[Federal Register Volume 75, Number 226 (Wednesday, November 24, 2010)]
[Rules and Regulations]
[Pages 71556-71559]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29625]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0061; FRL-8852-2]


Polyoxyalkylated Glycerol Fatty Acid Esters; Tolerance Exemption

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 polyoxyalkylated glycerol fatty acid 
esters; the mono-, di-, or triglyceride mixtures of C8 
through C22, primarily C8 through C18 
saturated and unsaturated, fatty acids containing up to 15% water by 
weight reacted with a minimum of three moles of either ethylene oxide 
or propylene oxide, also known as polyoxyalkylated glycerol fatty acid 
esters, when used as an inert ingredient in a pesticide chemical 
formulation under 40 CFR 180.960. Croda Inc., 315 Cherry Lane, 
Wilmington, DE submitted a petition 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 polyoxyalkylated 
glycerol fatty acid esters; the mono-, di-, or triglyceride mixtures of 
C8 through C22, primarily C8 through 
C18 saturated and unsaturated, fatty acids containing up to 
15% water by weight reacted with a minimum of three moles of either 
ethylene oxide or propylene oxide, also known as polyoxyalkylated 
glycerol fatty acid esters, when used as an inert ingredient in a 
pesticide chemical formulation on food or feed commodities.

DATES: This regulation is effective November 24, 2010. Objections and 
requests for hearings must be received on or before January 24, 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-2009-0661. 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: [email protected].

SUPPLEMENTARY INFORMATION:

[[Page 71557]]

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. 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-2009-0661 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 
January 24, 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-2009-0661, by one of the following methods.
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of June 8, 2010 (75 FR 32463) (FRL-8827-5), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
announcing the receipt of a pesticide petition (PP 9E7538) filed by 
Croda Inc., 315 Cherry Lane, Wilmington, DE. The petition requested 
that 40 CFR 180.960 be amended by establishing an exemption from the 
requirement of a tolerance for residues of polyoxyalkylated glycerol 
fatty acid esters; the mono-, di-, or triglyceride mixtures of 
C8 through C22, primarily C8 through 
C18 saturated and unsaturated, fatty acids containing up to 
15% water by weight reacted with a minimum of three moles of either 
ethylene oxide or propylene oxide (CAS Reg. Nos. 61791-23-9, 68201-46-
7, 68440-49-3, 68458-88-8, 68606-12-2, 68648-38-4, 70377-91-2, 70914-
02-2, 72245-12-6, 72698-41-3, 180254-52-8, 248273-72-5, 308063-50-5, 
952722-33-7). That notice included a summary of the petition prepared 
by the petitioner and solicited comments on the petitioner's request. 
The Agency did not receive any comments.
    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 exemption is ``safe.'' Section 408(c)(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 use 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 an exemption from the 
requirement of 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 * * *'' and 
specifies factors EPA is to consider in establishing an exemption.

III. Risk Assessment and Statutory Findings

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be shown 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 FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability 
and the relationship of this information to human risk. EPA has also 
considered available information concerning the variability of the 
sensitivities of major identifiable subgroups of consumers, including 
infants and children. In the case of certain chemical substances that 
are defined as polymers, the Agency has established a set of criteria 
to identify categories of polymers expected to present minimal or no 
risk. 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). Short chemical name conforms to the 
definition of a polymer given in 40 CFR 723.250(b) and meets the 
following criteria that are used to identify low-risk polymers.

[[Page 71558]]

    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, the polymer also meets as required the following 
exemption criteria specified in 40 CFR 723.250(e).
    7. The polymer's number average MW of 1,500 is greater than 1,000 
and less than 10,000 daltons. The polymer contains less than 10% 
oligomeric material below MW 500 and less than 25% oligomeric material 
below MW1,000, and the polymer does not contain any reactive functional 
groups.
    Thus, polyoxyalkylated glycerol fatty acid esters meet the criteria 
for a polymer to be considered low risk under 40 CFR 723.250. Based on 
its conformance to the criteria in this unit, no mammalian toxicity is 
anticipated from dietary, inhalation, or dermal exposure to 
polyoxyalkylated glycerol fatty acid esters.

IV. Aggregate Exposures

    For the purposes of assessing potential exposure under this 
exemption, EPA considered that short chemical name could be present in 
all raw and processed agricultural commodities and drinking water, and 
that non-occupational non-dietary exposure was possible. The number 
average MW of polyoxyalkylated glycerol fatty acid esters is 1,500 
daltons. Generally, a polymer of this size would be poorly absorbed 
through the intact gastrointestinal tract or through intact human skin. 
Since polyoxyalkylated glycerol fatty acid esters conform to the 
criteria that identify a low-risk polymer, there are no concerns for 
risks associated with any potential exposure scenarios that are 
reasonably foreseeable. The Agency has determined that a tolerance is 
not necessary to protect the public health.

V. 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 
considers ``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 polyoxyalkylated glycerol fatty acid esters to 
share a common mechanism of toxicity with any other substances, and 
short chemical name does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that polyoxyalkylated glycerol fatty 
acid esters 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.

VI. Additional Safety Factor for the Protection of Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold margin of safety for infants and children in the 
case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the data base unless EPA concludes 
that a different margin of safety will be safe for infants and 
children. Due to the expected low toxicity of polyoxyalkylated glycerol 
fatty acid esters, EPA has not used a safety factor analysis to assess 
the risk. For the same reasons the additional tenfold safety factor is 
unnecessary.

VII. Determination of Safety

    Based on the conformance to the criteria used to identify a low-
risk polymer, EPA concludes that there is a reasonable certainty of no 
harm to the U.S. population, including infants and children, from 
aggregate exposure to residues of polyoxyalkylated glycerol fatty acid 
esters.

VIII. Other Considerations

A. Existing Exemptions From a Tolerance

    There are no existing exemptions from the requirement of a 
tolerance for polyoxyalkylated glycerol fatty acid esters.

B. 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.

C. 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 polyoxyalkylated glycerol 
fatty acid esters.

IX. Conclusion

    Accordingly, EPA finds that exempting residues of polyoxyalkylated 
glycerol fatty acid esters from the requirement of a tolerance will be 
safe.

X. 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 rules 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 involve any technical standards that 
would require Agency consideration of voluntary consensus standards 
pursuant to section 12(d) of

[[Page 71559]]

the National Technology Transfer and Advancement Act of 1995 (NTTAA), 
Public Law 104-113, section 12(d) (15 U.S.C. 272 note).
    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, or otherwise have any unique 
impacts on local governments. 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).
    Although this action does not 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), EPA seeks to achieve 
environmental justice, the fair treatment and meaningful involvement of 
any group, including minority and/or low-income populations, in the 
development, implementation, and enforcement of environmental laws, 
regulations, and policies. As such, to the extent that information is 
publicly available or was submitted in comments to EPA, the Agency 
considered whether groups or segments of the population, as a result of 
their location, cultural practices, or other factors, may have atypical 
or disproportionately high and adverse human health impacts or 
environmental effects from exposure to the pesticide discussed in this 
document, compared to the general population.

XI. 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 rule in the Federal 
Register. This 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: November 17, 2010.
G. Jeffery Herndon,
Acting Director, Registration Division, Office of Pesticide Programs.

0
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.  180.960, the table is amended by adding alphabetically the 
following polymers to read as follows:


Sec.  [emsp14]180.960  Polymers; exemptions from the requirement of a 
tolerance.

* * * * *

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                 Polymer                              CAS No.
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                               * * * * * *
Polyoxyalkylated glycerol fatty acid      61791-23-9, 68201-46-7, 68440-
 esters; the mono-, di-, or triglyceride   49-3, 68458-88-8, 68606-12-2,
 mixtures of C8 through C22, primarily     68648-38-4, 70377-91-2, 70914-
 C8 through C18 saturated and              02-2, 72245-12-6, 72698-41-3,
 unsaturated, fatty acids containing up    180254-52-8, 248273-72-5,
 to 15% water by weight reacted with a     308063-50-5, 952722-33-7.
 minimum of three moles of either
 ethylene oxide or propylene oxide; the
 resulting polyoxyalkylated glycerol
 ester polymer minimum number average
 molecular weight (in amu), 1,500.
 
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[FR Doc. 2010-29625 Filed 11-23-10; 8:45 am]
BILLING CODE 6560-50-P