Document ID: EPA-HQ-OPP-2007-0461-0015
Agency: epa
Document Type: Rule
Title: Mandipropamid; Pesticide Tolerances
Posted Date: 2009-07-10T04:00Z

[Federal Register: July 10, 2009 (Volume 74, Number 131)]
[Rules and Regulations]               
[Page 33165-33170]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10jy09-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-0461; FRL-8422-5]

 
Mandipropamid; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a tolerance for residues of 
mandipropamid in or on hops, dried cones. Syngenta Crop Protection, 
Inc. requested this tolerance under the Federal Food, Drug, and 
Cosmetic Act (FFDCA).

DATES: This regulation is effective July 10, 2009. Objections and 
requests for hearings must be received on or before September 8, 2009, 
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-2007-0461. 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., 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: Rose Mary Kearns, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 305-5611; e-mail address: 
kearns.rosemary@epa.gov.

[[Page 33166]]

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 those 
engaged in the following activities:
     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 to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of EPA's tolerance regulations 
at 40 CFR part 180 through the Government Printing Office's e-CFR cite 
at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of 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-2007-0461 in the subject line on the first 
page of your submission. All requests must be in writing, and must be 
mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 
on or before September 8, 2009.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit this copy, identified by docket ID number 
EPA-HQ-OPP-2007-0461, 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. Petition for Tolerance

    In the Federal Register of June 13, 2008, (73 FR 33814) (FRL-8367-
3), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
8F7342) by Syngenta Crop Protection, Inc., 410 Swing Road, P.O. Box 
18300, Greensboro, NC 27419. The petition requested that 40 CFR 180.637 
be amended by establishing tolerances for residues of the fungicide 
mandipropamid [4-chloro-N-[2-[3-methoxy-4-(2-propynyloxy)phenyl]ethyl]-
a-(2-propynyloxy)-benzeneacetamide], regulated chemical, in or on hops, 
at 50 parts per million (ppm). That notice referenced a summary of the 
petition prepared by Syngenta Crop Protection, Inc, the registrant, 
which is available to the public in the docket, http://
www.regulations.gov. There were no comments received in response to the 
notice of filing.
    Based upon review of the data supporting the petition, EPA has 
changed the requested commodity ``hops'' to ``hop, dried cones.'' The 
reason for this change is explained in Unit IV.C.

III. 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 section 408(b)(2)(D) of FFDCA, and the factors 
specified in section 408(b)(2)(D) of FFDCA, 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 for the petitioned-for 
tolerances for residues of mandipropamid on hop, dried cones at 50 ppm. 
EPA's assessment of exposures and risks associated with establishing 
tolerances follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children.
    Mandipropamid has low or minimal acute toxicity via the oral, 
dermal, and inhalation routes of exposure. It is minimally irritating 
to the eye and non-irritating to the skin. It is also negative for skin 
sensitization.
    Liver toxicity was the primary effect and was observed in rats, 
mice, and dogs. In the 24-month rat study, nephrotoxicity was observed 
in males only. The lack of liver toxicity in this long-term study was 
probably due to the lower doses when compared with the 90-day study. In 
a 90-day rat study, there was slight hepatotoxicity in both

[[Page 33167]]

sexes; there was the suggestion of effects on the liver in the 90-day 
mouse study in which increased liver weights in both sexes and 
microscopic pathology were observed. In the 90-day dog study liver 
effects included increased cholesterol, increased liver weights and 
liver enzymes (alkaline phosphatase activity, alanine aminotransferase) 
and increased pigment in hepatocytes and Kupffer cells in both sexes. 
Additionally, centrilobular hepatocyte vacuolation in females was 
observed. In the combined chronic/carcinogenicity rat study, no effects 
on the liver were noted at doses up to and including the highest dose 
tested (HDT) of 61/70 mg/kg/day (M/F); however, increased 
nephrotoxicity occurred in males. No liver effects were observed in the 
mouse carcinogenicity study at doses up to 223/285 mg/kg/day (M/F). The 
following effects on the liver were present in the 1-year dog study: 
Increased incidence and severity of microscopic pigment in the liver 
and increased alkaline phosphatase activity in both sexes, as well as 
increased alanine aminotransferase activity in males. Therefore, 
effects on the liver of rats, mice and dogs appear within 90-days (also 
in the 1-year dog study); whereas, in the 24-month rat study, only 
nephrotoxicity was observed and, in the 18-month mouse study, only 
decreased body weight and food utilization was noted.
    There was no evidence of teratogenicity or indications of increased 
neonatal sensitivity in the developmental and reproduction toxicity 
studies. In the rat and rabbit developmental toxicity studies, there 
were no treatment-related maternal or developmental effects observed up 
to the limit dose of 1,000 mg/kg/day. In the 2-generation rat 
reproduction study, the only parental/systemic effects were decreased 
body weights, body weight gains, food consumption and food utilization 
in males. No effects on reproduction were observed at any dose. 
Offspring effects were decreased pup body weights in both sexes, but 
this effect occurred at doses which also caused effects in parental 
animals.
    Dermal exposure to mandipropamid for 28-days in the rat did not 
result in systemic or dermal toxicity up to the limit dose of 1000 mg/
kg/day. There was no evidence of developmental effects, neurotoxicity, 
mutagenicity or carcinogenicity after exposure to mandipropamid.
     Specific information on the studies received and the nature of the 
adverse effects caused by mandipropamid as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies are discussed in the final rule 
published in the Federal Register of January 16, 2008, (73 FR 2812) 
(FRL-8346-6).

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-, intermediate-
, and chronic-term risks are evaluated by comparing food, water, and 
residential exposure to the POD to ensure that the margin of exposure 
(MOE) called for by the product of all applicable UFs is not exceeded. 
This latter value is referred to as the Level of Concern (LOC).
    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 
greater than that 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.B. of the final rule 
published in the Federal Register of January 16, 2008.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to mandipropamid, EPA considered exposure under the 
petitioned-for tolerance as well as all existing mandipropamid 
tolerances in (40 CFR 180.637). EPA assessed dietary exposures from 
mandipropamid in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk 
assessments are performed for a food-use pesticide, if a toxicological 
study has indicated the possibility of an effect of concern occurring 
as a result of a 1-day or single 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 used tolerance level 
residues and assumed 100 percent of all crops are treated 100 percent 
crop treated (PCT).
    iii. Cancer. EPA has determined that mandipropamid classified as 
``not likely to be carcinogenic to humans'' based on the absence of 
treatment-related increases in tumors in rat and mouse carcinogenicity 
studies. Therefore, there is no cancer risk associated with the 
proposed use of mandipropamid.
    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/or 100 PCT were assumed 
for all food commodities.
    Section 408(b)(2)(E) of FFDCA authorizes EPA to use available data 
and information on the anticipated residue levels of pesticide residues 
in food and the actual levels of pesticide residues that have been 
measured in food. If EPA relies on such information, EPA must require 
pursuant to FFDCA section 408(f)(1) that data be provided 5 years after 
the tolerance is established, modified, or left in effect, 
demonstrating that the levels in food are not above the levels 
anticipated. For the present action, EPA will issue such data call-ins 
as are required by FFDCA section 408(b)(2)(E) and authorized under 
FFDCA section 408(f)(1). Data will be required to be submitted no later 
than 5 years from the date of issuance of these tolerances.
    EPA did not use PCT information in assessing dietary exposure to 
mandipropamid.
    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

[[Page 33168]]

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.
    The Agency used the FIRST (Version 1.1.0) model for estimation of 
surface water and the Screening Concentration in Ground Water (SCI-
GROW, Version 2.3) model, for estimation of ground water to determine 
estimated drinking water concentrations (EDWC) of mandipropamid.
    For chronic exposures for non-cancer assessment the EDWCs are 
estimated to be 36.5 ppb for surface water and 2.4 ppb for ground 
water.
    Modeled estimates of surface water 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.''
    EPA has not found mandipropamid to share a common mechanism of 
toxicity with 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 assumed that 
mandipropamid 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 website at http://
www.epa.gov/pesticides/cumulative.

D. 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 FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor 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 pre and/
or post-natal exposures to rats (reproduction study).
    3. Conclusion. EPA has determined that reliable data show 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 mandipropamid is not complete because 
an immunotoxicity study is required. Despite this data gap, EPA has 
concluded that the database is adequate to assess the pre- and 
postnatal toxicity of mandipropamid and that there is no need for an 
additional database uncertainty factor to account for the missing 
study.
    EPA began requiring functional immunotoxicity testing of all food 
and nonfood use pesticides on December 26, 2007. This study is not yet 
available for mandipropamid. EPA has evaluated the available 
mandipropamid toxicity studies for evidence of potential 
immunotoxicity, including hematology, gross organ weights for spleen 
and thymus, clinical chemistry and histopathology, to determine if an 
additional database uncertainty factor is needed to account for 
potential immunotoxicity. The overall weight of evidence suggests that 
mandipropamid does not directly target the immune system. Therefore, 
the Agency does not believe that conducting a functional immunotoxicity 
study will result in a lower POD than the currently selected for 
overall risk assessment, and therefore, a database uncertainty (UFDB) 
is not needed to account for the lack of this study.
    ii. There is no indication that mandipropamid is a neurotoxic 
chemical and there is no need for a developmental neurotoxicity study 
or additional 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 
study.
    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 mandipropamid in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
mandipropamid.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic pesticide exposures are 
safe by comparing aggregate exposure estimates to the aPAD and cPAD. 
The aPAD and cPAD represent the highest safe exposures, taking into 
account all appropriate SFs. EPA calculates the aPAD and cPAD by 
dividing the POD by all applicable UFs. For linear cancer risks, EPA 
calculates the probability of additional cancer cases 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 POD to ensure that the MOE called for 
by the product of all applicable UFs is not exceeded.
    1. Acute risk. An acute aggregate risk assessment takes into 
account exposure estimates from acute 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. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
mandipropamid from food and water will utilize 30% of the cPAD for 
(children 1-2 years of age) the population group receiving the greatest 
exposure. There are no residential uses for mandipropamid.
    3. Short-term 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 for any use patterns that would 
result in

[[Page 33169]]

residential exposure. Therefore, a short-term aggregate risk assessment 
was not needed.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Mandipropamid is not registered for any use patterns that would 
result in intermediate-term residential exposure. Therefore, an 
intermediate-term aggregate risk was not needed.
    5. Aggregate cancer risk for U.S. population. Based on the absence 
of treatment-related increases in tumors in rat and mouse 
carcinogenicity studies with mandipropamid, EPA concludes that 
mandipropamid does not pose a cancer risk.
    6. 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.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology (liquid chromatography with tandem 
mass spectrometry (LC/MS/MS)) is available to enforce tolerances for 
mandipropamid. 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: 
residuemethods@epa.gov.

B. International Residue Limits

    There are no specific Codex, Canadian, or Mexican maximum residue 
limits (MRLs) for mandipropamid.

C. Revisions to Petitioned-For Tolerances

    EPA changed the requested commodity ``hops'' to ``hop, dried 
cones'' to harmonize with accepted tolerance terminology.

V. Conclusion

    Therefore, tolerances are established for residues of 
mandipropamid, [4-chloro-N-[2-[3-methoxy-4-(2-
propynyloxy)phenyl]ethyl]-a-(2-propynyloxy)-benzeneacetamide in or on 
hop, dried cones at 50 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes tolerances under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. 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 on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance 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) (Public Law 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).

VII. 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. 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: June 23, 2009.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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 180.637 is amended by alphabetically adding the following 
commodity to the table in paragraph (a) to read as follows:

Sec. 180.637  Mandipropamid; tolerances for residues.

    (a) General. * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Hop, dried cones...............................                       50
                                * * * * *
------------------------------------------------------------------------

[[Page 33170]]

* * * * *

[FR Doc. E9-16369 Filed 7-9-09; 8:45 am]

BILLING CODE 6560-50-S