46888 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

this pesticide indicate that the tolerance

is not safe.

[FR Doc. 97–23628 Filed 9–4–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300535; FRL–5738–8]

RIN 2070–AB78

Triclopyr; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

triclopyr and its 3,5,6-trichloro-2-

pyridinol metabolite in or on fish at 0.2

ppm and shellfish at 5.0 ppm. 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

aquatic sites. This regulation establishes

a maximum permissible level for

residues of triclopyr in these

commodities pursuant to section

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

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996. These

tolerances will expire and are revoked

on December 31, 1998.

DATES: This regulation is effective

September 5, 1997. Objections and

requests for hearings must be received

by EPA on or before November 4, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300535],

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–

300535], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), 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–

300535]. 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: Olga Odiott, 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) 308-308-9363, e-mail:

odiott.olga@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 time-limited tolerances for residues of

the herbicide triclopyr and its

metabolite 3,5,6-trichloro-2-pyridinol,

in or on fish at 0.2 part per million

(ppm) and shellfish at 5.0 ppm. These

tolerances will expire and are revoked

on December 31, 1998. EPA will publish

a document in the Federal Register to

remove the revoked tolerances 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.

II. Emergency Exemption for Triclopyr

on Aquatic Sites and FFDCA

Tolerances

The Applicants stated that the Purple

loosestrife (Lythrum salicaria), an exotic

herbaceous perennial, if not controlled,

will have significant deleterious effects

on the States’ wetlands and wildlife.

The Purple loosestrife rapidly replaces

native vegetation and once established
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46889

is very difficult to control. As plant

diversity diminishes, wildlife species

are displaced from the wetlands due to

the loss of food sources and nesting

areas. The Purple loosestrife could

render the wildlife areas useless for the

intended purposes, and the millions of

dollars that have been invested by the

state and federal goverments would be

lost. Use of triclopyr will allow the

States to selectively remove the Purple

loosestrife without harming desirable

species. EPA has authorized under

FIFRA section 18 the use of triclopyr on

aquatic sites for control of the Purple

loosestrife in North Dakota and

Minnesota. After having reviewed their

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

triclopyr in or on fish and shellfish. In

doing so, EPA considered the new safety

standard in FFDCA section 408(b)(2),

and EPA decided that the necessary

tolerances 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 these tolerances without

notice and opportunity for public

comment under section 408(e), as

provided in section 408(l)(6). Although

these tolerances will expire and are

revoked on December 31, 1998, under

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

pesticide not in excess of the amounts

specified in the tolerances remaining in

or on fish and shellfish 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 these tolerances earlier

if any experience with, scientific data

on, or other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether triclopyr meets EPA’s

registration requirements for use on

aquatic sites or whether permanent

tolerances for this use would be

appropriate. Under these circumstances,

EPA does not believe that these

tolerances serve as a basis for

registration of triclopyr by a State for

special local needs under FIFRA section

24(c). Nor do these tolerances serve as

the basis for any State other than North

Dakota and Minnesota 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 triclopyr, 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 effect level’’ 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

study with 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% 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

residential exposure, are aggregated.

High-end exposures from all 3 sources
46890 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

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 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 triclopyr and to make a

determination on aggregate exposure,

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

time-limited tolerances for residues of

triclopyr and its metabolite 3,5,6-

trichloro-2-pyridinol in or on fish at 0.2

ppm and shellfish at 5.0 ppm. EPA’s

assessment of the dietary exposures and

risks associated with establishing these

tolerances follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by triclopyr are

discussed below.

1. Acute toxicity. The developmental

NOEL of 30 mg/kg/day from a rabbit

developmental study was recommended

for the acute dietary risk assessment. At

the lowest effect level (LEL) of 100 mg/

kg/day, there were decreased number of

live fetuses, increased fetal deaths,

reduced ossification of sternebrae and

digital bones, and increased percentage

of fetuses with 13 ribs. This risk

assessment will evaluate acute dietary

risk to pregnant females age 13 and

older.

2. Short - and intermediate - term

toxicity. Based on the available data, the

Agency has determined that short- and

intermediate-term dermal and

inhalation risk assessments are not

required. A systemic NOEL of 1,000 mg/

kg/day, the highest dose tested, (HDT)

was determined in a 21-day dermal

toxicity study in rabbits. The LC50 from

the acute inhalation study was

determined to be ≤ 2.6 mg/L (Toxicity

Category IV).

3. Chronic toxicity. EPA has

established the RfD for triclopyr at 0.05

milligrams/kilogram/day (mg/kg/day).

This RfD is based on a reproductive

toxicity study in rats with a NOEL of 5

mg/kg/day using an Uncertainty Factor

of 100. At the next higher dose level

(HDL) of 25 mg/kg/day, an increased

incidence of degeneration of the

proximal tubules of the kidney was

observed in P1 and P2 parents of both

sexes. On this basis, the RfD was

calculated to be 0.05 mg/kg/day.

4. Carcinogenicity. The Agency’s

Cancer Peer Review Committee (CPRC)

concluded that triclopyr should be

classified as ‘‘Group D chemical’’ - not

classifiable as to human carcinogenicity.

A cancer risk assessment is not

required.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.417) for the residues of

triclopyr in or on a variety of raw

agricultural commodities. and its

metabolites 3,5,6-trichloro-2-pyridinol

and 2-methoxy-3,5,6-trichloropyridine,

expressed as triclopyr, in or on rice

grain (0.3 ppm), rice straw (10.0 ppm),

grass forage (500 ppm), and grass hay

(500 ppm). Tolerances for triclopyr and

the two metabolites have been

established for poultry meat, fat, and

meat byproducts (except kidney) at 0.1

ppm and eggs at 0.05 ppm. Tolerances

for triclopyr and the metabolite 3,5,6-

trichloro-2-pyridinol have been

established for meat, fat, and meat

byproducts (except liver and kidney) of

cattle, goats, hogs, horses, and sheep at

0.05 ppm; liver and kidney of cattle,

goats, hogs, horses, and sheep at 0.5

ppm; and milk at 0.01 ppm. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

triclopyr as follows:
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46891

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 (food only) risk assessment

assumed tolerance level residues and

100% crop treated values. For pregnant

females age 13 years and older, the

dietary (food only) MOE was estimated

as 2500. This estimate should be viewed

as a conservative risk estimate.

Refinement of the risk assessment using

anticipated residue values and percent

crop-treated data would result in a

lower acute dietary exposure estimate.

ii. Chronic exposure and risk. The

chronic dietary risk assessment assumed

that 100% of fish and shellfish and all

other commodities having triclopyr

tolerances will contain triclopyr

residues and those residues would be at

the level of the tolerance, which result

in an overestimate of human dietary

exposure. Thus, in making a safety

determination for these tolerances, EPA

is taking into account this conservative

exposure assessment. The existing

triclopyr tolerances (published,

pending, and including the necessary

Section 18 tolerances) result in a TMRC

that is equivalent to percentages of the

RfD that range from 0. 9% for nursing

infants < 1 year old, to 2.6% for nonnursing infants < 1 year old.

2. From drinking water. Based on

available data used in EPA’s assessment

of environmental risk, triclopyr is not

persistent in water. The degradation

product 3,5,6-trichloro-2-pyridinol

(TCP) is mobile. There are no

established Maximum Contaminant

Levels for residues of triclopyr in

drinking water. No health advisory

levels for triclopyr in drinking water

have been established. Triclopyr has

been detected in 5 wells out of 379

wells tested in four states. The

concentrations ranged from 0.006 to

0.58 ppb. For surface water, at the

maximum application rate of 12.12 lbs.

a.i./A, the maximum concentration was

364 ppb and the 56-day concentration

was 233 ppb.

The drinking water risk assessment

was based on surface water exposure,

which is considered to represent the

worst case scenario in comparison to

ground water. The maximum

concentration of triclopyr residues (364

ppb) was used to calculate the acute

exposures for adult females and

children. The 56-day concentration (233

ppb) was used to calculate the chronic

exposures for adult females and

children. It was assumed that adult

females consume 2 liters of water a day

and children consume 1 liter of water a

day.

i. Acute exposure and risk. The

exposure for adult females was

estimated as 1.2 x 10-2 mg/kg/day. The

exposure for children was estimated as

3.6 x 10-2 mg/kg/day. The corresponding

MOE values were 2500 for pregnant

females and 825 for children. These

values do not exceed the Agency’s level

of concern.

ii. Chronic exposure and risk. The

chronic exposure was estimated as 7.7

x 10-3 mg/kg/day for adult females and

2.3 x 10-2 mg/kg/day for children. These

chronic exposures to triclopyr from

drinking water will utilize 15% of the

RfD for adult females and 46% of the

RfD for children. The Agency concludes

that that there is a reasonable certainty

that no harm will result from drinking

water exposures to triclopyr.

3. From non-dietary exposure.

Triclopyr is currently registered for use

on outdoor non-food sites such as turf

and ornamentals. These uses may result

in non-occupational exposures.

However, the available data indicate no

evidence of significant toxicity and a

reasonable certainty that no harm will

result from non-occupational exposures

to triclopyr residues.

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).

EPA does not have, at this time,

available data to determine whether

triclopyr 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,

triclopyr 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 triclopyr 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

subgroup of concern, pregnant females

age 13 and older, the Agency estimated

an MOE of 1250 for the acute aggregate

dietary risk (food + water) from

exposures to triclopyr residues.

Residential exposure was considered to

be negligible. Therefore, the aggregate

exposure is not expected to exceed the

Agency’s level of concern.

2. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that the percentage

of the RfD that will be utilized by

aggregate exposures [food + water] to

residues of triclopyr ranges from 16%

[1% for food and 15% for water] to 48%

[46% for water and 2% for food] for the

U.S. population. The major identifiable

subgroup with the highest aggregate

exposure is non-nursing infants <1 year

old (discussed below). There are no

chronic exposure scenarios for nondietary uses of triclopyr which would
46892 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

contribute to the aggregate risk. 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. EPA concludes that

there is a reasonable certainty that no

harm will result from aggregate

exposure to triclopyr residues.

3. Short- and intermediate-term risk.

Short- and intermediate-term aggregate

exposure takes into account chronic

dietary food and water (considered to be

a background exposure level) plus

indoor and outdoor residential

exposure. Although there is potential for

outdoor residential exposures, the

Agency has determined that short- and

intermediate-term risk assessments are

not required. The available data indicate

no evidence of significant toxicity and

a reasonable certainty that no harm will

result from these exposures to triclopyr

residues.

D. Aggregate Cancer Risk for U.S.

Population

The Agency’s CPRC concluded that

triclopyr should be classified as ‘‘Group

D chemical’’ - not classifiable as to

human carcinogenicity.

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

triclopyr, EPA considered data from

developmental toxicity studies in the rat

and rabbit and a two-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— a.

Rats: The maternal (systemic) NOEL

was 100 mg/kg/day, based on increased

salivation and mortality at the lowest

observed effect level (LOEL) of 300 mg/

kg/day. The developmental (fetal) NOEL

was 100 mg/kg/day, based on skeletal

anomalies at the LOEL of 300 mg/kg/

day.

b. Rabbits. The maternal (systemic)

NOEL was 30 mg/kg/day, based on

increased mortality and cesearean

section observations at the LOEL of 100

mg/kg/day. The developmental (fetal)

NOEL was 30 mg/kg/day, based on

skeletal anomalies and variants at the

LOEL of 100 mg/kg/day.

iii. Reproductive toxicity study—

Rats. In the 2-generation reproductive

toxicity study in rats, the parental

(systemic) NOEL was 2.5 mg/kg/day,

based on an increased incidence of

degeneration of the proximal tubules of

the kidney, observed in P1 and P2

parents of both sexes at the LOEL of 25

mg/kg/day. The developmental (pup)

NOEL was 25 mg/kg/day based on

decreased litter size, decreased body

weight, and decreased survival at the

LOEL of 250 mg/kg/day.

iv. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal toxicity for triclopyr

is complete with respect to current data

requirements. There are no pre- or postnatal toxicity concerns for infants and

children, based on the results of the rat

and rabbit developmental toxicity

studies and the 2-generation rat

reproductive toxicity study. The

developmental studies in rats and

rabbits both have the maternal NOELs

and LOELs at the same doses as the

developmental NOELs and LOELs,

respectively, and demonstrate that no

pre-natal extra sensitivity is present.

However, based on the developmental

effects observed in rabbits, an acute

dietary risk assessment was performed

for women age 13 and older. The MOE

was estimated as 2500.

The 2-generation rat reproduction

study did not demonstrate any pre- or

post natal extra sensivity for infants and

children, since the developmental/

reproductive (pup) findings occurred at

250 mg/kg/day in the presence of severe

maternal toxicity.

v. Conclusion. The EPA concludes

that reliable data support use of the

standard 100-fold margin of exposure/

uncertainty factor and that an additional

margin/factor is not needed to protect

infants and children.

2. Acute risk. The acute aggregate

dietary MOE (food + water) was

calculated to be 1250 for females age 13

and older (accounts for both maternal

and fetal exposure), the population

subgroup of concern. The MOE

calculations were based on the

developmental NOEL in rabbits of 30

mg/kg/day. This risk assessment

assumed 100% crop-treated with

tolerance level residues on all treated

crops consumed, resulting in a

significant over-estimate of dietary

exposure. The large acute dietary MOE

calculated for females age 13 and older

provides assurance that there is a

reasonable certainty of no harm for

infants and children from exposures to

triclopyr.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that the chronic aggregate (food + water)

exposure to triclopyr for infants and

children occupies 48% of the RfD. 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. There are no chronic

exposure scenarios for non-dietary uses

of triclopyr which would contribute to

the aggregate risk. Taking into account

the completeness and reliability of the

toxicity data and this conservative

exposure assessment, EPA concludes

that there is a reasonable certainty that

no harm will result to infants and

children from aggregate exposure to

triclopyr residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in fish and

shellfish is adequately understood. The

residues of concern in fish and shellfish

are the parent triclopyr and its

metabolite 3,5,6-trichloro-2-pyridinol.

The residues specified in 40 CFR

180.417 for fish and shellfish are the

parent compound triclopyr and its two

metabolites 3,5,6-trichloro-2-pyridinol

and 2-methoxy-3,5,6-trichloropyridine.

However, the Agency’s Metabolism

Committee determined that the residue

to be regulated in plants, milk, poultry,

and eggs is parent triclopyr only. The

residues to be regulated in meat and

meat byproducts are triclopyr and 3,5,6-

trichloro-2-pyridinol .
Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations 46893

B. Analytical Enforcement Methodology

Adequate enforcement methodologies

(gas chromatography with ECD) are

available in PAM, Vol. II, Methods I and

II for plant and animal commodities to

enforce the tolerance expression.

C. Magnitude of Residues

Residues of triclopyr and its regulated

metabolites are not expected to exceed

0.2 ppm in fish and 5.0 ppm in shellfish

as a result of this Section 18 use.

Provided irrigation with treated water is

restricted for two weeks (product label

restriction), measurable residues in

irrigated crops are unlikely. Secondary

residues in animal commodities are not

expected to exceed existing tolerances

as a result of this Section 18 use.

D. International Residue Limits

There are no Codex proposals (step 6

or above), Canadian limits, or Mexican

limits for triclopyr on fish and shellfish.

E. Rotational Crop Restrictions.

Residues in rotational crops are not a

concern for this use of triclopyr on

aquatic sites since crops will not be

rotated into the treated aquatic sites.

VI. Conclusion

Therefore, time-limited tolerances are

established for residues of triclopyr and

its metabolite 3,5,6-trichloro-2-pyridinol

in /on fish at 0.2 ppm and shellfish at

5.0 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 November 4,

1997, 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 Record

EPA has established a record for this

rulemaking under docket control

number [OPP–300535] (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 (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@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

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes timelimited tolerances 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

tolerances 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

acations published on May 4, 1981 (46

FR 24950), and was provided to the
46894 Federal Register / Vol. 62, No. 172 / Friday, September 5, 1997 / Rules and Regulations

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: August 22, 1997.

James Jones,

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. Section 180.417 is amended as

follows:

a. By adding a heading to paragraph

(a) and redesignating the text of

paragraph (a) as paragraph (a)(1).

b. By redesignating paragraph (b) as

paragraph (a)(2).

c. By adding a new paragraph (b).

d. By adding headings and reserving

paragraphs (c) and (d).

Section 180.417, as amended, reads as

follows:

§ 180.417 Triclopyr; tolerances for residues.

(a) General. * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the combined residues of the

herbicide triclopyr ((3,5,6-trichloro-2-

pyridinyl)oxy)acetic acid and its

metabolite 3,5,6-trichloro-2-pyridinol in

connection with use of the pesticide

under section 18 emergency exemptions

granted by EPA. The tolerance is

specified in the following table. The

tolerances will expire and are revoked

on the dates specified in the following

table:

Commodity Parts per

million

Expiration/

revocation

date

Fish ................... 0.2 12/31/98

Shellfish ............. 5.0 12/31/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–23683 Filed 9–4–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300543; FRL–5740–6]

RIN 2070–AB78

Bifenthrin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

bifenthrin in or on canola seed. 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 in Idaho, Oregon, and

Washington. This regulation establishes

a maximum permissible level for

residues of bifenthrin 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 September

30, 1998.

DATES: This regulation is effective

September 5, 1997. Objections and

requests for hearings must be received

by EPA on or before November 4, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300543],

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–

300543], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), 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–

300543]. 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

insecticide bifenthrin, in or on canola

seed at 0.5 part per million (ppm). This

tolerance will expire and is revoked on

September 30, 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