Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations 7679

the levels of ECH and PO set out in

current § 173.25(a)(20) are in error

because those levels do not reflect the

levels presently used by industry to

manufacture the resin. The information

in the present petition establishes that

the manufacturing process and the resin

composition do not differ from the

process and resin composition

evaluated in the original petition.

Because the composition of the resin is

unchanged, the exposure to the residues

of ECH and PO remains unchanged.

Therefore, the agency concludes that the

agency’s safety evaluation conducted for

the original petition (FAP 6A3905)

supports the safety of the amendment to

§ 173.25 proposed by FAP 6A4500.

Accordingly, the agency concludes that

a recalculation of a risk assessment

performed for the original petition (FAP

6A3905) is not necessary to support this

action.

Thus, FDA has evaluated the data in

the petition and other relevant material.

Based on this information, the agency

concludes that: (1) The proposed use of

the additive is safe; (2) the additive will

achieve its intended technical effect;

and that therefore, (3) the regulations in

§ 173.25 should be amended as set forth

below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in § 171.1(h),

the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has determined under 21

CFR 25.24(a)(9) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Any person who will be adversely

affected by this regulation may at any

time on or before March 21, 1997, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

List of Subjects in 21 CFR Part 173

Food additives.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 173 is

amended as follows:

PART 173—SECONDARY DIRECT

FOOD ADDITIVES PERMITTED IN

FOOD FOR HUMAN CONSUMPTION

1. The authority citation for 21 CFR

part 173 continues to read as follows:

Authority: Secs. 201, 402, 409 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348).

2. Section 173.25 is amended by

revising paragraph (a)(20) to read as

follows:

§ 173.25 Ion-exchange resins.

* * * * *

(a) * * *

(20) Regenerated cellulose, crosslinked and alkylated with

epichlorohydrin and propylene oxide,

then sulfonated whereby the amount of

epichlorohydrin plus propylene oxide

employed does not exceed 250 percent

by weight of the starting quantity of

cellulose.

* * * * *

Dated: February 11, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–4082 Filed 2–19–97; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[OPP–300453; FRL–5588–1]

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

raw agricultural commodities timothy

(seed, forage, hay), alfalfa (forage, hay),

and clover (forage, hay) in connection

with EPA’s granting of an emergency

exemption to the state of Washington

under section 18 of the Federal

Insecticide, Fungicide, and Rodenticide

Act authorizing use of zinc phosphide

on timothy or timothy-alfalfa, clover

stands. 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 on April 15, 1998.

DATES: This regulation is effective

February 20, 1997. The entries in the

table expire on April 15, 1998.

Objections and requests for hearings

must be received by EPA on or before

April 21, 1997.

ADDRESSES: Written objections and

hearing requests, identified by the

docket control number, [OPP–300453],

must be submitted to: Hearing Clerk

(1900), Environmental Protection

Agency, Room M3708, 401 M St., SW.,

Washington, DC 20460. Fees

accompanying objections and hearing

requests shall be labeled ‘‘Tolerance

Petition Fees’’ and forwarded to: EPA

Headquarters Accounting Operations

Branch, OPP (Tolerance Fees), P.O. Box

360277M, Pittsburgh, PA 15251. A copy

of any objections and hearing requests

filed with the Hearing Clerk identified

by the docket control number, [OPP–

300453], 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: Crystal Mall #2,

Room 1132, 1921 Jefferson Davis

Highway, Arlington, VA.
7680 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations

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–

300453]. 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,

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

timothy (seed, forage, hay), alfalfa

(forage, hay), and clover (forage, hay) at

0.1 part per million (ppm). These

tolerances will expire and be revoked

automatically without further action by

EPA on April 15, 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 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 FFDCA 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.’’

FFCDA 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.

FFDCA 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.

FFDCA 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. FFDCA section

408(l)(6) also requires EPA to

promulgate regulations by August 3,

1997, governing the establishment of

tolerances and exemptions under

FFDCA section 408(l)(6) and requires

that the regulations be consistent with

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

FIFRA section 18.

FFDCA 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 FFDCA 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

FFDCA section 408(l)(6) procedural

regulation and before EPA makes its

broad policy decisions concerning the

interpretation and implementation of

the new FFDCA section 408, EPA does

not intend to set precedents for the

application of FFDCA 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 Timothy and Timothyalfalfa/clover and FFDCA Tolerances

EPA has authorized use under FIFRA

section 18 of zinc phosphide on timothy

and timothy-alfalfa/clover for control of

the vole complex. A potential

population of 500 voles per acre would

mean significant economic loss during

1997. The currently available methods

of control, including the use of zinc

phosphide bait boxes and flood

irrigation, are inadequate and

impractical.

As part of its assessment of this

specific exemption, EPA assessed the

potential risks presented by residues of

phosphine on timothy (seed, forage,

hay), alfalfa (forage, hay), and clover

(forage, hay). 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

phosphine will permit the marketing of

timothy and timothy-alfalfa/clover

treated in accordance with the

provisions of the FIFRA section 18-

emergency exemptions. Consistent with

the need to move quickly on this

emergency exemption and in order to

address an urgent non-routine situation

and to ensure that the resulting food is

safe and lawful, EPA is issuing these

tolerances without notice and

opportunity for public comment under

FFDCA section 408(e) as provided in

FFDCA section 408(l)(6). Although these

tolerances will expire and be revoked

automatically without further action by

EPA on April 15, 1998, under FFDCA

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

not in excess of the amount specified in

these tolerances remaining in or on

timothy (seed, forage, hay), alfalfa

(forage, hay), and clover (forage, hay)

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
Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations 7681

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 timothy and

timothy-alfalfa/clover or whether

permanent tolerances for zinc

phosphide for timothy (seed, forage,

hay), alfalfa (forage, hay), and clover

(forage, hay) 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 Washington to use this

product on these crops under FIFRA

section 18 without following all

provisions of FIFRA section 18 as

identified in 40 CFR part 166. For

additional information regarding the

emergency exemption for zinc

phosphide, contact the Agency’s

Registration Division at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

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, by using a dose that causes

adverse effects (threshold effects) and a

dose that causes no observed effect

levels (NOELs).

Once a study has been evaluated and

the observed effects have been

determined to be threshold effects, EPA

generally divides the NOEL from the

study with the lowest NOEL by an

uncertainty factor (usually 100 or more)

to determine the reference dose (RfD).

The RfD is a level at or below which

daily aggregate exposure over a lifetime

will not pose appreciable risks to

human health. An uncertainty factor

(sometimes called a ‘‘safety factor’’) of

100 is commonly used since it is

assumed that people may be up to 10

times more sensitive to pesticides than

the test animals and that one person or

subgroup of the population (such as

infants and children) could be up to 10

times more sensitive to a pesticide than

another. In addition, EPA assesses the

potential risks to infants and children

based on the weight of the evidence of

the toxicology studies and determines

whether an additional uncertainty factor

is warranted. Thus, an aggregate daily

exposure to a pesticide residue at or

below the RfD (expressed as 100% or

less of the RfD) is generally considered

acceptable by EPA.

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% 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 FFDCA 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. 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

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% of the bound

phosphate residues in treated

commodities as consisting of

oxyphosphorus acids, which are

considered toxicologically insignificant

at the levels found in treated

commodities. Data have since been

submitted which demonstrate that the

remaining 30% 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 FFDCA

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

tolerances for residues of phosphine

resulting from the use of zinc phosphide

in or on timothy (seed, forage, hay),

alfalfa (forage, hay), and clover (forage,

hay) at 0.1 part per million (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, EPA’s

Office of Pesticide Programs (OPP) has

established the RfD for zinc phosphide

at 0.0003 milligram(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. The

Agency has recently reviewed a 90-day

gavage study in rats which had a NOEL
7682 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations

of 0.1 mg/kg/day and a LEL of 1.0 mg/

kg/day. The LEL of 1.0 mg/kg/day was

based on increased mortality and kidney

nephrosis in male rats.

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% zinc

phosphide tracking powder has been

classified in Toxicity Category IV (LC50

> 19.6 mg/liter (L)), inhalation exposure

resulting from this FIFRA section 18

action is not considered toxicologically

significant. For short-term and

intermediate dermal MOE calculations,

EPA’s Health Effects Division (HED),

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. 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

1. Tolerances are already 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

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

zinc phosphide ingested by livestock

would be metabolized to naturally

occurring phosphorous compounds. No

human food items are derived from

timothy grown for seed or mixed stands

of timothy-alfalfa/clover produced for

hay. Therefore, humans will receive no

additional dietary exposure to

phosphine as a result of establishment

of this tolerance.

2. For the purpose of assessing

chronic dietary exposure from zinc

phosphide, EPA assumed tolerance

level residues and 100% of crop treated

for the proposed and existing food uses

of zinc phosphide. These conservative

assumptions result in over estimation of

human dietary exposures.

3. 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 EPA’s

Environmental Fate and Effects Division

(EFED) One-Liner Data Base. There is no

established maximum concentration

level (MCL) 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.

4. 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.

5. 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

No human food items are derived

from timothy grown for seed or mixed

stands of timothy-alfalfa/clover

produced for hay. Taking into account

the completeness and reliability of the

toxicity data, EPA has concluded that

dietary exposure to zinc phosphide from

published tolerances (including recently

published time-limited tolerances for

potatoes and sugar beets) will utilize

27.5% of the RfD for the U.S.

population. EPA does not anticipate

chronic exposure to residues of zinc

phosphide (phosphine) in drinking

water.

D. Determination of Safety for Infants

and Children

1. 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

prenatal sensitivities for infants and

children. OPP has waived teratogenicity

in the rabbit and the two-generation

reproduction study in the rat 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. Since there are no

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, and therefore,

EPA has determined that an additional

10-fold safety factor is not appropriate.

2. 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% for

nursing infants (<1 year old) up to

59.9% for children 1 to 6 years old.

However, this calculation assumes

tolerance level residues for all

commodities and is therefore an over

estimate of dietary risk. Refinement of

the dietary risk assessment by using

anticipated residue data would reduce

dietary exposure. As mentioned before,
Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations 7683

EPA does not expect chronic exposure

from drinking water.

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 phosphine gas are described in PAM,

Vol. II, as Method A. There are no

Codex tolerances for timothy (seed,

forage, hay), alfalfa (forage, hay), and

clover (forage, hay).

VI. Conclusion

EPA concludes that there is a

reasonable certainty of no harm to

consumers, including infants and

children, from aggregate exposure to

zinc phosphide based on the following

considerations. First, approval of these

tolerances results in no additional

exposure to consumers. Second, EPA

has used a 10,000-fold safety factor in

assessing the risk estimate posed by zinc

phosphide. Third, this pesticide is being

used to address an emergency situation

and EPA, therefore, must make a quick

decision. Fourth, because these

tolerances are for an emergency

situation, extended use under these

tolerances are not authorized. 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 timothy (seed, forage, hay), alfalfa

(forage, hay), and clover (forage, hay) at

0.1 part per million (ppm). These

tolerances will expire and be

automatically revoked without further

action by EPA on April 15, 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

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

provided in the old FFDCA section 408

and 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 21, 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 in ‘‘ADDRESSES’’ at the

beginning of this document (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 Record

A record has been established for this

rulemaking under docket control

number [OPP–300453]. 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 rule.

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).

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’’ asdefined

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: February 6, 1997.

Peter Caulkins,

Acting Director, Office of Pesticide Programs.
7684 Federal Register / Vol. 62, No. 34 / Thursday, February 20, 1997 / Rules and Regulations

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, paragraph (c) is

amended by revising the introductory

text and adding in alphabetical order

new entries to the table to read as

follows:

§ 180.284 Zinc phosphide, tolerances for

residues.

* * * * *

(c) Time-limited tolerances are

established for residues of phosphine

resulting from the use of the rodenticide

zinc phosphide in connection with use

of the pesticide under FIFRA section 18

emergency exemptions granted by EPA.

The tolerances are specified in the

following table. The tolerances expire

on the date specified in the table.

Commodity

Parts

per million

Expiration/

Revocation

Date

Alfalfa (forage) .... 0.1 April 15, 1998

Alfalfa (hay) ......... 0.1 April 15, 1998

Clover (forage) .... 0.1 April 15, 1998

Clover (hay) ........ 0.1 April 15, 1998

* * * * *

Timothy (forage) 0.1 April 15, 1998

Timothy (hay) ...... 0.1 April 15, 1998

Timothy (seed) .... 0.1 April 15, 1998

[FR Doc. 97–3931 Filed 2–19–97; 8:45 am]

BILLING CODE 6560–50–F

40 CFR Part 261

[SW–FRL–5690–6]

Hazardous Waste Management

System; Identification and Listing of

Hazardous Waste; Amendment

AGENCY: Environmental Protection

Agency.

ACTION: Final rule; amendment.

SUMMARY: The Environmental Protection

Agency (EPA or the Agency) is

amending 40 CFR part 261, appendix IX

to reflect changes in ownership and

name for United Technologies

Automotive, Inc., Jeffersonville, Indiana.

Today’s amendment documents these

changes.

EFFECTIVE DATE: February 20, 1997.

FOR FURTHER INFORMATION CONTACT:

RCRA Hotline, toll free at (800) 424–

9346 or at (703) 412–9810. For technical

information contact Ms. Judy Kleiman,

Waste Management Branch (DRP–8J),

Waste, Pesticides and Toxics Division,

U.S. Environmental Protection Agency,

77 W. Jackson Blvd, Chicago, IL 60604,

(312) 886–1482.

SUPPLEMENTARY INFORMATION: In this

document EPA is amending appendix

IX to part 261 to reflect changes in the

ownership and name for United

Technologies Automotive. The petition

process under §§ 260.20 and 260.22

allows facilities to demonstrate that a

specific waste from a particular

generating facility should not be

regulated as a hazardous waste. Based

on waste specific information provided

by the petitioner, EPA granted an

exclusion to United Technologies

Automotive on April 29, 1986, for F019

wastes at its Jeffersonville, Indiana,

facility (51 FR 15888). On November 20,

1995, Region 5 received notice that

ownership of the United Technologies

Automotive facility in Jeffersonville,

Indiana, was transferred to Profile

Extrusion Company. On November 14,

1996, Region 5 received notice that

ownership of Profile Extrusion

Company was transferred to Alumnitec,

Inc.

In this notification Alumnitec noted

that no changes had been made in the

management of the F019 waste excluded

by the Agency, and that all conditions

of the exclusion will continue to be met.

Today’s notice documents this change

by updating Appendix IX to incorporate

this change in name.

This change to 40 CFR Part 261,

Appendix IX will be effective February

20, 1997. The Hazardous and Solid

Waste Amendments of 1984 amended

section 3010 of RCRA to allow rules to

become effective in less than six months

when the regulated community does not

need the six-month period to come into

compliance. As described above,

Alumnitec will continue to meet all

conditions of United Technologies

Automotive’s exclusion. Therefore, a

six-month delay in the effective date is

not necessary in this case. This provides

a basis for making this amendment

effective immediately upon publication

under the Administrative Procedures

Act, pursuant to 5 U.S.C. 5531(d).

List of Subjects in 40 CFR Part 261

Environmental protection, Hazardous

waste, Recycling, Reporting and

recordkeeping requirements.

Dated: January 21, 1997.

Jo Lynn Traub,

Acting Regional Administrator, Region 5.

For the reasons set out in the

preamble, 40 CFR part 261 is to be

amended as follows:

PART 261—IDENTIFICATION AND

LISTING OF HAZARDOUS WASTE

1. The authority citation for part 261

continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6921,

6922, 6924(y) and 6938.

2. 40 CFR Part 261, Appendix IX,

Table 1, is amended by removing the

entry for ‘‘United Technologies

Automotive, Inc.’’ and by adding in

alphabetical order the entry for

‘‘Alumnitec, Inc.’’ to read as follows:

Appendix IX to Part 261—Wastes

Excluded Under §§ 260.20 and 260.22

TABLE 1.—WASTES EXCLUDED FROM NON-SPECIFIC SOURCES

Facility Address Waste description

* * * * * * *

Alumnitec, Inc. (formerly Profile Extrusion Co., formerly

United Technologies Automotive, Inc.).

Jeffersonville, IN ................. Dewatered wastewater treatment sludge (EPA Hazardous Waste No. F019) generated from the chemical

conversion of aluminum after April 29, 1986.

* * * * * * *