[Title 40 CFR 720.85]
[Code of Federal Regulations (annual edition) - July 1, 1999 Edition]
[Title 40 - PROTECTION OF ENVIRONMENT]
[Chapter I - ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)]
[Subchapter R - TOXIC SUBSTANCES CONTROL ACT]
[Part 720 - PREMANUFACTURE NOTIFICATION]
[Subpart E - Confidentiality and Public Access to Information]
[Sec. 720.85 - Chemical identity.]
[From the U.S. Government Printing Office]


40PROTECTION OF ENVIRONMENT231999-07-011999-07-01false720.85Sec. 720.85PROTECTION OF ENVIRONMENTENVIRONMENTAL PROTECTION AGENCY (CONTINUED)TOXIC SUBSTANCES CONTROL ACTPREMANUFACTURE NOTIFICATIONConfidentiality and Public Access to Information
Sec. 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 Sec. 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 Sec. 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 uner 
Sec. 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

[[Page 115]]

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 
Sec. 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

[[Page 116]]

must also answer the questions in Sec. 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 Sec. 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 Sec. 720.25(b) to determine whether the particular 
chemical substance is included on the confidential Inventory.
    (iii) Upon receipt of a request described in Sec. 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.