[Federal Register Volume 62, Number 180 (Wednesday, September 17, 1997)]
[Notices]
[Pages 48837-48842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-24694]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-762; FRL-5741-1]
Notice of Filing of Pesticide Petitions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
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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:
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Office location/
Product Manager telephone number Address
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William Jacobs, Acting (PM Rm. 219, CM #2, 703- 1921 Jefferson
14),. 305-6406, e-mail: Davis Hwy,
[email protected] Arlington, VA
l.epa.gov.
Joanne Miller (PM 23),........ Rm. 237, CM #2, 703- Do.
305-6224, e-mail:
[email protected]
.epa.gov.
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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.
[[Page 48838]]
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-chloro-2,3-
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 chlorophenyl-labeled 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 halogen-selective 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 cereal-growing 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, time-limited 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
non-neoplastic 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
[[Page 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 fenoxaprop-ethyl 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. Fenoxaprop-
ethyl 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 fenoxaprop-ethyl 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. Fenoxaprop-ethyl 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 non-occupational 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
[[Page 48840]]
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 fenoxaprop-ethyl.
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 pre- and post-natal
toxicity and the completeness of the data base. However, the toxicology
data base for fenoxaprop-ethyl 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 non-nursing 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="">2FUME 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
[[Page 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 deg.C.. 7 days,
temperatures above 150-25 deg.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 non-flammable gaseous phosphine mixture, is dispensed via gas-tight
distribution systems. The proposed use of non-flammable
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 long-term 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. Long-term 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
[[Page 48842]]
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 deg.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
