Fenamiphos; Data Call-in Order for Pesticide Tolerances, 13499-13502 [2012-5383]

Download as PDF Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Rules and Regulations materials specifications, test methods, sampling procedures, and business practices) that are developed or adopted by voluntary consensus standards bodies. NTTAA directs EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. This rulemaking does not involve technical standards. Therefore, EPA did not consider the use of any voluntary consensus standards. srobinson on DSK4SPTVN1PROD with RULES J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations Executive Order (E.O.) 12898 (59 FR 7629 (Feb. 16, 1994)) establishes Federal executive policy on environmental justice. Its main provision directs agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. This action is not subject to E.O. 12898 because this action merely extends the effective date for already promulgated requirements. K. Congressional Review Act The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. Section 808 allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice and public procedure is impracticable, unnecessary or contrary to the public interest. This determination must be supported by a brief statement. 5 U.S.C. 808(2). As stated previously, EPA has made such a good cause finding, including the reasons therefore, and established an effective date of March 6, 2012. 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). VerDate Mar<15>2010 16:19 Mar 06, 2012 Jkt 226001 List of Subjects in 40 CFR Part 131 Environmental protection, Water quality standards, Nitrogen/phosphorus pollution, Nutrients, Florida. Dated: February 16, 2012. Lisa P. Jackson, Administrator. [FR Doc. 2012–5604 Filed 3–6–12; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [EPA–HQ–OPP–2011–0702; FRL–9339–7] Fenamiphos; Data Call-in Order for Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final order. AGENCY: This order requires the submission of various data to support the continuation of the tolerances for the pesticide fenamiphos. Pesticide tolerances are established under the Federal Food, Drug, and Cosmetic Act (FFDCA). Following publication of this order, persons who are interested in the continuation of the fenamiphos tolerances must notify the Agency by completing and submitting the required section 408(f) Order Response Form (available in the docket) within 90 days. If the Agency does not receive within 90 days after publication of the final order a section 408(f) Response Form identifying a person who agrees to submit the required data, EPA will revoke the fenamiphos tolerances. DATES: This final order is effective March 7, 2012. A section 408(f) Order Response Form must be received on or before June 5, 2012. ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2011–0702. All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), SUMMARY: PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 13499 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. Submit your section 408(f) Order Response Form, identified by docket identification (ID) number EPA–HQ– OPP–2011–0702, by one of the following methods: • Federal eRulemaking Portal: Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility’s normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305–5805. • Instructions: Direct your section 408(f) Order Response Form to docket ID number EPA–HQ–OPP–2011–0702. EPA’s policy is that all information and comments received will be included in the docket without change and may be made available on-line at https:// www.regulations.gov, including any personal information provided, unless the information or comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through regulations.gov or email. The regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send information or comments via an email directly to EPA without going through regulations.gov, your email address will be automatically captured and included as part of the information or comment that is placed in the docket and made available on the Internet. If you submit information or a comment electronically, EPA recommends that you include your name and other contact information in the body of your information or comment and with any disk or CD–ROM you submit. If EPA cannot read your information or comment due to technical difficulties and cannot contact E:\FR\FM\07MRR1.SGM 07MRR1 13500 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Rules and Regulations you for clarification, EPA may not be able to consider your submission. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. • Docket: All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Eric Miederhoff, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 347–8028; email address: miederhoff.eric@epa.gov. SUPPLEMENTARY INFORMATION: I. General Information srobinson on DSK4SPTVN1PROD with RULES 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. Potentially affected entities may include, but are not limited to: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult VerDate Mar<15>2010 16:19 Mar 06, 2012 Jkt 226001 the person listed under FOR FURTHER INFORMATION CONTACT. 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 cite at https:// ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 40tab_02.tpl. To access the harmonized test guidelines referenced in this document electronically, please go to https://www.epa.gov/ocspp and select ‘‘Test Methods and Guidelines,’’ which is listed under ‘‘Documents related to our mission.’’ II. Background A. What action is the agency taking? In this document EPA is issuing an order requiring the submission of various data to support the continuation of the fenamiphos tolerances at 40 CFR 180.349 under section 408 of the FFDCA, 21 U.S.C. 346a. Fenamiphos is not currently registered under FIFRA, 7 U.S.C. 136 et seq. The FIFRA registration for fenamiphos was canceled in 2007. However, four FFDCA tolerances remain for residues of fenamiphos on the following commodities: Bananas, grapes, pineapples, and raisins (40 CFR 180.349). Since there are currently no domestic registrations for fenamiphos, these tolerances are referred to as ‘‘import tolerances.’’ It is these tolerances that are addressed by the data call-in order. B. What is the agency’s authority for taking this action? Under section 408(f) of the FFDCA, EPA is authorized to require, by order, submission of data ‘‘reasonably required to support the continuation of a tolerance’’ when such data cannot be obtained under the Data Call-In authority of FIFRA section 3(c)(2)(B), or section 4 of the Toxic Substances Control Act (TSCA), 15 U.S.C. 2603. A FFDCA section 408 data call-in order may only be issued following publication of notice of the order and a 60-day public comment provision. A section 408(f) Data Call-In order must contain the following elements: 1. A requirement that one or more persons submit to EPA a notice identifying the person(s) who commit to submit the data required in the order; 2. A description of the required data and the required reports connected to such data; 3. An explanation of why the required data could not be obtained under PO 00000 Frm 00018 Fmt 4700 Sfmt 4700 section 3(c)(2)(B) of FIFRA or section 4 of TSCA; and 4. The required submission date for the notice identifying one or more interested persons who commit to submit the required data and the required submission dates for all the data and reports required in the order. (21 U.S.C. 346a(f)(1)(C)). EPA may by order modify or revoke the affected tolerances if any one of the following submissions is not made in a timely manner: i. A notice identifying the one or more interested persons who commit to submit the data; ii. The data itself; or iii. The reports required under a section 408(f) order are not submitted by the date specified in the order. (21 U.S.C. 346a(f)(2)). C. What preliminary steps were taken by EPA prior to issuing this final order? On August 31, 2011, EPA issued a proposed data call-in order for the pesticide fenamiphos in connection with tolerances for that pesticide under section 408 of the FFDCA, 21 U.S.C. 346a. (75 FR 44181). The proposed data call-in order included the following studies: 1. Comparative Cholinesterase Assay (Non-Guideline). 2. Immunotoxicity Study (870.7800). 3. Crop Field Trials (860.1500)— (grapes; foliar use in Mexico). III. Summary of Public Comments Received and Agency Response to Comments EPA received one comment in response to the August 31, 2011, Federal Register notice announcing the Agency’s proposed data call-in order for fenamiphos (76 FR 54185; FRL–8886–2). However, this comment merely argued that there are too many toxic chemicals approved for use in the United States and did not, in any manner, address the Agency’s intention to issue a data callin order for fenamiphos. Therefore, no response to this comment is needed. In addition, the Agency has not received any of the data identified in the proposed order as needed to support the fenamiphos tolerances. IV. Final Data Call-in Order Because no comments were submitted on the proposal and the data deficiencies identified in the proposed order remain, EPA is issuing this final data call-in order under FFDCA section 408(f)(1)(C) for fenamiphos in the same form as the proposed order and for the reasons set forth in that proposed order. Specifically, this order: 1. Requires Notice of Intent to Submit Data. A notice identifying the person or E:\FR\FM\07MRR1.SGM 07MRR1 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Rules and Regulations persons who commit to submit the data and reports in accordance with Unit V.2. must be submitted to EPA if any person wishes to support the fenamiphos tolerances. The notice must be submitted on a section 408(f) Order Response Form which is available in the electronic docket, https:// www.regulations.gov, under docket ID number EPA–HQ–OPP–2011–0702. 2. Establishes a Deadline for Submission of Notice Identifying Data Submitters. The notice described in Unit V.1. identifying data submitters must be submitted to and received by EPA on or before June 5, 2012. Instructions on methods for submitting this notice (referred to in this order as a ‘‘section 408(f) Order Response Form’’) are set out under ADDRESSES. 3. Describes Data and Reports Required to Support Continuation of the Fenamiphos Tolerances, Requires Submission of Those Data and Reports, and Establishes Deadlines for Submission. The table in this Unit describes the data and reports required to be submitted on fenamiphos under this order and the deadlines for the submission of each study and report. The required submission date is calculated from June 5, 2012. Thus, for example, if EPA generally allows 12 months to complete a study, the required submission date for such a study under this order would be 15 months from the date of publication of the order in the Federal Register. OCSPP Harmonized guideline No. Study title Timeframe for protocol report submission Non-Guideline ................................ 870.7800 ........................................ 860.1500 ........................................ Comparative Cholinesterase Assay ........................... Immunotoxicity Study ................................................. Crop Field Trials (grapes; foliar use in Mexico) ......... 12/7/2012 ....................................... 12/7/2012 ....................................... Not Required .................................. EPA provided a description of why the required data could not be obtained under section 3(c)(2)(B) of FIFRA or section 4 of TSCA in the proposed order and relies on that description in this final order. V. Failure To Submit Notice of Intent To Submit Data or Data and Reports If, by June 5, 2012 the Agency does not receive a section 408(f) Order Response Form identifying a person who agrees to submit the required data, EPA will revoke the fenamiphos tolerances at 40 CFR 180.349. Such revocation is subject to the objection and hearing procedure in FFDCA section 408(g)(2) but the only material issue in such a procedure is whether a submission required by the order was made in a timely fashion. Additional events that may be the basis for modification or revocation of fenamiphos tolerances include, but are not limited to the following: 1. No person submits on the required schedule an acceptable protocol report when such report is required to be submitted to the Agency for review. 2. No person submits on the required schedule acceptable data as required by the final order. srobinson on DSK4SPTVN1PROD with RULES VI. Statutory and Executive Order Reviews This action, which requires the submission of data in support of tolerances in accordance with FFDCA section 408, is in the form of an order and not a rule. (21 U.S.C. 346a(f)(1)(C)). Under the Administrative Procedures Act (APA), orders are expressly excluded from the definition of a rule. (5 U.S.C. 551(4)). Accordingly, the regulatory assessment requirements imposed on a rulemaking do not apply VerDate Mar<15>2010 16:19 Mar 06, 2012 Jkt 226001 to this action, as explained further in the following discussion. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review Because this order is not a ‘‘regulatory action’’ as that term is defined in Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not subject to review by the Office of Management and Budget (OMB) under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). B. Paperwork Reduction Act This action does not impose additional burdens that require approval by OMB under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). The information collection activities associated with the order requesting data from any party interested in supporting certain tolerances are already approved by OMB under OMB Control No. 2070–0174, and are identified by EPA ICR No. 2288.01. Burden is defined at 5 CFR 1320.3(b). Under the PRA, an Agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA’s regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument, or form, if applicable. Frm 00019 Fmt 4700 Sfmt 4700 Timeframe for data submission 6/7/2013 6/7/2013 6/9/2014 the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. D. Unfunded Mandates Reform Act; Executive Order 13132: Federalism; and Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This order requests data from any party interested in supporting certain tolerances and does not impose obligations on any person or entity including States or tribes; nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. 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 (64 FR 43255, August 10, 1999) and Executive Order 13175 (65 FR 67249, November 9, 2000) do not apply to this order. In addition, this order 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. 1531– 1538). C. Regulatory Flexibility Act Since this order is not a rule under the APA (5 U.S.C. 551(4)), and does not require the issuance of a proposed rule, PO 00000 13501 E:\FR\FM\07MRR1.SGM 07MRR1 13502 Federal Register / Vol. 77, No. 45 / Wednesday, March 7, 2012 / Rules and Regulations E. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks; Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use; and Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations As indicated previously, this action is not a ‘‘regulatory action’’ as defined by Executive Order 12866. As a result, this action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) and Executive Order 13211 (66 FR 28355, May 22, 2001). In addition, this order also does not require any special considerations under Executive Order 12898 (59 FR 7629, February 16, 1994). Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). DATES: This regulation is effective March 7, 2012. Objections and requests for hearings must be received on or before May 7, 2012, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION). [FR Doc. 2012–5383 Filed 3–6–12; 8:45 am] EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2010–0659. All documents in the docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at https://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S– 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305– 5805. FOR FURTHER INFORMATION CONTACT: Heather Garvie, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–0034; email address: garvie.heather@epa.gov. BILLING CODE 6560–50–P SUPPLEMENTARY INFORMATION: F. National Technology Transfer and Advancement Act 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). The Congressional Review Act, 5 U.S.C. 801 et seq. does not apply because this action is not a rule as that term is defined in 5 U.S.C. 804(3). List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Fenamiphos, Pesticides and pests, Reporting and recordkeeping requirements. Dated: February 24, 2012. Richard P. Keigwin, Jr., Director, Pesticide Re-evaluation Division, Office of Pesticide Programs. ADDRESSES: I. General Information ENVIRONMENTAL PROTECTION AGENCY A. Does this action apply to me? 40 CFR Part 180 [EPA–HQ–OPP–2010–0659; FRL–9336–6] Pyriofenone; Pesticide Tolerances Environmental Protection Agency (EPA). ACTION: Final rule. srobinson on DSK4SPTVN1PROD with RULES AGENCY: This regulation establishes tolerances for residues of pyriofenone, (5-chloro-2-methoxy-4-methyl-3pyridinyl)(2,3,4-trimethoxy-6methylphenyl) methanone, including its metabolites and degradates, in or on grape and grape, raisin. ISK BioSciences SUMMARY: VerDate Mar<15>2010 16:19 Mar 06, 2012 Jkt 226001 You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to those engaged in the following activities: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. 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 https://ecfr.gpoaccess.gov/cgi/t/ text/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–2010–0659 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 May 7, 2012. 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 that does not contain any 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 a copy of your non-CBI objection or hearing request, identified by docket ID number EPA–HQ–OPP–2010–0659, by one of the following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the on-line instructions for submitting comments. • Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001. • Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. E:\FR\FM\07MRR1.SGM 07MRR1

Agencies

[Federal Register Volume 77, Number 45 (Wednesday, March 7, 2012)]
[Rules and Regulations]
[Pages 13499-13502]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-5383]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0702; FRL-9339-7]


Fenamiphos; Data Call-in Order for Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final order.

-----------------------------------------------------------------------

SUMMARY: This order requires the submission of various data to support 
the continuation of the tolerances for the pesticide fenamiphos. 
Pesticide tolerances are established under the Federal Food, Drug, and 
Cosmetic Act (FFDCA). Following publication of this order, persons who 
are interested in the continuation of the fenamiphos tolerances must 
notify the Agency by completing and submitting the required section 
408(f) Order Response Form (available in the docket) within 90 days. If 
the Agency does not receive within 90 days after publication of the 
final order a section 408(f) Response Form identifying a person who 
agrees to submit the required data, EPA will revoke the fenamiphos 
tolerances.

DATES: This final order is effective March 7, 2012. A section 408(f) 
Order Response Form must be received on or before June 5, 2012.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2011-0702. All documents in the 
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at https://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.
    Submit your section 408(f) Order Response Form, identified by 
docket identification (ID) number EPA-HQ-OPP-2011-0702, by one of the 
following methods:
     Federal eRulemaking Portal: Follow the on-line 
instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave. 
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.
     Instructions: Direct your section 408(f) Order Response 
Form to docket ID number EPA-HQ-OPP-2011-0702. EPA's policy is that all 
information and comments received will be included in the docket 
without change and may be made available on-line at https://www.regulations.gov, including any personal information provided, 
unless the information or comment includes information claimed to be 
CBI or other information whose disclosure is restricted by statute. Do 
not submit information that you consider to be CBI or otherwise 
protected through regulations.gov or email. The regulations.gov Web 
site is an ``anonymous access'' system, which means EPA will not know 
your identity or contact information unless you provide it in the body 
of your comment. If you send information or comments via an email 
directly to EPA without going through regulations.gov, your email 
address will be automatically captured and included as part of the 
information or comment that is placed in the docket and made available 
on the Internet. If you submit information or a comment electronically, 
EPA recommends that you include your name and other contact information 
in the body of your information or comment and with any disk or CD-ROM 
you submit. If EPA cannot read your information or comment due to 
technical difficulties and cannot contact

[[Page 13500]]

you for clarification, EPA may not be able to consider your submission. 
Electronic files should avoid the use of special characters, any form 
of encryption, and be free of any defects or viruses.
     Docket: All documents in the docket are listed in the 
docket index available at https://www.regulations.gov. Although listed 
in the index, some information is not publicly available, e.g., CBI or 
other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available either in the 
electronic docket at https://www.regulations.gov, or, if only available 
in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Eric Miederhoff, Pesticide Re-
evaluation Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8028; email 
address: miederhoff.eric@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

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 cite at https://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the harmonized test guidelines referenced in 
this document electronically, please go to https://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines,'' which is listed under 
``Documents related to our mission.''

II. Background

A. What action is the agency taking?

    In this document EPA is issuing an order requiring the submission 
of various data to support the continuation of the fenamiphos 
tolerances at 40 CFR 180.349 under section 408 of the FFDCA, 21 U.S.C. 
346a.
    Fenamiphos is not currently registered under FIFRA, 7 U.S.C. 136 et 
seq. The FIFRA registration for fenamiphos was canceled in 2007. 
However, four FFDCA tolerances remain for residues of fenamiphos on the 
following commodities: Bananas, grapes, pineapples, and raisins (40 CFR 
180.349). Since there are currently no domestic registrations for 
fenamiphos, these tolerances are referred to as ``import tolerances.'' 
It is these tolerances that are addressed by the data call-in order.

B. What is the agency's authority for taking this action?

    Under section 408(f) of the FFDCA, EPA is authorized to require, by 
order, submission of data ``reasonably required to support the 
continuation of a tolerance'' when such data cannot be obtained under 
the Data Call-In authority of FIFRA section 3(c)(2)(B), or section 4 of 
the Toxic Substances Control Act (TSCA), 15 U.S.C. 2603. A FFDCA 
section 408 data call-in order may only be issued following publication 
of notice of the order and a 60-day public comment provision.
    A section 408(f) Data Call-In order must contain the following 
elements:
    1. A requirement that one or more persons submit to EPA a notice 
identifying the person(s) who commit to submit the data required in the 
order;
    2. A description of the required data and the required reports 
connected to such data;
    3. An explanation of why the required data could not be obtained 
under section 3(c)(2)(B) of FIFRA or section 4 of TSCA; and
    4. The required submission date for the notice identifying one or 
more interested persons who commit to submit the required data and the 
required submission dates for all the data and reports required in the 
order. (21 U.S.C. 346a(f)(1)(C)).
    EPA may by order modify or revoke the affected tolerances if any 
one of the following submissions is not made in a timely manner:
    i. A notice identifying the one or more interested persons who 
commit to submit the data;
    ii. The data itself; or
    iii. The reports required under a section 408(f) order are not 
submitted by the date specified in the order. (21 U.S.C. 346a(f)(2)).

C. What preliminary steps were taken by EPA prior to issuing this final 
order?

    On August 31, 2011, EPA issued a proposed data call-in order for 
the pesticide fenamiphos in connection with tolerances for that 
pesticide under section 408 of the FFDCA, 21 U.S.C. 346a. (75 FR 
44181). The proposed data call-in order included the following studies:
    1. Comparative Cholinesterase Assay (Non-Guideline).
    2. Immunotoxicity Study (870.7800).
    3. Crop Field Trials (860.1500)--(grapes; foliar use in Mexico).

III. Summary of Public Comments Received and Agency Response to 
Comments

    EPA received one comment in response to the August 31, 2011, 
Federal Register notice announcing the Agency's proposed data call-in 
order for fenamiphos (76 FR 54185; FRL-8886-2). However, this comment 
merely argued that there are too many toxic chemicals approved for use 
in the United States and did not, in any manner, address the Agency's 
intention to issue a data call-in order for fenamiphos. Therefore, no 
response to this comment is needed. In addition, the Agency has not 
received any of the data identified in the proposed order as needed to 
support the fenamiphos tolerances.

IV. Final Data Call-in Order

    Because no comments were submitted on the proposal and the data 
deficiencies identified in the proposed order remain, EPA is issuing 
this final data call-in order under FFDCA section 408(f)(1)(C) for 
fenamiphos in the same form as the proposed order and for the reasons 
set forth in that proposed order. Specifically, this order:
    1. Requires Notice of Intent to Submit Data. A notice identifying 
the person or

[[Page 13501]]

persons who commit to submit the data and reports in accordance with 
Unit V.2. must be submitted to EPA if any person wishes to support the 
fenamiphos tolerances. The notice must be submitted on a section 408(f) 
Order Response Form which is available in the electronic docket, https://www.regulations.gov, under docket ID number EPA-HQ-OPP-2011-0702.
    2. Establishes a Deadline for Submission of Notice Identifying Data 
Submitters. The notice described in Unit V.1. identifying data 
submitters must be submitted to and received by EPA on or before June 
5, 2012. Instructions on methods for submitting this notice (referred 
to in this order as a ``section 408(f) Order Response Form'') are set 
out under ADDRESSES.
    3. Describes Data and Reports Required to Support Continuation of 
the Fenamiphos Tolerances, Requires Submission of Those Data and 
Reports, and Establishes Deadlines for Submission. The table in this 
Unit describes the data and reports required to be submitted on 
fenamiphos under this order and the deadlines for the submission of 
each study and report. The required submission date is calculated from 
June 5, 2012. Thus, for example, if EPA generally allows 12 months to 
complete a study, the required submission date for such a study under 
this order would be 15 months from the date of publication of the order 
in the Federal Register.

----------------------------------------------------------------------------------------------------------------
                                                                                                   Timeframe for
     OCSPP Harmonized guideline No.               Study title           Timeframe for  protocol        data
                                                                          report  submission        submission
----------------------------------------------------------------------------------------------------------------
Non-Guideline...........................  Comparative Cholinesterase  12/7/2012.................        6/7/2013
                                           Assay.
870.7800................................  Immunotoxicity Study......  12/7/2012.................        6/7/2013
860.1500................................  Crop Field Trials (grapes;  Not Required..............        6/9/2014
                                           foliar use in Mexico).
----------------------------------------------------------------------------------------------------------------

    EPA provided a description of why the required data could not be 
obtained under section 3(c)(2)(B) of FIFRA or section 4 of TSCA in the 
proposed order and relies on that description in this final order.

V. Failure To Submit Notice of Intent To Submit Data or Data and 
Reports

    If, by June 5, 2012 the Agency does not receive a section 408(f) 
Order Response Form identifying a person who agrees to submit the 
required data, EPA will revoke the fenamiphos tolerances at 40 CFR 
180.349. Such revocation is subject to the objection and hearing 
procedure in FFDCA section 408(g)(2) but the only material issue in 
such a procedure is whether a submission required by the order was made 
in a timely fashion.
    Additional events that may be the basis for modification or 
revocation of fenamiphos tolerances include, but are not limited to the 
following:
    1. No person submits on the required schedule an acceptable 
protocol report when such report is required to be submitted to the 
Agency for review.
    2. No person submits on the required schedule acceptable data as 
required by the final order.

VI. Statutory and Executive Order Reviews

    This action, which requires the submission of data in support of 
tolerances in accordance with FFDCA section 408, is in the form of an 
order and not a rule. (21 U.S.C. 346a(f)(1)(C)). Under the 
Administrative Procedures Act (APA), orders are expressly excluded from 
the definition of a rule. (5 U.S.C. 551(4)). Accordingly, the 
regulatory assessment requirements imposed on a rulemaking do not apply 
to this action, as explained further in the following discussion.

A. Executive Order 12866: Regulatory Planning and Review and Executive 
Order 13563: Improving Regulation and Regulatory Review

    Because this order is not a ``regulatory action'' as that term is 
defined in Executive Order 12866 (58 FR 51735, October 4, 1993), this 
action is not subject to review by the Office of Management and Budget 
(OMB) under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 
2011).

B. Paperwork Reduction Act

    This action does not impose additional burdens that require 
approval by OMB under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 
et seq.). The information collection activities associated with the 
order requesting data from any party interested in supporting certain 
tolerances are already approved by OMB under OMB Control No. 2070-0174, 
and are identified by EPA ICR No. 2288.01. Burden is defined at 5 CFR 
1320.3(b). Under the PRA, an Agency may not conduct or sponsor, and a 
person is not required to respond to a collection of information that 
requires OMB approval under PRA, unless it has been approved by OMB and 
displays a currently valid OMB control number. The OMB control numbers 
for EPA's regulations in title 40 of the CFR, after appearing in the 
Federal Register, are listed in 40 CFR part 9, and included on the 
related collection instrument, or form, if applicable.

C. Regulatory Flexibility Act

    Since this order is not a rule under the APA (5 U.S.C. 551(4)), and 
does 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.

D. Unfunded Mandates Reform Act; Executive Order 13132: Federalism; and 
Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

    This order requests data from any party interested in supporting 
certain tolerances and does not impose obligations on any person or 
entity including States or tribes; nor does this action alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of section 408(n)(4) of FFDCA. 
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 (64 FR 43255, August 10, 1999) and Executive Order 13175 (65 FR 
67249, November 9, 2000) do not apply to this order. In addition, this 
order 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. 1531-1538).

[[Page 13502]]

E. Executive Order 13045: Protection of Children From Environmental 
Health Risks and Safety Risks; Executive Order 13211: Actions 
Concerning Regulations That Significantly Affect Energy Supply, 
Distribution, or Use; and Executive Order 12898: Federal Actions To 
Address Environmental Justice in Minority Populations and Low-Income 
Populations

    As indicated previously, this action is not a ``regulatory action'' 
as defined by Executive Order 12866. As a result, this action is not 
subject to Executive Order 13045 (62 FR 19885, April 23, 1997) and 
Executive Order 13211 (66 FR 28355, May 22, 2001). In addition, this 
order also does not require any special considerations under Executive 
Order 12898 (59 FR 7629, February 16, 1994).

F. National Technology Transfer and Advancement Act

    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). The Congressional Review Act, 5 
U.S.C. 801 et seq. does not apply because this action is not a rule as 
that term is defined in 5 U.S.C. 804(3).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Fenamiphos, Pesticides and pests, Reporting 
and recordkeeping requirements.

    Dated: February 24, 2012.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2012-5383 Filed 3-6-12; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.