Spodoptera frugiperda, 83704-83706 [2016-28099]

Download as PDF sradovich on DSK3GMQ082PROD with RULES 83704 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Rules and Regulations observers, including an ability to differentiate coke oven emissions from condensing water vapor and smoldering coal. The composition of the panel must be approved by the Administrator as part of the training course approval process. The panel members will be EPA, state or local agency personnel, or industry contractors listed in 59 FR 11960 (March 15, 1994) or qualified as part of the training provider approval process of section 10.1 of this method. Each panel member shall have at least 120 days experience in reading visible emissions from coke ovens. The visible emissions inspections that will satisfy the experience requirement must be inspections of coke oven battery fugitive emissions from the emission points subject to emission standards under subpart L of this part (i.e., coke oven doors, topside port lids, offtake system(s), and charging operations), using either Method 303 or predecessor state or local test methods. A ‘‘day’s experience’’ for a particular inspection is a day on which one complete inspection was performed for that emission point under Method 303 or a predecessor state or local method. A ‘‘day’s experience’’ does not mean 8 or 10 hours performing inspections, or any particular time expressed in minutes or hours that may have been spent performing them. Thus, it would be possible for an individual to qualify as a Method 303 panel member for some emission points, but not others (e.g., an individual might satisfy the experience requirement for coke oven doors, but not topside port lids). Until November 15, 1994, the EPA may waive the certification requirement (but not the experience requirement) for panel members. The composition of the panel shall be approved by the EPA. The panel shall observe the trainee in a series of training runs and a series of certification runs. There shall be a minimum of 1 training run for doors, topside port lids, and offtake systems, and a minimum of 5 training runs (i.e., 5 charges) for charging. During training runs, the panel can advise the trainee on proper procedures. There shall be a minimum of 3 certification runs for doors, topside port lids, and offtake systems, and a minimum of 15 certification runs for charging (i.e., 15 charges). The certification runs shall be unassisted. Following the certification test runs, the panel shall approve or disapprove certification based on the trainee’s performance during the certification runs. To obtain certification, the trainee shall demonstrate, to the satisfaction of the panel, a high degree of proficiency in performing Method 303. To aid in evaluating the trainee’s performance, a checklist, approved by the EPA, will be used by the panel members. 10.1.4 Those successfully completing the initial certification or third-year recertification requirements shall receive a certificate showing certification as a Method 303 observer and the beginning and ending dates of the certification period. 10.1.5 The training provider will submit to the EPA or its designee the following information for each trainee successfully completing initial certification or third-year recertification training: Name, employer, VerDate Sep<11>2014 16:34 Nov 21, 2016 Jkt 241001 address, telephone, cell and/or fax numbers, email address, beginning and ending dates of certification, and whether training was for 3year certification or 1-year recertification. This information must be submitted within 30 days of the course completion. 10.1.6 The training provider will maintain the following records, to be made available to EPA or its designee on request (within 30 days of a request): (a) A file for each Method 303 observer containing the signed certification checklists, certification forms and test results for their initial certification, and any subsequent third-year recertifications. Initial certification records must also include documentation showing successful completion of the training prerequisites. Testing results from any interim recertifications must also be included, along with any relevant communications. (b) A searchable master electronic database of all persons for whom initial certification, third-year recertification or interim recertification. Information contained therein must include: The observer’s name, employer, address, telephone, cell and fax numbers and email address, along with the beginning and ending dates for each successfully completed initial, third-year and interim recertification. 10.1.7 Failure by the training provider to submit example training course materials and/or requested training records to the Administrator may result in suspension of the approval of the provider and course. 10.2 Observer Certification/ Recertification. The coke oven observer certification is valid for 1 year. The observer shall recertify annually by reviewing the training material, viewing the training video and answering all of the questions on the recertification test correctly. Every 3 years, an observer shall be required to pass the proficiency test in section 10.1.3 in order to be certified. The years between proficiency tests are referred to as interim years. 40 CFR Part 180 good agricultural practices. MacIntosh and Associates, Inc. (on behalf of AgBiTech Pty Ltd.) 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 Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2 under FFDCA. DATES: This regulation is effective November 22, 2016. Objections and requests for hearings must be received on or before January 23, 2017, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2015–0488, is available at https://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 https://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: [EPA–HQ–OPP–2015–0488; FRL–9953–40] I. General Information Spodoptera frugiperda Multiple Nucleopolyhedrovirus Strain 3AP2; Exemption From the Requirement of a Tolerance A. Does this action apply to me? * * * * * [FR Doc. 2016–28097 Filed 11–21–16; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY Environmental Protection Agency (EPA). ACTION: Final rule. AGENCY: This regulation establishes an exemption from the requirement of a tolerance for residues of Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2 in or on all food commodities when used in accordance with label directions and SUMMARY: PO 00000 Frm 00080 Fmt 4700 Sfmt 4700 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). E:\FR\FM\22NOR1.SGM 22NOR1 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Rules and Regulations available at https://www.epa.gov/ dockets. 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 https:// www.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. sradovich on DSK3GMQ082PROD with RULES • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). In the Federal Register of November 25, 2015 (80 FR 73695) (FRL–9937–14), 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 5F8361) by MacIntosh and Associates, Inc., 1203 Hartford Ave., St. Paul, MN 55116–1622 (on behalf of AgBiTech Pty Ltd, 8 Rocla Ct., Glenvale, Queensland 4350, Australia). The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Spodoptera frugiperda multiple nucleopolyhedrovirus—3AP2 in or on food crops. That document referenced a summary of the petition prepared by the petitioner MacIntosh and Associates, Inc. (on behalf of AgBiTech Pty Ltd), which is available in the docket via https://www.regulations.gov. There were no comments received in response to the notice of filing. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA–HQ– OPP–2015–0488 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before January 23, 2017. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA–HQ–OPP– 2015–0488, by one of the following methods: • Federal eRulemaking Portal: https:// 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 https:// www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is VerDate Sep<11>2014 16:34 Nov 21, 2016 Jkt 241001 II. Background 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 PO 00000 Frm 00081 Fmt 4700 Sfmt 4700 83705 other substances that have a common mechanism of toxicity.’’ EPA evaluated the available toxicity and exposure data on Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2 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 August 31, 2016, document entitled ‘‘Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Spodoptera frugiperda Multiple Nucleopolyhedrovirus strain 3AP2.’’ 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 Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2. Therefore, an exemption from the requirement of a tolerance is established for residues of Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2 in or on all food commodities when used in accordance with label directions and good agricultural practices. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes for the reasons contained in the August 31, 2016, document entitled ‘‘Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Spodoptera frugiperda Multiple Nucleopolyhedrovirus strain 3AP2’’ 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 E:\FR\FM\22NOR1.SGM 22NOR1 83706 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Rules and Regulations sradovich on DSK3GMQ082PROD with RULES Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’ (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance exemption in this action, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes. As a result, this action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, EPA has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, EPA has determined that Executive Order 13132, entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999), and Executive Order 13175, entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000), do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.). This action does not involve any technical standards that would require EPA’s consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note). V. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to VerDate Sep<11>2014 16:34 Nov 21, 2016 Jkt 241001 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: October 20, 2016. Jack E. Housenger, 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. Add § 180.1339 to subpart D to read as follows: ■ § 180.1339 Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for residues of Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2 in or on all food commodities when used in accordance with label directions and good agricultural practices. [FR Doc. 2016–28099 Filed 11–21–16; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION 47 CFR Part 54 [WC Docket No. 10–90; FCC 16–143] Connect America Fund Federal Communications Commission. ACTION: Final rule. AGENCY: In this document, the Federal Communications Commission (Commission) adopts tailored service obligations for Alaska Communications Systems (ACS), a carrier serving a noncontiguous area that elected to receive nearly $20 million annually in Connect America Phase II frozen support amounts in lieu of model-based support. DATES: Effective December 22, 2016, except for the certification in paragraph 33 which contains a new information collection requirement that will not be effective until approved by the Office of Management and Budget. The Commission will publish a document in SUMMARY: PO 00000 Frm 00082 Fmt 4700 Sfmt 4700 the Federal Register announcing the effective date for that certification. FOR FURTHER INFORMATION CONTACT: Alexander Minard, Wireline Competition Bureau, (202) 418–7400 or TTY: (202) 418–0484. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s Order in WC Docket No. 10–90; FCC 16–143, adopted on October 24, 2016 and released on October 31, 2016. The full text of this document is available for public inspection during regular business hours in the FCC Reference Center, Room CY–A257, 445 12th Street SW., Washington, DC 20554, or at the following Internet address: https:// transition.fcc.gov/Daily_Releases/Daily_ Business/2016/db1031/FCC-16143A1.pdf. I. Introduction 1. In this Order, the Commission adopts tailored service obligations for Alaska Communications Systems (ACS), a carrier serving a non-contiguous area that elected to receive nearly $20 million annually in Connect America Phase II frozen support amounts in lieu of model-based support. The Commission finds these obligations are in the public interest and will advance the Commission’s goal of ensuring universal availability of modern networks capable of providing voice and broadband service. Specifically, ACS will receive Phase II frozen support for a 10-year term and be required to offer voice service and broadband service at the same speed, latency, usage and pricing metrics as established for Phase II model-based carriers to at least 31,571 locations, primarily in census blocks identified as high-cost that are unserved by unsubsidized competitors, with limited exceptions. These service obligations strike the appropriate balance of ensuring Alaska consumers receive broadband service while also allowing ACS the flexibility to provide that service in a way that is logical, maximizes its network and is reasonable considering the unique climate and geographic conditions of its service territory. II. Discussion 2. As described below, the Commission adopts specific service obligations for ACS as a non-contiguous carrier electing to receive Phase II frozen support. The service obligations established today maintain many of the same public interest standards as those established for model-based price cap carriers, but allow flexibility in both buildout locations and the deployment schedule to account for the distinctive E:\FR\FM\22NOR1.SGM 22NOR1

Agencies

[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Rules and Regulations]
[Pages 83704-83706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28099]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0488; FRL-9953-40]


Spodoptera frugiperda Multiple Nucleopolyhedrovirus Strain 3AP2; 
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 Spodoptera frugiperda multiple 
nucleopolyhedrovirus strain 3AP2 in or on all food commodities when 
used in accordance with label directions and good agricultural 
practices. MacIntosh and Associates, Inc. (on behalf of AgBiTech Pty 
Ltd.) 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 Spodoptera frugiperda multiple 
nucleopolyhedrovirus strain 3AP2 under FFDCA.

DATES: This regulation is effective November 22, 2016. Objections and 
requests for hearings must be received on or before January 23, 2017, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0488, is available at https://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 https://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).

[[Page 83705]]

     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 https://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

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

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0488 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
January 23, 2017. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0488, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background

    In the Federal Register of November 25, 2015 (80 FR 73695) (FRL-
9937-14), 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 5F8361) by MacIntosh and Associates, Inc., 1203 Hartford 
Ave., St. Paul, MN 55116-1622 (on behalf of AgBiTech Pty Ltd, 8 Rocla 
Ct., Glenvale, Queensland 4350, Australia). The petition requested that 
40 CFR part 180 be amended by establishing an exemption from the 
requirement of a tolerance for residues of Spodoptera frugiperda 
multiple nucleopolyhedrovirus--3AP2 in or on food crops. That document 
referenced a summary of the petition prepared by the petitioner 
MacIntosh and Associates, Inc. (on behalf of AgBiTech Pty Ltd), which 
is available in the docket via https://www.regulations.gov. There were 
no comments received in response to the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings but does not include 
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 
Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2 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 August 31, 2016, document entitled 
``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 
Spodoptera frugiperda Multiple Nucleopolyhedrovirus strain 3AP2.'' 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 Spodoptera frugiperda 
multiple nucleopolyhedrovirus strain 3AP2. Therefore, an exemption from 
the requirement of a tolerance is established for residues of 
Spodoptera frugiperda multiple nucleopolyhedrovirus strain 3AP2 in or 
on all food commodities when used in accordance with label directions 
and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes for 
the reasons contained in the August 31, 2016, document entitled 
``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 
Spodoptera frugiperda Multiple Nucleopolyhedrovirus strain 3AP2'' 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

[[Page 83706]]

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

V. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: October 20, 2016.
Jack E. Housenger,
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. Add Sec.  180.1339 to subpart D to read as follows:


Sec.  180.1339  Spodoptera frugiperda multiple nucleopolyhedrovirus 
strain 3AP2; exemption from the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of Spodoptera frugiperda multiple nucleopolyhedrovirus strain 
3AP2 in or on all food commodities when used in accordance with label 
directions and good agricultural practices.

[FR Doc. 2016-28099 Filed 11-21-16; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.