80 FR 45218 - Pesticide Cumulative Risk Assessment: Framework for Screening Analysis; Notice of Availability and Request for Comment
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 80, Issue 145 (July 29, 2015)
Federal Register Volume 80, Issue 145 (July 29, 2015)
| Page Range | 45218-45219 | |
| FR Document | 2015-18612 |
[Federal Register Volume 80, Number 145 (Wednesday, July 29, 2015)] [Notices] [Pages 45218-45219] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-18612] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OPP-2015-0422; FRL-9930-32] Pesticide Cumulative Risk Assessment: Framework for Screening Analysis; Notice of Availability and Request for Comment AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: EPA is announcing the availability of draft guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, for public comment. This document provides guidance on how the EPA will screen groups of pesticides for cumulative evaluation using a two-step approach beginning with the evaluation of available toxicological information and if necessary followed by a risk-based screening approach. This framework supplements the existing guidance documents for establishing common mechanism groups (CMGs) and conducting cumulative risk assessments (CRA). Additionally, EPA is also seeking comments on a draft copy of the human health risk assessment where the cumulative assessment was conducted in conjunction with pending actions for abamectin. DATES: Comments must be received on or before August 28, 2015. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0422 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. FOR FURTHER INFORMATION CONTACT: Monique Perron, Health Effects Division (7509P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- 0001; telephone number: (703) 347-0395; email address: [email protected] or Don Wilbur, Health Effects Division (7509P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (703) 347-8894; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: Crop production (NAICS code 111). Animal production (NAICS code 112). Food manufacturing (NAICS code 311). Pesticide manufacturing (NAICS code 32532). 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 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 http://www.epa.gov/dockets/comments.html. II. What action is the Agency taking? Section 408(b)(2)(D)(v) of the Federal Food, Drug, and Cosmetic Act (FFDCA) requires EPA to take into account available evidence concerning the cumulative effects of pesticide residues and other substances that have a common mechanism of toxicity. The Office of Pesticide Programs (OPP) has previously developed two guidance documents: Guidance For Identifying Pesticide Chemicals and Other Substances that have a Common Mechanism of Toxicity (USEPA, 1999), which describes the process for CMGs; Guidance on Cumulative Risk Assessment of Pesticide Chemicals That Have a Common Mechanism of Toxicity (USEPA, 2002), which describes the steps used in conducting CRA. Copies of those two guidance documents can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2015-0422. The process described in those documents results in a highly refined CRA but requires an extensive amount of resources, large amounts of toxicology and exposure data, and may involve sophisticated modelling. The process involves developing science policy documents that establish a CMG before conducting a highly refined CRA. To date, OPP has established five CMGs: Organophosphates (OPs), N-methyl carbamates (NMCs), chloracetanilides, triazines, and naturally occurring pyrethrins and synthetic pyrethroids. CRAs have been conducted on each group and are available at http://www.epa.gov/oppsrrd1/cumulative/. The level of refinement provided by this approach is not necessary or even feasible for all existing pesticide classes. The 2002 CRA guidance notes that not all cumulative assessments need to be of the same depth and scope and that it is important to determine the need for a comprehensive risk assessment by considering the exposure profile. The 2011 World Health Organization International Programme on Chemical Safety guidance on CRA which are available at http://www.who.int/ipcs/en [[Page 45219]] describes a screening approach involving tiered analysis with increasing levels of refinement. The Agency has developed this guidance to assist scientists and decision-makers in screening pesticides for potential common mechanism groupings and conducting screening-level CRAs, neither of which is provided for in either of the listed guidance documents. Specifically, the draft Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, that the EPA is seeking comment on, provides guidance for screening available information to identify groups of pesticides that may have a common mechanism of toxicity (i.e., candidate CMGs). In addition, this document provides guidance for screening available information on those candidate groups for potential cumulative risks, which may lead to more refined CRAs. This document relies on the policies and principles provided in the CMG and CRA guidance documents along with expertise and knowledge gained by OPP in the conduct of the five referenced CRAs. Based on the proposed screening guidance, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, EPA determined that abamectin and emamectin share a similar toxicological profile and a testable hypothesis can be identified. Thus, EPA has developed a screening level cumulative analysis using highly conservative exposure assumptions. Specifically, dietary and residential exposures were assessed to determine whether there would be any potential cumulative concern. The cumulative assessment was done in conjunction with pending actions for abamectin to expand the use of abamectin on Caneberry subgroup 13-07A, soybeans, sweet corn, ear tags for lactating dairy cattle, and golf course turf. A draft copy of the human health risk assessment considering both aggregate and cumulative risks is included in the docket to provide an example of how the EPA would implement the, Pesticide Cumulative Risk Assessment: Framework for Screening Analysis, and to allow for public comment. Authority: FFDCA Sec. 408(b) [21 U.S.C. 346 a(b)]. Dated: July 17, 2015. Jack Housenger, Director, Office of Pesticide Programs. [FR Doc. 2015-18612 Filed 7-28-15; 8:45 am] BILLING CODE 6560-50-P
![45218 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Notices
listing of 279 water body-pollutant or other information whose disclosure is includes information claimed as CBI, a
combinations and associated priority restricted by statute. copy of the comment that does not
rankings, and proposed to disapprove • Mail: OPP Docket, Environmental contain the information claimed as CBI
Louisiana’s decisions not to list 43 Protection Agency Docket Center (EPA/ must be submitted for inclusion in the
water quality limited segments and DC), (28221T), 1200 Pennsylvania Ave. public docket. Information so marked
associated pollutants constituting 93 NW., Washington, DC 20460–0001. will not be disclosed except in
waterbody-pollutant combinations. On • Hand Delivery: To make special accordance with procedures set forth in
July 21, 2015, EPA finalized the action arrangements for hand delivery or 40 CFR part 2.
to disapprove Louisiana’s 2014 listing delivery of boxed information, please 2. Tips for preparing your comments.
decisions not to list 43 water quality follow the instructions at http:// When preparing and submitting your
limited segments. EPA identified these www.epa.gov/dockets/contacts.html. comments, see the commenting tips at
additional waters for inclusion on the Additional instructions on http://www.epa.gov/dockets/
2014 Section 303(d) List. commenting or visiting the docket, comments.html.
along with more information about II. What action is the Agency taking?
Dated: July 21, 2015.
dockets generally, is available at
William K. Honker, Section 408(b)(2)(D)(v) of the Federal
http://www.epa.gov/dockets.
Director, Water Quality Protection Division, Food, Drug, and Cosmetic Act (FFDCA)
FOR FURTHER INFORMATION CONTACT:
Region 6. requires EPA to take into account
Monique Perron, Health Effects Division
[FR Doc. 2015–18523 Filed 7–28–15; 8:45 am]
(7509P), Office of Pesticide Programs, available evidence concerning the
BILLING CODE 6560–50–P
Environmental Protection Agency, 1200 cumulative effects of pesticide residues
Pennsylvania Ave. NW., Washington, and other substances that have a
common mechanism of toxicity. The
ENVIRONMENTAL PROTECTION DC 20460–0001; telephone number:
Office of Pesticide Programs (OPP) has
AGENCY (703) 347–0395; email address:
previously developed two guidance
perron.monique@epa.gov or Don
[EPA–HQ–OPP–2015–0422; FRL–9930–32] documents:
Wilbur, Health Effects Division (7509P), • Guidance For Identifying Pesticide
Office of Pesticide Programs, Chemicals and Other Substances that
Pesticide Cumulative Risk Environmental Protection Agency, 1200
Assessment: Framework for Screening have a Common Mechanism of Toxicity
Pennsylvania Ave. NW., Washington, (USEPA, 1999), which describes the
Analysis; Notice of Availability and DC 20460–0001; telephone number:
Request for Comment process for CMGs;
(703) 347–8894; email address: • Guidance on Cumulative Risk
AGENCY: Environmental Protection wilbur.donald@epa.gov. Assessment of Pesticide Chemicals That
Agency (EPA). SUPPLEMENTARY INFORMATION: Have a Common Mechanism of Toxicity
ACTION: Notice. I. General Information (USEPA, 2002), which describes the
steps used in conducting CRA. Copies of
SUMMARY: EPA is announcing the A. Does this action apply to me? those two guidance documents can be
availability of draft guidance, Pesticide found at http://www.regulations.gov in
You may be potentially affected by
Cumulative Risk Assessment: docket ID number EPA–HQ–OPP–2015–
this action if you are an agricultural
Framework for Screening Analysis, for 0422.
producer, food manufacturer, or
public comment. This document The process described in those
pesticide manufacturer. The following
provides guidance on how the EPA will documents results in a highly refined
list of North American Industrial
screen groups of pesticides for CRA but requires an extensive amount
Classification System (NAICS) codes is
cumulative evaluation using a two-step of resources, large amounts of
not intended to be exhaustive, but rather
approach beginning with the evaluation toxicology and exposure data, and may
provides a guide to help readers
of available toxicological information involve sophisticated modelling. The
determine whether this document
and if necessary followed by a risk- process involves developing science
applies to them. Potentially affected
based screening approach. This policy documents that establish a CMG
entities may include:
framework supplements the existing
• Crop production (NAICS code 111). before conducting a highly refined CRA.
guidance documents for establishing • Animal production (NAICS code To date, OPP has established five CMGs:
common mechanism groups (CMGs) and 112). Organophosphates (OPs), N-methyl
conducting cumulative risk assessments • Food manufacturing (NAICS code carbamates (NMCs), chloracetanilides,
(CRA). Additionally, EPA is also seeking 311). triazines, and naturally occurring
comments on a draft copy of the human • Pesticide manufacturing (NAICS pyrethrins and synthetic pyrethroids.
health risk assessment where the code 32532). CRAs have been conducted on each
cumulative assessment was conducted group and are available at http://
in conjunction with pending actions for B. What should I consider as I prepare www.epa.gov/oppsrrd1/cumulative/.
abamectin. my comments for EPA? The level of refinement provided by
DATES: Comments must be received on 1. Submitting CBI. Do not submit this this approach is not necessary or even
or before August 28, 2015. information to EPA through feasible for all existing pesticide classes.
ADDRESSES: Submit your comments, regulations.gov or email. Clearly mark The 2002 CRA guidance notes that not
identified by docket identification (ID) the part or all of the information that all cumulative assessments need to be of
number EPA–HQ–OPP–2015–0422 by you claim to be CBI. For CBI the same depth and scope and that it is
tkelley on DSK3SPTVN1PROD with NOTICES
one of the following methods: information in a disk or CD–ROM that important to determine the need for a
• Federal eRulemaking Portal: http:// you mail to EPA, mark the outside of the comprehensive risk assessment by
www.regulations.gov. Follow the online disk or CD–ROM as CBI and then considering the exposure profile. The
instructions for submitting comments. identify electronically within the disk or 2011 World Health Organization
Do not submit electronically any CD–ROM the specific information that International Programme on Chemical
information you consider to be is claimed as CBI. In addition to one Safety guidance on CRA which are
Confidential Business Information (CBI) complete version of the comment that available at http://www.who.int/ipcs/en
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![Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Notices 45219
describes a screening approach ENVIRONMENTAL PROTECTION who conduct or sponsor research on
involving tiered analysis with AGENCY pesticides, EPA has not attempted to
increasing levels of refinement. The describe all the specific entities that
[EPA–HQ–OPP–2015–0374; FRL–9930–74]
Agency has developed this guidance to may be affected by this action.
assist scientists and decision-makers in Pesticide Experimental Use Permit; B. What should I consider as I prepare
screening pesticides for potential Receipt of Application; Comment my comments for EPA?
common mechanism groupings and Request
conducting screening-level CRAs, 1. Submitting CBI. Do not submit this
neither of which is provided for in AGENCY: Environmental Protection information to EPA through
either of the listed guidance documents. Agency (EPA). regulations.gov or email. Clearly mark
ACTION: Notice. the part or all of the information that
Specifically, the draft Pesticide
you claim to be CBI. For CBI
Cumulative Risk Assessment: SUMMARY: This notice announces EPA’s information in a disk or CD–ROM that
Framework for Screening Analysis, that receipt of an application (88877–EUP–E) you mail to EPA, mark the outside of the
the EPA is seeking comment on, from the University of Kentucky’s disk or CD–ROM as CBI and then
provides guidance for screening Department of Entomology requesting identify electronically within the disk or
available information to identify groups an experimental use permit (EUP) for CD–ROM the specific information that
of pesticides that may have a common Wolbachia pipientis, wAlbB Strain. EPA is claimed as CBI. In addition to one
mechanism of toxicity (i.e., candidate has determined that the permit may be complete version of the comment that
CMGs). In addition, this document of regional and national significance. includes information claimed as CBI, a
provides guidance for screening Therefore, because of the potential copy of the comment that does not
available information on those significance, EPA is seeking comments contain the information claimed as CBI
candidate groups for potential on this application. must be submitted for inclusion in the
cumulative risks, which may lead to DATES: Comments must be received on public docket. Information so marked
more refined CRAs. This document or before August 28, 2015. will not be disclosed except in
relies on the policies and principles ADDRESSES: Submit your comments, accordance with procedures set forth in
provided in the CMG and CRA guidance identified by docket identification (ID) 40 CFR part 2.
documents along with expertise and number EPA–HQ–OPP–2015–0374, by 2. Tips for preparing your comments.
knowledge gained by OPP in the one of the following methods: When preparing and submitting your
conduct of the five referenced CRAs. • Federal eRulemaking Portal: http:// comments, see the commenting tips at
Based on the proposed screening www.regulations.gov. Follow the online http://www.epa.gov/dockets/
guidance, Pesticide Cumulative Risk instructions for submitting comments. comments.html.
Assessment: Framework for Screening Do not submit electronically any 3. Environmental justice. EPA seeks to
Analysis, EPA determined that information you consider to be achieve environmental justice, the fair
abamectin and emamectin share a Confidential Business Information (CBI) treatment and meaningful involvement
similar toxicological profile and a or other information whose disclosure is of any group, including minority and/or
testable hypothesis can be identified. restricted by statute. low income populations, in the
Thus, EPA has developed a screening • Mail: OPP Docket, Environmental development, implementation, and
level cumulative analysis using highly Protection Agency Docket Center (EPA/ enforcement of environmental laws,
conservative exposure assumptions. DC), (28221T), 1200 Pennsylvania Ave. regulations, and policies. To help
Specifically, dietary and residential NW., Washington, DC 20460–0001. address potential environmental justice
exposures were assessed to determine • Hand Delivery: To make special issues, EPA seeks information on any
whether there would be any potential arrangements for hand delivery or groups or segments of the population
cumulative concern. delivery of boxed information, please who, as a result of their location,
follow the instructions at http:// cultural practices, or other factors, may
The cumulative assessment was done
www.epa.gov/dockets/contacts.html. have atypical or disproportionately high
in conjunction with pending actions for
Additional instructions on commenting and adverse human health impacts or
abamectin to expand the use of environmental effects from exposure to
or visiting the docket, along with more
abamectin on Caneberry subgroup 13– the pesticide discussed in this
information about dockets generally, is
07A, soybeans, sweet corn, ear tags for document, compared to the general
available at http://www.epa.gov/
lactating dairy cattle, and golf course population.
dockets.
turf. A draft copy of the human health
risk assessment considering both FOR FURTHER INFORMATION CONTACT: II. What action is EPA taking?
aggregate and cumulative risks is Robert McNally, Director, Biopesticides
Under section 5 of the Federal
included in the docket to provide an and Pollution Prevention Division
Insecticide, Fungicide, and Rodenticide
example of how the EPA would (7511P), Office of Pesticide Programs,
Act (FIFRA), 7 U.S.C. 136c, EPA can
implement the, Pesticide Cumulative Environmental Protection Agency, 1200
allow manufacturers to field test
Risk Assessment: Framework for Pennsylvania Ave. NW., Washington,
pesticides under development.
Screening Analysis, and to allow for DC 20460–0001; main telephone
Manufacturers are required to obtain an
public comment. number: (703) 305–7090; email address:
EUP before testing new pesticides or
BPPDFRNotices@epa.gov.
Authority: FFDCA § 408(b) [21 U.S.C. 346 new uses of pesticides if they conduct
SUPPLEMENTARY INFORMATION:
tkelley on DSK3SPTVN1PROD with NOTICES
a(b)]. experimental field tests on 10 acres or
Dated: July 17, 2015. I. General Information more of land or one acre or more of
water.
Jack Housenger, A. Does this action apply to me? Pursuant to 40 CFR 172.11(a), EPA
Director, Office of Pesticide Programs. This action is directed to the public has determined that the following EUP
[FR Doc. 2015–18612 Filed 7–28–15; 8:45 am] in general. Although this action may be application may be of regional and
BILLING CODE 6560–50–P of particular interest to those persons national significance, and therefore is
VerDate Sep<11>2014 17:33 Jul 28, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\29JYN1.SGM 29JYN1](https://thefederalregister.org/doc/80_FR_45363/page/2.svg)
Document Created: 2015-12-15 13:06:00
Document Modified: 2015-12-15 13:06:00
| 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 | Comments must be received on or before August 28, 2015. | |
| Contact | Monique Perron, Health Effects Division (7509P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- | |
| FR Citation | 80 FR 45218 |
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