[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Rules and Regulations]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-7465]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
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
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 http://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 http://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: email@example.com.
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
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 http://www.gpoaccess.gov/ecfr. To access the harmonized test guidelines
referenced in this document electronically, please go to http://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: http://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-
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,
http://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
concerning the cumulative effects of a particular pesticide's
residues'' and ``other substances that have a common mechanism of
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
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
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
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.
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
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
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
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
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
V. Cumulative Effects From Substances With a Common Mechanism of
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
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
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.
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.
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: http://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: http://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,
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
7. Yang SS. 1964. Toxicology of EDTA. Food Cosmetics Toxicology
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-
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):
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
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
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
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: March 17, 2011.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
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:
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
[FR Doc. 2011-7465 Filed 3-29-11; 8:45 am]
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