[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,     
                                 <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="036962606c61702d746a6f6f6a626e436673626e626a">[email protected]</a>   Arlington, VA  
                                 l.epa.gov.                             
Joanne Miller (PM 23),........  Rm. 237, CM #2, 703-    Do.             
                                 305-6224, e-mail:                      
                                 <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="45282c292920376b2f2a242b2b200520352428242c29">[email protected]</a>                  
                                 .epa.gov.                              
------------------------------------------------------------------------

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:
    <a href="/cdn-cgi/l/email-protection#fd928d8dd099929e969889bd988d9c909c9491d3988d9cd39a928b"><span class="__cf_email__" data-cfemail="204f50500d444f434b4554604550414d41494c0e4550410e474f56">[email protected]</span></a>


    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 
LD<INF>50</INF> 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 
<gr-thn-eq>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 ECO<INF>2</INF>FUME 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 
ECO<INF>2</INF>FUME. This petition is associated with a request for an 
experimental use permit for a non-crop destruct program for 
ECO<INF>2</INF>FUMETM. This pesticide contains 2% Phosphine 
(PH<INF>3</INF>) and 98% Carbon Dioxide (CO<INF>2</INF>) 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 ECO<INF>2</INF>FUMETM: 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. CO<INF>2</INF> is exempt from tolerances (40 CFR 180.1049), and 
hence no tolerance is required for this active ingredient 
ECO<INF>2</INF>FUMETM 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 ECO<INF>2</INF>FUMETM 
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 
ECO<INF>2</INF>FUMETM 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. ECO<INF>2</INF>FUMETM mixture: Phosphine 
2% and CO<INF>2</INF> 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 
ECO<INF>2</INF>FUMETM 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-<SUP>4</SUP> poise
      2.6     Flammability hazard
    ECO<INF>2</INF>FUMETM consists of mixture of 2.6% by volume (2% by 
weight) of phosphine in carbon dioxide and is non-flammable.
    3. Specifications formulation. ECO<INF>2</INF>FUMETM [20g/kg 
PH<INF>3</INF> in CO<INF>2</INF>] Chemically Pure Grade Phosphine of 
typical purity (990g/kg) sufficient to give...20g/kg Carbon Dioxide - 
balance to give...980g/kg - Phosphine: [PH<INF>3</INF>]; CAS registry 
no. 7803-51-2, molecular weight 34.00 - Carbon Dioxide: 
[CO<INF>2</INF>]; CAS registry no. 124-38-9, molecular weight 44.01

Use Pattern

    1. Fields of use. ECO<INF>2</INF>FUMETM 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 
ECO<INF>2</INF>FUMETM (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. ECO<INF>2</INF>FUMETM 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 
ECO<INF>2</INF>FUMETM gas mixture is ready for use as per label 
directions.
    ii. General instructions. Only experienced and properly instructed 
persons should use ECO<INF>2</INF>FUMETM. While in the container 
ECO<INF>2</INF>FUMETM 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 ECO<INF>2</INF>FUMETM in well-sealed storages.
    DO only apply ECO<INF>2</INF>FUMETM with the high-pressure kit (CIG 
Kit 416600)
    DO use extreme caution when handling ECO<INF>2</INF>FUMETM.
    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. ECO<INF>2</INF>FUME, 
the non-flammable gaseous phosphine mixture, is dispensed via gas-tight 
distribution systems. The proposed use of non-flammable 
ECO<INF>2</INF>FUME 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 
ECO<INF>2</INF>FUME 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 ECO<INF>2</INF>FUMETM 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 PH<INF>3</INF> 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 PH<INF>3</INF> 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 PH<INF>3</INF> 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 PH<INF>3</INF> 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

    ECO<INF>2</INF>FUMETM is a mixture of two well known fumigants 
PH<INF>3</INF> and CO<INF>2</INF>. Tolerances have already been 
established for PH<INF>3</INF> 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 PH<INF>3</INF> 
generated from metal phosphides. CO<INF>2</INF> is exempt from 
tolerance. Use of ECO<INF>2</INF>FUMETM results in approximately 75% 
less PH<INF>3</INF> being used for fumigation as compared to 
PH<INF>3</INF> from metal phosphides ECO<INF>2</INF>FUMETM 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


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