[Federal Register Volume 76, Number 115 (Wednesday, June 15, 2011)]
[Proposed Rules]
[Pages 34937-34945]
[FR Doc No: 2011-14827]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

 [EPA-HQ-OPP-2011-0369; FRL-8874-3]

Amitraz, Bentazon, Bifenthrin, Chlorfenapyr, Cyfluthrin,
Deltamethrin, et al.; Proposed Tolerance Actions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: In accordance with current Agency practice to describe more
clearly the measurement and scope or coverage of tolerances, EPA is
proposing minor revisions to tolerance expressions for a number of
pesticide active ingredients, including the insecticides amitraz,
bifenthrin, chlorfenapyr, cyfluthrin, deltamethrin, esfenvalerate,
fenpropathrin, and pyridaben; the fungicide metalaxyl; the herbicides
bentazon, quizalofop ethyl, sodium acifluorfen, and tebuthiuron; and
the plant growth regulator ethephon. Also, EPA proposes to remove
several expired tolerances for quizalofop ethyl.

DATES: Comments must be received on or before August 15, 2011.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2011-0369, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2011-0369. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. 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. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., 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 in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Joseph Nevola, Pesticide Re-evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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. To determine
whether you or your business may be affected by this action, you should
carefully examine the applicability provisions in Unit II.A. 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. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, 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 claimed as CBI. In addition to one
complete version of the comment that includes 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.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.

II. Background

A. What action is the agency taking?

    In accordance with current Agency practice to describe more clearly
the measurement and scope or coverage of tolerances, including
applicable metabolites and degradates, EPA is proposing minor revisions
to tolerance expressions for a number of pesticide active ingredients,
including the insecticides amitraz, bifenthrin, chlorfenapyr,
cyfluthrin, deltamethrin, esfenvalerate, fenpropathrin, and pyridaben;
the fungicide metalaxyl; the herbicides bentazon, quizalofop ethyl,
sodium acifluorfen, and tebuthiuron; and the plant growth regulator
ethephon. The revisions will not substantively change the tolerance or,
in any way, modify the permissible level of residues permitted by the
tolerance. Also, EPA proposes to remove several expired tolerances for
quizalofop ethyl.
    The amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA)
section 408 in the Food Quality Protection Act of 1996 clarified that a
tolerance regulation for a pesticide chemical applies to that chemical
as well as all metabolites and degradates of that chemical unless EPA
specifies otherwise (21 U.S.C. 346a(a)(3)(C)). These amendments also
specified how compliance with a tolerance level was to be determined
when a metabolite or degradate of a pesticide chemical not specifically
mentioned in the tolerance was found in a food (21 U.S.C.
346a(a)(3)(B)). In light of these changes, EPA now generally follows an
approach for drafting tolerance expressions that makes clear that the
tolerance applies not only to the parent chemical but also to its
metabolites and degradates and also specifies precisely what chemical
moieties are to be measured in determining compliance with the
tolerance levels included in the tolerance regulation. This approach
ensures that there is no confusion regarding what chemical moieties are
authorized in food by the tolerance or how compliance with the
tolerance levels is to be determined. Under this approach, tolerance
expressions would follow this general form:
    Tolerances are established for residues of the [ insecticide,
herbicide, fungicide, as appropriate] [pesticide chemical name],
including its metabolites and degradates, in or on the commodities in
the table in this paragraph. Compliance with the tolerance levels
specified in this paragraph is to be determined by measuring only [the
designated chemical moieties], in or on the commodity.
    This model has been followed for all of the pesticides named in
this unit, and the actual language is set out in the proposed
regulation text at the end of this document. The only additional
changes proposed in this action are with regard to the pesticides
bifenthrin, chlorfenapyr, cyfluthrin, and deltamethrin, and they are at
the end of this document.
    Certain time-limited tolerances pertaining to the pesticide
quizalofop ethyl in 40 CFR 180.441(a)(4) have expired, on June 14,
1999, due to previous EPA regulation setting expiration dates.
Therefore, the Agency is proposing to remove the expired time-limited
tolerances for quizalofop ethyl in 40 CFR 180.441(a)(4) on beet, sugar,
molasses; beet, sugar, roots; beet, sugar, tops; vegetable, foliage of
legume, except soybean, subgroup 7A; and vegetable, legume, group 6.
This rule only corrects the Code of Federal Regulations to conform with
the fact that the tolerances already expired, and therefore EPA is not
accepting comments regarding the expiration itself.

B. What is the agency's authority for taking this action?

    A ``tolerance'' represents the maximum level for residues of
pesticide chemicals legally allowed in or on raw agricultural
commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 346a,
as amended by FQPA of 1996, Public Law 104-170, authorizes the
establishment of tolerances, exemptions from tolerance requirements,
modifications in tolerances, and revocation of tolerances for residues
of pesticide chemicals in or on raw agricultural commodities and
processed foods. Without a tolerance or exemption, food containing
pesticide residues is considered to be unsafe and therefore
``adulterated'' under section 402(a) of FFDCA, 21 U.S.C. 342(a). Such
food may not be distributed in interstate commerce (21 U.S.C. 331(a)).
For a food-use pesticide to be sold and distributed, the pesticide must
not only have appropriate tolerances under the FFDCA, but also must be
registered under FIFRA (7 U.S.C. 136 et seq.). Food-use pesticides not
registered in the United States must have tolerances in order for
commodities treated with those pesticides to be imported into the
United States.
    EPA's general practice is to propose revocation of tolerances for
residues of pesticide active ingredients on crops for which FIFRA
registrations no longer exist and on which the pesticide may therefore
no longer be used in the United States. EPA has historically been
concerned that retention of tolerances that are not necessary to cover
residues in or on legally treated foods may encourage misuse of
pesticides within the United States. Nonetheless, EPA will establish
and maintain tolerances even when corresponding domestic uses are
canceled if the tolerances, which EPA refers to as ``import
tolerances,'' are necessary to allow importation into the United States
of food containing such pesticide residues. However, where

there are no imported commodities that require these import tolerances,
the Agency believes it is appropriate to revoke tolerances for
unregistered pesticides in order to prevent potential misuse.
    Furthermore, as a general matter, the Agency believes that
retention of import tolerances not needed to cover any imported food
may result in unnecessary restriction on trade of pesticides and foods.
Under section 408 of FFDCA, a tolerance may only be established or
maintained if EPA determines that the tolerance is safe based on a
number of factors, including an assessment of the aggregate exposure to
the pesticide and an assessment of the cumulative effects of such
pesticide and other substances that have a common mechanism of
toxicity. In doing so, EPA must consider potential contributions to
such exposure from all tolerances. If the cumulative risk is such that
the tolerances in aggregate are not safe, then every one of these
tolerances is potentially vulnerable to revocation. Furthermore, if
unneeded tolerances are included in the aggregate and cumulative risk
assessments, the estimated exposure to the pesticide would be inflated.
Consequently, it may be more difficult for others to obtain needed
tolerances or to register needed new uses. To avoid potential trade
restrictions, the Agency is proposing to revoke tolerances for residues
on crops uses for which FIFRA registrations no longer exist, unless
someone expresses a need for such tolerances. Through this proposed
rule, the Agency is inviting individuals who need these import
tolerances to identify themselves and the tolerances that are needed to
cover imported commodities.
    Parties interested in retention of the tolerances should be aware
that additional data may be needed to support retention. These parties
should be aware that, under FFDCA section 408(f), if the Agency
determines that additional information is reasonably required to
support the continuation of a tolerance, EPA may require that parties
interested in maintaining the tolerances provide the necessary
information. If the requisite information is not submitted, EPA may
issue an order revoking the tolerance at issue.

C. When do these actions become effective?

    EPA is proposing that revision of specific tolerance expressions
and removal of expired tolerances for quizalofop ethyl proposed herein
become effective on the date of publication of the final rule in the
Federal Register. If you have comments, please submit comments as
described under SUPPLEMENTARY INFORMATION.
    Any commodities listed in this proposal treated with the pesticides
subject to this proposal, and in the channels of trade following the
tolerance revocations, shall be subject to FFDCA section 408(1)(5), as
established by FQPA. Under this unit, any residues of these pesticides
in or on such food shall not render the food adulterated so long as it
is shown to the satisfaction of the Food and Drug Administration that:
    1. The residue is present as the result of an application or use of
the pesticide at a time and in a manner that was lawful under FIFRA,
and
    2. The residue does not exceed the level that was authorized at the
time of the application or use to be present on the food under a
tolerance or exemption from tolerance. Evidence to show that food was
lawfully treated may include records that verify the dates when the
pesticide was applied to such food.

III. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and
Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for chlorfenapyr, pyridaben,
quizalofop ethyl, sodium acifluorfen, and tebuthiuron.
    The Codex has established MRLs for amitraz in or on various
commodities including edible offal of pigs at 0.2 milligram/kilograms
(mg/kg). The MRL is different than the tolerance established for
amitraz in the United States because of differences in residue
definition, use patterns, and/or good agricultural practices.
    The Codex has established MRLs for bentazon in or on various
commodities including maize at 0.2 mg/kg, milk at 0.05 mg/kg, rice at
0.1 mg/kg, and sorghum at 0.1 mg/kg. These MRLs are different than the
tolerance established for bentazon in the United States because of
differences in animal commodity residue definition, plant use patterns,
and/or good agricultural practices.
    The Codex has established MRLs for bifenthrin in or on various
commodities including cattle fat at 0.5 mg/kg; cattle kidney and cattle
liver at 0.05 mg/kg; cattle milk at 0.05 mg/kg; chicken eggs at 0.01
mg/kg; maize fodder at 0.2 mg/kg; and strawberry at 1 mg/kg. These MRLs
are different than the tolerances established for bifenthrin in the
United States (where these commodity tolerances are higher than the
corresponding Codex MRLs) because of differences in use patterns and/or
good agricultural practices.
    The Codex has established MRLs for cyfluthrin (sum of isomers) and
beta-cyfluthrin (cyfluthrin sum of isomers) in or on various
commodities including citrus fruits at 0.3 mg/kg, citrus pulp (dry) at
2 mg/kg, liver of pigs at 0.05 mg/kg, meat (from mammals other than
marine mammals) at 1 mg/kg, fat of meat at 1 mg/kg, and chili peppers
(dry) at 1 mg/kg. These MRLs are different than the tolerances
established for cyfluthrin and beta-cyfluthrin in the United States
because of differences in use patterns and/or good agricultural
practices.
    The Codex has established MRLs for deltamethrin in or on various
commodities including fat from mammals other than marine mammals at 0.5
mg/kg, poultry fat at 0.1 mg/kg, and tomato at 0.3 mg/kg. These MRLs
are different than the tolerances established for deltamethrin in the
United States because of differences in use patterns and/or good
agricultural practices.
    The Codex has established MRLs for esfenvalerate in or on various
commodities including egg, poultry fat, poultry meat, and edible offal
of poultry at 0.01 mg/kg. These MRLs are different than the tolerances
established for esfenvalerate in the United States (where these animal
commodity tolerances are higher than the corresponding Codex MRLs)
because of differences in use patterns and/or good agricultural
practices.
    The Codex has established MRLs for ethephon in or on various
commodities including meat of cattle, goats, horses, pigs, and sheep at
0.1 mg/kg, milk of cattle, goats, and sheep at 0.05 mg/kg, poultry meat
at 0.1 mg/kg, edible offal of poultry at 0.2 mg/kg, and chicken eggs at
0.2 mg/kg. These MRLs are different than the tolerances established for
ethephon in the United States because of differences in use patterns
and/or good agricultural practices.

    The Codex has established MRLs for fenpropathrin in or on various
commodities including cattle meat at 0.5 mg/kg. The MRL is different
than the tolerance established for fenpropathrin in the United States
because of differences in use patterns and/or good agricultural
practices.
    The Codex has established MRLs for metalaxyl in or on various
commodities including citrus fruits at 5 mg/kg, dry chili peppers at 10
mg/kg, and pome fruits at 1 mg/kg. These MRLs are different than the
tolerances established for metalaxyl in the United States because of
differences in use patterns and/or good agricultural practices.

IV. Statutory and Executive Order Reviews

    In this proposed rule, EPA is proposing to revise specific
tolerance expressions to describe more clearly the measurement and
scope or coverage of the tolerances and remove expired tolerances for
quizalofop ethyl. The Office of Management and Budget (OMB) has
exempted these types of actions (e.g., tolerance actions for which
extraordinary circumstances do not exist) from review under Executive
Order 12866, entitled Regulatory Planning and Review (58 FR 51735,
October 4, 1993). Because this proposed rule has been exempted from
review under Executive Order 12866 due to its lack of significance,
this proposed rule is not subject to Executive Order 13211, entitled
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May 22, 2001). This proposed 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) (Pub. L. 104-4). Nor does it require any special considerations
as required by 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 other
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). Pursuant to the Regulatory Flexibility Act (RFA)
(5 U.S.C. 601 et seq.), the Agency previously assessed whether
establishment of tolerances, exemptions from tolerances, raising of
tolerance levels, expansion of exemptions, or revocations might
significantly impact a substantial number of small entities and
concluded that, as a general matter, these actions do not impose a
significant economic impact on a substantial number of small entities.
These analyses for tolerance establishments and modifications, and for
tolerance revocations were published on May 4, 1981 (46 FR 24950) and
on December 17, 1997 (62 FR 66020) (FRL-5753-1), respectively, and were
provided to the Chief Counsel for Advocacy of the Small Business
Administration. Taking into account this analysis, and available
information concerning the pesticides listed in this proposed rule, the
Agency hereby certifies that this proposed rule will not have a
significant negative economic impact on a substantial number of small
entities. In a memorandum dated May 25, 2001, EPA determined that eight
conditions must all be satisfied in order for an import tolerance or
tolerance exemption revocation to adversely affect a significant number
of small entity importers, and that there is a negligible joint
probability of all eight conditions holding simultaneously with respect
to any particular revocation. (This Agency document is available in the
docket of this proposed rule). Furthermore, for the pesticide named in
this proposed rule, the Agency knows of no extraordinary circumstances
that exist as to the present proposal that would change the EPA's
previous analysis. Any comments about the Agency's determination should
be submitted to the EPA along with comments on the proposal, and will
be addressed prior to issuing a final rule. In addition, the Agency has
determined that this action will not have a substantial direct effect
on States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government, as specified in Executive Order 13132,
entitled Federalism (64 FR 43255, August 10, 1999). Executive Order
13132 requires EPA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' is defined in the
Executive order to include regulations that have ``substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government.'' This
proposed rule directly regulates growers, food processors, food
handlers, and food retailers, not States. This action does not alter
the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. For these same reasons, the Agency has determined
that this proposed rule does not have any ``Tribal implications'' as
described in Executive Order 13175, entitled Consultation and
Coordination with Indian Tribal Governments (65 FR 67249, November 9,
2000). Executive Order 13175 requires EPA to develop an accountable
process to ensure ``meaningful and timely input by Tribal officials in
the development of regulatory policies that have Tribal implications.''
``Policies that have Tribal implications'' is defined in the Executive
order to include regulations that have ``substantial direct effects on
one or more Indian Tribes, on the relationship between the Federal
Government and the Indian Tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian Tribes.''
This proposed rule will not have substantial direct effects on Tribal
governments, on the relationship between the Federal Government and
Indian Tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian Tribes, as specified in
Executive Order 13175. Thus, Executive Order 13175 does not apply to
this proposed rule.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: June 6, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.

    Therefore, it is proposed that 40 CFR chapter I be amended as
follows:

PART 180--[AMENDED]

    1. The authority citation for part 180 continues to read as
follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

    2. In Sec.  180.287 revise the introductory text in paragraph (a)
to read as follows:

Sec.  180.287  Amitraz; tolerances for residues.

    (a) General. Tolerances are established for residues of the

insecticide amitraz, including its metabolites and degradates, in or on
the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only those amitraz, N '-[2,4-dimethylphenyl]-N-[[(2,4-
dimethylphenyl)imino]methyl]-N-methylmethanimidamide, residues
convertible to 2,4-dimethylaniline, expressed as the stoichiometric
equivalent of amitraz, in or on the commodity.
* * * * *
    3. Section 180.300 is amended as follows:
    i. Revise the introductory text in paragraph (a);
    ii. Revise paragraph (c).
    The revised text reads as follows:

Sec.  180.300  Ethephon; tolerances for residues.

    (a) General. Tolerances are established for residues of the plant
growth regulator ethephon, including its metabolites and degradates, in
or on the commodities in the table in this paragraph. Compliance with
the tolerance levels specified in this paragraph is to be determined by
measuring only ethephon, (P)-(2-chloroethyl)phosphonic acid, in or on
the commodity.
* * * * *
    (c) Tolerances with regional registrations. A tolerance with
regional registration, as defined in Sec.  180.1(l), of 0.1 parts per
million is established for residues of the plant growth regulator
ethephon, including its metabolites and degradates, in or on the
commodity sugarcane. Compliance with the tolerance level specified in
this paragraph is to be determined by measuring only ethephon, (P)-(2-
chloroethyl)phosphonic acid, in or on the commodity.
* * * * *
    4. Section 180.355 is amended as follows:
    i. Revise the introductory text in paragraph (a)(1);
    ii. Revise the introductory text in paragraph (a)(2);
    iii. Revise the introductory text in paragraph (c).
    The revised text reads as follows:

Sec.  180.355  Bentazon; tolerances for residues.

    (a) * * * (1) Tolerances are established for residues of the
herbicide bentazon, including its metabolites and degradates, in or on
the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only the sum of bentazon, 3-(1-methylethyl)-1H-2,1,3-
benzothiadiazin-4(3H)-one 2,2-dioxide, and its metabolites, 6-hydroxy
bentazon and 8-hydroxy bentazon, calculated as the stoichiometric
equivalent of bentazon, in or on the commodity.
* * * * *
    (2) Tolerances are established for residues of the herbicide
bentazon, including its metabolites and degradates, in or on the
commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only the sum of bentazon, 3-(1-methylethyl)-1H-2,1,3-
benzothiadiazin-4(3H)-one 2,2-dioxide, and its metabolite 2-amino-N-
isopropyl benzamide (AIBA), calculated as the stoichiometric equivalent
of bentazon, in or on the commodity.
* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in Sec.  180.1(l), are established
for residues of the herbicide bentazon, including its metabolites and
degradates, in or on the commodities in the table in this paragraph.
Compliance with the tolerance levels specified in this paragraph is to
be determined by measuring only the sum of bentazon, 3-(1-methylethyl)-
1H-2,1,3-benzothiadiazin-4(3H)-one 2,2-dioxide, and its metabolites, 6-
hydroxy bentazon and 8-hydroxy bentazon, calculated as the
stoichiometric equivalent of bentazon, in or on the commodity.
* * * * *
    5. In Sec.  180.383 revise the introductory text in paragraph (a)
to read as follows:

Sec.  180.383  Sodium salt of acifluorfen; tolerances for residues.

    (a) General. Tolerances are established for residues of the
herbicide sodium acifluorfen, including its metabolites and degradates,
in or on the commodities in the table in this paragraph. Compliance
with the tolerance levels specified in this paragraph is to be
determined by measuring only the sum of acifluorfen acid, 5-[2-chloro-
4-(trifluoromethyl)phenoxy]-2-nitrobenzoic acid, acifluorfen methyl,
methyl 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate,
acifluorfen amine, 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-
aminobenzoic acid, and acifluorfen amine methyl ester, methyl 5-[2-
chloro-4-(trifluoromethyl)phenoxy]-2-aminobenzoate, calculated as the
stoichiometric equivalent of acifluorfen acid, in or on the commodity.
* * * * *
    6. Section 180.390 is amended as follows:
    i. Revise the introductory text in paragraph (a)(1);
    ii. Revise the introductory text in paragraph (a)(2);
    iii. Revise the introductory text in paragraph (a)(3).
    The revised text reads as follows:

Sec.  180.390  Tebuthiuron; tolerances for residues.

    (a) * * * (1) Tolerances are established for residues of the
herbicide tebuthiuron, including its metabolites and degradates, in or
on the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only the sum of tebuthiuron, N-[5-(1,1-dimethylethyl)-1,3,4-
thiadiazol-2-yl]-N,N '-dimethylurea, and its metabolites N-[5-(2-
hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl]-N,N '-dimethylurea,
N-[5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl]-N-methylurea, and N-[5-
(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl]-N '-hydroxymethyl-N-
methylurea, calculated as the stoichiometric equivalent of tebuthiuron,
in or on the commodity.
* * * * *
    (2) Tolerances are established for residues of the herbicide
tebuthiuron, including its metabolites and degradates, in or on the
commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only the sum of tebuthiuron, N-[5-(1,1-dimethylethyl)-1,3,4-
thiadiazol-2-yl]-N,N '-dimethylurea, and its metabolites N-[5-(1,1-
dimethylethyl)-1,3,4-thiadiazol-2-yl]-N-methylurea, N-[5-(1,1-
dimethylethyl)-1,3,4-thiadiazol-2-yl]urea, 2-dimethylethyl-5-amino-
1,3,4-thiadiazole, and N-[5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl]-
N '-hydroxymethyl-N-methylurea, calculated as the stoichiometric
equivalent of tebuthiuron, in or on the commodity.
* * * * *
    (3) A tolerance is established for residues of the herbicide
tebuthiuron, including its metabolites and degradates, in or on the
commodity in the table in this paragraph. Compliance with the tolerance
level specified in this paragraph is to be determined by measuring only
the sum of tebuthiuron, N-[5-(1,1-dimethylethyl)-1,3,4-thiadiazol-2-
yl]-N,N '-dimethylurea, and its metabolites N-[5-(1,1-dimethylethyl)-
1,3,4-thiadiazol-2-yl]-N-methylurea, N-[5-(2-hydroxy-1,1-
dimethylethyl)-1,3,4-thiadiazol-2-yl]-N-methylurea, N-[5-(1,1-

dimethylethyl)-1,3,4-thiadiazol-2-yl]urea, N-[5-(1,1-dimethylethyl)-
1,3,4-thiadiazol-2-yl]-N '-hydroxymethyl-N-methylurea, and N-[5-(2-
hydroxy-1,1-dimethylethyl)-1,3,4-thiadiazol-2-yl]-N '-hydroxymethyl-N-
methylurea, calculated as the stoichiometric equivalent of tebuthiuron,
in milk.
* * * * *
    7. Section 180.408 is amended as follows:
    i. Revise the introductory text in paragraph (a);
    ii. Revise the introductory text in paragraph (c);
    iii. Revise the introductory text in paragraph (d).
    The revised text reads as follows:

Sec.  180.408  Metalaxyl; tolerances for residues.

    (a) General. Tolerances are established for residues of the
fungicide metalaxyl, including its metabolites and degradates, in or on
the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only metalaxyl, methyl N-(2,6-dimethylphenyl)-N-
(methoxyacetyl)-DL-alaninate, in or on the commodity.
* * * * *
    (c) Tolerances with regional registrations. A tolerance with a
regional registration, as defined in Sec.  180.1(l), is established for
residues of the fungicide metalaxyl, including its metabolites and
degradates, in or on the commodity in the table in this paragraph.
Compliance with the tolerance level specified in this paragraph is to
be determined by measuring only metalaxyl, methyl N-(2,6-
dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, in or on the commodity.
* * * * *
    (d) Indirect or inadvertent tolerances. Tolerances are established
for indirect or inadvertent residues of the fungicide metalaxyl,
including its metabolites and degradates, in or on the commodities in
the table in this paragraph when present therein as a result of the
application of metalaxyl to growing crops listed in paragraph (a) of
this section and other non-food crops. Compliance with the tolerance
levels specified in this paragraph is to be determined by measuring
only metalaxyl, methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-
alaninate, in or on the commodity.
* * * * *
    8. Section 180.435 is amended as follows:
    i. Revise the introductory text in paragraph (a)(1);
    ii. Revise paragraph (a)(2).
    The revised text reads as follows:

Sec.  180.435  Deltamethrin; tolerances for residues.

    (a) * * * (1) Tolerances are established for residues of the
insecticide deltamethrin, including its metabolites and degradates, in
or on the commodities in the table in this paragraph. Compliance with
the tolerance levels specified in this paragraph is to be determined by
measuring only the sum of deltamethrin, (S)-cyano(3-
phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate, and its major metabolites, trans
deltamethrin, (S)-alpha-cyano-m-phenoxybenzyl (1R,3S)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate and alpha-R-
deltamethrin, (R)-alpha-cyano-m-phenoxybenzyl (1R,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate, calculated as the
stoichiometric equivalent of deltamethrin, in or on the commodity.
* * * * *
    (2) A tolerance of 0.05 parts per million is established for
residues of the insecticide deltamethrin, including its metabolites and
degradates, in or on all food/feed commodities (other than those
covered by a higher tolerance as a result of use on growing crops) when
present from application of deltamethrin in food/feed handling
establishments (including food service, manufacturing and processing
establishments, such as restaurants, cafeterias, supermarkets,
bakeries, breweries, dairies, meat slaughtering and packing plants, and
canneries, feed handling establishments including feed manufacturing
and processing establishments), in accordance with the following
conditions: Application shall be limited to general surface and spot
and/or crack and crevice treatment in food/feed handling establishments
where food/feed and food/feed products are held, processed, prepared,
and served; general surface application may be used only when the
facility is not in operation, provided exposed food/feed has been
covered or removed from the area being treated; spot and/or crack and
crevice application may be used while the facility is in operation
provided exposed food/feed is covered or removed from the area being
treated prior to application; spray concentration shall be limited to a
maximum of 0.06 percent active ingredient; and contamination of food/
feed or food/feed contact surfaces shall be avoided. Compliance with
the tolerance level specified in this paragraph is to be determined by
measuring only the sum of deltamethrin, (S)-cyano(3-
phenoxyphenyl)methyl (1R,3R)-3-(2,2-dibromoethenyl)-2,2-
dimethylcyclopropanecarboxylate, and its major metabolites, trans
deltamethrin, (S)-alpha-cyano-m-phenoxybenzyl (1R,3S)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate and alpha-R-
deltamethrin, (R)-alpha-cyano-m-phenoxybenzyl (1R,3R)-3-(2,2-
dibromovinyl)-2,2-dimethylcyclopropanecarboxylate, calculated as the
stoichiometric equivalent of deltamethrin, in or on the commodity.
* * * * *
    9. Section 180.436 is amended as follows:
    i. Revise the introductory text in paragraph (a)(1);
    ii. Revise paragraph (a)(2);
    iii. Revise paragraph (a)(3);
    iv. Revise the introductory text in paragraph (a)(4).
    The revised text reads as follows:

Sec.  180.436  Cyfluthrin and the isomer beta-cyfluthrin; tolerances
for residues.

    (a) * * * (1) Tolerances are established for residues of the
insecticide cyfluthrin, including its metabolites and degradates, in or
on the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl 3-
(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on the
commodity.
* * * * *
    (2) A tolerance of 0.05 parts per million is established for
residues of the insecticide cyfluthrin, including its metabolites and
degradates, in or on food commodities exposed to the insecticide during
treatment of food-handling establishments where food and food products
are held, processed, prepared, or served, where treatments may be made
by general surface, spot, and/or crack and crevice applications, in
accordance with the following conditions: General surface treatments
shall be limited to a maximum of 3.8 grams of active ingredient per
1,000 square feet, applying to walls, floors, and ceilings with a low-
pressure system; all food processing and/or handling equipment has been
covered or removed during application; application excludes any direct
application to food products; reapplications may be made at 10-day
intervals. Crack and crevice or spot

treatments shall be limited to a maximum of 0.1 percent of the active
ingredient by weight, applied with a low-pressure system with a
pinpoint or variable-pattern nozzle. Dust formulation shall be limited
to a maximum of 0.1 percent of the active ingredient by weight, applied
using a hand duster, powder duster, or other equipment capable of
applying dust insecticide directly into voids and cracks and crevices.
Dust applications should be made in a manner to avoid deposits on
exposed surfaces or introducing the material into the air. Application
may be made provided exposed food has been covered or removed from
premises and excludes any direct application to food. Reapplications
may be made at 10-day intervals. Compliance with the tolerance level
specified in this paragraph is to be determined by measuring only
cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl 3-(2,2-
dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate, in or on the
commodity.
    (3) A tolerance of 0.05 parts per million is established for
residues of the insecticide cyfluthrin, including its metabolites and
degradates, in or on feed commodities exposed to the insecticide during
treatment of feed-handling establishments where feed and feed products
are held, processed, prepared, or served, where treatments may be made
by general surface, spot, and/or crack and crevice applications, in
accordance with the following conditions: General surface treatments
shall be limited to a maximum of 3.8 grams of active ingredient per
1,000 square feet, applying to walls, floors, and ceilings with a low-
pressure system; all feed processing and/or handling equipment has been
covered or removed during application; application excludes any direct
application to feed products; reapplications may be made at 10-day
intervals. Crack and crevice or spot treatments shall be limited to a
maximum of 0.1 percent of the active ingredient by weight, applied with
a low-pressure system with a pinpoint or variable-pattern nozzle. Dust
formulation shall be limited to a maximum of 0.1 percent of the active
ingredient by weight, applied using a hand duster, powder duster, or
other equipment capable of applying dust insecticide directly into
voids and cracks and crevices. Dust applications should be made in a
manner to avoid deposits on exposed surfaces or introducing the
material into the air. Application may be made provided exposed feed
has been covered or removed from premises and excludes any direct
application to feed. Reapplications may be made at 10-day intervals.
Compliance with the tolerance level specified in this paragraph is to
be determined by measuring only cyfluthrin, cyano(4-fluoro-3-
phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropanecarboxylate, in or on the commodity.
    (4) Tolerances are established for residues of the insecticide
beta-cyfluthrin, including its metabolites and degradates, in or on the
commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only beta-cyfluthrin, cyano(4-fluoro-3-phenoxyphenyl)methyl
3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropanecarboxylate [mixture
comprising the enantiomeric pair (R)-[alpha]-cyano-4-fluoro-3-
phenoxybenzyl (1S,3S)-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-[alpha]-cyano-4-fluoro-3-
phenoxybenzyl (1R,3R)-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate with the enantiomeric pair (R)-[alpha]-
cyano-4-fluoro-3-phenoxybenzyl (1S,3R)-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate and (S)-[alpha]-cyano-4-fluoro-3-
phenoxybenzyl (1R,3S)-3-(2,2-dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate], in or on the commodity.
* * * * *
    10. Section 180.441 is amended as follows:
    i. Revise the introductory text in paragraph (a)(1);
    ii. Revise the introductory text in paragraph (a)(2);
    iii. Revise the introductory text in paragraph (a)(3);
    iv. Remove paragraph (a)(4);
    v. Revise the introductory text in paragraph (c).
    The revised text reads as follows:

Sec.  180.441  Quizalofop ethyl; tolerances for residues.

    (a) * * * (1) Tolerances are established for residues of the
herbicides quizalofop and quizalofop ethyl, including their metabolites
and degradates, in or on the commodities in the table in this
paragraph. Compliance with the tolerance levels specified in this
paragraph is to be determined by measuring only the sum of quizalofop,
2-[4-[(6-chloro-2-quinoxalinyl)oxy]phenoxy]propanoic acid, and
quizalofop ethyl, ethyl 2-[4-[(6-chloro-2-
quinoxalinyl)oxy]phenoxy]propanoate, calculated as the stoichiometric
equivalent of quizalofop ethyl, in or on the commodity.
* * * * *
    (2) Tolerances are established for residues of the herbicides
quizalofop, quizalofop ethyl, and quizalofop methyl, including their
metabolites and degradates, in or on the commodities in the table in
this paragraph. Compliance with the tolerance levels specified in this
paragraph is to be determined by measuring only the sum of quizalofop,
2-[4-[(6-chloro-2-quinoxalinyl)oxy]phenoxy]propanoic acid, quizalofop
ethyl, ethyl 2-[4-[(6-chloro-2-quinoxalinyl)oxy]phenoxy]propanoate, and
quizalofop methyl, methyl 2-[4-[(6-chloro-2-
quinoxalinyl)oxy]phenoxy]propanoate, calculated as the stoichiometric
equivalent of quizalofop ethyl, in or on the commodity.
* * * * *
    (3) Tolerances are established for residues of the herbicide
quizalofop-p-ethyl ester, its metabolites and degradates, in or on the
commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only the sum of quizalofop-p-ethyl ester, ethyl (2R)-2-[4-
[(6-chloro-2-quinoxalinyl)oxy]phenoxy]propanoate, its acid metabolite
quizalofop-p, (2R)-2-[4-[(6-chloro-2-quinoxalinyl)oxy]phenoxy]propanoic
acid, and the S-enantiomers of both the ester and the acid, calculated
as the stoichiometric equivalent of quizalofop-p-ethyl ester, in or on
the commodity.
* * * * *
    (c) Tolerances with regional registrations. A tolerance with a
regional registration, as defined in Sec.  180.1(l), is established for
residues of the herbicide quizalofop-p-ethyl ester, its metabolites and
degradates, in or on the commodity in the table in this paragraph.
Compliance with the tolerance level specified in this paragraph is to
be determined by measuring only the sum of quizalofop-p-ethyl ester,
ethyl (2R)-2-[4-[(6-chloro-2-quinoxalinyl)oxy]phenoxy]propanoate, its
acid metabolite quizalofop-p, (2R)-2-[4-[(6-chloro-2-
quinoxalinyl)oxy]phenoxy]propanoic acid, and the S-enantiomers of both
the ester and the acid, calculated as the stoichiometric equivalent of
quizalofop-p-ethyl ester, in or on the commodity.
* * * * *
    11. Section 180.442 is amended as follows:

    i. Revise the introductory text in paragraph (a)(1);
    ii. Revise paragraph (a)(2);
    iii. Revise the introductory text in paragraph (b).
    The revised text reads as follows:

Sec.  180.442  Bifenthrin; tolerances for residues.

    (a) * * * (1) Tolerances are established for residues of the
insecticide bifenthrin, including its metabolites and degradates, in or
on the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only bifenthrin, (2-methyl[1,1'-biphenyl]-3-yl)methyl
(1R,3R)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-
dimethylcyclopropanecarboxylate, in or on the commodity.
* * * * *
    (2) A tolerance of 0.05 parts per million is established for
residues of the insecticide bifenthrin, including its metabolites and
degradates, in or on all food/feed commodities (other than those
covered by a higher tolerance as a result of use on growing crops) when
present from application of bifenthrin in food/feed handling
establishments (including food service, manufacturing and processing
establishments, such as restaurants, cafeterias, supermarkets,
bakeries, breweries, dairies, meat slaughtering and packing plants, and
canneries, feed handling establishments including feed manufacturing
and processing establishments), in accordance with the following
conditions: Application shall be limited to general surface and spot
and/or crack and crevice treatment in food/feed handling establishments
where food/feed and food/feed products are held, processed, prepared,
and served; general surface application may be used only when the
facility is not in operation, provided exposed food/feed has been
covered or removed from the area being treated; spot and/or crack and
crevice application may be used while the facility is in operation
provided exposed food/feed is covered or removed from the area being
treated prior to application; spray concentration shall be limited to a
maximum of 0.06 percent active ingredient; and contamination of food/
feed or food/feed contact surfaces shall be avoided. Compliance with
the tolerance level specified in this paragraph is to be determined by
measuring only bifenthrin, (2-methyl[1,1'-biphenyl]-3-yl)methyl
(1R,3R)-rel-3-[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-
dimethylcyclopropanecarboxylate, in or on the commodity.
    (b) Section 18 emergency exemptions. Time-limited tolerances are
established for residues of the insecticide bifenthrin, including its
metabolites and degradates, in or on the commodities in the table in
this paragraph in connection with use of the pesticide under a Section
18 emergency exemption granted by EPA. Compliance with the tolerance
levels specified in this paragraph is to be determined by measuring
only bifenthrin, (2-methyl[1,1'-biphenyl]-3-yl)methyl (1R,3R)-rel-3-
[(1Z)-2-chloro-3,3,3-trifluoro-1-propenyl]-2,2-
dimethylcyclopropanecarboxylate, in or on the commodity. The tolerances
will expire and are revoked on the date specified in the following
table.
* * * * *
    12. Section 180.466 is amended by revising the introductory text in
paragraph (a) to read as follows:

Sec.  180.466  Fenpropathrin; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide fenpropathrin, including its metabolites and degradates, in
or on the commodities in the table in this paragraph. Compliance with
the tolerance levels specified in this paragraph is to be determined by
measuring only fenpropathrin, cyano(3-phenoxyphenyl)methyl 2,2,3,3-
tetramethylcyclopropanecarboxylate, in or on the commodity.
* * * * *
    13. Section 180.494 is amended as follows:
    i. Revise the introductory text in paragraph (a);
    ii. Revise the introductory text in paragraph (c).
    The revised text read as follows:

Sec.  180.494  Pyridaben; tolerances for residues.

    (a) General. Tolerances are established for residues of the
insecticide pyridaben, including its metabolites and degradates, in or
on the commodities in the table in this paragraph. Compliance with the
tolerance levels specified in this paragraph is to be determined by
measuring only pyridaben, 4-chloro-2-(1,1-dimethylethyl)-5-[[[4-(1,1-
dimethylethyl)phenyl]methyl]thio]-3(2H)-pyridazinone, in or on the
plant commodity, and only the sum of pyridaben and its metabolites 2-
tert-butyl-5-[4-(1-carboxy-1-methylethyl)benzylthio]-4-chloropyridazin-
3(2H)-one and 2-tert-butyl-5-[4-(1,1-dimethyl-2-
hydroxyethyl)benzylthio]-4-chloropyridazin-3(2H)-one, calculated as the
stoichiometric equivalent of pyridaben, in or on the animal commodity.
* * * * *
    (c) Tolerances with regional registrations. A tolerance with
regional registration, as defined in Sec.  180.1(l), is established for
residues of the insecticide pyridaben, including its metabolites and
degradates, in or on the commodity in the table in this paragraph.
Compliance with the tolerance level specified in this paragraph is to
be determined by measuring only pyridaben, 4-chloro-2-(1,1-
dimethylethyl)-5-[[[4-(1,1-dimethylethyl)phenyl]methyl]thio]-3(2H)-
pyridazinone, in or on the commodity.
* * * * *
    14. Section 180.513 is amended as follows:
    i. Revise the introductory text in paragraph (a)(1);
    ii. Revise paragraph (a)(2).
    The revised text reads as follows:

Sec.  180.513  Chlorfenapyr; tolerances for residues.

    (a) * * * (1) A tolerance is established for residues of the
insecticide chlorfenapyr, including its metabolites and degradates, in
or on the commodity in the table in this paragraph. Compliance with the
tolerance level specified in this paragraph is to be determined by
measuring only chlorfenapyr, 4-bromo-2-(4-chlorophenyl)-1-
(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-carbonitrile, in or on
the commodity.
* * * * *
    (2) A tolerance of 0.01 parts per million is established for
residues of the insecticide chlorfenapyr, including its metabolites and
degradates, in or on all food commodities (other than those covered by
a higher tolerance as a result of use on growing crops) in accordance
with the following conditions: Application shall be no greater than a
0.5% active ingredient solution for spot, crack and crevice use in
food/feed handling areas where food/feed products are prepared, held,
processed, or served; application may only be undertaken when the
facility is not in operation, and provided exposed food/feed has been
covered, or removed from the area being treated prior to application;
food contact surfaces and equipment should be thoroughly washed with an
effective cleaning compound, and rinsed with potable water after each
use of the product; contamination of food/feed or food/feed

contact surfaces shall be avoided; and application excludes any direct
application to any food/feed, food/feed packaging, or any food/feed
contact surfaces. Compliance with the tolerance level specified in this
paragraph is to be determined by measuring only chlorfenapyr, 4-bromo-
2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl)-1H-pyrrole-3-
carbonitrile, in or on the commodity.
* * * * *
    15. Section 180.533 is amended as follows:
    i. Revise the introductory text in paragraph (a)(1);
    ii. Revise paragraph (a)(2);
    iii. Revise the introductory text in paragraph (c).
    The revised text reads as follows:

Sec.  180.533  Esfenvalerate; tolerances for residues.

    (a) * * * (1) Tolerances are established for residues of the
insecticide esfenvalerate, including its metabolites and degradates, in
or on the commodities in the table in this paragraph. Compliance with
the tolerance levels specified in this paragraph is to be determined by
measuring only the sum of esfenvalerate, (S)-cyano(3-
phenoxyphenyl)methyl ([alpha]S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, its non-racemic isomer (R)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, and its diastereoisomers (S)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate
and (R)-cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, calculated as the stoichiometric equivalent
of esfenvalerate, in or on the commodity.
* * * * *
    (2) A tolerance of 0.05 parts per million in or on raw agricultural
food commodities (other than those food commodities already covered by
a higher tolerance as a result of use on growing crops) is established
for residues of the insecticide esfenvalerate, including its
metabolites and degradates, as a result of the use of esfenvalerate in
food-handling establishments. Compliance with the tolerance levels
specified in this paragraph is to be determined by measuring only the
sum of esfenvalerate, (S)-cyano(3-phenoxyphenyl)methyl (S)-4-chloro-
[alpha]-(1-methylethyl)benzeneacetate, its non-racemic isomer (R)-
cyano(3-phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, and its diastereoisomers (S)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate
and (R)-cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, calculated as the stoichiometric equivalent
of esfenvalerate, in or on the commodity.
* * * * *
    (c) Tolerances with regional registrations. Tolerances with
regional registration, as defined in Sec.  180.1(l), are established
for residues of the insecticide esfenvalerate, including its
metabolites and degradates, in or on the commodities in the table in
this paragraph. Compliance with the tolerance levels specified in this
paragraph is to be determined by measuring only the sum of
esfenvalerate, (S)-cyano(3-phenoxyphenyl)methyl (S)-4-chloro-[alpha]-
(1-methylethyl)benzeneacetate, its non-racemic isomer (R)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, and its diastereoisomers (S)-cyano(3-
phenoxyphenyl)methyl-(R)-4-chloro-[alpha]-(1-methylethyl)benzeneacetate
and (R)-cyano(3-phenoxyphenyl)methyl-(S)-4-chloro-[alpha]-(1-
methylethyl)benzeneacetate, calculated as the stoichiometric equivalent
of esfenvalerate, in or on the commodity.
* * * * *
[FR Doc. 2011-14827 Filed 6-14-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 87 (Tuesday, May 5, 2020)]
[Notices]
[Page 26698]
[FR Doc No: 2020-09501]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4509-DR; Docket ID FEMA-2020-0001]

North Dakota; Major Disaster and Related Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This is a notice of the Presidential declaration of a major
disaster for the State of North Dakota (FEMA-4509-DR), dated April 1,
2020, and related determinations.

DATES: The declaration was issued April 1, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter
dated April 1, 2020, the President issued a major disaster declaration
under the authority of the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''), as follows:

    I have determined that the emergency conditions in the State of
North Dakota resulting from the Coronavirus Disease 2019 (COVID-19)
pandemic beginning on January 20, 2020, and continuing, are of
sufficient severity and magnitude to warrant a major disaster
declaration under the Robert T. Stafford Disaster Relief and
Emergency Assistance Act, 42 U.S.C. 5121 et seq. (the ``Stafford
Act''). Therefore, I declare that such a major disaster exists in
the State of North Dakota.
    In order to provide Federal assistance, you are hereby
authorized to allocate from funds available for these purposes such
amounts as you find necessary for Federal disaster assistance and
administrative expenses.
    You are authorized to provide assistance for emergency
protective measures (Category B), including direct Federal
assistance, under the Public Assistance program throughout the
State. Consistent with the requirement that Federal assistance be
supplemental, any Federal funds provided under the Stafford Act for
Public Assistance will be limited to 75 percent of the total
eligible costs.
    Further, you are authorized to make changes to this declaration
for the approved assistance to the extent allowable under the
Stafford Act.

    The Federal Emergency Management Agency (FEMA) hereby gives notice
that pursuant to the authority vested in the Administrator, under
Executive Order 12148, as amended, Lee K. dePalo, of FEMA is appointed
to act as the Federal Coordinating Officer for this major disaster.
    The following areas of the State of North Dakota have been
designated as adversely affected by this major disaster:

    Emergency protective measures (Category B) not authorized under
other Federal statutes, including direct Federal assistance, under
the Public Assistance program at 75 percent federal funding for all
areas in the State of North Dakota.

The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households In
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-09501 Filed 5-4-20; 8:45 am]
 BILLING CODE 9111-23-P


[Federal Register: February 20, 2008 (Volume 73, Number 34)]
[Notices]
[Page 9342]
[DOCID:fr20fe08-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0053]

Draft Guidance for Industry on Good Reprint Practices for the
Distribution of Medical Journal Articles and Medical or Scientific
Reference Publications on Unapproved New Uses of Approved Drugs and
Approved or Cleared Medical Devices; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Good Reprint
Practices for the Distribution of Medical Journal Articles and Medical
or Scientific Reference Publications on Unapproved New Uses of Approved
Drugs and Approved or Cleared Medical Devices.'' The draft guidance
provides drug, biologics, and device manufacturers with the agency's
views on the distribution of medical journal articles and scientific or
medical reference publications that discuss unapproved new uses for FDA
approved drugs or biologics or FDA approved or cleared medical devices
to health care professionals and health care entities.

DATES: Submit written or electronic comments on the draft guidance by
April 21, 2008. General comments on agency guidance documents are
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Policy (HF-11), Office of Commissioner, Food
and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send
one self-addressed adhesive label to assist that office in processing
your requests. Submit electronic requests for copies of the draft
guidance to http://www.fda.gov/oc/op/goodreprint.html. Submit written

comments on the draft guidance to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
 See the SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jarilyn Dupont, Office of Policy,
Office of Commissioner, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Good Reprint Practices for the Distribution of Medical
Journal Articles and Medical or Scientific Reference Publications on
Unapproved New Uses of Approved Drugs and Approved or Cleared Medical
Devices.'' The draft guidance provides drug, biologics, and device
manufacturers with the agency's views on the distribution of medical
journal articles and scientific or medical reference publications that
discuss unapproved new uses for FDA approved drugs (including
biologics) or FDA approved or cleared medical devices to health care
professionals and health care entities.
    On September 30, 2006, section 401 of the Food and Drug
Administration Modernization Act (FDAMA) (section 551 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 360aaa)) ceased to be in
effect. The provision described certain conditions under which a drug
or medical device manufacturer could disseminate medical and scientific
information discussing unapproved uses of approved drugs and cleared or
approved medical devices to health care professionals and certain
entities (including pharmacy benefits managers, health insurance
issuers, group health plans, and Federal or State governmental
agencies). Section 401 of FDAMA provided that, if the described
conditions were met, dissemination of such journal articles or
reference publications would not be considered as evidence of the
manufacturer's intent that the product be used for an unapproved new
use. FDA implementing regulations were codified at 21 CFR part 99.
    In light of the sunset of section 401 of FDAMA and in recognition
of the public health value to health care professionals of receiving
scientific and medical information, FDA is providing its current views
and recommendations concerning ``Good Reprint Practices'' for the
dissemination of medical journal articles and medical or scientific
reference publications on unapproved uses of drugs and medical devices.
FDA's legal authority to determine whether distribution of medical or
scientific information constitutes promotion of an unapproved ``new
use,'' or whether such activities cause a product to be misbranded or
adulterated has not changed.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the agency's current thinking on the
dissemination of medical journal articles and medical or scientific
reference publications on unapproved uses of approved drugs and
approved or cleared medical devices to health care professionals and
health care entities. It does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
    Please note that as of January 15, 2008, the FDA Web site
transitioned to the Federal Dockets Management System (FDMS). FDMS is a
Government-wide, electronic docket management system. Electronic
submissions will be accepted by FDA only through FDMS.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: February 13, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 08-746 Filed 2-15-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 82, Number 248 (Thursday, December 28, 2017)]
[Rules and Regulations]
[Page 61485]
[FR Doc No: 2017-27976]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

49 CFR Part 219

[Docket No. FRA-2001-11213, Notice No. 22]

Drug and Alcohol Testing: Determination of Minimum Random Testing
Rates for 2018

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Notification of determination.

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SUMMARY: This notification of determination announces the FRA
Administrator's minimum annual random drug and alcohol testing rates
for calendar year 2018.

DATES: This notification of determination is effective December 28,
2017.

FOR FURTHER INFORMATION CONTACT: Jerry Powers, FRA Drug and Alcohol
Program Manager, W33-310, Federal Railroad Administration, 1200 New
Jersey Avenue SE, Washington, DC 20590 (telephone<PHONE_NUMBER>); or Sam
Noe, FRA Drug and Alcohol Program Specialist (telephone<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION: For the next calendar year, FRA determines
the minimum annual random drug testing rate and the minimum annual
random alcohol testing rate for railroad employees covered by hours of
service laws and regulations (covered service employees) based on the
railroad industry data available for the two previous calendar years
(for this document, calendar years 2015 and 2016). Railroad industry
data submitted to FRA's Management Information System (MIS) shows the
rail industry's random drug testing positive rate for covered service
employees has continued to be below 1.0 percent for the applicable two
calendar years. FRA's Administrator has therefore determined the
minimum annual random drug testing rate from January 1, 2018 through
December 31, 2018, will remain at 25 percent of covered service
employees under Sec.  219.602 of FRA's drug and alcohol rule (49 CFR
part 219). In addition, because the industry-wide random alcohol
testing violation rate for covered service employees has continued to
be below 0.5 percent for the applicable two calendar years, the
Administrator has determined the minimum annual random alcohol testing
rate will remain at 10 percent of covered service employees from
January 1, 2018 through December 31, 2018, under Sec.  219.608. Because
these rates represent minimums, railroads may conduct FRA random
testing of covered service employees at higher rates.
    On June 12, 2017, maintenance-of-way (MOW) employees became subject
to FRA random drug and alcohol testing. In the final rule which
expanded the scope of part 219 to include MOW employees (81 FR 37894,
June 10, 2016), FRA had set the initial minimum annual random testing
rates for MOW employees at 50 percent of MOW employees for drugs and 25
percent of MOW employees for alcohol; FRA had set identical initial
minimum random testing rates for covered employees when they first
became subject to random testing. Unlike covered employees, however,
FRA does not yet have two full years of MIS data to gauge the industry-
wide random drug and random alcohol positive rates for MOW employees.
For this reason, FRA's Administrator has determined that for MOW
employees, from January 1, 2018 through December 31, 2018, the minimum
annual random drug testing rate will remain at 50 percent of MOW
employees, and the minimum annual random alcohol testing rate will
remain at 25 percent of MOW employees. As with covered service
employees, because these rates represent minimums, railroads may
conduct FRA random testing of MOW employees at higher rates.

    Issued in Washington, DC, on December 21, 2017.
Juan D. Reyes, III,
Chief Counsel.
[FR Doc. 2017-27976 Filed 12-27-17; 8:45 am]
 BILLING CODE 4910-06-P