Summary of the Committee Mark-up of the Safe Chemicals Act of 2011 (S. 847)
I. Overview
On July 25, 2012, the Senate Committee on the Environment and Public Works approved a mark-up of Senator Frank Lautenberg's (D-NJ) Safe Chemicals Act of 2011 (S. 847) in a 10-8 partisan vote. The mark-up was advanced in the form of an amendment to S. 847 by the Committee leadership while in the midst of negotiations with key Republicans on a compromise, bipartisan measure.
Non-governmental organizations (NGOs) and industry alike agree that reforming the Toxic Substances Control Act (TSCA) is in order. While Keller and Heckman LLP does not endorse the mark-up bill, it significantly changes the TSCA debate and is likely to frame future reform discussions. It is the new baseline from which industry will need to work. For example, the mark-up bill would streamline both the new substance notification process and the prioritization process for existing chemicals. It has more targeted information requirements, and places greater emphasis on utilizing existing information. The bill improves the treatment of confidential information.
As amended, the Environmental Protection Agency (EPA) would ostensibly "screen" substances based on available information before requiring the submission of minimum information sets. The amended bill also instructs EPA to create tiers of minimum information sets tailored to chemicals in different stages of the evaluation process. Substances with identical molecular structures could be deemed to be different in this process, based upon a determination that they have special substance characteristics, i.e., nanoparticles.
The amended bill retains a prioritization scheme which directs EPA to focus on assessing those existing chemicals posing the greatest risk.
All of the existing exclusions from TSCA's current definition of a "chemical substance" remain in place -- although the bill would bring FDA-exempt substances back into consideration for purposes of exposure analyses. Notably, the amended bill retains the proposed "reasonable certainty of no harm" standard with its reliance on aggregate and cumulative exposure.
The bill continues to propose new obligations on processors of chemical substances on the order of those required of manufacturers and importers. With respect to the protection of confidential business information, the bill explicitly provides for the protection of the identity of certain chemicals, trade secrets and specific production volumes and customer lists. It also suggests imposing steep civil penalties for frivolous confidentiality claims.
In sum, the Committee mark-up of S. 847 contains a number of interesting provisions that could be retained in any final TSCA Reform legislation. However, significant improvements are still necessary.
II. Key Provisions
A. Declaration of Substances in Commerce & on the TSCA Inventory
The Committee mark-up of S. 847 represents a significant change in the current approach to the TSCA Inventory by dividing it into active and inactive parts and by taking steps to remove certain hazardous existing substances from the Inventory altogether.
Specifically, section 8 of the bill would group substances on the current Inventory as follows:
- Chemical Substances on the Active Inventory – These substances can be manufactured or processed in accordance with the outcome of categorization, prioritization, and safety standard determination.
- Chemical Substances on the Inactive Inventory – These substances require notification and submission of existing data and projected production volumes and customer facilities 30 days prior to manufacture or processing.
- Chemical Substances Removed from the Inventory – These substances cannot be manufactured or processed without following the new chemical notification requirements of section 5.
B. Minimum Information Sets
The bill would require EPA to issue a rule establishing tiered "minimum information sets" for use in evaluating new and existing substances under sections 5 and 6 within 1 year of enactment. Minimum information would need to include information on chemical characteristics, toxicological properties, environmental and biological fate and behavior, exposure and uses. , The bill would require the submission of minimum information sets by both manufacturers and processors for the following purposes:
- Categorizing a new or existing chemical substance as a "substance of very low concern," for which a safety standard determination is required;
- Categorizing substances for which there is insufficient available information;
- Designating Priority Class 1 and 2 substances; and
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Making safety standard determinations and re-determinations for existing substances.
By comparison, submission of a minimum information set by industry is not required for EPA to decide to categorize a chemical as a "substances of very high concern." Under proposed section 5(f), the Agency could require submission of minimum information sets for new substances and new uses of existing substances: (1) prior to and as a condition of categorization (applies only to new substances); (2) as a condition of commencement of manufacture or processing; or (3) as a condition of exceeding a specified manufacturing volume or expanding the use of a substance.
C. Notification, Proposed § 5(b) – New Substances
The bill would add additional procedural and data requirements to the current TSCA premanufacture and significant new use notification provisions under section 5. In addition, notifications would be made available on a publicly accessible Internet site.
The bill would require submission of a notice prior to manufacturing a new chemical substance, or processing a new chemical substance for a use that is critical, paramount to national security or significant to the national economy (i.e., section 6(h) uses). The notice must include a statement that the new chemical substance is likely to meet the safety standard determination, or that it meets the section 6(h) exemption criteria in the case of a processor notification. In addition, the notice must include a certification that the submission is accurate and reliable. In addition, the notice must include all existing information and data required to be submitted under any test rule or order.
Within 90 days of receiving a notice, EPA must assign a new substance to one of four categories:
- Substances of Very High Concern - This category would contain Persistent, Bioaccumulative and Toxic (PBT) and "highly hazardous" substances. Manufacturing and processing of these substances would be prohibited unless the proposed use meets the section 6(h) exemption criteria. The categorization decision can be, but need not be, based on submission of a minimum information set.
- Substances Likely to Meet the Safety Standard - This category would include two sub ctegories, described below. Manufacturing and processing of these substances would be permissible pending the completion of a safety standard determination for uses and under conditions specified by the Agency. Notifiers would have to submit a notice of commencement; others could commence manufacture or processing after these substances are added to the Active Inventory.
- Substances with Insufficient Information - This category would seem to act as a holding bin and a trigger for requiring the minimum information set. EPA would place substances in this category if it determines, based on the available information, that insufficient information exists to place a substance into one of the other categories. Once this occurs, notifiers must submit the minimum information set to allow EPA to properly re-categorize the substance, and the conditions of the new category would apply.
- Substances Unlikely to Meet the Safety Standard - Assignment of substances into this category would be based on available information. Manufacturing and processing of these substances is prohibited unless section 6(h) exemption criteria are met.
EPA's categorization decisions would be generally based on existing information submitted by industry, data derived through modeling, bridging or data obtained from another governmental body, "and any additional information EPA determines is needed."
D. Notification, Proposed § 5(c) – Existing Substances
Manufacture or processing of existing substances that have not undergone a safety standard determination, uses that were not ongoing as of enactment, or significantly increased volumes for existing uses compared to the date of enactment would be deemed "new uses". These new uses would be prohibited unless a person submits what appears to be the equivalent of a Significant New Use Notice (SNUN) under the existing statute, together with any data required under an applicable test rule or order.
In the case of existing substances that have undergone safety standard determinations, new uses that EPA had not determined meet the safety standard similarly would be prohibited unless the person submits a "SNUN", submits relevant updates to the minimum information set, and establishes that the new use will continue to meet safety standard. If a notifier met this showing, EPA would then amend the safety standard determination to include the new use.
E. Prioritization, Proposed § 6
The first steps in prioritization involve assigning thousands of chemicals from the Active Inventory to a "batch" every five years, and then categorizing each chemical in the batch to determine which ones should undergo a safety standard determination. Chemicals categorized as "substances of very high concern" are subject to expedited risk management actions, including the range of actions currently authorized under section 6 of TSCA.
Chemicals categorized as "substances of very low concern," require no further risk management action. The final step involves prioritizing into three different classes, based on agency resources and hazard and exposure potential, those chemicals designated to undergo safety standard determinations. The bill precludes judicial review of EPA's assignment of chemicals to batches, categories or priority classes.
- Batching, Proposed § 6(a
EPA must assign a certain number of chemicals from the Active Inventory to a batch every 5 years until all substances on the Active Inventory have been assigned to a batch. The number of chemicals in a batch will be the number of substances for which Chemical Data Reporting (CDR) reports have been submitted as of the date of enactment. The initial batch must be assigned within 270 days after enactment and contain the substances for which CDR reports have been submitted as of that date, subject to certain exclusions and inclusions based on EPA's determination that an earlier or later evaluation is warranted. For all subsequent batches, EPA will make assignments "in a manner that the Administrator determines reflects the extent to which the chemical substances warrant earlier or later evaluation. - Categorization, Proposed § 6(b)
Within 1 year of enacting the Safe Chemicals Act, EPA must promulgate regulations to establish, among other things, the process and criteria for categorizing batched substances, and prioritizing those that are placed in the category of substances to undergo safety standard determinations. Within 6 months after promulgating these regulations, EPA must publish the category assignments for the initial batch. EPA must make category assignments for each subsequent batch 6 months after designating each subsequent batch, which occurs every 5 years.
EPA must assign each chemical in a batch to one of four categories, which mirror the four categories into which new substances are placed:
- Substances of very high concern - Substances in this category require expedited risk management and include: (a) PBTs or highly hazardous substances for which there is evidence of widespread exposure; (b) substances subject to regulation under sections 6 or 7 as of the date of enactment; and (c) substances subject to a voluntary phase-out. Critically, minimum information sets do not have to be submitted or reviewed prior to assignment of a chemical to this category. Within 18 months of assignment, EPA must impose, by order, use restrictions and other conditions necessary to achieve the "maximum practicable reduction in human or environmental exposure." These restrictions would go into effect within 18 months of EPA issuing the order, subject to a one-time compliance extension of 5 years for "exceptional circumstances." The exceptional circumstances include "a compelling technological need to continue a restricted activity," or "a factor wholly beyond the control of the manufacture or processor preventing compliance."
- Substances of Very Low Concern - These are substances EPA determines have "intrinsic low-hazard properties," based on its review of minimum information sets. EPA can waive the minimum information set requirement if the decision can be made to a high degree of confidence on the available information, or can require information beyond the minimum information set if necessary to address conflicting or ambiguous findings. Although the bill does not define "intrinsic low-hazard properties," it requires EPA consider whether a substance was exempt under TSCA § 5(h)(4) (e.g., the polymer exemption) as of the date of enactment in determining whether a substance meets this condition. Chemicals under this category require no further management action.
- Substances to Undergo Safety Standard Determination - This category includes substances that EPA determines do not fall into categories (1) or (2) above, based on its screening of available information that is sufficiently robust to inform prioritization decisions.
- Substances with Insufficient Information - These are substances for which EPA must require the submission of minimum information sets because it has determined that the available information is insufficient or is not of sufficient quality and reliability to permit an informed categorization decision. The minimum information set must be submitted to EPA within 5 years after enactment for the initial batch, and within 5 years of assigning a chemical to this category for all subsequent batches. After submission of the minimum information set, EPA must either re-categorize the substance with the current batch, or hold it for re-categorization with the next batch (i.e., 5 years later).
The bill also provides for voluntary submission of information by trade associations, voluntary consortia and their members once a chemical is designated to undergo a safety standard determination.
3. Prioritization, Proposed § 6(b)
EPA is required to assign initial and successive batches of chemicals designated to undergo safety standard determinations to priority classes. The Agency must take into account the following criteria when assigning priorities for chemicals:
- Potential impact on human health and the environment;
- Hazard potential, including identification of hazard characteristics by other authoritative entities;
- Potential for exposure; and
- Direct measurements of exposure for a given pathway if available and reliable (in preference to indicators or surrogates).
Only Priority Class 1 chemicals undergo safety standard determinations, but as these are completed, chemicals from the other Priority Classes 2 and 3 may be re-categorized as Priority Class 1 and/or 2.
Priority Class 1 - This class would initially include chemicals that EPA determines warrant near term safety evaluations because they possess relatively greater hazard potential and have more significant or widespread exposure. The bill does not require EPA to base this prioritization on its review of the minimum information set.
Priority Class 2 - This class would contain chemicals of a lower priority than Class 1 chemicals. EPA must require the submission of minimum information sets within 5 years of prioritization to this class if needed to inform reprioritization.
Priority Class 3 - This class would be comprised of chemicals EPA determines can be set aside until safety standard determinations for Priority Class 1 and 2 chemicals are completed or new information warrants reprioritization. Notably, the bill prohibits EPA from requiring the submission of minimum information sets for Class 3 chemicals until they are reassigned to either Class 1 or 2.
III. Safety Standard Determinations, Proposed § 6(d)
Based solely on considerations of human health and the environment, including the health of vulnerable populations, EPA would need to determine whether, for each Priority Class 1 chemical, "there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance."
In making a safety standard determination, the Agency must rely on the best available science consistent with the recommendations of the National Academy of Sciences in its "Science and Decisions" report. The bill requires EPA to communicate its approaches and resulting assessments in a manner that is transparent and understandable to the public and risk managers.
In general, EPA must complete its determination for each substance within 5 years of assigning the substance to Priority Class 1. EPA will apply relevant risk management requirements, which include the full range of actions currently authorized under TSCA § 6, to chemicals with a negative safety standard determination or substances subject to new conditions of use under a positive safety standard determination. Unless exempted for a critical use or on other grounds provided by proposed § 6(h), these requirements go into effect 18 months after the date of determination, with a one-time 5 year extension for a compelling technological need or reason beyond the control of the manufacturer or processor preventing compliance. The bill allows any person to petition EPA to reconsider a safety determination on the grounds of new information or significant changes in exposure.
Finally, proposed section 6 would provide EPA authority to issue orders requiring manufacturers or processors to submit a description of their quality control procedures if the Agency has a reasonable basis to conclude that they are manufacturing or processing a substance in a manner that may present a substantial endangerment to health or the environment. If the quality control procedures are insufficient, EPA may order the manufacturer to recall the product.
IV. Exemptions
A. Exemptions from Notification, Proposed § 5(h) - Intrinsically Safe Substances, Including Certain Polymers
The exemption for intrinsically safe substances would essentially replace the current section 5(h)(4) of TSCA, which forms the basis for the existing polymer exemption, with more rigorous criteria. EPA would be able to issue orders exempting from section 5 notification and data submission requirements those new chemicals for which scientific consensus exists that their intrinsic properties are such that they would not pose any risk of injury to human health or the environmental under any intended or reasonably anticipated levels of production, patterns of use or exposure, at any stage of their lifecycles. This decision cannot be based on findings or assumptions of low human or environmental exposure. Once granted, the exemption remains effective until revoked by order.
The bill does allow industry to rely on current exemptions under TSCA § 5(h)(4), unless and until the Agency determines that such substances do not meet the new, more rigorous exemption criteria. However, for polymers eligible for the current polymer exemption, notices of commencement (NOC) must be submitted. EPA must review these exemptions to determine if they are appropriate within 180 days of enactment.
- Test Marketing Exemption - Manufacturers and processors can apply for this exemption from section 5 notification and data submission requirements, but an NOC is still required.
- Equivalent Substances - Manufacturers and processors can apply for an exemption from section 5 notification and data submission requirements if data has been submitted on an equivalent substance, so long as they provide fair and equitable reimbursement in an amount determined by the EPA or as agreed to by the parties.
- Research and Development - This exemption is the same as the current provision, except an NOC is required.
- Temporary Existence - Manufacturers and processors can also apply for an exemption from section 5 notification and data submission requirements for 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 human or environmental exposure. A NOC is still required.
B. Exemptions from Restrictions, Proposed § 6(h)
The bill essentially retains the exemptions from restrictions in prior versions for uses of very high risk substances that are critical, paramount to national security or essential to the economy.
V. Reporting, Proposed § 8
Revised section 8 would preserve the recently promulgated CDR Rule. However, EPA must amend the rule to significantly expand the types of data required beyond manufacturing, processing and worker exposure information. Specifically, manufactures would also have to submit:
1. A list of health and safety studies known to the manufacturer, and a copy of those studies in its possession or control if not previously submitted to EPA.
2. Physical, chemical and toxicological properties of the substance;
3. Uses, exposure and fate information on the substance; and
4. The name and location of each facility to which substance is sent for subsequent distribution, processing, or use, i.e., a customer list.
In addition, EPA must promulgate a rule imposing periodic reporting requirements on processors of consumer or commercial products, where a substance is intentionally added. Reportable information would include annual volumes processed, products intended for use by children under 15, and the concentration range of the chemical in a product. Manufacturers and processors would also be under a continuous obligation to update this information whenever they become aware of "significant new information" or "significant changes to it." Finally, under section 8(g) EPA could issue a rule or order requiring any person who manufactures, processes, distributes in commerce, uses or disposes a chemical substance, mixture or article containing a substance to maintain records of and report any existing information that would assist EPA in administering the Act. Exemptions could cover small businesses and research and development substances.
VI. Preservation of Confidentiality, Proposed § 14
The current bill amends TSCA §14's Disclosure of Data provisions by creating three categories of information. Except for chemical identity information, and other information that EPA specifies by rule as warranting indefinite protection, protection only extends for a period of up to 5 years, subject to a 5-year renewal.
A. Information Always Eligible for Protection
Upon application to EPA and a certification that the information is not otherwise publicly available, EPA must grant protection to the following information.
- "Precise information" describing the manufacture, processing, or distribution of a chemical substance or mixture;
- Marketing and sales information;
- Information identifying the customers of a manufacturer, processor, or distributor;
- Details of the full composition of a mixture of a particular manufacturer or processor;
- "Precise information" about the use, function, or application of a chemical substance or mixture in a process, mixture, or product of a particular manufacturer or processor; and
- "Precise" production or import volumes of a particular manufacturer, processor, or distributor.
B. Information That May be Eligible for Protection
The category applies only to chemical identities and impurity information. The bill would require that EPA protect chemical identities from disclosure if the applicant makes certain showings. The bill imposes civil penalties of up to $10,000 per violation for willful and wrongful disclosures of protected information by the government or requests for protection by members of industry.
C. Information Never Eligible for Protection
The bill would require EPA to disclose the following information: (1) chemical identities, except those eligible for protection as discussed above; (2) safety standard determinations, including EPA's supporting analyses; (3) most health and safety study data; (4) "general information" describing manufacturing volumes, expressed in ranges, and industrial, commercial, or consumer functions and uses of a substance or mixture; or (5) any information indicating the presence of a chemical in consumer products intended for use, or reasonably expected to be used, by children under 15, if EPA or other authoritative body has determined that the substance is a known or probable reproductive, developmental, neurological, or immunological toxicant, carcinogen, or mutagen, is a PBT; or for which a negative safety standard determination was made.
VII. Testing and Test Samples, Proposed § 4(b)
The bill would eliminate the current findings that EPA must make to issue a test rule. Instead, EPA would be authorized to issue a test rule whenever it determined that data was necessary for making any determination or carrying out any provision of the Act.
A test rule or order could require information above that required in a minimum data set and from manufacturers and processors who are not subject to minimum data set requirements. The process for issuing a test rule or order, and the requirements of obligated parties, are similar to current the current section 4, with two notable exceptions. First, the bill explicitly adds that testing can be required to assess exposure. Second, it adds biomonitoring and environmental monitoring studies as permissible testing methodologies. In addition, the bill would allow heads of other Federal agencies to request that EPA issue a test rule or order or require submission of existing information. Manufacturers and processors would also have to certify all information submitted under a test rule or order.