On March 27, 2019, the U.S. Environmental Protection Agency (EPA) posted a signed final rule that will establish final significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 13 chemical substances that are the subject of premanufacture notices (PMN). The final rule is significant because the 13 chemical substances are not also subject to consent orders. During the review, EPA identified certain reasonably foreseen conditions of use that it designated as significant new uses in the final SNURs. The final SNURs effectively prohibit the designated new use unless a person submits a notice to EPA, EPA makes a determination, and it takes any necessary action to mitigate any identified potential risk. The final rule will be effective 60 days after publication in the Federal Register.

Under TSCA Section 5(a)(2), EPA’s determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance;
   
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance;
   
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance; and
   
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
   

EPA notes that in addition to these factors, TSCA authorizes EPA to consider any other relevant factors, including information it has on analogous substances. EPA states that to determine what would constitute a significant new use for the chemical substances that are the subject of these SNURs, it also considered relevant information about the toxicity of the chemical substances, likely human exposures, and environmental releases associated with possible uses.

Public Comments on the Proposed Rule and EPA Responses

As reported in our October 17, 2018, memorandum, “EPA Proposes SNURs that Break New Ground under Amended TSCA,” EPA issued on October 16, 2018, a proposed rulethat would establish SNURs for 13 chemical substances that are the subject of PMNs. 83 Fed. Reg. 52179. EPA states that it received public comments from 15 entities on the proposed rule. EPA’s responses are described below.

Challenges to Underlying TSCA Section 5(a)(3) Determinations

EPA states that it received multiple comments regarding the manner in which these proposed SNURs operate. One comment requested that, in light of alleged legal and factual deficiencies, EPA withdraw both the proposed SNURs and the underlying “not likely” determinations and instead issue determinations, TSCA Section 5(e) orders, and post-order Section 5(f)(4) SNURs based on a finding that the chemical substances “may present an unreasonable risk to health or the environment” under Section 5(a)(3)(B). Another comment stated that EPA may not rely on “non-5(e) SNURs” to make a “not likely” finding under Section 5(a)(3)(C) and has failed to provide a legal and factual basis for its determination as required by Section 5(g), “but nevertheless supports the need to promulgate these SNURs at this time because otherwise there will be no protections at all in place for these chemical substances.” According to the commenter, EPA found risks to workers for several of the chemical substances subject to these proposed SNURs, absent protective measures that EPA expects will be implemented and will provide sufficient protection, and that EPA’s risk determination for these chemicals should not assume there will be full compliance with all of the controls recommended in an associated safety data sheet (SDS) and that such compliance would be adequate to protect workers.

EPA responded that these comments constitute challenges to certain TSCA Section 5(a)(3) determinations rather than to the basis for or the content of the SNURs, which EPA has promulgated using its discretion to issue SNURs under TSCA Section 5(a)(2). Because these comments are not germane to the rulemaking, EPA is not responding to these comments in the notice and declines to withdraw the SNURs on the basis of these comments. Regardless, EPA notes that it has already defended the legal and factual basis for the TSCA Section 5(a)(3) determinations that these comments reference in a prior legal challenge. See Brief of EPA in NRDC v. EPA, 2d Cir. Docket No. 18-25.

Regulation of Workplace Risks

Several commenters argued that where EPA finds unreasonable risks to workers in the absence of certain protective measures (e.g., personal protective equipment (PPE), engineering controls), EPA must identify as a significant new use any use of the chemical that occurs without those protections. Specifically, according to the commenters, EPA must issue an order to address workplace risks -- as well as consider promulgating a SNUR -- because in these circumstances “the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination of such activities, may present an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including an unreasonable risk to a potentially exposed subpopulation.” The commenters state that EPA “shall issue an order . . . to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of such substance or to prohibit or limit any combination of such activities to the extent necessary to protect against an unreasonable risk of injury to health or the environment.” After issuing such an order, EPA must consider whether to promulgate a SNUR “that identifies as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance that does not conform to the restrictions imposed by the . . . order” or publish a statement justifying its decision not to promulgate a SNUR. According to the commenters, Congress required EPA to regulate unreasonable risks that a chemical substance “may present” under TSCA. The commenters contend that allowing EPA to assume that sufficient protective measures will be implemented to eliminate potential unreasonable risks would essentially negate TSCA Section 5(e), which could not be Congress’s intention. And, the commenters claim, EPA cannot find that a chemical is not likely to present an unreasonable risk based solely on its unjustified “expectation” that sufficient protective measures will be implemented. EPA effectively found risks to workers for several chemical substances subject to the proposed SNURs, absent protective measures that EPA “expects” will be implemented and will provide sufficient protection. Commenters assert that EPA’s risk determination for these chemicals should not assume there will be full compliance with all of the controls recommended in an associated SDS and that such compliance would be adequate to protect workers. Because EPA relied on these protective measures in its analysis of risk, commenters state that EPA should identify any condition of use without these protective measures to be a significant new use, meriting advance notification to EPA.

EPA responds that to the extent these comments argue that it should have issued orders under TSCA Section 5(e) or 5(f), EPA believes they are beyond the scope of the SNUR for which EPA is specifically soliciting comments and are properly directed to the Section 5(a)(3) determinations that pertain to the underlying PMNs for the SNUR. EPA is therefore not responding to these comments here. EPA notes that it is responding to comments that pertain specifically to the SNUR, i.e., those regarding the uses that should be subject to the SNUR, as well as the assertion that EPA must include certain worker protection provisions in the SNURs on the basis of TSCA Section 5(f)(4).

EPA disagrees with the comment that, with respect to scenarios where it expects that worker protection requirements under other federal/state authorities would mitigate risks to workers, it must designate all uses without those protections as “significant new uses.” According to EPA, it has discretion as to which new uses to designate as significant. As mentioned in the “not likely” determination documents for the subject PMNs in this batch of SNURs, in exercising its discretion regarding which new uses should be designated as significant under Section 5(a)(2), EPA expects compliance with federal and state laws, such as worker protection standards or disposal restrictions, unless case-specific facts indicate otherwise. Further, EPA states that any workplace risks will be mitigated if exposures are appropriately controlled, and EPA expects that employers will require and workers will use the appropriate controls (e.g., PPE such as impervious gloves and/or respirators), consistent with the SDS prepared by the PMN submitter, in a manner adequate to protect them.

With respect to comments regarding TSCA Section 5(f)(4), EPA notes that because no applicable TSCA Section 5(e) or 5(f) orders have been issued, the requirements of TSCA Section 5(f)(4) are not triggered. Therefore, EPA need not make changes in the proposed SNUR to correspond to Section 5(e) and 5(f) orders that have not been issued.

SNURs Lack Provisions to Notify Downstream Processors and Users of EPA Concerns

One commenter suggested that the proposed SNURs lack notification requirements for worker protection and hazard communication programs to ensure that risks to workers and the public from downstream activities are identified and addressed and fail to provide notice to downstream processors and users of the PMN substance’s environmental effects and EPA’s required limits on release to water. EPA responded that 40 C.F.R. Section 721.5 requires manufacturers and processors to either file a significant new use notice (SNUN) before distributing the chemical substance in commerce or notify downstream customers of the existence of a SNUR on a particular chemical substance (or determine that such users have notice). Thus, according to EPA, one of two possibilities will occur: (1) downstream customers do receive notice of the SNUR; or (2) notification of downstream uses becomes unnecessary because the manufacturer or processors submit a SNUN to EPA, and EPA either determines that such manufacture and processing is not likely to present unreasonable risk, or takes appropriate regulatory action to address the risks.

Impact on Downstream Users

According to EPA, one commenter similarly identified impacts of SNURs on downstream users who “often must struggle to figure out when a product they use is covered by a SNUR,” particularly when the proposed SNUR provides only the generic name of a confidential chemical substance, or when the proposed SNUR covers the use of a chemical substance in an article. The commenter also noted that the burden and compliance risks are greatest when the proposed SNUR contains reporting requirements. The commenter indicated that downstream users may depend on voluntary disclosure by the supplier or a downstream formulator/distributor, in contrast to the mandatory reporting requirements in place under a Section 5(e) order. The comment concludes that EPA should take steps to close the gap between proposed and final SNURs by issuing the final expeditiously, by notifying submitters of EPA’s likelihood of promulgating a SNUR, and by requesting companies alert downstream users of impending SNURs. EPA states that it is aware of the impacts of the issuance of a SNUR, including and beyond those specific to the actual TSCA notification requirement. EPA’s focus is to take appropriate action under TSCA to control potential risks to human health or the environment from exposure or release of a new chemical, including requiring notification of potential significant new uses.

Confidential Business Information (CBI) and Disclosure of Health and Safety Information

EPA states that it received multiple comments critical of its process in promulgating the proposed SNURs. One commenter requested that EPA extend the comment period and make CBI available for review with appropriate safeguards to avoid depriving the public of a meaningful opportunity to participate. The commenter stated that TSCA does not extend CBI protection to any health and safety study submitted under TSCA, including underlying information and occupational exposure studies. In addition to the scientific analyses developed by EPA (e.g., engineering reports, Structure Activity Team (SAT) reports), which fall under this definition, other information that is generally required to be submitted with PMNs, such as toxicity studies, information on worker exposure, and the majority of information in SDSs, also falls under this definition. EPA must disclose this information to the public. Despite these mandates, the commenter argues that EPA has failed to disclose this health and safety information. The comment states that EPA’s SAT reports, engineering reports, and exposure reports all constitute or contain health and safety information that EPA must disclose, yet for P-16-575, for example, EPA has largely redacted these documents.

EPA states that it recognizes that TSCA Section 14 does not protect from disclosure certain confidential information, including health and safety information. Section 14 does not require that EPA make a final confidentiality determination for all information submitted under TSCA and claimed as CBI as part of a PMN review, however, and EPA has not made a determination regarding the eligibility for confidential treatment of the information referenced in the comment. Here, EPA states that it balanced the need for sufficient information in the public record to explain fully the bases for its decisions with the protections for CBI in Section 14. With regard to EPA technical support reports underlying the Section 5 determination, they are not covered by Section 14(b)(2), which specifically refers to health and safety studies submitted to EPA. According to EPA, it provided sufficient information in the public record to explain fully the bases for its decisions while preserving the submitter’s confidentiality claims through generally accepted means, including the aggregation of certain data in the public docket, presentation of ranges of values, or masking of manufacturing site locations to prevent CBI disclosure.

Identifying “Significant New Uses” for SNURs

The commenter considers the approach taken for these proposed SNURs that found “not likely to present an unreasonable risk” under the conditions of use described in the PMNs to be generally consistent with the requirements of the 2016 amendments to TSCA. To the extent that this approach also represents potential improvements in EPA’s ability to provide more timely review of PMNs, the commenter supports the approach. The commenter encourages EPA to take a risk-based approach -- with particular focus on changes occurring in the conditions of use of a substance that can affect exposure (i.e., human exposure and environmental releases) -- in identifying what changes in the conditions of use that will constitute significant new uses, and to consider the potential burden on downstream users when designating potential new uses to be significant. The commenter further encouraged EPA to use its discretion to consider “all relevant factors,” including the cost of submitting SNUNs, the burden of compliance with SNUR reporting requirements such as Chemical Data Reporting (CDR) and TSCA Section 12(b) export notification reporting, and the compliance risk caused by vague regulations, in promulgating TSCA Section 5(a)(2) SNURs to minimize regulatory burdens on downstream users.

EPA agrees that it should -- and does --- identify significant new uses only after consideration of the “relevant factors” identified in TSCA Section 5(a)(2): (1) the “projected manufacturing or processing volume of a chemical substance”; (2) the “type or form of exposure of human beings or the environment” to the chemical substance; (3) the “magnitude and duration of exposure of human beings or the environment” to the environment; and (4) the “reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal” of the chemical substance. EPA typically does not have all of the data specific enough for each of the aforementioned factors to support risk assessment(s) for anticipated changes that are not part of the PMN, however. Hence, such information would be provided if and when a SNUN is submitted that would provide such information for the significant new use. EPA notes that another commenter supported this approach, explaining that future risks not contemplated in the PMN will be addressed by analysis of a SNUN that streamlines the current system, which typically runs much longer than the 90 days proscribed in TSCA. As to other regulatory requirements such as CDR or export notification, EPA understands the impact and coordinates with those programs to eliminate inefficiencies. Furthermore, EPA flags chemical substances on the TSCA Inventory that are regulated with a SNUR. For interpretation of SNUR notification requirements, EPA encourages the regulated community to contact EPA by using the options outlined in the “Addresses” and “For Further Information Contact” sections of the SNUR preamble.

Catch-All Significant New “Use”

One commenter suggested that EPA should generally designate as a significant new use any use of a chemical substance other than the uses EPA evaluated in its PMN review and determined are not likely to present an unreasonable risk. In particular, the commenter identified P-16-192, P-16-380-385, and 16-575 as SNURs for which other types of triggers for notification (e.g., manufacture in a certain physical form, or manufacture, processing, or use to result in inhalation exposure) were used. Although the commenter supports inclusion of these triggers, it comments that EPA must also require notification for use other than that which it has reviewed.

EPA responded that this suggested approach is overly broad. TSCA requires that EPA evaluate new chemicals under their conditions of use, including the intended, known, and reasonably foreseen circumstances of manufacture, processing, distribution in commerce, use, and disposal. Based upon EPA’s review of the relevant PMNs, EPA identified uses that are appropriate for designation as “significant new uses” to ensure that EPA has an opportunity to review those uses in a SNUN submission at a later date and address any unreasonable risks at that time. TSCA Section 5(a)(2) does not require EPA to take the catch-all approach advocated by commenters, and EPA states that it “believes a more tailored approach is warranted to avoid unduly burdensome regulations.”

Being More Specific in 40 C.F.R. Section 721.80

One commenter suggested that EPA must clearly specify the cross references to its general regulations in the SNURs. A number of proposed SNURs state that the significant new uses are “requirements as specified in 721.80.” Since 40 C.F.R. Section 721.80 contains 25 possible significant new use designations, this is misleading.

EPA states that it “understands the confusion.” Where one of the 25 specific significant new use designations in Section 721.80 is not being used, in the interest of transparency and clarity, EPA generally lists “Industrial, commercial, and consumer activities. Requirements as specified in § 721.80” and follows with a complete sentence describing the actual activity. According to the final rule, EPA will modify its approach so that where it is not citing a specific designation in Section 721.80, it will drop the phrase “Requirements as specified in § 721.80.” For example, the SNUR at 40 C.F.R. Section 721.11182 will be issued in final as:

(i) Industrial, commercial, and consumer activities. It is a significant new use to manufacture the substance other than in an amorphous form.

In response to this comment, EPA is making a similar change to these Section 721.80 designations in all the final SNURs in this batch rule, except the SNURs at Sections 721.11190 and 721.11191. Those two SNURs specifically cite Section 721.80(j), which is the confidential use identified in the associated PMN submission for those SNURs.

Regulatory Burden of SNURs for Safer Chemicals

One comment was regarding an enzyme used in the polymerization of glucose that would be subject to a proposed SNUR due to concerns with respiratory sensitization. The commenter stated that enzymes are recognized to have a positive and sustainable environmental profile and inherently low toxicity compared to other chemicals, and that this SNUR is a signal that it will be significantly more challenging to bring new enzymes to market and may decrease innovation that can address global challenges as highlighted by the United Nations (UN) Sustainable Development Goals. The commenter additionally voiced concern for the lengthy review time for PMN submissions.

To the extent the commenter is disputing the outcome of a PMN review, EPA states that these comments are more properly directed to the specific PMN determination and not this SNUR rulemaking. This comment constitutes challenges to the corresponding TSCA Section 5(a)(3) determinations rather than to the basis for or the content of the SNURs that EPA has promulgated using its discretion to issue SNURs under TSCA Section 5(a)(2). EPA states that nonetheless, it is aware of, and working to remedy, the increased length of time it has been taking to review and reach decision on Section 5 notices as it implements the amendments to TSCA.

Non-Animal Testing

One commenter supports this approach of addressing potential risks that the subject chemicals may present under reasonably foreseen conditions of use, while finding that under the intended conditions of use, they are not likely to present unreasonable risks. In contrast, the commenter states, in its early implementation of the amended TSCA, EPA addressed such potential risks in consent agreements with PMN submitters. In these cases, the commenter notes, EPA frequently required health and ecotoxicity testing. The commenter therefore supports EPA’s new approach, which is consistent with TSCA’s requirements to reduce and replace the use of vertebrate animals in the testing of chemical substances and promote the development and timely incorporation of new test methods and strategies that are not based on vertebrate animals. In addition, it protects human health and the environment by addressing potential risks when the conditions of use under which they arise are intended, either as identified in PMNs or in SNUNs, while reducing the burden on PMN submitters and streamlining the review process.

As mentioned in the preamble to the final rule, EPA states that any recommendation for information it identified was made based on its consideration of available screening-level data, if any, as well as other available information on appropriate testing for the chemical substance. Further, any such testing identified by EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models. EPA states that it also recognizes that whether testing/further information is needed will depend on the specific exposure and use scenario in the SNUN. EPA encourages all SNUN submitters to contact it to discuss any potential future testing. Furthermore, pursuant to TSCA Section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation on the use of alternative test methods and strategies (also called New Approach Methodologies (NAM)), if available, to generate the recommended test data. EPA states that it encourages dialog to help determine how best the submitter can meet both the data needs and the objective of TSCA Section 4(h).

Do Not Use SNURs as Information Gathering Tool, Tracking Tool

One commenter urged EPA to not rely on SNURs as tools for tracking use and production of chemicals or for otherwise gathering potentially useful information, but instead suggested that EPA rely on provisions like TSCA Section 8 that specifically authorize such acts. EPA states that it is not issuing a requirement to develop any data or information as a result of these SNURs. It is the responsibility of a SNUN submitter to provide any such information as required by TSCA Section 5 and the SNUN regulations at 40 C.F.R. Part 721. Regarding potentially useful information, EPA encourages all SNUN submitters to contact it to discuss any potential future testing.

Commentary

In issuing this batch of SNURs in final, EPA is taking a significant step in its implementation of new TSCA. In cases where EPA does not identify a need for specific testing, SNURs have several advantages over consent orders without compromising protection to health or the environment, as a violation of either would be a violation of TSCA Section 5(a). Most notably, SNURs are immediately protective across the supply chain, whereas consent orders apply only to the PMN submitter until the corresponding SNUR is promulgated.

Stakeholders have objected to EPA using SNURs without consent orders stating that such actions are not permitted by new TSCA. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg) is silent on non-order SNURs. Lautenberg requires that EPA issue a consent order to protect against risks that may arise from conditions of use that are “reasonably foreseen.” Issuing a SNUR to prohibit certain conditions of use absent submission and review of a SNUN is fully consistent with Lautenberg and fully protective of human health and the environment and strikes us as a creative way to optimize EPA’s SNUR authority while limiting the need for consent orders when intended conditions of use are not likely to present unreasonable risk. For example, with respect to the consolidated set of new chemicals identified as P-16-380 through P-16-385, EPA identified concerns for “lung effects and toxicity to aquatic organisms at concentrations that exceed 16 ppb if the chemical substances” are used without the restrictions specified in the SNUR. The SNUR prohibits uses that may result in inhalation exposure and prohibits releases from any manufacturing, processing, or use stream that would lead to a surface water concentration (SWC) exceeding 16 ppb. By issuing a SNUR to prohibit these specific, potentially problematic conditions of use, such conditions of use are no longer “reasonably foreseen.” With the SNUR in place, EPA can make a “not likely to present” finding under Section 5(a)(3)(C), thereby allowing the submitter to proceed with commercializing under the intended conditions of use for which EPA did not identify unreasonable risk. In our view, the non-order SNUR approach reflects a creative and efficient way for EPA to meet its obligations under Section 5(a). Under this approach, EPA reviews the intended, known, and reasonably foreseen conditions of use. If EPA only identifies potential risks for reasonably foreseen conditions of use and determines there is no need for testing to inform its assessment, EPA can use the non-order SNUR process to authorize commercialization under conditions that are not likely to present unreasonable risk, while explicitly prohibiting potential conditions of use that might present unreasonable risk. Our careful review of comments and EPA’s response to them leaves us unpersuaded by arguments that consent orders are more protective than SNURs. To the contrary, consent orders may be less protective because only the signatory of a consent order is bound by the restrictions of that order and a second manufacturer is authorized to commence any commercial activities once a substance that was commenced under a consent order appears on the TSCA Inventory. Arguments that a SNUR is not protective because a SNUR merely requires “notification” to EPA prior to commencing commercial activity fundamentally misconstrues the effect of a SNUR. A SNUN has the same statutory effect as a PMN. EPA’s review, determination, and needed actions must be completed for all Section 5(a) notices, including PMNs and SNUNs.

Non-order SNURs also help reduce the need for vertebrate testing. In using non-order SNURs, EPA is authorized to prohibit potentially problematic conditions of use absent additional information, whether additional information on hazard or exposure. In the example cited above in which EPA set a SWC limit of 16 ppb, if a person were contemplating a condition of use that might lead to an exceedance of 16 ppb, the person could discuss what aquatic toxicity tests may be undertaken to address EPA’s concerns for aquatic organisms. The testing might confirm the SWC limit, or the testing might justify a higher SWC limit (given EPA’s justifiably conservative assumptions, we find it unlikely that testing would lead to EPA seeking to lower the SWC limit). On the other hand, if the submitter and EPA agree that the substance is probably highly toxic to aquatic species even in the absence of test results on the substance itself, provided releases are well-controlled, there would be no need to undertake testing.

One commenter suggested that EPA issue SNURs to limit conditions of use to those specified in a PMN, effectively making all other conditions of use foreseeable. We concur with EPA’s view that such an approach is overly broad and well beyond what Lautenberg requires. Such an approach is, in our view, impermissible because it assumes that any condition of use other than what is specified in the PMN can be reasonably foreseen, a view that is fundamentally inconsistent with the meaning of “reasonably foreseen conditions of use as determined by EPA.” Lautenberg requires that EPA identify and evaluate “reasonably foreseeable” conditions of use, not “all possible” conditions of use, however speculative, unlikely, or even whimsical they may be. Were EPA to view all possible conditions of use as “reasonably foreseeable,” EPA would fail to meet its obligation to determine “reasonably foreseen” conditions of use, which EPA is explicitly required to do under Lautenberg. This would also put EPA effectively in the position of making hazard-based determinations rather than the risk-based determinations that are supported by the plain language of Lautenberg.

Regulatory Burden of SNURs

We generally agree with the commenter that EPA must consider the effect of a SNUR on the new chemical substance. SNURs present burden to the entire supply chain and there is no doubt the issuance of a SNUR can lead to market deselection decisions. This is the essence of the “new chemical bias” in which new chemicals are regulated more stringently than existing chemicals that pose similar, if not greater, hazards, exposures, and risks. EPA can, and, in our view, should factor opportunities for reduced risk in its decision about risk management. Pollution prevention opportunities that arise from new chemicals relative to the hazards, exposures, and risks of the competing existing chemicals should be considered in EPA’s review and decisions. For example, petroleum distillates, as a class of substances, have well-understood hazards (e.g., flammability and aquatic toxicity) that are well-controlled. A very similar substance that is derived from biomass would not meet the definition of that substance as defined for purposes of TSCA because it is not derived from petroleum. If EPA reviews the biobased petroleum-equivalent and finds no difference in the expected hazards, releases, or exposures, EPA’s promulgation of a SNUR for that substance could significantly limit market acceptance of a more sustainable substance that does not present the global warming and hazard concerns associated with the extraction and production of distillates from petroleum. This way, EPA would not inadvertently forego market-based risk reduction opportunities presented by new chemicals with pollution prevention benefits while the similar “grandfathered” substances await prioritization. If and when EPA seeks to conduct risk evaluations on the incumbent existing chemicals (the petroleum-based substance) under Section 6, EPA can and should include the biobased equivalent in any risk evaluation and in considering risk management.

Worker Protection

Commenters state that in promulgating non-order SNURs without requiring protection in the workplace, EPA is failing to protect workers. We disagree. We agree with EPA that such cases cannot be considered “reasonably foreseeable” because worker protection is already required under standards and worker protection requirements imposed under the Occupational Safety and Health Act. Although violations of these standards are imaginable, according to an analysis of 40 years of violations issued by the Occupational Safety and Health Administration (OSHA), such violations of the basic PPE requirements are statistically uncommon. According to OSHA records, although there have been millions of violations asserted by OSHA, PPE violations such as glove and goggle non-use comprise less than one percent of recorded violations.