Toxic Substance Control Act Information

FAQs

• What is a Premanufacture Notification?

  Laboratories are responsible for determining whether a substance you intend to import or manufacture is a “new” chemical substance as defined by TSCA (40 CFR 720.3).  Laboratories must submit a PreManufacture Notice (PMN) if you intend to manufacture any new chemical substance that is not on the TSCA inventory of otherwise excluded from notification.  Form EPA 7710-25 must be completed and submitted to the EPA for PMN. 

• What is a TSCA Inventory?

  Any chemical substance manufactured or processed in the United States is listed by either a specific chemical name or by a Chemical Abstract Service (CAS) number (if it’s identity is not confidential) by the EPA under Section 8(b) of TSCA) Prior to submitting a PMN, anyone who plans to manufacture or import a chemical substance must determine if said substance is already listed in the public TSCA Inventory.  If said substance is not listed in the public TSCA Inventory, a request should be submitted to the EPA to determine if it is listed in the confidential TSCA Inventory. 

• Why do I need to document adverse health reactions or environmental effects from chemicals?

  The documentation of previously unrecognized significant adverse health reactions or environmental effects from chemicals  The EPA requires individuals who become aware of allegations of significant adverse health reactions or environmental effects to chemical substances used in research to report them to their institutions TSCA coordinator. The TSCA coordinator will evaluate the allegation with the help of other professionals (such as an Occupational Physician) and report the allegation if appropriate to the EPA. All allegations made to supervisors or Principal Investigators should be submitted in writing to the TSCA Coordinator.  If, during the course of your research, you learn that a chemical substance presents a previously unknown substantial risk to human health or the environment, contact the TSCA Coordinator who will determine if this information needs to be submitted to the EPA. Any data that is published in a peer reviewed scientific journal does not have to be submitted to the EPA.
  
  Report all allegations of significant adverse health reactions or environmental effects from exposure to the substances handled in your laboratory to the TSCA Coordinator. 

• How do I ship or transfer chemicals that have little or no health and safety data?

  Transfer or shipment of newly synthesized or imported chemical substances for which limited environmental, health, or safety data exist, the EPA requires that individuals that either import or synthesis chemical in their laboratories, or obtain them from other laboratories, maintain control over them and ensure that individuals that they distribute these substances to understand the known health, safety and environmental risks associated with the substance. Whenever transferring an imported chemical or a chemical synthesized in your laboratory (for which little or no environmental, health, or safety is available) the following procedures must be followed:

   

  • Complete the Chemical Substance Transfer Form and Preliminary Health and Safety Information Sheet for the chemical substances to be transferred and provide both forms to the researcher receiving the substances. 
  • Maintain a copy of these documents in your laboratory's TSCA folder or binder. 

   

  When transferring chemical substances that have been imported or synthesized in your laboratory it is essential that the individual receiving the substance be informed that the substance can only be used for research purposes. Accompanying documents must convey whatever health, safety, and environmental risks are known to be associated with the substance.  

• What procedures do I follow for chemicals that have little or no health and safety data?

  When certain new or imported chemical substances are handled in the laboratory for research purposes and very limited environmental, health or safety data exist, the EPA requires the laboratory or institution to establish special procedures and precautions for handling these substances. The procedures required by the EPA and established at Duke University include the following:

   

  Training and Communication - all known risks associated with handling the chemical substance must be communicated to the individuals coming in contact with it. This information should be provided in writing. This information must also be communicated to individuals in other laboratories to whom the material is sent. Risk information may be disseminated using the Preliminary Health and Safety Information Sheet as well as with signage and container labeling. All individuals handling chemical substances for which limited or no health and safety data exist must be trained in laboratory chemical safety training. There is a link to an on-line version of this training in the left hand margin.

   

  Standard Operating Procedures - in addition to the standard procedures followed for handling all chemicals in laboratories (such as proper container labeling and storage, use of personal protective equipment, and proper housekeeping and personal hygiene) the additional laboratory safety procedures outlined in Duke University’s Laboratory Safety Manual – Section 2 Chemical Safety must be followed. These procedures are designed to minimize the exposure to these chemicals and are based on the assumption that they are highly acutely or chronically toxic.  

   

  Waste Disposal - treat all wastes containing the chemical substance as hazardous and dispose of them through Duke University's chemical hazardous waste program. Laboratory chemical waste management training is available on the web and is linked in the margin.  

   

  Please note that the EPA only allows these reduced set of procedures to be followed if the substance is used in small quantities solely for research and the research is performed under the direction of a technically qualified individual such as a Principal Investigator