Code of Federal Regulations Title 40. Protection of Environment § 40.766.32 Exclusions and waivers

(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;

(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.