P.1 

OAR Box 1126 

Prepped by Ollie Stewart 

Document Number: 

28)11-1-150 

Docket Number: 

A-83-22 

Printed 4/18/2008 9:58:22 AM Sheet 28 of 182 
P.2 

*-. 

BSb?" " . THURSDAY, OCTOBER 5, 1978 

PART IV 

ENVIRONMENTAL 

PROTECTION 

AGENCY 

ng 

MAAH3I99? 

EPA AIR DOCKET. 

NATIONAL AMBIENT AIR 

QUALITY STANDARD 

FOR LEAD 

Final Rules and Proposed 

Rulemaking 
46246 

« 

[6560-01] 

Title 40—Protection of Environment 

CHAPTER I—ENVIRONMENTAL 

PROTECTION AGENCY 

SUBCHAPTER C—AIR PROGRAMS 

tPRL 937-51 

PART 50—NATIONAL PRIMARY ANO 

SECONOARY AMBIENT AIR QUALITY STANDARDS 

National Primary and Secondary Ambient Air Quality Standards for 

Lead 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rulemaking. 

SUMMARY: EPA is setting a national 

ambient air quality standard for lead 

at a level of 1.5 micrograms lead per 

cubic meter of air (^g Pb/ma), averaged over a calendar quarter. This 

final rulemaking follows a 1976 court 

order to list lead as a criteria pollutant 

for the development of an ambient 

standard, and the Agency's issuance of 

a proposed standard on December 14. 

1977. In response to comments received on the proposed standard, EPA 

has changed the averaging period for 

the standard from a calendar month 

to a calendar quarter, and has clarified 

the health basis used in selecting the 

standard level. 

In establishing the level of the final 

standard, EPA has determined that 

young children (age 1-5 years) should 

be regarded as a group within the general population that is particularly 

sensitive to lead exposure. The final 

standard for lead in air is based on 

preventing most children in the 

United States from exceeding a blood 

lead level of 30 micrograms lead per 

deciliter of blood (>ig Pb/dl). Blood 

lead levels above 30 'tig Pb/dl are associated with the impairment of heme 

synthesis in cells indicated by elevated 

erythrocyte protoporphyrin (EP), 

which EPA regards as adverse to the 

health of chronically exposed children. There are a number of other adverse health effects associated with 

blood lead levels above 30 ng Pb/dl, in 

children as well as In the general population, including the possibility that 

nervous system damage may occur in 

children even without overt symptoms 

of lead poisoning. 

DATES: Effective: October 5. 1978. 

After promulgation. States will have 

nine months (until July 5, 1979), to 

prepare and submit to EPA plans for 

attainment of the standard by no later 

than October of 1982. EPA's final regulations for the development of State 

RULES AND REGULATIONS 

implementation plans appear elsewhere in this FEDERAL REGISTER. 

FOR FURTHER INFORMATION 

CONTACT: 

Mr. Joseph Padgett. Director. Strategies and Air S'.andircU Division, 

Office of Air Quality Planning and 

Standards. U.S. Environmental Protection Agency, Research Triangle 

Park, N.C. 27711, telephone 919-541-

5204. 

AVAILABILITY OF RELA-TED INFORMATION 

A docket (No. OA.QP^-77-l.i rc-|---.a:aing the informat.cn used by FPA m 

the development cf the proposed 

standard is available for public inspection and copying between 3 :•• -n and 

4:30 p.m.. Monday through Triaiy. at 

EPA's Central Docket Section. Room 

2903B, Waterside Mall. 401 M Street 

SW., Washington. D C. 20450 

The Federal reference method for 

collecting and measuring lead and its 

compounds in the ambient air is published in appendix G to this promulgation. This FEDERAL REGISTER also contains proposed regulations under 40 

CFR Parts 51 and 53 for equivalent 

lead air monitoring methods, final 

rules for the development of State implementation plans promulgated 

under 40 CFR Part 51, and an advance 

notice of proposed rulemaking under 

40 CFR Part 51 for ambient monitoring in the vicinity of certain industrial 

plants .vith lead emissions. Additional 

information for the development of 

the State implementation plans is contained in the document Supplementary Guidelines for Lead Implementation Flans. The environmental and 

economic impacts of implementing 

this standard are described in an environmental impact statement and an 

economic impact assessment. These 

documents are available for public inspection and copying at the Central 

Docket Section (address above). Copies 

may be obtained upon request from 

Mr. Joseph Padgett at the above address. 

The documents Air Quality Criteria 

for Lead and Control Techniques for 

Lead Air Emissions were issued at the 

time of proposal. The Control Techniques Document is available upon request from Mr. Joseph Padgett at the 

above address. The Air Quality Criteria Document can be obtained from: 

Mr. Michael Berry, Environmental 

Criteria and Assessment Office, MD52, Office of Research and Development, U.S. Environmental Protection 

Agency, Research Triangle Park, N.C. 

27711, telephone 919-541-2266. 

SUPPLEMENTARY INFORMATION: 

BACKGROUND 

Lead is emitted to the atmosphere 

by vehicles burning leaded fuei and by 

certain stationary sources. Lead enters 

the human body through ingestion 

and inhalation with consequent absorption into the bloodstream and distribution to all body tissues. Clinical, 

epidemiological, and toxicological 

studies have demonstrated that exposure to lead adversely affects human 

health. 

EPA's initial approach to controlling 

lead in the air was to limit the lead 

emissions from automobiles, the principal source of lead air emissions. Regulations for the phasedown of lead in 

the total gasoline pool were promulgated in 1973. and, following litigation, 

modified and put into effect in 1976. 

The Agency has also established regulations requiring the availability of nolead gasoline for catalyst-equipped 

cars. EPA also intended to control 

emissions from certain categories of 

industrial point sources under section 

111 of the Clean Air Act. 

In 1975, the Natural Resources De 

fense Council (NRDC) and others 

brought suit against EPA to list lead 

under section 108 of the Clean Air Act 

as a pollutant for which air quality criteria would be developed and a national ambient air quality standard established under section 109 of the Act. 

The Court ruled in favor of NRDC. 

{NRDC. Inc. et al. v. Train, 411 F. 

Supp. 864 (S.D.N.Y.. 1976) aff'd 545 F. 

2d 320 (2d Cir. 1976).) EPA listed lead 

on March 31, 1976, and proceeded to 

develop air quality criteria and the 

proposed standard. 

On December 14, 1977, EPA proposed a standard of 1.5 fig Pb/m3

, calendar month average, proposed the 

Federal reference method for monitoring air lead levels, issued the documents Air Quality Criteria for Lead 

and Control Techniques for Lead Air 

Emissions and proposed regulations 

for State implementation plans. EPA 

invited public comments during the 

period from December 14. 1977. to 

March 17, 1978. on the standard, reference method, and the SIP regulations. 

Additional comments on the'ie matters 

were provided to EPA at a public hearing held on February 15-16. 1978. 

LEGISLATIVE REQUIREMENTS FOR NATIONAL AMBIENT AIR QUALITY STANDARDS 

Sections 108 and 109 of the Clean 

Air Act govern the development of national ambient air quality standards. 

Section 108 instructs EPA to document the scientific basis for the standard: 

Section 108'a)(2). The Administrator shall 

issue air quality criteria for an air pollutant 

within 12 months after he has included such 

pollutant in a list under paragraph (1). Air 

quality criteria for an air pollutant shall accurately reflect the latest scientific knowledge useful in indicating the kind and 

extent of all identifiable effects on public 

health or welfare which may be expected 

from the presence of such pollutant in the 

FEDERAL REGISTER, VOL. 43, NO. 194—THURSDAY, OCTOBER 5, 1978 

M 
BULKS AM® REGULATIONS. 

< ambient air. In varying quantities. The criteria for an air pollutant, to the extent practicable, shall include information on— 

(A) Those variable factors (including atmospheric conditions) which of themselves 

or in. combination with other factors may 

alter the effects on public health or welfare 

of such air pollutant; 

(B) The types of air pollutants which, 

when present ln the atmosphere, may Interact with such pollutant to produce an adverse effect on public health or welfare; and 

(C) Any known or anticipated adverse effects on welfare. 

Section 109 addresses the actual setting of the standard: 

Section 109(b)(1). National primary ambient air quality standards, prescribed under 

subsection (a) shall be ambient air quality 

standards the attainment and maintenance 

of which in the judgment of the Administrator, based on such criteria and allowing 

an adequate margin of safety, are requisite 

to protect the public health. Such primary 

standards may be revised In the same 

manner as promulgated. 

(2) Any national secondary ambient air 

quality standard prescribed, under subsection (a) shall specify a level of air quality 

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 associated with the presence of such air pollutant in the ambient 

air. Such secondary standards may be revised in the same manner as promulgated. 

In order to conform to the requirements of section 109, EPA has based 

the level of the lead air quality standard on information presented in the 

criteria document pertaining to the 

health and welfare implications of 

lead air pollution. This is in contrast 

to other sections of the Act under 

which EPA considers economic costs 

and technical availability of air pollution control systems in determining 

emissions Umitations. It is clear from 

section 109 that the Agency should 

not attempt to place the standard at a 

level estimated to be at the threshold 

for adverse health .effects, but should 

set the standard at a lower level in 

order to provide a margin of safety. 

EPA believes that the extent of the 

margin of safety represents a judgment in which the Agency considers 

the severity of reported health effects, 

the probability that such effects may 

occur, and uncertainties as to the full 

biological significance of exposure to 

lead. 

Comments resulting from external 

review of the air quality criteria and 

the proposed standard highlight disagreements on a number of areas critical to EPA's rationale for the standard. However, the scientific data base 

provided in the document Air Quality 

Criteria for Lead is as extensive as 

that for any other regulated air pollutant. Also, at every stage of development of the air quality criteria and 

the standard, EPA has facilitated and 

received broad external participation. 

EPA regards as inevitable the presence 

of scientific disagreement and uncertainty about key factors relevant to 

environmental standards. Provisions 

of the Act requiring timely promulgation of the standard, and requirements 

for periodic future review of air quality criteria and standards indicate congressional intent that the Agency proceed even where scientific knowledge 

is hot complete or full scientific consensus is absent. 

SUMMARY OF GENERAL FINDINGS FROM 

AIR QUALITY CRITERIA FOR LEAD 

Following the listing of lead as a -criteria pollutant, EPA developed the 

document. Air Quality Criteria for 

Lead. In the preparation of this document, EPA provided opportunities for 

external review and comment on three 

successive drafts. The document was 

reviewed at three meetings of the Subcommittee on Scientific Criteria for 

Environmental Lead of EPA's Science 

Advisory Board. Each of these meetings was open to the public and a 

number of individuals presented both 

critical review and new information 

for EPA's consideration. The final criteria document was issued on December 14, 1977. 

From the scientific information in 

the criteria document, EPA draws conclusions in several key areas with particular relevance for the ambient air 

quality standard for lead. 

1. There are multiple sources of lead 

exposure. In addition to air lead, these 

sources include: Lead in paint and ink, 

lead in drinking water, lead in pesticides, and lead in fresh and processed 

food. 

2. Exposure to air lead can occur directly by inhalation, or indirectly by 

ingestion of lead contaminated food, 

water, or nonfood materials including 

dust and soil. 

3. There is significant individual 

variability in response to lead exposure. Even within a particular population, individual response to lead exposure may vary widely from the average 

response for the same group. Certain 

subgroups within the general population are more susceptible to the effects of lead or have greater exposure 

potential. Of these, young children 

represent a population of foremost 

concem. 

4. Three systems within the human 

body appear to be most sensitive to 

the effects of lead—the blood-forming 

or hematopoietic system, the nervous 

system, and the renal system. In addition, lead has been shown to affect the 

normal functions of the reproductive, 

endocrine, hepatic, cardiovascular, immunologic, and gastrointestinal systems. 

5. The blood lead level thresholds 

for various biologic effects range from 

the risk of permanent, severe, neurological damage or death as blood leads 

approach and exceed 80 to 100 fig Pb/ 

dl in children down to the inhibition 

of an enzymes system as low as 10 pg 

Pb/dl. 

6. Lead is a stable compound, ubiquitously distributed, which persists and 

accumulates both in the environment 

and in the human body. In developing 

the proposed standard, EPA used 

these findings to arrive at a standard 

level of 1.5 pg Pb/ms, calendar month 

average. This level was derived from 

the Agency's judgment that the maximum safe blood lead level (geometric 

mean) for a population of young children was 15 pg Pb/dl and, of this 

amount, 12 pg Pb/dl should be attributed to nonair sources. The difference 

of 3.0 pg Pb/dl was estimated to be the 

allowable safe contribution to mean 

population blood lead from lead in the 

air. With epidemiological data indicating a general relationship of 1:2 between air lead (pg Pb/m3

) and blood 

lead (pg Pb/dl), EPA determined that 

the level for the proposed standard 

should be 1.5 pg/m'. 

SUMMARY OF ANTICIPATED IMPACTS 

While the level of the standard is 

based on health considerations, EPA 

has conducted economic and environmental studies to assess the potential 

impacts of the standard selected. EPA 

estimates that the existing regulations 

for the phase-down of lead in. gasoline, 

combined with the increasing use of 

no-lead gasoline for catalyst-equipped 

cars, will result in attainment of the 

standard in urban areas where automobile exhaust is the dominant source 

of air lead. No additional pollution 

controls are anticipated for these 

areas. 

EPA's economic analysis does indicate that there may be significant 

problems in attainment of the standard in the vicinity of nonferrous smelters and other large industrial sources 

of lead emissions. This assessment is 

based, however, on studies using general emission factors and plant configurations, combined with dispersion 

modeling. In the development of State 

plans to implement the standard. EPA 

is encouraging affected industries and 

State agencies to gather plant-specific 

technical data, ambient air quality 

data, and assessments of alternative 

engineering controls. With this information, the Agency will be able to 

more accurately evaluate tb,e impact 

of the standard and better consider 

approval of alternative approaches to 

emission control in the State plans. 

Also. EPA is encouraging affected 

firms and State agencies to evaluate in 

the early design phase, strategies 

which take into consideration the 

workplace standard for airborne lead 

which will be promulgated by the Occupational Health and Safety AdminK332QAI QB8DSTOQ, VOO. 43, COO. 194—THURSDAY, OCVOQQQ S, 197Q 

*•-•• • •** -iiiJUmn"" 
P.5 

k&rattoq, <OSHA). EPA believes that 

aate approach will facilitate application of control technologies which 

meet the requirements of both agencies. In working with OSHA to esti-

-Tnate the combined Impact of the 

OSHA and EPA standards, in coordinating compliance strategies, and in 

reviewing. State plans implementing 

the ambient standard, EPA intends to 

avoid an approach which would foster 

uncertainty in the investment decisions of affected firms. 

The Agency will make every effort 

to insure that all opportunities to 

avoid plant closures are examined, 

while at the same time assuring protection from clear risks to the public 

health. 

SUMMARY OP COMMENTS RECEIVED 

During the comment period from 

December 14, 1977, to March 17, 1978, 

and at the public meeting on February 

15-16, 1978, EPA received 95 written 

and oral comments addressing the proposed standard or the requirements 

for State implementation plans. All 

comments opposing the standard as 

excessively stringent (25) came from 

representatives of affected industries, 

and 20 of these counter-proposed 5.0 

pg Pb/m3, calendar quarter average, as 

the appropriate level for the standard. 

Comments Received Opposing the Proposed 

standard of l.S \ig/mf Calendar Month 

Average as Excessively Stringent 

Company Op- Enposed • dorsed' 

Amax Lead & Zinc, Inc X X 

American Mining Congress X X 

American Petroleum Institute X 

ASARCO X X 

Associated Octel Co., Ltd. X X 

Battery Council International X X 

Bethlehem Steel Corp X X 

Bunker Hill Co X X 

C & D Batteries Division X X 

E. I. du Pont de Nemours & Co., 

Inc X X 

ESA Laboratories. Inc X X 

Ethyl Corp X X 

General Battery Corp X X 

General Motors Corp /., 

Getty Refining 6c Marketing Co... X 

HECLA Mining Co X 

Houston Chemical X X 

Hunt OU Co X 

Kerr-McKee Corp , 

Lead Industries Association X X 

Nalco Chemical X X 

N L Industries, Inc X X 

Prestolite Battery Division X X 

Secondary Lead Smelters Association _. _ X X 

Shell OU Co X 

St. Joe Minerals Corp ••••• X X 

Texaco, Inc X X 

United Machinery Group... 

Vulcan Materials Co— _ 

' l.S iig/m'. calendar month. 

'5.0 fig/ma*, calendar quarter (or other averaging 

period). 

SUMMARY: Forty-ftve comments received trom 29 

corporations or their representatives: 25 of the 29 

firms opposed the proposed standard of 1.5 >i8/m'. 

calendar month averaae; 20 endorsed an alternative 

autus AN© ai©uy\7>ows 

standard of 5.0 tig/m1. calendar quarter average (or 

other averaging period). 

Four comments opposed the proposed standard on the grounds that it 

was not sufficiently protective of 

health. 

COMMENTS RECEIVED OPPOSING PROPOSED 

LEAD AIR QUALITY STANDARD OP 1.5 ng/m1. 

CALENDAR MONTH AVERAGE, IN FAVOR OF A 

MORE STRINGENT STANDARD 

Natural Resources Defense Council 

Dr. Sergio Piomelli, Director. Pediatric Hematology, New York University Medical 

Center Public Interest Campaign 

University of Connecticut School of Medicine 

Comments supporting the level of 

the proposed standard (17) came from 

the medical community. Federal agencies. State and local public health 

agencies, and public interest groups. 

COMMENTS RECEIVED ENDORSING PROPOSED 

LEAD AIR QUALITY STANDARD OF l.S pg/m1, 

CALENDAR MONTH AVERAGE 

STATE AND LOCAL AGENCIES 

California Department of Health 

Massachusetts Department of Public Health 

New York State Department of Environmental Conservation 

New York City Department of Environmental Protection 

Tennessee Department of Public Health 

Wisconsin Department of Natural Resources 

FEDERAL AGENCIES 

Center for Disease Control, Public Health 

Service 

Department of Transportation 

Food and Drug Administration 

Occupational Safety and Health Administration — 

PUBLIC INTEREST GROUPS AND THE MEDICAL 

COMMUNITY 

Committee on Environmental Hazards, 

American Academy of Pediatrics 

D.C. Committee for Lead Elimination in the 

District 

League of Women Voters of the United 

States 

National Urban League 

Herbert Needleman, Boston Children's Hospital Medical Center 

University of North Carolina School of 

Public Health 

In addition, EPA has received numerous comments and correspondence 

on the proposed standard after the official end of the comment period. 

Though EPA does not have a legal obligation to review these documents, it 

has, in the interest of fostering full 

public participation in the rulemaking 

process, reviewed these comments and 

correspondence as time permitted. As 

with all other documents considered 

or examined by EPA as part of its decision process, these documents have 

been placed in the public docket and 

have become part of the administrative record of this decision. 

The comments received by EPA did 

not challenge three aspects of the proposed standard: 

1. The basic structure of the rationale used by the Agency in deriving 

the level of the proposed standard. 

2. The selection of young children as 

a population particularly at risk to 

lead exposure. 

3. The attribution of 12 pg Pb/dl out 

of the target mean population blood 

lead level of 15 pg Pb/dl to nonair 

sources of lead for the purposes of setting the air standard. 

Significant comments were received, 

however, on the following key areas 

relating to the standard: 

1. The elevation of erythrocyte protoporphyrin (EP) as the first adverse 

health effect with increasing lead exposure rather than the decline of hemoglobin levels. 

2. The blood lead threshold level for 

elevated EP. 

3. The incidence of health effects in 

populations residing in the vicinity of 

industrial sources of lead particulate 

emissions. 

4. The relationship describing the response of lead in the blood to lead in 

the air. 

5. The statistical form and averaging 

period for the standard. 

6. The appropriate margin of safety. 

7. The limitation of the standard to 

the respirable fraction of total air lead 

particles. 

8. The economic impact of the standard. 

9. The State implementation plan 

regulations. 

10. The Federal reference method 

for monitoring lead air quality. 

11. The administrative procedures 

employed by EPA in the development 

of the standard and the provision for 

public participation. 

A review of the comments received 

and their disposition has been placed 

in the rulemaking docket (OAQPS-77-

1) for public inspection. The following 

paragraphs summarize the significant 

comments and present the Agency's 

findings. 

THE HEALTH SIGNIFICANCE OF ERYTHROCYTE PROTOPORPHYRIN ELEVATION 

Ten commenters disagreed with 

EPA's conclusion that the impairment 

of heme synthesis indicated by elevated erythrocyte protoporphyrin (EP) 

constituted an adverse health effect. 

Reasons for this disagreement included: 

1. An elevated level of EP is not 

itself toxic to the cells in blood or 

other tissues. 

2. EP elevation, while indicating a 

change in heme synthesis, does not indicate an insufficient production of 

heme, or hemoglobin. 

3. EP elevation and the alteration of 

heme synthesis does not imply impair-

*f 

i 

PEOEQAL REGISTER, VOL. 43, NO. 194—THURSDAY, OCTOBER S, 1970 

-' -v u 
P.6 

rs^Sj 

o t other ' mitochondrial ftme-

?JBP etevaUoB I* not associated wtth 

„„ . _ of -oUMgrahgae proteins, 

__ exposure to 

rpatttetriatirl 7__ " 

'--M-; Five commenters-dnped' wtth EPA's 

'-^aa. .%^^iMndnrtona about tt o health stgnlfit " a:

: a^'aHance of elevated I P dUng the follow-

• :"""^JA ing arguments: 

-A---J ; a • :l.The interference of lead in a fun-

~

]i X damental cellular metabolic function 

V C ato the. extent that, there is accumula-

-•>••.-.tOoii-di a substrate Is physiological im-

'•*'••-,•

 !""-» jpajtment, even without the presence 

_;..,., i. of clinical evidence of disease. 

'-." X It is prudent medical practice to 

'•.-. i. Intervene where subclinical indicators 

of physiological impairment are pres9. Tn e impairment of heme synthesis resulting from genetic or dietary 

factors places a child at enhanced risk 

to lead exposure. 

4. There Is evidence to suggest that 

•» ' impaired heme synthesis may affect 

the function of neural or hepatic 

tissue, even at levels where heme pro-

. ductlon ts sufficient for hem&topoiesis. 

• MlUtUiat HX8POH8E 

ESPA agrees with the comments received that the initial elevation of EP 

as a result of exposure to lead, while 

Indicating an impairment of heme synthesis, may not be a disease state or be 

seen as a clinically detectable decline 

in perf armance. However, the criteria 

document points out (p. 1-13) that this 

Impairment does increase progressively with lead dose. 

Th* hematological effects described above 

are the earliest physiological impairments 

encountered as a function of increasing lead 

exposures as indexed by blood lead elevations; as such,, those effects may be considered to represent critical effects of lead exposure. Although tt may be argued that certain -at the initial hematological effects 

(cadi » ALAD inhibition) constitute relatively mild, nondebtlitattng symptoms at 

low blood lead levels, they nevertheless 

signal th* onset.of steadily Intensifying adeffeets as blood lead elevations inEventually, the hematological effects teach such magnitude that they are of 

dear-cot medical significance 0 Indicators 

of undue lead eaposureia. ,; 

The fact that otl ^ conditions, such 

as htm defleiency^iBay -also Impair 

heme synthesis, does not obviate concern that lead is latafffertng with an 

essential biological function. There ls 

the possibility that a nutritional deflctoncy is aa additional stress to the 

betae^ synthetic system which may ineWftae tt o saatftfttty of a child to the 

advene eff ects of lead exposure. 

anoles-a that there is general 

that heme and heme-containtov proteins plair important roles 

in thtfoxysai*flxatfota pathways In ail 

*&m>\*toj,*6ik 

cells. WhOe the effects « f tar-lever 

lead exposure on the heme •ynOwOB 

pathway in erythrold tissue have beea 

extensively studied in part because of 

the ease wtth whkh this tissue may be 

obtained, other cellular metabolto systems uttliiiint heme are less weB understood. EPA tees not have sufficient 

information to conclude that impairment of hone synthesis in other tissues Js not of concern until blood lead 

levels are reached greater than those 

associated with hematologieal effects. 

The air quality criteria document does 

point out that this effect has been established in other tissues and that 

other dose-response factors may apply. 

The effect of lead on the formation of 

heme is not limited to the hematopoietic. 

system. Experimental animal studies have 

shown a lead effect on the heme-requblng 

protein, cytochrome P-450, an Integral put 

of the hepatic mixed-function nvirtasn 

(chapter 11). the systemic function of which 

is detoxification of exogenous substances. 

Heme synthesis inhibition also takes place 

In neural tissue. (P. 13-8.) 

In summary, the criteria document 

states: 

Elevation in protoporphyrin ls considered 

not only to be a biological Indicator of faspaired mitochondrial function of erythroid 

tissue but also an indicator of aonanaistion 

of substrate for the enzyme femcbelataae. 

It therefore has the same pathophyaioto0> 

cal meaning aa increased urinary S-ALA 

(vide supra). For these reasons, accumulation of protoporphyrin has been taken to indicate physiological impairment in.humans, 

and this clinical consensus Is expressed In 

the 1975 Statement of the Center for Disease Control (CDC), USPHS. The criterion 

used by CDC to Indicate an effect of lead en 

heme function is an FEP level of 00 pg/dl in 

the presence of a blood lead level above 80 

Ug/dl whole blood. 

More recent information relating to 

threshold of lead effects Indicates that FEP 

levels begin to increase at a blood lead value 

of 15 to 20 (ig Pb/dl blood tn children and 

women and, at a somewhat higher value, 20 

to 25 >ig Pb/dl blood, ln adult men. (P. 13-6.) 

EPA concludes that the state of elevated EP must be regarded as potentially adverse to the health of young 

children. While the onset or a mUd experience of this condition may be tolerated by an individual, as with other 

subclinical manifestations of impaired 

function, it is a prudent public health 

practice to exercise corrective action 

prior to the appearance of clinical 

symptoms. The criteria document reports that symptoms of anemia in children may occur at blood lead levels of 

40 ne/dl EPA has adopted 30 pg Pb/dl 

as a maximum safe blood lead level for 

individual children. 

THE BLOOD LXAS TJDOBHOLD N S 

BD SBTrHBOcnsnororeinnraiii 

Comments provided by ten organisations challenged EPA's oanelnsiqn 

that the threshold for the elevatoft 

EP occurs ih children at a blodd 

MIMSIU, VOC -4$, NO. 1*4 1 

a t 

w-t.i 

based o» i 

priate 

analysts wa* employed 

*. AppBcatton of a l 

technique, segmented line i 

suits in a higher threshold. 

3. Tba study m question^ 

dat* an children wtth blood 1 

in excess of 30 ji«/dl. 

-4. Other investicatocs have repotted 

higher thresholds. 

Comments in support bf the IS sc/dl 

threshold maintained: 

L liis proper to exclude valbea considered abnormal tf the intent of the 

analysis is to determine an unbiased 

" effect threshold, * ... ...... f".--

X Other studies have reported 

thresholds with error bands which tn-

-ciude 15 |ii/<0. .>•!.,' 

3. Probit analysis Is an appropriate 

technique and differs only slightly 

from the results obtained frtim segmented line analysis. 

>aZ& 

. aODHrr USFOHSB -. -a-ra... . 

' a " a •-.t^^a^TEPA a«rees lhat tto segment-^ Ififeje 

technique provides a more %ee«pb|^ 

tfmate of it o acosrelatlon r ~ ~~ 

EP elevation wtth 

lee* rtoi* Iftl^BST Pb/dl,; 

reason considered 

• ments aa to^tto nun linum aiTci 1 

lead lenmL to? a povufettkm of c m 

- Howew^i«p taw - t»r*M -•*»etirte': 

mean fbr » papulation is . ,. 

greater percentage or enHorefM 

pejiH«^^w^«tc5ed theX""" 

saft individual teviBl qf 

EPA estimates that -at a. 

geometric mean af« 16 .rt 

percent of children wiU he below 1 

Pb/dL At 157>f Pb this 

faUs to 98.T. SPA retards the nu 

of children predicted to 1 

Pb/dl as the crittjJal hearth ac«msidttatlom. For this reason. EPit baa mathtained its estimate of a- geometric 

mean of 15 «ig Pb/dl as the target fh# 

population blood lead!' A 

S3 

TBK IHUlDBMUr OF HXAI.TB DIK H QV 

POPULATIONS Exsmnra n» TB> vieinTT Or XROOStRlAJ,. SOU BUSS 

PABTICTJLATE OOSSIORS 

Several comments cited dXuaskiQS Ipwhlch proximity to dgrtfteahta """"' 

sources of afrbome 

appear to have little tar iipr;; 

Impact on resident --"—--

was takm to imply that the 

.ard was not neccisry to 

health. 

afffi. -'•'s:-1i 
P.7 

expo* 

;&£•& reason that 

the.c-snespt 

S»f the sa£e;BKjpal5> 

lead ..lasgB; ah'ojjMb fea 

-e^healfch • 

to influ 

_ :^:igjgfe«tolUadin8^C33-

f^miia'•characteristi-ca, geo-

^ont&roaological history; 

parsa^-ond.domestichygiene, the occu®34te®ic3;

r

tii9" population members, 

and '^ssjyroSd- and nonfood materials 

with.':^^^S'!--ttojf"come into contact. 

Tailing lat&!accqc&i such variability, it 

remote-the Agency's belief that airboras. 6^ ' xlirecay and indirectly contributes to the rfcik of adverse health 

conssQUtanoes -and that sufficient clinical anil epidemiological evidence is 

availaWsto form o judgment as to the 

extent of this contribution. This evidence includes epidemiological studies 

showing higher blood lead levels in 

urban areas where air lead levels were 

elevated in comparison to rural areas. 

There have also been a number of 

studies linking elevated blood lead 

levels to industrial sources of lead 

emissions. Wtth regard to the 1972 

study at El Peso, Tex., by the Center 

for Disease Control, .the criteria document reports: 

It ^JEO concluded that the primary factor 

associated with elevated blood lead levels ln 

the children was ingestion or inhalation of 

dust ctartalning lead. Data on dietary intake 

bf lentf-'-rasre. not obtained because the climate end "proximity to the smelter prevented any forming ln the erea. It was unlikely 

that the dietary lead intakes of the children 

from near the smelter and farther away 

were significantly different. (P. 12-15.) 

With regard to the report of Yankel 

et al. at Kellogg, Idaho, the criteria 

document states: 

Five factors influenced. In a statistically 

significant manner, the probability of a 

child developing an excessive blood lead 

level: .'-»•;• 

1. Concentrations of lead in ambient air 

(jig/m*- . 

2. Concentration of lead In soil (ppm). 

3. Age .(years). 

4. .Cleanliness of the home (subjective 

evaluation coded 6, l.ond 2, with 2 signifying dirtiest). — 

5. OenercJ^cOasaification. of. the parents' 

occup»UW'i#&ensiohlessX 

AlthoHjmme stxpnoest correlation.'found 

wikj'fetuam'blood lead levels and air'lead 

tesel, .&he/pothors concluded that it was unllKely tS^'tohalatiott of contaminated air 

alone coukl'eSplaln the elevated blood lead 

leveMgte;i5c^flP:i&-Kl.> • 

TUB fiK220PBSfl^ piELATIOHSHnP 

ECTWEEB LI^©'lEril5piinBLEaD m BLOOD 

Sevei ^ commutes* questioned the 

Agencies estimate that, to? children, 

om wkssMssem a£l$3d pa^ (IsjbSc meter 

cfij <^!K§gjs0 resuKSs % on ^areese of 

two micrograms lead per deciliter 

blood (f>s Pb/dl). 

AGENCY RESPONSE 

..-•fSBSfit' has reviewed the studies disused . In the criteria document which 

report changes in blood lead levels 

with different air lead levels. The 

Agency believes that one of the 

strongest epidemiological studies is 

that by Azar. et al. in which personal 

dosimeters were used to measure lead 

intake. This eliminated some of the 

uncertainty about the extent to which 

air quality observations accurately reflect actual exposure. From the Azar 

data, the relationship of lead in the air 

to lead in the blood, evaluated at 1.5 

Hg Pb/mx was 1:1.8. The Azar study 

was, however, limited to an adult population. 

A clinical study of adults. Griffin et 

al., gives roughly the same conclusion 

for a group of adults confined to a 

chamber with controlled exposure to 

lead aerosol. This study was conducted 

over a three month period with control over lead ingestion. As air lead 

levels in the chamber were increased 

from 0.15 ng Pb/m3 to 3.2 nS Pb/m', 

the air lead to blood lead relationship 

was 1:1.7. 

Because children are known to have 

greater net absorption and retention 

of lead than adults, it is reasonable to 

assume that the air lead to blood lead 

relationship for this sensitive population, exposed to air lead levels in the 

range of the proposed standard, is 

equal to if not greater than for adults. 

EPA also notes that the air lead to 

blood lead relationship is nonlinear 

and may result in a higher ratio at 

lower air levels. 

In an epidemiological study of children near a smelter, Yankel et al., the 

response of blood lead to air lead, averaged over the exposure range, was 

1.9. EPA believes that these studies as 

well as others reported in the criteria 

document, support the criteria document's conclusion that: 

Ratios between blood lead levels and air 

lead exposures were shown to range generally from 1:1 to 2:1. These were not. however, 

constant over the range or air lead concentrations encountered. There are suggestive 

data Indicating that the ratios for children 

are In the upper end of the range and may 

even be slightly above it. There is also some 

slight suggestion that the ratios for males 

are higher than those for females. (P. 12-

39.) 

THE STATISTICAL FORM AND PERIOD OP 

THE STANDARD 

One commenter expressed the view 

that, due to the lognormal distribution 

of measured air lead, a not-to-be-exceeded standard of 1.5 jig/m', calendar 

month average, would require sources 

of air lead to achieve control of their 

emissions to a geometric monthly 

mean of 0.41 jxg/m1 in order to prevent 

the occurrence of a violation. Another 

comment expressed the opinion that, 

with the normal operation of a 6-day 

sampling schedule, the number of 

samples which could be collected in 

the course of a calendar month would 

not provide a statistically valid estimate of the actual lead air quality for 

the period. 

Several comments questioned the 

health basis for the selection of the 

calendar month averaging period. 

EPA RESPONSE 

EPA accepts the consensus of comments received on the scientific and 

technical difficulties presented by the 

selection of a calendar month averaging period. The Agency believes that 

the key criterion for the averaging 

period is the protection of health of 

the sensitive population. In proposing 

the 1.5 ng/m3 standard, EPA concluded that this air level as a ceiling would 

be safe for indefinite exposure of 

young children. The critical question 

in the determination of the averaging 

period is the health significance of 

possible elevations of air lead above 

1.5 ng/m3 which could be sustained 

without violation of the average of 1.5 

^g/m3. In the proposed standard, EPA 

chose a monthly averaging period on 

the basis of a study showing an adjustment period of blood lead level with a 

change of exposure (Griffin et al.). Because of the scientific and technical 

difficulties of the monthly standard, 

EPA has reexamined this question and 

concludes that there is little reason to 

expect that the slightly greater possibUity of elevated air lead levels within 

the quarterly period is significant for 

health. This conclusion is based on the 

following points: 

(1) From actual ambient measurements, the distribution of air lead 

levels is such that where the quarterly 

standard is achieved, there is little 

possibility that there could be sustained periods greatly above the average value. 

(2) WhUe it is difficult to relate the 

extent to which a monitoring network 

actually represents the exposure situation for young chUdren, it seems likely 

that where elevated air lead, levels do 

occur, they wUI be close to point of 

mobile sources of lead air poUution. 

Typically, young chUdren will not encounter such levels for the full 24-

hour period reported by the monitor. 

(3) There Is medical evidence indicating that blood lead levels reequilibrate slowly to changes in air exposure. This serves to dampen the 

Impact of a short-term period of exposure to elevated air lead. 

(4) Direct exposure to air is only one 

of several routes of total exposure. 

This lessens the impact of a change in ' 

air lead on blood lead levels. 

7-

- * -

15V -

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c&aifla. cssasTO], VSKL OS, MO. I»4—THUQSBAV, ocroosa s, J-SFO 

'•% 

fl 

S> 

k y 
• 

-_ ©Bt-lfedoaes, 4he Aaency concludes 

toc&-.o irc&uiireBisent for the averaging 

^58. o8r--QUQl!($s? data over colsiadas' quartos1

 xsM twsw® tho veJMty- ©£' sir 

juBQlKa • .^?&$-- G3-9&P-$ without a.' dsaSfflsgsJ. ^sitesSfeasT^; the 9TOtCBtiV&-

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• • . -. -,':- .. :•••:ak,jL,• -

w^.-ftpjadSSSQED-iaQacBn oi? SAFETY 

Sevoiral omsESisnte received by the 

Agency criticized-the. proposed standard for incorporating an excessive 

Mflffsin of safety. This criticism was 

based, either on the view that the critical health eff&cfc, impaired heme synthesis, WEB not of health significance 

or s n the view that EPA had employed 

conservative estimates of the several 

factors used in calculating the standard which, when combined, resulted in 

an excessively stringent standard. 

Othes? comments were received 

t7hich! expressed concern that the 

standard had little or no margin of 

safety, particularly for certain subgroups within the general population 

of young chUdren. 

AGENCY RESPONSE 

EPA does not agree that the impairment of heme synthesis is a physiological response to lead exposure that 

Is without health significance. WhUe 

EPA does not fmd that this impairment is necessarily serious to health at 

the point at which it first can be detected by the elevation of erythrocyte 

protoporphyrin, at a threshold in a 

range of 15-20 nS Pb/dl, the Agency 

does believe, that above blood levels of 

30 ps Pb/dl this effect has progressed 

to the extent that it should be regarded as an adverse health effect. 

- In determining the final ambient air 

standard for lead, EPA has used 

margin of oafety considerations principally in establishing a maximum safe 

blood lead level for individual chUdren 

at 30 (ig Pb/dl and in determining the 

percentage of children to be placed 

below this maximum level, about 99.5 

percent Using these factors, results in 

a target geometric mean population 

blood lead of 15 ng Pb/dL 

In establishing Other factors used in 

calculating the standard, EPA has 

used margin of safety in the sense of 

making careful Judgments based on 

available data; Bui'- these Judgments 

have not been ofthe precautionary extreme of the rouge of data available to 

t he Agency. In the cos® of the geometric standard deviation (GSD), studies 

rotate d in this criteria document 

showed a range of 1.9 to 1.3. A standard tocsd 'on a-1.3 OSD would be far 

moraototagant' than using' LS. EPA 

toots t&s -1J!>.-however, because of its 

concesa . -.©soft-' <Jhe total - geometric 

otojadaffd-:di3^Soti«Ka contains variation 

QttriteatoMa .fea monitoring and analytical meStaMtotossvEia estimating th© relofctoeigl^..l^K3^;i^teaa.a- cstd blood 

lead to be 1:2, the Agency used an epidemiological study of chUdren near a 

smelter, Yankel et al., where response 

of blood lead to air lead averaged over 

the exposure range was 1 to 1.9. In 

adopting 12 ns Pb/dl as the part of 

blood lead attributable to nonair 

sources, EPA is concerned that typical 

levels for this component may be 

much greater, and that regulatory actions by other public health programs 

may be necessary to achieve a 12 jig 

level. 

Because of the variability between 

individuals in a population experiencing a given level of lead exposure, EPA 

finds it is impossible to provide the 

same amount of margin of safety for 

all members in the sensitive population, or to define the margin of safety 

in the standard as a simple percentage. EPA does believe that the factors 

it has used in designing the standard 

provide an adequate margin of safety 

for a large proportion of the sensitive 

population. The Agency does not believe that this margin is excessively 

large or on the other hand that the air 

standard can protect everyone from 

elevated blood lead levels. 

THE IMPORTANCE OF THE RESPIRABLE 

FRACTION OP TOTAL AIR LEAD LEVEL 

The Agency received a number of 

comments expressing concern that, because only a fraction of airborne particulate matter is respirable, an air 

standard based on total air lead is unnecessarily stringent. 

AGENCY RESPONSE 

EPA agrees that some lead particles 

are too small or too large to be deposited in the respiratory system. EPA 

cannot conclude, however, that particles outside of the respirable range do 

not represent an exposure hazard. A 

significant component of exposure can 

be ingestion of materials contaminated 

by deposition of lead from the air. In 

addition to the indirect route of ingestion and absorption from the gastrointestinal tract, nonresplrable lead in 

the environment may, at some point, 

become respirable through weathering 

or mechanical action. EPA concludes, 

therefore, that total airborne lead, 

both respirable and nonresplrable 

fractions, should be addressed by the 

air standard. 

THE ECONOMIC IMPACT OP THE PROPOSED 

STANDARD 

A number of commenters were critical of the Agency's economic impact 

assessment, and argued that the forecast underestimated the severity of 

the economic impact to certain lead industries. 

•u.m--

. A-8BBCT BtBEOEKTO:' ~ 

The comments csfti&r'df 

impact statement did not I 

which would aUow EPA to eos 

possibility of more severe 

impacts on certain source 

Including primary and secoE 

smelters which could have dlffleMSjT to 

limiting emissions sufficient^ to 

assure attaining the standard in their 

immediate vicinity. Under the dee m 

Air Act, the primary responsibility, for 

implementing the standard ls assigned 

to the States and each State, is required to submit a plan to EPA demonstrating how attainment is to be 

achieved. The actual economic impacts 

of implementation are difficult to estimate at this time since, following promulgation. States will have 8 months 

to develop and submit these plans to 

EPA. The plans must demonstrate attainment as soon as practicable, bet no 

later than 3 years foUowing the date 

of plan approval. However, under certain circumstances. States may re-Quest 

up to a 2-year extension of this deadline. Other sections of the CSesffl' Air 

Act may be used with the Admtoifitrator's discretion to grant furthe? este-asions of compliance deadlines teatepacted industrial facilities.,:

 i'atEPA cannot at this tima accurately 

predict the impact of th© standard, 

but with the timetable in tBe Act, cees 

no reason to expect Imminent closure 

of any facility. The Agency io c©znnaitted to developing accurate data-'foe.. 

specific plants ln cooperation with tt o 

industry and State agencies in op&ex to 

avoid the imposition of unnecessary 

controls. EPA's principal op&srn, 

however, must be to follow tho mandate of the Clean Air "Act relating to 

the protection of the public health; 

EPA believes that the economic 

impact asessment is a reasonable forecast of the economic consequences of 

implementation of the standard. 

THE PROPOSED STATE IMPLGMEOTATIOB 

PLAN (SIP) RSGULAYIOEJS 

A summary of comments and the 

Agency response is included in the 

preamble to the final regulations published elsewhere in this FEDERAL RBBISTER. . ^ . 

THE PEDERAL REVERENCE E3ETHO1&.170EI 

MONITORING LEAD ATR QUfliEnf*' . 

A summary of comments .aad t$ e 

Agency's disposition Is includeCJavth© 

preamble to the final method published elsewhere in this FBDSBAZ. ESBOISTER. . •_._ ...,z.X, •:.. • 

THE ADEHOTSTRAOTVE Pi!tCg35lkgS.f;g3° 

PLOYED BY SPA TB SHE BSVEUBPCEEa? W • 

THB PROPOSED SYAHBABB' MX>^2T23 PUOVISIOH ron-pomjc'AfisiBcSMssBq?^-' 

T w o ceaamentera sGjaiffissfca^' ®c 8 

cross exominottoss s& wi(5Krc£?*fe3 c&» 

•:¥ 

E3231AIL QEOHSTSQ, VOL 43, M®. 190—TO3J023AV, ©gmKKl S, DCSO 

yAS&a 

••y-^Ar'.-aa-^--- • 
... ,, _ ... li public hearplg^^-GJqsifflQsd and imSi^C^OOTK)' ES?A also re-

[ d-t&sasj^ta-bostt^assfi tha public 

©aifll:(^:fGJ^^^<K)aS33pEIJ§Hi|a 

artod 

juestions 

ACK£?CY BSBFOEES--" 

-Hkth the ramesfc for «*m-ese-mina-

^ and the estensta of the com.-, 

period ..were denied by the 

With rjgatrd to the request for 

the Agency deterthat, in light of the extensive 

aw already ©smducted, cross-examim was not likely to produce new 

formation oir results that would Jussuch a significant departure from 

normal rulemaking process. Also 

existence of the normal comment 

" was sufficient to allow interestmembers of the public to raise 

concerning the Agency's detions. Further, due to the expensive review opportunities avaUable 

all stages of the regulatory developtent, an extension of the comment 

riod was not believed to be suffiently necessary to further delay the 

edule for preparation of the final 

e.' 

CLARIFICATION OP Tg.KIVIHWVS OP THB 

STAHBA&D 

From reviewing the comments received, EPA wishes to clarify the following points in the presentation of 

the rationale for the final standard: 

(1) EPA ts making a distinction between the blood lead level that is the 

threshold for detection of the biological effect, impaired heme synthesis, 

and the blood lead level at which this 

effect has progressed to an extent that 

it is regarded as adverse to health. 

(2) EPA is making a distinction between estimating a m«.gimnm safe 

blood lead level for an Individual child, 

and establishing a population target 

geometric maan blood lead level for 

the sensitive population. 

(3) EPA is making a distinction between what the contribution to blood 

lead levels from nonair sources actually may be, and attributing a contribution from nonair sources for the purpose of standard setting. 

DEKTVATIOH OC THB ITUMBRXCAL LEVIS. 017 

THB PXEIAL STAHHaiaS 

SPA's objective in setting the level 

of the standard is to estimate the concentration o£ lead in the air to which 

oH groups within the general population can be exposed for protracted periods without.asa uncepeptohlip risk to 

health. , •'•,—"•,:?•. J ^JJu- " 

.This estimate".la,;^^^§/i.<HS: EPA's 

Judgment in four&eyjoi«s§V'' ..' 

(1) Determining 2he"sensitive poputoffi-an" co that group nteMa tEie geaerc3 populoitaffi: •wWfite-'llica;-tato-lowest 

D8WB--AK0 DB@ytATFl@KlS 

threshold for adverse effects or greatest potential for exposure. EPA concludes that young children, aged 1 to 

5, are the sensitive population. 

(2) Determining the safe level of 

total lead exposure for the sensitive 

population, indicated by the concentration of lead in the blood. EPA concludes that the maximum safe level of 

blood lead for an individual child is 30 

ng Pb/dl and that population blood 

lead, measured as the geometric mean, 

must be 15 nS Pb/dl in order to place 

99.5 percent of children in the United 

States below 30 fig Pb/dl. 

(3) Attributing the contribution to 

blood lead from nonair pollution 

sources. EPA concludes that 12 ^g Pb/ 

dl of population blood lead for chUdren should be atttributed to nonair 

exposure. 

(4) Determining the air lead level 

which is consistent with maintaining 

the mean population blood lead level 

at 15 jig Pb/dl. Taking into account 

exposure from other sources (12 ns 

Pb/dl) EPA has designed the standard 

to limit air contribution after achieving the standard to 3 ne Pb/dl. On the 

basis of an estimated relationship of 

air lead to blood lead of 1 to 2. EPA 

concludes that the ambient air standard should be 1.5 ns Pb/m3

. 

Each of these four areas is discussed 

further in the following sections. 

SENSITIVE POPULATION 

EPA believes that the health of 

young children is at particular risk 

from lead exposure. This is because 

children have a greater physiological 

sensitivity to the effects of lead than 

do adults and may have greater exposure to environmental lead from playing in contaminated areas. Other sensitive populations identified by EPA 

include those occupationaliy exposed, 

and pregnant women and their fetuses. Comments received on the proposed standard did not challenge 

EPA's position that young children 

are the most sensitive population for 

determining the standard. A number 

of comments did point out that within 

the general population of children 

there were subgroups with enhanced 

risk due to genetic factors, dietary deficiencies, or residence in urban areas. 

EPA acknowledges the higher risk 

status of such groups but does not 

have information either ln the air 

quality criteria or in the comments received for estimating a threshold for 

adverse effects separate from that of 

all young chUdren. Concern about 

these high risk subgroups has, however, influenced EPA's determination of 

the percentage of the population of 

children (99.5 percent) to be maintained below 30 ng Pb/dl. 

EPA continues to be concerned 

about the possible health risk of lead 

exposure for pregnant women and 

their fetuses. The stress of pregnancy 

may place pregnant women in a state 

more susceptible to the effects of lead, 

and. transplacental transfer of lead 

may affect the prenatal development 

of the chUd. There is, however, insufficient scientific information for EPA to 

either confirm or dismiss this suggestion, or to establish that pregnant 

women and fetuses are more at risk 

than young children. 

THE MAXIMUM SAFE EXPOSURE FOR 

CHILDREN 

In determining the maximum safe 

exposure to lead for children, EPA has 

taken the measurement of blood lead 

as the indicator of total lead dose. 

There are other possible indicators of 

exposure, for example the level of zinc 

protoporphyrin (ZPP), but most 

health studies reported in the criteria 

document utilize blood lead levels as 

Indications of the mobUe body burden 

of lead. The criteria document reports 

the following table of effect thresholds for children with increasing blood 

lead levels. 

SUMMARY OP LOWEST OBSERVED SWIM.' LEVELS 

IM YOUNG CHILDREN 

•*» Pb/dl 

8-ALAD Inhibition 10 

Ei-yyir-ocyte protoporphyrin elevation.... 15-20 

Increased urinary 8-ALA excretion _ 40 

Anemia 40 

Coproporphyrin elevation 40 

Cognitive (CNS) deficits 50-60 

Peripheral neuropathies SO-SO 

Encephalopathic symptoms 80-100 

(P. 13-8.) 

The first physiological effect associated with Increasing blood lead levels 

is the inhibition of the enzyme S-aminolevulinic acid dehydratase (8-ALAD), 

both in red blood cells (erythrocytes), 

and in cells in other tissues. This 

enzyme catalyzes the condensation of 

two molecules of 8-aminolevulinic acid 

(8-ALA) to fortn porphobilinogen, one 

of the components involved in the cellular synthesis of heme. The criteria 

document reports that the threshold 

for 8-ALAD inhibition in children is 10 

^g Pb/dl. 

At blood lead levels above 10 ng Pb/ 

dl, the function of 8-ALAD is increasingly inhibited by lead. The criteria 

document states that 40 *ig Pb/dl is 

the threshold for elevation of 8-ALA 

recognized as 8-ALA in the urine or 6-

ALA-U, an indication that 8-ALA has 

begun to accumulate in cells. 

EPA does not regard the Inhibition 

of 8-ALAD above 10 ^g Pb/dl as adverse to health because of the absence 

of evidence that there is an impairment of heme synthesis untU a threshold of 40 ng Pb/dl is reached. The accumulation of 8-ALA above normal 

levels, indicated by 8-ALA-U, is regarded as adverse to health, both because of impaired heme synthesis, end 

G-C333A0, OBS®!!®, V®3» 43, MO. 194—THUaSOAY, OCTOQUa 3, 1970 

Tk.'':' 

"-• ^mniiimi i i ~7TM 
.P.jO_ 

fess 

i0¥'-

l-W-afitJie EscagSEpifcy that 8-ALA accumulation is itself toalc to cells. 

The criteria document reports that 

above a threshold of 15-20 ps Pb/dl 

there ia cSjrf'^IfiVQtion of protopor-' 

phyria.. Iffl.yWjp&hrcsya-to. Protoporphyrin is oa;

';;omoaSea chemical compound used by:

 all cells in the production of- heme. In the final stage of 

heme synthesis, erythorocyte protoporphyrin (EP) and" iron are brought 

together in the ceU mitochondria. In 

the presence of lead, this step is 

blocked, possibly by inhibition of the 

enzyme ferrochelatase or by interference in the transport of iron across 

the mitochondrial membrane. Without 

incorporation into heme, the levels of 

protoporphyrin in the ceU become elevated. 

Prom review of the information provided by the air quality criteria document as well as the evidence and arguments offered by medical professionals 

commenting on the proposed standard, EPA has concluded that the effects of lead on the cellular syntheis 

of heme, as indicated by elevated 

erythrocyte protoporphyrin, are potentially adverse to the health of 

young chUdren, This appears, however, to be a question of the degree to 

which the effect has progressed. EPA 

does not believe that there is significant risk to health at the point where 

the elevation of EP can first be correlated with an increase in blood lead 

(15 to 20 jig Pb/dl). On the other 

hand, EPA regards as clearly adverse 

to health the impairment of heme 

synthesis, and other effects of lead 

which result in clinical symptoms of 

anemia above 40 pg Pb/dl. These effects are followed quickly by the risk 

of nervous system deficits for some 

children with blood lead levels of 50 pg 

Pb/dl. 

EPA has concluded that the maximum safe blood lead level for an individual child is 30 pg Pb/dl. This Is 

based on the following factors: 

(1) The maximum safe blood lead 

level should be somewhat lower than 

the threshold for a decline in hemoglobin levels (40 pg Pb/dl). 

(2) The maximum safe blood lead 

level should be at an even greater distance below the threshold for risks of 

nervous system deficits (SO pg Pb/dl). 

(3) The nwri"""" safe blood lead 

level should be no higher than the 

blood lead range characterized as 

undue exposure by the Center for Disease C-cmteoi of the PubUc Health 

Servicve s endorsed by the American 

'A-cadeing of Pediatrics, because of elevation of ejythroeyte protoporphyrin 

(above 30 pGFb/dl). 

(4) The mrv^fawum safe blood lead 

level for an .individual need not be es 

ZMm AM©'' QCKS^TOMS 

low as the detection point for the initial elevation of EP (15-20 pg Pb/dl). 

The criteria document points out 

that data from epidemiological studies 

show that the log values of measured 

individual blood lead values in a uniformly exposed, population are normally distributed with a geometric 

standard deviation (GSD) of 1.3 to 1.5. 

Using standard statistical techniques, 

it is possible to use the geometric 

standard deviation to calculate the 

mean population blood lead level 

which would place a given percentage 

of the population below the level of an 

effects threshold. A GSD of 1.5 would 

result in a lower geometric mean, and 

a more stringent standard. However, 

because some of the variabUity in the 

GSD is from measurement systems, 

EPA has used a GSD of 1.3. 

Recently, analysis of the data collected by New York City's Bureau of 

Lead Poisoning has shown that populations of children in the New York 

area consistently have distributions of 

blood lead values with a GSD of 1.4 to 

1.5. With a geometric mean of 15.0 pg 

Pb/dl, a GSD of 1.4 results in about 

two percent of the population over 

levels of 30 pg Pb/dl. A GSD of 1.5 

would place more than four percent 

over 30 pg Pb/dl. EPA is concerned 

that such results may imply that the 

standard is not as precautionary as lt 

would be if the actual GSD was 1.3. 

However, the Agency's best estimate is 

that some of the GSD is from analytical and monitoring variance, and for 

this reason, EPA is using the 1.3 value 

in calculating the final standard. 

In EPA's view, use of the 99.5 percent range Is not excessive. Prom 1970 

statistics, there are approximately 20 

mUlion children in the United States 

below the age of 5 years, 12 million in 

urban areas, and 5 million in center 

cities where lead exposure may be 

high. Again, knowledge that there are 

special high risk groups of children 

within the general population deters 

EPA from considering lower percentages. 

CONTRIBUTION TO TOTAL LEAD 

EXPOSURE FROM NONAIR SOURCES 

In the proposed standard, EPA 

argued that the air standard should 

take into account the contribution to 

blood lead levels from lead sources unrelated to air poUution. No comments 

were received chaUenging this argument. EPA continues to base its calculation of the ambient air standard on 

the assumptions that, to an extent, 

the lead contribution to blood lead 

from nonair sources should be subtracted from the estimate of safe 

mean population blood lead. Without 

this subtraction, the combined exposure to lead from air and nonair 

sources would result in a bles&J 

concentration exceeding the cal p 

EPA notes that the level «&3 

standard is strongly influenced 

Judgments about nonair contr 

to total exposure, and that thercE* 

difficulties in attempting to 

exposure from various lead 

Studies reviewed in the criteria dose-' 

ment do not provide detaUed or wid&» > 

spread information about the relative 

contribution of various sources to children's blood lead levels. Estimates cam, 

only be made by inference from othe? 

empirical or theoretical studies, usucfe 

ly involving adults. Also, it can bees- ' 

pected that the contribution to blood 

lead levels from nonair sources cass 

very widely, is probably not In cos? 

stant proportion to air lead contritetion, and in some cases may alonfi 

exceed the target mean population 

blood lead leveL -••••-

In spite of these difficulties, BS-'A 

has attempted to assess available in> 

formation in order to estimate the. 

general contribution to population, 

blood lead levels from air and nonair 

sources. This has been done with < 

uation of evidence from general • 

miological studies, studies shov 

cline of blood lead levels with < 

in air lead;' studies of blood lead levep"' 

in areas with low air lead levels, oawfr 

isotopic tracing studies. A 

Studies reviewed by the criteria •&&&•-* 

ument show that the geometete muscaT 

blood lead levels for populatteb •«£?•' 

children are frequently above Efi^jsscF 

Pb/dL In studies reported. th# rt2£35SN. 

of mean population blood lea^^eO -

for chU-dren was from 18.5 pg Pfo/SSfefe© "a 

48.4 pg Pb/dl with most studies sheer?;? 

ing mean levels greater than 23 pg D^/^a 

dl (Fine, 1972; landrigan, 187SS»WKS>. 

Lindern. 1S75). EPA beUeves thaC&te 

many of these populations, this .coialjglv 

button to blood lead levels from hdjaat?'" 

sources may exceed the desired target 

mean blood lead level. ;;T 

In a number of studies, reduction- mT 

air lead levels resulted In a decline to 

children's blood lead levels. A study of 

blood lead levels in chUdren. tn HCT? 

York City showed that" childinmV 

mean blood lead levels declined fossa 

30.5 pg Pb/dl from 1970 to 1978, whEs 

during the same period air lead leve&: 

at a single monitoring site feU from 8.0-

pg Pb/dl to 0.9 pg/Pb (BiUlcb,-lmfc'r 

Studies at Omaha, Nebr. (Angl&, WfiW 

and KeUogg, Idaho (Yankel, vc&-Ltodern, 1977) also show a drop inrms&c0':-

blood lead levels with declines, te'dfi^ 

lead levels. As air lead levels 

there appears to be a rough 

the drop in blood lead levels. 

EPA has also examined epl< 

icai studies ln the criteria 

where air lead exposure ls v 

can be assumed to be a'salman 

utor to blood lead. These 

vide an indication of bl«©-S4<a3 

resulting from a atuatitfia* 

nonair sources of l@tBi"03Q$% " 

nant. •• ' • - •a'.'^.-gra 

PUSGOAl QB0JSTEQ, V@a» 4$ CO®. IW-TO8J08BAV, -8CT5X3SQ S, tC^O1 

&*£'• ;' ' 

-vZJf i 
Rr? ••!*.. . ByiUiS AD ® QtKSQIMLATOOiKIS 

'••^rsz—j REToarruo BLOOD LOAD LBVBLS IH CHILDREN EXPOSED TO MODERATE TO Low Am LOAD 

-•iTsi-aaA' „ LSVDLS 

•:&X:' 

Inveotlcntor ..Blood Air lead0 Comment 

Hammer. 197a: 

Anaie. 1B74. 

Oot&mtth. 1974.... 

Johnson. Tillery, 1975. 

11.8 

14.4 

13.7 

10.2 

0.1.....v _,_... Children In Helena, Mont. 

0.14 Suburban ChUdren ages 1 to 4 In 

Omaha. Nebr. 

0.2 to 0.7....„ Children ln Beneda, Calif. 

0.3 to 0.6 

ChUdren In 

Crocket. Calif.. 

0.8 Female children—mean age 9 in 

Lancaster. Calif. 

' In micrograms of lead per deciliter. 

•In micrograms of lead per cubic meter. 

The range of mean blood lead levels in 

those studies ls from 10.2 pg Pb/dl to 

14.4 pg Pb/dl. with an average at 12.7 

pg Pb/dl. 

In addition to epidemiological investigations, EPA has reviewed studies 

that examine the source of blood lead 

by detecting characteristic lead isotopes. A study using isotopic tracing 

(Manton, 1977) suggests that for several adults ln Houston, Tex., 7 to 41 percent of blood lead could be attributed 

to air lead sources. An earlier isotopic 

study (Rabinowitz, 1974) concluded 

that for two adult male subjects studled, approximately one-third of total 

daUy intake of lead could be attributed to exposure to air lead levels of 1-2 

pg Pb/ms. While these results cannot 

be directly related to chUdren. it is 

reasonable to assume that children 

may exhibit the. same or higher percentages of air lead contribution to 

blood lead level because of a greater 

potential for exposure to indirect air 

sources, soU and dust. 

Prdm reviewing these areas of evidence, EPA concludes that: 

1. In studies showing mean blood 

lead levels above 15 pg Pb/dl, it is 

probable that both air and nonair 

sources of lead contribute significantly 

to blood lead with the possibUity that 

contributions from nonair sources 

exceed 15 pg Pb/dl. 

2. Studies showing'a-sustained drop 

in air lead levels show a corresponding 

drop in blood lead levels, down to an 

apparent limit in the range of 10.2 to 

14.4 pg Pb/dl. 

3. Isotopic tracing studies show air 

contribution to blood lead to be 7-41 

percent in one study and about 33 percent in another study. 

In considering this evidence, EPA 

notes that if, from the isotopic studies, 

approximately two-thirds of blood 

lead is typically derived from nonair 

sources, a mean blood lead target of 15 

pg Fb/dL would attribute 10 pg Pb/dl 

to non-air sources. On the other hand, 

the average blood lead level from the 

limited studies available where air exposure was low is 12.7 pg Pb/dl. In the 

absence of more precise Information, 

EPA is calculating the lead standard 

based on the attribution of 12 pg Pb/ 

dl of the blood lead level in children to 

lead sources unaffected by the lead air 

quality standard. EPA is aware that 

actual population blood lead levels, 

either individually or as a population 

mean, may exceed this benchmark. 

However, if EPA were to use a larger 

estimate of non-air contribution to 

blood lead, the result would be an exceptionally stringent standard, which 

would not address the principal source 

of lead exposure. 

THE RELATIONSHIP BETWEEN AIR LEAD 

EXPOSURE AND RESULTING BLOOD 

LEAD LEVEL 

EPA has reviewed the studies discussed in the criteria document which 

report changes in blood lead levels 

with different air lead levels. The 

Agency believes that one of the 

strongest epidemiological studies is 

that by Azar et al., which used personal dosimeters to measure lead intake. 

This eliminated some of the uncertainty about the extent to which air quality observations accurately reflect 

actual exposure. Prom the Azar data, 

the relationship of lead in the air to 

lead in the blood, evaluated at 1.5 pg 

Pb/m1. was 1:1.8. The Azar study was, 

however, limited to an adult population. 

A clinical study of adults. Griffin et 

al., gives roughly the same conclusion 

for a group of adults confined to a 

chamber with controUed exposure to 

lead aerosol. This study was conducted 

over a three month period with control over lead ingestion. As air lead 

levels in the chamber were increased 

from 0.15 pg Pb/m» to 3.2 pg Pb/m». 

the air lead to blood lead relationship 

was 1:1.7. 

Because chUdren are known to have 

greater net absorption and retention 

of lead than adults, it is reasonable to 

assume that the air lead to blood lead 

relationship for this sensitive population, exposed to air lead levels in the 

range of the proposed standard, is 

equal to if not greater than for adults. 

EPA also notes that the air lead to 

blood lead relationship is nonlinear 

which will result in a higher ratio at 

lower air levels. 

In an epidemiological study of chUdren near a smelter, Yankel et al., the 

response of blood lead to air lead, averaged over the exposure range, was 

1.95. This study provided information 

on the relationship of blood lead to air 

lead over a very large range of air lead 

values. The air lead values in the 

study are the result of a model calibrated by monitoring data. The relative error of the individual values, especially in the low range is larger than 

in the Azar study. 

The authors of the study, Yankel 

and von Lindern, chose a log-linear 

model which provided a good fit to the 

data and gave an estimated slope of 

about 1.2 at an air lead of 1.5. However. EPA sees a problem with a loglinear model in that it forces a lower 

slope at low air lead values and a 

higher slope at higher lead values. 

This is in direct contradiction to the 

Azar and the Griffin studies, both of 

which indicate higher slopes at lower 

air lead values. 

Because of the uncertainties in the 

low air lead values in the Idaho study, 

EPA felt that the calculation of an 

average slope or ratio over the entire 

range of data would be a moderate 

compromise. The calculation of an 

average slope gives a value of 1.95. 

EPA beUeves that these studies as weU 

as others reported in the criteria document support the document's conclusion that: 

ratios between blood lead levels and air lead 

exposures were shown to range generally 

from 1:1 to 2:1. These were not, however, 

constant over the range of air lead concentrations encountered. There are suggestive 

data indicating that the ratios for children 

are in the upper end of the range and may 

even be slightly above it. There is also some 

slight suggestion that the ratios for males 

are higher than those for females, (pp. 12-

38.) 

CALCULATION OP THE AIR STANDARD 

EPA has calculated the standard 

based on the conclusions reached in 

the previous sections; 

1. Sensitive population: Children, ages 1-5. 

2. Health basis: Maximum safe blood lead 

level for individual chUdren Is 30 pg Pb/dl 

based on concern for Impaired heme synthesis above 30 pg Pb/dl and margin of safety 

for anemia above 40 pg Pb/dl and nervous 

system deficits above 50 pg Pb/dl. 

3. Maximum safe geometric mean blood 

lead for children based on placing 99.5 percent of the sensitive population below the 

30 fig Pb/dl level of concern: 15 ns Pb/dL 

4. Estimate of blood lead level attributed 

to non-air sources: 12 us Pb/dL 

5. Allowable contribution to blood lead 

from air sources after achieving the standard: 15 ng Pb/dl-12 ns Fb/dl=8 ps Pb/dl. 

6. Air lead concentration consistent tstth 

blood lead contribution from air sources: 3 

pg Pb/dlxl ns Pb/m" air/2 pc Ffe/dS 

bloods 1.5 pg Pb/m*. vPSKJQAIS. Q56J2TG0, VOS. 43, MO. 1®4—THUQSBAV. e€f©S3Q 3, iWO 
P.12 

SELECTIOU OP THB AVERAGIHG PERIOD 

POR THB STANDARD 

Based on comments received and 

consideration by the Agency, the proposed averaging period of a calendar 

month is extended to o calendar quarter. EPA beUeves that this change wiU 

significantly improve the vaUdity of 

lead air quaUty data which wUI be 

gathered to monitor progress toward 

attainment without placing an undue 

burden of State and local environmental agencies, or significantly reducing 

the protectiveness of the standard. 

The Agency believes that the key 

criteria for the averaging period is the 

protection of the health of the sensitive population. In proposing the 1.5 

pg Pb/m' standard, EPA concluded 

that this air level was safe for young 

chUdren with an indefinie exposure 

period. The critical factor in the determination of the averaging period is 

the health significance of possible elevations of air lead above 1.5 pg Pb/m3 

which could be encountered for short 

periods without causing average levels 

to exceed the standard. In the proposed standard, EPA chose a calendar 

month averaging period on the basis 

of a study (Griffin et aL) showing an 

adjustment period of blood lead level 

with a change in exposure. Because of 

the scientific and technical difficulties 

of the monthly standard, EPA has 

reexamined this question and concluded that there is Uttle reason to expect 

that the slightly greater-possibility of 

elevated air lead levels sustainable by 

the calendar quarter standard is significant for health. This conclusion is 

based on the foUowing factors: 

(1) From actual ambient measurements, there is evidence that the distribution of air lead levels is such that 

if the quarterly average was achieved 

there is Uttle possibUity that there 

could be sustained periods greatly 

above the average value. 

(2) WhUe it is difficult to relate the 

extent to which a monitoring network 

actually represents the exposure situation for young chUdren, it seems Ukely 

that where elevated air lead levels do 

occur, they wUI be close to point or 

mobUe sources. TypicaUy, young chUdren wiU not encounter such levels for 

the fuU 24-hour period reported by 

the monitor. 

(3) There is medical evidence indicating that blood lead levels reequHibrate slowly to changes in air exposure. This serves to dampen the 

impact of a short-term period of exposure to elevated air lead. 

(4) Direct exposure to air is only one 

of several routes of total exposure. 

This lessens the impact of a change in 

air lead on blood lead levels. 

On balance, the' Agency concludes 

that a requirement for the averaging 

of air quaUty data over a calendar 

quarter wUI improve the vaUdity of air 

BWH§ AK3® B!l@(!iHLAW§«3§ 

quaUty data gathered without a significant reduction in the protectiveness of the standard. 

MAROIH OP SAFETY 

The Clean Air Act instructs EPA to 

set the level of an ambient air quaUty 

standard at a level which protects the 

pubUc health with a margin of safety. 

One approach to using margin of 

safety is to estimate the air concentration of a poUutant that is the threshold for the first adverse effect detected with increasing air levels, and then 

set the air standard at a somewhat 

lower level. The extent of the safety 

margin between the standard and the 

estimated threshold for adverse effects is influenced by such factors as 

the severity or IrreversibUity of effects, the degree of uncertainty about 

known or suspected health effects, the 

size of the population at risk, and possible interactions of several poUutants 

in potentiating health effects. WhUe 

the margin of safety is based on avaUable scientific information, this factor 

is judgmental in that the Administrator must weigh the acceptability of estimated risk. 

Estimating an appropriate margin of 

safety for the air lead standard in 

complicated by the multiple sources 

and media for lead exposure. Because 

of this, EPA has elected to use margin 

of safety considerations in estimating 

the maximum safe level for blood lead, 

and the percentage of the sensitive 

population to be placed below this 

level, rather than making a final adjustment to concentration of lead in 

the air. EPA has adopted 30 pg Pb/dl 

as the maximum safe blood lead level 

for individual chUdren, and the air 

standard is calculated to maintain 

most chUdren below this target. On 

the basis of information developed in 

the criteria document and from pubUc 

comment, blood lead levels between 30 

and 40 pg Pb/dl are associated with 

impairments of the heme synthetic 

pathway which EPA regards as adverse to health. Blood lead levels 

above 40 pg Pb/dl are associated with 

a decline in hemoglobin levels, and 

levels above 50 pg Pb/dl are associated 

with the risk of nervous system deficits for some chUdren. With a geometric mean population blood of 15 pg 

Pb/dl lead, most children will be weU 

below these thresholds, but a small 

percentage can be expected to have 

blood lead levels of concern. 

Because of the variabUity between 

individuals in a population experiencing a given level of lead exposure, EPA 

finds that lt is not possible to provide 

the same amount of margin of safety 

for aU members in the sensitive population, or to define a margin of safety 

in this standard as a simple percentage. In developing the numerical level 

of the standard, EPA used evidence in 

the criteria document that tlss htefl 

lead levels for individuals in a giwai 

population of children aire los-nomolly distributed. The statistical properties of this distribution make it possible to calculate the percentage of the 

population which wUI faU below any 

given blood lead leveL Individuals at 

each of these levels would have a different margin of safety below the 

maximum safe blood lead leveL As a 

rough example, with a population of 

chUdren with a geometric mean blood 

lead of 15 pg Pb/dl, 86 percent of the 

chUdren would be below 20 pg Pb/dL 

97.5 percent would be below 25 pg Pb/ 

dl and 99.5 percent would be below 30 

pg Pb/dl. Assuming a population of 

chUdren in central urban areas where 

air lead was at the standard leveL 

693,000 chUdren would be over 20 pg 

Pb/dl. 126,500 over 25 pg Pb/dL and 

20,605 above 30 pg Pb/dl. 

In determining the appropriate 

margin of safety, the Agency has also 

included consideration of the following factors: 

(1) In addition to the health effects 

discussed, the "Air QuaUty Criteria fo? 

Lead" report multiple biological involvements of lead in practically cffl 

ceU types, tissues, arid organ systems. 

The significance for health of these 

has not been fully studied. 

(2) There are no beneficial effects of 

lead at current environmental levels. 

(3) EPA has incomplete data about 

the extent to which chUdren are Indirectly exposed to lead from air lead 

which moves to other environmental 

media, such as water, soU and dirt, and 

food. 

(4) Lead ls chemically persistent and 

With continued uncontroUed emissions 

wUI continue to accumulate both in 

human tissue and in the environment. 

(5) There is a possibUity that lead 

exposure resulting in blood lead levels 

previously considered safe may in fact 

influence the neurological development and learning abUitles of the 

young chUd. EPA does not have evidence, however, that provides more 

than a suggestion that this could 

occur at blood lead levels below 30 Pb/ 

dl for individual chUdren. 

IMPACT OP LEAD DU STP ALL OEI BLOOD LEAD 

In the preamble for the proposed air 

standard for lead, EPA pointed out 

that the significance of dust and soil 

lead as Indirect routes of exposure haa 

been of particular concern in the case 

of young chUdren. Play habits and 

mouthing behavior between the ages 

of 1 and 5 have led to the conclusion 

that greater potential may exist in 

these chUdren for ingestion and inhalation of the lead available in contaminated dust and soU. EPA is also concerned that the deposition of lead particles can lead to general esaitomination of the environment cad to-creased 

P3E30A!, QB0JSTSa, VOL 43, (OO. 194—TMUQSOAV, <8€?@CGQ S, 1970 

UL 
WMJB AK P Ri©yiLA7ii@Cvi§ 

rfrom surface waters and 

^.^t«£Sic3.;P8vie«ed in the criteria document Indicate a correlation between 

coil cad dust levels and chUdrens' 

blood lead levels ln highly contaminated environments (Yankel and von Lindern, 1977; Barltrop, 1974; Galke, ln 

press). The lead threshold for concern 

has been reported as 1.000 parts per 

miUion (ppm) in soil (Yankel and vein 

Lindern, 1977). At levels of between 

500 and 1,000 ppm in soU, the criteria 

document concludes that blood lead 

levels begin to increase. A twofold increase ln soU concentration ln this 

range is predicted to result in a 3-6 

percent rise in blood lead levels. Below 

500 ppm lead in soil, no correlation 

has been observed with blood lead 

levels. 

The normal background for lead in 

soU is cited ln the criteria document as 

15 ppm. Due to human activities, the 

average levels in most areas of the 

United States are considerably higher. 

Soil studies conducted by EPA's Office 

of Pesticides Programs from 1974 to 

1976 in 17 urban areas reported only 3 

cities with arithmetic mean concentrations in excess of 200 ppm, with the 

highest value 537 ppm. Concentrations 

in the soils surrounding large point 

sources of lead emissions, or heavily 

travelled roads may reach many thousand .ppm. 

Because of the many factors involved, EPA is unable to predict the 

relationship between air lead levels, 

dustfall rates, and resulting soil accumulation. Complicating factors include: Particle size distribution, rainout, other meteorological factors, topographical features affecting deposition, and removal mechanisms. 

EPA believes, however, that significant impacts on blood lead of soU and 

dust lead are mainly limited to areas 

of high soU concentration (in excess of 

1,000 ppm) around large point sources 

and heavily traveUed roads. Evidence 

suggests that soU lead levels in areas 

with air lead levels in the range of the 

standard are below the threshold for 

lead health impact (Johnson, Tillery, 

1975; Johanson, 1972; EPA, 1975 Air 

Quality Data and SoU Levels). 

Comments received on the proposed 

standard argued that the lead air 

standard should be Umited to respirable size lead particulate matter, as 

larger particles would faU to the 

ground without being deposited or absorbed in the lung. EPA has decided 

not to accept this recommendation because, as discussed above, larger particles can contribute to lead dose by 

human ingestion of airborne particles, 

by contamination of other environmental media, or by eventual reduction to respirable size by mechanical 

action or weathering. 

WELFARE EFFECTS 

Comments received on the proposed 

lead air quality standard did not address the issue of welfare effects or 

the need for a secondary air quality 

standard more restrictive than the primary standard. EPA maintains its position that the primary air quality 

standard will adequately protect 

against known and anticipated adverse 

effects on public welfare. EPA does 

not have evidence that a more restrictive secondary standard would be justified. 

AvaUable evidence cited in the criteria document indicates that animals 

do not appear to be more susceptible 

to adverse effects from lead than man, 

nor do adverse effects in animals occur 

at lower levels of exposure than comparable effects in humans. 

Lead is absorbed but not accumulated to any great extent by plants from 

soU. Lead is either unavailable to 

plants or is fixed in the roots and only 

smaU amounts are transported to the 

above ground portions. Lead may be 

deposited on the leaves of plants and 

present a hazard to grazing animals. 

Although some plants may be susceptible to lead in the natural environment, it is generally in a form that is 

largely nonavailable to them. 

There is no evidence to indicate that 

ambient levels of lead result in significant damage to manmade materials. 

Effects of lead on visibility and climate are minimal. 

Based on such data, EPA promulgates the secondary air quality standard for lead at 1.5 pg Pb/m3

, calendar 

quarter average. 

ECONOMIC IMPACT ASSESSMENT 

As required by Executive Orders 

11821 and 12044. EPA has conducted a 

general analysis of the economic 

impact which might result from the 

implementation of the lead regulations. This analysis was not intended 

for nor was it used in the development 

or promulgation of the standard, and 

was issued for informational purposes 

only. 

The economic impact assessment 

points out that the categories of 

sources likely to be affected by control 

of lead emissions are primary lead and 

copper smelters, secondary lead smelters, gray iron foundries, gasoline lead 

additive manufacturers, and lead storage battery manufacturers. This analysis further indicates that some primary and secondary lead smelters and 

copper smelters may be severly 

strained economically in achieving 

emission reductions that may be required in implementing the proposed 

air quality standard. 

There are, however, uncertainties associated with evaluating the impact of 

attaining the standard. Por smelters 

and foundries, attaining the standard 

may require control of fugitive lead 

emissions, i.e., those emissions escaping from individual process operations, 

other than emissions from smoke 

stacks. Fugitive emissions are difficult 

to estimate, measure, and control; and 

it is also difficult to predict their 

Impact on air quality near the facUity. 

From the information available to 

EPA, nonferrous smelters may have 

great difficulty in achieving lead air 

quality levels consistent with the proposed standard in areas immediately 

adjacent to the smelter complex. 

The change in averaging time from a 

monthly average to a calendar quarter 

average wUI affect the economic impacts associated with the lead standard because for a given level of the 

standard, a longer averaging period is 

theoretically less stringent than a 

shorter averaging period. 

OTHER LEAD REGULATORY AND CONTROL 

PROGRAMS 

EPA's ambient air quality standard 

is only one of a number of Federal, 

State, and local programs designed to 

limit exposure to lead. 

In 1975, EPA promulgated the national Interim primary drinking water 

regulation, setting a maximum contaminant level for lead. The standard, 

aimed at protecting children from 

undue lead exposure, was set at 50 pg 

Pb/liter. In 1977, the National Academy of Sciences concluded that a lead 

level at which adverse health effects 

are observed cannot be set with assurance at any value greater than 25 pg 

Pb/liter. The Office of Drinking 

Water is currently considering the 

need to revise the interim drinking 

water standard for lead. 

Based on its toxicity, EPA has included lead on its list of priority water 

pollutants for which effluent guidelines are being developed under the 

Clean Water Act. Effluent guidelines 

are being developed for lead for nonferrous smelters, based on achievement of best available technology. 

EPA's Office of Pesticide Programs 

has promulgated regulations based on 

the toxicity of lead which require the 

addition of coloring agents to the pesticide lead arsenate and specify disposal procedures for lead pesticides. Use 

of lead in pesticides is a small and decreasing proportion of total lead consumption in the United States. 

The Resource Conservation and Recovery Act (RCRA) of 1976, through , 

which EPA is to establish standards 

on how to treat, dispose, or store hazardous wastes, provides a means for 

specifying how used crankcase oU and 

other waste streams containing lead 

should be recycled or safely disposed 

of. Regulatory actions related to 

wastes containing lead are currently 

being developed under subtitle C of 

RCRA. o 

t 

FU^GQAt QG©tSYEQ, VOI. 43, NO. 194—THURSDAY, OCTOBER 3, 1978 
—£J4. 

EPA has regulations for reducing 

the average lead content in the total 

gasoline pool to 0.9 grassa/saHo© by 

October 1, 1879, ond regulofctaaa m®-

vidimg fo? leed-free gasolto® fsg-sifred 

for cars equipped with eate3y8&2 -saavoters and other vehiclss cegteffis® fo? 

use of unleaded fuel. The fossae? ffffigtalations are based on reducing esp-sours 

to airborne lead to protect puhfe 

health. Other EPA actions which 

result in the reduction of airborne 

lead levels include ambient standards 

and State implementation plans for 

other poUutants such as particulate 

matter and sulfur dioslds end new 

source'performance standards limiting 

emissions of such poUutants. Existing 

and new sources of particulate matter 

emissions generaUy use control techniques which reduce lead emissions as 

one component of particulate matter. 

The Occupational Safety and Health 

Administration proposed regulations 

in 1975 to Umit occupational exposure 

to lead to 100 pg Fb/m°, 8-hour timeweighted average. The exposure Umit 

was based on protecting against effects, clinical or subclinlcaL and the 

mUd symptoms which may occur 

below 80 pg Pb/dL providing-an adequate margin of safety. The level of 

100 pg Fb/m0 is anticipated to limit 

blood lead levels ln workers to a mean 

40 pg Pb/dl end a maximum of 60 pg 

Pb/dL OSHA is presently reviewing 

the latest information on lead exposure and health effects in preparation 

for promulgation of the workplace 

standard for lead. 

The Department of Housing and 

Urban Development (HUD) has requirments for reducing human exposure to lead through the prevention of 

lead poisoning from ingestion of paint 

from buUdings, especiaUy residential 

dweUing. Their activities include (1) 

prohibition of the use of lead-based 

paints on structures constructed or rehabUitated through Federal funding 

and on all HUD-associated housing; (2) 

the elimination of the immediate 

hazard from lead-based paint; (3) notification of purchases of HUD-associated housing constructed prior to 1950 

which may contain lead-based paint; 

and (4) research activities to develop 

improved methods of detection and 

elimination of lead-based paint hazards, and the nature and extent of 

lead poisoning. 

The Consumer Product Safety Commission (CPSC) promulgated regulations in September 1977 which ban: (1) 

Potest and other surface coating materials containing more than O.OS percent lead; (2) toys end other> articles 

intenafcd for use by chUdren'bearing 

paint or other similar surface coating 

material containing more thea O.OS 

percent lead; and (3) furniture coated 

with materials containing more than 

0.08 percent lead. These regulations 

009009 AC® coM^ad^S 

tyre based on CPSC'o eoastainjii that it 

is in the publio interest to reduce the 

risk of lead poisoning to young children from ingsotkm of paint and other 

eimflfi-!? surf ace-coating materials. 

The Food ead Drug Administration 

(FDA) adopted In 1874 a proposed tolerance f os lead of 0 J ppn in evaporated milk and evagjora&ed skim milk. 

This tolerance is based on maintaining 

children's blood lead levels below 40 pg 

Pb/dL FDA has also proposed an 

action level of 7 pg Fb/ml for leachable lead in pottery and enamelware, 

although the exact contribution of 

such exposure to total human dietary 

intake has not been established. 

The Center for Disease Control 

(CDC) concluded in 1S75 that undue 

or increased lead absorption exists 

when a chUd has confirmed blood lead 

levels of 30-70 pg Pb/dl or an EP elevation of 60-18® tea Pb/dl except 

where the elevated EP level is caused 

by iron deficiency. 

In developing the lead air standard, 

EPA has estimated both individual 

and population blood lead levels which 

it regards as safe tergets. The Agency 

beUeves that these targets do not necessarily serve as precedents for other 

regulatory programs. There are three 

reasons for this view. 

(1) These targets were selected on 

the basis of what the Clean Air Act requires. Other programs have other legislative requirements which would lead 

to adoption of different hut equaUy legitimate goals. 

(2) The scientific data provided by 

the air quaUty criteria aUow comparison of air levels with blood lead levels, 

but analogous information is not avaUable for othe? media. At this time, 

there does not appear to be the same 

extent of Information about the 

impact on blood lead of lead ln food, 

water, end nonfood ingested items. Because of this, TOA, CPSC and other 

EPA standards have feeen based on estimates of acceptable daily dose rather 

than on blood lead targets. 

(3) Studies currently underway may 

provide new information relevant to 

estimating safe levels of lead exposure. 

COE3MEHTS B7 QsJSEB K3DISIAL AGBHCIES 

Comments on the proposed lead air 

quaUty standard were received from 

eight Federal Agencies. Five of the 

Agencies endorsed the air standard 

whUe three of the Agencies commented on specific issues end neither endorsed nor opposed the standard. The 

Center for Disease Control end the 

UJ3. PubUc Health 8ei?vt©B voiced support for the proBwaed standard of 1.5 

pg Pb/m° and urged tossing the decision on the standard solely on considerations of pubUc health. JS2C la fully 

satisfied that EP elevation does indeed 

represent a subclinical manifestation 

of lead toxicity end that young chUdren are the psBtugB&aifr -oasst at. risk 

from lead exposure, oMlfi eoaaa subgroups of children ara c& opsciai risk 

to lead because of conditions such es 

malnutrition, genetic factors, or iron 

deficiency. 

The Consumer Product Safety Commission endorsed the approach and 

some of the judgments made in arriving at the proposed air standard. 

CPSC concurred with the position 

that children are the population at enhanced risk to lead exposure, and that 

the goal of a mean population blood 

lead level for chUdren of 15 pg Pb/dl is 

sufficiently low to be protective of the 

population at enhanced risk of exposure. CPSC views the selection of EP 

elevation as the adverse health effect 

of concern as open to chaUenge and 

suggests basing the standard on a 

more generaUy recognized severe 

health effect. CPSC concurs that the 

contribution of nonair sources to lead 

body burden must be evaluated in setting the air standard and suggests that 

a larger nonair contribution, such as 

13.5 pg Pb/dl used in the California 

standard, might be considered. 

. The Food and Drug Administration 

commended EPA's proposal of an ambient air quaUty standard for lead. 

FDA agrees that chUdren aged 1-5 

years old comprise the most critically 

sensitive population. FDA concurs 

that 15 pg Pb/dl is a reasonable maximum blood lead level to UES as an 

average national goal for chUdren 

aged 1 to 5, although FDA suggests 

that for young chUdren the margin of 

safety is disturbingly narrow. The division of the 15 pg Pb/dl into 12 pg Pb/ 

dl for nonair sources and 3 pg Pb/dl 

for air sources was not unreasonable 

in FDA's view. 

The Occupational Safety and Health 

Administration endorsed EPA's proposed standard for lead and agrees 

with EPA that 15 pg Pb/dl as an average national blood lead level goal for 

young chUdren is reasonable. OSHA 

views their proposed standard of 100 

pg Pb/ms, 8-hour time-weighted average, and their establishment of 40 pg 

Pb/dl as the threshold effect level for 

workers as consistent with the EPA 

proposed standard. 

The Department of Transportation 

(DOT) endorsed the proposed standard of 1.5 pg Pb/m*. Based on en analysis of the impact of the proposed 

standard on the highway program, 

DOT concluded that it is highly probable that transportation-related violations of the proposed standard would 

be Umited to large urban areas. 

Ia commenting on tho processed 

standard, the Department of the Interior (DOI) expressed consepn that the 

burden for masting ths prost-osed 

standard wUI fall primarily QQ lead 

and -copper smelters and battery manufacturers, and commented on the* 

PBKaAB, on-sereo, voa. cs, co®. neo—TrKnaaaav, ©mes a s, ncro 

A-ssr-

-•'.&&.' 
, PJ5.,. 

3fes&; .dooMon on ground 

•T^a Teaadsea Valley 

?&£&&&• sscsffiSs comments 

il?? 

*!'.' 

a*r. 

•aS;./ 

.•siSfa' 

i»r 

f-jg^steaosai of Cbsaaasiifci4': 

:ES3ffia;(ffia tae "g«toa(MM' 

:.t£s&siPd; poiBrtiatfa«®8a-.8|^^~?Qaiaan. 

;''dfcasitton. o&©«il^ tea ofcai#litt e potam&el- impact of the stao-dcs^l <m the 

" pstroleum industry. 

THE FBDHML Rsptauro-CB METHOD 

The reference method for the determination of lead in suspended particulate-matter coUected from ambient air 

dficsslbss the appropriate techniques 

\tes- determining tho concentration of 

lead and its compoun&s as measured as 

elemental lead in the ambient air. A 

total of eight organizations submitted 

written comments on the method and 

two persons made comments at EPA's 

February pubUc hearing on the proposed air quality standard. Since proposal of the Federal reference method 

for lead, EPA has completed additional testing of the method and added 

new information on the precision of 

the extraction analysis procedure. 

Two of the commenters recommended the addition of a nitric plus hydrochloric acid extraction procedure. The 

extraction procedure of the proposed 

method contains only nitric acid. Use 

of a mixed acid procedure would 

permit the analyst to quantitatively 

es&r&ct more" metals than just lead, 

thereby allowing htm to analyze the 

Same extract for more than one metal. 

The analysis for lead would not be affected. EPA agrees that a mixed acid 

extraction procedure should be added, 

and the revised method contains a 

mixed nitric-hydrochloric acid extraction procedure. 

One commenter questioned the reliabUity of the air volume measured in 

the sampling procedure because of differences between initial and final flow 

rates caused by buUdup of particulate 

matter on the collecting filter. The 

method of sampling specifies that initial and final flow rates must faU between 40 and 80 cubic feet per minute 

and variations within this range cause 

only a sUght error. If the flow rate 

specification is not met, the sample 

should be voided. For these reasons, 

'SPA believes the air volume measuremisnt dbes not suffer Unduly from inE*cJmacles.' " .•;"•"."; 

afi question was raised as to the 

effect of variation fe lead content 

across the fUter of the coUected 

Qa&spl® v on lead caaJyc&j, since the 

saot&ifffi calla for analyst of-'only orie 

'BM© os one-twelfth of th© fUter. Our 

o<Kffe has shown that strips taken from 

different positions within the fUter 

, ean, osa ©cecsioa, produce different 

lead vilifies, hist- the effee6 appears to 

QPILUS AN® REGULATIONS 

be significant only when sampling 

nea? a heavUy traveled roadway. The 

proposed method recommends analyzing additional strips, when sampling 

near a roadway, to minimize this error. 

One commenter pointed out that the 

proposed sampling procedure does not 

coUect gaseous (organic) lead com-

' pounds and recommended that EPA 

consider requiring the use of a method 

for monitoring gaseous lead. As the 

criteria document states, reported ambient levels of gaseous lead are very 

low and EPA has determined that the 

effort required to carry out the difficult task of monitoring for ambient 

gaseous lead is not justified in view of 

the extremely low concentration. 

It was pointed out in the preamble 

to the proposed method that other 

analytical principles would probably 

be handled by provision for approval 

of the equivalent methods (40 CFR 

Part 53) proposed elsewhere in this 

FEDERAL REGISTER. TWO organizations 

submitted requests that alternate 

methods (X-ray fluorescence and 

anodic stripping voltametry) for lead 

analysis be declared equivalent to the 

reference method. These requests wUI 

be considered when the procedures for 

determining equivalency are promulgated. 

The final Federal reference method 

is based on measuring the lead content 

of suspended particulate matter on 

glass fiber filters using high volume 

sampling. The lead ts then extracted 

from the particulate matter with 

nitric acid f acUitated by heat or by a 

mixture of nitric acid and hydrochloric acid facilitated by ultrasonication. 

Finally, the lead content is measured 

by atomic absorption spectrometry. 

The reference method specified for 

lead measures the lead for a single 

sampling period by extraction of a 

portion of a high-volume glass fiber 

fUter used to coUect particulate 

matter over a 24-hour period. Some 

agencies may prefer to composite 

fUter strips from a number of sampling periods and extract and analyze 

it for lead. This procedure is acceptable provided the Agency shows that 

the compositing procedure results in 

the same average lead value as would 

be obtained from averaging individual 

values. 

Dated: September 29,1978. 

DOUGLAS M. COSTLE, 

Administrator. 

REFERENCES 

Angle, C. R. and M. S. Mclntire. Environmental controls and the decline of blood 

lead. Arch. Environ, mth. (ln press.) 1977. 

Azar, A., R. D. Snee, and K. Habibi. An 

Epidemiologic Approach to Community Air 

Lead Exposure Using Personal Air Samplers. Environmental Quality and Safety, 

Supplement Vol II-Lead 254-288 (1975). 

. Barltrop, D., C. D. Strehlow. J. Thornton, 

and J. S. Webb. Significance of high soil 

concentrations for childhood lead burdens. 

Environ, mth. Persp. Expt. Iss. 7:75-84. 

1974. 

Billick. I. A. Curran, and D. Shier. Presentation to the U.S. EPA Lead Subcommittee 

of the Science Advisory Board. Washington. 

D.C, October 7,1977. 

Pine. P. R., C. W. Thomas, R. H. Suho. R. 

E. Cohnberg, and B. A. Flashner. Pediatric 

Blood Lead Levels A Study in 14 Illinois 

Cities of Intermediate Population. JAMA 

221:1475-1479. September 25. 1972. 

Johanson, W. C. and J. P. Luby. A Report 

on a Study to Determine the Blood Lead 

Levels in Dallas Children. Dallas Health Department, Dallas. Tex. 1972. 

Johnson, D. E.. J. B. Tlllery. and R. J. Prevost. Levels of platinum, palladium and lead . 

in populations of Southern California. Environ. Health Persp. 12:27-33,1975. 

Landrigan, P. J., S. H. Oehlbach, B. F. Rosenblum, J. M. Shoults. et al. Epidemic Lead 

Absorption Near an Ore Smelter. The role 

of particulate lead. New England J. Med. 

292:123-129.1975. 

Manton. W. I. Sources of Lead ln Blood. 

Arch. Environmental Health. 32:149-156, 

1977. 

Rabinowitz, M. B. Lead contamination of 

the biosphere by human activity. A stable 

isotope study, PhD Thesis, University of 

California, Los Angeles, 1974,120 pp. 

U.S. Environmental Protection Agency. 

Air Quality Criteria for Lead Office of Research and Development. Washington, D.C. 

20460. EPA-450/8-77-017, December 1977. 

von Lindern, L and A. J. Yankel. Presentation to the Shoshone Heavy Metals Project 

Committee by Idaho Department of Health 

and Welfare, Boise, Idaho, September 4, 

1975. 

Yankel, A. J. and I.' von Lindern. The 

Silver Valley lead study. The relationship of 

childhood lead poisoning and environmental 

exposure. J. Air Pollut. Cont. Ass., August 

1977. 

40 CFR Part 50 is amended by 

adding a new g 50.12 and a new appendix G as foUows: 

§50.12 National primary and secondary 

ambient air quality standards for lead. 

National primary and secondary ambient air quality standards for lead 

and its compounds, measured as elemental lead by a reference method 

based on appendix G to this part, or 

by an equivalent method, are: 1.5 micrograms per cubic meter, maximum 

arithmetic mean averaged over a calendar quarter. 

(Sees. 109, 301(a) Clean Air Act as amended 

(42 U.S.C. 7409, 7601(a)).) 

APPENDIX O—REFERENCE METHOD POR THB 

DETERMINATION OP LEAD IN SUSPENDED PARTICULATE MATTER COLLECTED PROM AMBIENT AIR 

1. Principle and applicability. 

1.1 Ambient air suspended particulate 

matter is collected on a glass-fiber filter tor 

24 hours using a high volume air sampler. 

1.2 Lead ln the particulate matter Is solubilized by extraction wtth nitric acid 

(HNOO, facilitated by heat or by a mixture 

fcaKKlAI!. QS6J8W1Q, VOL 43, MO. 190—THURSBAY, OCTOQGQ 3, 1970 

f " 

r I ¥.M~ 
P.16 

mvr-y ' '•': -3M.v ii-A 

HUES AMD KOUiATlONt 

•«£: 

?&** 

V-:-

RO. and hydrochloric add (HCl) facfflf fey ultraftmleation. 

• •:•%£. The lead content of the sample is 

analymd by stotnie absorption spectrometry 

asbxr an afe-ccetyMe Bame, the 283 .1 or 

MTJ m Mad attM-p-ttioMne. and the optiSBHi tmSraHfeBntsf-eotflulQiis reoonmiendjed 

1.4 Tbe ottrasonleaCtan extraction with 

RNOt/HCI wfll extract metal* other than 

le*d from ambient particulate matter. 

X, Range, tensUMtv, and lower detectable 

{butt. The values given below are typical of 

the methods capabilities. Absolute values 

wta vary for Individual situations depending 

en tbe type of tnatrument used, the lead 

BBe, fend operating conditions. 

XI Ranee. The typical range of the 

method Is 0.07 to 7.6 pg Pb/m* «mm»im an 

upper linear range of analysis of IS ug/ml 

and an air volume of X400 m*. 

3J Sensitivity. Typical sensitivities for a 

1 percent change ln absorption (0.0044 abaox-bance units) are 0.2 and 0 J ns Pb/ml for 

the 217 JO and 283J nm lines, respectively. 

13 Lower detectable limit (LDL). A typical LDL to 0.07 n» Pb/m*. The above value 

was calculated by doubling the between-laboratory standard deviation obtained for the 

lowest measurable lead concentration in a 

collaborative teat of the method.U5) An air 

volume of 2,400 m* was assumed. 

3. Interferences. Two types of interferences are possible: chemical and light scattering. 

3.1 Chemical. Reports en the absence (I, 

2, 3, 4, S) of chemical interferences far 

outweigh those reporting their presence, (8) 

therefore, no correction for chemical interferences is given here. If the analyst suspects tbat tbe sample matrix ia causing a 

chemical interference, the interference can 

be verified and corrected for by carrying out 

the analysis wtth and without the method 

of standard additions^ 7) 

3.2 Light scattering. Nonatomic absorption or Ught scattering, produced by high 

concentrations of dissolved solids tn the 

sample, can produce a significant interference, especially at low lead concentrations. 

(2) The interference la greater at the 217.0 

nm Une than at the 283.3 nm line. No interference was observed using the 283.3 nm 

line with a similar methods 2) 

Light scattering interferences can, however, be corrected for lnstrumentally. Since 

the dissolved solids can vary depending on 

the origin of the sample, the correction may 

be necessary, especially when using the 

217.0 nm Une.. Dual beam instruments with 

a continuum source give the most accurate 

correction. A less accurate correction can be 

obtained by using a nonabsorbing lead line 

that ta near the lead analytical line. Information on use of these correction techniques can be obtained from instrument 

manufaa^tuTTrff' nnwruali 

H instrumental cuiieuUuu to not feasible, 

the interference can be eliminated by use of 

the ammonium pyrroudlnecarbodlthloatemethylisobutyl ketone, chelation-solvent extraction technique of Minnie preparations 8) 

4. Predsion and bias. 

4.1 The high-volume sampling procedure 

used to collect. smbtont air particulate 

matter haa a, between-laboratory relative 

standard deviation of 3.7 percent over the 

range 80 to 129 pg/m*.(>) The combined extraction-analysis pipueduie has an average 

within-laboratory relative standard deviation ef 5 to 6 percent over the range 1.5 to 

18 nt Pb/ml. and an average between laboratory relative standard deviation of 7 to 9 

percent ovar the same range. These values 

Include use of either extraction procedure.' 

4.1 single laboratory experiments and 

collaborative testing indicate that there to 

no significant difference ln lead recovery between the hot and ultrasonic extraction procedureaUS) 

5. Apparatus. 

6.1 Sampling. 

5.1.1 High-volume sampler. Use and calibrate the sampler as described ln reference 

10. 

5.2 Analysis. 

5.2.1 Atomic absorption spectrophotometer. Equipped with lead hollow cathode 

or electrodeless discharge lamp. 

5.2.1.1 Acetylene. The grade recommended by the Instrument manufacturer should 

be used. Change cylinder when pressure 

drops below 50-100 psig. 

5.2.1.2 Air. Filtered to remove particulate, oil, and water. 

5.2.2 Glassware. Class A borosilicate 

glassware should be used throughout the 

analysis. 

5.2.2.1 Beakers. 30 and 150 mL graduated. 

Pyrex. 

5.2.2.2 Volumetric flasks. 100-ml. 

5.2.2.3 Pipettes. To deUver 50. 30,15. 8, 4. 

2.1 ml. 

5.2.2.4 Cleaning. AU glassware should be 

scrupulously cleaned. The foUowing procedure ls suggested. Wash with laboratory detergent, rinse, soak for 4 hours in 20 percent 

(w/w) HNO* rinse 3 times with dtotiiloddeionized water, and'dry in a dust free 

manner. 

5.2.3 Hot plate. 

6.2.4. Ultrasonicatton water bath, unhealed. Commercially avaUable laboratory 

ultrasonic rw^ning baths of 460 watts or 

higher "cleaning power," Le., actual ultrasonic power output to the bath have been 

found satisfactory. 

5.15 Template. To aid ln sectioning the 

glass-fiber filter. See figure 1 for dimensions. 

5.2.6 Pizza cutter. Thin wheel. Thickness 

<lmm. 

5.2.7 Watch glass. 

5.2.8 Polyethylene bottles. Por storage of 

samples. Linear polyethylene gives better 

storage stability than other polyethylenes 

and Is preferred. 

5.2.9 Parafihn "M".' American Can Co., 

Marathon Products, Nennah, Wis., or equivalent. 

6. Reagents. 

6.1 Sampling. 

6.1.1 Glass fiber filters. The specifications given below are intended to aid the 

user ln obtaining high quality Altera with 

reproducible properties. These specifications have been met by EPA contractors. 

8.1.1.1 Lead content. The absolute lead 

content of Alters Is not critical, but low 

values are, of course, desirable. EPA typically obtains Altera with a lead content of <78 

jig/filter. 

It is Important that the variation In lead 

content from filter to filter, within a given 

batch, be small. 

6.1.1.2 Testing. 

6.1.1.2.1 For large batches of filters 

(>500 filters) select at random 20 to 30 filters from a given batch. For anall batches 

(<500 filters) a lesser number of Altera may 

be taken. Cut one %"x8" strip from each 

'Mention of commercial producta does 

not imply endorsement by the UJS. Environmental Protection Agency. 

VOL 4 * No. iM-TMiMMY r 

'"ap 

filter aaywnere-i 

strips, 

tions in sectioBs^.jiw^ff^-ya^y .&j^a^-^: .-

8.1.1.2.3 Odcukte tb»tat*l lMMl':ta < '"' 

filter aa 

v •• «"•"»#» "ate 

where: 

F»=Amount of lead per 72 square inches ot 

filter, ns6.1.1.2.3 Calculate the mesa. P* of the 

values and the relative standard deviation 

(standard deviation/mean x 100). If the relative standard deviation to high enough ao 

that, in the analysts opinion,, subtraction of 

Ft, (section 10.3) may remit in a significant 

error In tbe ns Pb/m* the batch should be 

rejected. 

6.1.L2.4. For acceptable batdna. xm tbe 

value of Ft to correct an lead aaalyaei (section 10.3) of particulate matter collected 

using that batch of Altera. If the 

are below the LDL (section 13> i 

tion to neceanry<-

6.2 Analysts.-' ,^ -, 

6.3.1 Concentrated (18.8 JO HJKfc. AC8 

reagent grade HKCC and mmmerriallriHaflahle redistilled HNO, harfound to hamnfffr-iBnfy low lead eaneentrationik 

6.3.3 

water). 

6J.4 3 Jf HKQ* -Bbto MJiillm ia need lb 

tbe bot extraction prace^praL 7-fc ntaiare, 

add 183 ml oT fSBeentoatjad HM« t» DJ. 

water In a 1 I v-qtometif-ie gfcafc. -Shake well, 

cool, and dilate ta vofcnne with JW. waste., 

Caution.* Nitric add fumes aro toxic, 

pare In a well ventilated fume hopdk ... 

6A5 0.46 Jf BTKVTWiraolatiml 

aa tbe matrix for calflwattOtt 

when using tbe hot extraction 

To prepare, add 3* ml of 

HNO, to D.I. water ts a 11 volonetrie 1 

Shake weU, tool, and dilute to euIuiM Wtth 

DJ. water. •:•„&-.«... 

6.2.6 2.6 if HNO.+0 to 0.9 MHCLTbIs 

solution is used ln the ultrasonic extraction 

procedure. The concentration of HCl can be 

varied from 0 to 0.8 JC. Directions are given 

for preparation of a 3.6 Jf HNO.+0J Jf HCl 

solution. Place 167 ml of concentrated HMO. 

Into al l volumetric flaak and add 77 ml ol 

concentrated HCl. 8Ur 4 to 6 houn, dOtate 

to nearly 1 I with DX water. eoat.baxMm. 

temperature, and dilute to I Li ~'%9V'

A

 -»--" 

6.2.7 0.40JfHNa + XjrHCLThtoJ 

tion to used as the soatite Cn 

standarda when using tb»altraMntB.cktraetion procedure. To 8ripare. aAS S9.MK:af 

concentrated HNOn P*n» thecal Ol HOt.required. to a 11 volumetrio.ftoA-Dflote to 

nearly 11 with DJ. water, socsfa akmflmmperature, and dilute tp 1 L To* aowunttt 

HCl required o n HR 0et«nntae4 rrestqP? 

foUowing equation: •-' ^ , - c „ ^ J 

Sif TWi^- ' li " «* ? 

( W l 

r u :••.:&••:. 

-vti^a.yf 

i-t. 

f-ir 
QUU3- aM&< (fceilllQiafl&KS 

P.17 

I HCl required. 

HCi'in Q.a.8. 

ia 7.2.2. 

LaSl-alteote, FMNO,)D. ACS reagent 

pus48j7.:.te3.0 percent.-Hect for 4 hours 

C'Cst&GSSl fa a desiccator. 

CQE&C$fen standards. 

CSit orfe-'/btahdard. 1600 pg Pb/ml ln 

'OD. Dtcbfcra 1.808 a of PWNO,), ln 0.45 M 

'Oo contained mal l volumetric. flask 

dilute to volume with 0.45 Jf HNO,. 

8.3 Booster standard, 1000 ug Pb/ml in 

Ot/HCtl Erepare as in 6.3.1 except use 

HNOo/BCl solution in 6.3.7. 

>re standards In a polyethylene bottle, 

available certified lead standsolutions ftiey also be used. 

7, ProcesJwB, 

7.1 Sampling. Collect samples for 24 

hours usihg the procedure described in reference 10 with glass-fiber filters meeting the 

specifications in 6.1.1. Transport collected 

samples to the laboratory taking care to 

mtailmlra contamination and loss of 

sample: (IT). 

7.2 Sample preparation. 

7.2.1 Hot extraction procedure. 

7:2.1.1 Cut a V«" x 8" strip from the exposed filter using a template and a pizza 

cutter cs described in figures 1 and 2. Other 

cutting procedures may be used. 

Lead In ambient particulate matter collected on glass fiber filters "has been shown 

to be uniformly distributed across the filter 

(i, 3, 11) suggesting that the position ot the 

strip Is unimportant. However, another 

study (12) has shown that when sampling 

near a road-way lead Is not uniformly distributed across the filter. The nonuniformlty has been attributed to large variations 

in particle sixe. il6) Therefore, when samp3$as near a road-way, additional strips at 

dlfierent positions within the filter should 

ba analyzed. 

.7.2.1.2 Fold the strip ln half twice and 

pibes in B 160-ml beaker. Add 15 ml of 3 Jf 

HNO! to cover the sample. The acid should 

completely cover the sample. Cover the 

beaker with a watch glass. 

7.2.1.3 Place beaker on the hot-plate, 

contained In a fume hood, and boll gently 

for 30 min. Do not let the sample evaporate 

to dryness. Caution; Nitric acid fumes are 

toxic. 

7.2.1.4 Remove beaker from hot plate 

and cool to near room temperature. 

7.2.1.5 -Quantitatively trapsfer the 

sample as follows: 

7.2.1.5.1 Rinse watch glass and sides of 

beater with DJ. water. 

7.2.1.5.2 Decant extract and rinsings into 

a ICO-ml volumetric flask. 

7.2.1.9.3 Add DJ. water to 40 ml mark on 

beefier, cover with watch glass, and set aside 

£ 3 Q minimum of 30 minutes. This Is a critl-

<££)-. otep and cannot be omitted since tt 

oQsros the HNOo trapped in the filter to diffflbs into the rinse water. 

"?4.1.a!<l Decant the water from the filter 

tiie volumetric floats. 

^,8.1.8.3 ' Rines filter and beaker twice 

cKSi SX water and add rinsings to volumetE&flCQb until total volume Is 80 to 88 ml. 

7.2.1.9.6 Sts^per flfiflfe end shake vlgorKKiy. Sst colda for approximately 5 minutes 

c? until focm haa dissipated. 

tf.8.1.8.7 Bring solution to volume wtth 

BX water, fiais thoroughly. 

7.2.1.5.8 Allow solution to settle for one 

hour before proceeding with analysis. 

7.2.1.3.9 If sample Is to be stared for subsequent analysis, transfer to a linear polyethylene bottle. 

7.2.2 Ultrasonic extraction procedure. 

7.2.2.1 Cut a V,"x8" strip from the exposed filter as described in section 7.2.1.1. 

7.2.2.2 Fold the strip in half twice and 

place in a 30 ml beaker. Add 15 ml of the 

HNO./HC1 solution in 6.2.6. The acid should 

completely cover the sample. Cover the 

beaker with parafilm. 

The parafilm should be placed over the 

beaker such that none of the parafilm is in 

contact with water in the ultrasonic bath. 

Otherwise, rinsing of the parafilm (section 

7.2.2.4.1) may contaminate the sample. 

7.2.2.3 Place the beaker in the ultrasonication bath and operate for 30 minutes. 

7.2.2.4 Quantitatively transfer the 

sample as follows: 

7.2.2.4.1 Rinse parafilm and sides of 

beaker with D.I. water. 

7.2.2.4.2 Decant extract and rinsings into 

a 100 ml volumetric flask. 

7.2.2.4.3 Add 20 ml D.I. water to cover 

the filter strip, cover with parafilm, and set 

aside for a minimum of 30 minutes. This ls a 

critical step and cannot be omitted. The 

sample is then processed as in sections 

7.2.1.5.4 through 7.2.1.5.9. 

NOTE.—Samples prepared by the hot extraction procedure are now in 0.45 M HNO,. 

Samples prepared by the ultrasonication 

procedure are in 0.40 M HNO. + X M HCl. 

8. Analysis. 

8.1 Set the wavelength of the monochromator at 283.3 or 217.0 nm. Set or align 

other instrumental operating conditions as 

recommended by the manufacturer. 

8.2 The sample can be analyzed directly 

from the volumetric flask, or an appropriate 

amount of sample decanted into a sample 

analysis tube. In either case, care should be 

taken not to disturb the settled solids. 

8.3 Aspirate samples, calibration standards and blanks (section 9.2) into the flame 

and record the equilibrium absorbance. 

8.4 Determine the lead concentration in 

ng Pb/ml. from the calibration curve, section 9.3. 

8.5 Samples that exceed the linear calibration range should be diluted with acid of 

the same concentration as the calibration 

standards and reanalyzed. 

9. Calibration. 

9.1 Working standard. 20 nB Pb/ml. Prepared by diluting 2.0 ml of the master 

standard (6.3.1 if the hot acid extraction 

was used or 6.3.2 if the ultrasonic extraction 

procedure was used) to 100 ml with acid of 

the same concentration as used in preparing 

the master standard. 

9.2 Calibration standards. Prepare daily 

by diluting the working standard, with the 

same acid matrix, as indicated below. Other 

lead concentrations may be used. 

Volume of 20 

pg/ml working 

atandard 

0 

1.0 

2.0 

2.0 

4.0 

8.0 

15.0 

30.0 

50.0 

100.0 

ml 

Pinal volume. 

ml 

100 

200 

200 

100 

100 

100 

100 

100 

100 

100 

Concentration 

HB Pb/ml 

0 

0.1 

0.2 

0.4 

0.8 

1.6 

3.0 

6.0 

10.0 

20.0 

9.3 Preparation of calibration cs m 

Since the working range of analysis will 

vary depending on which lead line is used 

and the type of instrument, no one set of 

instructions for preparation of a calibration 

curve can be given. Select standards (plus 

the reagent blank), ln the same acid concentration as the samples, to cover the linear 

absorption range indicated by the instrument manufacturer. Measure the absorbance of the blank and standards as in section 8.0. Repeat until good agreement is obtained between replicates. Plot absorbance 

(y-axis) versus concentration in us Pb/ml 

(x-axis). Draw (or compute) a straight line 

through the linear portion of the curve. Do 

not force the calibration curve through 

zero. Other calibration procedures may be 

used. 

To determine stability of the calibration 

curve, remeasure—alternately—one of the 

following calibration standards for every 

10th sample analyzed: concentration £ lpg 

Pb/ml: concentration § 10 fig Pb/ml. If 

either standard deviates by more than 5 percent from the value predicted by the calibration curve, recalibrate and repeat the 

previous 10 analyses. 

10. Calculation. 

10.1 Measured air volume. Calculate the 

measured air volume as 

V

n,= 

Q l + Q f 

x T 

where: 

V0=Alr volume sampled (uncorrected), m*. 

0,=Initial air flow rate, m'/min. 

Qi=Final air flow rate, m'/min. 

T=Sampllng time, min. 

The flow rates Q, and Q( should be corrected to the temperature and pressure conditions existing at the time of orifice calibration as directed in addendum B of reference 10, before calculation Vm. 

10.2 Air volume at STP. The measured 

air volume is corrected to reference conditions of 760 mm Hg and 25* C as follows. 

The units are standard cubic meters, sm'. 

VSTP " V

m * ^ " T l 

P

l

 xT 2 

Vm=Sample volume, sm', at 760 mm Hg 

and 298' K. 

Vn=Measured volume from 10.1. 

Pn=Atmospheric pressure at time of orifice 

calibration, mm Hg. 

P,=760 mmHg. 

T,=Atmospheric temperature at time of orifice calibration, *K. 

T.=288* K. 

10.3 Lead concentration. Calculate leod 

concentration ln the air aampie. 

I 

c • • 

(rt PWol « 109 at/strip x 12 strips/filter) - T. 

"SH> 

'ML 

P3KSA&, QQ@SS7SO, VC&. CS, NO. 194—TOyaSOAV, O€tf®20Q 8* -Kw> 

-••5S-W 
P.18 

QU&SS AN ® E^@<y)lkA1fll©Kl§ 46291 

where: 

C=poncentratlon, ns Pb/sm*. 

ug Pb/ml=Lead concentration determined 

from section 8. 

100 ml/strip=Total sample volume. 

13 strips/filter=Useable filter area, 7" x VI 

Exposed area of one strip, V," x 7". 

F0=Lead concentration of blank filter, fig, 

from section 6.1.1.2.3. 

Virr=Air volume from 10.3. 

11. Quality control. -

%" x 8" glass fiber filter strips containing 

80 to 2000 |ig Pb/strip (as lead salts) and 

blank strips with zero Pb content should be 

used to determine If the method—as being 

used—has any bias. Quality control charts 

should be established to monitor differences 

between measured and true values. The frequency of such checks will depend on the 

local quality control program. 

To minimize the possibility of generating 

unreliable data, the user should follow practices established for assuring the quality of 

air pollution data, (IS) and take part in 

EPA's semiannual audit program for lead 

analyses. 

12. Trouble shooting. 

1. During extraction of lead by the hot extraction procedure, it is important to keep 

the sample covered so that corrosion products—formed on fume hood surfaces which 

may contain lead—are not deposited in the 

extract. 

2. The sample acid concentration should 

minimize corrosion of the nebulizer. However, different nebulizers may require lower 

acid concentrations. Lower concentrations 

can be used provided samples and standards 

have the same acid concentrations 

3. Ashing of particulate samples has been 

found, by EPA and contractor laboratories, 

to be unnecessary in lead analyses by atomic 

absorption. Therefore, this step was omitted 

from the method. 

4. Filtration of extracted samples, to 

remove particulate matter, was specifically 

excluded from sample preparation, because 

some analysts have observed losses ot lead 

due to filtration. 

5. If suspended solids should clog the nebulizer during analysis of samples, centrifuge the sample to remove the solids. 

13. Autliority. 

(Sees. 109 and 301(a), Clean Air Act as 

amended. (42 U.S.C. 7409. 7601(a)).) 

14. References. 

1. Scott, D. R. et al. "Atomic Absorption 

and Optical Emission Analysis of NASN Atmospheric Particulate Samples for Lead." 

Envir. Set and Tech., 10, 877-880 (1976). 

2. Skogerboe. R. K. et al. "Monitoring for 

Lead in the Environment." pp. 57-66, Department of Chemistry. Colorado State University, Fort Collins, Colo. 80523. Submitted 

to National Science Foundation for publications, 1976. 

3. Zdrojewski. A. et al. "The Accurate 

Measurement of Lead in Airborne Particulates." Inter. J. Environ. AnaL Chem., 2, 83-

77(1972). 

4. Slavln. W., "Atomic Absorption Spectroscopy." Published by Interscience Company, New York, N.Y. (1968). 

5. Kirkbright, G. F., and Sargent, M., 

"Atomic Absorption and Fluorescence Spectroscopy." Published by Academic Press, 

New York, N.Y. 1974. 

6. Burnham. C. D. et al., "Determination 

of Lead in Airborne Particulates in Chicago 

and Cook County, IU. by Atomic Absorption 

Spectroscopy." Envir. Sci. and Tech., 3, 472-

475(1969). 

7. "Proposed Recommended Practices for 

Atomic Absorption Spectrometry." ASTM 

Book of Standards, part 30, pp. 1596-1608 

(July 1973). 

8. Koirttyohann. S. R. and Wen. J. W., 

"Critical Study of the APCD-6HBK Extraction System for Atomic Absorption." 4nat 

Chem., 4$, 1986-1989 (1973). 

9. Collaborative Study of Reference 

Method for the Determination of Suspended 

Particulates in the Atmosphere (High 

Volume Method). Obtainable from National 

Technical Information Service, Department 

of Commerce, Port Royal Road, Springfield, 

Va. 22151. as PB-205-891. 

10. "Reference Method for the Determination of Suspended Particulates in the Atmosphere (High Volume Method)." Code of 

Federal Regulations, Title 40, Part 50, Appendix B, pp. 12-16 (July 1. 1975). 

11. Dubois, L., et al., "The Metal Content 

of Urban Air." JAPCA, 16, 77-78 (1966). 

12. EPA Report No. 600/4-77-034. June 

1977, "Los Angeles Catalyst Study Symposium." Page 223. 

13. Quatity Assurance Handbook for Air 

PoUution Measurement System. Volume 1— 

Principles. EPA-600/9-76-005. March 1978. 

14. Thompson, R. J. et al.. "Analysis of Selected Elements in Atmospheric Particulate 

Matter by Atomic Absorption." Atomic Absorption Newsletter, 9. No. 3. May-June 

1970. 

15. To be published. EPA. QAB, EMSL, 

RTP, N.C. 277 U 

16. Hlrschler, D. A. et al.. "Particulate 

Lead Compounds in Automobile Exhaust 

Gas." Industrial and Engineering Chemistry, 49, 1131-1142(1957). 

17. Quality Assurance Handbook for Air 

Pollution Measurement Systems. Volume 

II—Ambient Air Specific Method*. EPA-600/ 

4-77/027a, May 1977. 

CFR Doc. 78-28050 Filed 10-4-78; 8:45 ami 

•Q 

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8rai°)lorao(n)ffsi(?J®in) Plsmo fe? ICKSKS 

AGENCY: Environmental Protection 

Agency. 

ACTION: Final rulemaking. 

SUMMARY: The regulations promulgated below, together with the current 

requirements of 40 CFR Part 51, set 

forth the reaulrements for States to 

follow in developing, adopting, and 

submitting acceptable implementation 

plans for the lead national ambient air 

quality standards (NAAOS'), promulgated elsewhere in the FEDERAL REGISTER. The implementation plans are required under section 110 of the Clean 

Air Act. Amendments to the existing 

regulations for implementation plans 

are necessary because lead differs 

. from other pollutants for which the 

existing regulations were designed. 

The amendments address the following topics: definitions of point source 

and control strategy; control strategy 

requirements; and air quality surveillance. 

EFFECTIVE DATE: This rulemaking 

is effective October 5, 1978; State implementation plans for lead are due by 

July 5,1979. 

ADDRESSES: U.S. Environmental 

Protection Agency, Office of Air Quality Planning and Standards, Control 

Programs Development Division (MD 

15). Research Triangle Park, N.C. 

27711. 

FOR FURTHER INFORMATION 

CONTACT: 

Joseph Sableski, Chief, Plans Guidelines Section, at the above address or 

at 919-541-5437 (commercial) or 629-

5437 (FTS). 

SUPPLEMENTARY INFORMATION: 

V 1. BACKGROUND 

On December 14, 1877, EPA proposed regulations for the preparation, 

adoption, and submission of implementation plans to achieve the national ambient air quality standards for 

lead, which were also proposed on that 

same date (42 FR 63087). EPA invited 

comments from interested persons and 

held a hearing on the proposed 

NAAQS and State implementation 

plan (SIP) regulations on February 15 

and 16; 1978. EPA received comments 

on the proposed lead implementation 

plan requirements from 25 comRMtLUS AM® RH@y(LAiri)®C33 

menters. Of these, there were 10 representatives from industry, 9 from 

State and local governmental agencies, 

4 from citizens' organizations and private citizens, and 2 from other federal 

agencies. 

2. SUMMARY OP COMMENTS AND 

RESPONSES 

The following discussion summarizes 

most of the comments received on the 

proposal. There were a few other comments that EPA felt were not significant to warrant discussion in the FEDERAL REGISTER and that did not affect 

the final regulation. A summary of all 

the comments received and EPA's response is available for public inspection during normal business hours in 

EPA's Public Information Reference 

Unit (PM 215), 401 M Street SW., 

Washington, D.C. 20460, telephone 

202-755-0707. 

2.1 POINT SOURCE DEFINITION 

There were several comments concerning the definition of a point 

source. One commenter Indicated that 

the definition of a point source is confusing and differs from that used in 

the provisions in the Clean Air Act 

concerning prevention of significant 

deterioration (PSD). Parts of that 

comment were directed toward the existing definition of point source in 

§ 51.1(k), which, as the commenter acknowledged, is not the subject of the 

proposal and will not be discussed 

here. 

Currently, § 51.Kk) defines point 

sources in terms of emissions per year 

and location of the source, as well as a 

listing of individual source categories. 

Currently, point sources of'.other pollutants for which NAAQS' exist that 

are located in urban areas are defined 

as those that emit poUutants in excess 

of 100 tons per year; point sources in 

less urbanized areas are defined as 

those that emit .pollutants in excess of 

25 tons per year. In light of the low 

level of the lead standard in relation 

to the other standards (e.g., for particulate matter), good reason exists to 

define point sources for lead at a lower 

level of emissions than that for the 

current set of pollutants for which 

EPA has established NAAQS'. Based 

on an analysis contained in EPA's 

"Supplementary Guidelines for Lead 

Implementation Plans," (» EPA is defining a point source of lead as "any 

stationary source causing emissions In 

excess of 4.54 metric tons (5 tons) per 

year of lead or lead compounds measured as elemental lead." This represents a slight change from the proposal, which failed to account for lead 

compounds. 

The significance of the definition of 

§51.1(k) is that the emission inventory, which is used to determine the 

extent of possible violations of the air 

quality standard and determine the effectiveness of control strategies, must 

include a determination of emissions 

from each point source. All emissions 

from sources other than point sources 

may be grouped together as area (or 

line) sources. 

The definition of point source, 

which was Intended to be based on 

actual emissions, differs from the definition in section 169 of the Clean Air 

Act (which pertains to prevention of 

significant deterioration), which is 

based on potential emissions. The 

reason for the difference is that for 

planning purposes, the inventory of 

existing sources must be based on an 

actual situation to be used as a baseline upon which one develops a plan. 

For new source review (including 

review for prevention of significant deterioration), one must be aware of the 

emissions that could be emitted from 

the proposed source as well as actual 

emissions; hence, the source size criteria for selection of new sources to be 

reviewed under the recently promulgated PSD regulations incorporate potential, as well as actual, emissions. 

The definitions of point source in 

§51.1(k) for all pollutants have been 

revised from the proposal to clarify 

that the size criteria are based upon 

actual emissions. This implies the 

emissions that are emitted after any 

control is applied. 

2.2 CONTROL STRATEGY 

A number of persons provided comments concerning the control strategy 

aspects of the proposed regulations. 

One commenter correctly noted a 

discrepancy between the list of source 

categories in §§ 51.80 ("Demonstration 

of attainment") and 51.84 ("Areas 

around significant point sources"), for 

which the State must perform an analysis. The lists should have been identical—! 51.84(a) should have also Included lead-acid storage battery manufacturing plants that produce 1,200 or 

more batteries per day. The rulemaking promulgated below incorporates 

this change. The criterion for production of batteries, which was based on a 

monthly standard, has been raised to 

2,000 batteries per day, however, to account for the slightly less stringent 

quarterly lead ambient standard. 

Several commenters indicated that 

the requirements in §§ 51.83 ("Certain 

urbanized areas") and 51.85 ("Other 

areas") appeared identical and therefore one of the sections was redundant. The difference between the two 

sections lies in the required geographical scope of the analysis. Section 51.83 

requires that the plan contain an analysis of each urbanized area that has a 

measured lead air concentration that 

is in excess of 4.0 fig/m* quarterly 

mean (monthly mean in the proposal). 

The distinguishing provision is that 

FEBSOAt QEOISTGQ, VOL 03, COO. IW—TO-UaSOAV, CCTCQGQ 3, 1970 

"3 

3 
P.22 

S-X. 

: « 

£tfae anatysia most Cover at least the 

-urbanised area. Section 51.88, 

tliAaother^haiufe requires that for 

any area (tatan-taed'drnat) with a re-

^•^^rdW-'te^-'«o^)iirtN*teo- that does 

''^*o|.raeet tite iiiillrtji^^Nifilki-d of JA 

-.jig/ln* quarterty niMTTiiiiHillily mean 

in the profibsallf tiw9*tan must contain an analyalstfa&ieist the area in 

the vicinity of the monitor that has recorded the concentration. Therefore, 

the* analysts may be restricted to an 

evaluation of only those sources 

within a relatively small radius from 

the monitor. • 

8evefml commenters suggested that 

the control strategy requirements 

insure that the burden for solving the 

lead air problem be equitably distributed between mobile and stationary 

sources. The commenters realized that 

either kind of control is expensive and 

difficult to implement. In response, 

EPA maintains that the allocation of 

the burden of control ln the SIP is the 

primary responsibility of the States, 

and' therefore EPA will avoid setting 

criteria in 40 CFR 51 that favor control of one source category over another. EPA acknowledges that measures that are expensive and difficult 

to implement may have to be adopted 

in order to demonstrate attainment of 

the lead standard. ^-

Two commenters Indicated that the 

regulations did not provide a satisfactory treatment to problems related to 

background concentration.' They 

claimed that a facility in an area of 

high background concentrations may 

be unduly, penalized in efforts to 

attain the standard. EPA acknowledges that this problem may exist. In 

most cases, how-aver, the high background air concentrations are generally due to other sources in the vicinity. 

It is the primary responsibility of the. 

State to allocate the burden of emmission control to the various sources 

causing the problem. Sources will have 

an opportunity to comment on the 

plan at the public hearing that is required before, the plan is submitted to 

EPA. 

One commenter suggested that EPA 

recommend, analysis of fugitive dust 

and on-premise soU before a State initiates a program ofa prolonged moni-

"tortng in the vidnity of gray iron 

foundries. As mentioned in the preamble to the propoBedtegulattons, EPA 

identified . gray ino a foundries as 

haying the potential for causing viola-

\ tions of the national standard for lead, 

but this identification vas based on 

limited data concerning the amount of 

fugitive emtsslora from Uie facilities. 

Although EPA does no* feel that the 

degree of confidence in this identification Justifies a- requirement far States 

to analyze all gray iron foundries (of 

which approximately 1£00 exist). EPA 

i States to consider analysis 

•yvB^-jm^ 

of these sources to the extent- that 

time and resources permit. The commenter's suggestion- concerning the 

analysis of fugitive dust and on-premise soil before undertaking extensive 

monitoring and analysis appear* to 

offer the potential for conserving 

scarce resources in that States may 

want to restrict their monitoring and 

analysis efforts to those plants with 

relatively high lead levels in dust and 

soil. 

T he same commenter also indicated 

that secondary lead smelters and similar sources probably cannot be modeled because of fugitive dust and low 

stacks. EPA recognizes the difficulty 

in quantifying fugitive dust and fugitive emissions and recognizes that low 

stacks will generally cause higher concentrations closer to the stack than 

will higher stacks. The Clean Air Act 

requires that an approved plan must 

demonstrate attainment of the standard, however. EPA has, based upon 

preliminary analyses, determined that 

secondary lead smelters and other 

sources listed in §51.84 have the potential for causing violations of the 

lead standard. EPA also believes that 

attainment of the lead standard 

around such sources can best be demonstrated by the use of an atmospheric dispersion model. In many cases. 

States will not have the time or resources to perform detailed studies to 

quantify the fugitive dust and fugitive 

emissions from individual -facilities 

and may have to rely on factors that 

were based on limited studies of other 

facilities or best estimates. In complying with §51.84, for cases where no 

ambient lead data were collected ln 

the vicinity of the source and where a 

State must thus estimate the air quality impact of the sources, the State 

will .have to decide for itself what level 

of control is warranted by the confidence in the data upon which the 

analysis is based. 

In another comment concerning 

modeling, one commenter from a State 

agency claimed that the models used 

for assessing the monthly impact of 

point sources are not accessible to 

most air pollution control agencies. In 

the initial analysis of the impact of 

the proposed standard on point 

sources, lt is true that EPA used the 

Oak Ridge National Laboratory model, 

"Atmospheric Transport and Dispersion Model" (ATM). (2) which is probably not available to most agencies. 

That analysis was revised subsequently, and another model was used, however. Also, EPA is recommending the 

use of other models, specifically those 

models for particulate matter described in EPA's "Guideline on Air 

Quality Models." (J) for modeling 

point sources for SIP development. 

These models are generally available, 

- ''-^..;^ : *£ik> '. 

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RMM l MOOTER, VOL O, NO. 194-THUWOlfr, 

A J" ;-- ~*g^ 

The 

only am Went 

downwind 

assessment of the impact at 

with a large fufftto emission 

nent. EPA acknowJfedges Oat 

ing studies, generally give a 

able estimate of tbe air quality 

of sources that.emlt fugitive en ., 

because no estimate need be made-of 

the fugitive, emissions, which are <atfl> 

cult to measure directly. Such studies 

cannot be done for many areas wJttpfri 

the time and resource conatiytota 

facing the States, however, and therefore EPA regulations require the lae 

of modeling around such point 

sources. States will have to make estimates of the fugitive emissions bawd 

on whatever information.may exist. 

EPA is. however., in, another psrtanf 

this FKDXRAL RxoJwaa giving advance 

notice of proposed rulemaking to require the installation of ambient monitors in the vicinity of three categories 

of point sources, ttiat have major fugitive emissions—FqSnary andse —----•• 

lead smelters ahd primary, 

smelters. 

monitors have begp .to p: 

years, the datajjpelded 

more accurate infonnation 

the nature an* magnitude 

problem from, these soi1 

those data bQcqm-f availabl 

require States to ' ""' 

mentation plans. .... 

Intends to devido]^ fugitive 

sion factors thaC,"are' - " 

than those th^-rtiiTen.^,^^^. 

One WTP^frafttfry^y^"*^"*"-'?" 

the regulatloniBiacerthe proof of 

pliance with mission regutetli." 

the stationary source'. The csmnu 

claimed that local enforcement 

des do not have the funds forcoi 

ous monitoring. ffil*«ponse, EPA 

found that there are no techniques 

continuous monitor&ig of lead emissions. The State wUI be required linder 

existing regulations (40 CFR 51.19) to 

carry out a source survetQanoe program which generally • consist*1

" of 

visual inspection of the installation of 

control equipment and 

emissions. ''"*%£• 

Several comments addressed 

concerning control of lead tn _ _ 

One commenter indicated that aiiyL 

duction of the lead content o f 

or any other . ""_ 

(presumably meaning control < 

or the control a&lead*mftstobi^ 

individual vehldfes) tha t 

needed In the OU'owes andT; 

current Federaldone throtqt ^ 

local 

taken steps to 

lead to 

down ot lead 

the- requtretteBtwith catalyst 

' J^ffi*! tf •OfeMfcr-sr.^CSi! 
The level of control of 

gasoline waa based on 

IsSMaittdno concerning lead air 

concentrations. Areos .tha t 

probleiag and theBf-^rill 

bla to demonstrate atthe lead standard through 

Source control or throwjh 

tnangsKKrtefcton control measures may 

have"to. adopt measures such.as re-. 

jaulreBaehts for further reduction of 

leo& in gasoline or control of lead 

emissions from the tailpipe of vehicles. 

Currently,- EPA does not foresee the 

need for additional mobile source control strategies and does not intend to 

require further nationally applicable 

lesd-ln-BSsoline reductions.. 

Other comments concerning further 

reductions of the lead content of gasoline suggested that such reductions be 

undertaken only after sufficient data 

is available to indicate that the lead 

air quality problem is geographically 

broad enough and only after a finding 

that stich a limitation is necessary to 

achieve a national ambient air quality 

standard. The commenters enumerated the problems with instituting further control of the lead content of gasoline. The commenters contended that 

application of more stringent local 

limitations of lead in gasoline could seriously disrupt the nation's gasoline 

distribution system, resulting in severe 

spot shortages, especially during the 

summer months when gasoline 

demand is at its highest. 

EPA recognizes this problem and advises the States to consider the comment. Also, under section 211(c)(4)(C) 

of the Clean Air Act, EPA will not approve State or regional programs for 

further reductions of lead content of 

gasoline unless the State demonstrates 

that no other reasonable measures are 

available. 

Also, two of the commenters recommended that 40 CFR Part Sl regulations be modifed to reflect the restrictions in section 211(c)(4)(C) of the Act 

regarding State limitation of the lead 

content of gasoline. In response, EPA 

has incorporated the intent of the Act 

into the definition of "control strategy" as it pertains to restrictions on 

fuel additives. 

Two commenters representing primary lead smelting companies recommended an alternative approach to 

protecting the health of persons from 

the ambient lead levels in the vicinity 

of primary lead smelters. They recommended that sources that cannot control emissions so that the lead standQag-d^Tfll bs met be allowed to conduct a 

public health screening and hygiene 

prograsau. aimed at reducing the 

amount of lead that children in the vtdnSSy-off the source take in and fasurtaO: thafe oafe blood lead levels are sattsfostsieffly maintained. 

RUU£S AN© KH@U6.A?IQW§ 

EPA believes that there are legal, 

technical, and equity problems with 

the programs that render it unacceptable as the sole means of implementation of the national standard for lead. 

Concerning the legal problem, such 

a program assumes that the air quality standard will be violated, and presumably, the plan will not contain a 

demonstration that the air quality 

standard will be attained. Under the 

Clean Air Act, EPA must disapprove a 

plan that does not contain a demonstration that the air quality standard 

will be attained by the mandatory attainment date. The Act provides for 

the protection of health through the 

standard setting, planning, and implementation processes; it does not allow 

for a surrogate procedure whereby 

public health may be protected even 

though the ambient standards are not 

met. 

Concerning technical problems, the 

relationship between emissions from a 

source and blood lead levels is not 

quantitatively certain. Even assuming 

a biological monitoring system were to 

be established, it is unclear what the 

source would have to do concerning its 

operation or emissions if the monitoring program revealed unacceptable 

blood lead levels. Even if a course of 

action were clear, the damage would 

have already been done, while the 

basic purpose of the standard setting 

and Implementation process envisioned by section 110 of the Act is prevention of public health problems. 

Concerning equity, the biological 

monitoring program would inconvenience the very people that are supposed to benefit from the Act. The Act 

envisioned that all people have an 

equal right to healthy air. The commenters who recommended that biological monitoring approach apparently believe that people who happen to 

live in areas with elevated lead levels 

should not be accorded equal protection, but should be made to pay extra 

for their health through presumably 

continuous participation in a blood 

sampling program. If a person did not 

want to participate, it is doubtful 

whether he could be forced to, so 

therefore his health could be placed in 

Jeopardy. 

One commenter representing a primary lead smelter warned that enclosure of smelter operations to control 

fugitive lead emissions may present a 

severe occupational health hazard to 

employees who must work within the 

enclosed space. EPA realizes these potential problems. If a source installs 

such enclosures, it must of course also 

meet any applicable regulations set 

forth by the Occupational Safety and 

Health Administration as well as control emissions to the extent specified 

in the applicable implementation plan. 

One other commenter expressed 

concern that there appears to be nothing that can be done in areas where a 

source is employing best available control technology, yet the standard is 

still not being met. The Act requires 

that for approval, an Implementation 

plan must demonstrate that the control strategy contained in the plan is 

adequate to attain and maintain the 

NAAQS. EPA realizes, however, that a 

plan which meets this criterion may, 

even after full implementation, not actually result In attainment by the attainment date. This would gererally 

indicate that assumptions concerning 

the amount of emissions and the relationship between emissions reductions 

and air concentrations that were made 

when the plan was developed eventually were proven erroneous. If an approved plan is later found to be inadequate to attain the standard, EPA 

will require the State to revise the 

plan. If that plan has already required 

all measures short of those that would 

force significant source closures, EPA 

will at that time decide whether the 

closure must be effected or whether 

there are alternatives to this in the 

discretion given to EPA under the Act 

In sections 110 or 113. States should 

make every effort to develop and 

submit plans that demonstrate attainment of the standard using the best 

data available. 

Several commenters from State air 

pollution control agencies indicated 

that the development of lead SIP's 

will be difficult within the timeframe 

provided. EPA realizes that the development of the lead plans will be competing in priorities and resources with 

the development of plan revisions by 

title I, part D, of the Clean Air Act for 

nonattainment areas. Where a State 

needs additional assistance in the development of its lead plan, or where it 

is unsure as to the priority of development of its lead plan, the State should 

consult with the appropriate EPA regional office. 

2.3 AIR QUALITY MONITORING 

Several commenters recommended 

that a minimum number of samples be 

taken to determine whether the standard is being attained. Also, several persons commented that the sampling 

should be performed more frequently, 

such as daily. One person indicated 

that determination of the attainment 

status should be done by. annual 

rather than monthly averaging. At 

least a 3-month average would be more 

desirable. Another person indicated 

that the shorter the averaging period, 

the more the number of samples 

should be. 

Concerning the minimum number of 

valid samples needed to determine an 

average, it is general practice to require at least 75 percent of the ochedPQK32AS. QBOISTSQ, VOL. 43, NO. 194—THUQSDAY, OCTOBEQ 9, 1970 

:.w-... 

"M?JJib-k-uiiuujUlU^,,, luttlH 
^uled samples to be valid. EPA will prepare a guideline on this and other 

isgueo concerning the determination of 

attainment of the standard. Concerning the frequency of crumpling, EPA is 

promulgating a national ambient air 

quality standard for lead ln this FEDERAL REGISTER that la based on a calendar quarter, rather- than calendar 

month as had been proposed. EPA has 

determined that a sampling schedule 

of once every 6 days is adequate to 

give a representative sample for a 

quarter. 

One commenter indicated that monitoring the inner city area should be 

given top priority because the vehicle 

mix in these areas favors older cars 

that burn leaded gasoline. EPA's response is that if maximum exposures 

occur in these areas, then monitoring 

these areas should in fact receive first 

priority. The determination of acceptability of the sites will be the joint responsibility of the States and the cognizant EPA regional office. 

One commenter recommended that 

EPA change the recommendation in 

the draft "Supplementary Guidelines 

for Lead Implementation Plans" (i) 

for locating lead monitors near roadways that are at or below grade level 

rather than near elevated roadways. 

The commenter suggested that the 

guideline require measurements to be 

representative of emissions and environmental exposure. The commenter 

indicated that the proposed guidance 

would exclude monitoring play areas 

that are located beneath elevated 

' roadways. EPA agrees with this comment. The purpose behind excluding 

below grade level monitoring and monitoring near elevated roadways was to 

insure adequate exposure at the monitoring site. If significant population 

exposures consistent with the averaging time of the NAAQS were encountered in these situations, then monitoring in these locations would meet 

the intent of the guidance. EPA has 

revised .the siting guidance to account 

for these considerations. 

Several comments were directed 

toward the recommended location of a 

monitor at a given location. Two persons indicated that the allowance of 5 

meters in elevation of lead air monitors is too high and that it should be 

changed or should allow for numerical 

adjustment of the data. One person 

suggested that the monitors be required to be placed closer to roadways 

because he felt that would be more 

representative of exposure; another 

suggested that the monitors are required to be placed too close to the 

street already in some cases and that 

the data from the monitors would be 

unrepresentative. EPA proposed a 

range of heights San lead monitors 

from & to S meters above ground leveL 

The proposed required dtetoace from 

CMsQS- AC® RtI@5^W§£3§ 

major roadways for the peak concentration site was 5 to 15 meters. The 

Intent was to sample ambient air to 

which significant portions of the population are being exposed over the 

averaging time of the standard. 

During a typieal day, even the most 

susceptible population group does not 

spend more than one-half of their 

time in the ambient air below the 2-

meter level or within 15 meters of a 

major roadway. They are indoors or at 

considerable distances from roadways 

for the remainer of their time. Consequently, requiring samplers to be 

placed below 2 meters above the 

ground or closer than 5 meters to a 

roadway would lead to concentration 

measurements that would be unrepresentative of lead exposures. Further, 

some range of heights and distances is 

necessary due to practicalities involved 

In finding suitable sites, power availability, protection against vandalism, 

allowing free pedestrian movement 

along sidewalks, etc. 

One commenter recommended that 

the criteria for monitoring in the vicinity of roadways not include specific 

distance restrictions, such as the requirement for placement of monitors 

between 5 and 15 meters from the 

traffic lane. The commenter indicated 

that many areas do not have housing 

that close to major roadways and 

therefore the numerical restrictions 

would be counterproductive to insuring accurate monitoring of maximum 

population .exposure. EPA's response 

is that even though housing may not 

exist that close to roadways in all 

cases, the public has access to many 

such areas. 

One commenter recommended that 

the monitoring • guidelines require 

monitoring lead below ground level in 

public places such as subway stations 

and underground shopping areas. In 

response, EPA's monitoring guidance 

was written for purposes of determining attainment of a standard. Locating 

monitors ln subways to determine exposures would be considered special 

purpose monitoring and thus could be 

performed if desired by the State or 

local agency. EPA however, does not 

feel that monitors placed in these situations would yield data suitable for developing implementation plans or determining national trends and strategies and thus will not require it. Furthermore, since no member of the 

public spends more than perhaps 8 

hours out of 24 hours in such locations, monitoring there would not be 

representative of population exposure 

for a standard based upon 24-hour 

sampling for an entire quarter. 

One commenter recommended that 

the regulations require ambient monitoring in the vicinity of major point 

sources. Hot doing so may allow potentially significant public health impacts 

that result from fugitive emissions eJL 

major point sources to bs ignored, tomentioned above, to ancfchis? pas^-OiJ, 

this FEOEHJU. JteuisTSa. EPA ia gto&OQ 

advance notice of proposed rulesBE&*. 

ing to modify the regulations to K3-a. 

quire source owners or operateD Wmoaltor in the vicinity of primary rmfl' . 

secondary lead smelters and prtot£7y 

copper smelters. EPA chose ths^a 

source categories because they WQ 

considered to have the potential for 

causing the greatest concentrations of 

air lead in their vicinity and because 

the nature and magnitude of their fugitive emissions are relatively unknown compared to other source categories. The regulations will continue 

to vest authority ln the regional administrators to require monitors in the 

vicinity of other sources. EPA wtil prepare guidance concerning the recommended number and siting of monitors 

in the vicinity of lead point sources. 

Another commenter claimed that 

the regulations do not adequately address the locations where air quality 

samples will be taken and at what distance from a facility they cl't o 

taken. As mentioned above, EPAauffllll 

develop guidance cm the placoaEsnfc oS 

lead monitors to the vicinits?; ®2 notofc 

sources. The guidance for-Sccattea* 

monitors elsewhere is highly spedlffls. 

in that the distances from otateECtions and interferences are quantitatively described. Xt is not possible from 

a national perspective, however, to develop general regulations that'^s-ald 

cover every conceivable situation that 

could occur without mailing the regulations unduly complex. 

One comments? suggested that the 

lead monitors should not bs--required 

to be permanent until the-E&ote has 

more experience in oampling and mon* 

itoring lead. Also, several commenters 

recommended that EPA require Initial . 

monitoring by mobile vans or other 

procedures to locate the most critical 

sites. EPA does not intend that the required monitoring stations would 

remain at one place in perpetuity. 

EPA does, however, need some stability in monitoring site locations toallow for trends analysis. If a stattaonce established is later found to tea 

unrepresentative, it should be moved 

to a new location. EPA agrees wttEa ths 

intent of the comments and hao 

always encouraged special. puifB3C& 

monitoring prior to establtehlng'a pacv 

manent monitoring station. KPA CTUI 

not require resource-intensive KWOC©-

dures to locate critical sites, hooevesr.. 

Several coEamesiSsro. jreocsismiendsd 

that the regula&toiiEi EeQuArQ • .Htsca 

than a minimusa of to o saosultao.' BS? 

area. EPA's response is t&at toe rea©--

latioms da not preclude plcstao oaaft 

more than to o taaaitors. JSPA to talks?* 

ested nafctamally to oWtatataa' ffialy 

enougfo data to esftafolltefa.o.fe&a feresd!? 

PGE3QA0. QS@0S?i3a, WJ3. <B, K®. 190—7KOSSAV, ©©TECSSl 3, Ht£0-

""!•£ * =• 
ti.&'^f*^*-^ 

* 

I 

sa 

1% 

l^Cifesatea-stf t&o. Federal programs 

S^ E~MS-'to-tSiQ-s^testtaa of autoEEatefflo-. lee$ esaissffim .era., couatos decreeoso to ie^ate-eaassSteo^ssas, and. 

daSsmiae Waa agjpposfesaatQ-'.attainment' stat e 'of areao;' E=Bff©s3rsaore,. 

ti&a regulations would eHos? ®?A to reguteo additional monitors on a-eose-ibycase basis where EPA believes that 

two monitors are Insufficient to determine whether the national standard is 

being attained and maintained. 

One of the commenters who recommended that the regulations require 

more than two monitors per area objected to placing responsibility on the 

EPA regional offices to require additional monitors and determine their 

location. The commenter claimed that 

this precludes both accountability of 

the State's actions and public participation. EPA's response is that requiring a limited number of samplers specifically to meet data needs at the national level and leaving the determination of the number and location of the 

remaining stations to the State network to the State and the regional 

office is consistent with the recommendations of EPA's Standing Air 

Monitoring Work Group 

(SAMWG). (4) In a recent action (43 

FR 34892, published Aug. 7, 1978), 

EPA proposed that the locations of 

stations (for all pollutants) need not 

actually be Included in the implementation plan, but the plan must contain 

a monitoring program which includes 

a monitoring network that is based 

upon negotiations between the State 

and the EPA regional office. The plan 

would also have to contain a commitment to annually review the adequacy 

of the network and to establish new 

stations and relocate or terminate existing stations as needed in order to 

keep the network responsive to data 

needs. EPA feels that if the entire 

system were part of the SIP, the only 

way the State could make modifications would be to propose the change, 

hold a public hearing, and submit the 

change to EPA as a' plan revision. EPA 

would then have to propose to approve 

the revision, entertain public comment, and then finally promulgate its 

approval. EPA feels that this process 

ia too time-consuming and would 

defeat the purpose of the annual 

review, which is to make timely adjustments to the network. Also, EPA feels 

that the potential benefits from this 

process would be top- few to warrant 

its implementation. The proposed requirements concerning air quality 

monitoring, however; would require 

that the locations of the monitors be 

available at all Umea for public inspection. Therefore, when the State revises its SIP to order to implement the 

forthcamtoQ ate qaali6y monitoring requirements, the public can at that 

time comment on the State system. 

The public can also comment on 

changes to the networks at any time 

by submitting written comment on 

changes to the State or EPA regional 

office. 

One commenter indicated that the 

low-volume sampler compares-favorably in measurement with the highvolume sampler, which -is the reference method for collection of the 

sample, and excludes larger particles 

that are not respirable and which the 

commenter feels are not significant 

from a health standpoint. The commenter implies that EPA should allow 

the use of the low-volume sampler. 

Low-volume sampling will be allowed 

if the agency that wishes to use it 

demonstrates that the method is 

equivalent to the reference method, 

using the procedures that EPA is proposing in another portion of this FEDERAL REGISTER. 

(SAROAD) system. The find regulation below retains this requirement, 

but provides the regional administrator with the authority to waive the requirement concerning the format of 

the data. 

3 .3 USTS OV URBANIZED AREAS 

There were several errors in the two 

tables of areas ln the preamble to the 

proposal In table 2, "Urbanized areas 

with lead air concentrations exceeding 

or equal to 1.5 ng/m', maximum 

monthly mean (1975)". the Norfolk, 

Va. AQCR number should have read 

223 instead of 233. Table 3, "Urbanized 

areas with lead air concentrations 

equal to or exceeding 4.0 ng/m*. maximum monthly mean (1975)" should 

have read as follows: 

"AQCR Urbanized area 

3.0 OTHER CHANGES FROM PROPOSAL ,„ _ , . .. 

19 _. „ Phoenix. Ariz. 

3.1 AIR QUAUTY SURVEILLANCE £ — jffffi^" 8 **"* '

 CML 

REQUIREMENTS SO San Francisco—Oakland. Calif. 

30 ....._.... San J033. Calif. 

E PA ha s revised th e air quality SUr- 67 Chicago, DX—northwestern Indiana. 

veillance requirements for lead slight- »is — Doiiaa.Teu. 

ly from the proposal to render them 

clearer and more consistent with the SOURCE Data from EPA's Environmental 

general air quality surveillance re- Monitorina Support Laboratory, Statistical 

quirements currently under revision

 ant* Technical Analysis Branch." 

that will apply to all poUutants. These These corrections, however, are now 

revised general requirements will academic, since the averaging time'of 

closely follow and implement the rec- the lead standard is now quarterly, 

ommendations of EPA's Standing Air Therefore, tables 3 and 3 are revised 

Monitoring Work Group. <«)> The sig- t 0 reflec t t ^ quarterly average. Table 

nificant revisions of the lead require- 2 (renumbered table 1) appears at the 

ments from the proposal include the en d o f th e preamble. Table 3, revised 

following: A change of the date by t 0 reflec t ^ g quart e r i y average, now 

which the entire monitoring system contam s onl y on e area, th e LOS Angemust be estabUshed; deletion of the ie8_Long Beach. CaUf.. urbanized 

SMrv n TSS& . „ now^iPd «K £ currently available to EPA. and generH ^ 5 ? J iJS^Sr^SS^ * ? £ ^ th e

 quarterly averages available 

£2^l«£ ? ^"f^J 1?

8

 S^"0118 > <°r are not truly representative due to inNAMS ) and State and Local Air *,, , a: j . w ^ *w J T 

Jr^^«Jeio*^r,« » ^ , "«t 4MO ^ sufficient data. There are other date 

monitoring stations (or SLAMS ). «„n.w» *« 0 ... „ _...» 1---1 „i„ -„ii,. 

These terms have not yet been defined "*"•"? *°

 S ' t * w £SL^ . ^ w 

h v regulatio n so referenc e t o the m Is

 tlo n contro 1

 agencies, however, tha t 

meSLT'Mo^Slon £ ST.S «* **- * «*

 other

f«"

 hav e 

quirement that the plan contain a de- concentrations, tot excess.of the concenscription of the monitoring system; trations specified to the criteria for 

and revision of the "Supplementary performing the analysis. 

Guidelines on Lead Implementation 3 4 EXAMPLE LEAD CONTROL STRATEGY 

Plans" to account for location of monitoring stations in urban street can- The preamble to the proposal lndiyons. cated that EPA was developing an exAs mentioned in the preamble to the ample lead control strategy to assist 

proposal, EPA will eventually incorpo- the States in developing their lead Imrate the lead monitoring requirements plementation plans. The preamble ininto the air quality monitoring re- dicated that the example was schedquirements that apply to all pollut- uled for completion by March 1878. 

ants for which NAAQS' exist. Because EPA has received an extension for promulgating the national 

ambient air quality standard for lead, 

because the example control strategy 

would be based on the final implementation plan regulations promulgated 

below, and because of other delays. 

the example controls strategy will 

3.2 REPORTING o r DATA BASS 

Under the proposal in § 51.86(c), the 

State would have been required to 

submit the air quality data collected 

since 1974 ln the format of EPA's storage and retrieval of aerometric data 

i 

FEBKICIAE, QBetsmn, VOL 43, NO. 194—TO5J0S®AV, ©STOOGd 8, IWO 
P.26 

l a 

srobabiy not be available until November or December of 1978. 

4.0 REFERBHCES 

1. "Supplementary Guidelines for Leod 

Implementation Plans." V& Environmental 

Protection Agency, OffteQ of Air Quality 

Planning and Standards. Research Triangle 

Parte. N.C. 27711. (OAQPS No. 1.2-104). 

2. Culkowski. W. M. and M. R. Patterson, 

"A Comprehensive Atmospheric Transport 

and Diffusion Model." (ORNL/NSR/EATS17. Oak Ridge National Laboratory, Oak 

Ridge, Tenn., 1976. 

3. "Guideline on Air Quality Models." 

Monitoring and data Analysis Division, 

Office of Air Quality Planning and standards, O.S. Envlronmentai Protection 

Agency. Research Triangle Park, N.C. EPA450/2-78-027 (OAQPS No. 1.2-080), April. 

1978. 

4. "Air Monitoring Strategy for State Implementation Plans." Prepared by the 

Standing Air Monitoring Work Group. U.S. 

Environmental Protection Agency, Office of 

Air and Waste Management, Office of Air 

Quality Planning and Standards, Research 

Triangle Park. N.C. 27711. EPA-450/2-77-

010. June. 1977. 

TABLE I—Urbanized Areas With Lead Air 

Concentrations Exceeding or Equal to l.S 

ng/m'. Maximum Quarterly Mean (.1975) 

AQCR No. Area 

004 Birmingham. Ala. 

015 Phoenix. Ariz. 

031 Fresno, Calif. 

024 Los Angeles—Long Beach. Calif. 

028 Sacramento, Calif. 

024 San Bernardino—Riverside. Calif. 

029 San Diego. Calif. 

030 San Francisco—Oakland. Calif. 

030 San Jose, Calif. 

038 Denver. Colo. 

043 New York, N.Y.—northeastern New 

Jersey. 

042 Waterbury, Conn. 

042 Springfield, Chicopee-Holyoke, 

Mass.—Connecticut. 

045 Wilmington, Del.—New Jersey. 

048 Philadelphia, Pa.—New Jersey. 

047 Washington. D.C—Maryland—Virginia. 

067 „ Chicago, 111.—northwestern Indiana. 

131 Minneapolis—St. Paul, Minn. 

070 St. Louis. Mo.—Illinois. 

013 Las Vegas. Nev. 

148 Reno. Nev. 

184 Oklahoma City. Okla. 

151 Scranton.Pa. 

244 San Jyan. P.R. 

200 Columbia, S.C: 

202 Greenville. S.C. 

207..... Knoxville, Tenn. 

018 Memphis. Tenn.—Mississippi. 

215 Dallas. Tex. 

153 El Paso, Tex. 

218 Houston. Tez. 

SOURCE: Data from EPA's Environmental 

Monitoring Support Laboratory, Statistical 

and Technical Analysis Branch. 

Dated: September 29,1978. 

DOUGLAS M. COSTLE, 

Administrator. 

The Code of Federal Regulations, 

Title 40, Chapter I, Part 51, is amended as follows: 

1. In g 91.1, paragraph (k) is revised 

and paragraph (n) is amended by 

adding paragraph (11) as follows: 

§ Sl.l Definitions. 

(k) "Point source" means the following: 

(1) For particulate matter, sulfur 

oxides, carbon monoxide, hydrocarbons, and nitrogen dioxide— 

(i) Any stationary source the actual 

jejtpissions of which are in excess of 

90.7 metric tons (100 tons) per year of 

the pollutant in a region containing an 

area whose 1970 "urban place" population, as defined by the U.S. Bureau of 

the Census, was equal to or greater 

than 1 million; 

(il) Any stationary source the actual 

emissions of which are in excess of 

22.7 metric tons (25 tons) per year of 

the pollutant in a region containing an 

area whose 1970 "urban place" population, as defined by the U.S. Bureau of 

the Census was less than 1 million; or 

(iii) Without regard to amount of 

emissions, stationary sources such as 

those listed in appendix C to this part. 

(2) For lead, any stationary source 

the actual emissions of which are in 

excess of 4.54 metric tons (5 tons) per 

year of lead or lead compounds measured as elemental lead. 

(n) 0 0 0 

(11) Control or prohibition of a fuel 

or fuel additive used In motor vehicles, 

if such control or prohibition is necessary to achieve a national primary or 

secondary air quality standard and Is 

approved by the Administrator under 

§ 211(c)(4)(C) of the Act. 

2. Section 51.12, paragraph (e) is 

amended by adding subdivision (3) as 

follows: 

§ 51.12 Control strategy: General. 

(e) ° ° ° 

(3) This paragraph covers only plans 

to attain and maintain the national 

standards for particulate matter, 

sulfur oxides, carbon monoxide, photochemical oxidants, hydrocarbons, 

and nitrogen dioxide. 

3. Section 51.17 is amended by (1) revising the heading to read "Air quality 

surveillance: Particulate matter, sulfur 

oxides, carbon monoxide, photochemical oxidants, hydrocarbons, and nitrogen dioxide," and (2) adding paragraph (d) as follows: 

§ 51.17 Aii? qadl£Jj>.> oEjvoSfaicee: • Postaiilate matter, odfe? onCta, eos-feua Ewwaoside, photoctMiKate&l OEldomto, fcy&©> 

carbons, and nitrogen dtozAde. 

(d) This section covers only plans to 

attain and maintain the national 

standards for particulate matter, 

sulfur oxides, carbon monoxide, photochemical oxidants, hydrocarbons, 

and nitrogen dioxide. 

4. A new § 51.17b is added as follows: 

§ 51.17b Air quality surveillance: Lead. 

(a) This section covers only plans to 

attain and maintain the national 

standards for lead. 

MONITORING IH CERTAIN AREAS 

(b) The plan must provide for the establishment of a monitoring system 

that contains at least two permanent 

lead ambient air quality monitoring 

stations in each urbanized area (as defined by the U.S. Bureau of the 

Census)— 

(1) That has a 1970 population 

greater than 500,000; or 

(2) Where lead air quality concentrations currently exceed or have exceeded 1.5fig/m' quarterly arithmetic mean 

measured since January 1,1974. 

(c) The EPA Regional Administrator 

may specify more than two monitoring 

stations if he finds that two stations 

are insufficient to adequately determine if the lead standard is being attained and maintained. He may also 

specify stations ln areas outside the 

areas covered in paragraph (b) of this 

section. 

(d) The monitoring system must contain at least one roadway type monitoring site and at least one neighborhood site and be sited in accordance 

with the procedures specified in EPA's 

"Supplementary Guidelines for Lead 

Implementation Plans." 

(e) The monitors must be operated 

on a minimum sampling frequency of 

one 24-hour sample every 6 days. 

(f) Existing sampling sites being 

used for sampling particulate matter 

may be designated as sites for sampling lead if they meet the siting criteria of "Supplementary Guidelines for 

Lead Implementation Plans." 

(g) The plan must provide that all 

lead air quality monitoring stations 

will be established and operational as 

expeditiously as practicable but no 

later than 2 years after the date of the 

Administrator's approval of the plan 

for the stations specified under paragraph (b) of this section. 

(h) The analysis of the 24-hour samples may be performed for either individual samples or composites of Uie 

samples collected over a- esferator 

month or quarter. 

(i) [Reserved] •'•*'. 

POSSUM OHetSTSQ, VOL 43, NO. ISO—TOUC1SSAV. ©-CTO02Q S, 1970 

MMM ^M^^x? 

...UJ 
feaagSSgaga^afeg---.. 

'"''-"""'"''""'v5.*= iS*g-3 

iso ALL 

•jtt-.-

•••swfc-*ai*iae 

r having 

IttipMiie 

*«P * • 

flVP PuBHC 

-the' 

"ISie€&Oi1B&Ba^mx&L include the follb^rtnvfidaeiBadtmr" 

<1> Itt e SAROAD stte identification 

format ^fiis'Sil'-. H-s^'a-: (2), Th-4: ..sampling and analysis 

metho^-a^-V'>%*•«•;

 ;a;

 '•' 

, <a)T^SMnpHn«aehedule. 

<k> •nja^j^nnttodiw method used in 

any stetion %th e monitoring systems 

required taa^ttr^ection must be a reference or"ejjallafciut method for lead 

aa defined m | «V1 otttols chapter. 

t» A.-SWW subpart E is added as follows; ~ ..':

 •,.;,..... _Vi , 

Subpil 1 fcbliot SbnHor- Uad 

Sec 

81.80 Demonstration of attainment. 

point 

11*. WMafc Clean Air 

Aet «B amended X4AMA.C 7410, W01). 

Subpart E—Control Strategy: Load 

15UW Demonstration of attainment. 

(a) Bach plan must contain a demonstration, that the standard will be at* 

tained and maintained in the following areas: 

(1) Areas in the vicinity of the followmg point sources of lead; 

Primary lead smelters. 

Secondary lead •neiten. -

Primary copper smelters. 

Lead tasodne additive plants. 

Lead arid storage battery, manufacturing 

plants that produce 2,000 or. more batteries 

per day. 

Any other stationary source that actually 

emits IS or more tons per year of lead or 

lead compounds fMMtutd ts elemental 

51.82 Air quality < 

51.83 Certain urbanised areas. 

5L84 -Areas around significant 

sources.' 

SL8S Other areas? 

51.86 Database*. 

51JT Measures 

MJ» Da-taawallabfltty. 

(2) Any other area-that haa lead ahconcentrations in exeeno f the nifi6nal standard oanwntraU<m for lead, 

measured atfcce January 1, \VtiSi-t 

(b) The, plan must demonstrate that 

the measures, rules, and regulations 

contained in the plan are p^^xnt^t-f to 

provide for the.atUlnment of tne national stoadapd for lead within the 

time prescribed by th * Act and for the 

ma tnteimngp aM-tat atandard for.a 

reaaona&f period thereafter. 

(c) The. plan must include the following: ,...• s^ydiJ, -r+A-- >-••••• •'.;>.: 

t W » AN T IWUlATrOHS 

(1) A summary of tbe computations, 

assumptions, and Judgments used to 

determine tbe reduction of emissions 

or reduction of the growth in emissions that wm result from the application of the control strategy. 

<3T A presentation of emission levels 

expected to result from apphcation of 

each measure of the control strategy. 

(3) A presentation of the air quality 

levels expected to result from application of the overall control strategy 

presented either in tabular form or as 

an Isopleth map showing expected 

maximum concentrations. 

161.81 Rmtosiooi data. 

(a) The plan must contam a summary of the baseline lead emission inventory based upon measured emissions or, where measured emissions 

are not available, documented emission factors. The point source inventory on which the summary is based 

must contain all sources that emit 5 or 

more tons of lead per year. The inventory must be summarized in a form 

similar to that shown in appendix D. 

(b) The plan must contain a summary of projected lead emissions for— 

(1) At least 3 years from the date by 

which EPA must approve or disapprove the plan if no extension under 

section 110(e) of the Clean Air Act is 

granted; 

(2) At least 5 years from the date by 

which EPA must approve or disapprove the plan if an extension is requested under section 110(e) of the 

Clean Air Act; or 

(3) Any other longer period lf required by the appropriate EPA Regional Administrator. 

(c) The plan must contain a description of the method used to project 

emissions. 

(d) The plan must contain an identification of the sources of the data 

used in the projection of emissions. 

§ 51.82 Air quality data. 

(a) The plan must contain a summary of all lead air quality data measured since January 1974. The plan 

must include an evaluation of the data 

for reliability, suitability for calibrating dispersion models (when such 

models wfll be used), and representativeness. When possible, the air quality (fata used must be for the same baseline year as for the emission inventory. 

(b) If additional lead air quality data 

are desired to determine lead air concentrations in areas suspected of exceeding the lead national ambient air 

quality standard, the plan may include 

data from any previously collected filters from particulate matter high 

vohane samplers. In determining the 

lead content of the fitters for control 

strategy demonstration purposes, a 

State may use, in addition to the refermethod. X-ray fluorescence or 

any other method approved by the Regional Administrator. r 

(c) The plan must also contain a tabulation of, or isopleth map showing, 

maximum air quality concentrations 

based upon projected emissions. 

§ 51.83 Certain urbanized areas. 

For urbanised areas with measured 

lead concentrations tn excess of 4 4 

fig/m', quarterly mean measured since 

January 1.1974, the plan must employ 

the modified rollback model for the 

demonstration of attainment as' a 

minimum, but may use an atmospheric 

dispersion model if desired. 

§51.84 Areas around significant poiat 

sources. 

(a) The plan must contain a calculation of the maximum lead air qualtty 

concentrations and the location of 

those concentrations resulting from 

the following point sources for the 

demonstration of attainment: 

Primary lead smelters. 

Secondary lead smelters. 

Primary copper smelters. 

Lead gasoline additive pi^ng 

Lead-add storage battery manufacturing 

plants that produce 2.000 or mere batteries 

per day. 

Any other stationary source that actually 

emits 25 or more tans per year of lead or 

lead wn-poundi meawiiwl as elemental 

lead. 

(b) In performing this analysis, the 

State shaD use an atmospheric dispersion modeL 

§51.85 Other areas. 

For each area in the vicinity of an 

air quality monitor that has recorded 

lead concentrations in excess of the 

lead national standard concentration, 

the plan must employ the modified 

rollback model as a minimum, but may 

use an atmospheric dispersion model if 

desired fbr the demonstration of attainment. 

§51.86 Databases. 

(a) For interstate regions, the analysis from each constituent State must, 

where practicable, be based upon the 

same regional emission inventory and 

air quality baseline. 

(b) Each State shall submit to the 

appropriate EPA Regional Office with 

the plan, but not as part of the plan, 

emissions data and information related to point and area source emissions 

as identified in the "Supplementary 

Guidelines for Lead Implementation 

Plans." 

(e) Air quality data. 

(1) Each State shall submit to the 

appropriate EPA Regional Office with 

the plan, but not as part of the plan, 

all lead air quality dato measured 

since January 1. 1974. Thia requlieV0L 4 * MO. m-THU*SDAY. OCfOM* % W » 

ry a*-.: "U?^..^'•'"• 

,.?•? •:-!:X'iV*(!w:r.a-. 

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IV 

ment does not apply if the data has already been submitted. 

(2) The data must be submitted in 

accordance with the procedures and 

data forms specified in chapter 3.4.0 of 

the "AEROS User's Manual" concerning storage and retrieval of aerometric 

date (SAROAD) except where the Regional Administrator waives this requirement. 

§ 51.87 Measures. 

(a) The lead control strategy must 

include the following: 

(1) A description of each control 

measure that is incorporated into the 

lead plan. 

(2) Copies of or citations to the enforceable laws and regulations to implement the measures adopted in the 

lead plan. 

(3) A description of the administrative procedures to be used in implementing each selected control measure. 

(4) A description of enforcement 

methods including, but not limited to, 

procedures for monitoring compliance 

with each of the selected control 

measures, procedures for handling violations, and a designation of agency responsibility for enforcement or implementation. 

§ 51.88 Data availability. 

(a) The State shall retain all detailed data and calculations used in 

the preparation of the lead analyses 

and plan, make them available for 

public inspection, and submit them to 

the Administrator at his request. 

(b) The detailed data and calculations used in the preparation of the 

lead analyses and control strategies 

are not considered a part of the lead 

plan. 

(Sees. 110. 301(a), Clean Air Act as amended 

(42 O.S.C. 7410, 7801).) 

[FR Doc. 78-28051 Filed 10-4-78; 8:45 am] 

I 

•?i£ft 

GQBCQA1, BEGISTBB, VOL 43, MO. 194—THUBS0AV, egffeKSl S,-J^l: 

•.« -

^U«Mili* M IMMMMUIIMI 
P.29 

[as ero Parfo si <=d &)j 

[PRL 987-71 

|te3O T AJQ (SOOTOQIN© QEFEaEWCG AK& 

G@yiVA(JiOT METHOOS FOQ LEAS 

NffiMso at Prepoood EUilocaoblng 

OENCY: Environmental Protection 

gency (EPA). 

CTION: Proposed rulemaking. 

UMMARY: On December 14, 1977, 

ew national primary and secondary 

mbient air quality standards for lead 

ere proposed (42 FR 63076). Atmosheric lead is proposed to be measured 

s elemental lead, either by the proceed reference method or "by an 

quivalent method." The amendments 

roposed below would provide the necBsary and appropriate changes in the 

xlsting equivalent method regulalons (primarily contained in 40 CFR 

'art 53) to allow the designation of 

quivalent methods for measuring atmospheric lead concentrations. 

>ATES: Comments relative to these 

iroposed regulations must be received 

iy November 20, 1978. 

1DDRESS: Send comments to Mr. 

•arry J. Purdue, Department E (MDS), Environmental Monitoring and 

Support Laboratory, U.S. Environmenal Protection Agency; Research Triingle Park, N.C. 27711. 

•"OR FURTHER INFORMATION 

CONTACT: 

Mr. Larry Purdue, telephone 919-

541-3076 (FTS 629-3076). 

Incidental information: The pro-

>osed reference method for measuring 

itmospheric lead, as well as much associated information, was published in 

he December 14, 1977, issue of the 

FEDERAL REGISTER (vol. 42), starting on 

jage 63076. 

SUPPLEMENTARY INFORMATION: 

BACKGROUND 

When the first national ambient air 

luallty standards were promulgated in 

.971 (36 FR 8186, Apr. 30, 1971), EPA 

:stablished the concept that measurenents of ambient air pollutants used 

a determine compliance with the 

standards must be made with either a 

specified "reference method" or with 

ui alternate method which could be 

ihown to be "equivalent" to the reference method. The air quality standards are now contained in part 50 of 

;itle 40 ofthe Code of Federal Regulations (40 CFR Part 50). Appendixes to 

part 50 specify either a prescribed ref-

:rence method, or a measurement 

principle and calibration procedure apra©p@§o® WM&§ 

plicable to reference methods, for 

each pollutant for which a standard 

has been promulgated. 

On February 18, 1975, EPA promulgated regulations to establish definitive requirements and procedures by 

which methods for measuring specified air poUutants may be designated 

"reference methods" or "equivalent 

methods" (40 FR 7044, Feb. 18. 1975). 

These regulations are contained in 40 

CFR Part 53. Originally these "equivalency" regulations were applicable 

only to methods for measuring SO,, 

CO, and photochemcial oxidants (O.), 

but were subsequently amended to 

cover methods for NO. as well (41 FR 

52692. Dec. 1, 1976). 

On December 14, 1977, EPA proposed amendments to 40 CFR Part 50 

to establish new national primary and 

secondary ambient air quality standards for lead. Also proposed was a new 

appendix to part 50 specifying a reference method for measuring atmospheric lead. The method proposed 

measures the lead content of suspended particulate matter collected on 

glass fiber filters using high volume 

samples. The lead is extracted from 

the particulate matter and measured 

by atomic absorption spectroscopy. 

The procedure proposed is necessarily 

very restrictive and specific in order to 

maintain the high level of accuracy 

and reproducibility and the low level 

of variability requisite for a reference 

method. However, other procedures 

are available for measuring lead which 

are likely to be as good as the reference method and may be advantageous to particular users. For example, 

using the same sampling procedure as 

the reference method (high volume 

sampler), several alternate analytical 

principles (flameless atomic absorption, optical emission spectrometry, 

and anodic stripping voltametry) are 

known to be suitable for lead analysis. 

If these alternate procedures can be 

designated as "equivalent" methods, 

then users would have much more 

flexibility in selecting a method for 

lead measurements which fits their 

own circumstances of available equipment, personnel, and expertise. 

Also, EPA sees no reason why lead 

measurements must be restricted to a 

particular sampling technique, such as 

the high volume sampler. For example, low volume particulate samples 

can be analyzed for lead by X-ray fluorescence. Other non-high-volume 

techniques may also be available or 

under development. By allowing for 

the possibility of qualifying such alternate methods as equivalent methods, 

EPA hopes to permit and encourage 

continued advancement in_ the technology of measuring atmospheric lead. 

For the reasons given above, EPA 

believes it is advantageous to propose 

appropriate amendments to 40 CFR 

Part 53 to extend the equivalent 

method regulations to cover methods 

for measuring lead ln the atmosphere. 

Since most, if not all, candidate equivalent methods for lead are likely to be 

manual methods, EPA expects relatively little initial Incentive for commercial organizations to apply for 

equivalent method determinations. 

Consequently, most equivalent 

method applications for lead methods 

will have to be originated by EPA 

under §53.7 "Testing of Methods at 

the Initiative of the Administrator." 

Specifically, EPA intends to pursue 

designation of some of the methods 

noted earlier, which are already in use 

among some monitoring agencies. 

These would include methods which 

use the same sampling procedure as 

the reference method, but use alternate analytical principles such as flameless atomic absorption, optical emission spectrometry, and anodic stripping voltametry. Direct analysis of 

high volume filters by X-ray fluorescence is also a likely candidate method 

for early designation by EPA. 

GENERAL APPROACH 

As suggested above, any method 

which purports to measure atmospheric lead could be considered as a candidate equivalent method, regardless of 

the sampling procedure or analytical 

technique used. To be designated as an 

equivalent method, the candidate 

method must demonstrate a "consistent relationship" to the reference 

method. This is done by taking simultaneous measurements with both 

methods in accordance with the procedures and requirements to be specified 

In 40 CFR Part 53. In addition, the 

candidate method must also demonstrate adequate precision among repeated analyses of the same sample. 

Since the proposed reference 

method provides 24-hour integrated 

measurements, candidate methods 

would have to be compared on that 

basis. Shorter term integrated methods or even automated methods could 

be considered as candidate methods. 

But only 24-hour averages could be 

compared to the reference method. 

Therefore, any subsequent designation 

of such a method as an equivalent 

method would apply only to 24-hour 

averages. 

AMENDMENTS TO 40 CFR PART 51 

Paragraph (a) of § 51.17a provides 

general requirements for air quality 

monitoring methods used by States in 

their implementation plan monitoring 

networks. Subparagraph (1) requires 

use of reference or equivalent methods 

for SO,, CO, O,, and NO., and would 

be amended to also include lead. Subparagraph (3) provides certain "grandfather" periods for use of existing 

methods for SO* CO, Ot. and NOo. It 

f_ 

PB33QAa C3@-3TKJ, VOL 03, NO. 194—TMUQSOAY, OCTOOGQ 9, 1970 

iirmrins 
P.30 

m* 

Ww>uld bs emended by adding a similar 

'^'grandfather" provision allowing existing methods for lead to be used 

until February 18, 1980—the same expiration date as that for existing 

method* for SOt, CO, and O,. 

AMENDMENT TO PART 53 

Subpart C of part 83 contains the 

test procedures prescribed for determining a consistent relationship between the reference method and a candidate equivalent method. Since these 

tests procedures were originally designed for gaseous pollutants, several 

significant changes and additions are 

required tp adapt the procedures for 

lead. 

DETERMINATION OF CONSISTENT 

RELATIONSHIP 

Section 53.30. paragraph (a) pertaining to the determination of a consistent relationship would be changed to 

indicate that the specifications for 

lead appear in a separate table (table 

C-3) than the specifications for SO,, 

CO, O,, and NO,. 

TEST SITE 

Section 53.30, paragraph (b), pertaining to test sites would be changed 

in several ways. First, the paragraph 

would be subdivided to differentiate 

the various requirements applicable 

to: (1) All methods, (2) methods for 

gaseous pollutants, and (3) methods 

for lead. Multiple test sites would be 

allowed for lead methods in order to 

facilitate measurements in the required range, since poUutant augmentation would not be feasible for particulate methods. Also, a new provision 

would allow an applicant to request 

approval of the test site or sites from 

EPA prior to conducting the tests. 

A final minor change proposed for 

paragraph (b) would delete the stipulation that test sites be away from large bodies of water ° ° °." This 

change has nothing to do with lead, 

but is prompted by general confusion 

among appUcants as to its specific 

meaning. Since the requirement is not 

essential, the current revision of the 

paragraph provides a good opportunity to eliminate both the stipulation 

and the confusion. 

OTHER GENERAL PROVISIONS 

Paragraphs (c), (d), and (e) of § 53.30 

would also be revised and reorganized 

to reflect the differences in requirements for methods for gaseous poUutants and for lead particulates. Revised 

paragraph (c) specifies the general requirement for simultaneous measurements at the test site in each of the required concentration ranges indicated 

by tables C-l or. C-3. Paragraph, (d) 

would be revised and subdivided to 

clarify the different requirements for 

sample coUection. Subparagraph (1) 

indicates the general requirement for 

homogenous samples. Subparagraph 

(2) specifies the use of a common distribution manifold and allows artificial 

poUutant augmentation for gaseous 

poUutants. Subparagraph (3) specifies 

the relative location requirements for 

lead samplers. And paragraph (4) 

would specificaUy allow the use of a 

common sample when the candidate 

method uses a sampling procedure 

identical to that of the reference 

method. Finally, the present paragraph (d) on "Submission of Test Data 

° ° °" would be changed to paragraph 

(e). 

<•» 

TEST CONDITIONS 

In §53.31 on "Test Conditions," 

paragraphs (a), (c), and (d) would be 

revised slightly to clarify certain differences between gaseous and particulate methods, and to clarify the requirements pertaining to calibration 

and range. 

TEST PROCEDURE 

Because the test procedures being 

proposed for lead differ considerably 

from those for gaseous pollutants, existing §53.32 would be retitled "Test 

Procedures for Gaseous PoUutants" 

and a new §53.33, "Test Procedures 

for Lead," would be added. The proposed new § 53.33 is simUar in form to 

§ 53.32, but the specific requirements 

for lead methods differ in several ways 

from the requirements for gaseous 

pollutant methods. First, a new table 

C-3 summarizes the test specifications 

pertinent to methods for lead. Only 

one concentration range is specified, 

into which five or more of the measurements must fail. The difference 

specification for lead is specified as a 

percent of the reference method measurement, as opposed to the fixed, absolute values specified for gaseous pollutant methods..An accuracy specification for the reference method based 

on analysis of audit samples supplied 

by EPA is specified. In addition, a performance specification for analytical 

precision is also being proposed to 

apply to lead methods. 

Because most methods for lead provide a result only after coUected samples are analyzed in a laboratory, the 

test acceptance criteria are based on a 

single sampling plan rather than the 

double sampling plan prescribed for 

gaseous pollutant methods. Ten or 

more (simultaneous) samples are collected and analyzed to provide at least 

five samples which faU into the required range of 0.5 to 4.0 ng/m'. Each 

sample is analyzed three times and the 

results of aU samples in the range are 

subjected to both the precision test 

prescribed in paragraph (e) and the 

consistent relationship test prescribed . 

in paragraph (f). For the candidate 

method to qusltfy fo? design&tSst&iCair 

test failures would be permitte^i@feithertest. '~~.cz- y" : 

PUBLIC PARTiciPATioEr 

Interested persons are invited to 

comment on any aspect of these gfc»* 

posed amendments. Comments shotsM 

be submitted in dupUcate and mds£'b& 

received by November 20. 1978. Address comments to Mr. Larry Purdue. 

Department E (MD-76), Environmental Monitoring and Support Laboratory, U.S. Environmental Protection 

Agency, Research Triangle.Park, N:C. 

27711. 

Dated: September 29,1978. 

DOUGLAS M. COSTLE, 

Administrator. 

It is proposed to amend chapter I, 

title 40, Code of Federal Regulations, 

as foUows: 

PAQT St—QEOUIQEA4EK178 FOQ PQEPAOATCOKI, 

ADOPTION, ANO SMQftOTTAa. OP VXW3S2&-

TATION PLANS 

1. In § 51.17a, paragraph (a) is 

amended by revising the first sentence 

of paragraph (a)(1) and adding a saatence to the end of paragraph (aX3) to 

read as foUows: J-.. 

§ 51.17a Air quality monitoring metteiScC 

(a) General requirements. (1) JEscept 

as otherwise provided in this paragraph (a), each method for measuring 

SO,, CO, O,, NO,, or lead used for pujr-* 

poses of § 51.17a shall be a referenda 

method or equivalent method as defined in § 53.1 of this chapter. ° ° ° 

(2) ° ° ° 

(3) ° ° ° Any manual method for 

lead in use before (date of promulgation of these amendments) may be 

used for purposes of § 51.17(a) untU 

February 18,1980. 

PART S3—AMBIENT AIQ MONITOQIN@ 

REFERENCE AND EOUIVALENT METHOOS 

2. In §53.30 the last sentence of 

paragraph (a) is deleted and new subparagraphs (1) and (2) are added; and 

paragraphs (b), (c), (d), and (e) are revised to read as foUows: 

§ 53.30 General provisions. 

(a) ° ° ° 

(1) A consistent relationship' is 

shown for SO,, CO, O,, and NOo methods when the differences between: (!) 

Measurements made by a candidate 

manual method or by'a test analyzer 

representative of a candidate automated method, and (ii) measurements 

made simultaneously by a reference. 

method are less than or equal to the 

value specified in the last column t& 

table C-l. - "-"•' 

(2) A consistent relatSdnah^ & / 

shown for lead methods when ths &$• 

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r

*£*"QFiyiji.j&**;*?.: 

; Hie same' 

fe 

j^gM*hod. and (11) 

' jrimattoneoqaiy 

less than 

tin Wale 

BgHutantn 

identified and 

•a an appropriate 

supporting evi-

_ MBNtatian densltraffte data, emtsnojlutant measure-

' y^ars, concurrent 

its, and wind or 

a request for 

test afte or sites may 

_ to, conducting the 

ptittainfetrstar may in his 

select a different site (or 

jMMttfcmAl tests he deiiy Methods for gaseous. poUutants. 

,'t$a£ measurements are to be made 

i'test attain If necessary, the 

rof pollutant tn the samja^&ptetttrsjir may be augmented 

iirtffida-fty generated pollutant to 

facflttate measurements to the speci-

(See paragraph (d)(2) of 

for lead. Test measuremade at any number of 

"Augmentation Of poUutant 

te not permitted, hence 

test site or sites must 

provide lead concentrapripettKed range. Test sites 

measurements must be be-

•6»wp%aad WO meters from the edge 

ei*Jieavlly traveled roadway. 

#;(«l;iTte»<-. at&ioephere. Ambient air 

,;i)fapled at an approriate test site shaU 

.loused for these tests. Simultaneous 

.-jitiftlgmtratian measurements shall be 

amide in each of the concentration 

_ rattanaspedfted In table C-l or table 

eoUection.—<i> AU methconcentrat-lon measureOf:

. aunples shall be taken in 

sr suchcAwayr.that both the candidate 

9-pd the reference method resamples that are-homogenous 

acasjirailKidfemtlcalwpractl^ --, 

for gd&oua poUutant*. 

b^aampled from a 

manlhomogenous 

lz^!r methods. Preeauaba)l be taken in the deafen and 

«. .jmntfjptlim afat-hte manifold to mini-

* -att^*vi. —Du^fi of particulates and 

'and to insure that identt-

-TMkc^jto two methods. If 

cfucentrattptt of pollut-

^.^•Rw-'^Bosampksd ambient air may be 

Zx-3mm&&'-iW aitifietaBy generated 

%rW88!9M^Mm**-M «tt ttm« the atr 

1 by the candidate and 

refcnmer methods under test ahall 

consist <tf not leas than 80 percent amMeat air by volume. Schematic drawDtty-rtsat aiBstraUons. deacripi^-aad complete details of the 

and the aagmentattoo system (tTused) shafl be submitted. - -

m MeOUxU for lead. The mtafce 

points of the candidate and reference 

•a-mpien for lead shall be located between S and 5 meters apart, and between 1.5 and 5 meters above ground 

level. 

(4) Methods employing a common 

sampling procedure. Candidate methods which employ a sampler and 

sample eoUection procedure which are 

identical to the sampler and sample 

colection procedure specified in the 

reference method may be tested by 

analysing common samples in accordance with the candidate and reference 

analysis procedures. The common 

samples are to be coUected according 

to the sample eoUection procedure 

specified by the reference method, and 

must be divided such that identical 

portions are analyzed by the analysis 

procedures of the two methods. 

(e) Submission of test data and other 

information. AU recorder charts, calibration data, records, test results, procedural descriptions and details, and 

other documentation obtained from 

(or pertinent to) these tests shaU be 

identified, dated, signed by the analyst 

performing the test, and submitted. 

3. In § 53.31, paragraphs (a), (c), and 

(dXl) are revised to read as follows: 

f 53.31 Test conditions. 

(a) AU methods. AU test measurements made or test samples coUected 

by means of a sample manifold as 

specified in § 53.30(d)(2) shall be at a 

room temperature between 20* and 30* 

C, and at a line voltage between 105 

and 125 volts. All methods shall be 

calibrated as specified in paragraph (e) 

of this section prior to initiation of the 

tests. 

(b) • • • 

(e) Calibration. The reference 

method shall be calibrated according 

to the appropriate appendix to part 50 

of: this chapter (if it is a manual 

method) or according to the applicable 

operation manual(s) (if it is an automated method). A candidate manual 

method (or portion thereof) shall be 

calibrated if such calibration is a part 

of the method. • * • 

(d> Range. (1) Except as provided to 

paragraph (d)(2) of this section; each 

method shall be operated in the range 

specified for the reference method in 

the appropriate appendix to part 50 

(for manual reference methods), or 

specified in table B-l of this part (for 

automated reference methods). 

-41, NO. 144—1HUUOAV, 

4. In §53.3*4, 

te revised t o read;. 

{514 2 Teat 

5. Section 53.33 is-added to read-** 

follow*:

 ::;-'"V • 

I53J3 Test 

(a) Sample caOeetlotu C-oOeet simultaneous 24-hour samples (fHtera) of 

lead at the test site or«8erwtthboth 

the reference and' candidate methods 

until at least 10 fOter patrs tisvehtien 

obtained. If the eondtttsne of 

§ 53.30(d)(4) apply, collect at least 10 

common samples (filters* In accordance with § 53.30(d)(4) and divide each 

to form the fUter pairs.! - •••'-_' --

(b) Audit samples. Ttereraadit aam- _. 

pies mustrtoe obtained franr tiie PhaiX 

tor. Environmental Manf-toring n d 

Support Laboratory. Department aE, 

UA Environmental<- iProtect-km 

Agency, Research Triangle E-ark, N.C. 

27711. The audit samples are "4x8 -

inch glass, fiber str^pf^containing 

known amounts of Wfcl at ttee following nominal levels: 100 -^tystUp; 300 

Mg/strip; 750 pg/ctrfe* .;*!»•»* teue--**,:^. 

amount of lead to total MS/attft will be-'*' '" 

provided wtth each aadn apsjptfc. 

(c) FUter analiifis. t^ Wtm; hoth tiie yA 

reference method and" taaeiaudlt aaa- J 

Ides, analyze each fitter^ «*fdj*»fi^;*>?~ 

times in accordance with_-^-wdj»»TOfle,7. 

method analytical. iuuw4ui^.'tt»:aa"; 

analysis of replicates ahottlda^not•!»-*/ 

performed sequfnttaUytl^ yprt rintlP 

sample should not be ada&Md thgto 

times in sequence). C&Iculage thelisdf--

cated lead concentratons for the reference method samples Ittpc/m*- lar 

each analysis of each fllterfe XJakHlate 

the indicated total lead aimxmtafor 

the audit samples in ^/-MTtoJ5or.eaj3i 

analysis of each strip. Lable *e»_tesl 

results as RIA> RIB. R,c RM^RSSI. '..'•>, 

Q-u. Q.B, Qio • • • -. where R denotes 

results from the reference, method 

samples; Q denotes results ft o the 

audit samples; 1, 2, 3 Indicates filter 

number and A. B, C indicates thefirst, 

second, and third analysis of each 

filter, respectively. 

(2) For the candidate method samples, analyze each sample filter or 

filter extract three Um«s>r:«nd calculate, in accordance with tJjjg candidate 

method, the indicated TttMraktQehtration in jig/m* for each analysts of eadi 

filter. Label these test. refiN^M-Cu. 

CIB> CM:, • where C denotes remirts 

from the candidate raetftddL (90rmt*~ 

dldate methods which- pro-rtfeardfceet 

measurement of lead- eMfljHftathi 

without a separable 

Ck-C^CoCu-Cw -

. (d) For the reference ,___r_T_ 

late the average lead^tbt«tf«M » 

each filter by averagm* pB^O*^fti. 

vm 
-!:- • 

pa®i?©SG® am®-*: 

Cans calculated from the three analyses: 

R

1A

 + R1B • R 

IC 

1 ave 

(e) Disregard aU filter pairs for 

which the lead concentration as determined in the previous paragraph (d) 

by the average of the three reference 

method determinations, falls outside 

the range of 0.5 to 4.0 jig/m». AU remaining filter pairs must be subjected 

to both of the foUowing tests for precision and consistent relationship. At 

least five filter pairs must be within 

where i 1s the filter number. 

the 0.5 to 4.0 fig/m' range for the tests 

to be valid. 

(f) Test for precision. (1) Calculate 

the precision (P) of the analysis (in 

percent) for each filter and for each 

method, as the maximum minus the 

minimum divided by the average of 

the three concentration values, as follows: 

R, max - R. min 

P

"

 = Ri R71vi xlOOt. orPc l 

C. max - C. min 

where i Indicates the filter number. 

(2) If any reference mthod precision 

value (PR,) exceeds 15 percent, the precision of the reference method analytical procedure is out of control. Corrective action must be taken to determine the source(s) of Imprecision and 

the reference method determinations 

must be repeated according to paragraph (c) of this-section, or the entire 

test procedure (starting with paragraph (a)) must be repeated. 

(3) If any candidate method precision value (Pw) exceeds 15 percent, the 

candidate method fails the precision 

test. 

(4) The candidate method passes 

this test if aU precision values (i.e., all 

Pw's and aU Pa's) are less than 15 percent. 

(g) Test for accuracy. (1) For the 

audit samples calculate the average 

lead concentration for each strip by 

averaging the concentrations calculated from the three analyses: 

Calculate the percent difference (D„) 

between the indicated lead concentration for each audit sample and the 

true lead concentration (T„) as foUows: 

Qi ave - T 

°qi

 = T. , 9 * 10° 

Qi ave = 

QiA * QiB * QiC, 

where i is audit-sample number. 

qi 

(2) If any difference value (D„) exceeds ±5 percent the accuracy of the 

reference method analytical procedure 

is out of control. Corrective action 

must be taken to determine the source 

of the errorts) (e.g., calibration standard discrepancies, extraction problems, 

etc.) and the reference method and 

audit sample determinations must be 

repeated according to paragraph (c) of 

this section or the entire test proce? 

dure (starting with paragraph (a)) 

must be repeated. 

(h) Test for consistent relationship. 

(1) For each filter pair, calculate all 

nine possible percent differences (D) 

between the reference and candidate 

methods, using all nine possible combinations of the three determinations 

(A, B, and C) for each method, as: 

Rik 

x 100%, where i is the filter number, and n 

'iff" 

numbers from 1 to 9 for the nine possible difference combinations for the 

three determinations for each method 

(j= A. B, C, candidate; k= A. B, C, reference). 

(2) If none of the percent differences 

(D) exceeds ±20 percent, the candidate method passes the test. 

(3) If one or more differences (D) exceeds ±20 percent, the candidate 

method falls the test for consistent relationship. 

(i) The candidate method must pass 

both the precision test and the consistent relationship test to qualify for designation as an equivalent method. 

TABEL C-3—TEST SPECIFICATIONS FOB LEAD 

METHODS 

Concentration range, ps/m'..... 

Minimum number of 34-hr measureMaximum analytical precision. percentMaximum analytical Accuracy, percent... 

Maximum difference, percent of reference method _. 

0.S to 4.0 

5 

13 

±3 

*20 

CFR Doc. 78-28052 Filed 10-4-78; 8:43 cm] 

(40-era Pars si] 

CFRL 937-81 

IMPUSfciUSOTATlON PLANS FOQ UA® 

MATtONAI. AMBIENT AIB QUAUTY STAMSAQ® 

Prepsood Qoquiroraon-to fe? Arablonf Ai? G-wslKy Ktoni-toring in tho Vicinity of Corteln load 

Pe>iirt Sourcoo; Advonco NoMco oi Prop«ood 

RidoQisMng 

AGENCY: Environmental Protection 

Agency. 

ACTION: Advance notice of proposed 

rulemaking. 

SUMMARY: This is an advance notice 

of EPA's intent to propose regulations 

that would require the State implementation plans (SIP's) for attainment and maintenance of the national 

ambient air quaUty standard (NAAQS) 

for lead to provide for the owner or 

operator of each primary or secondary 

lead smelter or primary copper smelter to establish a lead air quality monitoring system in the vicinity of the 

source and report the data to the 

State. EPA intends to propose this reqiurement partly in response to a comment received on the proposed lead 

implementation plan requirements of 

December 14. 1977 (42 FR 62087), but 

mainly as the initiation of a procedure 

for obtaining information concerning 

the nature, extent, and impact of fugitive lead emissions from the smelters 

since very little accurate information 

is currently avaUable. The intended 

effect of this requirement would be to 

obtain sufficient air quaUty data 

around the subject sources to determine if they are causing violations of 

the lead NAAQS. If violations are recorded, the States and EPA wiU determine whether additional or alternative 

control strategies would be adequate 

to attain and maintain the NAAQS for 

lead. 

DATES: Comments on this advance 

notice must be received on or before 

December 4, 1978. Comments submitted in duplicate will facUitate internal 

distribution and pubUc availability. 

ADDRESSES: Persons may submit 

written comments on this advance 

notice to: U.S. Environmental Protection Agency, Office of Air Quality 

Planning and Standards, Control Programs Development Division (MD 15), 

Research Triangle Park, N.C. 27711, 

attention: Mr. Joseph Sableski SPA 

will make all comments received on or. 

before December 4, 1978, available for 

pubUc inspection during normal business hours at: EPA Public Information 

Reference Unit, 401 M Street SW, 

Room 2922. Washington. D.C. 20490. 

FEE5QA!. QE61STGQ, VOL 43, KO. 1-34—TWJ380AV; eCT®a21 3, 1CTO 

VA-M * J 
FURTHER INFORMATION 

CONTACT: 

Mr. John SJIVESI, U.S. Environmental Protection Agency, Office of Air 

Quality Planning and Standards, 

Control Programs Development Division (ISD 19), Research Triangle 

Park, N.C. 27711, telephone: Commercial-010-541-5437; " FTS-629-

5437. 

SUPPLEMENTARY INFORMATION: 

BACKGROUND 

In another part of this FEDERAL REGISTER, EPA promulgated the national 

ambient air quaUty standards 

(NAAQS) for lead and requirements 

for the preparation, adoption, and submission of State implementation plans 

(SIP's) for the attainment and maintenance of those standards. Further information about the standards and the 

SIP's appears in those notices. 

States must now prepare and submit 

to EPA within 9 months SIP's that 

demonstrate that the NAAQS wiU be 

attained. In doing so, the States wiU 

have to quantify the lead emissions 

from sources and determine the effect 

of those einissions on the ambient air 

concentrations. For emissions that 

originate from stacks or tailpipes, the 

quantification can be done with a fair 

degree of accuracy. For emissions that 

originate from other than a primary 

exhaust system, such as through a 

plant's doors, windows, leaks in equipment, and so forth, the quantification 

is far more difficulat. Such emissions 

are commonly called fugitive emissions. Fugitive emissions are difficult 

to quantify accurately since they are 

dependent on a wide range of site-specific parameters, such as the lead content of the raw materials used in the 

process; number and size of open windows, doors and vent; wind speed and 

direction; rainfall; and so on—factors 

other than process throughput or production rates. 

Furthermore, there has not been 

much lead air quaUty data gathered 

around sources of these fugitive emissions. Also, there have never been any 

specific requirements in the regulations that apply to SIP's for requiring 

such data to be coUected around individual sources. Consequently, there is 

Uttle accurate Information concerning 

the amounts of fugitive emissions and 

the ambient air lead levels in the vicinity of sources of large amounts of lead 

emissions. EPA's assessments of the 

environmental and economic impacts 

of the lead NAAQS' 1,2 indicate that 

several categories of sources that emit 

predominantly fugitive lead emissions 

have the potential for the greatest air 

quaUty Impacts. The categories of concern are primary and secondary lead 

smelters and primary copper smelters. 

NATURE OP PROPOSAL 

EPA intends to propose regulations 

to enable the States and EPA to 

obtain an air quality data base needed. 

to determine compUance with the 

NAAQS' around sources in the abovementioned categories. The regulation 

would require the subject sources to 

establish an operate an air quality 

monitoring system in the vicinity of 

the sources. If the ambient data reveals tht concentrations are not as 

high as had originally been predicted 

when the State developed its initial 

lead SIP, and the source has not yet 

implemented the control caUed for in 

that SIP, the State may wish to revise 

its SIP to require less stringent control, thereby requiring a lesser burden 

on the source. Conversely, if the ambient data reveals that concentrations 

greater than the NAAQS occur after 

the control strategy in the SIP has 

been implemented, EPA could require 

the State to revise the SIP to require 

additional control of the sources. 

The regulations would require that 

the method of sample eoUection be 

the reference method as defined in 40 

CFR Part 50; this method ls the highvolume sampler. No other eoUection 

methods woud be allowed for monitoring in the vicinity of point sources, 

since it appears that other samplers 

would not sample the same quantity 

of larger particles that the highvolume sampler would coUect. The 

analysis method could be the reference method or an equivalent method 

as defined in 40 CFR Part 50. The 

sources would also have to obtain certain meteorological data to properly 

locate the samplers. 

EPA Intends to restrict this requirement only to primary and secondary 

lead smelters and primary copper 

smelters because EPA modeling studies (') of the six major lead point 

source categories (the other three 

being gasoline additive plants, leadacid battery manufacturing plants, 

and gray iron foundries) indicate that 

these three categories have a potential 

for an air quality impact that far esceeds that of the sources in the other 

categories. 

EPA would require the States to 

place the requirement for monitoring 

directly on the source owners and operators, using the authority of section 

114(a)(1)(C) of the Clean Air Act. This 

section authorizes the Administrator 

to require any source subject to a requirement of the Act to "° ° ° install, 

use, and maintain such monitoring 

equipment or methods ° ° c" The implementation plan would have to require the source owners or operators 

to periodicaUy report a summary of 

the data to the States and EPA. The 

data would then be used to determine 

whether a future plan revision Is indicated. 

The amount of ambient point source 

monitoring needed would vary and 

depend on the number of emission 

points at the source, the emission patterns, the topography, and the meteorology. EPA wiU develop a guidance 

manual on the number, siting, and operation of monitors around point 

sources. EPA estimates that the guidance will recommend that a network 

of about five samplers be placed in the 

vicinity of each source to which the 

regulation applies. States would have 

9 months after the promulgation of 

this requirement to revise their lead 

implementation plans to require the 

monitoring around the selected point 

sources. The sampling network would 

then have to be in place within 1 year 

after the date required for submission 

of the plan revision to account for this 

requirement if sufficient meteorological data were avaUable for use in siting 

the monitors. If the meteorological 

data were not avaUable, the source 

may have to coUect a year's worth of 

data before siting the air quality moni-" 

tors. 

EPA solicits comments on any issues 

concerning the intended proposed rulemaking and particuarly solicits comments on the foUowing topics: 

The need for the requirement for 

ambient monitoring in the vicinity of 

the lead point sources mentioned 

above or alternatives to this requirement that wiU accomplish the objective of obtaining more accurate data 

concerning these sources. 

Other sources around which EPA 

should require ambient monitoring. 

The criteria for the number, operation, and location of the samplers. 

The criteria for the length of period 

of each sampler, sampling frequency, 

and duration of the existence of the 

sampling system. 

Procedures for accounting for other 

sources in the vicinity of the source, 

including roadways. 

Procedures for accounting for complex topography. 

Procedures for accounting for meteorological conditions and obtaining 

meteorological data. 

Procedures for accounting for the 

nature and magnitude of fugitive emissions. 

Procedures for accounting for background concentrations. 

Procedures for accounting for source 

configuration. 

Procedures for reporting the coUected data to the State and EPA. 

The time aUowed for revision of the 

State implementation plan, to account 

for the requirement. 

r PGO&lAl QG-60STISQ, VOL 43, NO. 194—TWUQS9AV, OdTOIBSn 3, IWO 

a ai 
P.34 

? •' 

Sa. 

,Time allowed for compliance with 

tli» requirement contained in the implementation plan. 

Whether the burden of responslbUity should lie with the State agency or 

with the source. 

The cost to the States or the sources 

for compliance with these requirements. 

EPA intends to propose rulemaking 

on this matter by December 1978, and 

intends to make avaUable for public 

review at the same time a draft of the 

detailed guidance on ambient lead 

monitoring in the vicinity of lead 

point sources. 

FUGITIVE EMISSION FACTORS 

Also, EPA Intends to develop more 

accurate emission factors that relate 

the operation of a source to the 

amount of fugitie emissions the source 

generates. These factors wUI not be 

available, however, untU some time 

after the States must submit their implementation plans. Therefore, the 

States wiU have to rely on available 

fugitive emission factors to perform 

their air quality analyses In support of 

their implementation plans or develop 

their own factors based on any data 

that may be available, such as emission factors for total particulate 

PQOPOSE® BWMS& 

matter and information concerning 

the lead content of that particulate 

matter. 

Alternatively, States could develop 

their own emission factors based on 

field studies. There are several methods for doing this. (.3,4,5) 

After EPA develops emission factors 

for fugitive lead emissions. States 

could then determine whether their 

initiaUy developed plans require too 

much or too little control; they could 

then make any necessary adjustments 

to their implementation plans through 

revisions of those plans. The initial 

plan could require that sources phase 

in their control fairly slowly so that 

significant resources are not expended 

by the sources before EPA develops its 

fugitive emission factors. 

REFERENCES 

1. National Ambient Air Quality Standard 

for Lead: Final Draft: Environmental 

Impact Statement. U.S. Environmental Protection Agency, Office of Air and Waste 

Management, Office of Air Quality Planning and Standards, Research Triangle 

Park, N.C. July 1978. 

2. Economic Impact Assessment for the 

National Ambient Air Quality Standard for 

Lead and the Economic Implications of a 

Quarterly Mean Averaging Time for the 

Lead National Ambient Air Quality Standard. U.S. Environmental Protection Agency, 

4 0 ^ 

Office of Air and Waste Management, 

Office of Air Quality Planning and Standards, Rsearch Triangle Park. N.C. June 

1978. 

3. Technical Manual for the Measurement 

of Fugitive Emissions: Upwind-Downwind 

Sampling Method for Industrial Fugitive 

Emissions. U.S. Environmental Protection 

Agency, Industrial and Environmental Research Laboratory, Research Triangle Park. 

N.C. April 1976. Publication No. EPA-800/1-

76-089a. 

4. Technical Manual for the Measurement 

of Fugitive Emissions: Roof Monitor Sampling Method for Industrial Fugitive Emissions. U.S. Environmental Protection 

Agency, Industrial and Environmental Research Laboratory, Research Trtange Park, 

N.C. May 1976. Publication No. EPA-600/2-

76-089b. 

5. Technical Manual for Measurement of 

Fugitive Emissions: Quasi-Stack Sampling 

Method for Industrial Fugitive Emissions. 

U.S. Environmental Protection Agency, Industrial and Environmental Research Laboratory, Research Triangle Park, N.C. May 

1976. Publication No. EPA-600/a-76-089c. 

(Sees. UO, 114(a)(1), and 301(a) of the Clean 

Air Act as amended (42 U.S.C. 7410. 7417. 

and 7601).) 

Dated: September 29,1978. 

DOUGLAS M. COSTLE, 

Administrator. 

CFR Doc. 78-28053 Filed 10-4-78; 8:45 ami 

fr.. 

'%•, 

FEDSQAl aECISTEB, VOL 43, NO. 194—TMU0S9AY, 000(320 3, 1970 

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