[Federal Register Volume 62, Number 242 (Wednesday, December 17, 1997)]
[Notices]
[Pages 66091-66094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-32932]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-785; FRL-5760-5]


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-785], must 
be received on or before January 16, 1998.

ADDRESSES: By mail submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), 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 to: opp-
[email protected]. Follow 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: Amelia M. Acierto, Registrtion 
Division (7505W), Office of Pesticide Programs, U.S. Environmental 
Protection Agency, 401 M Street, S.W., Washington, D.C. 20460. Office 
location, telephone number and e-mail address: Rm. 4W60 4th floor, CS1, 
2800 Crystal Drive, Arlington VA, (703)308-8377, e-mail: 
[email protected].

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-785] (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:

    [email protected]

    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-785] and appropriate petition 
number. Electronic comments on 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.

    Dated: December 4, 1997
Peter Caulkins,
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. Ecolab Inc.

PP 7E4922

    EPA has received a pesticide petition (PP 7E4922) from Ecolab Inc., 
370 N. Wabasha Street, St. Paul, Minnesota 55102, proposing pursuant to 
section 408(d) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 
346a(d), to amend 40 CFR 180.1001(c) to establish an exemption from the 
requirement of a tolerance for the residues of

[[Page 66092]]

hydroxyethylidine diphosphonic acid (HEDP) when used as an inert 
ingredient at levels of 0.9% in pesticide formulations applied to 
agricultural commodities after harvest.
    EPA has determined that the petition 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 the petition. 
Additional data may be needed before EPA rules on the petition.

A. Proposed Use Practices

    HEDP is proposed for use as an inert ingredient in an antimicrobial 
treatment formulation contacting raw agricultural commodities.
    1. Acute toxicity. The acute and chronic toxicity of HEDP have been 
tested extensively. Adverse effects are not expected when used in the 
proposed manner.
    Pure HEDP exhibits low acute oral and dermal toxicity. The oral 
LD50 ranged from 1,340 to 3,130 milligrams/kilogram (mg/kg) 
(Toxicity Category III) and the dermal LD50 ranged from 
7,940 to greater than 10,000 mg/kg (Toxicity Category IV). HEDP is 
moderately irritating to the skin (Toxicity Category III) and is 
corrosive to the eyes (Toxicity Category I).
    2. Genotoxicity. No mutagenic activity was observed in microbial 
assays using five Salmonella strains or in a L5178Y TK mouse lymphoma 
cell point mutation assay, with and without mammalian microsomal 
activation. There are no significant genotoxicity concerns for HEDP.
    3. Reproductive and developmental toxicity. No reports were found 
in the open literature indicating that HEDP caused developmental or 
reproductive effects.
    4. Subchronic toxicity. Subchronic studies were conducted in both 
rats and dogs. In these studies, rats were exposed to HEDP in the diet 
at concentrations up to 30,000 parts per million (ppm) and in dogs up 
to 10,000 ppm. Histopathological evaluations of tissues from the 
reproductive systems in male and female animals of both species did not 
demonstrate any lesions, morphological changes or weight variations. 
Although the functionality of the reproductive systems were not 
evaluated, there was no indication that the HEDP treatment affected 
these tissues.
    In a 90-day feeding study, rats were fed diets containing 3,000, 
10,000 or 30,000 ppm HEDP (disodium monohydrate salt). At 30,000 ppm 
average body weight gains of both males and females were reduced and 
absolute and relative liver weights of males were decreased. Increased 
erythrocyte counts (males), decreased hemoglobin concentration (both 
sexes), decreased hematocrit values (both sexes), and decreased 
leukocyte counts (females at 84-days only) were observed at 30,000 ppm. 
No other hematologic, urinalysis, or clinical chemistry parameter was 
affected. The no-observed-effect level (NOEL) was greater than 10,000 
ppm.
    The disodium monohydrate salt of HEDP was administered to beagle 
dogs at dietary concentrations of 1,000, 3,000, or 10,000 ppm for 90-
days. No adverse hematologic, biochemical, or histopathologic effects 
were observed. The NOEL was 10,000 ppm.
    The NOEL from both the rat and the dog studies was 10,000 ppm. 
Based on the data from these studies the daily intake of HEDP can be 
estimated. The estimated intake of HEDP by male and female rats at 
10,000 ppm was 635 and 724 milligrams/kilogram/day (mg/kg/day), 
respectively. The estimated intake of HEDP by male and female dogs at 
10,000 ppm was 278 and 385 mg/kg/day, respectively.
    5. Carcinogenicity. Nothing in the available literature suggests 
that HEDP is known to be a carcinogen; thus, a discussion of aggregate 
excess lifetime cancer risk resulting from exposure to the chemical 
from residues in food and drinking water (ground and surface water) and 
from residential and other non-occupational source(s) is not 
applicable.
    6. Endocrine effects. HEDP does not acts as an endocrine disrupter 
or possess intrinsic hormonal activity.

B. Aggregate Exposure

    1. Dietary exposure--i. Food. There are no established U.S. food 
tolerances for HEDP. Because the compound has an affinity for water, 
residues are expected to drain away with wash water instead of 
``sticking'' to the food items. Tests on broccoli and tomatoes indicate 
only trace amounts of HEDP remain on these food items that have 
contacted treated equipment. For broccoli (cut), an average of 0.78 ppb 
HEDP residues were found. An average of 0.09 ppb HEDP residues were 
found on tomatoes. While these data are not meant to be representative 
of all fruits and vegetables, it shows that any potential HEDP residues 
are not significant. Dietary exposure from the proposed use is 
possible; however, any residues that may remain are expected to be very 
minimal and, because of the low toxicity of the undiluted raw material, 
these residues would not be of toxicological concern.
    ii. Drinking water. There should be no concern about the potential 
for transfer of HEDP residues to human drinking water because it does 
not interfere with routine removal of organics in laboratory semi-
continuous activated sludge sewage treatment units. Because of the 
physical chemistry of this compound, it is unlikely that any States are 
conducting water monitoring programs for HEDP.
    HEDP is proposed for use as an inert ingredient in a pesticide 
formulation used on fruits, vegetables, tree nuts, cereal grain, herbs, 
and spices. HEDP is classified as slow to intermediate in 
biodegradation to CO2. Additionally, the biodegradation is 
accelerated by light. Data in the aforementioned reference indicates 
that 0.2 ppm HEDP solutions in a mineral medium biodegrade by 79% in 3-
days when exposed to sunlight.
    The maximum expected concentration of HEDP in waste water treatment 
streams from the use of the proposed pesticide product is 0.07 ppm. 
Furthermore, HEDP will biodegrade in waste water treatment plants and 
in the environment. Therefore, HEDP released from the use of the 
proposed pesticide product poses no threat to drinking water.
    iii. Non-dietary, non-occupational exposure. The estimated non-
occupational exposure to HEDP has been evaluated based on its proposed 
use pattern.
    The compound, as an inert ingredient in a pesticide formulation in 
the form of a soluble concentrate/liquid, is used in industrial and 
commercial settings.
    HEDP use in homes does not occur.
    The potential for significant non-occupational non-dietary exposure 
under the use proposed in this petition to the general population 
(including infants and children) is unlikely. HEDP is proposed in this 
petition to be used only at commercial establishments (including farms) 
and is not to be used in or around the home.
    iv. Environmental fate and ecological effects. HEDP is classified 
as slow to intermediate in biodegradation to CO2. 
Additionally, the biodegradation is accelerated by light. Data in the 
aforementioned reference indicates that 0.2 ppm HEDP solutions in a 
mineral medium biodegrade by 79% in 3-days when exposed to sunlight. 
Degradation of HEDP has been shown in several test soils at rates 
similar to biodegradable linear alkybenzenesulfonate. Complexes of HEDP 
with copper (II) and iron (III) rapidly photodegrade in aqueous 
solution under irradiation from a mercury arc lamp in the laboratory.

[[Page 66093]]

    Environmental effects data on HEDP (including Daphnia magna, Midge 
Larvae, Grass Shrimp, Oyster Shell Deposition, Bluegill Sunfish, 
Rainbow Trout, Channel Catfish, and Sheepshead Minnow) show HEDP is 
classified as practically non-toxic, with the exception of oysters, in 
which it is classified as being slightly toxic. The maximum expected 
concentration of HEDP in waste water treatment streams from the use of 
the proposed pesticide product is 0.07 ppm. This value is three orders 
of magnitude below the lowest toxic concentration listed above 
(oysters). Furthermore, HEDP will biodegrade in waste water treatment 
plants and in the environment. Therefore, HEDP released from the use of 
the proposed pesticide product poses no threat to aqueous organisms 
present in the environment.

C. Cumulative Effects

    Review of EPA's list of inert ingredients found no similar approved 
inert ingredients or compounds with similar structures.
    The list of currently registered active ingredients from the 
National Pesticide Information Retrieval System (NPIRS) was reviewed 
for compounds similar to HEDP. The ethylene-releasing growth regulator 
ethephon (chemical name 2-chloroethylphosphonate) is somewhat similar 
in that a two-carbon fragment is the organic component of a phosphonic 
acid. However, HEDP contains two phosphonic acid groups attached to the 
same carbon and contains no chlorine. Ethephon, on the other hand, 
contains a single phosphonic moiety but has a chlorine attached at the 
2-position of the ethyl group. Further, the mode of action of ethephon 
is to release ethylene by rapidly decomposing with loss of the chlorine 
and the phosphonate; this pathway is not available for HEDP. Thus, 
combining exposures to HEDP with this compound is not appropriate.

D. Safety Determination

    1. U.S. population. Tests conducted by Ecolab Inc. indicate very 
low residues of HEDP are expected to remain on treated commodities 
(whether raw agricultural commodities or processed); thus, exposure to 
the U.S. general population including infants and children would be 
very minimal as a result of the proposed use.
    In testing for Ecolab using tomatoes and broccoli the HEDP residue 
on these vegetables was generally below 1 ppb. Assuming that a normal 
adult weighing 70 kg ingests approximately 2,000 g of food a day, and 
that all the food ingested is fruits and vegetables that contain a 1 
ppb residue of HEDP, the daily intake of HEDP would be estimated at 
0.000027 mg/kg/day.
    Comparing the daily intake of HEDP under these worst case 
situations with the lowest NOEL for HEDP in the subchronic animal 
studies (278 mg/kg/day) provides a margin of exposure of approximately 
10,000,000. Clearly this larger margin of exposure demonstrates the 
lack of concern about the presence of the minute residues of HEDP on 
food.
    Dietary exposure to HEDP is possible; however, any residues that 
may remain are expected to be very minimal and, because of the low 
toxicity of the undiluted raw material, these residues would not be of 
toxicological concern.
    Therefore, exposure of this inert ingredient (from the use proposed 
in this petition) to the U.S. general population would not pose a 
health risk.
    2. Infants and children. HEDP should not pose a health risk to the 
U.S. population subgroup of infants and children.
    Tests conducted by Ecolab Inc. indicate very low residues of HEDP 
are expected to remain on treated commodities (whether raw agricultural 
commodities or processed); thus, exposure to the U.S. general 
population including infants and children would be very minimal as a 
result of the proposed use. Dietary exposure to HEDP is possible; 
however, any residues that may remain are expected to be very minimal 
and, because of the low toxicity of the undiluted raw material, these 
residues would not be of toxicological concern.
    Therefore, exposure of this inert ingredient (from the use proposed 
in this petition) should not pose a health risk to the U.S. population 
subgroup of infants and children.

E. Analytical Method

    Because this petition is for an exemption from the requirement of a 
tolerance, an enforcement method for HEDP is not needed. However, a 
spectrophotometric method to determine residues of HEDP has been 
submitted to the Agency .

F. International Tolerances

    The petitioner understands that there are no current established 
Maximum Residue Levels for HEDP.

2. Wacker Silicones Corporation

PP 7E4794

    EPA has received a pesticide petition (PP 7E4794) from Walker 
Silicones Corporation, on behalf of Wacker-Chemie, 3301 Sutton Road, 
Adrain, Michigan 49221-9397 proposing pursuant to section 408(d) of the 
Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a(d), to amend the 
exemption from the requirement of a tolerance established under 40 CFR 
180.1001(c) for the residues of pentaerythritol stearates (CAS. No. 
85116-93-4) from 25 ppm to 500 ppm.
    EPA has determined that the petition 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 the petition. 
Additional data may be needed before EPA rules on the petition.

A. Proposed Use Practices

    As in the tolerance exemption established and published in the 
Federal Register on July 3, 1996 (61 FR 34741-34743) (FRL-5381-2), the 
proposed use of a pentaerythritol stearates which include 
pentaerythritol monostearate (CAS No. 78-23-9), pentaerythritol 
distearate (CAS No. 13081-97-5), pentaerythritol tristearate (CAS No. 
28188-24-1), pentaerythritol tetrastearate (CAS No. 115-83-3) is 
limited to agricultural food use. This includes use on crops and seeds 
used to grow crops.

B. Toxicological Profile

    A summary of the toxicology data is included in the proposed rule 
that was published in the Federal Register on April 17, 1996 (61 FR 
16747-16749) (FRL-5355-7).
    Pentaerythritol stearates are large, branched hydrocarbons. All 
carbon-carbon bonds are single bonds. Degradation is anticipated in the 
presence of enzymes. Hypothesized degradation products include free 
pentaerythritol and stearic acid (a natural product). The degradation 
products are likely to be polar and readily eliminated in urine.
    1. Acute toxicity. The acute oral LD50 in rats was 
determined to be >2,000 mg/kg. This study demonstrates that the mixture 
of pentaerythritol stearates is practically non-toxic to mammals. 
Wacker Silicones Corporation and Wacker-Chemie are not aware of any 
data that suggest that pentaerythritol stearates pose any potentially 
greater acute risk to infants or children.
    2. Reproductive and developmental toxicity. Wacker Silicones 
Corporation and Wacker-Chemie are not aware of any developmental or 
reproductive effects resulting from exposure to pentaerythritol 
stearates.
    3. Chronic toxicity. Wacker Silicones Corporation and Wacker-Chemie 
are not aware of any effects resulting from chronic exposure to 
pentaerythritol

[[Page 66094]]

stearates. In addition, Wacker Silicones Corporation and Wacker-Chemie 
are not aware of any data that suggests that chronic exposure to 
pentaerythritol stearates, including during infancy and childhood, 
poses any potentially greater lifetime risk.
    4. Carcinogenicity. Wacker Silicones Corporation and Wacker-Chemie 
are not aware of any oncogenic effects resulting from exposure to 
pentaerythritol stearates. In addition, Wacker Silicones Corporation 
and Wacker-Chemie are not aware of any data that suggests that chronic 
exposure to pentaerythritol stearates, including during infancy and 
childhood, poses any potentially greater lifetime cancer risk.
    5. Endocrine effects. Pentaerythritol stearates are not 
structurally similar to any compounds with known endocrine effects. 
Wacker Silicones Corporation and Wacker-Chemie are not aware of any 
endocrine effects resulting from exposure to pentaerythritol stearates 
either individually or in combination with other substances.

C. Aggregate Exposure

    Exposure to pentaerythritol stearates via both the diet and 
drinking water is anticipated to be negligible. Pentaerythritol 
stearates are ingredients in a product that Wacker-Chemie proposes to 
market in the United States exclusively as an inert ingredient in 
pesticide formulations that are used exclusively on crops and seeds 
used to grow crops.
    1. Dietary exposure-- Food. In its review on the previous 
exemption, EPA's Chemistry Branch determined that the maximum residue 
of pentaerythritol stearates in food/feed resulting from a single 
application of pentaerythritol stearates at 0.53 grams/acre (0.0012 lb/
acre) would be 0.6 ppm assuming that (a) all the pentaerythritol 
stearates contained in the pesticide formulation applied to the crop 
are in the harvested commodity, (b) there is no loss of residue through 
weathering or volatilization, and (c) pentaerythritol stearates are 
used on low yield crops (2,000 lb/acre). Further assuming that (i) a 
maximum of 10 applications per season, (ii) all crops are treated at 
the proposed maximum seasonal rate, the maximum theoretical seasonal 
residues of pentaerythritol stearates would be 6 ppm.
    Actual seasonal residues are anticipated to be several orders of 
magnitude lower than the 6 ppm calculated maximum residue for the 
following reasons:
    (i) Only a portion of the pesticide spray is intercepted by edible 
plant parts.
    (ii) Degradation of residues following application is anticipated.
    (iii) Treated crops may be medium or high yield crops.
    (iv) Crops generally received less than 10 applications per season.
    (v) Only a small percentage of pesticide formulations will include 
pentaerythritol stearates as an inert ingredient.
    Actual seasonal residues of pentaerythritol stearates are therefore 
anticipated to be negligible.
    2. Drinking water. Exposure to pentaerythritol stearate via 
drinking water will be negligible. Pentaerythritol stearates have very 
low solubility in water (>0.1 mg/100 g water at 30 deg. C). Solubility 
in organic solvents is also anticipated to be low due to the high 
molecular weight (403- 1201 amu) of the pentaerythritol stearates. The 
potential for pentaerythritol stearate contamination of ground water or 
surface water is therefore negligible. If residues did contaminate 
ground water or surface water, it is highly probable that the low 
solubility of pentaerythritol stearates in water and organic solvents 
would result in removal of the residues via standard drinking water 
purification techniques.
    3. Non-dietary, non-occupational exposure. Pentaerythritol 
stearates are ingredients in a product that Wacker-Chemie proposes to 
market in the United States exclusively as an inert ingredient in 
pesticide formulations that are used exclusively on crops and seeds 
used to grow crops. No non-occupational exposure of the United States 
population to pentaerythritol stearates will result from the proposed 
use of pentaerythritol stearates.

D. Cumulative Effects

    Pentaerythritol stearates do not have any known significant 
toxicological mechanism or mode of action. Therefore, there is no known 
significant cumulative risk associated with the proposed use of 
pentaerythritol stearates.

E. Safety Determination

    1. U.S. population. Exposure to pentaerythritol stearates via both 
the diet and drinking water is anticipated to be negligible. 
Pentaerythritol stearates are ingredients in a product that Wacker-
Chemie proposes to market in the United States exclusively as an inert 
ingredient in pesticide formulations that are used exclusively on crops 
and seeds used to grow crops. No non-occupational exposure of the 
United States population to pentaerythritol stearates will result from 
the proposed use of pentaerythritol stearates. Aggregate exposure to 
pentaerythritol stearates is therefore anticipated to be negligible.
    2. Infants and children. Wacker Silicones Corporation and Wacker-
Chemie are not aware of any data that suggest that pentaerythritol 
stearates pose any potential greater acute or chronic risk to infants 
or children.

F. International Tolerances

    There are no Codex maximum residue levels (MRLs) or exemptions from 
MRLs for pentaerythritol stearates established for residues of 
pentaerythritol stearates.
[FR Doc. 97-32932 Filed 12-16-97; 8:45 am]
BILLING CODE 6560-50-F