Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6347 

* * * * * 

§ 180.920 [Amended] 

■ 3. Section 180.920 is amended by 

removing from the table the entries for 

‘‘n-Decyl alcohol’’ and ‘‘n-Octyl alcohol’’. 

[FR Doc. 2011–2398 Filed 2–3–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0733; FRL–8860–6] 

(S,S)-Ethylenediamine Disuccinic Acid 

Trisodium Salt; 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 (S,S)- 

ethylenediamine disuccinic acid 

trisodium salt (CAS Reg. No. 178949– 

82–1) when used as an inert ingredient 

(sequestrant or chelating agent) in 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest under EPA 

regulations. Innospec Limited submitted 

a petition to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of (S,S)- 

ethylenediamine disuccinic acid 

trisodium salt. 

DATES: This regulation is effective 

February 4, 2011. Objections and 

requests for hearings must be received 

on or before April 5, 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 section). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0733. 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 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: 

Alganesh Debesai, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8353; e-mail address: 

debesai.alganesh@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. 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a, 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–2010–0733 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 April 5, 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–2010–0733, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(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. Petition for Exemption 

In the Federal Register of September 

23, 2010 (75 FR 57942) (FRL–8845–4), 

EPA issued a notice pursuant to section 

408 of FFDCA, 21 U.S.C. 346a, 

announcing the filing of a pesticide 

petition (PP 0E7753) by Innospec 

Limited, c/o Walter G. Talarek, PC, 1008 

Riva Ridge Drive, Great Falls, VA 

22066–1620. The petition requested that 

40 CFR 180.910 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of (S,S)-ethylenediamine disuccinic acid 

trisodium salt (CAS Reg. No. 178949– 

82–1) when used as an inert ingredient 

as sequestrant or chelating agent in 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest. That notice 

referenced a summary of the petition 


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6348 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

prepared by Innospec Limited, the 

petitioner, which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. For ease 

of reading in this document, (S,S)- 

ethylenediamine disuccinic acid 

trisodium salt is referred to as (S,S)- 

EDDS trisodium salt. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply no toxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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 tolerance is ‘‘safe.’’ 

Section 408(b)(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. Section 

408(b)(2)(C) of FFDCA requires 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. * * *’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food and 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. If 

EPA is able to determine that a finite 

tolerance is not necessary to ensure that 

there is a reasonable certainty that no 

harm will result from aggregate 

exposure to the inert ingredient, an 

exemption from the requirement of a 

tolerance may be established. 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for (S,S)-EDDS 

trisodium salt including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with (S,S)-EDDS trisodium 

salt follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies 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 Agency completed a risk 

assessment on October 28, 2008 for the 

approval of an exemption from the 

requirement of a tolerance under 40 CFR 

180.920 for pre-harvest use for a 

substantially similar chemical, i.e., 

(S,S)-ethylenediamine disuccinic acid, 

(CAS Reg. No. 20846–91–7) which is 

referred to as (S,S)-EDDS. This risk 

assessment as well as data on another 

similar compound, ethylenediamine 

tetraacetic acid (EDTA), was used to 

evaluate the current request for (S,S)- 

EDDS trisodium salt (CAS Reg. No. 

178949–82–1) because it is likely that 

(S,S)-EDDS trisodium salt, EDTA, and 

(S,S)-EDDS readily disassociates in the 

body to their respective salts or acids 

and the active moiety ethylenediamine. 

Therefore, these toxicological data can 

be bridged. 

Briefly, studies show that (S,S)-EDDS 

has low acute and subchronic toxicity, 

is a mild eye irritant, and is not a 

dermal irritant or skin sensitizer. Based 

on the results of submitted mutagenicity 

studies, (S,S)-EDDS is not likely to be 

mutagenic. No carcinogenicity studies 

are available on (S,S)-EDDS, however, 

NTP tested trisodium EDTA in mice and 

rats and it showed no carcinogenic 

potential. Based on its similarity with 

EDTA and lack of mutagenicity, (S,S)- 

EDDS is not likely to be carcinogenic to 

humans at low doses. In addition, 

metabolism studies show that (S,S)- 

EDDS is poorly absorbed but rapidly 

excreted within 72 hours. 

The (S,S)-EDDS studies indicate 

developmental toxicity only at high 

dosage levels that resulted in maternal 

toxicity (limit dose levels). In a 

developmental toxicity study in rats, the 

maternal toxicity low observed adverse 

effect level (LOAEL) is 944.1 

milligrams/kilograms/body weight/day 

(mg/kg bw/day) (16,000 parts per 

million (ppm)) (limit dose) based on 

reductions in body weight, body weight 

gain, feed consumption, and blood 

levels of zinc, iron, and copper, and the 

no observed adverse effect level 

(NOAEL) is 551.1 mg/kg bw/day (8,000 

ppm). The developmental toxicity 

LOAEL of 944.1 was based on an 

increase in fetal death, reduced fetal 

growth, and multiple developmental 

malformations and variations affecting 

almost all major organ systems and 

skeletal structures, and the NOAEL is 

551.1 mg/kg bw/day (8,000 ppm). 

Therefore, the maternal and 

developmental NOAEL are both 551.1 

mg/kg bw/day (8,000 ppm). The results 

of this dietary study indicate qualitative 

evidence of increased susceptibility; 

however, the concern for this increased 

susceptibility is low for the reasons 

discussed in Unit IV.D. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by (S,S)-EDDS as well as 

the NOAEL and the LOAEL from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

for Petition #4E6818 (S,S)- 

ethylenediaminedisuccinic acid (CAS 

Reg. No. 20846–91–7) for tolerance 

exemption under 40 CFR 180.920 under 

docket ID number EPA–HQ–OPP–2008– 

0250. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Due to the low potential hazard of this 

chemical, quantitative dietary or 

occupational and residential exposure 

assessment is not necessary. However, 

EPA conducted quantitative chronic 

dietary assessment using the NOAEL of 

551.0 mg/kg/day based on reductions in 

body weight, body weight gain, feed 

consumption seen at the LOAEL of 944 


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Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6349 

mg/kg/day observed in a developmental 

toxicity study in rats with uncertainty 

factor of 100 (10x for intraspecies 

variability and 10x for interspecies 

extrapolation). The Food Quality 

Protection Act (FQPA) safety factor (SF) 

was reduced to 1X. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses and drinking water. Since 

toxicity effects were seen only at the 

limit dose for (S,S)-EDDS, a quantitative 

exposure assessment for (S,S)-EDDS 

trisodium salt is not needed. Any 

possible dietary exposure to (S,S)-EDDS 

trisodium salt from its use as an inert 

ingredient in pesticide products would 

be through consumption of food to 

which pesticide products containing it 

have been applied, although the rapid 

biodegradation properties will reduce 

the amount of (S,S)-EDDS trisodium salt 

that is available for uptake by plants. 

Run-off into surface water is not 

anticipated due to rapid biodegradation, 

and therefore, contributions of concern 

to drinking water are not expected. 

To further support this conclusion, 

the Agency performed a dietary (food 

and drinking water) exposure 

assessment for (S,S)-EDDS trisodium 

salt using worst case assumptions as 

detailed below. This exposure 

assessment assumed that: 

i. (S,S)-EDDS trisodium salt would be 

used as an inert ingredient in all food 

use pesticide formulations applied to all 

crops. 

ii. One hundred percent of all food 

crops would be treated with pesticides 

containing (S,S)-EDDS trisodium salt. 

iii. (S,S)-EDDS trisodium salt residues 

would be present in all crops at levels 

equal to or exceeding the highest 

established tolerance levels for any 

pesticide active ingredient for the use, 

and 

iv. A conservative default value of 100 

parts per billion (ppb) for the 

concentration of an inert ingredient in 

all sources of drinking water was used. 

This approach is highly conservative as 

it is extremely unlikely that (S,S)-EDDS 

trisodium salt would have such use as 

pesticide product inert ingredients and 

be present in food commodities and 

drinking water at such high levels. 

EPA also considered whether it 

should quantitatively aggregate 

exposure to (S,S)-EDDS trisodium salt 

and EDTA (ethylenediamine tetraacetic 

acid) and its salts and S,Sethylenedamine disuccinic acid (S,SEDDS) in assessing risk. However, 

because these chemicals are chelating 

agents, it is not expected that more than 

one of these chemicals would be present 

in the same pesticide formulation. 

Further, in quantitatively assessing risk, 

EPA has assumed that (S,S)-EDDS 

trisodium salt would be present in all 

foods and at extremely high values. 

Thus, EPA believes that its approach to 

aggregate exposure is conservative and 

health protective. 

2. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

(S,S)-EDDS trisodium salt may be 

used as an inert ingredient in pesticide 

products that are registered for specific 

uses that may result in both outdoor and 

indoor residential exposures. In 

addition, (S,S)-EDDS trisodium salt may 

be used in and around the home. 

Although dermal and inhalation 

exposures are possible from residential 

use of pesticide products containing this 

inert ingredient, negligible inhalation 

and dermal absorption is expected 

based on its low toxicity, poor 

absorption, and rapid biodegradation 

properties of the chemical and therefore, 

an aggregate risk assessment was not 

performed. 

3. 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.’’ 

As explained above, EPA has based its 

assessment of the toxicity of (S,S)-EDDS 

trisodium salt on data on the toxicity of 

EDTA (ethylenediamine tetraacetic acid) 

and its salts and S,S-ethylenedamine 

disuccinic acid (S,S-EDDS). For the 

same reason, EPA believes that 

aggregate exposure to these compounds 

would have cumulative toxic effects. 

EPA’s approach to aggregating 

exposures to these compounds is 

discussed in Unit IV.C.1. 

EPA has not found (S,S)-EDDS 

trisodium salt to share a common 

mechanism of toxicity with any other 

substances, and (S,S)-EDDS trisodium 

salt does not appear to produce a toxic 

metabolite produced by any other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that (S,S)-EDDS trisodium salt 

does not have a common mechanism of 

toxicity with any 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. 

However, these chemicals are 

chelating agents, therefore, it is not 

expected that all of these chemicals 

would be present in the same pesticide 

formulation. A quantitative aggregate 

exposure assessment was not performed 

for this class of chemicals since highly 

conservative dietary exposure 

assessments (food and water) for U.S. 

general population was less than 5% of 

the cPAD. 

D. Safety Factor for Infants and 

Children 

Section 408(b)(2)(C) of FFDCA 

provides that EPA shall apply an 

additional tenfold (10X) 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 on toxicity 

and exposure unless EPA determines, 

based on reliable data, that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

EPA has determined that reliable data 

show the safety of infants and children 

would be adequately protected if the 

FQPA SF were reduced to 1X. That 

decision is based on the following 

findings: 

1. EPA has sufficient data to assess 

the toxicity of (S,S)-EDDS trisodium 

salt. Although the toxicological database 

on (S,S)-EDDS trisodium salt is limited, 

adequate long term studies are available 

on structurally related compounds such 

as (S,S)-EDDS calcium disodium EDTA, 

and trisodium EDTA. Based on the 

structural similarities in these 

compounds, EPA concluded the 

database for (S,S)-EDDS trisodium salt is 

adequate. 

2. EPA has low concern regarding the 

potential developmental effects of (S,S)- 

EDDS trisodium salt. The (S,S)-EDDS 

studies indicate developmental toxicity 

only at high dosage levels that resulted 

in maternal toxicity (limit dose levels). 

In evidence of increased susceptibility; 

however, the concern for this increased 

susceptibility is low because: 

i. Effects were seen only at the limit 

dose and in the presence of maternal 

toxicity. 

ii. There is a well characterized 

NOAEL (551.1 mg/kg/day) protecting 

from these effects. 


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6350 Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 

iii. The presence of zinc, iron and 

copper may have contributed to the 

observed developmental toxicity, since 

other chelating agents (such as EDTA) 

have been shown to impact zinc, iron, 

and copper levels and some of the 

developmental toxicity. 

iv. The results were not reproduced in 

a concurrently conducted gavage study 

in rats at doses up to 1,000 mg/kg/day. 

3. Neurotoxicity studies are not 

available in the database; however, there 

is no evidence of clinical signs of 

neurotoxicity in the available studies. 

Therefore, developmental neurotoxicity 

study is not required. 

4. Immunotoxicity study is not 

available; however, there is no evidence 

of immune system involvement in the 

available studies. 

5. In the absence of actual exposure 

data on (S,S)-EDDS trisodium salt, a 

highly conservative exposure estimate 

was utilized thereby reducing 

uncertainty associated with exposures 

by infants and children to (S,S)-EDDS 

trisodium salt. 

E. Aggregate Risks and Determination of 

Safety 

Considering the low toxicity, poor 

absorption, and rapid biodegradation 

properties of (S,S)-EDDS trisodium salt, 

residues of concern are not anticipated 

from dietary exposures (food and 

drinking water) or from residential 

exposures (inhalation and dermal). 

Utilizing a highly conservative aggregate 

exposure assessment, EPA has 

concluded that aggregate exposures to 

(S,S)-EDDS trisodium salt are more than 

three orders of magnitude less than the 

dose at which no adverse effects were 

seen in the most sensitive animal study 

and are therefore below the level of 

concern. In addition, this highly 

conservative exposure assessment is 

protective of any possible nonoccupational exposures to (S,S)-EDDS 

trisodium salt as it results in exposure 

estimates orders of magnitude greater 

than the high-end exposure estimates 

for residential uses of pesticides 

routinely used by the Office of Pesticide 

Programs. The Agency has not 

identified any concern for 

carcinogenicity related to (S,S)-EDDS 

trisodium salt. 

Taking into consideration all available 

information on (S,S)-EDDS trisodium 

salt, EPA has determined that there is a 

reasonable certainty that no harm to any 

population subgroup, including infants 

and children, will result from aggregate 

exposure to (S,S)-EDDS trisodium salt 

under reasonable foreseeable 

circumstances. Therefore, the 

establishment of an exemption from 

tolerance under 40 CFR 180.910 for 

residues of (S,S)-EDDS trisodium salt 

when used as an inert ingredient in 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest is safe under 

FFDCA section 408. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not needed 

for enforcement purposes since the 

Agency is not establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for (S,S)- 

EDDS trisodium salt nor have any 

CODEX Maximum Residue Levels been 

established for any food crops at this 

time. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 for (S,S)-EDDS 

trisodium salt (CAS Reg. No. 178949– 

82–1) when used as an inert ingredient 

(sequestrant or chelating agent) in 

pesticide formulations applied to 

growing crops or to raw agricultural 

commodities after harvest. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of 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 exemption 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). 

VIII. 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 


jdjones on DSK8KYBLC1PROD with RULES
Federal Register / Vol. 76, No. 24 / Friday, February 4, 2011 / Rules and Regulations 6351 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 24, 2011. 

Lois Rossi, 

Director, Registration Division, 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. In § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredient: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

(S,S)-Ethylenediamine disuccinic acid trisodium salt (CAS Reg. No. 178949– 

82–1).

Sequestrant or chelating agent. 

* * * * * * * 

[FR Doc. 2011–2399 Filed 2–3–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

46 CFR Part 401 

[Docket No. USCG–2010–0517] 

RIN 1625–AB48 

Great Lakes Pilotage: 2011 Annual 

Review and Adjustment 

AGENCY: Coast Guard, DHS. 

ACTION: Final rule. 

SUMMARY: The Coast Guard is increasing 

the rates for pilotage service on the 

Great Lakes to generate sufficient 

revenue to cover allowable expenses, 

target pilot compensation, and return on 

investment. This increase reflects a 

projected August 1, 2011, increase in 

benchmark contractual wages and 

benefits and an adjustment for deflation. 

This rule promotes the Coast Guard’s 

strategic goal of maritime safety. 

DATES: This final rule is effective August 

1, 2011. 

ADDRESSES: Comments and material 

received from the public, as well as 

documents mentioned in this preamble 

as being available in the docket, are part 

of docket USCG–2010–0517 and are 

available for inspection or copying at 

the Docket Management Facility (M–30), 

U.S. Department of Transportation, 

West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. You may also 

find this docket on the Internet by going 

to http://www.regulations.gov, inserting 

USCG–2010–0517 in the ‘‘Keyword’’ 

box, and then clicking ‘‘Search.’’ 

FOR FURTHER INFORMATION CONTACT: If 

you have questions on this rule, call or 

e-mail Mr. Paul Wasserman, Chief, Great 

Lakes Pilotage Division, Commandant 

(CG–5522), Coast Guard; telephone 202– 

372–1535, or e-mail 

Paul.M.Wasserman@uscg.mil. If you 

have questions on viewing the docket, 

call Renee V. Wright, Program Manager, 

Docket Operations, telephone 202–366– 

9826. 

SUPPLEMENTARY INFORMATION: 

Table of Contents for Preamble 

I. Abbreviations 

II. Regulatory History 

III. Basis and Purpose 

IV. Background 

V. Discussion of Comments and Changes 

VI. Discussion of the Final Rule 

A. Summary 

B. Calculating the Rate Adjustment 

VII. Regulatory Analyses 

A. Regulatory Planning and Review 

B. Small Entities 

C. Assistance for Small Entities 

D. Collection of Information 

E. Federalism 

F. Unfunded Mandates Reform Act 

G. Taking of Private Property 

H. Civil Justice Reform 

I. Protection of Children 

J. Indian Tribal Governments 

K. Energy Effects 

L. Technical Standards 

M. Environment 

I. Abbreviations 

AMOU American Maritime Officer Union 

CFR Code of Federal Regulations 

FR Federal Register 

GLPAC Great Lakes Pilotage Advisory 

Committee 

MISLE Marine Information for Safety, and 

Law Enforcement 

NAICS North American Industry 

Classification System 

NPRM Notice of Proposed Rulemaking 

NTTAA National Technology Transfer and 

Advancement Act 

U.S.C. United States Code 

II. Regulatory History 

On August 19, 2010, we published a 

notice of proposed rulemaking (NPRM) 

entitled ‘‘Great Lakes Pilotage Rates: 

2011 Annual Review and Adjustment’’ 

in the Federal Register (75 FR 51191). 

We received three comments on the 

proposed rule. No public meeting was 

requested and none was held. 

III. Basis and Purpose 

The basis of this rulemaking is the 

Great Lakes Pilotage Act of 1960 (‘‘the 

Act’’) (46 U.S.C. chapter 93), which 

requires vessels engaged in foreign trade 

to use U.S. registered pilots while 

transiting the St. Lawrence Seaway and 

the Great Lakes system. The Act also 

requires the Secretary of Homeland 

Security to ‘‘prescribe by regulation rates 

and charges for pilotage services, giving 

consideration to the public interest and 

the costs of providing the services.’’ 46 

U.S.C. 9303(f). The Secretary’s duties 

and authority under the Act have been 

delegated to the Coast Guard, and Coast 

Guard regulations implementing the Act 

appear in parts 401 through 404 of Title 

46, Code of Federal Regulations (CFR). 

The Act requires annual pilotage rate 

reviews to be completed by March 1 of 

each year, with a ‘‘full ratemaking’’ to 

establish new base rates at least once 

every five years. The purpose of this 

rulemaking is to comply with 46 U.S.C. 

9303(f) by applying the ratemaking 

methodology described in Appendix C 

to 46 CFR part 404, which will satisfy 

the requirement for the annual pilotage 

rate review for 2011. 

IV. Background 

The U.S. waters of the Great Lakes 

and the St. Lawrence Seaway are 

divided into three pilotage districts. 

Pilotage in each district is provided by 

an association certified by the Coast 

Guard Director of Great Lakes Pilotage 

to operate a pilotage pool. It is 


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