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[Federal Register Volume 76, Number 173 (Wednesday, September 7, 2011)]
[Rules and Regulations]
[Pages 55264-55268]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22844]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2010-0271; FRL: 8882-4]

Lipase, Triacylglycerol; 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 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) 
305-5805.

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: 
fertich.elizabeth@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://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

[[Page 55265]]

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-
2010-0271.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. * * *''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for 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 
children.
    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 
dermal sensitizer.
    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 
study.
    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

[[Page 55266]]

as an Inert Ingredient in Pesticide Formulations,'' p. 7 in docket ID 
number EPA-HQ-OPP-2010-0271.

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 
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 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.

[[Page 55267]]

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 
500 ppm.

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.

VI. Conclusions

    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 
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: August 26, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

0
2. In Sec.  180.940(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 
solutions).

* * * * *
    (a) * * *

[[Page 55268]]

------------------------------------------------------------------------
      Pesticide chemical          CAS Reg. No.            Limits
------------------------------------------------------------------------
 
                              * * * * * * *
Lipase, triacylglycerol.......         9001-62-1  When ready for use,
                                                   the end-use
                                                   concentration is not
                                                   to exceed 500 ppm.
 
                              * * * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2011-22844 Filed 9-6-11; 8:45 am]
BILLING CODE 6560-50-P
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