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April 28, 2004. Pesticides; Tolerance Exemptions for Active and Inert Ingredients for Use in Antimicrobial Formulations (Food-Contact Surface Sanitizing Solutions).
FINAL RULE. Federal Register. 


Note from FAN: There were hundreds of chemicals and subtances included in this Notice.
We have only listed the inorganic fluorine pesticides.
The following is our recap of these pesticides. The Notice then follows.

• 9. Section 180.910 is added to subpart D to read as follows:
Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance.
Residues of the following materials are exempted from the
requirement of a tolerance when used in accordance with good
agricultural practice as inert (or occasionally active) ingredients in
pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest:
Inert ingredients
- Click on for Index Page
Molecular Formula Limits Uses CAS No.
Dichlorodifluoromethane None listed Propellant 75-71-8
Dichlorotetrafluoroethane None listed Propellant 76-14-2
1,1-Difluoroethane None listed Aerosol propellant. For aerosol pesticide formulations used for insect control in food- and feed-
handling establishments and animals.
75-37-6
Montmorillonite-type clay treated with polytetrafluoroethylene (PTFE; CAS Reg. No. 9002-84-0). PTFE:
PTFE content not greater than 0.5% of clay (w/w). Carrier. 9002-84-0
1,1,1,2-Tetrafluoroethane None listed Aerosol propellant 811-97-2
Trichlorofluoromethane None listed Propellant 75-69-4

• 10. Section 180.920 is added to subpart D to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
The following materials are exempted from the requirement of a
tolerance when used in accordance with good agricultural practice as
inert (or occasionally active) ingredients in pesticide formulations
applied to growing crops only:
Inert ingredients
- Click on for Index Page
Molecular Formula Limits Uses CAS No.
Fluoroapatite This is a mineral.
Structure not available
None listed Solid diluent, carrier 1306-05-4
Mono- and bis-(1H, 1H, 2H, 2H-
perfluoroalkyl) phosphates where the alkyl group is even numbered and in the C6- C12 range.
No CAS No.
or structure
available
Not more than 0.5% of pesticide formulation. Defoaming agent None
Sodium fluoride Not more than 0.25% of pesticide formulation Stabilizer carrier for formulations used before crop emerges from soil 7681-49-4

• 11. Section 180.930 is added to subpart D to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
The following materials are exempted from the requirement of a
tolerance when used in accordance with good agricultural practice as
inert (or occasionally active) ingredients in pesticide formulations
applied to animals:
Inert ingredients
- Click on for Index Page
Molecular Formula Limits Uses CAS No.
Dichlorodifluoromethane None listed Propellant 75-71-8
1,1-Difluoroethane None listed Aerosol propellant. For aerosol pesticide formulations used for insect control in food- and feed-handling establishments and animals. 75-37-6
2-[Methyl [(perfluoroalkyl)alkyl(C2-C8)
sulfonyl]amino]alkyl(C2-C8) acrylate--
alkyl(C2-C8)
methacrylates-N-methylolacrylamide
copolymer
No CAS No.
or structure
available
None listed Water repellant agent None
Trichlorofluoromethane None listed Propellant 75-69-4


http://www.epa.gov/fedrgstr/EPA-PEST/2004/April/Day-28/p9578.htm

[Federal Register: April 28, 2004 (Volume 69, Number 82)]
[Rules and Regulations]
[Page 23113-23142]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap04-11]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 153, 168, and 180
[OPP-2003-0368; FRL-7335-4]

Pesticides; Tolerance Exemptions for Active and Inert Ingredients
for Use in Antimicrobial Formulations (Food-Contact Surface Sanitizing
Solutions)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is adding a new section to part 180 to list the pesticide
chemicals that are exempt from the requirement of a tolerance when used
in food-contact surface sanitizing solutions. This list of exempt
pesticide chemicals is duplicated from the Food and Drug
Administration's (FDA) regulations in 21 CFR 178.1010. For some of
these chemical substances, EPA's list will use naming conventions
differing from those used by FDA. Additionally, EPA is redesignating/
reorganizing Sec. 180.1001. This section of CFR will be split into
five separate sections with no changes in text or content.

DATES: This final rule is effective on April 28, 2004.
ADDRESSES: EPA has established a docket for this action under Docket ID
number OPP-2003-0368 All documents in the docket are listed in the
EDOCKET index at http://www.epa.gov/edocket. Although listed in the
index, some information is not publicly available, i.e., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either electronically in
EDOCKET or in hard copy at the Public Information and Records Integrity
Branch (PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis
Hwy., Arlington, VA., Monday through Friday, excluding legal holidays.
The Docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-6304; fax number: (703) 305-0599; e-mail address:
boyle.kathryn@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does This Action Apply to Me?
You may be potentially affected by this action if you formulate or
market pesticide products. Potentially affected categories and entities
may include, but are not limited to:
• Food manufacturing (NAICS 311)
• Antimicrobial pesticides (NAICS 32561)
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.
B. How Can I Access Copies Of this Document and Other Related
Information?
In addition to using EDOCKET (http://www.epa.gov/edocket/, 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 E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.II. What is the Agency's Authority for Taking this Action?
This final rule is issued under the Federal Food, Drug and Cosmetic
Act (FFDCA) section 408, 21 U.S.C. 346a, as amended by the Food Quality
Protection Act (FQPA) (Public Law 104-170), and the Antimicrobial
Regulation Technical Correction Act (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.
Owing to the FQPA and ARTCA amendments to FFDCA, certain chemical
substances originally regulated by FDA under FFDCA section 409 as food-
contact surface sanitizing solutions are now subject to EPA's authority
under FFDCA section 408. 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.
These pesticide chemical regulations are now subject to
modification or revocation at EPA's initiative under FFDCA section
408(e). Today's rule duplicates the substance of FDA's food additive
regulations for those chemical substances found in 21 CFR 178.1010
which are now pesticide chemicals,
by codifying tolerance exemptions in
a format consistent with EPA's authority under section 408 in a new
section, 40 CFR 180.940.
Because some solutions described in 21 CFR 178.1010 may still have
uses as food additives, FDA is leaving 21 CFR 178.1010 in effect. EPA's
rulemaking activity has no effect on any of the FDA-regulated FFDCA
section 409 food additive regulations in 21 CFR 178.1010.
III. Impact on Tolerance Reassessment
This rule shifts existing tolerance exemptions from 21 CFR 178.1010
to 40 CFR 180.940.
These are duplicated from existing, 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. 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 by FFDCA section 408(j)(2)
into FFDCA section 408 tolerance exemptions. Thus, EPA's duplication of
these tolerance exemptions is not ``establishing, modifying, or
revoking a tolerance'' under FFDCA section 408(b). EPA is not,
therefore, required to conduct a full reassessment of these tolerance
exemptions at this time. However, because the tolerance exemptions
duplicated from 21 CFR 178.1010 into 40 CFR 180.940 were in effect
prior to the enactment of FQPA, they are subject to the tolerance
reassessment deadline of August 2, 2006.
IV. Background
In the Federal Register of December 3, 2002 (67 FR 71847) (FRL-
6824-2), the Agency published a direct final rule to establish 40 CFR
180.940. Comments were received. In the December 3, 2002 FR final rule,
EPA had announced that it would withdraw the direct final rule if it
received adverse comment, and proceed with proposed rule as provided by
section 553 of the Administrative
[[Page 23114]]
Procedure Act, 5 U.S.C. 553. Because some of the comments were of a
nature that would warrant a response if made on a proposed rule, they
were adverse comments that required withdrawal of the direct final
rule. EPA withdrew the direct final rule
on March 24, 2003 (68 FR
14165)(FRL-7299-4).
In the Federal Register of June 25, 2003 (68 FR 37778) (FRL-7302-
2), the Agency issued its proposal to establish 40 CFR 180.940. The
comments received as a result of the December 3, 2002, direct final
rule were addressed in that proposed rule.
Six comments were received in response to the June 25\th\ proposed
rule. There was also a late comment to the direct final rule.
One commenter requested to increase the concentrations of certain
chemical ingredients. At this time, EPA is not proposing to change the
upper concentration limits as specified by FDA in 21 CFR 178.1010. The
purpose of this final rule action is to duplicate FDA's previous
clearances in a format consistent with EPA's authority under section
408.
To increase the concentration limitations from those specified by
FDA, requires the performance of a risk assessment. At this time EPA is
merely duplicating the listing of chemicals in 21 CFR 178.1010 to 40
CFR 180.940, albeit in a different format. EPA is required under
section 408(q)(1)(C) to complete tolerance reassessment for all
pesticide chemicals by 2006
, and will consider the commenter's
suggestion during tolerance reassessment.
The same commenter requested that all GRAS ingredients listed under
21 CFR part 184 be included in 180.940. Another commenter requested
that all chemical substances designated as GRAS in 21 CFR part 582 be
included in 40 CFR 180.940 under a catch-all provision. The Agency
understands that 21 CFR 178.1010 allows the inclusion of GRAS chemical
substances and chemical substances ``permitted by prior sanction or
approval,'' that are not expressly identified in 21 CFR 178.1010. It is
for this reason that the Agency asked registrants of food-contact
surface sanitizing solutions to specifically identify all other
ingredients that they believe should be included in 40 CFR 180.940. At
a later date, EPA intends to publish its proposal to revise 40 CFR
180.940 by adding chemical substances that were not specified by name
in 21 CFR 178.1010 but that are included in a registered food-contact
surface sanitizing solution. Today's final rule only considers the
chemical substances that were specified by name in 21 CFR 178.1010.
One commenter expressed concern that documenting all of FDA's
informal clearances could prove to be difficult. They stated that the
existence of a registration should be sufficient proof. The Agency
agrees. In fact, several registrants of various food-contact surface
sanitizing solutions have already supplied the Agency with a list of
chemical substances that were not included in the proposed 40 CFR
180.940, but are part of a registered pesticide product. The claims for
inclusion of these chemical substances were documented only by
reference to an EPA Registration Number. Where EPA's files clearly
demonstrate both that the registered pesticide was subject to section
409 and contained the chemical substance before enactment of the FQPA,
EPA will include the chemical substance in the upcoming proposal to
revise 40 CFR 180.940. So although identifying a registered pesticide
as containing a particular chemical substance may be sufficient to
support inclusion in 40 CFR 180.940, registrants can maximize the
likelihood of inclusion by providing documentation of FDA's prior
sanction or approval.
Two commenters requested confirmation on whether or not chemical
substances that are included in an existing, registered food-contact
surface sanitizing solution, but are not included by name in 21 CFR
178.1010, are considered under this final rule to be FDA-approved
substances. Today's final rule does not address such chemical
substances. In the preambles to both the direct final rule and the
proposed rule, EPA asked registrants of food-contact surface sanitizing
solutions to identify to EPA any chemical substances that they claim
have been cleared by FDA for use in sanitizing solutions but not
expressly identified in 21 CFR 178.1010. As previously stated, at some
time in the near future, EPA intends to publish its proposal to revise
40 CFR 180.940 to add chemical substances that were not specified by
name in 21 CFR 178.1010. In order to preserve the use of registered
food-contact surface sanitizing solutions whose ingredients were
cleared by FDA before FQPA's enactment, EPA will treat all of the
component chemicals (whether or not they are specifically identified in
21 CFR 178.1010) of registered food-contact surface sanitizing
solutions as exempt from the requirement of a tolerance until EPA has
completed its review of the registrants' claims with respect to
pesticide chemicals not specifically identified in 21 CFR 178.1010.
The same two commenters also stated that EPA should not distinguish
between the three categories of food-contact surface sanitizing
solutions. They believe that these categories have not been rigidly
applied. Today's final rule addresses only those use patterns as
specifically described in 21 CFR 178.1010. If a registrant supplies
information to the Agency to demonstrate that FDA cleared a solution
for uses broader than described in Sec. 178.1010, then EPA can include
these changes in its upcoming proposal to revise 40 CFR 180.940.
However, today's regulation merely duplicates the substance of the
existing FDA regulation.
The late comment (to the direct final rule) requested that all of
the quaternary sanitizer solutions currently listed under 21 CFR
178.1010 be approved by EPA for end use at a concentration not to
exceed 400 ppm of the active quaternary compound. The rationale for
such a change included a statement that FDA had intended to make such a
change and a discussion of the concerns of public health officials who
advocate for solutions with demonstrated efficacy over a wide range of
concentrations. Such a range would provide the user ``a reasonable
margin of error'' while preparing safe and effective sanitizing solutions.
In a similar manner, another commenter indicated its belief that
the proposed language for the quaternary ammonium compounds was
inconsistent with the existing FDA regulations. According to the
commenter FDA had established a total limit of 400 ppm for the
quaternary ammonium compounds, while EPA's approach could possibly
allow up to 750 ppm. EPA discussed this issue with FDA, and concluded
that the comments have merit, not only for the quaternary ammonium
compounds, but also for other chemicals that were expressed as total or
solution limits. This would include the halogens (chloride-, bromide-,
and iodide-producing chemicals) and napthalene sulfonate derivatives.
Since the concentration limits for the above chemicals are specified in
21 CFR 178.1010 as total or solution limits, this change has been
carried forward to 40 CFR 180.940.
One of the commenters submitted a letter from FDA which seemed to
indicate that FDA had raised the maximum at-use concentration of
certain chemicals from 200 ppm to 220 ppm. This comment was also
discussed with FDA who indicated that while they had ``no objection''
to 220 ppm as the at-use concentration, they intended that the
tolerance for residues in or on food should remain at 200 ppm. FDA
would continue to have no objection to use
[[Page 23115]]
levels as high as 220 as indicated through field testing.
While not in response to a comment, the Agency is making several
changes to the list of chemical substances proposed in the June 25\th\
proposed rule. Several of the chemical substances (citric acid,
dextrin, magnesium oxide, sodium bicarbonate, starch and octadecanoic
acid, calcium salt) have been recently classified as List 4A minimal
risk inert ingredients (see the listings of inert ingredients at
http://www.epa.gov/opprd001/inerts/lists.html). Tolerance exemptions for
certain of these List 4A substances (citric acid, dextrins, and starch
(as a food commodity)) have already been established in 40 CFR 180.950,
the section of CFR that holds ``Tolerance Exemptions for Minimal Risk
Active and Inert Ingredients.'' Because chemical substances with a
tolerance exemption identified in 40 CFR 180.950 may be used in any
pesticide product, including antimicrobial products, without
limitation, having tolerance exemptions in both 40 CFR 180.940 and
180.950 would be redundant. Therefore, duplicative entries for citric
acid, dextrin, and starch are not created today in 40 CFR 180.940.
Additionally, because the Agency intends that all List 4A substances
eventually will be transferred to 40 CFR 180.950 without limitations,
the Agency is removing the concentration use limitations for sodium
bicarbonate, magnesium oxide and octadecanoic acid, calcium salt.
Based on the reasons set forth in the preamble to the proposed
rule, and considering the comments received by the Agency in response
to the direct final and proposed rules, EPA is creating a new section
40 CFR 180.940.
Redesignation of 40 CFR 180.1001
In the July 1, 2002 edition of title 40 CFR parts 150 to 189, Sec.
180.1001 occupies pages 508 to 537, a large amount of information for
one section of CFR. Today's action shifts and splits 40 CFR 180.1001
with no changes to the text or content. See Table 1 for a redesignation
of the paragraphs and the new sections.
Table 1.--Redesignation of 40 CFR 180.1001
------------------------------------------------------------------------
Former CFR Designation New CFR Designation
------------------------------------------------------------------------
180.1001(a) 40 CFR 180.900
------------------------------------------------------------------------
180.1001(b) 40 CFR 180.905
------------------------------------------------------------------------
180.1001(c) 40 CFR 180.910
------------------------------------------------------------------------
180.1001(d) 40 CFR 180.920
------------------------------------------------------------------------
180.1001(e) 40 CFR 180.930
------------------------------------------------------------------------
All references to 40 CFR 180.1001 in other sections of 40 CFR are
also being changed to reflect the shift. Additionally two FDA
regulations cite to 180.1001: 21 CFR 182.99 and 582.99. FDA is aware
that this shift of 40 CFR 180.1001 is occurring.
V. Objections and Hearing Requests
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.
A. What Do I Need to Do to File an Objection or Request a Hearing?
You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket ID number OPP-2003-0368 in the subject line on the
first page of your submission. All requests must be in writing, and
must be mailed or delivered to the Hearing Clerk on or before June 28,
2004.

1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900C),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001. You may also deliver your request to the
Office of the Hearing Clerk in Rm.104, Crystal Mall #2, 1921
Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is
open from 8 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Office of the Hearing Clerk is
(703) 603-0061.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit V.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in ADDRESSES. Mail your
copies, identified by docket ID number OPP-2003-0368, to: Public
Information
[[Page 23116]]
and Records Integrity Branch, Information Resources and Services
Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in ADDRESSES. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 or ASCII file format.
Do not include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.
B. When Will the Agency Grant a Request for a Hearing?
A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).
VI. Statutory and Executive Order Reviews
This final rule reorganizes the existing exemptions in 40 CFR
180.1001, shifting them from one section to another within the same
part. The Agency is acting on its own initiative under FFDCA section
408(e) in shifting these existing tolerance exemptions to a new section
of part 180. This has no substantive effect, and is not expected to
have any adverse impact, or otherwise impose any new requirements.
This final rule also establishes a new section, 40 CFR 180.940,
``Tolerance Exemptions for Active and Inert Ingredients for Use in
Antimicrobial Formulations (Food-Contact Surface Sanitizing
Solutions).'' As discussed in Unit II., this new section merely
duplicates that portion of the existing FDA regulation 21 CFR 178.1010
that applies to chemical substances that are now subject to EPA's
authority under FFDCA section 408.

The Office of Management and Budget (OMB) has exempted these types
of actions from review under Executive Order 12866, entitled Regulatory
Planning and Review (58 FR 51735, October 4, 1993). Because this rule
has been exempted from review under Executive Order 12866 due to its
lack of significance, this rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This final
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). Nor does it require any special
considerations under Executive Order 12898, entitled Federal Actions to
Address Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). This action does not involve any technical standards
that would require Agency consideration of voluntary consensus
standards pursuant to section 12(d) of the National Technology Transfer
and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d)
(15 U.S.C. 272 note).
Under section 605(b) of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.), the Agency hereby certifies that the proposed
action to reorganize 40 CFR 180.1001 will not have significant negative
economic impact on a substantial number of small entities. Creation of
a new section and the reorganization of 40 CFR 180.1001 does not have a
substantive effect and hence causes no impact. In addition, the Agency
has determined that this action will not have a substantial direct
effect on States, on the relationship between the national government
and the States, or on the distribution of power and responsibilities
among the various levels of government, as specified in Executive Order
13132, entitled Federalism(64 FR 43255, August 10, 1999). Executive
Order 13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This final
rule directly regulates growers, food processors, food handlers and
food retailers, not States. This action does not alter the
relationships or distribution of power and responsibilities established
by Congress in the preemption provisions of FFDCA section 408(n)(4).
For these same reasons, the Agency has determined that this rule does
not have any ``tribal implications'' as described in Executive Order
13175, entitled Consultation and Coordination with Indian Tribal
Governments (59 FR 22951, November 6, 2000). Executive Order 13175,
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by tribal officials in the development of regulatory
policies that have tribal implications.'' ``Policies that have tribal
implications'' is defined in the Executive order to include regulations
that have ``substantial direct effects on one or more Indian tribes, on
the relationship between the Federal Government and the Indian tribes,
or on the distribution of power and responsibilities between the
Federal Government and Indian tribes.'' This rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this rule.
VII. Congressional Review Act
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 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 the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Parts 153, 168, and 180
Environmental protection, Administrative practice and procedure,
Advertising, Agricultual commodities,
[[Page 23117]]
Exports, Labeling, Pesticides and pests, Reporting and recordkeeping
requirements.
Dated: April 21, 2004.
James Jones,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 153--[AMENDED]
• 1. The authority citation for part 153 continues to read as follows:
Authority: 15 U.S.C. 136 et seq.
• 2. Sections 153.155 is amended by revising paragraph (c)(1) to read as
follows:
Sec. 153.155 Seed treatment products.
* * * * *
(c) * * *
(1) Sections 180.910, 180.920, and 180.950 if an exemption from the
requirement of a tolerance has been established.
* * * * *
PART 168--[AMENDED]
• 3. The authority citation for part 168 continues to read as follows:
Authority: 15 U.S.C. 136 et seq.
• 4. Section 168.65 is amended by revising the first sentence of
paragraph (b)(1)(iii)(A)(2)(i), and by revising paragraph
(b)(1)(iii)(A)(2)(ii) to read as follows:
Sec. 168.65 Pesticide export label and labeling requirements.
* * * * *
(b) * * *
(1) * * *
(iii) * * *
(A) * * *
(2) * * *
(i) The change in color must result only from the addition of a dye
included on the list of the chemicals exempted from the requirement of
a tolerance at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the
dye must not be a List 1 inert. * * *
(ii) The change in fragrance must result only from the addition of
a chemical included on the list of the chemicals exempted from the
requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and
180.950, and the chemical must not be a List 1 inert.
* * * * *
• 5. Section 168.75 is amended by revising the second and fifth sentences
of paragraph (b)(4)(iii) to read as follows:
Sec. 168.75 Procedures for exporting unregistered pesticide-purchase
acknowledgment statements.
* * * * *
(b) * * *
(4) * * *
(iii) * * * The change in color must result only from the addition
of a dye included on the list of the chemicals exempted from the
requirement of a tolerance at 40 CFR 180.910, 180.920, 180.930, and
180.950, and the dye must not be a List 1 inert. * * * The change in
fragrance must result only from the addition of a chemical included on
the list of the chemicals exempted from the requirement of a tolerance
at 40 CFR 180.910, 180.920, 180.930, and 180.950, and the chemical must
not be a List 1 inert. * * *
* * * * *
PART 180--[AMENDED]
• 6. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
• 7. Section 180.900 is added to subpart D to read as follows:
Sec. 180.900 Exemptions from the requirement of a tolerance.
An exemption from a tolerance shall be granted when it appears that
the total quantity of the pesticide chemical in or on all raw
agricultural commodities for which it is useful under conditions of use
currently prevailing or proposed will involve no hazard to the public
health.
• 8. Section 180.905 is added to subpart D to read as follows:
Sec. 180.905 Pesticide chemicals; exemptions from the requirement of
a tolerance.
(a) When applied to growing crops, in accordance with good
agricultural practice, the following pesticide chemicals are exempt
from the requirement of a tolerance:
(1) [Reserved]
(2) N-Octylbicyclo(2,2,1)-5-heptene-2,3-dicarboximide.
(3) Petroleum oils.
(4) Piperonyl butoxide.
(5) [Reserved]
(6) Pyrethrum and pyrethrins.
(7) Rotenone or derris or cube roots.
(8) Sabadilla.
(b) These pesticides are not exempted from the requirement of a
tolerance when applied to a crop at the time of or after harvest.
• 9. Section 180.910 is added to subpart D to read as follows:Sec. 180.910 Inert ingredients used pre- and post-harvest; exemptions from the requirement of a tolerance.
Residues of the following materials are exempted from the
requirement of a tolerance when used in accordance with good
agricultural practice as inert (or occasionally active) ingredients in
pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest:

------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------

[[Page 23118]]

[[Page 23119]]

Dichlorodifluoromethane...... ................ Propellant
Dichlorotetrafluoroethane.... ................ Do.

1,1-Difluoroethane (CAS Reg. No. 75-37-6). Aerosol propellant. For aerosol pesticide formulations used for insect control in food- and feed-handling establishments and animals.

[[Page 23120]]

Montmorillonite-type clay treated with polytetrafluoroethylene (PTFE; CAS Reg. No. 9002-84-0). Carrier.
PTFE content not greater than 0.5% of clay (w/w).


[[Page 23121]]

1,1,1,2-Tetrafluoroethane, ................ Aerosol propellant
(CAS Reg. No. 811-97-2).


Trichlorofluoromethane....... ................ Propellant

[[Page 23124]]

Wheat, including flour, bran, Expires May 24, 2005. Solid diluent carrier,
and starch. . attractant
Wheat bran................... ................ Do.

------------------------------------------------------------------------
• 10. Section 180.920 is added to subpart D to read as follows:
Sec. 180.920 Inert ingredients used pre-harvest; exemptions from the
requirement of a tolerance.
The following materials are exempted from the requirement of a
tolerance when used in accordance with good agricultural practice as
inert (or occasionally active) ingredients in pesticide formulations
applied to growing crops only:

------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------

[[Page 23125]]

[[Page 23127]]

Fluoroapatite................ ................ Solid diluent, carrier

Mono- and bis-(1H, 1H, 2H, 2H- Not more than Defoaming agent
perfluoroalkyl) phosphates 0.5% of where the alkyl group is pesticide
even numbered and in the C6- formulation.C12 range.


[[Page 23129]]

Sodium fluoride.............. Not more than 0.25% of pesticide formulation.
Stabilizer carrier for formulations used
before crop emerges from soil

[[Page 23130]]

------------------------------------------------------------------------
• 11. Section 180.930 is added to subpart D to read as follows:Sec. 180.930 Inert ingredients applied to animals; exemptions from the requirement of a tolerance.
The following materials are exempted from the requirement of a
tolerance when used in accordance with good agricultural practice as
inert (or occasionally active) ingredients in pesticide formulations
applied to animals:

[[Page 23131]]
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------

Dichlorodifluoromethane...... ................ Propellant

1,1-Difluoroethane (CAS Reg. For aerosol Aerosol propellant
No. 75-37-6). pesticide formulations used for insect
control in food- and feed-handling establishments and animals.


[[Page 23133]]

2-[Methyl [(perfluoroalkyl)alkyl(C2-C8) sulfonyl]amino]alkyl(C2-C8) acrylate--alkyl(C2-C8)
methacrylates-N-methylolacrylamide copolymer................. Water repellant agent


[[Page 23134]]

Trichlorofluoromethane....... ................ Propellant

Wheat shorts................. Expires May 24, 2005. Solid diluent.

[[Page 23136]]

------------------------------------------------------------------------0
12. Section 180.940 is added to subpart D to read as follows:Sec. 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing
solutions).
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 substance is applied on a semi-permanent
or permanent food-contact surface (other than being applied on food
packaging) with adequate draining before contact with food.
(a) The following chemical substances when used as ingredients in
an antimicrobial pesticide formulation may be applied to: Food-contact
surfaces in public eating places, dairy-processing equipment, and food-
processing equipment and utensils.

------------------------------------------------------------------------
Pesticide Chemical CAS Reg. No. Limits
------------------------------------------------------------------------
[[Page 23137]]

------------------------------------------------------------------------
(b) The following chemical substances when used as ingredients in
an antimicrobial pesticide formulation may be applied to: Dairy
processing equipment, and food-processing equipment and utensils.-
-----------------------------------------------------------------------
Pesticide Chemical CAS Reg. No. Limits
------------------------------------------------------------------------

------------------------------------------------------------------------
(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 Reg. No. Limits
------------------------------------------------------------------------

[[Page 23139]]


[[Page 23140]]


[[Page 23141]]

[[Page 23142]]

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Sec. 180.1001 [Removed]
• 13. Section 180.1001 is removed.
• 14. In Sec. 180.1067, paragraph (b) is revised to read as follows:
Sec. 180.1067 Methyl eugenol and malathion combination; exemption
from the requirement of a tolerance.
* * * * *
(b) This combination is to be impregnated on a carrier (cigarette
filter tips (cellulose acetate); cotton strings; fiberboard squares) or
mixed with a jel cleared under 40 CFR 180.920 or 180.950.
* * * * *
[FR Doc. 04-9578 Filed 4-27-04; 8:45 am]
BILLING CODE 6560-50-S