[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47287-47288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19324]
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPP-2017-0433; FRL 9998-18]
Pesticides; Interim Process for Evaluating Potential Synergistic
Effects of Pesticides During the Registration Process; Notice of
Availability and Request for Comments
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: EPA is announcing the availability of and soliciting public
comment on an interim process it developed to address risk estimate
uncertainties associated with U.S. patent assertions of greater than
additive effects (GTA effects) in mixtures of pesticide active
ingredients for controlling pests (often referred to as ``synergy'').
EPA developed a process to document, review and, if necessary, revise
ecological risk estimates; and invites public comment on this process
to obtain and analyze GTA effects data identified in patent assertions.
DATES: Comments must be received on or before October 24, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number, EPA-HQ-OPP-2017-0433, 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.
Additional instructions on comments or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Edward Odenkirchen, Environmental Fate
and Ecological Effects Division (7507P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; telephone number: (703) 305-6449; 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, farm
worker, and agricultural advocates; the chemical industry; pesticide
users; and members of the public interested in the sale, distribution,
or use of pesticides and/or the potential impacts of pesticide use on
listed species and designated critical habitat. Given the broad
interest, the Agency has not attempted to identify or describe all the
specific entities that may be affected by this action.
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 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.
II. Background
EPA regulates pesticides under the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq., which governs the
production, use, distribution, and sale of pesticides. Under FIFRA,
pesticides distributed or sold in the United States must first be
registered with EPA unless they qualify for an exemption. A cornerstone
of the pesticide registration process is the data requirements that
applicants must fulfill regarding the pesticide's effects on human
health, the environment, and in some cases, its efficacy in controlling
pests.
The burden of demonstrating that a product meets the standards for
registration rests on the registrant or applicant for registration. To
obtain registration, applicants are responsible for citing or
generating all data necessary to meet data requirements specified by
EPA's regulations at 40 CFR part 158. An ecological risk assessment is
one key assessment EPA performs to determine what risks are posed by a
pesticide and whether changes to the use or proposed use are necessary
to protect the environment. To inform such assessments, EPA requires a
range of data in specific categories including: Product chemistry,
environmental and mammalian toxicity, environmental fate, residue
chemistry, reentry exposure, and spray drift.
EPA's historical process for evaluating pesticide ecological risks
has relied on toxicity information from studies conducted with single
active ingredients based on the lack of information on pesticide
interactions and the expectation that they are rare. In 2013, the
National Research Council (NRC) (Ref. 1) stated that toxicological
interactions between pesticide active ingredients that produce GTA
effects are rare and suggested that the Agency consider pesticide
active ingredient interactions when the best available scientific
evidence supports the evaluation.
However, in a lawsuit challenging EPA's 2014 decision to register a
new pesticide product containing two herbicide active ingredients
(Enlist Duo Herbicide) (Ref. 2), the plaintiffs presented evidence--
previously unknown to EPA--that the U.S. Patent and Trademark Office
(USPTO) had granted a patent for claims that Enlist Duo produced GTA
effects towards pest species. EPA subsequently discovered that a number
of other registrants were making similar claims of GTA effects towards
pest species before the USPTO, but were not disclosing these GTA claims
to EPA. Based on the new information regarding the potential
synergistic effects on non-target organisms when the two pesticide
active ingredients of Enlist Duo Herbicide are applied together, EPA
asked the court to remand the Enlist Duo Herbicide registration
decision to EPA for consideration of its potential for synergistic
effects (Ref. 3). Subsequently, in 2016, and 2017, EPA received
petitions asking it to require registrants to provide information on
potential synergy for consideration in EPA's ecological risk
assessments. In addition, subsequent public comments submitted
regarding pesticide regulatory
[[Page 47288]]
decisions continue to include this issue as a concern.
III. Interim Process
The criteria for use of GTA data for patent applications are
different than for EPA's quantitative analyses of risk. While the USPTO
patent evaluation process uses a standard that the issued assertion
must be novel and ``non-obvious'' (https://www.uspto.gov/web/offices/pac/mpep/mpep-2100.pdf), for EPA's quantitative risk assessments, the
data must meet the same standards for use of other toxicological data.
To address risk estimate uncertainties associated with patent
assertions of GTA effects, EPA has developed an interim process to
obtain, analyze, and document patent claims of GTA effects in mixtures
of pesticide active ingredients. The purpose of the interim process is
to evaluate the utility of collecting and reviewing GTA patent
information for use in conducting risk assessments, and to determine if
such data, where applicable, affect risk assessments. This process is
described in a document titled ``Process for Receiving and Evaluating
Data Supporting Assertions of Greater than Additive (GTA) Effects in
Mixtures of Pesticide Active Ingredients and Associated Guidance for
Registrants'' (Ref. 4) and summarized in this unit. The document is
available on the Agency's website: https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/ecological-risk-assessment-pesticides-technical and in the docket.
Generally, for new chemicals (specifically new conventional
pesticide active ingredients) and other new products or other active
ingredients for which EPA has specific concerns about the potential for
GTA effects, as part of the registration process, EPA will request
registrants to provide GTA effect information on approved patents and
conduct appropriate statistical analysis of that information using the
following steps:
Step 1: Search for and identify granted U.S. patents with
applications that made any claims of GTA effects;
Step 2: Conduct a review of patent data for relevance to ecological
risk assessment;
Steps 3, Report effects testing data from relevant patents; and
Step 4: Perform a statistical analysis using an EPA-establish
method to evaluate if observations of GTA effects are statistically
significant.
Step 5 is an Agency review of the submitted information from Steps
1-4.
Consistent with EPA's review of any scientific data submitted for
inclusion in the regulatory process, EPA will review submitted patent
searches and relevancy reporting in submissions to ensure that the
process is consistent with the Agency interpretation of patent
reporting and relevancy review.
EPA has generally been applying this interim process since 2016.
EPA's experience with the application of this interim process to date
suggests that patent submissions with relevant information that
demonstrate a sufficiently large, statistically significant GTA
interaction requiring quantitative consideration in ecological risk
assessments will likely be rare. More specifically, for the 24 new
active ingredient registrations that submitted patent data to date,
three contained pertinent information that indicated a need for further
testing and none ultimately led to adjustment in the risk assessment.
EPA plans to re-evaluate this interim process considering public
comment and after it has collected and analyzed more GTA patent
information submitted during registrations. Ultimately, EPA plans to
look at the results of this process to inform its determination as to
whether patent data has utility in EPA's risk assessments. If the
interim process demonstrates it does, then EPA plans to continue to
request or require registrants provide patent data and follow this
process (or an improved process reflecting comments and/or lessons
learned). If the process demonstrates that the patent data does not
have utility in EPA's risk assessments, EPA plans to communicate that
to the public and discontinue this process.
IV. Public Comments Sought
EPA is seeking comment on the interim process for assessing
potential GTA effects of pesticides during the registration process.
Specifically, EPA solicits comments on the following:
Are there technical aspects of the interim process that
warrant change? If so, what changes are recommended?
What aspects of the process could be applied to the
evaluation of open literature sources of GTA effects pesticide
interactions?
Should EPA consider standardizing a more detailed search
and reporting approach, and how should EPA do that?
Should EPA continue the evaluation process as described in
this document? If so, what performance metrics (e.g., number of
evaluations) should EPA consider before deciding the utility of this
approach?
What applicant burden is associated with the activities
described in this memorandum, including compiling, analyzing, and
submitting the information? Specifically, does an estimate of 80--240
hours of burden per applicant cover the respondent burden associated
with the interim process?
V. References
The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the person
listed under FOR FURTHER INFORMATION CONTACT.
1. National Research Council (NRC) 2013. Assessing Risks to
Endangered and Threatened Species from Pesticides. The National
Academies Press, Washington DC.
2. Case Nos. 14-73353, 14-73359, 15-71207, 15-71213 United States
Court of Appeals for the Ninth Circuit ID: 9731620, DktEntry: 56-1,
Page 1 of 215.
3. Case Nos. 14-73353, 14-73359, 15-71207, 15-71213 United States
Court of Appeals for the Ninth Circuit ID: 9770038, DktEntry: 121-1,
Page 1 of 12.
4. U.S EPA. Process for Receiving and Evaluation Data Supporting
Assertion of Greater than Additive (GTA) Effects in Mixtures of
Pesticide Active Ingredients and Associated Guidance for
Registrants, August 2019. It is available at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/ecological-risk-assessment-pesticides-technical.
Authority: 7 U.S.C. 136 et seq.
Dated: September 3, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator.
[FR Doc. 2019-19324 Filed 9-6-19; 8:45 am]
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