Summary and Comparison of the TSCA Reform Legislation
Bergeson & Campbell. P.C. is pleased to provide the summary and comparison of the Toxic Substances Control Act (TSCA) reform measures recently circulated and invites you to participate in a webinar on Monday, May 10, 2010, at 11:00 a.m. – 1:00 p.m. (EDT). Details regarding the webinar are available here.
On April 15, 2010, Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010, S. 3209 (SCA), which is intended to address the “core failings” of TSCA. Also on April 15, 2010, Representatives Bobby Rush (D-IL), Chairman of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chairman of the Energy and Commerce Committee, released a discussion draft of their legislation, the Toxic Chemicals Safety Act of 2010 (Discussion Draft). (Congressional Committees often issue “discussion drafts.” These documents reflect proposals for reform of legislation, are works in progress intended to encourage and foster discussion, and are not proposed legislation.) Below is a summary of the Discussion Draft. Unless noted otherwise, the SCA includes similar provisions. Differences between the bills are noted.
The Discussion Draft includes the following:
- Section 1 (Short Title): The act is currently called the “Toxic Substances Control Act.” The Discussion Draft would rename TSCA the Toxic Chemicals Safety Act or TCSA, confusingly similar to TSCA. The SCA would rename TSCA the Safe Chemicals Act or SCA.
- Section 3 (Definitions): The Discussion Draft amends several existing definitions under TSCA and proposes several new definitions. Among the more important definitions and changes are the following:
- The current definition of Chemical Substance is changed in both bills. Both broaden the definition to include “chemical substance contained in or formed into an article,” for example. Another example of a significant change to the definition of a chemical substance found in both bills is viewed as an attempt to address nanoscale materials. The SCA states: “Notwithstanding molecular identity, the Administrator may determine, under Section 5(a)(6), that a variant of a chemical substance is a new chemical substance.” The Discussion Draft approach is as follows: “For purposes of this Act, such term may include more than one form of a substance with a particular molecular identity as described in subparagraph (A) if the Administrator has determined such forms to be different substances, based on variations in the substance characteristics. New forms of existing chemical substances so determined shall be considered new chemical substances.”
- Both bills change the definition of New Chemical to tie it to chemicals for which “the manufacturer or processor of the chemical substance has not submitted a declaration…”
- Chemical Identity is defined in the House Discussion Draft as, “with respect to a chemical substance (A) each common and trade name of the chemical substance; (B) the name of the chemical substance appearing in International Union of Pure and Applied Chemical nomenclature and 9th Collective Index format; (C) each Chemical Abstract Service registration number of the chemical substance; and (D) the molecular structure and the molecular identity of the chemical substance.” The underlined portion does not appear in the SCA version.
- The SCA would define Chemical Identity to include, with respect to a mixture, both “the chemical identities of the mixture’s component chemical substances,” and “the proportions [of] the mixture’s component chemical substances.”
- Importantly, with regard to the treatment of confidential business information (CBI), both bills change the definition of Health and Safety Study to include “the specific chemical identity of the chemical substance or mixture.”
- Substance Characteristic is defined “with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties of the chemical substance, including (A) chemical structure and composition; (B) size or size distribution; (C) shape; (D) surface structure; (E) reactivity; and (F) other characteristics and properties that may bear on toxicological properties.”The SCA does not define Substance Characteristic, but instead defines Special Substance Characteristics, which it defines as such “physical, chemical, or biological characteristics, other than molecular identity, that the Administrator determines, by order or rule, may significantly affect the risks posed by substances exhibiting those characteristics. In determining the existence of special substance characteristics, the Administrator may consider: (A) size or size distribution; (B) shape and surface structure; (C) reactivity; and (D) any other properties that may significantly affect the risks posed.” The Senate definition focuses on “risks posed,” whereas the House definition focuses on “toxicological properties.”
- Adverse Effect is broadly defined to include both “TSCA” and related exposures through food: “a chemical or biochemical change, anatomic change, or functional impairment, or a known precursor to such a change or precursor that: (1) affects or alters performance of an anatomic structure of a vital system of an organism or progeny of an organism; (2) causes irreversible change in the homeostasis of an organism; (3) increases the susceptibility of an organism or progeny of an organism to other chemical or biological stressors or reduces the ability of an organism or progeny of an organism to respond to additional health or environmental challenges; or (4) affects, alters, or harms the environment such that the health of humans or other organisms is directly or indirectly threatened.”
- Aggregate Exposure is defined as “(A) all exposure from the manufacture, processing, distribution, use and disposal of (i) a chemical substance or mixture; (ii) a substance that is not considered to be the chemical substance or mixture under clause (i) solely because the use of the substance as or in a food, food additive, drug, cosmetic, or device (as such terms are defined in Section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321)); and (iii) any mixture containing a substance described in clause (i) or clause (ii); and (B) all exposures from all other sources of a substance described in subparagraph (A), including (i) contamination of food, air, water, soil, house dust, and any other environmental media from current or prior uses or activity; (ii) accidental releases; (iii) permitted sources of pollution; (iv) nonpoint sources of pollution; and (v) documented background levels from natural and anthropogenic sources.”
- Cumulative Exposure is defined as the “sum of aggregate exposure to (A) each of the chemical substances that are known or suspected to contribute appreciably to the risk of the same or similar adverse effect; and (B) mixtures containing chemical substances described in subparagraph (A).”
- Bioaccumulative and Persistent are defined as those terms are defined in the U.S. Environmental Protection Agency’s (EPA) Policy Statement, Category for Persistent, Bioaccumulative, and Toxic New Chemicals, 64 Fed. Reg. 61094 (Nov. 4, 1999).
- Toxic with respect to a chemical substance or mixture is defined in the House Discussion Draft as a chemical substance or mixture that has a toxicological property “(A) that causes an adverse effect that has been demonstrated in humans or other organisms; or (B) for which the weight of evidence (such as demonstration of such an adverse effect as described in subparagraph (A) in laboratory studies or data for a chemical from the same chemical class that exhibits such as adverse effect) demonstrates the potential for an adverse effect in humans or other organisms.” The SCA draft definition also includes a chemical substance or mixture that has a toxicological property meeting the criteria for Category 1 or Category 2 for any of the toxicity endpoints established by the Globally Harmonized System for the Classification and Labeling of Hazardous Substances.
- Toxicological Property is defined as the “actual or potential toxicity or other adverse effects of a chemical substance or mixture, including actual or potential effects of exposure to a chemical substance or mixture on (A) mortality; (B) morbidity, including carcinogenesis; (C) reproduction; (D) growth and development; (E) the immune system; (F) the endocrine system; (G) the brain or nervous system; (H) other organ systems; or (I) any other biological functions in humans or other organisms.”
- Vulnerable Population is defined as a “population that is subject to a disproportionate exposure to, or potential for a disproportionate adverse effect from exposure to, a chemical substance or mixture, including (A) infants, children, and adolescents; (B) pregnant women; (C) the elderly; (D) individuals with preexisting medical conditions; (E) workers; and (F) members of any other appropriate population identified by the Administrator.” Of note is the inclusion of “workers” in the definition.
- Section 4 (Testing) — Creation of a Minimum Data Set: TSCA Section 4 authorizes EPA to promulgate rules requiring manufacturers, importers, and processors to test certain new or existing chemical substances or mixtures for their effects on human health and the environment. There is no current requirement that compels the submission of data for all chemical substances and mixtures. Both bills would require manufacturers and processors to submit to EPA a “minimum data set.” Importantly, the House Discussion Draft imposes this requirement on both chemical substances and mixtures while the Senate bill limits the requirement to chemicals. Further, the House version would amend the definition of Mixture to include articles (“any mixture contained in or formed into an article”), which would suggest that article mixtures would be subject to the minimum data set requirement.
- EPA would be required, within one year of enactment of TCSA, to issue a rule that sets forth what the exact “minimum data set” would be. The Discussion Draft provides the following criteria for EPA to consider in developing the data set rule: “The rule shall require . . . information on substance characteristics and on hazard, exposure, and use of chemical substances and mixtures that the Administrator anticipates will be useful in conducting safety standard determinations pursuant to Section 6(b) or carrying out any provision of this Act.” The rule shall also establish requirements for manufacturers and processors to update their minimum data set submissions, as appropriate. For existing chemicals, companies would be required to submit data within five years of enactment of TCSA, or within 18 months of being listed in the Section 6(a) priority list; while manufacturers of new chemicals would be required to submit data when submitting the pre-manufacture notice (PMN).While the SCA does not include language here regarding a “date certain” for this requirement regarding existing chemicals, it later states, in the section concerning safety determinations, that companies would be required to submit data no later than 14 years after enactment of the bill or within 30 months of being placed on the priority list, whichever is earlier. The SCA also states that companies would be required to submit the minimum data set within 18 months of the chemical being placed on the Section 6(a) priority list, or, for new chemicals, when submitting the PMN.
- Section 4 (Testing) — Additional Test Rules: Under TSCA, to require testing, EPA may issue a rule if it finds that “there are insufficient data and experience upon which the effects of the manufacture, distribution in commerce, processing, use, or disposal of such substance or mixture or of any combination of such activities on health or the environment can reasonably be determined or predicted,” and “testing of such substance or mixture with respect to such effects is necessary to develop such data.” EPA must also find that the chemical substance or mixture may present “an unreasonable risk” to human health or the environment, or is produced in substantial quantities that could result in substantial or significant human exposure or environmental release. The Discussion Draft would broaden EPA’s authority to require additional testing by allowing EPA to: (1) issue orders in addition to rules to require data; (2) require the submission of data “as necessary for making a safety standard determination under Section 6(b) or carrying out any provision of this Act”; and (3) prohibit from manufacturing, processing, or distribution any chemical substance or mixture for which minimum data set or testing requirements are not met.The SCA also includes a provision allowing EPA to require the submission of a sample of any chemical substance or mixture in such manner as enables EPA to conduct its own testing.
- Section 4 (Testing) — Requests from Other Federal Agencies for Additional Information or Testing: The Discussion Draft includes a new provision not currently in TSCA that would make explicit the ability of other federal agencies to request that EPA seek information “if a Federal agency determines that information relating to a chemical substance or mixture, including data derived from new testing or monitoring, would assist such agency in carrying out duties or exercising authority of such agency, but such information is not available to the agency.” Within 60 days of such a request, EPA must: (1) make the data available, if EPA is in possession of such data; (2) issue a rule or order under Section 8 requesting that the data be submitted to the requesting agency and EPA; (3) issue a rule or order under Section 4(b) requiring the development of the requested data; or (4) publish in the Federal Register its reason for not taking any of these actions.
- Section 5 (Manufacturing and Processing Notices) — New Chemical Substance and New Use Review: Under TSCA, manufacturers and importers must submit a PMN for any chemical substance to be manufactured or imported that is not listed on the public or confidential versions of the TSCA Inventory and that is not eligible for an exemption from PMN requirements. The PMN Form seeks information on the submitter’s identity, the chemical substance’s identity, production volume, uses, exposures, and environmental fate. TSCA does not require a submitter to test new chemical substances before submitting a PMN. Health and safety data relating to a new chemical substance’s health or environmental effects that are in a submitter’s possession or control, however, must be submitted with the PMN. EPA has certain authorities to control and require testing on PMNs. TSCA also includes several statutory exemptions (R&D, test marketing) and regulatory exemptions (Section 5(h)(4) as used for Low Volume and Polymer exemptions).Both bills would require a PMN for either manufacture or processing — currently, TSCA limits the PMN requirement to manufacture.The Discussion Draft would change several aspects related to the submission and review of PMNs. First, as noted above, manufacturers would be required to submit a minimum data set when the PMN is submitted. Second, the requirement is extended to “new mixtures” (note that the House Discussion Draft does not define the “chemical identity” of a mixture, so it is not clear if this is a listing of ingredients or also information on their proportions; the Senate bill’s definition of “chemical identity” specifies that this term for a mixture includes both the component chemicals and their proportions). In addition, a person may not manufacture or process a new chemical substance or mixture, or manufacture or process a chemical substance or mixture for a use that EPA has determined is a new use unless EPA, based on a review of the PMN, finds that: (1) “such substance or mixture, or use of such substance or mixture, is not reasonably anticipated to present a risk of injury to health or the environment, based upon anticipated use and production volume, toxicity, persistence, bioaccumulation, or other properties indicating risk”; or (2) the manufacturers and processors “have established that the anticipated use of the chemical substance or mixture meets the safety standard under Section 6(b).” If the new chemical substance or mixture or new use is reasonably anticipated to present a risk of injury to health or the environment, EPA must complete a safety standard determination within six months. The standard “not reasonably anticipated to present a risk of injury to health or the environment” is broader than the current standard, which requires EPA to determine that the substance “may present an unreasonable risk of injury to health or the environment.”The SCA would also require the submission of a minimum data set and PMN for new chemical substances (but not mixtures) and new uses of chemical substances. Unlike current TSCA, which requires a significant new use rulemaking to trigger such a notification requirement, “new uses” under SCA are determined based on revised declarations under Section 8(a) received from the manufacturer or processor. Under the SCA, EPA must find that the manufacturers and processors have established that the chemical substance meets the safety standard, or EPA must find that the new chemical substance is not, and is not expected to be:
- manufactured in a volume of more than 1,000,000 pounds annually or released into the environment in a volume of more than 100,000 pounds annually;
- a known, probable, or suspected reproductive, developmental, neurological, or immunological toxicant, carcinogen, mutagen, or endocrine disruptor, or has other toxicological properties of concern;
- persistent and bioaccumulative;
- found in human cord blood, or otherwise found in human blood, fluids, or tissue, unless the chemical substance or metabolite or degradation product is naturally present at the level commonly found in that medium; or
- found in food, drinking water, ambient or indoor air, residential soil, or house dust, unless the chemical substance or metabolite or degradation product is naturally present at the level commonly found in that medium.
- Section 6 — Development of Priority List for Safety Standard Determinations: The Discussion Draft proposes a new provision that would require EPA, no later than 18 months after the enactment of TCSA, to develop a list of no fewer than 300 chemical substances and mixtures for which safety standard determinations shall first be made. EPA has discretion in listing these chemicals, based on “available scientific evidence, consideration of their risk relative to other chemical substances and mixtures, presence in biological and environmental media, use, production volume, toxicity, persistence, bioaccumulation, or other properties indicating risk.” EPA can remove a chemical substance or mixture only after a safety determination has been made and must periodically add chemical substances and mixtures to the list so that the list never has fewer than 300 chemical substances and mixtures, until such time that all chemical substances and mixtures in commerce have had a safety determination. Substances may also be added to the list in response to TSCA Section 21 petitions or recommendations from the Interagency Testing Committee (ITC).The SCA does not include a provision for the ITC, but would instead create the Interagency Prioritization and Testing Committee (IPTC). The IPTC would maintain its own list of recommendations for the priority list, which it would update annually. The makeup of the IPTC would remain the same as the ITC — each of the following agencies would appoint one member from its officers or employees: EPA; Department of Labor; Council on Environmental Quality; National Institute for Occupational Safety and Health; National Institute of Environmental Health Sciences; National Cancer Institute; National Science Foundation; and Department of Commerce.Under the SCA, the following actions shall not be subject to judicial review, “including when a prioritization decision or recommendation coincides with or is based on other decisions under this chapter that are subject to judicial review”: (1) a decision whether to place a particular chemical substance on the priority list; (2) a response to a petition to place a particular chemical on the priority list; and (3) the issuance of an IPTC recommendation. The SCA states that EPA’s failure to establish the priority list, or to update the list as required, shall be: (1) “considered to be a failure to perform a nondiscretionary duty”; and (2) “subject to judicial review.”
- Section 6 — Safety Standard Determination: The Discussion Draft proposes a new provision that would require EPA to apply a “safety standard.” The standard must “take into account aggregate and cumulative exposure to a chemical substance or mixture and that provides a reasonable certainty of no harm, including to vulnerable populations, and protects the public welfare from adverse effects, including adverse effects to the environment.” Significantly, manufacturers and processors have the burden to prove that the chemical substance or mixture meets the safety standard. EPA has six months after the submission of all necessary information to make a determination as to whether a manufacturer or processor has met its burden of proof. EPA must make its determination available publicly and provide a list of allowed uses as well as any conditions on those uses that are necessary to ensure that the safety standard is met. EPA’s safety determinations would remain in effect for 15 years, unless a new use of such chemical substance or mixture is proposed or new information on such chemical substance or mixture warrants a redetermination. Although the SCA repeatedly references the “safety standard under Section 6(b)” or “the applicable safety standard,” it does not include the language for the safety standard.Significantly, under the SCA a determination by EPA that a manufacturer or processor has not established that the chemical substance meets the safety standard “shall not be subject to judicial review.” The SCA would require manufacturers and processers to submit, not later than 15 years after enactment, the minimum data set and indicate whether the chemical substance, including specified uses to be evaluated and any proposed conditions on the specified use, meets the safety standard. The SCA would also allow any person to petition EPA for a redetermination of whether a chemical substance continues to meet the applicable safety standard. The petition must include “a description of the basis for requesting the redetermination.” EPA would have 180 days after receipt of the petition to publish its decision, and the basis for its decision, in the Federal Register.
- Section 6 — Risk Management: Under TSCA Section 6, EPA is authorized to restrict or ban the manufacture, processing, or distribution in commerce of chemical substances or mixtures upon showing that the activity “presents or will present an unreasonable risk of injury to health or the environment.” EPA currently must select the least burdensome of the regulatory options available to it that is adequate to achieve its regulatory objectives. Because of the restrictions on EPA’s authority to regulate existing chemicals, EPA exerted its Section 6 authority sparingly and was never successful in using its Section 6 authority to ban a substance. With the new safety determinations proposed in the Discussion Draft, significantly more chemicals would be assessed by EPA, and EPA would have significantly greater discretion to take action for chemical substances or mixtures that are determined by EPA to not meet the safety standard. If EPA determines that the safety standard has not been met for a new chemical substance or mixture or new use, then that chemical substance or mixture cannot be manufactured, processed, or distributed in commerce. If EPA determines that the safety standard has not been met for an existing chemical substance, then that chemical substance or mixture cannot be manufactured, processed, or distributed in commerce effective one year after publication of that determination. Actions EPA can take if it finds that conditions must be imposed to ensure that the chemical substance or mixture meets the safety standard include: (1) prohibiting the manufacture, processing, or distribution in commerce of a chemical substance or mixture, a particular use of a chemical substance or mixture, or a particular use in a concentration in excess of a level specified by EPA; (2) limiting the amount that can be manufactured, processed, or distributed in commerce of a chemical substance or mixture, a particular use of a chemical substance or mixture, or a particular use in a concentration in excess of a level specified by EPA; (3) requiring clear and adequate warnings and instructions with respect to the use, distribution in commerce, and disposal of a chemical substance or mixture; (4) imposing recordkeeping requirements; (5) prohibiting or limiting any manner or method of disposal; and (6) requiring the development of a risk reduction management plan to achieve a risk reduction specified by EPA.The SCA includes a provision concerning quality control orders which is related to a provision in the current TSCA. Under the SCA, if EPA has a “reasonable basis” to conclude that a particular manufacturer or processor is manufacturing or processing a chemical substance or mixture in a manner that may present a substantial endangerment to health or the environment, EPA may by order require the manufacturer or processor to submit a description of the quality control procedures followed. If EPA determines that the quality control procedures are inadequate to prevent the chemical substance or mixture from presenting a risk of injury, EPA may order the manufacturer or processor to revise the quality control procedures to the extent necessary to remedy the inadequacy. If EPA determines that the quality control procedures have resulted in the distribution in commerce of a chemical substance or mixture that may present “a substantial endangerment to health or the environment,” EPA may order the manufacturer or processor to: (1) give notice of the endangerment to processors and/or distributors, and, to the extent reasonably ascertainable, “any other person in possession of or exposed to the substance or mixture”; (2) give public notice of the endangerment; and (3) provide for the replacement or repurchase of the substance or mixture as is necessary to protect adequately health or the environment.Both the SCA and the Discussion Draft authorize the Administrator to issue time limited exemptions from Section 6 restrictions for certain uses. Referred to in the Discussion Draft as “critical use exemptions” and merely an exemption in the SCA, the Administrator may, by order, exempt a specific use of a chemical from a restriction for a period not to exceed five years (renewable for one or more additional five-year periods) if, by “clear and convincing evidence,” the manufacturer or processor demonstrates that the exemption: is needed in the interests of national security; would “significantly affect the national economy”; is needed to protect a “critical or essential use”; is needed because there is no “feasible safer alternative” for the use; or the use provides a “net benefit to health or the environment when compared to all available alternatives.” Renewal of the exemption is contingent upon a demonstration that the use continues to meet the exemption criteria. Under the SCA, notice of the exemption must be provided by the manufacturers and processors to known purchasers of the chemical and each known purchasers of a mixture or article containing the chemical substance. The Administrator must provide the public with notice of the exemption. The Discussion Draft only requires that manufacturers and processors provide notice to known purchasers of the chemical substance or mixture.
- Section 8 (Reporting) — Declaration of Manufacturing or Processing: Both bills propose a new requirement that each manufacturer or processor, within one year of enactment, provide a declaration of current manufacturing or processing of a chemical substance or mixture. The declaration would include the chemical identity of the chemical substance or mixture; data about where manufacture, processing, and distribution occurs; a list of existing health and safety studies; and “all other information known to, in the possession or control of, or reasonably ascertainable by the manufacturer that has not previously been submitted to” EPA regarding physical, chemical, and toxicological properties of the chemical substance or mixture, annual production volumes, known uses and exposure data, and the name and location of each facility to which the chemical substance or mixture is sent, after manufacture or processing, for subsequent processing, distribution, or use. A manufacturer or processor also can declare that it has ceased, or will cease within 180 days of submission of the declaration, all production, importation, processing, and export of the chemical substance. Manufacturers and processors would have to update these declarations every three years, or immediately when there is “significant new information regarding a physical, chemical, toxicological property or use of, or exposure to, the chemical substance or mixture, including any information that demonstrates a potential new adverse effect of the chemical substance or mixture, corroborates previous information demonstrating or suggesting an adverse effect, or suggesting an adverse effect at a lower dose than previously demonstrated.”
- Section 8 (Reporting) — Inventory: The House Discussion Draft would require that all chemical substances and mixtures in commerce be compiled and maintained in the Inventory. In the SCA, the Inventory is to include each chemical substance that is manufactured or processed and, pursuant to new Section 8(c)(2), the contents shall include new chemicals entering commerce and reports under the new Section 8(b). This section does not reference the declarations made under Section 8(a) in the SCA bill.
- Section 8 (Reporting) — Categorization: The Discussion Draft proposes a new requirement that EPA, no later than five years from enactment of TCSA, publish a list of all chemical substances and mixtures distributed in commerce that “categorizes the chemical substances and mixtures, based on existing information available to the Administrator, based upon known health or environmental effects, exposure, insufficient data, or other category that the Administrator deems appropriate.”
- Section 8 (Reporting) — Public Database: The Discussion Draft proposes to establish, no later than one year from enactment of TCSA, a public database that would include chemical information submitted to EPA, and EPA’s decisions regarding chemicals.
- The Discussion Draft also revises the current TSCA Section 8(c) allegations to require that allegations received (by a manufacturer, processor, or distributor) be submitted to EPA “on an annual basis.”
- Section 9 (Relationship to Other Federal Laws): TSCA Section 9 addresses the relationship of EPA’s TSCA authority to that granted to other agencies under other federal laws. Under Section 9, EPA must submit a formal report to another federal agency when EPA: (1) has a reasonable basis for determining that a chemical substance or mixture poses an unreasonable risk of health or environmental injury; and (2) determines that the risk may be prevented or sufficiently reduced by action taken by another federal agency under a law not administered by EPA. EPA may not act under either TSCA Sections 6 or 7 with respect to the substance if the other agency either: (1) initiates action to regulate the unreasonable risk; or (2) issues an order stating that the risk described by EPA is not unreasonable. The Discussion Draft proposes to strengthen EPA’s ability to take action should EPA request that another agency decide not to take action within that agency’s jurisdiction to reduce risks from chemical substances that failed to meet the safety standard, or would fail to meet the standard without risk management actions.
- Section 12 (Export Notification): Under TSCA Section 12(b), EPA has authority to require notification by persons intending to export certain chemical substances. The Discussion Draft proposes a few modifications to the current notification requirements, including: (1) specifying that notifications are required “not later than 30 days after the date of exportation of the substance or mixture”; (2) requiring notifications when an action has been taken pursuant to Section 6(c) or 7; (3) requiring exporters to provide to EPA a change in export status of the substance or mixture not later than 30 days after such a change in status; (4) changing the timeframe for reporting for exporters of chemicals listed under the Rotterdam Convention on Prior Informed Consent (PIC), so that such exporters submit notifications 30 days prior to the date of exportation; and (5) requiring EPA to maintain copies of notices provided to other governments and make the notices available publicly. Note that in the House Discussion Draft new Section 12(c) seemingly requires compliance with TSCA export notice requirements for all chemicals listed under the Rotterdam Convention regardless of whether the U.S. is a party to that Convention.The SCA does not include a provision in this section regarding chemicals listed under the PIC Convention.
- Section 14 (Disclosure of Information) — Narrow Confidentiality Claims: TSCA Section 14(a) prohibits EPA, except in certain limited circumstances, from disclosing to the public trade secrets, and commercial or financial information that is privileged or confidential. The Discussion Draft proposes to narrow the conditions under which data could be claimed as CBI. EPA would be required, within one year of enactment of TCSA, to publish “standards that specify the acceptable bases on which designations [by manufacturers, processors, and distributors] under paragraph (1) to maintain confidentiality of information may be approved [by EPA] under subparagraph (B), which shall be no more restrictive of public disclosure than [the Freedom of Information Act], and the documentation needed to accompany such documentation.” The Discussion Draft sets forth certain categories of information that are not eligible for confidential protection: (1) chemical identity, “except as provided in section 5,” except that there is not relevant discussion on CBI treatment of chemical identity in Section 5; (2) any safety standard developed under Section 6(b), including any supporting information developed by EPA; (3) any health and safety study (recall that the definition of health and safety study was revised to include chemical identity information): (a) with respect to any chemical substance or mixture that has been offered for commercial distribution or for which testing has been required under Section 4 or notification required under Section 5; and (b) any data reported to or otherwise obtained by EPA from a health and safety study which relates to a chemical substance or mixture; and (4) any information indicating the presence of a substance or mixture in an article intended for use or reasonably expected to be used by children or to which children can otherwise be reasonably expected to be exposed. EPA would be required to review all confidentiality requests — that would be submitted with each company’s justification for its confidential request, a certification that the information is not otherwise available publicly, and separate copies of the information with the confidential information redacted — within 90 days of receipt and determine whether the request should be approved or denied. If a confidential designation is denied, EPA must make the information available to the public. If a confidential designation is approved, EPA must specify a time period of not greater than five years for which the information will be maintained as confidential. The Discussion Draft also proposes a new provision would require EPA to provide standards for and facilitate the sharing of chemical identity information, safety determinations, and health and safety data with workers and their representatives.
- Section 15 (Prohibited Acts): Under TSCA Section 15, it is unlawful to (1) fail or refuse to comply with a Section 4 test rule or order; or any rule, order, or requirement issued under Sections 5 or 6; (2) use for commercial purpose a chemical substance or mixture which the person knew or had reason to know was manufactured, processed, or distributed in violation of Sections 5 or 6, or a rule or order issued under Sections 5, 6, or 7; (3) fail or refuse to establish or maintain records, submit reports, notices, or other information, or permit access to or copying of records required under TSCA; or (4) fail or refuse to permit entry or inspection as required by Section 11. The Discussion Draft proposes to remove references to specific TSCA sections and instead state that it is unlawful to make a false submission under EPA or to fail or refuse to comply with any rule, order, prohibition, restriction, or other requirement imposed by TCSA or by EPA under TCSA.
- Section 16 (Penalties): Under TSCA Section 16, EPA can impose civil penalties for each violation of Section 15, with each day constituting a separate violation. The Discussion Draft would increase civil penalties and add significant criminal penalties for “knowing endangerment,” similar to the provisions in the Resource Conservation and Recovery Act.
- Section 18 (Preemption): Neither bill contains provisions that clearly address the concerns identified by chemical manufacturers concerning the plethora of state and local requirements that make interstate marketing, sale, and distribution of chemical products challenging. TSCA Section 18 preempts states and political subdivisions of a state from enacting requirements applicable to a chemical substance or mixture that is regulated under TSCA Section 5 or 6, unless the state requirement is identical to the federal requirement, implements another federal law, or prohibits use of the substance or mixture within the state. A state or political subdivision may ask EPA to allow a requirement that provides a significantly higher degree of protection from risk than does the federal requirement. Under the Discussion Draft, states or political subdivisions would have the ability to adopt or enforce requirements that are different from or in addition to requirements established under the TCSA, unless compliance with both TCSA and the state or political subdivision requirement “is impossible.” The SCA states that neither the SCA, nor any rule, regulation, or order issued or promulgated pursuant to the SCA, would “preempt, displace or supplant any provision of any law, including common law, of any State or political subdivision of a State relating to any chemical substance or mixture, or any article that contains a chemical substance or mixture, which is more stringent than is provided for under this chapter.”
- Section 19 (Judicial Review): TSCA Section 19 sets forth the circumstances when a party can seek judicial review. The Discussion Draft proposes to remove the definition of rulemaking record and to remove the TSCA exception from general Administrative Procedures Act (APA) requirements regarding the standard of review. A court would have jurisdiction to “grant appropriate relief,” including interim relief, and to review such rule or order in accordance with Chapter 7 of Title 5, United States Code. Under the Discussion Draft, courts would no longer be directed to hold unlawful and set aside rules where the court finds that the rule is not supported by substantial evidence in the rulemaking record. Instead, courts would use the APA standard of review, and would invalidate EPA’s rules or orders only where the court finds that EPA’s action was “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.”
- Section 28 (State Programs) — Coordination: Under the Discussion Draft, EPA would establish a process to coordinate with states, on an on-going basis, to share data and priorities relating to the management of chemical substances and mixtures under the TCSA and under state programs.
- Risk Assessment for Chemical Substances and Mixtures That Are Persistent, Bioaccumulative, and Toxic: The Discussion Draft proposes a new Section 32 that would require EPA, within one year of enactment of TCSA, to establish a methodology for tailoring safety standard determinations for chemical substances and mixtures determined to be persistent and bioaccumulative. For each substance listed on the Section 6(a) priority list, EPA must determine if the chemical substance or mixture is persistent or bioaccumulative and conduct safety standard determinations. EPA also would be authorized to take action under Section 6(c) as necessary to ensure that the manufacturing, processing, distribution in commerce, use, and disposal of a chemical substance or mixture identified as persistent or bioaccumulative meets the safety standard.The SCA does not include a similar provision.
- Expedited Action for Chemical Substances with Documented Risks: The Discussion Draft proposes a new Section 33 that identifies chemical substances “for which risk to health or the environment is well documented yet sufficient risk management actions have not been taken.” Over 30 chemical substances are listed, including asbestos, bisphenol A, formaldehyde, methylene chloride, certain perfluorocholinated compounds, certain phthalates, and vinyl chloride. For listed chemical substances, EPA must take expedited action by completing a safety standard determination within one year of enactment of TCSA and taking any required risk management actions to ensure the chemical substances and mixtures meet the safety standard. Manufacturers and processors of identified chemical substances and mixtures would not be required to submit the minimum data set required under amended Section 4, but they would be required to submit the declaration required by the new provision in Section 8 within six months after enactment of TCSA to inform EPA’s determination. No person may manufacture or process a new use of a listed chemical substance or mixture, except as those specifically exempted under Section 6(e) and in accordance with the redetermination process of Section 6(b)(5).Although the SCA also includes a section regarding “expedited action on chemicals of highest concern,” the section does not identify any specific chemicals. Instead, the section states only: “The Administrator shall act quickly to manage risks from chemical substances that clearly pose the highest risks to human health or the environment.”
- Children’s Environmental Health Program: The Discussion Draft proposes a new Section 34 that would establish within 90 days of enactment of TCSA a Children’s Environmental Health Research Program to understand better the vulnerability of children to chemical substances and mixtures, and an Interagency Science Advisory Board on Children’s Health and Toxic Substances.
- Reduction of Animal-Based Testing: The Discussion Draft proposes a new Section 35 that would require EPA to minimize the use of animals in testing of chemical substances or mixtures by encouraging the use of existing data, grouping of chemical substances for testing, formation of industry consortia to reduce redundancy, use of existing methods that eliminate or reduce the use of animals, and the development and validation of emerging methods and models. The Discussion Draft also proposes to establish an Interagency Science Advisory Board on Alternative Testing Methods and develop a strategic plan to promote alternative methods.
- Create Market and Other Incentives for Alternatives to Existing Chemicals: The Discussion Draft proposes a new Section 36 that would require EPA, within one year of enactment of TCSA, to establish a program to develop market and other incentives for safer alternatives to existing chemical substances and mixtures that reduce or avoid the use or generation of hazardous substances. New chemical substances or mixtures that a manufacturer or processor claim are safer alternatives would be subject to expedited review. The program also would require the development of special designations, public awards, and rewards to recognize chemical substances or products that EPA determines are safer alternatives. The Discussion Draft also would require the establishment of a Green Chemistry Research Network, consisting of regional green chemistry and engineering centers, to support the development and adoption of safer alternatives to existing chemical substances and mixtures.The SCA would also create a Green Chemistry Workforce Education and Training Program. The goals of the Program would be to provide workforce training on skills that would: (1) facilitate the expansion of green chemistry; (2) develop scientific and technical leadership in green chemistry; (3) facilitate the successful and safe integration of green chemistry into infrastructure projects; (4) inform and engage communities about green chemistry; and (5) promote innovation and strong public health and environmental protections. EPA would implement the Program by helping to develop a broad range of skills relevant to the production and use of such safer alternatives, including their design, manufacturing, and use and disposal; offering to develop partnerships with educational institutions, training organizations, private sector companies, and community organizations; and providing grants to state and local governments and to the partnerships established to promote and support activities consistent with achieving the goals of the Program.
- Cooperation with International Efforts: The Discussion draft proposes a new Section 37 that would require EPA to cooperate “with any international efforts” to develop a common electronic database for chemical substances and mixtures or to develop safer alternatives for chemical substances that EPA determines has broad international support and a reasonable expectation of success. The Discussion Draft would prohibit, within five years of enactment of TCSA and seemingly regardless of U.S. party status, the manufacturing, processing, distribution in commerce, use, and disposal of five substances that were listed under or have been added to the Stockholm Convention except if a use is exempted under Section 6(e). EPA also would be required to publish in the Federal Register a list of all substances that are subject to the Stockholm Convention on Persistent Organic Pollutants (Stockholm Convention), the PIC Convention, and the Protocol on Persistent Organic Pollutants to the Long Range Transboundary Air Pollution Convention (LRTAP POPs Protocol) and develop procedures for the phase out of such chemicals. Under the Discussion Draft, in consultation with the Secretary of State and any other appropriate federal agency, EPA would implement the provisions of international agreements related to chemical substances to which the U.S. becomes a party. EPA would provide public notice and opportunity to comment on chemicals proposed for listing. EPA may “require any person that manufactures, processes, distributes in commerce, uses, or disposes of the chemical substance or mixture to provide to the Administrator any information that the Administrator determines to be necessary to assist the U.S. in its consideration of the proposal.” The Discussion Draft would give EPA the authority to promulgate regulations to carry out the provisions of the international treaties.While the SCA includes a section regarding cooperation with international efforts, the section addresses only developing a chemical substance database and developing safer alternatives. In a later section, SCA addresses implementation of the Stockholm Convention, the LRTAP POPs Protocol, and the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade (Rotterdam Convention). The approach taken is significantly different from previously proposed legislation which was intended to meet the implementation requirements under these Conventions and will require careful analysis to ensure that all U.S. obligations as a party can be met.
- Address Public Exposure to Toxic Chemicals in “Hot Spot” Locations: The Discussion draft proposes a new Section 39 that would require EPA to identify, assess, and develop action plans to address any disproportionate exposures of residential populations in certain localities to chemical substances and mixtures. EPA would be required within 180 days of enactment of TCSA to promulgate a rule that would establish criteria to define disproportionate exposure and identify those localities that are disproportionately exposed. With input from the public and use of available data, EPA would then be required to publish a list of affected localities. Within one year of publishing or updating that list (such updating is required at least every five years), EPA would be required to develop and publish an action plan for each identified locality that includes the chemical substances and mixtures contributing to the disproportional exposure. EPA also would be required to provide to Congress an annual report identifying the localities, providing the action plans, and describing the progress on each action plan to date.The SCA includes a subsection regarding actions that shall not be subject to judicial review: a decision to identify a locality to be included on the list; a decision in response to nominations submitted; and a decision to list localities or update the list. Under the SCA, the failure of EPA to publish the list of localities or update the list shall be considered to be a failure to perform a nondiscretionary duty, and thus subject to judicial review.
Observations and Comments
Even from this relatively short summary, the breadth and depth of these proposed changes to TSCA are evident. Every one of the now-familiar “failures” of the current law are addressed in ways that are mostly stark and radically different from the current program. This is clearly the intent of many of the supporters of the legislation, even if some of the sponsors will have to concede changes if anything resembling a consensus among interested groups is to be had. Even if one assumes there is some element of an extreme negotiating position at the beginning of the TSCA bazaar, there is a risk that any final bill will come up short in comparison to the grand ambitions described in the current drafts.
The opening Congressional measures would appear to countenance an almost complete takeover of the current chemical industry by EPA, with any significant change (however defined) in exposure or production needing a new loop through some kind of EPA scrutiny/process. For chemicals found to be of significant risk concern, this may be appropriate. If, however, one assumes that at least some fraction of current chemical production is not likely to present significant risks, then products of less risk concern would be likely to clog the new approval systems leaving less time and resources to focus on “real risks.” Of course, according to critics of TSCA, the lack of scrutiny for the existing chemical universe over the past 30+ years is one of the major gaps the proposals seek to address. And, as discussions continue, major points of debate concerning greater distinctions among and between kinds of chemical categories and a more rationalized and focused reporting and testing burden (appropriate volume cut-offs, risk characterization assumptions, the extent and timing of data requirements, etc.) are likely to emerge.
The current proposals also introduce some novel mechanisms for “forcing” EPA decisions and encouraging coordinated action among and between federal agencies. The uber-IPTC (Interagency Prioritized Testing Committee) concept, and the revitalized Section 9 hand-off process between agencies would represent a departure from the current inter-agency dynamics. Even more radical is the authority for EPA to issue orders, not rules, to implement virtually the entire array of new requirements imposed on EPA, many authorized as not subject to judicial review. EPA could impose testing requirements, make safety determinations, and order risk mitigation (including production method changes) with unrivaled authority and speed. These new powers would certainly accelerate EPA decision-making, and if successfully enacted, could be a template for other agencies to seek authority to hasten decision-making for chemical exposure issues. Critics of the current process would welcome such changes, while presumably stakeholders in the chemical industry can expect to seek in both the SCA and Discussion Draft a more complete system of checks and balances.
Without significant modifications to reveal how Congress wishes EPA to triage the existing chemical world, it is unclear how EPA can meet anything resembling the deadlines outlined in the drafts. Concerning new chemicals, the trade-off between innovation in the U.S. chemical industry and any appropriate pre-market data requirements will be a subject of difficult negotiation (and ironically mirrors the most difficult part of the legislative debate when TSCA was first considered in the mid-1970’s).
It is at least theoretically possible that the ongoing discussions on the House Discussion Draft will help to disclose and begin to sort through some of the more significant problems with the conceptual approach to chemical regulation embedded in both the SCA and the Discussion Draft. If this can occur, it could help to galvanize support for approaches that could begin to reflect a measure of the consensus among stakeholders that the broad “statements of principles” seemed to suggest existed at some level earlier this year. As that process is very much in play, it is too soon to speculate on its outcome. Similarly, it is too soon to speculate on the influence the fast approaching mid-term elections will have on both the negotiating posture and outcome of this debate. Stakeholders may wish to use this time as a much needed opportunity to engage in meaningful discussion on the most important provisions in the Discussion Draft to ensure significant issues are addressed wisely, and resist temptations to tread water based on the hope that a new Congress will offer deliverance.
We have prepared the chart below to illustrate the aggressive timeframes for action under the TCSA.
Timeline for Required EPA Actions per House Toxic Chemicals Safety Act of 2010
|Within 2 months/60 days of enactment||Publish notice of chemicals subject to international agreements|
|Within 3 months/90 days of enactment||Establish Interagency Science Advisory Board on Alternative Testing MethodsEstablish Children’s Environmental Health ProgramEstablish Interagency Science Advisory Board on Children’s Health and Toxic SubstancesEstablish process to review new chemical submissions coming — not articulated in legislative text, but given 90-day review timeline specified, a process would need to be in place to accommodate any new chemical submissions coming in after TSCA 2010 enactment|
|Within 6 months/180 days||Promulgate rulemaking to establish criteria for environmental hot spotsEstablish process and guidance for manufacturers of substances on list of expedited action for chemicals with documented risks (Section 33) — not articulated in legislative text but given requirement for manufacturers to submit declarations within six months, there would need to be a process in place and guidance provided|
|Within 10 months||Identify localities that meet criteria for environmental hot spots|
|Within 12 months||Determine whether chemicals on list for expedited action (Sec 33) meet safety standardPromulgate rulemaking for evaluating persistent-bioaccumulative substancesDevelop standards for confidential business information claimsEstablish electronic databaseEstablish procedures for maintaining and updating databaseEstablish minimum data set requirements for listed substancesEstablish requirements for updating data setEstablish program to create market incentives for safer alternativesEstablish process and guidance for manufacturers of substances to submit declarations for priority substances — not articulated in legislative text but given requirement for manufacturers to submit declarations within one year, there would need to be a process in place and guidance provided|
|Within 16 months||Publish list of environmental hot spot localities|
|Within 18 months||Publish list of priority substances for safety standard determinationEstablish procedures to ensure data quality|
|Within 2.5 years||Issue action plans to address listed environment hot spot localities|
|Within 5 years||Publish list of chemicals in commerce|
|No timeframe articulated in text — but listed as EPA action|