Pesticides; Interim Process for Evaluating Potential Synergistic Effects of Pesticides During the Registration Process; Notice of Availability and Request for Comments, 47287-47288 [2019-19324]
Download as PDF
Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
Dated: September 3, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2019–19401 Filed 9–6–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
I. General Information
[EPA–HQ–OPP–2017–0433; FRL 9998–18]
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.
A. Does this action apply to me?
Pesticides; Interim Process for
Evaluating Potential Synergistic
Effects of Pesticides During the
Registration Process; Notice of
Availability and Request for Comments
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
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: https://
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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on comments
or visiting the docket, along with more
information about dockets generally, is
available at https://www.epa.gov/
dockets.
SUMMARY:
jbell on DSK3GLQ082PROD with NOTICES
(7507P), Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC
20460–0001; telephone number: (703)
305–6449; email address:
odenkirchen.edward@epa.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
Edward Odenkirchen, Environmental
Fate and Ecological Effects Division
VerDate Sep<11>2014
20:43 Sep 06, 2019
Jkt 247001
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
https://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.
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
47287
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
E:\FR\FM\09SEN1.SGM
09SEN1
47288
Federal Register / Vol. 84, No. 174 / Monday, September 9, 2019 / Notices
jbell on DSK3GLQ082PROD with NOTICES
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 ‘‘nonobvious’’ (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-assessingpesticide-risks/ecological-riskassessment-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
VerDate Sep<11>2014
20:43 Sep 06, 2019
Jkt 247001
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
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
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-andassessing-pesticide-risks/ecological-riskassessment-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]
BILLING CODE 6560–50–P
EXPORT-IMPORT BANK
[Document Number: 2019–6019]
Review of Proposed Guidelines for
Assessing Additionality Related to
Providing EXIM’s Support for Medium
and Long Term Export Transactions
The Export-Import Bank of the United
States (EXIM) is seeking comments on
proposed guidelines for determining
Additionality on requests the Bank
receives to support export transactions
with repayment amortizing over the
medium or long term. The proposed
guidelines can be viewed at: https://
www.exim.gov/Additionality.guidance.
Interested parties may submit comments
to additionality.review@exim.gov or by
mail to 811 Vermont Avenue NW, Room
E:\FR\FM\09SEN1.SGM
09SEN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on comments or visiting the docket, along
with more information about dockets generally, is available at https://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 https://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]
BILLING CODE 6560-50-P