[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]
BILLING CODE 6560-50-F