39450 Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Rules and Regulations 

Management and Budget, with an 

explanation of why using these 

standards would be inconsistent with 

applicable law or otherwise impractical. 

Voluntary consensus standards are 

technical standards (e.g., specifications 

of materials, performance, design, or 

operation; test methods; sampling 

procedures; and related management 

systems practices) that are developed or 

adopted by voluntary consensus 

standards bodies. 

This rule does not use technical 

standards. Therefore, we did not 

consider the use of voluntary consensus 

standards. We received no comments 

with regard to this rule and no changes 

have been made to this rule as proposed 

in the NPRM. 

Environment 

We have analyzed this rule under 

Department of Homeland Security 

Management Directive 023–01 and 

Commandant Instruction M16475.lD, 

which guide the Coast Guard in 

complying with the National 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have concluded this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule is categorically 

excluded, under figure 2–1, paragraph 

(34)(h), of the Instruction. This rule 

involves the establishment of a special 

local regulation issued in conjunction 

with a permitted powerboat race event. 

The environmental analysis conducted 

for the powerboat race event permit 

included an analysis of the impact of 

the special local regulation. Based on 

our preliminary determination, there are 

no factors in this case that would limit 

the use of a categorical exclusion under 

section 2.B.2 of the Instruction. 

Therefore, we believe that this rule 

should be categorically excluded, under 

figure 2–1, paragraph (34)(h), of the 

Instruction, from further environmental 

documentation. Under figure 2–1, 

paragraph (34)(h), of the Instruction, an 

environmental checklist and categorical 

exclusion determination is not required 

for this rule. 

List of Subjects in 33 CFR Part 100 

Marine safety, Navigation (water), 

Reporting and recordkeeping 

requirements, Waterways. 

■ For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 100 as follows: 

PART 100—SAFETY OF LIFE ON 

NAVIGABLE WATERS 

■ 1. The authority citation for part 100 

continues to read as follows: 

Authority: 33 U.S.C. 1233. 

■ 2. Add a new temporary § 100.T09– 

0238 as follows: 

§ 100.T09–0238 Special Local Regulation; 

Detroit APBA Gold Cup; Detroit River; 

Detroit, MI. 

(a) Location. The following is a 

temporary special local regulation area: 

All waters of the Detroit River, between 

Detroit, MI and Belle Isle, within an area 

bound on the west by a north-south line 

created by the Belle Isle Bridge, starting 

on land in Detroit at position 42°20′07′′ 

N; 083°00′00′′ W and extending south to 

a point on Belle Isle at position 

42°20′04′′ N; 082°59′08′′ W, and bound 

on the east by a north-south line starting 

on land in Detroit at position 42°21′03′′ 

N; 082°57′07′′ W, and extending south to 

a point on Belle Isle at position 

42°21′00′′ N; 082°57′07′′ W. (DATUM: 

NAD 83). 

(b) Effective Period. This regulation is 

effective from 7 a.m. on July 7, 2010, to 

7 p.m. on July 11, 2010. This regulation 

will be enforced daily from 7 a.m. until 

7 p.m. on July 7–11, 2010. 

(c) Regulations. 

(1) In accordance with the general 

regulations in Section 100.35 of this 

part, entry into, and transiting or 

anchoring within this special local 

regulation area is prohibited unless 

authorized by the Captain of the Port 

Detroit, or his designated on-scene 

representative. 

(2) This special local regulation area 

is closed to all vessel traffic, except as 

may be permitted by the Captain of the 

Port Detroit or his designated on-scene 

representative. 

(3) The ‘‘on-scene representative’’ of 

the Captain of the Port is any Coast 

Guard commissioned, warrant, or petty 

officer who has been designated by the 

Captain of the Port to act on his behalf. 

The on-scene representative of the 

Captain of the Port will be aboard either 

a Coast Guard or Coast Guard Auxiliary 

vessel. The Captain of the Port or his 

designated on-scene representative may 

be contacted via VHF Channel 16. 

(4) Vessel operators desiring to enter 

or operate within the special local 

regulation area shall contact the Captain 

of the Port Detroit or his on-scene 

representative to obtain permission to 

do so. Vessel operators given permission 

to enter or operate in the special local 

regulation area must comply with all 

directions given to them by the Captain 

of the Port or his on-scene 

representative. 

Dated: June 14, 2010. 

J.E. Ogden, 

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

Port Detroit. 

[FR Doc. 2010–16716 Filed 7–7–10; 11:15 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0237; FRL–8831– 4] 

Terpene Constituents of the Extract of 

Chenopodium ambrosioides near 

ambrosioides (α-Terpinene, d-Limonene 

and p-Cymene) as Synthetically 

Manufactured; 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 Terpene 

Constituents of the Extract of 

Chenopodium ambrosioides near 

ambrosioides (a-terpinene, d-limonene 

and p-cymene) as Synthetically 

Manufactured in or on all food 

commodities when applied/used as a 

biochemical insecticide and acaricide. 

AgraQuest, Incorporated submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of Terpene Constituents of 

the Extract of Chenopodium 

ambrosioides near ambrosioides (aterpinene, d-limonene and p-cymene) as 

Synthetically Manufactured under 

FFDCA. 

DATES: This regulation is effective July 

9, 2010. Objections and requests for 

hearings must be received on or before 

September 7, 2010, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2009–0237. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 


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copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The Docket 

Facility is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Chris Pfeifer, Biopesticides and 

Pollution Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0031; e-mail address: 

pfeifer.chris@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. How Can I File an Objection or 

Hearing Request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0237 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 7, 2010. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2009–0237, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: OPP Regulatory Public Docket 

(7502P), Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of May 6, 2009 

(74 FR 20946) (FRL–8411–2), EPA 

issued a notice pursuant to section 

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

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

pesticide tolerance petition (PP 9F7551) 

by AgraQuest, Incorporated, 1540 Drew 

Avenue, Davis, CA 95618–6320. The 

petition requested that 40 CFR part 180 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of Terpene 

Constituents of the Extract of 

Chenopodium ambrosioides near 

ambrosioides (a-terpinene, d-limonene 

and p-cymene) as Synthetically 

Manufactured. The notice referenced a 

summary of the petition prepared by the 

petitioner, AgraQuest, Incorporated, 

which is available in the docket, http:// 

www.regulations.gov. There were no 

comments received in response to the 

notice of filing. 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the exemption is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Pursuant to 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue. . . .’’ 

Additionally, section 408(b)(2)(D) of 

FFDCA requires that the Agency 

consider ‘‘available information 

concerning the cumulative effects of a 

particular pesticide’s residues and other 

substances that have a common 

mechanism of toxicity.’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

Consistent with section 408(b)(2)(D) 

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness, and reliability and the 

relationship of this information to 

human risk. EPA has also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 


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A. Overview 

This active ingredient is a synthetic 

blend of the pesticidally active terpene 

constituents that are found in the 

Extract of Chenopodium ambrosioides 

near ambrosioides. Plant extracts are 

comprised of many constituents, some 

of which give the extract its pesticidal 

effects. The concentration of each of the 

terpene constituents is the same as that 

of the natural extract. 

There are non-terpene constituents in 

this synthetically manufactured extract. 

These non-terpene constituents are 

pesticidally inactive and virtually nontoxic. Likewise, there are non-terpene 

constituents that are found in the 

natural extract. The non-terpene 

constituents found in both the natural 

extract and this synthetically 

manufactured extract have been 

assessed by EPA and determined not to 

be of toxicological concern when used 

in pesticide products applied to various 

food crops. 

The terpene constituents of this 

synthetically manufactured extract and 

the natural extract are the same and 

therefore this tolerance exemption 

document focuses only on the terpene 

constituents. In addition, based on this 

determination, the toxicological 

information submitted in support of the 

tolerance exemption for Extract of 

Chenopodium ambrosioides near 

ambrosioides were used to bridge to 

satisfy the data requirements for this 

synthetically manufactured extract (74 

FR 629, January 7, 2009). 

B. Constituents of ECANA as 

Synthetically Manufactured 

The three major terpene constituents 

of this synthetically manufactured 

extract are a-terpinene, p-cymene, and 

d-limonene. These terpene constituents 

occur naturally in fruits, vegetables, 

herbs, spices, and other foods and 

beverages. These three terpene 

constituents are found naturally in food, 

permitted as food and fragrance 

additives in the United States (U.S.) and 

Europe, and have been fully 

characterized by EPA and assessed for 

their uses in pesticide products applied 

to various food crops (Science Review 

in Support of the Registration of the 

Active Ingredient ECANA, February 

2008; Science Review and Tolerance 

Exemption Petition Review in Support 

of the Registration of Requiem, October 

2008). A summary description of the 

Agency’s dietary exposure to the 

terpene constituents follows: 

1. a-Terpinene is found in the 

essential oils of a variety of plants, 

including citrus, peppermint, thyme, 

basil, and papaya. Per 21 CFR 172.515, 

a-terpinene is permitted for direct 

addition to food for human 

consumption. 

2. d-Limonene is a major terpene 

constituent of lemon oil, orange oil, and 

grapefruit oil; a minor terpene 

constituent of other fruits, vegetables, 

meats, and spices; widely used as a 

flavor and fragrance; and generally 

recognized as safe (GRAS) by the Food 

and Drug Administration (FDA) as a 

food additive or flavoring and as a 

fragrance additive (21 CFR 182.60). 

Furthermore, d-limonene is a federally 

registered active ingredient in 15 

pesticide products with a tolerance per 

40 CFR 180.539. It is also used as a 

solvent or fragrance in 14 other food use 

pesticide products, where it is exempt 

from the requirement of a tolerance as 

an inert ingredient (40 CFR 180.910 and 

40 CFR 180.930). 

3. Humans regularly consume pcymene through such foods as butter, 

carrots, nutmeg, orange juice, oregano, 

raspberries, lemon oil, and spices. pCymene is permitted by FDA for direct 

addition to food as a flavoring substance 

(21 CFR 172.515). 

The general public is exposed daily to 

low levels of these terpene constituents 

via ingestion, dermal contact, and 

inhalation through consumption of 

foods and beverages, as well as through 

dermal contact with cosmetics, in 

excess of any exposure expected to 

result from the pesticidal use of this 

synthetically manufactured extract, all 

without toxicological incident to 

humans. The per capita daily 

consumption of these terpene 

constituents as food additives alone 

amounts to 13.325 milligrams (mg) in 

the U.S. and 40.397 mg in Europe (Ref. 

4), amounts far in excess of any 

potential dietary exposures resulting 

from exposure to residues from this 

pesticidal extract. 

C. Biochemical Pesticide Human Health 

Assessment Data Requirements 

Acute toxicity data were submitted for 

this synthetically manufactured extract; 

all other toxicity information submitted 

in support of the registration and food 

use of this synthetically manufactured 

extract were bridged from the natural 

extract summaries of the toxicological 

data supporting this exemption from the 

requirement of a tolerance are as 

follows: 

1. Acute toxicity. Acute toxicity 

studies, submitted to support the 

registration of the end-use product (EP) 

containing this synthetically 

manufactured extract indicate a low 

toxicity profile and support the finding 

that this active ingredient poses no 

significant human health risk with 

regard to food use. 

a. The acute oral median lethal dose 

(LD50) in rats for this synthetically 

manufactured extract was greater than 

2,000 milligrams per kilogram (mg/kg) 

and confirmed negligible toxicity 

through the oral route. There were no 

observed toxicological effects on the test 

subjects in the the acute oral. (Master 

Record Identification Number (MRID 

No.) 4762704). This synthetically 

manufactured extract is Toxicity 

Category III for acute oral toxicity. 

b. The acute dermal LD50 in rats was 

greater than 2,000 mg/kg for this 

synthetically manufactured extract. No 

toxic endpoints were established. These 

data substantiated this synthetically 

manufactured extract’s relative dermal 

nontoxicity to the general public (MRID 

No. 4762705). This synthetically 

manufactured extract is Toxicity 

Category III for acute dermal toxicity. 

c. The acute inhalation median lethal 

concentration (LC50) for this 

synthetically manufactured extract was 

greater than 2.03 milligrams per liter 

(mg/L) in rats and showed no significant 

inhalation toxicity. No toxic endpoints 

were established. This synthetically 

manufactured extract was tested to a 

limit dose of 5.14 mg/L (MRID No. 

48064401). This synthetically 

manufactured extract is Toxicity 

Category IV for acute inhalation toxicity. 

d. Skin irritation studies on rabbits 

indicated that this synthetically 

manufactured extract was an irritant to 

the skin (MRID No. 48064403). This 

synthetically manufactured extract is 

Toxicity Category IV for dermal 

irritation. 

e. Data indicated this synthetically 

manufactured extract is not a dermal 

sensitizer (MRID No. 48064404). 

Data indicate that this synthetically 

manufactured extract is not acutely 

toxic. No toxic endpoints were 

established, and no significant 

toxicological effects were observed in 

any of the acute toxicity studies. 

2. Mutagenicity. Three mutagenicity 

studies, using the natural extract as the 

test substance, were bridged to support 

this synthetically manufactured extract. 

These studies are sufficient to confirm 

that there are no expected dietary or 

non-occupational risks of mutagenicity 

with regard to new food uses for this 

synthetically manufactured extract. 

Although the natural extract and this 

synthetically manufactured extract have 

non-terpene constituents that are 

different, none of the constituents have 

been shown to present any mutagenicity 

or any impact on mutagenicity and 

therefore, the data submitted to support 

the natural extract demonstrates the lack 


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of mutagenicity of this synthetically 

manufactured extract. 

a. The Reverse Mutation Assay (MRID 

No. 46456301) showed that the natural 

extract did not induce mutant colonies 

relative to control groups. 

b. The In vitro Mammalian Cells in 

Culture Assay (MRID No. 46396214) 

demonstrated that the natural extract 

did not damage chromosomes in human 

lymphocyte cells. 

c. A Deoxyribonucleic Acid (DNA) 

Repair Assay (MRID No. 46396215) 

indicated no unscheduled DNA repair 

in rat hepatocytes exposed to the natural 

extract. 

3. Subchronic toxicity. When used as 

a contact insecticide, residues of this 

synthetically manufactured extract are 

not expected to result in any repeated 

and/or long-term exposure by the oral, 

dermal, or inhalation routes. As a result, 

waiver requests for the subchronic 

toxicity studies were approved, for the 

most part, based upon three residue 

studies for the natural extract, which 

confirm the rapid degradation of the 

terpene constituents in this 

synthetically manufactured extract. 

a. A residue decline study on 

primrose (MRID No. 47209101) 

demonstrated that, when an EP 

containing the natural extract was 

applied at four times the labeled 

application rate, the terpene 

constituents were not detectable 10 

minutes after application. 

b. In another study, an EP containing 

the natural extract was applied to 

tomatoes four times and at twice the 

labeled application rate (MRID No. 

46858903); residues of the terpene 

constituents were below the limit of 

quantitation (LOQ) of 0.01 mg/kg when 

plant samples were collected and 

checked at 0, 3, 6, and 24–hour 

intervals. 

c. In the final study (MRID No. 

47548301), an EP containing the natural 

extract was applied to mustard greens 

three times and at twice the labeled 

application rate; residues of the terpene 

constituents had dissipated to below the 

LOQ of 0.05 parts per million (ppm) at 

1–4 hours after the last application. 

These residue decline studies on the 

natural extract support the finding that 

there is little potential for dermal or 

inhalation exposure to residues of this 

synthetically manufactured extract 

based on the rapid degradation of the 

terpene constituents that are the 

principal constituents in the natural 

extract and this synthetically 

manufactured extract. Therefore, no 

subchronic testing is needed. 

4. Developmental toxicity. The 

Agency bridged from information on the 

natural extract to support this 

synthetically manufactured extract. The 

information from the open scientific 

literature characterizes the 

developmental toxicity of the terpene 

constituents and satisfies the data 

requirements for developmental and 

reproductive toxicity for this 

synthetically manufactured extract 

(Refs. 1, 2, 3, and 4). The information 

established that none of the terpene 

constituents in this synthetically 

manufactured extract are developmental 

or reproductive toxicants. The data 

submitted to support the natural extract 

appropriately demonstrates the lack of 

developmental toxicity of this 

synthetically manufactured extract. 

The information established a 

conservative maternal no observable 

adverse effect level (NOAEL) of 60 mg/ 

kg per day and a developmental NOAEL 

of 30 mg/kg per day. These levels 

greatly exceed any potential dietary 

exposure, as discussed above in Unit 

III.C.3., from the use of this 

synthetically manufactured extract and 

confirm the lack of risk for 

developmental toxicity, even in a worstcase scenario. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

A. Dietary Exposure 

Dietary exposure to the residues of 

this synthetically manufactured extract 

is expected to be virtually nonexistent. 

Even in the event of exposure, the 

information supporting this tolerance 

exemption demonstrates that any 

dietary risks would be negligible. 

1. Food. The pesticidal use of this 

synthetically manufactured extract is 

not expected to result in any dietary 

exposure. Three residue decline studies 

on the natural extract show that rapid 

degradation of the terpene constituents 

of this synthetically manufactured 

extract. A detailed discussion of those 

studies can be found in Unit III.C.3. In 

sum, these data demonstrate that, by the 

time this synthetically manufactured 

extract has dried on the plant, there is 

no detectable residual product. 

2. Drinking water exposure. Exposure 

of humans to this synthetically 

manufactured extract in drinking water 

is unlikely because associated pesticide 

products are labeled for applications 

directly to terrestrial plants and because 

any residues would have significantly 

degraded in the advance of any rainfall 

event. Low application rates and rapid 

biodegradation in water (an aqueous 

half life of 36.11 hours for the natural 

extract) further reduce the potential for 

drinking water exposure. 

B. Other Non-Occupational Exposure 

Non-occupational exposure is not 

expected because this synthetically 

manufactured extract is not approved 

for residential uses and the active 

ingredient is applied directly to food 

commodities and degrades rapidly. 

1. Dermal exposure. Nonoccupational dermal exposures to this 

synthetically manufactured extract are 

expected to be negligible because of its 

directed agricultural use. In the event of 

dermal exposure to residues, because of 

the non-toxic profile of this 

synthetically manufactured extract (as 

described in Unit III.), use of this 

synthetically manufactured extract is 

not expected to result in any risks 

through this route of exposure. 

2. Inhalation exposure. Nonoccupational inhalation exposures are 

not expected to result from the 

agricultural uses of this synthetically 

manufactured extract. Any inhalation 

exposure associated with this 

agricultural use pattern is expected to be 

occupational in nature. 

V. Cumulative Effects from Substances 

with a Common Mechanism of Toxicity 

Section 408(b)(2)(D)(v) of FFDCA 

requires that, when considering whether 

to establish, modify, or revoke a 

tolerance, the Agency consider 

‘‘available information’’ concerning the 

cumulative effects of a particular 

pesticide’s residues and ‘‘other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found this synthetically 

manufactured extract to share a 

common mechanism of toxicity with 

any other substances, and this 

synthetically manufactured extract does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that this 

synthetically manufactured extract does 

not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine which chemicals have a 

common mechanism of toxicity and to 

evaluate the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 


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VI. Determination of Safety for the U.S. 

Population, Infants, and Children 

FFDCA section 408(b)(2)(C) provides 

that EPA shall assess the available 

information about consumption patterns 

among infants and children, special 

susceptibility of infants and children to 

pesticide chemical residues, and the 

cumulative effects on infants and 

children of the residues and other 

substances with a common mechanism 

of toxicity. In addition, FFDCA section 

408(b)(2)(C) provides that EPA shall 

apply an additional tenfold margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database unless 

EPA determines that a different margin 

of safety will be safe for infants and 

children. Margins of exposure (safety), 

which are often referred to as 

uncertainty factors, are incorporated 

into EPA risk assessments either 

directly or through the use of a margin 

of exposure analysis, or by using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk. 

Health risks to humans, including 

infants and children, are considered 

negligible with regard to the pesticidal 

use of this synthetically manufactured 

extract. Toxicity information submitted 

in support of the application for this 

synthetically manufactured extract 

demonstrates that the active ingredient 

has negligible toxicity. In addition, the 

terpene constituents of this 

synthetically manufactured extract are 

ubiquitous in nature and present in a 

multitude of fruits and vegetables and, 

to date, there is no history of 

toxicological incident involving their 

consumption. As discussed earlier, the 

terpene constituents of this 

synthetically manufactured extract are 

approved as direct food additives by the 

FDA. Most importantly, however, 

exposure to the residues of this 

synthetically manufactured extract are 

not expected. Pesticidal applications are 

applied directly to commercial crops, 

and data confirm that detectable 

residues do not persist beyond the time 

for this synthetically manufactured 

extract to dry on to foliar surfaces. As 

such, the Agency has determined that 

this food use of this synthetically 

manufactured extract poses no 

foreseeable risks to human health or the 

environment. There is a reasonable 

certainty that no harm will result to the 

general U.S. population, including 

infants and children, from aggregate 

exposure to residues of this 

synthetically manufactured extract. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for Terpene Constituents (a-terpinene, 

d-limonene and p-cymene) of the 

Extract of Chenopodium ambrosioides 

near ambrosioides as Synthetically 

Manufactured. 

VIII. Conclusions 

The Agency concludes that there is a 

reasonable certainty that no harm will 

result to the United States population, 

including infants and children, from 

aggregate exposure to residues of this 

synthetically manufactured extract. 

Therefore, an exemption is established 

for residues of Terpene Constituents (aterpinene, d-limonene and p-cymene) of 

the Extract Chenopodium ambrosioides 

near ambrosioides as Synthetically 

Manufactured in or on all food 

commodities. 

IX. References 

1. Araujo IB, Souza CAM, DeCarvalho RR, Kuriyama SN, Rodrigues 

RP, Vollmer RS, Alves EN, Paumgartten 

FJR. 1996. Study of the 

embryofoetotoxicity of a-terpinene in 

the rat. Food and Chemical Toxicology 

34:477–482. 

2. Cornell University. 2008. Medicinal 

Plants Website. Medicinal Plants for 

Livestock, Beneficial or Toxic? 

Available from http:// 

www.ansci.comell.edu/plants/ 

medicinal/plants.html. 

3. Flavor and Fragrance High 

Production Volume Consortia 

(FFHPVC). 2002. The Terpene 

Consortium: Test Plan for Aromatic 

Terpene Hydrocarbons. 

4. World Health Organization (WHO). 

2005. Evaluation of Certain Food 

Additives. WHO Technical Report 

Series No. 928. Sixty-third Report of the 

Joint FAO/WHO Expert Committee on 

Food Additives. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

exemption under section 408(d) of 

FFDCA in response to a petition 

submitted to the Agency. The Office of 

Management and Budget (OMB) has 

exempted these types of actions from 

review under Executive Order 12866, 

entitled Regulatory Planning and 

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

Because this final rule has been 

exempted from review under Executive 

Order 12866, this final rule is not 

subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001), or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance exemption in this final 

rule, do not require the issuance of a 

proposed rule, the requirements of the 

Regulatory Flexibility Act (RFA) (5 

U.S.C. 601 et seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Rules and Regulations 39455 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999), and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000), do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

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

XI. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: June 30, 2010. 

Martha Monell, 

Acting 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 180.1296 is added to 

subpart D to read as follows: 

§ 180.1296 Terpene Constituents αterpinene, d-limonene and p-cymene, of the 

Extract of Chenopodium ambrosioides near 

ambrosioides as Synthetically Manufactured; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for the 

residues of the biochemical pesticide 

Terpene Constituents a-terpinene, dlimonene and p-cymene, of the Extract 

of Chenopodium ambrosioides near 

ambrosioides as Synthetically 

Manufactured when used as an 

insecticide/acaricide in or on all food 

commodities. 

[FR Doc. 2010–16765 Filed 7–8–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1187; FRL–8831–2] 

Homobrassinolide; 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 

homobrassinolide in or on all food 

commodities when applied/used as a 

plant growth regulator in accordance 

with good agricultural practices. Repar 

Corporation submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

homobrassinolide under the FFDCA. 

DATES: This regulation is effective July 

9, 2010. Objections and requests for 

hearings must be received on or before 

September 7, 2010, and must be filed in 

accordance with the instructions 

provided in 40 CFR part 178 (see also 

Unit I.C. of the SUPPLEMENTARY

INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–1187. All documents in the 

docket are listed in the docket index 

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

Although listed in the index, some 

information is not publicly available, 

e.g., Confidential Business Information 

(CBI) or other information whose 

disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available in the electronic docket at 

http://www.regulations.gov, or, if only 

available in hard copy, at the Office of 

Pesticide Programs (OPP) Regulatory 

Public Docket in Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. The Docket 

Facility is open from 8:30 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The Docket Facility telephone 

number is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: John 

Fournier, Biopesticides and Pollution 

Prevention Division (7511P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–0169; e-mail address: 

fournier.john@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. How Can I File an Objection or 

Hearing Request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), any person may file an 

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2007–1187 in the subject line on 


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