[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22844]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2010-0271; FRL: 8882-4]
Lipase, Triacylglycerol; Exemption From the Requirement of a
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of lipase, triacylglycerol (CAS Reg. No.
9001-62-1) when used as a component of food contact sanitizing
solutions applied to all food contact surfaces in public eating places,
dairy-processing equipment, and food-processing equipment and utensils
at a maximum level in the end-use concentration of 500 parts per
million (ppm). Novozymes North America, 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 lipase, triacylglycerol.
DATES: This regulation is effective September 7, 2011. Objections and
requests for hearings must be received on or before November 7, 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-2010-0271 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)
FOR FURTHER INFORMATION CONTACT: Elizabeth Fertich, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number: (703) 347-8560 e-mail address:
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
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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
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-2010-0271 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
November 7, 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-2010-0271, 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 February 25, 2011 (76 FR 1058) (FRL-
8863-4), EPA issued a notice pursuant to section 408 of FFDCA, 21
U.S.C. 346a, announcing the filing of a pesticide petition (PP 0E7697)
by Novozymes North America, Inc., P.O. Box 576, 77
Perry Chapel Church Road, Franklinton, NC 27525. The petition requested
that 40 CFR 180.950 be amended by establishing an exemption from the
requirement of a tolerance for residues of lipase, triacylglycerol (CAS
Reg. No. 9001-62-(1), Hereafter referred to as triacylglycerol lipase,
when used as an inert ingredient as an aid in the removal of lipids in
antimicrobial pesticide formulations applied to food contact surfaces.
That notice referenced a summary of the petition prepared by Novozymes
North America, 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.
Based upon review of the data supporting the petition, EPA has
modified the exemption requested by establishing an exemption from the
requirement under 40 CFR 180.940(a) with a limitation of
triacylglycerol lipase of 500 ppm in final pesticide formulations. This
limitation is based on the Agency's risk assessment which can be found
at http://www.regulations.gov in document ``PC Code 908800: Lipase,
triacylglycerol lipase (CAS Reg. No. 9001-62-1); Human Health Risk
Assessment and Ecological Effects Assessment to the Support Proposed
Exemption from the Requirement of a Tolerance When Used as an Inert
Ingredient in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
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
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 triacylglycerol lipase
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with
triacylglycerol lipase follows.
A. Toxicological Profile
EPA has evaluated the available toxicity data and considered their
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
The toxicology database is adequate to support the use of
triacylglycerol lipase as a component of food contact sanitizing
solutions. Triacylglycerol lipases are a class of lipase enzymes that
catalyze the hydrolysis of fatty acid ester bonds in the
triacylglycerol molecule in aqueous solutions. Like other enzymes,
triacylglycerol lipase is a protein that acts as a catalyst to increase
the rate of chemical reactions and is produced by all living cells.
The acute toxicity studies of triacylglycerol lipase show low
toxicity. The test material is not acutely toxic by the oral or
inhalation routes. It is also not a dermal irritant, eye irritant or
Triacylglycerol lipase was also not toxic in short-term studies. In
a 2 week study, Sprague-Dawley rats were dosed once daily by gavage at
dose levels of 0, 0.2, 2 or 10 grams kilogram day (g/kg/day) and in a
second 13 week study, Sprague-Dawley rats were administered the same
test material at dose levels of 0, 0.2, 1 and 5 g/kg/day. There were no
treatment related clinical signs, nor any toxicity seen in either
In a 2-generation reproductive toxicity study in Sprague-Dawley
rats, triacylglycerol lipase was administered orally to 5 treatment
groups of rats. Each group contained 24 males and 24 females and
received diets containing 0, 0.5, 1.5 or 5.0% of the test material by
weight in the diet (equivalent to 0, 500, 1,500 or 5,000 milligrams
kilogram body weight day (mg/kg/bw/day). There were no effects of
treatment with the test material on either F0 or
F1 fertility, general reproductive performance and systemic
toxicity at exposure levels of up to 5,000 mg/kg/bw/day. No treatment
related effects were observed on the developmental parameters evaluated
in this study at doses up to and including 5,000 mg/kg/day.
As with other proteins, inhalation exposure to lipases may lead to
potential respiratory (Type 1) allergy.
Specific information on the studies received and the nature of the
adverse effects caused by triacylglycerol lipase 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 the document ``PC Code 908800: Lipase,
triacylglycerol (CAS Reg. No. 9001-62-1); Human Health Risk Assessment
and Ecological Effects Assessment to the Support Proposed Exemption
from the Requirement of a Tolerance When Used
as an Inert Ingredient in Pesticide Formulations,'' p. 7 in docket ID
B. Toxicological Points of Departure/Levels of Concern
Triacylglycerol lipase is not toxic by the oral or dermal routes.
No toxicity endpoint of concern was identified in the available
toxicity studies. There were also no adverse effects observed in acute
toxicity studies and short-term toxicity studies at doses up to 10 kg/
day. No toxicity was observed in a 2-generation reproductive toxicity
study in rats at doses up to 5% (equivalent to 5,000 mg/kg/bw/day). A
quantitative risk assessment for the dietary and residential exposure
from the oral and dermal routes is not necessary since no endpoint of
concern was identified in the available database. Inhalation exposure
to enzymes, including triacylglycerol lipase, may lead to potential
respiratory (Type 1) allergy.
C. Exposure Assessment
Lipases are necessary for lipid metabolism and are found in almost
all living organisms, as well as being regularly consumed in foods. As
with other enzymes, lipases are common in fresh and processed foods and
are consumed by humans every day.
No hazard endpoint of concern was identified for the acute and
chronic dietary assessment (food and drinking water), or for the short,
intermediate, and long term dermal residential assessments, therefore,
acute and chronic dietary and short-, intermed- iate-, and long-term
dermal residential exposure assessments were not performed.
Residential (dermal and inhalation) exposures to triacylglycerol
lipase from home uses, such as components of laundry detergents and
food contact surface sanitizing solutions, are also possible. The
limitation of 500 ppm for tricylglycerol lipase in final pesticide
formulations will result in exposures several orders of magnitude at or
below 1 nanogram per cubic meter (ng/m\3\), the common level at which
allergic symptoms have not been observed.
D. Cumulative Effects From Substances With a Common Mechanism of
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 triacylglycerol lipase to share a common
mechanism of toxicity with any other substances, and triacylglycerol
lipase does not appear to produce a toxic metabolite produced by other
substances. For the purposes of this tolerance action, therefore, EPA
has assumed that triacylglycerol lipase 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.
E. Safety Factor for Infants and Children
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.
No developmental toxicity studies are available in the database.
However, there were no adverse effects in a 2-generation reproductive
toxicity study in rats at doses up to 5% (equivalent to 5,000 mg/kg/bw/
day). Also no systemic toxicity was observed at doses up to 10 g/kg/day
in a 2-week, sub-acute oral toxicity study in rats and no systemic
toxicity observed at 5 g/kg/day in a 13-week oral toxicity study in
rats. No systemic toxicity was observed in laboratory animals at high
doses, indicating relatively low hazard potential. There was no
evidence of clinical signs of neurotoxicity; therefore, developmental
neurotoxicity study is not required. In addition, no evidence of
immunotoxicity was seen in the database; therefore, an immunotoxicity
study is not required. In terms of hazard, there are low concerns and
no residual uncertainties regarding prenatal and/or postnatal toxicity.
Based on this information, there is no concern at this time for
increased sensitivity to infants and children to triacylglycerol lipase
when used as an inert ingredient in pesticide formulations 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.
F. Aggregate Risks and Determination of Safety
Given the lack of concern for hazard posed by triacylglycerol
lipase, EPA concludes that there are no dietary or aggregate dietary/
non-dietary risks of concern as a result of exposure to triacylglycerol
lipase in food and water or from residential exposure. Residues of
concern are not anticipated for dietary exposure (food and drinking
water) or for residential exposure (dermal) from the use of
triacylglycerol lipase as an inert ingredient in pesticide products. As
discussed in this unit, EPA expects aggregate exposure to
triacylglycerol lipase to pose no appreciable dietary risk given that
the data show a lack of systemic toxicity at doses up to 5,000 mg/kg/
day and a lack of any apparent developmental effects. Inhalation
exposure to enzymes, including triacylglycerol lipase, may lead to
potential respiratory (Type 1) allergy. Although there is no well-
defined threshold for the induction of sensitization to the potential
allergic effects from exposure to enzymes such as triacylglycerol
lipase, allergic symptoms have not been observed when inhalation
exposure levels are at or below 1 ng/m\3\. A limitation of 500 ppm of
triacylglycerol lipase in final pesticide formulations will result in
exposures several orders of magnitude below 1 ng/m\3\. This limitation
will ensure that inhalation exposures to triacylglycerol lipase will be
below the threshold for adverse respiratory effects and is protective
of any potential respiratory allergy concerns.
Taking into consideration all available information on
triacylglycerol lipase at a maximum of 500 ppm in final pesticide
formulations, EPA has determined that there is a reasonable certainty
that no harm to any population subgroup will result from aggregate
exposure to triacylglycerol lipase under reasonably foreseeable
circumstances. Therefore, the establishment of an exemption from
tolerance under 40 CFR 180.940(a) for residues of triacylglycerol
lipase when used as a component of food contact sanitizing solutions
applied to all food contact surfaces in public eating places, dairy-
processing equipment, and food-processing equipment and utensils at a
maximum level in the end-use concentration of 500 ppm 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 not establishing a numerical tolerance for residues of
triacylglycerol lipase in or on any food commodities. EPA is
establishing a limitation on the amount of triacylglycerol lipase that
may be used in pesticide formulations. That limitation will be enforced
through the pesticide registration process under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et
seq. EPA will not register any pesticide for sale or distribution for
which the final end use concentration of triacylglcyerol lipase in
antimicrobial, food contact surface sanitizing solutions would exceed
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 triacylglycerol lipase.
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.940(a) for residues of lipase,
triacylglycerol (CAS Reg. No 9001-62-1) when used as a component of
food contact sanitizing solutions applied to all food contact surfaces
in public eating places, dairy-processing equipment, and food-
processing equipment and utensils at a maximum level in the end-use
concentration of 500 ppm.
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
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
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
Dated: August 26, 2011.
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
2. In Sec. 180.940(a), the table is amended by adding alphabetically
the following inert ingredient to read as follows:
Sec. 180.940 Tolerance exemptions for active and inert ingredients
for use in antimicrobial formulations (Food contact surface sanitizing
* * * * *
(a) * * *
Pesticide chemical CAS Reg. No. Limits
* * * * * * *
Lipase, triacylglycerol....... 9001-62-1 When ready for use,
concentration is not
to exceed 500 ppm.
* * * * * * *
* * * * *
[FR Doc. 2011-22844 Filed 9-6-11; 8:45 am]
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