83 FR 48552 - Maltodextrin-Vinyl Pyrrolidinone Copolymer; Exemption From the Requirement of a Tolerance
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 187 (September 26, 2018)
Federal Register Volume 83, Issue 187 (September 26, 2018)
| Page Range | 48552-48555 | |
| FR Document | 2018-20968 |
[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)] [Rules and Regulations] [Pages 48552-48555] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-20968] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2018-0289; FRL-9983-05] Maltodextrin-Vinyl Pyrrolidinone Copolymer; 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 maltodextrin-vinyl pyrrolidinone copolymer (CAS Reg. No. 1323833-56-2) when used as an inert ingredient in a pesticide chemical formulation. Akzo Nobel Surface Chemistry, LLC submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of maltodextrin-vinyl pyrrolidinone copolymer on food or feed commodities. DATES: This regulation is effective September 26, 2018. Objections and requests for hearings must be received on or before November 26, 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-2018-0289, 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: Michael Goodis, 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. 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-2018-0289 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 26, 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-2018-0289, by one of the following methods. Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. [[Page 48553]] 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 and Statutory Findings In the Federal Register of August 14, 2018 (83 FR 40272) (FRL-9981- 10), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-11127) filed by Akzo Nobel Surface Chemistry, LLC, 203 Dogwood Trail, Magnolia, TX 77354. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of maltodextrin-vinyl pyrrolidinone copolymer (CAS Reg. No. 1323833-56-2). That document included a summary of the petition prepared by the petitioner and solicited comments on the petitioner's request. The Agency did not receive any comments. 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 use 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 an exemption from the requirement of 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 . . .'' and specifies factors EPA is to consider in establishing an exemption. III. Risk Assessment and Statutory Findings EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be shown 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 in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other 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(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). Maltodextrin-vinyl pyrrolidinone copolymer 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 is not a cationic polymer nor is it reasonably anticipated to become a cationic polymer in a natural aquatic environment. 2. The polymer does contain as an integral part of its composition the atomic elements carbon, hydrogen, and oxygen. 3. 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). 4. The polymer is neither designed nor can it be reasonably anticipated to substantially degrade, decompose, or depolymerize. 5. The polymer is manufactured or imported from monomers and/or reactants that are already included on the TSCA Chemical Substance Inventory or manufactured under an applicable TSCA section 5 exemption. 6. The polymer is not a water absorbing polymer with a number average molecular weight (MW) greater than or equal to 10,000 daltons. 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 21,000 is greater than or equal to 10,000 daltons. The polymer contains less than 2% oligomeric material below MW 500 and less than 5% oligomeric material below MW 1,000. Thus, maltodextrin-vinyl pyrrolidinone copolymer meets the criteria for a polymer to be considered low risk under 40 CFR 723.250. Based on its conformance to the criteria in this unit, no mammalian toxicity is anticipated from dietary, inhalation, or dermal exposure to maltodextrin-vinyl pyrrolidinone copolymer. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that maltodextrin-vinyl pyrrolidinone copolymer could be present in all raw and processed agricultural commodities and drinking water, and that non-occupational non-dietary exposure was possible. The minimum number average MW of maltodextrin- vinyl pyrrolidinone copolymer is 21,000 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since maltodextrin-vinyl pyrrolidinone copolymer conform to the 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. V. 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 maltodextrin-vinyl pyrrolidinone copolymer to share a common mechanism of toxicity with any other substances, and maltodextrin- [[Page 48554]] vinyl pyrrolidinone copolymer does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that maltodextrin-vinyl pyrrolidinone copolymer 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 website at http://www.epa.gov/pesticides/cumulative. VI. 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 maltodextrin-vinyl pyrrolidinone copolymer, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. VII. Determination of Safety Based on the conformance to the criteria used to identify a low- risk polymer, EPA concludes that there is a reasonable certainty of no harm to the U.S. population, including infants and children, from aggregate exposure to residues of maltodextrin-vinyl pyrrolidinone copolymer. VIII. Other Considerations A. 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. B. International Residue Limits In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex has not established a MRL for maltodextrin-vinyl pyrrolidinone copolymer. IX. Conclusion Accordingly, EPA finds that exempting residues of maltodextrin- vinyl pyrrolidinone copolymer from the requirement of a tolerance will be safe. X. Statutory and Executive Order Reviews This action establishes 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) 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 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). XI. Congressional Review Act Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a ``major rule'' as defined by 5 U.S.C. 804(2). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements. Dated: September 7, 2018. Michael Goodis, Director, Registration Division, 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. In Sec. 180.960, add alphabetically the polymer ``Maltodextrin- vinyl pyrrolidinone copolymer, minimum number average molecular weight (in amu), 21,000'' to the table to read as follows: Sec. 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * [[Page 48555]] ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * Maltodextrin-vinyl pyrrolidinone copolymer, minimum 1323833-56-2 number average molecular weight (in amu), 21,000....... * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2018-20968 Filed 9-25-18; 8:45 am] BILLING CODE 6560-50-P
![48552 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Rules and Regulations
Dated: September 13, 2018. PART 180—[AMENDED] dimethyl-3-oxobutyl)-2-propenamide,
Michael Goodis, ethenylbenzene, 2-ethylhexyl 2-
Director, Registration Division, Office of ■ 1. The authority citation for part 180 propenoate and methyl 2-methyl-2-
Pesticide Programs. continues to read as follows: propenoate, minimum number average
Authority: 21 U.S.C. 321(q), 346a and 371. molecular weight (in amu), 7,300’’ to the
Therefore, 40 CFR chapter I is table to read as follows:
amended as follows: ■ 2. In § 180.960, add alphabetically the
polymer ‘‘2-Propenoic acid, 2-methyl-, § 180.960 Polymers; exemptions from the
polymer with butyl 2-methyl-2- requirement of a tolerance.
propenoate, butyl 2-propenoate, N-(1,1- * * * * *
Polymer CAS No.
* * * * * * *
2-Propenoic acid, 2-methyl-, polymer with butyl 2-methyl-2-propenoate, butyl 2-propenoate, N-(1,1-dimethyl-3-oxobutyl)-2-
propenamide, ethenylbenzene, 2-ethylhexyl 2-propenoate and methyl 2-methyl-2-propenoate, minimum number average mo-
lecular weight (in amu), 7,300 ......................................................................................................................................................... 481053–27–4
* * * * * * *
[FR Doc. 2018–20969 Filed 9–25–18; 8:45 am] Regulatory Public Docket (OPP Docket) B. How can i get electronic access to
BILLING CODE 6560–50–P in the Environmental Protection Agency other related information?
Docket Center (EPA/DC), West William You may access a frequently updated
Jefferson Clinton Bldg., Rm. 3334, 1301 electronic version of 40 CFR part 180
ENVIRONMENTAL PROTECTION Constitution Ave. NW, Washington, DC through the Government Printing
AGENCY 20460–0001. The Public Reading Room Office’s e-CFR site at http://
is open from 8:30 a.m. to 4:30 p.m., www.ecfr.gov/cgi-bin/text-idx?&c=ecfr
40 CFR Part 180 Monday through Friday, excluding legal &tpl=/ecfrbrowse/Title40/40tab_02.tpl.
[EPA–HQ–OPP–2018–0289; FRL–9983–05] holidays. The telephone number for the
Public Reading Room is (202) 566–1744, C. Can I file an objection or hearing
Maltodextrin-Vinyl Pyrrolidinone and the telephone number for the OPP request?
Copolymer; Exemption From the Docket is (703) 305–5805. Please review Under FFDCA section 408(g), 21
Requirement of a Tolerance the visitor instructions and additional U.S.C. 346a, any person may file an
AGENCY: Environmental Protection information about the docket available objection to any aspect of this regulation
Agency (EPA). at http://www.epa.gov/dockets. and may also request a hearing on those
ACTION: Final rule. FOR FURTHER INFORMATION CONTACT: objections. You must file your objection
Michael Goodis, Registration Division or request a hearing on this regulation
SUMMARY: This regulation establishes an (7505P), Office of Pesticide Programs, in accordance with the instructions
exemption from the requirement of a Environmental Protection Agency, 1200 provided in 40 CFR part 178. To ensure
tolerance for residues of maltodextrin- Pennsylvania Ave. NW, Washington, DC proper receipt by EPA, you must
vinyl pyrrolidinone copolymer (CAS 20460–0001; main telephone number: identify docket ID number EPA–HQ–
Reg. No. 1323833–56–2) when used as (703) 305–7090; email address: OPP–2018–0289 in the subject line on
an inert ingredient in a pesticide RDFRNotices@epa.gov. the first page of your submission. All
chemical formulation. Akzo Nobel objections and requests for a hearing
Surface Chemistry, LLC submitted a SUPPLEMENTARY INFORMATION:
must be in writing, and must be
petition to EPA under the Federal Food, I. General Information received by the Hearing Clerk on or
Drug, and Cosmetic Act (FFDCA), before November 26, 2018. Addresses
requesting an exemption from the A. Does this action apply to me? for mail and hand delivery of objections
requirement of a tolerance. This You may be potentially affected by and hearing requests are provided in 40
regulation eliminates the need to this action if you are an agricultural CFR 178.25(b).
establish a maximum permissible level producer, food manufacturer, or In addition to filing an objection or
for residues of maltodextrin-vinyl pesticide manufacturer. The following hearing request with the Hearing Clerk
pyrrolidinone copolymer on food or list of North American Industrial as described in 40 CFR part 178, please
feed commodities. Classification System (NAICS) codes is submit a copy of the filing (excluding
DATES: This regulation is effective not intended to be exhaustive, but rather any Confidential Business Information
September 26, 2018. Objections and provides a guide to help readers (CBI)) for inclusion in the public docket.
requests for hearings must be received determine whether this document Information not marked confidential
on or before November 26, 2018, and applies to them. Potentially affected pursuant to 40 CFR part 2 may be
must be filed in accordance with the entities may include: disclosed publicly by EPA without prior
instructions provided in 40 CFR part notice. Submit the non-CBI copy of your
• Crop production (NAICS code 111).
178 (see also Unit I.C. of the objection or hearing request, identified
daltland on DSKBBV9HB2PROD with RULES
SUPPLEMENTARY INFORMATION). • Animal production (NAICS code by docket ID number EPA–HQ–OPP–
ADDRESSES: The docket for this action,
112). 2018–0289, by one of the following
identified by docket identification (ID) • Food manufacturing (NAICS code methods.
number EPA–HQ–OPP–2018–0289, is 311). • Federal eRulemaking Portal: http://
available at http://www.regulations.gov • Pesticide manufacturing (NAICS www.regulations.gov. Follow the online
or at the Office of Pesticide Programs code 32532). instructions for submitting comments.
VerDate Sep<11>2014 17:04 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00032 Fmt 4700 Sfmt 4700 E:\FR\FM\26SER1.SGM 26SER1](https://thefederalregister.org/doc/83_FR_48739/page/1.svg)
![48554 Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Rules and Regulations
vinyl pyrrolidinone copolymer does not food safety standards-setting or tribal governments, on the
appear to produce a toxic metabolite organization in trade agreements to relationship between the national
produced by other substances. For the which the United States is a party. EPA government and the States or tribal
purposes of this tolerance action, may establish a tolerance that is governments, or on the distribution of
therefore, EPA has assumed that different from a Codex MRL; however, power and responsibilities among the
maltodextrin-vinyl pyrrolidinone FFDCA section 408(b)(4) requires that various levels of government or between
copolymer does not have a common EPA explain the reasons for departing the Federal Government and Indian
mechanism of toxicity with other from the Codex level. tribes. Thus, the Agency has determined
substances. For information regarding The Codex has not established a MRL that Executive Order 13132, entitled
EPA’s efforts to determine which for maltodextrin-vinyl pyrrolidinone ‘‘Federalism’’ (64 FR 43255, August 10,
chemicals have a common mechanism copolymer. 1999) and Executive Order 13175,
of toxicity and to evaluate the IX. Conclusion entitled ‘‘Consultation and Coordination
cumulative effects of such chemicals, with Indian Tribal Governments’’ (65 FR
see EPA’s website at http:// Accordingly, EPA finds that 67249, November 9, 2000) do not apply
www.epa.gov/pesticides/cumulative. exempting residues of maltodextrin- to this action. In addition, this action
vinyl pyrrolidinone copolymer from the does not impose any enforceable duty or
VI. Additional Safety Factor for the requirement of a tolerance will be safe.
Protection of Infants and Children contain any unfunded mandate as
X. Statutory and Executive Order described under Title II of the Unfunded
Section 408(b)(2)(C) of FFDCA Reviews Mandates Reform Act (UMRA) (2 U.S.C.
provides that EPA shall apply an 1501 et seq.).
additional tenfold margin of safety for This action establishes a tolerance
This action does not involve any
infants and children in the case of under FFDCA section 408(d) in
response to a petition submitted to the technical standards that would require
threshold effects to account for prenatal Agency consideration of voluntary
and postnatal toxicity and the Agency. The Office of Management and
Budget (OMB) has exempted these types consensus standards pursuant to section
completeness of the data base unless 12(d) of the National Technology
EPA concludes that a different margin of of actions from review under Executive
Order 12866, entitled ‘‘Regulatory Transfer and Advancement Act
safety will be safe for infants and (NTTAA) (15 U.S.C. 272 note).
children. Due to the expected low Planning and Review’’ (58 FR 51735,
toxicity of maltodextrin-vinyl October 4, 1993). Because this action XI. Congressional Review Act
pyrrolidinone copolymer, EPA has not has been exempted from review under Pursuant to the Congressional Review
used a safety factor analysis to assess Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
the risk. For the same reasons the not subject to Executive Order 13211, submit a report containing this rule and
additional tenfold safety factor is entitled ‘‘Actions Concerning other required information to the U.S.
unnecessary. Regulations That Significantly Affect Senate, the U.S. House of
Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller
VII. Determination of Safety FR 28355, May 22, 2001) or Executive General of the United States prior to
Based on the conformance to the Order 13045, entitled ‘‘Protection of publication of the rule in the Federal
criteria used to identify a low-risk Children from Environmental Health Register. This action is not a ‘‘major
polymer, EPA concludes that there is a Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2).
reasonable certainty of no harm to the April 23, 1997). This action does not
U.S. population, including infants and contain any information collections List of Subjects in 40 CFR Part 180
children, from aggregate exposure to subject to OMB approval under the Environmental protection,
residues of maltodextrin-vinyl Paperwork Reduction Act (PRA) (44 Administrative practice and procedure,
pyrrolidinone copolymer. U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides
VIII. Other Considerations any special considerations under and pests, Reporting and recordkeeping
Executive Order 12898, entitled requirements.
A. Analytical Enforcement Methodology ‘‘Federal Actions to Address
Dated: September 7, 2018.
An analytical method is not required Environmental Justice in Minority
Populations and Low-Income Michael Goodis,
for enforcement purposes since the
Agency is establishing an exemption Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
1994). Pesticide Programs.
from the requirement of a tolerance
without any numerical limitation. Since tolerances and exemptions that Therefore, 40 CFR chapter I is
are established on the basis of a petition amended as follows:
B. International Residue Limits under FFDCA section 408(d), such as
In making its tolerance decisions, EPA the tolerance in this final rule, do not PART 180—[AMENDED]
seeks to harmonize U.S. tolerances with require the issuance of a proposed rule,
international standards whenever the requirements of the Regulatory ■ 1. The authority citation for part 180
possible, consistent with U.S. food Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
safety standards and agricultural seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
practices. EPA considers the This action directly regulates growers, ■ 2. In § 180.960, add alphabetically the
international maximum residue limits food processors, food handlers, and food polymer ‘‘Maltodextrin-vinyl
(MRLs) established by the Codex retailers, not States or tribes, nor does pyrrolidinone copolymer, minimum
Alimentarius Commission (Codex), as this action alter the relationships or
daltland on DSKBBV9HB2PROD with RULES
number average molecular weight (in
required by FFDCA section 408(b)(4). distribution of power and amu), 21,000’’ to the table to read as
The Codex Alimentarius is a joint responsibilities established by Congress follows:
United Nations Food and Agriculture in the preemption provisions of FFDCA
Organization/World Health section 408(n)(4). As such, the Agency § 180.960 Polymers; exemptions from the
Organization food standards program, has determined that this action will not requirement of a tolerance.
and it is recognized as an international have a substantial direct effect on States * * * * *
VerDate Sep<11>2014 17:04 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00034 Fmt 4700 Sfmt 4700 E:\FR\FM\26SER1.SGM 26SER1](https://thefederalregister.org/doc/83_FR_48739/page/3.svg)
![Federal Register / Vol. 83, No. 187 / Wednesday, September 26, 2018 / Rules and Regulations 48555
Polymer CAS No.
* * * * * * *
Maltodextrin-vinyl pyrrolidinone copolymer, minimum number average molecular weight (in amu), 21,000 ..................................... 1323833–56–2
* * * * * * *
[FR Doc. 2018–20968 Filed 9–25–18; 8:45 am] holidays. The telephone number for the OPP–2018–0264 in the subject line on
BILLING CODE 6560–50–P Public Reading Room is (202) 566–1744, the first page of your submission. All
and the telephone number for the OPP objections and requests for a hearing
Docket is (703) 305–5805. Please review must be in writing, and must be
ENVIRONMENTAL PROTECTION the visitor instructions and additional received by the Hearing Clerk on or
AGENCY information about the docket available before November 26, 2018. Addresses
at http://www.epa.gov/dockets. for mail and hand delivery of objections
40 CFR Part 180 and hearing requests are provided in 40
FOR FURTHER INFORMATION CONTACT:
[EPA–HQ–OPP–2018–0264; FRL–9983–22] Michael Goodis, Director, Registration CFR 178.25(b).
Division (7505P), Office of Pesticide In addition to filing an objection or
2-Propenoic Acid, Polymer With Butyl Programs, Environmental Protection hearing request with the Hearing Clerk
2-Propenoate, Ethenylbenzene and (1- Agency, 1200 Pennsylvania Ave. NW, as described in 40 CFR part 178, please
Methylethenyl) Benzene, Ammonium Washington, DC 20460–0001; main submit a copy of the filing (excluding
Salt; Tolerance Exemption telephone number: (703) 305–7090; any Confidential Business Information
email address: RDFRNotices@epa.gov. (CBI)) for inclusion in the public docket.
AGENCY: Environmental Protection
SUPPLEMENTARY INFORMATION:
Information not marked confidential
Agency (EPA).
pursuant to 40 CFR part 2 may be
ACTION: Final rule. I. General Information disclosed publicly by EPA without prior
SUMMARY: This regulation establishes an A. Does this action apply to me? notice. Submit the non-CBI copy of your
exemption from the requirement of a objection or hearing request, identified
tolerance for residues of 2-propenoic You may be potentially affected by by docket ID number EPA–HQ–OPP–
acid, polymer with butyl 2-propenoate, this action if you are an agricultural 2018–0264, by one of the following
ethenylbenzene and (1-methylethenyl) producer, food manufacturer, or methods.
benzene, ammonium salt; when used as pesticide manufacturer. The following • Federal eRulemaking Portal: http://
an inert ingredient in a pesticide list of North American Industrial www.regulations.gov. Follow the online
chemical formulation. Spring Trading Classification System (NAICS) codes is instructions for submitting comments.
Company on behalf of BASF not intended to be exhaustive, but rather Do not submit electronically any
Corporation submitted a petition to EPA provides a guide to help readers information you consider to be CBI or
under the Federal Food, Drug, and determine whether this document other information whose disclosure is
Cosmetic Act (FFDCA), requesting an applies to them. Potentially affected restricted by statute.
exemption from the requirement of a entities may include: • Mail: OPP Docket, Environmental
• Crop production (NAICS code 111). Protection Agency Docket Center (EPA/
tolerance. This regulation eliminates the
• Animal production (NAICS code DC), (28221T), 1200 Pennsylvania Ave.
need to establish a maximum
112). NW, Washington, DC 20460–0001.
permissible level for residues of 2-
• Food manufacturing (NAICS code • Hand Delivery: To make special
propenoic acid, polymer with butyl 2-
311). arrangements for hand delivery or
propenoate, ethenylbenzene and (1-
• Pesticide manufacturing (NAICS delivery of boxed information, please
methylethenyl) benzene, ammonium
code 32532). follow the instructions at http://
salt on food or feed commodities.
www.epa.gov/dockets/contacts.html.
DATES: This regulation is effective B. How can I get electronic access to
Additional instructions on
September 26, 2018. Objections and other related information?
commenting or visiting the docket,
requests for hearings must be received You may access a frequently updated along with more information about
on or before November 26, 2018, and electronic version of 40 CFR part 180 dockets generally, is available at http://
must be filed in accordance with the through the Government Printing www.epa.gov/dockets.
instructions provided in 40 CFR part Office’s e-CFR site at http://
178 (see also Unit I.C. of the www.ecfr.gov/cgi-bin/text-idx?&c=ecfr II. Background and Statutory Findings
SUPPLEMENTARY INFORMATION). &tpl=/ecfrbrowse/Title40/40tab_02.tpl. In the Federal Register of June 14,
ADDRESSES: The docket for this action, 2018 (83 FR 27743) (FRL–9978–41),
identified by docket identification (ID) C. Can I file an objection or hearing EPA issued a document pursuant to
number EPA–HQ–OPP–2018–0264, is request? FFDCA section 408, 21 U.S.C.
available at http://www.regulations.gov Under FFDCA section 408(g), 21 346a(d)(3), announcing the receipt of a
or at the Office of Pesticide Programs U.S.C. 346a, any person may file an pesticide petition (PP IN–11149) filed
Regulatory Public Docket (OPP Docket) objection to any aspect of this regulation by Spring Trading Company on behalf
in the Environmental Protection Agency and may also request a hearing on those of BASF Corporation, 100 Park Avenue,
daltland on DSKBBV9HB2PROD with RULES
Docket Center (EPA/DC), West William objections. You must file your objection Florham Park, New Jersey 07932. The
Jefferson Clinton Bldg., Rm. 3334, 1301 or request a hearing on this regulation petition requested that 40 CFR 180.960
Constitution Ave. NW, Washington, DC in accordance with the instructions be amended by establishing an
20460–0001. The Public Reading Room provided in 40 CFR part 178. To ensure exemption from the requirement of a
is open from 8:30 a.m. to 4:30 p.m., proper receipt by EPA, you must tolerance for residues of 2-propenoic
Monday through Friday, excluding legal identify docket ID number EPA–HQ– acid, polymer with butyl 2-propenoate,
VerDate Sep<11>2014 17:04 Sep 25, 2018 Jkt 244001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\FR\FM\26SER1.SGM 26SER1](https://thefederalregister.org/doc/83_FR_48739/page/4.svg)
Document Created: 2018-09-26 00:47:17
Document Modified: 2018-09-26 00:47:17
| 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 26, 2018. Objections and requests for hearings must be received on or before November 26, 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, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone | |
| FR Citation | 83 FR 48552 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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