[Federal Register Volume 61, Number 59 (Tuesday, March 26, 1996)]
[Rules and Regulations]
[Pages 13258-13270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6940]




[[Page 13257]]

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Part III





Department of Health and Human Services





_______________________________________________________________________



Food and Drug Administration



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21 CFR Part 165



Beverages: Bottled Water; Final Rule

  Federal Register / Vol. 61, No. 59 / Tuesday, March 26, 1996 / Rules 
and Regulations  

[[Page 13258]]


DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. 93N-0085]


Beverages: 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 quality 
standard for bottled water by establishing or revising allowable levels 
for 5 inorganic chemicals (IOC's) and 17 synthetic organic chemicals 
(SOC's), including 3 synthetic volatile organic chemicals (VOC's), 9 
pesticide chemicals, and 5 nonpesticide chemicals. However, FDA is 
staying the effective date for the allowable levels for the 5 IOC's and 
4 of the SOC's. FDA also is not changing the existing allowable level 
for sulfate in the bottled water quality standard. In addition, FDA is 
deferring final action on the proposed allowable level for the 
nonpesticide chemical di(2-ethylhexyl)phthalate (DEHP). This final rule 
will ensure that the minimum quality of bottled water, as affected by 
at least the 13 chemicals for which allowable levels are adopted and 
effective, remains comparable with the quality of public drinking water 
that meets the Environmental Protection Agency (EPA) standards.

DATES: The regulation is effective September 23, 1996. 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 165.110(b)(4)(iii), effective September 
23, 1996.

FOR FURTHER INFORMATION CONTACT: Henry S. Kim, Center For Food Safety 
and Applied Nutrition (HFS-306), Food and Drug Administration, 200 C 
Street 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 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 in 
Sec. 165.110 (21 CFR 165.110) or publish in the Federal Register its 
reasons for not making such amendments.
    In the Federal Register of July 17, 1992 (57 FR 31776) (hereinafter 
referred to as the July 1992 final rule), EPA published a final rule 
promulgating NPDWR's consisting of maximum contaminant levels (MCL's) 
for 18 SOC's and 5 IOC's. Further, in that final rule, EPA deferred 
establishing an MCL for sulfate in public drinking water.
    In accordance with section 410 of the act, FDA published in the 
Federal Register of August 4, 1993 (58 FR 41612), a proposal to adopt 
EPA's MCL's for the 18 SOC's and 5 IOC's as allowable levels in the 
quality standard for bottled water (hereinafter referred to as the 
August 1993 proposal). In the August 1993 proposal, FDA tentatively 
concluded that the MCL's that EPA had established based on available 
toxicological information for the 18 SOC's and 5 IOC's in public 
drinking water were adequate to protect the public from the adverse 
health effects of these chemical contaminants in drinking water. 
Further, FDA tentatively concluded that adopting EPA's MCL's for the 18 
SOC's and 5 IOC's as allowable levels in the bottled water quality 
standard was appropriate to protect the public from the adverse health 
effects of these chemical contaminants that may be found in bottled 
water.
    FDA did not propose any change in the existing allowable level of 
250 milligrams per liter (mg/L) for sulfate in bottled water. FDA had 
established this level in 1973 (38 FR 32558, November 26, 1973), based 
on the Public Health Service standard for sulfate in drinking water 
established on March 6, 1962 (27 FR 2152). Although EPA proposed to 
establish either 400 or 500 mg/L as the MCL for sulfate in public 
drinking water (55 FR 30370, July 25, 1990), it deferred action on this 
MCL in its July 1992 final rule and did not revise the existing 
secondary maximum contaminant level (SMCL) of 250 mg/L for this 
chemical (40 CFR 143.3) in public drinking water.

II. Summary of and Response to Comments

A. Summary of Comments

    FDA received 11 comments in response to the August 1993 proposal. 
The comments represented the views of three foreign trade associations 
and one domestic trade association that represent bottled water 
manufacturers, two State health departments, a State environmental 
protection department, a European Communities General Agreement for 
Tariffs and Trade (EC GATT) Enquiry Point, a bottled water company, a 
supplier of packaging materials, and a nonprofit private organization. 
The majority of the comments stated that they generally supported the 
proposal. Two comments addressed the issue of Federal preemption of 
State requirements concerning the quality of bottled water and related 
monitoring requirements. The issue of Federal preemption of State 
requirements is outside the scope of the proposal and thus 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. Comments Pertaining to Allowable Levels in the Quality Standard for 
Bottled Water

    1. One of the comments addressed the proposed allowable level of 
0.006 mg/L for the chemical, DEHP. The comment pointed out that this 
chemical is prior sanctioned in Sec. 181.27 (21 CFR 181.27) for use as 
a plasticizer when migrating from food-packaging material into foods 
with high water content and, as such, is approved for use in contact 
with food in Sec. 177.1210 (21 CFR 177.1210) Closures with sealing 
gaskets for food containers. The comment also pointed out that DEHP is 
routinely used as a plasticizer in gaskets used in metal and plastic 
closures for the packaging of bottled water in accord with this 
approval, and that such use may result in levels of this chemical 
migrating into water that exceed the proposed allowable level. Thus, 
the comment maintained that finalizing the proposed allowable level for 
DEHP would result in a limit on the level of this chemical in bottled 
water that conflicts with this chemical's permitted use under the 
existing food additive regulation for closures with sealing gaskets, 
and that taking such action would effectively ban the use of this 
plasticizer. The comment further pointed out that gaskets containing 
DEHP are permitted for use in packaging food and bottled water under 
relevant European national regulations, and that these uses comply with 
the migration limit of 3 mg/kilograms proposed for DEHP established by 
the Scientific Committee for Food in their Synoptic Document 7.
    FDA was not aware of the potential conflict between the proposed 
allowable level for DEHP and the existing prior sanction for this 
substance in Sec. 181.27 at the time it published the proposal. The 
agency needs additional time to evaluate this matter and to determine 
an

[[Page 13259]]
appropriate course of action with respect to the proposed allowable 
level for DEHP. Therefore, FDA is deferring final action on the 
proposed allowable level for DEHP at this time.
    2. Several comments asked FDA to clarify the status of bottled 
water products labeled as mineral water with respect to compliance with 
the existing allowable level of 250 mg/L for sulfate in bottled water. 
The comments stated that, in the Federal Register of January 5, 1993 
(58 FR 393), FDA proposed to exempt bottled mineral water from 
complying with the allowable levels for certain substances, such as 
sulfate, that may be present at high levels in some mineral waters 
because the allowable levels in question have been established for 
aesthetic reasons and not for public health protection.
    FDA did not fully address this issue in the August 1993 proposal. 
These comments are correct in noting that in January of 1993, FDA 
proposed to subject bottled mineral water to the bottled water quality 
standard but to exempt mineral water from complying with certain 
allowable levels, including that for sulfate, that were established for 
aesthetic reasons and not for public health protection. The January 
1993 proposal was still pending when the August 1993 proposal was 
published. Bottled mineral water was not yet subject to the bottled 
water quality standard. Therefore, in addressing the allowable level 
for sulfate in the August 1993 proposal, FDA did not provide in the 
codified material that bottled mineral water would be exempt from the 
quality standard for sulfate.
    In the Federal Register of November 13, 1995 (60 FR 57076) 
(hereinafter referred to as the November 1995 final rule), FDA 
published a final rule based on the January 1993 proposal that, among 
other things, established a standard of identity for bottled water (21 
CFR part 165), which includes a definition for mineral water and which 
subjects mineral water to the quality standard regulations for bottled 
water. Bottled mineral water must also comply with the current good 
manufacturing practice (CGMP) regulations for bottled water in part 129 
(21 CFR part 129). Thus, under the newly established regulations, 
bottled waters that meet the definition for ``mineral water'' in 
Sec. 165.110(a)(2)(iii) must comply with the bottled water quality 
standard (i.e., the allowable levels for physical, chemical, 
microbiological, and radiological contaminants) in Sec. 165.110(b).
    However, FDA recognizes that mineral water with a high mineral 
content may not meet the allowable levels in the quality standard for 
certain physical and chemical attributes (i.e., color, odor, total 
dissolved solids (TDS), chloride, iron, manganese, sulfate, and zinc) 
that are based on EPA's SMCL's and, as such, are intended only to 
ensure the aesthetic quality of the water, i.e., SMCL's are not 
established for public health reasons. Consequently, in the November 
1995 final rule (60 FR 57076 at 57125), FDA included provisions that 
exempt bottled mineral waters that meet the definition for ``mineral 
water'' in Sec. 165.110(a)(2)(iii) from complying with the allowable 
levels for color, odor, TDS, chloride, iron, manganese, sulfate, and 
zinc. Therefore, bottled mineral waters do not have to comply with the 
allowable level of 250 mg/L for sulfate. FDA reflected this fact in the 
November 1995 final rule (60 FR 57076 at 57125) by including a footnote 
to the entry for sulfate in the listing of allowable levels under 
Sec. 165.110(b)(4)(I)(A). Therefore, no action in response to this 
comment is necessary in this final rule.
    3. One comment from an EC GATT Enquiry Point questioned whether 
European mineral waters that meet EC Council Directive 80/777/EEC of 
July 15, 1980, which established standards relating to the exploitation 
and marketing of natural mineral waters for member countries of the EC, 
but that contain levels of chemical contaminants that exceed FDA's 
proposed allowable levels, particularly those allowable levels that are 
based on EPA's SMCL's, can be marketed in the United States. The 
comment stated that European mineral waters should be exempt from 
complying with allowable levels that are based on aesthetic factors to 
prevent any unnecessary trade barriers.
    The same comment also stated that, with regard to drinking waters, 
the proposed standards for barium, chloride, copper, fluoride, nitrate, 
trihalomethanes, TDS, and zinc are stricter than those established in 
EC Council Directive 80/778/EEC of July 15, 1980, relating to the 
quality of water intended for human consumption (other than natural 
mineral waters and medicinal waters). Moreover, the comment stated that 
EC Council Directive 80/778/EEC does not contain any limit for 
beryllium, thallium, dichloromethane, 1,2,4-trichlorobenzene, 1,1,2-
trichloroethane, dioxin, DEHP, di(2-ethylhexyl)adipate (DEHA), and 
hexachlorocyclopentadiene. Consequently, the comment questioned whether 
European bottled waters that comply with EC Council Directive 80/778/
EEC will be accepted on the U.S. market, or whether the allowable 
levels for chemical contaminants addressed in this final rule might 
create technical barriers to trade.
    With regard to the U.S. standards for barium, chloride, copper, 
fluoride, nitrate, trihalomethanes, TDS, and zinc, FDA notes that the 
allowable levels for these chemical contaminants were established in 
previous rulemakings and thus are outside the scope of this rulemaking.
    Further, FDA disagrees with the comment's assertion that trade 
barriers might be created because European bottled water products 
meeting EC Council Directives 80/777/EEC and 80/778/EEC may not meet 
the allowable levels for certain chemical contaminants in the quality 
standard for bottled water for the following two reasons:
    First, as stated above, FDA recognizes that the levels of these 
physical and chemical contaminants in bottled mineral waters with high 
mineral content may exceed the allowable levels.
    Thus, in the November 1995 final rule, FDA has provided that 
bottled mineral waters are exempt from complying with the allowable 
levels for color, odor, TDS, chloride, iron, manganese, sulfate, and 
zinc that are all based upon EPA's SMCL's. Therefore, European bottled 
mineral waters that meet the definition for ``mineral water'' in 
Sec. 165.110(a)(2)(iii) do not have to comply with the allowable levels 
for these contaminants in the quality standard for bottled water. There 
is, consequently, no basis for the concern expressed by the comment.
    Second, with respect to other chemical contaminants (i.e., 
beryllium, thallium, dichloromethane, 1,2,4-trichlorobenzene, 1,1,2-
trichloroethane, hexachlorocyclopentadiene, dioxin, DEHP, and DEHA) 
addressed in this final rule and for which no limits are established in 
the EC Council Directive 80/778/EEC, the comment did not provide any 
evidence of any European bottled waters that would not meet the 
allowable levels for these chemical contaminants. In addition, except 
for the chemical DEHP, FDA is not aware of any evidence that would 
indicate that European bottled waters would not meet the allowable 
levels for the chemical contaminants addressed in this final rule.
    Moreover, if a bottled water product (domestic or imported) exceeds 
an allowable level for a particular contaminant, under the labeling 
provisions of Sec. 165.110(c), the bottler can still market that 
product, provided that the labeling bears a statement of substandard 
quality (e.g., if it exceeds the allowable level for thallium, the

[[Page 13260]]
labeling shall state either ``Contains Excessive Thallium'' or 
``Contains Excessive Chemical Substances'' if the bottled water is not 
mineral water under Sec. 165.110(c)(3)). Therefore, should a European 
or an American bottled water product exceed the allowable levels for 
certain contaminants, it still can be marketed in the United States if 
its labeling bears the prescribed statement for those contaminants.
    Consequently, because FDA does not expect that European bottled 
waters will exceed the allowable levels for the chemical contaminants 
addressed in this final rule, and because bottled water that exceeds 
the allowable level for a contaminant can still be sold in the United 
States if it bears the prescribed label statement, FDA rejects the 
comment's suggestion that this final rule will create technical trade 
barriers.
    However, FDA reminds water bottlers (domestic and foreign) that any 
bottled water containing a substance at a level considered injurious to 
health is adulterated under section 402(a)(1) of the act (21 U.S.C. 
342(a)(1)) and is subject to regulatory action, regardless of whether 
or not the bottled water bears a label statement of substandard quality 
prescribed in Sec. 165.110(c). In this regard, FDA notes that the GATT 
Agreement on Sanitary and Phytosanitary (SPS) measures, resulting from 
the Uruguay Round of Multilateral Trade Negotiations, permits countries 
to give food safety requirements priority over trade when those 
requirements are based on valid scientific information.
    4. One comment from a trade association representing bottled water 
manufacturers opposed FDA's proposal to adopt EPA's MCL for endrin as 
the allowable level in bottled water because EPA's level for endrin in 
public drinking water is higher than the existing allowable level for 
this contaminant in the bottled water quality standard. The comment 
argued that bottlers can and have met, without exception, the existing 
allowable level for endrin in bottled water, and thus, FDA should keep 
the more stringent allowable level for endrin in bottled water. The 
comment further argued that while it does not disagree with FDA's 
acknowledgment of EPA's risk assessment for contaminants, FDA should 
not weaken the bottled water quality standard merely because EPA has 
established less stringent level for public water utilities based on 
their technical limitations.
    FDA rejects the comment's call to retain the existing allowable 
level for endrin in the bottled water quality standard that is lower 
than the EPA's MCL for endrin in public drinking water. In the past, in 
similar circumstances where FDA had proposed to establish allowable 
levels for contaminants in bottled water based upon EPA's MCL's that 
were less stringent than existing allowable levels, FDA has concluded 
(see e.g. 59 FR 61529 at 61531, December 1, 1994) that its general 
policy of adopting EPA's MCL's for chemical contaminants as allowable 
levels in bottled water (where bottled water may be expected to contain 
the contaminants at issue (58 FR 41612 at 41613, August 4, 1993)) is 
appropriate because it will protect the public health, maintain 
consistent standards for identical contaminants in bottled water and 
public drinking water, prevent duplication of efforts between FDA and 
EPA in evaluating the effects of contaminants in drinking water, and 
not foster public perception that bottled water is required to be of 
better quality than tap water. This continues to be the agency's 
position. Therefore, for these reasons, FDA is adopting EPA's MCL's for 
endrin as the allowable level in the quality standard for bottled 
water.
    In conclusion, the majority of the comments to the August 1993 
proposal supported the proposed allowable levels for the 5 IOC's and 18 
SOC's in the quality standard for bottled water. Further, the agency 
has addressed the comments that suggested modifications to or were 
opposed to various allowable levels in the proposal. With the exception 
of the comment pertaining to the proposed allowable level for DEHP (see 
comment 1 of this document), none of the comments have persuaded FDA 
that it should not adopt the allowable levels as proposed for the 
remaining chemical contaminants. The agency, therefore, is adopting the 
allowable levels for 22 of the 23 chemical contaminants (excluding 
DEHP) in the quality standard for bottled water as proposed (58 FR 
41612).

C. Comments Related to Monitoring for Chemical Contaminants Under the 
Bottled Water CGMP Regulations

    5. One comment from a nonprofit private organization stated that 
laboratory equipment (e.g., inductively coupled plasma-mass 
spectroscopy (ICP-MS)) for determining a number of trace elements such 
as antimony, beryllium, and nickel) addressed in this rulemaking is not 
available to a large number of laboratories because of the cost of such 
equipment. Further, the comment maintained that a limited number of 
laboratories exist that are qualified to perform many of the methods 
that FDA is proposing to adopt for measuring these chemical 
contaminants in bottled water. Consequently, the comment asserted that 
a large number of bottlers could be in violation of monitoring 
requirements for these contaminants because laboratories qualified to 
perform the analytical methods to determine these chemical contaminants 
may not be readily available.
    FDA disagrees with this comment. In its July 1992 final rule (57 FR 
31776 at 31798), that established NPDWR's for the chemical contaminants 
addressed in this final rule, EPA stated that selection of analytical 
methods for compliance monitoring of the chemical contaminants was 
based on the following factors: (1) Reliability (i.e., precision/
accuracy) of the analytical results; (2) specificity in the presence of 
interferences; (3) availability of enough equipment and trained 
personnel to implement a national monitoring program (i.e., laboratory 
availability); (4) rapidity of analysis to permit routine use; and (5) 
cost of analysis to water supply systems.
    Further, EPA stated in its July 1992 final rule (57 FR 31776 at 
31799) that, although the ICP-MS technique for determining inorganic 
chemical contaminants (i.e., elements such as antimony, beryllium, and 
nickel) is not used widely, it expects that routine use of this 
equipment for determining trace elements in water samples will soon 
become the norm comparable to current routine laboratory use of gas 
chromatography/mass spectrometry (GC/MS) techniques for water analysis. 
In addition, EPA stated that, although the cost of the equipment is 
high, the capability of ICP-MS technique (i.e., high sensitivity, short 
analysis times, and multiple metal analytical capability) makes it a 
cost effective investment because of lower operational costs when 
compared to trace element determination with such techniques as 
conventional atomic absorption spectrophotometry. EPA concluded that 
the ICP-MS technique is technologically and economically feasible for 
routine compliance monitoring of water samples and adopted the 
technique for determining trace elements in water samples. Finally, EPA 
stated that the ICP-MS technique is one of many being approved for 
determining trace elements in water samples, and laboratories without 
ICP-MS technique capability may use other conventional methods.
    Based on the factors discussed above (i.e., reliability, 
specificity, availability, rapidity) that EPA considered in adopting 
analytical methods for determining the levels in public drinking water 
of the 24 chemical contaminants that are the subject of this 
rulemaking, FDA concludes that

[[Page 13261]]
laboratories are readily available that are competent in performing the 
applicable analytical methods for the 22 chemical contaminants for 
which it is establishing allowable levels. FDA therefore rejects the 
comment's suggestion that a large number of bottlers could be in 
violation of the monitoring requirements for a number of the 
contaminants because laboratories qualified to perform the required 
analytical methods are not readily available.
    6. Comments from a trade association representing bottled water 
manufacturers and from a nonprofit private organization maintained 
that, for nine of the chemical contaminants addressed in the proposal, 
namely the IOC's antimony, beryllium, cyanide, nickel, and thallium and 
the SOC's diquat, endothall, glyphosate, and dioxin, finalization of 
the proposed allowable levels would, under the CGMP requirements for 
bottled water (part 129), require additional analytical testing to be 
performed by water bottlers for monitoring purposes. Bottlers would 
have to test for these contaminants at least annually using methods 
other than those that are being used to analyze bottled water for 
compliance with the quality standard. The comment from the bottled 
water trade association stated that this additional testing would 
impose an additional cost of over one million dollars annually on 
bottlers. To ease the economic burden that would result from these 
testing requirements, the comments recommended that the agency adopt 
monitoring requirements for bottled water that are similar to EPA's 
monitoring requirements, which would allow bottlers to obtain waivers 
permitting them to monitor finished bottled water products for chemical 
contaminants less frequently than once per year if they can establish 
that a contaminant is not likely to be present in the source water for 
bottling or in the finished bottled water products.
    However, comments from two State public health departments 
contended that water bottlers should continue to be required to test 
their products at least annually for chemical contaminants. One of 
these comments argued that the current minimum annual testing is 
essential, and that cost should not be a consideration, even for small 
bottling companies.
    FDA recognizes that the number of chemical contaminants that 
bottlers must monitor under the bottled water CGMP regulations has 
increased substantially in recent years. FDA also recognizes that the 
increased monitoring requirements pose additional costs to water 
bottlers. Further, data submitted by one commenter that was obtained 
from a nonprofit private organization that offers testing services for 
the bottled water industry suggest that bottled water frequently would 
not be expected to contain detectable levels of the types of 
nonnaturally occurring contaminants regulated under the bottled water 
quality standard (i.e., pesticides and SOC's), and that the instances 
where such chemicals are detected are relatively few in number. 
Moreover, the levels of such contaminants, when found, are well below 
the allowable levels. The data also suggest that naturally occurring 
contaminants, e.g., IOC's, are frequently not found in bottled water, 
and that when they are found in bottled water, they do not exceed the 
allowable levels and, in fact, are usually found at levels well below 
the allowable levels.
    For example, a 1990 analytical test summary showed that among a set 
of 97 bottled water products analyzed for 6 pesticide chemicals 
(endrin, lindane, methoxychlor, toxaphene, 2,4-D, and 2,4,5-TP), none 
tested positive for any of these 6 pesticide chemicals, i.e., no 
pesticide chemical was detected in 582 (i.e., 6 x 97) analyses. The 
analytical test summary also showed that among another set of 21 
bottled water products analyzed for 11 different pesticide chemicals 
(simazine, atrazine, alachlor, heptachlor, chlordane, oxamyl, 
carbofuran, dalapon, pentachlorophenol, dinoseb, and picloram), none 
tested positive for any of these 11 pesticide chemicals, i.e., no 
pesticide chemical was detected in the 231 (i.e., 11 x 21) analyses. 
Further, in 1993, among 150 bottled water samples analyzed for the 
above 17 pesticide chemicals for which EPA has established MCL's, none 
showed the presence of any of these 17 pesticide chemicals, i.e., no 
pesticide chemical was detected in the 2,550 (i.e., 17 x 150) analyses.
    In addition, the commenter submitted another 1990 analytical 
summary showing that among 97 bottled water products tested for 32 
contaminants (18 IOC's, 11 nonpesticide SOC's, and 3 physical/quality 
attributes) for which FDA has established allowable levels in the 
bottled water quality standard, none contained any of these 
contaminants above the allowable levels. Nonpesticide SOC's were 
detected in 70 instances among the 1,067 (i.e., 11 x 97) analyses, but 
in no case did the level detected exceed 20 percent of the allowable 
level. Further, when testing was done for other types of contaminants 
(IOC's) and physical/quality attributes (e.g., odor, turbidity), such 
contaminants were not detected in 76 percent (i.e., 1,554 of 2,037) of 
the analyses, and in no case did a contaminant exceed the allowable 
level. Contaminants exceeding 50 percent of the allowable level were 
detected in only 12 instances among 2,037 analyses, and in all but 1 of 
these instances, the contaminants or physical/quality attributes that 
were detected (e.g., color, odor, TDS, iron, manganese) were those for 
which FDA has established allowable levels based on EPA's SMCL's to 
address the aesthetic effects, but not the health effects, of the 
contaminants. Contaminants exceeding 20 percent of the allowable level 
were detected in 100 instances among the 2,037 analyses, and in all but 
6 of these instances, the contaminants or physical/quality attributes 
detected were those for which FDA has established allowable levels 
based on EPA's SMCL's.
    In view of these facts, the commenter's suggestion that FDA adopt 
monitoring requirements for bottled water that are similar to EPA's 
monitoring requirements (i.e., that would allow bottlers to monitor 
finished bottled water products for chemical contaminants less 
frequently than once per year if they can establish that a contaminant 
is not likely to be present in the source water for bottling or in the 
finished bottled water products) merits consideration by the agency. 
However, any revision of the monitoring requirements for chemical 
contaminants in bottled water would require a careful consideration of 
all the relevant facts and an opportunity for input from all concerned 
parties. It would also require an amendment of the bottled water CGMP 
regulations. As such, it is beyond the scope of this rulemaking. This 
rulemaking only addresses the allowable levels for certain chemical 
contaminants in the quality standard for bottled water.
    FDA intends to initiate rulemaking to address the issue of the 
circumstances in which reduced frequency of monitoring for chemical 
contaminants in bottled water products is appropriate. This rulemaking 
will consider the issues raised in the comments from the State health 
department summarized above. However, the agency's ability to undertake 
this rulemaking expeditiously will depend on the availability of agency 
resources and other competing priorities, particularly those of a 
significant public health concern.
    As discussed above, FDA is adopting the allowable levels for 22 of 
23 chemical contaminants (excluding DEHP) in the quality standard for 
bottled water as proposed (58 FR 41612). However, given the cost of 
testing for the nine chemical

[[Page 13262]]
contaminants in question (antimony, beryllium, cyanide, nickel, 
thallium, diquat, endothall, glyphosate, and dioxin), and the fact that 
the comments have submitted data showing that it is unlikely that 
IOC's, SOC's, and pesticide contaminants will be found in bottled water 
at levels that would pose a quality or safety concern, FDA finds that 
it is in the public interest and in the interest of justice to stay the 
effective date of the allowable levels for these nine comtaminants, in 
accordance with 21 CFR 10.35(e). FDA is staying the effect of these 
allowable levels until it has completed a rulemaking to address the 
issue of reduced frequency monitoring for chemical contaminants in 
bottled water. As a result of this action, bottlers are not required to 
monitor source waters and finished bottled water products annually for 
these nine chemical contaminants at this time.
    FDA, however, reminds water bottlers that they are responsible for 
ensuring that all bottled water products introduced or delivered for 
introduction into interstate commerce are safe, wholesome, and 
appropriately labeled. Moreover, any bottled water containing any 
substance (including any of the nine chemical contaminants for which 
the allowable levels are being stayed) at a level that may be injurious 
to health under section 402 of the act is adulterated and will be 
subject to regulatory action. Consequently, FDA advises water bottlers 
to ensure through appropriate manufacturing techniques and sufficient 
quality control procedures that their bottled water products are safe 
with respect to levels of these nine chemical contaminants.

III. Conclusion

    The agency is adopting the provisions concerning allowable levels 
for 22 of the 23 chemical contaminants (excluding DEHP) in the quality 
standard for bottled water as proposed (58 FR 41612). However, FDA is 
staying the effective date of the allowable levels for nine of these 
chemical contaminants (five IOC's and four SOC's) for the reasons 
explained in the response to comment 6 of this document. Further, as 
explained in response to comment 1 of this document, FDA is deferring 
final action on the proposed allowable level for the nonpesticide 
chemical DEHP.
    The majority of the comments to the August 1993 proposal supported 
the provisions concerning allowable levels that FDA is adopting in this 
final rule. Further, after carefully considering the comments that the 
agency received that suggested modifications to, or that were opposed 
to, various provisions of the proposal, the agency has determined that 
no changes in the final rule other than those discussed in the response 
to comment 6 of this document concerning staying of the effective date 
for 9 of the 23 contaminants and in response to comment 1 of this 
document concerning deferring final action on DEHP are warranted.
    In the November 1995 final rule that established a standard of 
identity for bottled water, FDA moved the standard of quality for 
bottled water from Sec. 103.35 (21 CFR 103.35) to Sec. 165.110. 
Therefore, the provisions that are being added to the quality standard 
in this final rule are being codified under Sec. 165.110 and not under 
Sec. 103.35 (as was proposed), which has been superseded.
    With respect analytical methods for the determination of chemical 
contaminants, FDA is making the following changes in 
165.110(b)(4)(iii).
    In Sec. 165.110(b)(4)(iii)(E)(1)(iv), FDA cites the updated version 
of proposed Method D-3697-87 (i.e., Method D-3697-92), and in 
Sec. 165.110(b)(4)(iii)(E)(7)(iv), FDA cites the updated version of 
proposed Method D-2036-89A (i.e., Method D-2036-91).
    These methods are contained in the manual entitled ``Annual Book of 
ASTM Standards,'' vols. 11.01 and 11.02, 1995, American Society for 
Testing and Materials (ASTM), 100 Barr Harbor Dr., West Conshoocken, PA 
19428, which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51. The source for the manual containing the two 
methods is the American Society for Testing and Materials. FDA is 
adopting the updated versions of the two methods because the proposed 
older versions (i.e., Method D-3697-87 and Method D-2036-89A) are 
contained in the 1991 edition of the manual entitled ``Annual Book of 
ASTM Standards,'' vols. 11.01 and 11.02, which the publisher has 
discontinued printing, and therefore, is no longer commercially 
available.
    Further, FDA is deleting proposed Sec. 103.35(d)(3)(v)(H)(5) that 
contains the analytical method, 4500-CN-F which is one of five methods 
that FDA proposed to adopt for determining cyanide in bottled water. 
FDA proposed to adopt Method 4500-CN-F that is contained in ``Standard 
Methods for the Examination of Water and Wastewater,'' 17th ed. (1989), 
published by the American Public Health Association, Washington, DC. 
However, the publisher has discontinued printing the 1989 edition of 
the Standard Methods for the Examination of Water and Wastewater. 
Consequently, the 1989 version of Method 4500-CN-F is no longer 
commercially available. Therefore, because the 1989 version of Method 
4500-CN-F is no longer commercially available, and because FDA is 
incorporating by reference four other methods (three EPA methods and 
one ASTM method) for determining cyanide in bottled water, FDA is not 
adopting Method 4500-CN-F.
    Finally, FDA is consolidating and relisting in alphabetical order 
all of the appropriate analytical methods that the agency either 
previously incorporated by reference or is incorporating by reference 
in this final rule in recodified Sec. 165.110(b)(4)(iii)(E), 
(b)(4)(iii)(F), and (b)(4)(iii)(G).
    Therefore, upon the effective date of this rule, September 23, 
1996, any bottled water that contains any of the 13 chemical 
contaminants for which the allowable levels are effective at a level 
that exceeds the applicable allowable levels will be misbranded under 
section 403(h)(1) of the act (21 U.S.C. 343(h)(1)) unless it bears a 
statement of substandard quality as provided by Sec. 165.110(c)(3).

IV. Environmental Impact

    The agency has previously considered the environmental effects of 
this rule as announced in the proposed rule (58 FR 41612, August 4, 
1993). No new information or comments have been received 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 Economic Impacts

    FDA has examined the impacts of this final rule which amends the 
quality standard for bottled water by establishing or revising 
allowable levels for 5 IOC's and 17 SOC's (excluding DEHP) as required 
by Executive Order 12866 and the Regulatory Flexibility Act (Pub. L. 
96-654). 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 Regulatory Flexibility Act requires analyzing options for 
regulatory relief for small businesses. FDA finds that this final rule 
is not a significant regulatory action as defined by Executive Order 
12866. In compliance with the Regulatory Flexibility Act, the agency 
certifies that the final rule will

[[Page 13263]]
not have a significant impact on a substantial number of small 
businesses.

A. Costs

    In the August 1993 proposal, FDA presented an analysis of the 
economic impact of the proposed requirements under the previous 
Executive Order 12291. In that analysis, the agency stated that the 
benefits of the proposed rule are expected to be zero because none of 
the 23 chemicals found in currently marketed bottled water are expected 
to be above the levels of the proposed standard. FDA also stated that 
the costs of this regulation will only be for testing of these 
chemicals according to the CGMP regulations for bottled water. A single 
test can be used to simultaneously analyze a number of chemicals and 
can cost up to $3,000 per sample. To the extent that the tests 
currently being performed can be used to test for any of the 23 
chemicals, there would be no additional costs imposed by this rule.
    As mentioned above, in response to that analysis the agency 
received two comments, one from a trade association representing 
bottled water manufacturers and one from a nonprofit private 
organization. One of the comments stated that, under the proposal, 14 
contaminants may be analyzed using methods that can simultaneously test 
for a number of currently regulated chemicals, and that no additional 
testing cost would be required. However, the other nine of these 
chemicals would require additional testing, which would increase costs 
for each bottled water product by $1,290 per sample, and by another 
$1,290 for each nonmunicipal source. In the United States there are 
1,000 to 1,100 bottled water products that under the proposed 
requirements would require additional testing (Ref. 1). The incremental 
annual costs to bottlers would then range between $1.29 to $1.419 
million for additional testing of the finished bottled water products 
(i.e., $1,290 x 1,000 to 1,100 bottled water products). The number of 
nonmunicipal sources affected is not known, but assuming that, on 
average, 50 percent of the total bottled water products are from 
nonmunicipal sources, the cost of the additional testing would be 
$1,290  x  500 nonmunicipal sources or $645,000 annually. The total 
annual costs of additional testing would be approximately $2 million.
    According to a trade association comment, approximately 140 of 
their member bottlers are considered small or have sales that are below 
$1 million. These 140 small bottlers represent approximately half of 
the small bottlers in the country (Ref. 1). On average, each small 
bottler produces two products. Thus the incremental annual cost to 
small bottlers is estimated as 280 bottlers  x  2 products  x  $1,290, 
which would be equal to $722,400. The total future discounted costs (6 
percent) to small businesses would be $12 million.
    In addition, as mentioned above (see response to comment 6 of this 
document, supra), 1990 and 1993 data from a nonprofit private 
organization that offers testing services for the bottled water 
industry suggest that bottled water frequently may not be expected to 
contain detectable levels of the types of nonnaturally occurring 
contaminants regulated under the bottled water quality standard (e.g., 
pesticides and SOC's), and that the instances where such chemicals may 
be detected are relatively few in number. The data also show that the 
levels of such contaminants, when found, are well below the allowable 
levels. FDA has also received data that suggest that some types of 
contaminants, e.g., IOC's, are frequently not found in bottled water 
and, when found in bottled water, do not exceed the allowable levels 
and are usually found at levels well below the allowable levels. For 
these reasons, the comment suggested that FDA provide waivers similar 
to those provided by EPA that would allow less frequent monitoring of 
contaminants not likely to be found in bottled water. Although this 
suggestion warrants consideration by the agency, any revision of the 
monitoring requirements for chemical contaminants in bottled water 
would require amending the bottled water CGMP regulations. An amendment 
of CGMP regulations is beyond the scope of this rulemaking.
    As mentioned earlier, FDA intends to initiate rulemaking to address 
the issue of reduced frequency monitoring for chemicals that are 
unlikely to be present in bottled water. However, the agency's ability 
to undertake such rulemaking expeditiously will depend on the 
availability of agency resources and other competing priorities, 
particularly for those that pose significant public health concerns. 
Therefore, as explained above, FDA decided to finalize the allowable 
levels for the nine contaminants that cannot be analyzed with currently 
used methods but to stay the effective date for these allowable levels 
until it undertakes a rulemaking on reduced frequency monitoring for 
chemical contaminants in bottled water. Thus, while stayed, this rule 
results in no additional testing costs for these nine contaminants.
    To assess the minimum expected cost of this rule if the monitoring 
frequency requirements in the CGMP are reduced, FDA assumes that any 
revision of the CGMP would require at least initial testing for the 
nine contaminants for which the allowable levels are being stayed. The 
cost for this initial testing for 1,000 to 1,100 bottled water products 
and 500 nonmunicipal sources would be approximately $2 million as 
stated above. This is the minimum expected cost since additional 
testing (at less frequent intervals) still would be required after the 
initial testing. No reformulation costs are expected because none of 
the 23 contaminants are found in bottled water above the levels of the 
proposed standard.

B. Benefits

    In the Economic Impact Analysis of the proposed rule FDA determined 
that, because none of the 23 contaminants are expected to be found in 
bottled water above the levels of the standards, benefits of the 
proposed rule were expected to be zero. However, this rule ensures 
that, should current conditions change, such as new sources of water or 
new manufacturing practices, the level of these contaminants will 
remain low. Although the health benefits of this regulation are 
expected to be small, regulation similar to that for municipal water 
may improve consumer perceptions of the risk associated with bottled 
water, particularly relative to municipal water.

VI. Reference

    The following reference has been place on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20875, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

    1. Memorandum of telephone conversation to Tyrone Wilson of the 
International Bottled Water Association (IBWA), from Christinia 
Ford, (FDA), September 7, 1995.

List of Subjects in 21 CFR Part 165

    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 
165 is amended as follows:

PART 165--BEVERAGES

    1. The authority citation for 21 CFR part 165 continues to read as 
follows:

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


[[Page 13264]]

    2. Section 165.110 is amended in the table in paragraph 
(b)(4)(i)(A) by removing the entries for ``Sulfate'' and ``Endrin * * 
*'', by alphabetically adding new entries in the tables in paragraphs 
(b)(4)(iii)(A), (b)(4)(iii)(B), (b)(4)(iii)(C), and (b)(4)(iii)(D), and 
by revising paragraphs (b)(4)(iii)(E), (b)(4)(iii)(F), and 
(b)(4)(iii)(G) to read as follows:


Sec. 165.110  Bottled water.

* * * * *
    (b) * * *
    (4) * * *
    (iii) * * *
    (A) * * *

------------------------------------------------------------------------
                                                        Concentration in
                                                         milligrams per 
                      Contaminant                         liter (or as  
                                                           specified)   
------------------------------------------------------------------------
Antimony \1\..........................................          .006    
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Beryllium \1\.........................................         0.004    
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Cyanide \1\...........................................         0.2      
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Nickel \1\............................................         0.1      
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Thallium \1\..........................................         0.002    
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
------------------------------------------------------------------------
\1\ Stayed until further notice. See Sec.  165.110(b)(4)(iii)           
  (G)(3)(iv).                                                           

    (B) * * *

------------------------------------------------------------------------
                                                        Concentration in
              Contaminant (CAS Reg. No.)                 milligrams per 
                                                              liter     
------------------------------------------------------------------------
                                                                        
*                  *                  *                  *              
Dichloromethane (75-09-2).............................         0.005    
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
1,2,4-Trichlorobenzene (120-82-1).....................         0.07     
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
1,1,2-Trichloroethane (79-00-5).......................         0.005    
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
------------------------------------------------------------------------

    (C) * * *

------------------------------------------------------------------------
                                                           Concentration
                Contaminant (CAS Reg. No.)                 in milligrams
                                                             per liter  
------------------------------------------------------------------------
                                                                        
*                  *                  *                  *              
Benzo(a)pyrene (50-32-8).................................         0.0002
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Dalapon (75-99-0)........................................         0.2   
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Di(2-ethylhexyl)adipate (103-23-1).......................         0.4   
Dinoseb (88-85-7)........................................         0.007 
Diquat (85-00-7)\1\......................................         0.02  
Endothall (145-73-3) \1\.................................         0.1   
Endrin (72-20-8).........................................         0.002 
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Glyphosate (1071-53-6) \1\...............................         0.7   
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Hexachlorobenzene (118-74-4).............................         0.001 
Hexachlorocyclopentadiene (77-47-4)......................         0.05  

[[Page 13265]]
                                                                        
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Oxamyl (23135-22-0)......................................         0.2   
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
Picloram (1918-02-1).....................................         0.5   
Simazine (122-34-9)......................................         0.004 
2,3,7,8-TCDD (Dioxin) (1746-01-6) \1\....................  3 x 10-8     
                                                                        
*                  *                  *                  *              
                  *                  *                  *               
------------------------------------------------------------------------
\1\ Stayed until further notice. See Sec.  165.110(b)(4)(iii)           
  (G)(3)(iv).                                                           


    (D) * * *

------------------------------------------------------------------------
                                                           Concentration
                       Contaminant                         in milligrams
                                                             per liter  
------------------------------------------------------------------------
                                                                        
*                  *                  *                  *              
Sulfate \1\..............................................        250.0  
------------------------------------------------------------------------
\1\ Mineral water is exempt from allowable level. The exemptions are    
  aesthetically based allowable levels and do not relate to a health    
  concern.                                                              

    (E) Analyses to determine compliance with the requirements of 
paragraph (b)(4)(iii)(A) of this section shall be conducted in 
accordance with an applicable method and applicable revisions to the 
methods listed in paragraphs (b)(4)(iii)(E)(1) through 
(b)(4)(iii)(E)(13) 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 (EMSL), Cincinnati, 
OH 45258 (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 (NTIS), U.S. Department of Commerce, 5825 Port 
Royal Rd., Springfield, VA 22161, or may be examined at the Center for 
Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 200 C Street SW., Washington, DC 20204, or at the 
Office of the Federal Register, 800 North Capitol Street NW., suite 
700, Washington, DC.
    (1) Antimony shall be measured using the following methods:
    (i) Method 204.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 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,'' 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 Center for Food Safety and Applied 
Nutrition's Library, Food and Drug Administration, 200 C Street SW., 
Washington, DC 20204, or at the Office of the Federal Register, 800 
North Capitol Street NW., suite 700, Washington, DC.
    (iii) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 
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,'' 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method D-3697-92--``Standard Test Method for Antimony in 
Water,'' contained in the Annual Book of ASTM Standards, vols. 11.01 
and 11.02, 1995, American Society for Testing and Materials, 100 Barr 
Harbor Dr., West Conshohocken, PA 19428, 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 American Society for Testing and 
Materials, 100 Barr Harbor Dr., West Conshohocken, PA 19428, or may be 
examined at the Center for Food Safety and Applied Nutrition's Library, 
Food and Drug Administration, 200 C Street SW., Washington, DC 20204, 
or at the Office of the Federal Register, 800 North Capitol Street NW., 
suite 700, Washington, DC.
    (2) Barium shall be measured using the following methods:
    (i) Method 208.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (ii) Method 208.1--``Atomic Absorption; direct aspiration,'' 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 (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, EMSL. The revision is 
contained in the manual entitled ``Methods for the Determination of 
Metals in Environmental Samples,''

[[Page 13266]]
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. The availability of this 
incorporation by reference is given in paragraph (b)(4)(iii)(E)(1)(ii) 
of this section.
    (3) Beryllium shall be measured using the following methods:
    (i) Method 210.2--``Atomic Absorption; Furnace Technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (iii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 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,'' 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 
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,'' 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (4) Cadmium shall be measured using the following methods:
    (i) Method 213.2--``Atomic Absorption; Furnace Technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (5) Chromium shall be measured using the following methods:
    (1) Method 218.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (2) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (6) Copper shall be measured as total recoverable metal without 
filtration using the following methods:
    (i) Method 220.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (ii) Method 220.1--``Atomic Absorption; direct aspiration,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. The availability of these incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 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,'' 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 
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,'' 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (7) Cyanide shall be measured using the following methods:
    (i) Method 335.1--``Titrimetric; Spectrophotometric'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 335.2--``Titrimetric; Spectrophotometric'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (iii) Method 335.3--``Colorimetric, Automated UV,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of these incorporation by reference is given 
in paragraph (b)(4)(iii)(E) of this section.
    (iv) Method D-2036-91--``Standard Test Methods for Cyanides in 
Water,'' contained in the Annual Book of ASTM Standards, vols. 11.01 
and 11.02, 1995, American Society for Testing and Materials, 100 Barr 
Harbor Dr., West Conshohocken, PA 19428, 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

[[Page 13267]]
from American Society for Testing and Materials, 100 Barr Harbor Dr., 
West Conshohocken, PA 19428, or may be examined at the Center for Food 
Safety and Applied Nutrition's Library, 200 C Street SW., Washington, 
DC 20204, or at the Office of the Federal Register, 800 North Capitol 
Street NW., suite 700, Washington, DC.
    (8) Lead shall be measured as total recoverable metal without 
filtration using the following methods:
    (i) Method 239.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 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,'' 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iii) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 
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,'' 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (9) Mercury shall be measured using the following methods:
    (i) Method 245.1--``Manual cold vapor technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (ii) Method 245.2--``Automated cold vapor technique,'' which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of these incorporation by reference is given 
in paragraph (b)(4)(iii)(E) of this section.
    (10) Nickel shall be measured using the following methods:
    (i) Method 249.1--``Atomic Absorption; direct aspiration,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (ii) Method 249.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51. The availability of these incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Metals and Trace Elements in 
Water and Wastes by Inductively Coupled Plasma-Atomic Emission 
Spectrometry,'' Rev. 3.3, April 1991, U.S. EPA, 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 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,'' 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 
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,'' 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (11) Nitrate and/or nitrite shall be measured using the following 
methods:
    (i) Method 300.0--``The Determination of Inorganic Anions in Water 
by Ion Chromatography--Method 300.0,'' EPA, EMSL (EPA-600/4-84-017), 
March 1984, 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 NTIS, U.S. Department of Commerce, 5825 Port Royal Rd., 
Springfield, VA 22161, or may be examined at the Center for Food Safety 
and Applied Nutrition's Library, Food and Drug Administration, 200 C 
Street SW., Washington, DC 20204, or at the Office of the Federal 
Register, 800 North Capitol Street NW., suite 700, Washington, DC.
    (ii) Method 353.1--``Colorimetric, automated, hydrazine 
reduction,'' for nitrate only, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (iii) Method 353.2--``Colorimetric, automated, cadmium reduction,'' 
for both nitrate and nitrite, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (iv) Method 353.3--``Spectrophotometric, cadmium reduction,'' for 
both nitrate and nitrite, which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (12) Selenium shall be measured using the following methods:
    (i) Method 270.2--``Atomic Absorption; furnace technique,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (ii) Method 270.3--``Atomic Absorption; gaseous hydride,'' 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 (b)(4)(iii)(E) of this section.
    (13) Thallium shall be measured using the following methods:
    (i) Method 279.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (ii) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 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,'' 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (iii) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 
1.2, April 1991, U.S. EPA, EMSL. The revision is contained in the 
manual

[[Page 13268]]
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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (F) Analyses to determine compliance with the requirements of 
paragraphs (b)(4)(iii)(B) and (b)(4)(iii)(C) of this section shall be 
conducted in accordance with an applicable method or applicable 
revisions to the methods listed in paragraphs (b)(4)(iii)(F)(1) through 
(b)(4)(iii)(F)(20) of this section and described, unless otherwise 
noted, in ``Methods for the Determination of Organic Compounds in 
Drinking Water,'' Office of Research and Development, EMSL, EPA/600/4-
88/039, December 1988, or in ``Methods for the Determination of Organic 
Compounds in Drinking Water, Supplement 1,'' Office of Research and 
Development, EMSL, EPA/600/4-90/020, July 1990, which are incorporated 
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. 
Copies of these publications are available from NTIS, U.S. Department 
of Commerce, 5285 Port Royal Rd., Springfield, VA 22161, or may be 
examined at the Center for Food Safety and Applied Nutrition's Library, 
Food and Drug Administration, 200 C St. SW., Washington, DC, or at the 
Office of the Federal Register, 800 North Capitol St. NW., suite 700, 
Washington, DC.
    (1) Method 502.1--``Volatile Halogenated Organic Compounds in Water 
by Purge and Trap Gas Chromatography,'' Rev. 2.0, 1989, (applicable to 
VOC's), which is incorporated by reference in accordance with 5 U.S.C. 
552(a) and 1 CFR part 51, or
    (2) Method 502.2--``Volatile Organic Compounds in Water by Purge 
and Trap Capillary Column Gas Chromatography with Photoionization and 
Electrolytic Conductivity Detectors in Series,'' Rev. 2.0, 1989, 
(applicable to VOC's), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (3) Method 503.1--``Volatile Aromatic and Unsaturated Organic 
Compounds in Water by Purge and Trap Gas Chromatography,'' Rev. 2.0, 
1989, (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (4) Method 524.1--``Measurement of Purgeable Organic Compounds in 
Water by Packed Column Gas Chromatography/Mass Spectrometry,'' Rev. 
3.0, 1989, (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (5) Method 524.2--``Measurement of Purgeable Organic Compounds in 
Water by Capillary Column Gas Chromatography/Mass Spectrometry,'' Rev. 
3.0, 1989, (applicable to VOC's), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (6) Method 504--``1,2-Dibromoethane (EDB) and 1,2-Dibromo-3- 
Chloropropane (DBCP) in Water by Microextraction and Gas 
Chromatography,'' Rev. 2.0, 1989, (applicable to dibromochloropropane 
(DBCP) and ethylene dibromide (EDB)), which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (7) Method 505--``Analysis of Organohalide Pesticides and 
Commercial Polychlorinated Biphenyl (PCB) Products in Water by 
Microextraction and Gas Chromatography,'' Rev. 2.0, 1989, (applicable 
to alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, 
lindane, methoxychlor, toxaphene, endrin, hexachlorobenzene, 
hexachlorocyclopentadiene, simazine, and as a screen for PCB's), which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (8) Method 506--``Determination of Phthalate and Adipate Esters in 
Drinking Water by Liquid-Liquid Extraction or Liquid-Solid Extraction 
and Gas Chromatography with Photoionization Detection,'' applicable to 
di(2-ethylhexyl) adipate which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (9) Method 507--``Determination of Nitrogen- and Phosphorus-
Containing Pesticides in Water by Gas Chromatography with a Nitrogen-
Phosphorus Detector,'' Rev. 2.0, 1989, (applicable to alachlor, 
atrazine, and simazine), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (10) Method 508--``Determination of Chlorinated Pesticides in Water 
by Gas Chromatography with an Electron Capture Detector,'' Rev. 3.0, 
1989, (applicable to chlordane, heptachlor, heptachlor epoxide, 
lindane, methoxychlor, toxaphene, endrin, hexachlorobenzene, and as a 
screen for PCB's), which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (11) Method 508A--``Screening for Polychlorinated Biphenyls by 
Perchlorination and Gas Chromatography,'' Rev. 1.0, 1989, (used to 
quantitate PCB's as decachlorobiphenyl if detected in methods 505 or 
508 in paragraph (b)(4)(iii)(F)(7) or (b)(4)(iii)(F)(9) of this 
section, respectively, which is incorporated by reference in accordance 
with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (12) Method 515.1--``Determination of Chlorinated Acids in Water by 
Gas Chromatography with an Electron Capture Detector,'' Rev. 5.0, 1991, 
(applicable to 2,4-D, 2,4,5-TP (Silvex), pentachlorophenol, dalapon, 
dinoseb, and picloram), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (13) Method 525.1--``Determination of Organic Compounds in Drinking 
Water by Liquid-Solid Extraction and Capillary Column Gas 
Chromatography/Mass Spectrometry,'' Rev. 2.2, May 1991, (applicable to 
alachlor, atrazine, chlordane, heptachlor, heptachlor epoxide, lindane, 
methoxychlor, pentachlorophenol, benzo(a)pyrene, di(2-ethylhexyl) 
adipate, endrin, hexachlorobenzene, hexachlorocyclopentadiene, and 
simazine), which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (14) Method 531.1--``Measurement of N-Methylcarbamoyloximes and N-
Methylcarbamates in Water by Direct Aqueous Injection HPLC with Post 
Column Derivatization,'' Rev. 3.0, 1989, (applicable to carbofuran and 
oxamyl (vydate)), which is incorporated by reference in accordance with 
5 U.S.C. 552(a) and 1 CFR part 51, or
    (15) Method 547--``Determination of Glyphosate in Drinking Water by 
Direct-Aqueous-Injection HPLC, Post-Column Derivatization, and 
Fluorescence Detection,'' (applicable to glyphosate), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (16) Method 548--``Determination of Endothall in Drinking Water by 
Aqueous Derivatization, Liquid-Solid Extraction, and Gas Chromatography 
with Electron-Capture Detection,'' (applicable to endothall), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (17) Method 549--``Determination of Diquat and Paraquat in Drinking 
Water by Liquid-Solid Extraction and HPLC with Ultraviolet Detection,'' 
(applicable to diquat), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or

[[Page 13269]]

    (18) Method 550--``Determination of Polycyclic Aromatic 
Hydrocarbons in Drinking Water by Liquid-Liquid Extraction and HPLC 
with Coupled Ultraviolet and Fluorescence Detection,'' (applicable to 
benzo(a)pyrene and other polynuclear aromatic hydrocarbons), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51, or
    (19) Method 550.1--``Determination of Polycyclic Aromatic 
Hydrocarbons in Drinking Water by Liquid-Solid Extraction and HPLC with 
Coupled Ultraviolet and Fluorescence Detection,'' (applicable to 
benzo(a)pyrene and other polynuclear aromatic hydrocarbons), which is 
incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. The availability of these incorporation by reference is given 
in paragraph (b)(4)(iii)(F) of this section.
    (20) Method 1613--``Tetra- through Octa- Chlorinated Dioxins and 
Furans by Isotope Dilution HRGC/HRMS,'' Rev. A, 1990, EPA, Office of 
Water Regulations and Standards, Industrial Technology Division, 
(applicable to 2,3,7,8-TCDD (Dioxin)), 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 USEPA-OST, Sample Control 
Center, P.O. Box 1407, Alexandria, VA 22313, or may be examined at the 
Center for Food Safety and Applied Nutrition's Library, Food and Drug 
Administration, 200 C St. SW., Washington, DC, or at the Office of the 
Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.
    (G) Analyses to determine compliance with the requirements of 
paragraph (b)(4)(iii)(D) of this section shall be conducted in 
accordance with an applicable method and applicable revisions to the 
methods listed in paragraphs (b)(4)(iii)(G)(1) through 
(b)(4)(iii)(G)(3) of this section and described, unless otherwise 
noted, in ``Methods of 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 (b)(4)(iii)(E) of this section.
    (1) Aluminum shall be measured using the following methods:
    (i) Method 202.1--``Atomic Absorption; direct aspiration 
technique,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (ii) Method 202.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E).
    (iii) Method 200.7--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,'' 
Rev. 3.3, April 1991, U.S. EPA, 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 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,'' 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 
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,'' 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (2) Silver shall be measured using the following methods:
    (i) Method 272.1--``Atomic Absorption; direct aspiration 
technique,'' which is incorporated by reference in accordance with 5 
U.S.C. 552(a) and 1 CFR part 51, or
    (ii) Method 272.2--``Atomic Absorption; furnace technique,'' 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 (b)(4)(iii)(E) of this section.
    (iii) Method 200.7--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Atomic Emission Spectrometry,'' 
Rev. 3.3, April 1991, U.S. EPA, 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. The availability of this incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (iv) Method 200.8--``Determination of Trace Elements in Water and 
Wastes by Inductively Coupled Plasma-Mass Spectrometry,'' Rev. 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,'' 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. The availability of 
this incorporation by reference is given in paragraph 
(b)(4)(iii)(E)(1)(ii) of this section.
    (v) Method 200.9--``Determination of Trace Elements by Stabilized 
Temperature Graphite Furnace Atomic Absorption Spectrometry,'' Rev. 
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,'' 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. The availability of these incorporation by reference is given 
in paragraph (b)(4)(iii)(E)(1)(ii) of this section.
    (3) Sulfate shall be measured using the following methods:
    (i) Method 300.0--``The Determination of Inorganic Anions in Water 
by Ion Chromatography--Method 300.0,'' EPA, EMSL (EPA-600/4-84-017), 
March 1984, 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 (b)(4)(iii)(E)(11)(i) of this 
section.
    (ii) Method 375.1--``Colorimetric, Automated, Chloranilate,'' which 
is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 
CFR part 51, or
    (iii) Method 375.3--``Gravimetric,'' which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, or
    (iv) Method 375.4--``Turbidimetric,'' which is incorporated by 
reference in accordance with 5 U.S.C. 552(a) and 1

[[Page 13270]]
CFR part 51. The availability of these incorporation by reference is 
given in paragraph (b)(4)(iii)(E) of this section.

[Note: the allowable levels in Sec. 165.110 for the chemicals 
antimony, beryllium, cyanide, nickel, thallium, diquat, endothall, 
glyphosate, and dioxin are stayed until further notice.]
* * * * * *
    Dated: March 18, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-6940 Filed 3-25-96; 8:45 am]
BILLING CODE 4160-01-P