80 FR 60545 - Butanedioic Acid, 2-Methylene-, Homopolymer, Sodium Salt; Inert Ingredient Tolerance Exemption
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 194 (October 7, 2015)
Federal Register Volume 80, Issue 194 (October 7, 2015)
| Page Range | 60545-60547 | |
| FR Document | 2015-25567 |
[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)] [Rules and Regulations] [Pages 60545-60547] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-25567] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2015-0395; FRL-9933-74] Butanedioic Acid, 2-Methylene-, Homopolymer, Sodium Salt; Inert Ingredient 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 butanedioic acid, 2-methylene-, homopolymer, sodium salt; when used as an inert ingredient in a pesticide chemical formulation. Itaconix Corporation 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 butanedioic acid, 2-methylene-, homopolymer, sodium salt on food or feed commodities. DATES: This regulation is effective October 7, 2015. Objections and requests for hearings must be received on or before December 7, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2015-0395, 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-2015-0395 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 December 7, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2015-0395, 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 July 17, 2015 (80 FR 42462) (FRL-9929- 13), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the receipt of a pesticide [[Page 60546]] petition (PP IN-10818) filed by Itaconix Corporation, 2 Marin Way, Stratham, NH 03885. The petition requested that 40 CFR 180.960 be amended by establishing an exemption from the requirement of a tolerance for residues of butanedioic acid, 2-methylene-, homopolymer, sodium salt; CAS Reg. No. 26099-89-8. 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). Butanedioic acid, 2-methylene-, homopolymer, sodium salt 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 3936 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. Thus, butanedioic acid, 2- methylene-, homopolymer, sodium salt 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 butanedioic acid, 2-methylene-, homopolymer, sodium salt. IV. Aggregate Exposures For the purposes of assessing potential exposure under this exemption, EPA considered that butanedioic acid, 2-methylene-, homopolymer, sodium salt 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 butanedioic acid, 2-methylene-, homopolymer, sodium salt is 3936 daltons. Generally, a polymer of this size would be poorly absorbed through the intact gastrointestinal tract or through intact human skin. Since butanedioic acid, 2-methylene-, homopolymer, sodium salt 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 butanedioic acid, 2-methylene-, homopolymer, sodium salt to share a common mechanism of toxicity with any other substances, and butanedioic acid, 2-methylene-, homopolymer, sodium salt does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that butanedioic acid, 2-methylene-, homopolymer, sodium salt 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 [[Page 60547]] 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 butanedioic acid, 2- methylene-, homopolymer, sodium salt, 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 butanedioic acid, 2-methylene-, homopolymer, sodium salt. VIII. Other Considerations A. Existing Exemptions From a Tolerance Not Available. 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 butanedioic acid, 2- methylene-, homopolymer, sodium salt. IX. Conclusion Accordingly, EPA finds that exempting residues of butanedioic acid, 2-methylene-, homopolymer, sodium salt 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 17, 2015. Susan Lewis, 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, alphabetically add ``Butanedioic acid, 2- methylene-, homopolymer, sodium salt, minimum number average molecular weight (in amu), 3936'' to the table to read as follows: Sec. [emsp14]180.960 Polymers; exemptions from the requirement of a tolerance. * * * * * ------------------------------------------------------------------------ Polymer CAS No. ------------------------------------------------------------------------ * * * * * Butanedioic acid, 2-methylene-, homopolymer, sodium salt, 26099-89-8 minimum number average molecular weight (in amu), 3936... * * * * * ------------------------------------------------------------------------ [FR Doc. 2015-25567 Filed 10-6-15; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Rules and Regulations 60545
EPA-APPROVED RHODE ISLAND REGULATIONS
State effective
State citation Title/subject EPA approval date Explanations
date
* * * * * * *
Air Pollution Control Sulfur Content of Fuels 6/26/2014 10/7/2015 [Insert Fed- Excluding Section 8.7 ‘‘Fuel Supply Shortages’’
Regulation 8. eral Register cita- which was not submitted by the State.
tion].
* * * * * * *
* * * * * holidays. The telephone number for the or request a hearing on this regulation
[FR Doc. 2015–25334 Filed 10–6–15; 8:45 am] Public Reading Room is (202) 566–1744, in accordance with the instructions
BILLING CODE 6560–50–P and the telephone number for the OPP provided in 40 CFR part 178. To ensure
Docket is (703) 305–5805. Please review proper receipt by EPA, you must
the visitor instructions and additional identify docket ID number EPA–HQ–
ENVIRONMENTAL PROTECTION information about the docket available OPP–2015–0395 in the subject line on
AGENCY at http://www.epa.gov/dockets. the first page of your submission. All
FOR FURTHER INFORMATION CONTACT: objections and requests for a hearing
40 CFR Part 180 must be in writing, and must be
Susan Lewis, Registration Division
[EPA–HQ–OPP–2015–0395; FRL–9933–74] (7505P), Office of Pesticide Programs, received by the Hearing Clerk on or
Environmental Protection Agency, 1200 before December 7, 2015. Addresses for
Butanedioic Acid, 2-Methylene-, Pennsylvania Ave. NW., Washington, mail and hand delivery of objections
Homopolymer, Sodium Salt; Inert DC 20460–0001; main telephone and hearing requests are provided in 40
Ingredient Tolerance Exemption number: (703) 305–7090; email address: CFR 178.25(b).
RDFRNotices@epa.gov. In addition to filing an objection or
AGENCY: Environmental Protection
hearing request with the Hearing Clerk
Agency (EPA). SUPPLEMENTARY INFORMATION:
as described in 40 CFR part 178, please
ACTION: Final rule. I. General Information submit a copy of the filing (excluding
SUMMARY: This regulation establishes an any Confidential Business Information
A. Does this action apply to me?
exemption from the requirement of a (CBI)) for inclusion in the public docket.
tolerance for residues of butanedioic You may be potentially affected by Information not marked confidential
acid, 2-methylene-, homopolymer, this action if you are an agricultural pursuant to 40 CFR part 2 may be
sodium salt; when used as an inert producer, food manufacturer, or disclosed publicly by EPA without prior
ingredient in a pesticide chemical pesticide manufacturer. The following notice. Submit the non-CBI copy of your
formulation. Itaconix Corporation list of North American Industrial objection or hearing request, identified
submitted a petition to EPA under the Classification System (NAICS) codes is by docket ID number EPA–HQ–OPP–
Federal Food, Drug, and Cosmetic Act not intended to be exhaustive, but rather 2015–0395, by one of the following
(FFDCA), requesting an exemption from provides a guide to help readers methods.
the requirement of a tolerance. This determine whether this document • Federal eRulemaking Portal: http://
regulation eliminates the need to applies to them. Potentially affected www.regulations.gov. Follow the online
establish a maximum permissible level entities may include: instructions for submitting comments.
for residues of butanedioic acid, 2- • Crop production (NAICS code 111). Do not submit electronically any
methylene-, homopolymer, sodium salt • Animal production (NAICS code information you consider to be CBI or
on food or feed commodities. 112). other information whose disclosure is
• Food manufacturing (NAICS code restricted by statute.
DATES: This regulation is effective
311). • Mail: OPP Docket, Environmental
October 7, 2015. Objections and • Pesticide manufacturing (NAICS Protection Agency Docket Center (EPA/
requests for hearings must be received code 32532). DC), (28221T), 1200 Pennsylvania Ave.
on or before December 7, 2015, and NW., Washington, DC 20460–0001.
must be filed in accordance with the B. How can I get electronic access to
• Hand Delivery: To make special
instructions provided in 40 CFR part other related information?
arrangements for hand delivery or
178 (see also Unit I.C. of the You may access a frequently updated delivery of boxed information, please
SUPPLEMENTARY INFORMATION). electronic version of 40 CFR part 180 follow the instructions at http://
ADDRESSES: The docket for this action, through the Government Printing www.epa.gov/dockets/contacts.html.
identified by docket identification (ID) Office’s e-CFR site at http:// Additional instructions on
number EPA–HQ–OPP–2015–0395, is www.ecfr.gov/cgi-bin/text- commenting or visiting the docket,
available at http://www.regulations.gov idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ along with more information about
or at the Office of Pesticide Programs 40tab_02.tpl. dockets generally, is available at
asabaliauskas on DSK5VPTVN1PROD with RULES
Regulatory Public Docket (OPP Docket) http://www.epa.gov/dockets.
in the Environmental Protection Agency C. Can I file an objection or hearing
Docket Center (EPA/DC), West William request? II. Background and Statutory Findings
Jefferson Clinton Bldg., Rm. 3334, 1301 Under FFDCA section 408(g), 21 In the Federal Register of July 17,
Constitution Ave. NW., Washington, DC U.S.C. 346a, any person may file an 2015 (80 FR 42462) (FRL–9929–13),
20460–0001. The Public Reading Room objection to any aspect of this regulation EPA issued a document pursuant to
is open from 8:30 a.m. to 4:30 p.m., and may also request a hearing on those FFDCA section 408, 21 U.S.C. 346a,
Monday through Friday, excluding legal objections. You must file your objection announcing the receipt of a pesticide
VerDate Sep<11>2014 17:26 Oct 06, 2015 Jkt 238001 PO 00000 Frm 00033 Fmt 4700 Sfmt 4700 E:\FR\FM\07OCR1.SGM 07OCR1](https://thefederalregister.org/doc/80_FR_60739/page/1.svg)
![Federal Register / Vol. 80, No. 194 / Wednesday, October 7, 2015 / Rules and Regulations 60547
additional tenfold margin of safety for 2-methylene-, homopolymer, sodium to this action. In addition, this action
infants and children in the case of salt from the requirement of a tolerance does not impose any enforceable duty or
threshold effects to account for prenatal will be safe. contain any unfunded mandate as
and postnatal toxicity and the described under Title II of the Unfunded
X. Statutory and Executive Order
completeness of the data base unless Mandates Reform Act (UMRA) (2 U.S.C.
Reviews
EPA concludes that a different margin of 1501 et seq.).
safety will be safe for infants and This action establishes a tolerance This action does not involve any
children. Due to the expected low under FFDCA section 408(d) in technical standards that would require
toxicity of butanedioic acid, response to a petition submitted to the Agency consideration of voluntary
2-methylene-, homopolymer, sodium Agency. The Office of Management and consensus standards pursuant to section
salt, EPA has not used a safety factor Budget (OMB) has exempted these types 12(d) of the National Technology
analysis to assess the risk. For the same of actions from review under Executive Transfer and Advancement Act
reasons the additional tenfold safety Order 12866, entitled ‘‘Regulatory (NTTAA) (15 U.S.C. 272 note).
factor is unnecessary. Planning and Review’’ (58 FR 51735,
October 4, 1993). Because this action XI. Congressional Review Act
VII. Determination of Safety has been exempted from review under Pursuant to the Congressional Review
Based on the conformance to the Executive Order 12866, this action is Act (5 U.S.C. 801 et seq.), EPA will
criteria used to identify a low-risk not subject to Executive Order 13211, submit a report containing this rule and
polymer, EPA concludes that there is a entitled ‘‘Actions Concerning other required information to the U.S.
reasonable certainty of no harm to the Regulations That Significantly Affect Senate, the U.S. House of
U.S. population, including infants and Energy Supply, Distribution, or Use’’ (66 Representatives, and the Comptroller
children, from aggregate exposure to FR 28355, May 22, 2001) or Executive General of the United States prior to
residues of butanedioic acid, Order 13045, entitled ‘‘Protection of publication of the rule in the Federal
2-methylene-, homopolymer, sodium Children from Environmental Health Register. This action is not a ‘‘major
salt. Risks and Safety Risks’’ (62 FR 19885, rule’’ as defined by 5 U.S.C. 804(2).
April 23, 1997). This action does not
VIII. Other Considerations List of Subjects in 40 CFR Part 180
contain any information collections
A. Existing Exemptions From a subject to OMB approval under the Environmental protection,
Tolerance Paperwork Reduction Act (PRA) (44 Administrative practice and procedure,
Not Available. U.S.C. 3501 et seq.), nor does it require Agricultural commodities, Pesticides
any special considerations under and pests, Reporting and recordkeeping
B. Analytical Enforcement Methodology Executive Order 12898, entitled requirements.
An analytical method is not required ‘‘Federal Actions to Address
Dated: September 17, 2015.
for enforcement purposes since the Environmental Justice in Minority
Populations and Low-Income Susan Lewis,
Agency is establishing an exemption
from the requirement of a tolerance Populations’’ (59 FR 7629, February 16, Director, Registration Division, Office of
1994). Pesticide Programs.
without any numerical limitation.
Since tolerances and exemptions that Therefore, 40 CFR chapter I is
C. International Residue Limits are established on the basis of a petition amended as follows:
In making its tolerance decisions, EPA under FFDCA section 408(d), such as
seeks to harmonize U.S. tolerances with the tolerance in this final rule, do not PART 180—[AMENDED]
international standards whenever require the issuance of a proposed rule,
possible, consistent with U.S. food the requirements of the Regulatory ■ 1. The authority citation for part 180
safety standards and agricultural Flexibility Act (RFA) (5 U.S.C. 601 et continues to read as follows:
practices. EPA considers the seq.), do not apply. Authority: 21 U.S.C. 321(q), 346a and 371.
international maximum residue limits This action directly regulates growers,
food processors, food handlers, and food ■ 2. In § 180.960, alphabetically add
(MRLs) established by the Codex ‘‘Butanedioic acid, 2-methylene-,
Alimentarius Commission (Codex), as retailers, not States or tribes, nor does
this action alter the relationships or homopolymer, sodium salt, minimum
required by FFDCA section 408(b)(4). number average molecular weight (in
The Codex Alimentarius is a joint distribution of power and
responsibilities established by Congress amu), 3936’’ to the table to read as
United Nations Food and Agriculture follows:
Organization/World Health in the preemption provisions of FFDCA
Organization food standards program, section 408(n)(4). As such, the Agency § 180.960 Polymers; exemptions from the
and it is recognized as an international has determined that this action will not requirement of a tolerance.
food safety standards-setting have a substantial direct effect on States * * * * *
organization in trade agreements to or tribal governments, on the
which the United States is a party. EPA relationship between the national Polymer CAS No.
may establish a tolerance that is government and the States or tribal
different from a Codex MRL; however, governments, or on the distribution of
power and responsibilities among the * * * * *
FFDCA section 408(b)(4) requires that Butanedioic acid, 2-methylene-,
EPA explain the reasons for departing various levels of government or between
asabaliauskas on DSK5VPTVN1PROD with RULES
the Federal Government and Indian homopolymer, sodium salt,
from the Codex level. minimum number average
The Codex has not established a MRL tribes. Thus, the Agency has determined molecular weight (in amu),
for butanedioic acid, 2-methylene-, that Executive Order 13132, entitled 3936 ...................................... 26099–89–8
homopolymer, sodium salt. ‘‘Federalism’’ (64 FR 43255, August 10,
1999) and Executive Order 13175, * * * * *
IX. Conclusion entitled ‘‘Consultation and Coordination
Accordingly, EPA finds that with Indian Tribal Governments’’ (65 FR [FR Doc. 2015–25567 Filed 10–6–15; 8:45 am]
exempting residues of butanedioic acid, 67249, November 9, 2000) do not apply BILLING CODE 6560–50–P
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Document Created: 2015-12-15 08:49:47
Document Modified: 2015-12-15 08:49:47
| 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 October 7, 2015. Objections and requests for hearings must be received on or before December 7, 2015, 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 | 80 FR 60545 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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