49918 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

GLOBAL PACKAGE LINK SERVICE TO

HONG KONG—Continued

Weight not over (pounds)

Annual volume

first 100,000

packages—no

discount, premium service

(dollars)

2 ........................................ 18.75

3 ........................................ 22.00

4 ........................................ 25.20

5 ........................................ 28.45

6 ........................................ 31.65

7 ........................................ 34.90

8 ........................................ 38.10

9 ........................................ 41.35

10 ...................................... 44.55

11 ...................................... 47.80

12 ...................................... 51.00

13 ...................................... 54.25

14 ...................................... 57.45

15 ...................................... 60.70

16 ...................................... 63.90

17 ...................................... 67.15

18 ...................................... 70.35

19 ...................................... 73.60

20 ...................................... 76.80

21 ...................................... 80.05

22 ...................................... 83.25

23 ...................................... 86.50

24 ...................................... 89.70

25 ...................................... 92.90

26 ...................................... 96.15

27 ...................................... 99.35

28 ...................................... 102.60

29 ...................................... 105.80

30 ...................................... 109.05

31 ...................................... 112.25

32 ...................................... 115.50

33 ...................................... 118.70

34 ...................................... 121.95

35 ...................................... 125.15

36 ...................................... 128.40

37 ...................................... 131.60

38 ...................................... 134.85

39 ...................................... 138.05

40 ...................................... 141.30

41 ...................................... 144.50

42 ...................................... 147.75

43 ...................................... 150.95

44 ...................................... 154.20

Number of pieces in contract year Discount

1–100,000 .......................... None

100,001+ ............................ 3 percent of

base rate.

* * * * *

Stanley F. Mires,

Chief Counsel Legislative.

[FR Doc. 97–25356 Filed 9–23–97; 8:45 am]

BILLING CODE 7710–12–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300545; FRL–5741–2]

RIN 2070–AB78

Maneb; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

maneb (manganous

ethylenebisdithiocarbamate), calculated

as zinc ethylenebisdithiocarbamate, and

its metabolite ethylenethiourea in or on

walnuts. This action is in connection

with a crisis exemption declared by the

state of California under section 18 of

the Federal Insecticide, Fungicide, and

Rodenticide Act authorizing use of the

pesticides on walnuts in California. This

regulation establishes a maximum

permissible level for residues of maneb

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 June 15, 1998.

DATES: This regulation is effective

September 24, 1997. Objections and

requests for hearings must be received

by EPA on or before November 24, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300545],

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–

300545], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300545]. 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: Libby Pemberton, 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) 308-9364, e-mail:

pemberton.libby@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

tolerances for residues of the fungicide

maneb (manganous

ethylenebisdithiocarbamate), calculated

as zinc ethylenebisdithiocarbamate and

its metabolite ethylenethiourea, in or on

walnuts at 0.05 part per million (ppm).

This tolerance will expire and is

revoked on June 15, 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).
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49919

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.

Because decisions on section 18-

related tolerances must proceed before

EPA reaches closure on several policy

issues relating to interpretation and

implementation of the FQPA, EPA does

not intend for its actions on such

tolerance to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for Maneb on

Walnuts and FFDCA Tolerances

On February 24, 1997, the California

Department of Pesticide Regulation

availed itself of the authority to declare

the existence of a crisis situation within

the state, thereby authorizing use under

FIFRA section 18 of maneb on walnuts

for control of bacterial blight. Currently,

copper based bactericides are the only

registered products for control of this

disease. The increase of walnut blight

since 1992 is attributed to the

development of a tolerance to copper

based bactericides. The state has

demonstrated that copper resistant

bacteria have become economically

important, with a potential 55,000 acres

affected. EPA has authorized under

FIFRA section 18 the use of maneb on

walnuts for control of bacterial blight in

California. After having reviewed the

submission, EPA concurs that

emergency conditions exist for this

state.

As part of its assessment of this

emergency exemption, EPA assessed the

potential risks presented by residues of

maneb (calculations based on its

metabolite ethylenethiourea) and its

metabolite in or on walnuts. 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 June 15, 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 walnuts 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 maneb meets EPA’s registration

requirements for use on walnuts 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 maneb 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 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 maneb, 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.
49920 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term

and mutagenicity studies and structure

activity relationship. Once a pesticide

has been classified as a potential human

carcinogen, different types of risk

assessments (e.g., linear low dose

extrapolations or MOE calculation based

on the appropriate NOEL) will be

carried out based on the nature of the

carcinogenic response and the Agency’s

knowledge of its mode of action.

2. Differences in toxic effect due to

exposure duration. The toxicological

effects of a pesticide can vary with

different exposure durations. EPA

considers the entire toxicity data base,

and based on the effects seen for

different durations and routes of

exposure, determines which risk

assessments should be done to assure

that the public is adequately protected

from any pesticide exposure scenario.

Both short and long durations of

exposure are always considered.

Typically, risk assessments include

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

term’’, and ‘‘chronic’’ risks. These

assessments are defined by the Agency

as follows.

Acute risk, by the Agency’s definition,

results from 1-day consumption of food

and water, and reflects toxicity which

could be expressed following a single

oral exposure to the pesticide residues.

High end exposure to food and water

residues are typically assumed.

Short-term risk results from exposure

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

and therefore overlaps with the acute

risk assessment. Historically, this risk

assessment was intended to address

primarily dermal and inhalation

exposure which could result, for

example, from residential pesticide

applications. However, since enaction of

FQPA, this assessment has been

expanded to include both dietary and

non-dietary sources of exposure, and

will typically consider exposure from

food, water, and residential uses when

reliable data are available. In this

assessment, risks from average food and

water exposure, and high-end

residential exposure, are aggregated.

High-end exposures from all 3 sources

are not typically added because of the

very low probability of this occurring in

most cases, and because the other

conservative assumptions built into the

assessment assure adequate protection

of public health. However, for cases in

which high-end exposure can

reasonably be expected from multiple

sources (e.g. frequent and widespread

homeowner use in a specific

geographical area), multiple high-end

risks will be aggregated and presented

as part of the comprehensive risk

assessment/characterization. Since the

toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1-7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

groundwater or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

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

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(non-nursing infants (<1 year old) was

not regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

Consistent with section 408(b)(2)(D),

EPA has reviewed the available

scientific data and other relevant

information in support of this action,

EPA has sufficient data to assess the

hazards of maneb and to make a

determination on aggregate exposure,

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

time-limited tolerance for residues of

maneb (manganous

ethylenebisdithiocarbamate) calculated

as zinc ethylenebisdithiocarbamate and

its metabolite ethylenethiourea on

walnuts at 0.05 ppm. EPA’s assessment

of the dietary exposures and risks

associated with establishing the

tolerance follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by maneb (based on

calculations on its metabolite,

ethylenethiourea) are discussed below.

1. Acute toxicity. The acute dietary

risk assessment is being conducted for

ethylenethiourea (ETU) rather than

maneb, since the NOEL for acute dietary

risk for ETU is 4 times lower (5 mg/kg/
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49921

day) than the NOEL for acute dietary

risk for maneb (20 mg/kg/day).

Therefore, an acceptable MOE for ETU

will also be protective of exposure to

maneb. The oral developmental NOAEL

(No-observed-adverse-effect-level) in

rats for ETU is 5 mg/kg/day, based on

a threshold finding of delayed

ossification in the fetal skeletal

structures at the NOAEL. The NOEL is

more correctly identified as a slightly

lower dose level which is close to a

threshold NOAEL in the developmental

study. The EDBC PD-4 stated that MOEs

could be calculated from the 5 mg/kg/

day NOAEL, which was close to the

NOEL, and was the lowest dose tested.

2. Short - and intermediate - term

non-dietary toxicity. OPP recommends

use of the systemic NOEL of 100 mg/kg/

day from the 3-week dermal toxicity

study in rabbits. At the LOEL of 300 mg/

kg/day, there were slightly increased

thyroid weights and follicular cell

hypertrophy of the thyroid.

3. Chronic toxicity. EPA has

established the RfD for ETU at 0.00008

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

This RfD is based on the LOEL of 0.25

mg/kg/day due to thyroid hyperplasia in

a 2-year rat feeding study, with an

uncertainty factor of 3,000. The

uncertainty factor of 3,000 was based on

a factor of 3 for absence of a NOEL for

ETU, a factor of 10 for data gaps for

ETU, and a factor of 100 to take into

accoutn inter- and intra-species

variability.

4. Carcinogenicity. Maneb has been

classified as a Group B2, probable

human carcinogen, based on evidence of

thyroid tumors in rats and liver tumors.

The Q1 * for quantitation of human oral

risk is 0.0601 (mg/kg/day)-1 for the

carcinogenic metabolite, ETU.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.110) for the residues of maneb

(manganous

ethylenebisdithiocarbamate), calculated

as zinc ethylenebisdithiocarbamate, in

or on a variety of raw agricultural

commodities, including almonds at 0.1

ppm. Risk assessments were conducted

by EPA to assess dietary exposures and

risks from and maneb as follows:

i. Acute exposure and risk. Acute

dietary risk assessments are performed

for a food-use pesticide if a toxicological

study has indicated the possibility of an

effect of concern occurring as a result of

a one day or single exposure. The high

end dietary exposure for the population

subgroup of concern, females 13+ years

old, is 0.000036 mg/kg/day, which

results in an MOE of 5,000. Maximum

field trial residue data values were used

to calculate the MOE. This is considered

a partially refined risk estimate.

ii. Chronic exposure and risk. The

chronic exposure estimate for the

general population is 0.000020 mg/kg/

day and the anticipated residue

contribution (ARC) as apercentage of the

RfD is 24.4%.

2. From drinking water. There is no

established Maximum Concentration

Level (MCL) for residues of maneb in

drinking water. No drinking water

health advisory levels have been

established for maneb. Environmental

fate studies suggest that maneb is

moderately persistent and has moderate

potential to leach into ground water.

Maneb could potentially leach to

groundwater and run off to surface

water under certain environmental

conditions.

Chronic exposure and risk. Because

the Agency lacks sufficient waterrelated exposure data to complete a

comprehensive drinking water risk

assessment for many pesticides, EPA

has commenced and nearly completed a

process to identify a reasonable yet

conservative bounding figure for the

potential contribution of water-related

exposure to the aggregate risk posed by

a pesticide. In developing the bounding

figure, EPA estimated residue levels in

water for a number of specific pesticides

using various data sources. The Agency

then applied the estimated residue

levels, in conjunction with appropriate

toxicological endpoints (RfD’s or acute

dietary NOEL’s) and assumptions about

body weight and consumption, to

calculate, for each pesticide, the

increment of aggregate risk contributed

by consumption of contaminated water.

While EPA has not yet pinpointed the

appropriate bounding figure for

exposure from contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause maneb to exceed the RfD

if the tolerance being considered in this

document were granted. The Agency

has therefore concluded that the

potential exposures associated with

maneb in water, even at the higher

levels the Agency is considering as a

conservative upper bound, would not

prevent the Agency from determining

that there is a reasonable certainty of no

harm if the tolerance is granted.

3. From non-dietary exposure. Maneb

is currently registered for use on the

following residential non-food sites:

turf, lawn, trees, and shrubs.

i. Acute exposure and risk. EPA

generally will not include residential or

other non-dietary exposure as a

component of the acute exposure

assessment. Theoretically, it is also

possible that a residential, or other nondietary, exposure could be combined

with the acute total dietary exposure

from food and water. However, the

Agency does not believe that aggregating

multiple exposure to large amounts of

pesticide residues in the residential

environment via multiple products and

routes for a one day exposure is a

reasonably probable event. It is highly

unlikely that, in one day, an individual

would have multiple high-end

exposures to the same pesticide by

treating their lawn and garden, treating

their house via crack and crevice

application, swimming in a pool, and be

maximally exposed in the food and

water consumed. Additionally, the

concept of an acute exposure as a single

exposure does not allow for including

post-application exposures, in which

residues decline over a period of days

after application. Therefore, the Agency

believes that residential exposures are

more appropriately included in the

short-term exposure scenario discussed

below.

ii. Chronic exposure and risk. The

Agency has concluded that a chronic

residential exposure scenario does not

exists for non-occupational uses of

maneb.

iii. Short- and intermediate-term

exposure and risk. There are residential

uses of maneb and EPA acknowledges

that there may be short and

intermediate-term non-occupational

exposure scenarios. The EPA has

identified a toxicity endpoint for short

and intermediate term non-occupational

risks. However, no acceptable reliable

exposure data to assess the potential

risks are available at this time. Based on

the level of the short and intermediateterm endpoints, the Agency does not

expect the short and intermediate-term

aggregate risk to exceed the level of

concern.

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
49922 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

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

maneb 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, maneb

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 maneb has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

1. Acute risk. The MOE for females

13+ years was calculated to be 5,000.

Therefore, aggregate acute risk estimates

do not exceed the Agency’s level of

concern.

2. Chronic risk. Using the ARC

exposure assumptions described above,

EPA has concluded that aggregate

exposure to maneb from food will

utilize 24.4% of the RfD for the U.S.

population. The major identifiable

subgroup with the highest aggregate

exposure is non-nursing infants (<1 year

old) discussed below. EPA generally has

no concern for exposures below 100%

of the RfD because the RfD represents

the level at or below which daily

aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to maneb in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result from aggregate exposure to maneb

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.

The MOE for the U.S. population

exceeds the desired MOE, therefore,

EPA has no short- and intermediateterm aggregate risk concerns.

D. Aggregate Cancer Risk for U.S.

Population

The aggregate dietary cancer risk for

ETU was calculated to be 1.2 x 10-6 for

all the published and pending uses for

maneb including this section 18 use and

for all commodities which contain ETU

as a result of the use of EDBC

compounds. In EPA’s best scientific

judgement, additional potential

exposure from residues in water would

not increase cancer risk estimates above

the Agency’s level 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

maneb, EPA considered data from

developmental toxicity studies in the rat

and a two-generation reproduction

study in the rat. The developmental

toxicity studies are designed to evaluate

adverse effects on the developing

organism resulting from maternal

pesticide exposure during gestation.

Reproduction studies provide

information relating to effects from

exposure to the pesticide on the

reproductive capability of mating

animals and data on systemic toxicity.

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of safety for infants and children in the

case of threshold effects to account for

pre-and post-natal toxicity and the

completeness of the database unless

EPA determines that a different margin

of safety will be safe for infants and

children. Margins of safety are

incorporated into EPA risk assessments

either directly through use of a MOE

analysis or through using uncertainty

(safety) factors in calculating a dose

level that poses no appreciable risk to

humans. EPA believes that reliable data

support using the standard 100-fold

safety factor (usually 100 for combined

inter- and intra-species variability)) and

not the additional tenfold safety factor

when EPA has a complete data base

under existing guidelines and when the

severity of the effect in infants or

children or the potency or unusual toxic

properties of a compound do not raise

concerns regarding the adequacy of the

standard safety factor.

ii. Developmental toxicity studies.

From the rat developmental study for

ETU, the oral developmental NOEL is 5

mg/kg/day, based on a threshold finding

of delayed ossification in the fetal

skeletal structures at the NOEL.

iii. Reproductive toxicity study. There

is no reproduction study with ETU

available. In the rat reproduction study

for maneb, the parental (systemic) NOEL

was 6.0 mg/kg/day, based on decreased

body weight and food consumption at

the LOEL of 25 mg/kg/day. The

developmental (pup) NOEL was 6.0 mg/

kg/day, based on increased startle

response at the LOEL of 25 mg/kg/day.

iv. Pre- and post-natal sensitivity. The

rat developmental study with ETU

demonstrated a special prenatal

sensitivity for infants and children. The

results of the rat reproduction study

with maneb do not demonstrate any

additional special post-natal sensitivity

for infants and children, since the NOEL

and LOEL for parental toxicity and pup

toxicity occur at the same doses and the

pup effects are not of unusual concern.

v. Conclusion. In the absence of a

complete data base for ETU, EPA is

assuming an additional tenfold safety

factor to account for the possibility of

special prenatal sensitivity for infants

and children.

2. Acute risk. The acute dietary risk

assessment for ETU residues

demonstrated an MOE of 5,000 based on

the NOEL of 5 mg/kg/day in the rat

developmental study. Therefore, this

calculated MOE for ETU for females 13+

years of age shows that the MOEs for

this population subgroup are far in

excess of the required dietary MOE of

1,000 due to ETU data gaps. Therefore,

the acute dietary risks for ETU to

females 13+ years of age are below

EPA’s level of concern. The RfD for ETU

incorporates an uncertainty factor of

3,000. The uncertainty factor was based

on a factor of 3 for absence of a NOEL
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49923

for ETU, a factor of 10 for data gaps

needed to assess extra sensitivity to

infants and children for ETU, and the

normal factor of 100 for converting

between and within species (EBDC PD/

4, 3/2/92).

3. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to maneb from

food will utilize 78.4% of the RfD for

non-nursing infants (<1 year old). EPA

generally has no concern for exposures

below 100% of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. Despite the potential

for exposure to maneb in drinking

water, EPA does not expect the

aggregate exposure to exceed 100% of

the RfD. EPA concludes that there is a

reasonable certainty that no harm will

result to infants and children from

aggregate exposure to maneb residues.

4. Short- or intermediate-term risk.

The MOEs for infants and children

exceed the desired MOE, therefore, EPA

has no short- and intermediate-term

aggregate risk concerns.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants is

adequately understood. The residues of

concern are the fungicide maneb,

calculated as zinc

ethylenebisdithiocarbamate, and its

metabolite ethylenethiourea. Secondary

residues are not expected in animal

commodities as no feed items are

associated with this use.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

is available for maneb in the Pesticide

Analytical Manual ( PAM ) II Method

III. Prior to publication in PAM II,

additional enforcement methodology is

available in the interim to anyone who

is interested in pesticide enforcement

when requested from: Calvin Furlow,

Public Response and Program Resource

Branch, Field Operations Division

(7506C), Office of Pesticide Programs,

Environmental Protection Agency, 401

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

Office location and telephone number:

Rm 1128, CM #2, 1921 Jefferson Davis

Hwy., Arlington, VA 22202, 703-305-

5805.

C. Magnitude of Residues

Residues of maneb (manganous

ethylenebisdithiocarbamate) calculated

as zinc ethylenebisdithiocarbamate and

its metabolite ethylenethiourea are not

expected to exceed 0.05 ppm in or on

walnuts as a result of this proposed use.

Secondary residues are not expected in

animal commodities as no feed items

are associated with this use

D. International Residue Limits

No Codex, Canadian or Mexican

maximum residue levels have been

established for residues of maneb in/on

walnuts.

VI. Conclusion

Therefore, the tolerance is established

for residues of maneb (manganous

ethylenebisdithiocarbamate), calculated

as zinc ethylenebisdithiocarbamate, and

its metabolite ethylenethiourea in

walnuts at 0.05 ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

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

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by November 24,

1997, file written objections to any

aspect of this regulation and may also

request a hearing on those objections.

Objections and hearing requests must be

filed with the Hearing Clerk, at the

address given above (40 CFR 178.20). A

copy of the objections and/or hearing

requests filed with the Hearing Clerk

should be submitted to the OPP docket

for this rulemaking. The objections

submitted must specify the provisions

of the regulation deemed objectionable

and the grounds for the objections (40

CFR 178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300545] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7506C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall #2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes a timelimited tolerance under FFDCA section
49924 Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations

408(l)(6). The Office of Management and

Budget (OMB) has exempted these types

of actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

U.S.C. 3501 et seq., or impose any

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

Reform Act of 1995 (UMRA) (Pub. L.

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

FFDCA section 408 (l)(6), such as the

tolerance in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

Flexibility Act (RFA) (5 U.S.C. 601 et

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

actions published on May 4, 1981 (46

FR 24950), and was provided to the

Chief Counsel for Advocacy of the Small

Business Administration.

X. Submission to Congress and the

General Accounting Office

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

by the Small Business Regulatory

Enforcement Fairness Act of 1996, the

Agency has submitted a report

containing this rule and other required

information to the U.S. Senate, the U.S.

House of Representatives, and the

Comptroller General of the General

Accounting Office prior to publication

of this rule in today’s Federal Register.

This is not a ‘‘major rule’’ as defined by

5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: August 29, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. Section 180.110 is revised to read

as follows:

§ 180.110 Maneb; tolerances for residues.

(a) General . Tolerances for residues

of the fungicide maneb (manganous

ethylenebisdithiocarbamate), calculated

as zinc ethylenebisdithiocarbamate, are

established in or on raw agricultural

commodities in the following table:

Commodity Parts per million Expiration/Revocation Date

Almonds ............................................................................................... 0.1 None

Apples .................................................................................................. 2 None

Apricots ................................................................................................ 10 None

Bananas (not more than 0.5 part per million) shall be in the pulp

after peel is removed and discarded (preharvest application only).

4 None

Beans (dry form) .................................................................................. 7 None

Beans (succulent form) ....................................................................... 10 None

Broccoli ................................................................................................ 10 None

Brussels sprouts .................................................................................. 10 None

Cabbage .............................................................................................. 10 None

Carrots ................................................................................................. 7 None

Cauliflower ........................................................................................... 10 None

Celery .................................................................................................. 5 None

Chinese cabbage ................................................................................. 10 None

Collards ................................................................................................ 10 None

Cranberries .......................................................................................... 7 None

Cucumbers .......................................................................................... 4 None

Eggplants ............................................................................................. 7 None

Endive (escarole) ................................................................................. 10 None

Figs ...................................................................................................... 7 None

Grapes ................................................................................................. 7 None

Kale ...................................................................................................... 10 None

Kohlrabi ................................................................................................ 10 None

Lettuce ................................................................................................. 10 None

Melons ................................................................................................. 4 None

Mustard greens .................................................................................... 10 None

Nectarines ............................................................................................ 10 None

Onions ................................................................................................. 7 None

Papayas ............................................................................................... 10 None

Peaches ............................................................................................... 10 None

Peppers ............................................................................................... 7 None

Potatoes ............................................................................................... 0.1 None

Pumpkins ............................................................................................. 7 None

Rhubarb ............................................................................................... 10 None

Spinach ................................................................................................ 10 None

Sugar beet tops ................................................................................... 45 None
Federal Register / Vol. 62, No. 185 /Wednesday, September 24, 1997 /Rules and Regulations 49925

Commodity Parts per million Expiration/Revocation Date

Summer squash .................................................................................. 4 None

Sweet corn (kernels plus cob with husk removed) ............................. 5 None

Tomatoes ............................................................................................. 4 None

Turnip roots ......................................................................................... 7 None

Turnip tops ........................................................................................... 10 None

Winter squash ...................................................................................... 4 None

(b) Section 18 emergency exemptions.

A time-limited tolerance is established

for residues of the fungicide maneb

(manganous

ethylenebisdithiocarbamate), calculated

as zinc ethylenebisdithiocarbamate, and

its metabolite ethylenethiourea in

connection with use of the pesticide

under a section 18 emergency

exemption granted by EPA. The

tolerance will expire and is revoked on

the date specified in the following table:

Commodity Parts per million Expiration/Revocation Date

Walnuts ................................................................................................ 0.05 6/15/98

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–25097 Filed 9-23-97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180 and 185

[OPP–300544; FRL–5740–8]

RIN 2070–AB78

Endothall; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for residues of

endothall in or on canola seed. This

action is in response to EPA’s granting

of an emergency exemption under

section 18 of the Federal Insecticide,

Fungicide, and Rodenticide Act

authorizing use of the pesticide on

canola in Minnesota. This regulation

establishes a maximum permissible

level for residues of endothall 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

August 31, 1998.

DATES: This regulation is effective

September 24, 1997. Objections and

requests for hearings must be received

by EPA on or before November 24, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300544],

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–

300544], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM #2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

objections and hearing requests must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption. Copies of objections and

hearing requests will also be accepted

on disks in WordPerfect 5.1 file format

or ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300544]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Andrea Beard, Registration

Division 7505C, Office of Pesticide

Programs, Environmental Protection

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

DC 20460. Office location, telephone

number, and e-mail address: Crystal

Mall #2, 1921 Jefferson Davis Hwy.,

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

beard.andrea@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

a tolerance for residues of the herbicide

endothall, in or on canola seed at 0.3

part per million (ppm). This tolerance

will expire and is revoked on August 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