[Federal Register Volume 76, Number 169 (Wednesday, August 31, 2011)]
[Proposed Rules]
[Pages 54185-54188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22127]



40 CFR Part 180

[EPA-HQ-OPP-2011-0702; FRL-8886-2]

Fenamiphos; Proposed Data Call-In Order for Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed order.


SUMMARY: This document proposes to require the submission of various 
data required to support the continuation of the tolerances for the 
pesticide fenamiphos. Pesticide tolerances are established under the 
Federal Food, Drug, and Cosmetic Act (FFDCA).

DATES: Comments must be received on or before October 31, 2011.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2011-0702, by one of the following methods:
     Federal eRulemaking Portal: http://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. 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 comments to docket ID number EPA-HQ-OPP-
2011-0702. EPA's policy is that all 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 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 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 an e-
mail comment directly to EPA without going through regulations.gov, 
your e-mail address will be automatically captured and included as part 
of the comment that is placed in the docket and made available on the 
Internet. If you submit an electronic comment, EPA recommends that you 
include your name and other contact information in the body of your 
comment and with any disk or CD-ROM you submit. If EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, EPA may not be able to consider your comment. 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.),

[[Page 54186]]

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) 

evaluation Division (7508P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave, NW., 
Washington, DC 20460-0001; telephone number: (703) 347-8028; e-mail 
address: [email protected].


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 

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through 
regulations.gov or e-mail. Clearly mark the part or all of the 
information that you claim to be CBI. For CBI information in a disk or 
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as 
CBI and then identify electronically within the disk or CD-ROM the 
specific information that is claimed as CBI. In addition to one 
complete version of the comment that includes information claimed as 
CBI, a copy of the comment that does not contain the information 
claimed as CBI must be submitted for inclusion in the public docket. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments, 
remember to:
    i. Identify the document by docket ID number and other identifying 
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to 
specific questions or organize comments by referencing a Code of 
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and 
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information 
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you 
arrived at your estimate in sufficient detail to allow for it to be 
    vi. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of 
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period 
deadline identified.

II. FFDCA Data Call-In Authority

    In this document, EPA proposes to issue an order requiring the 
submission of various data to support the continuation of the 
fenamiphos tolerances at 40 CFR 180.349. Under section 408(f) of FFDCA, 
21 U.S.C. 346a(f), 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 section 3(c)(2)(B) of the Federal Insecticide, Fungicide, 
and Rodenticide Act (``FIFRA''), 7 U.S.C. 136a(c)(2)(B), or section 4 
of the Toxic Substances Control Act (``TSCA''), 15 U.S.C. 2603. A 
section 408(f) Data Call-In order may only be issued following notice 
and a comment period of not less than 60 days.
    A section 408(f) Data Call-In order must contain the following 
     A requirement that one or more persons submit to EPA a 
notice identifying the person(s) who commit(s) to submit the data 
required in the order;
     A description of the required data and the required 
reports connected to such data;
     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
     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:
     A notice identifying the one or more interested persons 
who commit to submit the data;
     The data itself; or
     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)).

III. Regulatory Background for Fenamiphos

    Fenamiphos is an organophosphate nematicide/insecticide. It is not 
currently registered under FIFRA. Fenamiphos' last FIFRA registration 
was canceled in 2007. However, four FFDCA tolerances remain for 
residues of fenamiphos on the following commodities: Pineapples, 
grapes, raisins, and bananas (40 CFR 180.349). Since there are 
currently no domestic registrations for fenamiphos, these tolerances 
are referred to as ``import tolerances.''
    Fenamiphos is a member of a family of pesticides known as the 
organophosphates. EPA has concluded fenamiphos and other 
organophosphate pesticides share a common mechanism of toxicity. As 
with other organophosphates, the principal toxic effects induced by 
fenamiphos are related to its cholinesterase-inhibiting activity. In 
animal laboratory studies, it produces the associated clinical signs 
such as tremors, unsteady gait, decreased activity, salivation, and 
disturbed balance in rats and rabbits, and decreased cholinesterase 
activity (plasma, brain) in rats and rabbits following acute, 
subchronic, and chronic oral exposure.
    In February 2002, EPA issued an Interim Reregistration Eligibility 
Decision (IRED) for fenamiphos. The IRED evaluated the potential human 
health and ecological risks associated with all registered uses of 
fenamiphos. In connection with its obligation under the Food Quality 
Protection Act of 1996 (FQPA), the Agency also evaluated whether all 
fenamiphos tolerances in existence at the time of the passage of FQPA 
met the revised safety standard that the FQPA adopted for FFDCA section 
408. In the IRED, EPA concluded that the risks of fenamiphos when 
evaluated in isolation from other organophosphates met the revised 
safety standard in FFDCA section 408. This

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conclusion was labeled ``interim,'' however, because EPA had not yet 
completed a cumulative risk assessment for the organophosphates. In 
July 2006, EPA completed its cumulative risk assessment for the 
organophosphate pesticides finding that these tolerances met the 
revised safety standard.
    In June 2010, in response to a registrant's interest in supporting 
tolerances for import purposes, the Agency completed a revised human 
health risk assessment for fenamiphos. As there are no domestic 
registrations for fenamiphos products, the assessment was limited to an 
evaluation of the potential dietary risk from exposure to fenamiphos 
residues in imported food commodities. This assessment utilized updated 
risk assessment methodologies from those that were used for the IRED's 
dietary assessment. The 2010 assessment concluded that potential 
exposure to fenamiphos residues in or on imported food commodities 
exceeds the Agency's level of concern.
    The 2010 assessment identified several studies that were needed to 
verify the accuracy of the assumptions used in the Agency's evaluation 
of dietary exposure to imported commodities treated with fenamiphos or 
that were needed to meet a new data requirement. The necessary data 
include: A comparative chlolinesterase assay, residue data for grape, 
and an immunotoxicity study. These data requirements are discussed in 
detail in Unit IV.
    Under section 3(g) of FIFRA and implementing regulations, EPA has 
established a review program for pesticides registered under FIFRA. The 
goal of that program is for there to be a periodic review of pesticide 
registrations every 15 years to ensure that the registrations satisfy 
FIFRA standards and are based on ``current scientific and other 
knowledge regarding the pesticide.'' (40 CFR 155.40(a)). EPA is in the 
preliminary stages of the registration review process for 
organophosphate pesticides. Although fenamiphos is not registered under 
FIFRA, EPA will be reexamining fenamiphos with the other registered 
organophosphates because of the organophosphates' shared mechanism of 

IV. Data Requirements

A. Required Data and Reports

    Pursuant to FFDCA section 408(f), EPA has determined that 
additional data are reasonably required to support the continuation of 
the import tolerances for fenamiphos which are codified at 40 CFR 
180.349. These data cannot be obtained under FIFRA section 3(c)(2)(B) 
because fenamiphos is not registered under FIFRA, and the data call-in 
authority under that section only extends to registered pesticides. 
These data cannot be obtained under TSCA because pesticides are 
excluded from coverage under that statute. 15 U.S.C. 2602(2)(B)(ii).
    Accordingly, EPA proposes to issue a final order requiring the 
submission of the following data:
    1. Comparative Cholinesterase Assay (870.6300). A protocol and a 
final report are required.
    Rationale: As an organophosphate pesticide (OP), inhibition of 
acetylcholinesterase (AChE) is the critical effect for use in human 
health risk assessment. Many OPs were subject to a Data Call-In for the 
developmental neurotoxicity study (DNT). This Data Call-In also 
included the requirement for AChE inhibition data to evaluate 
comparative sensitivity in juvenile and adult rats. These data are most 
often collected in a study called the comparative cholinesterase assay 
(CCA). Since that time, CCA studies for more than 20 OPs have been 
submitted. Although for some OPs no difference in sensitivity has been 
observed in juvenile and adult animals, for many of the OPs, juveniles 
have been shown to be more sensitive. At this time, OPP has determined 
that a CCA is required for fenamiphos to evaluate the potential for 
increased sensitivity in juvenile animals compared with that of adult 
animals. Given that the AChE data provided in the CCAs have provided 
more sensitive results than DNT studies for the OPs, a DNT study for 
fenamiphos is not required at this time.
    2. Immunotoxicity study (870.7800). A final report and protocol are 
    Rationale: This is a new data requirement under 40 CFR part 158 as 
a part of the data requirements for registration of a pesticide (food 
and non-food uses) and for establishment of a tolerance.
    The Immunotoxicity Test Guideline (OPPTS 870.7800) prescribes 
functional immunotoxicity testing and is designed to evaluate the 
potential of a repeated chemical exposure to produce adverse effects 
(i.e., suppression) on the immune system. Immunosuppression is a 
deficit in the ability of the immune system to respond to a challenge 
of bacterial or viral infections such as tuberculosis (TB), Severe 
Acquired Respiratory Syndrome (SARS), or neoplasia. An immunotoxicity 
study for fenamiphos has not been submitted.
    3. Crop field trials--grapes (860.1500). A final report is 
    Rationale: Field trials are required for each commodity/commodity 
group under 40 CFR part 158. These data are used to establish the legal 
maximum residue that may remain on food and to assess the risk posed by 
the pesticide residue. While residue data for fenamiphos use on grape 
is adequate to support several application methods, the Agency has not 
received data to support the current foliar use of fenamiphos on grape 
in Mexico.
    EPA guidelines recommend that crop field trials be designed to take 
into account where the crop is grown and how much of the crop is grown. 
Field trials are required for each type of formulation because the 
formulation can have a significant effect on the magnitude of the 
pesticide residue left on the crop. Residue trials also need to 
represent the maximum application rate on the label and have a 
geographic distribution representative of the commodity/commodity 
group. On June 1, 2000 (65 FR 35069) (FRL-6559-3), EPA published in the 
Federal Register a Notice which provided detailed guidance on applying 
current U.S. data requirements for the establishment or continuance of 
tolerances for pesticide residues in or on imported foods. A copy of 
that Notice is available in the docket of this proposed order. That 
Notice contains instructions for determining the number and location of 
field trials.

B. Persons Who Commit To Submit the Required Data

    After the 60-day comment period closes, the Agency will respond to 
comments, if appropriate, and may issue a final order requiring the 
submission of various data for fenamiphos in the Federal Register. If 
EPA issues such an 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 after 
publication of the final Order in the Federal Register.
    The ``Section 408(f) Order Response Form'' requires the 
identification of persons who will submit the required data and lists 
the options available to support the required data:
    1. Develop new data.
    2. Submit an existing study--submit existing data not submitted 
previously to the Agency by anyone.
    3. Upgrade a study--submit or cite data to upgrade a study 
classified by EPA as partially acceptable and upgradable.
    4. Cite an existing study--cite an existing study that EPA 
classified as

[[Page 54188]]

acceptable or an existing study that has been submitted but not 
reviewed by the Agency.

C. Required Dates for Submission of Data/Reports

    The following table lists the time allocated for both the 
completion and submission of each study. The required submission date 
is calculated from the date of publication in the Federal Register of 
the final order.

                                                               Timeframe for
     Guideline requirement No.           Study title        protocol submission    Timeframe for data submission
870.6300..........................  Comparative            6 months.............  12 months.
                                     Cholinesterase Assay.
870.7800..........................  Immunotoxicity Study.  6 months.............  12 months.
860.1500..........................  Crop Field Trials      Not Required.........  24 months.

D. Failure To Submit

    If the Agency does not receive a Section 408(f) Response Form 
identifying a person who agrees to submit the required data within 90 
days after publication of the final order in the Federal Register, EPA 
will proceed to revoke the fenamiphos tolerances at 40 CFR 180.349. 
Such revocation order is subject to the objection and hearing 
procedures 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 
proposal or final protocol when such is required to be submitted to the 
Agency for review.
    2. No person submits on the required schedule an adequate progress 
report on a study as required by the order.
    3. No person submits on the required schedule acceptable data as 
required by the final order.
    4. No person submits supportable certifications as to the 
conditions of submitted data, where required by order and where no 
other cited or submitted study meets the data requirements the study 
was intended to fulfill.

V. Statutory and Executive Order Reviews

    As required by statute, this proposal to require 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 
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: August 22, 2011.
Peter Caulkins,
Acting Director, Pesticide Re-evaluation Division, Office of Pesticide 
[FR Doc. 2011-22127 Filed 8-30-11; 8:45 am]