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National
Ambient Air Quality Standards COMMENTS
OF THE March 12, 1997 The
Society of the Plastics Industry, Inc COMMENTS ON THE PROPOSED NATIONAL AMBIENT AIR QUALITY STANDARDS FOR PARTICULATE MATTER 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 particulate matter.2 Many SPI members are subject to regulations imposed by states to ensure compliance with the Clean Air Act's air quality standards and, therefore, will be affected by this proposed regulation. SPI members operate facilities that may emit particulate matter or particulate matter precursors. As a result, SPI and its members have a direct and substantial interest in this rulemaking. SPI opposes the adoption of this standard because the Agency does not have sufficient data to support the standard, does not adequately consider the uncertainties in the data it does have, and makes assumptions that are not supported by the data. In addition, EPA must analyze the impact of this rule on small businesses, as it is required to do under the Small Business Regulatory Enforcement Fairness Act 3. It is extremely doubtful, assuming the true costs could be known, that future health benefits justify such a rule. COMMENTS ON THE PM2.5 STANDARD Science Does Not Support a Change in the Standard 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 such 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 available at the time of standard setting, as well as to provide a reasonable degree of protection against hazards that research has not yet identified. 4 SPI believes that EPA interprets the term adequate margin of safety too broadly. Although the courts afford the Agency some discretion in implementing its statutory mandates, it is still required to base its decisions on reasonable extrapolations from reliable data.5 In preparing this proposed decision and the Criteria Document, the Agency has made assumptions that are not reasonable based on data that are not reliable for the purpose of setting an ambient air quality standard. Indeed, although the Agency may err on the side of overprotection. . . [it] may not engage in sheer guesswork. 6 The Agency must support its conclusions with a reasoned analysis and evidence of risk contained in the record.7 Although the Criteria Document reflects an exhaustive review of the scientific literature, the conclusions that EPA draws from that literature, which are the basis for this proposal, do not reflect good science. 8 For example, the Agency's reliance on epidemiological studies, without clinical support, is not reasonable for setting an air quality standard because such studies have too many variables that are not controllable. Further, the Agency draws too many unsupported assumptions from these studies. They do not clearly point to PM2.5 as the pollutant causing the observed health effects. EPA, therefore, lacks a scientific basis for its proposed standard. The CASAC found that there appears to be no apparent threshold for biological responses to PM exposures. 9 Yet, EPA is proposing a 15 /m3 annual standard and a 50 /m3 24-hour standard to protect the public health. EPA appears to be defining the term public health for the purposes of this proposal as certain sensitive subpopulations. EPA does not have a rational basis for this definition. If there is no level below which no health effects occur, then the EPA cannot set a standard under the current statutory framework using this definition, because some segment of the population will always experience health effects. If the term public health means protecting every person from all adverse effects, the Agency moves to a zero-risk standard, which is clearly at odds with congressional direction and intent. In the Preamble, the Agency states, [t]he Act does not require the Administrator to establish a primary NAAQS at a zero-risk level, but rather at a level that reduces risk sufficiently so as to protect public health with an adequate margin of safety. 10 SPI agrees that the Act does not require a zero-risk level, but without a reasonable definition of public health and established criteria for determining an adverse health effect, EPA cannot avoid eventually setting such a level, which would be unreasonable and have unacceptable consequences. EPA Needs Additional Data to Support Change After a thorough review of the proposal and the technical and health information analyses in EPA's Criteria Document and Staff Paper, the Clean Air Act Science Advisory Committee (CASAC), in its closure letter, indicates that achieving the goal of a scientifically defensible NAAQS for PM may require iterative steps to be taken in which new data are acquired to fill obvious and critical voids in our knowledge.11 The letter also refers to the many unanswered questions and uncertainties associated with establishing causality of the association between PM2.5 and mortality. 12 CASAC recommended that EPA immediately implement a targeted research program to address these unanswered questions and uncertainties. 13 Now that EPA has complied with its statutory mandate to review the PM air quality standard, SPI believes that the Agency must embark on the research program recommended by the CASAC before it makes a final determination that a change in the standard is necessary.14 We outline a few of the significant data gaps below. EPA Lacks Monitoring Data The Agency does not know the current ambient concentration of PM2.5, also known as fine particulate, because few PM2.5 monitors are in place around the country. Most monitors currently in place are PM10 monitors. The Agency, therefore, has limited monitoring data to indicate the amount of PM2.5 in the ambient air and the degree to which the general population or susceptible populations are exposed to it. EPA is only now discussing the implementation of a monitoring system.15 EPA acknowledges in the monitoring proposal that very little PM2.5 measurement data currently exists. EPA intends these proposed air monitoring requirements to help in assessing the composition, trends, and sources of PM2.5 nationwide.16 It is not acceptable for EPA to set a standard and then determine whether a problem exists, yet the Agency is doing just that. EPA must undertake sufficient ambient monitoring to determine the current PM2.5 concentration before a standard can be set. Without adequate monitoring data, a relationship between exposure and effect cannot be demonstrated, assuming ambient monitors are an appropriate surrogate for exposure as the Agency has done. Without this relationship, a risk model cannot be developed that permits setting a rational exposure limit. Similarly, EPA lacks data on industry emissions of PM2.5. Industry has not routinely analyzed for fine particles. Thus, neither EPA nor the states, who will be required to attain this standard if adopted, can know which mobile or stationary sources to regulate. EPA Does Not Know Constituents of Concern EPA lacks information to determine the chemical composition of the particulate matter that is linked to the supposed increases in mortality and morbidity. EPA does not know whether only certain constituents of PM2.5 are responsible for the adverse health effects. The studies on which EPA relies to set the limits may contain several sources of bias, including toxic substances that affect reactions to PM. Assuming that emissions of particulate matter are causing adverse health effects, without information regarding the constituents of concern, much money may be spent on control measures that may not be effective in controlling the constituents of concern. As a result, there may be no reduction in adverse effects. EPA Lacks Data to Support PM2.5 Definition EPA does not have data that clearly support setting a new PM standard for fine particulate. The CASAC found the argument for a PM2.5 standard was not compelling. 17 As the CASAC indicated, [t]he risk factors being reported are not large and they have relatively large uncertainties. 18 EPA has simply made a policy choice in proposing this standard, without supporting data. Without information to support a point below PM10 that clearly defines a particle size with different characteristics and different health effects than PM10, SPI believes that EPA should not set a separate standard. EPA Does Not Know Biological Mechanism The studies that EPA uses to support the proposal do not provide information that relates the effects to a plausible biological mechanism. EPA does not know the biological mechanism to explain the link between PM2.5 and increases in mortality. EPA must be able to establish a plausible biological mechanism before it finalizes a PM2.5 standard. Without it, the Agency lacks support for its assumption that a cause and effect relationship between PM2.5 and adverse health effects exists. It will also have difficulty determining the constituents of concern within particulate matter. EPA Does Not Adequately Consider Uncertainty in Data Members of the CASAC were concerned with a number of aspects of the Agency's review of the data including, exposure misclassification, measurement error, the influence of confounders, the shape of the dose-response function, the use of a national PM2.5/PM10 ratio to estimate local PM2.5 concentrations, the fraction of the daily mortality that is advanced by a few days because of pollution, the lack of an understanding of toxicological mechanisms, and the existence of possible alternative explanations. 19 EPA has not adequately addressed these concerns in its Staff Paper or the Criteria Document. EPA must undertake additional research and analysis to address these concerns, a few of which we discuss in more detail below, before it determines that a revised standard is needed. Exposure Misclassification or Measurement Error The studies upon which EPA relies lack data showing the level of particulate matter to which individuals in the studies were exposed. The studies used emissions data from a single ambient monitor in each metropolitan area. A single monitor may not represent the air quality to which the subjects in the studies were actually exposed. Commenting on an earlier version of the Criteria Document, the CASAC wrote: the Agency attempts to establish a link between personal exposure (PE - the exposure one would measure with a personal PM monitor) and the exposure estimated from a fixed-site monitor located at some central monitoring (CM) site. This is a key issue because all of the epidemiological studies linking PM to mortality/morbidity use data from CM sites. In Chapter 7, fourteen studies are cited which show no relationship or a poor relationship between PE and exposures estimated from a CM for both PM10 and PM2.5. One other study shows an excellent correlation between particulate sulfate PE and outdoor concentrations which the Agency embraces. One positive result out of 15 studies is not a strong case for the relationship.20 EPA has not adequately addressed the CASAC's concern. The Criteria Document understates the Agency's inability to link personal exposures with readings from a single ambient monitor when it states, [t]here remains much uncertainty in the published data base regarding...the extent to which findings in one location can be generalized to other locations.... Criteria Document at 13-30. EPA clearly has not taken adequate steps to remedy its lack of exposure data. Many factors will affect personal exposure. Housing characteristics, physical characteristics, personal activities, and breathing rates, which vary by activity, are just a few of the factors that will affect how much an individual is exposed. A recent paper indicates, "[N]o amount of smoothing or curve fitting can alter the fact that the necessary information on actual exposures is not available. Personal exposures can be much higher than outdoor concentrations because indoor sources tend to be poorly correlated with outdoor factors. 21 EPA must further consider these concerns before it determines that this more stringent standard is necessary. Use of PM10 Information to Estimate PM2.5 Concentrations The proposed decision indicates that of the 38 daily mortality analyses listed in Table 12-2 of the Criteria Document most found statistically significant associations between PM and mortality.22 The proposed decision should make it clear that only two of those studies used PM2.5 measurements. Most [studies] used PM10 or total suspended particulates (TSP), which are only roughly correlated with PM2.5, and therefore, do not allow one to conclude that PM2.5 is the causative agent or indeed that any specific component of the PM10 is the causative agent. 23 Of the studies that looked at PM2.5, one found statistically significant increases in mortality in only three of the six cities studied and did not analyze for co-pollutants.24 If PM2.5 is so distinct as to require a separate standard, then EPA should not rely on PM10 and TSP to show that PM2.5 causes adverse health effects. It should only use PM2.5 data. Influence of ConfoundersEPA's proposed rule does not adequately account for confounding factors in the epidemiological studies. More than half of the 38 studies indicate the likelihood of confounders (most prominently SOx, then NOx, CO, O3, humidity,25 and temperature) or did not consider confounders. The Criteria Document indicates that [a] number of studies using multiple air pollutants as predictors of health effects have not completely resolved the role of PM as an independent causal factor. 26 The Criteria Document further states, [c]onfident assignment of specific fractions of variation in health endpoints to specific air pollutants may still require additional study. 27 Much of EPA's quantitative analysis on which it based its proposed rule is inappropriately based on studies that do not adequately consider these confounders. Consequently, we have a dilemma in not being able to definitively identify the possible causative agent(s), and hence, not being able to identify the air pollution component(s) that needs to be reduced in order to reduce mortality/morbidity. 28 Without substantially resolving confounding substances, neither EPA nor the public can know with an acceptable degree of certainty that fine particles are the causal factor for adverse health effects. EPA Makes Assumptions Not Supported by the Data EPA relies on epidemiological studies to infer that there is a cause and effect relationship between exposure to PM2.5 and adverse health effects. Without other evidence of a cause and effect relationship, epidemiological studies are insufficient simply because too many variables are present and are not controllable.29 The Agency lacks the biological and human clinical data needed to support this cause and effect relationship. The CASAC indicated that [o]nly an intervention study or an experimental exposure study can demonstrate cause and effect. 30 As indicated above, in some studies, other pollutants were shown to cause some of the same adverse effects that were observed in the PM studies, which calls into question the cause and effect relationship between particulate matter and the observed adverse health effects. EPA should gather evidence in support of the epidemiological studies before it finalizes this standard. EPA's recently released National Air Quality and Emission Trends Report 1995" indicates that during the period 1988-1995, emissions of PM10 decreased nationally by 17 percent. In the same period, ambient concentrations decreased by 22%. Presumably, some portion of this reduction included fine particulate. If fine particulate emissions decreased, or even remained static, they would not appear to explain the increased mortality and morbidity observed in the studies.31 Further, EPA assumes that reducing emissions of PM2.5 will result in a reduction of adverse health effects. The Air Trends report, however, indicates that only 6% of PM10 emissions are from traditionally inventoried source categories . Fugitive dust comprises nearly 68% of PM10 emissions, agriculture and forestry make up 20%, and natural sources account for nearly 7%. These types of sources either cannot be controlled or are not easily controlled. States, therefore, are likely to further control the traditionally inventoried sources. Reducing 6% of the PM emissions is not likely to have a significant impact on adverse health effects, if in fact a correlation exists between PM emissions and adverse health effects. The Agency should consider both the reductions described in the Air Trends report and future emission reductions to be achieved as a result of the acid rain program, hazardous air pollutant standards, and reductions in criteria pollutants from State Implementation Plan requirements before EPA determines whether this proposed standard is actually necessary. REGULATORY IMPACT ISSUES Executive Order 12866 We find very little evidence in this proposal that EPA considered the spirit of Executive Order 12866.32 Although EPA acknowledges the large number of limitations and uncertainties inherent in estimating these national costs and benefits, the Agency believes that industry will be able to develop cost-effective compliance strategies.33 EPA appears to have no basis for this belief and, given all of the other current regulatory programs imposing stringent emission requirements on industry, it seems unlikely that industry can cost-effectively comply with this standard. In addition, the Agency grossly understates the speculative nature of the benefits that this proposal will bring, if any. 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. In addition, the Executive Order states, In deciding whether and how to regulate, agencies should assess all costs and benefits of available regulatory alternatives, including the alternative of not regulating. 34 The Agency has not shown a compelling need for this regulation or adequately analyzed the costs and benefits of this regulation. Small Business Impacts Many SPI members are small businesses -- more than 80% of the companies in our industry have fewer than 100 employees. Companies employ on average approximately 50 people. These companies are not likely to 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 review process pursuant to the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), is unreasonable. The Agency asserts that it is not required to conduct a SBREFA review because the standard will not have a significant impact on small entities. The Agency also asserts that it is not required to perform a regulatory flexibility analysis (RFA), pursuant to the Regulatory Flexibility Act. The Agency's position is based on the conclusion that the standard is only applicable to the states, which must then amend their SIPs to incorporate it. 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 federal agencies more accountable to small entities. By dismissing the laws' requirements as inapplicable to this standard, the Agency is using the regulatory framework of the Clean Air Act to circumvent Congress' intent in adopting SBREFA. Further, 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, Sr 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 this standard 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. In addition, 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 of no significant economic impact for its proposed particulate matter NAAQS ignores the reality of the regulatory 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. 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. A SBREFA review of these proposals is critical because the proposed particulate matter 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 additioness. The Act applies to all rules, including what we typically consider rules subject to notice and comment procedures. 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 include a description of the steps it has taken to minimize the significant economic impact on small businesses. As SPI explained in our request for an extension of the comment period, these requirements apply to this rulemaking. SPI, of course, fully supports EPA's decision to work with the Small Business Administration to form a regulatory review panel, but SPI does not agree with the Agency's characterization of the panel as voluntary. SPI believes the panel is required by Section 244 of SBREFA. SPI SUPPORTS CHANGE TO PM10 STANDARD SPI supports EPA's decision to change the current PM10 standard by changing the method a state would use to demonstrate compliance with the 24-hour standard. Under the current method, an area is in violation of the 24-hour standard if it exceeds the standard more than one time per year. Under the proposal, EPA will look at the 98th percentile of the particulate matter readings, averaged over 3 years, to determine whether a state is in compliance with the air quality standard. This new method is fairer to states because it is a more robust indicator of air quality. Further, it does not penalize states for a brief spike in emissions which could be the result of weather or a single facility malfunction. It also is sufficiently protective of the environment because it ensures that the air quality will meet the standard 98% of the time. CONCLUSION EPA's decision to propose a change to the particulate matter standard without adequate scientific support is arbitrary. The decision appears to be a matter of convenience on the Agency's part in responding to litigation by the American Lung Association 35 rather than the result of necessity. EPA's decision to propose a change to the standard is also capricious because EPA has no apparent or cogent reason for the change. SPI is opposed to the proposed particulate matter standard because:
For the reasons stated above, SPI strongly urges the Agency to take the following steps before finalizing the proposed rule:
We appreciate your attention to the concerns we have expressed in these comments. Please contact me at (202) 974-5219 if you have any questions or would like to discuss these comments. Respectfully Submitted, Maureen
A. Healey Of Counsel: Jerome
H. Heckman
More Public Policy: Environment . Worker Safety . Transportation . Codes and Standards . Food, Drug,and Cosmetic Packaging . International Trade . Other Issues |
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 © Copyright 2001 The Society of the Plastics Industry.
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