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Notice of Filing of Pesticide Petitions
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: December 17, 1997 (Volume 62, Number 242)]
[Notices]
[Page 66091-66094]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17de97-74]
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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-
docket@epamail.epa.gov. 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:
acierto.amelia@epamail.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-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:
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-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]
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