[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: 
odenkirchen.edward@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, 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]
 BILLING CODE 6560-50-P


