Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Rules and Regulations 4911

issued a final rule amending its

fireworks regulations under the Federal

Hazardous Substances Act. 61 FR

67197. This final rule changes the

allowable fuse burn times of fireworks

devices (except firecrackers) from the

previously required range of 3 to 6

seconds to the range of 3 to 9 seconds.

Increasing the range will improve safety

by allowing manufacturers to more

consistently produce fireworks that do

not have dangerously short fuse burn

times of below 3 seconds. Further, the

increase in the maximum allowable fuse

burn time to 9 seconds will not create

any additional risk of injury to

consumers.

The procedures established under

section 701(e) of the Food, Drug, and

Cosmetic Act (‘‘FDCA’’) apply to this

rulemaking. 15 U.S.C. 1261(q)(2). These

procedures provide that, once the

Commission issues a final rule, persons

who would be adversely affected by the

rule have 30 days in which to file

objections with the Commission stating

the grounds therefor, and to request a

public hearing on those objections. 21

U.S.C. 371(e). Here, this 30-day period

for objections expired on January 21,

1996.

The Commission is required to

publish a notice in the Federal Register

specifying any parts of the regulation

that have been stayed by the filing of

proper objections or, if no objections

have been filed, stating that fact. By this

notice, the Commission states that no

objections to the final rule were filed in

this proceeding. Accordingly, the rule

will go into effect on February 3, 1997,

the date this notice is published in the

Federal Register.

Dated: January 28, 1997.

Sadye E. Dunn,

Secretary, Consumer Product Safety

Commission.

[FR Doc. 97–2488 Filed 1–31–97; 8:45 am]

BILLING CODE 6355–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300450; FRL–5584–5]

RIN 2070–AB78

Carboxin; Pesticide Tolerances for

Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes a

time-limited tolerance for combined

residues of the fungicide carboxin in or

on the raw agricultural commodity

onion seed in connection with EPA’s

granting of emergency exemptions

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of carboxin on

onion seed in California and New

Jersey. This regulation establishes a

maximum permissible level for residues

of carboxin in this food pursuant to

section 408(l)(6) of the Federal Food,

Drug and Cosmetic Act, as amended by

the Food Quality Protection Act of 1996.

This tolerance will expire and be

revoked automatically without further

action by EPA on January 17, 1998.

DATES: This regulation becomes

effective February 3, 1997. This

regulation expires and is revoked

automatically without further action by

EPA on January 17, 1998. Objections

and requests for hearings must be

received by EPA on April 4, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket number, [OPP–300450], 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 number, [OPP–

300450], should 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,

1921 Jefferson Davis Highway,

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. 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: Stephen Schaible, 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) 308–8337, e-mail:

schaible.stephen@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: EPA, on

its own initiative, pursuant to section

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

Drug, and Cosmetic Act (FFDCA), 21

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

a tolerance for residues of the fungicide

carboxin, 5,6-dihydro-2-methyl-1,4-

oxathiin-3-carboxanilide in or on onions

(dry bulb) at 0.2 part per million (ppm).

This tolerance will expire and be

revoked automatically without further

action by EPA on January 17, 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 were discussed in detail

in the final rule establishing a tolerance

for an emergency exemption for use of

propiconazole on sorghum (61 FR

58135, Nov. 13, 1996).

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
4912 Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Rules and Regulations

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) 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 Exemption for Carboxin

on Onion Seed and FFDCA Tolerances

The California Department of

Pesticide Regulations and the New

Jersey Department of Environmental

Protection requested specific

exemptions for use of carboxin on onion

seed to control onion smut. The loss of

Arasan 50 Red, the fungicide

historically used to control onion smut,

has resulted in an urgent, non-routine

situation for growers. In the past, onion

smut was controlled with thiram 50

percent wettable powder (Arasan 50

Red) seed treatments. However, the

DuPont Company ceased manufacture of

this product in 1985, and growers have

since exhausted existing stocks of

Arasan 50 Red. According to the

Applicants, there are no other registered

pesticides or alternative practices

available that will control this disease.

There are other thiram products

registered for use as onion seed

treatments, but the maximum label rates

are too low to control onion smut.

As part of its assessment of this

application for an emergency

exemption, EPA assessed the potential

risks presented by residues of carboxin

on onion seed. In doing so, EPA

considered the new safety standard in

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

decided to grant the section 18

exemption only after concluding that

the necessary tolerance under FFDCA

section 408(l)(6) would be consistent

with the new safety standard and with

FIFRA section 18. This tolerance for

carboxin will permit the marketing of

onion seed treated in accordance with

the provisions of the section 18

emergency exemptions. Consistent with

the need to move quickly on the

emergency exemptions and to ensure

that the resulting food is safe and

lawful, EPA is issuing this tolerance

without notice and opportunity for

public comment under section 408(e) as

provided in section 408(l)(6). Although

this tolerance will expire and be

revoked automatically without further

action by EPA on December 31, 1997,

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

of carboxin not in excess of the amount

specified in the tolerance remaining in

or on onion seeds 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 this tolerance

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 carboxin meets the

requirements for registration under

FIFRA section 3 for use on onion seeds

or whether a permanent tolerance for

carboxin for onion seeds would be

appropriate. This action by EPA does

not serve as a basis for registration of

carboxin 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 California 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 carboxin, 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 by EPA to pose no

appreciable risk.

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
Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Rules and Regulations 4913

extrapolations or margin of exposure

calculation based on the appropriate

NOEL) may 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 this action.

Carboxin is not registered for residential

use. Uniroyal Chemical Company has

submitted a petition tolerance for the

use of carboxin on onion (dry bulb) to

the Agency; however, it is pending

review. Based on the information

submitted to the Agency, EPA has

sufficient data to assess the hazards of

carboxin and to make a determination

on aggregate exposure, consistent with

section 408(b)(2), for the time-limited

tolerances for residues of carboxin on

onion seed at 0.2 ppm. 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, the

Office of Pesticide Programs (OPP) has

established the RfD for carboxin at 0.1

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

RfD for carboxin is based on a 2–year

feeding study in rats with a NOEL of 10

mg/kg/day and an uncertainty factor of

100. Decreased body weight gain,

increased mortality and decreased organ

weight (heart, kidney, and spleen) was

the effect observed at the Lowest Effect

Level (LEL) of 15 mg/kg/day.

2. Acute toxicity. Based on available

acute toxicity data, OPP has determined

that the NOEL of 75 mg/kg/day from the

developmental toxicity study in rabbits

should be used to assess risk from acute

toxicity. The maternal/developmental

effects observed at the LEL of 375 mg/

kg/day were abortions. The relationship

between abortions produced by direct

maternal toxicity (i.e. stress) and those

effects mediated by reproductive/

developmental mechanisms can not be

clearly differentiated at this time. The

population subgroup of concern for this

risk assessment is females 13 years of

age and older. This subgroup is

representative for both maternal and

fetal effects.

3. Carcinogenicity. Carboxin’s

carcinogenicity has not been classified

by the Reference Dose (RfD) Committee.

However, when last reviewed in 1986,

there was no evidence of

carcinogenicity in rats or mice.

B. Aggregate Exposure

Tolerances for residues of carboxin in

or on food/feed commodities are

currently expressed in terms of the

combined residues (free and bound) of

the fungicide carboxin (5,6-dihydro-2-

methyl-1,4-oxathiin-3-carboxanilide)

and its sulfoxide metabolite (5,6-

dihydro-3-carboxanilide-2-methyl-1,4-

oxathiin-4-oxide), expressed in or on

certain raw agricultural commodities

ranging from 0.01 ppm in eggs to 0.5

ppm in beans, hay, barley and wheat

(see 40 CFR 180.301). For the purpose

of assessing chronic dietary exposure

from carboxin, EPA assumed tolerance

level residues and 100 percent of crop

treated refinements to estimate the

TMRC from all established food uses for

carboxin as well as the proposed use on

onion seed. There are no livestock feed

items associated with this section 18

request, so no additional livestock

dietary burden will result from this

section 18 registration. Therefore,

existing meat/milk/poultry tolerances

are adequate.

Other potential sources of exposure of

the general population to residues of

pesticides are residues in drinking water

and exposure from non-occupational

(non-dietary) sources. Based on the

available studies used in EPA’s

assessment of environmental risk,

carboxin is persistent and leaches into

groundwater. There are no established

Maximum Concentration Levels (MCLs)

for residues of carboxin in drinking

water. Health Advisory (HA) Levels for

carboxin in drinking water for adults are

4 and 0.7 mg/L (longer term and life

time HA levels respectively) and 1 day,

10 day, and longer term HA levels are

all 1 mg/L for children.

The Agency does not have available

data to perform a quantitative drinking

water risk assessment for carboxin at

this time. However, previous experience

with persistent and mobile pesticides

for which there have been available data

to perform quantitative risk assessments

have demonstrated that drinking water

exposure is typically a small percentage

of the total exposure when compared to

the total dietary exposure. This

observation holds even for pesticides

detected in wells and drinking water at

levels nearing or exceeding established

MCLs. Based on this experience and

OPP’s best scientific judgement, and

considering the low percent of the RfD

occupied by dietary exposure estimates

including onion seed (1.0 percent RfD

for U.S. population), EPA does not

anticipate that combined exposure from

drinking water and dietary exposure

would result in a TMRC that exceeds

100 percent of the RfD. Therefore, the

EPA concludes that potential carboxin

residues in drinking water are not likely

to pose a human health concern.

Carboxin is not registered for

residential use. Non-occupational

exposure to the general population is

therefore not expected and not

considered in aggregate exposure

estimates.

At this time, the Agency has not made

a determination that carboxin and other

substances that may have a common

mode of toxicity would have cumulative

effects. Given the time limited nature of

this request, the need to make

emergency exemption decisions

quickly, and the significant scientific

uncertainty at this time about how to

define common mode of toxicity, the

Agency will make its safety

determination for this tolerance based

on those factors which it can reasonably

integrate into a risk assessment. For

purposes of this tolerance only, the

Agency is considering only the potential

risks of carboxin in its aggregate

exposure.
4914 Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Rules and Regulations

C. Safety Determinations For U.S.

Population

EPA has concluded that dietary

exposure to carboxin will utilize 1.0

percent of the RfD for the U.S.

population. As mentioned before, EPA

does not expect that chronic exposure

from drinking water would result in an

aggregate exposure which would exceed

100 percent of the RfD. EPA concludes

that there is a reasonable certainty that

no harm will result from aggregate

exposure to carboxin residues. For the

population subgroup of concern,

females 13+ and older (accounts for

both maternal and fetal exposure), the

calculated Margin of Exposure (MOE)

value is 25,000. MOE values over 100 do

not exceed the Agency’s level of

concern for acute dietary exposure. EPA

concludes that there is a reasonable

certainty that no harm will result from

aggregate exposure to carboxin residues.

D. Determination of Safety for Infants

and Children

In assessing the potential for

additional sensitivity of infants and

children to residues of carboxin, EPA

considered pre- and post-natal toxicity

studies in rat and rabbit and a 2-

generation reproduction study in the rat.

The developmental toxicity study in rats

does not meet current guideline

requirements due to the lack of maternal

or developmental effects. In the

maternal/developmental toxicity study

in the rat the NOEL was >40 mg/kg/day

highest dose tested and the NOEL in

rabbits was 75 mg/kg/day with a LEL of

375 mg/kg/day based on abortions. In

addition, the acute dietary MOE for

pregnant women 13+ years old is

25,000. This large MOE supports the

conclusion that there are no

developmental (prenatal) concerns for

both females 13+ years and the pre-natal

development of infants from aggregate

residues of carboxin.

In the 2-generation reproductive

toxicity study in the rat, the

reproductive/developmental toxicity

NOEL of 10 mg/kg/day was greater than

the parental (systemic) toxicity NOEL of

1 mg/kg/day which demonstrates that

pup toxicity occurred in the presence of

maternal toxicity. This finding suggests

that post-natal development in pups is

not more sensitive and that infants and

children may not be more sensitive to

carboxin than adult animals. This

information, together with the

uncertainty factor of 100 utilized to

calculate the RfD for carboxin, is

considered adequate protection for

infants and children with respect to

prenatal and postnatal development

against dietary exposure to carboxin

residues.

EPA has concluded that the percent of

the RfD that will be utilized by chronic

dietary exposure to residues of carboxin

ranges from 0.7 percent for females 13+

to 2.4 percent for non-nursing infants

(<1 year old). The calculated acute MOE

for the population subgroup of concern,

females 13+ and older, value is 25,000.

Both chronic and acute dietary exposure

risk assessments assume 100 percent

crop treated and use tolerance level

residues for all commodities (TMRC

estimates). Refinement of the dietary

risk assessment by using percent crop

treated and anticipated residue (ARC)

data would reduce dietary exposure.

Therefore, both of these risk

assessments are also an over-estimate of

dietary risk. Consideration of ARC and

percent crop treated would likely result

in an ARC which would occupy a

percent of the RfD that is likely to be

significantly lower than the currently

calculated TMRC value. Additionally,

the acute dietary MOE would be greater

than the current MOE. The addition of

potential exposure from carboxin

residues in drinking water is not

expected to result in an exposure which

would exceed the RfD. EPA therefore

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to carboxin residues.

FFDCA section 408 provides that EPA

shall apply an additional safety factor

for infants and children in the case of

threshold effects to account for pre- and

post-natal toxicity and the completeness

of the data base unless EPA concludes,

based on reliable data, that said

additional safety factor is unnecessary.

Should an additional uncertainty factor

be deemed appropriate, when

considered in conjunction with a refine

exposure estimate, it is unlikely that the

dietary risk will exceed 100 percent of

the RfD. Therefore, EPA concludes that

this tolerance will not pose an

unacceptable risk to infants and

children.

V. Other Considerations

The metabolism of carboxin in plants

and animals is adequately understood

for the purposes of this tolerance. There

are no Codex maximum residue levels

established for residues of carboxin on

onion seed. Adequate methods for

purposes of data collection and

enforcement of tolerance for carboxin

residues are available. Methods for

enforcement of tolerances in/on various

plant and animal commodities are listed

in the Pesticide Analytical Manual

(PAM) Vol. II as Method I and Method

II.

VI. Conclusion

Therefore, a tolerance in connection

with the FIFRA section 18 emergency

exemptions is established for residues of

carboxin on onion seed at 0.2 ppm. This

tolerance will expire and be

automatically revoked without further

action by EPA on January 17, 1998.

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 April 4, 1997, file

written objections to any aspect of this

regulation (including the automatic

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

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
Federal Register / Vol. 62, No. 22 / Monday, February 3, 1997 / Rules and Regulations 4915

may be claimed confidential by marking

any part or all of that information as

Confidential Business Information (CBI).

Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the information that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

may be disclosed publicly by EPA

without prior notice.

VIII. Public Docket

EPA has established a record for this

rulemaking under docket number [OPP–

300450] (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 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.

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, 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. In addition,

this action does not impose any

enforceable duty or contain any

unfunded mandate as described in the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4), or require prior

consultation with State officials as

specified by Executive Order 12875 (58

FR 58093, October 28, 1993), or special

considerations 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.

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

Administrative Procedure Act (APA) as

amended by 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 Part 180

Environmental protection,

Administrative practice and procedure,

Agricultural commodities, Pesticides

and pests, Reporting and recordkeeping

requirements.

Dated: January 21, 1997.

Daniel M. Barolo,

Director, Office of Pesticide Programs.

Therefore, 40 CFR Chapter I is

amended as follows:

PART 180—[AMENDED]

1. The authority citation for part 180

continues to read as follows:

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

2. In § 180.301, by designated the

existing text as paragraph (a) and by

adding a new paragraph (b) to read as

follows:

§ 180.301 Carboxin; tolerances for residues.

* * * * *

(b) A time-limited tolerance is

established for residues of the combined

residues (free and bound) of the

fungicide carboxin [5,6-dihydro-2-

methyl-1,4-oxathiin-3-carboxanilide)

and its sulfoxide metabolite (5,6-

dihydro-3-carboxanilide-2-methyl-1,4-

oxathiin-4-oxide), each expressed as the

parent compound in connection with

use of the pesticide under section 18

emergency exemptions granted by EPA.

The tolerance is specified in the

following table. The tolerance expires

and is automatically revoked on the date

specified in the table without further

action by EPA.

Commodity Parts per million Expiration/Revocation Date

Onion Seed .................................................................................................................... 0.2 January 17, 1998

[FR Doc. 97–2500 Filed 1–31–97; 8:45 am]

BILLING CODE 6560–50–F

FEDERAL EMERGENCY

MANAGEMENT AGENCY

44 CFR Part 64

[Docket No. FEMA–7658]

Suspension of Community Eligibility

AGENCY: Federal Emergency

Management Agency, FEMA.

ACTION: Final rule.

SUMMARY: This rule identifies

communities, where the sale of flood

insurance has been authorized under

the National Flood Insurance Program

(NFIP), that are suspended on the

effective dates listed within this rule

because of noncompliance with the

floodplain management requirements of

the program. If the Federal Emergency

Management Agency (FEMA) receives

documentation that the community has

adopted the required floodplain

management measures prior to the

effective suspension date given in this

rule, the suspension will be withdrawn

by publication in the Federal Register.

EFFECTIVE DATES: The effective date of

each community’s suspension is the

third date (‘‘Susp.’’) listed in the third

column of the following tables.

ADDRESSES: If you wish to determine

whether a particular community was

suspended on the suspension date,

contact the appropriate FEMA Regional

Office or the NFIP servicing contractor.

FOR FURTHER INFORMATION CONTACT:

Robert F. Shea Jr., Division Director,

Program Implementation Division,

Mitigation Directorate, 500 C Street,