Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations 28253

APPENDIX A: SUMMARY OF ACCEPTABLE DECISIONS

[Aerosol Propellants]

ODS being replaced Substitute Decision Comments

CFC–11, CFC–12, CFC–

114, HCFC–22,

HCFC–142b as aerosol

propellant.

HFC–227ea ........ Acceptable ......... Despite the relatively high global warming potential of this compound, the

Agency has listed this substitute as acceptable since it meets a specialized application in MDIs where other substitutes do not provide acceptable

performance.

[FR Doc. 98–13125 Filed 5–21–98; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300658; FRL–5790–1]

RIN 2070–AB78

Hydroxyethylidine Diphosphonic Acid;

Exemption From the Requirement of a

Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes an

exemption from the requirement of a

tolerance for residues of

hydroxyethylidine diphosphonic acid

(HEDP), when used as an inert

ingredient (stabilizer/ chelator) in

antimicrobial pesticide formulations

applied in or on raw agricultural

commodities. Ecolab, Inc. requested this

tolerance under the Federal Food, Drug

and Cosmetic Act (FFDCA), as amended

by the Food Quality Protection Act of

1996 (Pub. L. 104–170).

DATES: This regulation is effective May

22, 1998. Objections and requests for

hearings must be received by EPA on or

before July 21, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300658],

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–

300658], 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. 119, 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–

300658]. 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: Amelia M. Acierto, Registration

Division (7505W), 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) 308–8377, e-mail:

acierto.amelia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 17, 1997

(62 FR 66091) (FRL–5760–5), EPA

issued a notice pursuant to section 408

of the Federal Food, Drug, and Cosmetic

Act (FFDCA), 21 U.S.C. 346a(e)

announcing the filing of a pesticide

petition (PP 7E4922) for a tolerance

exemption by Ecolab Inc., 370 N.

Wabasha Street, St. Paul, Minnesota

55102. This notice included a summary

of the petition prepared by Ecolab Inc.,

the petitioner. There were no comments

received in response to the notice of

filing.

The petition requested that 40 CFR

180.1001(c) be amended by establishing

an exemption from the requirement of a

tolerance for residues of the inert

ingredient hydroxyethylidine

diphosphonic acid (HEDP), when used

as an inert ingredient (stabilizer and

chelator) in antimicrobial pesticide

formulations used in or on raw

agricultural commodities.

I. Risk Assessment and Statutory

Findings

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. . . .’’

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’’).
28254 Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations

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 hundredfold MOE is

based on the same rationale as the

hundredfold uncertainty factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term,’’ and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1–day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

the Food Quality Protection Act, 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

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 percent 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.

II. 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 HEDP and to make a

determination on aggregate exposure,

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

exemption from the requirement of a

tolerance for residues of HEDP when

used as an inert ingredient in

antimicrobial pesticide formulations

applied to raw agricultural

commodities. EPA’s assessment of the

dietary exposures and risks associated
Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations 28255

with establishing the tolerance

exemption 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 HEDP are

discussed below.

1. Acute toxicity. A rat acute oral

study with an LD50 of 2,400 mg/kg.

2. Genotoxicity. HEDP was reported to

be non-mutagenic in a Salmonella/

Mammalian microsome test or in a

L5178Y TK mouse lymphoma cell point

mutation assay, with and without

mammalian microsomal activation.

3. Subchronic toxicity— i. Dogs. In a

subchronic feeding study in beagle dogs

(4 dogs/sex/dose), HEDP was

administered at doses of 0, 1,000, 3,000,

or 10,000 ppm for 90 days. The NOEL

was 3,000 ppm (75 milligrams/

kilogram/day (mg/kg/day)) and the

Lowest Observed Effect Level (LOEL)

was 10,000 ppm (250 mg/kg/day based

on decreased weight gain in females,

and decreased testicular weight

accompanied by evidence of bilateral

focal degeneration of the testicular

germinal epithelium in males.

ii. Rats. In a subchronic feeding study

in rats, Sprague-Dawley strain rats were

fed HEDP at dietary concentrations of 0,

3,000, 10,000 and 30,000 ppm for 90

days. The NOEL was 10,000 ppm

(approximately 500 mg/kg/day) and the

LOEL was 30,000 ppm (approximately

1,500 mg/kg/day) based on decreased

body weight, decreased food

consumption, slight anemia, and

decreased heart, liver, and kidney

weights.

4. Developmental toxicity study. In a

developmental toxicity study, rabbits

were administered HEDP at doses of 0,

25, 50 and 100 mg/kg/day, either

incorporated into feed or by intubation

with water. The NOEL for both systemic

and developmental effects was 50 mg/

kg/day and the LOEL was 100 mg/kg/

day gavage dose based on decreased

maternal weight gain/ food

consumption and decreased fetal body

weights.

5. Reproductive toxicity study. In a

combined two-generation reproduction/

developmental toxicity study, rats (22

rats/sex/dose) were administered HEDP

at doses of 0, 0.1, and 0.5 percent in the

diet. The NOEL for developmental and

reproductive findings was 50 mg/kg/day

(0.1 percent in the diet) and the LOEL

was 250 mg/kg/day (0.5 percent in the

diet) based on reduced litter size in the

first litter (F1a) and an increase in

stillborn pups in the second liter (F1b).

These effects occurred in the absence of

maternal toxicity and were seen in both

reproductive litters of the first

generation.

B. Toxicological Endpoints

1. Acute toxicity. An acute dietary risk

assessment is not required because no

significant treatment-related effects

attributable to a single exposure (dose)

were seen in the oral studies conducted

with HEDP.

2. Short - and intermediate - term

toxicity. A short- and intermediate-term

risk assessment is not required for HEDP

since significant short- and

intermediate- term exposures are not

expected as a result of the proposed use

pattern.

3. Chronic toxicity. EPA has

established the RfD for HEDP at 0.05

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

reproductive/developmental toxicity

study in rats with a NOEL of 50 mg/kg/

day. An uncertainty factor of 1,000 was

used in the calculation of the RfD to

account for intraspecies variability

(tenfold uncertainty factor), interspecies

extrapolation (tenfold uncertainty

factor), lack of chronic toxicity/

carcinogenicity data (threefold

uncertainty factor), and the additional

sensitivity of infants and children

(threefold uncertainty factor). The

product of these four individual

uncertainty factors results in an overall

uncertainty factor of 1,000.

4. Carcinogenicity. A survey of the

open literature has not revealed any

studies as to the carcinogenicity of

HEDP. Since HEDP has been determined

to be nonmutagenic in genotoxicity

testing and no preneoplastic lesions

have been noted in any of the available

animal or human test data, it is expected

that the use of an additional threefold

uncertainty factor in the chronic risk

assessment of HEDP to account for the

lack of carcinogenicity data should be

protective of any possible cancer risk.

C. Exposures and Risks

1. From food and feed uses. Risk

assessments were conducted by EPA to

assess dietary exposures and risks from

HEDP as follows:

i. Acute exposure and risk. Since

there are no acute toxicological

concerns for HEDP, an acute dietary risk

assessment was not required.

ii. Chronic exposure and risk. For the

purpose of assessing chronic dietary

exposure from HEDP, EPA considered

the proposed use of HEDP as a

component of an antimicrobial pesticide

formulation at a concentration not to

exceed 1 percent of the formulation and

a maximum use rate of the antimicrobial

formulation used in fruit and vegetable

wash water of 1 ounce/16.4 gallons of

water. There are no established U.S.

tolerances for HEDP, and there are no

other registered uses for HEDP on food

or feed crops in the United States. In

conducting this exposure assessment,

EPA assumed that residues of 1 part per

billion (ppb) of HEDP would be present

in all raw agricultural commodities,

resulting in a large overestimate of

dietary exposure and protective of any

chronic dietary exposure scenario.

(Limted data provided by the petitioner

and prior estimations of dietary intake

made by the U.S Food and Drug

Administration (FDA) for the use of

HEDP in antimicrobial applications to

processed foods indicate that residues of

HEDP in the treated commodities would

be unlikely to exceed 1 ppb.) Based on

the assumption that residues would be

present at 1 ppb in all items consumed

in the diet, it is estimated that the

resultant dietary exposure would be

0.00004 mg/kg/day for adults (U.S.

population) and 0.0001 mg/kg/day for

children.

2. From drinking water— i. Acute

exposure and risk. Since there are no

acute toxicological concerns for HEDP,

an acute drinking water risk assessment

was not required.

ii. Chronic exposure and risk. For the

purposes of assessing chronic exposure

in drinking water, EPA has considered

the current use of HEDP as an

antiscalant in municipal drinking water

treatment systems at a maximum

concentration of 25 ppb in consumed

water. Based on a typical average daily

consumption of 2 liters of water/ day by

adults and 1 liter water/day by children.

The exposure to HEDP from drinking

water exposure would not be expected

to exceed 0.0007 mg/kg/day for adults

and 0.0025 mg/kg/day for children.

3. From non-dietary exposure. Since

there are no acute toxicological

concerns for HEDP, an acute nondietary

risk assessment was not required.

Chronic exposure and risk. While

non-dietary exposure to HEDP as a

result of its use in antimicrobial

pesticide formulations applied to raw

agricultural commodites is unlikely

other uses of HEPD for which nondietary exposure may result include its

use in various personal care and overthe-counter pharmaceutical products. It

is expected that the exposures

associated with these uses would not

exceed 0.0049 mg/kg/day for adults and

0.0204 mg/kg/day for children.
28256 Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations

4. Cumulative exposure to substances

with common mechanism of toxicity.

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

when considering whether to establish,

modify, or revoke a tolerance, the

Agency consider ‘‘available

information’’ concerning the cumulative

effects of a particular pesticide’s

residues and ‘‘other substances that

have a common mechanism of toxicity.’’

The Agency believes that ‘‘available

information’’ in this context might

include not only toxicity, chemistry,

and exposure data, but also scientific

policies and methodologies for

understanding common mechanisms of

toxicity and conducting cumulative risk

assessments. For most pesticides,

although the Agency has some

information in its files that may turn out

to be helpful in eventually determining

whether a pesticide shares a common

mechanism of toxicity with any other

substances, EPA does not at this time

have the methodologies to resolve the

complex scientific issues concerning

common mechanism of toxicity in a

meaningful way. EPA has begun a pilot

process to study this issue further

through the examination of particular

classes of pesticides. The Agency hopes

that the results of this pilot process will

increase the Agency’s scientific

understanding of this question such that

EPA will be able to develop and apply

scientific principles for better

determining which chemicals have a

common mechanism of toxicity and

evaluating the cumulative effects of

such chemicals. The Agency anticipates,

however, that even as its understanding

of the science of common mechanisms

increases, decisions on specific classes

of chemicals will be heavily dependent

on chemical specific data, much of

which may not be presently available.

Although at present the Agency does

not know how to apply the information

in its files concerning common

mechanism issues to most risk

assessments, there are pesticides as to

which the common mechanism issues

can be resolved. These pesticides

include pesticides that are

toxicologically dissimilar to existing

chemical substances (in which case the

Agency can conclude that it is unlikely

that a pesticide shares a common

mechanism of activity with other

substances) and pesticides that produce

a common toxic metabolite (in which

case common mechanism of activity

will be assumed).

EPA does not have, at this time,

available data to determine whether

HEDP has a common mechanism of

toxicity with other substances or how to

include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity, HEDP

does not appear to produce a toxic

metabolite produced by other

substances. For the purposes of this

tolerance action, therefore, EPA has not

assumed that HEDP has a common

mechanism of toxicity with other

substances.

D. Aggregate Risks and Determination of

Safety for U.S. Population

Using the extremely conservative

exposure assumptions described above,

EPA has concluded that aggregate

exposure to HEDP from all pesticide and

nonpesticide uses will not exceed 0.006

mg/kg/day for adults (12 percent of the

RfD) and 0.023 mg/kg/day for children

(46 percent of the RfD. EPA generally

has no concern for exposures below 100

percent 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 does not expect

the aggregate exposure to exceed 100

percent of the RfD. EPA therefore

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to HEDP residues.

E. Aggregate Risks and Determination of

Safety for Infants and Children

Safety factor for infants and children.

In assessing the potential for additional

sensitivity of infants and children to

residues of HEDP, 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 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. In either case, EPA generally

defines the level of appreciable risk as

exposure that is greater than 1/100 of

the NOEL in the animal study

appropriate to the particular risk

assessment. This hundredfold

uncertainty (safety) factor/MOE (safety)

is designed to account for inter-species

extraoplation and inter-species

variability. EPA believes that reliable

data support using the hundredfold

margin/factor, rather than the

thousandfold margin/factor, when EPA

has a complete data base under existing

guidleines, and when the severity of the

effect in infants or children, the potency

or unusual toxic properties of a

compound, or the quality of the

exposure data do not raise concerns

regarding the adequacy of the standard

margin/factor.

The following factors support

retention of a tenfold uncertainly factor:

(i) The reproductive effects were

observed at dose levels in which there

was no apparent maternal toxicity, (ii)

the study was not conducted in

accordance with OPP’s Subdivision F (

Hazard Evaluation: Humans and

Domestic Animals) Pesticide

Assessment Guidelines, and (iii) a

prenatal developmental toxicity study of

HEDP in rats conducted via the gavage

route of administration was not

available (the dietary developmental

toxicity study in rats which was

conducted as part of the reproductive

study did not completely meet

Subdivision F Pesticide Assessment

Guideline requirements. However, the

noted reproductive effects (decreased

average number of live fetuses and

increases in stillborn pups) were seen as

separate, single litter events of the first

generation but not of the second

generation which would render less

significance to a finding of a treatmentrelated effect. Taking into account that

in this case there are study deficiencies

not absent studies, the evidence of a

reproductive effects in the absence of

maternal toxicity is equivocal, and

developmental effects were observed in

rabbits at dose levels in which maternal

toxicity was not observed, EPA has

concluded that the tenfold uncertainty

factor for infants and children should be

reduced to a threefold uncertainty

factor.

III. Other Considerations

A. Analytical Enforcement Methodology

The Agency is establishing an

exemption from the requirement of a

tolerance without any numerical

limitation; therefore, the Agency has

concluded that an analytical method is

not required for enforcement purposes

for HEDP.
Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations 28257

B. International Residue Limits

No Codex maximum residue levels

have been established for HEDP.

IV. Conclusion

Therefore, an exemption from the

requirement of a tolerance is established

for residues of HEDP when used as an

inert ingredient (stabilizer/ chelator) in

antimicrobial pesticide formulations

applied to raw agricultural commodites

at a level not to exceed 1 percent of the

antimicrobial pesticide formulation.

V. 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 July 21, 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.

VI. Public Docket and Electronic

Submissions

EPA has established a record for this

rulemaking under docket control

number [OPP–300658] (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 119 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.

VII. Regulatory Assessment

Requirements

This final rule establishes an

exemption from the requirement of a

tolerance under FFDCA section 408(d)

in response to a petition submitted to

the Agency. 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(d), such as the exemption in this

final rule, do not require the issuance of

a proposed rule, the requirements of the

Regulatory Flexibility Act (RFA) (5

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

Nevertheless, the Agency has previously

assessed whether establishing

tolerances, exemptions from tolerances,

raising tolerance levels or expanding

exemptions might adversely impact

small entities and concluded, as a

generic matter, that there is no adverse

economic impact. The factual basis for

the Agency’s generic certification for

tolerance actions published on May 4,

1981 (46 FR 24950) and was provided

to the Chief Counsel for Advocacy of the

Small Business Administration.

VIII. 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.
28258 Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 /Rules and Regulations

Dated: May 8, 1998.

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 § 180.1001, in paragraph (c), the

table is amended by alphabetically

adding the inert ingredient

‘‘hydroxyethylidine diphosphonic acid

(HEDP)’’ to read as follows:

§ 180.1001 Exemptions from the

requirement of a tolerance.

* * * * *

(c) * * *

Inert ingredients Limits Uses

* * * * * * *

Hydroxyethylidine diphosphonic acid (HEDP) (CAS Reg. No.

2809–21–4).

For use in antimicrobial pesticide formulations at not

more than 1 percent.

Stabilizer, chelator

* * * * * * *

* * * * *

[FR Doc. 98–13603 Filed 5–21–98; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300659; FRL–5790–3]

RIN 2070–AB78

Bacillus Thuringiensis Subspecies

tolworthi Cry9C Protein and the

Genetic Material Necessary for its

Production in Corn; Exemption from

the Requirement of a Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This rule amends an

exemption from the requirement of a

tolerance for resid ues of the insecticide,

Bacillus thuringiensis subspecies

tolworthi Cry9C protein and the genetic

material necessary for its production in

corn for feed use only; as well as in

meat, poultry, milk, or eggs resulting

from animals fed such feed. Plant

Genetic Systems (America), Inc.

submitted a petition to the EPA under

the Federal Food, Drug and Cosmetic

Act (FFDCA) as amended by the Food

Quality Protection Act (FQPA) of 1996

requesting the exemption from the

requirement of a tolerance. This

regulation eliminates the need to

establish a maximum permissible level

for residues of this plant-pesticide in or

on corn used for feed; as well as in

meat, poultry, milk, or eggs resulting

from animals fed such feed.

EFFECTIVE DATE: This regulation is

effective May 22, 1998. Objections and

requests for hearings must be received

by EPA on or before July 21, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number [OPP–300659],

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–

300659], 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. 119, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may be submitted electronically by

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

electronic objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of electronic objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1/6.1 or

ASCII file format. All copies of

electronic objections and hearing

requests must be identified by the

docket number [OPP–300659]. No

Confidential Business Information (CBI)

should be submitted through e-mail.

Copies of electronic objections and

hearing requests on this rule may be

filed online at many Federal Depository

Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Mike Mendelsohn, Regulatory

Action Leader, Biopesticides and

Pollution Prevention Division (7511W),

Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460,

Office location, telephone number, and

e-mail: Room CS15–W29, 2800 Jefferson

Davis Highway, Arlington, VA, 703–

308–8715, e-mail:

mendelsohn.mike@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: Plant

Genetic Systems (America), Inc., 7200

Hickman Road, Suite 202, Des Moines,

IA 50322 has requested in pesticide

petition (PP 7F4826) the establishment

of an exemption from the requirement of

a tolerance for residues of the

insecticide Bacillus thuringiensis

subspecies tolworthi Cry9C protein and

the genetic material necessary for its

production in corn in or on all raw

agricultural commodities. A notice of

filing (FRL–5739–9) was published in

the Federal Register (62 FR 49224,

September 19, 1997), and the notice

announced that the comment period

would end on October 20, 1997; no

comments were received. Plant Genetic

Systems (America), Inc. submitted an

amendment to their petition on April

24, 1998 to request the establishment of

an exemption from the requirement of a

tolerance for residues of the insecticide

Bacillus thuringiensis subspecies

tolworthi Cry9C protein and the genetic

material necessary for its production in

corn only in corn used for feed; as well

as in meat, poultry, milk, or eggs

resulting from animals fed such feed.

This exemption from the requirement of

a tolerance will permit the marketing of

feed corn containing the plant-pesticide;

as well as meat, poultry, milk, or eggs

resulting from animals fed such feed.

The data submitted in the petition and

all other relevant material have been

evaluated. Following is a summary of

EPA’s findings regarding this petition as

required by section 408(d) of the Federal

Food, Drug and Cosmetic Act (FFDCA),

21 U.S.C. 346a, as recently amended by

the Food Quality Protection Act (FQPA),

Pub. L. 104–170.