[Federal Register Volume 75, Number 62 (Thursday, April 1, 2010)]
[Proposed Rules]
[Pages 16363-16365]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-7292]


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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; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until June 
1, 2010 the comment period for the proposed rule, published in the 
Federal Register of August 4, 1993 (58 FR 41612), amending the quality 
standard for bottled water (currently in 21 CFR 165.110(b)). In the 
1993 proposed rule, FDA proposed to revise the bottled water quality 
standard to establish or modify the allowable levels for 5 inorganic 
chemicals and 18 synthetic organic chemicals, and to maintain the 
existing allowable level for the inorganic chemical sulfate. In a final 
rule published March 26, 1996 (61 FR 13258), FDA maintained the 
existing allowable level for sulfate and adopted the proposed allowable 
levels for the 5 inorganic chemicals and 17 of the synthetic organic 
chemicals, but deferred final action on the proposed allowable level 
for the chemical di(2-ethylhexyl)phthalate (DEHP). FDA is reopening the 
comment period on the 1993 proposed rule to seek further comment on 
finalizing the allowable level for DEHP in the bottled water quality 
standard.

DATES: Submit written or electronic comments by June 1, 2010.

[[Page 16364]]


ADDRESSES: You may submit comments, identified by Docket No. FDA 1993-
N-0259, by any of the following methods.
Electronic Submissions
Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
     FAX: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and docket number for this rulemaking. All comments received may be 
posted without change to http://www.regulations.gov, including any 
personal information provided. For additional information on submitting 
comments, see the ``Comments'' heading in the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, found in brackets in the heading of this document, into 
the ``Search'' box and follow the prompts and/or go to the Division of 
Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
rm.1061, Rockville, MD 20852.

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, 301-436-1639.

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 standard of quality 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. FDA proposed these revisions in response to the publication by 
the Environmental Protection Agency (EPA) of a final rule (57 FR 31776; 
July 17, 1992) that established national primary drinking water 
regulations consisting of maximum contaminant levels (MCLs) for the 
same 23 chemicals and establishing an MCL for sulfate in public 
drinking water. 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, but deferred final action on the proposed 
allowable level of 0.006 milligrams/liter (mg/L) for the chemical di(2-
ethylhexyl)phthalate (DEHP). FDA deferred action on 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). The comment stated that DEHP is prior sanctioned in Sec.  
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 
stated 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 stated that gaskets containing 
DEHP are permitted for use in packaging food and bottled water under 
relevant European national regulations.
    In the 1996 final rule, FDA stated that it 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. FDA also stated that the agency needed 
additional time to evaluate this matter and to determine an appropriate 
course of action with respect to the proposed allowable level for DEHP 
and, therefore, FDA was deferring final action on the proposed 
allowable level for DEHP at that time.

II. Request for Comments

    FDA is now considering finalizing the allowable level of 0.006 mg/L 
for DEHP in the quality standard for bottled water in Sec.  165.110(b). 
Because of the length of time that has elapsed since the 1993 proposed 
rule, FDA is seeking additional comments on establishing an allowable 
level for DEHP. Comments previously submitted to the Division of 
Dockets Management on the issue of establishing an allowable level for 
DEHP do not need to be and should not be resubmitted. All comments on 
DEHP previously submitted to the docket number found in brackets in the 
heading of this document, and comments on DEHP submitted in response to 
this reopening of the comment period, will be considered in any final 
rule finalizing the allowable level for DEHP in the quality standard 
for bottled water.
    In this document, FDA is addressing 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 is also providing updates on the use of DEHP 
in bottled water bottles and lid gaskets, and on international 
standards for DEHP in bottled water. Finally, FDA is providing 
information on analytical methods for measuring DEHP that were adopted 
by EPA after the 1993 proposed rule, and is seeking comment on the 
possible inclusion of these methods in the final regulation.
    A. Prior Sanction for Use of DEHP
    FDA has determined that the prior sanction for the use of DEHP in 
Sec.  181.27, which exempts the use listed in Sec.  181.27 from the 
food additive provisions of the Federal Food, Drug, and Cosmetic Act 
(the act), does not preclude the agency from establishing an allowable 
level for DEHP in the standard of quality for bottled water under Sec.  
165.110(b). The existence of a prior sanction exempts ``sanctioned uses 
from the food additive provisions of the [a]ct but not from the other 
adulteration or the misbranding provisions of the [a]ct.'' 21 CFR 
181.5(b). Therefore, while a food product containing DEHP consistent 
with its prior sanction could not be considered adulterated within the 
meaning of section 402(C)(i) of the act, it could be considered 
adulterated or misbranded under other adulteration or the misbranding 
provisions of the act.
    Under section 403(h)(1) of the act (21 U.S.C. 343(h)(1)), bottled 
water that is of a quality below the prescribed standard in Sec.  
165.110(b) is required by Sec.  165.110(c) to be labeled with a 
statement of substandard quality or it is deemed misbranded. Thus, if 
an allowable level for DEHP is finalized under the quality standard for 
bottled water, finished bottled water products with DEHP levels above 
the finalized level will be misbranded if the products do not bear 
label statements of substandard quality. FDA also notes that under the 
adulteration provisions of the

[[Page 16365]]

act, bottled water containing DEHP at a level considered injurious to 
health under section 402(a)(1) of the act is deemed to be adulterated.
    B. Use of DEHP in Bottled Water Bottles and Lid Gaskets
    The comment on the 1993 proposal stated that: (a) DEHP is routinely 
used as a plasticizer in gaskets used in metal and plastic closures for 
the packaging of bottled water in accord with the prior sanction, and 
that such use may result in levels of DEHP migrating into water that 
exceed the proposed allowable level, and that (b) gaskets containing 
DEHP are permitted for use in packaging food and bottled water under 
relevant European national regulations. However, based on information 
from industry, it appears that DEHP currently is not used in caps or 
closures for bottled water in the U.S (Ref. 1). Furthermore, FDA notes 
that current European Commission (EC) regulations limit the use of DEHP 
as a plasticizer in food contact materials to repeated use materials 
(Ref. 2). DEHP use is not permitted under EC regulations for plastic 
caps or plastic lid gaskets in metal caps.
    C. International Standards for DEHP in Bottled Water
    FDA also notes that several international organizations have 
adopted standards for DEHP that are the same or similar to FDA's 
proposed allowable level of 0.006 mg/L. The International Bottled Water 
Association (IBWA), a trade association representing a large segment of 
the U.S. bottled water industry, had adopted EPA's 0.006 mg/l standard 
for DEHP in its Model Code by 1995, suggesting that U.S. manufacturers 
already are able to meet the proposed level (Refs. 3 and 4). In 
addition, the World Health Organization (WHO) has established a 
guideline value for DEHP in drinking water of 0.008 mg/L (Ref. 5). The 
Codex Alimentarius General Standard for Bottled/Packaged Drinking 
Waters (Other than Natural Mineral Waters) requires that bottled/
packaged drinking waters comply with WHO's guideline values (Ref. 6).
    D. Analytical Methodology
    In the 1993 proposal, FDA proposed adopting EPA Method 506 (Ref. 7) 
and EPA Method 525.1, Revision 3.0, (Ref. 8) for analysis of selected 
chemicals, including DEHP (58 FR 41612). In the 1996 document, FDA 
adopted EPA Methods 506 and 525.1, Rev. 3.0, for all the chemicals with 
the exception of DEHP (61 FR 13258). EPA has since updated its methods 
for DEHP (Refs. 9 and 10). In this document, FDA is making EPA's 
updated methods for DEHP analysis (Refs. 9 and 10) available for 
comment on their possible inclusion in the final regulation.

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. Received comments may be seen in the 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

IV. References

    FDA has placed the following references on display in FDA's 
Division of Dockets Management (see ADDRESSES). You may see them 
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 Web sites after this document publishes in the Federal 
Register.)
    1. John Rost, Crown Packaging Technology, 2010, personal 
communication, 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. International Bottled Water Association, 2007, IBWA Model 
Code, Version October 2007, accessed online at http://www.bottledwater.org/files/IBWA%20Bottled%20Water%20Code%20of%20Practice.pdf.
    4. International Bottled Water Association, 2007, personal 
communication, August 30, 2007.
    5. World Health Organization, 2008, Guidelines for drinking-
water quality, third edition, incorporating first and second 
addenda, World Health Organization: Geneva, accessed online at 
http://www.who.int/water_sanitation_health/dwq/fulltext.pdf.
     6. Codex Alimentarius, 2001, General Standard for Bottled/
Packaged Drinking Waters (Other than Natural Mineral Waters), CODEX 
STAN 227-2001, accessed online at www.codexalimentarius.net/download/standards/369/CXS_227e.pdf.
    7. U.S. Environmental Protection Agency (EPA), EPA 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, '' In ``Methods for 
the Determination of Organic Compounds in Drinking Water, Supplement 
I,'' July 1990.
    8. U.S. EPA, EPA Method 525.1, Revision 2.2--``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 I,'' May 1991, accessed online at http://www.epa.gov/waterscience/methods/method/files/525_1.pdf
    9. 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 ``Analytical Methods Approved for 
Drinking Water Compliance Monitoring of Organic Contaminants,'' June 
2008, accessed online at http://www.epa.gov/ogwdw000/methods/pdfs/methods/organic_080521b.pdf.
    10. 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 
``Analytical Methods Approved for Drinking Water Compliance 
Monitoring of Organic Contaminants,'' June 2008, accessed online at 
http://www.epa.gov/ogwdw000/methods/pdfs/methods/organic_080521b.pdf.

    Dated: March 24, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-7292 Filed 3-31-10; 8:45 am]
BILLING CODE 4160-01-S