Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 53721 

Dated: August 18, 2008. 

Ira W. Leighton, 

Acting Regional Administrator, EPA New 

England. 

■ For the reasons stated in the preamble, 

title 40, chapter I of the Code of Federal 

Regulations, is amended as follows: 

PART 55—[AMENDED] 

■ 1. The authority citation for part 55 

continues to read as follows: 

Authority: Section 328 of the Act (42 

U.S.C. 7401, et seq.) as amended by Public 

Law 101–549. 

■ 2. Section 55.14 is amended as 

follows: 

■ a. By adding paragraph (d)(11). 

■ b. In paragraph (e) introductory text 

by adding a new address after the words 

‘‘regional offices:’’. 

■ c. By adding paragraph (e)(11). 

§ 55.14 Requirements that apply to OCS 

sources located within 25 miles of States’ 

seaward boundaries, by State. 

* * * * * 

(d) * * * 

(11) Massachusetts. 

(i) 40 CFR part 52, subpart W. 

(ii) [Reserved] 

* * * * * 

(e) * * * U.S.EPA, Region 1 

(Massachusetts) One Congress Street, 

Boston, MA 02114–2023 * * * 

* * * * * 

(11) Massachusetts. 

(i) State requirements. 

(A) Commonwealth of Massachusetts 

Requirements Applicable to OCS 

Sources, December 28, 2007. 

(B) [Reserved] 

(ii) Local requirements. 

(A) [Reserved] 

* * * * * 

■ 3. Appendix A to CFR part 55 is 

amended by adding an entry for 

Massachusetts in alphabetical order to 

read as follows: 

Appendix A to Part 55—Listing of State 

and Local Requirements Incorporated 

by Reference Into Part 55, by State 

* * * * * 

Massachusetts 

(a) State requirements. 

(1) The following Commonwealth of 

Massachusetts requirements are applicable to 

OCS Sources, December 28, 2007, 

Commonwealth of Massachusetts— 

Department of Environmental Protection. The 

following sections of 310 CMR 4.00, 310 

CMR 6.00, 310 CMR 7.00 and 310 CMR 8.00: 

310 CMR 4.00: Timely Action Schedule and 

Fee Provisions 

Section 4.01: Purpose, Authority and General 

Provisions (Effective 10/19/2007) 

Section 4.02: Definitions (Effective 10/19/ 

2007) 

Section 4.03: Annual Compliance Assurance 

Fee (Effective 10/19/2007) 

310 CMR 6.00: Ambient Air Quality 

Standards for the Commonwealth of 

Massachusetts 

Section 6.01: Definitions (Effective 12/28/ 

2007) 

Section 6.02: Scope (Effective 12/28/2007) 

Section 6.03: Reference Conditions (Effective 

12/28/2007) 

Section 6.04: Standards (Effective 12/28/ 

2007) 

310 CMR 7.00: Air Pollution Control 

Section 7.00: Statutory Authority; Legend; 

Preamble; Definitions (Effective 12/28/ 

2007) 

Section 7.01: General Regulations to Prevent 

Air Pollution (Effective 12/28/2007) 

Section 7.02: U Plan Approval and Emission 

Limitations (Effective 12/28/2007) 

Section 7.03: U Plan Approval Exemptions: 

Construction Requirements (Effective 12/ 

28/2007) 

Section 7.04: U Fossil Fuel Utilization 

Facilities (Effective 12/28/2007) 

Section 7.05: U Fuels All Districts (Effective 

12/28/2007) 

Section 7.06: U Visible Emissions (Effective 

12/28/2007) 

Section 7.07: U Open Burning (Effective 12/ 

28/2007) 

Section 7.08: U Incinerators (Effective 12/28/ 

2007) 

Section 7.09: U Dust, Odor, Construction and 

Demolition (Effective 12/28/2007) 

Section 7.11: U Transportation Media 

(Effective 12/28/2007) 

Section 7.12: U Source Registration (Effective 

12/28/2007) 

Section 7.13: U Stack Testing (Effective 12/ 

28/2007) 

Section 7.14: U Monitoring Devices and 

Reports (Effective 12/28/2007) 

Section 7.15: U Asbestos (Effective 12/28/ 

2007) 

Section 7.18: U Volatile and Halogenated 

Organic Compounds (Effective 12/28/2007) 

Section 7.19: U Reasonably Available Control 

Technology (RACT) for Sources of Oxides 

of Nitrogen (NOX) (Effective 12/28/2007) 

Section 7.21: Sulfur Dioxide Emissions 

Limitations (Effective 12/28/2007) 

Section 7.22: Sulfur Dioxide Emissions 

Reductions for the Purpose of Reducing 

Acid Rain (Effective 12/28/2007) 

Section 7.24: U Organic Material Storage and 

Distribution (Effective 12/28/2007) 

Section 7.25: U Best Available Controls for 

Consumer and Commercial Products 

(Effective 12/28/2007) 

Section 7.26: Industry Performance 

Standards (Effective 12/28/2007) 

Section 7.27: NOX Allowance Program 

(Effective 12/28/2007) 

Section 7.28: NOX Allowance Trading 

Program (Effective 12/28/2007) 

Section 7.29: Emissions Standards for Power 

Plants (Effective 12/28/2007) 

Section 7.60: U Severability (Effective 12/28/ 

2007) 

Section 7.00: Appendix A (Effective 12/28/ 

2007) 

Section 7.00: Appendix B (Effective 12/28/ 

2007) 

Section 7.00: Appendix C (Effective 12/28/ 

2007) 

310 CMR 8.00: The Prevention and/or 

Abatement of Air Pollution Episode and Air 

Pollution Incident Emergencies 

Section 8.01: Introduction (Effective 12/28/ 

2007) 

Section 8.02: Definitions (Effective 12/28/ 

2007) 

Section 8.03: Air Pollution Episode Criteria 

(Effective 12/28/2007) 

Section 8.04: Air Pollution Episode Potential 

Advisories (Effective 12/28/2007) 

Section 8.05: Declaration of Air Pollution 

Episodes and Incidents (Effective 12/28/ 

2007) 

Section 8.06: Termination of Air Pollution 

Episodes and Incident Emergencies 

(Effective 12/28/2007) 

Section 8.07: Emission Reductions Strategies 

(Effective 12/28/2007) 

Section 8.08: Emission Reduction Plans 

(Effective 12/28/2007) 

Section 8.15: Air Pollution Incident 

Emergency (Effective 12/28/2007) 

Section 8.30: Severability (Effective 12/28/ 

2007) 

(2) [Reserved] 

* * * * * 

[FR Doc. E8–21486 Filed 9–16–08; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2006–0791; FRL–8374–1] 

Inert Ingredient: Exemption From the 

Requirement of a Tolerance for 

amylopectin, acid-hydrolyzed, 

1-octenylbutanedioate and for 

amylopectin, hydrogen 

1-octadecenylbutanedioate 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

exemptions from the requirement of a 

tolerance for residues of amylopectin, 

acid-hydrolyzed, 1-octenylbutanedioate 

(CAS Reg. No. 113894–85–2) and for 

amylopectin, hydrogen 1- 

octadecenylbutanedioate (CAS Reg. No. 

125109–81–1) when used in 

antimicrobial formulations (food-contact 

surface sanitizing solutions) under 40 

CFR 180.940(a), and when used in 

accordance with good agricultural or 

manufacturing practice under 40 CFR 

180.950. The petitioner, Lewis & 

Harrison, LLC, on behalf of Alco 

Chemical, submitted a petition to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), as amended by 

the Food Quality Protection Act of 1996 

(FQPA), requesting an exemption from 

the requirement of a tolerance. This 

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53722 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of amylopectin, acidhydrolyzed, 1-octenylbutanedioate and 

amylopectin, hydrogen 1- 

octadecenylbutanedioate. 

DATES: This regulation is effective 

September 17, 2008. Objections and 

requests for hearings must be received 

on or before November 17, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2006–0791. To access the 

electronic docket, go to http:// 

www.regulations.gov, select ‘‘Advanced 

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

the docket ID number where indicated 

and select the ‘‘Submit’’ button. Follow 

the instructions on the regulations.gov 

website to view the docket index or 

access available documents. All 

documents in the docket are listed in 

the docket index available in 

regulations.gov. Although listed in the 

index, some information is not publicly 

available, e.g., Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Certain other material, such as 

copyrighted material, is not placed on 

the Internet and will be publicly 

available only in hard copy form. 

Publicly available docket materials are 

available either in the electronic docket 

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

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: 

Karen Samek, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8825; e-mail address: 

samek.karen@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 Access Electronic Copies 

of this Document? 

In addition to accessing an electronic 

copy of this Federal Register document 

through the electronic docket at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of 40 CFR part 180 

through the Government Printing 

Office’s pilot e-CFR site at http:// 

www.gpoaccess.gov/ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, as 

amended by FQPA, any person may file 

an objection to any aspect of this 

regulation and may also request a 

hearing on those objections. The EPA 

procedural regulations which govern the 

submission of objections and requests 

for hearings appear in 40 CFR part 178. 

You must file your objection or request 

a hearing on this regulation in 

accordance with the instructions 

provided in 40 CFR part 178. To ensure 

proper receipt by EPA, you must 

identify docket ID number EPA–HQ– 

OPP–2006–0791 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 November 17, 2008. 

In addition to filing an objection or 

hearing request with the Hearing Clerk 

as described in 40 CFR part 178, please 

submit a copy of the filing that does not 

contain any CBI for inclusion in the 

public docket that is described in 

ADDRESSES. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit your 

copies, identified by docket ID number 

EPA–HQ–OPP–2006–0791, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW. Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket’s 

normal hours of operation (8:30 a.m. to 

4 p.m., Monday through Friday, 

excluding legal holidays). Special 

arrangements should be made for 

deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of December 

20, 2006 (71 FR 76321) (FRL–8104–4), 

EPA issued a notice pursuant to section 

408 of FFDCA, 21 U.S.C. 346a, as 

amended by FQPA (Public Law 104– 

170), announcing the filing of a 

pesticide petition (PP 6E7083) by Lewis 

& Harrison, LLC, on behalf of Alco 

Chemical, 122 C St., NW., Suite 740, 

Washington, DC 20001. The petition 

requested that 40 CFR 180.940(a) and 40 

CFR 180.950 be amended by 

establishing exemptions from the 

requirement of a tolerance for residues 

of amylopectin, acid-hydrolyzed, 1- 

octenylbutanedioate (CAS Reg. No. 

113894–85–2) and amylopectin, 

hydrogen 1-octadecenylbutanedioate 

(CAS Reg. No. 125109–81–1) when used 

in antimicrobial formulations (foodcontact surface sanitizing solutions) 

under 40 CFR 180.940(a) and when used 

in accordance with good agricultural or 

manufacturing practice under 40 CFR 

180.950. That notice included a 

summary of the petition prepared by the 

petitioner. There were no comments 

received in response to the notice of 

filing. For ease of reading in this 

document amylopectin, acidhydrolyzed, 1-octenylbutanedioate (CAS 

Reg. No. 113894–85–2) and 

amylopectin, hydrogen 1- 

octadecenylbutanedioate (CAS Reg. No. 

125109–81–1) are referred to as starch 

octenylsuccinates. 

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

allows EPA to establish an exemption 

from the requirement for a tolerance (the 

legal limit for a pesticide chemical 

residue in or on a food) only if EPA 

determines that the tolerance is ‘‘safe.’’ 

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Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 53723 

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. . . .’’ 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. First, 

EPA determines the toxicity of 

pesticides. Second, EPA examines 

exposure to the pesticide through food, 

drinking water, and through other 

exposures that occur as a result of 

pesticide use in residential settings. 

III. Toxicological Profile 

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

of FFDCA, EPA has reviewed the 

available scientific data and other 

relevant information in support of this 

action and considered its validity, 

completeness and reliability and the 

relationship of this information 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. The 

nature of the toxic effects caused by 

starch octenylsuccinates are discussed 

in this unit. 

The following provides a brief 

summary of the risk assessment and 

conclusions for the Agency’s review of 

starch octenylsuccinates. The Agency’s 

full decision document for this action is 

available in EPA’s Electronic Docket at 

http://www.regulations.gov, under 

docket number EPA–HQ–OPP–2006– 

0791. 

The toxicity database is sufficient for 

starch octenylsuccinates. In terms of 

hazard, there are low concerns 

(practically non-toxic). In subchronic 

and chronic toxicity feeding studies in 

rats, the results show that the 

compound does not produce 

compound-related effects at dietary 

concentrations as high as 30% of the 

diet (equivalent to 15 gram/kilogram/ 

day (g/kg/day)). While no neurotoxicity 

studies where submitted, neurotoxicity 

was not observed in the dietary studies 

at concentrations as high as 30% (15 g/ 

day) of the test material. The compound 

does not suggest increased toxicity in 

young rats and all the mutagenicity 

testing results were negative. The 

metabolism data showed that with oral 

dosing in dogs, 14C-octenylsuccinate 

was absorbed and eliminated via the 

urine and feces. The major route of 

elimination was via urine (62–72% of 

the administered radioactivity). No 

developmental toxicity studies are 

available in the data base. However, in 

the dietary study conducted in rats fed 

octenylsuccinate modified starch during 

gestation through post-natal day 90 at 

doses up to 30% (15 g/day), there was 

no systemic toxicity in female rats and 

their offspring. 

Furthermore, it should be noted that 

starch octenylsuccinate anhydride is 

currently permitted by the U.S. Food 

and Drug Administration (FDA) as a 

direct food additive under 21 CFR 

172.892. 

IV. Aggregate Exposures 

In examining aggregate exposure, 

section 408 of FFDCA directs EPA to 

consider available information 

concerning exposures from the pesticide 

residue in food and all other nonoccupational exposures, including 

drinking water from ground water or 

surface water and exposure through 

pesticide use in gardens, lawns, or 

buildings (residential and other indoor 

uses). 

For dietary exposures, application of 

starch octenylsuccinates to food 

(including crops, meats, and fish) as 

inert ingredients in pesticide products is 

not expected to result in significant 

human exposure to starch 

octenylsuccinates residues considering 

their rapid biodegradation in soil and 

water and lack of persistence in the 

environment. For the same reason, 

significant drinking water exposures 

from the use of these chemicals as inert 

ingredients in pesticide formulations are 

not anticipated. 

In evaluating the potential for 

exposure from the use of starch 

octenylsuccinates in residential 

pesticide products, inhalation exposures 

are not anticipated since the compounds 

are not likely to volatize and are not 

expected to be absorbed via inhalation 

due to their large particle size. It is 

expected that dermal exposure is the 

primary route of exposure; however, 

based on their molecular weight, these 

chemicals are not likely to be absorbed 

via the dermal route. Therefore, there is 

no concern for dermal exposure. 

Starch octenylsuccinates are widely 

used in a variety of consumer products. 

An aggregate assessment for starch 

octenylsuccinates was not conducted 

because the exposures to the chemicals 

by non-pesticide consumer products are 

not likely to result in significant 

residues of concern. Furthermore, starch 

octenylsuccinates are used as food 

additives and are normal constituents of 

the human diet. 

V. Cumulative Effects 

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.’’ Unlike other 

pesticides for which EPA has followed 

a cumulative risk approach based on a 

common mechanism of toxicity, EPA 

has not made a common mechanism of 

toxicity finding as to starch 

octenylsuccinates and any other 

substances and, these materials do not 

appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has not assumed that 

starch octenylsuccinates 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/. 

VI. Safety Factor for Infants and 

Children 

Section 408 of the FFDCA provides 

that EPA shall apply an additional 

tenfold margin of safety for infants and 

children in the case of threshold effects 

to account for prenatal and postnatal 

toxicity and the completeness of the 

database on toxicity and exposure 

unless EPA determines that a different 

margin of safety will be safe for infants 

and children. Margins of safety are 

incorporated into EPA risk assessments 

either directly through use of a MOE 

analysis or through using uncertainty 

(safety) factors in calculating a dose 

level that poses no appreciable risk to 

humans. The toxicity database is 

sufficient for starch octenylsuccinates 

and potential exposure is adequately 

characterized given the low toxicity of 

starch octenylsuccinates. In terms of 

hazard, there are low concerns 

(practically non-toxic) and no residual 

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53724 Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 

uncertainties regarding prenatal and/or 

postnatal toxicity. No developmental 

toxicity studies are available in the data 

base. However, in the dietary study 

conducted in rats fed octenylsuccinate 

modified starch during gestation 

through post-natal day 90 at doses up to 

30% (15 g/day), there was no systemic 

toxicity in female rats and their 

offspring. Based on lack of any systemic 

toxicity at doses up to 15 g/day in rats, 

lack of any apparent developmental 

effects, and lack of any systemic toxicity 

in weanlings at doses up to 15 g/day, 

EPA concluded that there is no evidence 

of increased susceptibility to infants and 

children. Given the low toxicity of 

starch octenylsuccinates, a safety factor 

analysis has not been used to assess 

risk. For similar reasons, including the 

lack of any concern regarding increased 

sensitivity in the young, the additional 

10X FQPA safety factor for protection of 

infants and children is not necessary. 

VII. Determination of Safety 

The toxicity database is sufficient for 

the risk assessment of starch 

octenylsuccinates as specified. In terms 

of hazard, there are low concerns 

(practically non-toxic). The toxicity 

database does not indicate susceptibility 

in fetuses, thus there is no concern at 

this time for increased sensitivity to 

infants and children to starch 

octenylsuccinates when used as 

ingredients in pesticide formulations. 

Dietary (food and drinking water) 

exposures of concern are not anticipated 

from the use of starch octenylsuccinate 

as inert ingredients in pesticide and 

non-pesticide products, considering 

their rapid biodegradation in soil and 

water and lack of persistence in the 

environment. Inhalation and dermal 

exposures of concern from the use of 

these chemicals as inert ingredients in 

pesticide products in residential settings 

are not anticipated because these 

compounds are not likely to volatize 

and are not expected to be absorbed due 

to their large particle size. 

Considering their low toxicity 

(practically non-toxic), ready 

biodegradation in soil and water, and 

lack of persistence in the environment, 

it is unlikely that dietary and residential 

exposures of concern would result from 

the use of starch octenylsuccinates as 

ingredients in pesticides. An aggregate 

assessment for starch octenylsuccinates 

was not conducted because the 

exposures to the chemicals by nonpesticide consumer products are not 

likely to result in significant residues of 

concern. 

Based on this information, EPA 

concludes that starch octenylsuccinates 

do not pose a risk to the general 

population, or to infants and children, 

under reasonably foreseeable 

circumstances. Therefore, EPA finds 

that the exemptions from the 

requirement of a tolerance for 

amylopectin, acid-hydrolyzed, 1- 

octenylbutanedioate (CAS Reg. No. 

113894–85–2) and for amylopectin, 

hydrogen 1-octadecenylbutanedioate 

(CAS Reg. No. 125109–81–1) when used 

in antimicrobial formulations (foodcontact surface sanitizing solutions) 

under 40 CFR 180.940(a), and when 

used in accordance with good 

agricultural or manufacturing practice 

under 40 CFR 180.950 will be safe 

under section 408(c) of FFDCA and is 

granting the requested tolerance 

exemptions. 

VIII. Other Considerations 

A. Analytical Method 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Tolerances 

The Agency is not aware of any 

country requiring a tolerance for 

amylopectin, acid-hydrolyzed, 1- 

octenylbutanedioate (CAS Reg. No. 

113894–85–2) and for amylopectin, 

hydrogen 1-octadecenylbutanedioate 

(CAS Reg. No. 125109–81–1) nor have 

any CODEX Maximum Residue Levels 

(MRLs) been established for any food 

crops at this time. 

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, 

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). 

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Federal Register / Vol. 73, No. 181 / Wednesday, September 17, 2008 / Rules and Regulations 53725 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: September 4, 2008. 

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 180.940 is amended by 

alphabetically adding entries to the 

table in paragraph (a) to read as follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food-contact 

surface sanitizing solutions). 

(a) * * * 

Pesticide Chemical CAS Reg. No. Limits 

* * * * * * * 

Amylopectin, acid-hydrolyzed, 1-oxtenylbutanedioate ............................................................ 113894–85–2 none

Amylopectin, hydrogen 1-octadecenylbutanedioate ................................................................ 125109–81–1 none

* * * * * * * 

* * * * * 

■ 3. Section 180.950 is amended by 

alphabetically adding entries to the 

table in paragraph (e) to read as follows: 

§ 180.950 Tolerance exemptions for 

minimal risk active and inert ingredients. 

* * * * * 

(e) * * * 

Chemical CAS No. 

* * * * * 

Amylopectin, acidhydrolyzed, 1- 

octenylbutanedioate .... 113894–85–2 

Amylopectin, hydrogen 1- 

octadecenylbutanedioate ............................... 125109–81–1 

* * * * * 

[FR Doc. E8–21737 Filed 9–16–08; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2007–0894; FRL–8382–6] 

Ethoprop; Pesticide Tolerances 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes 

tolerances for residues of ethoprop in or 

on hop, dried cones; peppermint, tops; 

and spearmint, tops. Interregional 

Research Project Number 4 (IR-4) 

requested these tolerances under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA). 

DATES: This regulation is effective 

September 17, 2008. Objections and 

requests for hearings must be received 

on or before November 17, 2008, and 

must be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2007–0894. 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: 

Susan Stanton, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–5218; e-mail address: 

stanton.susan@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 Access Electronic Copies 

of this Document? 

In addition to accessing electronically 

available documents at http:// 

www.regulations.gov, you may access 

this Federal Register document 

electronically through the EPA Internet 

under the ‘‘Federal Register’’ listings at 

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

also access a frequently updated 

electronic version of EPA’s tolerance 

regulations at 40 CFR part 180 through 

the Government Printing Office’s pilot 

e-CFR site at http://www.gpoaccess.gov/ 

ecfr. 

C. Can I File an Objection or Hearing 

Request? 

Under section 408(g) of FFDCA, 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 

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