[Federal Register Volume 59, Number 100 (Wednesday, May 25, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-12666]


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[Federal Register: May 25, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 103

[Docket No. 92N-0059]

 

Quality Standards for Foods With No Identity Standards; Bottled 
Water

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
standard of quality regulation for bottled water to establish an 
allowable level of 0.005 milligrams per liter (mg/L) for lead in 
bottled water. FDA also is retaining the existing allowable level of 
1.0 mg/L for copper in bottled water. This final rule will ensure both 
that the minimum quality of bottled water with respect to copper and 
lead remains comparable to the quality of public drinking water, and 
that bottled water will be free of any significant lead contamination. 
This final rule is consistent with FDA's goal of reducing consumers' 
exposure to lead in drinking water to the extent practicable.

DATES: Effective November 21, 1994. The Director of the Office of the 
Federal Register approves the incorporation by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51 of certain publications in 21 
CFR 103.35(d)(3)(v), effective November 21, 1994.

FOR FURTHER INFORMATION CONTACT:  Henry S. Kim, Center for Food Safety 
and Applied Nutrition (HFS-306), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-205-4681.

SUPPLEMENTARY INFORMATION:

I. Background

    Under section 410 of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 349), whenever the Environmental Protection Agency 
(EPA) prescribes interim or revised National Primary Drinking Water 
Regulations (NPDWR's) under section 1412 of the Public Health Service 
Act (The Safe Drinking Water Act (SDWA) (42 U.S.C. 300f through 300j-
9)), FDA is required to consult with EPA and either amend its 
regulations for bottled drinking water (Sec. 103.35(21 CFR 103.35)) or 
publish in the Federal Register its reasons for not making such 
amendments.
    In the Federal Register of June 7, 1991 (56 FR 26460), EPA 
published a final rule promulgating NPDWR's that established corrosion 
control treatment technique requirements for controlling lead and 
copper levels in public water systems when these contaminants exceed 
levels of 0.015 mg/L for lead and 1.3 mg/L for copper in more than 10 
percent of targeted tap samples. Targeted tap water samples represent 
samples collected from residences most likely to have lead problems as 
a result of corrosion in the distribution systems. EPA established 
treatment technique requirements rather than maximum contaminant levels 
(MCL's) for lead and copper in drinking water because it believed that 
treatment technique requirements are more appropriate to control 
contamination of lead and copper that is largely the result of 
circumstances beyond the direct control of public water systems (i.e., 
corrosion in service lines not owned by the systems and in the plumbing 
of residences and buildings). In addition, EPA established maximum 
contaminant level goals (MCLG's) of zero for lead and 1.3 mg/L for 
copper which are based solely on considerations of protecting the 
public from the adverse health effects of these contaminants in 
drinking water.
    In accordance with section 410 of the act, FDA published in the 
Federal Register of January 5, 1993 (58 FR 389), a proposal to amend 
the quality standard for bottled water to establish an allowable level 
of 0.005 mg/L for lead and to retain the existing allowable level of 
1.0 mg/L for copper. FDA proposed a lower level of 0.005 mg/L for lead 
in bottled water than EPA's level of 0.015 mg/L for lead in drinking 
water that triggers treatment technique requirements. FDA's data showed 
that most bottlers do not normally experience the significant lead 
contamination problems from corrosion of materials that are presented 
by public water distribution systems and residential plumbing (e.g., 
pipes, faucets, and solder), and that bottlers can produce bottled 
water products with lead levels below 0.005 mg/L. Furthermore, this 
level represents the lowest level at which FDA can take enforcement 
action because it corresponds to the practical quantitation limit (PQL) 
of the best available analytical methods for determining lead levels in 
water. Finally, FDA noted that establishing the allowable level for 
lead at 0.005 mg/L would provide public health protection at least 
equivalent to that provided by EPA's NPDWR and would ensure that 
bottled water products are free of significant lead contamination.
    With respect to the allowable level for copper, the existing 
allowable level of 1.0 mg/L in bottled water is below EPA's MCLG of 1.3 
mg/L and is equivalent to EPA's secondary maximum contaminant level 
(SMCL), which is based on the aesthetic effects of copper in drinking 
water. Thus, FDA proposed to retain the existing allowable level to 
ensure that levels of copper in bottled water meet the safety and 
aesthetic criteria that EPA has established for copper in drinking 
water.
    On November 8, 1990, the enactment of the Nutrition Labeling and 
Education Act of 1990 (Pub. L. 101-535) removed standard of quality 
rulemakings from the coverage of the formal rulemaking procedures in 
section 701(e) of the act (21 U.S.C. 371(e)). FDA, therefore, proposed 
the amendments to the bottled water quality standard regulations for 
lead and copper using notice and comment rulemaking under section 
701(a) of the act. Interested persons were given until March 8, 1993, 
to comment on the proposed regulation.

II. Summary of and Response to Comments

A. Summary of Comments

    FDA received approximately 130 responses to the January 5, 1993, 
proposal. Each of these responses contained one or more comments from 
industry, consumers, trade associations, Federal government officials, 
State government agencies, consumer advocacy organizations, and a 
private research foundation. The comments generally supported the 
proposal. Many comments addressed issues that are outside the scope of 
the proposal (e.g., allowable levels for total trihalomethanes, 
chlorine, and fluoride in the quality standard for bottled water). 
These comments will not be discussed here. A number of comments 
suggested modifications to, or were opposed to, various provisions of 
the proposal. A summary of the suggested changes, the opposing 
comments, and the agency's responses follows.

B. Response to Comments

    1. Most comments supported the proposed allowable levels of 0.005 
mg/L for lead and 1.0 mg/L for copper in the quality standard for 
bottled water. One comment, however, stated that the allowable level 
for lead in bottled water should not be any lower than EPA's corrosion 
treatment trigger level of 0.015 mg/L for lead in drinking water 
because this level corresponds to an average lead level of 0.005 mg/L, 
the level which most bottled waters do not exceed. The comment argued 
that the fact that 0.005 mg/L is at the lower limit of reliable 
measurement for lead does not justify setting a standard at that level. 
The comment further argued that setting a standard for lead in bottled 
water is not necessary because lead content is not a problem in bottled 
water. The comment maintained that imposing regulations for the sake of 
regulation is a problem because of the high costs incurred by diverting 
FDA resources from significant regulatory concerns.
    FDA disagrees with this comment. Under section 410 of the act, 
FDA's approach has been to respond to EPA's promulgation of drinking 
water regulations under the SDWA by amending the quality standard for 
bottled water to maintain compatibility with EPA's regulations. FDA 
concludes that amending the standard for lead in bottled water to 0.005 
mg/L is fully compatible and consistent with the EPA standard.
    Based on the available health effects information, EPA established 
an MCLG of zero for lead in drinking water. By adopting this MCLG, EPA 
was in effect saying that if zero lead in drinking water can be 
achieved, it should be achieved. However, EPA concluded that zero lead 
in public drinking water could not be achieved because of contamination 
of the water with lead from corrosion of lead-containing materials in 
public water distribution systems and in residential plumbing. To 
control this contamination, EPA established treatment technique 
requirements which are triggered when more than 10 percent of the 
targeted tap water samples exceeds 0.015 mg/L for lead.
    Bottled water, however, generally does not have significant lead 
contamination problems. FDA conducted a survey of bottled water in 1990 
(Ref. 1), and the findings of that survey show that most bottlers are 
using source waters that are free of significant lead contamination and 
can readily produce bottled water products with lead levels below 0.005 
mg/L, the PQL for lead in water. Consequently, because this level, 
which is as close to EPA's MCLG of zero as possible, is achievable in 
bottled water, there is no reason for FDA to rely on EPA's 0.015 mg/L 
trigger level in establishing an allowable level for lead in bottled 
water. In fact, in its review and comment on FDA's proposal (before it 
published in the Federal Register), EPA stated that the regulatory 
approach taken by FDA to establish an allowable level of 0.005 mg/L for 
lead in bottled water is consistent with the intent of the NPDWR for 
lead in public drinking water (Ref. 4).
    2. One comment asserted that there is no safe threshold for lead in 
drinking water and, because technological resources and knowledge make 
it feasible to measure lead in water at the 0.002 mg/L level, FDA 
should establish the allowable level for lead in bottled water at that 
level. The comment contended that, because large water companies have 
been testing for lead and reporting lead levels of 0, 0.001, 0.002, 
0.003, and 0.004 mg/L to EPA, the PQL is substantially lower than 0.005 
mg/L. The comment stated that another organization, which has limited 
resources and is not in the business of supplying water commercially, 
uses a laboratory that has found the PQL to be 0.002 mg/L when testing 
for lead in bottled water. The comment further argued that EPA's PQL 
concept is theoretically inappropriate for safety determinations 
because the error theory of laboratory measurements (i.e., the 
distinction between the standard error of a single measurement and the 
standard error among a group of measurements) upon which EPA bases its 
determination of the PQL is misleading.
    FDA disagrees that EPA's PQL concept is inappropriate. EPA's PQL is 
set at the lowest concentration for a contaminant that laboratories 
certified by the States or by EPA for water analyses can reliably 
measure within specified limits of precision and accuracy under routine 
laboratory operating conditions. EPA also determines the PQL based on 
the method detection limit (MDL), which is defined as the lowest 
concentration of a substance that can be measured with 99 percent 
confidence that the true value is greater than zero. EPA generally sets 
the PQL at 5 to 10 times the MDL, depending on the degree of health 
risk posed by a contaminant (for contaminants like lead that pose a 
high degree of health risk, EPA sets the PQL at 5 times the MDL), and, 
if possible, confirms the PQL by interlaboratory performance evaluation 
studies.
    Based on EPA's calculation of a 0.001 mg/L MDL for lead by the most 
sensitive analytical methods available, EPA set the PQL for lead at 
0.005 mg/L. EPA confirmed this level by performance evaluation studies 
that evaluated the ability of EPA, State, and non-EPA and State 
laboratories to analyze water samples with low lead levels (56 FR 26460 
at 26511, June 7, 1991).
    Although the comment stated that a laboratory used by another 
organization found the PQL to be 0.002 mg/L for lead in bottled water, 
it did not provide any data to support that laboratory's determination. 
Therefore, this comment has not provided an adequate basis upon which 
to call into question EPA's PQL.
    In summary, based on the studies conducted by EPA establishing a 
PQL of 0.005 mg/L for lead in drinking water, FDA finds that an 
allowable level of 0.005 mg/L for lead in the quality standard for 
bottled water is appropriate.
    3. Another comment stated that, although it strongly endorsed the 
proposed allowable level for lead in bottled water, FDA should review 
this standard in a few years because EPA's 1991 rule for lead in 
drinking water has led to increased analysis for lead in water, and, 
using the best available methodology, many laboratories can now 
routinely measure lead levels at 0.001 or 0.002 mg/L in water samples. 
The comment maintained that measurement of lead in water at these 
levels may soon be the standard, ``state of the art'' technology, and 
that it would be appropriate to set the allowable level in bottled 
water at the limit of detection, i.e., 0.005 mg/L, or no detectable 
lead, whichever is less.
    FDA disagrees that establishing the allowable level for lead in 
bottled water at the limit of detection, i.e., 0.005 mg/L, or no 
detectable lead, whichever is less, is appropriate. As discussed above, 
0.005 mg/L, the PQL for lead in water, represents the lowest 
concentration that State- or EPA-certified laboratories for water 
analyses can reliably measure within specified limits of precision and 
accuracy under routine laboratory operating conditions. FDA recognizes 
that lead levels in water can be measured below 0.005 mg/L. However, to 
take an enforcement action based on level of a contaminant in a food, 
FDA must be able to reliably establish the level of the contaminant in 
the food. EPA's PQL of 0.005 mg/L has been confirmed by performance 
evaluation studies as the lowest level of lead in water samples that 
can be reliably and consistently measured (56 FR 26460 at 26511). Thus, 
FDA has concluded that reliance on the PQL as the allowable level for 
lead in bottled water is appropriate.
    Nevertheless, FDA agrees that technology for analytical methodology 
is constantly advancing. Reliable measurement of lead levels below 
0.005 mg/L in water samples, within specified limits of precision and 
accuracy under routine laboratory operating conditions, may soon become 
the general norm. Therefore, FDA agrees with the comment that within 
the next few years, it should consult with EPA about reevaluating the 
PQL for lead in water. Moreover, FDA recognizes that, should EPA revise 
the PQL, FDA will need to consider whether an allowable level for lead 
in bottled water below 0.005 mg/L is appropriate.
    4. A State government agency and a majority of the comments from 
industry and trade associations opposed the statement in the proposal 
that if the proposal becomes a final rule, bottlers will be required to 
test each lot of bottled water to ensure that it contains less than 
0.005 mg/L of lead. The comments argued that, because most bottlers are 
routinely meeting the 0.005 mg/L standard for lead, a requirement for 
testing each lot of bottled water for lead is not necessary. 
Furthermore, the majority of the comments argued that testing each lot 
of bottled water for lead would impose a significant financial burden 
on the bottled water industry. For example, comments from two trade 
associations representing bottled water manufacturers maintained that a 
requirement for testing each lot of bottled water for lead would impose 
additional annual costs that they estimated at $15,000 for a small 
bottler and $300,000 for a large bottler.
    Under the current good manufacturing practice (CGMP) regulations 
for the processing and bottling of bottled drinking water (part 129 (21 
CFR part 129)), bottlers are required to analyze, at least annually, 
for chemical contaminants, including lead, in a representative sample 
from a batch or a segment of a continuous production run for each type 
of bottled drinking water produced during a day's production 
(Sec. 129.80(g)(2)). Therefore, bottlers will not be required to test 
each lot of bottled water for the presence of lead. The statement that 
they would, which was inadvertently included in the economic impact 
analysis, was in error.
    However, FDA reminds water bottlers that each lot of bottled water 
must comply with the quality standard for chemical contaminants, and 
compliance with the minimum annual testing requirements of the CGMP 
does not exempt a firm from regulatory action if any lot of bottled 
water does not meet any provision of the chemical quality standard.
    5. Several comments recommended that testing for chemical 
contaminants (e.g., lead and copper) should be more frequent than the 
required minimum of annual testing. One comment noted that, although 
FDA has established quality standards for bottled water, it did not set 
any requirements for monitoring timeframes or submission of results to 
ensure that bottlers meet the quality standards. Moreover, the comment 
objected to allowing distribution of a bottled water product that is 
below the water quality standard, arguing that, given the emphasis on 
the quality of bottled water verses tap water by the bottled water 
industry, bottlers are not likely to print a ``substandard'' statement 
on the label.
    FDA agrees that bottlers are not likely to market bottled water 
that would be required to bear a statement of substandard quality with 
respect to lead. However, FDA notes that the use of such a statement on 
the label of a food covered by a standard of quality is specifically 
provided for by section 403(h)(1) of the act (21 U.S.C. 343(h)(1)), if 
that food falls below the prescribed quality standard. Therefore, FDA 
cannot preclude the use of the statement of substandard quality. 
Nonetheless, Sec. 103.35(g) provides that any bottled water containing 
a substance at a level considered injurious to health under section 402 
of the act (21 U.S.C. 342) is deemed to be adulterated and may be 
subject to regulatory action, even if the bottled water bears a label 
statement of substandard quality.
    FDA notes that the CGMP regulations for processing and bottling of 
bottled drinking water (part 129) require that the water to be bottled 
be obtained from an approved source properly located, protected, and 
operated; be of a safe, sanitary quality; and be in compliance at all 
times with the applicable laws and regulations of the government agency 
or agencies having jurisdiction (Sec. 129.35). In addition, 
Sec. 129.35(a) requires that samples of source water be analyzed as 
often as necessary, but at least once each year, for chemical 
contaminants, and Sec. 129.80(g) requires that each type of bottled 
water product be analyzed at least annually for chemical contaminants. 
Moreover, Sec. 129.80(h) requires that records of the results for these 
tests be maintained at the plant for at least 2 years and be available 
for official review at reasonable times. FDA is not aware of any data 
or other information that suggests that requiring all bottlers to test 
for lead more frequently is necessary to ensure that bottled water is 
safe and of acceptable quality.
    FDA emphasizes that water bottlers are responsible for ensuring, 
through appropriate manufacturing techniques and sufficient quality 
control procedures, that all bottled water products introduced or 
delivered for introduction into interstate commerce are safe, 
wholesome, and truthfully labeled, and that they comply with the 
provisions of the quality standard. Therefore, should any bottler 
encounter circumstances that would warrant testing for lead more 
frequently than once per year, the bottler is required to do such 
testing to ensure the safety and quality of the bottled water.
    For the reasons stated above, FDA concludes that the testing 
requirements for contaminants in bottled water contained in the CGMP 
regulations (part 129) are appropriate and sufficient to ensure the 
quality and safety of bottled water products. Thus, the agency finds 
that revision of the CGMP regulations to require more frequent testing 
for chemical contaminants in bottled water is not necessary at this 
time.
    6. A majority of responses from industry opposed the exemption of 
mineral water from the lead standard for bottled water. Another comment 
stated that the lead standard should apply to other types of bottled 
beverages, including mineral water, soda water, and seltzer.
    Under the provisions of Sec. 103.35, the definition of ``bottled 
water'' excludes mineral water or any type of soft drink commonly known 
as soda water. Consequently, these types of products are exempt from 
the provisions of the quality standard for bottled water, including the 
allowable level for lead. However, in a proposal to establish a 
standard of identity for bottled water (57 FR 393, January 5, 1993), 
FDA proposed to revise the definition for ``bottled water'' in the 
quality standard to include mineral water. Should FDA adopt that 
proposal, the allowable level of 0.005 mg/L for lead will apply to 
mineral water. Even if the agency does not adopt this change, because 
of the health concerns raised by lead, the agency is likely to take 
some action to regulate the level of lead in mineral water.
    In regard to soda water and seltzer, FDA considers these types of 
products to be soft drinks and not bottled water. Consequently, they 
are not covered by regulations that address bottled water. The agency's 
reasons for considering these types of products as soft drinks are 
fully discussed in its proposal to establish an identity standard for 
bottled water (57 FR 393 at 395). Soft drinks are subject to regulatory 
action, however, if they contain a level of lead that may render the 
food injurious to health.
    7. One comment from a trade association representing public water 
supply agencies recommended that FDA review the latest EPA analytical 
techniques for determining lead and copper with respect to the use of 
nitric acid digestion and incorporate this procedure as applicable.
    In accordance with FDA's responsibilities pursuant to section 410 
of the act, FDA consulted with EPA by requesting EPA's review and 
comment on the proposal to amend the quality standard for lead and 
copper in bottled water. In response, EPA stated that FDA's regulatory 
approach for lead and copper in bottled water is consistent with the 
intent of EPA's NPDWR's for lead and copper and concurred with the 
analytical methods that FDA cited for determining lead and copper in 
bottled water (Ref. 4). Furthermore, in EPA Methods 200.7, 200.8, and 
200.9, which FDA proposed to incorporate by reference, the sample 
preparation procedures for measuring lead and copper as total 
recoverable metals call for a nitric acid or nitric acid-hydrochloric 
acid digestion.

III. Conclusions

    The agency is adopting the provisions concerning lead and copper in 
the quality standard for bottled water as proposed (58 FR 389, January 
5, 1993). The majority of the comments that the agency received 
supported the proposal. Furthermore, after carefully considering the 
comments that the agency received that suggested modifications to, or 
were opposed to, aspects of the proposal, the agency has determined 
that no changes are warranted. Therefore, upon the effective date of 
this rule, November 21, 1994, any bottled water that contains an amount 
of lead or copper that exceeds the allowable levels will be misbranded 
under section 403(h)(1) of the act unless the bottled water bears a 
statement of substandard quality as provided by Sec. 103.35(f)(2)(ii).
    FDA has made one minor change concerning the analytical methods for 
the determination of lead and copper cited in new Sec. 103.35(d)(3)(v). 
The sources for these methods will be the National Technical 
Information Services rather than EPA. This change is consistent with 
the agency's practice of relying on readily available commercial 
sources for incorporated materials when possible.

IV. Environmental Impact

    The agency previously considered the environmental effects of this 
rule, as announced in the proposed rule (58 FR 389, January 5, 1993). 
At that time, the agency concluded that the action would not have a 
significant impact on the human environment, and that an environmental 
impact statement is not required. The agency's environmental assessment 
and finding of no significant impact for the proposal were displayed at 
the Dockets Management Branch at the time of the proposal. FDA has 
received no new information or comments that would affect the agency's 
previous determination that there is no significant impact on the human 
environment, and that an environmental impact statement is not 
required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because FDA has received no new information or 
comments that would alter its tentative finding in the proposal that 
there is no substantive economic issue, the agency certifies that the 
final rule will not have a significant economic impact on a substantial 
number of small entities. Therefore, under the Regulatory Flexibility 
Act, no further analysis is required.

VI. References

    The following references have been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, rm. 1-23, 
12420 Parklawn Dr., Rockville, MD 20857, and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. FDA FY 90 Bottle Water Survey, 1990.
    2. FDA internal memorandum of meeting, Discussions on the 
Analytical Methods for Determination of Lead in Bottled Water, 
December 20, 1991.
    3. ``Twenty Questions Concerning Bottled Water,'' International 
Bottled Water Association, 1990.
    4. James M. Conlon, Drinking Water Standards Division, EPA, 
letter to Henry S. Kim, February 14, 1992.

List of Subjects in 21 CFR Part 103

    Beverages, Bottled water, Food grades and standards, Incorporation 
by reference.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
103 is amended as follows:

PART 103--QUALITY STANDARDS FOR FOODS WITH NO IDENTITY STANDARDS

    1. The authority citation for 21 CFR part 103 continues to read as 
follows:

    Authority: Secs. 201, 401, 403, 409, 410, 701, 721 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 341, 343, 348, 
349, 371, 379e).

    2. Section 103.35 is amended in the table in paragraph (d)(1)(i) by 
removing the entries for ``Copper'' and ``Lead,'' by revising the 
introductory text of paragraph (d)(3), and by adding new paragraphs 
(d)(3)(i) and (d)(3)(v) to read as follows:


Sec. 103.35  Bottled water.

* * * * *
    (d) * * *
    (3) Having consulted with the U.S. Environmental Protection Agency 
(EPA) as required by section 410 of the Federal Food, Drug, and 
Cosmetic Act, the Food and Drug Administration has determined that 
bottled water, when a composite of analytical units of equal volume 
from a sample is examined by the methods listed in paragraphs (d)(3)(v) 
and (d)(3)(vi) of this section, shall not contain the following 
chemical contaminants in excess of the concentrations specified in 
paragraphs (d)(3)(i) and (d)(3)(ii) of this section.
    (i) The allowable levels for inorganic substances are as follows:


------------------------------------------------------------------------
                                      Concentration milligrams per liter
            Contaminant                       (or as specified)         
------------------------------------------------------------------------
Copper.............................  1.0                                
Lead...............................  0.005                              
------------------------------------------------------------------------

* * * * *
    (iii) and (iv) [Reserved]
     (v) Analyses to determine compliance with the requirements of 
paragraph (d)(3)(i) of this section shall be conducted in accordance 
with an applicable method and applicable revisions to the methods 
listed in paragraphs (d)(3)(v)(G) and (d)(3)(v)(H) of this section and 
described, unless otherwise noted, in ``Methods for Chemical Analysis 
of Water and Wastes,'' U.S. EPA Environmental Monitoring and Support 
Laboratory, EPA-600/4-79-020, March 1983, which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies 
of this publication are available from the National Technical 
Information Service, U.S. Department of Commerce, 5825 Port Royal Rd., 
Springfield, VA 22161, or may be examined at the Office of Plant and 
Dairy Foods and Beverages (HFS-305), Center for Food Safety and Applied 
Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC 
20204, or at the Office of the Federal Register, 800 North Capitol St., 
NW., suite 700, Washington, DC.
    (A)-(F) [Reserved]
     (G) Copper shall be measured as total recoverable metal without 
filtration using the following methods:
    (1) Method 220.2--Atomic absorption; furnace technique, in 
``Methods for Chemical Analysis of Water and Wastes,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51 or
    (2) Method 220.1--Atomic absorption; direct aspiration, in 
``Methods for Chemical Analysis of Water and Wastes,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given 
in paragraph (d)(3)(v) of this section.
    (3) Method 200.7--entitled ``Determination of Metals and Trace 
Elements in Water and Wastes by Inductively Coupled Plasma-Atomic 
Emission Spectrometry,'' Revision 3.3, April 1991, U.S. EPA, 
Environmental Monitoring and Support Laboratory (EMSL). The revision is 
contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' Office of Research and Development, 
Washington, DC 20460, (EPA/600/4-91/010), June 1991, which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of this publication are available from the National 
Technical Information Service, U.S. Department of Commerce, 5825 Port 
Royal Rd., Springfield, VA 22161, or may be examined at the Office of 
Plant and Dairy Foods and Beverages (HFS-305), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, or at the Office of the Federal Register, 800 
North Capitol St. NW., suite 700, Washington, DC.
    (4) Method 200.8--entitled, ``Determination of Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' 
Revision 4.4, April 1991, U.S. EPA, EMSL. The revision is contained in 
the manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of 
this incorporation by reference is given in paragraph (d)(3)(v)(G)(3) 
of this section.
    (5) Method 200.9--entitled, ``Determination of Trace Elements by 
Stabilized Temperature Graphite Furnace Atomic Absorption 
Spectrometry,'' Revision 1.2, April 1991, U.S. EPA, EMSL. The revision 
is contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,'' which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability 
of this incorporation by reference is given in paragraph 
(d)(3)(v)(G)(3) of this section.
    (H) Lead shall be measured as total recoverable metal without 
filtration using the following methods:
    (1) Method 239.2--Atomic absorption; furnace technique, from 
``Methods for Chemical Analysis of Water and Wastes,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of this incorporation by reference is given 
in paragraph (d)(3)(v) of this section.
    (2) Method 200.8--entitled, ``Determination of Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' 
Revision 4.4, April 1991. The revision is contained in the manual 
entitled ``Methods for the Determination of Metals in Environmental 
Samples,'' June 1991, which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this 
incorporation by reference is given in paragraph (d)(3)(v)(G)(3) of 
this section.
    (3) Method 200.9--from ``Determination of Trace Elements by 
Stabilized Temperature Graphite Furnace Atomic Absorption 
Spectrometry,'' Revision 1.2, April 1991. The revision is contained in 
the manual entitled ``Methods for the Determination of Metals in 
Environmental Samples,'' June 1991, which is incorporated by reference 
in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability 
of this incorporation by reference is given in paragraph 
(d)(3)(v)(G)(3) of this section.
* * * * *

    Dated: May 17, 1994.
 Michael R. Taylor,
 Deputy Commissioner for Policy.
[FR Doc. 94-12666 Filed 5-24-94; 8:45 am]
BILLING CODE 4160-01-F