81 FR 47042 - 2-Propenoic Acid, Butyl Ester, Polymer With Ethenyl Acetate and Sodium Ethenesulfonate; Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 81, Issue 139 (July 20, 2016)
Federal Register Volume 81, Issue 139 (July 20, 2016)
| Page Range | 47042-47045 | |
| FR Document | 2016-17165 |
[Federal Register Volume 81, Number 139 (Wednesday, July 20, 2016)] [Rules and Regulations] [Pages 47042-47045] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17165] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0149; FRL-9948-64] 2-Propenoic Acid, Butyl Ester, Polymer With Ethenyl Acetate and Sodium Ethenesulfonate; Tolerance Exemption AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate (CAS Reg. No. 66573-43- 1) when used as an inert ingredient in a pesticide chemical formulation. Celanese Ltd submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate on food or feed commodities. DATES: This regulation is effective July 20, 2016. Objections and requests for hearings must be received on or before September 19, 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-2016-0149, 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: Susan Lewis, 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-2016-0149 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 September 19, 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-2016-0149, 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 and Statutory Findings In the Federal Register of April 25, 2016 (81 FR 24044) (FRL-9944- 86), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide petition (PP IN-10900) filed by Celanese Ltd, 222 W Las Colinas Blvd., Suite 900N, Irving, TX 75039. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate (CAS No. 66573-43-1). 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 [[Page 47043]] 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). 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate 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. 7. The polymer does not contain certain perfluoroalkyl moieties consisting of a CF3- or longer chain length as specified 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). 8. The polymer's number average MW of 20,500 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, 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate 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 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate 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 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate is 20,500 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate 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 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate to share a common mechanism of toxicity with any other substances, and 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate 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. 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 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate, EPA has not used a safety factor analysis to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary. [[Page 47044]] 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 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate. VIII. Other Considerations A. Existing Exemptions From a Tolerance There are no existing exemptions from a tolerance for 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate. B. 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. C. 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 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate. IX. Conclusion Accordingly, EPA finds that exempting residues of 2-propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate 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: July 11, 2016. Daniel Kenny, Acting 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 ``2-Propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate, minimum number average molecular weight (in amu), 20,500'' in the table to read as follows: Sec. 180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * * * 2-Propenoic acid, butyl ester, polymer with ethenyl 66573-43-1 acetate and sodium ethenesulfonate, minimum number average molecular weight (in amu), 20,500.............. [[Page 47045]] * * * * * * * ------------------------------------------------------------------------ [FR Doc. 2016-17165 Filed 7-19-16; 8:45 am] BILLING CODE 6560-50-P
![47042 Federal Register / Vol. 81, No. 139 / Wednesday, July 20, 2016 / Rules and Regulations
This action finding that Maryland has 20460–0001. The Public Reading Room before September 19, 2016. Addresses
failed to submit a CAA section is open from 8:30 a.m. to 4:30 p.m., for mail and hand delivery of objections
110(a)(2)(D)(I)(I) SIP may not be Monday through Friday, excluding legal and hearing requests are provided in 40
challenged later in proceedings to holidays. The telephone number for the CFR 178.25(b).
enforce its requirements. (See section Public Reading Room is (202) 566–1744, In addition to filing an objection or
307(b)(2).) and the telephone number for the OPP hearing request with the Hearing Clerk
Docket is (703) 305–5805. Please review as described in 40 CFR part 178, please
List of Subjects in 40 CFR Part 52 submit a copy of the filing (excluding
the visitor instructions and additional
Environmental protection, Air information about the docket available any Confidential Business Information
pollution control, Intergovernmental at http://www.epa.gov/dockets. (CBI)) for inclusion in the public docket.
relations, Ozone. FOR FURTHER INFORMATION CONTACT: Information not marked confidential
Dated: July 8, 2016. Susan Lewis, Registration Division pursuant to 40 CFR part 2 may be
Shawn M. Garvin, (7505P), Office of Pesticide Programs, disclosed publicly by EPA without prior
Environmental Protection Agency, 1200 notice. Submit the non-CBI copy of your
Regional Administrator, Region III.
Pennsylvania Ave. NW., Washington, objection or hearing request, identified
[FR Doc. 2016–17057 Filed 7–19–16; 8:45 am]
DC 20460–0001; main telephone by docket ID number EPA–HQ–OPP–
BILLING CODE 6560–50–P 2016–0149, by one of the following
number: (703) 305–7090; email address:
RDFRNotices@epa.gov. methods.
• Federal eRulemaking Portal: http://
ENVIRONMENTAL PROTECTION SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online
AGENCY 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–2016–0149; FRL–9948–64] You may be potentially affected by other information whose disclosure is
this action if you are an agricultural restricted by statute.
2-Propenoic Acid, Butyl Ester, Polymer producer, food manufacturer, or • Mail: OPP Docket, Environmental
With Ethenyl Acetate and Sodium pesticide manufacturer. The following Protection Agency Docket Center (EPA/
Ethenesulfonate; Tolerance Exemption list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
AGENCY: Environmental Protection Classification System (NAICS) codes is NW., Washington, DC 20460–0001.
Agency (EPA). not intended to be exhaustive, but rather • Hand Delivery: To make special
provides a guide to help readers arrangements for hand delivery or
ACTION: Final rule.
determine whether this document delivery of boxed information, please
SUMMARY: This regulation establishes an applies to them. Potentially affected follow the instructions at http://
exemption from the requirement of a entities may include: www.epa.gov/dockets/contacts.html.
tolerance for residues of 2-propenoic • Crop production (NAICS code 111). Additional instructions on
acid, butyl ester, polymer with ethenyl • Animal production (NAICS code commenting or visiting the docket,
acetate and sodium ethenesulfonate 112). along with more information about
(CAS Reg. No. 66573–43–1) when used • Food manufacturing (NAICS code dockets generally, is available at http://
as an inert ingredient in a pesticide 311). www.epa.gov/dockets.
chemical formulation. Celanese Ltd • Pesticide manufacturing (NAICS
II. Background and Statutory Findings
submitted a petition to EPA under the code 32532).
Federal Food, Drug, and Cosmetic Act In the Federal Register of April 25,
B. How can I get electronic access to 2016 (81 FR 24044) (FRL–9944–86),
(FFDCA), requesting an exemption from other related information?
the requirement of a tolerance. This EPA issued a document pursuant to
regulation eliminates the need to You may access a frequently updated FFDCA section 408, 21 U.S.C. 346a,
establish a maximum permissible level electronic version of 40 CFR part 180 announcing the receipt of a pesticide
for residues of 2-propenoic acid, butyl through the Government Printing petition (PP IN–10900) filed by Celanese
ester, polymer with ethenyl acetate and Office’s e-CFR site at http:// Ltd, 222 W Las Colinas Blvd., Suite
sodium ethenesulfonate on food or feed www.ecfr.gov/cgi-bin/text- 900N, Irving, TX 75039. The petition
commodities. idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ requested that 40 CFR 180.960 be
40tab_02.tpl. amended by establishing an exemption
DATES: This regulation is effective July
from the requirement of a tolerance for
20, 2016. Objections and requests for C. Can I file an objection or hearing residues of 2-propenoic acid, butyl
hearings must be received on or before request? ester, polymer with ethenyl acetate and
September 19, 2016, and must be filed Under FFDCA section 408(g), 21 sodium ethenesulfonate (CAS No.
in accordance with the instructions U.S.C. 346a, any person may file an 66573–43–1). That document included a
provided in 40 CFR part 178 (see also objection to any aspect of this regulation summary of the petition prepared by the
Unit I.C. of the SUPPLEMENTARY and may also request a hearing on those petitioner and solicited comments on
INFORMATION). objections. You must file your objection the petitioner’s request. The Agency did
ADDRESSES: The docket for this action, or request a hearing on this regulation not receive any comments.
identified by docket identification (ID) in accordance with the instructions Section 408(c)(2)(A)(i) of FFDCA
number EPA–HQ–OPP–2016–0149, is provided in 40 CFR part 178. To ensure allows EPA to establish an exemption
available at http://www.regulations.gov proper receipt by EPA, you must from the requirement for a tolerance (the
rmajette on DSK2TPTVN1PROD with RULES
or at the Office of Pesticide Programs identify docket ID number EPA–HQ– legal limit for a pesticide chemical
Regulatory Public Docket (OPP Docket) OPP–2016–0149 in the subject line on residue in or on a food) only if EPA
in the Environmental Protection Agency the first page of your submission. All determines that the exemption is ‘‘safe.’’
Docket Center (EPA/DC), West William objections and requests for a hearing Section 408(c)(2)(A)(ii) of FFDCA
Jefferson Clinton Bldg., Rm. 3334, 1301 must be in writing, and must be defines ‘‘safe’’ to mean that ‘‘there is a
Constitution Ave. NW., Washington, DC received by the Hearing Clerk on or reasonable certainty that no harm will
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VII. Determination of Safety X. Statutory and Executive Order 1999) and Executive Order 13175,
Based on the conformance to the Reviews entitled ‘‘Consultation and Coordination
criteria used to identify a low-risk This action establishes a tolerance with Indian Tribal Governments’’ (65 FR
polymer, EPA concludes that there is a under FFDCA section 408(d) in 67249, November 9, 2000) do not apply
reasonable certainty of no harm to the response to a petition submitted to the to this action. In addition, this action
U.S. population, including infants and Agency. The Office of Management and does not impose any enforceable duty or
children, from aggregate exposure to Budget (OMB) has exempted these types contain any unfunded mandate as
residues of 2-propenoic acid, butyl of actions from review under Executive described under Title II of the Unfunded
ester, polymer with ethenyl acetate and Order 12866, entitled ‘‘Regulatory Mandates Reform Act (UMRA) (2 U.S.C.
sodium ethenesulfonate. Planning and Review’’ (58 FR 51735, 1501 et seq.).
VIII. Other Considerations October 4, 1993). Because this action This action does not involve any
has been exempted from review under technical standards that would require
A. Existing Exemptions From a Executive Order 12866, this action is Agency consideration of voluntary
Tolerance not subject to Executive Order 13211, consensus standards pursuant to section
There are no existing exemptions entitled ‘‘Actions Concerning 12(d) of the National Technology
from a tolerance for 2-propenoic acid, Regulations That Significantly Affect Transfer and Advancement Act
butyl ester, polymer with ethenyl Energy Supply, Distribution, or Use’’ (66 (NTTAA) (15 U.S.C. 272 note).
acetate and sodium ethenesulfonate. FR 28355, May 22, 2001) or Executive XI. Congressional Review Act
Order 13045, entitled ‘‘Protection of
B. Analytical Enforcement Methodology
Children from Environmental Health Pursuant to the Congressional Review
An analytical method is not required Risks and Safety Risks’’ (62 FR 19885, Act (5 U.S.C. 801 et seq.), EPA will
for enforcement purposes since the April 23, 1997). This action does not submit a report containing this rule and
Agency is establishing an exemption contain any information collections other required information to the U.S.
from the requirement of a tolerance subject to OMB approval under the Senate, the U.S. House of
without any numerical limitation. Paperwork Reduction Act (PRA) (44 Representatives, and the Comptroller
C. International Residue Limits U.S.C. 3501 et seq.), nor does it require General of the United States prior to
any special considerations under publication of the rule in the Federal
In making its tolerance decisions, EPA Executive Order 12898, entitled Register. This action is not a ‘‘major
seeks to harmonize U.S. tolerances with ‘‘Federal Actions to Address rule’’ as defined by 5 U.S.C. 804(2).
international standards whenever Environmental Justice in Minority
possible, consistent with U.S. food Populations and Low-Income List of Subjects in 40 CFR Part 180
safety standards and agricultural Populations’’ (59 FR 7629, February 16,
practices. EPA considers the Environmental protection,
1994). Administrative practice and procedure,
international maximum residue limits
Since tolerances and exemptions that Agricultural commodities, Pesticides
(MRLs) established by the Codex
are established on the basis of a petition and pests, Reporting and recordkeeping
Alimentarius Commission (Codex), as
under FFDCA section 408(d), such as requirements.
required by FFDCA section 408(b)(4).
the tolerance in this final rule, do not
The Codex Alimentarius is a joint Dated: July 11, 2016.
require the issuance of a proposed rule,
United Nations Food and Agriculture Daniel Kenny,
the requirements of the Regulatory
Organization/World Health Acting Director, Registration Division, Office
Organization food standards program, Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply. of Pesticide Programs.
and it is recognized as an international
food safety standards-setting This action directly regulates growers, Therefore, 40 CFR chapter I is
organization in trade agreements to food processors, food handlers, and food amended as follows:
which the United States is a party. EPA retailers, not States or tribes, nor does
may establish a tolerance that is this action alter the relationships or PART 180—[AMENDED]
different from a Codex MRL; however, distribution of power and
FFDCA section 408(b)(4) requires that responsibilities established by Congress ■ 1. The authority citation for part 180
EPA explain the reasons for departing in the preemption provisions of FFDCA continues to read as follows:
from the Codex level. section 408(n)(4). As such, the Agency
Authority: 21 U.S.C. 321(q), 346a and 371.
The Codex has not established a MRL has determined that this action will not
for 2-propenoic acid, butyl ester, have a substantial direct effect on States ■ 2. In § 180.960, add alphabetically the
polymer with ethenyl acetate and or tribal governments, on the polymer ‘‘2-Propenoic acid, butyl ester,
sodium ethenesulfonate. relationship between the national polymer with ethenyl acetate and
government and the States or tribal sodium ethenesulfonate, minimum
IX. Conclusion governments, or on the distribution of number average molecular weight (in
Accordingly, EPA finds that power and responsibilities among the amu), 20,500’’ in the table to read as
exempting residues of 2-propenoic acid, various levels of government or between follows:
butyl ester, polymer with ethenyl the Federal Government and Indian
acetate and sodium ethenesulfonate tribes. Thus, the Agency has determined § 180.960 Polymers; exemptions from the
from the requirement of a tolerance will that Executive Order 13132, entitled requirement of a tolerance.
be safe. ‘‘Federalism’’ (64 FR 43255, August 10, * * * * *
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Polymer CAS No.
* * * * * * *
2-Propenoic acid, butyl ester, polymer with ethenyl acetate and sodium ethenesulfonate, minimum number average molecular
weight (in amu), 20,500 ................................................................................................................................................................... 66573–43–1
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Polymer CAS No.
* * * * * * *
[FR Doc. 2016–17165 Filed 7–19–16; 8:45 am] II. Summary of Errors in the adopted subject to notice and comment
BILLING CODE 6560–50–P Regulations Text procedures in the Medicaid and
On page 27896 of the Medicaid and Children’s Health Insurance Program
Children’s Health Insurance Program (CHIP) Programs; Medicaid Managed
(CHIP) Programs; Medicaid Managed Care, CHIP Delivered in Managed Care,
DEPARTMENT OF HEALTH AND Care, CHIP Delivered in Managed Care, and Revisions Related to Third Party
HUMAN SERVICES and Revisions Related to Third Party Liability final rule. As a result, the
Liability final rule, we made a technical corrections made through this correcting
Centers for Medicare & Medicaid document are intended to ensure that
Services error in the regulation text of § 457.10.
In this paragraph, we inadvertently the Medicaid and Children’s Health
omitted an amendatory instruction to Insurance Program (CHIP) Programs;
42 CFR Part 457 Medicaid Managed Care, CHIP
add the definition of ‘‘Federally
Qualified HMO’’ in alphabetical order. Delivered in Managed Care, and
[CMS–2390–F2] Revisions Related to Third Party
Accordingly, we are revising the
amendatory instruction for § 457.10 to Liability final rule accurately reflects
RIN–0938–AS25 add this definition as it was published the policies adopted in that rule.
in the May 6, 2016 Federal Register. Even if this were a rulemaking to
Medicaid and Children’s Health which the notice and comment and
Insurance Program (CHIP) Programs; III. Waiver of Proposed Rulemaking delayed effective date requirements
Medicaid Managed Care, CHIP and Delay in Effective Date applied, we find that there is good cause
Delivered in Managed Care, and Under 5 U.S.C. 553(b) of the to waive such requirements.
Revisions Related to Third Party Administrative Procedure Act (APA), Undertaking further notice and
Liability; Correcting Amendment the agency is required to publish a comment procedures to incorporate the
AGENCY: Centers for Medicare & notice of the proposed rule in the corrections in this document into the
Medicaid Services (CMS), HHS. Federal Register before the provisions Medicaid and Children’s Health
of a rule take effect. In addition, section Insurance Program (CHIP) Programs;
ACTION: Final rule; correcting
553(d) of the APA mandates a 30-day Medicaid Managed Care, CHIP
amendment. Delivered in Managed Care, and
delay in effective date after issuance or
SUMMARY: This document corrects a publication of a rule. Sections 553(b)(B) Revisions Related to Third Party
technical error that appeared in the final and 553(d)(3) of the APA provide for Liability final rule or delaying the
rule published in the May 6, 2016 exceptions from the APA notice and effective date of the corrections would
Federal Register (81 FR 27498 through comment, and delay in effective date be contrary to the public interest
27901) entitled, ‘‘Medicaid and requirements. Section 553(b)(B) of the because it is in the public interest to
Children’s Health Insurance Program APA authorizes an agency to dispense ensure that the Medicaid and Children’s
(CHIP) Programs; Medicaid Managed with normal notice and comment Health Insurance Program (CHIP)
Care, CHIP Delivered in Managed Care, rulemaking procedures for good cause if Programs; Medicaid Managed Care,
and Revisions Related to Third Party the agency makes a finding that the CHIP Delivered in Managed Care, and
Liability.’’ The effective date for the rule notice and comment process is Revisions Related to Third Party
was July 5, 2016. impracticable, unnecessary, or contrary Liability final rule accurately reflects
to the public interest; and includes a our final policies as soon as possible
DATES: Effective Date: This correcting
statement of the finding and the reasons following the date they take effect.
document is effective July 18, 2016.
for it in the notice. In addition, section Further, such procedures would be
Applicability Date: The corrections
553(d)(3) of the APA allows the agency unnecessary, because we are not altering
indicated in this document are
to avoid the 30-day delay in effective the payment methodologies or policies
applicable beginning July 5, 2016.
date where such delay is contrary to the or making any substantive revision to
FOR FURTHER INFORMATION CONTACT: public interest and the agency includes the description of the definition as
Melissa Williams, (410) 786–4435, in the rule a statement of the finding proposed or purported to be finalized in
CHIP. and the reasons for it. the preamble of the final rule, but
SUPPLEMENTARY INFORMATION: In our view, this correcting document rather, we are simply correcting the
does not constitute a rulemaking that Federal Register document to reflect the
I. Background would be subject to these requirements. policies that we previously proposed,
In FR Doc. 2016–09581 (81 FR 27498 This document merely corrects received comment on, and subsequently
through 27901), the final rule entitled, technical errors in the Medicaid and finalized. This correcting document is
‘‘Medicaid and Children’s Health Children’s Health Insurance Program intended solely to ensure that the
Insurance Program (CHIP) Programs; (CHIP) Programs; Medicaid Managed Medicaid and Children’s Health
Medicaid Managed Care, CHIP Care, CHIP Delivered in Managed Care, Insurance Program (CHIP) Programs;
rmajette on DSK2TPTVN1PROD with RULES
Delivered in Managed Care, and and Revisions Related to Third Party Medicaid Managed Care, CHIP
Revisions Related to Third Party Liability final rule. The corrections Delivered in Managed Care, and
Liability’’ there was a technical error contained in this document are Revisions Related to Third Party
that is identified and corrected in this consistent with, and do not make Liability final rule accurately reflects
correcting document. The correction is substantive changes to, the policies and these policies. For these reasons, we
applicable as of July 5, 2016. payment methodologies that were believe there is good cause to waive the
VerDate Sep<11>2014 14:53 Jul 19, 2016 Jkt 238001 PO 00000 Frm 00045 Fmt 4700 Sfmt 4700 E:\FR\FM\20JYR1.SGM 20JYR1](https://thefederalregister.org/doc/81_FR_47181/page/4.svg)
Document Created: 2018-02-08 07:57:17
Document Modified: 2018-02-08 07:57:17
| 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 July 20, 2016. Objections and requests for hearings must be received on or before September 19, 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 | Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone | |
| FR Citation | 81 FR 47042 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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