July 1, Dear Sir or Madam,

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1 July 1, 2013 Air and Radiation Docket and Information Center Environmental Protection Agency Docket ID No. EPA HQ OAR Mail Code 2822T 1200 Pennsylvania Avenue N.W. Washington, DC Re: Comments of the National Corn Growers Association on Tier 3 Motor Vehicle Emission and Fuel Standards, Proposed Rule, published at 40 CFR Vol. 78 No. 98, May 21, 2013 Docket ID No. EPA HQ OAR Dear Sir or Madam, The National Corn Growers Association (NCGA) is the largest trade association of corn growers in the United States and represents more than 39,000 dues paying corn farmers nationwide and the interests of more than 300,000 growers who contribute through corn check off programs in their states. NCGA is the voice for the corn growers concerns in national legislative, judicial and regulatory agencies decisions affecting agriculture. Our members live and farm in 47 states. Our national headquarters is located in St. Louis, Missouri and NCGA also maintains an office in Washington, D.C. Farmers have responded to the increased demand of corn for ethanol while continuing to meet the demand in all other sectors, namely, feed, food and export. Corn was used to produce 13.3 billion gallons of ethanol and 34.4 million metric tons of high quality livestock feed (distillers grains and corn gluten feed and meal) in 2012 for the nation s economy. 1 This level of ethanol production for fuel represents 10 percent of the nation s gasoline supply that can be found in more than 96 percent of all gasoline sold. There are many benefits of ethanol in the fuel supply including, but not limited to: improved energy security, reduced greenhouse gas (GHG) emissions, reduced oil imports, reduced gasoline prices, and thousands of U.S. jobs, just to name a few. NCGA s members remain committed to providing this important source of energy for U.S. drivers. The corn crop will also play an important role in the future, providing feedstock for cellulosic ethanol and animal feed supplements, through the use of millions of tons of available corn stover. 2 NCGA appreciates the opportunity to comment on the Tier 3 Motor Vehicle Emission and Fuel Standards Proposed Rule. We commend the Agency on the proposed rule, which will reduce criteria pollutants from the on-road light-duty motor vehicle fleet for many years to come. We also commend the agency on its recognition of the benefits of ethanol in transportation fuel, and its continued support for the Renewable Fuel Standard regulation, which is significantly 1 Pocket Guide to Ethanol 2013, Renewable Fuels Association, 2

2 reducing GHG emissions and improving energy security in the United States through the use of domestically produced ethanol. Our comments on the Tier 3 proposal are based on two principles: 1. The first principle is that the RFS volume of biofuels in the future should be met in order to preserve the 150 million metric tons of annual CO2 equivalent emission reductions attributed to the RFS 2 program by EPA. 3 These emission reductions are directly dependent on the production of biofuels and not on the fuel economy of the light-duty on-road motor vehicle fleet. The volume of biofuels utilized is in turn dependent on having vehicles that are flexible-fuel capable and those certified on high octane midlevel blends plus a retailer infrastructure offering energy-competitive pricing. The Tier 3 proposal thus has a direct bearing on the availability of vehicles to implement the RFS. 2. The second principle is that ethanol blends above E10 should be splash blended to increase octane above the level of 87 Anti-Knock Index (AKI). 4 This will provide higheroctane fuels (not higher priced premium grade fuels) to be widely used by the motoring public and by the automakers in meeting the 2017 and Later Model Year Light- Duty Vehicle GHG and Corporate Average Fuel Economy (CAFE) Standards. We are supportive of the EPA s approach toward establishing E15 as the new certification fuel for 2017 and later non-flexible fueled light duty vehicles and the lower sulfur specifications for in-use gasoline. Further, we support the recognition that a high octane mid-level ethanol blend (MLEB) would help automakers achieve the 2017 and later GHG and CAFE standards. And, while we are generally supportive of establishing new certification fuel requirements for FFVs, we are concerned that the proposed approach would inhibit future development of FFVs and the development of dedicated vehicles designed for the exclusive use of an high octane MLEB. Both FFVs and high octane utilizing vehicles are critical to ensuring that the 150 million metric tons of GHG emission reductions from the RFS volumes are attained. We also provide comments on EPA s stated plan to develop an assessment of the health effects of exposure to ethanol in Appendix A. Our comments are organized into the following sections: Test fuels In-use fuels 1.0 Test Fuels 3 Renewable Sulfur Standard (RFS2) Regulatory Impact Analysis (EPA-420-R ), February EPA s statement is as follows: There are however, based on the biofuel use replacing petroleum fuels, annual reduction benefits of 150 million metric tons of CO2-eq emissions. 4 The octane value of gasoline sold at retail is identified as the average of research octane number (RON) and motor octane number (MON), or (R + M)/2. RON and MON are determined by different tests of engine operation. The average of RON and MON is referred to as the Anti-Knock Index or AKI. 2

3 EPA has proposed specifications for test fuels for non-ffvs and FFVs. In addition, EPA has indicated that automakers could petition EPA to use a high octane MLEB alternative certification test fuel. 1.1 E15 Emission Certification Test Fuel EPA has proposed changing the certification test fuel from one containing no ethanol to E15 with a volatility of 9 psi and an AKI of 87. Ethanol Content of Tier 3 Certification Fuel Separate from the Tier 3 rule, EPA approved the use of E15 in 2001 and later on-road motor vehicles. 5 It would not make sense to certify new motor vehicles on E0, or even E10, when EPA has approved the use of E15 in these vehicles. Nearly all vehicles in the United States are currently fueled with E10, and the RFS volume requirements will increase the renewable fuel content in the United States beyond today s levels. Therefore, it is important that the 2017 and later model year vehicle fleet be certified on the expected future ethanol content rather than the historic ethanol content. We believe E15 certification test fuel should be introduced for the 2017 vehicle model year as EPA has proposed. In view of the long history of ethanol use as E6, E10 and E85, the understanding of materials compatibility and engine and emission impacts of ethanol blends in the literature for 30 years, it seems that a phase-in schedule might not be required to design and calibrate for E15. EPA discussed potential delays in the introduction of E15 test fuel to allow auto manufacturers to make calibration adjustments. While phase-in schedules or trigger points may be necessary and appropriate in some situations, we believe it would reduce complexity and improve market certainty to require the introduction of E15 test fuel for the 2017 model year as EPA has proposed. A specific model year requirement such as 2017 provides a 3-year lead time for vehicle design and calibration changes. This would also provide important certainty for fuel providers, marketers and distributors that a trigger point approach would not provide. Perhaps more importantly, implementation in the 2017 model year would eliminate the need for an interim E10 test fuel and the related complexity and potential vehicle modifications associated with a second test fuel transition. Vapor Pressure of Tier 3 Test Fuel We concur with EPA s proposed 9 psi vapor pressure specification for an E15 test fuel. The current vapor pressure specification for Tier 2 vehicles is also 9 psi. However, we recommend 5 Partial Grant of Clean Air Act Waiver Application Submitted by Growth Energy To Increase the Allowable Ethanol Content of Gasoline to 15 Percent; Decision of the Administrator, FR Vol 76, Number 17, Wednesday, Jan 26,

4 that in-use ethanol blends between E11-50 be allowed a 1 psi waiver, as applied to E10. Our rationale is further discussed within the In-Use Fuel section of these comments. We do not believe that a 1 psi waiver for E11-E50 necessitates a vapor pressure specification greater than 9 psi for E15 certification fuel, any more than E10 (which has a 1 psi waiver) does for the current certification gasoline. Reformulated Gasoline (RFG) areas and non-rfg areas without a waiver currently have less than 9 psi fuel in the summer; vapor pressure greater than 9 psi only occurs in non-rfg areas with a waiver. EPA did not propose further volatility controls for in-use fuel as a part of the Tier 3 fuel requirements. If EPA were concerned about the emission increases of Tier 3 (or even Tier 2) vehicles certified on 9 psi fuel and operated on 10 psi in the summer, it would have done so as a part of its fuel proposal. EPA points out in the Tier 3 proposal that vapor generation in motor vehicles using 10 psi fuel in the summer is 25% higher than with 9 psi fuel. However, this does not mean that vehicle emissions are increased by 25% because modern vehicle evaporative emission control systems are designed to capture emissions for a 3-day park at high temperatures. The Tier 3 evaporative emission standards represent a very high level of evaporative emission control, whether the vehicles are operated on 9 psi fuels or in some areas of the country, 10 psi. Octane Content of Tier 3 Test Fuel Ethanol has a high octane value which has allowed gasoline refiners to supply gasoline blendstock for blending with ethanol at levels significantly below 87 AKI, typically 84, such that the finished gasoline meets the 87 octane minimum requirement. Virtually all E15 sold at retail today is made using the same 84 AKI octane base gasoline, resulting in a higher blended octane in the range of 88.5 to 90 AKI. EPA has proposed an 87 to 88.4 octane range for Tier 3 test fuel. We believe the E15 certification fuel octane should reflect the octane of retail E15, ensuing that the octane value of ethanol will continue to be used to raise the octane of finished gasoline above 87 AKI. Our recommendation is that EPA establishes an octane range of 88.5 to 90 AKI for E15. This would also be consistent with an incremental improvement in fuel economy and GHG emission performance of modern vehicle electronic emission control systems to this increase in octane. 1.2 High Octane E30 Alternative Certification Test Fuel EPA suggested the concept of producing dedicated E30 vehicles or FFVs optimized to run on E30 or higher alcohol blends. NCGA supports fuels with higher octane and higher ethanol amounts that provide a pathway to improved vehicle efficiency and lower GHG emissions. It is important to establish the composition of a new fuel early to facilitate design and optimization. NCGA recommends two options for the base gasoline blendstock for oxygenate blending (BOB) and several options for ethanol content. For base gasoline or BOB, the options are conventional gasoline BOB or CBOB, an 88 research octane (RON) hydrocarbon that becomes regular E10 when blended with 10 percent ethanol, and a high octane premium gasoline BOB or PBOB, a RON hydrocarbon that becomes premium E10 when blended 4

5 with 10% ethanol. Although EPA mentions 30 percent ethanol as a candidate blend, other ethanol blend rates such as E25 or E35 may represent a more optimum blend for vehicle and engine design. NCGA does not believe that the alternative test fuel provisions at (c) are practical since they assume that a new fuel would become widely available prior to the availability of vehicles designed to use it. Further, a specification for the new fuel is needed ahead of time as a guide for fuel providers and auto manufacturers. Were EPA to determine that some sort of actual use demonstration of the high octane high ethanol fuel is required, NCGA would look to recent EPA guidance on this subject. EPA, in its Draft Guidance for E85 Flexible Fuel Vehicle Weighting Factor for Model Year Vehicles, 6 stated that the F-Factor (proportion of actual use) must be based on the projected use of the alternative fuel over the life of the vehicles. If the determination of the amount of alternative fuel used requires the vehicles to reach full useful life first, then it is clear that EPA will have to offer guidance on what this F-Factor value would be because of the uncertainty of this value. EPA has the authority to ensure the availability of this new fuel formulation as the vehicles designed to use it become available if it believes such a fuel would enable meeting the 2017 and Later Model Year CAFE and GHG Emission regulation and the RFS regulation. 7 Consistent with EPA s expressed belief that improved engine efficiency and reduced GHG emissions would result from a high octane MLEB and engines designed for its use, we recommend that EPA consider requiring the nationwide availability of such a high octane fuel. Perhaps a more workable alternative would be to require a phase-in of all gasoline fueled light duty vehicles as FFVs beginning in 2017 (50% in 2017 and 100% in 2018). 8 This approach would clearly communicate EPA s support for the GHG reduction benefits of the RFS program, and would clear the way for FFVs to become the bridge to a new generation of vehicles designed and optimized to run on a higher octane MLEB. Requiring 2017 and later gasoline vehicles to be FFVs would remove any limits on ethanol usage, and would provide a clear incentive to service station owners to offer more gasoline/ethanol fuel choices through the use of blender pumps. One of the key impediments to additional biofuel use is the number of vehicles with flexible fuel capability to use blends above E15. With a current penetration of about 18 million vehicles, FFVs are still significantly less than 10% of the vehicle fleet. E85 is sold in approximately 3,000 service stations, less than 10 percent of the 165,000 stations, not nearly enough to support increased ethanol consumption volumes under the RFS. It is our belief that if EPA required 2017 and later vehicles to be certified as FFVs, automakers would more seriously consider petitioning EPA for a high octane MLEB. A preferred MLEB for both consumers and automakers would then likely emerge from this process. An FFV requirement would also eliminate any non-ffv 6 EPA draft guidance. 7 P. Machiele, Statutory and Regulatory Backdrop for Fuel Standards, January 28, 2013, presentation at SAE Hi Octane Symposium. 8 Vehicles certified to a mid-level blend fuel should also qualify as meeting this requirement. 5

6 misfueling concerns with the 2017 and later fleet. Finally, requiring gasoline vehicles in 2017 and later model years to be FFVs would significantly enhance energy security in the United States by encouraging the use of renewable, domestically produced fuels. R Factor Used in Fuel Economy Calculation Fuel economy testing originated in 1975 using the FTP-75 procedure and a pure hydrocarbon certification fuel with a specific gravity of and a carbon weight fraction of EPA is required to provide average fuel economy adjustments for test procedure changes that would cause a vehicle to achieve fuel economy results different from those that would be achieved under the 1975 test procedure. Changes in test fuel energy content qualify as a test procedure change that requires an adjustment. EPA has proposed new certification fuels containing ethanol with slightly lower net heating values on a per gallon basis. A simple way to adjust for energy content for vehicles not designed and optimized to use a mid-level blend high octane fuel is to use a ratio of the volumetric energy content of the new test fuel to that of the 1975 test fuel. EPA has proposed this approach in the past However, 30 years ago when EPA originally corrected for fuel changes, vehicle technology did not fully compensate for fuel energy changes. EPA modified the approach by adding the R-Factor which may be considered as the efficiency with which the vehicle engine adapts to fuel energy variations. A factor of 0.6 was derived from data gathered from vehicles from the 1970s and early 1980s. An R-Factor less than 1 implies the vehicle is less efficient on fuels with higher energy content than the 1975 test fuel and more efficient on fuels with lower energy content than the 1975 test fuel. EPA first applied the equation containing the R-Factor of 0.6 to a test fuel with oxygenates, California Phase 2 gasoline, in In applying the 0.6 R-Factor EPA acknowledged Data indicate that this [corrected] mpg value is partially corrected for the difference in fuel properties between Phase 2 test fuel and the 1975 EPA test fuel. 12 The R-Factor of 0.6 was derived from vehicles that are now over 30 years old and nearly 20 years ago EPA acknowledged that the 0.6 value did not fully compensate for the fuel energy change and needed to be revised. Nonetheless, the factor of 0.6 is still in use today. Recent test data indicate a somewhat higher R-Factor than 0.6. The Auto-Oil test program on 1989 model year vehicles 13 determined an R-Factor value of approximately More recently, The U.S. Department of Energy published its own analysis indicating values ranging from 0.92 to For virtually all vehicles evaluated, the 95% confidence intervals shown 9 Impact of Gasoline Characteristics on Fuel Economy and its Measurements, JLB. 10 Corrections for Variations in Test Fuel Properties, EPA-AA-SDSB EPA Dear Manufacturer Letter CD Ibid. 13 A. Hochhauser et al., Fuel Composition Effects on Automotive Fuel Economy-Auto/Oil Air Quality Improvement Research Program, SAE paper , SAE International, March S. Sluder and B. H. West, (2013) Preliminary Examination of Ethanol Fuel Effects on EPA s R-factor for Vehicle Fuel Economy; (2013). 6

7 include the 1.0 value that EPA initially proposed in The authors noted that: Additionally, there is uncertainty present in the ASTM results for heating value, carbon weight fraction, and specific gravity that have not been included in the confidence intervals. Inclusion of these uncertainties would increase the confidence intervals. Of course, in all these tests, the vehicles tested were not designed for a higher octane mid-level blend. We request that EPA review the R-Factor and determine whether the use of the value of 0.6 would be an impediment to automakers to petitioning EPA for the use of a MLEB as a certification fuel and revise the R factor as necessary. 1.3 Flexible Fuel Vehicle Test Fuel We support the development of specifications for FFV certification test fuel. As the RFS requirements ramp up beginning in 2015 and later, we believe the incentive will increase to produce more ethanol-containing fuels, and that E85 use in FFVs is likely to increase. Now that ASTM has published and refined its ASTM 5798 Flex Fuel specification, it is reasonable to provide a more complete and comprehensive specification for the FFV certification test fuel. EPA proposed the E85 ethanol test fuel concentration be limited to E80-E83 and that this could be achieved by blending ethanol into E15 test fuel utilizing denatured fuel ethanol or neat ethanol. EPA also indicated that the vapor pressure of the test fuel should be between 6.0 and 6.5 psi. However, we are concerned that EPA s specification of E85, at E80-E83 with a vapor pressure of 6.0 to 6.5 psi, could inhibit the development of FFVs meeting the lowest NMOG+NOx standard bins of the Tier 3 proposed rule. We recommend that EPA consider the unique challenges and additional costs of designing FFVs to comply with Tier 3 Bin 20, 30 and 50 standards, and not create FFV test fuel specifications that unnecessarily increase the stringency of the emission standards and discourage production of FFVs. We are aware that the U.S. Department of Energy National Renewable Energy Laboratory and the Coordinating Research Council are beginning another field survey of E85 to compare the fuel quality to the most recent ASTM D specification. 15 We recommend that EPA use information from this survey to select specifications for FFV test fuel from the data rather than selecting a specification such as E In-Use Fuel 2.1 Non-FFVs EPA proposed a 10 ppm sulfur cap for gasoline and did not lower gasoline volatility from current levels. No reduction in vapor pressure from current levels reflects the fact that gasoline 15 CRC Project no. E-85-3, E-85/E-85-2/E-85-3 National Surveys of E85/Flex Fuel Quality, project description available at 7

8 volatility in RFG areas is already quite low and that evaporative emissions from the current vehicle fleet is controlled and will be controlled even further through the proposed Tier 3 evaporative emission standards. A 1 psi waiver for E10 exists in many non-rfg areas that have not prohibited the waiver. For these reasons, NCGA believes the 1 psi waiver should be extended to E11-E15 fuels as well. Extending the waiver to E11-E15 blends would allow currently used E10 gasoline blendstocks to be used for E15 blending, eliminating the need for a special low vapor pressure blendstock for non-rfg areas. This would improve the nationwide marketability of E15 and facilitate its replacement of E10. As the following chart shows, the vapor pressures of ethanol blends in the range of E10 to E15 are nearly equivalent. As a result, evaporative emissions for E11 to E15 would be similar to E10. SAE paper , "Volatility Characteristics of Gasoline-Alcohol and Gasoline-Ether Fuel Blends." 2.2 Standards for Denatured Fuel Ethanol (DFE) EPA proposed that manufacturers of DFE for use by oxygenate blenders meet a 10 ppm sulfur cap, and that only natural gasoline, gasoline, and gasoline blendstocks for oxygenate blending (BOB) be used as ethanol denaturants. NCGA supports EPA s proposal for DFE standards. We believe it would be unnecessary and burdensome to adopt California s additional specifications for DFE. 2.3 FFVs EPA divided its proposal for in-use fuels for FFVs into two levels by ethanol concentration: E51-83 and E16-50 (or MLEBs). 8

9 For E51-83, EPA proposed that these blends meet the same sulfur, vapor pressure, and benzene standards otherwise applicable to gasoline as well as the Clean Air Act substantially similar requirements. EPA expressed the belief that establishing such requirements could allow the use of butane and natural gasoline liquids to manufacture E51-83 with sufficient volatility to meet the ASTM specifications. We support specifications that are consistent with ASTM D , and allowing the use of blendstocks such as NGL, butane and others that would permit compliance with ASTM D For E16-E50, EPA proposed that these blends meet the same standards that apply to gasoline. EPA also requested comments on whether it might be an appropriate reading of our regulatory and statutory authority to allow E16 to E50 blends to have higher RVP levels than otherwise required by our regulations for gasoline. EPA went on to say: As the ethanol level increases the volatility increase caused by blending ethanol with gasoline begins to decline, such that at E30 there is only about a 0.5 psi vapor pressure increase. While still an increase compared to the standards that apply to gasoline other than E9-E10, it is considerably less than the full 1 psi vapor pressure increase that results at E10. The evaporative emission increase caused by E30 would be then be less than that for E NCGA believes that EPA should use its regulatory and statutory authority to allow E16-50 blends to have higher vapor pressures, so that gasoline blendstocks used currently for E10 could also be used for E16-E50, and these MLEBs could be used in current FFVs. This is critical to the success of high octane MLEBs, since it would facilitate distribution of a high octane MLEB that could likely be requested by automakers to meet the 2017 and later GHG and CAFE standards. At least two major automakers have reported research programs evaluating advanced technology gasoline direct engines with high octane MLEBs. 17,18 In summary, we urge EPA to ensure that the Tier 3 fleet is designed for forward-looking fuels such as E15, that the Tier 3 rule encourages the continued production of FFVs, and encourages the production of vehicles certified on high octane MLEBs, thereby preserving the GHG benefits of the RFS. We also urge EPA to extend a 1 psi waiver to all ethanol blends above E10, since doing so would have virtually no negative air quality impact and would result in increased consumption of biofuels reducing GHG emissions. Thank you for the opportunity to comment on the Tier 3 Motor Vehicle Emission and Fuel Standards Proposed Rule FR 29938, May 13, McCarthy, T Fuel Octane and Ethanol Impacts on Petroleum Displacement, CO2, and the Consumer, Ford Motor Company, presentation at SAE High Octane Fuel Symposium, January 29, Woebkenberg, W, Advanced Powertrain Technology Coupled with Octane and Ethanol, Benefits and Opportunities, SAE High Octane Fuels Symposium, January 29,

10 Sincerely, National Corn Growers Association Illinois Corn Growers Association Indiana Corn Growers Association Iowa Corn Growers Association Michigan Corn Growers Association Minnesota Corn Growers Association Missouri Corn Growers Association Nebraska Corn Growers Association North Dakota Corn Growers Association South Dakota Corn Growers Association 10

11 APPENDIX A The health impacts of ethanol should not be a serious concern in the Tier 3 Rulemaking The proposed rule indicates that: Jon M. Heuss, Air Improvement Resource June 13, 2013 EPA is planning to develop an assessment of the health effects of exposure to ethanol, a compound which is not currently listed on EPA s IRIS database. Extensive health effects data are available for ingestion of ethanol, while data on inhalation exposure effects are sparse. In developing the assessment, EPA is evaluating pharmacokinetic models as a means of extrapolating across species (animal to human) and across exposure routes (oral to inhalation) to better characterize the health hazards and dose-response relationships for low levels of ethanol exposure in the environment. 19 The potential for health effects due to ethanol exposures associated with its use in motor vehicle fuel were extensively evaluated a number of years ago by several organizations. The California EPA, 20 the Health Effects Institute (HEI), 21 and several other groups 22 evaluated ethanol as a replacement when problems associated with the gasoline additive, methyl tertiarybutyl ether (MTBE), became apparent. All these analyses have concluded that the exposures to ethanol from its use as a motor vehicle fuel are very unlikely to have any adverse consequences. Although it is well established that relatively high doses of ingested ethanol and high blood levels of ethanol associated with the consumption of alcoholic beverages have toxic effects in humans, the amount of alcohol absorbed from the low doses of environmental ethanol is extremely small in comparison. In fact, the small doses that may be experienced are the same order of magnitude as naturally-occurring levels of ethanol in blood. In addition, ethanol is readily degraded in the environment, both in air and in water so it will not accumulate to levels of concern. These findings provide strong evidence that environmental exposures to ethanol will have no adverse health impact Federal Register 29386, May 21, California Environmental Protection Agency, Potential Health Risks of Ethanol in Gasoline, Office of Environmental Health Hazard Assessment, December Health Effects Institute (HEI) (1996). The Potential Health Effects of Oxygenates Added to Gasoline: A Review of the Current Literature. HEI: Cambridge, MA. 22 P. Andersson and K. Victorin, (1996). Inhalation of Ethanol: Literature Survey and Risk Assessment. IMM- rapport 3/96. Institutet for Miljomedicin (Institute of Environmental Medicine), Karolinska Institute: Stockholm, Sweden; Sarah R. Armstrong, ETHANOL Its Use in Gasoline: Expected Impacts and Comments of Expert Reviewers, Cambridge Environmental Inc., April 5,

12 The California analysis included detailed modeling of the ambient ethanol exposures for several fuel variations 23 and comparisons of the results to levels of concern developed by the Office of Environmental Health Hazard Assessment (OEHHA). 24 The modeled incremental ambient ethanol concentrations were in the range of 5 to 100 ppb. The OEHHA health protective concentration (HPC) was 53 ppm. It was derived from a study that reported a lowest effect level of 5300 ppm for sensory irritation from inhaled ethanol in normal healthy subjects. OEHHA applied an uncertainty factor of 100 to derive the 53 ppm (53,000 ppb) health protective level. When the modeled ambient levels were compared to the acute and chronic non-cancer HPCs, OEHHA concluded that modeled concentrations are at least 500-fold below the HPCs. This led OEHHA to conclude that health effects due to ethanol exposure are not expected to occur. OEHHA also evaluated the potential for cancer and concluded that there is no evidence that ethanol is carcinogenic via the inhalation route even though heavy consumption of alcoholic beverages is known to be associated with increased incidences of some cancers, including those of the oral cavity and of the liver. OEHHA noted that ethanol was considered by the Proposition 65 Science Advisory Panel, who reviewed the evidence as to the carcinogenic and cocarcinogenic effects of ethanol in humans and animals. The Panel specified the listing of alcoholic beverages, when associated with alcohol abuse as carcinogenic in July The 1999 OEHHA report followed this assessment in concluding that, whereas high levels of chronic exposure to ethanol are carcinogenic to humans, the levels of ethanol predicted to occur in air or water as a result of its use in gasoline were unlikely to result in a cancer risk to the exposed population. 25 The Health Effects Institute carried out a thorough review of the information on exposures to and health effects from various oxygenates including ethanol. In agreement with CalEPA, the HEI Committee concluded that it was unlikely that the low exposures to ethanol would cause any health effects. For example, the Health Effects Institute review included estimates of incremental blood level increases for two refueling exposure: a typical refueling scenario, 1 ppm for 3 minutes, and an extreme exposure scenario, 10 ppm for 15 minutes. The HEI Panel concluded: Even the extreme scenario is expected to result in an incremental blood level that is insignificant compared with the endogenous blood levels resulting from normal metabolism. 26 The HEI Committee concluded that in exposure scenarios encountered by the general public, it is unlikely that an increase in ethanol blood levels will be measurable and that health effects 23 California Environmental Protection Agency, Air Resources Board, Air Quality Impacts of the Use of Ethanol in California Reformulated Gasoline, Final Report to the California Environmental Policy Council, December California OEHHA report, supra note Ibid., at page A-14 and A HEI report, supra note 3, page

13 from exposure to ambient levels of ethanol are unlikely because endogenous blood ethanol levels are not predicted to increase significantly from inhaling ethanol in fuel. In addition to the findings of the extensive reviews by HEI, CalEPA and others, the U. S. EPA has not considered ethanol as an air toxic of concern in its recent evaluations and rulemakings. For example, the Agency did not include ethanol in a group of 177 air toxics compounds that were evaluated in the most recent National-Scale Air Toxics Assessment. 27 Ethanol was not explicitly considered in the February 26, 2007 Mobile Source Air Toxics Rulemaking. 28 When EPA first announced its interest in removing MTBE, the Agency understood that: Given that ethanol is formed naturally in the body at low levels, inhalation exposure to ethanol at the low levels that human are likely to be exposed are generally not expected to result in adverse health effects. 29 Although the EPA IRIS database does not currently include ethanol, there has been a 1,000 ppm occupational standard for ethanol for decades. The 1,000 ppm 8-hour time-weighted average standard was set to provide a no-effect level for irritation in the occupational setting. An additional relevant study is available. Nadeau, et al., specifically evaluated possible neuromotor effects of six-hour exposures to 0, 250, 500, and 1,000 ppm ethanol to healthy non-smoking adult males in a controlled environment exposure chamber. Nadeau et al. report no significant differences in body sway, hand tremor, or reaction time between exposed and non-exposed conditions. In addition, ethanol was not detected in blood or in alveolar air when volunteers were exposed to 250 and 500 ppm. At 1,000 ppm, the blood alcohol concentration was 0.4 mg/dl. For comparison, the legal limits for drivers are usually 80 to 100 mg/dl and the peak blood alcohol for an adult male consuming a typical alcoholic beverage containing 12 g of alcohol is on the order of 25 mg/dl. Given the extremely low doses of alcohol from inhalation of ambient ethanol, the health impacts of ethanol should not be a serious concern in the Tier 3 Rulemaking. 27 List of Air Toxics in the 2005 NATA Assessment, from the 2005 NATA released March 11, Available at Federal Register 8428, February 26, Federal Register 16094, March 24, 2000, at V. Nadeau, D. Lamoureux, A. Beuter, M. Charbonneau, and R. Tardif, Neuromotor effects of acute ethanol inhalation exposure in humans: a preliminary study, J. Occup. Health, 45, (2003). 13