[Federal Register Volume 65, Number 159 (Wednesday, August 16, 2000)]
[Rules and Regulations]
[Pages 49927-49936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20732]


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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: 
[email protected].

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 99.9th 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: 
[email protected].

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 [email protected], 
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: [email protected]. 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