EPA Issues Final Rule to Require Electronic TSCA Reporting
The Environmental Protection Agency is issuing a final rule to require electronic reporting of information required by the Toxic Substances Control Act (TSCA). Effective March 4, EPA will only accept data, reports, and other information subject to TSCA Section 4 (including test rules and enforceable consent agreements), Section 8(a) (preliminary analysis information), and Section 8(d) (health and safety data) if they're submitted through the agency’s Central Data Exchange (CDX) and Chemical Information Submission System (CISS) tool. The rule also extends electronic submission to certain documents related to TSCA Section 5 premanufacture and significant new use notifications originally submitted before April 2010. “Data, reports, and other information not submitted in the manner required will not be considered by EPA to have met the filing requirements of those rules,” the final rule says.
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Electronic Submission for Documents Required by TSCA Sections 4, 5 and 8
According to EPA, electronic TSCA reporting will reduce errors through built-in validation procedures, and cut down on the cost and time for submitters to review, edit, and transmit data. EPA’s workload will be reduced as well, because fewer resources will be required to review, process, store, and retrieve data. Finally, the rule will increase the legal dependability of TSCA reports through electronic signatures, EPA said. EPA said documents for which the final rule requires electronic submission include the following:
TSCA Section 4: letters of intent to conduct testing (40 CFR 790.45), extension requests (40 CFR 790.50), modification requests (40 CFR 790.55), exemption requests (40 CFR 790.80 and 40 CFR 790.82), hearing requests (40 CFR 790.90), data required to be developed under rules at 40 CFR 799, and documents and correspondence related to ECAs negotiated pursuant to 40 CFR 790.
TSCA Section 5: notice of commencements (NOCs) and support documents related to TSCA Section 5 premanufacture and significant new use notices submitted prior to April 6, 2010. NOCs and support documents for Section 5 notices submitted after April 2010 are already required, but EPA’s final rule extends these requirements to cover NOCs and support documents related to Section 5 notices submitted before that date. The new requirements are effective for NOCs and support documents submitted beginning March 4.
TSCA Section 8(a). Form 7710-35, Manufacturer's Report--Preliminary Assessment Information, and Form 7710-51, Dioxins/Furans Report Form.
TSCA Section 8(d). Data, reports, and other documents required under the TSCA section 8(d) Health and Safety Data Reporting Rule at 40 CFR 716 and the Dibenzo-Para-Dioxins/Dibenzofurans Rule at 40 CFR 766. That includes submission of underlying data, preliminary reports of ongoing studies, additional copies of, requests for extension of time, and requests for withdrawal of a chemical substance from a rule.
Registration in CDX Required; Upcoming Webinar to Discuss CISS
The final rule requires submitters to register with EPA’s CDX, request access to the agency’s Chemical Safety and Pesticide Program (CSPP), and use the CISS tool to prepare a file for submission (except for Section 5 documents). Registration for CDX is (here), and an EPA user guide is (here). Users already registered with CDX can add CSPP to their current registration and use the CISS tool, EPA said. Although EPA is requiring submission of documents through CDX, certified mail and email will still be allowed for correspondence related to the submission.
EPA said it will hold a webinar for potential users to become familiar with the CISS tool before its release. The webinar will be recorded and available (here), EPA said. EPA will also conduct beta testing to allow submitters to become familiar with the CISS tool on their own and provide the agency with feedback, it said.