Document ID: EPA-HQ-OPP-2011-0697-0001
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances for Emergency Exemptions: Cyazofamid
Posted Date: 2012-01-27T05:00Z

[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Rules and Regulations]
[Pages 4248-4252]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1815]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0697; FRL-9332-5]

Cyazofamid; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for 
residues of cyazofamid in or on basil, fresh and dried. This action is 
in response to EPA's granting of an emergency exemption under section 
18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
authorizing use of the pesticide on basil. This regulation establishes 
a maximum permissible level for residues of cyazofamid in or on these 
commodities. The time-limited tolerances expire on December 31, 2014.

DATES: This regulation is effective January 27, 2012. Objections and 
requests for hearings must be received on or before March 27, 2012, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2011-0697. All documents in the 
docket are listed in the docket index available in http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (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 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 Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Princess Campbell, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 308-8033; email address: 
campbell.princess@epa.gov.

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. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl. To access the 
harmonized test guidelines referenced in this document electronically, 
please go to http://www.epa.gov/ocspp and select ``Test Methods and 
Guidelines.''

C. How can I file an objection or hearing request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect 
of this regulation and may also request a hearing on those objections. 
You must file your objection or request a hearing on this regulation in 
accordance with the instructions provided in 40 CFR part 178. To ensure 
proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-
2011-0697 in the subject line on the first page of your submission. All 
objections and requests for a hearing must be in writing, and must be 
received by the Hearing Clerk on or before March 27, 2012. Addresses 
for mail and hand delivery of objections and hearing requests are 
provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket. Information not marked confidential pursuant to 40 CFR part 2 
may be disclosed publicly by EPA without prior notice. Submit a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2011-0697, 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 (703) 305-5805.

II. Background and Statutory Findings

    EPA, on its own initiative, in accordance with sections 408(e) and 
408(l)(6) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances 
for combined residues of the fungicide cyazofamid, in or on fresh basil 
at 12 parts per million (ppm), and on dried basil at 144 ppm. These 
time-limited tolerances expire on December 31, 2014.

[[Page 4249]]

    Section 408(l)(6) of FFDCA requires EPA to establish a time-limited 
tolerance or exemption from the requirement for a tolerance for 
pesticide chemical residues in food that will result from the use of a 
pesticide under an emergency exemption granted by EPA under section 18 
of FIFRA. Such tolerances can be established without providing notice 
or period for public comment. EPA does not intend for its actions on 
FIFRA section 18 related time-limited tolerances to set binding 
precedents for the application of section 408 of FFDCA and the safety 
standard to other tolerances and exemptions. Section 408(e) of FFDCA 
allows EPA to establish a tolerance or an exemption from the 
requirement of a tolerance on its own initiative, i.e., without having 
received any petition from an outside party.
    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a 
tolerance (the legal limit for a pesticide chemical residue in or on a 
food) only if EPA determines that the tolerance is ``safe.'' Section 
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a 
reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. * * 
*''
    Section 18 of FIFRA authorizes EPA to exempt any Federal or State 
agency from any provision of FIFRA, if EPA determines that ``emergency 
conditions exist which require such exemption.'' EPA has established 
regulations governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Cyazofamid on Basil and FFDCA Tolerances

    The Illinois Department of Agriculture (IDA) submitted a Section 18 
Specific Exemption request (10IL02). After having reviewed the 
submission, EPA determined that an emergency condition exists for this 
State, and that the criteria for approval of an emergency exemption 
were met. EPA has authorized a specific exemption under FIFRA section 
18 for the use of cyazofamid on basil for control of downy mildew 
(Peronospora balbahrii) in Illinois. This new food use for cyazofamid 
triggered the requirement for the establishment of tolerances under 
FFDCA.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of cyazofamid in 
or on basil. In doing so, EPA considered the safety standard in section 
408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under 
section 408(l)(6) of FFDCA would be consistent with the safety standard 
and with FIFRA section 18. Consistent with the need to move quickly on 
the emergency exemption in order to address an urgent non-routine 
situation and to ensure that the resulting food is safe and lawful, EPA 
is issuing this tolerance without notice and opportunity for public 
comment as provided in section 408(l)(6) of FFDCA. Although these time-
limited tolerances expire on December 31, 2014, under section 408(l)(5) 
of FFDCA, residues of the pesticide not in excess of the amounts 
specified in the tolerance remaining in or on basil after that date 
will not be unlawful, provided the pesticide was applied in a manner 
that was lawful under FIFRA, and the residues do not exceed a level 
that was authorized by these time-limited tolerances at the time of 
that application. EPA will take action to revoke these time-limited 
tolerances earlier if any experience with, scientific data on, or other 
relevant information on this pesticide indicate that the residues are 
not safe.
    Because these time-limited tolerances are being approved under 
emergency conditions, EPA has not made any decisions about whether 
cyazofamid meets FIFRA's registration requirements for use on basil or 
whether permanent tolerances for this use would be appropriate. Under 
these circumstances, EPA does not believe that this time-limited 
tolerance decision serves as a basis for registration of cyazofamid by 
a State for special local needs under FIFRA section 24(c). Nor does 
this tolerance by itself serve as the authority for persons in any 
State other than Illinois to use this pesticide on the applicable crops 
under FIFRA section 18 absent the issuance of an emergency exemption 
applicable within that State. For additional information regarding the 
emergency exemption for cyazofamid, contact the Agency's Registration 
Division at the address provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

    Consistent with the factors specified in FFDCA section 
408(b)(2)(D), EPA has reviewed the available scientific data and other 
relevant information in support of this action. EPA has sufficient data 
to assess the hazards of and to make a determination on aggregate 
exposure expected as a result of this emergency exemption request and 
the time-limited tolerances for combined residues of cyazofamid on 
fresh basil at 12 ppm, and on dried basil at 144 ppm. EPA's assessment 
of exposures and risks associated with establishing time-limited 
tolerances follows.

A. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    A summary of the toxicological endpoints for cyazofamid used for 
human risk assessment is discussed in Unit III. B. of the final rule 
published in the Federal Register of July 14, 2010 (75 FR 40745) (FRL-
8833-1).

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to cyazofamid, EPA considered exposure under the time-

[[Page 4250]]

limited tolerances established by this action as well as all existing 
cyazofamid tolerances in 40 CFR 180.601. EPA assessed dietary exposures 
from cyazofamid in food as follows:
    i. Acute exposure. No acute toxicity endpoint was identified for 
cyazofamid for the general population including infants and children, 
because no acute effects were observed which could be attributed to a 
single-dose exposure. Nevertheless, EPA estimated acute exposure for 
the subpopulation, females 13-49 years, based on the developmental 
toxicity risk. In estimating acute dietary exposure, EPA used food 
consumption information from the United States Department of 
Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of 
Food Intake by Individuals (CSFII). Tolerance level residues and 100 
percent crop treated (PCT) assumptions were used. Anticipated residues 
and PCT information were not used.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. Tolerance level residues and 100 PCT assumptions were 
used. Anticipated residues and PCT information were not used.
    iii. Cancer. Based on the data summarized in Unit III.A., July 14, 
2010, and at http://www.regulation.gov in document ``Cyazofamid. Human 
Health Risk Assessment for Proposed Section 18 Use on Basil, item 4.4 
Dietary Exposure and Risk,'' p.14, EPA has concluded that cyazofamid 
does not pose a cancer risk to humans. Cyazofamid has been classified 
as ``not likely to be carcinogenic in humans,'' based on the absence of 
significant tumor increases in two rodent carcinogenic studies. 
Therefore, a dietary exposure assessment for the purpose of assessing 
cancer risk is unnecessary.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for cyazofamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of cyazofamid. Further information regarding EPA 
drinking water models used in pesticide exposure assessment can be 
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the Pesticide Root Zone Model/Exposure Analysis Modeling 
System (PRZM/EXAMS), the estimated drinking water concentrations 
(EDWCs) of cyazofamid for acute exposures are estimated to be 136 parts 
per billion (ppb) for surface water and 2.18 ppb for ground water. For 
chronic exposures for non-cancer assessments EDWCs are estimated to be 
133 ppb for surface water and 2.18 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 136 ppb was used to assess 
the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 133 ppb was used to assess 
the contribution to drinking water.
    3. Sources of non-dietary exposure. The term ``residential 
exposure'' is used in this document to refer to non-occupational, non-
dietary exposure (e.g., for lawn and garden pest control, indoor pest 
control, termiticides, and flea and tick control on pets).
    Cyazofamid is currently registered for the following uses that 
could result in residential exposures: Commercially-treated residential 
turf and ornamentals. EPA assessed residential exposure using the 
following assumptions: Non-occupational handler exposures are not 
expected; however, post-application exposure is possible for children 
and adults. Non-occupational/residential MOEs were estimated for ``Day 
0'' exposure. The post-application children's aggregate MOE (including 
incidental oral exposures) is 1,600. The Agency is concerned when MOEs 
are <100. All MOEs, including the children's aggregate, are >100, and 
therefore not a risk concern.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at: http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found cyazofamid to share a common mechanism of 
toxicity with any other substances, and cyazofamid does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
cyazofamid does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

C. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the Food Quality 
Protection Act (FQPA) Safety Factor (SF). In applying this provision, 
EPA either retains the default value of 10X, or uses a different 
additional SF when reliable data available to EPA support the choice of 
a different factor.
    2. Prenatal and postnatal sensitivity. The prenatal and postnatal 
toxicology database for cyazofamid includes rat and rabbit 
developmental toxicity studies and a 2-generation reproduction toxicity 
study in rats. There was some evidence of increased susceptibility 
following in utero exposure to rats in the prenatal developmental 
toxicity study; the increased incidence of bent ribs in the high dose 
fetuses was considered adverse and was used for setting the 
developmental NOAEL/LOAEL.
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for cyazofamid is sufficient to 
characterize the hazard, to conduct FQPA assessment, and to select 
toxicity endpoints for risk assessment. Under current data requirement 
guidelines, functional immunotoxicity data (OPPTS 780.7800) is a data 
gap. However, the cyazofamid toxicology database does not show any 
evidence of biologically relevant effects on the immune system that 
relate to this chemical. The Agency does not believe that conducting a 
functional immunotoxicity study will result in a lower NOAEL than the 
regulatory dose for this risk assessment, and an additional uncertainty 
factor (UF) for the data gap is unnecessary.
    ii. There is no indication that cyazofamid is a neurotoxic chemical 
and there is no need for a developmental neurotoxicity study or 
additional UFs to account for

[[Page 4251]]

neurotoxicity for this time-limited tolerance.
    iii. There was some evidence of increased susceptibility following 
in utero exposure to rats in the prenatal developmental toxicity study. 
As described earlier, the increased incidence of bent ribs in the high 
dose fetuses was considered adverse and was used for setting the 
developmental NOAEL/LOAEL. EPA considers this approach conservative and 
highly protective because bent ribs are a reversible developmental 
anomaly rather than a malformation.
    iv. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 100 PCT and tolerance-level residues. EPA made conservative 
(protective) assumptions in the ground and surface water modeling used 
to assess exposure to cyazofamid in drinking water. EPA used similarly 
conservative assumptions to assess post-application exposure of 
children as well as incidental oral exposure of toddlers. These 
assessments will not underestimate the exposure and risks posed by 
cyazofamid.

D. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to cyazofamid will occupy 1.2% of the aPAD for females 13-49 years, the 
only subpopulation assessed. For the population of concern, the acute 
dietary (food and drinking water) risk assessment represents acute 
aggregate risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
cyazofamid from food and water will utilize <1% of the cPAD for 
children 1-2 years old, the population group receiving the greatest 
exposure. Based on the explanation in Unit III.C.3. regarding 
residential use patterns, chronic residential exposure to residues of 
cyazofamid is not expected.
    3. Short-term and intermediate term risk. Short-term and 
intermediate-term risks have been assessed together because both 
scenarios have the same endpoints and PODs. Short-intermediate term 
aggregate exposure takes into account short-intermediate term 
residential exposure plus chronic exposure to food and drinking water 
(considered to be a background exposure level). Cyazofamid is currently 
registered for uses that could result in short-term and/or intermediate 
term residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-intermediate term residential exposures to cyazofamid.
    Using the exposure assumptions described in this unit for short-
intermediate term exposures, EPA has concluded the combined short-
intermediate term food, water, and residential exposures result in 
aggregate MOEs of >100 for all scenarios. Because EPA's level of 
concern for cyazofamid is a MOE of 100 or below, these MOEs are not of 
concern.
    4. Aggregate cancer risk for U.S. population. Based on the lack of 
evidence of carcinogenicity in two adequate rodent (both the rat and 
the mouse) carcinogenicity studies, cyazofamid is not expected to pose 
a cancer risk to humans.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children, from aggregate 
exposure to cyazofamid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodologies are available to enforce the 
tolerance expression. Cyazofamid its and metabolite CCIM are completely 
recovered (>80% recovery) using FDA's Multiresidue Protocol D (without 
cleanup). In addition, an acceptable high performance liquid 
chromatography/ultraviolet/detector (HPLC/UV) method (``Independent 
Laboratory Validation of the Residue Method for IKF-916 and CCIM in 
Tomatoes'', Document Number 013033-0, Pyxant Labs Inc., with slight 
modification) is available for use as a single analyte confirmatory 
method.
    The method may be requested from: Chief, Analytical Chemistry 
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 
20755-5350; telephone number: (410) 305-2905; email address: 
residuemethods@epa.gov.

B. 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 cyazofamid on basil.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
cyazofamid, 4-chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-
imidazole-1-sulfonamide,and its metabolites and degradates in or on 
basil, fresh, at 12 ppm, and basil, dried, at 144 ppm. These tolerances 
expire on December 31, 2014.

VII. Statutory and Executive Order Reviews

    This final rule establishes time-limited tolerances under sections 
408(e) and 408(l)(6) of FFDCA. 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 final rule has been exempted from review 
under Executive Order 12866, this final 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) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). 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., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income

[[Page 4252]]

Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established in accordance 
with sections 408(e) and 408(l)(6) of FFDCA, such as the tolerances in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of section 408(n)(4) of FFDCA. As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled Federalism (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
Consultation and Coordination with Indian Tribal Governments (65 FR 
67249, November 9, 2000) do not apply to this final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
    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).

VIII. Congressional Review Act

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

List of Subjects in 40 CFR Part 180

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

    Dated: January 18, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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

0
2. Section 180.601 is amended by revising paragraph (b) to read as 
follows:

Sec.  [emsp14]180.601  Cyazofamid; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances are 
established for residues of the fungicide cyazofamid, including its 
metabolites and degradates, in or on the commodities in the following 
table. Compliance with the tolerance levels specified in the following 
table is to be determined by measuring only the sum of cyazofamid, 4-
chloro-2-cyano-N,N-dimethyl-5-(4-methylphenyl)-1H-imidazole-1-
sulfonamide and its metabolite CCIM, 4-chloro-5-(4-methylphenyl)-1H-
imidazole-2-carbonitrile, calculated as the stoichiometric equivalent 
of cyazofamid, resulting from use of the pesticide under FIFRA section 
18 emergency exemptions. The tolerances expire and are revoked on the 
date specified in the table.

------------------------------------------------------------------------
                                                            Expiration/
                Commodity                    Parts per      revocation
                                              million          date
------------------------------------------------------------------------
Basil, dried............................             144        12/31/14
Basil, fresh............................              12        12/31/14
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[FR Doc. 2012-1815 Filed 1-26-12; 8:45 am]
BILLING CODE 6560-50-P