/>iThe U.S. Environmental Protection Agency (EPA) proposed on July 28, 2016, revisions to the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) with revisions to the Occupational Safety and Health Administration's (OSHA) Hazard Communications Standard (HCS) occasioned by OSHA's March 2012 final rule modifying the HCS to conform to the United Nations' (U.N.) Globally Harmonized System of Classification and Labelling of Chemicals (GHS), changes to OSHA's Respiratory Protection Standard, and the National Institute for Occupational Safety and Health (NIOSH) respirator certification requirements pertaining to respiratory protection of workers from exposure to chemicals. EPA states that it is also proposing changes to regulations based on issues that it identified, as well as issues raised by public commenters, for significant new use rules (SNUR) previously proposed and issued under these regulations. Additionally, EPA claims to propose a "minor" change to reporting requirements for premanufacture notices (PMN) and other TSCA Section 5 notices. EPA states that it expects the changes "to have minimal impacts on the costs and burdens of complying, while updating the significant new use reporting requirements to assist in addressing any potential effects to human health and the environment." Comments are dueSeptember 26, 2016.
Commentary
Although the notice downplays them (which is reflected in the anodyne trade press articles on the proposal), the proposal raises significant and complex issues. There may well be good reasons for several of the proposed changes. The minimal discussion provided in the notice and the lack of adequate public debate having occurred prior to its issuance raise troubling questions about the legal basis for, scope of, and complexity of the proposed changes, some of which may apply retroactively. The confusion the proposal can be expected to cause could have been avoided had adequate discussion preceded its publication, or at the least EPA could have raised these issues in the proposed rule's preamble to focus stakeholders' attention appropriately.
We see several issues. First, stakeholders in the pesticide area know well the challenges and legal and regulatory ambiguities that have arisen regarding EPA's efforts to align pesticide labeling under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) with GHS requirements. EPA has devoted considerable effort to clarifying the application of HCS/GHS requirements to FIFRA labeling, and unresolved issues still remain. See Pesticide Registration (PR) Notice 2012-1, Material Safety Data Sheets as Pesticide Labeling; 77 Fed. Reg. 23713 (Apr. 20, 2012).
Given the number and complexity of issues covered in the proposed rule, it is evident that EPA has been working on it for some time. Sixty days leaves little time to comment, particularly given the summer holiday season and the many important TSCA initiatives underway and on which stakeholder attention is focused as a result of EPA's implementation of TSCA reform. As EPA knows well, stakeholders are busy and preoccupied in working to understand the new requirements, preparing for the upcoming public meetings on August 9-10 and the industry meeting on August 11-12, and preparing for all of the other issues and requirements that have a short clock (not least of which are the effects of the changes in Section 5).
Second, we also question why, after an extensive legislative debate that produced an amended TSCA, EPA would propose to include the hierarchy of controls (HOC) approach in its significant new use provisions. We recognize and appreciate the importance of HOC as an element in a system to manage or eliminate occupational risks and note the inclusion of this approach proposed in earlier legislative TSCA reform. These included S. 3209, the Safe Chemicals Act of 2010 (which included HOC in changes to Section 9(c)) and H.R. 5820, the Toxic Chemicals Safety Act of 2010 (which proposed to include HOC in Section 6(c)(2)(F)). As it debated TSCA reform over the succeeding six years, Congress decided in its wisdom not to include the concept of HOC in TSCA as amended. The re-emergence of HOC embedded in a proposed rule issued with no fanfare, and which studiously avoids reference to any of these important implications, raises many questions, not the least of which is if Congress declined to pursue this approach in amending TSCA, is it at least worth discussing the wisdom of its inclusion in this proposed rule? The subtly of EPA's messaging here is troubling.
Third, we question whether EPA considered the impact of amended TSCA on the proposal. Based on a quick read, we note the citations to TSCA appear to be to old TSCA. Apart from correcting the citations, however, new TSCA may materially impact the content of the proposal and it is unclear if EPA's review considered this possibility.
Finally, we will discuss in a separate memorandum some interesting anomalies that appear in the proposal's discussion of bona fide requests and the disclosure of information potentially considered confidential. We will explore this issue in a separate memorandum next week.
Proposed Changes to 40 C.F.R. Section 721.63, Protection in the Workplace
According to the notice, EPA is proposing changes to 40 C.F.R. Section 721.63 based on changes that have occurred in respiratory protection requirements since 1989. In June 1995, NIOSH updated and modernized its federal regulation for testing and certifying non-powered air-purifying particulate respirators (42 C.F.R. Part 84). The 42 C.F.R. Part 84 respirators have passed a more demanding certification test than older respirators previously certified under 30 C.F.R. Part 11, and provide increased worker protection. In January 1998, OSHA replaced the respiratory protection standards it adopted in 1971 with the revised Respiratory Protection Standard (29 C.F.R. Section 1910.134). In August 2006, OSHA modified the Respiratory Protection Standard by adding definitions, as well as maximum use concentration, and assigned protection factor requirements.
According to EPA, due to these changes, the respirators currently listed in 40 C.F.R. Section 721.63 may no longer meet the current NIOSH/OSHA criteria for respirator selection and use. EPA proposes to update the language pertaining to respiratory protection requirements to be consistent with both OSHA and NIOSH requirements. Under the proposed rule, 40 C.F.R. Section 721.63(a)(4), which requires that respirators be used in accordance with 30 C.F.R. Part 11, would instead cite 42 C.F.R. Part 84, the most updated NIOSH regulation for testing and certifying respirators. EPA states that the change would apply to all previously issued SNURs that contain significant new use requirements pertaining to respiratory protection to make clear that manufacturers and processors subject to current SNURs can follow updated respiratory protection requirements without triggering a significant new use notification (SNUN) requirement. EPA will cite the updated language when issuing new SNURs as appropriate. EPA is proposing updated NIOSH-certified respirator language in 40 C.F.R. Section 721.63(a)(5) to standardize the use of the new respirator language by allowing EPA to cross-reference the respirator language for new chemical SNURs rather than impose the respirator language on a case-by-case basis. The proposed rule would allow persons subject to SNURs with older respirator requirements to avoid triggering a SNUN requirement by continuing to use those respirators, if they are available.
EPA proposes to revise 40 C.F.R. Section 721.63 to make it a significant new use not to implement a HOC to protect workers. Persons subject to applicable SNURs would be required to determine and use appropriate engineering and administrative controls before using personal protective equipment (PPE) for worker protection, similar to the requirements in OSHA standards at 29 C.F.R. Section 1910.134(a)(1) and guidance in Appendix B to Subpart I of 29 C.F.R. Part 1910. EPA notes that it received comments to proposed SNURs that it issued on December 28, 2011. According to EPA, the comments generally stated that EPA's approach of exclusively identifying the absence of adequate PPE as a significant new use instead of engineering and administrative controls did not follow the best occupational health and safety practices. In the June 26, 2013, final SNURs, EPA agreed that a HOC should be applied and that PPE should be the last option to control exposures. EPA states that all new chemical SNURs published since June 26, 2013, have included language to consider and implement engineering controls and administrative controls where feasible when the SNURs contained significant new uses pertaining to the lack of PPE for workers. EPA proposes to revise 40 C.F.R. Section 721.63(a)(1) and (a)(4) to add language that requires consideration and use of engineering and administrative controls where feasible before PPE for worker protection. The proposed change would affect SNURs issued after this proposed rule becomes a final effective rule, and would affect previously issued SNURs that incorporate worker protection referencing the existing 40 C.F.R. Section 721.63(a)(1) and (a)(4) regulations.
Proposed Changes to 40 C.F.R. Section 721.72, Hazard Communication Program
EPA proposes changes to 40 C.F.R. Section 721.72 based on the changes to 29 C.F.R. Section 1910.1200, OSHA's modified HCS. In March 2012, OSHA modified the HCS to conform to the UN's GHS to enhance the effectiveness of the HCS by ensuring that employees are apprised of the chemical hazards to which they may be exposed, and by reducing the incidence of chemical-related occupational illnesses and injuries. The HCS modifications include revised criteria for classification of chemical hazards; revised labeling provisions that include requirements for use of standardized signal words, pictograms, hazard statements, and precautionary statements; a specified format for safety data sheets (SDS); and related revisions to definitions of terms used in the HCS and requirements for employee training on labels and SDSs.
EPA proposes to add new paragraphs (i) and (j) that EPA would use when issuing hazard communication requirements for SNURs issued after this proposed rule has been issued in final. The new paragraph (i) would require that a written hazard communication program be developed and implemented for the substance in each workplace in accordance with the OSHA HCS. According to EPA, this proposed approach would maintain consistency in compliance for persons subject to TSCA and OSHA regulations for the same activity. The new paragraph (j) describes specific statements and other warnings that could be required for SNURs for substances identified in Subpart E. EPA states that the specific statements and warnings that could be required would be based on EPA's risk assessment of the chemical substance and would be consistent with the OSHA HCS and GHS recommendations.
EPA proposes to update 40 C.F.R. Section 721.72 paragraphs (a) through (h) to be consistent with both OSHA requirements and GHS recommendations. When the rule is issued in final, these changes would apply to individual SNURs in Subpart E issued before the effective date of the final rule. EPA proposes changes to 40 C.F.R. Section 721.72 paragraphs (a), (c), and (d) to change using the word material safety data sheet (MSDS) to SDS and to allow easily accessible electronic versions and other alternatives to maintaining paper copies of the SDS. According to EPA, these changes would apply to any previously issued SNUR in Subpart E that cites these paragraphs. EPA also proposes changes pertaining to hazard and precautionary statements that are listed in 40 C.F.R. Section 721.72 paragraphs (g) and (h) to be consistent with statements required under the OSHA HCS and recommended by the GHS. The proposed changes would add new precautionary and hazard statements. According to the proposed rule, while the previously issued SNUR precautionary and hazard statements would be retained solely for previously issued SNURs, EPA proposes to identify which of the proposed new statements can be used as alternatives. EPA proposes that manufacturers and processors subject to a previously issued SNUR have the option to use the prior older precautionary and hazard statements or use the new alternative statements that are consistent with the OSHA HCS or GHS recommendations to comply with the SNUR. EPA proposes language allowing any person subject to a previously issued SNUR for a substance identified in Subpart E containing requirements for 40 C.F.R. Section 721.72 paragraphs (a) through (h) to comply with those requirements by following the requirements of the proposed 40 C.F.R. Section 721.72 paragraph (i), which is being proposed for use in future SNURs, and using any statements specified for that substance in the proposed 40 C.F.R. Section 721.72 paragraphs (g) or (h).
Clarification of the Use of 40 C.F.R. Section 721.80, Industrial Commercial and Consumer Activities
EPA states that it is clarifying its use of the significant new use for new chemical SNURs described at 40 C.F.R. Section 721.80(j), which identifies as a significant new use, "Use other than as described in the premanufacture notice referenced in subpart E of this part for the substance." When EPA issues a SNUR using the designation at Section 721.80(j) and that use described in the PMN is claimed as confidential, EPA cites Section 721.80(j). In identifying the significant new use in Subpart E for certain previously issued SNURs where the use described in the PMN was not claimed confidential, EPA cited 40 C.F.R. Section 721.80(j) and included the PMN use described in the PMN in parentheses. EPA states that it has received public comments in response to proposed SNURs and pre-notice inquiries for SNUNs that manufacturers and processors subject to SNURs "find it confusing when EPA cites 40 CFR 721.80(j) and then identifies the PMN use in parentheses." According to these comments and inquiries, when EPA cites the new use this way, it appears as though the significant new use is the use in the parentheses, where the significant new use is actually use other than the use in parentheses. To identify the significant new use more clearly, EPA states that it has changed this procedure to cite 40 C.F.R. Section 721.80(j) only when the use described in the PMN is confidential. When the use described in the PMN is not confidential, EPA intends to identify the significant new use by describing the use, such as in the following example: "A significant new use is any use other than as a pesticide intermediate."
Proposed Changes to 40 C.F.R. Section 721.91, Computation of Estimated Surface Water Concentrations: Instructions
When EPA issues a new chemical SNUR citing the significant new uses described in 40 C.F.R. Section 721.90 (a)(4), (b)(4), and (c)(4), the SNUR requires a SNUN if the results of the equation for computation of estimated surface water concentrations in 40 C.F.R. Section 721.91 exceed the level specified for that SNUR in Subpart E. The equation estimates surface water concentrations based on the amount of a chemical substance released from industrial processes and the flows of the water body. According to the proposed rule, the current equation does not consider amounts of a chemical substance released to a surface water after control technology such as wastewater treatment. EPA proposes to revise this requirement to allow manufacturers and processors to account for reductions in surface water concentrations resulting from wastewater treatment.
EPA states that because of "numerous questions" from manufacturers and processors about the phrase "predictable or purposeful release" in 40 C.F.R. Section 721.90, it proposes to clarify the meaning of that phrase. EPA uses the phrase to qualify significant new uses pertaining to releases to water in 40 C.F.R. Section 721.90. According to the proposed rule, as described in the April 29, 1987, proposed rule, Proposed General Provisions for New Chemicals Follow-up, the phrase predictable or purposeful does not include releases where true emergency conditions exist and SNUN is not possible. Therefore, EPA states, routine or repeated activity that results in releases to water or non-routine releases to water that are not due to emergency conditions would be included in the term predictable or purposeful. EPA did not intend the phrase "predictable or purposeful release" to limit its strict liability authority under the statute.
Proposed Changes to 40 C.F.R. Section 721.11, Determining Whether a Chemical Substance or a Specific Use Is Subject to This Part When the Chemical Substance Identity or Significant New Use Is Confidential
EPA notes that some new chemical SNURs have a significant new use designation that is a production volume limit or use other than described in the PMN that is based on confidential business information (CBI) contained in the PMN and that is therefore not disclosed in the published SNUR. Currently, for each SNUR that contains a significant new use designation that is CBI, that SNUR cross-references the bona fide procedure in the specific SNUR in Subpart E for 40 C.F.R. Section 721.1725. When the chemical identity in a SNUR is CBI, 40 C.F.R. Section 721.11 provides a means by which bona fide submitters can determine whether their substance is subject to the SNUR. EPA notes that chemical identity is not the only information contained in a SNUR that may be claimed as CBI, however. EPA proposes to modify the bona fide procedure in 40 C.F.R. Section 721.11 so that it applies to all SNURs that contain any confidential information in the SNUR, including the significant new use. EPA states that it "believes it would be more efficient to have a bona fide procedure for determining confidential significant new uses in subpart A rather than referencing 40 CFR 721.1725(b)(1) each time EPA issues a SNUR containing a confidential significant new use designation." In addition, EPA proposes to modify the bona fide procedure that allows EPA to disclose the confidential significant new use designations to a manufacturer or processor who has established a bona fide intent to manufacture (including import) or process a particular chemical substance.
Proposed Changes for Submission of SDS(s) with PMNs, SNUNs, Low Volume Exemptions (LVE), Low Release and Exposure Exemptions (LoREX), and Test Marketing Exemption (TME) Applications
EPA proposes to revise requirements in 40 C.F.R. Sections 720.38, 720.45, and 723.50 to require that any SDS already developed to comply either with OSHA requirements or already developed by a notice submitter for other purposes must also be submitted as part of the notification (PMN, SNUN, LVE, LoREX, or TME application) under TSCA Section 5. According to EPA, many submitters already submit available SDSs as part of their submission and the information contained in SDSs is "often useful" for EPA's assessments of chemicals. EPA states that the proposed revision would not require submitters to develop an SDS. It would only require a submitter to submit an SDS that has already been developed to the extent it is known or reasonably ascertainable by the submitter.
Fixing Typographical Errors and Other Non-Substantive Changes
EPA proposes to correct several typographical errors and more accurately use the terms manufacture, manufacturer, and manufacturing in the regulatory text of 40 C.F.R. Parts 720, 721, and 723.
