80 FR 15598 - FIFRA Scientific Advisory Panel; Notice of Public Meeting
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 56 (March 24, 2015)
Federal Register Volume 80, Issue 56 (March 24, 2015)
| Page Range | 15598-15600 | |
| FR Document | 2015-06689 |
[Federal Register Volume 80, Number 56 (Tuesday, March 24, 2015)] [Notices] [Pages 15598-15600] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-06689] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2015-0130; FRL-9923-73] FIFRA Scientific Advisory Panel; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: There will be a 3-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review research to evaluate the potential for juvenile sensitivity to pyrethroids. DATES: The meeting will be held on May 19-21, 2015, from approximately 9:00 a.m. to 5:00 p.m. Comments. The Agency encourages written comments be submitted on or before May 5, 2015, and requests for oral comments be submitted on or before May 12, 2015. However, written comments and requests to make oral comments may be submitted until the date of the meeting, but anyone submitting written comments after May 5, 2015, should contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. For additional instructions, see Unit I.C. of the SUPPLEMENTARY INFORMATION. Nominations. Nominations of candidates to serve as ad hoc members of FIFRA SAP for this meeting should be provided on or before April 7, 2015. Webcast. This meeting may be webcast. Please refer to the FIFRA SAP Web site at http://www.epa.gov/scipoly/sap for information on how to access the webcast. Please note that the webcast is a supplementary public process provided only for convenience. If difficulties arise resulting in webcasting outages, the meeting will continue as planned. Special accommodations. For information on access or services for individuals with disabilities, and to request accommodation of a disability, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT at least 10 days prior to the meeting to give EPA as much time as possible to process your request. ADDRESSES: Meeting: The meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202. Comments. Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0130, 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 commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. Nominations, requests to present oral comments, and requests for special accommodations. Submit nominations to serve as ad hoc members of FIFRA SAP, requests for special accommodations, or requests to present oral comments to the DFO listed under FOR FURTHER INFORMATION CONTACT. FOR FURTHER INFORMATION CONTACT: Fred Jenkins, DFO, Office of Science [[Page 15599]] Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-3327; 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. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. Since other entities may also be interested, the Agency has not attempted to 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 CBI information to EPA through regulations.gov or email. If your comments contain any information that you consider to be CBI or otherwise protected, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting your comments. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. C. How may I participate in this meeting? You may participate in this meeting by following the instructions in this unit. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-OPP-2015-0130 in the subject line on the first page of your request. 1. Written comments. The Agency encourages written comments be submitted, using the instructions in ADDRESSES and Unit I.B., on or before May 5, 2015, to provide FIFRA SAP the time necessary to consider and review the written comments. Written comments are accepted until the date of the meeting, but anyone submitting written comments after May 5, 2015, should contact the DFO listed under FOR FURTHER INFORMATION CONTACT. Anyone submitting written comments at the meeting should bring 30 copies for distribution to FIFRA SAP. 2. Oral comments. The Agency encourages each individual or group wishing to make brief oral comments to FIFRA SAP submit their request to the DFO listed under FOR FURTHER INFORMATION CONTACT on or before May 12, 2015, in order to be included on the meeting agenda. Requests to present oral comments will be accepted until the date of the meeting and, to the extent that time permits, the Chair of FIFRA SAP may permit the presentation of oral comments at the meeting by interested persons who have not previously requested time. The request should identify the name of the individual making the presentation, the organization (if any) the individual will represent, and any requirements for audiovisual equipment. Oral comments given before the FIFRA SAP are limited to approximately 5 minutes unless prior arrangements have been made. In addition, each speaker should bring 20 copies of his or her comments and presentation for distribution to FIFRA SAP at the meeting. 3. Seating at the meeting. Seating at the meeting will be open and on a first-come basis. 4. Request for nominations to serve as ad hoc members of FIFRA SAP for this meeting. As part of a broader process for developing a pool of candidates for each meeting, FIFRA SAP staff routinely solicits the stakeholder community for nominations of prospective candidates for service as ad hoc members of FIFRA SAP. Any interested person or organization may nominate qualified individuals to be considered as prospective candidates for a specific meeting. Individuals nominated for this meeting should have expertise in one or more of the following areas: In vitro to in vivo extrapolation (IVIVE), Risk assessment, Toxicokinetics, Quantitative modeling and analyses of complex data, Pyrethroid pesticides, Age-dependent pharmacokinetics and metabolism, Enzyme maturation profiles in rodents and humans, Voltage-gated sodium channels, Ontogeny of metabolizing enzymes (e.g., carboxylesterase and P450), Clinical observations of neurotoxicology in animals (adult and neonate). Nominees should be scientists who have sufficient professional qualifications, including training and experience, to be capable of providing expert comments on the scientific issues for this meeting. Nominees should be identified by name, occupation, position, address, email address, and telephone number. Nominations should be provided to the DFO listed under FOR FURTHER INFORMATION CONTACT on or before April 7, 2015. The Agency will consider all nominations of prospective candidates for this meeting that are received on or before that date. However, final selection of ad hoc members for this meeting is a discretionary function of the Agency. The selection of scientists to serve on FIFRA SAP is based on the function of the Panel and the expertise needed to address the Agency's charge to the Panel. No interested scientists shall be ineligible to serve by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency, except EPA. Other factors considered during the selection process include availability of the potential Panel member to fully participate in the Panel's reviews, absence of any conflicts of interest or appearance of lack of impartiality, independence with respect to the matters under review, and lack of bias. Although financial conflicts of interest, the appearance of lack of impartiality, lack of independence, and bias may result in disqualification, the absence of such concerns does not assure that a candidate will be selected to serve on FIFRA SAP. Numerous qualified candidates are identified for each Panel. Therefore, selection decisions involve carefully weighing a number of factors including the candidates' areas of expertise and professional qualifications and achieving an overall balance of different scientific perspectives on the Panel. In order to have the collective breadth of experience needed to address the Agency's charge for this meeting, the Agency anticipates selecting approximately 10 ad hoc scientists. FIFRA SAP members are subject to the provisions of 5 CFR part 2634- Executive Branch Financial Disclosure, Qualified Trusts, and Certificates of Divestiture, as supplemented by EPA in 5 CFR part 6401. In anticipation of this requirement, prospective candidates for service on FIFRA SAP will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate's employment, stocks, and bonds, and where applicable, sources of research support. EPA will evaluate the candidates financial disclosure form to assess whether there are financial conflicts of interest, appearance of a lack of impartiality, or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on FIFRA SAP. Those who are selected from the pool of prospective candidates will be asked to attend the public meetings and to participate in the discussion of key issues and assumptions at these meetings. In addition, they will be asked [[Page 15600]] to review and to help finalize the meeting minutes. The list of FIFRA SAP members participating at this meeting will be posted on the FIFRA SAP Web site at http://www.epa.gov/scipoly/sap or may be obtained from the OPP Docket at http://www.regulations.gov. II. Background A. Purpose of FIFRA SAP FIFRA SAP serves as the primary scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide- related issues as to the impact of regulatory actions on health and the environment. FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act (5 U.S.C. Appendix). FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. FIFRA established a Science Review Board (SRB) consisting of at least 60 scientists who are available to FIFRA SAP on an ad hoc basis to assist in reviews conducted by FIFRA SAP. As a scientific peer review mechanism, FIFRA SAP provides comments, evaluations, and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency. B. Public Meeting The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizes EPA to register pesticides and the FFDCA gives the agency the authority to establish tolerances for residues resulting on food and/or feed resulting from use of a pesticide. The studies required to allow the agency to make the appropriate statutory safety findings under both of these acts are stipulated under 40 CFR part 158. There is flexibility, however, in implementing Part 158. Additional data can be required (Sec. 158.75), alternative approaches can be accepted, and studies can be waived (Sec. 158.45). The 2007 National Research Council (NRC) report from the National Academy of Sciences (NAS) on Toxicity Testing in the 21st Century describes this new vision for toxicity testing. In response to the NRC report, EPA's Office of Pesticide Programs (OPP) developed a Strategic Direction for New Pesticide Testing and Assessment Approaches http://www.epa.gov/pesticides/science/testing-assessment.html which describes OPP's approach to implementing the NAS vision. One of the key components of OPP's Strategic Direction is improved approaches to more traditional toxicity tests to minimize the number of animals used while expanding the amount of information obtained. OPP also has a recent document, Guiding Principles for Data Requirements (http://www.epa.gov/pesticides/regulating/data-require-guide-principle.pdf) which describes the principles for requiring toxicology data for pesticides, specifically to ``only require data that adequately inform regulatory decision making and thereby avoid unnecessary use of time and resources, data generation costs, and animal testing.'' OPP is actively working on a reevaluation of the human health effects of the pyrethroids and pyrethrins under the OPP registration review program (http://www.epa.gov/oppsrrd1/registration_review/index.htm), required under FIFRA. Until late 2009, OPP requested developmental neurotoxicity (DNT) studies for pyrethroids. However, the agency determined that the DNT studies were not providing adequate data to evaluate the potential for post-natal sensitivity to pyrethroids. In July, 2010, the FIFRA Scientific Advisory Panel (SAP) reviewed a proposed research strategy to assess the potential for juvenile sensitivity consistent with the recommendations of the NAS in its report on Toxicity Testing in the 21st Century using a combination of in vitro studies, targeted in vivo studies, and physiologically-based pharmacokinetic (PBPK) models. Based on feedback from the SAP and the agency, the industry research proposal was revised. Since late 2010, the Council for the Advancement of Pyrethroid Human Health Risk Assessment (CAPHRA) has worked with industry and academic scientists to develop assays and models to assess the potential for juvenile post-natal sensitivity to pyrethroids. The on-going research effort is organized around the adverse outcome pathway (AOP) for pyrethroids: Alterations with voltage-gated sodium channels (VGSC), leading to alterations in membrane excitability and firing potentials and ultimately to in vivo clinical syndromes. Specifically, the CAPHRA is evaluating the potency of pyrethroids to human sodium channels and transplantation of adult and juvenile rat synaptic membrane into oocytes. In addition, the CAPHRA is conducting targeted in vivo studies on behavioral metrics and developing PBPK models. The research, thus far, has focused on development of the overall approach using data for deltamethrin and permethrin (Type II and Type I pyrethroids, respectively). The CAPHRA research is at a point where feedback on extending this research to the other pyrethroids would be constructive. The CAPHRA proposal is to use the knowledge gained with deltamethrin and permethrin to develop more targeted datasets using read across and computational approaches (i.e., less data generation) for other pyrethroids. As such, the agency will be seeking the SAP's advice on the current state of the science with the CAPHRA research effort and proposals for next steps which include extension of data on deltamethrin and permethrin to other pyrethroids. C. FIFRA SAP Documents and Meeting Minutes EPA's background paper, related supporting materials, charge/ questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc members for this meeting), and the meeting agenda will be available by approximately 4 weeks before the meeting. In addition, the Agency may provide additional background documents as the materials become available. You may obtain electronic copies of these documents, and certain other related documents that might be available at http://www.regulations.gov and the FIFRA SAP Web site at http://www.epa.gov/scipoly/sap. FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency approximately 90 days after the meeting. The meeting minutes will be posted on the FIFRA SAP Web site or may be obtained from the OPP Docket at http://www.regulations.gov. Authority: 7 U.S.C. 136 et seq.; 21 U.S.C. 301 et seq. Dated: March 13, 2015. David J. Dix, Director, Office of Science Coordination and Policy. [FR Doc. 2015-06689 Filed 3-23-15; 8:45 am] BILLING CODE 6560-50-P
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Washington, DC 20460; telephone for information they submit in FURTHER INFORMATION CONTACT. For
number: 202–564–0628; fax number: accordance with 40 CFR 2.203. additional instructions, see Unit I.C. of
202–564–1177; email address: Forms: RFS Efficient Producer Data the SUPPLEMENTARY INFORMATION.
monger.jon@epa.gov. Form, RFS Cellulosic Biofuel Producer Nominations. Nominations of
Questionnaire Form. candidates to serve as ad hoc members
SUPPLEMENTARY INFORMATION: Respondents/affected entities: of FIFRA SAP for this meeting should
Supporting documents which explain in Producers, Importers of Renewable be provided on or before April 7, 2015.
detail the information that the EPA will Fuels. Webcast. This meeting may be
be collecting are available in the public Respondent’s obligation to respond: webcast. Please refer to the FIFRA SAP
docket for this ICR. The docket can be RFS Cellulosic Biofuel Producer Web site at http://www.epa.gov/scipoly/
viewed online at www.regulations.gov Questionnaire Form is voluntary; RFS sap for information on how to access the
or in person at the EPA Docket Center, Efficient Producer Data Form is webcast. Please note that the webcast is
WJC West, Room 3334, 1301 mandatory pursuant to Sections 114 and a supplementary public process
Constitution Ave. NW., Washington, 208 of the Clean Air Act (CAA), 42 provided only for convenience. If
DC. The telephone number for the U.S.C. 7414 and 7542. difficulties arise resulting in webcasting
Docket Center is 202–566–1744. For Estimated number of respondents: 80 outages, the meeting will continue as
additional information about EPA’s (total). planned.
public docket, visit http://www.epa.gov/ Frequency of response: Annually (RFS Special accommodations. For
dockets. Cellulosic Biofuel Producer information on access or services for
Pursuant to section 3506(c)(2)(A) of Questionnaire Form) or quarterly (RFS individuals with disabilities, and to
the PRA, EPA is soliciting comments Efficient Producer Data Form). request accommodation of a disability,
and information to enable it to: (i) Total estimated burden: 560 hours please contact the DFO listed under FOR
Evaluate whether the proposed (per year). Burden is defined at 5 CFR FURTHER INFORMATION CONTACT at least
collection of information is necessary 1320.03(b). 10 days prior to the meeting to give EPA
for the proper performance of the Total estimated cost: $63,840 (per as much time as possible to process
functions of the Agency, including year). your request.
whether the information will have Changes in estimates: There is no ADDRESSES: Meeting: The meeting will
practical utility; (ii) evaluate the previous ICR for this collection. be held at the Environmental Protection
accuracy of the Agency’s estimate of the Dated: March 17, 2015. Agency, Conference Center, Lobby
burden of the proposed collection of Karl Simon, Level, One Potomac Yard (South Bldg.),
information, including the validity of 2777 S. Crystal Dr., Arlington, VA
Director, Transportation and Climate
the methodology and assumptions used; Division, Office of Transportation and Air 22202.
(iii) enhance the quality, utility, and Quality. Comments. Submit your comments,
clarity of the information to be [FR Doc. 2015–06770 Filed 3–23–15; 8:45 am] identified by docket identification (ID)
collected; and (iv) minimize the burden number EPA–HQ–OPP–2015–0130, by
BILLING CODE 6560–50–P
of the collection of information on those one of the following methods:
who are to respond, including through • Federal eRulemaking Portal: http://
the use of appropriate automated ENVIRONMENTAL PROTECTION www.regulations.gov. Follow the online
electronic, mechanical, or other AGENCY instructions for submitting comments.
technological collection techniques or Do not submit electronically any
other forms of information technology, [EPA–HQ–OPP–2015–0130; FRL–9923–73] information you consider to be
e.g., permitting electronic submission of Confidential Business Information (CBI)
responses. EPA will consider the FIFRA Scientific Advisory Panel;
or other information whose disclosure is
comments received and amend the ICR Notice of Public Meeting
restricted by statute.
as appropriate. The final ICR package AGENCY: Environmental Protection • Mail: OPP Docket, Environmental
will then be submitted to OMB for Agency (EPA). Protection Agency Docket Center (EPA/
review and approval. At that time, EPA ACTION: Notice. DC), (28221T), 1200 Pennsylvania Ave.
will issue another Federal Register NW., Washington, DC 20460–0001.
notice to announce the submission of SUMMARY: There will be a 3–day meeting • Hand Delivery: To make special
the ICR to OMB and the opportunity to of the Federal Insecticide, Fungicide, arrangements for hand delivery or
submit additional comments to OMB. and Rodenticide Act Scientific Advisory delivery of boxed information, please
Abstract: EPA is seeking to collect Panel (FIFRA SAP) to consider and follow the instructions at http://
information from potential cellulosic review research to evaluate the potential www.epa.gov/dockets/contacts.html.
biofuel producers to aid in determining for juvenile sensitivity to pyrethroids. Additional instructions on commenting
the annual volume standards. This ICR DATES: The meeting will be held on May or visiting the docket, along with more
includes a questionnaire form to 19–21, 2015, from approximately 9:00 information about dockets generally, is
facilitate the collection of this a.m. to 5:00 p.m. available at
information. EPA would also like to use Comments. The Agency encourages http://www.epa.gov/dockets.
a data form to collect information from written comments be submitted on or Nominations, requests to present oral
certain ethanol producers and importers before May 5, 2015, and requests for oral comments, and requests for special
accommodations. Submit nominations
mstockstill on DSK4VPTVN1PROD with NOTICES
who have requested and been approved comments be submitted on or before
to use an ‘‘efficient producer’’ pathway. May 12, 2015. However, written to serve as ad hoc members of FIFRA
This data form would standardize comments and requests to make oral SAP, requests for special
collection of selected data points and comments may be submitted until the accommodations, or requests to present
allow better and more efficient date of the meeting, but anyone oral comments to the DFO listed under
compliance with the RFS program. We submitting written comments after May FOR FURTHER INFORMATION CONTACT.
inform respondents that they may assert 5, 2015, should contact the Designated FOR FURTHER INFORMATION CONTACT: Fred
claims of business confidentiality (CBI) Federal Official (DFO) listed under FOR Jenkins, DFO, Office of Science
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to review and to help finalize the toxicity testing. In response to the NRC and juvenile rat synaptic membrane into
meeting minutes. The list of FIFRA SAP report, EPA’s Office of Pesticide oocytes. In addition, the CAPHRA is
members participating at this meeting Programs (OPP) developed a Strategic conducting targeted in vivo studies on
will be posted on the FIFRA SAP Web Direction for New Pesticide Testing and behavioral metrics and developing
site at http://www.epa.gov/scipoly/sap Assessment Approaches http:// PBPK models. The research, thus far,
or may be obtained from the OPP Docket www.epa.gov/pesticides/science/testing- has focused on development of the
at http://www.regulations.gov. assessment.html which describes OPP’s overall approach using data for
approach to implementing the NAS deltamethrin and permethrin (Type II
II. Background vision. One of the key components of and Type I pyrethroids, respectively).
A. Purpose of FIFRA SAP OPP’s Strategic Direction is improved The CAPHRA research is at a point
approaches to more traditional toxicity
FIFRA SAP serves as the primary where feedback on extending this
tests to minimize the number of animals
scientific peer review mechanism of research to the other pyrethroids would
used while expanding the amount of
EPA’s Office of Chemical Safety and be constructive. The CAPHRA proposal
information obtained. OPP also has a
Pollution Prevention (OCSPP) and is is to use the knowledge gained with
recent document, Guiding Principles for
structured to provide scientific advice, deltamethrin and permethrin to develop
Data Requirements (http://
information and recommendations to more targeted datasets using read across
www.epa.gov/pesticides/regulating/
the EPA Administrator on pesticides and computational approaches (i.e., less
data-require-guide-principle.pdf) which
and pesticide-related issues as to the data generation) for other pyrethroids.
describes the principles for requiring
impact of regulatory actions on health As such, the agency will be seeking the
toxicology data for pesticides,
and the environment. FIFRA SAP is a specifically to ‘‘only require data that SAP’s advice on the current state of the
Federal advisory committee established adequately inform regulatory decision science with the CAPHRA research
in 1975 under FIFRA that operates in making and thereby avoid unnecessary effort and proposals for next steps
accordance with requirements of the use of time and resources, data which include extension of data on
Federal Advisory Committee Act (5 generation costs, and animal testing.’’
U.S.C. Appendix). FIFRA SAP is deltamethrin and permethrin to other
OPP is actively working on a pyrethroids.
composed of a permanent panel reevaluation of the human health effects
consisting of seven members who are of the pyrethroids and pyrethrins under C. FIFRA SAP Documents and Meeting
appointed by the EPA Administrator the OPP registration review program Minutes
from nominees provided by the National (http://www.epa.gov/oppsrrd1/
Institutes of Health and the National registration_review/index.htm), required EPA’s background paper, related
Science Foundation. FIFRA established under FIFRA. supporting materials, charge/questions
a Science Review Board (SRB) Until late 2009, OPP requested to FIFRA SAP, FIFRA SAP composition
consisting of at least 60 scientists who developmental neurotoxicity (DNT) (i.e., members and ad hoc members for
are available to FIFRA SAP on an ad hoc studies for pyrethroids. However, the this meeting), and the meeting agenda
basis to assist in reviews conducted by agency determined that the DNT studies will be available by approximately 4
FIFRA SAP. As a scientific peer review were not providing adequate data to weeks before the meeting. In addition,
mechanism, FIFRA SAP provides evaluate the potential for post-natal the Agency may provide additional
comments, evaluations, and sensitivity to pyrethroids. In July, 2010, background documents as the materials
recommendations to improve the the FIFRA Scientific Advisory Panel become available. You may obtain
effectiveness and quality of analyses (SAP) reviewed a proposed research electronic copies of these documents,
made by Agency scientists. Members of strategy to assess the potential for and certain other related documents that
FIFRA SAP are scientists who have juvenile sensitivity consistent with the might be available at http://
sufficient professional qualifications, recommendations of the NAS in its www.regulations.gov and the FIFRA
including training and experience, to report on Toxicity Testing in the 21st SAP Web site at http://www.epa.gov/
provide expert advice and Century using a combination of in vitro
recommendation to the Agency. scipoly/sap.
studies, targeted in vivo studies, and
physiologically-based pharmacokinetic FIFRA SAP will prepare meeting
B. Public Meeting minutes summarizing its
(PBPK) models.
The Federal Insecticide, Fungicide, Based on feedback from the SAP and recommendations to the Agency
and Rodenticide Act (FIFRA) authorizes the agency, the industry research approximately 90 days after the
EPA to register pesticides and the proposal was revised. Since late 2010, meeting. The meeting minutes will be
FFDCA gives the agency the authority to the Council for the Advancement of posted on the FIFRA SAP Web site or
establish tolerances for residues Pyrethroid Human Health Risk may be obtained from the OPP Docket
resulting on food and/or feed resulting Assessment (CAPHRA) has worked with at http://www.regulations.gov.
from use of a pesticide. The studies industry and academic scientists to
required to allow the agency to make the develop assays and models to assess the Authority: 7 U.S.C. 136 et seq.; 21 U.S.C.
appropriate statutory safety findings potential for juvenile post-natal 301 et seq.
under both of these acts are stipulated sensitivity to pyrethroids. The on-going Dated: March 13, 2015.
under 40 CFR part 158. There is research effort is organized around the David J. Dix,
flexibility, however, in implementing adverse outcome pathway (AOP) for Director, Office of Science Coordination and
mstockstill on DSK4VPTVN1PROD with NOTICES
Part 158. Additional data can be pyrethroids: Alterations with voltage- Policy.
required (§ 158.75), alternative gated sodium channels (VGSC), leading [FR Doc. 2015–06689 Filed 3–23–15; 8:45 am]
approaches can be accepted, and studies to alterations in membrane excitability
BILLING CODE 6560–50–P
can be waived (§ 158.45). The 2007 and firing potentials and ultimately to in
National Research Council (NRC) report vivo clinical syndromes. Specifically,
from the National Academy of Sciences the CAPHRA is evaluating the potency
(NAS) on Toxicity Testing in the 21st of pyrethroids to human sodium
Century describes this new vision for channels and transplantation of adult
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Document Created: 2015-12-18 11:45:26
Document Modified: 2015-12-18 11:45:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | The meeting will be held on May 19-21, 2015, from approximately 9:00 a.m. to 5:00 p.m. | |
| Contact | Fred Jenkins, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: | |
| FR Citation | 80 FR 15598 |
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