[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