81_FR_68111 81 FR 67920 - Bacillus Mycoides Isolate J; Exemption From the Requirement of a Tolerance

81 FR 67920 - Bacillus Mycoides Isolate J; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 191 (October 3, 2016)

Page Range67920-67922
FR Document2016-23608

This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus mycoides solate J in or on all agricultural commodities when used in accordance with label directions and good agricultural practices. Certis USA LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of Bacillus mycoides isolate J under FFDCA.

Federal Register, Volume 81 Issue 191 (Monday, October 3, 2016)
[Federal Register Volume 81, Number 191 (Monday, October 3, 2016)]
[Rules and Regulations]
[Pages 67920-67922]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-23608]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0920; FRL-9947-92]


Bacillus Mycoides Isolate J; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of Bacillus mycoides solate J in or on all 
agricultural commodities when used in accordance with label directions 
and good agricultural practices. Certis USA LLC submitted a petition to 
EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
an exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of Bacillus mycoides isolate J under FFDCA.

DATES: This regulation is effective October 3, 2016. Objections and 
requests for hearings must be received on or before December 2, 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-2014-0920, 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

[[Page 67921]]

provided in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket ID number EPA-HQ-OPP-2014-0920 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 December 2, 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-2014-0920, 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 January 28, 2015 (80 FR 4525) (FRL-9921-
55), 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 4F8252) by Certis USA LLC, 9145 Guilford Rd., Suite 175, 
Columbia, MD 21046. The petition requested that 40 CFR part 180 be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of Bacillus mycoides isolate J, in or on all 
agricultural commodities. That document referenced a summary of the 
petition prepared by the petitioner Certis USA LLC, which is available 
in the docket via http://www.regulations.gov. There were no comments 
received in response to the notice of filing.
    In addition, the Agency is removing the existing paragraph 
contained in section 180.1269 because that exemption from the 
requirement of a tolerance for Bacillus mycoides isolate J residues has 
expired.

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 
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 Bacillus 
mycoides isolate J 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 May 9, 2016, 
document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) 
Considerations for Bacillus mycoides isolate J.'' 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 Bacillus mycoides isolate J. Therefore, an 
exemption from the requirement of a tolerance is established for 
residues of Bacillus mycoides isolate J in or on all agricultural 
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 May 9, 2016, document entitled ``Federal 
Food, Drug, and Cosmetic Act (FFDCA) Considerations for Bacillus 
mycoides isolate J'' 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,

[[Page 67922]]

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: September 15, 2016.
Yu-Ting Guilaran,
Acting Director, 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.  180.1269 to read as follows:


Sec.  180.1269  Bacillus mycoides isolate J; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Bacillus mycoides isolate J in or on all agricultural 
commodities when used in accordance with label directions and good 
agricultural practices.

[FR Doc. 2016-23608 Filed 9-30-16; 8:45 am]
 BILLING CODE 6560-50-P



                                             67920               Federal Register / Vol. 81, No. 191 / Monday, October 3, 2016 / Rules and Regulations

                                               Under section 307(b)(1) of the Clean                    § 62.12611    Identification of sources.              available at http://www.regulations.gov
                                             Air Act, petitions for judicial review of                    The plan applies to each individual                or at the Office of Pesticide Programs
                                             this action must be filed in the United                   hospital/medical/infectious waste                     Regulatory Public Docket (OPP Docket)
                                             States Court of Appeals for the                           incinerator:                                          in the Environmental Protection Agency
                                             appropriate circuit by December 2,                           (a) For which construction was                     Docket Center (EPA/DC), West William
                                             2016. Filing a petition for                               commenced on or before June 20, 1996,                 Jefferson Clinton Bldg., Rm. 3334, 1301
                                             reconsideration by the Administrator of                   or for which modification was                         Constitution Ave. NW., Washington, DC
                                             this final rule does not affect the finality              commenced on or before March 16,                      20460–0001. The Public Reading Room
                                             of this action for the purposes of judicial               1998.                                                 is open from 8:30 a.m. to 4:30 p.m.,
                                             review nor does it extend the time                           (b) For which construction was                     Monday through Friday, excluding legal
                                             within which a petition for judicial                      commenced after June 20, 1996 but no                  holidays. The telephone number for the
                                             review may be filed, and shall not                        later than December 1, 2008, or for                   Public Reading Room is (202) 566–1744,
                                             postpone the effectiveness of such rule                   which modification is commenced after                 and the telephone number for the OPP
                                             or action. Parties with objections to this                March 16, 1998 but no later than April                Docket is (703) 305–5805. Please review
                                             direct final rule are encouraged to file a                6, 2010.                                              the visitor instructions and additional
                                             comment in response to the parallel                       ■ 4. Section 62.12612 is revised to read              information about the docket available
                                             notice of proposed rulemaking for this                    as follows:                                           at http://www.epa.gov/dockets.
                                             action published in the proposed rules                                                                          FOR FURTHER INFORMATION CONTACT:
                                             section of today’s Federal Register,                      § 62.12612    Effective date.                         Robert McNally, Biopesticides and
                                             rather than file an immediate petition                      The effective date of the plan for                  Pollution Prevention Division (7511P),
                                             for judicial review of this direct final                  hospital/medical/infectious waste                     Office of Pesticide Programs,
                                             rule, so that the EPA can withdraw this                   incinerators is December 2, 2016.                     Environmental Protection Agency, 1200
                                             direct final rule and address the                           Editorial Note: This document was                   Pennsylvania Ave. NW., Washington,
                                             comment in the proposed rulemaking.                       received for publication by the Office of the         DC 20460–0001; main telephone
                                             This action may not be challenged later                   Federal Register on September 26, 2016.               number: (703) 305–7090; email address:
                                             in proceedings to enforce its                             [FR Doc. 2016–23584 Filed 9–30–16; 8:45 am]           BPPDFRNotices@epa.gov.
                                             requirements. (See section 307(b)(2).)                    BILLING CODE 6560–50–P                                SUPPLEMENTARY INFORMATION:
                                             List of Subjects in 40 CFR Part 62                                                                              I. General Information
                                               Environmental protection, Air                           ENVIRONMENTAL PROTECTION                              A. Does this action apply to me?
                                             pollution control, Solid waste                            AGENCY                                                   You may be potentially affected by
                                             incineration, Hospital/medical/
                                                                                                       40 CFR Part 180                                       this action if you are an agricultural
                                             infectious waste incineration.
                                                                                                                                                             producer, food manufacturer, or
                                                 Authority: 42 U.S.C. 7401 et seq.                     [EPA–HQ–OPP–2014–0920; FRL–9947–92]                   pesticide manufacturer. The following
                                               Dated: May 17, 2016.                                                                                          list of North American Industrial
                                                                                                       Bacillus Mycoides Isolate J; Exemption                Classification System (NAICS) codes is
                                             Shaun L. McGrath,                                         From the Requirement of a Tolerance
                                             Regional Administrator, Region 8.                                                                               not intended to be exhaustive, but rather
                                                                                                       AGENCY:  Environmental Protection                     provides a guide to help readers
                                               40 CFR part 62, subpart ZZ, is                          Agency (EPA).                                         determine whether this document
                                             amended as follows:                                                                                             applies to them. Potentially affected
                                                                                                       ACTION: Final rule.
                                                                                                                                                             entities may include:
                                             PART 62—APPROVAL AND                                      SUMMARY:   This regulation establishes an                • Crop production (NAICS code 111).
                                             PROMULGATION OF STATE PLANS                               exemption from the requirement of a                      • Animal production (NAICS code
                                             FOR DESIGNATED FACILITIES AND                             tolerance for residues of Bacillus                    112).
                                             POLLUTANTS                                                mycoides isolate J in or on all                          • Food manufacturing (NAICS code
                                                                                                       agricultural commodities when used in                 311).
                                             ■ 1. The authority citation for part 62                   accordance with label directions and                     • Pesticide manufacturing (NAICS
                                             continues to read as follows:                             good agricultural practices. Certis USA               code 32532).
                                                 Authority: 42 U.S.C. 7401 et seq.                     LLC submitted a petition to EPA under                 B. How can I get electronic access to
                                                                                                       the Federal Food, Drug, and Cosmetic                  other related information?
                                             Subpart ZZ—Wyoming                                        Act (FFDCA), requesting an exemption
                                                                                                                                                               You may access a frequently updated
                                                                                                       from the requirement of a tolerance.
                                             ■ 2. Section 62.12610 is revised to read                                                                        electronic version of 40 CFR part 180
                                                                                                       This regulation eliminates the need to
                                             as follows:                                                                                                     through the Government Printing
                                                                                                       establish a maximum permissible level
                                                                                                                                                             Office’s e-CFR site at http://
                                             § 62.12610       Identification of plan.
                                                                                                       for residues of Bacillus mycoides isolate
                                                                                                                                                             www.ecfr.gov/cgi-bin/text-
                                                                                                       J under FFDCA.
                                               Section 111(d)/129 Plan for Hospital/                                                                         idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
                                                                                                       DATES: This regulation is effective                   40tab_02.tpl.
                                             Medical/Infectious Waste Incinerators                     October 3, 2016. Objections and
                                             and the associated State regulation,                      requests for hearings must be received                C. How can I file an objection or hearing
                                             Chapter 4, Section 5, and Chapter 5 of                    on or before December 2, 2016, and                    request?
                                             the Wyoming Air Quality Standards and                     must be filed in accordance with the                    Under FFDCA section 408(g), 21
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                                             Regulations, submitted by the State on                    instructions provided in 40 CFR part                  U.S.C. 346a(g), any person may file an
                                             September 7, 1999 and November 9,                         178 (see also Unit I.C. of the                        objection to any aspect of this regulation
                                             1999, and as amended on May 13, 2015                      SUPPLEMENTARY INFORMATION).                           and may also request a hearing on those
                                             and November 24, 2015.
                                                                                                       ADDRESSES: The docket for this action,                objections. You must file your objection
                                             ■ 3. Section 62.12611 is revised to read                  identified by docket identification (ID)              or request a hearing on this regulation
                                             as follows:                                               number EPA–HQ–OPP–2014–0920, is                       in accordance with the instructions


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                                                               Federal Register / Vol. 81, No. 191 / Monday, October 3, 2016 / Rules and Regulations                                           67921

                                             provided in 40 CFR part 178. To ensure                    In addition, the Agency is removing                 mycoides isolate J. Therefore, an
                                             proper receipt by EPA, you must                         the existing paragraph contained in                   exemption from the requirement of a
                                             identify docket ID number EPA–HQ–                       section 180.1269 because that                         tolerance is established for residues of
                                             OPP–2014–0920 in the subject line on                    exemption from the requirement of a                   Bacillus mycoides isolate J in or on all
                                             the first page of your submission. All                  tolerance for Bacillus mycoides isolate J             agricultural commodities when used in
                                             objections and requests for a hearing                   residues has expired.                                 accordance with label directions and
                                             must be in writing, and must be                                                                               good agricultural practices.
                                                                                                     III. Final Rule
                                             received by the Hearing Clerk on or
                                                                                                                                                           B. Analytical Enforcement Methodology
                                             before December 2, 2016. Addresses for                  A. EPA’s Safety Determination
                                             mail and hand delivery of objections                                                                            An analytical method is not required
                                                                                                        Section 408(c)(2)(A)(i) of FFDCA
                                             and hearing requests are provided in 40                                                                       for enforcement purposes for the
                                                                                                     allows EPA to establish an exemption                  reasons contained in the May 9, 2016,
                                             CFR 178.25(b).                                          from the requirement for a tolerance (the
                                               In addition to filing an objection or                                                                       document entitled ‘‘Federal Food, Drug,
                                                                                                     legal limit for a pesticide chemical                  and Cosmetic Act (FFDCA)
                                             hearing request with the Hearing Clerk
                                                                                                     residue in or on a food) only if EPA                  Considerations for Bacillus mycoides
                                             as described in 40 CFR part 178, please
                                                                                                     determines that the exemption is ‘‘safe.’’            isolate J’’ and because EPA is
                                             submit a copy of the filing (excluding
                                                                                                     Section 408(c)(2)(A)(ii) of FFDCA                     establishing an exemption from the
                                             any Confidential Business Information
                                                                                                     defines ‘‘safe’’ to mean that ‘‘there is a            requirement of a tolerance without any
                                             (CBI)) for inclusion in the public docket.
                                                                                                     reasonable certainty that no harm will                numerical limitation.
                                             Information not marked confidential
                                                                                                     result from aggregate exposure to the
                                             pursuant to 40 CFR part 2 may be                                                                              IV. Statutory and Executive Order
                                                                                                     pesticide chemical residue, including
                                             disclosed publicly by EPA without prior                                                                       Reviews
                                             notice. Submit the non-CBI copy of your                 all anticipated dietary exposures and all
                                             objection or hearing request, identified                other exposures for which there is                       This action establishes a tolerance
                                             by docket ID number EPA–HQ–OPP–                         reliable information.’’ This includes                 exemption under FFDCA section 408(d)
                                             2014–0920, by one of the following                      exposure through drinking water and in                in response to a petition submitted to
                                             methods:                                                residential settings but does not include             EPA. The Office of Management and
                                               • Federal eRulemaking Portal: http://                 occupational exposure. Pursuant to                    Budget (OMB) has exempted these types
                                             www.regulations.gov. Follow the online                  FFDCA section 408(c)(2)(B), in                        of actions from review under Executive
                                             instructions for submitting comments.                   establishing or maintaining in effect an              Order 12866, entitled ‘‘Regulatory
                                             Do not submit electronically any                        exemption from the requirement of a                   Planning and Review’’ (58 FR 51735,
                                             information you consider to be CBI or                   tolerance, EPA must take into account                 October 4, 1993). Because this action
                                             other information whose disclosure is                   the factors set forth in FFDCA section                has been exempted from review under
                                             restricted by statute.                                  408(b)(2)(C), which require EPA to give               Executive Order 12866, this action is
                                               • Mail: OPP Docket, Environmental                     special consideration to exposure of                  not subject to Executive Order 13211,
                                             Protection Agency Docket Center (EPA/                   infants and children to the pesticide                 entitled ‘‘Actions Concerning
                                             DC), (28221T), 1200 Pennsylvania Ave.                   chemical residue in establishing a                    Regulations That Significantly Affect
                                             NW., Washington, DC 20460–0001.                         tolerance or tolerance exemption, and to              Energy Supply, Distribution, or Use’’ (66
                                               • Hand Delivery: To make special                      ‘‘ensure that there is a reasonable                   FR 28355, May 22, 2001), or Executive
                                             arrangements for hand delivery or                       certainty that no harm will result to                 Order 13045, entitled ‘‘Protection of
                                             delivery of boxed information, please                   infants and children from aggregate                   Children from Environmental Health
                                             follow the instructions at http://                      exposure to the pesticide chemical                    Risks and Safety Risks’’ (62 FR 19885,
                                             www.epa.gov/dockets/contacts.html.                      residue . . . .’’ Additionally, FFDCA                 April 23, 1997). This action does not
                                             Additional instructions on commenting                   section 408(b)(2)(D) requires that EPA                contain any information collections
                                             or visiting the docket, along with more                 consider ‘‘available information                      subject to OMB approval under the
                                             information about dockets generally, is                 concerning the cumulative effects of [a               Paperwork Reduction Act (PRA), 44
                                             available at http://www.epa.gov/                        particular pesticide’s] . . . residues and            U.S.C. 3501 et seq., nor does it require
                                             dockets.                                                other substances that have a common                   any special considerations under
                                                                                                     mechanism of toxicity.’’                              Executive Order 12898, entitled
                                             II. Background                                             EPA evaluated the available toxicity               ‘‘Federal Actions to Address
                                                In the Federal Register of January 28,               and exposure data on Bacillus mycoides                Environmental Justice in Minority
                                             2015 (80 FR 4525) (FRL–9921–55), EPA                    isolate J and considered its validity,                Populations and Low-Income
                                             issued a document pursuant to FFDCA                     completeness, and reliability, as well as             Populations’’ (59 FR 7629, February 16,
                                             section 408(d)(3), 21 U.S.C. 346a(d)(3),                the relationship of this information to               1994).
                                             announcing the filing of a pesticide                    human risk. A full explanation of the                    Since tolerances and exemptions that
                                             tolerance petition (PP 4F8252) by Certis                data upon which EPA relied and its risk               are established on the basis of a petition
                                             USA LLC, 9145 Guilford Rd., Suite 175,                  assessment based on that data can be                  under FFDCA section 408(d), such as
                                             Columbia, MD 21046. The petition                        found within the May 9, 2016,                         the tolerance exemption in this action,
                                             requested that 40 CFR part 180 be                       document entitled ‘‘Federal Food, Drug,               do not require the issuance of a
                                             amended by establishing an exemption                    and Cosmetic Act (FFDCA)                              proposed rule, the requirements of the
                                             from the requirement of a tolerance for                 Considerations for Bacillus mycoides                  Regulatory Flexibility Act (RFA) (5
                                             residues of Bacillus mycoides isolate J,                isolate J.’’ This document, as well as                U.S.C. 601 et seq.) do not apply.
                                             in or on all agricultural commodities.                  other relevant information, is available                 This action directly regulates growers,
                                             That document referenced a summary of                   in the docket for this action as described            food processors, food handlers, and food
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                                             the petition prepared by the petitioner                 under ADDRESSES. Based upon its                       retailers, not States or tribes. As a result,
                                             Certis USA LLC, which is available in                   evaluation, EPA concludes that there is               this action does not alter the
                                             the docket via http://                                  a reasonable certainty that no harm will              relationships or distribution of power
                                             www.regulations.gov. There were no                      result to the U.S. population, including              and responsibilities established by
                                             comments received in response to the                    infants and children, from aggregate                  Congress in the preemption provisions
                                             notice of filing.                                       exposure to residues of Bacillus                      of FFDCA section 408(n)(4). As such,


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                                             67922             Federal Register / Vol. 81, No. 191 / Monday, October 3, 2016 / Rules and Regulations

                                             EPA has determined that this action will                all agricultural commodities when used                September 20, 2016, OMB approved, for
                                             not have a substantial direct effect on                 in accordance with label directions and               a period of three years, the information
                                             States or tribal governments, on the                    good agricultural practices.                          collection requirements contained in the
                                             relationship between the national                       [FR Doc. 2016–23608 Filed 9–30–16; 8:45 am]           Commission’s Order, FCC 16–38,
                                             government and the States or tribal                     BILLING CODE 6560–50–P
                                                                                                                                                           published at 81 FR 33025, May 24,
                                             governments, or on the distribution of                                                                        2016. The OMB Control Number is
                                             power and responsibilities among the                                                                          3060–0819. The Commission publishes
                                             various levels of government or between                 FEDERAL COMMUNICATIONS                                this notice as an announcement of the
                                             the Federal Government and Indian                       COMMISSION                                            effective date rules requiring OMB
                                             tribes. Thus, EPA has determined that                                                                         approval. If you have any comments on
                                             Executive Order 13132, entitled                         47 CFR Part 54                                        the burden estimates listed below, or
                                             ‘‘Federalism’’ (64 FR 43255, August 10,                                                                       how the Commission can improve the
                                             1999), and Executive Order 13175,                       [WC Docket Nos. 11–42, 09–197 and 10–                 collections and reduce any burdens
                                                                                                     90; FCC 16–38]
                                             entitled ‘‘Consultation and Coordination                                                                      caused thereby, please contact Nicole
                                             with Indian Tribal Governments’’ (65 FR                 Lifeline and Link Up Reform and                       Ongele, Federal Communications
                                             67249, November 9, 2000), do not apply                  Modernization, Telecommunications                     Commission, Room 1–A620, 445 12th
                                             to this action. In addition, this action                Carriers Eligible for Universal Service               Street SW., Washington, DC 20554.
                                             does not impose any enforceable duty or                 Support, Connect America Fund                         Please include the OMB Control
                                             contain any unfunded mandate as                                                                               Number, 3060–0819, in your
                                             described under Title II of the Unfunded                AGENCY:   Federal Communications                      correspondence. The Commission will
                                             Mandates Reform Act (UMRA) (2 U.S.C.                    Commission.                                           also accept your comments via email at
                                             1501 et seq.).                                          ACTION: Final rule; announcement of                   PRA@fcc.gov.
                                                This action does not involve any                     effective date.                                          To request material in accessible
                                             technical standards that would require                                                                        formation for people with disabilities
                                             EPA’s consideration of voluntary                        SUMMARY:    In this document, the Federal             (Braille, large print, electronic files,
                                             consensus standards pursuant to section                 Communications Commission                             audio format), send an email to fcc504@
                                             12(d) of the National Technology                        (Commission) announces that the Office                fcc.gov or call the Consumer and
                                             Transfer and Advancement Act                            of Management and Budget (OMB) has                    Governmental Affairs Bureau at (202)
                                             (NTTAA) (15 U.S.C. 272 note).                           approved, for a period of three years, the            418–0530 (voice), (202) 418–0432
                                                                                                     information collection requirements                   (TTY).
                                             V. Congressional Review Act                             associated with certain of the provision
                                               Pursuant to the Congressional Review                  of the rules adopted as part of the                   Synopsis
                                             Act (5 U.S.C. 801 et seq.), EPA will                    Commission’s Third Further Notice of                    As required by the Paperwork
                                             submit a report containing this rule and                Proposed Rulemaking, Order on                         Reduction Act of 1995 (44 U.S.C. 3507),
                                             other required information to the U.S.                  Reconsideration, and Further Report                   the FCC is notifying the public that it
                                             Senate, the U.S. House of                               and Order, (Lifeline Third Reform                     received OMB approval on September
                                             Representatives, and the Comptroller                    Order). This notice is consistent with                20, 2016, for the information collection
                                             General of the United States prior to                   the Lifeline Third Reform Order, which                requirements contained in the
                                             publication of the rule in the Federal                  stated that the Commission would                      Commission’s rules in 47 CFR part 54.
                                             Register. This action is not a ‘‘major                  publish a document in the Federal                       Under 5 CFR part 1320, an agency
                                             rule’’ as defined by 5 U.S.C. 804(2).                   Register announcing OMB approval and                  may not conduct or sponsor a collection
                                                                                                     the effective date of those rules.                    of information unless it displays a
                                             List of Subjects in 40 CFR Part 180                                                                           current, valid OMB Control Number.
                                                                                                     DATES: The rule amendments to 47 CFR
                                               Environmental protection,                             54.202(a)(6), (d), and (e), and 54.205(c)               No person shall be subject to any
                                             Administrative practice and procedure,                  published at 81 FR 33025, May 24,                     penalty for failing to comply with a
                                             Agricultural commodities, Pesticides                    2016, will become effective October 3,                collection of information subject to the
                                             and pests, Reporting and recordkeeping                  2016. The rule amendments to 47 CFR                   Paperwork Reduction Act that does not
                                             requirements.                                           54.101, 54.401(a)(2), (b), (c), (f),                  display a current, valid OMB Control
                                              Dated: September 15, 2016.                             54.403(a), 54.405(e)(1), (e)(3) through               Number. The OMB Control Number is
                                             Yu-Ting Guilaran,                                       (e)(5), 54.407(a), (c)(2), (d), 54.408,               3060–0819.
                                                                                                     54.409(a)(2), 54.410(b) through (e), (g)                The foregoing notice is required by
                                             Acting Director, Office of Pesticide Programs.
                                                                                                     through (h), 54.411, 54.416(a)(3),                    the Paperwork Reduction Act of 1995,
                                               Therefore, 40 CFR chapter I is                                                                              Public Law 104–13, October 1, 1995,
                                                                                                     54.420(b), and 54.422(b)(3) will become
                                             amended as follows:                                                                                           and 44 U.S.C. 3507.
                                                                                                     effective December 2, 2016 . The rule
                                                                                                     amendments to 47 CFR 54.410(f) will                     The total annual reporting burdens
                                             PART 180—[AMENDED]                                                                                            and costs for the respondents are as
                                                                                                     become effective January 1, 2017.
                                             ■ 1. The authority citation for part 180                   The rule amendments to 47 CFR                      follows:
                                                                                                     54.400(l) are applicable October 3, 2016.               OMB Control Number: 3060–0819.
                                             continues to read as follows:                                                                                   OMB Approval Date: 9/20/2016.
                                                                                                     The rule amendments to 47 CFR
                                                 Authority: 21 U.S.C. 321(q), 346a and 371.                                                                  OMB Expiration Date: 9/30/2019.
                                                                                                     54.400(f), (j), and (m) through (o) are                 Title: Lifeline and Link Up Reform
                                             ■ 2. Revise § 180.1269 to read as                       applicable December 2, 2016.
                                             follows:                                                                                                      and Modernization,
                                                                                                     FOR FURTHER INFORMATION CONTACT:
rmajette on DSK2TPTVN1PROD with RULES




                                                                                                                                                           Telecommunications Carriers Eligible
                                             § 180.1269 Bacillus mycoides isolate J;                 Christian Hoefly, Wireline Competition                for Universal Service Support, Connect
                                             exemption from the requirement of a                     Bureau, Telecommunications Access                     America Fund.
                                             tolerance.                                              Policy Division at (202) 418–3607 or at                 Form Number: FCC Forms 497, 481 &
                                               An exemption from the requirement                     christian.hoefly@fcc.gov.                             555.
                                             of a tolerance is established for residues              SUPPLEMENTARY INFORMATION: This                         Type of Review: Revision of a
                                             of Bacillus mycoides isolate J in or on                 document announces that, on                           currently approved collection.


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Document Created: 2018-02-13 14:11:05
Document Modified: 2018-02-13 14:11:05
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 October 3, 2016. Objections and requests for hearings must be received on or before December 2, 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 Citation81 FR 67920 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

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