Ferric Sodium EDTA; Notice of Filing a Pesticide Petition to Establish a Tolerance for a Certain Pesticide Chemical in or on Food, 33474-33478 [05-11165]
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Federal Register / Vol. 70, No. 109 / Wednesday, June 8, 2005 / Notices
Innovation (OEPI) which has been given
responsibility for implementation of this
program. Since its inception in 1995,
over 100 Project XL proposals have been
received and reviewed, and over 50
pilot projects have been implemented.
Of these approximately nine (9) have
been completed, thirteen (13) have been
terminated prior to completion and
thirty (30) remain to be completed. The
program itself includes other offices
within EPA headquarters, EPA regions,
federal, state, tribal and local
government agencies. The renewal of
this ICR is important as it will allow the
Agency to continue to work with
sponsors of these innovation pilots, and
to respond to additional regulated
entities who are interested in innovation
pilot projects.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations are listed
in 40 CFR Part 9 and 48 CFR Chapter
15.
The EPA would like to solicit
comments to:
(i) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(ii) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(iii) Enhance the quality, utility, and
clarity of information to be collected:
and
(iv) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated electronic,
mechanical, or other technological
collection techniques or other forms of
information technology; e.g., permitting
electronic submissions of responses.
Burden Statement: This section
presents EPA’s estimates of the burden
and cost to complete the information
collection activities associated with this
collection. In using this analysis,
however, it should be remembered not
only that all responses to this
solicitation are voluntary, but also that
respondents have some expected value
attached with their participation.
Fundamental to projects in this program
will be reduced cost of compliance due
to increased regulatory flexibility. Not
unlike a contracts-based Request For
Proposals, one would not expect a
response from any entity where the
burdens associated with preparing the
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response outweigh the expected benefits
to the respondent.
Information requests are expected for
approximately 40 XL projects over the
lifetime of this ICR as well as
approximately 30 other projects that
have been developed under the State
Innovation Grants and other
mechanisms. The State Grants Program
uses a competition process established
under 40 CFR 31 and compliant with
the requirements established in the
Agency’s Assistance Agreement
Competition Policy (EPA E.O.
5700.5A1). Under that policy, States
compete for funds by responding to an
annual solicitation with a brief initial
proposal. States that are selected based
upon an evaluation using published
criteria are asked to submit a more
detailed proposal leading to award. The
average number of annual awards is
eight (8).
Information will also be requested for
implemented projects as part of periodic
reporting required for grants
management and for projects that are
approaching completion, or have
reached completion and for which
information is requested to document
the outcome of each project. In the ten
years since the March 16, 1995
announcement of the program, EPA
received over 100 Project XL proposals.
In the tenth year of the program, EPA
continues to receive inquiries about the
program.
During the lifetime of this ICR, EPA
will solicit information from project
sponsors regarding the process and
outcomes for projects at completion.
This addresses the commitment of each
project sponsor established in the
project FPA to report on the final
outcomes of the project and to provide
relevant information to allow EPA to
assess the degree of success for each of
these projects and examine the
impediments to implementation that are
relevant to potential future attempts to
scale up successful innovations
demonstrated in Project XL or other
families of innovation to broader scale
application. To complete a project final
report and respond to a follow-up
questionnaire, EPA estimates that each
project sponsor will use forty (40) hours
of time, and further estimates the thirty
(40) XL projects at or approaching
completion will require a total of 1600
hours (40 hours x 40 projects). Further,
EPA estimates that its own analysts will
require an additional twenty (20) hours
of time per project to read and extract
information on project measures and
outcomes, or a total of 600 hours. EPA
estimates that eighteen hundred (2200)
hours of time may reflect a cost of
$660,000. Similarly, EPA anticipates
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that State Innovation Grants Projects
may require States to expend up to 40
hours in preparation for each preproposal for a total of 1000 hours as an
annual average (40x25). The small
number of States selected and asked to
provide a more detailed proposal may
expend up to 100 hours per proposal for
a total of 800 hours (8x100) annually
(1800 hours annually). Over the period
of this ICR, States may expend up to
5400 hours (1800x3) preparing
proposals for State Innovation Grants;
EPA anticipates expending up to 2000
hours for analysis of this information. In
addition, quarterly reporting on
projects, now required under assistance
agreement policy may account for 64
hours of time annually for recipient
States and 100 hours annually for EPA
to complete analysis. The anticipated
total cost of this reporting is estimated
at $2,400,000.
No capital or start-up costs will be
associated with this effort.
Burden means total time, effort, or
financial resources expended by persons
to generate, maintain, retain, or disclose
or provide information to or for a
Federal agency. This includes the time
needed to review instructions; develop,
acquire, install, and utilize technology
and systems for the purposes of
collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; adjust the
existing ways to comply with any
previously applicable instructions and
requirements; train personnel to be able
to respond to a collection of
information; search data sources;
complete and review the collection of
information; and transmit or otherwise
disclose the information.
Dated: May 23, 2005.
Gregory Ondich,
Acting Office Director, Office of
Environmental Policy Innovation.
[FR Doc. 05–11383 Filed 6–7–05; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
[OPP–2005–0131; FRL–7715–5]
Ferric Sodium EDTA; Notice of Filing a
Pesticide Petition to Establish a
Tolerance for a Certain Pesticide
Chemical in or on Food
Environmental Protection
Agency (EPA).
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
initial filing of a pesticide petition
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proposing the establishment of
regulations for residues of a certain
pesticide chemical in or on various food
commodities.
DATES: Comments, identified by docket
identification (ID) number OPP–2005–
0131, must be received on or before July
8, 2005.
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:
Todd Peterson, Biopesticides and
Pollution Prevention Division (7511C),
Office of Pesticide Programs,
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–7224; e-mail address:
peterson.todd@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by
this action if you an agricultural
producer, food manufacturer, or
pesticide manufacturer. Potentially
affected entities may include, but are
not limited to:
• Crop production (NAICS 111)
• Animal production (NAICS 112)
• Food manufacturing (NAICS 311)
• 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 identification (ID) number
OPP–2005–0131. 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
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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, 1801 S. Bell St.,
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
https://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 https://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.1. 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
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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 email address or other contact
information in the body of your
comment. Also, include this contact
information on the outside of any disk
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,
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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 https://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–2005–0131. 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–
2005–0131. 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–2005–0131.
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, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID
number OPP–2005–0131. Such
deliveries are only accepted during the
docket’s normal hours of operation as
identified in Unit I.B.1.
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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
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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: May 24, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution
Prevention 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 the Woodstream
Corporation 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.
Woodstream Corporation
PP 5F6899
EPA has received a pesticide petition
(PP 5F6899) from Woodstream
Corporation, 69 N. Locust Street, Lititz,
PA 17543–0327, 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 the
biochemical pesticide ferric sodium
EDTA.
Pursuant to section 408(d)(2)(A)(i) of
the FFDCA, as amended, Woodstream
Corporation has submitted the following
summary of information, data, and
arguments in support of their pesticide
petition. This summary was prepared by
Woodstream Corporation and EPA has
not fully evaluated the merits of the
pesticide petition. The summary may
have been edited by EPA if the
terminology used was unclear, the
summary contained extraneous
material, or the summary
unintentionally made the reader
conclude that the findings reflected
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EPA’s position and not the position of
the petitioner.
A. Product Name and Proposed Use
Practices
Ferric sodium EDTA (technical grade
active ingredient) and slug and snail
killer (end-use product). Ferric sodium
EDTA is a highly efficacious
replacement for metaldehyde for the
control of snails and slugs. The
proposed end-use product (slug and
snail killer) contains 6.00% active
ingredient in a flour-based pellet. All
intentionally added inert ingredients are
exempt from the requirement of a
tolerance when used in pesticides and
are on EPA’s List 4. Use sites proposed
include agricultural crops, turf and
ornamentals and home gardens; all areas
where slugs and snails are a problem.
The end-use product is applied directly
to the soil surface. A draft end-use
product label has been submitted with
the corresponding application for FIFRA
section 3 registration.
B. Product Identity/Chemistry
1. Identity of the pesticide and
corresponding residues. The active
ingredient, ferric sodium EDTA, is
comprised of iron in a sodium EDTA
chelate. Ferric sodium EDTA is a
commodity ingredient used in the
photographic industry as a bleaching
agent, used in agriculture as a
micronutrient, and used in the chemical
industry as a catalyst. Ferric sodium
EDTA is also currently being evaluated
as a way of fortifying foods to prevent
anemia and iron deficiencies in
developing countries. Iron is an
essential element for nutrition and is
listed as GRAS for direct addition to
food per 21 CFR 184.1375. Sodium
EDTA is a common chelating agent,
which immobilizes metal ions until in
an environment where they are
available for uptake. Sodium EDTA is
exempt per 40 CFR 180.1001 when used
in pesticide formulations, and is a direct
food additive per 21 CFR 172.135.
Ferric sodium EDTA has been
classified as ‘‘Not a biochemical, but
eligible for a reduced data set’’ per the
Agency’s letter received May 16, 2001.
EPA states the classification is based on
the abundance of iron in nature, its low
toxicity, its use as a nutritional
supplement, and it slow water
solubility.
The end-use product Snail and Slug
Control is formulated in pellet form
with food attractants (flour-based
ingredients). Snails and slugs are
attracted to and ingest the pellets. When
ingested, the iron in ferric sodium
EDTA is available for uptake into the
mollusks gut. Normally iron is
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prevented from passing through the gut
barrier; however, the formulation of iron
with the chelating agent EDTA allows
for iron to pass the gut barrier. Once
passed, the iron partially acidifies the
mollusks copper-based blood resulting
in sickness. The mollusk stops feeding
and leaves the area.
2. Magnitude of residue at the time of
harvest and method used to determine
the residue.
3. A statement of why an analytical
method for detecting and measuring the
levels of the pesticide residue are not
needed. An analytical method for
residues is not applicable. It is expected
that, when used as proposed, ferric
sodium EDTA would not result in
residues that are of toxicological
concern.
C. Mammalian Toxicological Profile
Studies to evaluate the safety to
mammals were conducted on the
technical grade active ingredient (tgai)
and are summarized as follows:
1. Acute oral toxicity (OPPTS
Harmonized Guideline 870.1100): No
adverse effects were seen in rats that
received an oral gavage dose of 5,000
milligrams/kilogram body weight (mg/
kg bwt) of the technical grade active
ingredient. No rats died during the 14–
day observation period, and no gross
pathological changes were found in
organs in the thoracic or abdominal
cavities at necropsy. A LD50 >5,000 mg/
kg was established.
2. Acute dermal toxicity (OPPTS
Harmonized Guideline 870.1200): No
adverse effects were seen in rats that
received a dermal dose of 5,000 mg/kg
bwt of the technical grade active
ingredient. No effects on appearance,
behavior or body weight were observed
in any rats any time after exposure. No
rats died during the 14–day observation
period, and no gross pathological
changes were found in organs in the
thoracic or abdominal cavities at
necropsy. A LD50 >5,000 mg/kg was
established.
3. Acute inhalation toxicity (OPPTS
Harmonized Guideline 870.1300). No
adverse effects were seen in rats that
were exposed by inhalation for 4 hours
to a concentration of 2.05 milligrams/
Liter (mg/L) of the technical grade active
ingredient. No effects on appearance,
behavior or body weight were observed
in any rats any time after exposure. No
rats died during the 14–day observation
period, and no gross pathological
changes were found in organs in the
thoracic or abdominal cavities at
necropsy. A LD50 >2.05 mg/L was
established.
4. Primary eye irritation (OPPTS
Harmonized Guideline 870.2400). In an
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eye irritation study on rabbits, ferric
sodium EDTA was classified as mildly
irritating to the eye. The active
ingredient was instilled into the right
eye of three healthy rabbits. Twenty four
hours after instillation, conjunctivitis
and corneal opacity were observed.
Conjunctivitis cleared in all test animals
by Day 10, and corneal opacity persisted
in one test animal through Day 21. No
iritis was observed in any treated eye
during the study.
5. Primary Dermal Irritation (OPPTS
Harmonized Guideline 870.2500). In a
skin irritation study on rabbits, ferric
sodium EDTA was classified as slightly
irritating to the skin. The active
ingredient was applied to the skin of
healthy rabbits for 4 hours. No edema
was noted at any test site during the
study. One hour after test material
application all treated sites exhibited
erythema. All animals were free of
dermal irritation by 24 hours.
6. Dermal sensitization (OPPTS
Harmonized Guideline 870.2600). In a
dermal sensitization study on guinea
pigs, ferric sodium EDTA was not
considered to be a contact sensitizer.
The active ingredient was topically
applied to test animals once a week for
a 3–week induction period, and 28 days
after the first induction dose as a
challenge dose at the highest nonirritation concentration. No positive
responses were observed.
A waiver is requested for subchronic,
teratogenicity, genotoxicity and
immunotoxicity data requirements. The
active ingredient, ferric sodium EDTA,
is comprised of iron in a sodium EDTA
chelate. Ferric sodium EDTA is a
commodity ingredient used in the
photographic industry as a bleaching
agent, used in agriculture as a
micronutrient, and used in the chemical
industry as a catalyst. Ferric sodium
EDTA is also currently being evaluated
as a way of fortifying foods to prevent
anemia and iron deficiencies in
developing countries. Iron is an
essential element for nutrition and is
listed as GRAS for direct addition to
food per 21 CFR 184.1375. Sodium
EDTA is a common chelating agent,
which immobilizes metal ions until in
an environment where they are
available for uptake. Sodium EDTA is
exempt per 40 CFR 180.1001 when used
in pesticide formulations, and is a direct
food additive per 21 CFR 172.135.
A complete literature search was
conducted on ferric sodium EDTA, its
components and related compounds. In
a safety assessment of ferric sodium
EDTA (also referred to as ‘‘iron EDTA’’)
for Food and Drug Administration
(FDA) GRAS evaluation, the ingredient
is regarded as safe for use in foods to
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increase iron bioavailability in human
diets (Heimbach et al. 2000).
The results of toxicity testing and
information found in published
literature indicate there is no risk to
human health or the environment from
ferric sodium EDTA. Both dietary and
non-dietary exposures would not be
expected to pose any quantifiable risk
due to a lack of residues of toxicological
concern.
D. Aggregate Exposure
1. Dietary exposure—i. Food. Dietary
exposure from use of ferric sodium
EDTA, as proposed, is minimal. Ferric
sodium EDTA is intended for
application to soil surfaces in
agricultural crops, turf and ornamentals,
and home gardens to control slugs and
snails. The product is not applied
directly to fruits, vegetables, or plant
surfaces.
Ferric sodium EDTA is a commodity
ingredient used in the photographic
industry as a bleaching agent, used in
agriculture as a micronutrient, and used
in the chemical industry as a catalyst.
Ferric sodium EDTA is also currently
being evaluated as a way of fortifying
foods to prevent anemia and iron
deficiencies in developing countries.
The components of ferric sodium EDTA
are approved as direct food additives by
FDA. Acute toxicity studies have shown
that ferric sodium EDTA is not toxic or
irritating to mammals. Further, a
published safety assessment on ferric
sodium EDTA for FDA GRAS
evaluation, the ingredient is regarded as
safe for use in foods to increase iron
bioavailability in human diets
(Heimbach et al. 2000),
The results of toxicity testing and
information found in published
literature indicate there is no risk to
human health or the environment from
ferric sodium EDTA. Dietary exposures
would not be expected to pose any
quantifiable risk due to a lack of
residues of toxicological concern.
ii. Drinking water. Similarly, exposure
to humans from residues of ferric
sodium EDTA in consumed drinking
water would be unlikely. Potential
exposure to surface water would be
negligible and exposure to drinking
water (well or ground water) would be
impossible to measure. Ferric sodium
EDTA is intended for application to soil
surfaces in agricultural crops, turf and
ornamentals, and home gardens to
control slugs and snails. The product is
not applied directly to water.
The results of toxicity testing and
information found in published
literature indicate there is no risk to
human health or the environment from
ferric sodium EDTA. Drinking water
VerDate jul<14>2003
18:08 Jun 07, 2005
Jkt 205001
exposures would not be expected to
pose any quantifiable risk due to a lack
of residues of toxicological concern.
2. Non-dietary exposure. The
potential for non-dietary exposure to the
general population, including infants
and children, is limited. Ferric sodium
EDTA is intended for application to soil
surfaces in agricultural crops, turf and
ornamentals, and home gardens to
control slugs and snails.
The results of toxicity testing and
information found in published
literature indicate there is no risk to
human health or the environment from
ferric sodium EDTA. Non-dietary
exposures would not be expected to
pose any quantifiable risk due to a lack
of residues of toxicological concern.
E. Cumulative Exposure
It is not expected that, when used as
proposed, ferric sodium EDTA would
result in residues that are of
toxicological concern. Ferric sodium
EDTA is a commodity ingredient used
in the photographic industry as a
bleaching agent, used in agriculture as
a micronutrient, and used in the
chemical industry as a catalyst. Ferric
sodium EDTA is also currently being
evaluated as a way of fortifying foods to
prevent anemia and iron deficiencies in
developing countries. The components
of ferric sodium EDTA are approved as
direct food additives by FDA. Acute
toxicity studies have shown that ferric
sodium EDTA is not toxic or irritating
to mammals. Further, a published safety
assessment on ferric sodium EDTA for
FDA GRAS evaluation, the ingredient is
regarded as safe for use in foods to
increase iron bioavailability in human
diets (Heimbach et al. 2000).
Ferric sodium EDTA is intended for
application to soil surfaces in
agricultural crops, turf and ornamentals,
and home gardens to control slugs and
snails. The results of toxicity testing and
information found in published
literature indicate there is no risk to
human health or the environment from
ferric sodium EDTA.
F. Safety Determination
1. U.S. population. Ferric sodium
EDTA is a commodity ingredient used
in the photographic industry as a
bleaching agent, used in agriculture as
a micronutrient, and used in the
chemical industry as a catalyst. Ferric
sodium EDTA is also currently being
evaluated as a way of fortifying foods to
prevent anemia and iron deficiencies in
developing countries. The components
of ferric sodium EDTA are approved as
direct food additives by FDA. Acute
toxicity studies have shown that ferric
sodium EDTA is not toxic or irritating
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
to mammals. Further, a published safety
assessment on ferric sodium EDTA for
FDA GRAS evaluation, the ingredient is
regarded as safe for use in foods to
increase iron bioavailability in human
diets (Heimbach et al. 2000).
When used as proposed, ferric sodium
EDTA would not result in residues that
are of toxicological concern. Ferric
sodium EDTA is intended for
application to soil surfaces in
agricultural crops, turf and ornamentals,
and home gardens to control slugs and
snails. The results of toxicity testing and
information found in published
literature indicate there is no risk to
human health or the environment from
ferric sodium EDTA. There is a
reasonable certainty of no harm to the
general U.S. population from exposure
to this active ingredient.
2. Infants and children. As mentioned
above, it is not expected that, when
used as proposed, ferric sodium EDTA
would result in residues that are of
toxicological concern. There is a
reasonable certainty of no harm for
infants and children from exposure to
ferric sodium EDTA from the proposed
uses.
G. Effects on the Immune and Endocrine
Systems
To date there is no evidence to
suggest that ferric sodium EDTA
functions in a manner similar to any
known hormone, or that it acts as an
endocrine disrupter.
H. Existing Tolerances
There is no EPA tolerance for ferric
sodium EDTA.
I. International Tolerances
A Codex Alimentarium Commission
Maximum Residue Level (MRL) is not
required for ferric sodium EDTA.
[FR Doc. 05–11165 Filed 6–7–05; 8:45 am]
BILLING CODE 6560–50–S
FEDERAL COMMUNICATIONS
COMMISSION
[Report No. AUC–05–81–E (Auction No. 81);
DA 05–1337]
Auction of Low Power Television
Construction Permits Scheduled for
September 14, 2005, Notice and Filing
Requirements, Minimum Opening Bids,
Upfront Payments and Other
Procedures for Auction No. 81
Federal Communications
Commission.
ACTION: Notice.
AGENCY:
SUMMARY: This document announces the
procedures and minimum opening bids
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 70, Number 109 (Wednesday, June 8, 2005)]
[Notices]
[Pages 33474-33478]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-11165]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
[OPP-2005-0131; FRL-7715-5]
Ferric Sodium EDTA; 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.
-----------------------------------------------------------------------
SUMMARY: This notice announces the initial filing of a pesticide
petition
[[Page 33475]]
proposing the establishment of regulations for residues of a certain
pesticide chemical in or on various food commodities.
DATES: Comments, identified by docket identification (ID) number OPP-
2005-0131, must be received on or before July 8, 2005.
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: Todd Peterson, Biopesticides and
Pollution Prevention Division (7511C), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number: (703) 308-7224; e-mail
address: peterson.todd@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this Action Apply to Me?
You may be potentially affected by this action if you an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS 111)
Animal production (NAICS 112)
Food manufacturing (NAICS 311)
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 identification (ID) number OPP-2005-0131. 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,
1801 S. Bell St., 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 https://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 https://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.1.
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 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,
[[Page 33476]]
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 https://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-2005-0131. 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-2005-0131. 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-2005-0131.
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, 1801 S. Bell St., Arlington, VA, Attention: Docket ID
number OPP-2005-0131. 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: May 24, 2005.
Janet L. Andersen,
Director, Biopesticides and Pollution Prevention 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 the Woodstream Corporation 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.
Woodstream Corporation
PP 5F6899
EPA has received a pesticide petition (PP 5F6899) from Woodstream
Corporation, 69 N. Locust Street, Lititz, PA 17543-0327, 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 the biochemical
pesticide ferric sodium EDTA.
Pursuant to section 408(d)(2)(A)(i) of the FFDCA, as amended,
Woodstream Corporation has submitted the following summary of
information, data, and arguments in support of their pesticide
petition. This summary was prepared by Woodstream Corporation and EPA
has not fully evaluated the merits of the pesticide petition. The
summary may have been edited by EPA if the terminology used was
unclear, the summary contained extraneous material, or the summary
unintentionally made the reader conclude that the findings reflected
[[Page 33477]]
EPA's position and not the position of the petitioner.
A. Product Name and Proposed Use Practices
Ferric sodium EDTA (technical grade active ingredient) and slug
and snail killer (end-use product). Ferric sodium EDTA is a highly
efficacious replacement for metaldehyde for the control of snails and
slugs. The proposed end-use product (slug and snail killer) contains
6.00% active ingredient in a flour-based pellet. All intentionally
added inert ingredients are exempt from the requirement of a tolerance
when used in pesticides and are on EPA's List 4. Use sites proposed
include agricultural crops, turf and ornamentals and home gardens; all
areas where slugs and snails are a problem. The end-use product is
applied directly to the soil surface. A draft end-use product label has
been submitted with the corresponding application for FIFRA section 3
registration.
B. Product Identity/Chemistry
1. Identity of the pesticide and corresponding residues. The active
ingredient, ferric sodium EDTA, is comprised of iron in a sodium EDTA
chelate. Ferric sodium EDTA is a commodity ingredient used in the
photographic industry as a bleaching agent, used in agriculture as a
micronutrient, and used in the chemical industry as a catalyst. Ferric
sodium EDTA is also currently being evaluated as a way of fortifying
foods to prevent anemia and iron deficiencies in developing countries.
Iron is an essential element for nutrition and is listed as GRAS for
direct addition to food per 21 CFR 184.1375. Sodium EDTA is a common
chelating agent, which immobilizes metal ions until in an environment
where they are available for uptake. Sodium EDTA is exempt per 40 CFR
180.1001 when used in pesticide formulations, and is a direct food
additive per 21 CFR 172.135.
Ferric sodium EDTA has been classified as ``Not a biochemical, but
eligible for a reduced data set'' per the Agency's letter received May
16, 2001. EPA states the classification is based on the abundance of
iron in nature, its low toxicity, its use as a nutritional supplement,
and it slow water solubility.
The end-use product Snail and Slug Control is formulated in pellet
form with food attractants (flour-based ingredients). Snails and slugs
are attracted to and ingest the pellets. When ingested, the iron in
ferric sodium EDTA is available for uptake into the mollusks gut.
Normally iron is prevented from passing through the gut barrier;
however, the formulation of iron with the chelating agent EDTA allows
for iron to pass the gut barrier. Once passed, the iron partially
acidifies the mollusks copper-based blood resulting in sickness. The
mollusk stops feeding and leaves the area.
2. Magnitude of residue at the time of harvest and method used to
determine the residue.
3. A statement of why an analytical method for detecting and
measuring the levels of the pesticide residue are not needed. An
analytical method for residues is not applicable. It is expected that,
when used as proposed, ferric sodium EDTA would not result in residues
that are of toxicological concern.
C. Mammalian Toxicological Profile
Studies to evaluate the safety to mammals were conducted on the
technical grade active ingredient (tgai) and are summarized as follows:
1. Acute oral toxicity (OPPTS Harmonized Guideline 870.1100): No
adverse effects were seen in rats that received an oral gavage dose of
5,000 milligrams/kilogram body weight (mg/kg bwt) of the technical
grade active ingredient. No rats died during the 14-day observation
period, and no gross pathological changes were found in organs in the
thoracic or abdominal cavities at necropsy. A LD50 >5,000
mg/kg was established.
2. Acute dermal toxicity (OPPTS Harmonized Guideline 870.1200): No
adverse effects were seen in rats that received a dermal dose of 5,000
mg/kg bwt of the technical grade active ingredient. No effects on
appearance, behavior or body weight were observed in any rats any time
after exposure. No rats died during the 14-day observation period, and
no gross pathological changes were found in organs in the thoracic or
abdominal cavities at necropsy. A LD50 >5,000 mg/kg was
established.
3. Acute inhalation toxicity (OPPTS Harmonized Guideline 870.1300).
No adverse effects were seen in rats that were exposed by inhalation
for 4 hours to a concentration of 2.05 milligrams/Liter (mg/L) of the
technical grade active ingredient. No effects on appearance, behavior
or body weight were observed in any rats any time after exposure. No
rats died during the 14-day observation period, and no gross
pathological changes were found in organs in the thoracic or abdominal
cavities at necropsy. A LD50 >2.05 mg/L was established.
4. Primary eye irritation (OPPTS Harmonized Guideline 870.2400). In
an eye irritation study on rabbits, ferric sodium EDTA was classified
as mildly irritating to the eye. The active ingredient was instilled
into the right eye of three healthy rabbits. Twenty four hours after
instillation, conjunctivitis and corneal opacity were observed.
Conjunctivitis cleared in all test animals by Day 10, and corneal
opacity persisted in one test animal through Day 21. No iritis was
observed in any treated eye during the study.
5. Primary Dermal Irritation (OPPTS Harmonized Guideline 870.2500).
In a skin irritation study on rabbits, ferric sodium EDTA was
classified as slightly irritating to the skin. The active ingredient
was applied to the skin of healthy rabbits for 4 hours. No edema was
noted at any test site during the study. One hour after test material
application all treated sites exhibited erythema. All animals were free
of dermal irritation by 24 hours.
6. Dermal sensitization (OPPTS Harmonized Guideline 870.2600). In a
dermal sensitization study on guinea pigs, ferric sodium EDTA was not
considered to be a contact sensitizer. The active ingredient was
topically applied to test animals once a week for a 3-week induction
period, and 28 days after the first induction dose as a challenge dose
at the highest non-irritation concentration. No positive responses were
observed.
A waiver is requested for subchronic, teratogenicity, genotoxicity
and immunotoxicity data requirements. The active ingredient, ferric
sodium EDTA, is comprised of iron in a sodium EDTA chelate. Ferric
sodium EDTA is a commodity ingredient used in the photographic industry
as a bleaching agent, used in agriculture as a micronutrient, and used
in the chemical industry as a catalyst. Ferric sodium EDTA is also
currently being evaluated as a way of fortifying foods to prevent
anemia and iron deficiencies in developing countries. Iron is an
essential element for nutrition and is listed as GRAS for direct
addition to food per 21 CFR 184.1375. Sodium EDTA is a common chelating
agent, which immobilizes metal ions until in an environment where they
are available for uptake. Sodium EDTA is exempt per 40 CFR 180.1001
when used in pesticide formulations, and is a direct food additive per
21 CFR 172.135.
A complete literature search was conducted on ferric sodium EDTA,
its components and related compounds. In a safety assessment of ferric
sodium EDTA (also referred to as ``iron EDTA'') for Food and Drug
Administration (FDA) GRAS evaluation, the ingredient is regarded as
safe for use in foods to
[[Page 33478]]
increase iron bioavailability in human diets (Heimbach et al. 2000).
The results of toxicity testing and information found in published
literature indicate there is no risk to human health or the environment
from ferric sodium EDTA. Both dietary and non-dietary exposures would
not be expected to pose any quantifiable risk due to a lack of residues
of toxicological concern.
D. Aggregate Exposure
1. Dietary exposure--i. Food. Dietary exposure from use of ferric
sodium EDTA, as proposed, is minimal. Ferric sodium EDTA is intended
for application to soil surfaces in agricultural crops, turf and
ornamentals, and home gardens to control slugs and snails. The product
is not applied directly to fruits, vegetables, or plant surfaces.
Ferric sodium EDTA is a commodity ingredient used in the
photographic industry as a bleaching agent, used in agriculture as a
micronutrient, and used in the chemical industry as a catalyst. Ferric
sodium EDTA is also currently being evaluated as a way of fortifying
foods to prevent anemia and iron deficiencies in developing countries.
The components of ferric sodium EDTA are approved as direct food
additives by FDA. Acute toxicity studies have shown that ferric sodium
EDTA is not toxic or irritating to mammals. Further, a published safety
assessment on ferric sodium EDTA for FDA GRAS evaluation, the
ingredient is regarded as safe for use in foods to increase iron
bioavailability in human diets (Heimbach et al. 2000),
The results of toxicity testing and information found in published
literature indicate there is no risk to human health or the environment
from ferric sodium EDTA. Dietary exposures would not be expected to
pose any quantifiable risk due to a lack of residues of toxicological
concern.
ii. Drinking water. Similarly, exposure to humans from residues of
ferric sodium EDTA in consumed drinking water would be unlikely.
Potential exposure to surface water would be negligible and exposure to
drinking water (well or ground water) would be impossible to measure.
Ferric sodium EDTA is intended for application to soil surfaces in
agricultural crops, turf and ornamentals, and home gardens to control
slugs and snails. The product is not applied directly to water.
The results of toxicity testing and information found in published
literature indicate there is no risk to human health or the environment
from ferric sodium EDTA. Drinking water exposures would not be expected
to pose any quantifiable risk due to a lack of residues of
toxicological concern.
2. Non-dietary exposure. The potential for non-dietary exposure to
the general population, including infants and children, is limited.
Ferric sodium EDTA is intended for application to soil surfaces in
agricultural crops, turf and ornamentals, and home gardens to control
slugs and snails.
The results of toxicity testing and information found in published
literature indicate there is no risk to human health or the environment
from ferric sodium EDTA. Non-dietary exposures would not be expected to
pose any quantifiable risk due to a lack of residues of toxicological
concern.
E. Cumulative Exposure
It is not expected that, when used as proposed, ferric sodium EDTA
would result in residues that are of toxicological concern. Ferric
sodium EDTA is a commodity ingredient used in the photographic industry
as a bleaching agent, used in agriculture as a micronutrient, and used
in the chemical industry as a catalyst. Ferric sodium EDTA is also
currently being evaluated as a way of fortifying foods to prevent
anemia and iron deficiencies in developing countries. The components of
ferric sodium EDTA are approved as direct food additives by FDA. Acute
toxicity studies have shown that ferric sodium EDTA is not toxic or
irritating to mammals. Further, a published safety assessment on ferric
sodium EDTA for FDA GRAS evaluation, the ingredient is regarded as safe
for use in foods to increase iron bioavailability in human diets
(Heimbach et al. 2000).
Ferric sodium EDTA is intended for application to soil surfaces in
agricultural crops, turf and ornamentals, and home gardens to control
slugs and snails. The results of toxicity testing and information found
in published literature indicate there is no risk to human health or
the environment from ferric sodium EDTA.
F. Safety Determination
1. U.S. population. Ferric sodium EDTA is a commodity ingredient
used in the photographic industry as a bleaching agent, used in
agriculture as a micronutrient, and used in the chemical industry as a
catalyst. Ferric sodium EDTA is also currently being evaluated as a way
of fortifying foods to prevent anemia and iron deficiencies in
developing countries. The components of ferric sodium EDTA are approved
as direct food additives by FDA. Acute toxicity studies have shown that
ferric sodium EDTA is not toxic or irritating to mammals. Further, a
published safety assessment on ferric sodium EDTA for FDA GRAS
evaluation, the ingredient is regarded as safe for use in foods to
increase iron bioavailability in human diets (Heimbach et al. 2000).
When used as proposed, ferric sodium EDTA would not result in
residues that are of toxicological concern. Ferric sodium EDTA is
intended for application to soil surfaces in agricultural crops, turf
and ornamentals, and home gardens to control slugs and snails. The
results of toxicity testing and information found in published
literature indicate there is no risk to human health or the environment
from ferric sodium EDTA. There is a reasonable certainty of no harm to
the general U.S. population from exposure to this active ingredient.
2. Infants and children. As mentioned above, it is not expected
that, when used as proposed, ferric sodium EDTA would result in
residues that are of toxicological concern. There is a reasonable
certainty of no harm for infants and children from exposure to ferric
sodium EDTA from the proposed uses.
G. Effects on the Immune and Endocrine Systems
To date there is no evidence to suggest that ferric sodium EDTA
functions in a manner similar to any known hormone, or that it acts as
an endocrine disrupter.
H. Existing Tolerances
There is no EPA tolerance for ferric sodium EDTA.
I. International Tolerances
A Codex Alimentarium Commission Maximum Residue Level (MRL) is not
required for ferric sodium EDTA.
[FR Doc. 05-11165 Filed 6-7-05; 8:45 am]
BILLING CODE 6560-50-S
