[Federal Register Volume 80, Number 145 (Wednesday, July 29, 2015)]
[Notices]
[Pages 45218-45219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18612]
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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.
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SUMMARY: EPA is announcing the availability of draft guidance,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]
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