[Federal Register Volume 65, Number 245 (Wednesday, December 20, 2000)]
[Notices]
[Pages 79839-79842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32153]


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ENVIRONMENTAL PROTECTION AGENCY

[PF-987; FRL-6760-6]


Notice of Filing a Pesticide Petition to Establish a Tolerance 
for a Certain Pesticide Chemical in or on Food

AGENCY:  Environmental Protection Agency (EPA).

ACTION:  Notice.

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SUMMARY:  This notice announces the initial filing of a pesticide 
petition proposing the establishment of regulations for residues of a 
certain pesticide chemical in or on various food commodities.

DATES:  Comments, identified by docket control number PF-987, must be 
received on or before January 19, 2001.

ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number PF-987 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Indira Gairola, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-6379; e-mail address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be affected by this action if you are an agricultural 
producer, food manufacturer or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

 
------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
    2. In person. The Agency has established an official record for 
this action under docket control number PF-987. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, and other 
information related to this action, including any information claimed 
as confidential business information (CBI). This official record 
includes the documents that are physically located in the docket, as 
well as the documents that are referenced in those documents. The 
public version of the official record does not include any information 
claimed as CBI. The public version of the official record, which 
includes printed, paper versions of any electronic comments submitted 
during an applicable comment period, is available for inspection in the 
Public Information and Records Integrity Branch (PIRIB), Rm. 119, 
Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number PF-987 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 or ASCII file

[[Page 79840]]

format. All comments in electronic form must be identified by docket 
control number PF-987. Electronic comments may also be filed online at 
many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Make sure to submit your comments by the deadline in this 
notice.
    7. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. What Action is the Agency Taking?

    EPA has received a pesticide petition as follows proposing the 
establishment and/or amendment of regulations for residues of a certain 
pesticide chemical in or on various food commodities under section 408 
of the Federal Food, Drug, and Comestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that this petition contains data or information 
regarding the elements set forth in section 408(d)(2); however, EPA has 
not fully evaluated the sufficiency of the submitted data at this time 
or whether the data support granting of the petition. Additional data 
may be needed before EPA rules on the petition.

List of Subjects

    Environmental protection, Agricultural commodities, Feed additives, 
Food additives, Pesticides and pests, Reporting and recordkeeping 
requirements.


    Dated: December 8, 2000.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summary of Petition

    The petitioner summary of the pesticide petition is printed below 
as required by section 408(d)(3) of the FFDCA. The summary of the 
petition was prepared by the petitioner and represents the view of the 
petitioner. EPA is publishing the petition summary verbatim without 
editing it in any way. The petition summary announces the availability 
of a description of the analytical methods available to EPA for the 
detection and measurement of the pesticide chemical residues or an 
explanation of why no such method is needed.

Miller Chemical and Fertilizer Corporation

PP 1E6239

    EPA has received a pesticide petition (1E6239) from Miller Chemical 
and Fertilizer Corporation, P.O. Box 333, Radio Road, Hanover, PA 17331 
proposing, pursuant to section 408(d) of the (FFDCA), 21 U.S.C. 
346a(d), to amend 40 CFR 180.1001(c) and (e), to establish an exemption 
from the requirement of a tolerance for polybutylene as an inert 
ingredient in or on growing crops or when applied to the raw 
agricultural commodity (RAC) after harvest or when applied to animals. 
EPA has determined that the petition contains data or information 
regarding the elements set forth in section 408(d)(2) of the FFDCA; 
however, EPA has not fully evaluated the sufficiency of the submitted 
data at this time or whether the data support granting of the petition. 
Additional data may be needed before EPA rules on the petition.

A. Toxicological Profile

    As part of the EPA policy statement on inert ingredients published 
in the Federal Register (52 FR 13305, April 22, 1987), 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 the 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. Miller Chemical and Fertilizer Corporation 
believes that the data and the information described below are adequate 
to ascertain the toxicology and characterize the risk associated with 
the use of polybutylene (CAS Reg. No.9003-29-6) as an inert ingredient 
in pesticide formulations applied to growing crops, RACs after harvest, 
and to animals.
    In the case of certain chemical substances that are defined as 
``polymers'' EPA has established a set of criteria which identify 
categories of polymers that present low risk. These criteria (codified 
in 40 CFR 723.250) identify polymers that are relatively unreactive and 
stable compared to other chemical substances as well as polymers that 
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. EPA believes that polymers 
meeting the criteria noted below will present minimal or no risk.
    Polybutylene conforms to the definition of a polymer given in 40 
CFR 723. 250(b) and meets the following criteria that are used to 
identify low risk polymers.
    1. Polybutylene is not a cationic polymer, nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. Polybutylene contains as an integral part of its composition the 
atomic elements carbon and hydrogen.
    3. Polybutylene does not contain as an integral part of its 
composition any elements other those listed in 40 CFR 
723.250(d)(2)(ii).
    4. Polybutylene is not designed, nor is it reasonably anticipated 
to substantially degrade, decompose, or depolymerize.
    5. Polybutylene is not manufactured or imported from monomers and/
or other reactants that are not already included on the Toxic 
Substances Control Act (TSCA) Chemical Substance Inventory or 
manufactured under an applicable TSCA section 5 exemption.

[[Page 79841]]

    6. Polybutylene is not a water absorbing polymer.
    7. Polybutylene does not contain any group as reactive functional 
groups.
    8. The minimum number-average molecular weight of polybutylene is 
listed as 1,330 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 gastrointestincal (GI) tract. Chemicals not absorbed 
through the skin or GI tract generally are incapable of eliciting a 
toxic response.
    9. Polybutylene has a number-average molecular weight of 1,330 and 
contains less than 10% oligomeric material below molecular weight of 
500 and less than 25% oligomeric material below 1,000 molecular weight.
    In addition, polybutylene is approved by the Food and Drug 
Administration (FDA) under 21 CFR for following food contact 
applications:
    a. Polybutylene is cleared for use in contact with food under 21 
CFR 177.1430. The specifications set forth in this regulation for 
isobutylene-butene copolymers include molecular weight range (150-
5,000), viscosity range and maximum bromine values.
    b. Polybutylene is approved under 21 CFR 175.125 for use as a 
component of release coatings on backings or linings for pressure 
sensitive adhesive labels for food contact applications.
    c. Polybutylene is approved under 21 CFR 175.300 for use as a 
component of resinous and polymeric coatings for food contact surfaces.
    d. Polybutylene is approved under 21 CFR 176.170 for use as a 
component of paper and paperboard in contact with aqueous and fatty 
foods.
    e. Polybutylene is approved under 21 CFR 176.180 for use as a 
component of paper and paperboard in contact with dry foods.
    f. Polybutylene is approved under 21 CFR 176.210 for use as a 
defoaming agent in the manufacture of paper and paperboard that come in 
contact with food.
    g. Polybutylene is approved under 21 CFR 177.1520 for use as a 
plasticizer in polyethylene used in the manufacture of articles for 
food contact applications.
    h. Polybutylene is approved under 21 CFR 177.1640 for use as a 
plasticizer in polystyrene used in the manufacture of articles for food 
contact applications.
    i. Polybutylene is approved under 21 CFR 177.2800 for use as a 
component of textiles and textile fibers used in the manufacture of 
articles for food contact applications.
    j. Polybutylene is approved for use in lubricants with incidental 
food contact under 21 CFR 178.3570.
    k. Polybutylene is approved under 21 CFR 178.3710 for use as a 
component of articles that come in contact with food.
    l. Polybutylene is approved under 21 CFR 178.3740 for use as a 
component of articles that come in contact with food.
    The above regulations are applicable to polybutylenes manufactured 
from stisobutylene and n-butene as monomers (complying with 21 CFR 
177.1430). The Food and Drug Administration (FDA) has also approved 
polybutylene for other food contact applications under 21 CFR 175.105, 
21 CFR 177.1420, 177.1520, 177.2260, and 178.3910. In other words, the 
FDA has determined that polybutylenes are safe to use in articles that 
come in contact with food.
    Polybutylene is widely used as a cosmetic ingredient in personal 
care products. The Cosmetic Toiletry and Fragrance Association (CTFA) 
evaluated the safety of polybutene for use in personal care products 
and found that it is safe to use in cosmetic products.
    Polybutylene (CAS Reg. No.9003-29-6) and all components of 
polybutylene are listed on the TSCA Chemical Substances Inventory.
    Polybutenes are exempt from the requirement of a tolerance under 40 
CFR 180.1037 for residues in or on the RAC:
    a. Cottonseed when used as a sticker agent for formulations of the 
attractant gossyplure [1:1 mixture of (Z,Z)-- and (Z,E)-7,11-
hexadecadien-1-ol acetate] to disrupt the mating of the pink bollworm.
    b. Artichokes when used as a sticker agent in multi-layered 
laminated controlled-release dispensers of (Z)-11-hexadecenal to 
disrupt the mating of the artichoke plume moth.

B. Aggregate Exposure:

    Polybutylene and its formulations have been in commerce for more 
than 30 years. The copolymer is ubiquitous in our every day environment 
and it is commonly used in cosmetic formulations (concentrations 
ranging from 1 to >50%), adhesives, caulks, sealants, glazing 
compounds, coatings, lubricants, stretch wrap film, and electrical 
cable insulation.
    Although exposure to polybutylene may occur through dietary (e.g., 
adhesives, lubricants, and food wrappings), and non-occupational (e.g., 
electrical cable insulation) sources, the chemical characteristics of 
polybutylene lead to the conclusion that there is a reasonable 
certainty of no harm from aggregate exposure to this polymer.
    The Agency has maintained that polymers meeting the polymer 
exemption criteria (as described previously for polybutylene) will 
present minimal risk to human health when used as inert ingredients in 
pesticide products applied to food crops. EPA has also established 
exemptions from tolerance for polymeric materials used as pesticide 
inert ingredients that it considers to be intrinsically safe based on 
the fact that they are listed on the TSCA Inventory or meet the 
requirements of the amended TSCA polymer exemption and are thereby not 
subject to the requirements of the pre-manufacturing notification.
    Given the existing widespread and historic use of polybutylene, any 
additional exposure resulting from the approval of polybutylene as an 
inert ingredient in pesticide formulations for use on growing crops or 
to RACs after harvest is not warranted.

C. Cumulative Effects

    At this time there is no information to indicate that any toxic 
effects produced by polybutylene having a number average molecular 
weight of 1,330 would be cumulative with those of any other chemical 
substance(s). Given the categorization of polybutylene as a ``low risk 
polymer''(40 CFR 723.250) and its proposed use as an inert ingredient 
in pesticide formulations, there is no reasonable expectation of 
increased risk due to cumulative exposure.

D. Safety Determination

    1. U.S. population. As a matter of policy, EPA has in the past 
established exemptions from tolerance for polymeric substances used as 
pesticide inert ingredients that it considers to be intrinsically safe 
based on the fact that they are listed on the TSCA Inventory or meet 
the requirements of the amended TSCA polymer exemption and are thereby 
not subject to the requirements of premanufacture notice (PMN). The 
Agency has maintained that polymers meeting the polymer exemption 
criteria will present minimal risk to human health when used as inert 
ingredients in pesticide formulations applied to RACs.
    2. Infants and children. FFDCA section 408 provides that EPA shall 
supply an additional 10-fold margin of safety for infants and children 
in the case of threshold effects where prenatal and/or 
postnataltoxicity are found or there is incompleteness of the data 
base, unless EPA concludes that a different margin of safety will be 
safe for infants and children. Margins of safety are incorporated into 
EPA risk assessments

[[Page 79842]]

either directly through the use of margin of exposure (MOE) analysis or 
through using uncertainty (safety) factors in calculating a dose level 
that poses no appreciable risk to humans. Due to the low expected 
toxicity of polybutylene, a safety factor analysis is not required for 
assessing the risk. For the same reasons the additional safety factor 
is unnecessary.

F. International Tolerances

    Miller Chemical and Fertilizer Corporation is not aware of any 
country requiring a tolerance for polybutylene having a number average 
molecular weight of 1,330. Nor have there been any CODEX maximum 
residue levels (MRLs) established for any food crops at this time.
[FR Doc. 00-32153 Filed 12-19-00; 8:45 a.m.]
BILLING CODE 6560-50-S