57550 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Rules and Regulations

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–301042; FRL–6741–1]

RIN 2070–2078

Mefenoxam; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time–limited tolerance for mefenoxam

in or on canola. This action is in

response to EPA’s granting of an

emergency exemption under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on canola. This regulation

establishes a maximum permissible

level for residues of mefenoxam in this

food commodity. The tolerance will

expire and is revoked on December 31,

2001.

DATES: This regulation is effective

September 25, 2000. Objections and

requests for hearings, identified by

docket control number OPP–301042,

must be received by EPA on or before

November 24, 2000.

ADDRESSES: Written objections and

hearing requests may be submitted by

mail, in person, or by courier. Please

follow the detailed instructions for each

method as provided in Unit VII. of the

SUPPLEMENTARY INFORMATION. To ensure

proper receipt by EPA, your objections

and hearing requests must identify

docket control number OPP–301041 in

the subject line on the first page of your

response.

FOR FURTHER INFORMATION CONTACT: By

mail: Dan Rosenblatt, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 1200 Pennsylvania Ave., NW.,

Washington, DC 20460; telephone

number:(703) 308–9375 and e-mail

address: rosenblatt.dan@;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 categories and entities may

include, but are not limited to:

Categories NAICS codes Examples of Potentially Affected Entities

Industry 111 Crop production

112 Animal production

311 Food manufacturing

32532 Pesticide manufacturing

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 the table could also

be affected. The North American

Industrial Classification System

(NAICS) codes have been provided to

assist you and others in determining

whether or not this action might apply

to certain entities. If you have questions

regarding the applicability of this action

to a particular entity, consult the person

listed under FURTHER INFORMATION

CONTACT.

B. How Can I Get Additional

Information, Including Copies of This

Document and Other Related

Documents?

1. Electronically. You may obtain

electronic copies of this document, and

certain other related documents that

might be available electronically, from

the EPA Internet Home Page at http://

www.epa.gov/. To access this

document, on the Home Page select

‘‘Laws and Regulations,’’ ‘‘Regulations

and Proposed Rules,’’ and then look up

the entry for this document under the

‘‘Federal Register—Environmental

Documents.’’ You can also go directly to

the Federal Register listings at http://

www.epa.gov/fedrgstr/.

2. In person. The Agency has

established an official record for this

action under docket control number

OPP–301042. The official record

consists of the documents specifically

referenced in this action, and other

information related to this action,

including any information claimed as

Confidential Business Information (CBI).

This official record includes the

documents that are physically located in

the docket, as well as the documents

that are referenced in those documents.

The public version of the official record

does not include any information

claimed as CBI. The public version of

the official record, which includes

printed, paper versions of any electronic

comments submitted during an

applicable comment period is available

for inspection in the Public Information

and Records Integrity Branch (PIRIB),

Rm. 119, Mall #2, 1921 Jefferson Davis

Hwy., Arlington, VA, from 8:30 a.m. to

4 p.m., Monday through Friday,

excluding legal holidays. The PIRIB

telephone number is (703) 305–5805.

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 the seed

treatment mefenoxam, in or on canola at

0.05 part per million (ppm). This

tolerance will expire and is revoked on

December 31, 2001. 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 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) 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

Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Rules and Regulations 57551

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) 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 (FQPA). EPA has established

regulations governing such emergency

exemptions in 40 CFR part 166.

III. Emergency Exemption for

mefenoxam on canola and FFDCA

Tolerances

EPA has authorized under FIFRA

section 18 the use of mefenoxam on

canola seed for control of seed borne

diseases in canola seed. EPA was

petitioned for the use of a product that

contains mefenoxam as one of its active

ingredients under section 18 of FIFRA.

After having reviewed the submission,

EPA granted the emergency use.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

mefenoxam in or on canola. In doing so,

EPA considered the safety standard in

FFDCA section 408(b)(2), and EPA

decided that the necessary tolerance

under FFDCA section 408(l)(6) 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). Although

this tolerance will expire and is revoked

on December 31, 2001, under FFDCA

section 408(l)(5), residues of the

pesticide not in excess of the amounts

specified in the tolerance remaining in

or on canola 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.

Because this tolerance is being

approved under emergency conditions,

EPA has not made any decisions about

whether mefenoxam meets EPA’s

registration requirements for use on

canola 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

mefenoxam by a State for special local

needs under FIFRA section 24(c). Nor

does this tolerance serve as the basis for

any State to use this pesticide on this

crop under section 18 of FIFRA without

following all provisions of EPA’s

regulations implementing section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemption for mefenoxam,

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 and a

complete description of the risk

assessment process, see the final rule on

Bifenthrin Pesticide Tolerances

November 26, 1997 (62 FR 62961) (FRL–

5754–7).

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

EPA has reviewed the available

scientific data and other relevant

information in support of this action.

EPA has sufficient data to assess the

hazards of mefenoxam and to make a

determination on aggregate exposure,

consistent with section 408(b)(2), for a

time–limited tolerance for mefenoxam

in or on canola at 0.05 ppm.

Mefenoxam is predominantly the R–

enantiomer (94:3 ratio of R– to S–

enantiomers) of the racemic mixture of

the fungicide metalaxyl. Metalaxyl is a

50:50 combination of the R– and S–

enantiomers. In reaching regulatory

decisions on mefenoxam, EPA reviewed

data which bridges environmental fate,

chemistry, and toxicology studies

between metalaxyl and mefenoxam.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Endpoints

The dose at which no observed

adverse effects are observed (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 (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.

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.

The doses and toxicological endpoints

selected and the LOC for margins of

exposure for various exposure senarios

are summarized in the following Table

1:

57552 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Rules and Regulations

TABLE 1.—SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR MEFENOXAM AND METALAXYL FOR USE IN HUMAN

RISK ASSESSMENT

Exposure scenario Dose used in risk

assessment, UF

FQPA SF* and level of concern for risk assessment Study and toxicological effects

Acute dietary females 13–50

years of age

None None

Acute dietary general population

including infants and children

None None

Chronic dietary all populations NOAEL = 7.4 mg/kg/day UF

= 100 Chronic RfD =

0.074 mg/kg/day

FQPA SF = 3 cPAD =

chronic RfD FQPA SF =

0.025 mg/kg/day

6 month feeding study – dogs LOAEL = 32.4

mg/kg/day based on increased alkaline phosphatase and increased absolute and relative

liver weight.

Short–term dermal (1 to 7 days)

(1 to 7 days (Residential)

None None

Interme diate–term Dermal (1

week to several months) (Residential)

None. None.

Long–term dermal (several

months to lifetime) (Residential)

dermal (or oral) study

NOAEL= 7.4 mg/kg/day

(dermal absorption rate =

30% when appropriate)

LOC for MOE = 100 (Residential)6 month feeding study – dogs LOAEL = 32.4

mg/kg/day based on increased alkaline phosphatase and increased absolute and relative

liver weight.

Short–term Inhalation (1 to 7

days) (Residential)

None None

Interme diate–term Inhalation (1

week to several months) (Residential)

None None

Long–term Inhalation (several

months to lifetime) (Residential)

None None

Cancer (oral, dermal, inhalation) The carcinogenicity study in mice and combined

chronic toxicity/carcinogenicity study in rats

suggest metalaxyl is best considered for EPA

Group E (‘‘not likely to be carcinogenic in humans’’)

The reference to the FQPA Safety

Factor refers to any additional safety

factor retained due to concerns unique

to the FQPA.

B. Exposure Assessment

1. Dietary exposure from food and

feed uses. Tolerances that permit

residues for other registered uses of

metalaxyl and mefenoxam have been

published at 40 CFR 180.408 on a

variety of raw agricultural commodities.

Currently, there are no established

tolerances for mefenoxam. Risk

assessments in support of this action

were conducted by EPA to assess

dietary exposures from all registered

uses of metalaxyl and mefenoxam in

food based on the tolerances established

at 40 CFR 180.408 as follows:

i. Acute exposure. Acute dietary risk

assessments are performed for a food–

use pesticide if a toxicological study has

indicated the possibility of an effect of

concern occurring as a result of a one

day or single exposure. EPA did not

conduct an acute exposure risk

assessment for mefenoxam. The

rationale for this decision is that the

laboratory data on metalaxyl and

mefenoxam suggest that no toxic effect

could be attributed to a single oral

exposure. Therefore, no endpoints were

selected for this exposure duration and

no risk assessment was conducted.

ii. Chronic exposure. In conducting

this chronic dietary risk assessment the

Dietary Exposure Evaluation Model

(DEEM) analysis evaluated the

individual food consumption as

reported by respondents in the USDA

1989–1992 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: The

risk assessment used the published

tolerances for metalaxyl plus the

tolerance associated with the requested

exemption. Residues were assumed to

be at tolerance levels. The use of

tolerance level residues is considered a

conservative assumption. For

agricultural commodities, where such

data were available, percent crop treated

data were also used.

iii. Cancer. EPA bridged data on the

carcinogenicity of metalaxyl from a

carcinogenicity study in mice and a

combined chronic toxicity and

carcinogenicity study in rats to assess

the carcinogenicity of mefenoxam.

Based on these data, mefenoxam is

considered ‘‘not likely to be

carcinogenic in human.’’ This

corresponds to category ‘‘E’’ in EPA’s

cancer classification system. Thus, an

aggregate cancer risk assessment was

not conducted for this action.

iv. Anticipated residue and percent

crop treated information.

Section 408(b)(2)(F) states that the

Agency may use data on the actual

percent of food treated for assessing

chronic dietary risk only if the Agency

can make the following findings:

Condition 1, that the data used are

reliable and provide a valid basis to

show what percentage of the food

derived from such crop is likely to

contain such pesticide residue;

Condition 2, that the exposure estimate

does not underestimate exposure for any

significant sub population group; and

Condition 3, if data are available on

pesticide use and food consumption in

a particular area, the exposure estimate

does not understate exposure for the

population in such area. In addition, the

Agency must provide for periodic

evaluation of any estimates used. To

provide for the periodic evaluation of

the estimate of percent crop treated

(PCT) as required by section

Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Rules and Regulations 57553

408(b)(2)(F), EPA may require

registrants to submit data on PCT.

The Agency used percent crop treated

(PCT) information as follows.

The Agency believes that the three

conditions listed above have been met.

With respect to Condition 1, PCT

estimates are derived from Federal and

private market survey data, which are

reliable and have a valid basis. EPA uses

a weighted average PCT for chronic

dietary exposure estimates. This

weighted average PCT figure is derived

by averaging State–level data for a

period of up to 10 years, and weighting

for the more robust and recent data. A

weighted average of the PCT reasonably

represents a person’s dietary exposure

over a lifetime, and is unlikely to

underestimate exposure to an individual

because of the fact that pesticide use

patterns (both regionally and nationally)

tend to change continuously over time,

such that an individual is unlikely to be

exposed to more than the average PCT

over a lifetime. For acute dietary

exposure estimates, EPA uses an

estimated maximum PCT. The exposure

estimates resulting from this approach

reasonably represent the highest levels

to which an individual could be

exposed, and are unlikely to

underestimate an individual’s acute

dietary exposure. The Agency is

reasonably certain that the percentage of

the food treated is not likely to be an

underestimation. As to conditions 2 and

3, regional consumption information

and consumption information for

significant sub populations is taken into

account through EPA’s computer–based

model for evaluating the exposure of

significant sub populations including

several regional groups. Use of this

consumption information in EPA’s risk

assessment process ensures that EPA’s

exposure estimate does not understate

exposure for any significant sub

population group and allows the

Agency to be reasonably certain that no

regional population is exposed to

residue levels higher than those

estimated by the Agency. Other than the

data available through national food

consumption surveys, EPA does not

have available information on the

regional consumption of food to which

metalaxyl or mefenoxam may be applied

in a particular area.

2. Dietary exposure from drinking

water. The Agency lacks sufficient

monitoring exposure data to complete a

comprehensive dietary exposure

analysis and risk assessment for

metalaxyl or mefenoxam 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 metalaxyl

and mefenoxam.

The Agency uses the Generic

Estimated Environmental Concentration

(GENEEC) or the Pesticide Root Zone/

Exposure Analysis Modeling System

(PRZM/EXAMS) to estimate pesticide

concentrations in surface water and

SCI–GROW, which predicts pesticide

concentrations in ground water. In

general, EPA will use GENEEC (a tier 1

model) before using PRZM/EXAMS (a

tier 2 model) for a screening–level

assessment for surface water. The

GENEEC model is a subset of the PRZM/

EXAMS model that uses a specific high–

end runoff scenario for pesticides.

GENEEC incorporates a farm pond

scenario, while PRZM/EXAMS

incorporate an index reservoir

environment in place of the previous

pond scenario. 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 %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 mefenoxam

they are further discussed in the

aggregate risk sections below.

Since no acute dietary endpoint has

been identified, no acute exposure

estimated environmental concentrations

(EECs) for metalaxyl and mefenoxam in

surface water and ground water were

calculated. The generic EECs for chronic

exposures are estimated to be 63 ppb for

surface water, based on the GENEEC

model, and 5 ppb for ground water,

based on the SCI–GROW model.

3. From non–dietary exposure. The

term ‘‘residential exposure’’ is used in

this document to refer to non–

occupational, non–dietary exposure

(e.g., for lawn and garden pest control,

indoor pest control, termiticides, and

flea and tick control on pets).

Metalaxyl and mefenoxam are

currently registered for use on the

following residential non–dietary sites:

turf and certain ornamental sites. For

short–term and intermediate–term

exposures, no toxicological endpoint

was selected. Thus, no exposure

assessment is needed. Chronic, non–

dietary, exposure is considered to be

180 days or longer. This sort of exposure

duration is not expected to result in

association with the requested section

18 exemption. Similarly, chronic non–

dietary exposures are not expected from

the use of other registered metalaxyl and

mefenoxam products. Thus, a

quantitative risk assessment for chronic

residential exposures was not

performed.

4. Cumulative exposure to substances

with a common mechanism of toxicity.

Section 408(b)(2)(D)(v) requires that,

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

EPA does not have, at this time,

available data to determine whether

metalaxyl and mefenoxam has a

common mechanism of toxicity with

other substances or how to include this

pesticide in a cumulative risk

assessment. Unlike other pesticides for

which EPA has followed a cumulative

risk approach based on a common

mechanism of toxicity, metalaxyl and

mefenoxam 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 metalaxyl and mefenoxam

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 final rule for

Bifenthrin Pesticide Tolerances

November 26, 1997 (62 FR 62961).

C. Safety Factor for Infants and Children

1. Safety factor for infants and

children—i. In general. FFDCA section

408 provides that EPA shall apply an

additional tenfold margin of safety for

infants and children in the case of

57554 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Rules and Regulations

threshold effects to account for prenatal

and postnatal toxicity and the

completeness of the data base 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.

ii. Developmental toxicity studies.

EPA has determined that there is

adequate information about prenatal

developmental toxicity to conclude that

mefenoxam and metalaxyl do not pose

a risk of increased sensitivity due to in

utero exposure.

iii. Reproductive toxicity study. The

2–generation reproduction study is

unacceptable because no offspring or

parental toxicity was demonstrated at

any dose level. Therefore, reproductive

toxicity is currently considered a data

gap.

iv. Prenatal and postnatal sensitivity.

Based on reviewed laboratory data,

there is no indication of increased

sensitivity as a result of in utero

exposure. There are no data gaps

relative to in utero exposure. The 2–

generation reproduction study is not

considered to be acceptable because

toxicity is absent in both offspring and

parents at any dose level. This

limitation makes it difficult to fully

assess the effects of exposure to young

animals following early postnatal

exposure.

v. Conclusion. In considering all of

the information in this area, EPA chose

to reduce the infant and children’s

safety factor to 3x for this action. There

are several factors underlying this

decision: (1) There are no data gaps for

this assessment of effects following in

utero exposure; (2) there is no

indication of increased sensitivity of

rats and or rabbits to in utero exposure

to mefenoxam or metalaxyl and ; (3) the

exposure assessment will not

underestimate the potential dietary and

non–dietary exposure resulting from the

use of mefenoxam. However, since the

reproductive toxicity study is

unacceptable the FQPA safety factor is

3x.

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, non–

occupational 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: 2L/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

ground water are less than the

calculated DWLOCs, OPP concludes

with reasonable certainty that exposures

to metalaxyl and mefenoxam 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

metalaxyl and mefenoxam on drinking

water as a part of the aggregate risk

assessment process.

1. Acute risk. As previously stated, no

toxic effect was associated with a single

dose or exposure to metalaxyl and

mefenoxam in laboratory studies. Thus,

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 metalaxyl and

mefenoxam from food will utilize 10%

of the cPAD for the U.S. population,

11% of the cPAD for non–nursing

infants and 19% of the cPAD for

children 1–6 years. Based on the use

pattern, chronic residential exposure to

residues of the metalaxyl and

mefenoxam is not expected. In addition,

despite the potential for chronic dietary

exposure to these pesticides in drinking

water, after calculating the DWLOCs

and comparing them to conservative

model estimated environmental

concentrations of metalaxyl and

mefenoxam in surface and ground

water, EPA does not expect the

aggregate exposure to exceed 100% of

the cPAD, as shown in the following

Table 2:

TABLE 2.—AGGREGATE RISK ASSESSMENT FOR CHRONIC (NON–CANCER) EXPOSURE TO MEFENOXAM

Population Subgroup cPAD mg/

kg/day

cPAD

(Food)

Surface

water EEC

(ppb)

Ground

water EEC

(ppb)

Chronic

DWLOC

(ppb)

U.S. population 0.25 10% 63 ppb 5 ppb 780

children 1–6 years 0.25 19% 63 ppb 4.95 ppb 200

non–nursing infants 0.25 11% 63 ppb 4.95 ppb 220

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).

Though residential exposure could

occur with the use of metalaxyl and

mefenoxam, no toxicological effects

have been identified for short–term

toxicity. Therefore, the aggregate risk is

Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Rules and Regulations 57555

the sum of the risk from food and water,

which were previously addressed.

4. Intermediate–term risk.

Intermediate–term aggregate exposure

takes into account non–dietary, non–

occupational exposure plus chronic

exposure to food and water (considered

to be a background exposure level).

Though residential exposure could

occur with the use of metalaxyl and

mefenoxam, no toxicological effects

have been identified for intermediate–

term toxicity. Therefore, the aggregate

risk is the sum of the risk from food and

water, which were previously

addressed.

5. Aggregate cancer risk for U.S.

population. An aggregate cancer risk

was not conducted for this action.

Available data on metalaxyl and

mefenoxam indicate that the chemical is

considered ‘‘not likely to be

carcinogenic in humans.’’

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 mefenoxam

residues.

V. Other Considerations

A. Analytical Enforcement Methodology

Enforcement methodology to enforce

residues associated with this use on

agricultural and animal commodities for

metalaxyl is available in the Pesticide

Analytical Manual. A unique method

for mefenoxam, predominantly the R–

enantiomer of metalaxyl, is under

review at this time.

B. International Residue Limits

At this time, there are no Codex,

Canadian, or Mexican residue tolerances

for mefenoxam on canola. However,

EPA is coordinating with the Canadian

pesticide regulatory agency on this

matter where a permit for the use of

Helix on canola is under review. Thus,

this time–limited tolerance for

mefenoxam is expected to be compatible

with future actions by Canadian officials

on this matter.

C. Magnitude of Residues

Residues of mefenoxam (R)-2-[(2,6-

dimethylphenyl)-methoxyacetylaminopropionic acid methyl ester and its

metabolites containing the 2,6-

dimethylaniline moiety, and N-(2-

hydroxymethyl-6-methylphenyl)-N-

(methoxyacetyl)-alanine methyl ester

each expressed as mefenoxam

equivalents are not expected to exceed

0.05 ppm in/on canola seed or its

processed commodities (meal and

refined oil) as a result of this section 18

use.

Secondary residues of mefenoxam in

animal commodities as a result of this

section 18 use are not expected to

exceed the established tolerance for

metalaxyl: 0.05 ppm for meat and meat

byproducts (except kidney and liver) of

cattle, goats, hogs, horses, poultry, and

sheep; 0.4 ppm for fat, kidney, and liver

of cattle, goats, hogs, horses, poultry,

and sheep; 0.02 ppm for milk; and 0.05

ppm for eggs.

VI. Conclusion

Therefore, the tolerance is established

for mefenoxam,, in or on canola at 0.05

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 of 1996, EPA will

continue to use those procedures, with

appropriate adjustments, until the

necessary modifications can be made.

The new section 408(g) 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), as was provided in the

old FFDCA sections 408 and 409.

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 control

number OPP–301042 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 24, 2000.

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 (1900), Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. You

may also deliver your request to the

Office of the Hearing Clerk in Rm. C400,

Waterside Mall, 401 M St., SW.,

Washington, DC 20460. 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) 260–4865.

2. Tolerance fee payment. If you file

an objection or request a hearing, you

must also pay the fee prescribed by 40

CFR 180.33(i) or request a waiver of that

fee pursuant to 40 CFR 180.33(m). You

must mail the fee to: EPA Headquarters

Accounting Operations Branch, Office

of Pesticide Programs, P.O. Box

360277M, Pittsburgh, PA 15251. Please

identify the fee submission by labeling

it ‘‘Tolerance Petition Fees.’’

EPA is authorized to waive any fee

requirement ‘‘when in the judgement of

the Administrator such a waiver or

refund is equitable and not contrary to

the purpose of this subsection.’’ For

additional information regarding the

waiver of these fees, you may contact

James Tompkins by phone at (703) 305–

5697, by e-mail at

tompkins.jim@epa.gov, or by mailing a

request for information to Mr. Tompkins

at Registration Division (7505C), Office

of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

If you would like to request a waiver

of the tolerance objection fees, you must

mail your request for such a waiver to:

James Hollins, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460.

3. 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 Unit I.B.2. Mail your

copies, identified by the docket control

number OPP–301042, to: Public

Information and Records Integrity

Branch, Information Resources and

Services Division (7502C), Office of

57556 Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Rules and Regulations

Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania

Ave., NW., Washington, DC 20460. In

person or by courier, bring a copy to the

location of the PIRIB described in Unit

I.B.2. 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 file

format 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).

VIII. Regulatory Assessment

Requirements

This final rule establishes a time

limited tolerance under FFDCA section

408. The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review October 4, 1993

(58 FR 51735). 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

prior consultation as specified by

Executive Order 13084, entitled

Consultation and Coordination with

Indian Tribal Governments May 19,

1998, (63 FR 27655) special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low–Income

Populations February 16, 1994 (59 FR

7629) or require OMB review or any

Agency action under Executive Order

13045, entitled Protection of Children

from Environmental Health Risks and

Safety Risks April 23, 1997 (62 FR

19885). 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 FFDCA

section 408, 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 August 10, 1999 (64 FR

43255). 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 FFDCA section 408(n)(4).

IX. Submission to Congress and the

Comptroller General

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 11, 2000.

Susan B. Hazen,

Acting 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 180.546 is added to read as

follows:

§ 180.546 Mefenoxam; tolerances for

residues.

(a) General. [Reserved]

(b) Section 18 emergency exemptions.

A time–limited tolerance is established

for mefenoxam (R)-2-(2,6-

dimethylphenyl)-methoxyacetylaminopropionic acid methyl ester and its

metabolites containing the 2,6-

dimethylaniline moiety, and N-(2-

hydroxymethyl-6-methylphenyl)-N-

(methoxyacetyl)-alanine methyl ester,

each expressed as mefenoxam

equivalents in or on the following

commodities food in connection with

the use of the pesticide under a section

18 exemption granted by EPA. The

time–limited tolerance will expire on

the date specified in the following

Table:

Commodity Parts per million Expiration/revocation date

Canola 0.05 12/31/01

Federal Register / Vol. 65, No. 186 / Monday, September 25, 2000 / Rules and Regulations 57557

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertant residues.

[Reserved]

[FR Doc. 00–24576 Filed 9–22–00; 8:45 am]

BILLING CODE 6560–50–S

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 15

[ET Docket 99–231; FCC 00–312]

Spread Spectrum Devices

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: This document amends the

Commission’s rules for frequency

hopping spread spectrum devices in the

2.4 GHz band (2400–2483.5 MHz). The

rules were amended to allow frequency

hopping spread spectrum transmitters

operating in the band to use a minimum

of 15 hopping channels, spanning a total

of 75 MHz. The new rules will allow for

hopping channels up to 5 MHz wide.

The wider bandwidths will permit these

systems to provide higher data speeds,

thereby enabling the development of

new and improved consumer products

such as wireless computer local area

networks and wireless cable modems.

DATES: Effective September 25, 2000.

FOR FURTHER INFORMATION CONTACT: Neal

L. McNeil, Office of Engineering and

Technology, (202) 418–2408, TTY (202)

418–2989, e-mail: nmcneil@fcc.gov.

SUPPLEMENTARY INFORMATION: This is a

summary of the Commission’s First

Report and Order, ET Docket 99–231,

FCC 00–312 adopted August 24, 2000

and released August 31, 2000. The full

text of this document is available for

inspection and copying during regular

business hours in the FCC Reference

Center, (Room CY–A257) 445 12th

Street SW., Washington, DC. The

complete text of this document also may

be purchased from the Commission’s

duplication contractor, International

Transcription Service, Inc., (202) 857–

3800, 1231 20th Street, NW,

Washington, DC 20036.

Summary of Report and Order

1. The First Report and Order

(‘‘R&O’’) amends the Commission’s

rules for frequency hopping spread

spectrum devices in the 2.4 GHz band

(2400–2483.5 MHz). The rules were

amended to allow frequency hopping

spread spectrum transmitters operating

in the band to use a minimum of 15

hopping channels, spanning a total of 75

MHz. The new rules will allow for

hopping channels up to 5 MHz wide.

The wider bandwidths will permit these

systems to provide higher data speeds,

thereby enabling the development of

new and improved consumer products

such as wireless computer local area

networks and wireless cable modems.

2. The Commission initiated a Notice

of Proposed Rule Making (‘‘Notice’’), 64

FR 38877, July 20, 1999, in this

proceeding in response to a letter filed

by the Home RF Working Group (‘‘Home

RF’’) requesting that part 15 spread

spectrum systems operating in the 2.4

GHz band be permitted to use

bandwidths of up to 5 MHz. The Notice

proposed rule changes consistent with

the request of the Home RF Working

Group. Specifically, the Notice

proposed to allow systems to operate

with bandwidths of up to 3 MHz or 5

MHz in the 2.4 GHz band. Under the

proposal, the systems would utilize 75

hopping channels. Output power would

be reduced in proportion to the increase

in bandwidth over 1 MHz. For example,

systems with 3 MHz bandwidths would

operate with output power of no more

than 320 mW and channel occupancy

time no greater than 0.05 second per

hop. Each of the 75 channels would be

used at least once during a 3.75 second

period. Like existing 1 MHz systems, the

average time of occupancy on any

channel would not be greater than 0.4

second within a 30 second period.

Under the proposal, systems using 5

MHz bandwidths would operate with

output power of no more than 200 mW

and channel occupancy time of no

greater than 0.02 second per hop. Each

of the 75 hopping channels would be

used at least once during a 1.5 second

period. Again, the average occupancy

time on any channel would remain 0.4

second or less per 30 second period.

3. Opponents of the proposed rules

expressed a number of concerns. For

example, the Wireless Ethernet

Compatibility Alliance (‘‘WECA’’) filed

comments October 14, 1999, asserting

that devices operating under the

proposed new rules will not be able to

achieve the claimed higher data rates

because they will be more prone to

multipath and interference problems.

The opponents therefore assert the

Home RF proposal will have little or no

public benefit. The opponents are

concerned that, under the Notice, wide

band frequency hopping systems could

use overlapping hopping channels.

Intersil and Lucent submitted technical

analyses and test data claiming to show

that interference from partially

overlapping channels is more

detrimental to frequency hopping

systems than the first-adjacent or cochannel interference. According to

Intersil, wide band frequency hopping

systems employing overlapping

channels will experience a greater level

of mutual interference than existing

systems that use 1 MHz bandwidths. To

compensate, they assert that the systems

would likely resort to multiple

retransmissions, with the net effect that

wide bandwidth systems will transmit

continuously and totally occupy the

2400–2483 MHz band to the exclusion

of other devices. Silicon Wave supports

Intersil’s findings. Several parties state

that the Home RF proposal will cause

interference to devices under

development by Bluetooth, a crossindustry group formed to establish

industry-wide specifications for

unlicensed wireless voice and data

communications devices operating in

the 2.4 GHz band

4. WECA and other opponents of the

Home RF proposal offer several

proposals as a compromise to reduce the

potential for interference to other part

15 devices. They maintain that the

output power should be reduced much

further than the proposed 200

milliwatts. Several members of WECA

offer a compromise that would limit the

bandwidth of wide band frequency

hopping spread spectrum systems to 4

MHz, establish a minimum of 20

hopping channels, and restrict the

output power to 65 milliwatts. WECA

asserts that this proposal would be

consistent with European standard ETS

300 328. The ETS 300 328 standard

permits frequency hopping systems in

the 2.4 GHz band to use at least 20 nonoverlapping hopping channels, each

with up to 4 MHz bandwidth, and up to

100 mW effective radiated power, or 61

mW transmitter output power based on

an assumed antenna gain of 1.64. WECA

notes that, in a previous proceeding

where the Commission reduced the

number of required hops for spread

spectrum devices operating in the 915

MHz band, the output power was

reduced in proportion to the square in

the number of hopping frequencies. For

a system using a 4 MHz bandwidth the

number of hopping channels would be

reduced by a factor of approximately 4

(from 75 to 20 channels), and the output

power would need to be reduced by a

factor of 16 (from 1 watt to 60 mW).

WECA also suggests two additional

requirements. First, WECA proposes to

require interference rejection tests for

receivers in frequency hopping systems

having channel widths greater than 1

MHz. WECA states that the test is

necessary to ensure that receiver

performance is adequate to minimize

the need to retransmit packets, which,