55784 Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations

will not be considered to be actionable

if the herbicide is applied during the

term of and in accordance with the

provisions of paragraph (a) of this

section.

Commodity Parts per

million

Expiration/

revocation

date

Cottonseed ......... 0.02 Sept. 30,

1999

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registrations. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

[FR Doc. 97–27843 Filed 10–21–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180 and 186

[OPP–300563; FRL–5748–9]

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 the

meat, fat, and meat byproducts of

turkeys. 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 turkeys. This regulation

establishes a maximum permissible

level for residues of cyromazine and its

metabolite melamine 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. These tolerances

will expire and are revoked on October

1, 1998.

DATES: This regulation is effective

October 22, 1997. Objections and

requests for hearings must be received

by EPA on or before December 22, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300563],

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–

300563], 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–

300563]. 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

tolerances for combined residues of the

insecticide (larvicide) cyromazine and

its metabolite melamine, in or on meat,

fat, and meat byproducts of turkeys at

0.05 part per million (ppm). These

tolerances will expire and are revoked

on October 1, 1998. EPA will publish a

document in the Federal Register to

remove the revoked tolerances from the

Code of Federal Regulations.

I. Background and Statutory Authority

The Food Quality Protection Act of

1996 (FQPA) (Pub. L. 104–170) was

signed into law August 3, 1996. FQPA

amends both the Federal Food, Drug,

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

301 et seq., and the Federal Insecticide,

Fungicide, and Rodenticide Act

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

amendments went into effect

immediately. Among other things,

FQPA amends FFDCA to bring all EPA

pesticide tolerance-setting activities

under a new section 408 with a new

safety standard and new procedures.

These activities are described below and

discussed in greater detail in the final

rule establishing the time-limited

tolerance associated with the emergency

exemption for use of propiconazole on

sorghum (61 FR 58135, November 13,

1996)(FRL–5572–9).

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

FFDCA allows EPA to establish a

tolerance (the legal limit for a pesticide

chemical residue in or on a food) only

if EPA determines that the tolerance is

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

‘‘safe’’ to mean that ‘‘there is a

reasonable certainty that no harm will

result from aggregate exposure to the

pesticide chemical residue, including

all anticipated dietary exposures and all

other exposures for which there is

reliable information.’’ This includes

exposure through drinking water and in

residential settings, but does not include

occupational exposure. Section

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

consideration to exposure of infants and

children to the pesticide chemical

residue in establishing a tolerance and

to ‘‘ensure that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to the pesticide chemical

residue. . . .’’

Section 18 of FIFRA authorizes EPA

to exempt any Federal or State agency

from any provision of FIFRA, if EPA

determines that ‘‘emergency conditions

exist which require such exemption.’’

This provision was not amended by

FQPA. EPA has established regulations

governing such emergency exemptions

in 40 CFR part 166.

Section 408(l)(6) of the FFDCA

requires EPA to establish a time-limited

tolerance or exemption from the

requirement for a tolerance for pesticide

chemical residues in food that will

result from the use of a pesticide under

an emergency exemption granted by

EPA under section 18 of FIFRA. Such

tolerances can be established without

providing notice or period for public

comment.
Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations 55785

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

Cyromazine on Turkeys and FFDCA

Tolerances

The applicant has requested an

emergency exemption for the use of

cyromazine on turkeys to control flies.

The applicant states that the flies are

thought to carry spiking mortality, an

acute form of Poult Enteritis Mortality

Syndrome (PEMS). PEMS first appeared

in Union County, North Carolina in

1991. Initially, the disease affected

turkey flocks only in western North

Carolina until it spread to eastern North

Carolina and neighboring states in 1994.

Since that time, it has devastated the

relatively small turkey industry in

Georgia, and has had significant impact

on turkey production in North Carolina.

Estimates are that the disease was

responsible for about $55 million in

losses to the turkey industry in 1996.

Most of these losses were incurred by

North Carolina.

Evidence suggests that house fly

(Musca domestica) can transmit the

PEMS disease agent(s). The applicant

states that the alternative products

available for use on house flies in

poultry houses, tetrachlorvinphos,

dichlorvos, and dimethoate, are applied

as larvicides to the manure accumulated

beneath cages or slatted floors. These

products were developed for use under

caged layers or in chicken houses with

slatted floors; however, market turkeys

are grown in open-floor environments,

and the birds cannot be easily moved

from areas needing treatment. One

problem with this type of treatment of

turkey houses is that rates for larvicidal

use of these chemicals are generally the

highest rates permitted by the label,

creating a concern for the exposed birds.

A second problem with these

alternatives is that the residual control

is 10 to 14 days at best, thus requiring

at least two treatments over the course

of a brooder house flock cycle.

Additionally, it may not be possible to

penetrate the breeding substrate with a

low pressure sprayer as recommended,

due to compaction of the litter. Finally,

these alternatives are labeled as

adulticides, leaving a question of

possible resistance development by

house flies to these chemicals. EPA has

authorized under FIFRA section 18 the

use of cyromazine on turkeys for control

of flies in North Carolina. 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

cyromazine in or on the meat, fat, and

meat byproducts of turkeys. In doing so,

EPA considered the new safety standard

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

decided that the necessary tolerances

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

consistent with the new safety standard

and with FIFRA section 18. Consistent

with the need to move quickly on the

emergency exemption in order to

address an urgent non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing these

tolerances without notice and

opportunity for public comment under

section 408(e), as provided in section

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

expire and are revoked on October 1,

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 meat, fat,

and meat byproducts of turkeys 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

turkeys or whether permanent

tolerances for this use 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 North

Carolina 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 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 10

times more sensitive to pesticides than

the test animals, and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA. EPA generally uses

the RfD to evaluate the chronic risks

posed by pesticide exposure. For shorter

term risks, EPA calculates a margin of

exposure (MOE) by dividing the

estimated human exposure into the

NOEL from the appropriate animal

study. Commonly, EPA finds MOEs

lower than 100 to be unacceptable. This

100-fold MOE is based on the same

rationale as the 100-fold uncertainty

factor.

Lifetime feeding studies in two

species of laboratory animals are

conducted to screen pesticides for

cancer effects. When evidence of

increased cancer is noted in these

studies, the Agency conducts a weight

of the evidence review of all relevant

toxicological data including short-term
55786 Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations

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 subgroups

(non-nursing infants <1 year old and

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 this action,

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 in or on meat,

fat, and meat byproducts of turkeys at

0.05 ppm. EPA’s assessment of the

dietary exposures and risks associated

with establishing these tolerances

follows.

A. Toxicological Profile

EPA has evaluated the available

toxicity data and considered its validity,

completeness, and reliability as well as

the relationship of the results of the

studies to human risk. EPA has also

considered available information

concerning the variability of the

sensitivities of major identifiable

subgroups of consumers, including

infants and children. The nature of the

toxic effects caused by 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 Margin of

Exposure (MOE) calculations, the

Agency is using a systemic NOEL of

0.75 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.
Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations 55787

3. Chronic toxicity. EPA has

established the RfD for cyromazine at

0.0075 milligrams/kilogram/day (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.

B. Exposures and Risks

1. From food and feed uses.

Tolerances have been established (40

CFR 180.414) for the combined residues

of cyromazine and its metabolite

melamine, 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:

Chronic exposure and risk. In

conducting this chronic dietary risk

assessment, the Agency has made very

conservative assumptions which result

in an overestimate of human dietary

exposure:

(1) 100% crop treated is assumed for

all commodities with the exception of

tomatoes, sweet peppers, celery, and

lettuce, where percent crop treated is

used.

(2) All commodities having

cyromazine tolerances are assumed to

contain cyromazine residues and those

residues will be at the level of the

established tolerance.

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 ................................... 32

Nursing Infants .................................... 12

Non-Nursing Infants (<1 year old) ...... 50

Children (1-6 years old) ...................... 50

Children (7-12 years old) .................... 41

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 Level 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 tolerances 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 tolerances are granted.

3. From non-dietary exposure.

Cyromazine is not currently 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

of toxicity with other substances or how

to include this pesticide in a cumulative

risk assessment. For the purposes of

these tolerance actions, therefore, EPA

has not assumed that cyromazine or its

metabolite melamine have common

mechanisms 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

above, and taking into account the

completeness and reliability of the
55788 Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations

toxicity data, EPA has concluded that

aggregate exposure to cyromazine from

food will utilize 32% 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. Since there are no residential

uses, EPA concludes that there is a

reasonable certainty that no harm will

result from chronic aggregate exposure

to cyromazine residues.

D. Aggregate Cancer Risk for U.S.

Population

Cyromazine has been classified as a

Group E (evidence of noncarcinogenicity for humans) chemical

by the Agency.

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 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. Based on the above, EPA

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.

v. Conclusion. Aggregate exposure to

cyromazine does not pose a risk to

infants and children that exceeds the

Agency’s level of concern.

2. Chronic risk. Using the

conservative exposure assumptions

described above, EPA has concluded

that aggregate exposure to cyromazine

from food ranges from 12% for nonnursing infants less than one year old,

up to 50% 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 the published tolerance for chickens

(HPLC with UV detector) is available in

PAM II to enforce the tolerance

expression. This method is adequate for

turkeys.

C. Magnitude of Residues

Residues of Cyromazine and

melamine are not expected to exceed

0.05 ppm in/on turkey meat, fat and

meat byproducts as a result of this

Section 18 use.

D. International Residue Limits

There is a CODEX MRL for residues

of cyromazine per se on poultry meat at

0.05 ppm.

E. Rotational Crop Restrictions

While there are no crop rotation

restrictions on the label of this feed

through product, manure from treated

animals may be used as a soil fertilizer

supplement. There are restrictions on

the amount of manure that may be used

per acre and manure is not to be used

on small grains.

VI. Conclusion

Therefore, tolerances are established

for combined residues of cyromazine

and its metabolite melamine in or on

meat, fat and meat byproducts of

turkeys 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
Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations 55789

appropriate adjustments to reflect the

new law.

Any person may, by December 22,

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

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–300563] (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 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 the 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).

List of Subjects

40 CFR Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

40 CFR Part 186

Environmental protection, Animal

feeds, Pesticides and pests.

Dated: October 6, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Therefore, 40 CFR chapter I is

amended as follows:

PART 180—[AMENDED]

1. In part 180:

a. The authority citation for part 180

continues to read as follows:

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

b. In § 180.414:

i. By adding paragraph (a)(4).

ii. In paragraph (b), by alphabetically

adding the following commodities to the

table.

The addition and amendment to

§ 180.414 read as follows:

§ 180.414 Cyromazine; tolerances for

residues.

(a) * * *

(4) The additive cyromazine (Ncyclopropyl-1,3,5-triazine-2,4,6-

triamine) may be safely used in
55790 Federal Register / Vol. 62, No. 204 / Wednesday, October 22, 1997 / Rules and Regulations

accordance with the following

prescribed conditions:

(i) It is used as a feed additive only

in the feed for chicken layer hens and

chicken breeder hens at the rate of not

more than 0.01 pound of cyromazine

per ton of poultry feed.

(ii) It is used for control of flies in

manure of treated chicken layer hens

and chicken breeder hens.

(iii) Feeding of cyromazine-treated

feed must stop at least 3 days (72 hours)

before slaughter. If the feed is

formulated by any person other than the

end user, the formulator must inform

the end user, in writing, of the 3-day (72

hours) preslaughter interval.

(iv) To ensure safe use of the additive,

the labeling of the pesticide formulation

containing the feed additive shall

conform to the labeling which is

registered by the U.S. Environmental

Protection Agency, and the additive

shall be used in accordance with this

registered labeling.

(v) Residues of cyromazine are not to

exceed 5.0 parts per million (ppm) in

poultry feed.

(b) * * *

Commodity Parts per million Expiration/revocation date

* * * * * * *

Turkey, fat ............................................................................................ 0.05 10/1/98

Turkey, mbyp ....................................................................................... 0.05 10/1/98

Turkey, meat ........................................................................................ 0.05 10/1/98

* * * * *

PART 186—[AMENDED]

2. In part 186:

a. The authority citation for part 186

continues to read as follows:

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

§ 186.1400 [Removed]

b. Section 186.1400 is removed.

[FR Doc. 97–27844 Filed 10–21–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR PART 68

[CC Docket Nos. 96–128 and 91–35; DA 97–

1793]

Pay Telephone Equipment

Grandfathering

AGENCY: Federal Communications

Commission.

ACTION: Final rules; correction.

SUMMARY: The Federal Communications

Commission issues a correction to the

previously published final rule in 62 FR

47371, September 9, 1997, concerning

the connection of terminal equipment to

the telephone network. The rule allows

certain terminal equipment presently

connected to central-office-implemented

payphones to remain connected without

registration. This correction is issued to

clarify that the rule applies to the

‘‘central-office-implemented telephone

line’’ rather than the ‘‘central-officeimplemented telephone.’’ The

correction is intended clarify the

distinction between terminal equipment

and a central-office-implemented

telephone line.

EFFECTIVE DATE: October 5, 1997.

FOR FURTHER INFORMATION CONTACT:

Technical Information: William Von

Alven, 202–418–2342.

Legal Information: Alan Thomas, 202–

418–2338.

SUPPLEMENTARY INFORMATION: Section

68.2(l) (1) and (2) are corrected. 68.2(1)

is corrected by inserting the word ‘‘line’’

after the phrase ‘‘central-officeimplemented telephone’’ in the first

sentence. Section 68.2(l)(2) is corrected

by inserting the word ‘‘line’’ after the

phrase ‘‘central-office-implemented

telephone’’ in the first and second

sentences.

List of Subjects in 47 CFR Part 68

Communications common carriers,

Communications equipment, Reporting

and recordkeeping requirements.

Federal Communications Commission.

LaVera F. Marshall,

Acting Secretary.

Correction

For the reasons discussed in

Supplementary Information make the

following corrections.

§ 68.2 [Corrected]

1. On page 47371, in the third

column, in § 68.2, in paragraph (l)(1), in

lines 3 and 4, the phrase ‘‘central-officeimplemented telephone’’ is corrected to

read ‘‘central-office-implemented

telephone line.’’

2. On page 47371, in the third

column, in § 68.2, in paragraph (l)(2), in

lines 4 and 5 and lines 8 and 9, the

phrase ‘‘central-office-implemented

telephone’’ is corrected to read ‘‘centraloffice-implemented telephone line.’’

[FR Doc. 97–27635 Filed 10–17–97; 8:45 am]

BILLING CODE 6712–01–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 97–148; RM–9088]

Radio Broadcasting Services; New

London, IA

AGENCY: Federal Communications

Commission.

ACTION: Final rule.

SUMMARY: The Commission, at the

request of Sound In Spirit Broadcasting,

Inc., allots Channel 247A at New

London, Iowa, as the community’s first

local aural transmission service.

Channel 247A can be allotted to New

London in compliance with the

Commission’s minimum distance

separation requirements with a site

restriction of 2.7 kilometers (1.7 miles)

west in order to avoid a short-spacing

conflict with the licensed operation of

Station WFYR-FM, Channel 247B1,

Elmwood, Illinois. The coordinates for

Channel 247A at New London are 40–

55–30 NL and 91–25–40 WL. With this

action, this proceeding is terminated.

DATES: Effective: November 24, 1997.

The window period for filing

applications for Channel 247A at New

London, Iowa, will open on November

24, 1997, and close on December 26,

1997.

FOR FURTHER INFORMATION CONTACT: Pam

Blumenthal, Mass Media Bureau, (202)

418–2180.

SUPPLEMENTARY INFORMATION: This is a

synopsis of the Commission’s Report

and Order, MM Docket No. 97–148,

adopted September 24, 1997, and

released October 10, 1997. The full text

of this Commission decision is available

for inspection and copying during

normal business hours in the FCC