[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: docket@epamail.epa.gov. 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
[[Page 2540]]
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=""><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.="" [[page="" 2541]]="" 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
