43350 Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Proposed Rules 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R05–OAR–2013–0214; FRL–9914–25– 

Region 5] 

Approval and Promulgation of Air 

Quality Implementation Plans; Indiana; 

Solvent Degreasing Operations Rule 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve a 

request submitted by the Indiana 

Department of Environmental 

Management (IDEM) on March 14, 2013, 

to revise the Indiana state 

implementation plan (SIP) solvent 

degreasing operation rule. The state’s 

submission seeks to extend vapor 

pressure limitations (previously 

applying to four counties) state-wide, 

add certain exemptions and streamline 

the rule by repealing and consolidating 

certain provisions. There is also a 

revised definition for ‘‘cold cleaner 

degreaser.’’ 

DATES: Comments must be received on 

or before August 25, 2014. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2013–0214 by one of the following 

methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: blakley.pamela@epa.gov. 

3. Fax: (312) 692–2450. 

4. Mail: Pamela Blakley, Chief, 

Control Strategies Section (AR–18J), 

U.S. Environmental Protection Agency, 

77 West Jackson Boulevard, Chicago, 

Illinois 60604. 

5. Hand Delivery: Pamela Blakley, 

Chief, Control Strategies Section (AR– 

18J), U.S. Environmental Protection 

Agency, 77 West Jackson Boulevard, 

Chicago, Illinois 60604. Such deliveries 

are only accepted during the Regional 

Office normal hours of operation, and 

special arrangements should be made 

for deliveries of boxed information. The 

Regional Office official hours of 

business are Monday through Friday, 

8:30 a.m. to 4:30 p.m., excluding 

Federal holidays. 

Please see the direct final rule which 

is located in the Rules section of this 

Federal Register for detailed 

instructions on how to submit 

comments. 

FOR FURTHER INFORMATION CONTACT: 

Charles Hatten, Environmental 

Engineer, Control Strategies Section, Air 

Programs Branch (AR–18J), 

Environmental Protection Agency, 

Region 5, 77 West Jackson Boulevard, 

Chicago, Illinois 60604, (312) 886–6031, 

hatten.charles@epa.gov. 

SUPPLEMENTARY INFORMATION: In the 

Final Rules section of this Federal 

Register, EPA is approving the State’s 

SIP submittal as a direct final rule 

without prior proposal because the 

Agency views this as a noncontroversial 

submittal and anticipates no adverse 

comments. A detailed rationale for the 

approval is set forth in the direct final 

rule. If no adverse comments are 

received in response to this rule, no 

further activity is contemplated. If EPA 

receives adverse comments, the direct 

final rule will be withdrawn and all 

public comments received will be 

addressed in a subsequent final rule 

based on this proposed rule. EPA will 

not institute a second comment period. 

Any parties interested in commenting 

on this action should do so at this time. 

Please note that if EPA receives adverse 

comment on an amendment, paragraph, 

or section of this rule, and if that 

provision may be severed from the 

remainder of the rule, EPA may adopt 

as final those provisions of the rule that 

are not the subject of an adverse 

comment. For additional information, 

see the direct final rule which is located 

in the Rules section of this Federal 

Register. 

Dated: July 14, 2014. 

Susan Hedman, 

Regional Administrator, Region 5. 

[FR Doc. 2014–17475 Filed 7–24–14; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2013–0821; FRL–9910–53] 

Fragrance Components; Proposed 

Exemption From the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: This document proposes to 

establishes an exemption from the 

requirement of a tolerance for residues 

of various fragrance component 

substances (when used as inert 

ingredients) in antimicrobial pesticide 

formulations for use on food contact 

surfaces in public eating places, dairy 

processing equipment, and food 

processing equipment and utensils. 

DATES: Comments must be received on 

or before September 23, 2014. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2013–0821, 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 

Confidential Business Information (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. 

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: 

rossi.lois@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. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

www.regulations.gov or email. Clearly 

mark the part or all of the information 

that you claim to be CBI. For CBI 

information in a disk or CD–ROM that 

you mail to EPA, mark the outside of the 


emcdonald on DSK67QTVN1PROD with PROPOSALS
Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Proposed Rules 43351 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When submitting comments, remember 

to: 

i. Identify the document by docket ID 

number and other identifying 

information (subject heading, Federal 

Register date and page number). 

ii. Follow directions. The Agency may 

ask you to respond to specific questions 

or organize comments by referencing a 

Code of Federal Regulations (CFR) part 

or section number. 

iii. Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes. 

iv. Describe any assumptions and 

provide any technical information and/ 

or data that you used. 

v. If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced. 

vi. Provide specific examples to 

illustrate your concerns and suggest 

alternatives. 

vii. Explain your views as clearly as 

possible, avoiding the use of profanity 

or personal threats. 

viii. Make sure to submit your 

comments by the comment period 

deadline identified. 

II. This Proposal 

EPA on its own initiative, under 

FFDCA section 408(e), 21 U.S.C. 

346a(e), is proposing to establish an 

exemption from the requirement of a 

tolerance for residues of acetaldehyde 

(CAS Reg. No. 75–07–0), acetic acid 

(CAS Reg. No. 64–19–7), allyl 

cyclohexyl propionate (CAS Reg. No. 

2705–87–5), butryic acid (CAS Reg. No. 

107–92–6), butyl alcohol (CAS Reg. No. 

71–36–3), citral (CAS Reg. No. 5392–40– 

5), citronellol (CAS Reg. No. 106–22–9), 

citronellyl acetate (CAS Reg. No. 150– 

84–5), b-damascone, (Z)- (CAS Reg. No. 

23726–92–3), decanal (CAS Reg. No. 

112–31–2), (E)-4-decenal (CAS Reg. No. 

65405–70–1), decanoic acid (CAS Reg. 

No. 334–48–5), 1-decanol (CAS Reg. No. 

112–30–1), 2,6-dimethyl-5-heptanal 

(CAS Reg. No. 106–72–9), 2-dodecanol, 

(2E)- (CAS Reg. No. 20407–84–5), dlimonene (CAS Reg. No. 5989–27–5), 

ethyl 2-methylbutyrate (CAS Reg. No. 

452–79–1), (E)–geraniol (CAS Reg. No. 

106–24–1), (E)-geraniol acetate (CAS 

Reg. No. 105–87–3), heptanal (CAS Reg. 

No. 111–71–7), heptanoic acid (CAS 

Reg. No. 111–14–8), heptyl alcohol 

(CAS Reg. No. 111–70–6), hexanal (CAS 

Reg. No. 66–25–1), hexanoic acid (CAS 

Reg. No. 142–62–1), (Z)-3-hexenol (CAS 

Reg. No. 928–96–1), (Z)-3-hexenol 

acetate (CAS Reg. No. 3681–71–8), hexyl 

acetate (CAS Reg. No. 142–92–7), hexyl 

alcohol (CAS Reg. No. 111–27–3), lauric 

acid (CAS Reg. No. 143–07–7), lauric 

aldehyde (CAS Reg. No. 112–54–9), 

lauryl alcohol (CAS Reg. No. 112–53–8), 

methyl-a-ionone (CAS Reg. No. 127–42– 

4), 3-methyl-2-butenyl acetate (CAS Reg. 

No. 1191–16–8), 2-methylundecanal 

(CAS Reg. No. 110–41–8), 

myristaldehyde (CAS Reg. No. 124–25– 

4), myristic acid (CAS Reg. No. 544–63– 

8), neryl acetate (CAS Reg. No. 141–12– 

8), n-hexanol (CAS Reg. No. 111–27–3), 

nonanal (CAS Reg. No. 124–19–6), 

nonanoic acid (CAS Reg. No. 112–05–0), 

nonyl alcohol (CAS Reg. No. 143–08–8), 

octanal (CAS Reg. No. 124–13–0), 

octanoic acid (CAS Reg. No. 124–07–2), 

1–octanol (CAS Reg. No. 111–87–5), 

palmitic acid (CAS Reg. No. 57–10–3), 

propionic acid (CAS Reg. No. 79–09–4), 

stearic acid (CAS Reg. No. 57–11–4), 2- 

tridecanal (CAS Reg. No. 7774–82–5), 

3,5,5-trimethylhexanal (CAS Reg. No. 

5435–64–3), undecanal (CAS Reg. No. 

112–44–7), undecyl alcohol (CAS Reg. 

No. 112–42–5), valeraldehyde (CAS Reg. 

No. 110–62–3), and valeric acid (CAS 

Reg. No. 109–52–4) when used as 

fragrance components (i.e., inert 

ingredients) in antimicrobial pesticide 

formulations for use on food contact 

surfaces in public eating places, dairy 

processing equipment, and food 

processing equipment and utensils at 

end–use concentrations not to exceed 

100 parts per million (ppm). 

III. Aggregate Risk Assessment and 

Determination of Safety 

Section 408(b)(2)(A)(i) of FFDCA 

allows EPA to establish a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

Section 408(b)(2)(A)(ii) of FFDCA 

defines ‘‘safe’’ to mean that ‘‘there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

408(b)(2)(C) of FFDCA requires EPA to 

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue. . . .’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of FFDCA section 408 and 

a complete description of the risk 

assessment process, see http://

www.epa.gov/fedrgstr/EPA-PEST/1997/

November/Day-26/p30948.htm. 

Consistent with FFDCA section 

408(b)(2)(D), 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, 

consistent with FFDCA section 

408(b)(2), for an exemption from 

tolerance for residues of fragrance 

components listed in Unit II. used as 

inert ingredients in antimicrobial 

pesticide formulations for use on food 

contact surfaces in public eating places, 

dairy processing equipment, and food 

processing equipment and utensils at 

end-use concentrations not to exceed 

100 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing the exemptions from 

tolerance for the fragrance components 

listed in Unit II. follows: 

A. Toxicological Profile 

In the case of the fragrance 

components listed in Unit II. above, 

each of these substances has been 

approved for use as a synthetic flavoring 

substance in food under 21 CFR 172.515 

based on a substance-specific evaluation 

conducted by the U.S. Food and Drug 

Administration (FDA). Additionally, the 

fragrance components listed in Unit II. 

above have been evaluated and 

approved for use as food flavoring 

agents by the Joint Food and 

Agricultural Organization of the United 

Nations/World Health Organization 

Expert Committee on Food Additives 

(JECFA) and the European Food Safety 

Agency (EFSA) as part of their 

assessment of more than 2,800 food 

flavoring substances. The EFSA and 

JECFA food flavoring substance were 

conducted under an approach titled the 

Threshold of Toxicological Concern 

(TTC). Under this approach, generic 

human exposure threshold values for 

both non-cancer and cancer endpoints 

are set at a level below which there 

would be no appreciable risk to human 

health. These generic values allow for 

the safety assessment of substances even 


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43352 Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Proposed Rules 

in the absence of substance-specific 

hazard data. 

The derivation of TTC human 

exposure threshold values for noncancer endpoints is based on an 

extensive reference database compiled 

by Munro, (Ref. 1) which included data 

on chronic, subchronic, reproductive 

and developmental toxicity studies 

primarily derived from the reports of the 

US National Toxicology Program (NTP), 

the toxicological monographs of JECFA, 

the EPA Integrated Risk Information 

System (IRIS), and the Developmental 

and Reproductive Toxicology (DART) 

database compiled by the US National 

Library of Medicine. These sources were 

considered to contain well-validated 

toxicological data for well-defined 

chemical structures, covering pesticides, 

food additives, industrial and other 

types of chemicals. Only studies using 

the oral route of administration (gavage, 

diet, drinking water, or capsule) were 

included. In all, the reference database 

contained 2941 no-observed-adverseeffect levels (NOAELs) from studies 

conducted on 613 substances, and from 

these the most conservative (lowest) 

NOAEL for each substance was entered 

on the published database. The NOAELs 

in the reference database were those 

selected by the original authors of each 

study, apart from the studies in the IRIS 

database, for which the NOAELs were 

selected by the EPA. Munro commented 

that some authors were highly 

conservative in their selection of a 

NOAEL, but such NOAELs were still 

used for the database to maintain a 

conservative approach. Munro also 

stated that, in the calculation of the TTC 

values, NOAELs from subchronic 

studies were divided by a factor of 3 to 

approximate the NOAELs that are likely 

to be derived from a chronic study. 

The chemicals in the Munro database 

were divided into three structural 

classes, based on a ‘‘decision tree’’ 

developed earlier by Cramer et al. (Ref. 

2) Cramer Class I are chemicals of 

simple structure, with efficient modes of 

metabolism, suggesting low oral 

toxicity; Cramer Class III are chemicals 

with structures suggesting significant 

toxicity or which did not permit any 

strong initial presumption of safety, and 

Cramer Class II are chemicals with 

structures that were less innocuous than 

Cramer Class I but without features 

suggesting significant toxicity. Human 

exposure threshold values were derived 

by taking the lower 5th percentile value 

of the distribution of NOAELs for the 

substances in each of the three Cramer 

structural classes, multiplying by 60 to 

convert the values expressed as 

milligrams/kilograms (mg/kg) of body 

weight (bw) per day into mg/person per 

day, and then dividing by a factor of 100 

to ensure a margin of safety. 

For substances without structural 

alerts for cancer, the TTC human 

exposure values for non-cancer risks are 

considered protective of any potential 

cancer risk. For substances with a 

structural alert for cancer, a separate 

TTC value has been derived. Originally, 

FDA developed human exposure 

threshold values to protect against all 

chronic risks, including the endpoint of 

cancer, without regard to whether the 

substance had a structural alert for 

carcinogenicity (Ref. 3, 4, 5). FDA 

derived these threshold values using 

mathematical modeling of risks from 

animal bioassay data on over 500 known 

genotoxic and non-genotoxic 

carcinogens, based on their carcinogenic 

potency. In 1995, FDA incorporated the 

threshold value in its threshold of 

regulation (TOR) policy for substances 

present in food contact materials. (Ref 

6). Under the TOR, substances used in 

food contact materials that are present 

in the diet at concentrations below the 

threshold level are exempted from 

regulation as food additives. 

Subsequently, FDA modified this 

approach by adopting lower threshold 

values for substances with a structural 

alert for carcinogenicity. Kroes et al. 

(Ref. 7) This FDA approach as to 

substances with structural alerts for 

carcinogenicity was further refined and 

adopted by EFSA and JEFCA for use in 

the TTC approach. 

The TTC approach has been 

incorporated in the evaluations made by 

JECFA and EFSA in which the 

organizations both concluded that the 

each of the substances listed in Unit II. 

were safe for use as flavoring agents in 

foods. Under 21 CFR 170.39 Threshold 

of regulation for substances used in 

food-contact articles, FDA has issued 

exemptions from regulation as food 

additives for a number of substances 

based on human exposure threshold 

values. 

B. Toxicological Points of Departure/

Levels of Concern 

The human exposure threshold value 

for threshold (i.e., noncancer) risks is 

based upon Cramer structural class. In 

the case of the fragrance components 

listed in Unit II., all of the substances 

are included in the Cramer Class I 

category, which is defined as chemicals 

of simple structure and efficient modes 

of metabolism, suggesting low oral 

toxicity. An EFSA Scientific Committee 

critical evaluation of the human 

threshold values for threshold risks 

concluded that ‘‘the use of the 5th 

percentile No-observed-adverse-effectlevel (NOAEL) and an uncertainty factor 

of 100 to derive the TTC value gives a 

very low probability (somewhere 

between 0–5%) of any appreciable noncancer risk to human health from 

exposures to substances below the 

Cramer Class I TTC value of 30 mg/kg/ 

day’’ (Ref. 8) 

Use of TTC values for risk assessment 

of the fragrance components listed in 

Unit II. is a more conservative 

alternative to the chemical-specific 

Population Adjusted Dose (PAD) or 

Reference Dose (RfD) approach typically 

used in Agency risk assessments. For 

example, in the case of substances 

having chemical structures described by 

Cramer Class I for which chemicalspecific risk assessments have been 

performed, these substances have PAD/ 

RfD values which are often orders of 

magnitude greater than the 

corresponding TTC values (Ref 9). A 

summary of the safe exposure levels 

corresponding to each of the exposure 

scenarios considered the aggregate 

exposure assessment of the fragrance 

components listed in Unit II. is given 

below: 

1. Acute dietary (all populations). 

There were no effects that could be 

attributed to a single dose in the 

database. Therefore, a quantitative acute 

dietary assessment is not necessary. 

2. Chronic dietary (all populations). 

Concerns for chronic dietary exposures 

exceeding the TTC value of 30 mg/kg/

day. 

3. Incidental oral short-term (1 to 30 

days). Concerns for incidental oral 

short-term exposures exceeding the TTC 

value of 30 mg/kg/day. 

4. Dermal short-term (1 to 30 days) 

and intermediate-term (1 to 6 months). 

Concern for dermal exposures exceeding 

the TTC value of 30 mg/kg/day based on 

oral toxicity data and conservative 

assumption of 100% dermal absorption. 

5. Inhalation short-term (1 to 30 days) 

and intermediate-term (1 to 6 months). 

Concern for inhalation exposures 

exceeding the TTC value of 30 mg/kg/

day based on oral toxicity data. Based 

on subchronic inhalation data for a 

number of fragrance substances, 

including some of fragrance components 

listed in Unit II., in which no adverse 

effects were noted at exposure levels up 

to 1% of ambient air (Ref. 10), it is 

reasonable to assume that in the case of 

the fragrance components listed in Unit 

II. inhalation toxicity would not be 

observed at doses below which oral 

toxicity is observed. 

6. Cancer (Oral, dermal, inhalation). 

The Agency used a qualitative structure 

activity relationship (SAR) database, 

DEREK11, to determine if there were 

structural alerts for potential 

genotoxicity/carcinogenicity for any of 


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the fragrance components. No structural 

alerts for genotoxicity/carcinogenicity 

relevant to human exposure to these 

substances as flavoring agents/fragrance 

components were identified, therefore 

the use of the TTC human exposure 

threshold for non-threshold risks for 

these fragrance components is not 

applicable. In these circumstances, 

assessment under the TTC value for 

non-cancer risks is protective for all 

risks, including carcinogenicity. 

The risk assessment and use of human 

threshold values for evaluation of food 

flavoring agents by JECFA and EFSA has 

focused on oral toxicity and dietary 

exposure to substances via food and 

feed. However, the applicability of the 

TTC approach to substance exposure by 

routes other than the oral route has been 

considered by the ESFA Scientific 

Committee. The Scientific Committee 

determined that when several routes of 

exposure are to be taken into account 

they should be reflected in the exposure 

assessment used in the application of 

the TTC approach and that ‘‘the 

application of the TTC approach to 

routes of exposure other than oral can 

be done via route-to-route extrapolation, 

as is often done in conventional risk 

assessment in cases where only oral 

toxicity data are available.’’ 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to the fragrance components 

listed in Unit II., EPA considered 

exposure under the proposed tolerance 

exemptions at a concentration not to 

exceed 100 ppm for each of the 

fragrance components listed in Unit II. 

as well as any other sources of dietary 

exposure. The use limitation of 100 ppm 

was incorporated by the Agency to 

reflect maximum concentrations of 

these fragrance components in 

antimicrobial pesticide formulations as 

well as to ensure that exposures to these 

fragrance components will be below 

levels of concern. In conducting the 

dietary exposure assessment for the 

fragrance components listed in Unit II., 

EPA considered dietary exposure from 

potential residues in or on food 

resulting from the use as inert 

ingredients in antimicrobial pesticide 

product formulations from treated food 

contact surfaces; and from food that 

contains the fragrance components as 

flavoring agents. As to the residue levels 

in or food resulting from the inert 

ingredient uses, in the absence of actual 

dietary exposure data resulting from this 

use, the EPA has utilized a conservative, 

health-protective method of estimating 

dietary intake that is based upon 

conservative assumptions related to the 

amount of residues that can be 

transferred to foods as a result of the 

proposed use of the fragrance 

components in food contact sanitizing 

antimicrobial pesticide products. This 

same methodology has been utilized by 

EPA in estimating dietary exposures to 

antimicrobial pesticides used in foodhandling settings. A complete 

description of the approach used to 

assess dietary exposures resulting from 

food contact sanitizing solution uses of 

the fragrance components can be found 

at http://www.regulations.gov in 

document; ‘‘Various Fragrance 

Components: Human Health Risk 

Assessment and Ecological Effects 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations,’’ 

pp. 5–8 in docket ID number EPA–HQ– 

OPP–2013–0821. 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1-day or single 

exposure. No such effects were 

identified in the toxicity database for 

the fragrance components listed in Unit 

II., therefore a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, the Agency believes the 

assumptions used to estimate chronic 

dietary exposures lead to an extremely 

conservative assessment of chronic 

dietary risk due to a series of 

compounded conservatisms. First, when 

a surface is treated with a disinfectant, 

a quantity of the disinfectant remains on 

the surface (residual solution). In the 

absence of any other data, EPA has used 

an estimated worst-case concentration 

of 1 mg of solution per square 

centimeter (cm) of treated surface area 

for this quantity. Second, the 

conservatism of this methodology is 

compounded by EPA’s decision to 

assume a worst case scenario that all 

food that an individual consumes will 

come into contact with 4,000 cm 2 of 

sanitized non-porous food-contact 

surfaces. This contact area represents all 

the surface area from silverware, china, 

and glass used by a person who 

regularly eats three meals per day at an 

institutional or public facility. The 

surface area of counter tops that comes 

in contact with food is expected to be 

smaller than the surface area for food 

utensils. As a conservative estimate, 

EPA assumed that 2,000 cm 2 of treated 

counter top surface area, comes into 

contact with an individual’s food per 

day. Third, EPA assumes that 100% of 

the material present on food contact 

surfaces will migrate to food (Ref 11). 

iii. Cancer. Based on the data 

summarized in Unit III. A., EPA has 

concluded that the fragrance 

components listed in Unit II. are not 

expected to be carcinogenic to humans. 

Therefore, a dietary exposure 

assessment for the purpose of assessing 

cancer risk is unnecessary. 

2. Dietary exposure from drinking 

water. The proposed use of the fragrance 

components listed in Unit II. in 

antimicrobial pesticide products has 

only a limited opportunity to result in 

contamination of drinking water 

because these types of products are used 

inside of structures. There is the 

possibility of exposure to drinking water 

sources via down-the-drain releases and 

discharges to waste water treatment 

plants; however, based on the extremely 

low concentrations of the fragrance 

components in pesticide formulations, 

combined with the biodegradability of 

the fragrance components, there would 

be at most a negligible exposure to 

surface water or ground water. 

Therefore, the use of these fragrance 

components as inert ingredients is not 

expected to contribute to dietary 

exposure from drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticide, and flea 

and tick control on pets). 

The use of the fragrance components 

in food contact surface antimicrobial 

pesticide products could result in shortand intermediate-term residential 

exposures, adult handler dermal and 

inhalation exposure; post-application 

dermal and inhalation exposure and 

child’s post- application dermal and 

incidental oral exposure. In addition, 

non pesticidal uses of these substances 

as fragrance components in consumer 

products may also result in residential 

dermal and inhalation exposure. 

However, these pesticidal and non 

pesticidal non-dietary exposures would 

be negligible in comparison to the 

highly conservative estimates of dietary 

exposure as discussed in Unit III.C.1. 

above. Further information regarding 

EPA standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

trac/science/trac6a05.pdf. 

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 


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cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found the fragrance 

components listed in Unit II. to share a 

common mechanism of toxicity with 

any other substances, and these 

fragrance components do not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that these fragrance 

components do 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. 

The use of a threshold exposure level 

as described in Unit II. above is health 

protective of any toxicity to infants and 

children and the exposure assumptions 

utilized in the risk assessment of the 

fragrance components are highly 

conservative (protective). These 

assessments will not underestimate the 

exposure and risks posed by these 

fragrance components and no additional 

safety factor is needed for assessing risk 

to infants and 

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, the fragrance 

components are 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 chronic exposure to each of the 

fragrance components listed in Unit II. 

from food and water will utilize 23% of 

the safe exposure level for the U.S. 

population and all subpopulations. 

3. From non-dietary exposure. The 

fragrance components listed in Unit II. 

may be utilized in antimicrobial 

pesticide products with uses that could 

result in residential exposure such as 

hard surface cleaning products. For 

residential handler exposure, the 

Agency assumed that most residential 

use will result in short-term (1 to 30 

days) dermal and inhalation exposures. 

The Agency assumed that postapplication exposure in residential 

settings is expected to be short-term in 

duration only but antimicrobial 

products used as cleaning agents may be 

used in facilities where cleaning 

activities can occur on an intermediateterm basis. Therefore, these postapplication scenarios were included in 

the intermediate-term aggregate 

assessment. The scenarios evaluated 

were short- and intermediate term postapplication dermal and inhalation 

(indoor), short- and intermediate-term 

incidental oral ingestion from treated 

indoor surfaces (hand-to-mouth vinyl/

hard surfaces). 

Further information regarding EPA 

standard assumptions and generic 

inputs for residential exposures may be 

found at http://www.epa.gov/pesticides/ 

science/residential-exposure-sop.html. 

4. 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). 

These fragrance components may be 

utilized as inert ingredients in pesticide 

formulations registered for uses that 

could result in short-term residential 

exposure, and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to the fragrance components 

listed in Unit II. 

Using the exposure assumptions 

described in this unit for short-term 

exposures, EPA has concluded the 

combined short-term food, water, and 

residential exposures result in aggregate 

exposures for each of the individual 

fragrance components listed in Unit II. 

do not exceed 24% of the safe exposure 

level (i.e., a level equivalent to a PAD 

or RfD) and therefore are not of concern. 

5. 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). 

Using the exposure assumptions 

described in this unit for intermediateterm exposures, EPA has concluded that 

the combined intermediate-term food, 

water, and residential exposures result 

in aggregate exposures that do not 

exceed 24% of the safe exposure level 

for each of the fragrance components 

listed in Unit II. and not of concern. 

6. Aggregate cancer risk for U.S. 

population. Based on the lack of 

structural alerts for carcinogenicity and 

the lack of exceedance of the chronic 

TTC value, the fragrance components 

listed in Unit II. are not expected to 

pose a cancer risk to humans. 

7. Determination of safety. Based on 

these risk assessments, 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 residues of 

each of the fragrance components listed 

in Unit II. Therefore EPA is proposing 

to exempt from the requirement of a 

tolerance under 40 CFR 180.940(a) the 

residues of acetaldehyde, acetic acid, 

allyl cyclohexyl propionate, butryic 

acid, butyl alcohol, citral, citronellol, 

citronellyl acetate, b-damascone, (Z)-, 

decanal, (E)-4-decenal, decanoic acid, 

1-decanol, 2,6-dimethyl-5-heptanal, 

2-dodecanol, (2E)-, d-limonene, ethyl 2- 

methylbutyrate, (E)-geraniol, 

(E)-geraniol acetate, heptanal), 

heptanoic acid, heptyl alcohol, hexanal, 

hexanoic acid, (Z)-3-hexenol, (Z)-3- 

hexenol acetate, hexyl acetate, hexyl 

alcohol, lauric acid, lauric aldehyde, 

lauryl alcohol), methyl-a-ionone, 3- 

methyl-2-butenyl acetate, 2- 

methylundecanal, myristaldehyde, 

myristic acid, neryl acetate, n-hexanol, 

nonanal, nonanoic acid, nonyl alcohol, 

octanal, octanoic acid, 1-octanol, 

palmitic acid, propionic acid, stearic 

acid, 2-tridecanal, 3,5,5- 

trimethylhexanal, undecanal, undecyl 

alcohol, valeraldehyde, and valeric acid. 


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IV. 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. The 

use limitation of 100 ppm will be 

enforced through the pesticide 

registration process under the FIFRA, 7 

U.S.C. 136 et seq. EPA will not register 

any food-contact use antimicrobial 

pesticide for sale or distribution 

containing any of the fragrance 

components listed in Unit II. at 

concentrations exceeding 100 ppm. 

V. Conclusion 

An exemption from the requirement 

for a tolerance is proposed for residues 

of acetaldehyde, acetic acid, allyl 

cyclohexyl propionate, butryic acid, 

butyl alcohol, citral, citronellol, 

citronellyl acetate, b-damascone, (Z)-, 

decanal, (E)-4-decenal, decanoic acid, 1- 

decanol, 2,6-dimethyl-5-heptanal, 2- 

dodecanol, (2E)-, d-limonene, ethyl 2- 

methylbutyrate, (E)-geraniol, (E)- 

geraniol acetate, heptanal), heptanoic 

acid, heptyl alcohol, hexanal, hexanoic 

acid, (Z)-3-hexenol, (Z)-3-hexenol 

acetate, hexyl acetate, hexyl alcohol, 

lauric acid, lauric aldehyde, lauryl 

alcohol), methyl-a-ionone, 3-methyl-2- 

butenyl acetate, 2-methylundecanal, 

myristaldehyde, myristic acid, neryl 

acetate, n-hexanol, nonanal, nonanoic 

acid, nonyl alcohol, octanal, octanoic 

acid, 1-octanol, palmitic acid, propionic 

acid, stearic acid, 2-tridecanal, 3,5,5- 

trimethylhexanal, undecanal, undecyl 

alcohol, valeraldehyde, and valeric acid 

when used as inert ingredients 

(fragrance components) in antimicrobial 

pesticide formulations for use on food 

contact surfaces in public eating places, 

dairy processing equipment, and food 

processing equipment and utensils at 

end-use concentrations not to exceed 

100 ppm. 

VI. Statutory and Executive Order 

Reviews 

This document proposes to establish 

exemptions from tolerances under 

FFDCA section 408(d). The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled ‘‘Regulatory Planning and 

Review’’ (58 FR 51735, October 4, 1993). 

Because this proposed rule has been 

exempted from review under Executive 

Order 12866 due to its lack of 

significance, this proposed rule is not 

subject to Executive Order 13211, 

entitled ‘‘Actions Concerning 

Regulations That Significantly Affect 

Energy Supply, Distribution, or Use’’ (66 

FR 28355, May 22, 2001). This proposed 

rule does not contain any information 

collections subject to OMB approval 

under the Paperwork Reduction Act 

(PRA) (44 U.S.C. 3501 et seq.), or 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II. of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

(2 U.S.C. 1501 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); 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) (15 U.S.C. 272 note). The 

Agency hereby certifies under the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) that this proposed 

action will not have significant negative 

economic impact on a substantial 

number of small entities. Establishing 

an a pesticide tolerance or an exemption 

from the requirement of a pesticide 

tolerance is, in effect, the removal of a 

regulatory restriction on pesticide 

residues in food and thus such an action 

will not have any negative economic 

impact on any entities, including small 

entities. 

In addition, the Agency has 

determined that this action will not 

have a substantial direct effect on States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

‘‘Federalism’’ (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This proposed 

rule directly regulates growers, food 

processors, food handlers, and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of FFDCA section 408(n)(4). 

For these same reasons, the Agency has 

determined that this proposed rule does 

not have any ‘‘tribal implications’’ as 

described in Executive Order 13175, 

entitled ‘‘Consultation and Coordination 

with Indian Tribal Governments’’ (65 FR 

67249, November 9, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes.’’ This 

proposed rule will not have substantial 

direct effects on tribal governments, on 

the relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this proposed rule. 

VII. References 

1. Munro, I.C. A Procedure for the Safety 

Evaluation of Flavouring Substances. 

Toxicological evaluation of certain food 

additives and contaminants. Joint FAO/ 

WHO Expert Committee on Food 

Additives. WHO Food Additive Series 

35, Annex 5. 1996. http://

www.inchem.org/documents/jecfa/

jecmono/v35je21.htm. 

2. Cramer, G. M., Ford, R. A., Hall, R. L. 

Estimation of Toxic Hazard—A Decision 

Tree Approach. Food and Cosmetic 

Toxicology. Vol. 16 pp. 255–276. 1978 

3. Rulis, A.M. De minimis and the Threshold 

of Regulation. Food Protection 

Technology Proceedings of the 1986 

Conference for Food Protection. Eds 

Felix, C.W. Lewis Publishing, Inc. 

Chelsea, Michigan. pp. 29–37. 1986. 

4. Rulis, A.M. Establishing a Threshold of 

Regulation. Risk Assessment in Setting 

National Priorities. Eds Bonin, J.J., 

Stevenson, D.E. Plenum Publishing 

Corporation, New York. pp. 271–278. 

1989. 

5. Rulis, AM. Threshold of Regulation: 

Options for Handling Minimal Risk 

Situations. Food Safety Assessment, 

Chapter 14, Eds Finlay, J.W., Robinson, 

S.F., Armstrong, D.J. American Chemical 

Society Symposium Series No. 484. 


emcdonald on DSK67QTVN1PROD with PROPOSALS
43356 Federal Register / Vol. 79, No. 143 / Friday, July 25, 2014 / Proposed Rules 

American Chemical Society, 

Washington, DC. pp 132–139. 1992. 

6. U.S. Food and Drug Administration (FDA). 

Food Additives: Threshold of Regulation 

for Substances Used in Food-Contact 

Articles. Federal Register (60 FR 36582– 

36596, Monday, July 17, 1995). 

7. Kroes, R., Renwick, A. G., Cheeseman, et 

al. Structure-based Thresholds of 

Toxicological Concern (TTC): Guidance 

for Application to Substances Present at 

Low Levels in the Diet. Food and 

Chemical Toxicology. Vol. 42 pp. 65–83. 

2004. 

8. EFSA Scientific Committee. Scientific 

Opinion on Exploring Options for 

Providing Advice About Possible Human 

Health Risks Based on the Concept of 

Threshold of Toxicological Concern 

(TTC). EFSA Journal 2012;10 (7):2750 

103 pp. doi:10.2903/j.efsa.2012.2750. 

www.efsa.europa.eu/efsajournal. 

9. European Food Safety Authority. Scientific 

Opinion on Flavouring Group Evaluation 

95 (FGE.95): Consideration of aliphatic, 

linear or branched-chain saturated and 

unsaturated alcohols, aldehydes, acids 

and related esters evaluated by JECFA 

(69th meeting) structurally related to 

esters of branched- and straight-chain 

aliphatic saturated primary alcohols and 

of one secondary alcohol, and branchedand straight-chain unsaturated 

carboxylic acids evaluated by EFSA in 

FGE.05Rev1 (2008). EFSA Journal 2010; 

8(11):1207. 51 pp. doi:10.2903/

j.efsa.2010.1207. http://

www.efsa.europa.eu/en/efsajournal/doc/

1207.pdf. 

10. Fukayama, M.Y., Easterday, O.D., 

Serafino, P.A., et al. Subchronic 

Inhalation Studies of Complex Fragrance 

Mixtures in Rats and Hamsters. Toxicol 

Lett. 20;111(1–2). pp. 175–187. 1999. 

11. U.S. Environmental Protection Agency. 

Reregistration Eligibility Decision for 

Alkyl Dimethyl Benzyl Ammonium 

Chloride (ADBAC). pp. 15–16. 2006. 

http://www.epa.gov/pesticides/

reregistration/REDs/adbac_red.pdf. 

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 14, 2014. 

Jack Housenger, 

Director, Office of Pesticide Programs. 

Therefore, it is proposed that 40 CFR 

chapter I be amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

Authority: 21 U.S.C. 321(q), 346a and 371. 

■ 2. In § 180.940, add alphabetically the 

following inert ingredients to the table 

in paragraph (a) to read as follows: 

§ 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 

Acetaldehyde ............................................. 75–07–0 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Acetic acid ................................................. 64–19–7 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Allyl cyclohexyl propionate ........................ 2705–87–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Butryic acid ................................................ 107–92–6 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Butyl alcohol .............................................. 71–36–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Citral .......................................................... 5392–40–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Citronellol .................................................. 106–22–9 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Citronellyl acetate ...................................... 150–84–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

b-Damascone, (Z)- .................................... 23726–92–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Decanal ..................................................... 112–31–2 When ready for use, the end-use concentration is not to exceed 100 ppm. 

(E)-4-Decenal ............................................ 65405–70–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Decanoic acid ............................................ 334–48–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

1-Decanol .................................................. 112–30–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

2,6-Dimethyl-5-heptanal ............................ 106–72–9 When ready for use, the end-use concentration is not to exceed 100 ppm. 

2-Dodecanol, (2E)- .................................... 20407–84–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Ethyl 2-methylbutyrate .............................. 452–79–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

(E)-Geraniol ............................................... 106–24–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

(E)-Geraniol acetate .................................. 105–87–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Heptanal .................................................... 111–71–7 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Heptanoic acid .......................................... 111–14–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Heptyl alcohol ............................................ 111–70–6 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Hexanal ..................................................... 66–25–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Hexanoic acid ............................................ 142–62–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

n-Hexanol .................................................. 111–27–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

(Z)-3-Hexenol ............................................ 928–96–1 When ready for use, the end-use concentration is not to exceed 100 ppm. 

(Z)-3-Hexenol acetate ............................... 3681–71–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Hexyl acetate ............................................ 142–92–7 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Hexyl alcohol ............................................. 111–27–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 


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Pesticide chemical CAS Reg. No. Limits 

*******

Lauric acid ................................................. 143–07–7 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Lauric aldehyde ......................................... 112–54–9 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Lauryl alcohol ............................................ 112–53–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

d-Limonene ............................................... 5989–27–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Methyl-a-ionone ........................................ 127–42–4 When ready for use, the end-use concentration is not to exceed 100 ppm.

3-Methyl-2-butenyl acetate ........................ 1191–16–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

2-Methylundecanal .................................... 110–41–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Myristaldehyde .......................................... 124–25–4 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Myristic acid .............................................. 544–63–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Neryl acetate ............................................. 141–12–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Nonanal ..................................................... 124–19–6 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Nonanoic acid ........................................... 112–05–0 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Nonyl alcohol ............................................. 143–08–8 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Octanal ...................................................... 124–13–0 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Octanoic acid ............................................ 124–07–2 When ready for use, the end-use concentration is not to exceed 100 ppm. 

1-Octanol ................................................... 111–87–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Palmitic acid .............................................. 57–10–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Propionic acid ............................................ 79–09–4 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

Stearic acid ............................................... 57–11–4 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

2-Tridecanal .............................................. 7774–82–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

3,5,5-Trimethylhexanal .............................. 5435–64–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Undecanal ................................................. 112–44–7 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Undecyl alcohol ......................................... 112–42–5 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Valeraldehyde ........................................... 110–62–3 When ready for use, the end-use concentration is not to exceed 100 ppm. 

Valeric acid ................................................ 109–52–4 When ready for use, the end-use concentration is not to exceed 100 ppm. 

*******

* * * * * 

[FR Doc. 2014–17613 Filed 7–24–14; 8:45 am] 

BILLING CODE 6560–50–P 


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