Enforcement consent agreements

Chemical exporters are potentially subject to Section 12(b) of TSCA. EPA s TSCA Section 12(b) export notification requirements apply to chemical substances or mixtures for which data are required under TSCA Section 5(b), an order has been issued under TSCA Section 5, a proposed or final rule has been issued under TSCA Sections 5 or 6, or an action is pending or relief has been granted under TSCA Sections 5 or 7. With regard to Section 4 of TSCA, only those chemical substances or mixtures listed in final TSCA Section 4 test rules and TSCA Section 4 Enforceable Consent Agreements are subject to the export notice requirements under TSCA Section 12(b). Notification of export is generally not required for articles, as provided by 40 CFR section 707.60(b). 

The US EPA has entered into enforceable consent agreements with some parties under the Toxic Substance Control Act to control PFOA in the environment. 

Federal Register. (1996, April 3). Requests for Proposals for Enforceable Consent Agreements Dermal Absorption Rate Testing of 80 OHSA Chemicals Solicitation of Interested Parties Text of Protocol, Vol. 61, No. 65. 

As a practical matter, the EPA takes a very long time to promulgate a test rule. For example, the EPA issued a test rule covering 34 chemicals that the Occupational Safety and Health Administration (OSHA) was concerned about because of skin absorption. That rule was effective May 26, 2004. However, OSHA had first sent a list of chemicals to the ITC in 1991, with a request that the ITC review the data available concerning skin absorption. The ITC first designated 84 of those chemicals in 1993. The EPA issued PAIR and TSCA 8(d) rules in 1993, 1994, and 1995, and subsequently entered into a voluntary enforceable consent agreement for testing one chemical. EPA proposed the test rule in 1999 and finalized it five years later. 

Enforceable Consent Agreements and Voluntary Testing Agreements... 

EPA has announced that is negotiating an enforceable consent agreement to obtain biodegradation and environmental fate testing for decabromodi-phenyl ether. EPA had requested this information under the VCCEP, but had not received any commitment to conduct the testing. ... 

Fluoropolymer and fluorotelomer testing information and information on enforceable consent agreements concerning them is available on the EPA Web site at http //www.epa.g0v/oppt/pfoa/pubs/pfoainfo.html pfos... 

Section 4 The US EPA may require manufacturers, importers, and processors to test chemicals when risks or exposures of concern are identified. This requires a formal rule making alternatively, the US EPA has worked with industry to develop data through Enforceable Consent Agreements (ECAs) and Voluntary Testing Agreements (VTAs) [20]. 

In at least one respect, the EPA s statements about when export notifications are mandatory are inconsistent with a court s statements. EPA has said that the 12(b) notification requirements apply not only to persons who sign a final testing consent agreement under 4 or a consent order under 5, but also to any other person who intends to export any substance covered by those agreements or orders. The EPA often enters into Enforceable Consent Orders (ECAs) rather than carrying out the burdensome rulemaking process... 

FDA. FDA has therefore sought to obtain the equivalent in the form of stipulated agreements with companies that are filed in court as consent decrees and thus are fully enforceable as a requirement of law. 

FDA also has statutory authority to request the Department of Justice to seek a court injunction against continued violations of the law by a prescription drug manufacturer or distributor. FDA has had mixed results in attempting to obtain injunctions from the courts, who realise that an injunction can shut down a company entirely or subject it to arbitrary demands by FDA. FDA has therefore sought to obtain the equivalent in the form of stipulated agreements with companies that are filed in court as consent decrees and thus are fully enforceable as a requirement of law. 

---