46260 Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 

4. Collection of Information 

This rule calls for no new collection 

of information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). 

5. Federalism 

A rule has implications for federalism 

under Executive Order 13132, 

Federalism, if it has a substantial direct 

effect on State or local governments and 

would either preempt State law or 

impose a substantial direct cost of 

compliance on them. We have analyzed 

this rule under that Order and have 

determined that it does not have 

implications for federalism. 

6. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to contact the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

7. Unfunded Mandates Reform Act 

The Unfunded Mandates Reform Act 

of 1995 (2 U.S.C. 1531–1538) requires 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 or more in any one year. 

Though this rule will not result in such 

expenditure, we do discuss the effects of 

this rule elsewhere in this preamble. 

8. Taking of Private Property 

This rule will not affect a taking of 

private property or otherwise have 

taking implications under Executive 

Order 12630, Governmental Actions and 

Interference with Constitutionally 

Protected Property Rights. 

9. Civil Justice Reform 

This rule meets applicable standards 

in sections 3(a) and 3(b)(2) of Executive 

Order 12988, Civil Justice Reform, to 

minimize litigation, eliminate 

ambiguity, and reduce burden. 

10. Protection of Children 

We have analyzed this rule under 

Executive Order 13045, Protection of 

Children from Environmental Health 

Risks and Safety Risks. This rule is not 

an economically significant rule and 

does not create an environmental risk to 

health or risk to safety that may 

disproportionately affect children. 

11. Indian Tribal Governments 

This rule does not have tribal 

implications under Executive Order 

13175, Consultation and Coordination 

with Indian Tribal Governments, 

because it does not have a substantial 

direct effect on one or more Indian 

tribes, 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. 

12. Energy Effects 

This action is not a ‘‘significant 

energy action’’ under Executive Order 

13211, Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use. 

13. Technical Standards 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. 

14. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guides the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have determined that this action is one 

of a category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves 

establishing a safety zone, requiring a 

permit wherein an analysis of the 

environmental impact of the regulations 

was performed. This rule is 

categorically excluded, under paragraph 

34(h) of Figure 2–1 of the Commandant 

Instruction. An environmental analysis 

checklist supporting this determination 

and a Categorical Exclusion 

Determination are available in the 

docket where indicated under 

ADDRESSES. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR Part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C., 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Pub. L. 107–295, 116 Stat. 2064; Department 

of Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.T08–0410 to read as 

follows: 

§ 165.T08–0410 Safety Zone; Upper 

Mississippi River, Mile 662.8 to 663.9. 

(a) Location. The following area is a 

safety zone: All waters of the Upper 

Mississippi River, mile 662.8 to 663.9, 

extending the entire width of the 

waterway. 

(b) Effective Date. This rule is 

effective and enforceable on August 10, 

2013. 

(c) Periods of Enforcement. This rule 

will be enforced during the following 

time period: From 8:30 p.m. until 10 

p.m. for all waters from mile 662.8 to 

663.9. The Captain of the Port Upper 

Mississippi River will inform the public 

of the enforcement periods via local 

notice to mariners and subsequent 

changes by broadcast notice to mariners. 

(d) Regulations. (1) In accordance 

with the general regulations in § 165.23 

of this part, entry into this zone is 

prohibited unless authorized by the 

Captain of the Port Upper Mississippi 

River or a designated representative. 

(2) Persons or vessels requiring entry 

into or passage through the zone must 

request permission from the Captain of 

the Port Upper Mississippi River or a 

designated representative. The Captain 

of the Port Upper Mississippi River 

representative may be contacted at 314– 

269–2332. 

(3) All persons and vessels shall 

comply with the instructions of the 

Captain of the Port Upper Mississippi 

River or their designated representative. 

Designated Captain of the Port 

representatives include United States 

Coast Guard commissioned, warrant, 

and petty officers. 

Dated: July 10, 2013. 

B.L. Black, 

Captain, U.S. Coast Guard, Captain of the 

Port Upper Mississippi River. 

[FR Doc. 2013–18342 Filed 7–30–13; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2012–0908; FRL–9389–8] 

Sorbitan Monooleate Ethylene Oxide 

Adduct; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 


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SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of sorbitan, mono9-octadecenoate, poly(oxy-1,2- 

ethanediyl) derivs., (Z)- (CAS Reg. No 

9005–65–6) (also known as ‘‘sorbitan 

monooleate ethylene oxide adduct’’ and 

as ‘‘polysorbate 80’’) when used as an 

inert ingredient in antimicrobial 

formulations for use on food-contact 

surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils. 

Exponent, on behalf of Ecolab, Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting the establishment 

of an exemption from the requirement of 

a tolerance. This regulation eliminates 

the need to establish a maximum 

permissible level for residues of sorbitan 

monooleate ethylene oxide adduct. 

DATES: This regulation is effective July 

31, 2013. Objections and requests for 

hearings must be received on or before 

September 30, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2012–0908, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution 

Ave., NW., Washington, DC 20460– 

0001. The Public Reading Room is open 

from 8:30 a.m. to 4:30 p.m., Monday 

through Friday, excluding legal 

holidays. The telephone number for the 

Public Reading Room is (202) 566–1744, 

and the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: Lois 

Rossi, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7090; email address: 

RDFRNotices@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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.ecfr.gov/cgi-bin/text-idx?&c=ecfr&

tpl=/ecfrbrowse/Title40/40tab_02.tpl. 

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–2012–0908 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 September 30, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2012–0908, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on commenting 

or visiting the docket, along with more 

information about dockets generally, is 

available at http://www.epa.gov/ 

dockets. 

II. Petition for Exemption 

In the Federal Register of February 

15, 2013 (78 FR 11129) (FRL–9378–4), 

EPA issued a document pursuant to 

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

announcing the filing of a pesticide 

petition (PP IN–10524) by Exponent, on 

behalf of Ecolab, Inc., 370 Wabasha St., 

St. Paul MN 55102. The petition 

requested that 40 CFR 180.940(a) be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of sorbitan monooleate 

ethylene oxide adduct when used as an 

inert ingredient in antimicrobial 

formulations applied to food-contact 

surfaces in public eating places, dairyprocessing equipment, and foodprocessing equipment and utensils. That 

document referenced a summary of the 

petition prepared by Exponent, the 

petitioner, which is available in the 

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

There were no comments received in 

response to the notice of filing. 

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 nontoxicity; 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 


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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, 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 FFDCA section 

408(c)(2)(A), 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 sorbitan 

monooleate ethylene oxide adduct 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with sorbitan monooleate 

ethylene oxide adduct 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by sorbitan monooleate ethylene oxide 

adduct as well as the no-observedadverse-effect-level (NOAEL) and the 

lowest-observed-adverse-effect-level 

(LOAEL) from the toxicity studies are 

discussed in this unit. 

The acute oral toxicity of sorbitan 

monooleate ethylene oxide adduct is 

low; the LD50 was >25,000 mg/kg in the 

rat and mouse. Also, no systemic or 

adverse effects were observed in rats 

following a single oral dose of 22,000 

mg/kg/day. Sorbitan monooleate 

ethylene oxide adduct did not cause eye 

irritation in rabbits. It was not a dermal 

sensitizer in guinea pigs. Acute dermal 

toxicity was not observed in rabbits 

exposed to sorbitan sesquioleate 

ethoxylate, a substance that is closely 

related to sorbitan monooleate ethylene 

oxide adduct. 

Sorbitan monooleate ethylene oxide 

adduct was administered via the diet to 

rats in a subchronic toxicity study. 

Systemic toxicity was not observed in 

rats following exposure to 2,500 mg/kg/ 

day of sorbitan monooleate ethylene 

oxide adduct in the diet for 13 weeks. 

In developmental and reproduction 

toxicity studies, rats and mice 

administered sorbitan monooleate 

ethylene oxide adduct at doses >10,000 

mg/kg/day exhibited toxicity. These 

doses well exceed the limit dose of 

1,000 mg/kg/day. 

Available mutagenicity studies 

included the rec-assay, reverse mutation 

assay, chromosome aberration test, a 

mouse micronucleus assay, and a 

dominant lethal test. Sorbitan 

monooleate ethylene oxide adduct was 

negative for inducing mutations and 

aberrations in all of the studies. 

Therefore, sorbitan monooleate ethylene 

oxide adduct is considered 

nonmutagenic. 

Evidence of carcinogenicity was not 

observed in mice. In rats, the incidence 

of adrenal medulla malignant and 

benign pheochromocytoma is 4% and 

58%, respectively, in high dose males. 

The historical control ranges for 

malignant and total benign 

pheochromocytoma are 0–20% and 22– 

48%, respectively. The incidence of 

total benign adrenal medulla 

pheochromocytoma (29/50, 58%) was 

marginally increased though not 

significantly in high dose (50,000 ppm) 

males only when compared to control 

male rats (21/50, 42%). Nevertheless, 

the Agency concluded that the concern 

for carcinogenicity is low based on the 

following: 

1. The adrenal medulla 

pheochromocytomas were observed in 

only one sex and species at an 

extremely high dose, 2,500 mg/kg/day, 

which is in excess of 2.5 times the limit 

dose; 

2. The increased incidence was 

observed in benign tumors, 

3. The lack of mutagenicity of sorbitan 

monoleate ethylene oxide adduct; and 

4. General low toxicity of the 

substance. Therefore, a cancer risk 

assessment was not conducted. 

Neurotoxicity parameters were 

evaluated in a reproduction toxicity 

study in rats with sorbitan monooleate 

ethylene oxide adduct. Evidence of 

neurotoxicity was not observed. 

Although no immunotoxicity studies 

were available for review, none of the 

submitted studies indicated any 

evidence of immunotoxicity. 

A metabolism study in rats showed 

that sorbitan monooleate ethylene oxide 

adduct administered orally is 

hydrolyzed, poorly absorbed, and 

excreted mainly in the feces. 

Bioaccumulation was not observed. 

B. Toxicological Points of Departure/ 

Levels of Concern 

The available toxicity studies indicate 

that sorbitan monooleate ethylene oxide 

adduct has very low toxicity. The 

toxicity database is consists of toxicity 

data on subchronic and chronic 

exposures; carcinogenicity, 

developmental, reproduction, 

mutagenicity and metabolism. Although 

a developmental study in rabbits and a 

dermal toxicity study are not available, 

there is no concern for the lack of these 

studies. There is no concern for the lack 

of a developmental study in rabbits 

because fetal susceptibility was not 

observed in the available developmental 

and reproduction studies in rats and 

mice. Also, toxicity was only observed 

at doses (>10,000 mg/kg/day) well above 

the limit dose. 

In regard to the sorbitan monooleate 

ethylene oxide adduct toxicity database, 

the lowest NOAEL (100 mg/kg/day) was 

observed in a developmental study in 

rats where 100 mg/kg/day was the only 

tested dose. However, the results in this 

study were considered unreliable 

because the effects were not 

reproducible in other studies conducted 

with the same species, at higher doses 

and longer exposure. In these remaining 

studies, toxicity was observed only at 

doses >2,500 mg/kg/day, well above the 

limit dose of 1,000 mg/kg/day. 

Therefore, since no endpoint of concern 

was identified for the acute and chronic 

dietary exposure assessment and short 

and intermediate dermal and inhalation 

exposure, a quantitative risk assessment 


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for sorbitan monooleate ethylene oxide 

adduct is not necessary. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to sorbitan monooleate 

ethylene oxide adduct, EPA considered 

exposure under the proposed exemption 

from the requirement of a tolerance (40 

CFR 180.940(a)) and as an inert 

ingredient used in pesticide 

formulations applied to growing crops 

and animals under the existing 

exemptions from the requirement of a 

tolerance given at 40 CFR 180.910 and 

180.930. EPA assessed dietary 

exposures from sorbitan monooleate 

ethylene oxide adduct in food as 

follows: 

Sorbitan monooleate ethylene oxide 

adducts are used as surfactants, related 

adjuvants of surfactants, emulsifiers, 

buffering agents, and corrosion 

inhibitors in a variety of residential 

pesticide products including yard, 

garden, and turf products, as well as in 

agricultural crop products, applied to 

growing crops, raw agricultural 

commodities after harvest, and/or to 

animals. Additionally, they are used 

extensively as emulsifiers, stabilizers 

and thickeners in food, cosmetics, 

personal care and medical products, and 

lubricants. 

For the general population, the 

majority of exposure to sorbitan 

monooleate ethylene oxide adduct 

occurs from the extensive use in 

consumer products and as FDAapproved direct and indirect food 

additives. Under this exemption from 

the requirement of a tolerance, residues 

of this chemical also may be found on 

food-contact surfaces, such as tableware 

and utensils, and in dairies and 

beverage- and food-processing plants. 

Because no hazard endpoint of concern 

was identified for the acute and chronic 

dietary assessment (food and drinking 

water), a quantitative dietary exposure 

risk assessment was not conducted. 

2. Dietary exposure from drinking 

water. Sorbitan monooleate ethylene 

oxide adduct is not expected to be 

present in drinking water based on its 

physical/chemical properties. Further, a 

hazard endpoint of concern was not 

identified for the acute and chronic 

dietary assessment; therefore, a 

quantitative dietary exposure risk 

assessment was not conducted. 

3. 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). In the case of sorbitan 

monooleate ethylene oxide adduct, the 

request is for use as an inert ingredient 

in antimicrobial formulations for use on 

food contact surfaces. Sorbitan 

monooleate ethylene oxide adduct may 

also be used in personal care products 

and in products that are registered for 

specific uses that may result in 

residential exposure. However, based on 

the lack of toxicity, a quantitative 

exposure assessment from ‘‘residential 

exposures’’ was not performed. 

4. 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 sorbitan 

monooleate ethylene oxide adduct to 

share a common mechanism of toxicity 

with any other substances, and sorbitan 

monooleate ethylene oxide adduct does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

sorbitan monooleate ethylene oxide 

adduct 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. 

D. Safety Factor for Infants and 

Children 

1. In general. 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. 

As part of its qualitative assessment, 

the Agency did not use safety factors for 

assessing risk, and no additional safety 

factor is needed for assessing risk to 

infants and children. The toxicity 

database contains several acute and 

subchronic, carcinogenicity, 

development toxicity, reproductive 

toxicity, and mutagenicity studies. The 

available toxicity studies indicate that 

sorbitan monooleate ethylene oxide 

adduct has very low toxicity. The lowest 

NOAEL (100 mg/kg/day) was observed 

in a developmental study where 100 

mg/kg/day was the only tested dose. 

However, in the remaining studies 

where more than one dose was tested, 

toxicity was observed only at doses 

>2,500 mg/kg/day, well above the limit 

dose of 1,000 mg/kg/day. Further, fetal 

toxicity was only observed at doses 

>10,000 mg/kg/day. Although no 

neurotoxicity studies are available for 

sorbitan monooleate ethylene oxide 

adduct, EPA is not concerned for 

neurotoxic effects because neurotoxicity 

was not observed in a developmental 

study in rats where neurotoxic 

parameters were evaluated. Also, 

although no immunotoxicity studies are 

available for sorbitan monooleate 

ethylene oxide adduct, none of the 

submitted studies showed any 

indications of immunotoxicity. Thus, 

there is no residual uncertainty with 

regard to pre- and post-natal toxicity of 

sorbitan monooleate ethylene oxide 

adduct. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic dietary pesticide exposures are 

safe by comparing aggregate exposure 

estimates to the acute PAD (aPAD) and 

chronic PAD (cPAD). For linear cancer 

risks, EPA calculates the lifetime 

probability of acquiring cancer given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the appropriate 

PODs to ensure that an adequate MOE 

exists. 

1. Acute risk. An acute aggregate risk 

assessment takes into account acute 

exposure estimates from dietary 

consumption of food and drinking 

water. No adverse effect resulting from 

a single oral exposure was identified 

and no acute dietary endpoint was 

selected. Therefore, sorbitan monooleate 

ethylene oxide adduct is not expected to 

pose an acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that based on the lack of toxicity of 

sorbitan monooleate ethylene oxide 

adduct and since no chronic endpoint 

was identified, chronic risk is not 

expected. 


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3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). Because no short-term 

adverse effect was identified, sorbitan 

monooleate ethylene oxide adduct is not 

expected to pose a short-term risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Because no intermediate-term adverse 

effect was identified, sorbitan 

monooleate ethylene oxide adduct is not 

expected to pose an intermediate-term 

risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the discussion of 

the potential carcinogenicity of sorbitan 

monooleate ethylene oxide adduct in 

Unit IV.A., sorbitan monooleate 

ethylene oxide adduct is not expected to 

pose a cancer risk. 

6. Determination of safety. Based on 

the lack of concern for hazard posed by 

sorbitan monooleate ethylene oxide 

adduct, EPA concludes that there is a 

reasonable certainty that no harm will 

result to the general population or to 

infants and children from aggregate 

exposure to sorbitan monooleate 

ethylene oxide adduct. 

V. 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 Nation 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 sorbitan monooleate ethylene oxide 

adduct. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.940(a) for sorbitan, 

mono-9-octadecenoate, poly(oxy-1,2- 

ethanediyl) derivs., (Z)- (also known as 

sorbitan monooleate ethylene oxide 

adduct) (CAS Reg. No. 9005–65–6) 

when used as an inert ingredient (in 

antimicrobial formulations) applied to 

food-contact surfaces in public eating 

places, dairy-processing equipment, and 

food-processing equipment and utensils. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of a 

tolerance under FFDCA section 408(d) 

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 FFDCA section 408(d), such as 

the exemption to the requirement of a 

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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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) (15 U.S.C. 272 note). 

VIII. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: July 22, 2013. 

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 § 180.940, in paragraph (a), 

alphabetically add the following inert 

ingredient to the table to read as 

follows: 


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Federal Register / Vol. 78, No. 147 / Wednesday, July 31, 2013 / Rules and Regulations 46265 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 

Pesticide chemical CAS Reg. 

No. Limits 

*****

Sorbitan, mono-9- 

octadecenoate, 

poly(oxy-1,2- 

ethanediyl) derivs., 

(Z)-.

9005–65–6 None. 

*****

* * * * * 

[FR Doc. 2013–18188 Filed 7–30–13; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0917; FRL–9391–2] 

Complex Polymeric Polyhydroxy 

Acids; 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 Complex 

Polymeric Polyhydroxy Acids in or on 

all food commodities. This regulation 

eliminates the need to establish a 

maximum permissible level for residues 

of Complex Polymeric Polyhydroxy 

Acids (CPPA) under FFDCA. 

DATES: This regulation is effective July 

31, 2013. Objections and requests for 

hearings must be received on or before 

September 30, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2009–0917, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Menyon Adams, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8496; email address: 

adams.menyon@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. The following 

list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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.ecfr.gov/cgi-bin/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the OCSPP test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/ocspp 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, 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–2009–0917 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 September 30, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2009–0917, by one of the methods 

provided in 40 CFR 150.17(b). 

II. Background and Statutory Findings 

In the Federal Register of January 13, 

2010 (75 FR 1775) (FRL–8805–6), EPA 

issued a notice pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 9F7645) by James 

R. Yowell of Spring Trading Company 

(the Petitioner), on behalf of Floratine 

Biosciences Inc., 153 N. Main St., Suite 

100, Collierville, TN 38017. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of Complex Polymeric 

Polyhydroxy Acids. That document 

referenced a summary of the petition 

prepared by the Petitioner, which is 

available in the docket, http:// 

www.regulations.gov. No comments 

were received. 

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 

FFDCA section 408(c)(2)(B), in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), which require EPA to give 

special consideration to exposure of 

infants and children to the pesticide 

chemical residue in establishing a 


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