Document ID: EPA-HQ-OPP-2010-0838-0003
Agency: epa
Document Type: Rule
Title: Exemptions from the Requirement of a Tolerance: 1,4-Benzenedicarboxylic Acid, Dimethyl Ester, Polymer with 1,4-Butanediol, Adipic Acid, and Hexamethylene Diisocyanate
Posted Date: 2011-02-11T05:00Z

[Federal Register Volume 76, Number 29 (Friday, February 11, 2011)]
[Rules and Regulations]
[Pages 7703-7707]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-3111]

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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.

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SUMMARY: This regulation establishes 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), 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.

[[Page 7704]]

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),

[[Page 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 non-occupational, 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.

[[Page 7706]]

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).

[[Page 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]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.920, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
             Inert ingredients                             Limits                             Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
1,4-Benzenedicarboxylic acid, dimethyl       For use in honeybee hive miticide  Component of controlled release
 ester, polymer with 1,4-butanediol, adipic   formulations.                      agent.
 acid, and hexamethylene diisocyanate,
 minimum number average molecular weight
 (in amu) 30,000 (CAS Reg. No. 55231-08-8).
 
                                                  * * * * * * *
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[FR Doc. 2011-3111 Filed 2-10-11; 8:45 am]
BILLING CODE 6560-50-P