Table of Contents I. Introduction A. Authority and Background B. Rulemaking History II. Request for Information A. Scope and Definition B. Test Procedure C. Industry Test Method Harmonization D. Standby Energy Use E. Other Test Procedure Topics III. Submission of Comments I. Introduction

ACIM are included in the list of “covered products” for which DOE is authorized to establish and amend energy conservation standards and test procedures. (42 U.S.C. 6311(1)(F)) DOE's test procedure for ACIM is prescribed at 10 CFR 431.134. The following sections discuss DOE's authority to establish and amend the test procedure for ACIM, as well as relevant background information regarding DOE's consideration of test procedures for this equipment.

The Energy Policy and Conservation Act of 1975, as amended (“EPCA”), Public Law 94-163 (42 U.S.C. 6291-6317, as codified), among other things, authorizes DOE to regulate the energy efficiency of a number of consumer products and certain industrial equipment. 1 Title III, Part C of EPCA established the Energy Conservation Program for Certain Industrial Equipment, which sets forth a variety of provisions designed to improve energy efficiency. 2 This equipment includes ACIM, the subject of this RFI. (42 U.S.C. 6311(1)(F))

Under EPCA, DOE's energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Federal testing requirements consist of test procedures that manufacturers of covered equipment must use as the basis for: (1) Certifying to DOE that their equipment complies with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6316(a); 42 U.S.C. 6295(s)), and (2) making representations about the efficiency of that equipment (42 U.S.C. 6314(d)). Similarly, DOE must use these test procedures to determine whether the equipment complies with relevant standards promulgated under EPCA. (42 U.S.C. 6316(a); 42 U.S.C. 6295(s))

Under 42 U.S.C. 6314, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered equipment. EPCA requires that any test procedures prescribed or amended under this section must be reasonably designed to produce test results which reflect energy efficiency, energy use or estimated annual operating cost of a given type of covered equipment during a representative average use cycle and requires that test procedures not be unduly burdensome to conduct. (42 U.S.C. 6314(a)(2))

EPCA also requires that, at least once every 7 years, DOE evaluate the test procedures for each type of covered equipment, including ACIM, to determine whether amended test procedures would more accurately or fully comply with the requirements for test procedures not to be unduly burdensome to conduct and be reasonably designed to produce test results that reflect energy efficiency, energy use, and estimated operating costs during a representative average use cycle. (42 U.S.C. 6314(a)(1)) In addition, if the Secretary determines that a test procedure amendment is warranted, the Secretary must publish proposed test procedures in the Federal Register , and afford interested persons an opportunity (of not less than 45 days' duration) to present oral and written data, views, and arguments on the proposed test procedures. (42 U.S.C. 6314(b)) If DOE determines that test procedure revisions are not appropriate, DOE must publish its determination not to amend the test procedures. DOE is publishing this RFI to collect data and information to inform its decision in satisfaction of the 7-year review requirement specified in EPCA. (42 U.S.C. 6314(a)(1))

EPCA prescribed the first Federal test procedure for ice makers, directing that the ACIM test procedure is the Air-Conditioning, Heating, and Refrigeration Institute (AHRI) Standard 810-2003, “Performance Rating of Automatic Commercial Ice-Makers.” (42 U.S.C. 6314(a)(7)(A)) EPCA further stipulated that if AHRI 810-2003 was revised, DOE must amend the DOE test procedure as necessary to be consistent with the amended AHRI Standard unless DOE determines, by rule and supported by clear and convincing evidence, that to do so would not meet the requirements for test procedures set forth in EPCA. (42 U.S.C. 6314(a)(7)(B)) If DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6314(b))

Pursuant to these provisions, on December 8, 2006, DOE published a final rule (“the 2006 en masse final rule”) that, among other things, adopted the test procedure specified in AHRI Standard 810-2003 as the Federal test procedure for ice makers. 71 FR 71339. DOE also adopted a clarified energy use rate equation to specify that energy use be calculated using the entire mass of ice produced during the testing period, normalized to 100 pounds of ice produced. Id. at 71 FR 71350. The DOE test procedure also incorporated by reference the American National Standards Institute (“ANSI”)/American Society of Heating, Refrigerating and Air-Conditioning Engineers (“ASHRAE”) Standard 29-1988 (Reaffirmed 2005) (“ASHRAE Standard 29-1988 (RA 2005)”), “Method of Testing Automatic Ice Makers,” as the method of testing. The 2006 en masse final rule preamble stated that the adopted test procedure was applicable to ACIM that produce cube type ice with capacities between 50 and 2,500 lb/24 h. Id. at 71 FR 71351.

Subsequently, on January 11, 2012, DOE satisfied its statutory obligation under 42 U.S.C. 6314(a)(7)(B) to amend the ACIM test procedure by incorporating by reference AHRI Standard 810-2007 with Addendum 1 “2007 Standard for Performance Rating of Automatic Commercial Ice Makers” (“AHRI 810-2007”) and ANSI/ASHRAE Standard 29-2009 “Method of Testing Automatic Ice Makers,” (including Errata Sheets issued April 8, 2010 and April 21, 2010), approved January 28, 2009 (“ASHRAE 29-2009”). 77 FR 1591 (“January 2012 ACIM TP final rule”). Consistent with the statutory definition of ACIM and the updated AHRI 810-2007, the amended DOE test procedure expanded the scope of the test procedure to include equipment with capacities from 50 to 4,000 lb/24 h. The updated DOE test procedure also (1) provided test methods for continuous type ice makers and batch type ice makers that produce other than cube type ice, (2) standardized the measurement of energy and water use for continuous type ice makers with respect to ice hardness, (3) clarified the test method and reporting requirements for remote condensing automatic commercial ice makers designed for connection to remote compressor racks, and (4) discontinued the use of a clarified energy use rate calculation to instead reference the calculation of energy use per 100 pounds of ice as specified in ASHRAE 29-2009. Id. The amended test procedure became mandatory for equipment testing beginning on January 7, 2013. Id.

In the following sections, DOE has identified a variety of issues on which it seeks input to aid in the development of the technical and economic analyses regarding whether amended test procedures for ACIM would more accurately or fully comply with the requirements in EPCA that test procedures: (1) Be reasonably designed to produce test results which reflect energy use during a representative average use cycle, and (2) not be unduly burdensome to conduct. (42 U.S.C. 6314(a)(2)) Specifically, DOE is requesting comment on any opportunities to streamline and simplify testing requirements for ACIM.

Additionally, DOE welcomes comments on other issues relevant to the conduct of this process that may not specifically be identified in this document. In particular, DOE notes that under Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs,” Executive Branch agencies such as DOE are directed to manage the costs associated with the imposition of expenditures required to comply with Federal regulations. 82 FR 9339 (Feb. 3, 2017). Consistent with that Executive Order, DOE encourages the public to provide input on measures DOE could take to lower the cost of its regulations applicable to ACIM consistent with the requirements of EPCA.

DOE defines an automatic commercial ice maker as a factory-made assembly (not necessarily shipped in one package) that (1) consists of a condensing unit and ice-making section operating as an integrated unit, with means for making and harvesting ice; and (2) may include means for storing ice, dispensing ice, or storing and dispensing ice. 10 CFR 431.132.

A modulating capacity ice maker is one designed to be capable of operating at multiple capacity levels. This modulation presumably could be accomplished by using a single compressor with multiple or variable capacity, using multiple compressors, or in some other manner. In the January 2012 ACIM TP final rule, DOE did not set a test method for measuring the energy use or water consumption of automatic commercial ice makers that are capable of operating at multiple capacities. 77 FR 1591, 1601-1602 (Jan. 11, 2012). The decision to exclude modulating capacity ice makers was based on the lack of existing automatic commercial ice makers with modulating capacity, as well as limited information regarding how such equipment would function. At this time, DOE is unaware of any such products that are currently available in the market. DOE is interested in whether modulating capacity ice makers are currently sold in the market and, if so, the design characteristics, operation, and testing of such equipment.

Issue 1: DOE requests comment on whether any modulating capacity ice makers are currently available in the market. If such products are currently available, DOE requests information on how such equipment functions, such as typical capacity ranges and the relative frequency of use at different capacity ranges, and how such equipment is currently tested.

In accordance with the review process under 42 U.S.C. 6314(a)(1)(A), DOE has determined the test procedure potentially could be improved by modifying some of its provisions to more accurately or fully comply with the requirements in EPCA that a test procedure be reasonably designed to reflect energy use during a representative average use cycle and not be unduly burdensome to conduct.

The existing DOE ACIM test procedure incorporates by reference AHRI 810-2007, which refers to test methods in ASHRAE Standard 29. The DOE test procedure additionally specifies that references to ASHRAE 29 in AHRI 810-2007 refer to ASHRAE 29-2009. 3 10 CFR 431.134(b).

Since publication of the January 2012 ACIM TP final rule, both AHRI and ASHRAE have published new versions of the referenced standards. The most recent versions are AHRI 810-2016 and ASHRAE 29-2015. DOE has reviewed the most recent versions of both AHRI 810 and ASHRAE 29 and has compared the updated versions of these industry standards to those currently incorporated by reference in the ACIM test procedure. The updates published in ASHRAE 29-2015 provide additional specificity to several aspects of the test method. In general, DOE has tentatively determined that these updates increase the precision and improve the repeatability of the test method, but do not fundamentally change the testing process, ambient test conditions, or test results. In addition, ASHRAE made several grammatical, editorial, and formatting changes to improve the clarity of the test method. DOE has tentatively determined that these changes would not affect how the test is conducted. Table II.1 summarizes the primary substantive changes between ASHRAE 29-2009 and ASHRAE 29-2015.

AHRI 810-2016 was also updated to include a definition, measurement, and reporting requirements for potable water use rate. These are discussed in more detail in section II.C.in this RFI. The other changes to AHRI 810-2016 are primarily clerical in nature, intended to provide greater consistency in the use of terms and specific definitions for those terms. The primary changes include updating the defined equipment varieties to be more consistent with DOE definitions, using the defined terms more consistently throughout the standard, and adding definitions for many of the reported quantities. AHRI 810-2016 also references the latest version of ASHRAE 29, ASHRAE 29-2015.

Based on DOE's review, the changes to AHRI 810-2016 and ASHRAE 29-2015 serve primarily to improve the consistency and specificity of the test procedure and would not fundamentally alter the test method or test parameters. As such, these updates would not result in a change to the measured energy consumption of covered equipment. DOE seeks comment and data on this preliminary determination.

Issue 2: DOE seeks comment on updating the DOE test procedure to incorporate by reference the latest industry standards: AHRI 810-2016 and ASHRAE 29-2015. Specifically, DOE requests comment on whether incorporating by reference these industry standards would more accurately reflect energy efficiency during a representative average use cycle or reduce testing burden. Additionally, DOE seeks comment on the benefits and burdens of adopting any industry/voluntary consensus-based or other appropriate test procedure, without modification.

DOE is aware of one aspect of ASHRAE 29 found in both the 2009 and 2015 versions that may need further instruction. For continuous type ACIM, the energy use and condenser water use are determined by multiplying the measured values by the ice hardness adjustment factor. The ice hardness factor is determined by following the procedure specified in the “Method of Calorimetry” in Normative Annex A of ANSI/ASHRAE 29-2009. Section A2 specifies that the calorimeter constant shall be no greater than 1.02. ASHRAE 29-2015 specifies that the calorimeter constant must be in the range of 1.0 to 1.02. DOE is aware that some third-party labs have had difficulty achieving the calorimeter constant requirements specified in ASHRAE 29-2009 (and therefore, also those specified in ASHRAE 29-2015). Amended instructions regarding the calorimeter constant may reduce testing burden while maintaining the accuracy of the test procedure.

Issue 3: DOE requests comment on whether further instruction is necessary to achieve the required calorimeter constant as specified in ASHRAE 29-2009 and ASHRAE 29-2015. DOE also seeks information on how manufacturers and third-party labs are currently testing and measuring the calorimeter constant for the ice hardness adjustment factor and if there are any best practices to ensure the calorimeter constant remains in the required range. Alternatively, DOE requests feedback on whether a wider range of allowable calorimeter constant would allow for less burden on manufacturers while still accurately measuring energy use during a representative average use cycle.

DOE is interested in learning if additional direction on how certain equipment should be configured for and operated during testing, including installation of temporary baffles and purge settings, may improve the accuracy of the test procedure and reduce testing burden.

After publication of the January 2012 TP final rule, DOE received an inquiry as to whether the DOE test procedure allows for temporary air baffles to be installed between the ACIM condenser air discharge and condenser air inlet. DOE issued final test procedure guidance on September 24, 2013 (“2013 baffle guidance”), regarding the use of temporary baffles during testing. 4 As described in the 2013 baffle guidance, a baffle is a partition, usually made of a flat material such as cardboard, plastic, or sheet metal, that reduces or prevents recirculation of warm air from an ice maker's air outlet to its air inlet. Temporary baffles refer to those installed only temporarily during testing and are not part of the ACIM model as distributed in commerce or installed in the field. During testing, the use of temporary baffles can block recirculation of warm condenser discharge air to the cooling air inlet. The purpose of installing a temporary baffle could be, for example, to limit potential temperature fluctuations at the condenser air inlet, where the ambient temperature is measured and maintained within the required conditions. However, such a baffle could also reduce the average temperature of the air entering the inlet, thereby resulting in lower measured energy use compared to testing without a baffle. Therefore, installing a temporary baffle for testing may result in a measured energy use that is not representative of the energy use of the unit as operated by the end user. DOE also determined that installing such temporary baffles is inconsistent with the ACIM test procedure, which states that the unit must be “set up for testing per the manufacturer's written instruction provided with the unit” and that “no adjustments of any kind shall be made to the test unit prior to or during the test that would affect the ice capacity, energy usage, or water usage of the test sample.”  5 Further, “heat exchangers and other accessories shall be used only if they are part of standard equipment furnished with the model tested.”  6 Therefore, DOE's final guidance states that the use of temporary baffles to prevent recirculation of air between the air outlet and inlet of the ice maker during testing is not consistent with the DOE test procedure for automatic commercial ice makers, unless the baffle is (a) a part of the ice maker or (b) shipped with the ice maker to be installed according to the manufacturer's installation instructions. The guidance also states that temperature measuring devices may be shielded so that the indicated temperature will not be affected by the intermittent passing of warm discharge air at the measurement location. However, the shields must not block recirculation of this air into the condenser or ice maker inlet.

Issue 4: DOE is considering amending the ACIM test procedure to explicitly state that temporary baffles may not be used for testing, unless the baffle is (a) part of the ice maker or (b) shipped with the ice maker to be installed according to manufacturers' installation instructions. DOE requests comment on whether manufacturers and test laboratories currently test consistent with the 2013 baffle guidance and whether any further instructions are needed.

Purge water refers to water that is introduced into the ice maker during an ice-making cycle, in addition to the water that becomes ice, in order to flush dissolved solids out of the ice maker and prevent scale buildup on the ice maker's wetted surfaces. Ice makers generally allow for setting the purge water controls to provide different amounts of purge water or different frequencies of purge cycles. Different amounts of purge water may be appropriate for different locations based on the level of hardness or contaminants in the ACIM water supply. Most ice makers have manually set purge settings that provide a fixed amount of purge water, but some ice makers include an automatic purge water control setting that automatically adjusts the purge water quantity based on the supply water hardness. Neither AHRI 810-2016 nor ASHRAE 29-2015 indicate how to set a purge water control that provides multiple purge water settings.

Since purge water is cooled by the ice maker, it contributes to energy use during a representative average use cycle. To ensure accurate, representative test results for ice makers with automatic purge water controls, on September 25, 2013, DOE issued final guidance stating that ice makers with automatic purge water control should be tested using a fixed purge water setting  7 that is described in the automatic commercial ice maker's written instructions shipped with the unit as being appropriate for water of normal, typical, or average hardness.

DOE also recognizes that some ice makers, both batch and continuous type models, may introduce additional purges outside of regular cycling (for batch ice makers) or continuous operation (for continuous ice makers). This may occasionally increase the purge water quantity in a way that may not be captured by the current ACIM test procedure. For example, batch ice makers might initiate an extra flush or purge cycle every 12 hours, and continuous ice makers might pause the ice making operation periodically to accomplish the additional purge. Testing according to the current test procedure may not include such a purge cycle, and thus the resulting tested energy use may not accurately represent an average use cycle. Neither ASHRAE 29-2015, nor the prior version, AHSRAE 29-2009, which is incorporated by reference in the DOE test procedure, addresses the possibility of operational events that do not occur continuously or with every cycle. ASHRAE 29-2015 states only in section 7.1.1 that the ice maker must be stable for capacity test data to be valid, and defining this stability as two consecutive cycles (for batch ice makers) or two consecutive 15-minute periods (for continuous ice makers) with a harvest weight difference of no more than 2 percent.

Issue 5: DOE requests comment on whether purge settings affect measured energy use during a representative average use cycle. If purge settings do affect measured energy use, DOE also requests comment on (1) what purge settings should be considered for testing for ACIM equipment with multiple or automatic purge settings, and (2) whether any ACIM models exist that have automatic purge settings but do not have a fixed purge setting appropriate for “normal” water hardness and, if such a unit exists, how it should be tested.

Issue 6: DOE requests comment on the presence and frequency of any “additional” or “increased-water” purge cycles and their impact on energy and potable water use and/or condenser water use. DOE also requests comment on how the test procedure could be modified, if necessary, to more accurately measure this energy use during a representative average use cycle.

Remote condensing ice maker means a type of automatic commercial ice maker in which the ice-making mechanism and condenser or condensing unit are in separate sections. 10 CFR 431.132. This includes both “Remote Condensing (but not remote compressor),” and “Remote Condensing and Remote Compressor” ice makers. The DOE test procedure and industry test procedures, both those currently incorporated by reference and the most recently updated standards, require setting up the ice maker in accordance with the manufacturer's recommendations. AHRI 810 includes the requirement to install remote condensing ice makers with at least 25 feet of interconnection tubing on each line. Otherwise, there are no specific instructions for remote condensing ice makers. Certain remote ice makers are typically paired with pre-charged refrigerant lines for installation with the condenser or condensing unit. However, if a pre-charged line set is not recommended by the manufacturer, additional line set specifications and charging instructions may be needed for testing.

Additionally, it is possible that manufacturers may not always recommend a specific condensing unit to be paired with each remote condensing ice maker model. Based on a review of the market, DOE is aware of continuous remote condensing ice makers that are meant to be connected to a compressor rack instead of a single paired condensing unit. For other remote condensing equipment with a similar setup, for example, commercial refrigeration equipment, the test procedure relies on a refrigerant enthalpy calculation and assumed compressor efficiency based on evaporator temperature to estimate the energy consumption of a compressor rack refrigeration system. A similar approach may be appropriate for remote condensing ice makers intended to be installed without a dedicated condensing unit. Such a configuration would also require additional test instructions regarding appropriate refrigerants and representative refrigerant conditions.

Issue 7: DOE requests comment on whether the current test procedure could be improved to more accurately measure energy use during a representative average use cycle for remote condensing ice makers with dedicated condensing units. For example, DOE requests feedback on whether default refrigerant charging and line set specifications would be necessary absent manufacturer recommendations. DOE also seeks information on whether any additional test instructions would be needed for remote condensing ice makers.

Issue 8: DOE also requests comment on the appropriate test approach for those ice makers intended to be installed without a dedicated condensing unit. DOE seeks feedback on what types of these units are available on the market ( i.e., batch vs. continuous), whether an enthalpy test approach similar to that used for commercial refrigeration equipment would be appropriate for testing these ice makers, and if so, any additional instructions that would be needed for such testing.

The ACIM test procedure specifies standard test conditions to ensure that results reflect energy use during a representative average use cycle and are not unduly burdensome for manufacturers to perform. DOE seeks comment on whether modifications to these standard test conditions could improve the accuracy of the test procedure or reduce testing burden, as discussed further in the following sections.

Variation in the moisture content of ambient air may affect the energy consumption of ice makers. However, AHRI 810 and ASHRAE 29 do not specify a standard condition or tolerance for relative humidity or wet bulb temperature. In contrast, test procedures for most other refrigeration equipment specify these values. Table II.2 summarizes relative humidity and wet bulb temperature specifications for commercial refrigeration equipment and refrigerated beverage vending machines. DOE is interested in understanding: (1) Whether specifying a standard condition or tolerance for relative humidity or wet bulb temperature may improve the accuracy of the test procedure, and (2) how adding this test condition may affect testing burden.

Issue 9: DOE requests comment on (1) how moisture content of ambient air impacts ACIM performance, and (2) the burden of specifying a humidity range during testing.

Currently, water hardness is not a specified test condition under AHRI 810 and ASHRAE 29. Based on testing observed and reviewed by DOE and industry feedback, hard water can affect energy consumption in the field due to variation in purge settings and scale build up on the heat exchanger surfaces over time. However, hard water may also impact the tested performance, as harder water has a greater concentration of total dissolved solids and chemical ions, which decreases the freezing temperature of water and could potentially increase energy use. DOE is interested in whether specifying water hardness (the quantity of dissolved solids in the water) as a testing condition is necessary to ensure the test procedure is reasonably designed to produce test results that measure energy efficiency during a representative average use cycle or period of use.

In the January 2012 ACIM TP final rule, DOE declined to set requirements for water hardness as DOE did not have sufficient information to allow proper consideration of such a requirement. Specifically, DOE did not have information regarding the impact of variation in water hardness on as-tested performance of ACIM equipment and, as such, did not believe the additional burden associated with establishing a standardized water hardness requirement could be justified at that time. 77 FR 1591, 1605-1606 (Jan. 11, 2012). Through testing conducted since the January 2012 ACIM TP final rule, DOE has found that water hardness may impact the tested results for an ACIM basic model and is interested in seeking feedback from interested parties on how it should be considered, if at all, in any potential test procedure revisions. Recognizing that including specifications for water hardness in the test procedure could add burden, DOE is also interested in determining the relative benefits of determining an appropriate target value or range for testing as compared to the test burden it might add.

Issue 10: DOE requests information regarding (1) the impact of total dissolved solids and ion concentration on measured energy and water use during the limited operation associated with testing during a representative average use cycle ( i.e., before significant scaling of solids onto ice maker surfaces has occurred), (2) any experience manufacturers have testing ACIM equipment with prepared solutions of known water hardness, and (3) the effect a water hardness test condition would have on testing burden.

The current ACIM test procedure incorporates by reference AHRI 810-2007, which specifies an ambient temperature of 90 °F and a supply water temperature of 70 °F. AHRI 810-2016 provides the same specifications. However, many ice makers may be installed in conditioned environments such as offices, schools, hospitals, hotels, and convenience stores (see 80 FR 4646, 4700; Jan. 28, 2015), which may have ambient air temperatures closer to 70 °F and supply water temperatures closer to 50 °F.

Issue 11: DOE requests comment on the whether the ambient air temperature and water supply temperature specified in AHRI 810-2016, and in the current DOE test procedures, are appropriately representative of those temperatures during an average use cycle or whether different temperature specifications should be considered. In particular, DOE requests data and information describing the ambient air temperature and supply water temperature of different applications at which ACIM equipment are operated.

DOE is also specifically reviewing the requirements for ambient temperature gradient, which may have an impact on tested energy use. The current ACIM test procedure incorporates by reference section 5.1.1 of ASHRAE 29-2009, which stipulates that, with the ice maker at rest, the vertical ambient temperature gradient in any foot of vertical distance from 2 inches above the floor or supporting platform to a height of 7 ft above the floor, or to a height of 1 ft above the top of the ice maker cabinet, whichever is greater, shall not exceed 0.5 °F/ft. This requirement is identical in section 5.1.1 of ASHRAE 29-2015, which is incorporated by reference in AHRI 810-2016. DOE notes that this language is based on test room requirements for residential refrigerators, as specified in section 7.2 of ANSI-AHAM Standard HRF-1-1979, “Household Refrigerators, Combination Refrigerator-Freezers, and Household Freezers” (“ANSI/AHAM HRF-1-1979”), the version of the AHAM standard that was incorporated by reference in the DOE test procedure for residential refrigerators in a final rule published August 10, 1982. 47 FR 34517. DOE notes further that DOE modified the requirements associated with temperature gradient for residential refrigerators, in a final rule published April 21, 2014, to remove the reference to a 7 ft height requirement and only require the gradient be maintained to a height 1 ft higher than the top of the unit. 79 FR 22320. DOE is interested in understanding the applicability of the air temperature gradient requirements to ice makers, and whether a similar modification, or any other modifications, would improve the accuracy of the test procedure or reduce testing burden.

Issue 12: DOE requests comment on how manufacturers are demonstrating compliance with the temperature gradient requirements of section 5.1.1 of ASHRAE 29-2015. DOE seeks feedback on whether updates consistent with the temperature gradient requirements for consumer refrigeration products would be appropriate for the ACIM test procedure, and whether such updates would reduce test variability and testing burden.

ASHRAE 29 states that the average ambient temperature shall not vary by more than 2 °F from the specified temperature during the first five minutes of each freeze cycle, and not vary by more than 1 °F thereafter. However, the current ACIM test procedure, which is based on AHRI 810 and ASHRAE 29, does not indicate whether ambient temperature measuring instruments should be weighted with a thermal mass. The use of a weighted temperature measurement instrument reduces the fluctuations in temperature measurement, making it easier to meet the stability criteria relative to an unweighted temperature measurement instrument.

Issue 13: DOE requests comment on whether manufacturers typically use weighted or unweighted temperature measurement instruments to measure ambient temperatures during ice maker testing. In addition, DOE requests comment on reduction in fluctuation when using weighted temperature measurement instruments compared to unweighted temperature measurement instruments. DOE also seeks comment and data on benefit and burdens of using unweighted temperature measurement instruments compared to weighted temperature measurement instruments.

As discussed in section I.A, EPCA requires that test procedures be reasonably designed to produce test results that reflect the energy efficiency, energy use, and estimated operating costs (as applicable) of a type of industrial equipment during a typical cycle of use and not be unduly burdensome to conduct. (42 U.S.C. 6314(a)(2)) The accuracy and repeatability of the ACIM test procedure are important to consider to ensure that test results are representative of typical energy consumption in the field. DOE notes that the current ACIM test procedure incorporates by reference AHRI 810-2007 and ASHRAE 29-2009 to specify the aforementioned measurement methods, tolerances, and accuracies. These specifications have not changed in the most recent versions of these standards, namely AHRI 810-2016 and ASHRAE 29-2015. DOE is interested in whether it should consider modifications to existing test condition tolerances, instrumentation accuracies, and temperature measurement methods that would improve accuracy and precision in test results.

For example, specifying tighter tolerances and/or more accurate measurement equipment can lead to increased accuracy in measuring energy use. However, doing so may also increase the burden associated with testing due to the added cost of higher-precision instruments or increased testing time to achieve tighter tolerances. DOE is therefore interested in getting feedback from interested parties on the technical feasibility or burden associated with reducing the uncertainty in those variables.

Issue 14: DOE requests comment on the potential improvement in testing accuracy and increase in testing burden and costs associated with tightening the tolerances and increasing the instrumentation accuracies specified by the current ACIM test procedure.

The industry test methods incorporated by reference by the DOE ACIM test procedure, ASHRAE 29 and AHRI 810, added measurement and reporting requirements for potable water use. This measurement is not required by the current DOE test procedure, but is required by other programs, such as ENERGY STAR  8 and the AHRI certification program. 9 Since DOE establishes test procedures for the ENERGY STAR program, DOE is interested in seeking feedback from interested parties about whether any updates to the test method for potable water use are needed at this time, including any that may reduce the burden of the current method.

In the January 2012 ACIM TP final rule, DOE declined to establish a test procedure or metric for non-condenser potable water use and noted that no statutory authority to do so exists under EPCA. 77 FR 1591, 1604-1605 (Jan. 11, 2012). Specifically, EPCA prescribes standards for condenser water use in cube type ice makers at 42 U.S.C. 6313(d)(1) and explicitly states that prescribed standard levels for condenser water use “does not include potable water used to make ice.” EPCA allows, but does not require, the Secretary to issue analogous standards for other types of automatic commercial ice makers under 42 U.S.C. 6313(d)(2). 77 FR 1591, 1605 (Jan. 11, 2012). In general, DOE assumes ice makers that use less potable water would be expected to use less energy, because they have to cool less water. In the January 2012 ACIM TP final rule, DOE stated that, while there is generally a correlation between energy use and potable water use, at a certain point of reduced potable water use, the relationship between potable water use and energy consumption reverses due to scaling. Id.

DOE reviewed the relationship between potable water use and both harvest rate and daily energy consumption by analyzing reported ACIM data from the AHRI directory and the ENERGY STAR product database. 10 11 DOE observed that all manufacturers of continuous ice-makers report a consistent amount of potable water use per 100 pounds of ice—between 11.9 and 12.0 gallons—because all of the water is converted to produce ice. In contrast, potable water use varies for batch type ice makers, because a portion of the potable water is drained from the sump at the end of each ice-making cycle; this portion is different for different ice maker models. The relationship between potable water use and daily energy consumption of the AHRI and ENERGY STAR data is not identifiable when considering the entire dataset. Thus, DOE is interested in seeking feedback on any potential relationship between potable water use and daily energy consumption and whether, and how, this relationship impacts consumer utility of ACIMs, for example, by affecting the quality of ice produced.

Issue 15: DOE requests comment and information on the relationship between potable water use and energy use, including data quantifying the relationship. Additionally, DOE requests comment and information on any potential impact that this relationship has on possible consumer utility.

The existing ACIM test procedure considers only active mode energy use when an ice maker is actively producing ice and reflects that consumption using a metric of energy use per 100 pounds of ice. The existing ACIM test procedure does not address standby energy use associated with continuously powered sensors and controls or ice storage. However, when not actively making ice, an ice maker continues to consume energy to power sensors and controls. In this way, standby energy use from control devices impact the daily energy consumption of ACIM equipment.

Issue 16: DOE requests data and information on the magnitude of energy use associated with standby energy use, as well as the relationship of such values to daily energy consumption of ACIM equipment.

In addition to the issues identified earlier in this document, DOE welcomes comment on any other aspect of the existing test procedures for ACIM that could be improved to more accurately reflect energy use during a representative average use cycle or reduce testing burden. DOE particularly seeks information that would improve the repeatability, reproducibility, and consumer representativeness of the test procedures. DOE also requests information that would help DOE create a procedure that would limit manufacturer test burden through streamlining or simplifying testing requirements. Comments regarding the repeatability and reproducibility are also welcome.

DOE also requests feedback on any potential amendments to the existing test procedure(s) that could be considered to address impacts on manufacturers, including small businesses. Regarding the Federal test method, DOE seeks comment on the degree to which the DOE test procedure should consider and be harmonized with the most recent relevant industry standards for ACIM and whether there are any changes to the Federal test method that would provide additional benefits to the public. DOE also requests comment on the benefits and burdens of adopting any industry/voluntary consensus-based or other appropriate test procedure, without modification. DOE notes that AHRI 810, which references ASHRAE 29, does not include test specifications that may impact energy use ( e.g., relative humidity) and includes specifications that may not be representative of field use ( e.g., ambient and inlet water temperature).

Additionally, DOE requests comment on whether the existing test procedure limits a manufacturer's ability to provide additional features to consumers on ACIM. DOE particularly seeks information on how the test procedure could be amended to reduce the cost of new or additional features and make it more likely that such features are included on ACIM.

DOE invites all interested parties to submit in writing by April 18, 2019, comments and information on matters addressed in this document and on other matters relevant to DOE's consideration of amended test procedures for ACIM. These comments and information will aid in the development of a test procedure NOPR for ACIM if DOE determines that amended test procedures may be appropriate for this equipment.

Submitting comments via http://www.regulations.gov. The http://www.regulations.gov web page will require you to provide your name and contact information. Your contact information will be viewable to DOE Building Technologies staff only. Your contact information will not be publicly viewable except for your first and last names, organization name (if any), and submitter representative name (if any). If your comment is not processed properly because of technical difficulties, DOE will use this information to contact you. If DOE cannot read your comment due to technical difficulties and cannot contact you for clarification, DOE may not be able to consider your comment.

However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.

Do not submit to http://www.regulations.gov information for which disclosure is restricted by statute, such as trade secrets and commercial or financial information (hereinafter referred to as Confidential Business Information (CBI)). Comments submitted through http://www.regulations.gov cannot be claimed as CBI. Comments received through the website will waive any CBI claims for the information submitted. For information on submitting CBI, see the Confidential Business Information section.

DOE processes submissions made through http://www.regulations.gov before posting. Normally, comments will be posted within a few days of being submitted. However, if large volumes of comments are being processed simultaneously, your comment may not be viewable for up to several weeks. Please keep the comment tracking number that http://www.regulations.gov provides after you have successfully uploaded your comment.

Submitting comments via email, hand delivery, or mail. Comments and documents submitted via email, hand delivery, or mail also will be posted to http://www.regulations.gov. If you do not want your personal contact information to be publicly viewable, do not include it in your comment or any accompanying documents. Instead, provide your contact information on a cover letter. Include your first and last names, email address, telephone number, and optional mailing address. The cover letter will not be publicly viewable as long as it does not include any comments.

Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.

Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.

Campaign form letters. Please submit campaign form letters by the originating organization in batches of between 50 to 500 form letters per PDF or as one form letter with a list of supporters' names compiled into one or more PDFs. This reduces comment processing and posting time.

Confidential Business Information. According to 10 CFR 1004.11, any person submitting information that he or she believes to be confidential and exempt by law from public disclosure should submit via email, postal mail, or hand delivery two well-marked copies: One copy of the document marked confidential including all the information believed to be confidential, and one copy of the document marked “non-confidential” with the information believed to be confidential deleted. Submit these documents via email or on a CD, if feasible. DOE will make its own determination about the confidential status of the information and treat it according to its determination.

Factors of interest to DOE when evaluating requests to treat submitted information as confidential include (1) a description of the items, (2) whether and why such items are customarily treated as confidential within the industry, (3) whether the information is generally known by or available from other sources, (4) whether the information has previously been made available to others without obligation concerning its confidentiality, (5) an explanation of the competitive injury to the submitting person which would result from public disclosure, (6) when such information might lose its confidential character due to the passage of time, and (7) why disclosure of the information would be contrary to the public interest.

It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).

DOE considers public participation to be a very important part of the process for developing test procedures and energy conservation standards. DOE actively encourages the participation and interaction of the public during the comment period in each stage of this process. Interactions with and between members of the public provide a balanced discussion of the issues and assist DOE in the process. Anyone who wishes to be added to the DOE mailing list to receive future notices and information about this process should contact Appliance and Equipment Standards Program staff at (202) 287-1445 or by email: ApplianceStandardsQuestions@ee.doe.gov.

The Mitigation Strategies to Protect Food Against Intentional Adulteration rule (IA rule, 21 CFR part 121, published in the Federal Register of May 27, 2016, 81 FR 34165) requires domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to address hazards that may be introduced with the intention to cause wide scale public health harm. These food facilities are required to conduct a vulnerability assessment to identify significant vulnerabilities and actionable process steps and implement mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. The rule is part of the Agency's ongoing efforts to implement the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353).

In the Federal Register of June 20, 2018 (83 FR 28651), we announced the first installment of the draft guidance on complying with the IA rule, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Draft Guidance for Industry.” More recently, in the Federal Register of March 6, 2019 (84 FR 8103), we announced the availability of the second installment of the draft guidance. Both installments provide information on and recommendations for compliance with important requirements of the IA rule. The comment period on both installments of the draft guidance is open until July 5, 2019, for comments to be considered before work in begun on a final guidance. 1

FDA is announcing a public meeting entitled, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Draft Guidance for Industry.” The meeting will be held during the comment period on the draft guidance.

While oral presentations from specific individuals and organizations will be necessarily limited due to time constraints during the public meetings, stakeholders may submit electronic or written comments discussing any issues of concern to the administrative record (the docket) for the draft guidance (Docket No. FDA-2018-D-1398).

The purpose of the public meeting is to provide information and facilitate comments so that stakeholders can better evaluate and provide input on the draft guidance. We invite interested parties to provide information and offer comments related to the IA rule draft guidance. During the public meeting, we will present information on the draft guidance, with emphasis on chapters related to rule requirements for vulnerability assessments; mitigation strategies; food defense monitoring; and education, training, or experience. There will be an opportunity for questions, as well as an opportunity for open public comment.

Registration: To register for the public meeting, please visit the following website by April 10, 2019: https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone.

Registration is free and based on space availability. Persons interested in attending this public meeting must register by April 10, 2019, 11:59 p.m. Eastern Time. Early registration is recommended because seating is limited; therefore, FDA may limit the number of participants from each organization. Registrants will receive confirmation when they have been accepted. If time and space permit, onsite registration on the day of the public meeting will be provided beginning at 8 a.m. We will let registrants know if registration closes before the day of the public meeting.

For questions about registering for the meeting or to register by phone, please contact Melissa Schroeder (see FOR FURTHER INFORMATION CONTACT ).

If you need special accommodations due to a disability, please contact Juanita Yates, (see FOR FURTHER INFORMATION CONTACT ) no later than March 28, 2019.

Requests for Oral Presentations: During online or telephone registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address. We will do our best to accommodate requests to make public comments. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by April 3, 2019. All requests to make oral presentations must be received by March 28, 2019. No commercial or promotional material will be permitted to be presented or distributed at the public meeting.

Streaming Webcast of the Public Meeting: This public meeting will also be webcast. https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register , but websites are subject to change over time.

Transcripts: Please be advised that as soon as a transcript of the public meeting is available, it will be accessible at https://www.regulations.gov. It may also be viewed at the Dockets Management Staff (see ADDRESSES ). A link to the transcript will also be available on the internet at https://www.fda.gov/Food/NewsEvents/WorkshopsMeetingsConferences/default.htm.

Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 348(b)(5)), notice was given in the Federal Register of April 18, 2017 (82 FR 18268), that a food additive petition (FAP 2299) has been filed by the Canadian Oilseed Processors Association, 404-167 Lombard Ave., Winnipeg MB R3B 0T6, Canada. The petition proposes to amend Title 21 of the Code of Federal Regulations (CFR) in part 573 Food Additives Permitted in Feed and Drinking Water of Animals (21 CFR part 573) to provide for the safe use of spent bleaching clay as a flow agent in canola meal for all livestock and poultry species. Additionally, the submission proposes that the existing regulations be amended to provide for the safe use of silicon dioxide (21 CFR 573.940) and diatomaceous earth (21 CFR 573.340) for use as components of spent bleaching clay.

This petition included a request for categorical exclusion, but after review we determined the proposed action on spent bleaching clay does not meet the criteria for a categorical exclusion under 21 CFR 25.32(r). The petitioner has prepared and submitted an EA.

We are reviewing the potential environmental impact of this petition. To encourage public participation consistent with regulations issued under the National Environmental Policy Act (40 CFR 1501.4(b)), we are placing the EA submitted with the petition that is the subject of this notice on public display at the Dockets Management Staff (see DATES and ADDRESSES ) for public review and comment.

We will also place on public display, at the Dockets Management Staff and at https://www.regulations.gov, any amendments to, or comments on, the petitioner's EA without further announcement in the Federal Register . If, based on our review, we find that an environmental impact statement is not required, and this petition results in a regulation, we will publish the notice of availability of our finding of no significant impact and the evidence supporting that finding with the regulation in the Federal Register in accordance with 21 CFR 25.51(b).

On November 26, 2018, the Alcohol and Tobacco Tax and Trade Bureau (TTB) published in the Federal Register (83 FR 60562) a notice of proposed rulemaking, Notice No. 176, Modernization of the Labeling and Advertising Regulations for Wine, Distilled Spirits, and Malt Beverages. In that document, TTB proposes to reorganize and recodify its regulations governing the labeling and advertising of wine, distilled spirits, and malt beverages in order to simplify and clarify regulatory standards, incorporate guidance documents and current policy into the regulations, and reduce the regulatory burden on industry members where possible. As originally published, the public comment period for Notice No. 176 was to close on March 26, 2019.

In response to Notice No. 176, as of February 26, 2019, TTB has received eight requests from industry trade associations to extend the comment period for that document. Comments from the Wine Institute (comment 24), the American Distilled Spirits Association (comment 27), the National Association of Manufacturers (comment 56), the Brewers Association (comment 57), the Distilled Spirits Council (comment 58), the Napa Valley Vintners (comment 64), and Wine America (comment 75) request 90-day extensions of the comment period. The comment from the United States Association of Cider Makers (USACM; comment 47) requests a 60-day extension of the comment period.

As reasons to extend the comment period, those requests cite such things as the proposed rule's complex and technical nature, its length, and its publication during the holiday season. These requests are posted within Docket No. TTB-2018-0007 on the Regulations.gov website at https://www.regulations.gov.

In response to these requests, TTB is extending the comment period for Notice No. 176 for an additional 90 days. TTB will now accept public comments on Notice No. 176 through June 26, 2019.

On June 21, 2018, the City of Philadelphia, Air Management Services (AMS) through the Pennsylvania Department of Environmental Protection (PADEP) submitted a formal revision to the Pennsylvania SIP. The SIP revision consists of an amendment to 40 CFR 52.2020(c)(3), the Philadelphia County portion of the SIP  1 , in order to implement provisions for lower sulfur levels in commercial fuel oil in Philadelphia County.

Sulfur dioxide (SO 2 ) emissions contribute to the formation of fine particulate matter (PM 2.5 ) and sulfates in the atmosphere, and subsequently to the formation of regional haze. Regional haze is visibility impairing pollution that scatters and absorbs light. The pollutants that cause visibility impairment come from sources and activities that emit fine particles and their precursors, SO 2 , PM 2.5 , nitrogen oxides (NO X ), and volatile organic compounds (VOCs).

The June 21, 2018 SIP revision consists of amendments to the Philadelphia County portion of the Pennsylvania SIP regarding provisions for lower sulfur levels in fuel oil in Philadelphia that are more stringent than the state-wide SIP-approved provisions. 2 Since 1972, the Pennsylvania SIP has contained provisions limiting the amount of sulfur allowable in fuel oils in Philadelphia County. In recent years, amendments were made to Title 3 of the Philadelphia Code, the Air Management Code (AMC) and to Air Management Regulation (AMR) III, to lower the maximum allowable level of sulfur in number 2 and lighter fuel oils, to impose more stringent levels on number 4 commercial fuel oils, and to add exemption provisions relating to commercial fuel oil. 3

On March 15, 2018, the Maryland Department of Environment (MDE) submitted a revision to its SIP to certify that the existing Maryland vehicle emission inspection program implemented in the Baltimore ozone nonattainment area satisfies the CAA section 182(b)(4) requirements for a vehicle inspection program applicable to the Baltimore 2008 moderate ozone nonattainment area.

On March 27, 2008, EPA revised the primary and secondary 8-hour ozone NAAQS to 0.075 parts per million (ppm) to provide increased protection of public health and welfare (73 FR 16436). The 2008 8-hour ozone NAAQS replaced the previous 1997 8-hour ozone NAAQS of 0.080 ppm. Those standards are met when the 3-year average of the annual fourth highest daily maximum 8-hour average ozone concentration of all ambient air monitors is less than or equal to 0.075 ppm.

Promulgation of a revised NAAQS triggers a requirement for EPA to designate all areas of the nation as nonattainment, attainment, or unclassifiable for the NAAQS. For the ozone NAAQS, this also involves classifying any nonattainment areas at the time of designation—per requirements set forth at CAA sections 107(d)(1) and 181(a)(1). Ozone nonattainment areas are classified based on the severity of their ozone levels (as determined based on the area's “design value,” which represents the most recent three years of monitored air quality in an area). The CAA-established classifications for ozone nonattainment areas are: Marginal, Moderate, Serious, Severe, and Extreme. 1 Nonattainment areas with a “lower” classification have ozone levels that are closer to the standard than areas with a “higher” classification. 2 As such, ozone nonattainment areas with lower classification levels have fewer and less stringent mandatory air quality planning and control requirements than those having higher classifications. For each higher ozone nonattainment classification, a state needs to comply with all requirements applicable to the next classification, plus additional emissions controls and more expansive nonattainment new source review offset requirements. In addition to nonattainment requirements, the CAA sets out additional specific requirements for states in an established ozone transport region (OTR), regardless of their ozone attainment designation. 3 These separate OTR requirements mandate that states in the OTR enact enhanced vehicle I/M programs, based on population of metropolitan areas of the state—but not nonattainment designation. 4

Under the 2008 ozone NAAQS requirements, Maryland is required to implement a basic I/M program for light-duty motor vehicles in the Baltimore moderate ozone nonattainment area (consisting of Anne Arundel, Baltimore, Carroll, Harford, and Howard Counties and the City of Baltimore). However, due to higher ozone nonattainment classifications (under prior ozone NAAQS) and Maryland's inclusion in the OTR, Maryland currently operates an enhanced I/M program (known in Maryland as the Vehicle Emissions Inspection program, or VEIP) in all I/M-subject regions of the state—including the Baltimore ozone nonattainment area. Maryland's enhanced I/M VEIP program tests gasoline-fueled motor vehicles up to 26,000 pounds gross vehicle weight rating (GVWR), with onboard diagnostic (OBD) testing required for model year 1996 and newer passenger vehicles and light-duty trucks and model year 2008 and newer heavy-duty vehicles up to 14,000 pounds GVWR. VEIP also includes a tailpipe idle and a gas cap test, as well as a catalyst check, for model year 1977 and newer heavy-duty vehicles between 8,500 and 26,000 pounds (that are not otherwise subject to OBD testing).

EPA requirements for I/M programs are set forth in EPA's Inspection and Maintenance Program Requirements Rule (or I/M rule), codified in the Code of Federal Regulations, at 40 CFR part 51, subpart S. Requirements for minimum performance of enhanced I/M programs are established in 40 CFR 51.351 and those of a basic I/M programs are set forth in 40 CFR 51.352. EPA's I/M rule delineates more stringent transient tailpipe testing methods and tighter testing limits (or equivalent) and on-road testing for enhanced I/M programs, as well as vehicle evaporative system functional testing (or equivalent).

Maryland's enhanced I/M program under the 1990 CAA was first approved by EPA into the Maryland SIP via a final conditional approval published in the July 31, 1997 Federal Register (62 FR 40938). Upon remedy of deficiencies underlying that conditional approval action, EPA converted the conditional approval to a final approval via a final rule published in the October 29, 1999 Federal Register (64 FR 58340). Maryland has since made several modifications to its enhanced I/M program to accommodate CAA requirements and changing state interests, to update testing methods to reflect changes in vehicle technology—such as implementation of OBD testing. As part of the OTR, Maryland is required to implement an enhanced I/M program in specific areas, as required by CAA section 184(b)(1).

Maryland submitted a SIP revision on March 15, 2018 to attest and to certify that its existing enhanced I/M program meets requirements established by EPA's I/M rule for a basic I/M program. Maryland also demonstrates, through use of EPA's Motor Vehicle Emission Simulator (MOVES), that the VEIP enhanced I/M program will outperform a basic I/M program in reducing ozone precursor emissions ( i.e., nitrogen oxides (NO X ) and volatile organic compounds (VOCs)). Maryland used MOVES version 2014a to model both the current Baltimore area VEIP enhanced I/M program and the EPA basic performance standard  5 that applies to areas newly designated nonattainment under the 2008 ozone NAAQS. The MDE evaluated the benefits of the existing enhanced VEIP program in Baltimore against a hypothetical basic program for a 2012 evaluation date (which corresponds to the date of classification of Baltimore as a Serious area for the 2008 ozone NAAQS, under Subpart 2 of Part D of the CAA) and again with a 2018 evaluation date (which corresponds to the Baltimore 2008 ozone NAAQS attainment deadline, six years after EPA classification under the 2008 ozone NAAQS). The results of this MOVES model comparison between the existing enhanced I/M VEIP program and EPA's basic performance standard are summarized in Table 1. Maryland found that for both the 2012 and 2018 evaluation years, modelled emissions were shown to be higher than the existing VEIP I/M program for both NO X and VOC, as well as combined NO X and VOC, for the Baltimore nonattainment area under EPA's basic performance standard.

I. Background

On May 23, 2018, the Department of Energy and Environment (DOEE) submitted on behalf of the District of Columbia (District) a formal SIP revision, requesting EPA's approval of its NNSR Certification for the 2008 8-hour ozone NAAQS. This SIP revision is in response to EPA's final 2008 8-hour ozone NAAQS Findings of Failure to Submit for NNSR requirements. See 82 FR 9158 (February 3, 2017). Specifically, the District is certifying that its existing NNSR program, covering the District portion of the Washington, DC-MD-VA Nonattainment Area (Washington Area) for the 2008 8-hour ozone NAAQS, is at least as stringent as the requirements at 40 CFR 51.165, as amended by the final rule titled “Implementation of the 2008 National Ambient Air Quality Standards for Ozone: State Implementation Plan Requirements” (SIP Requirements Rule), for ozone and its precursors. 1 2 See 80 FR 12264 (March 6, 2015).

On March 12, 2008, EPA promulgated a revised 8-hour ozone NAAQS of 0.075 parts per million (ppm). See 73 FR 16436 (March 27, 2008). Under EPA's regulations at 40 CFR 50.15, the 2008 8-hour ozone NAAQS is attained when the three-year average of the annual fourth-highest daily maximum 8-hour average ambient air quality ozone concentration is less than or equal to 0.075 ppm.

Upon promulgation of a new or revised NAAQS, the CAA requires EPA to designate as nonattainment any area that is violating the NAAQS based on the three most recent years of ambient air quality data at the conclusion of the designation process. The Washington Area was classified as marginal nonattainment for the 2008 8-hour ozone NAAQS on May 21, 2012 (effective July 20, 2012) using 2008-2010 ambient air quality data. See 77 FR 30088. On March 6, 2015, EPA issued the final SIP Requirements Rule, which establishes the requirements that state, tribal, and local air quality management agencies must meet as they develop implementation plans for areas where air quality exceeds the 2008 8-hour ozone NAAQS. See 80 FR 12264. Areas that were designated as marginal ozone nonattainment areas were required to attain the 2008 8-hour ozone NAAQS no later than July 20, 2015, based on 2012-2014 monitoring data. See 40 CFR 51.1103. The Washington Area did not attain the 2008 8-hour ozone NAAQS by July 20, 2015; however, the area did meet the CAA section 181(a)(5) criteria, as interpreted in 40 CFR 51.1107, for a one-year attainment date extension. See 81 FR 26697 (May 4, 2016). Therefore, on April 11, 2016, the EPA Administrator signed a final rule extending the Washington Area 8-hour ozone NAAQS attainment date from July 20, 2015 to July 20, 2016. Id. 3

Based on initial nonattainment designations for the 2008 8-hour ozone NAAQS, as well as the March 6, 2015 final SIP Requirements Rule, the District was required to develop a SIP revision addressing certain CAA requirements for the Washington Area, and submit to EPA a NNSR Certification SIP or SIP revision no later than 36 months after the effective date of area designations for the 2008 8-hour ozone NAAQS ( i.e., July 20, 2015). 4 See 80 FR 12264 (March 6, 2015). EPA is proposing to approve the District's May 23, 2018 NNSR Certification SIP revision. EPA's analysis of how this SIP revision addresses the NNSR requirements for the 2008 8-hour ozone NAAQS is provided in Section II below.

Areas designated nonattainment for the ozone NAAQS are subject to the general nonattainment area planning requirements of CAA section 172 and also to the ozone-specific planning requirements of CAA section 182. 5 States in the ozone transport region (OTR), such as the District, are additionally subject to the requirements outlined in CAA section 184.

Ozone nonattainment areas in the lower classification levels have fewer and/or less stringent mandatory air quality planning and control requirements than those in higher classifications. For marginal areas, such as the Washington Area, a state is required to submit a baseline emissions inventory, adopt a SIP requiring emissions statements from stationary sources, and implement a NNSR program for the relevant ozone standard. See CAA section 182(a). For each higher ozone nonattainment classification, a state needs to comply with all lower area classification requirements, plus additional emissions controls and more expansive NNSR offset requirements.

The CAA sets out specific requirements for states in the OTR. 6 Upon promulgation of the 2008 8-hour ozone NAAQS, states in the OTR were required to submit a SIP revision addressing reasonable available control technology (RACT). See 40 CFR 51.1116. This requirement is the only recurring obligation for an OTR state upon revision of a NAAQS, unless that state also contains some portion of a nonattainment area for the revised NAAQS. 7 In that case, the nonattainment requirements described previously also apply to those portions of that state (the District in this case).

In the March 6, 2015 SIP Requirements Rule, EPA detailed the requirements applicable to ozone nonattainment areas, as well as requirements that apply in the OTR, and provided specific deadlines for SIP submittals. See 80 FR 12264.

On February 3, 2017, EPA found that 15 states and the District of Columbia failed to submit SIP revisions in a timely manner to satisfy certain requirements for the 2008 8-hour ozone NAAQS that apply to nonattainment areas and/or states in the OTR. See 82 FR 9158. As explained in that rulemaking action, consistent with the CAA and EPA regulations, these Findings of Failure to Submit established certain deadlines for the imposition of sanctions, if a state does not submit a timely SIP revision addressing the requirements for which the finding is being made, and for the EPA to promulgate a Federal implementation plan (FIP) to address any outstanding SIP requirements.

EPA found, inter alia, that the District failed to submit SIP revisions in a timely manner to satisfy NNSR requirements for the Washington Area. 8 The District submitted its May 23, 2018 SIP revision to address the specific NNSR requirements for the 2008 8-hour ozone NAAQS, located in 40 CFR 51.160-165, as well as its obligations under EPA's February 3, 2017 Findings of Failure to Submit. EPA's analysis of how this SIP revision addresses the NNSR requirements for the 2008 8-hour ozone NAAQS and the Findings of Failure to Submit is provided in Section II of this rulemaking action.

This rulemaking action is specific to the District's NNSR requirements. NNSR is a preconstruction review permit program that applies to new major stationary sources or major modifications at existing sources located in a nonattainment area. 9 The specific NNSR requirements for the 2008 8-hour ozone NAAQS are located in 40 CFR 51.160-165. As set forth in the SIP Requirements Rule, for each nonattainment area, a NNSR plan or plan revision was due no later than 36 months after the July 20, 2012 effective date of area designations for the 2008 8-hour ozone standard ( i.e., July 20, 2015). 10 11

The minimum SIP requirements for NNSR permitting programs for the 2008 8-hour ozone NAAQS are located in 40 CFR 51.165. See 40 CFR 51.1114. These NNSR program requirements include those promulgated in the “Phase 2 Rule” implementing the 1997 8-hour ozone NAAQS (75 FR 71018 (November 29, 2005)) and the SIP Requirements Rule implementing the 2008 8-hour ozone NAAQS. Under the Phase 2 Rule, the SIP for each ozone nonattainment area must contain NNSR provisions that: set major source thresholds for oxides of nitrogen (NO X ) and volatile organic compounds (VOC) pursuant to 40 CFR 51.165(a)(1)(iv)(A)(1)(i)-(iv) and (2); classify physical changes as a major source if the change would constitute a major source by itself pursuant to 40 CFR 51.165(a)(1)(iv)(A)(3); consider any significant net emissions increase of NO X as a significant net emissions increase for ozone pursuant to 40 CFR 51.165(a)(1)(v)(E); consider certain increases of VOC emissions in extreme ozone nonattainment areas as a significant net emissions increase and a major modification for ozone pursuant to 40 CFR 51.165(a)(1)(v)(F); set significant emissions rates for VOC and NO X as ozone precursors pursuant to 40 CFR 51.165(a)(1)(x)(A)-(C) and (E); contain provisions for emissions reductions credits pursuant to 40 CFR 51.165(a)(3)(ii)(C)(1)-(2); provide that the requirements applicable to VOC also apply to NO X pursuant to 40 CFR 51.165(a)(8); and set offset ratios for VOC and NO X pursuant to 40 CFR 51.165(a)(9)(i)-(iii) (renumbered as (a)(9)(ii)-(iv) under the SIP Requirements Rule for the 2008 8-hour ozone NAAQS). Under the SIP Requirements Rule for the 2008 8-hour ozone NAAQS, the SIP for each ozone nonattainment area designated nonattainment for the 2008 8-hour ozone NAAQS and designated nonattainment for the 1997 ozone NAAQS on April 6, 2015, must also contain NNSR provisions that include the anti-backsliding requirements at 40 CFR 51.1105. See 40 CFR 51.165(a)(12).

The District's SIP approved NNSR program, established in Chapters 1 ( Air Quality—General Rules ) and 2 ( Air Quality—General and Nonattainment Area Permits ) in Title 20 of the District of Columbia Municipal Regulations (DCMR), apply to the construction and modification of major stationary sources in nonattainment areas. In its May 23, 2018 SIP revision, the District certifies that the versions of 20 DCMR Chapters 1 and 2 approved in the SIP are at least as stringent as the Federal NNSR requirements for the Washington Area. EPA last approved revisions to the District's major NNSR SIP on March 19, 2015. In that action, EPA approved revisions to the District's SIP which made DOEE's NNSR program consistent with Federal requirements. See 80 FR 14310.

EPA notes that Title 20 DCMR section 199 and the District's SIP is more stringent than 40 CFR 51.165(a)(1)(iv)(A)(1), because the definition of “major stationary source” in 20 DCMR section 199 includes a threshold of 25 tons per year or more of NO X or VOC in any nonattainment area for ozone, which is equivalent to severe ozone nonattainment area classification. As noted previously, the Washington Area is classified as marginal nonattainment for the 2008 8-hour ozone NAAQS. Therefore, by definition, any major stationary source located in the District is subject to a lower emissions threshold for NO X and VOC.

Additionally, in its May 23, 2018 SIP revision, the District noted for various NNSR provisions that, “Should the District attain the NAAQS, because the District has not adopted the Prevention of Significant Deterioration (PSD) portions of New Source Review (NSR), the federal regulations would apply. In this case, because the District is in an Ozone Transport Region (OTR), the federal OTR thresholds would apply.” In order for a nonattainment area to become attainment and for OTR emissions thresholds to apply, the District would have to submit, and EPA would have to approve a redesignation request and maintenance plan for the applicable ozone NAAQS. 12 See CAA Section 184(b). The lack of these provisions in the District's SIP does not impact the requirement to have a fully-approved NNSR program in place, nor does the lack of those requirements impact the approvability of this SIP revision, as the federal requirements would apply or the District could undertake a rulemaking action to update their regulations and subsequently their SIP. For purposes of NNSR, the subject of this rulemaking action, the District's approved NNSR program is at least as stringent as the federal requirements. 13

Neither Title 20 of the DCMR nor the District's approved SIP have the regulatory provisions for an emissions change of VOC in extreme nonattainment areas, specified in 40 CFR 51.165(a)(1)(v)(F) or 40 CFR 51.165(a)(1)(x)(E), because the District's SIP is not required to have this requirement for VOC in extreme nonattainment areas until such a time as the District has an extreme nonattainment area. The District has never been designated as extreme for an ozone NAAQS. 14

Neither 20 DCMR section 204 nor the District's approved SIP contain a regulatory provision pertaining to establishing emissions reductions credits (ERC), as specified in 40 CFR 51.165(a)(3)(ii)(C)(2)(i) and 40 CFR 51.165(a)(3)(ii)(C)(2)(ii). However, even if the District's regulations do not offer this emissions reductions credit option, their approved SIP is still adequate to meet the standard ERC requirements found in 40 CFR 51.165(a)(3)(ii)(C)(1), where emissions reductions must be surplus, permanent, quantifiable, and federally enforceable, for example. The District has the appropriate ERC requirements approved in their regulations and their SIP, which enables them to implement the program appropriately and in accordance with federal requirements. See 20 DCMR Section 204.

Given the D.C. Cir. Court's recent ruling in South Coast Air Quality Mgmt. Dist. v. EPA vacating the anti-backsliding provisions of the SIP Requirements Rule, the District remains required to comply with the anti-backsliding provisions found in 40 CFR 51.165(a)(12). In the District, neither 20 DCMR Chapters 1 and 2 or the District SIP contain anti-backsliding provisions found in 40 CFR 51.165(a)(12), which applied to NNSR requirements for the 1997 ozone NAAQS. However, EPA finds that 20 DCMR and the District's SIP presently include appropriate thresholds for major stationary sources and emissions offset ratios for the worst air quality designations these nonattainment areas have been designated. For example, in 20 DCMR section 199, a source is considered a “major stationary source” if it emits 25 tons per year of NO X or VOC in any nonattainment area for ozone, except for the 10 ton per year or more of NO X and VOC in an extreme nonattainment area for ozone. 15 This emissions threshold is equivalent to an area that was designated as severe nonattainment for the ozone NAAQS and is therefore more stringent. Additionally, emissions offset ratios for sources located in the District are more stringent than the requirements of 40 CFR 51.165(a)(9)(i). 20 DCMR section 204.18 and the approved District SIP require sources in ozone nonattainment areas to offset their NO X and VOC emissions at a ratio of 1.3 to 1 versus the Federal NNSR requirement for a source located in a marginal nonattainment area to offset NO X and VOC at a less stringent ratio of 1.1 to 1. See 40 CFR 51.165(a)(9)(i)(A). Therefore, EPA finds that the District's regulations and approved SIP are more stringent than EPA's NNSR anti-backsliding requirements and their program is adequate to implement NNSR for the 2008 ozone NAAQS.

The versions of 20 DCMR Chapters 1 and 2 that are contained in the current SIP have not changed, with respect to NNSR since the 2015 rulemaking where EPA last approved the District's NNSR provisions. These versions of the rules cover the Washington Area and remain adequate to meet all applicable NNSR requirements for the 2008 8-hour ozone NAAQS found in 40 CFR 51.165, the Phase 2 Rule and the SIP Requirements Rule.

EPA is proposing to approve the District's May 23, 2018 SIP revision addressing the NNSR requirements for the 2008 ozone NAAQS for the Washington Area. EPA has concluded that the District's submission fulfills the 40 CFR 51.1114 revision requirement, meets the requirements of CAA sections 110 and 172 and the minimum SIP requirements of 40 CFR 51.165, as well as its obligations under EPA's February 3, 2017 Findings of Failure to Submit. See 82 FR 9158. EPA is soliciting public comments on the issues discussed in this document. These comments will be considered before taking final action.

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:

• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and

• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

In addition, this proposed rule, approving the District's 2008 8-hour ozone NAAQS Certification SIP revision for NNSR does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.

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 proposed 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 final 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 proposed rule on or after April 18, 2019 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.

EPA is proposing these SNURs under TSCA section 5(a)(2) for chemical substances that were the subject of PMNs and are subject to Orders issued by EPA pursuant to section 5(e) of TSCA. These proposed SNURs would require persons to notify EPA at least 90 days before commencing the manufacture or processing of a chemical substance for any activity proposed as a significant new use. Receipt of such notices would allow EPA to assess risks that may be presented by the intended uses and, if appropriate, to regulate the proposed use before it occurs. Additional rationale and background to these proposed rules are more fully set out in the preamble to EPA's first direct final SNUR published in the Federal Register issue of April 24, 1990 (55 FR 17376). Consult that preamble for further information on the objectives, rationale, and procedures for SNURs and on the basis for significant new use designations, including provisions for developing test data.

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 bulleted 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)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)).

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, and exemptions to reporting requirements. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to 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 significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new 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.

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 addition to these factors enumerated in TSCA section 5(a)(2), the statute authorizes EPA to consider any other relevant factors.

To determine what would constitute a significant new use for the 28 chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances and potential human exposures and environmental releases that may be associated with the conditions of use of the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit.

EPA is proposing significant new use and recordkeeping requirements for 28 chemical substances in 40 CFR part 721, subpart E. In this unit, 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.

• 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. This information may include testing required in a TSCA section 5(e) Order to be conducted by the PMN submitter, as well as testing not required to be conducted but which would also help characterize the potential health and/or environmental effects of the PMN substance. Any recommendation for information identified by EPA 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 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 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 EPA to discuss any potential future testing. See Unit VII. for more information.

• CFR citation assigned in the regulatory text section of the proposed rule. The regulatory text section of each proposed rule specifies the activities that would be 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 proposed rule, may be claimed as CBI. These proposed rules include 28 PMN substances that are subject to Orders issued under TSCA section 5(e)(1)(A). Each Order is based on one or more of the findings in TSCA section 5(a)(3)(B): There is insufficient information to permit a reasoned evaluation; in the absence of sufficient information to permit a reasoned evaluation, the activities associated with the PMN substances may present unreasonable risk to health or the environment; the substance is or will be produced in substantial quantities, and enters or may reasonably be anticipated to enter the environment in substantial quantities or there is or may be significant (substantial) human exposure to the substance. Those Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs would 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 § 721.63 respirator requirements may request to do so under § 721.30. EPA expects that persons whose § 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.

Chemical Names: Fatty acids, C16 and C18-unsaturated, methyl esters, chlorinated (P-15-353) and chlorinated complex esters (generic) (P-15-433).

CAS Numbers: 1642303-17-0 (P-15-353) and not available (P-15-433).

Effective date of TSCA section 5(e) Order: July 25, 2018.

Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the PMN substances will be as lubricant additives. Based on submitted analogue data, EPA has identified concern for irritation. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 4, 1999) and test data on structurally similar substances, the PMN substances are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I) based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substances are or will be produced in substantial quantities and that the substances either enter or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substances.

To protect against these risks, the Order requires:

1. Submission to EPA of certain testing before exceeding the three-year time limit specified in the Order; and

2. Use of the PMN substances only for the confidential uses specified in the Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the fate and environmental effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances 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 that would be designated by this proposed SNUR. The submitter has agreed not to manufacture the PMN substances beyond three years without performing a specific biodegradation study and an ecotoxicity testing scheme for P-15-353 to determine the rate of loss of the parent PMN substances and formation and identification of degradation products, and to assess their toxicity.

CFR citation: 40 CFR 721.11221 (P-15-353) and 40 CFR 721.11222 (P-15-433).

Chemical Name: Sodium branched chain alkyl hydroxyl and branched chain alkenyl sulfonates (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: June 26, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a surfactant. EPA identified concern for lung effects based on surfactant activity if respirable particles are inhaled and concern for irritation based on potential surfactant activity to all exposed tissues. EPA also identified concern for developmental toxicity based on data provided for an analogue. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

1. Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;

2. Refraining from modifying the manufacture, processing or use of the PMN substance in a manner that results in inhalation exposure to vapor, dust, spray, mist or aerosol;

3. Use of the PMN substance only for the confidential use specified in the Order; and

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and Safety Data Sheet (SDS).

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that would be designated by this proposed SNUR. EPA has also determined that the results of specific pulmonary toxicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require this test, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11223.

Chemical Name: Spiro tetrafluoroborate (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: August 6, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as an additive for an electrolyte solution. Based on physical/chemical properties and analysis of test data on the PMN substance, EPA has identified concern for developmental neurotoxicity, effects to the bladder, liver, kidney, thymus, stomach, thyroid, and blood. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(I)(A)(ii)(I) based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

1. Submission to EPA of certain toxicity testing before exceeding the aggregate volumes specified in the Order;

2. Use of personal protective equipment where there is potential for dermal exposure;

3. Use of a National Institute of Occupational Safety and Health (NIOSH)-certified respirator with an assigned protection factor (APF) of at least 1000 (where there is potential for inhalation exposure) or compliance with a NCEL of 0.2 mg/m 3 as an 8-hour time-weighted average;

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

5. Refraining from domestic manufacture in the United States ( i.e., import only); and

6. Use of the PMN substance only for the confidential use specified in the Order.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about environmental and health effects of the PMN substance may be potentially useful 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 that would be designated by this SNUR. The submitter has agreed not to exceed a certain production volume limit without performing specific reproductive toxicity testing and acute aquatic toxicity testing.

CFR citation: 40 CFR 721.11224.

Chemical Names: 2-pyridinecarboxylic acid, 6-(4-chloro-2-fluoro-3-methoxyphenyl)-4,5-difluoro-, phenylmethyl ester (P-16-246) and 2-pyridinecarboxylic acid, 4-amino-6-(4-chloro-2-fluoro-3-methoxyphenyl)-5-fluoro-, phenylmethyl ester, hydrochloride (1:1) (P-16-516).

CAS Numbers: 1391033-38-7 (P-16-246) and not available (P-16-516).

Effective date of TSCA section 5(e) Order: May 21, 2017.

Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be as chemical intermediates. Based on analysis of test data on analogous esters, EPA has identified concerns for carcinogenicity, developmental/reproductive effects, systemic toxicity, sensitization, and aquatic/terrestrial toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury human health and the environment. To protect against these risks, the Order requires:

1. Submission of certain toxicity testing on the PMN substances prior to exceeding the time limits specified in the Order;

2. Use of personal protective equipment where there is a potential for dermal exposure;

3. Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

5. Use of the PMN substances only for the confidential uses specified in the Order; and

6. No release of the PMN substances to surface waters.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substances may be potentially useful 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 that would be designated by this proposed SNUR. The submitter has agreed not to exceed certain time limits without performing sensitization, mutagenicity, reproductive/developmental, and carcinogenicity effects testing. EPA has also determined that the results of acute aquatic toxicity testing would help characterize the potential environmental effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and disposal will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citations: 40 CFR 721.11225 (P-16-246) and 40 CFR 721.11226 (P-16-516).

Chemical Name: 1,2,4-Benzenetricarboxylic acid, 1,2,4-trinonyl ester.

CAS Number: 1817723-10-6.

Effective date of TSCA section 5(e) Orders: June 22, 2018.

Basis for TSCA section 5(e) Orders: The PMNs state that the use of the substance will be used as a plasticizer for wire and cable insulation. EPA identified concerns for the PMN substance as a mild skin irritant as well as for blood, developmental, systemic, maternal, and male reproductive toxicity based on analysis of test data on analogous trimellitate esters. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance. To protect against these risks, the Orders require:

1. Submit to EPA certain toxicity testing before manufacturing (including import) a total of 1,750,000 kilograms (in each Order) of the PMN substance;

2. Submit to EPA additional toxicity testing which will be determined upon EPA review of the initial toxicity testing results;

3. Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS and worker training in accordance with the Hazard Communication section of the Orders;

5. Refraining from domestic manufacture in the United States ( i.e., import only); and

6. Use of the PMN substance only as plasticizer for wire and cable insulation.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful in support of a request by the PMN submitters to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. The submitters have agreed not to exceed certain production volume limits without performing reproductive/ developmental toxicity tests and aquatic sediment toxicity tests.

CFR citation: 40 CFR 721.11227.

Chemical Name: Aliphatic polyamines, polymers with bisphenol A and epichlorohydrin (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: July 23, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a hardener for epoxy coating. Based on the high percentage of amines and a high pH when in liquid formulation, EPA has identified concern for irritation to the eyes, skin, mucous membranes, and lungs. The Order was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the available information is insufficient to permit a reasoned evaluation of the human health effects of the PMN substances. To protect against these risks, the Order requires:

1. Use of the PMN substance only for the confidential use specified in the Order;

2. Use of personal protective equipment to prevent dermal exposure where there is potential for dermal exposure;

3. No use of the PMN substance in a consumer product; and

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of skin irritation and skin sensitization toxicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11228.

Chemical Name: Epoxy-amine adduct, methanesulfonates (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: June 11, 2018.

Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be open, non-dispersive. Based on physical/chemical properties of the PMN substances, EPA has identified concern for lung toxicity. Ecotoxicity hazards were identified based on structural analysis relationship (“SAR”) predictions for polycationic polymers. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

1. Refrain from manufacture, processing, or use of the PMN substances that result in inhalation exposure to vapor, mist, or aerosols;

2. Refrain from manufacture, processing, or use of the PMN substances for consumer use;

3. No release of the PMN substances from manufacturing, processing, or use resulting in surface water concentrations that exceed 208 parts per billion (ppb); and

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the physical/chemical properties, environmental and health effects of the PMN substances may be potentially useful to characterize the effects of the PMN substances 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 that would be designated by this proposed SNUR. EPA has also determined that the results of certain physical/chemical properties, acute aquatic toxicity testing, and pulmonary effects testing would help characterize the potential health effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions on manufacture, distribution in commerce, and use of these PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11229.

Chemical Name: Modified ethylene-vinyl alcohol copolymer (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: July 23, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the PMN substance will be for packaging applications. EPA identified concerns for lung effects if respirable particles are inhaled based on physical/chemical properties. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires refraining from manufacturing (which includes import), processing or using the PMN substance with particle size less than 50 microns.

The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information about health effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of specific pulmonary toxicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

CFR citation: 40 CFR 721.11230.

Chemical Name: Cashew, nutshell liq., polymer with acid and halohydrin (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: July 20, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as an adhesion application. Based on the presence of cashew, nutshell liquid in the PMN substance, EPA has identified concerns for sensitization from dermal exposure. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

1. Use of personal protective equipment including chemically impervious gloves and eye goggles where there is a potential for dermal exposure;

2. Use of a NIOSH-certified respirator with an APF of at least 50 to mitigate inhalation exposure and 1000 where the PMN substance has a use involving an application that generates vapor, mist, dust or aerosol;

3. No use of the PMN substance use in a consumer product; and

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of sensitization testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11231.

Chemical Name: Pentaerythritol ester of mixed linear and branched carboxylic acids (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: October 4, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the generic (non-confidential) use of the substance will be as a synthetic aircraft engine lubricant for contained use industrial lubricant. EPA identified concern for developmental, kidney, liver, and specific organ effects based on test data on the potential branch acid moiety hydrolysis product of the PMN substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

1. Use of personal protective equipment to prevent dermal exposure where there is a potential for dermal exposure;

2. Refraining from modifying the manufacture or processing of the PMN substance in a manner that results in inhalation exposure to the substance;

3. Use of the PMN substance only for the confidential use specified in the Order;

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and

5. No release of the PMN substance resulting in exceedance of a surface water concentration of 330 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information. EPA has determined that certain information about the environmental fate and health effects of the PMN substance would be potentially useful 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 that would be designated by this SNUR. EPA has also determined that the results of hydrolysis testing and reproductive/developmental toxicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require this test, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11232.

Chemical Name: Cashew nut shell liquid, branched polyester-polyether polyol (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: September 6, 2017.

Basis for TSCA section 5(e) Order: The PMN states that the use of the PMN substance will be as a polyurethane foam to raise concrete slabs. Based on the presence of cashew nut shell liquid, there is concern for sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health.

To protect against this risk, the Order requires:

1. Submit to EPA certain toxicity testing before manufacturing (including import) a total of 65,000 kilograms of the PMN substance;

2. Provide personal protective equipment to its workers to prevent dermal exposure, including impervious gloves where there is potential for dermal exposure;

3. Refraining from domestic manufacture in the United States ( i.e., import only);

4. Manufacture (including import) the PMN substance with no greater than 0.1% weight cashew nut oil;

5. Not use the PMN substance involving an application method that results in the generation of vapor, mist, or aerosol; and

6. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitters to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. The submitter has agreed not to exceed certain production volume limit without performing sensitization testing.

CFR citation: 40 CFR 721.11233.

Chemical Name: Methylene diphenyl diisocyanate terminated polyurethane resin (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: July 17, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a polyurethane used in an adhesive. Based on the isocyanate moiety, EPA has identified concerns for respiratory and dermal sensitization and lung and mucous membrane irritation. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I) based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance.

To protect against these risks, the Order requires:

1. Submitting to EPA the results of annual medical surveillance monitoring;

2. Use of personal protective equipment to prevent dermal exposure where there is potential for dermal exposure;

3. Use of NIOSH-certified respirators with an APF of at least 50 where there is potential for inhalation exposure;

4. No application methods of the PMN substance that generate a vapor, mist, aerosol, spray, or dust;

5. Refrain from manufacturing, processing, or using the PMN substance for consumer use or for commercial uses that could introduce the substance into a consumer setting; and

6. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful in support of a request by the PMN submitters to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this proposed SNUR. The submitter has agreed to perform annual medical surveillance monitoring as specified in the Order.

CFR citation: 40 CFR 721.11234.

Chemical Name: 2-Furancarboxylic acid, tetrahydro-.

CAS Number: 16874-33-2.

Effective date of TSCA section 5(e) Order: July 26, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a selective polishing agent for chemical mechanical planarization slurry for semiconductor wafer processing. Based on analysis of test data on an analogous chemical, EPA has identified concern for severe eye irritation, blood effects, reproductive effects, and immunotoxicity. Based on physical/chemical properties the substance is also expected to be corrosive, cause skin and eye burns, systemic effects, respiratory and digestive tract irritation with possible burns, pulmonary edema, solvent neurotoxicity, and solvent irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

1. Use of personal protective equipment involving impervious gloves and chemical safety goggles where there is potential for dermal exposure;

2. Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;

3. Refraining from domestic manufacture in the United States ( i.e., import only); and

4. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful to characterize the effects of the PMN 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 that would be designated by this proposed SNUR. EPA has also determined that the results of reproductive/developmental toxicity testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11235.

Chemical Names: Substituted heteromonocycle, homopolymer, alkyl substituted carbamate, substituted alkyl ester, substituted heteromonocycle, homopolymer, alkyl substituted carbamate, substituted alkyl ester (generic) (P-17-373) and polysiloxanes, di alkyl, substituted alkyl group terminated, alkoxylated, reaction products with alkanoic acid, isocyanate substituted-alkyl carbomonocycle and polyol (generic) (P-17-374).

CAS Numbers: Not available.

Effective date of TSCA section 5(e) Order: June 7, 2018.

Basis for TSCA section 5(e) Order: The PMNs state that the use of P-17-373 will be as an ultraviolet curable resin-overprint varnish and P-17-374 will be as an ultraviolet curable resin. Based on test data for structurally similar acrylates, EPA has identified concerns for eye and skin irritation, sensitization, mutagenicity, oncogenicity, liver and kidney toxicities. EPA also identified concern for developmental toxicity based on analogy to triethanolamines. Based on analogy to acrylates and carbamate esters, P-17-374 could cause environmental effects at concentrations of 110 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

1. Use of personal protective equipment to prevent dermal exposure where there is potential for dermal exposure;

2. Use of NIOSH-certified respirators with an APF of at least 50 where there is potential for inhalation exposure;

3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

4. Refraining from domestic manufacture in the United States ( i.e., import only);

5. Import of P-17-374 with no more than 0.1% residual isocyanate;

6. Import of the PMN substances to have a number average molecular weight of greater than or equal to 1000 daltons;

7. Refraining from using the PMN substances other than as an ultraviolet curable resin for coatings; and

8. No release of P-17-374 resulting in surface water concentrations that exceed 110 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substances may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of sensitization testing would help characterize the potential health effects of the PMN substances. Although the Order does not require this test, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11236 (P-17-373) and 40 CFR 721.11239 (P-17-374).

Chemical Name: Substituted carbomonocycle, polymer with substituted heteromonocycle and substituted polyalkylene glycol (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: June 21, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be for corrosion protection. Based on the physical/chemical properties of the PMN substance, analysis of test data, and structurally analogous epoxides, EPA identified concerns for mutagenicity, oncogenicity, developmental toxicity, male reproductive effects, liver and kidney toxicity, and dermal and respiratory sensitization. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

1. Refraining from domestic manufacture in the United States ( i.e., import only);

2. Refrain from using the PMN substance other than for primer coating for corrosion protection;

3. Import the PMN substance with an average molecular weight greater than 1000 daltons with no more than 10% less than 500 daltons and no more than 25% less than 1000 daltons;

4. Use of personal protective equipment to prevent dermal exposure where there is potential for dermal exposure;

5. Use of NIOSH-certified respirators with an APF of at least 1000 where there is potential for inhalation exposure; and

6. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of water solubility, acute and chronic aquatic toxicity, systemic toxicity, sensitization, and carcinogenicity testing would help characterize the potential health and environmental effects of the PMN substance. Although the Order does not require this information, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11240.

Chemical Name: Alkanedioic acid, polymers with alkanoic acid-dipentaerythritol reaction products, substituted alkanedioc acid, substituted alkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle and alkyl substituted alkanediol (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: July 26, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a binder for ultraviolet curable coating resin. Based on physical/chemical properties, data on the PMN substance, and analysis of test data on an analogous chemical, EPA has identified concerns for developmental toxicity, oncogenicity, liver and kidney toxicity, ocular irritation, sensitization, irritation/corrosion, and eye damage. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I) based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health or the environment. To protect against these risks, the Order requires:

1. Refraining from domestic manufacture in the United States ( i.e., import only);

2. Only use the PMN substance as a binder for ultraviolet curable coating resins;

3. Import the PMN substance with a number average molecular weight of greater than 1000 daltons;

4. Import the PMN substance with no greater than 20% of the acid moiety;

5. Use of personal protective equipment where there is potential for dermal exposure;

6. Use of a NIOSH-certified respirator with an APF of at least 1000 where there is a potential for inhalation exposure; and

7. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of water solubility, acute and chronic aquatic toxicity, systemic toxicity, sensitization, and carcinogenicity testing would help characterize the potential health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11241.

Chemical Name: Substituted carbomonocycle, polymer with diisocyanatoalkane, substituted alkylacrylate blocked (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: June 21, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as an ultraviolet curable resin. Based on physical/chemical properties, analysis of test data on the PMN substance, and structurally analogous acrylates, EPA has identified concerns for mutagenicity, oncogenicity, developmental toxicity, liver and kidney toxicity, dermal and respiratory sensitization. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I) based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

1. Refraining from domestic manufacture in the United States ( i.e., import only);

2. Refrain from using the PMN substance other than as an ultraviolet curable resin;

3. Import the PMN substance with an average molecular weight greater than 1390 daltons with no more than 11% less than 500 daltons and no more than 30% less than 1000 daltons;

4. Use of personal protective equipment to prevent dermal exposure where there is potential for dermal exposure;

5. Use of NIOSH-certified respirators with an APF of at least 1000 where there is potential for inhalation exposure; and

6. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of water solubility, acute and chronic aquatic toxicity, pulmonary toxicity, and sensitization, testing would help characterize the potential health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11242.

Chemical Name: 1,2-Ethanediol, 1,2-dibenzoate.

CAS Number: 94-49-5.

Effective date of TSCA section 5(e) Order: July 31, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a phlegmatizer (stabilizer for compounds susceptible to detonation) for peroxides for use with polyester and vinyl ester resins as well as with curable unsaturated polyester and methacrylic resins. Based on test data on the PMN substance, and analysis of test data on analogous chemicals, EPA has identified concerns for blood, liver, and kidney toxicity, neurotoxicity, immunotoxicity, and reproductive and developmental toxicity, and ecotoxicity. The Order was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based on a finding that the available information is insufficient to permit a reasoned evaluation of the health effects of the PMN substance. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health and the environment. Additionally, the Order was issued under 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonable be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance. To protect against these risks, the Order requires:

1. Use of personal protective equipment where there is potential for dermal exposure;

2. Use of a NIOSH-certified respirator with an APF of at least 25 where there is a potential for inhalation exposure;

3. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS;

4. Refraining from domestic manufacture in the United States ( i.e., import only);

5. Only use the PMN substance as a phlegmatizer (stabilizer for compounds susceptible to detonation) for peroxides for use with polyester and vinyl ester resins as well as with curable unsaturated polyester and methacrylic resins; and

6. No release of the PMN substance resulting in surface water concentrations that exceed 10 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of acute aquatic toxicity and neurotoxicity/developmental neurotoxicity/prenatal development testing would help characterize the potential health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11243.

Chemical Name: Alkenoic acid, reaction products with polymers with isocyanatoalkane and substituted alkanoic acid, substituted monoacrylate alkanoate-blocked (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: July 30, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as a waterborne ultraviolet curable coating resin binder for inkjet, ink, or overprint varnish. Based on physical/chemical properties, available data on the PMN substance and comparison to structurally analogous acrylates, EPA has identified concern for developmental toxicity, sensitization, irritation, corrosion, and eye damage. The Order was issued under TSCA section 5(a)(3)(B)(ii)(I) based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

1. Refraining from domestic manufacture in the United States ( i.e., import only);

2. Only use the PMN substance as a waterborne ultraviolet curable coating resin binder for inkjet, ink, or overprint varnish;

3. Import the PMN substance with no greater than 24% branched alkyl acid moiety content;

4. Import the PMN substance with no greater than 0.1% isocyanate content;

5. Use of personal protective equipment where there is potential for dermal exposure;

6. Use of a NIOSH-certified respirator with an APF of at least 1000 where there is a potential for inhalation exposure;

7. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS; and

8. No release of the PMN substance resulting in surface water concentrations that exceed 660 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health and environmental effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of water solubility, acute and chronic aquatic toxicity, developmental toxicity, and sensitization testing would help characterize the potential health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11244.

Chemical Names: Aromatic dicarboxylic acid, compd. with alkane diamines, polymer with alkane diamine and alkane dicarboxylic acid (generic) (P-18-71) and Aromatic dicarboxylic acid, compd. with alkyl diamines, homopolymer (generic) (P-18-79).

CAS Numbers: Not available.

Effective date of TSCA section 5(e) Order: July 6, 2018.

Basis for TSCA section 5(e) Order: The PMNs state that the generic (non-confidential) use of the substances will be as engineering thermoplastic. EPA identified concern for lung effects if the PMN substances are made with a particle size less than 10 microns based on analogy to similar poorly soluble particles. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(l)(A)(ii)(I) of TSCA, based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against this risk, the Order requires manufacture of the PMN substances with a particle size greater than 10 microns. The proposed SNUR would designate as a “significant new use” the absence of this protective measure.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substances would be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of pulmonary effects testing would help characterize the potential health effects of the PMN substance. Although the Order does not require this test, the Order's restrictions on manufacture, processing, distribution in commerce, and use of the PMN substances will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citations: 40 CFR 721.11245 (P-18-71) and 40 CFR 721.11246 (P-18-79).

Chemical Name: Aspartic acid, tallow modified diester (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: July 3, 2018.

Basis for TSCA section 5(e) order: The PMN states that the use of the substance will be as an intermediate used in the manufacture of a surface-active agent. Based on test data available for an analogue, EPA has identified concerns for irritation, blood effects, neurotoxicity and surfactant effects in the lungs based on analogue data. Based on SAR analysis of anionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

1. Manufacture, process and use of the PMN substance only as stated in the PMN submission;

2. Use only as an intermediate;

3. Refraining from modifying the manufacture, processing or use in a manner resulting in inhalation exposure;

4. Use of personal protective equipment to prevent dermal exposure (where there is potential for dermal exposure);

5. Establishment and use of a hazard communication program, including human health precautionary statement on each label and in the SDS;

6. That PMN residuals will be recycled back into the process as stated in the PMN; and

7. No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the environmental and health effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of acute aquatic toxicity, pulmonary effects, and specific target organ toxicity testing would help characterize the potential environmental and health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, processing, distribution in commerce, use, and disposal of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11247.

Chemical Name: Substituted alkanediol, polymer with heteromonocycles, alkenoate, metal complexes (generic).

CAS Number: Not available.

Effective date of TSCA section 5(e) Order: July 26, 2018.

Basis for TSCA section 5(e) Order: The PMN states that the use of the substance will be as an adhesion promoter for industrial application. Based on analysis of analogous acrylates, and physical/chemical properties, EPA has identified concerns for mutagenicity, oncogenicity, developmental toxicity, sensitization, irritation, and liver and kidney toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to health and the environment. To protect against these risks, the Order requires:

1. Use of personal protective equipment where there is a potential for dermal exposure;

2. Use of a NIOSH-certified respirator with an APF of at least 50 to mitigate inhalation and 1000 where the PMN substance has a use involving spray application;

3. Refraining from domestic manufacture in the United States ( i.e., import only);

4. Use of the PMN substance only as an adhesion promoter for industrial applications; and

5. Establishment and use of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the health effects of the PMN substance may be potentially useful 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 that would be designated by this proposed SNUR. EPA has also determined that the results of absorption, distribution, metabolism, elimination, genotoxicity, and sensitization testing would help characterize the potential health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions on manufacture, distribution in commerce, and use of the PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission of this or relevant information.

CFR citation: 40 CFR 721.11248.

During review of the PMNs submitted for the chemical substances that are subject to these proposed SNURs, EPA concluded that for all 28 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. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNURs would 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).

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

• EPA would 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.

• EPA would 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.

• EPA would 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.

• EPA would 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).

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.

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed 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 proposed 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 would be designated as significant new uses. The identities of 23 of the 28 chemical substances subject to this proposed rule have been claimed as confidential (per §§ 720.25) 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 proposed rule are ongoing.

Therefore, EPA designates March 19, 2019 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule. In developing this proposed rule, EPA has recognized that, given EPA's general practice of posting proposed rules on its website a week or more in advance of Federal Register publication, this objective could be thwarted even before Federal Register publication of the proposed rule.

Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of that date would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would 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.

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: Development of test data is required where the chemical substance subject to the SNUR is also subject to a rule, order or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)). In the absence of a TSCA section 4 test rule 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. lists potentially useful information identified by EPA that would help characterize the potential health and/or environmental effects of the PMN/SNUN substance for all of the listed SNURs. EPA recognizes that the 2016 Lautenberg Amendments have led to modifications in our approach to testing requirements, including an increased consideration of alternatives to vertebrate testing. Descriptions of tests/information needs are provided for informational purposes only and EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. 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 potentially useful information. EPA encourages dialogue with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). To access the OCSPP test guidelines referenced in this document electronically, please go to http://www.epa.gov/ocspp and select “Test Methods and Guidelines.” The Organisation for Economic Co-operation and Development test guidelines are available from the OECD Bookshop at http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.

In certain of the TSCA section 5(e) Orders for the chemical substances that would be regulated under this proposed rule, EPA has established production 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. Listings of the tests specified in the TSCA section 5(e) Orders are included in Unit IV. The proposed SNURs contain the same production 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 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.

Any request by EPA for the testing described in the 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/information 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 listed in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. 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.

According to § 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.

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2018-0650.

This proposed rule would establish 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).

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.

The information collection requirements related to this proposed rule 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, Collection Strategies Division, Office of Environmental Information (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.

Pursuant to section 605(b) of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ), the Agency hereby certifies that promulgation of this proposed SNUR would 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, and 14 in FY2017, 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 proposed 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.

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 proposed rule would 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. ).

This proposed rule would 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).

This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would 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.

This proposed rule 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.

This proposed rule 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 proposed rule is not expected to affect energy supply, distribution, or use and because this proposed rule is not a significant regulatory action under Executive Order 12866.

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

This proposed rule 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).

Therefore, it is proposed that 40 CFR chapter I be amended as follows: