EPA Requires Companies to Submit Records on Reported Health and Environmental Effects Caused by Chemical Being Considered for TSCA Risk Evaluation
In support of its mission to protect human health and the environment, the U.S. Environmental Protection Agency (EPA) is requiring chemical companies to submit records of significant adverse human health and environmental effects reported to have been caused by 4,4'-Methylene bis(2-chloroaniline) (MBOCA) (CASRN: 101-14-4), a chemical EPA announced on Dec. 14, 2023, it was planning to prioritize for risk evaluation under the Toxic Substances Control Act (TSCA). This is the first time in more than 30 years EPA is using its authority under section 8(c) of TSCA to gather health and environmental data on a chemical. EPA is anticipating that the data could help the Agency better understand suspected adverse health or environmental effects of the chemical and, in turn, improve the efficiency of the risk evaluation process.
MBOCA is used in the manufacturing and processing of rubbers, plastics, resins and other chemicals. EPA has classified MBOCA as a probable human carcinogen. MBOCA was included in the 2014 update to the TSCA Work Plan, which means it was selected by EPA to be on a list of chemicals for further assessment based on its hazards and potential risks of exposure. EPA recently initiated the statutory prioritization process of five chemicals for risk evaluation, including MBOCA, meaning that it is likely EPA will begin a risk evaluation on MBOCA in the next 9-12 months.
Under TSCA section 8(c), chemical companies must maintain records of reports about a chemical’s harm to human health or the environment. These harms, or “significant adverse reactions,” can include human health effects like cancer or environmental impacts like groundwater contamination. The recordkeeping requirement includes records of employee health-related effects reported to companies over the last 30 years, public reports of other health-related harm for the previous five years, and reports of harm related to animals, plants, and the environment for the past five years. EPA has the authority under TSCA section 8(c) to request copies of these records, as the Agency is doing now.
EPA may use its 8(c) authority to collect data on one or more of the other five chemicals undergoing prioritization in the coming months.
To assist respondents in appropriately fulfilling their reporting obligations under this action, EPA has prepared guidance on the specific TSCA section 8(c) Recordkeeping and Reporting Limitations and Exclusions as defined in the regulations, as well as Guidance on Submitting TSCA section 8(c) Records using the Agency’s online Central Data Exchange (CDX) system and a Quick Guide to CDX Submissions. EPA is also making available, for reference purposes, a historical document entitled Questions and Answers Concerning the TSCA Section 8(c) Rule, published by EPA in July of 1984.
Chemical manufacturers (including importers) and processors that have records of significant adverse reactions to human health or the environment reported to have been caused by MBOCA have 60 days following publication of the notice in the Federal Register to submit those records to EPA.