[Federal Register Volume 74, Number 56 (Wednesday, March 25, 2009)]
[Rules and Regulations]
[Pages 12617-12621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-6263]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0346; FRL-8404-1]


Triethanolamine; 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 triethanolamine (CAS Reg. No. 102-71-6) 
when used as an inert ingredient in pesticide formulations applied to 
growing crops under 40 CFR 180.920. Bayer CropScience, LP submitted a 
petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), 
requesting an expansion of the existing Sec.  180.920 exemption from 
the requirement of a tolerance. This regulation eliminates the need to 
establish a maximum permissible level for residues of triethanolamine.

DATES: This regulation is effective March 25, 2009. Objections and 
requests for hearings must be received on or before May 26, 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-2008-0346. 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: Keri Grinstead, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 308-8373; e-mail address: <a href="/cdn-cgi/l/email-protection#402732292e33342521246e2b253229002530216e272f36"><span class="__cf_email__" data-cfemail="8ee9fce7e0fdfaebefeaa0e5ebfce7ceebfeefa0e9e1f8">[email protected]</span></a>.

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:
    <bullet> Crop production (NAICS code 111).
    <bullet> Animal production (NAICS code 112).
    <bullet> Food manufacturing (NAICS code 311).
    <bullet> Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file 
an objection to any aspect of this regulation and may also request a 
hearing on those objections. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. You must file your objection or request a hearing on 
this regulation in accordance with the instructions provided in 40 CFR 
part 178. To ensure proper receipt by EPA, you must identify docket ID 
number EPA-HQ-OPP-2008-0346 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before May 26, 2009.
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing that does not contain any CBI for inclusion in the public 
docket that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0346, by one of the following methods:
    <bullet> Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
    <bullet> Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
    <bullet> Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One

[[Page 12618]]

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 4, 2008 (73 FR 31862) (FRL-8365-3), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by FQPA (Public Law 104-170), announcing the filing of a 
pesticide petition (PP 8E7332) by Bayer CropScience LP, P.O. Box 12014, 
2 T.W. Alexander Dr., Research Triangle Park, NC 27709. The petition 
requested that the exemption in 40 CFR 180.920 for triethanolamine be 
amended by removing the restriction that triethanolamine could only be 
used in formulations applied before the crop emerged from the soil. 
That notice included a summary of the petition prepared by the 
petitioner. There were no comments received in response to the notice 
of filing.
    Section 408(b)(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 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.

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 ploymers 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. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, 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. The nature of the toxic effects caused by 
triethanolamine are discussed in this unit.
    Triethanolamine has an existing exemption from tolerance under 40 
CFR 180.920 when used as an inert ingredient in pesticide formulations 
applied before the crop emerges from the soil. This exemption was 
reassessed by EPA in 2006 and the reassessment document can be found at 
http://www.epa.gov/opprd001/inerts/decisiondoc_a2k.html. For ease of 
reading, triethanolamine is referred to as TEA. Summaries of the 
assessment for TEA are presented in this final rule. For more detailed 
information, refer to the docket for the more comprehensive assessment/
decision document.
    In animal studies, TEA has low acute toxicity via the oral and 
dermal routes, was nonirritating in eye and skin irritation studies, 
and did not induce skin sensitization. In repeat-dose testing, the main 
effect was on the liver and kidney with adverse effects seen at oral 
doses > 170 milligrams/kilogram/day (mg/kg/day). TEA is unlikely to be 
carcinogenic and studies indicate it is not mutagenic or 
developmentally toxic. Reproductive parameters were not affected in 
rats and mice treated dermally with TEA. When ingested, TEA appears to 
be rapidly absorbed in the gastrointestinal tract. In rodent studies, 
TEA was eliminated largely unchanged in the urine and feces within 2 
days.

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA directs EPA 
to consider available information concerning exposures from the 
pesticide residue in food and all other non-occupational exposures, 
including drinking water from ground water or surface water and 
exposure through pesticide use in gardens, lawns, or buildings 
(residential and other indoor uses).
    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.
     The primary route of exposure to TEA from its use as an inert 
ingredient in pesticide products applied to growing crops would most 
likely be through consumption of food to which pesticide products 
containing TEA have been applied, and possibly through drinking water 
(from runoff). Residential (dermal and inhalation) exposures are also 
possible from the use of home garden pesticide products containing TEA 
as an inert ingredient.
     There are no data provided regarding TEA residues in food or any 
other nonoccupational exposures to TEA. In the absence of actual 
residue data for TEA, the Agency performed a dietary (food and drinking 
water) exposure assessment for TEA when used as an inert ingredient in 
pesticide formulations applied to growing crops by using a series of 
very conservative assumptions. This exposure assessment was calculated 
based on the following

[[Page 12619]]

assumptions: (1) TEA would be used as an inert ingredient in all food 
use pesticide formulations applied to all crops, (2) 100% of all food 
crops would be treated with pesticide products containing TEA, (3) TEA 
residues would be present in all crops at levels equal to or exceeding 
the highest established tolerance levels for any pesticide active 
ingredient, and (4) TEA would be present in all sources of drinking 
water at concentrations equal to the highest established standards for 
drinking water contaminants established by EPA. This approach is highly 
conservative as it is extremely unlikely that TEA would have such use 
as a pesticide product inert ingredient and be present in food 
commodities and drinking water at such high levels. In addition, this 
highly conservative exposure assessment is protective of any possible 
non-occupational exposures to TEA, as it results in exposure estimates 
which are orders of magnitude greater than the high-end exposure 
estimates for residential uses of pesticides routinely used by EPA's 
Office of Pesticide Programs.

VI. Cumulative Effects

     Section 408(b)(2)(D)(v) of the 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.''
    Unlike other pesticides for which EPA has followed a cumulative 
risk approach based on a common mechanism of toxicity, EPA has not made 
a common mechanism of toxicity finding as to TEA and any other 
substances and, TEA does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has not assumed that TEA has 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 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative/.

VII. Safety Factor for the Protection of Infants and Children

    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. EPA has 
determined that reliable data show the safety of infants and children 
would be adequately protected if the FQPA SF were reduced to 1X. That 
decision is based on the following findings:
    1. The database is considered adequate for FQPA assessment based on 
available subchronic (rats), chronic/carcinogenicity (rats and mice), 
developmental (rats and mice), and reproduction (rats and mice) 
toxicity studies. No acute or subchronic neurotoxicity studies are 
available, but there were no clinical signs of neurotoxicity observed 
in the available database. Therefore, the Agency concluded that these 
studies are not required. In addition, the developmental neurotoxicity 
study is not required because there is no evidence of increased 
susceptibility to infants and children in the available developmental 
and reproduction studies in rats and mice and no clinical signs of 
neurotoxicity in the available studies. Based on the overall evidence, 
the Agency concluded that the database for triethanolamine is adequate 
for FQPA.
    2. Based on the developmental toxicity studies, EPA concludes that 
there is no evidence of increased susceptibility to infants and 
children. Developmental toxicity study in rats via the dermal route 
resulted in no biologically significant effects in the offspring or in 
the maternal animals. An oral Chernoff-Kavlock screening test resulted 
in a no observed adverse effect level (NOAEL) of 1,125 mg/kg/day in 
mice and it was determined that oral administration of the test 
material did not affect maternal mortality, the number of viable 
litters, length of gestation, litter size, percent survival of the pups 
or birth weight or weight gained by the pups. No quantitative or 
qualitative evidence of susceptibility was observed from any of the 
currently available toxicological data.
    3. No reproductive parameters were affected in rat and mice treated 
dermally at doses up to 2,000 and 4,000 mg/kg/day, respectively.
    4. No evidence of treatment related clinical signs of neurotoxicity 
was observed in the available toxicological studies. EPA concluded that 
the developmental neurotoxicity study is not required.
    5. The highly conservative dietary exposure assessment using 
default assumptions would not underestimate the risk to infants and 
children.

VIII. Determination of Safety for U.S. Population

    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. 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.
    Residues of concern are not anticipated for dietary exposure (food 
and drinking water) or for residential exposure (inhalation and dermal) 
from the use of TEA as an inert ingredient in pesticide products. The 
toxicology data indicate that TEA does not pose an acute risk. Chronic 
risk was assessed by comparing aggregate exposure to TEA to a cPAD of 
1.70 mg/kg/day (based on the subchronic oral rat study with a NOAEL of 
170 mg/kg/day and a safety/uncertainty factor of 100X). Utilizing the 
highly conservative aggregate exposure assessment described above, the 
resulting chronic exposure estimates do not exceed the Agency's level 
of concern (children 1-2 years were the most highly exposed population 
with the chronic exposure estimates occupying 26.6% of the cPAD). In 
addition, this highly conservative exposure assessment is protective of 
any possible non-occupational exposures to TEA, as it results in 
exposure estimates orders of magnitude greater than the high-end 
exposure estimates for residential uses of pesticides routinely used by 
EPA's Office of Pesticide Programs.

[[Page 12620]]

    Taking into consideration all available information on TEA, 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 TEA residues. Therefore, the establishment of an exemption 
from the requirement of a tolerance under 40 CFR 180.920 for residues 
of TEA when used as an inert ingredient in pesticide formulations 
applied to growing crops, is safe under section 408(q) of the FFDCA.

IX. Other Considerations

A. Analytical Method

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. Existing Exemptions

    Triethanolamine has an existing exemption from the requirement of a 
tolerance under 40 CFR 180.920 for use as an inert ingredient in 
pesticide formulations applied before the crop emerges from the soil.

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
triethanoloamine nor have any CODEX Maximum Residue Levels (MRLs) been 
established for any food crops at this time.

X. Conclusions

    Therefore, an exemption from the requirement for a tolerance is 
established for triethanolamine when used as an inert ingredient in 
pesticide formulations applied to growing crops.

XI. 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) (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).

XII. 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: March 3, 2009.
Lois Rossi,
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.  180.920, the table is amended by revising the entry for 
``Triethanolamine'' to read as follows:


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

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Triethanolamine (CAS Reg. No.                         Stabilizer,
 102-71-6)                                             inhibitor
                                * * * * *
------------------------------------------------------------------------


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[FR Doc. E9-6263 Filed 3-24-09; 8:45 am]
BILLING CODE 6560-50-S


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