Bacillus Mycoides Isolate J; Exemption From the Requirement of a Tolerance, 67920-67922 [2016-23608]

Download as PDF 67920 Federal Register / Vol. 81, No. 191 / Monday, October 3, 2016 / Rules and Regulations Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 2, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today’s Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that the EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).) § 62.12611 Identification of sources. The plan applies to each individual hospital/medical/infectious waste incinerator: (a) For which construction was commenced on or before June 20, 1996, or for which modification was commenced on or before March 16, 1998. (b) For which construction was commenced after June 20, 1996 but no later than December 1, 2008, or for which modification is commenced after March 16, 1998 but no later than April 6, 2010. ■ 4. Section 62.12612 is revised to read as follows: § 62.12612 Effective date. The effective date of the plan for hospital/medical/infectious waste incinerators is December 2, 2016. Editorial Note: This document was received for publication by the Office of the Federal Register on September 26, 2016. [FR Doc. 2016–23584 Filed 9–30–16; 8:45 am] BILLING CODE 6560–50–P List of Subjects in 40 CFR Part 62 I. General Information Environmental protection, Air pollution control, Solid waste incineration, Hospital/medical/ infectious waste incineration. ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 Authority: 42 U.S.C. 7401 et seq. [EPA–HQ–OPP–2014–0920; FRL–9947–92] Dated: May 17, 2016. Shaun L. McGrath, Regional Administrator, Region 8. Bacillus Mycoides Isolate J; Exemption From the Requirement of a Tolerance Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: 40 CFR part 62, subpart ZZ, is amended as follows: PART 62—APPROVAL AND PROMULGATION OF STATE PLANS FOR DESIGNATED FACILITIES AND POLLUTANTS 1. The authority citation for part 62 continues to read as follows: Authority: 42 U.S.C. 7401 et seq. Subpart ZZ—Wyoming 2. Section 62.12610 is revised to read as follows: ■ rmajette on DSK2TPTVN1PROD with RULES Identification of plan. Section 111(d)/129 Plan for Hospital/ Medical/Infectious Waste Incinerators and the associated State regulation, Chapter 4, Section 5, and Chapter 5 of the Wyoming Air Quality Standards and Regulations, submitted by the State on September 7, 1999 and November 9, 1999, and as amended on May 13, 2015 and November 24, 2015. 3. Section 62.12611 is revised to read as follows: ■ VerDate Sep<11>2014 16:23 Sep 30, 2016 Jkt 241001 This regulation establishes an exemption from the requirement of a tolerance for residues of Bacillus mycoides isolate 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 SUMMARY: ■ § 62.12610 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: BPPDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 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/textidx?&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 E:\FR\FM\03OCR1.SGM 03OCR1 Federal Register / Vol. 81, No. 191 / Monday, October 3, 2016 / Rules and Regulations rmajette on DSK2TPTVN1PROD with RULES 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. VerDate Sep<11>2014 14:33 Sep 30, 2016 Jkt 241001 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 PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 67921 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, E:\FR\FM\03OCR1.SGM 03OCR1 67922 Federal Register / Vol. 81, No. 191 / Monday, October 3, 2016 / Rules and Regulations 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] 1. The authority citation for part 180 continues to read as follows: ■ Authority: 21 U.S.C. 321(q), 346a and 371. 2. Revise § 180.1269 to read as follows: rmajette on DSK2TPTVN1PROD with RULES ■ § 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 VerDate Sep<11>2014 17:43 Sep 30, 2016 Jkt 241001 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 FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [WC Docket Nos. 11–42, 09–197 and 10– 90; FCC 16–38] Lifeline and Link Up Reform and Modernization, Telecommunications Carriers Eligible for Universal Service Support, Connect America Fund Federal Communications Commission. ACTION: Final rule; announcement of effective date. AGENCY: In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved, for a period of three years, the information collection requirements associated with certain of the provision of the rules adopted as part of the Commission’s Third Further Notice of Proposed Rulemaking, Order on Reconsideration, and Further Report and Order, (Lifeline Third Reform Order). This notice is consistent with the Lifeline Third Reform Order, which stated that the Commission would publish a document in the Federal Register announcing OMB approval and the effective date of those rules. DATES: The rule amendments to 47 CFR 54.202(a)(6), (d), and (e), and 54.205(c) published at 81 FR 33025, May 24, 2016, will become effective October 3, 2016. The rule amendments to 47 CFR 54.101, 54.401(a)(2), (b), (c), (f), 54.403(a), 54.405(e)(1), (e)(3) through (e)(5), 54.407(a), (c)(2), (d), 54.408, 54.409(a)(2), 54.410(b) through (e), (g) through (h), 54.411, 54.416(a)(3), 54.420(b), and 54.422(b)(3) will become effective December 2, 2016 . The rule amendments to 47 CFR 54.410(f) will become effective January 1, 2017. The rule amendments to 47 CFR 54.400(l) are applicable October 3, 2016. The rule amendments to 47 CFR 54.400(f), (j), and (m) through (o) are applicable December 2, 2016. FOR FURTHER INFORMATION CONTACT: Christian Hoefly, Wireline Competition Bureau, Telecommunications Access Policy Division at (202) 418–3607 or at christian.hoefly@fcc.gov. SUPPLEMENTARY INFORMATION: This document announces that, on SUMMARY: PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 September 20, 2016, OMB approved, for a period of three years, the information collection requirements contained in the Commission’s Order, FCC 16–38, published at 81 FR 33025, May 24, 2016. The OMB Control Number is 3060–0819. The Commission publishes this notice as an announcement of the effective date rules requiring OMB approval. If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Nicole Ongele, Federal Communications Commission, Room 1–A620, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060–0819, in your correspondence. The Commission will also accept your comments via email at PRA@fcc.gov. To request material in accessible formation for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@ fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418–0530 (voice), (202) 418–0432 (TTY). Synopsis As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on September 20, 2016, for the information collection requirements contained in the Commission’s rules in 47 CFR part 54. Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060–0819. The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104–13, October 1, 1995, and 44 U.S.C. 3507. The total annual reporting burdens and costs for the respondents are as follows: OMB Control Number: 3060–0819. OMB Approval Date: 9/20/2016. OMB Expiration Date: 9/30/2019. Title: Lifeline and Link Up Reform and Modernization, Telecommunications Carriers Eligible for Universal Service Support, Connect America Fund. Form Number: FCC Forms 497, 481 & 555. Type of Review: Revision of a currently approved collection. E:\FR\FM\03OCR1.SGM 03OCR1

Agencies

[Federal Register Volume 81, Number 191 (Monday, October 3, 2016)]
[Rules and Regulations]
[Pages 67920-67922]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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: BPPDFRNotices@epa.gov.

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]

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

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


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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