Plan Ahead for TSCA Chemical Data Reporting

The CDR submission periods are from June 1 to September 30 at 4-year intervals, beginning in 2016. The 2012 CDR submission period, in which 2011 manufacturing, processing, and use and 2010 production volume information was reported, ended August 13, 2012.

It has only been a little more than a year since the last reporting deadline for CDR under  TSCA, but there is no time like the present to get organized for 2016 reporting. Although the U.S. Environmental Protection Agency (EPA) included several changes in the 2012 reporting requirements, the agency delayed implementation of others until 2016, including:

  • Facilities that manufacture or import a chemical substance in production volumes of 25,000 pounds (lbs) or more during any calendar year since the last reporting year (2012) will need to report.
  • Manufacturers/importers will be required to provide the production volume for each year since the last reporting year.
  • The reporting threshold for processing and use will be 25,000 lbs.
  • The reporting threshold of 2,500 lbs will apply to chemical substances that are the subject of:
    • A rule proposed or promulgated under TSCA section 5(a)(2), Significant New Use Rules (SNUR), section 5(b)(4) , Chemicals of Concern List rules, or section 6, Actions—rules containing prohibitions/restrictions arising from unreasonable risk findings.
    • An order issued under TSCA section 5(e), Exposure-Based Policy: Criteria, or section 5(f) Rule of Order, or
    • Relief granted under a TSCA section 5 or 7, civil action, New Chemicals Program or Imminent Hazards, respectively.

For facilities that did not report in during the last cycle, there are two other important changes implemented in 2012. First, like many EPA reporting requirements, the CDR went digital via the agency’s e-CDRweb. This system requires that facilities first be registered in the Central Data Exchange (CDX) under the program “Submissions for Chemical Safety and Pesticide Programs (CSPP).” Facilities that are already registered on the CDX for electronic reporting under TSCA, Toxic Release Inventory (TRI), or Premanufacture Notices do not need to reregister.

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In addition, the EPA’s commitment to increasing transparency with regard to public access to chemical information resulted in a more rigorous process for claims of Confidential Business Information (CBI).
The CBI claims must meet specific criteria set forth under 40 CFR 2.208, Substantive criteria for use in confidentiality determinations. These criteria specifically state:

(a) The business has asserted a business confidentiality claim, which has not expired by its terms, nor been waived, nor withdrawn;

(b) The business has satisfactorily shown that it has taken reasonable measures to protect the confidentiality of the information, and that it intends to continue to take such measures;

(c) The information is not, and has not been, reasonably obtainable without the business’s consent by other persons (other than governmental bodies) by use of legitimate means (other than discovery based on a showing of special need in a judicial or quasi-judicial proceeding);

(d) No statute specifically requires disclosure of the information; and

(e) Either—

1) The business has satisfactorily shown that disclosure of the information is likely to cause substantial harm to the business’s competitive position; or

2) The information is voluntarily submitted information (see Sec. 2.201(i)), and its disclosure would be likely to impair the government’s ability to obtain necessary information in the future.

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This new approach to confidentiality under TSCA also included review of previously granted confidentiality claims and has resulted in many CBI declassifications. As of April 2013, the EPA had completed more than 15,700 of 22,483 new and existing CBI claims citing declassifications based on three primary factors:

1) TSCA CBI Voluntary Challenge;
2) Internal review of data generated from older IT systems, and
3) The release of CBI claims for chemical identity by submitters at the time of a TSCA section 5 Notice of Commencement of Manufacture.

The EPA plans to continue processing the remaining CBI claims with emphasis on the TSCA CBI Voluntary Challenge and on cases under TSCA section 8(e), which requires chemical manufacturers, importers, processors, and distributers to notify the EPA immediately if they obtain information that a chemical or chemical mixture presents a substantial risk of injury to health or the environment.