This analysis reviews the changes made to the original version of the Chemical Safety Improvement Act (CSIA) (identified as CSIA1 in this memorandum) based on Senator Barbara Boxer's (D-CA) version of the Toxic Substances Control Act (TSCA) reform legislation released on September 18, 2014 (Boxer TSCA). This analysis attempts to analyze both the interim changes made to the bill and the changes that appear as underlined text in Boxer TSCA.
Boxer TSCA was reportedly created by Senator Boxer by a process that involved accepting interim changes that had been made to CSIA1 reportedly by a bipartisan group of Senators headed by Senators Tom Udall (D-NM) and David Vitter (R-LA). This draft interim version of the bill, which is identified in this analysis as 'U-V CSIA,' has never been publicly released. The process that was used to create this interim version of U-V CSIA involved comparing the original CSIA1 and Boxer TSCA versions after having (for purposes of this process) deleted all of the additions that appeared in Boxer TSCA. The result of this comparison should closely approximate the U-V CSIA proposal with additions underlined and deleted text lined out, although the U-V CSIA version produced by this process is likely not a 'final' version of that proposal given its July date. If you would like a copy of this 'recreated' document, please contact Chad Howlin.
In general, U-V CSIA represents important and significant change from the original CSIA. U-V CSIA is much improved -- clearer, more focused, and streamlined. Key issues that may invite controversy include: revision of 'intended conditions of use' to include the new concept of 'or reasonably anticipated,' that considerably broadens the meaning; the wide breadth of the U.S. Environmental Protection Agency (EPA) determination of relevancy of subpopulations in the definition of safety standard; exceedingly aggressive implementation schedule (and no obvious means of resourcing it); sources of information seems broad and perhaps too inclusive and lacking a reliability measure (for example, advanced testing without screening); changes reducing confidential business information (CBI) protection for CBI (especially regarding chemical identity) that may go too far; preemption, although it has been narrowed, still needs work; and the standard of judicial review remains substantial evidence.
Boxer TSCA, on the other hand, apparently accepted the overwhelming majority of the changes made in U-V CSIA, but beyond this makes changes that have been advocated by environmentalists, including, as noted in Senator Boxer's press statement, available online, increased attention given to vulnerable populations, tighter deadlines, greater protection of state preemption, fees provisions, and other provisions.
Summary and Analysis
Section 2 Findings, Policy, Intent
- The section was shortened and simplified from that in CSIA1 and proposes to modify TSCA Section 2(a) Findings by inserting several new provisions while retaining TSCA Sections 2(b) Policy and 2(c) Intent of Congress without change. In retaining these sections, the text has lost specific references to 'economic barriers,' 'encouraging innovation,' and 'safer chemistry' that appeared in these sections in CSIA1. The TSCA language that authority should be exercised 'in such a manner as not to impede unduly or create unnecessary economic barriers to technological innovation' is retained.
- U-V CSIA Section 2(a)(3)-(5) proposes new subsections, including:
- Specific reference to protecting the health of several vulnerable subpopulations, including children, pregnant women, the elderly, workers, etc. from the 'risks of harmful exposures.' Importantly, in making this change, the provision does not include the concept of 'safe for intended use' that had appeared in CSIA1.
- A statement that the law does not affect common law rights of action or civil relief remedies.
- Clarification of the treatment of CBI by indicating that 'appropriate information ... should be available to public health officials and first responders in the event of an emergency.'
- Seemingly accepted U-V CSIA without change.
Section 3 Definitions
U-V CSIA deletes the definition of 'best available science' that had appeared in CSIA1, proposes several new definitions, amends the CSIA1 language in other definitions, and proposes a new Section 3A on Policies, Procedures, and Guidance.
The new definitions include:
- (7) Information. The proposed definition, although broad, does not address weighting, and the notion in CSIA1 that some information should be weighted more than other information has been lost.
- (12) Potentially exposed or susceptible population as defined means a group or groups of individuals who 'may be differentially exposed to chemical substances under the intended or reasonably anticipated conditions of use and/or who may be susceptible to greater adverse health consequences' from chemical exposures than the general population. The definition seems to suggest that such populations are to be identified by EPA and may include such groups as 'infants, children, pregnant women, workers, and the elderly.'
- (14) Publicly available information, defined as generally accessible and available to the general public.
The revised definitions include:
- (8) Intended or reasonably anticipated conditions of use, as revised, includes the concept of 'reasonably anticipated' in addition to 'intended' conditions of use and is stated to be based on an EPA determination of the conditions of use that are 'intended, reasonably known, or reasonably anticipated.' The inclusion of 'reasonably anticipated' conditions of use changes the dynamics of the legislation considerably. What is intended as a use and what users may do with the product are different things, but plainly expands the scope of the provision and places a burden on industry to 'reasonably anticipate' uses if only to ensure that EPA's determination is well informed.
- (15) Safety assessment, as revised, includes the concept of 'intended or reasonably anticipated conditions of use,' involves integration of hazard, use, and exposure information, and has deleted the CSIA1 provision concerning 'reference parameters...such as a margin of exposure.'
- (17) Safety standard, as revised, explicitly precludes consideration of cost or other non-risk factors in applying the safety standard although it retains the TSCA legacy terminology of 'unreasonable risk.' The provision retains the CSIA1 language that 'no unreasonable risk of harm will result' from exposure but clarifies that this relates to 'intended or reasonably anticipated conditions of use' and further states that this includes exposure to the 'general population or any potentially exposed or susceptible subpopulations that' EPA has identified as relevant.
Boxer TSCA accepts many of the changes in U-V CSIA, but proposes additional changes, including the following:
- Term (8) is modified to read Intended or reasonably anticipated foreseeable conditions of use.
- The definition no longer involves an EPA determination; and
- It adds the concept of releases to the environment, including 'reasonably foreseeable but unintended exposure conditions from unplanned releases.'
The replacement of 'anticipated' by 'foreseeable' is carried throughout the text wherever it appeared in U-V CSIA.
- Term (12) Potentially exposed or susceptible population is modified to include the concepts of 'reasonably anticipated foreseeable conditions of use and/or who may be more susceptible to greater adverse health consequences.'
- Term (17) Safety Standard is revised to involve the concept of 'reasonable certainty' and also deletes 'no unreasonable risk of harm' and replaces it with 'no harm.'
Section 3A Policies, Procedures, and Guidance
The new Section 3A consolidates 'policies, procedures, and guidance' provisions scattered in CSIA1. The consolidated language in U-V CSIA seems relatively consistent with CSIA1, but warrants closer review. It also includes a new concept requiring formation of a Science Advisory Committee on Chemicals. Boxer TSCA accepts some of the changes but deletes others (including a provision regarding 'weight of the scientific evidence') and adds specificity to a provision regarding reports by the National Academy of Sciences (NAS).
- Concerning the consolidated provisions, we draw your attention to the following: Two-year deadline for development of all policies, procedures, and guidance 'needed to carry out sections 4, 4A, 5, and 6.' The deadline strikes us as exceedingly tight given the scope and complexity of the issues as well as the time needed for review by the Office of Management and Budget (OMB). This last point applies to all of the deadlines in U-V CSIA as well as Boxer TSCA.
- EPA is to establish policies, procedures, and guidance for its use of science. This is to be developed 'consistent with the best available science' taking into account, among others, the extent to which the information has been subject to peer review, and requires an opportunity for public review and comment.
- EPA is to rely on peer reviewed information in establishing policies, procedures, and guidance.
- Re-review of policies, procedures, and guidance is required within five years and every five years thereafter, presumably with the goal of keeping current with latest science developments. While useful, this imposes a heavy burden on EPA and may be more frequent than necessary and the process may benefit from greater flexibility as far as timing is concerned. The range of sources of information also appears quite generous.
- Regarding the schedule for completion of safety assessments and determinations, EPA is required to inform the public 'as soon as possible,' of a timeline that lacks specificity.
- In developing policies and procedures for safety assessments and determinations, EPA is required to describe how aggregate exposures will be considered in those steps and is required to explain the basis for their consideration in the final safety assessment.
EPA is required to establish a 'Science Advisory Committee on Chemicals,' subject to the Federal Advisory Committee Act (FACA), to provide independent advice regarding scientific and technical aspects. This addition seems to be a good idea, as it reflects diverse interests, and should also prove helpful in assisting and strengthening EPA's efforts, much as the Federal Insecticide, Fungicide, and Rodenticide Act's (FIFRA) Scientific Advisory Panel (SAP) has done for that program.
- Whereas CSIA1 had specified that 'any' policies, procedures, and guidance needed to carry out Sections 4, 4A, 5, and 6 be subjected to public comment, Boxer TSCA limits this to the guidance, etc. required by Section 3A.
- As noted above, deletes a provision regarding the role of 'weight of the scientific evidence.'
- Directs EPA to 'follow the applicable recommendations' in specifically identified NAS reports. This strikes us as having an effect of 'locking in' those recommendations regardless of future changes in the scientific understanding.
- Regarding Section 4A(f) concerning testing, Boxer TSCA explicitly states that 'lack of information on exposure or exposure potential shall not, by itself, be a reason not to require testing.'
- It also explicitly gives EPA authority to require additional higher tier testing for purposes of prioritization; U-V CSIA had limited such testing to that needed for safety assessments and determinations.
- Subsection (g) requires that EPA:
- '[I]dentify all potentially exposed or susceptible populations that' EPA determines are pertinent to the chemical;
- Determine the nature and extent of exposures for 'each potentially exposed or susceptible population, included aggregate exposures...'; and
- In characterizing the nature and extent of the risk, take aggregate exposures into account.
Boxer TSCA thus envisions a substantially greater role for aggregate exposures in assessing and managing risks. Also, the effect of 'all' and 'each' in the provisions quoted above requires closer examination to understand their full effect.
- Subsection (i) imposes a 120-day deadline for EPA to 'issue a public response to the principal recommendations' in any NAS report concerning chemical hazard, exposures, or risks.
Section 4 Testing
U-V CSIA retains the approach in CSIA1 of deleting TSCA Sections 4(a)-(d), re-designating Section 4(e) (regarding the Interagency Testing Committee) as Section 4(g), and slightly revising TSCA Section 4(f). It does, however, introduce a new Section 4A Prioritization Screening.
TSCA Section 4(a) is retitled by deleting 'test data' and substituting the considerably broader term 'information.' As revised, this section would allow EPA to require development of 'needed' new information to support actions under Sections 5, 6, and 12(a)(4) (to test chemicals 'manufactured for export only'), or to support the regulatory testing needs of another federal agency. U-V CSIA Section 4(a)(2) provides somewhat greater but still limited authority to require development of new information 'needed to establish the priority' of a chemical under Section 4A, although this cannot take the form of 'establishing or implementing minimum information requirements.'
U-V CSIA Section 4(b) continues to require development by EPA of a statement of need for requiring development of new information, although with some revisions, including the following:
- Section 4(b)(1)(C) has been revised such that it no longer specifies that EPA 'encourage...the use of nonanimal test methods,' rather it requires that EPA 'explain the basis' for any vertebrate animal testing.
- U-V CSIA requires that EPA provide additional explanation (justification) when it uses order authority under this section, although EPA would no longer be required to discuss its use of Structure Activity Relationships (SAR) approaches as part of this.
U-V CSIA Sections 4(c)-(e) (which include reduction of vertebrate animal testing, testing requirements, and transparency) generally follow the approach in CSIA1.
Boxer TSCA accepts many of the changes in U-V CSIA but differs in several important provisions, including the following:
- Whereas U-V CSIA at Section 4(a)(2) had discussed the concept of 'limited testing' for prioritization purposes, Boxer TSCA deletes 'limited.'
- While U-V CSIA had discussed the concept of 'vertebrate' or 'non-animal' testing in the context of animal welfare provisions, Boxer TSCA limits this to mammalian testing.
- It also deletes the subsection concerning '[c]riteria for adapting or waiving animal testing requirements.'
Section 4A Prioritization Screening
The new Section 4A is based on CSIA1 Section 4(e) and, while the approaches differ in significant ways between the two new versions, they also include a number of important revisions from CSIA1.
Changes include the following:
- Consistent with CSIA1, requires EPA to establish within one year a risk-based screening process and criteria. U-V CSIA also, however, specifies that this be done by rule.
- CSIA strengthens and sharpens the requirements for EPA to develop an initial list of high priority substances by specifying a six-month deadline for this initial list and that it include 'at least 10' chemicals.
- While CSIA1 had used the term 'high exposure' in the context of this section, U-V CSIA replaces this with the term 'widespread exposure' such that the new formulation for high priority determinations involves 'high hazard' and/or (depending on the subsection) 'widespread exposure.'
- U-V CSIA has somewhat increased EPA discretion to consider 'inactive substances' in the prioritization process by replacing CSIA1's 'shall only consider' language with the statement that EPA 'may consider inactive substances.' U-V CSIA also allows EPA to consider inactive chemicals that have been subject to prior action to 'ban or phase out' if there is 'potential for residual high hazards or widespread exposures not otherwise addressed' by the action taken. This last provision might be intended to deal with a chemical such as Methyl tertiary-butyl ether (MTBE), for example.
- U-V CSIA includes a new Subsection 4A(a)(3)(A)(iii) on 'Repopulation' of the high priority list. Whereas CSIA1 had required only that chemicals be removed from the high priority list when completed, CSIA specifies that, in addition, at least one chemical be added to the list until safety assessments and determinations have been 'completed on all high priority' chemicals (this latter language helps to reinforce the requirement that otherwise appears in Section 6(a)).
- Regarding 'timely completion' of the prioritization screening process, whereas CSIA1 Section4(e)(1)(C) had required that EPA 'shall make every effort to complete prioritization of all active substances,' U-V CSIA Section 4A(a)(3)(B) specifies several deadlines, including that:
- EPA shall begin the prioritization screening process six months after completing the final rule (noted above) on the risk-based screening process and shall then make every effort to complete the screening in a timely manner.
- EPA shall, within 90 days after receipt of information required by rule, order, or consent agreement under Section 4(a)(2), designate the chemical as high or low priority. This seems to be a very tight deadline for EPA to meet depending on the scope and complexity of the required information.
- EPA 'shall publish' an annual goal for the number of substances to be screened.
- Whereas CSIA1 had required EPA 'from time to time' to publish lists of chemicals being considered in the screening process, U-V CSIA specifies that this be done 'not less frequently than annually.'
- U-V CSIA includes a new Subsection 4A(b)(9) Review that reiterates a point made in U-V CSIA Section 3A that EPA shall review and if necessary modify the screening prioritization process 'every 5 years' after the date of establishment of the process.
- U-V CSIA Section 4A(b) Prioritization Screening Process and Decisions includes more specificity as to what EPA shall include in the rule under U-V CSIA Section 4(a). Among these is the provision at Subsection (4) concerning 'Identification of low priority substances' where CSIA1's 'likely to meet the safety standard' language has been strengthened by requiring that EPA have 'information sufficient to establish [that the chemical] is likely to meet the safety standard.'
- The approach in U-V CSIA Section 4A(b)(4) Criteria is generally consistent with that in CSIA1 except in Subsection (G) which allows limited availability of information to serve as the basis for a high priority designation. This provision has been clarified, however, to state that 'such limited availability shall not require designation as a high priority.'
- U-V CSIA Section 4A(b)(8) Revision Based on New Information gives EPA greater discretion than that provided in CSIA1. CSIA1 had specified that such revision be done 'at any time' while U-V CSIA has added that this is explicitly 'at the Administrator's discretion.'
- Consistent with CSIA1, U-V CSIA allows a governor/state agency to petition EPA to make priority decisions and EPA has 180 days to decide. U-V CSIA, however, limits such recommendations to two years from a governor/state agency although it further specifies at Section 4A(c)(3) that such recommendation concerning a chemical that has been previously prioritized 'need not be based on new information.'
- Regarding final agency actions, U-V CSIA Section 4A(d) states that 'except as provided in Section 18(e)(6)(B),' prioritization decisions are not considered final agency actions or subject to judicial review. The cross-referenced Subsection, however, does not appear in the Boxer TSCA text.
- Submission of information must be done over a 'reasonable duration.' It is unclear what this means.
- Requires that EPA identify at least 15 (versus ten in U-V CSIA) chemicals in the initial list for high priority chemicals.
- Requires that EPA on an annual basis add at least 15 additional chemicals to the priority list.
- Whereas U-V CSIA had required that EPA add one new chemical to the priority list for each one removed, Boxer TSCA, subject to a new fees provision at Section 21, would require that EPA add three chemicals for each one removed.
- Boxer TSCA makes a number of important changes to Section 4A(a)(6) concerning the criteria for prioritization:
- Whereas U-V CSIA had included a provision regarding priority recommendations from a state governor or a state agency, Boxer TSCA significantly broadens the concept of recommendations by including recommendations by the public. How such public recommendations might be made, etc. is seemingly not further discussed in the bill.
- Whereas U-V CSIA had included the concept of 'the hazard and exposure potential' of the chemical among the criteria, Boxer TSCA limits this to hazard alone.
- Boxer TSCA deletes a criterion concerning the extent of federal or state regulation.
- Boxer TSCA adds a new criterion regarding the potential threat a chemical poses to drinking water supplies, including whether the chemical is 'stored near sources of drinking water.' The provision is obviously directed in part at the recent spill in West Virginia. At the same time, an understanding of the full effect of the change requires additional consideration.
- Regarding Section 4A(b), Boxer TSCA makes important changes to the prioritization screening process:
- Regarding identification of such priorities, whereas U-V CSIA had discussed a chemical that 'has the potential for high hazard and widespread exposure,' Boxer TSCA would change this to 'has, or has the potential for significant hazard and significant or substantial exposure.' The concept of 'significant or substantial exposure,' while new to the CSIA legislative developments process, is familiar from its use in TSCA Sections 4 and 5.
- Regarding identification of low priority substances, whereas U-V CSIA had focused this on chemicals that have 'information sufficient to establish that it is likely to meet the safety standard,' Boxer TSCA would also require that the information be sufficient for an 'informed evaluation' of the risks and that EPA identify the information and describe the analysis on which the determination is based.
- Boxer TSCA deletes Subsection (c) Expedited Prioritization Screening that had appeared in U-V CSIA.
- In an important change, Boxer TSCA makes a low priority designation a final agency action subject to judicial review.
Section 5 New Chemicals
The approach under U-V CSIA is generally similar to that in CSIA1 wherein EPA is required to make a determination whether a new chemical or significant new use is or is not likely to meet the safety standard, or that additional information is needed. Boxer TSCA accepts the U-V CSIA approach although it adds 'mixture or articles' references to several provisions that had spoken to 'chemical substances' alone.
Among the changes are the following:
- U-V CSIA has a new requirement at Section 5(c)(4)(B) that EPA, within 90 days of implementing a consent agreement or order, must proceed to either implement a Significant New Use Rule (SNUR) or publish a statement of reasons why such action is not needed. Whereas TSCA Section 5(g) had applied this concept to EPA's review of Significant New Use Notifications (SNUN), the effect of this provision seems likely to increase the number of regulated new chemicals that are made subject to a SNUR, as it may be easier to take a SNUR action than it would be to explain why the action is not needed.
- A new provision at U-V CSIA Section 5(c)(4)(D) requires EPA to 'consult' with the Occupational Safety and Health Administration (OSHA) prior to 'adopting any prohibitions or restrictions' affecting workplace exposures. This type of provision also appears in several other places (including Section 6) and, while it is difficult to argue against the concept of such consultation with the federal agency having the general responsibility for workplace issues, the provision could have the effect of limiting EPA action on workplace issues due to the new OSHA consultation requirement.
- Wording on SNUR for testing is to 'address potential risk' and not to refine information for assessment.
- U-V CSIA retains the TSCA Section 5(h)(4) exemptions although it changes the regulatory standard from CSIA1's 'is expected to meet' to U-V CSIA's 'will meet the safety standard.'
- Finally, U-V CSIA includes at Section 5(i) a savings clause regarding prior actions taken under Section 5 of TSCA.
Section 6 Existing Chemicals
U-V CSIA almost totally reworked the approach to Section 6 that had appeared in the original CSIA1. In many ways the scope and the specifics of the changes are surprising in how far they lean in the direction of responding to environmental group criticisms of the original approach; there are additional changes that seem to improve the process and procedural aspects. Among the important shifts are the following: specification in the text of seemingly ambitious deadlines for decisions and actions; an explicit ability for EPA to utilize already existing assessments; a requirement that EPA merely 'consider' cost and benefit information in taking regulatory actions; and a more workable and useful exemptions process and procedure.
Boxer TSCA, while accepting many of the changes in U-V CSIA, proposes significant modifications to the specifics of the U-V CSIA approach while adding entirely new sections relating to Persistent, Bioaccumulative, and Toxic (PBT) chemicals and regulation of all forms of asbestos.
- U-V CSIA Section 6(a) explicitly requires that EPA:
- Shall conduct a safety assessment and make a safety determination on each high priority chemical;
- Shall complete both the safety assessment and determination within three years after making the high priority designation, and
- Shall promulgate a final rule pursuant to Section 6(d) within two years after completing the safety determination, although
- EPA can extend these deadline timeframes for up to two years in the aggregate.
- U-V CSIA Section 6(b) includes two 'savings clause'-type provisions regarding 'already initiated assessments' and 'actions completed' prior to completion of the policy or procedure established under U-V CSIA Sections 3A or 4A. One question is the effect of the 'already initiated assessments' provision with regard to the TSCA Work Plan chemicals, which by EPA's admission do not involve full-blown risk assessments but focused risk assessments on EPA-selected specific uses. It remains to be seen whether such targeted assessments, despite the attempt at a savings clause, can be read to satisfy U-V CSIA requirements, including meeting the Section 3 definitions of 'safety assessment' and 'safety determination' and the provisions in U-V CSIA Sections 6(a)-(c).
- U-V CSIA Section 6(c) continues but somewhat modifies the approach in CSIA1 regarding safety determinations.
- EPA continues to be required to determine whether the chemical 'meets' or 'does not meet' the safety standard, or that additional information is required.
- But whereas CSIA1 had merely required that EPA 'shall impose additional restrictions' (emphasis added) when it determines that a chemical does not meet the safety standard, U-V CSIA expands and clarifies this point by requiring that EPA 'shall by rule under subsection (d) impose restrictions necessary to assure that the substance meets the safety standard under the intended or reasonably anticipated conditions of use, or, where the safety standard cannot be met with the application of restrictions, to ban or phase out the substance.'
- U-V CSIA Section 6(c)(2) also expands and clarifies the steps taken when additional information is determined to be needed. Specifically the text reinforces the Section 6(a) deadlines and seemingly starts the clock moving again once EPA 'finds' that the new information 'supports' the assessment and determination; how this finding is to be made or be communicated is not discussed. It also requires that EPA 'shall establish a deadline' for submission of the needed information and that the deadline 'shall be of reasonable duration' (which reiterates the similar provision in Section 4).
- A new provision under U-V CSIA Section 6(c)(1) allows and seemingly requires that EPA consider 'draft safety assessments submitted by interested persons' in making safety determinations.
- In taking control actions under U-V CSIA Section 6(d)(1), EPA is to 'promulgate a rule establishing restrictions necessary to ensure that the chemical substance meets the safety standard.'
- In taking such actions, EPA is required per U-V CSIA Section 6(d)(2) to include mandatory compliance dates that 'shall be as soon as feasible and may vary for different affected persons' based on EPA's determination. In an important provision for article manufacturers, EPA is also given authority to 'exempt replacement parts for articles manufactured prior to the applicable compliance deadline.' EPA is also required to consult with OSHA prior to adopting any actions to address workplace exposures.
- U-V CSIA Section 6(d)(4) Analysis for Rulemaking requires that EPA '[w]hen deciding which restrictions to impose... shall consider, to the extent practicable based on reasonably available information, the quantifiable and non-quantifiable costs and benefits of the proposed regulatory action and of the primary alternative regulatory action or actions considered by' EPA. Further, 'as part of the analysis' EPA is required to review technically and economically feasible alternatives that EPA 'determines are relevant to the rulemaking.' The analysis is to be made publicly available as part of the rule proposal and in issuing the rule in final, EPA 'shall include a statement describing how the analysis...was taken into account.' U-V CSIA has thus considerably softened the cost-benefit requirements that would apply to regulatory actions compared to those that had appeared in TSCA Section 6 (including 'least burdensome') and in the original CSIA1.
- U-V CSIA substantially revises and expands Section 6(d)(5) Exemptions by somewhat rewording the exemption provisions and including a number of new process and procedural provisions.
- EPA may exempt the use of a chemical if EPA 'determines that the rule cannot be complied with, without...harming national security;... causing significant disruption in the national economy due to the lack of availability of a chemical substance;... interfering with a critical or essential use for which to [sic; seemingly 'no' is intended] technically and economically feasible safer alternative is available, considering hazard and exposure; or...may exempt the use...if such use, as compared to reasonably available alternatives, provides a substantial ['net' in CSIA1] benefit to human health, the environment, or public safety' (emphasis added).
- EPA is required to make available as part of the proposal any analysis conducted under this Section and to include a statement in the final rule describing how the analysis was taken into account. For ban or phase-out restriction actions, EPA is required to conduct an analysis of the alternative(s) 'most likely to be used.'
- Regarding the time limit for exemptions, EPA is required to set a reasonable 'case-by case' limit to the duration of which can be extended when warranted. Issuance of exemptions is to be based on factors determined to be 'relevant to the goals of fostering innovation and the development of alternatives,' provided that any renewal of an exemption for a ban/phase-out chemical shall not exceed five years.
- Section 6(d)(2) is confusing. As stated, it seems to state that risk management may (i) apply to mixtures and (ii) exempt replacement parts for articles manufactured before commencement of the applicable compliance deadline.
- Finally, per U-V CSIA Section 6(f), all safety determinations and associated safety assessments are considered final agency action although U-V CSIA removed the notation that such actions were also subject to judicial review.
As noted above, while there are a number of important changes, we draw attention to the following:
- Regarding restriction actions, Section 6(d)(3) includes specific references to 'mixture or article containing the substance' whereas U-V CSIA had limited the provisions to 'chemical substances.'
- Whereas U-V CSIA had required EPA to analyze the costs and benefits in taking any Section 6 actions, Boxer TSCA would limit this to rules having an 'annual effect on the economy of $100 million or more.' It is our view, given that many of the actions that might be taken to manage chemical risks would fall far below this trigger level, the effect of the change is to remove effectively cost/benefit considerations from Section 6 regulations.
- Regarding the exemption provisions at Section 6(d)(5), Boxer TSCA would accept several of the U-V CSIA exemptions as worded but would delete the U-V CSIA provision allowing exemptions based on an EPA determination that the target chemical 'provides a substantial benefit' in comparison to reasonably available alternatives and seemingly replace it with a new exemption regarding a 'particular use' that is strictly risk-based.
- Whereas U-V CSIA had required an additional analysis in the case of a ban or phase-out, Boxer TSCA deletes this provision.
- Regarding the duration of exemptions, U-V CSIA had allowed EPA to determine what was 'reasonable on a case-by-case basis,' in contrast Boxer TSCA explicitly limits exemptions to five years.
- Boxer TSCA includes new provisions at Section 6(f) regarding PBTs and 6(j) regarding asbestos:
- EPA is required to publish a list of PBTs within 180 days and undertake expedited data collection, risk assessment, and exposure reduction actions to achieve the 'maximum practicable reduction' in exposure to such PBTs.
- There is a separate Subsection 6(g) regarding a report to Congress on exposures to PBTs in public buildings.
- For 'all forms of asbestos,' EPA is required to include them on the high priority list, complete a safety assessment and determination within two years, and promulgate a final rule one year thereafter.
Section 8 Information Gathering
U-V CSIA generally follows the approach in CSIA1 to this section with important modifications, particularly with regard to CBI. Boxer TSCA accepts much of what appears in this section of U-V CSIA but makes additional changes to the CBI provisions. Also, in an important change regarding the timing of the notification for changing a chemical's status from inactive to active, proposes to require the notification 'at least 90 days before' the chemical is manufactured or processed (U-V CSIA had merely required notification 'before the date' of manufacture or processing).
- Section 8(a)(4) specifies that reporting rules to obtain information needed 'to carry out sections 4 and 6' must be promulgated within two years. Reporting by processors is required to be included in the rule.
- Whereas CSIA1 had specified that the reporting 'be limited to active substances' and that it 'shall apply only to the extent...necessary,' U-V CSIA states that reporting 'shall apply only where [EPA] determines...reports would assist' in effectively implementing the Act.
- EPA is required to limit the potential for duplicative reporting, minimize the impact on small manufacturers and processors, and apply the reporting obligation to the persons likely to have relevant information.
- U-V CSIA retains the nomenclature provisions (regarding certain Class 2 chemicals and statutory mixtures) that appeared in CSIA1.
- U-V CSIA also retains an 'Inventory reset' component with a requirement that EPA promulgate within one year a reporting rule for identifying 'active' chemicals; the rule would be applicable to chemicals manufactured or processed over the past ten years (up from five years in CSIA1). The information received would be used to designate and list chemicals as 'active.' U-V CSIA has deleted and seemingly does not require that EPA 'designate' inactive chemicals although the text is confusing in this regard in at least one spot.
- As part of this reporting, existing CBI claims for chemical identification would need to be reaffirmed and substantiated.
- One year after compiling the list of active chemicals, EPA would be required to establish by rule a plan to, within five years (with a two-year extension being possible), review all such claims, including any such substantiation of CBI claims for chemical identity made by companies over the past five years, and to 'approve, modify, or deny such claim.' Any such approvals are limited to ten years.
- U-V CSIA also states that the plan shall 'encourage' manufacturers and processors that made CBI claims on chemical identity of inactive chemicals to review and withdraw or substantiate such claims. Any inactive chemical that does not have a CBI claim for chemical identity and for which a company wishes to change its status to 'active' shall not be eligible for CBI protection.
- Boxer TSCA accepts without change the nomenclature provisions and the ten-year window for the reporting to identify 'active' chemicals.
- Whereas U-V CSIA had required EPA to use rulemaking to establish its plan for reviewing CBI claims for chemical identity, Boxer TSCA merely requires that EPA 'develop' such a plan.
- As noted above, Boxer TSCA would require 90-day advance notification for resumption of manufacture or process of an inactive chemical, thus making the timing identical to that required for a Premanufacture Notice (PMN). The version does not impose any additional requirements in making the notification, although perhaps the intent is to give EPA some time to respond if needed (e.g., adding it to the priority list) before commercialization has recommenced.
Section 12 Exports
U-V CSIA makes a number of changes to CSIA1 as discussed below and Boxer TSCA accepts those changes without revision.
- U-V CSIA adds a new Section 12(a)(4) Testing that gives EPA authority to issue Section 4 testing requirements for chemicals that are manufactured for export only for the purpose of determining whether the chemical presents an unreasonable risk to humans or the environment in the U.S.
- Under U-V CSIA Section 12(b), export notices are required to be submitted on chemicals for which actions have been proposed or finalized under Sections 5 or 6 and, in an important change relative to the approach in CSIA1, 'for which the submission of information is required under Section 4.' Although consistent with TSCA Section 12(b) (in that Section 4 actions triggered export notification requirements), this latter change seemingly greatly increases the universe of chemicals for which such notices would have been required compared to CSIA1.
Section 13 Imports
U-V CSIA proposes some important new provisions, including ones regarding certification for articles and a description of what constitutes 'reasonable inquiry' in preparing an import certification. Boxer TSCA accepts most of the changes with one important exception.
- U-V CSIA Section 13(a) specifies that import shall be refused for a chemical or article containing a chemical that has been banned under Section 6, is not included on the 'active' list, or is offered for import in violation of an action under the Act.
- U-V CSIA Section 13(b) Certification includes several important additions to the provisions, as follows:
- While EPA may by rule require import certifications for articles that contain a substance regulated under Sections 5 or 6, EPA must identify the 'types of articles' with 'reasonable specificity' and needs to consider the risk contribution of the article, the utility of such certification, the commercial impact of the certification in impeding or disrupting import of articles, and specification of the concentration level within an article that would be covered.
- U-V CSIA helpfully includes a new provision describing requirements for a 'reasonable inquiry' for import certification.
- Regarding the articles provisions that appeared in U-V CSIA, Boxer TSCA would delete the requirement at Section 13(b)(2) that had otherwise required that EPA identify 'types of articles' subject to certification. Importantly, and perhaps surprisingly, other changes to this subsection are accepted.
Section 14 CBI
U-V CSIA proposes major changes to this section as it had appeared in CSIA1. Boxer TSCA accepts many of the changes but makes a number of important revisions.
- Retains CSIA1 Section 14(b) Information Generally Protected from Disclosure but states that the Act shall not act to prohibit disclosure in a state or federal judicial process. Other changes include:
- Whereas CSIA1 had protected '[t]he identity of constituents in a mixture' from disclosure, U-V CSIA changes this to '[d]etails of the full composition of the mixture,' which strikes us as not very clear while seemingly limiting the protection afforded.
- While U-V CSIA protects chemical identity from disclosure 'prior to the date on which it is first offered for commercial distribution,' this provision appears to preclude a company from claiming a CBI chemical identity for a substance that had once been in commerce but is now reentering commerce. This also applies to chemical identities that otherwise had not been protected or were no longer protected from CBI. While this may make sense at some level, precluding CBI claims for such chemicals seems likely to disadvantage companies that reintroduce such chemicals for possibly innovative new uses that may be unrelated to historical uses.
- No protection is afforded for any CBI claims on a chemical if EPA promulgates a rule to ban or phase-out a chemical; further, EPA is promptly to make such information public.
- U-V CSIA substantially revises Section 14(d) Requirements for Confidentiality Claims, including:
- Requiring that such claims be substantiated at the time of submission, which must include a statement supporting the assertion of a claim.
- The text has been clarified to read that in several instances these statements should provide a 'reasonable basis' to believe or to conclude, which seems a helpful clarification of what is expected to be provided.
- If the chemical identity is claimed as CBI, the submitter must provide a structurally descriptive generic name and EPA is to provide guidance on how to do this.
- U-V CSIA Section 14(e) Exceptions to Protection from Disclosure generally follows the approach in CSIA1 although the exceptions are somewhat expanded, including to parties responding to environmental emergencies.
- U-V CSIA Section 14(f) Duration of Protection from Disclosure applies a ten-year limitation for CBI claims. Before expiration of the time limit, EPA is required to notify (at least 60 days prior) and the party must reply with a reassertion within 30 days, and EPA has 30 days to make a determination, which can be to grant an extension for another ten years (with no limit on the number of extensions) or to deny the request.
- Subsection (2) Review and Resubstantiation includes a number of new and specific provisions that, among others, allow EPA to review a CBI claim at any time and request that the claim be withdrawn or be resubstantiated, including, 'in limited circumstances,' when EPA determines that disclosure of certain information would assist EPA in conducting safety assessments and determinations.
- U-V CSIA Section 14(f)(3) includes a new requirement for EPA to develop a 'unique identifier' for each CBI chemical identity and the information on the chemical is organized under that identifier (the purpose seemingly is to allow EPA to consolidate and release non-CBI on the chemical (e.g., such as that received under the Chemical Data Reporting (CDR) rule).
- Related to this is a provision at CSIA Section 14(f)(3)(B) that requires EPA to publish a list of the chemicals claimed as CBI -- with the unique identifier -- and expiration dates for CBI claims.
- Under Section 14(g) Duties of the Administrator, U-V CSIA adds specificity to the EPA obligations, including time deadlines for CBI determinations and requires EPA to review 100 percent of CBI claims for chemical identify and a 'representative subset' of at least 25 percent of the CBI claims for other information.
- U-V CSIA Section 14(h) Criminal Penalty for Wrongful Disclosure would delete the requirement for removal from office of an EPA employee for wrongful disclosure of CBI.
- Whereas U-V CSIA Section 14(b) had created a presumption that certain information identified in Section 14(b)(2) that otherwise meets the requirements at Section 14(d) should be generally protected, Boxer TSCA removes the concept of presumption but states that the information described in subparagraph (2) 'shall be protected' except that:
- The Section 14(e) exceptions to protection from disclosure apply;
- The information is subject to the Section 14(f)(2) provisions regarding review and resubstantiation; and
- Consistent with U-V CSIA, disclosure is not prohibited in state or federal judicial processes.
- Boxer TSCA makes several important revisions to U-V CSIA Section 14(b)(2) concerning protected information, including:
- Revising the provision concerning 'details of the full composition of a mixture and the respective percentages of constituents' to read simply 'the percentages of the components of a mixture,' thus potentially putting information concerning the identities of the components at risk of disclosure.
- Seemingly removing chemical identity protection from chemicals that appear on the list of inactive substances created under Section 8.
- Boxer TSCA at Section 14(f)(2) Review and Resubstantiation would at Subsection (A)(vii) give EPA explicit authority to undertake such a review of information contained in a Section 8(e) notice of substantial risk.
Section 16 Penalties
U-V CSIA would increase penalty amounts to $37,500 for each civil violation and to $50,000 for each criminal violation. It also includes a new penalty for a party that knowingly puts parties in imminent danger -- $250,000 per person and $1,000,000 for an organization. Boxer TSCA accepts these changes without modification.
Section 18 Preemption
U-V CSIA proposes a substantial rewrite to this section as it appeared in CSIA1 seemingly in an attempt to balance out better the competing interests. Boxer TSCA proposes to delete all the U-V CSIA proposed text and replace it with a provision entitled 'Savings' that flatly states there is no preemption of common law rights or federal or state statutory remedies for civil relief, tort liability, private remedies, or actions based on state laws (including regulations, safety determinations, and scientific assessments, among others).
This section of U-V CSIA includes a number of revisions that clarify and to some extent limit the scope of preemption relative to that in CSIA1, although the effect is limited.
- U-V CSIA Section 18(a) would preempt certain state action, including:
- Testing and information actions that are likely to produce the same information as actions taken under TSCA Sections 4, 5, or 6.
- Prohibition or restriction actions on a chemical found to meet the safety standard and for a chemical found not to meet the safety standard to the extent 'consistent with the scope of the [EPA] determination.' U-V CSIA also identifies the date for preemption -- date of EPA's determination that a chemical substance meets the safety standard or when compliance with the Section 6(d) risk management rule is required). CSIA Section 18(b) also preempts state action 'except as provided in subsections (c) and (d)' for:
- '[H]igh priority' chemicals when EPA commences the Section 6 safety assessment.
- '[L]ow priority' chemicals as of the date of such designation.
- U-V CSIA Section 18(c) discusses a number of exceptions to preemptions, including when state action is pursuant to another federal law or relates to air or water quality, waste disposal that does not impose a restriction on manufacture/processing/use, and is not 'inconsistent' with EPA action.
- U-V CSIA Section 18(d) provides explicit protection for 'warning requirements' such as California's Proposition 65.
- U-V CSIA Section 18(e) State Waivers includes a new waiver provision if the state goes to the NAS and bases a regulation on that result.
- The section also includes several new savings clauses to protect tort proceedings (the Act does not preempt or displace opportunities for civil actions).
Section19 Judicial Review
This section appears to retain TSCA's 'substantial evidence' standard. It is difficult to discern why this seems to remain given the significant debate that has surrounded this standard.
Section 26 Administration
Neither CSIA1 nor U-V CSIA proposed other than conforming changes to this section of TSCA. Boxer TSCA proposes important new changes to Section 26(b) Fees to give EPA authority to require manufacturers to pay 'reasonable fees' to defray the costs of administering the Act. The fees are to be apportioned among individual manufacturers based on production or importation of chemicals, with an ability for multiple manufacturers of a given chemical to share the fee costs based on their respective volumes. EPA may set separate fees for small businesses based on their ability to pay. Fees are to be used only to defray costs of administering the Act. Finally, EPA must ensure that the fees are set at a level sufficient to add three chemicals to the priority list for each one removed and to complete safety assessments and determinations and any rulemaking under Section 6(a).
This latest draft of TSCA amendments represents significant movement, and we believe progress, from earlier drafts, both in terms of practical reforms to the current law and important political concessions to critics of past drafts. That Senators Udall and Vitter collaborated on yet another attempt at compromise is newsworthy. Even more surprising is how far this current draft goes towards giving EPA vastly increased powers to impose testing requirements, to prioritize and assess chemicals, and to control identified chemical risks with enhanced tools and authority, all of which is to be pursued within vigorous deadlines. There will be and are critics who believe that almost any draft is 'not good enough.' Even this current draft has already received the now routine snipe that 'this is no better than current law.'
This characterization is both laughable and lamentable. The proposal, warts and all from any view, is a drastic enhancement of EPA's current regulatory authority. While improvements and clarifications are plainly needed, the proposal represents substantial movement toward addressing the criticism of environmental groups of many past drafts. That does not make it desirable or perfect, nor is it intended to suggest that remaining criticism by environmental groups or others is off base.
Any level of preemption, for example, of state regulatory authority may be flatly unacceptable to certain groups. What is more disappointing, however, is the shrill and somewhat reflexive response that drowns out any acknowledgement of what seems to have been an honest attempt by Senators Udall and Vitter to find compromise to this difficult issue. As shown in our analysis, there are numerous provisions where the Boxer version accepted with little or no change revisions proposed by Udall-Vitter. Unfortunately this is not readily discernible in the Boxer version released. This is what prompted us to attempt to understand the scope and specifics of the changes against the original CSIA. The larger problem, if legislative success is the goal, is that this lack of acknowledgement of the tremendous movement towards giving EPA significantly new and greatly enhanced authority diminishes the prospect of ever achieving successful legislation.
This outcome may not be disappointing to some constituencies. Given that the loudest critics of the current law are those who seek greater testing and controls on chemicals, retaining the current law would seem an unattractive option. From this perspective, the chemical industry might be expected to at least implicitly welcome the status quo. To our eye, however, while the original CSIA could be characterized as leaning more in the direction of industry, the balance point has been shifted in the Udall-Vitter text such that, if anything, it now inclines more toward environmental groups.
The current attempt outlined in this analysis, if nothing else, represents a serious and bona fide attempt to give EPA more authority and would increase the amount of chemical test data and information available to EPA and the public, jump start a process that over time would consider and prioritize chemicals for risk assessment and regulatory oversight, and allow EPA to impose regulatory controls more easily, or certainly more routinely, than under current law. It is all the more surprising that no criticism has been heard to date from industry while certain, but fortunately not all, environmental groups have raised criticisms and issues while neglecting to acknowledge the extent of the progress obtained.
Does that make the current proposal perfect? Far from it and, as mentioned, some may find fundamental flaws, and all will see the need for further improvements and clarifications in the current draft. But for an issue where traditionally opposing parties have had an agreement on 'principles' since 2009, the acrimony underlying the rhetoric is a bit surprising even for the current Congressional atmosphere of bitter partisan rhetoric and sometimes ad-hominem attacks among members of both the House and the Senate.
It is unclear what happens now. This session of Congress is essentially over, and even if a lame duck session ensues, TSCA reform may not make the short list of must-have legislation. The prospect of Republican control of the Senate after the 2014 elections adds another element of speculation and hypothetical outcomes. That Senator Vitter is running for Governor of Louisiana adds another element of uncertainty as it is by no means clear TSCA reform will continue to be a priority. As failure is an orphan and success has many parents, various players who have been reported to be at the table while formulating the Udall-Vitter draft are now claiming the draft is apparently of virgin birth. Who and how strenuously any constituency will stand behind the current text next year is unclear at best.
What will be most valuable, regardless of party control and personalities, is the current drafts' outline of greatly enhanced authority for EPA to impose testing requirements, prioritize and assess chemicals, and begin to move to control identified risks. The legislation can and should be refined to define better many of the key terms in the proposal, and the provisions regarding deadlines for various deliverables (regulations, risk assessments, and related deliverables) seems to have been written by a team none of whom has ever worked in a federal regulatory agency. This further assumes some acceptable 'compromise' on the issue of state preemption can be reached.
The battling parties should, however, be reminded of what brought them to the table in the first place: the need for reform to authorize a more effective TSCA, and some kind of public assurance that EPA is doing its job sufficiently robustly to minimize the need for or the likelihood of proliferating any inconsistent state and local regulation of chemical use. That is what underlies the move towards compromise, and those dynamics remain. What is missing, still, is a willingness for a sufficiently large and powerful enough number of relevant players to 'just do it.'