Sodium Ferric Ethylenediaminetetraacetate; Exemption From the Requirement of a Tolerance, 17556-17561 [2011-7465]
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beginning actual construction) whether
a significant net emissions increase will
occur at the major stationary source (i.e.,
the second step of the process) is
contained in the definition in paragraph
(b)(3) of this section. Regardless of any
such preconstruction projections, a
major modification results if the project
causes a significant emissions increase
and a significant net emissions increase.
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(b) * * *
(3) * * *
(iii) * * *
(b) The increase or decrease in
emissions did not occur at a Clean Unit
except as provided in paragraphs (x)(8)
and (y)(10) of this section.
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(20) Fugitive emissions means those
emissions which could not reasonably
pass through a stack, chimney, vent, or
other functionally equivalent opening.
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(41) * * *
(ii) * * *
(b) Shall include fugitive emissions to
the extent quantifiable, and emissions
associated with startups, shutdowns,
and malfunctions; and
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(d) In lieu of using the method set out
in paragraphs (a)(41)(ii)(a) through (c) of
this section, may elect to use the
emissions unit’s potential to emit, in
tons per year, as defined under
paragraph (b)(4) of this section.
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(48) * * *
(i) * * *
(a) The average rate shall include
fugitive emissions to the extent
quantifiable, and emissions associated
with startups, shutdowns, and
malfunctions.
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(ii) * * *
(a) The average rate shall include
fugitive emissions to the extent
quantifiable, and emissions associated
with startups, shutdowns, and
malfunctions.
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(iii) For a new emissions unit, the
baseline actual emissions for purposes
of determining the emissions increase
that will result from the initial
construction and operation of such unit
shall equal zero; and thereafter, for all
other purposes, shall equal the unit’s
potential to emit.
(iv) For a PAL for a stationary source,
the baseline actual emissions shall be
calculated for existing electric utility
steam generating units in accordance
with the procedures contained in
paragraph (b)(48)(i) of this section, for
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other existing emissions units in
accordance with the procedures
contained in paragraph (b)(48)(ii) of this
section, and for a new emissions unit in
accordance with the procedures
contained in paragraph (b)(48)(iii) of
this section.
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(i) * * *
(1) * * *
(vii) The source or modification
would be a major stationary source or
major modification only if fugitive
emissions, to the extent quantifiable, are
considered in calculating the potential
to emit of the stationary source or
modification and the source does not
belong to any of the following
categories:
(a) Coal cleaning plants (with thermal
dryers);
(b) Kraft pulp mills;
(c) Portland cement plants;
(d) Primary zinc smelters;
(e) Iron and steel mills;
(f) Primary aluminum ore reduction
plants;
(g) Primary copper smelters;
(h) Municipal incinerators capable of
charging more than 250 tons of refuse
per day;
(i) Hydrofluoric, sulfuric, or nitric
acid plants;
(j) Petroleum refineries;
(k) Lime plants;
(l) Phosphate rock processing plants;
(m) Coke oven batteries;
(n) Sulfur recovery plants;
(o) Carbon black plants (furnace
process);
(p) Primary lead smelters;
(q) Fuel conversion plants;
(r) Sintering plants;
(s) Secondary metal production
plants;
(t) Chemical process plants—The term
chemical processing plant shall not
include ethanol production facilities
that produce ethanol by natural
fermentation included in NAICS codes
325193 or 312140;
(u) Fossil-fuel boilers (or combination
thereof) totaling more than 250 million
British thermal units per hour heat
input;
(v) Petroleum storage and transfer
units with a total storage capacity
exceeding 300,000 barrels;
(w) Taconite ore processing plants;
(x) Glass fiber processing plants;
(y) Charcoal production plants;
(z) Fossil fuel-fired steam electric
plants of more than 250 million British
thermal units per hour heat input;
(aa) Any other stationary source
category which, as of August 7, 1980, is
being regulated under section 111 or
112 of the Act; or
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(r) * * *
(6) * * *
(iii) The owner or operator shall
monitor the emissions of any regulated
NSR pollutant that could increase as a
result of the project and that is emitted
by any emissions unit identified in
paragraph (r)(6)(i)(b) of this section; and
calculate and maintain a record of the
annual emissions, in tons per year on a
calendar year basis, for a period of 5
years following resumption of regular
operations after the change, or for a
period of 10 years following resumption
of regular operations after the change if
the project increases the design capacity
or potential to emit that regulated NSR
pollutant at such emissions unit.
(iv) If the unit is an existing electric
utility steam generating unit, the owner
or operator shall submit a report to the
Administrator within 60 days after the
end of each year during which records
must be generated under paragraph
(r)(6)(iii) of this section setting out the
unit’s annual emissions during the
calendar year that preceded submission
of the report.
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(aa) * * *
(4) * * *
(i) * * *
(d) The PAL shall include fugitive
emissions, to the extent quantifiable,
from all emissions units that emit or
have the potential to emit the PAL
pollutant at the major stationary source.
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[FR Doc. 2011–6670 Filed 3–29–11; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2010–0097; FRL–8867–7]
Sodium Ferric
Ethylenediaminetetraacetate;
Exemption From the Requirement of a
Tolerance
Environmental Protection
Agency (EPA).
ACTION: Final rule.
AGENCY:
This regulation establishes an
exemption from the requirement of a
tolerance for residues of sodium ferric
ethylenediaminetetraacetate (EDTA) in
or on all food commodities when
applied as a molluscicide and used in
accordance with good agricultural
practices. W. Neudorff GmbH KG
submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act
(FFDCA), requesting an exemption from
SUMMARY:
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the requirement of a tolerance. This
regulation eliminates the need to
establish a maximum permissible level
for residues of sodium ferric EDTA
under the FFDCA.
DATES: This regulation is effective
March 30, 2011. Objections and requests
for hearings must be received on or
before May 31, 2011, and must be filed
in accordance with the instructions
provided in 40 CFR part 178 (see also
Unit I.C. of the SUPPLEMENTARY
INFORMATION).
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.
EPA has established a
docket for this action under docket
identification (ID) number EPA–HQ–
OPP–2010–0097. All documents in the
docket are listed in the docket index
available at https://www.regulations.gov.
Although listed in the index, some
information is not publicly available,
e.g., Confidential Business Information
(CBI) or other information whose
disclosure is restricted by statute.
Certain other material, such as
copyrighted material, is not placed on
the Internet and will be publicly
available only in hard copy form.
Publicly available docket materials are
available in the electronic docket at
https://www.regulations.gov, or, if only
available in hard copy, at the Office of
Pesticide Programs (OPP) Regulatory
Public Docket in Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. The Docket
Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal
holidays. The Docket Facility telephone
number is (703) 305–5805.
FOR FURTHER INFORMATION CONTACT: John
Fournier, Biopesticides and Pollution
Prevention Division (7511P),
Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington,
DC 20460–0001; telephone number:
(703) 308–0169; e-mail address:
fournier.john@epa.gov.
B. How can I get electronic access to
other related Information?
You may access a frequently updated
electronic version of 40 CFR part 180
through the Government Printing
Office’s e-CFR site at https://
www.gpoaccess.gov/ecfr. To access the
harmonized test guidelines referenced
in this document electronically, please
go to https://www.epa.gov/oscpp and
select ‘‘Test Methods and Guidelines.’’
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. General Information
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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:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
This listing is not intended to be
exhaustive, but rather provides a guide
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C. How can I file an objection or hearing
request?
Under FFDCA section 408(g), 21
U.S.C. 346a(g), any person may file an
objection to any aspect of this regulation
and may also request a hearing on those
objections. You must file your objection
or request a hearing on this regulation
in accordance with the instructions
provided in 40 CFR part 178. To ensure
proper receipt by EPA, you must
identify docket ID number EPA–HQ–
OPP–2010–0097 in the subject line on
the first page of your submission. All
objections and requests for a hearing
must be in writing, and must be
received by the Hearing Clerk on or
before May 31, 2011. Addresses for mail
and hand delivery of objections and
hearing requests are provided in 40 CFR
178.25(b).
In addition to filing an objection or
hearing request with the Hearing Clerk
as described in 40 CFR part 178, please
submit a copy of the filing that does not
contain any CBI for inclusion in the
public docket. Information not marked
confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA
without prior notice. Submit a copy of
your non-CBI objection or hearing
request, identified by docket ID number
EPA–HQ–OPP–2010–0097, by one of
the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the on-line
instructions for submitting comments.
• Mail: OPP Regulatory Public Docket
(7502P), Environmental Protection
Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460–0001.
• Delivery: OPP Regulatory Public
Docket (7502P), Environmental
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17557
Protection Agency, Rm. S–4400, One
Potomac Yard (South Bldg.), 2777 S.
Crystal Dr., Arlington, VA. Deliveries
are only accepted during the Docket
Facility’s normal hours of operation
(8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays).
Special arrangements should be made
for deliveries of boxed information. The
Docket Facility telephone number is
(703) 305–5805.
II. Background and Statutory Findings
In the Federal Register of September
30, 2010 (75 FR 60452) (FRL–8837–2),
EPA issued a notice pursuant to section
408(d)(3) of FFDCA, 21 U.S.C.
346a(d)(3), announcing the filing of a
pesticide tolerance petition (PP 9F7668)
by W. Neudorff GmbH KG, An der
¨
Muhle 3, Postfach 1209, 31860
Emmerthal, Germany (c/o Walter G.
Talarek, P.C., 1008 Riva Ridge Dr., Great
Falls, VA 22066–1620). The petition
requested that 40 CFR part 180 be
amended by establishing an exemption
from the requirement of a tolerance for
residues of sodium ferric EDTA. This
notice referenced a summary of the
petition prepared by the petitioner, W.
Neudorff GmbH KG, which is available
in the docket, https://
www.regulations.gov. There were no
comments received in response to the
notice of filing.
Section 408(c)(2)(A)(i) of FFDCA
allows EPA to establish an exemption
from the requirement for a tolerance (the
legal limit for a pesticide chemical
residue in or on a food) only if EPA
determines that the exemption is ‘‘safe.’’
Section 408(c)(2)(A)(ii) of FFDCA
defines ‘‘safe’’ to mean that ‘‘there is a
reasonable certainty that no harm will
result from aggregate exposure to the
pesticide chemical residue, including
all anticipated dietary exposures and all
other exposures for which there is
reliable information.’’ This includes
exposure through drinking water and in
residential settings, but does not include
occupational exposure. Pursuant to
section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an
exemption from the requirement of a
tolerance, EPA must take into account
the factors set forth in section
408(b)(2)(C) of FFDCA, which require
EPA to give special consideration to
exposure of infants and children to the
pesticide chemical residue in
establishing a tolerance and to ‘‘ensure
that there is a reasonable certainty that
no harm will result to infants and
children from aggregate exposure to the
pesticide chemical residue.’’
Additionally, section 408(b)(2)(D) of
FFDCA requires that the Agency
consider ‘‘available information
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concerning the cumulative effects of a
particular pesticide’s residues’’ and
‘‘other substances that have a common
mechanism of toxicity.’’
EPA performs a number of analyses to
determine the risks from aggregate
exposure to pesticide residues. First,
EPA determines the toxicity of
pesticides. Second, EPA examines
exposure to the pesticide through food,
drinking water, and through other
exposures that occur as a result of
pesticide use in residential settings.
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III. Toxicological Profile
Consistent with section 408(b)(2)(D)
of FFDCA, EPA has reviewed the
available scientific data and other
relevant information in support of this
action and considered its validity,
completeness, and reliability and the
relationship of this information to
human risk. EPA has also considered
available information concerning the
variability of the sensitivities of major
identifiable subgroups of consumers,
including infants and children.
A. Overview of Sodium Ferric EDTA
The pesticidal active ingredient,
sodium ferric EDTA, is a molluscicide
that has historically been used to
control terrestrial slugs and snails in
agriculture and on ornamental
landscaping. The compound is
comprised of iron in a sodium chelate.
This chelate forms a soluble, complex
molecule with iron ions, inactivating
the ions so that they cannot normally
react with other elements or ions to
produce precipitates or scale. In this
form, the iron is more bioavailable than
in other mineral sources (Ref. 1).
Bioavailability of iron is an essential
quality of sodium ferric EDTA as the
iron in this compound is responsible for
controlling slugs and snails. That is,
when slugs or snails ingest sodium
ferric EDTA, the iron in the compound
interacts with hemocyanin, a copperbased respiratory protein common to the
blood of mollusks and responsible for
their oxygen transport. This interaction
with hemocyanin causes suffocation
and eventually results in the death of
slugs and snails. Iron does not have this
interaction, however, in organisms that
do not use hemocyanin for oxygen
transport (e.g., mammals).
Iron is a necessary nutrient for all
mammals and other vertebrates because
it is a component of hemoglobin, the
oxygen transport protein found in red
blood cells of vertebrates. It is the most
abundant element on Earth and, as such,
can be found in most soil and water. It
is an essential nutrient listed as
Generally Recognized as Safe (GRAS) by
the Food and Drug Administration
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(FDA) for direct addition to food (21
CFR 184.1375) and is added to
commonly consumed, fortified foods
such as enriched flour, bread, pasta, and
grains. Sodium Ferric EDTA is allowed
as a direct food additive by the FDA and
is used as a source of iron for nutritional
fortification in foods such as powdered
meal replacements, flavored milk, and
fruit-flavored beverages (Ref. 2), as well
as soy, fish, teriyaki, and hoisin sauces
(Ref. 3). The compound is also a
common constituent of many cosmetic
products and, despite being present at
much higher concentrations than those
found in sodium ferric EDTA end-use
pesticide products used for control of
slugs and snails, has an extensive
history of safe use as an agricultural
fertilizer.
In 2008, EPA registered the first
sodium ferric EDTA-containing product
for control of slugs and snails. EPA
assessed the risks to human health and
concluded that, when sodium ferric
EDTA was used in accordance with
widespread and commonly recognized
practices, no unreasonable adverse
effects on the environment were
expected (Ref. 4). At the time of this
initial sodium ferric EDTA registration,
the applicant did not petition EPA to
establish a tolerance or tolerance
exemption because all uses were nonfood. On December 6, 2009, however,
EPA was petitioned by W. Neudorff
GmbH KG to establish an exemption
from the requirement of a tolerance for
residues of sodium ferric EDTA in or on
all food commodities. Accordingly, EPA
has completed a risk assessment of
mammalian toxicology data submitted
in support of this request. The overall
conclusions from these data are
described in Unit III.B., while more indepth synopses of the study results can
be found in the risk assessment and
Biopesticides Registration Action
Document provided as references in
Unit IX. (Refs. 5 and 6).
B. Biochemical Pesticide Human Health
Assessment Data Requirements
1. Acute toxicity. Tier I acute toxicity
studies of technical grade sodium ferric
EDTA (Slugkil MP, containing 71.42%
sodium ferric EDTA) showed that the
active ingredient is a Toxicity Category
III (slightly toxic) compound via the oral
and dermal routes of exposure, a
Toxicity Category III (slightly irritating)
compound via the dermal and eye
routes of exposure, and a Toxicity
Category IV (practically nontoxic)
compound for inhalation exposure.
Moreover, sodium ferric EDTA is not a
dermal sensitizer. Given the results of
these studies, no additional toxicity
(i.e., Tiers II or III) or residue data are
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required to support food uses of this
biochemical active ingredient. These
acute toxicity studies confirm sodium
ferric EDTA’s low toxicity profile.
i. The acute oral median lethal dose
(LD50) for sodium ferric EDTA in rats
was greater than 2,000 milligrams per
kilogram (mg/kg) and confirmed low
toxicity through oral exposure (Master
Record Identification Number (MRID
No.) 47942507). Sodium Ferric EDTA is
classified as Toxicity Category III for
acute oral toxicity.
ii. The acute dermal LD50 for sodium
ferric EDTA in rats was greater than
2,000 mg/kg, which confirmed low
dermal toxicity (MRID No. 47942508).
Sodium Ferric EDTA is classified as
Toxicity Category III for acute dermal
toxicity.
iii. The acute inhalation median lethal
concentration (LC50) for sodium ferric
EDTA in rats was greater than 2.75
milligrams per liter (mg/L) and showed
practically no inhalation toxicity (MRID
No. 47942512). Sodium Ferric EDTA is
classified as Toxicity Category IV for
acute inhalation toxicity.
iv. A primary eye irritation study
showed that exposure to sodium ferric
EDTA will cause temporary, mild eye
irritation (MRID No. 47942509).
Accordingly, EPA has determined that
sodium ferric EDTA is Toxicity Category
III for primary eye irritation.
v. A primary dermal irritation study
showed that exposure to sodium ferric
EDTA is slightly irritating (MRID No.
47942510) and a skin sensitization
study showed that sodium ferric EDTA
is not a sensitizer to the skin (MRID No.
47942511). Accordingly, EPA has
determined that sodium ferric EDTA is
Toxicity Category III for dermal
irritation.
2. Subchronic toxicity.—i. Submission
of 90-day oral toxicity data was waived
by EPA because the acute oral toxicity
study demonstrated sodium ferric
EDTA’s low toxicity (LD50 >2,000 .mg/
kg). In their waiver rationale, the
petitioner also cited information from
EPA’s 2008 sodium ferric EDTA
Biopesticides Registration Action
Document (BRAD):
No references for feeding studies using
sodium ferric EDTA were located in the
published literature. Rats fed low mineral
diets with or without calcium disodium
EDTA for four months had reduced weight
gain, but their general condition was
comparable to that of controls (Ref. 7). Rats
fed 1%, 5%, or 10% disodium salt of EDTA
for 90 days had significantly lower food
consumption and weight gain than controls
(Ref. 8). Hematology was comparable among
all groups, except that prothrombin time was
increased in the 10% group. The only
significant necropsy finding was pale livers
in the 10% group.
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Mice fed 3,750 or 7,500 ppm trisodium
EDTA for 103 weeks had no treatment-related
clinical signs, and gross and microscopic
pathology were unremarkable (Ref. 9). A
companion study conducted by NCI using
rats produced the same results (Ref. 9). In a
12-month feeding study using dogs, Oser et
al (1963) found no significant changes in
hematology or urinalysis parameters, and no
abnormal gross or microscopic findings in
groups receiving up to 250 mg/kg body
weight/day of calcium disodium EDTA (Ref.
10).
The information cited above refers to
feeding studies using sodium EDTA and
calcium disodium EDTA. The Agency has
assessed the toxicity profile of these and
other EDTA salts (Refs. 11 and 12), and
concluded that they are closely related. This
information sufficed for the assessment of
toxicological risk characterization of sodium
ferric EDTA.
Additionally, iron is an essential
nutrient listed as GRAS by the FDA, and
both iron and sodium ferric EDTA are
allowed as direct food additives to
increase the nutritional content of food
and food supplements. Sodium Ferric
EDTA is also used in agriculture as a
fertilizer. Given all of this information,
EPA concluded that no subchronic oral
toxicity is expected when this
compound is used in accordance with
good agricultural practices.
ii. Submission of 90-day dermal
toxicity data was waived by EPA
because acute guideline studies
demonstrated that sodium ferric EDTA
has low dermal toxicity (LD50 >2,000
mg/kg), is a slight dermal irritant, and
is not a dermal sensitizer. Repeated
dermal exposure, under conditions of
product use at a concentration that
could be toxic, is not anticipated.
iii. Submission of 90-day inhalation
data was waived by EPA because the
acute inhalation toxicity study
demonstrated sodium ferric EDTA’s lack
of toxicity (Toxicity Category IV).
Repeated inhalation exposure, under
conditions of product use at a
concentration that could be toxic, is not
anticipated.
3. Developmental toxicity and
mutagenicity. Acceptable waiver
requests were submitted to address the
data requirements for Developmental
toxicity and Mutagenicity (OPPTS
870.3700). The Agency concluded that
humans are regularly exposed to iron
found abundantly in nature and from
the use of sodium ferric EDTA as
fertilizer. No negative effects of sodium
ferric EDTA have been reported because
of its low toxicity and low water
solubility, which decreases its
absorption in the intestine. Moreover,
the active ingredient is not a mutagen
nor is it related to any known classes of
mutagens. After considering the
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aforementioned information and the
extensive history of use of sodium ferric
EDTA in agriculture and food without
deleterious effects, EPA waived the
requirement to submit developmental
toxicity and mutagenicity data.
IV. Aggregate Exposures
In examining aggregate exposure,
section 408 of FFDCA directs EPA to
consider available information
concerning exposures from the pesticide
residue in food and all other nonoccupational exposures, including
drinking water from ground water or
surface water and exposure through
pesticide use in gardens, lawns, or
buildings (residential and other indoor
uses).
A. Dietary Exposure
1. Food. The primary route of sodium
ferric EDTA exposure to the general
population will be through
consumption of food; however, there is
no reason to expect that practical use of
sodium ferric EDTA, in accordance with
good agricultural practices, will
constitute any significant hazard.
Sodium Ferric EDTA is comprised of
iron in a sodium chelate. Iron is
abundant in nature, an essential
nutrient, and listed as GRAS for direct
addition to food (21 CFR 184.1375).
Sodium Ferric EDTA is regarded as safe
for use as a dietary supplement to
increase iron bioavailability and prevent
iron deficiency. In humans, iron is an
essential nutrient that is vital to the
processes by which cells generate
energy. It is available to animals from
food derived from other animals and
plants.
When sodium ferric EDTA is ingested,
the chelate holds the iron in the
stomach until pH rises in the upper
small intestine. As pH rises, the strength
of the complex progressively
diminishes, allowing exchange with
other metals and iron for absorption.
Iron dissociates from the EDTA moiety
and is released in the duodenum prior
to absorption. Only a very small fraction
of the sodium ferric EDTA complex (less
than 1%) is absorbed intact. Intact
EDTA metal complexes are rapidly
excreted; they do not accumulate or
undergo biotransformation (Ref. 13).
European Food Safety Authority
Panel on Food Additives and Nutrient
Sources added to Food (2010)
concluded that, when sodium ferric
EDTA is used in food supplements at
levels that provide 22.3 milligrams (mg)
of iron/day for adults and 11.1 mg of
iron/day for children, the use of sodium
ferric EDTA as a source of iron in foods
is of no safety concern as long as it does
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17559
not lead to an exposure of EDTA above
1.9 mg/kg/day.
Exposure to EDTA and salts of EDTA
already occurs through certain FDAapproved uses as food additives, in
sanitizing solutions, and in
pharmaceutical products, or through
their use in soaps, shampoos, or
cosmetics. EDTA has also been
administered safely under medical
supervision as treatment for heavy metal
poisoning. The results of toxicity testing
and information found in public
literature indicate that there is no risk
to human health from residues of
sodium ferric EDTA in food crops.
Furthermore, residues from the
formulations in agricultural use sites
(certified limits <4% by weight) and
residential use sites (<1% of typical
formulations) are not likely to exceed
levels currently consumed in commonly
eaten foods. In addition, the use of
EDTA and EDTA salts in pesticide
products is expected to result in much
lower exposure than the FDA-regulated
use of these compounds, as well as
lower exposure than their use in
pharmaceuticals or cosmetic products.
The concentration of iron needed for
good plant growth is below the
concentration needed by animals for
good cellular functioning. In agriculture,
iron sodium chelate is used as
micronutrient fertilizer at much higher
concentrations than those present in
sodium ferric EDTA-containing
pesticide products, which are labeled
for maximum application rates of below
25 mg of sodium ferric EDTA per square
foot. The use of sodium ferric EDTA in
pesticides is expected to result in much
lower exposure than through its use in
plant fertilizers, pharmaceutical
products, or cosmetic products. Based
on review and evaluation of available
information, EPA concludes that there is
a reasonable certainty of no harm from
residues of sodium ferric EDTA when
applied as a molluscicide and used in
accordance with good agricultural
practices.
2. Drinking water exposure. No
significant drinking water exposure or
residues are expected to result from the
use of sodium ferric EDTA as a
molluscicide. The active ingredient is
intended for use directly on food
commodities or the soil around crops
and is not to be applied directly to
water. If used in accordance with EPAapproved labeling and good agricultural
practices, sodium ferric EDTA is not
likely to accumulate in drinking water.
Overall, exposures from residues in
drinking water are unlikely and are not
expected to pose a quantifiable risk due
to environmental fate of sodium ferric
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EDTA and lack of residues of
toxicological concerns.
B. Other Non-Occupational Exposure
The potential for non-dietary
exposure of the general population,
including infants and children, is
limited based on the use patterns of
sodium ferric EDTA. The end use
products containing sodium ferric
EDTA are granules or pellets that do not
produce any dust and are applied
directly to the ground. Therefore, it is
unlikely that there will be any dermal
or inhalation exposure when the
product is applied according to the label
use directions. Furthermore, sodium
ferric EDTA was demonstrated to be
practically non-toxic (Toxicity Category
IV) to rats in an acute dermal toxicity
guideline study (MRID 45848104) and
practically non-toxic (Toxicity Category
IV) to rats in an acute inhalation toxicity
guideline study (MRID 45848105). Nondietary exposures are not expected to
pose any quantifiable risk to the general
population.
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V. Cumulative Effects From Substances
With a Common Mechanism of Toxicity
Section 408(b)(2)(D)(v) of FFDCA
requires that, when considering whether
to establish, modify, or revoke a
tolerance, the Agency consider
‘‘available information’’ concerning the
cumulative effects of a particular
pesticide’s residues and ‘‘other
substances that have a common
mechanism of toxicity.’’
EPA has not found sodium ferric
EDTA to share a common mechanism of
toxicity with any other substances, and
sodium ferric EDTA does not appear to
produce a toxic metabolite as its mode
of action against the target pests. For the
purposes of this tolerance action,
therefore, EPA has assumed that sodium
ferric EDTA does not have a common
mechanism of toxicity with other
substances. For information regarding
EPA’s efforts to determine which
chemicals have a common mechanism
of toxicity and to evaluate the
cumulative effects of such chemicals,
see EPA’s Web site at https://
www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S.
Population, Infants and Children
FFDCA section 408(b)(2)(C) provides
that EPA shall assess the available
information about consumption patterns
among infants and children, special
susceptibility of infants and children to
pesticide chemical residues, and the
cumulative effects on infants and
children of the residues and other
substances with a common mechanism
of toxicity. In addition, FFDCA section
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Jkt 223001
408(b)(2)(C) provides that EPA shall
apply an additional tenfold margin of
safety for infants and children in the
case of threshold effects to account for
prenatal and postnatal toxicity and the
completeness of the database unless
EPA determines that a different margin
of safety will be safe for infants and
children. Margins of exposure (safety),
which are often referred to as
uncertainty factors, are incorporated
into EPA risk assessments either
directly or through the use of a margin
of exposure analysis, or by using
uncertainty (safety) factors in
calculating a dose level that poses no
appreciable risk.
Based on the results of the
toxicological data discussed in Unit
III.B., as well as all other available
information, EPA concludes that there is
a reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to the residues of sodium
ferric EDTA. This includes all
anticipated dietary exposures and all
other exposures for which there is
reliable information. EPA has arrived at
this conclusion based on the low level
of toxicity of the compound, the
minimal exposure from application/use
of sodium ferric EDTA as a
molluscicide, and the already
widespread exposure through use as a
fertilizer and food additive without any
reported adverse effects on human
health. Thus, there are no threshold
effects of concern and, as a result, an
additional margin of safety is not
necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required
for enforcement purposes since the
Agency is establishing an exemption
from the requirement of a tolerance
without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA
seeks to harmonize U.S. tolerances with
international standards whenever
possible, consistent with U.S. food
safety standards and agricultural
practices. EPA considers the
international maximum residue limits
(MRLs) established by the Codex
Alimentarius Commission (Codex), as
required by FFDCA section 408(b)(4).
The Codex Alimentarius is a joint
United Nations Food and Agriculture
Organization/World Health
Organization food standards program,
and it is recognized as an international
food safety standards-setting
organization in trade agreements to
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which the United States is a party. EPA
may establish a tolerance that is
different from a Codex MRL; however,
FFDCA section 408(b)(4) requires that
EPA explain the reasons for departing
from the Codex level. The Codex has not
established a MRL for sodium ferric
EDTA.
VIII. Conclusions
EPA concludes that there is a
reasonable certainty that no harm will
result to the U.S. population, including
infants and children, from aggregate
exposure to residues of sodium ferric
EDTA. Therefore, an exemption is
established for residues of sodium ferric
EDTA in or on all food commodities
when applied as a molluscicide and
used in accordance with good
agricultural practices.
IX. References
1. Heimbach J, Rieth S, Mohamedshah F,
Slesinski R, Samuel-Fernando P,
Sheehan T, Dickmann R, Borzelleca J.
2000. Safety assessment of iron EDTA
sodium ion (Fe(3+))
ethylenediaminetetraacetic acid:
Summary of toxicological, fortification
and exposure data. Food Chemical
Toxicology 38(1):99–111.
2. U.S. FDA. 2006 Agency Response Letter
GRAS Notice No. GRN 000178 (Sodium
Iron EDTA). Available from: https://
www.fda.gov/Food/
FoodIngredientsPackaging/
GenerallyRecognizedasSafeGRAS/
GRASListings/ucm154622.htm.
3. U.S. FDA. 2004. Agency Response Letter
GRAS Notice No. GRN 000152 (Sodium
Iron EDTA). Available from: https://
www.fda.gov/Food/
FoodIngredientsPackaging/
GenerallyRecognizedasSafeGRAS/
GRASListings/ucm154378.htm.
4. U.S. EPA. 2008. Sodium Ferric EDTA
Biopesticides Registration Action
document dated November 20, 2008.
5. U.S. EPA. 2011. Dietary Risk Assessment
(Ferric Sodium EDTA). Memorandum
from C. Fuentes, PhD to J. Fournier dated
January 5, 2011.
6. U.S. EPA. 2011. Sodium Ferric EDTA
Biopesticides Registration Action
Document dated February 7, 2011
(available as ‘‘Supporting & Related
Materials’’ within Docket Number EPA–
HQ–OPP–2010–0144 at https://
www.regulations.gov).
7. Yang SS. 1964. Toxicology of EDTA. Food
Cosmetics Toxicology 2:763–765.
8. Wynn JE, Van’t Riet B, Borzelleca JF. 1970.
The toxicity and pharmacodynamics of
EGTA: oral administration to rats and
comparisons with EDTA. Toxicology
Applied Pharmacology 16(3):807–817.
9. National Cancer Institute. 1977. Bioassay
of trisodium ethylenediaminetetraacetate
trihydrate (EDTA) for possible
carcinogenicity: CAS No. 150–38–9.
Bethesda (MD): National Cancer
Institute, Carcinogenesis Program/
Research Triangle Park (NC): National
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Toxicology Program (NTP); Technical
Report Series No. 11.
10. Oser BL, Oser M, Spencer HC. 1963.
Safety evaluation studies of calcium
EDTA. Toxicology Applied
Pharmacology 5:142–162.
11. U.S. EPA. 2004. Recommendation for
Tolerance Reassessment for
Ethylenediaminetetraacetic Acid (EDTA)
and various ammonium, calcium,
copper, iron, potassium, manganese,
sodium and zinc salts of EDTA.
Memorandum from K. Boyle to
B. Shackleford dated January 28, 2004.
12. U.S. EPA. 2004.
Ethylenediaminetetraacetic acid (EDTA)
and the salts of EDTA: Science
Assessment Document for Tolerance
Reassessment. Memorandum from E.
Reaves to K. Boyle dated January 26,
2004.
13. European Food Safety Authority Panel on
Food Additives and Nutrient Sources
added to Food 2010. Scientific opinion
on the use of ferric sodium EDTA as a
source of iron added for nutritional
purposes to foods for the general
population (including food supplements)
and to foods for particular nutritional
uses. EFSA Journal 8(1):1414.
WReier-Aviles on DSKGBLS3C1PROD with RULES
X. Statutory and Executive Order
Reviews
This final rule establishes a tolerance
under section 408(d) of FFDCA in
response to a petition submitted to the
Agency. The Office of Management and
Budget (OMB) has exempted these types
of actions from review under Executive
Order 12866, entitled Regulatory
Planning and Review (58 FR 51735,
October 4, 1993). Because this final rule
has been exempted from review under
Executive Order 12866, this final rule is
not subject to Executive Order 13211,
entitled Actions Concerning Regulations
That Significantly Affect Energy Supply,
Distribution, or Use (66 FR 28355, May
22, 2001) or Executive Order 13045,
entitled Protection of Children From
Environmental Health Risks and Safety
Risks (62 FR 19885, April 23, 1997).
This final rule does not contain any
information collections subject to OMB
approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et
seq., nor does it require any special
considerations under Executive Order
12898, entitled Federal Actions To
Address Environmental Justice in
Minority Populations and Low-Income
Populations (59 FR 7629, February 16,
1994).
Since tolerances and exemptions that
are established on the basis of a petition
under section 408(d) of FFDCA, such as
the tolerance in this final rule, do not
require the issuance of a proposed rule,
the requirements of the Regulatory
Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
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This final rule directly regulates
growers, food processors, food handlers,
and food retailers, not States or tribes,
nor does this action alter the
relationships or distribution of power
and responsibilities established by
Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such,
the Agency has determined that this
action will not have a substantial direct
effect on States or tribal governments,
on the relationship between the national
government and the States or tribal
governments, or on the distribution of
power and responsibilities among the
various levels of government or between
the Federal Government and Indian
tribes. Thus, the Agency has determined
that Executive Order 13132, entitled
Federalism (64 FR 43255, August 10,
1999) and Executive Order 13175,
entitled Consultation and Coordination
with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply
to this final rule. In addition, this final
rule does not impose any enforceable
duty or contain any unfunded mandate
as described under Title II of the
Unfunded Mandates Reform Act of 1995
(UMRA) (Pub. L. 104–4).
This action does not involve any
technical standards that would require
Agency consideration of voluntary
consensus standards pursuant to section
12(d) of the National Technology
Transfer and Advancement Act of 1995
(NTTAA), Public Law 104–113, section
12(d) (15 U.S.C. 272 note).
XI. Congressional Review Act
The Congressional Review Act, 5
U.S.C. 801 et seq., generally provides
that before a rule may take effect, the
agency promulgating the rule must
submit a rule report to each House of
the Congress and to the Comptroller
General of the United States. EPA will
submit a report containing this rule and
other required information to the
U.S. Senate, the U.S. House of
Representatives, and the Comptroller
General of the United States prior to
publication of this final rule in the
Federal Register. This final rule is not
a ‘‘major rule’’ as defined by 5 U.S.C.
804(2).
List of Subjects in 40 CFR Part 180
Environmental protection,
Administrative practice and procedure,
Agricultural commodities, Pesticides
and pests, Reporting and recordkeeping
requirements.
Dated: March 17, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is
amended as follows:
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17561
PART 180—[AMENDED]
1. The authority citation for part 180
continues to read as follows:
■
Authority: 21 U.S.C. 321(q), 346a and 371.
2. Section 180.1302 is added to
subpart D to read as follows:
■
§ 180.1302 Sodium Ferric
Ethylenediaminetetraacetate (EDTA);
exemption from the requirement of a
tolerance.
An exemption from the requirement
of a tolerance is established for residues
of sodium ferric EDTA in or on all food
commodities when applied as a
molluscicide and used in accordance
with good agricultural practices.
[FR Doc. 2011–7465 Filed 3–29–11; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
46 CFR Part 160
[USCG–2011–0076]
RIN 1625–AB60
Inflatable Personal Flotation Devices
Coast Guard, DHS.
Direct final rule; request for
comments.
AGENCY:
ACTION:
By this direct final rule, the
Coast Guard is harmonizing structural
and performance standards for inflatable
recreational personal flotation devices
(PFDs) with current voluntary industry
consensus standards. This direct final
rule also slightly modifies regulatory
text in anticipation of a future
rulemaking addressing the population
for which inflatable recreational PFDs
are approved, but does not change the
current affected population.
DATES: This rule is effective September
26, 2011 unless an adverse comment, or
notice of intent to submit an adverse
comment, is either submitted to our
online docket via https://
www.regulations.gov on or before May
31, 2011 or reaches the Docket
Management Facility by that date. If an
adverse comment, or notice to submit an
adverse comment, is received by May
31, 2011, we will withdraw this direct
final rule and publish a timely notice of
withdrawal in the Federal Register. The
incorporation by reference of certain
publications listed in the rule is
approved by the Director of the Federal
Register on September 26, 2011.
ADDRESSES: You may submit comments
identified by docket number USCG–
SUMMARY:
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]]>Agencies
[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Rules and Regulations]
[Pages 17556-17561]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7465]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0097; FRL-8867-7]
Sodium Ferric Ethylenediaminetetraacetate; Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of sodium ferric
ethylenediaminetetraacetate (EDTA) in or on all food commodities when
applied as a molluscicide and used in accordance with good agricultural
practices. W. Neudorff GmbH KG submitted a petition to EPA under the
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption
from
[[Page 17557]]
the requirement of a tolerance. This regulation eliminates the need to
establish a maximum permissible level for residues of sodium ferric
EDTA under the FFDCA.
DATES: This regulation is effective March 30, 2011. Objections and
requests for hearings must be received on or before May 31, 2011, and
must be filed in accordance with the instructions provided in 40 CFR
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2010-0097. All documents in the
docket are listed in the docket index available at https://www.regulations.gov. Although listed in the index, some information is
not publicly available, e.g., Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
Internet and will be publicly available only in hard copy form.
Publicly available docket materials are available in the electronic
docket at https://www.regulations.gov, or, if only available in hard
copy, at the Office of Pesticide Programs (OPP) Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal
Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: John Fournier, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-0169; e-mail address: fournier.john@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:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 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 electronic access to other related Information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at https://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to https://www.epa.gov/oscpp and select ``Test Methods and Guidelines.''
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2010-0097 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
May 31, 2011. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing that does not contain any CBI for inclusion in the public
docket. Information not marked confidential pursuant to 40 CFR part 2
may be disclosed publicly by EPA without prior notice. Submit a copy of
your non-CBI objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2010-0097, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: OPP Regulatory Public Docket (7502P), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of September 30, 2010 (75 FR 60452) (FRL-
8837-2), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 9F7668) by W. Neudorff GmbH KG, An der M[uuml]hle 3,
Postfach 1209, 31860 Emmerthal, Germany (c/o Walter G. Talarek, P.C.,
1008 Riva Ridge Dr., Great Falls, VA 22066-1620). The petition
requested that 40 CFR part 180 be amended by establishing an exemption
from the requirement of a tolerance for residues of sodium ferric EDTA.
This notice referenced a summary of the petition prepared by the
petitioner, W. Neudorff GmbH KG, which is available in the docket,
https://www.regulations.gov. There were no comments received in response
to the notice of filing.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Pursuant to section 408(c)(2)(B) of FFDCA, in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
section 408(b)(2)(C) of FFDCA, which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue.''
Additionally, section 408(b)(2)(D) of FFDCA requires that the Agency
consider ``available information
[[Page 17558]]
concerning the cumulative effects of a particular pesticide's
residues'' and ``other substances that have a common mechanism of
toxicity.''
EPA performs a number of analyses to determine the risks from
aggregate exposure to pesticide residues. First, EPA determines the
toxicity of pesticides. Second, EPA examines exposure to the pesticide
through food, drinking water, and through other exposures that occur as
a result of pesticide use in residential settings.
III. Toxicological Profile
Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the
available scientific data and other relevant information in support of
this action and considered its validity, completeness, and reliability
and the relationship of this information to human risk. EPA has also
considered available information concerning the variability of the
sensitivities of major identifiable subgroups of consumers, including
infants and children.
A. Overview of Sodium Ferric EDTA
The pesticidal active ingredient, sodium ferric EDTA, is a
molluscicide that has historically been used to control terrestrial
slugs and snails in agriculture and on ornamental landscaping. The
compound is comprised of iron in a sodium chelate. This chelate forms a
soluble, complex molecule with iron ions, inactivating the ions so that
they cannot normally react with other elements or ions to produce
precipitates or scale. In this form, the iron is more bioavailable than
in other mineral sources (Ref. 1). Bioavailability of iron is an
essential quality of sodium ferric EDTA as the iron in this compound is
responsible for controlling slugs and snails. That is, when slugs or
snails ingest sodium ferric EDTA, the iron in the compound interacts
with hemocyanin, a copper-based respiratory protein common to the blood
of mollusks and responsible for their oxygen transport. This
interaction with hemocyanin causes suffocation and eventually results
in the death of slugs and snails. Iron does not have this interaction,
however, in organisms that do not use hemocyanin for oxygen transport
(e.g., mammals).
Iron is a necessary nutrient for all mammals and other vertebrates
because it is a component of hemoglobin, the oxygen transport protein
found in red blood cells of vertebrates. It is the most abundant
element on Earth and, as such, can be found in most soil and water. It
is an essential nutrient listed as Generally Recognized as Safe (GRAS)
by the Food and Drug Administration (FDA) for direct addition to food
(21 CFR 184.1375) and is added to commonly consumed, fortified foods
such as enriched flour, bread, pasta, and grains. Sodium Ferric EDTA is
allowed as a direct food additive by the FDA and is used as a source of
iron for nutritional fortification in foods such as powdered meal
replacements, flavored milk, and fruit-flavored beverages (Ref. 2), as
well as soy, fish, teriyaki, and hoisin sauces (Ref. 3). The compound
is also a common constituent of many cosmetic products and, despite
being present at much higher concentrations than those found in sodium
ferric EDTA end-use pesticide products used for control of slugs and
snails, has an extensive history of safe use as an agricultural
fertilizer.
In 2008, EPA registered the first sodium ferric EDTA-containing
product for control of slugs and snails. EPA assessed the risks to
human health and concluded that, when sodium ferric EDTA was used in
accordance with widespread and commonly recognized practices, no
unreasonable adverse effects on the environment were expected (Ref. 4).
At the time of this initial sodium ferric EDTA registration, the
applicant did not petition EPA to establish a tolerance or tolerance
exemption because all uses were non-food. On December 6, 2009, however,
EPA was petitioned by W. Neudorff GmbH KG to establish an exemption
from the requirement of a tolerance for residues of sodium ferric EDTA
in or on all food commodities. Accordingly, EPA has completed a risk
assessment of mammalian toxicology data submitted in support of this
request. The overall conclusions from these data are described in Unit
III.B., while more in-depth synopses of the study results can be found
in the risk assessment and Biopesticides Registration Action Document
provided as references in Unit IX. (Refs. 5 and 6).
B. Biochemical Pesticide Human Health Assessment Data Requirements
1. Acute toxicity. Tier I acute toxicity studies of technical grade
sodium ferric EDTA (Slugkil MP, containing 71.42% sodium ferric EDTA)
showed that the active ingredient is a Toxicity Category III (slightly
toxic) compound via the oral and dermal routes of exposure, a Toxicity
Category III (slightly irritating) compound via the dermal and eye
routes of exposure, and a Toxicity Category IV (practically nontoxic)
compound for inhalation exposure. Moreover, sodium ferric EDTA is not a
dermal sensitizer. Given the results of these studies, no additional
toxicity (i.e., Tiers II or III) or residue data are required to
support food uses of this biochemical active ingredient. These acute
toxicity studies confirm sodium ferric EDTA's low toxicity profile.
i. The acute oral median lethal dose (LD50) for sodium
ferric EDTA in rats was greater than 2,000 milligrams per kilogram (mg/
kg) and confirmed low toxicity through oral exposure (Master Record
Identification Number (MRID No.) 47942507). Sodium Ferric EDTA is
classified as Toxicity Category III for acute oral toxicity.
ii. The acute dermal LD50 for sodium ferric EDTA in rats
was greater than 2,000 mg/kg, which confirmed low dermal toxicity (MRID
No. 47942508). Sodium Ferric EDTA is classified as Toxicity Category
III for acute dermal toxicity.
iii. The acute inhalation median lethal concentration
(LC50) for sodium ferric EDTA in rats was greater than 2.75
milligrams per liter (mg/L) and showed practically no inhalation
toxicity (MRID No. 47942512). Sodium Ferric EDTA is classified as
Toxicity Category IV for acute inhalation toxicity.
iv. A primary eye irritation study showed that exposure to sodium
ferric EDTA will cause temporary, mild eye irritation (MRID No.
47942509). Accordingly, EPA has determined that sodium ferric EDTA is
Toxicity Category III for primary eye irritation.
v. A primary dermal irritation study showed that exposure to sodium
ferric EDTA is slightly irritating (MRID No. 47942510) and a skin
sensitization study showed that sodium ferric EDTA is not a sensitizer
to the skin (MRID No. 47942511). Accordingly, EPA has determined that
sodium ferric EDTA is Toxicity Category III for dermal irritation.
2. Subchronic toxicity.--i. Submission of 90-day oral toxicity data
was waived by EPA because the acute oral toxicity study demonstrated
sodium ferric EDTA's low toxicity (LD50 >2,000 .mg/kg). In
their waiver rationale, the petitioner also cited information from
EPA's 2008 sodium ferric EDTA Biopesticides Registration Action
Document (BRAD):
No references for feeding studies using sodium ferric EDTA were
located in the published literature. Rats fed low mineral diets with
or without calcium disodium EDTA for four months had reduced weight
gain, but their general condition was comparable to that of controls
(Ref. 7). Rats fed 1%, 5%, or 10% disodium salt of EDTA for 90 days
had significantly lower food consumption and weight gain than
controls (Ref. 8). Hematology was comparable among all groups,
except that prothrombin time was increased in the 10% group. The
only significant necropsy finding was pale livers in the 10% group.
[[Page 17559]]
Mice fed 3,750 or 7,500 ppm trisodium EDTA for 103 weeks had no
treatment-related clinical signs, and gross and microscopic
pathology were unremarkable (Ref. 9). A companion study conducted by
NCI using rats produced the same results (Ref. 9). In a 12-month
feeding study using dogs, Oser et al (1963) found no significant
changes in hematology or urinalysis parameters, and no abnormal
gross or microscopic findings in groups receiving up to 250 mg/kg
body weight/day of calcium disodium EDTA (Ref. 10).
The information cited above refers to feeding studies using
sodium EDTA and calcium disodium EDTA. The Agency has assessed the
toxicity profile of these and other EDTA salts (Refs. 11 and 12),
and concluded that they are closely related. This information
sufficed for the assessment of toxicological risk characterization
of sodium ferric EDTA.
Additionally, iron is an essential nutrient listed as GRAS by the
FDA, and both iron and sodium ferric EDTA are allowed as direct food
additives to increase the nutritional content of food and food
supplements. Sodium Ferric EDTA is also used in agriculture as a
fertilizer. Given all of this information, EPA concluded that no
subchronic oral toxicity is expected when this compound is used in
accordance with good agricultural practices.
ii. Submission of 90-day dermal toxicity data was waived by EPA
because acute guideline studies demonstrated that sodium ferric EDTA
has low dermal toxicity (LD50 >2,000 mg/kg), is a slight
dermal irritant, and is not a dermal sensitizer. Repeated dermal
exposure, under conditions of product use at a concentration that could
be toxic, is not anticipated.
iii. Submission of 90-day inhalation data was waived by EPA because
the acute inhalation toxicity study demonstrated sodium ferric EDTA's
lack of toxicity (Toxicity Category IV). Repeated inhalation exposure,
under conditions of product use at a concentration that could be toxic,
is not anticipated.
3. Developmental toxicity and mutagenicity. Acceptable waiver
requests were submitted to address the data requirements for
Developmental toxicity and Mutagenicity (OPPTS 870.3700). The Agency
concluded that humans are regularly exposed to iron found abundantly in
nature and from the use of sodium ferric EDTA as fertilizer. No
negative effects of sodium ferric EDTA have been reported because of
its low toxicity and low water solubility, which decreases its
absorption in the intestine. Moreover, the active ingredient is not a
mutagen nor is it related to any known classes of mutagens. After
considering the aforementioned information and the extensive history of
use of sodium ferric EDTA in agriculture and food without deleterious
effects, EPA waived the requirement to submit developmental toxicity
and mutagenicity data.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of FFDCA directs EPA
to consider available information concerning exposures from the
pesticide residue in food and all other non-occupational exposures,
including drinking water from ground water or surface water and
exposure through pesticide use in gardens, lawns, or buildings
(residential and other indoor uses).
A. Dietary Exposure
1. Food. The primary route of sodium ferric EDTA exposure to the
general population will be through consumption of food; however, there
is no reason to expect that practical use of sodium ferric EDTA, in
accordance with good agricultural practices, will constitute any
significant hazard.
Sodium Ferric EDTA is comprised of iron in a sodium chelate. Iron
is abundant in nature, an essential nutrient, and listed as GRAS for
direct addition to food (21 CFR 184.1375). Sodium Ferric EDTA is
regarded as safe for use as a dietary supplement to increase iron
bioavailability and prevent iron deficiency. In humans, iron is an
essential nutrient that is vital to the processes by which cells
generate energy. It is available to animals from food derived from
other animals and plants.
When sodium ferric EDTA is ingested, the chelate holds the iron in
the stomach until pH rises in the upper small intestine. As pH rises,
the strength of the complex progressively diminishes, allowing exchange
with other metals and iron for absorption. Iron dissociates from the
EDTA moiety and is released in the duodenum prior to absorption. Only a
very small fraction of the sodium ferric EDTA complex (less than 1%) is
absorbed intact. Intact EDTA metal complexes are rapidly excreted; they
do not accumulate or undergo biotransformation (Ref. 13).
European Food Safety Authority Panel on Food Additives and Nutrient
Sources added to Food (2010) concluded that, when sodium ferric EDTA is
used in food supplements at levels that provide 22.3 milligrams (mg) of
iron/day for adults and 11.1 mg of iron/day for children, the use of
sodium ferric EDTA as a source of iron in foods is of no safety concern
as long as it does not lead to an exposure of EDTA above 1.9 mg/kg/day.
Exposure to EDTA and salts of EDTA already occurs through certain
FDA-approved uses as food additives, in sanitizing solutions, and in
pharmaceutical products, or through their use in soaps, shampoos, or
cosmetics. EDTA has also been administered safely under medical
supervision as treatment for heavy metal poisoning. The results of
toxicity testing and information found in public literature indicate
that there is no risk to human health from residues of sodium ferric
EDTA in food crops. Furthermore, residues from the formulations in
agricultural use sites (certified limits <4% by weight) and residential
use sites (<1% of typical formulations) are not likely to exceed levels
currently consumed in commonly eaten foods. In addition, the use of
EDTA and EDTA salts in pesticide products is expected to result in much
lower exposure than the FDA-regulated use of these compounds, as well
as lower exposure than their use in pharmaceuticals or cosmetic
products.
The concentration of iron needed for good plant growth is below the
concentration needed by animals for good cellular functioning. In
agriculture, iron sodium chelate is used as micronutrient fertilizer at
much higher concentrations than those present in sodium ferric EDTA-
containing pesticide products, which are labeled for maximum
application rates of below 25 mg of sodium ferric EDTA per square foot.
The use of sodium ferric EDTA in pesticides is expected to result in
much lower exposure than through its use in plant fertilizers,
pharmaceutical products, or cosmetic products. Based on review and
evaluation of available information, EPA concludes that there is a
reasonable certainty of no harm from residues of sodium ferric EDTA
when applied as a molluscicide and used in accordance with good
agricultural practices.
2. Drinking water exposure. No significant drinking water exposure
or residues are expected to result from the use of sodium ferric EDTA
as a molluscicide. The active ingredient is intended for use directly
on food commodities or the soil around crops and is not to be applied
directly to water. If used in accordance with EPA-approved labeling and
good agricultural practices, sodium ferric EDTA is not likely to
accumulate in drinking water. Overall, exposures from residues in
drinking water are unlikely and are not expected to pose a quantifiable
risk due to environmental fate of sodium ferric
[[Page 17560]]
EDTA and lack of residues of toxicological concerns.
B. Other Non-Occupational Exposure
The potential for non-dietary exposure of the general population,
including infants and children, is limited based on the use patterns of
sodium ferric EDTA. The end use products containing sodium ferric EDTA
are granules or pellets that do not produce any dust and are applied
directly to the ground. Therefore, it is unlikely that there will be
any dermal or inhalation exposure when the product is applied according
to the label use directions. Furthermore, sodium ferric EDTA was
demonstrated to be practically non-toxic (Toxicity Category IV) to rats
in an acute dermal toxicity guideline study (MRID 45848104) and
practically non-toxic (Toxicity Category IV) to rats in an acute
inhalation toxicity guideline study (MRID 45848105). Non-dietary
exposures are not expected to pose any quantifiable risk to the general
population.
V. Cumulative Effects From Substances With a Common Mechanism of
Toxicity
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency
consider ``available information'' concerning the cumulative effects of
a particular pesticide's residues and ``other substances that have a
common mechanism of toxicity.''
EPA has not found sodium ferric EDTA to share a common mechanism of
toxicity with any other substances, and sodium ferric EDTA does not
appear to produce a toxic metabolite as its mode of action against the
target pests. For the purposes of this tolerance action, therefore, EPA
has assumed that sodium ferric EDTA does not have a common mechanism of
toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see EPA's Web site
at https://www.epa.gov/pesticides/cumulative.
VI. Determination of Safety for U.S. Population, Infants and Children
FFDCA section 408(b)(2)(C) provides that EPA shall assess the
available information about consumption patterns among infants and
children, special susceptibility of infants and children to pesticide
chemical residues, and the cumulative effects on infants and children
of the residues and other substances with a common mechanism of
toxicity. In addition, FFDCA section 408(b)(2)(C) provides that EPA
shall apply an additional tenfold margin of safety for infants and
children in the case of threshold effects to account for prenatal and
postnatal toxicity and the completeness of the database unless EPA
determines that a different margin of safety will be safe for infants
and children. Margins of exposure (safety), which are often referred to
as uncertainty factors, are incorporated into EPA risk assessments
either directly or through the use of a margin of exposure analysis, or
by using uncertainty (safety) factors in calculating a dose level that
poses no appreciable risk.
Based on the results of the toxicological data discussed in Unit
III.B., as well as all other available information, EPA concludes that
there is a reasonable certainty that no harm will result to the U.S.
population, including infants and children, from aggregate exposure to
the residues of sodium ferric EDTA. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. EPA has arrived at this conclusion based on the low level
of toxicity of the compound, the minimal exposure from application/use
of sodium ferric EDTA as a molluscicide, and the already widespread
exposure through use as a fertilizer and food additive without any
reported adverse effects on human health. Thus, there are no threshold
effects of concern and, as a result, an additional margin of safety is
not necessary.
VII. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established a MRL for sodium ferric EDTA.
VIII. Conclusions
EPA concludes that there is a reasonable certainty that no harm
will result to the U.S. population, including infants and children,
from aggregate exposure to residues of sodium ferric EDTA. Therefore,
an exemption is established for residues of sodium ferric EDTA in or on
all food commodities when applied as a molluscicide and used in
accordance with good agricultural practices.
IX. References
1. Heimbach J, Rieth S, Mohamedshah F, Slesinski R, Samuel-Fernando
P, Sheehan T, Dickmann R, Borzelleca J. 2000. Safety assessment of
iron EDTA sodium ion (Fe(3+)) ethylenediaminetetraacetic acid:
Summary of toxicological, fortification and exposure data. Food
Chemical Toxicology 38(1):99-111.
2. U.S. FDA. 2006 Agency Response Letter GRAS Notice No. GRN 000178
(Sodium Iron EDTA). Available from: https://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm154622.htm.
3. U.S. FDA. 2004. Agency Response Letter GRAS Notice No. GRN 000152
(Sodium Iron EDTA). Available from: https://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/ucm154378.htm.
4. U.S. EPA. 2008. Sodium Ferric EDTA Biopesticides Registration
Action document dated November 20, 2008.
5. U.S. EPA. 2011. Dietary Risk Assessment (Ferric Sodium EDTA).
Memorandum from C. Fuentes, PhD to J. Fournier dated January 5,
2011.
6. U.S. EPA. 2011. Sodium Ferric EDTA Biopesticides Registration
Action Document dated February 7, 2011 (available as ``Supporting &
Related Materials'' within Docket Number EPA-HQ-OPP-2010-0144 at
https://www.regulations.gov).
7. Yang SS. 1964. Toxicology of EDTA. Food Cosmetics Toxicology
2:763-765.
8. Wynn JE, Van't Riet B, Borzelleca JF. 1970. The toxicity and
pharmacodynamics of EGTA: oral administration to rats and
comparisons with EDTA. Toxicology Applied Pharmacology 16(3):807-
817.
9. National Cancer Institute. 1977. Bioassay of trisodium
ethylenediaminetetraacetate trihydrate (EDTA) for possible
carcinogenicity: CAS No. 150-38-9. Bethesda (MD): National Cancer
Institute, Carcinogenesis Program/Research Triangle Park (NC):
National
[[Page 17561]]
Toxicology Program (NTP); Technical Report Series No. 11.
10. Oser BL, Oser M, Spencer HC. 1963. Safety evaluation studies of
calcium EDTA. Toxicology Applied Pharmacology 5:142-162.
11. U.S. EPA. 2004. Recommendation for Tolerance Reassessment for
Ethylenediaminetetraacetic Acid (EDTA) and various ammonium,
calcium, copper, iron, potassium, manganese, sodium and zinc salts
of EDTA. Memorandum from K. Boyle to B. Shackleford dated January
28, 2004.
12. U.S. EPA. 2004. Ethylenediaminetetraacetic acid (EDTA) and the
salts of EDTA: Science Assessment Document for Tolerance
Reassessment. Memorandum from E. Reaves to K. Boyle dated January
26, 2004.
13. European Food Safety Authority Panel on Food Additives and
Nutrient Sources added to Food 2010. Scientific opinion on the use
of ferric sodium EDTA as a source of iron added for nutritional
purposes to foods for the general population (including food
supplements) and to foods for particular nutritional uses. EFSA
Journal 8(1):1414.
X. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled Regulatory Planning and
Review (58 FR 51735, October 4, 1993). Because this final rule has been
exempted from review under Executive Order 12866, this final rule is
not subject to Executive Order 13211, entitled Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
Protection of Children From Environmental Health Risks and Safety Risks
(62 FR 19885, April 23, 1997). This final rule does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it require any
special considerations under Executive Order 12898, entitled Federal
Actions To Address Environmental Justice in Minority Populations and
Low-Income Populations (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the tolerance in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of section 408(n)(4) of FFDCA. As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled Federalism (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (Pub. L. 104-4).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
XI. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. EPA will submit a report
containing this rule and other required information to the U.S. Senate,
the U.S. House of Representatives, and the Comptroller General of the
United States prior to publication of this final rule in the Federal
Register. This final rule is not a ``major rule'' as defined by 5
U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: March 17, 2011.
Steven Bradbury,
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. Section 180.1302 is added to subpart D to read as follows:
Sec. 180.1302 Sodium Ferric Ethylenediaminetetraacetate (EDTA);
exemption from the requirement of a tolerance.
An exemption from the requirement of a tolerance is established for
residues of sodium ferric EDTA in or on all food commodities when
applied as a molluscicide and used in accordance with good agricultural
practices.
[FR Doc. 2011-7465 Filed 3-29-11; 8:45 am]
BILLING CODE 6560-50-P
