[Federal Register: April 15, 2009 (Volume 74, Number 71)]
[Notices]
[Page 17559-17579]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15ap09-137]
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Part II
Environmental Protection Agency
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Endocrine Disruptor Screening Program; Policies and Procedures for
Initial Screening; Final List of Initial Pesticide Active Ingredients
and Pesticide Inert Ingredients To Be Screened Under the Federal Food,
Drug, and Cosmetic Act; Notices
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ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2007-1080; FRL-8399-9]
RIN 2070-AD61
Endocrine Disruptor Screening Program; Policies and Procedures
for Initial Screening
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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SUMMARY: This document describes the policies and procedures EPA
generally intends to adopt for initial screening of chemicals under the
Endocrine Disruptor Screening Program (EDSP). The EDSP is established
under section 408(p) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), which requires endocrine screening of all pesticide chemicals
and was established in response to growing scientific evidence that
humans, domestic animals, and fish and wildlife species have exhibited
adverse health consequences from exposure to environmental chemicals
that interact with their endocrine systems. In December 2007, EPA
sought comment on its draft policies and procedures for initial
screening under the EDSP. Following review and revision based on the
public comments, EPA is now describing the specific details of the
policies and procedures that EPA generally intends to adopt for initial
screening under the EDSP, including the statutory requirements
associated with and format of the test orders, as well as EPA's
procedures for fair and equitable sharing of test costs and handling
confidential data.
FOR FURTHER INFORMATION CONTACT: William Wooge, Office of Science
Coordination and Policy (OSCP), Mailcode 7201M, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (202) 564-8476; fax number: (202) 564-8482; e-
mail address: wooge.william@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you produce,
manufacture, use, or import pesticide/agricultural chemicals and other
chemical substances; or if you are or may otherwise be involved in the
testing of chemical substances for potential endocrine effects.
Potentially affected entities, identified by the North American
Industrial Classification System (NAICS) codes, may include, but are
not limited to:
Chemical manufacturers, importers and processors (NAICS
code 325), e.g., persons who manufacture, import or process chemical
substances.
Pesticide, fertilizer, and other agricultural chemical
manufacturing (NAICS code 3253), e.g., persons who manufacture, import
or process pesticide, fertilizer and agricultural chemicals.
Scientific research and development services (NAICS code
5417), e.g., persons who conduct testing of chemical substances for
endocrine effects.
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. To determine whether you or your business may be affected by
this action, you should carefully examine the applicability provisions
in Unit IV.E. of this document, and examine section 408(p) of the
FFDCA. If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established a docket for this action under
docket identification (ID) number EPA-HQ-OPPT-2007-1080. All documents
in the docket are listed in the docket's index available at http://
www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, will be publicly
available only in hard copy. Publicly available docket materials are
available electronically at http://www.regulations.gov, or, if only
available in hard copy, at the OPPT Docket. The OPPT Docket is located
in the EPA Docket Center (EPA/DC) at Rm. 3334, EPA West Bldg., 1301
Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room
hours of operation are 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding Federal holidays. The telephone number of the EPA/DC Public
Reading Room is (202) 566-1744, and the telephone number for the OPPT
Docket is (202) 566-0280. Docket visitors are required to show
photographic identification, pass through a metal detector, and sign
the EPA visitor log. All visitor bags are processed through an X-ray
machine and subject to search. Visitors will be provided an EPA/DC
badge that must be visible at all times in the building and returned
upon departure.
2. Electronic access. In addition to accessing the public docket
for this document through www.regulations.gov, you can access other
information about the EDSP through the Agency's website at http://
www.epa.gov/scipoly/oscpendo/index.htm. You may also access this
Federal Register document electronically through the EPA Internet under
the ``Federal Register'' listings at http://www.epa.gov/fedrgstr.
II. Overview
A. What Action is the Agency Taking?
Following review of public comments received on the Draft Policy
and Procedures in response to the Federal Register notice of December
13, 2007 (72 FR 70842) (FRL-8340-3), EPA is describing the policies and
procedures it generally intends to use to issue and enforce orders
pursuant to the authority provided by section 408(p)(5) of the Federal
Food, Drug, and Cosmetic Act (FFDCA). This document provides specific
details on the requirements associated with section 408(p) of FFDCA,
format of the orders, and the associated Agency policies and
procedures. This document also describes the actions and/or procedures
that EPA intends to use to:
Minimize duplicative testing (see Unit IV.C.).
Promote fair and equitable sharing of test costs (see Unit
IV.C.).
Address issues surrounding data compensation (see Unit
IV.C.) and confidentiality (see Unit IV.D.).
Determine to whom orders would generally be issued (see
Unit IV.E.).
Identify how order recipients should respond to FFDCA
section 408(p) test orders, including procedures for challenging the
orders (see Unit IV.F. and H.).
Ensure compliance with FFDCA section 408(p) test orders
(see Unit IV.G.).
This document only addresses the procedural framework applicable to
EPA's implementation of FFDCA section 408(p)(5), and it does not
address the tests or assays that will be used to screen chemicals for
their potential to interact with the endocrine system or the approach
for selecting chemicals under the EDSP. Elsewhere in today's Federal
Register, the Agency is publishing a document that presents the final
list of the first group of chemicals to undergo Tier 1 screening.
[[Page 17561]]
B. Does this Document Contain Binding Requirements?
This document describes the administrative policies and procedures
that EPA generally intends to use in implementing the EDSP for initial
screening. While the requirements in the statutes and the orders are
binding on EPA and the order recipients, this document does not impose
any binding requirements. Although EPA tried to develop policies that
could be used in subsequent data collection efforts, these policies may
be modified in response to the Agency's experience during initial
screening. The policies outlined in this document are intended to
further the general goals of the program, and to the extent the
policies need to be amended to further those programmatic goals, EPA
may do so. The policies and procedures presented in this document are
not intended to be binding on either EPA or any outside parties, and
EPA may depart from the policies and procedures presented in this
document where circumstances warrant and without prior notice.
C. What is the Endocrine Disruptor Screening Program (EDSP)?
The EDSP was established in 1998 to carry out the mandate in
section 408(p) of the FFDCA (21 U.S.C. 346a et. seq.), which directed
EPA ``to develop a screening program . . . to determine whether certain
substances may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or such other endocrine
effect as the Administrator may designate.'' If a substance is found to
have an endocrine effect on humans, FFDCA section 408(p)(6) directs the
Administrator to take action under available statutory authority to
ensure protection of public health. That is, the ultimate purpose of
the EDSP is to provide information to the Agency that will allow the
Agency to evaluate the risks associated with the use of a chemical and
take appropriate steps to mitigate any risks (Ref. 1). The necessary
information includes identifying any adverse effects that might result
from the interaction of a substance with the endocrine system and
establishing a dose-response curve (Ref. 1). Section 1457 of the Safe
Drinking Water Act (SDWA) also authorizes EPA to screen substances that
may be found in sources of drinking water, and to which a substantial
population may be exposed, for endocrine disruption potential. (42
U.S.C. 300j-17).
The Agency first proposed the basic components of the EDSP on
August 11, 1998 (63 FR 42852) (FRL-6021-3). After public comments,
external consultations and peer review, EPA provided additional details
on December 28, 1998 (63 FR 71542) (FRL-6052-9). The design of the EDSP
was based on the recommendations of the Endocrine Disruptor Screening
and Testing Advisory Committee (EDSTAC), which was chartered under the
Federal Advisory Committee Act (FACA) (5 U.S.C. App.2, 9(c)). The
EDSTAC was comprised of members representing the commercial chemical
and pesticides industries, Federal and State agencies, worker
protection and labor organizations, environmental and public health
groups, and research scientists. EDSTAC recommended that EPA's program
address both potential human and ecological effects; examine effects on
estrogen, androgen, and thyroid hormone-related processes; and include
non-pesticide chemicals, contaminants, and mixtures in addition to
pesticides (Ref. 1). In addition, because of the large number of
chemicals that might be included in the program, EDSTAC also
recommended that EPA establish a priority-setting approach for choosing
chemicals to undergo Tier 1 screening. The Science Advisory Board
(SAB)/Scientific Advisory Panel Subcommittee further recommended that
initial screening be limited to 50 to 100 chemicals.
Based on the EDSTAC recommendations, EPA developed a two-tiered
approach to implement the statutory testing requirements. The purpose
of Tier 1 screening (referred to as ``screening'') is to identify
substances that have the potential to interact with the estrogen,
androgen, or thyroid hormone systems using a battery of assays. The
fact that a substance may interact with a hormone system, however, does
not mean that when the substance is used, it will cause adverse effects
in humans or ecological systems. The purpose of Tier 2 testing
(referred to as ``testing''), is to identify and establish a dose-
response relationship for any adverse effects that might result from
the interactions identified through the Tier 1 assays (Ref. 1).
EPA is implementing its EDSP in three major parts developed in
parallel. This document deals only with one component of the EDSP
(i.e., the administrative policies and procedures related to the
issuance of Tier 1 Orders). The three parts are briefly summarized as
follows:
1. Assay validation. Under FFDCA section 408(p), EPA is required to
use ``appropriate validated test systems and other scientifically
relevant information'' to determine whether substances may have
estrogenic effects in humans or other endocrine effects as the
Administrator may designate. Validation is defined as the process by
which the reliability and relevance of test methods are evaluated for
the purpose of supporting a specific use (Ref. 2). The proposed EDSP
Tier 1 Screening Battery of Assays was presented to the FIFRA SAP
during a public meeting on March 25-27, 2008. The FIFRA SAP report
covering the meeting is available at http://www.epa.gov/scipoly/sap/
meetings/2008/march/minutes2008-03-25.pdf. The final Tier 1 battery
will be announced in a separate Federal Register document that the
Agency anticipates issuing in spring 2009. EPA is also in the process
of developing and validating Tier 2 tests. The status of each assay can
be viewed on the EDSP website in the Assay Status table: http://
www.epa.gov/scipoly/oscpendo/pubs/assayvalidation/status.htm.
2. Priority setting. EPA described its priority setting approach to
select pesticide chemicals for initial screening on September 27, 2005
(70 FR 56449) (FRL-7716-9), and announced the draft list of initial
pesticide active ingredients and pesticide inerts to be considered for
screening under FFDCA on June 18, 2007 (72 FR 33486) (FRL-8129-3). The
first group of pesticide chemicals to undergo screening is also
referred to as ``initial screening'' in this document. The Agency is
publishing in today's Federal Register a final list of chemicals that
will be subject to initial screening. EPA anticipates that it may, in
the future, modify its approach to selecting chemicals for screening.
Information and factors that EPA may consider in selecting chemicals
could include: Public input; the results of testing chemicals on the
initial list; management considerations to increase the integration of
screening with other regulatory activities within the Agency;
implementation considerations flowing from a decision to extend
screening to additional categories of chemicals (e.g., non-pesticide
chemical substances); and the availability of new priority setting
tools (e.g., High Throughput Pre-screening or Quantitative Structure
Activity Relationships models). More information on EPA's priority
setting approach and the list of chemicals is available at http://
www.epa.gov/scipoly/oscpendo/pubs/prioritysetting.
3. Procedures. This Federal Register document describes the
administrative policies and procedures that EPA generally intends to
use in implementing the EDSP for initial screening. Specifically, the
general policies and procedures relating to:
[[Page 17562]]
The issuance of FFDCA 408(p) testing orders.
Responses and related activities for order recipients to
use in responding to an order.
Joint data development, cost sharing, data compensation,
and data protection.
Other related procedures or policies.
D. What Chemicals May Be Covered by the EDSP?
FFDCA section 408(p)(3) specifically requires that EPA ``shall
provide for the testing of all pesticide chemicals.'' Section 201 of
FFDCA defines ``pesticide chemical'' as ``any substance that is a
pesticide within the meaning of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), including all active and pesticide inert
ingredients of such pesticide.'' (FFDCA section 201(q)(1), 21 U.S.C.
231(q)(1) (Note that section 201(q) contains certain minor exceptions
that do not affect these policies and procedures.)). Active ingredients
are the substances that prevent, repel, suppress, control or kill the
target pests. (FIFRA section 2(a); 7 U.S.C. 136(a)) Pesticide inert
ingredients (also referred to as ``other pesticide ingredients'') are
any ingredients in a pesticide product that are not active. (FIFRA
section 2(m); 7 U.S.C. 136(m)). Pesticide inert ingredients may simply
dilute the active ingredient or they may perform some function such as
allowing the product to adhere better to leaves or other surfaces to
improve contact with the pests. Pesticide inert ingredients also
include fragrances, which may mask the smell of residential pesticides,
and odorizers, which may act as warning agents. Many of these
chemicals, including both pesticide active and inert ingredients, also
have other, non-pesticidal uses.
FFDCA also provides EPA with discretionary authority to ``provide
for the testing of any other substance may have an effect that is
cumulative to an effect of a pesticide chemical if the Administrator
determines that a substantial population may be exposed to such a
substance.'' (21 U.S.C. 346a(p)(3)).
In addition, EPA may provide for the testing of ``any other
substance that may be found in sources of drinking water if the
Administrator determines that a substantial population may be exposed
to such substance.'' (SDWA section 1457, 42 U.S.C. 300j-17).
Lastly, it is important to clarify that the procedures and policies
described in this document do not in any way limit the Agency's use of
other authorities or procedures to require testing of chemicals for
endocrine disruptor effects. For example, section 4 of the Toxic
Substances Control Act (TSCA) provides EPA with the authority to
require testing of TSCA chemical substances, provided that the Agency
makes certain risk and/or exposure findings. (15 U.S.C. 2603).
Similarly, section 3(c)(2)(B) of FIFRA grants EPA the authority to
require pesticide registrants to submit additional data that EPA
determines are necessary to maintain an existing registration. (7
U.S.C. 136a(c)(2)(B)).
As discussed in EPA's priority setting approach for the EDSP (70 FR
56449, September 27, 2005), the Agency is initially focusing its
chemical selection on pesticide chemicals, both active ingredients and
high production volume chemicals used as a pesticide inert ingredient
in pesticides. If chemicals identified for future screening and testing
under the EDSP are not used in pesticides, the Agency intends to
consider whether the policies and procedures identified in this
document would be appropriate for other categories of substances.
E. How Will EDSP Data be Used?
In general, EPA intends to use the data collected under the EDSP,
along with other information, to determine if a pesticide chemical, or
other substances, may pose a risk to human health or the environment
due to disruption of the endocrine system. The determination that a
chemical does or is not likely to have the potential to interact with
the endocrine system (i.e., disruption of the estrogen, androgen, or
thyroid hormone systems) will be made on a weight-of-evidence basis
taking into account data from the Tier 1 assays and/or other
scientifically relevant information.
Chemicals that go through Tier 1 screening and are found to have
the potential to interact with the estrogen, androgen, or thyroid
hormone systems will proceed to the next stage of the EDSP where EPA
will determine which, if any, of the Tier 2 tests are necessary based
on the available data. Tier 2 testing is designed to identify any
adverse endocrine-related effects caused by the substance, and
establish a quantitative relationship between the dose and that
endocrine effect.
III. Authority
A. What is the Statutory Authority for the Policies Discussed in this
Document?
FFDCA section 408(p)(1) requires EPA ``to develop a screening
program, using appropriate validated test systems and other
scientifically relevant information to determine whether certain
substances may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or such other effects as
[EPA] may designate.'' (21 U.S.C. 346a(p)).
FFDCA section 408(p)(3) expressly requires that EPA ``shall provide
for the testing of all pesticide chemicals.'' FFDCA section 201 defines
``pesticide chemical'' as ``any substance that is a pesticide within
the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), including all active and pesticide inert ingredients of such
pesticide.'' (FFDCA section 201(q)(1), 21 U.S.C. 231(q)(1)). The
statute also provides EPA with discretionary authority to ``provide for
the testing of any other substance that may have an effect that is
cumulative to an effect of a pesticide chemical if the Administrator
determines that a substantial population may be exposed to such a
substance.'' (21 U.S.C. 346a(p)(3)).
FFDCA section 408(p)(5)(A) provides that the Administrator ``shall
issue an order to a registrant of a substance for which testing is
required [under FFDCA section 408(p)], or to a person who manufactures
or imports a substance for which testing is required [under FFDCA
section 408(p)], to conduct testing in accordance with the screening
program, and submit information obtained from the testing to the
Administrator within a reasonable time period'' that the Agency
determines is sufficient for the generation of the information.
FFDCA section 408(p)(5)(B) requires that, ``to the extent
practicable, the Administrator shall minimize duplicative testing of
the same substance for the same endocrine effect, develop, as
appropriate, procedures for fair and equitable sharing of test costs,
and develop, as necessary, procedures for handling of confidential
business information. . . .'' (21 U.S.C. 346a (p)(5)(B)).
If a registrant fails to comply with a FFDCA section 408(p)(5) test
order, the Administrator is required to issue ``a notice of intent to
suspend the sale or distribution of the substance by the registrant.
Any suspension proposed under this paragraph shall become final at the
end of the 30-day period beginning on the date that the registrant
receives the notice of intent to suspend, unless during that period, a
person adversely affected by the notice requests a hearing or the
Administrator determines that the registrant has complied fully with
this paragraph.'' (21 U.S.C. 346a (p)(5)(C)). Any hearing is required
to be conducted in accordance
[[Page 17563]]
with section 554 of the Administrative Procedures Act (APA). (5 U.S.C.
554). FFDCA section 408(p) explicitly provides that ``the only matter
for resolution at the hearing shall be whether the registrant has
failed to comply with a test order under subparagraph (A) of this
paragraph.'' (21 U.S.C. 346a (p)(5)(C)(ii)). A decision by the
Administrator after completion of a hearing is considered to be a final
Agency action. (21 U.S.C. 346a (p)(5)(C)(ii)). The Administrator shall
terminate a suspension issued with respect to a registrant if the
Administrator determines that the registrant has complied fully with
FFDCA section 408(p)(5). (21 U.S.C. 346a (p)(5)(C)(iii)).
FFDCA section 408(p)(5)(D) provides that any person (other than a
registrant) who fails to comply with a FFDCA section 408(p)(5) test
order shall be liable for the same penalties and sanctions as are
provided for under TSCA section 16. (21 U.S.C. 346a (p)(5)(D)). Such
penalties and sanctions shall be assessed and imposed in the same
manner as provided in TSCA section 16. Under section 16 of TSCA, civil
penalties of up to $25,000 per day may be assessed, after notice and an
administrative hearing held on the record in accordance with section
554 of the APA. (15 U.S.C. 2615(a)(1)-(2)(A)).
B. Other Statutory Authorities Relevant to this Notice
A number of other statutory provisions are discussed in this
document, and consequently, are described below. This document does not
reopen in any way or otherwise affect the existing policies or related
procedures that have been established under these other provisions. The
following is a brief summary of these other relevant authorities.
1. FIFRA. FIFRA section 3(c)(1)(F) provides certain protections for
people who submit data to EPA in connection with decisions under EPA's
pesticide regulatory program. Specifically, FIFRA section 3(c)(1)(F)
confers ``exclusive use'' or ``data compensation'' rights on certain
persons (``original data submitters'') who submit data (in which they
have an ownership interest), in support of an application for
registration, reregistration, or experimental use permit, or to
maintain an existing registration. Applicants who cite qualifying data
previously submitted to the Agency by the original data submitter must
certify that the original data submitter has granted permission to the
applicant to cite data or that the applicant has made an offer of
compensation to the original data submitter. In the case of ``exclusive
use'' data, the applicant must obtain the permission of the original
data submitter and certify to the Agency that the applicant has
obtained written authorization from the original data submitter. (Data
are generally entitled to ``exclusive use'' for 10 years after the date
of the initial registration of a pesticide product containing a new
active ingredient.) If data are not subject to exclusive use but are
compensable, an applicant may cite the data without the permission of
the original data submitter, so long as the applicant offers to pay
compensation for the right to rely on the data. (Data are
``compensable'' for 15 years after the date on which the data were
originally submitted.) If an applicant and an original data submitter
cannot agree on the appropriate amount of compensation, either may
initiate binding arbitration to reach a determination. If an applicant
fails to comply with either the statutory requirements or the
provisions of a compensation agreement or an arbitration decision, the
application or registration is subject to denial or cancellation. (See
also 7 U.S.C. 136a (c)(1)(F)(ii)-(iii)).
FIFRA section 3(c)(2)(B) provides that:
. . . [i]f the Administrator determines that additional data are
required to maintain in effect an existing registration of a
pesticide, the Administrator shall notify all existing registrants
of the pesticide to which the determination relates and provide a
list of such registrants to any interested person. (7 U.S.C.
136a(c)(2)(B)).
Continued registration of a pesticide requires that its use not result
in ``unreasonable adverse effects on the environment'' defined as:
. . . (1) any unreasonable risk to man or the environment,
taking into account the economic, social, and environmental cost and
benefits of the use of any pesticide, or (2) a human dietary risk
from residues that results from a use of a pesticide in or on any
food inconsistent with the standard under section 408 of the
[FFDCA]. (7 U.S.C. 136 (bb)).
FIFRA section 3(c)(2)(B) contains a mechanism by which recipients
of notices of data requirements (referred to as ``Data Call-In
notices'' or ``DCI notices'') may jointly develop data and provides
that ``[a]ny registrant who offers to share in the cost of producing
the data shall be entitled to examine and rely upon such data in
support of maintenance of such registration.'' The section establishes
procedures to allow registrants who received DCI notices to use binding
arbitration to resolve disputes about each person's fair share of the
testing costs.
Further, FIFRA section 3(c)(1)(F) makes clear that data submitted
under FIFRA section 3(c)(2)(B) are also ``compensable'' when cited in
support of an application for a registration. In other words, a
pesticide company that chooses to rely on such data rather than develop
its own data must offer compensation to the original data submitter-
usually the data generator. Lastly, the Agency may suspend the
registration of a pesticide if the registrant fails to take appropriate
steps to provide data required under a DCI notice in a timely manner.
Finally, FIFRA section 3(c)(2)(D) contains a provision, referred to
as the ``formulator's exemption'' that is intended to simplify and
promote equity in the implementation of the data compensation program
under FIFRA section 3(c)(1)(F). This exemption relieves an applicant of
the obligation to submit a study, or to cite and obtain permission or
offer to pay data compensation to cite the results of a study if the
study is relevant to the safety assessment of a registered product that
the applicant buys from another person and uses to make the applicant's
product. Congress' rationale for this exemption is that the seller will
recover any data generation costs through the purchase price of its
product. Thus, if a pesticide formulator applies to register a product
containing an active ingredient that the formulator purchased from the
basic manufacturer of the active ingredient, the formulator does not
need to submit or cite and offer to pay compensation for any data
specifically relevant to the purchased product. The Agency has extended
the principles of the formulator's exemption to data requirements under
FIFRA section 3(c)(2)(B). Consequently, if the formulator received a
DCI notice requiring data on the active ingredient, the formulator
could comply by providing documentation that it bought the active
ingredient from another registrant.
2. SDWA. SDWA section 1457 provides EPA with discretionary
authority to require testing, under the FFDCA section 408(p) screening
program, ``of any other substances that may be found in sources of
drinking water if the Administrator determines that a substantial
population may be exposed to such substance.'' (42 U.S.C. 300j-17).
Because SDWA section 1457 specifically mandates that EPA ``may provide
for testing. . . in accordance with the provisions of [FFDCA section
408(p)],'' EPA may rely on many of the procedures discussed in this
document to require testing under SDWA section 1457.
[[Page 17564]]
3. Other sections of FFDCA. FFDCA section 408(f) establishes
procedures that the Agency ``shall use'' to require data to support the
continuation of a tolerance or exemption that is in effect. The
provision identifies three options:
Issuance of a notice to the person holding a pesticide
registration under FIFRA section 3(c)(2)(B) (FFDCA section
408(f)(1)(A)).
Issuance of a rule under section 4 of TSCA (FFDCA section
408(f)(1)(B)).
Publication of a notice in the Federal Register requiring
submission, by certain dates, of a commitment to generate the data ``by
one or more interested persons.'' (FFDCA section 408(f)(1)(C)).
Before using the third option, however, EPA must demonstrate why
the data ``could not be obtained'' using either of the first two
options. FFDCA section 408(f)(1) expressly provides that EPA may use
these procedures to ``require data or information pertaining to whether
the pesticide chemical may have an effect in humans that is similar to
an effect produced by a naturally occurring estrogen or other endocrine
effects.'' Finally, FFDCA section 408(f)(1)(B) provides that, in the
event of failure to comply with a rule under TSCA section 4 or an order
under FFDCA section 408(f)(1)(C), EPA may, after notice and opportunity
for public comment, modify or revoke any tolerance or exemption to
which the data are relevant.
In addition, FFDCA section 408(i) provides that ``[d]ata that are
or have been submitted to the Administrator under this section or FFDCA
section 409 in support of a tolerance or an exemption from a tolerance
shall be entitled to confidential treatment for reasons of business
confidentiality and to exclusive use and data compensation to the same
extent provided by section 3 and section 10 of [FIFRA].''
IV. Policies and Procedures for Initial Screening Under the EDSP
This Unit describes the policies and procedures that EPA generally
intends to adopt for the initial screening required under the EDSP. In
general, the Agency has tried to develop policies that could be used in
subsequent data collection efforts, including those under SDWA.
However, these policies and procedures may be modified as a result of
the Agency's experience applying them to the first chemicals to undergo
screening and testing under the EDSP. In addition, EPA may modify these
policies and procedures during the initial screening as circumstances
warrant.
A. Background
On December 13, 2007 (72 FR 70842), EPA announced availability of
and solicited public comment on EPA's draft policies and procedures for
initial screening under the EDSP. EPA held two public workshops, one on
December 17, 2007, and another on February 28, 2008, to discuss the
proposed policies and procedures with stakeholders. Following review
and revision based on the public comments, EPA is now describing the
specific details of the policies and procedures that EPA generally
intends to use for initial screening under the EDSP.
After reviewing all of the public comments received, EPA has
decided to make some changes and/or clarifications to the draft
policies and procedures. The Agency's responses to public comments are
discussed in more detail in the document entitled Response to Comments
on the Endocrine Disruptor Screening Program: Draft Policies and
Procedures for Initial Screening and Testing (Ref. 3), a copy of which
is in the docket. The following is a discussion of the major changes
and/or clarifications to the policies and procedures.
1. Modified the response options for inerts. The Agency originally
proposed to relieve a manufacturer or importer of a pesticide inert
ingredient of the requirement to generate EDSP data only if the
manufacturer or importer agreed to discontinue selling and distributing
the ingredient for any use, whether the use was as a pesticide inert
ingredient in a pesticide product or for a non-pesticidal purpose. As
explained more fully in its Response to Comments document, after
considering all of the comments, EPA is persuaded that it should change
the EDSP initial screening policies and procedures and allow a
manufacturer or importer to comply with an order by agreeing to
discontinue sale of the chemical into the pesticide market. This change
leads to other modifications to the procedures to ensure effective
enforcement of data use protections as well as maintaining a ``level
playing field.''
Specifically, EPA intends to establish a Pesticide Inert
Ingredients Data Submitters & Suppliers List (PIIDSSL) to identify any
entity who has submitted compensable data on a pesticide inert
ingredient in response to a test order issued under section 408(p).
Pursuant to FIFRA section 3(c)(1)(F), when a new pesticide registration
applicant's product contains a pesticide inert ingredient on the
PIIDSSL, EPA intends to require the applicant to identify the source of
the pesticide inert ingredient. If the applicant's source does not
appear on the PIIDSSL, EPA intends to require the applicant either to
switch to a source on the PIIDSSL; offer to pay compensation to the
original data submitter(s) on the PIIDSSL; or generate their own data
to support their application.
The Agency also intends to continue to issue ``catch-up'' orders to
any manufacturer or importer of a pesticide inert ingredient who enters
the market place after EPA receives data in response to an initial test
order for that ingredient. The Agency thinks that the combination of
procedures-issuance of ``catch-up'' orders and establishment of the
PIIDSSL-will result in a system that effectively provides data use
protections to generators of endocrine data on pesticide inert
ingredients. EPA agrees that industry will have a strong interest in
self-policing to ensure that competitors are not reneging on their
commitment not to sell to the pesticide market and EPA accepts the
commenters' claims that the industry can effectively identify for EPA
any companies that do not abide by a commitment to cease sales into the
pesticide market. However, in the event that significant problems
arise, EPA intends to reevaluate this policy, along with evaluating
options for responding. For example, EPA considers that reexamination
of this policy would be warranted if all manufacturers of a particular
inert ingredient opted out of the pesticide market, given the likely
impact this would have on end-use formulators. Another consideration
would be if EPA discovers that these measures are ineffective at
keeping the chemical out of the pesticide market. Under those
circumstances, EPA may consider reissuing FFDCA section 408(p) orders
to the original manufacturers, with the requirement that the
manufacturers and importers provide data in response to the order
unless they agree to cease entirely all manufacture or importation of
the chemical. EPA may also consider issuing orders to end-use
registrants, if circumstances warrant.
2. Catch-up orders. The Agency intends to issue ``catch-up'' orders
for 15 years after the initial test order(s) for the chemical is
issued.
3. Clarifications. The Agency has provided additional
clarifications, including the policies and statutory interpretations
relating to pre-enforcement review and informal administrative review,
and the procedures related to the citation or submission of other
scientifically relevant information.
[[Page 17565]]
4. Paperwork activities and estimates. The Agency has also revised
the Initial Response Form and the templates for Tier 1 Orders, as well
as the related estimated paperwork burden and costs.
B. Testing of Pesticide Chemicals Under the EDSP
For the initial screening, EPA generally intends to issue ``Tier 1
Orders'' pursuant to section 408(p)(5) of FFDCA. This is consistent
with the December 1998 Notice, where EPA indicated that it intended to
rely primarily on FFDCA and SDWA to require testing, and would ``use
other testing authorities under FIFRA and TSCA to require the testing
of those chemical substances that the FFDCA and SDWA do not cover.''
(Ref. 1). Because EPA is focusing on pesticide chemicals in registered
pesticide products for initial screening, there is no need to rely on
TSCA or SDWA. However, as discussed in Unit IV.C.-IV.D., in order to
address some of the more complex issues surrounding joint data
development and the availability of data compensation and data
protection, EPA intends to issue some orders jointly under the
authority of FFDCA section 408(p)(5) and FIFRA section 3(c)(2)(B). A
diagram that graphically depicts the overall process is available in
the docket.
The Agency has developed two templates for the Tier 1 Orders that
reflect the policies and procedures discussed in this document, and
which outline the basic framework that EPA generally intends to use to
issue orders for the EDSP initial screening. The test orders differ
according to whether the recipient is a: (1) Pesticide registrant, or
(2) manufacturer and/or importer of a pesticide inert ingredient (aka
``other ingredient''). In addition, the templates accommodate
differences in the Agency's procedures for data compensation, and for
the minimization of duplicative data, which varies based on the Order
recipient. Copies of the Tier 1 Order templates are included in the
docket.
There are some pesticide active and pesticide inert ingredients
that are not registered in the U.S. but for which there are tolerances
on foods imported from other countries. When these chemicals are to be
tested in the future, EPA may rely on FFDCA 408(f)(1) to require
``interested persons'' to submit data for the EDSP.
C. What is EPA Doing To Minimize Duplicative Testing and Promote Cost
Sharing and Data Compensation Under EDSP?
One of the complex issues discussed in the December 1998 Notice
related to joint data development, and how EPA would implement the
FFDCA section 408(p)(5)(B) directive that ``[t]o the extent
practicable, the Administrator shall minimize duplicative testing of
the same substance for the same endocrine effect. . . .'' As noted in
the December 1998 Notice (63 FR 71563), EPA originally contemplated
that it would adopt new procedures unique to the EDSP.
After considering public comment on its 2007 Draft Policies and
Procedures (72 FR 70842), EPA is adopting an approach that follows
closely the draft procedures to promote cost sharing and data
compensation described in the December 2007 document.
EPA's approach to ``minimize duplicative testing of the same
substance'' and to promote the ``fair and equitable sharing of test
costs'' is intended to achieve the following goals essentially the same
outcome for all inert ingredients as the outcome the procedures under
FIFRA section 3(c)(2)(B) and section 3(c)(1)(F) produce for active
ingredients. That is:
The companies who are the basic producers of an active
ingredient or pesticide inert ingredient would typically bear the costs
of testing. Those who purchase a pesticide inert ingredient from a
basic producer (who becomes/is an original data submitter) or another
``approved inert supplier'' would not typically have to participate in
joint development of, or offer to pay compensation for the right to
rely on, required EDSP data. See Unit IV.C.3.c.
The recipients of the FFDCA section 408(p) test orders
have a mechanism to resolve disputes and enforce agreements to develop
data jointly and to share test costs. See Unit IV.C.1.b.
Subsequent entrants into the marketplace are, for an
appropriate period of time, subject to the same data requirements, with
provisions that would allow them to share the test costs rather than
submit duplicative data. See Unit IV.C.2.
The recipients of the FFDCA section 408(p) test orders may
cite or submit existing data (i.e., other scientifically relevant
information) in lieu of developing new data, and ask EPA to determine
whether the information can be used to satisfy part or all of the Tier
1 Order and/or otherwise inform the Tier 1 determination. See Unit
IV.C.1.c.
EPA believes its approach will achieve essentially the same outcome
for all inert ingredients as the outcome the procedures under FIFRA
section 3(c)(2)(B) and section 3(c)(1)(F) produce for active
ingredients.
In summary, EPA generally intends to adopt a policy that encourages
data developers to join forces and agree on how to share costs, and
that also encourages companies entering the marketplace after the data
are developed to pay reasonable compensation to those that developed
the data. To the extent permitted by FFDCA, EPA's intended policies and
procedures for EDSP resembles the policies and procedures used for
Data-Call-Ins under FIFRA.
1. Minimizing duplicative testing. As a point of clarification, a
substantial amount of overlap exists between the goal of minimizing
duplicative testing and the topic discussed in the next unit, allowing
parties to share the costs of conducting the tests. Consequently, some
of the measures discussed in this unit to minimize duplicative testing
will have certain implications for the decisions pertaining to cost
sharing, and vice versa.
In developing its policy and procedures, EPA draws on years of
experience with pesticide registrants. This experience has shown that
reducing the costs of complying with a test order is a powerful
incentive in bringing companies together to jointly develop and submit
data. However, there may also be disincentives to joint data
development including the costs of organizing a consortium. EPA policy
and procedures are primarily designed to minimize the disincentives.
a. Recipients of 408(p) test orders. The Agency recognizes that, as
the number of recipients of test orders increases, organizational costs
also increase. EPA must balance the second goal mentioned in FFDCA
section 408(p)(5)(B)--promoting ``fair and equitable sharing of test
costs''--with the organizational costs of a large number of order
recipients. As is discussed more fully in Unit IV.E., under FFDCA
section 408(p), EPA may issue orders to pesticide registrants or
manufacturers and importers. While EPA could issue orders to all the
interested parties, including the registrants of end-use products
containing the active or inert ingredient this would greatly expand the
number of order recipients and complicate the organization of
consortia. Under FIFRA, data generation is typically undertaken by the
technical registrant, who is also a producer or importer of the
chemical. EPA generally
[[Page 17566]]
intends to issue FFDCA 408(p) test orders to the basic producers of
active or inert ingredients, balancing the goal of fairness with the
need to keep the number of recipients low to avoid high organizational
costs.
Further, by issuing orders to manufacturers and importers of inert
ingredients, EPA is able to avoid the confidentiality issues associated
with inert ingredients. Most manufacturers claim their inert
ingredients to be confidential; accordingly, EPA cannot reveal the
inert ingredients in pesticide products and therefore generally could
not reveal the companies to whom an order was issued. By issuing orders
to manufacturers and importers, EPA can, with few exceptions,
immediately inform a recipient of the identity of all other recipients,
facilitating communication and the formation of a consortium.
b. Resolving disputes and enforcing agreements. As described in the
December 2007 Draft Policy and Procedures, the Agency has concluded
that FFDCA section 408(p)(5) does not provide the authority to create
requirements for joint data development, including a requirement to use
binding arbitration to resolve disputes, as does FIFRA section 3. In
EPA's view, FFDCA section 408(p)(5)(B) merely establishes a qualified
direction that the Agency ``[t]o the extent practicable . . . minimize
duplicative testing . . . .'' This, standing alone, does not create new
authority to compel companies to use arbitration to resolve disputes
arising from an effort to develop data jointly, nor does it even
authorize EPA to impose a requirement for joint data development.
Rather, EPA believes that this provision directs the Agency to create
procedures that operate within the confines of existing statutory
authorities.
While FFDCA section 408(p) does not allow EPA to impose
requirements identical to those authorized by FIFRA section 3, EPA has
the authority under FFDCA section 408(p) to develop Agency procedures
that would facilitate joint data generation. Specifically, the Agency
has discretion to determine what actions constitute compliance with a
FFDCA section 408(p) test order, and EPA intends to apply this
discretion in a manner that creates strong incentives for companies to
voluntarily develop data jointly. At the same time, however, each
recipient of an order under FFDCA section 408(p) has a separate
obligation to satisfy the Tier 1 Order that they received. EPA thinks
that FFDCA section 408(p) confers adequate discretion to consider that
a recipient has fulfilled its obligation to provide data when:
The recipient individually or jointly submits results from
the required studies, or
EPA judges that it would be equitable to allow the
recipient to rely on, or cite, results of studies submitted by another
person.
The determination of whether it would be equitable to allow
citation to another recipient's data will be necessarily based on a
case-by-case review of the specifics of the individual circumstances.
However, the Agency believes that it would generally be equitable to
allow a recipient of a FFDCA section 408(p) test order to rely on the
results of studies submitted by another person where:
The data generator has given permission to the recipient
to cite the results, or
Within a reasonable period after receiving the FFDCA
section 408(p) test order, the recipient has made an offer to commence
negotiations regarding the amount and terms of paying a reasonable
share of the cost of testing, and has included an offer to resolve any
dispute over the recipients' shares of the test costs by submitting the
dispute to a neutral third party with authority to bind the parties,
(e.g., through binding arbitration).
The Agency believes this approach to minimizing duplicative
testing, which parallels that used under FIFRA section 3(c)(2)(B),
provides all recipients of FFDCA section 408(p) test orders adequate
incentives to develop data jointly. In the first instance, where the
data generator had granted permission for another party to cite its
data, the equities are clear, and EPA has no reason for refusing to
allow it. In the second instance, where the data generator received an
offer to commence negotiations regarding the amount and terms of
compensation and to go to a neutral decisionmaker with authority to
bind the parties failing successful negotiations, EPA believes that the
company has demonstrated a good faith effort to develop data jointly,
and consequently would typically consider that the order recipient had
complied with the order. Based on EPA's experience under FIFRA, there
would be little or no reason for a data generator to decline such an
offer. Moreover, if EPA did not adopt such an approach, the end result
would effectively confer the sort of ``exclusive use'' property rights
established under FIFRA section 3(c)(1)(F), on a broad category of
data, and EPA does not believe that FFDCA section 408(p)(5) creates
such rights, or provides EPA with the authority to create such rights.
These conditions would also apply to recipients of ``catch up''
FFDCA 408(p) orders, who enter the market after the data have been
submitted.
c. Submission/citation of existing data. As under FIFRA, EPA
provides the recipients of FFDCA section 408(p) test orders with the
option of submitting or citing existing data, along with a rationale
that explains how the cited or submitted study satisfies the Tier 1
Order. Existing data may include data that has already been generated
using the assay(s) specified in the Order, or ``other scientifically
relevant information.'' Other scientifically relevant information is
information that informs the determination as to whether the substance
may have an effect that is similar to an effect produced by a substance
that interacts with the estrogen, androgen, and/or thyroid hormonal
systems (e.g., information that identifies substances as having the
potential to interact with the estrogen, androgen, and/or thyroid
system(s); information demonstrating whether substances have an effect
on the functioning of the endocrine system). Other scientifically
relevant information may either be functionally equivalent to
information obtained from the Tier 1 assays--that is, data from assays
that perform the same function as EDSP Tier 1 assays--or may include
data that provide information on a potential consequence or effect that
could be due to effects on the estrogen, androgen or thyroid systems.
Some ``other scientifically relevant information'' may be sufficient to
satisfy part or all of the Tier 1 Order and/or otherwise inform the
Tier 1 determination. The submission or citation of other
scientifically relevant information in lieu of the data specified in
the Order is discussed in Unit IV.F.1.b.
The Agency has written a paper entitled EPA's Approach for
Considering Other Scientifically Relevant Information (OSRI) under the
Endocrine Disruptor Screening Program. (Ref. 4). This paper was
developed by EPA to provide guidance to EPA staff and managers who will
be reviewing the responses to Tier 1 Orders issued under the EDSP, and
may also be of interest to parties considering whether to submit other
scientifically relevant information to EPA. This paper provides general
guidance and is not binding on either EPA or any outside parties.
Anyone may provide other scientifically relevant information, and the
Agency will assess the information for appropriateness on a case-by-
case basis to determine whether the information can be used to satisfy
[[Page 17567]]
part or all of the Tier 1 Order and/or otherwise inform the Tier 1
determination. EPA will respond to the submitter in writing and will
make its determination publicly available. A copy of the approach paper
has been placed in the docket for this policy (Docket ID number EPA-HQ-
OPPT-2007-1080).
In summary, EPA believes this approach to minimizing duplicative
testing, which parallels that used under FIFRA section 3(c)(2)(B),
provides all recipients of FFDCA section 408(p) test orders adequate
incentives to develop data jointly.
2. Promoting cost sharing and data compensation. As noted in Unit
IV.C.1., FFDCA section 408(p)(5)(B) directs the Agency to ``develop, as
appropriate, procedures for fair and equitable sharing of test costs.''
Informed by its experience under FIFRA, EPA sees this provision as
containing two related directives:
Promotion of the sharing of costs by companies that agree
to develop data jointly (``cost sharing'').
Payment of compensation to a data generator by a person
whose activity subsequent to the submission of the required data would
make such payment equitable (``data compensation'').
The first directive relates to sharing the cost of developing data
between parties on the market when a test order is issued. The second
directive relates to the payment by a person (who was not part of a
joint data development agreement) to those that originally generated
and submitted data, in exchange for relying on the results of their
previously submitted study. These mirror the data generation and data
compensation processes that have been followed for years under FIFRA,
and the Agency believes those processes are a good starting point for
dealing with these issues in the context of FFDCA section 408(p)(5)
orders. Consistent with FFDCA section 408(p)(5)(B), EPA intends, ``to
the extent practicable,'' to ``develop procedures for fair and
equitable sharing of test costs'' not only by persons in business when
the initial FFDCA section 408(p) test orders were issued, but also by
persons who enter the marketplace after the data are submitted.
As discussed in Unit IV.C.1., EPA has developed procedures to
implement FFDCA section 408(p) screening that minimize duplicative
testing; these measures also have the effect of substantially fostering
cost sharing among those who receive the initial test order. By using
an approach which parallels that used under FIFRA section 3(c)(2)(B),
any disincentives for the recipients of FFDCA section 408(p) test
orders to develop data jointly are addressed. EPA's experience with
FIFRA section 3(c)(2)(B) indicates that when multiple registrants
receive DCI notices to produce the same data on the same active
ingredient, they form consortia that work together to develop the
required data. If manufacturers and importers receive FFDCA section
408(p) test orders containing the provisions previously discussed, EPA
expects that they would behave in the same manner.
a. Compensable data under the EDSP. With respect to determining the
extent to which compensation for previously submitted studies is
warranted, the threshold issue is what EDSP data will be
``compensable.'' Given EPA's conclusion that FFDCA section 408(p)(5)(B)
does not give EPA the inherent authority to create new rights to
compensation, the threshold for what is ``compensable'' requires
consideration of existing statutory authority for compensation. To the
extent the data are otherwise covered by any provision of FFDCA or
FIFRA that requires a person to offer compensation for the right to
cite or rely on data submitted by another person in connection with a
pesticide regulatory matter, EPA must continue to enforce those
provisions.
FFDCA section 408(i) provides that data submitted under FFDCA
section 408 ``in support of a tolerance or an exemption from a
tolerance shall be entitled to . . . exclusive use and data
compensation to the same extent provided by section 3 of [FIFRA].'' The
Agency considers any data generated in response to requirements under
FFDCA section 408(p) on a pesticide chemical for which there is an
existing tolerance, tolerance exemption, or pending petition to
establish a tolerance or an exemption to be data submitted in support
of a tolerance or an exemption. In fact, FFDCA section
408(b)(2)(D)(viii) explicitly requires EPA to consider ``such
information as the Administrator may require on whether the pesticide
chemical may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen or other endocrine
effects,'' as part of its determination that a substance meets the
safety standard. (21 U.S.C. 346a(b)(2)(D)(viii)). Thus, EDSP data on
active and pesticide inert ingredients for which there is a tolerance
or tolerance exemption are compensable as outlined under FIFRA section
3(c)(1)(F).
Moreover, data establishing whether a pesticide chemical (either
active or inert) has the potential to interact with the endocrine
system would be relevant to a FIFRA registration decision. Under FIFRA,
EPA has a continuing duty to ensure that a pesticide meets the
registration standard; EPA must consider all available data relevant to
this determination. (See 7 U.S.C. 136a (bb) and 3(c)(5)). In the terms
of FIFRA section 3(c)(1)(F), such data ``support or maintain in effect
an existing registration.'' Thus, data generated in response to a FFDCA
section 408(p) test order are compensable as outlined in FIFRA section
3(c)(1)(F) if the data are submitted by a pesticide registrant because
FIFRA specifically grants those rights to registrants.
Given EPA's position that FFDCA section 408(p)(5)(B) does not give
EPA the authority to modify FIFRA data compensation rights, the fact
that EDSP data are potentially compensable under FIFRA raises questions
about the interplay between the two statutes. For example, unlike FIFRA
section 3(c)(2)(B), FFDCA section 408(p) does not give EPA the
authority to enforce an offer to pay compensation by suspending the
registration of a noncompliant company. Thus, unless and until such
data are used in support of a pesticide regulatory action under FIFRA,
if a recipient of a test order made an offer but then refused to pay
compensation or to participate in binding arbitration following the
data submitters acceptance of that offer, the data generator's only
recourse would be to seek any judicial remedies that may be available.
Consequently, rather than leave recipients with any ambiguity, EPA
intends to issue orders to registrants to conduct EDSP testing pursuant
to both FIFRA section 3(c)(2)(B) and FFDCA section 408(p).
In summary, most EDSP data are compensable under FIFRA or FFDCA
section 408(i). Data for active and pesticide inert ingredients that
have a tolerance or tolerance exemption or are the subject of a pending
petition are compensable regardless of what companies submit the data.
EDSP data generated from testing other active and inert ingredients are
also compensable as long as, in the case of a joint submission, at
least one of the submitters is a pesticide registrant or applicant.
While much EDSP data are compensable under FIFRA or FFDCA section
408(i), some EDSP data will be generated by chemical manufacturers and
importers of pesticide inert ingredients that have neither a tolerance
nor tolerance exemption and are not the subject of a pending tolerance
petition. (EPA refers to these substances as ``non-food use inerts.'')
Because such EDSP data could not be considered ``data
[[Page 17568]]
submitted in support of a tolerance or exemption,'' the data submitted
on such substances in response to a FFDCA section 408(p) test order are
not entitled to compensation under FFDCA section 408(i). Moreover,
since FIFRA section 3(c)(1)(F) establishes compensation rights only for
data submitted by an applicant or a registrant and inert ingredients do
not have separate or technical registrations, data submitted to EPA in
response to a FFDCA section 408(p) order by a person who is neither a
registrant nor an applicant are not compensable under FIFRA. However,
although data on a non-food use pesticide inert are not compensable
when submitted by a non-registrant pursuant to FFDCA section 408(p),
such data would become compensable when submitted jointly by an
applicant or registrant to support initial or continued registration of
a pesticide product containing that inert ingredient. That is, if the
submitters of data for a non-food use inert ingredient include a
product registrant, EPA intends to consider the data compensable.
In addition, EPA believes that the internal procedures it has
adopted effectively provide manufacturers and importers with the same
opportunity for cost sharing/compensation available to all other order
recipients.
Because EPA believes there are ways to make all EDSP data generated
on pesticide inert ingredients compensable, EPA must consider what
procedures to use to ensure persons who did not share in the cost of
testing, but who benefit from the existence of such data, actually pay
compensation. Under FIFRA section 3(c)(1)(F), companies that apply for
registrations of pesticide products after the data were submitted
either would have to offer to pay compensation for the right to cite
the data or would have to generate comparable data. Consequently, in
the case of active ingredients, everyone who benefits from the
existence of EDSP data on an active ingredient either shares the cost
of the testing as part of the joint data development under FIFRA
section 3(c)(2)(B) or offers to pay compensation to the original data
submitter under FIFRA section 3(c)(1)(F).
The same is not true for pesticide inert ingredients. There is no
mechanism under either FIFRA or FFDCA for directly requiring payment of
compensation by companies that start to manufacture or import a
pesticide inert ingredient after an original data submitter has
provided EDSP data on the pesticide inert ingredient. Such companies
are not subject to FIFRA data compensation obligations because they are
not registrants or applicants for registration. Nonetheless, EPA
believes that, by using its discretion under FFDCA section 408(p) to
issue test orders to new manufacturers or importers of a substance for
which EDSP data had previously been submitted, EPA can achieve
substantially the same ends.
FFDCA section 408(p)(5) provides that ``[t]he Administrator shall
issue an order to ``. . .a person who manufactures or imports a
substance for which testing is required under this subsection, to
conduct testing in accordance with the screening program . . . .''
Thus, under FFDCA section 408(p)(5), following the submission of
required EDSP data on the ingredient by manufacturers or importers who
were in the marketplace when the initial test orders were issued, EPA
generally intends to issue a test order to a manufacturer or importer
who begins to sell a pesticide inert ingredient after the test orders
requiring the data were issued. The Agency refers to these as ``catch-
up'' test orders. As with the initial FFDCA section 408(p) test order,
recipients could fulfill the testing requirement either by submitting
the results of a new study or by citing the data submitted by another
person or by agreeing not to sell into the pesticide market. In
furtherance of the goal of ``fair and equitable sharing of test
costs,'' the Agency would accept citation of existing data under the
same circumstances that it would accept the citation for recipients of
the original order--e.g., where the recipient of a catch-up test order
either had the original data submitter's permission or the recipient
had made an appropriate offer to pay compensation to the original data
submitter that also determined how disputes would be resolved.
Unless new manufacturers or importers requested pesticide
registrations, EPA cannot readily identify new entrants in the market.
EPA is largely relying on the manufacturers and importers who are part
of the data submitters' task force to inform the Agency about new
entrants to the market, at which time EPA intends to issue the FFDCA
section 408(p) ``catch-up'' test orders. Currently, EPA only intends to
send ``catch-up'' FFDCA section 408(p) test orders to subsequent
entrants into the marketplace within 15 years after the initial EDSP
test order(s) for the chemical is issued--a time frame matching the
period of compensability under FIFRA section 3(c)(1)(F).
b. Who provides compensation under this approach? Although the
procedures described would result in having all companies that
manufacture or import a pesticide inert ingredient share equitably in
the cost of generating required EDSP data, FIFRA imposes additional
compensation requirements on the customers of such companies who
purchase the pesticide inert ingredients for use in formulating their
registered pesticides. Specifically, FIFRA section 3(c)(1)(F) requires
an applicant for a new or amended registration to offer to pay
compensation to the original submitter of EDSP data if the applicant's
product contains an ingredient (active or inert) for which EDSP data
have been submitted.
For all compensable data, the Agency interprets the formulator's
exemption to be applicable. The formulator's exemption under FIFRA
section 3(c)(2)(D) would only be applicable to EDSP data generated on
non-food use pesticide inerts if the data are submitted jointly by a
registrant or applicant for registration. However, EPA believes that it
can effectively achieve the same ends through the internal procedures
it adopts, and through its discretion to selectively issue FFDCA
section 408(p) test orders only to importers and manufacturers of such
pesticide inert ingredients. The policy rationale underlying FIFRA's
formulator's exemption is equally applicable in the case of non-food
use pesticide inerts. Specifically, Congress believed that, so long as
the requirements apply equally to manufacturers of a particular
ingredient, the price of their product should also reflect any data
development costs. Accordingly, requiring compensation of product
purchasers would have the effect of requiring purchasers to pay data
development costs twice--once as a condition of satisfying a FFDCA
section 408(p) test order, and thereafter as part of the price of the
pesticide inert ingredients they purchase to make their products. (See
49 FR 30892, August 1, 1984). As a result, EPA has adopted the
following procedures to determine whether the end-use formulators have
met their obligations to submit EDSP screening data.
c. Determining whether compensation obligations have been met.
Currently, EPA maintains a list of all data on active ingredients that
would support a technical registration along with contact information
for the owners of the data. This is the Data Submitters List. Product
applicants must identify the chemicals in their product and, in the
case of the active ingredient(s), they must identify the source of the
ingredient(s). If the source of the active ingredient is a registered
product that is labeled for the same (or more) uses as the applicant's
product, the applicant is entitled to claim the formulators' exemption
from
[[Page 17569]]
all data requirements relating to the purchased product and need not
submit or cite such data. If the applicant is not eligible for the
formulators' exemption, an applicant must submit or cite required data
(for a technical product registration, the required data are typically
data submitted on the active ingredients to support a technical
registration). The citation is accompanied by a certification that an
offer to pay was made to the owners of the data. FIFRA requires that an
applicant/registrant agree to binding arbitration to resolve disputes
regarding compensation. If the applicant or registrant fails to fulfill
either the terms of a compensation agreement or an arbitrator's award,
the owner of the data may petition the Agency to cancel the
registration. These procedures are also applicable to EDSP data that
are subject to FFDCA section 408(i).
The approach outlined here to address compensation for EDSP data on
pesticide inert ingredients is consistent with those adopted
generically for all food use pesticide inert data, as there is no
reason for creating separate procedures for EDSP pesticide inert data
and all other food use pesticide inert data.
First, for each pesticide inert ingredient on which EPA receives
EDSP data, EPA intends to identify the data submitter on a ``Pesticide
Inert Ingredients Data Submitters & Suppliers List'' (PIIDSSL). This
list identifies every company that submits the required EDSP data
(original data submitters). The PIIDSSL also contains the names of
every company that fulfilled its obligation under a FFDCA section
408(p) test order by offering to share the cost of testing with other
data developers, as well as any other company that the original data
submitter identifies as entitled to serve as a source of the pesticide
inert ingredient from whom an applicant or registrant may obtain the
pesticide inert without making an offer to compensate the original data
submitter (``approved inert suppliers'' or ``approved sources'').
Second, under FIFRA section 3(c)(1)(F), the action of submitting an
application of a pesticide containing the pesticide inert ingredient
will trigger the obligation for the applicant to provide compensable
EDSP data. The applicant may satisfy this requirement by submitting new
data or citing existing data. In most cases, however, EPA expects an
applicant to comply by claiming that the pesticide inert ingredient
comes from an ``approved source'' and therefore that the principles of
the formulator's exemption apply. To fulfill the obligation in this
manner, EPA intends to require a pesticide applicant to identify the
source of pesticide inert ingredients for which there are compensable
EDSP data. Then, EPA would agree that the applicant had adequately
complied with FIFRA section 3(c)(1)(F) and FFDCA section 408(p)(3)'s
requirements if the person identified as the source for the pesticide
inert ingredient appears on the PIIDSSL as either an original data
submitter or an approved source for that pesticide inert ingredient.
Third, on a case-by-case basis, EPA may require current registrants
to identify the source of a pesticide inert ingredient on which EDSP
data have been submitted. If the registrant of a pesticide product
identifies a source for the pesticide inert ingredient that is not on
the PIIDSSL, the registrant would have the choice of changing its
supplier of the pesticide inert ingredient to an approved source on the
PIIDSSL list. (Note: EPA also intends to revise the guidance presented
in PR Notice 98-10 regarding notifications to provide that a registrant
may not change the source of a pesticide inert ingredient on the
PIIDSSL in its formulation by notification. Such a change must be made
through an application for amended registration.) Should the registrant
not choose to obtain the pesticide inert ingredient from an approved
source, EPA generally intends to issue an order to the registrant,
requiring the registrant either to generate the EDSP test data or offer
to pay compensation to the original data submitter on the PIIDSSL.
D. What Procedures Apply for Handling CBI?
FFDCA section 408(p)(5)(B) also requires that EPA, to the extent
practicable, develop, as necessary, procedures for the handling of CBI.
Many of the same considerations laid out in Unit IV.C. are relevant to
EPA's implementation of this directive. EPA has therefore adopted a
consistent approach with respect to the handling of CBI.
As with the directives to develop procedures for sharing test costs
and minimizing duplicative testing, EPA does not think that FFDCA
section 408(p)(5)(B) provides the authority for the Agency to either
create new rights or to modify existing rights to confidentiality.
Rather, EPA believes that this provision directs the Agency to create
procedures that operate within the existing confines of FFDCA section
408(i), FIFRA section 10, the Freedom of Information Act (FOIA), and
the Trade Secrets Act.
As explained in Unit IV.C., because EPA considers much of the data
submitted in response to FFDCA section 408(p) orders to be submitted in
support of a tolerance or tolerance exemption, such submissions are
entitled to confidential treatment to the same extent as under FIFRA
section 10, pursuant to FFDCA section 408(i). In addition, CBI
submitted by pesticide registrants in response to a FFDCA section
408(p) test order is considered as part of the registration process,
and is therefore considered to be submitted in support of a
registration. As such, that information is directly subject to FIFRA
section 10. However covered, information subject to FIFRA section 10 is
provided certain protections that go beyond those authorized by FOIA.
For example, FIFRA section 10(g) generally prohibits EPA from releasing
information submitted by a registrant under FIFRA to a foreign or
multinational pesticide producer, and requires the Agency to obtain an
affirmation from all persons seeking access to such information that
they will not disclose the information to a foreign or multinational
producer. FFDCA section 408(i) extends the protection available under
FIFRA section 10 for data submitted in support of a tolerance or
tolerance exemption.
All other CBI submitted in response to a FFDCA section 408(p) test
order (i.e., data not in support of a registration or tolerance/
tolerance exemption) is only protected by the provisions of the Trade
Secrets Act which incorporates the confidentiality standard in FOIA
Exemption 4. FOIA requires agencies to make information available to
the public upon request, except for information that is ``specifically
made confidential by other statutes'' or data that are ``trade secrets
and commercial or financial information obtained from a person and is
privileged or confidential.'' (5 U.S.C. 552(b)(4)). Note that
substantive criteria must be met to claim confidentiality of business
information, as specified in 40 CFR 2.208.
As with EPA's approach for data compensation, EPA considers that
data submitted jointly with a registrant, or as part of a consortium in
which pesticide registrants participate, to be data submitted in
support of a tolerance/tolerance exemption or registration, and
therefore entitled to protection under FIFRA section 10. However, if a
non-registrant chooses not to partner with a registrant, such data is
only subject to the protections available under FOIA and the Trade
Secrets Act.
[[Page 17570]]
E. Who Would Receive FFDCA Section 408(p) Test Orders Under the EDSP
and How Would They Be Notified?
Under FFDCA section 408(p)(5)(A), EPA ``shall issue'' EDSP test
orders ``to a registrant of a substance for which testing is required .
. . or to a person who manufactures or imports a substance for which
testing is required.'' EPA has identified the following categories of
potential test order recipients:
Technical registrants (basic manufacturers of pesticide
active ingredients). Entities who manufacture or import an active
ingredient and hold an active EPA registration (technical registrants
in most cases). Usually a product with technical registration is used
in the formulation of other pesticide products. However, EPA also uses
this term in this policy statement to include registrants who use an
integrated system, that is, those who produce their own active
ingredient, as well as those who use an unregistered technical active
ingredient. In the interest of simplifying this document, the phrase
``technical registrant'' will be used to refer to:
(1) Registrants of a technical grade of active ingredient; and
(2) Registrants whose products are produced using an integrated
system, as defined in 40 CFR 158.153(g), (which includes registrants
who use an unregistered technical active ingredient to manufacture
their pesticide product).
End-use registrants (formulators/customers). Registrants
whose products are formulated and sold for end use; such product
generally contain both an active ingredient as well as pesticide inert
ingredients. The registrant does not necessarily manufacture or import
the active pesticide ingredient or inert.
Manufacturers/importers. Entities who manufacture or
import a pesticide inert ingredient that do not necessarily have to
hold an EPA registration for the sale of pesticide products. This also
includes those manufacturers of pesticide products that are intended
solely for export, so long as another company has a U.S. pesticide
registration for the chemical, or an import tolerance exists for that
chemical.
1. Pesticide active ingredients. EPA generally intends to send test
orders issued pursuant to FFDCA section 408(p) and FIFRA section
3(c)(2)(B) to technical registrants of the pesticide active ingredient.
The Agency can easily identify the technical registrants of pesticide
active ingredients. As previously noted, a technical registrant holds a
registration for a specific active ingredient that it then formulates
into end-use (or retail) products or that its customers purchase for
formulation into end-use products. Typically much of the safety data
EPA requires is conducted on the technical grade active ingredient,
rather than on the end-use product. (See generally, 40 CFR part 158).
Consequently, the ``technical registrants,'' who are typically not
considered to be a small business, have historically been responsible
for generating most of the data that support pesticide registrations.
Registrants of end-use products generally rely on the data generated by
the technical registrants in accordance with the ``formulator's
exemption'' in FIFRA section 3(c)(2)(D).
Some active ingredients are ``commodity chemicals,'' that is, they
may be used both in non-pesticidal products, such as drugs or cleaning
products, and as active ingredients in pesticide products. When a
company produces such a commodity chemical and that company does not
sell or distribute the chemical as a pesticide within the meaning of
FIFRA section 2(u) and 40 CFR 152.15, FIFRA does not require
registration of the chemical until it is sold or distributed in a
product that is intended for a pesticidal purpose. However, FFDCA
section 408(p)(5) specifies that EPA is to send test orders to
manufacturers and importers of ``a substance for which testing is
required under this subsection,'' and does not limit testing
requirements only to manufacturers/importers of a pesticide chemical.
Once EPA issues a test order for a pesticide chemical, a person who
manufactures that chemical, even if not for use as a pesticide, is
clearly manufacturing a substance for which testing is required, and
consequently, is potentially subject to EPA's authority under the plain
language of FFDCA section 408(p)(5).
Since EPA's goal is to follow as closely as feasible its existing
practices for data generation under FIFRA, EPA generally intends to
issue FFDCA section 408(p) test orders initially only to current
pesticide registrants (and if there are any, only to technical
registrants). Such orders would be issued under the authority of both
FFDCA section 408(p) and FIFRA section 3(c)(2)(B). The Agency expects
to issue ``catch-up'' test orders to any entity selling a commodity
chemical into the pesticide market. This will occur when a commodity
chemical company is discovered to be selling into the pesticide market
for 15 years subsequent to the initial issuance of the testing orders.
2. Pesticide inert ingredients. EPA generally intends to send test
orders issued pursuant to FFDCA section 408(p) to current manufacturers
and importers; and ``catch-up'' FFDCA section 408(p) test orders to
manufacturers and importers who subsequently enter the marketplace for
15 years after the initial test order(s) for the chemical is issued.
For pesticide inert ingredients, manufacturers/importers include any
company that manufactures or imports the chemical regardless of whether
it is a registrant and regardless of whether it directly sells the
chemical for use as a pesticide inert.
For the purposes of discussion, EPA identified two subclasses of
pesticide inerts:
Food use pesticide inerts, i.e., pesticide inert
ingredients with an existing or pending tolerance or tolerance
exemption.
Non-food use pesticide inerts.
a. Food-use pesticide inerts. If a pesticide inert ingredient has
an existing or pending tolerance or tolerance exemption, data
compensation and data confidentiality protection are available pursuant
to FFDCA section 408(i). For this class of pesticide inert ingredients,
EPA generally intends to issue FFDCA section 408(p) test orders to
manufacturers and importers.
b. Non-food use pesticide inerts. EPA generally intends to send the
FFDCA section 408(p) test orders only to manufacturers/importers of the
substance used as a non-food use pesticide inert ingredient. Note that
EDSP data submitted on non-food use pesticide inerts are not covered by
the data compensation and data confidentiality provisions of FFDCA
section 408(i) or by FIFRA, unless the data are submitted by a
registrant or a consortium that includes at least one registrant.
Therefore, although EPA does not currently intend to send initial test
orders to registrants, EPA encourages non-registrant recipients who
submit data to partner with a registrant, so they will receive added
protections under FIFRA for proprietary information or compensation
from applicants who use the pesticide inert ingredient to formulate
their pesticide products. Bear in mind, however, that even where
FIFRA's compensation provisions do not apply, EPA expects that the
Agency's procedures (e.g., whereby companies entering the market after
submission of the EDSP data would receive ``catch-up'' FFDCA section
408(p) test orders) would lead to the manufacturers and importers
subject to the initial FFDCA section 408(p) test
[[Page 17571]]
orders receiving offers to share test costs equitably.
3. How would EPA identify order recipients? For FFDCA section
408(p) test orders involving pesticide active ingredients, the Agency
intends to rely on the Office of Pesticide Programs' (OPP's) Office of
Pesticide Programs Information Network (OPPIN). OPPIN is an internal
OPP database for query, input and tracking of pesticide products,
ingredients, studies, regulatory decisions and other information. The
OPPIN system is typically used to produce study bibliographies or lists
of registered products. EPA intends to use OPPIN to identify
registrants of the pesticide active ingredients identified for initial
screening under the EDSP.
For FFDCA section 408(p) test orders involving pesticide inerts,
the Agency intends to use OPPIN (where applicable), information from
the TSCA Inventory Update Rule (IUR), and rely on other databases to
identify appropriate manufacturers/importers and end-use registrants.
These other databases may include publicly available sources like Dun
and Bradstreet, online marketing material, etc.
EPA intends to make public the list of recipients of FFDCA section
408(p) test orders and DCI notices and invite the public to identify
additional persons who should have received the FFDCA section 408(p)
test order. Commenters could either identify themselves or another
person as additional candidates (with proper substantiation) for
receipt of a FFDCA section 408(p) test order. If the identity of a
company subject to the test order is claimed as CBI, EPA intends to
offer the company an opportunity to identify an agent who would act on
their behalf in all matters relating to the EDSP program. For any
company that chooses to designate an agent, the Agency intends to make
the name of the agent (instead of the company) public by including it
on the list of recipients of FFDCA section 408(p) test orders and DCI
notices. If the identity of a company subject to the test order is
claimed as CBI, and yet the company does not name an agent, that
company's ability to obtain data compensation from other parties (or
rely on compensable data submitted by other parties) would likely be
affected. EPA generally intends to publish the list of order recipients
in the Federal Register and post it on the Agency's website. EPA
intends to update the list with subsequent publication(s) and
posting(s) as appropriate. For example, the Agency intends to post the
status of the testing orders, including the recipient's response, on
the Agency website so that both order recipients and the public can
check on the status of responses to the orders. This public listing is
intended to also facilitate the formation of consortia to develop data
jointly since recipients would know all other entities required to
generate the same data.
4. How would EPA notify order recipients? Order recipients would be
notified through their direct receipt of a FFDCA section 408(p) test
order via first-class mail, with return receipt. Each order recipient
would receive an ``EDSP Order Packet'' that EPA expects will contain
the signed order, a list of other order recipients for that chemical,
and the Initial Response Form, pre-populated with the recipient-
specific information and due dates for complying with the order.
F. Potential Responses to a Test Order
In general, EPA expects that the orders would direct recipients to
utilize the following procedures to respond either to an initial FFDCA
section 408(p) test order or to a ``catch-up'' test order issued to a
person who began to manufacture or import a pesticide inert ingredient
for 15 years after the initial test order(s) for the chemical is
issued. These options are also appropriate for responding to test
orders issued jointly under the authority of FFDCA section 408(p) and
FIFRA section 3(c)(2)(B).
1. Initial response. Each recipient would be directed to provide an
initial response to EPA within 90 days of the issuance of the order.
This initial response is intended to be used to report the recipient's
commitment to act in response to the test order in one of several ways
for each assay specified in the order, and may indicate a different
response commitment for each assay.
To facilitate completion of this initial response within the 90
days, EPA has created two simple Initial Response Forms that EPA
intends to pre-populate with basic information about the chemical and
recipient to connect it to the specific order. One form is for use by
the Individual Order recipient and the other is for use when a
Consortium provides their group's response. EPA intends to include both
of the Initial Response Forms in the EDSP Order Packet that is sent to
the recipients. Please note that in calculating the due date for the
Initial Response Form, the Agency intends to include an additional 10
calendar days to account for the Agency processing of the final order
package for delivery to the Post Office.
An Order recipient may elect any of these options for one or more
of the assays in the Order, and is not limited to electing a single
response for all assays, nor are they required to elect different
options for each assay. For simplicity, however, the Response Form is
structured so that recipients indicate their responses on an assay-by-
assay basis--even if the response is the same for more than one of the
assays.
Any recipient who did not fulfill the commitments made in its
initial response would be subject to enforcement action for its failure
to comply with the FFDCA section 408(p) order, in accordance with
section 408(p)(5)(D). Having failed to perform the actions necessary
for this response option, the recipient would be obliged to immediately
comply with the order--i.e., to provide the data, within the time frame
that had originally been required by the order. In addition, the
recipient would potentially be subject to penalties, pursuant to 18
U.S.C. 1001, for willfully making any false or misleading statements to
the Federal government.
The recipient of a test order has several potential initial
responses from which it can choose. The 90-day initial response options
include the following.
a. Recipient indicates that it intends to generate new data.
Recipients would choose this option to indicate that it agrees to
individually generate new data for the test(s) specified in the Tier 1
Order. In the case of data pertaining to a pesticide inert ingredient
for which there is no tolerance or exemption (a ``non-food use'' inert
ingredient), the recipient may negotiate an agreement to have a
registrant of a product containing the pesticide inert ingredient
submit the data after it is generated so that the data qualify for
compensation under FIFRA--the data generator and the registrant could
work out among themselves the details of such an agreement.
b. Recipient indicates that it is submitting or citing existing
data. The recipient would choose this option to indicate that it is
submitting or citing existing data (including citing data previously
submitted to the Agency) that they believe is relevant to one or more
of the requests in the test order. The recipient's initial response
would include either the data or a reference to the data for each assay
specified in the order. In submitting or citing existing data, the
order recipient or other party should follow, as appropriate, relevant
format guidelines described in Unit IV.F.4. and provide an explanation
of the relevance of the data to the order, including, where
appropriate, a cogent and complete rationale for why it believes the
information is or is not sufficient to satisfy part or all of the Tier
1 Order.
[[Page 17572]]
Data compensation procedures may apply to data previously submitted
to the Agency. If the data cited or submitted are from a study that was
not conducted exactly as specified in the protocols referenced in the
test order or in accordance with accepted scientific methodology or
protocol, including but not limited to those presented in EPA's
harmonized test guideline compendium (see http://www.epa.gov/oppts and
select ``Test Methods & Guidelines'' on the left), the recipient would
also identify the deviations from the applicable protocol(s), along
with an explanation for the deviations, including an explanation as to
why, notwithstanding the deviations, the protocol used for developing
the cited or submitted data should still be considered as providing an
accepted scientific methodology or protocol, and any other information
relevant to a decision to accept the data as satisfaction of the Order.
EPA would review any existing relevant information submitted or
cited (including other scientifically relevant information) to
determine whether the information is acceptable (i.e., the study was
not rejected by the Agency for any reason related to completeness or
quality) and satisfies the Order. Decisions about whether the
information satisfies part or all of the Tier 1 Order will be based on
the weight-of-evidence from all relevant information available. The
Agency would notify the recipient in writing of its determination.
If the Agency determines that the information cited or submitted as
part of the initial response received from an Order recipient can be
used to satisfy the Tier 1 Order, which will be based on the weight-of-
evidence from all relevant information available to the Agency, the
Initial Response Form is the only response required.
If, however, EPA determines that the information cited or submitted
as part of the initial response is insufficient to satisfy the Tier 1
Order, although it may satisfy part of the Order, the recipient would
still need to satisfy the remainder of the Order.
As indicated previously, EPA intends to use a weight-of-evidence
basis, taking into account data from the Tier 1 assays and any other
scientifically relevant information available, to determine whether the
chemical has the potential to interact with the endocrine system.
Chemicals that go through Tier 1 screening and are found to have the
potential to interact with the estrogen, androgen, or thyroid hormone
systems will proceed to the next stage of the EDSP where EPA will
determine which, if any, of the Tier 2 tests are necessary based on the
available data. Tier 2 testing is designed to identify any adverse
endocrine-related effects caused by the substance, and establish a
quantitative relationship between the dose and that endocrine effect.
EPA is not currently able to provide definitive examples of the
specific circumstances in which a chemical would be able to go directly
to Tier 2 testing; however, if an Order recipient chooses to make such
a request, EPA will consider it, along with any justification provided.
In general, it may in some cases be possible to determine that a
particular chemical has the potential to interact with the endocrine
system and therefore could proceed to Tier 2 even if Tier 1 data are
limited. However, if only some of the Tier 1 data are available, there
may not be sufficient information to determine that some of the Tier 2
data are not necessary. These determinations will be made in a weight-
of-evidence judgment on a case-by-case basis and made publicly
available for consideration by others with the same or similar
circumstances.
c. Recipient indicates that it intends to enter (or offer to enter)
into an agreement to form a consortium to provide the data. The
recipient would choose this option to indicate that it intends to enter
(or has offered to enter) an agreement with other order recipients to
form a consortium or task force to comply with the test order. Each
consortium participant or potential participant is expected to submit
an Initial Response Form within 90 days. The lead for the consortium is
expected to submit documentation confirming the formation of the
consortium or task force within 150 calendar days of issuance of the
Order/DCI, or as part of their initial response. Such documentation
would include the contact information for the primary consortia
contact, a list of participants, and the intended consortia action/
response for each assay. EPA's typical practice has been that, if the
consortia fails to satisfy the order, all parties would be held to have
violated the test order.
Alternatively, recipients may provide EPA with documentation that
they have made an offer to join the consortium or commence negotiations
regarding the amount and terms of paying a reasonable share of the cost
of testing, and have included an offer to submit to a neutral third
party with authority to bind the parties to resolve any dispute over
the recipient's share of the test costs, (e.g., through binding
arbitration). Note: EPA's typical practice has been that, if the
required data are not generated by the person(s) to whom the offer is
made, all parties, including those that have made offers to pay or
otherwise joined the consortium, would be held to have violated the
test order.
d. Recipient claims that they are not subject to the test order.
The recipient would choose this option to indicate that they are not
subject to the order because:
(i) In the case of a test order that requires data on an active
ingredient, the recipient is not a pesticide registrant, or
(ii) In the case of an initial test order that requires data on a
pesticide inert ingredient, the recipient does not currently
manufacture or import the chemical.
(iii) In the case of a ``catch-up'' order, the recipient obtains
the chemical solely from persons who are either (1) the original data
submitter; (2) a person who has complied with a test order by offering
compensation; or (3) a person who is otherwise an approved source
(i.e., is listed on the PIIDSSL) for that inert. An explanation of the
basis for the claim, along with appropriate information to substantiate
that claim, is required to allow EPA to evaluate the claim.
The recipient's initial response would include an explanation and
documentation supporting their claim. If EPA verifies your claim of not
being subject to the order, the Initial Response Form is the only
response you are required to complete to satisfy the order. If,
however, EPA cannot verify your claim, you must still comply with the
order and the deadline(s) for responding remain.
e. Recipient indicates that it intends to voluntarily cancel their
registration(s). Registrants may request voluntary cancellation of
their product's pesticide registration(s) pursuant to FIFRA section
6(f). Such a request must be submitted within 90 days of the issuance
of the order. Doing so would initiate the existing procedures for a
voluntary cancellation (see 40 CFR 152.99). Under those procedures, the
registrant may either adopt the standard provisions for sale or use of
existing stocks of their pesticide, or may propose an alternative
procedure. If the recipient chooses this option, the Initial Response
Form is the only response required to satisfy the Order as long as the
Registrant completes the voluntary cancellation procedures. When their
product's pesticide registration(s) is canceled, the recipient would be
considered to have satisfied the order.
f. Recipient indicates that it intends to reformulate their
product(s) to exclude the chemical from the formulation. In
[[Page 17573]]
place of submitting the data required in this order, a registrant may
submit an application to amend the formulation of its product by
removing as an ingredient of their product the chemical that is the
subject of the order. For example, this may occur in the case of a
pesticide inert ingredient if EPA issues orders to end-use registrants.
Submitting such an application would initiate the existing procedures
for reformulation, and such a request must be submitted within 90 days
of the issuance of the order. If the recipient chooses this option, the
Initial Response Form is the only response required to satisfy the
order as long as the registrant completes the reformulation procedures.
When their product's formulation has been changed, the recipient would
be considered to have satisfied the order.
g. Recipient claims a formulator's exemption. A product registrant
who receives an order to test a chemical and who purchases the chemical
from another recipient that has agreed to generate the data may be
eligible for a formulator's exemption. The recipient's initial response
would include an explanation and documentation supporting their claim.
EPA will confirm such claims of eligibility. A response asserting the
formulator's exemption would no longer be considered an appropriate
response to a test order if the supplier of the chemical fails to
comply with the test order (i.e., it fails to submit the data either
individually or jointly with other recipients or it fails to comply
with the terms of a compensation agreement or the binding decision of a
neutral third party regarding the terms of compensation). If EPA
confirms the eligibility claim, the Initial Response Form is the only
response required to satisfy this order. If, however, EPA determines
that the order recipient is not eligible, the recipient must comply
with the order.
h. Recipient indicates that it has or is in the process of
discontinuing the manufacture or import of the chemical. The recipient
of an order for a pesticide inert ingredient (i.e., manufacturer/
importer) would choose this option to indicate that they are in the
process of discontinuing the manufacture or import of the chemical. The
recipient's initial response would include an explanation and
documentation supporting their claim. EPA intends to verify such a
claim. If EPA confirms the claim, the Initial Response Form is the only
response required to satisfy this order. If, however, EPA determines
that the claim is false, the recipient must comply with the order.
i. Recipient indicates that it does not and will not sell the
chemical for use in pesticide products. The recipient of an order for a
pesticide inert ingredient (i.e., manufacturer/importer) would choose
this option to indicate that they do not currently or agree to no
longer sell their chemical for use in the pesticide market. To elect
this option, the order recipient would indicate, as part of its initial
response, that they commit to discontinue, on or before a date 6 months
after the issuance of the test order, all sale and distribution of the
pesticide inert ingredient that is the subject of the test order to any
person who the recipient knows or reasonably should know, intends to
use the substance in the formulation of a pesticide product. The order
recipient would also indicate that it will include in all contracts for
sale or distribution of the material a provision that contractually
prohibits the purchaser from using the substance in the formulation of
a pesticide product. As part of its initial response, the order
recipient would be asked to provide a copy of the contract provision
and a certification to include this contractual provision in any
contracts entered into on or after a date 6 months after the issuance
of the test order.
j. Request an exemption under FFDCA section 408(p)(4). EPA
recognizes that FFDCA section 408(p)(4) provides that ``the
Administrator may, by order, exempt from the requirements of this
section a biologic substance or other substance if the Administrator
determines that the substance is anticipated not to produce any effect
in humans similar to an effect produced by a naturally occurring
estrogen.'' In 1998, the Agency assessed the need to develop a specific
list of substances to be exempted from EDSP testing or an exemption
process for those substances that might not be anticipated to produce
endocrine effects in humans (See Unit VI.L. of the December 1998 notice
at 63 FR 71542). In the 1998 FR notice, EPA also provided several
examples of substances that might possibly be exempted. As the EDSP has
evolved and more endocrine research has been conducted, it has become
evident that, at this time, development of criteria to exempt certain
substances or to otherwise identify any pre-determined or blanket
exemptions from endocrine disruptor testing is premature.
For the initial screening, EPA is not aware of sufficient data that
would allow the Agency to confidently determine that a chemical meets
the statutory standard for an exemption--i.e., that it is not
anticipated to interact with the endocrine system. Although a
relatively broad range of toxicity data are available for pesticide
active ingredients regulated under FIFRA, in most cases EPA has not yet
established how the available data might be confidently used to predict
the endocrine disruption potentials of these chemicals. This may be due
to the non-specific nature of an effect or effects observed, questions
related to whether the mode of action in producing a given effect or
effects is or are endocrine system-mediated in whole or in part, or the
lack of relevant data to make a judgment altogether.
However, if an order recipient believes that this showing can be
made for its chemical, the Agency would consider requests to issue such
an exemption order on a case-by-case or chemical-by-chemical basis in
response to individual submissions. In order for the Agency to make the
necessary statutory finding to issue the exemption, the request would
need to provide any hazard-related information that you believe would
allow EPA to determine that your chemical is anticipated to not be an
endocrine disruptor, i.e., is not anticipated ``to produce any effect
in humans similar to an effect produced by a naturally occurring
estrogen.''
k. Other initial responses--(i) Pre-enforcement challenges to a
test order. A recipient may wish to challenge the test order. Unit
IV.H., describes the informal process by which a recipient may raise,
and EPA may review, objections to the issuance of a test order or to
specific provisions in the order. In order for EPA to be able to
respond to the objections in a timely manner, the recipient would need
to state with particularity the scope and basis of the objection,
providing sufficient detail to allow the Agency to evaluate the
objection. For further information refer to Units IV.H. and IV.I.
(ii) Additional EDSP screening is unnecessary because the chemical
is an endocrine disruptor or was used as a ``positive control'' in the
EDSP validation effort. If an Order recipient chooses to ask EPA to
reconsider some or all of the testing specified in the Tier 1 Order,
EPA would review the request, along with the appropriate information
supporting the claim that additional EDSP screening of the chemical is
unnecessary because the chemical is an endocrine disruptor or was used
as a ``positive control'' in the EDSP validation effort, on a case-by-
case basis. Based on the information currently available, EPA generally
expects that if the chemical was used by EPA as a ``positive control''
to validate one or more of the screening assays, only the data
submitted related to those assays
[[Page 17574]]
for which the chemical was used to complete the testing as part of the
validation effort would be sufficient to satisfy the Tier 1 Order.
As discussed in detail in Unit IV.F.1.b., under one of the response
options provided in the Tier 1 Order, a recipient may choose to cite or
submit existing data they believe can be used to satisfy part or all of
the Tier 1 Order. Existing data may be of several types. An example may
be an in vitro assay for transcriptional activation that is conducted
with a different cell line and by a different protocol. But more
generally, existing data may be other scientifically relevant
information. Scientifically relevant information can include data from
studies other than the EDSP Tier 1 assays, e.g., studies conducted to
satisfy a 40 CFR part 158 or part 161 data requirement, data from other
studies conducted to address an identified issue, or data from studies
found in the scientific literature. In addition to the Tier 1 Order
recipient, anyone can submit other scientifically relevant information.
To allow EPA to review the submission of other scientifically relevant
information in a timely fashion, the submitter of the information
should consider providing a scientifically sound rationale that
explains how the submitted or cited data provides the information
needed to satisfy part or all of the Tier 1 Order and/or otherwise
inform the Agency's Tier 1 determination.
2. Generate the data specified in the Tier 1 Order. As indicated in
the Initial Response Form, the recipient's next step will vary
depending upon their initial response. The process diagram in the
docket outlines the overall process with the various response options.
In general, assuming that the order recipient indicated that they will
generate the data individually or as part of a consortium, the next
step in responding to the order would be the generation of the data as
specified.
The tests would generally be conducted using the test protocols
cited in the order because FFDCA requires that the test method be
validated. If, however, an order recipient believes a deviation from
the required protocol is needed, they would first consult with the
Agency before deviating from the test protocol. All requests would be
submitted with a clear rationale to allow the Agency to evaluate the
request in a timely manner. EPA intends to review all protocol
variations and send a written response to the specific order recipient
in a timely fashion.
In addition, order recipients generating data must adhere to the
good laboratory practice (GLP) standards described in 40 CFR part 160
when conducting studies in response to a FFDCA section 408(p) test
order.
3. Submit a progress report. Unless EPA has notified the recipient
that they have satisfied the order, EPA generally intends to ask each
order recipient to submit a progress report to EPA 12 months after
issuance of the order. Each progress report would provide a brief
description of the status of the recipients planned activities for each
assay, and, if applicable, a description of any problems encountered or
expected difficulties in meeting the schedule for complying with the
order.
4. Submit the data specified in the test order. Assuming that the
order recipient indicated that they would generate the data
individually or as part of a consortium, the next step in responding to
the order would be the submission of the data as specified. The Agency
generally intends for the order to include a final submission due date
of 24 months after the issuance of the order. In establishing this
timeframe, the Agency considered:
(a) The timeframes set for the initial response and consortia
documentation;
(b) The duration of each assay in terms of estimated timeframes for
planning, performing the tests and documenting results; and
(c) The estimated timeframes for preparing and completing the final
data submission to EPA.
EPA believes that having a single due date allows the order recipients
to efficiently plan the activities necessary for generating and
submitting the data, including entering into joint agreements and
sequencing the laboratory activities as appropriate. Although EPA
intends to establish a single due date, if the order recipient or
consortia choose to submit the results from each assay individually,
the order would be satisfied when the Agency determines the results
submitted satisfy the order.
The Agency intends to use the same submission procedures as those
that are currently used for submitting other data in support of a
pesticide registration, with only a few modifications. Once the data
are generated, the recipient would prepare a submission package for
transmittal to EPA. EPA intends for the orders to include requirements
on how the data would be formatted or presented for submission to EPA.
In general, EPA expects the orders to include the following
instructions.
a. Format for data submission. As part of a cooperative NAFTA
project, EPA and the Canadian Pest Management Regulatory Agency (PMRA)
developed standard data evaluation formats, or templates. The templates
have been in use by these agencies since 2002 for writing their data
evaluation records (DERs) of studies submitted under FIFRA and FFDCA to
EPA and the Canadian data codes (DACOs). Although such templates do not
currently reflect the assays being considered for the EDSP Tier 1
battery, the Agency intends to review and, as necessary, develop new or
revised templates before the deadlines for submission of the data under
the EDSP.
The DER that the agencies prepare contains a study profile
documenting basic study information such as materials, methods,
results, applicant's conclusions and the evaluator's conclusions. The
templates provide pesticide registrants and the public an opportunity
to gain a better understanding of the regulatory science review and
decision-making process. The agencies encourage registrants to include
study profiles based on these templates in their study documents for
all pesticide types. These templates describe the layout and scope of
information that would be contained within a study profile and can
serve as guides for preparation of study documents. Use of the
templates improves the likelihood of a successful submission, since the
information necessary for an efficient agency review is outlined.
Additional details about these templates are available at: http://
www.epa.gov/pesticides/regulating/studyprofile_templates/.
In addition, Pesticide Registration (PR) Notice 86-5, entitled
Standard Format for Data Submitted Under the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the
Federal Food, Drug, and Cosmetic Act (FFDCA), describes how to organize
and format submittals of data supporting a pesticide registration
(http://www.epa.gov/PR_Notices/pr86-5.html). The Agency has begun the
process of updating the guidance in PR Notice 86-5 to further clarify
the data submission process for pesticide-related submissions and
intends to provide the public with an opportunity to comment on the
proposed revisions to PR Notice 86-5 consistent with the procedures
described in PR Notice 2003-3, entitled Procedural Guidance for EPA's
Office of Pesticide Programs Procedures Concerning the Development,
Modification, and Implementation of Policy Guidance Documents; (http://
www.epa.gov/PR_Notices/pr2003-3.pdf).
The Agency also intends to encourage FFDCA section 408(p) test
order recipients to submit completed study profiles and supporting data
in an
[[Page 17575]]
electronic format whether submitting one or several studies. OPP has
established Adobe Portable Document Format (PDF) as the standard file
format for the electronic submission of required studies, using compact
disks as the transport medium. In addition, OPP recently announced an
e-Submission initiative to help EPA move toward a more paperless
environment. The information exchange from industry to EPA is based on
a harmonized eXtensible Markup Language (XML) schema used by Canada's
PMRA, which has been adapted by EPA. This harmonization assures
industry that a documentation package submitted to one participating
regulatory agency can likewise be submitted to the other participating
agency, thus increasing standardization and decreasing the burden on
industry. EPA also believes that information submitted to EPA in the
XML schema format is intended to improve data quality and allow for a
more efficient pesticide registration process. To assist pesticide
registrants with the creation of the e-Submission XML packages, EPA has
established an e-Submission XML help desk. For more information about
electronic submissions, go to http://www.epa.gov/pesticides/regulating/
registering/submissions/index.htm.
b. Transmittal document. In order for EPA to effectively track the
compliance of each order recipient, each submission in satisfaction of
a FFDCA section 408(p) test order would need to be accompanied by a
transmittal document that includes the following information:
Identity of the submitter.
The date on which the submission package was prepared for
transmittal to EPA.
The FFDCA section 408(p) test order number.
Summary of the response commitment for each assay.
A list of the individual documents included in the
submission, with relationship to assay specified.
c. Individual study or test result documents. Unless otherwise
specified by the Agency, and varying based on the order recipient's
initial response, EPA would generally expect each submission package to
be in the form of individual documents or studies to address each assay
specified in the order. As indicated previously, EPA does not
anticipate the resubmission of previously submitted documents absent a
specific Agency request. Instead it would be sufficient for previously
submitted documents to be cited with adequate information to identify
the previously submitted document. EPA would typically expect each
study or document to include the following:
i. A title page including the following information:
The FFDCA section 408(p) test order number.
The title of the study, including identification of the
substance(s) tested and the test name or data requirement addressed.
The author(s) of the study.
The date the study was completed.
If the study was performed in a laboratory, the name and
address of the laboratory, project numbers or other identifying codes.
If the study is a commentary on or supplement to another
previously submitted study, full identification of the other study with
which it would be associated in review.
If the study is a reprint of a published document, all
relevant facts of publication, such as the journal title, volume,
issue, inclusive page numbers, and date of publication.
ii. Upon submission to EPA, any data confidentiality claims must be
accompanied by a signed and dated document containing the appropriate
statement(s) as described in the FFDCA section 408(p) test order, which
EPA expects would reference PR Notice 86-5 or other available Agency
guidance, as appropriate.
iii. A statement of compliance or non-compliance with respect to
GLP standards as described in 40 CFR part 160, as applicable.
iv. A complete and accurate English translation for any information
that is not in English.
5. Submit a written request for an extension. The FFDCA section
408(p) test order would identify a due date for submitting the data
specified to EPA. If an order recipient determines that they will not
be able to submit the data specified in the order to EPA by the due
date, the recipient can submit a written request for a time extension
that provides a clear rationale for the need for an extension, along
with any supporting documentation, in order to allow the Agency to
properly and timely assess the request. EPA intends to review all such
requests and send a written response to the requester in a timely
fashion. In most cases the original deadline would remain while EPA
considers the request. The Agency intends to only grant extensions that
were requested in writing. Ordinarily, extensions would only be
available in cases of extraordinary testing problems beyond the
expectation or control of the order recipient. Extensions would not be
considered if the request for extension is not made in a timely
fashion; or if it is submitted at or after the deadline. EPA intends to
only grant extension requests in writing.
6. Maintain records. EPA generally intends for the FFDCA section
408(p) test order to identify the following records that the recipient
would maintain as part of compliance with the order. Typically, the
Agency expects recipients to retain copies of the data and other
information submitted to the Agency in response to an order.
Under FIFRA section 8, all producers of pesticides, devices, or
active ingredients used in producing pesticides subject to FIFRA,
including pesticides produced pursuant to an experimental use permit
and pesticides, devices, and pesticide active ingredients produced for
export, are required to maintain certain records. As such, any
recipients who are pesticide registrants or who otherwise submit their
data in support of a pesticide registration will be held to the
recordkeeping standards in 40 CFR part 169. Consistent with 40 CFR
169.2(k), this includes all test reports submitted to the Agency in
support of a registration or in support of a tolerance petition, all
underlying raw data, and interpretations and evaluations thereof. Under
part 169, the registrant must retain these records as long as the
ingredient is contained in a pesticide product with a valid
registration and the producer is in business, and such records must be
made available to EPA or its agent for inspection upon request.
Recipients who are not a registrant would also be asked to retain
records related to the generation of the data and copies of other
information submitted to the Agency in response to the order. In
general, EPA would typically expect recipients who are not a registrant
to also retain such records for the same length of time as a
registrant, and to also make the records available to EPA or its agent
for inspection upon request.
G. What are the Consequences for a Recipient Who Fails to Respond or
Comply with the Test Order?
For pesticide active ingredients, FFDCA section 408(p)(5)(C)(i)
requires EPA to issue to any registrant that fails to comply with a
FFDCA section 408(p) test order ``a notice of intent to suspend the
sale or distribution of the substance by the registrant.'' The proposed
suspension ``shall become final at the end of the 30-day period
beginning on the date that the registrant receives the notice of intent
to suspend, unless during that period a person adversely affected by
the notice requests a hearing or the Administrator determines that the
registrant has complied'' with the
[[Page 17576]]
FFDCA section 408(p) test order. As specified by FFDCA section
408(p)(5)(C)(iii), the Administrator shall terminate a suspension if
the Administrator determines that the registrant has complied fully.
For all pesticide inert ingredient manufacturers/importers, FFDCA
section 408(p)(5)(D) provides for EPA to apply the penalties and
sanctions provided under section 16 of TSCA (15 U.S.C. 2615) ``to any
person (other than a registrant) who fails to comply with an [FFDCA
section 408(p)] order.''
H. Process for Contesting a Test Order/Pre-enforcement Review
FFDCA section 408(p) does not explicitly address the process for
challenging a test order (e.g., if the test order recipient disagrees
that a particular study is appropriate or valid). The statute only
specifies the rights and procedures available to test order recipients
who have failed to comply with a test order. Further, the issue is
somewhat complicated by the fact that the statute establishes different
procedures for enforcing the test orders against pesticide registrants
and against chemical manufacturers or importers. (Compare 21 U.S.C.
346a(p)(3)(C) and (D)). Nor is this issue resolved by FFDCA section
408's general judicial review provision; that provision is applicably
solely to the enumerated actions, which do not include FFDCA section
408(p) test orders. (21 U.S.C. 346a(h)). Consequently, FFDCA section
408(p) is ambiguous on a number of issues, such as the availability of
pre-enforcement review, and the issues that may be raised in an
enforcement hearing.
For pesticide registrants, FFDCA section 408(p)(5)(C) directs EPA
to initiate proceedings to suspend the registration when a registrant
fails to comply with a test order. (21 U.S.C. 346a(p)(3)(C)(i)). Prior
to the suspension, a registrant may request a hearing, but the statute
restricts the issues in the hearing solely to whether the registrant
has complied with the test order. (21 U.S.C. 346a(p)(3)(C)(ii)). The
substance of the test order may not be challenged during this hearing.
Thus, for example, to challenge whether EPA should have required a
particular study, the registrant would need to challenge the test order
itself in the appropriate district court. (See, e.g., Atochem v. EPA,
759 F.Supp. 861, 869-872 (D.D.C. 1991)). The basis for the statutory
restriction is that the FFDCA section 408(p) test order constitutes
final agency action, and as such, is subject to review upon issuance.
(See, Atochem, supra). In addition, as discussed above, EPA currently
intends to issue the test orders for testing of active ingredients
jointly under FFDCA section 408(p) and FIFRA section 3(c)(2)(B). The
procedures discussed above for challenging an FFDCA section 408(p) test
order are wholly consistent with the procedures applicable to FIFRA
section 3(c)(2)(B), which similarly limits the issues for resolution in
any suspension hearing held for failure to comply with the order. (See
7 U.S.C. 136a(c)(2)(B)(iv)). Accordingly, EPA believes that for
pesticide registrants, pre-enforcement review of the test order would
be available directly in federal district courts under any approach,
and based on the plain meaning of the statute, would be the only means
to obtain judicial review of the validity of the test order itself.
By contrast, FFDCA section 408(p)(5)(D) provides that non-
registrants (manufacturers or importers of pesticide inert ingredients)
are subject to monetary penalties through an enforcement proceeding,
using the process established by TSCA section 16. Under TSCA section
16, civil penalties of up to $25,000 per day may be assessed, after an
administrative hearing is held on the record in accordance with section
554 of the Administrative Procedures Act (APA). (15 U.S.C. 2615(a)(1)-
(2)(A)). Before issuing a final penalty order, EPA must provide notice
of its intention to assess the penalty, including a draft of the final
penalty order, and provide the recipient with the opportunity to
request a hearing within 15 days of the date the notice has been
received. (15 U.S.C. 2615(a)(2)(A)). (See also, 40 CFR 22.13-22.14).
TSCA section 16 also specifies that the following issues shall be taken
into account in determining the amount of a civil penalty: The nature,
circumstances, extent and gravity of the violation(s); the violator's
ability to pay; the effect on the violator's ability to continue to do
business; any history of prior violations; the degree of culpability;
and such other matters as justice may require. (15 U.S.C.
2615(a)(2)(B)).
Although neither FFDCA section 408(p) nor TSCA section 16 expressly
imposes the same restriction on the issues that a non-registrant may
raise in the penalty hearing, EPA's interpretation of the statutes and
existing regulations is to impose a similar restriction. In large
measure this interpretation turns on the fact that, at least for
pesticide registrants, FFDCA section 408(p) test orders constitute
final agency action, and consequently, would be subject to review in
the appropriate district court. Logically, it makes sense to interpret
the test order to be final for all parties, as the provisions of FFDCA
section 408(p)(5)(A) that describe the test order do not distinguish
between registrants and other test order recipients. Accordingly, pre-
enforcement judicial review of the test order will be available, and
would be the means by which any test order recipient would challenge
the validity of the test order. As a consequence of that
interpretation, EPA interprets TSCA section 16 to restrict the issues
that may be raised in any enforcement hearing to whether the test order
recipient had violated the test order, as well as the appropriate
amount of any penalty. This interpretation is consistent with the
issues listed in TSCA section 16(a)(2)(B), which do not expressly
relate to the validity of the underlying requirement.
I. Informal Administrative Review Procedure
EPA generally intends to include a provision in the FFDCA section
408(p) test order by which order recipients would raise any questions
or challenges concerning the issuance of the test order to the Agency
in response to the order. In addition, because the mere filing of the
objection (or indeed, the filing of a judicial challenge) would not
necessarily extend the deadline for submission of the studies, in order
for this process to be completed in a timely fashion, EPA expects order
recipients to present their objections with sufficient specificity and
detail to allow the Agency to adequately and fairly evaluate the
issue(s) presented. EPA intends to review the issues presented and
provide a written response within a reasonable amount of time. The
Agency understands that it will need to respond within sufficient time
for the order recipient to either comply with the order or determine
whether to pursue its concerns through judicial review.
J. How Would EPA Handle Responses from Recipients of Test Orders?
Just as there are many different, acceptable responses that
recipients may provide to a test order, so too are there many actions
that EPA may take. In some cases, a recipient's response would affect
only the recipient. This would be the case for a response from a test
order recipient:
Who claims that it is not subject to the order (see Unit
IV.F.1.d.); or
Who voluntarily cancels its registration (see Unit
IV.F.1.e.); or
Who reformulates its registered products (see Unit
IV.F.1.f.); or
[[Page 17577]]
Who claims that it qualifies for the formulator's
exemption (see Unit IV.F.1.g.); or
Who claims that it does not or no longer manufacture(s) or
import(s) the chemical (see Unit IV.F.1.h.).
Each of these responses would only affect the specific recipient's
obligation under the order. If EPA agreed with the response, the
recipient would not be required to generate the EDSP data (not subject
to the order or qualified for the formulator's exemption) or EPA would
cancel the recipient's registration as requested. EPA actions on these
kinds of responses would not affect other order recipients; they would
still be required to respond to the order by generating the data or
making one of the other acceptable responses.
In some cases, however, another recipient's response may have
consequences for other recipients. This would be the case for a
response from a test order recipient:
Who intends to generate the data (see Unit IV.F.1.a.); or
Who cites or submits existing data (see Unit IV.F.1.b.);
or
Who enter (or offer to enter) a joint agreement to
generate the data (see Unit IV.F.1.c.); or
Who commits to not sell their chemical for use in the
pesticide market (see Unit IV.F.1.i.).
The following discussion summarizes how EPA expects to handle
responses to test orders that may have consequences for other
recipients.
1. Publication order recipients, responses, and order status. As
noted earlier, EPA intends to publish the list of all order recipients
in the Federal Register and post the list on the Agency's website. The
Agency intends to also post the status of the testing orders, including
recipients' responses, on the Agency website so that both order
recipients and the public can check on the status of responses to the
orders. This information is intended to enable recipients of test
orders to identify and join other order recipients to develop the data
in response to the order, which in turn would help achieve EPA's goals
of minimizing duplicative testing and promoting fair and equitable
sharing of test costs. For example, if more than one recipient has
agreed to perform the required studies (see Unit IV.F.1.a.), it will be
reflected on the list and having this information will help them
explore the possibility of generating the data jointly. In addition, a
recipient who has agreed to generate required EDSP data can see all
other recipients who have informed the Agency that they would be
willing to share the cost of performing the required studies (see Unit
IV.F.1.b.). This information will aid in their sorting of offers to
share the cost of generating the required data from any recipient whom
EPA indicates has promised to make an offer to share test costs, but
has not yet contacted the recipient.
2. Publication of EPA decisions regarding reliance on existing data
or requests for an exemption under section 408(p)(4), and decisions
challenging the issuance of the test orders. The EPA website would also
contain information on decisions about whether a test recipient may
rely on existing data (see Unit IV.F.1.c.). If so, the Agency intends
to regard the existing data as meeting the requirement for all test
order recipients. Similarly, if EPA determines that a recipient has
demonstrated that the Agency should exempt the chemical from testing
under section 408(p)(4) (see Unit IV.F.1.h.), that decision would apply
equally to all test order recipients. Finally, a recipient's challenge
to the legal basis for a test order (see Unit IV.F.1.i.) might be
resolved in a way that affects the validity of the order for other
recipients. Publishing these decisions may also be considered by others
with similar questions.
3. Generation of data, tracking compensability of submitted data,
and enforcing compensation obligations. When EDSP data on an active
ingredient are submitted, EPA intends to handle the submission in the
same manner used under FIFRA. The name of the data submitter would be
added to the Data Submitters List and all future applicants for
registration of a pesticide containing the active ingredient would be
required to cite and offer to pay compensation in order to rely on the
data for the 15-year period following submission of such data.
In the case of EDSP data on pesticide inert ingredients, as
explained in Unit IV.C.2.c., EPA intends to establish a list (i.e., the
PIIDSSL) to identify any person who has submitted compensable data on a
pesticide inert ingredient in response to a test order issued under
FFDCA section 408(p). Assuming at least one recipient of a test order
submits the required EDSP data, EPA would add the name of the submitter
to the PIIDSSL under the name of the ingredient as an ``original data
submitter.'' The PIIDSSL would also include any other test order
recipient who has made an offer to share the cost of testing as an
``approved source,'' i.e., a source from whom an applicant or
registrant may obtain the pesticide inert and not have to offer to pay
compensation to the original data submitter. Since it is important to
have as complete a list of approved sources as possible, EPA encourages
original data submitters to identify additional companies as approved
sources, for example, because they have a contract to buy from the data
submitter. Then, pursuant to FIFRA section 3(c)(1)(F), when an
applicant's product contains a pesticide inert ingredient on the
PIIDSSL, the applicant would identify the source of the pesticide inert
ingredient. If the applicant's source does not appear on the PIIDSSL,
the applicant would either switch to a source on the PIIDSSL, offer to
pay compensation to the original data submitter(s) on the PIIDSSL, or
generate their own data.
EPA intends to also take a number of measures to ensure that
pesticide registrants are not obtaining the pesticide inert ingredient
from an ``unapproved'' source. Shortly after the receipt of test order
responses, EPA intends to make public the commitments made by
recipients of test orders-the names of the companies that have agreed
to generate (or share in the cost of generating) test data (``data
generators'') and the names of the companies that have committed to
discontinue selling into the pesticide market. If at least one order
recipient has agreed to generate the required data, EPA intends to
inform registrants that in the future they will need to obtain the
pesticide inert ingredient only from a data submitter or approved
source, offer to pay compensation to the data submitter for the right
to rely on existing data, or generate new data.
The Agency thinks these procedures will result in a system that
effectively provides data use protections to generators of EDSP data on
pesticide active and inert ingredients. Through this system all
manufacturers and importers of pesticide inert ingredients will
understand whether or not they are allowed to sell into the pesticide
market. If a manufacturer or importer takes the necessary steps that
allow it to sell into the pesticide market, such a company would be
listed on the PIIDSSL. Those manufacturers and importers whose products
reached the pesticide market through other suppliers could add the
names of the suppliers to the PIIDSSL. Similarly, through this system,
applicants for new products and registrants of existing products will
understand from which sources they may purchase a pesticide inert
ingredient without having to offer to pay compensation, or without
running the risk of needing to generate their own data.
The Agency recognizes that these safeguards do not automatically
ensure compliance with the data use
[[Page 17578]]
protections. But the Agency expects that manufacturers and importers
who commit not to sell their chemical into the pesticide market will
adhere to this promise and will work with their customers to ensure
they also observe this market constraint.
EPA also intends to take steps to try to prevent companies from
inadvertently subverting the commitment made by order recipients. For
example, the Agency's Federal Register document that announces the
issuance of the FFDCA section 408(p) order(s), would also inform those
companies who sell a chemical that is used as a pesticide inert
ingredient (other than test order recipients) that they may receive and
become subject to an FFDCA section 408(p) order if they obtain the
pesticide inert ingredient (either directly or indirectly) from a
source who has not committed to generate the EDSP data but then sell
the pesticide inert ingredient into the pesticide market. EPA intends
to inform manufacturers who agree to generate the data that EPA intends
to rely on them to bring to EPA's attention information indicating that
a pesticide registrant appears to be obtaining the pesticide inert
ingredient from an ``unapproved'' source. As indicated previously, EPA
intends to issue ``catch-up'' orders to any manufacturer or importer of
a pesticide inert ingredient who enters the market place after EPA has
issued a test order for that ingredient.
4. All test order recipients for a pesticide inert ingredient ``opt
out'' of the pesticide market. If no test order recipient has agreed to
generate the required data, the Agency intends to issue a Federal
Register notice informing registrants that the pesticide inert
ingredient will no longer be available for use in formulating pesticide
products unless someone commits to generate the required data. EPA
intends to ask for a commitment to generate the required data within 6
months of publication. After that date, EPA would take steps to remove
the pesticide inert ingredient from its list of cleared pesticide
inerts and to revoke any tolerances or tolerance exemptions for the
pesticide inert ingredient. EPA would also remind registrants that
under existing regulations, they must apply to amend their
registrations before they may sell a pesticide product that has a
composition that differs from the approved Confidential Statement of
Formula for the product. On a case-by-case basis, EPA may issue a DCI
notice and/or a section 408(p) test order for the required data to
registrants whose products contain the pesticide inert ingredient.
K. Adverse Effects Reporting Requirements
Under FIFRA section 6(a)(2), pesticide product registrants are
required to submit adverse effects information about their products to
the EPA. Among other things, the implementing regulations in 40 CFR
part 159, subpart D provide registrants with detailed instructions on
whether, when, and how to report information in the possession of the
registrant or its agents.
In addition, under TSCA section 8(c), companies can be required to
record, retain and in some cases report ``allegations of significant
adverse reactions'' to any substance/mixture that they produce, import,
process, or distribute. EPA's TSCA section 8(c) rule requires
producers, importers, and certain processors of chemical substances and
mixtures to keep records concerning significant adverse reaction
allegations and report those records to EPA upon notice in the Federal
Register or upon notice by letter. The TSCA section 8(c) rule also
provides a mechanism to identify previously unknown chemical hazards in
that it may reveal patterns of adverse effects which otherwise may not
be otherwise noticed or detected. Further information is available
under 40 CFR part 717.
Under TSCA section 8(e), U.S. chemical manufacturers, importers,
processors, and distributors are required to notify EPA within 30
calendar days of new, unpublished information on their chemicals that
may lead to a conclusion of substantial risk to human health or to the
environment. The term ``substantial risk'' information refers to that
information which offers reasonable support for a conclusion that the
subject chemical or mixture poses a substantial risk of injury to
health or the environment and need not, and typically does not,
establish conclusively that a substantial risk exists. For additional
information about TSCA section 8(e), please go to http://www.epa.gov/
oppt/chemtest/pubs/sect8e.htm.
EPA does not require duplicate submission of EDSP results under
FIFRA section 6(a)(2) or TSCA section 8(c) or (e). Any information
submitted under FIFRA section 6(a)(2) or TSCA section 8(c) or 8(e)
procedures does not need to be submitted again to satisfy the FFDCA
section 408(p) test order. The test order recipient would instead
submit the necessary information to cite to the previously submitted
information as described earlier in this document.
V. Statutory and Executive Order Reviews
A. Regulatory Planning and Review
Under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993), EPA submitted this document to
the Office of Management and Budget (OMB) for review. Any changes made
in response to OMB recommendations have been documented in the docket
for this action as required by section 6(a)(3)(E) of the Executive
Order.
B. Paperwork Reduction Act (PRA)
The information collection requirements associated with issuing
orders for Tier 1 screening under the EDSP have been submitted for
review and approval by OMB under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq. An agency may not conduct or sponsor, and a person
is not required to respond to a collection of information unless it
displays a currently valid OMB control number. As a new ICR, the Agency
does not yet have an OMB control number for this information collection
activity. Once assigned, EPA will announce the OMB control number for
this information collection in the Federal Register, and will add it to
any related collection instruments or forms used, and include it in the
orders issued.
A copy of the final ICR package submitted to OMB for review and
approval under the PRA (identified under EPA ICR No. 2249.01) has been
placed in the docket for this policy. A draft of the ICR package was
issued for public comment pursuant to the PRA and 5 CFR 1320.8(d) on
December 13, 2007 (72 FR 70839) (FRL-8155-8). The ICR has been revised
to address comments received, and the following is a brief summary of
the final ICR package that was submitted to OMB for approval under the
PRA and which describes the information collection activities discussed
in the final policy and procedures document, along with EPA's estimated
burden in more detail.
Under the PRA, ``burden'' is defined at 5 CFR 1320.3(b). For the
purposes of this ICR, the information collection activities include
reviewing the order, providing the initial response, participating in a
consortia, generating the data, preparing and submitting a progress
report, submitting the data, requesting an extension, and maintaining
records. As described in more detail in the ICR, the total estimated
per chemical/per respondent paperwork burden is 3,008 hours, with an
estimated cost of $212,369. Annualized over 3 years, the per
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respondent burden is 1,003 hours, and the cost is $70,790. The total
annualized estimated paperwork burden for this ICR is 108,364 hours,
with an estimated total annual cost of $7,478,116 million. Although
individual respondent burden varies based on their individual
activities, this estimate assumes that the respondent actively
participates in all potential activities, including developing
consortia, generating all of the potential data, submitting a progress
report, requesting an extension, and submitting the data.
Pursuant to 5 CFR 1320.12, the submission of the ICR to OMB, along
with a solicitation of comments on that ICR, is addressed in a separate
document published elsewhere in today's Federal Register. Please follow
the instructions in that document to view the ICR and submit comments
on the revised ICR.
VI. References
The following is a list of the documents that are specifically
referenced in this document and placed in the docket that was
established under Docket ID number EPA-HQ-OPPT-2007-1080. For
information on accessing the docket, refer to the ADDRESSES unit at the
beginning of this document.
1. EPA. Endocrine Disruptor Screening and Testing Advisory
Committee (EDSTAC) Final Report. August 1998. http://www.epa.gov/
scipoly/oscpendo/pubs/edspoverview/finalrpt.htm.
2. Organization for Economic Cooperation and Development (OECD).
Final Report of the OECD Workshop on Harmonization of Validation and
Acceptance Criteria for Alternative Toxicological Test Methods. August
1996.
3. EPA. Response to Comments on the Endocrine Disruptor Screening
Program: Draft Policies and Procedures for Initial Screening and
Testing. March 2009.
4. EPA. EPA's Approach for Considering Other Scientifically
Relevant Information (OSRI) under the Endocrine Disruptor Screening
Program. March 17, 2009.
List of Subjects
Environmental protection, Chemicals, Endocrine disruptors,
Pesticides and pests, Reporting and recordkeeping.
Dated: April 3, 2009.
James Jones,
Acting Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. E9-8706 Filed 4-14-09; 8:45 am]
BILLING CODE 6560-50-S