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January 25, 2010

EPA Revises TSCA Section 8(e) CBI Policy and Holds ePMN CDX Registration Webinar

The ACTA Group

On January 21, 2010, the U.S. Environmental Protection Agency (EPA) announced a new practice concerning confidential business information (CBI) claims for substantial risk information submitted to EPA under Toxic Substances Control Act (TSCA) Section 8(e). 75 Fed. Reg. 3462. According to EPA’s announcement, if a chemical substance is listed on the public portion of the TSCA Inventory, EPA expects a company submitting a health and safety study to EPA under TSCA Section 8(e) for that chemical substance will not claim the chemical identity as confidential. According to EPA, “[t]his action is part of a broader effort to increase transparency and provide more valuable information to the public by identifying programs where non-CBI may have been claimed and treated as CBI in the past.” EPA also states that this Notice concerning EPA’s new general practice is not a final Agency action, but instead, any determination letter issued by EPA for a specific TSCA Section 8(e) submission finding that the chemical identity is not entitled to confidential treatment would be. If EPA is correct, judicial review of the new policy cannot be sought until EPA denies a submitter’s CBI claims. While EPA did not specifically solicit comments on its announcement, it opened docket number EPA-HQ-OPPT-2009-1013 for this matter (available online).

EPA Hosts Webinar on TSCA Section 5 CDX Registration

On January 21, 2010, EPA hosted a webinar concerning the registration process for use of EPA’s Central Data Exchange (CDX) to encrypt and submit electronically premanufacture notices (PMN) and other TSCA Section 5 notices and support documents to EPA. EPA published a final rule on January 6, 2010, revising TSCA Section 5 reporting requirements to require electronic submission (see our Revised Reporting Requirements memorandum — online). Slides from the webinar are available at the Office of Pollution Prevention and Toxics New Chemicals Program web page. EPA presenter Dr. Kathy Schechter stated that the audio portion of the webinar, as well as a Questions & Answers document based on the questions posed during the webinar, will be posted soon.

Beginning on April 6, 2010, new PMN and other TSCA Section 5 submissions must be prepared using EPA’s newly released ePMN software, which is currently available in non-encrypted form at the New Chemicals Program link above. The encrypted software is available for download following CDX registration and is required for an electronic CDX submission. Submissions also may be sent to EPA starting on April 6, 2010, through EPA’s CDX system. EPA is allowing a two-year transition period during which submissions may continue to be made in hard-copy (first year only) or on CD; by April 6, 2012, all submissions must be made electronically over the Internet via CDX. The webinar addressed the CDX registration process only. During the webinar, Schechter stated that another webinar concerning use of the new ePMN software will be held sometime in March 2010.

Any entity that wishes to submit a TSCA Section 5 notice or supporting information to EPA through the CDX system must first register to use that system. For TSCA Section 5 submissions, EPA has defined two categories of submitters or registrants, whose registration processes differ somewhat: (1) An Authorized Official may submit all documents related to a TSCA Section 5 submission; according to EPA, “Authorized Officials are those persons who would normally be listed at the top of PMN page 3 and sign the PMN form.” (2) A Support Registrant may submit only support documents such as amendments, test data, and correspondence; a Support Registrant is a person designated by an Authorized Official to submit the supporting information and may include consultants or other third parties. As only an Authorized Official may submit an initial PMN or other TSCA Section 5 submission, in effect electronic submission is the new equivalent of EPA’s prior requirement for an original signature on page 2 of the PMN form.

CDX registration is a multi-step process that involves both online and hard-copy steps and should be begun well before a company intends to submit a PMN. A company may have multiple registered Authorized Officials. A Support Registrant may only register after an Authorized Official has done so, as the registrations are connected, and must register separately for each Authorized Official registration. EPA has used its CDX system for a while for other online reporting, such as for the TSCA Inventory Update Rule; if a company previously has registered for other purposes, it must now register again for TSCA Section 5 submissions. One may register now online from any computer with Internet access online.

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We hope this information is helpful. As always, please call if you have any questions.