Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations 47561

§ 180.493 [Corrected]

1. On page 39961, amendatory

instruction 2 is corrected to read as

follows:

‘‘2. Section 180.493 is amended in

paragraph (b) by revising the

introductory text and alphabetically

adding the following tolerances to the

table to read as follows:.’’

2. Correct the table by adding in

paragraph (b) five stars at the beginning

of the table.

[FR Doc. 97–23974 Filed 9-9-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185 and 186

[OPP–300549; FRL–5743–6]

RIN 2070–AB78

Triadimefon; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

triadimefon in or on asparagus and in or

on artichokes. 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 asparagus and artichokes.

This regulation establishes maximum

permissible levels for residues of

triadimefon in these food 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

September 1, 1999.

DATES: This regulation is effective

September 10, 1997. Objections and

requests for hearings must be received

by EPA on or before November 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300549],

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–

300549], 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–

300549]. 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) 308–9363, 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

tolerances for residues of the fungicide

triadimefon, in or on asparagus at 0.15

part per million (ppm), and in or on

artichokes at 0.6 ppm. These tolerances

will expire and are revoked on

September 1, 1999. 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.
47562 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations

II. Emergency Exemption for

Triadimefon on Asparagus and

Artichokes and FFDCA Tolerances

The state of Michigan availed itself of

the authority to declare a crisis

exemption to use triadimefon to control

the asparagus rust (Puccinia asparagi).

EBDC fungicides are available and are

effective against the asparagus rust but

processors in Michigan will not accept

asparagus treated with EBDCs, leaving

the Michigan growers with no

alternative for control of the disease.

Yield declines of 20 to 50% are possible

without the use of triadimefon.

The state of California stated that

powdery mildew, caused by the fungus

Leveillula taurica Lev., is a relatively

new disease of artichokes that was first

detected by growers in California during

the summer of 1985. It is now endemic

in most artichoke growing districts,

affecting more than 65% of the

artichoke acreage. Currently, there are

no registered fungicides or alternative

practices available that will control

powdery mildew on artichokes. If

triadimefon is not available for use,

yield losses of 30 to 50% are expected.

EPA has authorized under FIFRA

section 18 the use of triadimefon on

asparagus and artichokes for control of

rust in Michigan and powdery mildew

in California. After having reviewed

their submissions, 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

triadimefon in or on asparagus and in or

on artichokes. 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 September 1,

1999, under FFDCA section 408(l)(5),

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on asparagus

and in or on artichokes 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 triadimefon meets EPA’s

registration requirements for use on

asparagus and artichokes or whether

permanent tolerances for these uses

would be appropriate. Under these

circumstances, EPA does not believe

that these tolerances serves as a basis for

registration of triadimefon 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

Michigan and California to use this

pesticide on these crops 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 triadimefon, 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 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.
Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations 47563

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

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 triadimefon and to make a

determination on aggregate exposure,

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

time-limited tolerances for residues of

triadimefon in or on asparagus at 0.15

ppm and in or on artichokes at 0.6 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 triadimefon are

discussed below. Triadimenol is a

metabolite of triadimefon and is also an

active ingredient in pesticide products

(ex. Baytan). Toxicological endpoints for

triadimefon and triadimenol are

presented below.

1. Acute toxicity. The NOEL of 20 mg/

kg/day from a rabbit developmental

study was selected for assessing acute

dietary risk from residues of

triadimefon. The risk assessment will

evaluate acute dietary risks for females

13+ years old.

The Agency has determined that an

acute dietary risk assessment is not

required for triadimenol. This decision

was based on the lack of developmental

effects at a maternally toxic dose of

triadimenol in a rabbit developmental

study.

2. Short - and intermediate - term

toxicity. The Agency determined that

the NOEL of 20 mg/kg/day from the

developmental toxicity study in rabbits

should be used to assess risks from short

and intermediate-term exposures to

residues of triadimefon.

The Agency determined that the

NOEL of 250 mg/kg/day (highest dose

tested) from a 21–day dermal toxicity

study in rabbits should be used to assess

risks from short- and intermediate-term

exposures to residues of triadimenol.

3. Chronic toxicity. EPA has

established the RfD for triadimefon at

0.04 milligrams/kilogram/day (mg/kg/

day). This RfD is based on a 2–year dog

feeding study. The NOEL for systemic

toxicity in dogs of either sex was 11.4

mg/kg/day and the LOEL was 33.7 mg/

kg/day based on decreased food intake,

depression in weight gain, and

significantly (p < 0.05) increased

alkaline phosphatase activity in both

sexes. An uncertainty factor (UF) of 300

was applied to account for inter-species

extrapolation (10), intra-species

variability (10) and the lack of an

adequate reproductive toxicity study in

rats (3).

The RfD for triadimenol was

established at 0.038 mg/kg/day. This

RfD is based on 2–year and 6–month
47564 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations

feeding studies in dogs with a NOEL of

3.75 mg/kg/day and an uncertainty

factor of 100 based on changes in

enzyme levels at the LOEL of 15.0 mg/

kg/day.

4. Carcinogenicity. The Agency’s

Carcinogenicity Peer Review Committee

(CPRC) has classified triadimefon as a

Group C (possible human carcinogen)

chemical without a Q1* and

recommended using the RfD approach

to assess dietary cancer risk. The

classification was based on an increase

in thyroid adenomas in male rats and an

increase in hepatocellular adenomas,

with a positive dose-related trend, in

both male and female mice.

The CPRC classified triadimenol as a

Group C (possible human carcinogen)

chemical based on liver tumors in

female mice. The Committee

recommended using the RfD approach

to assess dietary cancer risk.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.410) for the combined residues

of triadimefon and its metabolites

containing chlorophenoxy and triazole

moieties (expressed as triadimefon), in

or on a variety of raw agricultural

commodities ranging from 0.04 ppm in

poultry meat to 145 ppm in grass seed

cleanings.

Tolerances have been established (40

CFR 180.450(a)) for the combined

residues of the fungicide triadimenol

(KWG-0519,β-(4-chlorophenoxy)-α-(1,1-

dimethylethyl)-1H-1,2,4-triazol-1-

ethanol) and its butanediol metabolite

(KWG-1342; 4-(4-chlorophenoxy)-2,2-

dimethyl-4-(1H-1,2,4-triazol-1-yl)-1,3-

butanediol), calculated as triadimenol,

in or on various commodities including

barley, oats and wheat grain at 0.05

ppm; barley, oats and wheat forage at

2.5 ppm; and barley, oats and wheat

straw at 0.1 ppm. Tolerances have been

established (40 CFR 180.450(b)) for the

combined residues of triadimenol and

its metabolites containing the

chlorophenoxy moiety (calculated as

triadimenol) in or on the fat, meat, and

meat by-products of cattle, goats, hogs,

horses and sheep at 0.1 ppm; milk at

0.01 ppm; the fat, meat, and meat byproducts of poultry at 0.01 ppm; and

eggs at 0.01 ppm. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from triadimefon

and triadimenol 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 1–day or single exposure. The acute

dietary (food only) risk assessment for

triadimefon used tolerance level

residues and assumed 100% crop

treated. For the population subgroup of

concern, females 13+ years old, the

resulting high-end exposure estimate of

0.05 mg/kg/day results in a dietary (food

only) MOE of 400. This MOE 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.

Acute dietary endpoints were not

identified for triadimenol, so this risk

assessment was not conducted.

ii. Chronic exposure and risk. The

chronic dietary risk assessment for

triadimefon assumed that 100% of

asparagus and artichokes and all other

commodities having established and

pending triadimefon tolerances will

contain triadimefon residues and those

residues will be at tolerance level,

which result in an overestimate of

human dietary exposure. The existing

triadimefon 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 18% for the U.S.

population to 75% for non-nursing

infants < 1 year old.

The chronic dietary risk assessment

for triadimenol assumed that all

commodities having established and

pending triadimenol tolerances will

contain triadimenol residues and those

residues will be at the level of the

tolerance, which result in an

overestimate of human dietary

exposure. Thus, in making a safety

determination for triadimenol, EPA is

taking into account this conservative

exposure assessment. The existing

triadimenol tolerances (published and

pending) result in a TMRC that is

equivalent to percentages of the RfD that

range from 1% for the U.S. population

to 3% for non-nursing infants < 1 year

old.

2. From drinking water. Based on

available data used in EPA’s assessment

of environmental risk, triadimefon and

triadimenol are mobile and have the

potential to leach into ground water.

There are no established Maximum

Contaminant Levels for residues of

triadimefon or triadimenol in drinking

water, and no Health Advisory levels for

triadimefon or triadimenol in drinking

water have been established. According

to the ‘‘Pesticides in Groundwater

Database’’, EPA 734–12–92–001, Sept

1992, 14 wells in California were

sampled for triadimefon from 1984–

1989. No wells had detectable residues.

There was no entry for triadimenol.

Because the Agency lacks sufficient

water-related exposure data to complete

a comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause triadimefon and

triadimenol to exceed the RfD if the

tolerances being considered in this

document were granted. The Agency

has therefore concluded that the

potential exposures associated with

triadimefon and triadimenol in water,

even at the higher levels the Agency is

considering as a conservative upper

bound, would not prevent the Agency

from determining that there is a

reasonable certainty of no harm if the

tolerances are granted.

3. From non-dietary exposure.

Triadimefon is currently registered for

use on non-food sites such as

ornamentals and turfgrass. Triadimenol

is currently registered for use on

turfgrass. Based on the nature of the

outdoor residential uses, the EPA

concludes that chronic residential

exposure scenarios do not exist for

triadimefon. Short and/or intermediate

term exposure scenarios may exist.

However, the Agency currently lacks

sufficient residential-related exposure

data to complete a comprehensive

residential risk assessment for many

pesticides, including triadimefon.

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
Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations 47565

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).

Triadimefon and triadimenol are

members of the triazole class of

pesticides. Other members of this class

include tebuconazole, propiconazole,

cyproconazole, penconazole,

myclobutanil, and difenoconazole. At

this time, the Agency has not made a

determination that triadimefon and

other substances that may have a

common mode of toxicity would have

cumulative effects, with the exception

of triadimenol. A regulated metabolite

of triadimefon, triadimenol is itself a

fungicide active ingredient registered for

use on several crops. In plants, the

residue of concern for triadimenol is

triadimenol and its butanediol

metabolite. In animal commodities, the

residue of concern for triadimenol is

triadimenol and its metabolites

containing the chlorophenoxy moiety.

To estimate the cumulative

(triadimefon + triadimenol) aggregate

dietary exposures, estimates for

triadimenol on its regulated

commodities were added to estimates

for triadimefon.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. For the population

subgroup of concern, females 13+ years,

the calculated MOE value for

triadimefon dietary (food) exposure is

400. Although there is potential for

exposure to triadimefon in drinking

water, the Agency does not expect the

aggregate exposure (food plus water) to

exceed the Agency’s level of concern.

No acute toxicity endpoints were

identified for triadimenol, therefore an

acute aggregate risk assessment was not

conducted.

2. Chronic risk. Using the TMRC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to triadimefon and triadimenol

from food will utilize 19% of the RfD for

the U.S. population. The major

identifiable subgroup with the highest

aggregate exposure is non-nursing

infants < 1 year old. 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 triadimefon and

triadimenol in drinking water and from

non-dietary, non-occupational exposure,

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 triadimefon and

triadimenol 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.

Based on the registered uses of

fenarimol short and/or intermediate

term exposure scenarios may exist.

However, the Agency currently lacks

sufficient residential-related exposure

data to complete a comprehensive

residential risk assessment for many

pesticides, including triadimefon.

D. Aggregate Cancer Risk for U.S.

Population

The Agency’s CPRC recommended the

RfD approach for assessment of dietary

cancer risk. Dietary risk concerns due to

long-term exposures to triadimefon and

triadimenol residues are adequately

addressed by the aggregate chronic

dietary risk assessment.

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

triadimefon and triadimenol, 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 (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. For triadimefon, the maternal

systemic NOEL was 30 mg/kg/day and

the LOEL was 90 mg/kg/day. Effects

seen at the LOEL include statistically

significant body weight gain decrement

during gestational days 6–15. The

developmental NOEL was 30 mg/kg/day

and the developmental LOEL was 90

mg/kg/day, based on the increased

incidence of skeletal variations,

unossified and incompletely ossified

hyoid, and full and rudimentary ribs.

For triadimenol, the maternal

(systemic) NOEL was 25 mg/kg/day,

based on decreased body weight and

food consumption at the LOEL of 125

mg/kg/day. The developmental (fetal)

NOEL was 125 mg/kg/day (highest dose

tested (HDT)).
47566 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations

b. Rabbits. For triadimefon, the

maternal (systemic) NOEL was 50 mg/

kg/day and the LOEL was 120 mg/kg/

day. The maternal LOEL was based on

increased clinical signs such as

increased hyperactivity, reddish

discharge, and decreased body weight

gain during gestational days 6–10. The

developmental NOEL was 20 mg/kg/day

and the LOEL was 50 mg/kg/day, based

on irregular spinous process and

incomplete ossification of various

bones.

For triadimenol, the maternal

(systemic) NOEL was 8 mg/kg/day,

based on decreased body weight and

food consumption at the LOEL of 40

mg/kg/day. The developmental (fetal)

NOEL was 40 mg/kg/day, based on postimplantation loss, decreased fetal body

weight, and skeletal anomalies at the

LOEL of 200 mg/kg/day.

iii. Reproductive toxicity study. An

acceptable reproductive toxicity study is

not available for triadimefon.

For triadimenol, the maternal

(systemic) NOEL from a 2-generation

reproductive toxicity study in rats was

5.0 mg/kg/day. The NOEL was based on

decreased body weight at the LOEL of

25 mg/kg/day. The developmental (pup)

NOEL was 5.0 mg/kg/day, based on

decreased body weight at the LOEL of

25 mg/kg/day. The reproductive NOEL

was 25 mg/kg/day (HDT).

iv. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal toxicity for

triadimefon is not complete with respect

to current data requirements. However,

in calculating the RfD, an uncertainty

factor (UF) of 300 was applied to

account for inter-species extrapolation

(10), intra-species variability (10), and

the lack of an adequate reproductive

toxicity study in rats (3). The Agency

notes that there is approximately a twofold difference between the

developmental NOEL of 20 mg/kg/day

from the rabbit developmental toxicity

study and the NOEL of 11.4 mg/kg/day

from the 2-year dog feeding study which

was the basis of the RfD. It is further

noted that in the rabbit developmental

toxicity study, the developmental NOEL

of 20 mg/kg/day (on which the MOE

calculations for acute dietary risks are

based) is lower than the maternal

systemic NOEL of 50 mg/kg/day from

the same rabbit developmental study.

The Agency believes that the additional

3X uncertainty factor, together with the

very conservative assumptions made for

the exposure assessment, provide

adequate protection to infants and

children from the risks associated with

exposures to triadimefon residues.

The toxicological data base for

evaluating pre- and post-natal toxicity

for triadimenol is complete with respect

to current data requirements. There are

no pre- or post-natal 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 rat developmental study had

no developmental effects up to the

highest dose tested, which produced

maternal toxicity. The rabbit

developmental toxicity study

demonstrated maternal toxicity at a dose

at which no developmental toxicity was

apparent. In the rat reproductive

toxicity study, the parental and pup

effects occur at the NOELs and LOELs

and the same effect (decreased body

weight) occurred in both pups and

parental animals.

v. Conclusion. Based on the above

considerations and in EPA’s best

scientific judgment, the application of a

margin of exposure/uncertainty factor of

300 provides adequate protection for

infants and children from the risks

associated with exposures to

triadimefon residues.

The EPA also concludes that, for

triadimenol, 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. For triadimefon, the

acute dietary (food only) MOE was

calculated to be 400 for females 13+

years old (accounts for both maternal

and fetal exposure), the population

subgroup of concern. This risk

assessment for triadimefon used

tolerance level residues and assumed

100% crop treated. This MOE should be

viewed as a conservative risk estimate;

further refinement using anticipated

residue values and percent crop-treated

data would result in a lower acute

dietary exposure estimate. The large

acute dietary MOE calculated for

females 13+ years provides assurance

that there is a reasonable certainty of no

harm for both females 13+ years and the

pre-natal development of infants.

Despite the potential for exposure to

triadimefon in drinking water, the

Agency does not expect the aggregate

exposure (food + water) to exceed the

Agency’s level of concern for acute

dietary exposure.

No acute toxicity endpoints were

identified for triadimenol, so an acute

aggregate risk assesment was not

conducted.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to triadimefon

and triadimenol from food will utilize

percentages of the RfD that range from

28% for children 7–12 years old, up to

78% for non-nursing infants less than 1

year old. 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

triadimefon and triadimenol in drinking

water and from non-dietary, nonoccupational exposure, 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 to infants and children

from aggregate exposure to triadimefon

and triadimenol residues.

4. Short- or intermediate-term risk.

Based on the registered uses of

fenarimol short and/or intermediate

term exposure scenarios may exist.

However, the Agency currently lacks

sufficient residential-related exposure

data to complete a comprehensive

residential risk assessment for many

pesticides.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of triadimefon residues in

plants is adequately understood. The

Agency’s Metabolism Committee

determined that the residues of concern

are triadimefon and its metabolites

containing chlorophenoxy and triazole

moieties, expressed as triadimefon. The

nature of triadimefon residues in

animals is not germane to these

tolerances as no livestock feed items are

involved.

B. Analytical Enforcement Methodology

Adequate enforcement methods (GC/

MS) are published in the Pesticide

Analytical Manual, Volume II, Pesticide

Reg. Sec. 180.410, as Methods I and II.

In addition, Mobay Method No. 80488

has undergone a successful method trial

and has been validated for

determination of triadimefon and its

metabolites relevant to 40 CFR 180.410

on plant commodities.

C. Magnitude of Residues

Regulable residues of triadimefon are

not expected to exceed 0.15 ppm in/on

asparagus and 0.6 ppm in/on globe

artichokes as a result of these section 18

uses. Secondary residues are not

expected in animal commodities as no

feed items are associated with these

section 18 uses.

D. International Residue Limits

There are no CODEX, Canadian, or

Mexican maximum residue limits

(MRLs) established for residues of
Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations 47567

triadimefon in/on asparagus or in/on

artichokes.

VI. Conclusion

Therefore, time-limited tolerances are

established for the regulable residues of

triadimefon in asparagus at 0.15 ppm

and in artichokes at 0.6 ppm. In

addition, because the FQPA eliminated

the distinctions between processed

food, feed and raw agricultural

commodities, OPP is transferring the

tolerances for residues of triadimefon in

§§ 185.800 and 186.800 to the table in

paragraph (a) of § 180.410 and removing

the remainder of §§ 185.800 and

186.800.

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 10,

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 Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300549] (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 Highway, 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(d 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

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).
47568 Federal Register / Vol. 62, No. 175 / Wednesday, September 10, 1997 / Rules and Regulations

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 185

Environmental protection, Food

additives, Pesticides and pests.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.

Dated: August 29, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. By amending § 180.410 as follows:

i. By revising the section heading.

ii. By adding a subject heading to

paragraph (a).

iii. By revising paragraphs (b) and (c).

iv. By adding and reserving paragraph

(d) with a subject heading.

§ 180.410 Triadimefon; tolerances for

residues.

(a) General . * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for the combined residues of the

fungicide triadimefon, 1-(4-

chlorophenoxy)-3,3-dimethyl-1(1H1,2,4-triazol-1-yl)-2-butanone and its

metabolites containing chlorophenoxy

and triazole moieties (expressed as the

fungicide) in connection with use of the

pesticide under the section 18

emergency exemptions granted by EPA.

The tolerances will expire and are

revoked on the dates specified in the

following table:

Commodity

Parts

per

million

Expiration/revocation date

Artichokes .............. 0.6 September 1,

1999

Asparagus .............. 0.15 September 1,

1999

Chili peppers .......... 0.5 November 8,

1997

(c) Tolerances with regional

registrations. Tolerances with regional

registration are established for the

combined residues of the fungicide 1-(4-

chlorophenoxy)-3,3-dimethyl-1(1H1,2,4-triazol-l-yl)-2-butanone and its

metabolites containing chlorophenoxy

and triazole moieties (expressed as the

fungicide) in or on the following raw

agricultural commodities:

Commodity

Parts

per million

Raspberries ..................................... 2.0

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.800 [Removed]

b. In § 185.800 by transferring the

entries in the table and alphabetically

adding them to the table in paragraph

(a) of § 180.410, and by removing the

remainder of § 185.800.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 342, 348, and 701.

§ 186.800 [Removed]

b. In § 186.800 by transferring the

entries in the table and alphabetically

adding them to the table in paragraph

(a) of § 180.410, and by removing the

remainder of § 186.800.

[FR Doc. 97–23975 Filed 9-9-97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

43 CFR Part 1810

[WO–420–1050–00–24–1A]

RIN 1004–AC 81

Public Land Records

AGENCY: Bureau of Land Management,

Interior.

ACTION: Final rulemaking.

SUMMARY: This final rule amends Part

1810 of Title 43 of the Code of Federal

Regulations (CFR) by completely

removing Subpart 1813. That subpart

contains general information about

public land records and explains Bureau

of Land Management (BLM) practices.

Instead, we will place these internal

procedures in information brochures

and BLM’s manual system, which is

appropriate given the administrative

nature of Subpart 1813.

EFFECTIVE DATE: October 10, 1997.

ADDRESSES: You may send inquiries or

suggestions to: Director (630), Bureau of

Land Management, 1849 C Street, NW,

Washington, D.C. 20240.

FOR FURTHER INFORMATION CONTACT:

Frances Watson, Telephone: 202–452–

5006 (Commercial or FTS).

SUPPLEMENTARY INFORMATION:

I. Background

II. Final Rule as Adopted

III. Responses to Comments

IV. Procedural Matters

I. Background

One of the objectives of President

Clinton’s regulatory reform initiative is

to eliminate unnecessary regulations

from the CFR. To meet that objective,

BLM is removing from the CFR material

that provides general information about

public land records and explains BLM

practices. Instead, BLM will provide

this information in public information

releases and the BLM Manual, both of

which are available to the public, are

more detailed, and can be more easily

updated. Removing this material from

the CFR will not deprive the public of

any notice, right, administrative process

or information required by law.

The final rule published today is a

stage of the rulemaking process that will

culminate in the removal of the

regulations in 43 CFR Subpart 1813.

This rule was preceded by a proposed

rule that was published in the Federal

Register on December 23, 1996 (61 FR

67517). The BLM invited public

comments for 60 days, and received

three comments—one from a petroleum

association, one from a county

government agency, and one from a law

firm.

II. Final Rule as Adopted

The final rule completely removes 43

CFR subpart 1813, which contains BLM

procedures on maintaining the public

land records. Removing this material is

appropriate since it will continue to be

available to the public through other

means—informational brochures and

the BLM manual system. The final rule

is being published without change from

the December 23, 1996, proposed rule.

III. Responses to Comments

The three comments that we received

on the proposed rule expressed concern

about removing 43 CFR subpart 1813.

The commenters interpreted the

regulation to mean that BLM will no