7 U.S.C. § 136h — Protection of trade secrets and other information

submitted 79 years ago by Pub. L. 92-516 to r/title-7-AGRICULTURE · 1,344 words · no verdicts yet

in plain englishAI-generated · not legal advice

Applicants can mark data as trade secrets or commercial information, and the EPA usually keeps it confidential. But test results on safety and environmental effects of a registered pesticide must be disclosed to the public. The EPA must notify a submitter before releasing protected data, and the submitter can sue to stop it.

(a) In general. When submitting data required by this law, an applicant may (1) clearly mark any parts it believes are trade secrets or commercial or financial information, and (2) submit that marked material separately from the rest. (b) Disclosure. Subject to the limits in (d) and (e), EPA generally must not make public any information it judges to be a trade secret or privileged/confidential commercial or financial information obtained from someone. An exception: when necessary to carry out this law, information about a pesticide's formula can be shared with a federal agency EPA consults, or revealed at a public hearing or in EPA's factual findings. (c) Disputes. If EPA plans to release information the applicant or registrant believes is protected under (b), EPA must notify them in writing by certified mail and then wait at least 30 days before releasing it. During that time, the applicant or registrant can sue in federal district court for a declaratory judgment on whether the information is really protected. (d) Limitations. (1) All information about the objectives, methods, results, or significance of any test on a registered (or previously registered) pesticide or its ingredients, impurities, or breakdown products — and any information about the pesticide's effects on any organism or in the environment, including safety data on fish, wildlife, humans, other mammals, plants, animals, soil, persistence, movement, and metabolism — must be available to the public. Section 136a governs how such data can be used for registration purposes. But this doesn't allow disclosure of information that (A) reveals manufacturing or quality-control processes, (B) reveals the details of methods for testing or measuring a deliberately added inert ingredient, or (C) reveals the identity or percentage of a deliberately added inert ingredient — unless EPA first decides disclosure is necessary to protect against an unreasonable risk of harm to health or the environment. (2) Information about a pesticide's production, distribution, sale, or inventory that would otherwise be confidential under (b) can be publicly disclosed in a public proceeding about whether the pesticide causes unreasonable adverse effects, if EPA decides that's necessary in the public interest. (3) Before disclosing information described in (1)(A)-(C) or in (2), EPA must notify the submitter by certified mail of its intent to release it, and can't release it without consent until 30 days after that notice — except EPA can shorten that notice period to as little as 10 days if disclosure is necessary to avoid or reduce an imminent, substantial risk to public health. During the notice period, the submitter can sue in federal district court to block or limit the disclosure. The court can block or limit it if (A) for (1)(A)-(C) information, the disclosure isn't actually required to protect against unreasonable risk to health or the environment, or (B) for (2) information, the public interest in disclosure doesn't outweigh the interest in keeping it confidential. (e) Disclosure to contractors. Information otherwise protected under (b) can be shared with U.S. government contractors and their employees if EPA decides it's necessary for the contractor to do work related to this law, under conditions EPA sets — including security precautions EPA requires by regulation. (f) Penalty for disclosure by federal employees. (1) A current or former federal officer or employee who gets access to protected material through their job, knows disclosure is prohibited, and willfully discloses it to someone not entitled to receive it, can be fined up to $10,000, imprisoned up to one year, or both. A separate federal secrecy law (18 U.S.C. § 1905) doesn't limit what can be reported or made available under this law. Nothing here blocks a state or federal civil lawsuit for wrongful disclosure of trade secrets. (2) For this section, a federal contractor (or its employee) given information under (e) counts as a federal employee. (g) Disclosure to foreign and multinational pesticide producers. (1) EPA generally can't knowingly disclose an applicant's or registrant's submitted information to anyone connected to a foreign or multinational pesticide business (or anyone who intends to pass it to one), unless the applicant or registrant consents. EPA must get a sworn statement from anyone who wants to inspect the data that they're not seeking it to deliver or sell it to such a business, and won't do so purposely or negligently. EPA can still disclose information in a public proceeding relevant to deciding whether a pesticide causes unreasonable adverse effects, subject to the law's other confidentiality rules. (2) EPA must keep records of who receives disclosed data under this subsection and who they represent, and must tell the applicant or registrant those names and affiliations. (3) The federal false-statements law (18 U.S.C. § 1001) applies to any sworn statement made under (1).

the actual law source: uscode.house.gov ↗public domain

(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.

If the Administrator proposes to release for inspection information which the applicant or registrant believes to be protected from disclosure under subsection (b), 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).

(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.

Source credit: (June 25, 1947, ch. 125, § 10, as added Pub. L. 92–516, § 2, Oct. 21, 1972, 86 Stat. 989; amended Pub. L. 95–396, § 15, Sept. 30, 1978, 92 Stat. 829; Pub. L. 98–620, title IV, § 402(4)(B), Nov. 8, 1984, 98 Stat. 3357; Pub. L. 100–532, title VIII, § 801(f), Oct. 25, 1988, 102 Stat. 2682; Pub. L. 102–237, title X, § 1006(b)(1), (2), (3)(J), Dec. 13, 1991, 105 Stat. 1895, 1896.)

history & why it existsrecord from the source credit

1947Enacted · Pub. L. 92-516 · 86 Stat. 989
1978Amended · Pub. L. 95-396 · 92 Stat. 829
1984Amended · Pub. L. 98-620 · 98 Stat. 3357
1988Amended · Pub. L. 100-532 · 102 Stat. 2682
1991Amended · Pub. L. 102-237 · 105 Stat. 1895, 1896

A history note hasn’t been published yet. The record shows enactment by Pub. L. 92-516 on 1947-06-25.

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