1288 Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations

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 March 10, 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

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–

300447] (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 4:00

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 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 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 2, 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 § 180.443, by adding a new

paragraph (d) to read as follows:

§ 180.443 Myclobutanil; tolerances for

residues.

* * * * *

(d) A time-limited tolerance is

established for residues of the fungicide

myclobutanil, in connection with use of

the pesticide under section 18

emergency exemption granted by EPA.

The tolerance is specified in the

following table. This 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

Cucurbit vegetables.0.3 Nov. 30, 1997.

[FR Doc. 97–514 Filed 1–8–97; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 180

[OPP–300448; FRL–5581–9]

RIN 2070–AB78

Zinc Phosphide; Pesticide Tolerances

for Emergency Exemptions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Final rule.

SUMMARY: This regulation establishes

time-limited tolerances for residues of

phosphine resulting from the use of the

rodenticide zinc phosphide in or on the
Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations 1289

raw agricultural commodities sugarbeets

and potatoes in connection with crisis

exemptions declared by the state of

Idaho under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of zinc phosphide

on sugarbeets and potatoes. This

regulation establishes maximum

permissible levels for residues of

phosphine 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 automatically without further

action by EPA on October 15, 1997.

DATES: This regulation becomes

effective January 9, 1997. This

regulation expires and is revoked

automatically without further action by

EPA on October 15, 1997. Objections

and requests for hearings must be

received by EPA on or before March 10,

1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket number, [OPP–300448], 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–

300448], 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,

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 number [OPP–300448]. 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: 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

a tolerance for residues of the

phosphine resulting from the use of the

rodenticide zinc phosphide in or on

potatoes and sugar beet roots at 0.05

part per million (ppm) and in or on

sugar beet tops at 0.1 ppm. These

tolerances will expire and be revoked

automatically without further action by

EPA on October 15, 1997.

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 CFR 58135, 11/13/96).

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) 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 Zinc

Phosphide on Potatoes and Sugar beets

and FFDCA Tolerances

On August 5, 1996, the Idaho

Department of Agriculture availed itself

of the authority to declare the existence
1290 Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations

of a crisis situation within the state,

thereby authorizing use under FIFRA

section 18 of zinc phosphide on

potatoes and sugar beets for control of

meadow voles and field mice. Potato

and sugarbeet growers in Idaho have

experienced substantial losses in recent

years due to vole and mouse damage.

The only registered option available to

sugarbeet and potato growers in Idaho is

to use zinc phosphide on non-crop land

surrounding their fields. Where fields

are surrounded by other crops or bare

ground, there are no registered controls

or other effective non-chemical

methods.

As part of its assessment of this crisis

exemption, EPA assessed the potential

risks presented by residues of

phosphine on potatoes and sugar beets.

In doing so, EPA considered the new

safety standard in FFDCA section

408(b)(2), and EPA decided that the

necessary tolerance under FFDCA

section 408(l)(6) would clearly be

consistent with the new safety standard

and with FIFRA section 18. These

tolerances for residues of phosphine

will permit the marketing of potatoes

and sugar beets 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 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 automatically without further

action by EPA on October 15, 1997,

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

of phosphine not in excess of the

amount specified in these tolerances

remaining in or on potatoes and sugar

beet roots and tops 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 zinc phosphide meets the

requirements for registration under

FIFRA section 3 for use on potatoes or

sugar beets or whether permanent

tolerances for zinc phosphide for

potatoes, or sugar beet roots or tops

would be appropriate. This action by

EPA does not serve as a basis for

registration of zinc phosphide 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

Idaho to use this product on these crops

under section 18 of FIFRA without

following all provisions of section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemptions for zinc

phosphide, 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

(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.

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.

Zinc phosphide is already registered by

EPA for outdoor residential lawn,

nursery, right-of-way, recreational area

and other non-food uses, as well as

several food use registrations. EPA has

also assessed the toxicology data base

for zinc phosphide in its evaluation of

an application for a regional registration

on sugarbeets. Phosphine is a highly

reactive gas that reacts with raw

agricultural commodities to form bound

phosphate residues. The Agency stated

in a Registration Standard for Zinc
Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations 1291

Phosphide (June 23, 1982) that a

tolerance of 0.1 ppm for phosphine

resulting from the use of zinc phosphide

would be allowable for raw agricultural

commodities, provided the bound

phosphate residues can be fully

characterized. At the time the

registration standard was issued, the

Agency identified 70 percent of the

bound phosphate residues in treated

commodities as consisting of oxy-acids

of phosphorus, which are considered

toxicologically insignificant at the levels

found in treated commodities. Data have

since been submitted which

demonstrate that the remaining 30

percent of residues consists of oxidation

products of phosphine (oxyphosphorus

acids and/or their salts), which are also

considered toxicologically insignificant

at the levels found in treated

commodities. EPA believes it has

sufficient data to assess the hazards of

zinc phosphide and to make a

determination on aggregate exposure,

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

time-limited tolerances for residues of

phosphine resulting from the use of zinc

phosphide in or on potatoes and sugar

beet roots at 0.05 ppm and in or on

sugar beet tops at 0.1 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 zinc phosphide

at 0.0003 milligrams(mg)/kilogram(kg)/

day. The RfD was established based on

an lowest effect level (LEL) of 3.48 mg/

kg/day from an open literature 90–day

rat feeding study. Effects observed at the

LEL were decreased food consumption

and body weight. An uncertainty factor

of 10,000 was used due to data gaps and

the absence of a NOEL in the study.

2. Acute toxicity. No toxicology

studies were identified by OPP which

demonstrated the need for an acute

dietary risk assessment.

3. Short-term non-dietary inhalation

and dermal toxicity. Since 10 percent

zinc phosphide tracking powder has

been classified in Toxicity Category IV

(LC50 >19.6 mg/L), inhalation exposure

resulting from this section 18 action is

not considered toxicologically

significant. For short-term and

intermediate dermal MOE calculations,

the Health Effects Division (HED), of

OPP recommended use of the adjusted

acute dermal LD50 NOEL of 1,000 mg/

kg from the acute dermal toxicity study

in rabbits. In the absence of other

dermal toxicity data, the acute NOEL

dose of 1,000 mg/kg was divided by a

100–fold uncertainty factor to

approximate a 3–month dermal NOEL

for worker dermal exposure. The 3

month dermal NOEL is 10 mg/kg/day.

At the LEL of 2,000 mg/kg in the rabbit

dermal LD50 study, the animals lost

weight, but no mortalities were

observed up to 5,000 mg/kg highest dose

tested (HDT). Actual risk from dermal

exposure is likely to be significantly

less, since zinc phosphide reacts with

water and stomach acid to produce the

toxic gas phosphine from oral, but not

dermal, exposure.

4. Carcinogenicity. Zinc phosphide

has not been reviewed for

carcinogenicity, as there are no adequate

carcinogenicity studies in rodents

available in the toxicology data base.

OPP has waived carcinogenicity data

requirements for zinc phosphide on the

basis that exposures to zinc phosphide

are controlled to prevent exposures to

humans. Applications to crop areas are

such that the zinc phosphide will

dissipate.

B. Aggregate Exposure

Tolerances are established for

residues of the phosphine resulting from

the use of zinc phosphide on several

raw agricultural commodities (40 CFR

180.284(a) and (b)). There is no

reasonable expectation of secondary

residues in meat, milk, poultry, or eggs

(paragraph (a)(3) of 40 CFR 180.6). Any

residues of zinc phosphide ingested by

livestock would be metabolized to

naturally occurring phosphorous

compounds.

For the purpose of assessing chronic

dietary exposure from zinc phosphide,

EPA assumed tolerance level residues

and 100 percent of crop treated for the

proposed and existing food uses of zinc

phosphide. These conservative

assumptions result in overestimation of

human dietary exposures.

Other potential sources of exposure of

the general population to residues of

pesticides are residues in drinking water

and exposure from non-occupational

sources. There is no information on zinc

phosphide (phosphine) residues in

ground water and runoff in the EFED

One-Liner Data Base. There is no

established Maximum Concentration

Level (M.C.L.) for residues of zinc

phosphide (phosphine) in drinking

water. No drinking water health

advisory levels have been established

for zinc phosphide (phosphine). There

is no entry for zinc phosphide

(phosphine) in the ‘‘Pesticides in

Groundwater Database’’ (EPA 734–12–

92–001, September 1992). Based on the

available studies used in EPA’s

assessment of environmental risk, EPA

does not anticipate exposure to residues

of zinc phosphide (phosphine) in

drinking water.

There are residential uses of zinc

phosphide and EPA acknowledges that

there may be short-, intermediate-, and

long-term non-occupational, non-dietary

exposure scenarios. OPP has identified

a toxicity endpoint for an intermediateterm residential risk assessment.

However, no acceptable reliable dermal

exposure data to assess these potential

risks are available at this time. 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 aggregate non-occupational

exposure with dietary exposure, the

Agency will make its safety

determination for these tolerances based

on those factors which it can reasonably

integrate into a risk assessment.

At this time, the Agency has not made

a determination that zinc phosphide

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 these tolerances based

on those factors which can reasonably

integrate into a risk assessment. For

purposes of these tolerances only, the

Agency is considering only the potential

risks of zinc phosphide in its aggregate

exposure.

C. Safety Determinations For U.S.

Population

Taking into account the completeness

and reliability of the toxicity data, EPA

has concluded that dietary exposure to

zinc phosphide will utilize 27.5 percent

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

does not anticipate chronic exposure to

residues of zinc phosphide (phosphine)

in drinking water. EPA concludes that

there is a reasonable certainty that no

harm will result from aggregate

exposure to zinc phosphide residues.

D. Determination of Safety for Infants

and Children

There were no developmental

findings in rats up to a maternally toxic

dose of 4.0 mg/kg/day zinc phosphide

nor in mice at 4.0 mg/kg/day (HDT). A

comparison of the NOEL of 0.1 mg/kg/

day in the recent 90–day rat gavage

study and the NOELs for developmental

toxicity in rats and mice (4.0 mg/kg/day)

provides a 40–fold difference, which

demonstrates that there are no special

pre-natal sensitivities for infants and

children. Since there are no
1292 Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations

reproduction studies with zinc

phosphide, the post-natal potential for

effects from zinc phosphide in infants

and children cannot be fully evaluated.

However, the above information,

together with the uncertainty factor of

10,000 utilized to calculate the RfD for

zinc phosphide, is considered adequate

protection for infants and children with

respect to prenatal and postnatal

development against dietary exposure to

zinc phosphide residues.

EPA has concluded that the percent of

the RfD that will be utilized by chronic

dietary exposure to residues of zinc

phosphide ranges from 6.8 percent for

nursing infants (<1 year old) up to 59.9

percent for children 1 to 6 years 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. As mentioned before,

EPA does not expect chronic exposure

from drinking water. EPA therefore

concludes that there is a reasonable

certainty that no harm will result to

infants and children from aggregate

exposure to zinc phosphide.

V. Other Considerations

The metabolism of zinc phosphide in

plants and animals is adequately

understood for the purposes of these

tolerances. The residue of concern is

unreacted zinc phosphide, measured as

phosphine, that may be present.

Adequate methods for purposes of data

collection and enforcement of tolerances

for zinc phosphide residues as

phosphine gas are available. Methods

for determining zinc phosphide residues

of phoshine gas are described in PAM,

Vol. II, as Method A.

VI. Conclusion

Therefore, tolerances in connection

with the FIFRA section 18 emergency

exemptions are established for residues

of phosphine resulting from the use of

zinc phosphide in potatoes and sugar

beet roots at 0.05 ppm and sugar beet

tops at 0.1 ppm. These tolerances will

expire and be automatically revoked

without further action by EPA on

October 15, 1997.

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 March 10, 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

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–

300448] (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 4:00

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 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 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
Federal Register / Vol. 62, No. 6 / Thursday, January 9, 1997 / Rules and Regulations 1293

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 2, 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 § 180.284, by adding a new

paragraph (c) to read as follows:

§ 180.284 Zinc phosphide; tolerances for

residues.

* * * * *

(c) Time-limited tolerances are

established for residues of the

phosphine resulting from the use of the

rodenticide zinc phosphide 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 are automatically

revoked on the date specified in the

table without further action by EPA.

Commodity

Parts

per million

Expiration/

Revocation

Date

Potatoes ................ 0.05 October 15,

1997

Sugar beet (roots) 0.05 October 15,

1997

Sugar beet (tops) .. 0.1 October 15,

1997

[FR Doc. 97–512 Filed 1–8–97; 8:45 am]

BILLING CODE 6560–50–F

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

49 CFR Parts 382, 383, and 390

[FHWA Docket No. MC–93–17]

RIN 2125–AE13

Federal Motor Carrier Safety

Regulations; Intermodal

Transportation; Withdrawal of Final

Rule

AGENCY: Federal Highway

Administration (FHWA), DOT.

ACTION: Final rule; withdrawal.

SUMMARY: On December 29, 1994, the

FHWA published a final rule [59 FR

67544] which implemented the

Intermodal Safe Container

Transportation Act of 1992 (the 1992

Act). On October 11, 1996, the President

signed the Intermodal Safe Container

Transportation Amendments Act of

1996 (the 1996 Act) which substantially

amended the 1992 Act and removed the

requirement that the Secretary of

Transportation promulgate

implementing regulations. The FHWA,

therefore, is withdrawing its December

29 final rule. The FHWA has

determined that regulations are not

necessary to implement the 1992 Act as

amended by the 1996 Act. The 1996 Act

will become effective on April 9, 1997.

The FHA is also amending the

applicability provisions of the

regulations on controlled substances

and alcohol use and testing.

EFFECTIVE DATE: January 9, 1997.

FOR FURTHER INFORMATION CONTACT: Mr.

Peter C. Chandler, Office of Motor

Carrier Research and Standards, (202)

366–5763; or Mr. Charles E. Medalen,

Office of the Chief Counsel, (202) 366–

1354, Federal Highway Administration,

400 Seventh Street, SW., Washington,

DC 20590. Office hours are from 7:45

a.m. to 4:15 p.m., e.t., Monday through

Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background and Summary of the 1992

Act

Almost every intermodal container

and trailer travels over the highway at

least once during shipment. Motor

carriers are usually at the beginning or

end of the intermodal transportation

chain. It is difficult for motor carriers to

comply with highway weight

limitations without knowledge of the

weight and transportation

characteristics of the contents of a

container or trailer. The purpose of

highway weight laws is to minimize

highway and bridge wear and protect

the motoring public.

In the 1980s, motor carriers

complained that they had little or no

control over the loading of the

containers or trailers, were forced to

accept containers and trailers with an

unknown cargo and weight by threat of

economic retaliation, and yet were held

responsible for compliance with weight

laws. A motor carrier might suspect that

a loaded container or trailer was too

heavy for the equipment or illegal under

State law, but would have no reasonable

grounds for refusing to transport it

without knowledge of the cargo weight.

On October 28, 1992, the President

signed the Intermodal Safe Container

Transportation Act of 1992 (the 1992

Act) [Pub. L. 102–548, 106 Stat. 3646,

partly codified at 49 U.S.C. 5901–5907

(formerly 49 U.S.C. 501 and 508)]. The

1992 Act requires the person who loads

an intermodal container or trailer to

prepare a written certification that

includes a reasonable description and

the actual gross weight of the cargo, and

to give the certification to the initial

carrier. Each carrier is required to

forward the certification to the next

carrier transporting the container or

trailer. The information will enable

motor carriers, which are already

familiar with the tare weights of

containers, trailers, and chassis, to

better estimate the axle weights and

gross weight of a given combination. If

the certified cargo weight is incorrect

and the motor carrier is fined for

operating an overweight vehicle as a

result of that error, the motor carrier has

a lien on the cargo until the shipper or

owner of the cargo reimburses it for the

fine and all costs associated with the

incident. Coercing a person to transport

a loaded container or trailer without a

certification or with a weight that would

make the vehicle combination illegally

overweight under applicable State law

was prohibited by the 1992 Act.

Summary of Events Between the

Enactment of the 1992 Act and the 1996

Act

The FHWA published a notice of

proposed rulemaking (NPRM) on July

14, 1993 (58 FR 37895). The NPRM

proposed to amend part 390 of the

Federal Motor Carrier Safety

Regulations (FMCSRs) by adding a new

Subpart C, Intermodal Transportation.

Most of the proposed regulations simply

codified the statutory requirements. The

comment period for the NPRM

originally closed on September 13,

1993. In response to several requests,

the FHWA reopened the comment

period and extended it until October 28,

1993.