17560 Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2007–1080; FRL–8399–9] 

RIN 2070–AD61 

Endocrine Disruptor Screening 

Program; Policies and Procedures for 

Initial Screening 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: This document describes the 

policies and procedures EPA generally 

intends to adopt for initial screening of 

chemicals under the Endocrine 

Disruptor Screening Program (EDSP). 

The EDSP is established under section 

408(p) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), which requires 

endocrine screening of all pesticide 

chemicals and was established in 

response to growing scientific evidence 

that humans, domestic animals, and fish 

and wildlife species have exhibited 

adverse health consequences from 

exposure to environmental chemicals 

that interact with their endocrine 

systems. In December 2007, EPA sought 

comment on its draft policies and 

procedures for initial screening under 

the EDSP. Following review and 

revision based on the public comments, 

EPA is now describing the specific 

details of the policies and procedures 

that EPA generally intends to adopt for 

initial screening under the EDSP, 

including the statutory requirements 

associated with and format of the test 

orders, as well as EPA’s procedures for 

fair and equitable sharing of test costs 

and handling confidential data. 

FOR FURTHER INFORMATION CONTACT: 

William Wooge, Office of Science 

Coordination and Policy (OSCP), 

Mailcode 7201M, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (202) 564– 

8476; fax number: (202) 564–8482; email address: wooge.william@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, manufacture, 

use, or import pesticide/agricultural 

chemicals and other chemical 

substances; or if you are or may 

otherwise be involved in the testing of 

chemical substances for potential 

endocrine effects. Potentially affected 

entities, identified by the North 

American Industrial Classification 

System (NAICS) codes, may include, but 

are not limited to: 

• Chemical manufacturers, importers 

and processors (NAICS code 325), e.g., 

persons who manufacture, import or 

process chemical substances. 

• Pesticide, fertilizer, and other 

agricultural chemical manufacturing 

(NAICS code 3253), e.g., persons who 

manufacture, import or process 

pesticide, fertilizer and agricultural 

chemicals. 

• Scientific research and 

development services (NAICS code 

5417), e.g., persons who conduct testing 

of chemical substances for endocrine 

effects. 

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. To determine whether you 

or your business may be affected by this 

action, you should carefully examine 

the applicability provisions in Unit 

IV.E. of this document, and examine 

section 408(p) of the FFDCA. If you 

have any questions regarding the 

applicability of this action to a 

particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

B. How Can I Get Copies of this 

Document and Other Related 

Information? 

1. Docket. EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2007–1080. All documents in the 

docket are listed in the docket’s index 

available at http://www.regulations.gov. 

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

electronically at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

Federal holidays. The telephone number 

of the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

2. Electronic access. In addition to 

accessing the public docket for this 

document through www.regulations.gov, 

you can access other information about 

the EDSP through the Agency’s website 

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

oscpendo/index.htm. You may also 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

II. Overview 

A. What Action is the Agency Taking? 

Following review of public comments 

received on the Draft Policy and 

Procedures in response to the Federal 

Register notice of December 13, 2007 

(72 FR 70842) (FRL–8340–3), EPA is 

describing the policies and procedures 

it generally intends to use to issue and 

enforce orders pursuant to the authority 

provided by section 408(p)(5) of the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). This document provides 

specific details on the requirements 

associated with section 408(p) of 

FFDCA, format of the orders, and the 

associated Agency policies and 

procedures. This document also 

describes the actions and/or procedures 

that EPA intends to use to: 

• Minimize duplicative testing (see 

Unit IV.C.). 

• Promote fair and equitable sharing 

of test costs (see Unit IV.C.). 

• Address issues surrounding data 

compensation (see Unit IV.C.) and 

confidentiality (see Unit IV.D.). 

• Determine to whom orders would 

generally be issued (see Unit IV.E.). 

• Identify how order recipients 

should respond to FFDCA section 

408(p) test orders, including procedures 

for challenging the orders (see Unit IV.F. 

and H.). 

• Ensure compliance with FFDCA 

section 408(p) test orders (see Unit 

IV.G.). 

This document only addresses the 

procedural framework applicable to 

EPA’s implementation of FFDCA 

section 408(p)(5), and it does not 

address the tests or assays that will be 

used to screen chemicals for their 

potential to interact with the endocrine 

system or the approach for selecting 

chemicals under the EDSP. Elsewhere in 

today’s Federal Register, the Agency is 

publishing a document that presents the 

final list of the first group of chemicals 

to undergo Tier 1 screening. 


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Attachment B
Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices 17561 

B. Does this Document Contain Binding 

Requirements? 

This document describes the 

administrative policies and procedures 

that EPA generally intends to use in 

implementing the EDSP for initial 

screening. While the requirements in 

the statutes and the orders are binding 

on EPA and the order recipients, this 

document does not impose any binding 

requirements. Although EPA tried to 

develop policies that could be used in 

subsequent data collection efforts, these 

policies may be modified in response to 

the Agency’s experience during initial 

screening. The policies outlined in this 

document are intended to further the 

general goals of the program, and to the 

extent the policies need to be amended 

to further those programmatic goals, 

EPA may do so. The policies and 

procedures presented in this document 

are not intended to be binding on either 

EPA or any outside parties, and EPA 

may depart from the policies and 

procedures presented in this document 

where circumstances warrant and 

without prior notice. 

C. What is the Endocrine Disruptor 

Screening Program (EDSP)? 

The EDSP was established in 1998 to 

carry out the mandate in section 408(p) 

of the FFDCA (21 U.S.C. 346a et. seq.), 

which directed EPA ‘‘to develop a 

screening program . . . to determine 

whether certain substances may have an 

effect in humans that is similar to an 

effect produced by a naturally occurring 

estrogen, or such other endocrine effect 

as the Administrator may designate.’’ If 

a substance is found to have an 

endocrine effect on humans, FFDCA 

section 408(p)(6) directs the 

Administrator to take action under 

available statutory authority to ensure 

protection of public health. That is, the 

ultimate purpose of the EDSP is to 

provide information to the Agency that 

will allow the Agency to evaluate the 

risks associated with the use of a 

chemical and take appropriate steps to 

mitigate any risks (Ref. 1). The 

necessary information includes 

identifying any adverse effects that 

might result from the interaction of a 

substance with the endocrine system 

and establishing a dose-response curve 

(Ref. 1). Section 1457 of the Safe 

Drinking Water Act (SDWA) also 

authorizes EPA to screen substances 

that may be found in sources of drinking 

water, and to which a substantial 

population may be exposed, for 

endocrine disruption potential. (42 

U.S.C. 300j–17). 

The Agency first proposed the basic 

components of the EDSP on August 11, 

1998 (63 FR 42852) (FRL–6021–3). After 

public comments, external consultations 

and peer review, EPA provided 

additional details on December 28, 1998 

(63 FR 71542) (FRL–6052–9). The 

design of the EDSP was based on the 

recommendations of the Endocrine 

Disruptor Screening and Testing 

Advisory Committee (EDSTAC), which 

was chartered under the Federal 

Advisory Committee Act (FACA) (5 

U.S.C. App.2, 9(c)). The EDSTAC was 

comprised of members representing the 

commercial chemical and pesticides 

industries, Federal and State agencies, 

worker protection and labor 

organizations, environmental and public 

health groups, and research scientists. 

EDSTAC recommended that EPA’s 

program address both potential human 

and ecological effects; examine effects 

on estrogen, androgen, and thyroid 

hormone-related processes; and include 

non-pesticide chemicals, contaminants, 

and mixtures in addition to pesticides 

(Ref. 1). In addition, because of the large 

number of chemicals that might be 

included in the program, EDSTAC also 

recommended that EPA establish a 

priority-setting approach for choosing 

chemicals to undergo Tier 1 screening. 

The Science Advisory Board (SAB)/ 

Scientific Advisory Panel Subcommittee 

further recommended that initial 

screening be limited to 50 to 100 

chemicals. 

Based on the EDSTAC 

recommendations, EPA developed a 

two-tiered approach to implement the 

statutory testing requirements. The 

purpose of Tier 1 screening (referred to 

as ‘‘screening’’) is to identify substances 

that have the potential to interact with 

the estrogen, androgen, or thyroid 

hormone systems using a battery of 

assays. The fact that a substance may 

interact with a hormone system, 

however, does not mean that when the 

substance is used, it will cause adverse 

effects in humans or ecological systems. 

The purpose of Tier 2 testing (referred 

to as ‘‘testing’’), is to identify and 

establish a dose-response relationship 

for any adverse effects that might result 

from the interactions identified through 

the Tier 1 assays (Ref. 1). 

EPA is implementing its EDSP in 

three major parts developed in parallel. 

This document deals only with one 

component of the EDSP (i.e., the 

administrative policies and procedures 

related to the issuance of Tier 1 Orders). 

The three parts are briefly summarized 

as follows: 

1. Assay validation. Under FFDCA 

section 408(p), EPA is required to use 

‘‘appropriate validated test systems and 

other scientifically relevant 

information’’ to determine whether 

substances may have estrogenic effects 

in humans or other endocrine effects as 

the Administrator may designate. 

Validation is defined as the process by 

which the reliability and relevance of 

test methods are evaluated for the 

purpose of supporting a specific use 

(Ref. 2). The proposed EDSP Tier 1 

Screening Battery of Assays was 

presented to the FIFRA SAP during a 

public meeting on March 25–27, 2008. 

The FIFRA SAP report covering the 

meeting is available at http:// 

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

2008/march/minutes2008-03-25.pdf. 

The final Tier 1 battery will be 

announced in a separate Federal 

Register document that the Agency 

anticipates issuing in spring 2009. EPA 

is also in the process of developing and 

validating Tier 2 tests. The status of 

each assay can be viewed on the EDSP 

website in the Assay Status table: http:// 

www.epa.gov/scipoly/oscpendo/pubs/ 

assayvalidation/status.htm. 

2. Priority setting. EPA described its 

priority setting approach to select 

pesticide chemicals for initial screening 

on September 27, 2005 (70 FR 56449) 

(FRL–7716–9), and announced the draft 

list of initial pesticide active ingredients 

and pesticide inerts to be considered for 

screening under FFDCA on June 18, 

2007 (72 FR 33486) (FRL–8129–3). The 

first group of pesticide chemicals to 

undergo screening is also referred to as 

‘‘initial screening’’ in this document. 

The Agency is publishing in today’s 

Federal Register a final list of chemicals 

that will be subject to initial screening. 

EPA anticipates that it may, in the 

future, modify its approach to selecting 

chemicals for screening. Information 

and factors that EPA may consider in 

selecting chemicals could include: 

Public input; the results of testing 

chemicals on the initial list; 

management considerations to increase 

the integration of screening with other 

regulatory activities within the Agency; 

implementation considerations flowing 

from a decision to extend screening to 

additional categories of chemicals (e.g., 

non-pesticide chemical substances); and 

the availability of new priority setting 

tools (e.g., High Throughput Prescreening or Quantitative Structure 

Activity Relationships models). More 

information on EPA’s priority setting 

approach and the list of chemicals is 

available at http://www.epa.gov/scipoly/ 

oscpendo/pubs/prioritysetting. 

3. Procedures. This Federal Register 

document describes the administrative 

policies and procedures that EPA 

generally intends to use in 

implementing the EDSP for initial 

screening. Specifically, the general 

policies and procedures relating to: 


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• The issuance of FFDCA 408(p) 

testing orders. 

• Responses and related activities for 

order recipients to use in responding to 

an order. 

• Joint data development, cost 

sharing, data compensation, and data 

protection. 

• Other related procedures or 

policies. 

D. What Chemicals May Be Covered by 

the EDSP? 

FFDCA section 408(p)(3) specifically 

requires that EPA ‘‘shall provide for the 

testing of all pesticide chemicals.’’ 

Section 201 of FFDCA defines 

‘‘pesticide chemical’’ as ‘‘any substance 

that is a pesticide within the meaning of 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), including all 

active and pesticide inert ingredients of 

such pesticide.’’ (FFDCA section 

201(q)(1), 21 U.S.C. 231(q)(1) (Note that 

section 201(q) contains certain minor 

exceptions that do not affect these 

policies and procedures.)). Active 

ingredients are the substances that 

prevent, repel, suppress, control or kill 

the target pests. (FIFRA section 2(a); 7 

U.S.C. 136(a)) Pesticide inert ingredients 

(also referred to as ‘‘other pesticide 

ingredients’’) are any ingredients in a 

pesticide product that are not active. 

(FIFRA section 2(m); 7 U.S.C. 136(m)). 

Pesticide inert ingredients may simply 

dilute the active ingredient or they may 

perform some function such as allowing 

the product to adhere better to leaves or 

other surfaces to improve contact with 

the pests. Pesticide inert ingredients 

also include fragrances, which may 

mask the smell of residential pesticides, 

and odorizers, which may act as 

warning agents. Many of these 

chemicals, including both pesticide 

active and inert ingredients, also have 

other, non-pesticidal uses. 

FFDCA also provides EPA with 

discretionary authority to ‘‘provide for 

the testing of any other substance may 

have an effect that is cumulative to an 

effect of a pesticide chemical if the 

Administrator determines that a 

substantial population may be exposed 

to such a substance.’’ (21 U.S.C. 

346a(p)(3)). 

In addition, EPA may provide for the 

testing of ‘‘any other substance that may 

be found in sources of drinking water if 

the Administrator determines that a 

substantial population may be exposed 

to such substance.’’ (SDWA section 

1457, 42 U.S.C. 300j–17). 

Lastly, it is important to clarify that 

the procedures and policies described in 

this document do not in any way limit 

the Agency’s use of other authorities or 

procedures to require testing of 

chemicals for endocrine disruptor 

effects. For example, section 4 of the 

Toxic Substances Control Act (TSCA) 

provides EPA with the authority to 

require testing of TSCA chemical 

substances, provided that the Agency 

makes certain risk and/or exposure 

findings. (15 U.S.C. 2603). Similarly, 

section 3(c)(2)(B) of FIFRA grants EPA 

the authority to require pesticide 

registrants to submit additional data that 

EPA determines are necessary to 

maintain an existing registration. (7 

U.S.C. 136a(c)(2)(B)). 

As discussed in EPA’s priority setting 

approach for the EDSP (70 FR 56449, 

September 27, 2005), the Agency is 

initially focusing its chemical selection 

on pesticide chemicals, both active 

ingredients and high production volume 

chemicals used as a pesticide inert 

ingredient in pesticides. If chemicals 

identified for future screening and 

testing under the EDSP are not used in 

pesticides, the Agency intends to 

consider whether the policies and 

procedures identified in this document 

would be appropriate for other 

categories of substances. 

E. How Will EDSP Data be Used? 

In general, EPA intends to use the 

data collected under the EDSP, along 

with other information, to determine if 

a pesticide chemical, or other 

substances, may pose a risk to human 

health or the environment due to 

disruption of the endocrine system. The 

determination that a chemical does or is 

not likely to have the potential to 

interact with the endocrine system (i.e., 

disruption of the estrogen, androgen, or 

thyroid hormone systems) will be made 

on a weight-of-evidence basis taking 

into account data from the Tier 1 assays 

and/or other scientifically relevant 

information. 

Chemicals that go through Tier 1 

screening and are found to have the 

potential to interact with the estrogen, 

androgen, or thyroid hormone systems 

will proceed to the next stage of the 

EDSP where EPA will determine which, 

if any, of the Tier 2 tests are necessary 

based on the available data. Tier 2 

testing is designed to identify any 

adverse endocrine-related effects caused 

by the substance, and establish a 

quantitative relationship between the 

dose and that endocrine effect. 

III. Authority 

A. What is the Statutory Authority for 

the Policies Discussed in this 

Document? 

FFDCA section 408(p)(1) requires EPA 

‘‘to develop a screening program, using 

appropriate validated test systems and 

other scientifically relevant information 

to determine whether certain substances 

may have an effect in humans that is 

similar to an effect produced by a 

naturally occurring estrogen, or such 

other effects as [EPA] may designate.’’ 

(21 U.S.C. 346a(p)). 

FFDCA section 408(p)(3) expressly 

requires that EPA ‘‘shall provide for the 

testing of all pesticide chemicals.’’ 

FFDCA section 201 defines ‘‘pesticide 

chemical’’ as ‘‘any substance that is a 

pesticide within the meaning of the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA), including all 

active and pesticide inert ingredients of 

such pesticide.’’ (FFDCA section 

201(q)(1), 21 U.S.C. 231(q)(1)). The 

statute also provides EPA with 

discretionary authority to ‘‘provide for 

the testing of any other substance that 

may have an effect that is cumulative to 

an effect of a pesticide chemical if the 

Administrator determines that a 

substantial population may be exposed 

to such a substance.’’ (21 U.S.C. 

346a(p)(3)). 

FFDCA section 408(p)(5)(A) provides 

that the Administrator ‘‘shall issue an 

order to a registrant of a substance for 

which testing is required [under FFDCA 

section 408(p)], or to a person who 

manufactures or imports a substance for 

which testing is required [under FFDCA 

section 408(p)], to conduct testing in 

accordance with the screening program, 

and submit information obtained from 

the testing to the Administrator within 

a reasonable time period’’ that the 

Agency determines is sufficient for the 

generation of the information. 

FFDCA section 408(p)(5)(B) requires 

that, ‘‘to the extent practicable, the 

Administrator shall minimize 

duplicative testing of the same 

substance for the same endocrine effect, 

develop, as appropriate, procedures for 

fair and equitable sharing of test costs, 

and develop, as necessary, procedures 

for handling of confidential business 

information. . . .’’ (21 U.S.C. 346a 

(p)(5)(B)). 

If a registrant fails to comply with a 

FFDCA section 408(p)(5) test order, the 

Administrator is required to issue ‘‘a 

notice of intent to suspend the sale or 

distribution of the substance by the 

registrant. Any suspension proposed 

under this paragraph shall become final 

at the end of the 30–day period 

beginning on the date that the registrant 

receives the notice of intent to suspend, 

unless during that period, a person 

adversely affected by the notice requests 

a hearing or the Administrator 

determines that the registrant has 

complied fully with this paragraph.’’ (21 

U.S.C. 346a (p)(5)(C)). Any hearing is 

required to be conducted in accordance 


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with section 554 of the Administrative 

Procedures Act (APA). (5 U.S.C. 554). 

FFDCA section 408(p) explicitly 

provides that ‘‘the only matter for 

resolution at the hearing shall be 

whether the registrant has failed to 

comply with a test order under 

subparagraph (A) of this paragraph.’’ (21 

U.S.C. 346a (p)(5)(C)(ii)). A decision by 

the Administrator after completion of a 

hearing is considered to be a final 

Agency action. (21 U.S.C. 346a 

(p)(5)(C)(ii)). The Administrator shall 

terminate a suspension issued with 

respect to a registrant if the 

Administrator determines that the 

registrant has complied fully with 

FFDCA section 408(p)(5). (21 U.S.C. 

346a (p)(5)(C)(iii)). 

FFDCA section 408(p)(5)(D) provides 

that any person (other than a registrant) 

who fails to comply with a FFDCA 

section 408(p)(5) test order shall be 

liable for the same penalties and 

sanctions as are provided for under 

TSCA section 16. (21 U.S.C. 346a 

(p)(5)(D)). Such penalties and sanctions 

shall be assessed and imposed in the 

same manner as provided in TSCA 

section 16. Under section 16 of TSCA, 

civil penalties of up to $25,000 per day 

may be assessed, after notice and an 

administrative hearing held on the 

record in accordance with section 554 of 

the APA. (15 U.S.C. 2615(a)(1)–(2)(A)). 

B. Other Statutory Authorities Relevant 

to this Notice 

A number of other statutory 

provisions are discussed in this 

document, and consequently, are 

described below. This document does 

not reopen in any way or otherwise 

affect the existing policies or related 

procedures that have been established 

under these other provisions. The 

following is a brief summary of these 

other relevant authorities. 

1. FIFRA. FIFRA section 3(c)(1)(F) 

provides certain protections for people 

who submit data to EPA in connection 

with decisions under EPA’s pesticide 

regulatory program. Specifically, FIFRA 

section 3(c)(1)(F) confers ‘‘exclusive 

use’’ or ‘‘data compensation’’ rights on 

certain persons (‘‘original data 

submitters’’) who submit data (in which 

they have an ownership interest), in 

support of an application for 

registration, reregistration, or 

experimental use permit, or to maintain 

an existing registration. Applicants who 

cite qualifying data previously 

submitted to the Agency by the original 

data submitter must certify that the 

original data submitter has granted 

permission to the applicant to cite data 

or that the applicant has made an offer 

of compensation to the original data 

submitter. In the case of ‘‘exclusive use’’ 

data, the applicant must obtain the 

permission of the original data 

submitter and certify to the Agency that 

the applicant has obtained written 

authorization from the original data 

submitter. (Data are generally entitled to 

‘‘exclusive use’’ for 10 years after the 

date of the initial registration of a 

pesticide product containing a new 

active ingredient.) If data are not subject 

to exclusive use but are compensable, 

an applicant may cite the data without 

the permission of the original data 

submitter, so long as the applicant offers 

to pay compensation for the right to rely 

on the data. (Data are ‘‘compensable’’ for 

15 years after the date on which the data 

were originally submitted.) If an 

applicant and an original data submitter 

cannot agree on the appropriate amount 

of compensation, either may initiate 

binding arbitration to reach a 

determination. If an applicant fails to 

comply with either the statutory 

requirements or the provisions of a 

compensation agreement or an 

arbitration decision, the application or 

registration is subject to denial or 

cancellation. (See also 7 U.S.C. 136a 

(c)(1)(F)(ii)–(iii)). 

FIFRA section 3(c)(2)(B) provides 

that: 

. . . [i]f the Administrator determines that 

additional data are required to maintain in 

effect an existing registration of a pesticide, 

the Administrator shall notify all existing 

registrants of the pesticide to which the 

determination relates and provide a list of 

such registrants to any interested person. (7 

U.S.C. 136a(c)(2)(B)). 

Continued registration of a pesticide 

requires that its use not result in 

‘‘unreasonable adverse effects on the 

environment’’ defined as: 

. . . (1) any unreasonable risk to man or the 

environment, taking into account the 

economic, social, and environmental cost 

and benefits of the use of any pesticide, or 

(2) a human dietary risk from residues that 

results from a use of a pesticide in or on any 

food inconsistent with the standard under 

section 408 of the [FFDCA]. (7 U.S.C. 136 

(bb)). 

FIFRA section 3(c)(2)(B) contains a 

mechanism by which recipients of 

notices of data requirements (referred to 

as ‘‘Data Call-In notices’’ or ‘‘DCI 

notices’’) may jointly develop data and 

provides that ‘‘[a]ny registrant who 

offers to share in the cost of producing 

the data shall be entitled to examine and 

rely upon such data in support of 

maintenance of such registration.’’ The 

section establishes procedures to allow 

registrants who received DCI notices to 

use binding arbitration to resolve 

disputes about each person’s fair share 

of the testing costs. 

Further, FIFRA section 3(c)(1)(F) 

makes clear that data submitted under 

FIFRA section 3(c)(2)(B) are also 

‘‘compensable’’ when cited in support 

of an application for a registration. In 

other words, a pesticide company that 

chooses to rely on such data rather than 

develop its own data must offer 

compensation to the original data 

submitter–usually the data generator. 

Lastly, the Agency may suspend the 

registration of a pesticide if the 

registrant fails to take appropriate steps 

to provide data required under a DCI 

notice in a timely manner. 

Finally, FIFRA section 3(c)(2)(D) 

contains a provision, referred to as the 

‘‘formulator’s exemption’’ that is 

intended to simplify and promote equity 

in the implementation of the data 

compensation program under FIFRA 

section 3(c)(1)(F). This exemption 

relieves an applicant of the obligation to 

submit a study, or to cite and obtain 

permission or offer to pay data 

compensation to cite the results of a 

study if the study is relevant to the 

safety assessment of a registered product 

that the applicant buys from another 

person and uses to make the applicant’s 

product. Congress’ rationale for this 

exemption is that the seller will recover 

any data generation costs through the 

purchase price of its product. Thus, if a 

pesticide formulator applies to register a 

product containing an active ingredient 

that the formulator purchased from the 

basic manufacturer of the active 

ingredient, the formulator does not need 

to submit or cite and offer to pay 

compensation for any data specifically 

relevant to the purchased product. The 

Agency has extended the principles of 

the formulator’s exemption to data 

requirements under FIFRA section 

3(c)(2)(B). Consequently, if the 

formulator received a DCI notice 

requiring data on the active ingredient, 

the formulator could comply by 

providing documentation that it bought 

the active ingredient from another 

registrant. 

2. SDWA. SDWA section 1457 

provides EPA with discretionary 

authority to require testing, under the 

FFDCA section 408(p) screening 

program, ‘‘of any other substances that 

may be found in sources of drinking 

water if the Administrator determines 

that a substantial population may be 

exposed to such substance.’’ (42 U.S.C. 

300j–17). Because SDWA section 1457 

specifically mandates that EPA ‘‘may 

provide for testing. . . in accordance 

with the provisions of [FFDCA section 

408(p)],’’ EPA may rely on many of the 

procedures discussed in this document 

to require testing under SDWA section 

1457. 


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3. Other sections of FFDCA. FFDCA 

section 408(f) establishes procedures 

that the Agency ‘‘shall use’’ to require 

data to support the continuation of a 

tolerance or exemption that is in effect. 

The provision identifies three options: 

• Issuance of a notice to the person 

holding a pesticide registration under 

FIFRA section 3(c)(2)(B) (FFDCA section 

408(f)(1)(A)). 

• Issuance of a rule under section 4 

of TSCA (FFDCA section 408(f)(1)(B)). 

• Publication of a notice in the 

Federal Register requiring submission, 

by certain dates, of a commitment to 

generate the data ‘‘by one or more 

interested persons.’’ (FFDCA section 

408(f)(1)(C)). 

Before using the third option, 

however, EPA must demonstrate why 

the data ‘‘could not be obtained’’ using 

either of the first two options. FFDCA 

section 408(f)(1) expressly provides that 

EPA may use these procedures to 

‘‘require data or information pertaining 

to whether the pesticide chemical may 

have an effect in humans that is similar 

to an effect produced by a naturally 

occurring estrogen or other endocrine 

effects.’’ Finally, FFDCA section 

408(f)(1)(B) provides that, in the event 

of failure to comply with a rule under 

TSCA section 4 or an order under 

FFDCA section 408(f)(1)(C), EPA may, 

after notice and opportunity for public 

comment, modify or revoke any 

tolerance or exemption to which the 

data are relevant. 

In addition, FFDCA section 408(i) 

provides that ‘‘[d]ata that are or have 

been submitted to the Administrator 

under this section or FFDCA section 409 

in support of a tolerance or an 

exemption from a tolerance shall be 

entitled to confidential treatment for 

reasons of business confidentiality and 

to exclusive use and data compensation 

to the same extent provided by section 

3 and section 10 of [FIFRA].’’ 

IV. Policies and Procedures for Initial 

Screening Under the EDSP 

This Unit describes the policies and 

procedures that EPA generally intends 

to adopt for the initial screening 

required under the EDSP. In general, the 

Agency has tried to develop policies 

that could be used in subsequent data 

collection efforts, including those under 

SDWA. However, these policies and 

procedures may be modified as a result 

of the Agency’s experience applying 

them to the first chemicals to undergo 

screening and testing under the EDSP. 

In addition, EPA may modify these 

policies and procedures during the 

initial screening as circumstances 

warrant. 

A. Background 

On December 13, 2007 (72 FR 70842), 

EPA announced availability of and 

solicited public comment on EPA’s draft 

policies and procedures for initial 

screening under the EDSP. EPA held 

two public workshops, one on 

December 17, 2007, and another on 

February 28, 2008, to discuss the 

proposed policies and procedures with 

stakeholders. Following review and 

revision based on the public comments, 

EPA is now describing the specific 

details of the policies and procedures 

that EPA generally intends to use for 

initial screening under the EDSP. 

After reviewing all of the public 

comments received, EPA has decided to 

make some changes and/or clarifications 

to the draft policies and procedures. The 

Agency’s responses to public comments 

are discussed in more detail in the 

document entitled Response to 

Comments on the Endocrine Disruptor 

Screening Program: Draft Policies and 

Procedures for Initial Screening and 

Testing (Ref. 3), a copy of which is in 

the docket. The following is a 

discussion of the major changes and/or 

clarifications to the policies and 

procedures. 

1. Modified the response options for 

inerts. The Agency originally proposed 

to relieve a manufacturer or importer of 

a pesticide inert ingredient of the 

requirement to generate EDSP data only 

if the manufacturer or importer agreed 

to discontinue selling and distributing 

the ingredient for any use, whether the 

use was as a pesticide inert ingredient 

in a pesticide product or for a nonpesticidal purpose. As explained more 

fully in its Response to Comments 

document, after considering all of the 

comments, EPA is persuaded that it 

should change the EDSP initial 

screening policies and procedures and 

allow a manufacturer or importer to 

comply with an order by agreeing to 

discontinue sale of the chemical into the 

pesticide market. This change leads to 

other modifications to the procedures to 

ensure effective enforcement of data use 

protections as well as maintaining a 

‘‘level playing field.’’ 

Specifically, EPA intends to establish 

a Pesticide Inert Ingredients Data 

Submitters & Suppliers List (PIIDSSL) to 

identify any entity who has submitted 

compensable data on a pesticide inert 

ingredient in response to a test order 

issued under section 408(p). Pursuant to 

FIFRA section 3(c)(1)(F), when a new 

pesticide registration applicant’s 

product contains a pesticide inert 

ingredient on the PIIDSSL, EPA intends 

to require the applicant to identify the 

source of the pesticide inert ingredient. 

If the applicant’s source does not appear 

on the PIIDSSL, EPA intends to require 

the applicant either to switch to a 

source on the PIIDSSL; offer to pay 

compensation to the original data 

submitter(s) on the PIIDSSL; or generate 

their own data to support their 

application. 

The Agency also intends to continue 

to issue ‘‘catch-up’’ orders to any 

manufacturer or importer of a pesticide 

inert ingredient who enters the market 

place after EPA receives data in 

response to an initial test order for that 

ingredient. The Agency thinks that the 

combination of procedures–issuance of 

‘‘catch-up’’ orders and establishment of 

the PIIDSSL–will result in a system that 

effectively provides data use protections 

to generators of endocrine data on 

pesticide inert ingredients. EPA agrees 

that industry will have a strong interest 

in self-policing to ensure that 

competitors are not reneging on their 

commitment not to sell to the pesticide 

market and EPA accepts the 

commenters’ claims that the industry 

can effectively identify for EPA any 

companies that do not abide by a 

commitment to cease sales into the 

pesticide market. However, in the event 

that significant problems arise, EPA 

intends to reevaluate this policy, along 

with evaluating options for responding. 

For example, EPA considers that 

reexamination of this policy would be 

warranted if all manufacturers of a 

particular inert ingredient opted out of 

the pesticide market, given the likely 

impact this would have on end-use 

formulators. Another consideration 

would be if EPA discovers that these 

measures are ineffective at keeping the 

chemical out of the pesticide market. 

Under those circumstances, EPA may 

consider reissuing FFDCA section 

408(p) orders to the original 

manufacturers, with the requirement 

that the manufacturers and importers 

provide data in response to the order 

unless they agree to cease entirely all 

manufacture or importation of the 

chemical. EPA may also consider 

issuing orders to end-use registrants, if 

circumstances warrant. 

2. Catch-up orders. The Agency 

intends to issue ‘‘catch-up’’ orders for 

15 years after the initial test order(s) for 

the chemical is issued. 

3. Clarifications. The Agency has 

provided additional clarifications, 

including the policies and statutory 

interpretations relating to preenforcement review and informal 

administrative review, and the 

procedures related to the citation or 

submission of other scientifically 

relevant information. 


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4. Paperwork activities and estimates. 

The Agency has also revised the Initial 

Response Form and the templates for 

Tier 1 Orders, as well as the related 

estimated paperwork burden and costs. 

B. Testing of Pesticide Chemicals Under 

the EDSP 

For the initial screening, EPA 

generally intends to issue ‘‘Tier 1 

Orders’’ pursuant to section 408(p)(5) of 

FFDCA. This is consistent with the 

December 1998 Notice, where EPA 

indicated that it intended to rely 

primarily on FFDCA and SDWA to 

require testing, and would ‘‘use other 

testing authorities under FIFRA and 

TSCA to require the testing of those 

chemical substances that the FFDCA 

and SDWA do not cover.’’ (Ref. 1). 

Because EPA is focusing on pesticide 

chemicals in registered pesticide 

products for initial screening, there is 

no need to rely on TSCA or SDWA. 

However, as discussed in Unit IV.C.– 

IV.D., in order to address some of the 

more complex issues surrounding joint 

data development and the availability of 

data compensation and data protection, 

EPA intends to issue some orders jointly 

under the authority of FFDCA section 

408(p)(5) and FIFRA section 3(c)(2)(B). 

A diagram that graphically depicts the 

overall process is available in the 

docket. 

The Agency has developed two 

templates for the Tier 1 Orders that 

reflect the policies and procedures 

discussed in this document, and which 

outline the basic framework that EPA 

generally intends to use to issue orders 

for the EDSP initial screening. The test 

orders differ according to whether the 

recipient is a: (1) Pesticide registrant, or 

(2) manufacturer and/or importer of a 

pesticide inert ingredient (aka ‘‘other 

ingredient’’). In addition, the templates 

accommodate differences in the 

Agency’s procedures for data 

compensation, and for the minimization 

of duplicative data, which varies based 

on the Order recipient. Copies of the 

Tier 1 Order templates are included in 

the docket. 

There are some pesticide active and 

pesticide inert ingredients that are not 

registered in the U.S. but for which 

there are tolerances on foods imported 

from other countries. When these 

chemicals are to be tested in the future, 

EPA may rely on FFDCA 408(f)(1) to 

require ‘‘interested persons’’ to submit 

data for the EDSP. 

C. What is EPA Doing To Minimize 

Duplicative Testing and Promote Cost 

Sharing and Data Compensation Under 

EDSP? 

One of the complex issues discussed 

in the December 1998 Notice related to 

joint data development, and how EPA 

would implement the FFDCA section 

408(p)(5)(B) directive that ‘‘[t]o the 

extent practicable, the Administrator 

shall minimize duplicative testing of the 

same substance for the same endocrine 

effect. . . .’’ As noted in the December 

1998 Notice (63 FR 71563), EPA 

originally contemplated that it would 

adopt new procedures unique to the 

EDSP. 

After considering public comment on 

its 2007 Draft Policies and Procedures 

(72 FR 70842), EPA is adopting an 

approach that follows closely the draft 

procedures to promote cost sharing and 

data compensation described in the 

December 2007 document. 

EPA’s approach to ‘‘minimize 

duplicative testing of the same 

substance’’ and to promote the ‘‘fair and 

equitable sharing of test costs’’ is 

intended to achieve the following goals 

essentially the same outcome for all 

inert ingredients as the outcome the 

procedures under FIFRA section 

3(c)(2)(B) and section 3(c)(1)(F) produce 

for active ingredients. That is: 

• The companies who are the basic 

producers of an active ingredient or 

pesticide inert ingredient would 

typically bear the costs of testing. Those 

who purchase a pesticide inert 

ingredient from a basic producer (who 

becomes/is an original data submitter) 

or another ‘‘approved inert supplier’’ 

would not typically have to participate 

in joint development of, or offer to pay 

compensation for the right to rely on, 

required EDSP data. See Unit IV.C.3.c. 

• The recipients of the FFDCA 

section 408(p) test orders have a 

mechanism to resolve disputes and 

enforce agreements to develop data 

jointly and to share test costs. See Unit 

IV.C.1.b. 

• Subsequent entrants into the 

marketplace are, for an appropriate 

period of time, subject to the same data 

requirements, with provisions that 

would allow them to share the test costs 

rather than submit duplicative data. See 

Unit IV.C.2. 

• The recipients of the FFDCA 

section 408(p) test orders may cite or 

submit existing data (i.e., other 

scientifically relevant information) in 

lieu of developing new data, and ask 

EPA to determine whether the 

information can be used to satisfy part 

or all of the Tier 1 Order and/or 

otherwise inform the Tier 1 

determination. See Unit IV.C.1.c. 

EPA believes its approach will 

achieve essentially the same outcome 

for all inert ingredients as the outcome 

the procedures under FIFRA section 

3(c)(2)(B) and section 3(c)(1)(F) produce 

for active ingredients. 

In summary, EPA generally intends to 

adopt a policy that encourages data 

developers to join forces and agree on 

how to share costs, and that also 

encourages companies entering the 

marketplace after the data are developed 

to pay reasonable compensation to those 

that developed the data. To the extent 

permitted by FFDCA, EPA’s intended 

policies and procedures for EDSP 

resembles the policies and procedures 

used for Data-Call-Ins under FIFRA. 

1. Minimizing duplicative testing. As 

a point of clarification, a substantial 

amount of overlap exists between the 

goal of minimizing duplicative testing 

and the topic discussed in the next unit, 

allowing parties to share the costs of 

conducting the tests. Consequently, 

some of the measures discussed in this 

unit to minimize duplicative testing will 

have certain implications for the 

decisions pertaining to cost sharing, and 

vice versa. 

In developing its policy and 

procedures, EPA draws on years of 

experience with pesticide registrants. 

This experience has shown that 

reducing the costs of complying with a 

test order is a powerful incentive in 

bringing companies together to jointly 

develop and submit data. However, 

there may also be disincentives to joint 

data development including the costs of 

organizing a consortium. EPA policy 

and procedures are primarily designed 

to minimize the disincentives. 

a. Recipients of 408(p) test orders. The 

Agency recognizes that, as the number 

of recipients of test orders increases, 

organizational costs also increase. EPA 

must balance the second goal mentioned 

in FFDCA section 408(p)(5)(B)— 

promoting ‘‘fair and equitable sharing of 

test costs’’—with the organizational 

costs of a large number of order 

recipients. As is discussed more fully in 

Unit IV.E., under FFDCA section 408(p), 

EPA may issue orders to pesticide 

registrants or manufacturers and 

importers. While EPA could issue 

orders to all the interested parties, 

including the registrants of end-use 

products containing the active or inert 

ingredient this would greatly expand 

the number of order recipients and 

complicate the organization of 

consortia. Under FIFRA, data generation 

is typically undertaken by the technical 

registrant, who is also a producer or 

importer of the chemical. EPA generally 


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intends to issue FFDCA 408(p) test 

orders to the basic producers of active 

or inert ingredients, balancing the goal 

of fairness with the need to keep the 

number of recipients low to avoid high 

organizational costs. 

Further, by issuing orders to 

manufacturers and importers of inert 

ingredients, EPA is able to avoid the 

confidentiality issues associated with 

inert ingredients. Most manufacturers 

claim their inert ingredients to be 

confidential; accordingly, EPA cannot 

reveal the inert ingredients in pesticide 

products and therefore generally could 

not reveal the companies to whom an 

order was issued. By issuing orders to 

manufacturers and importers, EPA can, 

with few exceptions, immediately 

inform a recipient of the identity of all 

other recipients, facilitating 

communication and the formation of a 

consortium. 

b. Resolving disputes and enforcing 

agreements. As described in the 

December 2007 Draft Policy and 

Procedures, the Agency has concluded 

that FFDCA section 408(p)(5) does not 

provide the authority to create 

requirements for joint data 

development, including a requirement 

to use binding arbitration to resolve 

disputes, as does FIFRA section 3. In 

EPA’s view, FFDCA section 408(p)(5)(B) 

merely establishes a qualified direction 

that the Agency ‘‘[t]o the extent 

practicable . . . minimize duplicative 

testing . . . .’’ This, standing alone, does 

not create new authority to compel 

companies to use arbitration to resolve 

disputes arising from an effort to 

develop data jointly, nor does it even 

authorize EPA to impose a requirement 

for joint data development. Rather, EPA 

believes that this provision directs the 

Agency to create procedures that 

operate within the confines of existing 

statutory authorities. 

While FFDCA section 408(p) does not 

allow EPA to impose requirements 

identical to those authorized by FIFRA 

section 3, EPA has the authority under 

FFDCA section 408(p) to develop 

Agency procedures that would facilitate 

joint data generation. Specifically, the 

Agency has discretion to determine 

what actions constitute compliance with 

a FFDCA section 408(p) test order, and 

EPA intends to apply this discretion in 

a manner that creates strong incentives 

for companies to voluntarily develop 

data jointly. At the same time, however, 

each recipient of an order under FFDCA 

section 408(p) has a separate obligation 

to satisfy the Tier 1 Order that they 

received. EPA thinks that FFDCA 

section 408(p) confers adequate 

discretion to consider that a recipient 

has fulfilled its obligation to provide 

data when: 

• The recipient individually or jointly 

submits results from the required 

studies, or 

• EPA judges that it would be 

equitable to allow the recipient to rely 

on, or cite, results of studies submitted 

by another person. 

The determination of whether it 

would be equitable to allow citation to 

another recipient’s data will be 

necessarily based on a case-by-case 

review of the specifics of the individual 

circumstances. However, the Agency 

believes that it would generally be 

equitable to allow a recipient of a 

FFDCA section 408(p) test order to rely 

on the results of studies submitted by 

another person where: 

• The data generator has given 

permission to the recipient to cite the 

results, or 

• Within a reasonable period after 

receiving the FFDCA section 408(p) test 

order, the recipient has made an offer to 

commence negotiations regarding the 

amount and terms of paying a 

reasonable share of the cost of testing, 

and has included an offer to resolve any 

dispute over the recipients’ shares of the 

test costs by submitting the dispute to 

a neutral third party with authority to 

bind the parties, (e.g., through binding 

arbitration). 

The Agency believes this approach to 

minimizing duplicative testing, which 

parallels that used under FIFRA section 

3(c)(2)(B), provides all recipients of 

FFDCA section 408(p) test orders 

adequate incentives to develop data 

jointly. In the first instance, where the 

data generator had granted permission 

for another party to cite its data, the 

equities are clear, and EPA has no 

reason for refusing to allow it. In the 

second instance, where the data 

generator received an offer to commence 

negotiations regarding the amount and 

terms of compensation and to go to a 

neutral decisionmaker with authority to 

bind the parties failing successful 

negotiations, EPA believes that the 

company has demonstrated a good faith 

effort to develop data jointly, and 

consequently would typically consider 

that the order recipient had complied 

with the order. Based on EPA’s 

experience under FIFRA, there would 

be little or no reason for a data generator 

to decline such an offer. Moreover, if 

EPA did not adopt such an approach, 

the end result would effectively confer 

the sort of ‘‘exclusive use’’ property 

rights established under FIFRA section 

3(c)(1)(F), on a broad category of data, 

and EPA does not believe that FFDCA 

section 408(p)(5) creates such rights, or 

provides EPA with the authority to 

create such rights. 

These conditions would also apply to 

recipients of ‘‘catch up’’ FFDCA 408(p) 

orders, who enter the market after the 

data have been submitted. 

c. Submission/citation of existing 

data. As under FIFRA, EPA provides the 

recipients of FFDCA section 408(p) test 

orders with the option of submitting or 

citing existing data, along with a 

rationale that explains how the cited or 

submitted study satisfies the Tier 1 

Order. Existing data may include data 

that has already been generated using 

the assay(s) specified in the Order, or 

‘‘other scientifically relevant 

information.’’ Other scientifically 

relevant information is information that 

informs the determination as to whether 

the substance may have an effect that is 

similar to an effect produced by a 

substance that interacts with the 

estrogen, androgen, and/or thyroid 

hormonal systems (e.g., information that 

identifies substances as having the 

potential to interact with the estrogen, 

androgen, and/or thyroid system(s); 

information demonstrating whether 

substances have an effect on the 

functioning of the endocrine system). 

Other scientifically relevant information 

may either be functionally equivalent to 

information obtained from the Tier 1 

assays—that is, data from assays that 

perform the same function as EDSP Tier 

1 assays—or may include data that 

provide information on a potential 

consequence or effect that could be due 

to effects on the estrogen, androgen or 

thyroid systems. Some ‘‘other 

scientifically relevant information’’ may 

be sufficient to satisfy part or all of the 

Tier 1 Order and/or otherwise inform 

the Tier 1 determination. The 

submission or citation of other 

scientifically relevant information in 

lieu of the data specified in the Order 

is discussed in Unit IV.F.1.b. 

The Agency has written a paper 

entitled EPA’s Approach for 

Considering Other Scientifically 

Relevant Information (OSRI) under the 

Endocrine Disruptor Screening Program. 

(Ref. 4). This paper was developed by 

EPA to provide guidance to EPA staff 

and managers who will be reviewing the 

responses to Tier 1 Orders issued under 

the EDSP, and may also be of interest to 

parties considering whether to submit 

other scientifically relevant information 

to EPA. This paper provides general 

guidance and is not binding on either 

EPA or any outside parties. Anyone may 

provide other scientifically relevant 

information, and the Agency will assess 

the information for appropriateness on a 

case-by-case basis to determine whether 

the information can be used to satisfy 


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part or all of the Tier 1 Order and/or 

otherwise inform the Tier 1 

determination. EPA will respond to the 

submitter in writing and will make its 

determination publicly available. A 

copy of the approach paper has been 

placed in the docket for this policy 

(Docket ID number EPA–HQ–OPPT– 

2007–1080). 

In summary, EPA believes this 

approach to minimizing duplicative 

testing, which parallels that used under 

FIFRA section 3(c)(2)(B), provides all 

recipients of FFDCA section 408(p) test 

orders adequate incentives to develop 

data jointly. 

2. Promoting cost sharing and data 

compensation. As noted in Unit IV.C.1., 

FFDCA section 408(p)(5)(B) directs the 

Agency to ‘‘develop, as appropriate, 

procedures for fair and equitable sharing 

of test costs.’’ Informed by its 

experience under FIFRA, EPA sees this 

provision as containing two related 

directives: 

• Promotion of the sharing of costs by 

companies that agree to develop data 

jointly (‘‘cost sharing’’). 

• Payment of compensation to a data 

generator by a person whose activity 

subsequent to the submission of the 

required data would make such 

payment equitable (‘‘data 

compensation’’). 

The first directive relates to sharing 

the cost of developing data between 

parties on the market when a test order 

is issued. The second directive relates to 

the payment by a person (who was not 

part of a joint data development 

agreement) to those that originally 

generated and submitted data, in 

exchange for relying on the results of 

their previously submitted study. These 

mirror the data generation and data 

compensation processes that have been 

followed for years under FIFRA, and the 

Agency believes those processes are a 

good starting point for dealing with 

these issues in the context of FFDCA 

section 408(p)(5) orders. Consistent with 

FFDCA section 408(p)(5)(B), EPA 

intends, ‘‘to the extent practicable,’’ to 

‘‘develop procedures for fair and 

equitable sharing of test costs’’ not only 

by persons in business when the initial 

FFDCA section 408(p) test orders were 

issued, but also by persons who enter 

the marketplace after the data are 

submitted. 

As discussed in Unit IV.C.1., EPA has 

developed procedures to implement 

FFDCA section 408(p) screening that 

minimize duplicative testing; these 

measures also have the effect of 

substantially fostering cost sharing 

among those who receive the initial test 

order. By using an approach which 

parallels that used under FIFRA section 

3(c)(2)(B), any disincentives for the 

recipients of FFDCA section 408(p) test 

orders to develop data jointly are 

addressed. EPA’s experience with 

FIFRA section 3(c)(2)(B) indicates that 

when multiple registrants receive DCI 

notices to produce the same data on the 

same active ingredient, they form 

consortia that work together to develop 

the required data. If manufacturers and 

importers receive FFDCA section 408(p) 

test orders containing the provisions 

previously discussed, EPA expects that 

they would behave in the same manner. 

a. Compensable data under the EDSP. 

With respect to determining the extent 

to which compensation for previously 

submitted studies is warranted, the 

threshold issue is what EDSP data will 

be ‘‘compensable.’’ Given EPA’s 

conclusion that FFDCA section 

408(p)(5)(B) does not give EPA the 

inherent authority to create new rights 

to compensation, the threshold for what 

is ‘‘compensable’’ requires 

consideration of existing statutory 

authority for compensation. To the 

extent the data are otherwise covered by 

any provision of FFDCA or FIFRA that 

requires a person to offer compensation 

for the right to cite or rely on data 

submitted by another person in 

connection with a pesticide regulatory 

matter, EPA must continue to enforce 

those provisions. 

FFDCA section 408(i) provides that 

data submitted under FFDCA section 

408 ‘‘in support of a tolerance or an 

exemption from a tolerance shall be 

entitled to . . . exclusive use and data 

compensation to the same extent 

provided by section 3 of [FIFRA].’’ The 

Agency considers any data generated in 

response to requirements under FFDCA 

section 408(p) on a pesticide chemical 

for which there is an existing tolerance, 

tolerance exemption, or pending 

petition to establish a tolerance or an 

exemption to be data submitted in 

support of a tolerance or an exemption. 

In fact, FFDCA section 408(b)(2)(D)(viii) 

explicitly requires EPA to consider 

‘‘such information as the Administrator 

may require on whether the pesticide 

chemical may have an effect in humans 

that is similar to an effect produced by 

a naturally occurring estrogen or other 

endocrine effects,’’ as part of its 

determination that a substance meets 

the safety standard. (21 U.S.C. 

346a(b)(2)(D)(viii)). Thus, EDSP data on 

active and pesticide inert ingredients for 

which there is a tolerance or tolerance 

exemption are compensable as outlined 

under FIFRA section 3(c)(1)(F). 

Moreover, data establishing whether a 

pesticide chemical (either active or 

inert) has the potential to interact with 

the endocrine system would be relevant 

to a FIFRA registration decision. Under 

FIFRA, EPA has a continuing duty to 

ensure that a pesticide meets the 

registration standard; EPA must 

consider all available data relevant to 

this determination. (See 7 U.S.C. 136a 

(bb) and 3(c)(5)). In the terms of FIFRA 

section 3(c)(1)(F), such data ‘‘support or 

maintain in effect an existing 

registration.’’ Thus, data generated in 

response to a FFDCA section 408(p) test 

order are compensable as outlined in 

FIFRA section 3(c)(1)(F) if the data are 

submitted by a pesticide registrant 

because FIFRA specifically grants those 

rights to registrants. 

Given EPA’s position that FFDCA 

section 408(p)(5)(B) does not give EPA 

the authority to modify FIFRA data 

compensation rights, the fact that EDSP 

data are potentially compensable under 

FIFRA raises questions about the 

interplay between the two statutes. For 

example, unlike FIFRA section 

3(c)(2)(B), FFDCA section 408(p) does 

not give EPA the authority to enforce an 

offer to pay compensation by 

suspending the registration of a 

noncompliant company. Thus, unless 

and until such data are used in support 

of a pesticide regulatory action under 

FIFRA, if a recipient of a test order 

made an offer but then refused to pay 

compensation or to participate in 

binding arbitration following the data 

submitters acceptance of that offer, the 

data generator’s only recourse would be 

to seek any judicial remedies that may 

be available. Consequently, rather than 

leave recipients with any ambiguity, 

EPA intends to issue orders to 

registrants to conduct EDSP testing 

pursuant to both FIFRA section 

3(c)(2)(B) and FFDCA section 408(p). 

In summary, most EDSP data are 

compensable under FIFRA or FFDCA 

section 408(i). Data for active and 

pesticide inert ingredients that have a 

tolerance or tolerance exemption or are 

the subject of a pending petition are 

compensable regardless of what 

companies submit the data. EDSP data 

generated from testing other active and 

inert ingredients are also compensable 

as long as, in the case of a joint 

submission, at least one of the 

submitters is a pesticide registrant or 

applicant. 

While much EDSP data are 

compensable under FIFRA or FFDCA 

section 408(i), some EDSP data will be 

generated by chemical manufacturers 

and importers of pesticide inert 

ingredients that have neither a tolerance 

nor tolerance exemption and are not the 

subject of a pending tolerance petition. 

(EPA refers to these substances as ‘‘nonfood use inerts.’’) Because such EDSP 

data could not be considered ‘‘data 


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submitted in support of a tolerance or 

exemption,’’ the data submitted on such 

substances in response to a FFDCA 

section 408(p) test order are not entitled 

to compensation under FFDCA section 

408(i). Moreover, since FIFRA section 

3(c)(1)(F) establishes compensation 

rights only for data submitted by an 

applicant or a registrant and inert 

ingredients do not have separate or 

technical registrations, data submitted 

to EPA in response to a FFDCA section 

408(p) order by a person who is neither 

a registrant nor an applicant are not 

compensable under FIFRA. However, 

although data on a non-food use 

pesticide inert are not compensable 

when submitted by a non-registrant 

pursuant to FFDCA section 408(p), such 

data would become compensable when 

submitted jointly by an applicant or 

registrant to support initial or continued 

registration of a pesticide product 

containing that inert ingredient. That is, 

if the submitters of data for a non-food 

use inert ingredient include a product 

registrant, EPA intends to consider the 

data compensable. 

In addition, EPA believes that the 

internal procedures it has adopted 

effectively provide manufacturers and 

importers with the same opportunity for 

cost sharing/compensation available to 

all other order recipients. 

Because EPA believes there are ways 

to make all EDSP data generated on 

pesticide inert ingredients compensable, 

EPA must consider what procedures to 

use to ensure persons who did not share 

in the cost of testing, but who benefit 

from the existence of such data, actually 

pay compensation. Under FIFRA section 

3(c)(1)(F), companies that apply for 

registrations of pesticide products after 

the data were submitted either would 

have to offer to pay compensation for 

the right to cite the data or would have 

to generate comparable data. 

Consequently, in the case of active 

ingredients, everyone who benefits from 

the existence of EDSP data on an active 

ingredient either shares the cost of the 

testing as part of the joint data 

development under FIFRA section 

3(c)(2)(B) or offers to pay compensation 

to the original data submitter under 

FIFRA section 3(c)(1)(F). 

The same is not true for pesticide 

inert ingredients. There is no 

mechanism under either FIFRA or 

FFDCA for directly requiring payment 

of compensation by companies that start 

to manufacture or import a pesticide 

inert ingredient after an original data 

submitter has provided EDSP data on 

the pesticide inert ingredient. Such 

companies are not subject to FIFRA data 

compensation obligations because they 

are not registrants or applicants for 

registration. Nonetheless, EPA believes 

that, by using its discretion under 

FFDCA section 408(p) to issue test 

orders to new manufacturers or 

importers of a substance for which 

EDSP data had previously been 

submitted, EPA can achieve 

substantially the same ends. 

FFDCA section 408(p)(5) provides 

that ‘‘[t]he Administrator shall issue an 

order to ‘‘. . .a person who manufactures 

or imports a substance for which testing 

is required under this subsection, to 

conduct testing in accordance with the 

screening program . . . .’’ Thus, under 

FFDCA section 408(p)(5), following the 

submission of required EDSP data on 

the ingredient by manufacturers or 

importers who were in the marketplace 

when the initial test orders were issued, 

EPA generally intends to issue a test 

order to a manufacturer or importer who 

begins to sell a pesticide inert ingredient 

after the test orders requiring the data 

were issued. The Agency refers to these 

as ‘‘catch-up’’ test orders. As with the 

initial FFDCA section 408(p) test order, 

recipients could fulfill the testing 

requirement either by submitting the 

results of a new study or by citing the 

data submitted by another person or by 

agreeing not to sell into the pesticide 

market. In furtherance of the goal of 

‘‘fair and equitable sharing of test 

costs,’’ the Agency would accept 

citation of existing data under the same 

circumstances that it would accept the 

citation for recipients of the original 

order—e.g., where the recipient of a 

catch-up test order either had the 

original data submitter’s permission or 

the recipient had made an appropriate 

offer to pay compensation to the original 

data submitter that also determined how 

disputes would be resolved. 

Unless new manufacturers or 

importers requested pesticide 

registrations, EPA cannot readily 

identify new entrants in the market. 

EPA is largely relying on the 

manufacturers and importers who are 

part of the data submitters’ task force to 

inform the Agency about new entrants 

to the market, at which time EPA 

intends to issue the FFDCA section 

408(p) ‘‘catch-up’’ test orders. Currently, 

EPA only intends to send ‘‘catch-up’’ 

FFDCA section 408(p) test orders to 

subsequent entrants into the 

marketplace within 15 years after the 

initial EDSP test order(s) for the 

chemical is issued—a time frame 

matching the period of compensability 

under FIFRA section 3(c)(1)(F). 

b. Who provides compensation under 

this approach? Although the procedures 

described would result in having all 

companies that manufacture or import a 

pesticide inert ingredient share 

equitably in the cost of generating 

required EDSP data, FIFRA imposes 

additional compensation requirements 

on the customers of such companies 

who purchase the pesticide inert 

ingredients for use in formulating their 

registered pesticides. Specifically, 

FIFRA section 3(c)(1)(F) requires an 

applicant for a new or amended 

registration to offer to pay compensation 

to the original submitter of EDSP data if 

the applicant’s product contains an 

ingredient (active or inert) for which 

EDSP data have been submitted. 

For all compensable data, the Agency 

interprets the formulator’s exemption to 

be applicable. The formulator’s 

exemption under FIFRA section 

3(c)(2)(D) would only be applicable to 

EDSP data generated on non-food use 

pesticide inerts if the data are submitted 

jointly by a registrant or applicant for 

registration. However, EPA believes that 

it can effectively achieve the same ends 

through the internal procedures it 

adopts, and through its discretion to 

selectively issue FFDCA section 408(p) 

test orders only to importers and 

manufacturers of such pesticide inert 

ingredients. The policy rationale 

underlying FIFRA’s formulator’s 

exemption is equally applicable in the 

case of non-food use pesticide inerts. 

Specifically, Congress believed that, so 

long as the requirements apply equally 

to manufacturers of a particular 

ingredient, the price of their product 

should also reflect any data 

development costs. Accordingly, 

requiring compensation of product 

purchasers would have the effect of 

requiring purchasers to pay data 

development costs twice—once as a 

condition of satisfying a FFDCA section 

408(p) test order, and thereafter as part 

of the price of the pesticide inert 

ingredients they purchase to make their 

products. (See 49 FR 30892, August 1, 

1984). As a result, EPA has adopted the 

following procedures to determine 

whether the end-use formulators have 

met their obligations to submit EDSP 

screening data. 

c. Determining whether compensation 

obligations have been met. Currently, 

EPA maintains a list of all data on active 

ingredients that would support a 

technical registration along with contact 

information for the owners of the data. 

This is the Data Submitters List. Product 

applicants must identify the chemicals 

in their product and, in the case of the 

active ingredient(s), they must identify 

the source of the ingredient(s). If the 

source of the active ingredient is a 

registered product that is labeled for the 

same (or more) uses as the applicant’s 

product, the applicant is entitled to 

claim the formulators’ exemption from 


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all data requirements relating to the 

purchased product and need not submit 

or cite such data. If the applicant is not 

eligible for the formulators’ exemption, 

an applicant must submit or cite 

required data (for a technical product 

registration, the required data are 

typically data submitted on the active 

ingredients to support a technical 

registration). The citation is 

accompanied by a certification that an 

offer to pay was made to the owners of 

the data. FIFRA requires that an 

applicant/registrant agree to binding 

arbitration to resolve disputes regarding 

compensation. If the applicant or 

registrant fails to fulfill either the terms 

of a compensation agreement or an 

arbitrator’s award, the owner of the data 

may petition the Agency to cancel the 

registration. These procedures are also 

applicable to EDSP data that are subject 

to FFDCA section 408(i). 

The approach outlined here to 

address compensation for EDSP data on 

pesticide inert ingredients is consistent 

with those adopted generically for all 

food use pesticide inert data, as there is 

no reason for creating separate 

procedures for EDSP pesticide inert data 

and all other food use pesticide inert 

data. 

First, for each pesticide inert 

ingredient on which EPA receives EDSP 

data, EPA intends to identify the data 

submitter on a ‘‘Pesticide Inert 

Ingredients Data Submitters & Suppliers 

List’’ (PIIDSSL). This list identifies 

every company that submits the 

required EDSP data (original data 

submitters). The PIIDSSL also contains 

the names of every company that 

fulfilled its obligation under a FFDCA 

section 408(p) test order by offering to 

share the cost of testing with other data 

developers, as well as any other 

company that the original data 

submitter identifies as entitled to serve 

as a source of the pesticide inert 

ingredient from whom an applicant or 

registrant may obtain the pesticide inert 

without making an offer to compensate 

the original data submitter (‘‘approved 

inert suppliers’’ or ‘‘approved sources’’). 

Second, under FIFRA section 

3(c)(1)(F), the action of submitting an 

application of a pesticide containing the 

pesticide inert ingredient will trigger the 

obligation for the applicant to provide 

compensable EDSP data. The applicant 

may satisfy this requirement by 

submitting new data or citing existing 

data. In most cases, however, EPA 

expects an applicant to comply by 

claiming that the pesticide inert 

ingredient comes from an ‘‘approved 

source’’ and therefore that the principles 

of the formulator’s exemption apply. To 

fulfill the obligation in this manner, 

EPA intends to require a pesticide 

applicant to identify the source of 

pesticide inert ingredients for which 

there are compensable EDSP data. Then, 

EPA would agree that the applicant had 

adequately complied with FIFRA 

section 3(c)(1)(F) and FFDCA section 

408(p)(3)’s requirements if the person 

identified as the source for the pesticide 

inert ingredient appears on the PIIDSSL 

as either an original data submitter or an 

approved source for that pesticide inert 

ingredient. 

Third, on a case-by-case basis, EPA 

may require current registrants to 

identify the source of a pesticide inert 

ingredient on which EDSP data have 

been submitted. If the registrant of a 

pesticide product identifies a source for 

the pesticide inert ingredient that is not 

on the PIIDSSL, the registrant would 

have the choice of changing its supplier 

of the pesticide inert ingredient to an 

approved source on the PIIDSSL list. 

(Note: EPA also intends to revise the 

guidance presented in PR Notice 98–10 

regarding notifications to provide that a 

registrant may not change the source of 

a pesticide inert ingredient on the 

PIIDSSL in its formulation by 

notification. Such a change must be 

made through an application for 

amended registration.) Should the 

registrant not choose to obtain the 

pesticide inert ingredient from an 

approved source, EPA generally intends 

to issue an order to the registrant, 

requiring the registrant either to 

generate the EDSP test data or offer to 

pay compensation to the original data 

submitter on the PIIDSSL. 

D. What Procedures Apply for Handling 

CBI? 

FFDCA section 408(p)(5)(B) also 

requires that EPA, to the extent 

practicable, develop, as necessary, 

procedures for the handling of CBI. 

Many of the same considerations laid 

out in Unit IV.C. are relevant to EPA’s 

implementation of this directive. EPA 

has therefore adopted a consistent 

approach with respect to the handling of 

CBI. 

As with the directives to develop 

procedures for sharing test costs and 

minimizing duplicative testing, EPA 

does not think that FFDCA section 

408(p)(5)(B) provides the authority for 

the Agency to either create new rights 

or to modify existing rights to 

confidentiality. Rather, EPA believes 

that this provision directs the Agency to 

create procedures that operate within 

the existing confines of FFDCA section 

408(i), FIFRA section 10, the Freedom of 

Information Act (FOIA), and the Trade 

Secrets Act. 

As explained in Unit IV.C., because 

EPA considers much of the data 

submitted in response to FFDCA section 

408(p) orders to be submitted in support 

of a tolerance or tolerance exemption, 

such submissions are entitled to 

confidential treatment to the same 

extent as under FIFRA section 10, 

pursuant to FFDCA section 408(i). In 

addition, CBI submitted by pesticide 

registrants in response to a FFDCA 

section 408(p) test order is considered 

as part of the registration process, and 

is therefore considered to be submitted 

in support of a registration. As such, 

that information is directly subject to 

FIFRA section 10. However covered, 

information subject to FIFRA section 10 

is provided certain protections that go 

beyond those authorized by FOIA. For 

example, FIFRA section 10(g) generally 

prohibits EPA from releasing 

information submitted by a registrant 

under FIFRA to a foreign or 

multinational pesticide producer, and 

requires the Agency to obtain an 

affirmation from all persons seeking 

access to such information that they will 

not disclose the information to a foreign 

or multinational producer. FFDCA 

section 408(i) extends the protection 

available under FIFRA section 10 for 

data submitted in support of a tolerance 

or tolerance exemption. 

All other CBI submitted in response to 

a FFDCA section 408(p) test order (i.e., 

data not in support of a registration or 

tolerance/tolerance exemption) is only 

protected by the provisions of the Trade 

Secrets Act which incorporates the 

confidentiality standard in FOIA 

Exemption 4. FOIA requires agencies to 

make information available to the public 

upon request, except for information 

that is ‘‘specifically made confidential 

by other statutes’’ or data that are ‘‘trade 

secrets and commercial or financial 

information obtained from a person and 

is privileged or confidential.’’ (5 U.S.C. 

552(b)(4)). Note that substantive criteria 

must be met to claim confidentiality of 

business information, as specified in 40 

CFR 2.208. 

As with EPA’s approach for data 

compensation, EPA considers that data 

submitted jointly with a registrant, or as 

part of a consortium in which pesticide 

registrants participate, to be data 

submitted in support of a tolerance/ 

tolerance exemption or registration, and 

therefore entitled to protection under 

FIFRA section 10. However, if a nonregistrant chooses not to partner with a 

registrant, such data is only subject to 

the protections available under FOIA 

and the Trade Secrets Act. 


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E. Who Would Receive FFDCA Section 

408(p) Test Orders Under the EDSP and 

How Would They Be Notified? 

Under FFDCA section 408(p)(5)(A), 

EPA ‘‘shall issue’’ EDSP test orders ‘‘to 

a registrant of a substance for which 

testing is required . . . or to a person 

who manufactures or imports a 

substance for which testing is required.’’ 

EPA has identified the following 

categories of potential test order 

recipients: 

• Technical registrants (basic 

manufacturers of pesticide active 

ingredients). Entities who manufacture 

or import an active ingredient and hold 

an active EPA registration (technical 

registrants in most cases). Usually a 

product with technical registration is 

used in the formulation of other 

pesticide products. However, EPA also 

uses this term in this policy statement 

to include registrants who use an 

integrated system, that is, those who 

produce their own active ingredient, as 

well as those who use an unregistered 

technical active ingredient. In the 

interest of simplifying this document, 

the phrase ‘‘technical registrant’’ will be 

used to refer to: 

(1) Registrants of a technical grade of 

active ingredient; and 

(2) Registrants whose products are 

produced using an integrated system, as 

defined in 40 CFR 158.153(g), (which 

includes registrants who use an 

unregistered technical active ingredient 

to manufacture their pesticide product). 

• End-use registrants (formulators/ 

customers). Registrants whose products 

are formulated and sold for end use; 

such product generally contain both an 

active ingredient as well as pesticide 

inert ingredients. The registrant does 

not necessarily manufacture or import 

the active pesticide ingredient or inert. 

• Manufacturers/importers. Entities 

who manufacture or import a pesticide 

inert ingredient that do not necessarily 

have to hold an EPA registration for the 

sale of pesticide products. This also 

includes those manufacturers of 

pesticide products that are intended 

solely for export, so long as another 

company has a U.S. pesticide 

registration for the chemical, or an 

import tolerance exists for that 

chemical. 

1. Pesticide active ingredients. EPA 

generally intends to send test orders 

issued pursuant to FFDCA section 

408(p) and FIFRA section 3(c)(2)(B) to 

technical registrants of the pesticide 

active ingredient. The Agency can easily 

identify the technical registrants of 

pesticide active ingredients. As 

previously noted, a technical registrant 

holds a registration for a specific active 

ingredient that it then formulates into 

end-use (or retail) products or that its 

customers purchase for formulation into 

end-use products. Typically much of the 

safety data EPA requires is conducted 

on the technical grade active ingredient, 

rather than on the end-use product. (See 

generally, 40 CFR part 158). 

Consequently, the ‘‘technical 

registrants,’’ who are typically not 

considered to be a small business, have 

historically been responsible for 

generating most of the data that support 

pesticide registrations. Registrants of 

end-use products generally rely on the 

data generated by the technical 

registrants in accordance with the 

‘‘formulator’s exemption’’ in FIFRA 

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

Some active ingredients are 

‘‘commodity chemicals,’’ that is, they 

may be used both in non-pesticidal 

products, such as drugs or cleaning 

products, and as active ingredients in 

pesticide products. When a company 

produces such a commodity chemical 

and that company does not sell or 

distribute the chemical as a pesticide 

within the meaning of FIFRA section 

2(u) and 40 CFR 152.15, FIFRA does not 

require registration of the chemical until 

it is sold or distributed in a product that 

is intended for a pesticidal purpose. 

However, FFDCA section 408(p)(5) 

specifies that EPA is to send test orders 

to manufacturers and importers of ‘‘a 

substance for which testing is required 

under this subsection,’’ and does not 

limit testing requirements only to 

manufacturers/importers of a pesticide 

chemical. Once EPA issues a test order 

for a pesticide chemical, a person who 

manufactures that chemical, even if not 

for use as a pesticide, is clearly 

manufacturing a substance for which 

testing is required, and consequently, is 

potentially subject to EPA’s authority 

under the plain language of FFDCA 

section 408(p)(5). 

Since EPA’s goal is to follow as 

closely as feasible its existing practices 

for data generation under FIFRA, EPA 

generally intends to issue FFDCA 

section 408(p) test orders initially only 

to current pesticide registrants (and if 

there are any, only to technical 

registrants). Such orders would be 

issued under the authority of both 

FFDCA section 408(p) and FIFRA 

section 3(c)(2)(B). The Agency expects 

to issue ‘‘catch-up’’ test orders to any 

entity selling a commodity chemical 

into the pesticide market. This will 

occur when a commodity chemical 

company is discovered to be selling into 

the pesticide market for 15 years 

subsequent to the initial issuance of the 

testing orders. 

2. Pesticide inert ingredients. EPA 

generally intends to send test orders 

issued pursuant to FFDCA section 

408(p) to current manufacturers and 

importers; and ‘‘catch-up’’ FFDCA 

section 408(p) test orders to 

manufacturers and importers who 

subsequently enter the marketplace for 

15 years after the initial test order(s) for 

the chemical is issued. For pesticide 

inert ingredients, manufacturers/ 

importers include any company that 

manufactures or imports the chemical 

regardless of whether it is a registrant 

and regardless of whether it directly 

sells the chemical for use as a pesticide 

inert. 

For the purposes of discussion, EPA 

identified two subclasses of pesticide 

inerts: 

• Food use pesticide inerts, i.e., 

pesticide inert ingredients with an 

existing or pending tolerance or 

tolerance exemption. 

• Non-food use pesticide inerts. 

a. Food-use pesticide inerts. If a 

pesticide inert ingredient has an 

existing or pending tolerance or 

tolerance exemption, data compensation 

and data confidentiality protection are 

available pursuant to FFDCA section 

408(i). For this class of pesticide inert 

ingredients, EPA generally intends to 

issue FFDCA section 408(p) test orders 

to manufacturers and importers. 

b. Non-food use pesticide inerts. EPA 

generally intends to send the FFDCA 

section 408(p) test orders only to 

manufacturers/importers of the 

substance used as a non-food use 

pesticide inert ingredient. Note that 

EDSP data submitted on non-food use 

pesticide inerts are not covered by the 

data compensation and data 

confidentiality provisions of FFDCA 

section 408(i) or by FIFRA, unless the 

data are submitted by a registrant or a 

consortium that includes at least one 

registrant. Therefore, although EPA does 

not currently intend to send initial test 

orders to registrants, EPA encourages 

non-registrant recipients who submit 

data to partner with a registrant, so they 

will receive added protections under 

FIFRA for proprietary information or 

compensation from applicants who use 

the pesticide inert ingredient to 

formulate their pesticide products. Bear 

in mind, however, that even where 

FIFRA’s compensation provisions do 

not apply, EPA expects that the 

Agency’s procedures (e.g., whereby 

companies entering the market after 

submission of the EDSP data would 

receive ‘‘catch-up’’ FFDCA section 

408(p) test orders) would lead to the 

manufacturers and importers subject to 

the initial FFDCA section 408(p) test 


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Federal Register / Vol. 74, No. 71 / Wednesday, April 15, 2009 / Notices 17571 

orders receiving offers to share test costs 

equitably. 

3. How would EPA identify order 

recipients? For FFDCA section 408(p) 

test orders involving pesticide active 

ingredients, the Agency intends to rely 

on the Office of Pesticide Programs’ 

(OPP’s) Office of Pesticide Programs 

Information Network (OPPIN). OPPIN is 

an internal OPP database for query, 

input and tracking of pesticide 

products, ingredients, studies, 

regulatory decisions and other 

information. The OPPIN system is 

typically used to produce study 

bibliographies or lists of registered 

products. EPA intends to use OPPIN to 

identify registrants of the pesticide 

active ingredients identified for initial 

screening under the EDSP. 

For FFDCA section 408(p) test orders 

involving pesticide inerts, the Agency 

intends to use OPPIN (where 

applicable), information from the TSCA 

Inventory Update Rule (IUR), and rely 

on other databases to identify 

appropriate manufacturers/importers 

and end-use registrants. These other 

databases may include publicly 

available sources like Dun and 

Bradstreet, online marketing material, 

etc. 

EPA intends to make public the list of 

recipients of FFDCA section 408(p) test 

orders and DCI notices and invite the 

public to identify additional persons 

who should have received the FFDCA 

section 408(p) test order. Commenters 

could either identify themselves or 

another person as additional candidates 

(with proper substantiation) for receipt 

of a FFDCA section 408(p) test order. If 

the identity of a company subject to the 

test order is claimed as CBI, EPA 

intends to offer the company an 

opportunity to identify an agent who 

would act on their behalf in all matters 

relating to the EDSP program. For any 

company that chooses to designate an 

agent, the Agency intends to make the 

name of the agent (instead of the 

company) public by including it on the 

list of recipients of FFDCA section 

408(p) test orders and DCI notices. If the 

identity of a company subject to the test 

order is claimed as CBI, and yet the 

company does not name an agent, that 

company’s ability to obtain data 

compensation from other parties (or rely 

on compensable data submitted by other 

parties) would likely be affected. EPA 

generally intends to publish the list of 

order recipients in the Federal Register 

and post it on the Agency’s website. 

EPA intends to update the list with 

subsequent publication(s) and posting(s) 

as appropriate. For example, the Agency 

intends to post the status of the testing 

orders, including the recipient’s 

response, on the Agency website so that 

both order recipients and the public can 

check on the status of responses to the 

orders. This public listing is intended to 

also facilitate the formation of consortia 

to develop data jointly since recipients 

would know all other entities required 

to generate the same data. 

4. How would EPA notify order 

recipients? Order recipients would be 

notified through their direct receipt of a 

FFDCA section 408(p) test order via 

first-class mail, with return receipt. 

Each order recipient would receive an 

‘‘EDSP Order Packet’’ that EPA expects 

will contain the signed order, a list of 

other order recipients for that chemical, 

and the Initial Response Form, prepopulated with the recipient-specific 

information and due dates for 

complying with the order. 

F. Potential Responses to a Test Order 

In general, EPA expects that the 

orders would direct recipients to utilize 

the following procedures to respond 

either to an initial FFDCA section 

408(p) test order or to a ‘‘catch-up’’ test 

order issued to a person who began to 

manufacture or import a pesticide inert 

ingredient for 15 years after the initial 

test order(s) for the chemical is issued. 

These options are also appropriate for 

responding to test orders issued jointly 

under the authority of FFDCA section 

408(p) and FIFRA section 3(c)(2)(B). 

1. Initial response. Each recipient 

would be directed to provide an initial 

response to EPA within 90 days of the 

issuance of the order. This initial 

response is intended to be used to report 

the recipient’s commitment to act in 

response to the test order in one of 

several ways for each assay specified in 

the order, and may indicate a different 

response commitment for each assay. 

To facilitate completion of this initial 

response within the 90 days, EPA has 

created two simple Initial Response 

Forms that EPA intends to pre-populate 

with basic information about the 

chemical and recipient to connect it to 

the specific order. One form is for use 

by the Individual Order recipient and 

the other is for use when a Consortium 

provides their group’s response. EPA 

intends to include both of the Initial 

Response Forms in the EDSP Order 

Packet that is sent to the recipients. 

Please note that in calculating the due 

date for the Initial Response Form, the 

Agency intends to include an additional 

10 calendar days to account for the 

Agency processing of the final order 

package for delivery to the Post Office. 

An Order recipient may elect any of 

these options for one or more of the 

assays in the Order, and is not limited 

to electing a single response for all 

assays, nor are they required to elect 

different options for each assay. For 

simplicity, however, the Response Form 

is structured so that recipients indicate 

their responses on an assay-by-assay 

basis—even if the response is the same 

for more than one of the assays. 

Any recipient who did not fulfill the 

commitments made in its initial 

response would be subject to 

enforcement action for its failure to 

comply with the FFDCA section 408(p) 

order, in accordance with section 

408(p)(5)(D). Having failed to perform 

the actions necessary for this response 

option, the recipient would be obliged 

to immediately comply with the order— 

i.e., to provide the data, within the time 

frame that had originally been required 

by the order. In addition, the recipient 

would potentially be subject to 

penalties, pursuant to 18 U.S.C. 1001, 

for willfully making any false or 

misleading statements to the Federal 

government. 

The recipient of a test order has 

several potential initial responses from 

which it can choose. The 90–day initial 

response options include the following. 

a. Recipient indicates that it intends 

to generate new data. Recipients would 

choose this option to indicate that it 

agrees to individually generate new data 

for the test(s) specified in the Tier 1 

Order. In the case of data pertaining to 

a pesticide inert ingredient for which 

there is no tolerance or exemption (a 

‘‘non-food use’’ inert ingredient), the 

recipient may negotiate an agreement to 

have a registrant of a product containing 

the pesticide inert ingredient submit the 

data after it is generated so that the data 

qualify for compensation under 

FIFRA—the data generator and the 

registrant could work out among 

themselves the details of such an 

agreement. 

b. Recipient indicates that it is 

submitting or citing existing data. The 

recipient would choose this option to 

indicate that it is submitting or citing 

existing data (including citing data 

previously submitted to the Agency) 

that they believe is relevant to one or 

more of the requests in the test order. 

The recipient’s initial response would 

include either the data or a reference to 

the data for each assay specified in the 

order. In submitting or citing existing 

data, the order recipient or other party 

should follow, as appropriate, relevant 

format guidelines described in Unit 

IV.F.4. and provide an explanation of 

the relevance of the data to the order, 

including, where appropriate, a cogent 

and complete rationale for why it 

believes the information is or is not 

sufficient to satisfy part or all of the Tier 

1 Order. 


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Data compensation procedures may 

apply to data previously submitted to 

the Agency. If the data cited or 

submitted are from a study that was not 

conducted exactly as specified in the 

protocols referenced in the test order or 

in accordance with accepted scientific 

methodology or protocol, including but 

not limited to those presented in EPA’s 

harmonized test guideline compendium 

(see http://www.epa.gov/oppts and 

select ‘‘Test Methods & Guidelines’’ on 

the left), the recipient would also 

identify the deviations from the 

applicable protocol(s), along with an 

explanation for the deviations, 

including an explanation as to why, 

notwithstanding the deviations, the 

protocol used for developing the cited 

or submitted data should still be 

considered as providing an accepted 

scientific methodology or protocol, and 

any other information relevant to a 

decision to accept the data as 

satisfaction of the Order. 

EPA would review any existing 

relevant information submitted or cited 

(including other scientifically relevant 

information) to determine whether the 

information is acceptable (i.e., the study 

was not rejected by the Agency for any 

reason related to completeness or 

quality) and satisfies the Order. 

Decisions about whether the 

information satisfies part or all of the 

Tier 1 Order will be based on the 

weight-of-evidence from all relevant 

information available. The Agency 

would notify the recipient in writing of 

its determination. 

If the Agency determines that the 

information cited or submitted as part of 

the initial response received from an 

Order recipient can be used to satisfy 

the Tier 1 Order, which will be based 

on the weight-of-evidence from all 

relevant information available to the 

Agency, the Initial Response Form is the 

only response required. 

If, however, EPA determines that the 

information cited or submitted as part of 

the initial response is insufficient to 

satisfy the Tier 1 Order, although it may 

satisfy part of the Order, the recipient 

would still need to satisfy the remainder 

of the Order. 

As indicated previously, EPA intends 

to use a weight-of-evidence basis, taking 

into account data from the Tier 1 assays 

and any other scientifically relevant 

information available, to determine 

whether the chemical has the potential 

to interact with the endocrine system. 

Chemicals that go through Tier 1 

screening and are found to have the 

potential to interact with the estrogen, 

androgen, or thyroid hormone systems 

will proceed to the next stage of the 

EDSP where EPA will determine which, 

if any, of the Tier 2 tests are necessary 

based on the available data. Tier 2 

testing is designed to identify any 

adverse endocrine-related effects caused 

by the substance, and establish a 

quantitative relationship between the 

dose and that endocrine effect. 

EPA is not currently able to provide 

definitive examples of the specific 

circumstances in which a chemical 

would be able to go directly to Tier 2 

testing; however, if an Order recipient 

chooses to make such a request, EPA 

will consider it, along with any 

justification provided. In general, it may 

in some cases be possible to determine 

that a particular chemical has the 

potential to interact with the endocrine 

system and therefore could proceed to 

Tier 2 even if Tier 1 data are limited. 

However, if only some of the Tier 1 data 

are available, there may not be sufficient 

information to determine that some of 

the Tier 2 data are not necessary. These 

determinations will be made in a 

weight-of-evidence judgment on a caseby-case basis and made publicly 

available for consideration by others 

with the same or similar circumstances. 

c. Recipient indicates that it intends 

to enter (or offer to enter) into an 

agreement to form a consortium to 

provide the data. The recipient would 

choose this option to indicate that it 

intends to enter (or has offered to enter) 

an agreement with other order 

recipients to form a consortium or task 

force to comply with the test order. Each 

consortium participant or potential 

participant is expected to submit an 

Initial Response Form within 90 days. 

The lead for the consortium is expected 

to submit documentation confirming the 

formation of the consortium or task 

force within 150 calendar days of 

issuance of the Order/DCI, or as part of 

their initial response. Such 

documentation would include the 

contact information for the primary 

consortia contact, a list of participants, 

and the intended consortia action/ 

response for each assay. EPA’s typical 

practice has been that, if the consortia 

fails to satisfy the order, all parties 

would be held to have violated the test 

order. 

Alternatively, recipients may provide 

EPA with documentation that they have 

made an offer to join the consortium or 

commence negotiations regarding the 

amount and terms of paying a 

reasonable share of the cost of testing, 

and have included an offer to submit to 

a neutral third party with authority to 

bind the parties to resolve any dispute 

over the recipient’s share of the test 

costs, (e.g., through binding arbitration). 

Note: EPA’s typical practice has been 

that, if the required data are not 

generated by the person(s) to whom the 

offer is made, all parties, including 

those that have made offers to pay or 

otherwise joined the consortium, would 

be held to have violated the test order. 

d. Recipient claims that they are not 

subject to the test order. The recipient 

would choose this option to indicate 

that they are not subject to the order 

because: 

(i) In the case of a test order that 

requires data on an active ingredient, 

the recipient is not a pesticide 

registrant, or 

(ii) In the case of an initial test order 

that requires data on a pesticide inert 

ingredient, the recipient does not 

currently manufacture or import the 

chemical. 

(iii) In the case of a ‘‘catch-up’’ order, 

the recipient obtains the chemical solely 

from persons who are either (1) the 

original data submitter; (2) a person who 

has complied with a test order by 

offering compensation; or (3) a person 

who is otherwise an approved source 

(i.e., is listed on the PIIDSSL) for that 

inert. An explanation of the basis for the 

claim, along with appropriate 

information to substantiate that claim, is 

required to allow EPA to evaluate the 

claim. 

The recipient’s initial response would 

include an explanation and 

documentation supporting their claim. 

If EPA verifies your claim of not being 

subject to the order, the Initial Response 

Form is the only response you are 

required to complete to satisfy the order. 

If, however, EPA cannot verify your 

claim, you must still comply with the 

order and the deadline(s) for responding 

remain. 

e. Recipient indicates that it intends 

to voluntarily cancel their 

registration(s). Registrants may request 

voluntary cancellation of their product’s 

pesticide registration(s) pursuant to 

FIFRA section 6(f). Such a request must 

be submitted within 90 days of the 

issuance of the order. Doing so would 

initiate the existing procedures for a 

voluntary cancellation (see 40 CFR 

152.99). Under those procedures, the 

registrant may either adopt the standard 

provisions for sale or use of existing 

stocks of their pesticide, or may propose 

an alternative procedure. If the recipient 

chooses this option, the Initial Response 

Form is the only response required to 

satisfy the Order as long as the 

Registrant completes the voluntary 

cancellation procedures. When their 

product’s pesticide registration(s) is 

canceled, the recipient would be 

considered to have satisfied the order. 

f. Recipient indicates that it intends to 

reformulate their product(s) to exclude 

the chemical from the formulation. In 


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place of submitting the data required in 

this order, a registrant may submit an 

application to amend the formulation of 

its product by removing as an ingredient 

of their product the chemical that is the 

subject of the order. For example, this 

may occur in the case of a pesticide 

inert ingredient if EPA issues orders to 

end-use registrants. Submitting such an 

application would initiate the existing 

procedures for reformulation, and such 

a request must be submitted within 90 

days of the issuance of the order. If the 

recipient chooses this option, the Initial 

Response Form is the only response 

required to satisfy the order as long as 

the registrant completes the 

reformulation procedures. When their 

product’s formulation has been 

changed, the recipient would be 

considered to have satisfied the order. 

g. Recipient claims a formulator’s 

exemption. A product registrant who 

receives an order to test a chemical and 

who purchases the chemical from 

another recipient that has agreed to 

generate the data may be eligible for a 

formulator’s exemption. The recipient’s 

initial response would include an 

explanation and documentation 

supporting their claim. EPA will 

confirm such claims of eligibility. A 

response asserting the formulator’s 

exemption would no longer be 

considered an appropriate response to a 

test order if the supplier of the chemical 

fails to comply with the test order (i.e., 

it fails to submit the data either 

individually or jointly with other 

recipients or it fails to comply with the 

terms of a compensation agreement or 

the binding decision of a neutral third 

party regarding the terms of 

compensation). If EPA confirms the 

eligibility claim, the Initial Response 

Form is the only response required to 

satisfy this order. If, however, EPA 

determines that the order recipient is 

not eligible, the recipient must comply 

with the order. 

h. Recipient indicates that it has or is 

in the process of discontinuing the 

manufacture or import of the chemical. 

The recipient of an order for a pesticide 

inert ingredient (i.e., manufacturer/ 

importer) would choose this option to 

indicate that they are in the process of 

discontinuing the manufacture or 

import of the chemical. The recipient’s 

initial response would include an 

explanation and documentation 

supporting their claim. EPA intends to 

verify such a claim. If EPA confirms the 

claim, the Initial Response Form is the 

only response required to satisfy this 

order. If, however, EPA determines that 

the claim is false, the recipient must 

comply with the order. 

i. Recipient indicates that it does not 

and will not sell the chemical for use in 

pesticide products. The recipient of an 

order for a pesticide inert ingredient 

(i.e., manufacturer/importer) would 

choose this option to indicate that they 

do not currently or agree to no longer 

sell their chemical for use in the 

pesticide market. To elect this option, 

the order recipient would indicate, as 

part of its initial response, that they 

commit to discontinue, on or before a 

date 6 months after the issuance of the 

test order, all sale and distribution of 

the pesticide inert ingredient that is the 

subject of the test order to any person 

who the recipient knows or reasonably 

should know, intends to use the 

substance in the formulation of a 

pesticide product. The order recipient 

would also indicate that it will include 

in all contracts for sale or distribution 

of the material a provision that 

contractually prohibits the purchaser 

from using the substance in the 

formulation of a pesticide product. As 

part of its initial response, the order 

recipient would be asked to provide a 

copy of the contract provision and a 

certification to include this contractual 

provision in any contracts entered into 

on or after a date 6 months after the 

issuance of the test order. 

j. Request an exemption under FFDCA 

section 408(p)(4). EPA recognizes that 

FFDCA section 408(p)(4) provides that 

‘‘the Administrator may, by order, 

exempt from the requirements of this 

section a biologic substance or other 

substance if the Administrator 

determines that the substance is 

anticipated not to produce any effect in 

humans similar to an effect produced by 

a naturally occurring estrogen.’’ In 1998, 

the Agency assessed the need to develop 

a specific list of substances to be 

exempted from EDSP testing or an 

exemption process for those substances 

that might not be anticipated to produce 

endocrine effects in humans (See Unit 

VI.L. of the December 1998 notice at 63 

FR 71542). In the 1998 FR notice, EPA 

also provided several examples of 

substances that might possibly be 

exempted. As the EDSP has evolved and 

more endocrine research has been 

conducted, it has become evident that, 

at this time, development of criteria to 

exempt certain substances or to 

otherwise identify any pre-determined 

or blanket exemptions from endocrine 

disruptor testing is premature. 

For the initial screening, EPA is not 

aware of sufficient data that would 

allow the Agency to confidently 

determine that a chemical meets the 

statutory standard for an exemption— 

i.e., that it is not anticipated to interact 

with the endocrine system. Although a 

relatively broad range of toxicity data 

are available for pesticide active 

ingredients regulated under FIFRA, in 

most cases EPA has not yet established 

how the available data might be 

confidently used to predict the 

endocrine disruption potentials of these 

chemicals. This may be due to the nonspecific nature of an effect or effects 

observed, questions related to whether 

the mode of action in producing a given 

effect or effects is or are endocrine 

system-mediated in whole or in part, or 

the lack of relevant data to make a 

judgment altogether. 

However, if an order recipient 

believes that this showing can be made 

for its chemical, the Agency would 

consider requests to issue such an 

exemption order on a case-by-case or 

chemical-by-chemical basis in response 

to individual submissions. In order for 

the Agency to make the necessary 

statutory finding to issue the exemption, 

the request would need to provide any 

hazard-related information that you 

believe would allow EPA to determine 

that your chemical is anticipated to not 

be an endocrine disruptor, i.e., is not 

anticipated ‘‘to produce any effect in 

humans similar to an effect produced by 

a naturally occurring estrogen.’’ 

k. Other initial responses—(i) Preenforcement challenges to a test order. 

A recipient may wish to challenge the 

test order. Unit IV.H., describes the 

informal process by which a recipient 

may raise, and EPA may review, 

objections to the issuance of a test order 

or to specific provisions in the order. In 

order for EPA to be able to respond to 

the objections in a timely manner, the 

recipient would need to state with 

particularity the scope and basis of the 

objection, providing sufficient detail to 

allow the Agency to evaluate the 

objection. For further information refer 

to Units IV.H. and IV.I. 

(ii) Additional EDSP screening is 

unnecessary because the chemical is an 

endocrine disruptor or was used as a 

‘‘positive control’’ in the EDSP 

validation effort. If an Order recipient 

chooses to ask EPA to reconsider some 

or all of the testing specified in the Tier 

1 Order, EPA would review the request, 

along with the appropriate information 

supporting the claim that additional 

EDSP screening of the chemical is 

unnecessary because the chemical is an 

endocrine disruptor or was used as a 

‘‘positive control’’ in the EDSP 

validation effort, on a case-by-case basis. 

Based on the information currently 

available, EPA generally expects that if 

the chemical was used by EPA as a 

‘‘positive control’’ to validate one or 

more of the screening assays, only the 

data submitted related to those assays 


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for which the chemical was used to 

complete the testing as part of the 

validation effort would be sufficient to 

satisfy the Tier 1 Order. 

As discussed in detail in Unit 

IV.F.1.b., under one of the response 

options provided in the Tier 1 Order, a 

recipient may choose to cite or submit 

existing data they believe can be used to 

satisfy part or all of the Tier 1 Order. 

Existing data may be of several types. 

An example may be an in vitro assay for 

transcriptional activation that is 

conducted with a different cell line and 

by a different protocol. But more 

generally, existing data may be other 

scientifically relevant information. 

Scientifically relevant information can 

include data from studies other than the 

EDSP Tier 1 assays, e.g., studies 

conducted to satisfy a 40 CFR part 158 

or part 161 data requirement, data from 

other studies conducted to address an 

identified issue, or data from studies 

found in the scientific literature. In 

addition to the Tier 1 Order recipient, 

anyone can submit other scientifically 

relevant information. To allow EPA to 

review the submission of other 

scientifically relevant information in a 

timely fashion, the submitter of the 

information should consider providing a 

scientifically sound rationale that 

explains how the submitted or cited 

data provides the information needed to 

satisfy part or all of the Tier 1 Order 

and/or otherwise inform the Agency’s 

Tier 1 determination. 

2. Generate the data specified in the 

Tier 1 Order. As indicated in the Initial 

Response Form, the recipient’s next step 

will vary depending upon their initial 

response. The process diagram in the 

docket outlines the overall process with 

the various response options. In general, 

assuming that the order recipient 

indicated that they will generate the 

data individually or as part of a 

consortium, the next step in responding 

to the order would be the generation of 

the data as specified. 

The tests would generally be 

conducted using the test protocols cited 

in the order because FFDCA requires 

that the test method be validated. If, 

however, an order recipient believes a 

deviation from the required protocol is 

needed, they would first consult with 

the Agency before deviating from the 

test protocol. All requests would be 

submitted with a clear rationale to allow 

the Agency to evaluate the request in a 

timely manner. EPA intends to review 

all protocol variations and send a 

written response to the specific order 

recipient in a timely fashion. 

In addition, order recipients 

generating data must adhere to the good 

laboratory practice (GLP) standards 

described in 40 CFR part 160 when 

conducting studies in response to a 

FFDCA section 408(p) test order. 

3. Submit a progress report. Unless 

EPA has notified the recipient that they 

have satisfied the order, EPA generally 

intends to ask each order recipient to 

submit a progress report to EPA 12 

months after issuance of the order. Each 

progress report would provide a brief 

description of the status of the 

recipients planned activities for each 

assay, and, if applicable, a description 

of any problems encountered or 

expected difficulties in meeting the 

schedule for complying with the order. 

4. Submit the data specified in the test 

order. Assuming that the order recipient 

indicated that they would generate the 

data individually or as part of a 

consortium, the next step in responding 

to the order would be the submission of 

the data as specified. The Agency 

generally intends for the order to 

include a final submission due date of 

24 months after the issuance of the 

order. In establishing this timeframe, the 

Agency considered: 

(a) The timeframes set for the initial 

response and consortia documentation; 

(b) The duration of each assay in 

terms of estimated timeframes for 

planning, performing the tests and 

documenting results; and 

(c) The estimated timeframes for 

preparing and completing the final data 

submission to EPA. 

EPA believes that having a single due 

date allows the order recipients to 

efficiently plan the activities necessary 

for generating and submitting the data, 

including entering into joint agreements 

and sequencing the laboratory activities 

as appropriate. Although EPA intends to 

establish a single due date, if the order 

recipient or consortia choose to submit 

the results from each assay individually, 

the order would be satisfied when the 

Agency determines the results 

submitted satisfy the order. 

The Agency intends to use the same 

submission procedures as those that are 

currently used for submitting other data 

in support of a pesticide registration, 

with only a few modifications. Once the 

data are generated, the recipient would 

prepare a submission package for 

transmittal to EPA. EPA intends for the 

orders to include requirements on how 

the data would be formatted or 

presented for submission to EPA. In 

general, EPA expects the orders to 

include the following instructions. 

a. Format for data submission. As part 

of a cooperative NAFTA project, EPA 

and the Canadian Pest Management 

Regulatory Agency (PMRA) developed 

standard data evaluation formats, or 

templates. The templates have been in 

use by these agencies since 2002 for 

writing their data evaluation records 

(DERs) of studies submitted under 

FIFRA and FFDCA to EPA and the 

Canadian data codes (DACOs). Although 

such templates do not currently reflect 

the assays being considered for the 

EDSP Tier 1 battery, the Agency intends 

to review and, as necessary, develop 

new or revised templates before the 

deadlines for submission of the data 

under the EDSP. 

The DER that the agencies prepare 

contains a study profile documenting 

basic study information such as 

materials, methods, results, applicant’s 

conclusions and the evaluator’s 

conclusions. The templates provide 

pesticide registrants and the public an 

opportunity to gain a better 

understanding of the regulatory science 

review and decision-making process. 

The agencies encourage registrants to 

include study profiles based on these 

templates in their study documents for 

all pesticide types. These templates 

describe the layout and scope of 

information that would be contained 

within a study profile and can serve as 

guides for preparation of study 

documents. Use of the templates 

improves the likelihood of a successful 

submission, since the information 

necessary for an efficient agency review 

is outlined. Additional details about 

these templates are available at: http:// 

www.epa.gov/pesticides/regulating/ 

studyprofile_templates/. 

In addition, Pesticide Registration 

(PR) Notice 86–5, entitled Standard 

Format for Data Submitted Under the 

Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) and Certain 

Provisions of the Federal Food, Drug, 

and Cosmetic Act (FFDCA), describes 

how to organize and format submittals 

of data supporting a pesticide 

registration (http://www.epa.gov/ 

PR_Notices/pr86-5.html). The Agency 

has begun the process of updating the 

guidance in PR Notice 86–5 to further 

clarify the data submission process for 

pesticide-related submissions and 

intends to provide the public with an 

opportunity to comment on the 

proposed revisions to PR Notice 86–5 

consistent with the procedures 

described in PR Notice 2003–3, entitled 

Procedural Guidance for EPA’s Office of 

Pesticide Programs Procedures 

Concerning the Development, 

Modification, and Implementation of 

Policy Guidance Documents; (http:// 

www.epa.gov/PR_Notices/pr2003-3.pdf). 

The Agency also intends to encourage 

FFDCA section 408(p) test order 

recipients to submit completed study 

profiles and supporting data in an 


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electronic format whether submitting 

one or several studies. OPP has 

established Adobe Portable Document 

Format (PDF) as the standard file format 

for the electronic submission of required 

studies, using compact disks as the 

transport medium. In addition, OPP 

recently announced an e-Submission 

initiative to help EPA move toward a 

more paperless environment. The 

information exchange from industry to 

EPA is based on a harmonized 

eXtensible Markup Language (XML) 

schema used by Canada’s PMRA, which 

has been adapted by EPA. This 

harmonization assures industry that a 

documentation package submitted to 

one participating regulatory agency can 

likewise be submitted to the other 

participating agency, thus increasing 

standardization and decreasing the 

burden on industry. EPA also believes 

that information submitted to EPA in 

the XML schema format is intended to 

improve data quality and allow for a 

more efficient pesticide registration 

process. To assist pesticide registrants 

with the creation of the e-Submission 

XML packages, EPA has established an 

e-Submission XML help desk. For more 

information about electronic 

submissions, go to http://www.epa.gov/ 

pesticides/regulating/registering/ 

submissions/index.htm. 

b. Transmittal document. In order for 

EPA to effectively track the compliance 

of each order recipient, each submission 

in satisfaction of a FFDCA section 

408(p) test order would need to be 

accompanied by a transmittal document 

that includes the following information: 

• Identity of the submitter. 

• The date on which the submission 

package was prepared for transmittal to 

EPA. 

• The FFDCA section 408(p) test 

order number. 

• Summary of the response 

commitment for each assay. 

• A list of the individual documents 

included in the submission, with 

relationship to assay specified. 

c. Individual study or test result 

documents. Unless otherwise specified 

by the Agency, and varying based on the 

order recipient’s initial response, EPA 

would generally expect each submission 

package to be in the form of individual 

documents or studies to address each 

assay specified in the order. As 

indicated previously, EPA does not 

anticipate the resubmission of 

previously submitted documents absent 

a specific Agency request. Instead it 

would be sufficient for previously 

submitted documents to be cited with 

adequate information to identify the 

previously submitted document. EPA 

would typically expect each study or 

document to include the following: 

i. A title page including the following 

information: 

• The FFDCA section 408(p) test 

order number. 

• The title of the study, including 

identification of the substance(s) tested 

and the test name or data requirement 

addressed. 

• The author(s) of the study. 

• The date the study was completed. 

• If the study was performed in a 

laboratory, the name and address of the 

laboratory, project numbers or other 

identifying codes. 

• If the study is a commentary on or 

supplement to another previously 

submitted study, full identification of 

the other study with which it would be 

associated in review. 

• If the study is a reprint of a 

published document, all relevant facts 

of publication, such as the journal title, 

volume, issue, inclusive page numbers, 

and date of publication. 

ii. Upon submission to EPA, any data 

confidentiality claims must be 

accompanied by a signed and dated 

document containing the appropriate 

statement(s) as described in the FFDCA 

section 408(p) test order, which EPA 

expects would reference PR Notice 86– 

5 or other available Agency guidance, as 

appropriate. 

iii. A statement of compliance or noncompliance with respect to GLP 

standards as described in 40 CFR part 

160, as applicable. 

iv. A complete and accurate English 

translation for any information that is 

not in English. 

5. Submit a written request for an 

extension. The FFDCA section 408(p) 

test order would identify a due date for 

submitting the data specified to EPA. If 

an order recipient determines that they 

will not be able to submit the data 

specified in the order to EPA by the due 

date, the recipient can submit a written 

request for a time extension that 

provides a clear rationale for the need 

for an extension, along with any 

supporting documentation, in order to 

allow the Agency to properly and timely 

assess the request. EPA intends to 

review all such requests and send a 

written response to the requester in a 

timely fashion. In most cases the 

original deadline would remain while 

EPA considers the request. The Agency 

intends to only grant extensions that 

were requested in writing. Ordinarily, 

extensions would only be available in 

cases of extraordinary testing problems 

beyond the expectation or control of the 

order recipient. Extensions would not 

be considered if the request for 

extension is not made in a timely 

fashion; or if it is submitted at or after 

the deadline. EPA intends to only grant 

extension requests in writing. 

6. Maintain records. EPA generally 

intends for the FFDCA section 408(p) 

test order to identify the following 

records that the recipient would 

maintain as part of compliance with the 

order. Typically, the Agency expects 

recipients to retain copies of the data 

and other information submitted to the 

Agency in response to an order. 

Under FIFRA section 8, all producers 

of pesticides, devices, or active 

ingredients used in producing 

pesticides subject to FIFRA, including 

pesticides produced pursuant to an 

experimental use permit and pesticides, 

devices, and pesticide active ingredients 

produced for export, are required to 

maintain certain records. As such, any 

recipients who are pesticide registrants 

or who otherwise submit their data in 

support of a pesticide registration will 

be held to the recordkeeping standards 

in 40 CFR part 169. Consistent with 40 

CFR 169.2(k), this includes all test 

reports submitted to the Agency in 

support of a registration or in support of 

a tolerance petition, all underlying raw 

data, and interpretations and 

evaluations thereof. Under part 169, the 

registrant must retain these records as 

long as the ingredient is contained in a 

pesticide product with a valid 

registration and the producer is in 

business, and such records must be 

made available to EPA or its agent for 

inspection upon request. 

Recipients who are not a registrant 

would also be asked to retain records 

related to the generation of the data and 

copies of other information submitted to 

the Agency in response to the order. In 

general, EPA would typically expect 

recipients who are not a registrant to 

also retain such records for the same 

length of time as a registrant, and to also 

make the records available to EPA or its 

agent for inspection upon request. 

G. What are the Consequences for a 

Recipient Who Fails to Respond or 

Comply with the Test Order? 

For pesticide active ingredients, 

FFDCA section 408(p)(5)(C)(i) requires 

EPA to issue to any registrant that fails 

to comply with a FFDCA section 408(p) 

test order ‘‘a notice of intent to suspend 

the sale or distribution of the substance 

by the registrant.’’ The proposed 

suspension ‘‘shall become final at the 

end of the 30–day period beginning on 

the date that the registrant receives the 

notice of intent to suspend, unless 

during that period a person adversely 

affected by the notice requests a hearing 

or the Administrator determines that the 

registrant has complied’’ with the 


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FFDCA section 408(p) test order. As 

specified by FFDCA section 

408(p)(5)(C)(iii), the Administrator shall 

terminate a suspension if the 

Administrator determines that the 

registrant has complied fully. 

For all pesticide inert ingredient 

manufacturers/importers, FFDCA 

section 408(p)(5)(D) provides for EPA to 

apply the penalties and sanctions 

provided under section 16 of TSCA (15 

U.S.C. 2615) ‘‘to any person (other than 

a registrant) who fails to comply with an 

[FFDCA section 408(p)] order.’’ 

H. Process for Contesting a Test Order/ 

Pre-enforcement Review 

FFDCA section 408(p) does not 

explicitly address the process for 

challenging a test order (e.g., if the test 

order recipient disagrees that a 

particular study is appropriate or valid). 

The statute only specifies the rights and 

procedures available to test order 

recipients who have failed to comply 

with a test order. Further, the issue is 

somewhat complicated by the fact that 

the statute establishes different 

procedures for enforcing the test orders 

against pesticide registrants and against 

chemical manufacturers or importers. 

(Compare 21 U.S.C. 346a(p)(3)(C) and 

(D)). Nor is this issue resolved by 

FFDCA section 408’s general judicial 

review provision; that provision is 

applicably solely to the enumerated 

actions, which do not include FFDCA 

section 408(p) test orders. (21 U.S.C. 

346a(h)). Consequently, FFDCA section 

408(p) is ambiguous on a number of 

issues, such as the availability of preenforcement review, and the issues that 

may be raised in an enforcement 

hearing. 

For pesticide registrants, FFDCA 

section 408(p)(5)(C) directs EPA to 

initiate proceedings to suspend the 

registration when a registrant fails to 

comply with a test order. (21 U.S.C. 

346a(p)(3)(C)(i)). Prior to the 

suspension, a registrant may request a 

hearing, but the statute restricts the 

issues in the hearing solely to whether 

the registrant has complied with the test 

order. (21 U.S.C. 346a(p)(3)(C)(ii)). The 

substance of the test order may not be 

challenged during this hearing. Thus, 

for example, to challenge whether EPA 

should have required a particular study, 

the registrant would need to challenge 

the test order itself in the appropriate 

district court. (See, e.g., Atochem v. 

EPA, 759 F.Supp. 861, 869-872 (D.D.C. 

1991)). The basis for the statutory 

restriction is that the FFDCA section 

408(p) test order constitutes final agency 

action, and as such, is subject to review 

upon issuance. (See, Atochem, supra). 

In addition, as discussed above, EPA 

currently intends to issue the test orders 

for testing of active ingredients jointly 

under FFDCA section 408(p) and FIFRA 

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

discussed above for challenging an 

FFDCA section 408(p) test order are 

wholly consistent with the procedures 

applicable to FIFRA section 3(c)(2)(B), 

which similarly limits the issues for 

resolution in any suspension hearing 

held for failure to comply with the 

order. (See 7 U.S.C. 136a(c)(2)(B)(iv)). 

Accordingly, EPA believes that for 

pesticide registrants, pre-enforcement 

review of the test order would be 

available directly in federal district 

courts under any approach, and based 

on the plain meaning of the statute, 

would be the only means to obtain 

judicial review of the validity of the test 

order itself. 

By contrast, FFDCA section 

408(p)(5)(D) provides that nonregistrants (manufacturers or importers 

of pesticide inert ingredients) are 

subject to monetary penalties through 

an enforcement proceeding, using the 

process established by TSCA section 16. 

Under TSCA section 16, civil penalties 

of up to $25,000 per day may be 

assessed, after an administrative hearing 

is held on the record in accordance with 

section 554 of the Administrative 

Procedures Act (APA). (15 U.S.C. 

2615(a)(1)–(2)(A)). Before issuing a final 

penalty order, EPA must provide notice 

of its intention to assess the penalty, 

including a draft of the final penalty 

order, and provide the recipient with 

the opportunity to request a hearing 

within 15 days of the date the notice has 

been received. (15 U.S.C. 2615(a)(2)(A)). 

(See also, 40 CFR 22.13–22.14). TSCA 

section 16 also specifies that the 

following issues shall be taken into 

account in determining the amount of a 

civil penalty: The nature, 

circumstances, extent and gravity of the 

violation(s); the violator’s ability to pay; 

the effect on the violator’s ability to 

continue to do business; any history of 

prior violations; the degree of 

culpability; and such other matters as 

justice may require. (15 U.S.C. 

2615(a)(2)(B)). 

Although neither FFDCA section 

408(p) nor TSCA section 16 expressly 

imposes the same restriction on the 

issues that a non-registrant may raise in 

the penalty hearing, EPA’s 

interpretation of the statutes and 

existing regulations is to impose a 

similar restriction. In large measure this 

interpretation turns on the fact that, at 

least for pesticide registrants, FFDCA 

section 408(p) test orders constitute 

final agency action, and consequently, 

would be subject to review in the 

appropriate district court. Logically, it 

makes sense to interpret the test order 

to be final for all parties, as the 

provisions of FFDCA section 

408(p)(5)(A) that describe the test order 

do not distinguish between registrants 

and other test order recipients. 

Accordingly, pre-enforcement judicial 

review of the test order will be 

available, and would be the means by 

which any test order recipient would 

challenge the validity of the test order. 

As a consequence of that interpretation, 

EPA interprets TSCA section 16 to 

restrict the issues that may be raised in 

any enforcement hearing to whether the 

test order recipient had violated the test 

order, as well as the appropriate amount 

of any penalty. This interpretation is 

consistent with the issues listed in 

TSCA section 16(a)(2)(B), which do not 

expressly relate to the validity of the 

underlying requirement. 

I. Informal Administrative Review 

Procedure 

EPA generally intends to include a 

provision in the FFDCA section 408(p) 

test order by which order recipients 

would raise any questions or challenges 

concerning the issuance of the test order 

to the Agency in response to the order. 

In addition, because the mere filing of 

the objection (or indeed, the filing of a 

judicial challenge) would not 

necessarily extend the deadline for 

submission of the studies, in order for 

this process to be completed in a timely 

fashion, EPA expects order recipients to 

present their objections with sufficient 

specificity and detail to allow the 

Agency to adequately and fairly 

evaluate the issue(s) presented. EPA 

intends to review the issues presented 

and provide a written response within 

a reasonable amount of time. The 

Agency understands that it will need to 

respond within sufficient time for the 

order recipient to either comply with 

the order or determine whether to 

pursue its concerns through judicial 

review. 

J. How Would EPA Handle Responses 

from Recipients of Test Orders? 

Just as there are many different, 

acceptable responses that recipients 

may provide to a test order, so too are 

there many actions that EPA may take. 

In some cases, a recipient’s response 

would affect only the recipient. This 

would be the case for a response from 

a test order recipient: 

• Who claims that it is not subject to 

the order (see Unit IV.F.1.d.); or 

• Who voluntarily cancels its 

registration (see Unit IV.F.1.e.); or 

• Who reformulates its registered 

products (see Unit IV.F.1.f.); or 


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• Who claims that it qualifies for the 

formulator’s exemption (see Unit 

IV.F.1.g.); or 

• Who claims that it does not or no 

longer manufacture(s) or import(s) the 

chemical (see Unit IV.F.1.h.). 

Each of these responses would only 

affect the specific recipient’s obligation 

under the order. If EPA agreed with the 

response, the recipient would not be 

required to generate the EDSP data (not 

subject to the order or qualified for the 

formulator’s exemption) or EPA would 

cancel the recipient’s registration as 

requested. EPA actions on these kinds of 

responses would not affect other order 

recipients; they would still be required 

to respond to the order by generating the 

data or making one of the other 

acceptable responses. 

In some cases, however, another 

recipient’s response may have 

consequences for other recipients. This 

would be the case for a response from 

a test order recipient: 

• Who intends to generate the data 

(see Unit IV.F.1.a.); or 

• Who cites or submits existing data 

(see Unit IV.F.1.b.); or 

• Who enter (or offer to enter) a joint 

agreement to generate the data (see Unit 

IV.F.1.c.); or 

• Who commits to not sell their 

chemical for use in the pesticide market 

(see Unit IV.F.1.i.). 

The following discussion summarizes 

how EPA expects to handle responses to 

test orders that may have consequences 

for other recipients. 

1. Publication order recipients, 

responses, and order status. As noted 

earlier, EPA intends to publish the list 

of all order recipients in the Federal 

Register and post the list on the 

Agency’s website. The Agency intends 

to also post the status of the testing 

orders, including recipients’ responses, 

on the Agency website so that both 

order recipients and the public can 

check on the status of responses to the 

orders. This information is intended to 

enable recipients of test orders to 

identify and join other order recipients 

to develop the data in response to the 

order, which in turn would help achieve 

EPA’s goals of minimizing duplicative 

testing and promoting fair and equitable 

sharing of test costs. For example, if 

more than one recipient has agreed to 

perform the required studies (see Unit 

IV.F.1.a.), it will be reflected on the list 

and having this information will help 

them explore the possibility of 

generating the data jointly. In addition, 

a recipient who has agreed to generate 

required EDSP data can see all other 

recipients who have informed the 

Agency that they would be willing to 

share the cost of performing the 

required studies (see Unit IV.F.1.b.). 

This information will aid in their 

sorting of offers to share the cost of 

generating the required data from any 

recipient whom EPA indicates has 

promised to make an offer to share test 

costs, but has not yet contacted the 

recipient. 

2. Publication of EPA decisions 

regarding reliance on existing data or 

requests for an exemption under section 

408(p)(4), and decisions challenging the 

issuance of the test orders. The EPA 

website would also contain information 

on decisions about whether a test 

recipient may rely on existing data (see 

Unit IV.F.1.c.). If so, the Agency intends 

to regard the existing data as meeting 

the requirement for all test order 

recipients. Similarly, if EPA determines 

that a recipient has demonstrated that 

the Agency should exempt the chemical 

from testing under section 408(p)(4) (see 

Unit IV.F.1.h.), that decision would 

apply equally to all test order recipients. 

Finally, a recipient’s challenge to the 

legal basis for a test order (see Unit 

IV.F.1.i.) might be resolved in a way that 

affects the validity of the order for other 

recipients. Publishing these decisions 

may also be considered by others with 

similar questions. 

3. Generation of data, tracking 

compensability of submitted data, and 

enforcing compensation obligations. 

When EDSP data on an active ingredient 

are submitted, EPA intends to handle 

the submission in the same manner 

used under FIFRA. The name of the data 

submitter would be added to the Data 

Submitters List and all future applicants 

for registration of a pesticide containing 

the active ingredient would be required 

to cite and offer to pay compensation in 

order to rely on the data for the 15–year 

period following submission of such 

data. 

In the case of EDSP data on pesticide 

inert ingredients, as explained in Unit 

IV.C.2.c., EPA intends to establish a list 

(i.e., the PIIDSSL) to identify any person 

who has submitted compensable data on 

a pesticide inert ingredient in response 

to a test order issued under FFDCA 

section 408(p). Assuming at least one 

recipient of a test order submits the 

required EDSP data, EPA would add the 

name of the submitter to the PIIDSSL 

under the name of the ingredient as an 

‘‘original data submitter.’’ The PIIDSSL 

would also include any other test order 

recipient who has made an offer to share 

the cost of testing as an ‘‘approved 

source,’’ i.e., a source from whom an 

applicant or registrant may obtain the 

pesticide inert and not have to offer to 

pay compensation to the original data 

submitter. Since it is important to have 

as complete a list of approved sources 

as possible, EPA encourages original 

data submitters to identify additional 

companies as approved sources, for 

example, because they have a contract 

to buy from the data submitter. Then, 

pursuant to FIFRA section 3(c)(1)(F), 

when an applicant’s product contains a 

pesticide inert ingredient on the 

PIIDSSL, the applicant would identify 

the source of the pesticide inert 

ingredient. If the applicant’s source does 

not appear on the PIIDSSL, the 

applicant would either switch to a 

source on the PIIDSSL, offer to pay 

compensation to the original data 

submitter(s) on the PIIDSSL, or generate 

their own data. 

EPA intends to also take a number of 

measures to ensure that pesticide 

registrants are not obtaining the 

pesticide inert ingredient from an 

‘‘unapproved’’ source. Shortly after the 

receipt of test order responses, EPA 

intends to make public the 

commitments made by recipients of test 

orders–the names of the companies that 

have agreed to generate (or share in the 

cost of generating) test data (‘‘data 

generators’’) and the names of the 

companies that have committed to 

discontinue selling into the pesticide 

market. If at least one order recipient 

has agreed to generate the required data, 

EPA intends to inform registrants that in 

the future they will need to obtain the 

pesticide inert ingredient only from a 

data submitter or approved source, offer 

to pay compensation to the data 

submitter for the right to rely on existing 

data, or generate new data. 

The Agency thinks these procedures 

will result in a system that effectively 

provides data use protections to 

generators of EDSP data on pesticide 

active and inert ingredients. Through 

this system all manufacturers and 

importers of pesticide inert ingredients 

will understand whether or not they are 

allowed to sell into the pesticide 

market. If a manufacturer or importer 

takes the necessary steps that allow it to 

sell into the pesticide market, such a 

company would be listed on the 

PIIDSSL. Those manufacturers and 

importers whose products reached the 

pesticide market through other 

suppliers could add the names of the 

suppliers to the PIIDSSL. Similarly, 

through this system, applicants for new 

products and registrants of existing 

products will understand from which 

sources they may purchase a pesticide 

inert ingredient without having to offer 

to pay compensation, or without 

running the risk of needing to generate 

their own data. 

The Agency recognizes that these 

safeguards do not automatically ensure 

compliance with the data use 


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protections. But the Agency expects that 

manufacturers and importers who 

commit not to sell their chemical into 

the pesticide market will adhere to this 

promise and will work with their 

customers to ensure they also observe 

this market constraint. 

EPA also intends to take steps to try 

to prevent companies from 

inadvertently subverting the 

commitment made by order recipients. 

For example, the Agency’s Federal 

Register document that announces the 

issuance of the FFDCA section 408(p) 

order(s), would also inform those 

companies who sell a chemical that is 

used as a pesticide inert ingredient 

(other than test order recipients) that 

they may receive and become subject to 

an FFDCA section 408(p) order if they 

obtain the pesticide inert ingredient 

(either directly or indirectly) from a 

source who has not committed to 

generate the EDSP data but then sell the 

pesticide inert ingredient into the 

pesticide market. EPA intends to inform 

manufacturers who agree to generate the 

data that EPA intends to rely on them 

to bring to EPA’s attention information 

indicating that a pesticide registrant 

appears to be obtaining the pesticide 

inert ingredient from an ‘‘unapproved’’ 

source. As indicated previously, EPA 

intends to issue ‘‘catch-up’’ orders to 

any manufacturer or importer of a 

pesticide inert ingredient who enters the 

market place after EPA has issued a test 

order for that ingredient. 

4. All test order recipients for a 

pesticide inert ingredient ‘‘opt out’’ of 

the pesticide market. If no test order 

recipient has agreed to generate the 

required data, the Agency intends to 

issue a Federal Register notice 

informing registrants that the pesticide 

inert ingredient will no longer be 

available for use in formulating 

pesticide products unless someone 

commits to generate the required data. 

EPA intends to ask for a commitment to 

generate the required data within 6 

months of publication. After that date, 

EPA would take steps to remove the 

pesticide inert ingredient from its list of 

cleared pesticide inerts and to revoke 

any tolerances or tolerance exemptions 

for the pesticide inert ingredient. EPA 

would also remind registrants that 

under existing regulations, they must 

apply to amend their registrations before 

they may sell a pesticide product that 

has a composition that differs from the 

approved Confidential Statement of 

Formula for the product. On a case-bycase basis, EPA may issue a DCI notice 

and/or a section 408(p) test order for the 

required data to registrants whose 

products contain the pesticide inert 

ingredient. 

K. Adverse Effects Reporting 

Requirements 

Under FIFRA section 6(a)(2), pesticide 

product registrants are required to 

submit adverse effects information 

about their products to the EPA. Among 

other things, the implementing 

regulations in 40 CFR part 159, subpart 

D provide registrants with detailed 

instructions on whether, when, and how 

to report information in the possession 

of the registrant or its agents. 

In addition, under TSCA section 8(c), 

companies can be required to record, 

retain and in some cases report 

‘‘allegations of significant adverse 

reactions’’ to any substance/mixture that 

they produce, import, process, or 

distribute. EPA’s TSCA section 8(c) rule 

requires producers, importers, and 

certain processors of chemical 

substances and mixtures to keep records 

concerning significant adverse reaction 

allegations and report those records to 

EPA upon notice in the Federal Register 

or upon notice by letter. The TSCA 

section 8(c) rule also provides a 

mechanism to identify previously 

unknown chemical hazards in that it 

may reveal patterns of adverse effects 

which otherwise may not be otherwise 

noticed or detected. Further information 

is available under 40 CFR part 717. 

Under TSCA section 8(e), U.S. 

chemical manufacturers, importers, 

processors, and distributors are required 

to notify EPA within 30 calendar days 

of new, unpublished information on 

their chemicals that may lead to a 

conclusion of substantial risk to human 

health or to the environment. The term 

‘‘substantial risk’’ information refers to 

that information which offers reasonable 

support for a conclusion that the subject 

chemical or mixture poses a substantial 

risk of injury to health or the 

environment and need not, and 

typically does not, establish 

conclusively that a substantial risk 

exists. For additional information about 

TSCA section 8(e), please go to http:// 

www.epa.gov/oppt/chemtest/pubs/ 

sect8e.htm. 

EPA does not require duplicate 

submission of EDSP results under 

FIFRA section 6(a)(2) or TSCA section 

8(c) or (e). Any information submitted 

under FIFRA section 6(a)(2) or TSCA 

section 8(c) or 8(e) procedures does not 

need to be submitted again to satisfy the 

FFDCA section 408(p) test order. The 

test order recipient would instead 

submit the necessary information to cite 

to the previously submitted information 

as described earlier in this document. 

V. Statutory and Executive Order 

Reviews 

A. Regulatory Planning and Review 

Under Executive Order 12866, 

entitled Regulatory Planning and 

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

EPA submitted this document to the 

Office of Management and Budget 

(OMB) for review. Any changes made in 

response to OMB recommendations 

have been documented in the docket for 

this action as required by section 

6(a)(3)(E) of the Executive Order. 

B. Paperwork Reduction Act (PRA) 

The information collection 

requirements associated with issuing 

orders for Tier 1 screening under the 

EDSP have been submitted for review 

and approval by OMB under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq. 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. As 

a new ICR, the Agency does not yet have 

an OMB control number for this 

information collection activity. Once 

assigned, EPA will announce the OMB 

control number for this information 

collection in the Federal Register, and 

will add it to any related collection 

instruments or forms used, and include 

it in the orders issued. 

A copy of the final ICR package 

submitted to OMB for review and 

approval under the PRA (identified 

under EPA ICR No. 2249.01) has been 

placed in the docket for this policy. A 

draft of the ICR package was issued for 

public comment pursuant to the PRA 

and 5 CFR 1320.8(d) on December 13, 

2007 (72 FR 70839) (FRL–8155–8). The 

ICR has been revised to address 

comments received, and the following is 

a brief summary of the final ICR package 

that was submitted to OMB for approval 

under the PRA and which describes the 

information collection activities 

discussed in the final policy and 

procedures document, along with EPA’s 

estimated burden in more detail. 

Under the PRA, ‘‘burden’’ is defined 

at 5 CFR 1320.3(b). For the purposes of 

this ICR, the information collection 

activities include reviewing the order, 

providing the initial response, 

participating in a consortia, generating 

the data, preparing and submitting a 

progress report, submitting the data, 

requesting an extension, and 

maintaining records. As described in 

more detail in the ICR, the total 

estimated per chemical/per respondent 

paperwork burden is 3,008 hours, with 

an estimated cost of $212,369. 

Annualized over 3 years, the per 


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respondent burden is 1,003 hours, and 

the cost is $70,790. The total annualized 

estimated paperwork burden for this 

ICR is 108,364 hours, with an estimated 

total annual cost of $7,478,116 million. 

Although individual respondent burden 

varies based on their individual 

activities, this estimate assumes that the 

respondent actively participates in all 

potential activities, including 

developing consortia, generating all of 

the potential data, submitting a progress 

report, requesting an extension, and 

submitting the data. 

Pursuant to 5 CFR 1320.12, the 

submission of the ICR to OMB, along 

with a solicitation of comments on that 

ICR, is addressed in a separate 

document published elsewhere in 

today’s Federal Register. Please follow 

the instructions in that document to 

view the ICR and submit comments on 

the revised ICR. 

VI. References 

The following is a list of the 

documents that are specifically 

referenced in this document and placed 

in the docket that was established under 

Docket ID number EPA–HQ–OPPT– 

2007–1080. For information on 

accessing the docket, refer to the 

ADDRESSES unit at the beginning of this 

document. 

1. EPA. Endocrine Disruptor 

Screening and Testing Advisory 

Committee (EDSTAC) Final Report. 

August 1998. http://www.epa.gov/ 

scipoly/oscpendo/pubs/edspoverview/ 

finalrpt.htm. 

2. Organization for Economic 

Cooperation and Development (OECD). 

Final Report of the OECD Workshop on 

Harmonization of Validation and 

Acceptance Criteria for Alternative 

Toxicological Test Methods. August 

1996. 

3. EPA. Response to Comments on the 

Endocrine Disruptor Screening Program: 

Draft Policies and Procedures for Initial 

Screening and Testing. March 2009. 

4. EPA. EPA’s Approach for 

Considering Other Scientifically 

Relevant Information (OSRI) under the 

Endocrine Disruptor Screening Program. 

March 17, 2009. 

List of Subjects 

Environmental protection, Chemicals, 

Endocrine disruptors, Pesticides and 

pests, Reporting and recordkeeping. 

Dated: April 3, 2009. 

James Jones, 

Acting Assistant Administrator for 

Prevention, Pesticides and Toxic Substances. 

[FR Doc. E9–8706 Filed 4–14–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2004–0109; FRL–8399–7] 

Final List of Initial Pesticide Active 

Ingredients and Pesticide Inert 

Ingredients to be Screened Under the 

Federal Food, Drug, and Cosmetic Act 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: Section 408(p) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA) 

directs EPA to develop a chemical 

screening program using appropriate 

validated test systems and other 

scientifically relevant information to 

determine whether certain substances 

may have hormonal effects. In 

September 2005, EPA published its 

approach for selecting the initial list of 

chemicals for which testing will be 

required under the Endocrine Disruptor 

Screening Program (EDSP) and in June 

2007, EPA published the draft list of the 

first group of chemicals proposed for 

screening in the Agency’s EDSP. This 

document presents the final list of the 

first group of chemicals that will be 

screened in the Agency’s EDSP. The list 

was produced using the approach 

described in the September 2005 notice 

and considers comments received in 

response to the June 2007 draft list. The 

list includes chemicals that the Agency, 

in its discretion, has decided should be 

tested first, based upon exposure 

potential. The Agency deleted 6 

chemicals from the original list of 73 

based upon recent information showing 

that the chemicals are no longer 

expected to be found in 3 exposure 

pathways. The first group of 67 

chemicals identified for testing includes 

pesticide active ingredients and High 

Production Volume (HPV) chemicals 

used as pesticide inert ingredients (also 

known as other ingredients). This list 

should not be construed as a list of 

known or likely endocrine disruptors. 

Nothing in the approach for generating 

the initial list provides a basis to infer 

that by simply being on this list these 

chemicals are suspected to interfere 

with the endocrine systems of humans 

or other species, and it would be 

inappropriate to do so. This document 

does not describe other aspects of the 

EDSP such as the administrative 

procedures EPA will use to require 

testing, which is addressed in a separate 

notice published in today’s Federal 

Register. 

FOR FURTHER INFORMATION CONTACT: 

Linda Phillips, Office of Science 

Coordination and Policy (7203M), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(202) 564–1264; e-mail address: 

phillips.linda@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

This action is directed to the public 

in general. You may be potentially 

affected by this action if you produce, 

manufacture, use, consume, work with, 

or import pesticide chemicals. To 

determine whether you or your business 

may be affected by this action, you 

should carefully examine section 408(p) 

of FFDCA, 21 U.S.C. 346a(p). Potentially 

affected entities, using the North 

American Industrial Classification 

System (NAICS) codes to assist you and 

others in determining whether this 

action might apply to certain entities, 

may include, but are not limited to: 

• Chemical manufacturers, importers 

and processors (NAICS code 325), e.g., 

persons who manufacture, import or 

process chemical substances. 

• Pesticide, fertilizer, and other 

agricultural chemical manufacturers 

(NAICS code 3253), e.g., persons who 

manufacture, import or process 

pesticide, fertilizer and agricultural 

chemicals. 

• Scientific research and 

development services (NAICS code 

5417), e.g., persons who conduct testing 

of chemical substances for endocrine 

effects. 

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. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

B. How Can I Get Copies of this 

Document and Other Related 

Information? 

1. Docket. EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2004–0109. All documents in the 

docket are listed in the docket index 

available in regulations.gov. To access 

the electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. Although 

listed in the index, some information is 


rwilkins on PROD1PC63 with PROPOSALS