[Federal Register Volume 63, Number 111 (Wednesday, June 10, 1998)]
[Rules and Regulations]
[Pages 31642-31645]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15174]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-300656; FRL-5789-7]
RIN 2070-AB78


Polyvinyl Chloride; Tolerance Exemption

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of polyvinyl chloride when used as an inert 
ingredient carrier in pesticide formulations applied to growing crops 
or raw agricultural commodities after harvest. American Cyanamid 
Company requested this exemption from the requirement of a tolerance 
under the Federal Food, Drug and Cosmetic Act (FFDCA), as amended by 
the Food Quality Protection Act of 1996 (Pub. L. 104-170).

DATES: This regulation is effective June 10, 1998. Objections and 
requests for hearings must be received by EPA on or before August 10, 
1998.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, OPP-300656, 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-300656, 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-300656. 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: Fourth Floor, CS#1, 2800 Crystal 
Drive, Arlington, VA, (703) 308-8380, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION: In the Federal Register of August 29, 1997 
(62 FR 45804) (FRL-5738-2), EPA issued a notice pursuant to section 408 
of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) 
announcing the filing of pesticide petition (PP) 3E4246 for a tolerance 
exemption by American Cyanamid Company, Agricultural Products Research 
Division, P.O. Box 400, Princeton, NJ 08543-0400. This notice included 
a summary of the petition prepared by American Cyanamid Company, the 
petitioner. There were no comments received in response to the notice 
of filing.
    The petition requested that 40 CFR 180.1001 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of polyvinyl chloride when used as an inert ingredient carrier 
in pesticide formulations applied to growing crops or raw agricultural 
commodities after harvest.

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

[[Page 31643]]

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 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; surfactant 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 nonoccupational 
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(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action. EPA has sufficient data to assess the hazards of polyvinyl 
chloride and to make a determination on aggregate exposure, consistent 
with section 408(b)(2), for a tolerance exemption for residues on 
polyvinyl chloride on growing crops and raw agricultural commodities 
after harvest. 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) (FRL-3190-1), 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. Polyvinyl chloride (PVC) conforms to the definition 
of polymer given in 40 CFR 723.250(b) and meets the following criteria 
that are used to identify low risk polymers:
    1.   PVC is not a cationic polymer, nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2.   PVC contains as an integral part of its composition the atomic 
elements carbon, chlorine, and hydrogen.
    3.   PVC does not contain as an integral part of its composition, 
except as impurities, any elements other than those listed in 40 CFR 
section 723.250 (d)(2)(ii).
    4.   PVC is not designed, nor is it reasonably anticipated to 
substantially degrade, decompose, or depolymerize.
    5.   PVC is not manufactured or imported from monomers and/or other 
reactants that are not already included on the Toxic Substance Control 
Act (TSCA) Chemical Substance Inventory or manufactured under an 
applicable TSCA section 5 exemption.
    6.   PVC is not a water absorbing polymer.
    7.   PVC does not contain any group as reactive functional groups.
    8.   The minimum number-average molecular weight of PVC is listed 
as 29,000 daltons. Substances with molecular weights greater than 400 
generally are not absorbed through the intact skin, and substances with 
molecular weights 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.
    9.   PVC has a minimum number-average molecular weight of 29,000 
and contains less than 2 percent oligomeric material below molecular 
weight 500 and less than 5 percent oligomeric material below 1,000 
molecular weight.
    In addition, PVC is approved by the Food and Drug Administration 
(FDA) under 21 CFR for contact with food as a component in adhesives 
(21 CFR 175.105), coatings (21 CFR 175.320), and paper and paperboard 
(21 CFR 176.180). PVC is also approved by FDA as an indirect food 
additive used as a basic component of acrylic (21 CFR 177.1010) and 
cellophane (21 CFR 177.1200) polymers. PVC is also cleared for use as 
water pipe for potable water as per FFDCA 201(s).
    Based on the conformance of polyvinyl chloride to the above 
criteria, no mammalian toxicity is anticipated from dietary, inhalation 
or dermal exposure to polyvinyl chloride.

B. Exposures and Risks

    1. From food and feed uses, drinking water, and non-dietary 
exposures. For the purposes of assessing the potential

[[Page 31644]]

dietary exposure, EPA considered that under this tolerance exemption 
polyvinyl chloride 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 this 
chemical's categorization as a polymer 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 common mechanism of 
toxicity. Section 408(b)(2)(D)(v) requires that, when considering 
whether to establish, modify, or revoke a tolerance, the Agency 
consider ``available information'' concerning the cumulative effects of 
a particular pesticide's residues and ``other substances that have a 
common mechanism of toxicity.''
    In the case of polyvinyl chloride, the lack of expected toxicity of 
this substance 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.

C. Aggregate Risks and Determination of Safety for U.S. Population

    Based on this chemical's 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 polyvinyl chloride. EPA believes this compound 
presents 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 database unless EPA determines 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 use of a 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 chloride, EPA has not 
used a safety factor analysis in assessing the risk of this compound. 
For the same reasons the additional safety factor is unnecessary.

V. Other Considerations

    The Agency proposes to establish an exemption 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 polyvinyl chloride.
    There are no Codex Alimentarius Commission (Codex), Canadian or 
Mexican residue limits for polyvinyl chloride.

VI. Conclusion

    Therefore, an exemption from the requirement of a tolerance is 
established for residues of polyvinyl chloride.

VII. 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 August 10, 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 
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 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.

VIII. Public Record and Electronic Submissions

    EPA has established a record for this rulemaking under docket 
control number [OPP-300656] (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 Rm. 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 Highway, Arlington, VA.
    Electronic comments may 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.
    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.

[[Page 31645]]

IX. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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 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.

X. Submission to Congress and the General Accounting Office

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit 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 United States prior 
to publication of the rule in the Federal Register. This rule 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 record 
keeping requirements.

    Dated: May 21, 1998.

James Jones,
Director, Registration Division, Office of Pesticide Programs.

PART 180 -- [AMENDED]

    Therefore, 40 CFR chapter I is amended as follows:
    1. The authority citation for part 180 continues to read as 
follows:

    Authority: 21 U.S.C. 346a and 371.

    2. In section 180.1001 the table in paragraph (c) is amended by 
adding alphabetically the following inert ingredient to read as 
follows:


Sec. 180.1001 Exemption from the requirement of a tolerance.  

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    (c)      *      *      *


                                                                        
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        Inert ingredients               Limits               Uses       
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                       *    *    *    *    *    *    *                  
Polyvinyl chloride (CAS Reg. No.    ................  Carrier           
 9002-86-2), minimum number                                             
 average molecular weight (in                                           
 amu) 29,000.                                                           
                       *    *    *    *    *    *    *                  
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[FR Doc. 98-15174 Filed 6-9-98; 8:45 am]
BILLING CODE 6560-50-F