[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Notices]
[Page 70842-70862]
[DOCID:fr13de07-54]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2007-1080; FRL-8340-3]
RIN [2070-AD61]

Endocrine Disruptor Screening Program (EDSP); Draft Policies and
Procedures for Initial Screening; Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This document announces the availability of and solicits
public comment on EPA's draft policies and procedures for initial
screening under the Agency's 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. This document provides specific details on the policies and
the related procedures that EPA is considering adopting for initial
screening under the EDSP. In general, the Agency has tried to develop
policies that could be used in subsequent data collection efforts.
However, EPA expects that these policies may be modified as a result of
the Agency's experience applying them to the first chemicals to undergo
testing. This document also discusses 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 data
confidentiality. EPA will also be holding a public meeting to discuss
these policies and procedures. A separate Federal Register document
announced the details of the public meeting.

DATES: Comments must be received on or before February 11, 2008.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2007-1080, by one of the following methods:
     Federal e-Portal: http://www.regulations.gov. Follow the

on-line instructions for submitting comments.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-0001.

     Hand Delivery: OPPT Document Control Office (DCO), EPA
East Bldg., Rm. 6428, 1201 Constitution Ave., NW., Washington, DC.
Attention: Docket ID number EPA-HQ-OPPT-2007-1080. The DCO is open from
8 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the DCO is<PHONE_NUMBER>. Such deliveries are
only accepted during the DCO's normal hours of operation, and special
arrangements should be made for deliveries of boxed information.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPPT-
2007-1080. EPA's policy is that all comments received will be included
in the docket without change and may be made available online at http://www.regulations.gov
, including any personal information provided,

unless the comment includes information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Do not submit information that you consider to
be CBI or otherwise protected through regulations.gov or e-mail. The
regulations.gov website is an ``anonymous access'' system, which means
EPA will not know your identity or contact information unless you
provide it in the body of your comment. If you send an email comment
directly to EPA without going through regulations.gov, your e-mail
address will be automatically captured and included as part of the
comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket, visit the EPA Docket Center
homepage at http://www.epa.gov/epahome/dockets.htm.

    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Follow the instructions on the

regulations.gov website to view the docket index or access available
documents. Although listed in the index, some information is not
publicly available, e.g., 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<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. 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.

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:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>
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. To
determine whether you or your business may have an interest in this
notice you should carefully examine section 408(p) of the Federal Food,
Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 346a(p)). Potentially
affected entities and others may use the North American Industrial
Classification System (NAICS) codes to assist in determining whether
this action might apply an entity. Potentially affected entities may
include, but are not limited to:
     Chemical manufacturers, importers and processors (NAICS
code 325), e.g., persons who manufacture, import or process chemical
substances.
     Pesticide, fertilizer, and other agricultural chemical
manufacturing (NAICS code 3253), e.g., persons who manufacture, import
or process pesticide, fertilizer and agricultural chemicals.
     Scientific research and development services (NAICS code
5417), e.g., persons who conduct testing of chemical substances for
endocrine effects.
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. To determine whether you or your business may be affected by
this action, you should carefully examine the applicability provisions
in Unit IV.E. of this document, and examine section 408(p) of the
FFDCA. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

B. What Should I Consider as I Prepare My Comments for EPA?

    1. Submitting CBI. Do not submit CBI to EPA through regulations.gov
or e-mail. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD ROM that you mail
to EPA, mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    a. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    b. Follow directions. The Agency may ask you to respond to specific
questions or organize comments by referencing a Code of Federal
Regulations (CFR) part or section number.
    c. Explain why you agree or disagree and suggest alternatives and
substitute language for your requested changes.
    d. Describe any assumptions and provide any technical information
and/or data that you used.
    e. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    f. Provide specific examples to illustrate your concerns and
suggest alternatives.
    g. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.

    h. Make sure to submit your comments by the comment period deadline
identified.

C. Where Can I Access Information about the EDSP?

    In addition to accessing the public docket for this document
through http://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
.

II. Overview

A. What Action is the Agency Taking?

    The Agency is announcing the availability of and seeking public
comment on the draft policies and procedures that it is considering to
issue test orders pursuant to the authority provided by section
408(p)(5) of FFDCA. This document provides specific details on the
requirements associated with section 408(p) of FFDCA, format of FFDCA
section 408(p) test orders, and procedures. This document also
describes the actions and/or procedures that EPA is considering to:
     Minimize duplicative testing (see Unit IV.C.).
     Promote fair and equitable sharing of test costs (see Unit
IV.C.).
     Address issues surrounding data compensation (see Unit
IV.C.) and confidentiality (see Unit IV.D.).
     Determine to whom orders will be issued (see Unit IV.E.).
     Identify how order recipients should respond to FFDCA
section 408(p) test orders, including procedures for challenging the
orders (see Unit IV.F. and H.).
     Ensure compliance with FFDCA section 408(p) test orders
(see Unit IV.G.).
    EPA has also developed a template for the test order and an
information collection request (ICR) to obtain the necessary clearances
under the Paperwork Reduction Act (PRA). The templates for the test
orders and the draft ICR are available in the docket associated with
this Federal Register Notice. In addition, through a separate Federal
Register document, EPA is seeking public comment on the draft ICR and
draft templates.
    In addition, EPA will be holding a public meeting to discuss these
draft policies and procedures. In the Federal Register of November 23,
2007 (72 FR 65732) (FRL-8341-3), EPA announced the details of the
public meeting, which is posted on the EDSP website athttp://www.epa.gov/scipoly/oscpendo/meetings/mtg_121707.htm
.

    This document is intended to describe the administrative policies
and procedures that EPA is considering adopting as part of the
Endocrine Disruptor Screening Program (EDSP). 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. The policies and procedures presented in this
document may eventually be incorporated into an order issued pursuant
to section 408(p) of FFDCA.
    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 are under development for use under
the EDSP or the approach for selecting chemicals under the EDSP. In a
September 27, 2005, Federal Register Notice (70 FR 56449) (FRL-7716-9),
the Agency announced the approach that was used to identify chemicals
for initial screening under EDSP. The draft list of 73 chemicals to
undergo initial screening was published in a June 18, 2007 Federal
Register Notice (72 FR 33486) (FRL-8129-3). In a separate public
process, the Agency is coordinating the scientific validation and peer
review of the assays, which includes the development of protocols for
the assays. Additional information about all aspects of the EDSP,
including current status of these related parallel activities, is
available at http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/index.htm
.

B. 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 Federal Food, Drug, and Cosmetic Act (FFDCA) [21
U.S.C. 346aet. 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 effect, 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). Based on
these recommendations, EPA developed a two-tiered approach, referred to
as the EDSP. 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''), therefore, 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). 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 (SAP) Subcommittee further recommended
that initial screening be limited to 50 to 100 chemicals.
    EPA currently is implementing its EDSP in three major parts that
are being

developed in parallel, with substantial work on each well underway.
This document deals only with the third component of the EDSP (i.e.,
policies and procedures related to the issuance of orders). The other
aspects of the EDSP have been or will be addressed in separate
documents published in the Federal Register. 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. EPA is validating assays that are
candidates for inclusion in the Tier 1 screening battery and Tier 2
tests, and will select the appropriate screening assays for the Tier 1
battery based on the validation data. 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
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.
 In addition, on July 13, 2007, EPA published a Federal

Register document that outlined the approach EPA intends to take for
conducting the peer reviews of the Tier 1 screening assays and Tier 2
testing assays and EPA's approach for conducting the peer review of the
Tier 1 battery (72 FR 38577) (FRL-8138-4). EPA also announced the
availability of a ``list server'' (Listserv) that will allow interested
parties to sign up to receive e-mail notifications of EDSP peer review
updates, including information on the availability of peer review
materials to be posted on the EDSP website.
    2. Priority setting. EPA described its priority setting approach to
select pesticide chemicals for initial screening on September 27, 2005
(70 FR 567449), 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). The Agency expects to
publish a final list of chemicals that will be subject to initial
screening before EPA begins issuing orders to require testing in 2008.
More information on EPA's priority setting approach and the draft list
of chemicals is available at http://www.epa.gov/scipoly/oscpendo/pubs/prioritysetting.
 The first group of pesticide chemicals to undergo

screening is also referred to as ``initial screening'' in this
document.
    3. Procedures. The procedures are addressed by this document, which
describes EPA's policies relating to:
     Procedures that EPA would use to issue orders.
     How joint data development, cost sharing, data
compensation, and data protection would be addressed.
     Procedures that order recipients would use to respond to
an order.
     Other related procedures or policies.

C. 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 inert ingredients of
such pesticide.'' [FFDCA section 201(q)(1), 21 U.S.C. 231(q)(1)].
Active ingredients are the substances that suppress, control or kill
the target pests. Inert ingredients generally have no direct effect on
the target pests although they may have some degree of toxicity. 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. 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 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 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)].
    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 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 the Federal Insecticide, Fungicide,
and Rodenticide Act (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.
346a(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 an inert ingredient in
pesticides. If chemicals identified for future screening and testing
under the EDSP are not used in pesticides, the Agency will consider
whether the policies and procedures identified in this document and
used for pesticide chemicals would be appropriate for other categories
of substances.

D. How Will EDSP Data be Used?

    In general, EPA will use data collected under the EDSP, along with
other information, to determine if a pesticide chemical, or other
substance that may be found in sources of drinking water, may pose a
risk to human health or the environment due to disruption of the
endocrine system. Under the tiered approach, Tier 1 screening data will
be used to identify substances that have the potential to interact with
the endocrine system. Chemicals that go through Tier 1 screening and
are found to exhibit the potential to interact with the estrogen,
androgen, or thyroid hormone systems will proceed to Tier 2 for
testing. Tier 2 testing data will identify any adverse endocrine-
related effects caused by the substance, and establish a quantitative
relationship between the dose and that adverse effect. As the EDSP
screening and testing requirements mature into routine evaluations, the
Agency intends to utilize the pesticide registration review process as
the framework for managing its responsibilities regarding the endocrine
screening of pesticides, and intends to eventually incorporate these
requirements into the pesticide registration review process. At that
point, EPA will regard the endocrine disruptor screening and testing
required under FFDCA as part of the risk characterization of the
pesticide that is intrinsic to the FIFRA decision. While EPA has
discretionary authority to issue, at any time, testing orders requiring
manufacturers to conduct Tier 1 assays, the Agency plans to assess the
performance of the Tier 1 battery based on the test data received for
the initial list of chemicals before beginning to routinely issue
orders to test additional chemicals. If EDSP data exist at the time of
a pesticide's registration review, the

Agency will consider the data when it makes its FIFRA (3)(c)(5) finding
under registration review.

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 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 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 under section 16 of the Toxic Substances Control Act (TSCA)
[15 U.S.C. 2615] in the case of a violation referred to in that
section. [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
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 submitter has been granted permission to cite data or
that an offer of compensation has been made 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 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 ``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 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].

    FIFRA section 3(c)(2)(B) explicitly directs EPA to send notices of
data requirements (referred to as ``Data Call-In notices'' or ``DCI
notices'') to all registrants affected by the data requirement. It also
contains a

mechanism by which recipients of 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 data generator if the data
are relevant to the company's product and the company applies to
register its product after the required data have been submitted to
EPA. Lastly, the Agency may suspend the registration of a pesticide if
the registrant fails 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). The generic data exemption, in effect,
relieves an applicant of the obligation to cite and obtain permission
or offer to pay data compensation to cite the results of any 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 associated with its
product by charging buyers a higher purchase price. 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 generic data 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 provide for 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.
    3. Other sections of FFDCA. FFDCA section 408(f) establishes
procedures that the Agency ``shall use'' to require data to support the
continuation of a tolerance or exemption that is in effect. The
provision identifies three options:
     Issuance of a notice to the person holding a pesticide
registration under FIFRA section 3(c)(2)(B) [FFDCA section
408(f)(1)(A)].
     Issuance of a rule under section 4 of TSCA [FFDCA section
408(f)(1)(B)].
     Publication of a notice in the Federal Register requiring
submission, by certain dates, of a commitment to generate the data ``by
one or more interested persons.'' [FFDCA section 408(f)(1)(C)].
    Before using the third option, however, EPA must demonstrate why
the data ``could not be obtained'' using either of the first two
options. FFDCA section 408(f)(1) expressly provides that EPA may use
these procedures to ``require data or information pertaining to whether
the pesticide chemical may have an effect in humans that is similar to
an effect produced by a naturally occurring estrogen or other endocrine
effects.'' Finally, FFDCA section 408(f)(1)(B) provides that, in the
event of failure to comply with a rule under TSCA section 4 or an order
under FFDCA section 408(f)(1)(C), EPA may, after notice and opportunity
for public comment, modify or revoke any tolerance or exemption to
which the data are relevant.
    In addition, FFDCA section 408(i) provides that ``[d]ata that are
or have been submitted to the Administrator under this section or FFDCA
section 409 in support of a tolerance or an exemption from a tolerance
shall be entitled to confidential treatment for reasons of business
confidentiality and to exclusive use and data compensation to the same
extent provided by section 3 and section 10 of [FIFRA].''

IV. Policies and Procedures for the EDSP (Initial Screening)

    This Unit describes the policies and procedures that EPA is
considering to adopt for the initial screening required under the
program referred to above in Unit II.B. In general, the Agency has
tried to develop policies that could be used in subsequent data
collection efforts, including those under SDWA. However, the Agency
expects that these policies may be modified as a result of the Agency's
experience applying them to the first chemicals to undergo testing. A
diagram that graphically presents the overall process is available in
the docket.

A. Background

    On December 28, 1998 (63 FR 71542) (Ref. 1), EPA first discussed a
number of the more complicated policy issues relating to the
implementation of the screening program. These issues included:
     Under what authority EPA would require testing.
     How EPA would approach issues relating to minimizing
duplicative testing; sharing of test costs; and appropriate
compensation for the use or reliance on data submitted by a company
(i.e., data compensation).
     EPA's approach to protecting CBI and trade secrets, and
the public release of such information.
     Who would be required to conduct testing, including
whether exemptions would be available. (Ref. 1).
    In this document, EPA is describing the policies and procedures
that it intends to use for the initial EDSP screening of pesticide
chemicals. For some of these issues, EPA now has a preferred policy
approach; for other issues, EPA has laid out the various considerations
for public comment.
    EPA is soliciting comment on all of the draft policies announced in
this document. Prior to requiring screening and testing under the EDSP,
EPA will publish in the Federal Register the announcement of the final
policies and procedures it will adopt for initial screening. However,
EPA anticipates that it may modify the policies and procedures for
future EDSP screening efforts based on EPA's experience in applying
these policies and procedures during initial screening.

B. How Will EPA Require Testing of Pesticide Chemicals Under the EDSP?

    For the initial screening, EPA intends to issue ``test 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 is proposing to issue some orders jointly under the
authority of FFDCA section 408(p)(5) and FIFRA section 3(c)(2)(B).
    The Agency has drafted basic templates that would be used for such
test orders. These templates, which reflect EPA's preferred approaches,
differ according to whether the recipients are:
     Pesticide registrants, or
     Manufacturers and importers of inert ingredients.
    Finally, the test order templates may differ to accommodate
differences in the Agency's procedures for data compensation, and for
the minimization of duplicative data. Copies of the current draft test
order templates are included in the Docket and the Agency welcomes your
comments on the structure and clarity of these documents.
    There are some pesticide active and 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 Can EPA Do 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 also considered it
appropriate to promote cost sharing and data compensation. EPA also
originally contemplated that it would adopt new procedures unique to
the EDSP. After considering all of the issues, EPA is currently
considering adopting an approach that is similar to that announced in
the December 1998 Notice, but with some significant distinctions which
are discussed in more detail in this section.
    In summary, EPA's preferred approach to ``minimize duplicative
testing of the same substance'' and to promote the ``fair and equitable
sharing of test costs'' would be as follows:
     The companies, who are the basic producers of an active
ingredient or inert ingredient at the time EPA issues a data
requirements notice (FFDCA section 408(p) test order), would bear the
costs of testing and would be informed of all other order recipients.
     The recipients of the FFDCA section 408(p) test orders
would have strong incentives to work together to develop data jointly
and to share test costs.
     Subsequent entrants into the marketplace would receive
``catch-up'' FFDCA section 408(p) test orders making them subject to
the same data requirements with the same provisions to comply with the
requirement by making an appropriate offer to share the test costs that
includes a reasonable process for resolving disputes.
     Customers who purchase an inert ingredient from a basic
producer (who becomes/is an original data submitter) would not have to
participate in joint development of, or offer to pay compensation for
the right to rely on, required EDSP data.
    EPA believes its preferred approach would achieve for inert
ingredients essentially the same outcome as the procedures under FIFRA
section 3(c)(2)(B) and section 3(c)(1)(F) will produce for active
ingredients.
    In summary, EPA is considering adopting a policy that encourages
joint data developers to agree on how to share costs and also
encourages companies that enter the marketplace after the data are
developed to pay reasonable compensation to the data generators. EPA's
policy will resemble the provisions and procedures of FIFRA to the
extent allowed by FFDCA.
    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 section,
allowing parties to share the costs of conducting the testing.
Consequently, some of the measures discussed in this section that EPA
is considering adopting to try to minimize duplicative testing will
have certain implications for the decisions pertaining to cost sharing,
and vice versa.
    The Agency recognizes that, if EPA sends test orders under the EDSP
screening program to multiple companies that produce the same substance
and then each recipient of the test order conducts the required
studies, there could be a great deal of duplicative testing. Although
not discussed in the 1998 Notice, one way to avoid such duplicative
testing is to send the test orders only to a single person who would be
responsible for producing the required data. Unlike FIFRA section
3(c)(2)(B), FFDCA section 408(p) does not specifically require that
test orders be sent to all registrants of a particular pesticide. But,
when there are multiple people that produce the substance to be tested,
such an approach could potentially undercut the second goal mentioned
in FFDCA section 408(p)(5)(B)--promoting ``fair and equitable sharing
of test costs.'' Each company that manufactures a substance subject to
EDSP screening would benefit from the production of the data, and under
the most equitable approach, each should potentially pay a fair share
of the cost of testing. As a practical matter, however, people would
have little or no incentive to contribute to the cost of generating
EDSP data unless they each received a test order. Therefore, when there
are multiple producers of the substance, EPA believes that EDSP test
orders should generally be issued to each producer, and not just to a
single producer.
    The Agency originally anticipated relying on the authority of FFDCA
section 408(p) to establish new procedures to promote joint development
of data by recipients of FFDCA section 408(p) test orders (63 FR
71563). Now, however, the Agency no longer believes that FFDCA section
408(p)(5) provides the authority to create express requirements for
joint data development. 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 that
would minimize duplicative testing, EPA has the authority under FFDCA
section 408(p) to develop Agency procedures that achieve many of the
same ends. Specifically, the Agency has discretion to determine what
actions constitute compliance with a FFDCA section 408(p) test order,
and EPA can apply this discretion in a manner that creates strong
incentives for companies to voluntarily develop data jointly. While

there are good policy reasons not to require the same data from
multiple entities, under FFDCA section 408(p), each recipient of a data
requirements notice has a separate obligation to provide the required
data. EPA thinks that FFDCA section 408(p) confers adequate discretion
to consider that a recipient has fulfilled its obligation to provide
data when:
     The recipient actually submits results from the required
studies, or
     EPA judges that it would be equitable to allow the
recipient to rely on, or cite, results of studies submitted by another
person.
    The Agency believes that it would generally be equitable to allow a
recipient of a FFDCA section 408(p) test order to rely on the results
of studies submitted by another person where:
     The data generator has given permission to the recipient
to cite the results, or
     Within a reasonable period after receiving the FFDCA
section 408(p) test order, the recipient has made an offer to commence
negotiations regarding the amount and terms of paying a reasonable
share of the cost of testing, and has included an offer to 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 or through a state or federal court action).
    The Agency believes this approach to minimizing duplicative
testing, which parallels that used under FIFRA section 3(c)(2)(B),
would adequately address any disincentives for the recipients of FFDCA
section 408(p) test orders 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 would have 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 should 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.
    In addition to the specific procedures discussed in Unit IV.C.1.,
many of the procedures EPA is considering adopting to address cost
sharing and data compensation will effectively function to minimize
duplicative testing. Similarly, EPA has taken the directive to minimize
duplicative testing to the extent practicable into account in
determining who would receive FFDCA section 408(p) test orders. See
Units IV.C.2. and IV.D. for further discussion of these topics.
    In summary, EPA currently intends that it will typically treat a
suitably expressed offer to join in the development of a required study
as sufficient to comply with a test order under FFDCA section 408(p).
    2. Promoting cost sharing and data compensation. As noted in Unit
IV.C.1., FFDCA section 408(p)(5)(B) directs the Agency to ``develop, as
appropriate, procedures for fair and equitable sharing of test costs.''
Informed by its experience under FIFRA, EPA sees this provision as
containing two related directives:
     Promotion of the sharing of costs by companies that agree
to develop data jointly (``cost sharing'').
     Payment of compensation to a data generator by a person
whose activity subsequent to the submission of the required data would
make such payment equitable (``data compensation'').
    The first directive relates to sharing the cost of developing data
between parties on the market when a test order is issued. The second
directive relates to the payment by a person (who was not part of a
joint data development agreement) to those that originally generated
and submitted data, in exchange for relying on the results of their
previously submitted study. These mirror the data generation and data
compensation processes that have been followed for years under FIFRA,
and the Agency believes those processes are a good starting point for
dealing with these issues in the context of 408(p)(5) orders.
Consistent with section 408(p)(5)(B), EPA would, ``to the extent
practicable,'' like to ``develop procedures for fair and equitable
sharing of test costs'' not only by persons in business when the
initial 408(p) test orders were issued, but also by persons who enter
the marketplace after the data are submitted.
    FFDCA section 408(p)(5)(B) merely establishes a qualified direction
that the Agency develop ``as appropriate, procedures for fair and
equitable sharing of test costs.'' This, standing alone, does not
create new data compensation rights, nor does it authorize EPA to
create such rights. EPA has no inherent authority to create new rights
to compensation; such rights are created only by Congress, and must be
explicitly created by statute. FFDCA section 408(p)(5)(B) provides none
of the indicia that Congress intended to expand the current expectation
as to which data are compensable. For example, FFDCA section
408(p)(5)(B) is silent on a reimbursement period, processes and
acceptable arbitration organizations, EPA's role in the process,
penalties for non-compliance, and exemptions. Not only does EPA believe
that FFDCA section 408(p)(5) fails to provide EPA with the authority to
establish unique procedures for the EDSP, but EPA believes that this
provision does not authorize EPA to modify existing data compensation
rights established under FIFRA section 3 or FFDCA section 408(i).
    By contrast, FIFRA, TSCA, and FFDCA section 408(i) all provide
specific directions to the Agency on all of these issues. FIFRA section
3(c)(1)(F) establishes an elaborate set of criteria and procedures
governing the rights of data submitters to obtain either ``exclusive
use'' over or data compensation for data they submit to EPA. TSCA
section 4 has similarly detailed provisions. [See also 7 U.S.C. 136a
(c)(1)(F)(ii)-(iii); 15 U.S.C. 2603(c)(3)-(4)]. Similarly, section
408(i) of FFDCA, which extends FIFRA data compensation rights to data
submitted ``in support of a tolerance or tolerance exemption,''
effectively provides guidance on all of these issues, providing that
such data ``shall be entitled to. . .exclusive use and data
compensation to the same extent provided by [section 3 of FIFRA].''
    In summary, EPA interprets FFDCA section 408(p)(5)(B)'s direction
to require EPA to develop procedures that will promote cost sharing
among test order recipients and to provide for compensation for data
submitted pursuant to a FFDCA section 408(p) test order, but only to
the extent either FIFRA section 3 or FFDCA section 408(i) provide for
cost sharing or data compensation. As explained more fully in the
remainder of this unit, however, EPA believes that its approach to
minimizing duplicative testing will not only promote joint data
development, but also encourage cost sharing among all test order
recipients. In addition, EPA believes that most EDSP data developed in
response to FFDCA section 408(p) test orders will be

compensable under FIFRA, or pursuant to FFDCA section 408(i).
    As discussed in Unit IV.C.1., EPA intends to adopt procedures
implementing FFDCA section 408(p) screening that will minimize
duplicative testing; these measures will 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 would be
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. What data are compensable 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 belief 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. 136a(b)(2)(D)(viii)]. Thus, EDSP data on
active and inert ingredients for which there is a tolerance or
tolerance exemption will be 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 (2)(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 would be compensable as outlined in
FIFRA section 3(c)(1)(F) if the data are submitted by a pesticide
registrant.
    In summary, most EDSP data will be compensable under FIFRA or FFDCA
section 408(i). Data for active and inert ingredients that have a
tolerance or tolerance exemption or are the subject of a pending
petition will be compensable regardless of what companies submit the
data. Other active ingredients will also be 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 will be compensable under FIFRA or FFDCA
section 408(i), some EDSP data will be generated by chemical
manufacturers and importers of inert ingredients that have neither a
tolerance nor tolerance exemption and are not the subject of a pending
petition. (EPA refers to these substances as ``non-food use inerts.'')
Because such EDSP data could not be considered ``data submitted in
support of a tolerance or exemption,'' the data submitted on such
substances in response to a FFDCA section 408(p) test order would not
be 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, data submitted to EPA in
response to a FFDCA section 408(p) order by a person who is neither a
registrant nor an applicant would not become compensable under FIFRA.
However, although data on a non-food use 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 a registrant to
support continued registration of a pesticide product. In addition, EPA
believes that the internal procedures it intends to adopt would
effectively provide manufacturers and importers with the same
opportunity for cost sharing/compensation available to all other order
recipients.
    Given EPA's belief that FFDCA section 408(p)(5)(B) does not give
EPA the authority to modify FIFRA data compensation rights, the fact
that much EDSP data will also potentially be 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. 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 is considering issuing orders to registrants to
conduct EDSP testing pursuant to both FIFRA section 3(c)(2)(B) and
FFDCA section 408(p).
    Although EPA believes there are ways to make all EDSP data
generated on 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 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 an inert
ingredient after an original data submitter has provided EDSP data on
the 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 those manufacturers or importers
of a substance for which EDSP data had previously been submitted who
subsequently enter the market, 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), EPA may issue a test order to a
manufacturer or importer who begins to sell an inert ingredient
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. 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. In furtherance of the goal of ``fair and equitable sharing of
test costs,'' the Agency would accept citation of existing data only if
the recipient 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 could not readily identify new entrants in the
market. EPA would largely rely 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 could issue the FFDCA
section 408(p) catch-up orders.
    An issue arising under this approach is whether to send FFDCA
section 408(p) test orders to subsequent entrants into the marketplace
indefinitely or only to send them for a limited period of time. EPA is
proposing to only send ``catch-up'' FFDCA section 408(p) test orders to
subsequent entrants into the marketplace within 15 years--a time frame
matching the period of compensability under FIFRA section 3(c)(1)(F).
An additional issue that will need to be resolved is whether
manufacturers of inert ingredients who do not themselves market the
ingredients for use in pesticide products should be required to
generate data in response to a 408(p) test order. See Unit IV.F.1. for
further discussion of this topic. The Agency invites public comment on
these issues.
    b. Who will provide compensation? Although the procedures described
should result in having all companies that manufacture or import an
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 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 pesticide chemical ingredients except non-food use inerts,
the Agency interprets the formulator's exemption to be applicable.
Under FIFRA section 3(c)(2)(D), an applicant for registration of a
product may be excused from submitting or citing data pertaining to
registered products that the applicant has purchased from another
person. EPA has also taken the position that this principle extends to
a FIFRA applicant's purchase of food use inert ingredients, when all
applicable inert ingredient data requirements have been satisfied by
the inert ingredient manufacturer.
    The formulator's exemption under FIFRA section 3(c)(2)(D) is not
applicable to EDSP data generated on non-food use inerts (unless 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 inert ingredients. The
policy rationale underlying FIFRA's formulator's exemption is equally
applicable in the case of non-food use 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 inert ingredients they purchase to make their
products. [See 49 FR 30892, August 1, 1984]. As a result, EPA is
considering adopting the following procedures to determine whether the
end-use formulators had met their obligations to submit EDSP screening
data.
    c. How will EPA determine 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 on the owners of the data. This is the Data
Submitters List. Product registrants 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). Product registrants typically
cite the data submitted on the active ingredients to support a
technical registration. The citation is accompanied by either a claim
that the registrant is eligible for a formulator's exemption or proof
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
issues of reasonable compensation. If the applicant or registrant fails
to fulfill the agreement, the owner of the data may petition the Agency
to cancel the registration. These procedures would also be applicable
to EDSP data that are subject to FFDCA section 408(i).
    As previously noted, compensation for data on inert ingredients has
not been an issue to date so implementation of data compensation for
EDSP data on inert ingredients would involve new procedures. The
approach outlined here is also being considered for administering the
formulator's exemption for all food use inert data; EPA intends that
the procedures ultimately adopted for the EDSP will be consistent with
(if not the same as) those adopted generically for all food use inert
data, as there is no reason for creating separate procedures for EDSP
inert data and all other food use inert data.
    First, for each inert ingredient on which EPA receives EDSP data,
EPA would identify the data submitter on an ``Inerts Suppliers List.''
This list would contain the names of every company that had either
submitted the required EDSP data or fulfilled its obligation under a
FFDCA section 408(p) test order by offering to share the cost of
testing with other data developers. Second, EPA would need to require
pesticide applicants and registrants to identify the source of every
inert ingredient for which there are compensable EDSP data. Then, EPA
would consider that the end-use formulator had adequately complied with
FFDCA section 408(p)(3)'s requirement to conduct EDSP screening only if
the person identified as the source for the inert ingredient appeared
on the ``Inerts

Suppliers List'' for that inert ingredient. If the applicant or
registrant of the end-use product chose to use a source for the inert
ingredient that is not on the ``Inerts Suppliers List,'' EPA would
issue an order to the manufacturer of the inert ingredient, and/or to
the applicant or registrant, requiring the manufacturer and/or
applicant or registrant to generate the EDSP test data.
    The Agency could take the following possible approaches for
applying these procedures to determine whether the end-use formulators
had met their obligations to conduct EDSP screening:
    i. Determine compliance in conjunction with applications for new
and amended registrations. EPA could apply these procedures as part of
the routine processing of applications for new and amended
registrations. Under FIFRA section 3(c)(1)(F), the action of submitting
an application would trigger the obligation to identify the source of
an inert ingredient for which there were EDSP data. If the source cited
by the applicant was not on the ``Inerts Suppliers List,'' the
applicant would have the choice of either offering to pay compensation
to a source on the list or of changing sources to a supplier already on
the list. Should the applicant choose neither option, EPA would require
the applicant to generate EDSP data in order to obtain its
registration.
    ii. Determine compliance both in conjunction with applications for
registration, and during registration review. In addition to relying on
existing procedures under FIFRA section 3(c)(1)(F), EPA could also use
the registration review program authorized under FIFRA section 3(g).
Under registration review, EPA reexamines all previously registered
pesticide products approximately once every 15 years and, as necessary,
requires the registrants to take steps necessary to come into
compliance with the applicable statutory and regulatory requirements.
As part of such updating, EPA could require registrants to comply with
FIFRA section 3(c)(1)(F) with respect to the right to cite and rely on
EDSP data pertaining to an inert ingredient in their products.
Thereafter, the registrants would proceed as under the first option.
    iii. Issue test orders to end-use formulators. This option is
similar to the second, except that EPA would issue test orders under
either FFDCA section 408(p) or FIFRA section 3(c)(2)(B) to end-use
formulators whose products contain a particular inert ingredient,
rather than waiting until registration review. Under this approach, EPA
would continue to determine compliance in conjunction with applications
for registration, and would also issue test orders shortly after
submission of the EDSP data for a particular inert ingredient, to all
registrants whose products contain a particular inert ingredient. The
test orders would require the registrants either to provide the EDSP
data, to cite and offer to pay compensation for existing EDSP data, or
to demonstrate that the registrant purchased its product from a company
on the ``Inerts Suppliers List.'' Under this approach, EPA would also
determine compliance in conjunction with applications for new or
amended registrations.
    Among these three options, EPA prefers the first whereby data
compensation would be triggered as registrants sought new or amended
registrations. (As long as a registrant did not amend its registration,
it would not have to make an offer to pay compensation.) This is
because EPA believes that the registration and amended registration
processes should effectively capture all new and existing products. EPA
recognizes that although each of these procedures would make the
registration process more complex and require additional resources from
both the regulated community and EPA, the first seems to involve the
smallest increase in administrative burden. However, EPA requests
comment on the merits of the various approaches.
    The alternatives differ primarily by how quickly the original data
submitters could be assured that pesticide formulators are either
offering to pay compensation or are buying only from a supplier on the
``Inerts Suppliers List.'' Under the third option, this accounting
would occur shortly after submission of the EDSP data when all affected
registrants would receive test orders shortly after the submission of
the EDSP data and orders would require affected registrants to comply
within a short time period. The second option would require registrant
responses only as EPA reviewed products containing a particular active
ingredient. At the end of 15 years, however, all registrants would have
been required to comply with FIFRA section 3(c)(1)(F). While these
differences may seem significant, the Agency thinks that, in reality,
there is little difference between the options. If all manufacturers
and importers were parties to the initial submission, and so long as
EPA promptly issues ``catch up'' orders under FFDCA section 408(p) to
new manufacturers and importers of the inert ingredient as they enter
the marketplace, a product registrant should always discover that its
supplier is already on the list.
    As discussed, the requirements for instituting such procedures
could be onerous and would become more onerous over time as more inert
ingredients go through the EDSP. Registrants would eventually have to
identify the source of all inert ingredients, many of which can pass
through multiple packaging, wholesale, and retail steps before being
purchased by a formulator. Any time the registrant, or an actor in the
supply chain, changed sources, an amendment would be necessary along
with a new claim of exemption or offer to pay compensation. This would
discourage registrants from changing sources, even between suppliers on
the ``Inerts Suppliers List,'' potentially limiting competition and
leading to higher costs for producers and consumers of pesticide
products. EPA would have to process all changes, verify that exemptions
are valid, and maintain the ``Inerts Suppliers List,'' as well as
distinguish between compensable data and non-compensable data.

D. What Procedures Can EPA 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 III.C. are equally
relevant to EPA's implementation of this directive. EPA is therefore
adopting 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 also does not believe 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 will consider 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 data
would be 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 would be considered as part of the registration
process, and would therefore be considered to be data submitted in
support of a registration. As such that information would be directly
subject to

FIFRA section 10. However covered, data subject to FIFRA section 10
would be 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 would consider
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 would only be subject to the protections
available under FOIA and the Trade Secrets Act.

E. Who Would Receive FFDCA Section 408(p) Test Orders Under the EDSP
and How Will 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 generally identified the following
categories of potential test order recipients:
     Technical registrants (basic manufacturers of pesticide
active ingredients) - Entities who manufacture or import an active
ingredient and hold an active EPA registration (technical registrants
in most cases). Usually a product with technical registration is used
in the formulation of other pesticide products. However, EPA also uses
this term in this Notice to include registrants who use an integrated
system to 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; (2) registrants whose products are produced using an
integrated system, as defined in 40 CFR 158.1539(g); and (3)
registrants who use an unregistered technical active ingredient to
manufacture their pesticide product.
     End-use registrants (customers) - Registrants whose
products contain an active ingredient or an inert ingredient. The
registrant does not necessarily manufacture or import the active
pesticide ingredient or inert.
     Manufacturers/importer - Entities who manufacture or
import an inert ingredient that do not necessarily have to hold an EPA
registration for the sale of pesticide products. This would also
include 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. Technical registrants and manufacturers/importers vs. all
registrants and manufacturers/importers. 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.''
Registrants are entities that hold a license for the sale of pesticide
products. Pesticide products contain multiple substances, including
both active and inert ingredients. EPA thinks that this language gives
EPA the discretion to send FFDCA section 408(p) test orders to:
    a. Persons who manufacture or import an active ingredient or inert
ingredient.
    b. Registrants whose products contain an active ingredient or an
inert ingredient.
    c. People in both groups.
    Thus, the universe of recipients of FFDCA section 408(p) test
orders is potentially very large. In most cases, however, the Agency
expects that only one or a few companies would actually take the lead
in organizing and conducting required EDSP studies. For pesticide
active ingredients, the data developers are likely to be the companies
that manufacture the substances subject to test orders (or who import
the substances from a foreign manufacturer), as opposed to those who
purchase the ingredient from a manufacturer or importer and mix it to
make a pesticide product.
    For pesticide active ingredients, EPA believes sending FFDCA
section 408(p) test orders both to the technical registrant and to the
end-use registrant (their customers) would lead to unnecessary
administrative costs for EPA and the regulated industry. Similarly for
inert ingredients, EPA believes sending FFDCA section 408(p) test
orders to both the manufacturers/importers of the inert ingredient and
to the end-use registrants (whose pesticide product contains that inert
ingredient and the manufacturer's/importer's customer) would also be
unduly burdensome to the Agency and the regulated community. Issuing
FFDCA section 408(p) test orders to all registrants of pesticide
products containing the chemical would also serve to increase the
number of recipients, making the formation of data development groups
more challenging administratively. Further, issuing FFDCA section
408(p) test orders to all registrants of pesticide products containing
the chemical is unnecessary to promote fair and equitable sharing of
test costs. Product registrants, which are often small businesses,
would be quite unlikely to directly contribute to the actual conduct of
the required testing and may simply reformulate their products in
response to an order. Accordingly, EPA is considering an approach that
limits the issuance of FFDCA section 408(p) orders only to the
technical registrant of an active ingredient and to the manufacturer/
importer of the inert ingredients rather than to all registrants whose
products contain the ingredient.
    2. Pesticide active ingredients. The Agency can easily identify the
technical registrants of active ingredients. As previously noted, a
technical registrant holds a registration for a specific active
ingredient that the technical registrant formulates into end-use (or
retail) products they produce or that the technical registrant sells to
other companies 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 larger companies, have historically been responsible for
generating the data to support theend-use 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). In addition, there is a subset
of registrants that do not purchase a substance for use as an active
ingredient, but produce it themselves through an integrated process.
These registrants cannot rely on the formulator's exemption to satisfy
data requirements, but must generate data themselves or offer to pay
for relevant data that were previously generated by another registrant
(such as a technical registrant).
    As noted previously, some active ingredients do not have a separate
technical registration because a single company manufactures the
chemical and formulates it into pesticide products, but does not sell
the chemical separately to other formulators. The data to support a
technical registration exist, but are incorporated into the data for
the product registrations.
    Test orders under FFDCA section 408(p) may be sent either to
pesticide active ingredient technical registrants, or to both pesticide
active ingredient technical registrants and all end-use registrants
that utilize that pesticide active ingredient in their registered
product. EPA prefers the first approach.
    The primary disadvantage to issuing orders solely to technical
registrants arises in the (unlikely) event that the technical
registrant fails to submit the EDSP data. The penalty for failure to
comply with a FFDCA section 408(p) test order is suspension of the
technical registrant's registration. However, because EPA had not
issued a test order to the end-use registrant, EPA would have no basis
for suspending the end-use registrant's registration, and the end-use
registrant could legally continue to sell its products, even though,
just like the technical registrant, it had not submitted EDSP data.
Moreover, even if EPA immediately issued a test order to the end-use
registrant, the test order could not compel immediate compliance; the
registrant would need to be given adequate time to generate the data.
    Nonetheless, EPA believes that this disadvantage is ultimately
unlikely to be significant. First, if the technical registration has
been suspended, EPA expects that the end-use formulator would be
unlikely to find a source for its active ingredient, and consequently
would be unable to produce a product even though it could legally sell
one. Second, it has been EPA's experience that the technical
registrants rarely, if ever, fail to comply with DCIs, and thus, the
issue is unlikely to arise in practice.
    A second issue is that 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
without specifying its future use, FIFRA does not require registration
of the chemical until it appears 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 subject to EPA's authority under the
plain language of FFDCA section 408(p)(5).
    EPA requests comment on whether or not to send FFDCA section 408(p)
test orders to producers of commodity chemicals that do not hold a
pesticide registration for a product containing the substance to be
tested.
    3. Inert ingredients. For inert ingredients, test orders under
FFDCA section 408(p) may be sent to manufacturers/importers only, or to
both manufacturers/importers and one or more pesticide registrants who
use the inert ingredient in their pesticide product. For inert
ingredients, manufacturers/importers include any company that
manufactures or imports the inert chemical regardless of whether they
are a registrant and regardless of whether they directly sell the
chemical for use as a pesticide inert.
    For the purposes of discussion, EPA identified two subclasses of
inerts:
     Food use inerts, i.e., inert ingredients with an existing
or pending tolerance or an existing or pending tolerance exemption.
     Non-food use inerts.
    In addition, Unit IV.E.3.c. discusses the special considerations
that arise when an inert ingredient is contained within a mixture whose
composition is both proprietary and unknown by the registrant who
purchases it for use in a registered pesticide product; EPA refers to
this as an ``inert in a proprietary mixture.''
    a. Food-use inerts. If an inert 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 inert ingredients, EPA's preferred option is
to issue FFDCA section 408(p) test orders only to manufacturers and
importers. Limiting the universe of FFDCA section 408(p) test order
recipients should reduce the resources needed to issue the test order
(EPA) and to comply with the test order (regulated community) and
facilitate joint data submissions and cost sharing.
    Another approach would be to issue test orders to both
manufacturers and importers and to all registrants (both technical and
end-use) of products containing the inert(s). While this approach would
use the procedures familiar to registrants under FIFRA section
3(c)(2)(B), this advantage does not outweigh the added administrative
burdens associated with the process of identifying and notifying all
registrants using an inert ingredient in their pesticide formulations,
and the requirement for all of these registrants to respond to the
FFDCA section 408(p) test orders and DCI notices, without compromising
CBI. Moreover, many product registrants may simply reformulate their
products in response to such an order, which would require altering
their registrations. EPA would like to avoid such disruptions if there
are no data to indicate that the current formulation poses any risks.
    However, as discussed in Unit IV.C., issuing FFDCA section 408(p)
test orders to both end-use registrants and manufacturers and importers
of food use inerts would have implications for the timing of the
accounting with respect to registered end-use pesticide products. In
other words, issuing orders would assure that EPA determined shortly
after receiving the data that all end-use formulators either purchased
their ingredient from a company on the ``Inert Suppliers List''; made
an offer to pay; or received a test order to generate data. EPA's
preferred approach is to address compensation obligations as
registrants apply for or amend registrations. Unit IV.C., however,
discusses in more detail two other alternatives.
    b. Non-food use inerts. EDSP data submitted on non-food use 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. In recognition of this fact, EPA has identified two
possible options with regard to who receives the FFDCA section 408(p)
test orders and under what legal authority the orders are issued. The
options differ in administrative complexity and in the extent to which
the resulting data

receive protections under FIFRA section 3 and section 10.
    First, EPA could send the FFDCA section 408(p) test orders only to
manufacturers/importers of the substance used as a non-food use inert
ingredient. This option has the principal advantage of simplicity
(compared to the other options) and it limits the administrative
resources required for implementation by both the regulated community
and EPA. Under this option, however, data generators may not receive
added protections under FIFRA for proprietary information or
compensation from applicants and registrants that used the inert
ingredient to formulate their pesticide products. Even if FIFRA's
compensation provisions would not apply, the procedure whereby
companies entering the market after submission of the EDSP data would
receive ``catch-up'' FFDCA section 408(p) test orders would most likely
lead to the manufacturers and importers subject to the initial FFDCA
section 408(p) test orders receiving offers to share test costs
equitably.
    The second option would involve sending FFDCA section 408(p) test
orders to both manufacturers and importers and sending both FFDCA
section 408(p) test orders and DCI notices under FIFRA section
3(c)(2)(B) to registrants whose products contain the inert ingredient
(end-use registrant). This option has one principal disadvantage over
the first option--assuming at least one registrant participated in the
data development, this option would basically double the administrative
burden to EPA and the regulated community and have the same significant
disadvantages as discussed in connection with sending FFDCA section
408(p) test orders to all registrants of products containing a food use
inert. (See Unit IV.E.3.a.).
    After weighing the advantages and disadvantages of these options,
EPA believes that the first option represents the best balance. In
large measure, this is based on the Agency's judgment that the burden
to both the Agency and the recipients associated with issuing test
orders to all end-use registrants cannot be justified by the slight
advantages offered by issuing orders to end-use registrants. EPA
expects that manufacturers generally know who purchases their products,
and thus do not need EPA to identify them. Thus, manufacturers who wish
to partner with a registrant would still be able to do so, without the
need for EPA to also issue a test order to the end-use registrant.
    c. Inert ingredients in a proprietary mixture. The Agency faces
unique and particularly complex issues when dealing with a registrant
whose pesticide product contains an inert ingredient that is present
only because the registrant purchases a ``proprietary mixture.'' A
proprietary mixture is a product that contains one or more inert
ingredients and for which the exact composition is not known by the
purchaser. EPA requires the manufacturer of proprietary mixtures to
identify the ingredients in the product, and EPA considers this
information in deciding whether to approve the registration of the
product. But because the manufacturer of the proprietary mixture
considers its composition a trade secret, EPA is prohibited from
disclosing this confidential information to the registrant or others.
    For example, an end-use pesticide product may contain ``Super
Surfactant Ultra'' as an inert chemical component, but the formulator
of theend-use pesticide product does not know the exact contents of
``Super Surfactant Ultra.'' The Agency would face a difficult (if not
impossible) dilemma if EPA determined that it was necessary to obtain
EDSP data on one of the ingredients in ``Super Surfactant Ultra,'' and
EPA had chosen a procedure that involved sending FFDCA section 408(p)
test orders and/or DCI notices to all registrants whose product
contained that ingredient. In such a case, EPA may be prohibited from
disclosing information that could divulge the contents or nature of the
inert ingredients in ``Super Surfactant Ultra'' to the pesticide end-
use registrant. Since the very issuance of the test order could divulge
confidential proprietary information (the fact that ``Super Surfactant
Ultra'' contains a particular inert ingredient) to the recipient (the
registrant who purchases ``Super Surfactant Ultra'' but does not know
its composition), EPA may not be able to include the registrants who
purchase ``Super Surfactant Ultra'' among the recipients of the test
orders. If EPA does not send test orders to the registrants whose
products contain a proprietary mixture from the list of recipients,
these registrants would unfairly escape the obligation to respond to
the test order. On the other hand, if EPA does send test orders to
generate data on a specific inert ingredient to registrants whose
products contain a proprietary mixture, EPA would potentially violate
the prohibitions against disclosing CBI.
    If an inert ingredient appears in a pesticide product only as a
constituent of a proprietary mixture, there appears to be no
practicable way to minimize duplicative testing or to extend data
compensation and data confidentiality protections to data submitted for
the purposes of the EDSP unless the inert manufacturer is willing to
disclose the confidential composition of the mixture to at least one
pesticide registrant. EPA believes that a manufacturer might give EPA
permission to disclose to a registrant the fact that a proprietary
mixture contains a particular inert ingredient in order to ensure that
the registrant complied with the data compensation procedures to
identify the source of an inert ingredient. As previously discussed,
EPA cannot issue test orders or DCI notices to pesticide registrants
unless EPA can identify the substance to be tested. Consequently,
because of confidentiality issues (among other reasons), EPA's
preference would be to issue FFDCA 408(p) test orders involving inert
ingredients in confidential mixtures only to manufacturers/importers
and to registrants whose production, sale, or use of the inert
ingredient can be determined by publicly available information. Another
alternative would be to issue test orders to the manufacturer/importer
of the confidential mixture, rather than for its individual components.
This would not involve any disclosure of CBI, but it could lead to
duplicative testing in that an ingredient may already have been tested
separately. In addition, this option raises difficult scientific issues
involved in testing mixtures. EPA will continue to explore this issue,
and would welcome commenters' suggestions.
    4. Summary of who would receive orders under EPA's preferred
approaches. Specifically under EPA's preferred approach, EPA would take
the following actions to maximize joint data development, data
compensation, data confidentiality protections, and resource
efficiency:
     Pesticide active ingredients. Test orders issued pursuant
to FFDCA section 408(p) and FIFRA section 3(c)(2)(B) would be sent to
technical registrants of the pesticide active ingredient.
     Inert ingredients. Test orders issued pursuant to FFDCA
section 408(p) would be sent to current manufacturers and importers;
``catch-up'' FFDCA section 408(p) test orders would be sent to
manufacturers and importers who subsequently enter the marketplace
after the original orders had been issued.
    5. How will EPA identify order recipients? For FFDCA section 408(p)
test orders involving pesticide active ingredients, the Agency will
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.
    For FFDCA section 408(p) test orders involving inerts, the Agency
will use OPPIN (where applicable) 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. The Agency is
interested in public comment on the Agency's approach to identify FFDCA
section 408(p) test order recipients for inert ingredients.
    EPA generally plans to make public the list of recipients of FFDCA
section 408(p) test orders and DCI notices and to invite comments from
the public identifying additional persons who should have received the
data requirements notices. Commenters could either identify themselves
or another person as additional candidates (with proper substantiation)
for receipt of a FFDCA section 408(p) test order. Although not the
Agency's preferred approach, if EPA sends test orders to pesticide
registrants for EDSP data on inert ingredients, the Agency may not be
able to release a complete list of test order recipients that includes
the names of all affected registrants because this list could
effectively disclose proprietary information about the composition of
their formulations. (As discussed in Unit IV.C., EPA would have to give
affected registrants the option of identifying an agent to represent
them in matters relating to the test order, including being listed on
the list of recipients of the test order.) The list of recipients could
be published in the Federal Register, or posted on the Agency's
website. For example, the Agency is considering posting the status of
the orders on the website so that both recipients and the public can
check on the status of responses to the orders, and the list of
recipients could be part of that posting. The Agency seeks comment on
the mechanism for making the list of recipients public.
    6. How will order recipients be notified? Order recipients would be
notified through their direct receipt of a FFDCA section 408(p) test
order via registered mail. They would receive an order packet that will
contain the instructions, background materials, and forms needed to
comply with the order. (See the draft order template in the docket).

F. How Should Recipients Respond to a Test Order?

    The following procedures would be used by recipients who are
responding 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 an inert ingredient after EDSP data on a substance had been
submitted to EPA. These options would also be 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 a
response to EPA within 90 days of the issuance of the order. This
response is intended to allow the recipient to provide EPA with its
intended response. To simplify completion of this initial response
within the 90 days, EPA has created a simple Order Response Form. EPA
intends to include the form in the order packet, pre-populated with the
basic information to connect it to the specific order. A copy of the
draft form is available in the public docket for your review and EPA
encourages your comments and suggestions.
    The recipients of a test order would have several potential
response actions from which they could choose. The 90-day response
options include:
    a. Recipient indicates that they intend to generate new data. The
recipient would choose this option to indicate that they agree to
individually generate new data for each test specified to meet the
requirements of the order. In the case of data pertaining to an inert
ingredient for which there is no tolerance or exemption, the recipient
may negotiate an agreement to have a registrant of a product containing
the inert ingredient submit the data so that the data qualify for
compensation under FIFRA--the data generator and the registrant could
work out among themselves how actual compensation would be apportioned.
    b. Recipient indicates that they intend to enter (or offer to
enter) into an agreement to form a consortium to generate the data. The
recipient would choose this option to indicate that they are forming a
task force or consortium to comply with the test order. Recipients
would identify who is part of the consortium, as well as indicate for
which tests data will be generated. Alternatively, recipients may
provide EPA with documentation that they have made an offer to 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 or through a state or federal court action). Note:
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.
    c. Recipient indicates that they intend to rely on existing data.
The recipient would choose this option to indicate that they intend to
submit or cite existing data that satisfies the request in the test
order. The recipient's response would include either the data or a
reference to the data for each test that are being cited. Data
compensation procedures may apply. If the study is not exactly as
specified in the protocols attached to the test order, the recipient
should provide an explanation as to why the data should be accepted as
satisfaction of the test order. The Agency would expect that any such
hazard-related data would be scientifically comparable to data that
would be generated by the EDSP.
    For the initial screening, EPA expects that opportunities for order
recipients to respond in this manner will be limited. As mandated by
the statute, EPA has developed and validated appropriate assays and it
is unlikely that other studies would be acceptable under data quality
standards. During the validation process, however, a chemical on the
initial list might have been a test subject for a study listed in the
order. Order recipients may be able to cite these data if protocols,
which were modified over the course of validation, are sufficiently
similar. EPA intends to provide recipients with information about the
availability of validation studies along with the orders.
    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) They are not a pesticide registrant,
or (ii) they do not currently manufacture or import a chemical that
anyone uses as a pesticide active or inert ingredient. An explanation
of the basis for the claim, along with appropriate information to
substantiate that claim, would be required to allow EPA to evaluate the
claim.
    e. Recipient indicates that they intend to voluntarily cancel or
reformulate the product registration or discontinue the manufacture/
importation of the chemical. Registrants may request voluntary
cancellation of their product's pesticide registration pursuant to
FIFRA

section 6(f). Doing so would initiate the existing procedures for a
voluntary cancellation. Under those procedures, the registrant may
either adopt the standard procedures for sale or use of existing stocks
of their pesticide, or may propose an alternative procedure.
Alternatively, in the case of an inert ingredient, (if EPA issues
orders to end-use registrants) a registrant may submit an application
to amend the formulation of its product by removing the ingredient. In
the case of manufacturers/importers of both inert ingredients and
commodity chemical active ingredients, the recipient would choose this
option to indicate that they intend to agree to cease manufacture or
importation of the chemical.
    An additional option that EPA is considering would allow the
manufacturer/importer to continue production of the chemical, but would
involve their commitment to cease supplying the chemical for use in
pesticide products. EPA does not prefer this alternative because of the
practical difficulties in enforcing such agreements, given that there
may not be a direct link between the manufacturer and the ultimate
consumer. For example, if Company A receives the order and commits to
sell that product only for non-pesticidal uses, it is unclear how
Company A could enforce that agreement on its customers. Thus, Company
A may agree not to sell it to Company B for use as a pesticide, but if
Company B sells it to Company C for use as a pesticide inert, it is
unlikely that EPA would discover it. Moreover, the most that EPA could
do in that circumstance would be to send an order to Company B
requiring testing. Further, tracking such agreements by reviewing the
source of the end-use registrant's inert ingredient would be extremely
complicated and burdensome for both the Agency and the end-use
registrant.
    If, as a result of comments or further analysis, EPA determines
that orders will be sent to pesticide product registrants (end-use
registrants), recipients may have an additional response option of
claiming a formulator's exemption as discussed in the next section.
    f. Claim a formulator's exemption. A product registrant who
receives an order to test a chemical who purchases the chemical from
another recipient who has agreed to generate the data may be eligible
for a formulator's exemption. EPA will confirm claims of eligibility. A
formulator's exemption would become invalid if the supplier of the
chemical were not to submit the data either individually or jointly
with other recipients.
    g. 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 section 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 will 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.''
    In addition, the Agency does not expect an FFDCA section 408(p)
test order recipient to submit a request to bypass Tier 1 screening as
part of their response to the test order. As indicated in the September
2005 Federal Register notice announcing the Agency's chemical selection
approach and again in the June 2007 Federal Register notice announcing
the availability of the draft list of chemicals for initial screening
under the EDSP, any company subject to a testing requirement under Tier
1 may assert during the comment period for the draft list that the
chemical is an endocrine disruptor and that the Tier 1 EDSP screening
is unnecessary. EPA does not intend to permit chemicals on the draft
list to bypass Tier 1 screening and move directly to Tier 2 testing
without appropriate data to support such an action. As such, EPA
expects that this issue will be addressed in finalizing the list of
chemicals for initial screening, which will occur before any FFDCA
section 408(p) test orders are issued.
    2. Generate the data specified in the test order. As indicated in
their Initial Response Form, the recipient's next step would be to
generate the data specified in the FFDCA section408(p) test order. EPA
currently anticipates that the tests would need to be conducted using
the test protocols that would be attached to the order as background
materials because of the statutory requirement that the test method be
validated. If, however, an order recipient believes a deviation from
the required protocol is needed, they should first consult the Agency
before deviating from the test protocol. All requests should be
submitted with a clear rationale to allow the Agency to evaluate the
request in a timely manner. All protocol variations would be reviewed
by EPA and a response would be sent to the specific order recipient in
a timely fashion.
    In addition, 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 the data specified in the test order. The Agency intends
to adopt 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.
The orders will include requirements on how the data should be
formatted. If EPA were issuing orders today, it is likely the Agency
would require that the submission be

consistent with the following requirements.
    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 should 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 the
requirements for organizing and formatting 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 will provide the public with an
opportunity to comment on the proposed revisions to PR 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 encourages FFDCA section 408(p) test order
recipients to submit completed study profiles and supporting data in an
electronic format (PDF) whether submitting one or several studies. For
more information, go to the electronic data submissions website at
http://www.epa.gov/oppfead1/eds/edsgoals.htm.

    b. Transmittal document. In order for EPA to track the compliance
of each order recipient, each submission in satisfaction of a FFDCA
section 408(p) test order must be accompanied by a transmittal document
that includes the following information:
     Identity of the submitter.
     The date on which the submission package was prepared for
transmittal to EPA.
     Identification of the FFDCA section 408(p) test order
associated with the submission (e.g., the test order number).
     A list of the individual documents included in the
submission.
    c. Individual study or test result documents. Unless otherwise
specified by the Agency, each submission must be in the form of
individual documents or studies. EPA does not anticipate requiring the
resubmission of previously submitted documents absent a specific Agency
request. Instead it would be sufficient for previously submitted
documents to be cited with adequate information to identify the
previously submitted document. EPA would typically expect each study or
document to include the following:
    i. A title page including the following information:
     The title of the study, including identification of the
substance(s) tested and the test name or data requirement addressed.
     The author(s) of the study.
     The date the study was completed.
     If the study was performed in a laboratory, the name and
address of the laboratory, project numbers or other identifying codes.
     If the study is a commentary on or supplement to another
previously submitted study, full identification of the other study with
which it should be associated in review.
     If the study is a reprint of a published document, all
relevant facts of publication, such as the journal title, volume,
issue, inclusive page numbers, and date of publication.
    ii. Upon submission to EPA, each document must be accompanied by a
signed and dated document containing the appropriate statement(s)
regarding any data confidentiality claims as described in the FFDCA
section 408(p) test order.
    iii. A statement of compliance or non-compliance with respect to
GLP standards as required by 40 CFR 160.12, if applicable.
    iv. A complete and accurate English translation must be included
for any information that is not in English.
    4. Request an extension. The FFDCA section 408(p) test order would
identify a due date for completing the data specified and submitting it
to EPA. If an order recipient would like to request an extension of
time to complete the testing, the request should be submitted with a
clear rationale for the extension, and any supporting material, in
order to allow the Agency to properly and timely assess the request.
All such requests would be reviewed by EPA and a response would be sent
to the requester in a timely fashion.
    5. Maintaining records. The FFDCA section 408(p) test order would
identify the records that the recipient should maintain. In general,
the Agency expects recipients to maintain copies of the data and other
information submitted to the Agency. 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 otherwise submit their data in support of a pesticide
registration would be held to the recordkeeping standards in 40 CFR
part 169. Recipients who are not a registrant would also be asked to
maintain records related to the generation of the data as specified in
the order. 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. These records shall be
retained as long as the registration is valid and the producer is in
business, and made available to EPA or its agent for inspection.

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)
allows 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
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 inert ingredient manufacturers/importers, FFDCA section
408(p)(5)(D) allows 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, or believes the time
frame for completing the study is too short). 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.
136a(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. 136a(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.
    EPA has considered two alternative interpretations to resolve this
ambiguity. Under one approach, EPA would interpret the statute such
that the same procedures are applicable to both registrants and other
test order recipients. EPA prefers this approach because it would
simplify the process for both EPA and order recipients. The other
approach would result in different procedures for pesticide registrants
and all other test order recipients based on the disparate requirements
established by FFDCA section 408(p)(5)(C) and (D).
    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. 136a(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. 136a(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
in the appropriate district court at the time the order is issued.
[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