[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Proposed Rules]
[Pages 58524-58572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-22446]
[[Page 58523]]
Vol. 79
Monday,
No. 188
September 29, 2014
Part IV
Department of Health and Human Services
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Food and Drug Administration
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21 CFR Parts 16, 117, and 507
Current Good Manufacturing Practice and Hazard Analysis and Risk-Based
Preventive Controls for Food for Animals; Proposed Rule
Federal Register / Vol. 79 , No. 188 / Monday, September 29, 2014 /
Proposed Rules
[[Page 58524]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 1, 16, and 117
[Docket No. FDA-2011-N-0920]
RIN 0910-AG36
Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Human Food
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 Human
Food. In that 2013 proposed rule, we proposed to amend the CGMP
requirements to modernize them and to add requirements for certain
domestic and foreign facilities to establish and implement hazard
analysis and risk-based preventive controls for human food. We also
proposed to revise certain definitions in our current regulation for
Registration of Food Facilities to clarify the scope of an exemption
from registration requirements for ``farms'' and, in so doing, to
clarify which domestic and foreign facilities would be subject to the
proposed requirements for hazard analysis and risk-based preventive
controls for human food. We are taking this action because the
extensive input we have received from public comments has led to
significant changes in our current thinking on certain key provisions
of these proposed rules. 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.
FDA-2011-N-0920 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: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.
SUPPLEMENTARY INFORMATION:
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 Preventive Controls Rule
C. Definition of ``Retail Food Establishment''
II. Public Comments
A. Opportunities for Public Comment
B. Overview of Public Comments on the 2013 Proposed Preventive
Controls Rule
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. Conducting Packing and Holding Activities on Others' RACs
C. Field Coring as a Harvesting Activity
D. Drying/Dehydrating Raw Agricultural Commodities To Create a
Distinct Commodity
E. One General Physical Location
F. Proposed Revisions to the Exemption From CGMP Requirements
for ``Farms'' and Activities of ``Farm Mixed-Type Facilities'' That
Fall Within the ``Farm'' Definition
G. Comparing Proposed Requirements for Packing Produce Under the
2013 Proposed Preventive Controls Rule to Proposed Requirements for
Packing Produce Under the 2013 Proposed Produce Safety Rule
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/Food
Combinations
A. The 2013 Proposed Exemptions
B. Comments on the 2013 Proposed Exemptions for On-Farm Low-Risk
Activity/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/Food Combinations
IX. 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
X. Potential Requirements for Product Testing and Environmental
Monitoring
A. Our Request for Comment on Including Requirements for Product
Testing and
[[Page 58525]]
Environmental Monitoring in a Final Rule
B. Product Testing
C. Environmental Monitoring
XI. 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 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
XII. 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
XIII. 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
XIV. 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
XV. Other New and Revised Proposed Provisions
A. Proposed New Definitions
B. Proposed Revisions to Definitions
C. Proposed Editorial Changes
XVI. Holding Human Food By-Products Intended for Use in Animal Food
XVII. 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
XVIII. Paperwork Reduction Act of 1995
XIX. Analysis of Environmental Impact
XX. Comments
XXI. 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 human food, 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 a food
``facility.'' In this document we are proposing to revise several
previously proposed requirements, taking into account the comments we
have reviewed so far, because the extensive input we have received from
public comments has led to significant changes in our current thinking
on certain key provisions.
``Farms'' are exempt from the registration requirements and, thus,
would be exempt from the proposed requirements for hazard analysis and
risk-based preventive controls for human food. We are proposing to
revise the definition of ``farm,'' as well as definitions for three
activities (``harvesting'', ``holding'', and ``packing'') that play a
key role in determining whether an establishment is within the ``farm''
definition. The effect of the revised definitions would be that a farm
would no longer be required to register as a food facility merely
because it packs or holds raw agricultural commodities (RACs) grown on
another farm not under the same ownership. The revised definitions
would not create any new circumstances where a farm that would not have
been required to register under the previous proposal would now be
required to register.
In the previous proposal, 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 to the previous proposal 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
previous proposal but for which we had not included regulatory text in
the previous proposal. In this document we are providing an opportunity
for such public comment on potential requirements for product testing
programs, environmental monitoring programs, supplier programs, and
hazards that may be intentionally introduced for purposes of economic
gain, taking 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 previous proposal, 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 $1,000,000 in total annual sales of human food adjusted for
inflation).
Summary of the Major Provisions of the Supplemental Notice of Proposed
Rulemaking
The revised ``farm'' definition would continue to describe a farm
as an establishment devoted to the growing of crops, the raising of
animals, or both. However, the revised ``farm'' definition would no
longer limit packing and holding of RACs to the farm's own RACs;
instead, a ``farm'' could now pack and hold RACs grown on another farm
not under the same ownership. In addition, a farm could manufacture/
process RACs by drying/dehydrating to create a distinct commodity
(e.g., drying grapes to create raisins), and package and label the
dried commodity, as long as there was no additional processing. An
example of additional processing might include slicing fruit and then
drying it, which would require additional manufacturing/processing
prior to drying. Because drying/dehydrating RACs to create a distinct
commodity creates a processed food, the packing and holding of raisins
would be subject to the CGMP requirements for human food rather than to
standards that we have separately proposed to apply to produce RACs.
Given the nature of this processed food (i.e., dried RACs), we
tentatively conclude that the requirements we separately proposed for
packing and holding produce RACs would be sufficiently similar to the
CGMP requirements to make it appropriate to specify in the regulatory
text that compliance with the CGMP requirements may be achieved by
complying with subpart B or with the applicable requirements for
packing and holding produce RACs in the separate produce safety rule.
[[Page 58526]]
The previously proposed requirements for hazard analysis and risk-
based preventive controls applied a construct we 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, 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 proposed requirements for product testing 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 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 a ready-to-eat
product detected as a result of product testing, and records of product
testing.
The proposed requirements for environmental monitoring 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 food, and the nature
of the preventive control if contamination of a ready-to-eat 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 proposed requirements for a 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
roasts the nuts that a facility would use to manufacture an energy
bar). 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. 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
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 both a discount
rate of 3 percent and 7 percent, discounted over a 7 year period in the
following table. The revised proposed regulation uses a very small
business definition of $1,000,000 and includes potential additional
requirements for facilities subject to subpart C to institute risk-
based environmental monitoring, product testing and a supplier program
as appropriate to the 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, for the final rule we
anticipate making several modifications to our estimate of the cost of
our proposed rule (see section XVII).
As in our original proposal, we lack sufficient information to
fully estimate the proposed rule's likely benefits. Instead we attempt
to estimate the total economic burden of the domestic illnesses that
could potentially be prevented by this rule. We do not expect that all
of these illnesses will be prevented; rather, we expect that the rule
would prevent some portion from occurring. We estimate that there are
close to 1,000,000 illnesses each year that are attributable to FDA-
regulated
[[Page 58527]]
food products that would fall under the scope of this proposed rule.
The monetized cost of these illnesses is estimated to be nearly $2
billion. This ignores the costs to foreign firms and benefits to
foreign consumers.
For the proposed rule to break even, by which we mean for the
proposed rule to reduce the health burden to consumers by approximately
the same amount as the compliance costs to industry, and if we include
the costs to foreign firms but ignore the benefits to foreign
consumers, the rule would have to reduce the annual social cost of the
illnesses by approximately $471 million. We estimate that the average
cost per illness is $2,063, so reducing the cost of illness by $471
million requires reducing the number of illnesses by at least 228,000
each year.
Original and Revised Estimated Total Costs Based on Additional Provisions and Revised Facility Count
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20 or fewer 20 to 99 100 to 499 500 or more
employees employees employees employees Total
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Original Total Annualized Costs without additional $208 million $67 million $43 million $1 million $319 million*
provisions discounted at 7%.............................
Original Total Annualized Costs without additional $200 million $65 million $42 million $1 million $307 million*
provisions discounted at 3%.............................
Additional costs because of new provisions discounted at $19 million $20 million $10 million $2 million $52 million*
7%......................................................
Additional costs because of new provisions discounted at $19 million $20 million $10 million $2 million $52 million*
3%......................................................
Revised Total Annualized Costs discounted at 7%.......... $227 million $87 million $53 million $3 million $371 million*
Revised Total Annualized Costs discounted at 3%.......... $219 million $85 million $52 million $3 million $359 million*
Total Costs to Foreign Facilities (most likely cost) ................. ................. ................. ................. $100 million
annualized at 7%........................................
Total Costs to Foreign Facilities (most likely cost) ................. ................. ................. ................. $100 million
annualized at 3%........................................
Benefits................................................. ................. ................. ................. ................. Unquantified
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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 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-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 five
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 2013 proposed 78 FR 3646,
Practice and Hazard Analysis preventive January 16, 2013.
and Risk-Based Preventive controls rule.
Controls for Human Food.
Standards for the Growing, 2013 proposed 78 FR 3504,
Harvesting, Packing, and produce safety January 16, 2013.
Holding of Produce for Human rule.
Consumption.
Foreign Supplier Verification 2013 proposed FSVP 78 FR 45730, July
Programs (FSVP) for Importers rule. 29, 2013.
of Food for Humans and Animals.
Focused Mitigation Strategies To 2013 proposed 78 FR 78014,
Protect Food Against intentional December 24,
Intentional Adulteration. adulteration rule. 2013.
Current Good Manufacturing 2013 proposed 78 FR 64736,
Practice and Hazard Analysis animal food rule. October 29, 2013.
and Risk-Based Preventive
Controls for Food for Animals.
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B. 2013 Proposed Preventive Controls Rule
In the 2013 proposed preventive controls rule, we:
Proposed to amend our regulation for Current Good Manufacturing
Practice in Manufacturing, Packing, or Holding Human Food (CGMPs;
currently established in part 110 (21 CFR part 110)) to modernize it;
Proposed to adjust and clarify what activities fall within the
current exemption from the CGMP requirements for establishments engaged
solely in the harvesting, storage, or distribution of one or more RACs
based on experience and changes in related areas of the law since
issuance of the CGMP regulation;
Proposed to re-establish the provisions of current part 110 in new
part 117 (21 CFR part 117);
Proposed to delete some non-binding provisions of current part 110
and requested comment on whether to revise other non-binding provisions
to
[[Page 58528]]
establish new requirements in proposed part 117, or to simply retain
them as useful provisions of a comprehensive CGMP;
Requested comment on additional proposed revisions or
clarifications to our CGMP regulations, including whether to further
implement opportunities for CGMP modernization, such as on how best to
revise the current provisions for training;
Proposed to add, in newly established part 117, 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)
to establish and implement hazard analysis and risk-based preventive
controls for human food;
Proposed to add a definition for the term ``mixed-type
facilities,'' to add or modify definitions for certain activities
(i.e., for ``harvesting,'' ``holding,'' ``manufacturing/processing,''
and ``packing'' activities), and to revise the definition of ``farm''
as a conforming revision in light of the proposed new definition of
``harvesting'' in our current regulation for Registration of Food
Facilities (21 CFR part 1, subpart H; the section 415 registration
regulations) to clarify the scope of the exemption from the section 415
registration requirements for ``farms;''
Proposed to revise the definitions, in our current regulation
(implementing section 414 of the FD&C Act) for Establishment and
Maintenance of Records for Foods (21 CFR part 1, subpart J; the section
414 recordkeeping requirements);
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 117 as shown in Table 2:
Table 2--Proposed Subparts in New Part 117
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Subpart Title
------------------------------------------------------------------------
A...................................... General Provisions.
B...................................... Current Good Manufacturing
Practice.
C...................................... Hazard Analysis and Risk- Based
Preventive Controls.
D...................................... Modified Requirements.
E...................................... Withdrawal of an Exemption
Applicable to a Qualified
Facility.
F...................................... Requirements Applying to
Records That Must Be
Established and Maintained.
G...................................... Reserved.
------------------------------------------------------------------------
In the 2013 proposed preventive controls rule, we provided an
extensive 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 Human 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 preventive controls rule (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/Food Combinations for Activities
(Outside the Farm Definition) Conducted in a Facility Co-Located on a
Farm'' (the draft risk assessment) (78 FR 3824, January 16, 2013). The
purpose of the draft risk assessment was to provide a science-based
risk analysis of those activity/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 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.
We also issued a document correcting several typographical and
stylistic errors in the 2013 proposed preventive controls rule and a
mistake in the date of a reference (78 FR 17142, March 20, 2013). In
that correction document, we republished the Appendix in its entirety
(78 FR 17142 at 17143 through 17155; the corrected Appendix) because
all the references to the Appendix as published in the 2013 proposed
preventive controls rule (78 FR 3646 at 3812 through 3824) had been
numbered incorrectly.
C. Definition of ``Retail Food Establishment''
An establishment that meets the definition of ``retail food
establishment'' is exempt from the requirements of the section 415
registration regulations and, thus, from FSMA's requirements for hazard
analysis and risk-based preventive controls. Section 102(c) of FSMA
requires that we revise the definition of ``retail food establishment''
in Sec. 1.227 to clarify its intent. Some comments express concern
that we did not address the requirements of section 102(c) of FSMA in
the 2013 proposed preventive controls rule.
We are addressing the requirements of section 102(c) of FSMA in a
separate rulemaking and plan to issue a proposed rule to amend the
definition of ``retail food establishment'' in the section 415
registration regulations and the section 414 recordkeeping regulations
in a future issue of the Federal Register.
II. Public Comments
A. Opportunities for Public Comment
We requested comments on the 2013 proposed preventive controls rule
by May 16, 2013. We extended the comment periods for the 2013 proposed
preventive controls rule, 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 preventive controls rule, we
conducted numerous outreach activities. For example, we held three
public meetings to solicit oral stakeholder and public comments on the
2013 proposed preventive controls rule, 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 preventive controls rule (see Table 3) (Ref. 1) (Ref.
2) (Ref. 3) (Ref. 4) (Ref. 5) (Ref. 6). We also traveled across the
country and around the world to discuss the 2013 proposed preventive
controls rule, as well as the other foundational FSMA proposed rules
listed in section I.A, with persons who would be affected by them (Ref.
7) (Ref. 8) (Ref. 9).
[[Page 58529]]
Table 3--List of Federal Register Publications Regarding the 2013
Proposed Preventive Controls Rule
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Description Publication
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2013 proposed preventive controls rule, 78 FR 3646, January 16,
requesting comments by May 16, 2013. 2013.
Notice of availability of the draft risk 78 FR 3824, January 16,
assessment, requesting comments by 2013.
February 15, 2013.
Notice of public meeting (held in 78 FR 6762, January 31,
Washington D.C. on February 28, 2013) on 2013.
the 2013 proposed preventive controls
rule and the 2013 proposed produce safety
rule.
Notice of public meetings (held in 78 FR 10107, February 13,
Chicago, IL on March 11, 2013 and in 2013.
Portland, OR on March 27, 2013) on the
2013 proposed preventive controls rule
and the 2013 proposed produce safety rule.
Notice extending comment period, until May 78 FR 11611, February 19,
16, 2013, for the information collection 2013.
provisions of the 2013 proposed
preventive controls rule.
Reopening of the comment period, until May 78 FR 15894, March 13, 2013.
16, 2013, for the draft risk assessment.
Notice of correction for the 2013 proposed 78 FR 17142, March 20, 2013.
preventive controls rule.
Notice extending the comment period, until 78 FR 24691, April 26, 2013.
September 16, 2013, for the 2013 proposed
preventive controls rule and its
information collection provisions.
Notice extending the comment period, until 78 FR 24693, April 26, 2013.
September 16, 2013, for the draft risk
assessment.
Notice extending the comment period, until 78 FR 48636, August 9, 2013.
November 15, 2013, for the 2013 proposed
preventive controls rule and its
information collection provisions.
Notice extending the comment period, until 78 FR 69604, November 20,
November 22, 2013, for the 2013 proposed 2013.
preventive controls rule and its
information collection provisions.
------------------------------------------------------------------------
B. Overview of Public Comments on the 2013 Proposed Preventive Controls
Rule
We received more than 8000 submissions on the proposed rule by the
close of the comment period, each containing one or more comments. We
received submissions from diverse members of the public, including food
facilities (including facilities co-located on a farm); farms;
cooperatives; coalitions; trade organizations; consulting firms; law
firms; academia; public health organizations; public advocacy groups;
consumers; consumer groups; Congress, Federal, State, local, and tribal
Government Agencies; and other organizations. Some submissions included
signatures and statements from multiple individuals.
Comments address virtually every provision of the 2013 proposed
preventive controls rule, including our requests for comment on
including additional provisions that we did not include in the proposed
regulatory text. Although some comments focus on specific details of
the proposed requirements (such as whether the rule should define the
term ``allergen cross-contact'' rather than the term ``cross-
contact''), other comments are broad in nature (such as comments
addressing the overall framework of the proposed requirements for
hazard analysis and risk-based preventive controls in proposed subpart
C). Some comments question whether the proposed requirements reflected
a risk-based approach (such as comments about how the requirements for
hazard analysis and risk-based preventive controls would apply to
facilities co-located on farms). Some comments assert that additional
public comment would be warranted before any consideration of 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.
C. Our Decision To Issue a Supplemental Notice of Proposed Rulemaking
for Public Comment
In December 2013, we issued a statement noting the extensive input
we have received from produce farmers and others in the agricultural
sector on the 2013 proposed produce safety rule and the 2013 proposed
preventive controls rule (Ref. 8). We stated that we believe that
significant changes will be needed in key provisions of the two
proposed rules affecting small and large farmers, such as certain
provisions affecting mixed-use facilities (i.e., facilities co-located
on a farm). We also announced our intent to propose revised regulatory
requirements and request comment on them, allowing the public the
opportunity to provide input on our new thinking. We noted that there
may be other revisions to the proposed rules that we would issue for
public comment, and that we would determine the scope of the revised
proposals after we complete our initial review of written comments.
III. Scope of the Supplemental Notice and Our Request for Public
Comment
In this document, we are proposing:
Modifications to our proposed revisions to the definitions, in the
section 415 registration regulations, for ``farm,'' ``harvesting,''
holding,'' and ``packing,'' with conforming changes in the section 414
recordkeeping regulations and the proposed preventive controls rule;
Modifications to our proposed revisions to the current exemption,
in the CGMP regulations, for establishments engaged solely in the
harvesting, storage, or distribution of one or more RACs;
Revisions to several definitions we proposed to apply to the
requirements for hazard analysis and risk-based preventive controls,
including definitions for ``environmental pathogen,'' ``hazard,''
``reasonably foreseeable hazard,'' and ``very small business'';
New definitions for ``significant hazard,'' ``pathogen,'' and
``you'';
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; and
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
[[Page 58530]]
that all necessary preventive controls be established at CCPs for all
hazards that a facility addresses in its food safety plan;
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);
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.
In this document, we also are informing stakeholders of a
supplemental notice of proposed rulemaking, published elsewhere in this
issue of the Federal Register, to amend the 2013 proposed animal food
rule. That supplemental notice includes proposed revisions that would
address comments about the practice of human food manufacturers sending
by-products to local farmers or animal food manufacturers for use as
animal food.
We discuss these proposed requirements in sections V through XV.
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 a preliminary review of
the comments. We will complete our review of comments previously
submitted and consider the comments responsive to this supplemental
notice 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 preventive controls rule, 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. We focused on
the framework that governs whether an establishment that grows and
harvests crops or raises animals 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, we 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 preventive
controls rule, section 103 of FSMA directs us to conduct rulemaking to
clarify the on-farm manufacturing, processing, packing and holding
activities that would trigger a requirement for an establishment that
is also a farm to register as a food facility and, thus, be subject to
the requirements for hazard analysis and risk-based preventive controls
with regard to its non-farm activities (78 FR 3646 at 3674). In the
2013 proposed preventive controls rule, 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.
In the 2013 proposed preventive controls rule, we also articulated
a comprehensive set of organizing principles that formed the basis for
proposed revisions to definitions that classify activities on-farm and
off-farm in the section 415 registration regulations (the 2013
organizing principles; see Table 3 in the 2013 proposed preventive
controls rule). Because these definitions also are established in the
section 414 recordkeeping regulations, these organizing principles also
would form the basis for proposed revisions to definitions that
classify activities on-farm and off-farm in the section 414
recordkeeping regulations.
In the 2013 proposed preventive controls rule, we proposed to add a
definition for the term ``mixed-type facilities,'' to add or modify
definitions for certain activities (i.e., for ``harvesting,''
``holding,'' ``manufacturing/processing,'' and ``packing'' activities),
and to revise the definition of ``farm'' as a conforming revision in
light of the proposed new definition of ``harvesting.''
In sections V and VI, we discuss comments on these and other
provisions of the 2013 proposed preventive controls rule that are
leading us to propose revised definitions for ``farm,'' ``harvesting,''
``packing,'' and ``holding''; and re-classify some activities as
harvesting, packing, or holding. Briefly, the proposed changes would:
Provide for on-farm packing and holding of RACs to remain within
the farm definition regardless of ownership of the RACS;
Include, within the ``farm'' definition, a description of packing
activities that include packaging RACs grown or raised on a farm
without additional manufacturing/processing;
Provide for ``field coring'' as an example of a harvesting activity
to make clear that on farm ``field coring'' of a RAC is an activity
that is within the ``farm'' definition;
[[Page 58531]]
Provide that activities performed incidental to packing a food
would be ``packing'' activities;
Provide that activities performed incidental to holding a food
would be ``holding'' activities;
Provide for drying/dehydrating RACs to create a distinct commodity
(such as the on-farm drying of grapes to produce raisins), and
packaging and labeling such commodities, without additional
manufacturing/processing, to remain within the farm definition;
Seek comment on whether we should retain, remove, or modify the
phrase ``in one general physical location'' in the ``farm'' definition;
Subject the packaging, packing, and holding of dried RACs by farms
and farm mixed-type facilities to the CGMP requirements in subpart B of
proposed part 117 as well as provide that compliance with these CGMP
requirements may be achieved by complying with the applicable
requirements for packing and holding produce RACs in the separate
produce safety rule; and
Reconsidered the classification of specific activities as
harvesting, packing, holding, or manufacturing/processing, when
conducted on farms or on farm mixed-type facilities. These changes in
activity classification 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 a food facility,
but would not result in any new circumstance where a farm would now be
required to register as a food facility.
Elsewhere in this issue of the Federal Register, we are issuing a
supplemental notice of proposed rulemaking to amend the 2013 proposed
animal food rule. That supplemental notice includes a discussion of
farming models for raising animals, including contract farming, fully
vertically integrated farming, and cooperative farming. That
supplemental notice asks 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 and, if so, what revisions
to the farm definition would be necessary.
V. The ``Farm'' Definition
In this section of this document, we are:
Proposing modifications to our proposed revisions to the ``farm''
definition;
Proposing modifications to our proposed revisions to the
definitions of ``harvesting,'' ``holding,'' and ``packing'' as
conforming amendments to the revised ``farm'' definition''; and
Proposing modifications to our proposed revisions to the current
exemption, in the CGMP regulations, for establishments engaged solely
in the harvesting, storage, or distribution of one or more RACs.
We are reopening the comment period with respect to these revised
definitions (proposed Sec. 117.3) and this revised exemption (proposed
Sec. 117.3(k)). See section VI for additional revisions that we are
proposing to the definitions of ``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, 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 proposed 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 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.
B. Conducting Packing and Holding Activities on Others' RACs
1. Comments
Some stakeholders expressed concern, in public sessions and in
written comments, about how the proposed requirements for packing and
holding RACs would apply to a farm that would be subject to the
requirements for hazard analysis and risk-based preventive controls
because the farm packs or holds produce grown on others' farms.
Comments assert that classifying establishments as being within the
``farm'' definition, or outside the ``farm'' definition, based on who
owns the RACs being packed is not a risk-based classification. These
comments also compare the requirements that would apply to a farm when
packing produce in accordance with the 2013 proposed preventive
controls rule to the requirements that would apply to a farm when
packing produce in accordance with the 2013 proposed produce safety
rule. In general, these comments express concern about the lack of
clarity and consistency in the requirements for packing and holding
RACs under the 2013 proposed preventive controls rule and the 2013
proposed produce safety rule. Some of these comments assert that
treating on-farm packing and holding of RACs differently depending on
whether the RACs are grown on that farm (or another farm under the same
ownership) or grown on a different farm under different ownership,
fails to reflect modern, cooperative farming practices and to be risk-
based. Comments also assert that it unreasonable to force many farms to
comply with two different sets of requirements depending on whether
they are packing and holding their own produce or packing and holding
produce from another farm. In essence, comments assert it would be more
appropriate for farm activities such as packing and holding produce to
be treated consistently under the two rules. Comments also generally
assert that the requirements in the 2013 proposed produce safety rule
for packing and holding activities (which would not require hazard
analysis and risk-based preventive controls) are more appropriate for
farms than the requirements in the 2013 proposed preventive controls
rule for packing and holding activities (which would require
[[Page 58532]]
hazard analysis and risk-based preventive controls).
Some comments find it confusing for the definition of ``farm'' to
start by describing a farm as a ``facility'' in light of the definition
of ``facility'' in section 415(o)(2) of the FD&C Act as a facility
required to register under section 415 of the FD&C Act.
2. Proposed Revisions to the Definitions of ``Farm,'' ``Harvesting,''
``Holding,'' and ``Packing''
In the rulemakings to establish the section 415 registration
regulations and the section 414 recordkeeping regulations, we defined
``farm'' with the goal of doing so in a manner recognizing the
traditional activities of establishments commonly recognized to be
farms (see the discussions at 78 FR 3646 at 3676-3677 and 3679). As
already noted (see section V.A), we proposed to expand the definition
of ``packing'' to include activities traditionally performed by a farm
to prepare its own RACs for storage and transport and to expand the
definition of ``holding'' to include activities traditionally performed
by a farm for the safe or effective storage of its own RACs. Comments
assert that the packing and holding of others' RACs is a traditional
and common activity by farms and that the definition should not
distinguish between activities performed by a farm on its own RACs and
activities performed on RACs from other farms.
We tentatively conclude that it is appropriate for packing and
holding of RACs, including produce, conducted on farms to remain within
the farm definition. This would result in packing and holding of
covered produce being subject to the proposed produce safety rule,
regardless of whether the activity is conducted on the farm's own
produce or whether the activity is conducted on others' produce. This
also would have consequences beyond the preventive controls rule and
the produce safety rule. For example, the revised ``farm'' definition
would be established in both the section 415 registration regulations
and in the section 414 recordkeeping regulations (see the revised
regulatory text for proposed Sec. Sec. 1.227 and 1.328, respectively).
Under the revised ``farm'' definition in the section 414 recordkeeping
regulations, an establishment that packs and holds others' RACs would
no longer be required to establish and maintain records identifying the
immediate previous sources of those RACs and immediate subsequent
recipients of those RACs. In addition, the scope of covered
establishments would change for other statutory requirements that
depend, in relevant part, on whether an establishment is a facility
subject to the section 415 registration regulations. For example, this
would be the case for requirements for the Reportable Food Registry
(under section 417 of the FD&C Act), mandatory recall (under section
423 of the FD&C Act), and regulations that we have proposed to
establish regarding intentional contamination related to terrorism
(under sections 418 and 420 of the FD&C Act; see the proposed
intentional adulteration rule, 78 FR 78014). We tentatively conclude
that impacts such as these, while not always optimal, are necessary to
establish a sensible framework of risk-based regulations that both
implement FSMA and reflect common farm activities. Elsewhere in this
issue of the Federal Register, a supplemental notice of proposed
rulemaking regarding the produce safety rule (the produce safety
supplemental notice) discusses impacts such as these, including a
request for comment on whether to include in the final produce safety
rule a requirement that a farm supplying produce to another farm that
will pack or hold that produce should provide to the farm that receives
the produce its name, complete business address, and description of the
produce in any individual shipment. The produce safety supplemental
notice also requests comment on whether it would be appropriate to also
require the farm that receives the shipment maintain such record of
information and, if so, for what specified period of time.
Therefore, taking into account the comments we have reviewed so far
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 RACs 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.'' As a
conforming change relevant to this substitution, we are adding to the
``farm'' definition the criterion, in the definition of ``facility,''
that the establishment is ``under one ownership,'' to retain that
aspect of the current ``farm'' definition in the revised definition.
For additional discussion about manufacturing/processing activities
that would make an establishment subject to the section 415
registration regulations, see sections V.D and VII.
We also are proposing that the packing activities (which may
include packaging) that we 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. Packaging activities would continue to be considered
manufacturing/processing (78 FR 3646 at 3681-3682); however, packaging
a RAC would not transform the RAC into a processed food (see the
discussion in the 2013 proposed preventive controls rule about whether
an activity transforms a RAC into a processed food (78 FR 3646 at 3678-
3679)). Importantly, we are proposing limitations on what would be
included within this addition to the ``farm'' definition. This proposed
provision would not provide that packaging RACs would remain within the
``farm'' definition if the packaging includes additional manufacturing/
processing (e.g., the application of ``modified atmosphere
packaging''). Such additional processing activities are not akin to
packing (see the discussion in the 2013 proposed preventive controls
rule (78 FR 3646 at 3686) that certain packaging activities conducted
on a farm are akin to packing).
We are not proposing any changes to the ``farm'' definition that we
would establish in part 117, because the proposed ``farm'' definition
for the purpose of part 117 simply referred to the ``farm'' definition
in the section 415 registration regulations.
The revised ``farm'' definition would require conforming changes to
the proposed definitions of ``harvesting,'' ``holding,'' and
``packing'' (in the section 415 registration regulations, the section
414 recordkeeping regulations, and the proposed preventive controls
rule) to remove limitations that the food be grown on the same farm or
a farm under the same ownership. (See the revised regulatory text for
proposed Sec. Sec. 1.227, 1.328, and 117.3). In addition:
[[Page 58533]]
The revised regulatory text for the definition of ``harvesting''
includes ``field coring'' as an additional example of a harvesting
activity. See section V.C for a discussion of this proposed additional
example.
The revised regulatory text for the definition of ``holding''
includes revisions that we are proposing in response to comments about
how the definition of ``holding'' would apply to facilities such as
grain elevators and warehouses. See section VI.A through VI.E for a
discussion of those proposed revisions.
The revised regulatory text for the definition of ``packing''
includes changes that we are proposing to provide for activities
performed incidental to packing a food. See section VI.F for
discussions of those proposed revisions.
The revised definitions of ``farm,'' ``harvesting,'' ``holding,''
and ``packing'' would, if finalized, require changes to guidance
documents we issued regarding the section 415 registration regulations
and the section 414 recordkeeping regulations, including specific
examples of circumstances that would make an establishment subject to
those requirements (e.g., Ref. 10, Ref. 11, Ref. 12, and Ref. 13). We
intend to update affected guidance documents to reflect the final
definitions.
C. Field Coring as a Harvesting Activity
1. Comments
Some comments ask us to specify that activities such as ``core in
field'' and ``clean and core'' are considered harvesting, because these
activities are no different from an example (i.e., ``trimming of outer
leaves of'') included in the regulatory text of the definition of
``harvesting.''
2. Proposed Revision to the Definition of ``Harvesting''
We are proposing revisions to the definition of ``harvesting'' in
addition to the revisions, discussed in section V.B.2, that would be
conforming amendments in light of the revised ``farm'' definition. We
are proposing to 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. Under the
revised ``harvesting'' definition, it would be clear that 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 conducts field coring of produce. The revised definition of
``harvesting'' would be included in the section 415 registration
regulations, the section 414 recordkeeping regulations, and the
preventive controls rule. In this section of this document, we are
reopening the comment period with respect to including ``field coring''
as an example of a harvesting activity in this revised definition of
``harvesting'' (proposed Sec. 117.3).
D. Drying/Dehydrating Raw Agricultural Commodities To Create a Distinct
Commodity
1. Comments
Some comments refer to our discussion, in the 2013 proposed
preventive controls rule, about guidance jointly developed by FDA and
the U.S. Environmental Protection Agency (EPA) regarding whether or not
various activities transform RACs into processed foods, including a
joint conclusion that drying a RAC causes it to become a processed
food, unless the drying is for the purpose of facilitating storage or
transportation of the commodity (78 FR 3646 at 3678-3679). In our
discussion, we described a series of policy statements and guidance
documents, issued by FDA and EPA regarding whether or not various
activities transform RACs into processed foods (78 FR 3646 at 3678-
3679). We noted that FDA and EPA have jointly concluded that drying a
RAC causes it to become a processed food, unless the drying is for the
purpose of facilitating storage or transportation of the commodity
(see, e.g., (Ref. 14). We referenced a policy statement issued by EPA
on the status of dried commodities as RACs (the 1996 EPA policy
statement; 61 FR 2386, January 25, 1996). We also gave two examples of
when we would consider that drying a RAC created a processed food: (1)
Drying grapes to create raisins; and (2) drying fresh herbs (such as
peppermint) to create dried herbs, because in both these instances
drying creates a distinct commodity and therefore a processed food.
The comments contrast the growing and harvesting (including drying)
of ``natural condition raisins'' (produced with sun-drying or
artificial dehydration) with raisins subject to additional processing
and packing (e.g., sorting, cleaning or seeding) at an off-farm
facility. The comments maintain that the traditional activities of
raisin grape farmers associated with growing and harvesting ``natural
condition raisins'' on farm are completely separate and distinct from
the processing and packing of ``processed raisins'' at a raisin
processing facility. They note that raisin grape farmers generally dry
their grapes either by cutting the grape clusters and placing them on
trays to be naturally sun dried, or by allowing the grapes to dry
naturally on the vine. In both instances, there is no intervention by
the farmer in the drying process; rather, the drying process occurs
naturally through the action of the sun. These comments ask us to
recognize this distinction and provide in the final rule that on-farm
activities such as drying ``natural condition raisins'' in the field
are exclusively subject to the produce safety rule and that processing
facility operations are subject to the preventive controls rule. They
also specifically mention the 1996 EPA policy statement and ask us to
determine that it does not apply for the purposes of implementing FSMA.
2. Proposed Revisions to the ``Farm Definition'' Regarding Drying/
Dehydrating RACs To Create a Distinct Commodity When the Drying/
Dehydrating Is Akin to Harvesting and There Is No Additional Processing
The processes described in the comments for drying grapes to
``natural condition raisins'' are akin to other harvesting activities
traditionally conducted by farms on RACs grown and harvested on farms,
because they 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 (see 78 FR 3646 at 3681 and the proposed
definition of harvesting in proposed Sec. 117.3).
We continue to consider that drying a RAC to create a distinct
commodity causes it to become a processed food and, thus, is a
manufacturing/processing activity for the purpose of the section 415
registration regulations. However, to the extent that the comments are
asking us to determine that drying a RAC to create a distinct commodity
can, under circumstances such as those described in the comments,
remain within the ``farm'' definition, we tentatively conclude that it
is appropriate to do so, provided that the drying/dehydrating process
is akin to harvesting. However, we would continue to classify drying
RACs to create a distinct commodity as manufacturing/processing rather
than re-classify this activity as harvesting.
[[Page 58534]]
We do not consider it necessary or prudent to classify this activity in
two different ways for the purposes of the ``farm'' definition and
determining our responsibilities for antimicrobial substances.
To provide for drying/dehydrating that is akin to harvesting to
remain within the farm definition, taking into account the comments we
have reviewed so far we are proposing that farms include establishments
that, in addition to growing and harvesting crops, raising animals, or
both, manufacture/process RACs by drying/dehydrating the RACs to create
a distinct commodity, and/or packaging and/or labeling such
commodities, without additional manufacturing/processing (see the
revised regulatory text for the ``farm'' definition in proposed
Sec. Sec. 1.227 and 1.328). This revised ``farm'' definition would
specifically address this circumstance because otherwise it would not
be within the ``farm'' definition. Drying/dehydrating that is akin to
harvesting would not trigger the requirement to register as a facility
and would not trigger the requirements for hazard analysis and risk-
based preventive controls. Likewise, packaging and/or labeling the
dried commodities (which are processed food), would not trigger the
requirement to register as a facility and would not trigger the
requirements for hazard analysis and risk-based preventive controls. As
a companion change, we are proposing that the ``farm'' definition
explicitly provide that packing and holding the dried commodities
(which are processed food) is within the ``farm'' definition. Whether a
farm would be subject to the produce safety rule would depend on
factors included in the produce safety rule, such as whether the RACs
satisfy criteria for ``covered produce.''
Importantly, we are proposing limitations on when this special
circumstance would apply. This proposed provision would not provide
that drying/dehydrating fruit would remain within the ``farm''
definition if the dried/dehydrated fruit is subject to additional
manufacturing/processing, such as cutting the fruit or applying
sulfites (e.g., when manufacturing/processing dried apples). Such
additional processing activities are not akin to harvesting. They also
are not necessary for safe storage of the crop (which would be holding;
see sections VI.C., VI.E, and VII.C and Table 1 in the Appendix to this
document). A farm that also manufactures/processes products such as
dried, cut apples would be a farm mixed-type facility, subject to the
section 415 registration regulations and FSMA's requirements for hazard
analysis and risk-based preventive controls for such activities.
E. One General Physical Location
1. Comments on Whether the ``Farm'' Definition Should Specify That a
Farm Is in ``One General Physical Location''
Some comments emphasize 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 physical location'' in the ``farm'' definition. One suggested
modification is to replace the phrase ``in one general physical
location'' with an explanatory sentence, such as one clarifying that a
farm may consist of one or more parcels of land (or water) and may
include one or more structures (e.g., outbuildings, barns, greenhouses,
etc.).
2. Request for Additional Comment on Whether the ``Farm'' Definition
Should Specify That a Farm Is in ``One General Physical Location''
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 seeking comment on whether we should retain, remove, or
modify 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. For example, elsewhere in
this issue of the Federal Register the produce safety supplemental
notice seeks comment on how we should interpret ``in one general
physical location'' for the purposes of enforcing that rule. The
produce safety supplemental notice explains that specifying that a farm
is in ``one general physical location'' could impact classification of
farms subject to the produce safety rule as a ``small business'' or
``very small business'' and, thus affect the compliance date for that
farm.
F. Proposed Revisions to the Exemption From CGMP Requirements for
``Farms'' and Activities of ``Farm Mixed-Type Facilities'' That Fall
Within the ``Farm'' Definition
1. 2013 Proposed Revisions to the Exemption From the CGMP Requirements
for Establishments Engaged Solely in the Harvesting, Storage, or
Distribution of One or More RACs
In the 2013 proposed preventive controls rule, we proposed to
adjust and clarify what activities fall within the current exemption
from the CGMP requirements for establishments engaged solely in the
harvesting, storage, or distribution of one or more RACs (``RAC
exemption'') based on experience and changes in related areas of the
law since issuance of the CGMP regulation. We proposed to provide that
the CGMP requirements of subpart B would not apply to ``farms,''
activities of ``farm mixed-type facilities'' that fall within the
``farm'' definition, or the
[[Page 58535]]
holding or transportation of one or more RACs (proposed Sec.
117.5(k)).
In the 2013 proposed produce safety rule, we proposed to implement
section 419 of the FD&C Act (standards for produce safety) by
establishing, in part 112, standards for the growing, harvesting,
packing, and holding of produce for human consumption. The proposed
standards for produce safety would apply only to RACs (see proposed
Sec. 112.1(a) and section 419(a)(1)(A) of the FD&C Act).
2. Consequential Revision to the RAC Exemption in Light of Proposed
Changes to the ``Farm'' Definition
As discussed in section V.D of this document, we are proposing that
an establishment that is devoted to the growing and harvesting of
crops, the raising of animals, or both can remain within the farm
definition if it dries/dehydrates RACs to create a distinct commodity,
and/or packages and/or labels such commodities, without additional
manufacturing/processing. A farm that does so would transform a RAC
into a processed food. The growing and harvesting of produce RACs that
would be covered by the proposed produce safety rule would be subject
to the standards for produce safety, but the dried commodities that are
processed food would not. Like any other processed food, such dried
commodities would be subject to the CGMP requirements (proposed subpart
B) and would not be eligible for a ``RAC exemption,'' whether the
current RAC exemption in Sec. 110.19 or the proposed ``RAC exemption''
in proposed Sec. 117.5(k).
Therefore, as a consequence of our proposal to provide for drying/
dehydrating that is akin to harvesting to remain within the farm
definition, we also are proposing to revise the exemption from CGMP
requirements for ``farms'' and activities of ``farm mixed-type
facilities'' that fall within the ``farm'' definition to provide that
if a ``farm'' or ``farm mixed-type facility'' dries/dehydrates RACs to
create a distinct commodity, the CGMP requirements apply to the
packaging, packing, and holding of the dried commodities. As discussed
in section V.G of this document, we tentatively conclude that the
specific steps that are necessary to ensure the safety of produce that
an establishment packs and holds would be the same regardless of the
specific regulatory framework applicable to the establishment. Given
the nature of the processed food that would be subject to the CGMP
requirements (i.e., dried RACs), we tentatively conclude that the
requirements we separately proposed for packing and holding produce
RACs would be sufficiently similar to the CGMP requirements to make it
appropriate to specify in the regulatory text that compliance with the
CGMP requirements may be achieved by complying with subpart B or with
the applicable requirements for packing and holding produce RACs in the
separate produce safety rule. However, we do not intend to issue a
final rule on this specific option for achieving compliance with the
CGMP requirements that would apply to processed food produced through
drying/dehydrating RACs until we issue the final produce safety rule.
3. Comments on the Proposed RAC Exemption
Some comments ask us to exempt the harvest and immediate transport
of raw fishery commodities from the CGMP requirements. Other comments
ask us to exempt facilities that conduct hulling and drying operations
on shell nuts from the CGMP requirements.
4. Proposed Additional Revisions to the RAC Exemption To Clarify
Applicability to Certain RACs
We are proposing to clarify how the RAC exemption applies to
seafood RACs by specifying that subpart B does not apply to fishing
vessels that are not subject to the registration requirements of part
1, subpart H of this part in accordance with Sec. 1.226(f). Section
1.226(f) describes fishing vessels that are exempt from the
registration requirements as those that not only harvest and transport
fish but also engage in practices such as heading, eviscerating, or
freezing intended solely to prepare fish for holding on board a harvest
vessel. Section 1.226(f) also specifies that fishing vessels otherwise
engaged in processing fish are subject to the registration
requirements, and describes ``processing'' for the purpose of
determining the exemption to mean handling, storing, preparing,
shucking, changing into different market forms, manufacturing,
preserving, packing, labeling, dockside unloading, holding, or heading,
eviscerating, or freezing other than solely to prepare fish for holding
on board a harvest vessel. The practices identified in Sec. 117.226(f)
(heading, eviscerating, or freezing intended solely to prepare fish for
holding on board a harvest vessel) that warrant an exemption from
registration are activities conducted by establishments engaged solely
in the harvesting, storage, or distribution of one or more RACs and,
thus, fall within the current RAC exemption in Sec. 110.19.
We also are proposing to clarify how this exemption applies to
activities commonly conducted on nuts at a facility that is not a farm
or farm-mixed type facility by specifying that subpart B does not apply
to hulling, shelling, and drying nuts (without manufacturing/
processing, such as roasting nuts). Hulling, shelling, and drying nuts
(without additional manufacturing/processing), are activities conducted
by establishments engaged solely in the harvesting, storage, or
distribution of one or more RACs and, thus, fall within the current RAC
exemption in Sec. 110.19.
G. Comparing Proposed Requirements for Packing Produce Under the 2013
Proposed Preventive Controls Rule to Proposed Requirements for Packing
Produce Under the 2013 Proposed Produce Safety Rule
1. Comments
Some stakeholders expressed concern, in public sessions and in
written comments, about the proposed requirements that would apply to
an off-farm facility that packs and holds produce. These comments focus
on how the proposed requirements for an off-farm facility that packs
and holds produce under the requirements of the 2013 proposed
preventive controls rule would be different from the requirements,
under the 2013 proposed produce safety rule, that would apply to on-
farm packing and holding of produce. These comments assert that the
status of an establishment as a facility subject to the section 415
registration requirements should not be used as justification to
subject packing and holding activities to different standards if there
is no risk-based reason to do so. Some comments assert that the
standards described in the 2013 proposed produce safety rule are ``more
than adequate'' for the safe handling and packing of raw, intact fresh
produce, regardless of commodity, size of operation, or source of
produce. These comments also assert that there is no evidence to
suggest that different requirements for off-farm establishments that
pack and hold produce are needed to prevent contamination.
2. Summary of the Similarities and Differences for Off-Farm Packing and
Holding Compared to On-Farm Packing and Holding
The specific steps that are necessary to ensure the safety of
produce that an establishment packs and holds generally would be the
same regardless of whether the establishment is on-farm or off-farm.
For example, several of the
[[Page 58536]]
CGMP requirements that would apply to an off-farm packing facility
(e.g., provisions for employee health and hygiene, the plant and its
grounds, sanitary operations and facilities, and equipment and
utensils) have an analogous counterpart in the 2013 proposed produce
safety rule. In addition, although an off-farm packing facility would
be required to establish and implement a food safety plan, we expect
that its food safety plan would focus on a few key preventive controls,
including some that would have counterparts in the proposed produce
safety rule. For example, we expect that the food safety plan for an
off-farm packing facility would include preventive controls such as
maintaining and monitoring the temperature of water used during
packing. These preventive controls would have counterparts under the
2013 proposed produce safety rule (see, e.g., proposed Sec.
112.46(c)). We also expect that an off-farm packing facility would
establish sanitation controls to address the cleanliness of food-
contact surfaces (including food-contact surfaces of utensils and
equipment) and the prevention of cross-contamination from insanitary
objects and from personnel to food, food packaging material, and other
food-contact surfaces. See the discussion in the 2013 proposed
preventive controls rule about an outbreak of listeriosis from
cantaloupes, which was attributed to insanitary conditions at a
facility that washed, packed, cooled, and stored intact cantaloupes (78
FR 3646 at 3814). On-farm packing facilities would be subject to
similar, but not identical, requirements (see e.g., proposed Sec.
112.111(b) for cleanliness of food contact surfaces and proposed Sec.
112.113 for protection against contamination).
An off-farm packing facility also would be required to establish
and implement appropriate preventive control management components,
including monitoring, corrections or corrective actions, and
verification as appropriate to the nature of the preventive control,
and would establish and maintain records relative to these preventive
controls. Some of these management components also would have
counterparts under the 2013 proposed produce safety rule (see, e.g.,
proposed Sec. 112.46(a) and (b)). Moreover, we consider it likely that
industry associations and coalitions would develop a generic food
safety plan applicable to off-farm packing and holding of produce
covered by the produce rule, based in large part on the final
provisions of the produce safety rule. An off-farm packing and holding
facility would be able to start from such a generic food safety plan,
or to start from the provisions of the final produce safety rule, in
generating its own food safety plan, and to tailor its own food safety
plan to its particular circumstances, such as the commodities it packs
and holds.
The FD&C Act makes the status of an establishment as a facility
subject to the section 415 registration requirements, rather than a
farm, relevant to which requirements apply to packing and holding
activities. Section 418(a) of the FD&C Act, which applies to facilities
required to register, requires the owner, operator, or agent in charge
of a facility to evaluate the hazards that could affect food
manufactured, processed, packed, or held by such facility, identify and
implement preventive controls, monitor the performance of those
controls, and maintain records of this monitoring as a matter of
routine practice. Section 418(h) of the FD&C Act requires the owner,
operator, or agent in charge of a facility to prepare a written plan
that documents and describes the procedures used by the facility to
comply with the requirements of section 418 of the FD&C Act (see
section 418(h) of the FD&C Act). In contrast, section 419 of the FD&C
Act directs FDA (rather than the owner, operator, or agent in charge of
a farm) to establish science-based minimum standards for the safe
production and harvesting of those types of fruits and vegetables,
including specific mixes or categories of fruits and vegetables, that
are RACs for which FDA has determined that such standards minimize the
risk of serious adverse health consequences or death.
VI. Definitions of ``Holding'' and ``Packing''
A. 2013 Proposed Definition of ``Holding''
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 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. 117.5(j); see discussion at 78
FR 3646 at 3709). 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), unpasteurized
shell eggs, and unpasteurized milk 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 3646 at 3709).
Second, we proposed to exempt a ``facility solely engaged in the
storage of packaged food 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. 117.7(a); see
discussion at 78 FR 3646 at 3713). We intended this provision to
exempt, for example, facilities that store packaged food in containers
in a warehouse. However, a facility solely engaged in the storage of
packaged 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. 117.7(b) and Sec.
117.206).
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.2, 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. 117.3).
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 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. 117.5(j) because
most such facilities conduct a variety of activities in addition to
``storage.'' For example, comments note that grain elevators typically
conduct the following activities that could be characterized as being
practical necessities, either for the
[[Page 58537]]
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 recommend 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 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:
Affix tracking labels;
Transport to a storage location in the warehouse;
Hold non-food products, including toys and beauty aids;
Break down pallets of packaged 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 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 food (such as transport and storage of non-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, we
tentatively conclude that we should revise the definition of
``holding'' to encompass activities performed incidental to storage of
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). In addition to the activities specifically
identified in the comments, we are aware of other activities (Ref. 15)
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.
The revised definition of ``holding'' would be included in the
section 415 registration regulations, the section 414 recordkeeping
regulations, and the preventive controls rule. Our previously proposed
revisions already included activities traditionally performed by farms
and farm mixed-type facilities for the safe or effective storage of
RACs (78 FR 3646 at 3681). In this document, we are proposing to revise
the definition of holding in all three regulations to:
Clarify that holding 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 commodity));
Broaden ``activities . . . performed for the safe or effective
storage of raw agricultural commodities'' to apply to all food, not
just RACs;
Broaden ``activities . . . performed for the safe or effective
storage'' to apply to all establishments that hold 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 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 feed).
As discussed in section V.B.2, 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'').
The revised definition of ``holding'' would now be a one-part
definition that applies to all facilities that hold 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. See the proposed regulatory text
for the definition of holding in proposed Sec. Sec. 1.227, 1.328, and
117.3.
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. 117.5(j)), 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 some facilities that hold oilseeds, 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 food
that is not exposed to the environment (proposed Sec. 117.7(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 food as well as
activities conducted on RACs. Although we are not adding more examples
to reflect activities conducted on packaged 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 a food, there are some activities that are performed incidental
to packing a food. For example, sorting, culling, and grading RACs
could be an activity
[[Page 58538]]
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, 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 a food. The revised definition of ``packing'' would be included
in the section 415 registration regulations, the section 414
recordkeeping regulations, and the preventive controls rule. Our
previously proposed revisions already included activities traditionally
performed by farms and farm mixed-type facilities for the safe or
effective packing of RACs (78 FR 3646 at 3681-3682). In this document,
we are proposing to revise the definition of packing in all three
regulations to:
Clarify that packing 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));
Provide that activities performed incidental to packing a food
would apply to all establishments that pack food, not just to farms and
farm mixed-type facilities; and
Delete the provision, in the 2013 proposed preventive controls
rule, that packing would include activities (which may include
packaging) traditionally performed on a farm on RACs grown on a farm
for storage or transport, because this issue would be addressed in the
revised ``farm'' definition.
See the revised regulatory text for the definition of packing in
proposed Sec. Sec. 1.227, 1.328, and 117.3.
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
Some comments object to one or more of the 2013 organizing
principles. As previously discussed, some comments focused on the
distinction (in the ``farm'' definition, and reflected in Organizing
Principle No. 4) that conducting packing and holding activities on a
farm's own RACs would be within the ``farm'' definition, but conducting
packing and holding activities on others' RACs would be outside the
``farm'' definition (see section V.B.1). Other comments focused on
Organizing Principle No. 3--i.e., that 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 (see section V.C.1). One comment asserts that the 2013 organizing
principles rest on a flawed understanding of how farming works because
they assume that farms exist simply to grow crops and that getting
those crops to market is something that ``farms'' don't do. This
comment also asserts that the reality is that a farm cannot stay in
business without marketing its crops and preparing those crops for
market, and that the imperative to maximize the value a farm receives
for its crops creates the need for value-added marketing and
cooperative distribution. This comment recommends that we revise the
organizing principles to reflect the realities and range of activities
that farms do to their crops to prepare those crops and get them to
markets.
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 would change that
framework and, as a consequence, require that we reconsider those
organizing principles.
Organizing Principles Nos. 1, 3 and 5 remain fully 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.
Taking into account the comments we have reviewed so far, 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 preventive controls rule
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 preventive controls rule) that
[[Page 58539]]
could be classified in more than one way. For example, in the 2013
proposed preventive controls rule, we classified ``washing'' as a
harvesting activity (e.g., if RACs are washed while they are being
removed from the field) as well as a manufacturing/processing activity
(e.g., during the production of fresh-cut produce). In this
supplemental notice of proposed rulemaking, we also consider
``washing'' to be a packing activity (e.g., if RACs are washed in a
flume or dump tank located at the farm's packing shed). (Because the
definition of manufacturing/processing specifies that for farms and
farm mixed-type facilities, manufacturing/processing does not include
activities that are part of harvesting, packing, or holding, including
``washing'' as an example of a manufacturing/processing activity would
not mean that a farm is conducting a manufacturing/processing activity
when it washes RACs in its packing shed on its farm, because washing
RACs on a farm would be a packing activity.)
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 a 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., field coring) that we did not
address in the 2013 proposed preventive controls rule. As discussed in
section V.C, we are including this activity to make clear that on farm
``field coring'' of produce (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.
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 preventive controls rule. In the 2013 proposed preventive
controls rule, 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.
Table 5 includes one activity (i.e., fermenting cocoa beans and
coffee beans) that we would now classify differently than we did in the
draft risk assessment (issued in conjunction with the 2013 proposed
preventive controls rule). In the draft risk assessment (Ref. 16), we
classified fermenting cocoa beans and coffee beans as harvesting
activities (see Footnote 2 in Table 23 of the draft risk assessment).
After reconsidering all of the activity classifications, we tentatively
conclude that fermenting cocoa beans and coffee beans should be
classified as ``holding'' rather than as ``harvesting,'' because
fermentation generally happens after cocoa beans and coffee beans are
removed from the plants. We request comment on this reclassification of
fermenting cocoa beans and coffee beans.
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-
Classified in 2013 Classified in supplemental classification represent
Activity proposed preventive notice of proposed a change from the 2013
controls rule rulemaking proposed preventive
controls rule? \2\
----------------------------------------------------------------------------------------------------------------
Cooling........................... Harvesting; (Sec. Harvesting (e.g., Acknowledge that cooling
117.3); Mfg \1\/ hydro-cooling leafy can occur during many
Processing (Sec. vegetables in the field). farm operations.
117.3). Packing (e.g.,
hydro-cooling in a
packing shed).
Holding (e.g.,
cold storage).
Mfg/processing
(e.g., refrigeration of
processed food).
Drying/dehydrating (incidental to Packing or Holding Holding (e.g., Because we would no
holding). (Tables 4 and 5). drying hay or alfalfa). longer consider drying/
dehydrating to be a
packing activity.
Drying/dehydrating to create a Mfg/Processing Mfg/processing Because we are including
distinct commodity (transforms a (Tables 4 and 5). (e.g., drying grapes to this specific mfg/
RAC into a processed food). create raisins, and processing activity
drying herbs to create a within the ``farm''
distinct commodity) definition, provided
(because it transforms a that there is no
RAC into a processed additional manufacturing/
food) (but allowed within processing.
the farm definition).
Fermenting cocoa beans and coffee Harvesting (Footnote Holding.......... Because fermentation
beans. 2 in Table 23 of the generally happens after
draft Risk cocoa beans and coffee
Assessment (Ref. beans are removed from
16)). the plants.
Field coring...................... N/A \3\.............. Harvesting (e.g., Because FDA is addressing
coring lettuce in the the activity for the
field). first time.
Filtering......................... Harvesting (Sec. Harvesting (e.g., Acknowledge that
117.3). filtering honey). filtering can occur
Packing (e.g., during more than
before packing honey). harvesting operations.
Removing stems and husks.......... Harvesting (Sec. Harvesting (e.g., Acknowledge that removing
117.3). in the field). stems/husks can occur
Packing (e.g., in during more than
a packing shed). harvesting operations.
Sifting........................... Harvesting (Sec. Harvesting (e.g., Acknowledge that sifting
117.3). in the field). can occur during more
Packing (e.g., in than harvesting
a packing shed). operations.
[[Page 58540]]
Using pesticides in wash water.... Harvesting (Table 5). Harvesting (e.g., Acknowledge that using
in the field). pesticides in wash water
Packing (e.g., in can occur during more
a packing shed). than harvesting
operations.
Washing........................... Harvesting (Sec. Harvesting (e.g., Acknowledge that washing
117.3), and Mfg/ in the field). can occur during packing
Processing (Sec. Packing (e.g., in operations.
117.3). a dump tank or flume in
the farm's packing shed).
Mfg/processing
(e.g., during production
of fresh-cut produce)
----------------------------------------------------------------------------------------------------------------
\1\ Mfg = Manufacturing
\2\ This table focuses on any change in classification in this document compared to the classification, in the
2013 proposed preventive controls rule, 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.
\3\ N/A = Not applicable.
VIII. Proposed Exemptions for On-Farm Low-Risk Activity/Food
Combinations
A. The 2013 Proposed Exemptions
In the 2013 proposed preventive controls 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 3646 at 3674 and 3689-3691);
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
on- activities that we determine to be low risk involving specific
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. 16 and 78 FR 3824) and proposed three
exemptions for on-farm activity/food combinations conducted by farm-
mixed-type facilities that are small or very small businesses (proposed
Sec. Sec. 117.5(g), (h)(1), and (h)(2)).
B. Comments on the 2013 Proposed Exemptions for On-Farm Low-Risk
Activity/Food Combinations
Some comments 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/food combination listed in the proposed exemptions for on-farm
low-risk activity/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/food
combinations''; and ``if the only manufacturing/processing activities .
. . that the business conducts are the following'').
We have not yet completed either our review of comments asking us
to include additional activity/food combinations in the proposed
exemptions or our analysis of whether each of the recommended additions
would satisfy the criteria, described in the draft risk assessment, for
a low-risk activity/food combination. However, based on our experience
with the draft risk assessment, and the similarity of some of the
recommended activity/food combinations to activity/food combinations we
evaluated in the draft risk assessment, we consider it likely that we
will, after fully considering comments, include additional activity/
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/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
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 to on-farm
packing and holding of processed foods (e.g., packing and holding of
hard candy, fudge, taffy and toffee when conducted by a farm mixed-type
facility).
Second, the proposed exemption for on-farm low-risk manufacturing/
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 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,
mixing different lots of the same RACs (e.g., cocoa beans, coffee
beans, intact fruits and vegetables, grain, honey, maple sap, and
peanuts and tree nuts) would remain within the ``farm'' definition, and
not be considered manufacturing/processing, regardless of whether the
RACs being mixed are the farm's own RACs or others' RACs.
[[Page 58541]]
However, mixing grain products and maple syrup (which are processed
foods rather than RACs) 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/food combinations.
IX. Overall Framework for Hazard Analysis and Risk-Based Preventive
Controls
A. 2013 Overall Framework for Hazard Analysis and Risk-Based Preventive
Controls
In general, in the 2013 proposed preventive controls rule 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 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
preventive controls rule. Some comments express concern that using the
phrase ``reasonably likely to occur'' in two different contexts (i.e.,
within our HACCP regulations as well as in our proposed preventive
controls regulations) would be confusing. Some comments assert that the
``reasonably likely to occur'' approach was already so closely linked
to our HACCP regulations that the 2013 proposed preventive controls
rule 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 and 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. Some comments
suggest that the framework be clearer that the requirements for
preventive controls apply to hazards that are of such a nature that
control measures to significantly minimize or prevent them are
necessary for the production of a safe food and therefore must be
addressed in the food safety plan.
Other comments on the overall framework for hazard analysis and
risk-based preventive controls express concern that the regulatory
text, as proposed, would limit a facility's flexibility to develop and
implement a food safety system that was indeed risk-based. For example,
some comments assert that regulatory text such as ``[p]reventive
controls must include, as appropriate to the facility and the food''
appears to provide flexibility, but the practical effect of the term
``must'' preceding the phrase ``include, as appropriate to the facility
and the food'' is to remove any flexibility as to what preventive
controls must be established and implemented. As another example, these
comments emphasize that the proposed requirements did not sufficiently
emphasize the risk-based nature of each component of the overall
framework for hazard analysis and preventive controls, including
monitoring, corrective action procedures, and verification activities,
in addition to the hazard analysis and preventive controls. In general,
these comments recommend that we provide greater flexibility to manage
the control of hazards based on an assessment of both the severity of
the hazard and the probability that the hazard will occur in the
absence of preventive controls and that we recognize the role of
prerequisite programs in the management of hazards. (One definition of
``prerequisite program'' is the ``procedures, including good
manufacturing practices, that address operational conditions providing
the foundation for the HACCP system'' (Ref. 17).)
C. Proposed Revisions to the Overall Framework for Hazard Analysis and
Risk-Based Preventive Controls
The 2013 proposed preventive controls rule 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 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 preventive controls rule 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.
[[Page 58542]]
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. 117.135(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 preventive controls rule 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 food would, based on the outcome of a hazard analysis,
establish controls to significantly minimize or prevent the hazard in a
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 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 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 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 be 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 a food as well as
components to manage those controls (such as monitoring, corrections or
corrective actions, verification, and records) as appropriate to the
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 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 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. 117.3). 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. 117.330, 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 be required to
have a CCP.
Controls other than those at CCPs...... Preventive maintenance that
inspects and changes chopper
blades on a regular intervals
may be considered a preventive
control in some instances but
would not be required to have
a CCP.
[[Page 58543]]
Circumstances that do not require Preventive controls for
process controls. allergen cross-contact.
Circumstances that do not require Supplier controls.
process controls.
Monitoring activity that generally Monitoring for foreign material
would not require monitoring records. with x-rays.
Corrections that generally would not Re-cleaning and sanitizing
require records. inadequately cleaned food
contact surfaces before start
up.
Preventive controls that would not Zoning controls.
require validation.
Preventive controls that would not Segregation of allergens during
require validation. 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.
------------------------------------------------------------------------
X. 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 preventive controls rule, 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
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 3646 at 3812-3820; see also the
corrected Appendix, 78 FR 17142 at 17143 to 17151).
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. Some comments assert that product testing is required
by section 418 of the FD&C Act and that it is an appropriate means of
verifying overall control, especially for products that support
pathogen growth. In the following paragraphs, we describe some of the
key recommendations in the comments regarding what should be tested,
how testing could be tied to risk, and how product testing could be
used in a food safety plan.
Some comments recommend that product testing include testing raw
materials and ingredients, as well as in-line testing of product during
production. Some comments recommend that requirements encompassing more
than ``finished product testing'' would provide facilities with the
flexibility to establish a risk-based testing program. For example, a
facility that adds seasoning to chips after the chips have been cooked
using a process that would significantly minimize pathogens may
conclude that testing the seasoning used as an ingredient would be a
more appropriate verification activity than testing finished product
(i.e., the chips with the added seasoning). These comments also assert
that requirements for ``product testing'' would be more consistent with
the statutory direction in section 418 of the FD&C Act than
requirements for ``finished product testing.''
Some comments that emphasize the risk-based nature of any
requirements for product testing assert that product testing may be of
limited value for a product that will undergo a ``kill step'' (a
treatment to significantly minimize pathogens) later in processing or
that does not support the survival or growth of environmental pathogens
(because such organisms are unlikely to pose a risk in the finished
food). Other comments note that product testing would not be
appropriate for certain types of facilities, such as distributors. Some
comments question whether product testing would be appropriate for
products with a short shelf life (such as produce).
Some comments identify circumstances where product testing would--
or would not--be appropriate to include as a verification activity in a
food safety plan. For example, comments state that product testing
would be an appropriate verification activity to include in a food
safety plan in plants that produce high-risk products; when there is a
risk of contamination of the product or product contact surfaces; when
the outcome of a hazard analysis demonstrates that a hazard can remain
or be placed on ready-to-eat (RTE) products; when an environmental
pathogen is considered a hazard reasonably likely to occur; when a
positive result is obtained as a result of environmental monitoring;
after a corrective action has been implemented (such as after a product
has been reworked because it tested positive for a pathogen); and in
circumstances where testing is the only practical way to verify the
absence of a contaminant (such as aflatoxin). Some comments state that
product testing would not be an appropriate verification activity to
include in a food safety plan if a positive result from environmental
monitoring is found on a non-product-contact surface.
Some comments recommend written procedures for product testing.
Some of these comments emphasize that any requirements for such written
procedures should not be prescriptive.
Some comments question whether it would be appropriate to require
product testing in light of known limitations such as those discussed
in section I.F of the Appendix. For example, it is generally recognized
that testing cannot
[[Page 58544]]
ensure the absence of a hazard, particularly when the hazard is present
at very low levels and is not uniformly distributed. Moreover, these
comments point out that the number of samples used for routine testing
often is statistically inadequate to provide confidence in the safety
of an individual lot in the absence of additional information about
adherence to validated control measures (78 FR 3646 at 3819). Some
commenters with varying views on the issue nonetheless asked FDA to
issue proposed regulatory text for product testing for consideration.
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 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 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 food, and the
nature of the preventive control (proposed Sec. 117.165(a)(2));
Written procedures for product testing (proposed Sec.
117.165(b)(2));
Corrective action procedures for product testing (proposed Sec.
117.150(a)(1)(ii)(A)); and
Records of product testing (proposed Sec. 117.155(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, the 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 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 preventive controls rule (78 FR 3646 at 3763-3764), the
corrected Appendix (78 FR 17142 at 17143 to 17151), and Ref. 18.
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 RTE product 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 food when it is
exposed. 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 express concern about how
potentially prescriptive requirements would impact products (such as
produce) with a short shelf life.
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 otherwise 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. 19) does not specifically recommend environmental
monitoring as a verification activity in HACCP systems, the Codex
General Principles of Food Hygiene (Ref. 20) 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. Environmental monitoring is
recommended in Codex Guidelines on the Application of General
Principles of Food Hygiene to the Control of Listeria monocytogenes in
Foods (see Annex I) (Ref. 21) and the Code of Hygienic Practice for
Powdered Formulae for Infants and Young Children (see Annex III) (Ref.
22). Moreover, 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 preventive controls rule (78 FR 3646 at 3764-
3765), the corrected Appendix (78 FR 17142 at 17143 to 17151), and
(Ref. 23). Environmental monitoring programs, when implemented
appropriately based on the facility, the 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 facilities to tailor their environmental monitoring
programs based on risk. Environmental monitoring would be required in
the specific circumstances where RTE product is exposed to the
environment prior to packaging and the packaged
[[Page 58545]]
food does not receive a treatment that would significantly minimize an
environmental pathogen that could contaminate the 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 facility conduct environmental
monitoring as appropriate to the facility, the 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 food for safety, and, as
necessary, prevent affected 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 included in a final rule, establish
requirements for:
Performing, as part of the hazard evaluation, an evaluation of
environmental pathogens whenever an RTE 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. 117.130(c)(1)(ii));
Environmental monitoring, for an environmental pathogen (e.g., L.
monocytogenes) or for an appropriate indicator organism (e.g., Listeria
spp.), 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 RTE food with an
environmental pathogen is a significant hazard (proposed Sec.
117.165(a)(3));
Records of environmental monitoring (proposed Sec. 117.155(b));
Written procedures for environmental monitoring (proposed Sec.
117.165(b)(3)); and
Corrective action procedures for environmental monitoring (proposed
Sec. 117.150(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
preventive controls rule (78 FR 3646 at 3764-3765), the corrected
Appendix (78 FR 17142 at 17143 to 17151), and Ref. 23.
XI. 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 preventive controls rule, 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 3646 at 3763-3767). 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 3646 at 3820-3821; see also the corrected Appendix, 78 FR
17142 at 17151 to 17152).
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
[[Page 58546]]
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.
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. 117.201 in the 2013 proposed preventive controls rule).
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 we have 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 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. 117.136 and the
applicable definitions in proposed Sec. 117.3) 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. 117.3)
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. 117.136(a)(1) and
(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. 117.136(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. 117.136(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 or
misbranded under section 403(w) of the FD&C Act, and the incoming raw
material or ingredient is
[[Page 58547]]
produced in compliance with the requirements of applicable FDA food
safety regulations (proposed Sec. 117.136(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 (proposed Sec. Sec. 117.136(b) and 117.136(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, 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.
117.136(c)(2));
Provide for an alternative verification activity when the supplier
is a qualified facility (proposed Sec. 117.136(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.
117.136(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 function (proposed Sec.
117.136(d)(1)) and proposed Sec. 117.180);
Provide that inspection by FDA or an officially recognized or
equivalent food safety authority may substitute for an audit (proposed
Sec. 117.136(e));
Require action to address supplier non-conformance (proposed Sec.
117.136(f)); and
Require documentation of verification activities in records (listed
in proposed Sec. 117.136(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. 117.136(g)(5),
(6), and (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. 117.126(b)(3), 117.135(c)(4), 117.140(b), 117.160(b)(3),
117.165(a)(4), and 117.190(a)(4), respectively). For supplementary
information relevant to a supplier program, see the 2013 proposed
preventive controls rule (78 FR 3646 at 3765-3767), the corrected
Appendix (78 FR 17142 at 17151- 17152), and Ref. 24. In the following
paragraphs, we provide additional information about the potential
proposed requirements for a supplier program.
Reflecting the risk-based (including severity as well as
probability) nature of a 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 IX.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 processor of fresh-
cut produce generally would be required to establish a supplier program
for hazards associated with the fresh produce it processes (which would
be controlled by the supplier during growing and harvesting), but a
manufacturer of an acidified food would not be required to establish a
supplier program for peppers that it uses to produce salsa if it will
control any significant hazard for the peppers during manufacture of
the salsa.
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 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 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, 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 salad
manufacturer is receiving cut produce such as celery from a fresh-cut
produce supplier that receives celery from a farm, the salad
manufacturer could conduct verification activities related to the on-
farm controls by reviewing the supplier program of, and verification
activities conducted by, the fresh-cut produce supplier for its
supplier, the farm (in addition to verifying the fresh-cut produce
supplier'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
[[Page 58548]]
supplier verification very challenging under certain circumstances.
However, we believe that supplier verification is very important for
RACs, in particular produce that will be further processed or consumed
without a treatment that will significantly minimize or prevent
pathogens. We request comment on what verification activities would be
appropriate for receiving facilities to conduct 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
fresh-cut processing facility that receives produce from a distributor,
who receives produce 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 produce coming from the farms? We request
comment on whether and how the requirements for 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 (e.g., by Supplier A, a farm), and Point B in the supply
chain is a facility (such as Warehouse B, Distributor B, or Packing
Shed B) that only packs or holds food, but does not manufacture/process
food (and therefore would not be required to have a supplier program)
before passing it on to Point C in the supply chain, which also would
not be required to have a supplier program (e.g., Retail Food
Establishment C or Consumer C). For example, if Packing Shed B
distributes produce it packs after receiving the produce from Farm A
directly to retail facilities (which would not be subject to the
requirements of this preventive controls rule), no supplier controls
would be applied to Farm A. Should verification activities be required
in circumstances in which a RAC such as fresh produce will not be sent
to any facilities that would be required to have preventive controls
before reaching consumers?
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. 117.126(b)(7)). 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 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 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 food, and responsiveness of
the 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. 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.
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
[[Page 58549]]
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 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 the hazard, how the supplier
controls the hazard, and the supplier's performance history. For
example, a facility that receives pickles from a facility subject to
the acidified foods regulations in 21 CFR 114 may conclude that an FDA
inspection for compliance with acidified foods regulations (concluding
that no action is indicated) provides adequate assurance that the
facility is producing pickles in compliance with the requirements of
applicable FDA food safety regulations and that the pickles are 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
modified requirements. 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)?
XII. 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 preventive controls rule, 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
[[Page 58550]]
risk-based preventive controls (78 FR 3646 at 3659). 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. 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 7802). We also
explained our view that the primary purpose of economically motivated
adulteration is to obtain economic gain rather than to impact 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 and note that the U.S. Pharmacopeial
Convention (USP) has a free on-line food fraud database (Ref. 25). (USP
is a scientific nonprofit organization that sets standards for the
identity, strength, quality, and purity of medicines, food ingredients,
and dietary supplements manufactured, distributed and consumed
worldwide.)
C. Potential Requirements To Address Economically Motivated
Adulteration
Taking into account the comments we have reviewed so far, 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. 117.130(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. 26) 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 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 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 both the 2013 proposed preventive controls rule
and the 2013 proposed intentional contamination rule we discussed a
widespread incident of economically motivated adulteration in which
some milk firms in one country added melamine, a nitrogen-rich
industrial by-product, to diluted dairy products to increase the
apparent protein content (78 FR 3646 at 3659 and 78 FR 78014 at 78021,
respectively). This adulteration resulted in significant public health
consequences, with more than 290,000 ill infants and 6 deaths in that
country. 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 a facility's food products when using milk
products from a country where melamine adulteration had occurred and,
based on the outcome of that hazard analysis, determine whether
melamine is a hazard that must be addressed in the food safety plan. As
none of this adulterated milk was exported to the United States and no
US suppliers have been a source of food safety problems due to milk
products adulterated for economic gain, FDA does not expect a facility
to consider the potential for melamine to be a significant hazard when
using domestic milk products, or milk products from other countries
when there is no history of melamine adulteration associated with those
countries.
There are other well-known substances that have been used in
economically motivated adulteration schemes, have potential to cause
public health harm, and would be prudent to consider in the types of
food products that have been the subject of these schemes. For example,
dyes containing the heavy metal lead have been added to ingredients
such as spices to enhance color. Lead can accumulate in the body over
time and can cause health problems, including such as impaired
[[Page 58551]]
cognitive development in children (Ref. 27). Lead chromate is a
chemical with a vibrant yellow color that has been used as an
adulterant in turmeric to change the color of the spice to suggest that
it is of a higher quality (Ref. 28). Lead oxide is a red chemical that
has been used as an adulterant in paprika to change the color of the
spice to suggest that it is of a higher quality; in 1995, an incident
was reported in Hungary in which dozens of people were made ill and
several people died as a result of consuming contaminated paprika (Ref.
29). Sudan I is an orange-red powder that had been added to chili
powder as a coloring agent, but is now banned in many countries because
the International Agency for Research on Cancer has classified it as a
category 3 carcinogen (not classifiable as to its carcinogenicity to
humans) (Ref. 30); in 2005, contamination of an ingredient prepared
using chili powder containing Sudan I led to a massive recall of food
products in the United Kingdom (Ref. 31).
In addition to the food-fraud database mentioned in the comments, a
recent report from the Congressional Research Service provides
additional information on economically motivated adulteration of food
and food ingredients (Ref. 32). A recent report identified 137 unique
incidents in 11 food categories (Ref. 33).
XIII. 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 preventive controls rule, we explained the
provisions of FSMA that establish criteria for a facility to be a
qualified facility, establish an exemption for qualified facilities,
establish modified 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 3646 at 3657). We proposed to establish:
Definitions relevant to these provisions (proposed Sec. 117.3);
An exemption from the requirements for hazard analysis and risk-
based preventive controls for qualified facilities (proposed Sec.
117.5(a));
Modified requirements for qualified facilities (proposed Sec.
117.201); and
Procedural requirements that would govern our withdrawal of an
exemption for a qualified facility (proposed subpart E; the 2013
proposed withdrawal provisions) (see 78 FR 3702-3703, 3768-3771, and
3775-3780).
The 2013 proposed withdrawal provisions would:
Specify the circumstances under which we would withdraw an
exemption for a qualified facility (proposed Sec. 117.251);
Establish procedures for us to issue an order to withdraw the
exemption, including information that would be in the order (proposed
Sec. Sec. 117.254 and 117.257);
Establish procedures whereby a qualified facility may submit a
written appeal of our order to withdraw an exemption (proposed Sec.
117.260 and 117.264);
Establish procedures for appeals, hearings, and decisions on
appeals and hearings (proposed Sec. Sec. 117.267, 117.270, 117.274,
and 117.277); and
Specify the circumstances in which an order to withdraw an
exemption is revoked (proposed Sec. 117.280).
B. Proposed Clarification of What FDA Will Do Before Issuing an Order
and Proposed Mechanism for Re-Instating an Exemption
1. Comments
Some comments generally support the overall framework of the 2013
proposed withdrawal provisions and express the view that withdrawal of
exemption should be both prompt and permanent to protect public health.
Some comments ask us to explain the difference between withdrawal of an
exemption and suspension of registration. One comment asks us to
clarify the effect a suspension has on a qualified facility and
recommends that suspension automatically result in loss of the
exemption. One comment recommends that we withdraw an exemption at the
earliest signs of problems, because doing so would be most protective
of public health and would be consistent with the principle that a
broad interpretation of statutory exemptions is disfavored when they
affect public health and safety. This comment also asserts that section
418 of the FD&C Act provides a very low threshold for initiating a
withdrawal action, makes that withdrawal permanent, and was designed to
operate on a ``one strike, you're out'' principle. This comment asserts
that the exemption section 418 provides to qualified facilities has no
basis in food safety science or sound policy and endangers consumers
and that withdrawal of an exemption would not result in overly harsh
consequences because it would not close the facility. One comment
discusses our authority to suspend the registration of a facility
(section 102 of FSMA). This comment contrasts FSMA's provisions for
withdrawal with those for suspension, noting that FSMA's provisions for
suspension specify a method to lift that suspension (i.e., submission
of a corrective action plan) but FSMA's provisions for withdrawal of an
exemption provide no remedy for an exemption that is withdrawn.
In contrast, other comments express concern that the 2013 proposed
withdrawal provisions fail to establish a fair and clear process for
withdrawing a qualified facility's exempt status and recommend that we
revise the 2013 proposed withdrawal provisions to provide a more
flexible framework that would be both fair and clear. Some of these
comments express concern that withdrawal of an exemption would subject
very small and small facilities to unexpectedly high compliance costs
that could put them out of business. Some comments recommend that we
add a provision allowing a facility to voluntarily withdraw its
exemption. Some comments recommend more safeguards to ensure that the
process to withdraw an exemption is not abused. In general, these
comments recommend the following three principal revisions to the 2013
proposed withdrawal provisions:
Establish a high threshold for withdrawing an exemption, including
an evidentiary standard that would apply to the criteria for
withdrawing an exemption;
Provide for ``due process'' before we take steps to withdraw an
exemption, including an opportunity for a qualified facility to
maintain its exempt status (e.g., by addressing the specified issues of
concern); and
Provide an opportunity for reinstatement of a withdrawn exemption.
In the following paragraphs, we provide more detail about comments
recommending these three principal revisions.
Threshold for withdrawing an exemption. Some comments assert that
the 2013 proposed withdrawal provisions are extremely vague and appear
to give us broad authority to withdraw an exemption from a qualified
facility without adequate evidence of an actual harm or likely severe
problem related to the facility's practices. Some comments assert that
we should narrowly interpret the statutory criteria for withdrawing an
exemption to avoid action that is arbitrary and capricious, and that to
do so we must show necessity and direct linkage between an active
investigation of a foodborne illness outbreak and the qualified
facility. Some of these comments
[[Page 58552]]
recommend that we define and clarify key terms (including ``directly
linked,'' ``necessary,'' ``associated,'' and ``material to the safety
of food''). Some of these comments also recommend that we introduce a
standard (such as ``credible evidence'' or ``credible and substantial
evidence'' that shows direct linkage to a problem at a specific
facility) that would require us to meet an explicit evidentiary
threshold when we find that conduct or conditions exist in a qualified
facility sufficient to warrant withdrawal of an exemption. Some
comments recommend that the final withdrawal provisions explicitly
provide that the credible and substantial evidence would only apply to
an individual facility, and would not apply to a group or class of
facilities.
Due process before withdrawing an exemption. Some comments note
that we have many enforcement tools that we can use in lieu of
withdrawing an exemption, particularly if there is an immediate risk to
public health. These include seeking an injunction (21 U.S.C. 332;
section 302 of the FD&C Act); seizing the food at issue (21 U.S.C.
334(a)-(f); section 304(a)-(f) of the FD&C Act); and administrative
detention of the food (21 U.S.C. 334(h); section 304(h) of the FD&C
Act). Other comments note that we have a history of providing a
facility with opportunities to fix a problem before starting such an
enforcement action (e.g., by issuing a warning letter). These comments
recommend that we provide such opportunities to qualified facilities
before we take steps to withdraw an exemption.
Some comments recommend that the final withdrawal provisions allow
for partial withdrawal of an exemption in which FDA would indicate
specific sections of the rule that the facility must comply with. These
comments assert that small businesses should be able to seek targeted
solutions as needed without falling under all the substantive, costly
provisions of the rule. Some comments recommend that the final
withdrawal provisions establish a three-tiered process--Tier 1: Warning
letter; Tier 2: Temporary conditional withdrawal of an exemption; and
Tier 3: Full withdrawal of an exemption. For example, a warning letter
would identify the material conduct or conditions in question or how
the facility is directly linked to an active investigation of a
foodborne illness outbreak; include information about how the facility
could remedy the situation; and notify the facility that it has 15
calendar days from receipt of the warning letter to respond with a plan
for remedying the problem within a suitable timeframe. These comments
state that if the facility does not adequately address the problem in
its response to the warning letter and subsequent actions to correct
the problem, we would issue a temporary (e.g., six months) conditional
withdrawal, targeted to a particular issue, outlining how the facility
can remedy the problem. These comments further state that if the
facility still fails to correct the problem after receiving the
temporary conditional withdrawal, we would proceed with steps for full
withdrawal of an exemption.
Reinstatement of an exemption that was withdrawn. Some comments
recommend that we provide a process for each of three situations in
which a qualified facility might regain its exemption status:
Before reaching the deadline for compliance specified in the
withdrawal order, if the facility demonstrates that the conduct or
conditions that triggered the withdrawal order have been sufficiently
resolved;
After the compliance deadline passes if, during an informal
hearing, the facility can show that the conduct or conditions that
triggered the withdrawal have been sufficiently resolved; or
Automatically if we determine, after finishing an active
investigation of a foodborne illness outbreak, that the outbreak is not
directly linked to the facility.
2. Specific Proposed Additions and Modifications to the 2013
Proposed Withdrawal Provisions
As discussed more fully in the following paragraphs, taking into
account the comments we have reviewed so far we are proposing to modify
the 2013 proposed withdrawal provisions to:
Include specific regulatory actions that we must take, and other
regulatory actions that we may consider, before we issue an order to
withdraw an exemption (proposed Sec. 117.251(b));
Clarify that an order to withdraw an exemption must be approved by
an FDA District Director before it can be issued (proposed Sec.
117.254(a) and (b)); and
Provide a process for reinstating an exemption that has been
withdrawn (proposed Sec. 117.287).
See the revised regulatory text for proposed Sec. Sec. 117.251(b),
117.254(a) and (b), and 117.287. In this section of this document, we
are reopening the comment period with respect to these specific
proposed provisions.
Both of the proposed circumstances for withdrawal of an exemption
specify significant public health reasons for doing so, related to an
outbreak of foodborne illness, or being necessary to protect the public
health and prevent or mitigate a foodborne illness outbreak based on
conduct or conditions associated with the qualified facility that are
material to the safety of the food manufactured, processed, packed, or
held at such facility (proposed Sec. Sec. 117.251(a) and (b),
respectively). We do not consider it necessary to define terms such as
``directly linked,'' ``necessary,'' ``associated,'' or ``material to
the safety of food,'' or to introduce a standard (such as ``credible
evidence'' or ``credible and substantial evidence'' that shows direct
linkage to a problem on a specific farm or facility) to provide for a
fair process that is neither arbitrary nor capricious.
We may suspend the registration of a facility if we determine that
food manufactured, processed, packed, received, or held by the facility
has a reasonable probability of causing serious adverse health
consequences or death to humans or animals. If we suspend a facility's
registration, no person can import or export food into the U.S. from
such facility, offer to import or export food into the U.S. from such
facility, or otherwise introduce food from such facility into
intrastate or interstate commerce in the U.S. (See section 415(b) of
the FD&C Act (21 U.S.C. 350d(b)). In contrast, we may withdraw an
exemption from a qualified facility in two circumstances: (1) In the
event of an active investigation of a foodborne illness outbreak that
is directly linked to the qualified facility; or (2) if we determine
that it is necessary to protect the public 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 food manufactured, processed, packed, or held at such facility.
(See section 418(l)(3) of the FD&C Act). A facility that loses its
exemption may distribute food if it is in compliance with applicable
requirements.
The statutory criteria for suspension of registration are separate
and distinct from the statutory criteria for withdrawal of an exemption
and must be considered separately. Suspension of a facility's
registration does not change a facility's status as a qualified
facility. If we take steps to suspend a qualified facility's
registration, we may also separately consider whether the circumstances
that may lead us to withdraw the facility's exemption exist and, if so,
may follow the process that would be established in the final
withdrawal provisions for doing so.
As the comments point out, in many circumstances we have provided
facilities with opportunities to fix a
[[Page 58553]]
problem before starting an enforcement action. Indeed, we consider that
issuing an order to withdraw an exemption would be a rare event, in
part because alternative actions may provide a more expeditious
approach to correcting a problem than withdrawing an exemption.
However, taking into account the concerns expressed in the comments we
have reviewed so far, we are proposing to include specific actions that
we must take, and other actions that we may consider, before we issue
an order to withdraw an exemption. (See the revised regulatory text for
proposed Sec. 117.251(b)). Briefly, the proposed regulatory text would
provide that we:
Notify a qualified facility in writing of circumstances that may
lead us to withdraw its exemption, and provide an opportunity for the
facility to respond, before we issue an order to withdraw the
exemption;
May consider alternative regulatory actions before issuing an order
to withdraw an exemption; and
Consider actions taken by the facility to address the circumstances
that may lead us to withdraw its exemption before issuing an order to
withdraw the exemption.
We are not proposing that we always must take steps to withdraw an
exemption at the earliest signs of problems. Not all problems would
satisfy the statutory threshold for withdrawal of the exemption.
Further, we believe it is appropriate to consider each situation on its
individual merits, such as whether there are illnesses, whether there
are significant violations that could have contributed to the problem,
whether the facility has taken corrective actions to address the
problem, and whether the actions taken are likely to prevent a
reoccurrence of the situation. Moreover, FDA has other tools that may
be available to more quickly protect public health, including recall
and administrative detention.
Regarding reinstatement, we tentatively conclude that the absence
of a specific provision in section 418 of the FD&C Act for the re-
instatement of an exemption that is withdrawn does not preclude us from
providing for such a process, by which a facility may regain its status
as a qualified farm. The proposed regulatory text (see proposed Sec.
117.287) would:
Provide that we could reinstate an exemption on our own initiative
or in response to a written request from the facility;
Require that a written request from a facility include such data
and information as are necessary to demonstrate that the facility has
adequately resolved the problems with the conditions or conduct that
are material to the safety of the food manufactured, processed, packed,
or held at the facility, such that continued withdrawal of the
exemption is not necessary to protect public health and prevent or
mitigate a foodborne illness outbreak;
Provide that if we had withdrawn the exemption due, in whole or in
part, to an active investigation of a foodborne illness outbreak that
had been directly linked to the qualified facility and later determine,
after finishing the active investigation, that the outbreak was not
directly linked to the facility, we would either;
Reinstate the exemption (if the only reason for the withdrawal had
been the outbreak investigation); or
Inform the facility of our finding that the outbreak investigation
was not directly linked to the facility, and provide an opportunity for
the facility to request reinstatement (if the exemption was withdrawn,
in part, due to conditions and conduct that are material to the safety
of the food manufactured, processed, packed, or held at the facility).
We are not proposing to provide for partial withdrawal of an
exemption or establish the three-tiered process recommended in the
comments (i.e., Warning letter; Temporary conditional withdrawal of an
exemption; and Full withdrawal of an exemption). Such a process is not
required by section 418 and would deprive FDA of needed flexibility to
address the varying circumstances that might give rise to a possible
withdrawal of the exemption. Further, the revised regulatory text
provides for a qualified facility to receive written notification that
circumstances may lead us to withdraw an exemption, and provides an
opportunity for the facility to respond. FDA will consider this
response and actions taken by the facility in determining whether to
withdraw the exemption. In addition the newly proposed provision for
reinstatement of an exemption provides an opportunity for a facility to
return to its status as a qualified facility.
C. Proposed Revisions to the Content of an Order To Withdraw an
Exemption
In this section of this document, we are reopening the comment
period with respect to proposed Sec. 117.257(d).
Some comments 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. 117.257(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. 117.257(d)
and 117.260(a) and (c).
1. Comments
Some comments 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 preventive controls rule, 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. These 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 these 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
[[Page 58554]]
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 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 we have reviewed so far, 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. 117.257(d) and
117.260(a) and (c).
XIV. 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 food, adjusted for inflation:
Option 1, $250,000; Option 2, $500,000; and Option 3, $1,000,000. The
2013 proposed preventive controls rule contained several provisions
relevant to very small businesses, including exemptions from subpart C
in Sec. 117.5(g) and Sec. 117.5(h) for very small (and small)
facilities engaged only in specific types of on-farm activities
involving low-risk activity/food combinations, the exemption inSec.
117.5(a) and modified requirements in Sec. 117.201 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. 34); see 78 FR
3646 at 3700-3701). In the 2013 proposed preventive controls rule 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
$250,000, $500,000, or $1,000,000 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 food for defining a very small business, including each of the three
proposed options ($250,000, $500,000, and $1,000,000) as well as other
dollar limits that we did not include as proposed options (i.e.,
$2,000,000, $5,000,000 and $10,000,000). Comments assert that very
small facilities will incur a large portion of the costs associated
with implementing the 2013 proposed 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 food sales up to $1,000,000. Some of these comments
express concern that using lower dollar 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 $1,000,000
would establish that the full preventive controls requirements would
apply to the businesses that produce the vast majority of food products
and that modified requirements would apply to smaller businesses that
represent the majority of producers but the minority of the food
supply.
Other comments support defining a very small business as one with
total annual food sales up to $500,000. These comments maintain that
the $500,000 limit would simplify the definition of a qualified
facility, and make it easier for us to enforce than a lower dollar
amount, because facilities would not need to calculate how much of
their sales were to qualified end-users (as they would under section
418(l)(1)(C) of the FD&C Act).
Other comments support defining a very small business as one with
total annual food sales up to $250,000. These comments maintain that
the $250,000 limit would exempt the fewest facilities among the three
proposed options and that this would be in the interest of public
health. Comments assert that higher dollar limits would remove from the
coverage of the 2013 proposed preventive controls rule precisely those
companies whose practices would be most improved by it. Some of these
comments evaluate the $250,000 limit in the context of section 418(l)
of the FD&C Act, which defines a qualified facility as either a very
small business or a business with annual sales of less than $500,000,
provided a majority of its sales are made directly to qualified end-
users. These comments note that the options with a limit higher than
$250,000 would equal or exceed the amount allowed for sales by
qualified facilities to nonqualified end users under section
418(l)(1)(C) of the FD&C Act and assert that statutory structure and
intent of section 418(l) of the FD&C Act make the proposed $250,000
limit the only available option from among the three options we
proposed. The comments also assert that the close producer-customer
relationship was a control for safety when a business is smaller than
$500,000 in sales and primarily sells directly to consumers or locally
to food retailers and restaurants.
Some comments support defining a very small business as one with
total annual food sales up to $2,000,000, $5,000,000 or $10,000,000. In
general, these comments express concern about the costs associated with
implementing the requirements for hazard analysis and risk-based
preventive controls. For example, the comments assert that these costs
would deter small farms with gross annual sales between $250,000 and $5
million from expanding their businesses (e.g., to develop value-added
products), particularly when annual food sales include foods that would
not be not covered by the requirements for hazard analysis and risk-
based preventive controls (such as for animal food, whole produce, and
low-risk activity/food combinations conducted by a small or very small
business co-located on a farm), and the sales would largely be to
qualified end-users. A comment recommending a $10,000,000 limit
expresses concern that the costs associated with implementing the
requirements for hazard analysis and risk-based preventive controls
would be passed on to consumers.
Some comments do not support defining a very small business based
on total annual food sales and recommend an alternative definition
based on the number of employees (e.g., fewer than 20 employees). These
comments assert that defining very small business based on number of
employees would be consistent with the proposed definition of small
business (which is based on number of employees) and with the smallest
establishment size in the Food
[[Page 58555]]
Processing Sector Study. Other comments support using a combination of
criteria for defining a very small business, including gross sales,
number of employees and risk level of the food being prepared.
Some comments support using the volume of food rather than total
annual food sales. Some comments express concern that the dollar sales
would be applied to all food sold, including food for animals, and
recommend that we base the value on food subject to the preventive
controls for human food rule, on produce and processed food, on human
food (excluding animal feed) or on ``high-risk processed foods.''
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 $1,000,000 in total annual sales of human food adjusted for
inflation. This definition would, as recommended by some comments,
simplify a facility's determination of whether it is a qualified
facility because the facility would only need to calculate its total
sales of human food rather than determine how much food was sold to
qualified end-users. 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 reasonable for the sales limit
in the definition of ``very small business'' to be directed to human
food rather than all food, including animal food. The proposed
definition of ``very small business'' in this document is consistent
with the proposed definition of ``very small business'' in the 2013
proposed rule ``Current Good Manufacturing Practice and Hazard Analysis
and Risk-Based Preventive Controls for Food for Animals'' (78 FR 64736,
October 29, 2013), which would define such a business with respect to
sales of animal food rather than all food. We do not expect that this
proposed change would have a significant effect on the number of
facilities that satisfy the definition of ``very small business,''
because most facilities subject to the statutory requirements for
hazard analysis and risk-based preventive controls do not make both
human and animal food. However, some facilities co-located on a farm
that would not satisfy the definition of ``very small business'' if the
limit on the sales of food includes animal food as well as human food
may fall within the revised definition that would include a limit only
on the sales of human food.
We tentatively conclude that it is not necessary for the dollar
limit in the definition of ``very small business'' to be $250,000 or
less to protect public health. In the 2013 proposed preventive controls
rule, 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
food/combinations and on-farm low-risk manufacturing/processing
activity food/combinations (proposed Sec. Sec. 117.5(a), (g), and (h),
respectively) (see 78 FR 3646 at 3702). We noted that as a group,
businesses with less than $1,000,000 in total annual sales of foods
produce less than two percent of all food produced in the United States
when measured by dollar value. We acknowledge that this estimate of all
food produced in the United States is higher than the estimates for
lower dollar limits (one-half of one percent of all food produced in
the United States, or less than one-half of one percent of all food
produced in the United States, for limits of $500,000 or $250,000,
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.
In the proposed rule, we calculated the costs of the rule, and
estimated the percent of food produced in the United States that would
be subject to modified requirements (i.e., produced by qualified
facilities), by determining which facilities would be qualified based
on ``per facility'' sales. We believe our current calculation based on
firm sales rather than facility sales is more consistent with section
418(l)(1)(B). In the updated PRIA (Ref. 26), we compare the numbers and
their market share of qualified and non-qualified facilities under
different definitions for a very small business using (1) the method in
our original PRIA (the number of facilities with less than $1 million
in annual sales) and (2) the number of firms with less than $1 million
in annual sales (in which multiple facilities may be under the
ownership of one firm). As noted in the updated PRIA (Ref. 26), in the
final rule we will calculate the number of qualified facilities based
on sales on a ``per firm'' basis. Calculating sales at the ``per firm''
level, we estimate that, as a group, those businesses that have less
than $1,000,000 in total annual sales of foods produce less than one
percent of the dollar value of food produced in the United States that
would be covered by the rule without any special provisions for such
businesses (Ref. 26), roughly equivalent to the percentage of food
produced by very small businesses when the level for such entities is
set at $250,000 if the ``per facility'' method of calculation is used.
In contrast, higher dollar limits for very small business (such as the
$2,000,000 or $5,000,000 limits recommended in some of the comments)
using the ``per firm'' method would affect more of the food produced in
the United States (approximately one percent and two percent,
respectively, roughly equivalent to the levels of food affected when
the level is set at $500,000 and $1,000,000, respectively, using the
``per facility'' method) (Ref. 26). We tentatively conclude that the
definition of very small business should exempt from the rule only a
small percent of food to minimize the risk of foodborne illness and,
thus, are proposing a very small business definition of $1,000,000,
which would exempt less than one percent of the dollar value of 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 $250,000 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. 34) concluded that there was no consistent pattern
across food categories in terms of which sizes of establishments
contribute most to foodborne illness risk (78 FR 3646 at 3701).
Moreover, the facilities that would be classified as qualified
facilities would be subject to modified requirements (see proposed
[[Page 58556]]
Sec. 117.201). 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 food to be adulterated or
misbranded and against distributing such 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 food sold rather than on dollar
limits associated with sales of 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 preventive controls rule, 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 food manufactured, processed,
packed or held by the facility. The description ``very small''
addresses size of a business, not risk associated with food the
facility manufactures, processes, packs, or holds.
XV. Other New and Revised Proposed Provisions
A. Proposed New Definitions
1. Proposed Definition of ``Pathogen''
In the 2013 proposed rule, we proposed to define ``environmental
pathogen'' to mean a microorganism that is of public health
significance and is capable of surviving and persisting within the
manufacturing, processing, packing, or holding environment. Variations
of the phrase ``microorganism of public health significance'' appear in
several places in the existing CGMP regulations and in the 2013
proposed preventive controls rule. To both simplify the regulations and
use the same term (i.e., ``pathogen'') when we mean a microorganism of
public significance, we are proposing to define the term ``pathogen''
to mean a microorganism that is of public health significance and to
replace variations of the phrase ``microorganism of public health
significance'' with ``pathogen'' throughout the regulations.
2. Proposed Definition of ``You''
In the 2013 proposed preventive controls rule, we requested comment
on whether there is any meaningful difference between the persons
identified in current part 110 (i.e., ``plant management'' and
``operator'') and the ``owner, operator, or agent in charge''
identified in section 418 of the FD&C Act. We also requested comment on
whether it would be appropriate to refer to the ``owner, operator, or
agent in charge'' of a plant, establishment, or facility throughout
proposed part 117 and, if so, whether the requirements would be clear
if we revised the proposed rule to use pronouns (such as ``you'' and
``your'') within proposed part 117.
Comments that responded to this request for comment focused on an
approach that would make the regulations clear. However, the comments
were divided in terms of how to best provide clarity, particularly with
respect to use of pronouns such as ``you'' and ``your.'' Some of these
comments express concern that it would be confusing if the phrase
``owner, operator, or agent in charge'' applied both to plant
management and operators in the CGMP requirements (proposed subpart B,
derived from current part 110) and to the ``owner, operator, or agent
in charge of a facility'' in the requirements for hazard analysis and
risk-based preventive controls (proposed subpart C). Other comments do
not express this concern and note that the use of pronouns would, as we
suggested, make the regulations more clear.
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 C, D, and E by using pronouns,
without creating confusion, if we (1) define the term ``you'' to mean,
for purposes of part 117, the owner, operator, or agent in charge of a
facility and (2) limit use of the term ``you'' to provisions in
proposed subparts C, D, and E. See the revised regulatory text for the
definition of you (in proposed Sec. 117.3) and its use throughout
revised subpart C.
3. Proposed Definition of ``Significant Hazard''
As discussed in section IX.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. 117.3.
4. Proposed Definition of ``Known or Reasonably Foreseeable Hazard''
As discussed in section IX.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. 117.3.
5. Potential Definitions of ``Qualified Auditor,'' ``Receiving
Facility,'' and ``Supplier''
As discussed in section XI.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.
117.3.
B. Proposed Revisions to Definitions
In the 2013 proposed preventive controls rule, we proposed to:
Delete the definition of the term ``shall'' from the existing CGMP
regulations;
Revise the definitions of several other terms in the existing CGMP
regulations;
Retain the definitions of several other terms in the existing CGMP
regulations, with no changes; and
Establish several new definitions.
We received comment on many of these proposed definitions. Taking
into account the comments we have reviewed so far, we are proposing to
revise the definitions for three of these terms.
1. Revised Definition of ``Cross-contact''
We proposed to define the term ``cross-contact'' to mean the
unintentional incorporation of a food
[[Page 58557]]
allergen into a food. Some comments recommend that we define the term
to be ``allergen cross-contact'' rather than ``cross-contact'' to
reduce the potential for confusion with the term ``cross-
contamination.'' We tentatively conclude that the term ``allergen
cross-contact'' may reduce the potential for confusion with the term
``cross-contamination'' and are proposing to establish a definition for
the term ``allergen cross-contact'' rather than the term ``cross-
contact.''
2. Revised Definition of ``Hazard'' and ``Reasonably Foreseeable
Hazard''
Some comments recommend 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.
3. Revised Definition of Environmental Pathogen
We proposed to define the term ``environmental pathogen'' to mean a
microorganism that is of public 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. Some comments
express 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
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 food may be contaminated and may result in foodborne illness if
that food is consumed without treatment 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 food contaminated by the spores of a pathogenic
sporeformer that is in the environment may not result in foodborne
illness. For example, if 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
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 Sec. ) Proposed revision Explanation
----------------------------------------------------------------------------------------------------------------
Throughout part 117................ Substitute the term ``adequate'' for For the purposes of part 117, there
the term ``sufficient''. is no meaningful difference between
``adequate'' and ``sufficient.'' We
proposed to retain the definition
of ``adequate'' that is in the
existing CGMP requirements in
current part 110, 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.
Throughout subparts C, D, and E.... Substitute the defined term ``you'' Improve clarity and readability.
for ``owner, operator, or agent in
charge of a facility''.
117.126(c), 117.170(a)(4), Re-phrase the proposed requirements Improve clarity and readability.
117.170(a)(5), 117.170(d). in active voice.
117.126(d)......................... Specify that the food safety plan is Distinguish the requirements for the
a record that is subject to the contents of the food safety plan
requirements of subpart F within the from implementation records, which
requirements for the food safety continue to be listed in Sec.
plan (Sec. 117.126) rather than 117.190.
together with the requirements for
other records required by the rule
(Sec. 117.190).
117.130(b)(1) and (b)(2)........... Switch the order of paragraphs (b)(1) We tentatively conclude that it is
and (b)(2) compared to the order in more logical to specify what
the 2013 proposed preventive hazards must be considered (i.e.,
controls rule. 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).
117.135............................ Shorten the title from ``Preventive Simplify the presentation of the
controls for hazards that are requirements and conform with the
reasonably likely to occur'' to proposed deletion of the term
``Preventive Controls''. ``hazards that are reasonably
likely to occur''.
[[Page 58558]]
117.135(c)(1)...................... Rearrange the requirements for (1) It is more logical to place these
parameters associated with the requirements with process controls
control of the hazard and (2) the since their parameters and their
maximum or minimum value, or values are associated with process
combination of values, to which any controls.
biological, chemical, or physical
parameter must be controlled to be
associated with process controls
rather than be a standalone
requirement.
117.135(c)(3) and 117.150(c)....... Move requirements for corrections for Improve clarity and readability.
sanitation controls from the
requirements for preventive controls
(proposed Sec. 117.135) to the
requirements for corrective actions
(proposed Sec. 117.150).
117.137............................ Shorten the title from ``Recall plan Simplify the presentation of the
for hazards that are reasonably requirements and conform with the
likely to occur'' to ``Recall plan''. proposed deletion of the term
``hazards that are reasonably
likely to occur''.
117.145, 117.150, 117.155.......... Redesignate the section numbers from Accommodate insertions of new Sec.
the original section numbers in the 117.136 (supplier program) and new
2013 proposed preventive controls Sec. 117.140 (preventive control
rule (proposed Sec. Sec. 117.140, management components).
117.145, and 117.150, respectively).
117.155, 117.160, 117.165, and Move the more extensive verification Improve clarity and readability.
117.170. requirements for validation,
implementation and effectiveness,
and reanalysis from the single
proposed section (proposed Sec.
117.150) to separate sections
(proposed Sec. Sec. 117.160,
117,165, and 117.170, respectively).
117.170(a)(4)...................... Revise the requirements for Simplify the presentation of
reanalysis of the food safety plan requirements and reduce redundancy
after an unanticipated event in in regulatory text for inter-
which a preventive control is not related requirements.
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.
117.170(c)......................... Specify the ``written food safety Use the term ``food safety plan''
plan'' rather than the ``written for consistency throughout subpart
plan.''. C.
117.170(c)......................... Specify ``document the basis for the Improve clarity and readability.
conclusion that no revisions are
needed'' rather than ``document the
basis for the conclusion that no
additional or revised preventive
controls are needed''.
117.170(e)......................... Specify ``You must conduct a Improve clarity by specifying what
reanalysis of the food safety plan the owner, operator, or agent in
when FDA determines it is necessary charge of the facility must do in
to respond to new hazards and certain circumstances rather than
developments in scientific what FDA may require.
understanding'' rather than ``FDA
may require a reanalysis of the food
safety plan to respond to new
hazards and developments in
scientific understanding.''
117.190............................ Change the title from ``Records Accurately reflect the nature of the
required for subpart C'' to listed records after moving
``Implementation records''. recordkeeping requirements for the
food safety plan to Sec. 117.126.
117.190(a)(3)(ii) and (iii)........ Add ``verification of'' in front of Distinguish these requirements for
``monitoring'' and ``corrective records applying to ``verification
actions''. of monitoring'' and ``verification
of corrective actions'' from other
requirements for ``records of
monitoring'' and ``records of
corrective actions''.
----------------------------------------------------------------------------------------------------------------
XVI. Holding Human Food By-Products Intended for Use in Animal Food
Section 116 of FSMA (21 U.S.C. 2206) (Alcohol-Related Facilities)
provides a rule of construction for certain facilities engaged in the
manufacturing, processing, packing, or holding of alcoholic beverages
and other food. Based on our interpretation of section 116, we proposed
that subpart C would not apply with respect to alcoholic beverages at
facilities meeting two specified conditions (proposed Sec. 117.5(i);
78 FR 3646 at 3707 to 3709). We also proposed that subpart C would not
apply with respect to food other than alcoholic beverages at facilities
described in the exemption, provided such food is in prepackaged form
that prevents direct human contact with the food and constitutes not
more than 5 percent of the overall sales of the facility. However, we
did note that in the case of a brewery manufacturing animal feed,
section 418 of the FD&C Act would apply to the spent grain sold as
animal feed once the spent grain is physically separated from the beer.
Some comments ask us to include the production of by-products of
the alcoholic beverage manufacturing process (such as spent grains,
distillers' grains, and grape pomace) within the exemption applicable
to alcoholic beverages. These comments argue that the mere act of
separating and disposing of those by-products by sale or otherwise
should not trigger an
[[Page 58559]]
obligation to meet onerous and expensive food safety regulations.
The byproducts described in these comments appear to be products
that would be used in food for animals rather than in human food. In
response to the 2013 proposed animal food rule, we received many
comments expressing concerns from brewers and distillers about whether
that rule would allow them to continue providing spent grains for
animal food. These spent grains are very commonly used as animal food,
and are a subset of the much broader practice of human food
manufacturers sending their peels, trimmings, and other by-products to
local farmers or animal food manufacturers rather than to landfills.
Elsewhere in this issue of the Federal Register, we are issuing a
supplemental notice of proposed rulemaking to amend the 2013 proposed
animal food rule. Human food processors already complying with human
food safety requirements would not need to implement additional
preventive controls or Current Good Manufacturing Practice regulations
when supplying a by-product (e.g., wet spent grains, fruit or vegetable
peels, liquid whey) for animal food, except for proposed CGMPs to
prevent physical and chemical contamination when holding and
distributing the by-product (e.g., ensuring the by-product it is not
comingled with garbage when being held or distributed). However,
further processing a by-product for use as animal food (e.g., drying,
pelleting, heat-treatment) would require compliance with the Preventive
Controls for Animal Food rule. If any requirement regarding preventing
physical and chemical contamination in human food by-products for use
as animal food is finalized, it will be finalized as part of a final
preventive controls rule for human food.
XVII. 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. 26). 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. 26) which is available
at http://www.regulations.gov (enter Docket No. FDA-2011-N-0920), 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
(Public Law 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 is 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.
XVIII. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(44 U.S.C. 3501-3520). The collections of information in the proposed
rule have been submitted to OMB for review under Section 3507(d) of the
Paperwork Reduction Act of 1995. 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 Human Food Proposed Rule and
Amendments to Proposed Rule
Description: FDA is proposing to amend its proposed regulation for
Current Good Manufacturing Practice In Manufacturing, Packing, Or
Holding Human Food (CGMPs) to add requirements for domestic and foreign
facilities that are required to register under section 415 of 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 and risk-based preventive controls for
human food take into account the possibility of economically motivated
adulteration of 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
[[Page 58560]]
manufactures, processes, packs, or holds food for consumption in the
United States. There are 97,646 such facilities; 74,900 of which are
considered ``qualified'' facilities under a very small business
definition with a $1 million threshold and thus have reduced
requirements in regards to this rule-making.
The information collection estimate for the preventive controls for
human food proposed rule may increase if the potential requirements
(the addition of provisions for product testing, environmental
monitoring, a supplier program, and identifying any potential hazards
caused because of economically motivated adulteration) are finalized.
The information collection burden was previously estimated to be
3,686,897 hours; the revised estimate includes an additional 74,692
hours should the newly proposed provisions be finalized. To see the
calculations for these additional burden hours, see Table 9. For more
information on the original calculation of the information burden
estimate please refer to the proposed rule PRA (See Ref. 194 in Docket
FDA-2011-N-0920).
Information Collection Burden Estimate
Supplemental Notice of Proposed Rulemaking Burden
FDA estimates the burden for this information collection as
follows:
Recordkeeping Burden
Should the potential provisions in this proposed rule be included
in any final rule, we estimate 1,867 facilities subject to subpart C--
Hazard Analysis and Risk-Based Preventive Controls will choose to
include environmental monitoring procedures as a verification activity
under Sec. 117.165(a)(3). These facilities would need to write-up such
procedures; a one-time burden of 16 hours (5.33 hours annualized). We
also estimate that 319 food manufacturers would choose to make use of
product testing as a verification activity under Sec. 117.165(a)(2).
These facilities would create written procedures for such testing. This
is a one-time potential burden of 16 hours (5.33 hours annualized).
These potential burdens are shown in Table 9 rows 1 and 2.
Should the potential supplier program discussed above be finalized
a receiving facility would establish and implement a risk-based
supplier program for those raw materials and ingredients for which the
receiving facility has identified a hazard that needs to be addressed
in the food safety plan; this includes whenever the receiving facility
determines that a hazard that needs to be addressed in the food safety
plan is controlled before receipt of the raw material or ingredient. We
estimate that should this potential provision be included, about 2,417
receiving facilities would incur a one-time burden of 16 hours (5.33
hours annualized) to write up such a program. This potential burden is
shown in Table 9 row 3.
Should product testing, environmental monitoring, and supplier
programs be finalized, records would need to be reviewed and
maintained. We estimate that there are 689 facilities that would review
and keep such records as a result. These records would require on
average about 30 minutes a month to review and file. There are
operating and maintenance costs associated with the creation of these
records in the form of product testing costs ($6,400,000 annually) and
environmental monitoring sampling costs ($7,200,000 annually) and
audits and ingredient testing costs of/for suppliers ($7,000,000 audits
annually + $1,000,000 testing annually). This potential burden is shown
in Table 9 row 4.
Under Sec. 117.130(b)(2)(iii) the supplemental notice of proposed
rulemaking adds a new element to the required hazard analysis to be
performed by each facility. Facilities must now also consider hazards
that may be intentionally introduced for purposes of economic gain. We
estimate that this added requirement will increase the one-time needed
to write up the hazard analysis by 1 to 5 hours (average 3 hours; 1
hour annualized burden over 3 years) depending on facility size and
number of processes for 16,000 facilities. The operating and
maintenance costs associated with conducting the initial hazard
analysis to assess the possibility of EMA are $5,100,000. These
estimates are shown in Table 9 row 5.
We estimate on an annual basis that all 16,000 facilities will
spend 0.1 hours per year updating the EMA section of their hazard
analyses and that this recurring burden has an associated operating and
maintenance cost of $1,300,000. This burden is shown in Table 9 row 6.
Some receiving facilities will have supplying facilities that meet
the definition of ``qualified'' facilities; these facilities are not
required to comply with subpart C of the proposed rule. In addition, in
some cases the supplier may be a farm not subject to the requirements
in part 112 regarding the raw material or ingredient that the receiving
facility receives from the farm. Under proposed Sec. 117.136(c)(3) and
Sec. 117.136(c)(4) these qualified facilities and exempt farms will
need to create written assurances (to be given to their receiving
facility customers) to describe the processes and procedures that the
supplier is following to ensure the safety of the food. We estimate
that there are 14,212 facility suppliers and farms that would need to
create these documents. We estimate that it will take 2 hours annually
to prepare such documentation. This burden is shown in Table 9, row 7.
Table 9--Estimated Potential Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per Total operating
21 CFR Part 117, subpart C recordkeepers records per records recordkeeping Total hours and maintenance
recordkeeper (in hours) costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Potential product testing written procedures 319 1 319 5.33 1,700 ................
(potential Sec. 117.165(a)(2))...........
Potential environmental monitoring written 1,867 1 1,867 5.33 9,951 ................
procedures (potential Sec. 117.165(a)(3))
Potential supplier program written 2,417 1 2,417 5.33 12,883 ................
(potential Sec. 117.136(a)(2))...........
[[Page 58561]]
Sec. 117.136(a)(3); Sec. 117.165(a)(4) 689 12 8,268 0.5 4,134 $21,600,000
verification records.......................
Sec. 117.130(b)(2)(iii) written HA for EMA 16,000 1 16,000 1 16,000 $5,100,000
Sec. 117.130(b)(2)(iii) updating written 16,000 1 16,000 0.1 1,600 $1,300,000
HA for EMA.................................
Sec. 117.136(c)(3); Sec. 117.136(c)(4) 14,212 1 14,212 2 28,424 ................
qualified or exempt suppliers assurances...
-----------------------------------------------------------------------------------------------------------
Total annual burden hours and costs..... ................ ................ ................ ................ 74,692 $28,000,000
--------------------------------------------------------------------------------------------------------------------------------------------------------
Reporting Burden
There is no additional reporting burden under this supplemental
notice of proposed rulemaking.
Third Party Disclosure Burden
There is no additional third party disclosure burden under this
supplemental notice of proposed rulemaking.
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: 202-395-7285,
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 Human Food.''
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 proposed rule 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.
XIX. Analysis of Environmental Impact
FDA has determined under 21 CFR 25.30(j) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment (Ref. 35) (Ref. 36). Therefore, neither
an environmental assessment nor an environmental impact statement is
required.
XX. 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.
XXI. 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.
These references are also available electronically at http://www.regulatons.gov. We have verified the Web site addresses, but we are
not responsible for any subsequent changes to Web sites after this
document publishes in the Federal Register.
1. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
One. February 28, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket No. FDA-2011-N-
0920.
2. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
Two. March 1, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm336329.htm and in Docket No. FDA-2011-N-
0920.
3. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
One. March 11, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339097.htm and in Docket No. FDA-2011-N-
0920.
4. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
Two. March 12, 2013.'' Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339097.htm and in Docket No. FDA-2011-N-
0920.
5. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
One. March 27, 2013. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339096.htm and in Docket No. FDA-2011-N-
0920.
6. FDA, ``Transcript: FSMA Proposed Rules On Produce Safety And
Preventive Controls For Human Food Facilities. Public Meeting, Day
Two. March 28, 2013. Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm339096.htm and in Docket No. FDA-2011-N-
0920.
7. FDA, ``Record of Outreach Sessions on FDA Proposed Rules,'' 2013.
Available in Docket No. FDA-2011-N-0920.
8. Taylor, M., ``Statement From FDA Deputy Commissioner for Foods
and Veterinary Medicine, Michael Taylor, on Key Provisions of the
Proposed FSMA Rules Affecting Farmers,'' December 19, 2013.
Available at http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm379397.htm. Accessed and printed on January 29, 2014.
9. Taylor, M., ``Your Input Is Bringing Change to Food Safety
Rules,'' December 19, 2013. Available at http://blogs.fda.gov/fdavoice/index.php/2013/12/your-input-is-bringing-change-to-food-safety-rules. Accessed and printed on January 29, 2014.
10. FDA, ``Guidance for Industry: Questions and Answers Regarding
Food Facility Registration (Fifth Edition),'' 2012.
11. FDA, ``Guidance for Industry: What You Need to Know About
Registration of Food Facilities; Small Entity Compliance Guide,''
2012.
12. FDA, ``Guidance for Industry: Questions and Answers Regarding
Establishment and Maintenance of Records By Persons Who Manufacture,
Process, Pack, Transport,
[[Page 58562]]
Distribute, Receive, Hold, or Import Food (Edition 5),'' 2012.
13. FDA, ``What You Need to Know About Establishment and Maintenance
of Records,'' 2014.
14. FDA, ``Guidance for Industry: Antimicrobial Food Additives,''
1999.
15. 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 and printed on August 14, 2014.
16. FDA, ``Draft Qualitative Risk Assessment. Risk of Activity/Food
Combinations for Activities (Outside the Farm Definition) Conducted
in a Facility Co-Located on a Farm,'' 2012.
17. National Advisory Committee on Microbiological Criteria for
Foods, ``Hazard Analysis and Critical Control Point Principles and
Application Guidelines,'' Journal of Food Protection, 61:1246-1259,
1998.
18. FDA Memorandum, ``Product Testing,'' 2014.
19. 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.
20. Codex Alimentarius Commission, ``General Principles of Food
Hygiene, CAC/RCP 1-1969 (Rev. 4-2003),'' 2003.
21. Codex Alimentarius Commission, ``Guidelines on the Application
of General Principles of Food Hygiene to the Control of Listeria
monocytogenes in Ready-to-Eat Foods, CAC/GL 61--2007,'' 2007.
22. Codex Alimentarius Commission, ``Code of Hygienic Practice for
Powdered Formulae for Infants and Young Children, CAC/RCP 66-2008,''
2008.
23. FDA Memorandum, ``Environmental Monitoring,'' 2014.
24. FDA Memorandum, ``Supplier Program,'' 2014.
25. 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 and
printed on February 20, 2014.
26. FDA, ``FSMA Supplemental Notice of Proposed Rulemaking for
Current Good Manufacturing Practice and Hazard Analysis and Risk-
Based Preventive Controls for Human Food. Preliminary Regulatory
Impact Analysis,'' 2014.
27. FDA, ``Supporting Document for Recommended Maximum Level for
Lead in Candy Likely to Be Consumed Frequently by Small Children,''
November, 2006.
28. FDA, ``Best Value, Inc., Recalls PRAN Bran[d] Turmeric Powder
Due to Elevated Levels of Lead,'' October 16, 2013. Available at
http://www.fda.gov/safety/recalls/ucm371042.htm. Accessed and
printed on February 25, 2014.
29. LEAD Action News, ``Adulteration of Paprika in Hungary,'' 1995.
Available at http://www.lead.org.au/lanv3n3/lanv3n3-6.html. Accessed
and printed on February 20, 2014.
30. International Agency for Research on Cancer, ``Agents Classified
by the IARC Monographs, Volumes 1-109,'' January 14, 2014. Available
at http://monographs.iarc.fr/ENG/Classification/ClassificationsAlphaOrder.pdf. Accessed and printed on August 13,
2014.
31. U.K. Food Standards Agency, ``Sudan I Timeline,'' February 24,
2005. http://webarchive.nationalarchives.gov.uk/20111206002505/http://www.food.gov.uk/safereating/chemsafe/sudani/sudanitimeline.
Accessed and printed on February 25, 2014.
32. 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 and printed on March 6, 2014.
33. Everstine, K., J. Spink, and S. Kennedy, ``Economically
Motivated Adulteration (EMA) of Food: Common Characteristics of EMA
Incidents,'' Journal of Food Protection, 76:723-735, 2013.
34. 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.
35. FDA Memorandum, ``Re-proposal of select provisions of the
Proposed Rule: Current Good Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive Controls for Human Food,'' 2014.
36. FDA Memorandum, ``Modernization of food current Good
Manufacturing Practices (cGMP) as required by the Food Safety
Modernization Act of 2011,'' 2011.
List of Subjects
21 CFR Part 1
Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 16
Administrative practice and procedure.
21 CFR Part 117
Food packaging, Foods.
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, as proposed to be amended on January
16, 2013 (78 FR 3646), be further amended as follows:
PART 1--GENERAL ENFORCEMENT REGULATIONS
0
1. The authority citation for 21 CFR part 1 continues to read as
follows:
Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C.
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c,
350d, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 362, 371, 374,
381, 382, 387, 387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264.
0
2. Section 1.227 is amended by revising the definitions for ``Farm'',
``Harvesting'', ``Holding'', and ``Packing'' to read as follows:
Sec. 1.227 What definitions apply to this subpart?
* * * * *
Farm means an establishment under one ownership in one general
physical location devoted to the growing and harvesting of crops, the
raising of animals (including seafood), or both. The term ``farm''
includes establishments that, in addition to these activities:
(1) Pack or hold raw agricultural commodities;
(2) Pack or hold processed food, provided that all processed food used
in such activities is either consumed on that farm or another farm
under the same ownership, or is processed food identified in paragraph
(3)(ii)(A) of this definition; and
(3) Manufacture/process food, provided that:
(i) All food used in such activities is consumed on that farm or
another farm under the same ownership; or
(ii) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same ownership consists only of:
(A) Drying/dehydrating raw agricultural commodities to create a
distinct commodity, and packaging and labeling such commodities,
without additional manufacturing/processing; and
(B) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing.
* * * * *
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 Cosmetic Act. Gathering,
field coring, washing, trimming of outer leaves of, removing stems and
husks from, sifting, filtering, threshing, shelling, and
[[Page 58563]]
cooling raw agricultural commodities grown on a farm are examples of
harvesting.
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.
* * * * *
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) of the Federal Food, Drug,
and Cosmetic Act.
* * * * *
0
3. Section 1.328 is amended by revising the definitions for ``Farm'',
``Harvesting'', ``Holding'', and ``Packing'' to read as follows:
Sec. 1.328 What definitions apply to this subpart?
* * * * *
Farm means an establishment under one ownership in one general
physical location devoted to the growing and harvesting of crops, the
raising of animals (including seafood), or both. The term ``farm''
includes establishments that, in addition to these activities:
(1) Pack or hold raw agricultural commodities;
(2) Pack or hold processed food, provided that all processed food
used in such activities is either consumed on that farm or another farm
under the same ownership, or is processed food identified in paragraph
(3)(ii)(A) of this definition; and
(3) Manufacture/process food, provided that:
(i) All food used in such activities is consumed on that farm or
another farm under the same ownership; or
(ii) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same ownership consists only of:
(A) Drying/dehydrating raw agricultural commodities to create a
distinct commodity, and packaging and labeling such commodities,
without additional manufacturing/processing; and
(B) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing.
* * * * *
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 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.
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.
* * * * *
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) of the Federal Food, Drug,
and Cosmetic Act.
* * * * *
PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
0
4. 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
5. Section 16.1 is amended by revising the entry for ``Sec. Sec.
117.251 through 117.284'' in paragraph (b)(2) to read as follows:
Sec. 16.1 Scope.
* * * * *
(b) * * *
(2) * * *
Sec. Sec. 117.251 through 117.287 (part 117, subpart E), relating
to withdrawal of an exemption applicable to a qualified facility.
* * * * *
PART 117--CURRENT GOOD MANUFACTURING PRACTICE AND HAZARD ANALYSIS
AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD
0
6. The authority citation for 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 note, 371,
374; 42 U.S.C. 243, 264, 271.
Subpart A--General Provisions
Sec. 117.3 [Amended]
0
7. Section 117.3 is amended as follows:
0
a. By removing the definitions for ``cross-contact'', ``hazard
reasonably likely to occur'', and ``reasonably foreseeable hazard'';
0
b. By adding definitions for ``allergen-cross contact'', ``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. 117.3 Definitions.
* * * * *
[[Page 58564]]
Allergen cross-contact means the unintentional incorporation of a
food allergen into a food.
* * * * *
Environmental pathogen means a pathogen capable of surviving and
persisting within the manufacturing, processing, packing, or holding
environment such that food may be contaminated and may result in
foodborne illness if that food is consumed without treatment to
significantly minimize 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 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
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) of the Federal Food, Drug,
and Cosmetic Act.
Pathogen means a microorganism of public 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. 117.180(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 food would, based on the outcome of
a hazard analysis, establish controls to significantly minimize or
prevent the hazard in a 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 $1,000,000 in total annual sales of human food,
adjusted for inflation.
* * * * *
You means, for purposes of this part, the owner, operator, or agent
in charge of a facility.
0
8. Amend Sec. 117.5 by revising paragraph (k) to read as follows:
Sec. 117.5 Exemptions.
* * * * *
(k)(1) Except as provided by paragraph (k)(2) of this section,
subpart B of this part does not apply to any of the following:
(i) ``Farms'' (as defined in Sec. 1.227 of this chapter);
(ii) Fishing vessels that are not subject to the registration
requirements of part 1, subpart H of this part in accordance with Sec.
1.226(f);
(iii) The holding or transportation of one or more ``raw
agricultural commodities,'' as defined in section 201(r) of the Federal
Food, Drug, and Cosmetic Act;
(iv) Activities of ``farm mixed-type facilities'' (as defined in
Sec. 1.227) that fall within the definition of ``farm''; or
(v) Hulling, shelling, and drying nuts (without manufacturing/
processing, such as roasting nuts).
(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 or with the applicable requirements for
packing and holding in part 112 of this chapter.
0
9. Revise subpart C to read as follows:
Subpart C--Hazard Analysis and Risk-Based Preventive Controls
Sec.
117.126 Food safety plan.
117.130 Hazard analysis.
117.135 Preventive controls.
117.136 Supplier program.
117.137 Recall plan.
117.140 Preventive control management components.
117.145 Monitoring.
117.150 Corrective actions and corrections.
117.155 Verification.
117.160 Validation.
117.165 Verification of implementation and effectiveness.
117.170 Reanalysis.
117.180 Requirements applicable to a qualified individual and a
qualified auditor.
117.190 Implementation records.
Sec. 117.126 Food safety plan.
(a) Requirement for a food safety plan. (1) You must prepare, or
have prepared, and implement a written food safety plan.
(2) The food safety plan must be prepared, or its preparation
overseen, by one or more qualified individuals.
(b) Contents of a food safety plan. The written food safety plan
must include:
[[Page 58565]]
(1) The written hazard analysis as required by Sec. 117.130(a)(2);
(2) The written preventive controls as required by Sec.
117.135(b);
(3) The written supplier program as required by Sec.
117.136(a)(2);
(4) The written recall plan as required by Sec. 117.137(a); and
(5) The written procedures for monitoring the implementation of the
preventive controls as required by Sec. 117.145(a)(1);
(6) The written corrective action procedures as required by Sec.
117.150(a)(1); and
(7) The written verification procedures as required by Sec.
117.165(b).
(c) Records. The food safety plan required by this section is a
record that is subject to the requirements of subpart F of this part.
Sec. 117.130 Hazard analysis.
(a) Requirement for a hazard analysis. (1) You must identify and
evaluate, based on experience, illness data, scientific reports, and
other information, known or reasonably foreseeable hazards for each
type of food manufactured, processed, packed, or held at your facility
to determine whether there are significant hazards.
(2) The hazard analysis must be written.
(b) Hazard identification. 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 food allergens; and
(iii) Physical hazards; and
(2) Hazards that may be present in the 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) Hazard evaluation. (1)(i) 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.
(ii) The hazard evaluation required by paragraph (c)(1)(i) of this
section must include an evaluation of environmental pathogens whenever
a ready-to-eat food is exposed to the environment prior to packaging
and the packaged food does not receive a treatment that would
significantly minimize the pathogen.
(2) The hazard evaluation must consider the effect of the following
on the safety of the finished food for the intended consumer:
(i) The formulation of the food;
(ii) The condition, function, and design of the facility and
equipment;
(iii) Raw materials and ingredients;
(iv) Transportation practices;
(v) Manufacturing/processing procedures;
(vi) Packaging activities and labeling activities;
(vii) Storage and distribution;
(viii) Intended or reasonably foreseeable use;
(ix) Sanitation, including employee hygiene; and
(x) Any other relevant factors.
Sec. 117.135 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 food manufactured, processed, packed, or
held by your facility will not be adulterated under section 402 of the
Federal Food, Drug, and Cosmetic Act or misbranded under section 403(w)
of the Federal Food, Drug, and Cosmetic Act.
(2) Preventive controls required by paragraph (a)(1) of this
section include, as appropriate to the facility and the 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 food safety.
(b) Preventive controls must be written.
(c) Preventive controls include, as appropriate to the facility and
the food:
(1) Process controls. Process controls include procedures,
practices, and processes to ensure the control of parameters during
operations such as heat processing, acidifying, irradiating, and
refrigerating foods. 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) Food allergen controls. Food allergen controls include
procedures, practices, and processes to control food allergens. Food
allergen controls must include those procedures, practices, and
processes employed for:
(i) Ensuring protection of food from allergen cross-contact,
including during storage and use; and
(ii) Labeling the finished food, including ensuring that the
finished food is not misbranded under section 403(w) of the Federal
Food, Drug, and Cosmetic Act.
(3) Sanitation controls. 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, biological hazards due to
employee handling, and food allergen hazards. Sanitation controls must
include, as appropriate to the facility and the food, procedures,
practices, and processes for the:
(i) Cleanliness of food-contact surfaces, including food-contact
surfaces of utensils and equipment;
(ii) Prevention of allergen cross-contact and cross-contamination
from insanitary objects and from personnel to food, food packaging
material, and other food-contact surfaces and from raw product to
processed product.
(4) Supplier controls. Supplier controls include the supplier
program as required by Sec. 117.136.
(5) Recall plan. Recall plan as required by Sec. 117.137.
(6) Other controls. Preventive controls include any other
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. 117.136 Supplier program.
(a) Supplier program. (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
[[Page 58566]]
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 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 or
misbranded under section 403(w) 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 a
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) Determination and documentation of the appropriate verification
activities. 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 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 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) Supplier verification activities for raw materials and
ingredients. (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 as determined by the
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, 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.
117.3, 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. 117.3; 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 or misbranded under section 403(w) 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 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) Onsite audit. (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) Substitution of inspection by FDA or an officially recognized
or equivalent food safety authority. (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 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.
(2) For inspections conducted by the food safety authority of a
country whose
[[Page 58567]]
food safety system FDA has officially recognized as comparable or
determined to be equivalent, the 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) Supplier non-conformance. 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.
117.150 to ensure that raw materials or ingredients from the supplier
do not cause food that is manufactured or processed by the receiving
facility to be adulterated under section 402 of the Federal Food, Drug,
and Cosmetic Act or misbranded under section 403(w) of the Federal
Food, Drug, and Cosmetic Act.
(g) Records. The receiving facility must document the following in
records and review such records in accordance with Sec. 117.165(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 the 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. 117.3; 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 or
misbranded under section 403(w) 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. 117.137 Recall plan.
For food with a significant hazard:
(a) You must establish a written recall plan for the food.
(b) The written recall plan must include procedures that describe
the steps to be taken, and assign responsibility for taking those
steps, to perform the following actions as appropriate to the facility:
(1) Directly notify the direct consignees of the food being
recalled, including how to return or dispose of the affected food;
(2) Notify the public about any hazard presented by the food when
appropriate to protect public health;
(3) Conduct effectiveness checks to verify that the recall is
carried out; and
(4) Appropriately dispose of recalled food (e.g., through
reprocessing, reworking, diverting to a use that does not present a
safety concern, or destroying the food).
Sec. 117.140 Preventive control management components.
(a) Except as provided by paragraphs (b) and (c) of this section,
the preventive controls required under Sec. 117.135 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. 117.145;
(2) Corrective actions and corrections in accordance with Sec.
117.150; and
(3) Verification in accordance with Sec. 117.155.
(b) The supplier program established in Sec. 117.136 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.
117.150, taking into account the nature of any supplier non-
conformance;
(2) Review of records in accordance with Sec. 117.165(a)(4); and
(3) Reanalysis in accordance with Sec. 117.170.
(c) The recall plan established in Sec. 117.137 is not subject to
the requirements of paragraph (a) of this section.
Sec. 117.145 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) All monitoring of preventive controls in accordance with this
section
[[Page 58568]]
must be documented in records that are subject to verification in
accordance with Sec. 117.155(a)(2) and records review in accordance
with Sec. 117.165(a)(4)(i).
Sec. 117.150 Corrective actions and corrections.
(a) Corrective action procedures. 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
a ready-to-eat product detected as a result of product testing
conducted in accordance with Sec. 117.165(a)(2); and
(B) The presence of an environmental pathogen or appropriate
indicator organism detected through the environmental monitoring
conducted in accordance with Sec. 117.165(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 food is evaluated for safety; and
(iv) All affected food is prevented from entering into commerce, if
you cannot ensure that the affected food is not adulterated under
section 402 of the Federal Food, Drug, and Cosmetic Act or misbranded
under section 403(w) of the Federal Food, Drug, and Cosmetic Act.
(b) Corrective action in the event of an unanticipated food safety
problem. (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. 117.165(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,
reduce the likelihood that the problem will recur, evaluate all
affected food for safety, and, as necessary, prevent affected food from
entering commerce as would be done following a corrective action
procedure under paragraphs (a)(2)(i) through (iv) of this section; and
(ii) When appropriate, reanalyze the food safety plan in accordance
with Sec. 117.170 to determine whether modification of the food safety
plan is required.
(c) Corrections applicable to food allergen controls and sanitation
controls. 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 food allergen controls in Sec. 117.135(c)(2)(i) or
the sanitation controls in Sec. 117.135(c)(3)(i) or (ii) if you take
action, in a timely manner, to correct such conditions and practices.
(d) Documentation. All corrective actions (and, when appropriate,
corrections) taken in accordance with this section must be documented
in records. These records are subject to verification in accordance
with Sec. 117.155(a)(3) and records review in accordance with Sec.
117.165(a)(4)(i).
Sec. 117.155 Verification.
(a) Verification activities. Verification activities must include,
as appropriate to the preventive control:
(1) Validation in accordance with Sec. 117.160.
(2) Verification that monitoring is being conducted as required by
Sec. 117.140 (and in accordance with Sec. 117.145).
(3) Verification that appropriate decisions about corrective
actions are being made as required by Sec. 117.140 (and in accordance
with Sec. 117.150).
(4) Verification of implementation and effectiveness in accordance
with Sec. 117.165; and
(5) Reanalysis in accordance with Sec. 117.170.
(b) Documentation. All verification activities conducted in
accordance with this section must be documented in records.
Sec. 117.160 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. 117.135 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 the
significant hazards; and
(3) Need not address:
(i) The food allergen controls in Sec. 117.135(c)(2);
(ii) The sanitation controls in Sec. 117.135(c)(3);
(iii) The supplier program in Sec. 117.136; and
(iv) The recall plan in Sec. 117.137.
Sec. 117.165 Verification of implementation and effectiveness.
(a) Verification activities. 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 food, and the nature of the preventive
control:
(1) Calibration of process monitoring instruments 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 a ready-to-eat
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 that 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) Records of monitoring and corrective action records within a
week after the records are created.
(ii) Records of calibration, product testing, environmental
monitoring, and supplier verification activities within a reasonable
time after the records are created.
(b) Written procedures. As appropriate to the facility, the food,
and
[[Page 58569]]
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.
117.150(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.
117.150(a)(1).
Sec. 117.170 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 food;
(4) Whenever appropriate after an unanticipated food safety problem
in accordance with Sec. 117.150(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. 117.180 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. 117.126(a)(2));
(2) Validation of the preventive controls (Sec. 117.160(b)(1));
(3) Review of records (Sec. 117.165(a)(4)); and
(4) Reanalysis of the food safety plan (Sec. 117.170(d)).
(b) A qualified auditor must conduct an onsite audit (Sec.
117.136(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. 117.190 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
10. Revise Sec. 117.251 to read as follows:
Sec. 117.251 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. 117.5(a):
(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
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 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
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
11. Revise Sec. 117.254 to read as follows:
[[Page 58570]]
Sec. 117.254 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 Office of Compliance in the Center for Food Safety and
Applied Nutrition), 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
12. Amend Sec. 117.257 by revising paragraph (d) to read as follows:
Sec. 117.257 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. 117.264.
* * * * *
0
13. Amend Sec. 117.260 by revising paragraphs (a) and (c) to read as
follows:
Sec. 117.260 Compliance with, or appeal of, an order to withdraw an
exemption applicable to a qualified facility.
(a) If you receive an order under Sec. 117.254 to withdraw an
exemption applicable to that facility under Sec. 117.5(a), 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. 117.264.
* * * * *
(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
14. Amend Sec. 117.264 by revising paragraphs (a) introductory text
and (a)(1) to read as follows:
Sec. 117.264 Procedure for submitting an appeal.
(a) To appeal an order to withdraw an exemption applicable to a
qualified facility under Sec. 117.5(a), 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 Office of Compliance in the Center for
Food Safety and Applied Nutrition), 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
15. Amend Sec. 117.267 by revising paragraph (a) to read as follows:
Sec. 117.267 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. 117.264 within
10 calendar days of the date of receipt of the order.
* * * * *
0
16. Add Sec. 117.287 to subpart E to read as follows:
Sec. 117.287 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
Office of Compliance in the Center for Food Safety and Applied
Nutrition) determines that a facility has adequately resolved problems
with the conditions and conduct that are material to the safety of the
food manufactured, processed, packed, or held at the facility and that
continued withdrawal of the exemption is not necessary to protect
public 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 Office of
Compliance in the Center for Food Safety and Applied Nutrition) 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 Office of Compliance in the Center for
Food Safety and Applied Nutrition); 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 food manufactured, processed, packed,
or held at your facility, such that continued withdrawal of the
exemption is not necessary to protect public health and prevent or
mitigate a foodborne illness outbreak.
(c) If your exemption was withdrawn under Sec. 117.251(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. 117.5(a),
and FDA will notify you in writing that your exempt status has been
reinstated.
(d) If your exemption was withdrawn under both Sec. 117.251(a)(1)
and (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. 117.5(a) in
accordance with the requirements of paragraph (b) of this section.
0
17. Amend Sec. 117.305 by revising paragraph (b) to read as follows:
Sec. 117.305 General requirements applying to records.
* * * * *
(b) Contain the actual values and observations obtained during
monitoring and, as appropriate, during verification activities;
* * * * *
0
18. Add Sec. 117.330 to subpart F to read as follows:
Sec. 117.330 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 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.
[[Page 58571]]
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 proposed rule 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 of the proposed additional
example of a harvesting activity in the definition of ``harvesting''
in section V.C and 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 preventive controls rule to our
current thinking on the classification of these on-farm activities
as a result of the proposed revisions to the ``farm'' definition. As
can be seen in Table 1, 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 preventive controls rule) that could be classified in
more than one way.
Table 1--Classification of Activities Conducted On-Farms and Farm Mixed-Type Facilities
----------------------------------------------------------------------------------------------------------------
Examples using the proposed
Classification Examples using the 2013 proposed revisions to the ``farm''
``farm'' definition * definition
----------------------------------------------------------------------------------------------------------------
Harvesting: Activities traditionally Cooling RACs. Cooling RACs.
performed by farms for the purpose of Fermenting cocoa beans and Field coring RACs ** (new
removing RACs from growing areas and coffee beans ** (would change to example, not previously
preparing them for use as food. ``holding''). classified).
Harvesting does not include Filtering RACs. Filtering RACs.
activities that change a RAC into Gathering RACs. Gathering RACs.
processed food. Removing stems and husks Removing stems and husks
from RACs. from RACs.
Shelling RACs. Shelling RACs.
Sifting RACs. Sifting RACs.
Threshing RACs. Threshing RACs.
Trimming of outer leaves Trimming outer leaves from
from RACs. RACs.
Using pesticides in wash Using pesticides in wash
water on RACs. water on RACs.
Washing RACs. Washing RACs.
Packing: Placing food in a container Coating RACs with wax/oil/ Coating RACs with wax/oil/
other than packaging the food and resin for the purpose of storage resin for the purpose of storage
activities performed incidental to or transport. or transport.
packing a food (e.g., activities Drying RACs for the Cooling RACs ** (add'l
performed for the safe or effective purpose of storage or transport ** classification) ***.
packing of that food (such as (would change to only be Filtering RACs ** (add'l
sorting, culling and grading)), but classified as ``holding''). classification).
does not include activities that Labeling RACs. Labeling RACs.
transform a RAC into a processed food. Mixing RACs. Mixing RACs.
Packaging a farm's or farm Packaging RACs regardless
mixed-type facility's own RACs ** of ownership ** (expanded to
(would no longer be limited to include others' RACs).
``own RACs''). Putting RACs or individual
Putting RACs or individual unit cartons into non-consumer
unit cartons into non-consumer containers.
containers. Removing stems and husks
Sorting/grading/culling from RACs ** (add'l
RACs. classification).
Stickering RACs. Sifting RACS ** (add'l
classification).
Sorting/culling/grading
RACs.
Stickering RACs.
Using pesticides in wash
water on RACs ** (add'l
classification).
Washing RACs ** (add'l
classification).
Holding: Storage of food and Drying/dehydrating RACs Cooling RACs ** (add'l
activities performed incidental to during storage (incidental to classification).
storage of a food (e.g., activities packing or storing when the drying/ Drying/dehydrating RACs
performed for the safe or effective dehydrating does not create a (incidental to storing when the
storage of that food, and activities distinct commodity) ** (would no drying/dehydrating does not create
performed as a practical necessity longer be incidental to packing, a distinct commodity).
for the distribution of that food would only be incidental to Fermenting cocoa beans and
(such as blending of the same holding). coffee beans (change from previous
commodity and breaking down Fumigating RACs during classification as harvesting).
pallets)). Holding does not include storage. Fumigating RACs during
activities that change a RAC into a Sorting/culling/grading storage to control pests.
processed food. RACs. Sorting/culling/grading
Storing food. RACs.
Storing food.
[[Page 58572]]
Manufacturing/Processing: Making food Artificial ripening. Artificial ripening.
from one or more ingredients, or Baking. Baking.
synthesizing, preparing, treating, Boiling/Evaporating. Boiling/Evaporating.
modifying, or manipulating food, Bottling. Bottling.
including food crops or ingredients. Canning. Canning.
Examples of manufacturing/processing Chopping. Chopping.
activities are cutting, peeling, Coating RACs for purposes Coating RACs for purposes
trimming, washing, waxing, other than storage/transport. other than storage/transport.
eviscerating, rendering, cooking, Cooking. Cooking.
baking, freezing, cooling, Cooling. Cooling.
pasteurizing, homogenizing, mixing, Coring. Coring (except field
formulating, bottling, milling, Cracking. coring) ** (because field coring
grinding, extracting juice, Crushing. would be newly classified as
distilling, labeling, or packaging. Cutting. harvesting).
For farms and farm mixed-type Distilling. Cracking.
facilities, manufacturing/processing Drying/dehydrating RACS to Crushing.
does not include activities that are create a distinct commodity. Cutting.
part of harvesting, packing, or Eviscerating. Distilling.
holding. Extracting. Drying/dehydrating RACs to
Formulating. create a distinct commodity.
Freezing. Eviscerating.
Grinding. Extracting.
Homogenizing. Formulating.
Infusing. Freezing.
Irradiating. Grinding.
Labeling (other than Homogenizing.
RACs). Infusing.
Milling. Irradiating.
Mixing. Labeling (other than
Packaging (other than RACs).
RACs). Milling.
Pasteurizing. Mixing.
Peeling. Packaging (other than
Rendering. RACs).
Roasting. Pasteurizing.
Salting. Peeling.
Slaughtering and post- Rendering.
slaughter operations. Roasting.
Slicing. Salting.
Smoking. Slaughtering and post-
Sorting, culling, grading slaughter operations.
(not incidental to packing or Slicing.
holding). Smoking.
Trimming. Sorting, culling, grading
Washing. (not incidental to packing or
Waxing. holding).
Trimming.
Washing.
Waxing.
----------------------------------------------------------------------------------------------------------------
* Examples were included in Table 4, Table 5, and/or Proposed Sec. Sec. 117.3 and 117.5(g) and (h) in the
2013 Proposed Preventive Controls Rule 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.
*** 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/
Food Combinations for Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on a Farm,'' 2012.
[FR Doc. 2014-22446 Filed 9-19-14; 8:45 am]
BILLING CODE 4164-01-P