Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 8261 

Commodity 

Parts 

per 

million 

Expiration/ 

revocation 

date 

Bermuda grass, forage 10 12/31/11 

Bermuda grass, hay ... 25 12/31/11 

* * * * * 

[FR Doc. 2010–3673 Filed 2–23–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0885; FRL–8810–3] 

Flumioxazin; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of flumioxazin in 

or on vegetable, cucurbit, group 9; leaf 

petioles subgroup 4B; and hop, dried 

cones. This regulation additionally 

deletes the existing tolerances on 

almond and melon, subgroup 9A, as 

they will be superseded by inclusion in 

tree nut group 14 and cucurbit vegetable 

group 9, respectively. Interregional 

Research Project Number 4 (IR-4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

February 24, 2010. Objections and 

requests for hearings must be received 

on or before April 26, 2010, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2008–0885. 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: 

Laura Nollen, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7390; e-mail address: 

nollen.laura@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to those engaged in the 

following activities: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather to provide a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s e-CFR 

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

To access the OPPTS harmonized test 

guidelines referenced in this document 

electronically, please go to http:// 

www.epa.gov/oppts and select ‘‘Test 

Methods and Guidelines.’’ 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 21 

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

objection to any aspect of this regulation 

and may also request a hearing on those 

objections. You must file your objection 

or request a hearing on this regulation 

in accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2008–0885 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 April 26, 2010. 

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–2008–0885, 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 Tolerance 

In the Federal Register of April 13, 

2009 (74 FR 16866) (FRL–8396–6), 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 8E7462) by IR-4, 

500 College Rd. East, Suite 201 W, 

Princeton, NJ 08540. The petition 

requested that 40 CFR 180.568 be 

amended by establishing tolerances for 

residues of the herbicide flumioxazin, 2- 

[7-fluoro-3,4-dihydro-3-oxo-4-(2- 

propynyl)-2 H -1,4-benzoxazin-6-yl]- 

4,5,6,7-tetrahydro-1 H -isoindole-1,3(2 H 

)-dione, in or on vegetable, cucurbit, 

group 9 at 0.03 parts per million (ppm); 

leaf petioles, subgroup 4B at 0.02 ppm; 

and hop, dried cones at 0.07 ppm. The 

petition additionally requested that EPA 

revoke the existing tolerance on 

almonds, as a tolerance on nut, tree, 

group 14 has been established; and 

requested that EPA delete the existing 

tolerance for melon subgroup 9A, 


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8262 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

because it will be replaced by the 

proposed tolerance for vegetable, 

cucurbit, group 9. That notice 

referenced a summary of the petition 

prepared on behalf of IR-4 by Valent 

U.S.A. Corporation, 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, EPA has revised 

the proposed tolerance on hop, dried 

cones. The reason for this change is 

explained in Unit IV.C. 

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.’’ 

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

of FFDCA, and the factors specified in 

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 for the petitioned-for 

tolerances for residues of flumioxazin 

on vegetable, cucurbit, group 9 at 0.03 

ppm; leaf petioles subgroup 4B at 0.02 

ppm; and hop, dried cones at 0.05 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing tolerances 

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. 

Flumioxazin has mild or no acute 

toxicity when administered via the oral, 

dermal and inhalation routes of 

exposure. It has little or no toxicity with 

respect to eye or skin irritation and is 

not a dermal sensitizer. Subchronic and 

chronic toxicity studies demonstrated 

that the key toxic effects associated with 

flumioxazin include anemia and 

impacts on the liver and the 

cardiovascular system. Hematologic 

(hematopoietic) effects of anemia were 

noted in rats, including alterations in 

hemoglobin parameters. Increased 

absolute and relative liver weights and/ 

or increased alkaline phosphatase 

values were observed in dogs. 

There was no evidence (quantitative 

or qualitative) of susceptibility 

following in-utero oral exposure in 

rabbits. Developmental studies in the rat 

resulted in cardiovascular anomalies, 

including ventricular septal defects. In 

the two-generation reproduction study, 

systemic effects (clinical signs and 

mortality as well as a decrease in body 

weight/gain and food consumption) 

were noted in males and females; more 

severe offspring effects (decrease in the 

number of live born and decreased pup 

body weights) were noted at lower doses 

than that which resulted in parental 

effects. 

None of the acute, subchronic, 

chronic, developmental or reproduction 

studies indicated an effect on the 

nervous systems. Based on the lack of 

evidence of carcinogenicity in mice and 

rats, flumioxazin is classified as ‘‘not 

likely to be carcinogenic to humans.’’ 

Flumioxazin did not induce significant 

increases in any tumor type in either 

rats or mice under the conditions of the 

studies, and it did not induce any 

mutagenic activity in the required 

battery of mutgenicity studies. 

Specific information on the studies 

received and the nature of the adverse 

effects caused by flumioxazin as well as 

the no-observed-adverse-effect-level 

(NOAEL) and the lowest-observedadverse-effect-level (LOAEL) from the 

toxicity studies can be found at http:// 

www.regulations.gov in the document 

‘‘Flumioxazin. Human Health Risk 

Assessment for the Proposed Aquatic 

Use and Proposed Food Uses on 

Cucurbit Vegetables, Leaf Petioles, and 

Hops,’’ at pages 58-62 in docket ID 

number EPA–HQ–OPP–2008-0885. 

B. Toxicological Endpoints 

For hazards that have a threshold 

below which there is no appreciable 

risk, a toxicological point of departure 

(POD) is identified as the basis for 

derivation of reference values for risk 

assessment. The POD may be defined as 

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) or a benchmark dose 

(BMD) approach is sometimes used for 

risk assessment. Uncertainty/safety 

factors (UFs) are used in conjunction 

with the POD 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 dietary risks by comparing 

aggregate food and water 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 POD by all applicable UFs. 

Aggregate short-, intermediate-, and 

chronic-term risks are evaluated by 

comparing food, water, and residential 

exposure to the POD to ensure that the 

margin of exposure (MOE) called for by 

the product of all applicable UFs is not 

exceeded. This latter value is referred to 

as the level of concern (LOC). 

For non-threshold risks, the Agency 

assumes that any amount of exposure 

will lead to some degree of risk. Thus, 

the Agency estimates risk in terms of the 

probability of an occurrence of the 

adverse effect greater than that expected 

in a lifetime. 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/ 

pesticides/factsheets/riskassess.htm. 

A summary of the toxicological 

endpoints for flumioxazin used for 

human risk assessment can be found at 

http://www.regulations.gov in the 

document ‘‘Flumioxazin. Human Health 

Risk Assessment for the Proposed 

Aquatic Use and Proposed Food Uses on 

Cucurbit Vegetables, Leaf Petioles, and 

Hops,’’ at pages 26-28 in docket ID 

number EPA–HQ–OPP–2008-0885. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to flumioxazin, EPA 

considered exposure under the 

petitioned-for tolerances as well as all 

existing flumioxazin tolerances in 40 

CFR 180.568. EPA assessed dietary 

exposures from flumioxazin in food as 

follows: 

i. Acute exposure. Quantitative acute 

dietary exposure and risk assessments 


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Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 8263 

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 effect was identified 

for the general population. However, 

EPA identified potential acute effects 

(cardiovascular effects in offspring) for 

the population subgroup, females 13 to 

49 years old. 

In estimating acute dietary exposure, 

EPA used food consumption 

information from the U.S. Department of 

Agriculture (USDA) 1994–1996 and 

1998 Nationwide Continuing Surveys of 

Food Intake by Individuals (CSFII). As 

to residue levels in food, EPA used 

tolerance-level residues, Dietary 

Exposure Evaluation Model (DEEM) 

default processing factors for all 

processed commodities (with the 

exception of tomato, which used the 

empirical processing factor of 1x), and 

assumed 100 percent crop treated (PCT) 

for all proposed commodities. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure 

assessment, EPA used the food 

consumption data from the USDA 1994– 

1996 and 1998 CSFII. As to residue 

levels in food, EPA used tolerance-level 

residues, DEEM default processing 

factors for all processed commodities 

(with the exception of tomato, which 

used the empirical processing factor of 

1x), and assumed 100 PCT for all 

proposed commodities. 

iii. Cancer. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

EPA has classified flumioxazin as ‘‘not 

likely to be carcinogenic to humans.’’ 

Therefore, a quantitative exposure 

assessment to evaluate cancer risk is 

unnecessary. 

iv. Anticipated residue and percent 

crop treated (PCT) information. EPA did 

not use anticipated residue or PCT 

information in the dietary assessment 

for flumioxazin. Tolerance level 

residues or 100 PCT were assumed for 

all food commodities. 

2. Dietary exposure from drinking 

water. A hydrolysis study for 

flumioxazin indicates that flumioxazin 

forms the metabolite 482-HA, which can 

further hydrolyze into the metabolites 

APF and THPA. The rates of the two 

hydrolytic reactions are very pH 

dependent, but flumioxaxin is not very 

stable at any likely environmental pH. 

Data also indicates that THPA and APF 

are likely to be very mobile. Although 

THPA can comprise a major portion of 

the total residue in water, it does not 

possess a phenyl ring and is thus 

considered significantly less toxic than 

flumioxazin, APF, and 482-HA. For this 

reason, THPA has not been included as 

a residue of concern in drinking water. 

Therefore, the residues of concern in 

drinking water are flumioxazin and its 

482-HA and APF degradates. The 

Agency used screening level water 

exposure models in the dietary exposure 

analysis and risk assessment for 

flumioxazin and its degradates of 

concern in drinking water. These 

simulation models take into account 

data on the physical, chemical, and fate/ 

transport characteristics of flumioxazin 

and its degradates of concern. 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) model, the 

estimated drinking water concentrations 

(EDWCs) of flumioxazin, 482-HA and 

APF for acute exposures are estimated 

to be 1.03 parts per billion (ppb), 6.87 

ppb, and 26.46 ppb, respectively, for 

surface water. For chronic exposures for 

non-cancer assessments, the EDWCs of 

482-HA and APF are estimated to be 

4.84 ppb and 12.85 ppb, respectively, 

for surface water. Based on the 

Screening Concentration in Ground 

Water (SCI-GROW) model, for both 

acute and chronic (non-cancer) 

exposures, the EDWCs of 482-HA and 

APF are estimated to be 45.27 ppb and 

2.66 ppb, respectively, for ground water. 

EDWCs of flumioxazin are estimated to 

be negligible in ground water for acute 

exposures and in both surface and 

ground water for chronic exposures. 

Modeled estimates of drinking water 

concentrations were directly entered 

into the dietary exposure model. The 

EDWC of 48 ppb (0.048 ppm), the total 

EDWC for flumioxazin residues in 

groundwater (including flumioxazin, 

482-HA, and APF), was used to assess 

the contribution to drinking water for 

both the acute and chronic dietary risk 

assessments. 

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). 

Flumioxazin is currently registered 

for use in the following areas that could 

result in residential exposures: 

Walkways, parking lots and non-grassy 

areas around residential dwellings. EPA 

assessed residential exposure using the 

following assumptions: Short-term 

dermal and inhalation exposure to adult 

handlers resulting from the use of 

flumioxazin within residential settings. 

For the above use sites, no 

postapplication exposure to adults or 

children from flumioxazin is expected. 

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.’’ 

EPA has not found flumioxazin to 

share a common mechanism of toxicity 

with any other substances, and 

flumioxazin does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that flumioxazin does not have 

a common mechanism of toxicity with 

other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

D. Safety Factor for Infants and 

Children 

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

FFDCA provides that EPA shall apply 

an additional tenfold (10X) margin of 

safety for infants and children in the 

case of threshold effects to account for 

prenatal and postnatal toxicity and the 

completeness of the database on toxicity 

and exposure unless EPA determines 

based on reliable data that a different 

margin of safety will be safe for infants 

and children. This additional margin of 

safety is commonly referred to as the 

FQPA 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. 

2. Prenatal and postnatal sensitivity. 

The prenatal and postnatal toxicology 

database for flumioxazin includes rat 

and rabbit prenatal developmental 

toxicity studies and a two-generation 

reproduction toxicity study in rats. 

There is no evidence of increased 

susceptibility following in-utero oral 

exposure in rabbits; however, there is 

evidence of increased quantitative 

susceptibility of rat fetuses to in utero 

exposure to flumioxazin in the oral and 

dermal developmental studies. In both 

studies, there was an increased 

incidence in fetal cardiovascular 

anomalies (including ventricular septal 

defects) in the absence of maternal 

toxicity. Additionally, quantitative 

susceptibility was observed in the twoVerDate Nov<24>2008 15:09 Feb 23, 2010 Jkt 220001 PO 00000 Frm 00025 Fmt 4700 Sfmt 4700 E:\FR\FM\24FER1.SGM 24FER1

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8264 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

generation rat reproduction study, in 

which offspring effects (decrease in the 

number of live born and decreased pup 

body weights) were observed at lower 

doses than those which caused parental/ 

systemic toxicity (red substance in 

vagina and increased mortality in 

females as well as decreases in male and 

female body weights, body weight gains 

and food consumption). 

3. Conclusion. EPA has determined 

that reliable data show the safety of 

infants and children would be 

adequately protected if the FQPA SF 

were reduced to 1X. That decision is 

based on the following findings: 

i. The toxicity database for 

flumioxazin is complete except for 

immunotoxicity, acute neurotoxicity, 

and subchronic neurotoxicity testing. 

Recent changes to 40 CFR part 158 make 

acute and subchronic neurotoxicity 

testing (OPPTS Guideline 870.6200), 

and immunotoxicity testing (OPPTS 

Guideline 870.7800) required for 

pesticide registration; however, the 

existing data are sufficient for endpoint 

selection for exposure/risk assessment 

scenarios, and for evaluation of the 

requirements under the FQPA. 

The available data for flumioxazin do 

not show the potential for neurotoxic 

effects. In the subchronic and chronic 

toxicity studies, signs of anemia (a 

potential immunotoxic effect) were 

observed. In the rat, hematologic 

(hematopoietic) effects of anemia were 

noted, including alterations in 

hemoglobin parameters. Flumioxazin is 

a protporphyrinogen oxidase (PPO) 

inhibitor, which inhibits the 

biosynthesis of chlorophyll in plants 

(giving flumioxazin its weed-control 

properties). In animals, PPO is 

responsible for one of the later steps in 

heme synthesis; therefore, the inhibition 

of PPO results in anemia. Although 

anemia can potentially be considered an 

immunotoxic effect, in this case it’s 

likely the anemia is due to the inhibited 

heme formation (which can interfere 

with the porphyrin component of heme, 

a hematopoietic effect resulting in 

anemia), and the blood effects are not 

considered to be the result of potential 

immunotoxicity in this case. Thus, EPA 

has concluded that flumioxazin does 

not directly impact the nervous system 

or directly target the immune system. 

The Agency does not believe that 

conducting a functional immunotoxicity 

study will result in a NOAEL lower than 

the regulatory dose for risk assessment; 

therefore, an additional database 

uncertainty factor is not needed to 

account for potential immunotoxicity or 

neurotoxicity. 

ii. There is no indication that 

flumioxazin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is evidence of increased 

quantitative susceptibility of the young 

following exposure to flumioxazin in 

the oral and dermal developmental 

toxicity studies in the rat and in the 

two-generation rat reproduction study; 

therefore, a degree of concern analysis 

was performed to determine the level of 

concern for the effects observed when 

considered in the context of all available 

toxicity data and to identify any 

residual concerns after establishing 

toxicity endpoints and traditional UFs 

to be used in the flumioxazin risk 

assessment. In considering the overall 

toxicity profile and the endpoints and 

doses selected for the flumioxazin risk 

assessment, EPA characterized the 

degree of concern for the susceptibility 

observed in the rat developmental and 

two-generation reproductive studies as 

low and determined that there are no 

residual uncertainties for prenatal and/ 

or postnatal toxicity because: 

a. The only missing toxicity data for 

flumioxazin are the newly required 

neurotoxicity and immunotoxicity 

studies; however, no additional UF is 

needed in the absence of these studies 

because there is no evidence to indicate 

that flumioxazin targets the nervous 

system or the immune system. Further, 

EPA has concluded that a 

developmental neurotoxicity study is 

not required. 

b. There are clear NOAELs and 

LOAELs for the developmental and 

offspring effects noted in the rat 

developmental toxicity and twogeneration reproductive toxicity studies, 

and the doses and endpoints have been 

selected from these studies for risk 

assessment for the relevant exposed 

populations, i.e., pregnant females and 

children (with the exception of the 

chronic dietary endpoint, for which a 

chronic study was chosen for endpoint 

selection). 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on conservative 

assumptions, including 100 PCT data 

and tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to flumioxazin 

in drinking water. Postapplication 

exposure to children is not expected. 

These assessments will not 

underestimate the exposure and risks 

posed by flumioxazin. 

E. Aggregate Risks and Determination of 

Safety 

EPA determines whether acute and 

chronic pesticide exposures are safe by 

comparing aggregate exposure estimates 

to the aPAD and cPAD. The aPAD and 

cPAD represent the highest safe 

exposures, taking into account all 

appropriate SFs. EPA calculates the 

aPAD and cPAD by dividing the POD by 

all applicable UFs. For linear cancer 

risks, EPA calculates the probability of 

additional cancer cases given the 

estimated aggregate exposure. Short-, 

intermediate-, and chronic-term risks 

are evaluated by comparing the 

estimated aggregate food, water, and 

residential exposure to the POD to 

ensure that the MOE called for by the 

product of all applicable UFs is not 

exceeded. 

1. Acute risk. Using the exposure 

assumptions discussed in this unit for 

acute exposure, the acute dietary 

exposure from food and water to 

flumioxazin will occupy 9% of the 

aPAD for females 13 to 49 years old, the 

population subgroup where a potential 

acute risk was identified. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to flumioxazin 

from food and water will utilize 19% of 

the cPAD for children less than 1 year 

old, the population group receiving the 

greatest exposure. Based on the 

explanation in Unit III.C.3., regarding 

residential use patterns, chronic 

residential exposure to residues of 

flumioxazin is not expected. 

3. Short-term risk. Short-term 

aggregate exposure takes into account 

short-term residential exposure plus 

chronic exposure to food and water 

(considered to be a background 

exposure level). 

Flumioxazin is currently registered 

for uses that could result in short-term 

residential exposure and the Agency has 

determined that it is appropriate to 

aggregate chronic exposure through food 

and water with short-term residential 

exposures to flumioxazin. Using the 

exposure assumptions described in this 

unit for short-term exposures, EPA has 

concluded that the combined short-term 

food, water, and residential exposures 

aggregated result in aggregate MOEs of 

2,400 or greater. As the aggregate MOEs 

for short-term exposure are greater than 

100 (the LOC) for all exposure scenarios, 

short-term aggregate exposures to 

flumioxazin are not of concern to EPA. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

residential exposure plus chronic 


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Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 8265 

exposure to food and water (considered 

to be a background exposure level). 

Flumioxazin is not registered for any 

use patterns that would result in 

intermediate-term residential exposure. 

Therefore, the intermediate-term 

aggregate risk is the sum of the risk from 

exposure to flumioxazin through food 

and water, which has already been 

addressed, and will not be greater than 

the chronic aggregate risk. 

5. Aggregate cancer risk for U.S. 

population. Based on the lack of 

evidence of carcinogenicity in two 

adequate rodent carcinogenicity studies, 

flumioxazin 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 flumioxazin 

residues. 

IV. Other Considerations 

A. Analytical Enforcement Methodology 

The following adequate enforcement 

methodology is available to enforce the 

tolerance expression: A gas 

chromatography/nitrogen-phosphorus 

detection (GC/NPD) method. 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; email address: residuemethods@epa.gov. 

B. International Residue Limits 

There are no Codex, Canadian or 

Mexican maximum residue limits 

established for residues of flumioxazin 

on commodities associated with this 

petition. 

C. Revisions to Petitioned-For 

Tolerances 

Based on analysis of the residue field 

trial data supporting the petition, EPA 

revised the proposed tolerance on hop, 

dried cones from 0.07 ppm to 0.05 ppm. 

EPA revised this tolerance level based 

on analysis of the residue field trial data 

using the Agency’s Tolerance 

Spreadsheet in accordance with the 

Agency’s Guidance for Setting Pesticide 

Tolerances Based on Field Trial Data. 

EPA has also revised the introductory 

text in § 180.568 to clarify in the 

tolerance expression: (1) That, as 

provided in FFDCA section 408(a)(3), 

the tolerance covers metabolites and 

degradates of flumioxazin not 

specifically mentioned; and (2) that 

compliance with the specified tolerance 

levels is to be determined by measuring 

only the specific compounds mentioned 

in the tolerance expression. 

V. Conclusion 

Therefore, tolerances are established 

for residues of flumioxazin, 2-[7-fluoro3,4-dihydro-3-oxo-4-(2-propynyl)-2H 

-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro1H-isoindole-1,3(2H)-dione, in or on 

vegetable, cucurbit, group 9 at 0.03 

ppm; leaf petioles subgroup 4B at 0.02 

ppm; and hop, dried cones at 0.05 ppm. 

VI. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA), 44 U.S.C. 3501 et 

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerances 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) (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: February 1, 2010. 

Daniel J. Rosenblatt, 

Acting Director, Registration Division, Office 

of Pesticide Programs. 

■ Therefore, 40 CFR chapter I is 

amended as follows: 

PART 180—[AMENDED] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. Section 180.568 is amended in 

paragraph (a) by revising the 

introductory text, removing the entries 

for ‘‘Almond’’ and ‘‘Melon, subgroup 9A’’ 

from the table; and by alphabetically 

adding ‘‘Hop, dried cones’’; ‘‘Leaf 

petioles subgroup 4B’’; and ‘‘Vegetable, 

cucurbit, group 9’’ to the table to read as 

follows: 


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8266 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

§ 180.568 Flumioxazin; tolerances for 

residues. 

(a) * * * Tolerances are established 

for residues of flumioxazin, 2-[7-fluoro3,4-dihydro-3-oxo-4-(2-propynyl)-2H1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro1H-isoindole-1,3(2H)-dione, including 

its metabolites and degradates, in or on 

the commodities in the table below. 

Compliance with the tolerance levels 

specified below is to be determined by 

measuring only flumioxazin. 

Commodity Parts per million 

* * * * * 

Hop, dried cones .................. 0.05 

Leaf petioles subgroup 4B ... 0.02 

* * * * * 

Vegetable, cucurbit, group 9 0.03 

* * * * * 

* * * * * 

[FR Doc. 2010–3166 Filed 2–23–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Subchapter R 

[EPA–HQ–OPPT–2007–0392; FRL–8798–9] 

RIN 2070–AJ21 

Final Clarification for Chemical 

Identification Describing Activated 

Phosphors for TSCA Inventory 

Purposes 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final clarification. 

SUMMARY: This is a clarification under 

which certain activated phosphors that 

are not on the Toxic Substances Control 

Act (TSCA) section 8(b) Chemical 

Substance Inventory (TSCA Inventory) 

will be considered to be new chemical 

substances under TSCA section 5, and 

thus will be subject to applicable 

notification requirements under TSCA 

section 5. In certain letters and other 

statements issued by EPA from 1978 to 

2003, the Agency erroneously indicated 

that activated phosphors (otherwise 

known as doped phosphors) constitute 

mixtures of phosphors and dopants for 

purposes of the TSCA Inventory, and 

thus that they were not separately 

reportable as chemical substances under 

TSCA section 5(a) new chemical 

notification requirements. This 

clarification is necessary because EPA’s 

statements in this area have not been 

consistent. 

DATES: EPA’s clarification is effective 

August 24, 2011. 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPPT–2007–0392. 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 OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

general information contact: Colby 

Lintner, Regulatory Coordinator, 

Environmental Assistance Division 

(7408M), Office of Pollution Prevention 

and Toxics, Environmental Protection 

Agency, 1200 Pennsylvania Ave., NW., 

Washington, DC 20460–0001; telephone 

number: (202) 554–1404; e-mail address: 

TSCA-Hotline@epa.gov. 

For technical information contact: 

David Schutz, Chemical Control 

Division (7405M), Office of Pollution 

Prevention and Toxics, Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001; telephone number: (202) 564– 

9262; e-mail address: schutz.david 

@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Does this Action Apply to Me? 

You may be affected by this action if 

you are, or may in the future be, a 

manufacturer or importer of an activated 

phosphor that requires submission of a 

premanufacture notification (PMN) or 

exemption request under TSCA section 

5. Special procedures will apply to 

persons who manufactured these 

chemical substances after the 

publication of the Initial TSCA 

Inventory and before the effective date 

of this final chemical identification 

clarification document in the Federal 

Register. Potentially affected entities 

may include, but are not limited to: 

• Chemical manufacturers or 

importers (NAICS codes 325, 3251), e.g., 

anyone who manufactures or imports, or 

who plans to manufacture or import, an 

activated phosphor for a non-exempt 

commercial purpose. 

• Electric lighting equipment 

manufacturing, electric lamp bulb and 

part manufacturing (NAICS codes 3351, 

33511), e.g., anyone who manufactures 

or imports, or who plans to manufacture 

or import, lighting equipment 

containing an activated phosphor for a 

non-exempt commercial purpose. 

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 technical person listed under FOR

FURTHER INFORMATION CONTACT. 

II. Background 

A. What Action is the Agency Taking? 

EPA is clarifying that certain previous 

EPA statements which indicated that 

activated phosphors are mixtures rather 

than chemical substances in their own 

right were erroneous, and that TSCA 

Inventory listing may be required for 

these materials. This action provides a 

clarification in the approach used for 

the chemical identification of activated 

(doped) phosphors for purposes of 

listing on the TSCA Inventory. This 

clarification was proposed in the 

Federal Register issue of January 16, 

2008 (73 FR 2854) (FRL–8131–8) and a 

reopening of comments on the proposed 

clarification was announced in the 

Federal Register issue of May 2, 2008 

(73 FR 24187) (FRL–8360–7). 

An activated phosphor is a substance 

resulting from the chemical 

combination of a mixture of metal 

oxides, carbonates, phosphates or acid 

phosphates, chlorides, and/or fluorides, 

most frequently by sintering, along with 

a small amount of one or more dopants. 

Dopants can include such substances as 


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