[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