82 FR 4825 - Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act
ENVIRONMENTAL PROTECTION AGENCY Federal Register Volume 82, Issue 10 (January 17, 2017)
Federal Register Volume 82, Issue 10 (January 17, 2017)
| Page Range | 4825-4837 | |
| FR Document | 2017-00051 |
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)] [Proposed Rules] [Pages 4825-4837] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-00051] ----------------------------------------------------------------------- ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 702 [EPA-HQ-OPPT-2016-0636; FRL-9957-74] RIN 2070-AK23 Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act AGENCY: Environmental Protection Agency (EPA). ACTION: Proposed rule. ----------------------------------------------------------------------- SUMMARY: As required under section 6(b)(1) of the Toxic Substances Control Act (TSCA), EPA is proposing to establish a risk-based screening process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. The proposed rule describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and finalizing designations of priority. Prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under recent amendments to TSCA. DATES: Comments must be received on or before March 20, 2017. ADDRESSES: Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0636, by one of the following methods:Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Mail: Document Control Office (7407M), Office of Pollution Prevention and Toxics (OPPT), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html. Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: For technical information contact: Ryan Schmit, Immediate Office, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- 0001; telephone number: (202) 564-0610; email address: [email protected]. For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: [email protected]. SUPPLEMENTARY INFORMATION: I. Executive Summary A. Does this action apply to me? This proposed rule does not propose to establish any requirements on persons or entities outside of the Agency. This action may, however, be of interest to entities that are or may manufacture or import a chemical substance regulated under TSCA (e.g., entities identified under North American Industrial Classification System (NAICS) codes 325 and 324110). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities and corresponding NAICS codes for entities that may be interested in or affected by this action. B. What action is the agency taking? EPA is proposing to establish the internal processes and criteria by which EPA will identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. C. Why is the agency taking this action? This rulemaking is required by TSCA section 6(b)(1)(A). Prioritization of chemical substances for further evaluation will ensure that the Agency's limited resources are conserved for those chemical substances most likely to present risks, thereby furthering EPA's overall mission to protect health and the environment. D. What is the agency's authority for taking this action? EPA is proposing this rule pursuant to the authority in TSCA section 6(b), 15 U.S.C. 2605(b). See also the discussion in Units II.A and B. E. What are the estimated incremental impacts of this action? This is a proposed rule that would establish the processes by which EPA intends to designate chemical substances as either High or Low- Priority Substances for risk evaluation. It would not establish any requirements on persons or entities outside of the Agency. EPA did not, therefore, estimate potential incremental impacts from this action. F. What should I consider as I prepare my comments for EPA? 1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that [[Page 4826]] you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. 2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html. II. Background A. Recent Amendments to TSCA On June 22, 2016, the President signed into law the ``Frank R. Lautenberg Chemical Safety for the 21st Century Act'' (Pub. L. 114- 182), which imposed sweeping reforms to TSCA. The bill received broad bipartisan support in the U.S. House of Representatives and Senate, and its passage was heralded as the most significant update to an environmental law in over 20 years. The amendments give EPA improved authority to take actions to protect people and the environment from the effects of dangerous chemical substances. Additional information on the new law is available on EPA's Web site at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/frank-r-lautenberg-chemical-safety-21st-century-act. When TSCA was originally enacted in 1976, it established an EPA- administered health and safety review process for new chemical substances prior to allowing their entry into the marketplace. However, tens of thousands of chemical substances in existence at that time were ``grandfathered in'' with no requirement for EPA to ever evaluate their risks to health or the environment. The absence of a review requirement or deadlines for action, coupled with a burdensome statutory standard for taking risk management action on existing chemical substances, resulted in very few chemical substances ever being assessed for safety by EPA, and even fewer subject to restrictions to address identified risks. One of the key features of the new law is the requirement that EPA now systematically prioritize and assess existing chemical substances, and manage identified risks. Through a combination of new authorities, a risk-based safety standard, mandatory deadlines for action, and minimum throughput requirements, TSCA effectively creates a ``pipeline'' by which EPA will conduct existing chemical substances review and management. This new pipeline--from prioritization to risk evaluation to risk management (when warranted)--is intended to drive steady forward progress on the backlog of existing chemical substances left largely unaddressed by the original law. Prioritization is the initial step in this process. B. Statutory Requirements for Prioritization TSCA section 6(b)(1) requires EPA to establish, by rule, the process and criteria for prioritizing chemical substances for risk evaluation. Specifically, the law requires EPA to establish ``a risk- based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low- priority substances for which risk evaluations are not warranted at the time.'' TSCA sections 6(b)(1) through (3) provide further specificity on both the process and criteria, including preferences for certain chemical substances that EPA must apply, the procedural steps, definitions of High-Priority Substances and Low-Priority Substances, and screening criteria that EPA must consider in designating a chemical substance as either High-Priority Substances or Low-Priority Substances. The statutory requirements related to prioritization are described in further detail in this unit. 1. Prioritization Steps. Based on TSCA sections 6(b)(1) through (3), EPA is proposing to include four steps or phases in prioritization: (1) Pre-Prioritization, (2) Initiation, (3) Proposed Designation, and (4) Final Designation. During the Pre-Prioritization phase, EPA is proposing to apply the statutory preferences in TSCA section 6(b)(2), along with other criteria, to narrow the pool of potential candidates, and identify a single chemical substance (or category of chemical substances) to screen against the statutory criteria in TSCA section 6(b)(1)(A). Aside from the statutory preferences listed, the law does not direct or limit EPA in how it is to ultimately select a chemical substance on which to initiate prioritization, requiring only that the process be ``risk-based.'' At the Initiation step, EPA must announce a candidate chemical substance and give the public a 90-day comment period to submit relevant information. 15 U.S.C. 2605(b)(1)(C)(i). At the Proposed Designation step, EPA must propose to designate a chemical substance as either a High-Priority Substance or a Low-Priority Substance, publish the proposed designation and the information, analysis, and basis used to make the designation, and take public comment a second time for 90 days. 15 U.S.C. 2605(b)(1)(C)(ii). At Final Designation, EPA must either finalize a High-Priority Substance designation and initiate a risk evaluation, or finalize a Low-Priority Substance designation in which case it will not conduct a risk evaluation on the chemical substance unless and until information leads EPA to revisit that priority designation. 15 U.S.C. 2605(b)(3)(A) and (B). 2. Screening criteria and statutory preferences. The statute defines a High-Priority Substance as one that the Administrator concludes, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by the Administrator. 15 U.S.C. 2605(b)(1)(B)(i). Conversely, the law specifies that a Low-Priority Substance is one that the Administrator concludes, based on information sufficient to establish, without consideration of costs or other non-risk factors, does not meet the standard for designating a chemical substance a High-Priority Substance. 15 U.S.C. 2605(b)(1)(B)(ii). In designating the priority of a chemical substance, EPA must screen a candidate chemical substance against certain criteria specified in TSCA section 6(b)(1)(A). These include the hazard and exposure potential of the chemical substance (e.g., persistence and bioaccumulation, potentially exposed or susceptible subpopulations, and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed. EPA interprets ``significant changes in'' conditions of use to have relevance primarily in the context of revising a priority designation. With respect to an initial prioritization decision, any changes in use that have occurred in the past would already be captured by the concept of ``conditions of use,'' as defined in TSCA section 3. [[Page 4827]] The results of this screen will help inform EPA's proposed priority designation. However, given that the statutory deadlines are triggered at the initiation of prioritization, and that EPA will want to have a good understanding of the chemical substance before triggering those deadlines, EPA will consider these screening criteria earlier in the process. As discussed in more detail in Unit III., EPA is therefore proposing to include the screening review in the rule as part of the pre-prioritization phase. In designating High-Priority Substances, EPA is to give preference to chemical substances that are listed in the 2014 Update of the TSCA Work Plan for Chemical Assessments (Ref. 1) that: (1) Have persistence and bioaccumulation scores of 3; and (2) are known human carcinogens and have high acute and chronic toxicity. 15 U.S.C. 2605(b)(2)(D). The law further requires that 50% of all ongoing risk evaluations be drawn from the 2014 Update to the TSCA Work Plan for Chemical Assessments, meaning that, at least at the outset of the program, EPA will need to draw at least 50% of High-Priority Substance designations from the same list. 15 U.S.C. 2605(b)(2)(B). 3. Metals and metal compounds. When prioritizing metals or metal compounds, EPA must use the March 2007 Framework for Metals Risk Assessment of the Office of the Science Advisor (Ref. 2) (or a successor document that addresses appropriate considerations for conducting a risk assessment on a metal or metal compound and is peer reviewed by the Science Advisory Board). 15 U.S.C. 2605(b)(2)(E). However, during the prioritization process, EPA will not be conducting chemical risk assessments; and, consequently, much of this guidance will not be directly relevant. EPA interprets this provision to ensure that the analysis and considerations during the prioritization process take into account the special attributes and behaviors of metals and metal compounds that are relevant to judgments of risk. For example, this might include consideration of the document's Key Principles that differentiate inorganic metals and metal compounds from organic and organometallic compounds, and their unique attributes, properties, issues, and processes. Because EPA will not conduct risk assessments on metals or metal compounds for purposes of prioritization, EPA will not refer to sections that provide guidance on how to incorporate the Key Principles into risk assessments. 4. Timeframe. TSCA requires that the prioritization process last between nine and twelve months. 15 U.S.C. 2605(b)(1)(C). This timeframe takes on particular significance, given that the statute does not authorize EPA to ``pause'' or delay the prioritization once it has been initiated, and that a final High-Priority Substance designation results in the chemical substance moving immediately into a risk evaluation process that must be generally completed within three years. 15 U.S.C. 2605(b)(4)(G). 5. Opportunities for public participation. As already mentioned, TSCA requires EPA to provide two 90-day public comment periods during prioritization--one following initiation, and a second following a proposed designation. 15 U.S.C. 2605(b)(1)(C)(i) and (ii). TSCA further requires that EPA include a process for extending the comment deadline for up to three months in order to receive or evaluate information coming from a TSCA section 4 test order. 15 U.S.C. 2605(b)(1)(C)(iii). These public comment periods, coupled with the nine month minimum timeframe for prioritization, ensure that the public will be on notice of EPA's intention to further evaluate a chemical's risks and will have opportunity to engage early in the process before the risk evaluation has started. 6. Default to High-Priority Substance Designation. If, after prioritization has been initiated, the public has been given an opportunity to submit relevant information, and EPA has extended the comment period pursuant to TSCA section 6(b)(1)(C)(iii) in order to receive or evaluate additional information, EPA determines that the available information is insufficient to enable the designation of the chemical substance as a Low-Priority Substance, the statute requires EPA to propose a High-Priority Substance designation. 15 U.S.C. 2605(b)(1)(C)(iii). Based in part on this provision, and as discussed further in Unit III, EPA is proposing to require a default-to-high in all cases in which insufficient information exists to designate the chemical as a Low-Priority Substance at both the proposed and final designation. 7. Initial ten chemicals for risk evaluation. TSCA requires EPA to, within six months of enactment, ensure that risk evaluations are being conducted on ten chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments, and to publish a list of those chemical substances during that same period. 15 U.S.C. 2605(b)(2)(A). The initial ten chemical substances are not subject to the prioritization process or the procedures in this rule. However, completion of these risk evaluations triggers the ongoing designation requirement discussed in Unit II.B.8. 8. Ongoing designations. Upon completion of a risk evaluation (other than those requested by a manufacturer pursuant to TSCA section 6(b)(4)(C)(ii)), EPA must designate at least one additional High- Priority Substance to take its place. 15 U.S.C. 2605(b)(2)(C). Because designation as a High-Priority Substance results in the chemical substance moving immediately to risk evaluation, this provision prevents the number of existing chemical substances undergoing risk evaluation from ever decreasing over time. In addition, EPA must designate at least twenty chemical substances as High-Priority Substances by three and one half years after enactment, effectively doubling the number of chemical substances in the review pipeline. 15 U.S.C. 2605(b)(2)(B). The statute also requires that at least twenty chemical substances be designated as Low-Priority Substances by three and one half years after enactment, but without a comparable requirement to continue designating additional Low-Priority Substances after that. 15 U.S.C. 2605(b)(2)(B), (b)(3)(C). Although EPA must continue to prioritize and evaluate chemical substances ``at a pace consistent with the ability of the Administrator to complete risk evaluations in accordance with the deadlines,'' this provision does not modify the minimum throughput or other ongoing designation requirements for High-Priority Substances. 15 U.S.C. 2605(b)(2)(C). It does, however, suggest that EPA must have adequate resources should EPA plan to designate more than twenty chemical substances as High-Priority Substances at any given time. 9. Revision of designation. TSCA allows the Administrator to revise the designation of a Low-Priority Substance to a High-Priority Substance ``based on information made available to the Administrator.'' 15 U.S.C. 2605(b)(3)(B). This provision does not restrict the basis for a revision to the discovery or receipt of new information. For example, EPA could also justify a revision based on information that was available but was not considered at the time of the original prioritization decision, or information that was considered but which EPA now views differently as a result of changes in scientific understanding (e.g., changes in scientific understanding of how a chemical can enter or interact with the human body). 10. Other relevant statutory requirements. TSCA imposes new [[Page 4828]] requirements on EPA in a number of different areas that EPA is not proposing to incorporate or otherwise address in this proposed rule. For example, amendments to TSCA section 4 require EPA to ``. . . reduce and replace, to the extent practicable, [. . .] the use of vertebrate animals in the testing of chemical substances . . .'' and to develop a strategic plan to promote such alternative test methods. 15 U.S.C. 2603(h). Likewise, TSCA section 26 requires, to the extent that EPA makes a decision based on science under TSCA sections 4, 5, or 6, that EPA use certain scientific standards and base those decisions on the weight of the scientific evidence. 15 U.S.C. 2625(h) and (i). While these requirements are relevant to the prioritization of chemical substances, EPA is not obliged to include them in this proposed rule. By their express terms, these statutory requirements apply to EPA's decisions under TSCA section 6, without the need for regulatory action. Moreover, in contrast to TSCA section 6, Congress has not directed EPA to implement these other requirements ``by rule;'' it is well- established that where Congress has declined to require rulemaking, the implementing agency has complete discretion to determine the appropriate method by which to implement those provisions. E.g., United States v. Storer Broadcasting Co., 351 U.S. 192 (1956). A number of stakeholders raised questions as to whether EPA should define a number of important terms in this rule (e.g., ``best available science'', ``weight-of-the-evidence'', ``sufficiency of information'', ``unreasonable risk'', and ``reasonably available information''). Many of the terms used in the proposed rule are not novel concepts and are already in use, and their meaning is discussed extensively in existing Agency guidance. For example, extensive descriptions for the phrases ``best available science'', ``weight-of-the-evidence'', and ``sufficiency of information'' can be found in EPA's Risk Characterization Handbook (Ref. 3), and in other existing Agency guidance. EPA believes further defining these and other terms in the proposed rule is unnecessary and ultimately problematic. These terms have and will continue to evolve with changing scientific methods and innovation. Codifying specific definitions for these phrases in this rule may inhibit the flexibility and responsiveness of the Agency to quickly adapt to and implement changing science. The Agency intends to use existing guidance definitions and to update definitions and guidance as necessary. While EPA is seeking public comment on all aspects of this proposed rule, the Agency is specifically requesting public input on this issue. The Agency welcomes public comments regarding the pros and cons of codifying these or other definitions and/or approaches for these or any other terms. EPA encourages commenters to suggest alternative definitions the Agency should consider for codification in this procedural rule. Please explain your views as clearly as possible, providing specific examples to illustrate your concerns and suggest alternate wording, where applicable. C. Prioritization Under the 2012 TSCA Work Plan Methodology Prioritization of chemical substances for review is not a novel concept for the Agency. In 2012, EPA released the TSCA Work Plan Chemicals: Methods Document in which EPA described the process the Agency intended to use to identify potential candidate chemical substances for near-term review and assessment under TSCA (Ref. 4). EPA also published an initial list of TSCA Work Plan chemicals identified for further assessment under TSCA as part of its chemical safety program in 2012 (Ref. 5), and an updated list of chemical substances for further assessment in 2014 (Ref. 1). The process for identifying these chemical substances was based on a combination of hazard, exposure, and persistence and bioaccumulation characteristics. Congress expressly recognized the validity of EPA's existing prioritization methodology for the TSCA Work Plan. For example, the law requires that EPA give certain preferences to chemical substances listed on the 2014 Update to the TSCA Work Plan. 15 U.S.C. 2605(b)(2)(D). Moreover, the law requires that at least 50 percent of all ongoing risk evaluations be drawn from the 2014 Update to the TSCA Work Plan. 15 U.S.C. 2605(b)(2)(B). The statutory screening criteria in TSCA section 6(b)(1)(A) also significantly overlaps with the considerations in the Work Plan methodology (e.g., persistence, bioaccumulation, toxicity, carcinogenicity, etc.). However, there are a number of key differences between EPA's TSCA Work Plan process and the prioritization process that TSCA now requires. First, the Work Plan process involved culling through thousands of chemical substances to create a list that EPA could, over time and without prescribed deadlines, focus its limited resources on. The TSCA Work Plan did not require EPA to assess listed chemical substances, and included no deadlines for completing risk assessments or addressing identified risks. Prioritization under this proposed rule will involve a similar culling, but upon designating a chemical substance as a High-Priority Substance, the Agency must start a risk evaluation, and generally complete that evaluation within a specified amount of time. If EPA determines in the risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must also initiate a risk management rulemaking subject to statutory deadlines. 15 U.S.C. 2605(c). As such, EPA will need to be judicious in selecting the chemical substances that go into prioritization. Further, while chemical substances listed on the TSCA Work Plan were likely to be well-characterized for hazard and have at least some information indicating potential exposure, Work Plan chemical substance assessments have generally focused on specific chemical uses. Given the statutory deadlines, EPA generally intends to ensure it has a more complete set of data upfront that would allow EPA to evaluate a chemical substance under all conditions of use (a broader scope) within the statutory deadlines. For chemical substances with insufficient information to conduct a risk evaluation, EPA generally expects to pursue a significant amount of data gathering before initiating prioritization. Finally, the TSCA Work Plan process focused solely on identifying potential high risk chemical substances for further review. Because the statute also requires the identification of Low-Priority Substances-- those chemical substances that EPA has determined, based on sufficient evidence, do not warrant further review at the time--EPA will need to undertake new and different analyses than it has done to date under the TSCA Work Plan. While EPA has drawn from the TSCA Work Plan methodology and EPA's experience in implementing that process in developing this proposed rule, EPA is proposing to tailor the process for prioritization to the specific requirements in the new statute. D. Stakeholder Involvement On August 10, 2016, EPA held a one day public meeting to hear from stakeholders to better understand their viewpoints on the development of the prioritization rule. The meeting began with a presentation from EPA on how the Agency has prioritized chemicals for further review under the TSCA Work Plan methodology. The remainder of the day was reserved for public comment. Commenters had approximately four [[Page 4829]] minutes to present their comments orally and there was a total of 28 oral comments on the prioritization rule. Further information is available on EPA's Web site at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/meetings-and-webinars-amended-toxic-substances-control. Stakeholders were also able to provide written comments. EPA received 50 written comments on the prioritization rule, although many of those who presented orally also submitted written versions as well. These comments and a transcript of the meeting are accessible in the meeting's docket, identified by Docket ID No. EPA-HQ-OPPT-2016-0399, available online at https://www.regulations.gov/. The commenters included representatives from industry, environmental groups, academics, private citizens, trade associations, and health care representatives, and provided a diversity of perspectives. Overall, there was a general expression of support for the new law and EPA's inclusive approach to implementation to date. Most groups agreed that the prioritization rule had the potential to increase transparency in EPA's chemical substance review and management process, and urged the Agency to work towards this goal. A number of commenters suggested codifying specific details in the rule, such as a system for scoring and ranking chemical substances; a listing of the specific hazard and exposure information upon which EPA will base prioritization decisions; and definitions of terms referenced in the statute like ``weight of evidence'' and ``best available science.'' Others encouraged EPA to keep the rules focused on a framework for general process, to retain Agency discretion where appropriate, and to reserve specific scientific considerations for Agency guidance. EPA considered all of these comments in the development of this proposed rule, and welcomes additional feedback from stakeholders on the Agency's proposed process for chemical substance prioritization as presented in this document. III. Summary of Proposed Rule This proposed rule incorporates all of the elements required by statute, but also supplements those requirements with additional criteria the Agency expects to consider, some clarifications for greater transparency, and additional procedural steps to ensure effective implementation. Specific components of the approach are discussed in this unit. EPA requests comments on all aspects of this proposed rulemaking. A. Policy Objective The prioritization process under TSCA is the principal gateway to risk evaluation. EPA is ultimately making a judgment as to whether or not a particular chemical substance warrants further assessment. As a general matter, the overall objective of the process should be to guide the Agency towards identifying the High-Priority Substances that have the greatest hazard and exposure potential first. EPA may also consider the relative hazard and exposure of a potential candidate's likely substitute(s) in order to avoid moving the market to a chemical substance of equal or greater risks. However, the prioritization process is not intended to be an exact scoring or ranking exercise and EPA is not proposing such a system in this rule. The precise order in which EPA identifies High-Priority Substances (all of which must meet the same statutory standard) should not be allowed to slow the Agency's progress towards fully evaluating the risks from those chemical substances. Further, the level of analysis necessary to support an exact ranking system is not appropriate at the prioritization stage, where the sole outcome is a decision on whether EPA will further evaluate the chemical substance. EPA intends to conserve its resources and the Agency's deeper analytic efforts for the actual risk evaluation. This policy objective is stated directly in the proposed rule. Low-Priority Substance designations serve some of the same policy objectives. Although the statute does not require EPA to designate more than twenty Low-Priority Substances, doing so ensures that chemical substances with clearly low hazard and exposure potential are taken out of consideration for further assessment, thereby conserving resources for the chemical substances with the greatest potential risks. There is also value in identifying Low-Priority Substances as part of this process, as it gives the public notice of chemical substances for which potential risks are likely low or nonexistent, and industry some insight into which chemical substances are likely not to be regulated under TSCA. B. Scope of Designations EPA will designate the priority of a ``chemical substance,'' as a whole, under this established process, and will not limit its designation to a specific use or subset of uses of a chemical substance. EPA is proposing this in response to clear statutory directives: The relevant provisions of TSCA section 6 repeatedly refer to both the designation and evaluation of ``chemical substances'' under the ``conditions of use.'' ``Conditions of use'' are broadly defined as ``the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.'' 15 U.S.C. 2602. Although some commenters at the public meeting suggested that the prioritization process should allow EPA to designate a specific use of a chemical substance as a High-Priority Substance or a Low-Priority Substance, EPA does not interpret the statute to support such an interpretation. To the contrary, the addition of the phrase ``conditions of use'' (emphasis added) was intended to move the Agency away from its past practice of assessing only narrow uses of a chemical substance, towards a comprehensive approach to chemical substance management. While EPA clearly retains some discretion in determining those conditions of use, as a matter of law, EPA considers that it would be an abuse of that discretion to simply disregard known, intended, or reasonably foreseen uses in its analyses. C. Timeframe As discussed in Unit II., TSCA section 6(b)(1)(C) requires that the prioritization process last between nine and twelve months. EPA is proposing in this rule that initiation of the prioritization begins upon publication of a notice in the Federal Register that identifies a chemical substance for prioritization and provides the results of the screening review. The process is complete upon publication of a notice in the Federal Register announcing a final priority designation. Accordingly, the proposed rule specifies that the process--from initiation to final designation--shall last between 9 and 12 months. This timeframe serves dual purposes. The minimum 9-month timeframe ensures that the general public; potentially-affected industries; state, tribal and local governments; environmental and health non- governmental organizations; and others have ample notice of upcoming federal action on a given chemical substance, and opportunity to engage with EPA early in the process. The 12-month maximum timeframe, coupled with the default-to-high provision discussed later, keeps the existing chemical substances review pipeline in a forward motion, and prevents EPA from getting mired in analysis before ever reaching the risk evaluation step. [[Page 4830]] D. Categories of Chemical Substances TSCA section 26 provides EPA with authority to take action on categories of chemical substances. 15 U.S.C. 2625(c). ``Category of Chemical Substances'' is defined at 15 U.S.C. 2625(c)(2)(A). Although the proposed rule most often references ``chemical substances,'' EPA is also proposing to include a clear statement in the regulation that nothing in the proposed rule shall be construed as a limitation on EPA's authority to take action with respect to categories of chemical substances, and that, where appropriate, EPA can prioritize and evaluate categories of chemical substances. E. Chemicals Subject to Prioritization Generally, all chemical substances listed on the TSCA Inventory are subject to prioritization. TSCA contemplates that, over time, all chemical substances on the TSCA Inventory will be prioritized into either High- or Low-Priority Substances, and that all High-Priority Substances will be evaluated. EPA notes that chemical substances newly added to the TSCA Inventory following EPA's completion of pre- manufacture review under section 5 of TSCA (15 U.S.C. 2604) are also candidates for prioritization, although EPA expects that such chemical substances are not likely to be High-Priority candidates in light of the risk-related determination that the Agency must make pursuant to TSCA section 5(a)(3). TSCA further requires EPA to go through a separate process of determining which chemical substances on the TSCA Inventory are still actively being manufactured, and EPA has initiated a separate rulemaking for that purpose (RIN 2070-AK24). This distinction will inform EPA's exposure judgments during the prioritization process. However, there is nothing in TSCA that prohibits EPA from initiating the prioritization process on an ``inactive'' chemical substance and ultimately designating that chemical substance as either a High- Priority Substances (e.g., if exposures of concern arise from ongoing uses) or Low-Priority Substance. F. Pre-Prioritization Considerations As discussed earlier, TSCA requires that EPA establish a process, including criteria for designating a chemical substance as either a High-Priority Substances or Low-Priority Substance. 15 U.S.C. 2605(b)(1). Aside from the statutory preferences for chemical substances on the 2014 Update to the TSCA Work Plan (Ref. 1), the statute leaves EPA with broad discretion to choose which chemical substance to put into that process. Accordingly, this proposed rule includes a discussion of the criteria EPA expects to use to cull through the chemical substances on the TSCA Inventory. These include criteria that will be used to identify potential candidates for High- Priority Substances or Low-Priority Substances, and that describe how the extent of available information on potential candidates will affect whether they are selected for prioritization. For example, in identifying potential candidates for High-Priority Substance designations, EPA is proposing to seek to identify chemical substances where available information suggests that the chemical substance may present a hazard and that exposure is present under ``one or more conditions of use,'' but where an ``unreasonable risk'' determination cannot be made without a more extensive or complete assessment in a risk evaluation. EPA interprets the statutory definition of a High-Priority Substance (``. . . may present an unreasonable risk [. . .] because of a potential hazard and a potential route of exposure . . .'') to set a fairly low bar, and EPA expects that a large number of chemical substances will meet this definition. Although EPA will prioritize a ``chemical substance'' as a whole, EPA may base its identification of a potential candidate as a High-Priority Substance, and ultimately the proposed designation, on a single condition of use, provided the hazard and exposure associated with that single use support such a designation. This proposal is based on the statutory definition of a High-Priority Substance, which is clear that the standard for the chemical as a whole can be met based on a single condition of use (``. . . because of a potential hazard and a potential route of exposure . . .''). Conversely, in identifying potential candidates for Low-Priority Substance designation, EPA is proposing that it will seek to identify chemical substances where the information indicates that hazard and exposure potential for ``all conditions of use'' are so low that EPA can confidently set that chemical substance aside without doing further evaluation. By comparison, then, TSCA's definition of Low-Priority Substance (``. . . based on sufficient information, such substance does not meet the standard for [. . .] a high-priority substance . . .'') is fairly rigorous, and effectively requires EPA to determine that under no condition of use does the chemical meet the High-Priority Substance standard. Consequently, EPA expects it will be more difficult to support such designations. Unlike High-Priority Substances, EPA will not be able to designate a chemical substance as a Low-Priority Substance without first looking at all of the conditions of use. While not determinative, EPA believes that its Safer Chemicals Ingredients List (SCIL) (Ref. 6) will be a good starting point for identifying potential candidates for Low-Priority Substance designations. EPA is also proposing to include the following list of additional exposure and hazard considerations that can be used to narrow the field of potential candidates: (1) Persistent, bioaccumulative, and toxic; (2) Used in children's products; (3) Used in consumer products; (4) Detected in human and/or ecological biomonitoring programs; (5) Potentially of concern for children's health; (6) High acute and chronic toxicity; (7) Probable or known carcinogen; (8) Neurotoxicity; or (9) Other emerging exposure and hazard concerns to human health or the environment, as determined by the Agency. These criteria are drawn from EPA's 2012 TSCA Work Plan methodology (Ref. 4), which, as discussed earlier, was the process EPA had been using to prioritize chemical substances for assessment under TSCA. EPA will evaluate one or more of these nine considerations, and chemical substances that meet one or more of these criteria may be identified as potential candidates for High-Priority Substance designations. For example, if a chemical substance is highly toxic and used in consumer products, EPA may wish to consider that chemical substance as a potential High-Priority Substance candidate. EPA may also choose to identify potential candidates based on other criteria that suggest the chemical substance may otherwise present a human health or environmental concern, as contemplated in the ``catch-all'' provision (9). The fact that a chemical substance meets one of these criteria is not determinative of an outcome, including whether or not EPA will select the chemical substance to go into the prioritization process and/or the priority designation that the chemical substance will ultimately receive. Conversely, chemical substances that meet none of these criteria may be good potential candidates for Low-Priority Substance designation. The considerations are intended to serve as a general guide for the Agency, based on EPA's current understanding of important considerations regarding [[Page 4831]] potential chemical risk. It should also be noted that while these considerations are drawn from EPA's 2012 Work Plan methodology (Ref. 4), EPA will apply them differently for prioritization. In the TSCA Work Plan context, only chemical substances that met these initial criteria were eligible for listing on Work Plan. For purposes of prioritization under TSCA, the considerations do not determine eligibility, but rather are designed to help EPA to narrow its focus. G. Information Availability Another key consideration in the pre-prioritization phase is the existence and availability of risk-related information on a candidate or potential candidate chemical substance. Because EPA must complete its prioritization process within 12 months once prioritization has been initiated for a chemical substance, immediately initiate a risk evaluation for High-Priority Substance, and complete the risk evaluation within three years of initiation, EPA cannot assume that it will be able to require the generation of critical information during these time frames. Furthermore, the statute does not grant EPA the discretion to significantly delay either of these processes, pending development of information. Consequently, prior to initiating the prioritization process for a chemical substance, EPA will generally review the available hazard and exposure-related information, and evaluate whether that information would be sufficient to allow EPA to complete both prioritization and risk evaluation processes. As part of such an evaluation, EPA expects to consider the quality, objectivity, utility, and integrity of the available information. To the extent the information is not currently available or is insufficient, EPA will determine whether or not information can be developed and collected, reviewed and incorporated into analyses and decisions in a timely manner. The proposed rule makes it clear that sufficiency of available information is likely to be a crucial factor in the selection of the chemical substances that EPA chooses to put into the prioritization process. As noted, if information gaps are identified during the prioritization or risk evaluation processes, EPA expects that it could be difficult to require the development of necessary chemical substance information, and receive, evaluate, and incorporate that information into analyses and decisions within the statutory timeframes. Tests necessary for risk evaluation, for example, could take months or years to develop and execute, plus additional time for EPA to issue the order or rule, and to collect, review and incorporate the new information. To avoid such a scenario, EPA believes that it will need to do a significant amount of upfront data gathering and review. This approach ensures that EPA stays on track to meet relevant statutory deadlines-- particularly those for risk evaluation. The proposed rule makes clear that EPA generally expects to use this new authority, as appropriate and necessary, to gather the requisite information prior to initiating prioritization. This could include, as appropriate, TSCA information collection, testing, and subpoena authorities, including those under TSCA sections 4, 8, and 11(c), to develop needed information. Given the importance of ensuring that sufficient information is available to conduct the prioritization and risk evaluation processes, EPA is proposing to include this consideration during the earliest stage in the process: During the identification of potential candidates. However, this criterion remains relevant even after EPA has selected a candidate and screened that chemical substance against the statutory criteria in TSCA section 6(b)(1)(A). Thus, if at any time prior to the publication of a notice in the Federal Register initiating prioritization, EPA determines that more information will be necessary to support a prioritization designation or a subsequent risk evaluation, EPA can choose not to initiate prioritization for that chemical substance pending development of additional information. H. Selection and Screening of a Candidate Chemical Substance As noted in Unit II., TSCA requires that EPA give preference to chemical substances listed in the 2014 update of the TSCA Work Plan for Chemical Assessments that (1) have a Persistence and Bioaccumulation Score of 3; and (2) are known human carcinogens and have high acute and chronic toxicity. TSCA section 6(b)(2)(B) further requires that 50 percent of all ongoing risk evaluations be drawn from the 2014 Update to the TSCA Work Plan for Chemical Assessments, meaning that EPA will need to draw at least 50 percent of High-Priority Substance candidates from the same list. By operation of the statute, TSCA requires that all TSCA Work Plan chemical substances eventually be prioritized. However, it is premature to presume that those chemical substances will necessarily be prioritized as High-Priority Substances, or that EPA would find unreasonable risk. Aside from these statutory preferences, however, TSCA does not limit how EPA must ultimately select a candidate chemical substance to put into the prioritization process. EPA is proposing that it will select a candidate--for either High-Priority Substances or Low-Priority Substance--based on the policy objectives described in Unit III.A. and the pre-prioritization considerations described in Unit III. F. and G. The development of the proposed rule, including these policy objectives, considerations and criteria, was informed by EPA's experience implementing the 2012 TSCA Work Plan methodology, which has been the Agency's primary tool for identifying candidate chemical substances for further assessment under TSCA. In addition, EPA fully recognizes the important role that stakeholders can play in helping the Agency to identify candidates for prioritization or to better understand the unique uses or characteristics of a particular chemical. EPA continues to welcome this type of engagement and dialogue early in the process, including during the pre-prioritization phase. While the proposed rule provides multiple opportunities for public feedback during the prioritization process, EPA is requesting comment on whether and how EPA should solicit additional input at the pre-prioritization phase. Further, given EPA's objective to avoid simply moving the market to substitute chemical substances of equal or greater risks, EPA requests comment on whether and how information on the availability of chemical substitutes should be taken into account during this phase of the prioritization process. Once a single candidate chemical substance (or category of chemical substances) is selected, EPA will screen the selected candidate against the specific criteria and considerations in TSCA section 6(b)(1)(A). Those criteria and considerations are: (1) The chemical substance's hazard and exposure potential; (2) the chemical substance's persistence and bioaccumulation; (3) potentially exposed or susceptible subpopulations; (4) storage of the chemical substance near significant sources of drinking water; (5) the chemical substance's conditions of use or significant changes in conditions of use; and (6) the chemical substance's production volume or significant changes in production volume. Because TSCA does not prohibit EPA from expanding the statutory screening criteria, the proposed rule also provides an additional criterion: (7) Any other risk-based criteria relevant to the [[Page 4832]] designation of the chemical substance's priority, in EPA's discretion. This final criterion allows the screening review to adapt with future changes in our understanding of science and chemical risks. In addition, EPA fully recognizes the important role that stakeholders can play in helping the Agency to identify candidates for prioritization or to better understand the unique uses or characteristics of a particular chemical. EPA continues to welcome this type of engagement and dialogue early in the process, including during the pre-prioritization phase. While the proposed rule provides multiple opportunities for public feedback during the prioritization process, EPA is requesting comment on whether and how EPA should solicit additional input at the pre- prioritization phase. The screening review is not a risk evaluation, but rather a review of available information on the chemical substance that relates to the screening criteria. EPA expects to evaluate all relevant sources of information while conducting the screening review, including, as appropriate, the hazard and exposure sources listed in Appendices A and B of the 2012 TSCA Work Plan methodology (Ref. 4). Ultimately, the screening review and other considerations during the pre-prioritization phase are meant to inform EPA's decisions on (1) whether to initiate the prioritization process on a particular chemical substance, and (2) once initiated, the proposed designation of that chemical substance as either a High-Priority Substances or Low-Priority Substance. I. Initiation of Prioritization The prioritization process officially begins, for purposes of triggering the nine to twelve month statutory timeframe, when EPA publishes a notice in the Federal Register identifying a chemical substance for prioritization. The proposed rule also specifies that EPA will publish the results of the screening review in the Federal Register, describing the information, analysis and basis used to conduct that review and providing in the docket copies of relevant information not otherwise protected as confidential business information under TSCA section 14. Publication of the notice in the Federal Register also initiates a 90-day public comment period. For each chemical substance, EPA will open a docket to facilitate receipt of public comments and access to publicly available information throughout this process. Interested persons can submit information regarding the results of the screening review or any other information relevant to the chemical substance. Of particular interest to EPA will be information related to ``conditions of use'' that are missing from the screening results. EPA will consider all relevant information received during this comment period. Consistent with TSCA section 6(b)(1)(C)(iii), the proposed rule further allows EPA to extend this initial public comment period for up to 3 months to receive and/or evaluate information developed from a test order, commensurate with EPA's need for additional time to receive and/or evaluate this information. As a practical matter, EPA is unlikely to often extend this initial public comment, given EPA's intention to ensure that all or most of the necessary information is available before initiating the prioritization process. Further, a three month window would not often provide a sufficient time to gather, let alone consider, new test data for the prioritization process. This is generally expected to be the case even with the authority to more quickly collect such information under the new test order authority in TSCA section 4. J. Proposed Priority Designation Based on the results of the screening review, relevant information received from the public in the initial comment period, and other information as appropriate, EPA will propose to designate the chemical substance as either a High-Priority Substance or Low-Priority Substance, as those terms are defined in TSCA. In making this proposed designation, as directed by the statute, EPA will not consider costs or other non-risk factors. This proposed rule provides that EPA will publish the proposed designation in the Federal Register, along with an identification of the information, analysis and basis used to support a proposed designation, in a form and manner that EPA deems appropriate, and provide a second comment period of 90 days, during which time the public may submit comments on EPA's proposed designation. EPA proposes to use the same docket for this step of the process. Because the supporting documentation for a proposed High-Priority Substance designation is likely to foreshadow what will go into a scoping document for risk evaluation, EPA will be particularly interested in early comments on the accuracy of scope-related information such as the chemical's ``conditions of use.'' In the event of insufficient information at the proposed designation step, EPA is proposing to designate a chemical substance as a High-Priority Substance. EPA expects this situation to occur infrequently based on its application of the criteria and considerations during the pre-prioritization phase. However, if for some reason the information available to EPA is insufficient to support a proposed designation of the chemical substance as a Low-Priority Substance, including after any extension of the initial public comment period, consistent with the statute, the proposed rule requires EPA to propose to designate the chemical substance as a High-Priority Substance. The statute requires that the prioritization process lead to one of two outcomes by the end of the 12-month deadline: A High- Priority Substance designation or a Low-Priority Substance designation. 15 U.S.C. 2605(b)(1)(B). There is no third option to allow EPA to either require the development of additional information or otherwise toll this deadline. Further, the statute specifically requires that a Low-Priority Substance designation be based on ``information sufficient to establish'' that a chemical substance meets the definition. 15 U.S.C. 2605(b)(1)(B)(ii). There is no comparable statutory requirement for High-Priority Substance designations. 15 U.S.C. 2605(b)(1)(B)(i). It is also relevant that the effect of designating a chemical as High- Priority Substance is that EPA further evaluates the chemical substance; by contrast, a Low-Priority Substance designation is a final Agency determination that no further evaluation is warranted--a determination that constitutes final agency action, subject to judicial review. 15 U.S.C. 2618(a)(1)(C)(i). The logical implication of this statutory structure is that scientific uncertainty in this process (including as a result of insufficient information) is to weigh in favor of a High-Priority Substance designation, as it is merely an interim step that ensures that the chemical will be further evaluated. EPA's proposal would also ensure that this process would not create any incentives for parties to withhold readily available information, or inadvertently discourage the voluntary generation of data, as could occur were EPA to establish, for example, a default designation to Low-Priority. As a practical matter, however, EPA expects this situation to occur infrequently, based on its proposed criteria and considerations that will generally ensure that sufficient information is available to conduct a risk evaluation before initiating prioritization. Priority designations, whether they were based on sufficient information or a lack of sufficient information, are neither an [[Page 4833]] affirmation of risk nor safety. EPA therefore recognizes that all priority designations will need to be carefully communicated to the public. For proposed designations as Low-Priority Substances, EPA is proposing to require that all comments that could be raised on the issues in the proposed designation must be presented during the comment period. Any issues not raised will be considered to have been waived, and may not form the basis for an objection or challenge in any subsequent administrative or judicial proceeding. This is a well- established principle of administrative law and practice, e.g., Nuclear Energy Institute v. EPA, 373 F.3d 1251, 1290-1291 (D.C. Cir. 2004), and the need for such a provision is reinforced by the statutory deadlines under which EPA must operate here. EPA is restricting this to Low- Priority Substance designations, as it is the last opportunity for public input before EPA's action becomes final, and thus it is imperative that any issues are shared during this public comment period. By contrast, designation of a chemical substance as a High- Priority Substance is not final agency action. The statute mandates additional opportunities for public input during the risk evaluation process, and EPA does not consider it appropriate to restrict the public's ability to comment during these subsequent processes based on this early phase proceeding. K. Final Priority Designation After considering any additional information collected during the proposed designation step, as appropriate, the last step in the prioritization process is for EPA to finalize its designation of a chemical substance as either a High-Priority Substance or a Low- Priority Substance. The proposed rule specifies that EPA will publish the priority designation in the Federal Register, and will use the same docket. Again, TSCA prohibits costs or other non-risk factors from being considered in this designation. And, as with the proposed designation step, if information available to EPA remains insufficient to support the final designation of the chemical substance as a Low- Priority Substance, EPA will finalize the designation as a High- Priority Substance. Although final High-Priority designations based on insufficient information are unlikely for all the reasons described in Unit III.J., such a designation would require EPA to conduct a risk evaluation on that substance, and to support the risk evaluation with adequate information. EPA would need to develop or require development of the necessary information and complete the risk evaluation within the 3-year statutory deadline. L. Repopulation of High-Priority Substances TSCA requires EPA to finalize a designation for at least one new High-Priority Substance upon completion of a risk evaluation for another chemical substance, other than a risk evaluation that was requested by a manufacturer. Because the timing for the completion of risk evaluation and/or the prioritization process will be difficult to predict, EPA intends to satisfy this 1-off-1-on replacement obligation as follows: In the notice published in the Federal Register finalizing the designation of a new High-Priority Substance, EPA will identify the complete or near-complete risk evaluation that the new High-Priority Substance will replace. So long as the designation occurs within a reasonable time before or after the completion of the risk evaluation, this will satisfy Congress' intent while avoiding unnecessary delay and the logistical challenges that would be associated with more perfectly aligning a High-Priority Substance designation with the completion of a risk evaluation. M. Effect of Final Priority Designation Final designation of a chemical substance as a High-Priority Substance requires EPA to immediately begin a risk evaluation on that chemical substance. It is important to note that High-Priority Substance designation does not mean that the Agency has determined that the chemical substance presents a risk to human health or the environment--only that the Agency intends to consider the chemical substance for further risk review and evaluation. A High-Priority Substance designation is not a final agency action and is not subject to judicial review or review under the Congressional Review Act (CRA), 5 U.S.C. 801 et seq. Final designation of a chemical substance as a Low-Priority Substance means that a risk evaluation of the chemical substance is not warranted at the time, but does not preclude EPA from later revising the designation, if warranted. Notably, a Low-Priority Substance designation is explicitly subject to judicial review. 15 U.S.C. 2618(a)(1)(C). N. Revision of Designation TSCA provides that EPA may revise a final designation of a chemical substance from a Low-Priority Substance to a High-Priority Substance at any time based on information available to the Agency. The proposed rule outlines the process the Agency will take to revise such a designation. Specifically, EPA would (1) re-screen the chemical substance incorporating the relevant information, (2) re-initiate the prioritization process and take public comment, (3) re-propose a priority designation and take public comment, and (4) re-finalize the priority designation. EPA will not revise a final designation of a chemical substance from High-Priority Substance to Low-Priority Substance, but rather see the risk evaluation process through to its conclusion. IV. References The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT. 1. EPA. TSCA Work Plan for Chemical Assessments: 2014 Update. October 2014. Available online at: https://www.epa.gov/sites/production/files/2015-01/documents/tsca_work_plan_chemicals_2014_update-final.pdf. 2. EPA. Framework for Metals Risk Assessment. EPA 120/R-07/001. March 2007. Available online at: https://www.epa.gov/sites/production/files/2013-09/documents/metals-risk-assessment-final.pdf. 3. EPA. Science Policy Council Handbook: Risk Characterization. EPA/ 100/B-00/002. December 2000. Available online at: https://www.epa.gov/risk/risk-characterization-handbook. 4. EPA. TSCA Work Plan Chemicals: Methods Document. February 2012. Available online at: https://www.epa.gov/sites/production/files/2014-03/documents/work_plan_methods_document_web_final.pdf. 5. EPA. 2012 TSCA Work Plan Chemicals. June 2012. Available online at: https://www.epa.gov/sites/production/files/2014-02/documents/work_plan_chemicals_web_final.pdf. 6. EPA. Safer Chemical Ingredients List (SCIL). Available online at: https://www.epa.gov/saferchoice/safer-ingredients. See also Master Criteria, September 2012, Version 2.1, available online at: https://www.epa.gov/sites/production/files/2013-12/documents/dfe_master_criteria_safer_ingredients_v2_1.pdf. V. Statutory and Executive Order Reviews Additional information about these statutes and Executive Orders can be [[Page 4834]] found at http://www2.epa.gov/laws-regulations/laws-and-executive-orders. A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket. B. Paperwork Reduction Act (PRA) This action does not contain any information collection activities that require approval under the PRA, 44 U.S.C. 3501 et seq. This rulemaking addresses internal EPA operations and procedures and does not impose any requirements on the public. C. Regulatory Flexibility Act (RFA) I certify under section 605(b) of the RFA, 5 U.S.C. 601 et seq., that this action will not have a significant economic impact on a substantial number of small entities. This rulemaking addresses internal EPA operations and procedures and does not impose any requirements on the public, including small entities. D. Unfunded Mandates Reform Act (UMRA) This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. E. Executive Order 13132: Federalism This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Thus, Executive Order 13175 does not apply to this action. G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of ``covered regulatory action'' in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. H. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use This action is not a ``significant energy action'' as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. This rulemaking addresses internal EPA operations and procedures and does not impose any requirements on the public. I. National Technology Transfer and Advancement Act (NTTAA) This rulemaking does not involve any technical standards, and is therefore not subject to considerations under NTTAA section 12(d), 15 U.S.C. 272 note. J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations This action does not establish an environmental health or safety standard, and is therefore not is not subject to environmental justice considerations under Executive Order 12898 (59 FR 7629, February 16, 1994). This rulemaking addresses internal EPA operations and procedures and does not have any impact on human health or the environment. List of Subjects in 40 CFR Part 702 Environmental protection, Chemicals, Chemical substances, Hazardous substances, Health and safety, Prioritization, Screening, Toxic substances. Dated: December 27, 2016 Gina McCarthy, Administrator. Therefore, 40 CFR chapter I, subchapter R, is proposed to be amended as follows: PART 702--[AMENDED] 0 1. The authority citation for part 702 is revised to read as follows: Authority: 15 U.S.C. 2605 and 2619. 0 2. Add subpart A to read as follows: PART 702--GENERAL PRACTICES AND PROCEDURES Subpart A--Procedures for Prioritization of Chemical Substances for Risk Evaluation 702.1 General Provisions. 702.3 Definitions. 702.5 Considerations for Potential Candidates for Prioritization. 702.7 Candidate Selection and Screening Review. 702.9 Initiation of Prioritization Process. 702.11 Proposed Priority Designation. 702.13 FinaL Priority Designation. 702.15 Revision of Designation. 702.17 Effect of Designation as a Low-Priority Substance. 702.19 Effect of Designation as a High-Priority Substance. * * * * * Authority: 15 U.S.C. 2605 and 2619. Subpart A--Procedures for Prioritization of Chemical Substances for Risk Evaluation Sec. 702.1 General Provisions. (a) Purpose. This regulation establishes the risk-based screening process for designating chemical substances as a High-Priority Substance or a Low-Priority Substance for risk evaluation as required under section 6(b) of the Toxic Substances Control Act, as amended (15 U.S.C. 2605(b)). (b) Scope of designations. EPA will make priority designations pursuant to these procedures for a chemical substance, not for a specific condition or conditions of use of a chemical substance. (c) Categories of chemical substances. Nothing in this subpart shall be interpreted as a limitation on EPA's authority under 15 U.S.C. 2625(c) to take action, including the actions contemplated in this subpart, on a category of chemical substances. (d) Prioritization timeframe. The Agency will publish a final priority designation for a chemical substance in no fewer than 9 months and no longer than 1 year following initiation of prioritization pursuant to 40 CFR 702.9. (e) Metals or metal compounds. In identifying priorities for chemical [[Page 4835]] substances that are metals or metal compounds, EPA will, as appropriate, refer to relevant considerations from the Framework for Metals Assessment of the Office of the Science Advisor, Risk Assessment Forum, dated March 2007, or a successor document that addresses metals risk assessment and is peer reviewed by the Science Advisory Board. (f) Applicability. These regulations do not apply to any chemical substance for which a manufacturer requests a risk evaluation under TSCA section 6(b)(4)(C) (15 U.S.C. 2605(b)(4)(C)). Sec. 702.3 Definitions. For purposes of this subpart, the following definitions apply: Act means the Toxic Substances Control Act, as amended (15 U.S.C. 2601 et seq.) EPA means the U.S. Environmental Protection Agency. High-Priority Substance means a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA. Low-Priority Substance means a chemical substance that EPA concludes, based on information sufficient to establish, without consideration of costs or other non-risk factors, does not meet the standard for a High-Priority Substance. Sec. 702.5 Consideration of Potential Candidates for Prioritization. (a) Potential High-Priority Substance Candidates. In identifying potential candidates for High-Priority Substances, EPA will generally consider whether information available to the Agency suggests there is hazard and exposure under a condition or conditions of use, and whether a risk evaluation would be needed to determine whether there is an unreasonable risk of injury to health or the environment. (b) Potential Low-Priority Substance Candidates. In identifying potential candidates for Low-Priority Substances, EPA will generally consider whether information available to the EPA suggests such low hazard and/or exposure under all conditions of use that EPA is confident the chemical substances does not present an unreasonable risk of injury to health or the environment, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA, even in the absence of a risk evaluation. (c) Exposure and Hazard Considerations for Potential Candidates. In identifying potential candidates for prioritization, EPA will generally evaluate whether or not the chemical substance meets one or more of the following exposure or hazard considerations: (1) Persistent, bioaccumulative, and toxic; (2) Used in children's products; (3) Used in consumer products; (4) Detected in human and/or ecological biomonitoring programs; (5) Potentially of concern for children's health; (6) High acute and chronic toxicity; (7) Probable or known carcinogen; (8) Neurotoxicity; or (9) Other emerging exposure and hazard concerns to human health or the environment, as determined by the Agency. A chemical substance that meets one or more of these criteria will generally be considered as a potential candidate for further consideration as a High-Priority Substance. A chemical substance that meets none of these criteria will generally be considered as a potential candidate for further consideration as a Low-Priority Substance. (d) Available Information and Resources. EPA expects it will often be difficult to timely require development of necessary chemical information, and receive, evaluate, and incorporate that information into analyses, during the prioritization and risk evaluation processes, within the statutory deadlines under the Act for prioritization and risk evaluation at 15 U.S.C. 2605 (b)(1)(C) and (b)(4)(G). Therefore, EPA will generally review and analyze the information necessary for both prioritization and risk evaluation prior to initiating the prioritization process for a chemical substance pursuant to 40 CFR 702.9. Specifically, in identifying potential candidates for prioritization, EPA expects to consider: (1) The availability of information and resources necessary and sufficient to support a priority designation pursuant to 40 CFR 702.11, a risk evaluation pursuant to 40 CFR 702, subpart B, or other such action as determined by the Administrator; and (2) The ability of EPA to timely develop or require development of information necessary and sufficient to support a priority designation pursuant to 40 CFR 702.11; a risk evaluation pursuant to 40 CFR 702, subpart B; or other such action as determined by the Agency. (e) Insufficient Information. In the absence of sufficient information to support a priority designation pursuant to 40 CFR 702.11, a risk evaluation pursuant to 40 CFR 702, subpart B, or other such action as determined by the Agency, EPA may use its authorities under the Act, and other information gathering authorities, to gather or require the generation of the needed information on a chemical substance before initiating the prioritization process for that chemical substance. Sec. 702.7 Candidate Selection and Screening Review. (a) Preferences and TSCA Work Plan. In selecting a candidate for prioritization as a High-Priority Substance, EPA will: (1) Give preference to: (A) Chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments as having a persistence and bioaccumulation score of 3, and (B) Chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments that are known human carcinogens and have high acute and chronic toxicity; and (2) Identify a sufficient number of candidates from the 2014 update of the TSCA Work Plan for Chemical Assessments to ensure that, at any given time, at least 50 percent of risk evaluations being conducted by EPA are drawn from that list until all substances on the list have been designated as either a High-Priority Substance or Low-Priority Substance pursuant to 40 CFR 702.13. (b) General Objective. In selecting candidates for a High-Priority Substance designation, it is EPA's general objective to select those chemical substances with the greatest hazard and exposure potential first, considering available information on the relative hazard and exposure of potential candidates. EPA may also consider the relative hazard and exposure of a potential candidate's substitutes. EPA is not required to select candidates or initiate prioritization pursuant to 40 CFR 702.9 in any ranked or hierarchical order. (c) Screening Review. Following selection of a candidate chemical substance, EPA will generally use available information to screen the candidate chemical substance against the following criteria and considerations: (1) The chemical substance's hazard and exposure potential; [[Page 4836]] (2) The chemical substance's persistence and bioaccumulation; (3) Potentially exposed or susceptible subpopulations; (4) Storage of the chemical substance near significant sources of drinking water; (5) The chemical substance's conditions of use or significant changes in conditions of use; (6) The chemical substance's production volume or significant changes in production volume; and (7) Any other risk-based criteria relevant to the designation of the chemical substance's priority, in EPA's discretion. (d) Information sources. In conducting the screening review in paragraph (c) of this section, EPA expects to consider sources of information relevant to the listed criteria, including, as appropriate, sources for hazard and exposure data listed in Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012). (e) The purpose of the preferences and criteria in paragraph (a) of this section and the screening review in paragraph (c) of this section are to inform EPA's decision whether or not to initiate the prioritization process pursuant to 40 CFR 702.9, and the proposed designation of the chemical substance as either a High-Priority Substance or a Low-Priority Substance pursuant to 40 CFR 702.11. (f) If, after the screening review in paragraph (c) of this section, EPA believes it will not have sufficient information to support a proposed priority designation pursuant to 40 CFR 702.11, a risk evaluation pursuant to 40 CFR 702, subpart B, or other such action as determined by the Agency, EPA is likely to use its authorities under the Act, and other information gathering authorities, to generate the needed information before initiating prioritization pursuant to 40 CFR 702.9. Sec. 702.9 Initiation of Prioritization Process. (a) EPA generally expects to initiate the prioritization process for a chemical substance only when it believes that all or most of the information necessary to prioritize and perform a risk evaluation on the substance already exists. (b) EPA will initiate prioritization by publishing a notice in the Federal Register identifying a chemical substance for prioritization and the results of the screening review conducted pursuant to 40 CFR 702.7(c). (c) The prioritization timeframe in 40 CFR 702.1(d) begins upon EPA's publication of the notice described in paragraph (b) of this section. (d) The results of the screening review published pursuant to paragraph (b) of this section will identify, in a form and manner that EPA deems appropriate, the information analysis and basis used in conducting the screening process. Subject to 15 U.S.C. 2613, copies of the information will also be placed in a public docket established for each chemical substance. (e) Publication of a notice in the Federal Register pursuant to paragraph (b) of this section will initiate a period of 90 days during which interested persons may submit relevant information on that chemical substance. Relevant information might include, but is not limited to, any information regarding the results of the screening review conducted pursuant to 40 CFR 702.7(c), and any additional information on the chemical substance that pertains to the criteria and considerations at 40 CFR 702.7(c). (f) EPA may, in its discretion, extend the public comment period in paragraph (b) of this section for up to three months in order to receive or evaluate information submitted under 15 U.S.C. 2603(a)(2)(B). The length of the extension will be based upon EPA's assessment of the time necessary for EPA to receive and/or evaluate information submitted under 15 U.S.C. 2603(a)(2)(B). Sec. 702.11 Proposed Priority Designation. (a) Based on the results of the screening review in 40 CFR 702.7(c), relevant information received from the public as described in 40 CFR 702.9(e), and other information as appropriate and in EPA's discretion, EPA will propose to designate the chemical substance as either a High-Priority Substance or Low-Priority Substance. (b) EPA will not consider costs or other non-risk factors in making a proposed priority designation. (c) If information available to EPA remains insufficient to enable the proposed designation of the chemical substance as a Low-Priority Substance, including after any extension of the initial public comment period pursuant to 40 CFR 702.9(f), EPA will propose to designate the chemical substance as a High-Priority Substance. (d) EPA may propose to designate a chemical substance as a High- Priority Substance based on the proposed conclusion that the chemical substance satisfies the definition of High-Priority Substance in 40 CFR 702.3 under any one or more uses that the Agency determines constitute conditions of use as defined in 15 U.S.C. 2602. EPA will propose to designate a chemical substance as a Low-Priority Substance based only on the proposed conclusion that the chemical substance satisfies the definition of Low-Priority Substance in 40 CFR 702.3 under all uses that the Agency determines constitute conditions of use as defined in 15 U.S.C. 2602. (e) EPA will publish the proposed designation in the Federal Register, along with an identification of the information, analysis and basis used to support a proposed designation, in a form and manner that EPA deems appropriate, and provide a comment period of 90 days, during which time the public may submit comment on EPA's proposed designation. EPA will open a docket to facilitate receipt of public comment. (f) For chemical substances that EPA proposes to designate as Low- Priority Substances, EPA will specify in the notice published pursuant to paragraph (e) of this section that all comments that could be raised on the issues in the proposed designation must be presented during this comment period. Any issues not raised at this time will be considered to have been waived, and may not form the basis for an objection or challenge in any subsequent administrative or judicial proceeding. Sec. 702.13 Final Priority Designation. (a) After considering any additional information collected from the proposed designation process in 40 CFR 702.11, as appropriate, EPA will finalize its designation of a chemical substance as either a High- Priority Substance or a Low-Priority Substance. (b) EPA will not consider costs or other non-risk factors in making a final priority designation. (c) EPA will publish each final priority designation in the Federal Register. (d) EPA will finalize a designation for at least one High-Priority Substance for each risk evaluation it completes, other than a risk evaluation that was requested by a manufacturer pursuant to 40 CFR 702, subpart B. The obligation in 15 U.S.C. 2605(b)(3)(C) will be satisfied by the designation of at least one High-Priority Substance where such designation specifies the risk evaluation that the designation corresponds to, and where the designation occurs within a reasonable time before or after the completion of the risk evaluation. (e) If information available to EPA remains insufficient to enable the final designation of the chemical substance as a Low-Priority Substance, EPA will finalize the designation of the chemical substance as a High-Priority Substance. [[Page 4837]] Sec. 702.15 Revision of Designation. EPA may revise a final designation of chemical substance from Low- Priority to High-Priority Substance at any time based on information available to the Agency. To revise such a designation, EPA will re- screen the chemical substance pursuant to 40 CFR 702.7(c), re-initiate the prioritization process on that chemical substance in accordance with 40 CFR 702.9, propose a priority designation pursuant to 40 CFR 702.11, and finalize the priority designation pursuant to 40 CFR 702.13. EPA will not revise a final designation of a chemical substance from a High-Priority Substance designation to Low-Priority. Sec. 702.17 Effect of Designation as a Low-Priority Substance. Designation of a chemical substance as a Low-Priority Substance under 40 CFR 702.3 means that a risk evaluation of the chemical substance is not warranted at the time, but does not preclude EPA from later revising the designation pursuant to 40 CFR 702.15, if warranted. Sec. 702.19 Effect of Designation as a High-Priority Substance. Final designation of a chemical substance as a High-Priority Substance under 40 CFR 702.13 initiates a risk evaluation pursuant to 40 CFR 702, subpart B. Designation as a High-Priority Substance is not a final agency action and is not subject to judicial review. * * * * * [FR Doc. 2017-00051 Filed 1-13-17; 8:45 am] BILLING CODE 6560-50-P
![Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules 4825
Water Act and 40 CFR part 143, subpart ACTION: Proposed rule. SUPPLEMENTARY INFORMATION:
B; and
SUMMARY: As required under section I. Executive Summary
(5) The signature, date, name and
position of the signatory; and if the 6(b)(1) of the Toxic Substances Control A. Does this action apply to me?
signatory is an authorized representative Act (TSCA), EPA is proposing to
establish a risk-based screening process This proposed rule does not propose
of a responsible corporate officer, a to establish any requirements on
general partner or proprietor, the name and criteria that EPA will use to identify
chemical substances as either High- persons or entities outside of the
and position of the responsible Agency. This action may, however, be of
corporate officer, a general partner or Priority Substances for risk evaluation,
or Low-Priority Substances for which interest to entities that are or may
proprietor. manufacture or import a chemical
(f) Manufacturers or importers that risk evaluations are not warranted at the
substance regulated under TSCA (e.g.,
self-certify products must maintain, at a time. The proposed rule describes the
entities identified under North
primary place of business within the processes for identifying potential
American Industrial Classification
United States, certificates of conformity candidates for prioritization, selecting a
System (NAICS) codes 325 and 324110).
and sufficient documentation to confirm candidate, screening that candidate
Since other entities may also be
that products meet the lead free against certain criteria, formally
interested, the Agency has not
requirements of this subpart. Sufficient initiating the prioritization process,
attempted to describe all the specific
documentation may include: Detailed providing opportunities for public
entities and corresponding NAICS codes
schematic drawings of the products comment, and proposing and finalizing
for entities that may be interested in or
indicating dimensions, calculations of designations of priority. Prioritization is
affected by this action.
the weighted average lead content of the the initial step in a new process of
product, lead content of materials used existing chemical substance review and B. What action is the agency taking?
in manufacture and other risk management activity established EPA is proposing to establish the
documentation used in verifying the under recent amendments to TSCA. internal processes and criteria by which
lead content of a plumbing device. This DATES: Comments must be received on EPA will identify chemical substances
documentation and certificates of or before March 20, 2017. as either High-Priority Substances for
conformity must be provided upon ADDRESSES: Submit your comments, risk evaluation, or Low-Priority
request to the Administrator as specified identified by docket identification (ID) Substances for which risk evaluations
in § 143.20(b). number EPA–HQ–OPPT–2016–0636, by are not warranted at the time.
(g) The certificate of conformity and one of the following methods:
C. Why is the agency taking this action?
documentation must be completed prior • Federal eRulemaking Portal: http://
to a product’s introduction into www.regulations.gov. Follow the online This rulemaking is required by TSCA
commerce. instructions for submitting comments. section 6(b)(1)(A). Prioritization of
Do not submit electronically any chemical substances for further
§ 143.20 Compliance provisions. information you consider to be evaluation will ensure that the Agency’s
(a) Noncompliance with the Safe Confidential Business Information (CBI) limited resources are conserved for
Drinking Water Act or this subpart may or other information whose disclosure is those chemical substances most likely to
be subject to enforcement. Enforcement restricted by statute. present risks, thereby furthering EPA’s
actions may include seeking injunctive • Mail: Document Control Office overall mission to protect health and the
relief, civil or criminal penalties. (7407M), Office of Pollution Prevention environment.
(b) The Administrator may, on a case- and Toxics (OPPT), Environmental D. What is the agency’s authority for
by-case basis, request any information Protection Agency, 1200 Pennsylvania taking this action?
deemed necessary to determine whether Ave. NW., Washington, DC 20460–0001.
a person has acted or is acting in • Hand Delivery: To make special EPA is proposing this rule pursuant to
compliance with section 1417 of the arrangements for hand delivery or the authority in TSCA section 6(b), 15
Safe Drinking Water Act and this delivery of boxed information, please U.S.C. 2605(b). See also the discussion
subpart. Such information requested follow the instructions at http:// in Units II.A and B.
must be provided to the Administrator www.epa.gov/dockets/contacts.html. E. What are the estimated incremental
at a time and in a format as may be Additional instructions on commenting impacts of this action?
reasonably determined by the or visiting the docket, along with more
Administrator. This is a proposed rule that would
information about dockets generally, is
establish the processes by which EPA
[FR Doc. 2017–00743 Filed 1–13–17; 8:45 am] available at http://www.epa.gov/
intends to designate chemical
BILLING CODE 6560–50–P dockets.
substances as either High or Low-
FOR FURTHER INFORMATION CONTACT: Priority Substances for risk evaluation.
For technical information contact: It would not establish any requirements
ENVIRONMENTAL PROTECTION Ryan Schmit, Immediate Office, Office on persons or entities outside of the
AGENCY of Chemical Safety and Pollution Agency. EPA did not, therefore, estimate
Prevention, Environmental Protection potential incremental impacts from this
40 CFR Part 702
Agency, 1200 Pennsylvania Ave. NW., action.
[EPA–HQ–OPPT–2016–0636; FRL–9957–74] Washington, DC 20460–0001; telephone
sradovich on DSK3GMQ082PROD with PROPOSALS
number: (202) 564–0610; email address: F. What should I consider as I prepare
RIN 2070–AK23
schmit.ryan@epa.gov. my comments for EPA?
Procedures for Prioritization of For general information contact: The 1. Submitting CBI. Do not submit this
Chemicals for Risk Evaluation Under TSCA-Hotline, ABVI-Goodwill, 422 information to EPA through
the Toxic Substances Control Act South Clinton Ave., Rochester, NY regulations.gov or email. Clearly mark
14620; telephone number: (202) 554– the part or all of the information that
AGENCY: Environmental Protection 1404; email address: TSCA-Hotline@ you claim to be CBI. For CBI
Agency (EPA). epa.gov. information in a disk or CD–ROM that
VerDate Sep<11>2014 17:33 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00028 Fmt 4702 Sfmt 4702 E:\FR\FM\17JAP1.SGM 17JAP1](https://thefederalregister.org/doc/82_FR_4835/page/1.svg)
![4828 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
requirements on EPA in a number of While EPA is seeking public comment for completing risk assessments or
different areas that EPA is not proposing on all aspects of this proposed rule, the addressing identified risks.
to incorporate or otherwise address in Agency is specifically requesting public Prioritization under this proposed rule
this proposed rule. For example, input on this issue. The Agency will involve a similar culling, but upon
amendments to TSCA section 4 require welcomes public comments regarding designating a chemical substance as a
EPA to ‘‘. . . reduce and replace, to the the pros and cons of codifying these or High-Priority Substance, the Agency
extent practicable, [. . .] the use of other definitions and/or approaches for must start a risk evaluation, and
vertebrate animals in the testing of these or any other terms. EPA generally complete that evaluation
chemical substances . . .’’ and to encourages commenters to suggest within a specified amount of time. If
develop a strategic plan to promote such alternative definitions the Agency EPA determines in the risk evaluation
alternative test methods. 15 U.S.C. should consider for codification in this that a chemical substance presents an
2603(h). Likewise, TSCA section 26 procedural rule. Please explain your unreasonable risk of injury to health or
requires, to the extent that EPA makes views as clearly as possible, providing the environment, EPA must also initiate
a decision based on science under TSCA specific examples to illustrate your a risk management rulemaking subject
sections 4, 5, or 6, that EPA use certain concerns and suggest alternate wording, to statutory deadlines. 15 U.S.C.
scientific standards and base those where applicable. 2605(c). As such, EPA will need to be
decisions on the weight of the scientific judicious in selecting the chemical
C. Prioritization Under the 2012 TSCA
evidence. 15 U.S.C. 2625(h) and (i). substances that go into prioritization.
Work Plan Methodology Further, while chemical substances
While these requirements are relevant to
the prioritization of chemical Prioritization of chemical substances listed on the TSCA Work Plan were
substances, EPA is not obliged to for review is not a novel concept for the likely to be well-characterized for
include them in this proposed rule. By Agency. In 2012, EPA released the hazard and have at least some
their express terms, these statutory TSCA Work Plan Chemicals: Methods information indicating potential
requirements apply to EPA’s decisions Document in which EPA described the exposure, Work Plan chemical
under TSCA section 6, without the need process the Agency intended to use to substance assessments have generally
for regulatory action. Moreover, in identify potential candidate chemical focused on specific chemical uses.
contrast to TSCA section 6, Congress substances for near-term review and Given the statutory deadlines, EPA
has not directed EPA to implement assessment under TSCA (Ref. 4). EPA generally intends to ensure it has a more
these other requirements ‘‘by rule;’’ it is also published an initial list of TSCA complete set of data upfront that would
well-established that where Congress Work Plan chemicals identified for allow EPA to evaluate a chemical
has declined to require rulemaking, the further assessment under TSCA as part substance under all conditions of use (a
implementing agency has complete of its chemical safety program in 2012 broader scope) within the statutory
discretion to determine the appropriate (Ref. 5), and an updated list of chemical deadlines. For chemical substances with
method by which to implement those substances for further assessment in insufficient information to conduct a
provisions. E.g., United States v. Storer 2014 (Ref. 1). The process for risk evaluation, EPA generally expects
Broadcasting Co., 351 U.S. 192 (1956). identifying these chemical substances to pursue a significant amount of data
A number of stakeholders raised was based on a combination of hazard, gathering before initiating prioritization.
questions as to whether EPA should exposure, and persistence and Finally, the TSCA Work Plan process
define a number of important terms in bioaccumulation characteristics. focused solely on identifying potential
this rule (e.g., ‘‘best available science’’, Congress expressly recognized the high risk chemical substances for
‘‘weight-of-the-evidence’’, ‘‘sufficiency validity of EPA’s existing prioritization further review. Because the statute also
of information’’, ‘‘unreasonable risk’’, methodology for the TSCA Work Plan. requires the identification of Low-
and ‘‘reasonably available For example, the law requires that EPA Priority Substances—those chemical
information’’). Many of the terms used give certain preferences to chemical substances that EPA has determined,
in the proposed rule are not novel substances listed on the 2014 Update to based on sufficient evidence, do not
concepts and are already in use, and the TSCA Work Plan. 15 U.S.C. warrant further review at the time—EPA
their meaning is discussed extensively 2605(b)(2)(D). Moreover, the law will need to undertake new and
in existing Agency guidance. For requires that at least 50 percent of all different analyses than it has done to
example, extensive descriptions for the ongoing risk evaluations be drawn from date under the TSCA Work Plan.
phrases ‘‘best available science’’, the 2014 Update to the TSCA Work While EPA has drawn from the TSCA
‘‘weight-of-the-evidence’’, and Plan. 15 U.S.C. 2605(b)(2)(B). The Work Plan methodology and EPA’s
‘‘sufficiency of information’’ can be statutory screening criteria in TSCA experience in implementing that
found in EPA’s Risk Characterization section 6(b)(1)(A) also significantly process in developing this proposed
Handbook (Ref. 3), and in other existing overlaps with the considerations in the rule, EPA is proposing to tailor the
Agency guidance. Work Plan methodology (e.g., process for prioritization to the specific
EPA believes further defining these persistence, bioaccumulation, toxicity, requirements in the new statute.
and other terms in the proposed rule is carcinogenicity, etc.).
unnecessary and ultimately However, there are a number of key D. Stakeholder Involvement
problematic. These terms have and will differences between EPA’s TSCA Work On August 10, 2016, EPA held a one
continue to evolve with changing Plan process and the prioritization day public meeting to hear from
scientific methods and innovation. process that TSCA now requires. First, stakeholders to better understand their
sradovich on DSK3GMQ082PROD with PROPOSALS
Codifying specific definitions for these the Work Plan process involved culling viewpoints on the development of the
phrases in this rule may inhibit the through thousands of chemical prioritization rule. The meeting began
flexibility and responsiveness of the substances to create a list that EPA with a presentation from EPA on how
Agency to quickly adapt to and could, over time and without prescribed the Agency has prioritized chemicals for
implement changing science. The deadlines, focus its limited resources further review under the TSCA Work
Agency intends to use existing guidance on. The TSCA Work Plan did not Plan methodology. The remainder of the
definitions and to update definitions require EPA to assess listed chemical day was reserved for public comment.
and guidance as necessary. substances, and included no deadlines Commenters had approximately four
VerDate Sep<11>2014 17:33 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00031 Fmt 4702 Sfmt 4702 E:\FR\FM\17JAP1.SGM 17JAP1](https://thefederalregister.org/doc/82_FR_4835/page/4.svg)
![4830 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
D. Categories of Chemical Substances leaves EPA with broad discretion to Consequently, EPA expects it will be
TSCA section 26 provides EPA with choose which chemical substance to put more difficult to support such
authority to take action on categories of into that process. Accordingly, this designations. Unlike High-Priority
chemical substances. 15 U.S.C. 2625(c). proposed rule includes a discussion of Substances, EPA will not be able to
‘‘Category of Chemical Substances’’ is the criteria EPA expects to use to cull designate a chemical substance as a
through the chemical substances on the Low-Priority Substance without first
defined at 15 U.S.C. 2625(c)(2)(A).
TSCA Inventory. These include criteria looking at all of the conditions of use.
Although the proposed rule most often
that will be used to identify potential While not determinative, EPA believes
references ‘‘chemical substances,’’ EPA
candidates for High-Priority Substances that its Safer Chemicals Ingredients List
is also proposing to include a clear
or Low-Priority Substances, and that (SCIL) (Ref. 6) will be a good starting
statement in the regulation that nothing
describe how the extent of available point for identifying potential
in the proposed rule shall be construed
information on potential candidates will candidates for Low-Priority Substance
as a limitation on EPA’s authority to
affect whether they are selected for designations.
take action with respect to categories of
prioritization. EPA is also proposing to include the
chemical substances, and that, where For example, in identifying potential
appropriate, EPA can prioritize and following list of additional exposure
candidates for High-Priority Substance and hazard considerations that can be
evaluate categories of chemical designations, EPA is proposing to seek
substances. used to narrow the field of potential
to identify chemical substances where candidates: (1) Persistent,
E. Chemicals Subject to Prioritization available information suggests that the bioaccumulative, and toxic; (2) Used in
chemical substance may present a
Generally, all chemical substances children’s products; (3) Used in
hazard and that exposure is present
listed on the TSCA Inventory are subject consumer products; (4) Detected in
under ‘‘one or more conditions of use,’’
to prioritization. TSCA contemplates human and/or ecological biomonitoring
but where an ‘‘unreasonable risk’’
that, over time, all chemical substances programs; (5) Potentially of concern for
determination cannot be made without
on the TSCA Inventory will be children’s health; (6) High acute and
a more extensive or complete
prioritized into either High- or Low- chronic toxicity; (7) Probable or known
assessment in a risk evaluation. EPA
Priority Substances, and that all High- carcinogen; (8) Neurotoxicity; or (9)
interprets the statutory definition of a
Priority Substances will be evaluated. Other emerging exposure and hazard
High-Priority Substance (‘‘. . . may
EPA notes that chemical substances concerns to human health or the
present an unreasonable risk [. . .]
newly added to the TSCA Inventory because of a potential hazard and a environment, as determined by the
following EPA’s completion of pre- potential route of exposure . . .’’) to set Agency. These criteria are drawn from
manufacture review under section 5 of a fairly low bar, and EPA expects that EPA’s 2012 TSCA Work Plan
TSCA (15 U.S.C. 2604) are also a large number of chemical substances methodology (Ref. 4), which, as
candidates for prioritization, although will meet this definition. Although EPA discussed earlier, was the process EPA
EPA expects that such chemical will prioritize a ‘‘chemical substance’’ had been using to prioritize chemical
substances are not likely to be High- as a whole, EPA may base its substances for assessment under TSCA.
Priority candidates in light of the risk- identification of a potential candidate as EPA will evaluate one or more of these
related determination that the Agency a High-Priority Substance, and nine considerations, and chemical
must make pursuant to TSCA section ultimately the proposed designation, on substances that meet one or more of
5(a)(3). a single condition of use, provided the these criteria may be identified as
TSCA further requires EPA to go hazard and exposure associated with potential candidates for High-Priority
through a separate process of that single use support such a Substance designations. For example, if
determining which chemical substances designation. This proposal is based on a chemical substance is highly toxic and
on the TSCA Inventory are still actively the statutory definition of a High- used in consumer products, EPA may
being manufactured, and EPA has Priority Substance, which is clear that wish to consider that chemical
initiated a separate rulemaking for that the standard for the chemical as a whole substance as a potential High-Priority
purpose (RIN 2070–AK24). This can be met based on a single condition Substance candidate. EPA may also
distinction will inform EPA’s exposure of use (‘‘. . . because of a potential choose to identify potential candidates
judgments during the prioritization hazard and a potential route of exposure based on other criteria that suggest the
process. However, there is nothing in . . .’’). chemical substance may otherwise
TSCA that prohibits EPA from initiating Conversely, in identifying potential present a human health or
the prioritization process on an candidates for Low-Priority Substance environmental concern, as
‘‘inactive’’ chemical substance and designation, EPA is proposing that it contemplated in the ‘‘catch-all’’
ultimately designating that chemical will seek to identify chemical provision (9). The fact that a chemical
substance as either a High-Priority substances where the information substance meets one of these criteria is
Substances (e.g., if exposures of concern indicates that hazard and exposure not determinative of an outcome,
arise from ongoing uses) or Low-Priority potential for ‘‘all conditions of use’’ are including whether or not EPA will
Substance. so low that EPA can confidently set that select the chemical substance to go into
chemical substance aside without doing the prioritization process and/or the
F. Pre-Prioritization Considerations priority designation that the chemical
further evaluation. By comparison, then,
As discussed earlier, TSCA requires TSCA’s definition of Low-Priority substance will ultimately receive.
sradovich on DSK3GMQ082PROD with PROPOSALS
that EPA establish a process, including Substance (‘‘. . . based on sufficient Conversely, chemical substances that
criteria for designating a chemical information, such substance does not meet none of these criteria may be good
substance as either a High-Priority meet the standard for [. . .] a high- potential candidates for Low-Priority
Substances or Low-Priority Substance. priority substance . . .’’) is fairly Substance designation. The
15 U.S.C. 2605(b)(1). Aside from the rigorous, and effectively requires EPA to considerations are intended to serve as
statutory preferences for chemical determine that under no condition of a general guide for the Agency, based on
substances on the 2014 Update to the use does the chemical meet the High- EPA’s current understanding of
TSCA Work Plan (Ref. 1), the statute Priority Substance standard. important considerations regarding
VerDate Sep<11>2014 17:33 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00033 Fmt 4702 Sfmt 4702 E:\FR\FM\17JAP1.SGM 17JAP1](https://thefederalregister.org/doc/82_FR_4835/page/6.svg)
![4834 Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
found at http://www2.epa.gov/laws- responsibilities between the Federal Dated: December 27, 2016
regulations/laws-and-executive-orders. Government and Indian tribes. Thus, Gina McCarthy,
A. Executive Order 12866: Regulatory Executive Order 13175 does not apply Administrator.
Planning and Review and Executive to this action. Therefore, 40 CFR chapter I,
Order 13563: Improving Regulation and subchapter R, is proposed to be
G. Executive Order 13045: Protection of amended as follows:
Regulatory Review Children From Environmental Health
This action is a significant regulatory Risks and Safety Risks PART 702—[AMENDED]
action that was submitted to the Office
of Management and Budget (OMB) for EPA interprets Executive Order 13045 ■ 1. The authority citation for part 702
review under Executive Orders 12866 (62 FR 19885, April 23, 1997) as is revised to read as follows:
(58 FR 51735, October 4, 1993) and applying only to those regulatory Authority: 15 U.S.C. 2605 and 2619.
13563 (76 FR 3821, January 21, 2011). actions that concern environmental
health or safety risks that the EPA has ■ 2. Add subpart A to read as follows:
Any changes made in response to OMB
recommendations have been reason to believe may PART 702—GENERAL PRACTICES
documented in the docket. disproportionately affect children, per AND PROCEDURES
the definition of ‘‘covered regulatory
B. Paperwork Reduction Act (PRA) Subpart A—Procedures for Prioritization of
action’’ in section 2–202 of the
This action does not contain any Executive Order. This action is not Chemical Substances for Risk Evaluation
information collection activities that subject to Executive Order 13045 702.1 General Provisions.
require approval under the PRA, 44 because it does not concern an 702.3 Definitions.
U.S.C. 3501 et seq. This rulemaking 702.5 Considerations for Potential
environmental health risk or safety risk.
addresses internal EPA operations and Candidates for Prioritization.
procedures and does not impose any H. Executive Order 13211: Actions 702.7 Candidate Selection and Screening
Concerning Regulations That Review.
requirements on the public. 702.9 Initiation of Prioritization Process.
Significantly Affect Energy Supply, 702.11 Proposed Priority Designation.
C. Regulatory Flexibility Act (RFA)
Distribution, or Use 702.13 FinaL Priority Designation.
I certify under section 605(b) of the 702.15 Revision of Designation.
RFA, 5 U.S.C. 601 et seq., that this This action is not a ‘‘significant 702.17 Effect of Designation as a Low-
action will not have a significant energy action’’ as defined in Executive Priority Substance.
economic impact on a substantial Order 13211 (66 FR 28355, May 22, 702.19 Effect of Designation as a High-
number of small entities. This 2001), because it is not likely to have a Priority Substance.
rulemaking addresses internal EPA significant adverse effect on the supply, * * * * *
operations and procedures and does not distribution or use of energy. This Authority: 15 U.S.C. 2605 and 2619.
impose any requirements on the public, rulemaking addresses internal EPA
including small entities. operations and procedures and does not Subpart A—Procedures for
D. Unfunded Mandates Reform Act impose any requirements on the public. Prioritization of Chemical Substances
(UMRA) for Risk Evaluation
I. National Technology Transfer and
This action does not contain any Advancement Act (NTTAA) § 702.1 General Provisions.
unfunded mandate as described in (a) Purpose. This regulation
UMRA, 2 U.S.C. 1531–1538, and does This rulemaking does not involve any establishes the risk-based screening
not significantly or uniquely affect small technical standards, and is therefore not process for designating chemical
governments. The action imposes no subject to considerations under NTTAA substances as a High-Priority Substance
enforceable duty on any state, local or section 12(d), 15 U.S.C. 272 note. or a Low-Priority Substance for risk
tribal governments or the private sector. J. Executive Order 12898: Federal evaluation as required under section
Actions To Address Environmental 6(b) of the Toxic Substances Control
E. Executive Order 13132: Federalism
Justice in Minority Populations and Act, as amended (15 U.S.C. 2605(b)).
This action does not have federalism (b) Scope of designations. EPA will
implications as specified in Executive Low-Income Populations
make priority designations pursuant to
Order 13132 (64 FR 43255, August 10, This action does not establish an these procedures for a chemical
1999). It will not have substantial direct environmental health or safety standard, substance, not for a specific condition or
effects on the states, on the relationship and is therefore not is not subject to conditions of use of a chemical
between the national government and environmental justice considerations substance.
the states, or on the distribution of under Executive Order 12898 (59 FR (c) Categories of chemical substances.
power and responsibilities among the Nothing in this subpart shall be
7629, February 16, 1994). This
various levels of government. interpreted as a limitation on EPA’s
rulemaking addresses internal EPA
authority under 15 U.S.C. 2625(c) to
F. Executive Order 13175: Consultation operations and procedures and does not
take action, including the actions
and Coordination With Indian Tribal have any impact on human health or the contemplated in this subpart, on a
Governments environment. category of chemical substances.
sradovich on DSK3GMQ082PROD with PROPOSALS
This action does not have tribal List of Subjects in 40 CFR Part 702 (d) Prioritization timeframe. The
implications as specified in Executive Agency will publish a final priority
Order 13175 (65 FR 67249, November 9, Environmental protection, Chemicals, designation for a chemical substance in
2000). It will not have substantial direct Chemical substances, Hazardous no fewer than 9 months and no longer
effects on one or more Indian tribes, on substances, Health and safety, than 1 year following initiation of
the relationship between the Federal Prioritization, Screening, Toxic prioritization pursuant to 40 CFR 702.9.
Government and Indian tribes, or on the substances. (e) Metals or metal compounds. In
distribution of power and identifying priorities for chemical
VerDate Sep<11>2014 17:33 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00037 Fmt 4702 Sfmt 4702 E:\FR\FM\17JAP1.SGM 17JAP1](https://thefederalregister.org/doc/82_FR_4835/page/10.svg)
![Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules 4837
§ 702.15 Revision of Designation. action and is not subject to judicial FOR FURTHER INFORMATION CONTACT:
EPA may revise a final designation of review. Kristi Thornton, Consumer Policy
* * * * * Division, Consumer and Governmental
chemical substance from Low-Priority to
[FR Doc. 2017–00051 Filed 1–13–17; 8:45 am] Affairs Bureau, at (202) 418–2467 or
High-Priority Substance at any time
BILLING CODE 6560–50–P email: Kristi.Thornton@fcc.gov.
based on information available to the
Agency. To revise such a designation, This is a
SUPPLEMENTARY INFORMATION:
EPA will re-screen the chemical summary of the Commission’s
substance pursuant to 40 CFR 702.7(c), FEDERAL COMMUNICATIONS document, Report No. 3066, released
COMMISSION January 6, 2017. The full text of the
re-initiate the prioritization process on
that chemical substance in accordance Petition is available for viewing and
47 CFR Part 64 copying at the FCC Reference
with 40 CFR 702.9, propose a priority
designation pursuant to 40 CFR 702.11, [CG Docket No. 02–278; Report No. 3066] Information Center, 445 12th Street SW.,
and finalize the priority designation Room CY–A257, Washington, DC 20554.
Petition for Reconsideration of Action It also may be accessed online via the
pursuant to 40 CFR 702.13. EPA will not in Rulemaking Proceeding Commission’s Electronic Comment
revise a final designation of a chemical
AGENCY: Federal Communications Filing System at: https://www.fcc.gov/
substance from a High-Priority ecfs/filing/1217190700960/document/
Substance designation to Low-Priority. Commission.
ACTION: Petition for reconsideration.
1217190700960fd71. The Commission
§ 702.17 Effect of Designation as a Low- will not send a copy of this document
Priority Substance. SUMMARY: A Petition for Reconsideration pursuant to the Congressional Review
(Petition) has been filed in the Act, 5 U.S.C. 801(a)(1)(A), because this
Designation of a chemical substance Commission’s rulemaking proceeding, document does not have an impact on
as a Low-Priority Substance under 40 Sarah E. Ducich and Mark W. Brennan any rules of particular applicability.
CFR 702.3 means that a risk evaluation on behalf of Navient Corp., Joseph Subject: In the Matter of Rules and
of the chemical substance is not Popevis and Rich Benenson on behalf of Regulations Implementing the
warranted at the time, but does not Nelnet Servicing LLC, Rebecca Emily Telephone Consumer Protection Act of
preclude EPA from later revising the Rapp on behalf of Great Lakes Higher 1991, FCC 16–99, published at 81 FR
designation pursuant to 40 CFR 702.15, Education Corporation, Jason L. 80594, November 16, 2016, in CG
if warranted. Swartley on behalf of Pennsylvania Docket No. 02–278. This document is
Higher Education Assistance Agency, being published pursuant to 47 CFR
§ 702.19 Effect of Designation as a High- and Winfield P. Crigler on behalf of
Priority Substance.
1.429(e). See also 47 CFR 1.4(b)(1) and
Student Loan Servicing Alliance. 1.429(f), (g).
Final designation of a chemical DATES: Oppositions to the Petition must
Number of Petitions Filed: 1.
substance as a High-Priority Substance be filed on or before February 1, 2017.
Replies to an opposition must be filed Federal Communications Commission.
under 40 CFR 702.13 initiates a risk
on or before February 13, 2017. Marlene H. Dortch,
evaluation pursuant to 40 CFR 702,
subpart B. Designation as a High- ADDRESSES: Federal Communications Secretary.
Priority Substance is not a final agency Commission, 445 12th Street SW., [FR Doc. 2017–00848 Filed 1–13–17; 8:45 am]
Washington, DC 20554. BILLING CODE 6712–01–P
sradovich on DSK3GMQ082PROD with PROPOSALS
VerDate Sep<11>2014 17:33 Jan 13, 2017 Jkt 241001 PO 00000 Frm 00040 Fmt 4702 Sfmt 9990 E:\FR\FM\17JAP1.SGM 17JAP1](https://thefederalregister.org/doc/82_FR_4835/page/13.svg)
Document Created: 2017-01-14 01:44:54
Document Modified: 2017-01-14 01:44:54
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Proposed Rules | |
| Action | Proposed rule. | |
| Dates | Comments must be received on or before March 20, 2017. | |
| Contact | For technical information contact: Ryan Schmit, Immediate Office, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460- | |
| FR Citation | 82 FR 4825 | |
| RIN Number | 2070-AK23 | |
| CFR Associated | Environmental Protection; Chemicals; Chemical Substances; Hazardous Substances; Health and Safety; Prioritization; Screening and Toxic Substances |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR