§ 711.30 - Confidentiality claims.

§ 711.30 Confidentiality claims.

Cross Reference

Link to an amendment published at 85 FR 20148, Apr. 9, 2020.

(a) Confidentiality claimsMaking confidentiality claims -

(1) Generally. Any person submitting information under this part may assert a

business

confidentiality claim for

the

that information at the time it is submitted, except for information described in paragraph (a)(2). Any such confidentiality claims must be

made

asserted at the time the information is submitted.

Confidentiality claims cannot be made when a response is left blank or designated as not known or reasonably ascertainable.

These claims will apply only to the information submitted with the claim.

New confidentiality claims, if appropriate, must be asserted with regard to information submitted during a different submission period. Guidance

Instructions for asserting confidentiality claims

is

are provided in the

instructions

document identified in § 711.35. Information claimed as confidential in accordance with this section will be treated and disclosed in accordance with the procedures in 40 CFR part 2 and section 14 of TSCA.

(

b(1) The submitter must submit with the report detailed written answers to the following questions

2)

Chemical identity. A person may assert a claim of confidentiality for the chemical identity of a specific chemical substance only if the identity of that chemical substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that chemical substance under this part. The following steps must be taken to assert a claim of confidentiality for the identity of a reportable chemical substance:

Exceptions. Confidentiality claims cannot be asserted:

(i) For chemical identities listed on the public portion of the TSCA Inventory;

(ii) For processing and use data elements required by § 711.15(b)(4)(i)(A), (B), and (C) and § 711.15(b)(4)(ii)(A), (B), (C), and (D); or

(iii) When a response is left blank or designated as “not known or reasonably ascertainable.”

(3) Substantiations. All confidentiality claims must be substantiated at time of submission, in accordance with the requirements in paragraphs (b), (c), and (d)(1) of this section, and must be signed and dated by an authorized official. Confidentiality claims for the following data elements are exempt from this substantiation requirement:

(i)

What harmful effects to your competitive position, if any, or to your supplier's competitive position, do you think would result from the identity of the chemical substance being disclosed in connection with reporting under this part? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the harmful effects?

(ii) How long should confidential treatment be given? Until a specific date, the occurrence of a specific event, or permanently? Why?

(iii) 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?

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

(v) Is the fact that the chemical substance is being manufactured (including imported) for a commercial purpose available to the public, for example in technical journals, libraries, or State, local, or Federal agency public files?

(vi) What measures have been taken to prevent undesired disclosure of the fact that the chemical substance is being manufactured (including imported) for a commercial purpose?

(vii) To what extent has the fact that this chemical substance is manufactured (including imported) for commercial purposes been revealed to others? What precautions have been taken regarding these disclosures? Have there been public disclosures or disclosures to competitors?

(viii) Does this particular chemical substance leave the site of manufacture (including import) in any form, e.g., as product, effluent, emission? If so, what measures have been taken to guard against the discovery of its identity?

(ix) If the chemical substance leaves the site in a product that is available to the public or your competitors, can the chemical substance be identified by analysis of the product?

(x) For what purpose do you manufacture (including import) the chemical substance?

(xi) Has EPA, another Federal agency, or any Federal court made any pertinent confidentiality determinations regarding this chemical substance? If so, please attach copies of such determinations.

(2)

Production volume information required pursuant to § 711.15(b)(3)(iii).

(ii) Joint submission information from the primary submitter, consisting of trade name and supplier identification required pursuant to § 711.15(b)(3)(i)(A) and (B).

(iii) Joint submission information from the secondary submitter, consisting of the percentage of formulation required pursuant to § 711.15(b)(3)(i)(A) and (B).

(iv) Information that is supplied in a petition submitted under § 711.6(b)(2)(iii) or § 711.10(d)(1)(ii) and that is described in section 14(c)(2) of TSCA.

(4) Marking information claimed as confidential in confidentiality substantiation documentation. If any of the information contained in the answers to the questions listed in

paragraph

paragraphs (b) and (

1

c) of this section is asserted to contain

confidential business information (CBI), the submitter

information that itself is considered to be confidential, you must clearly identify the information that is claimed confidential

by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.” (c) Site identity

.

(5) Certification statement for claims. An authorized official representing a person asserting a claim of confidentiality must certify that the submission complies with the requirements of this part by signing and dating the following certification statement:

“I certify that all claims for confidentiality asserted with this submission are true and correct, and all information submitted herein to substantiate such claims is true and correct. Any knowing and willful misrepresentation is subject to criminal penalty pursuant to 18 U.S.C. 1001. I further certify that: (1) I have taken reasonable measures to protect the confidentiality of the information; (2) I have determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (3) I have a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of my company; and (4) I have a reasonable basis to believe that the information is not readily discoverable through reverse engineering.”

(6) Company, site, and technical contact identity information. A submitter may assert a claim of confidentiality for a site

only if

, company, or technical contact identity to protect the link between that information and the reported chemical substance. Such claim may be asserted only when the linkage of

the site with

that information to a reportable chemical substance is confidential and not publicly available.

The following steps must be taken to

(7) Processing and use information. A submitter may assert a claim of confidentiality for

a site identity:

(1) The submitter must submit with the report detailed written answers to the following questions signed and dated by an authorized official:

(i) Has site information been linked with a chemical identity in any other Federal, State, or local reporting scheme? For example, is the chemical identity linked to a facility in a filing under the Emergency Planning and Community Right-to-Know Act (EPCRA) section 311, namely through a Material Safety Data Sheet (MSDS)? If so, identify all such schemes. Was the linkage claimed as confidential in any of these instances?

(ii) What harmful effect, if any, to your competitive position do you think would result from the identity of the site and the chemical substance being disclosed in connection with reporting under this part? How could a competitor use such information? Would the effects of disclosure be substantial? What is the

each data element required by § 711.15(b)(4)(i)(D), (E) and (F) and § 711.15(b)(4)(ii)(E), (F), and (G) to protect the link between that information and the reported chemical substance. Such claim may be asserted only when the linkage of that information to a reportable chemical substance is confidential and not publicly available.

(b) All confidentiality claims requiring substantiation at time of submission. For each data element (or information supplied in a petition submitted under § 711.6(b)(2)(iii)(A) or § 711.10(d)(1)(ii)(A)) that is claimed as confidential, you must submit with your report detailed written answers to the following questions:

(1) Will disclosure of the information claimed as confidential likely cause substantial harm to your business's competitive position? If you answered yes, describe the substantial harmful effects that would likely result to your competitive position if the information is disclosed, including but not limited to how a competitor could use such information, and the causal relationship between the disclosure and the harmful effects

?

.

(2)

If any of the information contained in the answers to the questions listed in paragraph (c)(1) of this section is asserted to contain CBI, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.” (d) Processing and use information. A submitter may assert a claim of confidentiality for each data element required by

To the extent your business has disclosed the information to others (both internally and externally), has your business taken precautions to protect the confidentiality of the disclosed information? If yes, please explain and identify the specific measures, including but not limited to internal controls, that your business has taken to protect the information claimed as confidential.

(3)

(i) Is any of the information claimed as confidential required to be publicly disclosed under any other Federal law? If yes, please explain.

(ii) Does any of the information claimed as confidential otherwise appear in any public documents, including (but not limited to) safety data sheets; advertising or promotional material; professional or trade publications; state, local, or Federal agency files; or any other media or publications available to the general public? If yes, please explain why the information should be treated as confidential.

(iii) Does any of the information claimed as confidential appear in one or more patents or patent applications? If yes, please provide the associated patent number or patent application number (or numbers) and explain why the information should be treated as confidential.

(4) Does any of the information that you are claiming as confidential constitute a trade secret? If yes, please explain how the information you are claiming as confidential constitutes a trade secret.

(5) Is the claim of confidentiality intended to last less than 10 years (see TSCA section 14(e)(1)(B))? If yes, please indicate the number of years (between 1-10 years) or the specific date after which the claim is withdrawn.

(6) Has EPA, another federal agency, or court made any confidentiality determination regarding information associated with this chemical substance? If yes, please provide the circumstances associated with the prior determination, whether the information was found to be entitled to confidential treatment, the entity that made the decision, and the date of the determination.

(c) Additional requirements for specific chemical identity. A person may assert a claim of confidentiality for the specific chemical identity of a chemical substance as described in § 711.15(b)(

4

3) of this part only if the

linkage of the information with a reportable

identity of that chemical substance is treated as confidential in the Master Inventory File as of the time the report is submitted for that chemical substance. Generic chemical identities and

not publicly available. The following steps must be taken to

accession numbers may not be claimed as confidential. To assert a claim of confidentiality for

each data element, individually, required by § 711.15(b)(4): (1) The submitter

the identity of a reportable chemical substance, you must submit with the report detailed written answers to the

following questions signed and dated by an authorized official: (i) Is the identified use of

questions from paragraph (b) of this section and to the following questions.

(1) Is this chemical substance publicly known

? For example, is information on the use available in advertisements or other marketing materials, professional journals or other similar materials, or in non-confidential mandatory or voluntary government filings or publications? Has your company ever provided use information on the chemical substance that was not claimed as confidential?

(ii) What harmful effect, if any, to your competitive position or to your customer's competitive position do you think would result from the information reported as required by § 711.15(b)(4) and the chemical substance being disclosed in connection with reporting under this part? How could a competitor use such information? Would the effects of disclosure be substantial? What is the causal relationship between the disclosure and the substantial harmful effects?

(2) If any of the information contained in the answers to the questions listed in paragraph (d)(1) of this section is asserted to contain CBI, the submitter must clearly identify the information that is claimed confidential by marking the specific information on each page with a label such as “confidential business information,” “proprietary,” or “trade secret.”

(e) No claim of confidentiality. If no claim of confidentiality is indicated on Form U submitted to EPA under this part; if Form U lacks the certification required by

(including by your competitors) to be in U.S. commerce? If yes, please explain why the specific chemical identity should still be afforded confidential status (e.g., the chemical substance is publicly known only as being distributed in commerce for research and development purposes, but no other information about the current commercial distribution of the chemical substance in the United States is publicly available). If no, please complete the certification statement:

I certify that on the date referenced, I searched the internet for the chemical substance identity (i.e., by both chemical substance name and CASRN). I did not find a reference to this chemical substance that would indicate that the chemical is being manufactured or imported by anyone for a commercial purpose in the United States. [provide date].

(2) Does this particular chemical substance leave the site of manufacture (including import) in any form, e.g., as a product, effluent, emission? If yes, please explain what measures have been taken to guard against the discovery of its identity.

(3) If the chemical substance leaves the site in a form that is available to the public or your competitors, can the chemical identity be readily discovered by analysis of the substance (e.g., product, effluent, emission), in light of existing technologies and any costs, difficulties, or limitations associated with such technologies? Please explain why or why not.

(4) Would disclosure of the specific chemical name release confidential process information? If yes, please explain.

(d) Special situations -

(1) Joint submissions. If a primary submitter asks a secondary submitter to provide information directly to EPA in a joint submission under § 711.15(b)(

1); if confidentiality claim substantiation required under paragraphs (b), (c), and (d) of this section is not submitted with Form U; or if the identity of a chemical substance listed on the non-confidential portion of the Master Inventory File is claimed as confidential, EPA may make the information available to the

3)(i)(A) and (B), only the primary submitter may assert a confidentiality claim for the data elements that it directly submits to EPA. The primary submitter must substantiate those claims that are not exempt under paragraph (a)(3)(ii) of this section. The secondary submitter is responsible for asserting all confidentiality claims for the data elements that it submits directly to EPA and for substantiating those claims that are not exempt under paragraph (a)(3)(iii) of this section.

(2) Petitions. If a petition submitted under § 711.6(b)(2)(iii)(A) or § 711.10(d)(1)(ii)(A) includes any information claimed as confidential, the petitioner must provide a version of the petition that redacts the information claimed as confidential.

(e) No claim of confidentiality. Information not claimed as confidential in accordance with the requirements of this section may be made public without further notice to the submitter.

[85 FR 20148, Apr. 9, 2020]