[Federal Register Volume 85, Number 200 (Thursday, October 15, 2020)]
[Rules and Regulations]
[Pages 65197-65200]
[FR Doc No: 2020-22760]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0457; Product Identifier 2020-NM-039-AD; Amendment
39-21261; AD 2020-20-05]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule.

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SUMMARY: The FAA is superseding Airworthiness Directive (AD) 2018-25-02
and AD 2019-23-01, which applied to certain Airbus SAS Model A318
series airplanes; Model A319-111, -112, -113, -114, -115, -131, -132,
and -133 airplanes; Model A320-211, -212, -214, -216, -231, -232, -233,
-251N, -252N, and -271N airplanes; and Model A321 series airplanes.
Those ADs require revising the existing maintenance or inspection
program, as applicable, to incorporate new or more restrictive
maintenance requirements and/or airworthiness limitations. This AD
requires revising the existing maintenance or inspection program, as
applicable, to incorporate new or more restrictive airworthiness
limitations; as specified in a European Union Aviation Safety Agency
(EASA) AD, which is incorporated by reference. This AD was prompted by
a determination that new or more restrictive airworthiness limitations
are necessary and models need to be added to the applicability. The FAA
is issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective November 19, 2020.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of November 19,
2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain other publication listed in this AD as of
January 9, 2020 (84 FR 66579, December 5, 2019).

ADDRESSES: For the EASA material identified in this AD that will be
incorporated by reference (IBR), contact the EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this IBR
material on the EASA website at https://ad.easa.europa.eu.
    For the Airbus material that is incorporated by reference, contact
Airbus SAS, Airworthiness Office--EIAS, Rond-Point Emile Dewoitine No:
2, 31700 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5
61 93 44 51; email<EMAIL_ADDRESS>internet http://www.airbus.com.
    You may view this IBR material at the FAA, Airworthiness Products
Section, Operational Safety Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available in the AD docket on the
internet at https://www.regulations.gov by searching for and locating
Docket No. FAA-2020-0457.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0457; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this final rule, any comments received, and other information. The
address for Docket Operations is U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0036R1, dated June 24, 2020
(``EASA AD 2020-0036R1'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for all Airbus SAS Model A318 series airplanes; Model A319-
111, -112, -113, -114, -115, -131, -132, -133, -151N, and -153N
airplanes; Model A320-211, -212, -214, -215, -216, -231, -232, -233, -
251N, -252N, -253N, -271N, -272N, and -273N airplanes; and Model A321
series airplanes. EASA AD 2020-0036R1 revised EASA AD 2020-0036, dated
February 26, 2020 (``EASA AD 2020-0036'') (which the FAA referred to as
the appropriate source of service information for accomplishing the
actions specified in the notice of proposed rulemaking (NPRM)), and
superseded EASA AD 2018-0288 (which corresponds to FAA AD 2019-23-01
(AD 2019-23-01, Amendment 39-19794 (84 FR 66579, December 5, 2019)
(``AD 2019-23-01'')). Model A320-215 airplanes are not certificated by
the FAA and are not included on the U.S. type certificate data sheet;
this AD therefore does not include those airplanes in the
applicability.
    The FAA issued a NPRM to amend 14 CFR part 39 to supersede AD 2019-
23-01, for certain Airbus SAS Model A318 series airplanes; A319-111, -
112, -113, -114, -115, -131, -132, and -133 airplanes; A320-211, -212,
-214, -216, -231, -232, -233, -251N, -252N, and -271N airplanes; and
A321 series airplanes. AD 2019-23-01 required revising the existing
maintenance or inspection program, as applicable, to incorporate new or
more restrictive airworthiness limitations. AD 2019-23-01 required
airworthiness limitations that are newer or more restrictive than those
specified in AD 2018-25-02, Amendment 39-19513 (83 FR 62690, December
6, 2018) (``AD 2018-25-02''). AD 2019-23-01 specified that
accomplishing the revision required by paragraph (i) of AD 2019-23-01
terminated all requirements of AD 2018-25-02. The NPRM published in the
Federal Register on June 1, 2020 (85 FR 33046). The NPRM was prompted
by a determination that new or more restrictive airworthiness
limitations are necessary and models need to be added

to the applicability. The NPRM proposed to require revising the
existing maintenance or inspection program, as applicable, to
incorporate new or more restrictive airworthiness limitations.
    The FAA is issuing this AD to address fatigue cracking, accidental
damage, or corrosion in principal structural elements, which could
result in reduced structural integrity of the airplane. See the MCAI
for additional background information.

Comments

    The FAA gave the public the opportunity to participate in
developing this final rule. The following presents the comments
received on the NPRM and the FAA's response to each comment.

Request To Use Revised EASA AD

    United Airlines (UAL) and American Airlines (AAL) supported the
NPRM and asked that the proposed AD refer to EASA AD 2020-0036R1 for
accomplishing the required actions (EASA AD 2020-0036, dated February
26, 2020, was referred to in the proposed AD). UAL stated that EASA AD
2020-0036R1 will allow operators to use current requirements and
prevent issuing a revised AD to require compliance with the revised
EASA AD. AAL also noted that operators should be allowed to use the
revised EASA AD.
    The FAA agrees with the commenters' requests. EASA AD 2020-0036R1
does not substantively change the requirements of EASA AD 2020-0036.
Instead, EASA AD 2020-0036R1 adds credit for EASA AMOC approval
10071736 to EASA AD 2018-0288, and notes that Issue 02 of the ALS has
been released. The FAA has changed all references in this AD from EASA
AD 2020-0036 to EASA AD 2020-0036R1, added paragraph (l) to this AD to
provide credit for Rev 0, and changed subsequent paragraphs of this AD
accordingly.

Request To Confirm Intent To Allow Use of Later ALS Revisions

    Delta Air Lines (DAL) requested confirmation that the FAA intended
to allow the use of later ALS revisions to comply with the proposed AD.
The commenter noted that previous ADs required an alternative method of
compliance (AMOC) to use a later ALS revision.
    The FAA confirms that it intends to allow the use of applicable
later ALS revisions to comply with the requirements of this AD. This AD
refers to EASA AD 2020-0036R1 as the appropriate source of service
information for accomplishing the required actions. EASA AD 2020-0036R1
includes the Ref. Publications section, which accepts the use of later
approved variations or revisions of the referenced ALS document for
compliance. Therefore, applicable later approved ALS revisions are
acceptable.

Request To Allow AMOC Approval for Alternative Actions or Intervals
After Revision of Maintenance or Inspection Program

    DAL requested that paragraph (k) of the proposed AD be changed to
also allow alternative actions and intervals after the maintenance and
inspection program has been revised, provided that the actions or
intervals are approved as an alternative method of compliance (AMOC) in
accordance with the procedures specified in paragraph (n)(1) of the
proposed AD. Delta provided no reason or justification for the request.
    The FAA acknowledges the commenter's request and provides
clarification that, if applicable, requesting an AMOC is always an
option; therefore, it is not necessary to revise paragraph (k) of this
AD. This AD has not been changed regarding this request.

Conclusion

    The FAA reviewed the relevant data, considered the comments
received, and determined that air safety and the public interest
require adopting this final rule with the change described previously
and minor editorial changes. The FAA has determined that these minor
changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.
    The FAA also determined that these changes will not increase the
economic burden on any operator or increase the scope of this final
rule.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0036R1 describes new or more restrictive airworthiness
limitations for damage tolerance of airplane structures.
    This AD also requires Airbus A318/A319/A320/A321 Airworthiness
Limitations Section (ALS) Part 2-Damage Tolerant Airworthiness
Limitation Items (DT-ALI), Revision 07, dated June 13, 2018, which the
Director of the Federal Register approved for incorporation by
reference as of January 9, 2020 (84 FR 66579, December 5, 2019).
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

Costs of Compliance

    The FAA estimates that this AD affects 1,553 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:
    The FAA estimates the total cost per operator for the retained
actions from AD 2019-23-01 to be $7,650 (90 work-hours x $85 per work-
hour).
    The FAA has determined that revising the existing maintenance or
inspection program takes an average of 90 work-hours per operator,
although the agency recognizes that this number may vary from operator
to operator. In the past, the agency has estimated that this action
takes 1 work-hour per airplane. Since operators incorporate maintenance
or inspection program changes for their affected fleet(s), the FAA has
determined that a per-operator estimate is more accurate than a per-
airplane estimate. The FAA estimates the total cost per operator for
the new proposed actions to be $7,650 (90 work-hours x $85 per work-
hour).

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.

    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by:
0
a. Removing Airworthiness Directive (AD) 2018-25-02, Amendment 39-19513
(83 FR 62690, December 6, 2018), and AD 2019-23-01, Amendment 39-19794
(84 FR 66579, December 5, 2019); and
0
b. Adding the following new AD:

2020-20-05 Airbus SAS: Amendment 39-21261; Docket No. FAA-2020-0457;
Product Identifier 2020-NM-039-AD.

(a) Effective Date

    This AD is effective November 19, 2020.

(b) Affected ADs

    This AD replaces AD 2018-25-02, Amendment 39-19513 (83 FR 62690,
December 6, 2018) (``AD 2018-25-02''), and AD 2019-23-01, Amendment
39-19794 (84 FR 66579, December 5, 2019) (``AD 2019-23-01'').

(c) Applicability

    This AD applies to Airbus SAS airplanes identified in paragraphs
(c)(1) through (4) of this AD, certificated in any category, with an
original certificate of airworthiness or original export certificate
of airworthiness issued on or before October 11, 2019.
    (1) Model A318-111, -112, -121, and -122 airplanes.
    (2) Model A319-111, -112, -113, -114, -115, -131, -132, -133, -
151N, and -153N airplanes.
    (3) Model A320-211, -212, -214, -216, -231, -232, -233, -251N, -
252N, -253N, -271N, -272N, and -273N airplanes.
    (4) Model A321-111, -112, -131, -211, -212, -213, -231, -232, -
251N, -251NX, -252N, -252NX, -253N, -253NX, -271N, -271NX, -272N,
and -272NX airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a determination that new or more
restrictive airworthiness limitations are necessary. The FAA is
issuing this AD to address fatigue cracking, accidental damage, or
corrosion in principal structural elements, which could result in
reduced structural integrity of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Maintenance or Inspection Program Revision, With No
Changes

    This paragraph restates the requirements of paragraph (g) of AD
2019-23-01, with no changes. Accomplishing the maintenance or
inspection program revision required by paragraph (i) of this AD
terminates the requirements of this paragraph.
    (1) For airplanes with an original certificate of airworthiness
or original export certificate of airworthiness issued on or before
June 13, 2018, except for Model A319-151N and -153N airplanes and
Model A320-253N, -272N, and -273N airplanes: Within 90 days after
January 9, 2020 (the effective date of AD 2019-23-01), revise the
existing maintenance or inspection program, as applicable, to
incorporate the information specified in Airbus A318/A319/A320/A321
Airworthiness Limitations Section (ALS) Part 2--Damage Tolerant
Airworthiness Limitation Items (DT-ALI), Revision 07, dated June 13,
2018.
    (2) The initial compliance time for doing the tasks is at the
time specified in Airbus A318/A319/A320/A321 Airworthiness
Limitations Section (ALS) Part 2--Damage Tolerant Airworthiness
Limitation Items (DT-ALI), Revision 07, dated June 13, 2018, or
within 90 days after January 9, 2020, whichever occurs later.

(h) Retained Restriction on Alternative Actions and Intervals With a
New Exception

    This paragraph restates the requirements of paragraph (h) of AD
2019-23-01, with a new exception. Except as required by paragraph
(i) of this AD, after the maintenance or inspection program has been
revised as required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals may be used unless the
actions or intervals are approved as an alternative method of
compliance (AMOC) in accordance with the procedures specified in
paragraph (m)(1) of this AD.

(i) New Maintenance or Inspection Program Revision

    Except as specified in paragraph (j) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2020-0036R1, dated June 24, 2020 (``EASA AD 2020-0036R1'').
Accomplishing the maintenance or inspection program revision
required by this paragraph terminates the requirements of paragraph
(g) of this AD.

(j) Exceptions to EASA AD 2020-0036R1

    (1) The requirements specified in paragraphs (1) and (2) of EASA
AD 2020-0036R1 do not apply to this AD.
    (2) Paragraph (3) of EASA AD 2020-0036R1 specifies revising
``the AMP'' within 12 months after its effective date, but this AD
requires revising the existing maintenance or inspection program, as
applicable, to incorporate the ``tasks and associated thresholds and
intervals'' specified in paragraph (3) of EASA AD 2020-0036R1 within
90 days after the effective date of this AD.
    (3) The initial compliance times for doing the tasks specified
in paragraph (3) of EASA AD 2020-0036R1 are at the applicable
``associated thresholds'' specified in paragraph (3) of EASA AD
2020-0036R1, or within 90 days after the effective date of this AD,
whichever occurs later.
    (4) The provisions specified in paragraphs (4), (5), and (6) of
EASA AD 2020-0036R1 do not apply to this AD.
    (5) The ``Remarks'' section of EASA AD 2020-0036R1 does not
apply to this AD.

(k) New Provisions for Alternative Actions or Intervals

    After the existing maintenance or inspection program has been
revised as required by paragraph (i) of this AD, no alternative
actions (e.g., inspections) or intervals are allowed unless they are
approved as specified in the provisions of the ``Ref. Publications''
section of EASA AD 2020-0036R1.

(l) Credit for Original EASA AD

    This paragraph provides credit for actions required by paragraph
(i) of this AD, if those actions were performed before the effective
date of this AD using EASA AD 2020-0036, dated February 26, 2020.

(m) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (n) of this AD. Information may
be emailed to<EMAIL_ADDRESS>    (i) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (ii) AMOCs approved previously for AD 2019-23-01 are approved as
AMOCs for the corresponding provisions of EASA AD 2020-0036R1 that
are required by paragraph (g) of this AD.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions

from a manufacturer, the instructions must be accomplished using a
method approved by the Manager, Large Aircraft Section,
International Validation Branch, FAA; or EASA; or Airbus SAS's EASA
Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.

(n) Related Information

    For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(o) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (3) The following service information was approved for IBR on
November 19, 2020.
    (i) European Union Aviation Safety Agency (EASA) AD 2020-0036R1,
dated June 24, 2020.
    (ii) [Reserved]
    (4) The following service information was approved for IBR on
January 9, 2020 (84 FR 66579, December 5, 2019).
    (i) Airbus A318/A319/A320/A321 Airworthiness Limitations Section
(ALS) Part 2--Damage Tolerant Airworthiness Limitation Items (DT-
ALI), Revision 07, dated June 13, 2018.
    (ii) [Reserved]
    (5) For information about EASA AD 2020-0036R1, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu.
    (6) For information about the Airbus material that is
incorporated by reference, contact Airbus SAS, Airworthiness
Office--EIAS, Rond-Point Emile Dewoitine No: 2, 31700 Blagnac Cedex,
France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
<EMAIL_ADDRESS>internet http://www.airbus.com.
    (7) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2020-0457.
    (8) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on September 18, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-22760 Filed 10-14-20; 8:45 am]
BILLING CODE 4910-13-P


United States

Environmental Protection

Agency

	Office of Prevention, Pesticides

And Toxic Substances

(7510P)		EPA 712-C-07-056

 	Product Performance Test Guidelines

		OPPTS 810.2100:

Sterilants—Efficacy Data Recommendations

Public Review Draft

NOTICE

          This guideline is one of a series of test guidelines
established by the Office of Prevention, Pesticides and Toxic Substances
(OPPTS), United States Environmental Protection Agency for use in
testing pesticides and chemical substances to develop data for
submission to the Agency under the Toxic Substances Control Act (TSCA)
(15 U.S.C. 2601, et seq.), the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.), and section 408 of the
Federal Food, Drug, and Cosmetic (FFDCA) (21 U.S.C. 346a).

	The OPPTS test guidelines serve as a compendium of accepted scientific
methodologies and protocols that are intended to provide data to inform
regulatory decisions under TSCA, FIFRA, and/or FFDCA.  This document
provides guidance for conducting the test, and is also used by EPA, the
public, and the companies that are subject to data submission
requirements under TSCA, FIFRA and/or the FFDCA.  As a guidance
document, these guidelines are not binding on either EPA or any outside
parties, and the EPA may depart from the guidelines where circumstances
warrant and without prior notice.  The procedures contained in this
guideline are strongly recommended for generating the data that are the
subject of the guideline, but EPA recognizes that departures may be
appropriate in specific situations. You may propose alternatives to the
recommendations described in these guidelines, and the Agency will
assess them for appropriateness on a case-by-case basis.

	For additional information about OPPTS harmonized test guidelines and
to access the guidelines electronically, please go to
http://www.epa.gov/oppts and select “Test Methods & Guidelines” on
the left side navigation menu.  You may also access the guidelines in
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov
grouped by Series under Docket ID #s: EPA-HQ-OPPT-2009-0150 through
EPA-HQ-OPPT-2009-0159, and EPA-HQ-OPPT-2009-0576.

DRAFT DOCUMENT DISCLAIMER:  This draft document is distributed solely
for the purpose of external review.  It has not been formally
disseminated by the EPA and should not be construed to represent any
Agency determination or policy.  The information correction process
under the Agency’s Information Quality Guidelines does not apply until
this document is formally disseminated by the EPA in its final form.
This draft document should only be cited or quoted in the context of
providing comments.

OPPTS 810.2100:   Sterilants—efficacy data recommendations.

(a) Scope

(1) Applicability.  This guideline is intended to meet testing
requirements of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) (7U.S.C. 136, et seq.) and the Federal Food, Drug, and Cosmetic
Act (FFDCA) (21 U.S.C. 346a).  It addresses testing to demonstrate
effectiveness of products which are sterilants.

(2) Background.  The source materials used in developing this OPPTS test
guideline are OPP guidelines 91-2: Products for use on hard surfaces and
91-30: Acceptable methods (Pesticide Assessment Guidelines, Subdivision
G, Product Performance.  EPA report 540/9-82-026, October 1982

(b) Purpose.  This guideline addresses efficacy testing for
antimicrobial pesticides intended to be used on hard, inanimate,
environmental surfaces, and, which bear label claims as sterilants.

(c)  General considerations

(1)  This guideline recommends tests to be conducted and data to be
submitted which the Agency believes will generally satisfy the
requirements for pesticide registration.  Studies conducted under this
guideline should be completed under EPA’s Good Laboratory Practice
regulations (40 CFR Part 160).  Note:  The Association of Official
Analytical Chemicals (AOAC) recommended tests are expected to be
conducted as written.  For deviations (e.g., cultures grown with shaking
instead of static, dilution of culture prior to drying on carriers)
proposed to be used in the conduct of these tests, obtain written
approval from the Agency and document such deviations in the study
reports submitted to the Agency.  The Agency may consult with the AOAC
prior to accepting modifications to their standardized methods.  Refer
to OPPTS Test Guideline 810.2000 for general testing recommendations
prior to initiating tests.

(2)  Validation testing approaches, which may be needed to augment the
full range of efficacy tests in special circumstances, are also
described.

(d)  Water-soluble powders and non-volatile liquid products

(1)  Test procedure.  The Agency recommends use of the Official Methods
of Analysis of AOAC International, Official Method 966.04 Sporicidal
Activity of Disinfectants test, Method II (Ref. 1) to demonstrate the
sterilant efficacy of products. Sixty carriers representing each of two
types of surfaces (porcelain penicylinders and silk suture loops) should
be tested against spores of both Bacillus subtilis (B. subtilis)
(American Type Culture Collection (ATCC) 19659) and Clostridium
sporogenes (C. sporogenes) (ATCC 3584) on three samples representing
three different batches of the product, one of which should be at least
60 days old (240 carriers per sample, or a total of 720 carriers).  The
inoculum employed should provide a count of 1 x 105 – 1 x 106 colony
forming units per carrier.   Any sterilant which is a vapor or gas and
is recommended for use in a specific device should be tested using the
AOAC International Sporicidal Activity of Disinfectants test in that
specific device and according to the directions for use of that specific
device.  Modifications to the AOAC Sporicidal Activity of Disinfectants
test to address this use should be submitted to the Agency for review
and approval prior to conducting the tests.

(2)  Evaluation of sterilant success.  The product should kill the test
spores on all of the 720 carriers without any failures.

(e)  Validation testing for all products with sterilant claims.  Data
submitted to support sterilant claims are subject to independent
validation testing in a second laboratory.

(1) Test procedure. The Agency recommends use of the Official Methods of
Analysis of AOAC International, Official Method 966.04 Sporicidal
Activity of Disinfectants test, Method II (Ref. 1) to demonstrate the
sterilant efficacy of products.  Thirty carriers representing each of
the two types of surfaces (porcelain penicylinders and silk suture
loops), should be tested against the spores of both B. subtilis and C.
sporogenes on one sample of the product.  The inoculum employed should
provide a count of 1 x 105 – 1 x 106 colony forming units per carrier.

(2)  Evaluation of sterilant success.  The product should kill the test
spores on all 120 carriers without any failures.

(f)  Sprays, gases, and foams.  (Reserved.)

(g) Additional spore formers, Clostridium difficile (C. difficile)
claims.  This section addresses interim efficacy tests for products with
claims to inactivate C. difficile spores on hard, non-porous, inanimate
surfaces.  The Agency recommends three possible options, as described in
paragraphs (g)(1)(i) through (g)(1)(iii) of this guideline.

(1)  Water-soluble powders and liquid products, qualitative
testing—(i) Test procedure for sterilant/sporicide plus C. difficile
claim.  The Agency recommends use of the Official Methods of Analysis of
AOAC International, Official Method 966.04 Sporicidal Activity of
Disinfectants test, Method II (Ref. 1) to demonstrate the sterilant
efficacy of products, as described in (d)(1).  In addition, conduct a
confirmatory test using the Official Methods of Analysis of AOAC
International, Official Method 966.04 Sporicidal Activity of
Disinfectants test, Method I.  Until the Agency identifies a
representative toxigenic strain or suitable surrogate(s) to be used in
testing against C. difficile, one of the following toxigenic strains
should be used for testing:  ATCC 700792, ATCC 43598 or ATCC 43599.  C.
difficile spores are inoculated on thirty carriers (porcelain
penicylinders) for two samples, representing two different batches of
the product (a total of 60 carriers).

(A) Evaluation of sporicidal success.  The product should kill all of
the test spores on all of the 780 carriers without any failures.

(B) Reserved.

(ii) Test procedure for C. difficile sporicides--qualitative testing.
The Agency recommends use of the Official Methods of Analysis of AOAC
International, Official Method 966.04 Sporicidal Activity of
Disinfectants test, Method I (Ref. 1) using C. difficile ATCC 700792,
ATCC 43598 or ATCC 43599.  Sixty carriers (porcelain penicylinders)
should be tested on three samples representing three different batches
of product, one of which should be at least 60 days old (a total of 180
carriers).  The inoculum employed should provide a target count of 1 x
105 – approximately 1 x 106 colony forming units per carrier.

(A) Evaluation of sporicidal success.  The product should kill all of
the test spores on all of the 180 carriers without any failures.

(B) Reserved.

(iii)  Test procedure for C. difficile sporicides--quantitative testing.
 The Agency recommends the use AOAC Method 2008.05: Quantitative Three
Step Method (Efficacy of Liquid Sporicides Against Spores of Bacillus
subtilis on a Hard Nonporous Surface) (Ref. 2) or ASTM E 2197-02:
Standard Quantitative Carrier Test Method to Evaluate the Bactericidal,
Fungicidal, Mycobactericidal, and Sporicidal Potencies of Liquid
Chemical Germicides (Ref. 3).  Until the Agency identifies a
representative toxigenic strain or suitable surrogate(s) to be used in
testing against C. difficile, one of the following toxigenic strains
should be used for testing:  ATCC 700792, ATCC 43598 or ATCC 43599.  The
inoculum employed should provide a target count of > 106 colony forming
units per carrier. The product should be tested on three samples
representing three different batches of product, one of which should be
at least 60 days old. The number of carriers will vary depending on the
test method.

(A) Evaluation of sporicidal success.  The product should achieve a log
reduction of at least 6 logs based on recoverable spores.

(h)  Sprays, gases, and foams.  (Reserved.)

(i)  Bacillus anthracis (B. anthracis) claims.  This section addresses
efficacy tests for all products with claims to inactivate B. anthracis
spores on inanimate surfaces.  The Agency recommends three possible
approaches, as described in paragraphs (h)(1)(i) through (h)(1)(iii) of
this guideline.

(1)  Water-soluble powders, liquid products, gases and vapors—(i) Test
procedure for sterilant/sporicide plus B. anthracis claim.  The Agency
recommends use of the Official Methods of Analysis of AOAC
International, Official Method 966.04 Sporicidal Activity of
Disinfectants test (Ref. 1) to demonstrate the sterilant efficacy of
products.  Sixty carriers representing each of two types of surfaces
(porcelain penicylinders and silk suture loops) should be tested against
spores of both B. subtilis (ATCC 19659) and C. sporogenes (ATCC 3584) on
three samples representing three different batches of the product, one
of which should be at least 60 days old (240 carriers per sample, or a
total of 720 carriers).  The inoculum employed should provide a target
count of 1 x 105 – approximately 1 x 106 colony forming units per
carrier.  In addition, conduct a confirmatory test using virulent B.
anthracis spores (or a surrogate acceptable to EPA) inoculated on thirty
carriers representing each of two types of surfaces (porcelain
penicylinders and silk suture loops) on two samples, representing two
different batches of the product (a total of 120 carriers).

(A) Evaluation of sporicidal success.  The product should kill all of
the test spores on all of the 840 carriers without any failures.

(B) Reserved.

(ii) Test procedure for sporicidal decontaminants--qualitative testing.
The Agency recommends use of the Official Methods of Analysis of AOAC
International, Official Method 966.04 Sporicidal Activity of
Disinfectants test (Ref. 1) using virulent B. anthracis spores (or a
surrogate acceptable to EPA).   Sixty carriers representing either or
both of two types of surfaces (porcelain penicylinders and/or silk
suture loops) should be tested on three samples representing three
different batches of product, one of which should be at least 60 days
old.  The inoculum employed should provide a target count of 1 x 105 –
approximately 1 x 106 colony forming units per carrier.    If one
surface type is tested, then there are 60 carriers per sample, or a
total of 180 carriers; if both surfaces types are tested, then the total
number of carriers is 360.

(A) Evaluation of sporicidal success.  The product should kill all of
the test spores on all of the 180 (or 360) carriers without any
failures.

(B) Reserved.

(iii)  Test procedure for sporicidal decontaminants--quantitative
testing.  The Agency recommends the use of a well developed,
quantitative sporicidal test method acceptable to EPA using virulent B.
anthracis spores (or a surrogate acceptable to EPA) on porous and/or
nonporous surfaces acceptable to EPA.  The inoculum employed should
provide a target count of approximately 1 X 107 colony forming units per
carrier. The product should be tested on three samples representing
three different batches of product, one of which should be at least 60
days old. The number of carriers will vary depending on the test method.
 The coupon material(s) should be representative of those found at the
site(s) that appear on the product’s labeling, and be acceptable to
EPA.

(A) Evaluation of sporicidal success.  The product should achieve a log
reduction of at least 6 logs based on recoverable spores.

(B) Reserved.

(2) Simulated use testing for gas and vapor products—(i) Test
procedure.  In addition to conducting one of the three laboratory
studies in paragraphs (k)(1)(i) through (h)(1)(iii) of this guideline,
simulated-use testing should also be conducted for vapor and gas
products.  Protocols for the simulated-use test should be submitted to
the Agency for review and approval prior to conducting the test.  The
testing should be conducted under conditions that are representative of
the uses specified on the product’s labeling, and in a setting that is
representative of the label use site(s).   For example, a product
intended for use in a room or a large warehouse should be tested in an
empty room or large chamber.  The purpose of the test would be to assure
that key parameters for efficacy (chemical concentration, temperature,
relative humidity and contact time) are accurately monitored and
maintained throughout the enclosed space, and establish product
generation rate (lbs/hr) and rate/volume (lbs/hr/ft3).

(ii)  Additional considerations.  Important issues to consider in
developing the protocol for this test include:

	(A)  The test should be set up in a sealed enclosure at least the size
of a typical office and designed to measure the distribution of the
product and conditions needed to meet the measure of success in the
laboratory efficacy test.  Items that might be treated (e.g., dressers,
upholstered furniture, carpet, etc,) during an actual fumigation, should
be included in this test.

	(B)  The protocol should specify the dimensions of the enclosure,
number and location of monitoring devices (e.g., for gas or vapor
concentration, total mass of gas or vapor injected into the enclosure,
temperature, relative humidity), product application equipment, heaters
and fans, contact time, etc.  The equipment used to monitor and maintain
these test parameters should be described.

	(C)  All recorded test results pertaining to the test
conditions/parameters should be submitted to the Agency.  The maximum
volume of space that can be treated with a particular unit should be
reported to the Agency.  The minimum total mass of gas or vapor required
to maintain the required concentration and contact time per cubic foot
of space to be decontaminated should be reported.

	(D)  Appropriate positive and negative controls should be employed.

	(E)  This test must be conducted either in accordance with Good
Laboratory Practices (GLP) per 40 CFR Part 160 or in a federal
laboratory with an appropriate Quality Assurance Project Plan (QAPP).

	(iii)  Evaluation of sporicidal success.  Measurements should show that
the same concentration, temperature, and relative humidity, can be
maintained for the required contact time needed to achieve 100% kill
(i.e., no growth on any of the carriers) in the qualitative laboratory
test, or a 6 log reduction in the quantitative test is demonstrated in
the simulated-use test.  In addition, measurements of the fumigant mass
injection/generation rate (e.g., pounds/hour), divided by the volume of
the simulated use test bed, that was used to arrive at the required
generation rate/volume (e.g., pounds per hour/cubic foot) for the
fumigation, should be included with the data, and listed on the product
label.

(j)  Data collection and reporting—(1) General.  To assist in the
proper review and evaluation of product performance, complete
descriptions of the test employed and the results obtained should be
submitted to the Agency.  All test reports should include, at the least,
the material in paragraphs (j)(1)(i) through (j)(1)(xiv) in this
guideline:

(i) Study title;

(ii)  Product Identity;

(iii)  Guideline number;

(iv)  Identification of the testing laboratory or organization;

(v)  Location where the test was performed;

(vi)  Name(s) of the person(s) responsible for the test;

(vii)  40 CFR Part 160 Good Laboratory Practice compliance;

(viii)  Purpose of the study;

(ix)  Date and time of the start and end of the test;

(x)  Statistical treatment of the data;

(xi)  Conclusions;

(xii)  References;

(xiii)  Appendices;

(xiv)  Certification

The applicant is encouraged to use the EPA’s standard efficacy report
format, which may be found at   HYPERLINK
"http://www.epa.gov/oppad001/efficacystudystandards.htm"
http://www.epa.gov/oppad001/efficacystudystandards.htm .

(2)  Data Report for recommended methods.  When recommended methods from
the Official Methods of Analysis of AOAC International; the Annual Book
of Standards of the American Society for Testing and Materials (Ref. 3);
or, EPA methods are used to develop efficacy data, certain minimal
information, in addition to that described in this guideline, should be
provided in the test report.  The report should include, at the least,
the material in paragraphs (j)(2)(i) through (j)(2)(xii) of this
guideline;

(i)  Test employed, and any significant modifications thereto (e.g.,
organic load, hard water);

(ii)  Test microorganisms employed, including identification of the
specific strain (ATCC or other);

(iii)  Description of the test substance, including the percent of
active ingredient;

(iv)  Concentration or dilution of the product tested and how prepared;

(v)  Number of samples, batches and replicates tested;

(vi)  Manufacture date of each product batch;

(vii)  Identification of all material or procedural options employed,
where such choice is permitted or recommended in the test method
selected (e.g., growth media, drying time for inoculated carriers,
neutralization confirmation and/or subculture media, secondary
subculturing);

(viii)  Test exposure conditions (e.g., contact time, temperature, and
relative humidity);

(ix)  Complete reports of results obtained for each replication;

(x)  Any control data essential to establish the validity of the test.

(xi)  Carrier counts;

(xii) Any additional data pertinent for specific tests described in this
guideline.

(3)  Data for modifications of recommended methods.  When recommended
methods are modified to support specific claims and/or use patterns for
a product, the protocol, identifying and describing each modification,
should be provided with the study report.  The applicant is encouraged
to submit the proposed modification to the Agency for review and
evaluation prior to initiation of the test.

(4)  Data for other methods.  When recommended methods, or modifications
thereto, are not employed to develop efficacy data (such as actual
in-use or many kinds of simulated-use testing), complete testing
protocols should be submitted with the test reports.  All materials and
procedures employed in testing should be described in a manner
consistent with original research reports published in technical or
scientific journals.  Where references to published reports or papers
are made, copies or reprints of such references should be provided with
the test reports.  The applicant should submit the proposed testing
protocols for in-use or simulated-use studies (with a proposed label to
show the claims to be supported by the protocol) to the Agency for
review and evaluation prior to initiation of the test.

(k)  References:  The references in this paragraph may be consulted for
additional background information.

(1)  Official Methods of Analysis of the AOAC International, Chapter 6,
Disinfectants, Official Method 966.04 Sporicidal Activity of
Disinfectants, Eighteenth edition.  AOAC International, Suite 500, 481
North Frederick Avenue, Gaithersburg, MD 20877-2417.

(2)  Official Methods of Analysis of the AOAC International, Chapter 6,
Disinfectants, Official Method 2008.05 Quantitative Three Step Method
(Efficacy of Liquid Sporicides Against Spores of Bacillus subtilis on a
Hard Nonporous Surface), Eighteenth edition.  AOAC International, Suite
500, 481 North Frederick Avenue, Gaithersburg, MD 20877-2417.

(3)  Annual Book of ASTM Standards, Standard Quantitative Carrier Test
Method to Evaluate the Bactericidal, Fungicidal, Mycobactericidal, and
Sporicidal Potencies of Liquid Chemical Germicides, Designation E
2197-02.  American Society for Testing and Materials, 100 Barr Harbor
Drive, West Conshohocken, PA 19428, current edition.

 PAGE  1


[Federal Register Volume 79, Number 226 (Monday, November 24, 2014)]
[Notices]
[Pages 69889-69890]
[FR Doc No: 2014-27695]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request, Copies Available From: U.S. Securities and
Exchange Commission, Office of FOIA Services, 100 F Street NE.,
Washington, DC 20549-2736.

Extension:
    Rule 17Ac2-1, SEC File No. 270-95, OMB Control No. 3235-0084.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (``PRA'') (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the existing
collection of information provided for in Rule 17Ac2-1 (17 CFR
240.17Ac2-1) under the Securities Exchange Act of 1934 (15 U.S.C. 78a
et seq.) (``Exchange Act''). The Commission plans to submit this
existing collection of information to the Office of Management and
Budget (``OMB'') for extension and approval.
    Rule 17Ac2-1, pursuant to Section 17A(c) of the Exchange Act,
generally requires transfer agents to register with their Appropriate
Regulatory Agency (``ARA''), whether the Commission, the Comptroller of
the Currency, the Board of Governors of the Federal Reserve System, the
Federal Deposit Insurance Corporation, or the Office of Thrift
Supervision, and to amend their registrations if the information
becomes inaccurate, misleading, or incomplete.
    Rule 17Ac2-1, pursuant to Section 17A(c) of the Exchange Act,
generally requires transfer agents for whom the Commission is the
transfer agent's Appropriate Regulatory Agency (``ARA''), to file an
application for registration with the Commission on Form TA-1 and to
amend their registrations under certain circumstances.
    Specifically, Rule 17Ac2-1 requires transfer agents to file a Form
TA-1 application for registration with the Commission where the
Commission is their ARA. Such transfer agents must also amend their
Form TA-1 if the existing information on their Form TA-1 becomes
inaccurate, misleading, or incomplete within 60 days following the date
the information became inaccurate, misleading or incomplete.
Registration filings on Form TA-1 and amendments thereto must be filed
with the Commission electronically, absent an exemption, on EDGAR
pursuant to Regulation S-T (17 CFR 232).
    The Commission annually receives approximately 174 filings on Form
TA-1 from transfer agents required to register as such with the
Commission. Included in this figure are approximately 164 amendments
made annually by transfer agents to their Form TA-1 as required by Rule
17Ac2-1(c) to address information that has become inaccurate,
misleading, or incomplete and approximately 10 new applications by
transfer agents for registration on Form TA-1 as required by Rule
17Ac2-1(a). Based on past submissions, the staff estimates that on
average approximately twelve hours are required for initial completion
of Form TA-1 and that on average one and one-half hours are required
for an amendment to Form TA-1 by each such firm. Thus, the subtotal
burden for new applications for registration filed on Form TA-1 each
year is 120 hours (12 hours times 10 filers) and the subtotal burden
for amendments to Form TA-1 filed each year is 246 hours (1.5 hours
times 164 filers). The cumulative total is 366 burden hours per year
(120 hours plus 246 hours).
    Written comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the Commission, including whether the information
shall have practical utility; (b) the accuracy of the Commission's
estimates of the burden of the proposed collection of information; (c)
ways to enhance the quality, utility, and clarity of the information to
be collected; and (d) ways to minimize the burden of the collection of
information on respondents, including the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted within 60 days of this
publication.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    Please direct your written comments to: Pamela Dyson, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send
an email to<EMAIL_ADDRESS>
    Dated: November 18, 2014.
Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-27695 Filed 11-21-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 85, Number 207 (Monday, October 26, 2020)]
[Notices]
[Pages 67744-67746]
[FR Doc No: 2020-23398]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1869]

Alignment of Third-Party Food Safety Standards With Food Safety
Regulations: Notice of Pilot Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
seeking requests for participation from members of the public,
including owners of third-party human food safety standards, interested
in participating in a voluntary pilot program to evaluate third-party
food safety standards. On July 13, 2020, FDA announced the New Era of
Smarter Food Safety Blueprint and the desire to explore the increased
use of reliable third-party audits to help ensure safer food, including
exploring the use of reliable audit data in risk-prioritization for FDA
regulatory activities, for example, with respect to inspections of both
imported and domestically produced foods. Under the pilot program, FDA
will assess third-party food safety standards for alignment with
certain FDA food safety regulations. Knowing that these third-party
standards align with certain FDA food safety regulations would give
those relying on audits conducted to those standards confidence that
they are meeting certain FDA requirements for supplier verification
audits. The pilot will enable FDA to gain information and experience
that will allow the Agency to evaluate the resources and tools required
to conduct alignment reviews.

DATES: The pilot will conclude October 26, 2021.

ADDRESSES: Submit written or electronic submissions for the pilot
program to<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Franciel Ikeji, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Ensuring the safety of food for human and animal use is a shared
responsibility between the public and private sectors. FDA has
established regulatory standards, inspects facilities, and may take
action if there are violations. But it is primarily the responsibility
of industry to ensure that food products intended for human and animal
consumption in the United States are safe and meet applicable food
safety requirements. The FDA Food Safety Modernization Act (FSMA) (Pub.
L. 111-353) modified the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 301, et seq..) to establish a framework that focuses on
prevention and recognizes the important part we all play in protecting
consumers from unsafe food.
    FSMA and the implementing regulations place new obligations on
certain entities in the food industry to verify that their suppliers
are meeting FDA safety standards. More specifically, three regulations
that FDA issued under FSMA have supplier verification requirements.
Those regulations are the Current Good Manufacturing Practice, Hazard
Analysis, and Risk-Based Preventive Controls for Human Food (PCHF)
regulation (part 117 (21 CFR part 117)); the Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food
for Animals (PCAF) regulation (part 507 (21 CFR part 507)); and Foreign
Supplier Verification Programs for Food Importers (FSVP) regulation (21
CFR part 1, subpart L). Subparts A, C, D, E, F, and G of part 117 in
the PCHF regulation include requirements for domestic and foreign
facilities that are required to register under section 415 of the FD&C
Act (21 U.S.C. 350d) to conduct a hazard analysis and implement risk-
based preventive controls for human food (the human food preventive
controls requirements). Subpart G of part 117 requires the receiving
facility to establish and implement a written supply-chain program (21
CFR 117.405(a) and (b)) and conduct appropriate supplier verification
activities for those raw materials and other ingredients for which the
receiving facility has identified a hazard requiring a supply-chain-
applied control (21 CFR 117.425 and 117.415(a)(3)(iii)). Generally,
when a hazard in a raw material or other 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, the

appropriate supplier verification activity is an onsite audit of the
supplier, and it must be conducted before using the food and at least
annually thereafter (Sec.  117.430(b)(1) (21 CFR 117.430(b)(1))).
    For animal food facilities that are required to register, subparts
A, C, D, E, and F of part 507 in PCAF include requirements to conduct a
hazard analysis and implement risk-based preventive controls for animal
food (the animal food preventive controls requirements). Subpart E of
part 507 establishes requirements, similar to those in PCHF, for a
supply-chain program for those raw materials and other ingredients for
which a receiving facility has identified a hazard requiring a supply-
chain-applied control.
    Under the FSVP regulation, FSVP importers are required to develop,
maintain, and follow a foreign supplier verification program that
provides adequate assurances that imported food meets applicable U.S.
food safety standards. The FSVP regulation requires importers to
conduct a hazard analysis to determine whether there are any hazards
that require a control (21 CFR 1.504) and, based on the hazard
analysis, determine the appropriate type of verification activity as
well as the frequency of conducting the activity. When a hazard in a
food is controlled by the foreign supplier and is one for which there
is a reasonable probability that exposure to the hazard will cause
serious adverse health consequences or death to humans or animals, the
default verification activity is to conduct an annual onsite audit
before initially importing the food from the supplier and at least
annually thereafter (Sec.  1.506(d)(2) (21 CFR 1.506(d)(2))).
    In all three regulations, audits are not required if the receiving
facility or importer has made a written determination that other
verification activities and/or less frequent onsite auditing of the
supplier provide adequate verification. See Sec. Sec.  1.506(d)(2),
117.430(b)(2), and 507.130(b)(2).
    The FSMA supply-chain programs do not require these annual onsite
audits to be conducted by auditors accredited under FDA's Accredited
Third-Party Certification Programs (21 CFR part 1, subpart M), which
established a voluntary program for the accreditation of third-party
certification bodies to conduct food safety audits and issue
certifications for foreign facilities. The PCHF, PCAF, and FSVP
regulations do, however, require the onsite audits under these
regulations to be conducted by ``qualified auditors. '' (A qualified
auditor means a person who has the technical expertise obtained through
education, training, or experience (or a combination thereof) necessary
to perform the auditing function). See 21 CFR 1.500, 117.3, and 507.3.
Importantly, too, the audits must consider applicable FDA regulations.
See 21 CFR 1.506(e)(1)(i), 117.435, and 507.135.
    FDA is aware that there are a variety of third-party food safety
standards used by industry to assess a supplier's performance and that
importers and receiving facilities may voluntarily rely on audits that
use those private standards. Because the supply-chain verification
provisions of PCHF, PCAF, and FSVP require that audits consider
applicable FDA food safety regulations, importers and receiving
facilities may seek assurances regarding how these standards align with
FDA food safety standards. Having such assurances may provide importers
and receiving facilities with confidence that they can use audits
conducted under the standards to fulfill the PCHF, PCAF, and FSVP
requirements for supplier verification. This pilot will assess whether
some of these third-party food safety standards are aligned with food
safety requirements in two specific FDA human food safety regulations:
The PCHF regulation and the Standards for the Growing, Harvesting,
Packing, and Holding of Produce for Human Consumption (Produce Safety)
regulation (21 CFR part 112). The pilot will not assess alignment with
FDA animal food safety regulations.
    FDA has published templates that may be used to help receiving
facilities, importers, and other stakeholders compare the third-party
food safety standards used in an audit to the food safety requirements
in applicable FDA regulations (FDA Audit Comparison Templates) https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm602286.htm. The templates
are arranged in a table format for easy comparison of the third-party
food safety standards to the food safety requirements of FDA
regulations.
    While these templates are useful, the pilot will allow us to assess
how the third-party food safety standards used in audits align with
human food safety requirements in the PCHF and the Produce Safety
regulations. We expect that FDA alignment determinations would create
efficiencies for industry, so that importers and receiving facilities
know whether the third-party food safety standards used to audit their
suppliers adequately consider food safety requirements in two of FDA's
regulations. Similarly, we expect that it would be more efficient for
FDA investigators to know if the standards against which a supplier was
audited align with FDA regulations, so that the investigators can more
efficiently determine whether importers and receiving facilities are in
compliance with the FSMA supply-chain verification requirements for
audits. The pilot will assist FDA in gathering information to determine
whether these expectations are accurate.
    The pilot will also evaluate the process for determining alignment,
including the resources required for FDA to review and assess third-
party standards for alignment with relevant FDA regulations. While the
pilot will be focused on human food safety requirements in the PCHF and
Produce Safety regulations, any program that FDA puts in place as a
result of the Agency's experience with the pilot would likely also
include a review of standards for food for animal consumption to assess
and determine alignment of third-party animal food safety standards to
the food safety requirements in the PCAF regulation.
    We also note that the goals of this pilot align with the ``FDA
Strategy for the Safety of Imported Food,'' which includes an objective
that FDA take into account the public health assurances of reliable
audits such as those issued under FDA's Accredited Third-Party
Certification Program or pursuant to other assurance programs aligned
with FDA food safety requirements. FDA recognizes that audits can
provide valuable public health assurances if they are reliable and if
the standards under which audits are conducted are aligned with
relevant FDA food safety regulations. The goals of the program also
align with the New Era of Smarter Food Safety Blueprint. As explained
in the Blueprint, FDA is considering the benefits of using reliable
audit information in resource allocation decision making and risk
prioritization of regulatory activities such as import screening to
ensure that food offered for import meets U.S. food safety
requirements. Because this pilot is only focused on assessing third-
party food safety standards, and not the overall quality of audit
programs or the qualifications of auditors, we believe that the pilot
will help evaluate the requirements for making alignment determinations
as an important step in determining the reliability of third-party
audits.

II. FDA Determination of Alignment of Third-Party Food Safety Standards
Voluntary Pilot Program

A. Scope and Selection Attributes

    FDA is seeking requests for participation from members of the
public, including owners of third-party human food safety standards,
who are interested in participating in a voluntary pilot program to
determine whether third-party food safety standards align with food
safety requirements in the PCHF and the Produce Safety regulations.
Upon being selected to participate in the program, participants will
submit their standards for assessment. FDA plans to select and assess
up to five private third-party human food safety standards for
alignment with food safety requirements in the PCHF or the Produce
Safety regulation. Participants in the pilot program will be asked to
provide FDA with technical feedback on the pilot. The Agency will use
its discretion in choosing participants for assessment based on (in no
particular order):
    (1) The order the requests for participation are received;
    (2) the desired diversity of third-party human food safety
standards for assessment in the pilot (e.g., PCHF, Produce Safety); and
    (3) the Agency's determination of available resources to conduct
the assessment given the level of effort and other priorities.
    FDA reserves the right to request additional information or
clarification from participants in the pilot and to rescind
participation if the additional information or clarification is not
promptly and accurately provided.

B. Duration

    The pilot will run for 1 year from the date of publication of this
notice and will conclude on October 26, 2021. FDA reserves the right to
extend the pilot for more time as needed. To assure we have adequate
time to assess the standards during the pilot period, we are asking
members of the public, including owners of third-party human food
safety standards, to submit their request to participate in the pilot
program by November 25, 2020.

C. Submission of Requests To Participate

    Members of the public, including owners of third-party human food
safety standards, that are interested in participating should submit a
written request to participate to Franciel Ikeji (see FOR FURTHER
INFORMATION CONTACT). Electronic requests should be submitted to
<EMAIL_ADDRESS>We strongly encourage interested
persons to electronically submit their requests to participate. Written
and electronic requests to participate in the pilot program should be
submitted by November 25, 2020.
    The request to participate should include the following
information: Company and contact name; contact phone number; and
contact email address. Additionally, although not required for
consideration, FDA is particularly interested in whether you are the
owner of a third-party food safety standard, and the type of food
safety standard you have developed (e.g., produce safety, human
processed food). For a limited number of applicants that FDA identifies
as possible candidates for participation in the pilot, FDA may ask you
to submit a completed FDA Food Safety Audit Comparison Template https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm602286.htm. If the pilot
participant chooses to submit an alternative comparison tool, the
format should enable FDA to easily compare the third-party food safety
standard to the relevant FDA regulations (i.e., placing the relevant
requirements of FDA's regulations in numerical order to the left of any
third-party food safety standards). FDA may also ask pilot participants
for additional information on submitted food safety standards.

D. Assessment and Alignment of Program Standards

    The pilot program will be conducted from October 26, 2020 to
October 26, 2021 and may be extended as needed. Each person that
submits a request to participate will be notified that FDA has received
the request. This notification only acknowledges that FDA has received
the request and does not guarantee that FDA will accept you for
participation in the pilot. By the conclusion of the pilot,
participants will be notified as to whether FDA determined the food
safety standard to be in alignment or not in alignment with the
relevant FDA regulation.
    FDA will publish information on its website regarding the third-
party standards that FDA determines to be in alignment with FDA
regulations.

E. Evaluation of Pilot Program

    FDA intends to evaluate the pilot program on several factors,
including, but not limited to, the resources required to review and
assess third-party standards for alignment with relevant FDA
regulations, the ability of pilot participants to provide adequate
information to enable FDA to make a determination of alignment, and
whether FDA Audit Comparison Templates are a helpful tool in making
alignment determinations. After FDA evaluates the pilot program, the
Agency will utilize the information to evaluate the resources and tools
required to conduct alignment reviews.

    Dated: October 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23398 Filed 10-23-20; 8:45 am]
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