[Federal Register Volume 64, Number 51 (Wednesday, March 17, 1999)]
[Notices]
[Pages 13195-13198]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6183]


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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: [email protected].
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:
    [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 5.1/6.1 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 LD50 (rat) is greater than 2,000 milligram kilogram 
(mg/kg), and the acute dermal LD50 (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 LD50 (rat) is 
greater than 2,000 milligram kilogram (mg/kg), and the acute dermal 
LD50 (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]
BILLING CODE 6560-50-F