80 FR 10003 - Clothianidin; Pesticide Tolerances for Emergency Exemptions
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 37 (February 25, 2015)
Federal Register Volume 80, Issue 37 (February 25, 2015)
| Page Range | 10003-10007 | |
| FR Document | 2015-03928 |
[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)] [Rules and Regulations] [Pages 10003-10007] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-03928] ======================================================================= ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA-HQ-OPP-2014-0253; FRL-9919-59] Clothianidin; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This regulation establishes a time-limited tolerance for residues of clothianidin, (E)-N-[(2-chloro-5-thiazolyl)methyl]-N'- methyl-N''-nitroguanidine, in or on fruit, citrus, group 10-10. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on citrus. This regulation establishes a maximum permissible level for residues of clothianidin in or on citrus. The time-limited tolerance expires on December 31, 2017. DATES: This regulation is effective February 25, 2015. Objections and requests for hearings must be received on or before April 27, 2015, and must be filed in accordance with the instructions provided in 40 CFR part [[Page 10004]] 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-2014-0253, 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:[emsp14]Crop production (NAICS code 111). [emsp14]Animal production (NAICS code 112). [emsp14]Food manufacturing (NAICS code 311). [emsp14]Pesticide manufacturing (NAICS code 32532). B. How can I get electronic access to other related information? You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. C. How can I file an objection or hearing request? Under section 408(g) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 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- 2014-0253 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 27, 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-2014-0253, 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 EPA, on its own initiative, in accordance with FFDCA sections 408(e) and 408(l)(6) of, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing a time-limited tolerance for residues of clothianidin, (E)-N-[(2-chloro-5-thiazolyl)methyl]-N'-methyl-N''-nitroguanidine, in or on fruit, citrus, group 10-10 at 0.07 parts per million (ppm). This time-limited tolerance expires on December 31, 2017. Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement of a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under FIFRA section 18. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of FFDCA section 408 and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party. 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 . . . . '' Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that ``emergency conditions exist which require such exemption.'' EPA has established regulations governing such emergency exemptions in 40 CFR part 166. III. Emergency Exemption for Clothianidin in or on Immature Citrus Trees and FFDCA Tolerances The Florida Department of Agriculture and Consumer Services requested the EPA Administrator to issue a specific exemption for the use of clothianidin as a soil drench application on immature citrus trees to control the transmission of Huanglongbing (HLB) disease vectored by the Asian Citrus Psyllid (ACP). The applicant asserts that clothianidin is needed to control HLB disease due to the lack of effective available alternatives for season long control practices, and that significant economic losses will occur if this [[Page 10005]] urgent, non-routine disease is not controlled. Further, the Applicant asserts that an emergency condition exists in accordance with the criteria for approval of an emergency exemption, and issued a crisis exemption under FIFRA section 18 to allow the use of clothianidin on immature citrus trees for control of the transmission of HLB disease vectored by the ACP in Florida. After having reviewed the submission, EPA concurred that an emergency condition exists for Florida citrus growers and authorized a specific emergency exemption under FIFRA section 18 for control of clothianidin on immature citrus trees to control the transmission of HLB disease vectored by the ACP. As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of clothianidin in or on citrus. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2), and EPA decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non- routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in FFDCA section 408(l)(6). Although this time-limited tolerance expires on December 31, 2017, under FFDCA section 408(l)(5), residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on fruit, citrus, group 10-10 after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by the time-limited tolerance at the time of that application. EPA will take action to revoke this time-limited tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe. Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether clothianidin meets FIFRA's registration requirements for use on fruit, citrus, group 10-10 or whether a permanent tolerance for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of clothianidin by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than Florida to use this pesticide on the applicable crop under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for clothianidin contact the Agency's Registration Division at the address provided under FOR FURTHER INFORMATION CONTACT. IV. 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. . . .'' As part of its evaluation of the emergency exemption application, EPA assessed the potential risks presented by residues of clothianidin in or on citrus. In doing so, EPA considered the safety standard in FFDCA section 408(b)(2) and decided that the necessary tolerance under FFDCA section 408(l)(6) would be consistent with the safety standard and with FIFRA section 18. Consistent with 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 emergency action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure expected as a result of this emergency exemption and the time-limited tolerance for residues of clothianidin in or on fruit, citrus, group 10-10 at 0.07 ppm. EPA recently evaluated the currently approved uses of clothianidin when establishing tolerances for residues of clothianidin in three non- citrus commodity groups in the March 29, 2013 Federal Register (78 FR 19130) (FRL-9378-6). A summary of the human risk assessment toxicological endpoints is discussed in Units 111.A. and B. of the March 29, 2013 Final Rule. EPA has also recently evaluated the dietary exposure that would result from a similar use of clothianidin on citrus that would result in clothianidin residues of 0.60 ppm. This is significantly higher than the 0.07 ppm time-limited tolerance level established in today's final rule. In order to expedite this time-limited tolerance rule, EPA has relied on its previous dietary risk assessment assuming clothianidin residues of 0.60 ppm on citrus. The higher application rates and concentrations assure that exposure and risk resulting from the emergency use are not underestimated. In addition, the estimated drinking water concentrations based on the clothianidin use on citrus resulted in higher acute drinking water estimates than those previously assessed. The chronic analysis drinking water estimate remains the same as it was in the previous dietary assessment. Even with these conservative assumptions, the revised acute dietary risk estimates from exposure to clothianidin through food and water are below the Agency's level of concern for all population subgroups. In its aggregate assessment of exposures and risk associated with clothianidin, including use on citrus which was assessed at a significantly higher use rate, EPA concluded that the acute dietary exposure from food and water to clothianidin would occupy 28% of the acute population adjusted dose (aPAD) for children 1-2 years old, the population subgroup receiving the greatest exposure; and that chronic exposure to clothianidin from food and water would utilize 28% of the chronic population adjusted dose (cPAD) for children 1-2 years old, the population subgroup receiving the greatest exposure. These population adjusted doses represent the levels below which exposure is not of health concern. Because these levels of dietary exposures for the most exposed subpopulations would be well below the aPAD and cPAD, the expected lower levels of dietary exposures are not of concern. There are no new residential uses of clothianidin at this time. However, existing uses of clothianidin on turf, ornamental plants, and/ or indoor surfaces for bed bug control may result in human exposure in a residential setting. Such exposures may occur during application of products containing clothianidin (handler exposure) as well as following application (post-application exposure) and are expected to be of short-term (1-30 days) duration. [[Page 10006]] For clothianidin, residential handler and post-application risk estimates are considered to be of potential concern when the dermal margin of exposure (MOE) is less than 100, the inhalation MOE is less than 1,000, and/or the aggregate risk index (ARI), reflecting combined dermal and inhalation exposure, is less than one. The residential handler and post-application risk estimates are not of concern (ARIs range from 1.9 to 990). The aggregate ARIs, which combine residential and dietary exposure, ranged from 1.2 to 6.5, which are not of concern (i.e. when the ARI is greater 1). Therefore, EPA concluded there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to clothianidin residues as a result of existing uses and the proposed section 18 use pattern. Refer to the March 29, 2013 final rule, available at http://regulations.gov, for a summary of the aggregate risk assessment and determination of safety. Detailed discussion of the aggregate risk assessments and the determinations of safety relied upon in this action may be found in the Agency reviews and human health risk assessments provided as supporting documents in the docket for this action under docket ID number EPA-HQ-OPP-2014-0253. V. Other Considerations A. Analytical Enforcement Methodology An adequate enforcement methodology, based on solvent extraction and liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/ MS) separation, identification, and quantification, is available for plant (Morse Method#Meth-164-modified, RM-39C-1, or Bayer Method 00552) matrices to enforce the tolerance expression. The limit of quantitation (LOQ) for clothianidin in plant commodities is 0.01 ppm. Clothianidin and its major metabolites are not adequately recovered using any of the United States Food and Drug Administration (FDA) multi-residue methods. The methods may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: [email protected]. 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 established MRLs for clothianidin in or on citrus fruits at 0.07 ppm, the same level the U.S. is establishing for the time-limited-tolerance. VI. Conclusion Therefore, a time-limited tolerance is established for residues of clothianidin, in or on fruit, citrus, group 10-10 at 0.07 ppm. This tolerance expires on December 31, 2017. VII. Statutory and Executive Order Reviews This final rule establishes tolerances under FFDCA sections 408(e) and 408(l)(6). 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 final rule has been exempted from review under Executive Order 12866, this final rule 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 final rule 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 in accordance with FFDCA sections 408(e) and 408(l)(6), such as the tolerances 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 final rule 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 final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note). VIII. 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: February 13, 2015. Susan Lewis, Director, Registration Division, Office of Pesticide Programs. Therefore, 40 CFR chapter I is amended as follows: [[Page 10007]] 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. 180.586, revise paragraph (b) to read as follows: Sec. 180.586 Clothianidin; tolerances for residues. * * * * * (b) Section 18 emergency exemptions. A time-limited tolerance specified in the following table is established for residues of clothianidin, (E)-N-[(2-chloro-5-thiazolyl)methyl]-N'-methyl-N''- nitroguanidine, in or on the specified agricultural commodity, resulting from use of the pesticide pursuant to FIFRA section 18 emergency exemptions. This tolerance expires on the date specified in the table. ------------------------------------------------------------------------ Parts per Expiration Commodity million date ------------------------------------------------------------------------ Fruit, citrus, group 10-10.................... 0.07 12/31/17 ------------------------------------------------------------------------ * * * * * [FR Doc. 2015-03928 Filed 2-24-15; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Rules and Regulations 10003
process, depriving ALS veterans and recipients thereof; or (4) Raise novel Dated: February 20, 2015.
members of the Armed Forces serving legal or policy issues arising out of legal William F. Russo,
on active duty with ALS of quick and mandates, the President’s priorities, or Acting Director, Office of Regulation Policy
efficient access to automobile or other the principles set forth in this Executive & Management, Office of the General Counsel,
conveyance and adaptive equipment Order.’’ U.S. Department of Veterans Affairs.
benefits. For the reasons set out in the
For the foregoing reasons, the The economic, interagency,
budgetary, legal, and policy preamble, VA amends 38 CFR part 3 as
Secretary is issuing this rule as an follows:
interim final rule with immediate effect. implications of this regulatory action
have been examined, and it has been PART 3—ADJUDICATION
Paperwork Reduction Act determined not to be a significant
This interim final rule contains no regulatory action under Executive Order Subpart A—Pension, Compensation,
provisions constituting a collection of 12866. VA’s impact analysis can be and Dependency and Indemnity
information under the Paperwork found as a supporting document at Compensation
Reduction Act of 1995 (44 U.S.C. 3501– http://www.regulations.gov, usually
3521). within 48 hours after the rulemaking ■ 1. The authority citation for part 3,
document is published. Additionally, a subpart A continues to read as follows:
Regulatory Flexibility Act
copy of the rulemaking and its impact Authority: 38 U.S.C. 501(a), unless
The Secretary hereby certifies that otherwise noted.
this interim final rule will not have a analysis are available on VA’s Web site
significant economic impact on a at http://www.va.gov/orpm/, by ■ 2. Amend § 3.808 by redesignating
substantial number of small entities as following the link for VA Regulations paragraph (b)(5) as paragraph (b)(6) and
they are defined in the Regulatory Published From FY 2004 Through adding a new paragraph (b)(5) to read as
Flexibility Act, 5 U.S.C. 601–612. This FYTD. follows:
interim final rule will not affect any Unfunded Mandates § 3.808 Automobiles or other conveyances
small entities. Only VA beneficiaries and adaptive equipment; certification.
will be directly affected. Therefore, The Unfunded Mandates Reform Act
* * * * *
pursuant to 5 U.S.C. 605(b), this interim of 1995 requires, at 2 U.S.C. 1532, that (b) * * *
final rule is exempt from the final agencies prepare an assessment of (5) Amyotrophic lateral sclerosis.
regulatory flexibility analysis anticipated costs and benefits before
requirements of section 604. * * * * *
issuing any rule that may result in the [FR Doc. 2015–03889 Filed 2–24–15; 8:45 am]
Executive Orders 12866 and 13563 expenditure by State, local, and tribal
BILLING CODE P
governments, in the aggregate, or by the
Executive Orders 12866 and 13563
private sector, of $100 million or more
direct agencies to assess the costs and
(adjusted annually for inflation) in any
benefits of available regulatory ENVIRONMENTAL PROTECTION
alternatives and, when regulation is 1 year. This interim final rule will have
AGENCY
necessary, to select regulatory no such effect on State, local, and tribal
approaches that maximize net benefits governments, or on the private sector. 40 CFR Part 180
(including potential economic, Catalog of Federal Domestic Assistance [EPA–HQ–OPP–2014–0253; FRL–9919–59]
environmental, public health and safety
effects, and other advantages; The Catalog of Federal Domestic Clothianidin; Pesticide Tolerances for
distributive impacts; and equity). Assistance numbers and titles for the Emergency Exemptions
Executive Order 13563 (Improving programs affected by this document are
Regulation and Regulatory Review) 64.100, Automobiles and Adaptive AGENCY: Environmental Protection
emphasizes the importance of Equipment for Certain Disabled Agency (EPA).
quantifying both costs and benefits, Veterans and Members of the Armed ACTION: Final rule.
reducing costs, harmonizing rules, and Forces and 64.109, Veterans
promoting flexibility. Executive Order SUMMARY: This regulation establishes a
Compensation for Service-Connected
12866 (Regulatory Planning and time-limited tolerance for residues of
Disability.
Review) defines a ‘‘significant clothianidin, (E)-N-[(2-chloro-5-
regulatory action,’’ which requires Signing Authority thiazolyl)methyl]-N’-methyl-N’’-
review by the Office of Management and nitroguanidine, in or on fruit, citrus,
Budget (OMB), unless OMB waives such The Secretary of Veterans Affairs, or group 10–10. This action is in response
review, as ‘‘any regulatory action that is designee, approved this document and to EPA’s granting of an emergency
likely to result in a rule that may: (1) authorized the undersigned to sign and exemption under the Federal
Have an annual effect on the economy submit the document to the Office of the Insecticide, Fungicide, and Rodenticide
of $100 million or more or adversely Federal Register for publication Act (FIFRA) authorizing use of the
affect in a material way the economy, a electronically as an official document of pesticide on citrus. This regulation
sector of the economy, productivity, the Department of Veterans Affairs. Jose establishes a maximum permissible
competition, jobs, the environment, D. Riojas, Chief of Staff, approved this level for residues of clothianidin in or
public health or safety, or State, local, document on February 12, 2015, for on citrus. The time-limited tolerance
wreier-aviles on DSK5TPTVN1PROD with RULES
or tribal governments or communities; publication. expires on December 31, 2017.
(2) Create a serious inconsistency or DATES: This regulation is effective
List of Subjects in 38 CFR Part 3
otherwise interfere with an action taken February 25, 2015. Objections and
or planned by another agency; (3) Administrative practice and requests for hearings must be received
Materially alter the budgetary impact of procedure, Claims, Disability benefits, on or before April 27, 2015, and must
entitlements, grants, user fees, or loan Health care, Pensions, Veterans. be filed in accordance with the
programs or the rights and obligations of instructions provided in 40 CFR part
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![10004 Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Rules and Regulations
178 (see also Unit I.C. of the objection to any aspect of this regulation result from the use of a pesticide under
SUPPLEMENTARY INFORMATION). and may also request a hearing on those an emergency exemption granted by
ADDRESSES: The docket for this action, objections. You must file your objection EPA under FIFRA section 18. Such
identified by docket identification (ID) or request a hearing on this regulation tolerances can be established without
number EPA–HQ–OPP–2014–0253, is in accordance with the instructions providing notice or period for public
available at http://www.regulations.gov provided in 40 CFR part 178. To ensure comment. EPA does not intend for its
or at the Office of Pesticide Programs proper receipt by EPA, you must actions on FIFRA section 18 related
Regulatory Public Docket (OPP Docket) identify docket ID number EPA–HQ– time-limited tolerances to set binding
in the Environmental Protection Agency OPP–2014–0253 in the subject line on precedents for the application of FFDCA
Docket Center (EPA/DC), West William the first page of your submission. All section 408 and the safety standard to
Jefferson Clinton Bldg., Rm. 3334, 1301 objections and requests for a hearing other tolerances and exemptions.
Constitution Ave. NW., Washington, DC must be in writing, and must be Section 408(e) of FFDCA allows EPA to
20460–0001. The Public Reading Room received by the Hearing Clerk on or establish a tolerance or an exemption
is open from 8:30 a.m. to 4:30 p.m., before April 27, 2015. Addresses for from the requirement of a tolerance on
Monday through Friday, excluding legal mail and hand delivery of objections its own initiative, i.e., without having
holidays. The telephone number for the and hearing requests are provided in 40 received any petition from an outside
Public Reading Room is (202) 566–1744, CFR 178.25(b). party.
and the telephone number for the OPP In addition to filing an objection or Section 408(b)(2)(A)(i) of FFDCA
Docket is (703) 305–5805. Please review hearing request with the Hearing Clerk allows EPA to establish a tolerance (the
the visitor instructions and additional as described in 40 CFR part 178, please legal limit for a pesticide chemical
information about the docket available submit a copy of the filing (excluding residue in or on a food) only if EPA
at http://www.epa.gov/dockets. any Confidential Business Information determines that the tolerance is ‘‘safe.’’
(CBI)) for inclusion in the public docket. Section 408(b)(2)(A)(ii) of FFDCA
FOR FURTHER INFORMATION CONTACT:
Information not marked confidential defines ‘‘safe’’ to mean that ‘‘there is a
Susan Lewis, Registration Division
pursuant to 40 CFR part 2 may be reasonable certainty that no harm will
(7505P), Office of Pesticide Programs,
disclosed publicly by EPA without prior result from aggregate exposure to the
Environmental Protection Agency, 1200
notice. Submit the non-CBI copy of your pesticide chemical residue, including
Pennsylvania Ave. NW., Washington,
objection or hearing request, identified all anticipated dietary exposures and all
DC 20460–0001; main telephone
by docket ID number EPA–HQ–OPP– other exposures for which there is
number: (703) 305–7090; email address:
2014–0253, by one of the following reliable information.’’ This includes
RDFRNotices@epa.gov.
methods: exposure through drinking water and in
SUPPLEMENTARY INFORMATION: • Federal eRulemaking Portal: http:// residential settings, but does not include
I. General Information www.regulations.gov. Follow the online occupational exposure. Section 408(b)
instructions for submitting comments. (2) (C) of FFDCA requires EPA to give
A. Does this action apply to me? Do not submit electronically any special consideration to exposure of
You may be potentially affected by information you consider to be CBI or infants and children to the pesticide
this action if you are an agricultural other information whose disclosure is chemical residue in establishing a
producer, food manufacturer, or restricted by statute. tolerance and to ‘‘ensure that there is a
pesticide manufacturer. The following • Mail: OPP Docket, Environmental
reasonable certainty that no harm will
list of North American Industrial Protection Agency Docket Center (EPA/
result to infants and children from
Classification System (NAICS) codes is DC), (28221T), 1200 Pennsylvania Ave.
aggregate exposure to the pesticide
not intended to be exhaustive, but rather NW., Washington, DC 20460–0001.
chemical residue . . . . ’’
provides a guide to help readers • Hand Delivery: To make special
arrangements for hand delivery or Section 18 of FIFRA authorizes EPA
determine whether this document to exempt any Federal or State agency
applies to them. Potentially affected delivery of boxed information, please
follow the instructions at http:// from any provision of FIFRA, if EPA
entities may include: determines that ‘‘emergency conditions
• Crop production (NAICS code 111). www.epa.gov/dockets/contacts.html.
exist which require such exemption.’’
• Animal production (NAICS code Additional instructions on
commenting or visiting the docket, EPA has established regulations
112).
• Food manufacturing (NAICS code along with more information about governing such emergency exemptions
311). dockets generally, is available at in 40 CFR part 166.
• Pesticide manufacturing (NAICS http://www.epa.gov/dockets. III. Emergency Exemption for
code 32532). II. Background and Statutory Findings Clothianidin in or on Immature Citrus
B. How can I get electronic access to Trees and FFDCA Tolerances
EPA, on its own initiative, in
other related information? accordance with FFDCA sections 408(e) The Florida Department of
You may access a frequently updated and 408(l)(6) of, 21 U.S.C. 346a(e) and Agriculture and Consumer Services
electronic version of 40 CFR part 180 346a(1)(6), is establishing a time-limited requested the EPA Administrator to
through the Government Printing tolerance for residues of clothianidin, issue a specific exemption for the use of
Office’s e-CFR site at http:// (E)-N-[(2-chloro-5-thiazolyl)methyl]-N’- clothianidin as a soil drench application
www.ecfr.gov/cgi-bin/text- methyl-N’’-nitroguanidine, in or on on immature citrus trees to control the
transmission of Huanglongbing (HLB)
wreier-aviles on DSK5TPTVN1PROD with RULES
idx?&c=ecfr&tpl=/ecfrbrowse/Title40/ fruit, citrus, group 10–10 at 0.07 parts
40tab_02.tpl. per million (ppm). This time-limited disease vectored by the Asian Citrus
tolerance expires on December 31, 2017. Psyllid (ACP). The applicant asserts that
C. How can I file an objection or hearing Section 408(l)(6) of FFDCA requires clothianidin is needed to control HLB
request? EPA to establish a time-limited disease due to the lack of effective
Under section 408(g) of the Federal tolerance or exemption from the available alternatives for season long
Food, Drug, and Cosmetic Act (FFDCA), requirement of a tolerance for pesticide control practices, and that significant
21 U.S.C. 346a, any person may file an chemical residues in food that will economic losses will occur if this
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![Federal Register / Vol. 80, No. 37 / Wednesday, February 25, 2015 / Rules and Regulations 10007
PART 180—[AMENDED] DEPARTMENT OF COMMERCE catch limit (ACL) value for Atlantic
migratory group Spanish mackerel in
■ 1. The authority citation for part 180 National Oceanic and Atmospheric § 622.388(d)(1)(iii). The commercial
continues to read as follows: Administration ACL for Atlantic migratory group
Spanish mackerel is equal to the
Authority: 21 U.S.C. 321(q), 346a and 371. 50 CFR Part 622 commercial quota. The commercial
■ 2. In § 180.586, revise paragraph (b) to [Docket No. 131211999–5045–02] quota value was published correctly in
read as follows: § 622.384(c)(2), however, the
RIN 0648–BD86
commercial ACL value was published
§ 180.586 Clothianidin; tolerances for Fisheries of the Caribbean, Gulf of incorrectly in § 622.388(d)(1)(iii). This
residues. Mexico, and South Atlantic; Coastal document corrects the commercial ACL
* * * * * Migratory Pelagic Resources in the value for Atlantic migratory group
(b) Section 18 emergency exemptions. Gulf of Mexico and Atlantic Region; Spanish mackerel.
A time-limited tolerance specified in the Amendment 20B; Correction
Correction
following table is established for AGENCY: National Marine Fisheries
residues of clothianidin, (E)-N-[(2- Service (NMFS), National Oceanic and 1. On page 4223, in the first column,
chloro-5-thiazolyl)methyl]-N’-methyl- Atmospheric Administration (NOAA), § 622.388(d)(1)(iii) is correctly revised to
N’’-nitroguanidine, in or on the Commerce. read as follows:
specified agricultural commodity, ACTION: Final rule; correction. § 622.388 Annual catch limits (ACLs),
resulting from use of the pesticide annual catch targets (ACTs), and
pursuant to FIFRA section 18 SUMMARY: This document contains a
accountability measures (AMs).
correction to the final rule to implement
emergency exemptions. This tolerance * * * * *
Amendment 20B to the Fishery
expires on the date specified in the
Management Plan for the Coastal (d) * * *
table. Migratory Pelagic Resources in the
exclusive economic zone of the Gulf of (1) * * *
Parts per Expiration (iii) The commercial ACL for the
Commodity million date Mexico and Atlantic Region
(Amendment 20B) that was published in Atlantic migratory group Spanish
Fruit, citrus, group the Federal Register January 27, 2015. mackerel is 3.33 million lb (1.51 million
10–10 ................ 0.07 12/31/17 DATES: This correction is effective kg).
March 1, 2015. * * * * *
* * * * * FOR FURTHER INFORMATION CONTACT:
Dated: February 19, 2015.
[FR Doc. 2015–03928 Filed 2–24–15; 8:45 am] Anik Clemens, 727–551–5611; email:
Anik.Clemens@noaa.gov. Samuel D. Rauch III,
BILLING CODE 6560–50–P
SUPPLEMENTARY INFORMATION: Deputy Assistant Administrator for
Regulatory Programs, National Marine
Need for Correction Fisheries Service.
On January 27, 2015, (80 FR 4216), [FR Doc. 2015–03905 Filed 2–24–15; 8:45 am]
NMFS published an incorrect annual BILLING CODE 3510–22–P
wreier-aviles on DSK5TPTVN1PROD with RULES
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Document Created: 2015-12-18 13:09:20
Document Modified: 2015-12-18 13:09:20
| 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 25, 2015. Objections and requests for hearings must be received on or before April 27, 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 10003 | |
| CFR Associated | Environmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements |
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