[Federal Register Volume 77, Number 130 (Friday, July 6, 2012)]
[Proposed Rules]
[Pages 39962-39965]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-16295]



40 CFR Part 180

[EPA-HQ-OPP-2012-0441; FRL-9352-9]

Difenzoquat; 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 to support the continuation of the tolerances for the pesticide 
difenzoquat. Pesticide tolerances are established under the Federal 
Food, Drug, and Cosmetic Act (FFDCA).

DATES: Comments must be received on or before September 4, 2012.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2012-0441; FRL-9352-9, by one of the following 
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), Mail Code: 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.htm.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

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: [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, 
those involved with:
     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 email. 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

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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 
difenzoquat tolerances at 40 CFR 180.369. Under section 408(f) of the 
Federal Food, Drug, and Cosmetic Act (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.
    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 difenzoquat in the Federal Register. 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 
    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)).
    If EPA issues such an order, persons who are interested in the 
continuation of the difenzoquat tolerances must notify the Agency by 
completing and submitting the required ``Sec.  408(f) Order Response'' 
form (available in the docket) within 90 days after publication in the 
Federal Register.
    The ``Sec.  408(f) Order Response Form'' requires the 
identification of persons who will submit the required data and lists 
the following options available to support the required data:
    a. Develop new data,
    b. Submit an existing study--submit existing data not submitted 
previously to the Agency by anyone,
    c. Upgrade a study--submit or cite data to upgrade a study 
classified by EPA as partially acceptable and upgradable,
    d. Cite an existing study--cite an existing study that EPA 
classified as acceptable or an existing study that has been submitted 
but not reviewed by the Agency.
    If EPA does issue a final order requiring the submission of data on 
difenzoquat and if the Agency does not receive a Sec.  408(f) Order 
Response Form identifying a person who agrees to submit the required 
data within 90 days after publication of the final order, EPA will 
proceed to revoke the difenzoquat tolerances at 40 CFR 180.369. Such 
revocation order 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 difenzoquat tolerances if a final order requiring data is 
issued 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.

III. Regulatory Background for Difenzoquat

    Difenzoquat is an herbicide. It is not currently registered under 
FIFRA. Difenzoquat's last FIFRA registration was canceled in 2010. 
However, 25 FFDCA tolerances remain for residues of difenzoquat on the 
following commodities: barley, cattle, goat, hog, horse, poultry, 
sheep, and wheat (40 CFR 180.369). Since there are currently no 
domestic registrations for difenzoquat, these tolerances are referred 
to as ``import tolerances.''
    The Agency completed a Reregistration Eligibility Decision (RED) 
for difenzoquat in September 1994. The RED evaluated the potential 
human health and ecological risks associated with all registered uses 
of difenzoquat, and concluded that difenzoquat products, when labeled 
and used as specified in the RED, did not pose unreasonable risk or 
adverse effects to humans or the environment. Additionally, in 
connection with its obligation under the Food Quality Protection Act of 
1996 (FQPA), the Agency evaluated whether all difenzoquat tolerances in 
existence at the time of the passage of FQPA met the revised safety 
standard that the FQPA adopted for FFDCA section 408. A Report of the 
Food Quality Protection Act (FQPA) Tolerance Reassessment Progress and 
Risk Management Decision (TRED) for Difenzoquat was completed in April 
2002. The TRED concluded that the risks of difenzoquat met the revised 
safety standard in FFDCA section 408.
    In August 2011, in response to a registrant's interest in 
supporting tolerances for import purposes, the Agency completed a 
screening-level evaluation for difenzoquat. As there are no domestic 
registrations for difenzoquat products, the evaluation was limited to 
the potential dietary risk from exposure to difenzoquat residues in 
imported food commodities. The evaluation concluded that additional 
data are needed to support a new dietary risk assessment on exposure 
from imported food commodities. The necessary data include: a 
neurotoxicity battery; residue data for wheat hay, wheat forage, and 
barley hay; and an immunotoxicity study. These data

[[Page 39964]]

requirements are discussed in detail in Unit IV.

IV. Proposed Data Requirements

A. Proposed 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 difenzoquat, which are codified at 40 CFR 
180.369. These data cannot be obtained under FIFRA section 3(c)(2)(B) 
because difenzoquat 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. Neurotoxicity Screening Battery (870.6200). Rationale. EPA does 
not have a neurotoxicity screening battery (870.6200) for difenzoquat. 
This is a 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 establishment of FFDCA tolerances. 40 CFR 158.500. The 
Neurotoxicity Screening Battery (870.6200) is designed to evaluate the 
potential adverse effects on the nervous system from exposure to 
pesticide chemicals. The acute neurotoxicity study is required to 
detect possible effects resulting from a single exposure. The 
subchronic neurotoxicity study is intended to detect possible effects 
resulting from repeated or long-term exposure.
    2. Immunotoxicity Study (870.7800). A final report and protocol are 
required. Rationale. EPA does not have a functional immunotoxicity 
study (870.7800) for difenzoquat. This is a 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. 40 CFR 158.500. A functional immunotoxicity study under the 
Immunotoxicity Test Guideline (870.7800) 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.
    3. Crop Field Trials (860.1500)--(wheat hay, wheat forage, and 
barley hay) Rationale. EPA does not have crop field trials (860.1500) 
for difenzoquat for the commodities wheat hay, wheat forage, or barley 
hay. 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.
    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 generally needed 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 
so that EPA can evaluate what level of residues may be present from use 
of the pesticide. 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 
number and location of field trials.
    EPA is requesting comment on these proposed data requirements.

B. Proposed Dates for Submission of Data/Reports

    The table below lists the time proposed for both the completion and 
submission of each study. The proposed submission date is calculated 
from the date of publication in the Federal Register of the final 

                                                                                                  Timeframe  for
   Guideline  requirement No.           Study title           Timeframe for protocol submission     submission
870.6200.......................  Neurotoxicity Screening    Not Required........................              24
870.7800.......................  Immunotoxicity Study.....  6 months............................              12
860.1500.......................  Crop Field Trials (wheat   Not Required........................              24
                                  hay, wheat forage, and
                                  barley hay).

V. Statutory and Executive Order Reviews

    As required by statute, this document proposing to require 
submission of data in support of tolerances is in the form of a 
proposed 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.
    This document proposes to require data from any party interested in 
supporting certain tolerances. Because this proposed order is not a 
significant regulatory action it is exempt from review by the Office of 
Management and Budget (OMB) under Executive Order 12866, entitled 
Regulatory Planning and Review (58 FR 51735, October 4, 1993), and also 
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 proposed order also does not 
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). 
This proposed order does contain information collections that have been 
approved by OMB under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 
et seq.
    This document proposes to require 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

[[Page 39965]]

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 
proposed final rule. In addition, this proposed order 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) (Pub. L. 
    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), Public Law 104-113, section 12(d) (15 U.S.C. 272 

List of Subjects in 40 CFR Part 180

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

    Dated: June 22, 2012.
Michael Goodis,
Director, Pesticide Re-evaluation Division, Office of Pesticide 
[FR Doc. 2012-16295 Filed 7-5-12; 8:45 am]