[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Rules and Regulations]
[Pages 55799-55804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22983]



40 CFR Part 180

[EPA-HQ-OPP-2011-0639; FRL-8886-8]

Mandipropamid; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.


SUMMARY: This regulation establishes time-limited tolerances for 
residues of mandipropamid in or on basil, fresh and basil, 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 mandipropamid 
in or on these commodities. The time-limited tolerances expire on 
December 31, 2012.

[[Page 55800]]

DATES: This regulation is effective September 9, 2011. Objections and 
requests for hearings must be received on or before November 8, 2011, 
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-2011-0639. 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) 

FOR FURTHER INFORMATION CONTACT: Marcel Howard, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6784; e-mail address: [email protected].


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 

 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.

 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-
2011-0639 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 November 8, 2011. 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-2011-0639, 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 FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing 
time-limited tolerances for residues of mandipropamid, 4-chloro-N-[2-
benzeneacetamide, in or on basil, fresh at 20 parts per million (ppm) 
and basil, dried at 240 ppm. These time-limited tolerances expire on 
December 31, 2012.
    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 * * 

[[Page 55801]]

    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 Mandipropamid on Basil and FFDCA 

    The Applicant stated that a new, destructive fungal pathogen, known 
as downy mildew (Peronospora belbahrii), has been identified in 
Illinois and it resulted in a 50% yield loss in basil production using 
registered alternatives. Illinois recently experienced some atypical 
weather conditions (high moisture and temperatures) that were conducive 
to the development and spread of the disease. The increase presence of 
the disease and the zero tolerance policy for downy mildew adopted by 
the distributors led basil grower to seek a spray program to maintain 
season-long control of this disease. The registered alternatives have 
been deemed inadequate for season-long control due to product 
application restrictions or lack of product efficacy. The Applicant 
stated that because of the favorable weather conditions and the 
inadequacy of the registered alternatives to achieve season-long 
control of the downy mildew, an emergency situation exists and 
significant economic losses will likely incur. Further, the Applicant 
asserts that without a suitable additional fungicide, such as 
mandipropamid, to address the issue, the future viability of basil 
industry in Illinois is threatened. 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 are 
met. EPA has authorized a specific exemption under FIFRA section 18 for 
the use of mandipropamid on basil for control of downy mildew in 
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of mandipropamid 
in or on basil, fresh and basil, dried. 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, 2012, 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, fresh and basil, dried 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 
mandipropamid 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 mandipropamid 
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 mandipropamid, contact the Agency's 
Registration Division at the address provided under FOR FURTHER 

IV. Aggregate Risk Assessment and Determination of Safety

    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 * * 
    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 residues of mandipropamid on basil, 
fresh at 20 ppm and basil, dried at 240 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 mandipropamid used for 
human risk assessment is discussed in Unit III. of the final rule 
published in the Federal Register of January 16, 2008 (73 FR 2812) 

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to mandipropamid, EPA

[[Page 55802]]

considered exposure under the time-limited tolerances established by 
this action as well as all existing mandipropamid tolerances in 40 CFR 
180.637. EPA assessed dietary exposures from mandipropamid in food as 
    i. Acute exposure. No such effects were identified in the 
toxicological studies for mandipropamid; therefore, a quantitative 
acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 CSFII. As to residue levels in food, EPA relied upon permanent 
tolerance level residues established for mandipropamid and 100 percent 
crop treated (PCT) information for all agricultural commodities. An 
unrefined chronic exposure assessment that assumes 100 PCT was 
conducted for the proposed Section 18 uses of mandipropamid. The parent 
mandipropamid is the residue of concern for tolerance monitoring, and 
mandipropamid and its major aquatic degradates (SYN 500003 and SYN 
5044851) for the risk assessment.
    iii. Cancer. EPA has determined that mandipropamid is classified as 
``not likely to be a human carcinogen'' based on the absence of 
treatment-related increases in tumors in the rat and mouse 
carcinogenicity studies. Therefore, an exposure assessment to evaluate 
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for mandipropamid. Tolerance level residues and 100 PCT were assumed 
for all food commodities.
    2. Dietary exposure from drinking water. The Agency used screening 
level water exposure models in the dietary exposure analysis and risk 
assessment for mandipropamid in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of mandipropamid. 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 First Index Reservoir Screening Tool (FIRST) and 
Screening Concentration in Ground Water (SCI-GROW) models, the 
estimated drinking water concentrations (EDWCs) of mandipropamid for 
acute exposures are estimated to be 25.2 parts per billion (ppb) for 
surface water and 0.05 ppb for ground water. The estimated 
environmental concentrations (EECs) for the aquatic degradates SYN 
500003 and SYN 504851 are estimated to be 2.32 and 8.99 ppb for surface 
water and 0.6 and 1.7 ppb for ground water, respectively. The combined 
level of mandipropamid and the degradates in surface water is 36.5 ppb.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 36.5 ppb was used to 
assess the contribution to drinking water.
    3. From 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).
    Mandipropamid is not registered for any specific use patterns that 
would result in residential exposure.
    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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to mandipropamid and any 
other substances, and mandipropamid does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has not assumed that mandipropamid has 
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 the policy statements released by EPA's Office of 
Pesticide Programs concerning common mechanism determinations and 
procedures for cumulating effects from substances found to have a 
common mechanism on 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. There is no evidence 
(quantitative or qualitative) of increased susceptibility and no 
residual uncertainties with regard to prenatal toxicity following in 
utero exposure to rats or rabbits (developmental studies) and prenatal 
and/or postnatal exposures to rats (reproduction study).
    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 
    i. The toxicity database for mandipropamid is complete except that 
EPA has determined that an immunotoxicity study is required as per the 
revised 40 CFR part 158. However, there is no need for an additional 
uncertainty factor while the immunotoxicity study is completed. The 
overall weight of evidence in terms of hematology, clinical chemistry, 
organ weights, and/or histopathology indicates that mandipropamid does 
not directly target the immune system. Therefore, EPA does not 
anticipate that conducting a functional immunotoxicity study will 
result in a lower point of departure than currently selected for the 
overall risk assessment. The immunotoxicity study should be conducted 
in conjunction with any future petition for the section 3 registration 
of mandipropamid.
    ii. There is no indication that mandipropamid is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that mandipropamid results in increased 
susceptibility in in utero rats or rabbits in the prenatal 
developmental studies or in young rats in the 2-generation reproduction 
    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

[[Page 55803]]

mandipropamid in drinking water. EPA used similarly conservative 
assumptions to assess postapplication exposure of children as well as 
incidental oral exposure of toddlers. These assessments will not 
underestimate the exposure and risks posed by mandipropamid.

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 linear 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. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
mandipropamid is not expected to pose an acute risk.
    2. Chronic risk. There are no residential uses for mandipropamid, 
and therefore aggregate risk is equal to that from consumption of food 
and water. EPA has concluded that chronic exposure to mandipropamid 
from food and water will utilize 44% of the cPAD for (children 1 to 2 
years of age) the population group receiving the greatest exposure, 
while the general U.S. population utilizes 26% of the cPAD.
    3. Short-term and intermediate risk. Short-term aggregate exposure 
takes into account short-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level). Mandipropamid is not registered or proposed for use on any 
sites that would result in residential exposure. Therefore, the 
aggregate risk is the sum of the risk from food and water, which was 
previously addressed.
    4. Aggregate cancer risk for U.S. population. As explained in this 
unit, mandipropamid is not likely to be carcinogenic in 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 mandipropamid residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (German Multi-residue Method DFG 
S-19) is available to enforce the tolerance expression. 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; e-mail address: [email protected].

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.
    There are no specific Codex, Canadian or Mexican maximum residue 
limits (MRL) for mandipropamid in or on basil.

VI. Conclusion

    Therefore, time-limited tolerances are established for residues of 
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
[alpha]-(2-propynyloxy)- benzeneacetamide, in or on basil, fresh at 20 
ppm and basil, dried at 240 ppm. These tolerances expire on December 
31, 2012.

VII. Statutory and Executive Order Reviews

    This final rule establishes 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 
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 

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

[[Page 55804]]

the Congress and to the Comptroller General of the United States. EPA 
will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
this final rule in the Federal Register. This final rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

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

    Dated: August 31, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:


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

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

2. Section 180.637 is amended by revising paragraph (b) to read as 

Sec.  [emsp14]180.637  Mandipropamid; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of the 
mandipropamid, 4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
[alpha]-(2-propynyloxy)-benzeneacetamide in or on the specified 
agricultural commodities, resulting from use of the pesticide pursuant 
to FFIFRA section 18 emergency exemptions. The tolerances expire on the 
date specified in the table.

                                                 Parts per    Expiration
                   Commodity                      million        date
Basil, dried..................................          240     12/31/12
Basil, fresh..................................           20     12/31/12

* * * * *
[FR Doc. 2011-22983 Filed 9-8-11; 8:45 am]