25236 Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Rules and Regulations 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–1077; FRL–8873–1] 

Carbon Dioxide; 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 carbon dioxide 

(CAS Reg. No. 124–38–9) when used as 

an inert ingredient as a propellant in 

pre-harvest and post-harvest 

applications and when applied to 

animals. Whitmire Micro-Gen Research 

Laboratories, Inc., c/o Landis 

International, Inc. 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 carbon dioxide. 

DATES: This regulation is effective May 

4, 2011. Objections and requests for 

hearings must be received on or before 

July 5, 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–2007–1077. 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: P. V. 

Shah, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–1846; e-mail address: 

shah.pv@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, 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–2007–1077 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 July 5, 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 78, 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–2007–1077, 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 December 

22, 2010 (75 FR 80489) (FRL–8857–8), 

EPA issued a notice pursuant to section 

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

announcing the filing of a pesticide 

petition (PP 0E7811) by Whitmire 

Micro-Gen Research Laboratories, Inc., 

c/o Landis International, Inc., 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 carbon dioxide (CAS Reg. No. 124– 

38–9) when used as an inert ingredient 

as a propellant in pesticide formulations 

applied pre–harvest and post–harvest 

under 40 CFR 180.910 and applied to 

animals under 40 CFR 180.930. That 

notice referenced a summary of the 

petition prepared by Whitmire MicroGen Research Laboratories, Inc., c/o 

Landis International, Inc., the petitioner, 

which is available in the docket, 

http://www.regulations.gov. (Docket ID 

number EPA–HQ–OPP–2007–1077). 

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 

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Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Rules and Regulations 25237 

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 carbon dioxide 

including exposure resulting from the 

exemption established by this action. 

EPA’s assessment of exposures and risks 

associated with carbon dioxide follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data for carbon dioxide 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. The 

primary sources of data for this 

assessment are the U.S. EPA’s 1991, 

Reregistration Eligibility Decision 

document (RED) that included carbon 

dioxide (US EPA RED, 1991), and the 

Report of the FQPA Tolerance 

Reassessment Progress and Risk 

Management Decision (TRED) for 

Carbon Dioxide issued by EPA in 2004. 

The Agency has not found any more 

recent information that would change 

the conclusions found in these 

documents. Therefore, these documents 

are being used to evaluate the proposed 

exemption from the requirement of a 

tolerance for use as an inert ingredient 

as a propellant applied pre-harvest and 

post-harvest under 40 CFR 180.910 and 

applied to animals under 40 CFR 

180.930. Specific information on the 

studies received and the nature of the 

adverse effects caused by carbon 

dioxide can be found in these 

documents at http:// 

www.regulations.gov, ‘‘Reregristration 

Eligibility Document (RED) for Carbon 

and Carbon Dioxide’’, ‘‘Lower Risk 

Pesticide Chemical Focus Group’s 

Assessment for Carbon Dioxide 

Tolerance Reassessment (TRED)’’, and 

‘‘PC code 800029; Decision Document 

for Pesticide Petition 0E7811; Carbon 

Dioxide (CAS Reg. No. 124–38–9) for 

Use as an Inert Ingredient as a 

Propellant Applied Pre-Harvest and 

Post-Harvest Under 40 CFR 180.910 and 

For Use on Animals Under 40 CFR 

180.930.’’ found in docket ID number 

EPA–HQ–OPP–2007–1077. 

The toxicology data for carbon 

dioxide are all derived from inhalation 

studies using high concentrations of 

carbon dioxide. Although these data 

show carbon dioxide does pose some 

hazard at concentrations well above 

normal atmospheric levels, these data 

have limited relevance to evaluating the 

safety of carbon dioxide residues in 

food. Because it is a gas, carbon dioxide 

would be expected to leave little or no 

residues on plant commodities, and, to 

the extent carbon dioxide is absorbed by 

the plant, it would likely be converted 

by the photosynthesis process into 

sugars and other organic compounds 

that are not of toxicological concern. 

In evaluating the human toxicity of 

carbon dioxide, it is relevant to consider 

that ‘‘carbon dioxide is produced by the 

body’s metabolism and is always 

present in the body at about 6 percent 

concentration. An average adult human 

will produce more than 500g of carbon 

dioxide daily under resting conditions, 

and will produce much more when 

active.’’ (US EPA RED, 1991). It is on 

this basis that the Food and Drug 

Administration has classified carbon 

dioxide as Generally Recognized As 

Safe (21 CFR 184.1240) as a direct food 

additive. As the discussion in Unit IV.D. 

on exposure reveals, even worst case 

theoretical levels of carbon dioxide 

residues in food would be dwarfed by 

normal body levels of carbon dioxide. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Considering its presence in the 

environment and in the human body, 

the additional toxicological contribution 

of carbon dioxide through the proposed 

use is expected to be minimal. 

Therefore, the Agency has determined 

that a qualitative assessment for all 

pathways of human exposure to carbon 

dioxide (food, drinking water, and 

residential) is appropriate. 

C. Aggregate Exposures 

1. Dietary exposures (from food and 

drinking water). In evaluating dietary 

exposure to carbon dioxide, EPA 

considered exposure under the 

proposed exemption from the 

requirement of a tolerance. EPA 

assessed dietary exposures from carbon 

dioxide in food and drinking water as 

follows: 

No residue data were submitted for 

carbon dioxide; however, carbon 

dioxide is not expected to accumulate in 

treated raw agricultural commodities, 

rather, it will diffuse into the 

atmosphere following application due to 

its physical and chemical properties. In 

the absence of reliable data regarding 

dietary exposures to carbon dioxide, the 

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25238 Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Rules and Regulations 

Agency assessed dietary exposure using 

its highly conservative Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM–FCID TM, Version 2.03). This 

approach uses surrogate information to 

derive upper bound exposure estimates 

for the subject inert ingredient. Upper 

bound exposure estimates are based on 

the highest tolerance for a given 

commodity from a list of high-use 

insecticides, herbicides, and fungicides. 

A complete description of the general 

approach taken to assess inert 

ingredient risks in the absence of 

residue data is contained in the 

memorandum entitled ‘‘Alkyl Amines 

Polyalkoxylates (Cluster 4): Acute and 

Chronic Aggregate (Food and Drinking 

Water) Dietary Exposure and Risk 

Assessments for the Inerts.’’ (D361707, 

S. Piper, 2/25/09) and can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2008–0738. 

The Agency believes the assumptions 

used to estimate dietary exposures led 

to an extremely conservative assessment 

of dietary risk due to a series of 

compounded conservatisms. For 

example, the model assumes that the 

inert ingredients are used on all 

commodities and that residues will be 

present for every consumed commodity 

at the highest tolerance level residue for 

all food forms (including meat, milk, 

poultry, and eggs), using default 

processing factors for dried 

commodities and assuming that 100% 

of all crops are ‘‘treated’’ with the inert 

ingredient. In addition, a default 

concentration of 100 parts per billion 

(ppb) was assumed for the inert 

ingredient residues in drinking water. 

Accordingly, although sufficient 

information to quantify actual residue 

levels in food is not available, the 

compounding of these conservative 

assumptions will lead to a significant 

exaggeration of actual exposures. EPA 

does not believe that this approach 

underestimates exposure in the absence 

of residue data. Even with the extremely 

conservative nature of this screening 

level model, the estimated dietary (food 

and drinking water) exposures from 

carbon dioxide when used in pesticide 

formulations are 10,000 fold less than 

the amount of carbon dioxide naturally 

produced by the human body each day. 

2. Non-dietary exposure. The term 

‘‘residential exposure’’ is used in this 

document to refer to non-occupational, 

non-dietary exposure (e.g., textiles 

(clothing and diapers), carpets, 

swimming pools, and hard surface 

disinfection on walls, floors, tables). 

Obviously, humans are exposed through 

respiration to carbon dioxide in the 

atmosphere. Dietary exposure from 

naturally-carbonated and artificiallycarbonated beverages is also ubiquitous. 

The discussion in this Unit focuses on 

additional exposures from use of carbon 

dioxide as a propellant in pesticide 

products. 

i. Dermal exposure. In evaluating the 

potential for exposure from the use of 

carbon dioxide in residential pesticide 

products, dermal exposures of concern 

are not anticipated due to its physical 

and chemical properties and dissipating 

nature. 

ii. Inhalation exposures. Inhalation is 

the primary route of exposure from 

carbon dioxide because of its high vapor 

pressure. Because of the potential 

increased risk to acute inhalation 

exposure from indoor uses, EPA used its 

conservative Exposure and Fate 

Assessment Screening Tool (E–FAST 

v.2.0) screening level model to estimate 

the potential for inhalation exposures 

from indoor uses of carbon dioxide as a 

propellant in residential pesticide 

products. E–Fast was developed by 

EPA’s Office of Pollution, Prevention 

and Toxics as a tool to estimate 

concentrations of chemicals released 

from consumer products. Modeled 

estimates of concentrations and doses 

are designed to significantly 

overestimate exposures for use in a 

screening level assessment. For carbon 

dioxide, E–FAST’s aerosol paint 

scenario was selected because it 

potentially resembles a use of a 

residential pesticide product using 

carbon dioxide as a propellant. This 

scenario estimates potential acute 

inhalation exposure over 20 minutes of 

aerosol paint use in an enclosed utility 

room. The Agency considers an acute 

inhalation exposure to be a single event 

occurring over a period of less than 24 

hours. In this case, the E–FAST model 

generated estimates of exposure are 

expected to be greater than what is 

reasonably anticipated from the use of 

carbon dioxide as an inert ingredient in 

residential-use pesticide products. The 

concentration of carbon dioxide in 

aerosol paint products used in the E– 

FAST model was 100%. The results of 

the conservative E–FAST modeling 

show a peak concentration potential of 

4,923 parts per million (ppm) (8,860 

mg/m3). EPA does not expect actual 

exposure from residential use of carbon 

dioxide as a propellant as an inert 

ingredient in pesticide products to 

exceed these modeling estimates (peak 

concentration potential of 4,923 ppm 

(8,860 mg/m3)) and expects that outdoor 

exposure concentrations would also be 

lower. 

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 carbon dioxide to 

share a common mechanism of toxicity 

with any other substances, and carbon 

dioxide does not appear to produce a 

toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that carbon dioxide 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 

In general. Section 408(b)(2)(C) of 

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA Safety Factor (SF). In applying 

this provision, EPA either retains the 

default value of 10X, or uses a different 

additional safety factor when reliable 

data available to EPA support the choice 

of a different factor. 

EPA has not used a quantitative risk 

assessment approach based on safety 

factors for carbon dioxide residues given 

that normal atmospheric levels of 

carbon dioxide do not pose a hazard, 

carbon dioxide is necessary to the 

proper functioning of the human body, 

and exposure to carbon dioxide residues 

from use in pesticide products is 

miniscule compared to existing 

environmental levels. For the same 

reasons, an additional safety factor to 

protect children is not needed. 

E. Aggregate Risks and Determination of 

Safety 

EPA expects aggregate exposure to 

carbon dioxide residues to pose no 

appreciable risk to human health given 

that normal atmospheric levels of 

carbon dioxide do not pose a hazard. 

Carbon dioxide is necessary to the 

proper functioning of the human body, 

and it is unlikely that the use of carbon 

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Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Rules and Regulations 25239 

dioxide as an inert ingredient as a 

propellant in pesticide products will 

result in residues in food that 

measurably add to carbon dioxide 

exposure. Even potential non-dietary 

acute inhalation exposure from indoor 

uses was conducted using the extremely 

conservative E–FAST screening level 

model (described under Unit IV.C.2b), 

showed maximum levels of exposure of 

4,923 ppm, well below the maximum 

permitted exposure limits established as 

safe by Office of Safety Health 

Administration (OSHA) or National 

Institute of Occupational and Health 

(NIOSH) (30,000 ppm). 

Taking into consideration all available 

information on carbon dioxide, 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 carbon dioxide under 

reasonably foreseeable circumstances. 

Therefore, the establishment of an 

exemption from tolerance for residues of 

carbon dioxide (CAS Reg. No. 124–38– 

9) when used as an inert ingredient as 

a propellant in pesticide formulations 

applied pre- and post-harvest under 40 

CFR 180.910 and when applied to 

animals under 40 CFR 180.930 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 carbon dioxide. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.910 and 40 CFR 

180.930 for residues of carbon dioxide 

(CAS Reg. No. 124–38–9) when used as 

an inert ingredient in pesticide 

formulations as a propellant in pre- and 

post-harvest applications under 40 CFR 

180.910 and when applied to animals 

under 40 CFR 180.930. 

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 

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: April 26, 2011. 

G. Jeffrey Herndon, 

Acting 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 § 180.910, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.910 Inert ingredients used preharvest and post-harvest; exemptions from 

the requirement of a tolerance. 

* * * * * 

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25240 Federal Register / Vol. 76, No. 86 / Wednesday, May 4, 2011 / Rules and Regulations 

Inert ingredients Limits Uses 

*******

Carbon Dioxide (CAS Reg. No. 124–38–9) ................................................................... None ................................... Propellant. 

* * * * * * * 

■ 3. In § 180.930, the table is amended 

by adding alphabetically the following 

inert ingredient to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Carbon Dioxide (CAS Reg. No. 124–38–9) ................................................................... None ................................... Propellant. 

* * * * * * * 

[FR Doc. 2011–10889 Filed 5–3–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0771; FRL–8873–3] 

Clothianidin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of clothianidin in 

or on mustard, seed. Bayer CropScience 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective May 

4, 2011. Objections and requests for 

hearings must be received on or before 

July 5, 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–2008–0771. 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: 

Marianne Lewis, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8043; e-mail address: 

lewis.marianne@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. 

B. How can I access electronic copies of 

this document? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

cite at http://www.gpoaccess.gov/ecfr. 

C. Can I file an objection or hearing 

request? 

Under section 408(g) of FFDCA, 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–2008–0771 in the subject line on 

the first page of your submission. All 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

as required by 40 CFR part 178 on or 

before July 5, 2011. 

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 that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit this copy, 

identified by docket ID number EPA– 

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