17556 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Rules and Regulations 

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. 

* * * * * 

(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. 

* * * * * 

(20) Fugitive emissions means those 

emissions which could not reasonably 

pass through a stack, chimney, vent, or 

other functionally equivalent opening. 

* * * * * 

(41) * * * 

(ii) * * * 

(b) Shall include fugitive emissions to 

the extent quantifiable, and emissions 

associated with startups, shutdowns, 

and malfunctions; and 

* * * * * 

(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. 

* * * * * 

(48) * * * 

(i) * * * 

(a) The average rate shall include 

fugitive emissions to the extent 

quantifiable, and emissions associated 

with startups, shutdowns, and 

malfunctions. 

* * * * * 

(ii) * * * 

(a) The average rate shall include 

fugitive emissions to the extent 

quantifiable, and emissions associated 

with startups, shutdowns, and 

malfunctions. 

* * * * * 

(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 

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. 

* * * * * 

(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 

* * * * * 

(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. 

* * * * * 

(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. 

* * * * * 

[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 

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 

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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). 

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: 

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 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 20460–0001. 

• 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 

Mu ̈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 

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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. 

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 

(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 

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 

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 

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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17560 Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Rules and Regulations 

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. 

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 http:// 

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: 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, 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 http:// 

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 

WReier-Aviles on DSKGBLS3C1PROD with RULES

Federal Register / Vol. 76, No. 61 / Wednesday, March 30, 2011 / Rules and Regulations 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] 

■ 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 

AGENCY: Coast Guard, DHS. 

ACTION: Direct final rule; request for 

comments. 

SUMMARY: 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 http:// 

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– 

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