[Federal Register Volume 62, Number 190 (Wednesday, October 1, 1997)]
[Proposed Rules]
[Pages 51397-51402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-26015]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[OPP-300558; FRL-5746-3]
RIN 2070-AC18
Various Inert Ingredients; Tolerance Exemptions
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed Rule.
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SUMMARY: EPA proposes to establish exemptions from the requirement of a
tolerance for residues of 2-propene-1-sulfonic acid, sodium salt,
polymer with ethenol and ethenyl acetate; polyvinyl pyrrolidone
butylated polymer; vinyl pyrrolidone-acrylic acid copolymer; maleic
anhydride-diisobutylene copolymer, sodium salt; vinyl alcohol-vinyl
acetate copolymer, benzaldehyde-o-sodium sulfonate condensate when used
as inert ingredients in pesticide formulations applied to growing
crops, crops after harvest, and/or animals. EPA is proposing this
regulation on its own initiative.
DATES: Comments, identified by the docket control number [OPP-300558],
must be received on or before December 1, 1997.
ADDRESSES: By mail, submit written comments to: Public Information and
Records Integrity Branch, Information Resources and Services Division
(7506C), Office of Pesticide Programs, Environmental Protection Agency,
401 M St., SW., Washington, DC 20460. In person, deliver comments to:
Rm. 1132, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
[[Page 51398]]
Comments and data may also be submitted electronically to: opp-
[email protected]. Follow the instructions under Unit VII of this
document. No Confidential Business Information (CBI) 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). Information so marked 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 will be included in the public docket by EPA without prior
notice. The public docket is available for public inspection in Rm.
1132 at the Virginia address given above, from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: By mail: Bipin Gandhi, Registration
Division (7505W), Office of Pesticide Programs, Environmental
Protection Agency, 401 M St., SW., Washington, DC 20460. Office
location, telephone number and e-mail: Fourth Floor, CS #1, 2800
Crystal Drive, Arlington, VA, (703) 308-8380; e-mail:
[email protected].
SUPPLEMENTARY INFORMATION: Prior to the enactment of the Food Quality
Protection Act of 1996 (FQPA), EPA proposed that exemptions from the
requirement of a tolerance be established for residues of 2-propene-1-
sulfonic acid, sodium salt, polymer with ethenol and ethenyl acetate;
polyvinyl pyrrolidone butylated polymer; vinyl pyrrolidone-acrylic acid
copolymer; maleic anhydride-diisobutylene copolymer, sodium salt; vinyl
alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate
condensate in response to various pesticide petitions submitted
pursuant to section 408(e) of the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 346a(e). Each of these proposals is summarized at
the end of this section.
Pursuant to section 408(e)(1)(B) of FFDCA, the Agency is
reproposing upon its own initiative the following tolerance exemptions
in view of the new FQPA amendments to the FFDCA.
1. 2-propene-1-sulfonic acid, sodium salt, polymer with ethenol and
ethenyl acetate. In the Federal Register of May 16, 1996 (61 FR
24738)(FRL-5365-3), EPA proposed that an exemption from the requirement
of a tolerance be established for residues of 2-propene-1-sulfonic
acid, sodium salt, polymer with ethenol and ethenyl acetate (CAS Reg.
No. 107568-10-5) when used as an inert ingredient (binding agent) in
pesticide formulations applied to growing crops, raw agricultural
commodities after harvest, and animals. This proposed rule was issued
in response to pesticide petition (PP) 5E04568 submitted by Japan
Technical Information Center on behalf of Nippon Goshei (U.S.A.) Co.,
Ltd., 775 South 23rd Street, Arlington, VA 22202. No comments were
received in response to the proposed rule.
2. Polyvinyl pyrrolidone butylated polymer. In the Federal Register
of July 10, 1996 (61 FR 36331)(5380-5), EPA proposed that an exemption
from the requirement of a tolerance be established for residues of
polyvinyl pyrrolidone butylated polymer (CAS Reg No. 26160-96-3) when
used as an inert ingredient (surfactants, related adjuvant of
surfactants and binder) in pesticide formulations applied to growing
crops, raw agricultural commodities after harvest, and animals. This
proposed rule was issued in response to pesticide petition (PP) 6E4644
submitted by International Specialty Products, 1361 Alps Road, Wayne,
NJ 07470. No comments were received in response to the proposed rule.
3. Vinyl pyrrolidone-acrylic acid copolymer. In the Federal
Register of June 14, 1996 (61 FR 30202)(FRL-5374-4), EPA proposed that
an exemption from the requirement of a tolerance be established for
residues of vinyl pyrrolidone-acrylic acid copolymer when used as an
inert ingredient (adhesive, dispersion stabilizer and coating for
sustained release granules) in pesticide formulations applied to
growing crops, raw agricultural commodities after harvest, and animals.
This proposed rule was issued in response to pesticide petition (PP)
6E4659 submitted by International Specialty Products, 1361 Alps Road,
Wayne, NJ 07470. No comments were received in response to the proposed
rule.
4. Maleic anhydride-diisobutylene copolymer, sodium salt. In the
Federal Register of July 10, 1996 (61 FR 36329)(FRL-5374-3), EPA
proposed that an exemption from the requirement of a tolerance be
established for residues of maleic anhydride-diisobutylene copolymer,
sodium salt (CAS Reg. No. 37199-81-8) when used as an inert ingredient
(suspending agent and dispersing agent) in pesticide formulations
applied to growing crops, raw agricultural commodities after harvest,
and animals. This proposed rule was issued in response to pesticide
petition (PP) 6E4665 submitted by Rhone-Poulenc North America Chemicals
Inc., CN 5255, Princeton, NJ 08543-5255. A comment was received in
response to the proposal that stated the proposed deletion of the
tolerance exemption for growing crops only under 40 CFR 180.1001(d) for
maleic anhydride-diisobutylene copolymer, sodium salt needed to be
accompanied by an adjustment in the molecular weight range proposed for
maleic anhydride-diisobutylene copolymer, sodium salt under 40 CFR
180.1001(c) and (e) to allow for the other permissible molecular
weights of maleic anhydride-diisobutylene copolymer, sodium salt
polymers. The Agency agrees with the commentor and has revised the
proposed molecular weight range of maleic anhydride-diisobutylene
copolymer, sodium salt accordingly.
5. Vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium
sulfonate condensate. In the Federal Register of July 18, 1996 (61 FR
37433) (FRL-5376-4), EPA proposed that an exemption from the
requirement of a tolerance be established for residues of vinyl
alcohol-vinyl acetate copolymer, benzaldehyde-o-sodium sulfonate
condensate when used as an inert ingredient (water soluble resin) in
pesticide formulations applied to growing crops, raw agricultural
commodities after harvest, and animals. This proposed rule was issued
in response to pesticide petition (PP) 6E4718 submitted by Mitsui
Plastics, Inc., 11 Martine Ave., White Plains, NY 10606. No comments
were received in response to the proposed rule.
I. Background and Statutory Authority
The Food Quality Protection Act of 1996 (FQPA) (Pub. L. 104-170)
was signed into law August 3, 1996. FQPA amends both the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 301 et seq., and the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. The FQPA amendments went into effect immediately. Among other
things, FQPA amends FFDCA to bring all EPA pesticide tolerance-setting
activities under a new section 408 with a new safety standard and new
procedures.
New section 408(c)(2)(A)(i) allows EPA to establish an exemption
from the requirement of a tolerance for a pesticide chemical residue on
food only if EPA determines that the exemption is ``safe.'' Section
408(c)(2)(A)(ii) defines ``safe'' to mean that ``there is a reasonable
certainty that no harm will result from aggregate exposure to the
pesticide chemical residue, including all anticipated dietary exposures
and all other exposures for which there is
[[Page 51399]]
reliable information.'' This includes exposure through drinking water,
but does not include occupational exposure. Section 408(c)(2)(B)
requires EPA to give special consideration to exposure of infants and
children to the pesticide chemical residue in establishing an exemption
from the requirement of tolerance and to ``ensure that there is a
reasonable certainty that no harm will result to infants and children
from aggregate exposure to the pesticide chemical residue'' and
specifies factors EPA is to consider in establishing an exemption.
II. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
III. Risk Assessment and Statutory Findings
EPA establishes exemptions from the requirement of a tolerance
only in those cases where it can be clearly demonstrated that the risks
from aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert ingredient in conjunction with possible exposure to residues of
the inert ingredient in food, drinking water, and other non-
occupational exposures. If EPA is able to determine that a finite
tolerance is not necessary to ensure that there is a reasonable
certainty that no harm will result from aggregate exposure to the inert
ingredient, an exemption from the requirement of a tolerance may be
established.
IV. Aggregate Risk Assessment and Determination of Safety
Consistent with section 408(c)(2)(B) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
the proposed actions. EPA has sufficient data to assess the hazards of
2-propene-1-sulfonic acid, sodium salt, polymer with ethenol and
ethenyl acetate; polyvinyl pyrrolidone butylated polymer; vinyl
pyrrolidone-acrylic acid copolymer; maleic anhydride-diisobutylene
copolymer, sodium salt; and vinyl alcohol-vinyl acetate copolymer,
benzaldehyde-o-sodium sulfonate and to make a determination on
aggregate exposure, consistent with section 408(b)(2), for tolerance
exemptions for the residues of 2-propene-1-sulfonic acid, sodium salt,
polymer with ethenol and ethenyl acetate; polyvinyl pyrrolidone
butylated polymer; vinyl pyrrolidone-acrylic acid copolymer; maleic
anhydride-diisobutylene copolymer, sodium salt; and vinyl alcohol-vinyl
acetate copolymer, benzaldehyde-o-sodium sulfonate condensate on
growing crops, raw agricultural commodities after harvest and animals.
EPA's assessment of the dietary exposures and risks associated with
establishing these tolerances follows.
The data submitted in the petitions and other relevant material
have been evaluated. As part of the EPA policy statement on inert
ingredients published in the Federal Register of April 22, 1987 (52 FR
13305), 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
that 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.
A. Toxicological Profile
In the case of certain chemical substances that are defined as
``polymers,'' the Agency has established a set of criteria which
identify categories of polymers that present low risk. These criteria
(described in 40 CFR 723.250) identify polymers that are relatively
unreactive and stable compared to other chemical substances as well as
polymers that typically are not readily absorbed. These properties
generally limit a polymer's ability to cause adverse effects. In
addition, these criteria exclude polymers about which little is known.
The Agency believes that polymers meeting these criteria will present
minimal or no risk. 2-Propene-1-sulfonic acid, sodium salt, polymer
with ethenol and ethenyl acetate; polyvinyl pyrrolidone butylated
polymer; vinyl pyrrolidone-acrylic acid copolymer; maleic anhydride-
diisobutylene copolymer, sodium salt; and vinyl alcohol-vinyl acetate
copolymer, benzaldehyde-o-sodium sulfonate condensate, all conform to
the definition of a polymer given in 40 CFR 723.250(b) and meet the
following criteria that are used to identify low risk polymers:
1. They are not cationic polymers, nor is it reasonably
anticipated they will become cationic polymers in a natural aquatic
environment.
2. They contain as an integral part of their composition the atomic
elements carbon, hydrogen, and oxygen.
3. They do not contain as an integral part of their composition,
except as impurities, any elements other than those listed in 40 CFR
723.250(d)(2)(ii).
4. They are not designed, nor are they reasonably anticipated to
substantially degrade, decompose or depolymerize.
5. They are not manufactured or imported from monomers and/or other
reactants that are not already included on the TSCA Chemical Substance
Inventory or manufactured under an applicable TSCA section 5 exemption.
6. They are not water absorbing polymers.
7. The minimum number-average molecular weight of each of the above
polymers is greater than 1,000 daltons. Substances with molecular
weights (MW) greater than 400 generally are not absorbed through the
intact skin, and substances with MW greater than 1,000 generally are
not absorbed through the intact gastrointestinal (GI) tract. Chemicals
not absorbed through the skin or GI tract generally are incapable of
eliciting a toxic response.
8. Each of the above-listed polymers has an oligomer content less
than 2 percent below MW 500 and less than 5 percent MW 1,000.
Based on these chemicals' conformance to the above criteria, no
mammalian toxicity is anticipated from dietary, inhalation or dermal
exposure to 2-propene-1-sulfonic acid, sodium salt, polymer with
ethenol and ethenyl acetate; polyvinyl pyrrolidone butylated polymer;
vinyl pyrrolidone-acrylic acid copolymer; maleic anhydride-
diisobutylene copolymer, sodium salt; and vinyl alcohol-vinyl acetate
copolymer, benzaldehyde-o-sodium sulfonate condensate.
[[Page 51400]]
B. Exposures and Risks
1. From food and feed uses, drinking water, and non-dietary
exposures. For the purposes of assessing the potential dietary exposure
under these exemptions, EPA considered that under these exemptions 2-
propene-1-sulfonic acid, sodium salt, polymer with ethenol and ethenyl
acetate; polyvinyl pyrrolidone butylated polymer; vinyl pyrrolidone-
acrylic acid copolymer; maleic anhydride-diisobutylene copolymer,
sodium salt; and vinyl alcohol-vinyl acetate copolymer, benzaldehyde-o-
sodium sulfonate condensate could be present in all raw and processed
agricultural commodities and drinking water and that non-occupational,
non-dietary exposure was possible. EPA concluded that, based on these
chemicals' categorization as polymers conforming to the definition of a
polymer under 40 CFR 723.250(b) that also meet the criteria used to
identify low risk polymers, there are no concerns for risks associated
with any potential exposure scenarios that are reasonably foreseeable.
2. Cumulative exposure to substances with a common mechanism of
toxicity. 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 2-propene-1-sulfonic acid, sodium salt, polymer with
ethenol and ethenyl acetate; polyvinyl pyrrolidone butylated polymer;
vinyl pyrrolidone-acrylic acid copolymer; maleic anhydride-
diisobutylene copolymer, sodium salt; and vinyl alcohol-vinyl acetate
copolymer, benzaldehyde-o-sodium sulfonate condensate, the lack of
expected toxicity of these substances based on their 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.
C. Aggregate Risks and Determination of Safety for U.S. Population
Based on these chemicals' conformance 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 concludes that there is a
reasonable certainty that no harm to the U.S. population will result
from aggregate exposure to 2-propene-1-sulfonic acid, sodium salt,
polymer with ethenol and ethenyl acetate; polyvinyl pyrrolidone
butylated polymer; vinyl pyrrolidone-acrylic acid copolymer; maleic
anhydride-diisobutylene copolymer, sodium salt; and vinyl alcohol-vinyl
acetate copolymer, benzaldehyde-o-sodium sulfonate condensate. EPA
believes these compounds present no dietary risk under reasonably
foreseeable circumstances.
D. Aggregate Risks and Determination of Safety for 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 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 these compounds, EPA has not
used a safety factor analysis in assessing the risk of these compounds.
For the same reasons the additional safety factor is unnecessary.
V. Other Considerations
The Agency proposes to establish exemptions from the requirement of
a tolerance without any numerical limitation; therefore, the Agency has
concluded that analytical methods are not required for enforcement
purposes for 2-propene-1-sulfonic acid, sodium salt, polymer with
ethenol and ethenyl acetate; polyvinyl pyrrolidone butylated polymer;
vinyl pyrrolidone-acrylic acid copolymer; maleic anhydride-
diisobutylene copolymer, sodium salt; and vinyl alcohol-vinyl acetate
copolymer, benzaldehyde-o-sodium sulfonate condensate.
There are no Codex Alimentarius Commission (Codex), Canadian or
Mexican residue limits for 2-propene-1-sulfonic acid, sodium salt,
polymer with ethenol and ethenyl acetate; polyvinyl pyrrolidone
butylated polymer; vinyl pyrrolidone-acrylic acid copolymer; maleic
anhydride-diisobutylene copolymer, sodium salt; and vinyl alcohol-vinyl
acetate copolymer, benzaldehyde-o-sodium sulfonate condensate.
VI. Conclusion
Based on the information and data considered, EPA proposes that the
exemptions from the requirement of a tolerance be established as set
forth in this document.
VII. Public Record and Electronic Submissions
Under FFDCA 408(e)(2), EPA must provide for a public comment period
before issuing a final tolerance or tolerance exemption under
408(e)(1). Interested persons are invited to submit written comments on
the proposed regulation. Comments must bear a notation indicating the
docket control number, [OPP-300558]. All written comments filed in
response to this petition will be available in the Public Information
and Records Integrity Branch at the Virginia address given above from
8:30 a.m. to 4 p.m. Monday through Friday, except legal holidays.
The official record for this rulemaking, as well as the public
version, has been established for this rulemaking under docket control
number [OPP-300558] (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 rulemaking record is located at the Virginia
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 file format or ASCII
file format. All comments and data in electronic form must be
identified by the docket control number [OPP-300558]. Electronic
comments on this proposed rule may be filed online at many Federal
Depository Libraries.
VIII. Regulatory Assessment Requirements
This action proposes an exemption from the tolerance requirement
under FFDCA section 408(e). The Office of Management and Budget (OMB)
has exempted these types of actions from review under Executive Order
12866, entitled Regulatory Planning and Review (58 FR 51735, October 4,
1993). In addition, this proposed rule does not contain any information
collections subject to OMB approval under the Paperwork Reduction Act
(PRA), 44 U.S.C. 3501 et seq., or impose any enforceable duty or
contain any
[[Page 51401]]
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does it require any
prior consultation as specified by Executive Order 12875, entitled
Enhancing the Intergovernmental Partnership (58 FR 58093, October 28,
1993), or special considerations as required by Executive Order 12898,
entitled Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations (59 FR 7629, February 16, 1994),
or require special OMB review in accordance with Executive Order 13045,
entitled Protection of Children from Environmental Health Risks and
Safety Risks (62 FR 19885, April 23, 1997).
In addition, under the Regulatory Flexibility Act (RFA) (5 U.S.C.
601 et seq.), the Agency previously assessed whether establishing
tolerances, exemptions from tolerances, raising tolerance levels or
expanding exemptions might adversely impact small entities and
concluded, as a generic matter, that there is no adverse economic
impact. The factual basis for the Agency's generic certification for
tolerance actions published on May 4, 1981 (46 FR 24950), and was
provided to the Chief Counsel for Advocacy of the Small Business
Administration.
IX. Submission to Congress and the General Accounting Office
Under 5 U.S.C. 801(a)(1)(A), as added by the Small Business
Regulatory Enforcement Fairness Act of 1996, the Agency has submitted a
report containing this rule and other required information to the U.S.
Senate, the U.S. House of Representatives, and the Comptroller General
of the General Accounting Office prior to publication of this rule in
today's Federal Register. This is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural Commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 24, 1997.
James Jones,
Acting Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PART 180--[AMENDED]
1. The authority citation for part 180 is revised to read as
follows:
Authority: 21 U.S.C. 346a and 371.
2. In Sec. 180.1001 the tables in paragraphs (c) and (e) are
amended by adding alphabetically the following inert ingredients, and
the table in paragraph (d) is amended by removing the entry for
``Maleic anhydride diisobutylene copolymer, sodium salt.''
Sec. 180.1001 Exemptions from the requirements of a tolerance.
* * * * *
(c) * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
Maleic anhydride- Suspending agent and
diisobutylene copolymer, dispersing agent.
sodium salt (CAS Reg. No.
37199-81-8), minimum number
average molecular weight (in
amu) 5,000-18,000.
* * * * *
Polyvinylpyrrolidone Surfactants, related
butylated polymer (CAS Reg adjuvant of surfactants
No. 26160-96-3), minimum and binder.
number average molecular
weight (in amu) 9,500.
* * * * *
2-Propene-1-sulfonic acid Binding Agent.
sodium salt, polymer with
ethenol and ethenyl acetate,
number average molecular
weight (in amu) 6,000 -
12,000.
* * * * *
Vinyl alcohol-vinyl acetate Water soluble resin.
copolymer, benzaldehyde-o-
sodium sulfonate condensate,
minimum number average
molecular weight (in amu)
20,000.
* * * * *
Vinyl pyrrolidone-acrylic Adhesive, dispersion
acid copolymer (CAS Reg. No. stabilizer and coating
28062-44-4), minimum number for sustained release
average molecular weight (in granules.
amu) 6,000.
* * * * *
------------------------------------------------------------------------
* * * * * * *
(e) * * *
------------------------------------------------------------------------
Inert ingredients Limits Uses
------------------------------------------------------------------------
* * * * *
Maleic anhydride- Suspending agent and
diisobutylene copolymer, dispersing agent.
sodium salt (CAS Reg. No.
37199-81-8), minimum number
average molecular weight (in
amu) 5,000-18,000.
* * * * *
Polyvinylpyrrolidone Surfactants, related
butylated polymer (CAS Reg adjuvant of surfactants
No. 26160-96-3), minimum and binder.
number-average molecular
weight (in amu) 9,500.
* * * * *
2-Propene-1-sulfonic acid Binding Agent.
sodium salt, polymer with
ethenol and ethenyl acetate,
number average molecular
weight (in amu) 6,000 -
12,000.
[[Page 51402]]
* * * * *
Vinyl alcohol-vinyl acetate Water soluble resin.
copolymer, benzaldehyde-o-
sodium sulfonate condensate,
minimum number average
molecular weight (in amu)
20,000.
* * * * *
Vinyl pyrrolidone-acrylic, Adhesive, dispersion
acid copolymer (CAS Reg. No. stabilizer and coating
28062-44-4), minimum number for sustained release
average molecular weight (in granules.
amu) 6,000.
* * * * *
------------------------------------------------------------------------
[FR Doc.97-26015 Filed 9-30-97; 8:45 am]
BILLING CODE 6560-50-F