Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 5687 

Dated: January 21, 2011. 

Waverly W. Gregory, Jr., 

Chief, Bridge Administration Branch, Fifth 

Coast Guard District. 

[FR Doc. 2011–2224 Filed 2–1–11; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0676; FRL–8860–4] 

Isobutane; 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 isobutane (CAS 

Reg. No. 75–28–5) when used as an inert 

ingredient (propellant) in pesticide 

formulations applied to growing crops 

and raw agricultural commodities after 

harvest, and when used as an inert 

ingredient (propellant) in pesticide 

formulations applied to animals (used 

for food). Landis International, on behalf 

of Whitmire Micro-Gen, submitted a 

petition to EPA under the Federal Food, 

Drug, and Cosmetic Act (FFDCA), 

requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

isobutane. 

DATES: This regulation is effective 

February 2, 2011. Objections and 

requests for hearings must be received 

on or before April 4, 2011 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–2009–0676. 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 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: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; e-mail address: 

fertich.elizabeth@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. To access the 

harmonized test guidelines referenced 

in this document electronically, please 

go to http://www.epa.gov/ocspp and 

select ‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2009–0676 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 April 4, 2011. 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–2009–0676, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(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. Petition for Exemption 

In the Federal Register of October 7, 

2009 (74 FR 51597) (FRL–8792–7), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

9E7586) by Whitmire Micro-Gen, c/o 

Landis International, P.O. Box 5126, 

Valdosta, GA 31603–5126. The petition 

requested that 40 CFR 180.910 and 40 

CFR 180.930 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of isobutane (CAS Reg. No. 75–28–5) 

when used as an inert ingredient 

(propellant) in pesticide formulations 

applied pre- and post-harvest and 

pesticide formulations applied to 

animals. That notice referenced a 

summary of the petition prepared by 


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Landis International, on behalf of 

Whitmire Micro-Gen, the petitioner, 

which is available in the docket, 

http://www.regulations.gov. There were 

no comments received in response to 

the notice of filing. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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

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

reasonable certainty that no harm will 

result from aggregate exposure to the 

pesticide chemical residue, including 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information.’’ This includes 

exposure through drinking water and in 

residential settings, but does not include 

occupational exposure. Section 

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

give special consideration to exposure 

of infants and children to the pesticide 

chemical residue in establishing a 

tolerance and to ‘‘ensure that there is a 

reasonable certainty that no harm will 

result to infants and children from 

aggregate exposure to the pesticide 

chemical residue.* * *’’ 

EPA establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for isobutane 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with isobutane follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered their 

validity, completeness, and reliability as 

well as the relationship of the results of 

the studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

Isobutane is an asphyxiant and acute 

exposure may cause tachypnea and 

tachycardia. While direct contact with 

the liquid may cause burns, the vapor 

has no effects on the skin and eyes. 

Sudden death has also been reported 

from abusive ‘‘sniffing’’ of products 

containing isobutane, especially lighter 

refills. In a safety assessment of 

isobutane as a cosmetic ingredient 

(1982), dermal irritation in humans was 

very slight and transient erythema 

occurred randomly. Repeated inhalation 

exposure did not result in any changes 

in electroencephalograms, 

adrenocortical function, pulmonary 

function, neurological response, 

subjective response, cardiac function or 

cognitive response. 

Acute toxicity data on isobutane were 

limited to inhalation exposure and eye 

and skin irritation. Isobutane was not 

acutely toxic via the inhalation route 

and was basically non-irritating to the 

skin and eyes of rabbits. 

Several studies were found in which 

monkeys, rabbits, and rats were exposed 

to formulations or to mixtures 

containing isobutane. No toxicity was 

reported for two species of monkeys and 

one species of rabbit exposed for 90 

days to various formulations containing 

isobutane. 

No effects on survival, body weight, 

hematology, clinical pathology, or liver 

and kidney weights were observed in 

rats exposed to 0, 1,000, or 4,500 ppm 

(equivalent to 0, 622 or 2,803 

milligrams/kilogram/day (mg/kg/day) of 

a 50:50 mixture of isobutane: isopentane 

for 13 weeks, however clinical signs 

included hunched posture, lethargy and 

crusted eyes in both exposure groups. 

There were no clinical signs of toxicity 

observed and no gross or microscopic 

lesions seen in Sprague-Dawley rats 

exposed to 0, 44, 432, or 4,437 ppm 

(equivalent to 0, 27, 269, or 2,763 mg/ 

kg/day) of a mixture containing 25% 

each of n-butane, isobutane, n-pentane, 

and isopentane for 3 weeks. 

In a 4-week sub-chronic toxicity study 

combined with reproduction/ 

developmental toxicity screening and 

neurotoxicity screening study, Sprague 

Dawley CD rats were treated with 

isobutane (purity 99.0%) to assess the 

repeated dose, reproductive and 

developmental toxicity potential of this 

material when administered by whole 

body inhalation exposure. A noobserved-adverse effect level (NOAEL) 

of 9,000 ppm (equivalent to 5,600 mg/ 

kg/day) was concluded for general 

systemic/neurotoxic (parental) 

endpoints in this study. Based on 

decreased male and female fertility and 

increased post-implantation loss in the 

9,000 ppm group, the fertility and 

reproductive endpoints NOAEL was 

determined to be 3,000 ppm (equivalent 

to 1,867 mg/kg/day). There were no 

effects on offspring survival, body 

weight and development up to postnatal day 4. A NOAEL of 9,000 ppm 

(equivalent to 5,600 mg/kg/day) was 

concluded for developmental effects. No 

effects on functional observational 

battery parameters and motor activity 

were observed in this study. 

In terms of neurotoxicity, acute 

toxicity studies show effects on the 

central nervous system (CNS) with 

rodents more sensitive than dogs. 

Exposure to a concentration of 55% was 

lethal in dogs, while 41–52% was lethal 

to mice within 2–3 minutes. The 

10-minute EC50 for CNS effects was 

listed as 200,000 ppm (equivalent to 

124,560 mg/kg/day) for the rat. 

Several tests were found measuring 

the cardiopulmonary toxicity of 

isobutane. No effects were seen in 

anesthetized Rhesus monkeys exposed 

for 5 minutes to 5% isobutane through 

a tracheal cannula. Effects on the heart 

were shown in the dog with 

concentration-related decreased 


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contractility, pressure, and output 

measured between 2–10% isobutane. 

Mongrel dogs were also anesthetized 

and exposed to isobutane through a 

tracheal cannula. Blood pressure and 

heart rate were not affected by exposure. 

All concentrations significantly 

increased pulmonary resistance and 

decreased pulmonary compliance. 

Similarly, anesthetized male OsburnMendel rats exposed to 27% isobutane 

showed apnea after 8.7 minutes of 

exposure followed by cardiac arrest; 

decreased respiratory rate, tidal volume, 

and pulmonary compliance and 

increased airway resistance were also 

found. In another test with anesthetized 

male Swiss mice, 20–40% isobutane did 

not induce cardiac arrhythmia, but did 

sensitize the heart to epinephrineinduced arrhythmia. 

No evidence of an increase in 

mutation frequency was found in five 

strains of Salmonella typhimurium 

exposed to up to 50% isobutane in air. 

Strains TA98, TA100, TA1535, TA1537, 

and TA1538 were exposed for 6 hours 

with and without metabolic activation. 

No chronic toxicity or carcinogenicity 

studies with isobutane were identified. 

However, the concern for 

carcinogenicity is low based on rapid 

metabolism, lack of mutagenicity and 

lack of systemic toxicity at doses up to 

1,867 mg/kg/day. In addition, the 

Agency used a qualitative structure 

activity relationship (SAR) database, 

DEREK11, to determine if there were 

structural alerts suggestive of 

carcinogenicity. No structural alerts 

were identified. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by, as well as the noobserved-adverse-effect-level (NOAEL) 

and the lowest-observed-adverse-effectlevel (LOAEL) from the toxicity studies 

can be found at http:// 

www.regulations.gov in the document 

‘‘PC Code 800015: Isobutane (CAS Reg. 

No. 75–28–5); Human Health Risk 

Assessment and Ecological Effects 

Assessment to the Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as an Inert 

Ingredient in Pesticide Formulations’’ at 

[6] in docket ID number EPA–HQ–OPP– 

2009–0676. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Due to the low potential hazard of 

isobutane, quantitative dietary, 

occupational and residential exposure 

assessments are not necessary. In a 

4-week sub-chronic toxicity study 

combined with reproduction/ 

developmental toxicity screening and 

neurotoxicity screening study, exposure 

of male and female rats to target 

concentrations of 900, 3,000 or 9,000 

ppm (equivalent to 560, 1,867, and 

5,600 mg/kg/day) of isobutane by 

whole-body inhalation for four weeks 

resulted in no general systemic/ 

neurotoxic effects. Based on decreased 

male and female fertility and increased 

post-implantation loss in the 5,600 mg/ 

kg/day group, the fertility and 

reproductive endpoints NOAEL was 

determined to be 1,867 mg/kg/day. 

There were no effects on offspring 

survival, body weight and development 

up to post-natal day 4. A NOAEL of 

5,600 mg/kg/day was concluded for 

developmental effects. Since no toxicity 

was observed at high doses, quantitative 

risk assessment is deemed unnecessary. 

C. Exposure Assessment 

No hazard was identified for the acute 

and chronic dietary assessment (food 

and drinking water), or for the short-, 

intermediate-, and long-term residential 

assessments, and therefore no aggregate 

risk assessments were performed. 

Available toxicological studies indicate 

lack of systemic toxicity at doses up to 

1,867 mg/kg/day. Therefore, no 

quantitative dietary or occupational and 

residential risk assessment was 

conducted. 

1. Dietary exposure from food and 

feed uses and drinking water. In 

evaluating dietary exposure to 

isobutane, EPA considered exposure 

under the proposed exemption from the 

requirement of a tolerance. Since 

toxicity effects were seen only at high 

doses for isobutane, a quantitative 

exposure assessment for isobutane was 

not conducted. Any possible dietary 

exposure to isobutane from its use as an 

inert ingredient in pesticide products 

would be through consumption of food 

to which pesticide products containing 

it have been applied and possibly 

through drinking water (from runoff). 

Isobutane is expected to exist in the 

atmosphere as a gas and volatilize 

rapidly from surface water and soil. 

This will reduce the amount of 

isobutane that is available for uptake by 

plants. Run-off into surface water is not 

anticipated due to rapid volatization, 

and therefore, contributions of concern 

to drinking water are not expected. 

2. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). 

Isobutane is widely used as a 

propellant in a variety of household 

products, such as cleaners and air 

fresheners. It is also used in nonfood 

use insecticide products and personal 

care products. Considering the low 

toxicity of isobutane, residues of 

concern are not anticipated from 

residential exposures (inhalation and 

dermal) and therefore a quantitative 

aggregate risk assessment was not 

performed. 

3. 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 isobutane to share 

a common mechanism of toxicity with 

any other substances, and does not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that 

isobutane does not have a common 

mechanism of toxicity with other 

substances. For information regarding 

EPA’s efforts to determine which 

chemicals have a common mechanism 

of toxicity and to evaluate the 

cumulative effects of such chemicals, 

see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

Section 408 of the 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 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 supports the 

choice of a different factor. 

The toxicity database is sufficient for 

isobutane and potential exposure is 

adequately characterized given the low 

toxicity of the chemical. In terms of 

hazard, there are low concerns and no 

residual uncertainties regarding prenatal 

and/or postnatal toxicity. In the OECD 

422 study via the inhalation route, the 

NOAEL for general systemic toxicity 

and neurotoxicity was 5,600 mg/kg/day 

(the highest dose tested). Based on 

decreased male and female fertility and 

increased post-implantation loss in the 


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5,600 mg/kg/day group, the fertility and 

reproductive endpoints NOAEL was 

determined to be 1,867 mg/kg/day. 

There were no effects on offspring 

survival, body weight and development 

up to post-natal day 4. A NOAEL of 

5,600 mg/kg/day was concluded for 

developmental effects. Based on this 

information, there is no concern at this 

time for increased sensitivity to infants 

and children to isobutane when used as 

an inert ingredient in pesticide 

formulations and a safety factor analysis 

has not been used to assess risk. For the 

same reason, EPA has determined that 

an additional safety factor is not needed 

to protect the safety of infants and 

children. 

E. Aggregate Risks and Determination of 

Safety 

Given the lack of concern for hazard 

posed by isobutane, EPA concludes that 

there are no dietary or aggregate dietary/ 

non-dietary risks of concern as a result 

of exposure to isobutane in food and 

water or from residential exposure. 

Residues of concern are not anticipated 

for dietary exposure (food and drinking 

water) or for residential exposure 

(dermal and inhalation) from the use of 

isobutane as an inert ingredient in 

pesticide products. As discussed above, 

EPA expects aggregate exposure to 

isobutane to pose no appreciable dietary 

risk given that the data show a lack of 

any systemic toxicity at doses up to 

1,867 mg/kg/day and a lack of any 

apparent developmental effects. 

Taking into consideration all available 

information on isobutane, EPA has 

determined that there is a reasonable 

certainty that no harm to any population 

subgroup, including infants and 

children, will result from aggregate 

exposure to isobutane under reasonable 

foreseeable circumstances. Therefore, 

the establishment of an exemption from 

tolerance under 40 CFR 180.910 for 

residues of isobutane when used as an 

inert ingredient in pesticide 

formulations applied pre- and postharvest and under 40 CFR 180.930 for 

residues of isobutane when used as an 

inert ingredient in pesticide 

formulations applied to animals, is safe 

under FFDCA section 408. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

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

The Codex Alimentarius is a joint 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 isobutane. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 and 40 CFR 

180.930 for isobutane (CAS Reg. No. 75– 

28–5) when used as an inert ingredient 

(propellant) in pesticide formulations 

applied pre- and post-harvest and when 

applied to animals. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

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 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 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) (Pub. L. 

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). 

VIII. 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, 


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Federal Register / Vol. 76, No. 22 / Wednesday, February 2, 2011 / Rules and Regulations 5691 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: January 24, 2011. 

Lois Rossi, 

Director, Registration Division, Office of 

Pesticide Programs. 

Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In the table to § 180.910 add 

alphabetically a new inert ingredient to 

read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Isobutane (CAS Reg. No. 75–28–5) ....................................................................... None ...................... Propellant. 

* * * * * * * 

■ 3. In the table to § 180.930, add 

alphabetically a new inert ingredient to 

read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Isobutane (CAS Reg. No. 75–28–5) ....................................................................... None ...................... Propellant. 

* * * * * * * 

[FR Doc. 2011–2265 Filed 2–1–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0385; FRL–8860–3] 

Cyprodinil; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation amends 

tolerances for residues of cyprodinil in 

or on fruit, pome, group 11 and apple 

wet pomace. This regulation also 

establishes tolerances for meat 

byproducts of cattle, goats, horses and 

sheep. Syngenta Crop Protection 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 2, 2011. Objections and 

requests for hearings must be received 

on or before April 4, 2011, 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–2010–0385. 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 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: Lisa 

Jones, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9424; e-mail address: 

jones.lisa@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 those engaged in the 

following activities: 

• 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 to provide 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. 


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