[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  

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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]
------------------------------------------------------------------------
                                                                Total
                                                              (million)
------------------------------------------------------------------------
Original Total Annualized Costs without additional                   $65
 provisions................................................
Additional costs because of potential new provisions.......            4
Revised Total Annualized Costs.............................           69
Benefits...................................................        (\1\)
------------------------------------------------------------------------
\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
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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
------------------------------------------------------------------------
         Description                          Publication
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

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   Mixing
                               holding)                  
                               Trimming           Packaging
                               Washing            (other than
                                                          RACs)
                                                         
                                                          Pasteurizing
                                                         
                                                          Peeling
                                                         
                                                          Rendering
                                                         
                                                          Roasting
                                                         
                                                          Salting
                                                         
                                                          Slaughtering
                                                          and post-
                                                          slaughter
                                                          operations
                                                         
                                                          Slicing
                                                         
                                                          Smoking
                                                         
                                                          Sorting,
                                                          culling,
                                                          grading (not
                                                          incidental to
                                                          packing or
                                                          holding)
                                                         
                                                          Trimming
                                                         
                                                          Washing
------------------------------------------------------------------------
* Examples were included in Table 4, Table 5, and/or proposed Sec.  Sec.
    507.3 and 507.5(e) and (f) in the 2013 proposed rule for preventive
  controls and/or in the Draft Risk Assessment (Ref. 1).
** Activities listed in italics represent a change between the 2013
  ``farm'' definition and our current thinking in light of the proposed
  revisions to the ``farm'' definition.
*** Activities deleted because they are not typically performed in
  animal food.
**** add'l = additional.

    The following reference has 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. 
This reference is also available electronically at http://www.regulatons.gov.

1. 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.

[FR Doc. 2014-22445 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P