Coumaphos; Pesticide Tolerances for Emergency Exemptions

Note: EPA no longer updates this information, but it may be useful as a reference or resource.

[Federal Register: August 16, 2000 (Volume 65, Number 159)]
[Rules and Regulations]
[Page 49927-49936]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16au00-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301039; FRL-6738-3]
RIN 2070-AB78

Coumaphos; Pesticide Tolerances for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes time-limited tolerances for
combined residues of coumaphos (O,O-diethyl O-3-chloro-4-methyl-2-oxo-
2H-1-benzopyran-7-yl phosphorothioate) and its oxygen analog,
coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl
phosphate in or on honey and beeswax. This action is in response to
EPA's granting of an emergency exemption under section 18 of the
Federal Insecticide, Fungicide, and Rodenticide Act authorizing use of
the pesticide in beehives. This regulation establishes maximum
permissible levels for residues of coumaphos in these food commodities.
These tolerances will expire and are revoked on December 31, 2002.

DATES: This regulation is effective August 16, 2000. Objections and
requests for hearings, identified by docket control number OPP-301039,
must be received by EPA on or before October 16, 2000.

ADDRESSES: Written objections and hearing requests may be submitted by
mail, in person, or by courier. Please follow the detailed instructions
for each method as provided in Unit VII. of the SUPPLEMENTARY
INFORMATION. To ensure proper receipt by EPA, your objections and
hearing requests must identify docket control number OPP-301039 in the
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Barbara Madden, Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
telephone number: (703) 305-6463; and e-mail address:
madden.barbara@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 categories and entities may include, but are not
limited to:

------------------------------------------------------------------------
Examples of
Categories NAICS codes Potentially
Affected Entities
------------------------------------------------------------------------
Industry 111 Crop production
112 Animal production
311 Food manufacturing
32532 Pesticide
manufacturing
------------------------------------------------------------------------

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 the table could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether or not this action might apply to certain entities. If you have
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 Additional Information, Including Copies of This
Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this
document, and certain other related documents that might be available
electronically, from the EPA Internet Home Page at http://www.epa.gov/.
To access this document, on the Home Page select ``Laws and
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the
entry for this document under the ``Federal Register--Environmental
Documents.'' You can also go directly to the Federal Register listings
at http://www.epa.gov/fedrgstr/.
2. In person. The Agency has established an official record for
this action under docket control number OPP-301039. The official record
consists of the documents specifically referenced in this action, and
other information related to this action, including any information
claimed as Confidential Business Information (CBI).

[[Page 49928]]

This official record includes the documents that are physically located
in the docket, as well as the documents that are referenced in those
documents. The public version of the official record does not include
any information claimed as CBI. The public version of the official
record, which includes printed, paper versions of any electronic
comments submitted during an applicable comment period is available for
inspection in the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA,
from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

EPA, on its own initiative, in accordance with sections 408(l)(6)
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, is
establishing tolerances for combined residues of the insecticide
coumaphos (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl
phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-
chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphate, in or on honey at
0.1 part per million (ppm) and beeswax at 100 ppm. These tolerances
will expire and are revoked on December 31, 2002. EPA will publish a
document in the Federal Register to remove the revoked tolerance from
the Code of Federal Regulations.
Section 408(l)(6) of the 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 tolerances to set binding precedents for the
application of section 408 and the new safety standard to other
tolerances and exemptions.
Section 408(b)(2)(A)(i) of the 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) 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)
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 the Federal Insecticide, Fungicide, and Rodenticide
Act (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.'' This provision was not amended by
the Food Quality Protection Act (FQPA). EPA has established regulations
governing such emergency exemptions in 40 CFR part 166.

III. Emergency Exemption for Coumaphos on Honey and Beeswax and
FFDCA Tolerances

The varroa mite (Varroa jacobsoni Oudemans) is an ectoparasite of
honey bees. It was first detected in the continental United States in
Maryland in 1979, and found in Florida and Wisconsin by 1987. Currently
it is the most important pest of honey bee colonies. The mites feed on
the hemolymph of the developing bee larva, pupa, and adult bees. Dead
or dying newly emerged bees have malformed wings, legs, abdomens, and
thoraces. Recent anecdotal evidence suggests that bee viruses and
varroa mites are closely linked to the demise of honey bee colonies.
The mites have been shown to activate some of these, usually benign,
viruses; causing virus outbreaks that ultimately lead to colony
mortality.
Fluvalinate is currently registered for the control of varroa mites
however, populations of varroa mites have developed resistance to
fluvalinate. Varroa mite resistance to fluvalinate has been well
documented by the United States Department of Agriculture (USDA),
Agricultural Research Service (ARS). According to USDA, ARS many hives
treated with fluvalinate have resulted in wholesale colony losses. Due
to the destructive nature of this pest coupled with the importance of
honey bees (for honey production and pollination of numerous
agricultural crops) to the U.S. economy, it is imperative that
alternative means of controlling the varroa mite be developed.
Currently, coumaphos is the only pesticide that has been identified as
an effective alternative to fluvalinate. Extensive efficacy trials,
performed in laboratories in the U.S.A. and abroad, have revealed that
coumaphos will significantly reduce populations of varroa mites without
causing any appreciable mortality to adult honey bees or their brood.
The small hive beetle (Aethina tumida Murray) was discovered for
the first time in the continental U.S. (in Florida) in May 1998. The
beetles infest European honey bee colonies and feed on stored pollen
and honey. The adult beetles have a thick integument that protects them
from bee stings. Hive combs are destroyed and developing bee broods are
killed by the burrowing of the beetle larvae throughout the hive. Also,
the excrement of these hive beetles fouls the honey, reducing its
quality. Currently there are no pesticides registered for the control
of small hive beetles.
The Agency has authorized the use of coumaphos under section 18 of
FIFRA for the use of coumaphos impregnated in plastic strips to be hung
in beehives to control varroa mites and small hive beetles to 45
States. To date based on studies conducted by USDA, ARS, no chemical
other than coumaphos is available that provides reliable, effective
control of both varroa mites and/or small hive beetles. To date,
resistant strains of honey bees, biological control methods, and the
use of other natural products are not completely functional management
practices. The EPA did register formic acid during 1999. However it is
only registered for suppression of varroa mites and is not labeled for
control of small hive beetles. USDA, ARS has stressed that formic acid
alone is not a viable replacement for fluvalinate.
The Agency has concluded that not only would beekeepers be
adversely impacted if these emergency exemptions were not granted but
that the impact on much of agriculture in the United States could be
dire. That is, if coumaphos is not made available to control varroa
mites and small hive beetles beekeepers and honey producers in at least
45 states will suffer significant economic losses. Additionally, much
of agriculture in America will be adversely impacted. Few feral bee
colonies remain in the United States due to disease and insect pressure
(including that from varroa mites), increasing the American farmers
dependency on managed bees for pollination. Over 150 crops have been
identified that require bees for pollination. Based on figures
published by the National Agricultural Statistics Service of USDA the
estimated value of increased yield and quality achieved through
pollination by honey bees is 14.6 billion dollars per year.

[[Page 49929]]

In 1999, based on limited residue data available in which honey and
wax samples were collected from brood chambers, the Agency concluded
that there would be no reasonable expectation of residues of coumaphos
in commercial honey and processed beeswax used for food (taken from the
honey supers) provided that the coumaphos strips were used in brood
chambers when honey supers were not present (in accordance with the
section 18 authorization letter). Therefore, the section 18 use was
classified as a non-food use and no tolerances were established in
either honey or beeswax. However, based on additional information
submitted to the Agency in 2000 the non-food use classification is no
longer supportable and establishing tolerances for honey and beeswax is
necessary.
EPA has authorized under FIFRA section 18 the use of coumaphos in
beehives for control of varroa mites and small hive beetles in Alabama,
Arkansas, Arizona, California, Colorado, Connecticut, Delaware,
Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky,
Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri,
Minnesota, Mississippi, Montana, North Carolina, North Dakota,
Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania,
Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah,
Virginia, Vermont, Washington, Wisconsin, West Virginia, and Wyoming.
After having reviewed these submissions, EPA concurs that emergency
conditions exist.
As part of its assessment of this emergency exemption, EPA assessed
the potential risks presented by residues of coumaphos in or on honey
and beeswax. In doing so, EPA considered the safety standard in FFDCA
section 408(b)(2), and EPA decided that the necessary tolerances under
FFDCA section 408(l)(6) 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 these tolerances without notice and opportunity for public
comment as provided in section 408(l)(6). Although these tolerances
will expire and are revoked on December 31, 2002, under FFDCA section
408(l)(5), residues of the pesticide not in excess of the amounts
specified in the tolerances remaining in or on honey and beeswax after
that date will not be unlawful, provided the pesticide is applied in a
manner that was lawful under FIFRA, and the residues do not exceed
levels that were authorized by these tolerances at the time of that
application. EPA will take action to revoke these 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 tolerances are being approved under emergency
conditions, EPA has not made any decisions about whether coumaphos
meets EPA's registration requirements for use on honey and beeswax or
whether permanent tolerances for this use would be appropriate. Under
these circumstances, EPA does not believe that these tolerances serve
as a basis for registration of coumaphos by a State for special local
needs under FIFRA section 24(c). Nor do these tolerances serve as the
basis for any other State to use this pesticide in beehives under
section 18 of FIFRA without following all provisions of EPA's
regulations implementing section 18 as identified in 40 CFR part 166.
For additional information regarding the emergency exemption for
coumaphos, contact the Agency's Registration Division at the address
provided under FOR FURTHER INFORMATION CONTACT.

IV. Aggregate Risk Assessment and Determination of Safety

EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. For further discussion of the
regulatory requirements of section 408 and a complete description of
the risk assessment process, see the final rule on Bifenthrin Pesticide
Tolerances (62 FR 62961, November 26, 1997) (FRL-5754-7).
Consistent with 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 coumaphos
and to make a determination on aggregate exposure, consistent with
section 408(b)(2), for a time-limited tolerance for combined residues
of coumaphos (O,O-diethyl O-3- chloro-4-methyl-2-oxo-2H-1-benzopyran-7-
yl phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-
3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphate in or on honey
at 0.1 ppm and beeswax at 100 ppm. EPA's assessment of the dietary
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Endpoints

The dose at which no adverse effects are observed (the NOAEL) from
the toxicology study identified as appropriate for use in risk
assessment is used to estimate the toxicological endpoint. However, the
lowest dose at which adverse effects of concern are identified (the
LOAEL) is sometimes used for risk assessment if no NOAEL was achieved
in the toxicology study selected. An uncertainty factor (UF) is applied
to reflect 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. An UF of 100
is routinely used, 10X to account for interspecies differences and 10X
for intra species differences. For coumaphos an extra UF of 3 (for a
total UF of 300) was applied for acute dietary, short term inhalation,
and intermediate term inhalation assessments to account for the lack of
a NOAEL in the toxicology studies identified for use in these risk
assessments.
For dietary risk assessment (other than cancer) the Agency uses the
UF to calculate an acute or chronic reference dose (acute RfD or
chronic RfD) where the RfD is equal to the NOAEL divided by the
appropriate UF (RfD=NOAEL/UF). Where an additional safety factor is
retained due to concerns unique to the FQPA, this additional factor is
applied to the RfD by dividing the RfD by such additional factor. The
acute or chronic Population Adjusted Dose (aPAD or cPAD) is a
modification of the RfD to accommodate this type of FQPA Safety Factor.
For non-dietary risk assessments (other than cancer) the UF is used
to determine the level of concern (LOC). For example, when 100 is the
appropriate UF (10X to account for interspecies differences and 10X for
intraspecies differences) the LOC is 100. To estimate risk, a ratio of
the NOAEL to exposures (margin of exposure (MOE)=NOAEL/exposure) is
calculated and compared to the LOC.
The linear default risk methodology (Q*) is the primary method
currently used by the Agency to quantify carcinogenic risk. The Q*
approach assumes that any amount of exposure will lead to some degree
of cancer risk. A Q* is calculated and used to estimate risk which
represents a probability of occurrence of additional cancer cases
(e.g., risk is expressed as 1 x 10^-\6\ or one in a
million). Under certain specific circumstances, MOE calculations will
be used for the carcinogenic risk assessment. In this non-linear
approach, a ``point of departure'' is identified below which
carcinogenic effects are not expected. The point of departure is

[[Page 49930]]

typically a NOAEL based on an endpoint related to cancer effects though
it may be a different value derived from the dose response curve. To
estimate risk, a ratio of the point of departure to exposure
(MOEcancer = point of departure/exposures) is calculated.

Summary of Toxicological Dose and Endpoints for Coumaphos for Use in Human Risk Assessment
----------------------------------------------------------------------------------------------------------------
FQPA SF* and level of
Exposure scenario Dose used in risk concern for risk Study and toxicological
assessment, UF assessment effects
----------------------------------------------------------------------------------------------------------------
Acute Dietary females 13-50 years of LOAEL = 2.0 mg/kg/day; FQPA SF = 1; aPAD = Acute Oral
age UF = 300; Acute RfD = acute RfD; FQPA SF = Neurotoxicity study
0.007 mg/kg/day 0.007 mg/kg/day LOAEL = 2.0 mg/kg/day
based on plasma and
RBC cholinesterase
inhibition in both
males and females. A
NOAEL for
cholinesterase
inhibition was not
established.

Acute Dietary general population LOAEL = 2.0 mg/kg/day; FQPA SF = 1; aPAD = Acute Oral
including infants and children UF = 300; Acute RfD = acute RfD; FQPA SF = Neurotoxicity study
0.007 mg/kg/day 0.007 mg/kg/day LOAEL = 2.0 mg/kg/day
based on plasma and
RBC cholinesterase
inhibition in both
males and females. A
NOAEL for
cholinesterase
inhibition was not
established.

Chronic Dietary all populations NOAEL = 0.025 mg/kg/ FQPA SF = 1; cPAD = 1-Year Feeding study
day; UF = 100; Chronic chronic RfD; FQPA SF = in dog LOAEL = 0.77 mg/
RfD = 0.0003 mg/kg/day 0.0003 mg/kg/day kg/day based on
significant and
biologically relevant
depression of RBC ChE
and plasma ChE
activity levels.

Short-Term Dermal (1 to 7 days) dermal study NOAEL = LOC for MOE = 100 5-Day Dermal toxicity
(Residential) 5.0 mg/kg/day (dermal (Residential) study in rats LOAEL =
absorption rate = 10 mg/kg/day based on
100%) brain cholinesterase
inhibition in female
rats.

Intermediate-Term Dermal (1 week to dermal study NOAEL = LOC for MOE = 100 21-Day Dermal Study in
several months) (Residential) 0.5 mg/kg/day (dermal (Residential) the rat LOAEL = 1.1 mg/
absorption rate = kg/day based on RBC
100%) cholinesterase
inhibition in female
rats.

Long-Term Dermal (several months to None None None
lifetime) (Residential)

Short-Term Inhalation (1 to 7 days) Oral study LOAEL = 2.0 LOC for MOE = 300 Acute Neurotoxicity
(Residential) mg/kg/day (inhalation (Residential) Study in Rats LOAEL =
absorption rate = 100) 2.0 mg/kg/day based on
plasma and RBC ChE
inhibition in rats; no
NOAEL was established.

Intermediate-Term Inhalation (1 week Oral study LOAEL = 0.2 LOC for MOE = 300 13-Week Feeding study
to several months) (Residential) mg/kg/day (inhalation (Residential) in rats LOAEL = 0.2 mg/
absorption rate = kg/day based on RBC
100%) ChE inhibition in; no
NOAEL was established.

Long-Term Inhalation (several months None None None
to lifetime) (Residential)

Cancer (oral, dermal, inhalation) Classified as a Group E None None
chemical, ``not
likely'' to be
carcinogenic.
----------------------------------------------------------------------------------------------------------------
*The reference to the FQPA Safety Factor refers to any additional safety factor retained due to concerns unique
to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and feed uses. Coumaphos is an
acaricide currently registered for use on livestock animals for the
control of arthropod pests. Tolerances have been established (40 CFR
180.189) for the combined residues of coumaphos (O,O-diethyl O-3-
chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl phosphorothioate) and its
oxygen analog, coumaphoxon (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-
benzopyran-7-yl phosphate, in or on meat, fat, and meat byproducts of
cattle, goats, hogs, horses, poultry, and sheep, and in milk and eggs.
Tolerances are set at 1.0 ppm in livestock tissues, 0.5 ppm in milk-fat
residues, and 0.1 ppm in eggs. Although tolerances are still listed in
the most recent CFR (revised July 1, 1999) for sheep, goats, and
poultry (1.0 ppm) and eggs (0.1 ppm), the use of coumaphos on poultry
(eggs) has been canceled and the use of coumaphos on goat and sheep are
no longer supported by the technical registrant and will be deleted.
Therefore, these commodities are not included in the dietary risk
analysis. Risk assessments were conducted by EPA to assess dietary
exposures from coumaphos in food as follows:
i. Acute exposure. Acute dietary risk assessments are performed for
a food-use pesticide if a toxicological study has indicated the
possibility of an effect of concern occurring as a result of a one day
or single exposure. The Dietary Exposure Evaluation Model
(DEEM)

[[Page 49931]]

analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide Continuing Surveys of Food
Intake by Individuals (CSFII) and accumulated exposure to the chemical
for each commodity. The acute analysis for coumaphos is a highly
refined (Tier 3 Monte-Carlo) estimate of dietary exposure from residues
in food. The following assumptions were made for the acute exposure
assessments: use of anticipated residues information for livestock,
percent livestock treated information, monitoring data from the USDA
PDP program for livestock and monitoring data collected for honey
samples treated in 1999 and 2000 under the emergency exemptions from
Sioux Honey Association.
ii. Chronic exposure. In conducting this chronic dietary risk
assessment the Dietary Exposure Evaluation Model (DEEM)
analysis evaluated the individual food consumption as reported by
respondents in the USDA 1989-1992 nationwide CSFII and accumulated
exposure to the chemical for each commodity. The chronic analysis for
coumaphos is a refined estimate of dietary exposure from residues in
food. The following assumptions were made for the chronic exposure
assessments: use of anticipated residues information for livestock,
percent livestock treated information, monitoring data from the USDA
PDP program for livestock and monitoring data collected for honey
samples treated in 1999 and 2000 under the emergency exemptions from
Sioux Honey Association.
iii. Cancer. Coumaphos is classified as Group E (no evidence of
carcinogenicity in humans).
iv. Anticipated residue and percent crop treated information.
Section 408(b)(2)(E) authorizes EPA to use available data and
information on the anticipated residue levels of pesticide residues in
food and the actual levels of pesticide chemicals that have been
measured in food. If EPA relies on such information, EPA must require
that data be provided 5 years after the tolerance is established,
modified, or left in effect, demonstrating that the levels in food are
not above the levels anticipated. Following the initial data
submission, EPA is authorized to require similar data on a time frame
it deems appropriate. As required by section 408(b)(2)(E), EPA will
issue a data call-in for information relating to anticipated residues
to be submitted no later than 5 years from the date of issuance of this
tolerance.
Section 408(b)(2)(F) states that the Agency may use data on the
actual percent of food treated for assessing chronic dietary risk only
if the Agency can make the following findings: Condition 1, that the
data used are reliable and provide a valid basis to show what
percentage of the food derived from such crop is likely to contain such
pesticide residue; Condition 2, that the exposure estimate does not
underestimate exposure for any significant subpopulation group; and
Condition 3, if data are available on pesticide use and food
consumption in a particular area, the exposure estimate does not
understate exposure for the population in such area. In addition, the
Agency must provide for periodic evaluation of any estimates used. To
provide for the periodic evaluation of the estimate of percent crop
treated (PCT) as required by section 408(b)(2)(F), EPA may require
registrants to submit data on PCT.
The Agency used the following percent livestock treated (PLT)
information: 5% beef (and horse) including lean meat without removable
fat, beef fat, beef liver, beef byproducts, kidney; 1% hog including
meat, hog fat, hog liver, hog byproducts, and hog kidney; 100% veal
including lean meat without removable fat, veal fat, veal liver, veal
meat by-products, and veal kidney; and 4% milk. Anticipated residue
values (ARs) were calculated from field trial data for estimation of
both acute and chronic dietary exposure for all livestock commodities,
with the exception of milk. The residue values used for milk are from
the USDA's PDP 1997 and 1998 monitoring data which show no detectable
residues in milk out of 750 samples tested. Anticipated residues used
for honey were based on monitoring data provided by Sioux Honey
Association. These data represent raw honey samples which were likely
to be treated under Section 18 exemptions in 1999 and 2000. Only those
samples with detectable or quantifiable residues (limit of detection =
1 ppb) of coumaphos (parent) were included in the anticipated residue
calculations. Some samples were analyzed more than once. In those cases
the average value of the multiple analyses was used to calculate the
residue level for chronic exposure, whereas the highest value was
chosen for the acute analysis.
The Agency believes that the three conditions listed in Unit
IV.B.1.iv. of this preamble have been met. With respect to Condition 1,
PCT estimates are derived from Federal and private market survey data,
which are reliable and have a valid basis. EPA uses a weighted average
PCT for chronic dietary exposure estimates. This weighted average PCT
figure is derived by averaging State-level data for a period of up to
10 years, and weighting for the more robust and recent data. A weighted
average of the PCT reasonably represents a person's dietary exposure
over a lifetime, and is unlikely to underestimate exposure to an
individual because of the fact that pesticide use patterns (both
regionally and nationally) tend to change continuously over time, such
that an individual is unlikely to be exposed to more than the average
PCT over a lifetime. For acute dietary exposure estimates, EPA uses an
estimated maximum PCT. The exposure estimates resulting from this
approach reasonably represent the highest levels to which an individual
could be exposed, and are unlikely to underestimate an individual's
acute dietary exposure. The Agency is reasonably certain that the
percentage of the food treated is not likely to be an underestimation.
As to Conditions 2 and 3, regional consumption information and
consumption information for significant subpopulations is taken into
account through EPA's computer-based model for evaluating the exposure
of significant subpopulations including several regional groups. Use of
this consumption information in EPA's risk assessment process ensures
that EPA's exposure estimate does not understate exposure for any
significant subpopulation group and allows the Agency to be reasonably
certain that no regional population is exposed to residue levels higher
than those estimated by the Agency. Other than the data available
through national food consumption surveys, EPA does not have available
information on the regional consumption of food to which coumaphos may
be applied in a particular area.
2. Dietary exposure from drinking water. The Agency lacks
sufficient monitoring exposure data to complete a comprehensive dietary
exposure analysis and risk assessment for coumaphos in drinking water.
Because the Agency does not have comprehensive monitoring data,
drinking water concentration estimates are made by reliance on
simulation or modeling taking into account data on the physical
characteristics of coumaphos.
The Agency uses the Generic Estimated Environmental Concentration
(GENEEC) or the Pesticide Root Zone/Exposure Analysis Modeling System
(PRZM/EXAMS) to estimate pesticide concentrations in surface water and
SCI-GROW, which predicts pesticide concentrations in ground water. In
general, EPA will use GENEEC (a tier 1

[[Page 49932]]

model) before using PRZM/EXAMS (a tier 2 model) for a screening-level
assessment for surface water. The GENEEC model is a subset of the PRZM/
EXAMS model that uses a specific high-end runoff scenario for
pesticides. GENEEC incorporates a farm pond scenario, while PRZM/EXAMS
incorporate an index reservoir environment in place of the previous
pond scenario. The PRZM/EXAMS model includes a percent crop area factor
as an adjustment to account for the maximum percent crop coverage
within a watershed or drainage basin.
None of these models include consideration of the impact processing
(mixing, dilution, or treatment) of raw water for distribution as
drinking water would likely have on the removal of pesticides from the
source water. The primary use of these models by the Agency at this
stage is to provide a coarse screen for sorting out pesticides for
which it is highly unlikely that drinking water concentrations would
ever exceed human health levels of concern.
Since the models used are considered to be screening tools in the
risk assessment process, the Agency does not use estimated
environmental concentrations (EECs) from these models to quantify
drinking water exposure and risk as a %RfD or %PAD. Instead drinking
water levels of comparison (DWLOCs) are calculated and used as a point
of comparison against the model estimates of a pesticide's
concentration in water. DWLOCs are theoretical upper limits on a
pesticide's concentration in drinking water in light of total aggregate
exposure to a pesticide in food, and from residential uses. Since
DWLOCs address total aggregate exposure to coumaphos they are further
discussed in the aggregate risk sections below.
Based on the GENEEC and SCI-GROW models the estimated environmental
concentrations (EECs) of coumaphos in surface water and ground water,
respectively, for acute exposures are estimated to be 1.9 parts per
billion (ppb) for surface water and 0.17 ppb for ground water. The EECs
for chronic exposures are estimated to be 0.41 ppb for surface water
and 0.17 ppb for ground water. Note, in the Revised Risk Assessment for
Coumaphos, released by the Agency as published in the Federal Register
of April 26, 2000 (65 FR 24468) (FRL-6556-7), with the comment period
ending June 26, 2000, the estimated EECs for surface and ground water
are different than those reported above. Based on the available
environmental data, the Koc value for the parent coumaphos
is 3,994 to 11,422. In the Revised Risk Assessment for Coumaphos, in
absence of data on the degradate coumaphoxon, it was assumed that the
Koc value for coumaphoxon was 0.1. Therefore, the EECs
values represented an overly conservative exposure assessment. For this
risk assessment the Agency used a computer estimation program (EPI
version 3.04) to estimate a more realistic Koc value of 92.3
and water solubility value of 31.61 at 25 deg.C for coumaphoxon. Use of
these values accounts for the difference in estimated EECs.
Furthermore, Bayer Corporation recently provided preliminary results of
data conducted on coumaphoxon that indicate that the Koc
values for coumaphoxon are 1,897.78 and greater. Finally, the Agency
has recently received information that suggests that most of the
coumaphos residual resulting from dip use on livestock is collected and
transported to concrete-lined evaporation pits thereby negating any
potential for ground water contamination. The Agency is currently
verifying these practices. For these reasons the revised EECs are still
considered a very conservative exposure assessment.
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). Coumaphos is not
registered for use on any sites that would result in residential
exposure.
4. Cumulative exposure to substances with a common mechanism of
toxicity. In applying the safety standard in section 408(b)(2)(A), EPA
is required to consider, among other relevant factors, ``available
information concerning the cumulative effects of such residues and
other substances that have a common mechanism of toxicity.'' Coumaphos
is in a family of pesticides known as organophosphates. As documented
in EPA presentations to the FIFRA Scientific Advisory Panel, EPA has
concluded that organophosphates share a common mechanism of toxicity
and thus have a cumulative toxic effect (A Common Mechanism of Action:
The Organophosphate Pesticides, 11/2/98, USEPA). Based on this
conclusion EPA has been working toward preparing a cumulative risk
assessment on the organophosphate pesticides, including coumaphos, as
part of the tolerance reassessment program and has generally refused to
register new uses of organophosphates under FIFRA or establish new
tolerances for such pesticides under the FFDCA prior to completing this
cumulative assessment. EPA has considered the potential cumulative
effects of coumaphos. EPA has concluded the risks posed by granting
this tolerance are so small that they are effectively indistinguishable
from the overall aggregate risk of coumaphos, much less the overall
cumulative risk posed by the organophosphates. The dire need for this
use, combined with its infinitesimal risk, make it clear, that no
matter what the result of any cumulative risk assessment for the
organophosphates, it is very unlikely that this use would be proposed
for revocation.

C. Safety Factor for Infants and Children

1. In general. FFDCA section 408 provides that EPA shall apply an
additional tenfold 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 data base on toxicity and exposure
unless EPA determines that a different margin of safety will be safe
for infants and children. Margins of safety are incorporated into EPA
risk assessments either directly through use of a margin of exposure
(MOE) analysis or through using uncertainty (safety) factors in
calculating a dose level that poses no appreciable risk to humans.
2. Developmental toxicity studies. The developmental toxicity
studies in rats and rabbits showed no evidence of additional
sensitivity to young rats or rabbits following prenatal or postnatal
exposure to coumaphos and comparable NOAELs were established for adults
and offspring.
In a developmental toxicity study pregnant rats received oral doses
of coumaphos at 0, 1, 5 or 25 mg/kg/day during gestation days 6 through
15. For maternal toxicity, the NOAEL was 5 mg/kg/day and the LOAEL was
25 mg/kg/day based on clinical signs of cholinesterase inhibition. For
developmentaltoxicity, the NOAEL was 25 mg/kg/day (HDT); a LOAEL was
not established. There was no evidence of teratogenicity.
In a developmental toxicity study, pregnant rabbits were given
single oral dose of coumaphos at 0, 0.25, 2, or 18 mg/kg/day during
gestation days 7 through 19. For maternal toxicity, the NOAEL was 2 mg/
kg/day and the LOAEL was 18 mg/kg/day based on mortality (2/17) and
cholinergic signs. For developmental toxicity, the NOAEL was 18 mg/kg/
day (HDT); a LOAEL was not established. There was no evidence of
teratogenicity.
3. Reproductive toxicity study. In a 2-generation reproduction
study, rats were

[[Page 49933]]

fed diets containing coumaphos at 0, 0.07, 0.3, or 1.79 mg/kg/day in
males and 0, 0.08, 0.34 or 2.02 mg/kg/day in females, respectively.
There was no increased sensitivity to pups over the adults. For
parental/systemic toxicity, the NOAEL was 1.79 mg/kg/day, (HDT); a
LOAEL was not established. For reproductive toxicity, the NOAEL was
1.79 mg/kg/day; a LOAEL was not established.
4. Cholinesterase inhibition. Cholinesterase activity was not
measured in the adults and offspring in the developmental toxicity
studies. In the reproduction study, ChE activity was measured in adults
and pups. There was dose-related decreases in plasma and red blood cell
cholinesterase activity in dams at 0.34 and 2.02 mg/kg/day. Generally,
no differences were seen on day 47 and day 91 measurements. Brain
levels were biologically significantly inhibited in F0 and
F1 adult females at 2.02 mg/kg/day, and in F0
adult males at 1.79 mg/kg/day. In pups, no significant changes in red
blood cell or brain cholinesterase activity were seen on day 4, but on
day 21 changes were seen at 2.02 mg/kg/day. In F1 pups,
plasma and red blood cell ChE inhibition of 38-44% was seen, while in
F2 pups, only plasma was affected (31-44%). The only
significant brain inhibition in pups was an 8% decrease in
F1 females on day 21. The NOAEL was 0.3 for cholinesterase
inhibition in dams and in pups on day 21.
5. Neurotoxicity. In an acute delayed neurotoxicity study, no
delayed neurotoxicity was seen in hens given a single oral dose (via
gelatin capsule) of coumaphos at 50 mg/kg. There are sufficient data
available to adequately assess the potential for toxicity to young
animals following prenatal and/or postnatal exposure to coumaphos.
These include acceptable developmental toxicity studies in rats and
rabbits, as well as, a 2-generation reproduction studies in rats. In
addition, no treatment-related neuropathology was seen after acute and
subchronic exposure to rats. Additionally, there was no evidence of
abnormalities to the fetus to the fetal nervous system in the prenatal
and postnatal studies.
6. Prenatal and postnatal sensitivity. Prenatal developmental
toxicity studies in rats and rabbits provided no indication of
increased susceptibility of rat or rabbit fetuses to in utero exposure
to coumaphos. There was no indication of increased susceptibility in
the offspring as compared to parental animals in the 2-generation
reproduction study. In these studies, effects in the fetuses/offspring
were observed only at or above treatment levels which resulted in
evidence of parental toxicity.
7. Conclusion. Previously for coumaphos, the Agency recommended the
FQPA safety factor be reduced from 10x to 3x due to data gaps for the
acute and subchronic neurotoxicity studies. These data requirements
have been satisfied and therefore, the Agency has determined the FQPA
safety factor can be reduced to 1x. The decision to reduce the FQPA
Safety factor to 1x is based on the following:
The previous data gap for acute and subchronic neurotoxicity have
been satisfied. There is no indication of increased susceptibility of
rat or rabbits to coumaphos. In the developmental and reproduction
toxicity studies, effects in the fetuses/offspring were observed only
at or above treatment levels which resulted in evidence of parental
toxicity.

D. Aggregate Risks and Determination of Safety

To estimate total aggregate exposure to a pesticide from food,
drinking water, and residential uses, the Agency calculates DWLOCs
which are used as a point of comparison against the model estimates of
a pesticide's concentration in water (EECs). DWLOC values are not
regulatory standards for drinking water. DWLOCs are theoretical upper
limits on a pesticide's concentration in drinking water in light of
total aggregate exposure to a pesticide in food and residential uses.
In calculating a DWLOC, the Agency determines how much of the
acceptable exposure (i.e., the PAD) is available for exposure through
drinking water e.g., allowable chronic water exposure (mg/kg/day)=
cPAD--(average food+ chronic non-dietary, non-occupational exposure).
This allowable exposure through drinking water is used to calculate a
DWLOC.
A DWLOC will vary depending on the toxic endpoint, drinking water
consumption, and body weights. Default body weights and consumption
values as used by the USEPA Office of Water are used to calculate
DWLOCs: 2L/70 kg (adult male), 2L/60 kg (adult female), and 1L/10 kg
(child). Default body weights and drinking water consumption values
vary on an individual basis. This variation will be taken into account
in more refined screening-level and quantitative drinking water
exposure assessments. Different populations will have different DWLOCs.
Generally, a DWLOC is calculated for each type of risk assessment used:
acute, short-term, intermediate-term, chronic, and cancer.
When EECs for surface water and ground water are less than the
calculated DWLOCs, OPP concludes with reasonable certainty that
exposures to coumaphos in drinking water (when considered along with
other sources of exposure for which OPP has reliable data) would not
result in unacceptable levels of aggregate human health risk at this
time. Because OPP considers the aggregate risk resulting from multiple
exposure pathways associated with a pesticide's uses, levels of
comparison in drinking water may vary as those uses change. If new uses
are added in the future, OPP will reassess the potential impacts of
coumaphos on drinking water as a part of the aggregate risk assessment
process.
1. Acute risk. Using the exposure assumptions discussed in this
unit for acute exposure, the acute dietary exposure from food to
coumaphos at the 99.9^th percentile will occupy 8% of the
aPAD for the U.S. population, 4% of the aPAD for females 13 through 50
years old, 21% of the aPAD for all infants less than 1 year old, the
infant subpopulation at greatest exposure and 15% of the aPAD for
children 1-6 years old, the children subpopulation at greatest
exposure. In addition, despite the potential for acute dietary exposure
to coumaphos in drinking water, after calculating DWLOCs and comparing
them to conservative model estimated environmental concentrations of
coumaphos in surface and ground water. EPA does not expect the
aggregate exposure to exceed 100% of the aPAD.

Aggregate Risk Assessment for Acute Exposure to Coumaphos
--------------------------------------------------------------------------------------------------------------------------------------------------------
Surface water EEC Ground water EEC
Population subgroup aPAD (mg/kg) % aPAD (Food) (ppb) (ppb) Acute DWLOC (ppb)
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.007 mg/kg/day 8 % 1.9 0.17 220
Females, 13-50 years old 0.007 4 % 1.9 0.17 200
All Infants, less than 1 year old 0.007 mg/kg/day 2 1% 1.9 0.17 54

[[Page 49934]]

Children, 1-6 years old 0.007 mg/kg/day 15% 1.9 0.17 59
--------------------------------------------------------------------------------------------------------------------------------------------------------

Comparing the risk estimates for the addition of honey and beeswax
to those discussed in the risk assessment recently released for public
comment under Phase 5 of the reregistration process for the registered
uses on livestock, the Agency concludes that there is no incremental
increase in dietary exposure or risk when the residues in honey are
added to those from the registered uses on livestock. The slight
changes reported in some cases (e.g., increase in acute exposure for
children 7-12 years old) are likely to be within the noise or
uncertainty of the analyses. The fact that the calculated exposure
actually decreases in a few cases when honey is added to livestock is
further indication of this.

Comparison of Aggregate Risk for Acute Exposure to Coumaphos Without and With Honey
--------------------------------------------------------------------------------------------------------------------------------------------------------
Acute exposure without Acute exposure with Percent acute PAD Percent acute PAD with
Population subgroup honey (mg/kg/day) honey (mg/kg/day) without honey honey
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.000528 0.000524 7.55% 7.49%
Females, 13-50 years old 0.000247 0.000247 3.52% 3.53%
All Infants, less than 1 year old 0.001494 0.001493 21.34% 21.33%
Children, 1-6 years old 0.001069 0.001069 15.27% 15.27%
Children, 7-12 years old 0.000520 0.000524 7.42% 7.49%
--------------------------------------------------------------------------------------------------------------------------------------------------------

Within the operating capability of the model, the Agency concludes
that the above results show there is no incremental increase in dietary
exposure or risk when the residues in honey are added to those from the
registered uses on livestock.
2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that exposure to coumaphos
from food will utilize 6% of the cPAD for the U.S. population, 4% of
the cPAD for all infants less than 1 year old, and 14 % of the cPAD for
children 1-6 years old, the children subpopulation at greatest
exposure. There are no residential uses for coumaphos that result in
chronic residential exposure to coumaphos. In addition, despite the
potential for chronic dietary exposure to coumaphos in drinking water,
after calculating the DWLOCs and comparing them to conservative model
estimated environmental concentrations of coumaphos in surface and
ground water. EPA does not expect the aggregate exposure to exceed 100%
of the cPAD.

Aggregate Risk Assessment for Chronic (Non-Cancer) Exposure to Coumaphos
----------------------------------------------------------------------------------------------------------------
Surface Ground
Population subgroup cPAD mg/kg/ % cPAD water EEC water EEC Chronic
day (Food) (ppb) (ppb) DWLOC (ppb)
----------------------------------------------------------------------------------------------------------------
U.S. Population 0.0003 6% 0.41 0.17 10
All Infants, less than 1 year old 0.0003 4% 0.41 0.17 3
Children, 1-6 years old 0.0003 14% 0.41 0.17 9
----------------------------------------------------------------------------------------------------------------

Comparing the risk estimates for the addition of honey and beeswax
to those discussed in the risk assessment recently released for public
comment under Phase 5 of the reregistration process for the registered
uses on livestock, the Agency concludes that there is no incremental
increase in dietary exposure or risk when the residues in honey are
added to those from the registered uses on livestock. The slight
changes reported in some cases are likely to be within the noise or
uncertainty of the analyses. The fact that the calculated exposure
actually decreases in a few cases when honey is added to livestock is
further indication of this.

Comparison of Aggregate Risk for Chronic Exposure to Coumaphos Without and With Honey
--------------------------------------------------------------------------------------------------------------------------------------------------------
Chronic exposure
Population Subgroup without honey (mg/kg/ Chronic exposure with % Chronic PAD without % Chronic PAD with
day) honey (mg/kg/day) honey honey
--------------------------------------------------------------------------------------------------------------------------------------------------------
U.S. Population 0.000013 0.000013 5.3% 5.4%
Females, 13-50 years old 0.000009 0.000009 3.7% 3.7%
All Infants, less than 1 year old 0.000011 0.000011 4.3% 4.3%
Children, 1-6 years old 0.000033 0.000033 13.2% 13.2%
Children, 7-12 years old 0.000022 0.000022 8.9% 8.9%
--------------------------------------------------------------------------------------------------------------------------------------------------------

Within the operating capability of the model, the Agency concludes
that the above results show there is no incremental increase in dietary
exposure or risk when the residues in

[[Page 49935]]

honey are added to those from the registered uses on livestock.
3. Short-term risk. Short-term aggregate exposure takes into
account residential exposure plus chronic exposure to food and water
(considered to be a background exposure level). Coumaphos is not
registered for use on any sites that would result in residential
exposure. Therefore, the aggregate risk is the sum of the risk from
food and water, which were previously addressed.
4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account non-dietary, non-occupational exposure plus chronic
exposure to food and water (considered to be a background exposure
level). Coumaphos is not registered for use on any sites that would
result in residential exposure. Therefore, the aggregate risk is the
sum of the risk from food and water, which were previously addressed.
5. Aggregate cancer risk for U.S. population. Coumaphos is
classified as Group E (no evidence of carcinogenicity in humans).
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, and to infants and children from aggregate
exposure to coumaphos residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Adequate enforcement methodology (LC/MS/MS) is available to enforce
the tolerance expression. The method for honey is Bayer Method 150.803
and for beeswax is Bayer Method 150.804. Either method may be requested
from: Calvin Furlow, PRRIB, IRSD (7502C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW,
Washington, DC 20460; telephone number: (703) 305-5229; e-mail address:
furlow.calvin@epa.gov.

B. International Residue Limits

There are no Codex tolerances for coumaphos, therefore there are no
harmonization issues with this tolerance.

VI. Conclusion

Therefore, the tolerances are established for combined residues of
coumaphos, (O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl
phosphorothioate) and its oxygen analog, coumaphoxon (O,O-diethyl O-3-
chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl) phosphate, in or on honey
at 0.1 ppm and beeswax at 100 ppm.

VII. Objections and Hearing Requests

Under section 408(g) of the FFDCA, as amended by the 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. Although the procedures in those
regulations require some modification to reflect the amendments made to
the FFDCA by the FQPA of 1996, EPA will continue to use those
procedures, with appropriate adjustments, until the necessary
modifications can be made. The new section 408(g) provides essentially
the same process for persons to ``object'' to a regulation for an
exemption from the requirement of a tolerance issued by EPA under new
section 408(d), as was provided in the old FFDCA sections 408 and 409.
However, the period for filing objections is now 60 days, rather than
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this
regulation in accordance with the instructions provided in this unit
and in 40 CFR part 178. To ensure proper receipt by EPA, you must
identify docket control number OPP-301039 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 October
16, 2000.
1. Filing the request. Your objection must specify the specific
provisions in the regulation that you object to, and the grounds for
the objections (40 CFR 178.25). If a hearing is requested, the
objections must include a statement of the factual issues(s) on which a
hearing is requested, the requestor's contentions on such issues, and a
summary of any evidence relied upon by the objector (40 CFR 178.27).
Information submitted in connection with an objection or hearing
request may be claimed confidential by marking any part or all of that
information as CBI. Information so marked will not be disclosed except
in accordance with procedures set forth in 40 CFR part 2. A copy of the
information that does not contain CBI must be submitted for inclusion
in the public record. Information not marked confidential may be
disclosed publicly by EPA without prior notice.
Mail your written request to: Office of the Hearing Clerk (1900),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460. You may also deliver your request to the Office
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW.,
Washington, DC 20460. The Office of the Hearing Clerk is open from 8
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
2. Tolerance fee payment. If you file an objection or request a
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must
mail the fee to: EPA Headquarters Accounting Operations Branch, Office
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please
identify the fee submission by labeling it ``Tolerance Petition Fees.''
EPA is authorized to waive any fee requirement ``when in the
judgement of the Administrator such a waiver or refund is equitable and
not contrary to the purpose of this subsection.'' For additional
information regarding the waiver of these fees, you may contact James
Tompkins by phone at (703) 305-5697, by e-mail at tompkins.jim@epa.gov,
or by mailing a request for information to Mr. Tompkins at Registration
Division (7505C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
If you would like to request a waiver of the tolerance objection
fees, you must mail your request for such a waiver to: James Hollins,
Information Resources and Services Division (7502C), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
3. Copies for the Docket. In addition to filing an objection or
hearing request with the Hearing Clerk as described in Unit VII.A., you
should also send a copy of your request to the PIRIB for its inclusion
in the official record that is described in Unit I.B.2. Mail your
copies, identified by the docket control number OPP-301039, to: Public
Information and Records Integrity Branch, Information Resources and
Services Division (7502C), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
In person or by courier, bring a copy to the location of the PIRIB
described in Unit I.B.2. You may also send an electronic copy of your
request via e-mail to: opp-docket@epa.gov. Please use an ASCII file
format and avoid the use of special characters and any form of
encryption. Copies of electronic objections and hearing requests will
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII
file format. Do not

[[Page 49936]]

include any CBI in your electronic copy. You may also submit an
electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

A request for a hearing will be granted if the Administrator
determines that the material submitted shows the following: There is a
genuine and substantial issue of fact; there is a reasonable
possibility that available evidence identified by the requestor would,
if established resolve one or more of such issues in favor of the
requestor, taking into account uncontested claims or facts to the
contrary; and resolution of the factual issues(s) in the manner sought
by the requestor would be adequate to justify the action requested (40
CFR 178.32).

VIII. Regulatory Assessment Requirements

This final rule establishes time limited tolerances under FFDCA
section 408. 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).
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., or 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). Nor does it require any prior consultation
as specified by Executive Order 13084, entitled Consultation and
Coordination with Indian Tribal Governments (63 FR 27655, May 19,
1998); special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994);
or require OMB review or any Agency action under Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997). 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). Since
tolerances and exemptions that are established on the basis of a FIFRA
section 18 petition under FFDCA section 408, such as the tolerances in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply. In addition, the Agency has determined that this
action will not have a substantial direct effect on States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government, as specified in Executive Order 13132, entitled Federalism
(64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by State and local officials in the development of regulatory policies
that have federalism implications.'' ``Policies that have federalism
implications'' is defined in the Executive Order to include regulations
that have ``substantial direct effects on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government.'' This final rule directly regulates growers, food
processors, food handlers and food retailers, not States. This action
does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4).

IX. Submission to Congress and the Comptroller General

The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
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: August 3, 2000.
James Jones,
Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

2. Section 180.189 is amended by adding text to paragraph (b) to
read as follows:

Sec. 180.189 Coumaphos; tolerances for residues.

* * * * *
(b) Section 18 emergency exemptions. Time-limited tolerances are
established for the combined residues of the insecticide coumaphos
(O,O-diethyl O-3-chloro-4-methyl-2-oxo-2H-1-benzopyran-7-yl
phosphorothioate) and its oxygen analog, (O,O-diethyl O-3-chloro-4-
methyl-2-oxo-2H-1-benzopyran-7-yl phosphate in connection with use of
the pesticide under section 18 emergency exemptions granted by the EPA.
The tolerances will expire and are revoked on the dates specified in
the following table.

------------------------------------------------------------------------
Expiration/
Commodity Parts per revocation
million date
------------------------------------------------------------------------
Beeswax 100 ppm 12/31/02
Honey 0.1 ppm 12/31/02
------------------------------------------------------------------------

* * * * *

[FR Doc. 00-20732 Filed 8-15-00; 8:45 am]
BILLING CODE 6560-50-S

Coumaphos; Pesticide Tolerances for Emergency Exemptions

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