55264 Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 

contact the COTP or a designated 

representative to obtain permission to 

do so. Vessel operators given permission 

to enter or operate in the safety zone 

must comply with all directions given to 

them by the COTP or a designated 

representative. Persons and vessels may 

request permission to enter the safety 

zone on VHF–16 or through the 24-hour 

Command Center at telephone (415) 

399–3547. 

(d) Effective period. This section is 

effective from 11 a.m. through 9 p.m. on 

September 17, 2011. 

Dated: August 19, 2011. 

Cynthia L. Stowe, 

Captain, U.S. Coast Guard, Captain of the 

Port San Francisco. 

[FR Doc. 2011–22773 Filed 9–6–11; 8:45 am] 

BILLING CODE 9110–04–P 

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. 

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/textidx?&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 


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Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 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-adverseeffect-level (NOAEL) and the lowestobserved-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 


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55266 Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 

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-, intermediate-, 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/m3), 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 welldefined 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/m3. A limitation of 500 ppm 

of triacylglycerol lipase in final 

pesticide formulations will result in 

exposures several orders of magnitude 

below 1 ng/m3. 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. 


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Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 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] 

■ 1. The authority citation for part 180 

continues to read as follows: 

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

■ 2. In § 180.940(a), the table is 

amended by adding alphabetically the 

following inert ingredient to read as 

follows: 

§ 180.940 Tolerance exemptions for active 

and inert ingredients for use in 

antimicrobial formulations (Food contact 

surface sanitizing solutions). 

* * * * * 

(a) * * * 


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55268 Federal Register / Vol. 76, No. 173 / Wednesday, September 7, 2011 / Rules and Regulations 

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 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0054; FRL–8887–4] 

Chromobacterium subtsugae Strain 

PRAA4–1T; Exemption From the 

Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes an 

exemption from the requirement of a 

tolerance for residues of 

Chromobacterium subtsugae strain 

PRAA4–1T in or on all food 

commodities when applied as an 

insecticide or miticide and used in 

accordance with good agricultural 

practices. Marrone Bio Innovations, Inc. 

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 Chromobacterium 

subtsugae strain PRAA4–1T under the 

FFDCA. 

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–2010–0054. 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 Office of 

Pesticide Programs (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: 

Jeannine Kausch, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8920; e-mail address: 

kausch.jeannine@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/textidx?&c=ecfr&tpl=/ecfrbrowse/Title40/ 

40tab_02.tpl. To access the harmonized 

test guidelines referenced in this 

document electronically, please go to 

http://www.epa.gov/ocspp and select 

‘‘Test Methods and Guidelines.’’ 

C. How can I file an objection or hearing 

request? 

Under FFDCA section 408(g), 21 

U.S.C. 346a(g), 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–2010–0054 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–2010–0054, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: 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. 


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