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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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–2007–1187, 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 February 

13, 2008 (73 FR 8312) (FRL–8349–2), 

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 7F7296) 

by Repar Corporation, 8070 Georgia 

Avenue, Suite 209, Silver Spring, MD 

20910. The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of homobrassinolide. This notice 

referenced a summary of the petition 

prepared by the petitioner, Repar 

Corporation, which is available in the 

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

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit VII.C. 

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 EPA 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. 

A. Overview of Homobrassinolide 

The active ingredient, 

homobrassinolide, is a plant growth 

regulator that is a synthesized 

homologue of brassinolide, a naturally 

occurring brassinosteroid. 

Brassinosteroids are a group of steroidal 

plant hormones that were discovered in 

1973, when it was shown that pollen 

from rapeseed (Brassica napus) could 

promote stem elongation and cell 

division and that the biologically active 

molecule was a steroid. Brassinosteroids 

are ubiquitously distributed in the plant 

kingdom. Since their discovery, over 70 

brassinosteroids have been isolated from 

plants. The occurrence of these steroids 

has been demonstrated in various plant 

parts, such as pollen, flower buds, fruit 

seeds, vascular cambium, leaves, shoots, 

and roots. Studies on higher plants 

suggest that these steroids play a critical 

role in a range of developmental 

processes (i.e., stem elongation, root 

growth, floral initiation, etc.). 

B. Biochemical Pesticide Human Health 

Assessment Data Requirements 

1. Acute Toxicity. Tier I acute toxicity 

studies showed that homobrassinolide 

is a Toxicity Category IV (low toxicity) 

compound via oral and inhalation 

routes of exposure and a Toxicity 

Category III (slightly toxic) compound 

for dermal and eye exposures. 

Moreover, homobrassinolide is neither a 

skin irritant nor a dermal sensitizer. 

Given the results of these studies, no 

additional toxicity (i.e., Tiers II or III) or 

residue data are required to support 

food uses of this biochemical active 

ingredient. 

i. The acute oral median lethal doses 

(LD50s) for homobrassinolide in rats and 

mice were greater than 5,000 milligrams 

per kilogram (mg/kg) and confirmed 

negligible toxicity through oral exposure 

(Master Record Identification Numbers 

[MRID Nos.] 47185118 and 47208903). 

Homobrassinolide is classified as 

Toxicity Category IV for acute oral 

toxicity. 

ii. The acute dermal median lethal 

dose (LD50) for homobrassinolide in rats 

was over 2,000 mg/kg, which confirmed 

low dermal toxicity (Master Record 

Identification Number [MRID No.] 

47185120). Homobrassinolide is 

classified as Toxicity Category III for 

acute dermal toxicity. 

iii. The acute inhalation median lethal 

concentration (LC50) was greater than 

2.26 milligrams per liter (mg/L) in rats 

and showed practically no inhalation 

toxicity or irritation (MRID No. 

47185121). Homobrassinolide is 

classified as Toxicity Category IV for 

acute inhalation toxicity. 

iv. An acute eye study showed that 

exposure to homobrassinolide will 

cause temporary mild eye irritation 

(MRID No. 47185122). As such, EPA has 

determined that homobrassinolide is 

Toxicity Category III for acute eye 

irritation. Acute dermal irritation and 

skin sensitization studies showed that 

homobrassinolide is non-irritating and 

not a sensitizer to the skin (MRID Nos. 

47185123 and 47185124). EPA has 

determined that homobrassinolide is 

Toxicity Category IV for both dermal 

irritation and dermal sensitization. 


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These acute toxicity studies, 

submitted to support the registration of 

one manufacturing-use product 

containing homobrassinolide, confirm a 

low toxicity profile. 

2. Subchronic Toxicity. i. The 

submitted 90–day oral toxicity (MRID 

No. 47208906) study showed that test 

animals did not exhibit any clinical 

signs of toxicity that were statistically 

different from untreated controls. There 

were no significant changes in organ 

weights (e.g., thymus and spleen) or 

differential white blood cell counts of 

the treated animals during the 90–day 

study period, which would indicate 

potential interference with normal 

immune function. The 90–day oral 

feeding no observable effect level 

(NOEL) for Homobrassinolide Technical 

was 1,000 milligrams per kilogram per 

day. Based on the review of these data, 

EPA concluded that no subchronic oral 

toxicity is expected to occur when this 

compound is used in accordance with 

good agricultural practices. 

ii. Submission of 90–day dermal 

toxicity data was waived by EPA (MRID 

No. 47185136) for primarily two 

reasons. First, dermal metabolism of 

homobrassinolide is not expected to 

differ from its oral metabolism. Acute 

guideline studies demonstrated that 

homobrassinolide has a low dermal 

toxicity (LD50 >2,000 mg/kg), was not a 

dermal irritant, and was not a dermal 

sensitizer. In addition, prolonged 

human dermal exposure is remote as 

brassinosteroids are readily metabolized 

by plants to inactive forms and, 

therefore, the application of 

homobrassinolide to crop plants as a 

plant growth stimulant is unlikely to 

increase levels of brassinosteroids in the 

treated plants. Brassinosteroids are 

present in all plants, resulting in 

ubiquitous exposure to humans and 

other organisms though the food chain 

without causing harm. 

iii. Submission of 90–day inhalation 

data was also waived. The acute 

inhalation toxicity study demonstrates 

homobrassinolide’s lack of toxicity 

(Toxicity Category IV) and there is no 

anticipated repeated inhalation 

exposure under the conditions of 

product use at a concentration that 

could be toxic (MRID No. 47185137). 

3. Developmental Toxicity and 

Mutagenicity. Based on in vivo studies 

using oral applications of 

homobrassinolide, the active ingredient 

did not have the potential to induce 

chromosome aberrations in mice treated 

up to a single oral dose of 2,000 mg/kg 

body weight. The active ingredient did 

not have micronucleus induction 

potential in mice after two days of oral 

dosing up to a level of 2,000 mg/kg body 

weight. Thus, homobrassinolide is nonmutgenic to mice (MRID No. 47208905). 

In vitro studies demonstrated that 

treatment with 100 and 1,000 mg/kg 

body weight of homobrassinolide did 

not result in mortality or overt signs of 

toxicity for pregnant rats during the 

observation period. Body weight 

changes in the groups of test substance 

treated dams were statistically similar to 

controls and no significant changes 

were observed in the weights of ovary 

and fetuses. The test further showed 

that there were no significant changes in 

the uterine weights, as well as, no test 

related recurrent visceral and skeletal 

malformations when compared to 

controls. Based on these findings it 

appears that homobrassinolide is nonteratogenic to Wistar rats at the dose 

levels of 100 and 1000 mg/kg of 

bodyweight (MRID No. 47185132). 

As a result of the findings in these 

studies, EPA concludes that 

homobrassinolide is not mutagenic or 

genotoxic. 

C. References 

Bajguz, A., 2000. Effect of 

brassinosteroids on nuclear acids and 

protein content in cultured cells of 

chlorella vulgaris. Plant Physiol. 

Biochem. 38, 209-215. 

Catterou, M., F. Dubois, H. Schaller, L. 

Aubanella, B. Vilcol, B. S. SangwanNorrel, R.S. Sangwan, 2001. 

Brassinosteroids microtubules and cell 

elongation in Arabidopsis thaliana. II. 

Effects of brassinosteroids on 

microtubules and cell elongation in the 

bull mutant. Planta, 212, 673-683. 

IECVI.I – Individual Effects Chance 

Model Version 1.1. 2004. USEPA/OPP/ 

EFEDSeeta S.R.R., B.V.Vardhini, E. 

Sujatha, S. Anuradha. 2002. 

Brassinosteroids-A new class of 

phytohormones. Current Science, 

82:12391245. 

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 

1. Food. The primary route of 

homobrassinolide exposure to the 

general population is expected to be 

through consumption of food. Dietary 

exposure to homobrassinolide from 

application/use as a plant growth 

regulator is expected to be minimal, 

assuming use consistent with the 

labeling and use of good agricultural 

practices. The approved label allows a 

maximum application rate of 20 grams 

of active ingredient per acre per 

application. In addition, 

homobrassinolide is present in all 

plants, resulting in ubiquitous exposure 

to humans and other organisms through 

the food chain without causing harm. 

The endogenous levels of 

brassinosteroids are in parts per million 

or parts per billion (e.g., brassinosteroid 

levels in pollen have been measured at 

200 parts per billion). The 20 grams per 

acre of homobrassinolide from 

application/use as a plant growth 

regulator is not expected to increase 

natural levels of brassinosteroids in 

treated plants. This is because the 

homobrassinolide applied/used as a 

crop plant will be metabolized as the 

plant grows. 

2. Drinking water exposure. No 

significant drinking water exposure or 

residues are expected to result from the 

use of homobrassinolide as a plant 

growth regulator. The active ingredient 

is intended for use as a foliar 

application on food commodities and is 

not to be applied directly to water. If 

used in accordance with EPA-approved 

labeling and good agricultural practices, 

homobrassinolide is not likely to 

accumulate in drinking water. 

Furthermore, it is doubtful that 

homobrassinolide concentrations in 

water would exceed levels that are 

currently ubiquitous to plants. Although 

fate information is not available on 

homobrassinolide, the compound is not 

soluble in water (water solubility 

3.18%), and the log Pow = 3.96 suggests 

both moderate binding to soil and a low 

probability of ground water 

contamination. Overall, drinking water 

exposure to residues of 

homobrassinolide is expected to be 

minimal. 

B. Other Non-Occupational Exposure 

The potential for non-dietary 

exposure of the general population, 

including infants and children, is 

limited based on the use patterns of 

homobrassinolide. Non-dietary 

exposures would not be expected to 

pose any quantifiable risk to the general 

population. 

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, EPA consider ‘‘available 

information concerning the cumulative 

effects of [a particular pesticide’s] 


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residues and other substances that have 

a common mechanism of toxicity.’’ 

EPA has not found homobrassinolide 

to share a common mechanism of 

toxicity with any other substances, and 

homobrassinolide does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance exemption, therefore, EPA 

has assumed that homobrassinolide 

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. 

VI. Determination of Safety for the 

United States 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. 

Based on the results of the 

toxicological data discussed in Unit III., 

as well as all other available 

information, EPA 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 the residues of 

homobrassinolide. This includes all 

anticipated dietary exposures and all 

other exposures for which there is 

reliable information. EPA has arrived at 

this conclusion based on the low level 

of toxicity of the compound, the 

minimal exposure from application/use 

of homobrassinolide as a plant growth 

regulator, the ubiquitous nature of 

brassinosteroids in the plant kingdom, 

and the already widespread exposure to 

these plant steroids without any 

reported adverse effects on human 

health. Thus, there are no threshold 

effects of concern and, as a result, the 

provision requiring an additional 

margin of safety does not apply in this 

instance. 

VII. Other Considerations 

A. 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 homobrassinolide. 

B. Response to Comments 

A notice of receipt of the application 

for registration of a pesticide product 

containing homobrassinolide (a new 

active ingredient) was published in the 

Federal Register and opened a 30–day 

comment period (73 FR 8312, February 

13, 2008). Two comments were received 

following this publication, but neither 

comment was related to the registration 

of homobrassinolide as a new active 

ingredient (i.e., both referenced a 

pesticide product apparently associated 

with another active ingredient) nor 

provided any substantive basis, such as 

data or other available information, 

supporting their respective positions or 

calling into question any of EPA’s risk 

assessments. 

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 

homobrassinolide applied/used as a 

plant growth regulator in accordance 

with good agricultural practices. 

Therefore, an exemption is established 

for residues of homobrassinolide in or 

on all food commodities when applied/ 

used as a plant growth regulator in 

accordance with good agricultural 

practices. 

IX. 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 

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 


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Federal Register / Vol. 75, No. 131 / Friday, July 9, 2010 / Rules and Regulations 39459 

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). 

X. 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 14, 2010. 

Steven Bradbury, 

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 180.1297 is added to 

subpart D to read as follows: 

§180.1297 Homobrassinolide; exemption 

from the requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for the 

residues of homobrassinolide in or on 

all food commodities when applied/ 

used as a plant growth regulator in 

accordance with good agricultural 

practices. 

[FR Doc. 2010–16771 Filed 7–8–10; 8:45 am] 

BILLING CODE 6560–50–S 


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