55286 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

was published on December 17, 1997 

(62 FR 66020), and was provided to the 

Chief Counsel for Advocacy of the Small 

Business Administration. Taking into 

account this analysis, and available 

information concerning the pesticides 

listed in this rule, the Agency hereby 

certifies that this final rule will not have 

a significant economic impact on a 

substantial number of small entities. 

Specifically, as per the 1997 notice, EPA 

has reviewed its available data on 

imports and foreign pesticide usage and 

concludes that there is a reasonable 

international supply of food not treated 

with canceled pesticides. Furthermore, 

for the pesticides named in this final 

rule, the Agency knows of no 

extraordinary circumstances that exist 

as to the present revocations that would 

change EPA’s previous analysis. 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. 

VI. 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 12, 2005 

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. In section 180.133, paragraph (a) is 

revised to read as follows: 

§ 180.133 Lindane; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of the 

insecticide lindane (gamma isomer of 

1,2,3,4,5,6-hexachlorocyclohexane) in or 

on raw agricultural commodities as 

follows: 

Commodity Parts per 

million 

Expiration/ 

Revocation 

Date 

Broccoli ............. 1.0 4/26/07 

Brussels sprouts 1.0 4/26/07 

Cabbage ........... 1.0 4/26/07 

Cattle, fat .......... 7.0 None 

Cauliflower ........ 1.0 4/26/07 

Goat, fat ............ 7.0 None 

Hog, fat ............. 4.0 None 

Horse, fat .......... 7.0 None 

Sheep, fat ......... 7.0 None 

* * * * * 

[FR Doc. 05–18829 Filed 9–20–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0259; FRL–7737–9] 

Boscalid; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

boscalid, 3-pyridinecarboxamide, 2- 

chloro-N-(4′-chloro[1,1′-biphenyl]-2-yl) 

in or on tangerines. This action is in 

response to EPA’s granting of an 

emergency exemption under section 18 

of the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) 

authorizing use of the pesticide on 

mandarin oranges and mandarin 

hybrids. ‘‘Tangerines’’ is the accepted 

regulatory term used for these crops and 

a tolerance on tangerines covers both 

mandarin oranges and mandarin 

hybrids. This regulation establishes a 

maximum permissible level for residues 

of boscalid in this food commodity. The 

tolerance will expire and is revoked on 

December 31, 2008. 

DATES: This regulation is effective 

September 21, 2005. Objections and 

requests for hearings must be received 

on or before November 21, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number OPP–2005–

0259. 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 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55287 

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: 

Andrew Ertman, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: Sec–18–

Mailbox@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 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 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. 

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 on E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of the Federal Food, Drug, and 

Cosmetic Act (FFDCA), 21 U.S.C. 346a, 

is establishing a tolerance for residues of 

the fungicide boscalid, 3- 

pyridinecarboxamide, 2-chloro-N-(4′- 

chloro[1,1′-biphenyl]-2-yl) in or on 

tangerines at 2.0 parts per million 

(ppm). This tolerance will expire and is 

revoked on December 31, 2008. EPA 

will publish a document in the Federal 

Register to remove the revoked 

tolerance from the Code of Federal 

Regulations. 

Section 408(l)(6) of the FFDCA 

requires EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on section 18 related tolerances 

to set binding precedents for the 

application of section 408 of the FFDCA 

and the new safety standard to other 

tolerances and exemptions. Section 

408(e) of the FFDCA allows EPA to 

establish a tolerance or an exemption 

from the requirement of a tolerance on 

its own initiative, i.e., without having 

received any petition from an outside 

party. 

Section 408(b)(2)(A)(i) of the FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’

Section 408(b)(2)(A)(ii) of the FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of the FFDCA requires EPA 

to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue. . . .’’

Section 18 of the FIFRA authorizes 

EPA to exempt any Federal or State 

agency from any provision of FIFRA, if 

EPA determines that ‘‘emergency 

conditions exist which require such 

exemption.’’ This provision was not 

amended by the Food Quality Protection 

Act of 1996 (FQPA). EPA has 

established regulations governing such 

emergency exemptions in 40 CFR part 

166. 

III. Emergency Exemption for Boscalid 

on Mandarin Oranges and Mandarin 

Hybrids and FFDCA Tolerances 

The state of California requested the 

use of boscalid (pre-mixed with the 

chemical pyraclostrobin as the product 

Pristine) on mandarin oranges and 

mandarine hybrids (termed ‘‘tangerines’’

for regulatory purposes) to control 

Alternaria alternata. The applicant 

reported that only two fungicides are 

registered for use to control this 

pathogen and that neither provide 

commercially acceptable disease 

control. It was also stated that crop 

yields have been declining since 1999 

because of Alternaria alternata. EPA has 

authorized under FIFRA section 18 the 

use of boscalid (pre-mixed with 

pyraclostrobin as the product Pristine) 

on mandarins and mandarin hybrids for 

control of Alternaria alternata in 

California. After having reviewed the 

submission, EPA concurs that 

emergency conditions exist for this 

State. 

As part of its assessment of this 

emergency exemption, EPA assessed the 

potential risks presented by residues of 

boscalid in or on tangerines. In doing so, 

EPA considered the safety standard in 

section 408(b)(2) of the FFDCA, and 

EPA decided that the necessary 

tolerance under section 408(l)(6) of the 

FFDCA would be consistent with the 

safety standard and with FIFRA section 

18. Consistent with the need to move 

quickly on the emergency exemption in 

order to address an urgent non-routine 

situation and to ensure that the resulting 

food is safe and lawful, EPA is issuing 

this tolerance without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of the 

FFDCA. Although this tolerance will 

expire and is revoked on December 31, 

2008, under section 408(l)(5) of the 

FFDCA, residues of the pesticide not in 

excess of the amounts specified in the 

tolerance remaining in or on tangerines 

after that date will not be unlawful, 

provided the pesticide is applied in a 

manner that was lawful under FIFRA, 

and the residues do not exceed a level 

that was authorized by this tolerance at 

the time of that application. EPA will 

take action to revoke this tolerance 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

55288 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

Because this tolerance is being 

approved under emergency conditions, 

EPA has not made any decisions about 

whether boscalid meets EPA’s 

registration requirements for use on 

tangerines or whether a permanent 

tolerance for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this tolerance 

serves as a basis for registration of 

boscalid by a State for special local 

needs under FIFRA section 24(c). Nor 

does this tolerance serve as the basis for 

any State other than California to use 

this pesticide on this crop under section 

18 of FIFRA without following all 

provisions of EPA’s regulations 

implementing FIFRA section 18 as 

identified in 40 CFR part 166. For 

additional information regarding the 

emergency exemption for boscalid, 

contact the Agency’s Registration 

Division at the address provided under 

FOR FURTHER INFORMATION CONTACT. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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 the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day-26/p30948.htm. 

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

of the 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 boscalid and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of the 

FFDCA, for a time-limited tolerance for 

residues of the fungicide boscalid, 3- 

pyridinecarboxamide, 2-chloro-N-(4′- 

chloro[1,1′-biphenyl]-2-yl) in or on 

tangerines at 2.0 ppm. EPA’s assessment 

of the dietary exposures and risks 

associated with establishing the 

tolerance follows. 

A. 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 

endpoint. 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 

intra species differences. 

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 the appropriate UF (RfD = NOAEL/ 

UF). Where an additional safety factor is 

retained due to concerns unique to the 

FQPA, 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 FQPA Safety 

factor (SF). 

For non-dietary risk assessments 

(other than cancer) the UF is used to 

determine the level of concern (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 is expressed as 1 x 10-6 or one 

in a million). 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 boscalid used for human risk 

assessment is shown in the following 

Table 1: 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR BOSCALID FOR USE IN HUMAN RISK ASSESSMENT

Exposure Scenario Dose Used in Risk Assessment, 

UF 

Special FQPA SF and Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Acute Dietary No appropriate endpoint identified N/A N/A 

Chronic Dietary (All populations) NOAEL= 21.8 

UF = 100 

Chronic RfD = 0.218 mg/kg/day ..

FQPA SF = 1 

cPAD = chronic RfD/FQPA SF = 

0.218 mg/kg/day.

Chronic rat, carcinogenicity rat 

and 1–year dog studies 

LOAEL = 57–58 mg/kg/day 

based on liver and thyroid effects 

Incidental Oral (Short and intermediate term residential only) NOAEL= 21.8 mg/kg/day Residential LOC for MOE = 100 Chronic rat, carcinogenicity rat 

and 1–year dog studies 

LOAEL = 57–58 mg/kg/day 

based on liver and thyroid effects 

Dermal (All Durations) Oral study NOAEL=21.8 mg/kg/ 

day (dermal absorption rate = 

15%) 

Residential LOC for MOE = 100≤ Chronic rat, carcinogenicity rat 

and 1–year dog studies 

LOAEL = 57–58 mg/kg/day 

based on liver and thyroid effects 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55289 

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR BOSCALID FOR USE IN HUMAN RISK ASSESSMENT—

Continued 

Exposure Scenario Dose Used in Risk Assessment, 

UF 

Special FQPA SF and Level of 

Concern for Risk Assessment Study and Toxicological Effects 

Inhalation (All Durations) Oral study NOAEL= 21.8 mg/kg/ 

day (inhalation absorption rate 

= 100%) 

Residential LOC for MOE = 100 Chronic rat, carcinogenicity rat 

and 1–year dog studies 

LOAEL = 57–58 mg/kg/day 

based on liver and thyroid effects 

Cancer (oral, dermal, inhalation) Classification: ‘‘Suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic 

potential.’’

* The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established for residues of boscalid, 3- 

pyridinecarboxamide, 2-chloro-N-(4′- 

chloro[1,1′-biphenyl]-2-yl) in or on a 

wide variety of crops and animal 

commodities. Tolerances on primary 

crops range from 0.05 ppm on the 

Tuberous and Corm Vegetable Crop 

Subgroup (1C) to 30 ppm on peppermint 

and spearmint tops. Tolerances on 

rotational crops range from 0.05 ppm on 

several commodities to 8.0 ppm on 

grasses. Animal commodity tolerances 

range from 0.02 ppm for eggs to 0.35 

ppm for the meat byproducts of cattle, 

goats, horses, and sheep. Boscalid is a 

member of the carboxamide (anilide) 

class of compounds. In target crops and 

rotational crops, parent boscalid is the 

only residue of concern for both 

tolerance expression and risk 

assessment. In animal commodities, 

parent boscalid, a hydroxy metabolite, 

and the glucuronide of the hydroxy 

metabolite are the residues of concern 

for tolerance expression and risk 

assessment. In drinking water, parent 

boscalid is the only residue of concern 

for risk assessment. Risk assessments 

were conducted by EPA to assess 

dietary exposures from boscalid in food 

as follows: 

i. Acute exposure. Acute dietary risk 

assessments are performed for a fooduse pesticide if a toxicological study has 

indicated the possibility of an effect of 

concern occurring as a result of a one 

day or single exposure. As there were no 

toxic effects attributable to a single dose, 

an endpoint of concern was not 

identified to quantitate acute-dietary 

risk to the general population or to the 

subpopulation females 13–50 years old. 

Therefore, there is no acute reference 

dose (aRfD) or acute populationadjusted dose (aPAD) for the general 

population or females 13–50 years old. 

An acute aggregate risk assessment is 

not needed. 

ii. Chronic exposure. In conducting 

this chronic dietary risk assessment the 

Dietary Exposure Evaluation Model 

(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 chronic dietary 

exposure analysis was based on 

tolerance level residues and 100% crop 

treated assumptions. DEEM (Version 

7.81) default processing factors were 

used for some commodities. 

iii. Cancer. The Agency classified 

boscalid as having ‘‘suggestive evidence 

of carcinogenicity, but not sufficient to 

assess human carcinogenic potential.’’

The quantification of human cancer risk 

was therefore not conducted. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

boscalid in drinking water. Because the 

Agency does not have comprehensive 

monitoring data, drinking water 

concentration estimates are made by 

reliance on simulation or modeling 

taking into account data on the physical 

characteristics of boscalid. 

The Agency uses the First Index 

Reservoir Screening Tool (FIRST) or the 

Pesticide Root Zone/Exposure Analysis 

Modeling System (PRZM/EXAMS) to 

produce estimates of pesticide 

concentrations in an index reservoir. 

The screening concentration in 

groundwater (SCI-GROW) model is used 

to predict pesticide concentrations in 

shallow groundwater. For a screeninglevel assessment for surface water EPA 

will generally 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. While both FIRST and 

PRZM/EXAMS incorporate an index 

reservoir environment, the PRZM/ 

EXAMS model includes 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 

coarse screen for sorting out pesticides 

for which it is highly unlikely that 

drinking water concentrations would 

ever exceed human health levels of 

concern. 

Since the models used are considered 

to be screening tools in the risk 

assessment process, the Agency does 

not use estimated environmental 

concentrations (EECs) from these 

models to quantify drinking water 

exposure and risk as a percent of 

reference dose (%RfD) or percent of 

population adjusted dose (%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 boscalid they 

are further discussed in the aggregate 

risk sections below. 

Based on the FIRST and SCI-GROW 

models the EECs of boscalid for chronic 

exposures are estimated to be 26 parts 

per billion (ppb) for surface water and 

0.6 ppb for groundwater. 

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). 

55290 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

Boscalid is currently registered for use 

on golf courses. The boscalid label 

specifies that this product is intended 

for golf course use only, and not for use 

on residential turfgrass or turfgrass 

being grown for sale or other 

commercial use such as sod production. 

Although the label does not indicate 

that the product is applied by licensed 

or commercial applicators, it is 

acknowledged that the homeowner will 

not be applying the product to golf 

courses. Therefore, a risk assessment for 

residential handler exposure is not 

required. Boscalid is not packaged or 

marketed for home orchard use and, 

therefore, that use is not assessed. 

It has been determined that the 

potential exists for exposure to boscalid 

from entering areas previously treated 

with the fungicide. Based on the above 

discussion, there is only one potential 

non-occupational post-application 

scenario associated with boscalid for 

which risk needs to be assessed: adults 

and youths golfing. Duration of 

exposure is anticipated to be short-term. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

boscalid and any other substances and 

boscalid 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 boscalid 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 

concerning common mechanism 

determinations and procedures for 

cumulating effects from substances 

found to have a common mechanism on 

EPA’s website at http://www.epa.gov/ 

pesticides/cumulative/. 

C. Safety Factor for Infants and Children 

1. In general. Section 408 of the 

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 

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. 

2. Prenatal and postnatal sensitivity. 

A complete discussion of the prenatal/ 

postnatal sensitivity study was 

discussed in a final rule dated July 30, 

2003 (68 FR 44640) (FRL–7319–6). No 

new information has been received to 

change this information. 

At that time, the Agency concluded 

that there are no residual uncertainties 

for pre- and post-natal toxicity as the 

degree of concern is low for the 

susceptibility seen in the available 

studies, and the dose and endpoints 

selected for the overall risk assessments 

will address the concerns for the body 

weight effects seen in the offspring. 

Although the dose selected for overall 

risk assessments (21.8 mg/kg/day) is 

higher than the NOAELs in the 2- 

generation reproduction study (10.1 mg/ 

kg/day) and the developmental 

neurotoxicity study (14 mg/kg/day), 

these differences are considered to be an 

artifact of the dose selection process in 

these studies. For example, there is a 

tenfold difference between the LOAEL 

(106.8 mg/kg/day) and the NOAEL (10.1 

mg/kg/day) in the 2-generation 

reproduction study. A similar pattern 

was seen with regard to the 

developmental neurotoxicity study, 

where there is also a tenfold difference 

between the LOAEL (147 mg/kg/day) 

and the NOAEL (14 mg/kg/day). There 

is only a 2- to 3-fold difference between 

the LOAEL (57 mg/kg/day) and the 

NOAEL (21.8 mg/kg/day) in the critical 

study used for risk assessment. Because 

the gap between the NOAEL and LOAEL 

in the 2-generation reproduction and 

developmental neurotoxicity studies 

was large and the effects at the LOAELs 

were minimal, the true NOAEL was 

probably considerably higher. 

Therefore, the selection of the NOAEL 

of 21.8 mg/kg/day from the 1–year dog 

study is conservative and appropriate 

for the overall risk assessments. In 

addition, the endpoints for risk 

assessment are based on thyroid effects 

seen in multiple species (mice, rats and 

dogs) and after various exposure 

durations (subchronic and chronic 

exposures) which were not observed at 

the LOAELs in either the 2-generation 

reproduction or the developmental 

neurotoxicity studies. Based on these 

data, the Agency concluded that there 

are no residual uncertainties for preand post-natal toxicity. 

3. Conclusion. There is a complete 

toxicity database for boscalid and 

exposure data are complete or are 

estimated based on data that reasonably 

accounts for potential exposures. There 

is no evidence of susceptibility 

following in utero exposure to rats and 

there is low concern and no residual 

uncertainties in the developmental 

toxicity study in rabbits, in the 2- 

generation reproduction study or in the 

developmental neurotoxicity study after 

establishing toxicity endpoints and 

traditional uncertainty factors to be used 

in the risk assessment. Based on these 

data and conclusions, EPA reduced the 

FQPA safety factor to 1X. 

D. Aggregate Risks and Determination of 

Safety 

To estimate total aggregate exposure 

to a pesticide from food, drinking water, 

and residential uses, the Agency 

calculates DWLOCs which are used as a 

point of comparison against the model 

estimates of a pesticide’s concentration 

in water (EECs). 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 + chronic non-dietary, nonoccupational 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 USEPA 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. 

When EECs for surface water and 

groundwater are less than the calculated 

DWLOCs, the Office of Pesticide 

Programs (OPP) concludes with 

reasonable certainty that exposures to 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55291 

boscalid 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 boscalid on drinking water as 

a part of the aggregate risk assessment 

process. 

1. Acute risk. As there were no toxic 

effects attributable to a single dose of 

boscalid, an endpoint of concern was 

not identified to quantitate acute dietary 

risk. As a result, an acute aggregate risk 

assessment is not needed. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to boscalid from food will 

utilize 7% of the cPAD for the U.S. 

population, 16% of the cPAD for all 

infants (<1 year old) and 26% of the 

cPAD for children 1 to 2 years old. 

There are no residential uses for 

boscalid that result in chronic 

residential exposure to boscalid. In 

addition, despite the potential for 

chronic dietary exposure to boscalid in 

drinking water, after calculating 

DWLOCs and comparing them to 

conservative model of boscalid in 

surface and ground water, EPA does not 

expect the aggregate exposure to exceed 

100% of the cPAD, as shown in Table 

2 of this unit: 

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON-CANCER) EXPOSURE TO BOSCALID

Population Subgroup cPAD mg/ 

kg/day 

% cPAD 

(Food) 

Surface 

Water 

EDWC 

(ppb) 

Ground 

Water 

EDWC 

(ppb) 

Chronic 

DWLOC 

(ppb) 

U.S. Population 0.218 7 26 0.63 7,100 

All Infants (<1 year old) 0.218 16 26 0.63 1,800 

Children 1–2 years 0.218 26 26 0.63 1,600 

Females 13–49 0.218 5 26 0.63 6,200 

3. Short-term risk. The short-term 

aggregate risk assessment takes into 

account average exposure estimates 

from dietary consumption of boscalid 

(food and drinking water) and nonoccupational uses (golf courses). 

Postapplication exposures from the 

proposed use on golf courses is 

considered short-term, and applies to 

adults and youths. Therefore, a shortterm aggregate risk assessment was 

conducted. Since all endpoints are from 

the same study, exposures from 

different routes can be aggregated. Table 

3 summarizes the results. The MOE 

from food and non-occupational uses is 

1,400, and the calculated short-term 

DWLOC is 6,100 ppb. Compared to the 

surface and groundwater EDWCs, the 

DWLOCs are considerably greater. 

Therefore, short-term aggregate risk does 

not exceed EPA’s level of concern. The 

MOE and DWLOC are considered to be 

representative for youth because youth 

and adults possess similar body surface 

area to weight ratios, and because the 

dietary exposure for youth (13–19 years 

old) is less than that of the general U.S. 

population. 

TABLE 3.—AGGREGATE RISK ASSESSMENT FOR SHORT-TERM EXPOSURE TO BOSCALID

Population 

Short-Term Scenario 

NOAEL 

mg/kg/ 

day 

Target 

MOE 

Max Exposure 

mg/kg/ 

day 

Average 

Food Exposure mg/kg/ 

day 

Residential Exposure mg/ 

kg/day 

Aggregate 

MOE 

(food and 

residential) 

Max 

Water Exposure 

mg/kg/ 

day 

Ground 

Water 

EDWC 

(ppb) 

Surface 

Water 

EDWC 

(ppb) 

ShortTerm 

DWLOC 

(ppb) 

U.S 21.8 100 0.218 0.014631 0.0008 1,400 0.2026 0.6 26 6,100 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account non-dietary, nonoccupational exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). As 

no intermediate-term non-occupational 

exposures to boscalid are anticipated, an 

intermediate-term aggregate risk 

assessment is not needed. 

5. Aggregate cancer risk for U.S. 

population. EPA’s review of toxicity 

data has resulted in a classification of 

boscalid as having ‘‘suggestive evidence 

of carcinogenicity, but not sufficient to 

assess human carcinogenic potential.’’

Thus, a quantification of human cancer 

risk has not been performed. 

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 boscalid 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(example—gas chromatography) 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 is neither a Codex proposal, nor 

a Canadian or Mexican maximum 

residue limit for residues of boscalid on 

tangerines. Therefore harmonization is 

not an issue. 

55292 Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 

VI. Conclusion 

Therefore, the tolerance is established 

for residues of the fungicide boscalid, 3- 

pyridinecarboxamide, 2-chloro-N-(4′- 

chloro[1,1′-biphenyl]-2-yl) in or on 

tangerines at 2.0 ppm. 

VII. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the 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 the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the 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 the FFDCA, as was 

provided in the old sections 408 and 

409 of the 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–2005–0259 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 21, 2005. 

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 issue(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 VII.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 the docket ID 

number OPP–2005–0259, to: Public 

Information and Records Integrity 

Branch, Information Technology and 

Resource Management 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 e-mail 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 

issue(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

VIII. Statutory and Executive Order 

Reviews 

This final rule establishes a timelimited tolerance under section 408 of 

the FFDCA. 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 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 FIFRA 

section 18 exemption under section 408 

of the 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 

Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Rules and Regulations 55293 

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 the 

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. 

IX. 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 13, 2005 

Meredith F. Laws, 

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 180.589 is amended by 

adding text to paragraph (b) after the 

paragraph heading to read as follows: 

§ 180.589 Boscalid; tolerances for 

residues. 

* * * * * 

(b) * * * Time-limited tolerances are 

established for residues of the fungicide 

boscalid, 3-pyridinecarboxamide, 2- 

chloro-N-(4′-chloro[1,1 ′-biphenyl]-2-yl) 

in connection with use of the pesticide 

under section 18 emergency exemptions 

granted by EPA. These tolerances will 

expire and are revoked on the dates 

specified in the following table: 

Commodity Parts per 

million 

Expiration/ 

Revocation 

Date 

Tangerine .......... 2.0 12/31/08 

* * * * * 

[FR Doc. 05–18830 Filed 9–20–05; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[OPP–2005–0069; FRL–7737–3] 

Inert Ingredients; Revocation of 34 

Pesticide Tolerance Exemptions for 31 

Chemicals 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: EPA is revoking 34 

exemptions from the requirement of a 

tolerance that are associated with 31 

inert ingredients because these 

substances are no longer contained in 

active Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA) pesticide 

product registrations. These ingredients 

are subject to reassessment by August 

2006 under section 408(q) of the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

as amended by the Food Quality 

Protection Act of 1996 (FQPA). The 34 

tolerance exemptions are considered 

‘‘reassessed’’ for purposes of FFDCA’s 

section 408(q). 

DATES: This regulation is effective 

September 21, 2005. Objections and 

requests for hearings must be received 

on or before November 21, 2005. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit XI. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under docket 

identification (ID) number OPP–2005–

0069. 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: 

Karen Angulo, Registration Division 

(7505C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 306–0404; e-mail address: 

angulo.karen@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 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 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