AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Final rule.

SUMMARY:

EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for 26 chemical substances which are the subject of premanufacture notices (PMNs) and deferring action on one chemical substance. The chemical substances are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. This action requires persons who intend to manufacture (defined by statute to include import) or process any of these 26 chemical substances for an activity that is designated as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.

DATES:

This rule is effective on November 18, 2019. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (e.s.t.) on October 2, 2019.

FOR FURTHER INFORMATION CONTACT:

 

For technical information contact: Kenneth Moss, Chemical Control Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-9232; email address: moss.kenneth@epa.gov.

For general information contact: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this rule on or after October 18, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

II. Background

A. What action is the Agency taking?

EPA is finalizing these SNURs under TSCA section 5(a)(2) for 26 substances which were the subject of PMNs. These SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. EPA is not finalizing the proposed SNUR at 40 CFR 721.11082 on the chemical substance that is the subject of PMN P-16-543, because the Agency is currently reviewing data submitted in support of a request to modify the underlying TSCA 5(e) Order that forms the basis for the proposed SNUR.

In the Federal Register of August 17, 2018 (83 FR 41039) (FRL-9981-82), EPA proposed a SNUR for 27 chemical substances in 40 CFR part 721, subpart E and reopened the public comment period in the Federal Register of October 15, 2018 (83 FR 51911) (FRL-9984-69). This reopened comment period closed on October 30, 2018. A direct final rule was also published on August 17, 2018 (83 FR 40986) (9971-37) but withdrawn on October 11, 2018 (83 FR 51360) (9984-71) when EPA received notices of intent to submit adverse comments on these SNURs. More information on the specific chemical substances subject to this final rule can be found in the Federal Register documents proposing the SNUR. The record for the SNUR was established under docket ID number EPA-HQ-OPPT-2017-0414. That docket includes information considered by the Agency in developing the proposed and final rules.

EPA received public comments on the proposed rule. Those comments and EPA's responses are found in Unit IV.

B. What is the Agency's authority for taking this action?

Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)).

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. In the case of a determination other than not likely to present unreasonable risk, the applicable review period must also expire before manufacturing or processing for the new use may commence. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register, a statement of EPA's findings.

III. Significant New Use Determination

When the Agency issues an Order under TSCA section 5(e), TSCA section 5(f)(4) requires that the Agency consider whether to promulgate a SNUR for any use not conforming to the restrictions of the Order or publish a statement describing the reasons for not initiating the rulemaking. Section 5(a)(2) of TSCA states that 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.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.

IV. Public Comments on Proposed Rule and EPA Responses

EPA received public comments from 12 entities on the proposed rule. The Agency's responses are described in this unit.

A. Anonymous Comments

Comment. EPA received two anonymous comments on the proposed rule. One of these comments was general in nature and did not pertain to the proposed rule.

Response: No response is required. The second anonymous comment—also repeated by another commenter—related to the proposed SNUR for a chlorofluorocarbon (P-16-150, 40 CFR 721.11078). This will be covered separately in this unit, under the subheading: “Protection of groundwater and source water from CFC contamination”.

B. Chlorinated Paraffins (CPs)

EPA received comments from six entities related to the proposed SNURs for chlorinated paraffins (CPs): 40 CFR 721.11068 (P-12-277), 40 CFR 721.11069 (P-12-278), 40 CFR 721.11070 (P-12-280), 40 CFR 721.11071 (P-12-281), 40 CFR 721.11072 (P-12-282 and P-14-684), 40 CFR 721.11073 (P-12-283 and P-14-683), 40 CFR 721.11074 (P-12-284), 40 CFR 721.11075 (P-12-433), 40 CFR 721.11076 (P-12-453), and 40 CFR 721.11077 (P-12-505).

a. Ongoing Uses Under Old Chemical Abstract Service (CAS) Registry Numbers

Comment: The commenters stated that manufacturers of these chemicals are already engaging in ongoing uses; new CAS registry numbers have been given to chemicals already in use and these new CAS registry numbers take time to be shared downstream and for companies to figure out if the SNUR substances are present in supply chains. The commenters add that CPs should be moved to TSCA section 6 (EPA's existing chemicals program) for a long-term regulatory remedy.

Response: The Agency is aware that CPs have been in commerce globally for over 70 years. However, in 2009, EPA informed the U.S. manufacturers of CPs that they were using the wrong CAS numbers for the CPs that are the subject of these SNURs. Those CPs were not properly listed on the TSCA Inventory, and thus remained “new chemical” substances as defined under TSCA. In 2012, the major domestic manufacturers and importers of CPs agreed to immediately cease domestic manufacture and import of short-chain CPs. Additionally, the companies agreed to submit PMNs for the medium-and long-chain CPs for EPA to review under TSCA section 5. Around the same time, EPA added medium- and long-chain CPs to the TSCA Work Plan for existing chemical substances. However, given that these CPs were not listed on the TSCA Inventory, EPA determined it was more appropriate to manage them under the TSCA New Chemicals Program. The CPs in this SNUR were subsequently reviewed under the New Chemicals Program, and the PMN submitters were held to certain restrictions in TSCA section 5(e) Orders. Consistent with its responsibilities under TSCA section 5(f)(4), EPA is finalizing these SNURs to ensure that other manufacturers, importers and processors of these CPs are held to the same standards as the original PMN submitters. EPA notes that suppliers have been on notice of this issue for over 10 years and would have an additional 5 years to come into compliance under the terms of this SNUR.

b. Production Time Limit (Five Years) in the SNUR

Comment: Several commenters said that five years was too short a time period by which to require SNUN notification, and that the short time period reignites market uncertainty on availability of these CPs. Commenters focused on the proposed time-based SNUR triggers and the potential negative impacts on the regulated community, including downstream processors and users of substances. The commenters encouraged EPA to clarify the obligations of manufacturers and processors of these substances under the SNURs, and the timeline for those obligations. The commenters also encouraged EPA to consider whether the SNURs could be revised to mitigate uncertainty for downstream users. One commenter also asked if this time-based notification requirement applies even if the chemical is being used for the uses allowed under the SNUR.

Response: The five-year time-trigger notification requirement is consistent with the underlying TSCA section 5(e) Orders for the CPs. Processors (who are not also manufacturers/importers) are exempt from this notification requirement. A manufacturer (including importer) of the CPs subject to the SNURs has five years following their commencement of manufacture to submit a SNUN . This SNUR ensures that the PMN submitters and other entrants to the marketplace are treated uniformly. The TSCA 5(e) Orders limit the submitters to a five-year production limit. Following the effective date of the SNUR, there will be ample time for other manufacturers (those not currently subject to the TSCA section 5(e) Orders) to submit SNUNs and for the Agency to complete its review. If an entity decides to discontinue manufacture within that five-year period, there is no need for a SNUN submission requesting to go beyond that time limit. The time limit is independent of the specific use restrictions; notification is required within that five-year period even if the chemical is manufactured for an allowed end use.

Separately, in response to a comment on another batch SNUR (public docket OPPT-2017-0366), to avoid confusion EPA is modifying the proposed SNUR to eliminate specific reference to 40 CFR 721.80 requirements and instead stating the significant new use in plain English: “It is a significant new use to manufacture (including import) the substance more than five years.”

c. Processors and Users SNUN Obligations

Comment: A commenter asked if processors or users who want to use a substance for uses other than those allowed under the SNUR must submit a SNUN for that use.

Response: Only manufacturers and processors are subject to SNUR notification requirements. A processor can either co-submit a SNUN with a manufacturer for the new use (an actual use, not the production limit, which applies only to manufacturers) or submit a SNUN on their own. After review of a SNUN, if EPA makes a finding allowing the significant new use, the submitter can engage in that new use but must wait for the SNUR to be modified accordingly before distributing the substance for the new use.

d. Downstream Notification

Comment: A commenter asked if, pursuant to 40 CFR 721.5, notification of downstream customers and processors of the existence of the SNUR is required prior to expiration of the 5-year time production limit or only after submission of a SNUN to exceed that limit.

Response: The downstream notification requirements at 40 CFR 721.5 are in force without regard to the specific SNUR requirements once the SNUR is effective and continues until the SNUR is revoked.

e. Use Not Currently Allowed in SNUR

Comment: One commenter stated that the uses allowed under the SNUR for the CP submitted as PMN P-12-277 (40 CFR 721.11068) would hinder the ability to use the substance for a certain confidential (adhesives) use that is currently ongoing.

Response: Because this is an ongoing use, EPA has revised the regulatory text of the SNUR at 40 CFR 721.11068 to add this use to those currently allowed uses in the proposed SNUR.

f. Too Little Time To Switch to Alternatives to CPs

Comment: One commenter claims that industry may be using the CP substances subject to the SNUR for critical uses without alternatives, but with the short timeframe for comments and the lack of clarity surrounding the assignment of the CAS registry numbers, we have not been able to ascertain our uses. In the cases that alternatives may exist, transition takes beyond five years to qualify, certify, and implement. There is also the challenge of finding substances with an equivalent technical performance and proliferation within a complex supply base.

Response: The Agency notes that companies have been on notice since 2009 that EPA has been taking actions to regulate these chemical substances. As stated previously, EPA has publicly documented its concerns over these chemicals through multiple actions taken over the last decade: By initiating the enforcement action in 2009, publishing an “Action Plan” in 2009, reaching legal settlements with the manufacturers in 2012, initiating the TSCA section 5 process in 2012, listing the chemicals on the 2012 Work Plan, and publishing risk assessments in 2015 that identified environmental concerns. There is, therefore, no basis for EPA to further extend the five-year timeline in the proposed SNURs.

C. Isocyanates

Comment: One commenter stated that—generally for isocyanate SNURs, but in this rule specifically the proposed SNUR for PMN P-17-10 (721.11084), in which EPA proposed that exceeding the specified weight of residual isocyanates in the PMN chemical substance would be a significant new use—EPA should clarify the extent it is basing the SNUR on concerns with excess or residual isocyanate monomers. EPA appears to be basing the proposed SNURs on the potential for the hazards or risks of excess or residual isocyanate monomer in mixture with this isocyanate-based polymer or prepolymer. These isocyanate monomers are existing chemicals with many ongoing uses, including use as a monomer or use in excess or residual monomer. EPA has not transparently identified those monomers as being subject to the proposed SNURs. EPA may not use its SNUR authority to address ongoing uses of the isocyanate monomers.

In response to this commenter, another commenter stated that regardless of whether there are separate ongoing uses for these isocyanates, their presence here as residuals is directly associated with the manufacture of a new chemical substance that EPA has reviewed and for which it has determined that the PMN substance may present an unreasonable risk. That commenter continued that it is therefore appropriate in this and other such cases that EPA promulgates SNURs that would require notification and EPA review of potential risks posed by the residual isocyanates present in the PMN substance prior to allowing expanded manufacture or use. In addition, the commenter states that these isocyanates have never been used to produce the PMN substance before; this particular significant new use identified by EPA—i.e., manufacture of the PMN substance with a residual isocyanate level above 0.1%—would constitute a significant new use of both the relevant isocyanates and the PMN substance requiring notification under TSCA section 5.

Response: EPA is concerned about the health effects of any residual monomer as well as unreacted isocyanate groups on a polymer when assessing the risks for the new chemical substances. EPA has the authority under TSCA section 5 to address any risks associated with the manufacture, processing, and use of the new chemical substances even if those risks are based on the presence of existing chemical substances. The SNUR only applies to activities associated with the new chemical substances. Activities associated with the new chemical substance are not ongoing activities of the existing chemical substance. EPA did not receive specific, quantitative information that demonstrates the chemical substance subject to these proposed SNURs exhibit a lower potential for the hazards and potential risks described in the proposed SNUR or that they will specifically replace a chemical substance with a higher potential for hazards and risks. EPA is issuing the SNUR as proposed to provide the Agency with the opportunity to review any new uses for potential unreasonable risks. As described in the Agency's ongoing Action Plan for MDI and TDI, diisocyanates are well-known dermal and inhalation sensitizers in the workplace and have been documented to cause asthma, lung damage, and in severe cases, fatal reactions. EPA is concerned about potential health effects that may result from exposures of consumers or self-employed workers while using products containing uncured (unreacted) MDI and TDI and its related polyisocyanates (e.g., spray-applied foam sealants, adhesives, and coatings) or incidental exposures to the general population while such products are used in or around buildings including homes or schools. While workers may already be using protective controls in occupational settings, due to the nature of the potential risk posed by these chemicals, EPA believes it is prudent to emphasize its concern through respiratory protection requirements where there is potential for inhalation exposure, in addition to proposing significant new uses such as consumer use and application method. Accordingly, the regulatory actions for new diisocyanates reflects EPA's policy of consistent treatment of the entire class of potentially hazardous chemicals, regardless of their statutory status as “new” or “existing” chemicals.

Comment: One commenter stated that EPA should clarify the basis, scope, and provisions of the proposed SNURs. In particular, EPA should clarify its basis for both the imposed limitations on residual isocyanates and molecular weight limitations. In addition, the commenter added that EPA should defer personal protective equipment (PPE) and hazard communication provisions to the applicable OSHA requirements.

Response: With regards to the basis for imposed limitations on residual isocyanates and molecular weight limitations, for each PMN substance such as P-17-10 where there is potential risk from residual chemicals or lower molecular weights if the polymer is manufactured differently, EPA attempts to minimize exposure based on information in the notification about how the chemical is manufactured. The PMN for P-17-10 contained information that the polymer was manufactured at a certain molecular weight and residual isocyanate level less than 0.1%. EPA included these as restrictions in the TSCA section 5(e) Order and the proposed SNUR to prevent potential health risks. Regarding deferring PPE and hazard communication requirements to OSHA, because the TSCA section 5(e) Orders for the chemicals in this SNUR contain worker protection requirements, EPA proposed and is issuing a final SNUR retaining those requirements so that all manufacturers and processors are subject to the same requirements. If the underlying TSCA section 5(e) Orders are modified EPA would consider modifying the SNUR. For PMNs currently in review EPA will continue to determine when PPE and hazard communication provisions can be addressed by other applicable requirements or if a specific finding for a PMN requires PPE and hazard communication provisions under TSCA.

Comment: The same commenter states that EPA should also clarify the proposed regulatory text and the preamble of the proposed SNURs, which include inconsistent language regarding when respiratory and dermal protection is needed.

Response: The regulatory text for 40 CFR 721.63 states that workers who are “reasonably likely to be exposed” are required to use the personal protective equipment identified in the SNUR. The preamble language is a summary of SNUR requirements and is not intended to describe every detail of the SNUR requirements. Persons manufacturing or processing a chemical substance subject to a SNUR should follow the requirements cited in the regulatory text of the SNUR.

Comment: The same commenter stated that EPA should delete the provisions incorporating the recordkeeping requirements in 40 CFR 721.125, as it did in the proposed TDI SNUR, 80 FR 2068 (Jan. 15, 2015), and some others.

Response: The SNURs cited by the commenter are existing chemical SNURs where EPA determined recordkeeping was not needed. For example, when the significant new use for an existing chemical is “any use” there is typically no recordkeeping required because there are no records to be maintained that would inform EPA inspection or enforcement. Because these are new chemical SNURs EPA will continue to require recordkeeping for all new chemical SNUR to better allow EPA to inspect and enforce SNUR requirements at facilities where chemicals subject to SNURs are manufactured and processed.

D. Deviation From EPA's PBT Policy

Comment: One commenter stated that EPA has deviated from its Persistent, Bioaccumulative, and Toxic (PBT) New Chemical Substances Testing Policy (see final policy statement at 64 FR 60194; November 4, 1999) and failed to explain those deviations. Comments relate to the previously mentioned CPs, plus two other chemicals (P-17-228, 40 CFR 721.11092) and P-17-229, 40 CFR 721.11093).

Response: The policy statement, which is not a rule and accordingly has no binding effect, provides guidance criteria for persistence, bioaccumulation, and toxicity for new chemicals and advises the industry about our regulatory approach for chemicals meeting the criteria. Establishment of a PBT category alerts potential PMN submitters to possible assessment or regulatory issues associated with PBT new chemicals review. It also provides a vehicle by which the Agency may gauge the flow of PBT chemical substances through the TSCA New Chemicals Program and measure the results of its risk screening and risk management activities for PBT new chemical substances; as such, it is a major element in the Agency's overall strategy to further reduce risks from PBT pollutants.

The TSCA section 5(e) Orders for the CPs do state that at least some congener groups present in the PMN substances may be “persistent to very persistent, with estimated half-lives in air exceeding 2 days and estimated half-lives in water or sediments exceeding 2 months” and “bioaccumulative to very bioaccumulative based on multiple lines of evidence, including: Log Kow values, modeled BCFs, laboratory-measured BCFs, field-measured BAFs, field-measured BMFs, laboratory-measured biota-sediment bioaccumulation factors (BSAFs) and the presence of MCCPs in human and wildlife biota.” The TSCA section 5(e) Order for the other two substances (P-17-228, 40 CFR 721.11092 and P-17-229, 40 CFR 721.11093), identifies PBT concerns as well, based on physical chemical properties of those substances. The policy statement notes that even for “very” P and “very” B cases, where “because of the increased concern, more stringent control action would be a likely outcome, . . . it would not be appropriate to automatically trigger a “ban pending testing” at these cutoffs given the uncertainties about substance properties, release, and environmental behavior that normally characterize PMN review.” Accordingly, the Agency evaluates each PMN based on the use, exposure and release information submitted, and makes a case by case risk management decision. In fact, the TSCA section 5(e) Orders for the CPs state that EPA has determined that because medium-chain CPs similar to the PMN substances have been manufactured, processed and used for the uses described in the PMN for more than 40 years, manufacture, processing, distribution in commerce, use and disposal of the PMN substances in accordance with the provisions of the TSCA section 5(e) order do not create an unreasonable risk of injury to health or the environment. The proposed SNUR terms for the CPs and the other 2 substances (P-17-228, 40 CFR 721.11092; and P-17-229, 40 CFR 721.11093) reflect the Agency's determination under their respective TSCA section 5(e) Orders, that the controls stipulated in the underlying TSCA section 5(e) Orders are protective or human health and environment, pending submission of further information that is identified in the TSCA section 5(e) Orders.

E. EPA Must Ensure That the Docket Is Complete

Comment: One commenter stated that the TSCA section 5(e) Order and Risk Assessment for the CP PMNs P-14-683 and P-14-684, plus the testing strategy for all the CP PMNs included in a previous docket, are not in the docket for this SNUR.

Response: This is an oversight. The TSCA section 5(e) Order and risk assessment for P-14-683 and P-14-684 have now been added to the docket. Note, however, that the chemical identities, risk assessment, and terms of the TSCA section 5(e) Order are identical to those for P-12-283 and P-12-282, respectively, which are already in the docket. As a result, EPA has not reopened the public comment period, because the public had an opportunity to review the available risk assessment and TSCA section 5(e) Order requirements that apply to P-16-683 and P-14-684. Each CP PMN 5(e) Order contains the current iteration of the testing strategy as specific testing requirements required by a certain date. EPA refers the public to the docket for the December 23, 2015 (80 FR 79886) “Chlorinated Paraffins; Request for Available Information on PMN Risk Assessments” (EPA-HQ-OPPT-2015-0789) for the original testing strategy for CPs.

F. Consistency Between Orders and SNURs: Hierarchy of Controls

Comment: One commenter stated that the provisions in many of the proposed SNURs that address “protection in the workplace” are not consistent with the underlying TSCA section 5(e) Orders, and unlike the TSCA section 5(e) Orders, do not accurately and sufficiently invoke the Industrial Hygiene Hierarchy of Controls (HOC), which is a foundational element of OSHA and NIOSH policy. The commenter referred to this language generally used in TSCA section 5(e) Orders: “Engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible to each person who is reasonably likely to be [dermally exposed/exposed by inhalation] in the work area to the PMN substance . . . Where engineering, work practice, and administrative controls are not feasible or, if feasible, do not prevent exposure, each person subject to this exposure must be provided with, and is required to wear, [personal protective    equipment] . . .” The corresponding SNUR language is shortened to this: “engineering control measures (e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures (e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible”.

Response: Although the SNURs may not precisely mimic the language in the underlying TSCA section 5(e) Orders, the SNURs do incorporate the same requirements for HOC as found in the TSCA section 5(e) Orders. The language in the specific references under 40 CFR 721.63(a) regarding establishing a program to protect workers incorporates both the HOC and worker protection requirements of the SNUR. The requirements are identical between the TSCA section 5(e) Orders and SNURs. Adding a phrase referring to PPE where engineering controls are not feasible would not serve to further clarify this SNUR notification requirement.

G. Other Inconsistencies Between Orders and SNURs

Comment: A commenter noted the following inconsistencies between certain proposed SNUR and underlying TSCA section 5(e) Order restrictions. For P-17-218, the TSCA section 5(e) Order requires that the substance not be manufactured or processed “involving a method that generates a vapor, mist, aerosol, or dust,” whereas the proposed SNUR does not contain the same restrictions, and rather only has an analogous restriction regarding the use of the PMN substance. For P-17-154, the TSCA section 5(e) Order calls for chemical goggles or equivalent eye protection, while the SNUR does not. For the CP PMNs, the TSCA section 5(e) Orders state that the 5-year time limit is on manufacturing, processing, distribution in commerce, use, and disposal, while the proposed SNUR simply states it is a limit on manufacturing.

Response: For the SNUR for P-17-218, the Agency agrees that there was an oversight in the proposed rule. The final SNUR for that chemical substance no longer cites 40 CFR 721.80(y)(1) and (2), but rather include the overarching statement “It is a significant new use to manufacture, process or use the substance involving a method that generates a vapor, mist, aerosol, or dust.” For the SNUR for P-17-154, the Agency agrees that there was an oversight in the proposed rule. The final SNUR for that chemical substance will include the restriction found at 40 CFR 721.63(a)(2)(iii), which corresponds to chemical goggles or equivalent eye protection. For the CP PMNs, even though the 5-year time limit in the TSCA section 5(e) Order prohibited manufacture, processing, distribution in commerce, use, and disposal for the Company submitting the PMN, EPA's previous practice for all other SNURS and intent for these SNURs was not to prohibit activities other than manufacturing by other entities based on a testing requirement for manufacturers. The SNUR requirement will continue to apply only to manufacturers or importers.

H. Typographical Error in the Proposed SNUR Preamble

Comment: A commenter notes that the preamble to the proposed SNUR for P-16-543 lists one of the TSCA section 5(e) Order restrictions as “Manufacture, process, or use of the substance without the engineering controls required by the Order to control dermal and inhalation exposure,” where it should say “No manufacture . . . etc.”

Response: The Agency is deferring final action on this SNUR due to ongoing review of data to support a modification to the underlying TSCA 5(e) Order that forms to basis for the SNUR.

I. Incomplete Listing of Engineering Controls

Comment: A commenter noted that the preamble to the SNUR for P-17-226 has an incomplete listing of engineering controls contained in the underlying TSCA section 5(e) Order. In particular, bullet 5 in the preamble states “No processing without appropriate engineering controls to prevent inhalation exposure, including dust removal with 99.9% efficiency when loading or unloading the substance in powder form.”

Response: The referenced bullet 5 is the only TSCA section 5(e) Order requirement regarding engineering controls. The SNUR and preamble will remain as proposed.

J. Protection in the Workplace Provisions

Comment: A commenter suggested that EPA should add provisions addressing protection in the workplace to proposed SNURs that currently do not—and the underlying TSCA section 5(e) Orders do not—include any such provision. The commenter also states that EPA should not defer workplace protections to OSHA or NIOSH.

Response: EPA disagrees with the comment that, with respect to scenarios where EPA expects that worker protection requirements under other federal/state authorities would mitigate risks to workers, EPA must designate all uses without those protections as “significant new uses”. As discussed in a previous response to comment, because the TSCA section 5(e) Orders for the chemicals in this SNUR contain certain requirements to address unreasonable risks, EPA proposed and is issuing a final SNUR retaining the same requirements so that all manufacturers and processors are subject to similar requirements. If the underlying TSCA section 5(e) Orders are modified to include worker protection requirements, EPA would consider modifying the SNUR. When exercising its discretion regarding which new uses should be designated as significant under TSCA 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 expects that employers will require and workers will use the appropriate controls (e.g., personal protective equipment such as impervious gloves and/or respirators), consistent with the Safety Data Sheet prepared by the PMN submitter, in a manner adequate to protect them.

K. EPA Needs To Add Limits on Water Releases in Three of the SNURs

Comment: One commenter noted that the proposed SNURs for P-17-154, P-17-155, and P-17-156 contain no limits on water releases, even though the underlying TSCA section 5(e) Order for these chemical substances mention an aquatic toxicity Concentration of Concern (CoC) of 240 ppb. By comparison, another proposed rule (P-17-226, 721.11091) does contain a surface water limit of the same amount.

Response: Based on review of the available information available for these four PMNs, the Agency made different determinations. While the hazards for the PMN substances that the commenter compared are similar, their predicted environmental fate was not. EPA estimates for removal during wastewater treatment for P-17-154, P-17-155, and P-17-156 was 90%. Wastewater treatment removal for the reaction products of P-17-226 during wastewater treatment was estimated to be as low as 0% and to contain some chemical components that are very persistent and bioaccumulative. Based on this information EPA decided to include a surface water limit for P-17-226 but not for P-17-154, P-17-155, and P-17-156.

L. Protection of Groundwater and Source Water From CFC Contamination

Comment: Two commenters—one anonymous—raised concerns related to the proposed SNUR for a substance generically described as “chlorofluorocarbon” (P-16-150, 40 CFR 721.11078), which includes proposed significant new uses involving workplace protection, restriction to use as a chemical intermediate and a water discharge limit. The commenters suggested that chlorofluorocarbons (CFCs) in general should not be approved under SNURs, as CFCs already contaminates certain groundwater drinking water supplies, which increases the costs and difficulty to remove this containment to provide safe drinking water, and there are potential health problems and future environmental issues.

Response: EPA's review of this chemical did identify potential for health and environmental effects if this chemical is limited to certain concentrations in surface waters or drinking water. EPA's assessment of the chemical as an intermediate only identified limited releases to air after incineration and water releases to surface waters after wastewater treatment. These releases would be significantly below any levels of concern for health and environmental effects for the chemical. Because of the potential hazards, the TSCA section 5(e) Order did not allow, and the SNUR contains reporting requirements before, levels in surface waters exceed 240 ppb or any use of the chemical other than as a chemical intermediate. EPA would receive notification of and evaluate any new uses of the chemical that could result in releases causing health and environmental effects.

M. Modification of One Order and Associated SNUR

Subsequent to the publication of the proposed SNUR for P-16-410 (721.11080), the PMN submitter requested a modification to the underlying TSCA section 5(e) Order to increase the allowable percent concentration of the PMN substance from 0.2% to 23% as an automotive engine fluid additive in imported product formulations for industrial use only. EPA evaluated the information submitted by the PMN submitter and determined that increasing the concentration of the PMN substance in imported product to 23% will not result in risk to workers or consumers. As a result, EPA modified the TSCA section 5(e) Order to allow this increase in percent concentration and has accordingly modified that provision in the associated final SNUR.

V. Substances Subject to This Rule

EPA is establishing significant new use and recordkeeping requirements for 26 chemical substances in 40 CFR part 721, subpart E. In Unit IV of the original direct final rule in the Federal Register of August 17, 2018 (83 FR 40986), EPA provides the following information for each chemical substance:

• PMN number.
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).
• Basis for the TSCA section 5(e) Order.
• Potentially Useful Information. This is information identified by EPA that would help characterize the potential health and/or environmental effects of the chemical substance in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use designated by the SNUR.
• CFR citation assigned in the regulatory text section of this rule.

The regulatory text section of each rule specifies the activities designated as significant new uses. Certain new uses, including exceedance of production volume limits (i.e., limits on manufacture volume) and other uses designated in this rule, may be claimed as CBI. Unit IX. discusses a procedure companies may use to ascertain whether a proposed use constitutes a significant new use.

These final rules include 26 PMN substances that are subject to Orders under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying Orders, consistent with TSCA section 5(f)(4).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA section 5(e) Order usually requires, among other things, that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL) that is established by EPA to provide adequate protection to human health. In addition to the actual NCEL concentration, the comprehensive NCELs provisions in TSCA section 5(e) Orders, which are modeled after Occupational Safety and Health Administration (OSHA) Permissible Exposure Limits (PELs) provisions, include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. However, no comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA section 5(e) Order for the same chemical substance.

VI. Rationale and Objectives of the Rule

A. Rationale

During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for all 26 chemical substances regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV of the original direct final rule in the Federal Register of August 17, 2018 (83 FR 40986). Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow TSCA section 5(e) Orders with a SNUR that identifies the absence of those protective measures as Significant New Uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.

B. Objectives

EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:

• To receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.
• To have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• To be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.
• To identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA section 5(e) Orders, consistent with TSCA section 5(f)(4).

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at http://www.epa.gov/​opptintr/​existingchemicals/​pubs/​tscainventory/​index.html.

VII. Applicability of the Significant New Use Designation

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. However, TSCA section 5(e) Orders have been issued for all of the chemical substances, and the PMN submitters are prohibited by the TSCA section 5(e) Orders from undertaking activities which will be designated as significant new uses. The identities of 12 of the 26 chemical substances subject to this final rule have been claimed as confidential and EPA has received one post-PMN bona fide submission (per 40 CFR 720.25 and 721.11) for a chemical substance covered by this action. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this rule are ongoing.

EPA designated August 17, 2018 (the date of publication of the direct final and proposed rules in the Federal Register) as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach has been to ensure that a person could not defeat a SNUR by initiating a significant new use before the effective date of the final rule.

In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of August 17, 2018, that person will have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons will have to first comply with all applicable SNUR notification requirements and wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

VIII. Development and Submission of Information

EPA recognizes that TSCA section 5 does not require developing any particular new information (e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV of the original direct final rule in the Federal Register of August 17, 2018 (83 FR 40986) lists potentially useful information for all SNURs listed here. Descriptions of this information is provided for informational purposes. The potentially useful information identified in Unit IV of the original direct final rule will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use. Companies who are considering submitting a SNUN are encouraged, but not required, to develop the information on the substance, which may assist with EPA's analysis of the SNUN.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h).

In certain of the TSCA section 5(e) Orders for the chemical substances regulated under this rule, EPA has established production volume limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. The SNURs contain the same production volume limits as the TSCA section 5(e) Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the production limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

Any request by EPA for the triggered and pended testing described in the TSCA section 5(e) Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of 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.

The potentially useful information identified in Unit IV. of the original direct final rule may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information on the following:

• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

IX. Procedural Determinations

By this rule, EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.1725(b)(1).

Under these procedures a manufacturer or processor may request EPA to determine whether a proposed use would be a significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance and must identify the specific use for which it intends to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.1725(b)(1) with that under 40 CFR 721.11 into a single step.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

X. SNUN Submissions

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at http://www.epa.gov/​opptintr/​newchems.

XI. Economic Analysis

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2017-0414.

XII. Statutory and Executive Order Reviews

A. Executive Order 12866

This action establishes SNURs for several new chemical substances that were the subject of PMNs and TSCA section 5(e) Orders. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “ Regulatory Planning and Review” (58 FR 51735, October 4, 1993).

B. Paperwork Reduction Act (PRA)

According to PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable. EPA is amending the table in 40 CFR part 9 to list the OMB approval number for the information collection requirements contained in this action. This listing of the OMB control numbers and their subsequent codification in the CFR satisfies the display requirements of PRA and OMB's implementing regulations at 5 CFR part 1320. This Information Collection Request (ICR) was previously subject to public notice and comment prior to OMB approval, and given the technical nature of the table, EPA finds that further notice and comment to amend it is unnecessary. As a result, EPA finds that there is “good cause” under section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 553(b)(3)(B)) to amend this table without further notice and comment.

The information collection requirements related to this action have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

Pursuant to RFA section 605(b), 5 U.S.C. 601 et seq., the Agency hereby certifies that promulgation of this SNUR will not have a significant adverse economic impact on a substantial number of small entities. The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, it appears that no small or large entities presently engage in such activities. A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this SNUR are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that final SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

D. Unfunded Mandates Reform Act (UMRA)

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).

E. Executive Order 13132

This action will not have a substantial direct effect on 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, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).

F. Executive Order 13175

This action does not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action does not significantly nor uniquely affect the communities of Indian Tribal governments, nor does it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this action.

G. Executive Order 13045

This action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

H. Executive Order 13211

This action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this action is not expected to affect energy supply, distribution, or use and because this action is not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act (NTTAA)

In addition, since this action does not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to this action.

J. Executive Order 12898

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).

XIII. Congressional Review Act

Pursuant to the CRA (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

List of Subjects

40 CFR Part 9

• Environmental protection
• Reporting and recordkeeping requirements

40 CFR Part 721

• Environmental protection
• Chemicals
• Hazardous substances
• Reporting and recordkeeping requirements

Therefore, 40 CFR parts 9 and 721 are amended as follows:

PART 9—[AMENDED]

1. The authority citation for part 9 continues to read as follows:

Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003, 2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33 U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330, 1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR, 1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g, 300g-1, 300G-2, 300G-3, 300G-4, 300G-5, 300G-6, 300J-1, 300J-2, 300J-3, 300J-4, 300J-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542, 9601-9657, 11023, 11048.

2. In § 9.1, add t§§ 721.11068 through 721.11094 in numerical order under the undesignated center heading “Significant New Uses of Chemical Substances” to read as follows:

PART 721—[AMENDED]

3. The authority citation for part 721 continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and 2625(c).

4. Add §§ 721.11068 through 721.11094 to subpart E to read as follows:

Subpart E—Significant New Uses for Specific Chemical Substances