Frank R. Lautenberg Chemical Safety for the 21st Century Act

Bill: 114-hr-2576
Sponsor: full_name: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-26
Policy area: Environmental Protection
Subjects: Administrative law and regulatory procedures

Business records

Congressional oversight

Environmental Protection Agency (EPA)

Environmental health

Environmental regulatory procedures

Federal preemption

Freedom of information

Government information and archives

Government trust funds

Hazardous wastes and toxic substances

Health facilities and institutions

Health technology, devices, supplies

Long-term, rehabilitative, and terminal care

Nursing

Rural conditions and development

State and local government operations

Telecommunication rates and fees

User charges and fees
Latest action: action_date: 2016-06-22
text: Became Public Law No: 114-182.

Summaries:
action_date: 2015-05-26
action_desc: Introduced in House
text: <p><b>TSCA Modernization Act of 2015</b></p> <p> This bill amends the Toxic Substances Control Act (TSCA) to revise regulations on chemicals. TSCA's scope is revised by requiring the Environmental Protection Agency (EPA) to regulate chemicals so that they no longer present unreasonable risks of injury to health or environment instead of requiring the EPA to provide adequate protection against those risks using the least burdensome requirements.</p> <p> The EPA must conduct and publish a risk evaluation for a chemical if: (1) the EPA determines it may present an unreasonable risk of injury to health or the environment, or (2) a manufacturer of a chemical requests an evaluation. The EPA must initiate 10 or more risk evaluations in each fiscal year. The EPA is authorized to require testing on a chemical when it is necessary to conduct an evaluation.</p> <p> If an evaluation determines a chemical will pose an unreasonable risk, the EPA must issue a risk management rule for the chemical. The bill establishes deadlines for conducting and publishing evaluations as well deadlines for publishing risk management rules. </p> <p> The EPA may grant exemptions from risk management requirements for a specific use of a chemical if: (1) the requirement is not cost-effective with respect to that use; and (2) the specific use is a critical or essential use, or the requirement would significantly disrupt the national economy, national security, or critical infrastructure.</p> <p> The EPA must: (1) publish a list of certain persistent, bioaccumulative, and toxic (PBT) chemicals; (2) designate certain chemicals as PBT chemicals of concern; and (3) promulgate rules with respect to those designated PBTs to reduce likely exposure to the extent practicable.</p> <p> This bill revises requirements concerning the disclosure of confidential business information, preemption of state law, fees to defray the cost of administering TSCA, and scientific standards and evidence.</p>

action_date: 2015-06-23
action_desc: Passed House amended
text: <p><b>TSCA Modernization Act of 2015</b></p> <p> 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. </p> <p> (Sec. 3) The Environmental Protection Agency (EPA) must require testing of a chemical when it is necessary to conduct a risk evaluation for that chemical. The EPA's current authority to require by rule the development of information about chemicals is expanded to also include development of information through orders or consent agreements. </p> <p> (Sec. 4) The TSCA's scope is revised by requiring the EPA to regulate chemicals so that they no longer present or will present an unreasonable risk of injury to health or the environment, instead of requiring the EPA to provide adequate protection against those risks using the least burdensome requirements. Further, a chemical may not present an identified unreasonable risk to a potentially exposed subpopulation (a group in the general population likely to be at greater risk than the general population of adverse health effects from exposure to a chemical substance).</p> <p> A rule restricting or prohibiting the manufacturing, processing, or distribution of a chemical will no longer have to be based on a finding that there is a reasonable basis to conclude a chemical poses an unreasonable risk.</p> <p> The EPA must conduct a risk evaluation for a chemical to determine if it presents or will present an unreasonable risk of injury to health or the environment.</p> <p> The EPA may restrict or prohibit a chemical only if it determines through a risk evaluation, without consideration of costs or other non-risk factors, that the chemical presents an unreasonable risk to health or the environment.</p> <p> The EPA must conduct and publish the results of a risk evaluation for a chemical if: (1) it determines that the chemical may present an unreasonable risk of injury because of potential hazard and a potential route of exposure under the chemical's intended conditions of use, or (2) a manufacturer requests an evaluation. A chemical's intended conditions of use means the circumstances under which a chemical is intended, known, or reasonably foreseeable to be manufactured, processed, distributed, and disposed of.</p> <p> The EPA may, without making a determination that a chemical presents an unreasonable risk, conduct and publish the results of a risk evaluation for a chemical that is listed in the TSCA Work Plan for Chemical Assessments (i.e., existing chemicals that the EPA has already prioritized for review).</p> <p> In conducting a risk evaluation, the EPA must: </p> <ul> <li> integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical;</li> <li> not consider information on cost and other factors not directly related to health or the environment;</li> <li> take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical;</li> <li> describe the weight of the scientific evidence for identified hazard and exposure;</li> <li> consider whether the weight of the scientific evidence supports the identification of doses of the chemical below which no adverse effects can be expected to occur; and</li> <li> ensure that the costs to the EPA of conducting the risk evaluation are paid for by the manufacturer when an evaluation is requested by a manufacturer.</li> </ul> <p>The bill establishes deadlines for the EPA to conduct risk evaluations. The EPA must conduct and publish a risk evaluation within three years of: (1) determining that a chemical presents an unreasonable risk, or (2) beginning a risk evaluation on the TSCA Work Plan. The EPA must conduct and publish a risk evaluation within two years when the risk evaluation is requested by a manufacturer.</p> <p>If the EPA receives more requests from manufacturers for risk evaluations than the EPA has resources to conduct by the deadline, it must: (1) initiate risk evaluations that exceed its allotted resources as soon as resources for the evaluations are available, and (2) not collect fees from a manufacturer for an evaluation until it initiates the evaluation.</p> <p>If the EPA determines that a chemical will pose an unreasonable risk based on an evaluation, the EPA must finalize a risk management rule for the chemical within two years of the publication of the evaluation. If the EPA determines that additional information is necessary to make a risk evaluation determination, the EPA may extend the deadline. The deadline may not be extended to a date that is later than: (1) 90 days after receipt of the additional information, or (2) two years after the deadline being extended.</p> <p> The public must be given an opportunity to comment on a determination that a chemical does not and will not present an unreasonable risk. </p> <p> The EPA must initiate 10 or more risk evaluations in each fiscal year.</p> <p> In promulgating a risk management rule, the EPA must impose requirements that are cost-effective, unless additional or different requirements are necessary to protect against the identified risk. The EPA, in deciding whether to prohibit or substantially restrict a specific use of a chemical and in setting an appropriate transition period for the restrictive action, must determine whether a technically and economically feasible alternative to a chemical that benefits health or the environment will be reasonably available as a substitute when the proposed prohibition or restriction takes effect. </p> <p> The EPA must apply prohibitions and restrictions to articles containing chemicals only to the extent necessary to protect against the identified risk.</p> <p> A risk management rule must provide for a reasonable transition period. The EPA may not consider costs or other non-risk factors when deciding whether to initiate a risk management rule.</p> <p> The EPA may grant exemptions from risk management requirements for a specific use of a chemical for up to five years if: (1) the requirement is not cost-effective with respect to that use; and (2) the specific use is a critical or essential use, or the requirement would significantly disrupt the national economy, national security, or critical infrastructure. The exemption period may be renewed for additional five-year periods. The EPA must impose conditions on any use for which an exemption is granted to reduce risk from the chemical to the greatest extent feasible.</p> <p> Within nine months after enactment of this Act, the EPA must publish a list of chemicals that the EPA has a reasonable basis to conclude are persistent, bioaccumulative, and toxic (PBT) chemicals, excluding any chemical that is a metal, a metal compound, or a chemical already regulated under TSCA. Within two years after enactment, the EPA must designate as a PBT chemical of concern each chemical on that list that: (1) has certain persistence and bioaccumulation scores, and (2) is likely to be exposed to the general population or vulnerable subpopulations. Within two years after the designation of a PBT chemical of concern, the EPA must promulgate a rule to reduce likely exposure to such chemicals of concern to the extent practicable.</p> <p> (Sec. 5) In making a determination that it is in the public interest for the EPA to take action under Title I of TSCA with respect to a chemical rather than under another law, the EPA must consider the relevant risks, and compare the estimated costs and efficiencies of the action to be taken under Title I and an action to be taken under other law to protect against that risk.</p> <p> (Sec. 6) The bill revises requirements concerning the protection from disclosure of confidential business information (CBI) submitted under TSCA.</p> <p> CBI may be disclosed to state, local, or tribal government officials upon the request of such officials for the purpose of the administration or enforcement of a law. CBI must be disclosed upon request to: (1) a health or environmental professional employed by a federal or state agency in response to an environmental release, or (2) a treating physician or other health care professional to assist in the diagnosis or treatment of one or more individuals.</p> <p> The authorization under TSCA to disclose certain data from health and safety studies does not include authorization to release data that discloses formulas (including molecular structures) for a chemical whose CBI protections have been justified to the EPA.</p> <p> The EPA's designations of information as CBI expire after 10 years, unless the manufacturer, processor, or distributor reasserts in writing a claim to protect CBI.</p> <p> Any person who receives protected CBI information as permitted under TSCA must use the information only for the purposes for which it was obtained. Further, recipients of protected CBI information may not disclose that information to any person not authorized to receive it.</p> <p> (Sec. 7) The bill revises TSCA to expand federal preemption of state statues or administrative actions to manage risks from chemicals. </p> <p> Subject to exemptions granted to states by the EPA, states may not establish or continue in effect any regulation to protect against exposure to a chemical under the intended conditions of use once the EPA has published a final determination that a chemical will not present an unreasonable risk of injury to health or the environment under those conditions.</p> <p> States may not assess a penalty for a specific violation of TSCA if the EPA has already assessed a penalty for that violation. 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 federal and state penalties to exceed the maximum amount that may be assessed for that violation under TSCA. </p> <p> State actions taken before August 1, 2015, under a state requirement restricting a chemical, or actions taken pursuant to any state laws in effect on August 31, 2003, are exempt from federal preemption, unless an EPA action or determination under Title I of TSCA conflicts with the state action.</p> <p> The bill provides that nothing in TSCA shall be construed to preempt or affect either federal or state tort or contract law. </p> <p> (Sec. 8) This bill revises TSCA provisions concerning accessing fees on chemical manufacturers, importers, or processors.</p> <p> The bill: (1) replaces the cap on fees for data submission with a requirement that fees be sufficient and no more than reasonably necessary; (2) establishes the TSCA Service Fee Fund that may be used by the EPA for administering the provisions of law for which the fees were collected; and (3) requires reports every two years on fee income and disbursements, as well a TSCA Service Fee Fund audit every year. User fees must be deposited into the Fund. </p>  <p> The EPA's decisions concerning testing and regulating chemicals must be based on the weight of scientific evidence. </p> <p> The EPA must: (1) develop any policies, procedures, and guidance that are necessary to carry out this bill within two years, (2) review and revise them as necessary every five years to reflect new scientific developments or understandings; and (3) report on its capacity to conduct and publish risk evaluations and to issue related rules.</p>

action_date: 2015-12-17
action_desc: Passed Senate amended
text: <p><b>Frank R. Lautenberg Chemical Safety for the 21st Century Act </b></p> <p>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. </p> <p>(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. </p> <p>(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. </p> <p>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. </p> <p>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. </p> <p>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. </p> <p>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. </p> <p>(Sec. 5) The bill revises requirements on testing chemicals to evaluate their risks. </p> <p>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. </p> <p>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.</p> <p>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.</p> <p>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. </p> <p>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. </p> <p>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. </p> <p>Testing information that is not confidential must be made publicly available. </p> <p>(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. </p> <p>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. </p> <p>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. </p> <p>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.</p> <p>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. </p> <p>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. </p> <p>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. </p> <p>The EPA must complete the designation of all active substances as high- or low-priority chemicals in a timely manner. </p> <p>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. </p> <p>The EPA may screen categories of chemicals to ensure an efficient prioritization screening process. </p> <p>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. </p> <p>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. </p> <p>Prioritization screening decisions may be postponed for a reasonable period if additional information is needed to establish the priority of a chemical. </p> <p>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. </p> <p>Prioritization screening decisions are subject to public notice and comment. </p> <p>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. </p> <p>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. </p> <p>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.</p> <p>The EPA must review the prioritization screening process every five years and modify the process as necessary. </p> <p>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. </p> <p>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. </p> <p>(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. </p> <p>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. </p> <p>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. </p> <p>The EPA may extend the review period of a PMN to allow for the development and submission of additional information. </p> <p>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. </p> <p>(Sec. 8) The bill outlines requirements and deadlines for conducting safety assessments and determinations, and promulgates control measures on chemicals. </p> <p>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. </p> <p>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. </p> <p>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. </p> <p>Restrictions for certain persistent and bioaccumulative chemicals must reduce exposure to the chemical to the maximum extent practicable. </p> <p>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. </p> <p>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. </p> <p>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.</p> <p>(Sec. 10) The bill revises TSCA reporting requirements, including nomenclature requirements for chemicals. </p> <p>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.</p> <p>The EPA must categorize chemicals on the TSCA Inventory (chemicals of concern) list as active or inactive. </p> <p>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. </p> <p>Within five years of compiling that list of active chemicals, the EPA must establish a plan to review all CBI claims.</p> <p>(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. </p> <p>(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.</p> <p>EPA protection of disclosure of CBI is limited to 10 years, with extensions of 10 years.</p> <p>(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. </p> <p>(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. </p> <p>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.</p> <p>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.</p> <p>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.</p> <p>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.</p> <p>(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.</p> <p>(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. </p> <p>(Sec. 23) The bill expands the EPA's authority under TSCA to collect fees from chemical manufacturers, importers, or processors. </p> <p>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. </p> <p>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. </p> <p>The EPA's authority to collect fees terminates after 10 years. </p> <p>(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.</p> <p>(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. </p> <p>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. </p> <p>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. </p> <p>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.</p> <p>Effective January 1, 2020, the export of the certain mercury compounds is prohibited.</p> <p>(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. </p>

action_date: 2016-06-22
action_desc: Public Law
text: <p><b>Frank R. Lautenberg Chemical Safety for the 21st Century Act</b></p> <p> TITLE I--CHEMICAL SAFETY</p> <p> This bill amends the Toxic Substances Control Act (TSCA) to revise the process and requirements for evaluating and determining whether regulatory control is warranted for manufacturing, distributing, processing, using, and disposing of chemicals. (For purposes of TSCA, the term &ldquo;chemicals&rdquo; does not include food, drugs and cosmetics.) The bill revises several provisions in TSCA, including those relating to: (1) chemical testing; (2) review and regulation of new chemicals, new uses of existing chemicals, and existing chemicals; (3) information reporting; (4) confidential business information (CBI); (5) preemption of state regulations; and (6) fees.</p> <p> (Sec. 4) The bill revises TSCA requirements on testing chemicals and gives the Environmental Protection Agency (EPA) additional testing authority, including by giving the EPA the authority to develop new information for: (1) evaluating unreasonable risks to human health and the environment, (2) prioritizing the risk evaluations, and (3) implementing risk management control actions. The bill also allows the EPA to require the development of information through a consent agreement or an order as well. Currently, the EPA is limited to requiring the development of information through a rule. </p> <p> When developing new information, 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. </p> <p> The EPA must: (1) reduce and replace the use of vertebrate animals in testing chemicals to the extent practicable and when scientifically justified, (2) develop a strategic plan to promote alternative test methods and strategies that reduce or replace vertebrate animals testing; and (3) 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 test method or strategy before conducting new vertebrate animal testing.</p> <p> (Sec. 5) The bill modifies the process of reviewing new chemicals and significant new uses of existing chemicals for unreasonable risks to human health or the environment. The EPA must review new chemicals or significant new uses of existing chemicals, make one of three determinations with respect to those chemicals, and take required risk management control actions.</p> <p> The EPA must affirmatively make determinations before those chemicals may be manufactured or processed. During the review, the EPA: (1) may not consider costs or other nonrisk factors; and (2) must consider subpopulations that may be at a greater risk than the general population of adverse health effects from exposure to a chemical, such as infants, children, pregnant women, workers, or the elderly (potentially exposed or susceptible subpopulation).</p> <p> The three risks determinations that the EPA may make are as follows. First, the EPA may determine that the new chemical or new use presents an unreasonable risk of injury to human health or the environment. If the EPA makes this determination, then it must take action to protect against the risk by issuing a rule, such as a rule that limits or prohibits the amount of the chemical that may be manufactured, processed, or distributed.</p> <p> Second, the EPA may determine that: (1) the information available to the EPA is insufficient to permit a reasoned evaluation of a new chemical or new use; (2) in the absence of sufficient information, the chemical may present an unreasonable risk; or (3) the chemical will be produced in substantial quantities and it either enters (or may be anticipated to enter) the environment in substantial quantities or there is or may be significant or substantial human exposure to the chemical. If the EPA makes any of those determinations, then it must: (1) issue an order prohibiting or limiting the manufacture, processing, distribution, use or disposal of the chemical in order to protect against an unreasonable risk of injury, and (2) consider issuing a significant new use rule or explain why the EPA will not be issuing the rule.</p> <p> Third, the EPA may determine that the chemical is not likely to present an unreasonable risk. In this case, the chemical may be manufactured or processed.</p> <p> If the EPA fails to make a determination by the applicable review period, then the EPA must refund applicable fees to manufactures and processors that notified the EPA of their intention to manufacture or process a chemical.</p> <p> (Sec. 6) The bill: (1) revokes the requirement that the EPA must apply the least burdensome regulatory option to restrict a chemical that warrants regulation, (2) establishes a process for conducting and prioritizing risk evaluations for chemicals, and (3) revises requirements concerning risk management control actions.</p> <p> Within a year after enactment of this bill, the EPA must establish a risk-based screening process and criteria for designating chemicals as high priority chemicals for risk evaluations or low priority chemicals for which risk evaluations are not warranted at the time. The process must include consideration of chemicals&rsquo;: (1) hazard and exposure potential (including persistence and bioaccumulation, potentially exposed or susceptible subpopulations, and storage near significant sources of drinking water); (2) conditions of use; and (3) volume. The conditions of use means the circumstances under which a chemical is intended, known, or reasonably foreseen to be manufactured, processed, or disposed of, or used.</p> <p> The EPA must designate a chemical as high priority if it concludes that the chemical may present an unreasonable risk of injury to human health or the environment because of a potential hazard and a potential route of exposure under the chemical&rsquo;s conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation. If a chemical does not meet the high priority standard, then the EPA must designate it as a low priority chemical. The EPA, in making these designations, may not consider costs or other nonrisk factors.</p> <p> The EPA must ensure that the time required for making a priority designation be at least nine months and no more than one year. If at the end of that period the EPA does not have sufficient information on a chemical to support a low priority designation, it must designate a chemical as high priority. The bill establishes deadlines for requirements under the risk-based screening process.</p> <p> The EPA must: (1) initiate risk evaluations for all high priority chemicals; and (2) designate at least one high priority chemical upon the completion of each risk evaluation, other than a risk evaluation conducted upon the request of a manufacturer. </p> <p> The EPA may revise a low priority designation for a chemical based on information provided to the EPA about the chemical.<br> Within 180 days after enactment, the EPA must ensure that risk evaluations are being conducted on 10 chemicals from the 2014 update to the TSCA Work Plan for Chemical Assessments (i.e. existing chemicals that the EPA has already prioritized for review). </p> <p> Within three and one half years after enactment, the EPA must ensure that: (1) risk evaluations are being conducted on at least 20 high priority chemicals, and (2) designations of low priority chemicals have been made for at least 20 chemicals. At least at least 50% of all chemicals on which risk evaluations are being conducted must be drawn from the 2014 update.</p> <p> The EPA must: (1) continue to designate priority chemicals in accordance with the deadlines established by the bill; and (2) conduct the evaluations to determine whether a chemical presents an unreasonable risk of injury to human health or the environment, including an unreasonable risk to a potentially exposed or susceptible subpopulation. Costs or other nonrisk factors may not be considered in the evaluations.</p> <p> In designating high-priority substances, the EPA must give preference to: (1) chemicals listed in the 2014 update as having a persistence and bioaccumulation score of three, and (2) chemicals listed in the 2014 update that are known human carcinogens and have high acute and chronic toxicity. </p> <p>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, or a successor document that addresses metals risk assessment and is peer reviewed by the EPA&rsquo;s Science Advisory Board.</p> <p> The scope of the risk evaluation must be published within six months after initiation. </p> <p> Manufacturers may request and pay for risk evaluations for chemicals. Risk evaluations requested by manufacturers must account for at least 25% of ongoing evaluation (if sufficient requests are made) and no more than 50% of ongoing evaluations. The EPA must give preference to the requests if they involve a chemical that has had a significant impact on interstate commerce due to state regulations of the chemical.</p> <p> The bill establishes requirements for the EPA to follow when conducting risk evaluations, including: (1) integrating and assessing available information on hazards and exposures information; (2) describing whether aggregate or sentinel exposures to a chemical substance under the conditions of use were considered, and the basis for that consideration; and (3) describing the weight of the scientific evidence for the identified hazard and exposure.</p> <p> The EPA must complete risk evaluations as soon practicable, but no later than three years after the evaluation was initiated. The deadline may be extended for six months.</p> <p> If the EPA determines from the risk evaluation process that a chemical presents an unreasonable risk of injury to health or the environment, the EPA must: (1) propose a rule presenting risk management control options within a year of the risk evaluation being published, and (2) issue the rule within two years of the risk evaluation. The deadlines may be extended under certain circumstances. In selecting risk management options, the EPA must consider, to the extent practicable, the effects and magnitude of exposure, the benefits of the chemical, the reasonably ascertainable economic consequences of the rule, and the costs and benefits of the regulatory action and technically and economically feasible alternatives to that action. The EPA must apply restrictions to a chemical only to the extent necessary to address the identified risks from exposure to the chemical. The bill establishes certain exemptions and limitations from control actions.</p> <p> The bill: (1) revises provisions concerning administrative procedures and the effective dates of chemical regulation; and (2) establishes a procedure requiring expedited regulatory action, to the extent practicable, that reduces exposure to certain persistent, bioaccumulative, and toxic chemicals. </p> <p> (Sec. 8) The bill revises TSCA reporting requirements, including requirements concerning: (1) chemical nomenclature (systems for naming terms with respect to chemicals); and (2) small manufacturers and processors. <br> Within three years of enactment, the EPA must enter into negotiated rulemaking for limiting reporting requirements for inorganic byproducts that are recycled, reused, or reprocessed. </p> <p> The EPA must issue a rule within a year of this bill&rsquo;s enactment that requires manufacturers, and may require processors, to notify the EPA within 180 days of enactment that a chemical has been manufactured or processed during the last 10 years. The EPA must use information collected from the manufacturers and processors to categorize chemicals on the TSCA Inventory (existing chemicals of concern) list as active or inactive in commerce. 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. The bill outlines a process for reviewing those CBI claims. One year after compiling the list of active chemicals, the EPA must issue a rule that establishes a five-year plan to complete the review of CBI chemical identity claims on active chemicals.</p> <p> The EPA must complete the review process in five years, but the EPA may extend the deadline by two years. The EPA must keep the designations of active and inactive chemicals on the list current.</p> <p> By April 1, 2017, and every three years thereafter, the EPA must publish in the Federal Register an inventory of the supply, use, and trade of elementary mercury and mercury. The EPA must: (1) identify manufacturing processes or products that intentionally add mercury, and (2) recommend actions to achieve further reductions in mercury use.</p> <p> (Sec. 9) This bill revises TSCA provision concerning relationships to other federal laws, including by requiring the EPA to provide information to relevant agencies when it obtains information about chemical exposures or releases that may be prevented or reduced under another federal law.</p> <p> (Sec. 10) The bill establishes a prohibition on the exportation of certain mercury compounds as of January 1, 2020. However, the prohibition does not ban the exportation of mercury to member countries of the Organization for Economic Co-operation and Development for environmentally sound disposal. Individuals may petition the EPA to prohibit a mercury compound.</p> <p> 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.</p> <p> (Sec. 11) The bill revises and expands provisions relating the protection of CBI from disclosure. The bill enumerates certain categories of CBI that is presumed to be protected from disclosure. </p> <p> The bill specifies certain CBI that is not protected, including information about banned or phased-out chemicals.</p> <p> The bill establishes substantiation requirements that must be met in asserting claims for CBI protection. However, certain information is not subject to substantiation requirements.</p> <p> 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 nonfiction system to expedite access to CBI in emergencies.</p> <p> EPA protection of disclosure of CBI is limited to 10 years, with extensions of 10 years.</p> <p> The bill establishes: (1) requirements governing the EPA&rsquo;s review of CBI claims, and (2) criminal penalties for individuals who willfully discloses CBI, unless the individual is a medical professional who discloses the information for the treatment of a patient.</p> <p> (Sec. 13) 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) information for testing chemicals for unreasonable risks if the information is likely to produce the same information required by the EPA; (2) restrictions on, or penalties for, the manufacture, processing, or distribution in commerce or use of a chemical if the EPA determined that the chemical does not present an unreasonable risk of injury to human health or the environment, and (3) requirements for a chemical that is already subject to requirements governing significant new uses of chemicals. </p> <p> The bill caps the penalties and sanctions available to states at the level available to the EPA. A state may not access a penalty for a violation for which the EPA 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.</p> <p> The bill sets forth effective dates after which states may not establish statues, criminal penalties, or administrative actions creating prohibitions or other restrictions concerning high priority chemicals. Preemption begins when the EPA defines the scope of a risk evaluation and ends on the earlier date between: (1) the expiration of the deadline for completing the risk evaluation, or (2) the publication of the risk evaluation.</p> <p> 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 22, 2016, or taken under state laws in effect on August 31, 2003, are exempted from preemption.</p> <p> (Sec. 14) The bill revises judicial review under TSCA, including by permitting 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.</p> <p> Low priority determinations may be challenged within 60 day of publication.</p> <p> (Sec. 17) The bill revises and expands the EPA's authority under TSCA to collect fees from chemical manufacturers or processors to defray the costs of the bill. The amounts generated by the fee must be deposited in the TSCA Service Fee Fund established by this bill. The EPA's authority to collect fees terminates after 10 years. </p> <p> At the beginning of each year, the EPA must publish an annual plan and report concerning risk evaluations.</p> <p> (Sec. 21) The bill amends the Public Health Service Act to provide for the investigation of potential cancer clusters.</p> <p> Title II -- RURAL HEALTHCARE CONNECTIVITY</p> <p> <b>Rural Healthcare Connectivity Act of 2016 </b></p> <p> (Sec. 202) This bill amends the Communications Act of 1934 to include skilled nursing facilities among the types of health care providers who may request from a telecommunications carrier under the Universal Service Fund the necessary telecommunications and information services to serve persons who reside in rural areas at rates that are reasonably comparable to rates charged for similar services in urban areas.</p>

tv_txt: I 114th CONGRESS 1st Session H. R. 2576 IN THE HOUSE OF REPRESENTATIVES May 26, 2015 Mr. Shimkus (for himself, Mr. Upton , Mr. Pallone , and Mr. Tonko ) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To modernize the Toxic Substances Control Act, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the TSCA Modernization Act of 2015 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Definitions. Sec. 3. Testing of chemical substances and mixtures. Sec. 4. Regulation of hazardous chemical substances and mixtures. Sec. 5. Relationship to other Federal laws. Sec. 6. Disclosure of data. Sec. 7. Effect on State law. Sec. 8. Administration of the Act. Sec. 9. Conforming amendments. 2. Definitions Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) by redesignating paragraphs (7) through (14) as paragraphs (8) through (10) and (12) through (16), respectively; (2) by inserting after paragraph (6) the following: (7) The term intended conditions of use means the circumstances under which a chemical substance is intended, known, or reasonably foreseeable to be manufactured, processed, distributed in commerce, used, and disposed of. ; and (3) by inserting after paragraph (10), as so redesignated, the following: (11) The term potentially exposed subpopulation means a group of individuals within the general population who, due to either greater susceptibility or greater potential exposure, are likely to be at greater risk than the general population of adverse health effects from exposure to a chemical substance. . 3. Testing of chemical substances and mixtures Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (A)(iii), by striking ; or and inserting a semicolon; (B) in subparagraph (B)(iii), by striking ; and and inserting ; or ; and (C) by adding at the end the following: (C) testing of a chemical substance is necessary to conduct a risk evaluation under section 6(b); and ; and (2) in the matter following subsection (a)(2), by inserting , order, or consent agreement after by rule . 4. Regulation of hazardous chemical substances and mixtures (a) Scope of regulation Section 6(a) of the Toxic Substances Control Act ( 15 U.S.C. 2605(a) ) is amended— (1) by striking finds that there is a reasonable basis to conclude and inserting determines under subsection (b) ; (2) by inserting or designates a chemical substance under subsection (i)(2), before the Administrator shall by rule ; and (3) by striking to protect adequately against such risk using the least burdensome requirements and inserting so that the chemical substance or mixture no longer presents or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulation . (b) Risk evaluations Section 6(b) of the Toxic Substances Control Act ( 15 U.S.C. 2605(b) ) is amended to read as follows: (b) Risk evaluations (1) In general The Administrator shall conduct risk evaluations pursuant to this subsection to determine whether or not a chemical substance presents or will present, in the absence of requirements under subsection (a), an unreasonable risk of injury to health or the environment. (2) Applying requirements The Administrator shall apply requirements with respect to a chemical substance through a rule under subsection (a) only if the Administrator determines through a risk evaluation under this subsection that the chemical substance presents or will present, in the absence of such requirements, an unreasonable risk of injury to health or the environment. (3) Conducting risk evaluation (A) Required risk evaluations The Administrator shall conduct and publish the results of a risk evaluation under this subsection for a chemical substance if— (i) the Administrator determines that the chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use; or (ii) a manufacturer of the chemical substance requests such a risk evaluation. (B) TSCA Work Plan chemicals The Administrator may, without making a determination under subparagraph (A)(i), conduct and publish the results of a risk evaluation under this subsection for a chemical substance that, on the date of enactment of the TSCA Modernization Act of 2015 , is listed in the TSCA Work Plan for Chemical Assessments published by the Administrator. (4) Requirements In conducting a risk evaluation under this subsection, the Administrator shall— (A) integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed subpopulations; (B) not include information on cost and other factors not directly related to health or the environment; (C) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance; (D) describe the weight of the scientific evidence for identified hazard and exposure; (E) consider whether the weight of the scientific evidence supports the identification of doses of the chemical substance below which no adverse effects can be expected to occur; and (F) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), ensure that the costs to the Environmental Protection Agency, including contractor costs, of conducting the risk evaluation are paid for by the manufacturer. (5) Deadlines (A) Risk evaluations The Administrator shall conduct and publish a risk evaluation under this subsection for a chemical substance as soon as reasonably possible, subject to the availability of resources, but not later than 3 years after the date on which— (i) the Administrator— (I) makes a determination under paragraph (3)(A)(i); or (II) begins the risk evaluation under paragraph (3)(B); or (ii) a manufacturer requests the risk evaluation under paragraph (3)(A)(ii). (B) Subsection (a) rules If, based on a risk evaluation conducted under this subsection, the Administrator determines that a chemical substance presents or will present, in the absence of a rule under subsection (a), an unreasonable risk of injury to health or the environment, the Administrator shall— (i) propose a rule under subsection (a) for the chemical substance not later than 90 days after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A); and (ii) publish in the Federal Register a final rule not later than 180 days after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A). (C) Extension If the Administrator determines that additional information is necessary to make a risk evaluation determination under this subsection, the Administrator may extend the deadline under subparagraph (A) accordingly, except that the deadline may not be extended to a date that is later than— (i) 90 days after receipt of such additional information; or (ii) 2 years after the original deadline. (6) Determinations of no unreasonable risk (A) Notice and comment Not later than 30 days before publishing a final determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment, the Administrator shall make a preliminary determination to such effect and provide public notice of, and an opportunity for comment regarding, such preliminary determination. (B) Potentially exposed subpopulations The Administrator shall not make a determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment if the Administrator determines that the chemical substance, under the intended conditions of use, poses an unreasonable risk of injury to 1 or more potentially exposed subpopulations. (C) Final action A final determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment shall be considered a final agency action. (7) Minimum number Subject to the availability of appropriations, the Administrator shall initiate 10 or more risk evaluations under paragraphs (3)(A)(i) or (3)(B) in each fiscal year beginning in the fiscal year of the date of enactment of the TSCA Modernization Act of 2015 . . (c) Promulgation of subsection (a) rules Section 6(c) of the Toxic Substances Control Act ( 15 U.S.C. 2605(c) ) is amended— (1) by amending paragraph (1) to read as follows: (1) Requirements for rule In promulgating any rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall— (A) consider and publish a statement with respect to— (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture; (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to the chemical substance or mixture; (iii) the benefits of the chemical substance or mixture for various uses; and (iv) the reasonably ascertainable economic consequences of the rule, including consideration of the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; (B) impose requirements under the rule that the Administrator determines, consistent with the information published under subparagraph (A), are cost-effective, except where the Administrator determines that additional or different requirements described in subsection (a) are necessary to protect against the identified risk; (C) based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific use of a chemical substance or mixture and in setting an appropriate transition period for such action, determine whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or restriction takes effect; (D) exempt replacement parts designed prior to the date of publication in the Federal Register of the rule unless the Administrator finds such replacement parts contribute significantly to the identified risk, including identified risk to identified potentially exposed subpopulations; and (E) in selecting among prohibitions and restrictions to address an identified risk, apply prohibitions or restrictions to articles on the basis of a chemical substance or mixture contained in the article only to the extent necessary to mitigate the identified risk. ; (2) in paragraph (2)— (A) by inserting Procedures. — before When prescribing a rule ; (B) by striking provide an opportunity for an informal hearing in accordance with paragraph (3); (D) ; (C) by striking , and (E) and inserting ; and (D) ; and (D) by moving such paragraph 2 ems to the right; (3) by striking paragraphs (3) and (4) and redesignating paragraph (5) as paragraph (3); and (4) in paragraph (3) (as so redesignated)— (A) by striking Paragraphs (1), (2), (3), and (4) and inserting Application.— Paragraphs (1) and (2) ; and (B) by moving such paragraph 2 ems to the right. (d) Effective date Section 6(d)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2605(d)(2)(B) ) is amended by adding at the end the following: Any rule promulgated under subsection (a) shall provide for a reasonable transition period. . (e) Non-Risk factors; critical use exemptions; PBT chemicals Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended by adding at the end the following: (g) Non-Risk factors The Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a). (h) Critical use exemptions (1) Criteria for exemption The Administrator may grant an exemption from a requirement of a subsection (a) rule for a specific use of a chemical substance or mixture, if— (A) the requirement is not cost-effective with respect to the specific use, as determined by the Administrator pursuant to subsection (c)(1)(B); and (B) the Administrator finds that— (i) the specific use is a critical or essential use; or (ii) the requirement, as applied with respect to the specific use, would significantly disrupt the national economy, national security, or critical infrastructure. (2) Procedure An exemption granted under paragraph (1) shall be— (A) supported by clear and convincing evidence; (B) preceded by public notice of the proposed exemption and an opportunity for comment; and (C) followed by notice of the granted exemption— (i) to the public, by the Administrator; and (ii) to known commercial purchasers of the chemical substance or mixture with respect to which the exemption applies, by the manufacturers and processors of such chemical substance or mixture. (3) Period of exemption An exemption granted under paragraph (1) shall expire after a period not to exceed 5 years, but may be renewed for one or more additional 5-year periods if the Administrator finds that the requirements of paragraph (1) continue to be met. (4) Conditions The Administrator shall impose conditions on any use for which an exemption is granted under paragraph (1) to reduce risk from the chemical substance or mixture to the greatest extent feasible. (i) Chemicals that are persistent, bioaccumulative, and toxic (1) Identification Not later than 9 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall publish a list of those chemical substances that the Administrator has a reasonable basis to conclude are persistent, bioaccumulative, and toxic, not including any chemical substance that is a metal, a metal compound, or subject to subsection (e). (2) Confirmation of concern Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall designate as a PBT chemical of concern each chemical substance on the list published under paragraph (1)— (A) that, with respect to persistence and bioaccumulation, scores high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012; and (B) exposure to which is likely to the general population or to a potentially exposed subpopulation identified by the Administrator. (3) Expedited action Notwithstanding subsection (b)(2), subject to the availability of appropriations, not later than 2 years after designating a chemical substance under paragraph (2), the Administrator shall promulgate a rule under subsection (a) with respect to the chemical substance to reduce likely exposure to the extent practicable. (4) Relationship to subsection (b) If, at any time prior to the date that is 90 days after the date on which the Administrator publishes the list under paragraph (1), the Administrator makes a finding under subsection (b)(3)(A)(i), or a manufacturer requests a risk evaluation under subsection (b)(3)(A)(ii), with respect to a chemical substance, such chemical substance shall not be subject to this subsection. . 5. Relationship to other Federal laws Section 9(b) of the Toxic Substances Control Act ( 15 U.S.C. 2608(b) ) is amended— (1) by striking The Administrator shall coordinate and inserting (1) The Administrator shall coordinate ; and (2) by adding at the end the following: (2) In making a determination under paragraph (1) that it is in the public interest for the Administrator to take an action under this title with respect to a chemical substance or mixture rather than under another law administered in whole or in part by the Administrator, the Administrator shall compare the relevant risks, estimated costs, and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk. . 6. Disclosure of data Section 14 of the Toxic Substances Control Act ( 15 U.S.C. 2613 ) is amended— (1) in subsection (a)— (A) by striking or at the end of paragraph (3); (B) by striking the period at the end of paragraph (4) and inserting a semicolon; and (C) by adding after paragraph (4) the following new paragraphs: (5) may be disclosed to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law; and (6) shall be disclosed upon request— (A) to a health or environmental professional employed by a Federal or State agency in response to an environmental release; or (B) to a treating physician or other health care professional to assist in the diagnosis or treatment of 1 or more individuals. ; (2) in subsection (b)(1), in the matter following subparagraph (B)— (A) by striking data which discloses and inserting data that disclose formulas (including molecular structures) of a chemical substance or mixture, ; (B) by striking mixture or, and inserting mixture, or, ; and (C) by striking the release of data disclosing ; (3) in subsection (c)— (A) by striking the subsection heading and inserting Designating and substantiating confidentiality.— ; and (B) by amending paragraph (1) to read as follows: (1) (A) In submitting information under this Act after the date of enactment of the TSCA Modernization Act of 2015 , a manufacturer, processor, or distributor in commerce shall designate the information which such person believes is entitled to protection under this section, and submit such designated information separately from other information submitted under this Act. A designation under this subparagraph shall be made in writing and in such manner as the Administrator may prescribe, and shall include— (i) justification for each designation of confidentiality; (ii) a certification that the information is not otherwise publicly available; and (iii) separate copies of all submitted information, with 1 copy containing and 1 copy excluding the information to which the request applies. (B) Designations made under subparagraph (A) after the date of enactment of the TSCA Modernization Act of 2015 shall expire after 10 years, at which time the information shall be made public unless the manufacturer, processor, or distributor in commerce has submitted a request for renewal, made in writing and in such manner as the Administrator may prescribe, including all of the elements required for the initial submission. (C) Not later than 60 days prior to making information public under subparagraph (B), the Administrator shall notify, as appropriate and practicable, the manufacturer, processor, or distributor in commerce who designated the information under subparagraph (A) of the date on which such information will be made public unless a request for renewal is granted under subparagraph (B). ; and (4) by adding at the end the following new subsections: (f) Prohibition No person who receives information as permitted under subsection (a) may use such information for any purpose not specified in such subsection, nor disclose such information to any person not authorized to receive such information. (g) Savings Nothing in this section shall be construed to affect the applicability of State or Federal rules of evidence or procedure in any judicial proceeding. . 7. Effect on State law (a) In general Section 18(a) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a) ) is amended— (1) in paragraph (2)(A), by striking ; and and inserting a semicolon; (2) by striking paragraph (2)(B) and inserting the following: (B) if the Administrator makes a final determination under section 6(b) that a chemical substance will not present an unreasonable risk of injury to health or the environment under the intended condition of use, no State or political subdivision may, after the date of publication of such determination, establish or continue in effect any requirement that applies to such chemical substance under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b), and is designed to protect against exposure to such chemical substance under the intended conditions of use, unless the requirement of the State or political subdivision— (i) is adopted under the authority of a Federal law; or (ii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement; and (C) if the Administrator imposes a requirement, through a rule or order under section 5 or 6, that applies to a chemical substance or mixture (other than a requirement described in section 6(a)(6)) and is designed to protect against a risk of injury to health or the environment associated with such chemical substance or mixture, no State or political subdivision may, after the effective date of such requirement, establish or continue in effect any requirement that applies to such chemical substance or mixture (including a requirement that applies to an article because the article contains the chemical substance or mixture) and is designed to protect against exposure to the chemical substance or mixture either under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b) or from a use identified in a notice received by the Administrator under section 5(a), or, in the case of a requirement imposed pursuant to section 6(i), is designed to protect against a risk of injury considered by the Administrator in imposing such requirement, unless the requirement of the State or political subdivision— (i) is identical to the requirement imposed by the Administrator; (ii) is adopted under the authority of a Federal law; or (iii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement. ; and (3) by adding at the end the following: (3) In the case of an identical requirement described in paragraph (2)(C)(i)— (A) a State may not assess a penalty for a specific violation for which the Administrator has assessed a penalty under section 16; and (B) if a State has assessed a penalty for a specific violation, the Administrator 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 Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16. . (b) Savings Section 18 of the Toxic Substances Control Act ( 15 U.S.C. 2617 ) is amended by adding at the end the following: (c) Savings (1) Prior State actions Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken before August 1, 2015, under the authority of a State law that prohibits or otherwise restricts the manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance, or any action taken pursuant to a State law that was in effect on August 31, 2003, unless an action or determination made by the Administrator under this title actually conflicts with the action taken pursuant to such a State law. (2) Tort and contract law Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect either Federal or State tort law or the law governing the interpretation of contracts of any State, including any remedy for civil relief, whether under statutory or common law, including a remedy for civil damages, and any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory relating to tort law. (3) Intent of Congress It is not the intent of Congress that this title, or rules, regulations, or orders issued pursuant to this title, be interpreted as influencing, in either a plaintiff’s or defendant’s favor, the disposition of any civil action for damages in a State court, or the authority of any court to make a determination in an adjudicatory proceeding under applicable State law with respect to the admissibility of evidence, unless a provision of this title actually conflicts with the State court action. (4) Application For purposes of this title, the term requirements does not include civil tort actions for damages under State law. . (c) Effect of actions by Administrator Nothing in this Act, or the amendments made by this Act, shall be construed as changing the preemptive effect of an action taken by the Administrator prior to the date of enactment of this Act or under section 6(e). 8. Administration of the Act Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) in subsection (b)(1)— (A) by striking of a reasonable fee ; (B) by inserting of a fee that is sufficient and not more than reasonably necessary after section 4 or 5 ; (C) by inserting , or who requests a risk evaluation under section 6(b)(3)(A)(ii), before to defray the cost ; (D) by striking this Act and inserting the provision of this title for which such fee is collected ; and (E) by striking Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. and inserting Such rules shall provide for lower fees for small business concerns. ; (2) by adding at the end of subsection (b) the following: (3) Fund (A) Establishment There is established in the Treasury of the United States a revolving fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the Fund ), consisting of such amounts as are deposited in the Fund under this paragraph. (B) Collection and deposit of fees The Administrator shall collect the fees described in paragraph (1) and deposit those fees in the Fund. (C) Crediting and availability of fees On request by the Administrator, the Secretary of the Treasury shall transfer from the Fund to the Administrator amounts appropriated to pay or recover the full costs incurred by the Environmental Protection Agency, including contractor costs, in carrying out the provisions of this title for which the fees are collected under paragraph (1). (D) Use of funds by Administrator Amounts equivalent to fees collected by the Administrator and deposited in the Fund under this section shall be available without fiscal year limitation to the Administrator, subject to the availability of appropriations, for use only in administering the provisions of this title for which the fees are collected. (E) Accounting and auditing (i) Accounting The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code. (ii) Auditing (I) In general For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency. (II) Components of audit The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of— (aa) the fees collected and amounts disbursed under this subsection; (bb) the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the title for which the fees are collected; and (cc) the number of requests for a risk evaluation made by manufacturers under section 6(b)(3)(A)(ii). (III) Federal responsibility The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit. ; and (3) by adding at the end the following: (h) Scientific standards In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall consider, as applicable— (1) the extent to which the scientific and technical procedures, measures, methods, or models employed to generate the information are reasonable for and consistent with the use of the information; (2) the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, or models, are evaluated and characterized; and (5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, or models. (i) Weight of scientific evidence The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence. (j) Availability of information Subject to section 14, the Administrator shall make available to the public all notices, determinations, findings, rules, and orders of the Administrator under this title. (k) Policies, procedures, and guidance (1) Development Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the TSCA Modernization Act of 2015 . (2) Review Not later than 5 years after the date of enactment of the TSCA Modernization Act of 2015 , and not less frequently than once every 5 years thereafter, the Administrator shall— (A) review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and (B) revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings. (l) Report to Congress (1) Initial report Not later than 6 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of— (A) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under subparagraphs (A)(i) and (B) of section 6(b)(3), and the resources necessary to initiate the minimum number of risk evaluations required under section 6(b)(7); (B) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(3)(A)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand; (C) the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and (D) the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b). (2) Subsequent reports The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years. . 9. Conforming amendments (a) Section 4 Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (b)— (A) in paragraph (1), by striking rule each place it appears and inserting rule, order, or consent agreement ; (B) in paragraph (2)(B), by striking rules and inserting rules, orders, and consent agreements ; (C) in paragraph (3), by striking rule each place it appears and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule under subsection (a) each place it appears and inserting rule, order, or consent agreement under subsection (a) ; (ii) by striking repeals the rule each place it appears and inserting repeals the rule or order or modifies the consent agreement to terminate the requirement ; and (iii) by striking repeals the application of the rule and inserting repeals or modifies the application of the rule, order, or consent agreement ; (2) in subsection (c)— (A) in paragraph (1), by striking rule and inserting rule or order ; (B) in paragraph (2)— (i) in subparagraph (A), by striking a rule under subsection (a) or for which data is being developed pursuant to such a rule and inserting a rule, order, or consent agreement under subsection (a) or for which data is being developed pursuant to such a rule, order, or consent agreement ; (ii) in subparagraph (B), by striking such rule or which is being developed pursuant to such rule and inserting such rule, order, or consent agreement or which is being developed pursuant to such rule, order, or consent agreement ; and (iii) in the matter following subparagraph (B), by striking the rule and inserting the rule or order ; (C) in paragraph (3)(B)(i), by striking rule promulgated and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule promulgated each place it appears and inserting rule, order, or consent agreement ; (ii) by striking such rule each place it appears and inserting such rule, order, or consent agreement ; and (iii) in subparagraph (B), by striking the rule and inserting the rule, order, or consent agreement ; (3) in subsection (d), by striking rule and inserting rule, order, or consent agreement ; and (4) in subsection (g), by striking rule and inserting rule, order, or consent agreement . (b) Section 5 Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) in subsection (b)— (A) in paragraph (1)(A)— (i) by striking rule promulgated and inserting rule, order, or consent agreement ; and (ii) by striking such rule and inserting such rule, order, or consent agreement ; (B) in paragraph (1)(B)— (i) by striking rule promulgated and inserting rule or order ; and (ii) by striking the date of the submission in accordance with such rule and inserting the required date of submission ; and (C) in paragraph (2)(A)(ii), by striking rule promulgated and inserting rule, order, or consent agreement ; (2) in subsection (d)(2)(C), by striking rule and inserting rule, order, or consent agreement ; and (3) in subsection (h)(4), by striking paragraphs (2) and (3) of section 6(c) and inserting paragraph (2) of section 6(c) . (c) Section 6 Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— (1) in subsection (d)(2)(B), by striking paragraphs (2) and (3) of subsection (c) and inserting paragraph (2) of subsection (c) ; and (2) in subsection (e)(4), by striking paragraphs (2), (3), and (4) of subsection (c) and inserting paragraph (2) of subsection (c) . (d) Section 7 Section 7(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2606(a)(1) ) is amended, in the matter following subparagraph (C), by striking a rule under section 4, 5, 6, or title IV or an order under section 5 or title IV and inserting a rule under section 4, 5, or 6 or title IV, an order under section 4 or 5 or title IV, or a consent agreement under section 4 . (e) Section 8 Section 8(a)(3)(A)(ii)(I) of the Toxic Substances Control Act ( 15 U.S.C. 2607(a)(3)(A)(ii)(I) ) is amended by striking or an order in effect under section 5(e) and inserting , an order in effect under section 4 or 5(e), or a consent agreement under section 4 . (f) Section 9 Section 9(a) of the Toxic Substances Control Act ( 15 U.S.C. 2608(a) ) is amended by striking section 6 each place it appears and inserting section 6(a) . (g) Section 11 Section 11(b)(2)(E) of the Toxic Substances Control Act ( 15 U.S.C. 2610(b)(2)(E) ) is amended by striking rule promulgated and inserting rule promulgated, order issued, or consent agreement entered into . (h) Section 15 Section 15(1) of the Toxic Substances Control Act ( 15 U.S.C. 2614(1) ) is amended by striking (A) any rule and all that follows through or (D) and inserting any requirement of this title or any rule promulgated, order issued, or consent agreement entered into under this title, or . (i) Section 18 Section 18(a)(2)(A) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a)(2)(A) ) is amended— (1) by striking rule promulgated and inserting rule, order, or consent agreement ; and (2) by striking such rule each place it appears and inserting such rule, order, or consent agreement . (j) Section 19 Section 19 of the Toxic Substances Control Act ( 15 U.S.C. 2618 ) is amended— (1) in subsection (a)— (A) in paragraph (1)(A)— (i) by striking (A) Not later than 60 days after the date of the promulgation of a rule and inserting Not later than 60 days after the date on which a rule is promulgated ; (ii) by inserting or the date on which an order is issued under section 4, before any person ; (iii) by striking such rule and inserting such rule or order ; and (iv) by striking such a rule and inserting such a rule or order ; (B) by striking paragraph (1)(B); (C) in paragraph (2), by striking the rule and inserting the rule or order ; and (D) in paragraph (3)— (i) in subparagraph (A), by striking the rule and inserting the rule or order ; (ii) in subparagraph (B), by striking a rule under section 4(a) and inserting a rule or order under section 4(a) ; (iii) in subparagraph (C), by striking such rule and inserting such rule or order ; (iv) in subparagraph (D), by striking such rule and inserting such rule or order ; and (v) in subparagraph (E)— (I) by striking to such rule and inserting to such rule or order ; and (II) by striking the date of the promulgation of such rule and inserting the date on which such rule is promulgated or such order is issued ; (2) in subsection (b)— (A) by striking review a rule and inserting review a rule, or an order under section 4, ; (B) by striking such rule and inserting such rule or order ; (C) by striking the rule and inserting the rule or order ; (D) by striking new rule each place it appears and inserting new rule or order ; and (E) by striking modified rule and inserting modified rule or order ; and (3) in subsection (c)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking a rule and inserting a rule, or an order under section 4 ; and (II) by striking such rule and inserting such rule or order ; and (ii) in subparagraph (B)— (I) in the matter preceding clause (i), by striking a rule and inserting a rule or order ; and (II) in clause (i)— (aa) by inserting or an order under section 4, before the standard for review ; (bb) by striking such rule and inserting such rule or order ; and (cc) by striking the rule and inserting the rule or order ; and (B) in paragraph (2), by striking any rule and inserting any rule or order . (k) Section 20 Section 20(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2619(a)(1) ) is amended by striking order issued under section 5 and inserting order issued under section 4 or 5 . (l) Section 21 Section 21 of the Toxic Substances Control Act ( 15 U.S.C. 2620 ) is amended— (1) in subsection (a), by striking order under section 5(e) or (6)(b)(2) and inserting order under section 4 or 5(e) ; and (2) in subsection (b)— (A) in paragraph (1), by striking order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B) and inserting order under section 4 or 5(e) ; and (B) in paragraph (4)(B)— (i) in the matter preceding clause (i), by striking order under section 5(e) or 6(b)(2) and inserting order under section 4 or 5(e) ; (ii) in clause (i), by striking order under section 5(e) and inserting order under section 4 or 5(e) ; and (iii) in clause (ii), by striking or an order under section 6(b)(2) . (m) Section 24 Section 24(b)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2623(b)(2)(B) ) is amended— (1) by inserting and at the end of clause (i); (2) by striking clause (ii); and (3) by redesignating clause (iii) as clause (ii). (n) Section 27 Section 27(a) of the Toxic Substances Control Act ( 15 U.S.C. 2626(a) ) is amended by striking rules promulgated and inserting rules, orders, or consent agreements . (o) Section 30 Section 30(2) of the Toxic Substances Control Act ( 15 U.S.C. 2629(2) ) is amended by striking rule and inserting rule, order, or consent agreement .

tv_txt: I 114th CONGRESS 1st Session H. R. 2576 IN THE HOUSE OF REPRESENTATIVES AN ACT To modernize the Toxic Substances Control Act, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the TSCA Modernization Act of 2015 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Definitions. Sec. 3. Testing of chemical substances and mixtures. Sec. 4. Regulation of hazardous chemical substances and mixtures. Sec. 5. Relationship to other Federal laws. Sec. 6. Disclosure of data. Sec. 7. Effect on State law. Sec. 8. Administration of the Act. Sec. 9. Conforming amendments. 2. Definitions Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) by redesignating paragraphs (7) through (14) as paragraphs (8) through (10) and (12) through (16), respectively; (2) by inserting after paragraph (6) the following: (7) The term intended conditions of use means the circumstances under which a chemical substance is intended, known, or reasonably foreseeable to be manufactured, processed, distributed in commerce, used, and disposed of. ; and (3) by inserting after paragraph (10), as so redesignated, the following: (11) The term potentially exposed subpopulation means a group of individuals within the general population who, due to either greater susceptibility or greater potential exposure, are likely to be at greater risk than the general population of adverse health effects from exposure to a chemical substance. . 3. Testing of chemical substances and mixtures Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (A)(iii), by striking ; or and inserting a semicolon; (B) in subparagraph (B)(iii), by striking ; and and inserting ; or ; and (C) by adding at the end the following: (C) testing of a chemical substance is necessary to conduct a risk evaluation under section 6(b); and ; (2) in the matter following subsection (a)(2), by inserting , order, or consent agreement after by rule ; and (3) in subsection (b)(5), by striking paragraph (1)(A) or (1)(B) and inserting paragraph (1)(A), (1)(B), or (1)(C) . 4. Regulation of hazardous chemical substances and mixtures (a) Scope of regulation Section 6(a) of the Toxic Substances Control Act ( 15 U.S.C. 2605(a) ) is amended— (1) by striking finds that there is a reasonable basis to conclude and inserting determines under subsection (b) ; (2) by inserting or designates a chemical substance under subsection (i)(2), before the Administrator shall by rule ; and (3) by striking to protect adequately against such risk using the least burdensome requirements and inserting so that the chemical substance or mixture no longer presents or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulation . (b) Risk evaluations Section 6(b) of the Toxic Substances Control Act ( 15 U.S.C. 2605(b) ) is amended to read as follows: (b) Risk evaluations (1) In general The Administrator shall conduct risk evaluations pursuant to this subsection to determine whether or not a chemical substance presents or will present, in the absence of requirements under subsection (a), an unreasonable risk of injury to health or the environment. (2) Applying requirements The Administrator shall apply requirements with respect to a chemical substance through a rule under subsection (a) only if the Administrator determines through a risk evaluation under this subsection, without consideration of costs or other non-risk factors, that the chemical substance presents or will present, in the absence of such requirements, an unreasonable risk of injury to health or the environment. (3) Conducting risk evaluation (A) Required risk evaluations The Administrator shall conduct and publish the results of a risk evaluation under this subsection for a chemical substance if— (i) the Administrator determines that the chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use; or (ii) a manufacturer of the chemical substance requests such a risk evaluation in a form and manner prescribed by the Administrator. (B) TSCA Work Plan chemicals The Administrator may, without making a determination under subparagraph (A)(i), conduct and publish the results of a risk evaluation under this subsection for a chemical substance that, on the date of enactment of the TSCA Modernization Act of 2015 , is listed in the TSCA Work Plan for Chemical Assessments published by the Administrator. (4) Requirements In conducting a risk evaluation under this subsection, the Administrator shall— (A) integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed subpopulations; (B) not consider information on cost and other factors not directly related to health or the environment; (C) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance; (D) describe the weight of the scientific evidence for identified hazard and exposure; (E) consider whether the weight of the scientific evidence supports the identification of doses of the chemical substance below which no adverse effects can be expected to occur; and (F) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), ensure that the costs to the Environmental Protection Agency, including contractor costs, of conducting the risk evaluation are paid for by the manufacturer. (5) Deadlines (A) Risk evaluations The Administrator shall conduct and publish a risk evaluation under this subsection for a chemical substance as soon as reasonably possible, subject to the availability of resources, but not later than— (i) 3 years after the date on which the Administrator— (I) makes a determination under paragraph (3)(A)(i); or (II) begins the risk evaluation under paragraph (3)(B); or (ii) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), 2 years after the later of the date on which— (I) the manufacturer requests the risk evaluation; or (II) if applicable, the risk evaluation is initiated pursuant to subparagraph (B). (B) Deadline adjustment If the Administrator receives more requests for risk evaluations under paragraph (3)(A)(ii) than the Administrator has resources to conduct by the deadline under subparagraph (A)(ii)(I) (taking into account the requirement in paragraph (4)(F)), the Administrator shall— (i) initiate risk evaluations that exceed the Administrator’s allotted resources as soon as resources for such risk evaluations are available; and (ii) not collect a fee under section 26 from the manufacturer for a risk evaluation until the Administrator initiates the risk evaluation. (C) Subsection (a) rules If, based on a risk evaluation conducted under this subsection, the Administrator determines, without consideration of costs or other non-risk factors, that a chemical substance presents or will present, in the absence of a rule under subsection (a), an unreasonable risk of injury to health or the environment, the Administrator shall— (i) propose a rule under subsection (a) for the chemical substance not later than 1 year after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A); and (ii) publish in the Federal Register a final rule not later than 2 years after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A). (D) Extension If the Administrator determines that additional information is necessary to make a risk evaluation determination under this subsection, the Administrator may extend the deadline under subparagraph (A) accordingly, except that the deadline may not be extended to a date that is later than— (i) 90 days after receipt of such additional information; or (ii) 2 years after the deadline being extended under this subparagraph. (6) Determinations of no unreasonable risk (A) Notice and comment Not later than 30 days before publishing a final determination under this subsection that a chemical substance does not and will not present an unreasonable risk of injury to health or the environment, the Administrator shall make a preliminary determination to such effect and provide public notice of, and an opportunity for comment regarding, such preliminary determination. (B) Potentially exposed subpopulations The Administrator shall not make a determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment if the Administrator determines that the chemical substance, under the intended conditions of use, presents or will present an unreasonable risk of injury to one or more potentially exposed subpopulations. (C) Final action A final determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment shall be considered a final agency action. (7) Minimum number Subject to the availability of appropriations, the Administrator shall initiate 10 or more risk evaluations under paragraphs (3)(A)(i) or (3)(B) in each fiscal year beginning in the fiscal year of the date of enactment of the TSCA Modernization Act of 2015 . . (c) Promulgation of subsection (a) rules Section 6(c) of the Toxic Substances Control Act ( 15 U.S.C. 2605(c) ) is amended— (1) by amending paragraph (1) to read as follows: (1) Requirements for rule In promulgating any rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall— (A) consider and publish a statement with respect to— (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture; (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to the chemical substance or mixture; (iii) the benefits of the chemical substance or mixture for various uses; and (iv) the reasonably ascertainable economic consequences of the rule, including consideration of the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; (B) impose requirements under the rule that the Administrator determines, consistent with the information published under subparagraph (A), are cost-effective, except where the Administrator determines that additional or different requirements described in subsection (a) are necessary to protect against the identified risk; (C) based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific use of a chemical substance or mixture and in setting an appropriate transition period for such action, determine whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect; (D) exempt replacement parts designed prior to the date of publication in the Federal Register of the rule unless the Administrator finds such replacement parts contribute significantly to the identified risk, including identified risk to identified potentially exposed subpopulations; and (E) in selecting among prohibitions and other restrictions to address an identified risk, apply prohibitions or other restrictions to articles on the basis of a chemical substance or mixture contained in the article only to the extent necessary to protect against the identified risk. ; (2) in paragraph (2)— (A) by inserting Procedures. — before When prescribing a rule ; (B) by striking provide an opportunity for an informal hearing in accordance with paragraph (3); (D) ; (C) by striking , and (E) and inserting ; and (D) ; and (D) by moving such paragraph 2 ems to the right; (3) by striking paragraphs (3) and (4) and redesignating paragraph (5) as paragraph (3); and (4) in paragraph (3) (as so redesignated)— (A) by striking Paragraphs (1), (2), (3), and (4) and inserting Application.— Paragraphs (1) and (2) ; and (B) by moving such paragraph 2 ems to the right. (d) Effective date Section 6(d)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2605(d)(2)(B) ) is amended by adding at the end the following: Any rule promulgated under subsection (a) shall provide for a reasonable transition period. . (e) Non-Risk factors; critical use exemptions; PBT chemicals Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended by adding at the end the following: (g) Non-Risk factors The Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a). (h) Critical use exemptions (1) Criteria for exemption The Administrator may grant an exemption from a requirement of a subsection (a) rule for a specific use of a chemical substance or mixture, if— (A) the requirement is not cost-effective with respect to the specific use, as determined by the Administrator pursuant to subsection (c)(1)(B); and (B) the Administrator finds that— (i) the specific use is a critical or essential use; or (ii) the requirement, as applied with respect to the specific use, would significantly disrupt the national economy, national security, or critical infrastructure. (2) Procedure An exemption granted under paragraph (1) shall be— (A) supported by clear and convincing evidence; (B) preceded by public notice of the proposed exemption and an opportunity for comment; and (C) followed by notice of the granted exemption— (i) to the public, by the Administrator; and (ii) to known commercial purchasers of the chemical substance or mixture with respect to which the exemption applies, by the manufacturers and processors of such chemical substance or mixture. (3) Period of exemption An exemption granted under paragraph (1) shall expire after a period not to exceed 5 years, but may be renewed for one or more additional 5-year periods if the Administrator finds that the requirements of paragraph (1) continue to be met. (4) Conditions The Administrator shall impose conditions on any use for which an exemption is granted under paragraph (1) to reduce risk from the chemical substance or mixture to the greatest extent feasible. (i) Chemicals that are persistent, bioaccumulative, and toxic (1) Identification Not later than 9 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall publish a list of those chemical substances that the Administrator has a reasonable basis to conclude are persistent, bioaccumulative, and toxic, not including any chemical substance that is a metal, a metal compound, or subject to subsection (e). (2) Confirmation of concern Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall designate as a PBT chemical of concern each chemical substance on the list published under paragraph (1)— (A) that, with respect to persistence and bioaccumulation, scores high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012; and (B) exposure to which is likely to the general population or to a potentially exposed subpopulation identified by the Administrator. (3) Expedited action Notwithstanding subsection (b)(2), subject to the availability of appropriations, not later than 2 years after designating a chemical substance under paragraph (2), the Administrator shall promulgate a rule under subsection (a) with respect to the chemical substance to reduce likely exposure to the extent practicable. (4) Relationship to subsection (b) If, at any time prior to the date that is 90 days after the date on which the Administrator publishes the list under paragraph (1), the Administrator makes a finding under subsection (b)(3)(A)(i), or a manufacturer requests a risk evaluation under subsection (b)(3)(A)(ii), with respect to a chemical substance, such chemical substance shall not be subject to this subsection. . 5. Relationship to other Federal laws Section 9(b) of the Toxic Substances Control Act ( 15 U.S.C. 2608(b) ) is amended— (1) by striking The Administrator shall coordinate and inserting (1) The Administrator shall coordinate ; and (2) by adding at the end the following: (2) In making a determination under paragraph (1) that it is in the public interest for the Administrator to take an action under this title with respect to a chemical substance or mixture rather than under another law administered in whole or in part by the Administrator, the Administrator shall consider the relevant risks, and compare the estimated costs and efficiencies, of the action to be taken under this title and an action to be taken under such other law to protect against such risk. . 6. Disclosure of data Section 14 of the Toxic Substances Control Act ( 15 U.S.C. 2613 ) is amended— (1) in subsection (a)— (A) by striking or at the end of paragraph (3); (B) by striking the period at the end of paragraph (4) and inserting a semicolon; and (C) by adding after paragraph (4) the following new paragraphs: (5) may be disclosed to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law; and (6) shall be disclosed upon request— (A) to a health or environmental professional employed by a Federal or State agency in response to an environmental release; or (B) to a treating physician or other health care professional to assist in the diagnosis or treatment of one or more individuals. ; (2) in subsection (b)(1), in the matter following subparagraph (B)— (A) by striking data which discloses and inserting data that disclose formulas (including molecular structures) of a chemical substance or mixture, ; (B) by striking mixture or, and inserting mixture, or, ; and (C) by striking the release of data disclosing ; (3) in subsection (c)— (A) by striking the subsection heading and inserting Designating and substantiating confidentiality.— ; (B) by amending paragraph (1) to read as follows: (1) (A) In submitting information under this Act after date of enactment of the TSCA Modernization Act of 2015 , a manufacturer, processor, or distributor in commerce shall designate the information which such person believes is entitled to protection under this section, and submit such designated information separately from other information submitted under this Act. A designation under this subparagraph shall be made in writing and in such manner as the Administrator may prescribe, and shall include— (i) justification for each designation of confidentiality; (ii) a certification that the information is not otherwise publicly available; and (iii) separate copies of all submitted information, with one copy containing and one copy excluding the information to which the request applies. (B) Designations made under subparagraph (A) after the date of enactment of the TSCA Modernization Act of 2015 shall expire after 10 years, at which time the information shall be made public unless the manufacturer, processor, or distributor in commerce has reasserted the claim for protection, in writing and in such manner as the Administrator may prescribe, including all of the elements required for the initial submission. (C) Not later than 60 days prior to making information public under subparagraph (B), the Administrator shall notify, as appropriate and practicable, the manufacturer, processor, or distributor in commerce who designated the information under subparagraph (A) of the date on which such information will be made public unless a request for renewal is granted under subparagraph (B). ; and (C) in paragraph (2)— (i) in subparagraph (A), by inserting , for a reason other than the expiration of such designation pursuant to paragraph (1)(B), before proposes to release ; and (ii) in subparagraph (B)(i), by striking or (4) and inserting (4), or (6) ; and (4) by adding at the end the following new subsections: (f) Prohibition No person who receives information as permitted under subsection (a) may use such information for any purpose not specified in such subsection, nor disclose such information to any person not authorized to receive such information. (g) Savings Nothing in this section shall be construed to affect the applicability of State or Federal rules of evidence or procedure in any judicial proceeding. . 7. Effect on State law (a) In general Section 18(a) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a) ) is amended— (1) in paragraph (2)(A), by striking ; and and inserting a semicolon; (2) by striking paragraph (2)(B) and inserting the following: (B) if the Administrator makes a final determination under section 6(b) that a chemical substance will not present an unreasonable risk of injury to health or the environment under the intended condition of use, no State or political subdivision may, after the date of publication of such determination, establish or continue in effect any requirement that applies to such chemical substance under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b), and is designed to protect against exposure to such chemical substance under the intended conditions of use, unless the requirement of the State or political subdivision— (i) is adopted under the authority of a Federal law; or (ii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement; and (C) if the Administrator imposes a requirement, through a rule or order under section 5 or 6, that applies to a chemical substance or mixture (other than a requirement described in section 6(a)(6)) and is designed to protect against a risk of injury to health or the environment associated with such chemical substance or mixture, no State or political subdivision may, after the effective date of such requirement, establish or continue in effect any requirement that applies to such chemical substance or mixture (including a requirement that applies to an article because the article contains the chemical substance or mixture) and is designed to protect against exposure to the chemical substance or mixture either under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b) or from a use identified in a notice received by the Administrator under section 5(a), or, in the case of a requirement imposed pursuant to section 6(i), is designed to protect against a risk of injury considered by the Administrator in imposing such requirement, unless the requirement of the State or political subdivision— (i) is identical to the requirement imposed by the Administrator; (ii) is adopted under the authority of a Federal law; or (iii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement. ; and (3) by adding at the end the following: (3) In the case of an identical requirement described in paragraph (2)(C)(i)— (A) a State may not assess a penalty for a specific violation for which the Administrator has assessed a penalty under section 16; and (B) if a State has assessed a penalty for a specific violation, the Administrator 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 Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16. . (b) Savings Section 18 of the Toxic Substances Control Act ( 15 U.S.C. 2617 ) is amended by adding at the end the following: (c) Savings (1) Prior State actions Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken or requirement that has taken effect— (A) before August 1, 2015, under the authority of a State law that prohibits or otherwise restricts the manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or (B) pursuant to a State law that was in effect on August 31, 2003, unless an action or determination made by the Administrator under this title actually conflicts with the action taken or requirement that has taken effect pursuant to such a State law. (2) Tort and contract law Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect either Federal or State tort law or the law governing the interpretation of contracts of any State, including any remedy for civil relief, whether under statutory or common law, including a remedy for civil damages, and any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory relating to tort law. (3) Intent of Congress It is not the intent of Congress that this title, or rules, regulations, or orders issued pursuant to this title, be interpreted as influencing, in either a plaintiff’s or defendant’s favor, the disposition of any civil action for damages in a State court, or the authority of any court to make a determination in an adjudicatory proceeding under applicable State law with respect to the admissibility of evidence, unless a provision of this title actually conflicts with the State court action. (4) Application For purposes of this title, the term requirements does not include civil tort actions for damages under State law. . (c) Effect of actions by Administrator Nothing in this Act, or the amendments made by this Act, shall be construed as changing the preemptive effect of an action taken by the Administrator prior to the date of enactment of this Act or under section 6(e). 8. Administration of the Act Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) in subsection (b)(1)— (A) by striking of a reasonable fee ; (B) by inserting of a fee that is sufficient and not more than reasonably necessary after section 4 or 5 ; (C) by inserting , or who requests a risk evaluation under section 6(b)(3)(A)(ii), before to defray the cost ; (D) by striking this Act and inserting the provision of this title for which such fee is collected ; and (E) by striking Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. and inserting Such rules shall provide for lower fees for small business concerns. ; (2) by adding at the end of subsection (b) the following: (3) Fund (A) Establishment There is established in the Treasury of the United States a revolving fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the Fund ), consisting of such amounts as are deposited in the Fund under this paragraph. (B) Collection and deposit of fees The Administrator shall collect the fees described in paragraph (1) and deposit those fees in the Fund. (C) Crediting and availability of fees On request by the Administrator, the Secretary of the Treasury shall transfer from the Fund to the Administrator amounts appropriated to pay or recover the full costs incurred by the Environmental Protection Agency, including contractor costs, in carrying out the provisions of this title for which the fees are collected under paragraph (1). (D) Use of funds by Administrator Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation for use only in administering the provisions of this title for which the fees are collected. (E) Accounting and auditing (i) Accounting The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code. (ii) Auditing (I) In general For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency. (II) Components of audit The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of— (aa) the fees collected and amounts disbursed under this subsection; (bb) the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the title for which the fees are collected; and (cc) the number of requests for a risk evaluation made by manufacturers under section 6(b)(3)(A)(ii). (III) Federal responsibility The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit. ; and (3) by adding at the end the following: (h) Scientific standards In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall consider, as applicable— (1) the extent to which the scientific and technical procedures, measures, methods, or models employed to generate the information are reasonable for and consistent with the use of the information; (2) the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, or models, are evaluated and characterized; and (5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, or models. (i) Weight of scientific evidence The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence. (j) Availability of information Subject to section 14, the Administrator shall make available to the public all notices, determinations, findings, rules, and orders of the Administrator under this title. (k) Policies, procedures, and guidance (1) Development Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the TSCA Modernization Act of 2015 . (2) Review Not later than 5 years after the date of enactment of the TSCA Modernization Act of 2015 , and not less frequently than once every 5 years thereafter, the Administrator shall— (A) review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and (B) revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings. (l) Report to Congress (1) Initial report Not later than 6 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of— (A) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under subparagraphs (A)(i) and (B) of section 6(b)(3), and the resources necessary to initiate the minimum number of risk evaluations required under section 6(b)(7); (B) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(3)(A)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand; (C) the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and (D) the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b). (2) Subsequent reports The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years. . 9. Conforming amendments (a) Section 4 Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (b)— (A) in paragraph (1), by striking rule each place it appears and inserting rule, order, or consent agreement ; (B) in paragraph (2)(B), by striking rules and inserting rules, orders, and consent agreements ; (C) in paragraph (3), by striking rule each place it appears and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule under subsection (a) each place it appears and inserting rule, order, or consent agreement under subsection (a) ; (ii) by striking repeals the rule each place it appears and inserting repeals the rule or order or modifies the consent agreement to terminate the requirement ; and (iii) by striking repeals the application of the rule and inserting repeals or modifies the application of the rule, order, or consent agreement ; (2) in subsection (c)— (A) in paragraph (1), by striking rule and inserting rule or order ; (B) in paragraph (2)— (i) in subparagraph (A), by striking a rule under subsection (a) or for which data is being developed pursuant to such a rule and inserting a rule, order, or consent agreement under subsection (a) or for which data are being developed pursuant to such a rule, order, or consent agreement ; (ii) in subparagraph (B), by striking such rule or which is being developed pursuant to such rule and inserting such rule, order, or consent agreement or which is being developed pursuant to such rule, order, or consent agreement ; and (iii) in the matter following subparagraph (B), by striking the rule and inserting the rule or order ; (C) in paragraph (3)(B)(i), by striking rule promulgated and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule promulgated each place it appears and inserting rule, order, or consent agreement ; (ii) by striking such rule each place it appears and inserting such rule, order, or consent agreement ; and (iii) in subparagraph (B), by striking the rule and inserting the rule, order, or consent agreement ; (3) in subsection (d), by striking rule and inserting rule, order, or consent agreement ; and (4) in subsection (g), by striking rule and inserting rule, order, or consent agreement . (b) Section 5 Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) in subsection (b)— (A) in paragraph (1)(A)— (i) by striking rule promulgated and inserting rule, order, or consent agreement ; and (ii) by striking such rule and inserting such rule, order, or consent agreement ; (B) in paragraph (1)(B)— (i) by striking rule promulgated and inserting rule or order ; and (ii) by striking the date of the submission in accordance with such rule and inserting the required date of submission ; and (C) in paragraph (2)(A)(ii), by striking rule promulgated and inserting rule, order, or consent agreement ; (2) in subsection (d)(2)(C), by striking rule and inserting rule, order, or consent agreement ; and (3) in subsection (h)(4), by striking paragraphs (2) and (3) of section 6(c) and inserting paragraph (2) of section 6(c) . (c) Section 6 Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— (1) in subsection (d)(2)(B)— (A) by striking , provide reasonable opportunity, in accordance with paragraphs (2) and (3) of subsection (c), for a hearing on such rule, and inserting in accordance with paragraph (2) of subsection (c), ; and (B) by striking ; and if such a hearing is requested and all that follows through or revoke it. and inserting a period; and (2) in subsection (e)(4), by striking paragraphs (2), (3), and (4) of subsection (c) and inserting paragraph (2) of subsection (c) . (d) Section 7 Section 7(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2606(a)(1) ) is amended, in the matter following subparagraph (C), by striking a rule under section 4, 5, 6, or title IV or an order under section 5 or title IV and inserting a rule under section 4, 5, or 6 or title IV, an order under section 4 or 5 or title IV, or a consent agreement under section 4 . (e) Section 8 Section 8(a)(3)(A)(ii)(I) of the Toxic Substances Control Act ( 15 U.S.C. 2607(a)(3)(A)(ii)(I) ) is amended by striking or an order in effect under section 5(e) and inserting , an order in effect under section 4 or 5(e), or a consent agreement under section 4 . (f) Section 9 Section 9(a) of the Toxic Substances Control Act ( 15 U.S.C. 2608(a) ) is amended by striking section 6 each place it appears and inserting section 6(a) . (g) Section 11 Section 11(b)(2)(E) of the Toxic Substances Control Act ( 15 U.S.C. 2610(b)(2)(E) ) is amended by striking rule promulgated and inserting rule promulgated, order issued, or consent agreement entered into . (h) Section 15 Section 15(1) of the Toxic Substances Control Act ( 15 U.S.C. 2614(1) ) is amended by striking (A) any rule and all that follows through or (D) and inserting any requirement of this title or any rule promulgated, order issued, or consent agreement entered into under this title, or . (i) Section 18 Section 18(a)(2)(A) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a)(2)(A) ) is amended— (1) by striking rule promulgated and inserting rule, order, or consent agreement ; and (2) by striking such rule each place it appears and inserting such rule, order, or consent agreement . (j) Section 19 Section 19 of the Toxic Substances Control Act ( 15 U.S.C. 2618 ) is amended— (1) in subsection (a)— (A) in paragraph (1)(A)— (i) by striking (A) Not later than 60 days after the date of the promulgation of a rule and inserting Not later than 60 days after the date on which a rule is promulgated ; (ii) by inserting or the date on which an order is issued under section 4, before any person ; (iii) by striking such rule and inserting such rule or order ; and (iv) by striking such a rule and inserting such a rule or order ; (B) by striking paragraph (1)(B); (C) in paragraph (2), by striking the rule and inserting the rule or order ; and (D) in paragraph (3)— (i) in subparagraph (A), by striking the rule and inserting the rule or order ; (ii) in subparagraph (B), by striking a rule under section 4(a) and inserting a rule or order under section 4(a) ; (iii) in subparagraph (C), by striking such rule and inserting such rule or order ; (iv) in subparagraph (D), by striking such rule and inserting such rule or order ; and (v) in subparagraph (E)— (I) by striking to such rule and inserting to such rule or order ; and (II) by striking the date of the promulgation of such rule and inserting the date on which such rule is promulgated or such order is issued ; (2) in subsection (b)— (A) by striking review a rule and inserting review a rule, or an order under section 4, ; (B) by striking such rule and inserting such rule or order ; (C) by striking the rule and inserting the rule or order ; (D) by striking new rule each place it appears and inserting new rule or order ; and (E) by striking modified rule and inserting modified rule or order ; and (3) in subsection (c)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking a rule and inserting a rule, or an order under section 4 ; and (II) by striking such rule and inserting such rule or order ; and (ii) in subparagraph (B)— (I) in the matter preceding clause (i), by striking a rule and inserting a rule or order ; (II) in clause (i)— (aa) by inserting or an order under section 4, before the standard for review ; (bb) by striking such rule and inserting such rule or order ; (cc) by striking the rule and inserting the rule or order ; and (dd) by striking the semicolon and inserting ; and ; and (III) by striking clause (ii) and redesignating clause (iii) as clause (ii); and (B) in paragraph (2), by striking any rule and inserting any rule or order . (k) Section 20 Section 20(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2619(a)(1) ) is amended by striking order issued under section 5 and inserting order issued under section 4 or 5 . (l) Section 21 Section 21 of the Toxic Substances Control Act ( 15 U.S.C. 2620 ) is amended— (1) in subsection (a), by striking order under section 5(e) or (6)(b)(2) and inserting order under section 4 or 5(e) ; and (2) in subsection (b)— (A) in paragraph (1), by striking order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B) and inserting order under section 4 or 5(e) ; and (B) in paragraph (4)(B)— (i) in the matter preceding clause (i), by striking order under section 5(e) or 6(b)(2) and inserting order under section 4 or 5(e) ; (ii) in clause (i), by striking order under section 5(e) and inserting order under section 4 or 5(e) ; and (iii) in clause (ii), by striking or an order under section 6(b)(2) . (m) Section 24 Section 24(b)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2623(b)(2)(B) ) is amended— (1) by inserting and at the end of clause (i); (2) by striking clause (ii); and (3) by redesignating clause (iii) as clause (ii). (n) Section 27 Section 27(a) of the Toxic Substances Control Act ( 15 U.S.C. 2626(a) ) is amended by striking rules promulgated and inserting rules, orders, or consent agreements . (o) Section 30 Section 30(2) of the Toxic Substances Control Act ( 15 U.S.C. 2629(2) ) is amended by striking rule and inserting rule, order, or consent agreement .

Passed the House of Representatives June 23, 2015. Karen L. Haas, Clerk.

tv_txt: II 114th CONGRESS 1st Session H. R. 2576 IN THE SENATE OF THE UNITED STATES June 24, 2015 Received AN ACT To modernize the Toxic Substances Control Act, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the TSCA Modernization Act of 2015 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Definitions. Sec. 3. Testing of chemical substances and mixtures. Sec. 4. Regulation of hazardous chemical substances and mixtures. Sec. 5. Relationship to other Federal laws. Sec. 6. Disclosure of data. Sec. 7. Effect on State law. Sec. 8. Administration of the Act. Sec. 9. Conforming amendments. 2. Definitions Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) by redesignating paragraphs (7) through (14) as paragraphs (8) through (10) and (12) through (16), respectively; (2) by inserting after paragraph (6) the following: (7) The term intended conditions of use means the circumstances under which a chemical substance is intended, known, or reasonably foreseeable to be manufactured, processed, distributed in commerce, used, and disposed of. ; and (3) by inserting after paragraph (10), as so redesignated, the following: (11) The term potentially exposed subpopulation means a group of individuals within the general population who, due to either greater susceptibility or greater potential exposure, are likely to be at greater risk than the general population of adverse health effects from exposure to a chemical substance. . 3. Testing of chemical substances and mixtures Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (A)(iii), by striking ; or and inserting a semicolon; (B) in subparagraph (B)(iii), by striking ; and and inserting ; or ; and (C) by adding at the end the following: (C) testing of a chemical substance is necessary to conduct a risk evaluation under section 6(b); and ; (2) in the matter following subsection (a)(2), by inserting , order, or consent agreement after by rule ; and (3) in subsection (b)(5), by striking paragraph (1)(A) or (1)(B) and inserting paragraph (1)(A), (1)(B), or (1)(C) . 4. Regulation of hazardous chemical substances and mixtures (a) Scope of regulation Section 6(a) of the Toxic Substances Control Act ( 15 U.S.C. 2605(a) ) is amended— (1) by striking finds that there is a reasonable basis to conclude and inserting determines under subsection (b) ; (2) by inserting or designates a chemical substance under subsection (i)(2), before the Administrator shall by rule ; and (3) by striking to protect adequately against such risk using the least burdensome requirements and inserting so that the chemical substance or mixture no longer presents or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulation . (b) Risk evaluations Section 6(b) of the Toxic Substances Control Act ( 15 U.S.C. 2605(b) ) is amended to read as follows: (b) Risk evaluations (1) In general The Administrator shall conduct risk evaluations pursuant to this subsection to determine whether or not a chemical substance presents or will present, in the absence of requirements under subsection (a), an unreasonable risk of injury to health or the environment. (2) Applying requirements The Administrator shall apply requirements with respect to a chemical substance through a rule under subsection (a) only if the Administrator determines through a risk evaluation under this subsection, without consideration of costs or other non-risk factors, that the chemical substance presents or will present, in the absence of such requirements, an unreasonable risk of injury to health or the environment. (3) Conducting risk evaluation (A) Required risk evaluations The Administrator shall conduct and publish the results of a risk evaluation under this subsection for a chemical substance if— (i) the Administrator determines that the chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use; or (ii) a manufacturer of the chemical substance requests such a risk evaluation in a form and manner prescribed by the Administrator. (B) TSCA Work Plan chemicals The Administrator may, without making a determination under subparagraph (A)(i), conduct and publish the results of a risk evaluation under this subsection for a chemical substance that, on the date of enactment of the TSCA Modernization Act of 2015 , is listed in the TSCA Work Plan for Chemical Assessments published by the Administrator. (4) Requirements In conducting a risk evaluation under this subsection, the Administrator shall— (A) integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed subpopulations; (B) not consider information on cost and other factors not directly related to health or the environment; (C) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance; (D) describe the weight of the scientific evidence for identified hazard and exposure; (E) consider whether the weight of the scientific evidence supports the identification of doses of the chemical substance below which no adverse effects can be expected to occur; and (F) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), ensure that the costs to the Environmental Protection Agency, including contractor costs, of conducting the risk evaluation are paid for by the manufacturer. (5) Deadlines (A) Risk evaluations The Administrator shall conduct and publish a risk evaluation under this subsection for a chemical substance as soon as reasonably possible, subject to the availability of resources, but not later than— (i) 3 years after the date on which the Administrator— (I) makes a determination under paragraph (3)(A)(i); or (II) begins the risk evaluation under paragraph (3)(B); or (ii) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), 2 years after the later of the date on which— (I) the manufacturer requests the risk evaluation; or (II) if applicable, the risk evaluation is initiated pursuant to subparagraph (B). (B) Deadline adjustment If the Administrator receives more requests for risk evaluations under paragraph (3)(A)(ii) than the Administrator has resources to conduct by the deadline under subparagraph (A)(ii)(I) (taking into account the requirement in paragraph (4)(F)), the Administrator shall— (i) initiate risk evaluations that exceed the Administrator’s allotted resources as soon as resources for such risk evaluations are available; and (ii) not collect a fee under section 26 from the manufacturer for a risk evaluation until the Administrator initiates the risk evaluation. (C) Subsection (a) rules If, based on a risk evaluation conducted under this subsection, the Administrator determines, without consideration of costs or other non-risk factors, that a chemical substance presents or will present, in the absence of a rule under subsection (a), an unreasonable risk of injury to health or the environment, the Administrator shall— (i) propose a rule under subsection (a) for the chemical substance not later than 1 year after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A); and (ii) publish in the Federal Register a final rule not later than 2 years after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A). (D) Extension If the Administrator determines that additional information is necessary to make a risk evaluation determination under this subsection, the Administrator may extend the deadline under subparagraph (A) accordingly, except that the deadline may not be extended to a date that is later than— (i) 90 days after receipt of such additional information; or (ii) 2 years after the deadline being extended under this subparagraph. (6) Determinations of no unreasonable risk (A) Notice and comment Not later than 30 days before publishing a final determination under this subsection that a chemical substance does not and will not present an unreasonable risk of injury to health or the environment, the Administrator shall make a preliminary determination to such effect and provide public notice of, and an opportunity for comment regarding, such preliminary determination. (B) Potentially exposed subpopulations The Administrator shall not make a determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment if the Administrator determines that the chemical substance, under the intended conditions of use, presents or will present an unreasonable risk of injury to one or more potentially exposed subpopulations. (C) Final action A final determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment shall be considered a final agency action. (7) Minimum number Subject to the availability of appropriations, the Administrator shall initiate 10 or more risk evaluations under paragraphs (3)(A)(i) or (3)(B) in each fiscal year beginning in the fiscal year of the date of enactment of the TSCA Modernization Act of 2015 . . (c) Promulgation of subsection (a) rules Section 6(c) of the Toxic Substances Control Act ( 15 U.S.C. 2605(c) ) is amended— (1) by amending paragraph (1) to read as follows: (1) Requirements for rule In promulgating any rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall— (A) consider and publish a statement with respect to— (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture; (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to the chemical substance or mixture; (iii) the benefits of the chemical substance or mixture for various uses; and (iv) the reasonably ascertainable economic consequences of the rule, including consideration of the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; (B) impose requirements under the rule that the Administrator determines, consistent with the information published under subparagraph (A), are cost-effective, except where the Administrator determines that additional or different requirements described in subsection (a) are necessary to protect against the identified risk; (C) based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific use of a chemical substance or mixture and in setting an appropriate transition period for such action, determine whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect; (D) exempt replacement parts designed prior to the date of publication in the Federal Register of the rule unless the Administrator finds such replacement parts contribute significantly to the identified risk, including identified risk to identified potentially exposed subpopulations; and (E) in selecting among prohibitions and other restrictions to address an identified risk, apply prohibitions or other restrictions to articles on the basis of a chemical substance or mixture contained in the article only to the extent necessary to protect against the identified risk. ; (2) in paragraph (2)— (A) by inserting Procedures. — before When prescribing a rule ; (B) by striking provide an opportunity for an informal hearing in accordance with paragraph (3); (D) ; (C) by striking , and (E) and inserting ; and (D) ; and (D) by moving such paragraph 2 ems to the right; (3) by striking paragraphs (3) and (4) and redesignating paragraph (5) as paragraph (3); and (4) in paragraph (3) (as so redesignated)— (A) by striking Paragraphs (1), (2), (3), and (4) and inserting Application.— Paragraphs (1) and (2) ; and (B) by moving such paragraph 2 ems to the right. (d) Effective date Section 6(d)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2605(d)(2)(B) ) is amended by adding at the end the following: Any rule promulgated under subsection (a) shall provide for a reasonable transition period. . (e) Non-Risk factors; critical use exemptions; PBT chemicals Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended by adding at the end the following: (g) Non-Risk factors The Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a). (h) Critical use exemptions (1) Criteria for exemption The Administrator may grant an exemption from a requirement of a subsection (a) rule for a specific use of a chemical substance or mixture, if— (A) the requirement is not cost-effective with respect to the specific use, as determined by the Administrator pursuant to subsection (c)(1)(B); and (B) the Administrator finds that— (i) the specific use is a critical or essential use; or (ii) the requirement, as applied with respect to the specific use, would significantly disrupt the national economy, national security, or critical infrastructure. (2) Procedure An exemption granted under paragraph (1) shall be— (A) supported by clear and convincing evidence; (B) preceded by public notice of the proposed exemption and an opportunity for comment; and (C) followed by notice of the granted exemption— (i) to the public, by the Administrator; and (ii) to known commercial purchasers of the chemical substance or mixture with respect to which the exemption applies, by the manufacturers and processors of such chemical substance or mixture. (3) Period of exemption An exemption granted under paragraph (1) shall expire after a period not to exceed 5 years, but may be renewed for one or more additional 5-year periods if the Administrator finds that the requirements of paragraph (1) continue to be met. (4) Conditions The Administrator shall impose conditions on any use for which an exemption is granted under paragraph (1) to reduce risk from the chemical substance or mixture to the greatest extent feasible. (i) Chemicals that are persistent, bioaccumulative, and toxic (1) Identification Not later than 9 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall publish a list of those chemical substances that the Administrator has a reasonable basis to conclude are persistent, bioaccumulative, and toxic, not including any chemical substance that is a metal, a metal compound, or subject to subsection (e). (2) Confirmation of concern Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall designate as a PBT chemical of concern each chemical substance on the list published under paragraph (1)— (A) that, with respect to persistence and bioaccumulation, scores high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012; and (B) exposure to which is likely to the general population or to a potentially exposed subpopulation identified by the Administrator. (3) Expedited action Notwithstanding subsection (b)(2), subject to the availability of appropriations, not later than 2 years after designating a chemical substance under paragraph (2), the Administrator shall promulgate a rule under subsection (a) with respect to the chemical substance to reduce likely exposure to the extent practicable. (4) Relationship to subsection (b) If, at any time prior to the date that is 90 days after the date on which the Administrator publishes the list under paragraph (1), the Administrator makes a finding under subsection (b)(3)(A)(i), or a manufacturer requests a risk evaluation under subsection (b)(3)(A)(ii), with respect to a chemical substance, such chemical substance shall not be subject to this subsection. . 5. Relationship to other Federal laws Section 9(b) of the Toxic Substances Control Act ( 15 U.S.C. 2608(b) ) is amended— (1) by striking The Administrator shall coordinate and inserting (1) The Administrator shall coordinate ; and (2) by adding at the end the following: (2) In making a determination under paragraph (1) that it is in the public interest for the Administrator to take an action under this title with respect to a chemical substance or mixture rather than under another law administered in whole or in part by the Administrator, the Administrator shall consider the relevant risks, and compare the estimated costs and efficiencies, of the action to be taken under this title and an action to be taken under such other law to protect against such risk. . 6. Disclosure of data Section 14 of the Toxic Substances Control Act ( 15 U.S.C. 2613 ) is amended— (1) in subsection (a)— (A) by striking or at the end of paragraph (3); (B) by striking the period at the end of paragraph (4) and inserting a semicolon; and (C) by adding after paragraph (4) the following new paragraphs: (5) may be disclosed to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law; and (6) shall be disclosed upon request— (A) to a health or environmental professional employed by a Federal or State agency in response to an environmental release; or (B) to a treating physician or other health care professional to assist in the diagnosis or treatment of one or more individuals. ; (2) in subsection (b)(1), in the matter following subparagraph (B)— (A) by striking data which discloses and inserting data that disclose formulas (including molecular structures) of a chemical substance or mixture, ; (B) by striking mixture or, and inserting mixture, or, ; and (C) by striking the release of data disclosing ; (3) in subsection (c)— (A) by striking the subsection heading and inserting Designating and substantiating confidentiality.— ; (B) by amending paragraph (1) to read as follows: (1) (A) In submitting information under this Act after date of enactment of the TSCA Modernization Act of 2015 , a manufacturer, processor, or distributor in commerce shall designate the information which such person believes is entitled to protection under this section, and submit such designated information separately from other information submitted under this Act. A designation under this subparagraph shall be made in writing and in such manner as the Administrator may prescribe, and shall include— (i) justification for each designation of confidentiality; (ii) a certification that the information is not otherwise publicly available; and (iii) separate copies of all submitted information, with one copy containing and one copy excluding the information to which the request applies. (B) Designations made under subparagraph (A) after the date of enactment of the TSCA Modernization Act of 2015 shall expire after 10 years, at which time the information shall be made public unless the manufacturer, processor, or distributor in commerce has reasserted the claim for protection, in writing and in such manner as the Administrator may prescribe, including all of the elements required for the initial submission. (C) Not later than 60 days prior to making information public under subparagraph (B), the Administrator shall notify, as appropriate and practicable, the manufacturer, processor, or distributor in commerce who designated the information under subparagraph (A) of the date on which such information will be made public unless a request for renewal is granted under subparagraph (B). ; and (C) in paragraph (2)— (i) in subparagraph (A), by inserting , for a reason other than the expiration of such designation pursuant to paragraph (1)(B), before proposes to release ; and (ii) in subparagraph (B)(i), by striking or (4) and inserting (4), or (6) ; and (4) by adding at the end the following new subsections: (f) Prohibition No person who receives information as permitted under subsection (a) may use such information for any purpose not specified in such subsection, nor disclose such information to any person not authorized to receive such information. (g) Savings Nothing in this section shall be construed to affect the applicability of State or Federal rules of evidence or procedure in any judicial proceeding. . 7. Effect on State law (a) In general Section 18(a) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a) ) is amended— (1) in paragraph (2)(A), by striking ; and and inserting a semicolon; (2) by striking paragraph (2)(B) and inserting the following: (B) if the Administrator makes a final determination under section 6(b) that a chemical substance will not present an unreasonable risk of injury to health or the environment under the intended condition of use, no State or political subdivision may, after the date of publication of such determination, establish or continue in effect any requirement that applies to such chemical substance under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b), and is designed to protect against exposure to such chemical substance under the intended conditions of use, unless the requirement of the State or political subdivision— (i) is adopted under the authority of a Federal law; or (ii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement; and (C) if the Administrator imposes a requirement, through a rule or order under section 5 or 6, that applies to a chemical substance or mixture (other than a requirement described in section 6(a)(6)) and is designed to protect against a risk of injury to health or the environment associated with such chemical substance or mixture, no State or political subdivision may, after the effective date of such requirement, establish or continue in effect any requirement that applies to such chemical substance or mixture (including a requirement that applies to an article because the article contains the chemical substance or mixture) and is designed to protect against exposure to the chemical substance or mixture either under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b) or from a use identified in a notice received by the Administrator under section 5(a), or, in the case of a requirement imposed pursuant to section 6(i), is designed to protect against a risk of injury considered by the Administrator in imposing such requirement, unless the requirement of the State or political subdivision— (i) is identical to the requirement imposed by the Administrator; (ii) is adopted under the authority of a Federal law; or (iii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement. ; and (3) by adding at the end the following: (3) In the case of an identical requirement described in paragraph (2)(C)(i)— (A) a State may not assess a penalty for a specific violation for which the Administrator has assessed a penalty under section 16; and (B) if a State has assessed a penalty for a specific violation, the Administrator 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 Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16. . (b) Savings Section 18 of the Toxic Substances Control Act ( 15 U.S.C. 2617 ) is amended by adding at the end the following: (c) Savings (1) Prior State actions Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken or requirement that has taken effect— (A) before August 1, 2015, under the authority of a State law that prohibits or otherwise restricts the manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or (B) pursuant to a State law that was in effect on August 31, 2003, unless an action or determination made by the Administrator under this title actually conflicts with the action taken or requirement that has taken effect pursuant to such a State law. (2) Tort and contract law Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect either Federal or State tort law or the law governing the interpretation of contracts of any State, including any remedy for civil relief, whether under statutory or common law, including a remedy for civil damages, and any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory relating to tort law. (3) Intent of Congress It is not the intent of Congress that this title, or rules, regulations, or orders issued pursuant to this title, be interpreted as influencing, in either a plaintiff’s or defendant’s favor, the disposition of any civil action for damages in a State court, or the authority of any court to make a determination in an adjudicatory proceeding under applicable State law with respect to the admissibility of evidence, unless a provision of this title actually conflicts with the State court action. (4) Application For purposes of this title, the term requirements does not include civil tort actions for damages under State law. . (c) Effect of actions by Administrator Nothing in this Act, or the amendments made by this Act, shall be construed as changing the preemptive effect of an action taken by the Administrator prior to the date of enactment of this Act or under section 6(e). 8. Administration of the Act Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) in subsection (b)(1)— (A) by striking of a reasonable fee ; (B) by inserting of a fee that is sufficient and not more than reasonably necessary after section 4 or 5 ; (C) by inserting , or who requests a risk evaluation under section 6(b)(3)(A)(ii), before to defray the cost ; (D) by striking this Act and inserting the provision of this title for which such fee is collected ; and (E) by striking Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. and inserting Such rules shall provide for lower fees for small business concerns. ; (2) by adding at the end of subsection (b) the following: (3) Fund (A) Establishment There is established in the Treasury of the United States a revolving fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the Fund ), consisting of such amounts as are deposited in the Fund under this paragraph. (B) Collection and deposit of fees The Administrator shall collect the fees described in paragraph (1) and deposit those fees in the Fund. (C) Crediting and availability of fees On request by the Administrator, the Secretary of the Treasury shall transfer from the Fund to the Administrator amounts appropriated to pay or recover the full costs incurred by the Environmental Protection Agency, including contractor costs, in carrying out the provisions of this title for which the fees are collected under paragraph (1). (D) Use of funds by Administrator Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation for use only in administering the provisions of this title for which the fees are collected. (E) Accounting and auditing (i) Accounting The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code. (ii) Auditing (I) In general For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency. (II) Components of audit The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of— (aa) the fees collected and amounts disbursed under this subsection; (bb) the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the title for which the fees are collected; and (cc) the number of requests for a risk evaluation made by manufacturers under section 6(b)(3)(A)(ii). (III) Federal responsibility The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit. ; and (3) by adding at the end the following: (h) Scientific standards In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall consider, as applicable— (1) the extent to which the scientific and technical procedures, measures, methods, or models employed to generate the information are reasonable for and consistent with the use of the information; (2) the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, or models, are evaluated and characterized; and (5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, or models. (i) Weight of scientific evidence The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence. (j) Availability of information Subject to section 14, the Administrator shall make available to the public all notices, determinations, findings, rules, and orders of the Administrator under this title. (k) Policies, procedures, and guidance (1) Development Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the TSCA Modernization Act of 2015 . (2) Review Not later than 5 years after the date of enactment of the TSCA Modernization Act of 2015 , and not less frequently than once every 5 years thereafter, the Administrator shall— (A) review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and (B) revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings. (l) Report to Congress (1) Initial report Not later than 6 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of— (A) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under subparagraphs (A)(i) and (B) of section 6(b)(3), and the resources necessary to initiate the minimum number of risk evaluations required under section 6(b)(7); (B) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(3)(A)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand; (C) the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and (D) the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b). (2) Subsequent reports The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years. . 9. Conforming amendments (a) Section 4 Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (b)— (A) in paragraph (1), by striking rule each place it appears and inserting rule, order, or consent agreement ; (B) in paragraph (2)(B), by striking rules and inserting rules, orders, and consent agreements ; (C) in paragraph (3), by striking rule each place it appears and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule under subsection (a) each place it appears and inserting rule, order, or consent agreement under subsection (a) ; (ii) by striking repeals the rule each place it appears and inserting repeals the rule or order or modifies the consent agreement to terminate the requirement ; and (iii) by striking repeals the application of the rule and inserting repeals or modifies the application of the rule, order, or consent agreement ; (2) in subsection (c)— (A) in paragraph (1), by striking rule and inserting rule or order ; (B) in paragraph (2)— (i) in subparagraph (A), by striking a rule under subsection (a) or for which data is being developed pursuant to such a rule and inserting a rule, order, or consent agreement under subsection (a) or for which data are being developed pursuant to such a rule, order, or consent agreement ; (ii) in subparagraph (B), by striking such rule or which is being developed pursuant to such rule and inserting such rule, order, or consent agreement or which is being developed pursuant to such rule, order, or consent agreement ; and (iii) in the matter following subparagraph (B), by striking the rule and inserting the rule or order ; (C) in paragraph (3)(B)(i), by striking rule promulgated and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule promulgated each place it appears and inserting rule, order, or consent agreement ; (ii) by striking such rule each place it appears and inserting such rule, order, or consent agreement ; and (iii) in subparagraph (B), by striking the rule and inserting the rule, order, or consent agreement ; (3) in subsection (d), by striking rule and inserting rule, order, or consent agreement ; and (4) in subsection (g), by striking rule and inserting rule, order, or consent agreement . (b) Section 5 Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) in subsection (b)— (A) in paragraph (1)(A)— (i) by striking rule promulgated and inserting rule, order, or consent agreement ; and (ii) by striking such rule and inserting such rule, order, or consent agreement ; (B) in paragraph (1)(B)— (i) by striking rule promulgated and inserting rule or order ; and (ii) by striking the date of the submission in accordance with such rule and inserting the required date of submission ; and (C) in paragraph (2)(A)(ii), by striking rule promulgated and inserting rule, order, or consent agreement ; (2) in subsection (d)(2)(C), by striking rule and inserting rule, order, or consent agreement ; and (3) in subsection (h)(4), by striking paragraphs (2) and (3) of section 6(c) and inserting paragraph (2) of section 6(c) . (c) Section 6 Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— (1) in subsection (d)(2)(B)— (A) by striking , provide reasonable opportunity, in accordance with paragraphs (2) and (3) of subsection (c), for a hearing on such rule, and inserting in accordance with paragraph (2) of subsection (c), ; and (B) by striking ; and if such a hearing is requested and all that follows through or revoke it. and inserting a period; and (2) in subsection (e)(4), by striking paragraphs (2), (3), and (4) of subsection (c) and inserting paragraph (2) of subsection (c) . (d) Section 7 Section 7(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2606(a)(1) ) is amended, in the matter following subparagraph (C), by striking a rule under section 4, 5, 6, or title IV or an order under section 5 or title IV and inserting a rule under section 4, 5, or 6 or title IV, an order under section 4 or 5 or title IV, or a consent agreement under section 4 . (e) Section 8 Section 8(a)(3)(A)(ii)(I) of the Toxic Substances Control Act ( 15 U.S.C. 2607(a)(3)(A)(ii)(I) ) is amended by striking or an order in effect under section 5(e) and inserting , an order in effect under section 4 or 5(e), or a consent agreement under section 4 . (f) Section 9 Section 9(a) of the Toxic Substances Control Act ( 15 U.S.C. 2608(a) ) is amended by striking section 6 each place it appears and inserting section 6(a) . (g) Section 11 Section 11(b)(2)(E) of the Toxic Substances Control Act ( 15 U.S.C. 2610(b)(2)(E) ) is amended by striking rule promulgated and inserting rule promulgated, order issued, or consent agreement entered into . (h) Section 15 Section 15(1) of the Toxic Substances Control Act ( 15 U.S.C. 2614(1) ) is amended by striking (A) any rule and all that follows through or (D) and inserting any requirement of this title or any rule promulgated, order issued, or consent agreement entered into under this title, or . (i) Section 18 Section 18(a)(2)(A) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a)(2)(A) ) is amended— (1) by striking rule promulgated and inserting rule, order, or consent agreement ; and (2) by striking such rule each place it appears and inserting such rule, order, or consent agreement . (j) Section 19 Section 19 of the Toxic Substances Control Act ( 15 U.S.C. 2618 ) is amended— (1) in subsection (a)— (A) in paragraph (1)(A)— (i) by striking (A) Not later than 60 days after the date of the promulgation of a rule and inserting Not later than 60 days after the date on which a rule is promulgated ; (ii) by inserting or the date on which an order is issued under section 4, before any person ; (iii) by striking such rule and inserting such rule or order ; and (iv) by striking such a rule and inserting such a rule or order ; (B) by striking paragraph (1)(B); (C) in paragraph (2), by striking the rule and inserting the rule or order ; and (D) in paragraph (3)— (i) in subparagraph (A), by striking the rule and inserting the rule or order ; (ii) in subparagraph (B), by striking a rule under section 4(a) and inserting a rule or order under section 4(a) ; (iii) in subparagraph (C), by striking such rule and inserting such rule or order ; (iv) in subparagraph (D), by striking such rule and inserting such rule or order ; and (v) in subparagraph (E)— (I) by striking to such rule and inserting to such rule or order ; and (II) by striking the date of the promulgation of such rule and inserting the date on which such rule is promulgated or such order is issued ; (2) in subsection (b)— (A) by striking review a rule and inserting review a rule, or an order under section 4, ; (B) by striking such rule and inserting such rule or order ; (C) by striking the rule and inserting the rule or order ; (D) by striking new rule each place it appears and inserting new rule or order ; and (E) by striking modified rule and inserting modified rule or order ; and (3) in subsection (c)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking a rule and inserting a rule, or an order under section 4 ; and (II) by striking such rule and inserting such rule or order ; and (ii) in subparagraph (B)— (I) in the matter preceding clause (i), by striking a rule and inserting a rule or order ; (II) in clause (i)— (aa) by inserting or an order under section 4, before the standard for review ; (bb) by striking such rule and inserting such rule or order ; (cc) by striking the rule and inserting the rule or order ; and (dd) by striking the semicolon and inserting ; and ; and (III) by striking clause (ii) and redesignating clause (iii) as clause (ii); and (B) in paragraph (2), by striking any rule and inserting any rule or order . (k) Section 20 Section 20(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2619(a)(1) ) is amended by striking order issued under section 5 and inserting order issued under section 4 or 5 . (l) Section 21 Section 21 of the Toxic Substances Control Act ( 15 U.S.C. 2620 ) is amended— (1) in subsection (a), by striking order under section 5(e) or (6)(b)(2) and inserting order under section 4 or 5(e) ; and (2) in subsection (b)— (A) in paragraph (1), by striking order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B) and inserting order under section 4 or 5(e) ; and (B) in paragraph (4)(B)— (i) in the matter preceding clause (i), by striking order under section 5(e) or 6(b)(2) and inserting order under section 4 or 5(e) ; (ii) in clause (i), by striking order under section 5(e) and inserting order under section 4 or 5(e) ; and (iii) in clause (ii), by striking or an order under section 6(b)(2) . (m) Section 24 Section 24(b)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2623(b)(2)(B) ) is amended— (1) by inserting and at the end of clause (i); (2) by striking clause (ii); and (3) by redesignating clause (iii) as clause (ii). (n) Section 27 Section 27(a) of the Toxic Substances Control Act ( 15 U.S.C. 2626(a) ) is amended by striking rules promulgated and inserting rules, orders, or consent agreements . (o) Section 30 Section 30(2) of the Toxic Substances Control Act ( 15 U.S.C. 2629(2) ) is amended by striking rule and inserting rule, order, or consent agreement .

Passed the House of Representatives June 23, 2015. Karen L. Haas, Clerk

tv_txt: IB Union Calendar No. 131 114th CONGRESS 1st Session H. R. 2576 [Report No. 114–176] IN THE HOUSE OF REPRESENTATIVES May 26, 2015 Mr. Shimkus (for himself, Mr. Upton , Mr. Pallone , and Mr. Tonko ) introduced the following bill; which was referred to the Committee on Energy and Commerce June 23, 2015 Additional sponsors: Mr. Harper , Mr. Gene Green of Texas , Mr. Latta , Mr. Bilirakis , Mr. Moolenaar , Mr. DesJarlais , Mr. Schweikert , Mr. Schrader , Ms. Schakowsky , Mr. Carter of Georgia , Mr. Richmond , Mr. Rush , and Mr. Thompson of Mississippi June 23, 2015 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed Strike out all after the enacting clause and insert the part printed in italic For text of introduced bill, see copy of bill as introduced on May 26, 2015 A BILL To modernize the Toxic Substances Control Act, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the TSCA Modernization Act of 2015 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Definitions. Sec. 3. Testing of chemical substances and mixtures. Sec. 4. Regulation of hazardous chemical substances and mixtures. Sec. 5. Relationship to other Federal laws. Sec. 6. Disclosure of data. Sec. 7. Effect on State law. Sec. 8. Administration of the Act. Sec. 9. Conforming amendments. 2. Definitions Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) by redesignating paragraphs (7) through (14) as paragraphs (8) through (10) and (12) through (16), respectively; (2) by inserting after paragraph (6) the following: (7) The term intended conditions of use means the circumstances under which a chemical substance is intended, known, or reasonably foreseeable to be manufactured, processed, distributed in commerce, used, and disposed of. ; and (3) by inserting after paragraph (10), as so redesignated, the following: (11) The term potentially exposed subpopulation means a group of individuals within the general population who, due to either greater susceptibility or greater potential exposure, are likely to be at greater risk than the general population of adverse health effects from exposure to a chemical substance. . 3. Testing of chemical substances and mixtures Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (A)(iii), by striking ; or and inserting a semicolon; (B) in subparagraph (B)(iii), by striking ; and and inserting ; or ; and (C) by adding at the end the following: (C) testing of a chemical substance is necessary to conduct a risk evaluation under section 6(b); and ; (2) in the matter following subsection (a)(2), by inserting , order, or consent agreement after by rule ; and (3) in subsection (b)(5), by striking paragraph (1)(A) or (1)(B) and inserting paragraph (1)(A), (1)(B), or (1)(C) . 4. Regulation of hazardous chemical substances and mixtures (a) Scope of regulation Section 6(a) of the Toxic Substances Control Act ( 15 U.S.C. 2605(a) ) is amended— (1) by striking finds that there is a reasonable basis to conclude and inserting determines under subsection (b) ; (2) by inserting or designates a chemical substance under subsection (i)(2), before the Administrator shall by rule ; and (3) by striking to protect adequately against such risk using the least burdensome requirements and inserting so that the chemical substance or mixture no longer presents or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulation . (b) Risk evaluations Section 6(b) of the Toxic Substances Control Act ( 15 U.S.C. 2605(b) ) is amended to read as follows: (b) Risk evaluations (1) In general The Administrator shall conduct risk evaluations pursuant to this subsection to determine whether or not a chemical substance presents or will present, in the absence of requirements under subsection (a), an unreasonable risk of injury to health or the environment. (2) Applying requirements The Administrator shall apply requirements with respect to a chemical substance through a rule under subsection (a) only if the Administrator determines through a risk evaluation under this subsection that the chemical substance presents or will present, in the absence of such requirements, an unreasonable risk of injury to health or the environment. (3) Conducting risk evaluation (A) Required risk evaluations The Administrator shall conduct and publish the results of a risk evaluation under this subsection for a chemical substance if— (i) the Administrator determines that the chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use; or (ii) a manufacturer of the chemical substance requests such a risk evaluation. (B) TSCA Work Plan chemicals The Administrator may, without making a determination under subparagraph (A)(i), conduct and publish the results of a risk evaluation under this subsection for a chemical substance that, on the date of enactment of the TSCA Modernization Act of 2015 , is listed in the TSCA Work Plan for Chemical Assessments published by the Administrator. (4) Requirements In conducting a risk evaluation under this subsection, the Administrator shall— (A) integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed subpopulations; (B) not consider information on cost and other factors not directly related to health or the environment; (C) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance; (D) describe the weight of the scientific evidence for identified hazard and exposure; (E) consider whether the weight of the scientific evidence supports the identification of doses of the chemical substance below which no adverse effects can be expected to occur; and (F) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), ensure that the costs to the Environmental Protection Agency, including contractor costs, of conducting the risk evaluation are paid for by the manufacturer. (5) Deadlines (A) Risk evaluations The Administrator shall conduct and publish a risk evaluation under this subsection for a chemical substance as soon as reasonably possible, subject to the availability of resources, but not later than 3 years after the date on which— (i) the Administrator— (I) makes a determination under paragraph (3)(A)(i); or (II) begins the risk evaluation under paragraph (3)(B); or (ii) a manufacturer requests the risk evaluation under paragraph (3)(A)(ii). (B) Subsection (a) rules If, based on a risk evaluation conducted under this subsection, the Administrator determines that a chemical substance presents or will present, in the absence of a rule under subsection (a), an unreasonable risk of injury to health or the environment, the Administrator shall— (i) propose a rule under subsection (a) for the chemical substance not later than 90 days after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A); and (ii) publish in the Federal Register a final rule not later than 180 days after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A). (C) Extension If the Administrator determines that additional information is necessary to make a risk evaluation determination under this subsection, the Administrator may extend the deadline under subparagraph (A) accordingly, except that the deadline may not be extended to a date that is later than— (i) 90 days after receipt of such additional information; or (ii) 2 years after the original deadline. (6) Determinations of no unreasonable risk (A) Notice and comment Not later than 30 days before publishing a final determination under this subsection that a chemical substance does not and will not present an unreasonable risk of injury to health or the environment, the Administrator shall make a preliminary determination to such effect and provide public notice of, and an opportunity for comment regarding, such preliminary determination. (B) Potentially exposed subpopulations The Administrator shall not make a determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment if the Administrator determines that the chemical substance, under the intended conditions of use, presents or will present an unreasonable risk of injury to 1 or more potentially exposed subpopulations. (C) Final action A final determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment shall be considered a final agency action. (7) Minimum number Subject to the availability of appropriations, the Administrator shall initiate 10 or more risk evaluations under paragraphs (3)(A)(i) or (3)(B) in each fiscal year beginning in the fiscal year of the date of enactment of the TSCA Modernization Act of 2015 . . (c) Promulgation of subsection (a) rules Section 6(c) of the Toxic Substances Control Act ( 15 U.S.C. 2605(c) ) is amended— (1) by amending paragraph (1) to read as follows: (1) Requirements for rule In promulgating any rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall— (A) consider and publish a statement with respect to— (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture; (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to the chemical substance or mixture; (iii) the benefits of the chemical substance or mixture for various uses; and (iv) the reasonably ascertainable economic consequences of the rule, including consideration of the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; (B) impose requirements under the rule that the Administrator determines, consistent with the information published under subparagraph (A), are cost-effective, except where the Administrator determines that additional or different requirements described in subsection (a) are necessary to protect against the identified risk; (C) based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific use of a chemical substance or mixture and in setting an appropriate transition period for such action, determine whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect; (D) exempt replacement parts designed prior to the date of publication in the Federal Register of the rule unless the Administrator finds such replacement parts contribute significantly to the identified risk, including identified risk to identified potentially exposed subpopulations; and (E) in selecting among prohibitions and other restrictions to address an identified risk, apply prohibitions or other restrictions to articles on the basis of a chemical substance or mixture contained in the article only to the extent necessary to protect against the identified risk. ; (2) in paragraph (2)— (A) by inserting Procedures. — before When prescribing a rule ; (B) by striking provide an opportunity for an informal hearing in accordance with paragraph (3); (D) ; (C) by striking , and (E) and inserting ; and (D) ; and (D) by moving such paragraph 2 ems to the right; (3) by striking paragraphs (3) and (4) and redesignating paragraph (5) as paragraph (3); and (4) in paragraph (3) (as so redesignated)— (A) by striking Paragraphs (1), (2), (3), and (4) and inserting Application.— Paragraphs (1) and (2) ; and (B) by moving such paragraph 2 ems to the right. (d) Effective date Section 6(d)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2605(d)(2)(B) ) is amended by adding at the end the following: Any rule promulgated under subsection (a) shall provide for a reasonable transition period. . (e) Non-risk factors; critical use exemptions; PBT chemicals Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended by adding at the end the following: (g) Non-risk factors The Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a). (h) Critical use exemptions (1) Criteria for exemption The Administrator may grant an exemption from a requirement of a subsection (a) rule for a specific use of a chemical substance or mixture, if— (A) the requirement is not cost-effective with respect to the specific use, as determined by the Administrator pursuant to subsection (c)(1)(B); and (B) the Administrator finds that— (i) the specific use is a critical or essential use; or (ii) the requirement, as applied with respect to the specific use, would significantly disrupt the national economy, national security, or critical infrastructure. (2) Procedure An exemption granted under paragraph (1) shall be— (A) supported by clear and convincing evidence; (B) preceded by public notice of the proposed exemption and an opportunity for comment; and (C) followed by notice of the granted exemption— (i) to the public, by the Administrator; and (ii) to known commercial purchasers of the chemical substance or mixture with respect to which the exemption applies, by the manufacturers and processors of such chemical substance or mixture. (3) Period of exemption An exemption granted under paragraph (1) shall expire after a period not to exceed 5 years, but may be renewed for one or more additional 5-year periods if the Administrator finds that the requirements of paragraph (1) continue to be met. (4) Conditions The Administrator shall impose conditions on any use for which an exemption is granted under paragraph (1) to reduce risk from the chemical substance or mixture to the greatest extent feasible. (i) Chemicals that are persistent, bioaccumulative, and toxic (1) Identification Not later than 9 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall publish a list of those chemical substances that the Administrator has a reasonable basis to conclude are persistent, bioaccumulative, and toxic, not including any chemical substance that is a metal, a metal compound, or subject to subsection (e). (2) Confirmation of concern Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall designate as a PBT chemical of concern each chemical substance on the list published under paragraph (1)— (A) that, with respect to persistence and bioaccumulation, scores high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012; and (B) exposure to which is likely to the general population or to a potentially exposed subpopulation identified by the Administrator. (3) Expedited action Notwithstanding subsection (b)(2), subject to the availability of appropriations, not later than 2 years after designating a chemical substance under paragraph (2), the Administrator shall promulgate a rule under subsection (a) with respect to the chemical substance to reduce likely exposure to the extent practicable. (4) Relationship to subsection (b) If, at any time prior to the date that is 90 days after the date on which the Administrator publishes the list under paragraph (1), the Administrator makes a finding under subsection (b)(3)(A)(i), or a manufacturer requests a risk evaluation under subsection (b)(3)(A)(ii), with respect to a chemical substance, such chemical substance shall not be subject to this subsection. . 5. Relationship to other Federal laws Section 9(b) of the Toxic Substances Control Act ( 15 U.S.C. 2608(b) ) is amended— (1) by striking The Administrator shall coordinate and inserting (1) The Administrator shall coordinate ; and (2) by adding at the end the following: (2) In making a determination under paragraph (1) that it is in the public interest for the Administrator to take an action under this title with respect to a chemical substance or mixture rather than under another law administered in whole or in part by the Administrator, the Administrator shall consider the relevant risks, and compare the estimated costs and efficiencies, of the action to be taken under this title and an action to be taken under such other law to protect against such risk. . 6. Disclosure of data Section 14 of the Toxic Substances Control Act ( 15 U.S.C. 2613 ) is amended— (1) in subsection (a)— (A) by striking or at the end of paragraph (3); (B) by striking the period at the end of paragraph (4) and inserting a semicolon; and (C) by adding after paragraph (4) the following new paragraphs: (5) may be disclosed to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law; and (6) shall be disclosed upon request— (A) to a health or environmental professional employed by a Federal or State agency in response to an environmental release; or (B) to a treating physician or other health care professional to assist in the diagnosis or treatment of 1 or more individuals. ; (2) in subsection (b)(1), in the matter following subparagraph (B)— (A) by striking data which discloses and inserting data that disclose formulas (including molecular structures) of a chemical substance or mixture, ; (B) by striking mixture or, and inserting mixture, or, ; and (C) by striking the release of data disclosing ; (3) in subsection (c)— (A) by striking the subsection heading and inserting Designating and substantiating confidentiality.— ; (B) by amending paragraph (1) to read as follows: (1) (A) In submitting information under this Act after date of enactment of the TSCA Modernization Act of 2015 , a manufacturer, processor, or distributor in commerce shall designate the information which such person believes is entitled to protection under this section, and submit such designated information separately from other information submitted under this Act. A designation under this subparagraph shall be made in writing and in such manner as the Administrator may prescribe, and shall include— (i) justification for each designation of confidentiality; (ii) a certification that the information is not otherwise publicly available; and (iii) separate copies of all submitted information, with 1 copy containing and 1 copy excluding the information to which the request applies. (B) Designations made under subparagraph (A) after the date of enactment of the TSCA Modernization Act of 2015 shall expire after 10 years, at which time the information shall be made public unless the manufacturer, processor, or distributor in commerce has reasserted the claim for protection, in writing and in such manner as the Administrator may prescribe, including all of the elements required for the initial submission. (C) Not later than 60 days prior to making information public under subparagraph (B), the Administrator shall notify, as appropriate and practicable, the manufacturer, processor, or distributor in commerce who designated the information under subparagraph (A) of the date on which such information will be made public unless a request for renewal is granted under subparagraph (B). ; and (C) in paragraph (2)— (i) in subparagraph (A), by inserting , for a reason other than the expiration of such designation pursuant to paragraph (1)(B), before proposes to release ; and (ii) in subparagraph (B)(i), by striking or (4) and inserting (4), or (6) ; and (4) by adding at the end the following new subsections: (f) Prohibition No person who receives information as permitted under subsection (a) may use such information for any purpose not specified in such subsection, nor disclose such information to any person not authorized to receive such information. (g) Savings Nothing in this section shall be construed to affect the applicability of State or Federal rules of evidence or procedure in any judicial proceeding. . 7. Effect on State law (a) In general Section 18(a) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a) ) is amended— (1) in paragraph (2)(A), by striking ; and and inserting a semicolon; (2) by striking paragraph (2)(B) and inserting the following: (B) if the Administrator makes a final determination under section 6(b) that a chemical substance will not present an unreasonable risk of injury to health or the environment under the intended condition of use, no State or political subdivision may, after the date of publication of such determination, establish or continue in effect any requirement that applies to such chemical substance under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b), and is designed to protect against exposure to such chemical substance under the intended conditions of use, unless the requirement of the State or political subdivision— (i) is adopted under the authority of a Federal law; or (ii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement; and (C) if the Administrator imposes a requirement, through a rule or order under section 5 or 6, that applies to a chemical substance or mixture (other than a requirement described in section 6(a)(6)) and is designed to protect against a risk of injury to health or the environment associated with such chemical substance or mixture, no State or political subdivision may, after the effective date of such requirement, establish or continue in effect any requirement that applies to such chemical substance or mixture (including a requirement that applies to an article because the article contains the chemical substance or mixture) and is designed to protect against exposure to the chemical substance or mixture either under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b) or from a use identified in a notice received by the Administrator under section 5(a), or, in the case of a requirement imposed pursuant to section 6(i), is designed to protect against a risk of injury considered by the Administrator in imposing such requirement, unless the requirement of the State or political subdivision— (i) is identical to the requirement imposed by the Administrator; (ii) is adopted under the authority of a Federal law; or (iii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement. ; and (3) by adding at the end the following: (3) In the case of an identical requirement described in paragraph (2)(C)(i)— (A) a State may not assess a penalty for a specific violation for which the Administrator has assessed a penalty under section 16; and (B) if a State has assessed a penalty for a specific violation, the Administrator 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 Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16. . (b) Savings Section 18 of the Toxic Substances Control Act ( 15 U.S.C. 2617 ) is amended by adding at the end the following: (c) Savings (1) Prior State actions Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken before August 1, 2015, under the authority of a State law that prohibits or otherwise restricts the manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance, or any action taken pursuant to a State law that was in effect on August 31, 2003, unless an action or determination made by the Administrator under this title actually conflicts with the action taken pursuant to such a State law. (2) Tort and contract law Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect either Federal or State tort law or the law governing the interpretation of contracts of any State, including any remedy for civil relief, whether under statutory or common law, including a remedy for civil damages, and any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory relating to tort law. (3) Intent of Congress It is not the intent of Congress that this title, or rules, regulations, or orders issued pursuant to this title, be interpreted as influencing, in either a plaintiff’s or defendant’s favor, the disposition of any civil action for damages in a State court, or the authority of any court to make a determination in an adjudicatory proceeding under applicable State law with respect to the admissibility of evidence, unless a provision of this title actually conflicts with the State court action. (4) Application For purposes of this title, the term requirements does not include civil tort actions for damages under State law. . (c) Effect of actions by Administrator Nothing in this Act, or the amendments made by this Act, shall be construed as changing the preemptive effect of an action taken by the Administrator prior to the date of enactment of this Act or under section 6(e). 8. Administration of the Act Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) in subsection (b)(1)— (A) by striking of a reasonable fee ; (B) by inserting of a fee that is sufficient and not more than reasonably necessary after section 4 or 5 ; (C) by inserting , or who requests a risk evaluation under section 6(b)(3)(A)(ii), before to defray the cost ; (D) by striking this Act and inserting the provision of this title for which such fee is collected ; and (E) by striking Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. and inserting Such rules shall provide for lower fees for small business concerns. ; (2) by adding at the end of subsection (b) the following: (3) Fund (A) Establishment There is established in the Treasury of the United States a revolving fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the Fund ), consisting of such amounts as are deposited in the Fund under this paragraph. (B) Collection and deposit of fees The Administrator shall collect the fees described in paragraph (1) and deposit those fees in the Fund. (C) Crediting and availability of fees On request by the Administrator, the Secretary of the Treasury shall transfer from the Fund to the Administrator amounts appropriated to pay or recover the full costs incurred by the Environmental Protection Agency, including contractor costs, in carrying out the provisions of this title for which the fees are collected under paragraph (1). (D) Use of funds by Administrator Amounts equivalent to fees collected by the Administrator and deposited in the Fund under this section shall be available without fiscal year limitation to the Administrator, subject to the availability of appropriations, for use only in administering the provisions of this title for which the fees are collected. (E) Accounting and auditing (i) Accounting The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code. (ii) Auditing (I) In general For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency. (II) Components of audit The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of— (aa) the fees collected and amounts disbursed under this subsection; (bb) the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the title for which the fees are collected; and (cc) the number of requests for a risk evaluation made by manufacturers under section 6(b)(3)(A)(ii). (III) Federal responsibility The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit. ; and (3) by adding at the end the following: (h) Scientific standards In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall consider, as applicable— (1) the extent to which the scientific and technical procedures, measures, methods, or models employed to generate the information are reasonable for and consistent with the use of the information; (2) the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, or models, are evaluated and characterized; and (5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, or models. (i) Weight of scientific evidence The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence. (j) Availability of information Subject to section 14, the Administrator shall make available to the public all notices, determinations, findings, rules, and orders of the Administrator under this title. (k) Policies, procedures, and guidance (1) Development Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the TSCA Modernization Act of 2015 . (2) Review Not later than 5 years after the date of enactment of the TSCA Modernization Act of 2015 , and not less frequently than once every 5 years thereafter, the Administrator shall— (A) review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and (B) revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings. (l) Report to Congress (1) Initial report Not later than 6 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of— (A) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under subparagraphs (A)(i) and (B) of section 6(b)(3), and the resources necessary to initiate the minimum number of risk evaluations required under section 6(b)(7); (B) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(3)(A)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand; (C) the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and (D) the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b). (2) Subsequent reports The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years. . 9. Conforming amendments (a) Section 4 Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (b)— (A) in paragraph (1), by striking rule each place it appears and inserting rule, order, or consent agreement ; (B) in paragraph (2)(B), by striking rules and inserting rules, orders, and consent agreements ; (C) in paragraph (3), by striking rule each place it appears and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule under subsection (a) each place it appears and inserting rule, order, or consent agreement under subsection (a) ; (ii) by striking repeals the rule each place it appears and inserting repeals the rule or order or modifies the consent agreement to terminate the requirement ; and (iii) by striking repeals the application of the rule and inserting repeals or modifies the application of the rule, order, or consent agreement ; (2) in subsection (c)— (A) in paragraph (1), by striking rule and inserting rule or order ; (B) in paragraph (2)— (i) in subparagraph (A), by striking a rule under subsection (a) or for which data is being developed pursuant to such a rule and inserting a rule, order, or consent agreement under subsection (a) or for which data is being developed pursuant to such a rule, order, or consent agreement ; (ii) in subparagraph (B), by striking such rule or which is being developed pursuant to such rule and inserting such rule, order, or consent agreement or which is being developed pursuant to such rule, order, or consent agreement ; and (iii) in the matter following subparagraph (B), by striking the rule and inserting the rule or order ; (C) in paragraph (3)(B)(i), by striking rule promulgated and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule promulgated each place it appears and inserting rule, order, or consent agreement ; (ii) by striking such rule each place it appears and inserting such rule, order, or consent agreement ; and (iii) in subparagraph (B), by striking the rule and inserting the rule, order, or consent agreement ; (3) in subsection (d), by striking rule and inserting rule, order, or consent agreement ; and (4) in subsection (g), by striking rule and inserting rule, order, or consent agreement . (b) Section 5 Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) in subsection (b)— (A) in paragraph (1)(A)— (i) by striking rule promulgated and inserting rule, order, or consent agreement ; and (ii) by striking such rule and inserting such rule, order, or consent agreement ; (B) in paragraph (1)(B)— (i) by striking rule promulgated and inserting rule or order ; and (ii) by striking the date of the submission in accordance with such rule and inserting the required date of submission ; and (C) in paragraph (2)(A)(ii), by striking rule promulgated and inserting rule, order, or consent agreement ; (2) in subsection (d)(2)(C), by striking rule and inserting rule, order, or consent agreement ; and (3) in subsection (h)(4), by striking paragraphs (2) and (3) of section 6(c) and inserting paragraph (2) of section 6(c) . (c) Section 6 Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— (1) in subsection (d)(2)(B)— (A) by striking , provide reasonable opportunity, in accordance with paragraphs (2) and (3) of subsection (c), for a hearing on such rule, and inserting in accordance with paragraph (2) of subsection (c), ; and (B) by striking ; and if such a hearing is requested and all that follows through or revoke it. and inserting a period; and (2) in subsection (e)(4), by striking paragraphs (2), (3), and (4) of subsection (c) and inserting paragraph (2) of subsection (c) . (d) Section 7 Section 7(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2606(a)(1) ) is amended, in the matter following subparagraph (C), by striking a rule under section 4, 5, 6, or title IV or an order under section 5 or title IV and inserting a rule under section 4, 5, or 6 or title IV, an order under section 4 or 5 or title IV, or a consent agreement under section 4 . (e) Section 8 Section 8(a)(3)(A)(ii)(I) of the Toxic Substances Control Act ( 15 U.S.C. 2607(a)(3)(A)(ii)(I) ) is amended by striking or an order in effect under section 5(e) and inserting , an order in effect under section 4 or 5(e), or a consent agreement under section 4 . (f) Section 9 Section 9(a) of the Toxic Substances Control Act ( 15 U.S.C. 2608(a) ) is amended by striking section 6 each place it appears and inserting section 6(a) . (g) Section 11 Section 11(b)(2)(E) of the Toxic Substances Control Act ( 15 U.S.C. 2610(b)(2)(E) ) is amended by striking rule promulgated and inserting rule promulgated, order issued, or consent agreement entered into . (h) Section 15 Section 15(1) of the Toxic Substances Control Act ( 15 U.S.C. 2614(1) ) is amended by striking (A) any rule and all that follows through or (D) and inserting any requirement of this title or any rule promulgated, order issued, or consent agreement entered into under this title, or . (i) Section 18 Section 18(a)(2)(A) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a)(2)(A) ) is amended— (1) by striking rule promulgated and inserting rule, order, or consent agreement ; and (2) by striking such rule each place it appears and inserting such rule, order, or consent agreement . (j) Section 19 Section 19 of the Toxic Substances Control Act ( 15 U.S.C. 2618 ) is amended— (1) in subsection (a)— (A) in paragraph (1)(A)— (i) by striking (A) Not later than 60 days after the date of the promulgation of a rule and inserting Not later than 60 days after the date on which a rule is promulgated ; (ii) by inserting or the date on which an order is issued under section 4, before any person ; (iii) by striking such rule and inserting such rule or order ; and (iv) by striking such a rule and inserting such a rule or order ; (B) by striking paragraph (1)(B); (C) in paragraph (2), by striking the rule and inserting the rule or order ; and (D) in paragraph (3)— (i) in subparagraph (A), by striking the rule and inserting the rule or order ; (ii) in subparagraph (B), by striking a rule under section 4(a) and inserting a rule or order under section 4(a) ; (iii) in subparagraph (C), by striking such rule and inserting such rule or order ; (iv) in subparagraph (D), by striking such rule and inserting such rule or order ; and (v) in subparagraph (E)— (I) by striking to such rule and inserting to such rule or order ; and (II) by striking the date of the promulgation of such rule and inserting the date on which such rule is promulgated or such order is issued ; (2) in subsection (b)— (A) by striking review a rule and inserting review a rule, or an order under section 4, ; (B) by striking such rule and inserting such rule or order ; (C) by striking the rule and inserting the rule or order ; (D) by striking new rule each place it appears and inserting new rule or order ; and (E) by striking modified rule and inserting modified rule or order ; and (3) in subsection (c)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking a rule and inserting a rule, or an order under section 4 ; and (II) by striking such rule and inserting such rule or order ; and (ii) in subparagraph (B)— (I) in the matter preceding clause (i), by striking a rule and inserting a rule or order ; (II) in clause (i)— (aa) by inserting or an order under section 4, before the standard for review ; (bb) by striking such rule and inserting such rule or order ; (cc) by striking the rule and inserting the rule or order ; and (dd) by striking the semicolon and inserting ; and ; and (III) by striking clause (ii) and redesignating clause (iii) as clause (ii); and (B) in paragraph (2), by striking any rule and inserting any rule or order . (k) Section 20 Section 20(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2619(a)(1) ) is amended by striking order issued under section 5 and inserting order issued under section 4 or 5 . (l) Section 21 Section 21 of the Toxic Substances Control Act ( 15 U.S.C. 2620 ) is amended— (1) in subsection (a), by striking order under section 5(e) or (6)(b)(2) and inserting order under section 4 or 5(e) ; and (2) in subsection (b)— (A) in paragraph (1), by striking order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B) and inserting order under section 4 or 5(e) ; and (B) in paragraph (4)(B)— (i) in the matter preceding clause (i), by striking order under section 5(e) or 6(b)(2) and inserting order under section 4 or 5(e) ; (ii) in clause (i), by striking order under section 5(e) and inserting order under section 4 or 5(e) ; and (iii) in clause (ii), by striking or an order under section 6(b)(2) . (m) Section 24 Section 24(b)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2623(b)(2)(B) ) is amended— (1) by inserting and at the end of clause (i); (2) by striking clause (ii); and (3) by redesignating clause (iii) as clause (ii). (n) Section 27 Section 27(a) of the Toxic Substances Control Act ( 15 U.S.C. 2626(a) ) is amended by striking rules promulgated and inserting rules, orders, or consent agreements . (o) Section 30 Section 30(2) of the Toxic Substances Control Act ( 15 U.S.C. 2629(2) ) is amended by striking rule and inserting rule, order, or consent agreement .

June 23, 2015 Reported with an amendment, committed to the Committee of the Whole House on the State of the Union, and ordered to be printed

tv_txt: II Calendar No. 143 114th CONGRESS 1st Session H. R. 2576 IN THE SENATE OF THE UNITED STATES June 24, 2015 Received July 8, 2015 Read twice and placed on the calendar AN ACT To modernize the Toxic Substances Control Act, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the TSCA Modernization Act of 2015 . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. Sec. 2. Definitions. Sec. 3. Testing of chemical substances and mixtures. Sec. 4. Regulation of hazardous chemical substances and mixtures. Sec. 5. Relationship to other Federal laws. Sec. 6. Disclosure of data. Sec. 7. Effect on State law. Sec. 8. Administration of the Act. Sec. 9. Conforming amendments. 2. Definitions Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) by redesignating paragraphs (7) through (14) as paragraphs (8) through (10) and (12) through (16), respectively; (2) by inserting after paragraph (6) the following: (7) The term intended conditions of use means the circumstances under which a chemical substance is intended, known, or reasonably foreseeable to be manufactured, processed, distributed in commerce, used, and disposed of. ; and (3) by inserting after paragraph (10), as so redesignated, the following: (11) The term potentially exposed subpopulation means a group of individuals within the general population who, due to either greater susceptibility or greater potential exposure, are likely to be at greater risk than the general population of adverse health effects from exposure to a chemical substance. . 3. Testing of chemical substances and mixtures Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (a)(1)— (A) in subparagraph (A)(iii), by striking ; or and inserting a semicolon; (B) in subparagraph (B)(iii), by striking ; and and inserting ; or ; and (C) by adding at the end the following: (C) testing of a chemical substance is necessary to conduct a risk evaluation under section 6(b); and ; (2) in the matter following subsection (a)(2), by inserting , order, or consent agreement after by rule ; and (3) in subsection (b)(5), by striking paragraph (1)(A) or (1)(B) and inserting paragraph (1)(A), (1)(B), or (1)(C) . 4. Regulation of hazardous chemical substances and mixtures (a) Scope of regulation Section 6(a) of the Toxic Substances Control Act ( 15 U.S.C. 2605(a) ) is amended— (1) by striking finds that there is a reasonable basis to conclude and inserting determines under subsection (b) ; (2) by inserting or designates a chemical substance under subsection (i)(2), before the Administrator shall by rule ; and (3) by striking to protect adequately against such risk using the least burdensome requirements and inserting so that the chemical substance or mixture no longer presents or will present an unreasonable risk, including an identified unreasonable risk to a potentially exposed subpopulation . (b) Risk evaluations Section 6(b) of the Toxic Substances Control Act ( 15 U.S.C. 2605(b) ) is amended to read as follows: (b) Risk evaluations (1) In general The Administrator shall conduct risk evaluations pursuant to this subsection to determine whether or not a chemical substance presents or will present, in the absence of requirements under subsection (a), an unreasonable risk of injury to health or the environment. (2) Applying requirements The Administrator shall apply requirements with respect to a chemical substance through a rule under subsection (a) only if the Administrator determines through a risk evaluation under this subsection, without consideration of costs or other non-risk factors, that the chemical substance presents or will present, in the absence of such requirements, an unreasonable risk of injury to health or the environment. (3) Conducting risk evaluation (A) Required risk evaluations The Administrator shall conduct and publish the results of a risk evaluation under this subsection for a chemical substance if— (i) the Administrator determines that the chemical substance may present an unreasonable risk of injury to health or the environment because of potential hazard and a potential route of exposure under the intended conditions of use; or (ii) a manufacturer of the chemical substance requests such a risk evaluation in a form and manner prescribed by the Administrator. (B) TSCA Work Plan chemicals The Administrator may, without making a determination under subparagraph (A)(i), conduct and publish the results of a risk evaluation under this subsection for a chemical substance that, on the date of enactment of the TSCA Modernization Act of 2015 , is listed in the TSCA Work Plan for Chemical Assessments published by the Administrator. (4) Requirements In conducting a risk evaluation under this subsection, the Administrator shall— (A) integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed subpopulations; (B) not consider information on cost and other factors not directly related to health or the environment; (C) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical substance; (D) describe the weight of the scientific evidence for identified hazard and exposure; (E) consider whether the weight of the scientific evidence supports the identification of doses of the chemical substance below which no adverse effects can be expected to occur; and (F) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), ensure that the costs to the Environmental Protection Agency, including contractor costs, of conducting the risk evaluation are paid for by the manufacturer. (5) Deadlines (A) Risk evaluations The Administrator shall conduct and publish a risk evaluation under this subsection for a chemical substance as soon as reasonably possible, subject to the availability of resources, but not later than— (i) 3 years after the date on which the Administrator— (I) makes a determination under paragraph (3)(A)(i); or (II) begins the risk evaluation under paragraph (3)(B); or (ii) in the case of a risk evaluation requested by a manufacturer under paragraph (3)(A)(ii), 2 years after the later of the date on which— (I) the manufacturer requests the risk evaluation; or (II) if applicable, the risk evaluation is initiated pursuant to subparagraph (B). (B) Deadline adjustment If the Administrator receives more requests for risk evaluations under paragraph (3)(A)(ii) than the Administrator has resources to conduct by the deadline under subparagraph (A)(ii)(I) (taking into account the requirement in paragraph (4)(F)), the Administrator shall— (i) initiate risk evaluations that exceed the Administrator’s allotted resources as soon as resources for such risk evaluations are available; and (ii) not collect a fee under section 26 from the manufacturer for a risk evaluation until the Administrator initiates the risk evaluation. (C) Subsection (a) rules If, based on a risk evaluation conducted under this subsection, the Administrator determines, without consideration of costs or other non-risk factors, that a chemical substance presents or will present, in the absence of a rule under subsection (a), an unreasonable risk of injury to health or the environment, the Administrator shall— (i) propose a rule under subsection (a) for the chemical substance not later than 1 year after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A); and (ii) publish in the Federal Register a final rule not later than 2 years after the date on which the risk evaluation regarding such chemical substance is published under subparagraph (A). (D) Extension If the Administrator determines that additional information is necessary to make a risk evaluation determination under this subsection, the Administrator may extend the deadline under subparagraph (A) accordingly, except that the deadline may not be extended to a date that is later than— (i) 90 days after receipt of such additional information; or (ii) 2 years after the deadline being extended under this subparagraph. (6) Determinations of no unreasonable risk (A) Notice and comment Not later than 30 days before publishing a final determination under this subsection that a chemical substance does not and will not present an unreasonable risk of injury to health or the environment, the Administrator shall make a preliminary determination to such effect and provide public notice of, and an opportunity for comment regarding, such preliminary determination. (B) Potentially exposed subpopulations The Administrator shall not make a determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment if the Administrator determines that the chemical substance, under the intended conditions of use, presents or will present an unreasonable risk of injury to one or more potentially exposed subpopulations. (C) Final action A final determination under this subsection that a chemical substance will not present an unreasonable risk of injury to health or the environment shall be considered a final agency action. (7) Minimum number Subject to the availability of appropriations, the Administrator shall initiate 10 or more risk evaluations under paragraphs (3)(A)(i) or (3)(B) in each fiscal year beginning in the fiscal year of the date of enactment of the TSCA Modernization Act of 2015 . . (c) Promulgation of subsection (a) rules Section 6(c) of the Toxic Substances Control Act ( 15 U.S.C. 2605(c) ) is amended— (1) by amending paragraph (1) to read as follows: (1) Requirements for rule In promulgating any rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall— (A) consider and publish a statement with respect to— (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture; (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to the chemical substance or mixture; (iii) the benefits of the chemical substance or mixture for various uses; and (iv) the reasonably ascertainable economic consequences of the rule, including consideration of the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; (B) impose requirements under the rule that the Administrator determines, consistent with the information published under subparagraph (A), are cost-effective, except where the Administrator determines that additional or different requirements described in subsection (a) are necessary to protect against the identified risk; (C) based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific use of a chemical substance or mixture and in setting an appropriate transition period for such action, determine whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect; (D) exempt replacement parts designed prior to the date of publication in the Federal Register of the rule unless the Administrator finds such replacement parts contribute significantly to the identified risk, including identified risk to identified potentially exposed subpopulations; and (E) in selecting among prohibitions and other restrictions to address an identified risk, apply prohibitions or other restrictions to articles on the basis of a chemical substance or mixture contained in the article only to the extent necessary to protect against the identified risk. ; (2) in paragraph (2)— (A) by inserting Procedures. — before When prescribing a rule ; (B) by striking provide an opportunity for an informal hearing in accordance with paragraph (3); (D) ; (C) by striking , and (E) and inserting ; and (D) ; and (D) by moving such paragraph 2 ems to the right; (3) by striking paragraphs (3) and (4) and redesignating paragraph (5) as paragraph (3); and (4) in paragraph (3) (as so redesignated)— (A) by striking Paragraphs (1), (2), (3), and (4) and inserting Application.— Paragraphs (1) and (2) ; and (B) by moving such paragraph 2 ems to the right. (d) Effective date Section 6(d)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2605(d)(2)(B) ) is amended by adding at the end the following: Any rule promulgated under subsection (a) shall provide for a reasonable transition period. . (e) Non-Risk factors; critical use exemptions; PBT chemicals Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended by adding at the end the following: (g) Non-Risk factors The Administrator shall not consider costs or other non-risk factors when deciding whether to initiate a rulemaking under subsection (a). (h) Critical use exemptions (1) Criteria for exemption The Administrator may grant an exemption from a requirement of a subsection (a) rule for a specific use of a chemical substance or mixture, if— (A) the requirement is not cost-effective with respect to the specific use, as determined by the Administrator pursuant to subsection (c)(1)(B); and (B) the Administrator finds that— (i) the specific use is a critical or essential use; or (ii) the requirement, as applied with respect to the specific use, would significantly disrupt the national economy, national security, or critical infrastructure. (2) Procedure An exemption granted under paragraph (1) shall be— (A) supported by clear and convincing evidence; (B) preceded by public notice of the proposed exemption and an opportunity for comment; and (C) followed by notice of the granted exemption— (i) to the public, by the Administrator; and (ii) to known commercial purchasers of the chemical substance or mixture with respect to which the exemption applies, by the manufacturers and processors of such chemical substance or mixture. (3) Period of exemption An exemption granted under paragraph (1) shall expire after a period not to exceed 5 years, but may be renewed for one or more additional 5-year periods if the Administrator finds that the requirements of paragraph (1) continue to be met. (4) Conditions The Administrator shall impose conditions on any use for which an exemption is granted under paragraph (1) to reduce risk from the chemical substance or mixture to the greatest extent feasible. (i) Chemicals that are persistent, bioaccumulative, and toxic (1) Identification Not later than 9 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall publish a list of those chemical substances that the Administrator has a reasonable basis to conclude are persistent, bioaccumulative, and toxic, not including any chemical substance that is a metal, a metal compound, or subject to subsection (e). (2) Confirmation of concern Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall designate as a PBT chemical of concern each chemical substance on the list published under paragraph (1)— (A) that, with respect to persistence and bioaccumulation, scores high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012; and (B) exposure to which is likely to the general population or to a potentially exposed subpopulation identified by the Administrator. (3) Expedited action Notwithstanding subsection (b)(2), subject to the availability of appropriations, not later than 2 years after designating a chemical substance under paragraph (2), the Administrator shall promulgate a rule under subsection (a) with respect to the chemical substance to reduce likely exposure to the extent practicable. (4) Relationship to subsection (b) If, at any time prior to the date that is 90 days after the date on which the Administrator publishes the list under paragraph (1), the Administrator makes a finding under subsection (b)(3)(A)(i), or a manufacturer requests a risk evaluation under subsection (b)(3)(A)(ii), with respect to a chemical substance, such chemical substance shall not be subject to this subsection. . 5. Relationship to other Federal laws Section 9(b) of the Toxic Substances Control Act ( 15 U.S.C. 2608(b) ) is amended— (1) by striking The Administrator shall coordinate and inserting (1) The Administrator shall coordinate ; and (2) by adding at the end the following: (2) In making a determination under paragraph (1) that it is in the public interest for the Administrator to take an action under this title with respect to a chemical substance or mixture rather than under another law administered in whole or in part by the Administrator, the Administrator shall consider the relevant risks, and compare the estimated costs and efficiencies, of the action to be taken under this title and an action to be taken under such other law to protect against such risk. . 6. Disclosure of data Section 14 of the Toxic Substances Control Act ( 15 U.S.C. 2613 ) is amended— (1) in subsection (a)— (A) by striking or at the end of paragraph (3); (B) by striking the period at the end of paragraph (4) and inserting a semicolon; and (C) by adding after paragraph (4) the following new paragraphs: (5) may be disclosed to a State, local, or tribal government official upon request of the official for the purpose of administration or enforcement of a law; and (6) shall be disclosed upon request— (A) to a health or environmental professional employed by a Federal or State agency in response to an environmental release; or (B) to a treating physician or other health care professional to assist in the diagnosis or treatment of one or more individuals. ; (2) in subsection (b)(1), in the matter following subparagraph (B)— (A) by striking data which discloses and inserting data that disclose formulas (including molecular structures) of a chemical substance or mixture, ; (B) by striking mixture or, and inserting mixture, or, ; and (C) by striking the release of data disclosing ; (3) in subsection (c)— (A) by striking the subsection heading and inserting Designating and substantiating confidentiality.— ; (B) by amending paragraph (1) to read as follows: (1) (A) In submitting information under this Act after date of enactment of the TSCA Modernization Act of 2015 , a manufacturer, processor, or distributor in commerce shall designate the information which such person believes is entitled to protection under this section, and submit such designated information separately from other information submitted under this Act. A designation under this subparagraph shall be made in writing and in such manner as the Administrator may prescribe, and shall include— (i) justification for each designation of confidentiality; (ii) a certification that the information is not otherwise publicly available; and (iii) separate copies of all submitted information, with one copy containing and one copy excluding the information to which the request applies. (B) Designations made under subparagraph (A) after the date of enactment of the TSCA Modernization Act of 2015 shall expire after 10 years, at which time the information shall be made public unless the manufacturer, processor, or distributor in commerce has reasserted the claim for protection, in writing and in such manner as the Administrator may prescribe, including all of the elements required for the initial submission. (C) Not later than 60 days prior to making information public under subparagraph (B), the Administrator shall notify, as appropriate and practicable, the manufacturer, processor, or distributor in commerce who designated the information under subparagraph (A) of the date on which such information will be made public unless a request for renewal is granted under subparagraph (B). ; and (C) in paragraph (2)— (i) in subparagraph (A), by inserting , for a reason other than the expiration of such designation pursuant to paragraph (1)(B), before proposes to release ; and (ii) in subparagraph (B)(i), by striking or (4) and inserting (4), or (6) ; and (4) by adding at the end the following new subsections: (f) Prohibition No person who receives information as permitted under subsection (a) may use such information for any purpose not specified in such subsection, nor disclose such information to any person not authorized to receive such information. (g) Savings Nothing in this section shall be construed to affect the applicability of State or Federal rules of evidence or procedure in any judicial proceeding. . 7. Effect on State law (a) In general Section 18(a) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a) ) is amended— (1) in paragraph (2)(A), by striking ; and and inserting a semicolon; (2) by striking paragraph (2)(B) and inserting the following: (B) if the Administrator makes a final determination under section 6(b) that a chemical substance will not present an unreasonable risk of injury to health or the environment under the intended condition of use, no State or political subdivision may, after the date of publication of such determination, establish or continue in effect any requirement that applies to such chemical substance under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b), and is designed to protect against exposure to such chemical substance under the intended conditions of use, unless the requirement of the State or political subdivision— (i) is adopted under the authority of a Federal law; or (ii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement; and (C) if the Administrator imposes a requirement, through a rule or order under section 5 or 6, that applies to a chemical substance or mixture (other than a requirement described in section 6(a)(6)) and is designed to protect against a risk of injury to health or the environment associated with such chemical substance or mixture, no State or political subdivision may, after the effective date of such requirement, establish or continue in effect any requirement that applies to such chemical substance or mixture (including a requirement that applies to an article because the article contains the chemical substance or mixture) and is designed to protect against exposure to the chemical substance or mixture either under the intended conditions of use considered by the Administrator in the risk evaluation under section 6(b) or from a use identified in a notice received by the Administrator under section 5(a), or, in the case of a requirement imposed pursuant to section 6(i), is designed to protect against a risk of injury considered by the Administrator in imposing such requirement, unless the requirement of the State or political subdivision— (i) is identical to the requirement imposed by the Administrator; (ii) is adopted under the authority of a Federal law; or (iii) is adopted to protect air or water quality or is related to waste treatment or waste disposal, except that this clause does not apply to such a requirement if a provision of this title, or an action or determination made by the Administrator under this title, actually conflicts with the requirement. ; and (3) by adding at the end the following: (3) In the case of an identical requirement described in paragraph (2)(C)(i)— (A) a State may not assess a penalty for a specific violation for which the Administrator has assessed a penalty under section 16; and (B) if a State has assessed a penalty for a specific violation, the Administrator 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 Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16. . (b) Savings Section 18 of the Toxic Substances Control Act ( 15 U.S.C. 2617 ) is amended by adding at the end the following: (c) Savings (1) Prior State actions Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken or requirement that has taken effect— (A) before August 1, 2015, under the authority of a State law that prohibits or otherwise restricts the manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or (B) pursuant to a State law that was in effect on August 31, 2003, unless an action or determination made by the Administrator under this title actually conflicts with the action taken or requirement that has taken effect pursuant to such a State law. (2) Tort and contract law Nothing in this title, nor any risk evaluation, rule, order, standard, or requirement completed or implemented under this title, shall be construed to preempt or otherwise affect either Federal or State tort law or the law governing the interpretation of contracts of any State, including any remedy for civil relief, whether under statutory or common law, including a remedy for civil damages, and any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory relating to tort law. (3) Intent of Congress It is not the intent of Congress that this title, or rules, regulations, or orders issued pursuant to this title, be interpreted as influencing, in either a plaintiff’s or defendant’s favor, the disposition of any civil action for damages in a State court, or the authority of any court to make a determination in an adjudicatory proceeding under applicable State law with respect to the admissibility of evidence, unless a provision of this title actually conflicts with the State court action. (4) Application For purposes of this title, the term requirements does not include civil tort actions for damages under State law. . (c) Effect of actions by Administrator Nothing in this Act, or the amendments made by this Act, shall be construed as changing the preemptive effect of an action taken by the Administrator prior to the date of enactment of this Act or under section 6(e). 8. Administration of the Act Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) in subsection (b)(1)— (A) by striking of a reasonable fee ; (B) by inserting of a fee that is sufficient and not more than reasonably necessary after section 4 or 5 ; (C) by inserting , or who requests a risk evaluation under section 6(b)(3)(A)(ii), before to defray the cost ; (D) by striking this Act and inserting the provision of this title for which such fee is collected ; and (E) by striking Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. and inserting Such rules shall provide for lower fees for small business concerns. ; (2) by adding at the end of subsection (b) the following: (3) Fund (A) Establishment There is established in the Treasury of the United States a revolving fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the Fund ), consisting of such amounts as are deposited in the Fund under this paragraph. (B) Collection and deposit of fees The Administrator shall collect the fees described in paragraph (1) and deposit those fees in the Fund. (C) Crediting and availability of fees On request by the Administrator, the Secretary of the Treasury shall transfer from the Fund to the Administrator amounts appropriated to pay or recover the full costs incurred by the Environmental Protection Agency, including contractor costs, in carrying out the provisions of this title for which the fees are collected under paragraph (1). (D) Use of funds by Administrator Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation for use only in administering the provisions of this title for which the fees are collected. (E) Accounting and auditing (i) Accounting The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code. (ii) Auditing (I) In general For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency. (II) Components of audit The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of— (aa) the fees collected and amounts disbursed under this subsection; (bb) the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of the title for which the fees are collected; and (cc) the number of requests for a risk evaluation made by manufacturers under section 6(b)(3)(A)(ii). (III) Federal responsibility The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit. ; and (3) by adding at the end the following: (h) Scientific standards In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall consider, as applicable— (1) the extent to which the scientific and technical procedures, measures, methods, or models employed to generate the information are reasonable for and consistent with the use of the information; (2) the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, or models, are evaluated and characterized; and (5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, or models. (i) Weight of scientific evidence The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence. (j) Availability of information Subject to section 14, the Administrator shall make available to the public all notices, determinations, findings, rules, and orders of the Administrator under this title. (k) Policies, procedures, and guidance (1) Development Not later than 2 years after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the TSCA Modernization Act of 2015 . (2) Review Not later than 5 years after the date of enactment of the TSCA Modernization Act of 2015 , and not less frequently than once every 5 years thereafter, the Administrator shall— (A) review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and (B) revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings. (l) Report to Congress (1) Initial report Not later than 6 months after the date of enactment of the TSCA Modernization Act of 2015 , the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of— (A) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under subparagraphs (A)(i) and (B) of section 6(b)(3), and the resources necessary to initiate the minimum number of risk evaluations required under section 6(b)(7); (B) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(3)(A)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand; (C) the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and (D) the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b). (2) Subsequent reports The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years. . 9. Conforming amendments (a) Section 4 Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (b)— (A) in paragraph (1), by striking rule each place it appears and inserting rule, order, or consent agreement ; (B) in paragraph (2)(B), by striking rules and inserting rules, orders, and consent agreements ; (C) in paragraph (3), by striking rule each place it appears and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule under subsection (a) each place it appears and inserting rule, order, or consent agreement under subsection (a) ; (ii) by striking repeals the rule each place it appears and inserting repeals the rule or order or modifies the consent agreement to terminate the requirement ; and (iii) by striking repeals the application of the rule and inserting repeals or modifies the application of the rule, order, or consent agreement ; (2) in subsection (c)— (A) in paragraph (1), by striking rule and inserting rule or order ; (B) in paragraph (2)— (i) in subparagraph (A), by striking a rule under subsection (a) or for which data is being developed pursuant to such a rule and inserting a rule, order, or consent agreement under subsection (a) or for which data are being developed pursuant to such a rule, order, or consent agreement ; (ii) in subparagraph (B), by striking such rule or which is being developed pursuant to such rule and inserting such rule, order, or consent agreement or which is being developed pursuant to such rule, order, or consent agreement ; and (iii) in the matter following subparagraph (B), by striking the rule and inserting the rule or order ; (C) in paragraph (3)(B)(i), by striking rule promulgated and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule promulgated each place it appears and inserting rule, order, or consent agreement ; (ii) by striking such rule each place it appears and inserting such rule, order, or consent agreement ; and (iii) in subparagraph (B), by striking the rule and inserting the rule, order, or consent agreement ; (3) in subsection (d), by striking rule and inserting rule, order, or consent agreement ; and (4) in subsection (g), by striking rule and inserting rule, order, or consent agreement . (b) Section 5 Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) in subsection (b)— (A) in paragraph (1)(A)— (i) by striking rule promulgated and inserting rule, order, or consent agreement ; and (ii) by striking such rule and inserting such rule, order, or consent agreement ; (B) in paragraph (1)(B)— (i) by striking rule promulgated and inserting rule or order ; and (ii) by striking the date of the submission in accordance with such rule and inserting the required date of submission ; and (C) in paragraph (2)(A)(ii), by striking rule promulgated and inserting rule, order, or consent agreement ; (2) in subsection (d)(2)(C), by striking rule and inserting rule, order, or consent agreement ; and (3) in subsection (h)(4), by striking paragraphs (2) and (3) of section 6(c) and inserting paragraph (2) of section 6(c) . (c) Section 6 Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— (1) in subsection (d)(2)(B)— (A) by striking , provide reasonable opportunity, in accordance with paragraphs (2) and (3) of subsection (c), for a hearing on such rule, and inserting in accordance with paragraph (2) of subsection (c), ; and (B) by striking ; and if such a hearing is requested and all that follows through or revoke it. and inserting a period; and (2) in subsection (e)(4), by striking paragraphs (2), (3), and (4) of subsection (c) and inserting paragraph (2) of subsection (c) . (d) Section 7 Section 7(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2606(a)(1) ) is amended, in the matter following subparagraph (C), by striking a rule under section 4, 5, 6, or title IV or an order under section 5 or title IV and inserting a rule under section 4, 5, or 6 or title IV, an order under section 4 or 5 or title IV, or a consent agreement under section 4 . (e) Section 8 Section 8(a)(3)(A)(ii)(I) of the Toxic Substances Control Act ( 15 U.S.C. 2607(a)(3)(A)(ii)(I) ) is amended by striking or an order in effect under section 5(e) and inserting , an order in effect under section 4 or 5(e), or a consent agreement under section 4 . (f) Section 9 Section 9(a) of the Toxic Substances Control Act ( 15 U.S.C. 2608(a) ) is amended by striking section 6 each place it appears and inserting section 6(a) . (g) Section 11 Section 11(b)(2)(E) of the Toxic Substances Control Act ( 15 U.S.C. 2610(b)(2)(E) ) is amended by striking rule promulgated and inserting rule promulgated, order issued, or consent agreement entered into . (h) Section 15 Section 15(1) of the Toxic Substances Control Act ( 15 U.S.C. 2614(1) ) is amended by striking (A) any rule and all that follows through or (D) and inserting any requirement of this title or any rule promulgated, order issued, or consent agreement entered into under this title, or . (i) Section 18 Section 18(a)(2)(A) of the Toxic Substances Control Act ( 15 U.S.C. 2617(a)(2)(A) ) is amended— (1) by striking rule promulgated and inserting rule, order, or consent agreement ; and (2) by striking such rule each place it appears and inserting such rule, order, or consent agreement . (j) Section 19 Section 19 of the Toxic Substances Control Act ( 15 U.S.C. 2618 ) is amended— (1) in subsection (a)— (A) in paragraph (1)(A)— (i) by striking (A) Not later than 60 days after the date of the promulgation of a rule and inserting Not later than 60 days after the date on which a rule is promulgated ; (ii) by inserting or the date on which an order is issued under section 4, before any person ; (iii) by striking such rule and inserting such rule or order ; and (iv) by striking such a rule and inserting such a rule or order ; (B) by striking paragraph (1)(B); (C) in paragraph (2), by striking the rule and inserting the rule or order ; and (D) in paragraph (3)— (i) in subparagraph (A), by striking the rule and inserting the rule or order ; (ii) in subparagraph (B), by striking a rule under section 4(a) and inserting a rule or order under section 4(a) ; (iii) in subparagraph (C), by striking such rule and inserting such rule or order ; (iv) in subparagraph (D), by striking such rule and inserting such rule or order ; and (v) in subparagraph (E)— (I) by striking to such rule and inserting to such rule or order ; and (II) by striking the date of the promulgation of such rule and inserting the date on which such rule is promulgated or such order is issued ; (2) in subsection (b)— (A) by striking review a rule and inserting review a rule, or an order under section 4, ; (B) by striking such rule and inserting such rule or order ; (C) by striking the rule and inserting the rule or order ; (D) by striking new rule each place it appears and inserting new rule or order ; and (E) by striking modified rule and inserting modified rule or order ; and (3) in subsection (c)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking a rule and inserting a rule, or an order under section 4 ; and (II) by striking such rule and inserting such rule or order ; and (ii) in subparagraph (B)— (I) in the matter preceding clause (i), by striking a rule and inserting a rule or order ; (II) in clause (i)— (aa) by inserting or an order under section 4, before the standard for review ; (bb) by striking such rule and inserting such rule or order ; (cc) by striking the rule and inserting the rule or order ; and (dd) by striking the semicolon and inserting ; and ; and (III) by striking clause (ii) and redesignating clause (iii) as clause (ii); and (B) in paragraph (2), by striking any rule and inserting any rule or order . (k) Section 20 Section 20(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2619(a)(1) ) is amended by striking order issued under section 5 and inserting order issued under section 4 or 5 . (l) Section 21 Section 21 of the Toxic Substances Control Act ( 15 U.S.C. 2620 ) is amended— (1) in subsection (a), by striking order under section 5(e) or (6)(b)(2) and inserting order under section 4 or 5(e) ; and (2) in subsection (b)— (A) in paragraph (1), by striking order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B) and inserting order under section 4 or 5(e) ; and (B) in paragraph (4)(B)— (i) in the matter preceding clause (i), by striking order under section 5(e) or 6(b)(2) and inserting order under section 4 or 5(e) ; (ii) in clause (i), by striking order under section 5(e) and inserting order under section 4 or 5(e) ; and (iii) in clause (ii), by striking or an order under section 6(b)(2) . (m) Section 24 Section 24(b)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2623(b)(2)(B) ) is amended— (1) by inserting and at the end of clause (i); (2) by striking clause (ii); and (3) by redesignating clause (iii) as clause (ii). (n) Section 27 Section 27(a) of the Toxic Substances Control Act ( 15 U.S.C. 2626(a) ) is amended by striking rules promulgated and inserting rules, orders, or consent agreements . (o) Section 30 Section 30(2) of the Toxic Substances Control Act ( 15 U.S.C. 2629(2) ) is amended by striking rule and inserting rule, order, or consent agreement .

Passed the House of Representatives June 23, 2015. Karen L. Haas, Clerk

July 8, 2015 Read twice and placed on the calendar

tv_txt: 114th CONGRESS 1st Session H.R. 2576 In the Senate of the United States, December 17, 2015. Amendment:

That the bill from the House of Representatives (H.R. 2576) entitled An Act to modernize the Toxic Substances Control Act, and for other purposes. , do pass with the following Strike all after the enacting clause and insert the following: 1. Short title This Act may be cited as the Frank R. Lautenberg Chemical Safety for the 21st Century Act . 2. Findings, policy, and intent Section 2(c) of the Toxic Substances Control Act ( 15 U.S.C. 2601(c) ) is amended— (1) by striking It is the intent and inserting the following: (1) Administration It is the intent ; (2) in paragraph (1) (as so redesignated), by inserting , as provided under this Act before the period at the end; and (3) by adding at the end the following: (2) Reform This Act, including reforms in accordance with the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act — (A) shall be administered in a manner that— (i) 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 (ii) ensures that appropriate information on chemical substances and mixtures is available to public health officials and first responders in the event of an emergency; and (B) shall not displace or supplant common law rights of action or remedies for civil relief. . 3. Definitions Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) by redesignating paragraphs (4), (5), (6), (7), (8), (9), (10), (11), (12), (13), and (14) as paragraphs (5), (6), (7), (8), (9), (10), (12), (13), (17), (18), and (19), respectively; (2) by inserting after paragraph (3) the following: (4) Conditions of use The term conditions of use means the intended, known, or reasonably foreseeable circumstances the Administrator determines a chemical substance is manufactured, processed, distributed in commerce, used, or disposed of. ; (3) by inserting after paragraph (10) (as so redesignated) the following: (11) Potentially exposed or susceptible population The term potentially exposed or susceptible population means 1 or more groups— (A) of individuals within the general population who may be— (i) differentially exposed to chemical substances under the conditions of use; or (ii) susceptible to greater adverse health consequences from chemical exposures than the general population; and (B) that when identified by the Administrator may include such groups as infants, children, pregnant women, workers, and the elderly. ; and (4) by inserting after paragraph (13) (as so redesignated) the following: (14) Safety assessment The term safety assessment means an assessment of the risk posed by a chemical substance under the conditions of use, integrating hazard, use, and exposure information regarding the chemical substance. (15) Safety determination The term safety determination means a determination by the Administrator as to whether a chemical substance meets the safety standard under the conditions of use. (16) Safety standard The term safety standard means a standard that ensures, without taking into consideration cost or other nonrisk factors, that no unreasonable risk of injury to health or the environment will result from exposure to a chemical substance under the conditions of use, including no unreasonable risk of injury to— (A) the general population; or (B) any potentially exposed or susceptible population that the Administrator has identified as relevant to the safety assessment and safety determination for a chemical substance. . 4. Policies, procedures, and guidance The Toxic Substances Control Act is amended by inserting after section 3 ( 15 U.S.C. 2602 ) the following: 3A. Policies, procedures, and guidance (a) Definition of guidance In this section, the term guidance includes any significant written guidance of general applicability prepared by the Administrator. (b) Deadline Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall develop, after providing public notice and an opportunity for comment, any policies, procedures, and guidance the Administrator determines to be necessary to carry out sections 4, 4A, 5, and 6, including the policies, procedures, and guidance required by this section. (c) Use of science (1) In general The Administrator shall establish policies, procedures, and guidance on the use of science in making decisions under sections 4, 4A, 5, and 6. (2) Goal A goal of the policies, procedures, and guidance described in paragraph (1) shall be to make the basis of decisions clear to the public. (3) Requirements The policies, procedures, and guidance issued under this section shall ensure that— (A) decisions made by the Administrator— (i) are based on information, procedures, measures, methods, and models employed in a manner consistent with the best available science; (ii) take into account the extent to which— (I) assumptions and methods are clearly and completely described and documented; (II) variability and uncertainty are evaluated and characterized; and (III) the information has been subject to independent verification and peer review; and (iii) are based on the weight of the scientific evidence, by which the Administrator considers all information in a systematic and integrative framework to consider the relevance of different information; (B) to the extent practicable and if appropriate, the use of peer review, standardized test design and methods, consistent data evaluation procedures, and good laboratory practices will be encouraged; (C) a clear description of each individual and entity that funded the generation or assessment of information, and the degree of control those individuals and entities had over the generation, assessment, and dissemination of information (including control over the design of the work and the publication of information) is made available; and (D) if appropriate, the recommendations in reports of the National Academy of Sciences that provide advice regarding assessing the hazards, exposures, and risks of chemical substances are considered. (d) Existing EPA policies, procedures, and guidance The policies, procedures, and guidance described in subsection (b) shall incorporate existing relevant policies, procedures, and guidance, as appropriate and consistent with this Act. (e) Review Not later than 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and not less frequently than once every 5 years thereafter, the Administrator shall— (1) review the adequacy of any policies, procedures, and guidance developed under this section, including animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this Act; and (2) after providing public notice and an opportunity for comment, revise the policies, procedures, and guidance if necessary to reflect new scientific developments or understandings. (f) Sources of information In carrying out sections 4, 4A, 5, and 6, the Administrator shall take into consideration information relating to a chemical substance, including hazard and exposure information, under the conditions of use that is reasonably available to the Administrator, including information that is— (1) submitted to the Administrator pursuant to any rule, consent agreement, order, or other requirement of this Act, or on a voluntary basis, including pursuant to any request made under this Act, by— (A) manufacturers or processors of a substance; (B) the public; (C) other Federal departments or agencies; or (D) the Governor of a State or a State agency with responsibility for protecting health or the environment; (2) submitted to a governmental entity in any jurisdiction pursuant to a governmental requirement relating to the protection of health or the environment; or (3) identified through an active search by the Administrator of information sources that are publicly available or otherwise accessible by the Administrator. (g) Testing of chemical substances and mixtures (1) In general The Administrator shall establish policies, procedures, and guidance for the testing of chemical substances or mixtures under section 4. (2) Goal A goal of the policies, procedures, and guidance established under paragraph (1) shall be to make the basis of decisions clear to the public. (3) Contents The policies, procedures, and guidance established under paragraph (1) shall— (A) address how and when the exposure level or exposure potential of a chemical substance would factor into decisions to require new testing, subject to the condition that the Administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential; and (B) describe the manner in which the Administrator will determine that additional information is necessary to carry out this Act, including information relating to potentially exposed or susceptible populations. (4) Epidemiological studies Before prescribing epidemiological studies of employees, the Administrator shall consult with the Director of the National Institute for Occupational Safety and Health. (h) Safety assessments and safety determinations (1) Schedule (A) In general The Administrator shall inform the public regarding the schedule and the resources necessary for the completion of each safety assessment and safety determination as soon as practicable after designation as a high-priority substance pursuant to section 4A. (B) Differing times The Administrator may allot different times for different chemical substances in the schedules under this paragraph, subject to the condition that all schedules shall comply with the deadlines established under section 6. (C) Annual plan (i) In general At the beginning of each calendar year, the Administrator shall publish an annual plan. (ii) Inclusions The annual plan shall— (I) identify the substances subject to safety assessments and safety determinations to be completed that year; (II) describe the status of each safety assessment and safety determination that has been initiated but not yet completed, including milestones achieved since the previous annual report; and (III) if the schedule for completion of a safety assessment and safety determination prepared pursuant to subparagraph (A) has changed, include an updated schedule for that safety assessment and safety determination. (2) Policies and procedures for safety assessments and safety determinations (A) In general The Administrator shall establish, by rule, policies and procedures regarding the manner in which the Administrator shall carry out section 6. (B) Goal A goal of the policies and procedures under this paragraph shall be to make the basis of decisions of the Administrator clear to the public. (C) Minimum requirements The policies and procedures under this paragraph shall, at a minimum— (i) describe— (I) the manner in which the Administrator will identify informational needs and seek that information from the public; (II) the information (including draft safety assessments) that may be submitted by interested individuals or entities, including States; and (III) the criteria by which information submitted by interested individuals or entities will be evaluated; (ii) require that each draft and final safety assessment and safety determination of the Administrator include a description of— (I) (aa) the scope of the safety assessment and safety determination to be conducted under section 6, including the hazards, exposures, and conditions of use of the chemical substance, and potentially exposed and susceptible populations that the Administrator has identified as relevant; and (bb) the basis for the scope of the safety assessment and safety determination; (II) the manner in which aggregate exposures, or significant subsets of exposures, to a chemical substance under the conditions of use were considered, and the basis for that consideration; (III) the weight of the scientific evidence of risk; and (IV) the information regarding the impact on health and the environment of the chemical substance that was used to make the assessment or determination, including, as available, mechanistic, animal toxicity, and epidemiology studies; (iii) establish a timely and transparent process for evaluating whether new information submitted or obtained after the date of a final safety assessment or safety determination warrants reconsideration of the safety assessment or safety determination; and (iv) when relevant information is provided or otherwise made available to the Administrator, require the Administrator to consider the extent of Federal regulation under other Federal laws. (D) Guidance (i) In general Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall develop guidance to assist interested persons in developing their own draft safety assessments and other information for submission to the Administrator, which may be considered by the Administrator. (ii) Requirement The guidance shall, at a minimum, address the quality of the information submitted and the process to be followed in developing a draft safety assessment for consideration by the Administrator. (i) Publicly available information Subject to section 14, the Administrator shall— (1) make publicly available a nontechnical summary, and the final version, of each safety assessment and safety determination; (2) provide public notice and an opportunity for comment on each proposed safety assessment and safety determination; and (3) make public in a final safety assessment and safety determination— (A) the list of studies considered by the Administrator in carrying out the safety assessment or safety determination; and (B) the list of policies, procedures, and guidance that were followed in carrying out the safety assessment or safety determination. (j) Consultation with Science Advisory Committee on Chemicals (1) Establishment Not later than 1 year after the date of enactment of this section, the Administrator shall establish an advisory committee, to be known as the Science Advisory Committee on Chemicals (referred to in this subsection as the Committee ). (2) Purpose The purpose of the Committee shall be to provide independent advice and expert consultation, on the request of the Administrator, with respect to the scientific and technical aspects of issues relating to the implementation of this title. (3) Composition The Committee shall be composed of representatives of such science, government, labor, public health, public interest, animal protection, industry, and other groups as the Administrator determines to be advisable, including, at a minimum, representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible populations. (4) Schedule The Administrator shall convene the Committee in accordance with such schedule as the Administrator determines to be appropriate, but not less frequently than once every 2 years. (5) Relationship to other law All proceedings and meetings of the Committee shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.). . 5. Testing of chemical substances or mixtures (a) In general Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) by striking subsections (a), (b), (c), (d), (e), and (g); (2) in subsection (f)— (A) in the first sentence— (i) by striking from cancer, gene mutations, or birth defects ; and (ii) by inserting , without taking into account cost or other nonrisk factors before the period at the end; and (B) by striking the last sentence; and (3) by inserting before subsection (f) the following: (a) Development of new information on chemical substances and mixtures (1) In general The Administrator may require the development of new information relating to a chemical substance or mixture in accordance with this section if the Administrator determines that the information is necessary— (A) to review a notice under section 5(d) or to perform a safety assessment or safety determination under section 6; (B) to implement a requirement imposed in a consent agreement or order issued under section 5(d)(4) or under a rule promulgated under section 6(d)(3); (C) pursuant to section 12(a)(4); or (D) at the request of the implementing authority under another Federal law, to meet the regulatory testing needs of that authority. (2) Limited testing for prioritization purposes (A) In general Except as provided in subparagraph (B), the Administrator may require the development of new information for the purposes of section 4A. (B) Prohibition Testing required under subparagraph (A) shall not be required for the purpose of establishing or implementing a minimum information requirement. (C) Limitation The Administrator may require the development of new information pursuant to subparagraph (A) only if the Administrator determines that additional information is necessary to establish the priority of a chemical substance. (3) Form The Administrator may require the development of information described in paragraph (1) or (2) by— (A) promulgating a rule; (B) entering into a testing consent agreement; or (C) issuing an order. (4) Contents (A) In general A rule, testing consent agreement, or order issued under this subsection shall include— (i) identification of the chemical substance or mixture for which testing is required; (ii) identification of the persons required to conduct the testing; (iii) test protocols and methodologies for the development of information for the chemical substance or mixture, including specific reference to any reliable nonanimal test procedures; and (iv) specification of the period within which individuals and entities required to conduct the testing shall submit to the Administrator the information developed in accordance with the procedures described in clause (iii). (B) Considerations In determining the procedures and period to be required under subparagraph (A), the Administrator shall take into consideration— (i) the relative costs of the various test protocols and methodologies that may be required; (ii) the reasonably foreseeable availability of facilities and personnel required to perform the testing; and (iii) the deadlines applicable to the Administrator under section 6(a). (5) Consideration of Federal agency recommendations The Administrator shall consider the recommendations of other Federal agencies regarding the chemical substances and mixtures to which the Administrator shall give priority consideration under this section. (b) Statement of need (1) In general In promulgating a rule, entering into a testing consent agreement, or issuing an order for the development of additional information (including information on exposure or exposure potential) pursuant to this section, the Administrator shall— (A) identify the need intended to be met by the rule, agreement, or order; (B) explain why information reasonably available to the Administrator at that time is inadequate to meet that need, including a reference, as appropriate, to the information identified in paragraph (2)(B); and (C) explain the basis for any decision that requires the use of vertebrate animals. (2) Explanation in case of order (A) In general If the Administrator issues an order under this section, the Administrator shall issue a statement providing a justification for why issuance of an order is warranted instead of promulgating a rule or entering into a testing consent agreement. (B) Contents A statement described in subparagraph (A) shall contain a description of— (i) information that is readily accessible to the Administrator, including information submitted under any other provision of law; (ii) the extent to which the Administrator has obtained or attempted to obtain the information through voluntary submissions; and (iii) any information relied on in safety assessments for other chemical substances relevant to the chemical substances that would be the subject of the order. (c) Reduction of testing on vertebrates (1) In general The Administrator shall minimize, to the extent practicable, the use of vertebrate animals in testing of chemical substances or mixtures, by— (A) prior to making a request or adopting a requirement for testing using vertebrate animals, taking into consideration, as appropriate and to the extent practicable, reasonably available— (i) toxicity information; (ii) computational toxicology and bioinformatics; (iii) high-throughput screening methods and the prediction models of those methods; and (iv) scientifically reliable and relevant alternatives to tests on animals that would provide equivalent information; (B) encouraging and facilitating— (i) the use of integrated and tiered testing and assessment strategies; (ii) the use of best available science in existence on the date on which the test is conducted; (iii) the use of test methods that eliminate or reduce the use of animals while providing information of high scientific quality; (iv) the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide reliable and useful information on other chemical substances in the category; (v) the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests; and (vi) the submission of information from— (I) animal-based studies; and (II) emerging methods and models; and (C) funding research and validation studies to reduce, refine, and replace the use of animal tests in accordance with this subsection. (2) Implementation of alternative testing methods To promote the development and timely incorporation of new testing methods that are not based on vertebrate animals, the Administrator shall— (A) not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , develop a strategic plan to promote the development and implementation of alternative test methods and testing strategies to generate information under this title that can reduce, refine, or replace the use of vertebrate animals, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening; (B) as practicable, ensure that the strategic plan developed under subparagraph (A) is reflected in the development of requirements for testing under this section; (C) identify in the strategic plan developed under subparagraph (A) particular alternative test methods or testing strategies that do not require new vertebrate animal testing and are scientifically reliable, relevant, and capable of providing information of equivalent scientific reliability and quality to that which would be obtained from vertebrate animal testing; (D) provide an opportunity for public notice and comment on the contents of the plan developed under subparagraph (A), including the criteria for considering scientific reliability, relevance, and equivalent information and the test methods and strategies identified in subparagraph (C); (E) beginning on the date that is 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act and every 5 years thereafter, submit to Congress a report that describes the progress made in implementing this subsection and goals for future alternative test methods implementation; (F) fund and carry out research, development, performance assessment, and translational studies to accelerate the development of test methods and testing strategies that reduce, refine, or replace the use of vertebrate animals in any testing under this title; and (G) identify synergies with the related information requirements of other jurisdictions to minimize the potential for additional or duplicative testing. (3) Criteria for adapting or waiving animal testing requirements On request from a manufacturer or processor that is required to conduct testing of a chemical substance or mixture on vertebrate animals under this section, the Administrator may adapt or waive the requirement, if the Administrator determines that— (A) there is sufficient evidence from several independent sources of information to support a conclusion that a chemical substance or mixture has, or does not have, a particular property if the information from each individual source alone is insufficient to support the conclusion; (B) as a result of 1 or more physical or chemical properties of the chemical substance or mixture or other toxicokinetic considerations— (i) the substance cannot be absorbed; or (ii) testing for a specific endpoint is technically not practicable to conduct; or (C) a chemical substance or mixture cannot be tested in vertebrate animals at concentrations that do not result in significant pain or distress, because of physical or chemical properties of the chemical substance or mixture, such as a potential to cause severe corrosion or severe irritation to the tissues of the animal. (4) Voluntary testing (A) In general Any person developing information for submission under this title on a voluntary basis and not pursuant to any request or requirement by the Administrator shall first attempt to develop the information by means of an alternative or nonanimal test method or testing strategy that the Administrator has determined under paragraph (2)(C) to be scientifically reliable, relevant, and capable of providing equivalent information, before conducting new animal testing. (B) Effect of paragraph Nothing in this paragraph— (i) requires the Administrator to review the basis on which the person is conducting testing described in subparagraph (A); (ii) prohibits the use of other test methods or testing strategies by any person for purposes other than developing information for submission under this title on a voluntary basis; or (iii) prohibits the use of other test methods or testing strategies by any person, subsequent to the attempt to develop information using the test methods and testing strategies identified by the Administrator under paragraph (2)(C). (d) Testing requirements (1) In general The Administrator may require the development of information by— (A) manufacturers and processors of the chemical substance or mixture; and (B) persons that begin to manufacture or process the chemical substance or mixture after the effective date of the rule, testing consent agreement, or order. (2) Designation The Administrator may permit 2 or more persons identified in subparagraph (A) or (B) of paragraph (1) to designate 1 of the persons or a qualified third party— (A) to develop the information; and (B) to submit the information on behalf of the persons making the designation. (3) Exemptions (A) In general A person otherwise subject to a rule, testing consent agreement, or order under this section may submit to the Administrator an application for an exemption on the basis that submission of information by the applicant on the chemical substance or mixture would be duplicative of— (i) information on the chemical substance or mixture that— (I) has been submitted to the Administrator pursuant to a rule, consent agreement, or order under this section; or (II) is being developed by a person designated under paragraph (2); or (ii) information on an equivalent chemical substance or mixture that— (I) has been submitted to the Administrator pursuant to a rule, consent agreement, or order under this section; or (II) is being developed by a person designated under paragraph (2). (B) Fair and equitable reimbursement to designee (i) In general If the Administrator accepts an application submitted under subparagraph (A), before the end of the reimbursement period described in clause (iii), the Administrator shall direct the applicant to provide to the person designated under paragraph (2) fair and equitable reimbursement, as agreed to between the applicant and the designee. (ii) Arbitration If the applicant and a person designated under paragraph (2) cannot reach agreement on the amount of fair and equitable reimbursement, the amount shall be determined by arbitration. (iii) Reimbursement period For the purposes of this subparagraph, the reimbursement period for any information for a chemical substance or mixture is a period— (I) beginning on the date the information is submitted in accordance with a rule, testing consent agreement, or order under this section; and (II) ending on the later of— (aa) 5 years after the date referred to in subclause (I); or (bb) the last day of the period that begins on the date referred to in subclause (I) and that is equal to the period that the Administrator determines was necessary to develop the information. (C) Termination If, after granting an exemption under this paragraph, the Administrator determines that no person designated under paragraph (2) has complied with the rule, testing consent agreement, or order, the Administrator shall— (i) by order, terminate the exemption; and (ii) notify in writing each person that received an exemption of the requirements with respect to which the exemption was granted. (4) Tiered testing (A) In general Except as provided in subparagraph (D), the Administrator shall employ a tiered screening and testing process, under which the results of screening-level tests or assessments of available information inform the decision as to whether 1 or more additional tests are necessary. (B) Screening-level tests (i) In general The screening-level tests required for a chemical substance or mixture may include tests for hazard (which may include in silico, in vitro, and in vivo tests), environmental and biological fate and transport, and measurements or modeling of exposure or exposure potential, as appropriate. (ii) Use Screening-level tests shall be used— (I) to screen chemical substances or mixtures for potential adverse effects; and (II) to inform a decision of the Administrator regarding whether more complex or targeted additional testing is necessary. (C) Additional testing If the Administrator determines under subparagraph (B) that additional testing is necessary to provide more definitive information for safety assessments or safety determinations, the Administrator may require more advanced tests for potential health or environmental effects or exposure potential. (D) Advanced testing without screening The Administrator may require more advanced testing without conducting screening-level testing when other information available to the Administrator justifies the advanced testing, pursuant to guidance developed by the Administrator under this section. (e) Transparency Subject to section 14, the Administrator shall make available to the public all testing consent agreements and orders and all information submitted under this section. . (b) Conforming amendment Section 104(i)(5)(A) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 ( 42 U.S.C. 9604(i)(5)(A) ) is amended in the third sentence by inserting (as in effect on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ) after Toxic Substances Control Act . 6. Prioritization screening The Toxic Substances Control Act is amended by inserting after section 4 ( 15 U.S.C. 2603 ) the following: 4A. Prioritization screening (a) Prioritization screening process and list of substances (1) In general Not later than 1 year after the date of enactment of this section, the Administrator shall establish, by rule, a risk-based screening process and criteria for identifying existing chemical substances that are— (A) a high priority for a safety assessment and safety determination under section 6 (referred to in this Act as high-priority substances ); and (B) a low priority for a safety assessment and safety determination (referred to in this Act as low-priority substances ). (2) Initial and subsequent lists of high- and low-priority substances (A) In general Before the date of promulgation of the rule under paragraph (1) and not later than 180 days after the date of enactment of this section, the Administrator shall publish an initial list of high-priority substances and low-priority substances. (B) Requirements (i) In general The initial list of chemical substances shall contain at least 10 high-priority substances, at least 5 of which are drawn from the list of chemical substances identified by the Administrator in the October 2014 TSCA Work Plan and subsequent updates, and at least 10 low-priority substances. (ii) Subsequently identified substances Insofar as possible, at least 50 percent of all substances subsequently identified by the Administrator as high-priority substances shall be drawn from the list of chemical substances identified by the Administrator in the October 2014 TSCA Work Plan and subsequent updates, until all Work Plan chemicals have been designated under this subsection. (iii) Preferences (I) In general In developing the initial list and in identifying additional high-priority substances, the Administrator shall give preference to— (aa) chemical substances that, with respect to persistence and bioaccumulation, score high for 1 and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012; and (bb) chemical substances listed in the October 2014 TSCA Work Plan and subsequent updates that are known human carcinogens and have high acute and chronic toxicity. (II) Metals and metal compounds In prioritizing and assessing metals and metal compounds, the Administrator shall use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated March 2007 (or a successor document), and may use other applicable information consistent with the best available science. (C) Additional chemical reviews The Administrator shall, as soon as practicable and not later than— (i) 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , add additional high-priority substances sufficient to ensure that at least a total of 20 high-priority substances have undergone or are undergoing the process established in section 6(a), and additional low-priority substances sufficient to ensure that at least a total of 20 low-priority substances have been designated; and (ii) 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , add additional high-priority substances sufficient to ensure that at least a total of 25 high-priority substances have undergone or are undergoing the process established in section 6(a), and additional low-priority substances sufficient to ensure that at least a total of 25 low-priority substances have been designated. (3) Implementation (A) Consideration of active and inactive substances (i) Active substances In implementing the prioritization screening process established under paragraph (1), the Administrator shall take into consideration active substances, as determined under section 8, which may include chemical substances on the interim list of active substances established under that section. (ii) Inactive substances In implementing the prioritization screening process established under paragraph (1), the Administrator may take into consideration inactive substances, as determined under section 8, that the Administrator determines— (I) (aa) have not been subject to a regulatory or other enforceable action by the Administrator to ban or phase out the substances; and (bb) have the potential for high hazard and widespread exposure; or (II) (aa) have been subject to a regulatory or other enforceable action by the Administrator to ban or phase out the substances; and (bb) with respect to which there exists the potential for residual high hazards or widespread exposures not otherwise addressed by the regulatory or other action. (iii) Repopulation (I) In general On the completion of a safety determination under section 6 for a chemical substance, the Administrator shall remove the chemical substance from the list of high-priority substances established under this subsection. (II) Additions The Administrator shall add at least 1 chemical substance to the list of high-priority substances for each chemical substance removed from the list of high-priority substances established under this subsection, until a safety assessment and safety determination is completed for all chemical substances not designated as high-priority. (B) Timely completion of prioritization screening process (i) In general The Administrator shall— (I) except as provided under paragraph (2), not later than 180 days after the effective date of the final rule under paragraph (1), begin the prioritization screening process; and (II) make every effort to complete the designation of all active substances as high-priority substances or low-priority substances in a timely manner. (ii) Decisions on substances subject to testing for prioritization purposes Not later than 90 days after the date of receipt of information regarding a chemical substance complying with a rule, testing consent agreement, or order issued under section 4(a)(2), the Administrator shall designate the chemical substance as a high-priority substance or low-priority substance. (iii) Consideration (I) In general The Administrator shall screen substances and designate high-priority substances consistent with the ability of the Administrator to schedule and complete safety assessments and safety determinations under section 6 in accordance with the deadlines under subsection (a) of that section. (II) Annual goal The Administrator shall publish an annual goal for the number of chemical substances to be subject to the prioritization screening process. (C) Screening of categories of substances The Administrator may screen categories of chemical substances to ensure an efficient prioritization screening process to allow for timely and adequate designations of high-priority substances and low-priority substances and safety assessments and safety determinations for high-priority substances. (D) Publication of list of chemical substances The Administrator shall keep current and publish a list of chemical substances that includes and identifies substances— (i) that are being considered in the prioritization screening process and the status of the substances in the prioritization process; (ii) for which prioritization decisions have been postponed pursuant to subsection (b)(5), including the basis for the postponement; and (iii) that are designated as high-priority substances or low-priority substances, including the bases for such designations. (4) Criteria The criteria described in paragraph (1) shall account for— (A) the recommendation of the Governor of a State or a State agency with responsibility for protecting health or the environment from chemical substances appropriate for prioritization screening; (B) the hazard and exposure potential of the chemical substance (or category of substances), including persistence, bioaccumulation, and specific scientific classifications and designations by authoritative governmental entities; (C) the conditions of use or significant changes in the conditions of use of the chemical substance; (D) evidence and indicators of exposure potential to humans or the environment from the chemical substance, including potentially exposed or susceptible populations and storage near significant sources of drinking water; (E) the volume of a chemical substance manufactured or processed; (F) whether the volume of a chemical substance as reported pursuant to a rule promulgated pursuant to section 8(a) has significantly increased or decreased; (G) the availability of information regarding potential hazards and exposures required for conducting a safety assessment or safety determination, with limited availability of relevant information to be a sufficient basis for designating a chemical substance as a high-priority substance, subject to the condition that limited availability shall not require designation as a high-priority substance; and (H) the extent of Federal or State regulation of the chemical substance or the extent of the impact of State regulation of the chemical substance on the United States, with existing Federal or State regulation of any uses evaluated in the prioritization screening process as a factor in designating a chemical substance to be a high-priority or a low-priority substance. (b) Prioritization screening process and decisions (1) In general In implementing the prioritization screening process developed under subsection (a), the Administrator shall— (A) identify the chemical substances being considered for prioritization; (B) request interested persons to supply information regarding the chemical substances being considered; (C) apply the criteria identified in subsection (a)(4); and (D) subject to paragraph (5) and using the information available to the Administrator at the time of the decision, identify a chemical substance as a high-priority substance or a low-priority substance. (2) Reasonably available information The prioritization screening decision regarding a chemical substance shall consider any hazard and exposure information relating to the chemical substance that is reasonably available to the Administrator. (3) Identification of high-priority substances The Administrator— (A) shall identify as a high-priority substance a chemical substance that, relative to other active chemical substances, the Administrator determines has the potential for significant hazard and significant exposure; (B) may identify as a high-priority substance a chemical substance that, relative to other active chemical substances, the Administrator determines has the potential for significant hazard or significant exposure; and (C) may identify as a high-priority substance an inactive substance, as determined under subsection (a)(3)(A)(ii) and section 8(b), that the Administrator determines warrants a safety assessment and safety determination under section 6. (4) Identification of low-priority substances The Administrator shall identify as a low-priority substance a chemical substance that the Administrator concludes has information sufficient to establish that the chemical substance is likely to meet the safety standard. (5) Postponing a decision If the Administrator determines that additional information is needed to establish the priority of a chemical substance under this section, the Administrator may postpone a prioritization screening decision for a reasonable period— (A) to allow for the submission of additional information by an interested person and for the Administrator to evaluate the additional information; or (B) to require the development of information pursuant to a rule, testing consent agreement, or order issued under section 4(a)(2). (6) Deadlines for submission of information If the Administrator requests the development or submission of information under this section, the Administrator shall establish a deadline for submission of the information. (7) Notice and comment The Administrator shall— (A) publish, including in the Federal Register, the proposed decisions made under paragraphs (3), (4), and (5) and the basis for the decisions; (B) identify the information and analysis on which the decisions are based; and (C) provide 90 days for public comment. (8) Revisions of prior designations (A) In general At any time, the Administrator may revise the designation of a chemical substance as a high-priority substance or a low-priority substance based on information available to the Administrator after the date of the determination under paragraph (3) or (4). (B) Limited availability If limited availability of relevant information was a basis in the designation of a chemical substance as a high-priority substance, the Administrator shall reevaluate the prioritization screening of the chemical substance on receiving the relevant information. (9) Other information relevant to prioritization (A) In general If, after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , a State proposes an administrative action or enacts a statute or takes an administrative action to prohibit or otherwise restrict the manufacturing, processing, distribution in commerce, or use of a chemical substance that the Administrator has not designated as a high-priority substance, the Governor or State agency with responsibility for implementing the statute or administrative action shall notify the Administrator. (B) Requests for information Following receipt of a notification provided under subparagraph (A), the Administrator may request any available information from the Governor or the State agency with respect to— (i) scientific evidence related to the hazards, exposures and risks of the chemical substance under the conditions of use which the statute or administrative action is intended to address; (ii) any State or local conditions which warranted the statute or administrative action; (iii) the statutory or administrative authority on which the action is based; and (iv) any other available information relevant to the prohibition or other restriction, including information on any alternatives considered and their hazards, exposures, and risks. (C) Prioritization screening The Administrator shall conduct a prioritization screening under this subsection for all substances that— (i) are the subject of notifications received under subparagraph (A); and (ii) the Administrator determines— (I) are likely to have significant health or environmental impacts; (II) are likely to have significant impact on interstate commerce; or (III) have been subject to a prohibition or other restriction under a statute or administrative action in 2 or more States. (D) Post-Prioritization Notice If, after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , a State proposes or takes an administrative action or enacts a statute to prohibit or otherwise restrict the manufacturing, processing, distribution in commerce, or use of a high-priority substance, after the date on which the deadline established pursuant to subsection (a) of section 6 for completion of the safety determination under that subsection expires but before the date on which the Administrator publishes the safety determination under that subsection, the Governor or State agency with responsibility for implementing the statute or administrative action shall— (i) notify the Administrator; and (ii) provide the scientific and legal basis for the action. (E) Availability to public Subject to section 14 and any applicable State law regarding the protection of confidential information provided to the State or to the Administrator, the Administrator shall make information received from a Governor or State agency under subparagraph (A) publicly available. (F) Effect of paragraph Nothing in this paragraph shall preempt a State statute or administrative action, require approval of a State statute or administrative action, or apply section 15 to a State. (10) Review Not less frequently than once every 5 years after the date on which the process under this subsection is established, the Administrator shall— (A) review the process on the basis of experience and taking into consideration resources available to efficiently and effectively screen and prioritize chemical substances; and (B) if necessary, modify the prioritization screening process. (11) Effect Subject to section 18, a designation by the Administrator under this section with respect to a chemical substance shall not affect— (A) the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance; or (B) the regulation of those activities. (c) Additional priorities for safety assessments and determinations (1) Requirements (A) In general The rule promulgated under subsection (a) shall— (i) include a process by which a manufacturer or processor of an active chemical substance that has not been designated a high-priority substance or is not in the process of a prioritization screening by the Administrator, may request that the Administrator designate the substance as an additional priority for a safety assessment and safety determination, subject to the payment of fees pursuant to section 26(b)(3)(D); (ii) specify the information to be provided in such requests; and (iii) specify the criteria (which may include criteria identified in subsection (a)(4)) that the Administrator shall use to determine whether or not to grant such a request, which shall include whether the substance is subject to restrictions imposed by statutes enacted or administrative actions taken by 1 or more States on the manufacture, processing, distribution in commerce, or use of the substance. (B) Preference Subject to paragraph (2), in deciding whether to grant requests under this subsection the Administrator shall give a preference to requests concerning substances for which the Administrator determines that restrictions imposed by 1 or more States have the potential to have a significant impact on interstate commerce or health or the environment. (C) Exceptions Chemical substances for which requests have been granted under this subsection shall not be subject to subsection (a)(3)(A)(iii) or section 18(b). (2) Limitations In considering whether to grant a request submitted under paragraph (1), the Administrator shall ensure that— (A) the number of substances designated to undergo safety assessments and safety determinations under the process and criteria pursuant to paragraph (1) is not less than 25 percent, or more than 30 percent, of the cumulative number of substances designated to undergo safety assessments and safety determinations under subsections (a)(2) and (b)(3) (except that if less than 25 percent are received by the Administrator, the Administrator shall grant each request that meets the requirements of paragraph (1)); (B) the resources allocated to conducting safety assessments and safety determinations for additional priorities designated under this subsection are proportionate to the number of such substances relative to the total number of substances currently designated to undergo safety assessments and safety determinations under this section; and (C) the number of additional priority requests stipulated under subparagraph (A) is in addition to the total number of high-priority substances identified under subsections (a)(2) and (b)(3). (3) Additional review of work plan chemicals for safety assessment and safety determination In the case of a request under paragraph (1) with respect to a chemical substance identified by the Administrator in the October 2014 TSCA Work Plan— (A) the 30-percent cap specified in paragraph (2)(A) shall not apply and the addition of Work Plan chemicals shall be at the discretion of the Administrator; and (B) notwithstanding paragraph (1)(C), requests for additional Work Plan chemicals under this subsection shall be considered high-priority chemicals subject to section 18(b) but not subsection (a)(3)(A)(iii). (4) Requirements (A) In general The public shall be provided notice and an opportunity to comment on requests submitted under this subsection. (B) Decision by Administrator Not later than 180 days after the date on which the Administrator receives a request under this subsection, the Administrator shall decide whether or not to grant the request. (C) Assessment and determination If the Administrator grants a request under this subsection, the safety assessment and safety determination— (i) shall be conducted in accordance with the deadlines and other requirements of sections 3A(i) and 6; and (ii) shall not be expedited or otherwise subject to special treatment relative to high-priority substances designated pursuant to subsection (b)(3) that are undergoing safety assessments and safety determinations. . 7. New chemicals and significant new uses Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) by striking the section designation and heading and inserting the following: 5. New chemicals and significant new uses ; (2) by striking subsection (b); (3) by redesignating subsection (a) as subsection (b); (4) by redesignating subsection (i) as subsection (a) and moving the subsection so as to appear at the beginning of the section; (5) in subsection (b) (as so redesignated)— (A) in the subsection heading, by striking In general and inserting Notices ; (B) in paragraph (1)— (i) in the matter preceding subparagraph (A), by striking subsection (h) and inserting paragraph (3) and subsection (h) ; and (ii) in the matter following subparagraph (B)— (I) by striking subsection (d) and inserting subsection (c) ; and (II) by striking and such person complies with any applicable requirement of subsection (b) ; and (C) by adding at the end the following: (3) Article consideration The Administrator may require notification under this section for the import or processing of a chemical substance as part of an article or category of articles under paragraph (1)(B) if the Administrator makes an affirmative finding in a rule under paragraph (2) that the reasonable potential for exposure to the chemical substance through the article or category of articles subject to the rule warrants notification. ; (6) by redesignating subsections (c) and (d) as subsections (d) and (c), respectively, and moving subsection (c) (as so redesigned) so as appear after subsection (b) (as redesignated by paragraph (3)); (7) in subsection (c) (as so redesignated)— (A) by striking paragraph (1) and inserting the following: (1) In general The notice required by subsection (b) shall include, with respect to a chemical substance— (A) the information required by sections 720.45 and 720.50 of title 40, Code of Federal Regulations (or successor regulations); and (B) all known or reasonably ascertainable information regarding conditions of use and reasonably anticipated exposures. ; (B) in paragraph (2)— (i) in the matter preceding subparagraph (A)— (I) by striking subsection (a) and inserting subsection (b) ; and (II) by striking or of data under subsection (b) ; (ii) in subparagraph (A), by adding and after the semicolon at the end; (iii) in subparagraph (B), by striking ; and and inserting a period; and (iv) by striking subparagraph (C); and (C) in paragraph (3), by striking subsection (a) and for which the notification period prescribed by subsection (a), (b), or (c) and inserting subsection (b) and for which the notification period prescribed by subsection (b) or (d) ; (8) by striking subsection (d) (as redesignated by paragraph (6)) and inserting the following: (d) Review of notice (1) Initial review (A) In general Subject to subparagraph (B), not later than 90 days after the date of receipt of a notice submitted under subsection (b), the Administrator shall— (i) conduct an initial review of the notice; (ii) as needed, develop a profile of the relevant chemical substance and the potential for exposure to humans and the environment; and (iii) make a determination under paragraph (3). (B) Extension Except as provided in paragraph (5), the Administrator may extend the period described in subparagraph (A) for good cause for 1 or more periods, the total of which shall be not more than 90 days. (2) Information sources In evaluating a notice under paragraph (1), the Administrator shall take into consideration— (A) any relevant information identified in subsection (c)(1); and (B) any other relevant additional information available to the Administrator. (3) Determinations Before the end of the applicable period for review under paragraph (1), based on the information described in paragraph (2), and subject to section 18(g), the Administrator shall determine that— (A) the relevant chemical substance or significant new use is not likely to meet the safety standard, in which case the Administrator shall take appropriate action under paragraph (4); (B) the relevant chemical substance or significant new use is likely to meet the safety standard, in which case the Administrator shall allow the review period to expire without additional restrictions; or (C) additional information is necessary in order to make a determination under subparagraph (A) or (B), in which case the Administrator shall take appropriate action under paragraphs (4) and (5). (4) Restrictions (A) Determination by Administrator (i) In general If the Administrator makes a determination under subparagraph (A) or (C) of paragraph (3) with respect to a notice submitted under subsection (b)— (I) the Administrator, before the end of the applicable period for review under paragraph (1) and by consent agreement or order, as appropriate, shall prohibit or otherwise restrict the manufacture, processing, use, distribution in commerce, or disposal (as applicable) of the chemical substance, or of the chemical substance for a significant new use, without compliance with the restrictions specified in the consent agreement or order that the Administrator determines are sufficient to ensure that the chemical substance or significant new use is likely to meet the safety standard; and (II) no person may commence manufacture of the chemical substance, or manufacture or processing of the chemical substance for a significant new use, except in compliance with the restrictions specified in the consent agreement or order. (ii) Likely to meet standard If the Administrator makes a determination under subparagraph (B) of paragraph (3) with respect to a chemical substance or significant new use for which a notice was submitted under subsection (b), then notwithstanding any remaining portion of the applicable period for review under paragraph (1), the submitter of the notice may commence manufacture for commercial purposes of the chemical substance or manufacture or processing of the chemical substance for a significant new use. (B) Requirements Not later than 90 days after issuing a consent agreement or order under subparagraph (A), the Administrator shall— (i) consider whether to promulgate a rule pursuant to subsection (b)(2) that identifies as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance that does not conform to the restrictions imposed by the consent agreement or order; and (ii) (I) initiate a rulemaking described in clause (i); or (II) publish a statement describing the reasons of the Administrator for not initiating a rulemaking. (C) Inclusions A prohibition or other restriction under subparagraph (A) may include, as appropriate— (i) subject to section 18(g), a requirement that a chemical substance shall be marked with, or accompanied by, clear and adequate minimum warnings and instructions with respect to use, distribution in commerce, or disposal, or any combination of those activities, with the form and content of the minimum warnings and instructions to be prescribed by the Administrator (ii) a requirement that manufacturers or processors of the chemical substance shall— (I) make and retain records of the processes used to manufacture or process, as applicable, the chemical substance; or (II) monitor or conduct such additional tests as are reasonably necessary to address potential risks from the manufacture, processing, distribution in commerce, use, or disposal, as applicable, of the chemical substance, subject to section 4; (iii) a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce— (I) in general; or (II) for a particular use; (iv) a prohibition or other restriction of— (I) the manufacture, processing, or distribution in commerce of the chemical substance for a significant new use; (II) any method of commercial use of the chemical substance; or (III) any method of disposal of the chemical substance; or (v) a prohibition or other restriction on the manufacture, processing, or distribution in commerce of the chemical substance— (I) in general; or (II) for a particular use. (D) Persistent and bioaccumulative substances For a chemical substance the Administrator determines, with respect to persistence and bioaccumulation, scores high for 1 and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012, the Administrator shall, in selecting among prohibitions and other restrictions that the Administrator determines are sufficient to ensure that the chemical substance is likely to meet the safety standard, reduce potential exposure to the substance to the maximum extent practicable. (E) Workplace exposures To the extent practicable, the Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health prior to adopting any prohibition or other restriction under this subsection to address workplace exposures. (F) Definition of requirement For purposes of this Act, the term requirement as used in this section does not displace common law. (5) Additional information If the Administrator determines under paragraph (3)(C) that additional information is necessary to conduct a review under this subsection, the Administrator— (A) shall provide an opportunity for the submitter of the notice to submit the additional information; (B) may, by agreement with the submitter, extend the review period for a reasonable time to allow the development and submission of the additional information; (C) may promulgate a rule, enter into a testing consent agreement, or issue an order under section 4 to require the development of the information; and (D) on receipt of information the Administrator finds supports the determination under paragraph (3), shall promptly make the determination. ; (9) by striking subsections (e) through (g) and inserting the following: (e) Notice of commencement (1) In general Not later than 30 days after the date on which a manufacturer that has submitted a notice under subsection (b) commences nonexempt commercial manufacture of a chemical substance, the manufacturer shall submit to the Administrator a notice of commencement that identifies— (A) the name of the manufacturer; and (B) the initial date of nonexempt commercial manufacture. (2) Withdrawal A manufacturer or processor that has submitted a notice under subsection (b), but that has not commenced nonexempt commercial manufacture or processing of the chemical substance, may withdraw the notice. (f) Further evaluation The Administrator may review a chemical substance under section 4A at any time after the Administrator receives— (1) a notice of commencement for a chemical substance under subsection (e); or (2) new information regarding the chemical substance. (g) Transparency Subject to section 14, the Administrator shall make available to the public— (1) all notices, determinations, consent agreements, rules, and orders submitted under this section or made by the Administrator under this section; and (2) all information submitted or issued under this section. ; and (10) in subsection (h)— (A) in paragraph (1)— (i) in the matter preceding subparagraph (A), by striking (a) or ; and (ii) in subparagraph (A), by inserting , without taking into account cost or other nonrisk factors after the environment ; (B) by striking paragraph (2); (C) by redesignating paragraphs (3) through (6) as paragraphs (2) through (5), respectively; (D) in paragraph (2) (as so redesignated), in the matter preceding subparagraph (A), by striking subsections (a) and (b) and inserting subsection (b) ; (E) in paragraph (3) (as so redesignated)— (i) in the first sentence, by striking will not present an unreasonable risk of injury to health or the environment and inserting will meet the safety standard ; and (ii) by striking the second sentence; (F) in paragraph (4) (as so redesignated), by striking subsections (a) and (b) and inserting subsection (b) ; and (G) in paragraph (5) (as so redesignated), in the first sentence, by striking paragraph (1) or (5) and inserting paragraph (1) or (4) . 8. Safety assessments and safety determinations Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— (1) by striking the section designation and heading and inserting the following: 6. Safety assessments and safety determinations ; (2) by redesignating subsections (e) and (f) as subsections (h) and (i), respectively; (3) by striking subsections (a) through (d) and inserting the following: (a) In general The Administrator— (1) shall conduct a safety assessment and make a safety determination of each high-priority substance in accordance with subsections (b) and (c); (2) shall, as soon as practicable and not later than 6 months after the date on which a chemical substance is designated as a high-priority substance, define and publish the scope of the safety assessment and safety determination to be conducted pursuant to this section, including the hazards, exposures, conditions of use, and potentially exposed or susceptible populations that the Administrator expects to consider; (3) as appropriate based on the results of a safety determination, shall establish restrictions pursuant to subsection (d); (4) shall complete and publish a safety assessment and safety determination not later than 3 years after the date on which a chemical substance is designated as a high-priority substance; (5) shall promulgate any necessary final rule pursuant to subsection (d) by not later than 2 years after the date on which the safety determination is completed; (6) may extend any deadline under paragraph (4) for not more than 1 year, if information relating to the high-priority substance, required to be developed in a rule, order, or consent agreement under section 4— (A) has not yet been submitted to the Administrator; or (B) was submitted to the Administrator— (i) within the time specified in the rule, order, or consent agreement pursuant to section 4(a)(4)(A)(iv); and (ii) on or after the date that is 120 days before the expiration of the deadline described in paragraph (4); and (7) may extend the deadline under paragraph (5) for not more than 2 years, subject to the condition that the aggregate length of all extensions of deadlines under this subsection does not exceed 2 years. (b) Prior actions and notice of existing information (1) Prior-initiated assessments (A) In general Nothing in this Act prevents the Administrator from initiating a safety assessment or safety determination regarding a chemical substance, or from continuing or completing such a safety assessment or safety determination, prior to the effective date of the policies, procedures, and guidance required to be established by the Administrator under section 3A or 4A. (B) Integration of prior policies and procedures As policies and procedures under section 3A and 4A are established, to the maximum extent practicable, the Administrator shall integrate the policies and procedures into ongoing safety assessments and safety determinations. (2) Actions completed prior to completion of policies and procedures Nothing in this Act requires the Administrator to revise or withdraw a completed safety assessment, safety determination, or rule solely because the action was completed prior to the completion of a policy or procedure established under section 3A or 4A, and the validity of a completed assessment, determination, or rule shall not be determined based on the content of such a policy or procedure. (3) Notice of existing information (A) In general The Administrator shall, where such information is available, take notice of existing information regarding hazard and exposure published by other Federal agencies and the National Academies and incorporate the information in safety assessments and safety determinations with the objective of increasing the efficiency of the safety assessments and safety determinations. (B) Inclusion of information Existing information described in subparagraph (A) should be included to the extent practicable and where the Administrator determines the information is relevant and scientifically reliable. (c) Safety determinations (1) In general Based on a review of the information available to the Administrator, including draft safety assessments submitted by interested persons pursuant to section 3A(h)(2)(D), and subject to section 18(g), the Administrator shall determine— (A) by order, that the relevant chemical substance meets the safety standard; (B) that the relevant chemical substance does not meet the safety standard, in which case the Administrator shall, by rule under subsection (d)— (i) impose restrictions necessary to ensure that the chemical substance meets the safety standard under the conditions of use; or (ii) if the safety standard cannot be met with the application of other restrictions under subsection (d)(3), ban or phase out the chemical substance, as appropriate; or (C) that additional information is necessary in order to make a determination under subparagraph (A) or (B), in which case the Administrator shall take appropriate action under paragraph (2). (2) Additional information If the Administrator determines that additional information is necessary to make a safety assessment or safety determination for a high-priority substance, the Administrator— (A) shall provide an opportunity for interested persons to submit the additional information; (B) may promulgate a rule, enter into a testing consent agreement, or issue an order under section 4 to require the development of the information; (C) may defer, for a reasonable period consistent with the deadlines described in subsection (a), a safety assessment and safety determination until after receipt of the information; and (D) consistent with the deadlines described in subsection (a), on receipt of information the Administrator finds supports the safety assessment and safety determination, shall make a determination under paragraph (1). (3) Establishment of deadline In requesting the development or submission of information under this section, the Administrator shall establish a deadline for the submission of the information. (d) Rule (1) Implementation If the Administrator makes a determination under subsection (c)(1)(B) with respect to a chemical substance, the Administrator shall promulgate a rule establishing restrictions necessary to ensure that the chemical substance meets the safety standard. (2) Scope (A) In general The rule promulgated pursuant to this subsection— (i) may apply to mixtures containing the chemical substance, as appropriate; (ii) shall include dates by which compliance is mandatory, which— (I) shall be as soon as practicable, but not later than 4 years after the date of promulgation of the rule, except in the case of a use exempted under paragraph (5); (II) in the case of a ban or phase-out of the chemical substance, shall implement the ban or phase-out in as short a period as practicable; (III) as determined by the Administrator, may vary for different affected persons; and (IV) following a determination by the Administrator that compliance is technologically or economically infeasible within the timeframe specified in subclause (I), shall provide up to an additional 18 months for compliance to be mandatory; (iii) shall exempt replacement parts that are manufactured prior to the effective date of the rule for articles that are first manufactured prior to the effective date of the rule unless the Administrator finds the replacement parts contribute significantly to the identified risk; (iv) shall, in selecting among prohibitions and other restrictions, apply such prohibitions or other restrictions to an article or category of articles containing the chemical substance only to the extent necessary to address the identified risks from exposure to the chemical substance from the article or category of articles, in order to determine that the chemical substance meets the safety standard; and (v) shall, when the Administrator determines that the chemical substance does not meet the safety standard for a potentially exposed or susceptible population, apply prohibitions or other restrictions necessary to ensure that the substance meets the safety standard for that population. (B) Persistent and bioaccumulative substances For a chemical substance the Administrator determines, with respect to persistence and bioaccumulation, scores high for 1 and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012, the Administrator shall, in selecting among prohibitions and other restrictions that the Administrator determines are sufficient to ensure that the chemical substance meets the safety standard, reduce exposure to the substance to the maximum extent practicable. (C) Workplace exposures The Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health before adopting any prohibition or other restriction under this subsection to address workplace exposures. (D) Definition of requirement For the purposes of this Act, the term requirement as used in this section does not displace common law. (3) Restrictions Subject to section 18, a restriction under paragraph (1) may include, as appropriate— (A) a requirement that a chemical substance shall be marked with, or accompanied by, clear and adequate minimum warnings and instructions with respect to use, distribution in commerce, or disposal, or any combination of those activities, with the form and content of the minimum warnings and instructions to be prescribed by the Administrator; (B) a requirement that manufacturers or processors of the chemical substance shall— (i) make and retain records of the processes used to manufacture or process the chemical substance; (ii) describe and apply the relevant quality control procedures followed in the manufacturing or processing of the substance; or (iii) monitor or conduct tests that are reasonably necessary to ensure compliance with the requirements of any rule under this subsection; (C) a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce; (D) a requirement to ban or phase out, or otherwise restrict the manufacture, processing, or distribution in commerce of the chemical substance for— (i) a particular use; (ii) a particular use at a concentration in excess of a level specified by the Administrator; or (iii) all uses; (E) a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce for— (i) a particular use; or (ii) a particular use at a concentration in excess of a level specified by the Administrator; (F) a requirement to ban, phase out, or otherwise restrict any method of commercial use of the chemical substance; (G) a requirement to ban, phase out, or otherwise restrict any method of disposal of the chemical substance or any article containing the chemical substance; and (H) a requirement directing manufacturers or processors of the chemical substance to give notice of the Administrator’s determination under subsection (c)(1)(B) to distributors in commerce of the chemical substance and, to the extent reasonably ascertainable, to other persons in the chain of commerce in possession of the chemical substance. (4) Analysis for rulemaking (A) Considerations In deciding which restrictions to impose under paragraph (3) as part of developing a rule under paragraph (1), the Administrator shall take into consideration, to the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator. (B) Alternatives As part of the analysis, the Administrator shall review any 1 or more technically and economically feasible alternatives to the chemical substance that the Administrator determines are relevant to the rulemaking. (C) Public availability In proposing a rule under paragraph (1), the Administrator shall make publicly available any analysis conducted under this paragraph. (D) Statement required In making final a rule under paragraph (1), the Administrator shall include a statement describing how the analysis considered under subparagraph (A) was taken into account. (5) Exemptions (A) In general The Administrator may, as part of a rule promulgated under paragraph (1) or in a separate rule, exempt 1 or more uses of a chemical substance from any restriction in a rule promulgated under paragraph (1) if the Administrator determines that— (i) the restriction cannot be complied with, without— (I) harming national security; (II) causing significant disruption in the national economy due to the lack of availability of a chemical substance; or (III) interfering with a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; or (ii) the use of the chemical substance, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. (B) Exemption analysis In proposing a rule under this paragraph, the Administrator shall make publicly available any analysis conducted under this paragraph to assess the need for the exemption. (C) Statement required In making final a rule under this paragraph, the Administrator shall include a statement describing how the analysis considered under subparagraph (B) was taken into account. (D) Analysis in case of ban or phase-out In determining whether an exemption should be granted under this paragraph for a chemical substance for which a ban or phase-out is included in a proposed or final rule under paragraph (1), the Administrator shall take into consideration, to the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the 1 or more alternatives to the chemical substance the Administrator determines to be technically and economically feasible and most likely to be used in place of the chemical substance under the conditions of use. (E) Conditions As part of a rule promulgated under this paragraph, the Administrator shall include conditions, including reasonable recordkeeping, monitoring, and reporting requirements, to the extent that the Administrator determines the conditions are necessary to protect health and the environment while achieving the purposes of the exemption. (F) Duration (i) In general The Administrator shall establish, as part of a rule under this paragraph, a time limit on any exemption for a time to be determined by the Administrator as reasonable on a case-by-case basis. (ii) Authority of Administrator The Administrator, by rule, may extend, modify, or eliminate an exemption if the Administrator determines, on the basis of reasonably available information and after adequate public justification, the exemption warrants extension or is no longer necessary. (iii) Considerations (I) In general Subject to subclause (II), the Administrator shall issue exemptions and establish time periods by considering factors determined by the Administrator to be relevant to the goals of fostering innovation and the development of alternatives that meet the safety standard. (II) Limitation Any renewal of an exemption in the case of a rule under paragraph (1) requiring the ban or phase-out of a chemical substance shall not exceed 5 years. (e) Immediate effect The Administrator may declare a proposed rule under subsection (d)(1) to be effective on publication of the rule in the Federal Register and until the effective date of final action taken respecting the rule, if— (1) the Administrator determines that— (A) the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance or mixture subject to the proposed rule or any combination of those activities is likely to result in a risk of serious or widespread injury to health or the environment before the effective date; and (B) making the proposed rule so effective is necessary to protect the public interest; and (2) in the case of a proposed rule to prohibit the manufacture, processing, or distribution in commerce of a chemical substance or mixture because of the risk determined under paragraph (1)(A), a court has granted relief in an action under section 7 with respect to that risk associated with the chemical substance or mixture. (f) Final agency action Under this section and subject to section 18— (1) a safety determination, and the associated safety assessment, for a chemical substance that the Administrator determines under subsection (c) meets the safety standard, shall be considered to be a final agency action, effective beginning on the date of issuance of the final safety determination; and (2) a final rule promulgated under subsection (d)(1), and the associated safety assessment and safety determination that a chemical substance does not meet the safety standard, shall be considered to be a final agency action, effective beginning on the date of promulgation of the final rule. (g) Extension of deadlines for certain chemical substances The Administrator may not extend any deadline under subsection (a) for a chemical substance designated as a high priority that is listed in the 2014 update of the TSCA Work Plan without adequate public justification that demonstrates, following a review of the information reasonably available to the Administrator, that the Administrator cannot adequately complete a safety assessment and safety determination, or a final rule pursuant to subsection (d), without additional information regarding the chemical substance. ; and (4) in subsection (h) (as redesignated by paragraph (2))— (A) by striking paragraph (4); and (B) by redesignating paragraph (5) as paragraph (4). 9. Imminent hazards Section 7 of the Toxic Substances Control Act ( 15 U.S.C. 2606 ) is amended— (1) by striking subsection (a) and inserting the following: (a) Civil actions (1) In general The Administrator may commence a civil action in an appropriate United States district court for— (A) seizure of an imminently hazardous chemical substance or mixture or any article containing the chemical substance or mixture; (B) relief (as authorized by subsection (b)) against any person that manufactures, processes, distributes in commerce, uses, or disposes of, an imminently hazardous chemical substance or mixture or any article containing the chemical substance or mixture; or (C) both seizure described in subparagraph (A) and relief described in subparagraph (B). (2) Rule, order, or other proceeding A civil action may be commenced under this paragraph, notwithstanding— (A) the existence of a decision, rule, consent agreement, or order by the Administrator under section 4, 4A, 5, or 6 or title IV or VI; or (B) the pendency of any administrative or judicial proceeding under any provision of this Act. ; (2) in subsection (b)(1), by striking unreasonable ; (3) in subsection (d), by striking section 6(a) and inserting section 6(d) ; and (4) in subsection (f), in the first sentence, by striking and unreasonable . 10. Information collection and reporting Section 8 of the Toxic Substances Control Act ( 15 U.S.C. 2607 ) is amended— (1) in subsection (a)— (A) in paragraph (3)— (i) in subparagraph (A)(ii)(I)— (I) by striking 5(b)(4) and inserting 5 ; (II) by inserting section 4 or after in effect under ; and (III) by striking 5(e), and inserting 5(d)(4); ; and (ii) by adding at the end the following: (C) Not later than 180 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and not less frequently than once every 10 years thereafter, the Administrator, after consultation with the Administrator of the Small Business Administration, shall— (i) review the adequacy of the standards prescribed according to subparagraph (B); (ii) after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted; and (iii) revise the standards if the Administrator so determines. ; and (B) by adding at the end the following: (4) Rules (A) Deadline (i) In general Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall promulgate rules requiring the maintenance of records and the reporting of additional information known or reasonably ascertainable by the person making the report, including rules applicable to processors so that the Administrator has the information necessary to carry out this title. (ii) Modification of prior rules In carrying out this subparagraph, the Administrator may modify, as appropriate, rules promulgated before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (B) Contents The rules promulgated pursuant to subparagraph (A)— (i) may impose different reporting and recordkeeping requirements on manufacturers and processors; and (ii) shall include the level of detail necessary to be reported, including the manner by which use and exposure information may be reported. (C) Administration In implementing the reporting and recordkeeping requirements under this paragraph, the Administrator shall take measures— (i) to limit the potential for duplication in reporting requirements; (ii) to minimize the impact of the rules on small manufacturers and processors; and (iii) to apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this title. ; (2) in subsection (b), by adding at the end the following: (3) Nomenclature (A) In general In carrying out paragraph (1), the Administrator shall— (i) maintain the use of Class 2 nomenclature in use on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ; (ii) maintain the use of the Soap and Detergent Association Nomenclature System, published in March 1978 by the Administrator in section 1 of addendum III of the document entitled Candidate List of Chemical Substances , and further described in the appendix A of volume I of the 1985 edition of the Toxic Substances Control Act Substances Inventory (EPA Document No. EPA–560/7–85–002a); and (iii) treat all components of categories that are considered to be statutory mixtures under this Act as being included on the list published under paragraph (1) under the Chemical Abstracts Service numbers for the respective categories, including, without limitation— (I) cement, Portland, chemicals, CAS No. 65997–15–1; (II) cement, alumina, chemicals, CAS No. 65997–16–2; (III) glass, oxide, chemicals, CAS No. 65997–17–3; (IV) frits, chemicals, CAS No. 65997–18–4; (V) steel manufacture, chemicals, CAS No. 65997–19–5; and (VI) ceramic materials and wares, chemicals, CAS No. 66402–68–4. (B) Multiple nomenclature conventions (i) In general If an existing guidance allows for multiple nomenclature conventions, the Administrator shall— (I) maintain the nomenclature conventions for substances; and (II) develop new guidance that— (aa) establishes equivalency between the nomenclature conventions for chemical substances on the list published under paragraph (1); and (bb) permits persons to rely on the new guidance for purposes of determining whether a chemical substance is on the list published under paragraph (1). (ii) Multiple CAS numbers For any chemical substance appearing multiple times on the list under different Chemical Abstracts Service numbers, the Administrator shall develop guidance recognizing the multiple listings as a single chemical substance. (4) Chemical substances in commerce (A) Rules (i) In general Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator, by rule, shall require manufacturers and processors to notify the Administrator, by not later than 180 days after the date of promulgation of the rule, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (ii) Active substances The Administrator shall designate chemical substances for which notices are received under clause (i) to be active substances on the list published under paragraph (1). (iii) Inactive substances The Administrator shall designate chemical substances for which no notices are received under clause (i) to be inactive substances on the list published under paragraph (1). (B) Confidential chemical substances In promulgating the rule established pursuant to subparagraph (A), the Administrator shall— (i) maintain the list under paragraph (1), which shall include a confidential portion and a nonconfidential portion consistent with this section and section 14; (ii) require a manufacturer or processor that is submitting a notice pursuant to subparagraph (A) for a chemical substance on the confidential portion of the list published under paragraph (1) to indicate in the notice whether the manufacturer or processor seeks to maintain any existing claim for protection against disclosure of the specific identity of the substance as confidential pursuant to section 14; and (iii) require the substantiation of those claims pursuant to section 14 and in accordance with the review plan described in subparagraph (C). (C) Review plan Not later than 1 year after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A), the Administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific identities of chemical substances on the confidential portion of the list published under paragraph (1) that are asserted pursuant to subparagraph (B). (D) Requirements of review plan Under the review plan under subparagraph (C), the Administrator shall— (i) require, at the time requested by the Administrator, all manufacturers or processors asserting claims under subparagraph (B) to substantiate the claim unless the manufacturer or processor has substantiated the claim in a submission made to the Administrator during the 5-year period ending on the date of the request by the Administrator; (ii) in accordance with section 14— (I) review each substantiation— (aa) submitted pursuant to clause (i) to determine if the claim warrants protection from disclosure; and (bb) submitted previously by a manufacturer or processor and relied on in lieu of the substantiation required pursuant to clause (i), if the substantiation has not been previously reviewed by the Administrator, to determine if the claim warrants protection from disclosure; (II) approve, modify, or deny each claim; and (III) except as provided in this section and section 14, protect from disclosure information for which the Administrator approves such a claim for a period of 10 years, unless, prior to the expiration of the period— (aa) the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall promptly make the information available to the public; or (bb) the Administrator otherwise becomes aware that the need for protection from disclosure can no longer be substantiated, in which case the Administrator shall take the actions described in section 14(g)(2); and (iii) encourage manufacturers or processors that have previously made claims to protect the specific identities of chemical substances identified as inactive pursuant to subsection (f)(2) to review and either withdraw or substantiate the claims. (E) Timeline for completion of reviews (i) In general The Administrator shall implement the review plan so as to complete reviews of all claims specified in subparagraph (C) not later than 5 years after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A). (ii) Considerations (I) In general The Administrator may extend the deadline for completion of the reviews for not more than 2 additional years, after an adequate public justification, if the Administrator determines that the extension is necessary based on the number of claims needing review and the available resources. (II) Annual review goal and results At the beginning of each year, the Administrator shall publish an annual goal for reviews and the number of reviews completed in the prior year. (5) Active and inactive substances (A) In general The Administrator shall maintain and keep current designations of active substances and inactive substances on the list published under paragraph (1). (B) Change to active status (i) In general Any person that intends to manufacture or process for a nonexempt commercial purpose a chemical substance that is designated as an inactive substance shall notify the Administrator before the date on which the inactive substance is manufactured or processed. (ii) Confidential chemical identity claims If a person submitting a notice under clause (i) for an inactive substance on the confidential portion of the list published under paragraph (1) seeks to maintain an existing claim for protection against disclosure of the specific identity of the inactive substance as confidential, the person shall— (I) in the notice submitted under clause (i), assert the claim; and (II) by not later than 30 days after providing the notice under clause (i), substantiate the claim. (iii) Active status On receiving a notification under clause (i), the Administrator shall— (I) designate the applicable chemical substance as an active substance; (II) pursuant to section 14, promptly review any claim and associated substantiation submitted pursuant to clause (ii) for protection against disclosure of the specific identity of the chemical substance and approve, modify, or deny the claim; (III) except as provided in this section and section 14, protect from disclosure the specific identity of the chemical substance for which the Administrator approves a claim under subclause (II) for a period of 10 years, unless, prior to the expiration of the period— (aa) the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall promptly make the information available to the public; or (bb) the Administrator otherwise becomes aware that the need for protection from disclosure can no longer be substantiated, in which case the Administrator shall take the actions described in section 14(g)(2); and (IV) pursuant to section 4A, review the priority of the chemical substance as the Administrator determines to be necessary. (C) Category status The list of inactive substances shall not be considered to be a category for purposes of section 26(c). (6) Interim list of active substances Prior to the promulgation of the rule required under paragraph (4)(A), the Administrator shall designate the chemical substances reported under part 711 of title 40, Code of Federal Regulations (as in effect on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ), during the reporting period that most closely preceded the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , as the interim list of active substances for the purposes of section 4A. (7) Public information Subject to this subsection, the Administrator shall make available to the public— (A) the specific identity of each chemical substance on the nonconfidential portion of the list published under paragraph (1) that the Administrator has designated as— (i) an active substance; or (ii) an inactive substance; (B) the accession number, generic name, and, if applicable, premanufacture notice case number for each chemical substance on the confidential portion of the list published under paragraph (1) for which a claim of confidentiality was received; and (C) subject to subsections (f) and (g) of section 14, the specific identity of any active substance for which— (i) a claim for protection against disclosure of the specific identity of the active chemical substance was not asserted, as required under this subsection or subsection (d) or (f) of section 14; (ii) a claim for protection against disclosure of the specific identity of the active substance has been denied by the Administrator; or (iii) the time period for protection against disclosure of the specific identity of the active substance has expired. (8) Limitation No person may assert a new claim under this subsection for protection from disclosure of a specific identity of any active or inactive chemical substance for which a notice is received under paragraph (4)(A)(i) or (5)(C)(i) that is not on the confidential portion of the list published under paragraph (1). (9) Certification Under the rules promulgated under this subsection, manufacturers and processors shall be required— (A) to certify that each notice or substantiation the manufacturer or processor submits complies with the requirements of the rule, and that any confidentiality claims are true and correct; and (B) to retain a record supporting the certification for a period of 5 years beginning on the last day of the submission period. ; (3) in subsection (e)— (A) by striking Any person and inserting the following: (1) In general Any person ; and (B) by adding at the end the following: (2) Additional information Any person may submit to the Administrator information reasonably supporting the conclusion that a chemical substance or mixture presents, will present, or does not present a substantial risk of injury to health and the environment. ; and (4) in subsection (f), by striking For purposes of this section, the and inserting the following: In this section: (1) Active substance The term active substance means a chemical substance— (A) that has been manufactured or processed for a nonexempt commercial purpose at any point during the 10-year period ending on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ; (B) that is added to the list published under subsection (b)(1) after that date of enactment; or (C) for which a notice is received under subsection (b)(5)(C). (2) Inactive substance The term inactive substance means a chemical substance on the list published under subsection (b)(1) that does not meet any of the criteria described in paragraph (1). (3) Manufacture; process The . 11. Relationship to other Federal laws Section 9 of the Toxic Substances Control Act ( 15 U.S.C. 2608 ) is amended— (1) in subsection (a)— (A) in paragraph (1), in the first sentence— (i) by striking presents or will present an unreasonable risk to health or the environment and inserting does not or will not meet the safety standard ; and (ii) by striking such risk the first place it appears and inserting the risk posed by the substance or mixture ; (B) in paragraph (2)— (i) in subparagraph (A), by inserting within the time period specified by the Administrator in the report after issues an order ; (ii) in subparagraph (B), by inserting responds within the time period specified by the Administrator in the report and before initiates, within 90 days ; and (iii) in the matter following subparagraph (B), by striking section 6 or 7 and inserting section 6(d) or section 7 ; (C) by redesignating paragraph (3) as paragraph (6); (D) in paragraph (6) (as so redesignated), by striking section 6 or 7 and inserting section 6(d) or 7 ; and (E) by inserting after paragraph (2) the following: (3) The Administrator shall take the actions described in paragraph (4) if the Administrator makes a report under paragraph (1) with respect to a chemical substance or mixture and the agency to which the report was made does not— (A) issue the order described in paragraph (2)(A) within the time period specified by the Administrator in the report; or (B) (i) respond under paragraph (1) within the time frame specified by the Administrator in the report; and (ii) initiate action within 90 days of publication in the Federal Register of the response described in clause (i). (4) If an agency to which a report under paragraph (1) does not take the actions described in subparagraphs (A) or (B) of paragraph (3), the Administrator shall— (A) if a safety assessment and safety determination for the substance under section 6 has not been completed, complete the safety assessment and safety determination; (B) if the Administrator has determined or determines that the chemical substance does not meet the safety standard, initiate action under section 6(d) with respect to the risk; or (C) take any action authorized or required under section 7, as appropriate. (5) This subsection shall not relieve the Administrator of any obligation to complete a safety assessment and safety determination or take any required action under section 6(d) or 7 to address risks from the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or any combination of those activities, that are not identified in a report issued by the Administrator under paragraph (1). ; (2) in subsection (d), in the first sentence, by striking Health, Education, and Welfare and inserting Health and Human Services ; and (3) by adding at the end the following: (e) Exposure information If the Administrator obtains information related to exposures or releases of a chemical substance that may be prevented or reduced under another Federal law, including laws not administered by the Administrator, the Administrator shall make such information available to the relevant Federal agency or office of the Environmental Protection Agency. . 12. Research, development, collection, dissemination, and utilization of data Section 10 of the Toxic Substances Control Act ( 15 U.S.C. 2609 ) is amended by striking Health, Education, and Welfare each place it appears and inserting Health and Human Services . 13. Exports Section 12 of the Toxic Substances Control Act ( 15 U.S.C. 2611 ) is amended— (1) in subsection (a), by striking paragraph (2) and inserting the following: (2) Exception Paragraph (1) shall not apply to— (A) any new chemical substance that the Administrator determines is likely to present an unreasonable risk of injury to health within the United States or to the environment of the United States, without taking into account cost or other non-risk factors; (B) any chemical substance that the Administrator determines presents or will present an unreasonable risk of injury to health within the United States or to the environment of the United States, without taking into account cost or other non-risk factors; or (C) any chemical substance that— (i) the Administrator determines is likely to present an unreasonable risk of injury to health within the United States or to the environment of the United States, without taking into account cost or other non-risk factors; and (ii) is subject to restriction under section 5(d)(4). (3) Waivers for certain mixtures and articles For a mixture or article containing a chemical substance described in paragraph (2), the Administrator may— (A) determine that paragraph (1) shall not apply to the mixture or article; or (B) establish a threshold concentration in a mixture or article at which paragraph (1) shall not apply. (4) Testing The Administrator may require testing under section 4 of any chemical substance or mixture exempted from this Act under paragraph (1) for the purpose of determining whether the chemical substance meets the safety standard within the United States. ; (2) by striking subsection (b) and inserting the following: (b) Notice (1) In general A person shall notify the Administrator that the person is exporting or intends to export to a foreign country— (A) a chemical substance or a mixture containing a chemical substance that the Administrator has determined under section 5 is not likely to meet the safety standard and for which a prohibition or other restriction has been proposed or established under that section; (B) a chemical substance or a mixture containing a chemical substance that the Administrator has determined under section 6 does not meet the safety standard and for which a prohibition or other restriction has been proposed or established under that section; (C) a chemical substance for which the United States is obligated by treaty to provide export notification; (D) a chemical substance or mixture containing a chemical substance subject to a proposed or promulgated significant new use rule, or a prohibition or other restriction pursuant to a rule, order, or consent agreement in effect under this Act; (E) a chemical substance or mixture for which the submission of information is required under section 4; or (F) a chemical substance or mixture for which an action is pending or for which relief has been granted under section 7. (2) Rules (A) In general The Administrator shall promulgate rules to carry out paragraph (1). (B) Contents The rules promulgated pursuant to subparagraph (A) shall— (i) include such exemptions as the Administrator determines to be appropriate, which may include exemptions identified under section 5(h); and (ii) indicate whether, or to what extent, the rules apply to articles containing a chemical substance or mixture described in paragraph (1). (3) Notification The Administrator shall submit to the government of each country to which a chemical substance or mixture is exported— (A) for a chemical substance or mixture described in subparagraph (A), (B), (D), or (F) of paragraph (1), a notice of the determination, rule, order, consent agreement, action, relief, or requirement; (B) for a chemical substance described in paragraph (1)(C), a notice that satisfies the obligation of the United States under the applicable treaty; and (C) for a chemical substance or mixture described in paragraph (1)(E), a notice of availability of the information on the chemical substance or mixture submitted to the Administrator. ; and (3) in subsection (c), by striking paragraph (3). 14. Confidential information Section 14 of the Toxic Substances Control Act ( 15 U.S.C. 2613 ) is amended to read as follows: 14. Confidential information (a) In general Except as otherwise provided in this section, the Administrator shall not disclose information that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, under subsection (b)(4) of that section— (1) that is reported to, or otherwise obtained by, the Administrator under this Act; and (2) for which the requirements of subsection (d) are met. (b) Information generally protected from disclosure The following information specific to, and submitted by, a manufacturer, processor, or distributor that meets the requirements of subsections (a) and (d) shall be presumed to be protected from disclosure, subject to the condition that nothing in this Act prohibits the disclosure of any such information, or information that is the subject of subsection (g)(3), through discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law: (1) Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article. (2) Marketing and sales information. (3) Information identifying a supplier or customer. (4) Details of the full composition of a mixture and the respective percentages of constituents. (5) Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or product. (6) Specific production or import volumes of the manufacturer. (7) Specific aggregated volumes across manufacturers, if the Administrator determines that disclosure of the specific aggregated volumes would reveal confidential information. (8) Except as otherwise provided in this section, the specific identity of a chemical substance prior to the date on which the chemical substance is first offered for commercial distribution, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify a specific chemical substance, if the specific identity was claimed as confidential information at the time it was submitted in a notice under section 5. (c) Information not protected from disclosure (1) In general Notwithstanding subsections (a) and (b), the following information shall not be protected from disclosure: (A) Information from health and safety studies (i) In general Subject to clause (ii)— (I) any health and safety study that is submitted under this Act with respect to— (aa) any chemical substance or mixture that, on the date on which the study is to be disclosed, has been offered for commercial distribution; or (bb) any chemical substance or mixture for which— (AA) testing is required under section 4; or (BB) a notification is required under section 5; or (II) any information reported to, or otherwise obtained by, the Administrator from a health and safety study relating to a chemical substance or mixture described in item (aa) or (bb) of subclause (I). (ii) Effect of subparagraph Nothing in this subparagraph authorizes the release of any information that discloses— (I) a process used in the manufacturing or processing of a chemical substance or mixture; or (II) in the case of a mixture, the portion of the mixture comprised by any chemical substance in the mixture. (B) Other information not protected from disclosure (i) For information submitted after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the specific identity of a chemical substance as of the date on which the chemical substance is first offered for commercial distribution, if the person submitting the information does not meet the requirements of subsection (d). (ii) A safety assessment developed, or a safety determination made, under section 6. (iii) Any general information describing the manufacturing volumes, expressed as specific aggregated volumes or, if the Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges. (iv) A general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector. (2) Mixed confidential and nonconfidential information Any information that is eligible for protection under this section and is submitted with information described in this subsection shall be protected from disclosure, if the submitter complies with subsection (d), subject to the condition that information in the submission that is not eligible for protection against disclosure shall be disclosed. (3) Ban or phase-out If the Administrator promulgates a rule pursuant to section 6(d) that establishes a ban or phase-out of the manufacture, processing, or distribution in commerce of a chemical substance, subject to paragraphs (2), (3), and (4) of subsection (g), any protection from disclosure provided under this section with respect to the specific identity of the chemical substance and other information relating to the chemical substance shall no longer apply. (4) Certain requests If a request is made to the Administrator under section 552(a) of title 5, United States Code, for information that is subject to disclosure under this subsection, the Administrator may not deny the request on the basis of section 552(b)(4) of title 5, United States Code. (d) Requirements for confidentiality claims (1) Assertion of claims (A) In general A person seeking to protect any information submitted under this Act from disclosure (including information described in subsection (b)) shall assert to the Administrator a claim for protection concurrent with submission of the information, in accordance with such rules regarding a claim for protection from disclosure as the Administrator has promulgated or may promulgate pursuant to this title. (B) Inclusion An assertion of a claim under subparagraph (A) shall include a statement that the person has— (i) taken reasonable measures to protect the confidentiality of the information; (ii) determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (iii) a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and (iv) a reasonable basis to believe that the information is not readily discoverable through reverse engineering. (C) Specific chemical identity In the case of a claim under subparagraph (A) for protection against disclosure of a specific chemical identity, the claim shall include a structurally descriptive generic name for the chemical substance that the Administrator may disclose to the public, subject to the condition that the generic name shall— (i) be consistent with guidance issued by the Administrator under paragraph (3)(A); and (ii) describe the chemical structure of the substance as specifically as practicable while protecting those features of the chemical structure— (I) that are considered to be confidential; and (II) the disclosure of which would be likely to cause substantial harm to the competitive position of the person. (D) Public information No person may assert a claim under this section for protection from disclosure of information that is already publicly available. (2) Additional requirements for confidentiality claims Except for information described in subsection (b), a person asserting a claim to protect information from disclosure under this Act shall substantiate the claim, in accordance with the rules promulgated and consistent with the guidance issued by the Administrator. (3) Guidance The Administrator shall develop guidance regarding— (A) the determination of structurally descriptive generic names, in the case of claims for the protection against disclosure of specific chemical identity; and (B) the content and form of the statements of need and agreements required under paragraphs (4), (5), and (6) of subsection (e). (4) Certification An authorized official of a person described in paragraph (1)(A) shall certify that the statement required to assert a claim submitted pursuant to paragraph (1)(B) and any information required to substantiate a claim submitted pursuant to paragraph (2) are true and correct. (e) Exceptions to protection from disclosure Information described in subsection (a)— (1) shall be disclosed if the information is to be disclosed to an officer or employee of the United States in connection with the official duties of the officer or employee— (A) under any law for the protection of health or the environment; or (B) for a specific law enforcement purpose; (2) shall be disclosed if the information is to be disclosed to a contractor of the United States and employees of that contractor— (A) if, in the opinion of the Administrator, the disclosure is necessary for the satisfactory performance by the contractor of a contract with the United States for the performance of work in connection with this Act; and (B) subject to such conditions as the Administrator may specify; (3) shall be disclosed if the Administrator determines that disclosure is necessary to protect health or the environment; (4) shall be disclosed if the information is to be disclosed to a State or political subdivision of a State, on written request, for the purpose of development, administration, or enforcement of a law, if 1 or more applicable agreements with the Administrator that are consistent with the guidance issued under subsection (d)(3)(B) ensure that the recipient will take appropriate measures, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures comparable to the procedures used by the Administrator to safeguard the information; (5) shall be disclosed if a health or environmental professional employed by a Federal or State agency or a treating physician or nurse in a nonemergency situation provides a written statement of need and agrees to sign a written confidentiality agreement with the Administrator, subject to the conditions that— (A) the statement of need and confidentiality agreement are consistent with the guidance issued under subsection (d)(3)(B); (B) the written statement of need shall be a statement that the person has a reasonable basis to suspect that— (i) the information is necessary for, or will assist in— (I) the diagnosis or treatment of 1 or more individuals; or (II) responding to an environmental release or exposure; and (ii) 1 or more individuals being diagnosed or treated have been exposed to the chemical substance concerned, or an environmental release or exposure has occurred; and (C) the confidentiality agreement shall provide that the person will not use the information for any purpose other than the health or environmental needs asserted in the statement of need, except as otherwise may be authorized by the terms of the agreement or by the person submitting the information to the Administrator, except that nothing in this Act prohibits the disclosure of any such information through discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law; (6) shall be disclosed if in the event of an emergency, a treating physician, nurse, agent of a poison control center, public health or environmental official of a State or political subdivision of a State, or first responder (including any individual duly authorized by a Federal agency, State, or political subdivision of a State who is trained in urgent medical care or other emergency procedures, including a police officer, firefighter, or emergency medical technician) requests the information, subject to the conditions that— (A) the treating physician, nurse, agent, public health or environmental official of a State or a political subdivision of a State, or first responder shall have a reasonable basis to suspect that— (i) a medical or public health or environmental emergency exists; (ii) the information is necessary for, or will assist in, emergency or first-aid diagnosis or treatment; or (iii) 1 or more individuals being diagnosed or treated have likely been exposed to the chemical substance concerned, or a serious environmental release of or exposure to the chemical substance concerned has occurred; (B) if requested by the person submitting the information to the Administrator, the treating physician, nurse, agent, public health or environmental official of a State or a political subdivision of a State, or first responder shall, as described in paragraph (5)— (i) provide a written statement of need; and (ii) agree to sign a confidentiality agreement; and (C) the written confidentiality agreement or statement of need shall be submitted as soon as practicable, but not necessarily before the information is disclosed; (7) may be disclosed if the Administrator determines that disclosure is relevant in a proceeding under this Act, subject to the condition that the disclosure shall be made in such a manner as to preserve confidentiality to the maximum extent practicable without impairing the proceeding; (8) shall be disclosed if the information is to be disclosed, on written request of any duly authorized congressional committee, to that committee; or (9) shall be disclosed if the information is required to be disclosed or otherwise made public under any other provision of Federal law. (f) Duration of protection from disclosure (1) In general (A) Information not subject to time limit for protection from disclosure Subject to paragraph (2), the Administrator shall protect from disclosure information described in subsection (b) that meets the requirements of subsections (a) and (d), unless— (i) the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall promptly make the information available to the public; or (ii) the Administrator otherwise becomes aware that the information does not qualify or no longer qualifies for protection against disclosure under subsection (a), in which case the Administrator shall take any actions required under subsection (g)(2). (B) Information subject to time limit for protection from disclosure Subject to paragraph (2), the Administrator shall protect from disclosure information, other than information described in subsection (b), that meets the requirements of subsections (a) and (d) for a period of 10 years, unless, prior to the expiration of the period— (i) the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall promptly make the information available to the public; or (ii) the Administrator otherwise becomes aware that the information does not qualify or no longer qualifies for protection against disclosure under subsection (a), in which case the Administrator shall take any actions required under subsection (g)(2). (C) Extensions (i) In general Not later than the date that is 60 days before the expiration of the period described in subparagraph (B), the Administrator shall provide to the person that asserted the claim a notice of the impending expiration of the period. (ii) Statement (I) In general Not later than the date that is 30 days before the expiration of the period described in subparagraph (B), a person reasserting the relevant claim shall submit to the Administrator a request for extension substantiating, in accordance with subsection (d)(2), the need to extend the period. (II) Action by Administrator Not later than the date of expiration of the period described in subparagraph (B), the Administrator shall, in accordance with subsection (g)(1)(C)— (aa) review the request submitted under subclause (I); (bb) make a determination regarding whether the claim for which the request was submitted continues to meet the relevant criteria established under this section; and (cc) (AA) grant an extension of 10 years; or (BB) deny the request. (D) No limit on number of extensions There shall be no limit on the number of extensions granted under subparagraph (C), if the Administrator determines that the relevant request under subparagraph (C)(ii)(I)— (i) establishes the need to extend the period; and (ii) meets the requirements established by the Administrator. (2) Review and resubstantiation (A) Discretion of Administrator The Administrator may review, at any time, a claim for protection of information against disclosure under subsection (a) and require any person that has claimed protection for that information, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , to withdraw or reassert and substantiate or resubstantiate the claim in accordance with this section— (i) after the chemical substance is identified as a high-priority substance under section 4A; (ii) for any chemical substance for which the Administrator has made a determination under section 6(c)(1)(C); (iii) for any inactive chemical substance identified under section 8(b)(5); or (iv) in limited circumstances, if the Administrator determines that disclosure of certain information currently protected from disclosure would assist the Administrator in conducting safety assessments and safety determinations under subsections (b) and (c) of section 6 or promulgating rules pursuant to section 6(d). (B) Review required The Administrator shall review a claim for protection of information against disclosure under subsection (a) and require any person that has claimed protection for that information, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , to withdraw or reassert and substantiate or resubstantiate the claim in accordance with this section— (i) as necessary to determine whether the information qualifies for an exemption from disclosure in connection with a request for information received by the Administrator under section 552 of title 5, United States Code; (ii) if the Administrator has a reasonable basis to believe that the information does not qualify for protection against disclosure under subsection (a); or (iii) for any substance for which the Administrator has made a determination under section 6(c)(1)(B). (C) Action by recipient If the Administrator makes a request under subparagraph (A) or (B), the recipient of the request shall— (i) reassert and substantiate or resubstantiate the claim; or (ii) withdraw the claim. (D) Period of protection Protection from disclosure of information subject to a claim that is reviewed and approved by the Administrator under this paragraph shall be extended for a period of 10 years from the date of approval, subject to any subsequent request by the Administrator under this paragraph. (3) Unique identifier The Administrator shall— (A) (i) develop a system to assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure, other than a specific chemical identity or structurally descriptive generic term; and (ii) apply that identifier consistently to all information relevant to the applicable chemical substance; (B) annually publish and update a list of chemical substances, referred to by unique identifier, for which claims to protect the specific chemical identity from disclosure have been approved, including the expiration date for each such claim; (C) ensure that any nonconfidential information received by the Administrator with respect to such a chemical substance during the period of protection from disclosure— (i) is made public; and (ii) identifies the chemical substance using the unique identifier; and (D) for each claim for protection of specific chemical identity that has been denied by the Administrator or expired, or that has been withdrawn by the submitter, provide public access to the specific chemical identity clearly linked to all nonconfidential information received by the Administrator with respect to the chemical substance. (g) Duties of Administrator (1) Determination (A) In general Except as provided in subsection (b), the Administrator shall, subject to subparagraph (C), not later than 90 days after the receipt of a claim under subsection (d), and not later than 30 days after the receipt of a request for extension of a claim under subsection (f), review and approve, modify, or deny the claim or request. (B) Reasons for denial or modification If the Administrator denies or modifies a claim or request under subparagraph (A), the Administrator shall provide to the person that submitted the claim or request a written statement of the reasons for the denial or modification of the claim or request. (C) Subsets The Administrator shall— (i) except for claims described in subsection (b)(8), review all claims or requests under this section for the protection against disclosure of the specific identity of a chemical substance; and (ii) review a representative subset, comprising at least 25 percent, of all other claims or requests for protection against disclosure. (D) Effect of failure to act The failure of the Administrator to make a decision regarding a claim or request for protection against disclosure or extension under this section shall not be the basis for denial or elimination of a claim or request for protection against disclosure. (2) Notification (A) In general Except as provided in subparagraph (B) and subsections (c), (e), and (f), if the Administrator denies or modifies a claim or request under paragraph (1), intends to release information pursuant to subsection (e), or promulgates a rule under section 6(d) establishing a ban or phase-out of a chemical substance, the Administrator shall notify, in writing and by certified mail, the person that submitted the claim of the intent of the Administrator to release the information. (B) Release of information Except as provided in subparagraph (C), the Administrator shall not release information under this subsection until the date that is 30 days after the date on which the person that submitted the request receives notification under subparagraph (A). (C) Exceptions (i) In general For information under paragraph (3) or (8) of subsection (e), the Administrator shall not release that information until the date that is 15 days after the date on which the person that submitted the claim or request receives a notification, unless the Administrator determines that release of the information is necessary to protect against an imminent and substantial harm to health or the environment, in which case no prior notification shall be necessary. (ii) Notification as soon as practicable For information under paragraphs (4) and (6) of subsection (e), the Administrator shall notify the person that submitted the information that the information has been disclosed as soon as practicable after disclosure of the information. (iii) No notification required Notification shall not be required— (I) for the disclosure of information under paragraph (1), (2), (7), or (9) of subsection (e); or (II) for the disclosure of information for which— (aa) a notice under subsection (f)(1)(C)(i) was received; and (bb) no request was received by the Administrator on or before the date of expiration of the period for which protection from disclosure applies. (3) Rebuttable presumption (A) In general With respect to notifications provided by the Administrator under paragraph (2) with respect to information pertaining to a chemical substance subject to a rule as described in subsection (c)(3), there shall be a rebuttable presumption that the public interest in disclosing confidential information related to a chemical substance subject to a rule promulgated under section 6(d) that establishes a ban or phase-out of the manufacture, processing, or distribution in commerce of the substance outweighs the proprietary interest in maintaining the protection from disclosure of that information. (B) Request for nondisclosure A person that receives a notification under paragraph (2) with respect to the information described in subparagraph (A) may submit to the Administrator, before the date on which the information is to be released pursuant to paragraph (2)(B), a request with supporting documentation describing why the person believes some or all of that information should not be disclosed. (C) Determination by Administrator (i) In general Not later than 30 days after the Administrator receives a request under subparagraph (B), the Administrator shall determine whether the documentation provided by the person making the request rebuts or does not rebut the presumption described in subparagraph (A), for all or a portion of the information that the person has requested not be disclosed. (ii) Objective The Administrator shall make the determination with the objective of ensuring that information relevant to protection of health and the environment is disclosed to the maximum extent practicable. (D) Timing Not later than 30 days after making the determination described in subparagraph (C), the Administrator shall make public the information the Administrator has determined is not to be protected from disclosure. (E) No timely request received If the Administrator does not receive, before the date on which the information described in subparagraph (A) is to be released pursuant to paragraph (2)(B), a request pursuant to subparagraph (B), the Administrator shall promptly make public all of the information. (4) Appeals (A) In general If a person receives a notification under paragraph (2) and believes disclosure of the information is prohibited under subsection (a), before the date on which the information is to be released pursuant to paragraph (2)(B), the person may bring an action to restrain disclosure of the information in— (i) the United States district court of the district in which the complainant resides or has the principal place of business; or (ii) the United States District Court for the District of Columbia. (B) No disclosure The Administrator shall not disclose any information that is the subject of an appeal under this section before the date on which the applicable court rules on an action under subparagraph (A). (5) Request and notification system The Administrator, in consultation with the Director of the Centers for Disease Control and Prevention, shall develop a request and notification system that allows for expedient and swift access to information disclosed pursuant to paragraphs (5) and (6) of subsection (e) in a format and language that is readily accessible and understandable. (h) Criminal penalty for wrongful disclosure (1) Officers and employees of United States (A) In general Subject to paragraph (2), a current or former officer or employee of the United States described in subparagraph (B) shall be guilty of a misdemeanor and fined under title 18, United States Code, or imprisoned for not more than 1 year, or both. (B) Description A current or former officer or employee of the United States referred to in subparagraph (A) is a current or former officer or employee of the United States who— (i) by virtue of that employment or official position has obtained possession of, or has access to, material the disclosure of which is prohibited by subsection (a); and (ii) knowing that disclosure of that material is prohibited by subsection (a), willfully discloses the material in any manner to any person not entitled to receive that material. (2) Other laws Section 1905 of title 18, United States Code, shall not apply with respect to the publishing, divulging, disclosure, making known of, or making available, information reported or otherwise obtained under this Act. (3) Contractors For purposes of this subsection, any contractor of the United States that is provided information in accordance with subsection (e)(2), including any employee of that contractor, shall be considered to be an employee of the United States. (i) Applicability (1) In general Except as otherwise provided in this section, section 8, or any other applicable Federal law, the Administrator shall have no authority— (A) to require the substantiation or resubstantiation of a claim for the protection from disclosure of information reported to or otherwise obtained by the Administrator under this Act before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ; or (B) to impose substantiation or resubstantiation requirements under this Act that are more extensive than those required under this section. (2) Actions prior to promulgation of rules Nothing in this Act prevents the Administrator from reviewing, requiring substantiation or resubstantiation for, or approving, modifying or denying any claim for the protection from disclosure of information before the effective date of such rules applicable to those claims as the Administrator may promulgate after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . . 15. Prohibited acts Section 15 of the Toxic Substances Control Act ( 15 U.S.C. 2614 ) is amended by striking paragraph (1) and inserting the following: (1) fail or refuse to comply with— (A) any rule promulgated, consent agreement entered into, or order issued under section 4; (B) any requirement under section 5 or 6; (C) any rule promulgated, consent agreement entered into, or order issued under section 5 or 6; or (D) any requirement of, or any rule promulgated or order issued pursuant to title II; . 16. Penalties Section 16 of the Toxic Substances Control Act ( 15 U.S.C. 2615 ) is amended— (1) in subsection (a)(1)— (A) in the first sentence, by striking $25,000 and inserting $37,500 ; and (B) in the second sentence, by striking violation of section 15 or 409 and inserting violation of this Act ; and (2) in subsection (b)— (A) by striking Any person who and inserting the following: (1) In general Any person that ; (B) by striking $25,000 and inserting $50,000 ; and (C) by adding at the end the following: (2) Imminent danger of death or serious bodily injury (A) In general Any person that knowingly or willfully violates any provision of section 15 or 409, and that knows at the time of the violation that the violation places an individual in imminent danger of death or serious bodily injury, shall be subject on conviction to a fine of not more than $250,000, or imprisonment for not more than 15 years, or both. (B) Organizations An organization that commits a violation described in subparagraph (A) shall be subject on conviction to a fine of not more than $1,000,000 for each violation. (C) Incorporation of corresponding provisions Subparagraphs (B) through (F) of section 113(c)(5) of the Clean Air Act ( 42 U.S.C. 7413(c)(5) ) shall apply to the prosecution of a violation under this paragraph. . 17. State-Federal relationship Section 18 of the Toxic Substances Control Act ( 15 U.S.C. 2617 ) is amended by striking subsections (a) and (b) and inserting the following: (a) In general (1) Establishment or enforcement Except as provided in subsections (c), (d), (e), (f), and (g), and subject to paragraph (2), no State or political subdivision of a State may establish or continue to enforce any of the following: (A) Testing A statute or administrative action to require the development of information on a chemical substance or category of substances that is reasonably likely to produce the same information required under section 4, 5, or 6 in— (i) a rule promulgated by the Administrator; (ii) a testing consent agreement entered into by the Administrator; or (iii) an order issued by the Administrator. (B) Chemical substances found to meet the safety standard or restricted A statute or administrative action to prohibit or otherwise restrict the manufacture, processing, or distribution in commerce or use of a chemical substance— (i) found to meet the safety standard and consistent with the scope of the determination made under section 6; or (ii) found not to meet the safety standard, after the effective date of the rule issued under section 6(d) for the substance, consistent with the scope of the determination made by the Administrator. (C) Significant new use A statute or administrative action requiring the notification of a use of a chemical substance that the Administrator has specified as a significant new use and for which the Administrator has required notification pursuant to a rule promulgated under section 5. (2) Effective date of preemption Under this subsection, Federal preemption of statutes and administrative actions applicable to specific substances shall not occur until the effective date of the applicable action described in paragraph (1) taken by the Administrator. (b) New statutes or administrative actions creating prohibitions or other restrictions (1) In general Except as provided in subsections (c), (d), (e), (f), and (g), beginning on the date on which the Administrator defines and publishes the scope of a safety assessment and safety determination under section 6(a)(2) and ending on the date on which the deadline established pursuant to section 6(a) for completion of the safety determination expires, or on the date on which the Administrator publishes the safety determination under section 6(a), whichever is earlier, no State or political subdivision of a State may establish a statute or administrative action prohibiting or restricting the manufacture, processing, distribution in commerce or use of a chemical substance that is a high-priority substance designated under section 4A. (2) Effect of subsection (A) In general This subsection does not restrict the authority of a State or political subdivision of a State to continue to enforce any statute enacted, or administrative action taken, prior to the date on which the Administrator defines and publishes the scope of a safety assessment and safety determination under section 6(a)(2). (B) Limitation Subparagraph (A) does not allow a State or political subdivision of a State to enforce any new prohibition or restriction under a statute or administrative action described in that subparagraph, if the prohibition or restriction is established after the date described in that subparagraph. (c) Scope of preemption Federal preemption under subsections (a) and (b) of statutes and administrative actions applicable to specific substances shall apply only to— (1) the chemical substances or category of substances subject to a rule, order, or consent agreement under section 4; (2) the hazards, exposures, risks, and uses or conditions of use of such substances that are identified by the Administrator as subject to review in a safety assessment and included in the scope of the safety determination made by the Administrator for the substance, or of any rule the Administrator promulgates pursuant to section 6(d); or (3) the uses of such substances that the Administrator has specified as significant new uses and for which the Administrator has required notification pursuant to a rule promulgated under section 5. (d) Exceptions (1) No preemption of statutes and administrative actions (A) In general Nothing in this Act, nor any amendment made by this Act, nor any rule, standard of performance, safety determination, or scientific assessment implemented pursuant to this Act, shall affect the right of a State or a political subdivision of a State to adopt or enforce any rule, standard of performance, safety determination, scientific assessment, or any protection for public health or the environment that— (i) is adopted or authorized under the authority of any other Federal law or adopted to satisfy or obtain authorization or approval under any other Federal law; (ii) implements a reporting, monitoring, disclosure, or other information obligation for the chemical substance not otherwise required by the Administrator under this Act or required under any other Federal law; (iii) is adopted pursuant to authority under a law of the State or political subdivision of the State related to water quality, air quality, or waste treatment or disposal, except to the extent that the action— (I) imposes a restriction on the manufacture, processing, distribution in commerce, or use of a chemical substance; and (II) (aa) addresses the same hazards and exposures, with respect to the same conditions of use as are included in the scope of the safety determination pursuant to section 6, but is inconsistent with the action of the Administrator; or (bb) would cause a violation of the applicable action by the Administrator under section 5 or 6; or (iv) subject to subparagraph (B), is identical to a requirement prescribed by the Administrator. (B) Identical requirements (i) In general The penalties and other sanctions applicable under a law of a State or political subdivision of a State in the event of noncompliance with the identical requirement shall be no more stringent than the penalties and other sanctions available to the Administrator under section 16 of this Act. (ii) Penalties In the case of an identical requirement— (I) a State or political subdivision of a State may not assess a penalty for a specific violation for which the Administrator has assessed an adequate penalty under section 16; and (II) if a State or political subdivision of a State has assessed a penalty for a specific violation, the Administrator 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 or political subdivision of a State and the Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16. (2) Applicability to certain rules or orders Notwithstanding subsection (e)— (A) nothing in this section shall be construed as modifying the effect under this section, as in effect on the day before the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , of any rule or order promulgated or issued under this Act prior to that effective date; and (B) with respect to a chemical substance or mixture for which any rule or order was promulgated or issued under section 6 prior to the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with regards to manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance, this section (as in effect on the day before the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ) shall govern the preemptive effect of any rule or order that is promulgated or issued respecting such chemical substance or mixture under section 6 of this Act after that effective date, unless the latter rule or order is with respect to a chemical substance or mixture containing a chemical substance and follows a designation of that chemical substance as a high-priority substance under subsection (b) or (c) of section 4A or as an additional priority for safety assessment and safety determination under section 4A(c). (e) Preservation of certain laws (1) In general Nothing in this Act, subject to subsection (g) of this section, shall— (A) be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken before August 1, 2015, under the authority of a law of the State or political subdivision of the State that prohibits or otherwise restricts manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or (B) be construed to preempt or otherwise affect any action taken pursuant to a State law that was in effect on August 31, 2003. (2) Effect of subsection This subsection does not affect, modify, or alter the relationship between Federal law and laws of a State or political subdivision of a State pursuant to any other Federal law. (f) Waivers (1) Discretionary exemptions Upon application of a State or political subdivision of a State, the Administrator may by rule, exempt from subsection (a), under such conditions as may be prescribed in the rule, a statute or administrative action of that State or political subdivision of the State that relates to the effects of, or exposure to, a chemical substance under the conditions of use if the Administrator determines that— (A) compelling conditions warrant granting the waiver to protect health or the environment; (B) compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; (C) compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and (D) in the judgment of the Administrator, the proposed requirement of the State or political subdivision of the State is designed to address a risk of a chemical substance, under the conditions of use, that was identified— (i) consistent with the best available science; (ii) using supporting studies conducted in accordance with sound and objective scientific practices; and (iii) based on the weight of the scientific evidence. (2) Required exemptions Upon application of a State or political subdivision of a State, the Administrator shall exempt from subsection (b) a statute or administrative action of a State or political subdivision of a State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that— (A) compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; (B) compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and (C) the State or political subdivision of the State has a concern about the chemical substance or use of the chemical substance based in peer-reviewed science. (3) Determination of a waiver request The duty of the Administrator to grant or deny a waiver application shall be nondelegable and shall be exercised— (A) not later than 180 days after the date on which an application under paragraph (1) is submitted; and (B) not later than 110 days after the date on which an application under paragraph (2) is submitted. (4) Failure to make determination If the Administrator fails to make a determination under paragraph (3)(B) during the 110-day period beginning on the date on which an application under paragraph (2) is submitted, the statute or administrative action of the State or political subdivision of the State that was the subject of the application shall not be considered to be an existing statute or administrative action for purposes of subsection (b) by reason of the failure of the Administrator to make a determination. (5) Notice and comment Except in the case of an application approved under paragraph (9), the application of a State or political subdivision of a State shall be subject to public notice and comment. (6) Final agency action The decision of the Administrator on the application of a State or political subdivision of a State shall be— (A) considered to be a final agency action; and (B) subject to judicial review. (7) Duration of waivers A waiver granted under paragraph (2) or approved under paragraph (9) shall remain in effect until such time as the Administrator publishes the safety determination under section 6(a)(4). (8) Judicial review of waivers Not later than 60 days after the date on which the Administrator makes a determination on an application of a State or political subdivision of a State under paragraph (1) or (2), any person may file a petition for judicial review in the United States Court of Appeals for the District of Columbia Circuit, which shall have exclusive jurisdiction over the determination. (9) Approval (A) Automatic approval If the Administrator fails to meet the deadline established under paragraph (3)(B), the application of a State or political subdivision of a State under paragraph (2) shall be automatically approved, effective on the date that is 10 days after the deadline. (B) Requirements Notwithstanding paragraph (6), approval of a waiver application under subparagraph (A) for failure to meet the deadline under paragraph (3)(B) shall not be considered final agency action or be subject to judicial review or public notice and comment. (g) Savings (1) No preemption of common law or statutory causes of action for civil relief or criminal conduct (A) In general Nothing in this Act, nor any amendment made by this Act, nor any safety standard, rule, requirement, standard of performance, safety determination, or scientific assessment implemented pursuant to this Act, shall be construed to preempt, displace, or supplant any state or Federal common law rights or any state or Federal statute creating a remedy for civil relief, including those for civil damage, or a penalty for a criminal conduct. (B) Clarification of no preemption Notwithstanding any other provision of this Act, nothing in this Act, nor any amendments made by this Act, shall preempt or preclude any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory of liability under any State law, maritime law, or Federal common law or statutory theory. (2) No effect on private remedies (A) In general Nothing in this Act, nor any amendments made by this Act, nor any rules, regulations, requirements, safety assessments, safety determinations, scientific assessments, or orders issued pursuant to this Act shall be interpreted as, in either the plaintiff’s or defendant’s favor, dispositive in any civil action. (B) Authority of courts This Act does not affect the authority of any court to make a determination in an adjudicatory proceeding under applicable State or Federal law with respect to the admission into evidence or any other use of this Act or rules, regulations, requirements, standards of performance, safety assessments, scientific assessments, or orders issued pursuant to this Act. . 18. Judicial review Section 19 of the Toxic Substances Control Act ( 15 U.S.C. 2618 ) is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) in the first sentence— (aa) by striking Not and inserting Except as otherwise provided in this title, not ; (bb) by striking section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under title II or IV and inserting this title or title II or IV, or an order under section 6(c)(1)(A) ; and (cc) by striking judicial review of such rule and inserting judicial review of such rule or order ; and (II) in the second sentence, by striking such a rule and inserting such a rule or order ; and (ii) in subparagraph (B)— (I) by striking Courts and inserting Except as otherwise provided in this title, courts ; and (II) by striking an order issued under subparagraph (A) or (B) of section 6(b)(1) and inserting an order issued under this title ; (B) in paragraph (2), in the second sentence, by striking the filing of the rulemaking record of proceedings on which the Administrator based the rule being reviewed and inserting the filing of the record of proceedings on which the Administrator based the rule or order being reviewed ; and (C) by striking paragraph (3) and inserting the following: (3) Judicial review of low-priority decisions (A) In general Not later than 60 days after the publication of a designation under section 4A(b)(4), or a designation under section 4A(b)(8) of a chemical substance as a low-priority substance, any person may commence a civil action to challenge the designation. (B) Jurisdiction The United States Court of Appeals for the District of Columbia Circuit shall have exclusive jurisdiction over a civil action filed under this paragraph. ; and (2) in subsection (c)(1)(B)— (A) in clause (i)— (i) by striking section 4(a), 5(b)(4), 6(a), or 6(e) and inserting section 4(a), 6(d), or 6(g), or an order under section 6(c)(1)(A) ; and (ii) by striking evidence in the rulemaking record (as defined in subsection (a)(3)) taken as a whole; and inserting evidence (including any matter) in the rulemaking record, taken as a whole; and ; and (B) by striking clauses (ii) and (iii) and the matter following clause (iii) and inserting the following: (ii) the court may not review the contents and adequacy of any statement of basis and purpose required by section 553(c) of title 5, United States Code, to be incorporated in the rule, except as part of the rulemaking record, taken as a whole. . 19. Citizens' civil actions Section 20 of the Toxic Substances Control Act ( 15 U.S.C. 2619 ) is amended— (1) in subsection (a)(1), by striking or order issued under section 5 and inserting or order issued under section 4 or 5 ; and (2) in subsection (b)— (A) in paragraph (1)(B), by striking or at the end; (B) in paragraph (2), by striking the period at the end and inserting , except that no prior notification shall be required in the case of a civil action brought to compel a decision by the Administrator pursuant to section 18(f)(3)(B); or ; and (C) by adding at the end the following: (3) in the case of a civil action brought to compel a decision by the Administrator pursuant to section 18(f)(3)(B), after the date that is 60 days after the deadline specified in section 18(f)(3)(B). . 20. Citizens' petitions Section 21 of the Toxic Substances Control Act ( 15 U.S.C. 2620 ) is amended— (1) in subsection (a), by striking an order under section 5(e) or 6(b)(2) and inserting an order under section 4 or 5(d) ; and (2) in subsection (b)— (A) in paragraph (1), by striking an order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B) and inserting an order under section 4 or 5(d) ; and (B) in paragraph (4), by striking subparagraph (B) and inserting the following: (B) De novo proceeding (i) In general In an action under subparagraph (A) to initiate a proceeding to issue a rule pursuant to section 4, 5, 6, or 8 or issue an order under section 4 or 5(d), the petitioner shall be provided an opportunity to have the petition considered by the court in a de novo proceeding. (ii) Demonstration (I) In general The court in a de novo proceeding under this subparagraph shall order the Administrator to initiate the action requested by the petitioner if the petitioner demonstrates to the satisfaction of the court by a preponderance of the evidence that— (aa) in the case of a petition to initiate a proceeding for the issuance of a rule or order under section 4, the information is needed for a purpose identified in section 4(a); (bb) in the case of a petition to issue an order under section 5(d), the chemical substance is not likely to meet the safety standard; (cc) in the case of a petition to initiate a proceeding for the issuance of a rule under section 6(d), the chemical substance does not meet the safety standard; or (dd) in the case of a petition to initiate a proceeding for the issuance of a rule under section 8, there is a reasonable basis to conclude that the rule is necessary to protect health or the environment or ensure that the chemical substance meets the safety standard. (II) Deferment The court in a de novo proceeding under this subparagraph may permit the Administrator to defer initiating the action requested by the petitioner until such time as the court prescribes, if the court finds that— (aa) the extent of the risk to health or the environment alleged by the petitioner is less than the extent of risks to health or the environment with respect to which the Administrator is taking action under this Act; and (bb) there are insufficient resources available to the Administrator to take the action requested by the petitioner. . 21. Employment effects Section 24(b)(2)(B)(ii) of the Toxic Substances Control Act ( 15 U.S.C. 2623(b)(2)(B)(ii) ) is amended by striking section 6(c)(3), and inserting the applicable requirements of this Act; . 22. Studies Section 25 of the Toxic Substances Control Act ( 15 U.S.C. 2624 ) is repealed. 23. Administration Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) by striking subsection (b) and inserting the following: (b) Fees (1) In general The Administrator shall establish, not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , by rule— (A) the payment of 1 or more reasonable fees as a condition of submitting a notice or requesting an exemption under section 5; and (B) the payment of 1 or more reasonable fees by a manufacturer or processor that— (i) is required to submit a notice pursuant to the rule promulgated under section 8(b)(4)(A)(i) identifying a chemical substance as active; (ii) is required to submit a notice pursuant to section 8(b)(5)(B)(i) changing the status of a chemical substance from inactive to active; (iii) is required to report information pursuant to the rules promulgated under paragraph (1) or (4) of section 8(a); or (iv) manufactures or processes a chemical substance subject to a safety assessment and safety determination pursuant to section 6. (2) Utilization and collection of fees The Administrator shall— (A) utilize the fees collected under paragraph (1) only to defray costs associated with the actions of the Administrator— (i) to collect, process, review, provide access to, and protect from disclosure (where appropriate) information on chemical substances under this Act; (ii) to review notices and make determinations for chemical substances under paragraphs (1) and (3) of section 5(d) and impose any necessary restrictions under section 5(d)(4); (iii) to make prioritization decisions under section 4A; (iv) to conduct and complete safety assessments and determinations under section 6; and (v) to conduct any necessary rulemaking pursuant to section 6(d); (B) insofar as possible, collect the fees described in paragraph (1) in advance of conducting any fee-supported activity; (C) deposit the fees in the Fund established by paragraph (4)(A); and (D) insofar as possible, not collect excess fees or retain a significant amount of unused fees. (3) Amount and adjustment of fees; refunds In setting fees under this section, the Administrator shall— (A) prescribe lower fees for small business concerns, after consultation with the Administrator of the Small Business Administration; (B) set the fees established under paragraph (1) at levels such that the fees will, in aggregate, provide a sustainable source of funds to annually defray— (i) the lower of— (I) 25 percent of the costs of conducting the activities identified in paragraph (2)(A), other than the costs to conduct and complete safety assessments and determinations under section 6 for chemical substances identified pursuant to section 4A(c); or (II) $25,000,000 (subject to adjustment pursuant to subparagraph (F)); and (ii) the full costs and the 50-percent portion of the costs of safety assessments and safety determinations specified in subparagraph (D); (C) reflect an appropriate balance in the assessment of fees between manufacturers and processors, and allow the payment of fees by consortia of manufacturers or processors; (D) notwithstanding subparagraph (B) and paragraph (4)(D)— (i) for substances designated pursuant to section 4A(c)(1), establish the fee at a level sufficient to defray the full annual costs to the Administrator of conducting the safety assessment and safety determination under section 6; and (ii) for substances designated pursuant to section 4A(c)(3), establish the fee at a level sufficient to defray 50 percent of the annual costs to the Administrator of conducting the safety assessment and safety determination under section 6; (E) prior to the establishment or amendment of any fees under paragraph (1), consult and meet with parties potentially subject to the fees or their representatives, subject to the condition that no obligation under the Federal Advisory Committee Act (5 U.S.C. App.) or subchapter III of chapter 5 of title 5, United States Code, is applicable with respect to such meetings; (F) beginning with the fiscal year that is 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and every 3 years thereafter, after consultation with parties potentially subject to the fees and their representatives pursuant to subparagraph (E), increase or decrease the fees established under paragraph (1) as necessary to adjust for inflation and to ensure, based on the audit analysis required under paragraph (5)(B), that funds deposited in the Fund are sufficient to defray— (i) approximately but not more than 25 percent of the annual costs to conduct the activities identified in paragraph (2)(A), other than the costs to conduct and complete safety assessments and determinations under section 6 for chemical substances identified pursuant to section 4A(c); and (ii) the full annual costs and the 50-percent portion of the annual costs of safety assessments and safety determinations specified in subparagraph (D); (G) adjust fees established under paragraph (1) as necessary to vary on account of differing circumstances, including reduced fees or waivers in appropriate circumstances, to reduce the burden on manufacturing or processing, remove barriers to innovation, or where the costs to the Administrator of collecting the fees exceed the fee revenue anticipated to be collected; and (H) if a notice submitted under section 5 is refused or subsequently withdrawn, refund the fee or a portion of the fee if no substantial work was performed on the notice. (4) TSCA Implementation Fund (A) Establishment There is established in the Treasury of the United States a fund, to be known as the TSCA Implementation Fund (referred to in this subsection as the Fund ), consisting of— (i) such amounts as are deposited in the Fund under paragraph (2)(C); and (ii) any interest earned on the investment of amounts in the Fund; and (iii) any proceeds from the sale or redemption of investments held in the Fund. (B) Crediting and availability of fees (i) In general Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation. (ii) Requirements Fees collected under this section shall not— (I) be made available or obligated for any purpose other than to defray the costs of conducting the activities identified in paragraph (2)(A); (II) otherwise be available for any purpose other than implementation of this Act; and (III) so long as amounts in the Fund remain available, be subject to restrictions on expenditures applicable to the Federal government as a whole. (C) Unused funds Amounts in the Fund not currently needed to carry out this subsection shall be— (i) maintained readily available or on deposit; (ii) invested in obligations of the United States or guaranteed by the United States; or (iii) invested in obligations, participations, or other instruments that are lawful investments for fiduciary, trust, or public funds. (D) Minimum amount of appropriations Fees may not be assessed for a fiscal year under this section unless the amount of appropriations for the Chemical Risk Review and Reduction program project of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for that program project for fiscal year 2014. (5) Auditing (A) Financial statements of agencies For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of an executive agency. (B) Components The annual audit required under sections 3515(b) and 3521 of that title of the financial statements of activities under this subsection shall include an analysis of— (i) the fees collected under paragraph (1) and disbursed; (ii) compliance with the deadlines established in section 6 of this Act; (iii) the amounts budgeted, appropriated, collected from fees, and disbursed to meet the requirements of sections 4, 4A, 5, 6, 8, and 14, including the allocation of full time equivalent employees to each such section or activity; and (iv) the reasonableness of the allocation of the overhead associated with the conduct of the activities described in paragraph (2)(A). (C) Inspector General The Inspector General of the Environmental Protection Agency shall— (i) conduct the annual audit required under this subsection; and (ii) report the findings and recommendations of the audit to the Administrator and to the appropriate committees of Congress. (6) Termination The authority provided by this section shall terminate at the conclusion of the fiscal year that is 10 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , unless otherwise reauthorized or modified by Congress. ; (2) in subsection (e), by striking Health, Education, and Welfare each place it appears and inserting Health and Human Services ; and (3) adding at the end the following: (h) Prior actions Nothing in this Act eliminates, modifies, or withdraws any rule promulgated, order issued, or exemption established pursuant to this Act before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . . 24. Development and evaluation of test methods and sustainable chemistry (a) In general Section 27 of the Toxic Substances Control Act ( 15 U.S.C. 2626 ) is amended— (1) in subsection (a), in the first sentence by striking Health, Education, and Welfare and inserting Health and Human Services ; and (2) by adding at the end the following: (c) National coordinating entity for sustainable chemistry (1) Establishment Not later than 180 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Director of the Office of Science and Technology Policy shall convene an entity under the National Science and Technology Council with the responsibility to coordinate Federal programs and activities in support of sustainable chemistry, including, as appropriate, at the National Science Foundation, the Department of Energy, the Department of Agriculture, the Environmental Protection Agency, the National Institute of Standards and Technology, the Department of Defense, the National Institutes of Health, and other related Federal agencies. (2) Chairman The entity described in paragraph (1) shall be chaired by the Director of the National Science Foundation and the Assistant Administrator for the Office of Research and Development of the Environmental Protection Agency, or their designees. (3) Duties (A) In general The entity described in paragraph (1) shall— (i) develop a working definition of sustainable chemistry, after seeking advice and input from stakeholders as described in clause (v); (ii) oversee the planning, management, and coordination of the Sustainable Chemistry Initiative described in subsection (d); (iii) develop a national strategy for sustainable chemistry as described in subsection (f); (iv) develop an implementation plan for sustainable chemistry as described in subsection (g); and (v) consult and coordinate with stakeholders qualified to provide advice and information on the development of the initiative, national strategy, and implementation plan for sustainable chemistry, at least once per year, to carry out activities that may include workshops, requests for information, and other efforts as necessary. (B) Stakeholders The stakeholders described in subparagraph (A)(v) shall include representatives from— (i) industry (including small- and medium-sized enterprises from across the value chain); (ii) the scientific community (including the National Academy of Sciences, scientific professional societies, and academia); (iii) the defense community; (iv) State, tribal, and local governments; (v) State or regional sustainable chemistry programs; (vi) nongovernmental organizations; and (vii) other appropriate organizations. (4) Sunset (A) In general On completion of the national strategy and accompanying implementation plan for sustainable chemistry as described in paragraph (3), the Director of the Office of Science and Technology Policy— (i) shall review the need for further work; and (ii) may disband the entity described in paragraph (1) if no further efforts are determined to be necessary. (B) Notice and justification The Director of the Office of Science and Technology Policy shall provide notice and justification, including an analysis of options to establish the Sustainable Chemistry Initiative described in subsection (d) and the partnerships described in subsection (e) within 1 or more appropriate Federal agencies, regarding a decision to disband the entity not less than 90 days prior to the termination date to the Committee on Science, Space, and Technology and the Committee on Energy and Commerce of the House of Representatives and the Committee on Environment and Public Works and the Committee on Commerce, Science, and Transportation of the Senate. (d) Sustainable Chemistry Initiative The entity described in subsection (c)(1) shall oversee the establishment of an interagency Sustainable Chemistry Initiative to promote and coordinate activities designed— (1) to provide sustained support for sustainable chemistry research, development, demonstration, technology transfer, commercialization, education, and training through— (A) coordination and promotion of sustainable chemistry research, development, demonstration, and technology transfer conducted at Federal and national laboratories and Federal agencies and at public and private institutions of higher education; and (B) to the extent practicable, encouragement of consideration of sustainable chemistry in, as appropriate— (i) the conduct of Federal, State, and private science and engineering research and development; and (ii) the solicitation and evaluation of applicable proposals for science and engineering research and development; (2) to examine methods by which the Federal Government can offer incentives for consideration and use of sustainable chemistry processes and products that encourage competition and overcoming market barriers, including grants, loans, loan guarantees, and innovative financing mechanisms; (3) to expand the education and training of undergraduate and graduate students and professional scientists and engineers, including through partnerships with industry as described in subsection (e), in sustainable chemistry science and engineering; (4) to collect and disseminate information on sustainable chemistry research, development, and technology transfer, including information on— (A) incentives and impediments to development, manufacturing, and commercialization; (B) accomplishments; (C) best practices; and (D) costs and benefits; and (5) to support (including through technical assistance, participation, financial support, or other forms of support) economic, legal, and other appropriate social science research to identify barriers to commercialization and methods to advance commercialization of sustainable chemistry. (e) Partnerships in sustainable chemistry (1) In general The entity described in subsection (c)(1), itself or through an appropriate subgroup designated or established by the entity, shall work through the agencies described in subsection (c)(1) to support, through financial, technical, or other assistance, the establishment of partnerships between institutions of higher education, nongovernmental organizations, consortia, and companies across the value chain in the chemical industry, including small- and medium-sized enterprises— (A) to establish collaborative research, development, demonstration, technology transfer, and commercialization programs; and (B) to train students and retrain professional scientists and engineers in the use of sustainable chemistry concepts and strategies by methods including— (i) developing curricular materials and courses for undergraduate and graduate levels and for the professional development of scientists and engineers; and (ii) publicizing the availability of professional development courses in sustainable chemistry and recruiting scientists and engineers to pursue those courses. (2) Private sector entities To be eligible for support under this section, a partnership in sustainable chemistry shall include at least 1 private sector entity. (3) Selection of partnerships In selecting partnerships for support under this section, the entity and the agencies described in subsection (c)(1) shall also consider the extent to which the applicants are willing and able to demonstrate evidence of support for, and commitment— (A) to achieving the goals of the Sustainable Chemistry Initiative described in subsection (d); and (B) to sustaining any new innovations, tools, and resources generated from funding under the program. (4) Prohibited use of funds Financial support provided under this section may not be used— (A) to support or expand a regulatory chemical management program at an implementing agency under a State law; or (B) to construct or renovate a building or structure. (f) National strategy to Congress (1) In general Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the entity described in subsection (c)(1) shall submit to the Committee on Science, Space, and Technology and the Committee on Energy and Commerce of the House of Representatives and the Committee on Environment and Public Works and the Committee on Commerce, Science, and Transportation of the Senate, a national strategy that shall include— (A) a summary of federally funded sustainable chemistry research, development, demonstration, technology transfer, commercialization, education, and training activities; (B) a summary of the financial resources allocated to sustainable chemistry initiatives; (C) an analysis of the progress made toward achieving the goals and priorities of the Sustainable Chemistry Initiative described in subsection (d), and recommendations for future initiative activities, including consideration of options to establish the Sustainable Chemistry Initiative and the partnerships described in subsection (e) within 1 or more appropriate Federal agencies; (D) an assessment of the benefits of expanding existing, federally supported regional innovation and manufacturing hubs to include sustainable chemistry and the value of directing the establishment of 1 or more dedicated sustainable chemistry centers of excellence or hubs; (E) an evaluation of steps taken and future strategies to avoid duplication of efforts, streamline interagency coordination, facilitate information sharing, and spread best practices between participating agencies in the Sustainable Chemistry Initiative; and (F) a framework for advancing sustainable chemistry research, development, technology transfer, commercialization, and education and training. (2) Submission to GAO The entity described in subsection (c)(1) shall submit the national strategy described in paragraph (1) to the Government Accountability Office for consideration in future Congressional inquiries. (g) Implementation plan Not later than 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the entity described in subsection (c)(1) shall submit to the Committee on Science, Space, and Technology and the Committee on Energy and Commerce of the House of Representatives and the Committee on Environment and Public Works and the Committee on Commerce, Science, and Transportation of the Senate, an implementation plan, based on the findings of the national strategy and other assessments, as appropriate, for sustainable chemistry. . (b) Sustainable chemistry basic research Subject to the availability of appropriated funds, the Director of the National Science Foundation shall continue to carry out the Green Chemistry Basic Research program authorized under section 509 of the National Science Foundation Authorization Act of 2010 ( 42 U.S.C. 1862p–3 ). 25. State programs Section 28 of the Toxic Substances Control Act ( 15 U.S.C. 2627 ) is amended— (1) in subsection (b)(1)— (A) in subparagraphs (A) through (D), by striking the comma at the end of each subparagraph and inserting a semicolon; and (B) in subparagraph (E), by striking , and and inserting ; and ; and (2) by striking subsections (c) and (d). 26. Authorization of appropriations Section 29 of the Toxic Substances Control Act ( 15 U.S.C. 2628 ) is repealed. 27. Annual report Section 30 of the Toxic Substances Control Act ( 15 U.S.C. 2629 ) is amended by striking paragraph (2) and inserting the following: (2) (A) the number of notices received during each year under section 5; and (B) the number of the notices described in subparagraph (A) for chemical substances subject to a rule, testing consent agreement, or order under section 4; . 28. Effective date Section 31 of the Toxic Substances Control Act ( 15 U.S.C. 2601 note; Public Law 94–469 ) is amended— (1) by striking Except as provided in section 4(f), this and inserting the following: (a) In general This ; and (2) by adding at the end the following: (b) Retroactive applicability Nothing in this Act shall be interpreted to apply retroactively to any State, Federal, or maritime legal action commenced prior to the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . . 29. Elemental mercury (a) Temporary generator accumulation Section 5 of the Mercury Export Ban Act of 2008 ( 42 U.S.C. 6939f ) is amended— (1) in subsection (a)(2), by striking 2013 and inserting 2019 ; (2) in subsection (b)— (A) in paragraph (1)— (i) by redesignating subparagraphs (A), (B), and (C), as clauses (i), (ii), and (iii), respectively and indenting appropriately; (ii) in the first sentence, by striking After consultation and inserting the following: (A) Assessment and collection After consultation ; (iii) in the second sentence, by striking The amount of such fees and inserting the following: (B) Amount The amount of the fees described in subparagraph (A) ; (iv) in subparagraph (B) (as so designated)— (I) in clause (i) (as so redesignated), by striking publically available not later than October 1, 2012 and inserting publicly available not later than October 1, 2018 ; (II) in clause (ii) (as so redesignated), by striking and ; (III) in clause (iii) (as so redesignated), by striking the period at the end and inserting , subject to clause (iv); and ; and (IV) by adding at the end the following: (iv) for generators temporarily accumulating elemental mercury in a facility subject to subparagraphs (B) and (D)(iv) of subsection (g)(2) if the facility designated in subsection (a) is not operational by January 1, 2019, shall be adjusted to subtract the cost of the temporary accumulation during the period in which the facility designated under subsection (a) is not operational. ; and (v) by adding at the end the following: (C) Conveyance of title and permitting If the facility designated in subsection (a) is not operational by January 1, 2020, the Secretary— (i) shall immediately accept the conveyance of title to all elemental mercury that has accumulated in facilities in accordance with subsection (g)(2)(D), before January 1, 2020, and deliver the accumulated mercury to the facility designated under subsection (a) on the date on which the facility becomes operational; (ii) shall pay any applicable Federal permitting costs, including the costs for permits issued under section 3005(c) of the Solid Waste Disposal Act ( 42 U.S.C. 6925(c) ); and (iii) shall store, or pay the cost of storage of, until the time at which a facility designated in subsection (a) is operational, accumulated mercury to which the Secretary has title under this subparagraph in a facility that has been issued a permit under section 3005(c) of the Solid Waste Disposal Act ( 42 U.S.C. 6925(c) ). ; and (B) in paragraph (2), in the first sentence, by striking paragraph (1)(C) and inserting paragraph (1)(B)(iii) ; and (3) in subsection (g)(2)— (A) in the undesignated material at the end, by striking This subparagraph and inserting the following: (C) Subparagraph (B) ; (B) in subparagraph (C) (as added by paragraph (1)), by inserting of that subparagraph before the period at the end; and (C) by adding at the end the following: (D) A generator producing elemental mercury incidentally from the beneficiation or processing of ore or related pollution control activities, may accumulate the mercury produced onsite that is destined for a facility designated by the Secretary under subsection (a), for more than 90 days without a permit issued under section 3005(c) of the Solid Waste Disposal Act ( 42 U.S.C. 6925(c) ), and shall not be subject to the storage prohibition of section 3004(j) of that Act ( 42 U.S.C. 6924(j) ), if— (i) the Secretary is unable to accept the mercury at a facility designated by the Secretary under subsection (a) for reasons beyond the control of the generator; (ii) the generator certifies in writing to the Secretary that the generator will ship the mercury to a designated facility when the Secretary is able to accept the mercury; (iii) the generator certifies in writing to the Secretary that the generator is storing only mercury the generator has produced or recovered onsite and will not sell, or otherwise place into commerce, the mercury; and (iv) the generator has obtained an identification number under section 262.12 of title 40, Code of Federal Regulations, and complies with the requirements described in paragraphs (1) through (4) of section 262.34(a) of title 40, Code of Federal Regulations (as in effect on the date of enactment of this subparagraph). (E) Management standards for temporary storage Not later than January 1, 2017, the Secretary, after consultation with the Administrator of the Environmental Protection Agency and State agencies in affected States, shall develop and make available guidance that establishes procedures and standards for the management and short-term storage of elemental mercury at a generator covered under subparagraph (D), including requirements to ensure appropriate use of flasks or other suitable containers. Such procedures and standards shall be protective of human health and the environment and shall ensure that the elemental mercury is stored in a safe, secure, and effective manner. A generator may accumulate mercury in accordance with subparagraph (D) immediately upon enactment of this Act, and notwithstanding that guidance called for by this paragraph (E) has not been developed or made available. . (b) Interim status Section 5(d)(1) of the Mercury Export Ban Act of 2008 ( 42 U.S.C. 6939f(d)(1) ) is amended— (1) in the fourth sentence, by striking in existence on or before January 1, 2013, ; and (2) in the last sentence, by striking January 1, 2015 and inserting January 1, 2020 . (c) Mercury inventory Section 8(b) of the Toxic Substances Control Act ( 15 U.S.C. 2607(b) ) (as amended by section 10(2)) is amended by adding at the end the following: (10) Mercury (A) Definition of mercury In this paragraph, notwithstanding section 3(2)(B), the term mercury means— (i) elemental mercury; and (ii) a mercury compound. (B) Publication Not later than April 1, 2017, and every 3 years thereafter, the Administrator shall publish in the Federal Register an inventory of mercury supply, use, and trade in the United States. (C) Process In carrying out the inventory under subparagraph (B), the Administrator shall— (i) identify any remaining manufacturing processes or products that intentionally add mercury; and (ii) recommend actions, including proposed revisions of Federal law (including regulations), to achieve further reductions in mercury use. (D) Reporting (i) In general To assist in the preparation of the inventory under subparagraph (B), any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the Administrator, at such time and including such information as the Administrator shall determine by rule promulgated not later than 2 years after the date of enactment of this paragraph. (ii) Coordination To avoid duplication, the Administrator shall coordinate the reporting under this subparagraph with the Interstate Mercury Education and Reduction Clearinghouse. (iii) Exemption This subparagraph shall not apply to a person engaged in the generation, handling, or management of mercury-containing waste, unless that person manufactures or recovers mercury in the management of that waste. . (d) Prohibition on export of certain mercury compounds Section 12(c) of the Toxic Substances Control Act ( 15 U.S.C. 2611(c) ) (as amended by section 13(3)) is amended— (1) in the subsection heading, by inserting and mercury compounds after mercury ; and (2) by inserting after paragraph (2) the following: (3) Prohibition on export of certain mercury compounds (A) In general Effective January 1, 2020, the export of the following mercury compounds is prohibited: (i) Mercury (I) chloride or calomel. (ii) Mercury (II) oxide. (iii) Mercury (II) sulfate. (iv) Mercury (II) nitrate. (v) Cinnabar or mercury sulphide. (vi) Any mercury compound that the Administrator, at the discretion of the Administrator, adds to the list by rule, on determining that exporting that mercury compound for the purpose of regenerating elemental mercury is technically feasible. (B) Publication Not later than 90 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and as appropriate thereafter, the Administrator shall publish in the Federal Register a list of the mercury compounds that are prohibited from export under this paragraph. (C) Petition Any person may petition the Administrator to add to the list of mercury compounds prohibited from export. (D) Environmentally sound disposal This paragraph does not prohibit the export of mercury (I) chloride or calomel for environmentally sound disposal to member countries of the Organization for Economic Cooperation and Development, on the condition that no mercury or mercury compounds are to be recovered, recycled, or reclaimed for use, or directly reused. (E) Report Not later than 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall evaluate any exports of calomel for disposal that occurred since that date of enactment and shall submit to Congress a report that contains the following: (i) volumes and sources of calomel exported for disposal; (ii) receiving countries of such exports; (iii) methods of disposal used; (iv) issues, if any, presented by the export of calomel; (v) evaluation of calomel management options in the United States, if any, that are commercially available and comparable in cost and efficacy to methods being utilized in the receiving countries; and (vi) a recommendation regarding whether Congress should further limit or prohibit the export of calomel for disposal. (F) Effect on other law Nothing in this paragraph shall be construed to affect the authority of the Administrator under Solid Waste Disposal Act ( 42 U.S.C. 6901 et seq. ). . 30. Trevor's law (a) Purposes The purposes of this section are— (1) to provide the appropriate Federal agencies with the authority to help conduct investigations into potential cancer clusters; (2) to ensure that Federal agencies have the authority to undertake actions to help address cancer clusters and factors that may contribute to the creation of potential cancer clusters; and (3) to enable Federal agencies to coordinate with other Federal, State, and local agencies, institutes of higher education, and the public in investigating and addressing cancer clusters. (b) Designation and investigation of potential cancer clusters Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. ) is amended by adding at the end the following: 399V–6. Designation and investigation of potential cancer clusters (a) Definitions In this section: (1) Cancer cluster The term cancer cluster means the incidence of a particular cancer within a population group, a geographical area, or a period of time that is greater than expected for such group, area, or period. (2) Particular cancer The term particular cancer means one specific type of cancer or a type of cancers scientifically proven to have the same cause. (3) Population group The term population group means a group, for purposes of calculating cancer rates, defined by factors such as race, ethnicity, age, or gender. (b) Criteria for designation of potential cancer clusters (1) Development of criteria The Secretary shall develop criteria for the designation of potential cancer clusters. (2) Requirements The criteria developed under paragraph (1) shall consider, as appropriate— (A) a standard for cancer cluster identification and reporting protocols used to determine when cancer incidence is greater than would be typically observed; (B) scientific screening standards that ensure that a cluster of a particular cancer involves the same type of cancer, or types of cancers; (C) the population in which the cluster of a particular cancer occurs by factors such as race, ethnicity, age, and gender, for purposes of calculating cancer rates; (D) the boundaries of a geographic area in which a cluster of a particular cancer occurs so as not to create or obscure a potential cluster by selection of a specific area; and (E) the time period over which the number of cases of a particular cancer, or the calculation of an expected number of cases, occurs. (c) Guidelines for investigation of potential cancer clusters The Secretary, in consultation with the Council of State and Territorial Epidemiologists and representatives of State and local health departments, shall develop, publish, and periodically update guidelines for investigating potential cancer clusters. The guidelines shall— (1) require that investigations of cancer clusters— (A) use the criteria developed under subsection (b); (B) use the best available science; and (C) rely on a weight of the scientific evidence; (2) provide standardized methods of reviewing and categorizing data, including from health surveillance systems and reports of potential cancer clusters; and (3) provide guidance for using appropriate epidemiological and other approaches for investigations. (d) Investigation of cancer clusters (1) Secretary discretion The Secretary— (A) in consultation with representatives of the relevant State and local health departments, shall consider whether it is appropriate to conduct an investigation of a potential cancer cluster; and (B) in conducting investigations shall have the discretion to prioritize certain potential cancer clusters, based on the availability of resources. (2) Coordination In investigating potential cancer clusters, the Secretary shall coordinate with agencies within the Department of Health and Human Services and other Federal agencies, such as the Environmental Protection Agency. (3) Biomonitoring In investigating potential cancer clusters, the Secretary shall rely on all appropriate biomonitoring information collected under other Federal programs, such as the National Health and Nutrition Examination Survey. The Secretary may provide technical assistance for relevant biomonitoring studies of other Federal agencies. (e) Duties The Secretary shall— (1) ensure that appropriate staff of agencies within the Department of Health and Human Services are prepared to provide timely assistance, to the extent practicable, upon receiving a request to investigate a potential cancer cluster from a State or local health authority; (2) maintain staff expertise in epidemiology, toxicology, data analysis, environmental health and cancer surveillance, exposure assessment, pediatric health, pollution control, community outreach, health education, laboratory sampling and analysis, spatial mapping, and informatics; (3) consult with community members as investigations into potential cancer clusters are conducted, as the Secretary determines appropriate; (4) collect, store, and disseminate reports on investigations of potential cancer clusters, the possible causes of such clusters, and the actions taken to address such clusters; and (5) provide technical assistance for investigating cancer clusters to State and local health departments through existing programs, such as the Epi-Aids program of the Centers for Disease Control and Prevention and the Assessments of Chemical Exposures program of the Agency for Toxic Substances and Disease Registry. .

Secretary

tv_txt: 114th CONGRESS 2d Session In the House of Representatives, U. S., May 24, 2016 HOUSE AMENDMENT TO SENATE AMENDMENT:

That the House agree to the amendment of the Senate to the bill (H.R. 2576) entitled An Act to modernize the Toxic Substances Control Act, and for other purposes. with the following In lieu of the matter proposed to be inserted by the amendment of the Senate, insert the following: 1. Short title; table of contents (a) Short title This Act may be cited as the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—CHEMICAL SAFETY Sec. 2. Findings, policy, and intent. Sec. 3. Definitions. Sec. 4. Testing of chemical substances and mixtures. Sec. 5. Manufacturing and processing notices. Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances and mixtures. Sec. 7. Imminent hazards. Sec. 8. Reporting and retention of information. Sec. 9. Relationship to other Federal laws. Sec. 10. Exports of elemental mercury. Sec. 11. Confidential information. Sec. 12. Penalties. Sec. 13. State-Federal relationship. Sec. 14. Judicial review. Sec. 15. Citizens’ civil actions. Sec. 16. Studies. Sec. 17. Administration of the Act. Sec. 18. State programs. Sec. 19. Conforming amendments. Sec. 20. No retroactivity. Sec. 21. Trevor’s Law. TITLE II—RURAL HEALTHCARE CONNECTIVITY Sec. 201. Short title. Sec. 202. Telecommunications services for skilled nursing facilities. I Chemical Safety 2. Findings, policy, and intent Section 2(c) of the Toxic Substances Control Act ( 15 U.S.C. 2601(c) ) is amended by striking proposes to take and inserting proposes as provided . 3. Definitions Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) by redesignating paragraphs (4) through (14) as paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), (16), and (17), respectively; (2) by inserting after paragraph (3) the following: (4) The term conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. ; (3) by inserting after paragraph (6), as so redesignated, the following: (7) The term guidance means any significant written guidance of general applicability prepared by the Administrator. ; and (4) by inserting after paragraph (11), as so redesignated, the following: (12) The term potentially exposed or susceptible subpopulation means a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly. . 4. Testing of chemical substances and mixtures Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) by striking standards each place it appears and inserting protocols and methodologies ; (2) in subsection (a)— (A) by striking If the Administrator finds and inserting (1) If the Administrator finds ; (B) in paragraph (1), as so designated— (i) by striking (1)(A)(i) and inserting (A)(i)(I) ; (ii) by striking (ii) each place it appears and inserting (II) ; (iii) by striking are insufficient data and inserting is insufficient information each place it appears; (iv) by striking (iii) each place it appears and inserting (III) ; (v) by striking such data and inserting such information each place it appears; (vi) by striking (B)(i) and inserting (ii)(I) ; (vii) by striking (I) and inserting (aa) ; (viii) by striking (II) and inserting (bb) ; (ix) by striking (2) and inserting (B) ; and (x) in the matter following subparagraph (B), as so redesignated— (I) by inserting , or, in the case of a chemical substance or mixture described in subparagraph (A)(i), by rule, order, or consent agreement, after rule ; (II) by striking data each place it appears and inserting information ; and (III) by striking and which are relevant and inserting and which is relevant ; and (C) by adding at the end the following: (2) Additional testing authority In addition to the authority provided under paragraph (1), the Administrator may, by rule, order, or consent agreement— (A) require the development of new information relating to a chemical substance or mixture if the Administrator determines that the information is necessary— (i) to review a notice under section 5 or to perform a risk evaluation under section 6(b); (ii) to implement a requirement imposed in a rule, order, or consent agreement under subsection (e) or (f) of section 5 or in a rule promulgated under section 6(a); (iii) at the request of a Federal implementing authority under another Federal law, to meet the regulatory testing needs of that authority with regard to toxicity and exposure; or (iv) pursuant to section 12(a)(2); and (B) require the development of new information for the purposes of prioritizing a chemical substance under section 6(b) only if the Administrator determines that such information is necessary to establish the priority of the substance, subject to the limitations that— (i) not later than 90 days after the date of receipt of information regarding a chemical substance complying with a rule, order, or consent agreement under this subparagraph, the Administrator shall designate the chemical substance as a high-priority substance or a low-priority substance; and (ii) information required by the Administrator under this subparagraph shall not be required for the purposes of establishing or implementing a minimum information requirement of broader applicability. (3) Statement of need When requiring the development of new information relating to a chemical substance or mixture under paragraph (2), the Administrator shall identify the need for the new information, describe how information reasonably available to the Administrator was used to inform the decision to require new information, explain the basis for any decision that requires the use of vertebrate animals, and, as applicable, explain why issuance of an order is warranted instead of promulgating a rule or entering into a consent agreement. (4) Tiered testing When requiring the development of new information under this subsection, the Administrator shall employ a tiered screening and testing process, under which the results of screening-level tests or assessments of available information inform the decision as to whether 1 or more additional tests are necessary, unless information available to the Administrator justifies more advanced testing of potential health or environmental effects or potential exposure without first conducting screening-level testing. ; (3) in subsection (b)— (A) in paragraph (1)— (i) in subparagraph (B), by striking test data and inserting information ; (ii) in subparagraph (C), by striking data and inserting information ; and (iii) in the matter following subparagraph (C), by striking data and inserting information ; (B) in paragraph (2)— (i) in subparagraph (A)— (I) by striking test data and inserting information ; (II) by inserting Protocols and methodologies for the development of information may also be prescribed for the assessment of exposure or exposure potential to humans or the environment. after the first sentence; and (III) by striking hierarchical tests and inserting tiered testing ; and (ii) in subparagraph (B), by striking data and inserting information ; (C) in paragraph (3)— (i) by striking data each place it appears and inserting information ; (ii) in subparagraph (A), by inserting or (C), as applicable, after subparagraph (B) ; (iii) by striking (a)(1)(A)(ii) or (a)(1)(B)(ii) each place it appears in subparagraph (B) and inserting (a)(1)(A)(i)(II) or (a)(1)(A)(ii)(II) ; (iv) in subparagraph (B), in the matter before clause (i), by striking subsection (a) and inserting subsection (a)(1) ; and (v) by adding at the end the following: (C) A rule or order under paragraph (1) or (2) of subsection (a) may require the development of information by any person who manufactures or processes, or intends to manufacture or process, a chemical substance or mixture subject to the rule or order. ; (D) in paragraph (4)— (i) by striking of data each place it appears and inserting of information ; and (ii) by striking test data each place it appears and inserting information ; and (E) by striking paragraph (5); (4) in subsection (c)— (A) in paragraph (1), by striking data and inserting information ; (B) in paragraph (2), by striking data each place it appears and inserting information ; (C) in paragraph (3)— (i) by striking test data each place it appears and inserting information ; and (ii) by striking such data each place it appears and inserting such information ; and (D) in paragraph (4) by striking test data each place it appears and inserting information ; (5) in subsection (d)— (A) by striking test data each place it appears and inserting information ; (B) by striking such data each place it appears and inserting such information ; and (C) by striking for which data have and inserting for which information has ; (6) in subsection (e)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking promulgation of a rule and inserting development of information ; and (II) by striking data each place it appears and inserting information ; and (ii) in subparagraph (B), by striking either initiate a rulemaking proceeding under subsection (a) or if such a proceeding is not initiated within such period, publish in the Federal Register the Administrator's reason for not initiating such a proceeding and insert issue an order, enter into a consent agreement, or initiate a rulemaking proceeding under subsection (a), or, if such an order or consent agreement is not issued or such a proceeding is not initiated within such period, publish in the Federal Register the Administrator’s reason for not issuing such an order, entering into such a consent agreement, or initiating such a proceeding ; and (B) in paragraph (2)(A)— (i) by striking eight members and inserting ten members ; and (ii) by adding at the end the following: (ix) One member appointed by the Chairman of the Consumer Product Safety Commission from Commissioners or employees of the Commission. (x) One member appointed by the Commissioner of Food and Drugs from employees of the Food and Drug Administration. ; (7) in subsection (f)— (A) in paragraph (1), by striking test data and inserting information ; and (B) in the matter following paragraph (2)— (i) by striking or will present ; (ii) by striking from cancer, gene mutations, or birth defects ; (iii) by striking data or ; (iv) by striking appropriate and inserting applicable ; and (v) by inserting , made without consideration of costs or other nonrisk factors, after publish in the Federal Register a finding ; (8) in subsection (g)— (A) by amending the subsection heading to read as follows: Petition for protocols and methodologies for the development of information ; (B) by striking test data each place it appears and inserting information ; and (C) by striking submit data and inserting submit information ; and (9) by adding at the end the following: (h) Reduction of testing on vertebrates (1) In general The Administrator shall reduce and replace, to the extent practicable, scientifically justified, and consistent with the policies of this title, the use of vertebrate animals in the testing of chemical substances or mixtures under this title by— (A) prior to making a request or adopting a requirement for testing using vertebrate animals, and in accordance with subsection (a)(3), taking into consideration, as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including— (i) toxicity information; (ii) computational toxicology and bioinformatics; and (iii) high-throughput screening methods and the prediction models of those methods; and (B) encouraging and facilitating— (i) the use of scientifically valid test methods and strategies that reduce or replace the use of vertebrate animals while providing information of equivalent or better scientific quality and relevance that will support regulatory decisions under this title; (ii) the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category; and (iii) the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests, provided that such consortia make all information from such testing available to the Administrator. (2) Implementation of alternative testing methods To promote the development and timely incorporation of new scientifically valid test methods and strategies that are not based on vertebrate animals, the Administrator shall— (A) not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures through, for example— (i) computational toxicology and bioinformatics; (ii) high-throughput screening methods; (iii) testing of categories of chemical substances; (iv) tiered testing methods; (v) in vitro studies; (vi) systems biology; (vii) new or revised methods identified by validation bodies such as the Interagency Coordinating Committee on the Validation of Alternative Methods or the Organization for Economic Co-operation and Development; or (viii) industry consortia that develop information submitted under this title; (B) as practicable, ensure that the strategic plan developed under subparagraph (A) is reflected in the development of requirements for testing under this section; (C) include in the strategic plan developed under subparagraph (A) a list, which the Administrator shall update on a regular basis, of particular alternative test methods or strategies the Administrator has identified that do not require new vertebrate animal testing and are scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing; (D) provide an opportunity for public notice and comment on the contents of the plan developed under subparagraph (A), including the criteria for considering scientific reliability and relevance of the test methods and strategies that may be identified pursuant to subparagraph (C); (E) beginning on the date that is 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and every 5 years thereafter, submit to Congress a report that describes the progress made in implementing the plan developed under subparagraph (A) and goals for future alternative test methods and strategies implementation; and (F) prioritize and, to the extent consistent with available resources and the Administrator’s other responsibilities under this title, carry out performance assessment, validation, and translational studies to accelerate the development of scientifically valid test methods and strategies that reduce, refine, or replace the use of vertebrate animals, including minimizing duplication, in any testing under this title. (3) Voluntary testing (A) In general Any person developing information for submission under this title on a voluntary basis and not pursuant to any request or requirement by the Administrator shall first attempt to develop the information by means of an alternative test method or strategy identified by the Administrator pursuant to paragraph (2)(C), if the Administrator has identified such a test method or strategy for the development of such information, before conducting new vertebrate animal testing. (B) Effect of paragraph Nothing in this paragraph shall, under any circumstance, limit or restrict the submission of any existing information to the Administrator. (C) Relationship to other law A violation of this paragraph shall not be a prohibited act under section 15. (D) Review of means This paragraph authorizes, but does not require, the Administrator to review the means by which a person conducted testing described in subparagraph (A). . 5. Manufacturing and processing notices Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) by striking Except as provided in and inserting (A) Except as provided in subparagraph (B) of this paragraph and ; (ii) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively; (iii) by striking all that follows significant new use and inserting a period; and (iv) by adding at the end the following: (B) A person may take the actions described in subparagraph (A) if— (i) such person submits to the Administrator, at least 90 days before such manufacture or processing, a notice, in accordance with subsection (d), of such person’s intention to manufacture or process such substance and such person complies with any applicable requirement of, or imposed pursuant to, subsection (b), (e), or (f); and (ii) the Administrator— (I) conducts a review of the notice; and (II) makes a determination under subparagraph (A), (B), or (C) of paragraph (3) and takes the actions required in association with that determination under such subparagraph within the applicable review period. ; and (B) by adding at the end the following new paragraphs: (3) Review and determination Within the applicable review period, subject to section 18, the Administrator shall review such notice and determine— (A) that the relevant chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, in which case the Administrator shall take the actions required under subsection (f); (B) that— (i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of the relevant chemical substance or significant new use; or (ii) (I) in the absence of sufficient information to permit the Administrator to make such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator; or (II) such substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance, in which case the Administrator shall take the actions required under subsection (e); or (C) that the relevant chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, in which case the submitter of the notice may commence manufacture of the chemical substance or manufacture or processing for a significant new use. (4) Failure to render determination (A) Failure to render determination If the Administrator fails to make a determination on a notice under paragraph (3) by the end of the applicable review period and the notice has not been withdrawn by the submitter, the Administrator shall refund to the submitter all applicable fees charged to the submitter for review of the notice pursuant to section 26(b), and the Administrator shall not be relieved of any requirement to make such determination. (B) Limitations (i) A refund of applicable fees under subparagraph (A) shall not be made if the Administrator certifies that the submitter has not provided information required under subsection (b) or has otherwise unduly delayed the process such that the Administrator is unable to render a determination within the applicable review period. (ii) A failure of the Administrator to render a decision shall not be deemed to constitute a withdrawal of the notice. (iii) Nothing in this paragraph shall be construed as relieving the Administrator or the submitter of the notice from any requirement of this section. (5) Article consideration The Administrator may require notification under this section for the import or processing of a chemical substance as part of an article or category of articles under paragraph (1)(A)(ii) if the Administrator makes an affirmative finding in a rule under paragraph (2) that the reasonable potential for exposure to the chemical substance through the article or category of articles subject to the rule justifies notification. ; (2) in subsection (b)— (A) in the subsection heading, by striking Test Data and inserting Information ; (B) in paragraph (1)— (i) in subparagraph (A)— (I) by striking test data and inserting information ; and (II) by striking such data and inserting such information ; and (ii) in subparagraph (B)— (I) by striking test data and inserting information ; (II) by striking subsection (a)(1)(A) and inserting subsection (a)(1)(A)(i) ; and (III) by striking subsection (a)(1)(B) and inserting subsection (a)(1)(A)(ii) ; (C) in paragraph (2)— (i) in subparagraph (A)— (I) by striking test data in clause (ii) and inserting information ; (II) by striking shall and inserting may ; and (III) by striking data prescribed and inserting information prescribed ; and (ii) in subparagraph (B)— (I) by striking Data and inserting Information ; (II) by striking data both places it appears and inserting information ; (III) by striking show and inserting shows ; (IV) by striking subsection (a)(1)(A) in clause (i) and inserting subsection (a)(1)(A)(i) ; and (V) by striking subsection (a)(1)(B) in clause (ii) and inserting subsection (a)(1)(A)(ii) ; (D) in paragraph (3)— (i) by striking Data and inserting Information ; and (ii) by striking paragraph (1) or (2) and inserting paragraph (1) or (2) of this subsection or under subsection (e) ; and (E) in paragraph (4)— (i) in subparagraph (A)(i), by inserting , without consideration of costs or other nonrisk factors after health or the environment ; and (ii) in subparagraph (C), by striking , except that and all that follows through subparagraph (A) ; (3) in subsection (c)— (A) in the subsection heading, by striking Notice and inserting Review ; and (B) by striking before which and all that follows through subsection may begin ; (4) in subsection (d)— (A) by striking test data in paragraph (1)(B) and inserting information ; (B) by striking data each place it appears in paragraph (1)(C) and paragraph (2) and inserting information ; (C) in paragraph (2)(B), by striking uses or intended uses of such substance and inserting uses of such substance identified in the notice ; and (D) in paragraph (3)— (i) by striking for which the notification period prescribed by subsection (a), (b), or (c) and inserting for which the applicable review period ; and (ii) by striking such notification period and inserting such period ; (5) in subsection (e)— (A) in paragraph (1)(A)— (i) in clause (i), by striking ; and and inserting ; or ; (ii) in clause (ii)(I), by inserting without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed subpopulation identified as relevant by the Administrator under the conditions of use; after health or the environment, ; and (iii) in the matter after clause (ii)(II)— (I) by striking may issue a proposed order and inserting shall issue an order ; (II) by striking notification period applicable to the manufacturing or processing of such substance under subsection (a), (b), (c) and inserting applicable review period ; and (III) by inserting to the extent necessary to protect against an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, and the submitter of the notice may commence manufacture of the chemical substance, or manufacture or processing of the chemical substance for a significant new use, including while any required information is being developed, only in compliance with the order before the period at the end; (B) in paragraph (1)(B)— (i) by striking A proposed order and inserting An order ; (ii) by striking notification period applicable to the manufacture or processing of such substance under subsection (a), (b), (c) and inserting applicable review period ; and (iii) by striking of the proposed order and inserting of the order ; (C) by striking paragraph (1)(C); and (D) by striking paragraph (2); (6) in subsection (f)— (A) in paragraph (1)— (i) by striking finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance with and inserting determines that a chemical substance or significant new use with ; (ii) by striking , or that any combination of such activities, ; (iii) by striking or will present ; (iv) by striking before a rule promulgated under section 6 can protect against such risk, and inserting , without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed subpopulation identified as relevant by the Administrator under the conditions of use, ; and (v) by striking notification period applicable under subsection (a), (b), or (c) to the manufacturing or processing of such substance and inserting applicable review period ; (B) in paragraph (2), the matter following subparagraph (C), by striking Section 6(d)(2)(B) and inserting Section 6(d)(3)(B) ; (C) in paragraph (3)— (i) in subparagraph (A)— (I) by striking Administrator may and all that follows through issue a proposed order to prohibit the and inserting Administrator may issue an order to prohibit or limit the ; and (II) by striking under paragraph (1) and all that follows through processing of such substance. and inserting under paragraph (1). Such order shall take effect on the expiration of the applicable review period. ; (ii) by striking subparagraph (B) and redesignating subparagraph (C) as subparagraph (B); (iii) in subparagraph (B), as so redesignated— (I) by striking subparagraphs (B) and (C) and inserting subparagraph (B) ; (II) by striking clause (i) of ; and (III) by striking ; and the provisions of subparagraph (C) of subsection (e)(2) shall apply with respect to an injunction issued under subparagraph (B) ; and (iv) by striking subparagraph (D); and (D) by adding at the end the following: (4) Treatment of nonconforming uses Not later than 90 days after taking an action under paragraph (2) or (3) or issuing an order under subsection (e) relating to a chemical substance with respect to which the Administrator has made a determination under subsection (a)(3)(A) or (B), the Administrator shall consider whether to promulgate a rule pursuant to subsection (a)(2) that identifies as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance that does not conform to the restrictions imposed by the action or order, and, as applicable, initiate such a rulemaking or publish a statement describing the reasons of the Administrator for not initiating such a rulemaking. (5) Workplace exposures To the extent practicable, the Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health prior to adopting any prohibition or other restriction relating to a chemical substance with respect to which the Administrator has made a determination under subsection (a)(3)(A) or (B) to address workplace exposures. ; (7) by amending subsection (g) to read as follows: (g) Statement on administrator finding If the Administrator finds in accordance with subsection (a)(3)(C) that a chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, then notwithstanding any remaining portion of the applicable review period, the submitter of the notice may commence manufacture of the chemical substance or manufacture or processing for the significant new use, and the Administrator shall make public a statement of the Administrator’s finding. Such a statement shall be submitted for publication in the Federal Register as soon as is practicable before the expiration of such period. Publication of such statement in accordance with the preceding sentence is not a prerequisite to the manufacturing or processing of the substance with respect to which the statement is to be published. ; (8) in subsection (h)— (A) in paragraph (1)(A), by inserting , including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by the Administrator for the specific conditions of use identified in the application after health or the environment ; (B) in paragraph (2), by striking data each place it appears and inserting information ; and (C) in paragraph (4), by striking . A rule promulgated and all that follows through section 6(c) and inserting , including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by the Administrator under the conditions of use ; and (9) by amending subsection (i) to read as follows: (i) Definitions (1) For purposes of this section, the terms manufacture and process mean manufacturing or processing for commercial purposes. (2) For purposes of this Act, the term requirement as used in this section shall not displace any statutory or common law. (3) For purposes of this section, the term applicable review period means the period starting on the date the Administrator receives a notice under subsection (a)(1) and ending 90 days after that date, or on such date as is provided for in subsection (b)(1) or (c). . 6. Prioritization, risk evaluation, and regulation of chemical substances and mixtures Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— (1) by striking the section heading and inserting Prioritization, risk evaluation, and regulation of chemical substances and mixtures ; (2) in subsection (a)— (A) by striking finds that there is a reasonable basis to conclude and inserting determines in accordance with subsection (b)(4)(A) ; (B) by striking or will present ; (C) by inserting and subject to section 18, and in accordance with subsection (c)(2), after shall by rule ; (D) by striking to protect adequately against such risk using the least burdensome requirements and inserting so that the chemical substance or mixture no longer presents such risk ; (E) by inserting or otherwise restricting after prohibiting in paragraphs (1)(A) and (2)(A); (F) by inserting minimum before warnings both places it appears in paragraph (3); (G) by striking and monitor or conduct tests and inserting or monitor or conduct tests in paragraph (4); and (H) in paragraph (7)— (i) by striking such unreasonable risk of injury and inserting such determination ; and (ii) by striking such risk of injury and inserting such determination ; (3) by amending subsection (b) to read as follows: (b) Risk evaluations (1) Prioritization for risk evaluations (A) Establishment of process Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall establish, by rule, a risk-based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time. The process to designate the priority of chemical substances shall include a consideration of the hazard and exposure potential of a chemical substance or a category of chemical substances (including consideration of persistence and bioaccumulation, potentially exposed or susceptible subpopulations and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed. (B) Identification of priorities for risk evaluation (i) High-priority substances The Administrator shall designate as a high-priority substance a chemical substance that the Administrator concludes, without consideration of costs or other nonrisk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator. (ii) Low-priority substances The Administrator shall designate a chemical substance as a low-priority substance if the Administrator concludes, based on information sufficient to establish, without consideration of costs or other nonrisk factors, that such substance does not meet the standard identified in clause (i) for designating a chemical substance a high-priority substance. (C) Information request and review and proposed and final prioritization designation The rulemaking required in subparagraph (A) shall ensure that the time required to make a priority designation of a chemical substance be no shorter than nine months and no longer than 1 year, and that the process for such designations includes— (i) a requirement that the Administrator request interested persons to submit relevant information on a chemical substance that the Administrator has initiated the prioritization process on, before proposing a priority designation for the chemical substance, and provide 90 days for such information to be provided; (ii) a requirement that the Administrator publish each proposed designation of a chemical substance as a high- or low-priority substance, along with an identification of the information, analysis, and basis used to make the proposed designations, and provide 90 days for public comment on each such proposed designation; and (iii) a process by which the Administrator may extend the deadline in clause (i) for up to three months in order to receive or evaluate information required to be submitted in accordance with section 4(a)(2)(B), subject to the limitation that if the information available to the Administrator at the end of such an extension remains insufficient to enable the designation of the chemical substance as a low-priority substance, the Administrator shall designate the chemical substance as a high-priority substance. (2) Initial risk evaluations and subsequent designations of high- and low-priority substances (A) Initial risk evaluations Not later than 180 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall ensure that risk evaluations are being conducted on 10 chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments and shall publish the list of such chemical substances during the 180 day period. (B) Additional risk evaluations Not later than three and one half years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall ensure that risk evaluations are being conducted on at least 20 high-priority substances and that at least 20 chemical substances have been designated as low-priority substances, subject to the limitation that at least 50 percent of all chemical substances on which risk evaluations are being conducted by the Administrator are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments. (C) Continuing designations and risk evaluations The Administrator shall continue to designate priority substances and conduct risk evaluations in accordance with this subsection at a pace consistent with the ability of the Administrator to complete risk evaluations in accordance with the deadlines under paragraph (4)(G). (D) Preference In designating high-priority substances, the Administrator shall give preference to— (i) chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments as having a Persistence and Bioaccumulation Score of 3; and (ii) chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments that are known human carcinogens and have high acute and chronic toxicity. (E) Metals and metal compounds In identifying priorities for risk evaluation and conducting risk evaluations of metals and metal compounds, the Administrator shall use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated March 2007, or a successor document that addresses metals risk assessment and is peer reviewed by the Science Advisory Board. (3) Initiation of risk evaluations; designations (A) Risk evaluation initiation Upon designating a chemical substance as a high-priority substance, the Administrator shall initiate a risk evaluation on the substance. (B) Revision The Administrator may revise the designation of a low-priority substance based on information made available to the Administrator. (C) Ongoing designations The Administrator shall designate at least one high-priority substance upon the completion of each risk evaluation (other than risk evaluations for chemical substances designated under paragraph (4)(C)(ii)). (4) Risk evaluation process and deadlines (A) In general The Administrator shall conduct risk evaluations pursuant to this paragraph to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use. (B) Establishment of process Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A). (C) Requirement The Administrator shall conduct and publish risk evaluations, in accordance with the rule promulgated under subparagraph (B), for a chemical substance— (i) that has been identified under paragraph (2)(A) or designated under paragraph (1)(B)(i); and (ii) subject to subparagraph (E), that a manufacturer of the chemical substance has requested, in a form and manner and using the criteria prescribed by the Administrator in the rule promulgated under subparagraph (B), be subjected to a risk evaluation. (D) Scope The Administrator shall, not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider, and, for each designation of a high-priority substance, ensure not less than 12 months between the initiation of the prioritization process for the chemical substance and the publication of the scope of the risk evaluation for the chemical substance, and for risk evaluations conducted on chemical substances that have been identified under paragraph (2)(A) or selected under subparagraph (E)(iv)(II) of this paragraph, ensure not less than 3 months before the Administrator publishes the scope of the risk evaluation. (E) Limitation and criteria (i) Percentage requirements The Administrator shall ensure that, of the number of chemical substances that undergo a risk evaluation under clause (i) of subparagraph (C), the number of chemical substances undergoing a risk evaluation under clause (ii) of subparagraph (C) is— (I) not less than 25 percent, if sufficient requests are made under clause (ii) of subparagraph (C); and (II) not more than 50 percent. (ii) Requested risk evaluations Requests for risk evaluations under subparagraph (C)(ii) shall be subject to the payment of fees pursuant to section 26(b), and the Administrator shall not expedite or otherwise provide special treatment to such risk evaluations. (iii) Preference In deciding whether to grant requests under subparagraph (C)(ii), the Administrator shall give preference to requests for risk evaluations on chemical substances for which the Administrator determines that restrictions imposed by 1 or more States have the potential to have a significant impact on interstate commerce or health or the environment. (iv) Exceptions (I) Chemical substances for which requests have been granted under subparagraph (C)(ii) shall not be subject to section 18(b). (II) Requests for risk evaluations on chemical substances which are made under subparagraph (C)(ii) and that are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments shall be granted at the discretion of the Administrator and not be subject to clause (i)(II). (F) Requirements In conducting a risk evaluation under this subsection, the Administrator shall— (i) integrate and assess available information on hazards and exposures for the conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed or susceptible subpopulations identified as relevant by the Administrator; (ii) describe whether aggregate or sentinel exposures to a chemical substance under the conditions of use were considered, and the basis for that consideration; (iii) not consider costs or other nonrisk factors; (iv) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use of the chemical substance; and (v) describe the weight of the scientific evidence for the identified hazard and exposure. (G) Deadlines The Administrator— (i) shall complete a risk evaluation for a chemical substance as soon as practicable, but not later than 3 years after the date on which the Administrator initiates the risk evaluation under subparagraph (C); and (ii) may extend the deadline for a risk evaluation for not more than 6 months. (H) Notice and comment The Administrator shall provide no less than 30 days public notice and an opportunity for comment on a draft risk evaluation prior to publishing a final risk evaluation. ; (4) by amending subsection (c) to read as follows: (c) Promulgation of subsection (a) rules (1) Deadlines If the Administrator determines that a chemical substance presents an unreasonable risk of injury to health or the environment in accordance with subsection (b)(4)(A), the Administrator— (A) shall propose in the Federal Register a rule under subsection (a) for the chemical substance not later than 1 year after the date on which the final risk evaluation regarding the chemical substance is published; (B) shall publish in the Federal Register a final rule not later than 2 years after the date on which the final risk evaluation regarding the chemical substance is published; and (C) may extend the deadlines under this paragraph for not more than 2 years, subject to the condition that the aggregate length of extensions under this subparagraph and subsection (b)(4)(G)(ii) does not exceed 2 years, and subject to the limitation that the Administrator may not extend a deadline for the publication of a proposed or final rule regarding a chemical substance drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments or a chemical substance that, with respect to persistence and bioaccumulation, scores high for 1 and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012 (or a successor scoring system), without adequate public justification that demonstrates, following a review of the information reasonably available to the Administrator, that the Administrator cannot complete the proposed or final rule without additional information regarding the chemical substance. (2) Requirements for rule (A) Statement of effects In proposing and promulgating a rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall consider and publish a statement based on reasonably available information with respect to— (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture; (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture; (iii) the benefits of the chemical substance or mixture for various uses; and (iv) the reasonably ascertainable economic consequences of the rule, including consideration of— (I) the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; (II) the costs and benefits of the proposed and final regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator; and (III) the cost effectiveness of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator. (B) Selecting requirements In selecting among prohibitions and other restrictions, the Administrator shall factor in, to the extent practicable, the considerations under subparagraph (A) in accordance with subsection (a). (C) Consideration of alternatives Based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, the Administrator shall consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect. (D) Replacement parts (i) In general The Administrator shall exempt replacement parts for complex durable goods and complex consumer goods that are designed prior to the date of publication in the Federal Register of the rule under subsection (a), unless the Administrator finds that such replacement parts contribute significantly to the risk, identified in a risk evaluation conducted under subsection (b)(4)(A), to the general population or to an identified potentially exposed or susceptible subpopulation. (ii) Definitions In this subparagraph— (I) the term complex consumer goods means electronic or mechanical devices composed of multiple manufactured components, with an intended useful life of 3 or more years, where the product is typically not consumed, destroyed, or discarded after a single use, and the components of which would be impracticable to redesign or replace; and (II) the term complex durable goods means manufactured goods composed of 100 or more manufactured components, with an intended useful life of 5 or more years, where the product is typically not consumed, destroyed, or discarded after a single use. (E) Articles In selecting among prohibitions and other restrictions, the Administrator shall apply such prohibitions or other restrictions to an article or category of articles containing the chemical substance or mixture only to the extent necessary to address the identified risks from exposure to the chemical substance or mixture from the article or category of articles so that the substance or mixture does not present an unreasonable risk of injury to health or the environment identified in the risk evaluation conducted in accordance with subsection (b)(4)(A). (3) Procedures When prescribing a rule under subsection (a) the Administrator shall proceed in accordance with section 553 of title 5, United States Code (without regard to any reference in such section to sections 556 and 557 of such title), and shall also— (A) publish a notice of proposed rulemaking stating with particularity the reason for the proposed rule; (B) allow interested persons to submit written data, views, and arguments, and make all such submissions publicly available; (C) promulgate a final rule based on the matter in the rulemaking record; and (D) make and publish with the rule the determination described in subsection (a). ; (5) in subsection (d)— (A) by redesignating paragraph (2) as paragraph (3); (B) by striking paragraph (1) and inserting the following: (1) In general In any rule under subsection (a), the Administrator shall— (A) specify the date on which it shall take effect, which date shall be as soon as practicable; (B) except as provided in subparagraphs (C) and (D), specify mandatory compliance dates for all of the requirements under a rule under subsection (a), which shall be as soon as practicable, but not later than 5 years after the date of promulgation of the rule, except in a case of a use exempted under subsection (g); (C) specify mandatory compliance dates for the start of ban or phase-out requirements under a rule under subsection (a), which shall be as soon as practicable, but not later than 5 years after the date of promulgation of the rule, except in the case of a use exempted under subsection (g); (D) specify mandatory compliance dates for full implementation of ban or phase-out requirements under a rule under subsection (a), which shall be as soon as practicable; and (E) provide for a reasonable transition period. (2) Variability As determined by the Administrator, the compliance dates established under paragraph (1) may vary for different affected persons. ; and (C) in paragraph (3), as so redesignated by subparagraph (A) of this paragraph— (i) in subparagraph (A)— (I) by striking upon its publication and all that follows through respecting such rule if and inserting , and compliance with the proposed requirements to be mandatory, upon publication in the Federal Register of the proposed rule and until the compliance dates applicable to such requirements in a final rule promulgated under section 6(a) or until the Administrator revokes such proposed rule, in accordance with subparagraph (B), if ; and (II) in clause (i)(I), by inserting without consideration of costs or other non-risk factors after effective date ; and (ii) in subparagraph (B), by striking , provide reasonable opportunity and all that follows through the period at the end and inserting in accordance with subsection (c), and either promulgate such rule (as proposed or with modifications) or revoke it. ; (6) in subsection (e)(4), by striking paragraphs (2), (3), and (4) and inserting paragraph (3) ; and (7) by adding at the end the following new subsections: (g) Exemptions (1) Criteria for exemption The Administrator may, as part of a rule promulgated under subsection (a), or in a separate rule, grant an exemption from a requirement of a subsection (a) rule for a specific condition of use of a chemical substance or mixture, if the Administrator finds that— (A) the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; (B) compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or (C) the specific condition of use of the chemical substance or mixture, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. (2) Exemption analysis and statement In proposing an exemption under this subsection, the Administrator shall analyze the need for the exemption, and shall make public the analysis and a statement describing how the analysis was taken into account. (3) Period of exemption The Administrator shall establish, as part of a rule under this subsection, a time limit on any exemption for a time to be determined by the Administrator as reasonable on a case-by-case basis, and, by rule, may extend, modify, or eliminate an exemption if the Administrator determines, on the basis of reasonably available information and after adequate public justification, the exemption warrants extension or modification or is no longer necessary. (4) Conditions As part of a rule promulgated under this subsection, the Administrator shall include conditions, including reasonable recordkeeping, monitoring, and reporting requirements, to the extent that the Administrator determines the conditions are necessary to protect health and the environment while achieving the purposes of the exemption. (h) Chemicals that are persistent, bioaccumulative, and toxic (1) Expedited action Not later than 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall propose rules under subsection (a) with respect to chemical substances identified in the 2014 update of the TSCA Work Plan for Chemical Assessments— (A) that the Administrator has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012 (or a successor scoring system), and are not a metal or a metal compound, and for which the Administrator has not completed a Work Plan Problem Formulation, initiated a review under section 5, or entered into a consent agreement under section 4, prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; and (B) exposure to which under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator, or the environment, on the basis of an exposure and use assessment conducted by the Administrator. (2) No risk evaluation required The Administrator shall not be required to conduct risk evaluations on chemical substances that are subject to paragraph (1). (3) Final rule Not later than 18 months after proposing a rule pursuant to paragraph (1), the Administrator shall promulgate a final rule under subsection (a). (4) Selecting restrictions In selecting among prohibitions and other restrictions promulgated in a rule under subsection (a) pursuant to paragraph (1), the Administrator shall address the risks of injury to health or the environment that the Administrator determines are presented by the chemical substance and shall reduce exposure to the substance to the extent practicable. (5) Relationship to subsection (b) If, at any time prior to the date that is 90 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator makes a designation under subsection (b)(1)(B)(i), or receives a request under subsection (b)(4)(C)(ii), such chemical substance shall not be subject to this subsection, except that in selecting among prohibitions and other restrictions promulgated in a rule pursuant to subsection (a), the Administrator shall both ensure that the chemical substance meets the rulemaking standard under subsection (a) and reduce exposure to the substance to the extent practicable. (i) Final agency action Under this section and subject to section 18— (1) a determination by the Administrator under subsection (b)(4)(A) that a chemical substance does not present an unreasonable risk of injury to health or the environment shall be issued by order and considered to be a final agency action, effective beginning on the date of issuance of the order; and (2) a final rule promulgated under subsection (a), including the associated determination by the Administrator under subsection (b)(4)(A) that a chemical substance presents an unreasonable risk of injury to health or the environment, shall be considered to be a final agency action, effective beginning on the date of promulgation of the final rule. (j) Definition For the purposes of this Act, the term requirement as used in this section shall not displace statutory or common law. . 7. Imminent hazards Section 7 of the Toxic Substances Control Act ( 15 U.S.C. 2606 ) is amended— (1) in subsection (b)(1), by inserting (as identified by the Administrator without consideration of costs or other nonrisk factors) after from the unreasonable risk ; and (2) in subsection (f), by inserting , without consideration of costs or other nonrisk factors after widespread injury to health or the environment . 8. Reporting and retention of information (a) In general Section 8 of the Toxic Substances Control Act ( 15 U.S.C. 2607 ) is amended— (1) in subsection (a)— (A) in paragraph (2), by striking the matter that follows subparagraph (G); (B) in paragraph (3), by adding at the end the following: (C) Not later than 180 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and not less frequently than once every 10 years thereafter, the Administrator, after consultation with the Administrator of the Small Business Administration, shall— (i) review the adequacy of the standards prescribed under subparagraph (B); and (ii) after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted. ; and (C) by adding at the end the following: (4) Contents The rules promulgated pursuant to paragraph (1)— (A) may impose differing reporting and recordkeeping requirements on manufacturers and processors; and (B) shall include the level of detail necessary to be reported, including the manner by which use and exposure information may be reported. (5) Administration In carrying out this section, the Administrator shall, to the extent feasible— (A) not require reporting which is unnecessary or duplicative; (B) minimize the cost of compliance with this section and the rules issued thereunder on small manufacturers and processors; and (C) apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this title. (6) Negotiated rulemaking (A) The Administrator shall enter into a negotiated rulemaking pursuant to subchapter III of chapter 5 of title 5, United States Code, to develop and publish, not later than 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , a proposed rule providing for limiting the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed. (B) Not later than 3 and one-half years after such date of enactment, the Administrator shall publish a final rule resulting from such negotiated rulemaking. ; and (2) in subsection (b), by adding at the end the following: (3) Nomenclature (A) In general In carrying out paragraph (1), the Administrator shall— (i) maintain the use of Class 2 nomenclature in use on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; (ii) maintain the use of the Soap and Detergent Association Nomenclature System, published in March 1978 by the Administrator in section 1 of addendum III of the document entitled Candidate List of Chemical Substances , and further described in the appendix A of volume I of the 1985 edition of the Toxic Substances Control Act Substances Inventory (EPA Document No. EPA–560/7–85–002a); and (iii) treat the individual members of the categories of chemical substances identified by the Administrator as statutory mixtures, as defined in Inventory descriptions established by the Administrator, as being included on the list established under paragraph (1). (B) Multiple nomenclature listings If a manufacturer or processor demonstrates to the Administrator that a chemical substance appears multiple times on the list published under paragraph (1) under different CAS numbers, the Administrator may recognize the multiple listings as a single chemical substance. (4) Chemical substances in commerce (A) Rules (i) In general Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator, by rule, shall require manufacturers, and may require processors, subject to the limitations under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (ii) Active substances The Administrator shall designate chemical substances for which notices are received under clause (i) to be active substances on the list published under paragraph (1). (iii) Inactive substances The Administrator shall designate chemical substances for which no notices are received under clause (i) to be inactive substances on the list published under paragraph (1). (iv) Limitation No chemical substance on the list published under paragraph (1) shall be removed from such list by reason of the implementation of this subparagraph, or be subject to section 5(a)(1)(A)(i) by reason of a change to active status under paragraph (5)(B). (B) Confidential chemical substances In promulgating a rule under subparagraph (A), the Administrator shall— (i) maintain the list under paragraph (1), which shall include a confidential portion and a nonconfidential portion consistent with this section and section 14; (ii) require any manufacturer or processor of a chemical substance on the confidential portion of the list published under paragraph (1) that seeks to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential pursuant to section 14 to submit a notice under subparagraph (A) that includes such request; (iii) require the substantiation of those claims pursuant to section 14 and in accordance with the review plan described in subparagraph (C); and (iv) move any active chemical substance for which no request was received to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential from the confidential portion of the list published under paragraph (1) to the nonconfidential portion of that list. (C) Review plan Not later than 1 year after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A), the Administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the list published under paragraph (1) that are asserted pursuant to subparagraph (B). (D) Requirements of review plan In establishing the review plan under subparagraph (C), the Administrator shall— (i) require, at a time specified by the Administrator, all manufacturers or processors asserting claims under subparagraph (B) to substantiate the claim, in accordance with section 14, unless the manufacturer or processor has substantiated the claim in a submission made to the Administrator during the 5-year period ending on the last day of the of the time period specified by the Administrator; and (ii) in accordance with section 14— (I) review each substantiation— (aa) submitted pursuant to clause (i) to determine if the claim qualifies for protection from disclosure; and (bb) submitted previously by a manufacturer or processor and relied on in lieu of the substantiation required pursuant to clause (i), if the substantiation has not been previously reviewed by the Administrator, to determine if the claim warrants protection from disclosure; (II) approve, approve in part and deny in part, or deny each claim; and (III) except as provided in this section and section 14, protect from disclosure information for which the Administrator approves such a claim for a period of 10 years, unless, prior to the expiration of the period— (aa) the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall not protect the information from disclosure; or (bb) the Administrator otherwise becomes aware that the information does not qualify for protection from disclosure, in which case the Administrator shall take the actions described in section 14(g)(2). (E) Timeline for completion of reviews (i) In general The Administrator shall implement the review plan so as to complete reviews of all claims specified in subparagraph (C) not later than 5 years after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A). (ii) Considerations (I) In general The Administrator may extend the deadline for completion of the reviews for not more than 2 additional years, after an adequate public justification, if the Administrator determines that the extension is necessary based on the number of claims needing review and the available resources. (II) Annual review goal and results At the beginning of each year, the Administrator shall publish an annual goal for reviews and the number of reviews completed in the prior year. (5) Active and inactive substances (A) In general The Administrator shall keep designations of active substances and inactive substances on the list published under paragraph (1) current. (B) Change to active status (i) In general Any person that intends to manufacture or process for a nonexempt commercial purpose a chemical substance that is designated as an inactive substance shall notify the Administrator before the date on which the inactive substance is manufactured or processed. (ii) Confidential chemical identity If a person submitting a notice under clause (i) for an inactive substance on the confidential portion of the list published under paragraph (1) seeks to maintain an existing claim for protection against disclosure of the specific chemical identity of the inactive substance as confidential, the person shall, consistent with the requirements of section 14— (I) in the notice submitted under clause (i), assert the claim; and (II) by not later than 30 days after providing the notice under clause (i), substantiate the claim. (iii) Active status On receiving a notification under clause (i), the Administrator shall— (I) designate the applicable chemical substance as an active substance; (II) pursuant to section 14, promptly review any claim and associated substantiation submitted pursuant to clause (ii) for protection against disclosure of the specific chemical identity of the chemical substance and approve, approve in part and deny in part, or deny the claim; (III) except as provided in this section and section 14, protect from disclosure the specific chemical identity of the chemical substance for which the Administrator approves a claim under subclause (II) for a period of 10 years, unless, prior to the expiration of the period— (aa) the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall not protect the information from disclosure; or (bb) the Administrator otherwise becomes aware that the information does not qualify for protection from disclosure, in which case the Administrator shall take the actions described in section 14(g)(2); and (IV) pursuant to section 6(b), review the priority of the chemical substance as the Administrator determines to be necessary. (C) Category status The list of inactive substances shall not be considered to be a category for purposes of section 26(c). (6) Interim list of active substances Prior to the promulgation of the rule required under paragraph (4)(A), the Administrator shall designate the chemical substances reported under part 711 of title 40, Code of Federal Regulations (as in effect on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ), during the reporting period that most closely preceded the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , as the interim list of active substances for the purposes of section 6(b). (7) Public information Subject to this subsection and section 14, the Administrator shall make available to the public— (A) each specific chemical identity on the nonconfidential portion of the list published under paragraph (1) along with the Administrator’s designation of the chemical substance as an active or inactive substance; (B) the unique identifier assigned under section 14, accession number, generic name, and, if applicable, premanufacture notice case number for each chemical substance on the confidential portion of the list published under paragraph (1) for which a claim of confidentiality was received; and (C) the specific chemical identity of any active substance for which— (i) a claim for protection against disclosure of the specific chemical identity of the active substance was not asserted, as required under this subsection or section 14; (ii) all claims for protection against disclosure of the specific chemical identity of the active substance have been denied by the Administrator; or (iii) the time period for protection against disclosure of the specific chemical identity of the active substance has expired. (8) Limitation No person may assert a new claim under this subsection or section 14 for protection from disclosure of a specific chemical identity of any active or inactive substance for which a notice is received under paragraph (4)(A)(i) or (5)(B)(i) that is not on the confidential portion of the list published under paragraph (1). (9) Certification Under the rules promulgated under this subsection, manufacturers and processors, as applicable, shall be required— (A) to certify that each notice or substantiation the manufacturer or processor submits complies with the requirements of the rule, and that any confidentiality claims are true and correct; and (B) to retain a record documenting compliance with the rule and supporting confidentiality claims for a period of 5 years beginning on the last day of the submission period. . (b) Mercury inventory Section 8(b) of the Toxic Substances Control Act ( 15 U.S.C. 2607(b) ) (as amended by subsection (a)) is further amended by adding at the end the following: (10) Mercury (A) Definition of mercury In this paragraph, notwithstanding section 3(2)(B), the term mercury means— (i) elemental mercury; and (ii) a mercury compound. (B) Publication Not later than April 1, 2017, and every 3 years thereafter, the Administrator shall carry out and publish in the Federal Register an inventory of mercury supply, use, and trade in the United States. (C) Process In carrying out the inventory under subparagraph (B), the Administrator shall— (i) identify any manufacturing processes or products that intentionally add mercury; and (ii) recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use. (D) Reporting (i) In general To assist in the preparation of the inventory under subparagraph (B), any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the Administrator, at such time and including such information as the Administrator shall determine by rule promulgated not later than 2 years after the date of enactment of this paragraph. (ii) Coordination To avoid duplication, the Administrator shall coordinate the reporting under this subparagraph with the Interstate Mercury Education and Reduction Clearinghouse. (iii) Exemption Clause (i) shall not apply to a person engaged in the generation, handling, or management of mercury-containing waste, unless that person manufactures or recovers mercury in the management of that waste. . 9. Relationship to other Federal laws Section 9 of the Toxic Substances Control Act ( 15 U.S.C. 2608 ) is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) by striking has reasonable basis to conclude and inserting determines ; (ii) by striking or will present ; and (iii) by inserting , without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator, under the conditions of use, after or the environment ; (B) in paragraph (2)— (i) in subparagraph (A), by inserting , within the time period specified by the Administrator in the report, after issues an order ; and (ii) in subparagraph (B), by inserting responds within the time period specified by the Administrator in the report and before initiates, within 90 ; (C) by redesignating paragraph (3) as paragraph (6); and (D) by inserting after paragraph (2) the following: (3) The Administrator shall take the actions described in paragraph (4) if the Administrator makes a report under paragraph (1) with respect to a chemical substance or mixture and the agency to which the report was made does not— (A) issue the order described in paragraph (2)(A) within the time period specified by the Administrator in the report; or (B) (i) respond under paragraph (1) within the timeframe specified by the Administrator in the report; and (ii) initiate action within 90 days of publication in the Federal Register of the response described in clause (i). (4) If an agency to which a report is submitted under paragraph (1) does not take the actions described in subparagraph (A) or (B) of paragraph (3), the Administrator shall— (A) initiate or complete appropriate action under section 6; or (B) take any action authorized or required under section 7, as applicable. (5) This subsection shall not relieve the Administrator of any obligation to take any appropriate action under section 6(a) or 7 to address risks from the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or any combination of those activities, that are not identified in a report issued by the Administrator under paragraph (1). ; (2) in subsection (b)— (A) by striking The Administrator shall coordinate and inserting (1) The Administrator shall coordinate ; and (B) by adding at the end the following: (2) In making a determination under paragraph (1) that it is in the public interest for the Administrator to take an action under this title with respect to a chemical substance or mixture rather than under another law administered in whole or in part by the Administrator, the Administrator shall consider, based on information reasonably available to the Administrator, all relevant aspects of the risk described in paragraph (1) and a comparison of the estimated costs and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk. ; and (3) by adding at the end the following: (e) Exposure information In addition to the requirements of subsection (a), if the Administrator obtains information related to exposures or releases of a chemical substance or mixture that may be prevented or reduced under another Federal law, including a law not administered by the Administrator, the Administrator shall make such information available to the relevant Federal agency or office of the Environmental Protection Agency. . 10. Exports (a) In general Section 12(a)(2) of the Toxic Substances Control Act ( 15 U.S.C. 2611(a)(2) ) is amended by striking will present and inserting presents . (b) Prohibition on export of certain mercury compounds Section 12(c) of the Toxic Substances Control Act ( 15 U.S.C. 2611(c) ) is amended— (1) in the subsection heading, by inserting and Mercury Compounds after Mercury ; and (2) by adding at the end the following: (7) Prohibition on export of certain mercury compounds (A) In general Effective January 1, 2020, the export of the following mercury compounds is prohibited: (i) Mercury (I) chloride or calomel. (ii) Mercury (II) oxide. (iii) Mercury (II) sulfate. (iv) Mercury (II) nitrate. (v) Cinnabar or mercury sulphide. (vi) Any mercury compound that the Administrator adds to the list published under subparagraph (B) by rule, on determining that exporting that mercury compound for the purpose of regenerating elemental mercury is technically feasible. (B) Publication Not later than 90 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and as appropriate thereafter, the Administrator shall publish in the Federal Register a list of the mercury compounds that are prohibited from export under this paragraph. (C) Petition Any person may petition the Administrator to add a mercury compound to the list published under subparagraph (B). (D) Environmentally sound disposal This paragraph does not prohibit the export of mercury compounds on the list published under subparagraph (B) to member countries of the Organization for Economic Co-operation and Development for environmentally sound disposal, on the condition that no mercury or mercury compounds so exported are to be recovered, recycled, or reclaimed for use, or directly reused, after such export. (E) Report Not later than 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall evaluate any exports of mercury compounds on the list published under subparagraph (B) for disposal that occurred after such date of enactment and shall submit to Congress a report that— (i) describes volumes and sources of mercury compounds on the list published under subparagraph (B) exported for disposal; (ii) identifies receiving countries of such exports; (iii) describes methods of disposal used after such export; (iv) identifies issues, if any, presented by the export of mercury compounds on the list published under subparagraph (B); (v) includes an evaluation of management options in the United States for mercury compounds on the list published under subparagraph (B), if any, that are commercially available and comparable in cost and efficacy to methods being utilized in such receiving countries; and (vi) makes a recommendation regarding whether Congress should further limit or prohibit the export of mercury compounds on the list published under subparagraph (B) for disposal. (F) Effect on other law Nothing in this paragraph shall be construed to affect the authority of the Administrator under the Solid Waste Disposal Act ( 42 U.S.C. 6901 et seq. ). . (c) Temporary generator accumulation Section 5 of the Mercury Export Ban Act of 2008 ( 42 U.S.C. 6939f ) is amended— (1) in subsection (a)(2), by striking 2013 and inserting 2019 ; (2) in subsection (b)— (A) in paragraph (1)— (i) by redesignating subparagraphs (A), (B), and (C), as clauses (i), (ii), and (iii), respectively and indenting appropriately; (ii) in the first sentence, by striking After consultation and inserting the following: (A) Assessment and collection After consultation ; (iii) in the second sentence, by striking The amount of such fees and inserting the following: (B) Amount The amount of the fees described in subparagraph (A) ; (iv) in subparagraph (B) (as so designated)— (I) in clause (i) (as so redesignated), by striking publically available not later than October 1, 2012 and inserting publicly available not later than October 1, 2018 ; (II) in clause (ii) (as so redesignated), by striking and ; (III) in clause (iii) (as so redesignated), by striking the period at the end and inserting , subject to clause (iv); and ; and (IV) by adding at the end the following: (iv) for generators temporarily accumulating elemental mercury in a facility subject to subparagraphs (B) and (D)(iv) of subsection (g)(2) if the facility designated in subsection (a) is not operational by January 1, 2019, shall be adjusted to subtract the cost of the temporary accumulation during the period in which the facility designated under subsection (a) is not operational. ; and (v) by adding at the end the following: (C) Conveyance of title and permitting If the facility designated in subsection (a) is not operational by January 1, 2020, the Secretary— (i) shall immediately accept the conveyance of title to all elemental mercury that has accumulated in facilities in accordance with subsection (g)(2)(D), before January 1, 2020, and deliver the accumulated mercury to the facility designated under subsection (a) on the date on which the facility becomes operational; (ii) shall pay any applicable Federal permitting costs, including the costs for permits issued under section 3005(c) of the Solid Waste Disposal Act ( 42 U.S.C. 6925(c) ); and (iii) shall store, or pay the cost of storage of, until the time at which a facility designated in subsection (a) is operational, accumulated mercury to which the Secretary has title under this subparagraph in a facility that has been issued a permit under section 3005(c) of the Solid Waste Disposal Act ( 42 U.S.C. 6925(c) ). ; and (B) in paragraph (2), in the first sentence, by striking paragraph (1)(C) and inserting paragraph (1)(B)(iii) ; and (3) in subsection (g)(2)— (A) in the undesignated material at the end, by striking This subparagraph and inserting the following: (C) Subparagraph (B) ; (B) in subparagraph (C) (as designated by subparagraph (A)), by inserting of that subparagraph before the period at the end; and (C) by adding at the end the following: (D) A generator producing elemental mercury incidentally from the beneficiation or processing of ore or related pollution control activities may accumulate the mercury produced onsite that is destined for a facility designated by the Secretary under subsection (a) for more than 90 days without a permit issued under section 3005(c) of the Solid Waste Disposal Act ( 42 U.S.C. 6925(c) ), and shall not be subject to the storage prohibition of section 3004(j) of that Act ( 42 U.S.C. 6924(j) ), if— (i) the Secretary is unable to accept the mercury at a facility designated by the Secretary under subsection (a) for reasons beyond the control of the generator; (ii) the generator certifies in writing to the Secretary that the generator will ship the mercury to a designated facility when the Secretary is able to accept the mercury; (iii) the generator certifies in writing to the Secretary that the generator is storing only mercury the generator has produced or recovered onsite and will not sell, or otherwise place into commerce, the mercury; and (iv) the generator has obtained an identification number under section 262.12 of title 40, Code of Federal Regulations, and complies with the requirements described in paragraphs (1) through (4) of section 262.34(a) of title 40, Code of Federal Regulations (as in effect on the date of enactment of this subparagraph). (E) Management standards for temporary storage Not later than January 1, 2017, the Secretary, after consultation with the Administrator of the Environmental Protection Agency and State agencies in affected States, shall develop and make available guidance that establishes procedures and standards for the management and short-term storage of elemental mercury at a generator covered under subparagraph (D), including requirements to ensure appropriate use of flasks or other suitable containers. Such procedures and standards shall be protective of health and the environment and shall ensure that the elemental mercury is stored in a safe, secure, and effective manner. A generator may accumulate mercury in accordance with subparagraph (D) immediately upon enactment of this subparagraph, and notwithstanding that guidance called for by this paragraph has not been developed or made available. . (d) Interim status Section 5(d)(1) of the Mercury Export Ban Act of 2008 ( 42 U.S.C. 6939f(d)(1) ) is amended— (1) in the fourth sentence, by striking in existence on or before January 1, 2013, ; and (2) in the last sentence, by striking January 1, 2015 and inserting January 1, 2020 . 11. Confidential information Section 14 of the Toxic Substances Control Act ( 15 U.S.C. 2613 ) is amended to read as follows: 14. Confidential information (a) In general Except as provided in this section, the Administrator shall not disclose information that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b)(4) of that section— (1) that is reported to, or otherwise obtained by, the Administrator under this Act; and (2) for which the requirements of subsection (c) are met. In any proceeding under section 552(a) of title 5, United States Code, to obtain information the disclosure of which has been denied because of the provisions of this subsection, the Administrator may not rely on section 552(b)(3) of such title to sustain the Administrator's action. (b) Information not protected from disclosure (1) Mixed confidential and nonconfidential information Information that is protected from disclosure under this section, and which is mixed with information that is not protected from disclosure under this section, does not lose its protection from disclosure notwithstanding that it is mixed with information that is not protected from disclosure. (2) Information from health and safety studies Subsection (a) does not prohibit the disclosure of— (A) any health and safety study which is submitted under this Act with respect to— (i) any chemical substance or mixture which, on the date on which such study is to be disclosed has been offered for commercial distribution; or (ii) any chemical substance or mixture for which testing is required under section 4 or for which notification is required under section 5; and (B) any information reported to, or otherwise obtained by, the Administrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subparagraph (A). This paragraph does not authorize the disclosure of any information, including formulas (including molecular structures) of a chemical substance or mixture, that discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture. (3) Other information not protected from disclosure Subsection (a) does not prohibit the disclosure of— (A) any general information describing the manufacturing volumes, expressed as specific aggregated volumes or, if the Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges; or (B) a general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector. (4) Bans and phase-outs (A) In general If the Administrator promulgates a rule pursuant to section 6(a) that establishes a ban or phase-out of a chemical substance or mixture, the protection from disclosure of any information under this section with respect to the chemical substance or mixture shall be presumed to no longer apply, subject to subsection (g)(1)(E) and subparagraphs (B) and (C) of this paragraph. (B) Limitations (i) Critical use In the case of a chemical substance or mixture for which a specific condition of use is subject to an exemption pursuant to section 6(g), if the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to information that relates solely to any conditions of use of the chemical substance or mixture to which the exemption does not apply. (ii) Export In the case of a chemical substance or mixture for which there is manufacture, processing, or distribution in commerce that meets the conditions of section 12(a)(1), if the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to information that relates solely to any other manufacture, processing, or distribution in commerce of the chemical substance or mixture for the conditions of use subject to the ban or phase-out, unless the Administrator makes the determination in section 12(a)(2). (iii) Specific conditions of use In the case of a chemical substance or mixture for which the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to a specific condition of use of the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to information that relates solely to the condition of use of the chemical substance or mixture for which the ban or phase-out is established. (C) Request for nondisclosure (i) In general A manufacturer or processor of a chemical substance or mixture subject to a ban or phase-out described in this paragraph may submit to the Administrator, within 30 days of receiving a notification under subsection (g)(2)(A), a request, including documentation supporting such request, that some or all of the information to which the notice applies should not be disclosed or that its disclosure should be delayed, and the Administrator shall review the request under subsection (g)(1)(E). (ii) Effect of no request or denial If no request for nondisclosure or delay is submitted to the Administrator under this subparagraph, or the Administrator denies such a request under subsection (g)(1)(A), the information shall not be protected from disclosure under this section. (5) Certain requests If a request is made to the Administrator under section 552(a) of title 5, United States Code, for information reported to or otherwise obtained by the Administrator under this Act that is not protected from disclosure under this subsection, the Administrator may not deny the request on the basis of section 552(b)(4) of title 5, United States Code. (c) Requirements for confidentiality claims (1) Assertion of claims (A) In general A person seeking to protect from disclosure any information that person submits under this Act (including information described in paragraph (2)) shall assert to the Administrator a claim for protection from disclosure concurrent with submission of the information, in accordance with such rules regarding a claim for protection from disclosure as the Administrator has promulgated or may promulgate pursuant to this title. (B) Inclusion An assertion of a claim under subparagraph (A) shall include a statement that the person has— (i) taken reasonable measures to protect the confidentiality of the information; (ii) determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (iii) a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and (iv) a reasonable basis to believe that the information is not readily discoverable through reverse engineering. (C) Additional requirements for claims regarding chemical identity information In the case of a claim under subparagraph (A) for protection from disclosure of a specific chemical identity, the claim shall include a structurally descriptive generic name for the chemical substance that the Administrator may disclose to the public, subject to the condition that such generic name shall— (i) be consistent with guidance developed by the Administrator under paragraph (4)(A); and (ii) describe the chemical structure of the chemical substance as specifically as practicable while protecting those features of the chemical structure— (I) that are claimed as confidential; and (II) the disclosure of which would be likely to cause substantial harm to the competitive position of the person. (2) Information generally not subject to substantiation requirements Subject to subsection (f), the following information shall not be subject to substantiation requirements under paragraph (3): (A) Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article. (B) Marketing and sales information. (C) Information identifying a supplier or customer. (D) In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents. (E) Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article. (F) Specific production or import volumes of the manufacturer or processor. (G) Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under section 5. (3) Substantiation requirements Except as provided in paragraph (2), a person asserting a claim to protect information from disclosure under this section shall substantiate the claim, in accordance with such rules as the Administrator has promulgated or may promulgate pursuant to this section. (4) Guidance The Administrator shall develop guidance regarding— (A) the determination of structurally descriptive generic names, in the case of claims for the protection from disclosure of specific chemical identity; and (B) the content and form of the statements of need and agreements required under paragraphs (4), (5), and (6) of subsection (d). (5) Certification An authorized official of a person described in paragraph (1)(A) shall certify that the statement required to assert a claim submitted pursuant to paragraph (1)(B), and any information required to substantiate a claim submitted pursuant to paragraph (3), are true and correct. (d) Exceptions to protection from disclosure Information described in subsection (a)— (1) shall be disclosed to an officer or employee of the United States— (A) in connection with the official duties of that person under any Federal law for the protection of health or the environment; or (B) for a specific Federal law enforcement purpose; (2) shall be disclosed to a contractor of the United States and employees of that contractor— (A) if, in the opinion of the Administrator, the disclosure is necessary for the satisfactory performance by the contractor of a contract with the United States for the performance of work in connection with this Act; and (B) subject to such conditions as the Administrator may specify; (3) shall be disclosed if the Administrator determines that disclosure is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use; (4) shall be disclosed to a State, political subdivision of a State, or tribal government, on written request, for the purpose of administration or enforcement of a law, if such entity has 1 or more applicable agreements with the Administrator that are consistent with the guidance developed under subsection (c)(4)(B) and ensure that the entity will take appropriate measures, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures comparable to the procedures used by the Administrator to safeguard the information; (5) shall be disclosed to a health or environmental professional employed by a Federal or State agency or tribal government or a treating physician or nurse in a nonemergency situation if such person provides a written statement of need and agrees to sign a written confidentiality agreement with the Administrator, subject to the conditions that— (A) the statement of need and confidentiality agreement are consistent with the guidance developed under subsection (c)(4)(B); (B) the statement of need shall be a statement that the person has a reasonable basis to suspect that— (i) the information is necessary for, or will assist in— (I) the diagnosis or treatment of 1 or more individuals; or (II) responding to an environmental release or exposure; and (ii) 1 or more individuals being diagnosed or treated have been exposed to the chemical substance or mixture concerned, or an environmental release of or exposure to the chemical substance or mixture concerned has occurred; and (C) the person will not use the information for any purpose other than the health or environmental needs asserted in the statement of need, except as otherwise may be authorized by the terms of the agreement or by the person who has a claim under this section with respect to the information; (6) shall be disclosed in the event of an emergency to a treating or responding physician, nurse, agent of a poison control center, public health or environmental official of a State, political subdivision of a State, or tribal government, or first responder (including any individual duly authorized by a Federal agency, State, political subdivision of a State, or tribal government who is trained in urgent medical care or other emergency procedures, including a police officer, firefighter, or emergency medical technician) if such person requests the information, subject to the conditions that such person shall— (A) have a reasonable basis to suspect that— (i) a medical, public health, or environmental emergency exists; (ii) the information is necessary for, or will assist in, emergency or first-aid diagnosis or treatment; or (iii) 1 or more individuals being diagnosed or treated have likely been exposed to the chemical substance or mixture concerned, or a serious environmental release of or exposure to the chemical substance or mixture concerned has occurred; and (B) if requested by a person who has a claim with respect to the information under this section— (i) provide a written statement of need and agree to sign a confidentiality agreement, as described in paragraph (5); and (ii) submit to the Administrator such statement of need and confidentiality agreement as soon as practicable, but not necessarily before the information is disclosed; (7) may be disclosed if the Administrator determines that disclosure is relevant in a proceeding under this Act, subject to the condition that the disclosure is made in such a manner as to preserve confidentiality to the extent practicable without impairing the proceeding; (8) shall be disclosed if the information is required to be made public under any other provision of Federal law; and (9) shall be disclosed as required pursuant to discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law. (e) Duration of protection from disclosure (1) In general Subject to paragraph (2), subsection (f)(3), and section 8(b), the Administrator shall protect from disclosure information described in subsection (a)— (A) in the case of information described in subsection (c)(2), until such time as— (i) the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the information shall not be protected from disclosure under this section; or (ii) the Administrator becomes aware that the information does not qualify for protection from disclosure under this section, in which case the Administrator shall take any actions required under subsections (f) and (g); and (B) in the case of information other than information described in subsection (c)(2)— (i) for a period of 10 years from the date on which the person asserts the claim with respect to the information submitted to the Administrator; or (ii) if applicable before the expiration of such 10-year period, until such time as— (I) the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the information shall not be protected from disclosure under this section; or (II) the Administrator becomes aware that the information does not qualify for protection from disclosure under this section, in which case the Administrator shall take any actions required under subsections (f) and (g). (2) Extensions (A) In general In the case of information other than information described in subsection (c)(2), not later than the date that is 60 days before the expiration of the period described in paragraph (1)(B)(i), the Administrator shall provide to the person that asserted the claim a notice of the impending expiration of the period. (B) Request (i) In general Not later than the date that is 30 days before the expiration of the period described in paragraph (1)(B)(i), a person reasserting the relevant claim shall submit to the Administrator a request for extension substantiating, in accordance with subsection (c)(3), the need to extend the period. (ii) Action by Administrator Not later than the date of expiration of the period described in paragraph (1)(B)(i), the Administrator shall, in accordance with subsection (g)(1)— (I) review the request submitted under clause (i); (II) make a determination regarding whether the claim for which the request was submitted continues to meet the relevant requirements of this section; and (III) (aa) grant an extension of 10 years; or (bb) deny the request. (C) No limit on number of extensions There shall be no limit on the number of extensions granted under this paragraph, if the Administrator determines that the relevant request under subparagraph (B)(i)— (i) establishes the need to extend the period; and (ii) meets the requirements established by the Administrator. (f) Review and resubstantiation (1) Discretion of Administrator The Administrator may require any person that has claimed protection for information from disclosure under this section, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , to reassert and substantiate or resubstantiate the claim in accordance with this section— (A) after the chemical substance is designated as a high-priority substance under section 6(b); (B) for any chemical substance designated as an active substance under section 8(b)(5)(B)(iii); or (C) if the Administrator determines that disclosure of certain information currently protected from disclosure would be important to assist the Administrator in conducting risk evaluations or promulgating rules under section 6. (2) Review required The Administrator shall review a claim for protection of information from disclosure under this section and require any person that has claimed protection for that information, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , to reassert and substantiate or resubstantiate the claim in accordance with this section— (A) as necessary to determine whether the information qualifies for an exemption from disclosure in connection with a request for information received by the Administrator under section 552 of title 5, United States Code; (B) if the Administrator has a reasonable basis to believe that the information does not qualify for protection from disclosure under this section; or (C) for any chemical substance the Administrator determines under section 6(b)(4)(A) presents an unreasonable risk of injury to health or the environment. (3) Period of protection If the Administrator requires a person to reassert and substantiate or resubstantiate a claim under this subsection, and determines that the claim continues to meet the relevant requirements of this section, the Administrator shall protect the information subject to the claim from disclosure for a period of 10 years from the date of such determination, subject to any subsequent requirement by the Administrator under this subsection. (g) Duties of Administrator (1) Determination (A) In general Except for claims regarding information described in subsection (c)(2), the Administrator shall, subject to subparagraph (C), not later than 90 days after the receipt of a claim under subsection (c), and not later than 30 days after the receipt of a request for extension of a claim under subsection (e) or a request under subsection (b)(4)(C), review and approve, approve in part and deny in part, or deny the claim or request. (B) Reasons for denial If the Administrator denies or denies in part a claim or request under subparagraph (A) the Administrator shall provide to the person that asserted the claim or submitted the request a written statement of the reasons for the denial or denial in part of the claim or request. (C) Subsets The Administrator shall— (i) except with respect to information described in subsection (c)(2)(G), review all claims or requests under this section for the protection from disclosure of the specific chemical identity of a chemical substance; and (ii) review a representative subset, comprising at least 25 percent, of all other claims or requests for protection from disclosure under this section. (D) Effect of failure to act The failure of the Administrator to make a decision regarding a claim or request for protection from disclosure or extension under this section shall not have the effect of denying or eliminating a claim or request for protection from disclosure. (E) Determination of requests under subsection ( b )( 4 )( C ) With respect to a request submitted under subsection (b)(4)(C), the Administrator shall, with the objective of ensuring that information relevant to the protection of health and the environment is disclosed to the extent practicable, determine whether the documentation provided by the person rebuts what shall be the presumption of the Administrator that the public interest in the disclosure of the information outweighs the public or proprietary interest in maintaining the protection for all or a portion of the information that the person has requested not be disclosed or for which disclosure be delayed. (2) Notification (A) In general Except as provided in subparagraph (B) and subsections (b), (d), and (e), if the Administrator denies or denies in part a claim or request under paragraph (1), concludes, in accordance with this section, that the information does not qualify for protection from disclosure, intends to disclose information pursuant to subsection (d), or promulgates a rule under section 6(a) establishing a ban or phase-out with respect to a chemical substance or mixture, the Administrator shall notify, in writing, the person that asserted the claim or submitted the request of the intent of the Administrator to disclose the information or not protect the information from disclosure under this section. The notice shall be furnished by certified mail (return receipt requested), by personal delivery, or by other means that allows verification of the fact and date of receipt. (B) Disclosure of information Except as provided in subparagraph (C), the Administrator shall not disclose information under this subsection until the date that is 30 days after the date on which the person that asserted the claim or submitted the request receives notification under subparagraph (A). (C) Exceptions (i) Fifteen day notification For information the Administrator intends to disclose under subsections (d)(3), (d)(4), (d)(5), and (j), the Administrator shall not disclose the information until the date that is 15 days after the date on which the person that asserted the claim or submitted the request receives notification under subparagraph (A), except that, with respect to information to be disclosed under subsection (d)(3), if the Administrator determines that disclosure of the information is necessary to protect against an imminent and substantial harm to health or the environment, no prior notification shall be necessary. (ii) Notification as soon as practicable For information the Administrator intends to disclose under paragraph (6) of subsection (d), the Administrator shall notify the person that submitted the information that the information has been disclosed as soon as practicable after disclosure of the information. (iii) No notification required Notification shall not be required— (I) for the disclosure of information under paragraphs (1), (2), (7), or (8) of subsection (d); or (II) for the disclosure of information for which— (aa) the Administrator has provided to the person that asserted the claim a notice under subsection (e)(2)(A); and (bb) such person does not submit to the Administrator a request under subsection (e)(2)(B) on or before the deadline established in subsection (e)(2)(B)(i). (D) Appeals (i) Action to restrain disclosure If a person receives a notification under this paragraph and believes the information is protected from disclosure under this section, before the date on which the information is to be disclosed pursuant to subparagraph (B) or (C) the person may bring an action to restrain disclosure of the information in— (I) the United States district court of the district in which the complainant resides or has the principal place of business; or (II) the United States District Court for the District of Columbia. (ii) No disclosure (I) In general Subject to subsection (d), the Administrator shall not disclose information that is the subject of an appeal under this paragraph before the date on which the applicable court rules on an action under clause (i). (II) Exception Subclause (I) shall not apply to disclosure of information described under subsections (d)(4) and (j). (3) Request and notification system The Administrator, in consultation with the Director of the Centers for Disease Control and Prevention, shall develop a request and notification system that, in a format and language that is readily accessible and understandable, allows for expedient and swift access to information disclosed pursuant to paragraphs (5) and (6) of subsection (d). (4) Unique identifier The Administrator shall— (A) (i) develop a system to assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure, which shall not be either the specific chemical identity or a structurally descriptive generic term; and (ii) apply that identifier consistently to all information relevant to the applicable chemical substance; (B) annually publish and update a list of chemical substances, referred to by their unique identifiers, for which claims to protect the specific chemical identity from disclosure have been approved, including the expiration date for each such claim; (C) ensure that any nonconfidential information received by the Administrator with respect to a chemical substance included on the list published under subparagraph (B) while the specific chemical identity of the chemical substance is protected from disclosure under this section identifies the chemical substance using the unique identifier; and (D) for each claim for protection of a specific chemical identity that has been denied by the Administrator or expired, or that has been withdrawn by the person who asserted the claim, and for which the Administrator has used a unique identifier assigned under this paragraph to protect the specific chemical identity in information that the Administrator has made public, clearly link the specific chemical identity to the unique identifier in such information to the extent practicable. (h) Criminal penalty for wrongful disclosure (1) Individuals subject to penalty (A) In general Subject to subparagraph (C) and paragraph (2), an individual described in subparagraph (B) shall be fined under title 18, United States Code, or imprisoned for not more than 1 year, or both. (B) Description An individual referred to in subparagraph (A) is an individual who— (i) pursuant to this section, obtained possession of, or has access to, information protected from disclosure under this section; and (ii) knowing that the information is protected from disclosure under this section, willfully discloses the information in any manner to any person not entitled to receive that information. (C) Exception This paragraph shall not apply to any medical professional (including an emergency medical technician or other first responder) who discloses any information obtained under paragraph (5) or (6) of subsection (d) to a patient treated by the medical professional, or to a person authorized to make medical or health care decisions on behalf of such a patient, as needed for the diagnosis or treatment of the patient. (2) Other laws Section 1905 of title 18, United States Code, shall not apply with respect to the publishing, divulging, disclosure, or making known of, or making available, information reported to or otherwise obtained by the Administrator under this Act. (i) Applicability (1) In general Except as otherwise provided in this section, section 8, or any other applicable Federal law, the Administrator shall have no authority— (A) to require the substantiation or resubstantiation of a claim for the protection from disclosure of information reported to or otherwise obtained by the Administrator under this Act prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ; or (B) to impose substantiation or resubstantiation requirements, with respect to the protection of information described in subsection (a), under this Act that are more extensive than those required under this section. (2) Actions prior to promulgation of rules Nothing in this Act prevents the Administrator from reviewing, requiring substantiation or resubstantiation of, or approving, approving in part, or denying any claim for the protection from disclosure of information before the effective date of such rules applicable to those claims as the Administrator may promulgate after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (j) Access by Congress Notwithstanding any limitation contained in this section or any other provision of law, all information reported to or otherwise obtained by the Administrator (or any representative of the Administrator) under this Act shall be made available, upon written request of any duly authorized committee of the Congress, to such committee. . 12. Penalties Section 16 of the Toxic Substances Control Act ( 15 U.S.C. 2615 ) is amended— (1) in subsection (a)(1), by striking $25,000 and inserting $37,500 ; and (2) in subsection (b)— (A) by striking Any person and inserting the following: (1) In general Any person ; (B) by striking $25,000 and inserting $50,000 ; and (C) by adding at the end the following: (2) Imminent danger of death or serious bodily injury (A) In general Any person who knowingly and willfully violates any provision of section 15 or 409, and who knows at the time of the violation that the violation places an individual in imminent danger of death or serious bodily injury, shall be subject on conviction to a fine of not more than $250,000, or imprisonment for not more than 15 years, or both. (B) Organizations Notwithstanding the penalties described in subparagraph (A), an organization that commits a knowing violation described in subparagraph (A) shall be subject on conviction to a fine of not more than $1,000,000 for each violation. (C) Incorporation of corresponding provisions Subparagraphs (B) through (F) of section 113(c)(5) of the Clean Air Act ( 42 U.S.C. 7413(c)(5)(B) –(F)) shall apply to the prosecution of a violation under this paragraph. . 13. State-Federal relationship Section 18 of the Toxic Substances Control Act ( 15 U.S.C. 2617 ) is amended— (1) by amending subsection (a) to read as follows: (a) In general (1) Establishment or enforcement Except as otherwise provided in subsections (c), (d), (e), (f), and (g), and subject to paragraph (2), no State or political subdivision of a State may establish or continue to enforce any of the following: (A) Development of information A statute or administrative action to require the development of information about a chemical substance or category of chemical substances that is reasonably likely to produce the same information required under section 4, 5, or 6 in— (i) a rule promulgated by the Administrator; (ii) a consent agreement entered into by the Administrator; or (iii) an order issued by the Administrator. (B) Chemical substances found not to present an unreasonable risk or restricted A statute, criminal penalty, or administrative action to prohibit or otherwise restrict the manufacture, processing, or distribution in commerce or use of a chemical substance— (i) for which the determination described in section 6(i)(1) is made, consistent with the scope of the risk evaluation under section (6)(b)(4)(D); or (ii) for which a final rule is promulgated under section 6(a), after the effective date of the rule issued under section 6(a) for the chemical substance, consistent with the scope of the risk evaluation under section (6)(b)(4)(D). (C) Significant new use A statute or administrative action requiring the notification of a use of a chemical substance that the Administrator has specified as a significant new use and for which the Administrator has required notification pursuant to a rule promulgated under section 5. (2) Effective date of preemption Under this subsection, Federal preemption of statutes and administrative actions applicable to specific chemical substances shall not occur until the effective date of the applicable action described in paragraph (1) taken by the Administrator. ; (2) by amending subsection (b) to read as follows: (b) New statutes, criminal penalties, or administrative actions creating prohibitions or other restrictions (1) In general Except as provided in subsections (c), (d), (e), (f), and (g), beginning on the date on which the Administrator defines the scope of a risk evaluation for a chemical substance under section 6(b)(4)(D) and ending on the date on which the deadline established pursuant to section 6(b)(4)(G) for completion of the risk evaluation expires, or on the date on which the Administrator publishes the risk evaluation under section 6(b)(4)(C), whichever is earlier, no State or political subdivision of a State may establish a statute, criminal penalty, or administrative action prohibiting or otherwise restricting the manufacture, processing, distribution in commerce, or use of such chemical substance that is a high-priority substance designated under section 6(b)(1)(B)(i). (2) Effect of subsection This subsection does not restrict the authority of a State or political subdivision of a State to continue to enforce any statute enacted, criminal penalty assessed, or administrative action taken, prior to the date on which the Administrator defines and publishes the scope of a risk evaluation under section 6(b)(4)(D). ; and (3) by adding at the end the following: (c) Scope of preemption Federal preemption under subsections (a) and (b) of statutes, criminal penalties, and administrative actions applicable to specific chemical substances shall apply only to— (1) with respect to subsection (a)(1)(A), the chemical substances or category of chemical substances subject to a rule, order, or consent agreement under section 4, 5, or 6; (2) with respect to subsection (b), the hazards, exposures, risks, and uses or conditions of use of such chemical substances included in the scope of the risk evaluation pursuant to section 6(b)(4)(D); (3) with respect to subsection (a)(1)(B), the hazards, exposures, risks, and uses or conditions of use of such chemical substances included in any final action the Administrator takes pursuant to section 6(a) or 6(i)(1); or (4) with respect to subsection (a)(1)(C), the uses of such chemical substances that the Administrator has specified as significant new uses and for which the Administrator has required notification pursuant to a rule promulgated under section 5. (d) Exceptions (1) No preemption of statutes and administrative actions (A) In general Nothing in this Act, nor any amendment made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act , nor any rule, standard of performance, risk evaluation, or scientific assessment implemented pursuant to this Act, shall affect the right of a State or a political subdivision of a State to adopt or enforce any rule, standard of performance, risk evaluation, scientific assessment, or any other protection for public health or the environment that— (i) is adopted or authorized under the authority of any other Federal law or adopted to satisfy or obtain authorization or approval under any other Federal law; (ii) implements a reporting, monitoring, or other information obligation for the chemical substance not otherwise required by the Administrator under this Act or required under any other Federal law; (iii) is adopted pursuant to authority under a law of the State or political subdivision of the State related to water quality, air quality, or waste treatment or disposal, except to the extent that the action— (I) imposes a restriction on the manufacture, processing, distribution in commerce, or use of a chemical substance; and (II) (aa) addresses the same hazards and exposures, with respect to the same conditions of use as are included in the scope of the risk evaluation published pursuant to section 6(b)(4)(D), but is inconsistent with the action of the Administrator; or (bb) would cause a violation of the applicable action by the Administrator under section 5 or 6; or (iv) subject to subparagraph (B), is identical to a requirement prescribed by the Administrator. (B) Identical requirements (i) In general The penalties and other sanctions applicable under a law of a State or political subdivision of a State in the event of noncompliance with the identical requirement shall be no more stringent than the penalties and other sanctions available to the Administrator under section 16 of this Act. (ii) Penalties In the case of an identical requirement— (I) a State or political subdivision of a State may not assess a penalty for a specific violation for which the Administrator has assessed an adequate penalty under section 16; and (II) if a State or political subdivision of a State has assessed a penalty for a specific violation, the Administrator 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 or political subdivision of a State and the Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16. (2) Applicability to certain rules or orders (A) Prior rules and orders Nothing in this section shall be construed as modifying the preemptive effect under this section, as in effect on the day before the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , of any rule or order promulgated or issued under this Act prior to that effective date. (B) Certain chemical substances and mixtures With respect to a chemical substance or mixture for which any rule or order was promulgated or issued under section 6 prior to the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with respect to manufacturing, processing, distribution in commerce, use, or disposal of the chemical substance or mixture, nothing in this section shall be construed as modifying the preemptive effect of this section as in effect prior to the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act of any rule or order that is promulgated or issued with respect to such chemical substance or mixture under section 6 after that effective date, unless the latter rule or order is with respect to a chemical substance or mixture containing a chemical substance and follows a designation of that chemical substance as a high-priority substance under section 6(b)(1)(B)(i), the identification of that chemical substance under section 6(b)(2)(A), or the selection of that chemical substance for risk evaluation under section 6(b)(4)(E)(iv)(II). (e) Preservation of certain laws (1) In general Nothing in this Act, subject to subsection (g) of this section, shall— (A) be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken or requirement imposed or requirement enacted relating to a specific chemical substance before April 22, 2016, under the authority of a law of the State or political subdivision of the State that prohibits or otherwise restricts manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or (B) be construed to preempt or otherwise affect any action taken pursuant to a State law that was in effect on August 31, 2003. (2) Effect of subsection This subsection does not affect, modify, or alter the relationship between Federal law and laws of a State or political subdivision of a State pursuant to any other Federal law. (f) Waivers (1) Discretionary exemptions Upon application of a State or political subdivision of a State, the Administrator may, by rule, exempt from subsection (a), under such conditions as may be prescribed in the rule, a statute, criminal penalty, or administrative action of that State or political subdivision of the State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that— (A) compelling conditions warrant granting the waiver to protect health or the environment; (B) compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; (C) compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and (D) in the judgment of the Administrator, the proposed requirement of the State or political subdivision of the State is designed to address a risk of a chemical substance, under the conditions of use, that was identified— (i) consistent with the best available science; (ii) using supporting studies conducted in accordance with sound and objective scientific practices; and (iii) based on the weight of the scientific evidence. (2) Required exemptions Upon application of a State or political subdivision of a State, the Administrator shall exempt from subsection (b) a statute or administrative action of a State or political subdivision of a State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that— (A) (i) compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; (ii) compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and (iii) the State or political subdivision of the State has a concern about the chemical substance or use of the chemical substance based in peer-reviewed science; or (B) no later than the date that is 18 months after the date on which the Administrator has initiated the prioritization process for a chemical substance under the rule promulgated pursuant to section 6(b)(1)(A), or the date on which the Administrator publishes the scope of the risk evaluation for a chemical substance under section 6(b)(4)(D), whichever is sooner, the State or political subdivision of the State has enacted a statute or proposed or finalized an administrative action intended to prohibit or otherwise restrict the manufacture, processing, distribution in commerce, or use of the chemical substance. (3) Determination of a waiver request The duty of the Administrator to grant or deny a waiver application shall be nondelegable and shall be exercised— (A) not later than 180 days after the date on which an application under paragraph (1) is submitted; and (B) not later than 110 days after the date on which an application under paragraph (2) is submitted. (4) Failure to make a determination If the Administrator fails to make a determination under paragraph (3)(B) during the 110-day period beginning on the date on which an application under paragraph (2) is submitted, the statute or administrative action of the State or political subdivision of the State that was the subject of the application shall not be considered to be an existing statute or administrative action for purposes of subsection (b) by reason of the failure of the Administrator to make a determination. (5) Notice and comment Except in the case of an application approved under paragraph (9), the application of a State or political subdivision of a State under this subsection shall be subject to public notice and comment. (6) Final agency action The decision of the Administrator on the application of a State or political subdivision of a State shall be— (A) considered to be a final agency action; and (B) subject to judicial review. (7) Duration of waivers A waiver granted under paragraph (2) or approved under paragraph (9) shall remain in effect until such time as the Administrator publishes the risk evaluation under section 6(b). (8) Judicial review of waivers Not later than 60 days after the date on which the Administrator makes a determination on an application of a State or political subdivision of a State under paragraph (1) or (2), any person may file a petition for judicial review in the United States Court of Appeals for the District of Columbia Circuit, which shall have exclusive jurisdiction over the determination. (9) Approval (A) Automatic approval If the Administrator fails to meet the deadline established under paragraph (3)(B), the application of a State or political subdivision of a State under paragraph (2) shall be automatically approved, effective on the date that is 10 days after the deadline. (B) Requirements Notwithstanding paragraph (6), approval of a waiver application under subparagraph (A) for failure to meet the deadline under paragraph (3)(B) shall not be considered final agency action or be subject to judicial review or public notice and comment. (g) Savings (1) No preemption of common law or statutory causes of action for civil relief or criminal conduct (A) In general Nothing in this Act, nor any amendment made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act , nor any standard, rule, requirement, standard of performance, risk evaluation, or scientific assessment implemented pursuant to this Act, shall be construed to preempt, displace, or supplant any State or Federal common law rights or any State or Federal statute creating a remedy for civil relief, including those for civil damage, or a penalty for a criminal conduct. (B) Clarification of no preemption Notwithstanding any other provision of this Act, nothing in this Act, nor any amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act , shall preempt or preclude any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory of liability under any State law, maritime law, or Federal common law or statutory theory. (2) No effect on private remedies (A) In general Nothing in this Act, nor any amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act , nor any rules, regulations, requirements, risk evaluations, scientific assessments, or orders issued pursuant to this Act shall be interpreted as, in either the plaintiff’s or defendant’s favor, dispositive in any civil action. (B) Authority of courts This Act does not affect the authority of any court to make a determination in an adjudicatory proceeding under applicable State or Federal law with respect to the admission into evidence or any other use of this Act or rules, regulations, requirements, standards of performance, risk evaluations, scientific assessments, or orders issued pursuant to this Act. . 14. Judicial review Section 19(a) of the Toxic Substances Control Act ( 15 U.S.C. 2618(a) ) is amended— (1) in paragraph (1), by adding at the end the following: (C) (i) Not later than 60 days after the publication of a designation under section 6(b)(1)(B)(ii), any person may commence a civil action to challenge the designation. (ii) The United States Court of Appeals for the District of Columbia Circuit shall have exclusive jurisdiction over a civil action filed under this subparagraph. ; and (2) by striking paragraph (3). 15. Citizens’ civil actions Section 20(b) of the Toxic Substances Control Act ( 15 U.S.C. 2619(b) ) is amended— (1) in paragraph (1)(B), by striking or at the end; and (2) in paragraph (2), by striking the period at the end and inserting the following: , except that no prior notification shall be required in the case of a civil action brought to compel a decision by the Administrator pursuant to section 18(f)(3)(B); or (3) in the case of a civil action brought to compel a decision by the Administrator pursuant to section 18(f)(3)(B), after the date that is 60 days after the deadline specified in section 18(f)(3)(B). . 16. Studies Section 25 of the Toxic Substances Control Act ( 15 U.S.C. 2624 ) is repealed. 17. Administration of the Act Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) in subsection (b)(1)— (A) by striking of a reasonable fee ; (B) by striking data under section 4 or 5 to defray the cost of administering this Act and inserting information under section 4 or a notice or other information to be reviewed by the Administrator under section 5, or who manufactures or processes a chemical substance that is the subject of a risk evaluation under section 6(b), of a fee that is sufficient and not more than reasonably necessary to defray the cost related to such chemical substance of administering sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, including contractor costs incurred by the Administrator ; (C) by striking Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. ; and (D) by striking submit the data and the cost to the Administrator of reviewing such data and inserting pay such fee and the cost to the Administrator of carrying out the activities described in this paragraph ; (2) in subsection (b)— (A) in paragraph (2), by striking paragraph (1) and inserting paragraph (4) ; and (B) by adding at the end the following: (3) Fund (A) Establishment There is established in the Treasury of the United States a fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the Fund ), consisting of such amounts as are deposited in the Fund under this paragraph. (B) Collection and deposit of fees Subject to the conditions of subparagraph (C), the Administrator shall collect the fees described in this subsection and deposit those fees in the Fund. (C) Use of funds by Administrator Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation for use in defraying the costs of the activities described in paragraph (1). (D) Accounting and auditing (i) Accounting The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code. (ii) Auditing (I) In general For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency. (II) Components of audit The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of— (aa) the fees collected and amounts disbursed under this subsection; (bb) the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of this title for which the fees may be used; and (cc) the number of requests for a risk evaluation made by manufacturers under section 6(b)(4)(C)(ii). (III) Federal responsibility The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit. (4) Amount and adjustment of fees; refunds In setting fees under this section, the Administrator shall— (A) prescribe lower fees for small business concerns, after consultation with the Administrator of the Small Business Administration; (B) set the fees established under paragraph (1) at levels such that the fees will, in aggregate, provide a sustainable source of funds to annually defray— (i) the lower of— (I) 25 percent of the costs to the Administrator of carrying out sections 4, 5, and 6, and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, other than the costs to conduct and complete risk evaluations under section 6(b); or (II) $25,000,000 (subject to adjustment pursuant to subparagraph (F)); and (ii) the costs of risk evaluations specified in subparagraph (D); (C) reflect an appropriate balance in the assessment of fees between manufacturers and processors, and allow the payment of fees by consortia of manufacturers or processors; (D) notwithstanding subparagraph (B)— (i) except as provided in clause (ii), for chemical substances for which the Administrator has granted a request from a manufacturer pursuant to section 6(b)(4)(C)(ii), establish the fee at a level sufficient to defray the full costs to the Administrator of conducting the risk evaluation under section 6(b); (ii) for chemical substances for which the Administrator has granted a request from a manufacturer pursuant to section 6(b)(4)(C)(ii), and which are included in the 2014 update of the TSCA Work Plan for Chemical Assessments, establish the fee at a level sufficient to defray 50 percent of the costs to the Administrator of conducting the risk evaluation under section 6(b); and (iii) apply fees collected pursuant to clauses (i) and (ii) only to defray the costs described in those clauses; (E) prior to the establishment or amendment of any fees under paragraph (1), consult and meet with parties potentially subject to the fees or their representatives, subject to the condition that no obligation under the Federal Advisory Committee Act (5 U.S.C. App.) or subchapter II of chapter 5 of title 5, United States Code, is applicable with respect to such meetings; (F) beginning with the fiscal year that is 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and every 3 years thereafter, after consultation with parties potentially subject to the fees and their representatives pursuant to subparagraph (E), increase or decrease the fees established under paragraph (1) as necessary to adjust for inflation and to ensure that funds deposited in the Fund are sufficient to defray— (i) approximately but not more than 25 percent of the costs to the Administrator of carrying out sections 4, 5, and 6, and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, other than the costs to conduct and complete risk evaluations requested under section 6(b)(4)(C)(ii); and (ii) the costs of risk evaluations specified in subparagraph (D); and (G) if a notice submitted under section 5 is not reviewed or such a notice is withdrawn, refund the fee or a portion of the fee if no substantial work was performed on the notice. (5) Minimum amount of appropriations Fees may not be assessed for a fiscal year under this section unless the amount of appropriations for the Chemical Risk Review and Reduction program project of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for that program project for fiscal year 2014. (6) Termination The authority provided by this subsection shall terminate at the conclusion of the fiscal year that is 10 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act unless otherwise reauthorized or modified by Congress. ; and (3) by adding at the end the following: (h) Scientific standards In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science, and shall consider as applicable— (1) the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information; (2) the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and (5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models. (i) Weight of scientific evidence The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence. (j) Availability of information Subject to section 14, the Administrator shall make available to the public— (1) all notices, determinations, findings, rules, consent agreements, and orders of the Administrator under this title; (2) any information required to be provided to the Administrator under section 4; (3) a nontechnical summary of each risk evaluation conducted under section 6(b); (4) a list of the studies considered by the Administrator in carrying out each such risk evaluation, along with the results of those studies; and (5) each designation of a chemical substance under section 6(b), along with an identification of the information, analysis, and basis used to make the designations. (k) Reasonably available information In carrying out sections 4, 5, and 6, the Administrator shall take into consideration information relating to a chemical substance or mixture, including hazard and exposure information, under the conditions of use, that is reasonably available to the Administrator. (l) Policies, procedures, and guidance (1) Development Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (2) Review Not later than 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and not less frequently than once every 5 years thereafter, the Administrator shall— (A) review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and (B) revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings. (3) Testing of Chemical Substances and Mixtures The policies, procedures, and guidance developed under paragraph (1) applicable to testing chemical substances and mixtures shall— (A) address how and when the exposure level or exposure potential of a chemical substance or mixture would factor into decisions to require new testing, subject to the condition that the Administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential; and (B) describe the manner in which the Administrator will determine that additional information is necessary to carry out this title, including information relating to potentially exposed or susceptible populations. (4) Chemical substances with completed risk assessments With respect to a chemical substance listed in the 2014 update to the TSCA Work Plan for Chemical Assessments for which the Administrator has published a completed risk assessment prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator may publish proposed and final rules under section 6(a) that are consistent with the scope of the completed risk assessment for the chemical substance and consistent with other applicable requirements of section 6. (5) Guidance Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator. The guidance shall, at a minimum, address the quality of the information submitted and the process to be followed in developing draft risk evaluations for consideration by the Administrator. (m) Report to Congress (1) Initial report Not later than 6 months after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of— (A) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(i), and the resources necessary to conduct the minimum number of risk evaluations required under section 6(b)(2); (B) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand; (C) the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and (D) the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b). (2) Subsequent reports The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years. (n) Annual plan (1) In general The Administrator shall inform the public regarding the schedule and the resources necessary for the completion of each risk evaluation as soon as practicable after initiating the risk evaluation. (2) Publication of plan At the beginning of each calendar year, the Administrator shall publish an annual plan that— (A) identifies the chemical substances for which risk evaluations are expected to be initiated or completed that year and the resources necessary for their completion; (B) describes the status of each risk evaluation that has been initiated but not yet completed; and (C) if the schedule for completion of a risk evaluation has changed, includes an updated schedule for that risk evaluation. (o) Consultation with science advisory committee on chemicals (1) Establishment Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall establish an advisory committee, to be known as the Science Advisory Committee on Chemicals (referred to in this subsection as the Committee ). (2) Purpose The purpose of the Committee shall be to provide independent advice and expert consultation, at the request of the Administrator, with respect to the scientific and technical aspects of issues relating to the implementation of this title. (3) Composition The Committee shall be composed of representatives of such science, government, labor, public health, public interest, animal protection, industry, and other groups as the Administrator determines to be advisable, including representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations. (4) Schedule The Administrator shall convene the Committee in accordance with such schedule as the Administrator determines to be appropriate, but not less frequently than once every 2 years. (p) Prior actions (1) Rules, orders, and exemptions Nothing in the Frank R. Lautenberg Chemical Safety for the 21st Century Act eliminates, modifies, or withdraws any rule promulgated, order issued, or exemption established pursuant to this Act before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (2) Prior-initiated evaluations Nothing in this Act prevents the Administrator from initiating a risk evaluation regarding a chemical substance, or from continuing or completing such risk evaluation, prior to the effective date of the policies, procedures, and guidance required to be developed by the Administrator pursuant to the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (3) Actions completed prior to completion of policies, procedures, and guidance Nothing in this Act requires the Administrator to revise or withdraw a completed risk evaluation, determination, or rule under this Act solely because the action was completed prior to the development of a policy, procedure, or guidance pursuant to the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act . . 18. State programs Section 28 of the Toxic Substances Control Act ( 15 U.S.C. 2627 ) is amended by striking subsections (c) and (d). 19. Conforming amendments (a) Table of contents The table of contents in section 1 of the Toxic Substances Control Act is amended— (1) by striking the item relating to section 6 and inserting the following: Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances and mixtures. ; (2) by striking the item relating to section 10 and inserting the following: Sec. 10. Research, development, collection, dissemination, and utilization of information. ; (3) by striking the item relating to section 14 and inserting the following: Sec. 14. Confidential information. ; and (4) by striking the item relating to section 25. (b) Section 2 Section 2(b)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2601(b)(1) ) is amended by striking data both places it appears and inserting information . (c) Section 3 Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) in paragraph (8) (as redesignated by section 3 of this Act), by striking data and inserting information ; and (2) in paragraph (15) (as redesignated by section 3 of this Act)— (A) by striking standards and inserting protocols and methodologies ; (B) by striking test data both places it appears and inserting information ; and (C) by striking data each place it appears and inserting information . (d) Section 4 Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (b)— (A) in paragraph (1)— (i) in the paragraph heading, by adding , order, or consent agreement at the end; and (ii) by striking rule each place it appears and inserting rule, order, or consent agreement ; (B) in paragraph (2)(B), by striking rules and inserting rules, orders, and consent agreements ; (C) in paragraph (3)(A), by striking rule and inserting rule or order ; and (D) in paragraph (4)— (i) by striking rule under subsection (a) each place it appears and inserting rule, order, or consent agreement under subsection (a) ; (ii) by striking repeals the rule each place it appears and inserting repeals the rule or order or modifies the consent agreement to terminate the requirement ; and (iii) by striking repeals the application of the rule and inserting repeals or modifies the application of the rule, order, or consent agreement ; (2) in subsection (c)— (A) in paragraph (1), by striking rule and inserting rule or order ; (B) in paragraph (2)— (i) in subparagraph (A), by striking a rule under subsection (a) or for which data is being developed pursuant to such a rule and inserting a rule, order, or consent agreement under subsection (a) or for which information is being developed pursuant to such a rule, order, or consent agreement ; (ii) in subparagraph (B), by striking such rule or which is being developed pursuant to such rule and inserting such rule, order, or consent agreement or which is being developed pursuant to such rule, order, or consent agreement ; and (iii) in the matter following subparagraph (B), by striking the rule and inserting the rule or order ; (C) in paragraph (3)(B)(i), by striking rule promulgated and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule promulgated each place it appears and inserting rule, order, or consent agreement ; (ii) by striking such rule each place it appears and inserting such rule, order, or consent agreement ; and (iii) in subparagraph (B), by striking the rule and inserting the rule or order ; (3) in subsection (d), by striking rule and inserting rule, order, or consent agreement ; and (4) in subsection (g), by striking rule and inserting rule, order, or consent agreement . (e) Section 5 Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) in subsection (b)— (A) in paragraph (1)(A)— (i) by striking rule promulgated and inserting rule, order, or consent agreement ; and (ii) by striking such rule and inserting such rule, order, or consent agreement ; (B) in paragraph (1)(B), by striking rule promulgated and inserting rule or order ; and (C) in paragraph (2)(A)(ii), by striking rule promulgated and inserting rule, order, or consent agreement ; and (2) in subsection (d)(2)(C), by striking rule and inserting rule, order, or consent agreement . (f) Section 7 Section 7(a) of the Toxic Substances Control Act ( 15 U.S.C. 2606(a) ) is amended— (1) in paragraph (1), in the matter following subparagraph (C), by striking a rule under section 4, 5, 6, or title IV or an order under section 5 or title IV and inserting a determination under section 5 or 6, a rule under section 4, 5, or 6 or title IV, an order under section 4, 5, or 6 or title IV, or a consent agreement under section 4 ; and (2) in paragraph (2), by striking subsection 6(d)(2)(A)(i) and inserting section 6(d)(3)(A)(i) . (g) Section 8 Section 8(a) of the Toxic Substances Control Act ( 15 U.S.C. 2607(a) ) is amended— (1) in paragraph (2)(E), by striking data and inserting information ; and (2) in paragraph (3)(A)(ii)(I), by striking or an order in effect under section 5(e) and inserting , an order in effect under section 4 or 5(e), or a consent agreement under section 4 . (h) Section 9 Section 9 of the Toxic Substances Control Act ( 15 U.S.C. 2608 ) is amended— (1) in subsection (a), by striking section 6 each place it appears and inserting section 6(a) ; and (2) in subsection (d), by striking Health, Education, and Welfare and inserting Health and Human Services . (i) Section 10 Section 10 of the Toxic Substances Control Act ( 15 U.S.C. 2609 ) is amended— (1) in the section heading, by striking data and inserting information ; (2) by striking Health, Education, and Welfare each place it appears and inserting Health and Human Services ; (3) in subsection (b)— (A) in the subsection heading, by striking Data and inserting Information ; (B) by striking data and inserting information in paragraph (1); (C) by striking data and inserting information in paragraph (2)(A); and (D) by striking a data and inserting an information in paragraph (2)(B); and (4) in subsection (g), by striking data and inserting information . (j) Section 11 Section 11(b)(2) of the Toxic Substances Control Act ( 15 U.S.C. 2610(b)(2) ) is amended— (1) by striking data each place it appears and inserting information ; and (2) in subparagraph (E), by striking rule promulgated and inserting rule promulgated, order issued, or consent agreement entered into . (k) Section 12 Section 12(b)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2611(b)(1) ) is amended by striking data both places it appears and inserting information . (l) Section 15 Section 15(1) of the Toxic Substances Control Act ( 15 U.S.C. 2614(1) ) is amended by striking (A) any rule and all that follows through or (D) and inserting any requirement of this title or any rule promulgated, order issued, or consent agreement entered into under this title, or . (m) Section 19 Section 19 of the Toxic Substances Control Act ( 15 U.S.C. 2618 ) is amended— (1) in subsection (a)— (A) in paragraph (1)(A)— (i) by striking Not later than 60 days after the date of the promulgation of a rule under section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under title II or IV and inserting Except as otherwise provided in this title, not later than 60 days after the date on which a rule is promulgated under this title, title II, or title IV, or the date on which an order is issued under section 4, 5(e), 5(f), or 6(i)(1), ; (ii) by striking such rule and inserting such rule or order ; and (iii) by striking such a rule and inserting such a rule or order ; (B) in paragraph (1)(B)— (i) by striking Courts and inserting Except as otherwise provided in this title, courts ; and (ii) by striking subparagraph (A) or (B) of section 6(b)(1) and inserting this title, other than an order under section 4, 5(e), 5(f), or 6(i)(1), ; and (C) in paragraph (2)— (i) by striking rulemaking record and inserting record ; and (ii) by striking based the rule and inserting based the rule or order ; (2) in subsection (b)— (A) by striking review a rule and inserting review a rule, or an order under section 4, 5(e), 5(f), or 6(i)(1), ; (B) by striking such rule and inserting such rule or order ; (C) by striking the rule and inserting the rule or order ; (D) by striking new rule each place it appears and inserting new rule or order ; and (E) by striking modified rule and inserting modified rule or order ; and (3) in subsection (c)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking a rule and inserting a rule or order ; and (II) by striking such rule and inserting such rule or order ; (ii) in subparagraph (B)— (I) in the matter preceding clause (i), by striking a rule and inserting a rule or order ; (II) by amending clause (i) to read as follows: (i) in the case of review of— (I) a rule under section 4(a), 5(b)(4), 6(a) (including review of the associated determination under section 6(b)(4)(A)), or 6(e), the standard for review prescribed by paragraph (2)(E) of such section 706 shall not apply and the court shall hold unlawful and set aside such rule if the court finds that the rule is not supported by substantial evidence in the rulemaking record taken as a whole; and (II) an order under section 4, 5(e), 5(f), or 6(i)(1), the standard for review prescribed by paragraph (2)(E) of such section 706 shall not apply and the court shall hold unlawful and set aside such order if the court finds that the order is not supported by substantial evidence in the record taken as a whole; and ; and (III) by striking clauses (ii) and (iii) and the matter after clause (iii) and inserting the following: (ii) the court may not review the contents and adequacy of any statement of basis and purpose required by section 553(c) of title 5, United States Code, to be incorporated in the rule or order, except as part of the record, taken as a whole. ; and (iii) by striking subparagraph (C); and (B) in paragraph (2), by striking any rule and inserting any rule or order . (n) Section 20 Section 20(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2619(a)(1) ) is amended by striking order issued under section 5 and inserting order issued under section 4 or 5 . (o) Section 21 Section 21 of the Toxic Substances Control Act ( 15 U.S.C. 2620 ) is amended— (1) in subsection (a), by striking order under section 5(e) or (6)(b)(2) and inserting order under section 4 or 5(e) or (f) ; and (2) in subsection (b)— (A) in paragraph (1), by striking order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B) and inserting order under section 4 or 5(e) or (f) ; and (B) in paragraph (4)(B)— (i) in the matter preceding clause (i), by striking order under section 5(e) or 6(b)(2) and inserting order under section 4 or 5(e) or (f) ; (ii) in clause (i), by striking order under section 5(e) and inserting order under section 4 or 5(e) ; and (iii) in clause (ii), by striking section 6 or 8 or an order under section 6(b)(2), there is a reasonable basis to conclude that the issuance of such a rule or order is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment and inserting section 6(a) or 8 or an order under section 5(f), the chemical substance or mixture to be subject to such rule or order presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use . (p) Section 24 Section 24(b)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2623(b)(2)(B) ) is amended— (1) by inserting and at the end of clause (i); (2) by striking clause (ii); and (3) by redesignating clause (iii) as clause (ii). (q) Section 26 Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) in subsection (e), by striking Health, Education, and Welfare each place it appears and inserting Health and Human Services ; and (2) in subsection (g)(1), by striking data and inserting information . (r) Section 27 Section 27(a) of the Toxic Substances Control Act ( 15 U.S.C. 2626(a) ) is amended— (1) by striking Health, Education, and Welfare and inserting Health and Human Services ; (2) by striking test data both places it appears and inserting information ; (3) by striking rules promulgated and inserting rules, orders, or consent agreements ; and (4) by striking standards and inserting protocols and methodologies . (s) Section 30 Section 30(2) of the Toxic Substances Control Act ( 15 U.S.C. 2629(2) ) is amended by striking rule and inserting rule, order, or consent agreement . 20. No retroactivity Nothing in sections 1 through 19, or the amendments made by sections 1 through 19, shall be interpreted to apply retroactively to any State, Federal, or maritime legal action filed before the date of enactment of this Act. 21. Trevor’s Law (a) Purposes The purposes of this section are— (1) to provide the appropriate Federal agencies with the authority to help conduct investigations into potential cancer clusters; (2) to ensure that Federal agencies have the authority to undertake actions to help address cancer clusters and factors that may contribute to the creation of potential cancer clusters; and (3) to enable Federal agencies to coordinate with other Federal, State, and local agencies, institutes of higher education, and the public in investigating and addressing cancer clusters. (b) Designation and investigation of potential cancer clusters Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. ) is amended by adding at the end the following: 399V–6. Designation and investigation of potential cancer clusters (a) Definitions In this section: (1) Cancer cluster The term cancer cluster means the incidence of a particular cancer within a population group, a geographical area, and a period of time that is greater than expected for such group, area, and period. (2) Particular cancer The term particular cancer means one specific type of cancer or a type of cancers scientifically proven to have the same cause. (3) Population group The term population group means a group, for purposes of calculating cancer rates, defined by factors such as race, ethnicity, age, or gender. (b) Criteria for designation of potential cancer clusters (1) Development of criteria The Secretary shall develop criteria for the designation of potential cancer clusters. (2) Requirements The criteria developed under paragraph (1) shall consider, as appropriate— (A) a standard for cancer cluster identification and reporting protocols used to determine when cancer incidence is greater than would be typically observed; (B) scientific screening standards that ensure that a cluster of a particular cancer involves the same type of cancer, or types of cancers; (C) the population in which the cluster of a particular cancer occurs by factors such as race, ethnicity, age, and gender, for purposes of calculating cancer rates; (D) the boundaries of a geographic area in which a cluster of a particular cancer occurs so as not to create or obscure a potential cluster by selection of a specific area; and (E) the time period over which the number of cases of a particular cancer, or the calculation of an expected number of cases, occurs. (c) Guidelines for investigation of potential cancer clusters The Secretary, in consultation with the Council of State and Territorial Epidemiologists and representatives of State and local health departments, shall develop, publish, and periodically update guidelines for investigating potential cancer clusters. The guidelines shall— (1) recommend that investigations of cancer clusters— (A) use the criteria developed under subsection (b); (B) use the best available science; and (C) rely on a weight of the scientific evidence; (2) provide standardized methods of reviewing and categorizing data, including from health surveillance systems and reports of potential cancer clusters; and (3) provide guidance for using appropriate epidemiological and other approaches for investigations. (d) Investigation of cancer clusters (1) Secretary discretion The Secretary— (A) in consultation with representatives of the relevant State and local health departments, shall consider whether it is appropriate to conduct an investigation of a potential cancer cluster; and (B) in conducting investigations shall have the discretion to prioritize certain potential cancer clusters, based on the availability of resources. (2) Coordination In investigating potential cancer clusters, the Secretary shall coordinate with agencies within the Department of Health and Human Services and other Federal agencies, such as the Environmental Protection Agency. (3) Biomonitoring In investigating potential cancer clusters, the Secretary shall rely on all appropriate biomonitoring information collected under other Federal programs, such as the National Health and Nutrition Examination Survey. The Secretary may provide technical assistance for relevant biomonitoring studies of other Federal agencies. (e) Duties The Secretary shall— (1) ensure that appropriate staff of agencies within the Department of Health and Human Services are prepared to provide timely assistance, to the extent practicable, upon receiving a request to investigate a potential cancer cluster from a State or local health authority; (2) maintain staff expertise in epidemiology, toxicology, data analysis, environmental health and cancer surveillance, exposure assessment, pediatric health, pollution control, community outreach, health education, laboratory sampling and analysis, spatial mapping, and informatics; (3) consult with community members as investigations into potential cancer clusters are conducted, as the Secretary determines appropriate; (4) collect, store, and disseminate reports on investigations of potential cancer clusters, the possible causes of such clusters, and the actions taken to address such clusters; and (5) provide technical assistance for investigating cancer clusters to State and local health departments through existing programs, such as the Epi-Aids program of the Centers for Disease Control and Prevention and the Assessments of Chemical Exposures Program of the Agency for Toxic Substances and Disease Registry. . II Rural Healthcare Connectivity 201. Short title This title may be cited as the Rural Healthcare Connectivity Act of 2016 . 202. Telecommunications services for skilled nursing facilities (a) In general Section 254(h)(7)(B) of the Communications Act of 1934 ( 47 U.S.C. 254(h)(7)(B) ) is amended— (1) in clause (vi), by striking and at the end; (2) by redesignating clause (vii) as clause (viii); (3) by inserting after clause (vi) the following: (vii) skilled nursing facilities (as defined in section 1819(a) of the Social Security Act ( 42 U.S.C. 1395i–3(a) )); and ; and (4) in clause (viii), as redesignated, by striking clauses (i) through (vi) and inserting clauses (i) through (vii) . (b) Savings clause Nothing in subsection (a) shall be construed to affect the aggregate annual cap on Federal universal service support for health care providers under section 54.675 of title 47, Code of Federal Regulations, or any successor regulation. (c) Effective date The amendments made by subsection (a) shall apply beginning on the date that is 180 days after the date of the enactment of this Act.

Karen L. Haas Clerk.

tv_txt: I One Hundred Fourteenth Congress of the United States of America At the Second Session Begun and held at the City of Washington on Monday, the fourth day of January, two thousand and sixteen H. R. 2576 AN ACT To modernize the Toxic Substances Control Act, and for other purposes.

1. Short title; table of contents (a) Short title This Act may be cited as the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (b) Table of contents The table of contents of this Act is as follows: Sec. 1. Short title; table of contents. TITLE I—CHEMICAL SAFETY Sec. 2. Findings, policy, and intent. Sec. 3. Definitions. Sec. 4. Testing of chemical substances and mixtures. Sec. 5. Manufacturing and processing notices. Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances and mixtures. Sec. 7. Imminent hazards. Sec. 8. Reporting and retention of information. Sec. 9. Relationship to other Federal laws. Sec. 10. Exports of elemental mercury. Sec. 11. Confidential information. Sec. 12. Penalties. Sec. 13. State-Federal relationship. Sec. 14. Judicial review. Sec. 15. Citizens’ civil actions. Sec. 16. Studies. Sec. 17. Administration of the Act. Sec. 18. State programs. Sec. 19. Conforming amendments. Sec. 20. No retroactivity. Sec. 21. Trevor’s Law. TITLE II—RURAL HEALTHCARE CONNECTIVITY Sec. 201. Short title. Sec. 202. Telecommunications services for skilled nursing facilities. I Chemical Safety 2. Findings, policy, and intent Section 2(c) of the Toxic Substances Control Act ( 15 U.S.C. 2601(c) ) is amended by striking proposes to take and inserting proposes as provided . 3. Definitions Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) by redesignating paragraphs (4) through (14) as paragraphs (5), (6), (8), (9), (10), (11), (13), (14), (15), (16), and (17), respectively; (2) by inserting after paragraph (3) the following: (4) The term conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of. ; (3) by inserting after paragraph (6), as so redesignated, the following: (7) The term guidance means any significant written guidance of general applicability prepared by the Administrator. ; and (4) by inserting after paragraph (11), as so redesignated, the following: (12) The term potentially exposed or susceptible subpopulation means a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly. . 4. Testing of chemical substances and mixtures Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) by striking standards each place it appears and inserting protocols and methodologies ; (2) in subsection (a)— (A) by striking If the Administrator finds and inserting (1) If the Administrator finds ; (B) in paragraph (1), as so designated— (i) by striking (1)(A)(i) and inserting (A)(i)(I) ; (ii) by striking (ii) each place it appears and inserting (II) ; (iii) by striking are insufficient data and inserting is insufficient information each place it appears; (iv) by striking (iii) each place it appears and inserting (III) ; (v) by striking such data and inserting such information each place it appears; (vi) by striking (B)(i) and inserting (ii)(I) ; (vii) by striking (I) and inserting (aa) ; (viii) by striking (II) and inserting (bb) ; (ix) by striking (2) and inserting (B) ; and (x) in the matter following subparagraph (B), as so redesignated— (I) by inserting , or, in the case of a chemical substance or mixture described in subparagraph (A)(i), by rule, order, or consent agreement, after rule ; (II) by striking data each place it appears and inserting information ; and (III) by striking and which are relevant and inserting and which is relevant ; and (C) by adding at the end the following: (2) Additional testing authority In addition to the authority provided under paragraph (1), the Administrator may, by rule, order, or consent agreement— (A) require the development of new information relating to a chemical substance or mixture if the Administrator determines that the information is necessary— (i) to review a notice under section 5 or to perform a risk evaluation under section 6(b); (ii) to implement a requirement imposed in a rule, order, or consent agreement under subsection (e) or (f) of section 5 or in a rule promulgated under section 6(a); (iii) at the request of a Federal implementing authority under another Federal law, to meet the regulatory testing needs of that authority with regard to toxicity and exposure; or (iv) pursuant to section 12(a)(2); and (B) require the development of new information for the purposes of prioritizing a chemical substance under section 6(b) only if the Administrator determines that such information is necessary to establish the priority of the substance, subject to the limitations that— (i) not later than 90 days after the date of receipt of information regarding a chemical substance complying with a rule, order, or consent agreement under this subparagraph, the Administrator shall designate the chemical substance as a high-priority substance or a low-priority substance; and (ii) information required by the Administrator under this subparagraph shall not be required for the purposes of establishing or implementing a minimum information requirement of broader applicability. (3) Statement of need When requiring the development of new information relating to a chemical substance or mixture under paragraph (2), the Administrator shall identify the need for the new information, describe how information reasonably available to the Administrator was used to inform the decision to require new information, explain the basis for any decision that requires the use of vertebrate animals, and, as applicable, explain why issuance of an order is warranted instead of promulgating a rule or entering into a consent agreement. (4) Tiered testing When requiring the development of new information under this subsection, the Administrator shall employ a tiered screening and testing process, under which the results of screening-level tests or assessments of available information inform the decision as to whether 1 or more additional tests are necessary, unless information available to the Administrator justifies more advanced testing of potential health or environmental effects or potential exposure without first conducting screening-level testing. ; (3) in subsection (b)— (A) in paragraph (1)— (i) in subparagraph (B), by striking test data and inserting information ; (ii) in subparagraph (C), by striking data and inserting information ; and (iii) in the matter following subparagraph (C), by striking data and inserting information ; (B) in paragraph (2)— (i) in subparagraph (A)— (I) by striking test data and inserting information ; (II) by inserting Protocols and methodologies for the development of information may also be prescribed for the assessment of exposure or exposure potential to humans or the environment. after the first sentence; and (III) by striking hierarchical tests and inserting tiered testing ; and (ii) in subparagraph (B), by striking data and inserting information ; (C) in paragraph (3)— (i) by striking data each place it appears and inserting information ; (ii) in subparagraph (A), by inserting or (C), as applicable, after subparagraph (B) ; (iii) by striking (a)(1)(A)(ii) or (a)(1)(B)(ii) each place it appears in subparagraph (B) and inserting (a)(1)(A)(i)(II) or (a)(1)(A)(ii)(II) ; (iv) in subparagraph (B), in the matter before clause (i), by striking subsection (a) and inserting subsection (a)(1) ; and (v) by adding at the end the following: (C) A rule or order under paragraph (1) or (2) of subsection (a) may require the development of information by any person who manufactures or processes, or intends to manufacture or process, a chemical substance or mixture subject to the rule or order. ; (D) in paragraph (4)— (i) by striking of data each place it appears and inserting of information ; and (ii) by striking test data each place it appears and inserting information ; and (E) by striking paragraph (5); (4) in subsection (c)— (A) in paragraph (1), by striking data and inserting information ; (B) in paragraph (2), by striking data each place it appears and inserting information ; (C) in paragraph (3)— (i) by striking test data each place it appears and inserting information ; and (ii) by striking such data each place it appears and inserting such information ; and (D) in paragraph (4) by striking test data each place it appears and inserting information ; (5) in subsection (d)— (A) by striking test data each place it appears and inserting information ; (B) by striking such data each place it appears and inserting such information ; and (C) by striking for which data have and inserting for which information has ; (6) in subsection (e)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking promulgation of a rule and inserting development of information ; and (II) by striking data each place it appears and inserting information ; and (ii) in subparagraph (B), by striking either initiate a rulemaking proceeding under subsection (a) or if such a proceeding is not initiated within such period, publish in the Federal Register the Administrator's reason for not initiating such a proceeding and insert issue an order, enter into a consent agreement, or initiate a rulemaking proceeding under subsection (a), or, if such an order or consent agreement is not issued or such a proceeding is not initiated within such period, publish in the Federal Register the Administrator’s reason for not issuing such an order, entering into such a consent agreement, or initiating such a proceeding ; and (B) in paragraph (2)(A)— (i) by striking eight members and inserting ten members ; and (ii) by adding at the end the following: (ix) One member appointed by the Chairman of the Consumer Product Safety Commission from Commissioners or employees of the Commission. (x) One member appointed by the Commissioner of Food and Drugs from employees of the Food and Drug Administration. ; (7) in subsection (f)— (A) in paragraph (1), by striking test data and inserting information ; and (B) in the matter following paragraph (2)— (i) by striking or will present ; (ii) by striking from cancer, gene mutations, or birth defects ; (iii) by striking data or ; (iv) by striking appropriate and inserting applicable ; and (v) by inserting , made without consideration of costs or other nonrisk factors, after publish in the Federal Register a finding ; (8) in subsection (g)— (A) by amending the subsection heading to read as follows: Petition for protocols and methodologies for the development of information ; (B) by striking test data each place it appears and inserting information ; and (C) by striking submit data and inserting submit information ; and (9) by adding at the end the following: (h) Reduction of testing on vertebrates (1) In general The Administrator shall reduce and replace, to the extent practicable, scientifically justified, and consistent with the policies of this title, the use of vertebrate animals in the testing of chemical substances or mixtures under this title by— (A) prior to making a request or adopting a requirement for testing using vertebrate animals, and in accordance with subsection (a)(3), taking into consideration, as appropriate and to the extent practicable and scientifically justified, reasonably available existing information, including— (i) toxicity information; (ii) computational toxicology and bioinformatics; and (iii) high-throughput screening methods and the prediction models of those methods; and (B) encouraging and facilitating— (i) the use of scientifically valid test methods and strategies that reduce or replace the use of vertebrate animals while providing information of equivalent or better scientific quality and relevance that will support regulatory decisions under this title; (ii) the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide scientifically valid and useful information on other chemical substances in the category; and (iii) the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests, provided that such consortia make all information from such testing available to the Administrator. (2) Implementation of alternative testing methods To promote the development and timely incorporation of new scientifically valid test methods and strategies that are not based on vertebrate animals, the Administrator shall— (A) not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , develop a strategic plan to promote the development and implementation of alternative test methods and strategies to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment of chemical substances or mixtures through, for example— (i) computational toxicology and bioinformatics; (ii) high-throughput screening methods; (iii) testing of categories of chemical substances; (iv) tiered testing methods; (v) in vitro studies; (vi) systems biology; (vii) new or revised methods identified by validation bodies such as the Interagency Coordinating Committee on the Validation of Alternative Methods or the Organization for Economic Co-operation and Development; or (viii) industry consortia that develop information submitted under this title; (B) as practicable, ensure that the strategic plan developed under subparagraph (A) is reflected in the development of requirements for testing under this section; (C) include in the strategic plan developed under subparagraph (A) a list, which the Administrator shall update on a regular basis, of particular alternative test methods or strategies the Administrator has identified that do not require new vertebrate animal testing and are scientifically reliable, relevant, and capable of providing information of equivalent or better scientific reliability and quality to that which would be obtained from vertebrate animal testing; (D) provide an opportunity for public notice and comment on the contents of the plan developed under subparagraph (A), including the criteria for considering scientific reliability and relevance of the test methods and strategies that may be identified pursuant to subparagraph (C); (E) beginning on the date that is 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and every 5 years thereafter, submit to Congress a report that describes the progress made in implementing the plan developed under subparagraph (A) and goals for future alternative test methods and strategies implementation; and (F) prioritize and, to the extent consistent with available resources and the Administrator’s other responsibilities under this title, carry out performance assessment, validation, and translational studies to accelerate the development of scientifically valid test methods and strategies that reduce, refine, or replace the use of vertebrate animals, including minimizing duplication, in any testing under this title. (3) Voluntary testing (A) In general Any person developing information for submission under this title on a voluntary basis and not pursuant to any request or requirement by the Administrator shall first attempt to develop the information by means of an alternative test method or strategy identified by the Administrator pursuant to paragraph (2)(C), if the Administrator has identified such a test method or strategy for the development of such information, before conducting new vertebrate animal testing. (B) Effect of paragraph Nothing in this paragraph shall, under any circumstance, limit or restrict the submission of any existing information to the Administrator. (C) Relationship to other law A violation of this paragraph shall not be a prohibited act under section 15. (D) Review of means This paragraph authorizes, but does not require, the Administrator to review the means by which a person conducted testing described in subparagraph (A). . 5. Manufacturing and processing notices Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) by striking Except as provided in and inserting (A) Except as provided in subparagraph (B) of this paragraph and ; (ii) by redesignating subparagraphs (A) and (B) as clauses (i) and (ii), respectively; (iii) by striking all that follows significant new use and inserting a period; and (iv) by adding at the end the following: (B) A person may take the actions described in subparagraph (A) if— (i) such person submits to the Administrator, at least 90 days before such manufacture or processing, a notice, in accordance with subsection (d), of such person’s intention to manufacture or process such substance and such person complies with any applicable requirement of, or imposed pursuant to, subsection (b), (e), or (f); and (ii) the Administrator— (I) conducts a review of the notice; and (II) makes a determination under subparagraph (A), (B), or (C) of paragraph (3) and takes the actions required in association with that determination under such subparagraph within the applicable review period. ; and (B) by adding at the end the following new paragraphs: (3) Review and determination Within the applicable review period, subject to section 18, the Administrator shall review such notice and determine— (A) that the relevant chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, in which case the Administrator shall take the actions required under subsection (f); (B) that— (i) the information available to the Administrator is insufficient to permit a reasoned evaluation of the health and environmental effects of the relevant chemical substance or significant new use; or (ii) (I) in the absence of sufficient information to permit the Administrator to make such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator; or (II) such substance is or will be produced in substantial quantities, and such substance either enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance, in which case the Administrator shall take the actions required under subsection (e); or (C) that the relevant chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, in which case the submitter of the notice may commence manufacture of the chemical substance or manufacture or processing for a significant new use. (4) Failure to render determination (A) Failure to render determination If the Administrator fails to make a determination on a notice under paragraph (3) by the end of the applicable review period and the notice has not been withdrawn by the submitter, the Administrator shall refund to the submitter all applicable fees charged to the submitter for review of the notice pursuant to section 26(b), and the Administrator shall not be relieved of any requirement to make such determination. (B) Limitations (i) A refund of applicable fees under subparagraph (A) shall not be made if the Administrator certifies that the submitter has not provided information required under subsection (b) or has otherwise unduly delayed the process such that the Administrator is unable to render a determination within the applicable review period. (ii) A failure of the Administrator to render a decision shall not be deemed to constitute a withdrawal of the notice. (iii) Nothing in this paragraph shall be construed as relieving the Administrator or the submitter of the notice from any requirement of this section. (5) Article consideration The Administrator may require notification under this section for the import or processing of a chemical substance as part of an article or category of articles under paragraph (1)(A)(ii) if the Administrator makes an affirmative finding in a rule under paragraph (2) that the reasonable potential for exposure to the chemical substance through the article or category of articles subject to the rule justifies notification. ; (2) in subsection (b)— (A) in the subsection heading, by striking Test Data and inserting Information ; (B) in paragraph (1)— (i) in subparagraph (A)— (I) by striking test data and inserting information ; and (II) by striking such data and inserting such information ; and (ii) in subparagraph (B)— (I) by striking test data and inserting information ; (II) by striking subsection (a)(1)(A) and inserting subsection (a)(1)(A)(i) ; and (III) by striking subsection (a)(1)(B) and inserting subsection (a)(1)(A)(ii) ; (C) in paragraph (2)— (i) in subparagraph (A)— (I) by striking test data in clause (ii) and inserting information ; (II) by striking shall and inserting may ; and (III) by striking data prescribed and inserting information prescribed ; and (ii) in subparagraph (B)— (I) by striking Data and inserting Information ; (II) by striking data both places it appears and inserting information ; (III) by striking show and inserting shows ; (IV) by striking subsection (a)(1)(A) in clause (i) and inserting subsection (a)(1)(A)(i) ; and (V) by striking subsection (a)(1)(B) in clause (ii) and inserting subsection (a)(1)(A)(ii) ; (D) in paragraph (3)— (i) by striking Data and inserting Information ; and (ii) by striking paragraph (1) or (2) and inserting paragraph (1) or (2) of this subsection or under subsection (e) ; and (E) in paragraph (4)— (i) in subparagraph (A)(i), by inserting , without consideration of costs or other nonrisk factors after health or the environment ; and (ii) in subparagraph (C), by striking , except that and all that follows through subparagraph (A) ; (3) in subsection (c)— (A) in the subsection heading, by striking Notice and inserting Review ; and (B) by striking before which and all that follows through subsection may begin ; (4) in subsection (d)— (A) by striking test data in paragraph (1)(B) and inserting information ; (B) by striking data each place it appears in paragraph (1)(C) and paragraph (2) and inserting information ; (C) in paragraph (2)(B), by striking uses or intended uses of such substance and inserting uses of such substance identified in the notice ; and (D) in paragraph (3)— (i) by striking for which the notification period prescribed by subsection (a), (b), or (c) and inserting for which the applicable review period ; and (ii) by striking such notification period and inserting such period ; (5) in subsection (e)— (A) in paragraph (1)(A)— (i) in clause (i), by striking ; and and inserting ; or ; (ii) in clause (ii)(I), by inserting without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed subpopulation identified as relevant by the Administrator under the conditions of use; after health or the environment, ; and (iii) in the matter after clause (ii)(II)— (I) by striking may issue a proposed order and inserting shall issue an order ; (II) by striking notification period applicable to the manufacturing or processing of such substance under subsection (a), (b), (c) and inserting applicable review period ; and (III) by inserting to the extent necessary to protect against an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, and the submitter of the notice may commence manufacture of the chemical substance, or manufacture or processing of the chemical substance for a significant new use, including while any required information is being developed, only in compliance with the order before the period at the end; (B) in paragraph (1)(B)— (i) by striking A proposed order and inserting An order ; (ii) by striking notification period applicable to the manufacture or processing of such substance under subsection (a), (b), (c) and inserting applicable review period ; and (iii) by striking of the proposed order and inserting of the order ; (C) by striking paragraph (1)(C); and (D) by striking paragraph (2); (6) in subsection (f)— (A) in paragraph (1)— (i) by striking finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance with and inserting determines that a chemical substance or significant new use with ; (ii) by striking , or that any combination of such activities, ; (iii) by striking or will present ; (iv) by striking before a rule promulgated under section 6 can protect against such risk, and inserting , without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed subpopulation identified as relevant by the Administrator under the conditions of use, ; and (v) by striking notification period applicable under subsection (a), (b), or (c) to the manufacturing or processing of such substance and inserting applicable review period ; (B) in paragraph (2), the matter following subparagraph (C), by striking Section 6(d)(2)(B) and inserting Section 6(d)(3)(B) ; (C) in paragraph (3)— (i) in subparagraph (A)— (I) by striking Administrator may and all that follows through issue a proposed order to prohibit the and inserting Administrator may issue an order to prohibit or limit the ; and (II) by striking under paragraph (1) and all that follows through processing of such substance. and inserting under paragraph (1). Such order shall take effect on the expiration of the applicable review period. ; (ii) by striking subparagraph (B) and redesignating subparagraph (C) as subparagraph (B); (iii) in subparagraph (B), as so redesignated— (I) by striking subparagraphs (B) and (C) and inserting subparagraph (B) ; (II) by striking clause (i) of ; and (III) by striking ; and the provisions of subparagraph (C) of subsection (e)(2) shall apply with respect to an injunction issued under subparagraph (B) ; and (iv) by striking subparagraph (D); and (D) by adding at the end the following: (4) Treatment of nonconforming uses Not later than 90 days after taking an action under paragraph (2) or (3) or issuing an order under subsection (e) relating to a chemical substance with respect to which the Administrator has made a determination under subsection (a)(3)(A) or (B), the Administrator shall consider whether to promulgate a rule pursuant to subsection (a)(2) that identifies as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance that does not conform to the restrictions imposed by the action or order, and, as applicable, initiate such a rulemaking or publish a statement describing the reasons of the Administrator for not initiating such a rulemaking. (5) Workplace exposures To the extent practicable, the Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health prior to adopting any prohibition or other restriction relating to a chemical substance with respect to which the Administrator has made a determination under subsection (a)(3)(A) or (B) to address workplace exposures. ; (7) by amending subsection (g) to read as follows: (g) Statement on administrator finding If the Administrator finds in accordance with subsection (a)(3)(C) that a chemical substance or significant new use is not likely to present an unreasonable risk of injury to health or the environment, then notwithstanding any remaining portion of the applicable review period, the submitter of the notice may commence manufacture of the chemical substance or manufacture or processing for the significant new use, and the Administrator shall make public a statement of the Administrator’s finding. Such a statement shall be submitted for publication in the Federal Register as soon as is practicable before the expiration of such period. Publication of such statement in accordance with the preceding sentence is not a prerequisite to the manufacturing or processing of the substance with respect to which the statement is to be published. ; (8) in subsection (h)— (A) in paragraph (1)(A), by inserting , including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by the Administrator for the specific conditions of use identified in the application after health or the environment ; (B) in paragraph (2), by striking data each place it appears and inserting information ; and (C) in paragraph (4), by striking . A rule promulgated and all that follows through section 6(c) and inserting , including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by the Administrator under the conditions of use ; and (9) by amending subsection (i) to read as follows: (i) Definitions (1) For purposes of this section, the terms manufacture and process mean manufacturing or processing for commercial purposes. (2) For purposes of this Act, the term requirement as used in this section shall not displace any statutory or common law. (3) For purposes of this section, the term applicable review period means the period starting on the date the Administrator receives a notice under subsection (a)(1) and ending 90 days after that date, or on such date as is provided for in subsection (b)(1) or (c). . 6. Prioritization, risk evaluation, and regulation of chemical substances and mixtures Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— (1) by striking the section heading and inserting Prioritization, risk evaluation, and regulation of chemical substances and mixtures ; (2) in subsection (a)— (A) by striking finds that there is a reasonable basis to conclude and inserting determines in accordance with subsection (b)(4)(A) ; (B) by striking or will present ; (C) by inserting and subject to section 18, and in accordance with subsection (c)(2), after shall by rule ; (D) by striking to protect adequately against such risk using the least burdensome requirements and inserting so that the chemical substance or mixture no longer presents such risk ; (E) by inserting or otherwise restricting after prohibiting in paragraphs (1)(A) and (2)(A); (F) by inserting minimum before warnings both places it appears in paragraph (3); (G) by striking and monitor or conduct tests and inserting or monitor or conduct tests in paragraph (4); and (H) in paragraph (7)— (i) by striking such unreasonable risk of injury and inserting such determination ; and (ii) by striking such risk of injury and inserting such determination ; (3) by amending subsection (b) to read as follows: (b) Risk evaluations (1) Prioritization for risk evaluations (A) Establishment of process Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall establish, by rule, a risk-based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time. The process to designate the priority of chemical substances shall include a consideration of the hazard and exposure potential of a chemical substance or a category of chemical substances (including consideration of persistence and bioaccumulation, potentially exposed or susceptible subpopulations and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed. (B) Identification of priorities for risk evaluation (i) High-priority substances The Administrator shall designate as a high-priority substance a chemical substance that the Administrator concludes, without consideration of costs or other nonrisk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator. (ii) Low-priority substances The Administrator shall designate a chemical substance as a low-priority substance if the Administrator concludes, based on information sufficient to establish, without consideration of costs or other nonrisk factors, that such substance does not meet the standard identified in clause (i) for designating a chemical substance a high-priority substance. (C) Information request and review and proposed and final prioritization designation The rulemaking required in subparagraph (A) shall ensure that the time required to make a priority designation of a chemical substance be no shorter than nine months and no longer than 1 year, and that the process for such designations includes— (i) a requirement that the Administrator request interested persons to submit relevant information on a chemical substance that the Administrator has initiated the prioritization process on, before proposing a priority designation for the chemical substance, and provide 90 days for such information to be provided; (ii) a requirement that the Administrator publish each proposed designation of a chemical substance as a high- or low-priority substance, along with an identification of the information, analysis, and basis used to make the proposed designations, and provide 90 days for public comment on each such proposed designation; and (iii) a process by which the Administrator may extend the deadline in clause (i) for up to three months in order to receive or evaluate information required to be submitted in accordance with section 4(a)(2)(B), subject to the limitation that if the information available to the Administrator at the end of such an extension remains insufficient to enable the designation of the chemical substance as a low-priority substance, the Administrator shall designate the chemical substance as a high-priority substance. (2) Initial risk evaluations and subsequent designations of high- and low-priority substances (A) Initial risk evaluations Not later than 180 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall ensure that risk evaluations are being conducted on 10 chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments and shall publish the list of such chemical substances during the 180 day period. (B) Additional risk evaluations Not later than three and one half years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall ensure that risk evaluations are being conducted on at least 20 high-priority substances and that at least 20 chemical substances have been designated as low-priority substances, subject to the limitation that at least 50 percent of all chemical substances on which risk evaluations are being conducted by the Administrator are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments. (C) Continuing designations and risk evaluations The Administrator shall continue to designate priority substances and conduct risk evaluations in accordance with this subsection at a pace consistent with the ability of the Administrator to complete risk evaluations in accordance with the deadlines under paragraph (4)(G). (D) Preference In designating high-priority substances, the Administrator shall give preference to— (i) chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments as having a Persistence and Bioaccumulation Score of 3; and (ii) chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments that are known human carcinogens and have high acute and chronic toxicity. (E) Metals and metal compounds In identifying priorities for risk evaluation and conducting risk evaluations of metals and metal compounds, the Administrator shall use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated March 2007, or a successor document that addresses metals risk assessment and is peer reviewed by the Science Advisory Board. (3) Initiation of risk evaluations; designations (A) Risk evaluation initiation Upon designating a chemical substance as a high-priority substance, the Administrator shall initiate a risk evaluation on the substance. (B) Revision The Administrator may revise the designation of a low-priority substance based on information made available to the Administrator. (C) Ongoing designations The Administrator shall designate at least one high-priority substance upon the completion of each risk evaluation (other than risk evaluations for chemical substances designated under paragraph (4)(C)(ii)). (4) Risk evaluation process and deadlines (A) In general The Administrator shall conduct risk evaluations pursuant to this paragraph to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use. (B) Establishment of process Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A). (C) Requirement The Administrator shall conduct and publish risk evaluations, in accordance with the rule promulgated under subparagraph (B), for a chemical substance— (i) that has been identified under paragraph (2)(A) or designated under paragraph (1)(B)(i); and (ii) subject to subparagraph (E), that a manufacturer of the chemical substance has requested, in a form and manner and using the criteria prescribed by the Administrator in the rule promulgated under subparagraph (B), be subjected to a risk evaluation. (D) Scope The Administrator shall, not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider, and, for each designation of a high-priority substance, ensure not less than 12 months between the initiation of the prioritization process for the chemical substance and the publication of the scope of the risk evaluation for the chemical substance, and for risk evaluations conducted on chemical substances that have been identified under paragraph (2)(A) or selected under subparagraph (E)(iv)(II) of this paragraph, ensure not less than 3 months before the Administrator publishes the scope of the risk evaluation. (E) Limitation and criteria (i) Percentage requirements The Administrator shall ensure that, of the number of chemical substances that undergo a risk evaluation under clause (i) of subparagraph (C), the number of chemical substances undergoing a risk evaluation under clause (ii) of subparagraph (C) is— (I) not less than 25 percent, if sufficient requests are made under clause (ii) of subparagraph (C); and (II) not more than 50 percent. (ii) Requested risk evaluations Requests for risk evaluations under subparagraph (C)(ii) shall be subject to the payment of fees pursuant to section 26(b), and the Administrator shall not expedite or otherwise provide special treatment to such risk evaluations. (iii) Preference In deciding whether to grant requests under subparagraph (C)(ii), the Administrator shall give preference to requests for risk evaluations on chemical substances for which the Administrator determines that restrictions imposed by 1 or more States have the potential to have a significant impact on interstate commerce or health or the environment. (iv) Exceptions (I) Chemical substances for which requests have been granted under subparagraph (C)(ii) shall not be subject to section 18(b). (II) Requests for risk evaluations on chemical substances which are made under subparagraph (C)(ii) and that are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments shall be granted at the discretion of the Administrator and not be subject to clause (i)(II). (F) Requirements In conducting a risk evaluation under this subsection, the Administrator shall— (i) integrate and assess available information on hazards and exposures for the conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed or susceptible subpopulations identified as relevant by the Administrator; (ii) describe whether aggregate or sentinel exposures to a chemical substance under the conditions of use were considered, and the basis for that consideration; (iii) not consider costs or other nonrisk factors; (iv) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use of the chemical substance; and (v) describe the weight of the scientific evidence for the identified hazard and exposure. (G) Deadlines The Administrator— (i) shall complete a risk evaluation for a chemical substance as soon as practicable, but not later than 3 years after the date on which the Administrator initiates the risk evaluation under subparagraph (C); and (ii) may extend the deadline for a risk evaluation for not more than 6 months. (H) Notice and comment The Administrator shall provide no less than 30 days public notice and an opportunity for comment on a draft risk evaluation prior to publishing a final risk evaluation. ; (4) by amending subsection (c) to read as follows: (c) Promulgation of subsection (a) rules (1) Deadlines If the Administrator determines that a chemical substance presents an unreasonable risk of injury to health or the environment in accordance with subsection (b)(4)(A), the Administrator— (A) shall propose in the Federal Register a rule under subsection (a) for the chemical substance not later than 1 year after the date on which the final risk evaluation regarding the chemical substance is published; (B) shall publish in the Federal Register a final rule not later than 2 years after the date on which the final risk evaluation regarding the chemical substance is published; and (C) may extend the deadlines under this paragraph for not more than 2 years, subject to the condition that the aggregate length of extensions under this subparagraph and subsection (b)(4)(G)(ii) does not exceed 2 years, and subject to the limitation that the Administrator may not extend a deadline for the publication of a proposed or final rule regarding a chemical substance drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments or a chemical substance that, with respect to persistence and bioaccumulation, scores high for 1 and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012 (or a successor scoring system), without adequate public justification that demonstrates, following a review of the information reasonably available to the Administrator, that the Administrator cannot complete the proposed or final rule without additional information regarding the chemical substance. (2) Requirements for rule (A) Statement of effects In proposing and promulgating a rule under subsection (a) with respect to a chemical substance or mixture, the Administrator shall consider and publish a statement based on reasonably available information with respect to— (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture; (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture; (iii) the benefits of the chemical substance or mixture for various uses; and (iv) the reasonably ascertainable economic consequences of the rule, including consideration of— (I) the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; (II) the costs and benefits of the proposed and final regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator; and (III) the cost effectiveness of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator. (B) Selecting requirements In selecting among prohibitions and other restrictions, the Administrator shall factor in, to the extent practicable, the considerations under subparagraph (A) in accordance with subsection (a). (C) Consideration of alternatives Based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, the Administrator shall consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect. (D) Replacement parts (i) In general The Administrator shall exempt replacement parts for complex durable goods and complex consumer goods that are designed prior to the date of publication in the Federal Register of the rule under subsection (a), unless the Administrator finds that such replacement parts contribute significantly to the risk, identified in a risk evaluation conducted under subsection (b)(4)(A), to the general population or to an identified potentially exposed or susceptible subpopulation. (ii) Definitions In this subparagraph— (I) the term complex consumer goods means electronic or mechanical devices composed of multiple manufactured components, with an intended useful life of 3 or more years, where the product is typically not consumed, destroyed, or discarded after a single use, and the components of which would be impracticable to redesign or replace; and (II) the term complex durable goods means manufactured goods composed of 100 or more manufactured components, with an intended useful life of 5 or more years, where the product is typically not consumed, destroyed, or discarded after a single use. (E) Articles In selecting among prohibitions and other restrictions, the Administrator shall apply such prohibitions or other restrictions to an article or category of articles containing the chemical substance or mixture only to the extent necessary to address the identified risks from exposure to the chemical substance or mixture from the article or category of articles so that the substance or mixture does not present an unreasonable risk of injury to health or the environment identified in the risk evaluation conducted in accordance with subsection (b)(4)(A). (3) Procedures When prescribing a rule under subsection (a) the Administrator shall proceed in accordance with section 553 of title 5, United States Code (without regard to any reference in such section to sections 556 and 557 of such title), and shall also— (A) publish a notice of proposed rulemaking stating with particularity the reason for the proposed rule; (B) allow interested persons to submit written data, views, and arguments, and make all such submissions publicly available; (C) promulgate a final rule based on the matter in the rulemaking record; and (D) make and publish with the rule the determination described in subsection (a). ; (5) in subsection (d)— (A) by redesignating paragraph (2) as paragraph (3); (B) by striking paragraph (1) and inserting the following: (1) In general In any rule under subsection (a), the Administrator shall— (A) specify the date on which it shall take effect, which date shall be as soon as practicable; (B) except as provided in subparagraphs (C) and (D), specify mandatory compliance dates for all of the requirements under a rule under subsection (a), which shall be as soon as practicable, but not later than 5 years after the date of promulgation of the rule, except in a case of a use exempted under subsection (g); (C) specify mandatory compliance dates for the start of ban or phase-out requirements under a rule under subsection (a), which shall be as soon as practicable, but not later than 5 years after the date of promulgation of the rule, except in the case of a use exempted under subsection (g); (D) specify mandatory compliance dates for full implementation of ban or phase-out requirements under a rule under subsection (a), which shall be as soon as practicable; and (E) provide for a reasonable transition period. (2) Variability As determined by the Administrator, the compliance dates established under paragraph (1) may vary for different affected persons. ; and (C) in paragraph (3), as so redesignated by subparagraph (A) of this paragraph— (i) in subparagraph (A)— (I) by striking upon its publication and all that follows through respecting such rule if and inserting , and compliance with the proposed requirements to be mandatory, upon publication in the Federal Register of the proposed rule and until the compliance dates applicable to such requirements in a final rule promulgated under section 6(a) or until the Administrator revokes such proposed rule, in accordance with subparagraph (B), if ; and (II) in clause (i)(I), by inserting without consideration of costs or other non-risk factors after effective date ; and (ii) in subparagraph (B), by striking , provide reasonable opportunity and all that follows through the period at the end and inserting in accordance with subsection (c), and either promulgate such rule (as proposed or with modifications) or revoke it. ; (6) in subsection (e)(4), by striking paragraphs (2), (3), and (4) and inserting paragraph (3) ; and (7) by adding at the end the following new subsections: (g) Exemptions (1) Criteria for exemption The Administrator may, as part of a rule promulgated under subsection (a), or in a separate rule, grant an exemption from a requirement of a subsection (a) rule for a specific condition of use of a chemical substance or mixture, if the Administrator finds that— (A) the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; (B) compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or (C) the specific condition of use of the chemical substance or mixture, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. (2) Exemption analysis and statement In proposing an exemption under this subsection, the Administrator shall analyze the need for the exemption, and shall make public the analysis and a statement describing how the analysis was taken into account. (3) Period of exemption The Administrator shall establish, as part of a rule under this subsection, a time limit on any exemption for a time to be determined by the Administrator as reasonable on a case-by-case basis, and, by rule, may extend, modify, or eliminate an exemption if the Administrator determines, on the basis of reasonably available information and after adequate public justification, the exemption warrants extension or modification or is no longer necessary. (4) Conditions As part of a rule promulgated under this subsection, the Administrator shall include conditions, including reasonable recordkeeping, monitoring, and reporting requirements, to the extent that the Administrator determines the conditions are necessary to protect health and the environment while achieving the purposes of the exemption. (h) Chemicals that are persistent, bioaccumulative, and toxic (1) Expedited action Not later than 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall propose rules under subsection (a) with respect to chemical substances identified in the 2014 update of the TSCA Work Plan for Chemical Assessments— (A) that the Administrator has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012 (or a successor scoring system), and are not a metal or a metal compound, and for which the Administrator has not completed a Work Plan Problem Formulation, initiated a review under section 5, or entered into a consent agreement under section 4, prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; and (B) exposure to which under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator, or the environment, on the basis of an exposure and use assessment conducted by the Administrator. (2) No risk evaluation required The Administrator shall not be required to conduct risk evaluations on chemical substances that are subject to paragraph (1). (3) Final rule Not later than 18 months after proposing a rule pursuant to paragraph (1), the Administrator shall promulgate a final rule under subsection (a). (4) Selecting restrictions In selecting among prohibitions and other restrictions promulgated in a rule under subsection (a) pursuant to paragraph (1), the Administrator shall address the risks of injury to health or the environment that the Administrator determines are presented by the chemical substance and shall reduce exposure to the substance to the extent practicable. (5) Relationship to subsection (b) If, at any time prior to the date that is 90 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator makes a designation under subsection (b)(1)(B)(i), or receives a request under subsection (b)(4)(C)(ii), such chemical substance shall not be subject to this subsection, except that in selecting among prohibitions and other restrictions promulgated in a rule pursuant to subsection (a), the Administrator shall both ensure that the chemical substance meets the rulemaking standard under subsection (a) and reduce exposure to the substance to the extent practicable. (i) Final agency action Under this section and subject to section 18— (1) a determination by the Administrator under subsection (b)(4)(A) that a chemical substance does not present an unreasonable risk of injury to health or the environment shall be issued by order and considered to be a final agency action, effective beginning on the date of issuance of the order; and (2) a final rule promulgated under subsection (a), including the associated determination by the Administrator under subsection (b)(4)(A) that a chemical substance presents an unreasonable risk of injury to health or the environment, shall be considered to be a final agency action, effective beginning on the date of promulgation of the final rule. (j) Definition For the purposes of this Act, the term requirement as used in this section shall not displace statutory or common law. . 7. Imminent hazards Section 7 of the Toxic Substances Control Act ( 15 U.S.C. 2606 ) is amended— (1) in subsection (b)(1), by inserting (as identified by the Administrator without consideration of costs or other nonrisk factors) after from the unreasonable risk ; and (2) in subsection (f), by inserting , without consideration of costs or other nonrisk factors after widespread injury to health or the environment . 8. Reporting and retention of information (a) In general Section 8 of the Toxic Substances Control Act ( 15 U.S.C. 2607 ) is amended— (1) in subsection (a)— (A) in paragraph (2), by striking the matter that follows subparagraph (G); (B) in paragraph (3), by adding at the end the following: (C) Not later than 180 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and not less frequently than once every 10 years thereafter, the Administrator, after consultation with the Administrator of the Small Business Administration, shall— (i) review the adequacy of the standards prescribed under subparagraph (B); and (ii) after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted. ; and (C) by adding at the end the following: (4) Contents The rules promulgated pursuant to paragraph (1)— (A) may impose differing reporting and recordkeeping requirements on manufacturers and processors; and (B) shall include the level of detail necessary to be reported, including the manner by which use and exposure information may be reported. (5) Administration In carrying out this section, the Administrator shall, to the extent feasible— (A) not require reporting which is unnecessary or duplicative; (B) minimize the cost of compliance with this section and the rules issued thereunder on small manufacturers and processors; and (C) apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this title. (6) Negotiated rulemaking (A) The Administrator shall enter into a negotiated rulemaking pursuant to subchapter III of chapter 5 of title 5, United States Code, to develop and publish, not later than 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , a proposed rule providing for limiting the reporting requirements, under this subsection, for manufacturers of any inorganic byproducts, when such byproducts, whether by the byproduct manufacturer or by any other person, are subsequently recycled, reused, or reprocessed. (B) Not later than 3 and one-half years after such date of enactment, the Administrator shall publish a final rule resulting from such negotiated rulemaking. ; and (2) in subsection (b), by adding at the end the following: (3) Nomenclature (A) In general In carrying out paragraph (1), the Administrator shall— (i) maintain the use of Class 2 nomenclature in use on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; (ii) maintain the use of the Soap and Detergent Association Nomenclature System, published in March 1978 by the Administrator in section 1 of addendum III of the document entitled Candidate List of Chemical Substances , and further described in the appendix A of volume I of the 1985 edition of the Toxic Substances Control Act Substances Inventory (EPA Document No. EPA–560/7–85–002a); and (iii) treat the individual members of the categories of chemical substances identified by the Administrator as statutory mixtures, as defined in Inventory descriptions established by the Administrator, as being included on the list established under paragraph (1). (B) Multiple nomenclature listings If a manufacturer or processor demonstrates to the Administrator that a chemical substance appears multiple times on the list published under paragraph (1) under different CAS numbers, the Administrator may recognize the multiple listings as a single chemical substance. (4) Chemical substances in commerce (A) Rules (i) In general Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator, by rule, shall require manufacturers, and may require processors, subject to the limitations under subsection (a)(5)(A), to notify the Administrator, by not later than 180 days after the date on which the final rule is published in the Federal Register, of each chemical substance on the list published under paragraph (1) that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (ii) Active substances The Administrator shall designate chemical substances for which notices are received under clause (i) to be active substances on the list published under paragraph (1). (iii) Inactive substances The Administrator shall designate chemical substances for which no notices are received under clause (i) to be inactive substances on the list published under paragraph (1). (iv) Limitation No chemical substance on the list published under paragraph (1) shall be removed from such list by reason of the implementation of this subparagraph, or be subject to section 5(a)(1)(A)(i) by reason of a change to active status under paragraph (5)(B). (B) Confidential chemical substances In promulgating a rule under subparagraph (A), the Administrator shall— (i) maintain the list under paragraph (1), which shall include a confidential portion and a nonconfidential portion consistent with this section and section 14; (ii) require any manufacturer or processor of a chemical substance on the confidential portion of the list published under paragraph (1) that seeks to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential pursuant to section 14 to submit a notice under subparagraph (A) that includes such request; (iii) require the substantiation of those claims pursuant to section 14 and in accordance with the review plan described in subparagraph (C); and (iv) move any active chemical substance for which no request was received to maintain an existing claim for protection against disclosure of the specific chemical identity of the chemical substance as confidential from the confidential portion of the list published under paragraph (1) to the nonconfidential portion of that list. (C) Review plan Not later than 1 year after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A), the Administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific chemical identities of chemical substances on the confidential portion of the list published under paragraph (1) that are asserted pursuant to subparagraph (B). (D) Requirements of review plan In establishing the review plan under subparagraph (C), the Administrator shall— (i) require, at a time specified by the Administrator, all manufacturers or processors asserting claims under subparagraph (B) to substantiate the claim, in accordance with section 14, unless the manufacturer or processor has substantiated the claim in a submission made to the Administrator during the 5-year period ending on the last day of the of the time period specified by the Administrator; and (ii) in accordance with section 14— (I) review each substantiation— (aa) submitted pursuant to clause (i) to determine if the claim qualifies for protection from disclosure; and (bb) submitted previously by a manufacturer or processor and relied on in lieu of the substantiation required pursuant to clause (i), if the substantiation has not been previously reviewed by the Administrator, to determine if the claim warrants protection from disclosure; (II) approve, approve in part and deny in part, or deny each claim; and (III) except as provided in this section and section 14, protect from disclosure information for which the Administrator approves such a claim for a period of 10 years, unless, prior to the expiration of the period— (aa) the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall not protect the information from disclosure; or (bb) the Administrator otherwise becomes aware that the information does not qualify for protection from disclosure, in which case the Administrator shall take the actions described in section 14(g)(2). (E) Timeline for completion of reviews (i) In general The Administrator shall implement the review plan so as to complete reviews of all claims specified in subparagraph (C) not later than 5 years after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A). (ii) Considerations (I) In general The Administrator may extend the deadline for completion of the reviews for not more than 2 additional years, after an adequate public justification, if the Administrator determines that the extension is necessary based on the number of claims needing review and the available resources. (II) Annual review goal and results At the beginning of each year, the Administrator shall publish an annual goal for reviews and the number of reviews completed in the prior year. (5) Active and inactive substances (A) In general The Administrator shall keep designations of active substances and inactive substances on the list published under paragraph (1) current. (B) Change to active status (i) In general Any person that intends to manufacture or process for a nonexempt commercial purpose a chemical substance that is designated as an inactive substance shall notify the Administrator before the date on which the inactive substance is manufactured or processed. (ii) Confidential chemical identity If a person submitting a notice under clause (i) for an inactive substance on the confidential portion of the list published under paragraph (1) seeks to maintain an existing claim for protection against disclosure of the specific chemical identity of the inactive substance as confidential, the person shall, consistent with the requirements of section 14— (I) in the notice submitted under clause (i), assert the claim; and (II) by not later than 30 days after providing the notice under clause (i), substantiate the claim. (iii) Active status On receiving a notification under clause (i), the Administrator shall— (I) designate the applicable chemical substance as an active substance; (II) pursuant to section 14, promptly review any claim and associated substantiation submitted pursuant to clause (ii) for protection against disclosure of the specific chemical identity of the chemical substance and approve, approve in part and deny in part, or deny the claim; (III) except as provided in this section and section 14, protect from disclosure the specific chemical identity of the chemical substance for which the Administrator approves a claim under subclause (II) for a period of 10 years, unless, prior to the expiration of the period— (aa) the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall not protect the information from disclosure; or (bb) the Administrator otherwise becomes aware that the information does not qualify for protection from disclosure, in which case the Administrator shall take the actions described in section 14(g)(2); and (IV) pursuant to section 6(b), review the priority of the chemical substance as the Administrator determines to be necessary. (C) Category status The list of inactive substances shall not be considered to be a category for purposes of section 26(c). (6) Interim list of active substances Prior to the promulgation of the rule required under paragraph (4)(A), the Administrator shall designate the chemical substances reported under part 711 of title 40, Code of Federal Regulations (as in effect on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ), during the reporting period that most closely preceded the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , as the interim list of active substances for the purposes of section 6(b). (7) Public information Subject to this subsection and section 14, the Administrator shall make available to the public— (A) each specific chemical identity on the nonconfidential portion of the list published under paragraph (1) along with the Administrator’s designation of the chemical substance as an active or inactive substance; (B) the unique identifier assigned under section 14, accession number, generic name, and, if applicable, premanufacture notice case number for each chemical substance on the confidential portion of the list published under paragraph (1) for which a claim of confidentiality was received; and (C) the specific chemical identity of any active substance for which— (i) a claim for protection against disclosure of the specific chemical identity of the active substance was not asserted, as required under this subsection or section 14; (ii) all claims for protection against disclosure of the specific chemical identity of the active substance have been denied by the Administrator; or (iii) the time period for protection against disclosure of the specific chemical identity of the active substance has expired. (8) Limitation No person may assert a new claim under this subsection or section 14 for protection from disclosure of a specific chemical identity of any active or inactive substance for which a notice is received under paragraph (4)(A)(i) or (5)(B)(i) that is not on the confidential portion of the list published under paragraph (1). (9) Certification Under the rules promulgated under this subsection, manufacturers and processors, as applicable, shall be required— (A) to certify that each notice or substantiation the manufacturer or processor submits complies with the requirements of the rule, and that any confidentiality claims are true and correct; and (B) to retain a record documenting compliance with the rule and supporting confidentiality claims for a period of 5 years beginning on the last day of the submission period. . (b) Mercury inventory Section 8(b) of the Toxic Substances Control Act ( 15 U.S.C. 2607(b) ) (as amended by subsection (a)) is further amended by adding at the end the following: (10) Mercury (A) Definition of mercury In this paragraph, notwithstanding section 3(2)(B), the term mercury means— (i) elemental mercury; and (ii) a mercury compound. (B) Publication Not later than April 1, 2017, and every 3 years thereafter, the Administrator shall carry out and publish in the Federal Register an inventory of mercury supply, use, and trade in the United States. (C) Process In carrying out the inventory under subparagraph (B), the Administrator shall— (i) identify any manufacturing processes or products that intentionally add mercury; and (ii) recommend actions, including proposed revisions of Federal law or regulations, to achieve further reductions in mercury use. (D) Reporting (i) In general To assist in the preparation of the inventory under subparagraph (B), any person who manufactures mercury or mercury-added products or otherwise intentionally uses mercury in a manufacturing process shall make periodic reports to the Administrator, at such time and including such information as the Administrator shall determine by rule promulgated not later than 2 years after the date of enactment of this paragraph. (ii) Coordination To avoid duplication, the Administrator shall coordinate the reporting under this subparagraph with the Interstate Mercury Education and Reduction Clearinghouse. (iii) Exemption Clause (i) shall not apply to a person engaged in the generation, handling, or management of mercury-containing waste, unless that person manufactures or recovers mercury in the management of that waste. . 9. Relationship to other Federal laws Section 9 of the Toxic Substances Control Act ( 15 U.S.C. 2608 ) is amended— (1) in subsection (a)— (A) in paragraph (1)— (i) by striking has reasonable basis to conclude and inserting determines ; (ii) by striking or will present ; and (iii) by inserting , without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator, under the conditions of use, after or the environment ; (B) in paragraph (2)— (i) in subparagraph (A), by inserting , within the time period specified by the Administrator in the report, after issues an order ; and (ii) in subparagraph (B), by inserting responds within the time period specified by the Administrator in the report and before initiates, within 90 ; (C) by redesignating paragraph (3) as paragraph (6); and (D) by inserting after paragraph (2) the following: (3) The Administrator shall take the actions described in paragraph (4) if the Administrator makes a report under paragraph (1) with respect to a chemical substance or mixture and the agency to which the report was made does not— (A) issue the order described in paragraph (2)(A) within the time period specified by the Administrator in the report; or (B) (i) respond under paragraph (1) within the timeframe specified by the Administrator in the report; and (ii) initiate action within 90 days of publication in the Federal Register of the response described in clause (i). (4) If an agency to which a report is submitted under paragraph (1) does not take the actions described in subparagraph (A) or (B) of paragraph (3), the Administrator shall— (A) initiate or complete appropriate action under section 6; or (B) take any action authorized or required under section 7, as applicable. (5) This subsection shall not relieve the Administrator of any obligation to take any appropriate action under section 6(a) or 7 to address risks from the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or any combination of those activities, that are not identified in a report issued by the Administrator under paragraph (1). ; (2) in subsection (b)— (A) by striking The Administrator shall coordinate and inserting (1) The Administrator shall coordinate ; and (B) by adding at the end the following: (2) In making a determination under paragraph (1) that it is in the public interest for the Administrator to take an action under this title with respect to a chemical substance or mixture rather than under another law administered in whole or in part by the Administrator, the Administrator shall consider, based on information reasonably available to the Administrator, all relevant aspects of the risk described in paragraph (1) and a comparison of the estimated costs and efficiencies of the action to be taken under this title and an action to be taken under such other law to protect against such risk. ; and (3) by adding at the end the following: (e) Exposure information In addition to the requirements of subsection (a), if the Administrator obtains information related to exposures or releases of a chemical substance or mixture that may be prevented or reduced under another Federal law, including a law not administered by the Administrator, the Administrator shall make such information available to the relevant Federal agency or office of the Environmental Protection Agency. . 10. Exports (a) In general Section 12(a)(2) of the Toxic Substances Control Act ( 15 U.S.C. 2611(a)(2) ) is amended by striking will present and inserting presents . (b) Prohibition on export of certain mercury compounds Section 12(c) of the Toxic Substances Control Act ( 15 U.S.C. 2611(c) ) is amended— (1) in the subsection heading, by inserting and Mercury Compounds after Mercury ; and (2) by adding at the end the following: (7) Prohibition on export of certain mercury compounds (A) In general Effective January 1, 2020, the export of the following mercury compounds is prohibited: (i) Mercury (I) chloride or calomel. (ii) Mercury (II) oxide. (iii) Mercury (II) sulfate. (iv) Mercury (II) nitrate. (v) Cinnabar or mercury sulphide. (vi) Any mercury compound that the Administrator adds to the list published under subparagraph (B) by rule, on determining that exporting that mercury compound for the purpose of regenerating elemental mercury is technically feasible. (B) Publication Not later than 90 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and as appropriate thereafter, the Administrator shall publish in the Federal Register a list of the mercury compounds that are prohibited from export under this paragraph. (C) Petition Any person may petition the Administrator to add a mercury compound to the list published under subparagraph (B). (D) Environmentally sound disposal This paragraph does not prohibit the export of mercury compounds on the list published under subparagraph (B) to member countries of the Organization for Economic Co-operation and Development for environmentally sound disposal, on the condition that no mercury or mercury compounds so exported are to be recovered, recycled, or reclaimed for use, or directly reused, after such export. (E) Report Not later than 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall evaluate any exports of mercury compounds on the list published under subparagraph (B) for disposal that occurred after such date of enactment and shall submit to Congress a report that— (i) describes volumes and sources of mercury compounds on the list published under subparagraph (B) exported for disposal; (ii) identifies receiving countries of such exports; (iii) describes methods of disposal used after such export; (iv) identifies issues, if any, presented by the export of mercury compounds on the list published under subparagraph (B); (v) includes an evaluation of management options in the United States for mercury compounds on the list published under subparagraph (B), if any, that are commercially available and comparable in cost and efficacy to methods being utilized in such receiving countries; and (vi) makes a recommendation regarding whether Congress should further limit or prohibit the export of mercury compounds on the list published under subparagraph (B) for disposal. (F) Effect on other law Nothing in this paragraph shall be construed to affect the authority of the Administrator under the Solid Waste Disposal Act ( 42 U.S.C. 6901 et seq. ). . (c) Temporary generator accumulation Section 5 of the Mercury Export Ban Act of 2008 ( 42 U.S.C. 6939f ) is amended— (1) in subsection (a)(2), by striking 2013 and inserting 2019 ; (2) in subsection (b)— (A) in paragraph (1)— (i) by redesignating subparagraphs (A), (B), and (C), as clauses (i), (ii), and (iii), respectively and indenting appropriately; (ii) in the first sentence, by striking After consultation and inserting the following: (A) Assessment and collection After consultation ; (iii) in the second sentence, by striking The amount of such fees and inserting the following: (B) Amount The amount of the fees described in subparagraph (A) ; (iv) in subparagraph (B) (as so designated)— (I) in clause (i) (as so redesignated), by striking publically available not later than October 1, 2012 and inserting publicly available not later than October 1, 2018 ; (II) in clause (ii) (as so redesignated), by striking and ; (III) in clause (iii) (as so redesignated), by striking the period at the end and inserting , subject to clause (iv); and ; and (IV) by adding at the end the following: (iv) for generators temporarily accumulating elemental mercury in a facility subject to subparagraphs (B) and (D)(iv) of subsection (g)(2) if the facility designated in subsection (a) is not operational by January 1, 2019, shall be adjusted to subtract the cost of the temporary accumulation during the period in which the facility designated under subsection (a) is not operational. ; and (v) by adding at the end the following: (C) Conveyance of title and permitting If the facility designated in subsection (a) is not operational by January 1, 2020, the Secretary— (i) shall immediately accept the conveyance of title to all elemental mercury that has accumulated in facilities in accordance with subsection (g)(2)(D), before January 1, 2020, and deliver the accumulated mercury to the facility designated under subsection (a) on the date on which the facility becomes operational; (ii) shall pay any applicable Federal permitting costs, including the costs for permits issued under section 3005(c) of the Solid Waste Disposal Act ( 42 U.S.C. 6925(c) ); and (iii) shall store, or pay the cost of storage of, until the time at which a facility designated in subsection (a) is operational, accumulated mercury to which the Secretary has title under this subparagraph in a facility that has been issued a permit under section 3005(c) of the Solid Waste Disposal Act ( 42 U.S.C. 6925(c) ). ; and (B) in paragraph (2), in the first sentence, by striking paragraph (1)(C) and inserting paragraph (1)(B)(iii) ; and (3) in subsection (g)(2)— (A) in the undesignated material at the end, by striking This subparagraph and inserting the following: (C) Subparagraph (B) ; (B) in subparagraph (C) (as designated by subparagraph (A)), by inserting of that subparagraph before the period at the end; and (C) by adding at the end the following: (D) A generator producing elemental mercury incidentally from the beneficiation or processing of ore or related pollution control activities may accumulate the mercury produced onsite that is destined for a facility designated by the Secretary under subsection (a) for more than 90 days without a permit issued under section 3005(c) of the Solid Waste Disposal Act ( 42 U.S.C. 6925(c) ), and shall not be subject to the storage prohibition of section 3004(j) of that Act ( 42 U.S.C. 6924(j) ), if— (i) the Secretary is unable to accept the mercury at a facility designated by the Secretary under subsection (a) for reasons beyond the control of the generator; (ii) the generator certifies in writing to the Secretary that the generator will ship the mercury to a designated facility when the Secretary is able to accept the mercury; (iii) the generator certifies in writing to the Secretary that the generator is storing only mercury the generator has produced or recovered onsite and will not sell, or otherwise place into commerce, the mercury; and (iv) the generator has obtained an identification number under section 262.12 of title 40, Code of Federal Regulations, and complies with the requirements described in paragraphs (1) through (4) of section 262.34(a) of title 40, Code of Federal Regulations (as in effect on the date of enactment of this subparagraph). (E) Management standards for temporary storage Not later than January 1, 2017, the Secretary, after consultation with the Administrator of the Environmental Protection Agency and State agencies in affected States, shall develop and make available guidance that establishes procedures and standards for the management and short-term storage of elemental mercury at a generator covered under subparagraph (D), including requirements to ensure appropriate use of flasks or other suitable containers. Such procedures and standards shall be protective of health and the environment and shall ensure that the elemental mercury is stored in a safe, secure, and effective manner. A generator may accumulate mercury in accordance with subparagraph (D) immediately upon enactment of this subparagraph, and notwithstanding that guidance called for by this paragraph has not been developed or made available. . (d) Interim status Section 5(d)(1) of the Mercury Export Ban Act of 2008 ( 42 U.S.C. 6939f(d)(1) ) is amended— (1) in the fourth sentence, by striking in existence on or before January 1, 2013, ; and (2) in the last sentence, by striking January 1, 2015 and inserting January 1, 2020 . 11. Confidential information Section 14 of the Toxic Substances Control Act ( 15 U.S.C. 2613 ) is amended to read as follows: 14. Confidential information (a) In general Except as provided in this section, the Administrator shall not disclose information that is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b)(4) of that section— (1) that is reported to, or otherwise obtained by, the Administrator under this Act; and (2) for which the requirements of subsection (c) are met. In any proceeding under section 552(a) of title 5, United States Code, to obtain information the disclosure of which has been denied because of the provisions of this subsection, the Administrator may not rely on section 552(b)(3) of such title to sustain the Administrator's action. (b) Information not protected from disclosure (1) Mixed confidential and nonconfidential information Information that is protected from disclosure under this section, and which is mixed with information that is not protected from disclosure under this section, does not lose its protection from disclosure notwithstanding that it is mixed with information that is not protected from disclosure. (2) Information from health and safety studies Subsection (a) does not prohibit the disclosure of— (A) any health and safety study which is submitted under this Act with respect to— (i) any chemical substance or mixture which, on the date on which such study is to be disclosed has been offered for commercial distribution; or (ii) any chemical substance or mixture for which testing is required under section 4 or for which notification is required under section 5; and (B) any information reported to, or otherwise obtained by, the Administrator from a health and safety study which relates to a chemical substance or mixture described in clause (i) or (ii) of subparagraph (A). This paragraph does not authorize the disclosure of any information, including formulas (including molecular structures) of a chemical substance or mixture, that discloses processes used in the manufacturing or processing of a chemical substance or mixture or, in the case of a mixture, the portion of the mixture comprised by any of the chemical substances in the mixture. (3) Other information not protected from disclosure Subsection (a) does not prohibit the disclosure of— (A) any general information describing the manufacturing volumes, expressed as specific aggregated volumes or, if the Administrator determines that disclosure of specific aggregated volumes would reveal confidential information, expressed in ranges; or (B) a general description of a process used in the manufacture or processing and industrial, commercial, or consumer functions and uses of a chemical substance, mixture, or article containing a chemical substance or mixture, including information specific to an industry or industry sector that customarily would be shared with the general public or within an industry or industry sector. (4) Bans and phase-outs (A) In general If the Administrator promulgates a rule pursuant to section 6(a) that establishes a ban or phase-out of a chemical substance or mixture, the protection from disclosure of any information under this section with respect to the chemical substance or mixture shall be presumed to no longer apply, subject to subsection (g)(1)(E) and subparagraphs (B) and (C) of this paragraph. (B) Limitations (i) Critical use In the case of a chemical substance or mixture for which a specific condition of use is subject to an exemption pursuant to section 6(g), if the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to information that relates solely to any conditions of use of the chemical substance or mixture to which the exemption does not apply. (ii) Export In the case of a chemical substance or mixture for which there is manufacture, processing, or distribution in commerce that meets the conditions of section 12(a)(1), if the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to information that relates solely to any other manufacture, processing, or distribution in commerce of the chemical substance or mixture for the conditions of use subject to the ban or phase-out, unless the Administrator makes the determination in section 12(a)(2). (iii) Specific conditions of use In the case of a chemical substance or mixture for which the Administrator establishes a ban or phase-out described in subparagraph (A) with respect to a specific condition of use of the chemical substance or mixture, the presumption against protection under such subparagraph shall only apply to information that relates solely to the condition of use of the chemical substance or mixture for which the ban or phase-out is established. (C) Request for nondisclosure (i) In general A manufacturer or processor of a chemical substance or mixture subject to a ban or phase-out described in this paragraph may submit to the Administrator, within 30 days of receiving a notification under subsection (g)(2)(A), a request, including documentation supporting such request, that some or all of the information to which the notice applies should not be disclosed or that its disclosure should be delayed, and the Administrator shall review the request under subsection (g)(1)(E). (ii) Effect of no request or denial If no request for nondisclosure or delay is submitted to the Administrator under this subparagraph, or the Administrator denies such a request under subsection (g)(1)(A), the information shall not be protected from disclosure under this section. (5) Certain requests If a request is made to the Administrator under section 552(a) of title 5, United States Code, for information reported to or otherwise obtained by the Administrator under this Act that is not protected from disclosure under this subsection, the Administrator may not deny the request on the basis of section 552(b)(4) of title 5, United States Code. (c) Requirements for confidentiality claims (1) Assertion of claims (A) In general A person seeking to protect from disclosure any information that person submits under this Act (including information described in paragraph (2)) shall assert to the Administrator a claim for protection from disclosure concurrent with submission of the information, in accordance with such rules regarding a claim for protection from disclosure as the Administrator has promulgated or may promulgate pursuant to this title. (B) Inclusion An assertion of a claim under subparagraph (A) shall include a statement that the person has— (i) taken reasonable measures to protect the confidentiality of the information; (ii) determined that the information is not required to be disclosed or otherwise made available to the public under any other Federal law; (iii) a reasonable basis to conclude that disclosure of the information is likely to cause substantial harm to the competitive position of the person; and (iv) a reasonable basis to believe that the information is not readily discoverable through reverse engineering. (C) Additional requirements for claims regarding chemical identity information In the case of a claim under subparagraph (A) for protection from disclosure of a specific chemical identity, the claim shall include a structurally descriptive generic name for the chemical substance that the Administrator may disclose to the public, subject to the condition that such generic name shall— (i) be consistent with guidance developed by the Administrator under paragraph (4)(A); and (ii) describe the chemical structure of the chemical substance as specifically as practicable while protecting those features of the chemical structure— (I) that are claimed as confidential; and (II) the disclosure of which would be likely to cause substantial harm to the competitive position of the person. (2) Information generally not subject to substantiation requirements Subject to subsection (f), the following information shall not be subject to substantiation requirements under paragraph (3): (A) Specific information describing the processes used in manufacture or processing of a chemical substance, mixture, or article. (B) Marketing and sales information. (C) Information identifying a supplier or customer. (D) In the case of a mixture, details of the full composition of the mixture and the respective percentages of constituents. (E) Specific information regarding the use, function, or application of a chemical substance or mixture in a process, mixture, or article. (F) Specific production or import volumes of the manufacturer or processor. (G) Prior to the date on which a chemical substance is first offered for commercial distribution, the specific chemical identity of the chemical substance, including the chemical name, molecular formula, Chemical Abstracts Service number, and other information that would identify the specific chemical substance, if the specific chemical identity was claimed as confidential at the time it was submitted in a notice under section 5. (3) Substantiation requirements Except as provided in paragraph (2), a person asserting a claim to protect information from disclosure under this section shall substantiate the claim, in accordance with such rules as the Administrator has promulgated or may promulgate pursuant to this section. (4) Guidance The Administrator shall develop guidance regarding— (A) the determination of structurally descriptive generic names, in the case of claims for the protection from disclosure of specific chemical identity; and (B) the content and form of the statements of need and agreements required under paragraphs (4), (5), and (6) of subsection (d). (5) Certification An authorized official of a person described in paragraph (1)(A) shall certify that the statement required to assert a claim submitted pursuant to paragraph (1)(B), and any information required to substantiate a claim submitted pursuant to paragraph (3), are true and correct. (d) Exceptions to protection from disclosure Information described in subsection (a)— (1) shall be disclosed to an officer or employee of the United States— (A) in connection with the official duties of that person under any Federal law for the protection of health or the environment; or (B) for a specific Federal law enforcement purpose; (2) shall be disclosed to a contractor of the United States and employees of that contractor— (A) if, in the opinion of the Administrator, the disclosure is necessary for the satisfactory performance by the contractor of a contract with the United States for the performance of work in connection with this Act; and (B) subject to such conditions as the Administrator may specify; (3) shall be disclosed if the Administrator determines that disclosure is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use; (4) shall be disclosed to a State, political subdivision of a State, or tribal government, on written request, for the purpose of administration or enforcement of a law, if such entity has 1 or more applicable agreements with the Administrator that are consistent with the guidance developed under subsection (c)(4)(B) and ensure that the entity will take appropriate measures, and has adequate authority, to maintain the confidentiality of the information in accordance with procedures comparable to the procedures used by the Administrator to safeguard the information; (5) shall be disclosed to a health or environmental professional employed by a Federal or State agency or tribal government or a treating physician or nurse in a nonemergency situation if such person provides a written statement of need and agrees to sign a written confidentiality agreement with the Administrator, subject to the conditions that— (A) the statement of need and confidentiality agreement are consistent with the guidance developed under subsection (c)(4)(B); (B) the statement of need shall be a statement that the person has a reasonable basis to suspect that— (i) the information is necessary for, or will assist in— (I) the diagnosis or treatment of 1 or more individuals; or (II) responding to an environmental release or exposure; and (ii) 1 or more individuals being diagnosed or treated have been exposed to the chemical substance or mixture concerned, or an environmental release of or exposure to the chemical substance or mixture concerned has occurred; and (C) the person will not use the information for any purpose other than the health or environmental needs asserted in the statement of need, except as otherwise may be authorized by the terms of the agreement or by the person who has a claim under this section with respect to the information; (6) shall be disclosed in the event of an emergency to a treating or responding physician, nurse, agent of a poison control center, public health or environmental official of a State, political subdivision of a State, or tribal government, or first responder (including any individual duly authorized by a Federal agency, State, political subdivision of a State, or tribal government who is trained in urgent medical care or other emergency procedures, including a police officer, firefighter, or emergency medical technician) if such person requests the information, subject to the conditions that such person shall— (A) have a reasonable basis to suspect that— (i) a medical, public health, or environmental emergency exists; (ii) the information is necessary for, or will assist in, emergency or first-aid diagnosis or treatment; or (iii) 1 or more individuals being diagnosed or treated have likely been exposed to the chemical substance or mixture concerned, or a serious environmental release of or exposure to the chemical substance or mixture concerned has occurred; and (B) if requested by a person who has a claim with respect to the information under this section— (i) provide a written statement of need and agree to sign a confidentiality agreement, as described in paragraph (5); and (ii) submit to the Administrator such statement of need and confidentiality agreement as soon as practicable, but not necessarily before the information is disclosed; (7) may be disclosed if the Administrator determines that disclosure is relevant in a proceeding under this Act, subject to the condition that the disclosure is made in such a manner as to preserve confidentiality to the extent practicable without impairing the proceeding; (8) shall be disclosed if the information is required to be made public under any other provision of Federal law; and (9) shall be disclosed as required pursuant to discovery, subpoena, other court order, or any other judicial process otherwise allowed under applicable Federal or State law. (e) Duration of protection from disclosure (1) In general Subject to paragraph (2), subsection (f)(3), and section 8(b), the Administrator shall protect from disclosure information described in subsection (a)— (A) in the case of information described in subsection (c)(2), until such time as— (i) the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the information shall not be protected from disclosure under this section; or (ii) the Administrator becomes aware that the information does not qualify for protection from disclosure under this section, in which case the Administrator shall take any actions required under subsections (f) and (g); and (B) in the case of information other than information described in subsection (c)(2)— (i) for a period of 10 years from the date on which the person asserts the claim with respect to the information submitted to the Administrator; or (ii) if applicable before the expiration of such 10-year period, until such time as— (I) the person that asserted the claim notifies the Administrator that the person is withdrawing the claim, in which case the information shall not be protected from disclosure under this section; or (II) the Administrator becomes aware that the information does not qualify for protection from disclosure under this section, in which case the Administrator shall take any actions required under subsections (f) and (g). (2) Extensions (A) In general In the case of information other than information described in subsection (c)(2), not later than the date that is 60 days before the expiration of the period described in paragraph (1)(B)(i), the Administrator shall provide to the person that asserted the claim a notice of the impending expiration of the period. (B) Request (i) In general Not later than the date that is 30 days before the expiration of the period described in paragraph (1)(B)(i), a person reasserting the relevant claim shall submit to the Administrator a request for extension substantiating, in accordance with subsection (c)(3), the need to extend the period. (ii) Action by Administrator Not later than the date of expiration of the period described in paragraph (1)(B)(i), the Administrator shall, in accordance with subsection (g)(1)— (I) review the request submitted under clause (i); (II) make a determination regarding whether the claim for which the request was submitted continues to meet the relevant requirements of this section; and (III) (aa) grant an extension of 10 years; or (bb) deny the request. (C) No limit on number of extensions There shall be no limit on the number of extensions granted under this paragraph, if the Administrator determines that the relevant request under subparagraph (B)(i)— (i) establishes the need to extend the period; and (ii) meets the requirements established by the Administrator. (f) Review and resubstantiation (1) Discretion of Administrator The Administrator may require any person that has claimed protection for information from disclosure under this section, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , to reassert and substantiate or resubstantiate the claim in accordance with this section— (A) after the chemical substance is designated as a high-priority substance under section 6(b); (B) for any chemical substance designated as an active substance under section 8(b)(5)(B)(iii); or (C) if the Administrator determines that disclosure of certain information currently protected from disclosure would be important to assist the Administrator in conducting risk evaluations or promulgating rules under section 6. (2) Review required The Administrator shall review a claim for protection of information from disclosure under this section and require any person that has claimed protection for that information, whether before, on, or after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , to reassert and substantiate or resubstantiate the claim in accordance with this section— (A) as necessary to determine whether the information qualifies for an exemption from disclosure in connection with a request for information received by the Administrator under section 552 of title 5, United States Code; (B) if the Administrator has a reasonable basis to believe that the information does not qualify for protection from disclosure under this section; or (C) for any chemical substance the Administrator determines under section 6(b)(4)(A) presents an unreasonable risk of injury to health or the environment. (3) Period of protection If the Administrator requires a person to reassert and substantiate or resubstantiate a claim under this subsection, and determines that the claim continues to meet the relevant requirements of this section, the Administrator shall protect the information subject to the claim from disclosure for a period of 10 years from the date of such determination, subject to any subsequent requirement by the Administrator under this subsection. (g) Duties of Administrator (1) Determination (A) In general Except for claims regarding information described in subsection (c)(2), the Administrator shall, subject to subparagraph (C), not later than 90 days after the receipt of a claim under subsection (c), and not later than 30 days after the receipt of a request for extension of a claim under subsection (e) or a request under subsection (b)(4)(C), review and approve, approve in part and deny in part, or deny the claim or request. (B) Reasons for denial If the Administrator denies or denies in part a claim or request under subparagraph (A) the Administrator shall provide to the person that asserted the claim or submitted the request a written statement of the reasons for the denial or denial in part of the claim or request. (C) Subsets The Administrator shall— (i) except with respect to information described in subsection (c)(2)(G), review all claims or requests under this section for the protection from disclosure of the specific chemical identity of a chemical substance; and (ii) review a representative subset, comprising at least 25 percent, of all other claims or requests for protection from disclosure under this section. (D) Effect of failure to act The failure of the Administrator to make a decision regarding a claim or request for protection from disclosure or extension under this section shall not have the effect of denying or eliminating a claim or request for protection from disclosure. (E) Determination of requests under subsection ( b )( 4 )( C ) With respect to a request submitted under subsection (b)(4)(C), the Administrator shall, with the objective of ensuring that information relevant to the protection of health and the environment is disclosed to the extent practicable, determine whether the documentation provided by the person rebuts what shall be the presumption of the Administrator that the public interest in the disclosure of the information outweighs the public or proprietary interest in maintaining the protection for all or a portion of the information that the person has requested not be disclosed or for which disclosure be delayed. (2) Notification (A) In general Except as provided in subparagraph (B) and subsections (b), (d), and (e), if the Administrator denies or denies in part a claim or request under paragraph (1), concludes, in accordance with this section, that the information does not qualify for protection from disclosure, intends to disclose information pursuant to subsection (d), or promulgates a rule under section 6(a) establishing a ban or phase-out with respect to a chemical substance or mixture, the Administrator shall notify, in writing, the person that asserted the claim or submitted the request of the intent of the Administrator to disclose the information or not protect the information from disclosure under this section. The notice shall be furnished by certified mail (return receipt requested), by personal delivery, or by other means that allows verification of the fact and date of receipt. (B) Disclosure of information Except as provided in subparagraph (C), the Administrator shall not disclose information under this subsection until the date that is 30 days after the date on which the person that asserted the claim or submitted the request receives notification under subparagraph (A). (C) Exceptions (i) Fifteen day notification For information the Administrator intends to disclose under subsections (d)(3), (d)(4), (d)(5), and (j), the Administrator shall not disclose the information until the date that is 15 days after the date on which the person that asserted the claim or submitted the request receives notification under subparagraph (A), except that, with respect to information to be disclosed under subsection (d)(3), if the Administrator determines that disclosure of the information is necessary to protect against an imminent and substantial harm to health or the environment, no prior notification shall be necessary. (ii) Notification as soon as practicable For information the Administrator intends to disclose under paragraph (6) of subsection (d), the Administrator shall notify the person that submitted the information that the information has been disclosed as soon as practicable after disclosure of the information. (iii) No notification required Notification shall not be required— (I) for the disclosure of information under paragraphs (1), (2), (7), or (8) of subsection (d); or (II) for the disclosure of information for which— (aa) the Administrator has provided to the person that asserted the claim a notice under subsection (e)(2)(A); and (bb) such person does not submit to the Administrator a request under subsection (e)(2)(B) on or before the deadline established in subsection (e)(2)(B)(i). (D) Appeals (i) Action to restrain disclosure If a person receives a notification under this paragraph and believes the information is protected from disclosure under this section, before the date on which the information is to be disclosed pursuant to subparagraph (B) or (C) the person may bring an action to restrain disclosure of the information in— (I) the United States district court of the district in which the complainant resides or has the principal place of business; or (II) the United States District Court for the District of Columbia. (ii) No disclosure (I) In general Subject to subsection (d), the Administrator shall not disclose information that is the subject of an appeal under this paragraph before the date on which the applicable court rules on an action under clause (i). (II) Exception Subclause (I) shall not apply to disclosure of information described under subsections (d)(4) and (j). (3) Request and notification system The Administrator, in consultation with the Director of the Centers for Disease Control and Prevention, shall develop a request and notification system that, in a format and language that is readily accessible and understandable, allows for expedient and swift access to information disclosed pursuant to paragraphs (5) and (6) of subsection (d). (4) Unique identifier The Administrator shall— (A) (i) develop a system to assign a unique identifier to each specific chemical identity for which the Administrator approves a request for protection from disclosure, which shall not be either the specific chemical identity or a structurally descriptive generic term; and (ii) apply that identifier consistently to all information relevant to the applicable chemical substance; (B) annually publish and update a list of chemical substances, referred to by their unique identifiers, for which claims to protect the specific chemical identity from disclosure have been approved, including the expiration date for each such claim; (C) ensure that any nonconfidential information received by the Administrator with respect to a chemical substance included on the list published under subparagraph (B) while the specific chemical identity of the chemical substance is protected from disclosure under this section identifies the chemical substance using the unique identifier; and (D) for each claim for protection of a specific chemical identity that has been denied by the Administrator or expired, or that has been withdrawn by the person who asserted the claim, and for which the Administrator has used a unique identifier assigned under this paragraph to protect the specific chemical identity in information that the Administrator has made public, clearly link the specific chemical identity to the unique identifier in such information to the extent practicable. (h) Criminal penalty for wrongful disclosure (1) Individuals subject to penalty (A) In general Subject to subparagraph (C) and paragraph (2), an individual described in subparagraph (B) shall be fined under title 18, United States Code, or imprisoned for not more than 1 year, or both. (B) Description An individual referred to in subparagraph (A) is an individual who— (i) pursuant to this section, obtained possession of, or has access to, information protected from disclosure under this section; and (ii) knowing that the information is protected from disclosure under this section, willfully discloses the information in any manner to any person not entitled to receive that information. (C) Exception This paragraph shall not apply to any medical professional (including an emergency medical technician or other first responder) who discloses any information obtained under paragraph (5) or (6) of subsection (d) to a patient treated by the medical professional, or to a person authorized to make medical or health care decisions on behalf of such a patient, as needed for the diagnosis or treatment of the patient. (2) Other laws Section 1905 of title 18, United States Code, shall not apply with respect to the publishing, divulging, disclosure, or making known of, or making available, information reported to or otherwise obtained by the Administrator under this Act. (i) Applicability (1) In general Except as otherwise provided in this section, section 8, or any other applicable Federal law, the Administrator shall have no authority— (A) to require the substantiation or resubstantiation of a claim for the protection from disclosure of information reported to or otherwise obtained by the Administrator under this Act prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ; or (B) to impose substantiation or resubstantiation requirements, with respect to the protection of information described in subsection (a), under this Act that are more extensive than those required under this section. (2) Actions prior to promulgation of rules Nothing in this Act prevents the Administrator from reviewing, requiring substantiation or resubstantiation of, or approving, approving in part, or denying any claim for the protection from disclosure of information before the effective date of such rules applicable to those claims as the Administrator may promulgate after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (j) Access by Congress Notwithstanding any limitation contained in this section or any other provision of law, all information reported to or otherwise obtained by the Administrator (or any representative of the Administrator) under this Act shall be made available, upon written request of any duly authorized committee of the Congress, to such committee. . 12. Penalties Section 16 of the Toxic Substances Control Act ( 15 U.S.C. 2615 ) is amended— (1) in subsection (a)(1), by striking $25,000 and inserting $37,500 ; and (2) in subsection (b)— (A) by striking Any person and inserting the following: (1) In general Any person ; (B) by striking $25,000 and inserting $50,000 ; and (C) by adding at the end the following: (2) Imminent danger of death or serious bodily injury (A) In general Any person who knowingly and willfully violates any provision of section 15 or 409, and who knows at the time of the violation that the violation places an individual in imminent danger of death or serious bodily injury, shall be subject on conviction to a fine of not more than $250,000, or imprisonment for not more than 15 years, or both. (B) Organizations Notwithstanding the penalties described in subparagraph (A), an organization that commits a knowing violation described in subparagraph (A) shall be subject on conviction to a fine of not more than $1,000,000 for each violation. (C) Incorporation of corresponding provisions Subparagraphs (B) through (F) of section 113(c)(5) of the Clean Air Act ( 42 U.S.C. 7413(c)(5)(B) –(F)) shall apply to the prosecution of a violation under this paragraph. . 13. State-Federal relationship Section 18 of the Toxic Substances Control Act ( 15 U.S.C. 2617 ) is amended— (1) by amending subsection (a) to read as follows: (a) In general (1) Establishment or enforcement Except as otherwise provided in subsections (c), (d), (e), (f), and (g), and subject to paragraph (2), no State or political subdivision of a State may establish or continue to enforce any of the following: (A) Development of information A statute or administrative action to require the development of information about a chemical substance or category of chemical substances that is reasonably likely to produce the same information required under section 4, 5, or 6 in— (i) a rule promulgated by the Administrator; (ii) a consent agreement entered into by the Administrator; or (iii) an order issued by the Administrator. (B) Chemical substances found not to present an unreasonable risk or restricted A statute, criminal penalty, or administrative action to prohibit or otherwise restrict the manufacture, processing, or distribution in commerce or use of a chemical substance— (i) for which the determination described in section 6(i)(1) is made, consistent with the scope of the risk evaluation under section (6)(b)(4)(D); or (ii) for which a final rule is promulgated under section 6(a), after the effective date of the rule issued under section 6(a) for the chemical substance, consistent with the scope of the risk evaluation under section (6)(b)(4)(D). (C) Significant new use A statute or administrative action requiring the notification of a use of a chemical substance that the Administrator has specified as a significant new use and for which the Administrator has required notification pursuant to a rule promulgated under section 5. (2) Effective date of preemption Under this subsection, Federal preemption of statutes and administrative actions applicable to specific chemical substances shall not occur until the effective date of the applicable action described in paragraph (1) taken by the Administrator. ; (2) by amending subsection (b) to read as follows: (b) New statutes, criminal penalties, or administrative actions creating prohibitions or other restrictions (1) In general Except as provided in subsections (c), (d), (e), (f), and (g), beginning on the date on which the Administrator defines the scope of a risk evaluation for a chemical substance under section 6(b)(4)(D) and ending on the date on which the deadline established pursuant to section 6(b)(4)(G) for completion of the risk evaluation expires, or on the date on which the Administrator publishes the risk evaluation under section 6(b)(4)(C), whichever is earlier, no State or political subdivision of a State may establish a statute, criminal penalty, or administrative action prohibiting or otherwise restricting the manufacture, processing, distribution in commerce, or use of such chemical substance that is a high-priority substance designated under section 6(b)(1)(B)(i). (2) Effect of subsection This subsection does not restrict the authority of a State or political subdivision of a State to continue to enforce any statute enacted, criminal penalty assessed, or administrative action taken, prior to the date on which the Administrator defines and publishes the scope of a risk evaluation under section 6(b)(4)(D). ; and (3) by adding at the end the following: (c) Scope of preemption Federal preemption under subsections (a) and (b) of statutes, criminal penalties, and administrative actions applicable to specific chemical substances shall apply only to— (1) with respect to subsection (a)(1)(A), the chemical substances or category of chemical substances subject to a rule, order, or consent agreement under section 4, 5, or 6; (2) with respect to subsection (b), the hazards, exposures, risks, and uses or conditions of use of such chemical substances included in the scope of the risk evaluation pursuant to section 6(b)(4)(D); (3) with respect to subsection (a)(1)(B), the hazards, exposures, risks, and uses or conditions of use of such chemical substances included in any final action the Administrator takes pursuant to section 6(a) or 6(i)(1); or (4) with respect to subsection (a)(1)(C), the uses of such chemical substances that the Administrator has specified as significant new uses and for which the Administrator has required notification pursuant to a rule promulgated under section 5. (d) Exceptions (1) No preemption of statutes and administrative actions (A) In general Nothing in this Act, nor any amendment made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act , nor any rule, standard of performance, risk evaluation, or scientific assessment implemented pursuant to this Act, shall affect the right of a State or a political subdivision of a State to adopt or enforce any rule, standard of performance, risk evaluation, scientific assessment, or any other protection for public health or the environment that— (i) is adopted or authorized under the authority of any other Federal law or adopted to satisfy or obtain authorization or approval under any other Federal law; (ii) implements a reporting, monitoring, or other information obligation for the chemical substance not otherwise required by the Administrator under this Act or required under any other Federal law; (iii) is adopted pursuant to authority under a law of the State or political subdivision of the State related to water quality, air quality, or waste treatment or disposal, except to the extent that the action— (I) imposes a restriction on the manufacture, processing, distribution in commerce, or use of a chemical substance; and (II) (aa) addresses the same hazards and exposures, with respect to the same conditions of use as are included in the scope of the risk evaluation published pursuant to section 6(b)(4)(D), but is inconsistent with the action of the Administrator; or (bb) would cause a violation of the applicable action by the Administrator under section 5 or 6; or (iv) subject to subparagraph (B), is identical to a requirement prescribed by the Administrator. (B) Identical requirements (i) In general The penalties and other sanctions applicable under a law of a State or political subdivision of a State in the event of noncompliance with the identical requirement shall be no more stringent than the penalties and other sanctions available to the Administrator under section 16 of this Act. (ii) Penalties In the case of an identical requirement— (I) a State or political subdivision of a State may not assess a penalty for a specific violation for which the Administrator has assessed an adequate penalty under section 16; and (II) if a State or political subdivision of a State has assessed a penalty for a specific violation, the Administrator 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 or political subdivision of a State and the Administrator combined to exceed the maximum amount that may be assessed for that violation by the Administrator under section 16. (2) Applicability to certain rules or orders (A) Prior rules and orders Nothing in this section shall be construed as modifying the preemptive effect under this section, as in effect on the day before the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , of any rule or order promulgated or issued under this Act prior to that effective date. (B) Certain chemical substances and mixtures With respect to a chemical substance or mixture for which any rule or order was promulgated or issued under section 6 prior to the effective date of the Frank R. Lautenberg Chemical Safety for the 21st Century Act with respect to manufacturing, processing, distribution in commerce, use, or disposal of the chemical substance or mixture, nothing in this section shall be construed as modifying the preemptive effect of this section as in effect prior to the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act of any rule or order that is promulgated or issued with respect to such chemical substance or mixture under section 6 after that effective date, unless the latter rule or order is with respect to a chemical substance or mixture containing a chemical substance and follows a designation of that chemical substance as a high-priority substance under section 6(b)(1)(B)(i), the identification of that chemical substance under section 6(b)(2)(A), or the selection of that chemical substance for risk evaluation under section 6(b)(4)(E)(iv)(II). (e) Preservation of certain laws (1) In general Nothing in this Act, subject to subsection (g) of this section, shall— (A) be construed to preempt or otherwise affect the authority of a State or political subdivision of a State to continue to enforce any action taken or requirement imposed or requirement enacted relating to a specific chemical substance before April 22, 2016, under the authority of a law of the State or political subdivision of the State that prohibits or otherwise restricts manufacturing, processing, distribution in commerce, use, or disposal of a chemical substance; or (B) be construed to preempt or otherwise affect any action taken pursuant to a State law that was in effect on August 31, 2003. (2) Effect of subsection This subsection does not affect, modify, or alter the relationship between Federal law and laws of a State or political subdivision of a State pursuant to any other Federal law. (f) Waivers (1) Discretionary exemptions Upon application of a State or political subdivision of a State, the Administrator may, by rule, exempt from subsection (a), under such conditions as may be prescribed in the rule, a statute, criminal penalty, or administrative action of that State or political subdivision of the State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that— (A) compelling conditions warrant granting the waiver to protect health or the environment; (B) compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; (C) compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and (D) in the judgment of the Administrator, the proposed requirement of the State or political subdivision of the State is designed to address a risk of a chemical substance, under the conditions of use, that was identified— (i) consistent with the best available science; (ii) using supporting studies conducted in accordance with sound and objective scientific practices; and (iii) based on the weight of the scientific evidence. (2) Required exemptions Upon application of a State or political subdivision of a State, the Administrator shall exempt from subsection (b) a statute or administrative action of a State or political subdivision of a State that relates to the effects of exposure to a chemical substance under the conditions of use if the Administrator determines that— (A) (i) compliance with the proposed requirement of the State or political subdivision of the State would not unduly burden interstate commerce in the manufacture, processing, distribution in commerce, or use of a chemical substance; (ii) compliance with the proposed requirement of the State or political subdivision of the State would not cause a violation of any applicable Federal law, rule, or order; and (iii) the State or political subdivision of the State has a concern about the chemical substance or use of the chemical substance based in peer-reviewed science; or (B) no later than the date that is 18 months after the date on which the Administrator has initiated the prioritization process for a chemical substance under the rule promulgated pursuant to section 6(b)(1)(A), or the date on which the Administrator publishes the scope of the risk evaluation for a chemical substance under section 6(b)(4)(D), whichever is sooner, the State or political subdivision of the State has enacted a statute or proposed or finalized an administrative action intended to prohibit or otherwise restrict the manufacture, processing, distribution in commerce, or use of the chemical substance. (3) Determination of a waiver request The duty of the Administrator to grant or deny a waiver application shall be nondelegable and shall be exercised— (A) not later than 180 days after the date on which an application under paragraph (1) is submitted; and (B) not later than 110 days after the date on which an application under paragraph (2) is submitted. (4) Failure to make a determination If the Administrator fails to make a determination under paragraph (3)(B) during the 110-day period beginning on the date on which an application under paragraph (2) is submitted, the statute or administrative action of the State or political subdivision of the State that was the subject of the application shall not be considered to be an existing statute or administrative action for purposes of subsection (b) by reason of the failure of the Administrator to make a determination. (5) Notice and comment Except in the case of an application approved under paragraph (9), the application of a State or political subdivision of a State under this subsection shall be subject to public notice and comment. (6) Final agency action The decision of the Administrator on the application of a State or political subdivision of a State shall be— (A) considered to be a final agency action; and (B) subject to judicial review. (7) Duration of waivers A waiver granted under paragraph (2) or approved under paragraph (9) shall remain in effect until such time as the Administrator publishes the risk evaluation under section 6(b). (8) Judicial review of waivers Not later than 60 days after the date on which the Administrator makes a determination on an application of a State or political subdivision of a State under paragraph (1) or (2), any person may file a petition for judicial review in the United States Court of Appeals for the District of Columbia Circuit, which shall have exclusive jurisdiction over the determination. (9) Approval (A) Automatic approval If the Administrator fails to meet the deadline established under paragraph (3)(B), the application of a State or political subdivision of a State under paragraph (2) shall be automatically approved, effective on the date that is 10 days after the deadline. (B) Requirements Notwithstanding paragraph (6), approval of a waiver application under subparagraph (A) for failure to meet the deadline under paragraph (3)(B) shall not be considered final agency action or be subject to judicial review or public notice and comment. (g) Savings (1) No preemption of common law or statutory causes of action for civil relief or criminal conduct (A) In general Nothing in this Act, nor any amendment made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act , nor any standard, rule, requirement, standard of performance, risk evaluation, or scientific assessment implemented pursuant to this Act, shall be construed to preempt, displace, or supplant any State or Federal common law rights or any State or Federal statute creating a remedy for civil relief, including those for civil damage, or a penalty for a criminal conduct. (B) Clarification of no preemption Notwithstanding any other provision of this Act, nothing in this Act, nor any amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act , shall preempt or preclude any cause of action for personal injury, wrongful death, property damage, or other injury based on negligence, strict liability, products liability, failure to warn, or any other legal theory of liability under any State law, maritime law, or Federal common law or statutory theory. (2) No effect on private remedies (A) In general Nothing in this Act, nor any amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act , nor any rules, regulations, requirements, risk evaluations, scientific assessments, or orders issued pursuant to this Act shall be interpreted as, in either the plaintiff’s or defendant’s favor, dispositive in any civil action. (B) Authority of courts This Act does not affect the authority of any court to make a determination in an adjudicatory proceeding under applicable State or Federal law with respect to the admission into evidence or any other use of this Act or rules, regulations, requirements, standards of performance, risk evaluations, scientific assessments, or orders issued pursuant to this Act. . 14. Judicial review Section 19(a) of the Toxic Substances Control Act ( 15 U.S.C. 2618(a) ) is amended— (1) in paragraph (1), by adding at the end the following: (C) (i) Not later than 60 days after the publication of a designation under section 6(b)(1)(B)(ii), any person may commence a civil action to challenge the designation. (ii) The United States Court of Appeals for the District of Columbia Circuit shall have exclusive jurisdiction over a civil action filed under this subparagraph. ; and (2) by striking paragraph (3). 15. Citizens’ civil actions Section 20(b) of the Toxic Substances Control Act ( 15 U.S.C. 2619(b) ) is amended— (1) in paragraph (1)(B), by striking or at the end; and (2) in paragraph (2), by striking the period at the end and inserting the following: , except that no prior notification shall be required in the case of a civil action brought to compel a decision by the Administrator pursuant to section 18(f)(3)(B); or (3) in the case of a civil action brought to compel a decision by the Administrator pursuant to section 18(f)(3)(B), after the date that is 60 days after the deadline specified in section 18(f)(3)(B). . 16. Studies Section 25 of the Toxic Substances Control Act ( 15 U.S.C. 2624 ) is repealed. 17. Administration of the Act Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) in subsection (b)(1)— (A) by striking of a reasonable fee ; (B) by striking data under section 4 or 5 to defray the cost of administering this Act and inserting information under section 4 or a notice or other information to be reviewed by the Administrator under section 5, or who manufactures or processes a chemical substance that is the subject of a risk evaluation under section 6(b), of a fee that is sufficient and not more than reasonably necessary to defray the cost related to such chemical substance of administering sections 4, 5, and 6, and collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, including contractor costs incurred by the Administrator ; (C) by striking Such rules shall not provide for any fee in excess of $2,500 or, in the case of a small business concern, any fee in excess of $100. ; and (D) by striking submit the data and the cost to the Administrator of reviewing such data and inserting pay such fee and the cost to the Administrator of carrying out the activities described in this paragraph ; (2) in subsection (b)— (A) in paragraph (2), by striking paragraph (1) and inserting paragraph (4) ; and (B) by adding at the end the following: (3) Fund (A) Establishment There is established in the Treasury of the United States a fund, to be known as the TSCA Service Fee Fund (in this paragraph referred to as the Fund ), consisting of such amounts as are deposited in the Fund under this paragraph. (B) Collection and deposit of fees Subject to the conditions of subparagraph (C), the Administrator shall collect the fees described in this subsection and deposit those fees in the Fund. (C) Use of funds by Administrator Fees authorized under this section shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts, and shall be available without fiscal year limitation for use in defraying the costs of the activities described in paragraph (1). (D) Accounting and auditing (i) Accounting The Administrator shall biennially prepare and submit to the Committee on Environment and Public Works of the Senate and the Committee on Energy and Commerce of the House of Representatives a report that includes an accounting of the fees paid to the Administrator under this paragraph and amounts disbursed from the Fund for the period covered by the report, as reflected by financial statements provided in accordance with sections 3515 and 3521 of title 31, United States Code. (ii) Auditing (I) In general For the purpose of section 3515(c) of title 31, United States Code, the Fund shall be considered a component of a covered executive agency. (II) Components of audit The annual audit required in accordance with sections 3515 and 3521 of title 31, United States Code, of the financial statements of activities carried out using amounts from the Fund shall include an analysis of— (aa) the fees collected and amounts disbursed under this subsection; (bb) the reasonableness of the fees in place as of the date of the audit to meet current and projected costs of administering the provisions of this title for which the fees may be used; and (cc) the number of requests for a risk evaluation made by manufacturers under section 6(b)(4)(C)(ii). (III) Federal responsibility The Inspector General of the Environmental Protection Agency shall conduct the annual audit described in subclause (II) and submit to the Administrator a report that describes the findings and any recommendations of the Inspector General resulting from the audit. (4) Amount and adjustment of fees; refunds In setting fees under this section, the Administrator shall— (A) prescribe lower fees for small business concerns, after consultation with the Administrator of the Small Business Administration; (B) set the fees established under paragraph (1) at levels such that the fees will, in aggregate, provide a sustainable source of funds to annually defray— (i) the lower of— (I) 25 percent of the costs to the Administrator of carrying out sections 4, 5, and 6, and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, other than the costs to conduct and complete risk evaluations under section 6(b); or (II) $25,000,000 (subject to adjustment pursuant to subparagraph (F)); and (ii) the costs of risk evaluations specified in subparagraph (D); (C) reflect an appropriate balance in the assessment of fees between manufacturers and processors, and allow the payment of fees by consortia of manufacturers or processors; (D) notwithstanding subparagraph (B)— (i) except as provided in clause (ii), for chemical substances for which the Administrator has granted a request from a manufacturer pursuant to section 6(b)(4)(C)(ii), establish the fee at a level sufficient to defray the full costs to the Administrator of conducting the risk evaluation under section 6(b); (ii) for chemical substances for which the Administrator has granted a request from a manufacturer pursuant to section 6(b)(4)(C)(ii), and which are included in the 2014 update of the TSCA Work Plan for Chemical Assessments, establish the fee at a level sufficient to defray 50 percent of the costs to the Administrator of conducting the risk evaluation under section 6(b); and (iii) apply fees collected pursuant to clauses (i) and (ii) only to defray the costs described in those clauses; (E) prior to the establishment or amendment of any fees under paragraph (1), consult and meet with parties potentially subject to the fees or their representatives, subject to the condition that no obligation under the Federal Advisory Committee Act (5 U.S.C. App.) or subchapter II of chapter 5 of title 5, United States Code, is applicable with respect to such meetings; (F) beginning with the fiscal year that is 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and every 3 years thereafter, after consultation with parties potentially subject to the fees and their representatives pursuant to subparagraph (E), increase or decrease the fees established under paragraph (1) as necessary to adjust for inflation and to ensure that funds deposited in the Fund are sufficient to defray— (i) approximately but not more than 25 percent of the costs to the Administrator of carrying out sections 4, 5, and 6, and of collecting, processing, reviewing, and providing access to and protecting from disclosure as appropriate under section 14 information on chemical substances under this title, other than the costs to conduct and complete risk evaluations requested under section 6(b)(4)(C)(ii); and (ii) the costs of risk evaluations specified in subparagraph (D); and (G) if a notice submitted under section 5 is not reviewed or such a notice is withdrawn, refund the fee or a portion of the fee if no substantial work was performed on the notice. (5) Minimum amount of appropriations Fees may not be assessed for a fiscal year under this section unless the amount of appropriations for the Chemical Risk Review and Reduction program project of the Environmental Protection Agency for the fiscal year (excluding the amount of any fees appropriated for the fiscal year) are equal to or greater than the amount of appropriations for that program project for fiscal year 2014. (6) Termination The authority provided by this subsection shall terminate at the conclusion of the fiscal year that is 10 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act unless otherwise reauthorized or modified by Congress. ; and (3) by adding at the end the following: (h) Scientific standards In carrying out sections 4, 5, and 6, to the extent that the Administrator makes a decision based on science, the Administrator shall use scientific information, technical procedures, measures, methods, protocols, methodologies, or models, employed in a manner consistent with the best available science, and shall consider as applicable— (1) the extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information; (2) the extent to which the information is relevant for the Administrator’s use in making a decision about a chemical substance or mixture; (3) the degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented; (4) the extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and (5) the extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies, or models. (i) Weight of scientific evidence The Administrator shall make decisions under sections 4, 5, and 6 based on the weight of the scientific evidence. (j) Availability of information Subject to section 14, the Administrator shall make available to the public— (1) all notices, determinations, findings, rules, consent agreements, and orders of the Administrator under this title; (2) any information required to be provided to the Administrator under section 4; (3) a nontechnical summary of each risk evaluation conducted under section 6(b); (4) a list of the studies considered by the Administrator in carrying out each such risk evaluation, along with the results of those studies; and (5) each designation of a chemical substance under section 6(b), along with an identification of the information, analysis, and basis used to make the designations. (k) Reasonably available information In carrying out sections 4, 5, and 6, the Administrator shall take into consideration information relating to a chemical substance or mixture, including hazard and exposure information, under the conditions of use, that is reasonably available to the Administrator. (l) Policies, procedures, and guidance (1) Development Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall develop any policies, procedures, and guidance the Administrator determines are necessary to carry out the amendments to this Act made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (2) Review Not later than 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and not less frequently than once every 5 years thereafter, the Administrator shall— (A) review the adequacy of the policies, procedures, and guidance developed under paragraph (1), including with respect to animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this title; and (B) revise such policies, procedures, and guidance as the Administrator determines necessary to reflect new scientific developments or understandings. (3) Testing of Chemical Substances and Mixtures The policies, procedures, and guidance developed under paragraph (1) applicable to testing chemical substances and mixtures shall— (A) address how and when the exposure level or exposure potential of a chemical substance or mixture would factor into decisions to require new testing, subject to the condition that the Administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential; and (B) describe the manner in which the Administrator will determine that additional information is necessary to carry out this title, including information relating to potentially exposed or susceptible populations. (4) Chemical substances with completed risk assessments With respect to a chemical substance listed in the 2014 update to the TSCA Work Plan for Chemical Assessments for which the Administrator has published a completed risk assessment prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator may publish proposed and final rules under section 6(a) that are consistent with the scope of the completed risk assessment for the chemical substance and consistent with other applicable requirements of section 6. (5) Guidance Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall develop guidance to assist interested persons in developing and submitting draft risk evaluations which shall be considered by the Administrator. The guidance shall, at a minimum, address the quality of the information submitted and the process to be followed in developing draft risk evaluations for consideration by the Administrator. (m) Report to Congress (1) Initial report Not later than 6 months after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall submit to the Committees on Energy and Commerce and Appropriations of the House of Representatives and the Committees on Environment and Public Works and Appropriations of the Senate a report containing an estimation of— (A) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(i), and the resources necessary to conduct the minimum number of risk evaluations required under section 6(b)(2); (B) the capacity of the Environmental Protection Agency to conduct and publish risk evaluations under section 6(b)(4)(C)(ii), the likely demand for such risk evaluations, and the anticipated schedule for accommodating that demand; (C) the capacity of the Environmental Protection Agency to promulgate rules under section 6(a) as required based on risk evaluations conducted and published under section 6(b); and (D) the actual and anticipated efforts of the Environmental Protection Agency to increase the Agency’s capacity to conduct and publish risk evaluations under section 6(b). (2) Subsequent reports The Administrator shall update and resubmit the report described in paragraph (1) not less frequently than once every 5 years. (n) Annual plan (1) In general The Administrator shall inform the public regarding the schedule and the resources necessary for the completion of each risk evaluation as soon as practicable after initiating the risk evaluation. (2) Publication of plan At the beginning of each calendar year, the Administrator shall publish an annual plan that— (A) identifies the chemical substances for which risk evaluations are expected to be initiated or completed that year and the resources necessary for their completion; (B) describes the status of each risk evaluation that has been initiated but not yet completed; and (C) if the schedule for completion of a risk evaluation has changed, includes an updated schedule for that risk evaluation. (o) Consultation with science advisory committee on chemicals (1) Establishment Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall establish an advisory committee, to be known as the Science Advisory Committee on Chemicals (referred to in this subsection as the Committee ). (2) Purpose The purpose of the Committee shall be to provide independent advice and expert consultation, at the request of the Administrator, with respect to the scientific and technical aspects of issues relating to the implementation of this title. (3) Composition The Committee shall be composed of representatives of such science, government, labor, public health, public interest, animal protection, industry, and other groups as the Administrator determines to be advisable, including representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible subpopulations. (4) Schedule The Administrator shall convene the Committee in accordance with such schedule as the Administrator determines to be appropriate, but not less frequently than once every 2 years. (p) Prior actions (1) Rules, orders, and exemptions Nothing in the Frank R. Lautenberg Chemical Safety for the 21st Century Act eliminates, modifies, or withdraws any rule promulgated, order issued, or exemption established pursuant to this Act before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (2) Prior-initiated evaluations Nothing in this Act prevents the Administrator from initiating a risk evaluation regarding a chemical substance, or from continuing or completing such risk evaluation, prior to the effective date of the policies, procedures, and guidance required to be developed by the Administrator pursuant to the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act . (3) Actions completed prior to completion of policies, procedures, and guidance Nothing in this Act requires the Administrator to revise or withdraw a completed risk evaluation, determination, or rule under this Act solely because the action was completed prior to the development of a policy, procedure, or guidance pursuant to the amendments made by the Frank R. Lautenberg Chemical Safety for the 21st Century Act . . 18. State programs Section 28 of the Toxic Substances Control Act ( 15 U.S.C. 2627 ) is amended by striking subsections (c) and (d). 19. Conforming amendments (a) Table of contents The table of contents in section 1 of the Toxic Substances Control Act is amended— (1) by striking the item relating to section 6 and inserting the following: Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances and mixtures. ; (2) by striking the item relating to section 10 and inserting the following: Sec. 10. Research, development, collection, dissemination, and utilization of information. ; (3) by striking the item relating to section 14 and inserting the following: Sec. 14. Confidential information. ; and (4) by striking the item relating to section 25. (b) Section 2 Section 2(b)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2601(b)(1) ) is amended by striking data both places it appears and inserting information . (c) Section 3 Section 3 of the Toxic Substances Control Act ( 15 U.S.C. 2602 ) is amended— (1) in paragraph (8) (as redesignated by section 3 of this Act), by striking data and inserting information ; and (2) in paragraph (15) (as redesignated by section 3 of this Act)— (A) by striking standards and inserting protocols and methodologies ; (B) by striking test data both places it appears and inserting information ; and (C) by striking data each place it appears and inserting information . (d) Section 4 Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— (1) in subsection (b)— (A) in paragraph (1)— (i) in the paragraph heading, by adding , order, or consent agreement at the end; and (ii) by striking rule each place it appears and inserting rule, order, or consent agreement ; (B) in paragraph (2)(B), by striking rules and inserting rules, orders, and consent agreements ; (C) in paragraph (3)(A), by striking rule and inserting rule or order ; and (D) in paragraph (4)— (i) by striking rule under subsection (a) each place it appears and inserting rule, order, or consent agreement under subsection (a) ; (ii) by striking repeals the rule each place it appears and inserting repeals the rule or order or modifies the consent agreement to terminate the requirement ; and (iii) by striking repeals the application of the rule and inserting repeals or modifies the application of the rule, order, or consent agreement ; (2) in subsection (c)— (A) in paragraph (1), by striking rule and inserting rule or order ; (B) in paragraph (2)— (i) in subparagraph (A), by striking a rule under subsection (a) or for which data is being developed pursuant to such a rule and inserting a rule, order, or consent agreement under subsection (a) or for which information is being developed pursuant to such a rule, order, or consent agreement ; (ii) in subparagraph (B), by striking such rule or which is being developed pursuant to such rule and inserting such rule, order, or consent agreement or which is being developed pursuant to such rule, order, or consent agreement ; and (iii) in the matter following subparagraph (B), by striking the rule and inserting the rule or order ; (C) in paragraph (3)(B)(i), by striking rule promulgated and inserting rule, order, or consent agreement ; and (D) in paragraph (4)— (i) by striking rule promulgated each place it appears and inserting rule, order, or consent agreement ; (ii) by striking such rule each place it appears and inserting such rule, order, or consent agreement ; and (iii) in subparagraph (B), by striking the rule and inserting the rule or order ; (3) in subsection (d), by striking rule and inserting rule, order, or consent agreement ; and (4) in subsection (g), by striking rule and inserting rule, order, or consent agreement . (e) Section 5 Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— (1) in subsection (b)— (A) in paragraph (1)(A)— (i) by striking rule promulgated and inserting rule, order, or consent agreement ; and (ii) by striking such rule and inserting such rule, order, or consent agreement ; (B) in paragraph (1)(B), by striking rule promulgated and inserting rule or order ; and (C) in paragraph (2)(A)(ii), by striking rule promulgated and inserting rule, order, or consent agreement ; and (2) in subsection (d)(2)(C), by striking rule and inserting rule, order, or consent agreement . (f) Section 7 Section 7(a) of the Toxic Substances Control Act ( 15 U.S.C. 2606(a) ) is amended— (1) in paragraph (1), in the matter following subparagraph (C), by striking a rule under section 4, 5, 6, or title IV or an order under section 5 or title IV and inserting a determination under section 5 or 6, a rule under section 4, 5, or 6 or title IV, an order under section 4, 5, or 6 or title IV, or a consent agreement under section 4 ; and (2) in paragraph (2), by striking subsection 6(d)(2)(A)(i) and inserting section 6(d)(3)(A)(i) . (g) Section 8 Section 8(a) of the Toxic Substances Control Act ( 15 U.S.C. 2607(a) ) is amended— (1) in paragraph (2)(E), by striking data and inserting information ; and (2) in paragraph (3)(A)(ii)(I), by striking or an order in effect under section 5(e) and inserting , an order in effect under section 4 or 5(e), or a consent agreement under section 4 . (h) Section 9 Section 9 of the Toxic Substances Control Act ( 15 U.S.C. 2608 ) is amended— (1) in subsection (a), by striking section 6 each place it appears and inserting section 6(a) ; and (2) in subsection (d), by striking Health, Education, and Welfare and inserting Health and Human Services . (i) Section 10 Section 10 of the Toxic Substances Control Act ( 15 U.S.C. 2609 ) is amended— (1) in the section heading, by striking data and inserting information ; (2) by striking Health, Education, and Welfare each place it appears and inserting Health and Human Services ; (3) in subsection (b)— (A) in the subsection heading, by striking Data and inserting Information ; (B) by striking data and inserting information in paragraph (1); (C) by striking data and inserting information in paragraph (2)(A); and (D) by striking a data and inserting an information in paragraph (2)(B); and (4) in subsection (g), by striking data and inserting information . (j) Section 11 Section 11(b)(2) of the Toxic Substances Control Act ( 15 U.S.C. 2610(b)(2) ) is amended— (1) by striking data each place it appears and inserting information ; and (2) in subparagraph (E), by striking rule promulgated and inserting rule promulgated, order issued, or consent agreement entered into . (k) Section 12 Section 12(b)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2611(b)(1) ) is amended by striking data both places it appears and inserting information . (l) Section 15 Section 15(1) of the Toxic Substances Control Act ( 15 U.S.C. 2614(1) ) is amended by striking (A) any rule and all that follows through or (D) and inserting any requirement of this title or any rule promulgated, order issued, or consent agreement entered into under this title, or . (m) Section 19 Section 19 of the Toxic Substances Control Act ( 15 U.S.C. 2618 ) is amended— (1) in subsection (a)— (A) in paragraph (1)(A)— (i) by striking Not later than 60 days after the date of the promulgation of a rule under section 4(a), 5(a)(2), 5(b)(4), 6(a), 6(e), or 8, or under title II or IV and inserting Except as otherwise provided in this title, not later than 60 days after the date on which a rule is promulgated under this title, title II, or title IV, or the date on which an order is issued under section 4, 5(e), 5(f), or 6(i)(1), ; (ii) by striking such rule and inserting such rule or order ; and (iii) by striking such a rule and inserting such a rule or order ; (B) in paragraph (1)(B)— (i) by striking Courts and inserting Except as otherwise provided in this title, courts ; and (ii) by striking subparagraph (A) or (B) of section 6(b)(1) and inserting this title, other than an order under section 4, 5(e), 5(f), or 6(i)(1), ; and (C) in paragraph (2)— (i) by striking rulemaking record and inserting record ; and (ii) by striking based the rule and inserting based the rule or order ; (2) in subsection (b)— (A) by striking review a rule and inserting review a rule, or an order under section 4, 5(e), 5(f), or 6(i)(1), ; (B) by striking such rule and inserting such rule or order ; (C) by striking the rule and inserting the rule or order ; (D) by striking new rule each place it appears and inserting new rule or order ; and (E) by striking modified rule and inserting modified rule or order ; and (3) in subsection (c)— (A) in paragraph (1)— (i) in subparagraph (A)— (I) by striking a rule and inserting a rule or order ; and (II) by striking such rule and inserting such rule or order ; (ii) in subparagraph (B)— (I) in the matter preceding clause (i), by striking a rule and inserting a rule or order ; (II) by amending clause (i) to read as follows: (i) in the case of review of— (I) a rule under section 4(a), 5(b)(4), 6(a) (including review of the associated determination under section 6(b)(4)(A)), or 6(e), the standard for review prescribed by paragraph (2)(E) of such section 706 shall not apply and the court shall hold unlawful and set aside such rule if the court finds that the rule is not supported by substantial evidence in the rulemaking record taken as a whole; and (II) an order under section 4, 5(e), 5(f), or 6(i)(1), the standard for review prescribed by paragraph (2)(E) of such section 706 shall not apply and the court shall hold unlawful and set aside such order if the court finds that the order is not supported by substantial evidence in the record taken as a whole; and ; and (III) by striking clauses (ii) and (iii) and the matter after clause (iii) and inserting the following: (ii) the court may not review the contents and adequacy of any statement of basis and purpose required by section 553(c) of title 5, United States Code, to be incorporated in the rule or order, except as part of the record, taken as a whole. ; and (iii) by striking subparagraph (C); and (B) in paragraph (2), by striking any rule and inserting any rule or order . (n) Section 20 Section 20(a)(1) of the Toxic Substances Control Act ( 15 U.S.C. 2619(a)(1) ) is amended by striking order issued under section 5 and inserting order issued under section 4 or 5 . (o) Section 21 Section 21 of the Toxic Substances Control Act ( 15 U.S.C. 2620 ) is amended— (1) in subsection (a), by striking order under section 5(e) or (6)(b)(2) and inserting order under section 4 or 5(e) or (f) ; and (2) in subsection (b)— (A) in paragraph (1), by striking order under section 5(e), 6(b)(1)(A), or 6(b)(1)(B) and inserting order under section 4 or 5(e) or (f) ; and (B) in paragraph (4)(B)— (i) in the matter preceding clause (i), by striking order under section 5(e) or 6(b)(2) and inserting order under section 4 or 5(e) or (f) ; (ii) in clause (i), by striking order under section 5(e) and inserting order under section 4 or 5(e) ; and (iii) in clause (ii), by striking section 6 or 8 or an order under section 6(b)(2), there is a reasonable basis to conclude that the issuance of such a rule or order is necessary to protect health or the environment against an unreasonable risk of injury to health or the environment and inserting section 6(a) or 8 or an order under section 5(f), the chemical substance or mixture to be subject to such rule or order presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation, under the conditions of use . (p) Section 24 Section 24(b)(2)(B) of the Toxic Substances Control Act ( 15 U.S.C. 2623(b)(2)(B) ) is amended— (1) by inserting and at the end of clause (i); (2) by striking clause (ii); and (3) by redesignating clause (iii) as clause (ii). (q) Section 26 Section 26 of the Toxic Substances Control Act ( 15 U.S.C. 2625 ) is amended— (1) in subsection (e), by striking Health, Education, and Welfare each place it appears and inserting Health and Human Services ; and (2) in subsection (g)(1), by striking data and inserting information . (r) Section 27 Section 27(a) of the Toxic Substances Control Act ( 15 U.S.C. 2626(a) ) is amended— (1) by striking Health, Education, and Welfare and inserting Health and Human Services ; (2) by striking test data both places it appears and inserting information ; (3) by striking rules promulgated and inserting rules, orders, or consent agreements ; and (4) by striking standards and inserting protocols and methodologies . (s) Section 30 Section 30(2) of the Toxic Substances Control Act ( 15 U.S.C. 2629(2) ) is amended by striking rule and inserting rule, order, or consent agreement . 20. No retroactivity Nothing in sections 1 through 19, or the amendments made by sections 1 through 19, shall be interpreted to apply retroactively to any State, Federal, or maritime legal action filed before the date of enactment of this Act. 21. Trevor’s Law (a) Purposes The purposes of this section are— (1) to provide the appropriate Federal agencies with the authority to help conduct investigations into potential cancer clusters; (2) to ensure that Federal agencies have the authority to undertake actions to help address cancer clusters and factors that may contribute to the creation of potential cancer clusters; and (3) to enable Federal agencies to coordinate with other Federal, State, and local agencies, institutes of higher education, and the public in investigating and addressing cancer clusters. (b) Designation and investigation of potential cancer clusters Part P of title III of the Public Health Service Act ( 42 U.S.C. 280g et seq. ) is amended by adding at the end the following: 399V–6. Designation and investigation of potential cancer clusters (a) Definitions In this section: (1) Cancer cluster The term cancer cluster means the incidence of a particular cancer within a population group, a geographical area, and a period of time that is greater than expected for such group, area, and period. (2) Particular cancer The term particular cancer means one specific type of cancer or a type of cancers scientifically proven to have the same cause. (3) Population group The term population group means a group, for purposes of calculating cancer rates, defined by factors such as race, ethnicity, age, or gender. (b) Criteria for designation of potential cancer clusters (1) Development of criteria The Secretary shall develop criteria for the designation of potential cancer clusters. (2) Requirements The criteria developed under paragraph (1) shall consider, as appropriate— (A) a standard for cancer cluster identification and reporting protocols used to determine when cancer incidence is greater than would be typically observed; (B) scientific screening standards that ensure that a cluster of a particular cancer involves the same type of cancer, or types of cancers; (C) the population in which the cluster of a particular cancer occurs by factors such as race, ethnicity, age, and gender, for purposes of calculating cancer rates; (D) the boundaries of a geographic area in which a cluster of a particular cancer occurs so as not to create or obscure a potential cluster by selection of a specific area; and (E) the time period over which the number of cases of a particular cancer, or the calculation of an expected number of cases, occurs. (c) Guidelines for investigation of potential cancer clusters The Secretary, in consultation with the Council of State and Territorial Epidemiologists and representatives of State and local health departments, shall develop, publish, and periodically update guidelines for investigating potential cancer clusters. The guidelines shall— (1) recommend that investigations of cancer clusters— (A) use the criteria developed under subsection (b); (B) use the best available science; and (C) rely on a weight of the scientific evidence; (2) provide standardized methods of reviewing and categorizing data, including from health surveillance systems and reports of potential cancer clusters; and (3) provide guidance for using appropriate epidemiological and other approaches for investigations. (d) Investigation of cancer clusters (1) Secretary discretion The Secretary— (A) in consultation with representatives of the relevant State and local health departments, shall consider whether it is appropriate to conduct an investigation of a potential cancer cluster; and (B) in conducting investigations shall have the discretion to prioritize certain potential cancer clusters, based on the availability of resources. (2) Coordination In investigating potential cancer clusters, the Secretary shall coordinate with agencies within the Department of Health and Human Services and other Federal agencies, such as the Environmental Protection Agency. (3) Biomonitoring In investigating potential cancer clusters, the Secretary shall rely on all appropriate biomonitoring information collected under other Federal programs, such as the National Health and Nutrition Examination Survey. The Secretary may provide technical assistance for relevant biomonitoring studies of other Federal agencies. (e) Duties The Secretary shall— (1) ensure that appropriate staff of agencies within the Department of Health and Human Services are prepared to provide timely assistance, to the extent practicable, upon receiving a request to investigate a potential cancer cluster from a State or local health authority; (2) maintain staff expertise in epidemiology, toxicology, data analysis, environmental health and cancer surveillance, exposure assessment, pediatric health, pollution control, community outreach, health education, laboratory sampling and analysis, spatial mapping, and informatics; (3) consult with community members as investigations into potential cancer clusters are conducted, as the Secretary determines appropriate; (4) collect, store, and disseminate reports on investigations of potential cancer clusters, the possible causes of such clusters, and the actions taken to address such clusters; and (5) provide technical assistance for investigating cancer clusters to State and local health departments through existing programs, such as the Epi-Aids program of the Centers for Disease Control and Prevention and the Assessments of Chemical Exposures Program of the Agency for Toxic Substances and Disease Registry. . II Rural Healthcare Connectivity 201. Short title This title may be cited as the Rural Healthcare Connectivity Act of 2016 . 202. Telecommunications services for skilled nursing facilities (a) In general Section 254(h)(7)(B) of the Communications Act of 1934 ( 47 U.S.C. 254(h)(7)(B) ) is amended— (1) in clause (vi), by striking and at the end; (2) by redesignating clause (vii) as clause (viii); (3) by inserting after clause (vi) the following: (vii) skilled nursing facilities (as defined in section 1819(a) of the Social Security Act ( 42 U.S.C. 1395i–3(a) )); and ; and (4) in clause (viii), as redesignated, by striking clauses (i) through (vi) and inserting clauses (i) through (vii) . (b) Savings clause Nothing in subsection (a) shall be construed to affect the aggregate annual cap on Federal universal service support for health care providers under section 54.675 of title 47, Code of Federal Regulations, or any successor regulation. (c) Effective date The amendments made by subsection (a) shall apply beginning on the date that is 180 days after the date of the enactment of this Act.

Speaker of the House of Representatives. Vice President of the United States and President of the Senate.