1.This Act may be cited as the
Endocrine Disruptor Screening
Enhancement Act of 2010
.
2.Endocrine
disruptor screening programSection 1457 of the Safe Drinking Water Act
(42 U.S.C. 300j–17) is amended to read as follows:
1457.Endocrine disruptor screening program(a)
(1)In
carrying out the screening program under section 408(p) of the Federal Food,
Drug, and Cosmetic Act, the Administrator shall provide for the testing of
substances described in paragraph (2) in addition to the substances described
in section 408(p)(3) of such Act.
(2)A
substance is subject to testing pursuant to paragraph (1) if—
(A)the substance may be found in sources
of drinking water; and
(B)the Administrator determines that a
substantial population may be exposed to such substance.
(3)Substances already subject to
testingNotwithstanding paragraph (2), a substance is not subject
to testing pursuant to paragraph (1) if—
(A)the substance is already subject to
evaluation determined by the Administrator to be equivalent to testing pursuant
to paragraph (1); or
(B)the Administrator has already
determined the effect of the substance on the endocrine system.
(4)Substances derived from degradation
or metabolism of another substanceIf a substance subject to
testing pursuant to paragraph (1) (in this paragraph referred to as the
covered substance
) is derived from the degradation or metabolism
of another substance, or is used in or generated by the manufacture of another
substance, the Administrator shall provide for such testing of the covered
substance by the importer or manufacturer of the other substance.
(b)Identification
and testing of endocrine disrupting substances that may be in drinking
water
(1)Not
later than 1 year after the date of the enactment of the
Endocrine Disruptor Screening Enhancement Act
of 2010, after opportunity for comment, the Administrator shall
publish—
(A)a list of no fewer
than 100 substances for testing pursuant to subsection (a)(1) (in accordance
with the schedule specified in paragraph (3)); and
(B)a plan for the identification of additional
substances for testing pursuant to subsection (a)(1), and a schedule for
issuing test orders for all such additional substances by not later than 10
years after the date of the enactment of the Endocrine Disruptor Screening Enhancement Act of
2010, with the goal of testing, at a minimum and consistent with
subsection (a), all substances that have been placed on the Drinking Water
Preliminary Contaminant Candidate List published pursuant to section
1412(b)(1)(B)(i).
In
publishing the plan and schedule required by subparagraph (B), the
Administrator shall obtain advice and direction from the Science Advisory
Board.(2)Prioritization;
considerationsIn selecting substances for listing under
paragraph (1)(A) or identification pursuant to the plan under paragraph (1)(B),
the Administrator—
(A)shall prioritize
the selection of substances that pose the greatest public health concern,
taking into consideration (among other factors of public health concern) the
effect of such substances on subgroups that comprise a meaningful portion of
the general population (such as infants, children, pregnant women, the elderly,
individuals with a history of serious illness, and other subpopulations) that
are identifiable as being at greater risk of adverse health effects due to
exposure to substances in drinking water; and
(B)shall take into
consideration—
(i)available
information on the extent of potential public exposures to the substances
through drinking water; and
(ii)the Drinking
Water Preliminary Contaminant Candidate List published pursuant to section
1412(b)(1)(B)(i).
(3)After
publication of the list under paragraph (1)(A), the Administrator shall issue
test orders for—
(A)at least 25
substances on the list by the end of each year during the 4-year period
following the date of the enactment of the Endocrine Disruptor Screening Enhancement Act of
2010; and
(B)all substances on
the list by the end of such 4-year period.
(c)
(1)Not later than 2 years after the date of the enactment of
the Endocrine Disruptor Screening Enhancement
Act of 2010, the Administrator shall, after opportunity for
comment, and after obtaining advice and direction from the Science Advisory
Board, publish guidance on developing and updating protocols for testing of
possible endocrine disruptors. The guidance shall specify—
(A)the manner in
which the Administrator will evaluate and, where necessary, revise such
protocols;
(B)the manner in
which the Administrator will determine when testing of substances will be
required; and
(C)the procedures by which other
scientifically relevant information can be used in lieu of some or all of the
information that otherwise would be collected pursuant to testing under section
408(p) of the Federal Food, Drug, and Cosmetic Act.
(2)The procedures
specified pursuant to paragraph (1)(C) shall ensure that the Administrator may
use information that is prepared or provided by any person (including a
registrant, manufacturer, or importer of a substance for which testing is
required, and any other entity) and shall apply equally with respect to any
such person.
(3)The
Administrator may, after opportunity for comment, and after obtaining advice
and direction from the Science Advisory Board, amend any guidance published
pursuant to this subsection.
(d)Revision of
testing protocolsNot later
than 2 years after the date of the enactment of the
Endocrine Disruptor Screening Enhancement Act
of 2010, the Administrator shall, after opportunity for comment,
determine whether sufficient scientific information has been developed to
warrant updating the screening protocols developed under section 408(p) of the
Federal Food, Drug, and Cosmetic Act. Not later than 5 years after the date of
the enactment of the Endocrine Disruptor
Screening Enhancement Act of 2010 and every 3 years thereafter,
the Administrator shall determine, consistent with the guidance published under
subsection (c), whether to revise screening protocols under such section based
on significant improvements in the sensitivity, accuracy, reliability,
reproducibility, or efficiency of such protocols. Whenever the Administrator
revises such a protocol, the Administrator shall also determine, after
obtaining advice and direction from the Science Advisory Board or the advisory
panel referred to in section 25(d) of the Federal Insecticide, Fungicide, and
Rodenticide Act, as appropriate, whether any substance that has already been
subjected to testing should be tested using the revised protocol.
(e)Acceleration of
testing for certain substances
(1)If the Administrator determines that—
(A)a substance is
known to be found in sources of drinking water,
(B)a substantial
population is known to be exposed to the substance, and
(C)the substance is
either suspected to be an endocrine disruptor or has a structural similarity to
a substance known to be an endocrine disruptor,
the
Administrator shall determine whether to require the completion of testing for
such substance on an accelerated schedule, to enable the Administrator to
determine the effect of such substance on the endocrine system and ensure the
protection of public health.(2)Scientifically
relevant informationThe Administrator shall make any
determination under paragraph (1) using scientifically relevant information. In
carrying out the preceding sentence, the Administrator may rely on any
available scientifically relevant information, prepared or provided by any
person.
(3)Not
later than 1 year after the date of the enactment of the
Endocrine Disruptor Screening Enhancement Act
of 2010, the Administrator shall, after opportunity for comment,
publish guidance on how the Administrator will make determinations under
paragraph (1).
(f)
(1)Publication of
data evaluation recordsNot later than 6 months after receipt of
testing results for a substance, the Administrator shall prepare and,
consistent with subsection (g), publish data evaluation records for such
results in a publicly searchable database.
(2)Not later than 6 months after receipt of testing results
for a substance, the Administrator shall—
(A)determine whether to take action related to
the substance under section 1412(b) or 1445, or other appropriate statutory
authority; and
(B)consistent with
subsection (g), publish such determination in a publicly searchable
database.
(3)Structured
evaluation frameworkTo
assess the overall weight of the evidence and relevance to humans and wildlife
of results of testing, the Administrator shall develop and use a structured
evaluative framework consisting of science-based criteria, consistent with the
protection of public health and the environment, for systematically evaluating
endocrine mode of action and for determining data relevance, quality, and
reliability.
(g)Beginning not later than 180 days after the date of the
enactment of the Endocrine Disruptor
Screening Enhancement Act of 2010 and consistent with section 552
of title 5, United States Code, the Administrator shall publish, in electronic
format, a publicly searchable database that contains information regarding the
testing program. Not later than 30 days after the date on which the information
becomes available, the Administrator shall ensure that, at a minimum, the
database—
(1)identifies the
substances selected for testing under the program; and
(2)includes the
documents and information pertaining to the status of testing activities for
each such substance, including test orders, deadlines for submission, the
Environmental Protection Agency’s data evaluation records, the Administrator’s
determination on whether regulatory action will be taken under subsection (f),
and the summary of chemical test results.
(h)Petition for
inclusion of a substance in the program
(1)Any person may submit a petition the Administrator
to—
(A)add a substance
to the list under subsection (b)(1)(A) or identify a substance pursuant to the
plan under subsection (b)(1)(B); or
(B)issue a test order
requiring that a substance be tested on an accelerated basis in accordance with
subsection (e).
(2)Any petition under
paragraph (1) shall specify the facts that are claimed to establish that an
action described in subparagraph (A) or (B) of paragraph (1) is
warranted.
(3)Not later than 90 days after the filing of a petition
described under paragraph (1), the Administrator shall determine whether the
petition has established that an action described in subparagraph (A) or (B) of
paragraph (1) is warranted and shall grant or deny the petition. If the
Administrator grants such petition, the Administrator shall promptly add the
substance to the list under subsection (b)(1)(A), identify the substance
pursuant to the plan under subsection (b)(1)(B), or issue an order requiring
testing on an accelerated basis in accordance with subsection (e), as
applicable. If the Administrator denies the petition, the Administrator shall
publish the reasons for such denial in the Federal Register.
(i)Coordination
with other Federal agenciesAfter the Administrator—
(1)requires testing
of a substance, or
(2)based in whole or in part on the results of
testing, takes action related to a substance under section 1412(b) or 1445 or
other appropriate statutory authority,
the
Administrator shall give notice of such testing or action to Federal agencies
which are authorized by other provisions of law to regulate the substance or
products, materials, medications, processes, or practices that use the
substance.(j)Not later than 1 year after the date of the enactment
of the Endocrine Disruptor Screening
Enhancement Act of 2010 and every 3 years thereafter, the
Administrator shall provide a report to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Environment and Public Works
of the Senate that describes—
(1)progress made in
identifying, testing, and regulating endocrine disruptors as well as plans for
future activities;
(2)any change in
screening or testing methodology and evaluation or criteria for evaluating
scientifically relevant information; and
(3)actions taken to
ensure communication and sharing of scientific information with other Federal
agencies and the public; and
(4)any deviations from the plan or schedule
published under subsection (b)(1)(B) as well as the reasons therefor.
(k)Testing
consortia, compensation, and compliance
(1)Any person required by the Administrator to conduct
testing of an endocrine disruptor may—
(A)submit, on its
own, data in response to an order for such testing; and
(B)form (on a
voluntary basis) a consortium in order to satisfy the requirements of one or
more orders for such testing.
(2)Reliance on
consortium submissionsEach member of a consortium described in
paragraph (1)(B) shall have full rights to rely on all submissions of the
consortium to satisfy the requirements of any order for testing, but continues
to be individually subject to such requirements.
(3)
(A)Each member of a consortium described in paragraph (1)(B)
shall share the applicable costs according to appropriate arrangements
established by the consortium members.
(B)Whenever, to satisfy
the requirements of one or more orders for testing, any person offers to form
or join a consortium described in paragraph (1)(B), or offers compensation to a
person that has already submitted data to the Administrator satisfying an order
for testing, such offer shall constitute a binding offer to share an
appropriate portion of the applicable costs.
(C)In this subsection, the term applicable costs
includes the costs—
(i)incurred to
generate and report information to comply with an order for testing; or
(ii)associated with
the organization and administration of the consortium.
(4)
(A)In the event of any dispute about an appropriate share or
a fair method of determining an appropriate share of applicable costs of the
testing requirements in a test order, any person involved in the dispute may
initiate binding arbitration proceedings by requesting the Federal Mediation
and Conciliation Service to appoint an arbitrator from the roster of
arbitrators maintained by such Service or a hearing with a regional office of
the American Arbitration Association. A copy of the request shall be sent to
each person from whom the requesting party seeks compensation or who seeks
compensation from that party.
(B)No review of
findings and determinationThe findings and determination of the
arbitrator in a dispute initiated pursuant to subparagraph (A) shall be final
and conclusive, and no official or court of the United States shall have power
or jurisdiction to review any such findings and determination, except in the
case of fraud, misrepresentation, or other misconduct by one of the parties to
the arbitration or by the arbitrator.
(C)Payment of fee
and expensesThe parties to arbitration initiated pursuant to
subparagraph (A) shall share equally in the payment of the fee and expenses of
the arbitrator.
(5)If
the Administrator determines that any person seeking to comply with an order
for testing by relying on a submission made by a consortium or an original data
submitter has failed to make an offer in accordance with paragraph (3)(B), to
participate in an arbitration proceeding under paragraph (4), or to comply with
the terms of an agreement or arbitration decision concerning sharing of
applicable costs under paragraph (3), that person is deemed to have failed to
comply with an order under subparagraph (A) of section 408(p)(5) of the Federal
Food, Drug, and Cosmetic Act for purposes of subparagraphs (B) and (C) of such
section.
(l)In
this section:
(1)The term
endocrine disruptor means an exogenous agent or mixture of agents
that interferes or alters the synthesis, secretion, transport, metabolism,
binding action, or elimination of hormones that are present in the body and are
responsible for homeostasis, growth, neurological signaling, reproduction and
developmental process, or any other effect that the Administrator has
designated as an endocrine effect
pursuant to section 408(p)(1)
of the Federal Food, Drug, and Cosmetic Act.
(2)The term
testing means the testing of a substance pursuant to the screening
program under section 408(p) of the Federal Food, Drug, and Cosmetic Act,
including a test of a substance that is intended to identify substances that
have the potential to interact with the endocrine system or that is intended to
determine the endocrine-related effects caused by such substance and obtain
information about effects at various doses.
(m)Authorization of
appropriationsTo carry out
this section, there is authorized to be appropriated $5,000,000 for each of
fiscal years 2011 through
2015.
.