Endocrine Disruptor Screening Program; Policies and Procedures for Initial Screening, 17560-17579 [E9-8706]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17560-17579]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-8706]



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Part II





Environmental Protection Agency





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Endocrine Disruptor Screening Program; Policies and Procedures for 
Initial Screening; Final List of Initial Pesticide Active Ingredients 
and Pesticide Inert Ingredients To Be Screened Under the Federal Food, 
Drug, and Cosmetic Act; Notices

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

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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.

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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; e-
mail 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 https://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 https://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 https://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 https://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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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 https://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: https://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 Pre-screening or Quantitative Structure 
Activity Relationships models). More information on EPA's priority 
setting approach and the list of chemicals is available at https://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 non-pesticidal 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 pre-enforcement review and informal administrative review, 
and the procedures related to the citation or submission of other 
scientifically relevant information.

[[Page 17565]]

    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

[[Page 17566]]

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

[[Page 17567]]

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 ``non-food use inerts.'') 
Because such EDSP data could not be considered ``data

[[Page 17568]]

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 reci