Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61639

Authority: 21 U.S.C. 346a and 371.

2. Section 180.1189 is added to read

as follows:

§ 180.1189 Methyl salicylate; exemption

from the requirement of a tolerance.

The biochemical pesticide methyl

salicylate is exempt from the

requirement of a tolerance for residues

in or on food or feed when used as an

insect repellent in food packaging and

animal feed packaging at an application

rate that does not exceed 0.2 mg of

methyl salicylate per square inch of

packaging materials.

[FR Doc. 97–30251 Filed 11–18–97; 8:45am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300571; FRL–5752–8]

RIN 2070–AB78

Fomesafen; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

fomesafen in or on dry beans. This

action is in response to EPA’s granting

of emergency exemptions under section

18 of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

the pesticide on dry beans. This

regulation establishes a maximum

permissible level for residues of

fomesafen in this food commodity

pursuant to section 408(l)(6) of the

Federal Food, Drug, and Cosmetic Act,

as amended by the Food Quality

Protection Act of 1996. The tolerance

will expire and is revoked on October

31, 1998.

DATES: This regulation is effective

November 19, 1997. Objections and

requests for hearings must be received

by EPA on or before January 20, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300571],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300571], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300571]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Beard, Registration

Division (7505C), Office of Pesticide

Programs, Environmental Protection

Agency, 401 M St., SW., Washington,

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

Arlington, VA, (703) 308–9356, e-mail:

beard.andrea@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

U.S.C. 346a(e) and (l)(6), is establishing

a tolerance for residues of the herbicide

fomesafen, in or on dry beans at 0.05

part per million (ppm). This tolerance

will expire and is revoked on October

31, 1998. EPA will publish a document

in the Federal Register to remove the

revoked tolerance from the Code of

Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

and Cosmetic Act (FFDCA), 21 U.S.C.

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

(FIFRA), 7 U.S.C. 136 et seq. The FQPA

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996) (FRL–5572–9).

New 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

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 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

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

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.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.
61640 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations

II. Emergency Exemption for Fomesafen

on Dry Beans and FFDCA Tolerances

Requests were received from a

number of states for use of fomesafen on

dry beans for control of broadleaf

weeds. The Applicants state that since

the loss of the herbicides dinoseb and

chloramben, weed contamination in

U.S. bean fields has increased and

significant crop losses have occurred.

The Applicants state that available

alternative pesticides and control

techniques have produced unreliable

results, and that without this use of

fomesafen, significant economic losses

will occur. EPA has authorized under

FIFRA section 18 the use of fomesafen

on dry beans for control of broadleaf

weeds in Maine, Michigan, and New

York. After having reviewed the

submission, EPA concurs that

emergency conditions exist for these

states.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

fomesafen in or on dry beans. In doing

so, EPA considered the new 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 new 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 under

section 408(e), as provided in section

408(l)(6). Although this tolerance will

expire and is revoked on October 31,

1998, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on dry beans

after that date will not be unlawful,

provided the pesticide is applied in a

manner that was lawful under FIFRA.

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 fomesafen meets EPA’s

registration requirements for use on dry

beans 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 fomesafen 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 Maine, Michigan, and New

York to use this pesticide on this crop

under section 18 of FIFRA without

following all provisions of section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemption for fomesafen,

contact the Agency’s Registration

Division at the address provided above.

III. Risk Assessment and Statutory

Findings

EPA performs a number of analyses to

determine the risks from aggregate

exposure to pesticide residues. First,

EPA determines the toxicity of

pesticides based primarily on

toxicological studies using laboratory

animals. These studies address many

adverse health effects, including (but

not limited to) reproductive effects,

developmental toxicity, toxicity to the

nervous system, and carcinogenicity.

Second, EPA examines exposure to the

pesticide through the diet (e.g., food and

drinking water) and through exposures

that occur as a result of pesticide use in

residential settings.

A. Toxicity

1. Threshold and non-threshold

effects. For many animal studies, a dose

response relationship can be

determined, which provides a dose that

causes adverse effects (threshold effects)

and doses causing no observed effects

(the ‘‘no-observed effectlevel’’ or

‘‘NOEL’’).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

lowest NOEL by an uncertainty factor

(usually 100 or more) to determine the

Reference Dose (RfD). The RfD is a level

at or below which daily aggregate

exposure over a lifetime will not pose

appreciable risks to human health. An

uncertainty factor (sometimes called a

‘‘safety factor’’) of 100 is commonly

used since it is assumed that people

may be up to 10 times more sensitive to

pesticides than the test animals, and

that one person or subgroup of the

population (such as infants and

children) could be up to 10 times more

sensitive to a pesticide than another. In

addition, EPA assesses the potential

risks to infants and children based on

the weight of the evidence of the

toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100 percent

or less of the RfD) is generally

considered acceptable by EPA. EPA

generally uses the RfD to evaluate the

chronic risks posed by pesticide

exposure. For shorter term risks, EPA

calculates a margin of exposure (MOE)

by dividing the estimated human

exposure into the NOEL from the

appropriate animal study. Commonly,

EPA finds MOEs lower than 100 to be

unacceptable. This 100-fold MOE is

based on the same rationale as the 100-

fold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

‘‘acute,’’ ‘‘short-term,’’ ‘‘intermediate

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

to the pesticide for a period of 1-7 days,

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61641

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children. The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(Non-Nursing Infants <1 Year Old) was

not regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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 fomesafen and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

fomesafen on dry beans at 0.05 ppm.

EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by fomesafen are

discussed below.

1. Acute toxicity. EPA has selected the

developmental NOEL of 7.5 mg/kg/day

from the oral rat developmental toxicity

study for the acute dietary endpoint; at

the developmental LOEL of 50 mg/kg/

day, fetuses had delayed or partial

ossification and extra ribs. Since the

effect of concern is developmental, the

risk assessment will evaluate acute

dietary risk to the population subgroup

of concern, Females 13+ Years Old.

2. Short - and intermediate - term

toxicity. EPA has selected the NOEL of

10 mg/kg/day from the oral rabbit

developmental toxicity study for

calculation of short- and intermediateterm margins of exposure (MOEs). At

the LOEL of 40 mg/kg/day, maternal

toxicity included stomach mucosal

erosion and death.

3. Chronic toxicity. EPA has not

established the RfD for fomesafen. For

the purposes of this tolerance, based

upon available chronic toxicity data, the

RfD of 0.0025 mg/kg/day was used. This

RfD is based on the NOEL of 0.25 mg/

kg/day from the rat carcinogenicity

study. A 100-fold uncertainty factor was

used to calculate this RfD. At the LOEL

of 5.0 mg/kg/day there was liver toxicity

and decreased body weight.

4. Carcinogenicity. Fomesafen is

classified as a Group C carcinogen with

a Q* of 1.9 × 10-1 (mg/kg/day)-1. This

classification was based on: (i) Increases

in both adenomas and carcinomas at

several dose levels in both sexes of

mice; (ii) some evidence of reduced

latency for the time of tumor

appearance; (iii) limited evidence of

mutagenic effects; and, (iv) the

structural similarity of fomesafen to

other biphenyl ether herbicides which

have been shown to be carcinogenic.

B. Exposures and Risks

1. From food and feed uses. A

permanent tolerance has been

established (40 CFR 180.433) for the

residues of fomesafen, in or on soybeans

at 0.05 ppm. A time-limited tolerance

was also established on snap beans at

0.05 ppm recently, in connection with

use under several emergency

exemptions. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from fomesafen as

follows:

i. Acute exposure and risk. 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. The acute

dietary risk assessment used tolerance

level residue values and assumed 100

percent of crop treated. The resulting

high-end exposure estimate of 0.0002

mg/kg/day translates to a dietary MOE
61642 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations

of 37,500 for the population subgroup of

concern, Females 13+ Years Old. This

MOE is a conservative risk assessment;

refinement using anticipated residue

values and percent crop treated data in

conjunction with Monte Carlo analysis

would result in a lower acute dietary

exposure estimate.

ii. Chronic exposure and risk. For

assessing chronic exposure and risks,

anticipated residue values for all

commodities were used; and percent of

crop treated information for soybeans

only; it was assumed that 100 percent of

the snap bean crop in the eastern United

States (the region where exemptions

were issued, equivalent to 75 percent of

the domestic snap bean crop), and 100

percent of the dry bean crops were

treated. Based upon this, the existing

uses on soybeans, snap beans, and dry

beans result in an ARC that is

equivalent to the following percentages

of the RfD: U.S. population, 0.3%;

Nursing Infants, 0.3%; Non-nursing

Infants (<1 year old), 0.8%; Children (1-

6 years old), 0.7%; and Children (7-12

years old), 0.5%. Additional refinement

using percent of crop treated

information for all commodities would

result in lower dietary exposure

estimates.

iii. Cancer risk. A dietary (food only)

cancer risk assessment using anticipated

residues and percent crop treated

information, as described above, was

performed for the U.S. population. The

calculated food cancer risk from the

established tolerances (excludes this

action) is 8.5 × 10-7. This is an

overestimate, as not all of the snap bean

crop in the eastern United States will be

treated with fomesafen. The incremental

contribution to the dietary cancer risk

posed by this use on dry beans,

amortized over 5 years (the average

duration of a section 18 exemption,

including repeat uses), is 0.5 × 10-7.

Therefore, the total of the fomesafen

dietary cancer risk for the U.S.

population from all commodity

contributions, including this new

tolerance on dry beans, is 9.0 × 10-7. It

should be noted that this is an

overestimation of risk, because not all of

the snap bean crops in the eastern

United States, nor all of the dry bean

crops in the United States, will be

treated with fomesafen.

2. From drinking water. Fomesafen

was not included in EPA’s National

Survey of Pesticides in Drinking Water

Wells. There are no entries for

fomesafen in the Pesticides in Ground

Water Database. The Agency has not

established Maximum Contaminant

Levels or Health Advisory Levels for

residues of fomesafen in drinking water.

Based on available data, EPA

concludes that fomesafen could leach to

ground water and may reach levels of

1.0 microgram (μg)/Liter (L). The level

of 1.0 μg/L was based on a small scale

prospective groundwater monitoring

study conducted on soybeans at a

vulnerable site in North Carolina.

Fomesafen residues were detected in

ground water (in 4 of 9 wells) sampled

between 17 and 33 months after

application. Fomesafen concentrations

measured 1.0 μg/L (equal to the limit of

determination of the analytical method).

Exposures and risks from residues of

fomesafen in drinking water were

calculated, as follows:

Adult Exposure = (chemical

concentration in μg/L) × (10-3 mg/μg) ×

(2 L/day consumed) divided by (70 kg

body weight).

Child Exposure = (chemical

concentration in μg/L) × (10-3 mg/μg) ×

(1 L/day consumed) divided by (10 kg

body weight).

Adult exposure is thus calculated to

be 2.9 × 10-5 mg/kg/day and exposure of

children is calculated to be 1.0 × 10-4

mg/kg/day.

i. Acute exposure and risk. For the

population subgroup of concern for

acute exposure (Females 13+ Years

Old), the MOE is calculated at 260,000.

ii. Chronic exposure and risk.

Exposure to residues of fomesafen in

water utilizes 1.2% of the RfD for adults

and 4.0% of the RfD for children.

iii. Cancer risk. Based on exposure

levels for drinking water, as given

above, the estimate of cancer risk is 2.7

× 10-6. This figure is an overestimate, as

it was arrived at based on several very

conservative assumptions. Estimates

used were calculated based on data from

only one small scale study conducted in

NC, for use of fomesafen on soybeans at

a vulnerable site. This represents a

worst case scenario, so is not

representative of the ‘‘average’’

conditions of use. Additionally, there is

language on the product label warning

of the potential of fomesafen to leach to

ground water in vulnerable areas.

Vulnerable areas in this case refers to

areas where soils are permeable (sand

and silt loams) and the water table is

shallow. The majority of areas of

soybean production, and potential use

of fomesafen, will not likely be

vulnerable sites, thus the data used from

the one small scale study greatly

overestimates levels which could

actually occur. Further, it is assumed

that this exaggerated level will occur in

all drinking water throughout the US,

and that each individual consumes 2

liters of drinking water per day.

3. From non-dietary exposure.

Fomesafen is not currently registered for

use on sites that would be expected to

result in non-dietary (residential)

exposure. A non-dietary risk assessment

is thus not appropriate for existing uses

of fomesafen.

4. Cumulative exposure to substances

with 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.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61643

When considering structural

similarities with other chemicals,

fomesafen falls into the class of

‘‘biphenyl ether’’ chemical compounds;

this means that this group of chemicals

have structural similarities, including a

biphenyl ether group, in common. This

is used as a piece of supporting

evidence for the classification of

fomesafen as a Group C carcinogen,

since other chemicals of this group

(with similar structure) have been found

to be carcinogens. However, other

indications of the carcinogenicity of

fomesafen (i.e., increases of adenomas

and carcinomas in a mouse study,

limited evidence of mutagenic effects)

were also used in deciding this cancer

classification. At this time, the Agency

does not have sufficient understanding

of the structural relationship to the

mechanism of toxicity of these

chemicals to conclude that they may be

combined for the purposes of

conducting a risk assessment. Although

fomesafen contains some chemical

structures in common with other

chemicals that have been found to be

carcinogens, EPA does not yet fully

understand the implications of such a

relationship, nor how, or if, these

structures relate to the toxicological

activity of the chemical. For the

purposes of this tolerance action,

therefore, EPA has not assumed that

fomesafen has a common mechanism of

toxicity with other substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. For the population of

concern (Females 13+ Years Old), the

calculated aggregate MOE value is

23,000. The aggregate MOE is the

reciprocal of the sum of the reciprocal

of the MOEs for food (25,000) and water

(260,000). This aggregate MOE does not

exceed EPA’s level of concern for acute

dietary exposure.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to fomesafen from food will

utilize 1.5% (0.3% for food and 1.2%

for water) of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is Non-Nursing Infants,

discussed below. EPA generally has no

concern for exposures below 100% of

the RfD because the RfD represents the

level at or below which daily aggregate

dietary exposure over a lifetime will not

pose appreciable risks to human health.

Despite the potential for exposure to

fomesafen in drinking water, EPA does

not expect the aggregate exposure to

exceed 100% of the RfD. EPA concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to fomesafen residues.

D. Aggregate Cancer Risk for U.S.

Population

Using the conservative exposure

assumptions described above, the total

dietary (food only) cancer risk is

estimated at 9 × 10-7. This is an

overestimate, as not all of the snap and

dry bean crop in the eastern United

States will be treated with fomesafen.

For drinking water, the estimate of

cancer risk is 2.7 × 10-6. As stated above,

this figure was based on extremely

conservative assumptions, and thus is

an overestimate; taking this into

consideration, EPA scientists believe

that the actual aggregate cancer risk will

not exceed levels of concern.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children. i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

fomesafen, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database 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. EPA believes that reliable data

support using the standard 100-fold

safety factor (usually 100 for combined

inter- and intra-species variability) and

not the additional tenfold safety factor

when EPA has a complete data base

under existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard safety factor.

ii. Developmental toxicity studies. In

the rat developmental toxicity study, the

maternal (systemic) NOEL was

established at 100 mg/kg/day, based on

stained fur at the LOEL of 200 mg/kg/

day. The fetal (developmental) NOEL

was 7.5 mg/kg/day, based on extra ribs

and delayed ossification at the LOEL of

50 mg/kg/day.

In the rabbit developmental toxicity

study, the maternal (systemic) NOEL

was established at 10 mg/kg/day, based

on mortality and stomach lesions at the

LOEL of 40 mg/kg/day. The fetal

(developmental) NOEL was established

at 40 mg/kg/day (highest dose tested, no

effects seen).

iii. Reproductive toxicity study. In the

2-generation reproductive toxicity study

in rats, the parental (systemic) NOEL

was 12.5 mg/kg/day, based on decreased

body weight and liver necrosis at the

LOEL of 50 mg/kg/day. The

reproductive and developmental (pup)

NOELs were 2.5 mg/kg/day, based on

decreased pup body weight and reduced

litter size at the LOEL of 12.5 mg/kg/

day.

iv. Pre- and post-natal sensitivity.

There were no developmental effects in

rabbits at the highest dose tested, even

in the presence of maternal toxicity.

However, based on the developmental

toxicity study in rats, developmental

toxicity (alterations and delays in

skeletal ossification) occurred at a dose

level which was not maternally toxic,

suggesting a special sensitivity to the

fetus following in-utero exposure. Based

on the results of the rat developmental

toxicity study, an acute dietary risk

assessment was conducted for Females

13+ Years Old. The MOE of 23,000

obtained for this risk assessment

demonstrates that acute developmental

(pre-natal) risks are low.

v. Conclusion. Based on the rat

reproductive toxicity study discussed

above, the pup LOEL (decreased body

weight and reduced litter size) occurred

at levels below the maternal NOEL and

demonstrates post-natal pup toxicity

unrelated to maternal effects. These

results are suggestive of a special

sensitivity for infants and children

following post-natal exposure.

Therefore, EPA recommends applying

an extra 10-fold uncertainty (safety)

factor in the chronic risk analysis. The

low percentage of the RfD occupied by

the most highly exposed child subgroup

(4.8% of the RfD; 48% using the extra

10-fold factor) demonstrates that postnatal risks to infants and children are

low.

2. Acute risk. The acute, aggregate

dietary MOE of 33,000 which was

calculated for females 13+ years old,

accounts for both maternal and fetal
61644 Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations

exposure. The large aggregate MOE

calculated for females 13+ years old

provides assurance that there is a

reasonable certainty of no harm to

infants and children.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to fomesafen

from food and water utilizes from 4.3%

of the RfD for nursing infants up to

4.8% of the RfD for non-nursing infants.

As stated previously, the results from

the developmental rat study suggest a

special sensitivity to the fetus following

in-utero exposure; and results from the

reproductive rat study suggest a special

sensitivity for infants and children

following post-natal exposure.

Therefore, EPA recommends applying

an extra 10-fold uncertainty (safety)

factor, which would bring the exposures

given above to 43% and 48% of the RfD,

for nursing and non-nursing infants,

respectively. EPA generally has no

concern for exposures below 100% of

the RfD because the RfD represents the

level at or below which daily aggregate

dietary exposure over a lifetime will not

pose appreciable risks to human health.

The low percentage of the RfD occupied

by estimates for the most highly

exposed child population subgroup

demonstrates that risks to infants and

children are below EPA’s level of

concern, Use the following paragraph or

delete and insert applicable text. and

EPA concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to fomesafen residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residues in plants

and animals is adequately understood.

The residue of concern is fomesafen per

se. Secondary residues in meat, milk,

poultry, and eggs are not expected, since

dry beans are not considered a livestock

feed commodity.

B. Analytical Enforcement Methodology

An adequate enforcement method

(Method GAM-RM-001/86) is available

to enforce fomesafen tolerances.

C. Magnitude of Residues

Residues of fomesafen are not likely

to exceed 0.05 ppm in or on dry beans

as a result of this use. No animal feed

items are associated with this use, and

therefore, no secondary residues in

livestock commodities are expected to

result.

D. International Residue Limits

There are no CODEX or Canadian

maximum residue levels established for

residues of fomesafen in or on dry

beans. A Mexican tolerance of 0.01 ppm

is established for fomesafen residues in

or on ‘‘beans.’’

E. Rotational Crop Restrictions

The federally registered label for the

fomesafen product requested under

these exemptions carries the following

rotational crop restrictions: 4 months for

small grains; 10 months for corn, cotton,

peanuts, and rice; and 18 months for all

other crops, particularly sunflowers,

sugar beets, and sorghum. Part of the

use restrictions for these exemptions

includes that all applicable restrictions

on the federal label must be followed;

this includes these rotational crop

restrictions.

VI. Conclusion

Therefore, the tolerance is established

for residues of fomesafen in dry beans

at 0.05 ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

section 408(e) and (l)(6) as was provided

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by January 20, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is 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 in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (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.

VIII. Public Docket and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300571] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

inspection from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Highway, Arlington, VA.

Electronic comments may be sent

directly to EPA at: oppdocket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia
Federal Register / Vol. 62, No. 223 / Wednesday, November 19, 1997 / Rules and Regulations 61645

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a timelimited tolerance under FFDCA section

408(l)(6). 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). 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) (Pub. L.

104-4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), 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. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

Under 5 U.S.C. 801(a)(1)(A), as added

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted 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 General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This 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: October 22, 1997.

Peter Caulkins,

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. 346a and 371.

2. In § 180.433, by alphabetically

inserting the following item into the

table in paragraph (b) to read as follows:

§ 180.433 Sodium salt of fomesafen;

tolerance for residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/Revocation Date

* * * * * * *

Beans, dry ........................................................................................... 0.05 10/31/98

* * * * *

[FR Doc. 97–30383 Filed 11–18–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180 and 185

[OPP–300475A; FRL–5746–5]

RIN 2070–AC78

Hydroprene Biochemical Pest Control

Agent; Pesticide Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final Rule.

SUMMARY: This rule expands the

tolerance for residues of hydroprene,

[(S)-(Ethyl (2E,4E,7S)-3,7,11-trimethyl2,4-odecadienoate)], an insect growth

regulator, on all food items in foodhandling establishments to include

perimeters and pantries, and

warehouses to the list of permissible

food storage sites and ultra low volume

(ULV) fogging as a permissible treatment

method under certain precautions and

conditions. This rule also permits the

use of point source device treatments

providing those devices do not come

into direct contact with food

preparation surfaces and are kept a

minimum distance of 3 feet from

exposed foods. This rule also restricts

the tolerance expression to residues of

[(S)-(Ethyl(2E,4E,7S)-3,7,11-trimethyl

2,4-dodecadienoate)], the S-racemer of

hydroprene since the R-racemer is no

longer being supported in reregistration.

DATES: This regulation is effective

November 19, 1997. Objections and

requests for hearings must be received

by EPA on or before January 20, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300475A],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Rm. M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300475A], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may be submitted electronically by

sending electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Copies of