[Federal Register Volume 64, Number 9 (Thursday, January 14, 1999)]
[Proposed Rules]
[Pages 2538-2544]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-893]



[[Page 2537]]

_______________________________________________________________________

Part II





Environmental Protection Agency





_______________________________________________________________________



40 CFR Part 141



National Primary Drinking Water Regulations: Analytical Methods for 
Microbes, Lead, and Magnesium; Proposed Rule

  Federal Register / Vol. 64, No. 9 / Thursday, January 14, 1999 / 
Proposed Rules  

[[Page 2538]]



ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 141

[WH-FRL-6218-7]


National Primary Drinking Water Regulations: Analytical Methods 
for Microbes, Lead, and Magnesium

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: On July 31, 1998, EPA proposed changes relating to analytical 
test methods for the measurement of total coliforms, Escherichia coli, 
and pesticides (63 FR 41134). Consistent with that proposal, the Agency 
is proposing to approve two new analytical methods, the E*Colite test 
and ColiBlue24 test, as options for detecting total coliforms and E. 
coli in drinking water. Both organisms must be monitored under EPA's 
drinking water regulations on total coliforms. In addition, the Agency 
is also proposing to approve a new lead method. By today's action, EPA 
is making available to the public studies that demonstrate that these 
three methods are at least as good as EPA's previously approved methods 
for detecting total coliform bacteria and E. coli, and lead, in 
drinking water. The Agency evaluated data on the two coliform methods 
and one lead method and found them to be at least as good as EPA's 
``reference'' methods.
    In addition to these three tests, the Agency proposes six 
analytical methods for magnesium. This action compensates for an 
omission in the Stage 1 Disinfectants and Disinfection Byproducts (DBP) 
Rule, which was promulgated on November 30, 1998. The DBP Rule allows 
certain surface water systems that are unable to achieve the specified 
level of total organic carbon removal to meet instead one of several 
alternative performance criteria, including the removal of 10 mg/L 
magnesium hardness from source water. The rule, however, does not 
include any analytical methods for magnesium.
    EPA invites public comment on whether the Agency should approve the 
E*Colite test and ColiBlue24 test for total coliforms and E. coli, the 
lead method, and the six magnesium methods.

DATES: Written comments should be postmarked, delivered by hand, or 
electronically mailed on or before March 1, 1999.

ADDRESSES: Any person may submit written or electronic comments on 
these new data supporting the earlier proposed rule, described below. 
Written comments may be sent to the W-98-27 Drinking Water Analytical 
Methods Clerk, U.S. Environmental Protection Agency, Water Docket, MC 
4101, 401 M Street, SW, Washington, DC 20460. EPA would appreciate an 
original and 3 copies of your comments and enclosures (including 
references, if cited). Commenters should use a separate paragraph for 
each method or issue discussed. No facsimiles (faxes) will be accepted 
because EPA cannot ensure their submission to the Water Docket. 
Commenters who would like acknowledgment of receipt of their comments 
should include a self-addressed, stamped envelope.
    Electronic comments should be sent to the Internet address: ow-
[email protected]. Avoid use of special characters and any form of 
encryption. EPA will attempt to clarify electronic comments if a 
transmission error occurs. Comments provided electronically will be 
considered timely if they are submitted electronically by 11:59 p.m. 
(Eastern time) on March 1, 1999. Commenters may also provide disks. If 
comments are sent via the Internet or on disks, they must be formatted 
in WordPerfect 5.1 or 6.1, or ASCII, and identified by the docket 
number W-98-27. A printout of the electronic comments will be filed for 
the official record.
    The record for this rulemaking has been established under docket 
number W-98-27. Copies of the supporting documents (including 
references and methods cited in this document) are available for review 
at the U.S. Environmental Protection Agency, Water Docket, EB 57, 401 M 
Street, SW, Washington, DC 20460. For access to the docket materials, 
call 202-260-3027 on Monday through Friday, excluding Federal holidays, 
between 9 a.m. and 3:30 p.m. Eastern Time for an appointment. Today's 
Federal Register document has been placed on the Internet for public 
review and downloading at the following location: http://www.epa.gov/
fedrgstr.

FOR FURTHER INFORMATION CONTACT: EPA Safe Drinking Water Hotline, for 
general information. Callers within the United States may reach the 
Hotline at 800-426-4791. The Hotline is open Monday through Friday, 
excluding Federal holidays, from 9 a.m. to 5:30 p.m. Eastern Time.
    For technical information regarding microbiology methods, contact 
Paul S. Berger, Ph.D., Office of Ground Water and Drinking Water (MC-
4607), U.S. Environmental Protection Agency, Washington, DC 20460, 
telephone 202-260-3039. For technical information regarding chemistry 
methods, contact Dan Schmelling, Office of Ground Water and Drinking 
Water (MC-4607), U.S. Environmental Protection Agency, Washington, DC 
20460, telephone 202-260-1439.

SUPPLEMENTARY INFORMATION:

I. Regulated Entities

    Entities potentially regulated by this action are listed below:

------------------------------------------------------------------------
           Category                  Example of regulated entities
------------------------------------------------------------------------
Industry.....................  (1) All water systems that serve at least
                                25 year-round residents or have at least
                                15 service connections used by year-
                                round residents (Community water
                                system).
                               (2) All water systems that regularly
                                serve at least 25 of the same persons
                                over 6 months per year, but not year-
                                round (Non-transient, non-community
                                water system).
                               (3) All water systems that serve at least
                                25 people daily for at least 60 days
                                during a year, but less than 6 months
                                (Transient, non-community water
                                systems).
State, Local, and Tribal       Same as above.
 Governments.
Federal Government...........  Same as above.
------------------------------------------------------------------------

    This table is not intended to be exhaustive, but rather provides a 
guide for readers regarding entities likely to be regulated by this 
action. This table lists the types of entities that EPA is now aware 
could potentially be regulated by this action. Other types of entities 
not listed in the table could also be regulated. To determine whether 
your facility is regulated by this action, you should carefully examine 
the applicability of current drinking water standards and monitoring 
requirements in Sec. 141.21 for coliforms and Sec. 141.80 for lead of 
title 40 of the Code of Federal Regulations, and Sec. 141.135(a)(3) of 
the Federal Register for the Stage 1 DBP Rule. If you have questions 
regarding

[[Page 2539]]

the applicability of this action to a particular entity, consult one of 
the persons listed in the FOR FURTHER INFORMATION CONTACT section.

II. Explanation of Today's Actions

    On July 31, 1998, EPA proposed to approve analytical methods for 
several pesticides and microbial contaminants (total coliforms and E. 
coli) for compliance with the maximum contaminant levels for these 
contaminants under the Safe Drinking Water Act at 63 FR 41134. Today's 
proposed rule would approve two additional methods for total coliforms 
and E. coli, and one additional method for lead. If approved, 
laboratories may either use these tests or any other EPA-approved test 
for total coliforms or E. coli, and lead, in drinking water.
    In addition, on July 29, 1994, the Agency proposed the Stage 1 DBP 
Rule at 59 FR 38668, and promulgated the rule on November 30, 1998. The 
DBP Rule requires subpart H systems (public water systems covered by 
EPA's Surface Water Treatment Rule) that use conventional treatment to 
remove total organic carbon (TOC) by enhanced coagulation or enhanced 
softening. For systems practicing enhanced softening that cannot 
achieve the specified level of TOC removal, the rule allows such 
systems to meet instead one of several alternative performance 
criteria, including the removal of 10 mg/L magnesium hardness (as 
CaCO3) from the source water. Analytical methods for TOC 
were described in the proposed rule and a subsequent NODA at 62 FR 
59388 (Nov. 3, 1997). However, the rule omitted analytical test methods 
for magnesium. Today's proposed rule compensates for this omission by 
identifying several such methods for magnesium and providing an 
opportunity for comment. For all methods in today's proposal, the 
Agency intends to seek approval from the Office of the Federal Register 
in order to incorporate the methods by reference in the final rule.
    On October 6, 1997, EPA published a notice of the Agency's intent 
to implement a Performance Based Measurement System (PBMS) in all of 
its programs to the extent feasible (62 FR 52098). The Agency is 
currently determining the specific steps necessary to implement PBMS in 
its programs and preparing an implementation plan. As part of this 
process, EPA is currently evaluating what relevant performance 
characteristics should be specified for monitoring methods used in the 
water programs under a PBMS approach to ensure adequate data quality. 
EPA would then specify performance requirements in its regulations to 
ensure that any method used for determination of a regulated analyte is 
at least equivalent to the performance achieved by other currently 
approved methods. EPA expects to publish its PBMS implementation 
strategy for water programs in the Federal Register in the early 
calendar year 1999.
    Once EPA has made its final determinations regarding implementation 
of PBMS in programs under the Safe Drinking Water Act, EPA would 
incorporate specific provisions of PBMS into its regulations, which may 
include specification of the performance characteristics for 
measurement of regulated contaminants in the drinking water program 
regulations. In addition to requesting comment on the methods described 
below, EPA is also seeking comment on the application of PBMS in its 
Drinking Water program and on the establishment of performance 
characteristics for the methods addressed in this document.

1. Methods for Total Coliforms and E. coli

    EPA is proposing to approve the following total coliform/ E. coli 
methods that would be used for demonstrating compliance with the Total 
Coliform Rule.
a. E*Colite Test
    The E*Colite test simultaneously determines the presence of total 
coliforms and E. coli, both of which must be monitored under the Total 
Coliform Rule at 40 CFR 141.21. The E*Colite test involves a dehydrated 
medium to which a 100-mL water sample is added. The test consists of a 
packaged sterile burst-a-seal bag divided into three compartments. The 
upper compartment is used for sample collection and optionally contains 
a sodium thiosulfate tablet to eliminate free chlorine and/or bromine 
in the water. The middle compartment of the bag contains the medium for 
growth and enzyme substrates for detection of total coliforms and E. 
coli. The lower compartment optionally holds a bactericide (a 
quaternary amine) that the analyst can introduce to kill the grown 
coliforms.
    First, a 100-mL water sample is added to the upper compartment and 
the bag sealed. Then the water sample is pushed through the burst-a-
seal into the medium, and the two are mixed. The bag is then incubated 
for 28 hours at 35 deg.C (the bag may first need to be placed in a 
35 deg.C water bath for 10 minutes to bring the sample up to incubation 
temperature quickly). After incubation, the bag is observed for the 
presence of a blue/green color. If present, the sample is total 
coliform-positive. If the blue/green color is also fluorescent under an 
ultraviolet light (366 nm), the sample is E. coli-positive. If the 
blue/green sample does not fluoresce after 28 hours, the sample should 
be incubated an additional 20 hours (total 48 hours of incubation), and 
checked again for fluorescence.
    The E*Colite test is based on the detection of two enzymes: beta-D-
galactosidase and beta-D-glucuronidase, which are characteristic of the 
total coliform group and E. coli, respectively. Coliforms produce beta-
D-galactosidase, which hydrolyzes X-GAL in the medium to produce a blue 
chromogen. E. coli produces beta-D-glucuronidase, which hydrolyzes 4-
methylumbelliferyl-beta-D-glucuronide (MUG) in the medium that releases 
a fluorescent compound.
    EPA has statistically evaluated comparability data submitted by the 
manufacturer, and has determined that results obtained with the 
E*Colite test are not statistically different from the Agency's 
reference method for total coliforms and E. coli. The manufacturer 
observed a false-positive error of 16.0% and 7.2% for total coliforms 
and E. coli, respectively. The false-negative rate, respectively, was 
3.7% and 9.2%. Based on these results, EPA believes that the E*Colite 
test is satisfactory as a compliance method for total coliforms and E. 
coli.
    The method description for E*Colite test is available from Charm 
Sciences, Inc., 36 Franklin Street, Malden, MA 02148-4120. Their 
telephone number is (781) 322-1523. This information is also available 
in the docket for today's document.
b. ColiBlue24 Test
    The ColiBlue24 test is a membrane filtration method that 
simultaneously determines the presence or absence of total coliforms 
and E. coli, both of which must be monitored under the Total Coliform 
Rule (40 CFR 141.21). The test involves filtering a 100-mL drinking 
water sample through a 47-mm membrane filter which is transferred to a 
50-mm petri plate containing an absorbent pad saturated with M-
ColiBlue24 Broth. After incubation at 35 deg.C for 222 
hours, the membrane is examined for colony growth. The presence of 
total coliforms is indicated by red colonies; if E. coli is also 
present, blue colonies will be observed.
    M-ColiBlue24 Broth is a nutritive lactose-based medium containing 
inhibitors to eliminate growth of non-coliforms. Total coliform 
colonies growing on the medium are identified

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by a nonselective dye, 2,3,5-triphenoltetrazolium chloride (TCC), which 
produces red colonies. The selective identification of E. coli is based 
on the detection of the beta-glucuronidase enzyme. The test medium 
includes the chromogen 5-bromo-4-chloro-3-indoxyl-beta-D-glucuronide 
(BCIG) which is hydrolyzed by the enzyme, releasing an insoluble 
indoxyl salt that produces blue colonies.
    EPA has statistically evaluated comparability data submitted by the 
manufacturer, and has determined that the ColiBlue24 test is not 
statistically different from the Agency's reference method for total 
coliforms and E. coli. With regard to specificity, 25 different water 
samples from seven different geographical locations were analyzed for 
total coliforms and E. coli by the ColiBlue24 test and the reference 
methods. Positive and negative cultures were then validated by standard 
tests. These results indicated that ColiBlue24 had a false positive 
rate of 26.8% and 2.5% for total coliforms and E. coli, respectively. 
The false negative rate was 1.6% and 0%, respectively. Using M-Endo LES 
as a comparison to M-ColiBlue24 for total coliform specificity, the M-
Endo false positive error was 29.6% and the undetected target error was 
3.4%. EPA believes that these results show that the specificity of the 
ColiBlue24 test for total coliforms and E. coli is reasonable.
    With regard to performance comparability, investigators analyzed 10 
samples spiked with wastewater from 10 different sites and compared the 
ColiBlue24 method with EPA's reference methods for the detection of 
chlorine-injured total coliforms and E. coli. The results indicate that 
detection of total coliforms and E. coli by ColiBlue24 does not differ 
significantly from the standard method and that this conclusion is 
consistent across all samples. After 24 hours, the ColiBlue24 test had 
an average of 1.07 times more total coliform-positive responses than 
the reference method and 1.01 times more E. coli-positive responses 
than the reference method. This study suggests that the ColiBlue24 test 
could recover chlorine-injured coliforms as well as EPA's reference 
methods. The above studies suggest that the ColiBlue24 test performs 
satisfactorily and its performance is at least as good as the reference 
methods for total coliforms and E. coli.
    The method description for ColiBlue24 Test is available from the 
Hach Company, 100 Dayton Avenue, Ames, IA 50010. Their telephone number 
is (515) 232-2533. Of course, this information is also available in the 
docket for today's document.

2. Magnesium Tests

    Today's notice proposes to approve six magnesium methods, which are 
grouped into the following three analytical techniques. These methods 
would be used to demonstrate compliance with the treatment requirements 
of the Stage 1 DBP Rule.
a. Atomic Absorption (AA) Spectrophotometric Methods ((Standard Method 
3500-Mg B (APHA, 1995) and ASTM D 511-93 B (ASTM, 1998))
    In the measurement of magnesium by atomic absorption spectrometry, 
a sample is aspirated into a flame and atomized. Addition of 
interference-suppressing agents may be necessary. A light beam is 
directed through the flame, into a filter or monochromator set at 285.2 
nm, and onto a detector which determines the light absorbed by the 
magnesium. The concentration of magnesium is proportional to absorbance 
within the linear range of the instrument. These methods are generally 
applicable to magnesium concentrations in the range 0.02-3.0 mg/L, 
depending on the instrument and method employed. Higher concentrations 
may be analyzed by dilution of the sample prior to analysis.
b. Inductively Coupled Plasma (ICP) Methods ((Standard Method 3500-Mg C 
(APHA, 1995) and EPA Method 200.7 (EPA, 1994))
    An ICP source consists of a stream of argon gas ionized by an 
applied radio frequency field. This field is inductively coupled to the 
ionized gas by a coil surrounding a quartz torch that supports and 
confines the plasma. Analysis of magnesium by ICP involves generation 
of a sample aerosol in a nebulizer and subsequent injection into the 
ICP. This subjects the constituent atoms to temperatures of 6000 to 
8000  deg.K, resulting in almost complete dissociation of molecules and 
excitation of atomic emission. A portion of the emission spectrum 
(usually 279.08 or 279.55 nm for magnesium) from the ICP is isolated 
for intensity measurement. The efficient excitation provided by the ICP 
results in low detection limits and the linear range of the instrument 
may span four orders of magnitude (APHA 1995).
c. Complexation Titrametric Methods (Standard Method 3500-Mg E (APHA 
1995) and ASTM D 511-93 A (ASTM 1998))
    These methods measure magnesium as the difference between hardness 
(equal to calcium plus magnesium) and calcium. Hardness is measured by 
titration of a sample with EDTA (ethylenediamine tetraacetic acid)at pH 
10. Calcium is determined by titration of a separate aliquot of sample 
with EDTA at a pH of 12-13, where the magnesium is precipitated. A 
chemical indicator is added to the sample to allow observation of the 
endpoint. These methods are generally applicable in a range from 1 to 
1000 mg/L of calcium plus magnesium expressed as calcium, but may fail 
in the analysis of highly colored waters or waters that contain high 
concentrations of metals (ASTM, 1998).

3. Test for Lead

    Today's notice proposes the following lead method that would be 
used for demonstrating compliance with the monitoring requirement for 
lead in 40 CFR 141.89.
Method 1001: Lead in Drinking Water Differential Pulse Aniodic 
Stripping Voltammetry (DPAV)
    This method is for the determination of dissolved and total 
recoverable lead in drinking water. For dissolved lead, a 125-mL sample 
is collected, passed through a 0.45 m filter, and acidified to 
pH<2 prior to shipment to the laboratory. For total recoverable lead, 
the sample is acidified to pH<2 prior to shipment to the laboratory. 
Samples for total recoverable lead must be acid-digested before 
analysis. In either case (dissolved or total recoverable lead), A 50-mL 
aliquot of acid-preserved or acid-digested sample is neutralized with 
sodium hydroxide. A 5-mL portion of the neutralized sample is decanted 
to a sample tube, buffered to pH 4, and conditioned with an excess of 
supporting electrolyte to ensure the precision of the analysis. Then a 
decomplexing agent is added to release lead from polyphosphate 
complexes.
    The lead in the conditioned sample is determined by DPAV using a 
precalibrated disposable sensor. The lead in the sample is concentrated 
by plating onto the working electrode of the disposable sensor and then 
it is stripped back into solution by raising the electrode potential. 
As the lead returns to solution, a peak of current is detected. The 
peak potential identifies the metal and the peak height is proportional 
to the concentration of the lead. The peak height is converted to 
micrograms per liter of lead by reference to calibration curves in the 
instrument software. Quality is assured through calibration and 
verification with external referenced standard solutions.

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    EPA has statistically evaluated comparability data submitted by the 
manufacturer, and has determined that the results using the DPAV method 
described above are not statistically different from the Agency's 
reference methods for lead (without sample compositing). The 
manufacturer observed a method detection limit of 2 g/L lead. 
The standard deviation of replicate observations (n=10) of a 
calibration standard containing 15 g/L lead was 0.75 
g/L. With multiple batches of tablet reagents and sensors, the 
relative standard deviation of sets of observations (n=10) containing 
15 g/L lead varied from 2.1 to 3.8%. A drinking water sample initially 
containing 8 g/L lead, was fortified to a total concentration 
of 48 g/L. The mean percent recovery of the added 40 g/L lead 
was 110% and the corresponding standard deviation of the percent 
recoveries of multiple analyses was 1.5%. Similar recoveries were 
obtained from other drinking water matrices.
    The description for Method 1001 for Lead in Drinking Water 
Differential Pulse Aniodic Stripping Voltammetry is available from 
Palintest LTD, 21 Kenton Lands Road, PO Box 18395, Erlanger, KY 41018. 
The telephone number is (606) 341-7423.

II. Regulation Assessment Requirements

A. Executive Order 12866

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), the 
Agency must determine whether the regulatory action is ``significant'' 
and therefore subject to OMB review and the requirements of the 
Executive Order. The Order defines ``significant regulatory action'' as 
one that is likely to result in a rule that may:
    (1) Have an annual effect on the economy of $100 million or more, 
or adversely affect in a material way the economy, a sector of the 
economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities;
    (2) Create a serious inconsistency or otherwise interfere with an 
action taken or planned by another agency;
    (3) Materially alter the budgetary impact of entitlements, grants, 
user fees, or loan programs or the rights and obligations of recipients 
thereof; or
    (4) Raise novel legal or policy issues arising out of legal 
mandates, the President's priorities, or the principles set forth in 
the Executive Order.
    It has been determined that today's proposal is not a ``significant 
regulatory action'' under the terms of Executive Order 12866 and is 
therefore not subject to OMB review.

B. Regulatory Flexibility Act (RFA)

    Under the Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., 
as amended by SBREFA, EPA generally is required to conduct a regulatory 
flexibility analysis describing the impact of the regulatory action on 
small entities as part of rulemaking. However, under section 605(b) of 
the RFA, if EPA certifies that the rule will not have a significant 
economic impact on a substantial number of small entities, EPA is not 
required to prepare a regulatory flexibility analysis.
    The Small Business Administration (SBA) defines a small business as 
50,000 or less. However, the RFA allows an Agency to use an alternative 
definition of ``small'' if that Agency has consulted with the SBA on 
the alternative definition and has proposed the alternative in the 
Federal Register and taken public comment. EPA defines small entities 
as those public water systems serving 10,000 or fewer customers. In 
accordance with the RFA requirements, EPA consulted with the SBA on 
this definition and proposed the definition in the Federal Register (63 
FR 7620-7621; February 13, 1998). EPA finalized this definition in the 
final Consumer Confidence Report regulation on August 19, 1998 (63 FR 
44524-44525).
    This proposed rule would provide public water systems additional 
options for detecting total coliforms and E. coli under the Total 
Coliform Rule and for measuring lead under the Lead and Copper rule. It 
would also allow certain systems using softening to analyze for 
magnesium under the DBP Rule, if they are unable to meet the the 
specified level of total organic carbon removal. The rule would not 
impose additional requirements. Therefore, pursuant to section 605(b) 
of the RFA, 5 U.S.C. 605(b), the Agency certifies that this proposal 
would not have a significant economic impact on a substantial number of 
small entities.

C. Unfunded Mandates Reform Act

    Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub. 
L. 104-4, establishes requirements for Federal agencies to assess the 
effects of their regulatory actions on State, local, and tribal 
governments and the private sector. Under section 202 of the UMRA, EPA 
generally must prepare a written statement, including a cost-benefit 
analysis, for proposed and final rules with ``Federal mandates'' that 
may result in expenditures to State, local, and tribal governments, in 
the aggregate, or to the private sector, of $100 million or more in any 
one year. Before promulgating an EPA rule for which a written statement 
is needed, section 205 of the UMRA generally requires EPA to identify 
and consider a reasonable number of regulatory alternatives and adopt 
the least costly, most cost-effective or least burdensome alternative 
that achieves the objectives of the rule. The provisions of section 205 
do not apply when they are inconsistent with applicable law. Moreover, 
section 205 allows EPA to adopt an alternative other than the least 
costly, most cost-effective or least burdensome alternative if the 
Administrator publishes with the final rule an explanation why that 
alternative was not adopted.
    In addition, before EPA establishes any regulatory requirements 
that may significantly or uniquely affect small governments, including 
tribal governments, it must have developed under section 203 of the 
UMRA a small government agency plan. The plan must provide for 
notifying potentially affected small governments, enabling officials of 
affected small governments to have meaningful and timely input in the 
development of EPA regulatory proposals with significant Federal 
intergovernmental mandates, and informing, educating, and advising 
small governments on compliance with the regulatory requirements.
    Today's rule contains no Federal mandate under the regulatory 
provisions of Title II of the UMRA, because it would impose no 
enforceable ``duty'' on any State, local, or tribal governments or the 
private sector. Moreover, the rule would not contain any Federal 
mandate that would result in expenditures of $100 million or more by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, in any one year. The rule would merely approve use of 
additional analytical methods for total coliforms and E. coli under the 
Total Coliform Rule and an additional method for lead under the Lead 
and Copper Rule. Systems would be able to choose between already 
approved methods for total coliforms/E. coli and lead and the new 
methods. The proposed rule would also approve six methods for magnesium 
under the Stage 1 DBP Rule, allowing certain systems using softening 
that are unable to meet the specified level of total organic carbon 
removal to analyze for magnesium instead. EPA estimates that the cost 
of a magnesium analysis should not exceed $20 per sample; systems 
analyzing magnesium under the DBP Rule would be required to collect 24 
samples per year, which would cost no more than $20  x  24= $480 per 
year. EPA

[[Page 2542]]

believes that less than 1% of the 1,395 surface water systems covered 
by the DBP Rule will choose to monitor for magnesium. Therefore, 
today's proposal is not subject to the requirements of sections 202 and 
205 of the UMRA. In addition, this action contains no regulatory 
requirements that might significantly or uniquely affect small 
governments. Therefore, it is not subject to section 203 of the UMRA.

D. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995, 44 
U.S.C.3501 et seq., EPA must submit an information collection request 
covering information collection requirements in a rule to the Office of 
Management and Budget for review and approval. This proposed rulemaking 
does not contain any information collection requirements, and therefore 
is not covered under the Paperwork Reduction Act. Therefore, 
preparation of an information collection request to accompany this 
document is unnecessary.

E. Science Advisory Board and National Drinking Water Advisory Council, 
and Secretary of Health and Human Services

    In accordance with section 1412 (d) and (e) of the SDWA, the Agency 
is submitting this proposal to the Science Advisory Board, the National 
Drinking Water Advisory Council, and the Secretary of Health and Human 
Services for their review.

F. National Technology Transfer and Advancement Act (NTTAA)

    Under section 12(d) of the NTTAA, the Agency is required to use 
voluntary consensus standards in its regulatory activities unless to do 
so would be inconsistent with applicable law or otherwise impractical. 
Voluntary consensus standards are technical standards (e.g., material 
specifications, test methods, sampling procedures, business practices, 
etc.) that are developed or adopted by voluntary consensus standard 
bodies. Where available and potentially applicable voluntary consensus 
standards are not used by EPA, the Act requires the Agency to provide 
Congress, through OMB, an explanation for the reasons for not using 
such standards.
    In preparing today's proposed rule, EPA searched for consensus 
methods that would be acceptable for compliance determinations under 
the SDWA for the measurement of magnesium. EPA is proposing use of 
magnesium testing protocols in Standard Methods for the Examination of 
Water and Wastewater and ASTM because they are highly respected and 
widely used consensus references. By providing notice of the Agency's 
intention to approve these methods, the Agency also acts consistent 
with provisions of the NTTAA. This notice also is proposing to approve 
two new methods for detection of total coliforms and E. coli, and one 
method for lead, which are not yet consensus methods. However, EPA has 
previously approved consensus methods for coliforms and E. coli and 
lead, and the three new methods will be considered for incorporation 
into Standard Methods for the Examination of Water and Wastewater. EPA 
invites comments on the potential use of voluntary consensus standards 
in this notice, as well as identification and information about other 
voluntary consensus standards that the Agency could consider for the 
analysis of total coliforms, E. coli, lead, and magnesium under the 
SDWA.

G. Executive Order 13045--Protection of Children From Environmental 
Health Risks and Safety Risks

    Executive Order 13045 applies to any rule that: (1) Is determined 
to be ``economically significant'' as defined under E.O. 12866, and (2) 
concerns an environmental health or safety risk that EPA has reason to 
believe may have a disproportionate effect on children. If the 
regulatory action meets both criteria, the Agency must evaluate the 
environmental health or safety effects of the planned rule on children, 
and explain why the planned regulation is preferable to other 
potentially effective and reasonably feasible alternatives considered 
by the Agency.
    This proposed rule is not subject to E.O. 13045 because it is not 
economically significant and does not concern a risk that EPA has 
reason to believe may have a disproportionate effect on children. 
Further, EPA interprets E.O. 13045 as applying only to those regulatory 
actions that are based on health or safety risks, such that the 
analysis required under section 5-501 of the Order has the potential to 
influence the regulation. This proposed rule is not subject to E.O. 
13045 because it does not establish an environmental standard intended 
to mitigate health or safety risks.

H. Executive Order 12875--Enhancing the Intergovernment Partnership

    Under Executive Order 12875, EPA may not issue a regulation that is 
not required by statute and that creates a mandate upon a State, local 
or tribal government, unless the Federal government provides the funds 
necessary to pay the direct compliance costs incurred by those 
governments, or EPA consults with those governments. If EPA complies by 
consulting, Executive Order 12875 requires EPA to provide to the Office 
of Management and Budget a description of the extent of EPA's prior 
consultation with representatives of affected State, local and tribal 
governments, the nature of their concerns, copies of any written 
communications from the governments, and a statement supporting the 
need to issue the regulations. In addition, Executive Order 12875 
requires EPA to develop an effective process permitting elected 
officials and other representatives of State, local and tribal 
governments ``to provide meaningful and timely input in the development 
of regulatory proposals containing significant unfunded mandates.''
    This rule would not create a mandate, or impose any enforceable 
duties, on State, local or tribal governments. It would merely provide 
additional options for analyzing water samples or, for the case of 
magnesium methods, allow certain systems under the D/DBP Rule to 
monitor for magnesium. Accordingly, the requirements of section 1(a) of 
Executive Order 12875 do not apply to this rule.

I. Executive Order 13084--Consultation and Coordination With Indian 
Tribal Governments

    Under Executive Order 13084, EPA may not issue a regulation that is 
not required by statute, that significantly or uniquely affects the 
communities of Indian tribal governments, and that imposes substantial 
direct compliance costs on those communities, unless the Federal 
government provides the funds necessary to pay the direct compliance 
costs incurred by the tribal governments, or EPA consults with those 
governments. If EPA complies by consulting, Executive Order 13084 
requires the Agency to provide to the Office of Management and Budget, 
in a separately identified section of the preamble to the rule, a 
description of the extent of EPA's prior consultation with 
representatives of affected tribal governments, a summary of the nature 
of their concerns, and a statement supporting the need to issue the 
regulation. In addition, Executive Order 13084 requires EPA to develop 
an effective process permitting elected officials and other 
representatives of Indian tribal governments ``to provide meaningful 
and timely input in the development of regulatory policies on matters 
that significantly or uniquely affect their communities.''
    This rule would not significantly or uniquely affect the 
communities of Indian tribal governments. It would

[[Page 2543]]

impose no additional costs on such communities. It would merely provide 
additional options for analyzing water samples or, for the case of 
magnesium methods, allow certain systems under the D/DBP Rule to 
monitor for magnesium. Accordingly, the requirements of section 3(b) of 
Executive Order 13084 do not apply to this rule.

III. References

APHA. American Public Health Association. 1995. Standard Methods for 
the Examination of Water and Wastewater (19th ed.), 1015 Fifteenth 
Street NW, Washington, DC 20005.
ASTM. American Society for Testing and Materials. 1998. Annual Book 
of ASTM Methods, 1998, Vol. 11.01. 101 Barr Harbor Drive, West 
Conshohocken, PA 19428.
EPA. U.S. Environmental Protection Agency. 1994. Methods for the 
determination of metals in environmental samples--Supplement I. EPA-
600/R-94-111.

List of Subjects in 40 CFR Part 141

    Environmental protection, Analytical methods, Chemicals, 
Intergovernmental relations, Reporting and recordkeeping requirements, 
Water supply.

    Dated: January 7, 1999.
Carol M. Browner,
Administrator.

    For the reasons set out in the preamble, part 141 of chapter I 
title 40, Code of Federal Regulations, are proposed to be amended as 
follows:

PART 141--NATIONAL PRIMARY DRINKING WATER REGULATIONS

    1. The authority citation for part 141 continues to read as 
follows:

    Authority: 42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-
5, 300g-6, 300j-4, 300j-9, and 300j-11.

    2. In Sec. 141.21, the Table in paragraph (f)(3) is revised to read 
as follows:


Sec. 141.21  Coliform sampling.

* * * * *
    (f) * * *
    (3) * * *

----------------------------------------------------------------------------------------------------------------
              Organism                                 Methodology                           Citation \1\
----------------------------------------------------------------------------------------------------------------
Total Coliforms \2\................  Total Coliform Fermentation Technique 3, 4, 5..  9221A, B.
                                     Total Coliform Membrane Filter Technique \6\...  9222A, B, C.
                                     Presence-Absence (P-A) Coliform Test 5, 7......  9221D.
                                     ONPG-MUG Test \8\..............................  9223.
                                     Colisure Test \9\
                                     E*Colite Test \10\
                                     ColiBlue24 Test\11\
----------------------------------------------------------------------------------------------------------------
The procedures shall be done in accordance with the documents listed below. The incorporation by reference of
  the following documents was approved by the Director of the Federal Register in accordance with 5 U.S.C.
  552(a) and 1 CFR part 51. Copies of the documents may be obtained from the sources listed below. Information
  regarding obtaining these documents can be obtained from the Safe Drinking Water Hotline at 800-426-4791.
  Documents may be inspected at EPA's Drinking Water Docket, 401 M Street, SW, Washington, D.C. 20460
  (Telephone: 202-260-3027); or at the Office of Federal Register, 800 North Capitol Street, NW, Suite 700,
  Washington, D.C. 20408.
\1\ Methods 9221A,B, 9222A,B,C, 9221D and 9223 are contained in Standard Methods for the Examination of Water
  and Wastewater, 18th edition, 1992 and 19th edition, 1995, American Public Health Association, 1015 Fifteenth
  Street NW, Washington, D.C. 20005; either edition may be used.
\2\ The time from sample collection to initiation of analysis may not exceed 30 hours. Systems are encouraged
  but not required to hold samples below 10  deg.C during transit.
\3\ Lactose broth, as commercially available, may be used in lieu of lauryl tryptose broth, if the system
  conducts at least 25 parallel tests between this medium and lauryl tryptose broth using the water normally
  tested, and this comparison demonstrates that the false-positive rate and false-negative rate for total
  coliform, using lactose broth, is less than 10 percent.
\4\ If inverted tubes are used to detect gas production, the media should cover these tubes at least one-half to
  two-thirds after the sample is added.
\5\ No requirement exists to run the completed phase on 10 percent of all total coliform-positive confirmed
  tubes.
\6\ MI agar also may be used. Preparation and use of MI agar is set forth in the article, ``New medium for the
  simultaneous detection of total coliform and Escherichia coli in water'' by Brenner, K.P., et al., 1993, Appl.
  Environ. Microbiol. 59:3534-3544.
\7\ Six-times formulation strength may be used if the medium is filter-sterilized rather than autoclaved.
\8\ The ONPG-MUG Test is also known as the Autoanalysis Colilert System. A source for this test is referenced at
  Sec.  141.21(f)(5)(iii).
\9\ The Colisure Test must be incubated for 28 hours before examining the results. If an examination of the
  results at 28 hours is not convenient, then results may be examined at any time between 28 hours and 48 hours.
  A description of the Colisure Test may be obtained from the Millipore Corporation, Technical Services
  Department, 80 Ashby Road, Bedford, MA 01730.
\10\ The method description for E*Colite Test is available from Charm Sciences, Inc., 36 Franklin Street,
  Malden, MA 02148-4120.
\11\ The method description for ColiBlue24 Test is available from the Hach Company, 100 Dayton Avenue, Ames, IA
  50010.

* * * * *
    3. In Sec. 141.23, in paragraph (k)(1), the Table is amended by 
adding a new entry for ``magnesium'' and by adding a new methodology to 
the end of the entry for ``lead'' to read as follows:


Sec. 141.23  Inorganic chemical sampling and analytical requirements.

* * * * *
    (k) * * *
    (1) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
           Contaminant                   Methodology            EPA                   ASTM                         SM                     Other
--------------------------------------------------------------------------------------------------------------------------------------------------------
*    *    *    *    *             ........................  ...........  .............................  .......................  Method
Lead ...........................  *    *    *    *    *
                                  Differential Pulse        ...........  .............................  .......................  1001.\13\
                                   Aniodic Stripping
                                   Voltammetry
*    *    *    *    *             *    *    *    *    *     ...........  D 511-93 B...................  3500-Mg B
Magnesium.......................  Atomic Absorption.......   200.7 \14\  .............................  3500-Mg C
                                  ICP.....................  ...........  D 511-93 A...................  3500-Mg E

[[Page 2544]]

 
                                  Complexation Titrametric
                                   Methods
--------------------------------------------------------------------------------------------------------------------------------------------------------
            *                *                *                *                *                *                *
\13\ The description for Method 1001 for lead is available from Palintest LTD, 21 Kenton Lands Road, PO Box 18395, Erlanger, KY 41018.
\14\ The description for EPA Method 200.7 is found in Methods for the Determination of Metals in Environmental Samples--Supplement I (1994). EPA-600/R-
  94-111.
            *                *                *                *                *                *                *

[FR Doc. 99-893 Filed 1-13-99; 8:45 am]
BILLING CODE 6560-50-P