(a) Reasons for exclusions and waivers. Any person subject to the testing requirements of this part may request an exclusion or waiver from testing for any one of the following reasons:
(1) Exclusions may be granted if.
(i) Testing of the appropriate grade of the chemical substance has already been carried out, either analytical testing at the lowest LOQ possible, with appropriate QA/QC, or a well-designed bioassay with appropriate QA/QC or;
(ii) Process and reaction conditions of the chemical substance such that no HDDs/HDFs could be produced under those conditions;
(2) Waivers may be granted if.
(i) A responsible company official certifies that the chemical substance is produced only in quantities of 100 kilograms or less per year, only for research and development purposes; or
(ii) In the judgement of EPA, the cost of testing would drive the chemical substance off the market, or prevent resumption of manufacture or import of the chemical substance, if it is not currently manufactured, and the chemical substance will be produced so that no unreasonable risk will occur due to its manufacture, import, processing, distribution, use, or disposal. (In this case, the manufacturer must submit to EPA all data supporting the determination.)
(iii) Waivers may be appropriately conditioned with respect to such factors as time and conditions of manufacture or use. The grade of decabromodiphenyl oxide produced by Dow Chemical Company (Dow) for the National Toxicology Program (NTP) bioassay on that chemical is excluded from the testing requirement under this part. Provided, however, that this exclusion will not apply if Dow fails to supply to EPA within 60 days of the effective date of this section evidence showing which grade was used for the NTP bioassay.
(b) Timing. Exclusion or waiver requests and detailed supporting data must be submitted to EPA within 60 days from the effective date of this part for persons manufacturing, importing or processing a chemical substance as of the date of promulgation, or 60 days prior to the date of resumption of manufacture or import for a chemical substance produced by a specific process if the chemical substance is not manufactured, imported or processed as of the date of promulgation.
(c) Publication. Within 10 days of receipt of any exclusion or waiver request, EPA will issue in the Federal Register a notice of such receipt. EPA will also issue a notice of its decision on each exclusion or waiver request within 60 days of receipt.
(d) Decision. The EPA Director of the Office of Pollution Prevention and Toxics will make the decision to grant or deny waivers or exclusions.