Senate’s TSCA Reform Bill Would Affect Importers, Exporting, Etc.

According to a press release from Senator Lautenberg (D), S. 3209 “puts the burden on industry to prove the chemicals are safe in order to stay on the market.” This would be a critical change from TSCA, which places the burden on EPA to prove that a chemical is unsafe.

Highlights of this bill as introduced include the following:

Declaration Within One Year of Enactment

Within one year after its enactment, the bill would require one of two declarations to be submitted to EPA from each manufacturer or processor of a chemical substance distributed in commerce.

(If the declaration is not submitted, the chemical substance could be considered “new,” and subject to additional requirements. See below on new chemical substances.)

The “Declaration of Current Manufacturing or Processing” would include:

• the chemical identity and any special substance characteristics;
• the name and location of each facility under the control of the manufacturer (importer) or processor at which the chemical substance is manufactured or processed or from which the chemical substance is distributed in commerce;
• a list of health and safety studies relevant to the substance; and
• all other relevant information about the chemical substance that has not already been submitted to EPA, such as (1) its physical, chemical, and toxicological properties, (2) the annual production volume and known uses, and (3) the name and location of each facility to which the chemical substance is sent.

A “Declaration of Cessation of Manufacturing or Processing” would be submitted if manufacturing, processing, importing, or exporting of a chemical substance by a manufacturer or processor has ceased or would cease within 180 days after the cessation declaration is filed.

Updates and records. New, updated declarations would be required every three years, or immediately if there is new information regarding the toxic effect of the chemical substance. The bill would also require each manufacturer or processor of a chemical substance distributed in commerce to maintain records to support these declarations.

Prohibition on manufacturing, processing, distribution. Those in violation of these declaration and associated requirements could be ordered to stop manufacturing, processing, or distributing in commerce the chemical substance or any article containing the chemical substance.

“Priority List” for Safety Determinations

Not later than 18 months after enactment, the bill would require EPA to develop and publish a list of at least 300 chemical substances for which safety determinations would first be made by EPA. Once a safety determination for a chemical substance is made, the chemical substance would be removed from the Priority List. Chemical substances would be added to the Priority List periodically, to ensure the list would not be fewer than 300 at any given time, until all chemical substances distributed in commerce have had a safety determination.

No judicial review. A decision of whether to place a particular chemical substance on the list, or a response to a petition to place a particular chemical substance on the list, would not be subject to judicial review.

Safety Determinations

Burden of proof. Under the bill, manufacturers and processors of a chemical substance, at all times, would bear the burden of proving that the chemical substance meets the applicable safety standard. The bill would require EPA to determine, based on a risk assessment, if that burden has been met.

In the case of manufacturing or processing for export (either in whole or in part), the bill would require EPA to consider the risks the chemical substance would pose in the U.S., including those involving long-range transport, and those involving the import of articles and mixtures containing the chemical substance.

Initial submission to EPA. The bill would require manufacturers or processors to submit information to EPA to assist the agency in making its initial safety determination. For chemicals on the priority list, the initial submission would be required within 18 months of the date that EPA places a chemical on the list or, for new substances, on the date of the notice of intention to manufacture. The bill would require the initial submission to include:

• the minimum data set¹ for the chemical substance, or an update of the minimum data set if it was submitted during the preceding 30-month period in response to placement of the chemical substance on the priority list, and
• the submission and development by testing as necessary, all other information the EPA may require, and
• an indication of whether the chemical substance, including specific uses to be evaluated (and any proposed conditions on the specific uses), meet the safety standard.

The manufacturer or processor’s initial safety determination would be due by the earlier of the date that is 30 months after the date a chemical substance is placed on the priority list or 14 years after the date of enactment.

Grouped determination. The bill would allow EPA to permit one or more manufacturers and processors to submit this determination on behalf of a number of manufacturers and processors. However, all such manufacturers and processors would be liable for compliance.

Safety determination within 180 days. The bill would require EPA to make its safety determination for the chemical substance within 180 days from the date of filing.

Negative determination by EPA. If EPA makes a negative safety determination, the bill would prohibit the chemical substance, or any mixture or article containing that chemical substance, from being manufactured, processed, or distributed in commerce in the U.S. This prohibition would be effective immediately for any new chemical substance, or in one year for all other chemical substances.

Positive determinations by EPA. Positive safety determinations would take effect in one year, or immediately for a new chemical substance. After the effective date, no person (defined to include company) would be allowed to manufacture, process, or distribute in commerce the chemical substance, or any mixture or article containing the chemical substance, for any use or under a condition other than those specified in the safety determination.

Quality control orders. The bill would allow EPA to issue quality control orders to a manufacturer or processor that is manufacturing or processing in a manner that may present a substantial endangerment. Manufacturers or processors may request an exemption from such orders for a period of five years, if certain criteria are met.

Notification if EPA delay. If the EPA fails to determine whether the manufacturer or processor has met the safety standard within 180 days of its receipt of their submission, the bill would require each manufacturer or processor to notify the public, their employees, recognized bargaining agents, and each customer who purchased the chemical substance that the safety determination is pending.

Redeterminations. The bill would require EPA to initiate a redetermination of whether the manufacturers and processors of a chemical substance have established that it meets the safety standard under the following conditions (1) if new information raises a credible safety question, (2) upon receipt of a renewal submission, or (3) after 15 years from the date of the previous application. Any person could petition the EPA for a redetermination.

Renewal in 15 years. Renewal of the safety determination would generally occur every 15 years after the date of the previous submission.

Prohibitions. If the manufacturer and processor fail to meet their duties for a chemical substance, the bill would allow EPA to prohibit them from manufacturing, processing, or distributing in commerce the chemical substance, or any mixture or article containing it.

Expedited Filing of Minimum Data Set for Priority List, New Chemical Substances

The bill would require that the minimum data set be filed within 18 months of EPA placing a chemical substance on the Priority List, or for new chemical substances², before the date the notice of intent to manufacture or process is required.

New Chemical Substances

Unless exempt, the bill would not allow the manufacturing or processing of a “new chemical substance” unless notice of the intent to manufacture or process and any EPA-required test data has been submitted to EPA, and EPA has determined that the manufacturers and processors have established that the chemical substance meets the safety standard.

Definition. The bill would define the term “new chemical substance” to mean any chemical substance for which the manufacturer or processor of the substance has not submitted a declaration².

Notice and testing.The EPA would require a notice to be filed and certain testing to occur, as a prerequisite to EPA’s review of any new chemical substance and/or mixture for manufacturing or processing.

Additional basis for approval of use. In addition to the above, the bill would give EPA the authority to approve the use of a new chemical substance if it finds that it is not (and is not expected) to be:

• manufactured in a volume of more than 1 million pounds per year or released into the environment in a volume of more than 100,000 pounds per year;
• a known toxicant, carcinogen, mutagen, or endocrine disruptor;
• persistent and bioaccumulative;
• found in human blood, fluid, or tissues; or
• found in food, drinking water, ambient or indoor air, residential soil, or house dust (unless the chemical would be naturally present there).

If approved by the EPA, the manufacturer or processor would have to notify EPA that it has commenced manufacturing and/or processing within 30 days of beginning to do so. This notice would contain a (1) declaration, (2) the minimum dataset, and if applicable, (3) a statement that the chemical substance will meet the safety standard.

Certification required. Each submission required pursuant to this section or pursuant to a rule or order issued under this section, would be accompanied by a certification signed by a responsible official of the manufacturer or processor that the submission is accurate and includes all known material facts.

New Uses, Production Increases, Etc.

Existing chemical prior to safety determination. Under the bill, no person may manufacture or process an existing chemical substance for which the EPA has not made a safety determination (1) for a use that was not ongoing as of the date of enactment, (2) at a significantly increased volume above the level on the date of enactment, or (3) if the person had not previously manufactured or processed the chemical substance as of the date of enactment, unless a new or updated Declaration, as well as a notice of intent to manufacture or process, and any test data required by rule or order, has been submitted to EPA.

Existing chemical with safety determination. Under the bill, no person may manufacture or process an existing chemical substance for which the EPA has made a positive safety determination for a use, at a production volume, or in a manner other than as specified in the EPA’s safety determination unless the manufacturer or processor has submitted to EPA (1) a notice of intent to manufacture or process and (2) relevant updates to the minimum data set.

In both instances, the manufacturer or processor must prove that the chemical substance will meet, or will continue to meet, the safety standards for the allowed new uses, volumes, etc.

Certification required. Each submission required pursuant to this section or pursuant to a rule or order issued under this section, would be accompanied by a certification signed by a responsible official of the manufacturer or processor that the submission is accurate and includes all known material facts.

Reports and Records

Assist in EPA’s safety determination. The bill would authorize EPA to require, by rule or order, any person (company) that manufactures, processes, distributes in commerce (exports), uses, or disposes of a chemical substance to report by a specified date information about the chemical that would assist EPA in making its safety determination. The bill would also allow EPA to further specify or modify (by rule or order) the information that would be required to be submitted with a particular report to establish the chemical identity and special subject characteristics of the subject chemical substance.

Adverse events. Any person (defined to include company) that manufactures, processes or distributes in commerce any chemical substance or mixture would be required to maintain and submit to EPA records of significant adverse reactions to health or the environment, as determined by EPA by rule, alleged to have been caused by the substance or mixture. Any such records that relate to employee health would have to be retained for a period of 30 years. Other records of adverse reactions would be required to be maintained for five years.

Certification required. The bill would require each submission to EPA under this section, or pursuant to a rule or order issued under this section, to be accompanied by a certification signed by a responsible official of the manufacturer or processor that the submission is accurate and includes all known material facts.

Listing and electronic database. The bill would require EPA to compile, keep current, and publish, within 18 months of enactment, a list of each chemical substance that is manufactured or processed in the U.S. In addition, the bill would require EPA to establish an electronic database within one year of enactment for storing and sharing information relating to toxicity, use of, and exposure to chemical substances.

The bill also would require significant decisions made by EPA relating to the safety of a chemical substance to be made available to the public via the electronic database within 18 months of the date of enactment or not later than 90 days after the decision would be made by EPA.

Testing, Submission of Samples

The EPA could by rule or order require testing for any chemical substance or mixture for its health or environmental impact, and require the test results be submitted by a certain date. The rule or order would include standards for the development of test data, and the time period for testing. EPA may also prescribe the methodology to be used. It could also specify who would conduct the test; third party testing may be allowed.

EPA could also require that samples of any chemical substance or mixture be submitted.

Certification required. Each submission required pursuant to this section or pursuant to a rule or order issued under this section, would be accompanied by a certification signed by a responsible official of the manufacturer or processor that the submission is accurate and includes all known material facts.

Prohibition. If testing does not occur as directed, EPA could prohibit the manufacturer or processor from manufacturing, processing, or distributing in commerce the chemical substance, or any mixture or article containing the chemical substance.

Exemption. Persons subject to these requirements could apply for an exemption.

Imports

U.S. Customs and Border Protection could refuse entry for chemical substances, mixtures, or articles containing same that fail to comply with or are offered for entry in violation of any relevant rule or order.

Exports

Persons that export a chemical substance or mixture to a foreign country would be required to notify the EPA of such exportation not later than 30 days after export. EPA would notify the government of the foreign country of the availability of the data submitted to EPA. Similar notification would occur if EPA has ordered an action on the substance or mixture due to an imminent hazard.

Moreover, those who have reported such exports would also be required to report any change in the export status of the substance or mixture not later than 30 days after such change in status; the EPA would then provide an updated notice to foreign governments if certain criteria are met.

Definitions

The bill would expand the definition of a “chemical substance” to include any chemical substance contained in or formed into an article. It would similarly modify the definition of “mixture” to include any mixture contained in or formed into an article.

The definition of “new chemical substance” would be modified to mean any chemical substance for which the manufacturer or processor of the substance has not submitted a declaration.

In addition, the term “distribute in commerce” or “distribution in commerce” would be expanded to include exports or offers for export.

Civil and Criminal Penalties

The bill would increase the available penalties for a failure to comply with its requirements. Civil penalties would increase from $25,000 per violation to $37,500 per violation. Criminal penalties would increase from $25,000 to $50,000 per violation. Individuals that knowingly place another in imminent danger of death or serious injury by violating the bill’s requirements would be fined up to $250,000 and could face imprisonment of up to 15 years. Companies that knowingly place others in imminent danger could be fined up to $1 million.

Fees

The bill would allow EPA, by rule, to require the payment of a reasonable fee from any person required to submit data, in order to defray the cost of administering these requirements.

Requirements for PCBs

The bill would also establish new requirements for the treatment of polychlorinated biphenyls. These requirements would prescribe methods for their disposal, marking, instructions for processing, and manufacturing. The bill would prohibit the manufacturing, processing, distributing, or use of any PCB in any manner other than a totally enclosed manner (one that ensures that the exposure of humans or the environment to PCBs will be insignificant).

Alternative Green Chemistry Program

As part of its goal of reducing the use of unsafe chemicals, the bill would direct EPA to, within one year of enactment, establish a program to create market incentives for the development of safer alternatives to existing chemical substances that reduce or avoid the use and generation of hazardous substances.

Expedited review. The safer alternatives and green chemistry program would include an expedited review of new chemicals for which the manufacturer/processor has submitted an analysis indicating that they are a safer alternative for a particular use than existing chemicals used for the same purpose.

¹EPA would establish by rule, within one year of enactment, (1) the data that constitutes the “minimum data set,” (2) the requirement to submit such data set, and (3) requirements for updating the submission as needed. The rule could also provide for varied or tiered testing for different chemical substances, mixtures, or categories of same.

²This definition seems to also apply to truly new chemical substances (e.g. with a new molecular identity). The definition also seems to mean that if a manufacturer or a processor fails to submit a declaration for an existing chemical substance, it would be considered “new” and the requirements for “new chemical substances” would be triggered.

(See ITT’s Online Archives or 04/16/10 news, (Ref: 10041605), for BP summary of Lautenberg’s introduction of TSCA reform bill.

See ITT’s Online Archives or 01/04/10 news, (Ref: 10010415), for BP summary of EPA’s plans for “chemicals of concern.”

See ITT’s Online Archives or 12/14/09 news, (Ref: 09121430), for BP summary of Senate oversight hearing on TSCA reform.

See ITT’s Online Archives or 12/01/09 news, (Ref: 09120125), for BP summary of House Subcommittee hearing on TSCA reform.

See ITT's Online Archives or 10/16/09 news, (Ref: 09101625), for BP summary of Jackson outlining the six principles and action it is taking until TSCA reform occurs.)

Senator Lautenberg’s press release (dated 04/15/10) available at http://lautenberg.senate.gov/newsroom/record.cfm?id=323863&.

Senator Lautenberg’s summary of S. 3209 available at http://lautenberg.senate.gov/assets/SCA2010Summary.pdf.

Text of S. 3209 available at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:s3209is.txt.pdf.