Coumaphos; Pesticide Tolerance, 28871-28877 [E7-9813]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 72, Number 99 (Wednesday, May 23, 2007)]
[Rules and Regulations]
[Pages 28871-28877]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-9813]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2006-0820; FRL-8131-4]


Coumaphos; Pesticide Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of 
coumaphos in or on honey and honeycomb. Interregional Research Project 
4 (IR-4) requested these tolerances under the Federal Food, 
Drug, and Cosmetic Act (FFDCA).

DATES: This regulation is effective May 23, 2007. Objections and 
requests for hearings must be received on or before July 23, 2007, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2006-0820. To access the 
electronic docket, go to https://www.regulations.gov, select ``Advanced 
Search,'' then ``Docket Search.'' Insert the docket ID number where 
indicated and select the ``Submit'' button. Follow the instructions on 
the regulations.gov web site to view the docket index or access 
available documents. All documents in the docket are listed in the 
docket index available in regulations.gov. Although listed in the 
index, some information is not publicly available, e.g., Confidential 
Business Information (CBI) or other information whose disclosure is 
restricted by statute. Certain other material, such as copyrighted 
material, is not placed on the Internet and will be publicly available 
only in hard copy form. Publicly available docket materials are 
available in the electronic docket at https://www.regulations.gov, or,if 
only available in hard copy, at the OPP Regulatory Public Docket in Rm. 
S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr. Arlington, 
VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday 
through Friday, excluding legal holidays. The Docket Facility telephone 
number is (703) 305-5805.

FOR FURTHER INFORMATION CONTACT: Barbara Madden, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 305-6463; 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 entities may include, but are not limited to those 
engaged in the following activities:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.
    This listing is not intended to be exhaustive, but rather to 
provide a guide for readers regarding entities likely to be affected by 
this action. Other types of entities not listed in this unit could also 
be affected. The North American Industrial Classification System 
(NAICS) codes have been provided to assist you and others in 
determining whether this action might apply to certain entities. If you 
have any questions regarding the applicability of this action to a 
particular entity, consult the person listed under FOR FURTHER 
INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing an electronic copy of this Federal 
Register document through the electronic docket at https://
www.regulations.gov, you may access this Federal Register document 
electronically through the EPA Internet under the ``Federal Register'' 
listings at https://www.epa.gov/fedrgstr. You may also access a 
frequently updated electronic version of EPA's tolerance regulations at 
40 CFR part 180 through the Government Printing Office's pilot e-CFR 
site at https://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of the FFDCA, any person may file an objection 
to any aspect of this regulation and may also request a hearing on 
those objections. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2006-0820 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 as required by 40 CFR part 178 on or 
before July 23, 2007.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in

[[Page 28872]]

ADDRESSES. Information not marked confidential pursuant to 40 CFR part 
2 may be disclosed publicly by EPA without prior notice. Submit this 
copy, identified by docket ID number EPA-HQ-OPP-2006-0820, by one of 
the followingmethods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket's normal hours of operation (8:30 a.m. to 4 
p.m., Monday through Friday, excluding legal holidays). Special 
arrangements should be made for deliveries of boxed information. The 
Docket Facility telephone number is (703) 305-5805.

II. Petition for Tolerance

    In the Federal Register of October 18, 2006 (71 FR 61465) (FRL-
8097-9), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 
2E6504) by Interregional Research Project 4 (IR-4), Rutgers, 
The State University of New Jersey, 500 College Road East, Suite 201 W, 
Princeton, NJ 08540. The petition requested that 40 CFR 180.189 be 
amended by establishing a tolerance for 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 or on honey at 0.10 
parts per million (ppm) and honeycomb at 100 ppm. That notice 
referenced a summary of the petition prepared by Bayer CropScience, the 
registrant, which is available to the public in the docket, https://
www.regulations.gov. Comments were received on the notice of filing. 
EPA's response to these comments is discussed in Unit IV.C.
    Based upon review of the data supporting the petition, EPA has 
determined tolerance levels for honey and honeycomb should be modified. 
The reason for these changes is explained in Unit V. EPA is also 
deleting the established tolerances in Sec. 180.189(b) for honey and 
honeycomb that are no longer needed. The tolerance deletions under 
Sec. 180.189(b) are time-limited tolerances established under section 
18 emergency exemptions that are superceded by the establishment of 
general tolerances for coumaphos under Sec. 180.189(a).

III. Aggregate Risk Assessment and Determination of Safety

    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) of the FFDCA defines ``safe'' to mean that ``there is 
a reasonable certainty that no harm will result from aggregate exposure 
to the pesticide chemical residue, including all anticipated dietary 
exposures and all other exposures for which there is reliable 
information.'' This includes exposure through drinking water and in 
residential settings, but does not include occupational exposure. 
Section 408(b)(2)(C) of the FFDCA requires EPA to give special 
consideration to exposure of infants and children to the pesticide 
chemical residue in establishing a tolerance and to ``ensure that there 
is a reasonable certainty that no harm will result to infants and 
children from aggregate exposure to the pesticide chemical residue. . . 
.'' These provisions were added to the FFDCA by the Food Quality 
Protection Act (FQPA) of 1996.
    Consistent with section 408(b)(2)(D) of the FFDCA, and the factors 
specified in section 408(b)(2)(D), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for the petitioned-for tolerance 
for residues of 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) on 
honey at 0.15 ppm and honeycomb at 45 ppm. EPA's assessment of 
exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by coumaphos as well as the NOAEL and the 
LOAEL from the toxicity studies can be found in the Reregistration 
Eligibility Decision (RED) for coumaphos (https://www.epa.gov/oppsrrd1/
REDs/0018.pdf), the Reregistration Eligibility Decision Addendum and 
FQPA Tolerance Reassessment Progress Report (TRED) for coumaphos 
(https://www.epa.gov/oppsrrd1/REDs/0018tred.pdf) and at 
www.regulations.gov in document Coumaphos: Human Health Risk Assessment 
for Proposed Use on Honey and Honeycomb page 11 in Docket ID EPA-HQ-
OPP-2006-0820.
    The mammalian toxicology database for coumaphos is complete. Acute 
toxicity studies in rats and rabbits; an acute delayed neurotoxicity 
study in hens; subchronic oral and dermal studies in rats; chronic/
carcinogenicity studies in rats, mice, and dogs; developmental toxicity 
studies in rats and rabbits; a 2-generation study in rats; mutagenicity 
studies; and a metabolism study were discussed and considered in the 
Reregistration Eligibility Decision (RED) for coumaphos (https://
www.epa.gov/oppsrrd1/REDs/0018.pdf). Acute and subchronic neurotoxicity 
studies in rats were received subsequent to the RED and were considered 
in the RED Addendum and FQPA Tolerance Reassessment Progress Report 
(TRED) for coumaphos (https://www.epa.gov/oppsrrd1/REDs/0018tred.pdf). 
Subsequent to the TRED, a developmental neurotoxicity study and a 
comparative cholinesterase study in rats were received; these studies 
are discussed in detail at www.regulations.gov in document Coumaphos: 
Human Health Risk Assessment for Proposed Use on Honey and Honeycomb at 
page 11 in Docket ID EPA-HQ-OPP-2006-0820.
    The acute toxicity of coumaphos is high via the oral route of 
exposure (Category I), moderate via the inhalation route (Category II), 
and slight via the dermal route (Category III). Coumaphos is not a 
dermal sensitizer or a dermal irritant.
    Coumaphos, an organophosphate insecticide, primarily affects the 
nervous system through cholinesterase (ChE) inhibition. Females are 
consistently more sensitive to the cholinergic effects than males. In 
the acute oral toxicity studies, female rats are approximately 17 times 
more sensitive to the toxic and lethal effects of coumaphos compared to 
male rats. In a single dose oral study, female rats had ChE inhibition 
and cholinergic symptoms at much lower doses than male rats. In a 
short-term (5 days) dermal toxicity study, brain ChE inhibition was the 
most sensitive

[[Page 28873]]

indication of the toxic effects of coumaphos dermal treatment. In 
subchronic and chronic studies in rats, the magnitude of ChE inhibition 
in red blood cell and plasma and brain was also more pronounced in 
females, compared to males. Coumaphos does not cause delayed 
neuropathy. In chronic studies, systemic effects other than cholinergic 
toxicity include decreases in body weight gain.
    There was no evidence of malformations or decreases in the number 
of pups and/or litter or surviving offspring in any of the 
developmental toxicity or reproduction studies. In developmental 
toxicity studies in rats and rabbits, no developmental toxicity was 
observed, while clinical signs of ChE toxicity were seen in the 
maternal animals. In a 2-generation reproduction study, ChE inhibition 
was noted in both parents and offspring, with parents more susceptible. 
Reproductive toxicity was not observed in this study.
    The developmental neurotoxicity study showed no increased 
susceptibility of the young. The maternal ChE activity was inhibited at 
both the mid and high does. Consistent with the other mammalian 
toxicity studies, female pups were more sensitive to cholinergic 
effects than males; at the high dose, female plasma, erythrocyte, and 
brain ChE activities were inhibited 27%, 33%, and 8%, respectively, but 
only plasma ChE activity was significantly inhibited (30%) at this dose 
in males. In the comparative ChE study increased quantitative 
susceptibility of the offspring was observed in that ChE inhibition was 
seen at a lower dose in neonatal rats, compared to young adult rats. 
The relative sensitivities to ChE inhibition at peak inhibition by 
coumaphos were measured in neonatal and young adult rats. This 
comparative ChE study does demonstrate increased quantitative 
susceptibility of the offspring. However, the degree of concern for 
this comparative ChE study is low because the effects are well 
characterized and there are clear no observed adverse effect levels 
(NOAELs) and lowest observed adverse effect levels (LOAELs) for both 
neonatal and adult animals. Furthermore, there are no residual 
uncertainties for prenatal and/or postnatal toxicity for the 
comparative ChE study because the endpoint of concern is the one used 
for the acute dietary exposure risk assessment and a more protective 
endpoint (based on long term-exposure) is used for chronic dietary 
exposure risk assessment.
    Coumaphos is not carcinogenic and is classified as a Group E 
chemical, indicating that it is ``Not Likely'' to be carcinogenic in 
humans via relevant routes of exposure. This classification is based on 
adequate studies in two animal species. No evidence of mutagenicity was 
seen in any study.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, the toxicological level of concern (LOC) is derived 
from the highest dose at which the NOAEL in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which the LOAEL of 
concern are identified is sometimes used for risk assessment. 
Uncertainty/safety factors (UF) are used in conjunction with the LOC to 
take into account uncertainties inherent in the extrapolation from 
laboratory animal data to humans and in the variations in sensitivity 
among members of the human population as well as other unknowns. Safety 
is assessed for acute and chronic risks by comparing aggregate exposure 
to the pesticide to the acute population adjusted dose (aPAD) and 
chronic population (cPAD) adjusted dose. The aPAD and cPAD are 
calculated by dividing the LOC by all applicable uncertainty/safety 
factors. Short-term, intermediate, and long-term risks are evaluated by 
comparing aggregate exposure to the LOC to ensure that the margin of 
exposure (MOE) called for by the product of all applicable uncertainty/
safety factors is not exceeded.
    For non-threhold risk, the Agency assumes that any amount of 
exposure will lead to some degree of risk and estimates risk in terms 
of the probability of occurrence of additional adverse cases. 
Generally, cancer risks are considered non-threshold. For more 
information on the general principles EPA used in risk characterization 
and a complete description of the risk assessment process, see https://
www.epa.gov/fedrgstr/EPA-PEST/1997/November/Day-26/p30948.htm.
    A summary of the toxicological endpoints for coumpahos used for 
human risk assessment can be found at www.regulations.gov in document 
Coumaphos: Human Health Risk Assessment for Proposed Use on Honey and 
Honeycomb page 15 in Docket ID EPA-HQ-OPP-2006-0820.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to coumaphos, EPA considered exposure under the petitioned-for 
tolerances as well as all existing coumaphos tolerances in (40 CFR 
180.189). EPA assessed dietary exposures from coumaphos and coumaphos-
oxon in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and 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
    In estimating acute dietary exposure, EPA used food consumption 
information from the United States Department of Agriculture's (USDA) 
1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by 
Individuals (CSFII). As to residue levels in food, EPA relied upon 
anticipated residues incorporating 2002 (USDA) Pesticide Data Program 
(PDP) monitoring data for beef and 2004 PDP monitoring data for milk. 
Field trial data were used for honey to support the proposed use 
pattern. The dietary exposure assessment assumes 100% crop treated for 
all commodities.
    ii. Chronic exposure. In conducting the chronic dietary exposure 
assessment EPA used the food consumption data from the USDA 1994-1996 
and 1998 Nationwide Continuing Surveys of Food Intake by Individuals 
(CSFII). As to residue levels in food, EPA relied upon anticipated 
residues incorporating 2002 USDA PDP monitoring data for beef and 2004 
PDP monitoring data for milk. Field trial data were used for honey to 
support the proposed use pattern. The dietary exposure assessment 
assumes 100% crop treated for all commodities.
    iii. Cancer. Coumaphos is not carcinogenic and is classified as a 
Group E chemical, indicating that it is ``Not Likely'' to be 
carcinogenic in humans via relevant routes of exposure. Therefore, the 
Agency concluded that coumaphos is not expected to pose a carcinogenic 
risk and quantification of cancer risk is not required.
    iv. Anticipated residue information. Section 408(b)(2)(E) of the 
FFDCA authorizes EPA to use available data and information on the 
anticipated residue levels of pesticide residues in food and the actual 
levels of pesticide residues that have been measured in food. If EPA 
relies on such information, EPA must pursuant to section 408(f)(1) 
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. For the present action, 
EPA will issue such data call-ins as are required by section 
408(b)(2)(E) and authorized under section 408(f)(1) of the FFDCA. Data 
will be required to be

[[Page 28874]]

submitted no later than 5 years from the date of issuance of this 
tolerance.
    2. Dietary exposure from drinking water. The Agency lacks 
sufficient monitoring 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 environmental fate characteristics of 
coumaphos. Further information regarding EPA drinking water models used 
in pesticide exposure assessment can be found at https://www.epa.gov/
oppefed1/models/water/index.htm.
    The generic expected environmental concentration (GENEEC) and 
screening concentration in groundwater (SCI-GROW) screening models were 
used to estimate surface water and ground water concentrations of 
coumaphos and its oxygen analog, coumaphoxon. This degradate is 
considered in the drinking water assessment, as it was in the 
assessment for consumption of food (honey and livestock commodities). 
Based on the GENEEC and SCI-GROW models, the estimated environmental 
concentrations (EECs) of coumaphos and its oxygen analog, coumaphoxon 
for acute exposures are estimated to be 1.86 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.
    Modeled estimates of drinking water concentrations were directly 
entered into the dietary exposure model. For acute dietary risk 
assessment, the water concentration value of 1.86 ppb was used to 
assess the contribution to drinking water. For chronic dietary risk 
assessment, the water concentration of value 0.41 ppb was used to 
assess the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).
     Coumaphos is not registered for use on any sites that would result 
in residential exposure.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of the FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    FQPA (1996) stipulates that when determining the safety of a 
pesticide chemical, the EPA shall consider, among other things, 
available information concerning the cumulative effects on human health 
that may result from dietary, residential, or other non-occupational 
exposure to the pesticide chemical and other substances that have a 
common mechanism of toxicity. The reason for consideration of other 
substances is due to the possibility that low-level exposures to 
multiple chemical substances that cause a common toxic effect by a 
common mechanism could lead to the same adverse health effect as would 
a higher level of exposure to any of the substances individually. A 
person exposed to a pesticide at a level that is considered safe may, 
in fact, experience harm if that person is also exposed to other 
substances that cause a common toxic effect by a mechanism common with 
that of the subject pesticide, even if the individual exposure levels 
to the other substances are also considered safe.
    The organophosphate pesticides (OPs) were established as the first 
common mechanism group by EPA in 1999, based on their shared ability to 
bind to and phosphorylate the enzyme acetylcholinesterase in both the 
central (brain) and peripheral nervous systems. Coumaphos is an OP 
pesticide. In December 2001, the Agency issued the ``Preliminary OP 
Cumulative Risk Assessment'', available at https://www.epa.gov/
pesticides/cumulative/pra_op_methods.htm. In June 2002, the Agency 
released its Revised OP CRA, available at https://www.epa.gov/
pesticides/cumulative/rra-op/, which included the cumulative risk due 
to the OPs from exposures in food, drinking water, and residential 
uses. In August 2006, the Agency issued an update to the 2002 Revised 
OP CRA document, which emphasized changes, modifications, and 
amendments. With the 2006 update, available at https://www.epa.gov/
pesticides/cumulative/2006-op/index.htm, the Agency has developed a 
highly refined and complex cumulative risk assessment for the OPs that 
represents the state of the science regarding existing hazard and 
exposure data and the models and approaches used. Based upon the 
results from the 2006 update, the Agency concluded that the results of 
the OP cumulative risk assessment support a reasonable certainty of no 
harm finding.
    In both the 2002 revised OP CRA, as well as the 2006 update, the 
cumulative dietary risk associated with the use of OP pesticides on 
food crops was assessed using residue monitoring data collected by the 
USDA PDP and dietary consumption data collected by USDA's Survey of 
Food Intakes by Individuals (CSFII). Both assessments relied primarily 
on the PDP for residue data; the 2006 update added PDP data collected 
in 2002-2004 to the 1994-2001 data used in the 2002 Revised Assessment. 
The PDP has been collecting pesticide residue data since 1991, 
primarily for purposes of estimating dietary exposure. The program 
focuses on high-consumption foods for children and reflects foods 
typically available throughout the year. A complete description of the 
PDP and all data through 2004 are available online (https://
www.ams.usda.gov/science/pdp). No PDP data on honey currently exist 
that could have been used in a cumulative assessment. OP residues in 
honey were not included in the PDP data base, in part because honey is 
a low-consumption food. A quantitative estimate of honey consumption 
over a single day was obtained for the general U.S. population and 
subpopulations using the Dietary Exposure Evaluation Model (DEEM-
FCIDTM, Version 2.03), which uses food consumption data from 
the USDA's CSFII from 1994-1996 and 1998. Consumption estimates at the 
99.9th percentile of exposure range from 21 grams of honey/
day in all infants (<1 year) to 96 grams/day in adults 50 + years, the 
population subgroup who reported the greatest amount of honey consumed. 
Estimates of honey consumption for all other subpopulations, including 
children 1-2, 3-5, and 6-12 years; youth 13-19 years; females 13-49 
years; and adults 20-49 years are within this range.
    Although PDP data on coumaphos data in honey is not available, 
monitoring for coumaphos in honey is conducted under the Food and Drug 
Administration's (FDA's) Center for Food Safety and Applied Nutrition 
(CFSAN) Surveillance Monitoring Program. This monitoring program is 
designed primarily for enforcement of EPA pesticide tolerances on 
imported foods and domestic foods shipped in interstate commerce. In 
this monitoring program, domestic samples are generally collected close 
to the point of production in the distribution system. Import samples 
are collected at the point of entry into U.S commerce. The emphasis in 
sample collection is on the agricultural commodity, which is analyzed 
as the unwashed, whole (unpeeled), raw commodity. Processed foods are 
also included in the program.

[[Page 28875]]

A description of the program and residue data for recent years can be 
found online (https://vm.cfsan.fda.gov/~lrd/pestadd.html). Because the 
emphasis of this program is not on dietary exposure, it was used in the 
2006 cumulative assessment mostly as a semi-quantitative check on the 
potential for residues and as support for data from other sources. Data 
are available from 1996-2003. Although the Agency has granted emergency 
exemptions, starting in 1999, such that the coumaphos strips assessed 
in this document have been and continue to be used on beehives in 40-46 
states (https://www.epa.gov/opprd001/section18), the FDA has detected 
coumaphos in honey only once, in 2003, at levels lower than the level 
of quantification. Thus, FDA data indicates that there is a low 
expectation of meaningful coumaphos residues in honey.
    EPA does not believe that inclusion of anticipated coumaphos 
residues in honey in the OP CRA will significantly modify the 
calculated risk. This conclusion is based on three factors. First, 
honey is a low consumption food, and, thus, even if honey contained 
quantifiable levels of OPs, it would be unlikely to significantly alter 
the OP CRA. Second, available monitoring data indicates that, despite 
widespread use of coumaphos, residues of coumaphos in honey as consumed 
are exceedingly low, if present at all. Finally, a prior risk 
assessment for coumaphos indicated that aggregate risk from coumaphos 
was essentially unchanged when honey containing levels of coumaphos 
residues found in field trials was added to the coumaphos risk 
assessment, August 16, 2000 (65 FR 49927) (FRL-6738-3). In the current 
assessment, no discernible difference in exposure was observed when 
coumaphos residues in honey and beeswax were or were not included in an 
aggregate assessment (personal correspondence, S. Piper, January 1, 
2007). If coumaphos exposure from honey is insignificant in comparison 
to exposure to coumaphos from other uses of the chemical, it 
necessarily is insignificant in comparison to exposure to the more than 
30 other OPs. For these reasons, EPA concludes that the establishment 
of a coumaphos honey tolerance will not raise a concern regarding 
cumulative OP exposure.

D. Safety Factor for Infants and Children

    1. In general. Section 408 of FFDCA provides that EPA shall apply 
an additional (``10X'') 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 based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor. In applying this provision, EPA either retains the default 
value of 10X when reliable data do not support the choice of a 
different factor, or, if reliable data are available, EPA uses a 
different additional FQPA safety factor value based on the use of 
traditional uncertainty/safety factors and/or special FQPA safety 
factors, as appropriate.
    2. Prenatal and postnatal sensitivity. There was no evidence of 
increased qualitative or quantitative susceptibility of the offspring 
in the developmental, reproduction, or developmental neurotoxicity 
studies. Increased quantitative susceptibility of the offspring was 
observed in the comparative ChE study in that ChE inhibition was seen 
at a lower dose in neonatal rats, compared to young adult rats. The 
degree of concern for this comparative ChE study is low because the 
effects are well characterized and there are clear NOAELs and LOAELs 
for both neonatal and adult animals. Furthermore, there are no residual 
uncertainties for pre- and/or postnatal toxicity for the comparative 
ChE study because the endpoint of concern is the one used for the acute 
dietary exposure risk assessment and a more protective endpoint (based 
on long-term exposure) is used for chronic dietary exposure risk 
assessment.
    3. Conclusion. EPA has determined that reliable data show that it 
would be safe for infants and children to reduce the FQPA safety factor 
to 1X. That decision is based on the following findings:
    i. The toxicity database for coumaphos is complete.
    ii. As discussed in Unit III.D.2., there are no residual 
uncertainties regarding prenatal or postnatal toxicity or increased 
sensitivity of the young.
    iii. There are no residual uncertainties identified in the exposure 
data bases. The dietary food exposure assessments were performed based 
on 100% crop treated and using reliable data (USDA PDP data for meat 
and milk and field trial data for honey) and will not underestimate the 
exposure and risk. Conservative ground water and surface water modeling 
estimates were used. These assessments will not underestimate the 
exposure and risks posed by coumaphos.

E. Aggregate Risks and Determination of Safety

    Safety is assessed for acute and chronic risks by comparing 
aggregate exposure to the pesticide aPAD and cPAD. The aPAD and cPAD 
are calculated by dividing the LOC by all applicable uncertainty/safety 
factors. For linear cancer risks, EPA calculates the probability of 
additional cancer cases given aggregate exposure. Short-term, 
intermediate-term, and long-term risks are evaluated by comparing 
aggregate exposure to the LOC to ensure that the MOE called for by the 
product of all applicable uncertainty/safety factors is not exceeded.
    1. Acute risk. Using the exposure assumptions discussed in this 
unit for acute exposure, the acute dietary exposure from food and water 
to coumaphos will occupy 15% of the aPAD for the U.S. population and 
38% of the aPAD for all infants (< 1 year), the most highly exposed 
population subgroup.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that exposure to coumaphos 
from food and water will utilize 6% of cPAD for the U.S. population and 
13% of the cPAD for all infants (< 1 year), the most highly exposed 
population subgroup. There are no residential uses for coumaphos that 
result in chronic residential exposure to coumaphos.
    3. Short-term and Intermediate-term risk. Short-term and 
intermediate 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.
    4. Aggregate cancer risk for U.S. population. Coumaphos is not 
carcinogenic and is classified as a Group E chemical, indicating that 
it is ``Not Likely'' to be carcinogenic in humans via relevant routes 
of exposure. This classification is based on adequate studies in two 
animal species. Coumaphos is not expected to pose a cancer risk.
    5. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to coumaphos residues.

[[Page 28876]]

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology liquid chromatography/mass 
spectroscopy/ mass spectroscopy (LC/MS/MS) is available to enforce the 
tolerance expression. The method may be requested from: Chief, 
Analytical Chemistry Branch, Environmental Science Center, 701 Mapes 
Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail 
address: residuemethods@epa.gov.

B. International Residue Limits

    There are no CODEX, Canadian, or Mexican maximum residue limits 
(MRLs) for residues of coumaphos in honey or honeycomb. Therefore, 
harmonization with international tolerances is not an issue for this 
action.

C. Response to Comments

    Several comments were received from a private citizen objecting to 
establishment of tolerances. The Agency has received similar comments 
from this commenter on numerous previous occasions. Refer to Federal 
Register June 30, 2005 (70 FR 37686) (FRL-7718-3), January 7, 2005 (70 
FR 1354) (FRL-7691-4) and, October 29, 2004 (69 FR 63096) (FRL-7681-9) 
for the Agency's response to these objections.

V. Conclusion

    Based upon review of the residue field trial data supporting the 
petition, EPA has determined tolerance levels for honey and honeycomb 
should be modified and tolerances levels should be 0.15 ppm for honey 
and 45 ppm for honeycomb.
    Therefore, tolerance are established for residues of 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) on honey at 0.15 ppm and 
honeycomb at 45 ppm.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA in response to a petition submitted to the Agency. The Office of 
Management and Budget (OMB) has exempted these types of actions from 
review under Executive Order 12866, entitled Regulatory Planning and 
Review (58 FR 51735, October 4, 1993). Because this rule has been 
exempted from review under Executive Order 12866, this rule is not 
subject to Executive Order 13211, Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, 
May 22, 2001) or Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997). This final rule does not contain any information collections 
subject to OMB approval under the Paperwork Reduction Act (PRA), 44 
U.S.C. 3501 et seq., nor does it require any special considerations 
under Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under section 408(d) of FFDCA, such as the tolerance in 
this final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.) do not apply.
    This final rule directly regulates growers, food processors, food 
handlers and food retailers, not States or tribes, nor does this action 
alter the relationships or distribution of power and responsibilities 
established by Congress in the preemption provisions of section 
408(n)(4) of FFDCA. As such, the Agency has determined that this action 
will not have a substantial direct effect on States or tribal 
governments, on the relationship between the national government and 
the States or tribal governments, or on the distribution of power and 
responsibilities among the various levels of government or between the 
Federal Government and Indian tribes. Thus, the Agency has determined 
that Executive Order 13132, entitled Federalism (64 FR 43255, August 
10, 1999) and Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000) do not apply to this rule. In addition, This rule does not impose 
any enforceable duty or contain any unfunded mandate as described under 
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 
104-4).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act of 1995 (NTTAA), Pub. L. 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. EPA will submit a report 
containing this rule and other required information to the U.S. Senate, 
the U.S. House of Representatives, and the Comptroller General of the 
United States prior to publication of this final rule in the Federal 
Register. This final rule is not a ``major rule'' as defined by 5 
U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: May 15, 2007.
Daniel J. Rosenblatt,
Director, Registration Division, Office of Pesticide Programs.

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

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

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


0
2. Section 180.189 is amended by alphabetically adding commodities to 
the table in paragraph (a), and in paragraph (b), the text and table 
are removed and the paragraph is reserved to read as follows:


Sec.  180.189  Coumaphos; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                   Commodity                        Parts per million
------------------------------------------------------------------------
                                * * * * *
Honey..........................................                     0.15
------------------------------------------------------------------------
Honeycomb                                                           45.0
                                * * * * *
------------------------------------------------------------------------


[[Page 28877]]

    (b) Section 18 emergency exemptions. [Reserved]
* * * * *
[FR Doc. E7-9813 Filed 5-22-07; 8:45 am]
BILLING CODE 6560-50-S