Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations 65369

Dated: November 25, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

§ 180.443 [Amended]

2. In § 180.443, by amending

paragraph (b) in the table, for the

commodity ‘‘cucurbit vegetables’’ by

removing ‘‘November 30, 1997’’and

adding in its place ‘‘November 30,

1998’’.

[FR Doc. 97–32549 Filed 12–11–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300590; FRL–5759–5]

RIN 2070–AB78

Chlorothalonil; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

chlorothalonil in or on ginseng. 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

ginseng. This regulation establishes a

maximum permissible level for residues

of chlorothalonil and its metabolite 4-

hydroxy-2,5,6-

trichloroisophthalonitrile, expressed as

chlorothalonil, 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 December

31, 1998.

DATES: This regulation is effective

December 12, 1997. Objections and

requests for hearings must be received

by EPA on or before February 10, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300590],

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–

300590], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 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–

300590]. 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

a tolerance for residues of the fungicide

chlorothalonil and its 4-hydroxy-2,5,6-

trichloroisophthalonitrile metabolite,

expressed as chlorothalonil, in or on

ginseng at 0.10 parts per million (ppm).

This tolerance will expire and is

revoked on December 31, 1998. EPA

will publish a document in the Federal

Register to remove the revoked

tolerance from the Code of Federal

Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

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

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

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

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996) (FRL–5572–9).

New section 408(b)(2)(A)(i) of the

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

‘‘safe.’’ Section 408(b)(2)(A)(ii) defines

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

408(b)(2)(C) requires EPA to give special

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue....’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.
65370 Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations

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

Chlorothalonil on Ginseng and FFDCA

Tolerances

The state of Wisconsin availed itself

of the authority to declare a crisis

exemption to use chlorothalonil to

control the ginseng leaf and stem blight

caused by Alternaria panax. A. panax

may cause substantial losses of ginseng

yield if not controlled. Specific

emergency exemptions have been

granted for the use of mancozeb for

several years based on loss of efficacy of

iprodione due to development of

resistance in the pathogen to the latter

fungicide. The state argues that while

mancozeb affords good protection

during typical years, during years of

very heavy precipitation, as in 1996 and

1997, mancozeb is inadequate because it

is easily washed off plants by rain. In

this respect, the state claims,

chlorothalonil provides superior control

during very rainy summers. EPA has

authorized under FIFRA section 18 the

use of chlorothalonil on ginseng for

control of leaf and stem blight in

Wisconsin.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

chlorothalonil in or on ginseng. In doing

so, EPA considered the new safety

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

and EPA decided that the necessary

tolerance under FFDCA section 408(l)(6)

would be consistent with the new safety

standard and with FIFRA section 18.

Consistent with the need to move

quickly on the emergency exemption in

order to address an urgent non-routine

situation and to ensure that the resulting

food is safe and lawful, EPA is issuing

this tolerance without notice and

opportunity for public comment under

section 408(e), as provided in section

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

expire and is revoked on December 31,

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

residues of the pesticide not in excess

of the amounts specified in the

tolerance remaining in or on ginseng

after that date will not be unlawful,

provided the pesticide is applied in a

manner that was lawful under FIFRA.

EPA will take action to revoke this

tolerance earlier if any experience with,

scientific data on, or other relevant

information on this pesticide indicate

that the residues are not safe.

Because this tolerance is being

approved under emergency conditions

EPA has not made any decisions about

whether chlorothalonil meets EPA’s

registration requirements for use on

ginseng or whether a permanent

tolerance for this use would be

appropriate. Under these circumstances,

EPA does not believe that this tolerance

serves as a basis for registration of

chlorothalonil by a state for special local

needs under FIFRA section 24(c). Nor

does this tolerance serve as the basis for

any state other than Wisconsin 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 chlorothalonil, 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,
Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations 65371

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 three

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

ground water 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

(children 1 to 6 years 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 chlorothalonil and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

chlorothalonil and its metabolite 4-

hydroxy-2,5,6-

trichloroisophthalonitrile, expressed as

chlorothalonil, in or on ginseng at 0.10

ppm. EPA’s assessment of the dietary

exposures and risks associated with

establishing the tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by chlorothalonil

are discussed below. The nature of the

toxic effects caused by

hexachlorobenzene (HCB), a

contaminant of chlorothalonil, are also

discussed.

1. Acute toxicity. The lowest observed

effect level (LOEL) of 175 milligrams/

kilogram/day (mg/kg/day) (only dose

tested) from a 3-month rat study was

used for evaluating acute dietary risk

from chlorothalonil to all subgroups.

The LOEL was based on renal and

gastric lesions observed within 4 days of

testing. An uncertainty factor of 300 was

recommended since a LOEL instead of

a NOEL was used for the assessment.

No acute dietary endpoints have been

identified for HCB.

2. Short - and intermediate - term

toxicity. The NOEL of 600 mg/kg/day

highest dose tested (HDT) from a 21-day

dermal toxicity study in male Fischer

344 rats was recommended to assess

risks from short and intermediate-term

exposures to residues of chlorothalonil.

There is no toxicological endpoint

identified for short and intermediateterm exposure to HCB.

3. Chronic toxicity. EPA has

established the RfD for chlorothalonil at

0.018 mg/kg/day. This RfD is based on

a 2-year dog feeding study with a NOEL

of 1.8 mg/kg/day and an uncertainty

factor of 100 (based on increased

urinary bilirubin levels and kidney

vacuolated epithelium at 3.5 mg/kg/

day).

The EPA has established the RfD for

HCB at 0.0008 mg/kg/day. This RfD is

based on the NOEL of 0.08 mg/kg/day

from a 130-week feeding study in rats.

At the LEL of 0.29 mg/kg/day, there was

hepatic centrilobular basophilic

chromogenesis. An uncertainty factor of

100 was used to account for interspecies extrapolation and intra-species

variability.

4. Carcinogenicity. The OPP Cancer

Peer Review Committee (CPRC)

classified chlorothalonil as a Group B2

(probable human carcinogen) chemical

with a Q1* = 7.66 x 10-3 (mg/kg/day)-1.

The classification was based on
65372 Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations

forestomach tumors in mice and renal

tumors in rats. The Q1* was based upon

female rat renal (adenoma and/or

carcinoma) tumor rates. A 3/4 scaling

factor was used to determine the Q1*

from the rat data. HCB, an impurity in

chlorothalonil, is also classified as a

Group B2 chemical (probable human

carcinogen) with a Q1* = 1.02 (mg/kg/

day)-1. The classification was based on

positive results in hamsters and rats.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.275) for residues of

chlorothalonil and its metabolite 4-

hydroxy-2,5,6-

trichloroisophthalonitrile, expressed as

chlorothalonil, in or on a variety of raw

agricultural commodities at levels

ranging from 0.05 ppm in cocoa beans

and bananas, edible pulp to 15 ppm in

celery and papayas. There are no

established tolerances on meat, milk,

poultry and eggs. Risk assessments were

conducted by EPA to assess dietary

exposures and risks from chlorothalonil

as presented below. Ginseng is not

presently represented in the Dietary

Risk Evaluation System (DRES) data

files because of very low consumption

in the U.S. Thus, the dietary exposure

analysis does not include a contribution

for ginseng. The consumption of ginseng

is not expected to significantly alter

exposure.

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 used

tolerance level residues ( published and

pending tolerances included). The

resulting high-end exposure estimate of

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

only) MOE of 1,500 for infants < 1 year

old and children 1-6 years old. This

should be viewed as a conservative risk

estimate.

ii. Chronic exposure and risk. For the

chronic dietary risk assessment, the

Agency used anticipated residue data.

The anticipated residues based on

existing chlorothalonil tolerances

(published and pending) result in an

anticipated residue contribution (ARC)

that is equivalent to percentages of the

RfD that range from 19.8% for nonnursing infants to 85.8% for children 1

to 6 years old.

Estimates for HCB result in an ARC

that is equivalent to percentages of the

RfD that range from 0.01% for nonnursing infants to 0.05% for children 1

to 6 years old. Residues of HCB were

estimated to be present at a level not

exceeding 0.05% (the maximum,

allowed in chlorothalonil formulations)

of the residues of chlorothalonil.

2. From drinking water. Based on

available data used in EPA’s assessment

of environmental risk, chlorothalonil is

not persistent and is moderately mobile.

Health advisory levels for chlorothalonil

in drinking water have been established

as follows: for a 10 kg child, the one day

finalized level and the long term level

is 0.2 mg/L; for a 70 kg adult, the long

term is 0.5 kg/L. No lifetime health

advisory level has been established for

chlorothalonil, but the Office of

Drinking Water estimates that a long

term average chlorothalonil

concentration of 150 μg/L would

correspond to an additional lifetime

carcinogenic risk of 10-4. Consequently,

a concentration of 1.5 μg/L would

correspond to a lifetime carcinogenic

risk of 10-6. Chlorothalonil is not

currently regulated under the Safe

Drinking Water Act (SDWA), therefore

water supply systems are not required to

sample and analyze for it. The

intermediate soil/water partitioning of

chlorothalonil should make the primary

treatment processes employed by most

surface water source supply systems at

least partially effective in removing it.

Ground water. Degradates

(metabolites) of chlorothalonil, not

chlorothalonil itself, have been found in

ground water in the states of New York,

Massachusetts, Florida, Maine, and

California (U.S. HED, 1993). The

reported metabolites (SDS-46851, SDS47525, SDS-3701, and SDS-19221) were

measured at the highest combined

concentration of approximately 16 ppb

in New York’s Suffolk County (Long

Island) in 1981. It is not clear how the

use of chlorothalonil in New York

compares to use in other areas, but it is

expected that the levels of

chlorothalonil metabolites detected in

the ground water in New York are

unrepresentatively high compared to the

country as a whole. A small-scale

ground water monitoring study is

underway, and will give the Agency a

more quantitative measure of the ground

water contamination potential.

Surface water. Chlorothalonil can

contaminate surface water at application

via spray drift. The intermediate soil/

water partitioning of chlorothalonil

indicates that its concentration in

suspended and bottom sediment will be

substantially greater than its

concentration in water.

The following surface water label

advisory is required for chlorothalonil:

Chlorothalonil can contaminate surface

water through spray drift. Under some

conditions, chlorothalonil may also have a

high potential for runoff into surface water

(via both dissolution in runoff water and

adsorption to eroding soil), for several weeks

to months post-application. These include

poorly draining or wet soils with readily

visible slopes toward adjacent surface waters,

frequently flooded areas, areas over-laying

extremely shallow ground water, areas with

in-field canals or ditches that drain to surface

water, areas not separated from adjacent

surface waters with vegetated filter strips,

and highly erodible soils.

The South Florida Water Management

District (SFWMD; Miles and Pfeuffer

1994) summarized chlorothalonil

detections in samples collected every 2

to 3 months from 27 surface water sites

within the SFWMD from November

1988 through November 1993.

Approximately 810 samples were

collected. Chlorothalonil was detected

in 25 samples at concentrations ranging

from 0.003 to 0.035 μg/L (0.003 ppb to

0.035 ppb).

Exposures and risks. The Agency does

not have sufficient data to complete a

comprehensive drinking water risk

assessment for the potential of

chlorothalonil and its degradates to

contaminate ground water. For this

drinking water risk assessment the

Agency assumed that the metabolites of

chlorothalonil have the same toxicity as

the parent chlorothalonil and used the

highest measured concentration levels

to calculate acute and chronic risks from

drinking water exposures to residues of

chlorothalonil. The Agency also

assumed that adults weighing 70 kg

consume 2 liters of drinking water per

day while children weighing 10 kg

drink 1 liter. The acute drinking water

risk was calculated by dividing the

LOEL identified for acute dietary risk

assessment by the exposure from

drinking water sources. The chronic risk

for drinking water was calculated by

comparing exposure from drinking

water sources to the appropriate RfD.

The following risk assessments

should be considered as worst case

scenarios. As the necessary data are

received, the risk assessments will be

reviewed and evaluated based on the

new data.

i. Acute exposure and risk— Ground

water. In order to calculate acute

drinking water risk, the highest

concentration detected in ground water

(16 ppb) was compared to the acute

dietary exposure LOEL of 175 mg/kg/

day. Acute exposures were estimated to

be 0.0016 mg/kg/day for children and

0.00046 mg/kg/day for adults. The

corresponding MOEs were estimated as

109,375 for children and 380,435 for

adults.

Surface water. The available surface

water monitoring information was used

to perform an exposure assessment of
Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations 65373

surface water as a drinking water

source. The highest measured

concentration (0.035 μg/L) and the acute

dietary LOEL were used to estimate

exposures and risks. Exposures were

estimated to be 0.000035 mg/kg/day for

children and 0.00001 mg/kg/day for

adults. The corresponding MOEs were

estimated as 5,000,000 for children and

17,500,000 for adults.

The large MOEs provide a reasonable

certainty of no harm from the potential

exposures associated with

chlorothalonil in water.

Acute drinking water risk to HCB was

not calculated since no acute dietary

endpoint has been identified for HCB.

ii. Chronic exposure and risk—

Ground water. The highest

concentration detected in ground water

(16 ppb) and the RfD for chlorothalonil

were used to estimate exposures and

risks. The Agency estimated that

chronic dietary risks from drinking

water will utilize 8% of the RfD for

children and 2% of the RfD for adults.

Surface water. The highest measured

concentration (0.035 μg/L) from the

available surface water monitoring data

and the RfD for chlorothalonil were

used to estimate exposures and risks.

The Agency estimated that chronic

dietary risks from surface water

exposures to residues of chlorothalonil

will utilize < 1% of the RfD for both

children and adults.

To estimate the chronic dietary risk

from exposures to HCB, concentrations

for chlorothalonil were assumed to be

contaminated with 0.05% HCB. The

resulting concentration was compared

to the RfD for HCB (0.0008 mg/kg/day).

The Agency estimated that chronic

dietary risks from surface water

exposures to residues of HCB will

utilize < 1% of the RfD for both children

and adults.

3. From non-dietary exposure.

Chlorothalonil is currently registered for

use on the following residential nonfood sites: turf, lawn, trees, grasses,

bulbs, plants, and shrubs. Indoor uses

include: paints, coatings, adhesives,

wood treatments, and resin emulsions.

The Agency currently lacks

residential-related exposure data to

complete a comprehensive residential

risk assessment for many pesticides,

including chlorothalonil.

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).

Chlorothalonil

(tetrachloroisophthalonitrile) is a

member of the substituted aromatics

class of pesticides (George W. Ware, The

Pesticide Book, 4th edition, page 144,

Thomson Publications, 1994). Other

members of this class include

pentachloronitrobenzene (PCNB) and

2,6-dichloro-4-nitroaniline (dicloran,

DCNA).

EPA does not have, at this time,

available data to determine whether

chlorothalonil has a common

mechanism of toxicity with other

substances or how to include this

pesticide in a cumulative risk

assessment. For the purposes of this

tolerance action, therefore, EPA has not

assumed that chlorothalonil 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 overall U.S.

population the calculated MOE value

(food) is 2,000 for chlorothalonil. For

acute drinking water risk, the calculated

MOE for adults, based on ground water

monitoring data, is 380,435. The acute

aggregate risk for general U.S.

population is 1,163 (175 mg/kg/day ÷

0.15046 mg/kg/day). The acute aggregate

risk for chlorothalonil for all population

subgroups is below HED’s level of

concern.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to chlorothalonil from food

and water will utilize ≈46.5% (44.5%

from food + ≈ 2% from water) of the RfD

for the U.S. population. The aggregate

exposure to HCB from food and water

will utilize ≈1.03% (0.03% from food +

≈1% from water) of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is children 1 to 6 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. EPA

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to chlorothalonil and

HCB 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

chlorothalonil short and intermediateterm exposure scenarios may exist.

However, the Agency currently lacks

sufficient residential-related exposure

data to complete a comprehensive

residential risk assessment for

chlorothalonil.

D. Aggregate Cancer Risk for U.S.

Population

The cancer risk from food uses of

chlorothalonil (a B2 carcinogen with a

Q1* of 7.66 x 10-3 (mg/kg/day)-1) for the

general U.S. population was estimated

as 1.1 x 10-6 (upper bound). The

calculation was based on ARC

estimates. EPA used all the published,

pending and new uses for chlorothalonil
65374 Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations

and substracted the risk figures from

consumption of meat and milk

products. Residues of chlorothalonil per

se are not expected to transfer from feed

items to meat and milk, but residues of

the 4-hydroxy metabolite (which is not

of carcinogenic concern) could occur in

these commodities. Thus, there is no

carcinogenic risk attributable to

chlorothalonil from its use on livestock

feed items.

The dietary (food) cancer risk from

HCB (a B2 carcinogen with a Q1* of 1.02

(mg/kg/day)-1) for the general U.S.

population was estimated as 3.6 x 10-7

(upper bound). The concentrations for

chlorothalonil were assumed to be

contaminated with 0.05% HCB. The

calculation was based on ARC estimates

and all the published, pending and new

uses for chlorothalonil.

The drinking water cancer risk from

exposure to chlorothalonil residues was

estimated as 2 x 10-7 for children and 7

x 10-8 for adults. These estimates are

based on the highest measured

concentration from the available surface

water monitoring data. Only metabolites

of chlorothalonil have been found in

ground water. These metabolites are not

of carcinogenic concern, therefore an

assessment of the cancer risks

associated with dietary exposures to

chlorothalonil from ground water

sources was not conducted. The

drinking water cancer risk from

exposure to HCB residues was estimated

as 1 x 10-7 for children and 5 x 10-9 for

adults. The concentrations for

chlorothalonil were assumed to be

contaminated with 0.05% HCB.

For the drinking water risk

assessment the Agency assumed that

water comes from the same source

containing the same contaminant level

and is consumed throughout a 36-year

period. This is extremely conservative,

since it is likely that frequency and

amounts of chlorothalonil used vary

widely over this time, and most of the

U.S. population moves at some time and

does not live in the same area, drinking

from the same water source for a 36-year

period. Therefore, the risk to both adults

and children from drinking water is

likely an over-estimate.

The Agency concludes that the

aggregate (food + water) cancer risks

from exposures to chlorothalonil and

HCB do not exceed the levels of

concern.

E. Aggregate Risks and Determination of

Safety for Infants and Children

1. Safety factor for infants and

children— i. In general. In assessing the

potential for additional sensitivity of

infants and children to residues of

chlorothalonil, EPA considered data

from developmental toxicity studies in

the rat and rabbit and a 2-generation

reproduction study in the rat. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

maternal pesticide exposure during

gestation. Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the data base 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—

Rats. The maternal (systemic) NOEL

was 100 mg/kg/day, based on increased

mortality and reduced weight gain at the

LOEL of 400 mg/kg/day. The

developmental (fetal) NOEL was 100

mg/kg/day, based on increase in total

resorptions and resorptions per dam

with related increase in

postimplantation loss at the LOEL of

400 mg/kg/day.

Rabbits. The maternal (systemic)

NOEL was 10 mg/kg/day, based on

reductions in weight gain and food

consumption during dosing at the LOEL

of 20 mg/kg/day. The developmental

(fetal) NOEL was 20 mg/kg/day (HDT).

iii. Reproductive toxicity study—

Rats. In the 2-generation reproductive

toxicity study in rats, the maternal

(systemic) NOEL was less than 38 mg/

kg/day lowest dose tested (LDT), based

on hyperplasia of renal and forestomach

tissues at the LOEL of 38 mg/kg/day.

The reproductive/developmental (pup)

NOEL was 115 mg/kg/day, based on

decreased pup weight on day 21 of

lactation and a suggestive increase in

the incidence of neonatal renal pelvis

dilation in the F1a generation at the

LOEL of 234 mg/kg/day.

iv. Pre- and post-natal sensitivity. The

toxicological data base for evaluating

pre- and post-natal toxicity for

chlorothalonil 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. In these studies, the fetal or pup

NOELs occur at or above the maternal

NOELs indicating that there is no extrasensitivity for infants and children.

v. Conclusion. Based on the above,

HED concludes that reliable data

support use of the standard uncertainty

factor of 100 and that an additional

safety factor is not needed to protect

infants and children.

2. Acute risk. The acute dietary MOE

(food) was calculated to be 1,500 for

infants (<1 year), 1,500 for children (1-

6 years), and 3,000 for females 13+ years

(accounts for both maternal and fetal

exposure). The acute aggregate MOE

(food and water) for the most highly

exposed subpopulation (children 1 - 6

years old) was calculated to be 868.

These MOE calculations were based on

the systemic LOEL in rats of 175 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 13+

years provides assurance that there is a

reasonable certainty of no harm for both

females 13+ years and the pre and postnatal development of infants.

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate dietary (food + water)

exposure to chlorothalonil will utilize

percentages of the RfD that range from

27.8% (19.8% for food + 8% for water)

for nursing infants, up to 93.8% (85.8%

for food + 8% for water) for children 1-

6 years old.

The percentage of the RfD that will be

utilized by aggregate exposure food +

water to residues of HCB ranges from

≈1.01% for nursing infants, up to

≈1.05% for children 1-6 years 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. EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to chlorothalonil residues.
Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations 65375

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants

and animals is adequately understood.

The residues of concern are

chlorothalonil and its metabolite 4-

hydroxy-2,5,6-trichloroisophthalonitrile

is an impurity in chlorothalonil

products.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

(gas chromatography-electron capture

detection) is available in PAM II

(Method I) to enforce the tolerance

expression.

C. Magnitude of Residues

Residues of chlorothalonil and its

metabolite 4-hydroxy-2,5,6-

trichloroisophthalonitrile are not

expected to exceed 0.10 ppm in/on

ginseng as a result of this section 18 use.

Secondary residues are not expected in

animal commodities as no feed items

are associated with this section 18 use.

D. International Residue Limits

There are no Codex proposals,

Canadian limits, or Mexican limits for

chlorothalonil on ginseng.

E. Rotational Crop Restrictions

EPA has determined that rotational

crop studies will not be required for

uses of pesticides on ginseng.

VI. Conclusion

Therefore, the tolerance is established

for chlorothalonil and its metabolite 4-

hydroxy-2,5,6-trichloroisophthalonitrile

(expresed as chlorothalonil) in ginseng

at 0.10 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 February 10,

1998, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

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–300590] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis 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 a timelimited tolerance under FFDCA section

408(l)(d). 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 on the

basis of a petition under FFDCA section

408 (l)(6), such as the tolerance in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

U.S.C. 601 et seq.) do not apply.

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for
65376 Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Rules and Regulations

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).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: December 1, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.275, by adding a heading

to paragraph (a); by redesignating

paragraph (b) as paragraph (c) and

adding a heading; by adding new

paragraph (b); and by adding and

reserving paragraph (d) with a heading

to read as follows:

§ 180.275 Chlorothalonil; tolerances for

residues.

(a) General . * * *

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for chlorothalonil and its metabolite 4-

hydroxy-2,5,6-trichloroisophthalonitrile

(expresed as chlorothalonil) 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

Ginseng .................................................................................................................................... 0.10 12/31/98

(c) Tolerances with regional

registrations. * * *

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–32548 Filed 12–11–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF THE INTERIOR

Bureau of Land Management

43 CFR Parts 3740, 3810, and 3820

[WO–340–1220–00–24 1A]

RIN 1004–AD05

Multiple Use, Mining; Mining Claims

Under the General Mining Laws

AGENCY: Bureau of Land Management,

Interior.

ACTION: Final rule.

SUMMARY: The Bureau of Land

Management (BLM) is removing several

obsolete or unnecessary regulations, and

revising regulations concerning mining

on Papago Indian Reservation lands.

The regulations BLM is removing

concern certain programs under the

Multiple Minerals Development Act:

claimant’s rights; opening of Helium

reserves to mining location and mineral

leasing; and regulations under the

statute entitled ‘‘Mining Rights in

Prescott National Forest’’ concerning

mining in the watershed of the city of

Prescott, Arizona. Each of the

regulations being removed is

unnecessary or obsolete, either because

it describes programs which no longer

exist or because it contains

requirements already achieved by

statutes or other applicable regulations.

Removing these items will have no

impact on BLM customers or the public

at large.

EFFECTIVE DATE: January 12, 1998.

ADDRESSES: You may send inquiries or

suggestions to: Director (630), Bureau of

Land Management, 1849 C Street, N.W.,

Washington, DC 20240.

FOR FURTHER INFORMATION CONTACT:

Roger Haskins, Bureau of Land

Management, Solid Minerals Group,

1849 C Street, N.W., Washington, DC

20240; Telephone: 202–452–0355.

SUPPLEMENTARY INFORMATION:

I. Background and Discussion of Final Rule

as Adopted

II. Responses to Comments

III. Procedural Matters

I. Background and Discussion of Final

Rule as Adopted

The regulations that are being

removed are obsolete and unnecessary,

and therefore can be eliminated without

negative consequences.

Subpart 3744 concerns the rights of

leasable minerals mining claimants.

These rights are derived from the

Multiple Mineral Development Act, 30

U.S.C. 521 et seq. (the Leasing Act).

However, rather than implementing or

interpreting the Act, subpart 3744

merely quotes Sections 7(d) and 8 of the

Act, 30 U.S.C. 527(d), 528. The

regulation consists entirely of

duplicated statutory language and adds

nothing to the protections of mining

claimants’ rights already contained in

the statute. Because those rights are

preserved by the statute and not the

regulation, this regulation serves no

substantive purpose, and can be deleted

without any impact on the regulated

community or the United States.

Subpart 3745, concerning the

conditions for opening Helium Reserves

to mining location and mineral leasing,

also consists of unnecessary recitation

of the Leasing Act. 43 CFR 3745.1(a) is

merely a direct quote of section 9 of the

Act, 30 U.S.C. 529. In addition, 43 CFR

3745.1(b) contains language not derived

from the Act, asserting that applications

filed prior to published notice to open

the helium reserves will confer no

rights. However, this provision is

completely obsolete and without any

substantive importance. Merely filing an

application cannot confer any rights

until the application is approved.

Furthermore, Helium Reserves Numbers

1 and 2 were opened in 1955, have since

been withdrawn, and BLM has

determined that no pre-existing

applications under this subpart

currently exist. Therefore, because this

regulation contains only duplicated

statutory language and obsolete

provisions, it can be deleted without