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Toxic Substances Control Act (TSCA) Fact
Sheet
This fact sheet is designed to provide University of Minnesota
laboratories with an overview of the requirements and impacts of Toxic
Substances Control Act (TSCA) with regards to new chemicals. More
specific guidance and resources are available on the EPA TSCA website [http://www.epa.gov/oppt/newchems].
Overview of TSCA
The Toxic Substances Control Act (TSCA), administered by the U.S.
Environmental Protection Agency (EPA), is intended to ensure that the
human health and environmental effects of chemical substances are
identified and properly controlled prior to placing these materials
into commerce.
Chemical substances regulated
by TSCA include: "Any organic or inorganic substances of a
particular molecular identity including any combination of such
substances occurring, in whole or in part, as a result of chemical
reaction or occurring in nature and any element or uncombined radical."
Chemical substances not regulated or
excluded by TSCA include:
- pesticides regulated by FIFRA
- tobacco and tobacco products regulated by ATF
- radioactive materials regulated by NRC
- foods, food additives, drugs, cosmetics or
devices regulated by FDA
Laboratories engaged in research must consider the applicability of the
Toxic Substances Control
Act (TSCA) to their operation. Most University of Minnesota
laboratory operations for which TSCA is applicable will fall under the
R&D Exemption.
Research and
Development (R&D) Exemption:
Any chemical substance is exempted from many
of the requirements of TSCA when it is imported, produced or used in
small quantities, and solely for purposes of non-commercial scientific
experimentation, analysis or research, and under the supervision of a
technically qualified individual.
To maintain this exemption status, laboratories engaged in research and
development must comply with the following TSCA requirements:
- Certify the TSCA status of imports of R&D
substances, in writing.
- Notify receiving countries of exports of
certain R&D substances, in writing.
- Document prudent laboratory practices.
- Label containers, shipping containers and
shipping papers of any substance shipped for R&D purposes with
language to that effect. Evaluate and communicate risks for any shipped
R&D substance by preparing and shipping an MSDS and/or transfer
form with the substance.
- Create and maintain records of any allegations
of effects to human health or the environment potentially caused by
R&D substances.
- Document and report any significant risks to
human health or the environment potentially associated with R&D
substances.
Note that chemical substances that do not meet this definition or
laboratories that do not meet the requirements of the R&D exemption
are subject to significant additional TSCA requirements. If you
suspect that your operation does not meet the R&D exemption; please
contact the DEHS office at 626-6002 for assistance.
To ensure that your department complies with TSCA’s regulatory
requirements, each department should complete the following steps:
Step 1: Determine
TSCA’s applicability to your department
Use the TSCA
Applicability Form to evaluate each research laboratory
operation and to document the results to the TSCA Coordinator. Laboratory operations should
be monitored on an on-going basis for any changes that could affect
your TSCA applicability. A new TSCA Applicability Form
should
be prepared whenever such changes take place.
Step 2: Identify a
“TSCA Coordinator” for your department
This person may be a department’s Research Safety Officer or another
technically qualified individual that will manage the department’s TSCA
requirements to ensure compliance. A person who is knowledgeable
in the following areas should act as TSCA Coordinator:
- How chemicals are procured and transferred
(e.g. direct purchase, import from foreign country, shipped to non-U of
MN facilities, etc.)
- The type and approximate quantity of chemicals
used in the department;
- The nature of the research and operations
conducted in the department;
- Grant and funding applications and contracts.
Step 3: Establish a
TSCA compliance file
TSCA is primarily an administrative,
records-intensive program. TSCA files will be the first stop
during an inspector’s visit. TSCA files should contain the
following documents:
- TSCA Applicability Form
- Lab Safety Plan documenting prudent practices
- Import certifications
- Export notifications
- Inter-facility shipping/transfer records
- Significant adverse effect log
- Substantial risk reports
Step 4: Develop a
process for ongoing review of TSCA applicability/compliance
Ensure that a process is in-place to conduct ongoing applicability
determination and documentation.
Resources Available
from Environmental Health and Safety:
- TSCA
Applicability Form
- TSCA
Transfer Document
- TSCA
Import Certification
- Exporting
Chemicals out of the US
-
TSCA export notification chemical list
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