80_FR_73888 80 FR 73661 - Aureobasidium Pullulans Strains DSM 14940 and DSM 14941; Exemption From the Requirement of a Tolerance

80 FR 73661 - Aureobasidium Pullulans Strains DSM 14940 and DSM 14941; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 227 (November 25, 2015)

Page Range73661-73662
FR Document2015-29888

This regulation amends an existing exemption from the requirement of a tolerance for residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941 to include residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941 in or on all food commodities when used in accordance with label directions and good agricultural practices. Bio-ferm GmbH submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment of the exemption from the requirement of a tolerance that includes food commodities that are treated post-harvest. This regulation eliminates the need to establish a maximum permissible level for residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941 under FFDCA.

Federal Register, Volume 80 Issue 227 (Wednesday, November 25, 2015)
[Federal Register Volume 80, Number 227 (Wednesday, November 25, 2015)]
[Rules and Regulations]
[Pages 73661-73662]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29888]



[[Page 73661]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0099; FRL-9936-50]


Aureobasidium Pullulans Strains DSM 14940 and DSM 14941; 
Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation amends an existing exemption from the 
requirement of a tolerance for residues of Aureobasidium pullulans 
strains DSM 14940 and DSM 14941 to include residues of Aureobasidium 
pullulans strains DSM 14940 and DSM 14941 in or on all food commodities 
when used in accordance with label directions and good agricultural 
practices. Bio-ferm GmbH submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment of the 
exemption from the requirement of a tolerance that includes food 
commodities that are treated post-harvest. This regulation eliminates 
the need to establish a maximum permissible level for residues of 
Aureobasidium pullulans strains DSM 14940 and DSM 14941 under FFDCA.

DATES: This regulation is effective November 25, 2015. Objections and 
requests for hearings must be received on or before January 25, 2016, 
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-2010-0099, 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 Printing 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-2010-0099 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 
January 25, 2016. 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-2010-0099, 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

    An exemption from the requirement of a tolerance for residues of 
the Aureobasidium pullulans strains DSM 14940 and DSM 14941 in or on 
all food commodities when applied pre-harvest and used in accordance 
with good agricultural practices was established and published in the 
Federal Register of February 15, 2012 (77 FR 8731) (FRL-9337-3). In the 
Federal Register of July 17, 2015 (80 FR 42462) (FRL-9929-13), 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 
4F8342) by bio-ferm GmbH, Technologiezentrum Tulln, Technopark 1, 
Tulln, 3430, Austria. The petition requested that 40 CFR 180.1312 be 
amended by expanding the current exemption to also include food 
commodities that are treated post-harvest. Therefore an exemption from 
the requirement of a tolerance for residues of Aureobasidium pullulans 
strains DSM 14940 and DSM 14941 in or on all food commodities was 
proposed. The Notice of Filing referenced a summary of the petition 
prepared by the petitioner bio-ferm GmbH, 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

[[Page 73662]]

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 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 
Aureobasidium pullulans strains DSM 14940 and DSM 14941 and considered 
its 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 that 
data can be found within the October 15, 2015, document entitled 
``Federal Food, Drug, and Cosmetic Act (FFDCA) considerations for 
Aureobasidium pullulans strains DSM 14940 and DSM 14941''. 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 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 Aureobasidium 
pullulans strains DSM 14940 and DSM 14941. Therefore, an exemption from 
the requirement of a tolerance is established for residues of 
Aureobasidium pullulans strains DSM 14940 and DSM 14941 in or on all 
food commodities when used in accordance with label directions and good 
agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for 
the reasons contained in the October 15, 2015, document entitled 
``Federal Food, Drug, and Cosmetic Act (FFDCA) considerations for 
Aureobasidium pullulans strains DSM 14940 and DSM 14941'' and 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: November 5, 2015.
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. Revise Sec.  180.1312 to read as follows:


Sec.  180.1312  Aureobasidium pullulans strains DSM 14940 and DSM 
14941; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Aureobasidium pullulans strains DSM 14940 and DSM 14941 in 
or on all food commodities when used in accordance with label 
directions and good agricultural practices.
[FR Doc. 2015-29888 Filed 11-24-15; 8:45 am]
 BILLING CODE 6560-50-P



                                                             Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Rules and Regulations                                        73661

                                                ENVIRONMENTAL PROTECTION                                Pennsylvania Ave. NW., Washington,                    objection or hearing request, identified
                                                AGENCY                                                  DC 20460–0001; main telephone                         by docket ID number EPA–HQ–OPP–
                                                                                                        number: (703) 305–7090; email address:                2010–0099, by one of the following
                                                40 CFR Part 180                                         BPPDFRNotices@epa.gov.                                methods:
                                                [EPA–HQ–OPP–2010–0099; FRL–9936–50]                     SUPPLEMENTARY INFORMATION:                              • Federal eRulemaking Portal: http://
                                                                                                                                                              www.regulations.gov. Follow the online
                                                                                                        I. General Information                                instructions for submitting comments.
                                                Aureobasidium Pullulans Strains DSM
                                                14940 and DSM 14941; Exemption                          A. Does this action apply to me?                      Do not submit electronically any
                                                From the Requirement of a Tolerance                                                                           information you consider to be CBI or
                                                                                                           You may be potentially affected by                 other information whose disclosure is
                                                AGENCY:  Environmental Protection                       this action if you are an agricultural                restricted by statute.
                                                Agency (EPA).                                           producer, food manufacturer, or                         • Mail: OPP Docket, Environmental
                                                ACTION: Final rule.                                     pesticide manufacturer. The following                 Protection Agency Docket Center (EPA/
                                                                                                        list of North American Industrial                     DC), (28221T), 1200 Pennsylvania Ave.
                                                SUMMARY:    This regulation amends an                   Classification System (NAICS) codes is                NW., Washington, DC 20460–0001.
                                                existing exemption from the                             not intended to be exhaustive, but rather               • Hand Delivery: To make special
                                                requirement of a tolerance for residues                 provides a guide to help readers                      arrangements for hand delivery or
                                                of Aureobasidium pullulans strains                      determine whether this document                       delivery of boxed information, please
                                                DSM 14940 and DSM 14941 to include                      applies to them. Potentially affected                 follow the instructions at http://
                                                residues of Aureobasidium pullulans                     entities may include:                                 www.epa.gov/dockets/contacts.html.
                                                strains DSM 14940 and DSM 14941 in                         • Crop production (NAICS code 111).                Additional instructions on commenting
                                                or on all food commodities when used                       • Animal production (NAICS code                    or visiting the docket, along with more
                                                in accordance with label directions and                 112).                                                 information about dockets generally, is
                                                good agricultural practices. Bio-ferm                      • Food manufacturing (NAICS code
                                                                                                                                                              available at http://www.epa.gov/
                                                GmbH submitted a petition to EPA                        311).
                                                                                                                                                              dockets.
                                                under the Federal Food, Drug, and                          • Pesticide manufacturing (NAICS
                                                Cosmetic Act (FFDCA), requesting an                     code 32532).                                          II. Background
                                                amendment of the exemption from the                     B. How can I get electronic access to                    An exemption from the requirement
                                                requirement of a tolerance that includes                other related information?                            of a tolerance for residues of the
                                                food commodities that are treated post-                                                                       Aureobasidium pullulans strains DSM
                                                harvest. This regulation eliminates the                   You may access a frequently updated
                                                                                                                                                              14940 and DSM 14941 in or on all food
                                                need to establish a maximum                             electronic version of 40 CFR part 180
                                                                                                                                                              commodities when applied pre-harvest
                                                permissible level for residues of                       through the Government Printing
                                                                                                                                                              and used in accordance with good
                                                Aureobasidium pullulans strains DSM                     Office’s e-CFR site at http://
                                                                                                                                                              agricultural practices was established
                                                14940 and DSM 14941 under FFDCA.                        www.ecfr.gov/cgi-bin/text-
                                                                                                                                                              and published in the Federal Register of
                                                                                                        idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                DATES: This regulation is effective                                                                           February 15, 2012 (77 FR 8731) (FRL–
                                                                                                        40tab_02.tpl.
                                                November 25, 2015. Objections and                                                                             9337–3). In the Federal Register of July
                                                requests for hearings must be received                  C. How can I file an objection or hearing             17, 2015 (80 FR 42462) (FRL–9929–13),
                                                on or before January 25, 2016, and must                 request?                                              EPA issued a document pursuant to
                                                be filed in accordance with the                           Under FFDCA section 408(g), 21                      FFDCA section 408(d)(3), 21 U.S.C.
                                                instructions provided in 40 CFR part                    U.S.C. 346a(g), any person may file an                346a(d)(3), announcing the filing of a
                                                178 (see also Unit I.C. of the                          objection to any aspect of this regulation            pesticide tolerance petition (PP 4F8342)
                                                SUPPLEMENTARY INFORMATION).
                                                                                                        and may also request a hearing on those               by bio-ferm GmbH, Technologiezentrum
                                                ADDRESSES: The docket for this action,                  objections. You must file your objection              Tulln, Technopark 1, Tulln, 3430,
                                                identified by docket identification (ID)                or request a hearing on this regulation               Austria. The petition requested that 40
                                                number EPA–HQ–OPP–2010–0099, is                         in accordance with the instructions                   CFR 180.1312 be amended by
                                                available at http://www.regulations.gov                 provided in 40 CFR part 178. To ensure                expanding the current exemption to also
                                                or at the Office of Pesticide Programs                  proper receipt by EPA, you must                       include food commodities that are
                                                Regulatory Public Docket (OPP Docket)                   identify docket ID number EPA–HQ–                     treated post-harvest. Therefore an
                                                in the Environmental Protection Agency                  OPP–2010–0099 in the subject line on                  exemption from the requirement of a
                                                Docket Center (EPA/DC), West William                    the first page of your submission. All                tolerance for residues of Aureobasidium
                                                Jefferson Clinton Bldg., Rm. 3334, 1301                 objections and requests for a hearing                 pullulans strains DSM 14940 and DSM
                                                Constitution Ave. NW., Washington, DC                   must be in writing, and must be                       14941 in or on all food commodities
                                                20460–0001. The Public Reading Room                     received by the Hearing Clerk on or                   was proposed. The Notice of Filing
                                                is open from 8:30 a.m. to 4:30 p.m.,                    before January 25, 2016. Addresses for                referenced a summary of the petition
                                                Monday through Friday, excluding legal                  mail and hand delivery of objections                  prepared by the petitioner bio-ferm
                                                holidays. The telephone number for the                  and hearing requests are provided in 40               GmbH, which is available in the docket
                                                Public Reading Room is (202) 566–1744,                  CFR 178.25(b).                                        via http://www.regulations.gov. There
                                                and the telephone number for the OPP                      In addition to filing an objection or               were no comments received in response
                                                Docket is (703) 305–5805. Please review                 hearing request with the Hearing Clerk                to the notice of filing.
                                                the visitor instructions and additional                 as described in 40 CFR part 178, please               III. Final Rule
jstallworth on DSK7TPTVN1PROD with RULES




                                                information about the docket available                  submit a copy of the filing (excluding
                                                at http://www.epa.gov/dockets.                          any Confidential Business Information                 A. EPA’s Safety Determination
                                                FOR FURTHER INFORMATION CONTACT:                        (CBI)) for inclusion in the public docket.               Section 408(c)(2)(A)(i) of FFDCA
                                                Robert McNally, Biopesticides and                       Information not marked confidential                   allows EPA to establish an exemption
                                                Pollution Prevention Division (7511P),                  pursuant to 40 CFR part 2 may be                      from the requirement for a tolerance (the
                                                Office of Pesticide Programs,                           disclosed publicly by EPA without prior               legal limit for a pesticide chemical
                                                Environmental Protection Agency, 1200                   notice. Submit the non-CBI copy of your               residue in or on a food) only if EPA


                                           VerDate Sep<11>2014   15:12 Nov 24, 2015   Jkt 238001   PO 00000   Frm 00025   Fmt 4700   Sfmt 4700   E:\FR\FM\25NOR1.SGM   25NOR1


                                                73662        Federal Register / Vol. 80, No. 227 / Wednesday, November 25, 2015 / Rules and Regulations

                                                determines that the exemption is ‘‘safe.’’              2015, document entitled ‘‘Federal Food,               ‘‘Federalism’’ (64 FR 43255, August 10,
                                                Section 408(c)(2)(A)(ii) of FFDCA                       Drug, and Cosmetic Act (FFDCA)                        1999), and Executive Order 13175,
                                                defines ‘‘safe’’ to mean that ‘‘there is a              considerations for Aureobasidium                      entitled ‘‘Consultation and Coordination
                                                reasonable certainty that no harm will                  pullulans strains DSM 14940 and DSM                   with Indian Tribal Governments’’ (65 FR
                                                result from aggregate exposure to the                   14941’’ and because EPA is establishing               67249, November 9, 2000), do not apply
                                                pesticide chemical residue, including                   an exemption from the requirement of a                to this action. In addition, this action
                                                all anticipated dietary exposures and all               tolerance without any numerical                       does not impose any enforceable duty or
                                                other exposures for which there is                      limitation.                                           contain any unfunded mandate as
                                                reliable information.’’ This includes                                                                         described under Title II of the Unfunded
                                                                                                        IV. Statutory and Executive Order
                                                exposure through drinking water and in                                                                        Mandates Reform Act (UMRA) (2 U.S.C.
                                                                                                        Reviews
                                                residential settings but does not include                                                                     1501 et seq.).
                                                occupational exposure. Pursuant to                         This action establishes a tolerance
                                                                                                        exemption under FFDCA section 408(d)                     This action does not involve any
                                                FFDCA section 408(c)(2)(B), in                                                                                technical standards that would require
                                                establishing or maintaining in effect an                in response to a petition submitted to
                                                                                                        EPA. The Office of Management and                     EPA’s consideration of voluntary
                                                exemption from the requirement of a                                                                           consensus standards pursuant to section
                                                tolerance, EPA must take into account                   Budget (OMB) has exempted these types
                                                                                                        of actions from review under Executive                12(d) of the National Technology
                                                the factors set forth in FFDCA section                                                                        Transfer and Advancement Act
                                                408(b)(2)(C), which require EPA to give                 Order 12866, entitled ‘‘Regulatory
                                                                                                        Planning and Review’’ (58 FR 51735,                   (NTTAA) (15 U.S.C. 272 note).
                                                special consideration to exposure of
                                                infants and children to the pesticide                   October 4, 1993). Because this action                 V. Congressional Review Act
                                                chemical residue in establishing a                      has been exempted from review under
                                                tolerance or tolerance exemption, and to                Executive Order 12866, this action is                   Pursuant to the Congressional Review
                                                ‘‘ensure that there is a reasonable                     not subject to Executive Order 13211,                 Act (5 U.S.C. 801 et seq.), EPA will
                                                certainty that no harm will result to                   entitled ‘‘Actions Concerning                         submit a report containing this rule and
                                                infants and children from aggregate                     Regulations That Significantly Affect                 other required information to the U.S.
                                                exposure to the pesticide chemical                      Energy Supply, Distribution, or Use’’ (66             Senate, the U.S. House of
                                                residue. . . .’’ Additionally, FFDCA                    FR 28355, May 22, 2001), or Executive                 Representatives, and the Comptroller
                                                section 408(b)(2)(D) requires that EPA                  Order 13045, entitled ‘‘Protection of                 General of the United States prior to
                                                consider ‘‘available information                        Children from Environmental Health                    publication of the rule in the Federal
                                                concerning the cumulative effects of a                  Risks and Safety Risks’’ (62 FR 19885,                Register. This action is not a ‘‘major
                                                particular pesticide’s residues’’ and                   April 23, 1997). This action does not                 rule’’ as defined by 5 U.S.C. 804(2).
                                                ‘‘other substances that have a common                   contain any information collections                   List of Subjects in 40 CFR Part 180
                                                mechanism of toxicity.’’                                subject to OMB approval under the
                                                   EPA evaluated the available toxicity                 Paperwork Reduction Act (PRA), 44                       Environmental protection,
                                                and exposure data on Aureobasidium                      U.S.C. 3501 et seq., nor does it require              Administrative practice and procedure,
                                                pullulans strains DSM 14940 and DSM                     any special considerations under                      Agricultural commodities, Pesticides
                                                14941 and considered its validity,                      Executive Order 12898, entitled                       and pests, Reporting and recordkeeping
                                                completeness, and reliability, as well as               ‘‘Federal Actions to Address                          requirements.
                                                the relationship of this information to                 Environmental Justice in Minority
                                                                                                                                                                Dated: November 5, 2015.
                                                human risk. A full explanation of the                   Populations and Low-Income
                                                                                                                                                              Robert McNally,
                                                data upon which EPA relied and its risk                 Populations’’ (59 FR 7629, February 16,
                                                assessment based on that data can be                    1994).                                                Director, Biopesticides and Pollution
                                                                                                           Since tolerances and exemptions that               Prevention Division, Office of Pesticide
                                                found within the October 15, 2015,                                                                            Programs.
                                                document entitled ‘‘Federal Food, Drug,                 are established on the basis of a petition
                                                and Cosmetic Act (FFDCA)                                under FFDCA section 408(d), such as                     Therefore, 40 CFR chapter I is
                                                considerations for Aureobasidium                        the tolerance exemption in this action,               amended as follows:
                                                pullulans strains DSM 14940 and DSM                     do not require the issuance of a
                                                14941’’. This document, as well as other                proposed rule, the requirements of the                PART 180—[AMENDED]
                                                relevant information, is available in the               Regulatory Flexibility Act (RFA) (5
                                                docket for this action as described under               U.S.C. 601 et seq.) do not apply.                     ■ 1. The authority citation for part 180
                                                ADDRESSES. Based upon its evaluation,                      This action directly regulates growers,            continues to read as follows:
                                                EPA concludes that there is a reasonable                food processors, food handlers, and food
                                                                                                                                                                  Authority: 21 U.S.C. 321(q), 346a and 371.
                                                certainty that no harm will result to the               retailers, not States or tribes. As a result,
                                                U.S. population, including infants and                  this action does not alter the                        ■ 2. Revise § 180.1312 to read as
                                                children, from aggregate exposure to                    relationships or distribution of power                follows:
                                                residues of Aureobasidium pullulans                     and responsibilities established by
                                                strains DSM 14940 and DSM 14941.                        Congress in the preemption provisions                 § 180.1312 Aureobasidium pullulans
                                                                                                        of FFDCA section 408(n)(4). As such,                  strains DSM 14940 and DSM 14941;
                                                Therefore, an exemption from the                                                                              exemption from the requirement of a
                                                requirement of a tolerance is established               EPA has determined that this action will
                                                                                                                                                              tolerance.
                                                for residues of Aureobasidium pullulans                 not have a substantial direct effect on
                                                strains DSM 14940 and DSM 14941 in                      States or tribal governments, on the                    An exemption from the requirement
                                                or on all food commodities when used                    relationship between the national                     of a tolerance is established for residues
jstallworth on DSK7TPTVN1PROD with RULES




                                                in accordance with label directions and                 government and the States or tribal                   of Aureobasidium pullulans strains
                                                good agricultural practices.                            governments, or on the distribution of                DSM 14940 and DSM 14941 in or on all
                                                                                                        power and responsibilities among the                  food commodities when used in
                                                B. Analytical Enforcement Methodology                   various levels of government or between               accordance with label directions and
                                                  An analytical method is not required                  the Federal Government and Indian                     good agricultural practices.
                                                for enforcement purposes for the                        tribes. Thus, EPA has determined that                 [FR Doc. 2015–29888 Filed 11–24–15; 8:45 am]
                                                reasons contained in the October 15,                    Executive Order 13132, entitled                       BILLING CODE 6560–50–P




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Document Created: 2018-03-01 11:14:17
Document Modified: 2018-03-01 11:14:17
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 November 25, 2015. Objections and requests for hearings must be received on or before January 25, 2016, 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 Citation80 FR 73661 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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