[Federal Register Volume 76, Number 125 (Wednesday, June 29, 2011)]
[Rules and Regulations]
[Pages 38037-38040]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-16355]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2010-0423; FRL-8879-2]


 Mevinphos; 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 mevinphos. 
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 mevinphos 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 mevinphos 
tolerances.

DATES: This final order is effective June 29, 2011. A section 408(f) 
Order Response form must be received on or before September 27, 2011.

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2010-0423. All documents in the 
docket are listed in the docket index available at http://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 http://www.regulations.gov, or, if only available in hard 
copy, at the OPP

[[Page 38038]]

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-2010-0423, 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-2010-0423. 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 http://www.regulations.gov, including any personal information provided, 
unless the information or comment includes information claimed to be 
Confidential Business Information (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 e-
mail. The regulations.gov website 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 e-mail directly to EPA without going 
through regulations.gov, your e-mail 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 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 http://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 http://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: Susan Bartow, Pesticide Re-evaluation 
Division (7508P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 603-0065; fax number: (703) 308-8090; e-
mail address: bartow.susan@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 http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl http://www.gpoaccess.gov/ecfr. To access the harmonized 
test guidelines referenced in this document electronically, please go 
to http://www.epa.gov/ocspp and select ``Test Methods and Guidelines.''

II. Background

A. What action is the agency taking?

    In this document EPA issues an order requiring the submission of 
various data to support the continuation of the mevinphos tolerances at 
40 CFR 180.157 under section 408 of the Federal Food, Drug, and 
Cosmetic Act (``FFDCA''), 21 U.S.C. 346a.
    Mevinphos is not currently registered under the Federal 
Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 U.S.C. 136 
et seq., and may not be sold, distributed, or used in the United 
States. Mevinphos' FIFRA registration was canceled in 1994. However, 15 
FFDCA tolerances remain for residues of mevinphos on the following 
commodities: Broccoli, cabbage, cauliflower, celery, spinach, 
strawberries, grapes, lettuce, melons, watermelon, peas, peppers, 
summer squash, cucumbers, and tomatoes (40 CFR 180.157). Since there 
are currently no domestic registrations for mevinphos, 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:

[[Page 38039]]

    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 are not made in a timely manner:
    1. A notice identifying the one or more interested persons who 
commit to submit the data;
    2. The data itself; or
    3. 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 July 28, 2010, EPA issued a proposed data call-in order for the 
pesticide mevinphos 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 (870.6300);
    2. Immunotoxicity Study (870.7800);
    3. Directions for Use (860.1200);
    4. Crop Field Trials (860.1500)--(broccoli, cabbage, cauliflower, 
celery, grapes, lettuce, peas, peppers, spinach, summer squash, 
strawberries, and tomatoes); and
    5. Processing Study (tomatoes) (860.1520).

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

    EPA received no comments in response to the July 28, 2010 Federal 
Register notice announcing the Agency's proposed data call-in order for 
mevinphos. In addition, the Agency has not received any of the data 
identified in the proposed order as needed to support the mevinphos 
tolerances.

IV. Final Data Call-in Order

    Because no comments were submitted on the proposed order and the 
data deficiencies identified in the proposed order remain, EPA is today 
issuing the final data call-in order under FFDCA section 408(f)(1)(C) 
for mevinphos in the same form as the proposed order and for the 
reasons set forth in that proposed order. Specifically, EPA is 
requiring:
    1. Notice of intent to submit data. A notice identifying the person 
or 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 
mevinphos tolerances. The notice must be submitted on a section 408(f) 
Order Response form which is available on the Federal Government's 
electronic docket, http:/www.regulations.gov, under docket ID number 
EPA-HQ-OPP-2010-0423.
    2. 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 29, 2011. 
Instructions on methods for submitting this notice (referred to in this 
order as a ``section 408(f) Order Response form'') are set out under 
the ADDRESSES heading above.
    3. Required data and reports and readlines for submission. The 
table below lists the data and reports required to be submitted on 
mevinphos under this order and the deadlines for the submission of each 
study and report. The required submission date is calculated from the 
close of the 90-day period following Federal Register publication of 
the order for providing notice of intent to submit the data. 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.

                                        Table--Required Data and Reports
----------------------------------------------------------------------------------------------------------------
     Harmonized guideline                              Timeframe for  protocol
        requirement No.             Study title           report  submission       Timeframe for data submission
----------------------------------------------------------------------------------------------------------------
870.6300......................  Comparative         March 29, 2012...............  October 1, 2012.
                                 Cholinesterase
                                 Assay.
870.7800......................  Immunotoxicity      March 29, 2012...............  October 1, 2012.
                                 Study.
860.1200......................  Directions for use  Not required.................  October 1, 2012.
860.1500......................  Crop Field Trials   Not Required.................  September 30, 2013.
                                 (broccoli,
                                 cabbage,
                                 cauliflower,
                                 celery, grapes,
                                 lettuce, peas,
                                 peppers, spinach,
                                 summer squash,
                                 strawberries, and
                                 tomatoes).
860.1520......................  Processing studies  Not Required.................  September 30, 2013.
                                 (tomatoes).
----------------------------------------------------------------------------------------------------------------

    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, within 90 days after publication of this final order, 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 mevinphos tolerances at 40 CFR 180.157. 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 mevinphos 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

    As required by statute, this action requiring submission of data in 
support of tolerances is in the form of an order and not a rule. (21 
U.S.C. 346a(f)(1)(C)). Under the Administrative Procedures Act, orders 
are expressly excluded from the definition of a rule. (5 U.S.C. 
551(4)). Accordingly, the regulatory assessment requirements imposed on

[[Page 38040]]

rulemaking do not, therefore, apply to this action.

List of Subjects in 40 CFR Part 180

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

    Dated: June 22, 2010.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2011-16355 Filed 6-28-11; 8:45 am]
BILLING CODE 6560-50-P