58314 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

XI. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: September 24, 2004.

Donald R. Stubbs,

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. In § 180.910 the table is amended by 

revising the entry for ‘‘sodium 

thiosulfate’’ to read as two separate 

entries and inserting them alphabetically 

as follows:

§ 180.910 Inert ingredients used pre- and 

post-harvest.; exemptions from the 

requirement of a tolerance.

***

Inert Ingredients Limits Uses 

*******

Thiosulfuric acid, disodium salt, anhydrous. (CAS Reg. No 7772–98–7) .......................................... ........................ Dechlorinator, reducing 

agent

Thiosulfuric acid, disodium salt, pentahydrate. (CAS Reg. No. 10102–17–7) ................................... ........................ Dechlorinator, reducing 

agent

*******

[FR Doc. 04–21933 Filed 9–30–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY

40 CFR Part 180

[OPP–2004–0272; FRL–7681–5]

Forchlorfenuron; Pesticide Tolerance

AGENCY: Environmental Protection 

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a 

tolerance for residues of 

forchlorfenuron, N -(2-chloro-4-

pyridinyl)-N′-phenylurea in or on grapes 

and kiwifruit. Siemer & Associates, Inc. 

on behalf of KIM-C1, LLC requested this 

tolerance under the Federal Food, Drug, 

and Cosmetic Act (FFDCA), as amended 

by the Food Quality Protection Act of 

1996 (FQPA).

DATES: This regulation is effective 

September 30, 2004. Objections and 

requests for hearings must be received 

on or before November 29, 2004.

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2004–

0272. All documents in the docket are 

listed in the EDOCKET index at http:/

/www.epa.gov/edocket. Although listed 

in the index, some information is not 

publicly available, i.e., 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 either 

electronically in EDOCKET or in hard 

copy at the Public Information and 

Records Integrity Branch (PIRIB), Rm. 

119, Crystal Mall #2, 1801 S. Bell St., 

Arlington, VA. This docket facility is 

open from 8:30 a.m. to 4 p.m., Monday 

through Friday, excluding legal 

holidays. The docket telephone number 

is (703) 305–5805.

FOR FURTHER INFORMATION CONTACT:

Dennis McNeilly, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW.,Washington, 

DC 20460–0001; telephone number: 

703–308–6742; e-mail 

address:mcneilly.dennis@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:

• Crop production (NAICS 111), e.g., 

agricultural workers; greehouse, 

nursery, and floriculture workers; 

farmers.

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers.

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS 

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 provides 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.

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58315

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information?

In addition to using EDOCKET (http:/

/www.epa.gov/edocket/), you may 

access this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http://

www.gpoaccess.gov/ecfr/. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go directly 

to the guidelines at http://www.epa.gpo/

opptsfrs/home/guidelin.htm/.

II. Background and Statutory Findings

In the Federal Register of May 16, 

2003 (68 FR 26607–26611) (FRL–7303–

2), 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 3F6550) by 

Siemer & Associates, 4672 W. Jennifer, 

Suite 103, Fresno, California 93722. The 

petition requested that 40 CFR 180.569 

be amended by establishing a tolerance 

for residues of the plant growth 

regulator forchlorfenuron, N-(2-chloro4-pyridinyl)-N′-phenylurea, in or on 

grapes, raisins and kiwifruit at 0.03 

parts per million (ppm). That notice 

included a summary of the petition 

prepared by Siemer & Associates, Inc., 

the registrant. The proposed uses are the 

first section 3 tolerances for this new 

active ingredient. Time-limited 

tolerances are currently in effect (69 FR 

48799–48805, Aug 11, 2004) for 

residues of forchlorfenuron in or on 

grapes, kiwifruit, apples, blueberries, 

cranberries, figs, pears, plums (fresh), 

olives and almonds. These time-limited 

tolerances were established in 

conjunction with the granting of an 

Experimental Use Permit (EUP) 

originally issued on May 21, 2001. The 

time-limited tolerances were first 

established in the Federal Register on 

May 7, 2001 (66 FR 22930–22936 (FRL 

6781–4)). Agency review of the 

submitted residue studies indicate that 

higher tolerances are required for raisins 

at 0.06 ppm and kiwifruit at 0.04 ppm. 

There were no comments received in 

response to the notice of filing.

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....’’

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of FFDCA 

and a complete description of the risk 

assessment process, see the final rule on 

Bifenthrin Pesticide Tolerances (62 FR 

62961, November 26, 1997) (FRL–5754–

7).

III. Aggregate Risk Assessment and 

Determination of Safety

Consistent with 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, 

consistent with section 408(b)(2) of 

FFDCA, for a tolerance for residues of 

forchlorfenuron, N-(2-chloro-4-

pyridinyl)-N′-phenylurea on grapes at 

0.03 ppm; raisins at 0.06 ppm; and 

kiwifruit at 0.04 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, 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. The 

nature of the toxic effects caused by 

forchlorfenuron is discussed in Table 1 

of this unit as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies 

reviewed.

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY

Guideline No. Study Type Results 

870.3100 90 –day oral toxicity- rat .. NOAEL = M ≥ 400, F = 84 milligrams/kilogram/day (mg/kg/day) 

LOAEL = M = not determined, F = 428: decrease BW gain and food efficiency mg/

kg/day

870.3150 90 day oral toxicity -dogs NOAEL = M = 16.8, F = 19.1 mg/kg/day 

LOAEL = M = 162.4, F = 188.7; decreases (≥ 10%) in BW gain, FC and food efficiency mg/kg/day

870.3700 Developmental tox-rat ...... Maternal NOAEL = 200 mg/kg/day 

Maternal LOAEL = 400 mg/kg/day based on increased incidence of alopecia: decrease in BW and BW gains

Developmental NOAEL = 200 mg/kg/day

Developmental LOAEL = 400 mg/kg/day based on decreased mean fetal BW

870.3700 Developmental tox - nonrodent.Maternal NOAEL = ≥100 mg/kg/day 

Maternal LOAEL = not determined

Developmental NOAEL = ≥100 mg/kg/day

Developmental LOAEL = not determined

58316 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

TABLE 1.—SUBCHRONIC, CHRONIC, AND OTHER TOXICITY—Continued

Guideline No. Study Type Results 

870.3800 Reproduction and fertility 

effects.

Parental/Systemic NOAEL = M = 11/13, F= 13/15 mg/kg/day 

Parental/Systemic LOAEL = 144–202 mg/kg/day based on decreased FC in F0 and 

F1 M; clinical signs of toxicity and lower BW in F1 M and F and growth retardation 

in F1 and F2 pups

Reproductive NOAEL = M = 144/168, F = 169/202 mg/kg/day

Reproductive LOAEL = 544–926 mg/kg/day based on increased pup mortality (F1a, 

F1b and F2a), emaciation in F1b, and decrease in F2 pups/litter

870.4300 Chronic carcinogenicity rat NOAEL = M = 7, F = 9 mg/kg/day 

LOAEL = M = 93, F = 122 mg/kg/day based on Reduced BW and BW gain and FC; 

kidney toxicity (M = suppurative inflammation, F = non-suppurative interstitial nephritis)

No evidence of carcinogenicity

870.4100 1-year feeding study-dogs NOAEL (in mg/kg/day): M = 87, F = 91

LOAEL (in mg/kg/day): M = 195, F = 246, decreases in BW, BW gains and FC

870.4200 18–month carcinogenicity 

study-mice.

NOAEL (in mg/kg/day): M = 10.0, F = 9.9

LOAEL (in mg/kg/day): M = 991.4, F = 1001.8, decreases in BW and BW gains in M 

and F

Not carcinogenic

870.7485 Metabolism study-rat ........ Recovery of 97% (M and F) by 168 hours. Absorbed dose 72–84%. Urine 62–74%. 

Feces 16–28%. Biliary excretion, 20–23% in bile. Urine and feces, elimination 

half-life 13.1–16.2 hours. Analyses identified parent and six metabolites in excreta. 

Parent not in urine and 1–2% in feces. Major metabolite forchlorfenuron-sulfate in 

urine of males (84%) and females (57%). Hydroxy forchlorfenuron (2 isomers) 

<4% in urine; predominant metabolite in feces (11% males and 18% females). 

Other metabolites: hydroxy forchlorfenuron-sulfate, methoxy forchlorfenuron-sulfate, 

forchlorfenuron glucuronide and dihydroxy forchlorfenuron (each <5%). Metabolism of forchlorfenuron in rats: conjugation with sulfate at phenyl ring before (major 

pathway), conjugation with glucuronide at phenyl ring, methylation of hydroxy 

group of hydroxy forchlorfenuron-sulfate and hydroxylation of both chloropyridinyl 

and phenyl rings.

870.5375 In vitro mammalian cytogenetics assay in Chinese Hamster CHO-KI 

cells 10, 20, 40, and 80 

μg/mL ± S9 activation.

No increase in chromosomal aberrations over background ± S9

870.5550 Unscheduled DNA synthesis in primary rat 

hepatocytes/mammalian 

cell cultures 0.1 to 30 

7μg/mL.

No increase in unscheduled DNA synthesis

870.5265 Salmonella/mammalian 

activation gene mutation assay.

10–1000 μg/plate +S9 .....

2–200 μg/plate -S9 ..........

Evidence of a positive response in tester strain TA1535 in absence of S9 at 50, 100, 

and 200 μg/plate

870.5265 Salmonella/mammalian 

activation gene mutation assay.

10–1,000 μg/plate +S9 ....

2–200 μg/plate -S9 ..........

Evidence of induced mutany colonies over background in tester strain TA1535 in absence of S9

B. Toxicological Endpoints

The dose at which no adverse effects 

are observed (the NOAEL) from the 

toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. An UF of 100 is 

routinely used, 10X to account for 

interspecies differences and 10X for 

intraspecies differences.

Three other types of safety or 

uncertainty factors may be used: 

‘‘Traditional uncertainty factors;’’ the 

‘‘special FQPA safety factor;’’ and the 

‘‘default FQPA safety factor.’’ By the 

term ‘‘traditional uncertainty factor,’’

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58317

EPA is referring to those additional 

uncertainty factors used prior to FQPA 

passage to account for database 

deficiencies. These traditional 

uncertainty factors have been 

incorporated by the FQPA into the 

additional safety factor for the 

protection of infants and children. The 

term ‘‘special FQPA safety factor’’ refers 

to those safety factors that are deemed 

necessary for the protection of infants 

and children primarily as a result of the 

FQPA. The ‘‘default FQPA safety factor’’

is the additional 10X safety factor that 

is mandated by the statute unless it is 

decided that there are reliable data to 

choose a different additional factor 

(potentially a traditional uncertainty 

factor or a special FQPA safety factor).

For dietary risk assessment (other 

than cancer) the Agency uses the UF to 

calculate an acute or chronic reference 

dose (acute RfD or chronic RfD) where 

the RfD is equal to the NOAEL divided 

by an UF of 100 to account for 

interspecies and intraspecies differences 

and any traditional uncertainty factors 

deemed appropriate (RfD = NOAEL/UF). 

Where a special FQPA safety factor or 

the default FQPA safety factor is used, 

this additional factor is applied to the 

RfD by dividing the RfD by such 

additional factor. The acute or chronic 

Population Adjusted Dose (aPAD or 

cPAD) is a modification of the RfD to 

accommodate this type of safety factor.

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the LOC. For example, when 

100 is the appropriate UF (10X to 

account for interspecies differences and 

10X for intraspecies differences) the 

LOC is 100. To estimate risk, a ratio of 

the NOAEL to exposures (margin of 

exposure (MOE) = NOAEL/exposure) is 

calculated and compared to the LOC.

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify 

carcinogenic risk. The Q* approach 

assumes that any amount of exposure 

will lead to some degree of cancer risk. 

A Q* is calculated and used to estimate 

risk which represents a probability of 

occurrence of additional cancer cases 

(e.g., risk). An example of how such a 

probability risk is expressed would be to 

describe the risk as one in one hundred 

thousand (1 X 10-5), one in a million (1 

X 10-6), or one in ten million (1 X 10-7). 

Under certain specific circumstances, 

MOE calculations will be used for the 

carcinogenic risk assessment. In this 

non-linear approach, a ‘‘point of 

departure’’ is identified below which 

carcinogenic effects are not expected. 

The point of departure is typically a 

NOAEL based on an endpoint related to 

cancer effects though it may be a 

different value derived from the dose 

response curve. To estimate risk, a ratio 

of the point of departure to exposure 

(MOEcancer = point of departure/

exposures) is calculated.

A summary of the toxicological 

endpoints for forchlorfenuron used for 

human risk assessment is shown in the 

following Table 2:

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FORCHLORFENURON FOR USE IN HUMAN RISK

ASSESSMENT

Exposure Scenario Dose(mg/kg/day) Endpoint Study 

Acute Dietary NOAEL - assumed to be 

100

UF = 100

aPAD = 1.0 mg/kg/day Rabbit developmental study

Chronic Dietary NOAEL = 7.0 Decreases in body weight, 

body weight gain and 

food consumption as well 

as effects on the kidney 

at the LOEAL of 93 and 

122 mg/ kg/day for males 

and females, respectively. 

2–year rat feeding study

UF = 100

FQPA = 1x

Chronic RfD = 0.07 mg/kg/

day 

Chronic Population-Adjusted Dose (cPAD) = 

0.07 mg/kg/day; apply to 

all population subgroups.

NA

Short-Term (Dermal) NOAEL = 200 Decreases in maternal 

body weights and body 

weight gains as well as a 

decrease in mean fetal 

body weights.

developmental rat study

Intermediate-Term (Dermal) NOAEL = 87 Based on decreases in 

body weight, bw gain, 

and food consumption.

1–Year feeding study in dogs

Long-Term (Dermal) NA Based on the limited use, 

long-term exposure is not 

expected anda risk assessment not conducted

NA

Short-Term (Inhalation) NOAEL = 200 Same as short-term dermal developmental rat study

Intermediate-Term (Inhalation) NOAEL = 87 Same as intermediate-term 

dermal

1–Year feeding study in dogs

58318 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

TABLE 2.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR FORCHLORFENURON FOR USE IN HUMAN RISK

ASSESSMENT—Continued

Exposure Scenario Dose(mg/kg/day) Endpoint Study 

Long-Term (Inhalation) NA Based on the limited use, 

long-term exposure is not 

expected anda risk assessment not conducted

NA

Cancer NA Not likely to be a human 

carcinogen

NA

C. Exposure Assessment

1. Dietary exposure from food and 

feed uses— i. Acute exposure. In 

conducting this acute dietary risk 

assessment the Lifeline Model Version 

2.0 and the Dietary Exposure Evaluation 

Model (DEEMTM, Version 2.03) analysis 

evaluated the individual food 

consumption as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII) and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the acute exposure assessments: 

Tolerance-level residues and 100% crop 

treated assumptions were used. DEEM 

(Version 7.81) default processing factors 

were used to modify the tolerance 

values for processed commodities for 

which separate tolerances are not being 

established. 

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment the 

Lifeline Model Version 2.0 and the 

DEEMTM analysis evaluated the 

individual food consumption as 

reported by respondents in the USDA 

1994–1996 and 1998 Nationwide 

Continuing Surveys of Food Intake by 

Individuals (CSFII) and accumulated 

exposure to the chemical for each 

commodity. The following assumptions 

were made for the chronic exposure 

assessments: A conservative chronic 

dietary exposure analysis was 

performed for the general U.S. 

population and various population 

subgroups. Tolerance-level residues and 

100% crop treated assumptions were 

used. The 1-in-10-year average surface 

water concentration from the Pesticide 

Root Zone Model/Exposure Analysis 

Modeling System (PRZM-EXAMS) 

Model was used as a point estimate for 

drinking water in the dietary analyses. 

iii. Cancer. A quantitative cancer 

dietary exposure assessment is not 

needed for forchlorfenuron since it is 

not a carcinogen.

2. Dietary exposure from drinking 

water. The Agency usesthe FQPA Index 

Reservoir Screening Tool (FIRST) or the 

PRZM/EXAMS, to produce estimates of 

pesticide concentrations in an index 

reservoir. The screening concentration 

in ground water (SCI-GROW) model is 

used to predict pesticide concentrations 

in shallow ground water. For a 

screening-level assessment for surface 

water EPA will use FIRST (a tier 1 

model) before using PRZM/EXAMS (a 

tier 2 model). The FIRST model is a 

subset of the PRZM/EXAMS model that 

uses a specific high-end runoff scenario 

for pesticides. Both FIRST and PRZM/

EXAMS incorporate an index reservoir 

environment, and both models include 

a percent crop area factor as an 

adjustment to account for the maximum 

percent crop coverage within a 

watershed or drainage basin.

None of these models include 

consideration of the impact processing 

(mixing, dilution, or treatment) of raw 

water for distribution as drinking water 

would likely have on the removal of 

pesticides from the source water. The 

primary use of these models by the 

Agency at this stage is to provide a 

screen for sorting out pesticides for 

which it is unlikely that drinking water 

concentrations would exceed human 

health levels of concern.

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency has 

generally not used estimated 

environmental drinking water 

concentrations (EDWCs), which are the 

model estimates of a pesticide’s 

concentration in water. EDWCs derived 

from these models are used to quantify 

drinking water exposure and risk as a 

%RfD or %PAD. Instead, drinking water 

levels of comparison (DWLOCs) are 

calculated and used as a point of 

comparison against the model estimates 

of a pesticide’s concentration in water. 

DWLOCs are theoretical upper limits on 

a pesticide’s concentration in drinking 

water in light of total aggregate exposure 

to a pesticide in food, and from 

residential uses. Since DWLOCs address 

total aggregate exposure to 

forchlorfenuron they are further 

discussed in the aggregate risk Unit III. 

E. below.

As EPA has gathered more 

information regarding pesticide residues 

in drinking water and drinking water 

consumption amounts, it has been 

working toward refining the screeninglevel DWLOC approach to conducting 

aggregate risk assessments that combine 

exposures across all pathways. As a first 

step in this process, EPA has begun 

using the chronic and cancer EDWCs 

directly in chronic and cancer dietary 

exposure assessments to calculate 

aggregate dietaryfood + water risk. This 

is done by using the relevant PRZMEXAMS value as a residue for water (all 

sources) in the dietary exposure 

assessment. The principal advantage of 

this approach is that the actual 

individual body weight and water 

consumption data from the Continuing 

Survey of Food Intake by Individuals 

(CSFII) are used, rather than assumed 

weights and water consumption for 

broad age groups.

Accordingly, the 1-in-10-year average 

surface water concentration from the 

PRZM-EXAMS Model was used as a 

point estimate for drinking water in the 

chronic dietary analysis. Estimated 

concentrations in drinking water were 

not included in the acute analysis. 

Instead, the maximum allowable 

exposure from drinking water was 

calculated by subtracting the exposure 

in food from the total allowable 

exposure. The maximum allowable 

exposure from drinking water is 

converted to the maximum allowable 

drinking water concentration, or 

DWLOCs. These values are then 

compared to the estimated drinking 

water concentrations.

Based on the PRZM/EXAMS and SCIGROW models, the EDWCs of 

forchlorfenuron for chronic exposures 

are estimated to be 0.32 parts per billion 

(ppb) for surface water and 0.003 ppb 

for ground water. Based on the PRZM/

EXAMS and SCI-GROW models, the 

EDWCs of forchlorfenuron for acute 

exposures are estimated to be 0.54 ppb 

for surface water and 0.003 ppb for 

ground water.

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58319

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 

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 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 

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 the policy statements released by 

EPA’s Office of Pesticide Programs 

(OPP) concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s web site 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 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 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. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. 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 safety factor value 

based on the use of traditional 

uncertainty factors and/or special FQPA 

safety factors, as appropriate.

2. Prenatal and postnatal sensitivity. 

There is a lack of increased qualitative 

or quantitative susceptibility in 

developmental or reproductive studies. 

There are no concerns and no residual 

uncertainties with regard to pre-and/or 

postnatal toxicity.

3. Conclusion. As indicated, available 

data do not show any increased 

susceptibility to the young from 

exposure to forchlorfenuron and there 

are no residual uncertainties regarding 

pre- or post-natal toxicity. There is an 

adequate toxicity database for 

forchlorfenuron. As there was no 

evidence of neurotoxicity, it is not 

necessary to require a developmental 

neurotoxicity study. In addition, data 

used to evaluate exposure are adequate, 

and conservative assumptions are being 

used to evaluate aggregate exposure 

through food and drinking water. As a 

result, exposures are probably 

considerably overestimated. 

Accordingly, EPA concludes it has 

reliable data supporting removal of the 

additional FQPA 10-fold safety factor 

for the protection of infants and 

children.

E. Aggregate Risks and Determination of 

Safety

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency either 

calculates DWLOCs which are used as a 

point of comparison against EDWCs or 

uses the EDWCs directly in the 

aggregate exposure assessment. DWLOC 

values are not regulatory standards for 

drinking water. DWLOCs are theoretical 

upper limits on a pesticide’s 

concentration in drinking water in light 

of total aggregate exposure to a pesticide 

in food and residential uses. In 

calculating a DWLOC, the Agency 

determines how much of the acceptable 

exposure (i.e., the PAD) is available for 

exposure through drinking water [e.g., 

allowable chronic water exposure (mg/

kg/day) = cPAD - (average food + 

residential exposure). This allowable 

exposure through drinking water is used 

to calculate a DWLOC.

A DWLOC will vary depending on the 

toxic endpoint, drinking water 

consumption, and body weights. Default 

body weights and consumption values 

as used by the EPA’s Office of Water are 

used to calculate DWLOCs: 2 liter (L)/

70 kg (adult male), 2L/60 kg (adult 

female), and 1L/10 kg (child). Default 

body weights and drinking water 

consumption values vary on an 

individual basis. This variation will be 

taken into account in more refined 

screening-level and quantitative 

drinking water exposure assessments. 

Different populations will have different 

DWLOCs. Generally, a DWLOC is 

calculated for each type of risk 

assessment used: Acute, short-term, 

intermediate-term, chronic, and cancer. 

As explained above, however, EPA is 

beginning to use EDWCs directly in 

estimating aggregate exposure in 

chronic and cancer assessment.

When EDWCs for surface water and 

ground water are less than the 

calculated DWLOCs, OPP concludes 

with reasonable certainty that exposures 

to the pesticide in drinking water (when 

considered along with other sources of 

exposure for which OPP has reliable 

data) would not result in unacceptable 

levels of aggregate human health risk at 

this time. Because OPP considers the 

aggregate risk resulting from multiple 

exposure pathways associated with a 

pesticide’s uses, levels of comparison in 

drinking water may vary as those uses 

change. If new uses are added in the 

future, OPP will reassess the potential 

impacts of residues of the pesticide in 

drinking water as a part of the aggregate 

risk assessment process.

1. Acute risk. From the Lifeline 

Model, the U.S. population and all 

population subgroups had risk estimates 

that were below 1% of the acute 

population adjusted dose (aPAD) from 

exposure to forchlorfenuron in food. 

The most highly exposed population 

subgroup was children 1–2 years old, 

which had a risk estimate of 0.08% of 

the aPAD. The general U.S. population 

utilized 0.02% of the aPAD. In addition, 

there is potential for acute dietary 

exposure to forchlorfenuron in drinking 

water. After calculating DWLOCs and 

comparing them to the EDWCs for 

surface and ground water, EPA does not 

expect the aggregate exposure to exceed 

100% of the aPAD, as shown in the 

following Table 3:

58320 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO FORCHLORFENURON

Population Subgroup % aPAD 

(Food) 

Surface Water 

EDWCs (ppb) 

Ground Water 

EDWCs (ppb) 

Acute DWLOC 

(ppb) 

U.S. Population 0.000157 0.54 0.003 35,000

All Infants 0.000526 0.54 0.003 10,000

Children 1–2 years 0.000846 0.54 0.003 10,000

Children 3–5 years 0.000557 0.54 0.003 10,000

Children 6–12 years 0.000217 0.54 0.003 10,000

Youth 13–19 years 0.000089 0.54 0.003 30,000

Adults 20–49 years 0.000101 0.54 0.003 35,000

Adults 50+ years 0.000105 0.54 0.003 35,000

Females 13–49 0.000112 0.54 0.003 30,000

1 Maximum Allowable Water Exposure = PAD - sum of all quantifiable exposures. 

2 Drinking Water Level of Comparison = Maximum Allowable Water Exposure x Body Weight (10 kg infants and children, 60 kg females, 70 kg 

all others) x 1,000 μg/mg ÷ Consumption (1 L/day infants and children, 2 L/day all others). 

2. Chronic risk. The U.S. population 

and all population subgroups had risk 

estimates that were below 1% of the 

chronic population adjusted dose 

(cPAD) from exposure to 

forchlorfenuron in food. The most 

highly exposed population subgroup 

was children 1–2 years old, which had 

a risk estimate of 0.3% of the cPAD. 

There are no residential uses for 

forchlorfenuron that result in chronic 

residential exposure to forchlorfenuron. 

Based on the use pattern, chronic 

residential exposure to residues of 

forchlorfenuron is not expected. 

However, there is potential for chronic 

dietary exposure to forchlorfenuron in 

drinking water. The Agency does not 

expect the aggregate exposure to exceed 

100% of the cPAD, as shown in Table 

4 of this unit:

Chronic (non-cancer) aggregate risk is 

the sum of exposures resulting from 

chronic dietary food + chronic drinking 

water + chronic residential uses. 

Forchlorfenuron has no registered or 

proposed residential uses. Therefore, 

this risk assessment is the aggregate of 

chronic food and chronic drinking water 

exposures only. As stated above, the 

drinking water EDWCs were included in 

the dietary exposure analysis. As a 

result, the aggregate risk assessment is 

equivalent to the dietary analysis, the 

results of which are reported in Table 4 

below. The results of the DEEM-FCID 

analysis were comparable to those of the 

Lifeline analysis. In the DEEM-FCID 

analysis, the general U.S. population 

and all population subgroups used <1% 

of the cPAD.

TABLE 4—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON–CANCER) EXPOSURE TO FORCHLORFENURON

Population Subgroup 

Exposure (mg/kg/day) %cPAD 

Lifeline DEEM–FCID Lifeline DEEM–FCID 

General U.S. Population 0.000032 0.000040 <1.0 <1.0

All Infants (<1 year old) 0.000122 0.000142 <1.0 <1.0

Children 1–2 years old 0.000217 0.000230 <1.0 <1.0

Children 3–5 years old 0.000140 0.000140 <1.0 <1.0

Children 6–12 years old 0.000047 0.000053 <1.0 <1.0

Youth 13–19 years old 0.000017 0.000021 <1.0 <1.0

Adults 20–49 years old 0.000019 0.000023 <1.0 <1.0

Adults 50+ years old 0.000020 0.000026 <1.0 <1.0

Females 13–49 years old 0.000021 0.000025 <1.0 <1.0

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level).

Forchlorfenuron 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. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level).

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 58321

Forchlorfenuron 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.

5. Aggregate cancer risk for U.S. 

population. Forchlorfenuron was 

classified as not likely to be a human 

carcinogen, and therefore 

forchlorfenuron is not expected to pose 

a cancer risk.

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to 

forchlorfenuron residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

The proposed enforcement method is 

a high performance liquid 

chromatography with ultra violet 

detection HPLC/UV procedure that 

measures parent forchlorfenuron. The 

method, including the confirmatory 

Mass spectrometry with mass 

spectrometry (MS/MS) analysis, has 

been adequately validated. The 

Analytical Chemistry Branch of BEAD 

performed a tolerance method 

validation (TMV) trial on the 

enforcement method using grapes. For 

grapes, the laboratory reported a limit of 

quantitation of 0.010 ppm and a limit of 

detection of 0.002 ppm.

An enforcement method for the 

regulable residue in animal 

commodities is not required for section 

3 registrations on grapes and kiwifruit.

Adequate enforcement methodology 

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 MRLs for forchlorfenuron.

C. Conditions

Conditions of registration are 

discussed in the Notice of Registration.

V. Conclusion

Therefore, tolerances are established 

for residues of forchlorfenuron, N-(2-

chloro-4-pyridinyl)-N′-phenylurea, in or 

on grapes at 0.03 ppm; raisins at 0.06 

ppm; and kiwifruit at 0.04 ppm.

VI. Objections and Hearing Requests

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to FFDCA 

by FQPA, EPA will continue to use 

those procedures, with appropriate 

adjustments, until the necessary 

modifications can be made. The new 

section 408(g) of FFDCA provides 

essentially the same process for persons 

to ‘‘object’’ to a regulation for an 

exemption from the requirement of a 

tolerance issued by EPA under new 

section 408(d) of FFDCA, as was 

provided in the old sections 408 and 

409 of FFDCA. However, the period for 

filing objections is now 60 days, rather 

than 30 days.

A. What Do I Need to Do to File an 

Objection or Request a Hearing?

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

OPP–2004–0272 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before November 29, 2004.

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice.

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255.

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit VI.A., you should also send a copy 

of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

OPP–2004–0272, to: Public Information 

and Records Integrity Branch, 

Information Resources and Services 

Division (7502C), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. In person 

or by courier, bring a copy to the 

location of the PIRIB described in 

ADDRESSES. You may also send an 

electronic copy of your request via email to: opp-docket@epa.gov. Please use 

an ASCII file format and avoid the use 

of special characters and any form of 

encryption. Copies of electronic 

objections and hearing requests will also 

be accepted on disks in WordPerfect 

6.1/8.0 or ASCII file format. Do not 

include any CBI in your electronic copy. 

You may also submit an electronic copy 

of your request at many Federal 

Depository Libraries.

B. When Will the Agency Grant a 

Request for a Hearing?

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32).

VII. 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 due to its lack of 

58322 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Rules and Regulations 

significance, 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). This final rule does not 

contain any information collections 

subject to OMB approval under the 

Paperwork Reduction Act (PRA), 44 

U.S.C. 3501 et seq., or impose any 

enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule.

VIII. Congressional Review Act

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this rule and other 

required information to the U.S. Senate, 

the U.S. House of Representatives, and 

the Comptroller General of the United 

States prior to publication of this final 

rule in the Federal Register. This final 

rule is not a ‘‘major rule’’ as defined by 

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements.

Dated: September 21, 2004.

James Jones,

Director, 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 

redesignating paragraph (a) as paragraph 

(a)(2), by removing the entries for grape 

and kiwifruit from the table in newly 

designated paragraph (a)(2), and by 

adding new paragraph (a)(1) to read as 

follows:

§ 180.569 Forchlorfenuron; tolerances for 

residues.

(a) General. (1) Tolerances are 

established for residues of the plant 

growth regulator forchlorfenuron; N-(2-

chloro-4-pyridinyl)-N′phenyl urea in or 

on the following commodities:

Commodity Parts per

million 

Grape .................................... 0.03

Grape, raisin ......................... 0.06

Kiwifruit ................................. 0.04

* * * * *

[FR Doc. 04–21932 Filed 9–29–04; 8:45 am]

BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300

[FRL–7821–8] 

National Oil and Hazardous 

Substances Pollution Contingency 

Plan; National Priorities List

AGENCY: Environmental Protection 

Agency.

ACTION: Final rule; Notice of deletion of 

the Love Canal Superfund site from the 

National Priorities List. 

SUMMARY: The United States 

Environmental Protection Agency (EPA) 

Region II Office announces the deletion 

of the Love Canal Superfund site (Love 

Canal site) from the National Priorities 

List (NPL). The Love Canal site is 

located in the City of Niagara Falls, 

Niagara County, New York. The NPL 

constitutes appendix B to the National 

Oil and Hazardous Substances Pollution 

Contingency Plan (NCP), 40 CFR part 

300, which EPA promulgated pursuant 

to section 105 of the Comprehensive 

Environmental Response, 

Compensation, and Liability Act of 1980 

(CERCLA), as amended. 

EPA and the State of New York, 

through the Department of 

Environmental Conservation (NYSDEC), 

have determined that all appropriate 

response actions have been