Document ID: EPA-HQ-OPP-2008-0316-0058
Agency: epa
Document Type: Notice
Title: Registration Reviews: Draft Human Health and/or Ecological Risk Assessment(s), and Final Tetrachlorvinphos Occupational and Residential Exposure Risk Assessment, and decision to rely on data from human health research
Posted Date: 2017-05-25T04:00Z

[Federal Register Volume 82, Number 100 (Thursday, May 25, 2017)]
[Notices]
[Pages 24117-24119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10754]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2015-0794; FRL-9957-98]

Registration Review; Draft Human Health and/or Ecological Risk 
Assessment(s), and Final Tetrachlorvinphos Occupational and Residential 
Exposure Risk Assessment, and the Agency's Decision To Rely on Data 
From Human Health Research; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's draft human 
health and ecological risk assessments for the registration review of 
bromacil, cyprodinil, and propamocarb; the draft human health risk 
assessment for the registration review of cyphenothrin; and the draft 
ecological risk assessment for the registration review of 2, 4-D, and 
opens a public comment period on these documents. This notice also 
announces the availability of EPA's final occupational and residential 
exposure assessment for the registration review of tetrachlorvinphos 
(TCVP) and EPA's explanation for relying on TCVP data from human 
research on TCVP exposure from pet collars. The TCVP draft risk 
assessments were published for a 60-day public comment period in the 
Federal Register of January 20, 2016 (81 FR 3128) (FRL-9940-81). 
Registration review is EPA's periodic review of pesticide registrations 
to ensure that each pesticide continues to satisfy the statutory 
standard for registration; that is, the pesticide can perform its 
intended function without unreasonable adverse effects on human health 
or the environment. As part of the registration review process, the 
Agency has completed comprehensive draft human health and draft 
ecological risk assessments for the registration review of bromacil, 
cyprodinil, and propamocarb; the draft human health risk assessment for 
the registration review of cyphenothrin; the final occupational and 
residential exposure assessment for TCVP; and the draft ecological risk 
assessment for the registration review of 2, 4-D. After reviewing 
comments received during the public comment period for all pesticide 
cases named above (excluding TCVP), EPA may issue a revised risk 
assessment, explain any changes to the draft risk assessment, and 
respond to comments and may request public input on risk mitigation 
before completing a proposed registration review decision for the 
pesticides identified above. Regarding TCVP, the EPA has published a 
revised human health and final occupational and residential exposure 
assessment in addition to response to comments and other support 
documents, which explain changes to the preliminary risk assessments 
and responds to substantive comments. Through the registration review 
program, the EPA is ensuring that each pesticide's registrations are 
based on current scientific and other knowledge, including its effects 
on human health and the environment.

DATES: Comments must be received on or before July 24, 2017.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2015-0794, by one of the following methods:
     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), (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.html.

[[Page 24118]]

    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For pesticide specific information contact: The Chemical Review 
Manager for the pesticide of interest identified in Tables 1 and II of 
Unit III.
    For general questions on the registration review program, contact: 
Richard Dumas, Pesticide Re-Evaluation Division (7508P), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave. NW., Washington, DC 20460-0001; telephone number: (703) 308-8015; 
email address: dumas.richard@epa.gov.

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. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult the Chemical Review Manager identified in Tables 1 and II of 
Unit III.

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 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 preparing and submitting 
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
    3. Environmental justice. EPA seeks to achieve environmental 
justice, the fair treatment and meaningful involvement of any group, 
including minority and/or low income populations, in the development, 
implementation, and enforcement of environmental laws, regulations, and 
policies. To help address potential environmental justice issues, the 
Agency seeks information on any groups or segments of the population 
who, as a result of their location, cultural practices, or other 
factors, may have atypical or disproportionately high and adverse human 
health impacts or environmental effects from exposure to the pesticides 
discussed in this document, compared to the general population.

II. Authority

    EPA is conducting its registration review of the chemicals listed 
in Tables 1 and II of Unit III pursuant to section 3(g) of the FIFRA 
and the Procedural Regulations for Registration Review at 40 CFR part 
155, subpart C. Section 3(g) of FIFRA provides, among other things, 
that the registrations of pesticides are to be reviewed every 15 years. 
Under FIFRA, a pesticide product may be registered or remain registered 
only if it meets the statutory standard for registration given in FIFRA 
section 3(c)(5) (7 U.S.C. 136a(c)(5)). When used in accordance with 
widespread and commonly recognized practice, the pesticide product must 
perform its intended function without unreasonable adverse effects on 
the environment; that is, without any unreasonable risk to man or the 
environment, or a human dietary risk from residues that result from the 
use of a pesticide in or on food.

III. Registration Reviews

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide 
registration for the pesticides listed in Tables 1 and 2 to ensure that 
they continue to satisfy the FIFRA standard for registration--that is, 
that these chemicals can still be used without unreasonable adverse 
effects on human health or the environment.

 Table 1--Draft Risk Assessments Being Made Available for Public Comment
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 Registration review case name                      Contact and contact
          and number             Docket ID number       information
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2,4-D 0073....................  EPA-HQ-OPP-2012-0  Brittany Pruitt,
                                 330.               pruitt.brittany@epa.gov (703) 347-0289.
Bromacil 0041.................  EPA-HQ-OPP-2012-0  Steven Snyderman,
                                 445.               snyderman.steven@epa.gov (703) 347-0249.
Cyphenothrin 7412.............  EPA-HQ-OPP-2009-0  Margaret Hathaway,
                                 842.               hathaway.margaret@epa.gov (703) 305-
                                                    5076.
Cyprodinil 7025...............  EPA-HQ-OPP-2011-1  Leigh Rimmer,
                                 008.               rimmer.leigh@epa.gov
                                                    (703) 347-0553.
Propamocarb 3124..............  EPA-HQ-OPP-2011-0  Christina Scheltema,
                                 662.               scheltema.christina@epa.gov (703) 308-
                                                    2201.
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  Table 2--Final Occupational and Residential Exposure Assessment Being
                Made Available (No Public Comment Period)
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 Registration review case name                      Contact and contact
          and number             Docket ID number       information
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Tetrachlorvinphos (TCVP) 0321.  EPA-HQ-OPP-2008-0  James Parker,
                                 316.               parker.james@epa.gov
                                                    (703) 306-0469.
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    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, 
through this notice of availability, for interested parties to provide 
comments and input concerning the Agency's draft human health and 
ecological risk assessments for the registration review of bromacil, 
cyprodinil, and propamocarb; the draft human health risk assessment for 
cyphenothrin; and the draft ecological risk assessment for the 
registration review of 2, 4-D. Such comments and input could address, 
among other things, the Agency's risk assessment methodologies and 
assumptions, as applied to a draft risk assessment. The Agency will 
consider all comments received during the public comment period and 
make changes, as appropriate, to a draft human health and/or ecological 
risk assessment. EPA

[[Page 24119]]

may then issue a revised risk assessment, explain any changes to the 
draft risk assessment, and respond to comments. In the Federal Register 
notice announcing the availability of the revised risk assessment, if 
the revised risk assessment indicates risks of concern, the Agency may 
provide a comment period for the public to submit suggestions for 
mitigating the risk identified in the revised risk assessment before 
developing a proposed registration review decision on the pesticides 
identified above.
    As directed by FIFRA section 3(g), EPA is also reviewing the 
pesticide registration for TCVP to ensure that it continues to satisfy 
the FIFRA standard for registration--that is, that TCVP can still be 
used without unreasonable adverse effects on human health or the 
environment. TCVP is an organophosphate (OP) insecticide used to 
control fleas, ticks, flies, lice, and insect larvae on livestock and 
domestic animals and their premises. TCVP is also applied as a 
perimeter treatment. TCVP is formulated into dusts, pet collars, 
emulsifiable concentrates, feed additives (solid and liquid), feed 
blocks, wettable powders, pellets and granular products. This Federal 
Register notice is announcing that the EPA has published the final 
registration review TCVP occupational and residential exposure risk 
assessment for all TCVP uses.
    The final TCVP registration review occupational and residential 
exposure risk assessment incorporates several changes, including a 
reduction of the oral toxicological point of departure (POD) from 8.0 
milligram/kilogram/day (mg/kg/day) to 2.8 mg/kg/day; the use of human 
research data (Davis, M. et al.,) ``Assessing Intermittent Pesticide 
Exposure from Flea Control Collars Containing the Organophosphorus 
Insecticide Tetrachlorvinphos'' to assess residential post-application 
exposure; and an approach to account for the potential release of TCVP 
from pet collar products as a liquid and solid form concurrently.
    In addition to the final occupational and residential exposure 
assessment, the registration review docket for TCVP also includes other 
relevant documents related to the registration review of this case. The 
preliminary registration review assessments were previously posted to 
the published in the Federal Register of January 20, 2016 for a 60-day 
comment period, during which time the public was invited to submit 
comments or new information.
    During the 60-day comment period, comments were received from Bayer 
HealthCare (Bayer), The Hartz Mountain Corporation (Hartz), the Center 
for Biological Diversity (CBD), United States Department of Agriculture 
(USDA), Natural Resources Defense Council (NRDC) and the general 
public. The EPA's response to comments on the registration review 
preliminary risk assessments can be assessed in the TCVP docket (EPA-
HQ-OPP-2008-0316) at www.regulations.gov.
    In compliance with EPA's rule for protection of human subjects, 
specifically 40 CFR 26.1706(d), EPA is hereby publishing its full 
explanation of the Agency's decision to rely on data from human 
research ``Assessing Intermittent Pesticide Exposure From Flea Control 
Collars Containing the Organophosphorus Insecticide Tetrachlorvinphos 
(TCVP) by M. Keith Davis, J. Scott Boone, John E. Moran, John W. Tyler 
and Janice E. Chambers) on TCVP exposure from pet collars. Relying on 
this data is crucial to EPA's decision that more stringent regulatory 
restrictions are necessary to protect public health than could be 
justified without the data. EPA's full explanation can be found at 
regulations.gov in docket number EPA-HQ-OPP-2008-0316, and on OPP's Web 
page at https://www.epa.gov/ingredients-used-pesticide-products/use-tetrachlorvinfos-exposure-data-human-research.
    1. Other related information. Additional information on the 
registration review status of the chemicals listed in Tables 1 and 2 of 
Unit III, as well as information on the Agency's registration review 
program and on its implementing regulation is available at http://www.epa.gov/pesticide-reevaluation.
    2. Information submission requirements. Anyone may submit data or 
information in response to this document. To be considered during a 
pesticide's registration review, the submitted data or information must 
meet the following requirements:
     To ensure that EPA will consider data or information 
submitted, interested persons must submit the data or information 
during the comment period. The Agency may, at its discretion, consider 
data or information submitted at a later date.
     The data or information submitted must be presented in a 
legible and useable form. For example, an English translation must 
accompany any material that is not in English and a written transcript 
must accompany any information submitted as an audiographic or 
videographic record. Written material may be submitted in paper or 
electronic form.
     Submitters must clearly identify the source of any 
submitted data or information.
     Submitters may request the Agency to reconsider data or 
information that the Agency rejected in a previous review. However, 
submitters must explain why they believe the Agency should reconsider 
the data or information in the pesticide's registration review.
    As provided in 40 CFR 155.58, the registration review docket for 
each pesticide case will remain publicly accessible through the 
duration of the registration review process; that is, until all actions 
required in the final decision on the registration review case have 
been completed.

    Authority: 7 U.S.C. 136 et seq.

    Dated: January 13, 2017.
Yu-Ting Guilaran,
Director, Pesticide Re-Evaluation Division, Office of Pesticide 
Programs.
[FR Doc. 2017-10754 Filed 5-24-17; 8:45 am]
 BILLING CODE 6560-50-P