Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations 28871 

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 14, 2007. 

Janet L. Andersen, 

Director, Biopesticides and Pollution 

Prevention 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 180.1206 is amended by 

designating the existing text as 

paragraph (a) and by adding paragraph 

(b) to read as follows: 

§ 180.1206 Aspergillus flavus AF36 on 

pistachio; exemption from the requirement 

of a tolerance. 

(a) * * *

(b) Apergillus flavus AF36 is 

temporarily exempt from the 

requirement of a tolerance on pistachio 

when used in accordance with the 

Experimental Use Permit 71693-EUP-1. 

This temporary exemption from 

tolerance will expire on May 14, 2010. 

[FR Doc. E7–9729 Filed 5–22–07; 8:45 am] 

BILLING CODE 6560–50–S 

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. 

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 http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

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 

http://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 http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the 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 


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28872 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations 

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: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460-0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S-4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305-5805. 

II. 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, http:// 

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 

§180.189(b) for honey and honeycomb 

that are no longer needed. The tolerance 

deletions under §180.189(b) are timelimited tolerances established under 

section 18 emergency exemptions that 

are superceded by the establishment of 

general tolerances for coumaphos under 

§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 (http://www.epa.gov/ 

oppsrrd1/REDs/0018.pdf), the 

Reregistration Eligibility Decision 

Addendum and FQPA Tolerance 

Reassessment Progress Report (TRED) 

for coumaphos (http://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 (http:// 

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 (http://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 


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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 http:// 

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 


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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 http://www.epa.gov/ 

oppefed1/models/water/index.htm. 

The generic expected environmental 

concentration (GENEEC) and screening 

concentration in groundwater (SCIGROW) 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 nonoccupational, 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 nonoccupational 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 http:// 

www.epa.gov/pesticides/cumulative/ 

pra_op_methods.htm. In June 2002, the 

Agency released its Revised OP CRA, 

available at http://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 http:// 

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 (http://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 (DEEMFCIDTM, 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. 


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Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations 28875 

A description of the program and 

residue data for recent years can be 

found online (http://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 (http://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. Shortterm, 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. 


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28876 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations 

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. 

■ 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 

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: 

§ 180.189 Coumaphos; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

*****

Honey ................................................................................................................................................................................... 0.15 

Honeycomb 45.0 

*****


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Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations 28877 

(b) Section 18 emergency exemptions. 

[Reserved] 

* * * * * 

[FR Doc. E7–9813 Filed 5–22–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0332; FRL–8128–6] 

Famoxadone; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of famoxadone in 

or on grape, hop, and caneberry, 

Subgroup 13A. Interregional Research 

Project (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–2006–0332. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

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 

http://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: 

Shaja R. Brothers, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–3194; e-mail address: 

brothers.shaja@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 http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e–CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the 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–2006–0332 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 

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–2006–0332, by one of the 

following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on–

line instructions for submitting 

comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Tolerance 

In the Federal Register of May 10, 

2006 (71 FR 27247) (FRL–8067–5) and 

November 22, 2006 (71 FR 67572) (FRL–

8101–9), EPA issued notices pursuant to 

section 408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of 

pesticide petitions PP 5E7001 (grape 

and hop), and PP 6E7099 (caneberry) by 

the IR–4, 500 College Road East, Suite 

201 W, Princeton, NJ 08540. The 

petitions requested that 40 CFR 180.587 


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