[Federal Register Volume 63, Number 87 (Wednesday, May 6, 1998)]
[Rules and Regulations]
[Pages 24936-24939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11765]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300649; FRL-5787-9]
RIN 2070-AB78


Various Inert Ingredients; Tolerance Exemptions

AGENCY: Environmental Protection Agency (EPA).


ACTION: Final rule.

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SUMMARY: This regulation establishes exemptions from the requirement of 
a tolerance exemptions for residues of 2-

[[Page 24937]]

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 establishing this regulation on its own initiative.


DATES: This regulation is effective May 6, 1998. Objections and 
requests for hearings must be received by EPA on or before July 6, 
1998.

ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300649], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300649], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [email protected]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300649]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.


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 address: Crystal Mall #2, 1921 Jefferson 
Davis Hwy., Arlington, VA, (703) 308-8380, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of October 1, 1997 
(62 FR 51397) (FRL-5746-3), EPA proposed the establishment of an 
exemption 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, raw agricultural commodities 
after harvest and/or animals on its own initiative pursuant to section 
408(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(e). This proposal noted that these chemicals were the 
subject of proposed rules published prior to the enactment of the Food 
Quality Protection Act of 1996. Summaries of each of those initial 
proposed rules were also included. There were no comments received in 
response to the proposed rule.
    Based on the information and data considered and the findings set 
forth in the preamble to the proposed rule, EPA is establishing 
exemptions from the requirement of a tolerance as set forth in this 
document.

I. Objections and Hearing Requests

    The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by July 6, 1998, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the information 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.

II. Public Docket

    EPA has established a record for this rulemaking under docket 
control number [OPP-300649] (including any comments and data submitted 
electronically). 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 public 
record is located in Room 119 of the Public Information and Records 
Integrity Branch, Information Resources and Services Division (7502C), 
Office of Pesticide Programs, Environmental Protection Agency, Crystal 
Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
    Electronic comments may be sent directly to EPA at:
    [email protected].



[[Page 24938]]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption.
    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.

III. Regulatory Assessment Requirements

    This final rule establishes an exemption from the requirement of a 
tolerance under section 408(d) of the FFDCA in response to a petition 
submitted to the Agency. 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). This final 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 
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 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).
    The Regulatory Flexibility Act (RFA) 5 U.S.C. 605(b), as amended, 
Pub. L. 104-121, 110 Stat. 847, generally requires an agency to prepare 
a regulatory flexibility analysis of the impact of any notice and 
comment rulemaking on small entities unless the agency certifies that 
the rule will not have a significant economic impact on a substantial 
number of small entities. Small entities include small businesses, 
small not-for-profit enterprises, and small governmental jurisdictions. 
The Agency has 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. Therefore, 
pursuant to section 605(b) of the RFA, EPA certifies that this rule 
will not have a significant economic impact on a substantial number of 
small entities. Accordingly, no final regulatory flexibility analysis 
under section 604(a) of the Act is required.

IV. 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: April 22, 1998.

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180-- [AMENDED]

    1. The authority citation for part 180 continues 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'' to read as 
follows:


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.                                                                
                                                                        

[[Page 24939]]

                                                                        
*                *            *                *                *       
                                *                *                      
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           
 No. 26160-96-3), minimum                         surfactants and       
 number-average molecular                         binder.               
 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.                                                            
                                                                        
*                *            *                *                *       
                                *                *                      
------------------------------------------------------------------------

[FR Doc. 98-11765 Filed 5-5-98; 8:45 am]
BILLING CODE 6560-50-F