Wednesday, 

August 9, 2006 

Part IV 

Environmental 

Protection Agency 

40 CFR Parts 9 and 155 

Pesticides; Procedural Regulations for 

Registration Review; Final Rule 


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ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 9 and 155 

[EPA–HQ–OPP–2004–0404; FRL–8080–4] 

RIN 2070–AD29 

Pesticides; Procedural Regulations for 

Registration Review 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This rule establishes 

procedures for conducting the pesticide 

registration review program mandated 

by the Federal Insecticide, Fungicide, 

and Rodenticide Act. Under this rule, 

EPA will review existing pesticide 

registrations to determine whether they 

continue to meet the statutory standard 

for registration. The registration review 

program will begin in the fall of 2006. 

This rule provides for the establishment 

of pesticide cases for review, the 

scheduling of reviews, the initiation, 

completion and documentation of 

reviews, and associated public 

participation procedures. The 

registration review program established 

by this regulation is intended to ensure 

that all pesticide registrations are 

systematically reviewed in a manner 

that is based on sound science and 

provides for public participation, 

transparency and efficiency to protect 

public health and the environment. In 

addition, in order to display the OMB 

control number for the information 

collection requirements contained in 

this final rule, EPA is amending the 

table of OMB approval numbers for EPA 

regulations. 

DATES: This final rule is effective on 

October 10, 2006. 

ADDRESSES: EPA has established a 

docket for this action under Docket 

identification (ID) number EPA–HQ– 

OPP–2004–0404. All documents in the 

docket are listed in the docket index at 

http://www.regulations.gov. Although 

listed in the index, some information is 

not publicly available, e.g., CBI or other 

information whose disclosure is 

restricted by statute. Certain other 

material, such as copyrighted material, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. 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 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 Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Vivian Prunier, Field and External 

Affairs Division (7506P), Office of 

Pesticide Programs, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: 703–308–9341; 

fax number: 703–305–5884; e-mail 

address: prunier.vivian@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you hold pesticide 

registrations. Pesticide users or other 

persons interested in the regulation of 

the sale, distribution or use of pesticides 

may also be interested in this 

procedural regulation. Potentially 

affected entities may include, but are 

not limited to: 

• Producers of pesticide products 

(NAICS code 32532). 

• Producers of antifoulant paints 

(NAICS code 32551). 

• Producers of antimicrobial 

pesticides (NAICS code 32561). 

• Producers of nitrogen stabilizer 

products (NAICS code 32531). 

• Producers of wood preservatives 

(NAICS code 32519). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. To determine whether 

you or your business may be affected by 

this action, you should carefully 

examine the applicability provisions in 

§ 155.40 of the rule. 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 Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using http:// 

www.regulations.gov to access this 

document and other related information 

in the electronic docket, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

II. Overview of this Document 

In this document, EPA presents its 

response to comments on the proposed 

rule to establish procedural regulations 

for the registration review of pesticides. 

In response to comments, EPA is 

modifying some aspects of the rule 

relating to procedures for public 

participation in the registration review 

process. The differences between the 

proposed rule and the final rule are 

described in Units VI. and X. 

In this document, the Agency 

describes: 

• Statutory authority. 

• History of this rulemaking. 

• Response to comments on the rule. 

• Response to comments on the 

operation and implementation of the 

program. 

• Results of reviews required by 

statutes or executive orders. 

• Changes to the rule. 

• Procedural regulations for the 

registration review of pesticides. 

III. Authority 

A. EPA’s Authority to License Pesticides 

FIFRA section 3(a) generally requires 

a person to register a pesticide product 

with the EPA before the pesticide 

product may be lawfully distributed or 

sold in the U.S. A pesticide registration 

is a license that allows a pesticide 

product to be distributed or sold for 

specific uses under specified terms and 

conditions. A pesticide product may be 

registered or remain registered only if it 

meets the statutory standard for 

registration given in FIFRA section 

3(c)(5), as follows: 

(A) its composition is such as to warrant 

the proposed claims for it; 

(B) its labeling and other material required 

to be submitted comply with the 

requirements of this Act; 

(C) it will perform its intended function 

without unreasonable adverse effects on the 

environment; and 

(D) when used in accordance with 

widespread and commonly recognized 

practice it will not generally cause 

unreasonable adverse effects on the 

environment. 

FIFRA 2(bb) defines ‘‘unreasonable 

adverse effects on the environment’’ as 

(1) any unreasonable risk to man or the 

environment, taking into account the 

economic, social, and environmental costs 

and benefits of the use of any pesticide, or 

(2) a human dietary risk from residues that 

result from a use of a pesticide in or on any 

food inconsistent with the standard under 

section 408 of the Federal Food, Drug, and 

Cosmetic Act. 

The burden to demonstrate that a 

pesticide product satisfies the criteria 

for registration is at all times on the 


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proponents of initial or continued 

registration. (Industrial Union Dept. v. 

American Petroleum Institute, 448 U.S. 

607, 653 n. 61 (1980); Environmental 

Defense Fund v. Environmental 

Protection Agency, 510 F.2d 1292, 1297, 

1302 (D.C. Cir. 1975). 

B. EPA’s Authority for Registration 

Review 

The Food Quality Protection Act 

(FQPA) of 1996 amended FIFRA to add, 

among other things, section 3(g), 

‘‘REGISTRATION REVIEW,’’ as follows: 

(1)(A) GENERAL RULE. - The registrations 

of pesticides are to be periodically reviewed. 

The Administrator shall by regulation 

establish a procedure for accomplishing the 

periodic review of registrations. The goal of 

these regulations shall be a review of a 

pesticide’s registration every 15 years. No 

registration shall be canceled as a result of 

the registration review process unless the 

Administrator follows the procedures and 

substantive requirements of section 6. 

(B) LIMITATION. - Nothing in this 

subsection shall prohibit the Administrator 

from undertaking any other review of a 

pesticide pursuant to this Act. 

(2)(A) DATA. - The Administrator shall use 

the authority in subsection (c)(2)(B) to 

require the submission of data when such 

data are necessary for a registration review. 

(B) DATA SUBMISSION, 

COMPENSATION, AND EXEMPTION. - For 

purposes of this subsection, the provisions of 

subsections (c)(1), (c)(2)(B), and (c)(2)(D) 

shall be utilized for and be applicable to any 

data required for registration review. 

IV. Notice of Proposed Rulemaking 

EPA published proposed procedures 

for the registration review of pesticides 

on July 13, 2005 (70 FR 40251) (FRL–

7718–4). A copy of the proposed rule 

may be found in Docket EPA–HQ–OPP–

2004–0404, which can be accessed 

electronically at: http:// 

www.regulations.gov. The 90–day 

comment period for this proposed rule 

ended on October 11, 2005. 

The preamble to the proposed rule 

discussed: 

• Statutory authority and legislative 

history. 

• The Agency’s goals for the 

registration review program. 

• Evaluating approaches to 

registration review. 

• Factors considered in designing the 

registration review program. 

• Design options considered for the 

registration review program. 

• Testing the proposed registration 

review decision process. 

• Proposed procedures for 

registration review. 

• Relationship of registration review 

to other FIFRA activities. 

• Phase-in of the registration review 

program. 

• Results of reviews required by 

statutes and executive orders. 

V. Overview of Comments 

EPA received 23 comments on the 

proposed rule, as follows: 

• One individual. 

• Two consultants. 

• One public interest group. 

• Four registrants. 

• One State Pesticide Safety 

Coordinator. 

• Three State Lead Agencies for 

pesticides. 

• Five California water sanitation 

agencies. 

• Six trade associations. 

The Agency’s analysis of these 

comments showed that the comments 

can be organized into three broad topic 

areas: 

• Requests for changes in the 

procedural regulations. These comments 

and the Agency’s response are discussed 

in this preamble. 

• Operation and implementation of 

the registration review program. These 

comments and the Agency’s response 

are discussed in this preamble. 

• Issues concerning the licensing of 

pesticides in general are described in 

the response to comments document 

that the Agency has placed in the docket 

for this rulemaking. 

In general, comments on the proposed 

rule resulted in minimal revisions in the 

final rule. Early implementation will 

continue to be discussed with the 

Pesticide Program Dialogue Committee, 

a stakeholder advisory committee 

established under the Federal Advisory 

Committee Act. EPA may issue 

additional guidance on the registration 

review program as it gains experience 

with these procedures. 

VI. Comments on the Procedural 

Regulations 

A. § 155.40--General 

This section describes the purpose of 

the regulations in Subpart C-- 

Registration Review Procedures and 

states that the goal of these procedures 

is a review of each pesticide’s 

registration every 15 years. This section 

also specifies that the regulations apply 

to pesticides registered under section 3 

or section 24(c) of FIFRA, states that the 

Agency may undertake any other review 

under FIFRA at any time and that the 

Agency will use FIFRA section 

3(c)(2)(B) to require new data or 

information that are necessary for a 

pesticide’s registration review. 

1. Authority to establish procedures 

for registration review. A trade 

association questioned EPA’s authority 

to establish the proposed procedures for 

registration review. They asserted that 

in the absence of specific procedures in 

FIFRA for the administration of 

registration review, EPA must use 

procedures in FIFRA section 3(c)(8) 

which specifies procedures for 

conducting interim administrative 

review to develop a risk-benefit 

evaluation of a pesticide. Procedures for 

implementing FIFRA section 3(c)(8) are 

described in 40 CFR part 154. 

The Agency does not agree with this 

comment. FIFRA section 3(g)(1)(A), 

which mandates a periodic review of 

the registration of pesticides, requires 

the Agency to establish procedures for 

conducting such reviews. This 

provision means that, except for 

limitations specified in FIFRA section 

3(g)(1)(B) and FIFRA 3(g)(2), EPA has 

the authority to develop procedures for 

the conduct of this new program. 

Accordingly, EPA is not required to use 

procedures in FIFRA section 3(c)(8) to 

conduct the review mandated in FIFRA 

section 3(g). 

2. Registration review of pesticides 

covered under FIFRA section 25(b). An 

industry comment asked EPA to assure 

that products exempted from FIFRA 

regulation under section 25(b) of FIFRA 

are reviewed adequately, especially 

with regards to health claims. 

Pesticides that are exempt from 

FIFRA requirements under FIFRA 

section 25(b) are identified in 40 CFR 

152.20, Exemptions for pesticides 

regulated by another Federal agency, 

and 40 CFR 152.25, Exemptions for 

pesticides of a character not requiring 

FIFRA regulation. Pesticides covered by 

FIFRA section 25(b) are not subject to 

registration review. However, some 

products that are exempt under FIFRA 

section 25(b) could be affected by 

actions taken in registration review. For 

example, pesticide-treated articles or 

substances described in § 152.25(a) 

could be affected if issues arise during 

the registration review of a pesticide 

used to treat an article or substance. If 

the pesticide product or its use on 

treated articles or substances were 

canceled, the treated article or substance 

would no longer meet the requirements 

of § 152.25(a), which specifies that the 

pesticide used to treat an article or 

substance must be registered for that 

use. 

B. § 155.42--Baseline Dates for 

Registration Review Cases 

In § 155.42(d), EPA proposed to 

establish a baseline date for each 

registration review case. In general, the 

baseline date would be the date of 

initial registration of the oldest product 

in the registration review case or the 

date of reregistration, whichever is later. 


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The date of reregistration would be the 

date on which either a Reregistration 

Eligibility Decision (RED) or an Interim 

Reregistration Eligibility Decision 

(IRED) was signed, whichever date the 

Agency determines to be most 

appropriate. 

An industry comment suggested that 

to avoid duplication of effort, the 

Agency should amend § 155.42 to use 

the date of approval of significant new 

uses as the baseline date for the 

registration review case. 

The Agency intended the baseline 

date to be the date of the last 

comprehensive review. A review of a 

new use may not be comprehensive-- 

previously approved uses may not be 

included in the evaluation of the new 

use. Generally, when conducting a 

registration review of a pesticide for 

which a significant new use was 

recently approved, EPA would not redo 

the recent review but would incorporate 

the risk assessment for the new use into 

the registration review. 

Another commenter asserted that 

baseline dates should be either the 

initial registration of a pesticide or the 

completion of the RED. The commenter 

stated that the IRED should not be used 

because it does not include an 

assessment of cumulative risk that is 

required for pesticides that have a 

common mechanism of toxicity with 

other substances. For such pesticides, 

the Agency should use the date of the 

RED (as opposed to IRED) to establish a 

common baseline date for all the 

pesticides included in the cumulative 

risk assessment. 

The Agency agrees that the RED 

would update the comprehensive IRED 

regarding cumulative risk or other 

issues but the RED itself may not be a 

comprehensive review. For cases where 

there is both an IRED and a RED, the 

Agency needs the flexibility to decide 

which document represents a 

comprehensive review. Accordingly, 

this final rule allows the Agency to use 

the date of either document as the 

baseline date. 

C. § 155.44--Establishing and 

Announcing Schedules for Registration 

Review 

1. Chronological vs. risk-based criteria 

as basis for establishing schedules for 

registration review. In § 155.44, EPA 

proposed that schedules would be based 

on the baseline date of the registration 

review case or on the date of the last 

registration review of the registration 

review case. The rule allows the Agency 

to take into account other factors, such 

as achieving process efficiencies, when 

setting schedules. The preamble of the 

proposal described other factors that the 

Agency might consider. In July 2006, 

EPA released draft schedules that were 

developed using procedures in the 

proposed rule. Under the draft 

schedules, EPA would review 

chemically related registration review 

cases together. 

While most commenters supported 

the proposed chronological approach, 

public interest groups and water 

treatment authorities advocated riskbased approaches for scheduling. 

Several industry groups did not like the 

chemical groupings in the Agency’s 

draft schedules, preferring that cases be 

scheduled for registration review in a 

strictly chronological order. They 

argued that grouping cases together 

undermines the chronological order of 

the schedule and that the order of 

groups in the schedule would be based 

on risk concerns. One industry group 

asked the Agency to include in the rule 

criteria for deviating from a 

chronologically based schedule and to 

consult registrants regarding the 

selection of new dates. 

While the Agency appreciates that 

there is a range of views as to how to 

set schedules for the registration review 

program, the establishment of schedules 

is within the Agency’s discretion. EPA 

believes that reviewing similar cases 

together facilitates decision making for 

pesticides with similar scientific or 

regulatory issues and would be an 

efficient use of resources. Registrants or 

other stakeholders may notify the 

Agency regarding particular issues that 

could impact the schedule. The Agency 

would consider such issues as 

appropriate. 

2. Considerations that could change 

the registration review schedule. The 

Agency may consider factors other than 

the baseline date of the registration 

review case when developing schedules 

for registration review. As discussed in 

Unit IX.E. of the preamble of the 

proposed rule and as shown on the draft 

schedule released in July 2005, the 

Agency plans to cluster identified cases 

belonging to the same chemical class or 

group to promote efficiency of review 

for the Agency and provide a ‘‘level 

playing field’’ for industry. 

Additionally, because the Agency’s 

economic analysis of this regulation 

suggested that a small business (i.e., a 

business that meets criteria established 

by the Small Business Administration) 

might face high data generation costs if 

it holds registrations in two or more 

registration review cases that are 

scheduled to undergo registration 

review in the same year, the Agency 

may schedule these cases out of 

chronological order. 

The Agency has a continuing 

obligation to respond to emerging risk 

concerns (discussed in Unit XI.B. of the 

preamble of the proposed rule). At any 

time, the Agency may receive new 

information that suggests that the 

Agency should reevaluate a previous 

decision to register a pesticide. After the 

registration review program begins, the 

Agency will continue to address 

emerging risk concerns. If a pesticide 

presents an urgent potential risk of 

concern, the Agency may opt to review 

all other aspects of the pesticide’s 

registration at that time, rather than only 

looking at the risk of concern. In such 

cases, the Agency may update the 

registration review schedule by 

announcing the new date of the 

registration review of this case. 

In general, the Agency may consider 

these and other factors, including issues 

raised by the public or the registrant 

when reviewing a posted schedule, to 

schedule a pesticide registration review, 

or to modify the schedule of a pesticide 

registration review as appropriate. 

3. Three-year schedules. Although the 

preamble of the proposed rule 

contemplated maintaining a 3–year 

schedule, the proposed rule did not 

specify a timeframe. In response to 

comments requesting this change, the 

Agency has modified § 155.44 to specify 

that the schedules would cover the 

current year and at least two subsequent 

years. 

D. § 155.46--Deciding that a Registration 

Review is Complete and Additional 

Review is Not Needed 

Under § 155.46, the Agency may 

propose that no additional review of a 

pesticide is needed in order to 

determine whether the pesticide 

continues to meet FIFRA requirements 

for registration. The Agency would 

announce the availability of such 

proposals and take comment on them. 

In response to comments on a proposal 

made under § 155.46, EPA may 

reconsider its proposal and schedule a 

registration review of the pesticide. 

The Agency received one comment 

asking the Agency to clarify the purpose 

of this provision. The purpose of this 

provision is to give the Agency 

flexibility to not schedule a pesticide for 

registration review if the pesticide has 

such low toxicity, exposure or risk that 

another review would not change the 

Agency’s position and would not be an 

effective use of resources. The Agency 

may also use this provision for a 

pesticide that has recently undergone a 

comprehensive review. In proposed 

decisions issued under § 155.46, the 

Agency generally would explain why it 

believes that no additional review is 


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necessary and reference, as appropriate, 

publicly available documentation to 

support the Agency’s position. 

To clarify the procedures it will use 

in § 155.46, EPA is modifying the 

second sentence to read, ‘‘In such cases, 

instead of establishing a pesticide 

registration review case docket as 

described in § 155.50, the Agency may 

propose that, based on its determination 

that a pesticide meets the FIFRA 

standard for registration, no further 

review will be necessary.’’ EPA is 

clarifying the status of pesticides subject 

to this section by adding the sentence, 

‘‘The date of the final notice of 

availability would be used as the date of 

the latest registration review for the 

purpose of scheduling subsequent 

registration reviews.’’

E. § 155.48--Data Call-In 

Section 155.48 provides that, as 

required by FIFRA section 3(g), EPA 

will use procedures in FIFRA section 

3(c)(2)(B) to require submission of data 

that are needed to conduct a pesticide’s 

registration review. This paragraph 

stipulates that the data protection 

provisions of FIFRA 3(c)(1), (c)(2)(B), 

and (c)(2)(D) apply to the submission, 

compensation and exemption of data 

required to conduct a registration 

review. 

1. Data Call-In procedures. One 

comment asked why the proposed rule 

does not impose any requirements 

under FIFRA 3(c)(2)(B). The commenter 

suggested that additional data collection 

authorities are needed and procedures 

to ensure all necessary data must be 

included in this rule. 

The Agency finds that it is not 

necessary to develop new procedures 

for calling in data for registration review 

because FIFRA section 3(g) requires the 

Agency to use section 3(c)(2)(B) to 

collect the data, and that section 

provides EPA with sufficient authority 

to obtain any necessary data. 

2. Data compensation for 

‘‘voluntarily’’ submitted data. Industry 

comments asked that the proposed rule 

clarify the data compensation status of 

information voluntarily submitted in 

response to registration review. Some 

comments suggested that the rule 

specify the mechanisms for requesting 

and obtaining a Data Call-In notice (DCI) 

before the data are submitted in order to 

protect data compensation rights. Other 

comments suggested that studies used 

in the registration review decision, 

particularly studies generated under 

revisions to the data requirements in 40 

CFR part 158, be presented in the 

decision document. Registrants asked 

that in addition to determining whether 

a pesticide meets the FIFRA risk/benefit 

standard, EPA should assure that the 

registrant of the pesticide is entitled to 

use data supporting the risk/benefit 

determination for the pesticide. 

The Agency acknowledges the 

importance of this issue and agrees that 

this concern should be addressed in the 

conduct of the registration review 

program. FIFRA section 3(g)(2)(A) 

directs the Agency to utilize section 

3(c)(2)(B) to require the submission of 

data when such data are necessary for 

a registration review. Similarly, FIFRA 

section 3(g) requires that the data 

compensation provisions, including 

those set forth in sections 3(c)(1), 

3(c)(2)(B), and 3(c)(2)(D) ‘‘be utilized for 

and applicable to any data required for 

registration review.’’ Hence, to the 

extent the Agency requires any data for 

registration review, such data are 

eligible for the data protections 

provided by the statute. 

If a company submits data or 

information to the docket voluntarily (as 

opposed to providing these data or 

information in response to a DCI), such 

data are not ‘‘required’’ data eligible for 

protection under the statute. However, 

the Agency may evaluate these data or 

information and find that it must rely on 

this information to support the 

continued registration of pesticide 

products. If the Agency makes such a 

finding in the course of a pesticide’s 

registration review, this finding would 

be a determination that the voluntarily 

submitted data or information are now 

required. This would be a ‘‘compensable 

event’’ and would trigger the 

requirement for compensation to be 

addressed. The competitors to the 

original submitter would be required to 

submit their own data or offer data 

compensation to the data submitter for 

use of the study. A ‘‘compensable 

event’’ would also arise should the 

Agency issue a Data Call-In Notice for 

the same data as were previously 

submitted voluntarily, but a Data CallIn Notice is not necessary to trigger 

compensability should the Agency 

determine and announce as part of its 

registration review decision that the 

particular data were required to support 

the registrations in question. 

The Agency’s registration review 

decision document may identify such 

data or information and the registration 

review decision document may 

establish a deadline for registrants 

whose registrations depend on such 

data to offer compensation to the 

owners of the data or submit their own 

data. The Agency may cancel the 

product registration of registrants who 

fail to adequately support a registration. 

F. § 155.50--Initiate a Pesticide’s 

Registration Review 

EPA proposed to establish a docket 

for each registration review case, except 

for cases covered under § 155.46. The 

docket would describe information that 

the Agency may consider in the course 

of a pesticide’s registration review and 

describe information that the Agency 

does not have that might be useful in 

the review. The public would be invited 

to review information in the docket and 

submit, within 60 days, any other 

information that they believe should be 

considered in the pesticide’s review. A 

pesticide’s registration review begins 

when EPA opens the docket for 

registration review case. 

1. Timeframe for submitting 

comments. As originally proposed, the 

timeframe for submitting comments in 

response to a notice issued under 

§ 155.50(b) would be ‘‘60 calendar 

days.’’ In response to comments that 

this time frame would not be long 

enough, the Agency is modifying this 

paragraph to specify that the time frame 

for such comment periods will be ‘‘at 

least 60 calendar days.’’

2. Late submissions. Comments from 

industry and others asked the Agency to 

clarify its position regarding data or 

information submitted after the due date 

established in the notice announcing the 

opening of the pesticide registration 

review case docket. 

Under § 155.50(c)(1), the Agency will 

consider late submissions if the Agency 

believes that the new data or 

information are critical for the 

regulatory decision, such as health 

effects or ecological effects data or 

exposure data that the EPA could use to 

refine a risk assessment. 

If a person has data or information 

that he/she believes that Agency should 

consider during the pesticide’s 

registration review, but the data or 

information will not become available 

before the expiration of the comment 

period, he/she may either request an 

extension of the comment period, or in 

accordance with § 155.52, consult with 

the Agency regarding a submission date 

for these materials. 

3. Information submitted under 

§ 155.50(c). Comments from industry 

asked the Agency to modify § 155.50(c) 

to specify the types of information that 

might be submitted under this 

paragraph and to reference quality and 

scientific criteria for data that might be 

submitted as comments during a 

pesticide’s registration review. 

In the preamble of the proposed rule, 

EPA described the kinds of information 

that, based on its experience in the 

pesticide reregistration program, might 


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be useful in registration review. As the 

Agency and its stakeholders gain 

experience in the registration review 

process, it may become clear what types 

of information are most useful. EPA 

could then develop appropriate 

guidance. In accordance with the Data 

Quality Act, EPA has already issued 

guidance regarding the quality of 

information that it relies upon for 

regulatory decisions. This guidance is 

available at EPA’s website at: http:// 

www.epa.gov/quality/ 

informationguidelines/. The Agency 

will use this guidance in the registration 

review of pesticides. 

G. § 155.52--Stakeholder Engagement 

Under § 155.52, the Agency may meet 

with registrants or other stakeholders 

during a pesticide’s registration review 

or to prepare for a forthcoming review. 

This section explains the procedure for 

releasing minutes or other material 

relating to such meetings. 

Comments from industry asked that 

the rule provide an acceptable 

framework for activities in the preinitiation stage. Other commenters 

remarked that non-registrants should 

have more access to the registration 

review process and that the public 

should be able to view all information, 

including reports from consumers about 

adverse effects. Additionally, they 

asserted that EPA should announce 

consultation opportunities in the 

Federal Register. Other comments from 

industry emphasized their concern that 

EPA not release confidential business 

information. 

In this document, the Agency is 

establishing procedures that provide the 

public with the opportunity to 

participate in the review process and to 

review materials that the Agency uses as 

the basis of proposed registration review 

decisions. 

The Agency generally does not 

announce in the Federal Register 

meetings with registrants or other 

stakeholders because it needs the 

flexibility to hold such meetings when 

the need arises. EPA may meet privately 

with industry to discuss proprietary or 

other confidential business information. 

Under § 155.52(a) and (b), EPA will 

place in the docket minutes of meetings 

with registrants or other stakeholders. 

EPA’s protection of information claimed 

to be confidential business information 

is governed by section 10 of FIFRA and 

the Agency’s regulations in 40 CFR part 

2. 

H. § 155.53--Conduct of a Pesticide’s 

Registration Review 

This section describes how the 

Agency will assess the significance of 

changes in statutes and regulations, risk 

assessment procedures or methods, or 

data requirements and any new 

information about the pesticide to 

determine whether additional review of 

the pesticide is warranted. If a new 

review of the pesticide active 

ingredients or individual products in a 

registration review case is needed, the 

Agency will determine whether 

additional information is necessary to 

conduct the review. This section also 

provides for public review and 

comment during the review process. 

Under the proposed procedures, the 

Agency would generally establish 

comment periods of ‘‘at least 60 

calendar days,’’ except in § 155.53(c) 

where the comment period is ‘‘at least 

30 calendar days.’’

1. Agency’s approach for conducting 

registration review. The Agency 

received several comments that 

disagreed with the Agency’s proposed 

approach for conducting a pesticide’s 

registration review. An industry trade 

association reiterated comments made 

in response to the April 2000 Advance 

Notice of Proposed Rulemaking (65 FR 

24585, April 26, 2000) (FRL–6488–9) 

that the Agency should use a checklist 

or decision tree for deciding whether a 

pesticide continues to meet the 

requirements for registration. Other 

stakeholders expressed concern that the 

proposed approach was not sufficiently 

rigorous and would lead to relaxed 

standards. 

In the preamble of the proposed rule, 

the Agency described alternative 

approaches for conducting a pesticide’s 

registration review and explained why it 

selected the proposed approach. The 

comments do not raise issues or 

concerns that would alter EPA’s choice 

of approach. It is important to note, 

however, that although the Agency has 

not chosen to use a pure checklist 

approach, it is using a decision 

paradigm that ensures that the process 

will be transparent while still providing 

sufficient flexibility to allow for the 

scope and depth of a particular review 

to be tailored to the circumstances of the 

particular registration review case. 

2. Review of individual product 

registrations. Some registrants expressed 

their belief that the Agency should 

conduct a comprehensive review of 

individual product registrations to 

assure adequacy of product labels, 

product-specific data, and any claims 

for generic data exemption under FIFRA 

section 3(c)(2)(D). 

As explained in the preamble of the 

proposed rule, during the comment 

period on the initial registration review 

case docket, the public may comment 

on the need for a new review of 

individual product registrations. The 

Agency will continue to comply with its 

data protection obligations under FIFRA 

section 3(c)(2)(D). 

3. Public participation procedures. 

Several commenters noted that under 

the Agency’s procedures for public 

participation in the reregistration and 

tolerance reassessment programs, the 

Agency may announce the availability 

of a revised risk assessment and may 

invite the public to suggest approaches 

for mitigating the risks identified in the 

revised risk assessment. The proposed 

procedures for registration review did 

not provide this opportunity. 

In response to this comment, the 

Agency is revising § 155.53(c) so that it 

may provide the public an opportunity 

to comment on possible risk mitigation 

when a revised risk assessment shows 

risks of concern. However, if immediate 

action is warranted, the Agency may 

initiate cancellation or suspension 

procedures under FIFRA section 6. In 

this event, the Agency would not 

provide the opportunities for public 

comment described in § 155.53(c) but 

would follow procedures in FIFRA 

section 6, as appropriate. 

4. Length of comment periods. Several 

commenters asserted that the comment 

periods provided in the proposed 

regulation were not long enough. 

Generally, where EPA publishes a 

document for comment, the Agency 

considers requests for extension if a 

reasonable basis for extension is 

provided. It is not necessary to modify 

these regulations to provide for 

extending comment periods. 

I. § 155.57--Registration Review Decision 

This section states that a registration 

review decision is the Agency’s 

determination whether a pesticide 

meets, or does not meet, the standard for 

registration under FIFRA. 

1. Goal of registration review. The 

California Stormwater Quality 

Association asserted that the goal of 

registration review should be to protect 

water quality and minimize the need to 

mitigate pesticide impacts through 

Clean Water Act (CWA) mechanisms. 

The Agency believes that the goal of 

registration review is set forth in FIFRA 

section 3(g) and reiterated in § 155.40. 

Registration review is a determination 

whether a pesticide continues to meet 

the FIFRA standard for registration, 

including, among other things, that the 

pesticide does not cause unreasonable 

effects on the environment. As part of 

this review, EPA will assess the effects 

of pesticides on water quality. However, 

while meeting CWA standards is 

important, it is not the only goal of 

registration review. 


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2. FIFRA standard for registration. (a) 

Comments from industry strongly 

oppose EPA’s intention to consider a 

pesticide’s benefits during registration 

review. The comments referred to a 

discussion in the preamble of the 

proposed rule where EPA explained that 

it would evaluate information about the 

benefits of a pesticide with known high 

risks during registration review if a new 

and safer alternative to a pesticide has 

become available. The comments 

asserted that it is inappropriate for the 

Agency to base continued registration of 

a pesticide on a comparative benefits 

assessment with other pesticides. The 

comments cited FIFRA section 3(c)(5) to 

support their assertion that when 

pesticides meet the registration criteria 

of FIFRA, the Agency should not be 

allowed to make marketplace decisions 

of one product over another. FIFRA 

section 3(c)(5) states, ‘‘The 

Administrator shall not make any lack 

of essentiality a criterion for denying 

registration of any pesticide. Where two 

pesticides meet the requirement of this 

paragraph, one should not be registered 

in preference to the other.’’

EPA believes the commenter 

misapprehends the nature of FIFRA’s 

risk-benefit balancing standard. A 

determination that a pesticide meets the 

registration standard under FIFRA at 

one time does not necessarily mean that 

the same pesticide will meet the 

standard at all times in the future, even 

if the science associated with the risks 

posed by the pesticide does not change. 

Significant changes in the benefits 

picture, such as the development of pest 

resistance or new alternatives, can also 

affect whether a pesticide continues to 

meet the FIFRA registration standard. 

EPA does not intend to compare 

benefits of two or more pesticides that 

do not pose risks of concern. As the 

commenters noted, EPA may not make 

a determination of essentiality when 

two pesticides meet the FIFRA 

requirements for registration. However, 

when there are risks of concern for a 

pesticide, FIFRA requires EPA to weigh 

those risks against the benefits of that 

pesticide to determine whether the risks 

are unreasonable. Benefits are the 

advantages that accrue to the pesticide 

users or society in general, such as 

increased production, decreased 

production costs, pest-free homes, or 

disease-vector control. The magnitude 

of those benefits often depends on the 

availability of alternative pest control 

measures, whether chemical, biological 

or cultural. Benefits are, in general, 

expected to be higher when there are no 

viable alternatives. 

During registration review, EPA may 

reassess a pesticide that has remained 

registered even though high risks are 

associated with the use of the pesticide. 

In its earlier review, the Agency may 

have found that the pesticide did not 

pose unreasonable risk because of the 

high benefits of the pesticide. In 

registration review, EPA may find that 

existing risk assessments that identify 

these risks of concern are still valid. 

EPA would then determine whether the 

pesticide continues to provide sufficient 

benefits to justify maintaining the 

registration. The benefits finding could 

depend on whether new, safer 

alternatives have been registered since 

EPA’s earlier decision. EPA conducted 

similar analyses in the reregistration 

program. 

If EPA’s review of a pesticide’s 

registration appears to show that the 

pesticide does not meet the FIFRA 

standard for registration, EPA would 

follow procedures in FIFRA section 6 to 

change, cancel or suspend the 

pesticide’s registration. This section sets 

out where it requires EPA to assess the 

benefits of the pesticide and provides 

opportunities for public hearings on 

whether the pesticide’s registration 

should be changed, canceled, or 

suspended. The Agency would not 

analyze benefits when a registrant 

responds to the Agency’s registration 

review finding by agreeing to the 

cancellation of a pesticide or 

termination of one or more of its uses 

under FIFRA section 6(f). However, 

FIFRA provides the public an 

opportunity to comment on the 

proposed action. 

(b) Another registrant asserted that the 

registration review regulations should 

contain language that specifically 

reaffirms the standard of imminent 

hazard and substantial risk as the basis 

for cancelling pesticide registrations. He 

cited a specific product example to 

illustrate his belief that the Agency 

employed a ‘‘zero tolerance agenda’’

during reregistration. 

The standard of ‘‘imminent hazard’’

referred to by the commenter applies to 

suspensions and emergency 

suspensions under FIFRA section 6(c). 

This section sets forth the standard for 

a suspension or an emergency 

suspension. This is not the standard that 

the Agency will use in making 

registration review decisions. The 

Agency interprets registration review to 

be a determination that a pesticide 

continues to meet the standard for 

registration in FIFRA section 3(c)(5), or, 

where appropriate, section 3(c)(7). This 

standard specifies, among other things, 

that a pesticide may not pose 

unreasonable risk to man or the 

environment. 

When a pesticide poses risks of 

concern to humans or the environment, 

the Agency must address these risks. 

The options for addressing such risks 

include risk mitigation, determining 

that the risks are justified in light of the 

benefits of the pesticide, or initiating 

regulatory options to modify or cancel 

the registration. EPA generally consults 

with registrants and other stakeholders 

when deciding how to mitigate a risk. In 

addition, EPA has modified the 

proposed public participation 

procedures for registration review to 

generally add a public comment period 

when a pesticide poses risks of concerns 

so members of the public can provide 

suggestions for reducing the risk. This 

procedure provides registrants and other 

stakeholders an opportunity to provide 

input on the Agency’s risk management 

decisions. 

J. § 155.58--Procedures for Issuing a 

Decision on a Registration Review Case 

In this section, EPA explains that it 

will issue proposed registration review 

decision documents for public review 

and comment. In comments on the 

proposed rule, various stakeholders 

advised the Agency of their expectations 

and needs regarding the documentation 

of registration review decisions and 

suggested how this documentation 

might be presented. EPA appreciates 

these suggestions. The Agency has 

consulted the Pesticide Program 

Dialogue Committee and has considered 

their recommendations together with 

comments submitted on the proposed 

procedural regulations. Nothing in the 

comments indicates the need to modify 

the regulation to specify the format of 

the registration decision document. 

VII. Comments on the Operation of the 

Registration Review Program 

A. Scope of the Registration Review 

Program 

1. Is registration review a safety net? 

In the preamble of the proposed rule, 

the Agency described how it intended to 

use registration review as the framework 

for managing the regulatory status of 

existing pesticides. 

Industry trade associations did not 

agree with this approach. In their 

comments, they asserted that EPA 

should not expand registration review 

beyond the intent of Congress because 

to do so risks repeating the Agency’s 

experience with reregistration which 

began as a 5–year program in 1972 and 

still has not been completed. They 

asserted that registration review should 

not be a catch-all for other programs and 

actions. For example, special review, 

actions under FIFRA section 3(c)(8), 


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FIFRA section 6 or the Pesticide 

Registration Improvement Act (PRIA) 

should not be included in the 

registration review program. They 

believe that new programs such as 

endocrine disruptor screening and 

testing should be conducted 

independently of registration review. 

The industry comments advocate that, 

as far as possible, registration review 

should be a safety net. 

EPA does agree that registration 

review is not the only mechanism for 

addressing pesticide registration issues, 

and will continue to use other 

provisions of FIFRA to address 

particular registration issues. However, 

EPA does not agree with the comment 

that registration review should function 

solely as a safety net to discover and 

resolve issues missed or overlooked in 

registration, tolerance reassessment, or 

reregistration activities. While EPA 

expects that it will occasionally 

discover issues that were overlooked in 

previous reviews, the purpose of 

registration review is to consider the 

pesticide in light of new knowledge that 

was not available for previous reviews. 

EPA interprets the Congressional 

mandate for registration review to be a 

periodic assessment whether a pesticide 

continues to meet the FIFRA standard 

for registration in light of new 

knowledge. Therefore, the scope of a 

pesticide’s registration review includes 

all aspects of a pesticide’s registration 

specified in section 3(c)(5) of FIFRA 

with respect to product composition, 

labeling and other required material, 

and risks and benefits. Registration of 

new pesticides or new uses of pesticides 

under PRIA is a separate program from 

registration review. However, in 

evaluating a new use under PRIA, the 

Agency would consider all relevant 

information, including information that 

it might consider during the pesticide’s 

registration review. 

2. Incorporating evolving or new 

programs into registration review. As 

explained in the preamble of the 

proposed rule, EPA intends to 

incorporate new requirements, such as 

endocrine disruptor screening and 

testing or endangered species 

assessments into the registration review 

program as these aspects of risk 

assessment mature into routine 

evaluations for pesticides. 

Industry commenters advised the 

Agency to avoid using registration 

review as the sole process for handling 

new issues. They asserted that attaching 

all these assessments (endangered 

species assessments, endocrine 

disruptor screening and testing, review 

of substitutes, etc.) to a program 

intended to accomplish periodic review 

of all pesticides will undermine the 

timeliness of the review process for a 

great many pesticides. Commenters 

believe that this may result in an everchanging schedule that will deprive 

registrants and users of predictability 

and lead to significant inefficiencies 

within the Agency. 

Again, EPA does not intend to use 

registration review as the only 

mechanism for addressing pesticide 

registration issues. However, EPA 

believes it is appropriate to use 

registration review as the framework for 

managing its responsibilities regarding 

existing pesticides. In making a FIFRA 

section 3(c)(5) decision as required 

under FIFRA section 3(g), EPA must 

consider all information that pertains to 

that decision. EPA regards endangered 

species assessments required under the 

Endangered Species Act or endocrine 

disruptor screening and testing required 

under the Federal Food, Drug, and 

Cosmetic Act as part of the risk 

characterization of the pesticide that is 

intrinsic to the FIFRA risk/benefit 

decision. If knowledge exists on these or 

other scientific issues at the time of a 

pesticide’s registration review, the 

Agency believes it must consider them 

when it makes its FIFRA (3)(c)(5) 

finding. 

3. Managing emerging issues. In the 

preamble of the proposed rule, the 

Agency explained that it will continue 

to give priority to emerging risk 

concerns. While reviewing the new risk 

concern, the Agency may find that it 

would be more efficient to review all 

other aspects of the pesticide’s 

registration at the same time. The 

procedural regulations for registration 

review provide flexibility to amend the 

schedule to advance the registration 

review of a pesticide in this 

circumstance. The Agency would 

provide as much advance notice as 

possible regarding such changes in the 

schedule. 

Commenters took exception to EPA’s 

approach for managing emerging issues 

arguing that newly discovered risks of 

potential concern should be dealt with 

outside of registration review if the risks 

are urgent. The commenters believe that 

registration reviews should not be 

rescheduled under this circumstance. 

The Agency does not agree that it 

should reassess the approach described 

in the preamble of the proposed rule. 

EPA fully explained its reasoning in the 

proposed rule and the comments do not 

persuade it otherwise. This is not to say 

that the Agency will not address urgent 

risks of concern outside the registration 

review process if the Agency determines 

that to be the appropriate course of 

action. 

4. Assessing risks of substitute 

pesticides. In the preamble of the 

proposed rule, EPA explained that it 

might advance the registration review of 

pesticides that are potential substitutes 

for a pesticide or some uses of the 

pesticide that are being canceled under 

FIFRA section 6 because of risk 

concerns. 

Industry commenters expressed 

concern that EPA would even consider 

using the registration review program to 

address reviews that might be the 

outgrowth of cancellation proceedings. 

EPA generally would assess risks of 

substitute pesticides as part of the 

cancellation process in FIFRA section 6. 

In the rare event that it is necessary to 

perform a comprehensive review of a 

substitute pesticide, such a review 

might be tantamount to conducting the 

registration review of that pesticide. In 

such cases, EPA might find that it 

would be more efficient to conduct the 

registration review of the pesticide at 

the same time. 

5. Review of inert ingredients. In the 

preamble of the proposed rule, EPA 

explained that it would handle inert 

ingredients in a process that is separate 

from registration review. 

Some commenters agree with EPA’s 

approach of dealing with inert 

ingredients. However, others question 

the need to review inert ingredients at 

all. A public interest group expressed 

concern that having separate review 

processes for active ingredients and 

inert ingredients could result in missing 

or ignoring synergistic effects of 

mixtures of ingredients. 

The Agency intends to follow the 

procedures outlined in the preamble of 

the proposed rule. The Agency 

recognizes that there may be 

interactions among the various 

chemicals in pesticide products. 

Currently, the Agency requires acute 

toxicity data for end-use products, i.e., 

formulations containing active and inert 

ingredients. These studies address, 

albeit to a limited extent, potential 

synergistic effects of mixtures of active 

and inert ingredients in a pesticide 

product. However, to test and review all 

of the potential combinations of 

ingredients would require significant 

resources. The Agency will consider 

new scientific methodologies to identify 

potential interactions among chemicals, 

should they become available. 

B. Data and Information Collection in 

the Registration Review Program 

In the preamble of the proposed rule, 

the Agency described strategies for 

acquiring information to support a 

pesticide’s registration review including 

issuing Data Call-In notices to require 


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data necessary to conduct a review and 

searching the published literature for 

pertinent information about a pesticide. 

The Agency explained that early 

acquisition of data or information that 

could be useful in refining a pesticide’s 

risk assessment would reduce the time 

and effort needed to complete the 

review of a pesticide. As explained in 

the preamble, EPA might be able to 

identify data or information needs when 

it publishes the schedule for a 

pesticide’s registration review. In some 

cases, data or information needs might 

become apparent when the Agency 

assembles the initial docket for the 

registration review case. In this event, 

the docket for the registration review 

case would identify data or information 

needs. In other cases, the Agency might 

not be able to identify data or 

information needs until it evaluates the 

information in the initial docket. 

1. Identification of information that 

may be used to refine risk assessments. 

An industry trade group acknowledged 

EPA’s concern about redoing risk 

assessments when, in response to a 

preliminary risk assessment, a registrant 

or other stakeholder submits new data 

or information to refine the preliminary 

risk assessment. However, they believe 

that such iteration is inevitable. When 

registrants conduct their own risk 

assessments, they may use different 

assumptions or interpretations of data 

than the Agency uses in its risk 

assessments. When the Agency’s risk 

assessment shows higher risks than the 

registrants found in their own 

assessments, they must either develop 

data or information to refine the risk 

assessment or cancel uses. 

EPA agrees that some iteration may be 

inevitable. However, the Agency 

publishes its risk assessment methods, 

including its approach for interpreting 

data. So it may be possible for 

registrants to anticipate the Agency’s 

information or data needs in a 

forthcoming registration review and to 

reduce the degree of iteration in the risk 

assessment process. 

2. Information developed under the 

Clean Water Act. In public discussions 

about the proposed rule, EPA received 

a suggestion from water treatment 

authorities that the Agency might 

consider information developed under 

section 303(d) of the Clean Water Act, 

which identifies impaired water bodies. 

In comments, States raised the 

concern that they do not have the 

resources to assemble such data. 

Registrants expressed their concern that 

these data not be taken at face value 

because the criteria and process used to 

develop these data might affect the 

reliability of this information. 

EPA believes that information on 

water quality may be useful in 

registration review and will make efforts 

to obtain State data for CWA section 

303(d) listings due to pesticides. When 

evaluating such data, EPA will take into 

account the procedures used to develop 

the data to assess the quality and 

usefulness of the data. 

C. Work-Sharing 

The preamble of the proposed rule 

described the Agency’s intention to 

develop work-sharing agreements with 

its partners in the Organization for 

Economic Cooperation and 

Development (OECD) or the North 

American Free Trade Agreement 

(NAFTA). In comments on the proposed 

rule, industry trade associations 

expressed concern that conducting 

reviews jointly with EPA’s NAFTA or 

OECD partners might cause delays. 

EPA continues to believe that 

harmonization and work-sharing will 

result in process efficiencies and 

superior decisions. Since EPA’s partners 

also have programs for reassessing 

pesticides, all parties could benefit by 

coordinating their efforts. EPA and its 

Canadian counterpart have begun 

discussions for work-sharing during 

registration review with the expectation 

that they will develop a work-sharing 

plan by the December 2006 meeting of 

the NAFTA Technical Working Group 

on Pesticides. 

EPA gave a presentation on the 

registration review program at the 

February 2006 meeting of the OECD 

Working Group on Pesticides. EPA 

intends to continue encouraging the 

OECD community to participate in 

work-sharing efforts. 

EPA may adjust its schedule slightly 

to take advantage of these potential 

opportunities for work-sharing. 

D. Adequacy of EPA’s Methods for 

Assessing Potential Risk to Water 

Quality 

California water-treatment authorities 

questioned the adequacy of EPA’s 

assessment of risks with regard to water 

quality considerations including: Use of 

aquatic toxicity testing, surface water 

quality studies, and urban uses of 

pesticides, particularly when these uses 

result in pesticide residues in receiving 

waters for storm sewers or sewage 

treatment plants. The commenters 

reported that in some cases, pesticide 

residues in water released by a sewage 

treatment plant may exceed its NPDES 

permit, which would be a violation of 

the Clean Water Act. They also noted 

that residues from agricultural uses of 

pesticides, e.g., rice pesticides and 

pesticide degradates have been found in 

drinking water supplies. 

The Office of Pesticide Programs 

(OPP) will manage water-related issues 

within the framework of the registration 

review of pesticides. OPP expects that 

its capacity for characterizing risk will 

continue to improve as it works with the 

Office of Water to refine its models for 

estimating exposures and as more 

monitoring data become available. 

E. Achieving Label Improvement 

through the Registration Review 

Program 

Several commenters see the 

registration review program as an 

opportunity to improve the quality of 

labels on individual pesticide products. 

One aspect of label improvement would 

be to minimize the number of different 

labels for the same product. According 

to comments, this situation arises 

because many States require State 

registration and impose their own 

labeling requirements. 

The Agency is committed to 

improving the consistency of labels. 

EPA already works with States on 

labeling issues. However, the Agency 

notes that section 24(b) of FIFRA 

prohibits States from establishing or 

maintaining labeling requirements. The 

Agency agrees that label improvement is 

a worthwhile goal for the registration 

review program. 

VIII. Implementation Issues 

A. Coordination of the Registration 

Review Rule with the Data Requirements 

Rule 

Industry comments asserted that EPA 

should delay implementing registration 

review until the recently proposed 

revisions to the data requirements in 40 

CFR part 158 have been finalized. They 

stated their belief that EPA cannot make 

registration review decisions until it has 

completed revising the data 

requirements for the registration of 

pesticides. Industry is concerned that if 

registration review is initiated before a 

final rule on data requirements, 

different standards will apply to cases 

reviewed early in the program, negating 

one of the benefits of the review: to 

reduce market barriers. 

The Agency does not believe it is 

appropriate to delay implementation of 

the registration review program as 

suggested in the comments. In the 

absence of updated part 158 rules, the 

Agency makes case-by-case data 

determinations as a standard program 

practice. Registrants are familiar with 

this practice. While the Part 158 Data 

Requirements Rules and registration 

review decisions are related, they are 


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not inextricably linked. The revisions to 

part 158 have benefits but they are not 

a condition precedent to making 

registration review decisions. 

The part 158 updates may include 

provisions to codify current practices. 

The purpose of the part 158 rule is to 

capture with clarity and transparency 

changes in data requirements or 

application of data requirements that 

the Agency has made on a case-by-case 

document since it published its data 

requirements in 1984. This goodgovernment goal will amplify 

understanding and further enhance 

consistency. However, the registration 

review program can operate effectively, 

as the registration, reregistration, and 

tolerance reassessment programs have, 

in the absence of these enhancements. 

Final promulgation of the part 158 rules 

will simply improve on that sound 

foundation. 

Science will continue to evolve even 

after the Agency has completed the 

current revision of the data 

requirements in 40 CFR part 158. The 

Agency expects that it will change its 

data requirements to reflect this new 

knowledge. Because one of the goals of 

registration review is to incorporate 

evolving science, the Agency fully 

expects that it might apply new and 

different risk assessment tools to 

pesticides reviewed later in the 15–year 

cycle than it used when it reviewed 

pesticides early in the 15–year cycle. 

The Agency appreciates the 

commenter’s concern about market 

barriers that might arise if the Agency 

uses different risk assessment tools 

when reviewing pesticides later in the 

15–cycle than it used earlier in the 

cycle. Market barriers can be reduced if 

similar pesticides are reviewed at the 

same time. This is one of the benefits of 

the Agency’s plan to group chemically 

related cases for review. 

B. Transition from Reregistration to 

Registration Review 

Industry comments asserted that EPA 

must clarify when the registration 

review program will begin. EPA should 

address how it will handle the work of 

registration actions, reregistration 

actions, and other mandated regulatory 

actions before it commits to initiating 

the registration review program. EPA 

should clarify the transition process 

between the reregistration and 

registration review programs. 

The Agency has announced that the 

registration review program officially 

begins when these regulations go into 

effect. The Agency’s first actions under 

the new program will be to issue 

schedules and to begin to open 

registration review case dockets. As 

noted in the comment, some pesticides 

will still be undergoing reregistration 

when the registration review program 

begins. The Agency recognizes that, to 

avoid confusion during the transition 

between the reregistration and 

registration review programs, it must 

clearly communicate whether action on 

an existing pesticide is taken under 

reregistration (FIFRA section 4) or 

registration review under FIFRA section 

3(g). 

C. Unresolved Problems from 

Reregistration Will Affect the Agency’s 

Capacity to Conduct Registration 

Review 

Industry commented that EPA should 

not implement registration review of 

end-use products until it fixes the 

problems with the review of end-use 

products in reregistration. The review 

processes in registration review and 

reregistration are likely to be similar and 

registration review might duplicate the 

effort of reregistration, especially when 

a product may undergo product-specific 

review several times (e.g., a product that 

contains two or more active ingredients 

may belong in two or more registration 

review cases). The commenters are 

concerned that if EPA does not achieve 

efficiencies in the review of end-use 

products, the 15–year review will 

extend to 40 years. 

EPA expects reregistration to satisfy 

most product-specific data requirements 

and achieve many label improvements 

for end-use products. Although the 

Agency does not expect it will routinely 

require product-specific data during 

registration review, it expects that 

registration review will be an important 

vehicle for the continuing update of 

labels. The Agency agrees that the 

review of end-use product labels could 

benefit from process improvements. The 

Agency believes that registrants and 

other stakeholders can help develop 

approaches to make this process more 

efficient. 

IX. Program Costs 

A. Impacts on Small Businesses 

Registrants commented that EPA has 

not accurately characterized the effects 

of registration review on small business. 

They suggested that per-company costs 

of $750,000 and 2% gross sales are not 

insignificant even for large entities and 

will have a direct adverse effect on 

small businesses. They believe that the 

cost projections are misleading because 

they do not include all costs incurred by 

a registrant such as existing reporting, 

recordkeeping, and financial burdens 

imposed by the Agency’s many other 

on-going programs. Commenters 

suggested that EPA should re-evaluate 

the impacts on small business and 

reduce economic burden on them. 

EPA believes it has accurately 

characterized the impacts of the 

registration review procedures on the 

regulated community, including small 

businesses. The procedures in this rule 

establish what EPA will do to review a 

pesticide registration. They do not 

obligate a registrant to take any action. 

As part of the rulemaking process, 

EPA is required to estimate the 

economic impacts, including effects on 

small business, that occur as a 

consequence of the rule. Because costs 

resulting from existing reporting or 

recordkeeping requirements or costs 

from other Agency programs are not 

imposed by this rule, these costs are not 

included in the Agency’s assessment of 

the impacts of this rule. 

The regulations do not impose new 

data requirements. They establish the 

process by which EPA will decide if 

additional data are necessary to 

determine whether a pesticide 

continues to meet FIFRA standards. 

That is, data generation costs are only 

indirectly a result of registration review 

procedures. It is important to realize 

that the per-company costs of $750,000 

are primarily the cost of data generation; 

that is, they are not a direct cost 

imposed by this rule. 

The Agency has determined that this 

rule will not have a significant adverse 

impact on a substantial number of small 

businesses. Nonetheless, the Agency 

recognizes that, from the perspective of 

a small business whose product is 

undergoing registration review, the costs 

of data generation in registration review 

could be significant. Accordingly, the 

Agency is willing to work on a case-bycase basis with a small business for 

whom the requirements for data 

generation in registration review are 

burdensome. Data Call-In notices issued 

under FIFRA section 3(c)(2)(B) allow a 

registrant to request a data waiver that 

is based on economic factors. In lieu of 

a new study, the Agency is generally 

willing to consider whether substitute 

data or bridging data would be 

adequate. If a new study is required, the 

Agency may consider time extensions so 

that a registrant can spread the costs of 

data generation over a longer period of 

time. The Agency has made these 

options available to small businesses in 

the registration and reregistration 

programs and expects to continue to 

make them available for registration 

review. 

B. Cost of Product-Specific Data 

Industry comments asserted that the 

economic assessment was incomplete 


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Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations 45729 

because it did not include the costs of 

generating product-specific data, in 

particular, the costs of repeating efficacy 

tests for public health pesticides. At 

public meetings on the proposed rule, 

the Agency said that it would require 

new product efficacy tests. 

These comments accurately describe 

the scope of the feasibility study. The 

purpose of the feasibility study was to 

test the validity of the registration 

review decision paradigm and to 

develop data for estimating the costs of 

the program. The Agency did not review 

individual product registrations in the 

feasibility study to determine whether 

new product-specific data, including 

efficacy data, would be required because 

the Agency believes that, to a great 

degree, these product-specific data 

requirements have been satisfied 

through the registration and 

reregistration programs and such data 

would generally not be needed to 

support a pesticide’s registration review. 

During the registration review of a 

public health pesticide, the Agency 

would determine whether to continue to 

base the product’s registration on 

existing product efficacy data. The 

Agency may ask for new product 

efficacy data if the product’s 

composition has changed so that 

existing data no longer support the 

current composition of the product, or 

the test method is no longer valid, or 

there is information suggesting that the 

formulation might not be efficacious as 

claimed. The Agency did not review 

product chemistry data in the feasibility 

study to make case-by-case 

determinations whether existing 

product efficacy tests are appropriate for 

the composition of the product. The 

Agency has not revised antimicrobial 

efficacy test methods, so, for purposes of 

the feasibility study, the existing 

efficacy tests were considered to be 

valid. (If the Agency had information 

suggesting that a product in the 

feasibility study was not efficacious as 

claimed, the Agency would not wait 

until registration review to ask for new 

efficacy data. The Agency would have 

issued a DCI or initiated other action 

under FIFRA, as appropriate.) The 

Agency believes that the costs of 

replacing product efficacy data for a few 

products in a registration review case 

will be much lower than the costs of 

generating new generic data to support 

the active ingredient(s) in a registration 

review case. In any case, any costs for 

generating new product-specific efficacy 

data would not be a direct cost imposed 

by this procedural regulation. 

X. Technical Changes to the Rule 

In addition to the changes made in 

response to comments, the final rule 

reflects that the Agency made the 

following technical changes to what was 

proposed: 

1. In § 155.42(d), the Agency added 

clarifying phrases (indicated in italics) 

to the second and third sentences, as 

follows: ‘‘In general, the baseline date 

will be the date of initial registration of 

the oldest product in the case or the 

date of reregistration, whichever is later. 

The date of reregistration is the date on 

which the Registration Eligibility 

Decision or Interim Reregistration 

Eligibility Decision was signed, 

whichever date the Agency determines 

to be more appropriate based on the 

comprehensiveness of the review.’’

2. In § 155.44, EPA is deleting the 

sentence, ‘‘As indicated in § 155.40, the 

Agency may change the schedule of a 

pesticide’s registration review if 

circumstances warrant,’’ because it is 

not a correct reference. 

3. In § 155.48, EPA is deleting the 

phrase ‘‘before, during or after a 

registration review’’ because it is 

redundant. 

4. The Agency is modifying § 155.50 

as follows: 

• In the first sentence add the phrase 

‘‘except for cases covered under 

§ 155.46.’’ The sentence now reads, 

‘‘The Agency will initiate a pesticide’s 

registration review by establishing a 

docket for each registration review case, 

except for cases covered under § 155.46, 

and opening it for public review.’’

• Change the paragraph heading of 

§ 155.50(a) to ‘‘Contents of the 

registration review case docket.’’ The 

Agency has deleted the first sentence of 

this paragraph and modified the last 

sentence to read, ‘‘The Agency will 

consider including, but not limited to, 

the following information: . . .’’ The 

Agency is making these changes to make 

clear that this paragraph describes the 

contents of the initial docket. 

• Change § 155.50(c) by adding 

‘‘during the comment period’’ to the 

paragraph heading and by changing the 

first sentence in paragraph (c)(1) to read 

as follows: ‘‘In order to ensure that the 

Agency will consider data or 

information in the conduct of a 

registration review, interested persons 

must submit the data or information 

during the comment period established 

in the notice described in paragraph (b) 

of this section.’’ These changes are for 

clarity. 

• Add paragraph § 155.50(d) as 

follows, ‘‘For the purposes of this 

subpart, the provisions of subpart B do 

not apply.’’ EPA is making this change 

to eliminate any possible confusion as 

to whether docketing procedures in part 

155 subpart B apply to registration 

review activities. Subpart B describes 

docketing and public participation 

procedures for the registration standard 

program that the Agency conducted 

before it began the reregistration process 

mandated in the 1988 amendments to 

FIFRA. The Agency will eventually 

issue a housekeeping rule to delete this 

subpart. 

5. In § 155.52, the Agency is making 

editorial changes for clarity, as follows: 

• Substitute ‘‘other persons’’ for 

‘‘public interest groups’’ in the third 

sentence so that it reads, ‘‘The Agency 

may consult with registrants, pesticide 

users, or other persons during a 

pesticide’s registration review . . .’’

• Add the phrase ‘‘Minutes of’’ to the 

paragraph heading of § 155.52(a) so that 

it reads, ‘‘Minutes of meetings with 

persons outside of government.’’

6. In § 155.53, the Agency is making 

several editorial changes for clarity, as 

follows: 

• Add the preposition ‘‘of’’ to the 

section heading of § 155.53 so that it 

reads, ‘‘Conduct of a pesticide’s 

registration review.’’

• In the first sentence of this section, 

replace the reference to ‘‘§ 155.51,’’

which doesn’t exist, with ‘‘§ 155.50(a), 

(b), and (c).’’

• In the first sentence of 

§ 155.53(c)(1), replace the phrase ‘‘ask 

for’’ with the verb ‘‘request.’’

7. In § 155.58, the Agency is making 

an editorial change in paragraph (b)(3) 

by deleting the phrase ‘‘precede, 

accompany or follow’’ from the second 

sentence and replacing it with the 

phrase ‘‘may be issued in conjunction 

with.’’

XI. FIFRA Review Requirements 

In accordance with FIFRA section 

25(a) and 25(d), this rule was submitted 

to the FIFRA Science Advisory Panel 

(SAP), the Secretary of Agriculture 

(USDA), and appropriate Congressional 

Committees. 

XII. Statutory and Executive Order 

Reviews 

A. Executive Order 12866 

Pursuant to Executive Order 12866, 

entitled Regulatory Planning and 

Review (58 FR 51735, October 4, 1993), 

the Office of Management and Budget 

(OMB) has designated this rule as a 

‘‘significant regulatory action’’ under 

section 3(f) of the Executive Order 

because it may raise novel legal or 

policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the Executive 


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Order. This action was therefore 

submitted to OMB for review under this 

Executive Order, and any changes to 

this document made at the suggestion of 

OMB have been documented in the 

public docket for this rulemaking. 

EPA has prepared an economic 

analysis of the potential impacts of the 

registration review procedures. In 

addition to analyzing the requirements 

contained in this rule, the Agency 

analyzed other potential actions that 

could occur during a registration review 

using other existing authorities that are 

not changed in this rule. The Agency’s 

analysis, therefore, considers the 

potential impact of the registration 

review process, which includes the 

costs of a registrant’s participation in 

the public review components of the 

process described in this rule and other 

potential requirements imposed by 

existing authorities such as data 

generation under FIFRA section 

3(c)(2)(B). This analysis is contained in 

a document entitled Economic Analysis 

of the Procedural Regulations for the 

Registration Review of Pesticides. EPA 

placed a copy of this Economic Analysis 

in the public docket for this action 

when it published the proposed rule. 

Comments on the Economic Analysis 

did not warrant revision of this 

document and the Agency will rely on 

this document to support the final rule. 

The Economic Analysis is briefly 

summarized here. 

The rule does not require registrants 

to take specific action as part of the 

review of a pesticide registration, 

however, the Agency’s analysis assumes 

that registrants will engage in their own 

evaluation of information provided by 

the Agency and other stakeholders, and 

participate in the public process 

described in this rule. The Agency 

estimates such industry costs to be 

around $1.2 million annually. 

The Agency recognizes that under 

other existing authorities a registrant 

may also need to submit data that they 

have or generate data as necessary to 

support the registration. As such, the 

analysis also considers the potential 

cost to industry from other anticipated 

activities under existing authorities that 

may occur during the registration 

review process, although such activities 

are not requirements in this rulemaking. 

These activities include potential data 

submission or generation activities 

related to DCIs, including the 

paperwork burden, and other activities 

that might occur under other existing 

authorities. 

Considering these other potential 

activities, the analysis shows an 

estimated total annual cost to industry 

of about $50 million, with the estimates 

for potential data generation activities 

accounting for approximately 70% of 

these costs. The Agency estimates about 

68 companies will be impacted each 

year; thus, per-company costs for the 

entire registration review process are 

likely to average less than $750,000 each 

year, even though some companies may 

have multiple chemicals under review 

during the year. Out of the universe of 

2,000 small businesses estimated to 

hold pesticide registrations, the Agency 

estimates that each year about 30 small 

businesses that have responsibility for 

providing data to support the 

registration of a pesticide would be 

involved in a registration review. 

Assuming the same level of 

participation and potential need to 

generate data, the estimated average cost 

of the registration review process is 

estimated to be less than 2% of the gross 

sales for small businesses involved in a 

registration review. 

B. Paperwork Reduction Act (PRA) 

The information collection activities 

associated with the registration review 

program are already approved by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act, 44 U.S.C. 3501 et seq. That 

Information Collection Request (ICR) 

document has been assigned EPA ICR 

number 0922.07, and OMB control 

number 2070–0057. Although this 

action does not impose any new 

information collection requirements that 

would require additional approval by 

OMB, the Agency expects the approved 

burden estimate to increase with the full 

implementation of the registration 

review process. A copy of the OMB 

approved ICR has been placed in the 

public docket for this rule, and the 

Agency’s estimated burden increase is 

presented in the economic analysis that 

has been prepared for this rule. 

As detailed in the Economic Analysis 

prepared for this rule, the annual 

respondent burden for information 

collection activities associated with the 

registration review program is estimated 

to average 120,000 hours, with an 

estimated total annual respondent cost 

of $10,800,000. The July 13, 2005, 

proposed rule invited comments on the 

Agency’s need for this information, the 

accuracy of the provided burden 

estimates, and any suggested methods 

for minimizing respondent burden, 

including the use of automated 

collection techniques. No comments 

were received. Therefore, the Agency 

has submitted an information correction 

worksheet request to OMB to amend its 

existing ICR covering the information 

collection activities associated with the 

registration review program so that it 

reflects the burden estimates in the 

Economic Analysis. 

Under the PRA, ‘‘burden’’ means the 

total time, effort, or financial resources 

expended by persons to generate, 

maintain, retain, or disclose or provide 

information to or for a Federal agency. 

This includes the time needed to review 

instructions; develop, acquire, install, 

and utilize technology and systems for 

the purposes of collecting, validating, 

and verifying information, processing 

and maintaining information, and 

disclosing and providing information; 

adjust the existing ways to comply with 

any previously applicable instructions 

and requirements; train personnel to be 

able to respond to a collection of 

information; search data sources; 

complete and review the collection of 

information; and transmit or otherwise 

disclose the information. 

Under the PRA, an agency may not 

conduct or sponsor, and a person is not 

required to respond to a collection of 

information unless it displays a 

currently valid OMB control number. 

The OMB control numbers for EPA’s 

regulations codified in Chapter 40 of the 

CFR, after appearing in the preamble of 

the final rule, are listed in 40 CFR part 

9, are displayed either by publication in 

the Federal Register or by other 

appropriate means, such as on the 

related collection instrument or form, if 

applicable. The display of OMB control 

numbers in certain EPA regulations is 

consolidated in 40 CFR part 9. For the 

ICR activity contained in this final rule, 

in addition to displaying the applicable 

OMB control number in this unit, the 

Agency is amending the table in 40 CFR 

9.1 to list the OMB control number 

assigned to this ICR activity. Due to the 

technical nature of the table, EPA finds 

that further notice and comment about 

amending the table is unnecessary. As a 

result, EPA finds that there is ‘‘good 

cause’’ under section 553(b)(B) of the 

Administrative Procedures Act (APA), 5 

U.S.C. 553(b)(B), to amend this table 

without further notice and comment. 

C. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 601 et seq., the Agency hereby 

certifies that this rule will not have a 

significant adverse economic impact on 

a substantial number of small entities. 

This rule defines the procedures that 

EPA will follow to implement the 

statutory registration review provision. 

It does not impose any new 

requirements on the regulated 

community. As such, this rule does not 

have direct adverse impacts on small 

businesses, small non-profit 


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organizations, or small local 

governments. 

For purposes of assessing the impacts 

of this rule on small entities, small 

entity is defined as: (1) A small business 

as defined by the Small Business 

Administration’s (SBA) regulations at 13 

CFR 121.201, which for the pesticide 

industry consists of businesses with 

fewer than 500 to 1,000 employees 

(range is based on NAICS sector 

variations); (2) a small governmental 

jurisdiction that is a government of a 

city, county, town, school district or 

special district with a population of less 

than 50,000; and (3) a small 

organization that is any not-for-profit 

enterprise which is independently 

owned and operated and is not 

dominant in its field. The regulated 

community does not include any small 

not-for-profit organizations. Small local 

government organizations, such as 

counties, may register a pesticide under 

FIFRA section 24(c). However, such 

registrants generally do not 

manufacture, distribute or sell 

pesticides and generally would not be 

responsible for generating data to 

support the registration of pesticides. 

Accordingly, the Agency finds that this 

rule does not have a direct adverse 

effect on small local governments. 

D. Unfunded Mandates Reform Act 

Under Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

(Public Law 104–4), EPA has 

determined that this action does not 

contain a Federal mandate that may 

result in expenditures of $100 million or 

more for State, local, and tribal 

governments, in the aggregate, or the 

private sector in any one year. As 

described in Unit XIII.A., this rule is not 

expected to result in such expenditures. 

In addition, this action will not impact 

small governments, or local or tribal 

governments. Accordingly, this rule is 

not subject to the requirements of 

sections 202, 203, 204, and 205 of 

UMRA. 

E. Executive Order 13132 

Pursuant to Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), EPA has determined 

that this rule does not have ‘‘federalism 

implications,’’ because it will not have 

substantial direct effects on the states, 

on the relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in the 

Order. Thus, Executive Order 13132 

does not apply to this rule. 

F. Executive Order 13175 

As required by Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

6, 2000), EPA has determined that this 

rule does not have tribal implications 

because it will not have any affect on 

tribal governments, on the relationship 

between the Federal government and 

the Indian tribes, or on the distribution 

of power and responsibilities between 

the Federal government and Indian 

tribes, as specified in the Order. Thus, 

Executive Order 13175 does not apply 

to this rule. 

G. Executive Order 13211 

This rule is not subject to Executive 

Order 13211, entitled Actions 

Concerning Regulations that 

Significantly Affect Energy Supply, 

Disribution, or Use (66 FR 28355, May 

22, 2001) because it is not designated as 

an ‘‘economically significant’’

regulatory action as defined by 

Executive Order 12866 (see Unit 

XIII.A.), nor is it likely to have any 

significant adverse effect on the supply, 

distribution, or use of energy. 

H. Executive Order 13045 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997) does 

not apply to this rule because this action 

is not designated as an ‘‘economically 

significant’’ regulatory action as defined 

by Executive Order 12866, (see Unit 

XIII.A.), nor does it establish an 

environmental standard, or otherwise 

have a disproportionate effect on 

children. 

I. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 ((NTTAA), 15 U.S.C. 272 

note) directs EPA to use voluntary 

consensus standards in its regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures) that are 

developed or adopted by voluntary 

consensus standards bodies. This rule 

does not impose any technical standards 

that would require EPA to consider any 

voluntary consensus standards. 

J. Executive Order 12898 

This rule does not have an adverse 

impact on the environmental and health 

conditions in low-income and minority 

communities. Therefore, under 

Executive Order 12898, entitled Federal 

Actions to Address Environmental 

Justice in Minority Populations and 

Low-Income Populations (59 FR 7629, 

February 16, 1994), the Agency does not 

need to consider environmental justicerelated issues. 

XIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

Agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and the Comptroller General of 

the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of the rule in 

the Federal Register. This rule is not a 

‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 9 

Environmental protection, Reporting 

and recordkeeping requirements. 

List of Subjects in 40 CFR Part 155 

Environmental protection, 

Administrative practice and procedure, 

Pesticides and pests. 

Dated: August 1, 2006. 

Stephen L. Johnson, 

Administrator. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

■ 1. Part 9 is amended as follows: 

PART 9—[AMENDED] 

■ a. The authority citation for part 9 

continues to read as follows: 

Authority: 7 U.S.C. 135 et seq., 136–136y; 

15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671, 

21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 

U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 

1321, 1326, 1330, 1342, 1344, 1345 (d) and 

(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 

1971–1975 Comp. p. 973; 42 U.S.C. 241, 

242b, 243, 246, 300f, 300g, 300g–1, 300g–2, 

300g–3, 300g–4, 300g–5, 300g–6, 300j–1, 

300j–2, 300j–3, 300j–4, 300j–9, 1857 et seq., 

6901–6992k, 7401–7671q, 7542, 9601–9657, 

11023, 11048. 

■ b. In § 9.1, the table is amended by 

revising the existing heading for 

‘‘Registration Standards’’; removing the 

entry under that heading; and adding a 

new entry to read as follows: 

§ 9.1 OMB approvals under the Paperwork 

Reduction Act. 

* * * * * 


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45732 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations 

40 CFR citation OMB control no. 

* * * * * 

.

Registration Standards and Registration 

Review 

* * * * * 

Part 155 .......................... 2070–0057 

* * * * * 

■ 2. Part 155 is amended as follows: 

PART 155–REGISTRATION 

STANDARDS AND REGISTRATION 

REVIEW 

■ a. The authority citation for part 155 

continues to read as follows: 

Authority: 7 U.S.C. 1361. 

■ b. By revising the heading of part 155 

to read as set forth above. 

■ c. By adding a new subpart C to read 

as follows: 

Subpart C—Registration Review 

Procedures 

Sec. 

155.40 General. 

155.42 Registration review cases. 

155.44 Establish schedules for registration 

review. 

155.46 Deciding that a registration review is 

complete and additional review is not 

needed. 

155.48 Data Call-In. 

155.50 Initiate a pesticide’s registration 

review. 

155.52 Stakeholder engagement. 

155.53 Conduct of a pesticide’s registration 

review. 

155.56 Interim registration review decision. 

155.57 Registration review decision. 

155.58 Procedures for issuing a decision on 

a registration review case. 

Subpart C—Registration Review 

Procedures 

§ 155.40 General. 

(a) Purpose. These regulations 

establish procedures for the registration 

review program required in FIFRA 3(g). 

Registration review is the periodic 

review of a pesticide’s registration to 

ensure that each pesticide registration 

continues to satisfy the FIFRA standard 

for registration. The goal of the 

registration review procedures is review 

of each pesticide’s registration every 15 

years. 

(1) Among other things, FIFRA 

requires that a pesticide generally will 

not cause unreasonable adverse effects 

on the environment. Registration review 

is intended to ensure that each 

pesticide’s registration is based on 

current scientific and other knowledge 

regarding the pesticide, including its 

effects on human health and the 

environment. 

(2) If a product fails to satisfy the 

FIFRA standard for registration, the 

product’s registration may be subject to 

cancellation or other remedies under 

FIFRA. 

(b) Applicability. This subpart applies 

to every pesticide product registered 

under FIFRA section 3 as well as all 

pesticide products registered under 

FIFRA section 24(c). It does not apply 

to products whose sale or distribution is 

authorized under FIFRA section 5 or 

section 18. 

(c) Limitations. (1) At any time, the 

Agency may undertake any other review 

of a pesticide under FIFRA, irrespective 

of the pesticide’s past, ongoing, 

scheduled, or not yet scheduled 

registration review. 

(2) When the Agency determines that 

new data or information are necessary 

for a pesticide’s registration review, it 

will require such data under FIFRA 

section 3(c)(2)(B). 

§ 155.42 Registration review cases. 

(a) Establishing registration review 

cases. A registration review case will be 

composed of one or more active 

ingredients and all the products 

containing such ingredient(s). The 

Agency may group related active 

ingredients into a registration review 

case when the active ingredients are so 

closely related in chemical structure 

and toxicological profile as to allow 

common use of some or all required 

data for hazard assessment. 

(1) Existing pesticides. The Agency 

will assign each pesticide registered on 

or before the effective date of this 

regulation to a registration review case. 

(2) New pesticides. The Agency will 

assign each pesticide registered after the 

effective date of this regulation to an 

existing registration review case or to a 

new registration review case. 

(3) A pesticide product that contains 

multiple active ingredients will belong 

to the registration review cases for each 

of its active ingredients. 

(b) Modifying registration review 

cases. New data or information may 

suggest that a registration review case 

should be modified. The Agency may 

modify a registration review case in the 

following ways: 

(1) Add a new active ingredient to a 

registration review case. The Agency 

may determine that a new active 

ingredient is chemically and 

toxicologically similar to active 

ingredients in an existing registration 

review case and should be grouped with 

the ingredients in the existing 

registration review case. 

(2) Split a registration review case 

into two or more registration review 

cases. For example, new data or 

information may suggest that active 

ingredients in a registration review case 

are not as similar as previously believed 

and that they belong in two or more 

separate registration review cases. 

(3) Move an ingredient from one 

registration review case to another. For 

example, new data or information might 

suggest that an ingredient should not be 

grouped with the other ingredients in 

the registration review case and that it 

belongs in a different registration review 

case. 

(4) Merge two or more registration 

review cases into a single registration 

review case. For example, new data or 

information might suggest that the 

active ingredients in two or more 

registration review cases should be 

grouped together for registration review. 

(5) Delete an active ingredient from a 

registration review case. For example, 

the Agency will remove the ingredient 

from the case if the registrations of all 

products containing an active ingredient 

in a registration review case are 

canceled. 

(c) Closing a registration review case. 

The Agency will close a registration 

review case if all products in the case 

are canceled. 

(d) Establishing a baseline date for a 

registration review case. For the purpose 

of scheduling registration reviews, the 

Agency will establish a baseline date for 

each registration review case. In general, 

the baseline date will be the date of 

initial registration of the oldest pesticide 

product in the case or the date of 

reregistration, whichever is later. For 

the purpose of these procedures, the 

date of reregistration is the date on 

which the Reregistration Eligibility 

Decision or Interim Reregistration 

Decision was signed, whichever date the 

Agency determines to be more 

appropriate based on the 

comprehensiveness of the review. 

(1) The Agency generally will not 

change the baseline date for a 

registration review case when it 

modifies a case by adding or deleting 

ingredients or products. 

(2) When the Agency splits a 

registration review case into two or 

more cases, the new case(s) generally 

will have the baseline date of the 

original registration review case. 

(3) When the Agency merges two or 

more registration review cases into a 

single case, the Agency generally will 

use the earliest baseline date as the 

baseline date for the new case. 

(e) Announcing registration review 

cases and baseline dates. The Agency 

will maintain a list of registration 

review cases, including baseline dates, 

on its website. 


jlentini on PROD1PC65 with RULES3
Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations 45733 

§ 155.44 Establish schedules for 

registration review. 

The Agency will develop schedules 

for registration review that are generally 

based on the baseline date of the 

registration review case or on the date 

of the latest registration review of the 

registration review case. The Agency 

may also take into account other factors, 

such as achieving process efficiencies 

by reviewing related cases together, 

when developing schedules for 

registration review. The Agency will 

maintain schedules for the current year 

and at least two subsequent years on its 

website. 

§ 155.46 Deciding that a registration 

review is complete and additional review is 

not needed. 

The Agency may determine that there 

is no need to reconsider a previous 

decision that a pesticide satisfies the 

standard of registration in FIFRA. In 

such cases, instead of establishing a 

pesticide registration review case docket 

as described in § 155.50, the Agency 

may propose that, based on its 

determination that a pesticide meets the 

FIFRA standard for registration, no 

further review will be necessary. In such 

circumstances, the Agency will publish 

a notice in the Federal Register 

announcing the availability of the 

proposed decision and provide a 

comment period of at least 60 calendar 

days. The Agency will publish a notice 

in the Federal Register announcing the 

availability of a final version of the 

decision, an explanation of any changes 

to the proposed decision and its 

response to any comments. The date of 

the final notice of availability would be 

used as the date of the latest registration 

review for the purpose of scheduling 

subsequent registration reviews. 

§ 155.48 Data Call-In. 

The Agency may issue a Data Call-In 

notice under FIFRA section 3(c)(2)(B) at 

any time if the Agency believes that the 

data are needed to conduct the 

registration review. The provisions in 

FIFRA section 3(c)(1), (c)(2)(B), and 

(c)(2)(D) apply to the submission, 

compensation, and exemption of data 

required to conduct a registration 

review. 

§ 155.50 Initiate a pesticide’s registration 

review. 

The Agency will initiate a pesticide’s 

registration review by establishing a 

docket for each registration review case, 

except for cases covered under § 155.46, 

and opening it for public review. 

(a) Contents of the registration review 

case docket. The Agency will place in 

this docket information that will assist 

the public in understanding the types of 

information and issues that the Agency 

may consider in the course of the 

registration review. The Agency may 

include information from its files 

including, but not limited to, the 

following information: 

(1) An overview of registration review 

case status; 

(2) A list of current registrations and 

registrants, any Federal Register notices 

regarding pending registration actions, 

and current or pending tolerances; 

(3) Risk assessment documents; 

(4) Bibliographies concerning current 

registrations; 

(5) Summaries of incident data; and 

(6) Any other pertinent data or 

information. 

(b) Public review of the registration 

review case docket. The Agency will 

publish a notice in the Federal Register 

announcing the availability for public 

review of the information described in 

paragraph (a) of this section and 

establishing a comment period of at 

least 60 days. During this comment 

period, interested persons may identify 

any additional information they believe 

the Agency should consider in the 

course of the registration review. 

(c) Submission of data and other 

information during the comment period. 

The Agency may identify, either in the 

notice published under paragraph (b) of 

this section, or at any other time, data 

or information that it does not have but 

which may be useful, if available, for 

consideration in the registration review. 

Any person may submit data or 

information in response to such 

identification. In order to be considered 

during a pesticide’s registration review, 

the submitted data or information must 

meet the requirements listed below. 

(1) In order to ensure that the Agency 

will consider data or information in the 

conduct of a registration review, 

interested persons must submit the data 

or information during the comment 

period established in the notice 

described in paragraph (b) of this 

section. The Agency may, at its 

discretion, consider data or information 

submitted at a later date. 

(2) The data or information must be 

presented in a legible and useable form. 

For example, an English translation 

must accompany any material that is not 

in English and a written transcript must 

accompany any information submitted 

as an audiographic or videographic 

record. Written material may be 

submitted in paper or electronic form. 

(3) Submitters must clearly identify 

the source of any submitted data or 

information. 

(4) Submitters may request the 

Agency to reconsider data or 

information that the Agency rejected in 

a previous review. However, submitters 

must explain why they believe the 

Agency should reconsider the data or 

information in the pesticide’s 

registration review. 

(d) For the purposes of this subpart, 

the provisions of subpart B do not 

apply. 

§ 155.52 Stakeholder engagement. 

In addition to the public participation 

opportunities described in § 155.50 and 

§ 155.53(c), the Agency may meet with 

stakeholders regarding a forthcoming or 

ongoing registration review. For 

example, before conducting a pesticide’s 

registration review, the Agency may 

consult with registrants or pesticide 

users regarding the use and usage of the 

pesticide. The Agency may consult with 

registrants, pesticide users, or other 

persons during a pesticide’s registration 

review with regard to developing risk 

management options for a pesticide. The 

Agency may informally consult with 

officials of Federal, State or Tribal 

agencies regarding a forthcoming or 

ongoing registration review. 

(a) Minutes of meetings with persons 

outside of government. The Agency will 

place in the docket minutes of meetings 

with persons outside of government 

where the primary purpose of the 

meeting is to discuss a forthcoming or 

ongoing registration review. The Agency 

will place minutes of such meetings in 

the docket when it takes action under 

§ 155.58. At its discretion, the Agency 

may place minutes of such meetings in 

the docket sooner. 

(b) Exchange of documents or other 

written material. In the course of a 

meeting with a person outside of 

government, the Agency or that person 

may provide the other with a copy of a 

document or other written material that 

has not yet been released to the public. 

The Agency will place a copy of any 

such document or other written material 

in the docket along with the minutes of 

the meeting where the materials were 

exchanged. 

(c) Confidential business information. 

The Agency will not place confidential 

business information in the docket. 

§ 155.53 Conduct of a pesticide’s 

registration review. 

The Agency will review data and 

information described in § 155.50(a), (b), 

and (c) or submitted in response to a 

Data Call-In notice that it believes 

should be considered in the pesticide’s 

registration review. 

(a) Assess changes since a pesticide’s 

last review. The Agency will assess any 

changes that may have occurred since 

the Agency’s last registration decision in 

order to determine the significance of 


jlentini on PROD1PC65 with RULES3
45734 Federal Register / Vol. 71, No. 153 / Wednesday, August 9, 2006 / Rules and Regulations 

such changes and whether the pesticide 

still satisfies the FIFRA standard for 

registration. The Agency will consider 

whether to conduct a new risk 

assessment to take into account, among 

other things, any changes in statutes or 

regulations, policy, risk assessment 

procedures or methods, or data 

requirements. The Agency will consider 

whether any new data or information on 

the pesticide, including any data or 

information submitted under § 155.50 or 

in response to a Data Call-In notice, 

warrant conducting a new risk 

assessment or a new risk/benefit 

assessment. The Agency will also 

consider whether any new data or 

information regarding an individual 

pesticide product, including any data or 

information submitted under § 155.50 or 

in response to a Data Call-In notice, 

such as data or information about an 

inert ingredient in the pesticide product 

or other information or data relating to 

the composition, labeling or use of the 

pesticide product, warrant additional 

review of a pesticide product’s 

registration. 

(b) Conduct new assessments as 

needed. (1) Active ingredient(s) in the 

registration review case. If the Agency 

finds that a new assessment of the 

pesticide is needed, it will determine 

whether it can base the new assessment 

on available data or information, 

including data or information submitted 

under § 155.50 or in response to a Data 

Call-In notice. If sufficient data or 

information are available, the Agency 

will conduct the new risk assessment or 

risk/benefit assessment. If the Agency 

determines that additional data or 

information are needed to conduct the 

review, the Agency will issue a Data 

Call-In notice under FIFRA section 

3(c)(2)(B). 

(2) Individual product registrations. If 

the Agency finds that additional review 

of an individual product’s registration is 

needed, it will review the pesticide 

product label, confidential statement of 

formula, product-specific data, or other 

pertinent data or information, as 

appropriate, to determine whether the 

registration of the individual product 

meets the FIFRA standard for 

registration. If the Agency determines 

that additional data or information are 

needed to conduct the review, the 

Agency will issue a Data Call-In notice 

under FIFRA section 3(c)(2)(B). 

(c) Public participation during a 

pesticide’s registration review. The 

Agency will generally make available 

for public review and comment a draft 

risk assessment for a pesticide if a new 

risk assessment has been conducted. 

The Agency will publish a notice in the 

Federal Register announcing the 

availability of the draft risk assessment 

and provide a comment period of at 

least 30 calendar days. The Agency will 

publish a notice in the Federal Register 

announcing the availability of a revised 

risk assessment, an explanation of any 

changes to the proposed document, and 

its response to comments. If the revised 

risk assessment indicates risks of 

concern, the Agency may, in the notice 

announcing the availability of the 

revised risk assessment, provide a 

comment period of at least 30 calendar 

days for the public to submit 

suggestions for mitigating the risk 

identified in the revised risk 

assessment. 

(1) The Agency might not request 

comments on a draft risk assessment in 

cases where the Agency’s initial 

screening of a pesticide indicates that it 

has low use/usage, affects few if any 

stakeholders or members of the public, 

poses low risk, and/or requires little or 

no risk mitigation. In such cases, the 

Agency will make a draft risk 

assessment available for public review 

and comment when it issues a proposed 

decision on the registration review case. 

(2) If the Agency finds that it is not 

necessary to conduct a new risk 

assessment, it will issue a proposed 

decision on the registration review case 

as described in § 155.58. 

§ 155.56 Interim registration review 

decision. 

The Agency may issue, when it 

determines it to be appropriate, an 

interim registration review decision 

before completing a registration review. 

Among other things, the interim 

registration review decision may require 

new risk mitigation measures, impose 

interim risk mitigation measures, 

identify data or information required to 

complete the review, and include 

schedules for submitting the required 

data, conducting the new risk 

assessment and completing the 

registration review. A FIFRA 3(c)(2)(B) 

notice requiring the needed data or 

information may precede, accompany, 

or follow issuance of the interim 

registration review decision. The 

Agency will follow procedures in 

§ 155.58 when issuing an interim 

registration review decision. 

§ 155.57 Registration review decision. 

A registration review decision is the 

Agency’s determination whether a 

pesticide meets, or does not meet, the 

standard for registration in FIFRA. 

§ 155.58 Procedures for issuing a decision 

on a registration review case. 

(a) The Agency will publish a notice 

in the Federal Register announcing the 

availability of a proposed registration 

review decision or a proposed interim 

registration review decision. At that 

time, the Agency will place in the 

pesticide’s registration review docket 

the Agency’s proposed decision and the 

bases for the decision. There will be a 

comment period of at least 60 calendar 

days on the proposed decision. 

(b) In its proposed decision, the 

Agency will, among other things: 

(1) State its proposed findings with 

respect to the FIFRA standard for 

registration and describe the basis for 

such proposed findings. 

(2) Identify proposed risk mitigation 

measures or other remedies as needed 

and describe the basis for such proposed 

requirements. 

(3) State whether it believes that 

additional data are needed and, if so, 

describe what is needed. A FIFRA 

3(c)(2)(B) notice requiring such data 

may be issued in conjunction with a 

proposed or final decision on the 

registration review case or a proposed or 

final interim decision on a registration 

review case. 

(4) Specify proposed labeling changes; 

and 

(5) Identify deadlines that it intends 

to set for completing any required 

actions. 

(c) After considering any comments 

on the proposed decision, the Agency 

will issue a registration review decision 

or interim registration review decision. 

This decision will include an 

explanation of any changes to the 

proposed decision and the Agency’s 

response to significant comments. The 

Agency will publish a notice in the 

Federal Register announcing the 

availability of a registration review 

decision or interim registration review 

decision. The registration review case 

docket will remain open until all 

actions required in the final decision on 

the registration review case have been 

completed. 

(d) If the registrant fails to take the 

action required in a registration review 

decision or interim registration review 

decision, the Agency may take 

appropriate action under FIFRA. 

[FR Doc. E6–12904 Filed 8–8–06; 8:45 am] 

BILLING CODE 6560–50–S 


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