§ 136h. — Protection of trade secrets and other information.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 7USC136h]
TITLE 7--AGRICULTURE
CHAPTER 6--INSECTICIDES AND ENVIRONMENTAL PESTICIDE CONTROL
SUBCHAPTER II--ENVIRONMENTAL PESTICIDE CONTROL
Sec. 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.
(June 25, 1947, ch. 125, Sec. 10, as added Pub. L. 92-516, Sec. 2, Oct.
21, 1972, 86 Stat. 989; amended Pub. L. 95-396, Sec. 15, Sept. 30, 1978,
92 Stat. 829; Pub. L. 98-620, title IV, Sec. 402(4)(B), Nov. 8, 1984, 98
Stat. 3357; Pub. L. 100-532, title VIII, Sec. 801(f), Oct. 25, 1988, 102
Stat. 2682; Pub. L. 102-237, title X, Sec. 1006(b)(1), (2), (3)(J), Dec.
13, 1991, 105 Stat. 1895, 1896.)
Prior Provisions
A prior section 10 of act June 25, 1947, was classified to section
135h of this title prior to amendment of act June 25, 1947, by Pub. L.
92-516.
Amendments
1991--Subsec. (a). Pub. L. 102-237, Sec. 1006(b)(3)(J), substituted
``the applicant's'' for ``his''.
Subsec. (b). Pub. L. 102-237, Sec. 1006(b)(2), substituted ``the
Administrator's'' for ``his''.
Subsec. (c). Pub. L. 102-237, Sec. 1006(b)(1), substituted ``the
Administrator'' for ``he'' before ``shall notify''.
1988--Subsec. (d). Pub. L. 100-532 in par. (1), substituted
``public. The use'' for ``public: Provided, That the use'' and ``title.
This paragraph'' for ``title: Provided further, That this paragraph'',
and in par. (3), ``notice. Where'' for ``notice: Provided, That where''.
1984--Subsec. (d)(3). Pub. L. 98-620 struck out provisions requiring
the court to give expedited consideration to actions involving
injunctions or limitations of proposed disclosure.
1978--Subsec. (b). Pub. L. 95-396, Sec. 15(1), made disclosure of
information by the Administrator subject to the limitations of subsecs.
(d) and (e) of this section.
Subsecs. (d) to (g). Pub. L. 95-396, Sec. 15(2), added subsecs. (d)
to (g).
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-532 effective on expiration of 60 days
after Oct. 25, 1988, see section 901 of Pub. L. 100-532, set out as a
note under section 136 of this title.
Effective Date of 1984 Amendment
Amendment by Pub. L. 98-620 not applicable to cases pending on Nov.
8, 1984, see section 403 of Pub. L. 98-620, set out as an Effective Date
note under section 1657 of Title 28, Judiciary and Judicial Procedure.
Effective Date
For effective date of section, see section 4 of Pub. L. 92-516, set
out as a note under section 136 of this title.
Section Referred to in Other Sections
This section is referred to in sections 136a, 136e of this title;
title 21 section 346a.