SEC.
10. [136h] PROTECTION OF TRADE SECRETS AND OTHER INFORMATION.
(a) IN GENERAL.-In
submitting data required by this Act, the applicant may (1) clearly
mark any portions thereof which in his opinion are trade secrets
or commercial or financial information and (2) submit such marked
material separately from other material required to be submitted
under this Act.
(b) DISCLOSURE.-Notwithstanding any other provision of this
Act and subject to the limitations in subsections (d) and (e)
of this section, the Administrator shall not make public information
which in his judgment contains or relates to trade secrets or
commercial or financial information obtained from a person and
privileged or confidential, except that, when necessary to carry
out the provisions of this Act, information relating to formulas
of products acquired by authorization of this Act may be revealed
to any Federal agency consulted and may be revealed at a public
hearing or in findings of fact issued by the Administrator.
(c) DISPUTES.-If the Administrator proposes to release
for inspection information which the applicant or registrant
believes to be protected from disclosure under subsection (b),
he shall notify the applicant or registrant, in writing, by certified
mail. The Administrator shall not thereafter make available for
inspection such data until thirty days after receipt of the notice
by the applicant or registrant. During this period, the applicant
or registrant may institute an action in an appropriate district
court for a declaratory judgment as to whether such information
is subject to protection under subsection (b).
(d) LIMITATIONS.-
(1) All information concerning the objectives, methodology,
results, or significance of any test or experiment performed
on or with a registered or previously registered pesticide or
its separate ingredients, impurities, or degradation products,
and any information concerning the effects of such pesticide
on any organism or the behavior of such pesticide in the environment,
including, but not limited to, data on safety to fish and wildlife,
humans and other mammals, plants, animals, and soil, and studies
on persistence, translocation and fate in the environment, and
metabolism, shall be available for disclosure to the public.
The use of such data for any registration purpose shall be governed
by section 3 of this Act. This paragraph does not authorize the
disclosure of any information that-
(A) discloses
manufacturing or quality control processes,
(B) discloses the details of any methods for testing, detecting,
or measuring the quantity of any deliberately added inert ingredient
of a pesticide, or
(C) discloses the identity or percentage quantity of any deliberately
added inert ingredient of a pesticide, unless the Administrator
has first determined that disclosure is necessary to protect
against an unreasonable risk of injury to health or the environment. |
(2) Information concerning production, distribution, sale, or
inventories of a pesticide that is otherwise entitled to confidential
treatment under subsection (b)of this section may be publicly
disclosed in connection with a public proceeding to determine
whether a pesticide, or any ingredient of a pesticide, causes
unreasonable adverse effects on health or the environment, if
the Administrator determines that such disclosure is necessary
in the public interest.
(3) If the Administrator proposes to disclose information de-scribed
in clause (A), (B), or (C) of paragraph (1) or in paragraph (2)
of this subsection, the Administrator shall notify by certified
mail the submitter oFsuch information of the intent to release
such information. The Administrator may not re-lease such information,
without the submitter's consent, until thirty days after the
submitter has been furnished such notice. Where the Administrator
finds that disclosure of information described in clause (A),
(B), or (C) of paragraph (1) of this subsection is necessary
to avoid or lessen an imminent and substantial risk of injury
to the public health, the Administrator may set such shorter
period of notice (but not less than ten days) and such method
of notice as the Administrator finds appropriate. During such
period the data submitter may institute an action in an appropriate
district court to enjoin or limit the proposed disclosure. The
court may enjoin disclosure, or limit the disclosure or the parties
to whom disclosure shall be made, to the extent that-
(A) in the case of information described in clause (A), (B),
or (C) of paragraph (1) of this subsection, the proposed dis-closure
is not required to protect against an unreasonable risk of injury
to health or the environment; or
(B) in the case of information described in paragraph (2) of
this subsection, the public interest in availability of the information
in the public proceeding does not outweigh the interests in preserving
the confidentiality of the informa-tion.
(e) DISCLOSURE TO CONTRACTORs.-Information otherwise protected
from disclosure to the public under subsection (b) of this section
may be disclosed to contractors with the United States and employees
of such contractors if, in the opinion of the Administrator,
such disclosure is necessary for the satisfactory performance
by the contractor of a contract with the United States for the
performance of work in connection with this Act and under such
conditions as the Administrator may specify. The Administrator
shall require as a condition to the disclosure of information
under this subsection that the person receiving it take such
security precautions respecting the information as the Administrator
shall by regulation prescribe.
(f) PENALTY FOR DISCLOSURE BY FEDERAL EMPLOYEES.-
(1) Any office or employee of the United States or former officer
or employ-ee of the United States who, by virtue of such employment
or official position, has obtained possession of, or has access
to, material the disclosure of which is prohibited by subsection
(b) of this section, and who, knowing that disclosure of such
material is prohibited by such subsection, willfully discloses
the material in any manner to any person not entitled to receive
it, shall be fined not more than $10,000 or imprisoned for not
more than one year, or both. Section 1905 of title 18 of the
United States Code shall not apply with respect to the publishing,
divulging, disclosure, or making known of, or making available,
information reported or otherwise obtained under this Act. Nothing
in this Act shall preempt any civil remedy under State or Federal
law for wrongful disclosure of trade secrets.
(2) For the purposes of this section, any contractor with the
United States who is furnished information as authorized by subsection
(e) of this section, or any employee of any such contractor,
shall be considered to be an employee of the United States.
(g) DISCLOSURE TO FOREIGN AND MULTINATIONAL PESTICIDE PRODUCERS.-
(1) The Administrator shall not knowingly disclose information
submitted by an applicant or registrant under this Act to any
employee or agent of any business or other entity engaged in
the production, sale, or distribution of pesticides in countries
other than the United States or in addition to the United States
or to any other person who intends to deliver such data to such
foreign or multinational business or entity unless the applicant
or registrant has consented to such disclosure. The Administrator
shall require an affirmation from any person who intends to inspect
data that such person does not seek access to the data for purposes
of delivering it or offering it for sale to any such business
or entity or its agents or employees and will not purposefully
deliver or negligently cause the data to be delivered to such
business or entity or its agents or employees. Notwithstanding
any other provision of this subsection, the Administrator may
disclose information to any person in connection with a public
proceeding under law or regulation, subject to restrictions on
the availability of information contained elsewhere in this Act,
which information is relevant to a determination by the Administrator
with respect to whether a pesticide, or any ingredient of a pesticide,
causes unreasonable adverse effects on health or the environment.
(2) The Administrator shall maintain records of the names of
persons to whom data are disclosed under this subsection and
the persons or organizations they represent and shall inform
the applicant or registrant of the names and affiliations of
such persons.
(3) Section 1001 of title 18 of the United States Code shall
apply to any affirmation made under paragraph (1) of this subsection. |
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