82 FR 56173 - Polyethyleneimine; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 227 (November 28, 2017)
Federal Register Volume 82, Issue 227 (November 28, 2017)
| Page Range | 56173-56176 | |
| FR Document | 2017-25715 |
[Federal Register Volume 82, Number 227 (Tuesday, November 28, 2017)] [Rules and Regulations] [Pages 56173-56176] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25715] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0616; FRL-9970-06] Polyethyleneimine; 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 polyethyleneimine when used as an inert ingredient in a pesticide chemical formulation on growing crops and raw agricultural commodities after harvest. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of polyethyleneimine when used as an inert in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. DATES: This regulation is effective November 28, 2017. Objections and requests for hearings must be received on or before January 29, 2018, 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-2016-0616, 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 [[Page 56174]] 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: Michael Goodis, Director, Registration Division (7505P), 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, 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-2016-0616 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 29, 2018. 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-2016-0616, 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. Petition for Exemption In the Federal Register of February 7, 2017 (82 FR 9555) (FRL-9956- 86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-10981) by Spring Trading Company, LLC, on behalf of BASF Corporation, 100 Campus Drive, Florham, NJ 07932. The petition requested that 40 CFR 180.910 be amended by establishing an exemption from the requirement of a tolerance for residues of polyethyleneimine (CAS Reg. No. 9002-98-6) when used as an inert ingredient emulsifier, surfactant, adjuvant, dispersant, and/or coating in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. That document referenced a summary of the petition prepared by BASF Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing. III. Inert Ingredient Definition Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term ``inert'' is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients. IV. Aggregate Risk Assessment and Determination of Safety 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 tolerance is ``safe.'' Section 408(b)(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. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance 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. . . .'' EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert ingredient in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other [[Page 56175]] exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established. Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for polyethyleneimine including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with polyethyleneimine follows. Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. In the case of certain chemical substances that are defined as polymers, the Agency has established a set of criteria to identify categories of polymers expected to present minimal or no risk. The definition of a polymer is given in 40 CFR 723.250(b) and the exclusion criteria for identifying these low-risk polymers are described in 40 CFR 723.250(d). Polyethyleneimine conforms to the definition of a polymer given in 40 CFR 723.250(b) and meets the following criteria that are used to identify low-risk polymers. 1. The polymer does contain as an integral part of its composition at least two of the atomic elements carbon, hydrogen, nitrogen, oxygen, silicon, and sulfur. 2. The polymer does not contain as an integral part of its composition, except as impurities, any element other than those listed in 40 CFR 723.250(d)(2)(ii). 3. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 4. The polymer is manufactured or imported from monomers and/or reactants that are already included on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 5. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. 6. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as listed in 40 CFR 723.250(d)(6). Additionally, the polymer also meets as required the following exemption criteria: Specified in 40 CFR 723.250(e): 7. The polymer's number average MW of 1,300 is greater than 1,000 and less than 10,000 daltons. The polymer contains less than 10% oligomeric material below MW 500 and less than 25% oligomeric material below MW 1,000, and the polymer does not contain any reactive functional groups. Polyethyleneimine conforms to the definition of polymer and meets all of the exclusion criteria in 40 CFR Sec. 723.250, as listed in this section, except that it is cationic. Cationic polymers are excluded from the polymer exemption from tolerance under 40 CFR Sec. 723.250 (in which manufacture and distribution of polymers meeting the exemption criteria can take place without submission of a Premanufacture Notice (PMN) or an exemption notice prior to commencement of manufacture for a commercial purpose) because of their potential to cause aquatic toxicity. The petitioner has submitted aquatic toxicity studies and based on these studies, the Agency does not expect toxicity to nontarget aquatic organisms. Because of its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to polyethyleneimine. V. Aggregate Exposure For the purposes of assessing potential exposure under this exemption, EPA considered that polyethyleneimine could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The number average MW of polyethyleneimine is 1,300 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since polyethyleneimine conforms to the human health criteria that identify a low-risk polymer, there are no concerns for risks associated with any potential exposure scenarios that are reasonably foreseeable. The Agency has determined that a tolerance is not necessary to protect the public health. VI. Cumulative Effects From Substances With a Common Mechanism of Toxicity Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider ``available information'' concerning the cumulative effects of a particular pesticide's residues and ``other substances that have a common mechanism of toxicity.'' EPA has not found polyethyleneimine to share a common mechanism of toxicity with any other substances, and polyethyleneimine does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that polyethyleneimine does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative. VII. Additional Safety Factor for the Protection of Infants and Children Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base unless EPA concludes that a different margin of safety will be safe for infants and children. Due to the expected low toxicity of polyethyleneimine, based on its conformance to the human health criteria under 40 CFR 723.250, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VIII. Determination of Safety Taking into consideration all available information on polyethyleneimine with a minimum number average molecular weight of 1,300 amu, EPA has determined that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure to polyethyleneimine under reasonable foreseeable circumstances. Therefore, the establishment of an exemption from tolerance under 40 CFR 180.910 for residues of polyethyleneimine when used as an inert ingredient in pesticide formulations applied to growing crops and raw agricultural commodities after harvest, is safe under FFDCA section 408. [[Page 56176]] IX. Analytical Enforcement Methodology An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation. X. Conclusions Therefore, an exemption from the requirement of a tolerance is established under 40 CFR 180.910 for polyethyleneimine with a number average molecular weight of 1,300 amu (CAS Reg. No. 9002-98-6) when used as an inert ingredient (emulsifier, surfactant, adjuvant, dispersant, and/or coating) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest. XI. Statutory and Executive Order Reviews This action establishes an exemption from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. 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); Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). 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 exemption in this final rule, 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, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency 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, the Agency 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 Agency 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). XII. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: November 14, 2017. Michael Goodis, Director, Registration Division. 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. In Sec. 180.910, add alphabetically the inert ingredient to the table to read as follows: Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Inert ingredients Limits Uses ------------------------------------------------------------------------ * * * * * * * Polyethyleneimine (CAS Reg. Minimum number Emulsifier, No. 9002-98-6). average molecular surfactant, weight 1,300 amu. adjuvant, dispersant and/or coating. * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2017-25715 Filed 11-27-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Rules and Regulations 56173
program are adequate to meet the state’s ‘‘Approval of Nebraska’s Air Quality 40 CFR Part 70
responsibilities under the CAA. Implementation Plan, Operating Permits Environmental protection,
DATES: The direct final rule published at Program, and 112(l) Program; Revision Administrative practice and procedure,
82 FR 46679, October 6, 2017, is to Nebraska Administrative Code,’’ Air pollution control, Intergovernmental
withdrawn effective November 28, 2017. published in the Federal Register on relations, Operating permits, Reporting
FOR FURTHER INFORMATION CONTACT:
October 5, 2017. Nebraska’s SIP revision and recordkeeping requirements.
Tracey Casburn, Environmental revised two chapters, ‘‘Definitions’’ and
‘‘Operating Permit Modifications; Dated: November 16, 2017.
Protection Agency, Air Planning and James B. Gulliford,
Development Branch, 11201 Renner Reopening for Cause’’. Specifically,
these revisions incorporated by Regional Administrator, Region 7.
Boulevard, Lenexa, Kansas 66219 at
(913) 551–7016, or by email at reference the list of organic compounds ■ Accordingly, the direct final rule
casburn.tracey@epa.gov. exempt from the definition of volatile published on October 5, 2017 (82 FR
organic compound (VOC) found in the 46420), is withdrawn effective
SUPPLEMENTARY INFORMATION: Due to
Code of Federal Regulations. November 28, 2017.
adverse comments, EPA is withdrawing Notification requirements for the
the direct final rule to approve the states operating permit program were
[FR Doc. 2017–25576 Filed 11–27–17; 8:45 am]
‘‘infrastructure’’ SIP revision for the amended to be consistent with the BILLING CODE 6560–50–P
2008 Ozone NAAQS. In the direct final Federal operating permit program
rule published on October 6, 2017, (82 requirements, and the definition of
FR 46679), EPA stated that if it received ENVIRONMENTAL PROTECTION
‘‘solid waste’’ was revised by the state. AGENCY
adverse comment by November 6, 2017, However, because the state’s definition
the rule would be withdrawn and not is inconsistent with the Federal
take effect. EPA received adverse 40 CFR Part 180
definition, EPA was not approving the
comments. EPA will address the definition into the SIP. Finally, the state [EPA–HQ–OPP–2016–0616; FRL–9970–06]
comments in a subsequent final action extended the process of ‘‘off-permit
based upon the proposed action also Polyethyleneimine; Exemption From
changes’’ to Class 1 operating permits.
published on October 6, 2017 at 82 FR the Requirement of a Tolerance
Additional grammatical and editorial
46741. EPA will not institute a second changes were made in this revision. AGENCY: Environmental Protection
comment period on this action. Agency (EPA).
DATES: The direct final rule published at
List of Subjects in 40 CFR Part 52 82 FR 46420, October 5, 2017, is ACTION: Final rule.
Environmental protection, Air withdrawn effective November 28, 2017.
SUMMARY: This regulation establishes an
pollution control, Incorporation by FOR FURTHER INFORMATION CONTACT: Greg
exemption from the requirement of a
reference, Intergovernmental relations, Crable, Environmental Protection
tolerance for residues of
Nitrogen dioxide, Ozone, Reporting and Agency, Air Planning and Development
polyethyleneimine when used as an
recordkeeping requirements, Volatile Branch, 11201 Renner Boulevard,
inert ingredient in a pesticide chemical
organic compounds. Lenexa, Kansas 66219 at (913) 551–
formulation on growing crops and raw
Dated: November 16, 2017.
7391, or by email at crable.gregory@
agricultural commodities after harvest.
epa.gov.
James B. Gulliford, BASF Corporation submitted a petition
Regional Administrator, Region 7. SUPPLEMENTARY INFORMATION: Due to to EPA under the Federal Food, Drug,
adverse comments, EPA is withdrawing and Cosmetic Act (FFDCA), requesting
■ Accordingly, the amendment to 40 the direct final rule to approve revisions establishment of an exemption from the
CFR 52.1320(e) published on October 6, to the Nebraska State Implementation requirement of a tolerance. This
2017 (82 FR 46679) is withdrawn Plan (SIP), Operating Permits Program, regulation eliminates the need to
effective November 28, 2017. and 112(l) program; Revision to establish a maximum permissible level
[FR Doc. 2017–25569 Filed 11–27–17; 8:45 am] Nebraska Administrative Code. In the for residues of polyethyleneimine when
BILLING CODE 6560–50–P direct final rule published on October 5, used as an inert in pesticide
2017, (82 FR 46420), we stated that if we formulations applied to growing crops
received adverse comment by November and raw agricultural commodities after
ENVIRONMENTAL PROTECTION 6, 2017, the rule would be withdrawn harvest.
AGENCY and not take effect. EPA received DATES: This regulation is effective
adverse comments. EPA will address the November 28, 2017. Objections and
40 CFR Parts 52 and 70 comments in a subsequent final action requests for hearings must be received
[EPA–R07–OAR–2017–0485; FRL–9971–15– based upon the proposed action also on or before January 29, 2018, and must
Region 7] published on October 5, 2017 (82 FR be filed in accordance with the
46453). EPA will not institute a second instructions provided in 40 CFR part
Approval of Nebraska’s Air Quality comment period on this action. 178 (see also Unit I.C. of the
Implementation Plan, Operating SUPPLEMENTARY INFORMATION).
Permits Program, and 112(l) Program; List of Subjects
ADDRESSES: The docket for this action,
Revision to Nebraska Administrative 40 CFR Part 52 identified by docket identification (ID)
Code; Withdrawal of Direct Final Rule
Environmental protection, Air number EPA–HQ–OPP–2016–0616, is
jstallworth on DSKBBY8HB2PROD with RULES
AGENCY: Environmental Protection pollution control, Carbon monoxide, available at http://www.regulations.gov
Agency (EPA). Incorporation by reference, or at the Office of Pesticide Programs
ACTION: Withdrawal of direct final rule. Intergovernmental relations, Lead, Regulatory Public Docket (OPP Docket)
Nitrogen dioxide, Ozone, Particulate in the Environmental Protection Agency
SUMMARY: Due to adverse comments, the matter, Reporting and recordkeeping Docket Center (EPA/DC), West William
Environmental Protection Agency (EPA) requirements, Sulfur oxides, Volatile Jefferson Clinton Bldg., Rm. 3334, 1301
is withdrawing the direct final rule for organic compounds. Constitution Ave. NW., Washington, DC
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![56176 Federal Register / Vol. 82, No. 227 / Tuesday, November 28, 2017 / Rules and Regulations
IX. Analytical Enforcement collections subject to OMB approval This action does not involve any
Methodology under the Paperwork Reduction Act technical standards that would require
An analytical method is not required (PRA) (44 U.S.C. 3501 et seq.), nor does Agency consideration of voluntary
for enforcement purposes since the it require any special considerations consensus standards pursuant to section
Agency is establishing an exemption under Executive Order 12898, entitled 12(d) of the National Technology
from the requirement of a tolerance ‘‘Federal Actions to Address Transfer and Advancement Act
without any numerical limitation. Environmental Justice in Minority (NTTAA) (15 U.S.C. 272 note).
Populations and Low-Income
X. Conclusions Populations’’ (59 FR 7629, February 16, XII. Congressional Review Act
Therefore, an exemption from the 1994). Pursuant to the Congressional Review
requirement of a tolerance is established Since tolerances and exemptions that Act (5 U.S.C. 801 et seq.), EPA will
under 40 CFR 180.910 for are established on the basis of a petition submit a report containing this rule and
polyethyleneimine with a number under FFDCA section 408(d), such as other required information to the U.S.
average molecular weight of 1,300 amu the exemption in this final rule, do not Senate, the U.S. House of
(CAS Reg. No. 9002–98–6) when used as require the issuance of a proposed rule,
Representatives, and the Comptroller
an inert ingredient (emulsifier, the requirements of the Regulatory
General of the United States prior to
surfactant, adjuvant, dispersant, and/or Flexibility Act (RFA) (5 U.S.C. 601 et
publication of the rule in the Federal
coating) in pesticide formulations seq.), do not apply.
Register. This action is not a ‘‘major
applied to growing crops and raw This action directly regulates growers,
rule’’ as defined by 5 U.S.C. 804(2).
agricultural commodities after harvest. food processors, food handlers, and food
retailers, not States or tribes, nor does List of Subjects in 40 CFR Part 180
XI. Statutory and Executive Order this action alter the relationships or
Reviews distribution of power and Environmental protection,
This action establishes an exemption responsibilities established by Congress Administrative practice and procedure,
from the requirement of a tolerance in the preemption provisions of FFDCA Agricultural commodities, Pesticides
under FFDCA section 408(d) in section 408(n)(4). As such, the Agency and pests, Reporting and recordkeeping
response to a petition submitted to the has determined that this action will not requirements.
Agency. The Office of Management and have a substantial direct effect on States Dated: November 14, 2017.
Budget (OMB) has exempted these types or tribal governments, on the Michael Goodis,
of actions from review under Executive relationship between the national
Director, Registration Division.
Order 12866, entitled ‘‘Regulatory government and the States or tribal
Planning and Review’’ (58 FR 51735, governments, or on the distribution of Therefore, 40 CFR chapter I is
October 4, 1993). Because this action power and responsibilities among the amended as follows:
has been exempted from review under various levels of government or between
Executive Order 12866, this action is the Federal Government and Indian PART 180—[AMENDED]
not subject to Executive Order 13211, tribes. Thus, the Agency has determined
entitled ‘‘Actions Concerning that Executive Order 13132, entitled ■ 1. The authority citation for part 180
Regulations That Significantly Affect ‘‘Federalism’’ (64 FR 43255, August 10, continues to read as follows:
Energy Supply, Distribution, or Use’’ (66 1999) and Executive Order 13175,
Authority: 21 U.S.C. 321(q), 346a and 371.
FR 28355, May 22, 2001); Executive entitled ‘‘Consultation and Coordination
Order 13045, entitled ‘‘Protection of with Indian Tribal Governments’’ (65 FR ■ 2. In § 180.910, add alphabetically the
Children from Environmental Health 67249, November 9, 2000) do not apply inert ingredient to the table to read as
Risks and Safety Risks’’ (62 FR 19885, to this action. In addition, this action follows:
April 23, 1997); or Executive Order does not impose any enforceable duty or
13771, entitled ‘‘Reducing Regulations contain any unfunded mandate as § 180.910 Inert ingredients used pre- and
and Controlling Regulatory Costs’’ (82 described under Title II of the Unfunded post-harvest; exemptions from the
FR 9339, February 3, 2017). This action Mandates Reform Act (UMRA) (2 U.S.C. requirement of a tolerance.
does not contain any information 1501 et seq.). * * * * *
Inert ingredients Limits Uses
* * * * * * *
Polyethyleneimine (CAS Reg. No. 9002–98–6) Minimum number average molecular weight Emulsifier, surfactant, adjuvant, dispersant
1,300 amu. and/or coating.
* * * * * * *
[FR Doc. 2017–25715 Filed 11–27–17; 8:45 am]
BILLING CODE 6560–50–P
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Document Created: 2017-11-28 01:50:59
Document Modified: 2017-11-28 01:50:59
| 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 November 28, 2017. Objections and requests for hearings must be received on or before January 29, 2018, 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 | Michael Goodis, Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- | |
| FR Citation | 82 FR 56173 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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