45218 Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Notices 

listing of 279 water body-pollutant 

combinations and associated priority 

rankings, and proposed to disapprove 

Louisiana’s decisions not to list 43 

water quality limited segments and 

associated pollutants constituting 93 

waterbody-pollutant combinations. On 

July 21, 2015, EPA finalized the action 

to disapprove Louisiana’s 2014 listing 

decisions not to list 43 water quality 

limited segments. EPA identified these 

additional waters for inclusion on the 

2014 Section 303(d) List. 

Dated: July 21, 2015. 

William K. Honker, 

Director, Water Quality Protection Division, 

Region 6. 

[FR Doc. 2015–18523 Filed 7–28–15; 8:45 am] 

BILLING CODE 6560–50–P 

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availability of draft guidance, Pesticide 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 riskbased 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: 

perron.monique@epa.gov 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: 

wilbur.donald@epa.gov. 

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 


tkelley on DSK3SPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 145 / Wednesday, July 29, 2015 / Notices 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 § 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 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2015–0374; FRL–9930–74] 

Pesticide Experimental Use Permit; 

Receipt of Application; Comment 

Request 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces EPA’s 

receipt of an application (88877–EUP–E) 

from the University of Kentucky’s 

Department of Entomology requesting 

an experimental use permit (EUP) for 

Wolbachia pipientis, wAlbB Strain. EPA 

has determined that the permit may be 

of regional and national significance. 

Therefore, because of the potential 

significance, EPA is seeking comments 

on this application. 

DATES: Comments must be received on 

or before August 28, 2015. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2015–0374, 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: 

Robert McNally, Director, Biopesticides 

and Pollution Prevention Division 

(7511P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

BPPDFRNotices@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

This action is directed to the public 

in general. Although this action may be 

of particular interest to those persons 

who conduct or sponsor research on 

pesticides, EPA 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 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. 

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, EPA 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 pesticide discussed in this 

document, compared to the general 

population. 

II. What action is EPA taking? 

Under section 5 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA), 7 U.S.C. 136c, EPA can 

allow manufacturers to field test 

pesticides under development. 

Manufacturers are required to obtain an 

EUP before testing new pesticides or 

new uses of pesticides if they conduct 

experimental field tests on 10 acres or 

more of land or one acre or more of 

water. 

Pursuant to 40 CFR 172.11(a), EPA 

has determined that the following EUP 

application may be of regional and 

national significance, and therefore is 


tkelley on DSK3SPTVN1PROD with NOTICES