[Federal Register Volume 67, Number 232 (Tuesday, December 3, 2002)]
[Rules and Regulations]
[Pages 71847-71861]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30473]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-2002-0278; FRL-6824-2]


Pesticides; Tolerance Exemptions for Active and Inert Ingredients 
for Use in Antimicrobial Formulations (Food-Contact Surface Sanitizing 
Solutions)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: EPA is taking direct final action 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

[[Page 71848]]

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 direct 
final 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: This direct final rule is effective on April 2, 2003 without 
further notice, unless EPA receives a relevant adverse comment by 
February 3, 2003. If, however, EPA receives a relevant adverse comment 
during the comment period, then EPA will publish a timely withdrawal in 
the Federal Register informing the public that the direct final rule 
will not take effect. We will also publish a notice of proposed 
rulemaking in a future issue of the Federal Register. We will address 
the comments on the direct final rule as part of that notice of 
proposed rulemaking.
    Registrants should submit 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 on or before 
June 2, 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. Identification of a chemical substance is not a comment 
and should be identified as ``Submission of Non-designated Prior 
Approved Chemical 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: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are a food 
manufacturer, or antimicrobial pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                         Examples of
           Categories                NAICS codes         potentially
                                                      affected entities
------------------------------------------------------------------------
Industry                         311                 Food manufacturing
Producers                        32561               Antimicrobial
                                                      pesticides
------------------------------------------------------------------------


    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-2002-0278. 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.epa.gov/edocket/ 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

[[Page 71849]]

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 follow the online instructions for submitting comments. 
Once in the system, select ``search,'' and then key in docket ID number 
OPP-2002-0278. 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 [email protected], 
Attention: Docket ID Number OPP-2002-0278. 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-2002-0278.
    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-2002-0278. 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 copies of 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 the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the rule or collection 
activity.
    7. Make sure to submit your comments by the deadline in this 
document.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
ID number assigned to this action in the subject line on the first page 
of your response. You may also provide the name, date, and Federal 
Register citation.

[[Page 71850]]

II. Authority

A. What is the Agency's Authority for Taking this Action?

    This direct final 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 amedments 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 chemicals are now subject to modification or revocation 
at EPA's initiative under FFDCA section 408(e). This direct final rule 
duplicates those chemical substances found in 21 CFR 178.1010 which are 
now pesticide tolerance exemptions to 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.

B. Why is EPA Issuing this as a Direct Final Rule?

    EPA is issuing this action as a direct final rule without prior 
proposal because the Agency believes that this action is not 
controversial and is not likely to result in any adverse comments, 
inasmuch as this action simply implements amendments to the statutory 
authority and reflects the statutory transfer of jurisdiction from FDA 
to EPA. Its primary effect is to substitute EPA's regulatory procedures 
for those of FDA in approving food-contact surface sanitizing solutions 
under FFDCA. The chemical substances were subject to FDA review under 
FFDCA section 409 and have food additive clearances codified at 21 CFR 
178.1010. This direct final rule duplicates the conditions for use of 
certain pesticide chemical residues that are currently listed in 21 CFR 
178.1010 to 40 CFR 180.940. In addition, this direct final rule changes 
the process by which pesticide registrants obtain approval of food-
contact surface sanitizing solutions as well as how those approvals are 
expressed in the CFR. However, it does not alter the quantity or nature 
of residues of these food-contact surface sanitizing solutions that 
might lawfully be present in food. The Agency believes that it is 
important to make this action effective as soon as possible, in order 
to clarify the jurisdiction between EPA and FDA over these chemical 
substances.
    This direct final rule is effective on April 2, 2003 without 
further notice, unless EPA receives a relevant adverse comment by 
February 3, 2003. If, however, EPA receives a relevant adverse comment 
during the comment period, then EPA will publish a timely withdrawal in 
the Federal Register informing the public that the direct final rule 
will not take effect. We will also publish a notice of proposed 
rulemaking in a future issue of the Federal Register. We will address 
the comments on the direct final rule as part of that notice of 
proposed rulemaking.

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 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 direct final rule 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.

[[Page 71851]]

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 solutions are 
described in 21 CFR 178.1010:
    [sbull]Those used on food-contact surfaces in public eating places.
    [sbull]Those used on dairy-processing equipment.
    [sbull]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. 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

[[Page 71852]]

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 directly 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 June 2, 2003 
may be eligible for inclusion in Sec.  180.940 under FFDCA section 
408(j)(2). EPA anticipates publishing a notice of proposed rulemaking 
identifying those chemical substances shortly after that date.

V. Regulatory Assessment Requirements

    EPA is taking direct final action to 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 direct final 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), 
Executive Order 13045, entitled Protection of Children from 
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 
1997), or Executive Order 13211, entitled Actions Concerning 
Regulations That Significantly Affect Energy Supply, Distribution, or 
Use (66 FR 28355, May 22, 2001).
    This direct final rule directly regulates food processors, food 
handlers, and food retailers, but does not affect States, local, or 
Tribal governments directly. This action does not alter the 
relationships or distribution of power and responsibilities established 
by Congress in the preemption provisions of FFDCA section 408(n)(4). 
This action does not have substantial direct effects on State or tribal 
governments, on the relationship between the Federal government and 
States or Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and States or Indian 
tribes. As a result, this action does not require any action under 
Executive Order 13132, entitled Federalism (64 FR 43255, August 10, 
1999), or under Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Nor does it 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 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 Executive Order 12630, entitled Governmental Actions and 
Interference with Constitutionally Protected Property Rights (53 FR 
8859, March 15, 1988).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards under 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).
    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 Sec.  180.940 does not have significant negative economic impact on 
a substantial number of small entities. The rationale supporting this 
conclusion is as follows. This direct final 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 direct final rule is 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 direct 
final rule provides 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 direct final 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

[[Page 71853]]

Unit VII. 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 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, 
Environmental Protection Agency (2822), 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. 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.

VI. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this final rule in the Federal Register. This final 
rule is not a ``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Pesticides and pests, Reporting and 
recordkeeping requirements.


    Dated: November 22, 2002.
James Jones,
Acting Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is 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 
semipermanent 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)-[
 <]-hydroxypoly(oxyethylene)
 poly (oxypropylene) average
 molecular weight (in amu),
 768 to 837
------------------------------------------------------------------------
[alpha]-Alkyl(C12-C18)-[
 <]-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
------------------------------------------------------------------------
D&C Blue No.1 (methylene blue)  61-73-4            When ready for use,
                                                    the end-use
                                                    concentration is not
                                                    to exceed 0.4 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
------------------------------------------------------------------------

[[Page 71854]]

 
[alpha]-(p-Nonylphenyl)-        None               None
 [<
 g]-
 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
------------------------------------------------------------------------
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,  None               When ready for use,
 alkyl (C12-C16)                                    the end-use
 benzyldimethyl, chlorides,                         concentration is not
 average molecular weight (in                       to exceed 150 ppm of
 amu), 351 to 380                                   active quaternary
                                                    compound
------------------------------------------------------------------------
Quaternary ammonium compounds,  None               When ready for use,
 alkyl (C12-C18)                                    the end-use
 benzyldimethyl, chlorides                          concentration is not
                                                    to exceed 200 ppm of
                                                    active quaternary
                                                    compound in the
                                                    formulated product
------------------------------------------------------------------------
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.


[[Page 71855]]



------------------------------------------------------------------------
      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
------------------------------------------------------------------------
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 (Tartrazine)  1934-21-0          None
 (conforming 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-[
 <]-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
------------------------------------------------------------------------

[[Page 71856]]

 
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
------------------------------------------------------------------------
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)-[
 <]-hydroxypoly(oxyethylene)
 poly (oxypropylene) average
 molecular weight (in amu),
 768 to 837
------------------------------------------------------------------------
[alpha]-Alkyl(C11-C15)-[
 <]-hydroxypoly(oxyethylene)
 with ethylene oxide content 9
 to 13 moles
------------------------------------------------------------------------
[alpha]-Alkyl(C12-C15)-[
 <]-hydroxypoly (oxyethylene)
 polyoxypropylene, average
 molecular weight (in amu),
 965
------------------------------------------------------------------------

[[Page 71857]]

 
[alpha]-Alkyl(C12-C18)-[
 <]-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
------------------------------------------------------------------------
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-
------------------------------------------------------------------------
D&C Blue No.1 (methylene blue)  61-73-4            When ready for use,
                                                    the end-use
                                                    concentration is not
                                                    to exceed 0.4 ppm
------------------------------------------------------------------------
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
------------------------------------------------------------------------

[[Page 71858]]

 
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 (Tartrazine)  1934-21-0          None
 (conforming 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
------------------------------------------------------------------------
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-[
 <]-hydroxypoly (oxyethylene)
 with an average of 8-9 moles
 ethylene oxide, average
 molecular weight (in amu),
 400
------------------------------------------------------------------------
Magnesium oxide                 1309-48-4          None
------------------------------------------------------------------------
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)-        None               None
 [<
 g]-
 hydroxypoly(oxyethylene)
 maximum average molecular
 weight (in amu), 748
------------------------------------------------------------------------
[alpha]-(p-Nonylphenol)-        None               None
 [<
 g]-
 hydroxypoly(oxyethylene)
 average poly(oxyethylene)
 content 11 moles
------------------------------------------------------------------------
[alpha]-(p-Nonylphenyl)-        None               None
 [<
 g]-
 hydroxypoly(oxyethylene)
 produced by the condensation
 of 1 mole p-nonylphenol with
 9 to12 moles ethylene oxide
------------------------------------------------------------------------

[[Page 71859]]

 
[alpha]-(p-Nonylphenyl)-        None               None
 [<
 g]-
 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
------------------------------------------------------------------------
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
------------------------------------------------------------------------

[[Page 71860]]

 
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]-
 [<
 g]-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
------------------------------------------------------------------------
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-C16)                                    the end-use
 benzyldimethyl, chlorides,                         concentration is not
                                                    to exceed 200 ppm of
                                                    active quaternary
                                                    compound
------------------------------------------------------------------------
Quaternary ammonium compounds,  8001-54-5          When ready for use,
 alkyl (C12-C18)                                    the end-use
 benzyldimethyl, 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
 [<
 g]-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)
------------------------------------------------------------------------

[[Page 71861]]

 
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. 02-30473 Filed 12-2-02; 8:45 am]
BILLING CODE 6560-50-S