76200 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations 

cranberry by removing the expiration 

date ‘‘12/31/06’’ and adding in its place 

‘‘12/31/09.’’

§ 180.371 [Amended] 

■ 4. In § 180.371, in the table to 

paragraph (b), amend the entries 

blueberry and citrus by removing the 

expiration date ‘‘6/30/07’’ and adding in 

its place ‘‘12/31/09.’’

§ 180.442 [Amended] 

■ 5. In § 180.442, in the table to 

paragraph (b), amend the entries 

orchardgrass, forage and orchardgrass, 

hay by removing the expiration date ‘‘6/ 

30/07’’ and adding in its place ‘‘12/31/ 

09.’’

§ 180.527 [Amended] 

■ 6. In § 180.527, in the table to 

paragraph (b), amend the entries cattle, 

fat; cattle, kidney; cattle, meat; cattle, 

meat byproducts; goat, fat; goat, kidney; 

goat, meat; goat, meat byproducts; hog, 

fat; hog, kidney; hog, meat; hog, meat 

byproducts; horse, fat; horse, kidney; 

horse, meat; horse, meat byproducts; 

sheep, fat; sheep, kidney; sheep, meat; 

sheep, meat byproducts; wheat, forage; 

wheat, grain; wheat, hay; and wheat, 

straw by removing the expiration date 

‘‘6/30/07’’ and adding in its place ‘‘12/ 

31/09.’’

§ 180.561 [Amended] 

■ 7. In § 180.561, in the table to 

paragraph (b), amend the entries onion, 

dry bulb and onion, green by removing 

the expiration date ‘‘6/30/07’’ and 

adding in its place ‘‘12/31/09.’’

§ 180.567 [Amended] 

■ 8. In § 180.567, in the table to 

paragraph (b), amend the entry ginseng 

by removing the expiration date ‘‘12/31/ 

06’’ and adding in its place ‘‘12/31/09.’’

[FR Doc. E6–21506 Filed 12–19–06; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0536; FRL–8107–7] 

Fluroxypyr; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for combined residues of 

fluroxypyr in or on onion, bulb; garlic, 

bulb; and shallot, bulb. The 

Interregional Research Project Number 4 

(IR–4) requested these tolerances under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA). 

DATES: This regulation is effective 

December 20, 2006. Objections and 

requests for hearings must be received 

on or before February 20, 2007, 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–2005–0536. All documents in the 

docket are listed in the index for the 

docket. 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 

Building), 2777 S. Crystal Drive, 

Arlington, VA. The Docket Facility is 

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

through Friday, excluding legal 

holidays. The Docket telephone number 

is (703) 305–5805. 

FOR FURTHER INFORMATION CONTACT: 

Shaja R. Brothers, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

703–308–3194; e-mail address: 

brothers.shaja@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 111), e.g., 

agricultural workers; greenhouse, 

nursery, and floriculture workers; 

farmers. 

• Animal production (NAICS 112), 

e.g., cattle ranchers and farmers, dairy 

cattle farmers, livestock farmers. 

• Food manufacturing (NAICS 311), 

e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

32532), e.g., agricultural workers; 

commercial applicators; farmers; 

greenhouse, nursery, and floriculture 

workers; residential users. 

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 Access Electronic Copies 

of This Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov., you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

http://www.epa.gov/fedrgstr. You may 

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the FFDCA, as 

amended by the FQPA, any person may 

file an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

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–2005–0536 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 

on or before February 20, 2007. 

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 your 

copies, identified by Docket ID number 

EPA–HQ–OPP–2005–0536, by one of 

the following methods: 


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Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations 76201 

• 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 Building), 2777 S. 

Crystal Drive, Arlington, VA. Deliveries 

are only accepted during the Docket’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 telephone number is (703) 305–

5805. 

II. Background and Statutory Findings 

In the Federal Register of April 21, 

2006 (71 FR 20661) (FRL–8065–1), EPA 

issued a notice pursuant to section 

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

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

pesticide petition (PP 3E6775) by IR–4, 

500 College Road East, Suite 201 West, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.535 be 

amended by establishing tolerances for 

combined residues of the herbicide 

fluroxypyr, 1-methylheptyl ester [1- 

methylheptyl ((4-amino-3,5-dichloro-6- 

fluoro-2-pyridinyl)oxy)acetate] and its 

metabolite fluroxypyr [((4-amino-3,5- 

dichloro-6-fluoro-2-pyridinyl)oxy)acetic 

acid], in or on garlic and shallot (bulb), 

and onion (dry bulb) at 0.03 parts per 

million (ppm). The notice included a 

summary of the petition prepared by 

Dow AgroSciences, the registrant. 

Comments on the notice of filing were 

received from one private citizen. EPA’s 

response to these comments is 

discussed in Unit IV.C. 

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

allows EPA to establish 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 

4 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 performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of section 408 of the 

FFDCA and a complete description of 

the risk assessment process, see http:// 

www.epa.gov/fedrgstr/EPA–PEST/1997/ 

November/Day-26/p30948.htm. 

III. Aggregate Risk Assessment and 

Determination of Safety 

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

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action. EPA has sufficient data to assess 

the hazards of and to make a 

determination on aggregate exposure, 

consistent with section 408(b)(2) of 

FFDCA, for tolerances for combined 

residues of fluroxypyr on onion, bulb; 

garlic, bulb; and shallot, bulb at 0.03 

ppm. EPA’s assessment of exposures 

and risks associated with establishing 

the tolerances follow. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its 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 toxic effects caused by 

fluroxypyr as well as the no observed 

adverse effect level (NOAEL) and the 

lowest observed adverse effect level 

(LOAEL) from the toxicity studies can 

be found at http://www.regulations.gov. 

Docket ID number EPA–HQ–OPP–2005–

0536, Fluroxypyr Field Corn Human 

Health Risk Assessment, pages 12–15. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the dose at which no adverse 

effects are observed (the NOAEL) from 

the toxicology study identified as 

appropriate for use in risk assessment is 

used to estimate the toxicological level 

of concern (LOC). However, the lowest 

dose at which adverse effects of concern 

are identified (the LOAEL) is sometimes 

used for risk assessment if no NOAEL 

was achieved in the toxicology study 

selected. An uncertainty, factor (UF) is 

applied to reflect uncertainties inherent 

in the extrapolation from laboratory 

animal data to humans and in the 

variations in sensitivity among members 

of the human population as well as 

other unknowns. 

The linear default risk methodology 

(Q*) is the primary method currently 

used by the Agency to quantify nonthreshold hazards such as cancer. The 

Q* approach assumes that any amount 

of exposure will lead to some degree of 

cancer risk, estimates risk in terms of 

the probability of occurrence of 

additional cancer cases. More 

information can be found on the general 

principles EPA uses in risk 

characterization at http://www.epa.gov/ 

pesticides/health/human.htm. 

A summary of the toxicological 

endpoints for fluroxypyr used for 

human risk assessment can be found at 

www.regulations.gov. Docket ID number 

EPA–HQ–OPP–2005–0536, Fluroxypyr 

Field Corn Human Health Risk 

Assessment, page 13; and Fluroxypyr 

Dry Bulb Onion Human Health Risk 

Assessment, pages 17–18. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. Tolerances have been 

established (40 CFR 180.535) for the 

combined residues of fluroxypyr, in or 

on the following raw agricultural 

commodities: Barley, corn, grain, oat, 

sorghum, and wheat. Tolerances are also 

established for cattle, goat, hog, horse, 

sheep, and milk. Additionally, time 

limited tolerances are established in 40 

CFR 180.535(b) in or on corn and onion. 

Risk assessments were conducted by 

EPA to assess dietary exposures from 

fluroxypyr in food as follow: 

i. Acute exposure. There were no 

toxic effects attributable to a single dose. 

An endpoint of concern was not 

identified to quantitate an acute-dietary 

risk to the U.S. general population or to 

the subpopulation females 13–50 years 

old. Therefore, an acute aggregate 

exposure assessment was not 

performed. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the Dietary Exposure 

Evaluation Model software with the 

Food Commodity Intake Database 

(DEEM–FCIDTM), which incorporates 

food consumption data as reported by 

respondents in the USDA 1994–1996 

and 1998 Nationwide Continuing 

Surveys of Food Intake by Individuals 

(CSFII); and accumulated exposure to 

the chemical for each commodity. The 

following assumptions were made for 

the chronic exposure assessment: An 

unrefined, Tier 1 chronic dietaryexposure assessment was conducted for 

all supported fluroxypyr food uses. In 

this assessment, tolerance level residues 


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and 100% crop treated (CT) was 

assumed for all crops included in the 

analysis. The assumptions result in 

highly conservative dietary exposure 

estimates. 

iii. Cancer. A cancer dietary 

assessment was not conducted since 

fluroxypyr has been classified as ‘‘not 

likely’’ to be carcinogenic. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring exposure data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

fluroxypyr in drinking water. Because 

the Agency does not have 

comprehensive monitoring data, 

drinking water concentration estimates 

are made by reliance on simulation or 

modeling taking into account data on 

the physical characteristics of 

fluroxypyr. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

can be found at http://www.epa.gov/ 

oppefed1/models/index.htm. 

Refined (Tier II) surface water 

concentrations were developed for 

fluroxypyr with the Pesticide Root Zone 

Model/Exposure Analysis Modeling 

System (PRZM/EXAMS) model, using 

an index reservoir scenario for the aerial 

application of fluroxypyr on rangeland 

and permanent grass pastures. The 

model assumes that fluroxypyr is 

applied at the maximum label rate (0.5 

lb ae/acre). The estimated annual 

average environmental concentration of 

fluroxypyr in surface water is 3.3 parts 

per billion (ppb). 

For the ground water estimated 

concentration, the Tier I Screening 

Concentration in Ground Water (SCI–

GROW) model predicts that fluroxypyr 

will be found at relatively small 

concentrations when the herbicide is 

applied at the maximum recommended 

application rate of 0.5 lbs ae/acre. The 

estimate is 0.042 ppb (0.042 μg/L). This 

conservative estimate is a default value 

generated by the SCI–GROW model. 

Based on the PRZM/EXAMS and SCI–

GROW models, the estimated 

environmental concentrations (EECs) of 

fluroxypyr for surface water are 

estimated to be 3.3 ppb, and 0.04 ppb 

for ground water. Modeled estimates of 

drinking water concentrations were 

directly entered into the dietary 

exposure model (DEEM–FCIDTM). For 

chronic dietary risk assessment, the 

annual average concentration of 3.3 ppb 

was used to access the contribution to 

drinking water. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). 

Fluroxypyr (VistaTM) is registered for 

application to residential turfgrass and 

recreational sites such as golf courses, 

parks, and sports fields. The proposed 

label does not prohibit homeowners 

from mixing/loading/applying VistaTM. 

Residential handlers may receive 

short-term dermal and inhalation 

exposure to fluroxypyr when mixing, 

loading and applying the formulations. 

Adults and children may be exposed to 

fluroxypyr residues from dermal contact 

with turf during post-application 

activities. Toddlers may also receive 

short and intermediate-term oral 

exposure from incidental ingestion 

during post-application activities. 

In conducting the short and 

intermediate-term aggregate risk 

assessments, the Agency made the 

following conservative assumptions. 

• Incidental oral and inhalation 

exposures for the aggregate residential 

handler scenario included children and 

adults (U.S. population subgroup). 

• Incidental oral exposure from 

treated areas included infants and 

children (up to age 12) for the aggregate 

post-application scenario. 

• Inhalation exposure resulting from 

residential application included youth 

(age 13–19 years old), and the adult 

population subgroups. 

4. Cumulative effects from substances 

with a common mechanism of toxicity. 

Section 408(b)(2)(D)(v) of the 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.’’

Unlike other pesticides for which EPA 

has followed a cumulative risk approach 

based on a common mechanism of 

toxicity, EPA has not made a common 

mechanism of toxicity finding as to 

fluroxypyr and any other substances 

and fluroxypyr does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

not assumed that fluroxypyr has 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 the policy statements 

released by EPA’s Office of Pesticide 

Programs concerning common 

mechanism determinations and 

procedures for cumulating effects from 

substances found to have a common 

mechanism on EPA’s Web site at 

http://www.epa.gov/pesticides/ 

cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional tenfold margin of safety for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure unless EPA 

determines based on reliable data that a 

different margin of safety will be safe for 

infants and children. Margins of safety 

are incorporated into EPA risk 

assessments either directly through use 

of a MOE analysis or through using 

uncertainty (safety) factors in 

calculating a dose level that poses no 

appreciable risk to humans. In applying 

this provision, EPA either retains the 

default value of 10X when reliable data 

do not support the choice of a different 

factor, or, if reliable data are available, 

EPA uses a different additional safety 

factor value based on the use of 

traditional uncertainty factors and/or 

special FQPA safety factors, as 

appropriate. 

2. Prenatal and postnatal sensitivity. 

There was no evidence (quantitative/ 

qualitative) of increased susceptibility 

following in utero exposure to the acid 

and the ester in rats and rabbits, or 

following prenatal and/or postnatal 

exposure to the acid form in rats. 

3. Conclusion. EPA has determined 

that reliable data show that it would be 

safe for infants and children to reduce 

the FQPA safety factor to 1X. That 

decision is based on the following 

findings: 

• The toxicity database for fluroxypyr 

is complete. 

• There was no evidence of 

neurotoxicity or neuropathology in the 

available studies. 

• There was no evidence 

(quantitative/qualitative) of increased 

susceptibility following pre and/or 

postnatal exposure. 

• The chronic dietary food exposure 

assessment utilizes tolerance level 

residue estimates and assumes 100% CT 

for all commodities. This assessment is 

not likely to underestimate exposure/ 

risk. 

• The dietary drinking water 

assessment utilizes water concentration 

values generated by model and 

associated modeling parameters 

designed to provide conservative, health 

protective, high-end estimates of water 

concentrations which will not likely be 

exceeded. 


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• The residential exposure 

assessment was conducted using 

standard assumptions based on 

carefully reviewed data. 

E. Aggregate Risks and Determination of 

Safety 

1. Acute risk. There were no toxic 

effects attributable to a single dose. An 

endpoint of concern was not identified 

for any population subgroup. Therefore, 

fluroxypyr is not expected to pose an 

acute risk. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that exposure to fluroxypyr from food 

and water will utilize <1% of the cPAD 

for the U.S. population, <1% of the 

cPAD for all infants <1 year old, and 

1.4% of the cPAD for children 1–2 years 

old. Based on the use pattern, chronic 

residential exposure to residues of 

fluroxypyr is not expected. 

3. Short and intermediate-term risk. 

Short and intermediate-term aggregate 

exposures are likely to result from 

exposure to fluroxypyr residues from 

food, drinking water, and residential 

pesticide uses. High-end estimates are 

used for residential exposure, while 

average values are used for food and 

drinking water. Short and intermediateterm risk assessments are required for 

adults (residential handler inhalation 

exposure scenario), in addition to 

infants and children (residential postapplication oral exposure scenario). 

Using the exposure assumptions 

described for non-dietary short and 

intermediate-term exposures, EPA has 

concluded that food, water, and 

residential exposures aggregated result 

in aggregate MOEs from 4,400 to 54,000 

(adults 50+ years old). The MOEs are 

8,300 and 4,400 for the U.S. population, 

and children 1–2 years old (the most 

highly exposed subgroup), respectively. 

4. Aggregate cancer risk for U.S. 

population. Fluroxypyr has been 

classified as ‘‘not likely’’ to be 

carcinogenic. Therefore, fluroxypyr is 

not expected to pose a cancer risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, and to infants and children 

from aggregate exposure to fluroxypyr 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The gas chromatography/massselective detector (GC/MSD) analytical 

method used to determine residues of 

fluroxypyr in both the acid and 

methylheptyl ester forms is adequate to 

recover residues of fluroxypyr and 

fluroxypyr 1–MHE in dry bulb onions. 

The method converts the methylheptyl 

ester form of fluroxypyr to the acid and 

results are reported as the acid 

equivalent. The lower limit of method 

validation (LLMV) for bulb onions was 

0.01 ppm. Further, the method is an 

adaptation of a Dow 

AgroSciencesmethod GRM 96.02, which 

has been adequately validated as an 

enforcement method; therefore the 

Agency considers the modified method 

to be adequate to enforce the requested 

tolerance. 

Adequate enforcement methodology 

(GC/MSD) is available to enforce the 

tolerance expression. The method may 

be requested from: Chief, Analytical 

Chemistry Branch, Environmental 

Science Center, 701 Mapes Rd., Ft. 

Meade, MD 20755–5350; telephone 

number: (410) 305–2905; e-mail address: 

residuemethods@epa.gov. 

B. International Residue Limits 

There are currently no Codex, 

Canadian, or Mexican maximum residue 

limits for fluroxypyr or its metabolites 

in/on dry bulb onions. 

C. Response to Comments 

A private citizen of Florham Park, 

New Jersey submitted public comments 

on the fluroxypyr notice of filing. The 

private citizen commented on the 

cancer finding classification ‘‘not likely 

a carcinogen,’’ and views the statement 

deceptive. 

EPA’s response: The cancer 

classification ‘‘Not Likely to be 

Carcinogenic to Humans’’ comes from 

EPA’s Guidelines for Carcinogen Risk 

Assessment. These Guidelines 

recommend this descriptor when the 

available data are considered robust for 

deciding that there is no basis for 

human hazard concern. These 

Guidelines were developed as part of an 

Agency-wide guidelines development 

program by a Technical Panel of the 

U.S. EPA’s Risk Assessment Forum, 

which was composed of scientists from 

throughout the Agency. Selected drafts 

were peer reviewed internally by the 

U.S. EPA’s Science Advisory Board, and 

by experts from universities, 

environmental groups, industry and 

other governmental agencies. The 

Guidelines were also subjected to 

several public comment periods. For 

additional information regarding EPA’s 

Guidelines for Carcinogen Risk and 

recommended descriptor language 

please refer to the Federal Register of 

April 7, 2005 (70 FR 17765) (FRL–7896–

1) (http://www.epa.gov/fedrgstr/EPATOX/2005/April/Day-07/t6642.htm]. 

The private citizen also commented 

on profiteers utilizing the Agency to 

promote poor products to the American 

citizens. 

EPA’s response: This comment is not 

germane to EPA’s statutory basis for 

acting on fluroxypyr tolerance petition. 

Thus, a technical response to this 

comment is not required. The private 

citizen’s comments contained no 

scientific data or other substantive 

evidence to rebut the Agency’s 

conclusion that there is a reasonable 

certainty that no harm will result from 

aggregate exposure to fluroxypyr from 

the establishment of these tolerances. 

V. Conclusion 

Therefore, the tolerances are 

established for combined residues of 

fluroxypyr, 1-methylheptyl ester [1- 

methylheptyl] ((4-amino-3,5-dichloro-6- 

fluoro-2-pyridinyl)oxy)acetate] and its 

metabolite fluroxypyr [((4-amino-3,5- 

dichloro-6-fluoro-2-pyridinyl)oxy)acetic 

acid], in or on onion, bulb; garlic, bulb; 

and shallot, bulb at 0.03 ppm. 

VI. 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 rule has 

been exempted from review under 

Executive Order 12866 due to its lack of 

significance, this rule is not subject to 

Executive Order 13211, Actions 

Concerning Regulations That 

Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001). 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., or 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). 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); or OMB review or any Agency 

action under Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 


rwilkins on PROD1PC63 with RULES
76204 Federal Register / Vol. 71, No. 244 / Wednesday, December 20, 2006 / Rules and Regulations 

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). 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. In addition, the 

Agency has determined that this action 

will not have a substantial direct effect 

on States, on the relationship between 

the national government and the States, 

or on the distribution of power and 

responsibilities among the various 

levels of government, as specified in 

Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999). Executive Order 13132 requires 

EPA to develop an accountable process 

to ensure ‘‘meaningful and timely input 

by State and local officials in the 

development of regulatory policies that 

have federalism implications.’’ ‘‘Policies 

that have federalism implications’’ is 

defined in the Executive order to 

include regulations that have 

‘‘substantial direct effects on the States, 

on the relationship between the national 

government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government.’’ This final rule 

directly regulates growers, food 

processors, food handlers and food 

retailers, not States. This action does not 

alter the relationships or distribution of 

power and responsibilities established 

by Congress in the preemption 

provisions of section 408(n)(4) of 

FFDCA. For these same reasons, the 

Agency has determined that this rule 

does not have any ‘‘tribal implications’’

as described in Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 6, 2000). Executive 

Order 13175, requires EPA to develop 

an accountable process to ensure 

‘‘meaningful and timely input by tribal 

officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ is defined in the 

Executive order to include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the Federal 

Government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the Federal 

Goverument and Indian tribes.’’ This 

rule will not have substantial direct 

effects on tribal governments, on the 

relationship between the Federal 

Government and Indian tribes, or on the 

distribution of power and 

responsibilities between the Federal 

Government and Indian tribes, as 

specified in Executive Order 13175. 

Thus, Executive Order 13175 does not 

apply to this rule. 

VII. 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 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: December 12, 2006. 

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. Section 180.535 is amended by 

alphabetically adding commodities to 

the table in paragraph (a) to read as 

follows: 

§ 180.535 Fluroxypyr 1-methylheptyl ester; 

tolerances for residues. 

(a) * * * 

Commodity Parts per 

million 

* * * * * 

Garlic, bulb ............................... 0.03 

* * * * * 

Onion, bulb ............................... 0.03 

Shallot, bulb .............................. 0.03 

* * * * * 

* * * * * 

[FR Doc. 06–9765 Filed 12–19–06; 8:45 am] 

BILLING CODE 6560–50–M 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 710 

[EPA–HQ–OPPT–2006–0981; FRL–8109–9] 

RIN 2070–AC61 

2006 Reporting Notice and 

Amendment; Partial Updating of TSCA 

Inventory Database; Chemical 

Substance Production, Processing, 

and Use Site Reports 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; Amendment; Notice 

of submission period extension. 

SUMMARY: EPA is amending the Toxic 

Substances Control Act (TSCA) 

Inventory Update Reporting (IUR) 

regulations by extending the submission 

deadline for 2006 reports from 

December 23, 2006 to March 23, 2007. 

This is a one-time extension for the 

2006 submission period only. The IUR 

requires manufacturers and importers of 

certain chemical substances included on 

the TSCA Chemical Substance 

Inventory to report current data on the 

manufacturing, processing, and use of 

the substances. 

DATES: This final rule is effective 

December 20, 2006. The 2006 IUR 

submission period is extended to run 

from December 23, 2006 to March 23, 

2007. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ–

OPPT–2006–0981. All documents in the 

docket are listed on the regulations.gov 

website. 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. The 

EPA Docket Center (EPA/DC) suffered 

structural damage due to flooding in 

June 2006. Although the EPA/DC is 

continuing operations, there will be 

temporary changes to the EPA/DC 

during the clean-up. The EPA/DC Public 

Reading Room, which was temporarily 

closed due to flooding, has been 

relocated in the EPA Headquarters 

Library, Infoterra Room (Rm. 3334) in 

the EPA West Bldg., located at 1301 

Constitution Ave., NW., Washington, 


rwilkins on PROD1PC63 with RULES