The TSCA Modernization Act of 2015 would amend the Toxic Substances Control Act to expand the ability of the Environmental Protection Agency to evaluate and regulate toxic chemicals. It would give the EPA further authority to impose fees to regulate chemicals. The House Committee on Energy and Commerce gave this report of the bill upon its introduction on May 27. The bill was passed almost unanimously, with a single opposing vote from Rep. Tom McClintock (R-CA4). McClintock offered this explanation of his vote.
The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Dec 17, 2015.
Frank R. Lautenberg Chemical Safety for the 21st Century Act
This bill amends the Toxic Substances Control Act (TSCA) to revise the process and requirements for evaluating and determining whether regulatory control of a chemical is warranted.
(Sec. 2) The bill shall be administered in a manner that: (1) protects the health of children, pregnant women, the elderly, workers, consumers, the general public, and the environment from the risks of harmful exposures to chemical substances and mixtures; and (2) ensures that appropriate information on chemical substances and mixtures is available to public health officials and first responders in the event of an emergency. The bill shall not displace or supplant common law rights of action or remedies for civil relief.
(Sec. 4) Within two years after the enactment of this bill, the Environmental Protection Agency (EPA) must develop any policies, procedures, and guidance necessary to carry out the bill's requirements with respect to: (1) requesting safety data from manufacturers or processors, (2) prioritizing existing chemicals for evaluation of their risks, (3) reviewing new chemicals or significant new uses of existing chemicals, and (4) conducting safety assessments and safety determinations on whether a chemical meets the safety standard. Those policies, procedures, and guidances must be reviewed every five years and revised as necessary to reflect new scientific developments or understandings. In carrying out these requirements, the EPA must take into consideration information relating to chemicals that is reasonably available.
The EPA must also establish policies, procedures, and guidance for the testing of chemicals which must address how and when the exposure level or exposure potential of a chemical would factor into decisions to require new testing. The EPA may not interpret the lack of exposure information as a lack of exposure or exposure potential to a chemical.
The EPA must inform the public of the schedule and the resources necessary for the completion of each safety assessment and safety determination as soon as practicable after designating a chemical as a high-priority chemical for risk evaluation purposes. A safety assessment is an assessment of the risk posed by a chemical under the conditions of use, integrating hazard, use, and exposure information regarding the chemical. A safety determination is a decision made by the EPA as to whether a chemical meets the safety standard under the conditions of use.
At the beginning of each year, the EPA must publish an annual plan that: (1) identifies the chemical safety assessments and determinations to be completed that year, (2) describes the status of each assessment and determination that has been initiated but not yet completed, and (3) includes an updated schedule for completing assessments and determinations if the schedules have changed. The EPA must make available to the public a summary, and the final version, of each safety assessment and determination. The public must be given an opportunity to comment on each proposed assessment and determination.
The EPA must establish the Science Advisory Committee on Chemicals to provide independent advice and expert consultation to the EPA with respect to the scientific and technical aspects of issues relating to the implementation of this bill.
(Sec. 5) The bill revises requirements on testing chemicals to evaluate their risks.
The bill eliminates a requirement that the EPA must first make a preliminary finding about risks before the EPA can require testing by manufacturers or processors. Instead, the EPA may now require the development of information on chemicals for certain purposes, including the development of information that is necessary for reviewing new chemicals, performing safety assessments or determinations, implementing control actions on chemicals, and establishing the priority of a chemical.
Currently, the EPA is limited to requiring the development of information through a rule. The bill allows the EPA to require the development of information through a consent agreement or an order as well.
In determining testing procedures and related deadlines that are required under rules, agreements, or orders, the EPA must take into consideration: (1) the relative costs of the test protocols and methodologies that may be required, (2) the reasonably foreseeable availability of facilities and personnel required to perform the testing, and (3) applicable deadlines for safety assessments and determinations.
The EPA must minimize, to the extent practicable, the use of vertebrate animals in testing chemicals. To promote the development and timely incorporation of new testing methods that are not based on vertebrate animals, the EPA must: (1) develop a strategic plan to promote the development and implementation of alternative test methods and testing strategies to generate information under TSCA that can reduce, refine, or replace the use of vertebrate animals; and (2) fund and carry out research, development, performance assessment, and translational studies to accelerate the development of those alternative test methods and strategies. The EPA must ensure that the elements in the strategic plan are reflected in the development of testing requirements. Any person who voluntarily develops information under TSCA must first attempt to develop the information by an alternative or nonanimal test method or testing strategy before conducting new animal testing.
The EPA may require the development of information by manufacturers and processors of chemicals and persons that begin to manufacture or process the chemical after the effective date of the rule, testing consent agreement, or order.
The EPA must employ a tiered screening and testing process that uses the results of screening-level tests or assessments of available information to inform the decision as to whether additional tests are necessary. The EPA may require more advanced testing without conducting screening-level testing when other information available to the EPA justifies the advanced testing.
Testing information that is not confidential must be made publicly available.
(Sec. 6) Within a year after enactment of this bill, the EPA must establish a risk-based screening process and criteria for identifying existing chemicals that are a high or low priority for a safety assessment and safety determination.
Within 180 days after enactment, the EPA must publish an initial list of high- and low- priority chemicals. The list must contain at least 10 high-priority chemicals as well as 10 low-priority chemicals. At least five of the high-priority chemicals must be drawn from the TSCA Work Plan (i.e. existing chemicals that the EPA has already prioritized for review). Insofar as possible, at least 50% of all chemicals subsequently identified as high-priority chemicals must be from the Work Plan until all Work Plan chemicals have been designated.
In developing the initial list and in identifying additional high-priority chemicals, the EPA must give preference to: (1) chemicals that, with respect to persistence and bioaccumulation, score high for one, and either high or moderate for the other, pursuant to Work Plan; and (2) chemicals listed in the Work Plan that are human carcinogens that have high acute and chronic toxicity.
In prioritizing and assessing metals and metal compounds, the EPA must use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated March 2007, and may use other applicable information consistent with the best available science.
Within three years after enactment, the EPA must add to the list additional high-priority chemicals sufficient to ensure that at least 20 high-priority chemicals have undergone or are undergoing the safety assessments and determination process, and additional low-priority chemicals sufficient to ensure that at least 20 low-priority chemicals have been designated. Within five years after enactment, these numbers must increase to at least 25 high-priority chemicals and 25 and low-priority chemicals.
In carrying out the prioritization screening process, the EPA must consider chemicals active in commerce during the last 10 years. The EPA may take into consideration inactive chemicals if they: (1) have not been subject to enforceable actions by the EPA to ban or phase out the chemicals and have the potential for high hazard and widespread exposure, or (2) have been subject to enforceable actions by the EPA to ban or phase out the chemicals and there is the potential for residual high hazards or widespread exposures not otherwise addressed by the actions.
Once a safety assessment and determination process is completed for a high-priority chemical, it must be replaced on the high-priority list by another chemical until a safety assessment and determination is completed for all high-priority chemicals.
The EPA must complete the designation of all active substances as high- or low-priority chemicals in a timely manner.
The EPA must publish an annual goal for the number of chemicals to be subject to the prioritization screening process. The EPA must also keep current and publish a list of chemicals: (1) that are being considered in the prioritization process, (2) for which prioritization decisions have been postponed, and (3) that are designed as high- or low-priority chemicals.
The EPA may screen categories of chemicals to ensure an efficient prioritization screening process.
The prioritization screening decision regarding a chemical must consider any hazard and exposure information relating to the chemical that is reasonably available to the EPA.
The EPA must identify a chemical as a high-priority chemical if it has the potential for significant hazard and significant exposure. The EPA may identify a chemical as high-priority if it has the potential for either that hazard or exposure. A chemical must be identified as a low-priority chemical if the EPA has information sufficient to establish that the chemical is likely to meet the safety standard.
Prioritization screening decisions may be postponed for a reasonable period if additional information is needed to establish the priority of a chemical.
If the EPA requests the development or submission of information under the prioritization screening process, the EPA must establish a deadline for submission of the information.
Prioritization screening decisions are subject to public notice and comment.
The EPA may revise a priority designation based on information available to the EPA after the date of the determination. If limited availability of relevant information was a basis in the designation of a chemical as a high-priority chemical, the EPA must reevaluate the prioritization screening of the chemical on receiving that information.
A state must notify the EPA if it proposes or takes administrative action or enacts a law to prohibit or restrict the manufacturing, processing, distribution, or use of a chemical that the EPA has not designated as a high-priority chemical. The EPA must conduct a prioritization screening for that chemical if it: (1) is likely to have significant health or environmental impacts, (2) is likely to have significant impact on interstate commerce, or (3) has been subject to a prohibition or other restriction under a statute or administrative action in two or more states.
If a state makes such restrictions on a high-priority chemical after the EPA's deadline for completing the safety determination expires but before the EPA publishes the safety determination, the state must: (1) notify the EPA, and (2) provide the scientific and legal basis for the action.
The EPA must review the prioritization screening process every five years and modify the process as necessary.
A priority designation for a chemical does not affect the manufacture, processing, distribution, use, or disposal of the chemical or the regulation of those activities.
A manufacturer or processor of an active chemical may request the EPA to prioritize a safety assessment and determination for that chemical upon payment of a fee. A limit is placed on the number of requests that the EPA may grant.
(Sec. 7) The bill modifies the process of reviewing new chemicals and significant new uses of existing chemicals, including by requiring the EPA to make a determination that a new chemical or use is likely to meet the safety standard before it can be commercially manufactured or processed.
The EPA must: (1) conduct an initial review of a premanufacture notice (PMN) for a new chemical or a significant new use of an existing chemical, (2) develop a profile of the relevant chemical and the potential for exposure to humans and the environment, and (3) make any necessary safety standard determinations. The review must be made within 90 days after receiving the PMN, but the EPA may extend that period for a good cause for up to 90 days. Any relevant information available to the EPA must be considered when the EPA evaluates the PMN.
Before the end of the initial review period, the EPA must determine that: (1) the relevant chemical or significant new use is not likely to meet the safety standard, (2) the new chemical or use is likely to meet the standard, or (3) additional information is necessary in order to make a determination.
The EPA may extend the review period of a PMN to allow for the development and submission of additional information.
In selecting among restrictions for chemicals that rank high for persistence and bioaccumulation to ensure that the chemical is likely to meet the safety standard, the EPA must select a restriction to reduce potential exposure to the chemicals to the maximum extent practicable.
(Sec. 8) The bill outlines requirements and deadlines for conducting safety assessments and determinations, and promulgates control measures on chemicals.
The EPA must conduct a safety assessment and make a safety determination for each high-priority chemical. Both must be completed within three years of a high-priority designation. Within two years of completing a negative safety determination, the EPA must promulgate a rule establishing restrictions necessary to ensure the chemical meets the safety standard. The EPA must ban or phase out the chemical if the safety standard cannot be met with restrictions. A ban or phase-out must be implemented in as short a period as practicable.
If there is adequate public justification, the EPA may extend the deadlines for conducting the assessments and determinations and promulgating those restrictions for a reasonable period of time that does not exceed two years.
The EPA must decide if a chemical meets the safety standard or if additional information is required. If additional information is needed, the EPA must: (1) provide an opportunity for interested persons to submit the additional information, and (2) establish a deadline for the submission of the information when it requests the development of the information.
Restrictions for certain persistent and bioaccumulative chemicals must reduce exposure to the chemical to the maximum extent practicable.
When establishing restrictions for chemicals that do not meet the safety standard, the EPA must consider the costs and benefits of the proposed regulatory action and the primary alternatives to those actions, based on reasonably available information. The bill revokes the requirement that the EPA must apply the least burdensome regulatory option to restrict a chemical that warrants regulation.
The EPA may exempt uses of chemicals from restrictions if complying with the restrictions would: (1) harm national security, (2) cause significant disruption in the national economy, or (3) interfere with a critical or essential use for which no technically and economically feasible safer alternative is available. The EPA may also exempt uses of chemicals from restrictions if the chemical provides a substantial benefit to health, the environment, or public safety.
The EPA may not extend deadlines for a high priority chemical listed in the 2014 update of the TSCA Work Plan without adequate public justification that demonstrates that the EPA cannot adequately complete a safety assessment and safety determination, or a final rule, without additional information about the chemical.
(Sec. 10) The bill revises TSCA reporting requirements, including nomenclature requirements for chemicals.
Within 180 days of the enactment of this bill and every ten years thereafter, the EPA must review standards for companies that quality as small manufacturers and processors and update those standards if warranted.
The EPA must categorize chemicals on the TSCA Inventory (chemicals of concern) list as active or inactive.
Any confidential business information (CBI) claims to protect the specific identities of existing, active chemicals on the list from disclosure would need to be reaffirmed and substantiated. The EPA must maintain both a confidential and non-confidential portion of the Inventory.
Within five years of compiling that list of active chemicals, the EPA must establish a plan to review all CBI claims.
(Sec. 13) The bill revises exemption and notice provisions for exports of chemicals that are not likely to meet, or do not meet, the safety standard.
(Sec. 14) The bill expands provisions relating the protection of CBI from disclosure. The bill enumerates certain categories of CBI that is presumed to be protected from disclosure. It also specifies certain CBI that is not protected, including information relating to safety assessments and safety determinations and banned or phased-out chemicals. The bill provides exceptions from CBI protection, including an exemption for sharing CBI information with public health or environmental officials in emergencies. The EPA must develop a request and notification system to expedite access to CBI in emergencies.
EPA protection of disclosure of CBI is limited to 10 years, with extensions of 10 years.
(Sec. 16) The penalty amounts for violations of TSCA are increased. A new criminal penalty is established for violators that knowingly place parties in imminent danger of death or serious bodily injury.
(Sec. 17) The bill amends TSCA to revise requirements related to federal preemption of state statutes or administrative actions to manage risks from chemicals. Subject to exemptions, states may not establish or continue to enforce statutes or administrative actions concerning: (1) testing information on chemicals that is likely to produce the same information required by the EPA; (2) restrictions on the manufacture, processing, or distribution in commerce or use of a chemical, and (3) significant new uses of chemicals.
Federal preemption applies only to: (1) the chemical or categories of chemicals subject to a rule, order, or consent agreement; (2) the hazards, exposures, risks, and the uses or conditions of use of chemicals that are identified by the EPA as subject to review in a safety assessment and included in the scope of the safety determination, or of any rule establishing restrictions necessary to ensure that the chemical meets the safety standard; and (3) the uses of those chemicals that the EPA has specified as significant new uses and for which the EPA has required a significant new use notification.
States are prohibited from adopting new restrictions for a high-priority chemical between: (1) the date on which the EPA defines and publishes the scope of a safety assessment; and (2) the date on which deadline to complete the safety determination expires, or the date on which the EPA publishes the determination, whichever is earlier.
The bill caps the penalties and sanctions available to states at the level available to the EPA. The EPA may not access a penalty for a violation for which a state has already assessed an adequate penalty. If a state has assessed a penalty for a specific violation, the EPA may not assess a penalty for that violation in an amount that would cause the total of the penalties assessed for the violation by the state and the EPA combined to exceed the maximum amount that may be assessed for that violation by the EPA.
The bill preserves certain state requirements, rights, causes of actions, and remedies from being preempted by EPA actions under TSCA. State actions taken before August 1, 2015, or taken under laws in effect on August 31, 2003, are exempted from preemption.
(Sec. 18) The bill revises judicial review under TSCA to permit review in the U.S. Court of Appeals for the District of Columbia Circuit of a designation of a chemical as a low-priority substance.
(Sec. 22) The bill repeals a requirement for the EPA to conduct an indemnification study and a study on classifying, storing, and retrieving information on chemicals.
(Sec. 23) The bill expands the EPA's authority under TSCA to collect fees from chemical manufacturers, importers, or processors.
The EPA must establish a fee on manufactures or processors of certain chemicals to annually defray certain costs of the bill. The amounts generated by the fee must be deposited in the TSCA Implementation Fund established by this bill.
The authority to collect fees is conditioned on continued federal appropriations at a certain level. Fees may not be assessed for a fiscal year unless the amount of appropriations, excluding fees, is at least equal to the amount of appropriations for FY2014.
The EPA's authority to collect fees terminates after 10 years.
(Sec. 24) The EPA's Office of Science and Technology Policy must convene an interagency entity under the National Science and Technology Council with the responsibility to coordinate Federal programs and activities in support of sustainable chemistry.
(Sec. 29) The bill amends the Mercury Export Ban Act of 2008 to extend until January 1, 2019, the date by which a facility in the Department of Energy (DOE) designated for the long-term management and storage of elemental mercury generated within the United States must be operational.
DOE must adjust fees for generators temporarily accumulating elemental mercury if the designated facility is not operational by January 1, 2019. If the facility is not operational by January 1, 2020, DOE must: (1)immediately accept the conveyance of title to all elemental mercury that has accumulated in facilities before that date, (2) pay any applicable federal permitting costs, and (3) store, until the facility is operational, the accumulated mercury.
By January 1, 2017, DOE must, after consultation with the EPA and states, develop guidance on the management and short-term storage of elemental mercury at a specified generator.
The EPA must publish an inventory of mercury supply, use, and trade in the United States by April 1, 2017, and every 3 years thereafter.
Effective January 1, 2020, the export of the certain mercury compounds is prohibited.
(Sec. 30) The bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to: (1) develop criteria for the designation of potential cancer clusters; and (2) develop, publish, and periodically update guidelines for investigating potential cancer clusters. While investigating these clusters, HHS may prioritize certain potential cancer clusters based on the availability of resources.