[Federal Register Volume 64, Number 12 (Wednesday, January 20, 1999)]
[Notices]
[Pages 3092-3096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1250]
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ENVIRONMENTAL PROTECTION AGENCY
[PF-845; FRL-6043-8]
Kuraray America, Inc.; Pesticide Tolerance Petition Filing
AGENCY: Environmental Protection Agency (EPA).
[[Page 3093]]
ACTION: Notice.
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SUMMARY: This notice announces the initial filing of a pesticide
petition proposing the establishment of regulations for residues of a
certain pesticide chemical in or on various food commodities.
DATES: Comments, identified by the docket control number PF-845, must
be received on or before February 19, 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 (7505W), 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-845] (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-845) 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: January 12, 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 9analytical methods available to
EPA for the detection and measurement of the pesticide chemical
residues or an explanation of why no such method is needed.
Kuraray America, Inc.
PP 8E4949
EPA has received a pesticide petition (PP 8E4949) from Kuraray
America, Inc., 200 Park Avenue, New York, N.Y. 10166-3098, 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) and (e) to establish an
exemption from the requirement of a tolerance as a pesticide inert
ingredient in or on raw agricultural commodities for polyvinyl acetate,
sulfoxyl group modified sodium salt (Vinylon VF-HP-2) in or on the 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. Toxicological Profile
Polyvinyl acetate, sulfoxyl group modified, sodium salt conforms
to the definition of polymer given in 40 CFR 723.250(b), except that it
is biodegradable under the stability test conditions and is water
soluble.
1. Polyvinyl acetate, sulfoxyl group modified, sodium salt is not
cationic or potentially cationic.
2. Polyvinyl acetate, sulfoxyl group modified, sodium salt contains
as an integral part of it's composition at least two of the required
atomic elements, and does not contain elements above permitted levels
or any elements not permitted by the atomic element limitation.
3. Polyvinyl acetate, sulfoxyl group modified, sodium salt is not
manufactured or imported from monomers and/or other reactants that are
not already included on the TSCA Chemical Substance Inventory.
4. Polyvinyl acetate, sulfoxyl group modified, sodium salt has a
number average molecular weight 10,000 Dalton (typical
number average molecular weight of 62,800 Dalton) and maximum oligomer
contents of 0.00% <500 and 0.0% < 1,000.
5. Stability: Polymers cannot be manufactured under the amended
TSCA exemption if they substantially degrade, decompose, or
depolymerize, or are designed (or can be reasonably anticipated) to
substantially degrade, decompose or depolymerize prior to, during or
after use. This exclusion includes polymers with such properties after
disposal. A similar exclusion was made a part of the original TSCA
[[Page 3094]]
exemption rule because it is not feasible for EPA to anticipate all
possible breakdown products that could result from polymers otherwise
eligible, and it is therefore not possible for EPA to define precisely
in advance which polymers with this property are intrisically safe.
Polymers that otherwise satisfy all the criteria of the TSCA exemption
may still be intrinsically safe even if they are designed or reasonably
anticipated to break down prior to, during, or after use, depending
upon the extent to which they break down and the nature of any
persistent break-down products. Kurary America, Inc. conducted tests on
the stability of the polyvinyl acetate, sulfoxyl group modified, sodium
salt polymer and found it to be biodegradable under the test
conditions.
Polyvinyl acetate, sulfoxyl group modified, sodium salt is not a
water-absorbing polymer, and therefore is not excluded from eligibility
for the amended TSCA exemption. The exclusion in the amended polymer
exemption rule is intended primarily to address concerns for ``super
absorbent'' polymers or ``super slurpers'', which have the capacity to
absorb 60 to 100 times their own mass of water, yet not dissolve.
Polyvinyl acetate, sulfoxyl group modified, sodium salt does not fall
within this exclusion because it dissolves in water rather than
absorbing it.
Based on conformance to the criteria for TSCA polymer exemption,
polymers can be anticipated to have no mammalian toxicity from dietary,
inhalation or dermal exposure. The polyvinyl acetate, sulfoxyl group
modified, sodium salt polymer conforms with all the criteria except
that it is biodegradable. This characteristic of biodegradability is
not anticipated to have any impact on mammalian toxicity from dietary,
inhalation or dermal exposure, but rather is a factor which serves to
diminish the possibility of exposure.
B. Aggregate Exposure
The Agency has maintained that polymers meeting the polymer
exemption criteria (as described previously for polyvinyl acetate,
sulfoxyl group modified, sodium salt), will present minimal risk to
human health when used as inert ingredients in pesticide products
applied to food crops. EPA has also established exemptions from
tolerance for polymeric materials used as pesticide inert ingredients
that it considers to be intrinsically safe based on the fact that they
are listed on the TSCA Inventory or meet the requirements of the
amended TSCA polymer exemption and are thereby not subject to the
requirements of pre-manufacturing notification.
Non-dietary exposure. Based on the conformance of polyvinyl
acetate, sulfoxyl group modified, sodium salt to the definition of a
polymer given in 40 CFR 723.250(b), as well as the criteria that are
used to identify low risk polymers, EPA can conclude that there is a
reasonable certainty that no harm to the U.S. population will result
from non-dietary exposures to it.
C. Cumulative Effects
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance or tolerance
exemption, the Agency consider ``available information'' concerning the
cumulative effects of a particular chemical's residues and ``other
substances that have a common mechanism of toxicity''. In the case of
the polyvinyl acetate, sulfoxyl group modified, sodium salt, the lack
of expected toxicity of this substances based on its conformance to the
definition of polymers as given in 40 CFR 723.250(b), as well as the
criteria that identify low risk polymers, results in no expected
cumulative effects. A cumulative risk assessment is therefore not
necessary.
D. Safety Determination
1. U.S. population. As a matter of policy, EPA has in the past
established exemptions from tolerance for polymeric materials used as
pesticide inert ingredients that it considers to be intrinsically safe
based on the fact that they are listed on the TSCA Inventory or meet
the requirements of the amended TSCA polymer exemption and are thereby
not subject to the requirements of pre-manufacturing notification. The
Agency has maintained that polymers meeting the polymer exemption
criteria will present minimal risk to human health when used as inert
ingredients in pesticide products applied to food crops.
2. Infants and childen. FFDCA section 408 provides that EPA shall
supply an additional tenfold margin of safety for infants and children
in the case of threshold effects where pre- and/or postnatal toxicity
are found or there is incompleteness 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.
Due to the low expected toxicity of polyvinyl acetate, sulfoxyl
group modified, sodium salt, a safety factor analysis is not required
in assessing the risk. For the same reasons the additional safety
factor is unnecessary.
E. Analysis of TSCA Polymer Exemption Applicability
1. Polymer definition. In order to apply the criteria of the
polymer exemption, it is essential that the chemical identity of
polymer be established precisely, if possible. In the case of polyvinyl
acetate, hydrolyzed, sulfonate-modified sodium salt (Vinylon VF-HP-2),
the precursors are simple chemicals that can be fully characterized and
their reaction products are clearly defined.
Under the amended TSCA polymer exemption, a substance must meet the
definition of a polymer, which is: A chemical substance that consists
of not less than 50.0% (a simple majority) of polymer molecules and
less than 50.0% of molecules with the same molecular weight, wherein
the polymer molecules are distributed over a range of molecular weights
and the differences among polymer molecules are primarily due to
differences in the number of internal monomer units. Polyvinyl acetate,
sulfoxyl group modified, sodium salt satisfies the polymer definition.
2. Exclusions: 40 CFR 723.250(d)--i. Unreviewed reactants. Under
the amended TSCA polymer exemption, a manufacturer or importer is not
allowed to commercialize a polymer if any one or more of the reactants
used or incorporated at two weight percent or more are not listed on
the TSCA Inventory or manufactured under an applicable exemption to
section 5 of TSCA. All monomers and other reactants involved in
manufacturing polyvinyl acetate, sulfoxyl group modified, sodium salt
are listed on the TSCA Inventory.
ii. Positively charged polymers. Cationic or potentially cationic
polymers are excluded under paragraph (d)(1) from the TSCA polymer
exemption unless the charge density is sufficiently low or the polymer
is a non-dispersible, non-soluble solid. Polyvinyl acetate, sulfoxyl
group modified, sodium salt is not cationic or potentially cationic.
iii. Atomic element limitations. The exclusion at (d)(2) limits the
identities of atomic elements in the composition of polymers eligible
for the TSCA exemption. All such polymers must contain as an integral
part of their composition two or more of the atomic
[[Page 3095]]
elements, carbon, hydrogen, nitrogen, oxygen, silicon and sulfur. The
specific monatomic counter ions, Na+, Mg+2,
Al+3, K+ and Ca+2 are permitted.
Chlorine, bromine, and iodine are permitted whether they are covalently
bonded to carbon or as the specific monatomic counter ions, Cl-, Br-
and I-. Fluorine must be covalently bound to carbon. Lithium, boron,
phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin, or
zirconium are permitted at less than 0.20 weight percent alone or in
any combination. No other atomic elements are permitted and other
exclusions may apply.
Polyvinyl acetate, sulfoxyl group modified, sodium salt contains at
least two of the required atomic elements, and it does not contain
elements above permitted levels or any elements not permitted by this
limitation.
iv. Instability. Polymers cannot be manufactured under the amended
TSCA exemption if they substantially degrade, decompose, or
depolymerize, or are designed (or can be reasonably anticipated) to
substantially degrade, decompose or depolymerize prior to, during or
after use. This exclusion includes polymers with such properties after
disposal, for example, in a waste water treatment plant. A similar
exclusion was made a part of the original TSCA exemption
rule1. This provision is present in the amended rule,
because it is not feasible for EPA to anticipate all possible breakdown
products that could result from polymers otherwise eligible, and it is
therefore not possible for EPA to define precisely in advance which
polymers with this property are intrinsically safe. Polymers that
otherwise satisfy all the criteria of the TSCA exemption, may still be
intrinsically safe even if they are designed or reasonably anticipated
to break down prior to, during, or after use, depending upon the extent
to which they break down and the nature of any persistent bread-down
products.
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\1\ 49 FR 46066 November 21, 1984.
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Kuraray America, Inc. conducted tests on the stability of the VF-
HP-2 polymer and found it to be biodegradable under the test
conditions. In a study using aerobic soil microorganisms from a
municipal water treatment plant, the VF-HP-2 polymer, the polyvinyl
acetate, hydrolyzed, sulfonate-modified sodium salt, was found to
biodegrade with a half life of 30 days. For comparison in the same
study, the degradation of closely related WSP material, hydrolyzed
polyvinyl acetate, for which an exemption from tolerance is already
established, was determined. This polymer was found to degrade with a
half life of 12 days. Aniline was used as a reference (positive
control) and found to degrade with a half life of around 5 days.
In the study, biological oxygen demand (B.O.D.) of a water solution
of the polymer was used as a measure of the extent of degradation. This
assay measures the total degradation of organic matter in solution.
There was no indication in the study that the biodegradation of the VF-
HP-2 polymer would be less than complete (C CO2, H
H2O, N NO2, S SO3, Na
Na2O), leading to the persistence of any breakdown products.
Complete biodegradation in the environment is a desirable property for
any ingredient in pesticide formulations. After an acclimation period,
the rate of degradation of VF-HP-2 polymer appeared the same as
hydrolyzed polyvinyl acetate, which EPA has already judged to be safe.
It is therefore reasonable to establish an exemption from tolerance for
the VF-HP-2 polymer as WSP for pesticides on the basis that it
otherwise qualifies for the TSCA exemption and is intrinsically safe.
v. High molecular weight, water-absorbing polymers. Water-absorbing
polymers are excluded from eligibility for the amended TSCA exemption.
A water-absorbing polymer is defined as one ``that is capable of
absorbing its own weight of water'' and has a number-average molecular
weight (NAMW) equal to or greater than 10,000. As discussed in the
preamble of the amended polymer exemption rule2, the
exclusion is intended primarily to address concerns for ``super
absorbent'' polymers or ``super slurpers.'' The exclusion responds to
information received under section 8(e) of TSCA for a water-absorbing
polyacrylate. The polymer in question had a NAMW of about 1,000,000 and
could absorb about 100 times its own mass of water. EPA set the
exclusion two orders of magnitude below these levels. ``Super
slurpers'' have the capacity to absorb 60 to 100 times their own mass
of water, yet not dissolve. Clearly, polyvinyl acetate, sulfoxyl group
modified, sodium salt does not fall within this exclusion because it
dissolves in water rather than absorbing it3.
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\2\ 60 FR 16319-16320 March 29, 1995.
\3\ In the Federal Register notice that established a broad
generic exemption from tolerance for acrylate polymers, described
earlier in this volumn, EPA'S Office of Pesticide Programs stated:
``Water soluble (sic) polymers in this molecular weight range
>10,000 daltons are excluded from the exemption under Sec.
723.250(d)....'' 61 FR 6550-6551. The second time in the same notice
that EPA/OPP mentions these polymers, they are called ``highly
water-obsorbing'', a correct interpretation of the exclusion. Water-
obsorbing polymers are not water-soluble.
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3. Conditions: 40 CFR 723.250(e)--i. Polymers of 1,000 < molecular
weight <10,000. To qualify for the exemption, polymers in the molecular
weight range, 1,000 < MW <10,000 must also always have a molecular
weight distribution such that there is less than 25 weight percent with
molecular weights below 1,000 and less than 10 weight percent with
molecular weights below 500. Both criteria must be simultaneously met.
In addition, polymers that meet the molecular weight conditions of 40
CFR 723.250(e)(1) are subject to important reactive functional group
limitations.
Polyvinyl acetate, sulfoxyl group modified, sodium salt has a
number average molecular weights above 10,000 and does not fall within
the condition in 40 CFR 723.250(e)(1).
ii. Polymers with molecular weight > 10,000. Polymers with
molecular weights of 10,000 or greater must have oligomer contents of
less than five weight percent with molecular weights less than 1,000
and less than two weight percent with molecular weights less than 500.
The properties of polyvinyl acetate, sulfoxyl group modified, sodium
salt, supported by GPC molecular weight data, satisfies this condition,
as summarized below:
Typical number-average molecular weight = 62,800
Maximum oligomer contents = 0.0% < 500, 0.0% < 1,000
F. Conclusions on the TSCA Polymer Exemption Criteria
Based on conformance to the criteria described above for TSCA
polymer exemption, a chemical can be anticipated to have no mammalian
toxicity from dietary, inhalation or dermal exposure. The polyvinyl
acetate, sulfoxyl group modified, sodium salt polymer, polyvinyl
acetate, hydrolyzed, sulfonate-modified sodium salt, conforms with all
the criteria except that is biodegradable. This characteristic of
biodegradability is not anticipated to have any impact on mammalian
toxicity from dietary, inhalation or dermal exposure, but rather is a
factor which serves to diminish the possibility of exposure. It is
noted that a closely related WSP polymer for which an exemption from
tolerance has already been established, polyvinyl acetate,
hydrolyzed4, CASRN 25213-24-5, is also biodegradable.
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\4\ 49 FR 46066 November 21, 1984.
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Based on the conformance of polyvinyl acetate, sulfoxyl group
modified, sodium salt to the definition of a polymer given in 40 CFR
723.250(b), as well as the criteria that
[[Page 3096]]
are used to identify low risk polymers, EPA can conclude that there is
a reasonable certainty that no harm to the U.S. population will result
from non-dietary exposures to it.
G. International Tolerances
There are no Codex Alimentarius Commission (Codex), Canadian or
Mexican residue limits for polyvinyl acetate, sulfoxyl group modified,
sodium salt.
[FR Doc. 99-1250 Filed 1-19-99; 8:45 am]
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