Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Notices 60113 

Those persons who are or may be 

required to conduct testing of chemical 

substances under the Federal Food, 

Drug and Cosmetics Act (FFDCA), or the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). 

B. How can I get copies of this document 

and other related information? 

1. Docket. EPA has established a 

docket for this action under docket ID 

number EPA–HQ–OPP–2010–0001. 

Publicly available docket materials are 

available either in the electronic docket 

at http://www.regulations.gov, or, if only 

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The hours of 

operation of this Docket Facility are 

from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the Federal Register listings at 

http://www.epa.gov/fedrgstr. 

II. Background 

1. SFIREG/EQI letter re: 

environmental and human health 

benchmarks. 

2. EPA use of monitoring data vs. use 

of modeling outputs in registration 

review process. 

3. Endangered Species—bulletins 

update, possible rulemaking procedure, 

new biological opinions. 

4. Bed bugs: ‘‘One State’s Experience’’, 

EPA taskforce update, misuse of 

pesticide products, proposed next steps. 

5. Water quality Pesticide Regulatory 

Education Program (PREP) update. 

6. Water quality PREP—National 

Pollution Discharge Elimination System 

(NPDES) discussions. 

7. NPDES permit update—rollout, 

feedback and comments, EPA responses, 

NPDES/FIFRA Workgroup meeting, next 

steps. 

8. Pesticide Of Interest Tracking 

System (POINTS) database—reporting 

and use update. 

9. OPP and OECA updates. 

10. Office of Water updates—Drinking 

water strategy. 

11. Status of deleted and underreview pesticides (endosulfan, atrazine), 

pyrethoids and pyrethrins reevaluation, 

chlorpyrifos lawsuit, and usefulness to 

the states of Study Profile Templates for 

pesticide registration applications? 

12. Canary software—detect 

intentional or unintentional 

contamination in drinking water 

systems. 

II. How can I request to participate in 

this meeting? 

This meeting is open for the public to 

attend. You may attend the meeting 

without further notification. Non EPA 

attendees will need to be signed in at 

lobby security and escorted to the fourth 

floor meeting room. 

List of Subjects 

Environmental protection. 

Dated: September 17, 2010. 

Kevin Keaney, 

Acting Director, Field and External Affairs 

Division, Office of Pesticide Programs. 

[FR Doc. 2010–24435 Filed 9–28–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2008–0935; FRL–8804–7] 

Pesticide Science Policy; Notice of 

Withdrawal 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: EPA announces the 

withdrawal of the pesticide science 

policy document ‘‘Use of the Pesticide 

Data Program (PDP) in Acute Risk 

Assessment.’’ In estimating dietary 

exposure to pesticides, the Agency uses 

a variety of data and different models. 

This science policy document was 

developed to explain a particular 

statistical methodology, known as 

decomposition, for using information 

from the U.S. Department of 

Agriculture’s (USDA) Pesticide Data 

Program (PDP) in risk assessments of 

acute exposure to pesticide residues in 

food. EPA is withdrawing this policy 

because EPA has been using a less 

resource-intensive and generally 

comparable method of analyzing data on 

pesticide residues. This action is in 

response to the recommendations made 

by EPA’s Office of Inspector General 

during its review of EPA’s 

implementation of the Food Quality and 

Protection Act (FQPA). In its report 

‘‘Opportunities to Improve Data Quality 

and Children’s Health through the 

FQPA’’ issued January 10, 2006, the 

Office of Inspector General 

recommended that EPA should update 

the status of its Science Policy issue 

papers. This Federal Register notice 

updates the public on the status of one 

of those papers. EPA is withdrawing 

this policy because EPA has been using 

a less resource-intensive and generally 

comparable method of analyzing data on 

pesticide residues. 

FOR FURTHER INFORMATION CONTACT: 

David J. Miller, Health Effects Division, 

Office of Pesticide Programs (7509P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001; telephone number: 

(703) 305-5352; fax number: (703) 305- 

5147; e-mail address: 

miller.davidj@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general. This action, however, may be 

of interest to persons who produce or 

formulate pesticides or who register 

pesticide products. 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. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

B. How Can I Get Copies of this 

Document and Other Related 

Information? 

1. Docket. EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0935. Publicly available 

docket materials are available either in 

the electronic docket at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S-4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The hours of 

operation of this Docket Facility are 

from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305-5805. 

2. Electronic access. You may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. 

II. Discussion 

A. Background on the Food Quality 

Protection Act of 1996 

The Food Quality Protection Act of 

1996 (FQPA) significantly amended the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) and the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). Among other changes, FQPA 

established a stringent health-based 

standard (‘‘a reasonable certainty of no 

harm’’) for pesticide residues in foods to 

assure protection from unacceptable 

pesticide exposure and strengthened 


erowe on DSK5CLS3C1PROD with NOTICES
60114 Federal Register / Vol. 75, No. 188 / Wednesday, September 29, 2010 / Notices 

health protections for infants and 

children from pesticide risks. 

During 1998 and 1999, EPA and the 

U.S. Department of Agriculture (USDA) 

established a subcommittee of the 

National Advisory Council for 

Environmental Policy and Technology 

(NACEPT), the Tolerance Reassessment 

Advisory Committee (TRAC), to address 

FFDCA issues and implementation. 

TRAC comprised more than 50 

representatives of affected user, 

producer, consumer, public health, 

environmental, states, and other 

interested groups. The TRAC met from 

May 27, 1998, through April 29, 1999. 

As a result of the 1998 and 1999 

TRAC process, EPA decided that the 

FQPA implementation process and 

related policies would benefit from 

providing notice and comment on the 

major science policy issues. The TRAC 

identified nine science policy areas it 

believed were key to implementation of 

tolerance reassessment. EPA agreed to 

provide an opportunity for public 

comment on each of the nine issues by 

announcing their availability in the 

Federal Register. In a notice published 

in the Federal Register of October 29, 

1998 (63 FR 58038) (FRL–6041–5), EPA 

described its intended approach. Since 

then, EPA has issued a series of draft 

and revised documents concerning the 

nine science policy issues. Publication 

of today’s notice is intended to update 

the public on the status of the science 

paper ‘‘Use of the Pesticide Data 

Program (PDP) in Acute Risk 

Assessment.’’ 

B. EPA’s Use of a Decomposition 

Methodology for Acute Dietary Risk 

Assessment 

In May 1999, EPA published the 

policy paper ‘‘Use of the Pesticide Data 

Program (PDP) in Acute Risk 

Assessment’’ (http://www.epa.gov/ 

fedrgstr/EPA-PEST/1999/May/Day-26/ 

p13034.htm) for public comment. This 

science policy document was developed 

to explain a particular statistical 

methodology, known as decomposition, 

for using information from the U.S. 

Department of Agriculture’s (USDA) 

PDP in risk assessments of acute 

exposure to pesticide residues in food. 

The PDP tests commodities in the U.S. 

food supply for pesticide residues. The 

decompositing methodology consists of 

extrapolating from data on pesticide 

residues in composite samples of fruits 

and vegetables to residue levels in 

single units of fruits and vegetables. 

Prior to publishing this policy, EPA 

policy did not use PDP residue data in 

acute dietary exposure assessments 

because of a concern that using these 

composite results could produce 

exposure estimates that would be biased 

low, underestimating high-end pesticide 

residues, and therefore would be 

inappropriate for human health risk 

assessments. Using a decompositing 

methodology could address these 

concerns. 

OPP consulted the FIFRA Scientific 

Advisory Panel (SAP) in 1999 and 2000 

on a variety of decomposition 

methodologies and technical issues 

surrounding the use of those 

methodologies. The SAP reports from 

those meetings are available at: http:// 

www.epa.gov/scipoly/SAP/meetings/ 

1999/may/final.pdf and http:// 

www.epa.gov/scipoly/sap/meetings/ 

2000/february/ 

partialfinalreport06292000.pdf. The 

SAP recommended that the Agency use 

decompositing and stated that ‘‘for acute 

dietary exposure estimation, it is the 

residues in single items of produce that 

are of interest rather than ‘‘average’’ 

residues measured in composited 

samples.’’ The Panel concluded that 

overall, a methodology called MaxLIP 

was the preferred method, but 

recommended additional studies and 

validation using actual individual 

samples of residues to develop a more 

complete understanding of methods of 

analysis. 

For a time, OPP incorporated 

decomposition into risk assessment of 

acute exposure to pesticide residues in 

food. However, due to the timeconsuming nature of the analysis, 

combined with the perception that 

utilizing decomposition was not making 

much of a difference in terms of risk 

estimates, the practice was 

discontinued. OPP has continued to 

evaluate the impact of conducting acute 

dietary risk assessments using residue 

levels measured in composite samples 

versus residue levels estimated to be 

present in decomposited samples. The 

key question has been the degree to 

which use of composite samples may 

underestimate risk at the high end of the 

exposure distribution. This assessment, 

though still exploratory, confirms OPP’s 

initial impression that decomposition 

does not have a critical influence on the 

risk assessment. While, as expected, the 

results vary for each pesticidecommodity combination, findings 

suggest that use of composite residues 

may result in estimated exposures that 

are reasonably similar to those resulting 

from single-units (i.e., decomposited 

results). 

III. International Interest in Working 

Together on Dietary Risk Assessment 

Analysis 

EPA’s evaluation of the impact of 

decompositing is ongoing. Currently, 

EPA is in the process of comparing 

results from the decomposition 

methodology to a method known as the 

‘‘variability factor’’ used in other 

countries, including the member States 

in the European Union. EPA anticipates 

working collaboratively with the 

European Union, through the European 

Food Safety Authority (EFSA), to share 

data, to better characterize the 

differences between the two 

methodologies, and to better understand 

the risk assessment and risk 

management implications. EPA believes 

that seeking to develop a globally 

harmonized approach in this aspect of 

dietary risk assessment will benefit all 

involved by increasing understanding 

and facilitating the sharing of data as 

well as the assessments derived from 

those data. In addition, the process will 

facilitate better understanding and 

resolutions of trade questions and issues 

that may result from differences in 

approach. 

IV. Withdrawing this Science Policy is 

Responsive to EPA’s Office of Inspector 

General’s Recommendations 

This action is responsive to the 

recommendations made by EPA’s Office 

of Inspector General during its review of 

EPA’s implementation of FQPA. In its 

report ‘‘Opportunities to Improve Data 

Quality and Children’s Health through 

the FQPA’’ issued January 10, 2006, 

http://www.epa.gov/oig/reports/2006/ 

20060110-2006-P-00009.pdf, the Office 

of Inspector General recommended that 

EPA should update the status of its 

Science Policy issue papers. This 

Federal Register notice updates the 

public on the status of one of the 

Science Policy papers. 

List of Subjects 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests. 

Dated: September 22, 2010. 

Steve A. Owens, 

Assistant Administrator, Office of Chemical 

Safety and Pollution Prevention. 

[FR Doc. 2010–24307 Filed 9–28–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2010–0248; FRL–8845–9] 

Notice of Receipt of Requests for 

Amendments to Delete Uses in Certain 

Pesticide Registrations 

AGENCY: Environmental Protection 

Agency (EPA). 


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