[Federal Register Volume 74, Number 129 (Wednesday, July 8, 2009)]
[Rules and Regulations]
[Pages 32456-32460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-15927]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0888; FRL-8423-1]


Polyglyceryl Phthalate Ester of Coconut Oil Fatty Acids; 
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 polyglyceryl phthalate ester of coconut 
oil fatty acids (PPECFA) when used as inert ingredients in pesticide 
formulations applied to growing crops and raw agricultural commodities 
after harvest. The Joint Inerts Task Force (JITF), Cluster Support Team 
Number 23 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 PPECFA.

DATES: This regulation is effective July 8, 2009. Objections and 
requests for hearings must be received on or before September 8, 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-2008-0888. 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

[[Page 32457]]

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:

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.gpo/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-2008-0888 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 September 8, 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-2009-0045, 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 March 25, 2009 (74 FR 12856) (FRL-8399-
4), 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 
8E7465) by the JITF, Cluster Support Team Number 23 (CST 23), 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 an exemption from the requirement of a tolerance for 
residues of the inert ingredient PPECFA (this substance is also 
referred to throughout this document as PPECFA). That notice referenced 
a summary of the petition prepared by the JITF, CST 23, the petitioner, 
which is available to the public in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    This petition was submitted in response to a final rule of August 
9, 2006, (71 FR 45415) in which the Agency revoked, under section 
408(e)(1) of the FFDCA, the existing exemptions from the requirement of 
a tolerance for residues of certain inert ingredients because of 
insufficient data to make the determination of safety required by FFDCA 
section 408(b)(2). The expiration date for the tolerance exemptions 
subject to revocation was August 9, 2008, which was later extended to 
August 9, 2009 (73 FR 45312 ) to allow for data to be submitted to 
support the establishment of tolerance exemptions for these inert 
ingredients prior to the effective date of the tolerance exemption 
revocation.

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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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 PPECFA 
when used as inert ingredients in pesticide formulations applied to 
growing crops or food-producing animals. 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.
    PPECFA is not acutely toxic by the oral or dermal routes of 
exposure and is slightly irritating to the eyes, and non-irritating to 
the skin. It is not a skin sensitizer. There was no hazard identified 
in a combined repeat dose rat reproductive/developmental screening 
study at the limit dose of 1,000 milligrams/kilogram/day (mg/kg/day) to 
either parental animals or their offspring. There is no concern for 
neurotoxicity, immunotoxicity or carcinogenicity for PPECFA.
    Specific information on the studies received and the nature of any 
observed effects caused by PPECFA as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document ``PPECFA; JITF CST 23 Inert 
Ingredients)''. Human Health Risk Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations, pp 5-7 in docket ID number EPA-
HQ-OPP-2008-0888.

B. Toxicological Endpoints

    For hazards that have a threshold below which there is no 
appreciable risk, a toxicological point of departure (POD) is 
identified as the basis for derivation of reference values for risk 
assessment. The POD may be defined as the highest dose at which no 
adverse effects are observed (the NOAEL) in the toxicology study 
identified as appropriate for use in risk assessment. However, if a 
NOAEL cannot be determined, the lowest dose at which adverse effects of 
concern are identified (the LOAEL) or a Benchmark Dose (BMD) approach 
is sometimes used for risk assessment. Uncertainty/safety factors (UFs) 
are used in conjunction with the POD to take into account uncertainties 
inherent in the extrapolation from laboratory animal data to humans and 
in the variations in sensitivity among members of the human population 
as well as other unknowns. Safety is assessed for acute and chronic 
dietary risks by comparing aggregate food and water exposure to the 
pesticide to the acute population adjusted dose (aPAD) and chronic 
population adjusted dose (cPAD). The aPAD and cPAD are calculated by 
dividing the POD by all applicable UFs. Aggregate short-term, 
intermediate-term, and chronic-term risks are evaluated by comparing 
food, water, and residential exposure to the POD to ensure that the 
margin of exposure (MOE) called for by the product of all applicable 
UFs is not exceeded. This latter value is referred to as the Level of 
Concern (LOC).
    For non-threshold risks, the Agency assumes that any amount of 
exposure will lead to some degree of risk. Thus, the Agency estimates 
risk in terms of the probability of an occurrence of the adverse effect 
greater than that expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    There was no hazard identified in a combined repeated dose toxicity 
study with the reproduction/developmental toxicity screening test in 
rats with PPECFA 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, the Agency has determined 
that a quantitative risk assessment using safety factors applied to a 
POD protective of an identified hazard endpoint is not appropriate.
    The Agency used a qualitative structure activity relationship (SAR) 
database, DEREK11, to determine if there were structural alerts for 
potential carcinogenicity of PPECFA. No structural alerts for 
carcinogenicity were identified. PPECFA is not expected to be 
carcinogenic.

C. Exposure Assessment

    1. Dietary exposure (from food and feed uses and drinking water). 
Since an endpoint for risk assessment was not identified, a 
quantitative exposure assessment for PPECFA was not conducted. Any 
possible dietary exposure to PPECFA from its use as an inert ingredient 
in pesticide products would be through consumption of food to which 
pesticide products containing it have been applied and through drinking 
water (from runoff).
    2. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets).There are no 
residential uses for PPECFA.
    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 PPECFA to share a common mechanism of toxicity 
with any other substances, and PPECFA does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that PPECFA does not have 
a common mechanism of toxicity with other substances. For information 
regarding

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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.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA safety 
factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    The toxicity database for PPECFA is adequate for FQPA assessment 
and the potential exposure is adequately characterized given the low 
toxicity of the chemical. There was no hazard identified in a combined 
repeat dose rat reproductive/developmental screening study at the limit 
dose of 1,000 mg/kg/day to either parental animals or their offspring. 
There is no concern for neurotoxicity, immunotoxicity or 
carcinogenicity for PPECFA.
    Based on this information, there is no concern, at this time, for 
increased sensitivity to infants and children to PPECFA when used as an 
inert ingredient in pesticide formulations applied to growing crops or 
to raw agricultural commodities after 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.

E. Aggregate Risks and Determination of Safety

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be 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 ingredient 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.
    No data were submitted for PPECFA with respect to plant and animal 
metabolism or environmental degradation. Although the available 
toxicity data for PPECFA did not show any toxicity at up to 1,000 mg/
kg/day (the limit dose), which addresses the issue of potentially toxic 
in vivo metabolites, the Agency also considered degradation of PPECFA 
in the environment particularly the potential for PPECFA to degrade to 
alkyl phthalate esters. Alkyl phthalate esters such as bis(2-
ethylhexyl) phthalate (DEHP) have been shown to have concerns for 
teratogenicity, carcinogenicity, liver toxicity, and male reproductive 
toxicity. Based on physical and chemical characteristics and likely 
degradation processes, PPECFA is expected to degrade in the environment 
to phthalic acids, substances which do not exhibit the same toxicity as 
alkyl phthalate esters and are not of toxicological concern.
    Since an endpoint for risk assessment was not identified, a 
quantitative dietary risk assessment for PPECFA was not conducted. 
Given the lack of concern for hazard posed by PPECFA, EPA concludes 
that there are no dietary risks of concern as a result of exposure to 
PPECFA in food and water. Additionally, since there are no residential 
uses for PPECFA, a residential risk assessment was not performed. The 
Agency has not identified any concerns for carcinogenicity relating to 
PPECFA.
    Based on these risk assessments, 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 
PPECFA.

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

     The Agency is not aware of any country requiring a tolerance for 
PPPECFA 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 PPECFA when used as an inert ingredient in 
pesticide formulations applied to growing crops or to animals.

VII. Statutory and Executive Order Reviews

    This final rule establishes exemptions 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

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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: June 25, 2009.

Lois Rossi,

Director, Registration Division, Office of Pestiicide 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. 180.910, the table is amended by adding alphabetically the 
following inert ingredients to read as follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

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        Inert Ingredients               Limits               Uses
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                              * * * * * * *
Polyglyceryl phthalate ester of                       Surfactants,
 coconut oil fatty acids (CAS                          related adjuvants
 Reg. Nos. 67746-6070-9                                of surfactants
                              * * * * * * *
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[FR Doc. E9-15927 Filed 7-7-09; 8:45 am]
BILLING CODE 6560-50-S