51470 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 

Express Mail Contract 3 (MC2009–15 and 

CP2009–21) 

Express Mail Contract 4 (MC2009–34 and 

CP2009–45) 

Express Mail & Priority Mail Contract 1 

(MC2009–6 and CP2009–7) 

Express Mail & Priority Mail Contract 2 

(MC2009–12 and CP2009–14) 

Express Mail & Priority Mail Contract 3 

(MC2009–13 and CP2009–17) 

Express Mail & Priority Mail Contract 4 

(MC2009–17 and CP2009–24) 

Express Mail & Priority Mail Contract 5 

(MC2009–18 and CP2009–25) 

Express Mail & Priority Mail Contract 6 

(MC2009–31 and CP2009–42) 

Express Mail & Priority Mail Contract 7 

(MC2009–32 and CP2009–43) 

Express Mail & Priority Mail Contract 8 

(MC2009–33 and CP2009–44) 

Parcel Select & Parcel Return Service 

Contract 2 (MC2009–40 and CP2009–61) 

Parcel Return Service Contract 1 (MC2009– 

1 and CP2009–2) 

Priority Mail Contract 1 (MC2008–8 and 

CP2008–26) 

Priority Mail Contract 2 (MC2009–2 and 

CP2009–3) 

Priority Mail Contract 3 (MC2009–4 and 

CP2009–5) 

Priority Mail Contract 4 (MC2009–5 and 

CP2009–6) 

Priority Mail Contract 5 (MC2009–21 and 

CP2009–26) 

Priority Mail Contract 6 (MC2009–25 and 

CP2009–30) 

Priority Mail Contract 7 (MC2009–25 and 

CP2009–31) 

Priority Mail Contract 8 (MC2009–25 and 

CP2009–32) 

Priority Mail Contract 9 (MC2009–25 and 

CP2009–33) 

Priority Mail Contract 10 (MC2009–25 and 

CP2009–34) 

Priority Mail Contract 11 (MC2009–27 and 

CP2009–37) 

Priority Mail Contract 12 (MC2009–28 and 

CP2009–38) 

Priority Mail Contract 13 (MC2009–29 and 

CP2009–39) 

Priority Mail Contract 14 (MC2009–30 and 

CP2009–40) 

Priority Mail Contract 15 (MC2009–35 and 

CP2009–54) 

Priority Mail Contract 16 (MC2009–36 and 

CP2009–55) 

Priority Mail Contract 17 (MC2009–37 and 

CP2009–56) 

Priority Mail Contract 18 (MC2009–42 and 

CP2009–63) 

Outbound International 

Direct Entry Parcels Contracts 

Direct Entry Parcels 1 (MC2009–26 and 

CP2009–36) 

Global Direct Contracts (MC2009–9, 

CP2009–10, and CP2009–11) 

Global Expedited Package Services (GEPS) 

Contracts 

GEPS 1 (CP2008–5, CP2008–11, CP2008– 

12, and CP2008–13, 

CP2008–18, CP2008–19, CP2008–20, 

CP2008–21, CP2008–22, CP2008–23, and 

CP2008–24) 

Global Expedited Package Services 2 

(CP2009–50) 

Global Plus Contracts 

Global Plus 1 (CP2008–8, CP2008–46 and 

CP2009–47) 

Global Plus 2 (MC2008–7, CP2008–48 and 

CP2008–49) 

Inbound International 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 

(MC2008–6, CP2008–14 and MC2008–15) 

Inbound Direct Entry Contracts with 

Foreign Postal Administrations 

1 (MC2008–6 and CP2009–62) 

International Business Reply Service 

Competitive Contract 1 (MC2009–14 and 

CP2009–20) 

Competitive Product Descriptions 

Express Mail 

[Reserved for Group Description] 

Express Mail 

[Reserved for Product Description] 

Outbound International Expedited Services 

[Reserved for Product Description] 

Inbound International Expedited Services 

[Reserved for Product Description] 

Priority 

[Reserved for Product Description] 

Priority Mail 

[Reserved for Product Description] 

Outbound Priority Mail International 

[Reserved for Product Description] 

Inbound Air Parcel Post 

[Reserved for Product Description] 

Parcel Select 

[Reserved for Group Description] 

Parcel Return Service 

[Reserved for Group Description] 

International 

[Reserved for Group Description] 

International Priority Airlift (IPA) 

[Reserved for Product Description] 

International Surface Airlift (ISAL) 

[Reserved for Product Description] 

International Direct Sacks—M–Bags 

[Reserved for Product Description] 

Global Customized Shipping Services 

[Reserved for Product Description] 

International Money Transfer Service 

[Reserved for Product Description] 

Inbound Surface Parcel Post (at non-UPU 

rates) 

[Reserved for Product Description] 

International Ancillary Services 

[Reserved for Product Description] 

International Certificate of Mailing 

[Reserved for Product Description] 

International Registered Mail 

[Reserved for Product Description] 

International Return Receipt 

[Reserved for Product Description] 

International Restricted Delivery 

[Reserved for Product Description] 

International Insurance 

[Reserved for Product Description] 

Negotiated Service Agreements 

[Reserved for Group Description] 

Domestic 

[Reserved for Product Description] 

Outbound International 

[Reserved for Group Description] 

Part C—Glossary of Terms and Conditions 

[Reserved] 

Part D—Country Price Lists for International 

Mail [Reserved] 

[FR Doc. E9–24237 Filed 10–6–09; 8:45 am] 

BILLING CODE 7710–FW–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0490; FRL–8439–1] 

Sodium and Ammonium 

Naphthalenesulfonate Formaldehyde 

Condensates; Exemption from the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of the sodium and 

ammonium napthalenesulfonate 

formaldehyde condensates, herein 

referred to in this document as the 

SANFCs, when used as inert ingredients 

in pesticide formulations applied preharvest and post-harvest. The Joint 

Inerts Task Force (JITF), Cluster Support 

Team Number 11 and Akzo Nobel 

Surface Chemistry, LLC, submitted 

petitions to EPA under the Federal 

Food, Drug, and Cosmetic Act (FFDCA), 

requesting an exemption from the 

requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of the SANFCs. 

DATES: This regulation is effective 

October 7, 2009. Objections and 

requests for hearings must be received 

on or before December 7, 2009, 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–2009–0490. 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 


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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: 

Elizabeth Fertich, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8560; e-mail address: 

fertich.elizabeth@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 e-CFR 

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

To access the OPPTS Harmonized 

Guidelines referenced in this document, 

go directly to the guidelines at http:// 

www.epa.gov/opptsfrs/home/ 

guidelin.htm. 

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–2009–0490 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 December 7, 2009. 

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–2009–0490, 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 

In the Federal Register of August 19, 

2009 (74 FR 41898) (FRL–8426–7), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide petition (PP 9E7572) by The 

JITF, CST 11, c/o CropLife America, 

1156 15th Street, NW., Suite 400, 

Washington, DC 20005. The petition 

requested that 40 CFR 180.910 be 

amended by establishing exemptions 

from the requirement of a tolerance for 

residues of SANFCs. That notice 

referenced a summary of the petition 

prepared by the JITF, CST 11, the 

petitioner, which is available to the 

public in the docket, http:// 

www.regulations.gov. Docket ID number 

EPA–HQ–OPP–2009–0043 was 

established for this petition. There were 

no comments received in response to 

the notice of filing. 

In the Federal Register of August 19, 

2009 (74 FR 41895]) (FRL–8429–9), 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 9E7562) by Akzo 

Nobel Surface Chemistry, LLC, 525 West 

Van Buren Street, Chicago, IL 60607– 

3823. The petition requested that 40 

CFR 180.910 be amended by 

establishing exemptions from the 

requirement of a tolerance for residues 

of mono-, di-, and 

trimethylnapthalenesulfonic acids and 

napthalenesulfonic acids formaldehyde 

condensates, ammonium and sodium 

salts. That notice referenced a summary 

of the petition prepared by Akzo Nobel 

Surface Chemistry, LLC, the petitioner, 

which is available to the public in the 

docket, http://www.regulations.gov. 

Docket ID number EPA–HQ–OPP–2008– 

0822 was established for this petition. 

There were no comments received in 

response to the notice of filing. 

These two petitions are grouped 

because they fall under the same general 

chemical description criteria. 

III. Inert Ingredient Definition 

Inert ingredients are all ingredients 

that are not active ingredients as defined 

in 40 CFR 153.125 and include, but are 

not limited to, the following types of 

ingredients (except when they have a 

pesticidal efficacy of their own): 

Solvents such as alcohols and 

hydrocarbons; surfactants such as 

polyoxyethylene polymers and fatty 

acids; carriers such as clay and 

diatomaceous earth; thickeners such as 

carrageenan and modified cellulose; 

wetting, spreading, and dispersing 

agents; propellants in aerosol 

dispensers; microencapsulating agents; 

and emulsifiers. The term ‘‘inert’’ is not 

intended to imply nontoxicity; the 

ingredient may or may not be 

chemically active. Generally, EPA has 

exempted inert ingredients from the 

requirement of a tolerance based on the 

low toxicity of the individual inert 

ingredients. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

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

allows EPA to establish an exemption 

from the requirement of a tolerance (the 


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51472 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 

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. . . .’’ 

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. 

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

of FFDCA, and the factors specified in 

section 408(b)(2)(D) of FFDCA, EPA has 

reviewed the available scientific data 

and other relevant information in 

support of this action. EPA has 

sufficient data to assess the hazards of 

and to make a determination on 

aggregate exposure for the petitioned-for 

exemption from the requirement of a 

tolerance for residues of the SANFCs 

when used as inert ingredients in 

pesticide formulations applied preharvest and post-harvest. EPA′s 

assessment of exposures and risks 

associated with establishing tolerances 

follows. 

A. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

The toxicology database for the 

SANFC inerts is adequate to support 

their use as inert ingredients in 

pesticide formulations. The existing 

toxicology database for the SANFC 

consists of two OPPTS Harmonized 

Guidelines 870.3650 (combined 

repeated dose toxicity study with the 

reproduction/developmental toxicity 

screening test in rats), and several 

studies from the scientific literature on 

acute toxicity and mutagenicity. 

The available toxicity data indicates 

that SANFC has low acute oral and 

inhalation toxicity. SANFC was not 

mutagenic in an Ames test. In a repeated 

28 to 42 day OPPTS Harmonized 

Guideline 870.3650 combined repeated 

dose toxicity study with the 

reproduction/developmental toxicity 

screening with the representative test 

compound, naphthalenesulfonic acid, 

sodium salt polymer with formaldehyde 

(CAS 9084–06–4), there was no 

evidence of increased susceptibility. 

Parental toxicity manifested as 

decrements in body-weight gain in both 

sexes at the limit dose (1,000 

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

No developmental or reproductive 

effects were observed at doses of 100, 

300, and 1,000 mg/kg/day. In an OPPTS 

Harmonized Guideline 870.3650 study 

submitted by Akzo Nobel Chemistry, 

LLC, no systemic toxicity was observed 

at doses up to and including 456 mg/kg/ 

day. The highest dose tested (HDT). 

There was no evidence of potential 

neurotoxicity or immunotoxicity in the 

adult animal in the OPPTS Harmonized 

Guideline 870.3650 study at the limit 

dose of 1,000 mg/kg/day. There is no 

evidence that the SANFCs are 

carcinogenic. There are no chronic data 

available on the SANFC surfactants; 

however, no structural alerts for cancer 

were identified in a qualitative structure 

activity relationship (SAR) database, 

DEREK Version 11. In addition, there 

was little concern about any of the 

postulated metabolites having greater 

toxicity than the parent compounds. 

The higher molecular weight (MW) 

polymeric SANFC surfactants (MW 

>1,000) are not expected to be readily 

absorbed or metabolized, and should 

thus be rapidly excreted (likely in the 

feces) unchanged. Additionally, lower 

molecular microsome cytochrome P-450 

oxygenases may hydroxylate the 

naphthalene ring and/or methylene 

bridge to produce alternative 

metabolites that should also be readily 

conjugated and excreted. Furthermore, 

these compounds are formaldehyde 

condensates and do not contain free 

formaldehyde. Therefore, formaldehyde 

is not a residue of concern. In summary, 

all available data indicate that SANFCs 

have a low hazard potential. 

Specific information on the studies 

received are included in the Agency′s 

Human Health Risk Assessment which 

can be found at http:// 

www.regulations.gov in document 

Sodium and Ammonium 

Naphthalenesulfonate Formaldehyde 

Condensates (SANFCs) - JITF CST 11 

Inert Ingredients), Human Health Risk 

Assessment to Support Proposed 

Exemption from the Requirement of a 

Tolerance When Used as Inert 

Ingredients in Pesticide Formulations, 

pages 6–8 and 11–14 in docket ID 

number EPA–HQ–OPP–2009–0043 and 

also in document Mono-, Di-, and 

Trimethylnapthalensulfonic Acids and 

Naphthalenesulfonic Acids 

Formaldehyde Condensates, 

Ammonium and Sodium Salts: Review 

of Toxicological Studies in Support of 

an Exemption from the Requirement of 

a Tolerance (40 CFR 180.920 and 40 

CFR 180.910) When Used as Inert 

Ingredients in Pesticide Formulations in 

docket ID number EPA–HQ–OPP–2008– 

0822. 

B. Toxicity Endpoint Selection and 

FQPA Considerations 

There was no significant hazard 

identified in the OPPTS Harmonized 

Guideline 870.3650 study at the limit 

dose of 1,000 mg/kg/day to either 

parental animals or their offspring. 

Thus, due to their low potential hazard 

and the lack of a hazard endpoint, it was 

determined that a quantitative risk 

assessment using safety factors applied 

to a point of departure protective of an 

identified hazard endpoint is not 

appropriate for the SANFCs. The 

Agency notes that there was no 

evidence of neurotoxicity or increased 

susceptibility to the offspring of rats 

following prenatal or postnatal exposure 

in the OPPTS Harmonized Guideline 

870.3650 studies. Based on this 

information, there is no concern, at this 

time, for increased sensitivity to infants 

and children to the SANFCs when used 

as inert ingredients in pesticide 

formulations applied pre-harvest and 

post-harvest and a safety factor analysis 

has not been used to assess risk. For the 

same reason, EPA has determined that 

an additional safety factor is not needed 

to protect the safety of infants and 

children. 

C. 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). 

The SANFC inerts are used as 

disperants, defoamers and emulsifiers in 

pesticide formulations. These 

surfactants have a wide range of 


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Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 51473 

industrial uses as well as serving as 

emulsifiers in personal care products 

and in food contact packaging. 

The residues of concern are the parent 

compound only. Considering the large 

size and polarity of the SANFC 

molecules, it is unlikely that they would 

be readily absorbed by livestock or 

taken up by plants for further 

metabolism. 

No hazard was identified for the acute 

and chronic dietary assessment (food 

and drinking water), or for the shortterm, intermediate-term, and long-term 

residential assessments, and therefore, 

no quantitative aggregate exposure 

assessments were performed. 

D. 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 the SANFCs to 

share a common mechanism of toxicity 

with any other substances, and SANFCs 

do not appear to produce a toxic 

metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that SANFCs do not have a 

common mechanism of toxicity with 

other substances. For information 

regarding EPA′s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

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

www.epa.gov/pesticides/cumulative. 

E. Determination of safety 

Based on all available information, 

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 

residues of the SANFCs when used as 

inert ingredients in pesticide 

formulations applied pre-harvest and 

post-harvest. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

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. Existing Exemptions 

The SANFCs have an existing 

exemption from the requirement of a 

tolerance under 40 CFR 180.920 for use 

as inert ingredients in pesticide 

formulations applied to growing crops. 

C. International Residue Limits 

The Agency is not aware of any 

country requiring a tolerance for the 

SANFCs nor have any CODEX 

Maximum Residue Levels been 

established for any food crops at this 

time. 

VI. Conclusion 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of the SANFCs, under the 

tolerance expression mono-, di-, and 

trimethylnapthalenesulfonic acids and 

napthalenesulfonic acids formaldehyde 

condensates, ammonium and sodium 

salts, when used as inert ingredients in 

pesticide formulations applied preharvest and post-harvest. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes tolerances 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the exemption 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: September 30, 2009. 

G. Jeffrey Herndon, 

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. 


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51474 Federal Register / Vol. 74, No. 193 / Wednesday, October 7, 2009 / Rules and Regulations 

■ 2. In §180.910, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.910 Inert ingredients used pre- and 

post-harvest; exemptions from the 

requirement of a tolerance. 

* * * * * 

Inert Ingredients Limits Uses 

* * * * ***

Mono-, di-, and trimethylnapthalenesulfonic acids and napthalenesulfonic 

acids formaldehyde condensates, ammonium and sodium salts (CAS Reg. 

Nos 9008–63–3, 9069–80–1, 9084–06–4, 36290–04–7, 91078–68–1, 

141959–43–5, 68425–94–5) 

Surfactants, related adjuvants of surfactants 

* * * *** *

[FR Doc. E9–24160 Filed 10–6–09; 8:45 am] 

BILLING CODE 6560–50–S 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0690; FRL–8437–3] 

C10-C18-Alkyl dimethyl amine oxides; 

Exemption from the Requirement of a 

Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of C10-C18-Alkyl 

dimethyl amine oxides (ADAO) when 

used as the inert ingredient in pesticide 

formulations applied to raw agricultural 

commodities pre- and post-harvest. 

Exponent on behalf of Stepan Company 

and Rhodia submitted petitions to EPA 

under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 

ADAOs. 

DATES: This regulation is effective 

October 7, 2009. Objections and 

requests for hearings must be received 

on or before December 7, 2009, 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–2009–0690. All documents in the 

dockets 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: Lisa 

Austin, Registration Division (7505P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 305–7894; e-mail address: 

austin.lisa@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 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 40 CFR part 180 

through the Government Printing 

Office’s e-CFR cite at http:// 

www.gpoaccess.gov/ecfr. To access the 

OPPTS Harmonized Guidelines 

referenced in this document, go to the 

guidelines at http://www.epa.gov/ 

opptsfrs/home/guidelin.htm. 

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. 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–2009–0690 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 December 7, 2009. 

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 


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