[Federal Register: March 5, 2003 (Volume 68, Number 43)]
[Notices]
[Page 10474-10477]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr03-59]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-2003-0051; FRL-7294-3]
Ammonium Thiosulfate; 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 ID number OPP-2003-0051, must be
received on or before April 4, 2003.
ADDRESSES: Comments may be submitted electronically, by mail, or
through hand delivery/courier. Follow the detailed instructions as
provided in Unit I. of the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Jim Tompkins, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 305-5697; e-mail address: tompkins.jim]@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
[sbull] Industry (NAICS 111)
[sbull] Crop production (NAICS 112)
[sbull] Animal production (NAICS 311)
[sbull] Food manufacturing, and Pesticide manufacturing (NAICS
32532)
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 this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
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 Copies of this Document and Other Related Information?
1. Docket. EPA has established an official public docket for this
action under docket (ID) number OPP-2003-0051. The official public
docket consists of the documents specifically referenced in this
action, any public comments received, and other information related to
this action. Although, a part of the official docket, the public docket
does not include Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. The official
public docket is the collection of materials that is available for
public viewing at the Public Information and Records Integrity Branch
(PIRIB), Rm. 119, Crystal Mall 2, 1921 Jefferson Davis Hwy.,
Arlington, VA. This docket facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The docket telephone
number is (703) 305-5805.
2. Electronic access. You may access this Federal Register document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr/.
An electronic version of the public docket is available through
EPA's electronic public docket and comment system, EPA Dockets. You may
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
use EPA Dockets at http://www.epa.gov/edocket/ to submit or view public
comments, access the index listing of the contents of the official
public docket, and to access those documents in the public docket that
are available electronically. Although, not all docket materials may be
available electronically, you may still access any of the publicly
available docket materials through the docket facility identified in
Unit I.B.1. Once in the system, select ``search,'' then key in the
appropriate docket ID number.
Certain types of information will not be placed in the EPA
dockets. Information claimed as CBI and other information whose
disclosure is restricted by statute, which is not included in the
official public docket, will not be available for public viewing in
EPA's electronic public docket. EPA's policy is that copyrighted
material will not be placed in EPA's electronic public docket but will
be available only in printed, paper form in the official public docket.
To the extent feasible, publicly available docket materials will be
made available in EPA's electronic public docket. When a document is
selected from the index list in EPA dockets, the system will identify
whether the document is available for viewing in EPA's electronic
public docket. Although, not all docket materials may be available
electronically, you may still access any of the publicly available
docket materials through the docket facility identified in Unit I.B.
EPA intends to work towards providing electronic access to all of the
publicly available docket materials through EPA's electronic public
docket.
For public commenters, it is important to note that EPA's policy
is that public comments, whether submitted electronically or on paper,
will be made available for public viewing in EPA's electronic public
docket as EPA receives them and without change, unless the comment
contains copyrighted material, CBI, or other information whose
disclosure is restricted by statute. When EPA identifies a comment
containing copyrighted material, EPA will provide a reference to that
material in the version of the comment that is placed in EPA's
electronic public docket. The entire printed comment, including the
copyrighted material, will be available in the public docket.
Public comments submitted on computer disks that are mailed or
delivered to the docket will be transferred to EPA's electronic public
docket. Public comments that are mailed or delivered to the docket will
be scanned and placed in EPA's electronic public docket. Where
practical, physical objects will be photographed, and the photograph
will be placed in EPA's electronic public docket along with a brief
description written by the docket staff.
C. How and To Whom Do I Submit Comments?
You may submit comments electronically, by mail, or through hand
delivery/courier. To ensure proper receipt by EPA, identify the
appropriate docket ID number in the subject line on the first page of
your comment. Please ensure that your comments are submitted within the
specified comment period. Comments received after the close of the
comment period will be marked ``late.'' EPA is not required to consider
these late comments. If you wish to submit CBI or information that is
otherwise protected by statute, please follow the instructions in Unit
I.D. Do not use EPA dockets or e-mail to submit CBI or information
protected by statute.
1. Electronically. If you submit an electronic comment as
prescribed in this unit, EPA recommends that you include your name,
mailing address, and an e-mail address or other contact information in
the body of your comment. Also, include this contact information on the
outside of any disk
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or CD ROM you submit, and in any cover letter accompanying the disk or
CD ROM. This ensures that you can be identified as the submitter of the
comment and allows EPA to contact you in case EPA cannot read your
comment due to technical difficulties or needs further information on
the substance of your comment. EPA's policy is that EPA will not edit
your comment, and any identifying or contact information provided in
the body of a comment will be included as part of the comment that is
placed in the official public docket, and made available in EPA's
electronic public docket. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment.
i. EPA Dockets. Your use of EPA's electronic public docket to
submit comments to EPA electronically is EPA's preferred method for
receiving comments. Go directly to EPA dockets at http://www.epa.gov/
edocket
, and follow the online instructions for submitting comments.
Once in the system, select ``search'' and then key in docket ID number
OPP-2003-0051. The system is an ``anonymous access'' system, which
means EPA will not know your identity, e-mail address, or other contact
information unless you provide it in the body of your comment.
ii. E-mail. Comments may be sent by e-mail to opp-docket@epa.gov,
Attention: Docket ID number OPP-2003-0051. In contrast to EPA's
electronic public docket, EPA's e-mail system is not an ``anonymous
access'' system. If you send an e-mail comment directly to the docket
without going through EPA's electronic public docket, EPA's e-mail
system automatically captures your e-mail address. E-mail addresses
that are automatically captured by EPA's e-mail system are included as
part of the comment that is placed in the official public docket, and
made available in EPA's electronic public docket.
iii. Disk or CD ROM. You may submit comments on a disk or CD ROM
that you mail to the mailing address identified in Unit I.C.2. These
electronic submissions will be accepted in WordPerfect or ASCII file
format. Avoid the use of special characters and any form of encryption.
2. By mail. Send your comments to: Public Information and Records
Integrity Branch (PIRIB) (7502C), Office of Pesticide Programs (OPP),
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001, Attention: Docket ID number OPP-2003-0051.
3. By hand delivery or courier. Deliver your comments to: Public
Information and Records Integrity Branch (PIRIB), Office of Pesticide
Programs (OPP), Environmental Protection Agency, Rm. 119, Crystal Mall
2, 1921 Jefferson Davis Hwy., Arlington, VA, Attention: Docket
ID number OPP-2003-0051. Such deliveries are only accepted during the
docket's normal hours of operation as identified in Unit I.B.1.
D. How Should I Submit CBI to the Agency?
Do not submit information that you consider to be CBI
electronically through EPA's electronic public docket or by e-mail. You
may claim information that you submit to EPA as CBI by marking any part
or all of that information as CBI (if you submit CBI on disk or CD ROM,
mark the outside of the disk or CD ROM as CBI and then identify
electronically within the disk or CD ROM the specific information that
is 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 docket and EPA's electronic public docket. If you submit
the copy that does not contain CBI on disk or CD ROM, mark the outside
of the disk or CD ROM clearly that it does not contain CBI. Information
not marked as CBI will be included in the public docket and EPA's
electronic public docket without prior notice. If you have any
questions about CBI or the procedures for claiming CBI, please consult
the person listed 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
ID 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 Cosmetic Act (FFDCA), 21 U.S.C. 346a.
EPA has determined that this petition contains data or information
regarding the elements set forth in FFDCA 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: February 20, 2003.
Debra Edwards,
Acting Director, Registration Division, Office of Pesticide Programs.
Summary of Petition
The petitioner's summary of the pesticide petition is printed below
as required by FFDCA section 408(d)(3). The summary of the petition was
prepared by Siemer and Associates Inc., and represents the view of the
petitioner. 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.
Siemer and Associates, Inc.
PP 6F4789
EPA has received a pesticide petition (PP 6F4789) from Siemer and
Associates, Inc. on behalf of National Chelating, 4672 West Jennifer,
Suite 103, Fresno, CA 93722, proposing pursuant to section 408(d) of
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. 346a(d), to amend 40
CFR part 180 by establishing an exemption from the requirements for a
tolerance for ammonium thiosulfate when used for blossom thinning on
apples.
Pursuant to the section 408(d)(2)(A)(i) of the FFDCA, as amended,
Siemer and Associates, Inc., on behalf of National Chelating has
submitted the following
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summary of information, data and arguments in support of their
pesticide petition. This summary was prepared by Siemer and Associates,
Inc., and EPA has not fully evaluated the merits of the petition. EPA
edited the summary to clarify that the conclusions and arguments were
the petitioner's and not necessarily EPA's and to remove certain
extraneous material.
On August 30, 1996 Siemer and Associates on behalf of National
Chelating petitioned EPA, under pesticide petition 6F4789, for a
permanent exemption from the requirements of a tolerance for ammonium
thiosulfate on apples.
Section 408(b)(2)(A) of the amended Federal Food, Drug, and
Cosmetic Act allows the EPA to establish an exemption from the
requirements for a tolerance only if the Administrator determines that
there is a ``reasonable certainty that no harm will result from the
aggregate exposure to the pesticide chemical residue, including all
anticipated dietary exposures and all other exposures for which there
is reliable information.''
The available information indicates that there is a reasonable
certainty that no harm will result from various types of exposure.
Requests for waivers from the requirements of performing studies for
known chemistry are presented and substantiated. The following is a
summary of the information submitted to EPA, to support the
establishment, under Section 408(b)(2)(D) of the amended FFDCA, of a
tolerance for ammonium thiosulfate on apples.
A. Residue Chemistry
1. Plant metabolism. The qualitative nature of the residues of
ammonium thiosulfate in apple is adequately understood. The requirement
for residue studies was waived by EPA based on the knowledge that
ammonium thiosulfate has been used as a soil applied and foliar applied
fertilizer for many years. Prior experience and numerous publications
teach that ammonium thiosulfate ionizes when placed into water, forming
an ammonium ion and a thiosulfate ion which further degrades to form
elemental sulfur and a sulfate ion. The sulfur is further oxidized to
form a sulfate ion. The ammonium and sulfate ions thus formed are
absorbed into the growing plant and moved into the naturally occurring
nitrogen and sulfate pools that occur naturally in growing plants. Once
applied to the plant, without isotope identification, it is not
possible to separate the ammonium and sulfate ions that will occur from
those that already occur naturally in the plant. On this basis, an
exemption from the requirements of a tolerance is justified. There is
no analytical method needed since there is no practical way to separate
the ammonium and sulfate ions from those that naturally occur.
2. Analytical method. The need for an analytical method is waived
on the basis that there is no need for analyzing for the component of
ammonium and sulfate ion applied for blossom thinning purposes.
3. Magnitude of residues. No residues of ammonium thiosulfate will
be identified separately from those ammonium and sulfate ions naturally
occurring. This result supports the proposed exemption from the
requirements for a tolerance.
B. Toxicological Profile
A request to waive the battery of mammalian toxicity studies for
ammonium thiosulfate is based on and justified by the following:
1. Acute toxicity. Based on EPA criteria, ammonium thiosulfate
previously registered for a non-food use as an ornamental herbicide has
been shown to be relatively non-toxic and has been registered for non-
food use purposes as a Category III herbicide. These data have
previously been supplied to the agency.
2. Genotoxicity. A request for a waiver from the following
requirements is made on the basis that sodium thiosulfate is on the
Food and Drug Administration's Generally Recognized as Safe (GRAS) list
at 21 CFR 184.1807, and ammonium thiosulfate is already exempted from
the requirements of a tolerance when used in accordance with good
agricultural practices as inert (or occasionally active) ingredients in
pesticide formulations applied to growing crops or to raw agricultural
commodities after harvest (at 40 CFR 180.1001(c)). Ammonium thiosulfate
ionizes to form ammonium ion and thiosulfate ion in water with neither
of these ions being mutagenic or genotoxic. On that basis the following
tests are requested to be waived.
i. Gene Mutation - Ames.
ii. In vitro Structural chromosomal aberration assay.
iii. In vitro CHO/HGPRT assay.
iv. In vivo micronucleus aberration assay.
3. Reproductive and developmental toxicity. A request for waiving
the data requirements for the following is made on the basis of the
discussion in paragraph B. above. In addition, all of the tests listed
below rely on feeding the test substance, to animals that have acidic
stomachs. Placing ammonium thiosulfate into an acidic environment will
cause near instantaneous ion formation giving rise to ammonium and
thiosulfate ions, which ultimately breaks down to elemental sulfur and
sulfite. These sulfur forms will be quickly oxidized under acidic
conditions to sulfate, which will be incorporated into the normal
sulfate pool that exists within the metabolic system of the various
animal test systems. The ammonium ion will react with the acidic
component, most likely forming ammonium chloride which will be
metabolized in a well understood pathway in the systems of the various
animal test systems. The new moiety formed in this acidic medium is the
sulfite ion which also is well understood and is quickly oxidized to
sulfate. The FDA instituted studies in 1975 and 1985 on the GRAS status
of sulfite and, as a result of these studies, has substantiated the
GRAS status except for a few individuals that might be allergic to
sulfite. In this proposed usage, however, the sulfite will not reach
the possibly allergic people, since the sulfite will be metabolized to
sulfate in the plant system before reaching any sensitive people who
may consume the treated tissue. The data waivers requested are as
follows:
i. Teratology in rats.
ii. Teratology in rabbits.
iii. 2-Generation reproduction in rats.
4. Subchronic toxicity. The data requirements listed below are
requested to be waived on the basis illustrated above at paragraph B.
3.
i. 28-Day dermal in rats.
ii. 13-Week oral feeding in rats.
iii. 90-Day oral feeding in dogs.
5. Chronic toxicity. The data requirements listed below are
requested to be waived for reasons listed above at paragraph B. 3.
i. 1-Year chronic toxicity in dogs.
ii. 18-month chronic toxicity and carcinogenicity in mice.
iii. 24-month chronic toxicity and carcinogenicity in rats.
6. Animal metabolism. The metabolism of ammonium thiosulfate is
well understood in animals. As listed above, this substance rapidly
ionizes in the acidic portion of the animal gut, giving rise to
ammonium ion and sulfate ion. Both of these substances are required and
occur in the metabolism of animals.
7. Metabolite toxicology. No toxicologically significant
metabolites will be detected in plant or animal metabolism studies
using ammonium thiosulfate. Therefore, no metabolites are required to
be regulated.
8. Endocrine effects. There is no information available that
suggest that
[[Page 10477]]
ammonium thiosulfate would be associated with endocrine effects.
C. Aggregate Exposure
1. Dietary exposure--i Food. There will be no residues of ammonium
thiosulfate that will reach any portion of the U.S. population as a
result of using ammonium thiosulfate as a blossom thinner on apples.
The ammonium and sulfate ions that will arise will not be different
from the naturally occurring forms of the ions, which exceed by far the
amount that will be applied as a result of the use of the ammonium
thiosulfate.
ii. Drinking water. Ammonium and sulfate ions that arise from
ammonium thiosulfate use will add no additional burden to the drinking
water. The end points of the two ions formed as a result of ammonium
thiosulfate use will both be used in plant nutrition. The ammonium form
of nitrogen resists leaching by binding to the colloid fraction in the
soil to resist ground water contamination. The amount of sulfate added
as a result of the described use will add an imperceptible amount to
the sulfate level already in existence in the soil.
There is a reasonable certainty that no harm will result from
dietary exposure to ammonium thiosulfate, because dietary exposures to
residues on food cannot be differentiated from those that will occur
naturally in food, and exposure through drinking water is expected to
be insignificant.
2. Non-dietary exposure. There is no non-dietary exposure expected,
since any ammonium thiosulfate finding its way onto the plants or
around any plants will be absorbed and metabolized into naturally
occurring plant constituents.
D. Cumulative Effects
There are no cumulative effects expected since the ammonium
thiosulfate metabolites are all incorporated into naturally occurring
constituents found in all plant systems.
E. Safety Determination
1. U.S. population. The natural occurrence of the metabolites of
the ammonium and sulfate ions in all plants and in humans is the basis
for the Generally Recognized As Safe characterization of the
thiosulfate ion and the use of the ammonium ion as a component in
nearly all fertilizers, supports the conclusion that there is a
``reasonable certainty of no harm'' from aggregate exposure to ammonium
thiosulfate.
2. Infants and children. No developmental, reproductive or
fetotoxic effects have been associated with ammonium thiosulfate and
its use as a fertilizer. The calculation of safety margins with respect
to ammonium thiosulfate is unnecessary since the ammonium and sulfate
ions that will arise from the use of ammonium thiosulfate will add only
slightly to the already naturally occurring nitrogen and sulfur pools
in existence in various plants. Since there will be no residues of
toxicological significance resulting from ammonium thiosulfate,
calculations of safety margins are not necessary based on the lack of
any unnatural residues.
F. International Tolerances
There is no codex maximum residue level established for ammonium
thiosulfate on apple. However, ammonium thiosulfate is widely used as a
nutrient in many parts of the world.
[FR Doc. 03-5036 Filed 3-4-03; 8:45 am]
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