[Federal Register Volume 74, Number 71 (Wednesday, April 15, 2009)]
[Notices]
[Pages 17560-17579]
From the Federal Register Online via the Government Publishing 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: <a href="/cdn-cgi/l/email-protection#b6c1d9d9d1d398c1dfdadadfd7dbf6d3c6d798d1d9c0"><span class="__cf_email__" data-cfemail="70071f1f17155e07191c1c19111d301500115e171f06">[email protected]</span></a>.

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:
    <bullet> Chemical manufacturers, importers and processors (NAICS 
code 325), e.g., persons who manufacture, import or process chemical 
substances.
    <bullet> Pesticide, fertilizer, and other agricultural chemical 
manufacturing (NAICS code 3253), e.g., persons who manufacture, import 
or process pesticide, fertilizer and agricultural chemicals.
    <bullet> 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:
    <bullet> Minimize duplicative testing (see Unit IV.C.).
    <bullet> Promote fair and equitable sharing of test costs (see Unit 
IV.C.).
    <bullet> Address issues surrounding data compensation (see Unit 
IV.C.) and confidentiality (see Unit IV.D.).
    <bullet> Determine to whom orders would generally be issued (see 
Unit IV.E.).
    <bullet> 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.).
    <bullet> 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.

[[Page 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 Pre-screening 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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    <bullet> The issuance of FFDCA 408(p) testing orders.
    <bullet> Responses and related activities for order recipients to 
use in responding to an order.
    <bullet> Joint data development, cost sharing, data compensation, 
and data protection.
    <bullet> 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

[[Page 17563]]

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.

[[Page 17564]]

    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:
    <bullet> Issuance of a notice to the person holding a pesticide 
registration under FIFRA section 3(c)(2)(B) (FFDCA section 
408(f)(1)(A)).
    <bullet> Issuance of a rule under section 4 of TSCA (FFDCA section 
408(f)(1)(B)).
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> The recipient individually or jointly submits results from 
the required studies, or
    <bullet> 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:
    <bullet> The data generator has given permission to the recipient 
to cite the results, or
    <bullet> 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:
    <bullet> Promotion of the sharing of costs by companies that agree 
to develop data jointly (``cost sharing'').
    <bullet> 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 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

[[Page 17569]]

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 
non-registrant chooses not to partner with a registrant, such data is 
only subject to the protections available under FOIA and the Trade 
Secrets Act.

[[Page 17570]]

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:
    <bullet> 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).
    <bullet> 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.
    <bullet> 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:
    <bullet> Food use pesticide inerts, i.e., pesticide inert 
ingredients with an existing or pending tolerance or tolerance 
exemption.
    <bullet> 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

[[Page 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, pre-populated 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.

[[Page 17572]]

    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 case-by-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

[[Page 17573]]

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 non-specific 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) Pre-enforcement 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

[[Page 17574]]

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

[[Page 17575]]

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:
    <bullet> Identity of the submitter.
    <bullet> The date on which the submission package was prepared for 
transmittal to EPA.
    <bullet> The FFDCA section 408(p) test order number.
    <bullet> Summary of the response commitment for each assay.
    <bullet> 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:
    <bullet> The FFDCA section 408(p) test order number.
    <bullet> The title of the study, including identification of the 
substance(s) tested and the test name or data requirement addressed.
    <bullet> The author(s) of the study.
    <bullet> The date the study was completed.
    <bullet> If the study was performed in a laboratory, the name and 
address of the laboratory, project numbers or other identifying codes.
    <bullet> 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.
    <bullet> 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 non-compliance 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

[[Page 17576]]

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 
pre-enforcement 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 non-
registrants (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:
    <bullet> Who claims that it is not subject to the order (see Unit 
IV.F.1.d.); or
    <bullet> Who voluntarily cancels its registration (see Unit 
IV.F.1.e.); or
    <bullet> Who reformulates its registered products (see Unit 
IV.F.1.f.); or

[[Page 17577]]

    <bullet> Who claims that it qualifies for the formulator's 
exemption (see Unit IV.F.1.g.); or
    <bullet> 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:
    <bullet> Who intends to generate the data (see Unit IV.F.1.a.); or
    <bullet> Who cites or submits existing data (see Unit IV.F.1.b.); 
or
    <bullet> Who enter (or offer to enter) a joint agreement to 
generate the data (see Unit IV.F.1.c.); or
    <bullet> 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

[[Page 17578]]

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-by-case 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

[[Page 17579]]

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


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