Regulatory Developments

House Introduces TSCA Reform Legislation: Summary and Comparison of House and Senate Bills and House Discussion Draft

July 28, 2010 PRINT

On July 22, 2010, Representatives Bobby Rush (D-IL), Chair of the Subcommittee on Commerce, Trade, and Consumer Protection, and Henry Waxman (D-CA), Chair of the Energy and Commerce Committee, introduced the Toxic Chemicals Safety Act of 2010 (H.R. 5820) (TCSA), which is intended to strengthen the Toxic Substances Control Act (TSCA). On July 27, 2010, the House Committee on Energy and Commerce issued a briefing memo announcing a Subcommittee on Commerce, Trade, and Consumer Protection legislative hearing on H.R. 5820. The hearing is scheduled for July 29, 2010. Witnesses scheduled to appear before the Subcommittee include Steve Owens, U.S. Environmental Protection Agency (EPA) Assistant Administrator of the Office of Chemical Safety and Pollution Prevention; Richard Denison, Ph.D., Senior Scientist, Environmental Defense Fund; Calvin M. Dooley, President and Chief Executive Officer, American Chemistry Council; Howard Williams, Vice President, Construction Specialties, Inc.; Mark Mitchell, M.D., MPH, President, Connecticut Coalition for Environmental Justice; and Beth Bosley, Society of Chemical Manufacturers and Affiliates, Inc. Earlier this year, on April 15, 2010, Rush and Waxman released a discussion draft of their TSCA reform legislation, and Senator Frank R. Lautenberg (D-NJ) released the text of the Safe Chemicals Act of 2010 (S. 3209) (SCA), which is also intended to reform TSCA. Below is a summary of the TCSA. Unless noted otherwise, the SCA includes similar provisions. Differences between the bills are noted, as well as differences between the TCSA and the discussion draft of the House TSCA reform legislation.

The TCSA includes the following:

  • Section 1 (Short Title): The act is currently called the "Toxic Substances Control Act." The TCSA would rename TSCA the Toxic Chemicals Safety Act of 2010 or TCSA, confusingly similar to TSCA. The SCA would rename TSCA the Safe Chemicals Act or SCA.
  • Section 3 (Definitions): The TCSA 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. While both the discussion draft and the SCA would broaden the definition to include "chemical substance contained in or formed into an article," this phrase has been dropped from the TCSA. Both bills attempt to address nanoscale materials. The TCSA, using language similar to that in the discussion draft, would allow the EPA Administrator to "determine different forms of a chemical substance with a particular molecular identity to be different chemical substances for purposes of this Act, based on variations in the substance characteristics. New forms of existing chemical substances so determined shall be considered new chemical substances for purposes of this Act." 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."
    • TCSA is particularly confusing and complex with regard to its treatment of mixtures. TCSA revises the TSCA definition of Mixture using the term "composition" rather than TSCA's "combination": "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." Under the TCSA, the Administrator may determine different mixtures comprised of the same chemical substances to be the same mixture for purposes of this Act, "if the substance characteristics of the mixtures are identical. Mixtures which would be considered new mixtures but for grouping under this paragraph shall not be considered new mixtures for purposes of this Act." In addition, the TCSA would require that within six years EPA characterize the number of mixtures introduced into U.S. commerce, and the number of such mixtures "that have or may have substance characteristics that are different, in kind or degree, from the substance characteristics of the constituent chemical substances." EPA shall publish its results in the Federal Register, as well as in the public database.
    • Both bills change the definition of New Chemical to tie it to chemicals "for which no declaration has been submitted." TCSA also clarifies that this provision does not apply for the 1 year period after enactment and thus recognizes that declarations would not be available at the outset.
    • Chemical Identity as defined in the discussion draft was largely retained in TCSA and reads "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) the Chemical Abstracts 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."
    • With regard to the treatment of confidential business information (CBI), both the SCA and discussion draft would change the definition of Health and Safety Study to include "the specific chemical identity of the chemical substance or mixture." This has been dropped from the TCSA as it retains the TSCA definition unchanged.
    • The TSCA definition of Distribute in Commerce was revised in the TCSA to explicitly include export. This does not appear in the discussion draft or SCA.
    • TCSA revises the TSCA definition of Process to exclude processing activities related solely to pesticides, drugs, food, food additives, and cosmetics, and further clarifies that processing does not include relabeling or redistribution of a substance or mixture where repackaging does not occur. In the case of articles, relabeling, redistributing, or repackaging an article "including incorporating the article into another article, does not constitute processing." Seemingly, this means that, for example, manufacturing a car is not processing insofar as the component articles are concerned.
    • Substance Characteristic is defined in TCSA "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 or the exposure potential of the substance, including -- (A) 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 or exposure potential." Importantly, TCSA has added the concept of "exposure potential" to the definition.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."
    • The definition of Adverse Effect has been broadened in TCSA from the discussion draft by substituting "potential to impair" for "affects or alters": "a chemical or biochemical change, anatomic change, or functional impairment, or a known precursor to such a change or impairment that: (A) has the potential to impair the performance of an anatomic structure of a vital system of an organism or progeny of an organism; (B) causes irreversible change in the homeostasis of an organism; (C) 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 (D) affects, alters, or harms the environment such that the health of humans or other organisms is directly or indirectly threatened." TCSA also allows EPA by rule to revise the statutory definition "in such a way that reflects the state of the science and provides for equal or greater protection of health and the environment." It is not a common practice for Congress to authorize revisions to a statutory definition.
    • Aggregate Exposure is defined under TCSA without reference to a specific chemical substance (except as noted in (B) below) and thus seems to encompass all exposures to all chemicals: "all exposure from -- (A) manufacture, processing, distribution, use, and disposal; (B) manufacturing or processing of the substance for use as a pesticide, food, food additive, drug, cosmetic, or device; (C) contamination of food, air, water, soil, house dust, and any other environmental media from current or prior uses or activity; (D) permitted sources of pollution; (E) nonpoint sources of pollution; and (F) documented background levels from natural and anthropogenic sources." While TCSA deleted "accidental releases" from the discussion draft definition, the TCSA definition without a broad reference to specific chemicals is impractical.
    • Cumulative Exposure is defined in TCSA as the "sum of aggregate exposure to -- (A) each of the chemical substances that are known or, where supported by scientific consensus, suspected to contribute appreciably to the risk of the same adverse effect; and (B) mixtures containing chemical substances described in subparagraph (A)." The TCSA definition differs from that in the discussion draft in that "similar" was deleted from "same or similar adverse effect" and the meaning of "suspected" was clarified by the addition of "where supported by scientific consensus." The net effect seems to narrow the definition, although the meaning of "scientific consensus" is unclear.
    • Bioaccumulative is defined as "with respect to a chemical substance or mixture, that the chemical substance or mixture, as determined by the Administrator, can significantly accumulate in biota, as indicated through monitoring data, or is highly likely to accumulate in biota, as indicated by other evidence."
    • Persistent is defined as "with respect to a chemical substance or mixture, that the chemical substance or mixture, as determined by the Administrator, significantly persists in 1 or more environmental media, as indicated by monitoring data or other evidence." This approach thus applies "bioacumulative" and "persistent" to specific chemical determinations made by EPA whereas both the SCA and the discussion draft define Bioaccumulative and Persistent as concepts consisting of criteria contained in EPA's Policy Statement, Category for Persistent, Bioaccumulative, and Toxic New Chemicals, 64 Fed. Reg. 61094 (Nov. 4, 1999). The effect of the change in TCSA is seemingly to tie the definitions to TCSA Section 32 concerning development of criteria and listing of chemicals that are PBTs (persistent, bioaccumulative, and toxic).
    • Toxic as defined in the TCSA with respect to a chemical substance or mixture, "means that the chemical substance or mixture, or a metabolite or degradation product of such substance or mixture, in the TCSA as 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 an adverse effect) demonstrates the potential for an adverse effect in humans or other organisms." The underlined language concerning metabolites or degradation products is new. The SCA 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 "established toxicity, adverse effects, or established precursors to such toxicity or adverse effects, including effects of exposure to a chemical substance or mixture on (A) mortality; (B) morbidity, including carcinogenesis; (C) genetics, including mutagenicity, genotoxicity, and epigenetics; (D) reproduction; (E) growth and development; (F) the immune system; (G) the endocrine system; (H) the brain or nervous system; (I) other organ systems; or (J) any other biological functions in humans or other organisms." The discussion draft had used the terms "actual or potential toxicity" and "actual or potential effects of exposure" in lieu of TCSA's "established toxicity" and "effects of exposure" language and thus represents a narrowing of the definition. Seemingly, the change relates at a minimum to the new provision at Section 39 in TCSA that discusses "intrinsic properties." Note also that the minimum data set at Section 4(a) of TCSA specifies "toxicological properties" as one of the components of the minimum data set.
    • 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 (including effects on fetal development); (C) the elderly; (D) individuals with preexisting medical conditions; (E) workers; and (F) members of any other appropriate population identified by the Administrator." TCSA added "effects on fetal development" to clarify the meaning of "pregnant women." Of note is the inclusion of "workers" in the definition.
    • Use, which had not previously been defined, is defined in TCSA as "any utilization of a chemical substance or mixture that is not otherwise covered by the terms manufacture or process and may include -- (A) any composition of the chemical substance with other chemical substances; [or] (B) any group of utilizations determined by the Administrator to be a single use under subsection (b)(2)." The definition specifically notes that relabeling or redistributing a container holding a chemical substance or mixture where no repacking of the chemical substance or mixture occurs does not constitute use of the chemical substance or mixture, which in combination with the definition of "processing" leaves open the question of whether relabeling or redistributing a container is excluded from coverage under the law.
    • TCSA newly defines Importer as "any person who imports a chemical substance or mixture, or any article containing a chemical substance or mixture, for distribution in commerce."
    • The introduced bill includes a subsection 3(b) Determinations, which states "(1) The Administration may determine different forms of a chemical substance with a particular molecular identity to be different chemical substances... based on variations in the substance characteristics. ... (2) The Administrator may determine different uses of a chemical substance or mixture to be the same use for purposes of this Act, based on industry classification systems or factors determined by the Administrator to indicate similarity in use and exposure." TCSA goes on to state, regarding (1), that "[n]ew forms of existing chemicals so determined shall be considered new chemical substances for purposes of this Act." This addition would seem squarely to authorize EPA to determine nanoscale forms of existing chemicals as "new" for TSCA purposes.
  • 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 TCSA and SCA would require manufacturers and processors to submit to EPA a "minimum data set." Importantly, the TCSA imposes this requirement on chemical substances and, seemingly, certain mixtures while the Senate bill limits the requirement to chemicals.
  • 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 TCSA provides the following guidance for EPA to consider in developing the data set rule: the rule shall include information "that the Administrator determines will be useful in conducting safety standard determinations... or carrying out any other provision of this Act, and shall include information on (i) chemical identity; (ii) substance characteristics; (iii) biological and environmental fate and transport; (iv) toxicological properties; (v) volume manufactured, processed, or imported; (vi) intended uses; and (vii) 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." 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 on chemicals and mixtures 18 months after EPA's listing of the substance or mixture on the Section 6(a) priority list, and for chemicals depending on the production volume of the chemical substance (high volumes within 3 years; moderate volumes within 4 years; and low volumes within 5 years of enactment of TCSA). This is a change from the House discussion draft, which would require data on existing chemicals and mixtures within 5 years of enactment. The determinations of high, moderate, or low volumes would be made by the Administrator and, recognizing that EPA has 1 year to establish the minimum data set, the time period available to manufacturers and processors for completing the minimum data set for such chemicals would be reduced by 1 year to 2, 3, and 4 years, respectively. Manufacturers of new chemicals would be required to submit data when submitting the pre-manufacture notice (PMN).Given the requirement that the data set be "useful in conducting safety standard determinations" and the inclusion of the term "toxicological properties" with its broad definition in the required elements of the minimum data set, it is considered unlikely that the Screening Information Data Set (SIDS) would suffice to meet these requirements. The SIDS data set, which was developed by the Organization for Economic Cooperation and Development (OECD) and used by EPA in its High Production Volume Challenge Program, is intended to provide the basis for a screening level assessment of a chemical that can inform as to needed higher tier testing. A "no harm" assessment, on the other hand, seemingly would require something approaching a confirmatory data set for each chemical, such as that required under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Part 158 regulations for pesticide registrations, Tier 3 in EPA's Voluntary Children's Chemical Evaluation Program, or the high volume tier under the European Union's (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. It seems unlikely that, if menus such as these are required as the minimum data set, the allowed time period for developing the data sets will be sufficient. The costs required for such testing would be considerable. If, for example, EPA would determine that the SIDS is adequate for the low volume tier, the estimated cost is approximately $200,000 for that battery, whereas for the high volume tier under REACH, the estimated cost is $900,000 to 1.6 million euros. See Charles M. Auer, Periodic Reporting of Hazard Data, Exposure Information on Existing Chemicals, BNA Daily Env't Rep., Apr. 14, 2010, at B-1, available online. Given the tens of thousands of chemicals potentially at play, the costs are likely to be prohibitive.

     

    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 TCSA would broaden EPA's authority to require additional testing by allowing EPA to: (1) issue orders in addition to rules to require data (TCSA provides for "notice and opportunity for comment," although there is no requirement that EPA consider and deal with the comments); (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) impose penalties or by order impose conditions, including prohibitions on manufacturing, processing, or distribution of any chemical substance or mixture for which minimum data set or testing requirements are not met by a given manufacturer or processor.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.

    Biomonitoring studies. The broad authority in the discussion draft to require companies to conduct biomonitoring studies has been clarified in TCSA Section 4(b)(6) to state that such studies of the public shall be conducted by the Centers for Disease Control and Prevention (CDC) at the expense of the manufacturers and processors of the chemical. TCSA also clarifies that biomonitoring studies of employees may be conducted by the employer in collaboration with the National Institute of Occupational Safety and Health (NIOSH).

  • Section 4 (Testing) -- Requests from Other Federal Agencies for Additional Information or Testing: The TCSA includes a new provision not currently in TSCA that would make explicit the ability of other federal agencies to request that EPA seek information "f 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 an 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 4 (Testing) -- Miscellaneous Observations:
    • The legislative text is unclear whether each manufacturer and processor would be required to submit the minimum data set individually or whether a consortia-based submission would be provided, although Section 34(a)(1)(D) on animal welfare specifically notes forming consortia.
    • Under Section 4(b)(3)(B), the text states that EPA "may" specify test protocols and methodology, leaving open the question whether EPA will so specify and, if not, how the requirement would be enforced.
    • Also the same section notes that EPA may require the submission of preliminary data during the testing time frame. Requiring submission of "preliminary" unaudited data is questionable and possibly unwise.
  • 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 seem to require a PMN from each person who manufactures or processes a new chemical. Currently, TSCA limits the manufacture of a chemical not listed on the Inventory.

     

    The TCSA would change several aspects related to the submission and review of notices on new chemicals and on new uses. First, as noted above, manufacturers and processors would be required to submit a minimum data set when the PMN or new use notice is submitted, unless the minimum data set requirement has already been met for an "equivalent chemical substance" as determined by EPA.

    Second, the PMN requirement is extended to "new mixtures." The operation of this requirement presents a number of issues and questions:

    TCSA 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.

     

    Section 8(a) declarations seem not to be required for all existing mixtures in commerce. Rather, Section 8(a)(1)(B) describes an additional requirement for a declaration from any manufacturer or processor of a mixture determined by the Administrator to have "substance characteristics different from the substance characteristics of the constituent chemical substances, in kind or degree." Thus, the only declarations on existing mixtures are those required as determined by the Administrator. Accordingly, it is not clear how subject entities will identify "new mixtures" subject to PMN requirements, short of EPA explicitly identifying them.

    Third, new use notices are required for new uses as determined by the Administrator under Section 5(a)(2) of TCSA. The new use determinations apply only to chemical substances or mixtures that have received a Section 6(b) safety determination and the new use is either one that was not included in the safety determination or the proposed use will result in manufacture or processing of the chemical or mixture at "significantly increased volume, as determined by the Administrator, above that considered in the safety standard determination."

    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 under Section 5(a)(1)(B) that: "(i) such use is a critical use as determined pursuant to section 6(e); (ii) in the case of a chemical substance or mixture that has not already been determined to meet the safety standard under section 6(b), the chemical substance or mixture meets the safety standard under section 6(b), with or without conditions; or (iii) in the case of a chemical substance or mixture that has already been determined to meet the safety standard under section 6(b) without inclusion of the proposed new use, the chemical substance or mixture continues to meet the safety standard under section 6 for all intended uses including the new use, with or without conditions."

    Thus, to market new chemicals and mixtures under Section 5(a)(1)(B)(ii), manufacturers must satisfy the safety standard at Section 6(b) with or without conditions (seemingly the other provisions are only relevant to new uses, not new chemicals). While the discussion draft specified the standard "not reasonably anticipated to present a risk of injury to health or the environment" in addition to the safety standard, the TCSA would require "a reasonable certainty that no harm will result, including to vulnerable populations" be satisfied before new chemicals or mixtures can be commercialized.

    New uses of existing chemicals, if they are to go into commerce, must either satisfy the Section 6(e) critical use exemption requirements or continue to meet the Section 6(b) safety standard for all uses, including the proposed new use. Insofar as it is difficult to see many chemicals satisfying the Section 6(e) requirements, any new uses of subject existing chemicals will require a redetermination of the safety standard, which, depending on the number and complexity of ongoing uses, could be difficult and complex for EPA to undertake.

    TCSA would also change the timelines for an EPA decision on Section 5(a) notices. Under TSCA, EPA has 90 days to make its decision, although the time period can be extended under Section 5(c). Under TCSA, within 90 days of submission of a PMN and any necessary data, EPA shall determine whether the use is critical (which as discussed above is unlikely to be met under any circumstances) or whether a safety standard determination is required (it would be required for all new chemicals and mixtures not otherwise exempted based, for example, on Section 35 or Section 39 of TCSA, as discussed in the following paragraph). EPA would then have 9 months to complete the safety standard determination. Importantly, the draft bill thus proposes to allow EPA a period of 1 year before it is required to make a safety standard determination on new chemicals or new uses. Failure to meet this deadline is explicitly stated not to satisfy the required finding under Section 5(a)(1)(B) and thus the new chemical or new use would not be able to proceed until the determination has been rendered.

    While it is difficult to see how this timeline can be seen to meet the requirements of a dynamic chemical industry, TCSA includes a few provisions that could be used to avoid delays. In particular, a new chemical or new use that has been approved per the Section 35 requirements as a "safer alternative" is exempt from the requirements of Section 5. In addition, a new Section 39(a) in TSCA provides exemption from Section 5 for chemicals or mixtures based on intrinsic properties. While welcome, it is less than clear that these provisions will prove to be of assistance to a significant fraction of new chemicals, mixtures, or uses. In addition per Section 39(b), EPA is required to publish the chemical identity or the particular use in the Federal Register. This provision has no cross reference to Section 14 and thus CBI protections appear to be denied for such new chemicals or new uses of existing chemicals.

    In the case of an existing chemical or mixture that has not received a safety standard determination, anyone manufacturing or processing such a chemical for a use that has not previously been declared under Section 8(a) or for a use that the particular manufacturer or processor has not previously declared, is required by Section 5(b)(2) to submit the Section 8(a) declaration within 6 months of initiating manufacture, processing, or distribution for that use. Such new uses do not appear to be subject to the Section 5 new use provisions, although they would ultimately be considered in making the existing chemical safety determination under Section 6(b). One question is how this requirement under Section 5(b) relates to the requirement under Section 8(a)(4) for immediate updating of declarations; at a minimum, the requirements seem to be duplicative.

    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:

    1. 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;
    2. a known, probable, or suspected reproductive, developmental, neurological, or immunological toxicant, carcinogen, mutagen, or endocrine disruptor, or has other toxicological properties of concern;
    3. persistent and bioaccumulative;
    4. 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
    5. 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.

    Both the SCA and TCSA include the current TSCA Section 5(h) exemptions for: (1) test marketing purposes; (2) equivalent chemical substances; (3) substances manufactured or processed in small quantities; and (4) substances that exist temporarily as a result of a chemical reaction in the manufacturing or processing of a mixture or another chemical substance, and to which there is no, and will not be, human or environmental exposure. Of these, numbers 1 and 2 are available upon application. Neither the SCA nor the discussion draft includes the current Section 5(h)(4) regulatory exemption provision, meaning that substances currently in commerce based on such exemptions would be subject to PMN, the minimum data set, and other provisions discussed above. The TCSA includes at Section 39(d) a provision regarding prior such regulatory exemptions. Under the TCSA, within 1 year after the date of enactment, EPA would review exemptions granted under TSCA Section 5(h)(4) to determine if they satisfy the requirements regarding "intrinsic properties" under Section 39(a). The prior exemptions will continue in effect "until such date as the Administrator determines, by order, that (1) the exemption is not authorized or not appropriate under this section, at which time the exemption shall cease to be in effect; or (2) the exemption is authorized and appropriate under this section, at which time the Administrator may issue an order to modify or continue in effect the exemption pursuant to subsection (a)."

    While it is useful that TCSA recognizes the fact of Section 5(h)(4) exemptions, the proposed approach involves an EPA determination that "scientific consensus exists that the intrinsic properties of a chemical substance or mixture are such that it does not and would not pose any risk of injury to health or the environment under any current, proposed, or anticipated levels of production, patterns or use, or exposures arising at any stage across the lifecycle." This stringent standard seems likely significantly to limit the applicability of the exemption. Seemingly, water would not qualify and even high molecular weight polymers that currently satisfy the polymer exemption require the use of reactive and often toxic monomers in their production, which would appear to make them ineligible given the lifecycle requirement.

    Under the SCA, for new uses of existing chemicals prior to EPA's completion of a safety determination, no person may manufacture or process the chemical substance without first submitting a binding declaration of current manufacture or processing in the following circumstances: (1) for a use that was not ongoing on the date of enactment of the SCA; (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 on the date of enactment of the SCA. Note that the "the" in provision (3) makes it clear that this requirement applies to each manufacturer or processor.

    For new uses of existing chemicals that meet the safety standard, the SCA would prohibit the manufacture or processing of a chemical substance for a use, at a production volume, or in a manner other than those EPA specified in its safety determination, unless: (1) the manufacturer or processor submits a notice of intention to manufacture or process the substance for the new use, at the new production volume, or in such other manner that is inconsistent with a specified condition or term for such substance, as well as all updates to the minimum data set relevant to the new use, new production volume, or other new manner of manufacturing or processing; (2) the notice indicates that the chemical substance will continue to meet the safety standard if the allowed uses, allowed production volume, or other specified conditions or terms for such chemical substance are revised to encompass the new use or new production volume, or other new manner of manufacturing or processing; and (3) EPA determines that the manufacturer or processor submitting the notice has established that the chemical substance will continue to meet the safety standard if the allowed uses or allowed production volume, or other specified conditions or terms for such substance, are revised to encompass the new use or new production volume or other new manner of manufacturing or processing. Provided these conditions are satisfied, EPA will amend the safety determination to include the new use or new production volume among the allowed uses or production volumes of the chemical substance by that manufacturer or processor.

    Under the SCA, after receiving the notice and supporting data, EPA will have 180 days to determine whether the manufacturer or processor has established that the chemical substance will meet, or continue to meet, the safety standard. EPA may extend this deadline by one or more additional periods not to exceed 12 months in the aggregate. The SCA states that EPA's failure to make a timely determination is not sufficient to satisfy the requirement that the chemical substance will meet, or continue to meet, the safety standard.

    The SCA includes a provision regarding chemical substances exhibiting special substance characteristics. Under the SCA, EPA shall determine by order or rule that a variant of a chemical substance exhibiting one or more special substance characteristics: (1) is a use that is separate from any use of the chemical substance that does not exhibit such special substance characteristics; or (2) is a new chemical substance. In the case of a chemical substance that EPA determines to be a separate use based on its special substance characteristics, the manufacturer or processor shall satisfy such further conditions as EPA establishes, by order or rule.

  • Section 6 -- Development of Priority List for Safety Standard Determinations: While the discussion draft included a provision (Section 33) requiring expedited action for a set of 31 chemicals and categories of chemicals, this provision has been dropped from TCSA and, essentially in its place, establishes an initial priority list of 12 chemicals plus a 7-chemical category of phthalates for which safety standard determinations shall first be made. The initial statutory priority list would include bisphenol A; formaldehyde; n-hexane; hexavalent chromium; methylene chloride; trichloroethylene; vinyl chloride; certain phthalates (benzylbutyl phthalate, dibutyl phthalate, diethylhexyl phthalate, di-isodecyl phthalate, di-isononyl phthalate, di-n-hexyl phthalate, and di-n-octyl phthalate); perchlorate; tetrachloroethylene; tris (1,3-dichloro-2-propyl) phosphate; tris (2-chloroethyl) phosphate; and tris (2,3-dibromopropyl) phosphate. Relative to the list at Section 33 of the discussion draft, newly listed substances include di-isononyl phthalate, di-n-octyl phthalate, and perchlorate. EPA would then have 12 months to update the list, "which shall consist of not fewer than 300 chemical substances." EPA would have discretion in listing these chemicals, based on "available scientific evidence and consideration of their hazard, exposure, or risk relative to other chemical substances, aggregate or cumulative exposure, evidence of exposure to humans including presence in human or animal biological and environmental media including in the workplace, use, volume of manufacture, toxicological properties, persistence, bioaccumulation, or other properties indicating risk." EPA can remove a chemical substance only after a safety determination has been made and must periodically add chemical substances to the list so that the list never has fewer than 300, "until such time as all chemical substances manufactured, processed, or distributed in commerce have been listed, have received a safety standard determination, or have been exempted from the requirement to receive a safety standard 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 TCSA specifically addresses mixtures, stating: "The Administrator may add a mixture to the priority list based on available scientific evidence and the considerations for listing described in paragraph (1)."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 (DOL); Council on Environmental Quality; NIOSH; 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(b) (Safety Standard Determination): The TCSA proposes that EPA apply a safety standard that "takes into account aggregate exposure to a chemical substance or mixture and ensure that, for all intended uses: (i) with regard to public health, there is a reasonable certainty that no harm will result, including to vulnerable populations; and (ii) the public welfare is protected." The TCSA standard differs in several critical ways from that proposed in the discussion draft as the following redline illustrates:

     

    takes into account aggregate and cumulative exposure to a chemical substance or mixture and that provides ensures that, for all intended uses: (i) with regard to public health, there is a reasonable certainty of no harm, including to vulnerable populations, and (ii) protects the public welfare is protected from adverse effects, including effects to the environment.

    Key changes include dropping the need to take into account cumulative exposure, the strengthening of the standard with use of "ensures," and the narrowing provided by "for all intended uses" and the specification regarding public health in applying the "reasonable certainty of no harm" provision. TCSA goes on to require that the Administrator in making determinations "shall 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." The last of these seems to be a general reference to cumulative effects and not a requirement that EPA "consider" the cumulative effects of the specific chemical.

    As in the discussion draft, manufacturers and processors have the burden to prove that the chemical substance or mixture meets the safety standard. While under the discussion draft, EPA would have 6 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, the TCSA provides EPA 30 months to make a determination other than for the statutory list of priority chemicals for which determinations must be made within 18 months. 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.

    The TCSA states that the Administrator will determine whether a chemical substance or mixture meets the safety standard taking into account any existing conditions or controls already in place and whether the intended uses that do not meet the safety standard are critical. It is unclear whether the consideration of the critical uses will be made automatically in the determination process or based on submission of a critical use exemption request. In addition, the Administrator may consider exposures associated with known or foreseeable uses that are not intended uses identified by the manufacturer or processor. This appears to conflict with the safety standard language, which specifies the standard applies for all intended uses.

    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 processors 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.

    TCSA contains a new provision at Section 6(b)(4) relating to Standards for Assessment of Data, which requires that not later than 18 months after enactment, EPA shall, after notice and comment, develop and publish guidance regarding the "use of science in making determinations" under Section 6(b). This guidance is to be revised 5 years after enactment of the law and every 5 years thereafter.

    Under TCSA, if the Administrator fails to meet, publish, or renew determinations by the applicable deadline, the Administrator will promptly publish a notice of such failure in the Federal Register, identifying the chemical substance, noting information gaps that have impeded the determination, prohibiting new manufacture, process, or use of the substance, and requiring manufacturers and processors to provide written notice to the public that a safety standard is pending.

  • Section 6(c) (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 it.With the new safety determinations proposed in the TCSA, 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 not to 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 1 year after publication of that determination, "or as quickly as feasible and in no case later than 3 years after such publication." The text is unclear as to who decides feasibility and what criteria would be used to make such decision. 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 manufacture, processing, commercial use, or disposal; and (6) requiring the development of a risk reduction management plan to achieve a risk reduction specified by EPA.

     

    TCSA would also provide explicit authority to regulate occupational exposure provided the requirement "reflect[s] the industrial hygiene hierarchy of controls." This term is not defined nor is it linked to the Occupational Safety and Health Administration (OSHA) approach that starts with engineering controls. Other available hierarchies of control start with "prevention" approaches.

    It is not clear why, under Section 6(c)(2), where a chemical substance is determined to meet the safety standard with conditions, the first listed option is prohibiting the manufacturing, processing, or distribution of the substance. If it meets the standard with conditions, while a restriction might be appropriate, an out-right ban should not be an option for risk management.

    The SCA includes a provision concerning quality control orders that 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 TCSA authorize the Administrator to issue time limited exemptions from Section 6 restrictions for certain uses. Referred to in the TCSA 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 5 years (renewable for one or more additional 5-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 disrupt the national economy"; is needed to protect a "critical or essential use"; is needed because there is no "feasible safer alternative" for the specified 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 purchaser of a mixture or article containing the chemical substance. The Administrator must provide the public with notice of the exemption. The TCSA only requires that manufacturers and processors provide notice to known commercial purchasers of the chemical substance or mixture.

  • Section 8(a) (Reporting) -- Declaration of Manufacturing or Processing: Both bills propose a new requirement that each manufacturer or processor, within 1 year of enactment, provide a declaration of current manufacturing or processing of a chemical substance. The discussion draft had extended this requirement to mixtures but the scope has been limited in TCSA in a provision (Section 8(a)(1)(B)) allowing EPA to require "additionally" a declaration from any manufacturer or processor of a mixture "determined by the Administrator to have substance characteristics different from the substance characteristics of the constituent chemical substances, in kind or degree." TCSA Section 8(a)(2) added or clarified numerous of the data requirements under the declaration as indicated by the underlined portions in the following: the chemical identity of the chemical substance or mixture; data about where manufacture, processing, and distribution occurs; the number of individuals exposed, and "reasonable estimates" of the number who will be exposed in their places of employment and the duration of exposure; 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 or processor that has not previously been submitted to" EPA regarding physical, chemical, and toxicological properties of the chemical substance or mixture, including the toxicity classification according to the Globally Harmonized System for Hazard Classification; the categories or proposed categories of intended use of each such substance or mixture; the total amount of each substance and mixture manufactured or processed, reasonable estimates of the total amount to be manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use; a description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture; exposure data; any conditions placed on the chemical substance or mixture due to regulation under any federal law or due to voluntary action; and for a processor of a chemical substance, any information indicating that a mixture including the chemical substance has substance characteristics that are different from the substance characteristics of the named chemical substances, in kind or degree.Under TCSA, a manufacturer or processor also can declare that it has permanently ceased, or will permanently cease within 180 days of submission of the declaration, all production, importation, processing, and export of the chemical substance (the discussion draft and SCA did not limit this provision to permanent cessations). Manufacturers and processors would have to update these declarations every 3 years, or immediately when certain information is obtained. TCSA revised the requirements as shown by the redlining: 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 indicating a new 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, or otherwise reasonably relevant to an analysis of whether the chemical substance or mixture meets the safety standard under section 6.

     

    Regarding violations in reporting of declarations, TCSA added enforcement penalty authority and specified that action to prohibit or impose conditions would be taken under Section 6(c). SCA and the discussion draft did not include the enforcement provision.

  • Section 8(c) (Reporting) -- Inventory: While the House discussion draft would require that all chemical substances and mixtures in commerce be compiled and maintained in the Inventory, the SCA would require the Inventory to include each chemical substance that is manufactured or processed in the U.S., as well as new chemicals entering commerce and declarations under the new Section 8(b). TCSA establishes an Inventory consisting of chemical substances and mixtures for which declarations are received under Section 8(a)(2) and new chemicals or mixtures. Neither the TCSA nor the SCA include the provision at current TSCA Section 8(b)(2) concerning Inventory categories (sometimes referred to as "statutory mixtures"). Insofar as both draft bills retain the TSCA Section 26(c) "category" provision, this might provide a means to retain such Inventory categories, although an explicit reference would be helpful. The TCSA would allow EPA 24 months to first publish the list, while the SCA provides EPA only 18 months.
  • Section 8 (Reporting) -- Categorization: The TCSA proposes a new requirement that EPA, no later than 5 years from enactment, publish a list of all chemical substances and mixtures manufactured, processed, or distributed in commerce that "categorizes the chemical substances and mixtures, based on existing information available to the Administrator, based upon health or environmental adverse effects, exposure, or other criteria that the Administrator determine[s] appropriate." The corresponding SCA provision does not include mixtures.
  • Section 8 (Reporting) -- Public Database: The TCSA proposes to establish, no later than 1 year from enactment, a public database that would include chemical information submitted to EPA, and EPA's decisions regarding chemicals. SCA includes a similar provision.
  • The TCSA 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 or immediately upon request of the Administrator," whereas SCA would seemingly require submission by rule.
  • The TCSA would also require, effective 1 year after the date of enactment, that all manufacturers and processors provide, with shipment or promptly thereafter and b

 
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