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been provided or obtained under sec (2) "Contaminant” means any physition 13 of the Act, if it was provided in cal, chemical, biological, or radiologiresponse to a request by EPA made for cal substance or matter in water. the purpose of enabling EPA to deter- (3) “Proceeding" means any rulemine whether the manufacturer has making, adjudication, or licensing acted or is acting in compliance with process conducted by EPA under the the Act, or if its submission could have Act or under regulations which implebeen required under section 13 of the ment the Act, except for any determiAct, regardless of whether section 13 nation under this part. was cited as authority for the request, (b) Applicability. (1) This section apwhether an order to provide such in plies only to informationformation was issued under section (i) Which was provided to or ob11(d) of the Act, 42 U.S.C. 4910(d), and tained by EPA pursuant to a requirewhether the information was provided ment of a regulation which was issued directly to EPA by the manufacturer by EPA under the Act for the purpose or through some third person.

of(c) Basic rules which apply without (A) Assisting the Administrator in change. Sections 2.201 through 2.207 establishing regulations under the Act; and $ $ 2.209 through 2.215 apply with (B) Determining whether the person out change to information to which providing the information has acted or this section applies.

is acting in compliance with the Act; (d) (Reserved)

or (e) Substantive criteria for use in (C) Administering any program of ficonfidentiality determinations. Sec- nancial assistance under the Act; and tion 2.208 applies without change to (ii) Which was provided by a information to which this section ap person plies; however, no information to (A) Who is a supplier of water, as dewhich this section applies is voluntar- fined in section 1401(5) of the Act, 42 ily submitted information.

U.S.C. 300f(5); (f) (Reserved)

(B) Who is or may be subject to a (g) Disclosure of information rele

primary drinking water regulation vant to a proceeding. (1) Under section under section 1412 of the Act, 42 13 of the Act, any information to U.S.C. 300g-1; which this section applies may be re

(C) Who is or may be subject to an leased by EPA because of its relevance

applicable underground injection conto a matter in controversy in a pro

trol program, as defined in section ceeding, notwithstanding the fact that

1422(d) of the Act, 42 U.S.C.300h-1(d); the information otherwise might be (D) Who is or may be subject to the entitled to confidential treatment

permit requirements of section 1424(b) under this subpart. Release of infor

of the Act, 42 U.S.C. 300h-3(b); mation because of its relevance to a

(E) Who is or may be subject to an proceeding shall be made only in ac

order issued under section 1441(c) of cordance with this paragraph (g).

the Act, 42 U.S.C. 300j(c); or (2)-(4) The provisions of

(F) Who is a grantee, as defined in $ 2.301(g)(2), (g)(3), and (g)(4) are in

section 1445(e) of the Act, 42 U.S.C. corporated by reference as paragraphs

300j-4(e). (g)(2), (g)(3), and (g)(4), respectively,

(2) This section applies to any inforof this section.

mation which is described by para

graph (b)(1) of this section if it was (41 FR 36902, Sept. 1, 1976, as amended at provided in response to a request by 43 FR 40003, Sept. 8, 1978)

EPA or its authorized representative $ 2.304 Special rules governing certain in

(or by a State agency administering formation obtained under the Safe

any program under the Act) made for Drinking Water Act.

any purpose stated in paragraph (b)(1)

of this section, or if its submission (a) Definitions. For the purposes of could have been required under secthis section:

tion 1445 of the Act, 42 U.S.C. 3000-4, (1) “Act" means the Safe Drinking regardless of whether such section was Water Act, 42 U.S.C. 300f et seq.

cited in any request for the informa.

only in accordance with paragraph (h)(2) or (h)(3) of this section.

(2)-(3) The provisions of $ 2.301 (h)(2) and (h)(3) are incorporated by reference as paragraphs (h)(2) and (h)(3), respectively, of this section. (41 FR 36902, Sept. 1, 1976, as amended at 43 FR 40003, Sept. 8, 1978]

tion, or whether the information was provided directly to EPA or through some third person.

(c) Basic rules which apply without change. Sections 2.201 through 2.207, $ 2.209, and $8 2.211 through 2.215 apply without change to information to which this section applies.

(d) (Reserved)

(e) Substantive criteria for use in confidentiality determinations. Section 2.208 applies to information to which this section applies, except that information which deals with the existence, absence, or level of contaminants in drinking water is not eligible for confidential treatment. No information to which this section applies is voluntarily submitted information.

(f) Nondisclosure for reasons other than business confidentiality or where disclosure is prohibited by other statute. Section 2.210 applies to information to which this section applies, except that information which deals with the existence, absence, or level of contaminants in drinking water shall be available to the public notwithstanding any other provision of this part.

(g) Disclosure of information relevant to a proceeding. (1) Under section 1445(d) of the Act, any information to which this section applies may be released by EPA because of the relevance of the information to a proceeding, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Release of information to which this section applies because of its relevance to a proceeding shall be made only in accordance with this paragraph (g).

(2)-(4) The provisions of $ 2.301(g)(2), (g)(3), (g)(4) are incorporated by reference as paragraphs (g)(2), (g)(3), and (g)(4), respectively, of this section.

(h) Disclosure to authorized representatives. (1) Under section 1445(d) of the Act, EPA possesses authority to disclose to any authorized representative of the United States any information to which this section applies, notwithstanding the fact that the information otherwise might be entitled to confidential treatment under this subpart. Such authority may be exercised

8 2.305 Special rules governing certain in

formation obtained under the Solid Waste Disposal Act as amended by the Resource Conservation and Recovery

Act of 1976. (a) Definitions. For purposes of this section:

(1) "Act" means the Solid Waste Disposal Act as amended by the Resource Conservation and Recovery Act of 1976, 42 U.S.C. 6901 et seq.

(2) “Person" has the meaning given it in section 1004(15) of the Act, 42 U.S.C. 6903(15).

(3) “Hazardous waste" has the meaning given it in section 1004(5) of the Act, 42 U.S.C. 6903(5).

(4) “Proceeding" means any rulemaking, adjudication, or licensing conducted by EPA under the Act or under regulations which implement the Act, except for determinations under this part.

(b) Applicability. This section applies only to information provided to or obtained by EPA under section 3007 of the Act, 42 U.S.C. 6927, by or from any person who generates, stores, treats, transports, disposes of, or otherwise handles hazardous wastes. Information will be considered to have been provided or obtained under section 3007 of the Act if it was provided in response to a request from EPA made for any of the purposes stated in section 3007, or if its submission could have been required under section 3007, regardless of whether section 3007 was cited as the authority for any request for the information or whether the information was provided directly to EPA or through some third person.

(c) Basic rules which apply without change. Sections 2.201 through 2.207 and $ $ 2.209 through 2.215 apply without change to information to which this section applies.

(d) (Reserved)

(e) Substantive criteria for use in (3) (i) “Health and safety data": confidentiality determinations. Sec- means the information described in tion 2.208 applies without change to paragraphs (a)(3)(i)(A), (a)(3)(i)(B), information to which this section ap and (a)(3)(i)(C) of this section with replies; however, no information to spect to any chemical substance or which this section applies is voluntar mixture offered for commercial distriily submitted information.

bution (including for test marketing (f) [Reserved)

purposes and for use in research and (g) Disclosure of information rele development), any chemical substance vant in a proceeding. (1) Under sec included on the inventory of chemical tion 3007(b) of the Act (42 U.S.C. substances under section 8 of the Act 6927(b)), any information to which (15 U.S.C. 2607), or any chemical subthis section applies may be disclosed stance or mixture for which testing is by EPA because of the relevance of required under section 4 of the Act (15 the information in a proceeding under U.S.C. 2603) or for which notification the Act, notwithstanding the fact that is required under section 5 of the Act the information otherwise might be (15 U.S.C. 2604). entitled to confidential treatment . (A) Any study of any effect of a under this subpart. Disclosure of in- chemical substance or mixture on formation to which this section ap- health, on the environment, or on plies because of its relevance in a pro- both, including underlying data and ceeding shall be made only in accord epidemiological studies; studies of ocance with this paragraph (g).

cupational exposure to a chemical sub(2)-(4) The provisions of $ 2.301 stance or mixture; and toxicological, (g)(2), (g)(3), and (g)(4) are incorporat- clinical, and ecological studies of a ed by reference as paragraphs (g)(2), chemical substance or mixture; (g)(3), and (g)(4), respectively, of this (B) Any test performed under the section.

Act; and (h) Disclosure to authorized repre (C) Any data reported to, or othersentatives. (1) Under section 3007(b) of wise obtained by, EPA from a study the Act (42 U.S.C. 6927(b)), EPA pos described in paragraph (a)(3)(i)(A) of sesses authority to disclose to any au- this section or a test described in parathorized representative of the United graph (a)(3)(i)(B) of this section. States any information to which this (ii) Notwithstanding paragraph section applies, notwithstanding the (a)(3)(i) of this section, no information fact that the information might other shall be considered to be “health and wise be entitled to confidential treat safety data" if disclosure of the informent under this subpart. Such author- mation wouldity may be exercised only in accord (A) In the case of a chemical subance with paragraph (h)(2) or (h)(3) of stance or mixture, disclose processes this section.

used in the manufacturing or process(2)-(3) The provisions of $ 2.301 ing the chemical substance or mixture (h)(2) and (h)(3) are incorporated by or, reference as paragraphs (h)(2) and

(B) In the case of a mixture, disclose (h)(3), respectively, of this section.

the portion of the mixture comprised

by any of the chemical substances in (43 FR 40003, Sept. 8, 1978)

the mixture. $ 2.306 Special rules governing certain in

(4) (Reserved]

(5) "Mixture" has the meaning given formation obtained under the Toxic

it in section 3(8) of the Act, 15 U.S.C. Substances Control Act.

2602(8). (a) Definitions. For the purposes of (6) "Proceeding" means any rulethis section:

making, adjudication, or licensing con(1) “Act" means the Toxic Sub ducted by EPA under the Act or under stances Control Act, 15 U.S.C. 2601 et regulations which implement the Act, seg.

except for determinations under this (2) "Chemical substance" has the subpart. meaning given it in section 3(2) of the (b) Applicability. This section apAct, 15 U.S.C. 2602(2).

plies to all information submitted to

EPA for the purpose of satisfying wirtten notice (or on such later date as some requirement or condition of the is established in lieu thereof under Act or of regulations which implement paragraph (f)(3) of this section), the Act, including information origi unless the EPA legal office has first nally submitted to EPA for some other been notified of the business' compurpose and either relied upon to mencement of an action in a Federal avoid some requirement or condition court to obtain judicial review of the of the Act or incorporated into a sub determination and to obtain prelimimission in order to satisfy some re nary injunctive relief against discloquirement or condition of the Act or sure."; and of regulations which implement the (4) Notwithstanding $ 2.205(g), the Act. Information will be considered to 31 calendar day period prescribed by have been provided under the Act if $ 2.205(f)(2), as modified by paragraph the information could have been ob- (e)(3) of this section, shall not be tained under authority of the Act, shortened without the consent of the whether the Act was cited as authority business. or not, and whether the information (f) (Reserved) was provided directly to EPA or (g) Substantive criteria for use in through some third person.

confidentiality determinations. Sec(c) Basic rules which apply without tion 2.208 applies without change to change. Sections 2.201 through 2.203, information to which this section ap$ 2.206, § 2.207, and $ $ 2.210 through plies, except that health and safety 2.215 apply without change to infor data are not eligible for confidential mation to which this section applies. treatment. No information to which

(d) Initial action by EPA office. Sec- this section applies is voluntarily subtion 2.204 applies to information to mitted information. which this section applies, except that (h) Disclosure in special circumthe provisions of paragraph (e)(3) of stances. Section 2.209 applies to inforthis section regarding the time allowed mation to which this section applies, for seeking judicial review shall be re- except that the following two addiflected in any notice furnished to a tional provisions apply to $ 2.209(c): business under $ 2.204(d)(2).

(1) The official purpose for which (e) Final confidentiality determina- the information is needed must be in tion by EPA legal office. Section 2.205 connection with the agency's duties applies to information to which this under any law for protection of health section applies, except that,

or the environment or for specific law (1) Notwithstanding $ 2.205(i), the enforcement purposes; and General Counsel (or his designee), (2) EPA notifies the other agency rather than the regional counsel, shall that the information was acquired make the determinations and take the under authority of the Act and that actions required by $ 2.205;

any knowing disclosure of the infor(2) In addition to the statement pre- mation may subject the officers and scribed by the second sentence of employees of the other agency to the § 2.205(f)(2), the notice of denial of a penalties in section 14(d) of the Act business confidentiality claim shall (15 U.S.C. 2613(d)). state that under section 20(a) of the (1) Disclosure of information releAct, 15 U.S.C. 2619, the business may vant in a proceeding. (1) Under seccommence an action in an appropriate tion 14(a)(4) of the Act (15 U.S.C. Federal district court to prevent dis 2613(a)(4)), any information to which closure.

this section applies may be disclosed (3) The following sentence is substi- by EPA when the information is reletuted for the third sentence of vant in a proceeding under the Act, $ 2.205(f)(2): “With respect to EPA's notwithstanding the fact that the inimplementation of the determination, formation otherwise might be entitled the notice shall state that (subject to to confidential treatment under this $ 2.210) EPA will make the informa subpart. However, any such disclosure tion available to the public on the shall be made in a manner that prethirty-first (31st) calendar day after serves the confidentiality of the inforthe date of the business' receipt of the mation to the extent practicable without impairing the proceeding. Disclo- disclosure is necessary to protect sure of information to which this sec- health or the environment against an tion applies because of its relevance in unreasonable risk of injury to health a proceeding shall be made only in ac or the environment. However, any discordance with this paragraph (i).

closure shall be made in a manner (2)-(4) The provisions of that preserves the confidentiality of $ $ 2.301(g)(2), (g)(3), and (g)(4) are in the information to the extent not incorporated by reference as paragraphs consistent with protecting health or (i)(2), (i)(3), and (i)(4), respectively, of the environment against the unreasonthis section.

able risk of injury. Disclosure of infor(j) Disclosure of information to con mation to which this section applies tractors and subcontractors. (1) Under

because of the need to protect health section 14(a)(2) of the Act (15 U.S.C.

or the environment against an unrea2613(a)(2)), any information to which sonable risk of injury shall be made this section applies may be disclosed

only in accordance with this paraby EPA to a contractor or subcontrac

graph (k). tor of the United States performing

(2) If any EPA office determines work under the Act, notwithstanding

that there is an unreasonable risk of the fact that the information other

injury to health or the environment wise might be entitled to confidential

and that to protect health or the envi. treatment under this subpart. Subject to the limitations in this paragraph

ronment against the unreasonable risk (j), information to which this section

of injury it is necessary to disclose in

formation to which this section apapplies may be disclosed to a contrac

plies that otherwise might be entitled tor or subcontractor if the EPA pro

to confidential treatment under this gram office managing the contract or

subpart, the EPA office shall notify subcontract, or (in the case of contractors or subcontractors with agencies

the General Counsel in writing of the other than EPA) the General Counsel,

nature of the unreasonable risk of determines in writing that such disclo

injury, the extent of the disclosure sure is necessary for the satisfactory

proposed, how the proposed disclosure performance by the contractor or sub

will serve to protect health or the encontractor of the contract or subcon

vironment against the unreasonable tract.

risk of injury, and the proposed date (2)-(4) The provisions of $$ 2.301

of disclosure. Such notification shall (h)(2)(ii), (h)(2)(iii), and (h)(2)(iv) are

be made as soon as practicable after incorporated by reference as para

discovery of the unreasonable risk of graphs (j)(2), (j)(3), and (j)(4), respec

injury. If the EPA office determines tively, of this section.

that the risk of injury is so imminent (5) At the time any information is

that it is impracticable to furnish writfurnished to a contractor or subcon

ten notification to the General Countractor under this paragraph (i), the sel, the EPA office shall notify the EPA office furnishing the information

General Counsel orally. to the contractor or subcontractor (3) Upon receipt of notification shall notify the contractor or subcon- under paragraph (k)(2) of this section, tractor that the information was ac the General Counsel shall make a dequired under authority of the Act and termination in writing whether disclothat any knowing disclosure of the in sure of information to which this secformation may subject the contractor tion applies that otherwise might be or subcontractor and its employees to entitled to confidential treatment is the penalties in section 14(d) of the necessary to protect health or the enAct (15 U.S.C. 2613(d)).

vironment against an unreasonable (k) Disclosure of information when risk of injury. The General Counsel necessary to protect health or the envi. shall also determine the extent of disronment against an unreasonable risk closure necessary to protect against of injury. (1) Under section 14(a)(3) of the unreasonable risk of injury as well the Act (15 U.S.C 2613(a)(3)), any in- as when the disclosure must be made formation to which this section ap- to protect against the unreasonable plies may be disclosed by EPA when risk of injury.

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