Federal Register / Vol. 73, No. 159 / Friday, August 15, 2008 / Rules and Regulations 47841 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1065; FRL–8375–4] 

Forchlorfenuron; Permanent and TimeLimited Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

permanent tolerance for residues of 

forchlorfenuron in or on bushberry 

subgroup 13–07B requested by the IR-4 

Project Headquarters, 500 College Road 

East, Suite 201 W, Princeton, NJ 08540. 

Time-limited tolerances are also being 

established under this regulation in 

support of experimental use permit 

71049-EUP-4 for residues of 

forchlorfenuron in or on almond, 

cherry, fig, pear, pistachio, plum/prune 

requested by KIM-C1, LLC c/o Siemer 

and Associates, Inc. 135 W. Shaw, Suite 

102, Fresno, CA 93704. The timelimited tolerances expire on December 

31, 2011. IR-4 and KIM-C1, LLC 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

August 15, 2008. Objections and 

requests for hearings must be received 

on or before October 14, 2008, 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 dockets 

for this action under docket 

identification (ID) numbers EPA–HQ–

OPP–2007–0627 and EPA–HQ–OPP–

2007–1065. 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 

website 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: 

Tawanda Maignan, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 308–8050; e-mail address: 

maignan.tawanda@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). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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 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–2007–1065 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 October 14, 2008. 

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–2007–1065, 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 October 24, 

2007 (72 FR 205) (FRL–8150–8) and of 

February 13, 2008 (73 FR 30) (FRL–

8351–5), EPA issued notices pursuant to 

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

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

pesticide petition (PP 7E7228) by the IR4 Project Headquarters, 500 College 

Road East, Suite 201 W, Princeton, NJ 

08540 and pesticide petition (PP 

7F7246) by KIM-C1, LLC c/o Siemer and 


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47842 Federal Register / Vol. 73, No. 159 / Friday, August 15, 2008 / Rules and Regulations 

Associates, Inc. 135 W. Shaw, Suite 102, 

Fresno, CA 93704, respectively. The 

petitions requested that 40 CFR 180.569 

be amended by establishing permanent 

tolerances and time-limited tolerances 

for residues of the plant growth 

regulator forchlorfenuron, in or on 

bushberry subgroup 13B at 0.01 parts 

per million (ppm) (PP 7E8228) and 

almond, cherry, fig, pear, pistachio, 

plum/prune at 0.01 ppm (PP 7F7246), 

respectively. Those notices referenced a 

summary of the petitions prepared by 

the registrants, Valent U.S.A. 

Corporation and KIM-C1, LLC, 

respectively which is available to the 

public in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filings. 

Based upon review of the data 

supporting the petitions, EPA has 

revised certain proposed tolerance 

levels and corrected commodity 

definitions as follow: 

The Agency determined that adequate 

data are available to support 

establishing a tolerance for the 

bushberry subgroup 13–07B. IR-4 

petitioned for a tolerance for bushberry 

subgroup 13B as well as individual 

tolerances on aronia berry, buffalo 

currant, Chilean guava, European 

barberry, highbush cranberry, 

honeysuckle, jostaberry, juneberry, 

lingonberry, native currant, salal, and 

sea buckthorn (PP 7E7228). In the 

Federal Register of December 7, 2007 

(72 FR 69150) (FRL–8340–6), EPA 

issued a final rule that revised the crop 

grouping regulations. As part of this 

action, EPA expanded and revised 

berries group 13. Changes to crop group 

13 (berries) included adding new 

commodities, revising existing 

subgroups and creating new subgroups 

(including a bushberry subgroup 13–

07B consisting of the commodities 

requested in PP 7E7228 and cultivars, 

varieties, and/or hybrids of these). 

EPA indicated in the December 7, 

2007 final rule as well as the earlier May 

23, 2007 proposed rule (72 FR 28920) 

(FRL–8126–6) that, for existing petitions 

for which a notice of filing had been 

published, the Agency would attempt to 

conform these petitions to the rule. 

Therefore, consistent with this rule, 

EPA is establishing a tolerance for the 

bushberry subgroup 13–07B. Bushberry 

subgroup 13–07B consists of the berries 

for which tolerances were requested in 

PP 7E7228. 

EPA concludes it is reasonable to 

revise the petitioned-for tolerances so 

that they agree with the recent crop 

grouping revisions because: 

• Although the subgroup includes 

several new commodities, these 

commodities were proposed as 

individual tolerances and are closely 

related minor crops which contribute 

little to overall dietary or aggregate 

exposure and risk. 

• Forchlorfenuron exposure from 

these added commodities was 

considered when EPA conducted the 

dietary and aggregate risk assessments 

supporting this action. 

• The representative commodities for 

the revised subgroup has not changed. 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of 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 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 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. . . .’’

Consistent with section 408(b)(2)(D) 

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, 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 

permanent tolerances for residues of 

forchlorfenuron on bushberry subgroup 

13–07B at 0.01 ppm and time-limited 

tolerances for residues of 

forchlorfenuron on almond, cherry, fig, 

pear, pistachio, plum/prune at 0.01 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

tolerances 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. 

Forchlorfenuron is not acutely toxic 

via the oral, dermal, and inhalation 

routes. Dose-related effects noted in the 

dog following subchronic and chronic 

exposure were generally limited to 

decreased body weight and body-weight 

gain. In the rat, the only organ that 

appeared to be affected was the kidney, 

which showed suppurative 

inflammation, suppurative 

pyelonephritis, non-suppurative 

interstitial nephritis, and cortical cysts 

following chronic exposure. 

Developmental toxicity (decreased fetal 

body weight) was observed in the rat 

only at a maternally-toxic dose. 

Forchlorfenuron did not induce any 

signs of reproductive toxicity or 

neurotoxic potential. The 

developmental toxicity studies in rats 

and rabbits, as well as the reproductive 

toxicity study in rats, did not 

demonstrate any prenatal or postnatal 

sensitivity. There was no evidence of 

neurotoxicity in any of the submitted 

studies. Forchlorfenuron is classified as 

not likely to be a human carcinogen and 

there is no concern for mutagenicity. 

There was no evidence of endocrine 

disruption in the forchlorfenuron 

database. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by forchlorfenuron as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in document 

Forchlorfenuron: Human Health Risk 

Assessment for Proposed Uses on the 

Bushberry Subgroup 13 B and to 

Support a Requested Experimental Use 

Permit on almonds, sweet cherries, figs, 

pears, pistachios and plums/prunes, in 

docket ID number EPA–HQ–OPP–2007–

1065. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

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) or a Benchmark Dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD to take into account 


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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 dietary risks by comparing 

aggregate food and water 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 POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the Level of Concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. 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/

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for forchlorfenuron used for 

human risk assessment is shown in 

Table 1 of this unit. 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FORCHLORFENURON FOR USE IN HUMAN RISK

ASSESSMENT

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Acute dietary (all populations) No appropriate endpoint attributable to a single exposure (dose) was identified from oral toxicity studies, including the developmental studies. 

Chronic dietary 

(All populations) 

NOAEL= 7 mg/kg/day 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

Chronic RfD = 0.07 mg/kg/day Chronic oral toxicity study- rat 

LOAEL = 93 mg/kg/day based on 

decreased body weight/bodyweight gain/food consumption, 

and kidney toxicity (suppurative 

inflammation in males; nonsuppurative interstitial nephritis in females) 

Dermal short-term 

(1 to 30 days) 

(oral) NOAEL = 100 mg/kg/day 

(Dermal absorption rate = 100% 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Developmental toxicity study - rabbit 

LOAEL = 125 mg/kg/day based on 

body-weight loss during dosing 

period in the range-finding study 

Dermal intermediate-term 

(1 to 6 months) 

(Oral) NOAEL= 87 mg/kg/day 

(Dermal absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Chronic oral toxicity study - dog 

LOAEL = 195 mg/kg/day based on 

decreased body weight/bodyweight gain/food consumption 

Dermal long-term 

(>6 months) 

(Oral) NOAEL = 7 mg/kg/day 

(Dermal absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Chronic oral toxicity study - rat 

LOAEL = 93 mg/kg/day based on 

decreased body weight/bodyweight gain/food consumption, 

and kidney toxicity (suppurative 

inflammation in males; nonsuppurative interstitial nephritis in females) 

Inhalation short-term 

(1 to 30 days) 

(oral)NOAEL= 100 mg/kg/day 

(Inhalation absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Developmental toxicity study - rabbit 

LOAEL = 125 mg/kg/day based on 

body-weight loss during dosing 

period in the range-finding study 

Inhalation intermediateterm 

(1 to 6 months) 

(Oral) study 

NOAEL = 87 mg/kg/day 

(inhalation absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Chronic oral toxicity study - dog 

LOAEL = 195 mg/kg/day based on 

decreased body weight/bodyweight gain/food consumption 

Inhalation long-term 

(>6 months) 

(Oral) NOAEL = 7 mg/kg/day 

(inhalation absorption rate = 100%) 

UFA = 10x 

UFH = 10x 

FQPA SF = 1x 

LOC for MOE = 100 Chronic oral toxicity study - rat 

LOAEL = 93 mg/kg/day based on 

decreased body weight/bodyweight gain/food consumption, 

and kidney toxicity (suppurative 

inflammation in males; nonsuppurative interstitial nephritis in females) 


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TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSES AND ENDPOINTS FOR FORCHLORFENURON FOR USE IN HUMAN RISK

ASSESSMENT—Continued 

Exposure/Scenario Point of Departure and Uncertainty/ 

Safety Factors 

RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects 

Cancer 

(Oral, dermal, inhalation) 

Classification: Not likely to be a human carcinogen, based on two adequate rodent carcinogenicity studies. 

UFA = extrapolation from animal to human (interspecies). UFH = potential variation in sensitivity among members of the human population 

(intraspecies). UFL = use of a LOAEL to extrapolate a NOAEL. FQPA SF = FQPA Safety Factor. PAD = population adjusted dose (a = acute, c 

= chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to forchlorfenuron EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing forchlorfenuron tolerances in 

(40 CFR 180.569). EPA assessed dietary 

exposures from forchlorfenuron 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 

forchlorfenuron; therefore, a 

quantitative acute dietary exposure 

assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Departmemt of 

Agriculture (USDA) 1994–1996 and 

1998 Continuing Surveys of Food Intake 

by Individuals (CSFII). As to residue 

levels in food, EPA conducted a highly 

conservative chronic dietary exposure 

and risk assessment to support the new 

uses of forchlorfenuron. Tolerance level 

residues and 100 percent crop treated 

(PCT) information was incorporated into 

the assessment. Dietary Exposure 

Evaluation Model (DEEM version 7.81) 

default processing factors were used for 

apple juice, dried apples, dried pears, 

prune juice, cranberry juice, and grape 

juice. A processing factor was not used 

for raisins because a separate tolerance 

(resulting from an empirical processing 

study) is being recommended for this 

commodity. Additionally, the default 

processing factor was not used for 

prunes (dried plums) since data 

indicated that residues in prunes would 

not exceed the recommended plum 

tolerance. 

iii. Cancer. Forchlorfenuron has been 

classified as not likely to be 

carcinogenic based on carcinogenicity 

studies in the rat and mouse which 

showed no evidence of an increase in 

the incidence of tumors therefore a 

cancer dietary exposure and risk 

assessment is not required. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for forchlorfenuron. Tolerance level 

residues and/or 100 PCT were assumed 

for all existing and new food 

commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for forchlorfenuron in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

forchlorfenuron. 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. 

Forchlorfenuron is persistent and 

moderately mobile in soils. 

Forchlorfenuron is also a substituted 

urea plant growth regulator that is 

essentially stable to all routes of 

dissipation except sensitized 

photodegradation in water. Based on the 

Pesticide Root Zone Model/Exposure 

Analysis Modeling System (PRZM/ 

EXAMS) and Screening Concentration 

in Ground Water (SCI-GROW) models, 

the Estimated Environmental 

Concentrations (EECs) of 

forchlorfenuron from the newly 

proposed use on bushberries and the 

uses on almonds, sweet cherries, figs, 

pears, plums and pistachios under the 

EUP will not exceed the EECs from the 

grape and kiwi uses previously assessed 

by the Agency in document titled 

Drinking Water Assessment for 

Forchlorfenuron for Grape and Kiwi 

Uses. Therefore, the Agency has 

incorporated the drinking water EEC 

from the grape and kiwi analysis 

directly into this dietary assessment. 

For chronic dietary risk assessment, 

the water concentration of value 0.003 

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). 

Forchlorfenuron is not registered for 

any specific use patterns that would 

result in residential exposure. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of 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.’’

EPA has not made a common 

mechanism of toxicity finding asto 

forchlorfenuron and any other 

substances and forchlorfenuron 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 

forchlorfenuron 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(b)(2)(c) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) 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 database 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 (SF). In applying this 

provision, EPA either retains the default 

value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 


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2. Prenatal and postnatal sensitivity. 

The developmental and reproductive 

toxicity studies showed no evidence of 

increased sensitivity or susceptibility of 

young rats or rabbits following pre- and/ 

or postnatal exposure to 

forchlorfenuron. 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

forchlorfenuron is complete. 

ii. There is no indication that 

forchlorfenuron is a neurotoxic 

chemical and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

forchlorfenuron 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. 

EPA made conservative (protective) 

assumptions in the ground and surface 

water modeling used to assess exposure 

to forchlorfenuron in drinking water. 

EPA used similarly conservative 

assumptions to assess exposure to 

forchlorfenuron residues in food. These 

assessments will not underestimate the 

exposure and risks posed by 

forchlorfenuron. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Shortterm, intermediate-term, and chronicterm risks are evaluated by comparing 

the estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the margin of exposure 

(MOE) called for by the product of all 

applicable UFs is not exceeded. 

1. Acute risk. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single-oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, forchlorfenuron 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 chronic exposure to 

forchlorfenuron from food and water 

will utilize <1% of the cPAD for the 

general U.S. population and all 

subpopulations. There are no residential 

uses for forchlorfenuron. 

3. Short-term and intermediate-term 

risk. Short-term and Intermediate-term 

aggregate exposure takes into account 

short-term and intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Forchlorfenuron is not registered for 

any use patterns that would result in 

short-term and intermediate-term 

residential exposure. Therefore, the 

short-term and intermediate-term 

aggregate risk, individually is the sum of 

the risk from exposure to 

forchlorfenuron through food and water, 

which has already been addressed, and 

will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Since forchlorfenuron has 

been classified as not likely to be 

carcinogenic, aggregate cancer risk is 

not a concern. 

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 

forchlorfenuron residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate high performance liquid 

chromatography/ultraviolet (HPLC/UV) 

method (Method # CCRL-MTH-029) is 

available for enforcing tolerances of 

forchlorfenuron in/on members of the 

Bushberry Subgroup 13–07B and the 

commodities that are the subject of the 

proposed EUP. For this method, 

residues are extracted with methanol or 

acetone, diluted with water, and 

partitioned against hexane. Residues 

remaining in the aqueous fraction are 

then partitioned into dichloromethane 

(DCM) and if necessary further purified 

using a silica SPE cartridge. Residues 

are determined by HPLC/UV using 

external standards and residues are 

confirmed by liquid chromatography 

(LC) mass spectrometry (MS/MS) 

analysis. The validated limit of 

quantitation (LOQ) is 0.01 ppm for fruit 

and nut crops. 

B. International Residue Limits 

There is no established or proposed 

Canadian, Mexican or Codex MRLs for 

residues of forchlorfenuron in plant 

commodities. 

C. Revisions to Petitioned-For 

Tolerances 

The data submitted also supports a 

temporary tolerance of 0.15 parts per 

million (ppm) for almond, hulls. 

Therefore, a tolerance for residues of 

forchlorfenuron on almond, hulls at 

0.15 ppm is established. 

V. Conclusion 

Therefore, a permanent tolerance is 

established for residues of 

forchlorfenuron, N-(2-chloro-4- 

pyridinyl)-N’-phenyl urea, in or on 

bushberry subgroup 13–07B at tolerance 

level 0.01. 

Also, time-limited tolerances are 

established for residues of 

forchlorfenuron, N-(2-chloro-4- 

pyridinyl)-N’-phenyl urea, in or on 

almond at 0.01 ppm, almond, hulls at 

0.15 ppm, cherry, sweet at 0.01 ppm, fig 

at 0.01 ppm, pear at 0.01 ppm, pistachio 

at 0.01 ppm and plum, prune, fresh at 

0.01 ppm. A time limitation has been 

imposed because KIM-C1, LLC has 

submitted an application for an 

Experimental Use Permit and 

Temporary Tolerance for plant growth 

regulator Forchlorfenuron (CPPU), on 

six crops (almonds, cherry, fig, pear, 

pistachio, and plum/prune) to permit 

experimental use under semicommercial conditions, which will 

include collection of additional residue 

data where necessary to support 

permanent tolerances. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

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 final rule 

has been exempted from review under 

Executive Order 12866, this final 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 


sroberts on PROD1PC70 with PROPOSALS
47846 Federal Register / Vol. 73, No. 159 / Friday, August 15, 2008 / Rules and Regulations 

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 9, 2000) do not apply 

to this final rule. In addition, this final 

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) (Public Law 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), Public Law 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: August 8, 2008. 

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 180.569 is amended by 

adding bushberry subgroup 13–07B in 

the table to paragraph (a)(1); and 

revising the table in paragraph (a)(2) to 

read as follows: 

§ 180.569 Forchlorfenuron; tolerances for 

residues. 

(a) General (1) * * * 

Commodity Parts per million 

Bushberry subgroup 13–07B 0.01 

*****

(2)* * * 

Commodity Parts per million Expiration/revocation 

date 

Almond ..................................................................................................................................... 0.01 12/31/2011 

Almond, hulls ........................................................................................................................... 0.15 12/31/2011 

Cherry, sweet ........................................................................................................................... 0.01 12/31/2011 

Fig ............................................................................................................................................ 0.01 12/31/2011 

Pear ......................................................................................................................................... 0.01 12/31/2011 

Pistachio .................................................................................................................................. 0.01 12/31/2011 

Plum, prune, fresh 0.01 12/31/2011 


sroberts on PROD1PC70 with PROPOSALS
Federal Register / Vol. 73, No. 159 / Friday, August 15, 2008 / Rules and Regulations 47847 

* * * * * 

[FR Doc. E8–18946 Filed 8–14–08; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF TRANSPORTATION 

National Highway Traffic Safety 

Administration 

49 CFR Part 541 

[Docket No. NHTSA–2008–0049] 

RIN 2127–AK31 

Federal Motor Vehicle Theft Prevention 

Standard; Final Listing of 2009 Light 

Duty Truck Lines Subject to the 

Requirements of This Standard and 

Exempted Vehicle Lines for Model Year 

2009 

AGENCY: National Highway Traffic 

Safety Administration (NHTSA), 

Department of Transportation. 

ACTION: Final rule. 

SUMMARY: This final rule announces 

NHTSA’s determination that there are 

no new model year (MY) 2009 light duty 

truck lines subject to the parts-marking 

requirements of the Federal motor 

vehicle theft prevention standard 

because they have been determined by 

the agency to be high-theft or because 

they have a majority of interchangeable 

parts with those of a passenger motor 

vehicle line. This final rule also 

identifies those vehicle lines that have 

been granted an exemption from the 

parts-marking requirements because the 

vehicles are equipped with antitheft 

devices determined to meet certain 

statutory criteria. 

DATES: Effective Date: The amendment 

made by this final rule is effective 

August 15, 2008. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Rosalind Proctor, Consumer Standards 

Division, Office of International Policy, 

Fuel Economy and Consumer Programs, 

NHTSA, West Building, 1200 New 

Jersey Avenue, SE., (NVS–131, Room 

W43–302), Washington, DC 20590. Ms. 

Proctor’s telephone number is (202) 

366–0846. Her fax number is (202) 493–

0073. 

SUPPLEMENTARY INFORMATION: On April 

6, 2004, the agency published in the 

Federal Register (69 FR 17960) a final 

rule extending the parts-marking 

requirements to certain vehicle lines 

that were not previously subject to these 

requirements, specifically (1) all lowtheft passenger car lines; (2) all lowtheft multipurpose passenger vehicle 

(MPV) lines with a gross vehicle weight 

rating (GVWR) of 6,000 pounds or less; 

and (3) low-theft light-duty truck (LDT) 

lines with a GVWR of 6,000 pounds or 

less that have major parts that are 

interchangeable with a majority of the 

covered major parts of passenger cars or 

MPVs. The high-theft vehicle lines that 

were previously exempted under 49 

CFR part 543 on the grounds that they 

were equipped with an antitheft device 

as standard equipment were unaffected 

by the April 2004 final rule. The agency 

also stated that it would continue to 

grant exemptions for one vehicle line 

per manufacturer per model year. The 

final rule was effective September 1, 

2006. The final rule included a phasein provision which required at least 50 

percent of the production volume not 

subject to the current parts marking 

requirements (excluding light duty 

trucks) to have been marked by 

September 1, 2006. The remaining 

production volume not subject to the 

current parts marking requirements 

must have been marked by September 1, 

2007 (see 70 FR 28843, May 19, 2005). 

The purpose of the theft prevention 

standard (49 CFR part 541) is to reduce 

the incidence of motor vehicle theft by 

facilitating the tracing and recovery of 

parts from stolen vehicles. The standard 

seeks to facilitate such tracing by 

requiring that vehicle identification 

numbers (VINs), VIN derivative 

numbers, or other symbols be placed on 

major component vehicle parts. The 

theft prevention standard requires motor 

vehicle manufacturers to inscribe or 

affix VINs onto covered original 

equipment major component parts, and 

to inscribe or affix a symbol identifying 

the manufacturer and a common symbol 

identifying the replacement component 

parts for those original equipment parts, 

on all vehicle lines subject to the 

requirements of the standard. 

Section 33104(d) provides that once a 

line has become subject to the theft 

prevention standard, the line remains 

subject to the requirements of the 

standard unless it is exempted under 

§ 33106. Section 33106 provides that a 

manufacturer may petition to have a 

line exempted from the requirements of 

§ 33104, if the line is equipped with an 

antitheft device as standard equipment. 

The exemption is granted if NHTSA 

determines that the antitheft device is 

likely to be as effective as compliance 

with the theft prevention standard in 

reducing and deterring motor vehicle 

thefts. 

The agency annually publishes the 

names of those vehicle lines that have 

been determined to be high theft 

pursuant to 49 CFR part 541 and those 

that are exempted from the theft 

prevention standard under section 

33104. Appendix A to Part 541 

identifies those new light-duty truck 

lines listed for the first time that will be 

subject to the theft prevention standard 

beginning in a given model year. 

Appendix A–I to Part 541 identifies 

those vehicle lines that are or have been 

exempted from the theft prevention 

standard. 

On September 26, 2007, the final 

listing of MY 2008 high-theft vehicle 

lines was published in the Federal 

Register (72 FR 54600). The final listing 

identified that there again were no new 

vehicle lines that became subject to the 

theft prevention standard beginning 

with the 2008 model year. For MY 2009, 

there were no new light-duty truck lines 

identified that became subject to the 

theft prevention standard in accordance 

with the procedures published in 49 

CFR part 542. 

For MY 2009, the list of lines that 

have been exempted by the agency from 

the parts-marking requirements of Part 

541 includes nine vehicle lines newly 

exempted in full. The nine exempted 

vehicle lines are the Hyundai Genesis, 

Mazda 5, Subaru Forester, Jeep 

Wrangler, Chevrolet Equinox, Daimler 

smart USA fortwo, Nissan Rogue, Ford 

Escape, and Audi Q5. 

We note that the agency removes from 

the list being published in the Federal 

Register each year certain vehicles lines 

that have been discontinued more than 

5 years ago. Therefore, the Chevrolet 

Lumina/Monte Carlo (1996–1999) and 

the Chevrolet Malibu (2001–2003) have 

been removed from the Appendix A–I 

listing. The agency will continue to 

maintain a comprehensive database of 

all exemptions on our Web site. 

However, we believe that re-publishing 

a list containing vehicle lines that have 

not been in production for a 

considerable period of time is 

unnecessary. 

The vehicle lines listed as being 

exempt from the standard have 

previously been exempted in 

accordance with the procedures of 49 

CFR part 543 and 49 U.S.C., 33106. 

Therefore, NHTSA finds for good cause 

that notice and opportunity for 

comment on these listings are 

unnecessary. Further, public comment 

on the listing of selections and 

exemptions is not contemplated by 49 

U.S.C. Chapter 331. For the same 

reasons, since this revised listing only 

informs the public of previous agency 

actions and does not impose additional 

obligations on any party, NHTSA finds 

for good cause that the amendment 

made by this notice should be effective 

as soon as it is published in the Federal 

Register. 


sroberts on PROD1PC70 with PROPOSALS