40 CFR 2.204 - Initial action by EPA office.
(a)Situations requiring action. This section prescribes procedures to be used by EPA offices in making initial determinations of whether business information is entitled to confidential treatment for reasons of business confidentiality. Action shall be taken under this section whenever an EPA office:
(1) Learns that it is responsible for responding to a request under 5 U.S.C. 552 for the release of business information; in such a case, the office shall issue an initial determination within the period specified in § 2.112;
(3) Determines that it is likely that EPA eventually will be requested to disclose the information at some future date and thus will have to determine whether the information is entitled to confidential treatment. In such a case this section's procedures should be initiated at the earliest practicable time, in order to increase the time available for preparation and submission of comments and for issuance of determinations, and to make easier the task of meeting response deadlines if a request for release of the information is later received under 5 U.S.C. 552.
(b)Previous confidentiality determination. The EPA office shall first ascertain whether there has been a previous determination, issued by a Federal court or by an EPA legal office acting under this subpart, holding that the information in question is entitled to confidential treatment for reasons of business confidentiality.
(1) If such a determination holds that the information is entitled to confidential treatment, the EPA Office shall furnish any person whose request for the information is pending under 5 U.S.C. 552 an initial determination (see § 2.111 and § 2.113) that the information has previously been determined to be entitled to confidential treatment, and that the request is therefore denied. The office shall furnish such person the appropriate case citation or EPA determination. If the EPA office believes that a previous determination which was issued by an EPA legal office may be improper or no longer valid, the office shall so inform the EPA legal office, which shall consider taking action under § 2.205(h).
(2) With respect to all information not known to be covered by such a previous determination, the EPA office shall take action under paragraph (c) of this section.
(c)Determining existence of business confidentiality claims.
(1) Whenever action under this paragraph is required by paragraph (b)(2) of this section, the EPA office shall examine the information and the office's records to determine which businesses, if any, are affected businesses (see § 2.201(d)), and to determine which businesses if any, have asserted business confidentiality claims which remain applicable to the information. If any business is found to have asserted an applicable claim, the office shall take action under paragraph (d) of this section with respect to each such claim.
(i) If the examination conducted under paragraph (c)(1) of this section discloses the existence of any business which, although it has not asserted a claim, might be expected to assert a claim if it knew EPA proposed to disclose the information, the EPA office shall contact a responsible official of each such business to learn whether the business asserts a claim covering the information. However, no such inquiry need be made to any business -
(A) Which failed to assert a claim covering the information when responding to an EPA request or demand, or supplying information on an EPA form, which contained the substance of the statements prescribed by § 2.203(a);
(B) Which otherwise failed to assert a claim covering the information after being informed by EPA that such failure could result in disclosure of the information to the public; or
(C) Which has otherwise waived or withdrawn a claim covering the information.
(ii) If a request for release of the information under 5 U.S.C. 552 is pending at the time inquiry is made under this paragraph (c)(2), the inquiry shall be made by telephone or equally prompt means, and the responsible official contacted shall be informed that any claim the business wishes to assert must be brought to the EPA office's attention no later than the close of business on the third working day after such inquiry.
(iii) A record shall be kept of the results of any inquiry under this paragraph (c)(2). If any business makes a claim covering the information, the EPA office shall take further action under paragraph (d) of this section.
(3) If, after the examination under paragraph (c)(1) of this section, and after any inquiry made under paragraph (c)(2) of this section, the EPA office knows of no claim covering the information and the time for response to any inquiry has passed, the information shall be treated for purposes of this subpart as not entitled to confidential treatment.
(d)Preliminary determination. Whenever action under this paragraph is required by paragraph (c)(1) or (2) of this section on any business's claim, the EPA Office shall make a determination with respect to each such claim. Each determination shall be made after consideration of the provisions of § 2.203, the applicable substantive criteria in § 2.208 or elsewhere in this subpart, and any previously-issued determinations under this subpart which are applicable.
(i) Furnish the notice of opportunity to submit comments prescribed by paragraph (e) of this section to each business which is known to have asserted an applicable claim and which has not previously been furnished such notice with regard to the information in question;
(ii) Furnish, to any person whose request for release of the information is pending under 5 U.S.C. 552, a determination (in accordance with § 2.113) that the information may be entitled to confidential treatment under this subpart and 5 U.S.C. 552(b)(4), that further inquiry by EPA pursuant to this subpart is required before a final determination on the request can be issued, that the person's request is therefore initially denied, and that after further inquiry a final determination will be issued by an EPA legal office; and
(iii) Refer the matter to the appropriate EPA legal office, furnishing the information required by paragraph (f) of this section after the time has elapsed for receipt of comments from the affected business.
(2) If, in connection with all applicable claims, the office determines that the information clearly is not entitled to confidential treatment, the office shall take the actions required by § 2.205(f). However, if a business has previously been furnished notice under § 2.205(f) with respect to the same information, no further notice need be furnished to that business. A copy of each notice furnished to a business under this paragraph (d)(2) and § 2.205(f) shall be forwarded promptly to the appropriate EPA legal office.
(e)Notice to affected businesses; opportunity to comment.
(1) Whenever required by paragraph (d)(1) of this section, the EPA office shall promptly furnish each business a written notice stating that EPA is determining under this subpart whether the information is entitled to confidential treatment, and affording the business an opportunity to comment. The notice shall be furnished by certified mail (return receipt requested), by personal delivery, or by other means which allows verification of the fact and date of receipt. The notice shall state the address of the office to which the business's comments shall be addressed (the EPA office furnishing the notice, unless the General Counsel has directed otherwise), the time allowed for comments, and the method for requesting a time extension under § 2.205(b)(2). The notice shall further state that EPA will construe a business's failure to furnish timely comments as a waiver of the business's claim.
(2) If action under this section is occasioned by a request for the information under 5 U.S.C. 552, the period for comments shall be 15 working days after the date of the business's receipt of the written notice. In other cases, the EPA office shall establish a reasonable period for comments (not less than 15 working days after the business's receipt of the written notice). The time period for comments shall be considered met if the business's comments are postmarked or hand delivered to the office designated in the notice by the date specified. In all cases, the notice shall call the business's attention to the provisions of § 2.205(b).
(3) At or about the time the written notice is furnished, the EPA office shall orally inform a responsible representative of the business (by telephone or otherwise) that the business should expect to receive the written notice, and shall request the business to contact the EPA office if the written notice has not been received within a few days, so that EPA may furnish a duplicate notice.
(i) The portions of the information which are alleged to be entitled to confidential treatment;
(iii) The purpose for which the information was furnished to EPA and the approximate date of submission, if known;
(iv) Whether a business confidentiality claim accompanied the information when it was received by EPA;
(v) Measures taken by the business to guard against undesired disclosure of the information to others;
(vi) The extent to which the information has been disclosed to others, and the precautions taken in connection therewith;
(vii) Pertinent confidentiality determinations, if any, by EPA or other Federal agencies, and a copy of any such determination, or reference to it, if available;
(viii) Whether the business asserts that disclosure of the information would be likely to result in substantial harmful effects on the business' competitive position, and if so, what those harmful effects would be, why they should be viewed as substantial, and an explanation of the causal relationship between disclosure and such harmful effects; and
(ix) Whether the business asserts that the information is voluntarily submitted information as defined in § 2.201(i), and if so, whether and why disclosure of the information would tend to lessen the availability to EPA of similar information in the future.
(5) To the extent that the EPA office already possesses the relevant facts, the notice need not solicit responses to the matters addressed in paragraphs (e)(4) (i) through (ix) of this section, although the notice shall request confirmation of EPA's understanding of such facts where appropriate.
(f)Materials to be furnished to EPA legal office. When a matter is referred to an EPA legal office under paragraph (d)(1) of this section, the EPA office taking action under this section shall forward promptly to the EPA legal office the following items:
(1) A copy of the information in question, or (where the quantity or form of the information makes forwarding a copy of the information impractical) representative samples, a description of the information, or both;
(2) A description of the circumstances and date of EPA's acquisition of the information;
(3) The name, address, and telephone number of the EPA employee(s) most familiar with the information;
(5) A copy of each applicable claim (or the record of the assertion of the claim), and a description of when and how each claim was asserted;
(7) A copy of any request for release of the information pending under 5 U.S.C. 552;
(9) The office's comments concerning the appropriate substantive criteria under this subpart, and information the office possesses concerning the information's entitlement to confidential treatment; and
(10) Copies of other correspondence or memoranda which pertain to the matter.
Title 40 published on 10-May-2017 04:28
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 40 CFR Part 2 after this date.
- 40 CFR 2.307 — Special Rules Governing Certain Information Obtained Under the Federal Insecticide, Fungicide and Rodenticide Act.
- 40 CFR 2.104 — Responses to Requests and Appeals.
- 40 CFR 89.7 — Treatment of Confidential Information.
- 40 CFR 2.210 — Nondisclosure for Reasons Other Than Business Confidentiality or Where Disclosure Is Prohibited by Other Statute.
- 40 CFR 40.155 — Availability of Information.
- 40 CFR 2.205 — Final Confidentiality Determination by EPA Legal Office.
- 40 CFR 2.208 — Substantive Criteria for Use in Confidentiality Determinations.
- 40 CFR 2.206 — Advance Confidentiality Determinations.
- 40 CFR 2.306 — Special Rules Governing Certain Information Obtained Under the Toxic Substances Control Act.
- 40 CFR 2.212 — Establishment of Control Offices for Categories of Business Information.
- 40 CFR 2.207 — Class Determinations.
- 40 CFR 2.301 — Special Rules Governing Certain Information Obtained Under the Clean Air Act.
- 40 CFR 174.9 — Confidential Business Information Claims for Plant-Incorporated Protectant Submissions.
- 40 CFR 2.308 — Special Rules Governing Certain Information Obtained Under the Federal Food, Drug and Cosmetic Act.
- 40 CFR 172.46 — Submission of a Notification.
- 40 CFR 90.4 — Treatment of Confidential Information.
- 40 CFR 91.7 — Treatment of Confidential Information.
- 40 CFR 2.213 — Designation by Business of Addressee for Notices and Inquiries.