Document ID: EPA-HQ-OPP-2011-0374-0012
Agency: epa
Document Type: Notice
Title: Pesticide Product Registration: Dimethyl Tetrachloroterephthalate; Suspension
Posted Date: 2022-04-28T04:00Z

[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25262-25266]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09069]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2011-0374; FRL-9758-01-OCSPP]

Notice of Intent To Suspend Dimethyl Tetrachloroterephthalate 
(DCPA) Technical Registration

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice, pursuant the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA), publishes a Notice of Intent to Suspend a 
pesticide registration issued by EPA containing dimethyl 
tetrachloroterephthalate (DCPA). The Notice of Intent to Suspend was 
issued following the Agency's January 21, 2013, issuance of a Data

[[Page 25263]]

Call-In Notice (DCI), which required the registrant of the affected 
pesticide product containing DCPA to take appropriate steps to secure 
certain data. Following the registrant's failure to submit these data 
or to take other appropriate steps to secure the required data, the 
agency is unable to fully evaluate the risks associated with DCPA. Data 
for DCPA were determined to be required to maintain the existing 
registration of the affected product. In particular, due to the lack of 
complete data examining thyroid toxicity of DCPA, the Agency is not 
able to complete a scientifically robust and defensible human health 
risk assessment. Preliminary data evaluated by EPA provides evidence 
that, in animal studies, the fetus is potentially more sensitive to 
DCPA's effect on thyroid function compared to the mother. Given this 
potential fetal sensitivity, EPA has concerns for exposures to pregnant 
females and effects on the developing fetus. Based on EPA's review of 
the preliminary data, applying a standard uncertainty factor (typically 
a ten-fold factor) to account for these missing data may not be 
adequate to account for these effects. The failure of the registrant to 
comply with the thyroid toxicity and other data requirements of the 
DCPA DCI is a basis for suspension of the affected registration under 
FIFRA.

DATES: The Notice of Intent to Suspend included in this Federal 
Register notice will become a final and effective suspension order 
automatically by operation of law 30 days after the date of the 
registrant's receipt of the Notice of Intent to Suspend or, if the EPA 
Administrator otherwise is unable to accomplish delivery to the 
registrant after making reasonable efforts to do so, the Notice of 
Intent to Suspend becomes effective 30 days after the date of 
publication of this notice in the Federal Register, unless, during that 
time, a timely and adequate request for a hearing is made by a person 
adversely affected by the Notice of Intent to Suspend, or the 
registrant has satisfied the EPA Administrator that the registrant has 
complied fully with the requirements that served as a basis for the 
Notice of Intent to Suspend. Unit IV. explains what must be done to 
avoid suspension under this notice (i.e., how to request a hearing or 
how to comply fully with the requirements that served as a basis for 
the Notice of Intent to Suspend).

FOR FURTHER INFORMATION CONTACT: James Douglass, Pesticide Re-
evaluation Division (7508M), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, 
DC 20460-0001; main telephone number: (202) 566-2343; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general and may be of 
interest to a wide range of stakeholders including environmental, human 
health, farm worker and agricultural advocates; the chemical industry; 
pesticide users; and members of the public interested in the sale, 
distribution, or use of pesticides. Since others also may be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action.

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification 
(ID) number EPA-HQ-OPP-2011-0374, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. Due to public 
health concerns related to COVID-19, the EPA/DC and Reading Room are 
open to the public by appointment only, and walk-ins are not allowed. 
Visitors to the Reading Room must complete docket material requests in 
advance and then make an appointment to retrieve the material. Please 
contact the EPA Reading Room staff at (202) 566-1744 or via the Dockets 
Customer Service email at [email protected] to arrange 
material requests and appointments. Please review the visitor 
instructions and additional information available at https://www.epa.gov/dockets/epa-docket-center-and-reading-room-open-public-appointment-only.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

II. Registrant Issued Notice of Intent To Suspend Active Ingredient, 
Product Affected, and Date Issued

    The registrant and product subject to this Notice of Intent to 
Suspend are listed in Table 1. A Notice of Intent to Suspend was sent 
to the registrant of the affected product.

                          Table 1--List of Registrant and Product Subject to Suspension
----------------------------------------------------------------------------------------------------------------
                                                   EPA registration                      Date EPA issued notice
   Registrant affected       Active ingredient          number          Product name      of intent to suspend
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AMVAC Chemical             DCPA (or chlorthal-              5481-495  TECHNICAL         April 28, 2022.
 Corporation.               dimethyl).                                 CHLORTHAL
                                                                       DIMETHYL.
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III. Basis for Issuance of Notice of Intent To Suspend; Requirement 
List

    The registrant failed to submit the data or information required by 
the Data-Call-In Notice (GDCI-078701-1140, available at https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0009), or to take 
other appropriate steps to secure the required data for their pesticide 
product listed in Table 2 of this unit.

[[Page 25264]]

                                                              Table 2--List of Requirements
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                                   Guideline number                                                                                    Reason for notice
      EPA registration No.           as listed in      Requirement name     Date EPA issued     Date registrant     Final data due       of intent to
                                    applicable DCI                                DCI            received DCI            date               suspend
--------------------------------------------------------------------------------------------------------------------------------------------------------
5481-495........................  835.4200..........  Anaerobic soil      January 31, 2013..  January 31, 2013..  January 31, 2015..  Inadequate data
                                                       metabolism (TPA).                                                               received.
5481-495........................  835.4300..........  Aerobic aquatic     January 31, 2013..  January 31, 2013..  January 31, 2015..  Inadequate 90-day
                                                       metabolism (TPA).                                                               response
                                                                                                                                       received. No data
                                                                                                                                       received.
5481-495........................  835.4400..........  Anaerobic aquatic   January 31, 2013..  January 31, 2013..  January 31, 2015..  Inadequate 90-day
                                                       metabolism (TPA).                                                               response
                                                                                                                                       received. No data
                                                                                                                                       received.
5481-495........................  850.1350..........  Chronic toxicity    January 31, 2013..  January 31, 2013..  January 31, 2014..  Inadequate data
                                                       mysid (DCPA).                                                                   received.
5481-495........................  850.1350..........  Chronic toxicity    January 31, 2013..  January 31, 2013..  January 31, 2014..  Inadequate 90-day
                                                       mysid (TPA).                                                                    response
                                                                                                                                       received. No data
                                                                                                                                       received.
5481-495........................  850.1400..........  Fish early life-    January 31, 2013..  January 31, 2013..  January 31, 2014..  No data received.
                                                       stage (bluegill
                                                       sunfish) (DCPA).
5481-495........................  850.1400..........  Fish early life-    January 31, 2013..  January 31, 2013..  January 31, 2014..  No data received.
                                                       stage (sheepshead
                                                       minnow) (DCPA).
5481-495........................  850.1400..........  Fish early life-    January 31, 2013..  January 31, 2013..  January 31, 2014..  Inadequate 90-day
                                                       stage (rainbow                                                                  response
                                                       trout) (TPA).                                                                   received. No data
                                                                                                                                       received.
5481-495........................  850.1400..........  Fish early life-    January 31, 2013..  January 31, 2013..  January 31, 2014..  Inadequate 90-day
                                                       stage (bluegill                                                                 response
                                                       sunfish) (TPA).                                                                 received. No data
                                                                                                                                       received.
5481-495........................  850.1400..........  Fish early life-    January 31, 2013..  January 31, 2013..  January 31, 2014..  Inadequate 90-day
                                                       stage (sheepshead                                                               response
                                                       minnow) (TPA).                                                                  received. No data
                                                                                                                                       received.
5481-495........................  850.2100..........  Acute avian oral    January 31, 2013..  January 31, 2013..  January 31, 2014..  Inadequate data
                                                       toxicity                                                                        received.
                                                       (passerine
                                                       species) (DCPA).
5481-495........................  850.4100..........  Seedling Emergence  January 31, 2013..  January 31, 2013..  January 31, 2014..  Inadequate data
                                                       (DCPA) [lettuce                                                                 received.
                                                       only].
5481-495........................  850.4500 (formerly  Algal toxicity      January 31, 2013..  January 31, 2013..  January 31, 2014..  Inadequate 90-day
                                   850.5400).          test, Tier I/II                                                                 response
                                                       (TPA) [marine                                                                   received. No data
                                                       diatom only].                                                                   received.
5481-495........................  860.1300..........  Nature of the       January 31, 2013..  January 31, 2013..  January 31, 2015..  Inadequate 90-day
                                                       residue: poultry.                                                               response
                                                                                                                                       received. No data
                                                                                                                                       received.
5481-495........................  860.1340..........  Residue analytical  January 31, 2013..  January 31, 2013..  January 31, 2015..  Inadequate 90-day
                                                       method: livestock                                                               response
                                                       commodities.                                                                    received. No data
                                                                                                                                       received.
5481-495........................  860.1480..........  Meat/milk/poultry/  January 31, 2013..  January 31, 2013..  January 31, 2015..  Inadequate 90-day
                                                       eggs.                                                                           response
                                                                                                                                       received. No data
                                                                                                                                       received.
5481-495........................  860.1900..........  Field accumulation  January 31, 2013..  January 31, 2013..  January 31, 2016..  Inadequate 90-day
                                                       in rotational                                                                   response
                                                       crops.                                                                          received;
                                                                                                                                       inadequate data
                                                                                                                                       received.
5481-495........................  Non-guideline.....  Chronic Sediment    January 31, 2013..  January 31, 2013..  January 31, 2015..  Inadequate data
                                                       toxicity--Chirono                                                               received.
                                                       mus (DCPA).
5481-495........................  Non-guideline.....  Chronic Sediment    January 31, 2013..  January 31, 2013..  January 31, 2015..  No data received.
                                                       toxicity--Leptoch
                                                       eirus (DCPA).
5481-495........................  Non-guideline.....  Comparative         January 31, 2013..  January 31, 2013..  January 31, 2015..  No data received.
                                                       thyroid study
                                                       (DCPA).
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IV. How To Avoid Suspension Under this Notice?

    1. You may avoid suspension under this notice if you or another 
person adversely affected by this notice properly request a hearing 
within 30 days of your receipt of the Notice of Intent to Suspend or, 
if you did not receive the notice that was sent to you, then within 30 
days from the date of publication of this Federal Register notice (see 
DATES). If you request a hearing, it will be conducted in accordance 
with the requirements of FIFRA section 6(d) (7 U.S.C. 136d) and the 
Agency's procedural regulations in 40 CFR part 164, to the extent 
applicable. Section 3(c)(2)(B) of FIFRA (7 U.S.C. 136a), however, 
provides that the only allowable issues which may be addressed at the 
hearing are whether you have failed to take the actions which are the 
bases of this notice and whether the Agency's decision regarding the 
disposition of existing stocks is consistent with FIFRA. Therefore, no 
substantive allegation or legal argument concerning other issues, 
including but not limited to the Agency's original decision to require 
the submission of data or other information, the need for or utility of 
any of the required data or other information or deadlines imposed, any 
allegations of errors or unfairness in any proceedings before an 
arbitrator, and the risks and benefits associated with continued 
registration of the affected product, may be considered in the 
proceeding. The Administrative Law Judge shall by order dismiss any 
objections which have no bearing on the allowable issues which may be 
considered in the proceeding. Section 3(c)(2)(B)(iv) of FIFRA provides 
that any hearing must be held, and a determination issued within 75 
days after receipt of a hearing request. This 75-day period may not be 
extended unless all parties in the proceeding stipulate to such an 
extension. If a hearing is properly requested, the Agency will issue a 
final order at the conclusion of the hearing governing the suspension 
of your product. A request for a hearing pursuant to this notice must:
     Include specific objections which pertain to the allowable 
issues which may be heard at the hearing.
     Identify the registrations for which a hearing is 
requested.

[[Page 25265]]

     Set forth all necessary supporting facts pertaining to any 
of the objections which you have identified in your request for a 
hearing.
    If a hearing is requested by any person other than the registrant, 
that person must also state specifically why he/she asserts that he/she 
would be adversely affected by the suspension action described in this 
notice. Instructions for filing a request for a hearing are available 
at www.epa.gov/alj. You may file your request for a hearing 
electronically by clicking on the link to ``E-file using the electronic 
filing system,'' or choose an alternative filing option by clicking on 
the link to ``File by courier, mail or personal delivery.'' If you 
intend to use the electronic filing system, EPA advises that you 
register in advance because there may be a 1-2 business day delay 
between when you register and when you will be able to upload documents 
into the system.
    An additional copy should be sent to the person who signed this 
notice. The request must be received by the Hearing Clerk by the 
applicable 30th day deadline as measured from your receipt of the 
Notice of Intent to Suspend or publication of this notice, as set forth 
in DATES and in Unit IV.1., in order to be legally effective. The 30-
day time limit is established by FIFRA and cannot be extended for any 
reason. Failure to meet the 30-day time limit will result in automatic 
suspension of your registration by operation of law and, under such 
circumstances, the suspension of the registration for your affected 
product will be final and effective at the close of business on the 
applicable 30th day deadline as measured from your receipt of the 
Notice of Intent to Suspend or publication of this notice, as set forth 
in DATES and in Unit IV.1., and will not be subject to further 
administrative review. The Agency's rules of practice at 40 CFR 164.7 
forbid anyone who may take part in deciding this case, at any stage of 
the proceeding, from discussing the merits of the proceeding ex parte 
with any party or with any person who has been connected with the 
preparation or presentation of the proceeding as an advocate or in any 
investigative or expert capacity, or with any of their representatives. 
Accordingly, the following EPA offices, and the staffs thereof, are 
designated as judicial staff to perform the judicial function of EPA in 
any administrative hearings on this Notice of Intent to Suspend: The 
Office of the Administrative Law Judges, the Office of the 
Environmental Appeals Board, the EPA Administrator, the EPA Deputy 
Administrator, and the members of the staff in the immediate offices of 
the EPA Administrator and EPA Deputy Administrator. In addition, the 
Administrator may designate specific individuals in the immediate 
office of the Administrator and the Office of General Counsel as 
judicial staff for particular hearings. None of the persons designated 
as the judicial staff shall have any ex parte communication with trial 
staff or any other interested person not employed by EPA on the merits 
of any of the issues involved in this proceeding, without fully 
complying with the applicable regulations.
    2. You may also avoid suspension if, within the applicable 30-day 
deadline period as measured from your receipt of the Notice of Intent 
to Suspend or publication of this notice, as set forth in DATES and in 
Unit IV.1., the Agency determines that you have taken appropriate steps 
to comply with the FIFRA section 3(c)(2)(B) DCI notice. In order to 
avoid suspension under this option, you must satisfactorily comply with 
Table 2--List of Requirements in Unit III., for the product by 
submitting all required supporting data/information described in Table 
2 of Unit. III. and in the Explanatory Appendix (in the docket for this 
Federal Register notice) through CDX via the DCI application of the 
Pesticide Submission Portal (PSP). If you have a CDX account with 
access to the PSP, you may follow the link below to sign in, 
acknowledge receipt, and access your DCI(s): https://cdx.epa.gov/ gov/.
    A user guide is available for instructions on what to do if you do 
not have a CDX account or if you need to add PSP to your account: 
https://cdx.epa.gov/content/documents/PSP/OPP_CDX_Pesticide_Submission_PortalRegistration_UserGuidev1.0p.pdf.
    For you to avoid automatic suspension under this notice, the Agency 
must also determine within the applicable 30-day deadline period that 
you have satisfied the requirements that are the bases of this notice 
and so notify you in writing. You should submit the necessary data/
information as quickly as possible for there to be any chance the 
Agency will be able to make the necessary determination in time to 
avoid suspension of your product. The suspension of the registration of 
your company's product pursuant to this notice will be rescinded when 
the Agency determines you have complied fully with the requirements 
which were the bases of this notice. Such compliance may only be 
achieved by submission of the data/information described in Table 2 of 
Unit III.

V. Status of Products That Become Suspended

    Your product will remain suspended, however, until the Agency 
determines you are in compliance with the requirements which are the 
bases of this notice and so informs you in writing.
    After the suspension becomes final and effective, the registrant 
subject to this notice, including all supplemental registrants of 
product listed in Table 1 of Unit II., may not legally distribute, 
sell, use (including use to formulate another pesticide product), offer 
for sale, hold for sale, ship, deliver for shipment, or receive and 
(having so received) deliver or offer to deliver, to any person, the 
product listed in Table 1 of Unit II, except for the purpose of 
disposal in accordance with all applicable federal, state and local 
requirements. Any distribution or sale by the registrant subject to 
this notice, of a pesticide whose registration is suspended, is an 
unlawful act under section 12(a)(1)(A) of the FIFRA. Any other 
violation of the suspension order, including use to formulate another 
pesticide product, is an unlawful act under section 12(a)(2)(J) of 
FIFRA. Persons other than the registrant subject to this notice, as 
defined in the preceding sentence, may continue to distribute, sell, 
use, offer for sale, hold for sale, ship, deliver for shipment, or 
receive and (having so received) deliver or offer to deliver, to any 
person, the product listed in Table 1 of Unit II. Nothing in this 
notice authorizes any person to distribute, sell, use, offer for sale, 
hold for sale, ship, deliver for shipment, or receive and (having so 
received) deliver or offer to deliver, to any person, the product 
listed in Table 1 of Unit II. in any manner which would have been 
unlawful prior to the suspension.
    It is the responsibility of the basic registrant to notify all 
supplementary registered distributors of a basic registered product 
that this suspension action also applies to their supplementary 
registered products. The basic registrant may be held liable for 
violations committed by their distributors.
    Any questions about the requirements and procedures set forth in 
this notice or in the subject FIFRA section 3(c)(2)(B) DCI notice, 
should be addressed to the person listed under FOR FURTHER INFORMATION 
CONTACT.
    Authority: 7 U.S.C. 136 et seq.

[[Page 25266]]

    Dated: April 21, 2022.
Mary Elissa Reaves,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2022-09069 Filed 4-27-22; 8:45 am]
BILLING CODE 6560-50-P