Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices 48837

TABLE 2. — REGISTRANTS REQUESTING AMENDMENTS TO DELETE USES IN CERTAIN PESTICIDE REGISTRATIONS

Company No. Company Name and Address

003125 Bayer Corporation, 8400 Hawthorne Road, P.O. Box 4913, Kansas City, MO 64120.

004816 AgrEvo Environment Health, 95 Chestnut Ridge Road, Montvale, NJ 07645.

059639 Valent U.S.A. Corporation, 1333 N. California Blvd., P.O. Box 8025, Suite 600, Walnut Creek, CA 94596.

III. Existing Stocks Provisions

The Agency has authorized registrants

to sell or distribute product under the

previously approved labeling for a

period of 18 months after approval of

the revision, unless other restrictions

have been imposed, as in special review

actions.

List of Subjects

Environmental protection, Pesticides

and pests, Product registrations.

Dated: September 4, 1997.

Linda A. Travers,

Director, Information Resources Services

Division, Office of Pesticide Programs.

[FR Doc. 97–24695 Filed 9–16–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–762; FRL–5741–1]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–762, must be

received on or before October 17, 1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7506C),

Information Resources and Services

Division, Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

should be submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

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. All written

comments will be available for public

inspection in Rm. 1132 at the address

given above, from 8:30 a.m. to 4 p.m.,

Monday through Friday, excluding legal

holidays.

FOR FURTHER INFORMATION CONTACT: The

product manager listed in the table

below:

Product Manager Office location/telephone number Address

William Jacobs, Acting

(PM 14),.

Rm. 219, CM #2, 703–305–6406, e-mail: jacobs.william@epamail.epa.gov. 1921 Jefferson Davis Hwy, Arlington, VA

Joanne Miller (PM 23), .. Rm. 237, CM #2, 703–305–6224, e-mail: miller.joanne@epamail.epa.gov. Do.

SUPPLEMENTARY INFORMATION: EPA has

received pesticide petitions as follows

proposing the establishment and/or

amendment of regulations for residues

of certain pesticide chemicals in or on

various food commodities under section

408 of the Federal Food, Drug, and

Comestic Act (FFDCA), 21 U.S.C. 346a.

EPA has determined that these petitions

contain data or information regarding

the elements set forth in section

408(d)(2); however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data supports granting of the

petition. Additional data may be needed

before EPA rules on the petition.

The official record for this notice of

filing, as well as the public version, has

been established for this notice of filing

under docket control number [PF–762]

(including comments and data

submitted electronically as described

below). 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 official

record is located at the address in

‘‘ADDRESSES’’ at the beginning of this

document.

Electronic comments can 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. Comment and data will

also be accepted on disks in

Wordperfect 5.1 file format or ASCII file

format. All comments and data in

electronic form must be identified by

the docket number [PF–762] and

appropriate petition number. Electronic

comments on this notice may be filed

online at many Federal Depository

Libraries.

List of Subjects

Environmental protection,

Agricultural commodities, Food

additives, Feed additives, Pesticides and

pests, Reporting and recordkeeping

requirements.
48838 Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices

Dated: September 2, 1997.

James Jones,

Acting Director, Registration Division, Office

of Pesticide Programs.

Summaries of Petitions

Petitioner summaries of the pesticide

petitions are printed below as required

by section 408(d)(3) of the FFDCA. The

summaries of the petitions were

prepared by the petitioners and

represent the views of the petitioners.

EPA is publishing the petition

summaries verbatim without editing

them in any way. The petition summary

announces the availability of a

description of the analytical methods

available to EPA for the detection and

measurement of the pesticide chemical

residues or an explanation of why no

such method is needed.

1. AgrEvo USA Company

PP 9F3714 and 3F4182

EPA has received two pesticide

petitions (PP 9F3714 and 3F4182),

requests from AgrEvo USA Company,

Wilmington, DE 19808, proposing

pursuant to section 408(d) of the Federal

Food, Drug and Cosmetic Act, 21 U.S.C.

346a(d), to amend 40 CFR 180.430(b) by

changing the time-limited tolerances to

permanent tolerances; and by

establishing a regulation to permit

residues of fenoxaprop-ethyl and its

metabolites 2-[4-[(6-chloro-benzolyloxy)

phenoxy] propanoic acid and 6-chloro2,3-dihydrobenzoxazol-2-one in or on

the raw agricultural commodities: barley

grain at 0.05 part per million (ppm) and

barley straw at 0.10 ppm. The proposed

analytical method involves

homogenization, filtration, partition and

cleanup with analysis by gas

chromatography using halogen-selective

electron capture detection. EPA has

determined that these petitions contains

data or information regarding the

elements set forth in section 408(d)(2) of

the FFDCA; however, EPA has not fully

evaluated the sufficiency of the

submitted data at this time or whether

the data supports granting of these

petitions. Additional data may be

needed before EPA rules on these

petitions.

A. Residue Chemistry

1. Plant metabolism. The nature of the

residue of this pesticide is adequately

understood. This was demonstrated in

metabolism studies in plants (cotton,

rice, soybeans and wheat) and livestock

(goat and hen) using both chlorophenyllabeled and dioxyphenyl-labeled test

material. Fenoxaprop-ethyl degrades

rapidly via ester hydrolysis to

fenoxaprop free acid, which is the

principal observed metabolite.

Subsequent cleavage of the phenoxy

linkage of this matabolite produces the

benzoxazolone metabolite.

2. Analytical method. An adequate

analytical method is available for

enforcement purposes. This method

accounts for combined residues of

fenoxaprop-ethyl and its metabolites,

fenoxaprop free acid and 6-chloro-2,3-

dihydrobenzoxazol-2-one. An acid

hydrolysis/extraction procedure is used

to liberate and/or cleave the residue to

the common benzoxazolone moiety.

After clean-up and derivatization, the

residues are determined by gas

chromatography using a halogenselective electron capture detector. The

residues are ultimately expressed as

fenoxaprop-ethyl equivalents. The

analytical method has passed the

independent laboratory validation

according to PR Notice 88–5, as well as

US EPA laboratory validation, and has

been approved for regulatory

enforcement purposes. The method is

published in the Pesticide Analytical

Manual (PAM II).

3. Magnitude of residues. Extensive

field residue trials have been conducted

with fenoxaprop-ethyl on barley and

wheat throughout the major cerealgrowing regions of the United States.

Applications at the maximum use rate

resulted in no detectable residues of

fenoxaprop-ethyl in or on the raw

agricultural commodities barley and

wheat (grain, straw). Likewise, there

were no detectable residues in the

processed commodities (flour and bran)

in samples obtained from processing

studies on barley and wheat using

exaggerated application rates. EPA

therefore established temporary

tolerances based on the Limits of

Quantification (LOQ) of 0.05 ppm for

fenoxaprop-ethyl and its metabolites on

barley grain, and 0.10 ppm on barley

straw, as well as time-limited tolerances

of 0.05 ppm on wheat grain, and 0.5

ppm on wheat straw. In addition, timelimited tolerances for the following

commodities were established (55 FR

50393, December 6, 1990): cattle fat,

meat, mbyp at 0.05 ppm; goat fat, meat,

mbyp at 0.05 ppm; hog fat, meat, mbyp

at 0.05 ppm; horse fat, meat, mbyp at

0.05 ppm; sheep fat, meat, mbyp at 0.05

ppm; and milk at 0.02 ppm.

B. Toxicological Profile

The toxicology of fenoxaprop-ethyl

has been thoroughly evaluated by EPA

as part of previous regulatory actions.

These studies, that were conducted with

the racemate, are considered to be valid,

reliable and adequate for the purposes

of evaluating potential health risks and

for establishing tolerances for both the

racemic and isomer-enriched forms of

the active ingredient. These studies

include the following:

1. Acute toxicity. Acute toxicity

studies supporting an EPA Toxicity

Category III classification (rat oral and

dermal LD50 values of 2,397 mg/kg/day

and >2,000 mg/kg/day, respectively).

2. Genotoxicity. A battery of

genotoxicity studies, none of which

indicated any genotoxic potential. The

studies submitted included: in vitro

human lymphocyte chromosomal

aberration, mouse micronucleus, in vitro

unscheduled DNA synthesis, Ames

Salmonella bacterial point mutation and

yeast DNA repair assays.

3. Reproductive and developmental

toxicity. Two 2-generation rat

reproduction studies with no evidence

of reproductive effects in either study.

In the first study, the EPA concluded

that 30 ppm was the NOEL for parental

toxicity but that, because of kidney and

liver weight changes, no NOEL was

determined for the offspring. In a

second study at the same dose levels,

the EPA concluded that 5 ppm (0.4 mg/

kg/day) was the NOEL for both adults

and offspring.

4. Subchronic toxicity. A number of

developmental toxicity studies in rats,

rabbits, mice and monkeys. The

maternal and developmental NOEL’s in

these studies were similar, and ranged

from 10 to ≥50 mg/kg/day. In rabbits,

the maternal and developmental NOEL’s

were considered to be 12.5 and 50 mg/

kg/day, respectively. In one of the rat

studies, the developmental NOEL (10

mg/kg/day) was lower than the maternal

NOEL (32 mg/kg/kg). However, in a

second rat study conducted using the

same dose levels, the maternal and

developmental NOEL were both 32 mg/

kg/day. In the monkey study, no clear

developmental effects were noted even

at a dose level (50 mg/kg/day) which

was lethal to 45% of the monkeys. Thus,

the overall weight of evidence indicates

the lack of any specific developmental

effect and no increased sensitivity to the

embryo or fetus.

5. Chronic toxicity. A 2–year mouse

oncogenicity study with no indication

of carcinogenicity at dose levels up to

40 ppm (6 mg/kg/day), the highest dose

tested. However, this high-dose level

did not meet the EPA’s criteria for a

Maximum Tolerated Dose (MTD); thus a

new study was conducted. In this study,

an increased incidence of various nonneoplastic liver lesions as well as an

increased incidence of primarily benign

liver tumors were noted at 115 and 320

ppm. Although this study has not yet

been reviewed by the EPA Cancer Peer

Review Committee, AgrEvo believes that

both of these dose levels exceeded the
Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices 48839

MTD. No neoplastic or non-neoplastic

lesions were noted at 40 ppm (6.2 mg/

kg/day), which was considered the

NOEL.

6. Animal metabolism. Absorption,

distribution, metabolism and excretion

studies in several species indicate that

fenoxaprop-ethyl is well absorbed after

oral administration and relatively

rapidly metabolized and excreted. No

evidence of bioaccumulation was noted

after repeated dosing.

7. Metabolite toxicology. All

significant metabolites have been

identified and tested as part of the

overall toxicology requirements for the

parent compound, and expressed in the

existing and /or pending tolerances.

C. Aggregate Exposure

1. Dietary exposure. The dietary

exposure is discussed below under the

topics food and drinking water.

(a) Food. A dietary exposure

assessment was performed for

fenoxaprop-ethyl using the Exposure 1

software system (TAS, Inc.) and the

1977–78 USDA consumption data. The

first assessment calculated the

Theoretical Maximum Residue

Contribution (TMRC). The TMRC is a

‘‘worst-case’’ estimate that assumes that

100% of the listed crops have been

treated and that all commodities

including meat and milk contain

residues at the tolerance level. A more

realistic exposure assessment was also

conducted using estimates of percent

crop treated and anticipated residue

levels.

(b) Drinking water. The potential for

fenoxaprop-ethyl to leach into

groundwater was assessed in various

laboratory studies as well as in

terrestrial field dissipation studies

conducted in several locations and soil

types. The degradation of fenoxapropethyl and its main metabolites occurs

rapidly in both laboratory and the field,

with half-lives in soil ranging from 9 to

14 days. No evidence of leaching of

parent or degradation products was

observed. The compound is immobile

and the potential to leach into

groundwater is negligible. Fenoxapropethyl adsorbs strongly to soil (Koc =

12,500 to 18,880) and has a low water

solubility (0.9 mg/l at pH 7), which

results in minimal field runoff and a

low potential for contamination of

surface water. Together, these data

indicate that residues of fenoxapropethyl are not expected in drinking

water. Therefore, the contribution of any

such residues to the total dietary intake

of fenoxaprop-ethyl will be negligible.

There is no established Maximum

Contaminant Level (MCL) or Health

Advisory Level (HAL) for residues of

fenoxaprop-ethyl in drinking water.

2. Non-dietary exposure. Fenoxapropethyl is registered for selective

postemergence grass control in turfgrass

including sod farms, commercial and

residential turf and ornamentals. All of

these applications are done by

professional applicators; there are no

homeowner uses. Thus, the only nonoccupational exposure would be from

dermal contact during reentry to treated

areas. Insufficient information is

currently available to conduct a reliable

assessment of potential exposure from

reentry on turf. Studies to quantitate

this exposure are now being conducted

by the Outdoor Residential Exposure

Task Force (ORETF). However, AgrEvo

believes that such exposures are

relatively low and, based on the

available toxicology data, are unlikely to

pose a significant risk to human health.

D. Cumulative Effects

Fenoxaprop-ethyl is a member of the

aryloxy phenoxy-propionate class of

herbicides. It is an inhibitor of fatty acid

biosynthesis in both plants and animals,

and induces peroxisome proliferation in

rodents. Like other peroxisome

proliferators, it induces liver tumors in

mice at exaggerated dose levels.

However, the precise mechanism by

which peroxisome proliferators induce

liver tumors in rodents has not yet been

determined. In addition, humans are

considered to be far less sensitive to the

peroxisome proliferative effects of these

compounds than are rodents.

Furthermore, the methodology to

evaluate the potential aggregate risks

from multiple chemicals with a

common mechanism of action has not

yet been defined. Therefore, only

exposure from fenoxaprop-ethyl is being

addressed at this time.

E. Safety Determination

1. U.S. population. The toxicity and

residue data bases for fenoxaprop-ethyl

are considered to be valid, reliable and

essentially complete. The EPA

Carcinogenicity Peer Review Committee

has not yet reviewed the results of the

recently completed mouse oncogenicity

study in which liver tumors were noted.

However, AgrEvo believes that

quantitative oncogenic risk assessment

is inappropriate for the following

reasons:

(a) Evidence of oncogenicity was

limited to a single site (liver) in a single

species (mouse), and occurred only at

dose levels that were considered by

AgrEvo to have exceeded the MTD.

(b) No evidence of genotoxicity has

been observed.

(c) Fenoxaprop-ethyl is known to be

a peroxisome proliferator and the

tumors were noted only in conjunction

with significant non-neoplastic

hepatotoxicity.

(d) The relevance of mouse liver

tumors, particularly those caused by

hypolipidemic peroxisomal

proliferators, to human risk assessment

is considered minimal, especially at the

extremely low dose levels to which

humans would typically be exposed.

Thus, a standard margin of safety

(exposure) approach is considered

appropriate to assess the potential for

fenoxaprop-ethyl to produce both

oncogenic and non-oncogenic effects.

The EPA has previously adopted an RfD

value of 0.0025 mg/kg/day for

fenoxaprop-ethyl. This value was based

on the Agency’s conclusion of a 5 ppm

NOEL for both parents and offspring in

the second multigeneration rat

reproduction study and a 100–fold

safety (uncertainty) factor. However, in

converting the NOEL dietary

concentration of 5 ppm to test material

intake (mg/kg/day), the EPA used a

standard conversion factor for food

consumption in adult rats rather than

study specific results. Based on actual

food consumption values, the NOEL for

this study was really equivalent to an

average dose level of approximately 0.4

mg/kg/day for the adults and

approximately 1 mg/kg/day for the

offspring. Furthermore, AgrEvo believes

that the results of the original rat

reproduction study and the 2-year rat

chronic toxicity study support the

conclusion that the NOEL for adult

toxicity in the second rat reproduction

study was not 5 ppm but 30 ppm (2.5

mg/kg/day). Therefore, AgrEvo believes

that the RfD should have been based on

the NOEL of approximately 0.9 mg/kg/

day from the 2–year dog study or, since

rats are the most sensitive species to

fenoxaprop-ethyl, the NOEL of

approximately 1 mg/kg/day for offspring

in the second reproduction study. This

would result in an RfD of 0.01 mg/kg/

day, not 0.0025 mg/kg/day.

Nevertheless, for this risk assessment,

AgrEvo used the RfD value of 0.0025

mg/kg/day assigned by EPA.

The aggregate exposure of the general

population to fenoxaprop-ethyl from the

established and pending tolerances

utilizes about 17% of the RfD using

worst-case assumptions (100% crop

treated and tolerance level residues for

all commodities, including livestock).

Assuming more realistic estimates of

percent crop treated and anticipated

residues, only 2% of the RfD was

utilized. The RfD represents the level at

or below which daily aggregate

exposure over a lifetime would not pose
48840 Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices

a significant risk to human health. There

is generally no concern for exposures

which utilize less than 100% of the RfD,

particularly when conservative

assumptions are utilized for the

calculations. Therefore, there is a

reasonable certainty that no harm will

result to the general population from

aggregate risk to residues of fenoxapropethyl.

2. Infants and children. Data from rat

and rabbit developmental toxicity

studies and rat multigeneration

reproduction studies are generally used

to assess the potential for increased

sensitivity of infants and children. The

developmental toxicity studies are

designed to evaluate adverse effects on

the developing organism resulting from

potential exposure during prenatal

development. Reproduction studies

provide information relating to

reproductive and other effects on adults

and offspring from potential prenatal

and postnatal exposure to the pesticide.

The overall weight of the evidence

from the developmental toxicity studies

and multigeneration rat reproduction

studies indicates that the toxicity of

fenoxaprop-ethyl to infants and children

is comparable to its toxicity to adults.

No reproductive effects were noted in

either of the two multigeneration

studies. Developmental effects were

noted in rats and rabbits, but generally

only at dose levels that induced

maternal toxicity. No clear

developmental effects were noted in

monkeys even at dose levels that were

lethal to 45% of the mothers. In general,

the maternal and developmental NOEL’s

in the various studies were comparable

and ranged from 10 to 50 mg/kg/day.

FFDCA section 408 provides that EPA

may apply an additional safety factor for

infants and children to account for preand post-natal toxicity and the

completeness of the data base. However,

the toxicology data base for fenoxapropethyl is complete according to existing

Agency data requirements and does not

indicate any developmental or

reproductive concerns. Furthermore, the

existing RfD of 0.0025 mg/kg/day

already provides an approximately 400–

fold safety factor relative to the NOEL (1

mg/kg/day) for offspring in the

multigeneration rat reproduction study

and a 4,000–fold safety factor relative to

the lowest developmental NOEL (10 mg/

kg/day) observed in the developmental

toxicity studies. Thus, the existing RfD

is considered appropriate for assessing

potential risks to infants and children

and an additional uncertainty factor is

not warranted.

Using worst-case assumptions (100%

crop treated and tolerance level residues

for all commodities, including

livestock), aggregate exposure to

residues of fenoxaprop-ethyl is expected

to utilize about 65% of the RfD in nonnursing infants (less than 1–year old),

42% of the RfD in children aged 1 to 6–

years old, 28% of the RfD in children

aged 7 to 12–years old, and 16% of the

RfD in nursing infants. Using more

realistic estimates of percent crop

treated and anticipated residues, the

percent of RfD utilized would be no

more than 8% (non-nursing infants less

than 1–year old) for these population

subgroups. Therefore, there is a

reasonable certainty that no harm will

result to infants or children from

aggregate exposure to fenoxaprop-ethyl

residues.

F. International Tolerances

As no residues were detected (LOQ <

0.05 ppm) in wheat and barley grain,

there are no Codex, Canadian or

Mexican Maximum Residue Limits

(MRLs) for residues of fenoxaprop-ethyl

in these commodities. Therefore,

international harmonization is not an

issue for these tolerances. (PM 23)

2. BOC GASES

PP 7F4809

EPA has received a pesticide petition

(PP 7F4809) from BOC GASES c/o the

Sloane Group, 52 Amogerone Crossway,

Greenwich, CT, 06830. The Petition

proposes, pursuant to section 408 of the

Federal Food, Drug, and, Cosmetic Act

(FFDCA), 21 U.S.C 346a to establish a

temporary tolerance for the use of

ECO2FUME in accordance to 40 CFR

180.225, 180.375, 185.200, 185.3800. As

required by section 408(d) of FFDCA, as

recently amended by the Food Quality

Protection Act (FQPA), BOC Gases

included in the petition a summary of

the petition and authorization for the

summary to be published in the Federal

Register in a notice of receipt of the

petition. The summary represents the

view of BOC GASES, the EPA is in the

process of evaluating the petition. As

required by section 408(d)(3), EPA is

including the summary as a part of this

notice of filing. EPA may have minor

edits to the summary for purposes of

clarity.

This petition is submitted by BOC

GASES, under section 408 of the

Federal Food Drug and Cosmetic Act (21

U.S.C. 346a), as most recently amended

by the FQPA. This submission proposes

a temporary tolerance for purposes of an

experimental use permit for the

fumigant ECO2FUME. This petition is

associated with a request for an

experimental use permit for a non-crop

destruct program for ECO2FUMETM.

This pesticide contains 2% Phosphine

(PH3) and 98% Carbon Dioxide (CO2) by

weight as a cylinderized gaseous

mixture.

This Petition requests that the

temporary tolerance mirror 40 CFR part

180 and 185 and thereby establishing a

temporary tolerance for the following

raw agricultural commodities from the

post harvest treatment with

ECO2FUMETM: Almonds, Avocados,

Bananas, Barley, Beans, (cocoa), Beans,

(coffee), Brazil nuts, Cabbage, (Chinese),

Cashews, Citrus citron, Cocoa beans,

Coffee beans, Corn, Corn pop,

Cottonseed, Dates, Eggplants, Endive

(escarole), Filberts, Grapefruit,

Kumquats, Lemons, Lettuce, Limes,

Mangos, Millet, Mushrooms, Nuts,

(Brazil), Nuts, (Pistachios), Oats,

Oranges, Papayas, Peanuts, Pecans,

Peppers, Persimmons, Pimentos,

Pistachio nuts, Plantains, Rice, Rye,

Safflower seed, Salsify tops, Sesame

seed, Sorghum, Soybeans, Sunflower

seed, Sweet potatoes, Tangelos,

Tangerines, Tomatoes, Vegetables, seed

and pod (except soybeans), Walnuts,

and Wheat Data pertaining to the

product chemistry, use patterns, safety,

residues, removing residues, detecting

residues, endocrine effects and exposure

to infants and children, have been

submitted.

This petition is based on the

following facts:

1. CO2 is exempt from tolerances (40

CFR 180.1049), and hence no tolerance

is required for this active ingredient

ECO2FUMETM contains a very low

percentage of phosphine.

2. A tolerance has already been

established for phosphine generated

from aluminum phosphide and

magnesium phosphide.

3. Quantities of phosphine utilized

with the ECO2FUMETM process are

significantly lower than the quantities

generated in the use of the metal

phosphides.

4. Literature data show phosphine

residues levels from the use of

ECO2FUMETM are less than 0,001 ppm.

5. Unlike metal phosphides, the

application method is controlled and

precise with predictable residue results.

The petitioners agree that this summary

or any information it contains may be

published as a part of the notice of filing

of the petition and as part of a proposed

or final regulation issued under Sec. 408

of the FFDCA.

A. Product Chemistry Data

1. Analytical methodology.

ECO2FUMETM mixture: Phosphine 2%

and CO2 98%. Analysis of gases and gas

mixtures are conveniently and

accurately carried out using gas

chromatography. The GC/MS technique
Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices 48841

developed by AGAL, Pymble for

analyzing trace contaminants,

particularly other derivatives of

phosphine in the ECO2FUMETM

mixture is detailed in the submission.

2. Chemical and physical properties

of end use product. All BOC produced

and purchased gases are the subject to

a Quality Control program. In addition

to works instructions and works tests

representative, samples of individual

batch are verified for purity by

analytical chemists in BOC’s

laboratories.

2.1 Color - colorless gas

2.2 Odor - Odor of rotting fish

above 2 ppm phosphine (‘‘carbide’’

odor)

2.3 Bulk Density - Not

applicable

2.4 Density - Specific Gravity is

1.5. (Air=1) i.e. heavier than air

2.5 Viscosity - 1.4 x 10-4 poise

2.6 Flammability hazard

ECO2FUMETM consists of mixture of

2.6% by volume (2% by weight) of

phosphine in carbon dioxide and is

non-flammable.

3. Specifications formulation.

ECO2FUMETM [20g/kg PH3 in CO2]

Chemically Pure Grade Phosphine of

typical purity (990g/kg) sufficient to

give...20g/kg Carbon Dioxide - balance

to give...980g/kg - Phosphine: [PH3];

CAS registry no. 7803-51-2, molecular

weight 34.00 - Carbon Dioxide: [CO2];

CAS registry no. 124-38-9, molecular

weight 44.01

Use Pattern

1. Fields of use. ECO2FUMETM is

used for the control of eggs, larvae,

pupae, and/or adults of the following

stored product pests: Angoumois grain

moth, bean weevil, cadelle, cereal leaf

beetle, cigarette beetle, coffee bean

weevil, confused flour beetle, cowpea

beetle, dried fruit beetles, flat grain

beetles, fruit flies, granary weevil,

Indian meal moth, Khapra beetle, larger

wax moth, lesser grain borer, lesser wax

moth, maize weevil, Mediterrarean flour

moth, merchant grain beetle, mottled

grain moth, pink bollworm, psocids,

raisin moth, rediegged ham beetle, rice

weevil, rust-red flour beetle, sawtoothed

grain beetle, skin and hide beetles,

spider beetles, stored product mites,

tobacco moth, tropical warehouse moth,

warehousez beetle, yellow mealworm.

Treatment for the above pests at the

specified rates will kill any cockroaches,

rats and mice present.

2. Use level of product–—i. Dosage.

Seventy-five g/m3 of ECO2FUMETM

(equivalent to 1.5 g/m3 of phosphine) in

well-sealed storages.

ii. Minimum exposure. Temperatures

above 25°C.. 7 days, temperatures above

150-25°C..10 days. ECO2FUMETM

should be used in storages in which the

standard of gastightness is consistent

with a decay of an excess external

pressure from 500 Pa (2’’ w.g.) to 250 Pa

(1’’ w.g.) in not less than 5 minutes in

filled storages.

3. Situations—i. Foods. Raw cereal

grains (such as barley, maize, millets,

oats, rice, rye, sorghum, wheat) and

other food commodities such as animal

feeds, breakfast cereals, brewing malt,

chocolate products, cocoa beans, coffee

beans, dried fruits, dried vegetables,

flour, milled cereal products, nuts,

oilseeds, other dried foods, seeds,

soybeans, tapioca, eta.

ii. Tobacco and tobacco products.

iii. Timber and cane products;

Building and structures.

4. Limitations—i. Directions for use.—

Mixing. The ECO2FUMETM gas mixture

is ready for use as per label directions.

ii. General instructions. Only

experienced and properly instructed

persons should use ECO2FUMETM.

While in the container ECO2FUMETM is

a liquid mixture under pressure, which

turns to gas when, released. The gas

must be confined along with

commodities being fumigated under a

gas-proof cover or in a container of

structure that is airtight.

iii. Restraints.

DO only apply ECO2FUMETM in

well-sealed storages.

DO only apply ECO2FUMETM with

the high-pressure kit (CIG Kit 416600)

DO use extreme caution when

handling ECO2FUMETM.

DO perform fumigation and aeration

in accordance with label.

DO show prominently warning signs:

‘‘DANGER---POISON GAS---KEEP

AWAY’’

DO NOT enter fumigation area and

keep animals, children, and

unauthorized persons away until the

area is shown to be free from phosphine

as indicated by a gas-measuring device.

5. Withholding periods. A period of

three days after completion of

ventilation before using treated

commodities for human consumption or

for stock food. Treated commodities

may be safely transported after

completion of the recommended

ventilation period.

6. Protection of livestock, wildlife and

others. As a general precautionary

measure, the following advice will

appear on the label. Store in a cool well

ventilated, locked area out of reach of

children or unqualified persons and

away from habitation. Cylinder always

remains the property of BOC, and

should be returned for refilling.

C. Toxicology of End Use Product and

Technical Active Ingredient

Toxicology summary. Toxicological

evaluation of fumigation usage of

phosphine has been based upon

phosphine gas. ECO2FUME, the nonflammable gaseous phosphine mixture,

is dispensed via gas-tight distribution

systems. The proposed use of nonflammable ECO2FUME offers improved

operator safety, accurate controllable

dosage and the elimination of fire

hazard. Toxicity study results show

phosphine to be a highly toxic

inhalation poison. Oral toxicity while

not relevant for gaseous phosphine

(although a concern with metallic

phosphides) has been cleared in longterm feeding studies. Dermal toxicity is

not an anticipated concern, as

phosphine gas is not absorbed through

the skin. Eye irritation may be a concern

in acute exposure, but all operators will

be required to wear protective eyewear.

Acute animal studies show that albino

rats can tolerate 5 ppm over several

months but 10 ppm with continual

exposure causes mortality. Single dose

studies indicate 40 ppm for 6 hours

have 100% mortality. Long-term animal

studies show rats have no toxic effects

when fed on a diet of metallic

phosphide or on phosphine-fumigated

diets. As no specific antidote is known,

symptomatic treatment is required.

Chronic exposure affects the visual,

motor and gastro-intestinal tract. Longterm exposure to low concentration can

cause anemia and bronchitis. Organs

with the greatest oxygen requirement

appear to be especially sensitive to

damage. The NOEL for ECO2FUME is

2mg/kgbw/day and ADI is 0.02mg/

kgbw/day.

The 1986 ACGIH has recommended a

Threshold Limit Value (TLV-TWA) of

0.3 ppm (0.4 mg/m3) with a STEL of 1

ppm for phosphine. Using a tidal

volume of 0.5 litters, 12 breaths/min, a

body weight of 80kg and the TLV-TWA

of 0.4mg/m3 gives a NOEL of 0.04mg/

kgbw/day for phosphine.

D. Residue Testing

1. Summary. Analytical techniques

for the determination of phosphine

residues in a range of stored food

studies with a limit of detection better

than 0.0001mg/kg are available.

Analytical methods have been used to

obtain data on the amount of phosphine

which remains in these commodities

after treatment with ECO2FUMETM at

typical and exaggerated dosage levels

and on its persistence during storage.

Results show that residues fall quickly

to below internationally recommended

levels. Maximum residue limits for
48842 Federal Register / Vol. 62, No. 180 / Wednesday, September 17, 1997 / Notices

cereal grains are 0.1 mg/kg and is

0.01mg/kg for processed foods after

treatment with PH3 generated from

metal phosphides. This corresponds to

the levels set both by Environmental

Protection Agency/the NH & MRC of

Australia and the Codex Alimentarius

Commission of the WHO/FAO.

2. Analytical methodology. The

maximum residue limit recommended

by the Codex Alimentarius Commission

of the WHO/FAO for phosphine in raw

cereals is 0.1mg/kg and in milled cereals

and a range of foodstuffs including nuts

it is 0.01mg/kg. An improved method

for the determination of phosphine

residues in a range of stored foodstuffs

with a limit of detection better than

0.0001mg/kg is described by K.A.

Scudamore and G.Goodship (Ref:

‘‘Determination of Phosphine Residues

in Fumigated Cereals and other

Foodstuffs.’’ Pestic. Sci. 1986, 37; 385-

395). The method has been used to

obtain data on the amount of phosphine,

which remains in these commodities

after treatment at typical dosage levels

and on its persistence during storage.

Results show that in cereal grains and

nuts residues fall quickly to below.

Internationally recommended levels

although ultra trace amounts (less than

0.001 mg/kg) of phosphine could be

detected several months after treatment

in all the commodities examined.

3. Crop residue data. While

phosphine is not applied to growing

plants or crops it is a well-established

fumigant of cereal grain and stored

products.

4. Fate of residues. The possible

reactions of absorbed phosphine within

the commodity matrics to form

inorganic phosphorous compounds

have been detailed. In warm-blooded

animals, phosphorous acid and

phosphoric acid are formed or else

phosphate. The volatile nature of

phosphine (boiling point minus 87°C)

and its limited solubility ensures that

any phosphine absorbed in a foodstuff

during treatment would be negligible

and rapidly lost. Residue of phosphine

held for any length of time is less than

0.001 mg/kg i.e., 0.001 ppm. Phosphoric

acid has many uses including an

acidulate and flavor in beverages of the

soft drink type.

5. Maximum residue limits— i.

Overseas. The maximum residue limit

recommended by the Codex

Alimentarius Commission of the WHO/

FAO for phosphine in raw cereals is 0.1

mg/kg and in milled cereals and a range

of foodstuffs including nuts is 0.01 mg/

kg. (Ref: ‘‘Codex Maximum Limits for

Pesticide Residues’’ Codex Alimentarius

Commission Volume XIII, Rome 1983).

ii. Australia. The 100th session of the

National Health and Medical Research

Council, November 1985 gave the

maximum residue limit in cereal grains

of 0.1 mg/kg; and in flour and other

milled cereal products, breakfast

cereals, dried fruit, dried vegetables, all

other dried foods, spices, nuts, peanuts,

cocoa, beans and honey a limit of 0.01

mg/kg. The maximum residue limit is

set at or about the limit of analytical

determination. If the substance were to

occur at or below this limit it is

considered that no hazard to human

health would occur. (Ref: ‘‘Standard for

Maximum Residue Limits of Pesticides,

Agricultural Chemical, Feed Activities,

Veterinary Medicines and Noxious

Substances in Food’’ Commonwealth

Dept. of Health, Commonwealth of

Australia 1986. ISBN 0644 04688 0).

iii. U.S.A. Tolerances have been

established for commodities fumigated

by the fumigant PH3 generated from

metal phosphides. Maximum residue

limits for cereal grains are 0.1 mg/kg

and is 0.01mg/kg for processed foods

after treatment with PH3 generated from

metal phosphides.

E. Residue Detection and Removal

See Section D Above

F. Endocrine Effects

Phosphine degrades to phosphates

and phosphoric acid or else phosphates,

in warm-blooded animals (Ref: ‘‘The

Agrochemicals Handbook’’, Royal

Society of Chemistry, 1986). It has been

shown that there is no overt toxicity

associates with the residue low levels

(order 0.001 ppm) of phosphine

products, in fact, a major buffering

system of the body utilizes polybasic

phosphates; and phosphoric acid is

used as an acidulate and flavor in

beverages of soft drink type (Ref: The

Merck Index, 9th Edition, 7153).

G. Exposure to Infants and Children

Summary. Commodities fumigated

with PH3 at the recommended dosage

levels leaves very little residue in the

order of 0,001ppm (see part D) Long

term feeding studies showed that

ingestion of PH3 fumigated dirt by the

rat for 2 years does not cause any

marked modification of growth, food

intake, nitrogen balance, body

composition, functional behavior or the

incidence of type of tumors. The

product should however, at all times be

kept out of reach of children or other

uncertified applicators due to acute

inhalation toxicity.

H. Reasonable Grounds

ECO2FUMETM is a mixture of two

well known fumigants PH3 and CO2.

Tolerances have already been

established for PH3 generated from

Aluminum and Magnesium phosphide.

Maximum residue limits for cereal

grains are 0.1 mg/kg and is 0.01mg/kg

for processed foods after treatment with

PH3 generated from metal phosphides.

CO2 is exempt from tolerance. Use of

ECO2FUMETM results in approximately

75% less PH3 being used for fumigation

as compared to PH3 from metal

phosphides ECO2FUMETM has

recorded residue levels of below

0,001ppm. (PM 14)

[FR Doc. 97–24694 Filed 9–16–97; 8:45 am]

BILLING CODE 6560–50–F

ENVIRONMENTAL PROTECTION

AGENCY

[PF–753; FRL–5735–5]

Notice of Filing of Pesticide Petitions

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice.

SUMMARY: This notice announces the

initial filing of pesticide petitions

proposing the establishment of

regulations for residues of certain

pesticide chemicals in or on various

food commodities.

DATES: Comments, identified by the

docket control number PF–753, must be

received on or before October 17, 1997.

ADDRESSES: By mail submit written

comments to: Public Information and

Records Integrity Branch (7506C),

Information Resources and Services

Division, Office of Pesticides Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460. In

person bring comments to: Rm. 1132,

CM #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Comments and data may also be

submitted electronically by following

the instructions under

‘‘SUPPLEMENTARY INFORMATION.’’

No confidential business information

should be submitted through e-mail.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). CBI should not be submitted

through e-mail. Information marked as

CBI will not be disclosed except in

accordance with procedures set forth in

40 CFR part 2. A copy of the comment

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. All written

comments will be available for public