[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]]
_______________________________________________________________________
Part III
Department of Health and Human Services
_______________________________________________________________________
Food and Drug Administration
_______________________________________________________________________
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.
-----------------------------------------------------------------------
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
