19268 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

Inert ingredients Limits Uses 

* * * * * * * 

Alkyl (C12-C16) dimethyl ammonio acetate (CAS Reg. Nos. 683–10– 

3, 2601–33–4 and 693–33–4 

20% by weight in pesticide formulation Surfactant 

* * * * * * * 

■ 3. In §180.930, in the table add 

alphabetically the following inert 

ingredient to read as follows: 

§ 180.930 Inert ingredients applied to 

animals; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

* * * * * * * 

Alkyl (C12-C16) dimethyl ammonio acetate (CAS Reg. Nos. 683–10– 

3, 2601–33–4 and 693–33–4 

20% by weight in pesticide formulation Surfactant 

* * * * * * * 

[FR Doc. 2010–8298 Filed 4–13–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2008–0695; FRL–8808–7] 

Kasugamycin; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

kasugamycin, 3-O-[2-amino-4- 

[(carboxyiminomethyl)amino]-2,3,4,6- 

tetradeoxy-a-D-arabino-hexopyranosyl]- 

D-chiro-inositol in or on apples. This 

action is in response to EPA’s granting 

of an emergency exemption under 

section 18 of the Federal Insecticide, 

Fungicide, and Rodenticide Act (FIFRA) 

authorizing use of the agricultural 

bactericide on apples. This regulation 

establishes a maximum permissible 

level for residues of kasugamycin in this 

food commodity. The time-limited 

tolerance expires and is revoked on 

December 31, 2012. 

DATES: This regulation is effective April 

14, 2010. Objections and requests for 

hearings must be received on or before 

June 14, 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–2008–0695. 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: 

Andrew Ertman, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9367; e-mail address: 

ertman.andrew@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 site 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 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–2008–0695 in the subject line on 

the first page of your submission. All 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 19269 

requests must be in writing, and must be 

mailed or delivered to the Hearing Clerk 

on or before June 14, 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–2008–0695, 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 a timelimited tolerance for residues of the 

agricultural bactericide kasugamycin,3- 

O-[2-amino-4- 

[(carboxyiminomethyl)amino]-2,3,4,6- 

tetradeoxy-a-D-arabino-hexopyranosyl]- 

D-chiro-inositol in or on apples at 0.05 

parts per million (ppm). This timelimited tolerance expires and is revoked 

on December 31, 2012. EPA will publish 

a document in the Federal Register to 

remove the revoked tolerances from the 

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 and the new safety 

standard 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 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. . . .’’ 

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 

Kasugamycin on Apples and FFDCA 

Tolerances 

The State of Michigan requested the 

use of kasugamycin on apples to control 

severe infestations of the bacteria 

responsible for the disease fire blight. 

After having reviewed the submission, 

EPA determined that emergency 

conditions exist for this State, and that 

the criteria for an emergency exemption 

are met. EPA has authorized under 

FIFRA section 18 the use of 

kasugamycin on apples for control of 

fire blight in Michigan. 

As part of its evaluation of the 

emergency exemption application, EPA 

assessed the potential risks presented by 

residues of kasugamycin in or on 

apples. In doing so, EPA considered the 

safety standard in section 408(b)(2) of 

FFDCA, and EPA decided that the 

necessary tolerance 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 

exemption in order to address an urgent 

non-routine situation and to ensure that 

the resulting food is safe and lawful, 

EPA is issuing this tolerance 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, 2012, under 

section 408(l)(5) of FFDCA, residues of 

the pesticide not in excess of the 

amounts specified in the tolerance 

remaining in or on apples 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 kasugamycin 

meets FIFRA’s registration requirements 

for use on apples or whether permanent 

tolerances for this use would be 

appropriate. Under these circumstances, 

EPA does not believe that this timelimited tolerance decision serves as a 

basis for registration of kasugamycin by 

a State for special local needs under 

FIFRA section 24(c). Nor does this 

tolerance serve as the basis for persons 

in any State other than Michigan to use 

this pesticide on these crops under 

FIFRA section 18 absent the issuance of 

an emergency exemption applicable 

within that State. For additional 

information regarding the emergency 

exemption for kasugamycin, 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 


jlentini on DSKJ8SOYB1PROD with RULES
19270 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

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 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 expected as a result 

of this emergency exemption request 

and the time-limited tolerances for 

residues of kasugamycin, 3-O-[2-amino4-[(carboxyiminomethyl)amino]-2,3,4,6- 

tetradeoxy-a-D-arabino-hexopyranosyl]- 

D-chiro-inositol on apples at 0.05 ppm. 

EPA’s assessment of exposures and risks 

associated with establishing timelimited 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 kasugamycin used for 

human risk assessment can be found at 

http://www.regulations.gov in document 

‘‘Kasugamycin. Human Health Risk 

Assessment for the Proposed Food/Feed 

Use of the Fungicide (Associated with 

Section 18 Registration) on Apples in 

Michigan,’’ page 8 in docket ID number 

EPA–HQ–OPP–2008–0695. On page 9 of 

that assessment there is also a 

qualitative evaluation of the risks for 

development of resistant pathogenic 

bacteria, in consideration of factors 

recommended by public health experts 

to sustain the effectiveness of antibiotic 

materials. Field use of this chemical 

under the section 18 involved measures 

and requirements to limit, manage, and 

monitor for resistant bacteria. The terms 

of use are included in this docket. 

B. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. In evaluating dietary 

exposure to kasugamycin, EPA 

considered exposure under the timelimited tolerances established by this 

action as well as all existing 

kasugamycin tolerances in (40 CFR 

180.614). EPA assessed dietary 

exposures from kasugamycin in food as 

follows: 

i. Acute exposure. No such effects 

were identified in the toxicological 

studies for kasugamycin; 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 USDA 1994–1996 and 1998 

CSFII. As to residue levels in food, EPA 

assumed 100 percent crop treated (PCT) 

and default processing factors were 

used. The chronic dietary assessment is 

highly conservative, and therefore 

provides an upper-bound estimate of 

dietary exposure and risk. 

iii. Cancer. Kasugamycin has been 

classified by the Agency as not likely to 

be carcinogenic to humans and 

therefore, a cancer exposure assessment 

was not conducted. 

iv. Anticipated residue and PCT 

information. EPA did not use 

anticipated residue and/or PCT 

information in the dietary assessment 

for kasugamycin. Tolerance level 

residues and/or 100 PCT were assumed 

for all food commodities. 

2. Dietary exposure from drinking 

water. The Agency used screening level 

water exposure models in the dietary 

exposure analysis and risk assessment 

for kasugamycin in drinking water. 

These simulation models take into 

account data on the physical, chemical, 

and fate/transport characteristics of 

kasugamycin. 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) and Screening 

Concentration in Ground Water (SCIGROW) models, the estimated drinking 

water concentrations (EDWCs) of 

kasugamycin for chronic exposures for 

non-cancer assessments are estimated to 

be 0.0214 ppb for surface water and 

0.278 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 0.278 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). 

Kasugamycin is not registered for any 

specific use patterns 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.’’ 

EPA has not found kasugamycin to 

share a common mechanism of toxicity 

with any other substances, and 

kasugamycin does not appear to 

produce a toxic metabolite produced by 

other substances. For the purposes of 

this tolerance action, therefore, EPA has 

assumed that kasugamycin 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 


jlentini on DSKJ8SOYB1PROD with RULES
Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 19271 

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 

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. 

No increased quantitative or qualitative 

susceptibility was observed in the 

developmental rat or rabbit studies or in 

the 2–generation reproduction study. No 

offspring toxicity was observed at any of 

the doses tested in these three studies. 

Reproductive toxicity was noted in the 

F1 generation of the 2–generation 

reproduction study. However, because 

parental toxicity (decreased body 

weights and body weight gains) 

occurred at a lower dose than that 

which resulted in effects on 

reproduction, there is no increased 

quantitative or qualitative susceptibility 

of the offspring. 

3. Conclusion. There was no evidence 

of neurotoxicity in any of the studies 

available in the toxicology database, 

including the subchronic feeding 

studies, the chronic feeding studies, the 

developmental toxicity studies, and the 

2–generation reproduction study. 

Therefore, acute and subchronic 

neurotoxicity studies are not required. A 

developmental neurotoxicity study is 

not required because: 

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 

kasugamycin is considered adequate to 

characterize potential toxic effects on 

infants and children. 

ii. There is no indication that 

kasugamycin is a neurotoxic chemical 

and there is no need for a 

developmental neurotoxicity study or 

additional UFs to account for 

neurotoxicity. 

iii. There is no evidence that 

kasugamycin results in increased 

susceptibility in in utero rats or rabbits 

in the prenatal developmental studies or 

in young rats in the 2–generation 

reproduction study. 

iv. There are no residual uncertainties 

identified in the exposure databases. 

The dietary food exposure assessments 

were performed based on 100 PCT and 

tolerance-level residues. EPA made 

conservative (protective) assumptions in 

the ground and surface water modeling 

used to assess exposure to kasugamycin 

in drinking water. These assessments 

will not underestimate the exposure and 

risks posed by kasugamycin. 

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. No adverse effect resulting from 

a single-oral exposure was identified, 

therefore, no acute dietary endpoint was 

selected. Therefore, kasugamycin 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 chronic exposure to kasugamycin 

from food and water will utilize 20% of 

the cPAD for all infants less than 1 year 

old, the population group receiving the 

greatest exposure. There are no 

residential uses for kasugamycin. 

3. Short-and intermediate term risk. 

Short- and intermediate-term aggregate 

exposure take into account short- and 

intermediate-term residential exposure 

plus chronic exposure to food and water 

(considered to be a background 

exposure level). 

Kasugamycin is not registered for any 

use patterns that would result in 

residential exposure. Therefore, the 

short- and intermediate-term aggregate 

risk is the sum of the risk from exposure 

to kasugamycin through food and water 

and will not be greater than the chronic 

aggregate risk. 

4. Aggregate cancer risk for U.S. 

population. Kasugamycin is classified as 

a not likely to be carcinogenic to 

humans, and therefore, EPA does not 

expect kasugamycin to pose a cancer 

risk. 

5. Determination of safety. Based on 

these risk assessments, EPA concludes 

that there is a reasonable certainty that 

no harm will result to the general 

population, or to infants and children, 

from aggregate exposure to kasugamycin 

residues. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

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 established Canadian, 

Mexican, or Codex Maximum Residue 

Limits (MRLs) for kasugamycin residues 

in apple commodities. 

VI. Conclusion 

Therefore, a time-limited tolerance is 

established for residues of kasugamycin, 

3-O-[2-amino-4- 

[(carboxyiminomethyl)amino]-2,3,4,6- 

tetradeoxy-a-D-arabino-hexopyranosyl]- 

D-chiro-inositol in or on apples at 0.05 

ppm. This tolerance expires and is 

revoked on December 31, 2012. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under sections 408(e) and 408(l)(6) of 

FFDCA. 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 


jlentini on DSKJ8SOYB1PROD with RULES
19272 Federal Register / Vol. 75, No. 71 / Wednesday, April 14, 2010 / Rules and Regulations 

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 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). 

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: April 1, 2010. 

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 180.614 is amended by 

revising paragraph (b) to read as follows: 

§ 180.614 Kasugamycin; tolerances for 

residues. 

* * * * * 

(b) Section 18 emergency exemptions. 

Time-limited tolerances specified in the 

following table are established for 

residues of kasugamycin, 3-O-[2-amino4-[(carboxyiminomethyl)amino]-2,3,4,6- 

tetradeoxy-a-D-arabino-hexopyranosyl]- 

D-chiro-inositol 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. 

Commodity Parts per million 

Expiration/ 

revocation 

date 

Apple 0.05 12/31/12 

* * * * * 

[FR Doc. 2010–8133 Filed 4–13–10; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0134; FRL–8818-9] 

Thifensulfuron methyl; Pesticide 

Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

tolerance for residues of thifensulfuron 

methyl in or on safflower, seed. 

Interregional Research Project Number 4 

(IR-4) requested this tolerance under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective April 

14, 2010. Objections and requests for 

hearings must be received on or before 

June 14, 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–2009–0134. 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: 

Barbara Madden, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–6463; e-mail address: 

madden.barbara@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 


jlentini on DSKJ8SOYB1PROD with RULES