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

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Published

April 28, 2022

Issuing agencies

Environmental Protection Agency

Abstract

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 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.

Full Text

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<title>Federal Register, Volume 87 Issue 82 (Thursday, April 28, 2022)</title>
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[Federal Register Volume 87, Number 82 (Thursday, April 28, 2022)]
[Notices]
[Pages 25262-25266]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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:
<a href="/cdn-cgi/l/email-protection#eb8f849e8c878a9898c5818a868e98ab8e9b8ac58c849d"><span class="__cf_email__" data-cfemail="bbdfd4cedcd7dac8c895d1dad6dec8fbdecbda95dcd4cd">[email&#160;protected]</span></a>.

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 <a href="http://www.regulations.gov">http://www.regulations.gov</a> 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 <a href="/cdn-cgi/l/email-protection#6d09020e060819400e181e190200081f1e081f1b040e082d081d0c430a021b"><span class="__cf_email__" data-cfemail="62060d010907164f011711160d0f0710110710140b0107220712034c050d14">[email&#160;protected]</span></a> to arrange
material requests and appointments. Please review the visitor
instructions and additional information available at <a href="https://www.epa.gov/dockets/epa-docket-center-and-reading-room-open-public-appointment-only">https://www.epa.gov/dockets/epa-docket-center-and-reading-room-open-public-appointment-only</a>.
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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.

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
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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 <a href="https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0009">https://www.regulations.gov/document/EPA-HQ-OPP-2011-0374-0009</a>), 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
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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:
<bullet> Include specific objections which pertain to the allowable
issues which may be heard at the hearing.
<bullet> Identify the registrations for which a hearing is
requested.

[[Page 25265]]

<bullet> 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 <a href="http://www.epa.gov/alj">www.epa.gov/alj</a>. 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): <a href="https://cdx.epa.gov/">https://cdx.epa.gov/</a> 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:
<a href="https://cdx.epa.gov/content/documents/PSP/OPP_CDX_Pesticide_Submission_PortalRegistration_UserGuidev1.0p.pdf">https://cdx.epa.gov/content/documents/PSP/OPP_CDX_Pesticide_Submission_PortalRegistration_UserGuidev1.0p.pdf</a>.
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

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