81 FR 63707 - Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G; Temporary Exemptions From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 180 (September 16, 2016)
Federal Register Volume 81, Issue 180 (September 16, 2016)
| Page Range | 63707-63710 | |
| FR Document | 2016-22357 |
[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)] [Rules and Regulations] [Pages 63707-63710] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-22357] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0742; FRL-9951-44] Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G; Temporary Exemptions From the Requirement of a Tolerance AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes temporary exemptions from the requirement of a tolerance for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on the food and feed commodities of corn, field; corn, pop; and corn, sweet when [[Page 63708]] used in accordance with the terms of Experimental Use Permit (EUP) No. 91163-EUP-1. Interregional Research Project Number 4 (IR-4) submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting these temporary tolerance exemptions. This regulation eliminates the need under FFDCA to establish a maximum permissible level for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G when used under the terms of EUP No. 91163-EUP-1. The temporary tolerance exemptions expire on June 30, 2020. DATES: This regulation is effective September 16, 2016. Objections and requests for hearings must be received on or before November 15, 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-2015-0742, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2015-0742 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 November 15, 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-2015-0742, 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 February 9, 2016 (81 FR 6826) (FRL-9941- 42), 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 5E8397) by IR-4, Rutgers University, 500 College Rd. East, Suite 201W, Princeton, NJ 08540. The petition requested that 40 CFR part 180 be amended by establishing a temporary exemption from the requirement of a tolerance for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on corn. That document referenced a summary of the petition prepared by the petitioner IR-4, which is available in the docket via http://www.regulations.gov. There were no comments received in response to the notice of filing. EPA changed the commodity name reflected in the tolerance exemption expression from ``corn'' to ``food and feed commodities of corn, field; corn, pop; and corn, sweet'' and changed ``tolerance exemption'' to ``tolerance exemptions''. The reasons for these changes are explained in Unit III.C. III. Final Rule A. EPA's Safety Determination Section 408(r) of FFDCA authorizes EPA to establish a temporary exemption from the requirement of a tolerance for residues covered by an experimental use permit issued under the Federal Insecticide, Fungicide, and Rodenticide Act. That section states that the provisions of section 408(c)(2) of FFDCA apply to exemptions issued under FFDCA section 408(r). 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 [[Page 63709]] exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . . .'' Additionally, FFDCA section 408(b)(2)(D) requires that EPA consider ``available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity.'' EPA evaluated the available toxicity and exposure data on Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G 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 18, 2016, document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G.'' This document, as well as other relevant information, is available in the docket for this action as described under ADDRESSES. Based upon its evaluation, EPA concludes that Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G are not toxic, not pathogenic, and not infective. Although there may be some exposure to residues when used on corn in accordance with the terms of EUP No. 91163-EUP-1, there is a lack of concern due to the lack of potential for adverse effects. EPA also determined that retention of the Food Quality Protection Act (FQPA) safety factor was not necessary as part of the qualitative assessment conducted for Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G. Based upon its evaluation, EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G. Therefore, temporary exemptions from the requirement of a tolerance are established for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on the food and feed commodities of corn, field; corn, pop; and corn, sweet when used in accordance with the terms of EUP No. 91163-EUP-1. B. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes for the reasons contained in the August 18, 2016, document entitled ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G'' and because EPA is establishing temporary exemptions from the requirement of a tolerance without any numerical limitation. C. Revisions to the Requested Tolerance Exemption Two modifications have been made to the requested tolerance exemption. EPA changed ``corn'' to ``food and feed commodities of corn, field; corn, pop; and corn, sweet'' to align with the Agency's food and feed commodity vocabulary. EPA also changed ``tolerance exemption'' to ``tolerance exemptions'' as four different active ingredients are covered with this action. IV. Statutory and Executive Order Reviews This action establishes exemptions from the requirement of a tolerance 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 exemptions 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: August 30, 2016. Jack 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. [[Page 63710]] 0 2. Add Sec. 180.1338 to subpart D to read as follows: Sec. 180.1338 Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G; temporary exemptions from the requirement of a tolerance. Temporary exemptions from the requirement of a tolerance are established for residues of Aspergillus flavus strains TC16F, TC35C, TC38B, and TC46G in or on the food and feed commodities of corn, field; corn, pop; and corn, sweet when used in accordance with the terms of Experimental Use Permit No. 91163-EUP-1. These temporary exemptions from the requirement of a tolerance expire on June 30, 2020. [FR Doc. 2016-22357 Filed 9-15-16; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 81, No. 180 / Friday, September 16, 2016 / Rules and Regulations 63707
application of those requirements would report containing this action and other reference, Intergovernmental relations,
be inconsistent with the CAA; and required information to the U.S. Senate, Nitrogen dioxide, Ozone, Reporting and
• does not provide EPA with the the U.S. House of Representatives, and recordkeeping requirements, Volatile
discretionary authority to address, as the Comptroller General of the United organic compounds.
appropriate, disproportionate human States prior to publication of the rule in Dated: September 2, 2016.
health or environmental effects, using the Federal Register. A major rule
V. Anne Heard,
practicable and legally permissible cannot take effect until 60 days after it
methods, under Executive Order 12898 Acting Regional Administrator, Region 4.
is published in the Federal Register.
(59 FR 7629, February 16, 1994). This action is not a ‘‘major rule’’ as 40 CFR part 52 is amended as follows:
The SIP is not approved to apply on defined by 5 U.S.C. 804(2).
any Indian reservation land or in any Under section 307(b)(1) of the CAA, PART 52—APPROVAL AND
other area where EPA or an Indian tribe petitions for judicial review of this PROMULGATION OF
has demonstrated that a tribe has action must be filed in the United States IMPLEMENTATION PLANS
jurisdiction. In those areas of Indian Court of Appeals for the appropriate
country, the rule does not have tribal circuit by November 15, 2016. Filing a ■ 1. The authority citation for part 52
implications as specified by Executive petition for reconsideration by the continues to read as follows:
Order 13175 (65 FR 67249, November 9, Administrator of this final rule does not Authority: 42.U.S.C. 7401 et seq.
2000), nor will it impose substantial affect the finality of this action for the
direct costs on tribal governments or purposes of judicial review nor does it Subpart Z—Mississippi
preempt tribal law. extend the time within which a petition
The Congressional Review Act, 5 for judicial review may be filed, and ■ 2. Section 52.1270(e), is amended by
U.S.C. 801 et seq., as added by the Small shall not postpone the effectiveness of adding an entry for ‘‘110(a)(1) and (2)
Business Regulatory Enforcement such rule or action. This action may not Infrastructure Requirements for the 2010
Fairness Act of 1996, generally provides be challenged later in proceedings to 1-hour NO2 National Ambient Air
that before a rule may take effect, the enforce its requirements. See section Quality Standard’’ at the end of the table
agency promulgating the rule must 307(b)(2). to read as follows:
submit a rule report, which includes a
copy of the rule, to each House of the List of Subjects in 40 CFR Part 52 § 52.1270 Identification of plan.
Congress and to the Comptroller General Environmental protection, Air * * * * *
of the United States. EPA will submit a pollution control, Incorporation by (e) * * *
EPA APPROVED MISSISSIPPI NON-REGULATORY PROVISIONS
State
Applicable
Name of submittal
geographic or
nonregulatory date/ EPA approval date Explanation
nonattainment
SIP provision effective
area date
* * * * * * *
110(a)(1) and (2) Infrastruc- Mississippi ..... 02/28/2013 09/16/2016, [Insert With the exception of sections: 110(a)(2)(C) and (J)
ture Requirements for the Federal Register concerning PSD permitting requirements;
2010 1-hour NO2 Na- citation]. 110(a)(2)(D)(i)(I) and (II) (prongs 1 through 4) con-
tional Ambient Air Quality cerning interstate transport requirements and the
Standard. state board majority requirements respecting signifi-
cant portion of income of section 110(a)(2)(E)(ii).
■ 3. Section 52.1272 is amended by significant portion of income from ENVIRONMENTAL PROTECTION
adding a paragraph (d) to read as persons subject to permits or AGENCY
follows: enforcement orders issued by the
Mississippi Boards, and therefore, its 40 CFR Part 180
§ 52.1272 Approval status.
current SIP does not meet the section [EPA–HQ–OPP–2015–0742; FRL–9951–44]
* * * * * 128(a)(1) majority requirements
(d) Disapproval. Submittal from the respecting significant portion of income Aspergillus flavus strains TC16F,
State of Mississippi, through the for the 2010 1-hour NO2 NAAQS. TC35C, TC38B, and TC46G; Temporary
Mississippi Department of [FR Doc. 2016–22226 Filed 9–15–16; 8:45 am]
Exemptions From the Requirement of
Environmental Quality (MDEQ) on a Tolerance
BILLING CODE 6560–50–P
February 28, 2013, to address the Clean AGENCY: Environmental Protection
Air Act section 110(a)(2)(E)(ii) for the Agency (EPA).
2010 1-hour nitrogen dioxide (NO2) ACTION: Final rule.
National Ambient Air Quality Standards
(NAAQS) concerning state board SUMMARY: This regulation establishes
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majority requirements respecting temporary exemptions from the
significant portion of income of section requirement of a tolerance for residues
128(a)(1). EPA is disapproving MDEQ’s of Aspergillus flavus strains TC16F,
submittal with respect to section TC35C, TC38B, and TC46G in or on the
110(a)(2)(E)(ii) because a majority of food and feed commodities of corn,
board members may still derive a field; corn, pop; and corn, sweet when
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exemption from the requirement of a B. Analytical Enforcement Methodology This action directly regulates growers,
tolerance, EPA must take into account An analytical method is not required food processors, food handlers, and food
the factors set forth in FFDCA section for enforcement purposes for the retailers, not States or tribes. As a result,
408(b)(2)(C), which require EPA to give reasons contained in the August 18, this action does not alter the
special consideration to exposure of 2016, document entitled ‘‘Federal Food, relationships or distribution of power
infants and children to the pesticide Drug, and Cosmetic Act (FFDCA) and responsibilities established by
chemical residue in establishing a Congress in the preemption provisions
Considerations for Aspergillus flavus
tolerance or tolerance exemption and to of FFDCA section 408(n)(4). As such,
strains TC16F, TC35C, TC38B, and
‘‘ensure that there is a reasonable EPA has determined that this action will
TC46G’’ and because EPA is
certainty that no harm will result to not have a substantial direct effect on
establishing temporary exemptions from
infants and children from aggregate States or tribal governments, on the
the requirement of a tolerance without
exposure to the pesticide chemical relationship between the national
any numerical limitation.
residue . . . .’’ Additionally, FFDCA government and the States or tribal
section 408(b)(2)(D) requires that EPA C. Revisions to the Requested Tolerance governments, or on the distribution of
consider ‘‘available information Exemption power and responsibilities among the
concerning the cumulative effects of [a Two modifications have been made to various levels of government or between
particular pesticide’s] . . . residues and the Federal Government and Indian
the requested tolerance exemption. EPA
other substances that have a common tribes. Thus, EPA has determined that
changed ‘‘corn’’ to ‘‘food and feed
mechanism of toxicity.’’ Executive Order 13132, entitled
EPA evaluated the available toxicity commodities of corn, field; corn, pop;
and corn, sweet’’ to align with the ‘‘Federalism’’ (64 FR 43255, August 10,
and exposure data on Aspergillus flavus 1999), and Executive Order 13175,
strains TC16F, TC35C, TC38B, and Agency’s food and feed commodity
vocabulary. EPA also changed entitled ‘‘Consultation and Coordination
TC46G and considered its validity, with Indian Tribal Governments’’ (65 FR
completeness, and reliability, as well as ‘‘tolerance exemption’’ to ‘‘tolerance
exemptions’’ as four different active 67249, November 9, 2000), do not apply
the relationship of this information to to this action. In addition, this action
human risk. A full explanation of the ingredients are covered with this action.
does not impose any enforceable duty or
data upon which EPA relied and its risk IV. Statutory and Executive Order contain any unfunded mandate as
assessment based on that data can be Reviews described under Title II of the Unfunded
found within the August 18, 2016, Mandates Reform Act (UMRA) (2 U.S.C.
document entitled ‘‘Federal Food, Drug, This action establishes exemptions
from the requirement of a tolerance 1501 et seq.).
and Cosmetic Act (FFDCA)
under FFDCA section 408(d) in This action does not involve any
Considerations for Aspergillus flavus
response to a petition submitted to EPA. technical standards that would require
strains TC16F, TC35C, TC38B, and
The Office of Management and Budget EPA’s consideration of voluntary
TC46G.’’ This document, as well as
(OMB) has exempted these types of consensus standards pursuant to section
other relevant information, is available
in the docket for this action as described actions from review under Executive 12(d) of the National Technology
under ADDRESSES. Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
Based upon its evaluation, EPA Planning and Review’’ (58 FR 51735, (NTTAA) (15 U.S.C. 272 note).
concludes that Aspergillus flavus strains October 4, 1993). Because this action V. Congressional Review Act
TC16F, TC35C, TC38B, and TC46G are has been exempted from review under
not toxic, not pathogenic, and not Executive Order 12866, this action is Pursuant to the Congressional Review
infective. Although there may be some not subject to Executive Order 13211, Act (5 U.S.C. 801 et seq.), EPA will
exposure to residues when used on corn entitled ‘‘Actions Concerning submit a report containing this rule and
in accordance with the terms of EUP No. Regulations That Significantly Affect other required information to the U.S.
91163–EUP–1, there is a lack of concern Energy Supply, Distribution, or Use’’ (66 Senate, the U.S. House of
due to the lack of potential for adverse FR 28355, May 22, 2001), or Executive Representatives, and the Comptroller
effects. EPA also determined that Order 13045, entitled ‘‘Protection of General of the United States prior to
retention of the Food Quality Protection Children from Environmental Health publication of the rule in the Federal
Act (FQPA) safety factor was not Risks and Safety Risks’’ (62 FR 19885, Register. This action is not a ‘‘major
necessary as part of the qualitative April 23, 1997). This action does not rule’’ as defined by 5 U.S.C. 804(2).
assessment conducted for Aspergillus contain any information collections
List of Subjects in 40 CFR Part 180
flavus strains TC16F, TC35C, TC38B, subject to OMB approval under the
and TC46G. Paperwork Reduction Act (PRA) (44 Environmental protection,
Based upon its evaluation, EPA U.S.C. 3501 et seq.) nor does it require Administrative practice and procedure,
concludes that there is a reasonable any special considerations under Agricultural commodities, Pesticides
certainty that no harm will result to the Executive Order 12898, entitled and pests, Reporting and recordkeeping
U.S. population, including infants and ‘‘Federal Actions to Address requirements.
children, from aggregate exposure to Environmental Justice in Minority Dated: August 30, 2016.
residues of Aspergillus flavus strains Populations and Low-Income Jack Housenger,
TC16F, TC35C, TC38B, and TC46G. Populations’’ (59 FR 7629, February 16,
Director, Office of Pesticide Programs.
Therefore, temporary exemptions from 1994).
the requirement of a tolerance are Since tolerances and exemptions that Therefore, 40 CFR chapter I is
established for residues of Aspergillus are established on the basis of a petition amended as follows:
Lhorne on DSK30JT082PROD with RULES
flavus strains TC16F, TC35C, TC38B, under FFDCA section 408(d), such as
and TC46G in or on the food and feed the tolerance exemptions in this action, PART 180—[AMENDED]
commodities of corn, field; corn, pop; do not require the issuance of a
and corn, sweet when used in proposed rule, the requirements of the ■ 1. The authority citation for part 180
accordance with the terms of EUP No. Regulatory Flexibility Act (RFA) (5 continues to read as follows:
91163–EUP–1. U.S.C. 601 et seq.) do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
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■ 2. Add § 180.1338 to subpart D to read Regulatory Public Docket (OPP Docket) OPP–2013–0237 in the subject line on
as follows: in the Environmental Protection Agency the first page of your submission. All
Docket Center (EPA/DC), West William objections and requests for a hearing
§ 180.1338 Aspergillus flavus strains Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be
TC16F, TC35C, TC38B, and TC46G;
temporary exemptions from the
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or
requirement of a tolerance. 20460–0001. The Public Reading Room before November 15, 2016. Addresses
is open from 8:30 a.m. to 4:30 p.m., for mail and hand delivery of objections
Temporary exemptions from the
Monday through Friday, excluding legal and hearing requests are provided in 40
requirement of a tolerance are
holidays. The telephone number for the CFR 178.25(b).
established for residues of Aspergillus In addition to filing an objection or
flavus strains TC16F, TC35C, TC38B, Public Reading Room is (202) 566–1744,
and the telephone number for the OPP hearing request with the Hearing Clerk
and TC46G in or on the food and feed as described in 40 CFR part 178, please
commodities of corn, field; corn, pop; Docket is (703) 305–5805. Please review
the visitor instructions and additional submit a copy of the filing (excluding
and corn, sweet when used in any Confidential Business Information
accordance with the terms of information about the docket available
at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
Experimental Use Permit No. 91163– Information not marked confidential
EUP–1. These temporary exemptions FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division pursuant to 40 CFR part 2 may be
from the requirement of a tolerance disclosed publicly by EPA without prior
expire on June 30, 2020. (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
[FR Doc. 2016–22357 Filed 9–15–16; 8:45 am]
Pennsylvania Ave. NW., Washington, objection or hearing request, identified
BILLING CODE 6560–50–P
DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
number: (703) 305–7090; email address: 2013–0237, by one of the following
RDFRNotices@epa.gov. methods:
ENVIRONMENTAL PROTECTION • Federal eRulemaking Portal: http://
AGENCY SUPPLEMENTARY INFORMATION: www.regulations.gov. Follow the online
I. General Information instructions for submitting comments.
40 CFR Part 180 Do not submit electronically any
A. Does this action apply to me? information you consider to be CBI or
[EPA–HQ–OPP–2013–0237; FRL–9951–08]
You may be potentially affected by other information whose disclosure is
Ammonium Persulfate; Exemption this action if you are an agricultural restricted by statute.
From the Requirement of a Tolerance producer, food manufacturer, or • Mail: OPP Docket, Environmental
pesticide manufacturer. The following Protection Agency Docket Center (EPA/
AGENCY: Environmental Protection DC), (28221T), 1200 Pennsylvania Ave.
list of North American Industrial
Agency (EPA). NW., Washington, DC 20460–0001.
Classification System (NAICS) codes is
ACTION: Final rule.
not intended to be exhaustive, but rather • Hand Delivery: To make special
provides a guide to help readers arrangements for hand delivery or
SUMMARY: This regulation establishes an delivery of boxed information, please
exemption from the requirement of a determine whether this document
applies to them. Potentially affected follow the instructions at http://
tolerance for residues of ammonium www.epa.gov/dockets/contacts.html.
persulfate (CAS Reg. No.7727–54–0) entities may include:
when used as an inert ingredient • Crop production (NAICS code 111). Additional instructions on commenting
(preservative) in pesticide formulations • Animal production (NAICS code or visiting the docket, along with more
112). information about dockets generally, is
applied to growing crops and raw
agricultural commodities after harvest, • Food manufacturing (NAICS code available at http://www.epa.gov/
311). dockets.
etc.) at a concentration not to exceed
0.05% by weight. Exponent, Inc., on • Pesticide manufacturing (NAICS II. Petition for Exemption
behalf of Becker Underwood, Inc. code 32532).
In the Federal Register of June 5, 2013
submitted a petition to EPA under the B. How can I get electronic access to (78 FR 33785) (FRL–9386–2), EPA
Federal Food, Drug, and Cosmetic Act other related information? issued a document pursuant to FFDCA
(FFDCA), requesting establishment of an You may access a frequently updated section 408, 21 U.S.C. 346a, announcing
exemption from the requirement of a electronic version of 40 CFR part 180 the filing of a pesticide petition (PP
tolerance. This regulation eliminates the through the Government Printing 2E8096) by Exponent, Inc., 1150
need to establish a maximum Office’s e-CFR site at http:// Connecticut Ave., Suite 1100,
permissible level for residues of www.ecfr.gov/cgi-bin/text- Washington, DC 20036, on behalf of
ammonium persulfate under the idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ Becker Underwood, Inc., 801 Dayton
approved conditions. 40tab_02.tpl. Avenue, Ames, IA 50010. The petition
DATES: This regulation is effective requested that 40 CFR 180.910 be
September 16, 2016. Objections and C. How can I file an objection or hearing amended by establishing an exemption
requests for hearings must be received request? from the requirement of a tolerance for
on or before November 15, 2016, and Under FFDCA section 408(g), 21 residues of ammonium persulfate (CAS
must be filed in accordance with the U.S.C. 346a, any person may file an Reg. No. 7727–54–0) when used as an
instructions provided in 40 CFR part objection to any aspect of this regulation inert ingredient (preservative) in
178 (see also Unit I.C. of the and may also request a hearing on those pesticide formulations applied to
Lhorne on DSK30JT082PROD with RULES
SUPPLEMENTARY INFORMATION). objections. You must file your objection growing crops or raw agricultural
ADDRESSES: The docket for this action, or request a hearing on this regulation commodities after harvest at a
identified by docket identification (ID) in accordance with the instructions concentration not to exceed 0.05% by
number EPA–HQ–OPP–2013–0237, is provided in 40 CFR part 178. To ensure weight in pesticide formulations. That
available at http://www.regulations.gov proper receipt by EPA, you must document referenced a summary of the
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– petition prepared by Exponent, Inc., the
VerDate Sep<11>2014 13:04 Sep 15, 2016 Jkt 238001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\FR\FM\16SER1.SGM 16SER1](https://thefederalregister.org/doc/81_FR_63887/page/4.svg)
Document Created: 2016-09-16 00:25:34
Document Modified: 2016-09-16 00:25:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Rules and Regulations | |
| Action | Final rule. | |
| Dates | This regulation is effective September 16, 2016. Objections and requests for hearings must be received on or before November 15, 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). | |
| 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 | |
| FR Citation | 81 FR 63707 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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