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

Bill: 114-hr-2576
Sponsor: Rep. Shimkus, John [R-IL-15]
Introduced: 2015-05-26 in the House
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

Summary:
action_date: 2015-05-26
text: 

TSCA Modernization Act of 2015

 
 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.
 
 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.
 
 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. 
 
 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.
 
 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.
 
 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.

action_date: 2015-06-23
text: 

TSCA Modernization Act of 2015

 
 This bill amends the Toxic Substances Control Act (TSCA) to revise the process and requirements for evaluating and determining whether regulatory control of a chemical is warranted. 
 
 (Sec. 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. 
 
 (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).
 
 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.
 
 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.
 
 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.
 
 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.
 
 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).
 
 In conducting a risk evaluation, the EPA must: 
 
 
 integrate and assess information on hazards and exposures for all of the intended conditions of use of the chemical;
 
 not consider information on cost and other factors not directly related to health or the environment;
 
 take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the intended conditions of use of the chemical;
 
 describe the weight of the scientific evidence for identified hazard and exposure;
 
 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
 
 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.
 
 
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.
 
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.
 
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.
 
 The public must be given an opportunity to comment on a determination that a chemical does not and will not present an unreasonable risk. 
 
 The EPA must initiate 10 or more risk evaluations in each fiscal year.
 
 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. 
 
 The EPA must apply prohibitions and restrictions to articles containing chemicals only to the extent necessary to protect against the identified risk.
 
 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.
 
 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.
 
 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.
 
 (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.
 
 (Sec. 6) The bill revises requirements concerning the protection from disclosure of confidential business information (CBI) submitted under TSCA.
 
 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.
 
 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.
 
 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.
 
 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.
 
 (Sec. 7) The bill revises TSCA to expand federal preemption of state statues or administrative actions to manage risks from chemicals. 
 
 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.
 
 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. 
 
 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.
 
 The bill provides that nothing in TSCA shall be construed to preempt or affect either federal or state tort or contract law. 
 
 (Sec. 8) This bill revises TSCA provisions concerning accessing fees on chemical manufacturers, importers, or processors.
 
 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. 
 
 The EPA's decisions concerning testing and regulating chemicals must be based on the weight of scientific evidence. 
 
 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.

action_date: 2015-12-17
text: 

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

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

action_date: 2016-06-22
text: 

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

 
 TITLE I--CHEMICAL SAFETY
 
 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.
 
 (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. 
 
 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. 
 
 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.
 
 (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.
 
 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).
 
 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.
 
 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.
 
 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.
 
 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.
 
 (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.
 
 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.
 
 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.
 
 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.
 
 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. 
 
 The EPA may revise a low priority designation for a chemical based on information provided to the EPA about the chemical.
 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). 
 
 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.
 
 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.
 
 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. 
 
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.
 
 The scope of the risk evaluation must be published within six months after initiation. 
 
 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.
 
 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.
 
 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.
 
 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.
 
 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. 
 
 (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. 
 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. 
 
 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.
 
 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.
 
 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.
 
 (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.
 
 (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.
 
 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.
 
 (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. 
 
 The bill specifies certain CBI that is not protected, including information about banned or phased-out chemicals.
 
 The bill establishes substantiation requirements that must be met in asserting claims for CBI protection. However, certain information is not subject to substantiation requirements.
 
 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.
 
 EPA protection of disclosure of CBI is limited to 10 years, with extensions of 10 years.
 
 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.
 
 (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. 
 
 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.
 
 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.
 
 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.
 
 (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.
 
 Low priority determinations may be challenged within 60 day of publication.
 
 (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. 
 
 At the beginning of each year, the EPA must publish an annual plan and report concerning risk evaluations.
 
 (Sec. 21) The bill amends the Public Health Service Act to provide for the investigation of potential cancer clusters.
 
 Title II -- RURAL HEALTHCARE CONNECTIVITY
 
 
Rural Healthcare Connectivity Act of 2016 

 
 (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.


Legislative actions:
action_date: 2016-06-22
text: Became Public Law No: 114-182.
action_date: 2016-06-22
text: Became Public Law No: 114-182.
action_date: 2016-06-22
text: Signed by President.
action_date: 2016-06-22
text: Signed by President.
action_date: 2016-06-14
text: Presented to President.
action_date: 2016-06-14
text: Presented to President.
action_date: 2016-06-07
text: Message on Senate action sent to the House.
action_date: 2016-06-07
text: Senate agreed to the House amendment to the Senate amendment by Voice Vote. (consideration: CR S3523)
action_date: 2016-06-07
text: Resolving differences -- Senate actions: Senate agreed to the House amendment to the Senate amendment by Voice Vote.(consideration: CR S3523)
action_date: 2016-06-07
text: Measure laid before Senate by unanimous consent. (consideration: CR S3511-3525)
action_date: 2016-05-24
text: Message on House action received in Senate and at desk: House amendment to Senate amendment.
action_date: 2016-05-24
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2016-05-24
text: On motion that the House agree with an amendment to the Senate amendment Agreed to by the Yeas and Nays: 403 - 12 (Roll no. 238). (text as House agreed with an amendment to the Senate amendment: CR H3007-3025)
action_date: 2016-05-24
text: Resolving differences -- House actions: On motion that the House agree with an amendment to the Senate amendment Agreed to by the Yeas and Nays: 403 - 12 (Roll no. 238).(text as House agreed with an amendment to the Senate amendment: CR H3007-3025)
action_date: 2016-05-24
text: Considered as unfinished business. (consideration: CR H3046-3047)
action_date: 2016-05-24
text: POSTPONED PROCEEDINGS - At the conclusion of debate on the motion to concur in the Senate amendment with an amendment, the Chair put the question on adoption of the motion and by voice vote announced that the ayes had prevailed. Mr. Pallone demanded the yeas and nays and the Chair postponed further proceedings on the question of adoption of the motion until a time to be announced.
action_date: 2016-05-24
text: The previous question was ordered pursuant to the rule. (consideration: CR H3031)
action_date: 2016-05-24
text: DEBATE - The House proceeded with one hour of debate on the motion to concur in the Senate amendment with an amendment.
action_date: 2016-05-24
text: Mr. Shimkus moved that the House concur in the Senate amendment with an amendment. (consideration: CR H2989-3031; text: CR H2989-3007)
action_date: 2016-05-24
text: MOTION OFFERED - Pursuant to the provisions of H. Res. 742, the Chair recognized Mr. Shimkus for a motion.
action_date: 2016-05-24
text: ORDER OF PROCEDURE - Mr. Shimkus asked unanimous consent that the question of adopting a motion to concur in the Senate amendment to H.R. 2576 with an amendment may be subject to postponement as though under clause 8 of rule XX. Agreed to without objection.
action_date: 2016-05-24
text: Rule H. Res. 742 passed House.
action_date: 2016-05-23
text: Rules Committee Resolution H. Res. 742 Reported to House. Resolution provides for consideration of H.R. 897 and the Senate amendment to H.R. 2576.
action_date: 2015-12-18
text: Message on Senate action sent to the House.
action_date: 2015-12-17
text: Passed Senate with an amendment by Voice Vote.
action_date: 2015-12-17
text: Passed/agreed to in Senate: Passed Senate with an amendment by Voice Vote.
action_date: 2015-12-17
text: Measure laid before Senate by unanimous consent. (consideration: CR S8781-8782)
action_date: 2015-07-08
text: Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 143.
action_date: 2015-06-24
text: Received in the Senate.
action_date: 2015-06-23
text: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 398 - 1 (Roll no. 378). (text: CR H4551-4556)
action_date: 2015-06-23
text: Motion to reconsider laid on the table Agreed to without objection.
action_date: 2015-06-23
text: Passed/agreed to in House: On motion to suspend the rules and pass the bill, as amended Agreed to by the Yeas and Nays: (2/3 required): 398 - 1 (Roll no. 378).(text: CR H4551-4556)
action_date: 2015-06-23
text: Considered as unfinished business. (consideration: CR H4581-4582)
action_date: 2015-06-23
text: At the conclusion of debate, the Yeas and Nays were demanded and ordered. Pursuant to the provisions of clause 8, rule XX, the Chair announced that further proceedings on the motion would be postponed.
action_date: 2015-06-23
text: DEBATE - The House proceeded with forty minutes of debate on H.R. 2576.
action_date: 2015-06-23
text: Considered under suspension of the rules. (consideration: CR H4551-4560)
action_date: 2015-06-23
text: Mr. Shimkus moved to suspend the rules and pass the bill, as amended.
action_date: 2015-06-23
text: Placed on the Union Calendar, Calendar No. 131.
action_date: 2015-06-23
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-176.
action_date: 2015-06-23
text: Reported (Amended) by the Committee on Energy and Commerce. H. Rept. 114-176.
action_date: 2015-06-03
text: Ordered to be Reported (Amended) by the Yeas and Nays: 47 - 0.
action_date: 2015-06-03
text: Committee Consideration and Mark-up Session Held.
action_date: 2015-06-02
text: Committee Consideration and Mark-up Session Held.
action_date: 2015-06-02
text: Committee Hearings Held.
action_date: 2015-05-26
text: Referred to the House Committee on Energy and Commerce.
action_date: 2015-05-26
text: Introduced in House
action_date: 2015-05-26
text: Introduced in House

Enacted as: number: 114-182