Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Proposed Rules 68297 

noncontroversial, and does not 

substantively change the proposed rule. 

II. What are the corrections to the 

proposed rules (75 FR 63260)? 

In this notice, we are clarifying the 

scope of the proposed affirmative 

defense for exceedance of an emission 

limit or standard during a malfunction. 

See proposed regulatory text at 75 FR 

63260. Specifically, we are clarifying 

the regulatory text to reflect that the 

affirmative defense is available only 

against claims for civil penalties. The 

preamble to the October 14, 2010 (75 FR 

63283), notice stated this position, as 

did other portions of the proposed 

regulatory text. See 75 FR 63299 

proposed § 60.4861(b) and 75 FR 63323 

proposed § 60.5181(b). However, one 

sentence in the regulatory text created a 

potential ambiguity that may not have 

reflected the Agency’s intent. Therefore, 

we are clarifying this in the proposed 

regulatory text to explain that a facility 

may assert an affirmative defense to a 

claim for civil penalties for exceedances 

of the standards that are caused by a 

malfunction, as defined in 40 CFR 60.2, 

but may not assert such a defense to a 

claim for injunctive relief. 

EPA is soliciting public comment on 

the proposed SSI rule published on 

October 14, 2010, until November 15, 

2010, unless a public hearing is held. If 

a public hearing is held, then comments 

on the proposed SSI rule published on 

October 14, 2010, must be received by 

November 29, 2010. Members of the 

public may also comment on this 

technical correction during that time, 

and should submit any such comments 

to the docket for that proposed rule. 

Submit your comments, identified by 

Docket ID Number EPA–HQ–OAR– 

2009–0559, by one of the following 

methods identified in 75 FR 63260. 

III. Statutory and Executive Order 

Reviews 

EPA’s compliance with relevant 

statutes and Executive Orders for the 

proposed SSI rule is discussed in the 

October 14, 2010, Federal Register 

notice titled ‘‘Standards of Performance 

for New Stationary Sources and 

Emission Guidelines for Existing 

Sources: Sewage Sludge Incineration 

Units.’’ (75 FR 63260). This technical 

correction does not affect the analyses 

contained in the October 14, 2010, 

notice. 

List of Subjects in 40 CFR Part 60 

Environmental protection, 

Administrative practice and procedure, 

Air pollution control, Intergovernmental 

relations, Reporting and recordkeeping 

requirements. 

Dated: October 29, 2010. 

Gina A. McCarthy, 

Assistant Administrator. 

For the reasons stated in the 

preamble, FR Doc. No. 2010–25122, 

published in the Federal Register on 

October 14, 2010, at 75 FR 63260 is 

corrected as follows: 

1. Beginning on page 63298, in the 

third column, remove the second 

sentence in § 60.4861 introductory text 

and add the following two sentences in 

its place: ‘‘Appropriate penalties may be 

assessed, however, if the respondent 

fails to meet its burden of proving all of 

the requirements in the affirmative 

defense. The affirmative defense shall 

not be available for claims for injunctive 

relief.’’ 

2. On page 63323, in the center 

column, remove the second sentence in 

§ 60.5181 introductory text and add the 

following two sentences in its place: 

‘‘Appropriate penalties may be assessed, 

however, if the respondent fails to meet 

its burden of proving all of the 

requirements in the affirmative defense. 

The affirmative defense shall not be 

available for claims for injunctive 

relief.’’ 

[FR Doc. 2010–28002 Filed 11–4–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 152 

[EPA–HQ–OPP–2009–0456; FRL–8424–8] 

RIN 2070–AJ58 

Pesticides; Satisfaction of Data 

Requirements; Procedures To Ensure 

Protection of Data Submitters’ Rights 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA proposes to revise its 

regulations governing procedures for the 

satisfaction of data requirements under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA). These 

provisions include, among other things, 

procedures for the protection of 

exclusive use and data compensation 

rights of data submitters. The proposed 

revisions would update the regulations, 

which have not been revised since 

issuance in 1984, to accommodate 

statutory and procedural changes that 

have occurred since that time. The 

revisions would also make minor 

changes to clarify the regulations. The 

revisions would simplify the procedures 

and reduce burdens for certain data 

submitters. 

DATES: Comments must be received on 

or before January 4, 2011. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2009–0456, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPP–2009– 

0456. EPA’s policy is that all comments 

received will be included in the docket 

without change and may be made 

available on-line at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The regulations.gov Web site is an 

‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

EPA may not be able to consider your 

comment. Electronic files should avoid 

the use of special characters, any form 

of encryption, and be free of any defects 

or viruses. 

Docket: All documents in the docket 

are listed in the docket index available 

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68298 Federal Register / Vol. 75, No. 214 / Friday, November 5, 2010 / Proposed Rules 

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 OPP 

Regulatory Public Docket in Rm. S– 

4400, One Potomac Yard (South Bldg.), 

2777 S. Crystal Dr., Arlington, VA. The 

hours of operation of this Docket 

Facility are from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Cameo G. Smoot, Field and External 

Affairs Division, Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–5454; fax number: 

(703) 305–5884; e-mail address: 

smoot.cameo@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this action apply to me? 

You may be potentially affected by 

this action if you produce pesticide 

products that require registration with 

EPA (NAICS code 32532). 

This listing is not all-inclusive, 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 § 152.81 of 

the regulatory text. 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. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or e-mail. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. Background 

A. Statutory Authority 

Under the Federal Insecticide, 

Fungicide, and Rodenticide Act 

(FIFRA), 7 U.S.C. 136 et seq., EPA 

regulates the sale, distribution and use 

of pesticides, and the allowable levels of 

such pesticides in or on food under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), 21 U.S.C. 346a. EPA 

regulations covering activities under 

these statutes are located in 40 CFR 

parts 150–180. 

The process of registering a pesticide 

begins with submission to EPA of an 

application package and required data. 

In reviewing applications for pesticide 

product registration under FIFRA, EPA 

must determine, among other things, 

whether the pesticide generally causes 

unreasonable adverse effects on the 

environment when used in accordance 

with widespread and commonly 

recognized practice. If EPA determines 

that a pesticide product meets the 

registration standard of FIFRA section 

3(c), EPA registers (or licenses) the 

product for distribution and sale in the 

United States (U.S.). Pesticides must be 

registered or exempted by EPA’s Office 

of Pesticide Programs before they may 

be sold or distributed in the U.S. Once 

registered, a pesticide may not legally be 

used unless the use is consistent with 

the approved directions for use on the 

pesticide’s label or labeling. 

B. Data Requirements 

FIFRA section 3(c)(2) directs EPA to 

publish guidelines specifying the kinds 

of data that applicants and registrants 

must submit to support EPA regulatory 

determinations under FIFRA. These 

data requirements are set forth in 40 

CFR part 158 and 40 CFR part 161. The 

data allow EPA to evaluate whether a 

pesticide has the potential to cause 

harmful effects on certain nontarget 

organisms and endangered species that 

include: Humans; wildlife; plants; and 

surface water or ground water. 

C. Satisfaction of Data Requirements 

EPA regulations in 40 CFR part 152, 

subpart E prescribe a variety of means 

by which applicants may satisfy EPA’s 

data requirements. These include 

submitting new studies, but they also 

allow an applicant to cite to data 

previously submitted by another person 

that are relevant to that applicant’s 

product. When the latter option is 

selected, an applicant may be required 

to either obtain permission or offer 

compensation to cite the data, 

depending upon whether the data at 

issue are subject to the exclusive use or 

data compensation provisions of FIFRA 

section 3(c)(1)(F). In addition, the 

regulations in 40 CFR part 152, subpart 

E spell out the circumstances under 

which certain applicants are exempt 

from data submission or citation 

obligations (i.e., the formulators’ 

exemption provided by FIFRA section 

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

D. Protection of Data Submitters’ Rights 

The bulk of the regulations in 40 CFR 

part 152, subpart E address those 

situations in which applicants for 

registration choose to satisfy data 

requirements by citation to existing data 

submitted by other persons. In that 

respect, the regulations prescribe: 

1. The means by which a pesticide 

data submitter can protect and 

document his/her exclusive use and 

compensation rights in data submitted 

to the Agency. Generally, persons 

submitting data must request inclusion 

on an Agency-maintained Data 

Submitters List as the means for 

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asserting their rights to offers of 

compensation from applicants who cite 

their data. 

2. Procedures that applicants who cite 

to data submitted by others must follow 

to ensure that data submitters’ rights are 

protected. The procedures apply to new 

and amended registrations, as well as 

maintenance of existing registrations 

under the reregistration and registration 

review programs. 

3. Procedures for the transfer of data 

rights to other persons. Data rights are 

separate from the registration of the 

pesticide, and therefore may be 

transferred to another person separate 

from the registration. 

4. The procedures that a data 

submitter may use to seek redress when 

the submitter believes he/she has been 

deprived of data rights accorded under 

FIFRA. 

III. Today’s Proposed Revisions 

EPA is proposing to update certain 

aspects of 40 CFR part 152, subpart E 

regulations governing satisfaction of 

data requirements and the associated 

data rights procedures. The regulations 

were promulgated in 1984 and have 

served satisfactorily since then. EPA 

has, however, identified the need to 

update the provisions to reflect changes 

in the statute and related practices over 

time. For example, the scope of the 

protections has expanded by statute to 

include both new protections and new 

decisions that are subject to data rights 

protection procedures, including 

reregistration under FIFRA section 4, 

and registration review under FIFRA 

section 3(g). In addition, EPA’s needs 

and practices have changed. 

A. Applicability (40 CFR 152.81 and 40 

CFR 152.46) 

EPA proposes to replace the limited 

listing of actions to which the subpart 

does not apply (excepted actions) with 

a single reference to actions that may be 

accomplished by notification or nonnotification under 40 CFR 152.46. EPA’s 

intention is first to simplify the 

exception provisions. At the same time, 

however, the revision highlights the 

underlying principle that an action that 

does not require scientific review of 

data also does not require satisfaction of 

data requirements, and is not subject to 

the requirements in 40 CFR part 152, 

subpart E. While the current regulation 

contains this proviso in 40 CFR 

152.81(b)(4)(xvi), the proposed revision 

gives prominence to this fundamental 

precept, and provides a firm basis for 

future determinations of the 

applicability of 40 CFR part 152, subpart 

E to specific actions. 

1. Applicability (40 CFR 152.81). 40 

CFR 152.81 describes the applicability 

of the provisions of subpart E to 

applications of various types, and more 

important to today’s proposal, those 

actions to which the procedures do not 

apply. Some actions are not covered by 

the provisions of FIFRA section 

3(c)(1)(F), including actions such as 

emergency exemptions under FIFRA 

section 18, experimental use permits 

under FIFRA section 5, and State 

registrations under FIFRA section 24(c). 

These exceptions would not change. 

However, the bulk of the exceptions 

listed in current 40 CFR 152.81(b) rely 

not on statutory exceptions, but on the 

principle that if EPA does not need to 

review scientific data in order to make 

its regulatory determinations, it need 

not require that applicants address the 

satisfaction of data requirements at all. 

Accordingly, current 40 CFR 152.81(b) 

identifies a detailed set of amendments 

to registration that do not require review 

of scientific data. These include, among 

other things, minor amendments to 

composition and labeling, deletion of 

uses, clarifications of labeling content 

and presentation, and other actions of 

an essentially administrative nature. 

The list was not intended to be allinclusive when promulgated, and is in 

fact only illustrative, given the wide 

variety of possible revisions to 

registration. EPA reserved the right to 

make determinations on the need for 

scientific data on a case-by-case basis, 

and either to require the procedures if 

scientific data are needed, or excuse the 

applicant from the procedures if 

scientific data are not needed (see 40 

CFR 152.81(b)(4) and 40 CFR 

152.81(b)(4)(xvi) respectively). 

2. Notifications and non-notifications 

(40 CFR 152.46). In a major 

restructuring of its procedural 

regulations in 1988, EPA introduced the 

concept of revisions to registration that 

could be accomplished by notification 

(40 CFR 152.46(a)) or non-notification 

(40 CFR 152.46(b)). Further, in 1996, 

those regulations were amended (61 FR 

33039, June 26, 1996) (FRL–5372–8) to 

permit the Agency to issue procedures 

(generally issued using Pesticide 

Registration (PR) Notices) to implement 

actions by notification or nonnotification. 

The notification and non-notification 

processes are intended to provide a 

streamlined means for registrants to 

make registration changes that have no 

potential to cause adverse effects. As the 

terms suggest, changes identified in 

these procedures may be accomplished 

without the need for Agency approval. 

EPA regards an action that will ‘‘have no 

potential to cause unreasonable adverse 

effects’’ as used in 40 CFR 152.46 as 

equivalent to a determination that no 

scientific data are needed to make the 

change within the meaning of 40 CFR 

152.81(b)(4)(xvi). In the latest PR Notice 

that addresses revisions that may be 

made by notification and nonnotification (i.e., PR Notice 98–10, 

October 22, 1998), EPA expanded the 

list of eligible actions considerably. 

Note that EPA has also permitted certain 

specific labeling changes to be made 

through notification or non-notification 

in other PR Notices (see, e.g., PR Notices 

2007–1 and 2008–1) and in case-by-case 

registration actions. 

3. Comparison of actions (40 CFR 

152.81 and 40 CFR 152.46). EPA has 

reviewed the list of actions in 40 CFR 

152.81(b)(4) against those permitted by 

notification or non-notification under 40 

CFR 152.46, as expressed in PR Notice 

98–10, to determine whether the 

changes are comparable. PR Notice 98– 

10 represents an additional 14 years of 

evolving Agency regulations and policy 

from the 1984 promulgation of 40 CFR 

152.81, and is considerably more 

detailed in its description of actions. 

Thus comparisons between the two are 

not exact. 

In a number of cases, the types of 

amendments excepted under 40 CFR 

152.81(b)(4) are covered by the 

provisions of 40 CFR 152.46, as 

expressed in PR Notice 98–10, and thus 

the proposed revision would have no 

effect on applications of those 

amendments (for example, minor 

changes in labeling having no 

substantive impact). In other cases, 

statutory, regulatory and policy changes 

since 1984 have resulted in excepted 

actions no longer being eligible for 

exception under 40 CFR 152.81(b). For 

example, addition or deletion of an 

active ingredient is now generally 

regarded as a new formulation requiring 

new registration. Finally, some types of 

excepted actions have been rendered 

moot as they are no longer treated as 

‘‘applications’’ for the purposes of 

subpart E, and are governed by other 

regulations (e.g., supplemental 

distribution, name and address changes, 

label splitting for marketing purposes). 

EPA regards the determinations under 

40 CFR 152.46, as expressed in PR 

Notice 98–10 and in other notices 

implementing notification or nonnotification procedures, as the Agency’s 

written finding under 40 CFR 

152.81(b)(4) as to whether scientific data 

(and thus compliance with subpart E) 

are required to evaluate an application. 

Today’s proposal simply articulates this 

principle in the text of the regulations. 

EPA will generally make these 

determinations in connection with its 

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review of applications. However, 

applicants and registrants may seek 

EPA’s determination as to whether 

subpart E procedures will apply to their 

actions in advance of submission of 

their applications. 

The proposed revision would broadly 

apply to future actions that EPA 

determines can be implemented through 

notification or non-notification 

procedures. Changes to the actions 

permitted by notification or nonnotification in the future may change 

the applicability of the procedures in 

subpart E. Excepted actions not 

addressed specifically in the regulation 

or that are not subject to notification 

and non-notification procedures would 

continue to be subject to subpart E 

unless EPA determines, on a case-bycase basis, that such actions do not 

require scientific review of data. 

Accordingly, EPA proposes to 

eliminate the limited listing in 40 CFR 

152.81 in favor of a reference to any 

action that may be implemented by the 

notification or non-notification 

procedures under 40 CFR 152.46. 

B. Update Definition of Exclusive Use 

Study (40 CFR 152.83) 

EPA proposes to update and 

restructure the existing definition of 

‘‘exclusive use study’’ to incorporate the 

additional exclusive use criteria added 

by the Food Quality Protection Act 

(1996). In that act, Congress expanded 

the exclusive use provisions of FIFRA 

section 3(c)(1)(F) in two circumstances: 

1. Congress amended section 

3(c)(1)(F)(ii) to allow for the extension 

of an original 10-year exclusive use 

provision for a period of up to an 

additional 3 years when the registrant 

adds minor uses meeting certain criteria 

to the original registration for which the 

exclusive use data were submitted. 

2. Congress added a new section 

3(c)(1)(F)(vi) that creates exclusive use 

rights in data submitted by an applicant 

or registrant to support an amendment 

adding a new use to an existing 

registration that does not retain any 

period of exclusive use, provided such 

data relate solely to a minor use of a 

pesticide. These provisions would be 

incorporated into the new definition. 

Because of the complexity of the new 

definition of exclusive use, EPA 

proposes to create a separate provision 

in the regulation to define ‘‘exclusive 

use study.’’ To do so, EPA proposes to 

move the existing definitions from 40 

CFR 152.83 into 40 CFR 152.82, and to 

add a new 40 CFR 152.83. 

C. When Materials Must Be Submitted 

(40 CFR 152.84) 

EPA proposes to revise 40 CFR 152.84 

to conform to the requirements of FIFRA 

section 33(f)(4) (as amended by the 

Pesticide Registration Improvement 

Renewal Act, Public Law 110–94, 

commonly called PRIA II). 

Current 40 CFR 152.84 allows an 

applicant to submit required 

documents, forms, and other materials 

related to satisfaction of data 

requirements at any time before the 

Agency approves the application, 

although it recommends submission at 

the time of application. Some of the 

required information must be submitted 

with the application, e.g., a request for 

waiver of a data requirement, because 

the Agency must make a determination 

as part of its review process. Other 

information has routinely been provided 

on forms supplied by the Agency, such 

as the Formulators’ Exemption 

Statement or the General Offer to Pay 

Statement, and typically is submitted 

with the application. 

Under FIFRA section 33(f)(4)(B), EPA 

must determine during the initial screen 

(within 21 days after receiving an 

application and the required registration 

service fee) that ‘‘the application 

contains all the necessary forms, data, 

and draft labeling, formatted in 

accordance with guidance published by 

the Administrator.’’ Information and 

forms required by subpart E pertaining 

to satisfaction of data requirements are 

covered by this provision. Furthermore, 

the Agency must reject applications that 

do not pass the initial 21-day content 

screen. Accordingly, the information 

and forms required by subpart E are no 

longer permitted to be submitted at any 

time prior to approval of the 

application, but must be submitted at 

the time of application. 

In addition to the above reasons, EPA 

believes that the primary rationale for 

the provision of 40 CFR 152.84 that 

allows applicants to satisfy subpart E 

requirements after submission of an 

application no longer exists. In the 

preamble to the existing regulations (49 

FR 30884, at 30897, August 1, 1984), 

EPA identified the 60-day waiting 

period for data gap certification letters 

as the primary example of timeconsuming activities that could unduly 

delay the submission of an application 

were applicants are required to submit 

completed subpart E materials at the 

time of submission of their applications. 

Because this proposed regulation will 

eliminate the requirement for applicants 

to send data gap letters in order to claim 

a data gap under the selective method 

of data support (see Unit III.G.), EPA 

sees no compelling reason for 

maintaining the existing provision even 

in the absence of the requirements of 

PRIA II. 

Accordingly, EPA proposes to revise 

40 CFR 152.84 to specify that the 

necessary forms and information 

pertaining to satisfaction of data 

requirements must be submitted at the 

time of application. 

D. Addition of Electronic Means of 

Contacting Data Submitters (40 CFR 

152.86 and 40 CFR 152.95) 

EPA proposes to revise 40 CFR 152.86 

and 40 CFR 152.95 to include the use 

of electronic methods of 

communication, such as e-mail, in 

addition to regular mail. This change 

would update communication methods 

between applicants. 

E. Selective Method (40 CFR 152.90) 

EPA proposes to eliminate the 

requirement that applicants use a 

Registration Standard as the default 

source of the listing of data 

requirements under the selective 

method in 40 CFR 152.90. 

Under the provisions of subpart E, an 

applicant may choose between two 

methods to address data compensation 

for cited data: Cite-all or selective. The 

cite-all method (40 CFR 152.86) permits 

an applicant to cite collectively all data 

in the Agency’s files that might pertain 

to his/her product, provided, among 

other things, the applicant certifies that 

he/she has obtained the original data 

submitter’s permission to cite any 

exclusive use data for the chemical, 

makes an offer to pay each person listed 

on the Data Submitters List for each 

active ingredient in his/her product and 

makes a general offer to pay other 

persons to the extent required by FIFRA 

section 3(c)(1)(F). The cite-all method, 

while easier to use and less burdensome 

procedurally, potentially subjects the 

applicant to an unknown or uncertain 

compensation liability. 

In contrast, under the selective 

method (40 CFR 152.90), an applicant 

must provide a list of data requirements 

that would apply to his/her product if 

it were being proposed for registration 

under FIFRA section 3(c)(5) for the first 

time, and must choose an acceptable 

method of satisfying each data 

requirement individually. If the 

applicant chooses to cite to existing data 

to satisfy an individual requirement, the 

applicant will need the permission of 

the original data submitter if the data 

are entitled to exclusive use treatment 

under FIFRA, or will need to make an 

offer to pay compensation to the original 

data submitter if the data are subject to 

the compensation provisions of FIFRA. 

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Because this method allows the 

applicant to select the data to be relied 

upon to meet EPA data requirements, 

the applicant under the selective 

method may thereby limit the scope of 

the required offers to pay. 

Currently, 40 CFR 152.90(a) requires 

that an applicant use an issued 

Registration Standard (the EPA 

reregistration decision documents 

issued prior to 1988) as the source of 

his/her list of data requirements for the 

selective method. If the Registration 

Standard does not address all required 

data or there is no Registration 

Standard, the applicant must refer to 40 

CFR part 158 data requirements as the 

alternate source of his/her list of data 

requirements. 

The form of EPA decision documents 

has evolved since the 1984 regulations 

were promulgated. Registration 

Standards were superseded beginning in 

1988 by Reregistration Eligibility 

Decision documents (REDs) as the 

Agency implemented the reregistration 

requirements of FIFRA section 4. In 

turn, REDs will likely be superseded or 

updated by determinations made under 

the new Registration Review program 

required by FIFRA section 3(g) and 40 

CFR part 155. Given the growth and 

evolution of the program’s systematic 

review of existing pesticides, EPA 

believes it should no longer identify by 

regulation a specific type of decision 

document as the source of data 

requirement listings. These documents 

are a snapshot of the data requirements 

at a particular review period, and are 

likely to become outdated over time as 

EPA’s risk assessments evolve and new 

types of data are needed. 

EPA also notes that on October 26, 

2007 ((72 FR 60934) (FRL–8106–5); (72 

FR 60988) (FRL–8109–8)), EPA 

significantly amended its data 

requirements in 40 CFR part 158 for 

conventional, biochemical and 

microbial pesticides. 40 CFR part 158 

and 40 CFR part 161 represent the most 

up-to-date iteration of data requirements 

for pesticides, and are likely to be 

updated in the future when appropriate 

to meet changing data needs. For 

example, EPA proposed revisions to the 

data requirements for antimicrobial 

pesticides (73 FR 59381, October 8, 

2008), and other amendments are under 

development. In general, EPA believes 

that the regulations in 40 CFR part 158 

and 40 CFR part 161 should be the 

primary source of the data listings 

needed for the selective method. 

Thus, EPA proposes to remove from 

40 CFR 152.90 the requirement that any 

specific Agency listing of data 

requirements serve as the basis for the 

selective method listing. Instead, EPA 

would refer applicants to the data 

requirements in 40 CFR part 158 and 40 

CFR part 161. 

Notwithstanding, consideration of 

existing decision documents such as 

REDs will continue to provide useful 

guidance to applicants and registrants in 

determining how EPA has applied the 

data requirements to individual 

products and uses. However, such 

documents do not represent a binding 

Agency determination regarding the 

data requirements that must be fulfilled 

to satisfy the requirements of any 

individual registration. 

F. Data Waivers (40 CFR 152.91) 

EPA proposes to make minor 

revisions in the data waiver provisions 

in the selective method in 40 CFR 

152.91 to conform to current policy 

concerning waivers, and to update them 

to accommodate Reregistration and 

Registration Review programs. 

When the regulations were initially 

promulgated, the Agency’s program for 

the systematic review and maintenance 

of existing registration was called the 

Registration Standards program, and the 

program had not fully matured. EPA 

anticipated that data waivers would be 

evaluated, granted and documented in 

the context of that program. 40 CFR 

152.91 allows an applicant to rely on a 

previously granted waiver that has been 

documented in a Registration Standard. 

As indicated previously, the 

Registration Standards program was 

replaced in 1988 by the reregistration 

program mandated by FIFRA section 4, 

which, in turn will be succeeded by the 

Registration Review program. These 

second- and third-generation pesticide 

review programs use different 

terminology for the decision documents 

that result. Applicants may rely on these 

later program documents to identify and 

document an existing waiver. 

Accordingly, EPA proposes to add 

Reregistration Eligibility and 

Registration Review decision documents 

as additional Agency records that 

applicants may refer to. This revision 

does not change the substance of the 

provision, as the current listing of 

applicable documents is merely 

illustrative. 

EPA also proposes to specify that a 

denial of a waiver decision is a final 

Agency action. Similar language is 

already included in the Agency’s 

regulations on waivers found in 40 CFR 

158.45, and this proposal would simply 

modify 40 CFR 152.91 to reflect the 

Agency’s existing position. 

G. Elimination of Certification and 

Documentation Procedures for Data 

Gaps (40 CFR 152.96) 

As touched upon in Unit III.E., when 

the regulations were initially 

promulgated in 1984, EPA was in the 

midst of establishing procedures for the 

review of existing registrations. The 

purpose of reregistration was to update 

and modernize the scientific database 

supporting pesticide registrations. At 

the time, EPA was also on the verge of 

promulgating for the first time the data 

requirements supporting registration. 

Shortly after subpart E was promulgated 

in August 1984, EPA promulgated a 

final rule on data requirements (October 

24, 1984; 49 FR 42881) (FRL–2591–5). 

In acknowledgement of the fact that 

many of these data requirements were to 

be satisfied during the reregistration 

process, the data compensation 

provisions of subpart E explicitly 

provide a procedure to satisfy a data 

requirement for which data have not yet 

been submitted—the data gap 

procedures in 40 CFR 152.96. In 

essence, an applicant can satisfy a data 

requirement by documenting that no 

data have been submitted to fulfill the 

data requirement. The applicant does so 

by writing to data submitters and 

requesting verification that they have 

not submitted data to satisfy the data 

requirement. Data submitters are not 

required to respond to such requests, 

but lose the right to later challenge the 

applicant’s data gap claim if they do not 

respond. 

As noted, however, the processes for 

review of existing pesticides have 

evolved significantly over the years, and 

most data gaps have been eliminated by 

the submission of data under the 

reregistration program. Few, if any, 

applicants can legitimately claim a data 

gap for a pesticide that has undergone 

reregistration. The absence or 

availability of data is evident because 

the data are likely to be listed in an 

Agency decision document such as a 

RED. Moreover, in EPA’s experience, 

the data gap procedures are rarely used, 

even when data gaps were much more 

common. 

Although there may be circumstances 

when an applicant may legitimately 

claim that a data gap exists, EPA 

believes the required data gap 

documentation process is no longer 

needed because: (1) As noted above, 

most data gaps have been eliminated; 

and (2) EPA is in a much better position 

today to evaluate the legitimacy of data 

gap claims because of its reregistration 

program. Consequently, EPA proposes 

to eliminate 40 CFR 152.96(b) and 40 

CFR 152.96(c). 

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EPA will continue to allow a claim of 

a data gap to satisfy an initial screen of 

an application, but will not require the 

submission of the certification of data 

gap procedures. EPA will also scrutinize 

such claims carefully, as it believes that 

few such claims can be supported given 

the significant amounts of data now 

available for most pesticides. EPA’s 

current regulations in 40 CFR 152.115(a) 

provide that any data requirement that 

remains legitimately unfulfilled at the 

time of registration is established as a 

condition of the registration under 

FIFRA section 3(c)(7), and the new 

registrant is required to fulfill the data 

requirement whenever existing 

registrants of similar products must do 

so. 

Under the proposed rule, a data 

submitter would no longer routinely 

receive requests from applicants to 

confirm a data gap. However, under 40 

CFR 152.119, EPA will make available 

30 days after registration the means by 

which an applicant satisfied the data 

requirements, including whether, under 

the selective method, the applicant 

claimed a data gap. A registrant thus has 

the means to ascertain whether he/she 

has submitted data that might fulfill a 

data requirement for which the 

applicant has claimed a data gap exists. 

Since EPA would no longer require 

the data gap procedures, EPA also 

proposes to revise the petition 

procedures in 40 CFR 152.99 such that 

a data submitter may petition for redress 

on the basis of a false or improper data 

gap claim rather than failure to comply 

with the data gap procedures. EPA also 

proposes to eliminate 40 CFR 152.97(b) 

(Obligation to respond to data gap 

letters) since that provision will serve 

no purpose with the elimination of the 

data gap letter procedure as proposed 

today. 

IV. FIFRA Mandated Reviews 

In accordance with FIFRA sections 

25(a) and (d), the Agency submitted a 

draft of this proposed rule to the 

Committee on Agriculture in the United 

States House of Representatives, the 

Committee on Agriculture, Nutrition, 

and Forestry in the United States 

Senate, the Secretary of Agriculture, and 

the FIFRA Scientific Advisory Panel 

(SAP). The SAP and the Secretary of 

Agriculture waived review of this 

proposed rule. 

V. Statutory and Executive Order 

Reviews 

A. Regulatory Review 

This action is not a ‘‘significant’’ 

regulatory action under the terms of 

Executive Order 12866 entitled 

Regulatory Planning and Review (58 FR 

51735, October 4, 1993), and is therefore 

not subject to review by the Office of 

Management and Budget (OMB) under 

Executive Order 12866. 

B. Paperwork Reduction Act 

The information collection activities 

related to the submission of data to EPA 

in order to register a pesticide product 

are already approved by OMB under the 

Paperwork Reduction Act (PRA) 44 

U.S.C. 3501 et seq. This action does not 

impose any new information collection 

burden. The information collection 

requirements, i.e., the paperwork 

collection activities, contained in this 

proposal are already approved by OMB 

under the following information 

collection requests (ICRs): 

1. The activities associated with the 

application for a new or amended 

registration of a pesticide are currently 

approved under OMB Control No. 2070– 

0060 (EPA ICR No. 0277). 

2. The activities associated with the 

generation of data for the Pesticide Data 

Call-In Program are currently approved 

under OMB Control No. 2070–0174 

(EPA ICR No. 2288.01). 

Copies of these OMB-approved ICRs 

may be obtained from Susan Aby, 

Collection Strategies Division; U.S. 

Environmental Protection Agency 

(2822T); 1200 Pennsylvania Ave., NW., 

Washington, DC 20460; or by calling 

(202) 566–1672. 

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. An agency 

may not conduct or sponsor, and a 

person is not required to respond to an 

information collection request unless it 

displays a currently valid OMB control 

number, or is otherwise required to 

submit the specific information by a 

statute. The OMB control numbers for 

EPA’s regulations, after appearing in the 

preamble of the final rule, are listed in 

40 CFR part 9 and 48 CFR chapter 15, 

and included on the related collection 

instrument (e.g., form or survey). EPA 

has determined that this proposed rule 

imposes no additional information 

collection and paperwork burden. 

These existing ICRs cover the 

paperwork activities contained in this 

proposal because these activities already 

occur as part of existing program 

activities. 

These program activities are an 

integral part of the Agency pesticide 

program and the corresponding ICRs are 

regularly renewed. The total estimated 

average annual public reporting burden 

currently approved by OMB for these 

various activities ranges from 8 hours to 

approximately 3,000 hours per 

respondent, depending on the activity 

and other factors surrounding the 

particular pesticide product. 

Comments are requested on the 

Agency’s need for this information, the 

accuracy of the burden estimates, and 

any suggested methods for minimizing 

respondent burden, including the use of 

automated collection techniques. Send 

comments to EPA as part of your overall 

comments on this proposed action in 

the manner specified in Unit I. In the 

final rule, the Agency will address any 

comments received regarding the 

information collection requirements 

contained in this proposal. 

B. Regulatory Flexibility Act 

Pursuant to section 605(b) of the 

Regulatory Flexibility Act (RFA), 5 

U.S.C. 601 et seq., after considering the 

potential economic impacts of this 

proposed rule on small entities, the 

Agency hereby certifies that this action 

will not have a significant adverse 

economic impact on a substantial 

number of small entities. 

Small entities include small 

businesses, small organizations, and 

small governmental jurisdictions. For 

purposes of assessing the impacts of 

today’s proposed rule on small entities, 

a small entity is defined as: (1) A small 

business as defined by the Small 

Business Administration’s (SBA) 

regulations at 13 CFR 121.201; (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 notfor-profit enterprise which is 

independently owned and operated and 

is not dominant in its field. 

This action will not have a significant 

economic impact on a substantial 

number of small entities. In determining 

whether a rule has a significant 

economic impact on a substantial 

number of small entities, the impact of 

concern is any significant adverse 

economic impact on small entities, 

since the primary purpose of the 

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regulatory flexibility analyses is to 

identify and address regulatory 

alternatives ‘‘which minimize any 

significant economic impact of the rule 

on small entities.’’ 5 U.S.C. 603 and 604. 

Thus, an agency may certify that a rule 

will not have a significant economic 

impact on a substantial number of small 

entities if the rule relieves regulatory 

burden, or otherwise has a positive 

economic effect on all of the small 

entities subject to the rule. 

EPA believes that this proposed rule 

would not have any adverse impacts on 

affected small entities, because it does 

not alter the scope of existing pesticide 

data submission or citation obligations. 

Further, small business entities already 

receive the benefit of the statutory 

‘‘formulators’ exemption’’ provision 

which exempts qualifying applicants 

and registrants from most data 

submission and citation obligations. No 

changes to this provision are proposed 

in this action. 

The proposed changes discussed in 

this document are expected to simplify 

the procedures and reduce burdens on 

certain data submitters. EPA has 

therefore concluded that this proposed 

rule will not have any adverse impacts 

on affected small entities. Of course 

EPA continues to be interested in the 

potential impacts of the procedures on 

small entities and welcome comments 

on issues related to such impacts. 

D. Unfunded Mandates Reform Act 

This action does not impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) Public Law 

104–4. Therefore, this action is not 

subject to the requirements of UMRA. 

E. Federalism 

Pursuant to Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999), EPA has determined 

that this proposed 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 

proposed rule. 

F. Tribal Implications 

Under Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000), EPA has 

determined that this proposed rule does 

not have tribal implications because it 

will not have any effect 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 proposed rule. 

G. Children’s Health Protection 

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 proposed rule because 

this action is not designated as an 

‘‘economically significant’’ regulatory 

action as defined by Executive Order 

12866 (see Unit V.A.), nor does this 

action establish an environmental 

standard that is intended to have a 

disproportionate effect on children. 

H. Energy Effects 

This proposed rule is not subject to 

Executive Order 13211, entitled Actions 

Concerning Regulations that 

Significantly Affect Energy Supply 

Distribution, or Use (66 FR 28355, May 

22, 2001), because this action is not 

expected to affect energy supply, 

distribution, or use. 

I. Technology Standards 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (NTTAA), Public Law 104– 

113, 12(d) (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 otherwise 

impractical. Voluntary consensus 

standards are technical standards (e.g., 

materials specifications, test methods, 

sampling procedures, and business 

practices) that are developed or adopted 

by voluntary consensus standards 

bodies. NTTAA directs EPA to provide 

Congress, through OMB, explanations 

when the Agency decides not to use 

available and applicable voluntary 

consensus standards. 

This proposed regulation does not 

involve technical standards. Therefore, 

EPA is not considering the use of any 

voluntary consensus standards. 

J. Environmental Justice 

This proposed rule does not involve 

special considerations of any 

environmental justice related issues as 

delineated by Executive Order 12898, 

entitled Federal Actions to Address 

Environmental Justice in Minority 

Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

List of Subjects in 40 CFR Part 152 

Environmental protection, 

Administrative practice and procedure, 

Pesticides and pests, Reporting and 

recordkeeping requirements. 

Dated: October 18, 2010. 

Lisa P. Jackson, 

Administrator. 

Therefore, it is proposed that 40 CFR 

part 152, subpart E, would be amended 

as follows: 

1. The authority citation for part 152 

continues to read as follows: 

Authority: 7 U.S.C. 136–136y; subpart U 

is also issued under 31 U.S.C. 9701. 

2. The title of subpart E is revised to 

read ‘‘Satisfaction of Data Requirements 

and Protection of Data Submitters’ 

Rights.’’ 

3. Section 152.81 is revised to read as 

follows: 

§ 152.81 Applicability. 

(a) Except as provided in paragraph 

(b) of this section, the requirements of 

this subpart apply to: 

(1) Each application for registration of 

a new product. 

(2) Each application for amended 

registration of a currently registered 

product. 

(3) Each submission in response to a 

Data Call-In under FIFRA section 

3(c)(2)(B) for an existing registration, 

including, but not limited to, a product 

subject to reregistration under FIFRA 

section 4 or registration review under 

FIFRA section 3(g). If the Data Call-In 

establishes procedures for protection of 

data submitters’ rights, recipients must 

comply with the specific requirements 

of the Data Call-In rather than the 

generic procedures set forth in §§ 152.85 

through 152.96. 

(b) This subpart E does not apply to 

any of the following: 

(1) An application for registration 

submitted to a State under FIFRA 

section 24(c). 

(2) An application for an experimental 

use permit under FIFRA section 5. 

(3) An application for an emergency 

exemption under FIFRA section 18. 

(4) A request for cancellation of a 

registration, or a request for deletion of 

one or more existing uses, in accordance 

with FIFRA section 6(f). 

(5) A modification to registration of a 

currently registered product that may be 

accomplished under the notification or 

non-notification provisions of § 152.46 

and any procedures issued thereunder. 

Notwithstanding the preceding 

sentence, compliance with this subpart 

is required if the Administrator has, by 

written notice under § 152.46, 

determined that the modification may 

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not be accomplished by notification or 

non-notification. 

(6) Any type of amendment if the 

Administrator determines, by written 

finding, that Agency consideration of 

data would not be necessary in order to 

approve the amendment under FIFRA 

section 3(c)(5). 

(7) Compliance with Agency 

regulations, adjudicatory hearing 

decisions, notices, or other Agency 

announcements that unless the 

registration is amended in the manner 

the Agency proposes, the product’s 

registration will be suspended or 

canceled, or that a hearing will be held 

under FIFRA section 6. However, this 

paragraph does not apply to 

amendments designed to avoid 

cancellation or suspension threatened 

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

because of failure to submit data. 

4. Section 152.83 is redesignated as 

§ 152.82 and the introductory text of 

newly redesignated § 152.82 is revised 

to read as follows: 

§ 152.82 Definitions. 

For the purposes of this subpart, the 

definitions set forth in the Federal 

Insecticide, Fungicide, and Rodenticide 

Act, in § 152.3, and in this section 

apply. In addition, the term ‘‘exclusive 

use study’’ shall have the meaning set 

forth in § 152.83. 

5. Section 152.83 is added, to read as 

follows: 

§ 152.83 Definition of exclusive use study. 

A study is an exclusive use study if 

it meets the conditions of either 

paragraph (a) or paragraph (b) of this 

section. 

(a) Initial exclusive use period. A 

study submitted to support the 

registration of a product containing a 

new active ingredient (new chemical) or 

new combination of active ingredients 

(new combination) is an exclusive use 

study if all the following conditions are 

met: 

(1) The study pertains to a new active 

ingredient (new chemical) or new 

combination of active ingredients (new 

combination) first registered after 

September 30, 1978. 

(2) The study was submitted in 

support of, or as a condition of approval 

of, the application resulting in the first 

registration of a product containing such 

new chemical or new combination, or 

an application to amend such 

registration to add a new use. 

(3) Less than 10 years have passed (or 

up to 13 years, if the period of exclusive 

use protection has been extended under 

FIFRA section 3(c)(1)(F)(ii)) since the 

issuance of the registration for which 

the data were submitted. 

(4) The study was not submitted to 

satisfy a data requirement imposed 

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

(b) Exclusive use period for certain 

minor use data. A study submitted by 

an applicant or registrant to support an 

amendment adding a new minor use to 

an existing registration that does not 

retain any period of exclusive use under 

paragraph (b)(1) of this section is an 

exclusive study under FIFRA section 

3(c)(1)(F)(vi) if all the following 

conditions are met: 

(1) The study relates solely to a minor 

use of a pesticide. 

(2) The applicant or registrant at the 

time the new use is requested has 

notified the Administrator that any 

exclusive use pesticide for the period 

has expired and that the study is eligible 

for exclusive use treatment. 

(3) Less than 10 years have passed 

since the study was submitted to EPA. 

(4) The study was not submitted to 

satisfy a data requirement imposed 

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

(5) The minor use supported by the 

data has not been voluntarily canceled 

nor have such data been used to support 

a non-minor use. 

6. Section 152.84 is revised to read as 

follows: 

§ 152.84 When materials must be 

submitted to the Agency. 

Information and materials required by 

this subpart must be submitted at the 

time of application, unless the 

application is determined not to be 

subject to the requirements of this 

subpart. 

7. Section 152.86 is amended by 

revising paragraph (b)(2)(iv) to read as 

follows: 

§ 152.86 The cite-all method. 

* * * * * 

(b) * * * 

(2) * * * 

(iv) The applicant’s name, address 

and contact information, including a 

telephone number and e-mail address. 

8. Section 152.90 is amended by 

revising the reference in the last 

sentence of the introductory text from 

‘‘demonstrating’’ to ‘‘claiming,’’ and by 

revising paragraphs (a) and (b)(6) to read 

as follows: 

§ 152.90 The selective method. 

* * * * * 

(a) List of data requirements. (1) Each 

applicant must submit a list of the data 

requirements that would apply to his/ 

her pesticide, its active ingredients, and 

its use patterns, if the product were 

being proposed for registration under 

FIFRA section 3(c)(5) for the first time. 

(2) The applicant must list the 

applicable requirements, as prescribed 

by part 158 of this chapter or part 161 

of this chapter, as applicable. All 

required (R) studies, and any studies 

that could be conditionally required 

(CR) based upon composition, use 

pattern, or the results of required 

studies, are to be listed. The applicant 

need not list data requirements 

pertaining to any ingredient which 

qualifies for the formulators’ exemption. 

(b) * * * 

(6) Claim of a data gap. Refer to 

§ 152.96. 

9. Section 152.91 is amended by 

revising paragraphs (a) and (c), to read 

as follows: 

§ 152.91 Waiver of a data requirement. 

* * * * * 

(a) Request for extension of an 

existing waiver. An applicant may claim 

that a waiver previously granted by the 

Agency also applies to a data 

requirement for his/her product. To 

document this claim, the applicant must 

provide a reference to the Agency record 

that describes the previously granted 

waiver, such as an Agency list of 

waivers or an applicable Registration 

Standard, Reregistration Eligibility 

Decision document or Registration 

Review decision document, and explain 

why that waiver should apply to his/her 

product. 

* * * * * 

(c) Effect of denial of waiver request. 

A decision by the Agency to deny a 

written request for a new waiver or an 

extension of an existing waiver is a final 

Agency action. Following denial, the 

applicant must choose another method 

of satisfying the data requirement. 

10. Section 152.95 is amended by 

revising the introductory text and by 

revising paragraph (b)(2)(v), to read as 

follows: 

§ 152.95 Citation of all studies in the 

Agency’s files pertinent to a specific data 

requirement. 

An applicant normally may 

demonstrate compliance for a data 

requirement by citation of all studies in 

the Agency’s files pertinent to that data 

requirement. The applicant who selects 

this cite-all option must submit to the 

Agency: 

* * * * * 

(b) * * * 

(2) * * * 

(v) The applicant’s name, address and 

contact information, including a 

telephone number and e-mail address. 

* * * * * 

11. Section 152.96 is revised to read 

as follows: 

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§ 152.96 Claim of data gap. 

(a) When a data gap may be claimed. 

Except as provided in paragraph (b) of 

this section, an applicant may defer his/ 

her obligation to satisfy an applicable 

data requirement until the Agency 

requires the data if no other person has 

previously submitted to the Agency a 

valid study that would satisfy the data 

requirement in question. 

(b) When a data gap may not be 

claimed—(1) Product containing a new 

active ingredient. An applicant for 

registration of a product containing a 

new active ingredient may not defer his/ 

her obligation by claiming a data gap 

unless he/she can demonstrate to the 

Agency’s satisfaction that the data 

requirement was imposed so recently 

that insufficient time has elapsed for the 

study to have been completed and that, 

in the public interest, the product 

should be registered during the limited 

period of time required to complete the 

study. Refer to FIFRA section 3(c)(7)(C). 

(2) Product not containing a new 

active ingredient. An applicant for 

registration of a product under FIFRA 

section 3(c)(7)(A) or (B) (a product not 

containing a new active ingredient) may 

not defer his/her obligation by claiming 

a data gap if the data are: 

(i) Data needed to determine whether 

the product is identical or substantially 

similar to another currently registered 

product or differs only in ways that 

would substantially increase the risk of 

unreasonable adverse effects on the 

environment. 

(ii) Efficacy data specific to the 

product, if required to be submitted to 

the Agency. 

(iii) If a new use is proposed for a 

product that is identical or substantially 

similar to an existing product, data to 

demonstrate whether the new use 

would substantially increase the risk of 

unreasonable adverse effects on the 

environment. 

(c) Approval of application with a 

data gap claim. (1) In accordance with 

§ 152.115(a), any registration that is 

approved based upon a data gap claim 

shall be conditioned on the submission 

of the data no later than the time that 

the data are required to be submitted for 

similar products already registered. 

(2) Notwithstanding paragraph (c)(1) 

of this section, the Agency will not 

approve an application if it determines 

that the data for which a data gap claim 

has been made are needed to determine 

if the product meets the requirements of 

FIFRA section 3(c)(5) or 3(c)(7). 

12. Section 152.97 is revised to read 

as follows: 

§ 152.97 Rights and obligations regarding 

the Data Submitters List. 

(a) Each original data submitter shall 

have the right to be included on the 

Agency’s Data Submitters List. 

(b) Each original data submitter who 

wishes to have his/her name added to 

the current Data Submitters List must 

submit to the Agency the following 

information: 

(1) Name and current address. 

(2) Chemical name, common name (if 

any) and CAS number (if any) of the 

active ingredient(s), with respect to 

which he/she is an original data 

submitter. 

(3) For each such active ingredient, 

the type(s) of study he/she has 

previously submitted (identified by 

reference to data/information 

requirements listed in part 158 of this 

chapter or part 161 of this chapter as 

applicable), the date of submission, and 

the EPA registration number, file 

symbol, or other identifying reference 

for which it was submitted. 

(c) Each applicant not already 

included on the Data Submitters List for 

a particular active ingredient must 

inform the Agency at the time of 

submission of a relevant study whether 

he/she wishes to be included on the 

Data Submitters List for that pesticide. 

13. Section 152.99 is amended by 

removing paragraph (a)(2)(iv), 

redesignating paragraphs (a)(2)(v) and 

(a)(2)(vi) as (a)(2)(iv) and (a)(2)(v), and 

revising newly redesignated paragraph 

(a)(2)(iv) to read as follows: 

§ 152.99 Petitions to cancel registration. 

* * * * * 

(a) * * * 

(2) * * * 

(iv) The applicant has falsely or 

improperly claimed that a data gap 

existed at the time of his/her 

application. 

[FR Doc. 2010–27906 Filed 11–4–10; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 450 

[EPA–HQ–OW–2010–0884; FRL–9222–3] 

Proposed Rule Staying Numeric 

Limitation for the Construction and 

Development Point Source Category 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA is proposing to stay the 

numeric effluent limitation of 280 NTU 

and associated monitoring requirements 

for the Construction and Development 

Point Source Category. This action is 

necessary so that EPA can reconsider 

the record basis for calculating the 

numeric effluent limitation. EPA plans 

to take final action to recalculate the 

numeric effluent limitation by June 29, 

2011. EPA proposes to stay the 280 NTU 

limit and associated monitoring 

requirements until it takes final action 

to recalculate the numeric limitation. 

DATES: Comments must be received on 

or before December 6, 2010. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–HQ– 

OW–2010–0884, by one of the following 

methods: 

• http://www.regulations.gov: This is 

EPA’s preferred approach, although you 

may use the alternatives presented 

below. Follow the on-line instructions 

for submitting comments. 

• E-mail: OW-Docket@epa.gov. 

• Mail: USEPA Docket Center, 

Environmental Protection Agency, 

Docket Number EPA–HQ–OW–2010– 

0884, Mailcode 2822T, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460. 

• Hand Delivery: USEPA Docket 

Center, Public Reading Room, 1301 

Constitution Ave., NW., Room 3334, 

EPA West Building, Washington, DC 

20004. Such deliveries are only 

accepted during the Docket’s normal 

hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–OW–2010– 

0884. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 

that is placed in the public docket and 

made available on the Internet. If you 

submit an electronic comment, EPA 

recommends that you include your 

mstockstill on DSKH9S0YB1PROD with PROPOSALS