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U.S. Code as of:
01/03/05
Section 136h. Protection of trade secrets and other information
(a) In general
In submitting data required by this subchapter, the applicant may
(1) clearly mark any portions thereof which in the applicant's
opinion are trade secrets or commercial or financial information
and (2) submit such market material separately from other material
required to be submitted under this subchapter.
(b) Disclosure
Notwithstanding any other provision of this subchapter and
subject to the limitations in subsections (d) and (e) of this
section, the Administrator shall not make public information which
in the Administrator's 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 subchapter, information
relating to formulas of products acquired by authorization of this
subchapter 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) of this section, the
Administrator 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) of
this section.
(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 136a of this title. 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
described 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 of such information of the intent to
release such information. The Administrator may not release 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 disclosure
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 information.
(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 subchapter 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 officer or employee of the United States or former
officer or employee 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 shall not apply
with respect to the publishing, divulging, disclosure, or making
known of, or making available, information reported or otherwise
obtained under this subchapter. Nothing in this subchapter 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 subchapter 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 subchapter,
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 shall apply to any affirmation made
under paragraph (1) of this subsection.
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