Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 7703 

■ 2. Add a temporary § 100.T07–1151 to 

read as follows: 

§ 100.T07–1151 Special Local Regulations; 

Krewe of Charleston Mardi Gras Boat 

Parade, Charleston Harbor, Charleston, SC. 

(a) Regulated Area. The following 

buffer zones are regulated areas during 

the Krewe of Charleston Mardi Gras 

Boat Parade: All waters within 500 

yards in front of the lead parade vessel; 

all waters within 100 yards behind the 

last parade vessel; and all waters within 

50 yards on either side of all marine 

parade participant vessels. The identity 

of the lead parade vessel and the last 

parade vessel will be provided prior to 

the marine parade via broadcast notice 

to mariners and marine safety 

information bulletins. The parade will 

commence at the Charleston City 

Marina, transit the Ashley River, head 

north between Shutes Folly Island and 

the Charleston peninsula, and then turn 

around in Customhouse Reach. The 

parade will then return to the 

Charleston City Marina by the same 

route. 

(b) Definition. The term ‘‘designated 

representative’’ means Coast Guard 

Patrol Commanders, including Coast 

Guard coxswains, petty officers, and 

other officers operating Coast Guard 

vessels, and Federal, State, and local 

officers designated by or assisting the 

Captain of the Port Charleston in the 

enforcement of the regulated areas. 

(c) Regulations. 

(1) All persons and vessels are 

prohibited from entering, transiting 

through, anchoring in, or remaining 

within the regulated areas unless 

authorized by the Captain of the Port 

Charleston or a designated 

representative. 

(2) Persons and vessels desiring to 

enter, transit through, anchor in, or 

remain within the regulated areas may 

contact the Captain of the Port 

Charleston by telephone at 843–740– 

7050, or a designated representative via 

VHF radio on channel 16 to seek 

authorization. If authorization to enter, 

transit through, anchor in, or remain 

within the regulated areas is granted by 

the Captain of the Port Charleston or a 

designated representative, all persons 

and vessels receiving such permission 

must comply with the instructions of 

the Captain of the Port Charleston or a 

designated representative. 

(3) The Coast Guard will provide 

notice of the marine parade and 

regulated areas through advanced notice 

via broadcast notice to mariners and by 

on-scene designated representatives. 

(d) Effective Date. This rule is 

effective from 10 a.m. until 2 p.m. on 

February 12, 2011. 

Dated: January 29, 2011. 

William D. Baumgartner, 

Rear Admiral, U.S. Coast Guard, Commander, 

Seventh Coast Guard District. 

[FR Doc. 2011–2948 Filed 2–10–11; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0838; FRL–8863–9] 

1,4-Benzenedicarboxylic Acid, 

Dimethyl Ester, Polymer With 1,4- 

Butanediol, Adipic Acid, and 

Hexamethylene Diisocyanate; 

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 1,4-benzenedi

carboxylic acid, dimethyl ester, polymer 

with 1,4-butanediol, adipic acid, and 

hexamethylene diisocyanate (CAS Reg. 

No. 55231–08–8), minimum number 

average molecular weight (in amu) 

30,000, when used as an inert ingredient 

(component of controlled release agent) 

in honeybee hive miticide formulations 

under regulations for inert ingredients 

used pre-harvest (growing crops only). 

NOP Apiary Products USA, Inc., 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA), requesting establishment of an 

exemption from the requirement of a 

tolerance. This regulation eliminates the 

need to establish a maximum 

permissible level for residues of 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate. 

DATES: This regulation is effective 

February 11, 2011. Objections and 

requests for hearings must be received 

on or before April 12, 2011, 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–2010–0838. 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: 

Kerry Leifer, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8811; e-mail address: leifer.

kerry@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. 


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7704 Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 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–2010–0838 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 12, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 

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. Information not marked 

confidential pursuant to 40 CFR part 2 

may be disclosed publicly by EPA 

without prior notice. Submit a copy of 

your non-CBI objection or hearing 

request, identified by docket ID number 

EPA–HQ–OPP–2010–0838, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Petition for Exemption 

In the Federal Register of October 22, 

2010 (75 FR 65321) (FRL–8851–1), EPA 

issued a notice pursuant to section 408 

of FFDCA, 21 U.S.C. 346a, announcing 

the filing of a pesticide petition (PP 

0E7780) by NOD Apiary Products USA 

Inc., 8345 NW. 66th Street #8418, 

Miami, FL 33166. The petition 

requested that 40 CFR 180.920 be 

amended by establishing an exemption 

from the requirement of a tolerance for 

residues of 1,4-benzenedicarboxylic 

acid, dimethyl ester, polymer with 

1,4-butanediol, adipic acid, and 

hexamethylene diisocyanate (CAS Reg. 

No. 55231–08–8) when used as an inert 

ingredient (component of controlled 

release agent) in miticide formulations 

applied to honeybee hives. That notice 

referenced a summary of the petition 

prepared by NOD Apiary Products USA 

Inc., the petitioner, which is available in 

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

There were no comments received in 

response to the notice of filing. 

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(c)(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.’’ 

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 establishes exemptions from the 

requirement of a tolerance only in those 

cases where it can be clearly 

demonstrated that the risks from 

aggregate exposure to pesticide 

chemical residues under reasonably 

foreseeable circumstances will pose no 

appreciable risks to human health. In 

order to determine the risks from 

aggregate exposure to pesticide inert 

ingredients, the Agency considers the 

toxicity of the inert in conjunction with 

possible exposure to residues of the 

inert ingredient through food, drinking 

water, and through other exposures that 

occur as a result of pesticide use in 

residential settings. If EPA is able to 

determine that a finite tolerance is not 

necessary to ensure that there is a 

reasonable certainty that no harm will 

result from aggregate exposure to the 

inert ingredient, an exemption from the 

requirement of a tolerance may be 

established. 

Consistent with section 408(c)(2)(A) 

of FFDCA, and the factors specified in 

FFDCA section 408(c)(2)(B), 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 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate including exposure 

resulting from the exemption 

established by this action. EPA’s 

assessment of exposures and risks 

associated with 1,4-benzenedicarboxylic 

acid, dimethyl ester, polymer with 

1,4-butanediol, adipic acid, and 

hexamethylene diisocyanate follows. 

A. Toxicological Profile 

1,4-Benzenedicarboxylic acid, 

dimethyl ester, polymer with 

1,4-butanediol, adipic acid, and 

hexamethylene diisocyanate is a 

polyester-type polymer. The Agency has 

established a set of criteria to identify 

categories of polymers expected to 

present minimal or no risk to human 

health or the environment. The 

definition of a polymer is given in 40 

CFR 723.250(b) and the exclusion 

criteria for identifying these low-risk 

polymers are described in 40 CFR 

723.250(d). 1,4-Benzenedicarboxylic 

acid, dimethyl ester, polymer with 

1,4-butanediol, adipic acid, and 

hexamethylene diisocyanate conforms 

to the definition of a polymer given in 

40 CFR 723.250(b) and meets all of the 

following criteria, with the exception of 

the ‘‘polymers which degrade, 

decompose or depolymerize’’ criterion 

(specified in 40 CFR 723.250(e) below), 


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Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 7705 

that are used to identify low-risk 

polymers. 

1. The polymer is not a cationic 

polymer nor is it reasonably anticipated 

to become a cationic polymer in a 

natural aquatic environment. 

2. The polymer does contain as an 

integral part of its composition the 

atomic elements carbon, hydrogen, and 

oxygen. 

3. The polymer does not contain as an 

integral part of its composition, except 

as impurities, any element other than 

those listed in 40 CFR 723.250(d)(2)(ii). 

4. The polymer is neither designed 

nor can it be reasonably anticipated to 

substantially degrade, decompose, or 

depolymerize. 

5. The polymer is manufactured or 

imported from monomers and/or 

reactants that are already included on 

the TSCA Chemical Substance 

Inventory or manufactured under an 

applicable TSCA section 5 exemption. 

6. The polymer is not a water 

absorbing polymer with a number 

average molecular weight (MW) greater 

than or equal to 10,000 daltons. 

Additionally, in order to meet the low 

risk polymer criteria, the polymer also 

meets as required the exemption criteria 

specified in 40 CFR 723.250(e)(3) 

regarding polyester polymers made 

solely from specified reactants. 1,4- 

Benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate does undergo 

biodegradation in the environment and 

thus does not meet criterion number 4. 

listed in this unit; however, the Agency 

believes that this biodegradation in the 

environment is not a safety concern for 

humans because information provided 

by the petitioner as well as information 

contained in the environmental 

assessment that was part of the Food 

and Drug Administration Food Contact 

Notification (FDA FCN) indicates that 

the polymer would ultimately 

biodegrade into carbon dioxide and 

water and not be a concern to humans 

or the environment. This determination 

is further supported by biodegradation 

and ecotoxicity testing of a 

representative material in which the 

substance was determined to be readily 

biodegradable and nontoxic to 

earthworms. Due to its large size 

(minimum number average molecular 

weight 30,000 amu) and the general 

conformance to the criteria for 

identifying low risk polymers under 40 

CFR 723.250, 1,4-benzenedicarboxylic 

acid, dimethyl ester, polymer with 

1,4-butanediol, adipic acid, and 

hexamethylene diisocyanate would not 

be expected to be absorbed through the 

intact gastrointestinal tract nor be 

anticipated to penetrate intact human 

skin. Inhalation exposure is not 

expected due to the nonvolatility of 

(component of controlled release agent) 

in honeybee hive miticide formulations. 

Because of its inability to enter systemic 

circulation when used as an inert 

ingredient in pesticide formulations 

1,4-benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate is essentially nontoxic. 

1,4-Benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate has also been accepted by 

the FDA as being safe for use as a food 

contact substance to be used with all 

food types as a single-use film or coating 

under section 409(h)(2) of the FFDCA 

(Effective Food Contact Notification 

(FCN) No. 916). Based on the 

assessment in this unit, the Agency has 

concluded that a standard battery of 

toxicological studies are not necessary. 

B. Toxicological Points of Departure/ 

Levels of Concern 

Due to the low potential hazard and 

lack of an identified hazard endpoint for 

1,4-benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate, the Agency has 

determined that a quantitative risk 

assessment using safety factors applied 

to a point of departure protective of an 

identified hazard endpoint is not 

appropriate. 

C. Exposure Assessment 

1. Dietary exposure from food and 

feed uses and drinking water. In 

evaluating dietary exposure to 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate, EPA considered exposure 

under the proposed exemption from the 

requirement of a tolerance. The primary 

route of dietary exposure to 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate from its use as an inert 

ingredient in pesticide products would 

be through consumption of honey. Use 

of 1,4-benzenedicarboxylic acid, 

dimethyl ester, polymer with 1,4- 

butanediol, adipic acid, and 

hexamethylene diisocyanate in miticide 

products applied to treat honeybee 

hives may possibly also result in 

exposure through drinking water (from 

runoff). Dietary exposure to 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate may also result from its use 

as a food contact substance. Because no 

hazards associated with dietary 

exposure were identified for 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate, a quantitative dietary 

exposure assessment for 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate was not conducted. 

2. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., textiles (clothing and diapers), 

carpets, swimming pools, and hard 

surface disinfection on walls, floors, 

tables). Since there are no residential 

uses of pesticide products containing 

1,4-benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate as an inert ingredient, 

residential exposures are not expected 

and a residential exposure assessment 

was not conducted. 

3. 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 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate to share a common 

mechanism of toxicity with any other 

substances, and 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate does not appear to produce 

a toxic metabolite produced by other 

substances. For the purposes of this 

tolerance action, therefore, EPA has 

assumed that 1,4-benzenedicarboxylic 

acid, dimethyl ester, polymer with 

1,4-butanediol, adipic acid, and 

hexamethylene diisocyanate does not 

have a common mechanism of toxicity 

with other substances. For information 

regarding EPA’s efforts to determine 

which chemicals have a common 

mechanism of toxicity and to evaluate 

the cumulative effects of such 

chemicals, see EPA’s Web site at http:// 

www.epa.gov/pesticides/cumulative. 


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D. Safety Factor for Infants and 

Children 

Due to the large molecular weight of 

1,4-benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate it is unlikely that it will 

enter systemic circulation from either 

the gastrointestinal tract or intact 

human skin. As a result, it is unlikely 

to elicit a toxic response in infants and 

children when used as an inert 

ingredient in pesticide products; 

therefore EPA did not use a safety factor 

analysis for assessing risk. For similar 

reasons, the additional safety factor for 

the protection of infants and children is 

not necessary. 

E. Aggregate Risks and Determination of 

Safety 

As indicated in this unit, 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate would be incapable of 

entering systemic circulation and 

therefore, unable to elicit a toxic 

response in humans. Taking into 

consideration all available information 

on 1,4-benzenedicarboxylic acid, 

dimethyl ester, polymer with 1,4- 

butanediol, adipic acid, and 

hexamethylene diisocyanate, EPA has 

determined that there is a reasonable 

certainty that no harm to any population 

subgroup, including infants and 

children, will result from aggregate 

exposure to 1,4-benzenedicarboxylic 

acid, dimethyl ester, polymer with 1,4- 

butanediol, adipic acid, and 

hexamethylene diisocyanate under 

reasonable foreseeable circumstances. 

Therefore, the establishment of an 

exemption from tolerance under 40 CFR 

180.920 for residues of 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate, minimum number average 

molecular weight (in amu) 30,000 when 

used as an inert ingredient (component 

of controlled release agent) in honeybee 

hive miticide formulations is safe under 

FFDCA section 408. 

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. International Residue Limits 

In making its tolerance decisions, EPA 

seeks to harmonize U.S. tolerances with 

international standards whenever 

possible, consistent with U.S. food 

safety standards and agricultural 

practices. EPA considers the 

international maximum residue limits 

(MRLs) established by the Codex 

Alimentarius Commission (Codex), as 

required by FFDCA section 408(b)(4). 

The Codex Alimentarius is a joint U.N. 

Food and Agriculture Organization/ 

World Health Organization food 

standards program, and it is recognized 

as an international food safety 

standards-setting organization in trade 

agreements to which the United States 

is a party. EPA may establish a tolerance 

that is different from a Codex MRL; 

however, FFDCA section 408(b)(4) 

requires that EPA explain the reasons 

for departing from the Codex level. 

The Codex has not established a MRL 

for 1,4-benzenedicarboxylic acid, 

dimethyl ester, polymer with 1,4- 

butanediol, adipic acid, and 

hexamethylene diisocyanate. 

VI. Conclusions 

Therefore, an exemption from the 

requirement of a tolerance is established 

under 40 CFR 180.920 for 1,4- 

benzenedicarboxylic acid, dimethyl 

ester, polymer with 1,4-butanediol, 

adipic acid, and hexamethylene 

diisocyanate (CAS Reg. No. 55231–08– 

8), minimum number average molecular 

weight (in amu) 30,000, when used as 

an inert ingredient (component of 

controlled release agent) in honeybee 

hive miticide formulations. 

VII. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under section 408(d) of FFDCA in 

response to a petition submitted to the 

Agency. The Office of Management and 

Budget (OMB) has exempted these types 

of actions from review under Executive 

Order 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993). Because this final rule 

has been exempted from review under 

Executive Order 12866, this final rule is 

not subject to Executive Order 13211, 

entitled Actions Concerning Regulations 

That Significantly Affect Energy Supply, 

Distribution, or Use (66 FR 28355, May 

22, 2001) or Executive Order 13045, 

entitled Protection of Children from 

Environmental Health Risks and Safety 

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

This final rule does not contain any 

information collections subject to OMB 

approval under the Paperwork 

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

seq., nor does it require any special 

considerations under Executive Order 

12898, entitled Federal Actions to 

Address Environmental Justice in 

Minority Populations and Low-Income 

Populations (59 FR 7629, February 16, 

1994). 

Since tolerances and exemptions that 

are established on the basis of a petition 

under section 408(d) of FFDCA, such as 

the tolerance in this final rule, do not 

require the issuance of a proposed rule, 

the requirements of the Regulatory 

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

seq.) do not apply. 

This final rule directly regulates 

growers, food processors, food handlers, 

and food retailers, not States or Tribes, 

nor does this action alter the 

relationships or distribution of power 

and responsibilities established by 

Congress in the preemption provisions 

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

the Agency has determined that this 

action will not have a substantial direct 

effect on States or Tribal governments, 

on the relationship between the national 

government and the States or Tribal 

governments, or on the distribution of 

power and responsibilities among the 

various levels of government or between 

the Federal Government and Indian 

Tribes. Thus, the Agency has 

determined that Executive Order 13132, 

entitled Federalism (64 FR 43255, 

August 10, 1999) and Executive Order 

13175, entitled Consultation and 

Coordination with Indian Tribal 

Governments (65 FR 67249, November 

9, 2000) do not apply to this final rule. 

In addition, this final rule does not 

impose any enforceable duty or contain 

any unfunded mandate as described 

under Title II of the Unfunded Mandates 

Reform Act of 1995 (UMRA) (Pub. L. 

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). 


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Federal Register / Vol. 76, No. 29 / Friday, February 11, 2011 / Rules and Regulations 7707 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: February 4, 2011. 

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. In § 180.920, the table is amended 

by adding alphabetically the following 

inert ingredients to read as follows: 

§ 180.920 Inert ingredients used preharvest; exemptions from the requirement 

of a tolerance. 

* * * * * 

Inert ingredients Limits Uses 

*******

1,4-Benzenedicarboxylic acid, dimethyl ester, polymer with 

1,4-butanediol, adipic acid, and hexamethylene 

diisocyanate, minimum number average molecular weight 

(in amu) 30,000 (CAS Reg. No. 55231–08–8).

For use in honeybee hive miticide formulations.Component of controlled release agent. 

* * * * * * * 

[FR Doc. 2011–3111 Filed 2–10–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0982; FRL–8859–6] 

Fludioxonil; Pesticide Tolerances for 

Emergency Exemptions 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

time-limited tolerance for residues of 

fludioxonil in or on pineapple. 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 pesticide on 

pineapple. This regulation establishes a 

maximum permissible level for residues 

of fludioxonil in or on this commodity. 

The time-limited tolerance expires on 

December 31, 2013. 

DATES: This regulation is effective 

February 11, 2011. Objections and 

requests for hearings must be received 

on or before April 12, 2011, and must 

be filed in accordance with the 

instructions provided in 40 CFR part 

178 (see also Unit I.C. of the 

SUPPLEMENTARY INFORMATION section). 

ADDRESSES: EPA has established a 

docket for this action under docket 

identification (ID) number EPA–HQ– 

OPP–2010–0982. 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: 

Andrea Conrath, Registration Division 

(7505P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–9356; e-mail address: 

conrath.andrea@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. 

C. How 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. 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–2010–0982 in the subject line on 

the first page of your submission. All 

objections and requests for a hearing 

must be in writing, and must be 

received by the Hearing Clerk on or 

before April 12, 2011. Addresses for 

mail and hand delivery of objections 

and hearing requests are provided in 40 

CFR 178.25(b). 


emcdonald on DSK2BSOYB1PROD with RULES