51472 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 

The Pesticide Registration 

Improvement Act of 2003 (PRIA) was 

amended and extended in September 

2007. FIFRA as amended by PRIA in 

2007 requires EPA to complete 

registration review decisions by October 

1, 2022 for all pesticides registered as of 

October 1, 2007. The registration review 

final rule provides for a minimum 60– 

day public comment period for all 

proposed registration review decisions. 

This comment period is intended to 

provide an opportunity for public input 

and a mechanism for initiating any 

necessary amendments to the proposed 

decision. All comments should be 

submitted using the methods in 

ADDRESSES, and must be received by 

EPA on or before the closing date. These 

comments will become part of the 

Agency Docket for Nosema locustae. 

Comments received after the close of the 

comment period will be marked ‘‘late.’’ 

EPA is not required to consider these 

late comments. 

The Agency will carefully consider all 

comments received by the closing date 

and will provide a Response to 

Comments Memorandum in the Dockets 

and www.regulations.gov. The final 

registration review decisions will 

explain the effect that any comments 

have had on the decisions. Background 

on the registration review program is 

provided at: http://www.epa.gov/ 

oppsrrd1/registration_review/. Quick 

links to earlier documents related to the 

registration review of this pesticide are 

provided at: http://www.epa.gov/ 

oppsrrd1/registration_review/ 

reg_review_status.htm/. Additional 

information about biopesticides can be 

obtained by an alphabetical search of 

the Biopesticide Active Ingredient Fact 

Sheets on http://www.epa.gov/ 

oppbppd1/biopesticides/ingredients/ 

index.htm 

B. What is the Agency’s Authority for 

Taking this Action? 

FIFRA Section 3(g) and 40 CFR 155.40 

provide authority for this action. 

List of Subjects 

Environmental protection, registration 

review, pesticides, and pests. 

Dated: August 21, 2008. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention Division, Office of Pesticide 

Programs. 

[FR Doc. E8–20395 Filed 9–2–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPP–2007–1072; FRL–8346–4] 

Pesticide Reregistration Performance 

Measures and Goals 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This notice announces EPA’s 

progress in meeting its performance 

measures and goals for pesticide 

reregistration during fiscal year 2007. 

The Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) requires EPA 

to publish information about EPA’s 

annual achievements in this area. This 

notice discusses the integration of 

tolerance reassessment with the 

reregistration process, and describes the 

status of various regulatory activities 

associated with reregistration and 

tolerance reassessment. The notice gives 

total numbers of chemicals and 

products reregistered, tolerances 

reassessed, Data Call-Ins issued, and 

products registered under the ‘‘fasttrack’’ provisions of FIFRA. This notice 

also contains the schedule for 

completion of activities for specific 

chemicals during fiscal year 2008. 

DATES: This notice is not subject to a 

formal comment period. Nevertheless, 

EPA welcomes input from stakeholders 

and the general public. Written 

comments, identified by the docket 

identification (ID) number [EPA–HQ– 

OPP–2007–1072], should be received on 

or before November 3, 2008. 

ADDRESSES: Submit your comments, 

identified by docket ID number EPA– 

HQ–OPP–2007–1072, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov/. Follow the online instructions for submitting 

comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2007–1072. EPA’s policy is that all 

comments received will be included in 

the public docket without change and 

may be made available on-line at http:// 

www.regulations.gov/, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov website is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be captured automatically and 

included as part of the comment that is 

placed in the public docket and made 

available on the Internet. If you submit 

an electronic comment, EPA 

recommends that you include your 

name and other contact information in 

the body of your comment and with any 

disk or CD ROM you submit. If EPA 

cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider your comment. 

Electronic files should avoid the use of 

special characters, any form of 

encryption, and be free of any defects or 

viruses. For additional information 

about EPA’s public docket, visit the EPA 

Docket Center homepage at http:// 

www.epa.gov/epahome/docket.htm/. 

Docket: All documents in the docket 

are listed in the index. Although listed 

in the index, some information is not 

publicly available, i.e., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

will be publicly available only in hard 

copy. 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 OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South 

Building), 2777 S. Crystal Drive, 

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 

telephone number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Carol P. Stangel, Special Review and 

Reregistration Division (7508P), Office 

of Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460; 


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telephone: (703) 308–8007; e-mail: 

stangel.carol@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 persons who are 

interested in the progress and status of 

EPA’s pesticide reregistration and 

tolerance reassessment programs, 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 information in this notice, 

consult the person listed under FOR

FURTHER INFORMATION CONTACT. 

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 e-mail. 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 submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns, and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity, 

obscene language, or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline. 

II. Background 

EPA must establish and publish in the 

Federal Register its annual performance 

measures and goals for pesticide 

reregistration, tolerance reassessment, 

and expedited registration, under 

section 4(l) of FIFRA, 7 U.S.C. 136a-1(l). 

Specifically, such measures and goals 

are to include: 

• The status of reregistration. 

• The number of products 

reregistered, canceled, or amended. 

• The number and type of data 

requests or Data Call-In (DCI) notices 

under FIFRA section 3(c)(2)(B) issued to 

support product reregistration by active 

ingredient. 

• Progress in reducing the number of 

unreviewed, required reregistration 

studies. 

• The aggregate status of tolerances 

reassessed. 

• The number of applications for 

registration submitted under subsection 

(k)(3) (which provides for expedited 

processing and review of similar 

applications), that were approved or 

disapproved. 

• The future schedule for 

reregistrations in the current and 

succeeding fiscal year. 

• The projected year of completion 

of the reregistrations under section 4. 

FIFRA authorizes EPA to conduct a 

comprehensive pesticide reregistration 

program--a complete review of the 

human health and environmental effects 

of older pesticides originally registered 

before November 1, 1984. Pesticides 

meeting today’s scientific and regulatory 

standards may be declared ‘‘eligible’’ for 

reregistration. To be eligible, an older 

pesticide must have a substantially 

complete data base, and must not cause 

unreasonable adverse effects to human 

health or the environment when used 

according to Agency approved label 

directions and precautions. 

In addition, all pesticides with food 

uses must meet the safety standard of 

section 408 of the Federal Food, Drug, 

and Cosmetic Act (FFDCA) 21 U.S.C. 

346a. Under FFDCA, EPA must make a 

determination that pesticide residues 

remaining in or on food are ‘‘safe’’; that 

is, ‘‘that there is reasonable certainty 

that no harm will result from aggregate 

exposure to the pesticide chemical 

residue’’ from dietary and other sources. 

In determining allowable levels of 

pesticide residues in food, EPA must, 

among other requirements, perform a 

comprehensive assessment of each 

pesticide’s risks, considering: 

• Aggregate exposure (from food, 

drinking water, and residential uses). 

• Cumulative effects from all 

pesticides sharing a common 

mechanism of toxicity. 

• Possible increased susceptibility of 

infants and children. 

• Possible endocrine or estrogenic 

effects. 

The 1996 FFDCA amendments also 

required the reassessment of all existing 

tolerances (pesticide residue limits in 

food) and tolerance exemptions within 

10 years, to ensure that they met the 

safety standard of the law. EPA was 

directed to give priority to the review of 

those pesticides that appeared to pose 

the greatest risk to public health. The 

Agency completed over 99% of the 

required tolerance reassessment 

decisions by August 3, 2006, and upon 

concluding the N-methyl carbamate 

cumulative risk assessment, completed 

all 9,721 tolerance reassessment 

decisions in September 2007. These 

decisions represent significant 

enhancements in public health and 

environmental protection. By 

successfully implementing this 

provision of FFDCA, EPA is ensuring 

that all pesticides used on food in the 

United States meet the law’s safety 

standard. EPA’s approach to tolerance 

reassessment under FFDCA was 

described fully in the Agency’s 

document, ‘‘Raw and Processed Food 

Schedule for Pesticide Tolerance 

Reassessment’’ (62 FR 42020, August 4, 

1997) (FRL–5734–6). 

The Pesticide Registration 

Improvement Act (PRIA) of 2003 

became effective on March 23, 2004 (7 

U.S.C. 136w–8). Among other things, 

PRIA directed EPA to complete 

Reregistration Eligibility Decisions 

(REDs) for pesticides with food uses/ 

tolerances by August 3, 2006, and to 

complete all non-food use pesticide 

REDs by October 3, 2008. The Agency 

completed 99% of the REDs for 

pesticides with food uses due by August 

3, 2006, and plans to complete all 

remaining REDs by October 3, 2008. 

EPA’s schedule for meeting these 

deadlines is available on the Agency’s 

website at http://www.epa.gov/

pesticides/reregistration/

decision_schedule.htm. 

III. Program Accountability 

Through this summary of 

performance measures and goals for 

pesticide reregistration, tolerance 

reassessment, and expedited 

registration, EPA describes progress 

made during the past year in each of the 


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program areas included in FIFRA 

section 4(l). 

A. Status of Reregistration 

During fiscal year (FY) 2007 (from 

October 1, 2006, through September 30, 

2007), EPA made significant progress in 

completing risk assessments and risk 

management decisions for pesticide 

reregistration. The Agency’s decisions 

are embodied in RED documents. (See 

Table 1). 

TABLE 1.—REREGISTRATION/RISK

MANAGEMENT DECISIONS COMPLETED: IN FY 2007 AND FY 1991 

THROUGH FY 2007 

FY 2007 Decisions 

Total, FY 

1991 through 

FY 2007 

27 FY 2007 REDs 

Aldicarb 

Aliphatic alcohols, C6-C16 

Aliphatic esters 

Alkyl trimethylenediamines 

Allethrin stereoisomers 

4-Aminopyridine 

Antimycin A 

Benzoic acid 

Bioban-p-1487 

Bromonitrostyrene (Voluntary cancellation) 

Carbaryl 

Carbofuran (2006 IRED became a RED) 

Chlorflurenol 

2,4-DP-p (dichlorprop-p) 

Dikegulac sodium 

Flumetralin 

Formetanate hydrochloride 

(2006 IRED became a 

RED) 

Glutaraldehyde 

MCPP-p (mecoprop-p) 

Mefluidide 

Naphthenate salts 

Octhilinone 

Oxamyl (2000 IRED became a RED) 

p-Dichlorobenzene 

(paradichlorobenzene) 

Polypropylene glycol 

Rotenone 

Trimethoxysilyl quats 

357 REDS 

Through the reregistration program, 

EPA is reviewing current scientific data 

for older pesticides (those initially 

registered before November 1984), 

reassessing their effects on human 

health and the environment, and 

requiring risk mitigation measures as 

necessary. Pesticides that have 

sufficient supporting data and whose 

risks can be successfully mitigated may 

be declared ‘‘eligible’’ for reregistration. 

EPA presents these pesticide findings in 

a RED document. 

Three of the FY 2007 REDs were for 

the N-methyl carbamate pesticides 

carbofuran, formetanate hydrochloride, 

and oxamyl. EPA completed Interim 

REDs for these pesticides in earlier 

years. With completion of the N-methyl 

carbamate cumulative risk assessment 

in September 2007, these last Interim 

REDs became final REDs. Additional 

information is available on EPA’s 

Assessing Pesticide Cumulative Risk 

web page, http://www.epa.gov/ 

pesticides/cumulative/. 

1. Overall RED progress. EPA’s overall 

progress at the end of FY 2007 in 

completing REDs for groups of related 

pesticide active ingredients or cases is 

summarized in Table 2. 

TABLE 2.—OVERALL RED PROGRESS, 

FY 1991 THROUGH FY 2007 

REDs completed 357 (58%) 

Cases canceled 229 (37%) 

REDs to be completed 27 (5%) 

Total reregistration cases 613 

(100%) 

2. Risk reduction in REDs. Through 

the reregistration program, EPA seeks to 

reduce risks associated with the use of 

older pesticides. In developing REDs, 

EPA works with stakeholders including 

pesticide registrants, growers and other 

pesticide users, and environmental and 

public health interests groups, as well as 

the States and Tribes, USDA and other 

Federal agencies, and other entities to 

develop measures to effectively reduce 

risks of concern. Almost every RED 

includes some measures or 

modifications in how a pesticide can be 

legally used to reduce risks. The options 

for such risk reduction are extensive 

and include voluntary cancellation of 

pesticide products or deletion of uses; 

declaring certain uses ineligible or not 

yet eligible (and then proceeding with 

follow-up action to cancel the uses or 

require additional supporting data); 

restricting use of products to certified 

applicators; limiting the amount or 

frequency of use; improving use 

directions and precautions; requiring 

more protective clothing and 

equipment; requiring special packaging 

or engineering controls; requiring notreatment buffer zones; employing 

ground water, surface water, or other 

environmental and ecological 

safeguards; and other measures. 

3. Goal for FY 2008. EPA’s goal in 

conducting the reregistration program is 

to complete the remaining 27 REDs 

during FY 2008. EPA’s schedule for 

completing these decisions appears in 

Unit III.G., and also is available on the 

Agency’s website at http:// 

www.epa.gov/pesticides/reregistration/ 

decision_schedule.htm. 

B. Product Reregistration; Numbers of 

Products Reregistered, Canceled, and 

Amended 

At the end of the reregistration 

process, after EPA has issued a RED and 

declared a pesticide reregistration case 

eligible for reregistration, individual 

end-use products that contain pesticide 

active ingredients included in the case 

still must be reregistered. This 

concluding part of the reregistration 

process is called ‘‘product 

reregistration.’’ 

In issuing a completed RED 

document, EPA sends registrants a DCI 

notice requesting any product-specific 

data and specific revised labeling 

needed to complete reregistration for 

each of the individual pesticide 

products covered by the RED. Based on 

the results of EPA’s review of these data 

and labeling, products found to meet 

FIFRA and FFDCA standards may be 

reregistered. 

A variety of outcomes are possible for 

pesticide products completing this final 

phase of the reregistration process. 

Ideally, in response to the DCI notice, 

the pesticide producer, or registrant, 

will submit the required productspecific data and revised labeling, 

which EPA will review and find 

acceptable. At that point, the Agency 

may reregister the pesticide product. If, 

however, the product contains multiple 

active ingredients, the Agency instead 

would first require the registrant to 

amend the product’s registration, 

incorporating the labeling changes 

specified in the RED as interim 

measures. A product with multiple 

active ingredients may not be fully 

reregistered until the last active 

ingredient in its formulation is eligible 

for reregistration. In other situations, the 

Agency may temporarily suspend a 

product’s registration if the registrant 

has not submitted required productspecific studies within the time frame 

specified. The Agency may cancel a 

product’s registration because the 

registrant did not pay the required 

registration maintenance fee. 

Alternatively, the registrant may request 

a voluntary cancellation of their end-use 

product registration. 

EPA counts each of the post-RED 

product outcomes described above as a 

product reregistration action. A single 

pesticide product may be the subject of 

several product reregistration actions 

within the same year. For example, a 

product’s registration initially may be 

amended, then the product may be 

reregistered, or the product may first be 

suspended and later it may be 


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voluntarily canceled. EPA also keeps 

track of the status of the universe of 

pesticide products subject to 

reregistration, that is, the overall 

number of products reregistered, 

amended, canceled, and sent for 

suspension, as well as the number of 

products with actions pending, as of the 

end of each fiscal year. 

In response to May 2008 draft 

findings and recommendations by EPA’s 

Office of the Inspector General resulting 

from the annual FIFRA Financial 

Statements Audit, the EPA Office of 

Pesticide Programs (OPP) is reviewing 

and strengthening its internal processes 

and controls for handling and 

electronically managing information 

concerning product reregistration 

actions and accomplishments. OPP 

expects to complete this review by 

December 31, 2008. In next year’s 

Performance Measures and Goals 

Federal Register notice reporting on 

actions completed in FY 2008, the 

Agency plans to provide numbers of 

product reregistration actions completed 

in FY 2007 and in FY 2008. 

EPA’s goal is to complete 1,000 

product reregistration actions during FY 

2008. 

C. Number and Type of DCIs to Support 

Product Reregistration by Active 

Ingredient 

The number and type of productspecific Data Call-In (PDCI) requests that 

EPA is preparing to issue under FIFRA 

section 3(c)(2)(B) to support product 

reregistration for pesticide active 

ingredients included in FY 2007 REDs 

are shown in Table 3. 

TABLE 3.—DCIS TO SUPPORT PRODUCT REREGISTRATION FOR FY 2007 REDS

Case Name Case No. 

Number of Products Covered by 

the RED1

Number of Product 

Chemistry Studies 

Required2

Number of Acute 

Toxicology Studies 

Required3

Number of Efficacy 

Studies Required 

Aldicarb 0140 39 31 12 (2 batches) 0 

Aliphatic Alcohols, C6-C16 4004 22 31 54 (5 batches/4 products not batched) 0 

Aliphatic Esters 4005 1 31 6 (1 product not 

batched) 

0 

Alkyl Trimethylenediames 3014 13 34 Antimicrobial RED-- 

Acute toxicity 

batching has not 

been completed 

PDCI has not been 

completed 

Allethrin Stereoisomers 0437 251 31 Acute toxicity batching has not been 

completed 

0 

4-Aminopyridine 0015 10 31 PDCI and Acute toxicity batching have 

not been completed 

PDCI has not been 

completed 

Antimycin-A 4121 1 31 6 (1 product not 

batched) 

0 

Benzoic Acid 4013 11 31 Acute toxicity batching has not been 

completed 

0 

Bioban-p-1487 3028 5 34 Antimicrobial RED -- 

Acute toxicity 

batching has not 

been completed 

PDCI has not been 

completed 

Bromonitrostyrene (Voluntary 

Cancellation) 

2065 6 NA NA NA 

Carbaryl4 0080 101 NA NA NA 

Carbofuran4 0101 88 NA NA NA 

Chlorflurenol 2095 5 31 30 (5 products not 

batched) 

0 

Chlormequat Chloride 3003 4 31 24 (4 products not 

batched) 

0 

Copper-8-Quinolate 4026 28 34 Antimicrobial RED-- 

Acute toxicity 

batching has not 

been completed 

PDCI has not been 

completed 


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TABLE 3.—DCIS TO SUPPORT PRODUCT REREGISTRATION FOR FY 2007 REDS—Continued 

Case Name Case No. 

Number of Products Covered by 

the RED1

Number of Product 

Chemistry Studies 

Required2

Number of Acute 

Toxicology Studies 

Required3

Number of Efficacy 

Studies Required 

2,4-DP-p (dichorprop-p) 0294 63 31 Acute toxicity batching has not been 

completed 

0 

Dikegulac Sodium 3061 2 31 12 (2 products not 

batched) 

0 

Flumetralin 4119 6 31 Acute toxicity batching has not been 

completed 

PDCI has not been 

completed 

Formetanate HCl4 0091 6 NA NA NA 

Glutaraldehyde 2315 59 34 Antimicrobial RED-- 

Acute toxicity 

batching has not 

been completed 

PDCI has not been 

completed 

Mecoprop-p (MCPP-p) 0377 314 31 Acute toxicity batching has not been 

completed 

0 

Mefluidide 2370 12 31 48 (2 batches/6 products not batched) 0 

Naphthenate Salts 3099 49 34 Antimicrobial RED-- 

Acute toxicity 

batching has not 

been completed 

PDCI has not been 

completed 

Octhilinone 2475 37 34 Antimicrobial RED-- 

Acute toxicity 

batching has not 

been completed 

PDCI has not been 

completed 

Oxamyl4 0253 12 NA NA NA 

Para-Dichlorbenzene 3058 28 31 Acute toxicity batching has not been 

completed 

0 

Polypropylene Glycol 

(Butoxypolypropylene Glycol) 

3123 53 31 PDCI and Acute toxicity batching have 

not been completed 

PDCI has not been 

completed 

Rotenone 0255 50 31 Acute toxicity batching has not been 

completed 

PDCI has not been 

completed 

Trimethoxysilyl Quats 31485 30 34 Antimicrobial RED-- 

Acute toxicity 

batching has not 

been completed 

PDCI has not been 

completed 

Total No. of Products --- 1,306 --- --- --- 

1The number of registered products containing a pesticide active ingredient can change over time. The product total that appears in the RED 

document (counted when the RED is signed) may be different than the number of products that EPA is tracking for product reregistration (counted later, when the RED is issued). This table reflects the current number of products associated with each RED, as they are being tracked for 

product reregistration. 2This column shows the number of product chemistry studies that are required for each product covered by the RED. 

3 In an effort to reduce the time, resources, and number of animals needed to fulfill acute toxicity data requirements, EPA batches products 

that can be considered similar from an acute toxicity standpoint. For example, 1 batch could contain 5 products. In this instance, if 6 acute toxicology studies usually were required per product, only 6 studies (rather than 30 studies) would be required for the entire batch. Factors considered in the sorting process include each product’s active and inert ingredients (e.g., identity, percent composition, and bioIogical activity), type of 

formulation (e.g., emulsifiable concentrate, aerosol wettable powder, granular), and labeling (e.g., signal word, use classification, precautionary 

labeling). The Agency does not describe batched products as substantially similar, because all products within a batch may not be considered 

chemically similar or have identical use patterns. (Note: FIFRA section 24(c) or Special Local Need (SLN) registrations are not included in the 

acute toxicity batchings because they are supported by a valid parent product (section 3) registration.) 4These 4 chemicals were addressed in IREDs issued in previous fiscal years. At that time, PDCIs were approved and/or issued for Carbaryl, 

Formetanate HCl, and Oxamyl. A PDCI was not issued for Carbofuran because its products were declared ineligible for reregistration. These 

IREDs became REDs in September 2007 when the N-Methyl Carbamate cumulative risk assessment was completed. Additional PDCIs will not 

be issued for these REDs. 


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5Two additional active ingredients were significantly similar to Trimethoxysiyl Quats (Case 3148) and were included in the Trimethoxysiyl 

Quats case before the RED was completed. 

D. Progress in Reducing the Number of 

Unreviewed, Required Reregistration 

Studies 

Although EPA made progress during 

FY 2007 in reviewing scientific studies 

submitted by registrants in support of 

pesticides undergoing reregistration, the 

percent of studies reviewed remained 

constant (See Table 4). The Agency is 

considering options for categorizing 

reregistration studies more precisely. 

TABLE 4.—REVIEW STATUS OF STUDIES SUBMITTED FOR PESTICIDE REREGISTRATION, END OF FY 2007 

Pesticide Reregistration List, per 

FIFRA Section 4(c)(2) Studies Reviewed + Extraneous1 Studies Awaiting Review Total Studies Received 

List A 11,283 + 603 = 11,886 (87%) 1,788 (13%) 13,674 

List B 6,630 + 1,061 = 7,691 (81.5%) 1,748 (18.5%) 9,439 

List C 2,098 + 334 = 2,432 (84%) 463 (16%) 2,895 

List D 1,275 + 134 = 1,409 (86%) 228 (14%) 1,637 

Total Lists A - D 21,286 + 2,132 = 23,418 (84.7%) 4,227 (15.3%) 27,645 (100%) 

1Extraneous studies is a term used to classify those studies that are not needed because the guideline or data requirement has been satisfied 

by other studies or has changed. 

E. Aggregate Status of Tolerances 

Reassessed 

During FY 2007, EPA completed 84 

tolerance reassessment decisions for the 

N-methyl carbamate pesticides. With 

these reassessments, the Agency 

addressed 100% of the 9,721 tolerances 

that required reassessment (See Table 

5). 

EPA’s general schedule for tolerance 

reassessment (62 FR 42020, August 4, 

1997) identified three groups of 

pesticides to be reviewed; this grouping 

reflected the Agency’s overall 

scheduling priorities. In completing 

tolerance reassessment, EPA gave 

priority to pesticides in Group 1, the 

Agency’s highest priority group for 

reassessment. 

1. Aggregate accomplishments 

through reregistration and other 

programs. EPA accomplished tolerance 

reassessment through pesticide 

registration and reregistration; by 

revoking tolerances for pesticides that 

have been canceled (many as a result of 

reregistration); by reevaluating 

pesticides with REDs issued prior to 

August 1996; and through other 

decisions not directly related to 

registration or reregistration, described 

further below. EPA used the Tolerance 

Reassessment Tracking System (TORTS) 

to compile this updated information and 

report on the status of tolerance 

reassessment (See Table 5). 

TABLE 5.—TOLERANCE REASSESSMENTS COMPLETED POST-FQPA BY FISCAL YEAR, THROUGH FY 20071

Tolerances Reassessed 

Through... 

Late 

FY 96 

FY 

1997 

FY 

1998 

FY 

1999 

FY 

2000 

FY 

2001 

FY 

2002 

FY 

2003 

FY 

2004 

FY 

2005 

FY 

2006 

FY 

2007 

Total, 

End 

of FY 

2007 

Reregistration/REDs 25 339 277 359 44 46 231 79 84 413 1,037 84 3,018 

Tolerance Reassessments/ 

TREDs 0 0 0 0 0 0 776 15 119 69 305 0 1,284 

Registration 0 224 308 340 55 216 200 0 69 0 1 0 1,413 

Tolerance revocations 3 0 812 513 22 35 545 0 174 112 185 0 2,401 

Other decisions including 

inerts 0 1 0 233 0 0 905 26 21 128 291 0 1,605 

Total tolerances reassessed 28 564 1,397 1,445 121 297 2,657 120 467 722 1,819 84 9,721 

1Includes corrected counts for some previous years. 

i. Reregistration/REDs. EPA used the 

reregistration program to accomplish 

much of tolerance reassessment. For 

each of the tolerance reassessment 

decisions made through REDs since 

August 1996, the Agency has made the 

finding as to whether there is a 

reasonable certainty of no harm, as 

required by FFDCA. Many tolerances 

reassessed through reregistration 

remained the same while others were 

raised, lowered, or revoked. 

ii. Tolerance reassessments/TREDs. 

Tolerances initially evaluated through 

REDs that were completed before 

August 1996 were reassessed to ensure 

that they met the new FFDCA safety 

standard. EPA issued these post-RED 

tolerance reassessment decisions as 

TREDs. The Agency also issued TREDs 

summarizing tolerance reassessment 

decisions for some REDs under 

development, for new pesticide active 

ingredients not subject to reregistration, 


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51478 Federal Register / Vol. 73, No. 171 / Wednesday, September 3, 2008 / Notices 

and for pesticides with import 

tolerances only. 

iii. Registration. Like older pesticides, 

all new pesticide registrations must 

meet the safety standard of FFDCA. 

Many of the registration applications 

EPA receives are for new uses of 

pesticides already registered for other 

uses. To reach a decision on a proposed 

new food use of an already registered 

pesticide, EPA must reassess the 

aggregate risk of the the existing 

tolerances, as well as the proposed new 

tolerances, to make sure there is 

reasonable certainty that no harm will 

result to the public from aggregate 

exposure from all uses. 

iv. Tolerance revocations. When EPA 

has canceled use on a particular crop or 

commodity of all products containing a 

pesticide active ingredient, the Agency 

ordinarily will revoke the tolerance, 

unless a party provides data to support 

it as an import tolerance. Some 

pesticides were canceled due to the 

Agency’s risk concerns. Others were 

canceled voluntarily by their 

manufacturers, based on economic 

decisions not to support reregistration. 

Tolerance revocations are important 

even if there are no domestic uses of a 

pesticide because residues in or on 

imported commodities treated with the 

chemical could still present dietary 

risks that may exceed the FFDCA 

‘‘reasonable certainty of no harm’’ 

standard, either individually or 

cumulatively with other substances that 

share a common mechanism of toxicity. 

v. Other reassessment decisions. In 

addition to the types of reassessment 

actions described above, a total of 1,605 

additional tolerance reassessment 

decisions were made. Some were made 

for inert ingredient tolerance 

exemptions through actions not directly 

related to registration or reregistration. 

2. Accomplishments for priority 

pesticides. During FY 2007, EPA 

completed the remaining 84 tolerance 

reassessment decisions for the high 

priority N-methyl carbamate pesticides. 

This completes the reassessment of 

priority pesticides. 

F. Applications for Registration 

Requiring Expedited Processing; 

Numbers Approved and Disapproved 

By law, EPA must expedite its 

processing of certain types of 

applications for pesticide product 

registration, i.e., applications for enduse products that would be identical or 

substantially similar to a currently 

registered product; amendments to 

current product registrations that do not 

require review of scientific data; and 

products for public health pesticide 

uses. During FY 2007, EPA considered 

and approved the numbers of 

applications for registration requiring 

expedited processing (also known as 

‘‘fast track’’ applications) shown in 

Table 6. 

TABLE 6.—FAST TRACK APPLICATIONS

APPROVED IN FY 2007 

Me-too product registrations/Fast 

track 

394 

Amendments/Fast track 3,441 

Total applications processed by 

fast track means 

3,835 

For those applications not approved, 

the Agency generally notifies the 

registrant of any deficiencies in the 

application that need to be corrected or 

addressed before the application can be 

approved. Applications may have been 

withdrawn after discussions with the 

Agency, but none were formally 

‘‘disapproved’’ during FY 2007. 

On a financial accounting basis, EPA 

devoted 25.4 full-time equivalents 

(FTEs) in FY 2007 to reviewing and 

processing applications for fast track 

me-too product registrations and label 

amendments. The Agency spent 

approximately $3.15 million in FY 2007 

in direct costs (i.e., time on task, not 

including administrative expenses, 

computer systems, management 

overhead, and other indirect costs) on 

expedited processing and reviews. 

G. Future Schedule for Reregistrations 

EPA plans to complete the remaining 

27 REDs in FY 2008, meeting the 

October 3, 2008 PRIA deadline. The 

Agency’s schedule for completing these 

decisions is as follows. This schedule 

also is available on EPA’s website at 

http://www.epa.gov/pesticides/ 

reregistration/decision_schedule.htm. 

List 1.—FY 2008 REDs Schedule 

Acrolein 

Busan 77 

Chloropicrin 

Chromated arsenicals (CCA) 

Coal tar/creosote 

Dazomet 

Diiodomethyl p-tolyl sulfone (Amical 

48) 

Ethylene oxide (ETO) (TRED 

completed in FY 2006) 

Formaldehyde 

Grotan 

Inorganic thiosulfates (ammonium 

thiosulfate) 

Methyl bromide (soil fumigant uses; 

commodity uses TRED & RED 

completed FY 2006) 

Methyldithiocarbamate salts (metam 

sodium/metam potassium) 

MITC (methyl isothiocyanate) 

Naphthalene 

Nicotine 

Organic esters of phosphoric acid 

Pentachlorophenol 

Prometon 

Siduron 

Sodium fluoride 

Sulfometuron methyl 

Sumithrin 

Tetramethrin 

Tributyltin-containing compounds 

Triclosan (Irgasan) 

Triforine 

H. Projected Year of Completion of 

Reregistrations 

EPA expects to complete 27 

remaining reregistration eligibility 

decisions in FY 2008. Product 

reregistration, which takes place only 

after the reregistration eligibility 

decisions have been completed for the 

active ingredients, will not likely be 

completed before 2014. 

List of Subjects 

Environmental protection, Pesticides 

and pests. 

Dated: August 22, 2008. 

James B. Gulliford, 

Assistant Administrator, Office of Prevention, 

Pesticides and Toxic Substances. 

[FR Doc. E8–20236 Filed 9–2–08; 8:45 am] 

BILLING CODE 6560–50–S 

FARM CREDIT SYSTEM INSURANCE 

CORPORATION 

Farm Credit System Insurance 

Corporation Board; Regular Meeting 

SUMMARY: Notice is hereby given of the 

regular meeting of the Farm Credit 

System Insurance Corporation Board 

(Board). 

Date and Time: The meeting of the 

Board will be held at the offices of the 

Farm Credit Administration in McLean, 

Virginia, on September 11, 2008, from 

10 a.m. until such time as the Board 

concludes its business. 

FOR FURTHER INFORMATION CONTACT: 

Roland E. Smith, Secretary to the Farm 

Credit System Insurance Corporation 

Board, (703) 883–4009, TTY (703) 883– 

4056. 

ADDRESSES: Farm Credit System 

Insurance Corporation, 1501 Farm 

Credit Drive, McLean, Virginia 22102. 

SUPPLEMENTARY INFORMATION: Parts of 

this meeting of the Board will be open 

to the public (limited space available) 

and parts will be closed to the public. 

In order to increase the accessibility to 

Board meetings, persons requiring 

assistance should make arrangements in 

advance. The matters to be considered 

at the meeting are: 


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