§766.35. Reporting requirements.
40 C.F.R. § 766.35
Letters of intent, exemption applications, and protocols—
Letters of intent.
Persons who have manufactured or imported chemical substances listed under § 766.25 between January 1, 1984, and the effective date of this part are required to submit under § 790.45 of this chapter a letter of intent to test or an exemption application. These letters must be submitted no later than September 3, 1987.
Persons who commence manufacture, import or processing of a chemical substance listed under § 766.25 that has not been manufactured, imported or processed between January 1, 1984 and the effective date of this part must submit under § 790.45 of this chapter, within 60 days after the commencement of manufacture, import, or processing of the chemical substance, a letter of intent to test or an exemption application.
Persons who commence manufacture, import or processing of a chemical substance listed under § 766.25 between the effective date of this part and the end of the reimbursement period for that particular chemical substance produced by a specific process must submit under § 790.45 of this chapter, within 60 days after the commencement of manufacture, import or processing of the chemical substance, a letter of intent to test or an exemption application.
Protocols.
Each person who is manufacturing or processing a chemical substance listed in § 766.25 as of the effective date of this part who submits a notice of intent to test under § 766.35(a)(1) must submit a protocol for the test as follows:
The protocols for each chlorinated chemical substance produced by each process to be tested must be submitted to EPA no later than 12 months after the effective date of this part.
The protocol for each brominated chemical substance produced by each process to be tested must be submitted to EPA no later than 24 months after the effective date of this part except for the following chemicals.
(1) The deadline for submitting the protocols for tetrabromobisphenol-A (CAS No. 79-94-7); 2,4,6 tribromophenol (CAS. No. 118-79-6); decabromodiphenyloxide (CAS No. 1163-19-5); and 1,2-bis(tribromophenoxy)-ethane (CAS No. 37853-59-1) is January 31, 1991.
(2) The deadline for submitting protocols for octabromodiphenyloxide (CAS No. 32536-52-0) and allyl ether of tetrabromobisphenol-A (CAS No. 25327-89-3) is January 31, 1991.
(3) The deadline for submitting protocols for pentabromodiphenyloxide (CAS No. 32534-81-9) is February 6, 1995. The deadline for submitting tetrabromobisphenol-A-bisethoxylate (CAS No. 4126-45-2) is January 31, 1991.
(4) The deadline for submitting protocols for 3,4′,5-tribromosalicylanilide (CAS No. 87-10-5) is September 5, 1990.
For chemical substances produced by a specific process not manufactured or processed as of the effective date of this part, a person who begins manufacture and submits a notice of intent to test must submit protocols for the test as follows:
Except as noted for the submitter and substance specified in the following table, protocols for testing must be submitted 12 months after manufacture or importation begins for chlorinated chemical substances.
Protocols for testing must be submitted 24 months after manufacture begins for brominated chemical substances.
For persons who have been granted exemptions, waivers or exclusions from testing, protocols must be submitted 12 months after expiration of the exemption, waiver or exclusion for chlorinated chemical substances, and 24 months after expiration of the exemption, waiver or exclusion for brominated chemical substances.
Information that must be submitted to EPA.
Persons who manufacture or import a chemical substance listed under § 766.25 must report no later than October 5, 1987 or 90 days after the person first manufactures or imports the chemical substance, whichever is later, the results of all existing test data which show that chemical substance has been tested for the presence of HDDs/HDFs.
Any manufacturer or importer of a chemical substance listed in § 766.25 in possession of unpublished health and safety studies on HDDs/HDFs is required to submit copies of such studies to EPA no later than October 5, 1987 or 90 days after the person first manufactures or imports the chemical substance, whichever is later. The following provisions of part 716 of this chapter apply to submission of these studies: §§ 716.3, 716.10(a) (1) and (4); 716.20(a) (1), (2), (3), (4), (7), (8) and (10); 716.25; 716.30; 716.35(a) (1), (2), and (4) [if applicable]; 716.35 (b) and (c); 716.40 (a) and (b); 716.50; 716.55; and 716.60(a)(2).
No later than October 5, 1987 or 90 days after the person first manufactures or imports the substance listed in § 766.25, any manufacturer or importer of a chemical substance listed in § 766.25 must submit records required to be held under part 717 of this chapter on any HDDs/HDFs.
Test results.
Test results must be submitted to EPA not later than 270 days after EPA's transmission of comments or 180 days after a final protocol is submitted to EPA, whichever is shorter, except as noted for the submitters and substances specified in the following table:
For purposes of reporting test results to EPA, and for further reporting triggered by a positive test result under § 766.35(c), a positive test result is defined at § 766.3.
Reporting of test results must follow procedures set out in part 790 of this chapter, except as modified in this part.
Information required to be submitted to EPA after submission of a positive test result.
Any person who submits a positive test result for a specific chemical substance listed under § 766.25 must submit to EPA no later than 90 days after the date of submission of the positive test result the following:
A completed form (EPA 7710-51) for that chemical substance. The form and instructions are available online at http://www.epa.gov/oppt/chemtest/ereporting/index.html. One form must be submitted for each chemical substance for which a positive test result has been submitted.
Health and safety studies for the chemical substance for which a positive test result has been reported. The following provisions of part 716 of this chapter apply to submission of these studies: §§ 716.3; 716.10 (a) (1), (2), (3) and (4); 716.20; 716.25; 716.30; 716.35(a) (1), (2), and (4), [if applicable]; 716.35 (b) and (c); 716.40 (a) and (b); 716.50; 716.55; 716.60(a)(2).
Copies of records on the chemical substances required to be held under part 717 of this chapter.
If a positive test result on a chemical substance is received from one person but not from others, EPA may issue a notice in the Federal Register listing that chemical substance and requiring any person manufacturing, importing or processing that chemical substance who has not submitted a positive test result to submit the information required in Part II of EPA Form 7710-51. Such a notice will be published only if EPA needs additional process data to make a determination of unreasonable risk.
-(e) [Reserved]
Effective date.
The effective date of this final rule is July 6, 1987, except for paragraphs (a)(2)(i)(B) introductory text, (a)(2)(i)(B)(1), (a)(2)(i)(B)(2), (a)(2)(i)(B)(3), (a)(2)(i)(B)(4), the table in paragraph (a)(2)(ii)(A), and the table in paragraph (b)(4)(i) of this section.
The effective date for paragraph (a)(2)(i)(B) introductory text, (a)(2)(i)(B)(1), (a)(2)(i)(B)(2), and (a)(2)(i)(B)(4), is May 21, 1991. The effective date of paragraphs (a)(2)(i)(B)(3), and the table in paragraph (a)(2)(ii)(A) is September 29, 1995. The effective date of paragraph (b)(4)(i) introductory text is May 28, 1993, and the effective date of the entries in the table in paragraph (b)(4)(i) is shown in the effective dates column of the table.
The guidelines and other test methods cited in this rule are referenced as they exist on the effective date of the final rule.
Notes, amendments, and revision history
Amendments
[52 FR 21437, June 5, 1987, as amended at 56 FR 23229, May 21, 1991; 57 FR 24960, June 12, 1992; 58 FR 30991, May 28, 1993, 58 FR 34205, June 23, 1993; 59 FR 46356, Sept. 8, 1994; 60 FR 31922, June 19, 1995; 60 FR 50433, Sept. 29, 1995; 60 FR 56955, Nov. 13, 1995; 62 FR 35105, June 30, 1997; 78 FR 72829, Dec. 4, 2013]
Authority
Authority: 15 U.S.C. 2603 and 2607.
Source
Source: 52 FR 21437, June 5, 1987, unless otherwise noted.
Amendments
[52 FR 21437, June 5, 1987, as amended at 56 FR 23229, May 21, 1991; 57 FR 24960, June 12, 1992; 58 FR 30991, May 28, 1993, 58 FR 34205, June 23, 1993; 59 FR 46356, Sept. 8, 1994; 60 FR 31922, June 19, 1995; 60 FR 50433, Sept. 29, 1995; 60 FR 56955, Nov. 13, 1995; 62 FR 35105, June 30, 1997; 78 FR 72829, Dec. 4, 2013]