Document ID: EPA-HQ-OPP-2008-0695-0008
Agency: epa
Document Type: Rule
Title: Pesticide Tolerances for Emergency Exemptions: Kasugamycin
Posted Date: 2010-04-14T04:00Z

[Federal Register: April 14, 2010 (Volume 75, Number 71)]
[Rules and Regulations]               
[Page 19268-19272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14ap10-18]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0695; FRL-8808-7]

 
Kasugamycin; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes a time-limited tolerance for 
residues of kasugamycin, 3-O-[2-amino-4-[(carboxyiminomethyl)amino]-
2,3,4,6-tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in 
or on apples. 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 
agricultural bactericide on apples. This regulation establishes a 
maximum permissible level for residues of kasugamycin in this food 
commodity. The time-limited tolerance expires and is revoked on 
December 31, 2012.

DATES: This regulation is effective April 14, 2010. Objections and 
requests for hearings must be received on or before June 14, 2010, 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-2008-0695. 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: Andrew Ertman, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-9367; e-mail address: ertman.andrew@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://
www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines 
referenced in this document electronically, please go to http://
www.epa.gov/oppts and select ``Test Methods and Guidelines.''

C. 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. 
The EPA procedural regulations which govern the submission of 
objections and requests for hearings appear in 40 CFR part 178. 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-
2008-0695 in the subject line on the first page of your submission. All

[[Page 19269]]

requests must be in writing, and must be mailed or delivered to the 
Hearing Clerk on or before June 14, 2010.
    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 your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0695, 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 a 
time-limited tolerance for residues of the agricultural bactericide 
kasugamycin,3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in or on 
apples at 0.05 parts per million (ppm). This time-limited tolerance 
expires and is revoked on December 31, 2012. EPA will publish a 
document in the Federal Register to remove the revoked tolerances from 
the CFR.
    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 new 
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 Kasugamycin on Apples and FFDCA Tolerances

    The State of Michigan requested the use of kasugamycin on apples to 
control severe infestations of the bacteria responsible for the disease 
fire blight. After having reviewed the submission, EPA determined that 
emergency conditions exist for this State, and that the criteria for an 
emergency exemption are met. EPA has authorized under FIFRA section 18 
the use of kasugamycin on apples for control of fire blight in 
Michigan.
    As part of its evaluation of the emergency exemption application, 
EPA assessed the potential risks presented by residues of kasugamycin 
in or on apples. 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 and are revoked 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 
apples 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 
kasugamycin meets FIFRA's registration requirements for use on apples 
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 kasugamycin by 
a State for special local needs under FIFRA section 24(c). Nor does 
this tolerance serve as the basis for persons in any State other than 
Michigan to use this pesticide on these crops under FIFRA section 18 
absent the issuance of an emergency exemption applicable within that 
State. For additional information regarding the emergency exemption for 
kasugamycin, contact the Agency's Registration Division at the address 
provided under FOR FURTHER INFORMATION CONTACT.

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

[[Page 19270]]

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 kasugamycin, 3-O-[2-amino-
4-[(carboxyiminomethyl)amino]-2,3,4,6-tetradeoxy-[alpha]-D-arabino-
hexopyranosyl]-D-chiro-inositol on apples at 0.05 ppm. EPA's assessment 
of exposures and risks associated with establishing time-limited 
tolerances follows.

A. 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 kasugamycin used for 
human risk assessment can be found at http://www.regulations.gov in 
document ``Kasugamycin. Human Health Risk Assessment for the Proposed 
Food/Feed Use of the Fungicide (Associated with Section 18 
Registration) on Apples in Michigan,'' page 8 in docket ID number EPA-
HQ-OPP-2008-0695. On page 9 of that assessment there is also a 
qualitative evaluation of the risks for development of resistant 
pathogenic bacteria, in consideration of factors recommended by public 
health experts to sustain the effectiveness of antibiotic materials. 
Field use of this chemical under the section 18 involved measures and 
requirements to limit, manage, and monitor for resistant bacteria. The 
terms of use are included in this docket.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to kasugamycin, EPA considered exposure under the time-limited 
tolerances established by this action as well as all existing 
kasugamycin tolerances in (40 CFR 180.614). EPA assessed dietary 
exposures from kasugamycin in food as follows:
    i. Acute exposure. No such effects were identified in the 
toxicological studies for kasugamycin; 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 assumed 100 percent 
crop treated (PCT) and default processing factors were used. The 
chronic dietary assessment is highly conservative, and therefore 
provides an upper-bound estimate of dietary exposure and risk.
    iii. Cancer. Kasugamycin has been classified by the Agency as not 
likely to be carcinogenic to humans and therefore, a cancer exposure 
assessment was not conducted.
    iv. Anticipated residue and PCT information. EPA did not use 
anticipated residue and/or PCT information in the dietary assessment 
for kasugamycin. Tolerance level residues and/or 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 kasugamycin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of kasugamycin. 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 kasugamycin for 
chronic exposures for non-cancer assessments are estimated to be 0.0214 
ppb for surface water and 0.278 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For chronic dietary risk 
assessment, the water concentration of value 0.278 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).
    Kasugamycin 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 kasugamycin to share a common mechanism of 
toxicity with any other substances, and kasugamycin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
kasugamycin 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 the policy statements 
released by EPA's Office of Pesticide Programs concerning common

[[Page 19271]]

mechanism determinations and procedures for cumulating effects from 
substances found to have a common mechanism on EPA's website 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 FQPA 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. No increased quantitative or 
qualitative susceptibility was observed in the developmental rat or 
rabbit studies or in the 2-generation reproduction study. No offspring 
toxicity was observed at any of the doses tested in these three 
studies. Reproductive toxicity was noted in the F1 generation of the 2-
generation reproduction study. However, because parental toxicity 
(decreased body weights and body weight gains) occurred at a lower dose 
than that which resulted in effects on reproduction, there is no 
increased quantitative or qualitative susceptibility of the offspring.
    3. Conclusion. There was no evidence of neurotoxicity in any of the 
studies available in the toxicology database, including the subchronic 
feeding studies, the chronic feeding studies, the developmental 
toxicity studies, and the 2-generation reproduction study. Therefore, 
acute and subchronic neurotoxicity studies are not required. A 
developmental neurotoxicity study is not required because:
    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 kasugamycin is considered adequate to 
characterize potential toxic effects on infants and children.
    ii. There is no indication that kasugamycin 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 kasugamycin 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 kasugamycin in drinking water. These assessments 
will not underestimate the exposure and risks posed by kasugamycin.

D. 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, therefore, no acute dietary endpoint was selected. 
Therefore, kasugamycin 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 
kasugamycin from food and water will utilize 20% of the cPAD for all 
infants less than 1 year old, the population group receiving the 
greatest exposure. There are no residential uses for kasugamycin.
    3. Short-and intermediate term risk. Short- and intermediate-term 
aggregate exposure take into account short- and intermediate-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Kasugamycin is not registered for any use patterns that would 
result in residential exposure. Therefore, the short- and intermediate-
term aggregate risk is the sum of the risk from exposure to kasugamycin 
through food and water and will not be greater than the chronic 
aggregate risk.
    4. Aggregate cancer risk for U.S. population. Kasugamycin is 
classified as a not likely to be carcinogenic to humans, and therefore, 
EPA does not expect kasugamycin to pose a cancer risk.
    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 kasugamycin residues.

V. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology 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: residuemethods@epa.gov.

B. International Residue Limits

    There are no established Canadian, Mexican, or Codex Maximum 
Residue Limits (MRLs) for kasugamycin residues in apple commodities.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
kasugamycin, 3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in or on 
apples at 0.05 ppm. This tolerance expires and is revoked on December 
31, 2012.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance 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

[[Page 19272]]

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 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).

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. 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: April 1, 2010.
Lois Rossi,
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 180.614 is amended by revising paragraph (b) to read as 
follows:

Sec.  180.614  Kasugamycin; tolerances for residues.

* * * * *
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
kasugamycin, 3-O-[2-amino-4-[(carboxyiminomethyl)amino]-2,3,4,6-
tetradeoxy-[alpha]-D-arabino-hexopyranosyl]-D-chiro-inositol in or on 
the specified agricultural commodities, resulting from use of the 
pesticide pursuant to FFIFRA section 18 emergency exemptions. The 
tolerances expire and are revoked on the date specified in the table.

------------------------------------------------------------------------
                                                          Expiration/
            Commodity              Parts per million    revocation date
------------------------------------------------------------------------
Apple                             0.05                12/31/12
------------------------------------------------------------------------

* * * * *

[FR Doc. 2010-8133 Filed 4-13-10; 8:45 am]
BILLING CODE 6560-50-S