Beverages: Bottled Water Quality Standard; Establishing an Allowable Level for di(2-ethylhexyl)phthalate, 64810-64813 [2011-26707]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Rules and Regulations]
[Pages 64810-64813]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26707]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 165

[Docket No. FDA 1993-N-0259 (Formerly Docket No. 1993N-0085)]


Beverages: Bottled Water Quality Standard; Establishing an 
Allowable Level for di(2-ethylhexyl)phthalate

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its bottled 
water quality standard regulations by establishing an allowable level 
for the chemical di(2-ethylhexyl)phthalate (DEHP). As a consequence, 
bottled water manufacturers are required to monitor their finished 
bottled water products for DEHP at least once each year under the 
current good manufacturing practice (CGMP) regulations for bottled 
water. Bottled water manufacturers are also required to monitor their 
source water for DEHP as often as necessary, but at least once every 
year unless they meet the criteria for source water monitoring 
exemptions under the CGMP regulations. This final rule will ensure that 
FDA's standards for the minimum quality of bottled water, as affected 
by DEHP, will be no less protective of the public health than those set 
by the Environmental Protection Agency (EPA) for public drinking water.

DATES: This rule is effective April 16, 2012. The incorporation by 
reference of certain publications listed in the rule is approved by the 
Director of the Federal Register as of April 16, 2012.

FOR FURTHER INFORMATION CONTACT: Lauren Posnick Robin, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-1639. Hearing-
impaired or speech-impaired individuals may access this number through 
TTY by calling the toll-free Federal Relay Service at 800-877-8339.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 4, 1993 (58 FR 41612), FDA 
published a proposal (``the 1993 proposed rule'') to revise the bottled 
water quality standard regulations in 21 CFR part 103 (now 21 CFR 
165.110(b)) to establish or modify the allowable levels in bottled 
water for 5 inorganic chemicals and 18 synthetic organic chemicals, and 
to maintain the existing allowable level for the inorganic chemical 
sulfate. As required under Section 410 of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act), FDA proposed these revisions in response to 
the publication by EPA of a final rule (57 FR 31776; July 17, 1992) 
that established national primary drinking water regulations (NPDWRs) 
consisting of maximum contaminant levels (MCLs) for the same 23 
chemicals and establishing an MCL for sulfate in public drinking water 
under the Safe Drinking Water Act (SDWA). In a final rule published 
March 26, 1996 (61 FR 13258), FDA maintained its existing allowable 
level for sulfate and adopted the proposed allowable levels for the 5 
inorganic chemicals and 17 of the synthetic organic chemicals. FDA 
deferred final action on the proposed allowable level of 0.006 
milligrams/liter (mg/L) for the chemical DEHP, in response to a comment 
stating that the proposed allowable level conflicted with an existing 
prior sanction for this substance in Sec.  181.27 (21 CFR 181.27).
    In the Federal Register of April 1, 2010 (75 FR 16363), FDA 
announced that it was reopening the comment period for the 1993 
proposed rule to seek further comment on finalizing the allowable level 
for DEHP in the bottled water quality standard. At the same time, FDA 
addressed the issue of the prior sanction for the use of DEHP under 
Sec.  181.27, which resulted in deferral of final action in 1996. FDA 
also provided updates on the use of DEHP in bottled water bottles and 
lid gaskets, and on international standards for DEHP in bottled water. 
Finally, FDA provided information on analytical methods for measuring 
DEHP that were adopted by EPA after the 1993 proposed rule and sought 
comment on the possible inclusion of these methods in a final 
regulation.

II. Summary of and Response to Comments

    The agency received 10 responses, each containing one or more 
comments, to the April 1, 2010, Federal Register document reopening the 
comment period for the 1993 proposed rule. The agency previously 
received 13 responses, each containing one or more comments, to the 
1993 proposed rule. Some comments addressed issues that are outside the 
scope of this final rule (e.g., monitoring requirements, other 
chemicals, and food labeling), and thus will not be discussed here.
    Most comments supported adoption of an allowable level for DEHP. As 
noted previously, one comment received in response to the 1993 proposed 
rule stated that the proposed allowable level for DEHP conflicted with 
an existing prior sanction for this substance in Sec.  181.27. This 
comment also stated that DEHP is routinely used as a plasticizer in 
gaskets, and that such gaskets are permitted for use under relevant 
European national regulations. FDA responded to this comment in the 
April 1, 2010, Federal Register document. Briefly, FDA stated that the 
prior sanction for the use of DEHP in Sec.  181.27 does not preclude 
the agency from establishing an allowable level for DEHP in the bottled 
water quality standard under Sec.  165.110(b). FDA also stated that it 
appears that DEHP currently is not used in caps or closures for bottled 
water in the United States (Ref. 1), and that DEHP use is not permitted 
under European Commission regulations for plastic caps or plastic lid 
gaskets in metal caps (Ref. 2). Finally, FDA stated that several 
international organizations have adopted standards for DEHP that are 
the same or similar to the proposed allowable level of 0.006 mg/L, and 
that the International Bottled Water Association (IBWA), a trade 
association representing a large segment of the U.S. bottled water 
industry, adopted EPA's 0.006 mg/L standard for DEHP (40 CFR 141.61(c)) 
in its Model Code by 1995, suggesting that U.S. manufacturers already 
are able to meet the proposed level (Refs. 3 and 4). FDA did not 
receive any comments disagreeing with FDA's conclusions.
    Two comments received in response to the April 1, 2010, Federal 
Register document opposed action related to DEHP in bottled water. The 
first

[[Page 64811]]

comment stated that there was no reason to change current standards for 
plastic water bottles because evidence from two studies puts previous 
concerns to rest concerning the effects of DEHP consumption in humans. 
In response, FDA notes that it is establishing an allowable level for 
DEHP in bottled water, not changing standards for plastic bottles. 
Furthermore, FDA does not agree that the comment provided sufficient 
evidence to challenge EPA's finding that long-term, chronic exposure to 
DEHP above the MCL of 0.006 mg/L may have the potential to cause health 
effects in humans including damage to liver and testes, reproductive 
effects, and cancer (Ref. 5). Therefore, FDA continues to believe that 
it is appropriate to base its allowable level for DEHP in bottled water 
upon the MCL established by EPA for public drinking water.
    A second comment received in response to the April 1, 2010, Federal 
Register document stated that DEHP does not leach into water in 
appreciable amounts and that prohibiting the use of DEHP would increase 
costs for consumers for beverages packaged in plastic bottles. However, 
this rule does not prohibit the use of DEHP; rather, it sets an 
allowable level for DEHP in bottled water. The allowable level for DEHP 
in bottled water is intended to address the potential presence of DEHP 
in water for any reason, not just leaching from bottles or caps. 
Furthermore, the comment did not provide any evidence to support or 
quantify its statement that DEHP does not leach into water in 
appreciable amounts. Finally, FDA disagrees that the regulation would 
increase costs for consumers. Many U.S. manufacturers already appear to 
be meeting the allowable level for DEHP in bottled water (Refs. 3 and 
4). In fact, information from industry suggests that DEHP currently is 
not used in bottled water caps or bottles in the United States (Refs. 1 
and 6). Therefore, FDA does not agree with the comment's assertion that 
the rule prohibits the use of DEHP or its assertion that the rule would 
increase costs for consumers for beverages packaged in plastic bottles.
    In the April 1, 2010, Federal Register document, FDA noted that EPA 
had updated its methods for DEHP analysis after FDA published the 1993 
proposal. FDA made available the updated methods (Refs. 7 and 8) for 
comment on their possible inclusion in the final regulation. FDA did 
not receive any comments disagreeing with adoption of the updated 
methods.

III. Conclusion

    The agency is adopting the allowable level for DEHP in the bottled 
water quality standard as proposed (58 FR 41612). Therefore, FDA is 
establishing in Sec.  165.110(b)(4)(iii)(C) (21 CFR 
165.110(b)(4)(iii)(C)), which includes allowable levels for pesticides 
and other synthetic organic chemicals, an allowable level for DEHP at 
0.006 mg/L.
    As a consequence, in accordance with FDA's current good 
manufacturing practice (CGMP) regulations for bottled water (21 CFR 
part 129), bottled water manufacturers will be required to monitor 
their source water and finished bottled water products for DEHP. 
Bottled water manufacturers will be required to monitor their source 
water for DEHP as often as necessary, but at a minimum frequency of 
once each year (21 CFR 129.35(a)(3)), unless they meet the criteria for 
source water monitoring exemptions under the CGMP regulations (21 CFR 
129.35(a)(4)). Bottled water manufacturers will be required to monitor 
their finished products for DEHP at least once a year (21 CFR 
129.80(g)(2)).
    With respect to analytical methods for the determination of 
chemical contaminants, FDA is making the following changes in Sec.  
165.110(b)(4)(iii). In the revised Sec.  165.110(b)(4)(iii)(F) 
introductory text and in new Sec.  165.110(b)(4)(iii)(F)(21) and 
(b)(4)(iii)(F)(22), FDA is incorporating by reference EPA-approved 
analytical methods for determining compliance with the quality standard 
for DEHP in bottled water. FDA believes that these methods are 
sufficient to use for determining the level of DEHP in bottled water. 
These methods are contained in the manual entitled ``Methods for the 
Determination of Organic Compounds in Drinking Water, Supplement III,'' 
EPA National Exposure Research Laboratory, EPA/600/R-95/131, August 
1995.
    Therefore, upon the effective date of this rule, any bottled water 
that contains DEHP at a level that exceeds the applicable allowable 
level will be deemed misbranded under section 403(h)(1) of the FD&C 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. 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. Executive Order 12866: Cost Benefit Analysis

    FDA has examined the impacts of this final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct 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). Executive Order 13563 emphasizes the importance of quantifying 
both costs and benefits, of reducing costs, of harmonizing rules, and 
of promoting flexibility. The agency concludes that this final rule is 
not a significant regulatory action as defined by Executive Order 
12866.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the costs per entity of this rule are small, 
the agency also concludes that this final rule will not have a 
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4) requires that agencies prepare a written statement, which 
includes an assessment of anticipated costs and benefits, before 
proposing ``any rule that includes any Federal mandate that may result 
in the expenditure by State, local, and tribal governments, in the 
aggregate, or by the private sector, of $100,000,000 or more (adjusted 
annually for inflation) in any one year.'' The current threshold after 
adjustment for inflation is $136 million, using the most current (2010) 
Implicit Price Deflator for the Gross Domestic Product. FDA does not 
expect this final rule to result in any 1-year expenditure that would 
meet or exceed this amount.
    The Economic Impact Analysis of the 1996 final rule (61 FR 13258) 
revised the analysis set forth in the 1993 proposed rule (58 FR 41612) 
in response to comments received. Likewise, this final Economic Impact 
Analysis revises the analysis set forth in the 1993 proposed rule in 
response to comments received.

[[Page 64812]]

A. Need for Regulation

    Section 410 of the FD&C Act (21 U.S.C. 349) \1\ requires that, 
whenever EPA prescribes interim or revised NPDWRs under section 1412 of 
the Public Health Service Act (The SDWA, 42 U.S.C. 300f through 300j-
9), FDA 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 
accordance with section 410 of the FD&C Act, FDA published in the 
Federal Register of August 4, 1993 (58 FR 41612), a proposal to adopt 
EPA's MCL for DEHP as an allowable level in the bottled water quality 
standard. This action was in response to EPA's issuance of an NPDWR 
establishing an MCL for DEHP in public drinking water on July 17, 1992 
(57 FR 31776). As described above, FDA deferred final action on the 
proposed allowable level for DEHP on March 26, 1996 (61 FR 13258). By 
finalizing the allowable level for DEHP in the bottled water quality 
standard, FDA is meeting the requirement in the FD&C Act to amend its 
regulations for bottled drinking water in response to EPA's 
establishment of an MCL for DEHP.
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    \1\ Section 410 of the FD&C Act was amended on August 6, 1996 to 
add subsection (b), related to contaminants for which EPA has 
promulgated NPDWRs under section 1412 of the SDWA. Specifically, 
this provision provides that, if FDA fails to issue a standard of 
quality regulation for a contaminant in bottled water not later than 
180 days before the effective date of a NPDWR for that contaminant, 
EPA's NPDWR will apply to bottled water. FDA has interpreted this 
provision as not applying retroactively to EPA's NPDWR for DEHP.
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    Although DEHP is not expected to be found in bottled water in 
levels above the standard, FDA concludes that this rule is protective 
of public health because it will ensure that, should current conditions 
change, such as new sources of water or new manufacturing practices, 
the level of DEHP will remain low.

B. Costs

    In the 1993 proposed rule, FDA stated that a single test can be 
used to analyze 23 contaminants, including DEHP, with costs of up to 
$3,000 per sample. Comments submitted by IBWA in response to the 1993 
proposed rule stated that a single test can be used for 14 
contaminants, including DEHP and certain previously regulated 
contaminants, and that no additional testing costs would be required 
(Ref. 9). Although FDA is adopting new methods for DEHP analysis in 
this final rule (EPA Method 506, Rev. 1-1, and EPA Method 525.2, Rev. 
2.0), EPA Method 525.2 tests for multiple currently regulated 
chemicals, including all the chemicals that were detected by the 
previously proposed method, EPA Method 525.1, Rev. 2.2. Since no 
additional testing is needed for DEHP, and since the costs of testing 
for DEHP have already been estimated in the 1993 proposed rule, FDA 
expects no additional testing costs resulting from the adoption of an 
allowable level for DEHP.
    As discussed above, many U.S. manufacturers already appear to be 
meeting the allowable level (Refs. 3 and 4). Further, information from 
industry suggests that DEHP currently is not used in bottled water caps 
or bottles in the United States (Refs. 1 and 6). Thus, no reformulation 
costs are expected because DEHP is not expected to be found in bottled 
water in levels above the standard.

C. Benefits

    In the Economic Impact Analysis of the 1993 proposed rule, FDA 
determined that, because none of the 23 contaminants including DEHP are 
expected to be found in bottled water above the levels of the 
standards, the benefits of the proposed rule were expected to be zero. 
Because the 23 contaminants, including DEHP, still are not expected to 
be found in bottled water at levels above the standards, benefits of 
this final rule continue to be zero. However, as stated in the Economic 
Impact Analysis in the 1996 final rule for the other contaminants (61 
FR 13258), this rule continues to ensure that, should current 
conditions change, such as new sources of water or new manufacturing 
practices, the level of DEHP and other contaminants will remain low.

VI. Small Entity Analysis

    FDA examined the economic implications of this final rule as 
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a 
rule has a significant economic impact on a substantial number of small 
entities, the Regulatory Flexibility Act requires us to analyze 
regulatory options that would lessen the economic effect of the rule on 
small entities.
    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 1996 Economic Impact Analysis found 
that the final rule will not have a significant impact on a substantial 
number of small businesses.
    As stated in the analysis of impacts, information from industry 
suggests that DEHP currently is not used in bottled water caps or 
bottles in the United States (Refs. 1 and 6). Furthermore, many U.S. 
manufacturers already appear to be meeting the allowable level (Refs. 3 
and 4). Thus, no reformulation costs are expected because DEHP is not 
expected to be found in bottled water above the levels of the standard.
    For the reasons stated above, we do not classify as costs of this 
final rule any voluntary expenses that some small firms may incur 
because they already chose to meet the new standards for DEHP set forth 
in this rule.

VII. Paperwork Reduction Act of 1995

    FDA concludes that the provisions of this final rule are not 
subject to review by the Office of Management and Budget because they 
do not constitute a ``collection of information'' under the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3220).

VIII. Federalism

    FDA has analyzed this rule in accordance with the principles set 
forth in Executive Order 13132. Section 4(a) of the Executive Order 
requires agencies to ``construe * * * a Federal statute to preempt 
State law only where the statute contains an express preemption 
provision or there is some other clear evidence that the Congress 
intended preemption of State law, or where the exercise of State 
authority conflicts with the exercise of Federal authority under the 
Federal statute.''
    Section 403A of the FD&C Act (21 U.S.C. 343-1) is an express 
preemption provision. Section 403A(a) of the FD&C Act provides that: 
``* * * no State or political subdivision of a State may directly or 
indirectly establish under any authority or continue in effect as to 
any food in interstate commerce--(1) Any requirement for a food which 
is the subject of a standard of identity established under section 401 
that is not identical to such standard of identity or that is not 
identical to the requirement of section 403(g) * * *.'' FDA has 
interpreted this provision to apply to standards of quality (21 CFR 
100.1(c)(4)).
    The express preemption provision of section 403A(a) of the FD&C Act 
does not preempt any State or local requirement respecting a statement 
in the labeling of food that provides for a warning concerning the 
safety of the food or component of the food (section 6(c)(2) of the 
Nutrition Labeling and Education Act of 1990, Pub. L. 101-535, 104 
Stat. 2353, 2364 (1990)).
    This final rule creates requirements that fall within the scope of 
section 403A(a) of the FD&C Act.

[[Page 64813]]

IX. References

    The following references have been placed on display in the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852 and may be seen by interested persons between 9 a.m. and 4 
p.m., Monday through Friday. (FDA has verified the Web site addresses, 
but FDA is not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)

1. Memorandum of telephone conversation to John Rost, Crown 
Packaging Technology, from Lauren Robin, FDA, January 5, 2010.
2. European Commission, 2007, Commission Directive 2007/19/EC of 30 
March 2007 amending Directive 2002/72/EC relating to plastic 
materials and articles intended to come into contact with food and 
Council Directive 85/572/EEC laying down the list of simulants to be 
used for testing migration of constituents of plastic materials and 
articles intended to come into contact with foodstuffs, Official 
Journal of the European Union, 31.3.2007, L 91/17-36.
3. IBWA, 2007, IBWA Model Code, Version October 2007, accessed 
online at https://www.bottledwater.org/public/pdf/2008-code-of-practice.pdf.
4. E-mail from Bob Hirst, IBWA, to Lauren Robin, FDA, January 5, 
2010.
5. U.S. EPA, Technical factsheet on di (2-ethylhexyl) phthalate 
(DEHP), accessed online at https://www.epa.gov/safewater/pdfs/factsheets/soc/tech/dehp.pdf.
6. Joseph K. Doss, IBWA, Testimony before the Subcommittee on 
Oversight and Investigations of the Energy and Commerce Committee, 
United States House of Representatives, Hearing on Bottled Water 
Regulation, July 8, 2009, accessed online at https://democrats.energycommerce.house.gov/Press_111/20090708/testimony_doss.pdf.
7. U.S. EPA, EPA Method 506, Rev. 1.1--``Determination of phthalate 
and adipate esters in drinking water by liquid/liquid extraction or 
liquid/solid extraction and gas chromatography with photoionization 
detection,'' in ``Methods for the Determination of Organic Compounds 
in Drinking Water, Supplement III,'' EPA National Exposure Research 
Laboratory, EPA/600/R-95/131, August 1995, accessed online at https://www.epa.gov/nscep/.
8. U.S. EPA, EPA Method 525.2, Rev. 2.0--``Determination of organic 
compounds in drinking water by liquid-solid extraction and capillary 
column gas chromatography/mass spectrometry,'' In ``Methods for the 
Determination of Organic Compounds in Drinking Water, Supplement 
III,'' EPA National Exposure Research Laboratory, EPA/600/R-95/131, 
August 1995, accessed online at https://www.epa.gov/nscep/.
9. International Bottled Water Association, comment to FDA Docket 
Number 1993N-0085, October 4, 1993.

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

0
1. The authority citation for 21 CFR part 165 continues to read as 
follows:

    Authority:  21 U.S.C. 321, 341, 343, 343-1, 348, 349, 371, 379e.

0
2. In Sec.  165.110, in the table in paragraph (b)(4)(iii)(C), 
alphabetically add an entry for ``Di(2-ethylhexyl)phthalate (117-81-
7)''; revise paragraph (b)(4)(iii)(F) introductory text; and add new 
paragraphs (b)(4)(iii)(F)(21) and (b)(4)(iii)(F)(22) to read as 
follows:


Sec.  165.110  Bottled water.

* * * * *
    (b) * * *
    (4) * * *
    (iii) * * *
    (C) The allowable levels for pesticides and other synthetic organic 
chemicals (SOCs) are as follows:

------------------------------------------------------------------------
                                                          Concentration
               Contaminant (CAS Reg. No.)                 in milligrams
                                                            per liter
------------------------------------------------------------------------
 
                                * * * * *
Di(2-ethylhexyl)phthalate (117-81-7)...................            0.006
 
                                * * * * *
------------------------------------------------------------------------

* * * * *
    (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)(22) 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, or in ``Methods for the 
Determination of Organic Compounds in Drinking Water, Supplement III,'' 
EPA National Exposure Research Laboratory, Office of Research and 
Development, EPA/600/R-95/131, August 1995, including Errata, November 
27, 1995. The Director of the Federal Register approves this 
incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR 
part 51. Copies of these publications are available from National 
Technical Information Service, U.S. Department of Commerce, 5285 Port 
Royal Rd., Springfield, VA 22161. You may inspect a copy at the 
Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, 
MD 20852, 301-827-6860 or at the National Archives and Records 
Administration (NARA). Hearing-impaired or speech-impaired individuals 
may access this number through TTY by calling the toll-free Federal 
Relay Service at 800-877-8339. For information on the availability of 
this material at NARA, call 202-741-6030, or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.
* * * * *
    (21) Method 506, Rev. 1.1--``Determination of phthalate and adipate 
esters in drinking water by liquid/liquid extraction or liquid/solid 
extraction and gas chromatography with photoionization detection,'' 
EPA/600/R-95/131, 1995, (applicable to di(2-ethylhexyl)phthalate), 
which is incorporated by reference in accordance with 5 U.S.C. 552(a) 
and 1 CFR part 51, or
    (22) Method 525.2, Rev. 2.0--``Determination of organic compounds 
in drinking water by liquid-solid extraction and capillary column gas 
chromatography/mass spectrometry,'' EPA/600/R-95/131, 1995, (applicable 
to di(2-ethylhexyl)phthalate), which is incorporated by reference in 
accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
* * * * *

    Dated: October 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-26707 Filed 10-18-11; 8:45 am]
BILLING CODE 4160-01-P