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 BEFORE THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY National Ambient
Air Quality Standards for Ozone: COMMENTS The Society of the
Plastics COMMENTS ON THE PROPOSED NATIONAL AMBIENT AIR QUALITY STANDARDS FOR OZONE The Society of the Plastics Industry, Inc.1 (SPI) is pleased to provide these comments in response to the U.S. Environmental Protection Agency's ("EPA" or "the Agency") proposal to revise the National Ambient Air Quality Standards (NAAQS) for ozone.2 Many SPI members are subject to regulations imposed by states to ensure compliance with the Clean Air Act's NAAQS and, therefore, will be affected by this proposed regulation. SPI members operate facilities that emit nitrogen oxides (NOx) and volatile organic compounds (VOCs), which are ozone precursors. As a result, SPI and its members have a direct and substantial interest in this rulemaking. INTRODUCTION SPI opposes EPA's proposed decision to increase the stringency of the ozone air quality standard for a number of reasons. Most significantly, SPI believes that EPA's proposed decision to change the ozone standard is not supportable by the health effects data. Specifically, SPI objects to the proposed rule because:
Before EPA finalizes this proposed rule, we strongly urge the Agency to take the following steps:
EPA proposes to lower the primary and secondary ozone standards, change the duration over which ozone peak concentrations are measured, and change the manner by which attainment is calculated. Specifically the proposal would make the following changes:
The Clean Air Scientific Advisory Committee (CASAC), the expert review panel established under the Clean Air Act to advise the Agency, concluded that, after carefully reviewing the technical and health analyses, it could find no health basis to revise the current ozone NAAQS. SPI agrees with CASAC's conclusion and supports the maintenance of the current NAAQS for ozone. Should EPA decide to adopt the 8-hour averaging technique, SPI strongly encourages EPA to adopt 0.09 ppm, which the Agency indicates is approximately equivalent to the current level of 0.12 ppm over 1 hour. This level is consistent with the recommendation of five members of the CASAC 4 and is within the range of values presented by the EPA staff as providing increased margin of safety for at-risk populations. 5 SPI supports environmental regulations that are based on sound science and that address real public health or environmental problems. SPI is opposed to regulation if the need for that regulation has not been adequately validated or if the problems the regulation is intended to address have not been adequately defined. SPI is opposed to this proposal, which will impose great costs on our members, because it is premature. It does not appear that EPA is able to support this decision because insufficient current available data exists that would allow it to do so. The CASAC found that the data did not show that EPA's proposed ozone standard was significantly more protective of public health than the current standard. EPA, therefore, should not finalize the proposed decision without further justification. The proposed revision fails to take into account the background ozone levels that would occur even in the absence of all man-made contributions to ozone. Natural emissions from trees and other vegetation can release sufficient VOCs to reach almost 0.07 ppm. In fact, 8-hour daily average levels of 0.072 ppm have been recorded in a national park in North Dakota, 6 hardly a place where man-made emissions contribute significantly to ozone concentrations. The CASAC noted that
Because the scientific data do not clearly indicate a threshold, EPA must make a policy choice. SPI urges the Agency to retain the current standard because the CASAC found no health basis for revising it. CURRENT STANDARDS SUFFICIENTLY PROTECTIVE OF HEALTH The CASAC found the current primary NAAQS, based on acute effects associated with heavy exercise and short-term exposures, to be sufficiently protective of human health. Despite this finding, the proposal suggests a more stringent standard. Although chronic effects have been identified in animal studies, effects from long-term exposure have not been adequately established in human studies to draw any conclusions and extrapolating from animal studies to human health effects introduces a host of uncertainties. Chronic effects, therefore cannot be used to justify a more stringent standard. In addition to finding the current standard adequate and the proposed standard not significantly more protective, in its concluding comments to the Agency, the CASAC found that
Thus, since there is no threshold level below which biological effects are observed, sensitive persons will always experience health effects regardless of the ozone NAAQS. The Agency cannot control natural sources and should not control below the current standard because it is too close to background levels and is sufficiently protective of human health. Section 109(b)(1) of the Clean Air Act defines the primary standard as one "the attainment and maintenance of which in the judgment of the Administrator, based on criteria and allowing an adequate margin of safety, [is] requisite to protect the public health." According to EPA, the margin of safety is intended to address uncertainties associated with inconclusive scientific and technical information and to protect against hazards not yet identified. EPA apparently is taking the position that the "margin of safety" allows the Agency to expand upon the available data. Contrary to that assertion, the Agency is required to base its decisions on reasonable extrapolations from reliable data.9 Indeed, although the Agency "may err on the side of overprotection . . . [it] may not engage in sheer guesswork." 10 The Agency must support its conclusions with a reasoned analysis and evidence of risk contained in the record.11 As the CASAC acknowledged, the data used to support the proposed rule are inconclusive. As a matter of policy, the Agency should not base its regulatory standards on inconclusive data particularly in light of CASAC finding the current standard adequate. When -- and if -- the Agency has more conclusive data, it can amend the standard. NO ADVERSE HEALTH EFFECTS FROM LONG-TERM EXPOSURE According to the human studies relied on by EPA, elevated levels of ozone produce short-term acute effects such as wheezing, shortness of breath, and decreased lung function. The severity of the effects depends upon the level and length of exposure, as well as the respiratory rates of those exposed. As the Agency points out, however, pulmonary function responses to ozone exposure tend to return to baseline levels shortly after short-term exposure. Furthermore, effects are typically attenuated (i.e., weaken) upon repeated short-term exposures over several days. For outdoor workers or highly susceptible people, EPA can only say that exposure may cause reduced productivity or reduced desire to engage in normal activities. The exposure is thought to reduce maximum sustainable levels or duration of activity. Given the lack of significant, convincing evidence of adverse health effects below current levels, EPA must retain the current standard. The EPA's own analysis indicates that there is no demonstrated relationship between short-term or prolonged exposure and long-term health effects. In fact, the studies show that effects weaken over time and that lung function decrements in exercising adults varied greatly among exposed individuals. The great variations in effects noted among exposed individuals suggest that other factors have not been considered. Primary among these is the inability to consider the effect of other pollutants or weather-related physiological stress. For example, reduced productivity or reduced desire to engage in normal activities just as equally may be caused by exposure to heat and humidity, which typically coexist with elevated ozone levels, or exposure to other pollutants. NO CAUSE-AND-EFFECT RELATIONSHIP BETWEEN SIGNIFICANT ADVERSE HEALTH EFFECTS AND EXPOSURE Without a scientific basis, EPA has made determinations regarding when certain physiological effects noted from short-term exposure become so significant that they should be regarded as adverse to human health. In a previous review by CASAC of the ozone NAAQS, it was suggested that mild responses to ozone not be considered "adverse" health effects. The CASAC said that mild physiological changes, such as those identified by the Agency as associated with ozone exposure below the current level, probably would not be considered medically significant and should not interfere with the normal activity of most people.12 Further, some studies have indicated that as much as 20 percent of the population does not experience significant lung function loss at even high ozone concentrations. Even the most sensitive 20 percent of the population does not experience statistically significant declines in lung function at the current NAAQS unless they are exercising heavily for 1 to 3 hours. EPA should not increase the stringency of the standard if no adverse health effects are observed at levels below the current standards. According to the EPA analysis, ozone exposure can cause significant adverse effects, such as increased airway responsiveness, which is an indication of a predisposition to bronchoconstriction and sensitivity to particles, antigens, and chemicals. Airway responsiveness is reportedly a concern to persons with impaired respiratory systems, such as asthmatics. The Agency admits, however, that ongoing studies must be completed and evaluated before conclusions can be drawn. EPA cannot rely on studies that do not demonstrate any health-based correlation to set a more stringent standard. Given that EPA is required to review the air quality standards every five years, and considering the significant uncertainty associated with the scientific basis for the proposal, EPA should encourage further research and take another look at the ozone NAAQS in five years. EPA's EXPOSURE ASSUMPTIONS NOT REASONABLE The studies upon which EPA relies to justify the proposed primary and secondary standards contain a significant number of flawed assumptions and methodologies. Many of these studies, some of which have not been peer-reviewed, tend to overestimate the effects of ozone exposure, underestimate background or ambient ozone levels, and exaggerate the benefit of stricter ozone standards. Many of these shortcomings were acknowledged by the CASAC and the EPA staff. One of the highly exposed groups the Agency focused on is so-called "outdoor children." The data suggest that active children exposed for 8 hours showed some of the low-level symptoms associated with ozone exposure. The Agency does not explain, however, why 8-hour daily exposure scenarios are appropriate for children in urban areas where elevated ozone levels are most prevalent. Moreover, since data suggest that symptoms from short-term and prolonged exposure are transient and attenuate over time, and since there is no correlation between prolonged exposure and chronic health effects, no evidence exists that such exposure for outdoor children has any adverse health effect. The Agency also relied upon several studies of children's summer camps to support the notion that outdoor children are among the highly exposed population. These studies, however, failed to account for the influence of other pollutants, such as pollen, weather, or other irritants. In addition, results of studies of summer camp children in New Jersey noted more severe effects than those noted in studies of California camp children even though California has significantly higher ozone concentrations. This suggests that the studies did not account for confounding factors, such as increased resistence built up by California children or the effect of other pollutants on New Jersey children. EPA has not adequately acknowledged that studies of asthmatic children in southern California do not support the studies cited for the eastern United States. One Los Angeles study concluded that time-dependent variations independent of pollution effects may be an important confounding factor and that time factors may influence lung function more than exposure to ozone. The report noted that other summer camp studies may have not accounted for acid exposure or acid-ozone interactions.13 Further, a study in the San Bernadino Mountains, where the concentrations of other pollutants are believed to be negligible, suggested that ozone levels above the current NAAQS were responsible for the loss of approximately 2.3 percent of the forced vital capacity (FVC). This level is lower than the acceptable normal level for FVC loss for within-subject variability. The study noted that this level of FVC loss, particularly since it is reversible, suggests that changes have little clinical significance.14 The Agency similarly has not acknowledged that controlled human exposure studies tend to significantly enhance total irritant symptom scores. In a paper presented to the CASAC during the 1994 review of the Ozone Criteria Document, it was shown that chamber facilities use "generated" ozone, which may enhance ozone levels and introduce other species not encountered in ambient air.15 These factors may account for higher levels of observed health effects in controlled studies. The Agency must explain how the skewed data from these studies has been accounted for before it finalizes this proposal. The Agency, while admitting that the data concerning the effects of long-term exposure are inconclusive, suggests that the results of animal studies indicate that potential long-term effects warrant an increased level of protection for short-term and prolonged exposure. The animal studies cited, which had exposure times of 78 weeks and 20 months, however, fail to take into consideration that actual elevated ozone concentrations are dependant on climate, season, and weather. Exposure scenarios such as the ones used in these studies are unrealistic because human exposure over longer periods is interrupted by different activity levels, movement, and time spent indoors, as well as by changes in seasons and weather conditions. Furthermore, even under extreme exposure scenarios, studies were inconclusive concerning genotoxicity and carcinogenicity, particularly at lower concentrations. Thus, EPA should not rely on these laboratory animal studies to justify the "margin of safety" used to support the proposed change in the ozone NAAQS because there is no demonstrated correlation between exposure and chronic effects. The research studies used to support the formula for the alternative proposed secondary standard, SUM06, also include a number of uncertainties. This shortcoming was observed in both the Staff Paper and the CASAC's closure letter. For example, the open-top chamber (OTC) apparatus used in the National Crop Loss Assessment Network (NCLAN) studies, upon which the SUM06 recommendation is based, used controls that are "cleaner" than typical background ozone levels and by their very design produce results that overestimate the effects of ozone on plant yield. In addition, exposure regimes contained peak concentrations that were atypical of ambient exposures. The extrapolation of results from controlled experiments to real-world environmental conditions, and to nationwide exposure patterns, also introduced a number of uncertainties. Furthermore, many of the studies used to justify the SUM06 secondary standard have not been peer-reviewed. Finally, there was disagreement among the CASAC's plant experts whether the SUM06 formula is the best form for a cumulative standard to protect vegetation from ozone. As three members of the CASAC stated, the risk assessments are too crude to be used as a scientific basis for a policy decision.16 REGULATORY IMPACT ISSUES By EPA's own analysis, the cost of the proposed new ozone NAAQS outweighs its benefits. The proposal, therefore, should be abandoned, unless EPA can provide further justification. The expense to both small and large companies as a result of the new ozone NAAQS might be justified if the benefits from this proposed decision were significant and if the problem to be addressed was certain and sufficiently serious. Given the uncertainty of the problem to be addressed by this regulation and, consequently, the speculative nature of any benefits to be achieved, the great expense placed on states and on industry is not justified. EPA asserts that it is prohibited by law from evaluating costs when setting NAAQS. The secondary NAAQS standard, however, requires an assessment of the impact of nonattainment on economic values, crops, and property, among other factors. Section 109(b)(2) of the Clean Air Act defines the secondary standard as one "the attainment and maintenance of which in the judgment of the Administrator, based on such criteria, is requisite to protect the public welfare from any known or anticipated adverse effects." "Welfare" includes economic values, personal comfort, property, climate, and visibility. Therefore, an analysis of the secondary standard is incomplete if it makes no trade-offs between the costs associated with nonattainment and the potential costs associated with attainment. For example, a reduction in nitrogen oxide caused by regulations adopted pursuant to a State Implementation Plan (SIP) designed to meet the secondary standard could result in reduced nitrogen content in soil, which could have a negative impact on crop yields. In this way, the economic factor that was used to justify setting the secondary standard could be overcome by the adverse economic impact of meeting the standard. This type of analysis is not the same as considering cost when deciding whether to promulgate NAAQS rules. Thus, despite EPA's assertion that it is prohibited from considering cost, failure to make this type of tradeoff when analyzing economic values undermines the economic values basis for the secondary standard. The EPA proposal conflicts with Executive Order 12866.17 For example, under the Executive Order, EPA should promulgate only such regulations as "are required by law, necessary to interpret the law, or made necessary by compelling need." This proposed decision is not required by law or needed to interpret the law. Further, the Agency has not shown a compelling need. The proposal is also inconsistent with the Executive Order's mandate of cost-effective regulation. The Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) affords small businesses needed access to the Agency's rulemaking process. Many SPI members are small businesses -- more than 80 percent of the companies in our industry have fewer than 100 employees. The average number of employees is approximately 50. They do not have environmental compliance departments. Imposing the burdens that the proposed decision is likely to bring, without first exploring the impact of this decision through a formal SBREFA review process, is unreasonable. While an agency does not have to select the regulatory alternative that is the least burdensome on small businesses, an agency must explain its decisional criteria and how it has minimized the effect of the rule upon small businesses. As SPI explained in our request for an extension of the comment period, these requirements apply to this rulemaking. We, of course, fully support EPA's decision to work with the Small Business Administration to form a regulatory review panel, but we disagree with the Agency's characterization of the panel as voluntary. We believe the panel is required by Section 244 of SBREFA. The Agency asserts that it is not required to conduct a regulatory flexibility analysis (RFA), pursuant to the Regulatory Flexibility Act (RFA) as amended by SBREFA, because the NAAQS will not be directly applicable to small entities. The Agency's position is based on the conclusion that NAAQS are only applicable to the states, which must then amend their SIPs to incorporate the new standard. This logic, however, would permit the Agency to skirt the clear intent of Congress in adopting both laws, particularly because neither law is applicable to the states when they develop their SIPs. The purpose of both RFA and SBREFA is to make federal rulemaking more accessible and accountable to small entities. By dismissing the laws' requirements as inapplicable to NAAQS, the Agency is using the regulatory framework of the Clean Air Act to circumvent Congress' intent to make the Agency more accountable. The Agency should analyze the impact of the revised NAAQS on small entities as required by both EPA should reconsider its determination that SBREFA does not apply to this proposal. A SBREFA review of this proposal is critical because the proposed tightening of the ozone standard will drive each state to further regulate emissions from sources within the state which will likely have a very significant economic impact on small entities. States with nonattainment areas will find it particularly difficult to meet the new standards without burdening small businesses with additional regulation. EPA did not provide a sufficient statement of factual basis for its certification of no significant impact for this proposal. SBREFA 243 amends 5 U.S.C. 605(b), regarding agency certification of "no significant economic impact." SBREFA requires that an agency publish its certification in the Federal Register with a statement providing the factual basis for the determination. Before this amendment, 5 U.S.C. 605(b) only required agencies to provide a "succinct statement explaining the reasons" for the certification. Thus, SBREFA requires EPA to provide a more specific justification for its certification to provide a record upon which a court may review the Agency's determination. EPA's explanation for its finding of "no significant economic impact" for the ozone NAAQS appears to be simply a "succinct statement." It does not comply with the requirement for a more detailed statement of factual basis for the Agency's determination. Furthermore, EPA's certification of no significant impact is not within the spirit of SBREFA. Section 202 of SBREFA states that the regulatory flexibility requirements "have too often been ignored" by agencies, leaving small business to bear a disproportionate share of regulatory costs and burdens. SBREFA was adopted with the purpose of holding agencies more accountable for discretionary decisions, including agency determinations of "no significant economic impact." EPA's finding ry burdens that will be imposed on small businesses as a result of states implementing this standard. EPA's attempt to circumvent the regulatory flexibility requirements is exactly the type of agency action SBREFA was intended to remedy. SPI believes that SBREFA clearly applies to this proposal and would like to participate in any SBREFA review EPA undertakes. EPA must acknowledge that its finding of "no significant impact" is subject to judicial and congressional review and that other provisions of SBREFA apply. To protect the integrity and fairness of the rulemaking process, EPA should acknowledge the applicability of SBREFA and follow its mandates. REGULATION UNNECESSARY AT THIS TIME The Agency's proposal to modify the ozone NAAQS will, if adopted, undoubtedly have broad impact on SPI members, including its small business members. SPI's members, many of whom are small business owners, are ill-equipped to the handle the ever-increasing regulatory burdens. Some of these firms may need to obtain permits for the first time and modify their operations or install control equipment to meet the new state regulations promulgated to implement the 1990 amendments to the Clean Air Act. These firms are already responding to a staggering number of new requirements that have been imposed on them since 1990 (e.g., RACT rules, Title V permitting, and federal and state air toxics programs) and trying to plan for those rules that will be imposed on them in the near term (e.g., flexible foam MACT, foam fabrication MACT, and reinforced composites MACT). EPA should fully implement the amendments before making any changes to the ozone NAAQS. A number of other Clean Air Act programs are specifically addressing the emission of ozone precursors. If this decision is finalized as proposed, states will be forced to further regulate air emissions without first realizing the reductions that will occur by implementing these programs. For example, in 1996, EPA proposed a regulation to restrict emissions of VOCs from consumer and commercial products. These product-specific regulations are projected by EPA to have a significant effect on air quality attainment as they are implemented. In addition, many states tightened VOC emissions through SIP regulations to meet the required 15-percent "Reasonable Further Progress" demonstration required by November 15, 1996. EPA should also consider the impact of its Maximum Achievable Control Technology (MACT) program. Since most hazardous air pollutants (HAPs) are also VOCs, the continuing implementation of the MACT program will have a positive effect on ozone levels. The acid rain program will similarly assist in the achievement of ozone reductions by restricting emissions of NOx. By EPA's own assessment, increased regulation is not needed at this point. In last year's National Air Quality and Emissions Trends Report, EPA claimed that emissions and ambient air concentrations of six major air pollutants have decreased by 30 percent nationally over the past 25 years. In addition, the report noted that the number of ozone nonattainment areas decreased from 98 areas in 1990 to 66 in 1995. Further, the report noted that although unusually high temperatures in 1995 contributed to increased ozone levels, the majority of monitoring sites showed a decease in concentrations of toxics and VOCs. Against this dramatic improvement over the last 10 years, the implementation of the SIP restrictions on VOCs and NOx and the acid rain program should further decrease the number of nonattainment areas. Thus, because by the Agency's own assessment air quality has improved and will continue to improve without the proposed rule, more stringent ozone standards are not necessary at this point. CONCLUSION SPI is opposed to the proposed revision to the ozone NAAQS for the following reasons: EPA's own panel of experts found no health basis for changing the current standard;
Respectfully Submitted, Maureen A. Healey Of Counsel: Jerome H. Heckman
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 © Copyright 2001 The Society of the Plastics Industry.
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