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

Note: EPA no longer updates this information, but it may be useful as a reference or resource.
 [Federal Register: August 25, 1999 (Volume 64, Number 164)]
[Notices]               
[Page 46378-46382]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25au99-81]                         

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ENVIRONMENTAL PROTECTION AGENCY

[PF-887; FRL-6096-1]

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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

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

DATES: Comments, identified by docket control number PF-887, must be 
received on or before September 24, 1999.
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'' section. To 
ensure proper receipt by EPA, it is imperative that you identify docket 
control number PF-887 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  By mail: Bipin Gandhi, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460; telephone 
number: (703) 308-8380; and e-mail address: gandhi.bipin@epa.gov.

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            potentially
                                                       affected entities
------------------------------------------------------------------------
Industry                          111                 Crop production

                                  112                 Animal production

                                  311                 Food manufacturing

[[Page 46379]]


                                  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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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'' 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-887. 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-887 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, 401 M St., SW., 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: ``opp-docket@epa.gov,'' 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 5.1/
6.1 or ASCII file format. All comments in electronic form must be 
identified by docket control number PF-887. 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 in the ``FOR FURTHER INFORMATION 
CONTACT'' section.

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 pesticide petitions as follows proposing the 
establishment and/or amendment of regulations for residues of certain 
pesticide chemicals in or on various food commodities under section 408 
of the Federal Food, Drug, and Cosmestic Act (FFDCA), 21 U.S.C. 346a. 
EPA has determined that these petitions contain 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 supports granting of the petitions. Additional data 
may be needed before EPA rules on the petitions.

List of Subjects

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

    Dated: August 17, 1999.

James Jones,

Director, Registration Division, Office of Pesticide Programs.

Summaries of Petitions

    Petitioner summaries of the pesticide petitions are printed below 
as required by section 408(d)(3) of the FFDCA. The

[[Page 46380]]

summaries of the petitions were prepared by the petitioners and 
represent the views of the petitioners. EPA is publishing the petition 
summaries verbatim without editing them 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.

1. Cabot Corporation

PP 9E6017

    EPA has received a pesticide petition (PP 9E6017) from Cabot 
Corporation, 75 State Street, Boston, MA 02109 proposing, pursuant to 
section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 
U.S.C. 346a(d), to amend 40 CFR part 180 to establish an exemption from 
the requirement of a tolerance for dimethyl silicone polymer with 
silica (TS-720) when used in accordance with good agricultural 
practices as an inert ingredient in pesticide formulations applied to 
growing crops in or on the raw agricultural commodity after harvest or 
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 supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    No residue chemistry data are presented in the petition as the 
Agency does not generally require these data to rule on the exemption 
from the requirement of a tolerance for an inert ingredient.

B. Toxicological Profile

    The Agency has established a set of criteria which identifies 
categories of polymers that present low risk. These criteria (described 
in 40 CFR 723.250) identify polymers that are relatively unreactive and 
stable compounds 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. The 
Agency believes that polymers meeting the criteria noted above will 
present minimal or no risk. Cabot Corporation believes that TS-720 
conforms to the definition of a polymer given in 40 CFR 723.250(b) and 
meets the following criteria used to identify a low risk polymer.
    1. TS-720 is not a cationic polymer, nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. TS-720 contains as an integral part of its composition the 
atomic elements carbon, silicon, hydrogen and oxygen.
    3. TS-720 does not contain as an integral part of its composition, 
except as impurities, any element other than those listed in 40 CFR 
723.250(d)(2)(ii).
    4. TS-720 is not designed, nor is it reasonably anticipated to 
substantially degrade, decompose or depolymerize prior to, during, or 
after use.
    5. TS-720 is not manufactured or imported from monomers and/or 
reactants that are not included on the Toxic Substances Control Act 
(TSCA) substance inventory or manufactured under an applicable TSCA 
section 5 exemption.
    6. TS-720 is not a water absorbing polymer with a number average 
molecular weight greater than or equal to 10,000.
    7. TS-720 has an minimum-average molecular weight of 1,100,000 
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 
gastrointestinal (GI) tract. Chemicals not absorbed through the skin or 
GI tract generally are incapable of eliciting a toxic response.
    8. TS-720 has a minimum-average molecular weight of 1,100,000 
daltons. TS-720 meets the requirements for molecular weight 
distribution of oligomer contents of less than 5% with molecular 
weights less than 1,000 and less than 2% with molecular weights less 
than 500. Attached is a description of the molecular weight 
determination of TS-720.
    Cabot Corporation believes that sufficient information has been 
submitted to assess the hazards of TS-720. No toxicology data are being 
submitted as the Agency does not generally require these data to rule 
on the exemption from the requirement of a tolerance for an inert 
ingredient. Because TS-720 conforms with the definition of a polymer 
and meets the criteria of a polymer under 40 CFR 723.250, Cabot 
Corporation believes there are no concerns for risks associated with 
toxicity.

C. Aggregate Exposure

    1.  Dietary exposure. TS-720 is not absorbed through the intact 
gastrointestinal tract and is incapable of eliciting a toxic response.
    2. Drinking water. TS-720 is not soluble in water and therefore 
there is no reason to expect human exposure to residues in water.
    3. Non-dietary exposure. For most uses of TS-720 the primary route 
of exposure is dermal. TS-720, with a molecular weight significantly 
greater than 400, is not absorbed through the intact skin.

D. Cumulative Effects

    Cabot Corporation believes that sufficient information has been 
submitted to assess the hazards of TS-720. Because TS-720 conforms with 
the definition of a polymer and meets the criteria of a polymer under 
40 CFR 723.250, Cabot Corporation believes there are no concerns for 
risks associated with cumulative effects.

E. Safety Determination

    1. U.S. population. Cabot Corporation believes that sufficient 
information has been submitted to assess the hazards of TS-720. Because 
TS-720 conforms with the definition of a polymer and meets the criteria 
of a polymer under 40 CFR 723.250, Cabot Corporation believes there are 
no concerns for risks associated with any potential exposure to adults.
    2. Infants and children. Cabot Corporation believes that sufficient 
information has been submitted to assess the hazards of TS-720. Because 
TS-720 conforms with the definition of a polymer and meets the criteria 
of a polymer under 40 CFR 723.250, Cabot Corporation believes there are 
no concerns for risks associated with exposure to infants and children.

2. Cabot Corporation

PP 9E6018

    EPA has received a pesticide petition (PP 9E6018) from Cabot 
Corporation, proposing, pursuant to section 408(d) of 21 U.S.C. 
346a(d), to amend 40 CFR part 180 to establish an exemption from the 
requirement of a tolerance for silane, dichloromethyl-, reaction 
product with silica (TS-610) when used in accordance with good 
agricultural practices as an inert ingredient in pesticide formulations 
applied to growing crops in or on the raw agricultural commodity after 
harvest or 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 
supports granting of the petition. Additional data may be needed before 
EPA rules on the petition.

[[Page 46381]]

A. Residue Chemistry

    No residue chemistry data are presented in the petition as the 
Agency does not generally require these data to rule on the exemption 
from the requirement of a tolerance for an inert ingredient.

B. Toxicological Profile

    The Agency has established a set of criteria which identifies 
categories of polymers that present low risk. These criteria (described 
in 40 CFR 723.250) identify polymers that are relatively unreactive and 
stable compounds 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. The 
Agency believes that polymers meeting the criteria noted above will 
present minimal or no risk. Cabot Corporation believes that TS-610 
conforms to the definition of a polymer given in 40 CFR 723.250(b) and 
meets the following criteria used to identify a low risk polymer.
    1. TS-610 is not a cationic polymer, nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. TS-610 contains as an integral part of its composition the 
atomic elements carbon, silicon, hydrogen and oxygen.
    3. TS-610 does not contain as an integral part of its composition, 
except as impurities, any element other than those listed in 40 CFR 
723.250(d)(2)(ii).
    4. TS-610 is not designed, nor is it reasonably anticipated to 
substantially degrade, decompose or depolymerize prior to, during, or 
after use.
    5. TS-610 is not manufactured or imported from monomers and/or 
reactants that are not included on the TSCA substance inventory or 
manufactured under an applicable TSCA section 5 exemption.
    6. TS-610 is not a water absorbing polymer with a number average 
molecular weight greater than or equal to 10,000.
    7. TS-610 has an minimum-average molecular weight of 3,340,000 
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 
gastrointestinal (GI) tract. Chemicals not absorbed through the skin or 
GI tract generally are incapable of eliciting a toxic response.
    8. TS-610 has a minimum-average molecular weight of 3,340,000 
daltons. TS-610 meets the requirements for molecular weight 
distribution of oligomer contents of less than 5% with molecular 
weights less than 1,000 and less than 2% with molecular weights less 
than 500.
    Cabot Corporation believes that sufficient information has been 
submitted to assess the hazards of TS-610. No toxicology data are being 
submitted as the Agency does not generally require these data to rule 
on the exemption from the requirement of a tolerance for an inert 
ingredient. Because TS-610 conforms with the definition of a polymer 
and meets the criteria of a polymer under 40 CFR 723.250, Cabot 
Corporation believes there are no concerns for risks associated with 
toxicity.

C. Aggregate Exposure

    1. Dietary exposure. TS-610 is not absorbed through the intact GI 
tract and is incapable of eliciting a toxic response.
    2. Drinking water. TS-610 is not soluble in water and therefore 
there is no reason to expect human exposure to residues in water.
    3. Non-dietary exposure. For most uses of TS-610 the primary route 
of exposure is dermal. TS-610, with a molecular weight significantly 
greater than 400, is not absorbed through the intact skin.

D. Cumulative Effects

    Cabot Corporation believes that sufficient information has been 
submitted to assess the hazards of TS-610. Because TS-610 conforms with 
the definition of a polymer and meets the criteria of a polymer under 
40 CFR 723.250, Cabot Corporation believes there are no concerns for 
risks associated with cumulative effects.

E. Safety Determination

    1. U.S. population. Cabot Corporation believes that sufficient 
information has been submitted to assess the hazards of TS-610. Because 
TS-610 conforms with the definition of a polymer and meets the criteria 
of a polymer under 40 CFR 723.250, Cabot Corporation believes there are 
no concerns for risks associated with any potential exposure to adults.
    2. Infants and children. Cabot Corporation believes that sufficient 
information has been submitted to assess the hazards of TS-610. Because 
TS-610 conforms with the definition of a polymer and meets the criteria 
of a polymer under 40 CFR 723.250, Cabot Corporation believes there are 
no concerns for risks associated with exposure to infants and children.

3. Cabot Corporation

PP 9E6019

    EPA has received a pesticide petition PP 9E6019 from Cabot 
Corporation, proposing, pursuant to section 408(d) of 21 U.S.C. 
346a(d), to amend 40 CFR part 180 to establish an exemption from the 
requirement of a tolerance for hexamethyldisilizane, reaction product 
with silica (TS-530) when used in accordance with good agricultural 
practices as an inert ingredient in pesticide formulations applied to 
growing crops in or on the raw agricultural commodity after harvest or 
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 supports granting of 
the petition. Additional data may be needed before EPA rules on the 
petition.

A. Residue Chemistry

    No residue chemistry data are presented in the petition as the 
Agency does not generally require these data to rule on the exemption 
from the requirement of a tolerance for an inert ingredient.

B. Toxicological Profile

    The Agency has established a set of criteria which identifies 
categories of polymers that present low risk. These criteria (described 
in 40 CFR 723.250) identify polymers that are relatively unreactive and 
stable compounds 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. The 
Agency believes that polymers meeting the criteria noted above will 
present minimal or no risk. Cabot Corporation believes that TS-530 
conforms to the definition of a polymer given in 40 CFR 723.250(b) and 
meets the following criteria used to identify a low risk polymer.
    1. TS-530 is not a cationic polymer, nor is it reasonably 
anticipated to become a cationic polymer in a natural aquatic 
environment.
    2. TS-530 contains as an integral part of its composition the 
atomic elements carbon, silicon, hydrogen and oxygen.
    3. TS-530 does not contain as an integral part of its composition, 
except as impurities, any element other than those listed in 40 CFR 
723.250(d)(2)(iii).
    4. TS-530 is not designed, nor is it reasonably anticipated to 
substantially

[[Page 46382]]

degrade, decompose or depolymerize prior to, during, or after use.
    5. TS-530 is not manufactured or imported from monomers and/or 
reactants that are not included on the TSCA substance inventory or 
manufactured under an applicable TSCA section 5 exemption.
    6. TS-530 is not a water absorbing polymer with a number average 
molecular weight greater than or equal to 10,000.
    7. TS-530 has an minimum-average molecular weight of 645,000 
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 GI 
tract. Chemicals not absorbed through the skin or GI tract generally 
are incapable of eliciting a toxic response.
    8. TS-530 has a minimum-average molecular weight of 645,000 
daltons. TS-530 meets the requirements for molecular weight 
distribution of oligomer contents of less than 5% with molecular 
weights less than 1,000 and less than 2% with molecular weights less 
than 500. Attached is a description of the molecular weight 
determination of TS-530.
    Cabot Corporation believes that sufficient information has been 
submitted to assess the hazards of TS-530. No toxicology data are being 
submitted as the Agency does not generally require these data to rule 
on the exemption from the requirement of a tolerance for an inert 
ingredient. Because TS-530 conforms with the definition of a polymer 
and meets the criteria of a polymer under 40 CFR 723.250, Cabot 
Corporation believes there are no concerns for risks associated with 
toxicity.

C. Aggregate Exposure

    1.  Dietary exposure. TS-530 is not absorbed through the intact GI 
tract and is incapable of eliciting a toxic response.
    2. Drinking water. TS-530 is not soluble in water and therefore 
there is no reason to expect human exposure to residues in water.
    3. Non-dietary exposure. For most uses of TS-530 the primary route 
of exposure is dermal. TS-530 with a molecular weight significantly 
greater than 400 is not absorbed through the intact skin.

D. Cumulative Effects

    Cabot Corporation believes that sufficient information has been 
submitted to assess the hazards of TS-530. Because TS-530 conforms with 
the definition of a polymer and meets the criteria of a polymer under 
40 CFR 723.250, Cabot Corporation believes there are no concerns for 
risks associated with cumulative effects.

E. Safety Determination

    1. U.S. population. Cabot Corporation believes that sufficient 
information has been submitted to assess the hazards of TS-530. Because 
TS-530 conforms with the definition of a polymer and meets the criteria 
of a polymer under 40 CFR 723.250, Cabot Corporation believes there are 
no concerns for risks associated with any potential exposure to adults.
    2. Infants and children. Cabot Corporation believes that sufficient 
information has been submitted to assess the hazards of TS-530. Because 
TS-530 conforms with the definition of a polymer and meets the criteria 
of a polymer under 40 CFR 723.250, Cabot Corporation believes there are 
no concerns for risks associated with exposure to infants and children.

[FR Doc. 99-22049 Filed 8-24-99; 8:45 am]
BILLING CODE 6560-50-F
Notice of Filing a Pesticide Petition to Establish a Tolerance for Certain Pesticide Chemicals in or on Food

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