Details of House TSCA Reform Bill's Reporting, Safety Determinations for Chemicals

This summary highlights most of the provisions in H.R. 5820 as well a July 29 Committee hearing on the bill.

(H.R. 5820 was introduced on July 22, 2010. It parallels in many respects the Senate’s version of TSCA reform legislation, S. 3209, the “Safe Chemicals Act,” which was introduced in April. See ITT’s Online Archives or 07/23/10 and 04/27/10 news, 10072315 and 10042747, for BP summaries.)

Provisions Specific to Imports and Exports

Importers Would Have to Satisfy Major TSCA Requirements

The importer of any chemical substance, mixture, or article containing a chemical substance or mixture for distribution in commerce would be required to satisfy all of the provisions in sections 4, 5, 6, and 8 of TSCA as amended (“TSCA”), without regard to whether the chemical substance or mixture has been formed into or contained in an article prior to importation.

(Under H.R. 5820, section 4 of TSCA would cover testing and minimum data sets. Section 5 would cover manufacturing and processing notices, including new substances and uses, Section 6 would be on EPA Safety Standard Determinations and the Priority List, and Section 8 would cover reporting and recordkeeping, including declarations.)

Authority to Refuse Goods for TSCA Violations Would Expand

Any substance, mixture, or article that fails to comply with or is offered for entry in violation of any rule or order in effect under TSCA (instead of any rule and certain listed violations and orders of TSCA) would be refused entry in the customs territory of the U.S. by U.S. Customs and Border Protection (CBP).

Importer Would be Defined in TSCA

Under the bill, “importer” would be defined as any person who imports a chemical substance or mixture, or any article containing a chemical substance or mixture, for distribution in commerce.

(Note the definition of “manufacture” already encompasses “to import.”)

“Distributed in Commerce” Requirements Would Include Exporting

The definition of distributed in commerce would be amended to include “to export or offer for export a substance, mixture, or article, except for demonstrated use solely as a pesticide, food, food additive, drug, cosmetic, or device” in addition to selling, introducing into commerce, etc. Therefore, many of H.R. 5820’s requirements would apply to exports.

Deadlines Would be Added for Export Notifications, Reporting Changes

Persons that export a chemical substance or mixture to a foreign country would continue to be required to notify the EPA of such exportation, but H.R. 5820 would specify that this notification should be made not later than 30 days after export. In addition, EPA would notify the government of the foreign country regarding the export if it had received new data on the substance or mixture, had ordered conditions imposed on it, etc.

Those who had previously reported such exports would also be required to report any change in the information provided not later than 30 days after such a change.

Manufacturers and Processors Would Need to Submit Declarations to EPA

Mandatory for Substances, Discretionary for Mixtures

H.R. 5820 would require each manufacturer or processor of chemical substances distributed in commerce to submit either a “Declaration of Current Manufacturing or Processing” or a “Declaration of Permanent Cessation of Manufacturing or Processing” to the Environmental Protection Agency (EPA) for each chemical substance manufactured (imported) or processed.

In addition, EPA may require submission of such declarations from any manufacturer or processor of a mixture which EPA determines has substance characteristics different from the substance characteristics of the constituent chemical substances.

“Current Manufacturing Declaration” Would be Required, Containing Detailed Information

A Declaration of Current Manufacturing or Processing would be required no later than one year after enactment or one year after beginning to manufacture (import) or process a chemical substance, whichever is earlier. It would be required to include:

• chemical identity of the chemical substance or mixture;
• name and location of each facility under the control of the manufacturer or processor at which the chemical substance or mixture is manufactured, (imported) processed or distributed in commerce;
• the number of individuals exposed or who will be exposed to the substance or mixture in their places of employment and the duration of such exposure;
• a list of health and safety studies relevant to the chemical substance or mixture conducted by, for, or reasonably ascertainable by the manufacturer or processor;
• all other relevant information that has not already been submitted to EPA, such as: (i) its physical, chemical, and toxicological properties; (ii) the categories or proposed categories of intended use of each such substance/mixture; (ii) total amount of each substance/mixture manufactured (imported) or processed; (iii) description of resulting byproducts; (iv) exposure information; (v) etc.

Updates and records. Updated declarations would be required every three years, or immediately if there were significant new information available to or reasonably ascertainable by the manufacturer or processor regarding a physical, chemical, toxicological property or use of or exposure to the chemical substance or mixture, indicating a new potential adverse effect. Manufacturers and processors would also have to maintain records to support these declarations.

Penalties and prohibitions. Those who do not submit or update declarations could face penalties, conditions, or be ordered to stop manufacturing (importing), processing, or distributing in commerce the chemical substance or mixture or any article containing the chemical substance or mixture.

Certification of accuracy. The declarations would have to be accompanied by a certification signed by a responsible official that each statement in the submission is accurate, reliable, and includes all material facts known to, in the possession or control of or reasonably ascertainable by the manufacturer or processor.

Inclusion in public database. EPA would be required to compile, keep current, publish and enter into the public database it would be required to create (see below) the names of each chemical substance and mixture for which a declaration is received, which is manufactured (imported) or processed in the U.S.

Substance Without This Declaration Would be Considered New

Chemical substances for which the manufacturer or processor has not submitted a declaration, would be considered new substances and subject to stricter requirements.

“Cessation Declaration” Required if No Longer Manufacturing Substance

If a manufacturer or processor has permanently ceased manufacturing (importing) or processing a chemical substance or mixture, then a Declaration of Permanent Cessation of Manufacturing or Processing would be submitted instead. This declaration would have to be filed not later than 180 days after cessation is complete. Such a declaration could also be filed based on an intention to permanently cease manufacture (import) or processing, in which case cessation would have to be complete no later than 180 days after the cessation declaration is filed.

These declarations would also have to be accompanied by a certification of accuracy, and those who did not submit the declaration could be subject to penalties.

EPA Safety Standard Determinations for Chemical Substances, Mixtures

For each chemical substance or mixture listed on a “Priority List”, EPA would be required to determine whether the following safety standard has been met, taking into account the aggregate exposure to the chemical substance or mixture for all intended uses:

• Reasonable certainty of no harm -- that there is a reasonable certainty that no harm will result to public health, including to vulnerable populations; and
• Public welfare protected -- that the public welfare is protected.

EPA would also have to consider among other relevant factors, the lifecycle of the chemical substance or mixture and available information concerning the cumulative effects of exposure to chemical substances or mixtures, among other relevant factors. EPA would also have to consider whether any controls or conditions could be taken to meet the safety standard and whether intended uses that do not meet the safety standard are critical.

Burden of proof. Manufacturers and processors of chemical substances or mixtures would bear the burden of proving that the substance/mixture meets the safety standard.

(During the hearing on this bill, there was significant debate over the safety standard and the burden of proof. Some stated that the safety standard was impossibly high. Others expressed confusion over the burden of proof and whether the trade or EPA would provide the data on aggregate exposure, cumulative effects, etc.)

Effective for 15 years. The determinations made by EPA would remain in effect for 15 years.

Redeterminations. EPA would have to make redeterminations if new information raises a credible question as to whether the chemical substance or mixture continues to meet the safety standard or if a new use of a chemical substance or mixture were proposed.

Public database. EPA safety standard determinations would also be included in the public database, along with the list of allowed uses and any conditions on those uses (see below).

Would Start with Priority List Substances, Then Expand

On the date of enactment, EPA would be required to establish a “Priority List” of chemical substances for which safety standard determinations would be made by EPA.

Initial list would have 19 substances. The initial Priority List would include the following 19 chemical substances:

• Seven different phthalates¹
• Bisphenol A
• Formaldehyde
• N--Hexane
• Hexavalent chromium
• Methylene chloride
• Trichloroethylene
• Vinyl chloride
• Perchlorate
• Tetrachloroethylene
• Tris (1,3-dichloro-2-propyl) phosphate
• Tris (2-chloroethyl) phosphate
• Tris (2,3-dibromopropyl) phosphate

Additional substances would be listed. Not later than 12 months after enactment, EPA would have to update the Priority List to consist of no fewer than 300 chemical substances. Substances would then be added periodically so that the list would not have fewer than 300 at any given time. This would continue until all chemical substances manufactured (imported), processed or distributed in commerce have been listed at some point, have received a safety standard determination, or have been exempted from the requirement to receive a safety standard determination.

Criteria for listing. Substances would be listed at EPA’s discretion based on available scientific evidence and consideration of the hazard, exposure, relative risk, aggregate or cumulative exposure, use, volume of manufacture, toxicological properties, persistence, bioaccumulation, or other properties indicating risk.

Mixtures could be added. EPA would also be able to add mixtures to the Priority List based on available scientific evidence and the same considerations described above.

Removal from list. EPA would only remove a chemical substance (or mixture) from the Priority List after a safety standard determination is made for it.

Manufacturers and Processors Would Have to Submit "Minimum Data Sets" to EPA

Within one year of enactment, EPA would have to issue a rule requiring manufacturers and processors of chemical substances or mixtures to submit a “minimum data set” to help EPA in its safety standard determinations.

Data set. The minimum data set, which would be accompanied by a certification ensuring its accuracy, would include information on: chemical identity; substance characteristics; biological and environmental fate and transport; toxicological properties; volume manufactured, processed, or imported; intended uses; and exposures from all stages of the chemical substance or mixture’s lifecycle that are known or reasonably foreseeable to the party submitting the data set.

Staggered due dates. For existing chemical substances or mixtures, the minimum data set would be required the sooner of: (1) 18 months after EPA lists the it on the Priority List; or (2) if the chemical is produced in: (i) high volumes - 3 years after enactment; (ii) moderate volumes - 4 years after enactment; or (iii) low volumes - 5 years after enactment. (EPA would have to determine what would be considered high, moderate, and low volumes.)

Exemptions. Minimum data sets would not be required for safer, approved alternative chemical substances, for substances or mixtures subject to permanent cessation of manufacturing or processing declarations, and certain other exceptions.

Testing & more info. In addition, EPA would also be able to require testing, by rule or by order, for any chemical substance or mixture and the submission of the test results by a specified date, as necessary for making a safety standard determination (or to carry out any other provision of H.R. 5820). EPA could also require the submission of additional information beyond the minimum data set. Failure to submit such information or test data in the time specified would constitute grounds for determining that the substance or mixture does not meet the standard.

Due Date for EPA Safety Standard Determinations

EPA would have to determine within 30 months after publication of a chemical substance or mixture on the Priority List (or within 18 months for the original 19 substances) whether that chemical substance/mixture meets the safety standard.

Restrictions if EPA delay. If EPA fails to publish or renew a determination or publish a redetermination by the applicable deadline, it would publish notice of such failure in the Federal Register, identifying the reasons for the delay. EPA would also prohibit new manufacturers or processors or new uses from entering the market until the determination is published.

"Affirmative" EPA Safety Standard Determinations

A chemical substance or mixture determined by EPA to meet the safety standard (without imposition of conditions) would be able to be manufactured (imported), processed, and distributed in commerce for uses identified and included in the determination.

"Affirmative" EPA Safety Standard Determinations, with Conditions

Chemical substances or mixtures which require the imposition of conditions in order to meet the safety standard would have to meet the conditions 1 year after publication of the determination (or as quickly as feasible and in no case later than 3 years after such publication) in order to be manufactured (imported), processed, used for commercial purposes, distributed in commerce, or disposed of.

Such conditions could include: limits on the amount which may be manufactured (imported); prohibitions on particular uses; marking or labeling requirements; prohibitions on certain manufacturing methods; etc.

"Negative" EPA Safety Standard Determinations

If EPA determines that an existing chemical substance or mixture has not been proven to meet the safety standard, effective 1 year after publication of that negative determination (or as quickly as feasible and in no case later than 3 years after such publication), no person would be able to manufacture (import), process, use for commercial purposes or distribute in commerce the chemical substance or mixture.

Exemptions for Critical Uses

Five year exemptions from any restrictions on manufacture (import), processing, use, distribution in commerce, or disposal imposed by EPA in its safety standard determination could be requested and granted for a specific use by a manufacturer or processor if they provide evidence that the use is paramount to national security; restriction would significantly disrupt the national economy; the use is critical or essential; no feasible safer alternative is available; etc.

Requirements for New Substances and New Uses

Definitions

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

EPA would consider a use to be new if the chemical substance or mixture has already received a safety standard determination which did not include the use; or the proposed use will result in manufacturing or processing of the chemical substance or mixture at a significantly increased volume above that considered in the safety standard determination.

Restrictions

Unless exempt, no person would be able to: (i) manufacture (import) or process a new chemical substance or mixture or (ii) manufacture (import) or process any chemical substance or mixture for a use which EPA has determined is a new use, unless:

(i)noticeof intent to manufacture/process is submitted at least 90 days before such manufacture (import) or processing begins accompanied by the certification of accuracy; and the requirements for the submission of data (see below) have been met; and

(ii)EPA finds one of the following: (a) that the chemical substance/mixture meets the safety standard with or without conditions; or (b) the chemical substance or mixture continues to meet the safety standard for all intended uses including the new use, with or without conditions; or (c) that the new use is a critical use.

Submission of Data

The notice of intent to manufacture/process new chemical substances or mixtures and new uses would have to include the following new information and data:

• the minimum data set;
• the declaration; and
• a statement that the chemical substance or mixture is reasonably anticipated to meet (or continue to meet -- for new uses) the safety standard, and a justification for such statement.

SNURs. For any chemical substance subject to a Significant New Use Rule (SNUR) as of the date of enactment, the requirements of that rule would apply to all manufacturers and processors of the chemical substance whether or not EPA determines a use to be new under the bill, unless and until the chemical receives a safety standard determination and, if appropriate, conditions or prohibitions are imposed, after which the SNUR would cease to apply.

(See bill for information on submitting declarations for new uses when the chemical substance or mixture is not new but has not yet received a safety standard determination, in which case the declaration would have to be submitted within 6 months of initiating manufacture (import), processing, or distribution, for that use.)

Due Dates for EPA Safety Standard Determinations

Not later than 90 days after submission of a notice of intent to manufacture or process and submission of data, if required, EPA would be required to determine whether the new use is a critical use or whether a safety standard determination is required. Not later than 9 months after the date of such determination, EPA would complete any such required safety standard determination.

"Affirmative" EPA Safety Standard Determinations

If EPA determines that a new substance or mixture meets the safety standard, it could be manufactured (imported), processed, and distributed in commerce. If EPA determines that a new use meets the safety standard, it could be manufactured, processed, and distributed in commerce for the use identified in the safety standard determination.

"Affirmative" EPA Safety Standard Determinations, with Conditions

If EPA determines that conditions are required to meet the safety standard, new chemical substances or mixtures or new uses would have to meet those conditions in order to be manufactured, processed, and distributed in commerce. Such conditions could include: limits on the amount which may be manufactured (imported); prohibitions on particular uses; marking or labeling requirements; prohibitions on certain manufacturing methods; etc.

"Negative" EPA Safety Standard Determinations

For new chemical substances or mixtures, if EPA determines the safety standard is not met, no person would be able to manufacture (import), process, or distribute in commerce the new chemical substance or mixture. If EPA determines that the new use did not meet the safety standard, no person would be able to manufacture (import), process, use, or distribute in commerce the existing chemical substance or mixture for the new use.

(According to the House Energy and Commerce Committee these provisions of the bill were substantially revised from their previous draft version to increase workability and support innovation for new substances and new uses.)

Disclosures to Commercial Purchasers

One year after enactment, all manufacturers and processors of chemical substances and mixtures subject to the reporting and recordkeeping requirements of 15 USC 2607 would be required to provide a disclosure to all known commercial purchasers of their substances or mixtures. The disclosure, which would be provided with shipment or promptly thereafter and by request, would include: (1) the chemical identity(ies); (2) toxicological properties submitted to EPA; (3) list of health and safety studies submitted to EPA: and (4) any records of significant adverse reactions submitted to EPA. This disclosure would be accompanied by the certification of accuracy described above.

Expedited Conditions for Persistant, Bioaccumulative, Toxic Substances

No later than one year after enactment, EPA would have to establish criteria by rule to identify chemical substances and mixtures that are persistent, bioaccumulative, and toxic (PBT) or are degraded or metabolized into chemical substances that are PBT and for which there is documented evidence of exposure to humans or the environment.

EPA would have to publish a list of all such substances/mixtures six months after publication of the rule, and no more than 18 months later, impose conditions on their manufacture (import), processing, use, distribution in commerce, and disposal in order to achieve the greatest practicable reductions in exposure to the chemical substance or mixture.

Within one year after the effective date of such conditions, EPA would have to determine whether the chemical substance or mixture meets the safety standard with the conditions imposed, taking into account the residual risk posed by continued exposure to the chemical substance or mixture, and impose any further conditions necessary to ensure that the chemical substance or mixture meets the safety standard.

(H.R 5820 would not require manufacturers to submit a minimum data set for PBT substances or mixtures, unless requested by EPA; however a declaration would be required no later than 6 months after a substance/mixture is listed as a PBT.)

Imminent Hazard Orders

EPA would be able to issue orders (in addition to beginning civil actions to seize goods) if a substance, mixture, or article containing such substance or mixture presents an imminent and substantial danger to health or the environment. Such orders may include any requirements on the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or article containing it, as EPA determines necessary to protect health or the environment, including the conditions that may be imposed.

Inspections

H.R. 5820 would expand the EPA’s inspection authority under 15 USC 2610 by extending it to commercial facilities in which articles containing subject substances or mixtures are manufactured (imported), processed, stored or held.

Other Definitions

The bill would amend or add other definitions as follows:

Mixture. The definition of mixture would be amended to mean “any composition of two or more chemical substances if the composition does not occur in nature, and is not, in whole or in part, the result of a chemical reaction.” In addition, EPA would be able to determine different mixtures comprised of the same chemical substances to be the same mixture for purposes of TSCA as amended, if the substance characteristics of the mixtures are identical.

Chemical substance. The definition of chemical substance would be amended so that in addition to current criteria, a chemical substance would include any form of a substance determined by EPA to be a chemical substance. In addition, chemical substances would exclude any alcoholic beverage.

New chemical substance. The definition of new chemical substance would be amended to mean any chemical substance for which the manufacturer or processor of the substance has not submitted a declaration, except that, with respect to the first year after enactment, such term would not include a chemical substance distributed in commerce as of such date of enactment.

Manufacture. The definition of manufacture would be amended to mean (with new text marked in italics): to import into the customs territory of the U.S., to produce, or to manufacture, except for demonstrated use solely as a pesticide, food, food additive, drug, cosmetic, or device.

Distributed in commerce. In addition to selling, introducing into commerce, etc., “distributed in commerce” would be amended to also include: “exporting or offering for export a substance, mixture, or article, except for demonstrated use solely as a pesticide, food, food additive, drug, cosmetic, or device.”

(See H.R. 5820 for the amended definitions proposed for environment, health, and safety study and process. See the bill for new definitions for adverse effect, aggregate exposure, bioaccumulative, chemical identity, cumulative exposure, Federal agency, persistent, substance characteristic, toxic, toxicological property, use, and vulnerable population.)

Prohibited Acts

H.R. 5820 would completely revise the prohibited acts of 15 USC 2614 by amending current prohibited acts and adding new ones.

For example, instead of it being unlawful for any person to fail or refuse to comply with specific rules, orders or requirements under TSCA, it would be unlawful to fail or refuse to comply with any rule, order, prohibition, restriction, or other requirement imposed by TSCA, as amended by H.R. 5820.

In addition, the following prohibited acts would be added so that it would be unlawful to:

False declarations - make or submit a statement, declaration, disclosure, certification, data set, or any oral, written, or electronic representation that is materially false, or to conceal any material fact.

Non-compliant labeling - introduce or deliver for introduction into commerce or knowingly distribute in commerce a chemical substance or mixture, or an article containing a chemical substance or mixture: (i) that lacks or fails to comply in any material respect with any applicable labeling requirements imposed pursuant to section 6(c); or (ii) the label, labeling or advertising of which is misleading in any material respect, including by reason of representations, either explicit or implicit, that the chemical substance or mixture is available for a use other than an intended use.

Forged marks - forge, counterfeit, simulate, falsely represent, or use without proper authority any mark, stamp, tag, label, or other identification device authorized or required by TSCA (as amended by H.R. 5820) or by EPA.

Penalties and Fees

The bill would expand the civil and criminal penalties of 15 USC 2615 so that penalties could be imposed for any violation of TSCA, as amended, instead of for certain listed violations. Furthermore, it would increase those penalties.

Civil penalties would increase from no more than $25,000 for each day of violation to no more than $37,500 for each day of violation. Criminal penalties would increase from no more than $25,000 for each day of violation to no more than $50,000 for each day of violation. In addition, individuals who knowingly or willfully violate any of TSCA’s requirements and who know that such violation may result in imminent danger of death or serious bodily injury could face a fine up to $250,000 or imprisonment up to 15 years, or both. Companies that do so would face fines up to $1 million.

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.

Safer Alternatives and Green Chemistry

Not later than one year after enactment, the bill would require EPA to establish a program to create incentives for the development of safer alternatives to existing chemical substances and mixtures that reduce or avoid the use and generation of hazardous chemical substances or mixtures.

Public Disclosure of Information

Not later than one year after enactment, H.R. 5820 would require EPA to establish a database that would be searchable, downloadable and publically accessible on the Internet. No later than five years after enactment, this database would have to include a list of all chemical substances and mixtures manufactured (imported), processed, or distributed in commerce in the U.S. EPA would also have to include information on the toxicity, use, and exposure to chemical substances and mixtures as well as any significant EPA decisions regarding the substances/mixtures and any significant adverse reactions.

¹Benzylbutyl phthalate; Dibutyl phthalate; Diethylhexyl phthalate; Di-isodecyl phthalate;

Di-isononyl phthalate; Di-n-hexyl phthalate; and Di-n-octyl phthalate.

(See ITT’s Online Archives or 07/29/10 news, 10072945, for BP summary of Representative Whitfield, Ranking Member of the Subcommittee on Commerce, Trade, and Consumer Protection saying that TSCA reform legislation might have to wait until the next Congress.

See ITT’s Online Archives or 07/27/10 news, 10072726, for BP summary of an Energy and Commerce Committee overview of the bill.

See ITT’s Online Archives or 07/26/10 news, 10072606, for BP summary of NAM speaking out against the bill.)