Pesticide Registration Review; Draft Human Health and/or Ecological Risk Assessments for Several Rodenticides; Notice of Availability

Cited as:85 FR 26456
Court:Environmental Protection Agency
Publication Date:04 May 2020
Record Number:2020-09455
Federal Register, Volume 85 Issue 86 (Monday, May 4, 2020)
[Federal Register Volume 85, Number 86 (Monday, May 4, 2020)]
                [Pages 26456-26457]
                From the Federal Register Online via the Government Publishing Office []
                [FR Doc No: 2020-09455]
                [EPA-HQ-OPP-2017-0720; FRL-10008-08]
                Pesticide Registration Review; Draft Human Health and/or
                Ecological Risk Assessments for Several Rodenticides; Notice of
                AGENCY: Environmental Protection Agency (EPA).
                ACTION: Notice.
                SUMMARY: This notice announces the availability of EPA's draft human
                health and/or ecological risk assessments for the registration review
                of brodifacoum, bromadiolone, bromethalin, cholecalciferol,
                chlorophacinone, difenacoum, difethialone, diphacinone and diphacinone
                sodium salt, and warfarin and warfarin sodium salt.
                DATES: Comments must be received on or before July 6, 2020.
                ADDRESSES: Submit your comments, to the docket identification (ID)
                number for the specific pesticide of interest provided in the Table in
                Unit IV, by one of the following methods:
                 Federal eRulemaking Portal:
                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
                 Hand Delivery: To make special arrangements for hand
                delivery or delivery of boxed information, please follow the
                instructions at
                 Additional instructions on commenting or visiting the docket, along
                with more information about dockets generally, are available at
                 For pesticide specific information contact: The Chemical Review
                Manager for the pesticide of interest identified in the Table in Unit
                 For general questions on the registration review program, contact:
                Melanie Biscoe, Pesticide Re-Evaluation Division (7508P), Office of
                Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
                Ave. NW, Washington, DC 20460-0001; telephone number: (703) 305-7106;
                email address: [email protected].
                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 the Table in Unit IV.
                B. What should I consider as I prepare my comments for EPA?
                 1. Submitting CBI. Do not submit this information to EPA through
       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
                 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. Background
                 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/or
                ecological risk assessments for all pesticides listed in the Table in
                Unit IV. After reviewing comments received during the public comment
                period, EPA may issue a revised risk assessment, explain any changes to
                the draft risk assessment, and
                [[Page 26457]]
                respond to comments and may request public input on risk mitigation
                before completing a proposed registration review decision for the
                pesticides listed in the Table in Unit IV. Through this program, EPA is
                ensuring that each pesticide's registration is based on current
                scientific and other knowledge, including its effects on human health
                and the environment.
                III. Authority
                 EPA is conducting its registration review of the chemicals listed
                in the Table in Unit IV pursuant to section 3(g) of the Federal
                Insecticide, Fungicide, and Rodenticide Act (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.
                IV. What action is the agency taking?
                 Pursuant to 40 CFR 155.58, this notice announces the availability
                of EPA's human health and/or ecological risk assessments for the
                pesticides shown in the following table and opens a 60-day public
                comment period on the risk assessments.
                 Table--Draft Risk Assessments Being Made Available for Public Comment
                 Chemical review
                 Registration review case name Docket ID No. manager and contact
                 and number information
                Brodifacoum, Case 2755........ EPA-HQ-OPP-2015-0 Kent Fothergill,
                 767. [email protected], 703-347-8299.
                Bromadiolone, Case 2760....... EPA-HQ-OPP-2015-0 Kent Fothergill,
                 768. [email protected], 703-347-8299.
                Bromethalin, Case 2765........ EPA-HQ-OPP-2016-0 Kent Fothergill,
                 077. [email protected], 703-347-8299.
                Cholecalciferol, Case 7600.... EPA-HQ-OPP-2016-0 Kent Fothergill,
                 139. [email protected], 703-347-8299.
                Chlorophacinone, Case 2100.... EPA-HQ-OPP-2015-0 Kent Fothergill,
                 778. [email protected], 703-347-8299.
                Difenacoum, Case 7630......... EPA-HQ-OPP-2015-0 Kent Fothergill,
                 769. [email protected], 703-347-8299.
                Difethialone, Case 7603....... EPA-HQ-OPP-2015-0 Kent Fothergill,
                 770. [email protected], 703-347-8299.
                Diphacinone and Diphacinone EPA-HQ-OPP-2015-0 Kent Fothergill,
                 Sodium Salt, Case 2205. 777. [email protected], 703-347-8299.
                Warfarin and Warfarin Sodium EPA-HQ-OPP-2015-0 Kent Fothergill,
                 Salt, Case 0011. 481. [email protected], 703-347-8299.
                 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/or
                ecological risk assessments for the pesticides listed in the Table in
                Unit IV. 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 may then issue a
                revised risk assessment, explain any changes to the draft risk
                assessment, and respond to comments.
                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: April 9, 2020.
                Mary Reaves,
                Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide
                [FR Doc. 2020-09455 Filed 5-1-20; 8:45 am]
                BILLING CODE 6560-50-P