4512 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

(b) * * * 

(2) * * * 

(ii) The progress which has been 

made toward registration of the 

proposed use, if a repeated specific or 

public health exemption is sought. It 

shall be presumed that if a complete 

application for registration of a use, 

which has been under a specific or 

public health exemption for any 3 

previous years, or any 5 previous years 

if the use is supported for registration by 

the IR-4 program, has not been 

submitted, reasonable progress towards 

registration has not been made. 

■ 7. Section 166.30 is amended by 

revising paragraph (a)(1), removing 

paragraph (b), and redesignating 

paragraph (c) as paragraph (b). 

§ 166.30 Notice of Agency decision. 

(a) * * * 

(1) Incomplete applications. The 

Agency may discontinue the processing 

of any application that does not address 

all of the requirements of § 166.20 until 

such time the additional information is 

submitted by the applicant. 

* * * * * 

■ 8. Section 166.32 is amended by 

revising the introductory text of 

paragraph (b) to read as follows: 

§ 166.32 Reporting and recordkeeping 

requirements for specific, quarantine, and 

public health exemptions. 

* * * * * 

(b) Interim and final reports. A final 

report summarizing the results of 

pesticide use under any specific, 

quarantine, or public health exemption 

must be submitted to the Agency within 

6 months from the expiration of the 

exemption unless otherwise specified 

by the Agency. For quarantine 

exemptions granted for longer than 1 

year, interim reports must be submitted 

annually. When an application for 

renewal of the exemption is submitted 

before the expiration of the exemption 

or before submission of the final report, 

an interim report must be submitted 

with the application. The information in 

interim and final reports shall include 

all of the following: 

* * * * * 

■ 9. Section 166.40 is amended by 

revising paragraph (a), removing the 

period at the end of paragraph (b) and 

adding a semi-colon and the word 

‘‘and’’ at the end of paragraph (b), and 

adding paragraph (c) to read as follows: 

§ 166.40 Authorization. 

* * * * * 

(a) An unpredictable emergency 

condition exists; 

* * * * * 

(c) EPA has provided verbal 

confirmation that, for food uses, a 

tolerance or exemption from the 

requirement of a tolerance can be 

established in a timely manner, 

responsive to the projected timeframe of 

use of the chemical and harvest of the 

commodity, and that, for any use, the 

Agency has no other objection. 

■ 10. Section 166.43 is amended by 

revising paragraphs (a)(1) and (b) to read 

as follows: 

§ 166.43 Notice to EPA and registrants or 

basic manufacturers. 

(a) * * * 

(1) The State or Federal Agency 

issuing the crisis exemption must notify 

the Administrator in advance of 

utilization of the crisis provisions. 

* * * * * 

(b) Contents of notice. Information 

required to be provided in notices shall 

include all of the following: 

(1) The name of the product and 

active ingredient authorized for use, 

along with the common name and CAS 

number if available, including a copy of 

the EPA registered label and use 

directions appropriate to the authorized 

use; 

(2) The site on which the pesticide is 

to be used or is being used; 

(3) The use pattern; 

(4) The date on which the pesticide 

use is to begin and the date when the 

use will end; 

(5) An estimate of the level of residues 

of the pesticide expected to result from 

use under the crisis exemption; 

(6) Earliest anticipated harvest date of 

the treated commodity; 

(7) Description of the emergency 

situation; and 

(8) Any other pertinent information 

available at the time. 

§ 166.47 [Removed] 

■ 11. Section 166.47 is removed. 

■ 12. Section 166.49 is amended by 

revising paragraph (a) to read as follows: 

§ 166.49 Public notice of crisis 

exemptions. 

(a) Periodic notices. At least quarterly, 

the Administrator shall issue a notice in 

the Federal Register announcing 

issuance of crisis exemptions. The 

notice shall contain all of the following: 

(1) The name of the applicant; 

(2) The pesticide authorized for use; 

(3) The crop or site to be treated; and 

(4) The name, address, and telephone 

number of a person in the Agency who 

can provide further information. 

* * * * * 

[FR Doc. 06–743 Filed 1–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0515; FRL–7757–2] 

Sorbitol Octanoate; 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 the biochemical 

sorbitol octanoate on all food 

commodities when applied/used in 

accordance with label directions. AVA 

Chemical Ventures, L. L. C. submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), as 

amended by the Food Quality Protection 

Act of 1996 (FQPA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of sorbitol 

octanoate. 

DATES: This regulation is effective 

January 27, 2006. Objections and 

requests for hearings must be received 

on or before March 28, 2006. 

ADDRESSES: To submit a written 

objection or hearing request follow the 

detailed instructions as provided in 

Unit VIII. of the SUPPLEMENTARY

INFORMATION. EPA has established a 

docket for this action under Docket 

identification (ID) number EPA–HQ–

OPP–2005–0515. All documents in the 

docket are listed on the 

www.regulations.gov website. 

(EDOCKET, EPA’s electronic public 

docket and comment system was 

replaced on November 25, 2005, by an 

enhanced federal-wide electronic docket 

management and comment system 

located at http://www.regulations.gov/. 

Follow the online instructions.) 

Although listed in the index, some 

information is not publicly available, 

i.e., CBI or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either electronically in 

EDOCKET or in hard copy at the Public 

Information and Records Integrity 

Branch (PIRIB), Rm. 119, Crystal Mall 

#2, 1801 S. Bell St., Arlington, VA. This 

docket facility is open from 8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays. The docket 

telephone number is (703) 305–5805. 


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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 4513 

FOR FURTHER INFORMATION CONTACT: 

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511C), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8263; e-mail address: 

greenway.denise@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

•Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Access Electronic Copies 

of this Document and Other Related 

Information? 

In addition to using EDOCKET (http:// 

www.epa.gov/edocket/), you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr/. A 

frequently updated electronic version of 

40 CFR part 180 is available at E-CFR 

Beta Site Two at http:// 

www.gpoaccess.gov/ecfr/. 

II. Background and Statutory Findings 

In the Federal Register of September 

29, 2004 (69 FR 58166) (FRL–7679–1), 

EPA issued a notice pursuant to section 

408(d)(3) of the FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 2E6389) 

by AVA Chemical Ventures, L. L. C., 80 

Rochester Avenue, Suite 214, 

Portsmouth, NH, 03801. The petition 

requested that 40 CFR part 180 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of sorbitol octanoate. This 

notice included a summary of the 

petition prepared by the petitioner AVA 

Chemical Ventures, L. L. C. There were 

no comments received in response to 

the notice of filing. 

Section 408(c)(2)(A)(i) of the 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 the 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), 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), 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 the FFDCA requires that 

the Agency consider ‘‘available 

information concerning the cumulative 

effects of a particular pesticide’s 

residues’’ and ‘‘other substances that 

have a common mechanism of 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 the 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. 

Sorbitol octanoate is a fatty acid ester 

made from sorbitol and caprylic acid. 

Caprylic acid, also known as octanoic 

acid, is a common fatty acid in plants 

that is derived from edible oils or fats. 

It also is produced in small quantities in 

the human body and is marketed as a 

human dietary supplement (Ref. 1). 

Sorbitol, a food grade sweetener with 

about half the sweetness of sucrose, is 

a hexahydric alcohol and occurs 

naturally in fruits such as apples, 

plums, pears, cherries, dates, peaches, 

and apricots (Ref. 2). Both sorbitol and 

octanoic acid are on the Agency’s List 

4 Inerts of Minimal Concern. Sorbitol is 

cleared for food use in unlimited 

quantities as an antidusting agent (40 

CFR 180.910). While sorbitol octanoate 

is the subject of this final rule, the raw 

materials from which it is made are 

common in crops eaten regularly by 

humans and animals. 

Furthermore, sorbitol octanoate is 

chemically and toxicologically similar 

to certain groups of compounds, namely 

certain sorbitan esters and certain 

sucrose octanoate esters that have been 

FDA-approved since 1983 when used as 

direct additives in food, as emulsifiers 

in certain processed foods, and as postharvest protective coatings for certain 

fruits (21 CFR 172.836, 172.838, 

172.840, 172.842 and 172.859). In 1995, 

FDA expanded the range of foods in 

which sucrose octanoate esters (SOEs) 

are permitted (August 29, 1995, 60 FR 

44756). Sorbitol octanoate and SOEs 

both are fatty acid esters, and both are 

made by reacting sugars with octanoic 

acid (i.e., both are non-ionic surfactants 

manufactured by esterifying C8 fatty 

acid with a sugar: sorbitol in the case of 

sorbitol octanoate and sucrose in the 

case of SOEs). Sorbitol octanoate and 

SOEs have similar solubility in water, 

similar degrees of stability, and require 

a similar concentration to achieve 

droplet spread. FDA-approved sorbitan 

esters are different from sorbitol 

octanoate only in that sorbitol has one 

more water molecule than sorbitan. 

Therefore, the toxicological data 

associated with SOEs and sorbitan 

esters can be used to support an 

exemption from the requirement of a 

tolerance for sorbitol octanoate. 

The applicant collected and 

summarized the toxicological data 

associated with the cited FDA food-use 

approvals for SOEs which included 

sorbitan esters (as they are chemically 

similar), and submitted this information 

in support of an earlier tolerance 

exemption request (64 FR 49010, 

September 9, 1999) for SOEs (Ref. 3). In 

turn, the Agency reviewed and accepted 

both the summaries and the underlying 

data in granting the tolerance exemption 

for SOEs (67 FR 60146, September 25, 

2002). Because of the substantial 

similarity between the two active 


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4514 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

ingredients (i.e., sorbitol octanoate and 

SOEs), the Agency allowed the 

applicant to ‘‘bridge’’ to that previouslysubmitted data/information to support 

the tolerance exemption requested for 

sorbitol octanoate. 

Toxicity information/data submitted 

in support of this tolerance exemption 

are referenced below. Toxicity data 

requirements that relate to or aggregate 

with human dietary risk were addressed 

by requests for data waivers, which 

were based on publically available 

information/data that were previously 

submitted by the applicant, and 

reviewed and accepted by the Agency, 

in support of the tolerance exemption 

that the Agency granted for the 

chemically-similar SOEs (Refs. 3, 4, and 

6). In addition, the Agency found 

relevant data from additional public 

sources, including EPA’s National 

Toxicology Program, which contributed 

to the Agency’s review (Ref. 1). All of 

this information/data, which, in 

combination, was equivalent to what 

would normally be provided by 

guideline studies, and therefore would 

likely have been adequate to meet each 

toxicology requirement had they been 

submitted as such pursuant to 40 CFR 

152.90(b)(4), was deemed adequate to 

support the waiver requests. Sorbitan 

esters and sucrose fatty acid esters, 

which are used as food emulsifiers and 

as post-harvest fruit protectants, have 

been found to be of no particular toxic 

concern in studies used to support their 

safety to the FDA. Sorbitol octanoate is 

different from the FDA-approved 

sorbitan esters in that octanoate is the 

sole fatty acid component and sorbitan 

anhydrides are derived from sorbitol by 

removal of one molecule of water. 

Therefore, results from studies on 

sorbitan esters can be used to support 

lack of toxicity concern with sorbitol 

octanoate. Sorbitol octanoate also 

rapidly hydrolyzes to sorbitol and 

octanoic acid, both of which are 

common human dietary components of 

no toxicological concern. Both sorbitol 

and octanoic acid are included in EPA’s 

List 4 inert ingredients, and thus are of 

minimal concern. Sucrose octanoate has 

previously been registered by EPA (EPA 

Reg. No. 70950–2). The rationales for 

waiver requests for all required 

mammalian toxicological studies are 

acceptable. More detailed analyses of 

these data and information can be found 

in specific Agency reviews of the 

studies and technical literature (Refs. 1, 

6, 7, 8 and 9). 

1. Acute oral toxicity waiver (OPPTS 

870.1100) MRID 444158–03, and 

amendment number 1. Acute oral and 

dietary toxicity data, previously 

evaluated in three publications by the 

Food and Agriculture Organization 

(FAO) of the United Nations World 

Health Organization (WHO), were 

submitted in support of this data waiver 

request (Refs. 3 and 4). The data 

contained in these reports demonstrated 

that sorbitan esters and sucrose 

octanoate esters had extremely low oral 

toxicity (in laboratory studies), even at 

concentrations substantially higher than 

are found in human food. 

In studies with rats and humans, it 

was demonstrated that sorbitan esters 

and sucrose octanoate esters were 

rapidly hydrolyzed and absorbed by the 

body. Sorbitol octanoate is different 

from the sorbitan esters approved by 

FDA for direct addition to food for 

human consumption in the degree to 

which water is removed during the 

manufacturing process and the specific 

fatty acid that is used to make the esters. 

Sorbitan is a generic name for 

anhydrides (cyclic ether tetrahydric 

alcohols) derived from sorbitol by 

removal of one molecule of water. 

Octanoic acid is used to make sorbitol 

octanoate, but the sorbitan esters are 

made with mixtures of several longerchain fatty acids. Sorbitan 

monopalmitate in the diet of rats; 

sorbitan monostearate in the diet of rats; 

sorbitan tristearate administered to rats 

by gavage; and sorbitan monopalmitate, 

sorbitan monostearate, and sorbitan 

tristearate in rats (maximum oral dose) 

caused no toxic symptoms/mortality. 

The acute oral LD50s for monoleate and 

sorbitan monolaurate in rats were 39.8 

and 37.5 grams/kilogram (g/kg), 

respectively. An estimate of acceptable 

daily intake in man of 0-25 milligrams/ 

kilogram (mg/kg) was set by the Expert 

Committee on Food Additives. Sorbitol 

octanoate hydrolyzed rapidly to sorbitol 

and octanoic acid. The LD50s for sorbitol 

in mice/rats dosed intravenously or 

orally ranged from 7,100 to 25,700 mg/ 

kg, respectively. The oral LD50s for 

octanoic acid were 1,283 mg/kg (one 

study, male rats) and 10,080 mg/kg 

(another study, male and female rats), 

amounts far greater than humans would 

encounter via the oral exposure route 

from pesticidal use of sorbitol octanoate. 

Sorbitol (21 CFR 184.1835) and 

ocatanoic acid (21 CFR 184.1025) are 

classified as GRAS by the FDA and are 

in EPA’s List 4 - Inerts of Minimal 

Concern. Because sorbitol octanoate is 

chemically similar to SOEs, for which 

an exemption from tolerance already is 

established, and octanoic acid is a 

sorbitol octanoate constituent/degradate 

of no toxicological concern, the 

information/data described above 

support waiver from the data 

requirements for acute oral toxicity 

studies (classification: acceptable; 

Toxicity Category IV for the 

manufacturing-use product and end-use 

product). 

2. Acute dermal toxicity waiver 

(OPPTS 870.1200) MRID 444158–03 and 

amendment number 1. A data waiver 

was granted for this guideline study 

based on the strength of the supporting 

information/data submitted by the 

registrant in connection with the 

tolerance exemption granted for SOEs, 

which as noted above are chemically 

and toxicologically similar to sorbitol 

octanoate. Also, dermal toxicity data on 

the sorbitan esters is relevant to sorbitol 

octanoate. The only difference between 

the sorbitan esters used in cosmetics 

and sorbitol octanoate is in the degree 

to which water is removed during the 

manufacturing process. Sorbitan fatty 

acid esters were generally minimal to 

mild skin irritants in animals and 

humans. In addition, publically 

available sources list the rabbit dermal 

LD50 for octanoic acid (a sorbitol 

octanoate constituent/degradate of no 

toxicological concern) as > 5,000 mg/kg 

(Ref. 1), an amount far greater than 

humans would encounter via the dermal 

exposure route from pesticidal use of 

sorbitol octanoate and which places it in 

the Toxicity Category of no concern (IV) 

(classification: acceptable; Toxicity 

Category IV for the manufacturing-use 

product and end-use product). 

3. Acute inhalation toxicity waiver 

(OPPTS 870.1300) MRID 444158–03 and 

Amendment number 1. A data waiver 

was granted for this guideline study 

based on the strength of the supporting 

information/data submitted by the 

registrant in connection with the 

tolerance exemption granted for SOEs, 

which as noted above are chemically 

and toxicologically similar to sorbitol 

octanoate (Refs. 1,3,4 and 6). No adverse 

effects have been reported by 

researchers working with sorbitol 

octanoate, and the compound is not 

volatile. The sorbitol octanoate 

constituents sorbitol and octanoic acid 

are classified as Generally Recognized 

as Safe (GRAS) by the FDA and are 

among EPA’s List 4 Inerts of Minimal 

Concern. The chemically-similar 

sorbitan fatty acid esters are waxy solids 

or viscous liquids which cannot be 

inhaled (classification: acceptable; 

Toxicity Category IV for the 

manufacturing-use product and end-use 

product). 

4. Hypersensitivity study waiver 

(OPPTS 870.2600) MRID 455973–01. No 

hypersensitivity incidents have been 

reported for laboratory workers 

regularly exposed to sorbitol octanoate 

for up to 7 years. Neither have there 

been reports of hypersensitivity from 


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those working with the chemicallysimilar sucrose octanoate. A waiver for 

conduct of a dermal sensitization study 

for sorbitol octanoate thus can be 

supported. In addition, the registrant is 

obliged under the Federal 

Insecticide,Fungicide, and Rodenticide 

Act (FIFRA) section 6(a)(2) to notify the 

Agency in the event of such incidents 

(classification: acceptable). 

5. Genotoxicity and mutagenicity 

waiver (OPPTS 870.5300, 870.5195) 

MRID 444158–03 and amendment 

number 1. No guideline studies were 

submitted, but it was determined that 

none are required because acceptable 

information/data were submitted from 

the open technical literature to 

scientifically justify a waiver of the data 

requirements for genotoxicity and 

mutagenicity. This information/data 

demonstrate that SOEs and sorbitol 

octanoate (because of their chemical and 

toxicological similarities) are not 

genotoxic and/or mutagenic, nor is the 

active ingredient structurally and/or 

chemically similar to known mutagens 

or known classes of mutagens (Refs. 3, 

4 and 6). In addition, a study reported 

by EPA’s National Toxicology Program 

shows octanoic acid, a sorbitol 

octanoate constituent/degradate of no 

toxicological concern, to be negative for 

genotoxicity/mutagenicity (Ref. 1) 

(classification: acceptable). 

6. Other data requirements waived. 

Immune response and all remaining 

Tier I biochemical toxicology data 

requirements that relate to or aggregate 

with human dietary risk were waived 

(see OPPTS 880.3800 through 870.4200, 

MRID 444158–03 and amendment 

number 1) due to the low toxicity of the 

chemically similar SOEs, as reported in 

the open technical literature (Refs. 3, 4, 

5, 6 and 7). In addition, octanoic acid, 

a sorbitol octanoate constituent/ 

degradate of no toxicological concern, is 

considered a nonteratogenic compound 

even at the very high dose rate of 18.75 

millimoles/kg (Ref. 1). 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of the 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. An Acceptable Daily Intake 

(ADI) of SOEs for humans was estimated 

by FAO/WHO to be up to 16 mg/kg 

body weight/day, which is equivalent to 

1.28 kg of SOEs per day for a 176 lb 

person (Refs. 3, 4, and 6). There are no 

reasonably foreseeable circumstances in 

which the residue levels of SOEs or the 

chemically- and toxicologically-similar 

compound sorbitol octanoate would 

ever approach this amount. Sorbitol 

octanoate hydrolyzes into its 

constituents (sorbitol and octanoic acid) 

shortly after application and then 

biodegrades. In studies with rats and 

humans, it was demonstrated that SOEs 

were rapidly hydrolyzed and absorbed 

by the body (Ref. 6). Because sorbitol 

octanoate is made from sorbitol (present 

in certain fruits) and caprylic acid 

(derived from edible oils and fats), there 

is a great likelihood of exposure in the 

normal human diet to both SOEs 

(derived from sugar and edible tallow or 

edible vegetable oils) and sorbitol 

octanoate, and their components for 

most, if not all, individuals, including 

infants and children. Sorbitol and 

octanoic acid are common components 

of the human diet. Thus, sorbitol 

octanoate may be considered a normal 

part of the human diet. To date, there 

have been no reports of any 

hypersensitivity incidents or reports of 

any known adverse reactions in humans 

resulting from exposure to either SOEs 

(which for years have been FDAapproved food emulsifiers) or the 

chemically-similar sorbitol octanoate. 

Even if there is a significant increase in 

dietary exposure to sorbitol octanoate 

due to its use as a pesticide, the acute 

toxicity information from the National 

Toxicology Program and the information 

submitted by the registrant 

demonstrating extremely low 

mammalian toxicity (Toxicity Category 

IV) for SOEs (which, again, are 

chemically similar to sorbitol octanoate) 

indicate that any possible risk 

associated with acute exposures by the 

oral, dermal and inhalation routes to 

sorbitol octanoate would be low to nonexistent. Further, any increased 

exposure due to the proposed products 

would be negligible because the active 

ingredient sorbitol octanoate will 

rapidly hydrolyze into its constituent 

components (sorbitol and octanoic 

acid), which subsequently will be 

rapidly metabolized by soil bacteria, 

thus limiting the general public’s 

contact with treated plants or food 

products. 

2. Drinking water exposure. No 

drinking water exposure is expected. 

Sorbitol octanoate is not applied 

directly to water, does not persist in the 

environment and biodegrades following 

application/use. Even if sorbitol 

octanoate residues were to enter 

drinking water, we do not expect any 

significant risk since sorbitol octanoate 

will rapidly hydroloyze into its 

consituent components (sorbitol and 

octanoic acid), which then would 

biodegrade prior to consumption by 

microorganisms before the general 

public would contact drinking water 

containing residues of sorbitol 

octanoate. 

B. Other Non-Occupational Exposure 

The potential for non-dietary 

exposure to sorbitol octanoate residues 

for the general population, including 

infants and children, is unlikely because 

the uses are limited to applications to 

horticultural and agricultural crops. The 

sorbitol octanoate constituents sorbitol 

and octanoic acid are normal parts of 

the human diet. Sorbitol octanoate 

toxicity from a dietary exposure 

standpoint has been determined to be 

extremely low. Therefore, while there 

exists a great likelihood of prior 

exposure for most, if not all, individuals 

to both sorbitol octanoate and SOEs, any 

increased non-occupational exposure 

due to the proposed products would be 

negligible because the active ingredient 

sorbitol octanoate will rapidly 

hydrolyze into its constituent 

components (sorbitol and octanoic acid) 

which will be rapidly metabolized by 

soil bacteria, thus limiting the general 

public’s contact with treated plants or 

food products via the dermal or 

inhalation routes. 

V. Cumulative Effects 

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.’’ These 

considerations include the possible 

cumulative effects of such residues on 

infants and children. 

Except through ocular exposure, 

which is only expected in the 

occupational setting and can be 

prevented by the use of protective 

eyewear, neither sorbitol octanoate nor 

SOEs are toxic, and it is not anticipated 

that there would be cumulative effects 

from common mechanisms of toxicity. 

EPA does not have, at this time, 

available data to suggest whether 

sorbitol octanoate has a common 

mechanism of toxicity with other 

substances. Unlike other pesticides for 

which EPA has followed a cumulative 

risk approach based on a common 

mechanism of toxicity, EPA has not 

made a common mechanism of toxicity 


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4516 Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 

finding as to sorbitol octanoate and any 

other substances and sorbitol octanoate 

does not appear to produce a toxic 

metabolite produced by other 

substances. For the purpose of this 

tolerance action, therefore, EPA has not 

assumed that sorbitol octanoate has a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s web site at http:// 

www.epa.gov/pesticides/cumulative. 

VI. Determination of Safety for U.S 

Population, Infants and Children 

1. U.S. population. The Agency has 

determined that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to residues of 

sorbitol octanoate to the U.S. 

population. This includes all 

anticipated dietary exposures and other 

non-occupational exposures for which 

there is reliable information. The 

Agency arrived at this conclusion based 

on the extremely low levels of 

mammalian dietary toxicity associated 

with SOEs and, by extension, sorbitol 

octanoate due to the fact it is nearly 

identical chemically. Accordingly, it is 

unlikely that any toxic effects will result 

from exposure to sorbitol octanoate via 

the oral, dermal or inhalation pathways 

when the registered sorbitol octanoate 

products are used according to proposed 

label directions (Ref. 6). Based upon the 

data submitted in connection with SOEs 

and, by extension, the chemicallysimilar compound sorbitol octanoate, 

the amount of sorbitol octanoate applied 

to food crops is many orders of 

magnitude lower than the 

concentrations of sorbitol octanoate 

needed to cause toxicological effects. 

Because the worst case scenario 

exposure is far below the level of any 

dietary toxicity known for SOEs or 

sorbitol octanoate, or their components 

and degradates, EPA has determined 

that residues will not pose a dietary risk 

under reasonably foreseeable 

circumstances and that granting a 

tolerance exemption is appropriate. 

2. Infants and children. FFDCA 

section 408 provides that EPA shall 

apply an additional tenfold margin of 

exposure for infants and children in the 

case of threshold effects unless the 

Agency determines, based on reliable 

data, that a different margin is safe. 

Margins of exposure are referred to as 

uncertainty or safety factors, and are 

used to account for potential prenatal 

and postnatal toxicity and any lack of 

completeness in the data base. Based on 

all the reliable available information the 

Agency reviewed on SOEs and, by 

extension, sorbitol octanoate due to the 

fact that it is nearly identical 

chemically, the Agency concludes that 

sorbitol octanoate is practically nontoxic to mammals from a dietary 

standpoint, including infants and 

children. Thus, there are no threshold 

effects of concern and an additional 

margin of safety is not necessary to 

protect infants and children. 

VII. Other Considerations 

A. Endocrine Disruptors 

EPA is required under the FFDCA as 

amended by FQPA, to develop a 

screening program to determine whether 

certain substances (including all 

pesticide active and other ingredients) 

‘‘may have an effect in humans that is 

similar to an effect produced by a 

naturally occurring estrogen, or other 

such endocrine effects as the 

Administrator may designate.’’

Following the recommendations of its 

Endocrine Disruptor Screening and 

Testing Advisory Committee (EDSTAC), 

EPA determined that there is no 

scientific basis for including, as part of 

the program, the androgen and thyroid 

hormone systems in addition to the 

estrogen hormone system. EPA also 

adopted EDSTAC’s recommendation 

that the program include evaluations of 

potential effects in wildlife. For 

pesticide chemicals, EPA will use 

FIFRA and, to the extent that effects in 

wildlife may help determine whether a 

substance may have an effect in 

humans, FFDCA authority to require 

wildlife evaluations. As the science 

develops and resources allow, screening 

of additional hormone systems may be 

added to the Endocrine Disruptor 

Screening Program (EDSP). When the 

appropriate screening and/or testing 

protocols being considered under the 

Agency’s EDSP have been developed, 

sorbitol octanoate may be subjected to 

additional screening and/or testing to 

better characterize effects related to 

endocrine disruption. Based on 

available data, no endocrine systemrelated effects have been identified with 

consumption of sorbitol octanoate. To 

date, there is no evidence to suggest that 

sorbitol octanoate affects the immune 

system, functions in a manner similar to 

any known hormone, or that it acts as 

an endocrine disruptor. 

B. Analytical Method(s) 

The Agency is establishing an 

exemption from the requirement of a 

tolerance without any numerical 

limitation for the reasons stated above, 

including low toxicity and low exposure 

from the pesticidal use of sorbitol 

octanoate. For the same reasons, the 

Agency concludes that an analytical 

method is not required for enforcement 

purposes for sorbitol octanoate. 

C. Codex Maximum Residue Level 

There are no CODEX maximum 

residue levels for sorbitol octanoate. 

VIII. Conclusions 

Based on the toxicology information/ 

data submitted and other information 

available to the Agency, there is a 

reasonable certainty that no harm will 

result from aggregate exposure to 

residues of sorbitol octanoate to the U.S. 

population, including infants and 

children, under reasonably foreseeable 

circumstances, when the biochemical 

pesticide is used in accordance with 

product label directions and good 

agricultural practices. This includes all 

anticipated dietary exposures and all 

other non-occupational exposures for 

which there is reliable information. The 

Agency has arrived at this conclusion 

based on the information/data 

submitted (and publically available) 

demonstrating negligible toxicity of the 

chemically-similar SOEs and sorbitan 

esters, and of sorbitol octanoate’s 

constituents (sorbitol and octanoic 

acid). As a result, EPA is establishing an 

exemption from the tolerance 

requirements pursuant to FFDCA 

section 408(c) for residues of sorbitol 

octanoate in or on all food commodities. 

IX. Objections and Hearing Requests 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

Although the procedures in those 

regulations require some modification to 

reflect the amendments made to the 

FFDCA by the FQPA, EPA will continue 

to use those procedures, with 

appropriate adjustments, until the 

necessary modifications can be made. 

The new section 408(g) of the FFDCA 

provides essentially the same process 

for persons to ‘‘object’’ to a regulation 

for an exemption from the requirement 

of a tolerance issued by EPA under new 

section 408(d) of the FFDCA, as was 

provided in the old sections 408 and 

409 of the FFDCA. However, the period 


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Federal Register / Vol. 71, No. 18 / Friday, January 27, 2006 / Rules and Regulations 4517 

for filing objections is now 60 days, 

rather than 30 days. 

A. What Do I Need to Do to File an 

Objection or Request a Hearing? 

You must file your objection or 

request a hearing on this regulation in 

accordance with the instructions 

provided in this unit and in 40 CFR part 

178. To ensure proper receipt by EPA, 

you must identify docket ID number 

EPA–HQ–OPP-2005–0515 in the subject 

line on the first page of your 

submission. All requests must be in 

writing, and must be mailed or 

delivered to the Hearing Clerk on or 

before March 28, 2006. 

1. Filing the request. Your objection 

must specify the specific provisions in 

the regulation that you object to, and the 

grounds for the objections (40 CFR 

178.25). If a hearing is requested, the 

objections must include a statement of 

the factual issues(s) on which a hearing 

is requested, the requestor’s contentions 

on such issues, and a summary of any 

evidence relied upon by the objector (40 

CFR 178.27). Information submitted in 

connection with an objection or hearing 

request may be claimed confidential by 

marking any part or all of that 

information as CBI. Information so 

marked will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. A copy of the 

information that does not contain CBI 

must be submitted for inclusion in the 

public record. Information not marked 

confidential may be disclosed publicly 

by EPA without prior notice. 

Mail your written request to: Office of 

the Hearing Clerk (1900L), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. You may also deliver 

your request to the Office of the Hearing 

Clerk in Suite 350, 1099 14th St., NW., 

Washington, DC 20005. The Office of 

the Hearing Clerk is open from 8 a.m. 

to 4 p.m., Monday through Friday, 

excluding legal holidays. The telephone 

number for the Office of the Hearing 

Clerk is (202) 564–6255. 

2. Copies for the Docket. In addition 

to filing an objection or hearing request 

with the Hearing Clerk as described in 

Unit IX.A.1., you should also send a 

copy of your request to the PIRIB for its 

inclusion in the official record that is 

described in ADDRESSES. Mail your 

copies, identified by docket ID number 

EPA–HQ–OPP–2005–0515, to: Public 

Information and Records Integrity 

Branch, Information Technology and 

Resources Management Division 

(7502C), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. In person or by courier, 

bring a copy to the location of the PIRIB 

described in ADDRESSES. You may also 

send an electronic copy of your request 

via e-mail to: opp-docket@epa.gov. 

Please use an ASCII file format and 

avoid the use of special characters and 

any form of encryption. Copies of 

electronic objections and hearing 

requests will also be accepted on disks 

in WordPerfect 6.1/8.0 or ASCII file 

format. Do not include any CBI in your 

electronic copy. You may also submit an 

electronic copy of your request at many 

Federal Depository Libraries. 

B. When Will the Agency Grant a 

Request for a Hearing? 

A request for a hearing will be granted 

if the Administrator determines that the 

material submitted shows the following: 

There is a genuine and substantial issue 

of fact; there is a reasonable possibility 

that available evidence identified by the 

requestor would, if established resolve 

one or more of such issues in favor of 

the requestor, taking into account 

uncontested claims or facts to the 

contrary; and resolution of the factual 

issues(s) in the manner sought by the 

requestor would be adequate to justify 

the action requested (40 CFR 178.32). 

X. References 

1. USEPA. Brief summary of toxicity 

information to support registration/ 

tolerance exemptions for sucrose 

octanoate. R. S. Jones to D. Greenway; 

August 8, 2002. 

2. Lawson, M.E. 1997. Kirk-Othmer’s 

Encyl Chem Tech. 4th Ed. J.I. 

Kroschwitz (ed). John Wiley & Sons, 

NY. 

3. Barrington, T., and C. L. Hartman. 

Sucrose fatty acid esters- Safety data in 

support of petition proposing a 

temporary (sic) exemption from the 

requirement of a tolerance for use in all 

food commodities (MRID 444158–03); 

October 2, 1997. 

4. Barrington, T. and W. L. Biehn. 

Sucrose fatty acid esters-safety data in 

support of petition proposing an 

exemption from the requirement of a 

tolerance for use in all food 

commodities, Amendment number 1 to 

MRID 444158–03; July 13, 1998. 

5. Barrington, A. Waiver request; July 

12, 2002. 

6. USEPA. Science review in support 

of registration of sucrose octanoate 

esters. R.S. Jones to D. Greenway; 

February 14, 2000. 

7. USEPA. Sucrose octanoate esters; A 

request for concurrence on a decision to 

waive the requirement for 90–day 

feeding study (870.3100) and 

Developmental Toxicity (Teratogenicity 

(870.3700) studies, based on the 

Registrant’s correspondence of July 12, 

2002. D. Greenway to R. S. Jones; 

August 7, 2002. 

8. USEPA. Secondary Review of Data/ 

information submitted to support 

Registration of Sorbitol Octanoate R.D. 

Sjoblad to D. Greenway; December 29, 

2004 

9. USEPA. Endangered Species Risk 

Assessment for Sorbitol Octanoate. R. S. 

Jones to D. Greenway; September 13, 

2005. 

XI. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the tolerance 

requirement under section 408(d) of the 

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 rule has been exempted 

from review under Executive Order 

12866 due to its lack of significance, 

this rule is not subject to Executive 

Order 13211, Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use (66 

FR 28355, May 22, 2001). This 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., or impose 

any enforceable duty or contain any 

unfunded mandate as described under 

Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Public 

Law 104–4). Nor does it require any 

special considerations under Executive 

Order 12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). Since 

tolerances and exemptions that are 

established on the basis of a petition 

under section 408(d) of the 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. In 

addition, the Agency has determined 

that this action will not have a 


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substantial direct effect on States, on the 

relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of the 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitledConsultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

XII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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: January 13, 2006. 

James Jones, 

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 180.1262 is added to 

subpart D to read as follows: 

§ 180.1262 Sorbitol octanoate; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of sorbitol octanoate in or on all food 

commodities when used in accordance 

with label directions. 

[FR Doc. 06–756 Filed 1–26–06; 8:45 am] 

BILLING CODE 6560–50–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 414 

[CMS–1167–F] 

RIN 0938–AN02 

Medicare Program; Payment for 

Respiratory Assist Devices With BiLevel Capability and a Backup Rate 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Final rule. 

SUMMARY: This final rule clarifies that 

respiratory assist devices with bi-level 

capability and a backup rate must be 

paid as capped rental items of durable 

medical equipment (DME) under the 

Medicare program and not paid as items 

requiring frequent and substantial 

servicing (FSS), as defined in section 

1834(a)(3) of the Social Security Act. 

Before 1999, respiratory assist devices 

with bi-level capability (with or without 

a backup rate feature) were referred to 

as ‘‘intermittent assist devices with 

continuous positive airway pressure 

devices’’ under the Medicare program 

and in the Healthcare Common 

Procedure Coding System (HCPCS). 

This final rule responds to public 

comments received on a proposed rule 

published in the Federal Register on 

August 22, 2003, and finalizes the 

policy in that proposed rule. The rule 

will ensure that respiratory assist 

devices are consistently and properly 

paid under Medicare as capped rental 

items. 

DATES: The provisions of this final rule 

are effective on April 1, 2006. 

FOR FURTHER INFORMATION CONTACT: Joel 

Kaiser, (410) 786–4499. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. Legislative Authority for Payment for 

Durable Medical Equipment (DME) 

Section 1834(a) of the Social Security 

Act (the Act) sets forth the payment 

methodology and requirements for 

payment for the purchase or rental of 

new and used durable medical 

equipment (DME) for Medicare 

beneficiaries under Medicare Part B 

(Supplementary Medical Insurance). In 

accordance with section 1834(a) of the 

Act, payment for DME is made on a fee 

schedule basis. Each item of DME that 

is paid under Medicare Part B is 

classified into one of the following 

payment categories: 

• Inexpensive or other routinely 

purchased DME. 

• Items requiring frequent and 

substantial servicing (FSS). 

• Customized items. 

• Oxygen and oxygen equipment. 

• Other covered items (other than 

DME). 

• Other items of DME (capped rental 

(CR) items). 

Each category has its own unique 

payment rules. With the exception of 

customized items, for each item of DME 

that is identified by a code in the 

Healthcare Common Procedure Coding 

System (HCPCS), a fee schedule amount 

is calculated. The Medicare payment 

amount for a customized item of DME 

is based on the Medicare carrier’s 

individual consideration of that item. 

Section 1834(a) of the Act provides 

that Medicare payment for DME is equal 


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