[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SUMMARY: EPA is announcing the availability of draft guidance, 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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