65030 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Rules and Regulations

Dated: November 26, 1997.

Felicia Marcus,

Regional Administrator.

Part 81, chapter I, title 40 of the Code

of Federal Regulations is amended as

follows:

PART 81—[AMENDED]

1. The authority citation for part 81

continues to read as follows:

Authority: 42 U.S.C. 7401–7671q.

2. In § 81.305 the table for

California—Ozone, is amended by

revising the entry for ‘‘Santa BarbaraSanta Maria-Lompoc Area Santa Barbara

County’’ to read as follows:

§ 81.305 California.

* * * * *

CALIFORNIA-OZONE

Designated area

Designation Classification

Date 1 Type Date 1 Type

* * * * * * *

Santa Barbara-Santa Maria-Lompoc Area Santa Barbara County ........................... 11/15/90 Nonattainment .... 1–9–98 Serious.

* * * * * * *

1This date is November 15, 1990, unless otherwise noted.

[FR Doc. 97–32332 Filed 12–9–97; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300588; FRL–5758–2]

RIN 2070–AB78

Cyromazine; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for the

combined residues of cyromazine and

its metabolite melamine in or on lima

beans and blackeye peas. 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 lima beans and

blackeye peas. This regulation

establishes a maximum permissible

level for residues of cyromazine in this

food commodity pursuant to section

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

Cosmetic Act, as amended by the Food

Quality Protection Act of 1996. The

tolerance will expire and is revoked on

December 31, 1998.

DATES: This regulation is effective

December 10, 1997. Objections and

requests for hearings must be received

by EPA on or before February 9, 1998.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300588],

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–

300588], must also be submitted to:

Public Information and Records

Integrity Branch, Information Resources

and Services Division (7502C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person, bring

a copy of objections and hearing

requests to Rm. 1132, CM 2, 1921

Jefferson Davis Hwy., Arlington, VA.

A copy of objections and hearing

requests filed with the Hearing Clerk

may also be submitted electronically by

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

Copies of objections and hearing

requests must be submitted as an ASCII

file avoiding the use of special

characters and any form of encryption.

Copies of objections and hearing

requests will also be accepted on disks

in WordPerfect 5.1/6.1 file format or

ASCII file format. All copies of

objections and hearing requests in

electronic form must be identified by

the docket control number [OPP–

300588]. 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: Andrew Ertman, 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) 308–9367, e-mail:

ertman.andrew@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 combined residues of the

insecticide cyromazine and its

metabolite melamine in or on lima

beans at 5.0 part per million (ppm) and

blackeye peas at 5.0 ppm. This tolerance

will expire and is revoked on December

31, 998. EPA will publish a document

in the Federal Register to remove the

revoked tolerance from the Code of

Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

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

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

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

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996) (FRL–5572–9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a
Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Rules and Regulations 65031

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

tolerances to set binding precedents for

the application of section 408 and the

new safety standard to other tolerances

and exemptions.

II. Emergency Exemption for

Cyromazine on Lima Beans and

Blackeye Peas and FFDCA Tolerances

Insect pressure from the leafminer has

increased over the past several years

due to the rapid increase in the insect’s

resistance to currently registered

insecticides and the resulting increase

in insect populations. With the end of

the California drought, over wintering

has occurred in leafminer populations

and mild weather has added to the

resistance population with outbreaks

increasing in the summer and carrying

through the end of the harvest season.

The applicant states that in 1996 some

outbreaks were so severe that several

fields (both lima bean and blackeye pea)

were abandoned rather than harvested.

Current alternatives for use on

blackeye peas have proven ineffective

and there are few registered alternatives

for control of leafminer in lima beans.

EPA has authorized under FIFRA

section 18 the use of cyromazine on

lima beans and blackeye peas for control

of leafminer in California. After having

reviewed these submissions, EPA

concurs that emergency conditions exist

for this state.

As part of its assessment of these

emergency exemptions, EPA assessed

the potential risks presented by residues

of cyromazine in or on lima beans and

blackeye peas. In doing so, EPA

considered the new safety standard in

FFDCA section 408(b)(2), and EPA

decided that the necessary tolerances

under FFDCA section 408(l)(6) would be

consistent with the new safety standard

and with FIFRA section 18. Consistent

with the need to move quickly on the

emergency exemptions in order to

address an urgent non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing these

tolerances without notice and

opportunity for public comment under

section 408(e), as provided in section

408(l)(6). Although these tolerances will

expire and are revoked on December 31,

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

residues of the pesticide not in excess

of the amounts specified in the

tolerances remaining in or on lima

beans and blackeye peas after that date

will not be unlawful, provided the

pesticide is applied in a manner that

was lawful under FIFRA. EPA will take

action to revoke these tolerances earlier

if any experience with, scientific data

on, or other relevant information on this

pesticide indicate that the residues are

not safe.

Because these tolerances are being

approved under emergency conditions

EPA has not made any decisions about

whether cyromazine meets EPA’s

registration requirements for use on

lima beans and blackeye peas or

whether permanent tolerances for these

uses would be appropriate. Under these

circumstances, EPA does not believe

that these tolerances serve as a basis for

registration of cyromazine by a State for

special local needs under FIFRA section

24(c). Nor do these tolerances serve as

the basis for any State other than

California to use this pesticide on these

crops under section 18 of FIFRA

without following all provisions of

section 18 as identified in 40 CFR part

166. For additional information

regarding the emergency exemptions for

cyromazine, 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 ten

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 ten

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.
65032 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 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 three

sources are not typically added because

of the very low probability of this

occurring in most cases, and because the

other conservative assumptions built

into the assessment assure adequate

protection of public health. However,

for cases in which high-end exposure

can reasonably be expected from

multiple sources (e.g. frequent and

widespread homeowner use in a

specific geographical area), multiple

high-end risks will be aggregated and

presented as part of the comprehensive

risk assessment/characterization. Since

the toxicological endpoint considered in

this assessment reflects exposure over a

period of at least 7 days, an additional

degree of conservatism is built into the

assessment; i.e., the risk assessment

nominally covers 1–7 days exposure,

and the toxicological endpoint/NOEL is

selected to be adequate for at least 7

days of exposure. (Toxicity results at

lower levels when the dosing duration

is increased.)

Intermediate-term risk results from

exposure for 7 days to several months.

This assessment is handled in a manner

similar to the short-term risk

assessment.

Chronic risk assessment describes risk

which could result from several months

to a lifetime of exposure. For this

assessment, risks are aggregated

considering average exposure from all

sources for representative population

subgroups including infants and

children.

B. Aggregate Exposure

In examining aggregate exposure,

FFDCA section 408 requires that EPA

take into account available and reliable

information concerning exposure from

the pesticide residue in the food in

question, residues in other foods for

which there are tolerances, residues in

ground water or surface water that is

consumed as drinking water, and other

non-occupational exposures through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses). Dietary exposure to residues of a

pesticide in a food commodity are

estimated by multiplying the average

daily consumption of the food forms of

that commodity by the tolerance level or

the anticipated pesticide residue level.

The Theoretical Maximum Residue

Contribution (TMRC) is an estimate of

the level of residues consumed daily if

each food item contained pesticide

residues equal to the tolerance. In

evaluating food exposures, EPA takes

into account varying consumption

patterns of major identifiable subgroups

of consumers, including infants and

children.The TMRC is a ‘‘worst case’’

estimate since it is based on the

assumptions that food contains

pesticide residues at the tolerance level

and that 100% of the crop is treated by

pesticides that have established

tolerances. If the TMRC exceeds the RfD

or poses a lifetime cancer risk that is

greater than approximately one in a

million, EPA attempts to derive a more

accurate exposure estimate for the

pesticide by evaluating additional types

of information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

Percent of crop treated estimates are

derived from Federal and private market

survey data. Typically, a range of

estimates are supplied and the upper

end of this range is assumed for the

exposure assessment. By using this

upper end estimate of percent of crop

treated, the Agency is reasonably certain

that exposure is not understated for any

significant subpopulation group.

Further, regional consumption

information is taken into account

through EPA’s computer-based model

for evaluating the exposure of

significant subpopulations including

several regional groups, to pesticide

residues. For this pesticide, the most

highly exposed population subgroup

(children 1–6 years old) was not

regionally based.

IV. Aggregate Risk Assessment and

Determination of Safety

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

EPA has reviewed the available

scientific data and other relevant

information in support of these actions,

EPA has sufficient data to assess the

hazards of cyromazine and to make a

determination on aggregate exposure,

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

time-limited tolerances for the

combined residues of cyromazine and

its metabolite melamine on lima beans

at 5.0 ppm and blackeye peas at 5.0

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 cyromazine are

discussed below.

1. Acute toxicity. An acute dietary risk

endpoint was not identified and an

acute dietary risk assessment is not

required.

2. Short—and intermediate—term

toxicity. For short-term
Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Rules and Regulations 65033

Margin of Exposure (MOE)

calculations, the Agency used a

systemic NOEL of 0.75 milligrams/

kilogram/day (mg/kg/day) from a 6-

month dog feeding study. At the lowest

effect level (LEL) of 7.5 mg/kg/day, there

were changes in hematological

parameters.

3. Chronic toxicity. EPA has

established the RfD for cyromazine at

0.0075 mg/kg/day. This RfD is based on

a 6-month feeding study in the dog with

a NOEL of 0.75 mg/kg/day and a LEL of

7.5 mg/kg/day based on pronounced

effects on hematological parameters and

an uncertainty factor of 100.

4. Carcinogenicity. Cyromazine has

been classified as a Group

E (evidence of non-carcinogenicity for

humans) chemical by the Agency’s

Cancer Peer Review (CPR) Committee.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.414) for the combined

residues of cyromazine, in or on a

variety of raw agricultural commodities

at levels ranging from 1.0 ppm in

tomatoes to 10 ppm in leafy vegetables.

Currently there are tolerances for

residues of cyromazine and its

metabolite melamine on the meat fat

and meat by-products of chickens from

the use of cyromazine as a feed-through.

Risk assessments were conducted by

EPA to assess dietary exposures and

risks from cyromazine 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. An acute

dietary risk endpoint was not identified

and an acute risk assessment is not

required.

ii. Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, EPA has made very

conservative assumptions including

100% of crop treated for lima bean and

blackeyed pea and most other

commodities having cyromazine

tolerances. The Agency used percent

crop treated on such crops as tomatoes,

peppers and lettuce and assumed all

crops will contain cyromazine residues

and those residues would be at the level

of the tolerance. This will result in an

overestimate of human dietary

exposure. Thus, in making a safety

determination for this tolerance, EPA is

taking into account this conservative

exposure assessment.

The existing cyromazine tolerances

(published, pending, and including the

necessary section 18 tolerance(s)) result

in an Anticipated Residue Contribution

(ARC) that is equivalent to the following

percentages of the RfD:

Subgroup Percent

U.S. population (48 States) ...... 34

Nursing infants (<1 year old) .... 12

Non-nursing infants (<1 year

old) ........................................ 53

Children (1–6 years old) ........... 54

Children (7–12 years old) ......... 44

The subgroups listed above are: (1)

the U.S. population (48 states); (2) those

for infants and children; and, (3) the

other subgroups for which the

percentage of the RfD occupied is

greater than that occupied by the

subgroup U.S. population (48 states).

2. From drinking water. Based on

information available to the

Agency, cyromazine is persistent and

relatively mobile. There are no

established Maximum Contaminant

Levels for residues of cyromazine in

drinking water. No health advisory

levels for cyromazine in drinking water

have been established.

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 cyromazine 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

cyromazine 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.

Cyromazine is not registered for use on

residential non-food sites.

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

cyromazine has a common mechanism
65034 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Rules and Regulations

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,

cyromazine 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 cyromazine has a common

mechanism of toxicity with other

substances.

C. Aggregate Risks and Determination of

Safety for U.S. Population

Chronic risk. Using the conservative

ARC exposure assumptions described in

Unit IV.B.1.ii. of this preamble, and

taking into account the completeness

and reliability of the toxicity data, EPA

has calculated that dietary exposure to

cyromazine from food will utilize 34%

of the RfD for the U.S. population. The

Agency 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

cyromazine in drinking water, EPA does

not expect the aggregate exposure to

exceed 100% of the RfD. Under current

Agency guidelines, the registered nondietary uses of cyromazine do not

constitute a chronic exposure scenario.

The Agency concludes that there is a

reasonable certainty that no harm will

result from chronic aggregate exposure

to cyromazine residues.

D. Endocrine Disrupter Effects

EPA is required to develop a

screening program to determine whether

certain substances (including all

pesticides and inerts) ‘‘may have an

effect in humans that is similar to an

effect produced by a naturally occurring

estrogen, or such other endocrine

effect....’’ The Agency is currently

working with interested stakeholders,

including other government agencies,

public interest groups, industry and

research scientists in developing a

screening and testing program and a

priority setting scheme to implement

this program.

Congress has allowed 3 years from the

passage of FQPA (August 3, 1999) to

implement this program. At that time,

EPA may require further testing of this

active ingredient and end use products

for endocrine disrupter effects.

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

cyromazine, 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

pesticide exposure during prenatal

development to one or both parents.

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 MOE and

uncertainty factor (usually 100 for

combined inter-and intra-species

variability) and not the additional

tenfold MOE/uncertainty 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 MOE/safety factor.

ii. Developmental toxicity studies.

From the rat developmental study, the

maternal (systemic) NOEL was 100 mg/

kg/day, based on increased incidence of

clinical signs and decreased body

weight at the lowest observed effect

level (LOEL) of 300 mg/kg/day. The

developmental (pup) NOEL was 300

mg/kg/day, based on increased

incidence of skeletal variations at the

LOEL of 600 mg/kg/day.

From the rabbit developmental study,

the maternal (systemic) NOEL was 10

mg/kg/day, based on decreased weight

gain and food consumption at the LOEL

of 30 mg/kg/day. The developmental

(pup) NOEL was 60 mg/kg/day, the

highest dose tested (HDT).

iii. Reproductive toxicity study. From

the rat reproduction study, the maternal

(systemic) NOEL was 50 mg/kg/day,

based on body weight loss at the LOEL

of 150 mg/kg/day. The reproductive/

developmental (pup) NOEL was 50 mg/

kg/day, based on decreased pup growth,

decreased number of pups per litter, and

increased fetotoxicity at the LEL of 150

mg/kg/day.

iv. Pre-and post-natal sensitivity. The

toxicological data base for evaluating

pre-and post-natal toxicity for

cyromazine is complete with respect to

current data requirements. There are no

pre-or post-natal toxicity concerns for

infants and children, based on the

results of the rat and rabbit

developmental toxicity studies and the

2-generation rat reproductive toxicity

study.

v. Conclusion. The Agency concludes

that reliable data support use of the

standard 100-fold margin of exposure/

uncertainty factor and that an additional

margin/factor is not needed to protect

infants and children.

2. Chronic risk. Using the

conservative exposure assumptions

described in Unit IV.B.1.ii. of this

preamble, EPA has concluded that the

percentage of the RfD that will be

utilized by dietary (food) exposure to

residues of cyromazine ranges from 53%

for non-nursing infants less than one

year old, up to 54% for children 1–6

years old. EPA generally has no concern

for exposures below 100% of the RfD

because the RfD represents the level at

or below which daily aggregate dietary

exposure over a lifetime will not pose

appreciable risks to human health.

Despite the potential for exposure to

cyromazine in drinking water and from

non-dietary, non-occupational exposure,

EPA does not expect the aggregate

exposure to exceed 100% of the RfD.

EPA concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to cyromazine residues.

V. Other Considerations

A. Metabolism In Plants and Animals

The nature of the residue in plants

and animals is adequately understood.

The residue of concern is parent

cyromazine and the metabolite

melamine as specified in 40 CFR

180.414.

B. Analytical Enforcement Methodology

Adequate enforcement methodology

for crops (HPLC with UV detector) is

available in PAM II to enforce the

tolerance expression.

C. Magnitude of Residues

Residues of cyromazine and its

metabolite melamine are not expected to

exceed 5.0 ppm in/on either lima beans

or blackeyed peas as a result of this

section 18 use. Secondary residues in

animal commodities are not expected to

exceed existing tolerances as a result of

this section 18 use.
Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Rules and Regulations 65035

D. International Residue Limits

There are no CODEX, Canadian, or

Mexican MRL’s for cyromazine on lima

beans or blackeyed peas.

E. Rotational Crop Restrictions

Crops with permitted uses on the

federal label may be planted as

rotational crops, additionally sweet corn

and radishes may be planted as

rotational crops 3 months after the last

application to beans.

VI. Conclusion

Therefore, the tolerance is established

for combined residues of cyromazine in

lima beans at 5.0 ppm and blackeye

peas at 5.0 ppm.

VII. Objections and Hearing Requests

The new FFDCA section 408(g)

provides essentially the same process

for persons to ‘‘object’’ to a tolerance

regulation issued by EPA under new

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

in the old section 408 and in section

409. However, the period for filing

objections is 60 days, rather than 30

days. EPA currently has procedural

regulations which govern the

submission of objections and hearing

requests. These regulations will require

some modification to reflect the new

law. However, until those modifications

can be made, EPA will continue to use

those procedural regulations with

appropriate adjustments to reflect the

new law.

Any person may, by February 9, 1998,

file written objections to any aspect of

this regulation and may also request a

hearing on those objections. Objections

and hearing requests must be filed with

the Hearing Clerk, at the address given

above (40 CFR 178.20). A copy of the

objections and/or hearing requests filed

with the Hearing Clerk should be

submitted to the OPP docket for this

rulemaking. The objections submitted

must specify the provisions of the

regulation deemed objectionable and the

grounds for the objections (40 CFR

178.25). Each objection must be

accompanied by the fee prescribed by

40 CFR 180.33(i). If a hearing is

requested, the objections must include a

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

CBI. Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket control

number [OPP–300588] (including any

comments and data submitted

electronically). A public version of this

record, including printed, paper

versions of electronic comments, which

does not include any information

claimed as CBI, is available for

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

Monday through Friday, excluding legal

holidays. The public record is located in

Room 1132 of the Public Information

and Records Integrity Branch,

Information Resources and Services

Division (7502C), Office of Pesticide

Programs, Environmental Protection

Agency, Crystal Mall 2, 1921 Jefferson

Davis Hwy., Arlington, VA.

Electronic comments may be sent

directly to EPA at:

opp-docket@epamail.epa.gov.

Electronic comments must be

submitted as an ASCII file avoiding the

use of special characters and any form

of encryption.

The official record for this

rulemaking, as well as the public

version, as described above will be kept

in paper form. Accordingly, EPA will

transfer any copies of objections and

hearing requests received electronically

into printed, paper form as they are

received and will place the paper copies

in the official rulemaking record which

will also include all comments

submitted directly in writing. The

official rulemaking record is the paper

record maintained at the Virginia

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

This final rule establishes tolerances

under FFDCA section 408(l)(6). The

Office of Management and Budget

(OMB) has exempted these types of

actions from review under Executive

Order 12866, entitled Regulatory

Planning and Review (58 FR 51735,

October 4, 1993). This final rule does

not contain any information collections

subject to OMB approval under the

Paperwork Reduction Act (PRA), 44

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

enforceable duty or contain any

unfunded mandate as described under

Title II of the Unfunded Mandates

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

104–4). Nor does it require any prior

consultation as specified by Executive

Order 12875, entitled Enhancing the

Intergovernmental Partnership (58 FR

58093, October 28, 1993), or special

considerations as required by Executive

Order 12898, entitled Federal Actions to

Address Environmental Justice in

Minority Populations and Low-Income

Populations (59 FR 7629, February 16,

1994), or require OMB review in

accordance with Executive Order 13045,

entitled Protection of Children from

Environmental Health Risks and Safety

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

In addition, since these tolerances and

exemptions that are established under

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

tolerances in this final rule, do not

require the issuance of a proposed rule,

the requirements of the Regulatory

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

seq.) do not apply. Nevertheless, the

Agency has previously assessed whether

establishing tolerances, exemptions

from tolerances, raising tolerance levels

or expanding exemptions might

adversely impact small entities and

concluded, as a generic matter, that

there is no adverse economic impact.

The factual basis for the Agency’s

generic certification for tolerance

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).
65036 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Rules and Regulations

1We calculate that March 20, 1998 reflects the

earliest date on which the Administrator will

distribute funds under these programs, by starting

with November 24, 1997 and adding to it a 75-day

List of Subjects in 40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: November 25, 1997.

Peter Caulkins,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.414, in paragraph (b) by

alphabetically adding the following

commodities to the table to read as

follows:

§ 180.414 Cyromazine; tolerances for

residues.

* * * * *

(b) * * *

Commodity Parts per million Expiration/revocation date

Beans, lima .............................................. 5.0 12/31/98

* * * * * * *

Peas, blackeyed ....................................... 5.0 12/31/98

* * * * * * *

* * * * *

[FR Doc. 97–32039 Filed 12–9–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 54

[CC Docket No. 96–45, CC 97–21; FCC 97–

400]

Universal Service Support

Mechanisms

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: The Commission authorized

the Administrator of the universal

service support mechanisms to require

payment of quarterly contributions to

universal service in equal monthly

installments. Allowing monthly

payments will reduce the cash flow

impact on contributors because their

payments will be smaller. It also will

better enable contributors to offset their

contributions by payments from the

support mechanisms. It will not

jeopardize the sufficiency of the support

mechanisms.

EFFECTIVE DATE: January 9, 1998.

FOR FURTHER INFORMATION CONTACT:

Diane Law, (202) 418–7400.

SUPPLEMENTARY INFORMATION:

SECOND ORDER ON RECONSIDERATION in

CC Docket No. 97–21

I. Background

1. In the Universal Service Order, the

Commission created new federal

universal service support mechanisms

and concluded that all

telecommunications carriers that

provide interstate telecommunications

services, other providers of interstate

telecommunications, and payphone

service providers will contribute to

universal service. (See Federal-State

Joint Board on Universal Service, Report

and Order, CC Docket No. 96–45, FCC

97–157, 62 FR 32862 (June 17, 1997)).

In the NECA Report and Order, the

Commission instructed the National

Exchange Carrier Association (NECA) to

create an independent subsidiary, the

Universal Service Administrative

Company (USAC or Administrator), to

administer temporarily portions of the

universal service support mechanisms.

(See Changes to the Board of Directors

of the National Exchange Carriers

Association, Inc., Federal-State Joint

Board on Universal Service, Report and

Order and Second Order on

Reconsideration, CC Docket No. 97–21,

CC Docket No. 96–45, FCC 97–253, 62

FR 41294 (August 1, 1997)). The

Commission also instructed the

Administrator to bill contributors and

collect contributions to the federal

universal service support mechanisms

on a quarterly basis.

2. USAC requests that it be authorized

to collect universal service

contributions on a monthly, as opposed

to a quarterly, basis. USAC states that

collecting contributions on a quarterly

basis may create significant cash flow

problems for contributors. USAC

explains that, because of the delay

between funds collection and funds

distribution, monthly billing will not

increase the likelihood that the

Administrator will be required to

borrow money to fund early requests for

discounts by eligible schools and

libraries. In addition, USAC notes that

collecting contributions on a monthly

basis will generate some interest

income, albeit less than would be

collected on a quarterly basis, that can

be applied to meet program demands.

NECA supports USAC’s request.

II. Discussion

3. Based on the Administrator’s

request, we reconsider, on our own

motion, our requirement that the

Administrator collect contributions on a

quarterly basis. Allowing monthly

payments would reduce the cash flow

impact on contributors because their

payments would be smaller. It also

would better enable contributors to

offset their contributions by payments

from the support mechanisms. We

conclude that permitting monthly as

opposed to quarterly contributions will

not jeopardize the sufficiency of the

support mechanisms. The Commission

reduced the estimated total contribution

base by two percent when calculating

the universal service contribution

factors to take account of the possibility

that contributions to the support

mechanisms may fall short of estimated

levels due to, for example,

uncollectibles or higher-than-foreseen

demand. In addition, since March 20,

1998 appears to be the earliest date on

which the Administrator could be

required to make distributions under the

schools, libraries, and rural health care

programs,1 we anticipate that, under our