new reporting process for co-manufacturers under TSCA CDR rule may catch some manufacturers off guard | Bergeson & Campbell, CP
One of the many changes to the Toxic Substance Control Act (TSCA) Chemical Data Reporting (CDR) rule, issued in the final April 9, 2020 is that in the 2020 cycle, the EPA changed the way contract manufacturing is to be reported. In this cycle, the EPA will not accept reports from the sole contract manufacturer in situations where one company contracts with another company (that is to say., a contract manufacturer) for the production of chemicals. As in the past, the EPA states in its final rule that if no report is filed, the contracting and producing companies will be held responsible if no report is made. In previous RDC cycles, the EPA accepted reports from either the contract manufacturer or the producer manufacturer (formerly called “contract”). In 2020, the EPA said in several forums that for the 2020 reference period, the EPA will only accept manufacturing details from actual producers, even if manufacturing has been contracted by another company. This change may come as a surprise, especially for producing companies who until now may not have declared under the CDR rule and instead relied on the contracting company to do so.
The EPA stated in the preamble to the CDR Final Rule that it had chosen to include two different reporting methodologies for a co-manufacturing situation, indicating that the methodologies are based on the desire to reduce the burden of declaration and maintain flexibility for both the contracting company and the producing company. The EPA noted that companies must work together to choose between methodologies for preparing their CDR methodologies. The two reporting methodologies, codified at 40 CFR Section 711.22 (c), are:
(1) The contracting company initiates the report required for this 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 main depositor. The contracting company must indicate on the report that this is a co-manufacture situation, inform the producing company and record the volume of co-manufactured production in the country as indicated in §711.15 (b) (3) and the processing and usage information set out in §711.15 (b) (4). Upon notification from the contracting company, the producing company must also record the production volume co-manufactured locally and complete the rest of the report as requested by e-CDRweb.
(2) After 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 provides information not known or reasonably verifiable by the producing company.
In both cases, the producing company (contract manufacturer) must provide the manufacturing details. There is no mechanism for the contracting company to submit the entire U form.