Code of Federal Regulations Title 40. Protection of Environment § 40.82.182 Confidentiality of data

(a) Clean Air Act provisions. Anyone submitting information must assert a claim of confidentiality at the time of submission for any data they wish to have treated as confidential business information (CBI) under 40 CFR part 2, subpart B. Failure to assert a claim of confidentiality at the time of submission may result in disclosure of the information by the Agency without further notice to the submitter. The submitter should also be aware that under section 114(c), emissions data may not be claimed as confidential.

(b) Substantiation of confidentiality claims. At the time of submission, EPA requires substantiation of any confidentiality claims made. Failure to provide any substantiation may result in disclosure of information without further notice by the Agency. All submissions must include adequate substantiation in order for an acceptability determination on a substitute to be published. Moreover, under 40 CFR part 2, subpart B, there are further instances in which confidentiality assertions may later be reviewed even when confidentiality claims are initially received. The submitter will also be contacted as part of such an evaluation process.

(c) Confidentiality provisions for toxicity data. In the event that toxicity or health and safety studies are listed as confidential, this information cannot be maintained as confidential where such data are also submitted under TSCA or FIFRA, to the extent that confidential treatment is prohibited under those statutes. However, information contained in a toxicity study that is not health and safety data and is not relevant to the effects of a substance on human health and the environment (e.g., discussion of process information, proprietary blends) can be maintained as confidential subject to 40 CFR part 2, subpart B.

(d) Joint submissions under other statutes. Information submitted as part of a joint submission to either SNAP/TSCA or SNAP/FIFRA must adhere to the security provisions of the program offices implementing these statutes. For such submissions, the SNAP handling of such notices will follow the security provisions under these statutes.