1508 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations 

Dated: December 28, 2007. 

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 180.475 is amended by 

revising paragraph (a) to read as follows: 

§ 180.475 Difenoconazole; tolerances for 

residues. 

(a) General. (1) Tolerances are 

established for residues of the fungicide 

difenoconazole, 1-[2-[2-chloro-4-(4- 

chlorophenoxy)phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H-1,2,4-triazole, 

in or on the following commodities: 

Commodity Parts per 

million 

Apple, wet pomace ................... 4.5 

Banana1 .................................... 0.2 

Barley, grain ............................. 0.1 

Barley, hay ................................ 0.05 

Barley, straw ............................. 0.05 

Beet, sugar ............................... 0.01 

Beet, sugar, dried pulp ............. 1.9 

Canola, seed ............................ 0.01 

Corn, sweet, forage .................. 0.01 

Corn, sweet, kernel plus cob 

with husks removed .............. 0.01 

Corn, sweet, stover .................. 0.01 

Cotton, gin byproducts ............. 0.05 

Cotton, undelinted seed ........... 0.05 

Fruit, pome group 11 ................ 1.0 

Grape1 ...................................... 0.10 

Papaya1 .................................... 0.30 

Potato, processed waste .......... 0.04 

Rye, grain1 ................................ 0.1 

Vegetable, fruiting, group 8 ...... 0.60 

Vegetable, tuberous and corm, 

subgroup 1C ......................... 0.01 

1 There are no U.S. registrations. 

(2) Tolerances are established for 

residues of the fungicide 

difenoconazole, 1-[2-[2-chloro-4-(4- 

chlorophenoxy)phenyl]-4-methyl-1,3- 

dioxolan-2-ylmethyl]-1H-1,2,4-triazole, 

and its metabolite, CGA-205375, 1-[2- 

chloro-4-(4-chloro-phenoxy)phenyl]-2- 

[1,2,4]triazol-1-yl-ethanol, in or on the 

following commodities: 

Commodity Parts per 

million 

Cattle, fat .................................. 0.10 

Cattle, liver ................................ 0.20 

Cattle, meat .............................. 0.05 

Cattle, meat byproduct (except 

liver) ...................................... 0.10 

Eggs .......................................... 0.10 

Goat, fat .................................... 0.10 

Goat, liver ................................. 0.20 

Commodity Parts per 

million 

Goat, meat ................................ 0.05 

Goat, meat byproduct (except 

liver) ...................................... 0.10 

Hog, fat ..................................... 0.10 

Hog, liver .................................. 0.20 

Hog, meat ................................. 0.05 

Hog, meat byproduct (except 

liver) ...................................... 0.10 

Horse, fat .................................. 0.10 

Horse, liver ............................... 0.20 

Horse, meat .............................. 0.05 

Horse, meat byproduct (except 

liver) ...................................... 0.10 

Milk ........................................... 0.01 

Sheep, fat ................................. 0.10 

Sheep, liver ............................... 0.20 

Sheep, meat ............................. 0.05 

Sheep, meat byproduct (except 

liver) ...................................... 0.10 

* * * * * 

[FR Doc. E8–15 Filed 1–8–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0093]; FRL–8344–3] 

Mesotrione; Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of mesotrione in 

or on berry, group 13; flax, seed; 

cranberry; lingonberry; millet, grain; 

millet, forage; millet, hay; and millet, 

straw. Syngenta Crop Protection 

requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

January 9, 2008. Objections and requests 

for hearings must be received on or 

before March 10, 2008, 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–2006–0093. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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: 

Kathryn V. Montague, Registration 

Division (7505P), Office of Pesticide 

Programs, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (703) 305–1243; e-mail address: 

montague.kathryn @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), e.g., agricultural workers; 

greenhouse, nursery, and floriculture 

workers; farmers. 

• Animal production (NAICS code 

112), e.g., cattle ranchers and farmers, 

dairy cattle farmers, livestock farmers. 

• Food manufacturing (NAICS code 

311), e.g., agricultural workers; farmers; 

greenhouse, nursery, and floriculture 

workers; ranchers; pesticide applicators. 

• Pesticide manufacturing (NAICS 

code 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 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 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations 1509 

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 EPA’s tolerance 

regulations at 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 FFDCA, 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–2006–0093 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 March 10, 2008. 

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–

HQ–OPP–2006–0093, 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’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 Tolerance 

In the Federal Register of April 26, 

2006 (71 FR 24695) (FRL–8063–7), 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 6F7023) by 

Syngenta Crop Protection, P.O. Box 

18300, Greensboro, NC. The petition 

requested that 40 CFR 180.571 be 

amended by establishing tolerances for 

residues of the herbicide mesotrione, 2–

[4- (methylsulfonyl)-2-nitrobenzoyl]-1,3- 

cyclohexanedione, in or on flax, meal/ 

seed at 0.01 parts per million (ppm); 

millet, forage/grain at 0.01 parts per 

million (ppm); millet, hay/straw at 0.02 

ppm; Berry group and cranberry at 0.01 

ppm. That notice referenced a summary 

of the petition prepared by Syngenta 

Crop Protection, the registrant, which is 

available to the public in the docket, 

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

no comments received in response to 

the notice of filing. 

Based upon review of the data 

supporting the petition, to harmonize 

with the Food and Feed Commodity 

Vocabulary (http://www.epa.gov/ 

opphed01/foodfeed/index.htm) EPA has 

amended the commodity listing to read: 

Flax, seed at 0.01 ppm; millet, grain at 

0.01 ppm; millet, forage at 0.01 ppm; 

millet, hay at 0.02 ppm; millet, straw at 

0.02 ppm; berry, group 13 at 0.01 ppm, 

lingonberry at 0.01 ppm and cranberry 

at 0.02 ppm 

III. Aggregate Risk Assessment and 

Determination of Safety 

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 

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....’’ These provisions 

were added to FFDCA by the Food 

Quality Protection Act (FQPA) of 1996. 

Consistent with FFDCA section 

408(b)(2)(D), and the factors specified in 

FFDCA section 408(b)(2)(D), 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 the petitioned-for 

tolerance for residues of mesotrione on 

flax, seed at 0.01 ppm; millet, grain at 

0.01 ppm; millet, forage at 0.01 ppm; 

millet, hay at 0.02 ppm; millet, straw at 

0.02 ppm; berry group 13 at 0.01 ppm, 

lingonberry at 0.01 ppm and cranberry 

at 0.02 ppm. EPA’s assessment of 

exposures and risks associated with 

establishing the tolerance follows. 

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 adverse effects caused 

by mesotrione as well as the noobserved-adverse-effect-level (NOAEL) 

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

can be found at http:// 

www.regulations.gov. The referenced 

document is available in the docket 

established by this action, which is 

described under ADDRESSES, and is 

identified as ‘‘Mesotrione: Petition 

6F7023 Human Health Risk Assessment 

for Proposed Section 3 New Uses on 

Berries, Cranberries, Millet, Flax, Grain 

Sorghum (Section 18)’’ in that docket. 

Additionally, mesotrione toxicological 

data are discussed in the final rule 

published in the Federal Register of 

June 21, 2001 (66 FR 33187) (FRL–

6787–7). 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, the toxicological level of concern 

(LOC) is derived from the highest dose 

at which no adverse effects are observed 

(the NOAEL) in the toxicology study 

identified as appropriate for use in risk 

assessment. However, if a NOAEL 

cannot be determined, the lowest dose 

at which adverse effects of concern are 

identified (the LOAEL) is sometimes 


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1510 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations 

used for risk assessment. Uncertainty/ 

safety factors (UFs) are used in 

conjunction with the LOC to take into 

account 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. Safety is assessed for acute 

and chronic risks by comparing 

aggregate exposure to the pesticide to 

the acute population adjusted dose 

(aPAD) and chronic population adjusted 

dose (cPAD). The aPAD and cPAD are 

calculated by dividing the LOC by all 

applicable UFs. Short-term, 

intermediate-term, and long-term risks 

are evaluated by comparing aggregate 

exposure to the LOC to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk and 

estimates risk in terms of the probability 

of occurrence of additional adverse 

cases. Generally, cancer risks are 

considered non-threshold. For more 

information on the general principles 

EPA uses in risk characterization and a 

complete description of the risk 

assessment process, see http:// 

www.epa.gov/fedrgstr/EPA-PEST/1997/ 

November/Day–26/p30948.htm. 

A summary of the toxicological 

endpoints for mesotrione used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Mesotrione: Petition 6F7023 Human 

Health Risk Assessment for Proposed 

Section 3 New Uses on Berries, 

Cranberries, Millet, Flax, Grain 

Sorghum (Section 18)’’ at page 16 in 

docket ID number EPA–HQ–OPP–2006–

0093. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to mesotrione, EPA considered 

exposure under the petitioned-for 

tolerances as well as all existing 

mesotrione tolerances in (40 CFR 

180.571). EPA assessed dietary 

exposures from mesotrione in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 

are performed for a food-use pesticide, 

if a toxicological study has indicated the 

possibility of an effect of concern 

occurring as a result of a 1–day or single 

exposure. 

No such effects were identified in the 

toxicological studies for mesotrione; 

therefore, a quantitative acute dietary 

exposure assessment is unnecessary. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used the food consumption data 

from the United States Department of 

Agriculutre (USDA) 1994–1996, and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA assumed 

all foods for which there are tolerances 

were treated and contain tolerance-level 

residues. 

iii. Cancer. Mesotrione was negative 

for carcinogenicity in feeding studies in 

rats and mice and was classified as ‘‘not 

likely’’ to be a human carcinogen. 

Therefore, a quantitative exposure 

assessment to evaluate cancer risk is 

unnecessary. 

2. Dietary exposure from drinking 

water. The Agency lacks sufficient 

monitoring data to complete a 

comprehensive dietary exposure 

analysis and risk assessment for 

mesotrione 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 environmental fate characteristics of 

mesotrione. Further information 

regarding EPA drinking water models 

used in pesticide exposure assessment 

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

oppefed1/models/water/index.htm. 

Based on the First Index Reservoir 

Screening Tool (FIRST) for dry 

harvested cranberry and a modified 

Interim Rice Model for wet harvested 

cranberry and Screening Concentration 

in Ground Water (SCI-GROW) models, 

the estimated environmental 

concentrations (EECs) of mesotrione for 

chronic exposures are estimated to be 

4.7 parts per billion (ppb) for surface 

water and 0.18 ppb for ground water. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. For 

chronic dietary risk assessment, the 

water concentration of value 4.7 ppb 

was used to assess 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). 

Mesotrione is not registered for use on 

any sites that would result in residential 

exposure. 

4. 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.’’

Mesotrione, pyrasulfotole, 

isoxaflutole and topramezone belong to 

a class of herbicides that inhibit the 

liver enzyme 4-hydroxyphenylpyruvate 

dioxygenase (HPPD), which is involved 

in the catabolism (metabolic 

breakdown) of tyrosine (an amino acid 

derived from proteins in the diet). 

Inhibition of HPPD can result in 

elevated tyrosine levels in the blood, a 

condition called tyrosinemia. HPPDinhibiting herbicides have been found to 

cause a number of toxicities in 

laboratory animal studies including 

ocular, developmental, liver and kidney 

effects. Of these toxicities, it is the 

ocular effect (corneal opacity) that is 

highly correlated with the elevated 

blood tyrosine levels. In fact, rats dosed 

with tyrosine alone show ocular 

opacities similar to those seen with 

HPPD inhibitors. Although the other 

toxicities may be associated with 

chemically-induced tyrosinemia, other 

mechanisms may also be involved. 

There are marked differences among 

species in the ocular toxicity associated 

with inhibition of HPPD. Ocular effects 

following treatment with HPPD 

inhibitor herbicides are seen in the rat 

but not in the mouse. Monkeys also 

seem to be recalcitrant to the ocular 

toxicity induced by HPPD inhibition. 

One explanation of this species-specific 

response in ocular opacity may be 

related to the species differences in the 

clearance of tyrosine. A metabolic 

pathway exists to remove tyrosine from 

the blood that involves a liver enzyme 

called tyrosine aminotransferase (TAT). 

In contrast to rats where ocular toxicity 

is observed following exposure to 

HPPD-inhibiting herbicides, mice and 

humans are unlikely to achieve the 

levels of plasma tyrosine necessary to 

produce ocular opacities because the 

activity of TAT in these species is much 

greater compared to rats. HPPD 

inhibitors (e.g., nitisinone) are used as 

an effective therapeutic agent to treat 

patients suffering from rare genetic 

diseases of tyrosine catabolism. 

Treatment starts in childhood but is 

often sustained throughout patient’s 

lifetime. The human experience 

indicates that a therapeutic dose (1 

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

dose) of nitisinone has an excellent 

safety record in infants, children and 

adults and that serious adverse health 

outcomes have not been observed in a 

population followed for approximately a 

decade. Rarely, ocular effects are seen in 

patients with high plasma tyrosine 


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levels; however, these effects are 

transient and can be readily reversed 

upon adherence to a restricted protein 

diet. This indicates that an HPPD 

inhibitor in and of itself cannot easily 

overwhelm the tyrosine-clearance 

mechanism in humans. 

Therefore, exposure to environmental 

residues of HPPD-inhibiting herbicides 

are unlikely to result in the high blood 

levels of tyrosine and ocular toxicity in 

humans due to an efficient metabolic 

process to handle excess tyrosine. The 

Agency continues to study the complex 

relationships between elevated tyrosine 

levels and biological effects in various 

species. Nonetheless, as a worst case 

scenario, EPA has assessed aggregate 

exposure to mesotrione based on ocular 

effects in rats. For similar reasons, a 

semi-quantitative screening cumulative 

assessment was conducted using the rat 

ocular effects and 100% crop treated 

information. The results of this 

screening analysis did not indicate a 

concern. In the future, assessments of 

HPPD-inhibiting herbicides will 

consider more appropriate models and 

cross species extrapolation methods. 

Therefore, EPA has not conducted 

cumulative risk assessment with other 

HPPD inhibitors. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s website at http:// 

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

1. In general. Section 408 of FFDCA 

provides that EPA shall apply an 

additional (‘‘10X’’) tenfold margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database 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. 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 FQPA safety 

factor value based on the use of 

traditional UFs and/or special FQPA 

safety factors, as appropriate. 

2. Prenatal and postnatal sensitivity. 

There is quantitative evidence of 

increased susceptibility of the young in 

the oral prenatal developmental toxicity 

studies in rats, mice, and rabbits and in 

the multi-generation reproduction study 

in mice and lack of a developmental 

neurotoxicity study in mice. 

Quantitative evidence of increased 

susceptibility was not demonstrated in 

the multi-generation reproduction study 

in rats. However, no NOAEL was 

established for parental or offspring 

systemic toxicity. There is evidence of 

a qualitative increase in susceptibility 

since the tyrosinemia observed in the 

young was much more severe than that 

observed in the adults. 

3. Conclusion. There are 2 

deficiencies in the mesotrione toxicity 

database. First, a Developmental 

Neurotoxicity Study has been required 

to assess the effects on the developing 

nervous/ocular system from exposed to 

mesotrione. Second, the mouse 2–

generation reproduction study, on 

which the Reference Dose/ Population 

Adjusted Dose (RfD/PAD) is based failed 

to identify a NOAEL. In light of this data 

gap, the necessity of a reliance on a 

LOAEL to calculate the RfD/PAD, and 

the quantitative and qualitative 

evidence of increased susceptibility of 

the young discussed above, EPA is 

raising the 10X FQPA safety factor to 

the value of 30X. 

E. Aggregate Risks and Determination of 

Safety 

Safety is assessed for acute and 

chronic risks by comparing aggregate 

exposure to the pesticide to the aPAD 

and cPAD. The aPAD and cPAD are 

calculated by dividing the LOC by all 

applicable UFs. For linear cancer risks, 

EPA calculates the probability of 

additional cancer cases given aggregate 

exposure. Short-term, intermediateterm, and long-term risks are evaluated 

by comparing aggregate exposure to the 

LOC to ensure that the MOE called for 

by the product of all applicable UFs is 

not exceeded. 

1. Acute risk. There were no effects 

observed in oral toxicity studies 

including developmental toxicity 

studies in rats and rabbits that could be 

attributable to a single dose (exposure). 

Therefore, mesotrione 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 mesotrione from food 

and water will utilize 51% of the cPAD 

for the population group (All Infants (<1 

year old)). There are no residential uses 

for mesotrione that result in chronic 

residential exposure to mesotrione. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

residential exposure plus chronic 

exposure to food and water (considered 

to be a background exposure level). 

Mesotrione is not registered for use on 

any sites that would result in residential 

exposure. Therefore, the aggregate risk 

is the sum of the risk from food and 

water. 

4. Intermediate-term risk 

Intermediate-term aggregate exposure 

takes into account residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Mesotrione is not registered for use on 

any sites that would result in residential 

exposure. Therefore, the aggregate risk 

is the sum of the risk from food and 

water, which do not exceed the 

Agency’s level of concern. 

5. Aggregate cancer risk for U.S. 

population. Mesotrione is classified as a 

‘‘not likely’’ to be carcinogenic in 

humans based on the results of a 

carcinogenicity study in mice and the 

combined chronic toxicity and 

carcinogenicity study in the rat. 

Therefore, mesotrione is not expected to 

pose a cancer risk to humans. 

6. 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 or to infants and children 

from aggregate exposure to mesotrione 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(high-pressure liquid chromatography 

fluorescence detector (HPLC/FLD)) 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 no CODEX, Canadian, or 

Mexican tolerances/Maximum Residue 

Levels for mesotrione residues for the 

proposed crops. 

V. Conclusion 

Therefore, the tolerance is established 

for residues of mesotrione, 2-[4- 

(methylsulfonyl)-2-nitrobenzoyl]-1,3- 

cyclohexanedione, in or on flax, seed at 

0.01 ppm; millet, grain at 0.01 ppm; 

millet, forage at 0.01 ppm; millet, hay at 

0.02 ppm; millet, straw at 0.02 ppm; 

berry group 13 at 0.01 ppm, lingonberry 

at 0.01 ppm and cranberry at 0.02 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 


pwalker on PROD1PC71 with NOTICES
1512 Federal Register / Vol. 73, No. 6 / Wednesday, January 9, 2008 / Rules and Regulations 

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, 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) 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 6, 2000) do not apply 

to this rule. In addition, This rule does 

not impose any enforceable duty or 

contain any unfunded mandate as 

described under Title II of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

(Public Law 104–4). 

This action does not involve any 

technical standards that would require 

Agency consideration of voluntary 

consensus standards pursuant to section 

12(d) of the National Technology 

Transfer and Advancement Act of 1995 

(NTTAA), Public Law 104–113, section 

12(d) (15 U.S.C. 272 note). 

VII. 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: December 28, 2007. 

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 180.571 is amended by 

alphabetically adding the following 

commodities in the table in paragraph 

(a) to read as follows: 

§ 180.571 Mesotrione; tolerances for 

residues. 

(a) * * * 

Commodity Parts per million 

Berry, group 13 ............... 0.01 

* * * * * 

Cranberry ........................ 0.02 

Flax, seed ....................... 0.01 

Lingonberry ..................... 0.01 

Millet, grain ..................... 0.01 

Millet, forage ................... 0.01 

Millet, hay ....................... 0.02 

Millet, straw ..................... 0.02 

* * * * * 

[FR Doc. E8–181 Filed 1–8–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2005–0268; FRL–8345–8] 

Poly(hexamethylenebiguanide) 

hydrochloride (PHMB); 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 the insecticide, 

Poly(hexamethylenebiguanide) 

hydrochloride (PHMB) on all food when 

residues are the result of lawful 

application of a food contact surface 

sanitizer containing PHMB as a sanitizer 

solution in food handling 

establishments when applied as a 

sanitizer. Arch Chemicals Inc. 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), as amended by the Food 

Quality Protection Act of 1996 (FQPA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of PHMB. 

DATES: This regulation is effective 

January 9, 2008. Objections and requests 

for hearings must be received on or 

before March 10, 2008, 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–2005–0268. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

Search,’’ then ‘‘Docket Search.’’ Insert 

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

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 either in the electronic docket 

at http://www.regulations.gov, or, if only 


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