[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]
BILLING CODE 6560-50-S