[Federal Register Volume 64, Number 12 (Wednesday, January 20, 1999)]
[Notices]
[Pages 3096-3098]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1251]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[PF-839; FRL-6038-2]
Kuraray America, Inc.; Pesticide Tolerance Petition Filing
AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice.
-----------------------------------------------------------------------
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-839, 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: 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-839] (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-839) 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 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.
Kuraray America, Inc.
PP 8E4944
EPA has received a pesticide petition (PP 8E4944) 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 to establish an
exemption from the requirement of a tolerance as a pesticide inert
ingredient in or on raw agricultural commodities for polyvinyl acetate,
carboxyl-modified, sodium salt (Vinylon VF-HH-4) 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, carboxyl-modified, sodium salt conforms to the
definition of polymer given in 40 CFR 723.250(b).
1. Polyvinyl acetate, carboxyl-modified, sodium salt is not
cationic or potentially cationic.
2. Polyvinyl acetate, carboxyl-modified, sodium salt contains as an
intergral 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.
[[Page 3097]]
3. Polyvinyl acetate, carboxyl-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, carboxyl-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.="" polyvinyl="" acetate,="" carboxyl-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="" 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,="" carboxyl-modified,="" sodium="" salt="" does="" not="" fall="" within="" this="" exclusion="" because="" it="" dissolves="" in="" water="" rather="" than="" absorbing="" it.="" b.="" aggregate="" exposure="" the="" agency="" has="" maintained="" that="" polymers="" meeting="" the="" polymer="" exemption="" criteria="" (as="" described="" previously="" for="" polyvinyl="" acetate,="" carboxyl-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,="" carboxyl-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.="" based="" on="" conformance="" to="" the="" criteria="" for="" tsca="" polymer="" exemption,="" a="" chemical="" can="" be="" anticipated="" to="" have="" no="" mammalian="" toxicity="" from="" dietary,="" inhalation="" or="" dermal="" exposure.="" the="" polymer,="" polyvinyl="" acetate,="" hydolyzed,="" carboxyl-modified,="" sodium="" salt,="" conforms="" with="" all="" the="" criteria.="" 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,="" carboxyl-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="" premanufacturing="" 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,="" carboxyl-="" 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,="" carboxylate-modified="" sodium="" salt="" (polyvinyl="" acetate,="" carboxyl-modified,="" sodium="" salt,="" 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,="" carboxyl-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="" 2%="" 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,="" carboxyl-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,="" carboxyl-="" modified,="" sodium="" salt="" is="" not="" cationic="" or="" potentially="" cationic.="" iii.="" atomic="" element="" limitations.="" the="" exclusion="" at="" 40="" cfr="" 723.250="" (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="" mor="" 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,="" carboxyl-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="" [[page="" 3098]]="" 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="">1. 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.
---------------------------------------------------------------------------
\1\ 49 FR 46066 (November 21, 1984)
---------------------------------------------------------------------------
Kuraray America, Inc. conducted tests on the stability of the VF-
HH-4 polymer and it was found not to biodegradable under the test
conditions.
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, carboxyl-
modified, sodium salt does not fall within this exclusion because it
dissolves in water rather than absorbing it3.
---------------------------------------------------------------------------
\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 volume. 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-absorbing,'' a correct interpretation of the
exclusion. Water-absorbing polymers are not water-soluble.
---------------------------------------------------------------------------
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% with molecular
weights below 1,000 and less than 10% with molecular weights below 500.
Both criteria must be simultaneously met. In addition, polymers that
meet the molecular weight conditions of (e)(1) are subject to important
reactive functional group limitations.
Polyvinyl acetate, carboxyl-modified, sodium salt has a number
average molecular weights above 10,000 and does not fall within
condition (e)(1).
ii. Polymers with molecular weight 10,000. Under
conditions (e)(2), polymers with molecular weights of 10,000 or greater
must have oligomer contents of less than 5% with molecular weights less
than 1,000 and less than 2% with molecular weights less than 500. The
properties of polyvinyl acetate, carboxyl-modified, sodium salt,
supported by GPC molecular weight data, satisfies this condition, as
summarized below:
Typical number-average molecular weight = 52,260
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. In the case of
polyvinyl acetate, carboxyl-modified, sodium salt, polyvinyl acetate,
hydrolyzed, carboxylate-modified sodium salt, conformance with all the
criteria can be demonstrated. Additionally, this substance has been
through the PMN review process and is listed on the TSCA Inventory. It
is noted that an exemption from tolerance has already been established
for a closely related WSP polymer, polyvinyl acetate, hydrolyzed, CASRN
25213-24-5.
Based on the conformance of polyvinyl acetate, carboxyl-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.
G. International Tolerances
There are no Codex Alimentarius Commission (Codex), Canadian or
Mexican residue limits for polyvinyl acetate, carboxyl-modified, sodium
salt.
[FR Doc. 99-1251 Filed 1-19-99; 8:45 am]
BILLING CODE 6560-50-U
