Document ID: EPA-HQ-OPP-2006-0234-0023
Agency: epa
Document Type: Rule
Title: Gentamicin; Pesticide Tolerance for Emergency Exemptions
Posted Date: 2008-07-30T04:00Z

[Federal Register: July 30, 2008 (Volume 73, Number 147)]
[Rules and Regulations]               
[Page 44157-44162]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30jy08-13]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0234; FRL-8370-8]

 
Gentamicin; Pesticide Tolerance 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 gentamicin 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 pesticide on apples. This regulation establishes a maximum 
permissible level for residues of gentamicin in this food commodity. 
The time-limited tolerance expires and is revoked on December 31, 2010.

DATES: This regulation is effective July 30, 2008. Objections and 
requests for hearings must be received on or before September 29, 2008, 
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-2006-0234. To access the 
electronic docket, go to http://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov website to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in 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 either in the electronic docket at http://
www.regulations.gov, or, if only available in hard copy, at the Office 
of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S-4400, One 
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The 
hours of operation of this Docket Facility are from 8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays. The Docket 
Facility telephone number is (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:

[[Page 44158]]

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 Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket 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 40 CFR part 180 through the 
Government Printing Office's pilot e-CFR site at http://
www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the Federal Food, Drug, and Cosmetic Act 
(FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA), 
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-2006-0234 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 on or 
before September 29, 2008.
    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-2006-0234, 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'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 antibiotic 
gentamicin, in or on apples at 0.10 parts per million (ppm). This time-
limited tolerance expires and is revoked on December 31, 2010. 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 
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 Gentamicin on Apples and FFDCA Tolerances

    The State of Michigan requested the use of gentamicin on apples due 
to the development of resistance of fire blight to the pesticide 
streptomycin and the lack of viable control options. 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 gentamicin 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 gentamicin 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

[[Page 44159]]

opportunity for public comment as provided in section 408(l)(6) of 
FFDCA. Although this time-limited tolerance expires and is revoked on 
December 31, 2010, under section 408(l)(5) of FFDCA, residues of the 
pesticide not in excess of the amount 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 
this time-limited tolerance at the time of that application. EPA will 
take action to revoke this time-limited tolerance earlier if any 
experience with, scientific data on, or other relevant information on 
this pesticide indicate that the residues are not safe.
    Because this time-limited tolerance is being approved under 
emergency conditions, EPA has not made any decisions about whether 
gentamicin meets FIFRA's registration requirements for use on apples or 
whether a permanent tolerance 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 gentamicin 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 this crop under FIFRA section 18 
absent the issuance of an emergency exemption applicable within that 
State. For additional information regarding the emergency exemption for 
gentamicin, 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 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 tolerance for residues of gentamicin on apples at 0.10 
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 effect 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 
are observed 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-term, intermediate-term, 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 gentamicin used for 
human risk assessment can be found at http://www.regulations.gov in the 
document registration 06MI01. ``Section 18 Emergency Exemption 
for the application of Gentamicin Sulfate to Apples. Human-Health Risk 
Assessment'' pages 25-26 in docket ID number EPA-HQ-OPP-2006-0234.

B. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to gentamicin, EPA considered exposure under the time-limited 
tolerance established by this action. EPA assessed dietary exposures 
from gentamicin in food as follows:
    i. Acute exposure. No such effects were identified in the 
toxicological studies for gentamicin; therefore, a quantitative acute 
dietary exposure assessment is unnecessary.
    ii. Chronic exposure. A Tier 1 chronic dietary-exposure assessment 
was conducted using the established/recommended tolerances for all food 
commodities, 100% crop treated information for all proposed and 
existing uses, and DEEMTM Version 7.81 default processing 
factors for some processed commodities. Drinking water was incorporated 
directly into the dietary assessment using the EDWC generated by 
GENEEC2.
    iii. Cancer. A cancer dietary exposure assessment was not performed 
for gentamicin because gentamicin is not likely to be carcinogenic to 
humans.
    iv. Anticipated residue and percent crop treated (PCT) information. 
EPA did not use anticipated residue and/or PCT information in the 
dietary assessment for gentamicin. Tolerance level residues and/or 100% 
CT 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 gentamicin in drinking water. These simulation models 
take into account data on the physical, chemical, and fate/transport 
characteristics of gentamicin. 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.
    A Tier I Generic Expected Environmental Concentration (GENEEC2) 
screening model was used to determine estimated surface water 
concentrations of gentamicin following 3 applications to apples.

[[Page 44160]]

    Based on the GENEEC2 model described above, the highest estimated 
drinking water concentration (EDWC) of gentamicin for chronic exposure 
is estimated to be 45.08 ppb for ground water and surface water. 
Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model (DEEM Version 7.81). The 
modeled exposure scenario was conservative, as compared to the section 
18 use pattern.
    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).
    Gentamicin 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 gentamicin to share a common mechanism of 
toxicity with any other substances, and gentamicin does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
gentamicin 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 
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 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. Based on data reviewed by 
the Agency, there is no evidence of increased susceptibility in the 
developmental studies in rats, rabbits, mice, and guinea pigs. 
Furthermore, there is no evidence in increased susceptibility in the 2-
generation reproduction study in rats. In all studies, gentamicin was 
tested parentrally, which is very conservative since about 1% of the 
oral dose is absorbed. The doses tested in these studies are 100-fold 
higher than the hypothetical oral dose. Therefore, there is no residual 
uncertainty for prenatal and/or postnatal susceptibility
    3. Conclusion. EPA has determined that reliable data show that the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for gentamicin is complete.
    ii. There is no indication that gentamicin 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 gentamicin results in increased 
susceptibility in the developmental studies in rats, rabbits, mice, and 
guinea pigs. There is no evidence of increased susceptibility in the 2-
generation reproduction study in rats.
    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 water and surface water modeling 
used to assess exposure to gentamicin in drinking water. These 
assessments will not underestimate the exposure and risks posed by 
gentamicin.

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-term, intermediate-term, 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, gentamicin 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 exposure to 
gentamicin from food and water will utilize 1% of the cPAD for the U.S. 
population, 4% of the cPAD for all infants less than 1 year old, and 3% 
of the cPAD for children 1-2 years old. All other population subgroups 
utilize 2% or less of the cPAD. There are no residential uses for 
gentamicin that result in chronic residential exposure to gentamicin.
    3. Short-term and intermediate-term risk. Short-term and 
intermediate-term aggregate exposure takes into account short-term 
residential exposure plus chronic exposure to food and water 
(considered to be a background exposure level).
    Gentamicin is not registered for any use patterns that would result 
in residential exposure. Therefore, the short-term aggregate risk is 
the sum of the risk from exposure to gentamicin through food and water 
and will not be greater than the chronic aggregate risk.
    4. Aggregate cancer risk for U.S. population. Gentamicin is not 
likely to be carcinogenic to humans and is therefore not expected to 
pose a cancer risk.
    5. Pharmaceutical aggregate risk. Section 408 of the FFDCA requires 
EPA to consider potential sources of exposure to a pesticide and 
related substances in addition to the dietary sources expected to 
result from a pesticide use subject to the tolerance. In order to 
determine whether to maintain a pesticide tolerance, EPA must 
``determine that there is a reasonable certainty of no harm.'' Under 
FFDCA section 505, the Food and Drug Administration (FDA) reviews human 
drugs for safety and effectiveness and may approve a drug 
notwithstanding the possibility that some users may experience adverse 
side effects. EPA does not believe that, for purposes of the section 
408 dietary risk assessment, it is compelled to treat a pharmaceutical 
user the same as a non-user, or to assume that combined exposures to

[[Page 44161]]

pesticide and pharmaceutical residues that lead to a physiological 
effect in the user constitutes ``harm'' under the meaning of section 
408 of the FFDCA. Rather, EPA believes the appropriate way to consider 
the pharmaceutical use of gentamicin in its risk assessment is to 
examine the impact that the additional nonoccupational pesticide 
exposures would have to a pharmaceutical user exposed to a related (or, 
in some cases, the same) compound. Where the additional pesticide 
exposure has no more than a minimal impact on the pharmaceutical user, 
EPA could make a reasonable certainty of no harm finding for the 
pesticide tolerances of that compound under section 408 of the FFDCA. 
If the potential impact on the pharmaceutical user as a result of co-
exposure from pesticide use is more than minimal, then EPA would not be 
able to conclude that dietary residues were safe, and would need to 
discuss with FDA appropriate measures to reduce exposure from one or 
both sources.
    The pesticidal exposure estimates reflect the dietary dose from 
pesticidal uses of gentamicin that a user treated with a pharmaceutical 
gentamicin product would receive in a reasonable worst-case scenario. 
EPA's pesticide exposure assessment has taken into consideration the 
appropriate population, exposure route, and exposure duration for 
comparison with exposure to the pharmaceutical use of gentamicin.
    EPA estimates that the pharmaceutical gentamicin exposure a user is 
expected to receive from a typical therapeutic dose (3-7.5 milligrams/
kilogram/day (mg/kg/day)) is 2,400 to 6,000 times greater than the 
estimated dietary exposure from the pesticidal sources of gentamicin 
(0.001229 mg/kg/day). Therefore, because the pesticide exposure has no 
more than a minimal impact on the total dose to a pharmaceutical user, 
EPA believes that there is a reasonable certainty that the potential 
dietary pesticide exposure will result in no harm to a user being 
treated therapeutically with gentamicin. FDA has been made aware of 
EPA's conclusions regarding pesticide exposure in users receiving 
treatment with a pharmaceutical gentamicin drug product.
    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 gentamicin 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 Codex maximum residue limits (MRLs) for residues of 
gentamicin on apples.

VI. Conclusion

    Therefore, a time-limited tolerance is established for residues of 
gentamicin per se, in or on apple at 0.10 ppm. The tolerance expires 
and is revoked on December 31, 2010.

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under sections 408(e) and 
408(l)(6) 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 rule 
has been exempted from review under Executive Order 12866, this rule is 
not subject to Executive Order 13211, 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 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 rule. In addition, This 
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: July 17, 2008.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

[[Page 44162]]

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 180.642 is added to read as follows:

Sec.  180.642  Gentamicin; tolerances for residues.

    (a) General. [Reserved].
    (b) Section 18 emergency exemptions. Time-limited tolerances 
specified in the following table are established for residues of 
gentamicin in or on the specified agricultural commodities, resulting 
from use of the pesticide pursuant to FIFRA section 18 emergency 
exemptions. The tolerances expire and are revoked on the date specified 
in the following table.

----------------------------------------------------------------------------------------------------------------
                Commodity                    Parts per million               Expiration/revocation date
----------------------------------------------------------------------------------------------------------------
Apple                                                        0.10                              December 31, 2010
----------------------------------------------------------------------------------------------------------------

    (c) Tolerance with regional restrictions. [Reserved]
    (d) Indirect or inadvertent residues. [Reserved]
[FR Doc. E8-17337 Filed 7-29-08; 8:45 am]

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