Document 8601JVV2jJyqyGnkzzejpMRd

264 MULE 1 STATUS ENVIRONMENT REPORTER MttflJM. INVkSIMUtT I'HUTJIUUICI (OIIL-UM*.) COST (ml 11 COST a< 4s 11>i>I UMAUSTs T* Vtlii(ltE p>iip mob lier|u I r ytt>* *11 h*4 la* Inil6| purpose*# CPA la land* to rolai both the reporting r v<(tt I r *ofi t and the ri^uirtotilt lor quo 11 f t c* 11 oo s lor 0* ncof t<0 to radwc* 4olsUtMti*i burden*# famioft ntni int ichta for amuhttuytn to bhi the NOo m>ton nqi)lnttinl lor tight *ad h*y t fad* SPA ho* b*oo tivoitI golI Of tbo possibility of ol loU| ntnultc lurori to ottl tbo NOo standard* lot truck* "on tbo otaroge* rolb thoo requiring thot each vehicle teat o specific NOo standard. CPA bo* published o NFd for NOo overoglog U5 FJI 79312) and In tend* to proper* on overoglng schenn by Mop 1912# in conjunc tion *1 lb the NO* rw iomoblni# I greet Ion to provide sufficient leodiime for complionce with eon s > i on recu Ini 1 on* In oetting various emission stand ard*# EPa oust lobe Into account (be (ins that the Industry will neod to either develop ibe neces sary cuntrol technology or to sobn other changes In order to moot tbo standards* EFA intend* to provide ibis naCeaonry leadline# * neaaurod Iron tbe date of proMilgntlon of regain11 on* * EPA** position will bo msdo clear In future notice* and appropriate contact* ttttb tbo nnoo- NA NA NA NA EPA DRAFT STAFF PAPERS SUMMARIZING RECOMMENDED REVISIONS TO PARTICULATE NAAQS, CRITICAL ISSUES IN SULFUR DIOXIDE CRITERIA Issued June 13,1981 Summary of Staff Concluaiona and Recommendations for tha Primary Standards The major staff conclusions and recommendations made in Section VI are briefly summarized below; 1. A separate general particulate standard remains a reasonable public health policy choice. 2. Inclusion of particles deposited in the extrathoracic region in TSP misdirects control efforts towards particles of low risk to health. A new particle indicator representing total thoracic deposition (TTP) is recommended. A choice should be made with regard to the two ISO definitions (< 10 urn, < 15 urn). 3. Short-term (24-hour) statistical form and annual arithmetic means standards are recommended. 4. Based on a staff assessment of the epidemiology data, the numerical levels of the TTPstandards should be in the vicinity of the levels of the current TSP standards. Specifically, the recommended ranges are; 24-Hours Annual 150-350 Mg/m' 55-120 ug/m* To a greater or lesser extent, these ranges incorporate reasonable "margins of safety" for sensitive groups and for potential hazards not yet evaluated in quantitative studies. When selecting a level within these ranges, consideration must also be given to the particle size chosen for TTP. 5. Factors to be considered in evaluating risks in the ranges are discussed in Section VI. An additional consideration in choosing a size cut and level is the nature of potential secondary standards for visibility and/or soiling damage. The above ranges of TTP standards represent varying degrees of relaxation when compared to the current primary TSP standard. In the lowo- portions of the range, tbe major portion of the relaxation results from the more restrictive sin range. Thus, a city where exceedanceof the TSP standard was largely dominated by coarse mode dust would be less likely to violate a comparable TTP standard than would an area where exceedance of the TSP standard was dominated by fine and smaller coarse particles. In the upper portion of the above range, relaxation occurs for TTP as well as larger particles. Summery of Staff Conclusions and Recommendations lor tho Secondary standards Major staff conclusions and recommendations are made in Section VII and are summarized below: 1. Impairment of visibility over urban to multistate regions clearly affects public welfare. The staff recommends development of a fine particle secondary standard. If the standard is based on aircraft operations, a short-term (24 hours or less) fine mass standard in the range of 70 ng/m* to 220 nt/tn' is indicated. Consideration of aesthetic effects would suggest lower concentration and seasonal or annual averaging times. Linking the fine mass standard to a more direct indication of longer path visibility (observation. 6- 19-si Publish#*) by THE BUREAU OF NATIONAL AFFAIRS, INC- WASHINGTON. D.C. 20037 ucc 024871 CURRENT DEVELOPMENTS extinction) is advisable to account for uncertainties in the fine particle/humidity/visibility relationships. 2. Although effects on climate support the desirability of a fine particle standard, quantitative relationships are not well enough developed to provide the principal basis for selecting the level of the standard. 3. Consideration should be given to soiling and nuisance effects in determining whether a secondary standard for TSP or other large particle indicator is desirable to supplement whatever benefits accrue from the primary and secondary fine standards. Ancillary support for such a standard may be found in the limited data on effects of large particles on personal comfort. 4. While chemically active fine mode and hygroscopic coarse mode particles have been qualitatively associated with materials damage, the available data do not suggest major effects of particles on materials for concentrations and sizes at or below the ranges recommended for the primary health and secondary visibility standards. Therefore, a secondary standard based on materials damage is not recommended. 5. The staff concludes that a secondary particle standard is not needed to protect vegetation. 6. The acid deposition issue will not be addressed in the review of the particulate matter standards. Preliminary Staff Summary of Critical Elements in the Review of Primary S02 Standard Preparation of the staff paper for sulfur oxides is being deferred until results of ongoing controlled human exposur* studies of SO; are available. This preliminary staff assessment is based on available information and is intended to assist in the review of key studies included in the criteria document. Because the effects of sulfuric acid and other sulfates are included in the draft staff paper for particulate matter, this summary will focus on SO;. 1. Epidemiological studies suggest that SO;in combination with particulates may be associated with a number of health effects. By themselves, these studies may support continua tion of 24-hour and annual standard^) for SO;, perhaps indexed according to existing particle levels. Many of these studies are discussed in the draft staff paper for particulate matter. The staff intends to evaluate the following additional epidemiology studies in the S02 staff paper for qualitative or quantitative evidence: Aubry et al. (1979); Becklake et at. (1979); Camow et al. (1969); Cohen et al. (1972); Kerrebijn et al. (1975); and Neri et al. (1975).* 2. Animal and human studies suggest that the most common response to SO; is a relatively rapid reflex bronchoconstriction (Nadel et al.. 1965). Under resting conditions, SO; is largely removed by the moist lining of the upper respiratory tract, limiting the amount reaching the more sensitive areas 265 (Speizer and Frank, 1966). Particles may enhance effects of S02 through increased penetration of sorbed S02 or irritant reaction products (McJilton and Frank, 1976); Admur and Underhill. 1968). 3. The more important controlled human exposure studies of SO; are summarized in Table I. The staff believes these studies may suggest the need for a one hour SO; standard. In summary, the data indicate that most healthy adult subjects respond to short-term S02 exposures of 5 ppm or more. At lower levels (1-4 ppm) results are more mixed, with a number of studies reporting otherwise normal individual "hyperreactors." At l ppm, Frank et al. (1962) reported a significant increase in pulmonary flow resistance in 1 of 11 subjects during exposures lasting 15 minutes. Also at 1 ppm, Andersen et al. (1974) found a progressive decrease in forced expiratory flow (FEF25-75%) and forced expiratory volume (FEV) and an increase in nasal flow resistance in 15 adults exposed for six hours. Exercise appears to increase the response in normal subject, probably through increased dose to tracheobronchial receptors. With intermittent exericse, levels of 0.75 ppm S02 have resulted in significant decreases in several functional parameters in free-breathing health adults (Bates and Hazucha, 1973, Stacy et al., 1981). No significant symptomatic effects were reported in these studies. Asthmatic subjects appear to respond to SO; at levels an order of magnitude lower than do healthy adults. Several studies report marked changes in functional measurements after short-term (-1 hour) oral (mouthpiece) exposure at rest and during exercise at levels of 1-5 ppm with symptoms such as wheezing, shortness of breath increasing with concentra tion. A number of subjects were reportedly unable to tolerate these exposures. Symptomatic responses are reported at levels as low as 0.5 ppm for 10 minutes (Sheppard et al., 1981). Decreased functional measurements can occur for oral (mouthpiece) exposures of 0.25 to 0.5 ppm with exercise. For the two mast sensitive asthmatic subjects, increased airway resistance (without symptoms) was reported for oral breathing and exercise at levels of 0.1 ppm, comparable to the lowest pulmonary effects level for guinea pigs (0.16 ppm, Amdur and Underhill, 1970). At issue is at what levels would symptomatic and functional responses occur in asthmatics under free breathing conditions and with less steep temporal gradients in pollutant exposure. The results of ongoing controlled human studies should be of significant value in addressing these issues, ft is, therefore, advisable to defer preparation of the S02 staff paper at least until preliminary results are available. 4. As noted in the criteria document, the evidence for mutagenicity/cocarcinogenicity of S02 is equivocal Neverth eless, the available evidence for these important health endpoints must be carefully evaluated. 6-t9-ai Environment Reporter ucc 024872 266 ENVIRONMENT REPORTER Exoosur* Tibi* I. EFFECTS Of SO? ON RESPIRATORY HtCHAJIICS. STHP10HS 1 Observations References HesHhv Subjects 0.4*.75 ppa SOT. 2 hours, various routes, activity S studios - No affects on function, sywptoan 2 studios - Decreased In REFS, FVC, FEV. .. leffl 9 .7S ppa, froo breathing ulth exorcist Bates and Hatucha, 1973 Bed! at at., 1979 Bell et aT., 1977 HorvatC and foltnsbee, 1977 Jaeger et al_., 1979 Snell an? Luchtlnger, 1969 Stacy et eh, 1981 1-4 ppw SO*. 3-30 elnutOS. oitly rejtins, various routes S ppa SOg, 3-180 alnutos, tostly rtstlni, various route* Mixed results; soaa subjects tppeer nore sensitive; soao changes In function neesuroents Indicating bronchoconstrlctlon (e.g.. Increased ilrwiy resistance, decreased HEfR, HHFR; sene subjects report synptoas such S throat trrtatton; usually greatar response ulth oral breathing, curette Mist studios report changes In function MosurtMnti, bronchoconstrlctlon. Increased synptoas; throat irritation coups, drynoss Axidur e ah, 1953 Burton et^ al., 1969 Frank et aFT, 1967 Krlesman it al. 1976 Lawther et aT7, 1975 He! villa, 197b Nadel et al., 1965 Sin an?~Pattle. 19S7 Sheppard et ah, 1980 Snell endTuchsInger, 1969 Toaxino, 1961 Axidur e al.., 1953 Anderson at ah, 1974 Frank at aT., 1962 Krelsnan it ah, 1974 Lawther ct aT7, 1975 Holvllla. I5f0 Nadel et ah, 1965 ffewhouse et al,. 1970 ShenurJ oFaTT, 1980 Slu end PetlTd, 1957 Snell and luchslngnr, 1959 Torn)no, 1961 Asthnatlc Subjects .t-.S ppa SO;. 10-180 alnutos various ictlvlty levels, onl exposures 1-5 ppa SO;, 3-ISO alnutos. nos tty it rist, oral exposures 1 ppa S02 1 ng/e NaCl (0.9 a) drop1 its. M 7H, oral, rest an* exercise 1 hour Increaontal airway raslstanco In soaa subjacts at all lovtls, slight change In HMF8, resting subjacts; wheeling, shortnass of breath In soao subjects; potantlatod by exorcise Harked changes In respiratory function In Mtt subjects (airway resistance, othars). Niadiors reporting whcotlng, shortness of broath, dyspnea Increese with dose, exercise; soao require Mdtcetloe Decreased flew, other perooeters suggesting affects In centre! end sail airways; with eserctse S ef I experienced wheeling, 3 of t shortness ef breath Jaeger at ah, 1979 Sheppar?%F"ah, 1981 krltSMO ct ah, 1974 Sheppard it IT., 1980 Sheppard et aT., 1981 Koanlg et il*> ,9M EPA REPORTING, RECORDKEEPING FORMS UNDER REVIEW BY OMB (46 FR 30926, JuiM 11,1981) OFFICE OF MANAGEMENT AND BUDGET Agency Fonna Under Review Background June & 1981. When executive department* and agenda* propose public use bm, qulreuienle. the Office of Management id Budget (OMB) review* and acta on ose requirement* under the Paperwork iduction Act (44 USC. Chapter 38). spartmente and agendas use a number technique* including public hearing* consult with the public on significant nortine reauirementa before seekine OMB approval OMB in carrying out It* mponsibilttynnder the Act also considers comments on the forms and recordkeeping requirements that will affect the public. List of Forms Under Review Every Monday and Thursday OMB pubtishea a Bat of the agency form* 6-19-SI Published by THE BUREAU OF NATIONAL AFFAIRS. INC.. WASHINGTON, OC. 20037 ucc 024873