8256 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

VII. Other Considerations 

A. Endocrine Disruptors 

There is no evidence, at this time, that 

suggests that laminarin will compromise 

the endocrine system, function in a 

manner similar to any known hormone, 

or act as an endocrine disruptor. 

B. Analytical Method(s) 

Through this action, the Agency 

proposes an exemption from the 

requirement of a tolerance of laminarin 

when used on food commodities, 

without any numerical limitations for 

residues. EPA has determined that 

residues resulting from the pesticidal 

use of laminarin are unlikely and that 

there are no significant toxicity 

concerns in the event that residues of 

the active ingredient are present. As a 

result, the Agency has concluded that 

an analytical method is not required for 

enforcement purposes for laminarin. 

C. Codex Maximum Residue Level 

There are no codex maximum residue 

levels established for residues of 

laminarin. 

VIII. Conclusions 

Based on the data submitted to 

support this tolerance exemption, and 

other information available to the 

Agency, EPA is establishing an 

exemption from the tolerance 

requirements, pursuant to FFDCA 

section 408(c), for residues of laminarin 

in or on all food commodities. 

IX. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

Flexibility Act (RFA) (5 U.S.C. 601 et 

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

of section 408(n)(4) of FFDCA. As such, 

the Agency has determined that this 

action will not have a substantial direct 

effect on States or tribal governments, 

on the relationship between the national 

government and the States or tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

tribes. Thus, the Agency has determined 

that Executive Order 13132, entitled 

Federalism (64 FR 43255, August 10, 

1999) and Executive Order 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this final rule. In addition, this final 

rule does not impose any enforceable 

duty or contain any unfunded mandate 

as described under Title II of the 

Unfunded Mandates Reform Act of 1995 

(UMRA) (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). 

X. 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 15, 2010. 

Steven Bradbury, 

Acting Director, Office of Pesticide Programs. 

■ Therefore, 40 CFR part 180 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 180.1295 is added to 

subpart D to read as follows: 

§ 180.1295 Laminarin; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of laminarin in or on all food 

commodities when laminarin is applied 

preharvest. 

[FR Doc. 2010–3672 Filed 2–23–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

EPA–HQ–OPP–2009–0569; FRL–8812–5 

Nicosulfuron; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

time-limited tolerances for residues of 

nicosulfuron, [3-pyridinecarboxamide, 

2-((((4,6-dimethoxypyrimidin-2-yl) 

aminocarbonyl) aminosulfonyl))-N,Ndimethyl]; in or on Bermudagrass, 

forage and Bermudagrass, hay. This 

action is in response to EPA granting 

crisis exemptions to the Texas 

Department of Agriculture and the 

Oklahoma Department of Agriculture 

under section 18 of the Federal 

Insecticide, Fungicide, and Rodenticide 

Act (FIFRA) authorizing use of the 

pesticide on Bermudagrass, forage and 

Bermudagrass, hay. This regulation 

establishes maximum permissible levels 

for residues of nicosulfuron in 

Bermudagrass and hay. The timelimited tolerances expire and are 

revoked on December 31, 2011. 

DATES: This regulation is effective 

February 24, 2010. Objections and 


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Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 8257 

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–2009–0569. All documents in the 

docket are listed in the docket index 

available in 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: 

Stacey Groce, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–2505; e-mail address: 

groce.stacey@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. General Information 

A. Does this Action Apply to Me? 

You may be potentially affected by 

this action if you are an agricultural 

producer, food manufacturer, or 

pesticide manufacturer. Potentially 

affected entities may include, but are 

not limited to: 

•Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

This listing is not intended to be 

exhaustive, but rather provides a guide 

for readers regarding entities likely to be 

affected by this action. Other types of 

entities not listed in this unit could also 

be affected. The North American 

Industrial Classification System 

(NAICS) codes have been provided to 

assist you and others in determining 

whether this action might apply to 

certain entities. If you have any 

questions regarding the applicability of 

this action to a particular entity, consult 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

B. How Can I Get Electronic Access to 

Other Related Information? 

You may access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of the Federal 

Food, Drug, and Cosmetic Act (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. 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–2009–0569 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 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 your 

copies, identified by docket ID number 

EPA–HQ–OPP–2009-0569, 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. Background and Statutory Findings 

EPA, on its own initiative, in 

accordance with sections 408(e) and 

408(l)(6) of FFDCA, 21 U.S.C. 346a(e) 

and 346a(1)(6), is establishing timelimited tolerances for residues of the 

herbicide nicosulfuron, in or on 

Bermudagrass, forage and 

Bermudagrass, hay at 10 parts per 

million (ppm) and 25 (ppm) 

respectively. These time-limited 

tolerances expire and are revoked on 

December 31, 2011. EPA will publish a 

document in the Federal Register to 

remove the revoked tolerances from the 

Code of Federal Regulations (CFR). 

Section 408(l)(6) of FFDCA requires 

EPA to establish a time-limited 

tolerance or exemption from the 

requirement for a tolerance for pesticide 

chemical residues in food that will 

result from the use of a pesticide under 

an emergency exemption granted by 

EPA under section 18 of FIFRA. Such 

tolerances can be established without 

providing notice or period for public 

comment. EPA does not intend for its 

actions on FIFRA section 18 related 

time-limited tolerances to set binding 

precedents for the application of section 

408 of FFDCA to other tolerances and 

exemptions. Section 408(e) of FFDCA 

allows EPA to establish a tolerance or an 

exemption from the requirement of a 

tolerance on its own initiative, i.e., 

without having received any petition 

from an outside party. 

Section 18 of FIFRA authorizes EPA 

to exempt any Federal or State agency 

from any provision of FIFRA, if EPA 

determines that ‘‘emergency conditions 

exist which require such exemption.’’ 

EPA has established regulations 

governing such emergency exemptions 

in 40 CFR part 166. 

III. Emergency Exemption for 

Nicosulfuron on Bermudagrass Forage 

and Hay and FFDCA Tolerances 

The Texas and Oklahoma 

Departments of Agriculture requested 

emergency exemptions for use of 

nicosulfuron on Bermudagrass and hay 

to control field sandbur species, and 

issued crisis exemptions for this use 

pursuant to 40 CFR part 166, subpart C 

of FIFRA. The states provided 

information indicating that sandbur 

species is a serious pest that commonly 

infests Bermudagrass and hay. 

As part of its evaluation of the 

emergency exemption applications, EPA 

assessed the potential risks presented by 

residues of nicosulfuron in or on 

Bermudagrass, forage and 

Bermudagrass, hay. In doing so, EPA 


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8258 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

considered the safety standard in 

section 408(b)(2) of FFDCA, and EPA 

decided that the necessary tolerances 

under section 408(l)(6) of FFDCA would 

be consistent with the safety standard 

and with FIFRA section 18. Consistent 

with the need to move quickly on the 

emergency exemptions in order to 

address urgent non-routine situations 

and to ensure that the resulting food is 

safe and lawful, EPA is issuing these 

tolerances without notice and 

opportunity for public comment as 

provided in section 408(l)(6) of FFDCA. 

Although these time-limited tolerances 

expire and are revoked on December 31, 

2011, under section 408(l)(5) of FFDCA, 

residues of the pesticide not in excess 

of the amounts specified in the 

tolerances remaining in or on 

Bermudagrass, forage and 

Bermudagrass, hay after that date will 

not be unlawful, provided the pesticide 

was applied in a manner that was lawful 

under FIFRA, and the residues do not 

exceed a level that was authorized by 

these time-limited tolerances at the time 

of that application. EPA will take action 

to revoke these time-limited tolerances 

earlier if any experience with, scientific 

data on, or other relevant information 

on this pesticide indicate that the 

residues are not safe. 

Because these time-limited tolerances 

are being approved under emergency 

conditions, EPA has not made any 

decisions about whether nicosulfuron 

meets FIFRA’s registration requirements 

for use on Bermudagrass, forage and 

Bermudagrass, hay or whether 

permanent tolerances for this use would 

be appropriate. Under these 

circumstances, EPA does not believe 

that these time-limited tolerance 

decisions serve as a basis for registration 

of nicosulfuron by a State for special 

local needs under FIFRA section 24(c). 

Nor do these tolerances serve as the 

basis for persons in any States other 

than Texas and Oklahoma to use this 

pesticide on the applicable crops under 

FIFRA section 18 absent the issuance of 

an emergency exemption applicable 

within that State. For additional 

information regarding the emergency 

exemptions for nicosulfuron, contact the 

Agency’s Registration Division at the 

address provided under FOR FURTHER

INFORMATION CONTACT. 

IV. 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 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 expected as a result 

of these emergency exemption requests 

and the time-limited tolerances for 

residues of nicosulfuron [3- 

pyridinecarboxamide, 2-((((4,6- 

dimethoxypyrimidin-2-yl) 

aminocarbonyl) aminosulfonyl))-N,Ndimethyl] in or on Bermudagrass, forage 

and Bermudagrass, hay at 10 ppm and 

25 ppm respectively. EPA’s assessment 

of exposures and risks associated with 

establishing time-limited tolerances 

follows. 

A. 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 nicosulfuron used for 

human risk assessment can be found at 

http://www.regulations.gov in the July 

14, 2009 document ‘‘Nicosulfuron: 

Human Health Risk Assessment for 

Proposed Section 18 Use on 

Bermudagrass,’’ pages 10 and 11 of 30 in 

docket ID number EPA–HQ–OPP–2009– 

0569. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to nicosulfuron, EPA 

considered exposure under the timelimited tolerances established by this 

action as well as exposures pursuant to 

existing tolerances in (40 CFR 180.454). 

EPA assessed dietary exposures from 

nicosulfuron in food as follows: 

i. Acute exposure. No acute effects 

were identified in the toxicological 

studies for nicosulfuron; therefore, a 

quantitative assessment of acute dietary 

exposure was not conducted. 

ii. Chronic exposure. In conducting 

the chronic dietary exposure assessment 

EPA used tolerance level residues and 

100 percent crop treated (PCT) 

assumptions for all registered and 

proposed commodities. 

iii. Cancer. EPA has classified 

nicosulfuron as ‘‘not likely to be 

carcinogenic to humans’’ based on the 

lack of tumorigenic effects in rodent (rat 

and mice) bioassays at the limit doses 

and lack of mutagenic effects in the in 

vitro and in vivo genotoxicity assays. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for nicosulfuron. Tolerance level 

residues and/or 100 PCT were assumed 

for all registered and proposed food 

commodities. 


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Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 8259 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for nicosulfuron in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

nicosulfuron. 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 surface 

water and the Screening Concentration 

in Ground Water (SCI-GROW) model for 

ground water, the estimated drinking 

water concentrations (EDWCs) of 

nicosulfuron for chronic exposures for 

non-cancer assessments are estimated to 

be 0.7 parts per billion (ppb) for surface 

water and 0.06 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 0.7 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). 

Nicosulfuron is not registered for any 

specific use patterns that would result 

in residential exposure. Therefore, a 

residential risk assessment was not 

conducted. 

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 nicosulfuron to 

share a common mechanism of toxicity 

with any other substances, and 

nicosulfuron does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that nicosulfuron 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 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 website at http:// 

www.epa.gov/pesticides/cumulative. 

C. 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 

Food Quality Protection Act (FQPA) SF. 

In applying this provision, EPA either 

retains the default value of 10X, or uses 

a different additional SF when reliable 

data available to EPA support the choice 

of a different factor. 

2. Prenatal and postnatal sensitivity. 

There is no quantitative or qualitative 

evidence of increased susceptibility 

observed following in utero 

nicosulfuron exposure to rats or rabbits 

in the prenatal developmental studies or 

following prenatal/postnatal exposure 

in young rats in the 2–generation 

reproduction study. The toxicity 

database is considered adequate and 

includes acceptable developmental 

toxicity studies in the rat and rabbit and 

a rat reproductive study. 

There were no developmental or 

reproductive effects observed in rats, 

but in rabbits (clinical signs, decreased 

body weight gain during dosing, 

increased abortions), postimplantation 

loss and decreased fetal body weight 

were observed at the maternal toxicity 

LOAEL. However, these effects were 

only observed at maternally toxic doses. 

3. Conclusion. EPA has determined 

that reliable data show that 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 

nicosulfuron is considered adequate for 

purposes of assessing human health risk 

from this emergency exemption use. 

Available data suggest that nicosulfuron 

is poorly absorbed and that toxicity is 

low. Further, data suggest increased pre 

and/or post natal susceptibility was not 

observed. 

ii. The toxicity database for 

nicosulfuron is generally complete 

except for more recently required 

neurotoxicity and immunotoxicity 

testing requirements. 

iii. There is no evidence of 

neurotoxicity or immunotoxicity in the 

available studies. 

iv. There are no residual uncertainties 

with regard to assessing pre-and/or 

postnatal toxicity. 

v. There are no residential use 

patterns for this chemical and the 

exposure assessments are conservative 

and will not underestimate risks. 

D. 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. An acute aggregate risk 

assessment takes into account exposure 

estimates from acute dietary 

consumption of food and drinking 

water. None of the toxicology studies 

available for nicosulfuron indentified an 

adverse effect resulting from a singleoral exposure; therefore, dietary 

exposure presents no acute risks of 

concern. 

2. Chronic risk. Using the exposure 

assumptions described in this unit for 

chronic exposure, EPA has concluded 

that chronic exposure to nicosulfuron 

from food and water will utilize <1% of 

the cPAD for (children 3-5) the 

population subgroup receiving the 

greatest exposure. There are no 

residential uses for nicosulfuron. As 

explained in the unit regarding 

residential use patterns, chronic 

residential exposure to residues of 

nicosulfuron is not expected, so chronic 

risk is a function of dietary exposure 

alone. Thus, the chronic aggregate 

exposure for the most exposed group is 

below EPA’s level of concern. 

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). 

Nicosulfuron is not registered for any 

use patterns that would result in 

residential exposure. Therefore, the 

short-term aggregate risk is the sum of 


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8260 Federal Register / Vol. 75, No. 36 / Wednesday, February 24, 2010 / Rules and Regulations 

the risk from exposure to nicosulfuron 

through food and water and will not be 

greater than the chronic aggregate risk. 

4. Intermediate-term risk. 

Intermediate-term aggregate exposure 

takes into account intermediate-term 

non-dietary, non-occupational exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Nicosulfuron 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 nicosulfuron 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.There is no cancer risk 

associated with the proposed use. 

Nicosulfuron is ‘‘not likely to be 

carcinogenic to humans’’ based on lack 

of tumorigenic effects in rodent (rats 

and mice) bioassays at the limit doses 

and lack of mutagenic effects in the in 

vitro and in vivo genotoxicity studies. 

6. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is reasonable certainty that no 

harm will result to the general 

population, or to infants and children, 

from chronic aggregate exposure to 

nicosulfuron residues from food and 

drinking water. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

An adequate enforcement 

methodology (Ciba-Geigy, AG-499, and 

High Performance Liquid 

Chromatography/Ultraviolet (PLC/UV) 

method)) is available to enforce the 

time-limited tolerance expression. The 

method was recommended for inclusion 

in the Pesticide Analytical Manual Vol. 

II (PAM II). 

B. International Residue Limits 

There are currently no Canadian, 

Mexican, or Codex maximum residue 

limits (MRLs) for nicosulfuron on the 

commodities for which tolerances are 

being established. 

VI. Conclusion 

Therefore, time-limited tolerances are 

established for residues of the herbicide 

nicosulfuron, [3-pyridineccarboxamide, 

2-((((4,6-dimethoxypyrimidin-2-yl) 

aminocarbonyl)aminosulfonyl))-N,Ndimethyl], in or on Bermudagrass, 

forage and Bermudagrass, hay at 10 ppm 

and 25 ppm respectively. These 

tolerances expire and are revoked on 

December 31, 2011. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under sections 408(e) and 408(l)(6) 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 in accordance with 

sections 408(e) and 408(l)(6) 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). 

VIII. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report to each House of 

the Congress and to the Comptroller 

General of the United States. EPA will 

submit a report containing this rule and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication of this final rule in the 

Federal Register. This final rule is not 

a ‘‘major rule’’ as defined by 5 U.S.C. 

804(2). 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 5, 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 180.454 redesignate the 

existing paragraph as paragraph (a) and 

add paragraph (b) to read as follows: 

§ 180.454 Nicosulfuron; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of the herbicide nicosulfuron, 

[3-pyridineccarboxamide, 2-((((4,6- 

dimethoxypyrimidin-2-yl) 

aminocarbonyl)aminosulfonyl))-N,Ndimethyl], in or on the specified 

agricultural commodities, resulting from 

use of the pesticide pursuant to FFIFRA 

section 18 emergency exemptions. The 

tolerances expire and are revoked on the 

date specified in the table. 


cprice-sewell on DSK2BSOYB1PROD with RULES
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, 


cprice-sewell on DSK2BSOYB1PROD with RULES