

[Federal Register: December 13, 2007 (Volume 72, Number 239)]
[Notices]               
[Page 70842-70862]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13de07-54]                         

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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.

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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.

[[Page 70843]]

     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 (202) 564-8930. 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 (202) 566-1744, and the 
telephone number for the OPPT Docket is (202) 566-0280. Docket visitors 
are required to show photographic identification, pass through a metal 
detector, and sign the EPA visitor log. All visitor bags are processed 
through an X-ray machine and subject to search. Visitors will be 
provided an EPA/DC badge that must be visible at all times in the 
building and returned upon departure.

FOR FURTHER INFORMATION CONTACT: William Wooge, Office of Science 
Coordination and Policy (OSCP), Mailcode 7201M, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 564-8476; fax number: (202) 564-8482; e-
mail address: wooge.william@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you produce, 
manufacture, use, or import pesticide/agricultural chemicals and other 
chemical substances; or if you are or may otherwise be involved in the 
testing of chemical substances for potential endocrine effects. 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.

[[Page 70844]]

    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

[[Page 70845]]

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

[[Page 70846]]

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

[[Page 70847]]

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.

[[Page 70848]]

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

[[Page 70849]]

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

[[Page 70850]]

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.

[[Page 70851]]

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

[[Page 70852]]

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

[[Page 70853]]

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.

[[Page 70854]]

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

[[Page 70855]]

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

[[Page 70856]]

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

[[Page 70857]]

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

[[Page 70858]]

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

[[Page 70859]]

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 
active ingredients jointly under FFDCA section 408(p) and FIFRA section 
3(c)(2)(B). The procedures discussed above for challenging an FFDCA 
section 408(p) test order are wholly consistent with the procedures 
applicable to FIFRA section 3(c)(2)(B), which similarly limits the 
issues for resolution in any suspension hearing held for failure to 
comply with the order. [See 7 U.S.C. 136a(c)(2)(B)(iv)]. Accordingly, 
EPA believes that for pesticide registrants, pre-enforcement review of 
the test order would be available directly in federal district courts 
under any approach, and based on the plain meaning of the statute, 
would be the only means to obtain judicial review of the validity of 
the test order itself.
    By contrast, FFDCA section 408(p)(5)(D) provides that non-
registrants (manufacturers or importers of inert ingredients) are 
subject to monetary penalties through an enforcement proceeding, using 
the process established by TSCA section 16. Under TSCA section 16, 
civil penalties of up to $25,000 per day may be assessed, after an 
administrative hearing is held on the record in accordance with section 
554 of the Administrative Procedures Act (APA). [15 U.S.C. 2615(a)(1)-
(2)(A)]. Before issuing a final penalty order, EPA must provide notice 
of its intention to assess the penalty, including a draft of the final 
penalty order, and provide the recipient with the opportunity to 
request a hearing within 15 days of the date the notice has been 
received. [15 U.S.C. 2615(a)(2)(A)]. [See also, 40 CFR 22.13-22.14]. 
TSCA section 16 also specifies that the following issues shall be taken 
into account in determining the amount of a civil penalty: The nature, 
circumstances, extent and gravity of the violation(s); the violator's 
ability to pay; the effect on the violator's ability to continue to do 
business; any history of prior violations; the degree of culpability; 
and such other matters as justice may require. [5 U.S.C. 
2615(a)(2)(B)].
    Although neither FFDCA section 408(p) nor TSCA section 16 expressly 
imposes the same restriction on the issues that a non-registrant may 
raise in the penalty hearing, EPA's preferred interpretation of the 
statutes and existing regulations would be to impose a similar 
restriction. In large measure this interpretation turns on the fact 
that, at least for pesticide registrants, FFDCA section 408(p) test 
orders constitute final agency action, and consequently, would be 
subject to review in the appropriate district court. Logically, it 
makes sense to interpret the test order to be final for all parties, as 
the provisions of FFDCA section 408(p)(5)(A) that describe the test 
order do not distinguish between registrants and other test order 
recipients. Moreover, EPA believes that, in general, it would simplify 
matters to have a single set of procedures for all test order 
recipients. Accordingly, pre-enforcement judicial review of the test 
order would be available, and would be the means by which any test 
order recipient would challenge the validity of the test order. As a 
consequence of that interpretation, EPA would interpret TSCA section 16 
to restrict the issues that may be raised in any enforcement hearing to 
whether the test order recipient had violated the test order, as well 
as the appropriate amount of any penalty. This interpretation would be 
consistent with the issues listed in TSCA section 16(a)(2)(B), which do 
not expressly relate to the validity of the underlying requirement.
    Alternatively, EPA could interpret the legal status of the order to 
differ between registrants and non-registrants, based on the procedural 
distinctions created by FFDCA section 408(p)(5)(C) and (D). Under this 
approach, FFDCA section 408(p) test orders would constitute final 
agency action only for pesticide registrants, and only those test 
orders would be subject to pre-enforcement review in federal district 
courts. Accordingly, non-registrants would only be able to challenge 
the provisions of the order in an enforcement proceeding, and would not 
be entitled to pre-enforcement review in district court.

[[Page 70860]]

I. Informal Administrative Review Procedure

    EPA intends to include a provision in the FFDCA section 408(p) test 
order that requires the order recipients to raise any questions or 
challenges concerning the issuance of the test order to the Agency in 
response to the order. EPA would review the issues presented and 
provide a written response within a specified time frame. The Agency 
understands that it would need to respond within sufficient time for 
the order recipient to either comply with the order or determine 
whether to pursue its concerns through judicial review. EPA requests 
comment on whether such a provision would be appropriate, and on the 
appropriate parameters for such a requirement, including the deadline 
for order recipients to initially provide their concerns, and the time 
frame for the Agency's response.

J. Adverse Effects Reporting Requirements

    Under FIFRA section 6(a)(2), pesticide product registrants are 
required to submit adverse effects information about their products to 
the EPA. Among other things, the implementing regulations in 40 CFR 
part 159, subpart D provide registrants with detailed instructions on 
whether, when, and how to report information in the possession of the 
registrant or its agents.
    In addition, under TSCA section 8(c), companies can be required to 
record, retain and in some cases report ``allegations of significant 
adverse reactions'' to any substance/mixture that they produce, import, 
process, or distribute. EPA's TSCA section 8(c) rule requires 
producers, importers, and certain processors of chemical substances and 
mixtures to keep records concerning significant adverse reaction 
allegations and report those records to EPA upon notice in the Federal 
Register or upon notice by letter. The TSCA section 8(c) rule also 
provides a mechanism to identify previously unknown chemical hazards in 
that it may reveal patterns of adverse effects which otherwise may not 
be otherwise noticed or detected. Further information is available 
under 40 CFR part 717.
    Under TSCA section 8(e), U.S. chemical manufacturers, importers, 
processors and distributors are required to notify EPA within 30 
calendar days of new, unpublished information on their chemicals that 
may lead to a conclusion of substantial risk to human health or to the 
environment. The term ``substantial risk'' information refers to that 
information which offers reasonable support for a conclusion that the 
subject chemical or mixture poses a substantial risk of injury to 
health or the environment and need not, and typically does not, 
establish conclusively that a substantial risk exists. For additional 
information about TSCA section 8(e), please go to http://www.epa.gov/oppt/chemtest/pubs/sect8e.htm
.

    EPA does not require duplicate submission of EDSP results under 
FIFRA section 6(a)(2) or TSCA section 8(c) or (e). Any information 
submitted under FIFRA section 6(a)(2) or TSCA section 8(c) or 8(e) 
procedures does not need to be submitted again to satisfy the FFDCA 
section 408(p) test order. The test order recipient should instead 
submit the necessary information to cite to the previously submitted 
information as described earlier in this document.

V. Specific Topics for Commenters

    While interested person are invited to comment on any issue 
discussed in this notice, the Agency would find it particularly helpful 
if interested commenters address the general issues and specific 
questions, set forth below. If, for example, commenters have ideas on 
how the Agency could minimize duplicative testing that are not captured 
in the questions below, the Agency welcomes comments on the general 
issue itself.

A. Minimizing Duplicative Testing

    1. If there are multiple entities who manufacture or import a 
substance for which EDSP data are needed, under what circumstances, if 
any, should EPA send test orders only to a single entity?
    2. When issuing test orders for EDSP data on an active ingredient, 
should EPA issue the test order under the authority of FFDCA section 
408(p), under FIFRA section 3(c)(2)(B), or under both authorities?
    3. When issuing test orders for EDSP data on an inert ingredient, 
should EPA issue the test order under the authority of FFDCA section 
408(p), under FIFRA section 3(c)(2)(B), or under both authorities?

B. Cost Sharing

    What evidence of a willingness to share the cost of generating EDSP 
data should EPA require?

C. Data Compensation

    1. What evidence of a willingness to pay compensation for 
previously submitted EDSP data should EPA require?
    2. Should EPA issue ``catch-up'' FFDCA section 408(p) test orders 
to people who begin to manufacture or import an inert ingredient after 
required EDSP data have been submitted?
    3. If so, at what point (e.g., during registration review) and for 
how long should EPA issue such ``catch-up'' test orders?
    4. What alternatives should EPA consider for the 15-year period 
proposed, and why?

D. Who Should Receive Test Orders?

    1. If EPA relies on FIFRA section 3(c)(2)(B) as an authority to 
require data for an active ingredient, should EPA send the DCI only to 
technical registrants or to all registrants whose products contain the 
active ingredient?
    2. Should EPA 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. How should EPA address the issuance of test orders for an inert 
ingredient that is contained in a ``proprietary mixture''?
    4. After EPA has received compensable EDSP data on an inert 
ingredient, which authority should EPA use to ensure that pesticide 
registrants are buying their inert ingredient only from sources on the 
``Inert Suppliers List'': FIFRA section 3(c)(1)(F) only, FIFRA section 
3(c)(1)(F) and FIFRA section 3(g), or FIFRA section 3(c)(1)(F) and 
FIFRA section 3(c)(2)(B)?

E. How to Identify Potential Recipients of Test Orders

    1. Please suggest an efficient approach to identify potential 
recipients of FFDCA section 408(p) test orders for inert ingredients. 
Please identify any databases that will provide the best information.
    2. Please comment on the preferred mechanism for making the list of 
recipients of FFDCA section 408(p) test orders public.
    3. Please comment on a mechanism to identify entities that should 
have received a test order, but that were not initially identified.
    4. How should EPA evaluate requests for exemptions under FFDCA 
section 408(p)(4)?

F. How to Respond to Test Orders

    1. Is 90 days sufficient time for recipients of a test order to 
respond with their intentions for complying with the order?
    2. Should EPA allow a person to ``fulfill'' the requirements of a 
test order by promising not to manufacture or import an active 
ingredient? An inert ingredient?
    3. Should EPA allow a person to ``fulfill'' the requirements of a 
test order

[[Page 70861]]

on an inert ingredient by promising not to manufacture or import the 
inert ingredient for use in a pesticide product? If so, how would EPA 
enforce such an agreement?

G. Procedural Issues

    1. When should a recipient of a test order for EDSP data on an 
inert ingredient be able to judicially challenge the issuance of the 
order?
    2. Should EPA include an optional or mandatory informal 
administrative review procedure by which a person who wishes to 
judicially challenge the validity of a test order would raise the 
objections first with the Agency?
    3. Should the 90-day response form be mandatory or optional?
    4. Should test protocols be attached to the order and/or posted on 
a website?
    5. Should the Agency establish a website of FFDCA section 408(p) 
test order recipients to facilitate the formation of consortia?

H. Due Process Options

    EPA requests comment on whether the informal administrative review 
procedures (as outlined in this document) would be appropriate. Please 
also comment on the appropriate parameters for such a requirement, 
including the deadline for order recipients to initially provide their 
concerns, and the time frame for the Agency's response.

I. CBI

    Provide comments on how best to address CBI concerns associated 
with notifying HPV inert manufacturers, including the difficulty of 
informing registrants, without disclosing the identity of the inert.

J. Estimated Test Costs and Paperwork Burden

    1. Please provide comments on the estimated test costs and burden 
hours presented in the draft ICR. Explain the basis for your estimates 
in sufficient detail to allow EPA to reproduce the estimates.
    2. Provide comments on the methodology used by EPA to estimate the 
burden for data generation, which is based on the total estimated test 
costs.
    3. Is it reasonable to continue to assume that as much as 35% of 
the test costs represents the paperwork burden?

VI. Statutory and Executive Order Reviews

A. Regulatory Planning and Review

    Under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993, as amended by Executive Order 
13422 on January 18, 2007 (72 FR 2763), this policy statement is 
considered to be a ``significant guidance document'' under the terms of 
the amended Executive Order because this policy might raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the Executive Order. 
Accordingly, EPA notified the Office of Management and Budget (OMB) and 
submitted a draft of this policy to OMB under Executive Order 12866. 
Any changes made in response to OMB recommendations have been 
documented in the docket for this action as required by section 
6(a)(3)(E) of the Executive Order.

B. Paperwork Reduction Act (PRA)

    The information collection requirements described in this document 
have been submitted for review by the OMB under the Paperwork Reduction 
Act, 44 U.S.C. 3501 et seq. Elsewhere in today's Federal Register is a 
separate document that announces the availability of the draft 
Information Collection Request (ICR) document that has been prepared by 
EPA, identified by EPA ICR No. 2249.01). Pursuant to the PRA, the 
Agency is seeking public review and comment on the ICR before it 
submits the ICR to OMB for approval under the PRA. The following is a 
brief summary of the ICR document, which describes the information 
collection activities and EPA's estimated burden in more detail.
    An agency may not conduct or sponsor, and a person is not required 
to respond to a collection of information unless it displays a 
currently valid OMB control number. The OMB control numbers for EPA's 
regulations codified in Chapter 40 of the CFR, after appearing in the 
preamble of the final rule, are listed in 40 CFR part 9, are displayed 
either by publication in the Federal Register or by other appropriate 
means, such as on the related collection instrument or form, if 
applicable. The display of OMB control numbers in certain EPA 
regulations is consolidated in 40 CFR part 9. As a new ICR, the Agency 
does not yet have an OMB control number for this information collection 
activity. Once assigned, EPA will announce the OMB control number for 
this information collection in the Federal Register, and will add it to 
any related collection instruments or forms used.
    Burden under the PRA means the total time, effort, or financial 
resources expended by persons to generate, maintain, retain, disclose 
or provide information to or for a Federal agency. This includes the 
time needed to review instructions; develop, acquire, install, and 
utilize technology and systems for the purposes of collecting, 
validating, and verifying information, processing and maintaining 
information, and disclosing and providing information; adjust the 
existing ways to comply with any previously applicable instructions and 
requirements; train personnel to be able to respond to a collection of 
information; search data sources; complete and review the collection of 
information; and transmit or otherwise disclose the information.
    Under the EDSP, the information collection activities include 
reviewing the order and related instructions, providing the initial 
response, participating in a consortia, generating the data, submitting 
the data, requesting an extension, and maintaining records. As 
described in more detail in the ICR, the total estimated per chemical/
per respondent paperwork burden is 2,649 hours, with an estimated cost 
of $194,252. The total annualized estimated paperwork burden for this 
ICR is 93,655 hours, with an estimated total annual cost of $6,887,418. 
The Agency believes that this is an over estimate because this estimate 
assumes that the respondent actively participates in all potential 
activities, including developing a consortia, generating all of the 
potential data, requesting an extension and submitting the data. The 
Agency also assumed that all of the potential tests currently scheduled 
for validation would be used for each chemical. It is highly unlikely 
that any one respondent would need to participate at this level, or 
that all of the tests would be performed for each respondent.
    Direct your comments on the Agency's need for this information, the 
accuracy of the provided burden estimates, and any suggested methods 
for minimizing respondent burden, including the use of automated 
collection techniques, to EPA using the public docket that has been 
established for the ICR (Docket ID No. EPA-HQ-OPPT-2007-1081). The 
Agency will consider and address comments received on the ICR as it 
develops the final policy and related final ICR.

VII. References

    1. EPA. Endocrine Disruptor Screening and Testing Advisory 
Committee (EDSTAC) Final Report. August 1998. http://www.epa.gov/scipoly/oscpendo/pubs/edspoverview/finalrpt.htm
.

    2. Organization for Economic Cooperation and Development (OECD). 
Final Report of the OECD Workshop on Harmonization of Validation and 
Acceptance Criteria for Alternative

[[Page 70862]]

Toxicological Test Methods. August 1996.

List of Subjects

    Environmental protection, Chemicals, Endocrine disruptors, 
Pesticides and pests, Reporting and recordkeeping.


    Dated: December 7, 2007.
James B. Gulliford,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. E7-24166 Filed 12-12 ndash;07; 8:45 am]

BILLING CODE 6560-50-S
