[Federal Register Volume 64, Number 164 (Wednesday, August 25, 1999)]
[Notices]
[Pages 46378-46382]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22049]
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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.
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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]
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