![[logo] US EPA](http://www.epa.gov/epafiles/images/logo_epaseal.gif){kind=logo}
Pesticides; Tolerance Exemptions for Active and Inert Ingredients for Use in Antimicrobial Formulations (Food-Contact Surface Sanitizing Solutions)
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: June 25, 2003 (Volume 68, Number 122)]
[Proposed Rules]
[Page 37778-37792]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25jn03-23]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-2003-0121; FRL-7302-2]
Pesticides; Tolerance Exemptions for Active and Inert Ingredients
for Use in Antimicrobial Formulations (Food-Contact Surface Sanitizing
Solutions)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing to add a new section to part 180 which lists
the pesticide chemicals that are exempt from the requirement of a
tolerance when used in food-contact surface sanitizing solutions. The
initial list of exempt pesticide chemicals in the new section is
duplicated from the Food and Drug Administration's (FDA) regulations in
21 CFR 178.1010. EPA is also changing FDA's naming conventions for some
of the chemical substances that were duplicated.
Until recently, FDA under the Federal Food, Drug, and Cosmetic Act
(FFDCA) section 409, regulated food-contact surface sanitizing
solutions. With the amendments to FFDCA by the Food Quality Protection
Act (FQPA) of 1996 and by the Antimicrobial Regulation Technical
Corrections Act (ARTCA) of 1998, these responsibilities have been
restructured. Under FFDCA section 408, EPA will now regulate the
pesticide uses of these chemical substances and FDA under FFDCA section
409 will continue to regulate any indirect food additive uses of these
chemical substances.
Registrants of existing food-contact surface sanitizing solutions
that contain chemical substances other than those listed in this
proposed rule should identify these chemical substances and support
their claim that the chemical substance is generally recognized as safe
(GRAS), or permitted by FDA prior sanction, or approval, or subject to
a letter of no objection in order to remain exempt from the requirement
of a FFDCA section 408 tolerance.
DATES: Comments, identified by docket ID number OPP-2003-0121, must be
received on or before July 25, 2003.
Registrants should identify chemical substances not listed in this
document and support their claims of GRAS, or prior sanction, or
approval, or no objection of these chemical substances by submission of
such information to the person listed under FOR FURTHER INFORMATION, on
or before October 1, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
Registrants identifying chemical substances not listed in this
document and the supporting documentation for their claims of GRAS, or
prior sanction, or approval, or no objection of these chemical
substances for inclusion in 40 CFR 180.940 should submit the
information directly to the person listed under FOR FURTHER
INFORMATION.
[[Page 37779]]
Identification of a chemical substance is not a comment and should be
identified as ``Submission of Non-designated Prior Approved
Substance.''
FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6304; fax number: (703) 305-0599; e-mail address:
boyle.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you formulate or
market pesticide products. Potentially affected categories and entities
may include, but are not limited to:
? Food manufacturing (NAICS 311)
? Antimicrobial pesticides (NAICS 32561)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Get Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket identification (ID) number OPP-2003-0121. The
official public docket consists of the documents specifically
referenced in this action, any public comments received, and other
information related to this action. Although a part of the official
docket, the public docket does not include Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute. The official public docket is the collection of materials
that is available for public viewing at the Public Information and
Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall #2,
1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The docket telephone number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/. A frequently updated
electronic version of 40 CFR part 180 is available at http://www.access.
gpo.gov/nara/cfr/cfrhtml_00/Title_40/40cfr180_00.html, 
a beta site currently under development.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.regulations.gov/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Once in the system, select ``search,''
then key in the appropriate docket ID number.
Certain types of information will not be placed in the EPA Dockets.
Information claimed as CBI and other information whose disclosure is
restricted by statute, which is not included in the official public
docket, will not be available for public viewing in EPA's electronic
public docket. EPA's policy is that copyrighted material will not be
placed in EPA's electronic public docket but will be available only in
printed, paper form in the official public docket. To the extent
feasible, publicly available docket materials will be made available in
EPA's electronic public docket. When a document is selected from the
index list in EPA Dockets, the system will identify whether the
document is available for viewing in EPA's electronic public docket.
Although not all docket materials may be available electronically, you
may still access any of the publicly available docket materials through
the docket facility identified in Unit I.B.1. EPA intends to work
towards providing electronic access to all of the publicly available
docket materials through EPA's electronic public docket.
For public commenters, it is important to note that EPA's policy is
that public comments, whether submitted electronically or in paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA Dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also include this contact information on the
outside of any disk or CD ROM you submit, and in any cover letter
accompanying the disk or CD ROM. This ensures that you can be
identified as the submitter of the comment and allows EPA to contact
you in case EPA cannot read your comment due to technical difficulties
or needs further information on the substance of your comment. EPA's
policy is that EPA will not edit your comment, and any identifying or
contact information provided in the body of a comment will be included
as part of the comment that is placed in the official public docket,
and made available in EPA's electronic public docket. If EPA cannot
read your comment due to technical difficulties and cannot contact you
for clarification, EPA may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA Dockets at http://www.epa.gov/
edocket, and
[[Page 37780]]
follow the online instructions for submitting comments. Once in the
system, select ``search,'' and then key in docket ID number OPP-2003-
0121. The system is an ``anonymous access'' system, which means EPA
will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to: opp-docket@epa.gov,
Attention: Docket ID Number OPP-2003-0121. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID Number OPP-2003-0121.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
#2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID Number OPP-2003-0121. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI To the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is CBI). Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
In addition to one complete version of the comment that includes
any information claimed as CBI, a copy of the comment that does not
contain the information claimed as CBI must be submitted for inclusion
in the public docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed under FOR FURTHER INFORMATION CONTACT.
E. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your
comments:
1. Explain your views as clearly as possible.
2. Describe any assumptions that you used.
3. Provide any technical information and/or data you used that
support your views.
4. If you estimate potential burden or costs, explain how you
arrived at your estimate.
5. Provide specific examples to illustrate your concerns.
6. Offer alternatives.
7. Make sure to submit your comments by the comment period deadline
identified.
8. To ensure proper receipt by EPA, identify the appropriate docket
ID number in the subject line on the first page of your response. It
would also be helpful if you provided the name, date, and Federal
Register citation related to your comments.
II. What is the Agency's Authority for Taking this Action?
This proposed rule is issued under FFDCA section 408, 21 U.S.C.
346a, as amended by FQPA (Public Law 104-170), and ARTCA (Public Law
105-324).
Section 408 of FFDCA authorizes the establishment of tolerances,
exemptions from the requirement of a tolerance, modifications in
tolerances, and revocation of tolerances for residues of pesticide
chemicals in or on raw agricultural commodities and processed foods.
Section 408(j)(2) of FFDCA provides that all regulations issued by FDA
under FFDCA section 409 that stated conditions for safe use of
substances that are now, post-FQPA, considered pesticide chemical
residues in or on processed food or that otherwise stated the
conditions under which such pesticide chemicals could be safely used,
shall be deemed to be regulations issued under FFDCA section 408.
Due to the FQPA and ARTCA amendments to FFDCA, those chemical
substances originally regulated by FDA under FFDCA section 409 as food-
contact surface sanitizing solutions are now the responsibility of EPA.
These pesticide chemical regulations are now subject to modification or
revocation at EPA's initiative under FFDCA section 408(e). The Agency
is proposing to duplicate the substance of FDA's food additive
regulations for those chemical substances found in 21 CFR 178.1010
which are now pesticide tolerance exemptions in a format consistent
with EPA's authority under section 408 in a new section, 40 CFR
180.940.
EPA's rulemaking activity will have no effect on any of the FDA
regulated FFDCA section 409 food additive regulations in 21 CFR
178.1010.
III. Summary of this Action
A. Why is There an Overlap of EPA's and FDA's Regulatory Authorities?
Since EPA was created in 1970, EPA and FDA have shared authority
under FFDCA over pesticide chemical residues in food. Enactment of FQPA
in 1996 amended FFDCA, and shifted to EPA regulatory authority over
certain pesticide residues which were previously subject to FDA
authority. Prior to 1996, products used to sanitize or disinfect
permanent or semi-permanent food-contact surfaces were regulated by FDA
as indirect food additives under FFDCA section 409. Under the FQPA and
ARTCA amendments to FFDCA, antimicrobial formulations used on permanent
or semi-permanent food-contact surfaces other than food packaging are
now considered ``pesticide chemicals'' and are regulated by EPA under
FFDCA section 408.
FQPA added a provision to FFDCA to assure an orderly transition to
the new regulatory system. Section 408(j)(2) of FFDCA provides that all
food additive regulations issued under FFDCA section 409 prior to the
enactment of FQPA for antimicrobial uses that became pesticide chemical
uses subsequent to FQPA and that were not affected by ARTCA shall be
deemed to be regulations issued under FFDCA section 408. Thus, FQPA
converted existing food additive regulations issued by FDA under FFDCA
section 409, for chemical substances that post-FQPA became pesticide
chemicals, into FFDCA section
[[Page 37781]]
408 pesticide chemical tolerances or tolerance exemptions. This
``grandfather'' provision of FFDCA section 408(j) assures that
pesticide chemical residues conforming to regulations issued under the
authority of FFDCA section 409 will not render food adulterated as a
result of the jurisdictional shift from FDA to EPA.
In 1998, ARTCA amended the definition of ``pesticide chemical'' in
FFDCA section 201(q) so as to exclude certain antimicrobial pesticide
residues from the authority of FFDCA section 408. Consistent with FFDCA
section 408(j)(4), these residues now fall within the authority of
FFDCA section 409. As a result, certain uses of food-contact surface
sanitizing solutions identified in FDA's regulations at 21 CFR 178.1010
remain subject to FFDCA section 409 regulations just as they did pre-
FQPA, while other uses are now subject to EPA's jurisdiction under
FFDCA section 408.
B. Why are these Tolerance Exemptions not Subject to Tolerance
Reassessment at this Time?
Under FFDCA section 408(q), EPA is required to reassess all
tolerance exemptions that were in effect on the day before the
enactment of the FQPA. The tolerance exemptions for inert ingredients
as well as those active ingredients not yet completed will be
reassessed in accordance with EPA's schedule for tolerance reassessment
published in the Federal Register of August 4, 1997 (62 FR 42019) (FRL-
5734-6).
The tolerance exemptions in this proposed rule to be codified in 40
CFR 180.940 already exist as valid FFDCA section 408 regulations. FDA
promulgated the food additive regulations in 21 CFR 178.1010 under the
authority of FFDCA section 409 prior to the enactment of FQPA. By
operation of FFDCA section 408(j)(2), those portions of 21 CFR 178.1010
that pertain to chemical substances that are pesticide chemicals post-
FQPA and remain as such post-ARTCA were converted to FFDCA section 408
tolerance exemptions. EPA's duplication of these tolerance exemptions
is not ``establishing, modifying, or revoking a tolerance'' under FFDCA
section 408(b). EPA is, therefore, not required to conduct a full
reassessment of these tolerance exemptions at this time.
C. Why is 40 CFR 180.940 being Created?
The Agency is duplicating in 40 CFR 180.940 only those portions of
the regulations in 21 CFR 178.1010 that pertain to pesticide chemicals.
This duplication will have no effect on any of FDA's regulated FFDCA
section 409 food additive regulations in 21 CFR 178.1010.
In establishing food additive regulations for food-contact surface
sanitizing solutions in 21 CFR 178.1010, FDA used a formulation-
specific approach. Consistent with its authority under FFDCA section
409, FDA issued regulations prescribing the conditions under which
food-contact surface sanitizing solutions might be safely used. FDA
approved the use of each food-contact surface sanitizing solution
formulation as a whole, rather than regulating each component chemical
substance individually. In addition, FDA included a generic exemption
for any chemical substance considered to be GRAS, and in some cases,
issued letters not objecting to certain additional chemical substances
in the formulations.
By contrast, FFDCA section 408 authorizes EPA to issue regulations
establishing tolerances or exemptions from the requirement of a
tolerance. EPA's practice has been to issue these regulations on a
chemical-specific basis, whereby each ingredient in the product is the
subject of a separate tolerance or exemption regulation. Food-contact
surface sanitizing solutions meet the requirements of FFDCA if each
ingredient has an appropriate clearance under FFDCA, either a tolerance
or an exemption from the requirement of a tolerance, and any conditions
on the clearance are observed.
Translating the regulatory decisions made by FDA into a comparable
EPA scheme requires considerably greater work on EPA's part than merely
copying those portions of the existing regulations in 21 CFR 178.1010
that pertain to pesticide chemicals directly into 40 CFR 180.940. EPA
must disaggregate the formulations in 21 CFR 178.1010 that pertain to
pesticide chemicals into their component ingredients. EPA must also
provide a mechanism to address those ingredients not identified by name
in 21 CFR 178.1010 but that were, for example, permitted by prior
sanction or approval, not objected to, or generally recognized as safe.
This, in fact, places a higher initial demand on EPA resources than
would be required to simply copy FDA's approach. However, EPA is
convinced that the long-term administrative convenience of using a
consistent regulatory scheme for all pesticide chemicals subject to
FFDCA section 408 outweighs the initial burdens.
FDA's formulation-specific approach is different from EPA's
chemical-specific approach. Under EPA's approach, a tolerance exemption
would be approved once for each particular pesticide chemical, and
would not need to be repeated as new products containing that chemical
substance enter the market. EPA's approval process is not complex, will
allow for a wide variety of potential products, and fosters innovative
formulation approaches. In addition, by listing in one place (40 CFR
180.940) all chemical substances exempted from the requirement of a
tolerance when used in food-contact surface sanitizing solutions, EPA's
approach will increase the transparency of its regulatory process.
This duplication will not allow any residues beyond those already
permitted by 21 CFR 178.1010. EPA believes that the chemical-specific
approach and FDA's formulation-specific approach are equivalent from a
risk management perspective, inasmuch as each would result in the same
levels of residues from these chemical substances.
As part of the duplication, EPA changed the naming conventions
(chemical nomenclature), as well as combining, as appropriate, chemical
substances that appear in 21 CFR 178.1010 under two or more names under
a single name. The Agency has attempted to identify each of the listed
chemical substances using the Chemical Abstracts Service Registry
Number (CAS No.). The CAS No. provides one of the most distinct and
universally accepted means of identifying chemical substances.
Generally, there will be only one CAS No. per listed chemical
substance; however, it is possible that more than one CAS No. may be
appropriate for some chemical substances. The lack of a CAS No. will
not preclude EPA from including chemical substances in 40 CFR 180.940.
The lower-concentration limits specified in 21 CFR 178.1010 are not
included in 40 CFR 180.940 because of the differences between FDA's
approach and EPA's approach. Although EPA establishes tolerance
exemptions for use in food-contact surface sanitizing solutions under
FFDCA, all pesticide products must also meet the criteria for
registration under the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) before being offered for sale. EPA relies on conditions
imposed through the FIFRA registration process to address safety and
for antimicrobial-formulated products efficacy. Accordingly, the lower
limits on concentrations of pesticide chemicals, that appear in 21 CFR
178.1010 will not appear in 40 CFR 180.940. Three types of food-contact
surface sanitizing
[[Page 37782]]
solutions are described in 21 CFR 178.1010:
? Those used on food-contact surfaces in public eating
places.
? Those used on dairy-processing equipment.
? Those used on food-processing equipment and utensils.
According to FDA, food-contact surface sanitizing solutions that
are acceptable for use on food-contact surfaces in public eating places
can also be used on dairy-processing equipment, and on food-processing
equipment and utensils. Food-contact surface sanitizing solutions that
are acceptable for use on dairy equipment can also be used on food-
processing equipment and utensils. EPA has separated the component
ingredients by both chemical and concentration for these three types of
food-contact surface sanitizing solutions, which will be included in 40
CFR 180.940.
IV. Issuance and Withdrawal of Direct Final Rule
In the Federal Register of December 3, 2002 (67 FR 71847) (FRL-
6824-2), the Agency published a direct final rule to establish 40 CFR
180.940. Comments were received. In the December 3, 2002 Federal
Register notice, EPA announced that it would withdraw the direct final
rule if it received adverse comment, and proceed with proposed rule as
provided by section 553 of the Administrative Procedure Act, 5 U.S.C.
553. Because some of the comments were of a nature that would warrant a
response if made on a proposed rule, they are adverse comments that
require withdrawal of the direct final rule. Accordingly, EPA withdrew
the direct final rule on March 24, 2003 (68 FR 14165) (FRL-7299-4).
Several of the comments reflected some understandable confusion on
the part of the commenters. While EPA's chemical-specific approach and
FDA's formulation specific approach are essentially equivalent, the two
approaches look and read differently. EPA disaggregated the 46
formulations in 21 CFR 178.1010 into a list of chemicals. This list of
chemicals was then subdivided into three separate lists based on use
categories in 21 CFR 178.1010 (i.e., food-contact surfaces in public
eating places, dairy processing equipment, and food-processing
equipment and utensils). The 40 CFR 180.940(a) list contains only the
chemicals specified in those formulations that were designated by FDA
for use in public eating places. The 40 CFR 180.940(b) list contains
only the chemicals specified in those formulations that were designated
by FDA for use on dairy equipment. The 40 CFR 180.940(c) list contains
all chemicals because all formulations in 21 CFR 178.1010 can be used
on food-processing equipment and utensils.
The maximum concentration level for each chemical was determined by
evaluating the range derived from the lists in 40 CFR 180.940(a), (b),
or (c). Where 21 CFR 178.1010 authorized several different sanitizing
solutions each containing a particular chemical, but at different
concentrations, EPA will use only the highest concentration as the
upper limit, reflecting FDA's implicit determination that
concentrations up to and including that limit do not compromise food
safety. As an example, if three solutions authorized under 21 CFR
178.1010 for use on dairy equipment contain chemical ``X'' at
concentrations of 150, 200, and 240 parts per million (ppm), then 240
ppm would be used as the upper limit in 40 CFR 180.940(b). If for
chemical ``Y,'' concentrations of 150 and 200 ppm were specified, but
in a third solution the concentration was not specified, then the upper
limit for chemical ``Y '' in 40 CFR 180.940(c) would be specified as
``none.'' This reflects FDA's implicit determination in regard to that
third sanitizing solution that chemical ``Y '' could be used in any
concentration without significant risk to food safety.
In addition to the disaggregation, the Agency also in some cases
used a different chemical nomenclature. CI (chemical index) names and
CAS Nos. were used to the greatest extent possible. This is part of an
Agency-wide effort to provide a common and consistent way to identify
and represent chemical substances across the Agency. Thus, sodium
hypochlorite became hypochlorous acid, sodium salt. In other instances
(most commonly involving polymers or quaternary ammonium compounds),
FDA approved in one solution a particular chemical that falls within a
more inclusive chemical designation approved in another solution. If
practicable in such instances, EPA has stated the tolerance exemption
only in terms of the more inclusive chemical designation, implicitly
exempting all chemical substances that fall within that designation.
For example, n-alkyl (C12-C16) benzyl dimethyl
ammonium chloride would be considered to be a subset of n-alkyl
(C12-C18) benzyl dimethyl ammonium chloride.
Another example, n-alkyl (C12-C18) benzyl
dimethyl ammonium chloride (mw 351 to 380) would also be considered a
subset of n-alkyl (C12-C18) benzyl dimethyl
ammonium chloride. Both of the example chemicals would be accounted for
under the nomenclature quaternary ammonium compounds alkyl
(C12-C18) benzyl dimethyl, chlorides. For each
comment questioning whether a particular chemical substance appeared in
the direct final rule, the Agency was able to verify that the chemical
for which the commenter expressed concern was included in 40 CFR
180.940, albeit under a different designation.
A commenter asked that instead of using the term ``oxychloro
species,'' that sodium chlorite or chlorine dioxide should be used
instead. The ``generated by'' language was considered to be confusing
in a listing of chemical names. The Agency (as acknowledged by the
commenter) used FDA's language, which is an approach which describes
the process for generating the solution, not the components of the
solution. If the end-products of the generation process were specific
chemicals already included in the other solutions (and therefore
already line-items), then the Agency used the disaggregated approach.
However, for the oxychloro species generation methods described in 21
CFR 178.1010(b)(34), the chlorite, chlorate, and/or chlorine dioxide is
actually an equilibrium mixture. There are no separate line-item
entries for these chemicals. In fact, the upper concentration limit is
specified in terms of chlorine dioxide only, thus making it difficult
to separate the chemicals into line items. The Agency determined
therefore to maintain the original FDA language at this time. The
Agency also considered that other generation methods for oxychloro
species could be submitted as part of the non-designated prior approved
chemical substances, which could impact the handling of this in the
future.
Several commenters asked if a specific combination of quaternary
ammonium compounds expressly identified in 21 CFR 178.1010(b)(22) were
included in 40 CFR 180.940. Each of the component chemicals identified
in 21 CFR 178.1010(b)(22) are identified in 40 CFR 180.940 as subject
to a tolerance exemption. The two components listed in 21 CFR
178.1010(b)(22) are di-n-alkyl (C8-C10)
dimethylammonium chloride (mw 332 to 361) and n-alkyl (C12-
C18) benzyl dimethyl ammonium chloride (mw 351 to 380). The
first chemical is listed in 40 CFR 180.940 as ``Quaternary ammonium
compounds, di-n-alkyl (C8-C10) dimethyl ammonium
chloride average molecular weight (in amu) 332 to 361.'' 21 CFR
178.1010(b)(22) and 21 CFR 178.1010(c)(17) together allow a maximum
end-use concentration of 400
[[Page 37783]]
ppm of the two quaternary ammonium compounds in this solution, of which
this particular chemical must comprise 60%. EPA's regulation exempts
this chemical substance from the requirement of a tolerance in
sanitizing solutions up to 240 ppm, which is 60% of the 400 ppm
authorized in the FDA regulations. The second chemical is listed in 40
CFR 180.940 as ``Quaternary ammonium compounds, alkyl (C12-
C18) benzyl dimethyl, chlorides.'' The end use concentration
as specified in 21 CFR 178.1010(b)(22) and 21 CFR 178.1010(c)(17) for
this chemical would be 40% of 400 ppm or 160 ppm. Because other
solutions in 21 CFR 178.1010 included chemical substances within the
description ``quaternary ammonium compounds, alkyl (C12-
C18) benzyl dimethyl, chlorides'' without molecular weight
limitations and/or with higher concentration limits, the description of
this chemical in 40 CFR 180.940 is more broad than that of 21 CFR
178.1010(b)(22).
Based on one comment, the Agency was made aware of a typographical
error in the December 3, 2002 Federal Register notice which has been
corrected in this notice of proposed rulemaking. In 40 CFR 180.940(a)
the upper limit should be not 150 ppm, but 200 ppm for C12-
C16 benzyl dimethyl ammonium chloride (mw 351-380). With the
change in upper limit to 200 ppm, C12-C16 benzyl
dimethyl ammonium chloride (mw 351 to 380) can be appropriately held
under the more inclusive quaternary ammonium compounds alkyl
(C12-C18) benzyl dimethyl, chlorides.
Another commenter requested that the Agency change the language
describing the upper limit concentration for all quaternary ammonium
compounds. The commenter has suggested the use of the phrase ``when
ready to use, the end-use concentration is not expected to exceed `X'
ppm of this active quaternary ammonium compound,'' instead of the
phrasing used by the Agency ``when ready for use, concentration is not
to exceed `X' ppm of active quaternary compound.'' The commenter cited
the concern that state enforcement personnel would apply the limitation
for a particular quaternary ammonium compound to a mixture. The Agency
believes that the language it has used is clear and concise. The
concentration limits specified in 40 CFR 180.940 apply only to the
chemical substance described in the particular table entry. However,
the 30-day comment period will allow the Agency to take further comment
on this issue.
A commenter asked that the Agency not distinguish between food-
contact surfaces in public eating places, dairy-processing equipment,
and food processing equipment and utensils. These categories were
originally created by the FDA and reflect different assumptions
especially with regard to dietary exposure to sanitizer residues, and
thus are an intrinsic part of FDA's risk assessments. Although EPA has
the authority to reconsider FDA's risk assessments, EPA can do so only
upon fully reassessing these tolerance exemptions in accordance with
FFDCA section 408, as amended by FQPA. EPA is not reassessing these
tolerance exemptions at this time, but instead merely duplicating FDA's
previous clearances in a format consistent with EPA's authority under
FFDCA section 408. EPA is required under FFDCA section 408(q)(1)(C) to
complete tolerance reassessment for all pesticide chemicals by 2006,
and will consider the commenter's suggestion during tolerance
reassessment.
Although not raised by commenters, EPA has made three additional
changes from the December 3, 2003 Federal Register notice. D&C Blue
No.1 (methylene blue) is now referenced as methylene blue. Similarly,
FD&C Yellow No. 5 (tartrazine) is now referenced as FD&C Yellow No. 5.
A CAS No. was added to one entry (quaternary ammonium compounds, alkyl
(C12-C18) benzyl dimethyl, chlorides) in 40 CFR
180.940(a).
V. Addition of Non-Designated, Prior Approved Chemical Substances
21 CFR 178.1010 allows the use of GRAS chemical substances and
chemical substances ``permitted by prior sanction or approval,'' that
are not expressly identified. These chemical substances were subject to
the sanitizer formulation approval under FDA's regulation before these
uses became FFDCA section 408 tolerance exemptions under FFDCA section
408(j)(2). Accordingly, many food-contact sanitizing solutions that
presently are authorized for use under 21 CFR 178.1010 contain
ingredients which are not identified in this direct final rule. As
discussed in this unit, EPA is asking registrants to identify these
other ingredients that they believe should be included in 40 CFR
180.940. EPA intends to publish a revision to 40 CFR 180.940 adding
these chemical substances. In the interim, to preserve the use of food-
contact surface sanitizing solutions that were cleared for use before
FQPA's enactment and that contain chemical substances that are not
specifically identified in 21 CFR 178.1010, EPA has decided to honor
those approvals under 21 CFR 178.1010 until EPA has received and
reviewed registrant's claims with respect to unspecified pesticide
chemicals, as discussed in this unit.
FDA's regulations (21 CFR 178.1010(b)) allowed the addition to
food-contact surface sanitizing solutions of GRAS components, and
components permitted by prior sanction or approval or subject to a
letter of no objection. Much of this information should be in EPA's
files. The Agency will access this information. However, EPA may not
have ready access to all information on all chemicals in existing food-
contact surface sanitizing solution formulations which could meet these
criteria. Submission of this information to EPA would also reduce the
possibility of an existing food-contact surface sanitizing solution
having a component that lacks a tolerance exemption under 40 CFR
180.940. Therefore, registrants who believe that components of their
food-contact surface sanitizing solutions are exempted under 21 CFR
178.1010(b) should advise EPA in writing that these chemical substances
(along with the CAS No.) should be included in 40 CFR 180.940. The
submission of this information facilitates EPA's process for adding
these chemical substances cleared under 21 CFR 178.1010(b), but not
specifically listed by name, to 40 CFR 180.940. The EPA will also need
any available information documenting the claim that the component is
GRAS, prior sanctioned or approved, or subject to a letter of no
objection.
Claims and supporting documentation should be sent to the person
listed under FOR FURTHER INFORMATION CONTACT. Claims are not comments
on this direct final rule and should be identified on the subject line
as ``Submission of Non-designated Prior Approved Chemical Substance.''
If you have any questions about the many types of information that
could be submitted please consult the person listed under FOR FURTHER
INFORMATION CONTACT. The Agency does not anticipate that registrants
will be required to submit an excessive amount of information, and, in
fact, believes that most registrants will be able to submit the
necessary information with minimal effort. EPA will review and evaluate
the information provided. Chemical substances identified in claims
received not later than October 1, 2003, may be eligible for inclusion
in 40 CFR 180.940 under FFDCA section 408(j)(2). EPA anticipates
publishing a notice of proposed rulemaking identifying those chemical
substances shortly after that date.
[[Page 37784]]
VI. Statutory and Executive Order Reviews
This proposed rule would add a new Sec. 180.940 to 40 CFR part
180, subpart D, which lists the pesticide chemicals that are exempt
from the requirement of a tolerance when used in food-contact surface
sanitizing solutions. The initial list duplicates pesticide chemicals
in 40 CFR 180.940 that are active and inert ingredients listed in 21
CFR 178.1010. Since this proposed rule does not impose any new
requirements, it is not subject to review by the Office of Management
and Budget (OMB) under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993).
Because this proposed rule has been exempted from review under
Executive Order 12866 due to its lack of significance, this proposed
rule is not subject to Executive Order 13211, Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001).
This proposed rule does not impose any enforceable duty or contain
any unfunded mandate as described under Title II of the Unfunded
Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).
Nor does it require any special considerations under Executive
Order 12898, entitled Federal Actions to Address Environmental Justice
in Minority Populations and Low-Income Populations (59 FR 7629,
February 16, 1994); or OMB review or any Agency action under Executive
Order 13045, entitled Protection of Children from Environmental Health
Risks and Safety Risks (62 FR 19885, April 23, 1997). This action does
not involve any technical standards that would require Agency
consideration of voluntary consensus standards pursuant to section
12(d) of the National Technology Transfer and Advancement Act of 1995
(NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
In addition, the Agency has determined that this action will not
have a substantial direct effect on States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government, as
specified in Executive Order 13132, entitled Federalism (64 FR 43255,
August 10, 1999). Executive Order 13132 requires EPA to develop an
accountable process to ensure ``meaningful and timely input by State
and local officials in the development of regulatory policies that have
federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This proposed rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of the FFDCA. For these same reasons, the Agency
has determined that this proposed rule does not have any ``tribal
implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR 67249,
November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
Under section 605(b) of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby certifies that the creation of a
new section 180.940 will not have significant negative economic impact
on a substantial number of small entities. The rationale supporting
this conclusion is as follows. This proposed rule does not impose any
requirements, it establishes exemptions from the requirement for a
tolerance. The Agency is, however, also commencing a process whereby
EPA will require certain persons to identify chemical substances
considered to be GRAS (which could include self-affirmed GRAS
chemicals), or permitted by prior sanction or approval in existing food
contact surface sanitizing solutions. The information available to the
Agency indicates that fewer than 500 companies have approximately 1,300
products that could fall under this category. EPA anticipates the
economic burden on small entities to be minor, since the Agency is only
asking for confirmation that the chemical substances considered to be
GRAS or permitted by prior sanction or approval in existing food
contact surface sanitizing solutions are in fact part of an existing
formulation, and information as to why the chemical is considered to be
GRAS, or a copy of an FDA letter not objecting to the use of a chemical
substance. By contrast, this proposed rule will be beneficial to the
regulated community by increasing the number of inert ingredients for
use in antimicrobial formulations and by reducing the regulatory burden
on persons seeking to market new combinations of ingredients for
certain hard surface sanitizing solutions. Additionally, this proposed
rule will provide a more transparent listing of pesticide chemicals
used in food-contact surface sanitizing solutions to the public.
According to the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., an Agency may not conduct or sponsor, and a person is not
required to respond to a collection of information that requires OMB
approval under the PRA, unless it has been approved by OMB and displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations, after initial display in the preamble of the final rule
and in addition to its display on any related collection instrument,
are listed in 40 CFR part 9.
This proposed rule does not impose any new information collection
requirements that would require separate approval by OMB under the PRA.
Under 5 CFR 1320.3(h), the request for information discussed in Unit V.
is not subject to approval under the PRA, and the information
collection activities related to the Agency's tolerance exemption
process have already been approved by OMB under OMB control numbers
2070-0024 (EPA ICR No. 597). The annual ``respondent'' (petitioner)
burden for the pesticide tolerance petitions program is estimated to
average 1,726 hours per petition. According to the PRA, ``burden''
means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency. For this collection, it is the
time reading the regulations, planning the necessary data collection
activities, conducting tests, analyzing data, generating reports and
completing other
[[Page 37785]]
required paperwork, and storing, filing, and maintaining the data. Send
comments regarding this burden estimate or any other aspect of the
collection activity, including suggestions for reducing the burden to:
Director, Collection Strategies Division (2822), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001. Include the OMB control number 2070-0024 in any correspondence
about this collection activity, but do not submit the requested
information or forms to this address.
List of Subjects in 40 CFR Part 180
Environmental protection, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: June 11, 2003.
James Jones,
Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 continues to read as
follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. A new Sec. 180.940 is added to subpart D of part 180 to read as
follows.
Sec. 180.940 Food-contact surface sanitizing solutions; exemptions
from the requirement of a tolerance.
Residues of the following chemical substances are exempted from the
requirement of a tolerance when used in accordance with good
manufacturing practice as ingredients in an antimicrobial pesticide
formulation, provided that the chemical substance is applied on a semi-
permanent or permanent food-contact surface (other than being applied
on food packaging) with adequate draining before contact with food.
(a) The following chemical substances when used as ingredients in
an antimicrobial pesticide formulation may be applied to: Food-contact
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils.
------------------------------------------------------------------------
Pesticide chemical CAS No. Limits
------------------------------------------------------------------------
Acetic acid 64-19-7 When ready for use,
the end-use
concentration is not
to exceed 290 parts
per million (ppm)
------------------------------------------------------------------------
[alpha]-Alkyl(C10-C14)-w None None
-hydroxypoly(oxyethylene)
poly (oxypropylene) average
molecular weight (in amu),
768 to 837
------------------------------------------------------------------------
[alpha]-Alkyl(C12-C18)-w None None
-hydroxypoly(oxyethylene)
poly(oxypropylene) average
molecular weight (in amu),
950 to 1,120
------------------------------------------------------------------------
Ammonium chloride 12125-02-9 When ready for use,
the end-use
concentration is not
to exceed 48 ppm
------------------------------------------------------------------------
Dextrin 9004-53-9 When ready for use,
the end-use
concentration is not
to exceed 16 ppm
------------------------------------------------------------------------
Ethanol 64-17-5 None
------------------------------------------------------------------------
Ethylenediaminetetraacetic 64-02-8 None
acid (EDTA), tetrasodium salt
------------------------------------------------------------------------
Hydrogen peroxide 7722-84-1 When ready for use,
the end-use
concentration is not
to exceed 91 ppm
------------------------------------------------------------------------
Hypochlorous acid, sodium salt 7681-52-9 When ready for use,
the end-use
concentration is not
to exceed 200 ppm
determined as total
available chlorine
------------------------------------------------------------------------
Iodine 7553-56-2 When ready for use,
the end-use
concentration is not
to exceed 25 ppm of
titratable iodine
------------------------------------------------------------------------
Magnesium oxide 1309-48-4 None
------------------------------------------------------------------------
Methylene blue 61-73-4 When ready for use,
the end-use
concentration is not
to exceed 0.4 ppm
------------------------------------------------------------------------
[alpha]-(p-Nonylphenyl)-w None None
-hydroxypoly(oxyethylene)
average poly(oxyethylene)
content 11 moles)
------------------------------------------------------------------------
Octadecanoic acid, calcium 1592-23-0 When ready for use,
salt the end-use
concentration is not
to exceed 16 ppm
------------------------------------------------------------------------
1-Octanesulfonic acid, sodium 5324-84-5 When ready for use,
salt the end-use
concentration is not
to exceed 46 ppm of
total active fatty
acids
------------------------------------------------------------------------
Octanoic acid 124-07-2 When ready for use,
the end-use
concentration is not
to exceed 52 ppm of
total active fatty
acids
------------------------------------------------------------------------
Oxirane, methyl-, polymer with 9003-11-6 None
oxirane, minimum molecular
weight (in amu), 1,900
------------------------------------------------------------------------
[[Page 37786]]
Peroxyacetic acid 79-21-0 When ready for use,
the end-use
concentration is not
to exceed 58 ppm
------------------------------------------------------------------------
Peroxyoctanoic acid 33734-57-5 When ready for use,
the end-use
concentration is not
to exceed 52 ppm
------------------------------------------------------------------------
Phosphonic acid, (1- 2809-21-4 When ready for use,
hydroxyethylidene)bis- the end-use
concentration is not
to exceed 14 ppm
------------------------------------------------------------------------
Phosphoric acid, trisodium 7601-54-9 When ready for use,
salt the end-use
concentration is not
to exceed 5,916 ppm
------------------------------------------------------------------------
Potassium bromide 7758-02-3 When ready for use,
the end-use
concentration is not
to exceed 46 ppm
total available
halogen
------------------------------------------------------------------------
Potassium iodide 7681-11-0 When ready for use,
the end-use
concentration is not
to exceed 25 ppm of
titratable iodine
------------------------------------------------------------------------
Potassium permanganate 7722-64-7 When ready for use,
the end-use
concentration is not
to exceed 0.7 ppm
------------------------------------------------------------------------
2-Propanol (isopropanol) 67-63-0 None
------------------------------------------------------------------------
Quaternary ammonium compounds, 8001-54-5 When ready for use,
alkyl (C12-C18) benzyl the end-use
dimethyl, chlorides concentration is not
to exceed 200 ppm of
active quaternary
compound
------------------------------------------------------------------------
Quaternary ammonium compounds, None When ready for use,
n-alkyl (C12-C14) dimethyl the end-use
ethylbenzyl ammonium concentration is not
chloride, average molecular to exceed 200 ppm of
weight (in amu), 377 to 384 active quaternary
compound
------------------------------------------------------------------------
Quaternary ammonium compounds None When ready for use,
n-alkyl (C12-C18) dimethyl the end-use
ethylbenzyl ammonium chloride concentration is not
average molecular weight (in to exceed 200 ppm of
amu), 384 active quaternary
compound
------------------------------------------------------------------------
Quaternary ammonium compounds None When ready for use,
di-n-alkyl (C8-C10) dimethyl the end-use
ammonium chloride, average concentration is not
molecular weight (in amu), to exceed 150 ppm of
332 to 361 active quaternary
compound
------------------------------------------------------------------------
Sodium bicarbonate 144-55-8 When ready for use,
the end-use
concentration is not
to exceed 120 ppm
------------------------------------------------------------------------
Starch 9005-25-8 When ready for use,
the end-use
concentration is not
to exceed 16 ppm
------------------------------------------------------------------------
Sulfuric acid monododecyl 151-21-3 When ready for use,
ester, sodium salt (sodium the end-use
lauryl sulfate) concentration is not
to exceed 3 ppm
------------------------------------------------------------------------
1,3,5-Triazine-2,4,6(1H,3H,5H)- 2893-78-9 When ready for use,
trione, 1,3-dichloro-, sodium the end-use
salt concentration is not
to exceed 100 ppm
determined as total
available chlorine
------------------------------------------------------------------------
(b) The following chemical substances when used as ingredients in
an antimicrobial pesticide formulation may be applied to: Dairy-
processing equipment and food-processing equipment and utensils.
------------------------------------------------------------------------
Pesticide chemical CAS No. Limits
------------------------------------------------------------------------
Acetic acid 64-19-7 When ready for use,
the end-use
concentration is not
to exceed 686 ppm
------------------------------------------------------------------------
Acetic acid, chloro-, sodium 68608-66-2 When ready for use,
salt, reaction products with the end-use
4,5-dihydro-2-undecyl-1H- concentration is not
imidazole-1-ethanol and to exceed 42 ppm
sodium hydroxide chloroacetic acid
------------------------------------------------------------------------
Benzenesulfonic acid, dodecyl- 27176-87-0 When ready for use,
the end-use
concentration is not
to exceed 5.5 ppm
------------------------------------------------------------------------
Butanedioic acid, octenyl- 28805-58-5 When ready for use,
the end-use
concentration is not
to exceed 156 ppm
------------------------------------------------------------------------
Butoxy monoether of mixed None None
(ethylene-propylene)
polyalkylene glycol, minimum
average molecular weight (in
amu), 2400
------------------------------------------------------------------------
Calcium chloride 10043-52-4 When ready for use,
the end-use
concentration is not
to exceed 17 ppm
------------------------------------------------------------------------
[[Page 37787]]
n-Carboxylic acids (C6-C12), None When ready for use,
consisting of a mixture of the end-use
not less than 56% octanoic concentration is not
acid and not less than 40% to exceed 39 ppm
decanoic acid
------------------------------------------------------------------------
Citric acid 77-92-9 None
------------------------------------------------------------------------
Decanoic acid 334-48-5 When ready for use,
the end-use
concentration is not
to exceed 90 ppm
total active fatty
acids
------------------------------------------------------------------------
Ethanesulfonic acid, 2- 132-43-4 When ready for use,
[cyclohexyl (1- the end-use
oxohexadecyl)amino]-, sodium concentration is not
salt to exceed 237 ppm
------------------------------------------------------------------------
Ethylenediaminetetraacetic 139-33-3 When ready for use,
acid (EDTA), disodium salt the end-use
concentration is not
to exceed 1,400 ppm
------------------------------------------------------------------------
FD&C Yellow No. 5 (conforming 1934-21-0 None
to 21 CFR 74.705)
------------------------------------------------------------------------
D-Gluconic acid, monosodium 527-07-1 When ready for use,
salt the end-use
concentration is not
to exceed 760 ppm
------------------------------------------------------------------------
Hydriodic acid 10034-85-2 When ready for use,
the end-use
concentration is not
to exceed 25 ppm of
titratable iodine
------------------------------------------------------------------------
Hydrogen peroxide 7722-84-1 When ready for use,
the end-use
concentration is not
to exceed 465 ppm
------------------------------------------------------------------------
Hypochlorous acid 7790-92-3 When ready for use,
the end-use
concentration is not
to exceed 200 ppm
determined as total
available chlorine
------------------------------------------------------------------------
Iodine 7553-56-2 When ready for use,
the end-use
concentration is not
to exceed 25 ppm of
titratable iodine
------------------------------------------------------------------------
Lactic acid 50-21-5 When ready for use,
the end-use
concentration is not
to exceed 138 ppm
------------------------------------------------------------------------
[alpha]-Lauroyl-w None None
-hydroxypoly (oxyethylene)
with an average of 8-9 moles
ethylene oxide, average
molecular weight (in amu),
400
------------------------------------------------------------------------
Nonanoic acid 112-05-0 When ready for use,
the end-use
concentration is not
to exceed 90 ppm
------------------------------------------------------------------------
1-Octanamine, N,N-dimethyl- 7378-99-6 When ready for use,
the end-use
concentration is not
to exceed 113 ppm
------------------------------------------------------------------------
1,2-Octanedisulfonic acid 113669-58-2 When ready for use,
the end-use
concentration is not
to exceed 102 ppm
------------------------------------------------------------------------
1-Octanesulfonic acid 3944-72-7 When ready for use,
the end-use
concentration is not
to exceed 172 ppm
------------------------------------------------------------------------
1-Octanesulfonic acid, sodium 5324-84-5 When ready for use,
salt the end-use
concentration is not
to exceed 297 ppm
------------------------------------------------------------------------
1-Octanesulfonic acid, 2- 113652-56-5 When ready for use,
sulfino- the end-use
concentration is not
to exceed 102 ppm
------------------------------------------------------------------------
Octanoic acid 124-07-2 When ready for use,
the end-use
concentration is not
to exceed 176 ppm of
total active fatty
acids
------------------------------------------------------------------------
Oxirane, methyl-, polymer with 11111-34-5 When ready for use,
oxirane, ether with (1,2- the end-use
ethanediyldinitrilo)tetrakis[ concentration is not
propanol]
(4:1) to exceed 20 ppm in
the formulated
product
------------------------------------------------------------------------
Oxychloro species (including None When ready for use,
chlorine dioxide) generated the end-use
by acidification of an concentration is not
aqueous solution of sodium to exceed 200 ppm of
chlorite chlorine dioxide as
determined by the
method entitled,
``Iodometric Method
for the
Determination of
Available Chlorine
Dioxide'' (50-250
ppm available
chlorine dioxide)
------------------------------------------------------------------------
Peroxyacetic acid 79-21-0 When ready for use,
the end-use
concentration is not
to exceed 315 ppm
------------------------------------------------------------------------
Peroxyoctanoic acid 33734-57-5 When ready for use,
the end-use
concentration is not
to exceed 122 ppm
------------------------------------------------------------------------
[[Page 37788]]
Phosphonic acid, (1- 2809-21-4 When ready for use,
hydroxyethylidene)bis- the end-use
concentration is not
to exceed 34 ppm
------------------------------------------------------------------------
Phosphoric acid 7664-38-2 None
------------------------------------------------------------------------
Phosphoric acid, monosodium 7558-80-7 When ready for use,
salt the end-use
concentration is not
to exceed 350 ppm
------------------------------------------------------------------------
Potassium iodide 7681-11-0 When ready for use,
the end-use
concentration is not
to exceed 25 ppm of
titratable iodine
------------------------------------------------------------------------
Propanoic acid 79-09-4 When ready for use,
the end-use
concentration is not
to exceed 297 ppm
------------------------------------------------------------------------
2-Propanol (isopropanol) 67-63-0
------------------------------------------------------------------------
2,6-Pyridinedicarboxylic acid 499-83-2 When ready for use,
the end-use
concentration is not
to exceed 1.2 ppm
------------------------------------------------------------------------
Sodium mono-and None When ready for use,
didodecylphenoxy- the end-use
benzenedisulfonate concentration is not
to exceed 1,920 ppm
------------------------------------------------------------------------
Sulfuric acid 7664-93-9 When ready for use,
the end-use
concentration is not
to exceed 288 ppm
------------------------------------------------------------------------
Sulfuric acid monododecyl 151-21-3 When ready for use,
ester, sodium salt (sodium the end-use
lauryl sulfate) concentration is not
to exceed 350 ppm
------------------------------------------------------------------------
(c) The following chemical substances when used as ingredients in
an antimicrobial pesticide formulation may be applied to: Food-
processing equipment and utensils.
------------------------------------------------------------------------
Pesticide chemical CAS No. Limits
------------------------------------------------------------------------
Acetic acid 64-19-7 When ready for use,
the end-use
concentration is not
to exceed 686 ppm
------------------------------------------------------------------------
Acetic acid, chloro-, sodium 68608-66-2 When ready for use,
salt, reaction products with the end-use
4,5-dihydro-2-undecyl-1H- concentration is not
imidazole-1-ethanol and to exceed 42 ppm
sodium hydroxide chloroacetic acid
------------------------------------------------------------------------
[alpha]-Alkyl(C10-C14)-w None None
-hydroxypoly(oxyethylene)
poly (oxypropylene) average
molecular weight (in amu),
768 to 837
------------------------------------------------------------------------
[alpha]-Alkyl(C11-C15)-w None None
-hydroxypoly(oxyethylene)
with ethylene oxide content 9
to 13 moles
------------------------------------------------------------------------
[alpha]-Alkyl(C12-C15)-w None None
-hydroxypoly (oxyethylene)
polyoxypropylene, average
molecular weight (in amu),
965
------------------------------------------------------------------------
[alpha]-Alkyl(C12-C18)-w None None
-hydroxypoly(oxyethylene)
poly(oxypropylene) average
molecular weight (in amu),
950 to 1,120
------------------------------------------------------------------------
Alkyl (C12-C15) monoether of None None
mixed (ethylene-propylene)
polyalkylene glycol, cloud
point of 70-77 [deg]C in 1%
aqueous solution, average
molecular weight (in amu),
807
------------------------------------------------------------------------
Ammonium chloride 12125-02-9 When ready for use,
the end-use
concentration is not
to exceed 48 ppm
------------------------------------------------------------------------
Benzenesulfonamide, N-chloro-4- 127-65-1 None
methyl, sodium salt
------------------------------------------------------------------------
Benzenesulfonic acid, dodecyl- 27176-87-0 When ready for use,
the end-use
concentration is not
to exceed 400 ppm
------------------------------------------------------------------------
Benzenesulfonic acid, dodecyl- 25155-30-0 When ready for use,
, sodium salt the end-use
concentration is not
to exceed 430 ppm
------------------------------------------------------------------------
Benzenesulfonic acid, 30260-73-2 When ready for use,
oxybis[dodecyl- the end-use
concentration is not
to exceed 474 ppm
------------------------------------------------------------------------
[1,1'-Biphenyl]-2-ol 90-43-7 When ready for use,
the end-use
concentration is not
to exceed 400 ppm
------------------------------------------------------------------------
[[Page 37789]]
Boric acid, sodium salt 7775-19-1
------------------------------------------------------------------------
Butanedioic acid, octenyl- 28805-58-5 When ready for use,
the end-use
concentration is not
to exceed 156 ppm
------------------------------------------------------------------------
Butanedioic acid, sulfo-, 1,4- 1639-66-3 None
dioctyl ester, sodium salt
------------------------------------------------------------------------
Butoxy monoether of mixed None None
(ethylene-propylene)
polyalkylene glycol,
cloudpoint of 90-100 [deg]C
in 0.5 aqueous solution,
average molecular weight (in
amu), 3,300
------------------------------------------------------------------------
Butoxy monoether of mixed None None
(ethylene-propylene)
polyalkylene glycol, minimum
average molecular weight (in
amu), 2,400
------------------------------------------------------------------------
Calcium bromide 7789-41-5 When ready for use,
the end-use
concentration is not
to exceed 200 ppm
total available
halogen
------------------------------------------------------------------------
Calcium chloride 10043-52-4 When ready for use,
the end-use
concentration is not
to exceed 17 ppm
------------------------------------------------------------------------
n-Carboxylic acids (C6-C12), None When ready for use,
consisting of a mixture of the end-use
not less than 56% octanoic concentration is not
acid and not less than 40% to exceed 39 ppm
decanoic acid
------------------------------------------------------------------------
Citric acid 77-92-9 None
------------------------------------------------------------------------
3-Cyclohexene-1-methanol, 98-55-5 None
[alpha],[alpha],4-trimethyl-
------------------------------------------------------------------------
1-Decanaminium, N-decyl-N, N- 7173-51-5 When ready for use,
dimethyl-, chloride the end-use
concentration is not
to exceed 200 ppm of
active quaternary
compound
------------------------------------------------------------------------
Decanoic acid 334-48-5 When ready for use,
the end-use
concentration is not
to exceed 234 ppm
total active fatty
acids
------------------------------------------------------------------------
Dextrin 9004-53-9 When ready for use,
the end-use
concentration is not
to exceed 16 ppm
------------------------------------------------------------------------
Ethanesulfonic acid, 2- 132-43-4 When ready for use,
[cyclohexyl (1- the end-use
oxohexadecyl)amino]-, sodium concentration is not
salt to exceed 237 ppm
------------------------------------------------------------------------
Ethanol 64-17-5 None
------------------------------------------------------------------------
Ethanol, 2 butoxy- 111-76-2 None
------------------------------------------------------------------------
Ethanol, 2-(2-ethoxyethoxy)- 111-90-0 None
------------------------------------------------------------------------
Ethylenediaminetetraacetic 139-33-3 When ready for use,
acid (EDTA), disodium salt the end-use
concentration is not
to exceed 1,400 ppm
------------------------------------------------------------------------
Ethylenediaminetetraacetic 64-02-8 None
acid (EDTA), tetrasodium salt
------------------------------------------------------------------------
Fatty acids, coco, potassium 61789-30-8 None
salts
------------------------------------------------------------------------
Fatty acids, tall-oil, 68309-27-3 When ready for use,
sulfonated, sodium salts the end-use
concentration is not
to exceed 66 ppm
------------------------------------------------------------------------
FD&C Yellow No. 5 (conforming 1934-21-0 None
to 21 CFR 74.705)
------------------------------------------------------------------------
D-Gluconic acid, monosodium 527-07-1 When ready for use,
salt the end-use
concentration is not
to exceed 760 ppm
------------------------------------------------------------------------
Hydriodic acid 10034-85-2 When ready for use,
the end-use
concentration is not
to exceed 25 ppm of
titratable iodine
------------------------------------------------------------------------
Hydrogen peroxide 7722-84-1 When ready for use,
the end-use
concentration is not
to exceed 1,100 ppm
------------------------------------------------------------------------
Hypochlorous acid 7790-92-3 When ready for use,
the end-use
concentration is not
to exceed 200 ppm
determined as total
available chlorine
------------------------------------------------------------------------
Hypochlorous acid, calcium 7778-54-3 When ready for use,
salt the end-use
concentration is not
to exceed 200 ppm
determined as total
available chlorine
------------------------------------------------------------------------
[[Page 37790]]
Hypochlorous acid, lithium 13840-33-0 When ready for use,
salt the end-use
concentration is not
to exceed 200 ppm
determined as total
available chlorine
and 30 ppm lithium
------------------------------------------------------------------------
Hypochlorous acid, potassium 7778-66-7 When ready for use,
salt the end-use
concentration is not
to exceed 200 ppm
determined as
available chlorine
------------------------------------------------------------------------
Hypochlorous acid, sodium salt 7681-52-9 When ready for use,
the end-use
concentration is not
to exceed 200 ppm
determined as
available chlorine
------------------------------------------------------------------------
Iodine 7553-56-2 When ready for use,
the end-use
concentration is not
to exceed 25 ppm of
titratable iodine
------------------------------------------------------------------------
Lactic acid 50-21-5 None
------------------------------------------------------------------------
[alpha]-Lauroyl-w None None
-hydroxypoly (oxyethylene)
with an average of 8-9 moles
ethylene oxide, average
molecular weight (in amu),
400
------------------------------------------------------------------------
Magnesium oxide 1309-48-4 None
------------------------------------------------------------------------
Methylene blue 61-73-4 When ready for use,
the end-use
concentration is not
to exceed 0.4 ppm
------------------------------------------------------------------------
Naphthalene sulfonic acid, 1321-69-3 When ready for use,
sodium salt the end-use
concentration is not
to exceed 332 ppm
total naphthalene
sulfonates
------------------------------------------------------------------------
Naphthalene sulfonic acid None When ready for use,
sodium salt, and its methyl, the end-use
dimethyl and trimethyl concentration is not
derivatives to exceed 332 ppm
total naphthalene
sulfonates
------------------------------------------------------------------------
Naphthalene sulfonic acid None When ready for use,
sodium salt, and its methyl, the end-use
dimethyl and trimethyl concentration is not
derivatives alkylated at 3% to exceed 332 ppm
by weight with C6-C9 linear total naphthalene
olefins sulfonates
------------------------------------------------------------------------
Neodecanoic acid 26896-20-8 When ready for use,
the end-use
concentration is not
to exceed 174 ppm
------------------------------------------------------------------------
Nonanoic acid 112-05-0 When ready for use,
the end-use
concentration is not
to exceed 90 ppm
------------------------------------------------------------------------
[alpha]-(p-Nonylphenyl)-w None None
-hydroxypoly(oxyethylene)
maximum average molecular
weight (in amu), 748
------------------------------------------------------------------------
[alpha]-(p-Nonylphenol)-w None None
-hydroxypoly(oxyethylene)
average poly(oxyethylene)
content 11 moles
------------------------------------------------------------------------
[alpha]-(p-Nonylphenyl)-w None None
-hydroxypoly(oxyethylene)
produced by the condensation
of 1 mole p-nonylphenol with
9 to12 moles ethylene oxide
------------------------------------------------------------------------
[alpha]-(p-Nonylphenyl)-w None None
-hydroxypoly(oxyethylene), 9
to 13 moles ethylene oxide
------------------------------------------------------------------------
Octadecanoic acid, calcium 1592-23-0 When ready for use,
salt the end-use
concentration is not
to exceed 16 ppm
------------------------------------------------------------------------
9-Octadecenoic acid (9Z)-, 68988-76-1 When ready for use,
sulfonated the end-use
concentration is not
to exceed 312 ppm
------------------------------------------------------------------------
9-Octadecenoic acid (9Z)- 68443-05-0 When ready for use,
sulfonated, sodium salts the end-use
concentration is not
to exceed 200 ppm
------------------------------------------------------------------------
1-Octanamine, N,N-dimethyl- 7378-99-6 When ready for use,
the end-use
concentration is not
to exceed 113 ppm
------------------------------------------------------------------------
1,2-Octanedisulfonic acid 113669-58-2 When ready for use,
the end-use
concentration is not
to exceed 102 ppm
------------------------------------------------------------------------
1-Octanesulfonic acid 3944-72-7 When ready for use,
the end-use
concentration is not
to exceed 172 ppm
------------------------------------------------------------------------
1-Octanesulfonic acid, sodium 5324-84-5 When ready for use,
salt the end-use
concentration is not
to exceed 312 ppm
------------------------------------------------------------------------
[[Page 37791]]
1-Octanesulfonic acid, 2- 113652-56-5 When ready for use,
sulfino- the end-use
concentration is not
to exceed 102 ppm
------------------------------------------------------------------------
Octanoic acid 124-07-2 When ready for use,
the end-use
concentration is not
to exceed 234 ppm of
total active fatty
acids
------------------------------------------------------------------------
Oxirane, methyl-, polymer with 9003-11-6 None
oxirane, minimum molecular
weight (in amu), 1,900
------------------------------------------------------------------------
Oxirane, methyl-, polymer with 106392-12-5 None
oxirane, block, average
molecular weight (in amu),
1,900
------------------------------------------------------------------------
Oxirane, methyl-, polymer with None None
oxirane, block, minimum
average molecular weight (in
amu), 2,000
------------------------------------------------------------------------
Oxirane, methyl-, polymer with None None
oxirane, block, 27 to 31
moles of polyoxypropylene,
average molecular weight (in
amu) 2,000
------------------------------------------------------------------------
Oxirane, methyl-, polymer with 11111-34-5 When ready for use,
oxirane, ether with (1,2- the end-use
ethanediyldinitrilo)tetrakis[ concentration is not
propanol]
(4:1) to exceed 20 ppm
------------------------------------------------------------------------
Oxychloro species None When ready for use,
(predominantly chlorite, the end-use
chlorate and chlorine dioxide concentration is not
in an equilibrium mixture) to exceed 200 ppm of
generated either: By directly chlorine dioxide as
metering a concentrated determined by the
chlorine dioxide solution method entitled,
prepared just prior to use, ``Iodometric Method
into potable water, or by for the
acidification of an aqueous Determination of
alkaline solution of Available Chlorine
oxychloro species Dioxide'' (50-250
(predominately chlorite and ppm available
chlorate) followed by chlorine dioxide)
dilution with potable water
------------------------------------------------------------------------
Oxychloro species (including None When ready for use,
chlorine dioxide) generated the end-use
by acidification of an concentration is not
aqueous solution of sodium to exceed 200 ppm of
chlorite chlorine dioxide as
determined by the
method entitled,
``Iodometric Method
for the
Determination of
Available Chlorine
Dioxide'' (50-250
ppm available
chlorine dioxide)
------------------------------------------------------------------------
2,4-Pentanediol, 2-methyl- 107-41-5 None
------------------------------------------------------------------------
Peroxyacetic acid 79-21-0 When ready for use,
the end-use
concentration is not
to exceed 315 ppm in
the formulated
product
------------------------------------------------------------------------
Peroxyoctanoic acid 33734-57-5 When ready for use,
the end-use
concentration is not
to exceed 122 ppm
------------------------------------------------------------------------
Phenol, 4-chloro-2- 120-32-1 When ready for use,
(phenylmethyl)- the end-use
concentration is not
to exceed 320 ppm
------------------------------------------------------------------------
Phenol, 4-(1,1-dimethylpropyl)- 80-46-6 When ready for use,
the end-use
concentration is not
to exceed 80 ppm
------------------------------------------------------------------------
Phosphonic acid, (1- 2809-21-4 When ready for use,
hydroxyethylidene)bis- the end-use
concentration is not
to exceed 34 ppm
------------------------------------------------------------------------
Phosphoric acid 7664-38-2 None
------------------------------------------------------------------------
Phosphoric acid, monosodium 7558-80-7 When ready for use,
salt the end-use
concentration is not
to exceed 350 ppm
------------------------------------------------------------------------
Phosphoric acid, trisodium 7601-54-9 When ready for use,
salt the end-use
concentration is not
to exceed 5916 ppm
in the formulated
product
------------------------------------------------------------------------
Poly(oxy-1,2-ethanediyl), None None
[alpha]-[(1,1,3,3-
tetramethylbutyl) phenyl]-w
-hydroxy-,
produced with one mole of the
phenol and 4 to 14 moles
ethylene oxide
------------------------------------------------------------------------
Potassium bromide 7758-02-3 When ready for use,
the end-use
concentration is not
to exceed 200 ppm
total available
halogen
------------------------------------------------------------------------
Potassium iodide 7681-11-0 When ready for use,
the end-use
concentration is not
to exceed 25 ppm of
titratable iodine
------------------------------------------------------------------------
Potassium permanganate 7722-64-7 When ready for use,
the end-use
concentration is not
to exceed 0.7 ppm
------------------------------------------------------------------------
[[Page 37792]]
Propanoic acid 79-09-4 When ready for use,
the end-use
concentration is not
to exceed 297 ppm
------------------------------------------------------------------------
2-Propanol (isopropanol) 67-63-0 None
------------------------------------------------------------------------
2,6-Pyridinedicarboxylic acid 499-83-2 When ready for use,
the end-use
concentration is not
to exceed 1.2 ppm
------------------------------------------------------------------------
Quaternary ammonium compounds, 8001-54-5 When ready for use,
alkyl (C12-C18) benzyl the end-use
dimethyl, chlorides concentration is not
to exceed 200 ppm of
active quaternary
compound
------------------------------------------------------------------------
Quaternary ammonium compounds, None When ready for use,
n-alkyl (C12-C14) dimethyl the end-use
ethylbenzyl ammonium concentration is not
chloride, average molecular to exceed 200 ppm of
weight (in amu), 377 to 384 active quaternary
compound
------------------------------------------------------------------------
Quaternary ammonium compounds, None When ready for use,
n-alkyl (C12-C18) dimethyl the end-use
ethylbenzyl ammonium chloride concentration is not
average molecular weight (in to exceed 200 ppm of
amu) 384 active quaternary
compound
------------------------------------------------------------------------
Quaternary ammonium compounds, None When ready for use,
di-n-Alkyl (C8-C10) dimethyl the end-use
ammonium chloride, average concentration is not
molecular weight (in amu), to exceed 240 ppm of
332 to 361 active quaternary
compound
------------------------------------------------------------------------
Sodium-[alpha]-alkyl(C12-C15)- None None
w-hydroxypoly
(oxyethylene) sulfate with
the poly(oxyethylene) content
averaging one mole
------------------------------------------------------------------------
Sodium bicarbonate 144-55-8 When ready for use,
the end-use
concentration is not
to exceed 120 ppm
------------------------------------------------------------------------
Sodium bromide 7647-15-6 When ready for use,
the end-use
concentration is not
to exceed 200 ppm
total available
halogen
------------------------------------------------------------------------
Sodium iodide 7681-82-5 When ready for use,
the end-use
concentration is not
to exceed 25 ppm of
titratable iodine
------------------------------------------------------------------------
Sodium mono-and None When ready for use,
didodecylphenoxy- the end-use
benzenedisulfonate concentration is not
to exceed 1,920 ppm
------------------------------------------------------------------------
Starch 9005-25-8 When ready for use,
the end-use
concentration is not
to exceed 16 ppm
------------------------------------------------------------------------
Sulfuric acid 7664-93-9 When ready for use,
the end-use
concentration is not
to exceed 228 ppm
------------------------------------------------------------------------
Sulfuric acid monododecyl 151-21-3 None
ester, sodium salt (sodium
lauryl sulfate)
------------------------------------------------------------------------
1,3,5-Triazine-2,4,6(1H,3H,5H)- 2782-57-2 When ready for use,
trione, 1,3-dichloro- the end-use
concentration is not
to exceed 100 ppm
determined as total
available chlorine
------------------------------------------------------------------------
1,3,5-Triazine-2,4,6(1H,3H,5H)- 2244-21-5 When ready for use,
trione, 1,3-dichloro-, the end-use
potassium salt concentration is not
to exceed 100 ppm
determined as total
available chlorine
------------------------------------------------------------------------
1,3,5-Triazine-2,4,6(1H,3H,5H)- 2893-78-9 When ready for use,
trione, 1,3-dichloro-, sodium the end-use
salt concentration is not
to exceed 100 ppm
determined as total
available chlorine
------------------------------------------------------------------------
1,3,5-Triazine-2,4,6(1H,3H,5H)- 87-90-1 When ready for use,
trione, 1,3,5-trichloro- the end-use
concentration is not
to exceed 100 ppm
determined as total
available chlorine
------------------------------------------------------------------------
1,3,5-Triazine, N,N',N''- 7673-09-8 When ready for use,
trichloro-2,4,6-triamino- the end-use
concentration is not
to exceed 200 ppm as
total available
chlorine
------------------------------------------------------------------------
Xylenesulfonic acid, sodium 1300-72-7 When ready for use,
salt the end-use
concentration is not
to exceed 62 ppm
------------------------------------------------------------------------
[FR Doc. 03-16034 Filed 6-24-03; 8:45 am]
BILLING CODE 6560-50-S