[Federal Register: March 8, 2006 (Volume 71, Number 45)]
[Proposed Rules]
[Page 11563-11570]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr06-25]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2005-0325; FRL-7750-8]
Ethylenediaminetetraacetic Acid Chemicals: Exemptions from the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: The Agency is proposing to establish 16 new and amend three
existing exemptions from the requirement of a tolerance for residues of
various ethylenediaminetetraacetic acid (EDTA) chemicals in or on raw
agricultural commodities when used as inert ingredients in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest under the Federal Food, Drug, and Cosmetic
Act (FFDCA), as amended by the Food Quality Protection Act of 1996
(FQPA). This regulation eliminates the need to establish a maximum
permissible level for residues of these EDTA chemicals.
DATES: Comments, identified by docket identification (ID) number EPA-
HQ-OPP-2005-0325, must be received on or before May 8, 2006.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2005-0325, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov/.
Follow the on-line instructions for submitting comments.
Agency Website: EDOCKET, EPA's electronic public and
comment system was replaced on November 25, 2005, by an enhanced
federal-wide electronic docket management and comment system located at
http://www.regulations.gov/. Follow the on-line instructions.
Mail: Public Information and Records Integrity Branch
(PIRIB) (7502C), Office of Pesticide Programs (OPP), Environmental
Protection Agency, 1200 Pennsylvania Ave., NW.,
[[Page 11564]]
Washington, DC 20460-0001, Attention: Docket ID Number EPA-HQ-OPP-2005-
0325.
Hand Delivery: Public Information and Records Integrity
Branch (PIRIB), Office of Pesticide Programs (OPP), Environmental
Protection Agency, Rm. 119, Crystal Mall 2, 1801 S. Bell St.,
Arlington, VA, Attention: Docket ID Number EPA-HQ-OPP-2005-0325. Such
deliveries are only accepted during the Docket's normal hours of
operation, and special arrangements should be made for deliveries of
boxed information.
Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2005-0325. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov/, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov your
e-mail address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses. For additional
information about EPA's public docket visit the EPA Docket Center
homepage athttp://www.epa.gov/epahome/dockets.html.
Docket: All documents in the docket are listed in the
http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, i.e., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically in http://www.regulations.gov or hard copy at the Public
Information and Records Integrity Branch (PIRIB), Rm. 119, Crystal Mall
2, 1801 S. Bell St., Arlington, VA. This Docket Facility is
open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal
holidays. The Docket telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Kathryn Boyle, Registration Division
(7505C), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave, NW., Washington, DC 20460-0001; telephone
number: (703) 305-6304; e-mail address: boyle.kathryn@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 Access Electronic Copies of this Document and Other
Related Information?
In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
``Federal Register'' listings at http://www.epa.gov/fedrgstr/. A
frequently updated electronic version of 40 CFR part 180 is available
on E-CFR Beta Site Two at http://www.gpoaccess.gov/ecfr/.
C. What Should I Consider as I Prepare My Comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
http://www.regulations.gov or e-mail. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD ROM that you mail to EPA, mark the outside of the disk or CD ROM as
CBI and then identify electronically within the disk or CD ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When submitting comments,
remember to:
i. Identify the rulemaking by docket number and other identifying
information (subject heading, Federal Register date, and page number).
ii. Follow directions. The agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
vi. Provide specific examples to illustrate your concerns, and
suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
viii. Make sure to submit your comments by the comment period
deadline identified.
II. What is the Agency's Authority for Taking this Action?
This proposed rule is issued under section 408 of FFDCA, 21 U.S.C.
346a, as amended by the Food Quality Protection Act of 1996 (FQPA)
(Public Law 104-170). Section 408(e) of FFDCA authorizes EPA to
establish, modify, or revoke tolerances, or exemptions from the
requirement of a tolerance for residues of pesticide chemicals in or on
raw agricultural commodities and processed foods.
III. What Action is the Agency Taking?
The Agency is proposing to establish 16 new and amend three
existing tolerance exemptions for several EDTA chemicals. Currently,
there are three tolerance exemptions for EDTA chemicals in 40 CFR
180.910: Disodium
[[Page 11565]]
zinc ethylenediaminetetraacetate dihydride, ethylenediaminetetraacetic
acid, and ethylenediaminetetraacetic acid, tetrasodium salt. These
exemptions are being amended to reflect a common nomenclature, add CAS
Reg. Nos., and/or a 5% limitation of all EDTA chemicals in the
pesticide product.
The tolerance exemptions for the tetrasodium salt and the disodium
zinc are considered to be for both the hydrated and anhydrous forms.
Thus, three of the new tolerance exemptions are for the hydrated forms
of the tetrasodium salt and the disodium zinc salt.
The EDTA chemicals are a group of man-made chelating (binding)
agents with a preferred affinity for heavier metals such as lead,
mercury, cadmium, zinc, and aluminum. EDTA's ability to complex, bind,
and remove such metals is used commercially to either promote or
inhibit chemical reactions, depending on the application. EDTA has also
been used under medical supervision to treat heavy metal poisoning.
Large doses of EDTA (or one of its salts) function to scavenge the
heavy metals from the body. EDTA preferentially binds with the heavy
metal present with the resultant complex then being excreted.
The EDTA chemicals which are the subject of this proposed rule, the
nomenclature which will be used and the CAS Reg. Nos. are in the Table
below. These chemicals were selected based on information in the
Agency's files which indicate use in pesticide products applied to
food-use sites.
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EDTA Chemical CAS Reg. No.
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Ethylenediaminetetraacetic acid (EDTA) 60-00-4
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Ethylenediaminetetraacetic acid (EDTA) calcium disodium salt 62-33-9
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Ethylenediaminetetraacetic acid (EDTA) disodium copper (II) salt 14025-15-1
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Ethylenediaminetetraacetic acid (EDTA) disodium copper (II) salt, 61916-40-3
dihydrate
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Ethylenediaminetetraacetic acid (EDTA) disodium copper (II) salt, 73637-19-1
trihydrate
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Ethylenediaminetetraacetic acid (EDTA) disodium manganese (II) 15375-84-5
salt
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Ethylenediaminetetraacetic acid (EDTA) disodium manganese (I) 73637-20-4
salt, dihydrate
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Ethylenediaminetetraacetic acid (EDTA) disodium salt 139-33-3
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Ethylenediaminetetraacetic acid (EDTA) disodium salt, dihydrate 6381-92-6
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Ethylenediaminetetraacetic acid (EDTA) disodium zinc salt 14025-21-9
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Ethylenediaminetetraacetic acid (EDTA) disodium zinc salt, 73513-47-0
dihydrate
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Ethylenediaminetetraacetic acid (EDTA) monosodium salt 17421-79-3
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Ethylenediaminetetraacetic acid (EDTA) sodium iron (III) salt 15708-41-5
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Ethylenediaminetetraacetic acid (EDTA) sodium salt 7379-28-4
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Ethylenediaminetetraacetic acid (EDTA) tetrapotassium salt 5964-35-2
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Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt 64-02-8
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Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt, 13235-36-4
tetrahydrate
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Ethylenediaminetetraacetic acid (EDTA) tetrasodium salt, 67401-50-7
trihydrate
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Ethylenediaminetetraacetic acid (EDTA) tripotassium salt 17572-97-3
----------------------------------------------------------------------------------------------------------------
IV. 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. The nature of the toxic effects caused by these
EDTA chemicals are summarized in this unit.
The data considered in this assessment included information located
by the Office of Pesticide Programs on the internet, studies conducted
by the National Toxicology Program (NTP) and the National Cancer
Institute (NCI), several work products produced by the Cosmetic
Ingredient Review, several evaluations by the World Health
Organization, and articles from open literature. The Agency's overall
conclusions are as follows; however, greater detail on the Agency's
review and evaluation of these EDTA chemicals are in the EDTA Science
Assessment, which is posted as a support document in the docket for
this action (see http://www.regulations.gov/). It is noted that the
Agency's review and evaluation covered a large group of 25 EDTA
chemicals in which the available data from all of the chemicals was
``pooled'' for use as surrogate data.
As a group, the EDTA chemicals are not acutely toxic via the oral
route of exposure. They are mild skin irritants and severe eye
irritants.
Mutagenicity studies such as the mouse lymphoma study were negative
for EDTA and its salts except for a few positive tests when
administered with sterile distilled water. Genotoxicity studies for
EDTA and its salts were
[[Page 11566]]
mixed positive and negative results, depending on assay type and cell
type.
Trisodium EDTA was tested in a 2-year carcinogenicity study by the
NCI. Their conclusions indicated that there were no compound-related
signs of chemical toxicity, and tumor incidence was not related to
treatment. This study was re-evaluated in 2003 with the conclusion that
``there is no concern for EDTA with regard to carcinogenicity.''
The Agency has evaluated 15 of the EDTA chemicals through the use
of structure-activity-relationship (SAR) assessments. With one
exception, these evaluations indicate no absorption of the EDTA
chemicals through the skin, but predicted good absorption through the
lungs and GI tract. The exception was EDTA, per se, which is expected
to be absorbed through all routes of exposure. The Team performing the
SARs indicated a low to moderate concern for human health effects. All
concerns noted were considered to be due to the chelation and eventual
excretion of metals such as calcium, magnesium, iron, and zinc in the
mammalian body.
Other reviews indicate that EDTA is not totally absorbed when
ingested. Various sources rate the absorption as poor to good with the
upper limit on absorption being defined numerically as 20%. Elimination
occurs mainly by the kidneys (95%) with some (5%) via the bile.
Various EDTA chemicals have been tested in repeated dose toxicity
studies which included doses of up to 5% of the diet. Only diarrhea and
lowered food consumption were reported in animals given 5% disodium
EDTA. Taken together, all of the repeated dose toxicity studies
reviewed indicate that the greatest risk in the mammalian body will
occur when the EDTA attempts to scavenge the trace metals used and
required by the body. The repeated conclusion of the various studies is
that rats fed a low percent of an EDTA chemical in the diet with
adequate minerals showed no signs of toxicity. The various
developmental studies indicate that developmental effects will occur if
the EDTA chemicals remove the necessary trace metals from the maternal
body, so that none are available for the developing fetus.
The Agency's review and evaluation of EDTA and its various salts
indicates that adverse effects occur only in the presence of mineral
deficiencies. In fact, the toxic effects of EDTA are considered to be
related to metal deficiencies, especially a deficiency of zinc.
However, two critical pieces of information informed the Agency's
evaluation of EDTA. Two developmental toxicity studies were performed
using disodium EDTA. The Agency has reviewed the toxicological
literature on both of these studies. In one study, rats were maintained
on de-ionized water (water containing no trace minerals) and a semi-
purified diet, and housed in nonmetallic caging. The test animals
displayed both maternal and developmental effects. In another very
similar study, rats that were maintained on tap water displayed no such
effects. Thus, the availability of trace metals, particularly zinc, in
the diet and drinking water work to prevent deficiencies.
Thus, test animals can consume large amounts of EDTA (up to 5% of
the diet) with no adverse effects, provided that the trace metals
needed by the body, are also included in the diet.
V. 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 additive uses. EDTA is used extensively as a food additive
to sequester trace metals that catalyze the oxidation of oils,
vitamins, and unsaturated fats that cause rancidity, flavor changes,
and discoloration. For the calcium disodium salt of EDTA an acceptable
daily intake of 2.5 milligram/kilogram (mg/kg) was established by the
Joint FAO/WHO Expert Committee on Food Additives (JECFA) in 1973.
In the U.S., in food the permissible levels of the calcium disodium
salt of EDTA, as specified in 21 CFR 172.120, range from 25 to 800 ppm.
Use of calcium disodium EDTA as a food additive is permitted for direct
addition to food for human consumption, as long as (1) the quantity of
the substance added to food does not exceed the amount reasonably
required to accomplish its intended physical, nutritive, or other
technical effect in food, and (2) any substance intended for use in or
on food is of appropriate food grade, and is prepared and handled as a
food ingredient.
Disodium EDTA can also be used as a food additive for direct
addition to food for human consumption in specified foods, as specified
under 21 CFR 172.135.
For sodium iron EDTA, a provisional maximum tolerance daily intake
of 0.8 mg/kg/bodyweight was established by the Joint FAO/WHO Committee.
In 1981, an article in a toxicology journal reported that the
maximum human consumption of EDTA and its salts in foods was on the
order of 0.4 mg/kg/day.
2. Food contact surface sanitizing solutions. The disodium and
tetrasodium salts of EDTA are used in food contact surface sanitizing
solutions, as specified in 40 CFR 180.940. A screening-level exposure
estimate of this use was performed for the tetrasodium salt. The
estimated exposure is 0.005 mg/kg/day.
3. In pesticide products applied to agricultural crops. The Agency
is proposing to place a limitation of 5% of total EDTA in pesticide
products. This limit was based on information in the Agency's files. To
account for possible food residues as a result of application of an
inert ingredient in a pesticide product, the Agency has developed a
screening-level model for predicting dietary exposure to inert
ingredients. The model assumes that the inert ingredients are used on
all crops and 100% of all crops are ``treated'' with the inert
ingredient. The results of the model are considered to over-estimate
exposure to an inert ingredient in a pesticide product. The model is
scalable and can be adjusted to account for lower percent in
formulations. The scaled estimate for use of EDTA chemicals with a
limitation of 5% in the formulation is 0.006 mg/kg/day.
B. Drinking Water
EDTA is a strong organic acid (approximately 1,000 times stronger
than acetic acid). It has a high affinity for alkaline-earth ions (for
example, calcium and magnesium) and heavy-metal ions (for example, lead
and mercury). This affinity generally results in the formation of
highly stable and soluble complexes. The EDTA chemicals are soluble in
water, have low sorption to soil and sediments, have no significant
vapor pressure, and have a biodegradation half-life of weeks to months.
While EDTA chemicals are slow to degrade, aerobic biodegradation
(mineralization to carbon dioxide and water) is the dominant mechanism.
The rate of biodegradation of EDTA in soils is reported to vary
depending upon environmental factors such as pH, temperature, soil
classification, organic matter, and types and population of microbes.
There are significant releases of EDTA to the environment in
domestic sewage (from use in detergents, soaps, and
[[Page 11567]]
cleaning products) and industrial effluents (bleaching of textiles and
paper; processing of photographic material; electroplating; bottle
cleaning; and industrial cleaning of pipe and tank systems). Detergent
preparations are probably the predominant source of EDTA found in
domestic sewage, contributing an estimated 100 micrograms/Liter ([mu]g/
L) to the total concentration of EDTA in average sewage streams, with
smaller amounts probably originating from food and other consumer
products.
After treatment, the effluent from sewage treatment plants is
released to streams, rivers, and lakes, and is further diluted by the
receiving waters. According to Toxnet (see http://toxnet.nlm.nih.gov)
ethylenediamine tetraacetic acid has been detected in ground water
(ranging from 5 to 25 [mu]g/L), and drinking water derived from surface
water (10 to 45 [mu]g/L).
Using 45 [mu]g/L, the estimated exposure via drinking water is 1.5
[mu]g/kg/day or 0.0015 mg/kg/day for adult females and 4.5 [mu]g/kg/day
or 0.0045 mg/kg/day for children.
C. Other Non-Occupational
Several EDTA chemicals are used as chelating agents in cosmetics.
Examples of products containing EDTA chemicals include: bubble baths,
bath soaps and detergents, deodorants, facial makeups and lotions,
colognes and toilet waters, hair products (shampoos, rinses,
conditioners, dyes and colors), nail basecoats and undercoats, and nail
creams and lotions. EDTA chemicals are also used in cleaning products
and laundry detergents and to control the interactions of trace metals
in pharmaceuticals, metal working, pulp and paper processing, rubber
and polymer chemistry, and textile processing and dyeing.The available
information indicates that the non-food uses of EDTA are more prevalent
than the food-uses. The information in the Agency's files indicates
that pesticide products applied to residential use sites generally
contain less than 1% of EDTA in the formulated product.
Using this information on percents in formulation, the Agency has
estimated short-term screening level dermal exposure estimates for EDTA
chemicals using both EDTA, per se, and the tetrasodium salt of EDTA.
Since the screening level estimates were identical for both of these
chemicals, they can serve as surrogate estimates for all the EDTA
chemicals. Note that inhalation exposure estimates are not used since
the vapor pressure of EDTA chemicals is so low.
For a typical cleaning product, the estimated exposure
estimate is 0.028 mg/kg/day
For a typical laundry detergent, the estimated exposure
estimate is 0.0088 mg/kg/day
For a cosmetic product, the estimated exposure is 0.0008
mg/kg/day
These modeled exposure estimates indicate that the exposures that
could occur from the use of these EDTA chemicals in either residential
pesticidal or consumer non-pesticidal products are less than the levels
at which an adverse effect could occur.
VI. Cumulative Effects
Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance or tolerance
exemption, the Agency consider ``available information'' concerning the
cumulative effects of a particular chemical's residues and ``other
substances that have a common mechanism of toxicity.''
Unlike other pesticide chemicals for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to ethylene
diaminetetraacetic acid and its various salts. The EDTA chemicals are a
structurally-related group of chemicals, that travel through the
mammalian body and are excreted. For the purposes of this tolerance
action, therefore, EPA has not assumed that these chemical substances
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 the policy statements released by EPA's Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/
.
VII. Safety Factor for Infants and Children
FFDCA section 408 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 concluded that a different
margin of safety will be safe for infants and children.
EDTA chemicals are chelating agents or scavengers. Their function
is to locate and then bind to metals. Many metals (iron, zinc,
manganese) are required in the mammalian body in trace amounts for
proper functioning of the mammalian body. Lack of these metals, and
most particularly zinc, can lead to severe effects.
Various salts of EDTA have been tested in several developmental
toxicity studies. Based on developmental studies in lab rodents, EDTA
and salts should not posed a developmental concern. Results of a
developmental study indicate no developmental effects are likely in
rodents at doses up to 1,000 mg/kg/day. Adequate minerals in the diet
and administration of tap water prevented possible developmental
effects of EDTA during pregnancy. In a different developmental toxicity
study, developmental effects observed in lab rodents were likely due to
animals maintained on deionized water and a semi-purified diet, and
housed in nonmetallic caging. It is unlikely that infants and children
would be exposed to concentrations as high as the lab rodents studied.
The maximum human consumption of EDTA and its salts in foods was
reported to be on the order of 0.4 mg/kg/day. Infants and children,
also, generally drink tap water instead of deionized or distilled
water.
EDTA is also used therapeutically in adults and pregnant women. A
therapeutic dose of 1.2 to 2.0 grams per day is generally given to
adults. Information is also available indicating EDTA treatment of
pregnant women is possible without affecting the development of the
fetus. Treatments of EDTA to pregnant women include 75 mg/kg/day
calcium disodium EDTA for 7 days and 1 gram twice a day for 3 days,
under medical supervision. Healthy, normal infants were delivered 4
weeks and 8 days after chelation therapy, respectively.
EPA also believes there would be a very low exposure of infants to
EDTA. First, premature or very young infants ingest only formula or
breast milk. (It is generally recommended that infants not consume
solid food until 4 to 6 months of age). Regulation of infant formulas
is under the purview of the FDA (http://www.fda.gov/fdac/features/596_baby.html
). Calcium disodium EDTA, disodium EDTA, and tetrasodium EDTA
are used as direct food additives (21 CFR 172.120, 172.135, and
178.1010, respectively). However, all manufacturers of infant formula
must begin with safe food ingredients, which are approved either
generally as safe or approved as food additives for use in infant
formula. Neither EDTA nor the salts of EDTA are currently approved by
the FDA for use in infant formula. Therefore, infants consuming only
infant formula or breast
[[Page 11568]]
milk would be exposed to very low amounts of EDTA. Second, even if
young infants were to be fed some solid food, given the characteristics
of EDTA and its salts, residues are not likely to be present at
concentrations for potential sensitivity. Once past this several month
time-period, there is no longer a concern for potential sensitivity to
infants and children. Older infants, like adults, process EDTA through
well understood metabolic pathways.
The comparison of two developmental toxicity studies performed
using disodium EDTA clearly indicates that the presence of trace metals
in the drinking water and diet, particularly zinc, work to prevent
deficiencies. Based on this information concerning both toxicity and
exposure, a safety factor analysis has not been used to assess the risk
of ethylenediaminetetraacetic acid (EDTA) and its various salts. For
the same reasons, the additional tenfold safety factor for the
protection of infants and children is unnecessary.
VIII. Determination of Safety for U.S. Population, and Infants and
Children
Based on the available toxicity data on ethylenediaminetetraacetic
acid (EDTA) and its various salts, with particular emphasis on the
comparison of the findings in the two developmental toxicity studies;
the reviews and evaluations conducted by NTP, NCI, and WHO; the
knowledge that trace metal supplementation occurs via the food and
drinking water consumed by human beings; and considering the estimated
exposures of the wide-spread existing uses of
ethylenediaminetetraacetic acid (EDTA) and its various salts which are
less than levels at which adverse effects were noted, EPA concludes
that there is a reasonable certainty of no harm from aggregate exposure
to residues of ethylenediaminetetraacetic acid (EDTA) and its various
salts. EPA finds that establishing exemptions from the requirement of a
tolerance for ethylenediaminetetraacetic acid (EDTA) and its various
salts with the following limitation ``The concentration of all EDTA
chemicals is not to exceed 5% in the formulated pesticide product''
will be safe for the general population including infants and children.
IX. Other Considerations
A. Endocrine Disruptors
FQPA requires EPA to develop a screening program to determine
whether certain substances, including all pesticide chemicals (both
inert and active ingredients), ``may have an effect in humans that is
similar to an effect produced by a naturally occurring estrogen, or
such other endocrine effect. . .'' EPA has been working with interested
stakeholders to develop a screening and testing program as well as a
priority setting scheme. As the Agency proceeds with implementation of
this program, further testing of products containing
ethylenediaminetetraacetic acid and its various salts for endocrine
effects may be required.
B. Analytical Method(s)
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.
C. Existing Exemptions
There are three existing tolerance exemptions for
ethylenediaminetetraacetic acid, disodium zinc
ethylenediaminetetraacetate dihydride, and ethylenediaminetetraacetic
acid, tetrasodium salt in 40 CFR 180.910. These are the tolerance
exemptions proposed for amendment as a result of this action. There are
four existing tolerance exemptions for the disodium and tetrasodium
EDTA salts in 40 CFR 180.940. These four exemptions are not the subject
of this action.
D. International Tolerances
The Agency is not aware of any country requiring a tolerance or
tolerance exemption for ethylenediamine tetraacetic acid and its
various salts, nor have any CODEX Maximum Residue Levels (MRLs) been
established for any food crops at this time.
X. Conclusions
Accordingly, EPA proposes to establish 16 new and amend three
existing exemptions from the requirement of a tolerance for residues of
various ethylenediaminetetraacetic acid (EDTA) chemicals in or on raw
agricultural commodities when used as inert ingredients in pesticide
formulations applied to growing crops or to raw agricultural
commodities after harvest. The concentration of all EDTA chemicals is
not to exceed 5% in the formulated pesticide product.
XI. Statutory and Executive Order Reviews
This rule proposes to amend three existing and establish 16 new
exemptions from the requirement of a tolerance under section 408(e) of
FFDCA. The Agency is acting on its own initiative. 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 proposed rule has
been exempted from review under Executive Order 12866 due to its lack
of significance, this proposed rule is not subject to Executive Order
13211, Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use (66 FR 28355, May 22, 2001). This proposed
rule does not contain any information collections subject to OMB
approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et
seq., or impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act of 1995
(UMRA) (Public Law 104-4). 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); or OMB review or any
Agency action under Executive Order 13045, entitled Protection of
Children from Environmental Health Risks and Safety Risks (62 FR 19885,
April 23, 1997). 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). The Regulatory Flexibility Act (RFA) (5 U.S.C.
601 et seq.) Generally requires an agency to prepare a regulatory
flexibility analysis of any rule subject to notice and comment
rulemaking requirements under the Administrative Procedure Act or any
other statute unless the agency certifies that the rule will not have a
significant impact on a substantial number of small entities. The
Agency hereby certifies that this proposed action will not have
significant negative economic impact on a substantial number of small
entities. Establishing exemptions from the requirement of a pesticide
tolerance, as is proposed, is in effect the removal of a regulatory
restriction on pesticide residues in food and thus such an action will
not have any negative economic impact on any entities, including small
entities. In addition, the Agency has determined that this action will
not have a substantial direct effect on States, on the relationship
between the national government and the States, or on the distribution
of power and responsibilities among the various
[[Page 11569]]
levels of government, as specified in Executive Order 13132, entitled
Federalism (64 FR 43255, August 10, 1999). Executive Order 13132
requires EPA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' is defined in the Executive Order
to include regulations that have ``substantial direct effects on the
States, on the relationship between the national government and the
States, or on the distribution of power and responsibilities among the
various levels of government.'' This proposed rule directly regulates
growers, food processors, food handlers and food retailers, not States.
This action does not alter the relationships or distribution of power
and responsibilities established by Congress in the preemption
provisions of section 408(n)(4) of FFDCA. For these same reasons, the
Agency has determined that this proposed rule does not have any
``tribal implications'' as described in Executive Order 13175, entitled
Consultation and Coordination with Indian Tribal Governments (65 FR
67249, November 6, 2000). Executive Order 13175, requires EPA to
develop an accountable process to ensure ``meaningful and timely input
by tribal officials in the development of regulatory policies that have
tribal implications.'' ``Policies that have tribal implications'' is
defined in the Executive Order to include regulations that have
``substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and the Indian tribes, or
on the distribution of power and responsibilities between the Federal
Government and Indian tribes.'' This proposed rule will not have
substantial direct effects on tribal governments, on the relationship
between the Federal Government and Indian tribes, or on the
distribution of power and responsibilities between the Federal
Government and Indian tribes, as specified in Executive Order 13175.
Thus, Executive Order 13175 does not apply to this proposed rule.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: February 27, 2006.
Lois Ross,
Director, Registration Division, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
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 180.910, in the table, is amended by removing the entry
for Disodium zinc ethylenediaminetetraacetate dihydride; by revising
the entries for ethylenediaminetetraacetic acid and
ethylenediaminetetraacetic acid (EDTA) tetrasodium salt and adding
alphabetically the remaining entries as set forth below to read as
follows:
Sec. 180.910 Inert ingredients used pre-and post-harvest; exemptions
from the requirement of a tolerance.
------------------------------------------------------------------------
Inert Ingredient Limits Uses
------------------------------------------------------------------------
* * * * * * *
Ethylenediaminetetraacetic acid The concentration Sequestrant
(EDTA) (CAS Reg. No.60-00-4) of all EDTA
chemicals is not
to exceed 5% in
the formulated
pesticide product.
Ethylenediaminetetraaceticacid Do................ Do.
(EDTA) calcium disodium salt
(CAS Reg. No.62-33-9)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) disodiumcopper (II) salt
(CAS Reg. No. 14025-15-1)
Ethylenediaminetetraaceticacid Do................ Do.
(EDTA) disodiumcopper (II)
salt, dihydrate(CAS Reg. No.
61916-40-3)
Ethylenediaminetetraaceticacid Do................ Do.
(EDTA) disodium copper (II)
salt, trihydrate(CAS Reg. No.
73637-19-1)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) disodiummanganese (II)
salt (CAS Reg. No. 15375-84-5)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) disodiummanganese (I)
salt, dihydrate (CAS Reg. No.
73637-20-4)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) disodium salt(CAS Reg.
No. 139-33-3)
Ethylenediaminetetraaceticacid Do................ Do.
(EDTA) disodium salt, dihydrate
(CAS Reg. No. 6381-92-6)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) disodium zincsalt (CAS
Reg. No. 14025-21-9)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) disodium zinc salt,
dihydrate (CAS Reg. No.73513-47-
0)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) monosodiumsalt (CAS Reg.
No. 17421-79-3)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) sodium iron(III) salt
(CAS Reg. No. 15708-41-5)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) sodium salt(CAS Reg. No.
7379-28-4)
Ethylenediaminetetraaceticacid Do................ Do.
(EDTA) tetrapotassiumsalt (CAS
Reg. No. 5964-35-2)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) tetrasodium salt(CAS
Reg. No. 64-02-8)
Ethylenediaminetetraacetic acid Do................ Do.
(EDTA) tetrasodium salt,
tetrahydrate (CAS Reg. No.
13235-36-4)
Ethylenediaminetetraaceticacid Do................ Do.
(EDTA) tetrasodium salt,
trihydrate (CAS Reg. No.67401-
50-7)
Ethylenediaminetetraacetic acid The concentration Sequestrant
(EDTA) tripotassium salt (CAS of all EDTA
Reg. No. 17572-97-3) chemicals is not
to exceed 5% in
the formulated
pesticide product.
* * * * * * *
------------------------------------------------------------------------
[[Page 11570]]
[FR Doc. 06-2106 Filed 3-7-06; 8:45 am]
BILLING CODE 6560-50-S