
food. Gathering RACs Sifting RACs
Removing stems
and husks from RACs Threshing RACs
Shelling RACs
Sifting RACs Trimming outer
Threshing RACs leaves from
Trimming of RACs
outer leaves from RACs
Washing RACs***
(activity deleted
because is not done on
RACs for animal food)
Packing: Placing animal food Coating RACs
in a container other than with wax/oil/resin for Labeling RACs
packaging the animal food the purpose of storage
and activities performed or transport *** Blending RACs
incidental to packing an (deleted because is not (e.g.,
animal food (e.g., done on RACs for animal blending
activities performed for food) different lots
the safe or effective Drying RACs for of the same
packing of that animal food the purpose of storage RAC such as
(such as sorting, culling or transport ** (would whole grains
and grading)), but does not change to only be that does not
include activities that classified as result in a
transform a RAC into a ``holding'') new commodity)
processed animal food. Labeling RACs
Mixing RACs Packaging RACs
Packaging a regardless of
farm's or farm mixed- ownership **
type facility's own RACs (expanded to
** (would no longer be include
limited to ``own RACs'') others' RACs)
Putting RACs or
individual unit cartons Putting RACs
into non-consumer or individual
containers unit cartons
Sorting/grading/ into non-
culling RACs consumer
Stickering RACs containers
Removing stems
and husks from
RACs ** (add'l
classification
)
Sifting RACS
** (add'l
classification
)****
Sorting/
culling/
grading RACs
Stickering
RACs
Using
pesticides on
RACs ** (add'l
classification
)
Holding: Storage of animal Drying/ Drying/
food and activities dehydrating RACs during dehydrating
performed incidental to storage (incidental to RACs
storage of an animal food packing or storing when (incidental to
(e.g., activities performed the drying/dehydrating storing when
for the safe or effective does not create a the drying/
storage of that food, and distinct commodity)** dehydrating
activities performed as a (would no longer be does not
practical necessity for the incidental to packing, create a
distribution of that animal would only be incidental distinct
food (such as blending of to holding) commodity)
the same commodity and Fumigating RACs
breaking down pallets)). during storage Fumigating
Holding does not include Sorting/culling/ RACs during
activities that change a grading RACs storage to
RAC into a processed animal Storing food control pests
food.
Sorting/
culling/
grading RACs
Storing animal
food
[[Page 58521]]
Manufacturing/Processing: Artificial
Making animal food from one ripening *** (this Canning
or more ingredients, or activity deleted because
synthesizing, preparing, is not done on animal Chopping
treating, modifying, or food)
manipulating animal food, Canning Cooking
including food crops or Chopping
ingredients. Examples of Coating RACs for Cooling
manufacturing/processing purposes other than Coring
activities are cutting, storage/transport *** (except field
peeling, trimming, washing, (this activity deleted coring)**
eviscerating, rendering, because is not done on (because field
cooking, baking, freezing, animal food) coring would
cooling, pasteurizing, Cooking be newly
homogenizing, mixing, Cooling classified as
formulating, milling, Coring harvesting)
grinding, extracting, Cracking
distilling, labeling, or Crushing Cracking
packaging. For farms and Cutting
farm mixed-type facilities, Distilling Crushing
manufacturing/processing Drying/
does not include activities dehydrating RACS to Cutting
that are part of create a distinct
harvesting, packing, or commodity Distilling
holding. Extracting Drying/
Formulating dehydrating
Freezing RACs to create
Grinding a distinct
Homogenizing commodity
Infusing
Irradiating Extracting
Labeling (other
than RACs) Formulating
Milling
Mixing Freezing
Packaging (other
than RACs) Grinding
Pasteurizing
Peeling Homogenizing
Rendering
Roasting Infusing
Salting
Slaughtering and Irradiating
post-slaughter
operations Labeling
Slicing (other than
Smoking RACs)
Sorting,
culling, grading (not Milling
incidental to packing or