40 CFR § 720.85 - Chemical identity.

§ 720.85 Chemical identity.

(a) Claims applicable to the period prior to commencement of manufacture or import. (1)(i) A person who submits information to EPA under this part may assert a claim of confidentiality for the chemical identity of the new chemical substance. This claim will apply only to the period prior to the commencement of manufacture or import for commercial purposes. A submitter may assert this claim only if the submitter believes that public disclosure prior to commencement of manufacture or import of the fact that anyone intends to manufacture or import the specific chemical substance for commercial purposes would reveal confidential business information.

(ii) If the notice includes a health and safety study concerning the new chemical substance and if the claim for confidentiality with respect to the chemical identity is denied in accordance with § 720.90(c), EPA will deny a claim asserted under this paragraph.

(2) Any person who asserts a claim of confidentiality for chemical identity under this paragraph must provide one of the following items at the time the notice is submitted:

(i) The generic name which was accepted by EPA in the prenotice consultation conducted under paragraph (a)(3) of this section.

(ii) One generic name that is only as generic as necessary to protect the confidential chemical identity of the particular chemical substance. The name should reveal the specific chemical identity to the maximum extent possible. The generic name will be subject to EPA review and approval at the time a notice of commencement is submitted.

(3)

(i) Any person who intends to assert a claim of confidentiality for the chemical identity of a new chemical substance may seek a determination by EPA of an appropriate generic name for the substance before submitting a notice. For this purpose, the person should submit to EPA:

(A) The chemical identity of the substance.

(B) A proposed generic name(s) which in only as generic as necessary to protect the confidential chemical identity of the new chemical substance. The name(s) should reveal the chemical identity of the substance to the maximum extent possible.

(ii) Within 30 days, EPA will inform the submitter either that one of the proposed generic names is adequate or that none is adequate and further consultation is necessary.

(4) If a submitter claims chemical identity to be confidential under this paragraph, and if the submitter complies with paragraph (a)(2) of this section, EPA will issue for publication in the Federal Register notice described in § 720.70 the generic name proposed by the submitter or one agreed upon by EPA and the submitter.

(b) Claims applicable to the period after commencement of manufacture or import.

(1) Any claim of confidentiality under paragraph (a) of this section is applicable only until the substance is manufactured or imported for commercial purposes and becomes eligible for inclusion on the Inventory. To maintain the confidential status of the chemical identity when the substance is added to the Inventory, a submitter must reassert the confidentiality claim and substantiate the claim in the notice of commencement of manufacture required under § 720.102. A submitter may not claim the chemical indentity confidential for the period after commencement of manufacture or import unless the submitter claimed the chemical identity confidential for the period prior to commencement of manufacture or import under paragraph (a) of this section.

(2)

(i) A person who believes that public disclosure of the fact that anyone manfactures or imports the new chemical substance for commercial purposes would reveal confidential business information may assert a claim of confidentiality under this paragraph.

(ii) If the notice includes a health and safety study concerning the new chemical substance, and if the claim for confidentiality with respect to the chemical identity is denied in accordance with § 720.90(c), EPA will deny a claim asserted under this paragraph.

(3) Any person who asserts a confidentiality claim for chemical identity must:

(i) Comply with the requirements of paragraph (a)(3) of this section regarding submission of a generic name.

(ii) Agree that EPA may disclose to a person with a bona fide intent to manufacture or import the chemical substance the fact that the particular chemical substance is included on the confidential Inventory for purposes of notification under section 5(a)(1)(A) of the Act.

(iii) Have available for the particular chemical substance, and agree to furnish to EPA upon request:

(A) An elemental analysis.

(B) Either an X-ray diffraction pattern (for inorganic substances), a mass spectrum (for most other substances), or an infrared spectrum of the particular chemical substance, or if such data do not resolve uncertainties with respect to the identity of the chemical substance, additional or alternative spectra or other data to identify the chemical substance.

(iv) Provide a detailed written substantiation of the claim, by answering the following questions:

(A) What harmful effects to your competitive position, if any, do you think would result if EPA publishes on the Inventory the identity of the chemical substance? How could a competitor use such information given the fact that the identity of the substance otherwise would appear on the Inventory of chemical substances with no link between the substance and your company or industry? How substantial would the harmful effects of disclosure be? What is the casual relationship between the disclosure and the harmful effects?

(B) For what period of time should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?

(C) Has the chemical substance been patented? If so, have you granted licenses to others with respect to the patent as it applies to the chemical substance? If the chemical substance has been patented and therefore disclosed through the patent, why should it be treated as confidential for purposes of the Inventory?

(D) Has the identity of the chemical substance been kept confidential to the extent that your competitors do not know it is being manufactured on imported for a commercial purpose by anyone?

(E) Is the fact that someone is manufacturing or importing this chemical substance for commercial purposes available to the public, e.g., in technical journals or other publications; in libraries; or in State, local, or Federal agency public files?

(F) What measures have you taken to prevent undesired disclosure of the fact that you are manufacturing or importing this substance for a commercial purpose?

(G) To what extent has the fact that you are manufacturing or importing this chemical substance for a commercial purpose been disclosed to others? What precautions have you taken in regard to these disclosures? Has this information been disclosed to the public or to competitors?

(H) In what form does this particular chemical substance leave the site of manufacture, e.g., as part of a product; in an effluent or emission stream? If so, what measures have you taken to guard against discovery of its identity?

(I) If the chemical substance leaves the site of manufacture in a product that is available to either the public or your competitors, can they identify the substance by analyzing the product?

(J) For what purpose do you manufacture or import the substance?

(K) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, copies of such determinations must be included in the substantiation.

(L) If the notice includes a health and safety study concerning the new chemical substance, the submitter must also answer the questions in § 720.90(b)(2).

(4) If the submitter does not meet the requirements of this paragraph, EPA will deny the claim of confidentiality.

(5)

(i) EPA will publish a generic name on the public Inventory if:

(A) The submitter asserts a claim of confidentiality in accordance with this paragraph.

(B) No claim for confidentiality of the specific chemical identity as part of a health and safety study has been denied in accordance with part 2 of this title or § 720.90.

(ii) Publication of a generic name on the public Inventory does not create a category for purposes of the Inventory. Any person who has a bona fide intent to manufacture or import a chemical substance which is described by a generic name on the public Inventory may submit an inquiry to EPA under § 720.25(b) to determine whether the particular chemical substance is included on the confidential Inventory.

(iii) Upon receipt of a request described in § 720.25(b), EPA may require the submitter which originally asserted confidentiality for a chemical substance to submit to EPA the information listed in paragraph (b)(3)(iii) of this section.

(iv) Failure to submit any of the information required under paragraph (b)(3)(iii) of this section within ten days of a request by EPA under this paragraph is a waiver of the original submitter's confidentiality claim. In this event, EPA may place the specific chemical identity on the public Inventory without further notice to the original submitter.

(6) If a submitter asserts a claim of confidentiality under this paragraph, EPA will examine the generic chemical name proposed by the submitter.

(i) If EPA determines that the generic name proposed by the submitter is only as generic as necessary to protect the confidential identity of the particular chemical substance, EPA will place that generic name on the public Inventory.

(ii) If EPA determines that the generic name proposed by the submitter is more generic than necessary to protect the confidential identity, EPA will propose in writing, for review by the submitter, an alternative generic name that will reveal the chemical identity of the chemical substance to the maximum extent possible.

(iii) If the generic name proposed by EPA is acceptable to the submitter, EPA will place that generic name on the public Inventory.

(iv) If the generic name proposed by EPA is not acceptable to the submitter, the submitter must explain in detail why disclosure of that generic name would reveal confidential business information and propose another generic name which is only as generic as necessary to protect the confidential identity. If EPA does not receive a response from the submitter within 30 days after the submitter receives the proposed name, EPA will place EPA's chosen generic name on the public Inventory. If the submitter does provide the information requested, EPA will review the response. If the submitter's proposed generic name is acceptable, EPA will publish that generic name on the public Inventory. If the submitter's proposed generic name is not acceptable, EPA will notify the submitter of EPA's choice of a generic name. Thirty days after this notification, EPA will place the chosen generic name on the public Inventory.

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