82_FR_14685 82 FR 14631 - Aspergillus flavus AF36; Amendment to an Exemption From the Requirement of a Tolerance

82 FR 14631 - Aspergillus flavus AF36; Amendment to an Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 82, Issue 54 (March 22, 2017)

Page Range14631-14632
FR Document2017-05720

This regulation amends the existing tolerance exemption for Aspergillus flavus AF36 by establishing an exemption from the requirement of a tolerance for residues of Aspergillus flavus AF36 in or on almond and fig when used in accordance with label directions and good agricultural practices. Interregional Research Project Number 4 submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting that EPA amend the existing tolerance exemption for Aspergillus flavus AF36. This regulation eliminates the need to establish a maximum permissible level for residues of Aspergillus flavus AF36 under FFDCA.

Federal Register, Volume 82 Issue 54 (Wednesday, March 22, 2017)
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Rules and Regulations]
[Pages 14631-14632]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05720]



[[Page 14631]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2016-0566; FRL-9959-92]


Aspergillus flavus AF36; Amendment to an Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation amends the existing tolerance exemption for 
Aspergillus flavus AF36 by establishing an exemption from the 
requirement of a tolerance for residues of Aspergillus flavus AF36 in 
or on almond and fig when used in accordance with label directions and 
good agricultural practices. Interregional Research Project Number 4 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting that EPA amend the existing tolerance exemption 
for Aspergillus flavus AF36. This regulation eliminates the need to 
establish a maximum permissible level for residues of Aspergillus 
flavus AF36 under FFDCA.

DATES: This regulation is effective March 22, 2017. Objections and 
requests for hearings must be received on or before May 22, 2017, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2016-0566, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2016-0566 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 22, 2017. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2016-0566, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of November 30, 2016 (81 FR 86312) (FRL-
9954-06), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 6E8471) by Interregional Research Project Number 4 (IR-4), 
Rutgers University, 500 College Rd. East, Suite 201W, Princeton, NJ 
08540. The petition requested that 40 CFR 180.1206 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of Aspergillus flavus AF36 in or on almond and fig. That 
document referenced a summary of the petition prepared by the 
petitioner IR-4, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include

[[Page 14632]]

occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which require EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance or tolerance exemption and 
to ``ensure that there is a reasonable certainty that no harm will 
result to infants and children from aggregate exposure to the pesticide 
chemical residue . . . .'' Additionally, FFDCA section 408(b)(2)(D) 
requires that EPA consider ``available information concerning the 
cumulative effects of a particular pesticide's . . . residues and other 
substances that have a common mechanism of toxicity.''
    EPA evaluated the available toxicity and exposure data on 
Aspergillus flavus AF36 and considered their validity, completeness, 
and reliability, as well as the relationship of this information to 
human risk. A full explanation of the data upon which EPA relied and 
its risk assessment based on those data can be found within the 
February 2017, document entitled ``Federal Food, Drug, and Cosmetic Act 
(FFDCA) Considerations for Aspergillus flavus AF36.'' This document, as 
well as other relevant information, is available in the docket for this 
action as described under ADDRESSES.
    Based upon its evaluation, EPA concludes that Aspergillus flavus 
AF36 is not toxic, not pathogenic, and not infective. Although there 
may be some exposure to residues when Aspergillus flavus AF36 is used 
on fig and almond in accordance with label directions and good 
agricultural practices, there is a lack of concern due to the lack of 
potential for adverse effects. EPA also determined that retention of 
the Food Quality Protection Act (FQPA) safety factor was not necessary 
as part of the qualitative assessment conducted for Aspergillus flavus 
AF36.
    Based upon its evaluation, EPA concludes that there is a reasonable 
certainty that no harm will result to the U.S. population, including 
infants and children, from aggregate exposure to residues of 
Aspergillus flavus AF36. Therefore, the existing tolerance exemption 
for Aspergillus flavus AF36 is amended by establishing an exemption 
from the requirement of a tolerance for residues of Aspergillus flavus 
AF36 in or on almond and fig when used in accordance with label 
directions and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes 
because EPA is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section 
408(d) in response to a petition submitted to EPA. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled ``Regulatory Planning and 
Review'' (58 FR 51735, October 4, 1993). Because this action has been 
exempted from review under Executive Order 12866, this action is not 
subject to Executive Order 13211, entitled ``Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use'' (66 FR 28355, May 22, 2001), or Executive Order 13045, entitled 
``Protection of Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any 
special considerations under Executive Order 12898, entitled ``Federal 
Actions to Address Environmental Justice in Minority Populations and 
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the tolerance 
exemption in this action, do not require the issuance of a proposed 
rule, the requirements of the Regulatory Flexibility Act (RFA) (5 
U.S.C. 601 et seq.) do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes. As a result, this 
action does not alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, EPA has determined that this 
action will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, EPA has determined that 
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10, 
1999), and Executive Order 13175, entitled ``Consultation and 
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9, 
2000), do not apply to this action. In addition, this action does not 
impose any enforceable duty or contain any unfunded mandate as 
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require EPA's consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 7, 2017.
Robert McNally,
Director, Biopesticides and Pollution Prevention Division, Office of 
Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.


0
2. In Sec.  180.1206, add paragraph (e) to read as follows:


Sec.  180.1206  Aspergillus flavus AF36; exemption from the requirement 
of a tolerance.

* * * * *
    (e) An exemption from the requirement of a tolerance is established 
for residues of Aspergillus flavus AF36 in or on almond and fig when 
used in accordance with label directions and good agricultural 
practices.

[FR Doc. 2017-05720 Filed 3-21-17; 8:45 am]
BILLING CODE 6560-50-P



                                                                 Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations                                         14631

                                                ENVIRONMENTAL PROTECTION                                number: (703) 305–7090; email address:                2016–0566, by one of the following
                                                AGENCY                                                  BPPDFRNotices@epa.gov.                                methods:
                                                                                                        SUPPLEMENTARY INFORMATION:                              • Federal eRulemaking Portal: http://
                                                40 CFR Part 180
                                                                                                        I. General Information                                www.regulations.gov. Follow the online
                                                                                                                                                              instructions for submitting comments.
                                                [EPA–HQ–OPP–2016–0566; FRL–9959–92]                     A. Does this action apply to me?                      Do not submit electronically any
                                                                                                           You may be potentially affected by                 information you consider to be CBI or
                                                Aspergillus flavus AF36; Amendment
                                                to an Exemption From the                                this action if you are an agricultural                other information whose disclosure is
                                                Requirement of a Tolerance                              producer, food manufacturer, or                       restricted by statute.
                                                                                                        pesticide manufacturer. The following                   • Mail: OPP Docket, Environmental
                                                AGENCY:  Environmental Protection                       list of North American Industrial                     Protection Agency Docket Center (EPA/
                                                Agency (EPA).                                           Classification System (NAICS) codes is                DC), (28221T), 1200 Pennsylvania Ave.
                                                ACTION: Final rule.                                     not intended to be exhaustive, but rather             NW., Washington, DC 20460–0001.
                                                                                                        provides a guide to help readers
                                                SUMMARY:   This regulation amends the                   determine whether this document                         • Hand Delivery: To make special
                                                existing tolerance exemption for                        applies to them. Potentially affected                 arrangements for hand delivery or
                                                Aspergillus flavus AF36 by establishing                 entities may include:                                 delivery of boxed information, please
                                                an exemption from the requirement of a                     • Crop production (NAICS code 111).                follow the instructions at http://
                                                tolerance for residues of Aspergillus                      • Animal production (NAICS code                    www.epa.gov/dockets/contacts.html.
                                                flavus AF36 in or on almond and fig                     112).                                                 Additional instructions on commenting
                                                when used in accordance with label                         • Food manufacturing (NAICS code                   or visiting the docket, along with more
                                                directions and good agricultural                        311).                                                 information about dockets generally, is
                                                practices. Interregional Research Project                  • Pesticide manufacturing (NAICS                   available at http://www.epa.gov/
                                                Number 4 submitted a petition to EPA                    code 32532).                                          dockets.
                                                under the Federal Food, Drug, and
                                                                                                        B. How can I get electronic access to                 II. Background
                                                Cosmetic Act (FFDCA), requesting that
                                                EPA amend the existing tolerance                        other related information?
                                                                                                                                                                 In the Federal Register of November
                                                exemption for Aspergillus flavus AF36.                    You may access a frequently updated                 30, 2016 (81 FR 86312) (FRL–9954–06),
                                                This regulation eliminates the need to                  electronic version of 40 CFR part 180                 EPA issued a document pursuant to
                                                establish a maximum permissible level                   through the Government Publishing                     FFDCA section 408(d)(3), 21 U.S.C.
                                                for residues of Aspergillus flavus AF36                 Office’s e-CFR site at http://                        346a(d)(3), announcing the filing of a
                                                under FFDCA.                                            www.ecfr.gov/cgi-bin/text-                            pesticide tolerance petition (PP 6E8471)
                                                DATES: This regulation is effective                     idx?&c=ecfr&tpl=/ecfrbrowse/Title40/                  by Interregional Research Project
                                                March 22, 2017. Objections and requests                 40tab_02.tpl.                                         Number 4 (IR–4), Rutgers University,
                                                for hearings must be received on or                     C. How can I file an objection or hearing             500 College Rd. East, Suite 201W,
                                                before May 22, 2017, and must be filed                  request?                                              Princeton, NJ 08540. The petition
                                                in accordance with the instructions                                                                           requested that 40 CFR 180.1206 be
                                                provided in 40 CFR part 178 (see also                     Under FFDCA section 408(g), 21
                                                                                                        U.S.C. 346a(g), any person may file an                amended by establishing an exemption
                                                Unit I.C. of the SUPPLEMENTARY                                                                                from the requirement of a tolerance for
                                                INFORMATION).
                                                                                                        objection to any aspect of this regulation
                                                                                                        and may also request a hearing on those               residues of Aspergillus flavus AF36 in
                                                ADDRESSES:    The docket for this action,               objections. You must file your objection              or on almond and fig. That document
                                                identified by docket identification (ID)                or request a hearing on this regulation               referenced a summary of the petition
                                                number EPA–HQ–OPP–2016–0566, is                         in accordance with the instructions                   prepared by the petitioner IR–4, which
                                                available at http://www.regulations.gov                 provided in 40 CFR part 178. To ensure                is available in the docket via http://
                                                or at the Office of Pesticide Programs                  proper receipt by EPA, you must                       www.regulations.gov. There were no
                                                Regulatory Public Docket (OPP Docket)                   identify docket ID number EPA–HQ–                     comments received in response to the
                                                in the Environmental Protection Agency                  OPP–2016–0566 in the subject line on                  notice of filing.
                                                Docket Center (EPA/DC), West William                    the first page of your submission. All
                                                Jefferson Clinton Bldg., Rm. 3334, 1301                                                                       III. Final Rule
                                                                                                        objections and requests for a hearing
                                                Constitution Ave. NW., Washington, DC                   must be in writing, and must be                       A. EPA’s Safety Determination
                                                20460–0001. The Public Reading Room                     received by the Hearing Clerk on or
                                                is open from 8:30 a.m. to 4:30 p.m.,                    before May 22, 2017. Addresses for mail                  Section 408(c)(2)(A)(i) of FFDCA
                                                Monday through Friday, excluding legal                  and hand delivery of objections and                   allows EPA to establish an exemption
                                                holidays. The telephone number for the                  hearing requests are provided in 40 CFR               from the requirement for a tolerance (the
                                                Public Reading Room is (202) 566–1744,                  178.25(b).                                            legal limit for a pesticide chemical
                                                and the telephone number for the OPP                      In addition to filing an objection or               residue in or on a food) only if EPA
                                                Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk                determines that the exemption is ‘‘safe.’’
                                                the visitor instructions and additional                 as described in 40 CFR part 178, please               Section 408(c)(2)(A)(ii) of FFDCA
                                                information about the docket available                  submit a copy of the filing (excluding                defines ‘‘safe’’ to mean that ‘‘there is a
                                                at http://www.epa.gov/dockets.                          any Confidential Business Information                 reasonable certainty that no harm will
jstallworth on DSK7TPTVN1PROD with RULES




                                                FOR FURTHER INFORMATION CONTACT:                        (CBI)) for inclusion in the public docket.            result from aggregate exposure to the
                                                Robert McNally, Biopesticides and                       Information not marked confidential                   pesticide chemical residue, including
                                                Pollution Prevention Division (7511P),                  pursuant to 40 CFR part 2 may be                      all anticipated dietary exposures and all
                                                Office of Pesticide Programs,                           disclosed publicly by EPA without prior               other exposures for which there is
                                                Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your               reliable information.’’ This includes
                                                Pennsylvania Ave. NW., Washington,                      objection or hearing request, identified              exposure through drinking water and in
                                                DC 20460–0001; main telephone                           by docket ID number EPA–HQ–OPP–                       residential settings but does not include


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                                                14632            Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Rules and Regulations

                                                occupational exposure. Pursuant to                      B. Analytical Enforcement Methodology                 1999), and Executive Order 13175,
                                                FFDCA section 408(c)(2)(B), in                             An analytical method is not required               entitled ‘‘Consultation and Coordination
                                                establishing or maintaining in effect an                for enforcement purposes because EPA                  with Indian Tribal Governments’’ (65 FR
                                                exemption from the requirement of a                     is establishing an exemption from the                 67249, November 9, 2000), do not apply
                                                tolerance, EPA must take into account                   requirement of a tolerance without any                to this action. In addition, this action
                                                the factors set forth in FFDCA section                  numerical limitation.                                 does not impose any enforceable duty or
                                                408(b)(2)(C), which require EPA to give                                                                       contain any unfunded mandate as
                                                special consideration to exposure of                    IV. Statutory and Executive Order                     described under Title II of the Unfunded
                                                infants and children to the pesticide                   Reviews                                               Mandates Reform Act (UMRA) (2 U.S.C.
                                                chemical residue in establishing a                         This action establishes a tolerance                1501 et seq.).
                                                tolerance or tolerance exemption and to                 exemption under FFDCA section 408(d)                    This action does not involve any
                                                ‘‘ensure that there is a reasonable                     in response to a petition submitted to                technical standards that would require
                                                certainty that no harm will result to                   EPA. The Office of Management and                     EPA’s consideration of voluntary
                                                infants and children from aggregate                     Budget (OMB) has exempted these types                 consensus standards pursuant to section
                                                exposure to the pesticide chemical                      of actions from review under Executive                12(d) of the National Technology
                                                residue . . . .’’ Additionally, FFDCA                   Order 12866, entitled ‘‘Regulatory                    Transfer and Advancement Act
                                                section 408(b)(2)(D) requires that EPA                  Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                                consider ‘‘available information                        October 4, 1993). Because this action
                                                concerning the cumulative effects of a                  has been exempted from review under                   V. Congressional Review Act
                                                particular pesticide’s . . . residues and               Executive Order 12866, this action is
                                                other substances that have a common                     not subject to Executive Order 13211,                   Pursuant to the Congressional Review
                                                mechanism of toxicity.’’                                entitled ‘‘Actions Concerning                         Act (5 U.S.C. 801 et seq.), EPA will
                                                   EPA evaluated the available toxicity                 Regulations That Significantly Affect                 submit a report containing this rule and
                                                and exposure data on Aspergillus flavus                 Energy Supply, Distribution, or Use’’ (66             other required information to the U.S.
                                                AF36 and considered their validity,                     FR 28355, May 22, 2001), or Executive                 Senate, the U.S. House of
                                                completeness, and reliability, as well as               Order 13045, entitled ‘‘Protection of                 Representatives, and the Comptroller
                                                the relationship of this information to                 Children from Environmental Health                    General of the United States prior to
                                                human risk. A full explanation of the                   Risks and Safety Risks’’ (62 FR 19885,                publication of the rule in the Federal
                                                data upon which EPA relied and its risk                 April 23, 1997). This action does not                 Register. This action is not a ‘‘major
                                                assessment based on those data can be                   contain any information collections                   rule’’ as defined by 5 U.S.C. 804(2).
                                                found within the February 2017,                         subject to OMB approval under the                     List of Subjects in 40 CFR Part 180
                                                document entitled ‘‘Federal Food, Drug,                 Paperwork Reduction Act (PRA), 44
                                                and Cosmetic Act (FFDCA)                                U.S.C. 3501 et seq., nor does it require                Environmental protection,
                                                Considerations for Aspergillus flavus                   any special considerations under                      Administrative practice and procedure,
                                                AF36.’’ This document, as well as other                 Executive Order 12898, entitled                       Agricultural commodities, Pesticides
                                                relevant information, is available in the               ‘‘Federal Actions to Address                          and pests, Reporting and recordkeeping
                                                docket for this action as described under               Environmental Justice in Minority                     requirements.
                                                ADDRESSES.                                              Populations and Low-Income                              Dated: March 7, 2017.
                                                   Based upon its evaluation, EPA                       Populations’’ (59 FR 7629, February 16,
                                                concludes that Aspergillus flavus AF36                                                                        Robert McNally,
                                                                                                        1994).
                                                is not toxic, not pathogenic, and not                      Since tolerances and exemptions that               Director, Biopesticides and Pollution
                                                infective. Although there may be some                   are established on the basis of a petition            Prevention Division, Office of Pesticide
                                                exposure to residues when Aspergillus                   under FFDCA section 408(d), such as                   Programs.
                                                flavus AF36 is used on fig and almond                   the tolerance exemption in this action,                 Therefore, 40 CFR chapter I is
                                                in accordance with label directions and                 do not require the issuance of a                      amended as follows:
                                                good agricultural practices, there is a                 proposed rule, the requirements of the
                                                lack of concern due to the lack of                      Regulatory Flexibility Act (RFA) (5                   PART 180—[AMENDED]
                                                potential for adverse effects. EPA also                 U.S.C. 601 et seq.) do not apply.
                                                determined that retention of the Food                      This action directly regulates growers,            ■ 1. The authority citation for part 180
                                                Quality Protection Act (FQPA) safety                    food processors, food handlers, and food              continues to read as follows:
                                                factor was not necessary as part of the                 retailers, not States or tribes. As a result,
                                                qualitative assessment conducted for                    this action does not alter the                            Authority: 21 U.S.C. 321(q), 346a and 371.
                                                Aspergillus flavus AF36.                                relationships or distribution of power
                                                                                                                                                              ■ 2. In § 180.1206, add paragraph (e) to
                                                   Based upon its evaluation, EPA                       and responsibilities established by
                                                                                                                                                              read as follows:
                                                concludes that there is a reasonable                    Congress in the preemption provisions
                                                certainty that no harm will result to the               of FFDCA section 408(n)(4). As such,                  § 180.1206 Aspergillus flavus AF36;
                                                U.S. population, including infants and                  EPA has determined that this action will              exemption from the requirement of a
                                                children, from aggregate exposure to                    not have a substantial direct effect on               tolerance.
                                                residues of Aspergillus flavus AF36.                    States or tribal governments, on the                  *     *    *     *    *
                                                Therefore, the existing tolerance                       relationship between the national
                                                exemption for Aspergillus flavus AF36                   government and the States or tribal                     (e) An exemption from the
                                                                                                                                                              requirement of a tolerance is established
jstallworth on DSK7TPTVN1PROD with RULES




                                                is amended by establishing an                           governments, or on the distribution of
                                                exemption from the requirement of a                     power and responsibilities among the                  for residues of Aspergillus flavus AF36
                                                tolerance for residues of Aspergillus                   various levels of government or between               in or on almond and fig when used in
                                                flavus AF36 in or on almond and fig                     the Federal Government and Indian                     accordance with label directions and
                                                when used in accordance with label                      tribes. Thus, EPA has determined that                 good agricultural practices.
                                                directions and good agricultural                        Executive Order 13132, entitled                       [FR Doc. 2017–05720 Filed 3–21–17; 8:45 am]
                                                practices.                                              ‘‘Federalism’’ (64 FR 43255, August 10,               BILLING CODE 6560–50–P




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Document Created: 2017-03-22 03:58:30
Document Modified: 2017-03-22 03:58:30
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
DatesThis regulation is effective March 22, 2017. Objections and requests for hearings must be received on or before May 22, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ContactRobert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email
FR Citation82 FR 14631 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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