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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28878 Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations 

be amended by establishing tolerances 

for residues of the fungicide 

famoxadone, 3-anilino-5-methyl-5-(4- 

phenoxyphenyl)-1,3-oxazolidine-2,4- 

dione, in or on grape (east of the rocky 

mountains) at 2.5 parts per million 

(ppm); hop, dried cone at 60 ppm; and 

caneberry at 11 ppm. These notices 

referenced a summary of the petitions 

prepared by Dupont, the registrant, 

which is available to the public in the 

docket, http://www.regulations.gov. A 

comment was received from a private 

citizen on the notice of filing for 

famoxadone on caneberry. EPA’s 

response to comment is discussed in 

Unit IV.C. 

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 FFDCA section 

408(b)(2)(D), 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 tolerances for 

residues of famoxadone grape (regional 

registration) at 2.5 ppm; hop, dried cone 

at 80 ppm; and caneberry subgroup 13A 

at 10 ppm on EPA’s assessment of 

exposures and risks associated with 

establishing the tolerances follow. 

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 famoxadone as well as the no 

observed adverse effect level (NOAEL) 

and the lowest observed adverse effect 

level (LOAEL) from the toxicity studies 

are discussed in the final rule published 

in the Federal Register at http:// 

www.epa.gov/EPA–PEST/2003/July/ 

Day–02/p16736.htm. 

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 no adverse effects are observed 

(the NOAEL) in the toxicology study 

identified as appropriate for use in risk 

assessment. However, if a NOAEL 

cannot be determined, the lowest dose 

at which adverse effects of concern are 

identified (the LOAEL) 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 adjusted 

dose (cPAD). The aPAD and cPAD are 

calculated by dividing the LOC by all 

applicable uncertainty/safety factors. 

Short-, 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-threshold risks, 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 uses 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 famoxadone can be found 

at www.regulations.gov in the Human 

Health Risk Assessment for 

Famoxadone to Support Tolerances for 

Residues in/on Grapes, Hops, and 

Caneberry, Crop Subgroup 13A, pages 

10–11 in Docket ID EPA–HQ–OPP–

2006–0332. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to famoxadone, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing famoxadone tolerances in (40 

CFR 180.587). EPA assessed dietary 

exposures from famoxadone 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 1–day or single 

exposure. No such effects were 

identified in the toxicological studies 

for famoxadone. Therefore, a 

quantitative acute dietary exposure 

assessment was not performed. 

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 used Dietary 

Exposure Evaluation Model (DEEMTM) 

default processing factors and 

anticipated residues (ARs) calculated 

from field trial data including the 

highest average field trial (HAFT) level 

for hop and caneberry, and existing ARs 

for grape commodities. Exposure 

estimates were further refined with 

percent crop treated (PCT) data for 

several registered commodities. 

iii. Cancer. EPA has classified 

famoxadone as a ‘‘not likely’’ human 

carcinogen. Therefore, a cancer dietary 

exposure analysis was not performed. 

iv. Anticipated residue and PCT 

information. Section 408(b)(2)(E) of 

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 CallIns as are required by section 

408(b)(2)(E) of FFDCA and authorized 

under section 408(f)(1) of FFDCA. Data 

will be required to be submitted no later 

than 5 years from the date of issuance 

of this tolerance. 


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Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations 28879 

Section 408(b)(2)(F) of FFDCA states 

that the Agency may use data on the 

actual percent of food treated for 

assessing chronic dietary risk only if: 

a. The data used are reliable and 

provide a valid basis to show what 

percentage of the food derived from 

such crop is likely to contain such 

pesticide residue; 

b. The exposure estimate does not 

underestimate exposure for any 

significant subpopulation group; and 

c. Data are available on pesticide use 

and food consumption in a particular 

area, the exposure estimate does not 

understate exposure for the population 

in such area. In addition, the Agency 

must provide for periodic evaluation of 

any estimates used. To provide for the 

periodic evaluation of the estimate of 

PCT as required by section 408(b)(2)(F) 

of FFDCA, EPA may require registrants 

to submit data on PCT. 

The Agency used PCT information as 

follows: 

Tomato at 10%; Cucumber, Pepper, 

Potato, Pumpkin at 5%; Squash and 

Watermelon at 1%EPA uses an average 

PCT for chronic dietary risk analysis. 

The average PCT figure for each existing 

use is derived by combining available 

federal, state, and private market survey 

data for that use, averaging by year, 

averaging across all years, and rounding 

up to the nearest multiple of five 

percent except for those situations in 

which the average PCT is less than one. 

In those cases <1% is used as the 

average and <2.5% is used as the 

maximum. EPA uses a maximum PCT 

for acute dietary risk analysis. The 

maximum PCT figure is the single 

maximum value reported overall from 

available federal, state, and private 

market survey data on the existing use, 

across all years, and rounded up to the 

nearest multiple of five percent. In most 

cases, EPA uses available data from 

United States Department of 

Agriculture/National Agricultural 

Statistics Service (USDA/NASS), 

Proprietary Market Surveys, and the 

National Center for Food and 

Agriculture Policy (NCFAP) for the most 

recent 6 years. 

The Agency believes that the three 

conditions listed have been met. With 

respect to Condition 1, PCT estimates 

are derived from Federal and private 

market survey data, which are reliable 

and have a valid basis. The Agency is 

reasonably certain that the percentage of 

the food treated is not likely to be an 

underestimation. As to Conditions 2 and 

3, regional consumption information 

and consumption information for 

significant subpopulations is taken into 

account through EPA’s computer-based 

model for evaluating the exposure of 

significant subpopulations including 

several regional groups. Use of this 

consumption information in EPA’s risk 

assessment process ensures that EPA’s 

exposure estimate does not understate 

exposure for any significant 

subpopulation group and allows the 

Agency to be reasonably certain that no 

regional population is exposed to 

residue levels higher than those 

estimated by the Agency. Other than the 

data available through national food 

consumption surveys, EPA does not 

have available information on the 

regional consumption of food to which 

famoxadone may be applied in a 

particular area. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

famoxadone 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 

famoxadone. 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 assessment was based on the 

registered potato use (highest 

application rate, 0.1875 lbs ai/acre, with 

6 applications at 5 day intervals). The 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/ 

EXAMS) Model was used to estimate 

surface water concentrations, and 

Screening Concentrations in 

Groundwater (SCI-GROW) Model was 

used to estimate ground water 

concentrations. The model values 

generally represent upper-bound 

estimates of the concentrations that 

might be found in surface water and 

ground water resulting from the use of 

famoxadone. 

Based on the PRZM/EXAMS and SCIGROW models, the estimated 

environmental concentrations (EECs) of 

famoxadone for chronic exposures are 

estimated to be 0.47 ppb for surface 

water and 0.23 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 0.47 ppb 

was used to access 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). 

Famoxadone 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

famoxadone and any other substances 

and famoxadone does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that famoxadone has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

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 is no quantitative or qualitative 

evidence of increased susceptibility of 

rat and rabbit fetuses to in utero 

exposure in developmental studies. 

There is no quantitative or qualitative 

evidence of increased susceptibility of 

rat offspring in the multi-generation 

reproduction study. 


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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 

famoxadone is complete. 

ii. There is no indication that 

famoxadone is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional uncertainty factors to account 

for neurotoxicity. 

iii. There is no evidence that 

famoxadone results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

Although the food exposure assessment 

was slightly refined, it is based in 

reliable data 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 

famoxadone. 

E. Aggregate Risks and Determination of 

Safety 

Safety is assessed for acute and 

chronic risks by comparing aggregate 

exposure to the pesticide to the 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-, 

intermediate, 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. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption and drinking water. There 

was no acute dietary endpoint selected. 

Therefore, famoxdane is not expected to 

pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to famoxadone from food 

and water will utilize 65% of the cPAD 

for children 1-2 years old, the 

subpopulation group with the greatest 

exposure. There are no residential uses 

for famoxadone that result in chronic 

residential exposure to famoxadone. 

3. Short and intermediate-term risks. 

Short and Intermediate-term aggregate 

exposures takes into account residential 

exposure plus chronic exposure to food 

and water (considered to be a 

background exposure level). 

Famoxadone is not registered for use 

on any sites that would result in 

residential exposure. Therefore, the 

aggregate risk is the sum of the risk from 

food and water, which do not exceed 

the Agency’s level of concern. 

4. Aggregate cancer risk for U.S. 

population. EPA has classified 

famoxadone as a ‘‘not likely’’ human 

carcinogen. Therefore, famoxdane 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 famoxadone 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method AMR 3705–95; 

gas chromatography with nitrogen/ 

phosphorus detector (GC/NPD) for 

plants was developed for data gathering 

and enforcement purposes to quantitate 

famoxadone. The method has 

undergone a successful independent 

laboratory validation (ILV) and Agency 

petition method validation (PMV). 

Therefore, adequate enforcement 

methodology is available to enforce this 

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 established CODEX 

maximum residue limits (MRLs) for 

famoxadone. 

C. Response to Comments 

One comment was received by a 

private citizen. The commenter argued 

that cancer rates in the United States are 

too high and no new pesticides should 

be approved until the causes of the 

increased cancers are found. 

Additionally, the commenter urged that 

EPA should test famoxdane in 

combination with the thousands of 

other chemicals to which humans are 

exposed. Famoxdane has been 

examined in the required 

carcinogenicity studies and EPA 

concluded that it is not likely to be 

carcinogenic to humans. This was 

discussed in a prior rulemaking 

published in the Federal Register at 

http://www.epa.gov/EPA-PEST/2003/ 

July/Day-02/p16736.htm. EPA does not 

require the testing of pesticides in 

combination with other chemicals but 

does consider available data bearing on 

whether a pesticide shares a common 

toxicity with other substances that 

could result in cumulative effects. For 

specific information regarding EPA’s 

approach to the use of common 

mechanism of toxicity to evaluate the 

cumulative effects of chemicals, please 

refer to EPA’s website at http:// 

www.epa.gov/pesticides/cumulative to 

see policy statements. 

V. Conclusion 

The proposed tolerance for hop, dried 

cone was requested at 60 ppm. The 

residue data from the hop field trials 

indicate that residues of famoxadone 

ranged from 14.70 ppm to 46.85 ppm in/ 

on dried hops harvested 7-8 days after 

the last of six applications at a total rate 

of ~1.50 lb ai/A. The submitted data are 

adequate pending label revision to 

reflect the parameters of field trial data. 

The Agency recommends the following 

label revisions: apply a maximum single 

foliar application rate of 0.25 lb ai/A, 

with a 6-8 day RTI, a maximum seasonal 

rate of ~1.50 lb ai/A, and a 7–day PHI. 

Statistical analysis of the data show that 

a tolerance level of 80 ppm will be 

appropriate for hops. 

The proposed tolerance for caneberry, 

subgroup 13-A was requested at 11 

ppm. The results from these trials show 

that famoxadone residues ranged from 

0.40 ppm to 6.7 ppm on/in treated 

caneberry when the test substance was 

applied at the proposed seasonal 

application rate of 1.125 lb ai/A using 

a 0–day PHI. Caneberry were stored 

frozen for a maximum of 181 days at 

–21°9C. Submitted storage stability 

studies indicate that famoxadone 

residues are stable on caneberry for up 

to 216 days. A residue decline study 

was not conducted by the applicant. 

Statistical analysis of the data show that 

a tolerance level of 10 ppm will be 

appropriate for caneberry, subgroup 13- 

A. 

Therefore, the tolerances are 

established for residues of famoxadone, 

3-anilino-5-methyl-5-(4- 

phenoxyphenyl)-1,3-oxazolidine-2,4- 

dione), in or on grape (regional 

registration) at 2.5 ppm; hop, dried cone 

at 80 ppm; and caneberry, Subgroup 

13A at 10 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 


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Federal Register / Vol. 72, No. 99 / Wednesday, May 23, 2007 / Rules and Regulations 28881 

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, 

Acting 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 180.587 is amended by 

revising the section heading; by 

alphabetically adding caneberry, 

Subgroup 13A and hop, dried cone to 

the table in paragraph (a) and removing 

grape from the table in paragraph (a); 

and adding text to paragraph (c) to read 

as follows: 

§ 180.587 Famoxadone; tolerance for 

residues. 

(a) * * * 

Commodity Parts per million 

Caneberry, Subgroup 

13A .............................. 10 

*****

Hop, dried cone .............. 80 

*****

1There are no U.S. registrations as of May 

15,2003. 

* * * * * 

(c) Tolerances with a regional 

registrations. Tolerances with a regional 

registration as defined in Sec. 180.1(n) 

are established for the residues of the 

fungicide famoxadone, 3-anilino-5- 

methyl-5-(4-phenoxyphenyl)-1,3- 

oxazolidine-2,4-dione) in or on the raw 

agricultural commodities: 

Commodity Parts per million 

Grape .............................. 2.5 

* * * * * 

[FR Doc. E7–9823 Filed 5–22–07; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0586; FRL–8126–6] 

Propanil, Phenmedipham, Triallate, 

and MCPA; Tolerance Actions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking certain 

tolerances for the herbicides propanil, 

triallate, and MCPA. EPA is modifying 

certain tolerances for the herbicides 

propanil, phenmedipham, triallate, and 

MCPA. In addition, EPA is establishing 

tolerances for the herbicides propanil, 

phenmedipham, triallate, and MCPA. 

The regulatory actions in this document 

are part of the Agency’s reregistration 

program under the Federal Food, Drug, 

and Cosmetic Act (FFDCA) section 

408(q), as amended by the Food Quality 

Protection Act (FQPA) of 1996. 

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–2006–0586. 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 


cprice-sewell on PROD1PC71 with RULES