rigorous packaging that will withstand rough handling and contain all liquid material within the package without leakage to the outside,

   appropriate labeling of the package to alert the workers in the transportation chain to the hazardous contents within,

   documentation of the hazardous contents within the package and emergency contact information in the event of an emergency with the package, and

   training of workers in the transportation chain to familiarize them with the hazardous contents so as to be able to respond to emergency situations.

DOT is the national authority that regulates the shipment and transport of hazardous material. DOT regulations governing hazardous materials transport are detailed in Title 49 of the Code of Federal Regulations, Parts 171–178.

Technical Instructions for the Safe Transport of Dangerous Goods by Air, published by the International Civil Aviation Organization (ICAO), are the legally binding international regulations. Annually, the International Air Transport Association (IATA) publishes Dangerous Goods Regulations (DGR) that incorporates the ICAO provisions and may add further restrictions. The ICAO rules apply on all international flights. For national flights (i.e., flights within one country), national civil aviation authorities apply national legislation. This is normally based on the ICAO provisions, but may incorporate variations. State and operator variations are published in the ICAO Technical Instructions and in the IATA DGR.

11.F.2 EPA Requirements for Chemical Export and Import

TSCA, administered by EPA, was established 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 the Federal Insecticide, Fungicide, and Rodenticide Act; tobacco and tobacco products regulated by the Bureau of Alcohol, Tobacco, Firearms, and Explosives; radioactive materials regulated by the USNRC; and foods, food additives, drugs, and cosmetics or devices regulated by the Food and Drug Administration.

11.F.2.1 TSCA Research and Development Exemption

TSCA includes a “Research and Development (R&D) Exemption” which greatly reduces requirements for laboratories, but does not eliminate them. Under the R&D Exemption, laboratory chemicals are exempted from many TSCA requirements if they are

   imported, manufactured, or used in small quantities (“not greater than reasonably necessary for such (R&D) purposes”); and

   solely for purposes of noncommercial scientific experimentation, analysis, or research, and

   under the supervision of a technically qualified individual.

To maintain this exemption status, laboratories engaged in R&D must keep records of allegations of adverse reactions and discovery of substantial risk. Also, chemical imports need to be certified in writing, and certain chemical exports require notification of the receiving countries.

11.F.2.2 TSCA Record-Keeping Requirements for R&D Laboratories

For R&D laboratories, TSCA is primarily an administrative, records-intensive program. Establish a TSCA compliance file to log significant adverse effects, file reports of substantial risks, and document imports and exports.

Under TSCA § 8(c), laboratories are required to keep records of allegations of significant adverse effects from R&D chemicals. For example, laboratories must create and maintain records of allegations of, for example, a skin rash, allergic reaction, or respiratory effect that may be attributable to exposure to an R&D chemical.

Laboratories must also document the discovery of any significant risks to human health or the environment potentially associated with R&D substances. Include this report in your TSCA compliance file.

Your file should also contain TSCA import and export certifications, as described below. Copies of the written notifications provided (i.e., the letter, the MSDS, and copies of all labels affixed to sample containers) should be maintained in a file for 5 years.

11.F.2.3 Chemical Exports from R&D Laboratories

Laboratories must complete and send to EPA a TSCA Export Notification Form prior to the exportation of chemical substances listed in the EPA’s Chemicals on Reporting Rule (CORR) Database. Sample forms, the CORR Database, and EPA submission instructions



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