17742 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

Commodity Parts per

million Expiration/Revocation Date

Sheep, fat ........................................................................................................................................... 0.2 None

Sheep, mbyp ...................................................................................................................................... 0.2 None

Sheep, meat ....................................................................................................................................... 0.2 None

Soybean, hay ..................................................................................................................................... 10.0 None

Soybeans ........................................................................................................................................... 10.0 None

Spearmint, tops (stems and leaves) .................................................................................................. 30.0 December 31, 1998

Spinach .............................................................................................................................................. 4.0 None

Strawberries ....................................................................................................................................... 10.0 None

Sugar beet molasses ......................................................................................................................... 10.0 None

Sugar beet, roots ............................................................................................................................... 1.0 None

Sugar beet, tops ................................................................................................................................. 3.0 None

Sunflower meal .................................................................................................................................. 20.0 None

Sunflower seeds ................................................................................................................................. 7.0 None

Sweet potato ...................................................................................................................................... 4.0 None

Tomato pomace, dried ....................................................................................................................... 12.0 None

Tomato products, concentrated ......................................................................................................... 24 None

Tree nuts ............................................................................................................................................ 0.2 None

(b) Section 18 emergency exemptions.

[Reserved]

(c) Tolerances with regional

registration. Tolerances with regional

registration, as defined in § 180.1(n), are

established for the combined residues of

the herbicide 2-[1-(ethoxyimino)butyl]-

5-[2-(ethylthio)propyl]-3-hydroxy-2-

cyclohexen-1-one) and its metabolites

containing the 2-cyclohexen-1-one

moiety (calculated as the herbicide) in

or on the following commodities:

Commodity Parts per

million Expiration/Revocation Date

Artichokes ........................................................................................................................................... 3.0 None

Endive ................................................................................................................................................ 2.0 December 31, 1998

Rhubarb .............................................................................................................................................. 0.3 None

(d) Indirect and inadvertent

residues.[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.2800 [Removed]

b. Section 185.2800 is removed.

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

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

§ 186.2800 [Removed]

b. Section 186.2800 is removed.

[FR Doc. 97–9374 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 180, 185, and 186

[OPP–300470; FRL–5598–2]

RIN 2070–AC78

Norflurazon; Pesticide Tolerance for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

the herbicide norflurazon in or on the

raw agricultural commodities

bermudagrass hay and forage in

connection with EPA’s granting of

emergency exemptions under section 18

of the Federal Insecticide, Fungicide,

and Rodenticide Act authorizing use of

norflurazon on bermudagrass in the

states of Alabama, Georgia, Louisiana,

Mississippi, and Texas. This regulation

establishes maximum permissible levels

for residues of norflurazon in these

foods 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 tolerances

will expire and be revoked by EPA on

November 30, 1998.

DATES: This regulation becomes

effective April 11, 1997. Objections and

requests for hearings must be received

by EPA on or before June 10, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300470],

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 document control number, [OPP–

300470], must also be submitted to:

Public Response and Program Resources

Branch, Field Operations 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,
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17743

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–

300470]. No Confidential Business

Information (CBI) should be submitted

through e-mail. Electronic copies of

objections and hearing requests on this

rule may be filed online at many Federal

Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By

mail: Libby Pemberton, Registration

Division (7505W), Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Sixth Floor, Crystal Station #1, 2800

Jefferson Davis Highway, Arlington, VA

22202, (703) 308-8326, e-mail:

pemberton.libby@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

tolerances for residues of norflurazon on

bermudagrass forage at 2 ppm and

bermudagrass hay at 3 ppm. These

tolerances will expire on November 30,

1998.

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) 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, 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.

Section 408(l)(6) also requires EPA to

promulgate regulations by August 3,

1997, governing the establishment of

tolerances and exemptions under

section 408(l)(6) and requires that the

regulations be consistent with section

408(b)(2) and (c)(2) and FIFRA section

18.

Section 408(l)(6) allows EPA to

establish tolerances or exemptions from

the requirement for a tolerance, in

connection with EPA’s granting of

FIFRA section 18 emergency

exemptions, without providing notice or

a period for public comment. Thus,

consistent with the need to act

expeditiously on requests for emergency

exemptions under FIFRA, EPA can

establish such tolerances or exemptions

under the authority of section 408(e)

and (l)(6) without notice and comment

rulemaking.

In establishing section 18-related

tolerances and exemptions during this

interim period before EPA issues the

section 408(l)(6) procedural regulation

and before EPA makes its broad policy

decisions concerning the interpretation

and implementation of the new section

408, EPA does not intend to set

precedents for the application of section

408 and the new safety standard to other

tolerances and exemptions. Rather,

these early section 18 tolerance and

exemption decisions will be made on a

case-by-case basis and will not bind

EPA as it proceeds with further

rulemaking and policy development.

EPA intends to act on section 18-related

tolerances and exemptions that clearly

qualify under the new law.

II. Emergency Exemptions for

Norflurazon on Bermudagrass and

FFDCA Tolerances

EPA has authorized use under FIFRA

section 18 of norflurazon on

bermudagrass hay meadows and patures

for control of grassy weeds.

Bermudagrass requires at least 2 years to

completely cover a planted area and

successfully compete with annual

grassy weeds. Successful establishment

during the first 2 years is critically

important to profitable production from

a bermudagrass hay meadow. Annual

grassy weed encroachment and resulting

variable bermudagrass stands will

reduce the quantity of hay produced

and the overall quality. A hay field does

not reach maximum hay production for

3 or 4 years after establishment

depending on the degree of success in

establishment. For the next 6 to 7 years,

growers should receive maximum

economic yield and return on their

annual investments. The market will not

accept bermudagrass hay contaminated

with weeds or annual grasses.

Bermudagrass stands often begin to

decline after about 10 years due to

diseases, insect problems, fertility

imbalances, or environmental stresses.

Establishment of a new stand of

bermudagrass is the most cost effective

way of maintaining maximum quality

and quantity of hay. Atrazine and

simazine, which traditionally provided

control of these weeds, were voluntarily

canceled in 1990 resulting in this

urgent, nonroutine situation. After

having reviewed their submissions, EPA

concurs that emergency conditions

exist.

As part of its assessment of these

specific exemptions, EPA assessed the

potential risks presented by residues of

norflurazon on bermudagrass hay and

forage. 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 clearly be

consistent with the new safety standard

and with FIFRA section 18. These

tolerances for residues of norflurazon

will permit the marketing of

bermudagrass hay and forage treated in

accordance with the provisions of the

section 18 emergency exemptions.
17744 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

Consistent with the need to move

quickly on these emergency exemptions

in order to address an urgent nonroutine 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 be revoked by

EPA on November 30, 1998, under

FFDCA section 408(l)(5), residues of

norflurazon not in excess of the amount

specified in these tolerances remaining

in or on bermudagrass hay and forage

after that date will not be unlawful,

provided the pesticide is applied during

the term of, and in accordance with all

the conditions of, the emergency

exemptions. 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.

EPA has not made any decisions

about whether norflurazon meets the

requirements for registration under

FIFRA section 3 for use on

bermudagrass or whether permanent

tolerances for norflurazon for

bermudagrass hay and forage would be

appropriate. This action by EPA does

not serve as a basis for registration of

norflurazon by a State for special local

needs under FIFRA section 24(c). Nor

does this action serve as the basis for

any States other than Alabama, Georgia,

Louisiana, Mississippi, and Texas to use

this product 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

exemptions for norflurazon, 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.

For many of these 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 percent

or less of the RfD) is generally

considered acceptable by EPA.

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 margin of exposure

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.

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, and other

non-occupational exposures, such as

where residues leach into groundwater

or surface water that is consumed as

drinking water. 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. The

TMRC is a ‘‘worst case’’ estimate since

it is based on the assumptions that food

contains pesticide residues at the

tolerance level and that 100 percent of

the crop is treated by pesticides that

have established tolerances. If the

TMRC exceeds the RfD or poses a

lifetime cancer risk that is greater than

approximately one in a million, EPA

attempts to derive a more accurate

exposure estimate for the pesticide by

evaluating additional types of

information (anticipated residue data

and/or percent of crop treated data)

which show, generally, that pesticide

residues in most foods when they are

eaten are well below established

tolerances.

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.

Norflurazon is registered by EPA for

several agricultural as well as nonagricultural uses. EPA believes it has

sufficient data to assess the hazards of

norflurazon and to make a

determination on aggregate exposure,

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

time-limited tolerances for residues of

norflurazon on bermudagrass hay and

forage. EPA’s assessment of the dietary

exposures and risks associated with

establishing these tolerances follows.

A. Toxicological Profile

1. Chronic toxicity. Based on the

available chronic toxicity data, EPA’s

Office of Pesticide Programs (OPP) has

established the RfD for norflurazon at

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

The RfD was established based on a

NOEL (no observable effect level) of

1.53 mg/kg/day in a 6–month dog

feeding study. The LEL (lowest effect

level) was based on absolute and

relative liver weight and increased

cholesterol levels. An uncertainty factor

(UF) of 100 was used to account for both

inter-species extrapolation and intraspecies variability.

2. Acute toxicity. Agency toxicologists

have recommended that the

developmental NOEL of 30 mg/kg/day

from the rabbit developmental toxicity

study be used for acute dietary risk

calculations. The developmental LEL of

60 mg/kg/day is based on increased

skeletal variations. The population of

concern for this risk assessment is

females 13+ years old.

3. Short-term non-dietary inhalation

and dermal toxicity. OPP recommends

use of the 21–day dermal toxicity study
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17745

in rabbits for short- and intermediateterm MOE calculations.

The NOEL was 375 mg/kg/day and

the LEL of 1,000 mg/kg/day was based

on increased absolute and relative liver

weights, and increased alkaline

phosphatase.

4. Carcinogenicity. Norflurazon is

classified as a ‘‘Group C’’, possible

human carcinogen, by the

Carcinogenicity Peer Review Committee

(CPRC). The CPRC recommended using

the RfD approach for quantification of

human risk.

B. Aggregate Exposure

Tolerances for residues of norflurazon

in or on food/feed commodities are

currently expressed in terms of the

herbicide norflurazon (4-chloro-5-

(methylamino)-2-(alpha, alpha, alphatrifluoro-m-tolyl)-3-(2H)-pyridazinone)

and its desmethyl metabolite 4-chloro-5-

(amino)-2-alpha, alpha, alpha-trifluorom-tolyl)-3(2H)-pyridazinone (40 CFR

180.356, 185.4450, and 186.4450).

Existing norflurazon tolerances for meat,

milk, poultry, and eggs are not expected

to be exceeded and are adequate to

cover any secondary residues which

might occur in animal commodities as

a result of this use on bermudagrass.

For the purpose of assessing chronic

dietary exposure from norflurazon, EPA

assumed tolerance level residues and

100% of crop treated for the proposed

use of norflurazon. These conservative

assumptions result in overestimation of

human dietary exposures.

In examining aggregate exposure,

FQPA directs EPA to consider available

information concerning exposures from

the pesticide residue in food and all

other non-occupational exposures. The

primary non-food sources of exposure

the Agency looks at include drinking

water (whether from groundwater or

surface water), and exposure through

pesticide use in gardens, lawns, or

buildings (residential and other indoor

uses).

Because the Agency lacks sufficient

water-related 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 (RfDs or acute

dietary NOELs) 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

consumption of contaminated water, the

ranges the Agency is continuing to

examine are all below the level that

would cause norflurazon 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

norflurazon 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.

Based on the available studies used in

EPA’s assessment of environmental risk,

norflurazon is persistent and mobile.

The ‘‘Pesticides in Groundwater Data

Base’’ (EPA 734-12-92-001, September

1992) reported sampling of wells for

norflurazon residues in Texas and

California. Texas reported 188 wells

sampled, California reported 6 wells

sampled. No detection of residues were

reported in any of the sampled wells.

There is no established Maximum

Concentration Level (MCL) for residues

of norflurazon in drinking water. No

drinking water health advisory levels

have been established for norflurazon.

Norflurazon is registered for uses,

such as fencerows and around

buildings, that could result in nonoccupational exposure, and EPA

acknowledges that there may be short-

, intermediate-, and long-term nonoccupational, non-dietary exposure

scenarios. At this time, the Agency has

insufficient information to assess the

potential risks from such exposure.

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

norflurazon has a common mechanism

of toxicity with other substances or how

to include this pesticide in a cumulative

risk assessment. Unlike other pesticides

for which EPA has followed a

cumulative risk approach based on a

common mechanism of toxicity,

norflurazon 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 norflurazon has a common

mechanism of toxicity with other

subtances.

C. Safety Determinations for U.S.

Population

Taking into account the completeness

and reliability of the toxicity data, EPA

has concluded that chronic dietary

exposure to norflurazon in food from

published tolerances will utilize 10

percent of the RfD for the U.S.

population. EPA generally has no

concern for chronic exposures below

100 percent of the RfD because the RfD

represents the level at or below which

daily aggregate dietary exposure over a

lifetime will not pose appreciable risks

to human health. The acute dietary
17746 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

exposure endpoint of concern for

norflurazon is developmental. For the

population of concern, females 13+

years, a MOE of 3,000 was calculated.

This MOE value does not exceed the

Agency’s level of concern for acute

dietary exposure. Dietary cancer

concerns are adequately addressed by

the chronic exposure analysis using the

RfD. Short- and intermediate-term

aggrgate risk takes into account

exposure from chronic dietary food and

water plus indoor and outdoor

residential exposure. Short- and

intermediate-term MOE’s for the U.S.

population was calculated to be 11,000.

Despite the potential for exposure to

norflurazon from drinking water and

outdoor residential uses, EPA does not

expect the aggregate exposure to exceed

100% of the RfD or the Agency’s level

of concern for acute, short- and

intermediate-term dietary exposure.

EPA concludes that there is a reasonable

certainty that no harm will result for the

U.S. poulation from aggregate exposure

to norflurazon residues.

D. Determination of Safety for Infants

and Children

FFDCA section 408 provides that EPA

shall apply an additional tenfold margin

of exposure (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 exposure (safety)

will be safe for infants and children.

Margins of exposure (safety) are often

referred to as uncertainty (safety)

factors. EPA believes that reliable data

support using the standard margin of

exposure (usually 100x for combined

inter- and intra-species variability)) and

not the additional ten-fold margin of

exposure 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 margin of exposure. Based

on current toxicological data

requirements, the data base for

norflurazon relative to pre- and postnatal toxicity is complete.

The results of the rabbit

developmental toxicity study required

an acute dietary risk assessment be

performed for additional pre-natal

sensitivity due to skeletal variations.

However, the MOE of 3,000 is adequate

to protect against any pre-natal fetal

risks. In the rabbit developmental

toxicity study, the NOEL of 30 mg/kg/

day was the same for both

developmental and maternal toxicity.

The developmental LEL of 60 mg/kg/

day was based on increased skeletal

variations and decreased mean fetal

weight. The maternal LEL of 60 mg/kg/

day was based on decreased body

weight and abortions. Although there

were developmental effects at 60 mg/kg/

day in rabbit fetuses, these findings only

occurred in the presence of maternal

toxicity. In the rat developmental

toxicity study, the developmental NOEL

was identified at; 400 mg/kg/day (HDT),

while the maternal (systemic) NOEL

was <100 mg/kg/day. The acute dietary

exposure endpoint of concern for

norflurazon is developmental (increased

skeletal variations). For the population

subgroup of concern, females 13+ years,

the calculated Margin of Exposure

(MOE) value is 3,000.

The results of the 2-generation

reproductive toxicity study will be used

to assess the potential for additional

pre- and post-natal sensitivity. The

parental (systemic) NOEL was 10.2 mg/

kg/day and the reproductive NOEL was

50.8 mg/kg/day. The reproductive LEL

of 102.5 mg/kg/day was based on

increased pup deaths, increased

stillborns and decreased lactation index.

These effects occurred in the presence

of maternal toxicity. This indicates that

there is no extra post-natal sensitivity.

The NOEL used to establish the RfD is

approximately 10-fold lower than the

pup NOEL from the reproduction study;

therefore, EPA concludes that reliable

data support use of the standard

uncertainty factor as protecting the

safety of infants and children and that

an additional 10-fold margin of

exposure is unnecessary.

EPA has concluded that the percent of

the RfD that will be utilized by chronic

dietary (food) exposure to residues of

norflurazon ranges from 15% for

nursing infants (<1 year old) up to 47%

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

However, this calculation assumes

tolerance level residues for all

commodities and is therefore an overestimate of dietary risk. Refinement of

the dietary risk assessment by using

anticipated residue data would reduce

dietary exposure. The addition of

potential exposure from norflurazon

residues in drinking water is not

expected to result in an exposure which

would exceed the RfD. Therefore, EPA

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to norflurazon residues.

V. Other Considerations

The metabolism of norflurazon in

plants and animals is adequately

understood for the purposes of this

tolerance. There are no Codex maximum

residue levels established for residues of

norflurazon and its desmethyl

metabolite in or on bremudagrass hay

and forage. The residue of concern, for

the purposes of this tolerance, is

norflurazon and its desmethyl

metabolite. Adequate methods for

purposes of data collection and

enforcement of tolerances for

norflurazon and its desmethyl

metabolite are available. Methods for

determining norflurazon residues are

described in the Pesticide Analytical

Manual, Vol. II.

VI. Conclusion

Therefore, tolerances in connection

with the FIFRA section 18 emergency

exemptions are established for residues

of norflurazon in or on bermudagrass

forage at 2 ppm and bermudagrass hay

at 3 ppm. These tolerances will expire

and be revoked by EPA on November

30, 1998. In addition to the new

tolerance being established, since FQPA

eliminates all distinctions between raw

and processed food, EPA is combining

the tolerances that now appear in

§§ 185.4450 and 186.4450 into

§ 180.356. Subsequently, §§ 185.4450

and 186.4450 are removed.

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 June 10, 1997 file

written objections to any aspect of this

regulation (including the revocation

provision) 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
Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations 17747

statement of the factual issues on which

a hearing is requested, the requestor’s

contentions on such issues, and a

summary of any evidence relied upon

by the requestor (40 CFR 178.27). A

request for a hearing will be granted if

the Administrator determines that the

material submitted shows the following:

There is genuine and substantial issue

of fact; there is a reasonable possibility

that available evidence identified by the

requestor would, if established, resolve

one or more of such issues in favor of

the requestor, taking into account

uncontested claims or facts to the

contrary; and resolution of the factual

issues in the manner sought by the

requestor would be adequate to justify

the action requested (40 CFR 178.32).

Information submitted in connection

with an objection or hearing request

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

A record has been established for this

rulemaking under docket number [OPP–

300470]. A public version of this record,

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 Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, Crystal Mall #2,

1921 Jefferson Davis Highway,

Arlington, VA.

The official record for this

rulemaking, as well as the public

version, as described above, is kept in

paper form. Accordingly, in the event

there are objections and hearing

requests, 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. The official rulemaking record is

the paper record maintained at the

address in ‘‘ADDRESSES’’ at the

beginning of this document.

IX. Regulatory Assessment

Requirements

Under Executive Order 12866 (58 FR

51735, October 4, 1993), this action is

not ‘‘a significant regulatory action’’

and, since this action does not impose

any information collection requirements

as defined by the Paperwork Reduction

Act, 44 U.S.C. 3501 et seq., it is not

subject to review by the Office of

Management and Budget.

This action does not impose any

enforceable duty, or contain any

‘‘unfunded mandates’’ as described in

Title II of the Unfunded Mandates

Reform Act of 1995 (Pub. L. 104-4), or

require prior consultation as specified

by Executive Order 12875 (58 FR 58093,

October 28, 1993), entitled Enhancing

the Intergovernmental Partnership, or

special consideration as required by

Executive Order 12898 (59 FR 7629,

February 16, 1994).

Because FFDCA section 408(l)(6)

permits establishment of this regulation

without a notice of proposed

rulemaking, the regulatory flexibility

analysis requirements of the Regulatory

Flexibility Act, 5 U.S.C. 604(a), do not

apply. Nonetheless, the Agency has

previously assessed whether

establishing tolerances or exemptions

from tolerance, raising tolerance levels,

or expanding exemptions adversely

impact small entities and concluded, as

a generic matter, that there is no adverse

impact. (46 FR 24950) (May 4, 1981).

Under 5 U.S.C. 801(a)(1)(A) of the

Small Business Regulatory Enforcement

Fairness Act of 1996 (Title II of Pub. L.

104-121, 110 Stat. 847), EPA 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 the rule in today’s Federal Register.

This rule is not a ‘‘major rule’’ as

defined by 5 U.S.C. 804(2) of the APA

as amended.

List of Subjects in 40 CFR Parts 180,

185, and 186

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Feed

additive, Food additive, Pesticides and

pests, Reporting and recordkeeping

requirements.

Dated: April 4, 1997.

Stephen L. Johnson,

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. Section 180.356 is amended by

redesignating the existing text as

paragraph (a), adding a paragraph

heading and adding alphabetically three

new entries to the table therein to the

newly redesignated paragraph (a),

adding a new paragraph (b), and

reserving paragraphs (c) and (d) to read

as follows:

§ 180.356 Norflurazon, tolerances for

residues.

(a) General. * * *

Commodity Parts per million

* * * * *

Citrus molasses .................. 1.0

* * * * *

Dried citrus pulp .................. 0.4

* * * * *

Dried hops .......................... 3.0

(b) Section 18 emergency exemptions.

Time-limited tolerances are established

for residues of the herbicide norflurazon

(4-chloro-5-(methylamino)-2-(alpha,

alpha, alpha-trifluoro-m-tolyl)-3-

(2H)pyridazinone) and its desmethyl

metabolite 4-chloro-5-(amino)-2-alpha,

alpha, alpha-trifluoro-m-tolyl)-3(2H)-

pyridazinone in connection with use of

the pesticide under section 18

emergency exemptions granted by EPA.

The tolerances are specified in the

following table. The tolerances expire

and will be revoked on the date

specified in the table by EPA.

Commodity Parts per

million

Expiration/

Revocation

Date

Grasses, Bermuda, Forage2.0 November

30, 1998

Grasses, Bermuda, Hay3.0 November

30, 1998

(c) Tolerances with regional

registration. [Reserved]

(d) Indirect or inadvertent residues.

[Reserved]

PART 185—[AMENDED]

2. In part 185:

a. The authority citation for part 185

continues to read as follows:

Authority: 21 U.S.C. 346a and 348.

§ 185.4450 [Removed]

b. Section 185.4450 is removed.
17748 Federal Register / Vol. 62, No. 70 / Friday, April 11, 1997 / Rules and Regulations

PART 186—[AMENDED]

3. In part 186:

a. The authority citation for part 186

continues to read as follows:

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

§ 186.4450 [Removed]

b. Section 186.4450 is removed.

[FR Doc. 97–9375 Filed 4–10–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

46 CFR Part 2

[CGD 97–001]

RIN 2115–AF41

Delegation of Authority to Officer in

Charge, Marine Inspection.

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

SUMMARY: The Coast Guard is

authorizing Officers in Charge, Marine

Inspection (OCMIs) to redelegate

signature authority for certain vessel

inspection documents. Currently, the

OCMI signs all vessel inspection

documents. This rule will authorize

redelegation of that function to reduce

the number of documents OCMIs must

sign.

DATES: This rule is effective on April 11,

1997.

ADDRESSES: Unless otherwise indicated,

documents referred to in this preamble

are available for inspection or copying

at the office of the Executive Secretary,

Marine Safety Council (G-LRA/3406),

U.S. Coast Guard Headquarters, 2100

Second Street, SW., Washington, DC

20593–0001 between 9:30 a.m. and 2

p.m., Monday through Friday, except

Federal holidays. The telephone number

is (202) 267–1477.

FOR FURTHER INFORMATION CONTACT: LT

Eric Christensen, Project Manager,

Vessel and Facility Operating Standards

Division (G–MSO–2), (202)267–1055.

SUPPLEMENTARY INFORMATION:

Background and Purpose

The delegation of authority from the

Commandant of the Coast Guard to

Officer in Charge, Marine Inspection

gives signature authority to the OCMI

for various inspection documents.

During a recent reorganization, the

Coast Guard established Activity

Commands which combine OCMI,

Captain of the Port (COTP), and Group

functions. Activities are large units that

perform a large number of tasks

including many requiring the OCMI’s

signature. This rule will authorize

redelegation of that signatory function

to reduce the number of vessel

inspection documents OCMIs must sign

personally.

Discussion and Change

The rationale for this change is that

many routine documents don’t require

the personal attention of the OCMI, and

increasing responsibilities of the OCMI

will mean that the official’s attention is

needed more urgently elsewhere.

Regulations currently require the OCMI

to personally sign hundreds of

inspection documents issued by each

Marine Safety Office each year. In many

cases, a new computer-generated

Certificate of Inspection is based on an

administrative change such as

ownership or address and not on any

substantive change in the vessel

particulars. Authority to redelegate

signatory authority would relieve the

OCMI of a substantial paperwork

burden.

The Coast Guard is proceeding

directly to a final rule under section

553(b)(3)(A) of the Administrative

Procedures Act (5 U.S.C. 551 et seq.)

which excludes rulemakings relating to

agency organization, procedure, or

practice from the requirements of public

notice and comment. These changes are

administrative and will not impact the

type or quality of Coast Guard services

performed.

Regulatory Evaluation

This rule is not a significant

regulatory action under section 3(f) of

Executive Order 12866 and does not

require an assessment of potential costs

and benefits under section 6(a)(3) of that

order. It has not been reviewed by the

Office of Management and Budget under

that order. It is not significant under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 FR 11040; February 26, 1979). The

Coast Guard expects the economic

impact of this rule to be so minimal that

a full Regulatory Evaluation under

paragraph 10e of the regulatory policies

and procedures of DOT is unnecessary.

As this rule involves internal Agency

practices and procedures, it will not

impose any costs on the public.

Collection of Information

This rule contains no new collectionof-information requirements under the

Paperwork Reduction Act [44 U.S.C.

3501 et seq.].

Federalism

The Coast Guard has analyzed this

rule under the principles and criteria

contained in Executive Order 12612 and

has determined that this rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Environment

The Coast Guard considered the

environmental impact of this interim

rule and concluded that, under § 2.B.2

of Commandant Instruction M16475.1B,

this rule is categorically excluded from

further environmental documentation.

This exclusion is in accordance with

paragraphs 2.B.2.e.(34) (a) and (b),

concerning regulations that are editorial

or procedural and concerning internal

agency functions or organization. A

Categorical Exclusion Determination is

available in the docket for inspection or

copying where indicated under

ADDRESSES.

List of Subjects in 46 CFR Part 2

Marine safety, Reporting and

recordkeeping requirements, Vessels.

For the reasons set forth in the

preamble, the Coast Guard amends 46

CFR part 2 as follows:

PART 2—VESSEL INSPECTIONS

1. The authority citation for part 2

continues to read as follows:

Authority: 33 U.S.C. 1903; 43 U.S.C. 1333;

46 U.S.C. 3306, 3703; E.O. 12334, 3 CFR,

1980 Comp., p. 277; 49 CFR 1.46; subpart

2.45 also issued under the authority of Act

Dec. 27, 1950, Ch. 1155, secs. 1, 2, 64 Stat.

1120 (see 46 U.S.C. App. note prec. 1).

2. Section 2.01–30 is added to read as

follows:

§ 2.01–30 Delegation of OCMI signature

authority.

The OCMI may redelegate to one

individual on his or her staff authority

to sign documents issued under this

subpart.

Dated: March 31, 1997.

J. C. Card,

Rear Admiral, U.S. Coast Guard, Assistant

Commandant for Marine Safety and

Environmental Protection.

[FR Doc. 97–9409 Filed 4–10–97; 8:45 am]

BILLING CODE 4910–14–P