Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 44811 

EPA lacks the discretionary authority 

to address environmental justice in this 

rulemaking. 

K. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as added by the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, 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 the rule in 

the Federal Register. A major rule 

cannot take effect until 60 days after it 

is published in the Federal Register. 

This action is not a ‘‘major rule’’ as 

defined by 5 U.S.C. section 804(2). This 

rule will be effective on August 26, 

2011. 

L. Petitions for Judicial Review 

Under section 307(b)(1) of the Clean 

Air Act, petitions for judicial review of 

this action must be filed in the United 

States Court of Appeals for the 

appropriate circuit by September 26, 

2011. Filing a petition for 

reconsideration by the Administrator of 

this final rule does not affect the finality 

of this rule for the purposes of judicial 

review nor does it extend the time 

within which a petition for judicial 

review may be filed, and shall not 

postpone the effectiveness of such rule 

or action. This action may not be 

challenged later in proceedings to 

enforce its requirements (see section 

307(b)(2)). 

List of Subjects in 40 CFR Part 52 

Environmental protection, Air 

pollution control, Incorporation by 

reference, Intergovernmental relations, 

Nitrogen dioxide, Ozone, Particulate 

matter, Reporting and recordkeeping 

requirements, Volatile organic 

compounds. 

Dated: June 30, 2011. 

Jared Blumenfeld, 

Regional Administrator, Region IX. 

Part 52, Chapter I, Title 40 of the Code 

of Federal Regulations is amended as 

follows: 

PART 52—[AMENDED] 

■ 1. The authority citation for Part 52 

continues to read as follows: 

Authority: 42 U.S.C. 7401 et seq. 

Subpart F—California 

■ 2. Section 52.220 is amended by 

adding paragraphs (c)(381)(i)(E) and (F) 

to read as follows: 

§ 52.220 Identification of plan. 

* * * * * 

(c) * * * 

(381) * * * 

(i) * * * 

(E) Placer County Air Pollution 

Control District. 

(1) Rule 502, ‘‘New Source Review,’’ 

as adopted on February 11, 2010. 

(F) Feather River Air Quality 

Management District. 

(1) Rule 10.1, ‘‘New Source Review,’’ 

as amended on October 5, 2009, except 

section C, as adopted on February 8, 

1993. 

* * * * * 

[FR Doc. 2011–18834 Filed 7–26–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–0531; FRL–8880–5] 

Carboxymethyl Guar Gum Sodium Salt 

and Carboxymethyl-Hydroxypropyl 

Guar; 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 carboxymethyl 

guar gum sodium salt (CAS Reg. No. 

39346–76–4) and carboxymethylhydroxypropyl guar (CAS Reg. No. 

68130–15–4); when used as an inert 

ingredient (thicker/drift reduction 

agent) in pesticide formulations applied 

to growing crops. SciReg Inc., on behalf 

of Rhodia 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 carboxymethyl guar gum 

sodium salt and carboxymethylhydroxypropyl guar. 

DATES: This regulation is effective July 

27, 2011. Objections and requests for 

hearings must be received on or before 

September 26, 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–2011–0531 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: 

Alganesh Debesai, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8353; e-mail address: 

debesai.alganesh@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. 

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44812 Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 

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:// 

ecfr.gpoaccess.gov/cgi/t/text/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. 

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–2011–0531 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before September 26, 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–2011–0531, 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 February 4, 

2011 (76 FR 6467) (FRL–8858–7), EPA 

issued a notice pursuant to section 408 

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

the filing of a pesticide petitions (PP 

0E7784) under docket ID number EPA– 

HQ–OPP–2010–0878 and (PP 0E7803) 

under docket ID number EPA–HQ– 

OPP–2010–1019 by SciReg Inc., on 

behalf of Rhodia Inc., 12733 Director’s 

Loop, Woodbridge VA 22192. The 

petitions requested that 40 CFR 180.920 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of carboxymethyl 

guar gum sodium salt (CAS Reg. No. 

39346–76–4) and carboxymethylhydroxypropyl guar (CAS Reg. No. 

68130–15–4); when used as an inert 

ingredients (thicker/drift reduction 

agent) in pesticide formulations applied 

to growing crops. Those notices 

referenced a summary of the petitions 

prepared by SciReg Inc., on behalf of 

Rhodia Inc., the petitioner, which is 

available in the docket, http:// 

www.regulations.gov. Comments were 

received on both notices of filing. EPA’s 

response to these comments is 

discussed in Unit V.C. 

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 of carboxymethyl 

guar gum sodium and carboxymethylhydroxypropyl guar including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with carboxymethyl guar 

gum sodium and carboxymethylhydroxypropyl guar 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. Specific 

information on the studies received and 

the nature of the adverse effects caused 

by carboxymethyl guar gum sodium and 

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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 44813 

carboxymethyl-hydroxypropyl guar as 

well as the no-observed-adverse-effectlevel (NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies are discussed in this 

unit. 

The following provides a brief 

summary for the risk assessment and 

conclusions for the Agency’s review for 

the guar gums, which include 

carboxymethyl guar gum sodium and 

carboxymethyl-hydroxypropyl guar. The 

Agency’s full decision document for this 

action is available in the Agency’s 

electronic docket (regulations.gov) 

under the docket number EPA–HQ– 

OPP–2011–0531. Based upon the 

structural similarities between 

carboxymethyl guar gum, 

carboxymethyl-hydroxypropyl guar, 

guar gum, and hydroxypropyl guar, the 

risk assessment for carboxymethyl guar 

and carboxymethyl-hydroxypropyl guar 

relies upon available data on all four 

substances. 

Acute oral toxicity studies conducted 

with guar, hydroxypropyl guar, and 

carboxymethyl guar resulted in oral 

LD50 values ranging from 7,060 

milligrams per kilogram of body weight 

(mg/kg bw) to 17,800 mg/kg bw. Dermal 

irritation studies conducted with guar, 

hydroxypropyl guar, and carboxymethyl 

guar resulted in no irritation to slight 

irritation. Eye irritation studies 

conducted with guar, hydroxypropyl 

guar, and carboxymethyl-hydroxypropyl 

guar demonstrated a range of results 

from non-irritation to severe irritation. 

Results of skin sensitization and 

mutagenicity studies performed with 

guar gum, hydroxypropyl guar, and 

carboxymethyl-hydroxypropyl guar 

were all negative. There are three 90-day 

toxicity studies available for guar gums. 

In one study, the LOAEL of guar gum in 

a diet was 1% (equivalent to 580 mg/kg/ 

day) based on effects on body weight 

gains, and dose related decrease in 

kidney weights. The NOAEL was not 

established in this study. In the second 

study, no effects were observed in male 

rats at doses up to 6% (equivalent to 

3,000 mg/kg/day). In the third study in 

rats, decreased in body weight gains, 

decreased in food efficiency, increased 

in blood urea nitrogen and thyroid 

toxicity (males only) were observed at a 

dietary concentration of 2 and 5%. The 

NOAEL in this study was 1% 

(equivalent to 500 mg/kg/day). No 

adverse effects were reported in dogs 

that were fed 0, 1, 5, or 10% 

(approximately 0, 250, 1,250, or 2,500 

mg/kg/day) of a precooked mixture of 

guar and carob bean for 30 weeks. No 

effects were observed in monkeys that 

were fed 1 gram (equal to 10 mg/kg/day) 

of guar flour for 2 months. 

Teratogenicity studies with guar gum in 

mice, rats, and hamsters did not 

indicate that guar gum is a teratogen; in 

mice at doses up to 800 mg/kg/day, in 

rats up to 900 mg/kg/day and in 

hamsters up to 600 mg/kg/day. Male 

and female Osborne-Mendel rats were 

fed guar gum at 0, 1, 2, 4, 7. 5, or 15% 

(approximately 0, 500, 1,000, 2,000, 

3,750 or 7,500 mg/kg/day) in the diet for 

13 weeks before mating, during mating, 

and throughout gestation. No effects on 

parental fertility, fetal development, sex 

distribution, and no malformations of 

the pups were observed. The NOAEL for 

parental, developmental and 

reproductive toxicity is 7,500 mg/kg/ 

day. No evidence of carcinogenicity was 

found in male and female F344 rats and 

B6C3F1 mice administered diets 

containing 25,000 or 50,000 ppm 

(approximately 3,570 or 7,140 mg/kg/ 

day) guar gum for 103 weeks. A 

reduction in the mean body weight of 

the higher dose females and of the feed 

consumption was observed, as 

compared with the controls. No 

compound-related clinical signs of 

adverse effects on survival were 

observed. There was no increase in the 

incidence of tumors that could be 

related to the test substance. 

Subchronic, reproductive and 

developmental, and carcinogenicity 

studies with guar gum showed no long 

term, reproductive/developmental, or 

carcinogenic effects. Overall, a low 

toxicity profile is expected with both 

carboxymethyl guar and carboxymethylhydroxypropyl guar because of 

likelihood of low absorption via any 

route of exposure due to their high 

molecular weights. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Majority of the available studies 

suggest that high levels of guars were 

well tolerated by laboratory animals. In 

the two 90-day toxicity studies, the 

body weight gains appears to be 

depressed at 500 mg/kg/day dose levels 

and above, however, generally the food 

consumption was not affected, 

indicating low food conversion 

efficiency. In a third 90-day toxicity 

study in rats, no effect on body weight 

was observed at doses up to 3,000 mg/ 

kg/day. No effect on the body weights 

were observed in the reproduction study 

in rats at doses up to 7,500 mg/kg/day. 

In the carcinogenicity studies in mice 

and rats by National Toxicology 

Program (NTP) (1982), no adverse 

effects were observed at doses up to 

3,570 mg/kg/day. Based on their large 

molecular weights, these two chemicals 

are not expected to be significantly 

absorbed via oral, dermal and inhalation 

routes of exposure. This is further 

supported by the animal toxicity studies 

where no significant effects were 

observed in a carcinogenicity studies in 

mice and rats and reproduction study in 

rats at doses up to and including 3,500 

mg/kg/day. Based on the above weight 

of evidence, no endpoint of concern was 

identified, therefore, the Agency has 

determined that a qualitative assessment 

for all pathways of human exposure to 

both carboxymethyl guar and 

carboxymethyl-hydroxypropyl guar 

(food, drinking water, and residential) is 

appropriate. 

C. Aggregate Exposure 

In examining aggregate exposure, the 

Federal Food, Drug, And Cosmetic Act 

(FFDCA) section 408 directs EPA to 

consider available information 

concerning exposures from the pesticide 

residues 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 outdoor uses). 

There are no residential uses proposed 

at this time. No quantification of 

aggregate exposure was performed 

because no end point of concern was 

identified in the available toxicity 

studies. 

1. Dietary and non-dietary exposure. 

Carboxymethyl guar and 

carboxymethyl-hydroxypropyl guar are 

slightly modified forms of guar gum, a 

natural polymer which is an affirmed 

GRAS substance of low toxicity. 

Carboxymethyl guar and 

carboxymethyl-hydroxypropyl guar are 

also structurally similar to 

hydroxypropyl guar, another slightly 

modified form of guar gum. EPA 

reassessed the tolerance exemption for 

hydroxypropyl guar in 2005 and 

concluded that there is a reasonable 

certainty of no harm to any population 

subgroup that will result from aggregate 

exposure to hydroxypropyl guar when 

considering dietary exposure and all 

other nonoccupational sources of 

pesticide exposure for which there is 

reliable information. Based on their 

close structural relationship to guar gum 

and hydroxypropyl guar, as well as their 

high molecular weights and likelihood 

of low absorption via any route of 

exposure, both carboxymethyl guar and 

carboxymethyl-hydroxypropyl guar can 

also be considered to be low toxicity 

substances with a reasonable certainty 

of no harm from dietary exposure and 

all other nonoccupational sources of 

exposure. 

2. Cumulative effects from substances 

with a common mechanism of toxicity. 

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

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44814 Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 

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.’’ 

Carboxymethyl guar and 

carboxymethyl-hydroxypropyl guar are 

slightly modified form of guar gum, a 

natural polymer that has been affirmed 

as generally recognized as safe (GRAS) 

substance of low toxicity. 

Carboxymethyl guar and 

carboxymethyl-hydroxypropyl guar are 

also structurally similar to 

hydroxypropyl guar, another slightly 

modified form of guar gum. They all 

have same toxicity pattern but the exact 

mode of action is not known. Therefore, 

cumulative risk assessment was not 

conducted. 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 

Food Quality Protection Act (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. 

Carboxymethyl guar and 

carboxymethyl-hydroxypropyl guar are 

slight modified forms of guar gum, a 

natural polymer which is an affirmed 

GRAS substance of low toxicity. 

Carboxymethyl guar and 

carboxymethyl-hydroxypropyl guar gum 

are also structurally similar to 

hydroxypopyl guar, another slightly 

modified form guar gum. According to 

EPA’s 2005 tolerance exemption 

reassessment document for 

hydroxypropyl guar, it was concluded 

that hydroxypropyl guar is a high 

molecular weight polymer that is devoid 

of reactive functional groups and which 

is not absorbed by any route of human 

exposure. Also teratogenicity studies 

with guar gum in mice, rats, and 

hamsters did not indicate that guar gum 

is a teratogen; in mice at doses up to 800 

mg/kg/day, in rat up to 900 mg/kg/day 

and in hamsters up to 600 mg/kg/day. 

In addition, no effects on parental 

fertility, fetal development, sex 

distribution, and no malformations of 

the pups were observed at doses up to 

7,500 mg/kg/day in the one generation 

reproduction study in rats. Based on the 

structural similarities to guar gum and 

hydroxyporpyl guar, as well as their 

high molecular weights and low 

likelihood of absorption via any route of 

exposure, carboxymethyl guar and 

carboxymethyl-hydroxypropyl guar are 

unlikely to elicit a toxic response in 

infants and children when used as an 

inert ingredient in pesticide products. 

Available toxicity studies confirm this 

belief and indicate low toxicity; 

therefore, the Agency did not use a 

safety factor analysis for assessing risk 

and no additional safety factor is needed 

for assessing risk to infants and 

children. 

E. Aggregate Risks and Determination of 

Safety 

EPA expects aggregate exposure to 

carboxymethyl guar gum sodium salt 

and carboxymethyl-hydroxypropyl guar 

residues to pose no appreciable risk to 

human health given that they both are 

a polymer with high molecular weight 

that are devoid of reactive functional 

groups and which are not absorbed by 

any route of human exposure. Taking 

into consideration all available 

information on carboxymethyl guar gum 

sodium salt and carboxymethylhydroxypropyl guar, 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 carboxymethyl guar gum 

sodium salt and carboxymethylhydroxypropyl guar under reasonably 

foreseeable circumstances. Therefore, 

the establishment of an exemption from 

a tolerance under 40 CFR 180. 920 for 

residues of carboxymethyl guar gum 

sodium salt and carboxymethylhydroxypropyl guar when used as inert 

ingredients in pesticide formulations 

applied to growing crops under 40 CFR 

180.920 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 not establishing a numerical 

tolerance for residue of carboxymethyl 

guar gum sodium salt and 

carboxymethyl-hydroxypropyl guar in 

or on any food commodities. 

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 carboxymethyl guar gum sodium salt 

and carboxymethyl-hydroxypropyl guar. 

C. Response to Comments 

Two comments, one for each notice of 

filing were received from private 

citizens who opposed the authorization 

to sell any pesticide that leaves a 

residue on food. The Agency 

understands the commenter’s concerns 

and recognizes that some individuals 

believe that no residue of pesticides 

should be allowed. However, under the 

existing legal framework provided by 

section 408 of the Federal Food, Drug 

and Cosmetic Act (FFDCA) EPA is 

authorized to establish pesticide 

tolerances or exemptions where persons 

seeking such tolerances or exemptions 

have demonstrated that the pesticide 

meets the safety standard imposed by 

the statute. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for 

carboxymethyl guar gum sodium salt 

(CAS Reg. No. 39346–76–4) and 

carboxymethyl-hydroxypropyl guar 

(CAS Reg. No. 68130–15–4); when used 

as an inert ingredient (thicker/drift 

reduction agent) in pesticide 

formulations applied to growing crops 

under 40 CFR 180.920. 

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 

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Federal Register / Vol. 76, No. 144 / Wednesday, July 27, 2011 / Rules and Regulations 44815 

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, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: July 12, 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 § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920. Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

Carboxymethyl guar gum sodium salt (CAS Reg. No. 39346–76–4) .............. Without limitation ................ Thicker/drift reduction agent. 

*******

Carboxymethyl-hydroxypropyl guar (CAS Reg. No. 68130–15–4) .................. Without limitation ................ Thicker/drift reduction agent. 

*******

[FR Doc. 2011–18588 Filed 7–26–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0888; FRL–8875–5] 

Chlorantraniliprole; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of 

chlorantraniliprole in or on multiple 

commodities which are identified and 

discussed later in this document. This 

regulation additionally amends 

previously established tolerances in or 

on multiple commodities and deletes 

tolerances in or on several commodities 

that will be superceded by inclusion in 

crop group tolerances. E. I. du Pont de 

Nemours and Company, DuPont Crop 

Protection, requested these tolerances 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA). 

DATES: This regulation is effective July 

27, 2011. Objections and requests for 

hearings must be received on or before 

September 26, 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–2010–0888. 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, 

mstockstill on DSK4VPTVN1PROD with RULES