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New Reporting Procedure For Co-Manufacturers Under TSCA CDR Rule May Catch Certain Manufacturers Off Guard
One of several changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) rule, issued in final on April 9, 2020, is that in the 2020 cycle, EPA has changed the way that toll manufacturing must be reported. In this cycle, EPA will not accept reporting from only the contracting manufacturer in situations where a company contracts with another company (i.e., a toll manufacturer) for the production of chemicals. As in years’ past, EPA states in its final rule that if no report is filed, both the contracting and producing companies will be held liable if no reporting occurs. Under past CDR cycles, EPA would accept reporting from either the contracting manufacturer or the producing (formerly referred to as “toll”) manufacturer. In 2020, EPA has stated in multiple fora that for the 2020 reporting period, EPA will only accept manufacturing details from the actual producers, even if manufacturing was contracted by another company. This change may come as a surprise, especially to producing companies that heretofore may not have reported under the CDR rule and instead relied on the contracting company to do so.
EPA stated in the preamble to the final CDR rule that it chose to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on a desire to reduce reporting burden and maintain flexibility for both the contracting and producing company. EPA noted that the companies must work together to select between the methodologies for preparing their CDR methodologies. The two methodologies for reporting, codified at 40 C.F.R. Section 711.22(c), are:
(1) The contracting company initiates the required report for that site [defined by EPA at 40 C.F.R. §711.3 as the location where the chemical substance is physically manufactured for chemical substances co-manufactured] as the primary submitter. The contracting company must indicate on the report that this is a co-manufacturing situation, notify the producing company, and record the production volume domestically co-manufactured as set forth in §711.15(b)(3) and processing and use information set forth in §711.15(b)(4). Upon notification by the contracting company, the producing company must also record the production volume domestically co-manufactured and complete the rest of the report as prompted by e-CDRweb.
(2) Upon written agreement between the contracting company and the producing company, the producing company completes the full report for the co-manufactured chemical. The contracting company supplies the information not otherwise known to or reasonably ascertainable by the producing company.
In both cases, the producing company (toll manufacturer) must provide the manufacturing details. There is no mechanism for the contracting company to submit the entire Form U.
More information on the final CDR rule is available in our March 19, 2020, memorandum, “EPA Releases Final Amendments to CDR Rule, Extends Reporting Period.”