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Notice of Filing; Pesticide Petitions
Note: EPA no longer updates this information, but it may be useful as a reference or resource.
[Federal Register: March 17, 1999 (Volume 64, Number 51)]
[Notices]
[Page 13195-13198]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17mr99-58]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-863; FRL-6065-5]
Notice of Filing; 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-863, must
be received on or before April 16, 1999.
ADDRESSES: By mail submit written comments to: Information and Records
Integrity Branch, Public Information and Services Divison (7502C),
Office of Pesticides Programs, Environmental Protection Agency, 401 M
St., SW., Washington, DC 20460. In person bring comments to: Rm. 119,
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. 119 at the
address given above, from 8:30 a.m. to 4 p.m., Monday through Friday,
excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: Bipin Gandhi, Registration Support
Branch, Registration Division (7505C), Office of Pesticide Programs,
Environmental Protection Agency, 401 M St., SW, Washington, DC 20460.
Office location, telephone number, and e-mail address: Rm. 707A,
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA 22202,
(703) 308-8380; e-mail: gandhi.bipin@epamail.epa.gov.
SUPPLEMENTARY INFORMATION: EPA has received a pesticide petition as
follows proposing the establishment and/or amendment of regulations for
residues of certain pesticide chemical 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 this petition
contains 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-863] (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 5.1/6.1 file format or
ASCII file format. All comments and data in electronic form must be
identified by the docket control number [PF-863] 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.
Dated: March 3, 1999.
Peter Caulkins,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner summary of the pesticide petition is printed below
as required by section 408(d)(3) of the FFDCA. The summary of the
petition was prepared by the petitioner and represents the views of the
petitioner. 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. Rhodia Inc.
PP 8E4956
EPA has received a pesticide petition (PP 8E4956) from Rhodia Inc.,
CN 7500 Cranbury, NJ 08512-7500, proposing pursuant to section 408(d)
of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(d), to
amend 40 CFR part 180 to request exemption from the requirements of a
tolerance for a-alkyl (C8-C16)-w-hydroxy poly(oxyethylene) mixture of
dihydrogen phosphate and monohydrogen phosphate esters and the
corresponding ammonium, calcium, isopropylamine, magnesium,
monoethanolamine, potassium, sodium and zinc salts of the phosphate
esters; the poly(oxyethylene) content averages 3 - 20 moles, in or on
raw agricultural commodities. 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 of the petition. Additional data may be needed before
EPA rules on the petition.
[[Page 13196]]
A. Residue Chemistry
The Federal Register of July 7, 1995 (60 FR 35396) announced the
reclassification of a number of inert ingredients from List 3 to List
4B (minimal risk). The EPA included octyloxypoly(ethyleneoxy)ethyl
phosphate (C8 ethoxylated phosphate ester) among the inerts of minimal
risk indicating:
1. ``On behalf of the Office of Pesticide Programs, these
substances were reviewed by the Structure Activity Team of EPA's Office
of Pollution Prevention and Toxics with each judged to be of low
concern for potential human health and/or environmental effects.''
2. ``These inert ingredients were evaluated by the Office of
Pesticide Program's Inert Review Group and determined to be of minimal
risk.''
3. ``A list of these inert ingredients proposed for
reclassification was provided to EPA's Office of Water and to the FDA's
Center for Food Safety and Applied Nutrition for comment; no adverse
comments were received.''
Additionally, EPA has already exempted from the requirements of a
tolerance under 40 CFR 180.1001(d): a-alkyl (C10-C16)-w-hydroxy
poly(oxyethylene) mixture of dihydrogen phosphate and monohydrogen
phosphate esters and the corresponding ammonium, calcium, magnesium,
monoethanolamine, potassium, sodium and zinc salts of the phosphate
esters; the poly(oxyethylene) content averages 3 - 20 moles.
The extension of the alkyl range to include the C8 analog will not
alter the residue profile of the phosphate esters and their salts. In
fact, a number of exemptions including the C8 alkyl moiety are found in
40 CFR 180.1001, including n-octyl alcohol, alkyl amine acetates, alkyl
ethoxylates and alkyl sulfate isopropylamine salts. Further, it is
widely acknowledged that alcohol ethoxylates of the C10 - C16 range
contain minor amounts of the C8 and lower alkyl analogs, as well as C18
and higher analogs. This petition merely requests expansion of the
existing exemption from tolerance for the C10 - C16 range to include C8
alkyl ethoxylate phosphates and their salts.
The addition of the isopropylamine salts of these phosphate esters
acknowledges the fact that isopropylamine is a common counterion in
water-soluble herbicides.
B. Toxicological Profile
1. Acute toxicity. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305) (FRL-3190-1), the Agency set forth a list of studies which would
generally be used to evaluate the risks posed by the presence of an
inert ingredient in a pesticide formulation. However, where it can be
determined without the data that the inert ingredient will present
minimal or no risk, the Agency generally does not require some or all
of the listed studies to rule on the proposed tolerance or exemption
from the requirement of a tolerance for an inert ingredient. Rhodia
Inc. believes that the data and information described below is adequate
to ascertain the toxicology and characterize the risk associated with
the use of a-alkyl (C8-C16)-w-hydroxy poly(oxyethylene) mixture of
dihydrogen phosphate and monohydrogen phosphate esters and the
corresponding ammonium, calcium, isopropylamine, magnesium,
monoethanolamine, potassium, sodium and zinc salts of the phosphate
esters; the poly(oxyethylene) content averages 3 - 20 moles.
While not highly acutely toxic, alkyl ethoxylate phosphate esters
are known to be severely irritating to skin and eyes. However, their
corresponding salts have a reduced irritation potential. For the
specific alkylethoxylate phosphate ester salt blend that Rhodia Inc.
petitions for exemption from the requirements of a tolerance, the acute
oral LD<INF>50</INF> (rat) is greater than 2,000 milligram kilogram
(mg/kg), and the acute dermal LD<INF>50</INF> (rat) is greater than
2,000 mg/kg. The product is considered to be an eye irritant. The
product is non-irritating to rabbit skin and is negative for skin
sensitization.
2. Genotoxicity. An Ames test conducted on the product (blended
alkyl ethoxylate phosphates, isopropylamine salts) was negative.
3. Reproductive and developmental toxicity. The broad range of
structurally similar products which are presently approved for use in
pesticide formulations has not been reported to cause reproductive or
developmental toxicity.
4. Subchronic toxicity. Similar compounds are not known to exert
significant subchronic toxic effects.
5. Chronic toxicity. Similar compounds are not known to exert
significant chronic toxic effects.
6. Metabolite toxicology. Alcohol ethoxylates are already exempted
from the requirements of a tolerance under 40 CFR 180.1001 (c).
7. Endocrine disruption. There is no evidence that this product has
endocrine disruptor effects, individually or in combination with any
other chemical. Further, this product is not part of a class of
compounds that has previously been alleged to cause endocrine effects.
C. Aggregate Exposure
1. Food. As noted above, a-alkyl (C10 - C16)-w-
hydroxypoly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
magnesium, monoethanolamine, potassium, sodium,and zinc salts of the
phosphate esters; the poly(oxyethylene) content averages 3-20 moles
have already been exempted from the requirements of a tolerance under
40 CFR 180.1001(d). The expansion of the alkyl range to include the C8
alkyl moiety is not expected to significantly affect the dietary
exposure to these compounds. The inclusion of the isopropylamine salts
of these phosphate esters merely acknowledges the fact that
isopropylamine is a common counterion in water-soluble herbicides, and
thus approval of this petition would not be expected to substantially
increase the dietary intake of these compounds.
2. Drinking water. This class of products have been shown to
readily biodegrade and are therefore, not likely to be present in
potable water supplies.
3. Non-dietary exposure. Phosphate esters of alkyl ethoxylates, and
their salts are extensively used industrially as water-soluble
lubricants, as detergents and household cleaners, and in personal care
products in addition to their use as emulsifiers, dispersants and
suspending agents in pesticide formulations. The slight contribution to
total exposure resulting from granting the petition is not expected to
significantly alter the risk profile.
D. Cumulative Effects
As stated above, there are a wide range of structurally similar
compounds that are used in many products to which the U.S. population
is exposed. Rhodia Inc. is unaware of any cumulative effects occurring
from such uses. Further, the use of the product that is the subject of
the tolerance exemption petition is not likely to significantly
increase daily exposure to this class of similar compounds.
E. Safety Determination
1. U.S. population. In its notice Federal Register, July 7, 1995,
(60 FR 35396) which reclassified octyloxypoly(ethyleneoxy)ethyl
phosphate from List 3 to List 4B (inerts of minimal risk), the Agency
has stated :
i. ``On behalf of the Office of Pesticide Programs, these
substances were reviewed by the Structure Activity Team of EPA's Office
of Pollution
[[Page 13197]]
Prevention and Toxics with each judged to be of low concern for
potential human health and/or environmental effects.''
ii. ``These inert ingredients were evaluated by the Office of
Pesticide Program's Inert Review Group and determined to be of minimal
risk.''
iii. ``A list of these inert ingredients proposed for
reclassification was provided to EPA's Office of Water and to the FDA's
Center for Food Safety and Applied Nutrition for comment; no adverse
comments were received.''
Expansion of the uses of the product to food uses is not likely to
significantly increase the U.S. population's exposure to the product
and related compounds. Therefore, there is a reasonable certainty that
no harm to the U.S. population will result from the use described.
2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for pre- and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Margins of safety are incorporated into EPA risk assessments
either directly through the use of margin of exposure (MOE) analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans. There is no available data to
indicate any additional sensitivity of infants and children to this
product or to other similar products which have been in use for many
years and for numerous uses. There is no data which suggests that there
is a basis to require an additional margin of safety to be applied.
F. International Tolerances
Rhodia Inc. has demonstrated to the satisfaction of the Australian
Environmental Protection Authority and the Australian National
Registration Authority that certain formulations of blended alkyl
ethoxylate phosphate esters and salts are safe for use in and near
aquatic environments. Further, because of its enhanced properties, use
of this blend allows reduction of the total chemical burden of the
pesticide inert ingredients on the environment.
The alkyl ethoxylate phosphate monohydrogen and dihydrogen esters
and their salts, including the isopropylamine salts are being used as
inert ingredients in registered pesticide formulations applied to food
crops in 14 nations including European, African, South American and
Pacific Rim nations. These include: United Kingdom, France, Italy,
Spain, Japan, Australia, New Zealand, Brazil and Argentina.
Rhodia Inc. therefore respectfully requests that an exemption from
the requirements of a tolerance be established for a-alkyl (C8-C16)-w-
hydroxy poly(oxyethylene) mixture of dihydrogen phosphate and
monohydrogen phosphate esters and the corresponding ammonium, calcium,
isopropylamine, magnesium, monoethanolamine, potassium, sodium and zinc
salts of the phosphate esters; the poly(oxyethylene) content averages 3
- 20 moles, in or on raw agricultural commodities.
2. Rhodia Inc.
PP 8E4990
EPA has received a pesticide petition (PP 8E4990) from Rhodia Inc.,
CN 7500, Cranbury, NJ 08512-7500, proposing pursuant to section 408(d)
of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 346a(d), to
amend 40 CFR part 180 to request exemption from the requirement of a
tolerance for butoxytriethyleneglycol phosphate and the corresponding
ammonium, calcium, isopropylamine, magnesium, monoethanolamine,
potassium, sodium and zinc salts of the phosphate esters, and to
include use with water-soluble herbicide formulations in or on raw
agricultural commodities. 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 of the petition. Additional data may be needed before
EPA rules on the petition.
A. Residue Chemistry
The Federal Register of July 7, 1995 (60 FR 35396) announced the
reclassification of a number of inert ingredients from List 3 to List
4B (minimal risk). The EPA included butylpolyethoxyethanol esters of
phosphoric acid among those substances on List 4B, indicating:
1. ``On behalf of the Office of Pesticide Programs, these
substances were reviewed by the Structure Activity Team of EPA's Office
of Pollution Prevention and Toxics with each judged to be of low
concern for potentialhuman health and/or environmental effects.''
2. ``These inert ingredients were evaluated by the Office of
Pesticide Program's Inert Review Group and determined to be of minimal
risk.''
3. ``A list of these inert ingredients proposed for
reclassification was provided to EPA's Office of Water and to the FDA's
Center for Food Safety and Applied Nutrition for comment; no adverse
comments were received.''
Additionally, EPA has already exempted from the requirements of a
tolerance under 40 CFR 180.1001(d) the residues of
butoxytriethyleneglycol phosphate when used as a surfactant for
arsenical herbicides.
The addition of the isopropylamine salts of this phosphate ester to
the list of substances considered exempt from the requirements of a
tolerance merely acknowledges the fact that isopropylamine is a common
counterion in water-soluble herbicides.
B. Toxicological Profile
1. Acute toxicity. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305) (FRL 3190-1), the Agency set forth a list of studies which would
generally be used to evaluate the risks posed by the presence of an
inert ingredient in a pesticide formulation. However, where it can be
determined without the data that the inert ingredient will present
minimal or no risk, the Agency generally does not require some or all
of the listed studies to rule on the proposed tolerance or exemption
from the requirement of a tolerance for an inert ingredient. Rhodia
Inc. believes that the data and information described below is adequate
to ascertain the toxicology and characterize the risk associated with
the use of butoxytriethyleneglycol phosphate and the corresponding
ammonium, calcium, isopropylamine, magnesium, monoethanolamine,
potassium, sodium and zinc salts of the phosphate esters.
Alkyl ethoxylate phosphate esters are known to be severely
irritating to skin and eyes. However, their corresponding salts have a
reduced irritation potential. For the specific alkyl ethoxylate
phosphate ester blend that Rhodia Inc. petitions for exemption from the
requirements of a tolerance, acute oral LD<INF>50</INF> (rat) is
greater than 2,000 milligram kilogram (mg/kg), and the acute dermal
LD<INF>50</INF> (rat) is greater than 2,000 mg/kg. The product is non-
irritating to rabbit skin and is negative for skin sensitization. The
product is considered to be an eye irritant.
2. Genotoxicity. An Ames test conducted on the blended alkyl
ethoxylate phosphate salts was negative.
3. Reproductive and developmental toxicity. The broad range of
structurally similar compounds has not been reported to produce
reproductive or developmental toxicity.
[[Page 13198]]
4. Subchronic toxicity. Similar compounds are not know to exert
significant subchronic toxic effects.
5. Chronic toxicity. Similar compounds are not know to exert
significant chronic toxic effects.
6. Metabolite toxicology. Alcohol ethoxylates are already exempted
from the requirements of a tolerance under 40 CFR 180.1001(c).
Diethyleneglycol monobutyl ether, ethyleneglycol monobutyl ether and n-
butanol are specifically exempted from the requirements of a tolerance
under 40 CFR 180.1001(d). Triethylene glycol monobutyl ether, a likely
metabolite, has been reported Patty's Industrial Hygiene and
Toxicology, Fourth Edition, Volume II, Part D, ed. George D. Clayton,
and Florence E. Clayton (New York: John Wiley & Sons, 1994), 2,860 to
exhibit low acute toxicity by oral and dermal routes, to be non-toxic
by the inhalation route, and to cause eye irritation and slight skin
irritation.
7. Endocrine disruption. There is no evidence that this product has
endocrine disruptor effects, individually or in combination with any
other chemical. Further, this product is not part of a class of
compounds that has previously been alleged to cause endocrine effects.
C. Aggregate Exposure
1. Food. As noted above, butoxytriethyleneglycol phosphate has
already been exempted from the requirements of a tolerance under 40 CFR
180.1001(d). The addition of the expanded use to include use with
water-soluble herbicides is not expected to significantly affect the
dietary exposure to these compounds. The inclusion of the
isopropylamine salts of these phosphate esters merely acknowledges the
fact that isopropylamine is already a common counterion in water-
soluble herbicides. Thus approval of this petition would not be
expected to substantially increase the dietary intake of these
compounds.
2. Drinking water. The product has been shown to readily biodegrade
and therefore is not likely to be present in potable water supplies.
3. Non-dietary exposure. Phosphate esters of alkyl ethoxylates are
widely used industrially as water-soluble lubricants, as detergents and
household cleaners, and in personal care products in addition to their
use as emulsifiers, dispersants and suspending agents in pesticide
formulations. Given the widespread use of this group of compounds, the
additional exposure resulting from granting the petition is not
expected to significantly alter the risk profile.
D. Cumulative Effects
As stated above, there are a wide range of structurally similar
compounds that are used in many products to which the U.S. population
is exposed. Rhodia Inc. is unaware of any cumulative effects occurring
from such uses. Further, the use of the product that is the subject of
the tolerance exemption petition is not likely to significantly
increase daily exposure to this class of similar compounds.
E. Safety Determination
1. U.S. population. In its notice of July 7, 1995 (60 FR 35396);
which moved butylpolyethoxyethanol esters of phosphoric acid from List
3 to List 4B (inerts of minimal risk), EPA stated :
i. ``On behalf of the Office of Pesticide Programs, these
substances were reviewed by the Structure Activity Team of EPA's Office
of Pollution Prevention and Toxics with each judged to be of low
concern for potential human health and/or environmental effects.''
ii. ``These inert ingredients were evaluated by the Office of
Pesticide Program's Inert Review Group and determined to be of minimal
risk.''
iii. `` List of these inert ingredients proposed for
reclassification was provided to EPA's Office of Water and to the FDA's
Center for Food Safety and Applied Nutrition for comment; no adverse
comments were received.''
Expansion of the uses of the product to food uses is not likely to
significantly increase the U.S. population's exposure to the product
and related compounds. Therefore, there is a reasonable certainty that
no harm to the U.S. population will result from the use described.
2. Infants and children. FFDCA section 408 provides that EPA shall
apply an additional tenfold margin of safety for infants and children
in the case of threshold effects to account for pre- and postnatal
toxicity and the completeness of the data base unless EPA concludes
that a different margin of safety will be safe for infants and
children. Margins of safety are incorporated into EPA risk assessments
either directly through the use of margin of exposure (MOE) analysis or
through using uncertainty (safety) factors in calculating a dose level
that poses no appreciable risk to humans. There is no available data to
indicate any additional sensitivity of infants and children to this
product or to other similar products which have been in use for many
years and for numerous uses. There is no data which suggests that there
is a basis to require an additional margin of safety to be applied.
F. International Tolerances
Rhodia Inc. has demonstrated to the satisfaction of the Australian
Environmental Protection Authority and the Australian National
Registration Authority that certain formulations of blended alkyl
ethoxylate phosphate esters and salts are safe for use in and near
aquatic environments. Further, because of its enhanced properties, use
of this blend allows reduction of the total chemical burden on the
environment.
The alkyl ethoxylate phosphate monohydrogen and dihydrogen esters
and their salts, including the isopropylamine salts are being used as
inert ingredients in registered pesticide formulations applied to food
crops in 14 nations including European, African, South American and
Pacific Rim nations. These include: United Kingdom, France, Italy,
Spain, Japan, Australia, New Zealand, Brazil and Argentina.
Rhodia Inc. therefore, respectfully requests that an exemption from
the requirements of a tolerance be established for
butoxytriethyleneglycol phosphate and the corresponding ammonium,
calcium, isopropylamine, magnesium, monoethanolamine, potassium, sodium
and zinc salts of the phosphate esters, and to include use with water-
soluble herbicide formulations in or on raw agricultural commodities
under 40 CFR 180.1001(d).
[FR Doc. 99-6183 Filed 3-16-99; 8:45 am]
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