83 FR 5717 - Zoxamide; Pesticide Tolerances
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 83, Issue 28 (February 9, 2018)
Federal Register Volume 83, Issue 28 (February 9, 2018)
| Page Range | 5717-5720 | |
| FR Document | 2018-02668 |
[Federal Register Volume 83, Number 28 (Friday, February 9, 2018)] [Rules and Regulations] [Pages 5717-5720] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-02668] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2016-0681; FRL-9972-69] Zoxamide; Pesticide Tolerances AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes tolerances for residues of zoxamide in or on banana. Gowan Company, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective February 9, 2018. Objections and requests for hearings must be received on or before April 10, 2018, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0681, 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 L. Goodis, P.E., Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov. 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 EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0681 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 April 10, 2018. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b). In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0681, 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 [[Page 5718]] 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. Summary of Petitioned-For Tolerance In the Federal Register of June 8, 2017 (82 FR 26641) (FRL-9661- 14), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 6E8524) by Gowan Company, LLC, P.O. Box 556, Yuma, AZ 85366. The petition requested that 40 CFR 180.567 be amended by establishing a tolerance for residues of the fungicide zoxamide (3, 5-dichloro-N-(3- chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide), in or on banana at 0.3 parts per million (ppm). That document referenced a summary of the petition prepared by Gowan Company, LLC, the registrant, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. EPA's response is discussed in Unit IV.C. Based upon review of the data supporting the petition, EPA has determined that a tolerance of 0.20 ppm on banana is appropriate rather than the petitioned-for 0.3 ppm tolerance. The reason for this change is explained in Unit IV.D. III. Aggregate Risk Assessment and Determination of Safety Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to ``ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .'' Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for zoxamide including exposure resulting from the import tolerance established by this action. A. Risk Assessment In the Federal Register of March 8, 2016 (81 FR 12011) (FRL-9942- 18), EPA established tolerances for residues of zoxamide in or on several commodities. Because much of the safety assessment of zoxamide for the current action remains the same, EPA is incorporating several aspects of that previous rule and relying in part upon the findings made in the March 8, 2016 final rule in support of this action. A summary of the toxicological profile and endpoints used for human risk assessment is discussed in Units III.A. and III.B of the March 8, 2016 final rule. In evaluating dietary exposure for this action, EPA considered exposure under the petitioned-for tolerances as well as all existing zoxamide tolerances in 40 CFR 180.567. The residue data used for the acute and chronic dietary exposure assessments have not changed since the assessment supporting the March 8, 2016 final rule, except to incorporate the exposure associated with the tolerance on banana, for which the Agency assumed tolerance-level residues, default processing factors, and 100 percent crop treated. For a summary of how EPA assessed these dietary exposures, see Unit III.C.1 of the March 8, 2016 final rule. In addition, because there is no U.S. registration associated with the use of zoxamide on banana, the estimated drinking water exposures reported in the 2016 final rule remain the same for this rule. A summary of EPA's assessment of drinking water exposure is discussed in Unit III.C.2. of the March 8, 2016 final rule. Similarly, the Agency's assessment of cumulative risks remains the same as in the March 8, 2016 final rule. Because there have been no changes to the potential for prenatal and postnatal toxicity or in the completeness of data with respect to toxicity and exposure, EPA has determined that reliable data show the safety of infants and children would be adequately protected if the additional tenfold (10X) margin of safety required under section 408(b)(2)(C) (``FQPA safety factor'') were reduced to 1X. A summary of EPA's rationale for this determination is discussed in Unit III.D. of the March 8, 2016 final rule. B. Determination of Safety EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population-adjusted dose (aPAD) and chronic population-adjusted dose (cPAD). Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure exists. No acute effects were identified in the toxicological studies for zoxamide; therefore, a quantitative acute dietary exposure assessment is unnecessary. The chronic dietary risk is 1.8% of the chronic population adjusted dose (cPAD) for the general U.S. population and 6.4% of the cPAD for children 1 to 2 years old, the population subgroup with the highest estimated chronic dietary exposure to zoxamide. The Agency level of concern are percentage numbers greater than 100% of the cPAD. Because there are no existing or proposed residential uses for zoxamide, there are no exposures expected via the residential exposure pathway. Therefore, all aggregate risk estimates are expected to be equivalent only to dietary (food and drinking water) risk estimates mentioned above. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to zoxamide residues. For a detailed discussion of the aggregate risk assessments and determination of safety for these tolerances, please refer both to the March 8, 2016 final rule and its supporting documents, available at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2014-0922, and to the risk assessment for this current action ``Zoxamide: Human Health Risk Assessment for the Petition for a Tolerance Without U.S. Registration for Residues in/on Banana.'' in docket ID number EPA-HQ- OPP-2016-0681. IV. Other Considerations A. Analytical Enforcement Methodology A gas chromatography/mass selective detection (GC/MSD) method, modified Rohm and Haas Method #34-99-85, was previously submitted and concurrently revalidated with the submission of the current petition for the determination of residues of zoxamide in/on samples of banana. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305- [[Page 5719]] 2905; email address: residuemethods@epa.gov. 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 zoxamide. C. Response to Comments One comment was received from an anonymous respondent. The comment is general to all pesticides and is against tolerances being approved for any chemical on any commodity. Although the Agency recognizes that some individuals believe that no residue of pesticides should be allowed in or on food, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) authorizes the establishment of pesticide tolerances or exemptions where the Agency determines that tolerance or exemption meets the safety standard imposed by the statute. EPA has sufficient data to support a safety determination for the tolerance for residues of zoxamide in or on banana. The commenter provided no additional information supporting a determination that the exemption is not safe. D. Revisions to Petitioned-For Tolerances The Agency is establishing a tolerance for residues of zoxamide in or on banana at 0.20 ppm, which is lower than the 0.30 ppm tolerance requested. This is because there is a difference between how the petitioner calculated the proposed tolerance and how the Agency calculates the tolerance. The 0.20 ppm tolerance being set on banana was calculated using the Organization for Economic Cooperation and Development (OECD) tolerance calculation procedures and available field-trial residue data. The field-trial data on unbagged, whole fruit banana residues with a 0-day pre-harvest interval (PHI) were used from each field trial to calculate the tolerance. V. Conclusion Therefore, a tolerance is established for residues of zoxamide, (3, 5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4- methylbenzamide), in or on banana at 0.20 ppm. VI. 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); Executive Order 13045, entitled ``Protection of Children from Environmental Health Risks and Safety Risks'' (62 FR 19885, April 23, 1997); or Executive Order 13771, entitled ``Reducing Regulations and Controlling Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any special considerations under Executive Order 12898, entitled ``Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations'' (59 FR 7629, February 16, 1994). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the 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). VII. 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: January 23, 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. 180.567, add alphabetically the entry ``Banana'' to the table in paragraph (a) and add footnote 1 to the table to read as follows: Sec. 180.567 Zoxamide; tolerances for residues. (a) * * * (1) * * * [[Page 5720]] ------------------------------------------------------------------------ Parts per Commodity million ------------------------------------------------------------------------ Banana 1.................................................... 0.20 * * * * * ------------------------------------------------------------------------ 1 There are no U.S. registrations allowing use of zoxamide on banana as of February 9, 2018. * * * * * [FR Doc. 2018-02668 Filed 2-8-18; 8:45 am] BILLING CODE 6560-50-P
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VII. Congressional Review Act ENVIRONMENTAL PROTECTION determine whether this document
AGENCY applies to them. Potentially affected
Pursuant to the Congressional Review entities may include:
Act (5 U.S.C. 801 et seq.), EPA will 40 CFR Part 180 • Crop production (NAICS code 111).
submit a report containing this rule and • Animal production (NAICS code
[EPA–HQ–OPP–2016–0681; FRL–9972–69]
other required information to the U.S. 112).
Senate, the U.S. House of Zoxamide; Pesticide Tolerances • Food manufacturing (NAICS code
Representatives, and the Comptroller 311).
General of the United States prior to AGENCY: Environmental Protection • Pesticide manufacturing (NAICS
publication of the rule in the Federal Agency (EPA). code 32532).
Register. This action is not a ‘‘major ACTION: Final rule. B. How can I get electronic access to
rule’’ as defined by 5 U.S.C. 804(2). other related information?
SUMMARY: This regulation establishes
List of Subjects in 40 CFR Part 180 tolerances for residues of zoxamide in or You may access a frequently updated
on banana. Gowan Company, LLC electronic version of EPA’s tolerance
Environmental protection, requested these tolerances under the regulations at 40 CFR part 180 through
Administrative practice and procedure, Federal Food, Drug, and Cosmetic Act the Government Printing Office’s e-CFR
Agricultural commodities, Pesticides (FFDCA). site at http://www.ecfr.gov/cgi-bin/text-
and pests, Reporting and recordkeeping idx?&c=ecfr&tpl=/ecfrbrowse/Title40/
DATES: This regulation is effective
requirements. 40tab_02.tpl.
February 9, 2018. Objections and
Dated: January 24, 2018. requests for hearings must be received C. How can I file an objection or hearing
Michael Goodis, on or before April 10, 2018, and must request?
Director, Registration Division, Office of be filed in accordance with the Under FFDCA section 408(g), 21
Pesticide Programs. instructions provided in 40 CFR part U.S.C. 346a, any person may file an
178 (see also Unit I.C. of the objection to any aspect of this regulation
Therefore, 40 CFR chapter I is SUPPLEMENTARY INFORMATION).
amended as follows: and may also request a hearing on those
ADDRESSES: The docket for this action, objections. You must file your objection
PART 180—[AMENDED] identified by docket identification (ID) or request a hearing on this regulation
number EPA–HQ–OPP–2016–0681, is in accordance with the instructions
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure
■ 1. The authority citation for part 180
or at the Office of Pesticide Programs proper receipt by EPA, you must
continues to read as follows:
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ–
Authority: 21 U.S.C. 321(q), 346a and 371. in the Environmental Protection Agency OPP–2016–0681 in the subject line on
■ 2. In § 180.667, amend the table in Docket Center (EPA/DC), West William the first page of your submission. All
paragraph (a) by: Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing
Constitution Ave. NW, Washington, DC must be in writing, and must be
■ i. Adding alphabetically the 20460–0001. The Public Reading Room received by the Hearing Clerk on or
commodities ‘‘Cherry subgroup 12– is open from 8:30 a.m. to 4:30 p.m., before April 10, 2018. Addresses for
12A’’, ‘‘Hop, dried cones’’, and Monday through Friday, excluding legal mail and hand delivery of objections
‘‘Vegetable, fruiting, group 8–10’’, and holidays. The telephone number for the and hearing requests are provided in 40
■ ii. Revising the commodity Public Reading Room is (202) 566–1744, CFR 178.25(b).
‘‘Vegetable, cucurbit, group 9’’. and the telephone number for the OPP In addition to filing an objection or
Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk
The additions and revisions read as the visitor instructions and additional
follows: as described in 40 CFR part 178, please
information about the docket available submit a copy of the filing (excluding
§ 180.667 Cyflufenamid; tolerances for at http://www.epa.gov/dockets. any Confidential Business Information
residues. FOR FURTHER INFORMATION CONTACT: (CBI)) for inclusion in the public docket.
Michael L. Goodis, P.E., Director, Information not marked confidential
(a) * * * Registration Division (7505P), Office of pursuant to 40 CFR part 2 may be
Pesticide Programs, Environmental disclosed publicly by EPA without prior
Parts per
Commodity million Protection Agency, 1200 Pennsylvania notice. Submit the non-CBI copy of your
Ave. NW, Washington, DC 20460–0001; objection or hearing request, identified
main telephone number: (703) 305– by docket ID number EPA–HQ–OPP–
* * * * * 7090; email address: RDFRNotices@ 2016–0681, by one of the following
epa.gov. methods:
Cherry subgroup 12–12A ............. 0.60 • Federal eRulemaking Portal: http://
SUPPLEMENTARY INFORMATION:
www.regulations.gov. Follow the online
* * * * * I. General Information instructions for submitting comments.
Do not submit electronically any
A. Does this action apply to me?
Hop, dried cones .......................... 5.0 information you consider to be CBI or
Vegetable, cucurbit, group 9 ........ 0.10 You may be potentially affected by other information whose disclosure is
sradovich on DSK3GMQ082PROD with RULES
Vegetable, fruiting, group 8–10 .... 0.20 this action if you are an agricultural restricted by statute.
producer, food manufacturer, or • Mail: OPP Docket, Environmental
* * * * * pesticide manufacturer. The following Protection Agency Docket Center (EPA/
[FR Doc. 2018–02670 Filed 2–8–18; 8:45 am] list of North American Industrial DC), (28221T), 1200 Pennsylvania Ave.
BILLING CODE 6560–50–P Classification System (NAICS) codes is NW, Washington, DC 20460–0001.
not intended to be exhaustive, but rather • Hand Delivery: To make special
provides a guide to help readers arrangements for hand delivery or
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2905; email address: residuemethods@ field-trial residue data. The field-trial government and the States or tribal
epa.gov. data on unbagged, whole fruit banana governments, or on the distribution of
residues with a 0-day pre-harvest power and responsibilities among the
B. International Residue Limits
interval (PHI) were used from each field various levels of government or between
In making its tolerance decisions, EPA trial to calculate the tolerance. the Federal Government and Indian
seeks to harmonize U.S. tolerances with tribes. Thus, the Agency has determined
international standards whenever V. Conclusion
that Executive Order 13132, entitled
possible, consistent with U.S. food Therefore, a tolerance is established ‘‘Federalism’’ (64 FR 43255, August 10,
safety standards and agricultural for residues of zoxamide, (3, 5-dichloro- 1999) and Executive Order 13175,
practices. EPA considers the N-(3-chloro-1-ethyl-1-methyl-2- entitled ‘‘Consultation and Coordination
international maximum residue limits oxopropyl)-4-methylbenzamide), in or with Indian Tribal Governments’’ (65 FR
(MRLs) established by the Codex on banana at 0.20 ppm. 67249, November 9, 2000) do not apply
Alimentarius Commission (Codex), as to this action. In addition, this action
VI. Statutory and Executive Order
required by FFDCA section 408(b)(4). does not impose any enforceable duty or
Reviews
The Codex Alimentarius is a joint contain any unfunded mandate as
United Nations Food and Agriculture This action establishes a tolerance
described under Title II of the Unfunded
Organization/World Health under FFDCA section 408(d) in
Mandates Reform Act (UMRA) (2 U.S.C.
Organization food standards program, response to a petition submitted to the
1501 et seq.).
and it is recognized as an international Agency. The Office of Management and
food safety standards-setting Budget (OMB) has exempted these types This action does not involve any
organization in trade agreements to of actions from review under Executive technical standards that would require
which the United States is a party. EPA Order 12866, entitled ‘‘Regulatory Agency consideration of voluntary
may establish a tolerance that is Planning and Review’’ (58 FR 51735, consensus standards pursuant to section
different from a Codex MRL; however, October 4, 1993). Because this action 12(d) of the National Technology
FFDCA section 408(b)(4) requires that has been exempted from review under Transfer and Advancement Act
EPA explain the reasons for departing Executive Order 12866, this action is (NTTAA) (15 U.S.C. 272 note).
from the Codex level. not subject to Executive Order 13211, VII. Congressional Review Act
The Codex has not established a MRL entitled ‘‘Actions Concerning
for zoxamide. Regulations That Significantly Affect Pursuant to the Congressional Review
Energy Supply, Distribution, or Use’’ (66 Act (5 U.S.C. 801 et seq.), EPA will
C. Response to Comments FR 28355, May 22, 2001); Executive submit a report containing this rule and
One comment was received from an Order 13045, entitled ‘‘Protection of other required information to the U.S.
anonymous respondent. The comment Children from Environmental Health Senate, the U.S. House of
is general to all pesticides and is against Risks and Safety Risks’’ (62 FR 19885, Representatives, and the Comptroller
tolerances being approved for any April 23, 1997); or Executive Order General of the United States prior to
chemical on any commodity. Although 13771, entitled ‘‘Reducing Regulations publication of the rule in the Federal
the Agency recognizes that some and Controlling Regulatory Costs’’ (82 Register. This action is not a ‘‘major
individuals believe that no residue of FR 9339, February 3, 2017). This action rule’’ as defined by 5 U.S.C. 804(2).
pesticides should be allowed in or on does not contain any information
food, the existing legal framework collections subject to OMB approval List of Subjects in 40 CFR Part 180
provided by section 408 of the Federal under the Paperwork Reduction Act Environmental protection,
Food, Drug and Cosmetic Act (FFDCA) (PRA) (44 U.S.C. 3501 et seq.), nor does Administrative practice and procedure,
authorizes the establishment of it require any special considerations Agricultural commodities, Pesticides
pesticide tolerances or exemptions under Executive Order 12898, entitled and pests, Reporting and recordkeeping
where the Agency determines that ‘‘Federal Actions to Address requirements.
tolerance or exemption meets the safety Environmental Justice in Minority
standard imposed by the statute. EPA Populations and Low-Income Dated: January 23, 2018.
has sufficient data to support a safety Populations’’ (59 FR 7629, February 16, Michael Goodis,
determination for the tolerance for 1994). Director, Registration Division, Office of
residues of zoxamide in or on banana. Since tolerances and exemptions that Pesticide Programs.
The commenter provided no additional are established on the basis of a petition
under FFDCA section 408(d), such as Therefore, 40 CFR chapter I is
information supporting a determination
the tolerance in this final rule, do not amended as follows:
that the exemption is not safe.
require the issuance of a proposed rule, PART 180—[AMENDED]
D. Revisions to Petitioned-For the requirements of the Regulatory
Tolerances Flexibility Act (RFA) (5 U.S.C. 601 et
The Agency is establishing a tolerance ■ 1. The authority citation for part 180
seq.), do not apply.
for residues of zoxamide in or on This action directly regulates growers, continues to read as follows:
banana at 0.20 ppm, which is lower food processors, food handlers, and food Authority: 21 U.S.C. 321(q), 346a and 371.
than the 0.30 ppm tolerance requested. retailers, not States or tribes, nor does
This is because there is a difference this action alter the relationships or ■ 2. In § 180.567, add alphabetically the
between how the petitioner calculated distribution of power and entry ‘‘Banana’’ to the table in paragraph
sradovich on DSK3GMQ082PROD with RULES
the proposed tolerance and how the responsibilities established by Congress (a) and add footnote 1 to the table to
Agency calculates the tolerance. The in the preemption provisions of FFDCA read as follows:
0.20 ppm tolerance being set on banana section 408(n)(4). As such, the Agency § 180.567 Zoxamide; tolerances for
was calculated using the Organization has determined that this action will not residues.
for Economic Cooperation and have a substantial direct effect on States
Development (OECD) tolerance or tribal governments, on the (a) * * *
calculation procedures and available relationship between the national (1) * * *
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Parts per device for the deaf (TDD) may call the and comments into the SSA report and
Commodity million Federal Relay Service at 800–877–8339. the final listing rule. The SSA report
Website: https://www.fws.gov/ and other materials relating to this
Banana 1 ..................................... 0.20 southwest/es/TexasCoastal/. proposal can be found at http://
SUPPLEMENTARY INFORMATION: www.regulations.gov under Docket No.
* * * * *
FWS–R2–ES–2016–0077.
1 There
are no U.S. registrations allowing
Executive Summary
Previous Federal Actions
use of zoxamide on banana as of February 9, Why we need to publish a rule. Under
2018. the Endangered Species Act, a species is On August 10, 2016, we published a
* * * * * added to the Federal List of Endangered proposed rule (81 FR 52796) to list the
[FR Doc. 2018–02668 Filed 2–8–18; 8:45 am] and Threatened Wildlife if it is Texas hornshell as an endangered
BILLING CODE 6560–50–P endangered or threatened throughout all species under the Endangered Species
or a significant portion of its range. Act of 1973, as amended (Act; 16 U.S.C.
Listing a species as an endangered or 1531 et seq.). The publication of this
threatened species can only be proposed rule complied with a deadline
DEPARTMENT OF THE INTERIOR
completed by issuing a rule. The Lists established in a court-approved
Fish and Wildlife Service of Endangered and Threatened Wildlife settlement agreement (Endangered
and Plants are located in title 50 of the Species Act Section 4 Deadline
50 CFR Part 17 Code of Federal Regulations (CFR) in Litigation, No. 10–377 (EGS), MDL
part 17. Docket No. 2165 (D.D.C. May 10, 2011)).
[Docket No. FWS–R2–ES–2016–0077; What this rule does. This rule That proposal had a 60-day comment
4500030113] finalizes the listing of the Texas period, ending October 11, 2016. We
RIN 1018–BB34 hornshell (Popenaias popeii) as an reopened the comment period for 30
endangered species. The species will be days on May 30, 2017 (82 FR 24654), in
Endangered and Threatened Wildlife added to the List of Endangered and order to hold two public hearings on the
and Plants; Endangered Species Threatened Wildlife at 50 CFR 17.11(h). proposed rule. We then extended the
Status for Texas Hornshell The basis for our action. Under the final listing determination for 6 months
Endangered Species Act, we can due to substantial scientific
AGENCY: Fish and Wildlife Service, determine that a species is an disagreement about the species’ status
Interior. endangered or threatened species based in Mexico and reopened the comment
ACTION: Final rule. on any of the following factors: (A) The period for an additional 30 days (82 FR
present or threatened destruction, 37397). For a description of previous
SUMMARY: We, the U.S. Fish and modification, or curtailment of its Federal actions concerning the Texas
Wildlife Service (Service), determine habitat or range; (B) Overutilization for hornshell, please refer to the August 10,
endangered species status under the commercial, recreational, scientific, or 2016, proposed listing rule (81 FR
Endangered Species Act of 1973 (Act), educational purposes; (C) Disease or 52796).
as amended, for the Texas hornshell predation; (D) The inadequacy of
(Popenaias popeii), a freshwater mussel existing regulatory mechanisms; or (E) Background
species from New Mexico, Texas, and Other natural or manmade factors A thorough review of the taxonomy,
Mexico. The effect of this regulation affecting its continued existence. life history, and ecology of Texas
will be to add this species to the List of The Texas hornshell is an endangered hornshell (Popenaias popeii) is
Endangered and Threatened Wildlife. species based on impairment of water presented in the SSA report (Service
DATES: This rule becomes effective quality, loss of flowing water, and 2018, entire).
March 12, 2018. accumulation of fine sediment (Factor
A), predation (Factor C), and barriers to Species Description
ADDRESSES: This final rule is available
host fish movement and the effects of The Texas hornshell is a medium-
on the internet at http://
climate change (Factor E). sized (3 to 4 inches long) freshwater
www.regulations.gov in Docket No. Peer review and public comment. We mussel with a dark brown to green,
FWS–R2–ES–2016–0077 and in https:// prepared a species status assessment elongate, laterally compressed shell
www.fws.gov/southwest/es/ report (SSA report) for the Texas (Howells et al. 1996, p. 93; Carman
TexasCoastal/. Comments and materials hornshell. The SSA report documents 2007, p. 2). The Texas hornshell was
we received, as well as supporting the results of the comprehensive described by Lea (1857, p. 102) from the
documentation we used in preparing biological status review for the Texas Devils River in Texas and Rio Salado in
this rule, are available for public hornshell and provides an account of Mexico. Currently, the Texas hornshell
inspection at http:// the species’ overall viability through is classified in the unionid subfamily
www.regulations.gov. Comments, forecasting of the species’ condition in Ambleminae (Campbell et al. 2005, pp.
materials, and documentation that we the future (Service 2018, entire). We 140, 144) and is considered a valid
considered in this rulemaking will be sought comments on the SSA report taxon by the scientific community
available by appointment, during from independent specialists to ensure (Williams et al. 2017, p. 42).
normal business hours at the address that our analysis was based on Freshwater mussels, including the
shown in FOR FURTHER INFORMATION scientifically sound data, assumptions, Texas hornshell, have a complex life
CONTACT.
and analyses. We received feedback history. Males release sperm into the
sradovich on DSK3GMQ082PROD with RULES
FOR FURTHER INFORMATION CONTACT: from four scientists with expertise in water column, which are taken in by the
Charles Ardizzone, U.S. Fish and freshwater mussel biology, ecology, and female through the incurrent siphon
Wildlife Service, Texas Coastal genetics. During the comment period for (the tubular structure used to draw
Ecological Services Field Office, 17629 the proposed rule, we reached out to an water into the body of the mussel). The
El Camino Real #211, Houston, TX additional five peer reviewers, and we sperm fertilize the eggs, which are held
77058; or by telephone 281–286–8282. received responses from three. We during maturation in an area of the gills
Persons who use a telecommunications incorporated peer review suggestions called the marsupial chamber. The
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Document Created: 2018-02-09 00:12:10
Document Modified: 2018-02-09 00:12:10
| 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 February 9, 2018. Objections and requests for hearings must be received on or before April 10, 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 L. Goodis, P.E., Director, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, | |
| FR Citation | 83 FR 5717 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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