20542 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

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). 

VII. 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: April 1, 2011. 

Daniel J. Rosenblatt, 

Acting 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. Section 180.593 is amended by: 

■ i. Revising the introductory text in 

paragraph (a); 

■ ii. Removing the commodities 

‘‘Cucumber,’’ ‘‘Grape’’ and ‘‘Strawberry’’ 

from the table in paragraph (a); 

■ iii. Revising the entry ‘‘Vegetable, 

cucurbit subgroup 9A’’ to read ‘‘Melon 

subgroup 9A’’ in the table; and 

■ iv. Alphabetically adding the 

following commodities to the table in 

paragraph (a) to read as follows: 

§ 180.593 Etoxazole; tolerances for 

residues. 

(a) General. Tolerances are 

established for residues of etoxazole, 

including its metabolites and 

degradates, in or on the commodities in 

the table below. Compliance with the 

tolerance levels specified below is to be 

determined by measuring only etoxazole 

(2-(2,6-difluorophenyl)-4-[4-(1,1- 

dimethylethyl)-2-ethoxyphenyl]-4,5- 

dihydrooxazole) in or on the 

commodity. 

Commodity Parts per 

million 

* * * * * 

Avocado .................................. 0 .20 

Berry, low growing, subgroup 

13–07G ............................... 0 .50 

Caneberry subgroup 13–07A 1 .5 

Canistel ................................... 0 .20 

* * * * * 

Fruit, small vine climbing, except fuzzy kiwifruit, subgroup 13–07F ...................... 0 .50 

Commodity Parts per 

million 

* * * * * 

Mango ..................................... 0 .20 

Melon subgroup 9A ................ 0 .20 

* * * * * 

Papaya .................................... 0 .20 

Pepper/eggplant subgroup 8– 

10B ...................................... 0 .20 

* * * * * 

Sapodilla ................................. 0 .20 

Sapote, black .......................... 0 .20 

Sapote, mamey ...................... 0 .20 

* * * * * 

Squash/cucumber subgroup 

9B ........................................ 0 .02 

Star apple ............................... 0 .20 

* * * * * 

Tea, dried * ............................. 15 

* * * * * 

* There are currently no U.S. registrations 

for tea as of April 13, 2011. 

* * * * * 

[FR Doc. 2011–8550 Filed 4–12–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0274; FRL–8868–4] 

Escherichia coli O157:H7 Specific 

Bacteriophages; Temporary Exemption 

From the Requirement of a Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: This regulation establishes a 

temporary exemption from the 

requirement of a tolerance for residues 

of lytic bacteriophages that are specific 

to Escherichia coli O157:H7, sequence 

negative for shiga toxins I and II, and 

grown on atoxigenic host bacteria when 

applied/used on food contact surfaces in 

food processing plants in accordance 

with the terms of Experimental Use 

Permit (EUP) No. 74234–EUP–2. 

Intralytix, Inc. submitted a petition to 

EPA under the Federal Food, Drug, and 

Cosmetic Act (FFDCA), requesting the 

temporary tolerance exemption. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of lytic bacteriophages that 

are specific to Escherichia coli O157:H7, 

sequence negative for shiga toxins I and 

II, and grown on atoxigenic host 

bacteria. The temporary tolerance 

exemption expires on April 1, 2013. 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20543 

DATES: This regulation is effective April 

13, 2011. Objections and requests for 

hearings must be received on or before 

June 13, 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–2010–0274. 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: 

Tracy Lantz, Antimicrobials Division 

(7510P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–6415; e-mail address: 

lantz.tracy@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:// 

www.gpoaccess.gov/ecfr. 

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–2010–0274 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 June 13, 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–2010–0274, by one of 

the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the on-line 

instructions for submitting comments. 

• Mail: Office of Pesticide Programs 

(OPP) Regulatory Public Docket (7502P), 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001. 

• Delivery: OPP Regulatory Public 

Docket (7502P), Environmental 

Protection Agency, Rm. S–4400, One 

Potomac Yard (South Bldg.), 2777 S. 

Crystal Dr., Arlington, VA. Deliveries 

are only accepted during the Docket 

Facility’s normal hours of operation 

(8:30 a.m. to 4 p.m., Monday through 

Friday, excluding legal holidays). 

Special arrangements should be made 

for deliveries of boxed information. The 

Docket Facility telephone number is 

(703) 305–5805. 

II. Background and Statutory Findings 

In the Federal Register of May 5, 2010 

(75 FR 24692) (FRL–8820–7), EPA 

issued a notice pursuant to section 

408(d)(3) of FFDCA, 21 U.S.C. 

346a(d)(3), announcing the filing of a 

pesticide tolerance petition (PP 9G7585) 

by Intralytix, Inc., 701 East Pratt Street, 

Baltimore, MD 21202. The petition 

requested that 40 CFR part 180 be 

amended by establishing a temporary 

exemption from the requirement of a 

tolerance for residues of Escherichia coli 

O157:H7 Specific Bacteriophages. This 

notice referenced a summary of the 

petition prepared by the petitioner 

Intralytix, Inc., which is available in the 

docket, http://www.regulations.gov. 

There were no comments received in 

response to the notice of filing. 

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 exemption is ‘‘safe.’’ 

Section 408(c)(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. Pursuant to 

section 408(c)(2)(B) of FFDCA, in 

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in section 

408(b)(2)(C) of FFDCA, which require 

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. * * *’’ 

Additionally, section 408(b)(2)(D) of 

FFDCA requires that 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 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 


emcdonald on DSK2BSOYB1PROD with RULES
20544 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

exposures that occur as a result of 

pesticide use in residential settings. 

III. 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. 

Phages are naturally occurring viruses 

infecting bacteria. They are found in soil 

and water and in association with plants 

and animals, including humans. 

Bacteriophages are obligate parasites of 

bacteria, which means they attach to, 

infect, and reproduce in bacteria. Phages 

are host-specific for bacteria, with 

specific bacteriophages attacking only 

one bacterial species and most 

frequently only one strain within a 

bacterial species. As such, phages do 

not attack other beneficial bacteria. In 

addition, there is no evidence for 

bacteriophages infecting any other life 

form, including humans, except 

bacteria. Thus, non-target organisms, 

such as mammals, birds, fish, plants, 

and other wildlife, are not affected by 

exposure to bacteriophages. Humans 

and other animals commonly consume 

bacteriophages as they are abundantly 

found in water, on plant surfaces, and 

in foods such as ground beef, pork 

sausage, chicken, oysters, cheese, fresh 

mushrooms, and lettuce. In addition, 

phages are common commensals of the 

human gut and likely play an important 

role in regulating populations of various 

bacteria in the gastrointestinal tract. As 

cited in public literature, phages have 

been used for more than 80 years as 

therapeutic agents with no ill effects 

and are active against bacteria that cause 

many infections and human diseases. 

Since bacteriophage do not infect 

humans, there is not a human health 

risk concern from the bacteriophages 

themselves. The potential concerns for 

human health risk from bacteriophages 

relate to their interaction with the 

bacteria they infect. If bacteriophage do 

not lyse (i.e., break open) the bacterial 

cell they infect, there is a possibility the 

cell will survive the infection and 

incorporate any DNA carried by the 

bacteriophage in its genome (i.e. 

lysogenize). If genes for shigatoxins I 

and II, often associated with pathogenic 

strains of Escherichia coli O157:H7, are 

carried by a lysogenized bacteriophage 

into an atoxigenic Escherichia coli, 

there is a possibility, in theory, to 

convert a commensal and harmless 

bacterium into a pathogen. This 

theoretical risk is handled in three ways 

for this tolerance exemption: (1) Only 

lytic bacteriophage are used; (2) 

bacteriophage covered by this tolerance 

exemption are DNA sequenced to 

ensure they do not have the ability to 

convey shigatoxins I and II; and (3) host 

bacteria used to grow bacteriophage also 

are atoxigenic in that they do not carry 

DNA sequences capable of shigatoxin 

production. 

To address the infectivity and toxicity 

endpoints for oral, pulmonary, and 

injection exposures, the petitioner 

provided publicly available information 

documenting a lack of mammalian 

toxicity or infectivity associated with 

bacteriophages due to the specificity of 

bacteriophages attachment and attack to 

a narrow range of bacterial strains. As a 

result, the public literature 

demonstrates that phages pose little to 

no risk to humans even with the known 

wide exposure in food and the 

environment. 

Based on the published literature and 

information submitted in accordance 

with the Tier I toxicology data 

requirements set forth in 40 CFR 

158.2140(c), the Tier II and Tier III 

toxicology data requirements also set 

forth therein were not triggered and, 

therefore, not required in connection 

with this action. 

IV. 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 nonoccupational 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). 

A. Dietary Exposure 

1. Food. All phages, including those at 

issue in this action, are similar in nature 

in that they are host-specific, attacking 

only bacteria. Published literature 

submitted by the registrant, and other 

publically available literature, indicate 

that humans are exposed to phages 

daily, and these phages are commonly 

found in humans, having no known 

adverse effects. Indeed, humans and 

other animals routinely consume phages 

when they eat food such as raw produce 

and cheese. For example, it is reported 

that 1,000 (103) to 5 × 105 phages can 

be isolated routinely per gram (g) of 

high quality cheese. Pathogenic 

microorganisms are often found in 

foods; therefore, it is not surprising that 

one study found Escherichia coli and 

coliphages in 11 of 12 foods purchased 

at retail markets. In this study, 10 

purchases of each of the 12 foods were 

made. All 10 of the fresh ground beef 

purchases were contaminated with 

Escherichia coli, and all 10 contained 

coliphages. In addition to ground beef, 

Escherichia coli and coliphages were 

found in chicken, fresh pork, fresh 

oyster, fresh mushrooms, lettuce, 

chicken pot pie, biscuit dough, deli loaf, 

deli roasted turkey, and package roasted 

chicken. Another example of phages in 

food has been Propionibacterium 

freundenreichii phage found in 

concentrations as high as 1.4 × 106/gm 

of swiss cheese. 

The use of the bacteriophages covered 

by this tolerance in food processing 

plants on food contact surfaces could 

result in some residues of these 

bacteriophages on food. The Agency 

anticipates that food coming into 

contact with these surfaces could get 

residues of the phages on them and 

foods with Escherichia coli O157:H7 

may end up with more phages on them 

as the bacteriophages covered by this 

tolerance exemption infect the bacteria 

and produce progeny. 

2. Drinking water exposure. The 

Escherichia coli bacteriophages covered 

by this tolerance exemption are not 

intended for use in drinking water, nor 

are the approved uses likely to result in 

these bacteriophages reaching surface 

water or ground water that might be 

used as drinking water. Use sites are 

only for food processing facilities. 

B. Other Non-Occupational Exposure 

Since Escherichia coli bacteriophages 

subject to this tolerance exemption are 

only intended to be applied to food 

contact surfaces in food processing 

plants, the potential for nonoccupational, non-dietary exposures 

(i.e., dermal and inhalation exposures) 

to these phages by the general 

population, including infants and 

children, is highly unlikely. 

V. 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 lytic 

bacteriophages that are specific to 

Escherichia coli O157:H7, sequence 

negative for shiga toxins I and II, and 

grown on atoxigenic host bacteria to 


emcdonald on DSK2BSOYB1PROD with RULES
Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 20545 

share a common mechanism of toxicity 

with any other substances. Moreover, 

bacteriophage that meet these 

conditions do not appear to produce a 

toxic metabolite produced by other 

substances. Therefore, for the purposes 

of this action, EPA has assumed that 

lytic bacteriophages that are specific to 

Escherichia coli O157:H7, sequence 

negative for shiga toxins I and II, and 

grown on atoxigenic host bacteria do 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. 

VI. Determination of Safety for U.S. 

Population, Infants and Children 

A. U.S. Population 

Based on the fact that bacteriophages 

are host-specific and do not cause harm 

to human health, except in theoretical 

instances that the Agency is avoiding 

through its conditions on this 

exemption, there is reasonable certainty 

that no harm will result to the U.S. 

population, including infants and 

children, from aggregate exposure to 

residues of lytic bacteriophages that are 

specific to Escherichia coli O157:H7, 

sequence negative for shiga toxins I and 

II, and grown on atoxigenic host 

bacteria. This includes all anticipated 

dietary exposures and all other 

exposures for which there is reliable 

information. 

B. Infants and Children 

FFDCA section 408 (b)(2)(C) provides 

that EPA shall apply an additional 

tenfold margin of exposure (MOE) for 

infants and children in the case of 

threshold effects to account for prenatal 

and postnatal toxicity and the 

completeness of the data base on 

toxicity and exposure, unless EPA 

determines that a different MOE will be 

safe for children. MOEs, which are often 

referred to as uncertainty (safety) 

factors, are incorporated into EPA risk 

assessments either directly, or through 

the use of a MOE analysis or by using 

uncertainty factors in calculating a dose 

level that poses no appreciable risk. As 

previously mentioned in the 

toxicological profile, humans, including 

infants and children, have been exposed 

to phages generally through food and 

water, where they are commonly found, 

and through decades of therapeutic use, 

with no known or reported adverse 

effects. Based on all available 

information, the Agency concludes that 

lytic bacteriophages that are specific to 

Escherichia coli O157:H7, sequence 

negative for shiga toxins I and II, and 

grown on atoxigenic host bacteria are 

non-toxic to mammals, including 

infants and children. Because there are 

no threshold effects of concern to 

infants, children, and adults when lytic 

bacteriophages that are specific to 

Escherichia coli O157:H7, sequence 

negative for shiga toxins I and II, and 

grown on atoxigenic host bacteria are 

used as labeled, the Agency concludes 

that the additional MOE is not necessary 

to protect infants and children and that 

not adding any additional MOE will be 

safe for infants and children. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes since the 

Agency is establishing an exemption 

from the requirement of a tolerance 

without any numerical limitation. 

B. International Residue Limits 

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 lytic bacteriophages that are specific 

to Escherichia coli O157:H7, sequence 

negative for shiga toxins I and II, and 

grown on atoxigenic host bacteria. 

C. Revisions to Petitioned-for Tolerances 

In its petition PP 9G7585, Intralytix 

requested that the Agency establish a 

tolerance exemption for residues of 

Escherichia coli O157:H7 specific 

bacteriophages. The Agency is 

narrowing the scope of the tolerance 

exemption to residues of lytic 

bacteriophages that are specific to 

Escherichia coli O157:H7, sequence 

negative for shiga toxins I and II, and 

grown on atoxigenic host bacteria 

because that is the category of 

bacteriophages for which the Agency 

can make a safety finding. 

VIII. Conclusion 

The Agency concludes that there is a 

reasonable certainty that no harm will 

result to the U.S. population, including 

infants and children, from aggregate 

exposure to residues of lytic 

bacteriophages that are specific to 

Escherichia coli O157:H7, sequence 

negative for shiga toxins I and II, and 

grown on atoxigenic host bacteria, 

including all anticipated dietary 

exposures and all other exposures for 

which there is reliable information, 

when used according to label directions, 

as a microbial on food contact surfaces 

in food processing plants. Therefore, a 

temporary exemption is established for 

residues of lytic bacteriophages that are 

specific to Escherichia coli O157:H7, 

sequence negative for shiga toxins I and 

II, and grown on atoxigenic host 

bacteria. 

IX. 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, 


emcdonald on DSK2BSOYB1PROD with RULES
20546 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Rules and Regulations 

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). 

X. 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: April 5, 2011. 

Steven Bradbury, 

Director, Office of Pesticide Programs. 

Therefore, 40 CFR part 180 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. Add § 180.1301 to subpart D to read 

as follows: 

§ 180.1301 Escherichia coli O157:H7 

specific bacteriophages; temporary 

exemption from the requirement of a 

tolerance. 

A temporary exemption from the 

requirement of a tolerance is established 

for residues of lytic bacteriophages that 

are specific to Escherichia coli O157:H7, 

sequence negative for shiga toxins I and 

II, and grown on atoxigenic host bacteria 

when used/applied on food contact 

surfaces in food processing plants in 

accordance with the terms of 

Experimental Use Permit (EUP) No. 

74234–EUP–2. This temporary 

exemption expires on April 1, 2013. 

[FR Doc. 2011–8712 Filed 4–12–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 300 

[EPA–HQ–SFUND–1983–0002; FRL–9291–6] 

National Oil and Hazardous Substance 

Pollution Contingency Plan; National 

Priorities List: Deletion of the 

Spiegelberg Landfill Superfund Site 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: The U.S. Environmental 

Protection Agency (EPA) Region 5 is 

publishing a direct final Notice of 

Deletion of the Spiegelberg Landfill 

Superfund Site (Site), located in Green 

Oak Township, Michigan from the 

National Priorities List (NPL). The NPL, 

promulgated pursuant to Section 105 of 

the Comprehensive Environmental 

Response, Compensation, and Liability 

Act (CERCLA) of 1980, as amended, is 

an appendix to the National Oil and 

Hazardous Substances Pollution 

Contingency Plan (NCP). This direct 

final deletion is being published by EPA 

with the concurrence of the State of 

Michigan through the Michigan 

Department of Environmental Quality 

(MDEQ), because EPA has determined 

that all appropriate response actions 

under CERCLA have been completed. 

However, this deletion does not 

preclude future actions under 

Superfund. 

DATES: This direct final deletion is 

effective June 13, 2011 unless EPA 

receives adverse comments by May 13, 

2011. If adverse comments are received, 

EPA will publish a timely withdrawal of 

the direct final deletion in the Federal 

Register informing the public that the 

deletion will not take effect. 

ADDRESSES: Submit your comments, 

identified by Docket ID no. EPA–HQ– 

SFUND–1983–0002, by one of the 

following methods: 

• http://www.regulations.gov: Follow 

on-line instructions for submitting 

comments. 

• E-mail: Howard Caine, Remedial 

Project Manager, at 

caine.howard@epa.gov or Cheryl Allen, 

Community Involvement Coordinator, at 

allen.cheryl@epa.gov. 

• Fax: Gladys Beard, Deletion Process 

Manager, at (312) 697–2077. 

• Mail: Howard Caine, Remedial 

Project Manager, U.S. Environmental 

Protection Agency (SR–6J), 77 W. 

Jackson Boulevard, Chicago, IL 60604, 

(312) 353–9685; or Cheryl Allen, 

Community Involvement Coordinator, 

U.S. Environmental Protection Agency 

(SI–7J), 77 W. Jackson Boulevard, 

Chicago, IL 60604, (312) 353–6196 or 

(800) 621–8431. 

• Hand delivery: Cheryl Allen, 

Community Involvement Coordinator, 

U.S. Environmental Protection Agency 

(SI–7J), 77 West Jackson Boulevard, 

Chicago, IL 60604. Such deliveries are 

only accepted during the docket’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. The 

normal business hours are Monday 

through Friday, 8:30 a.m. to 4:30 p.m., 

excluding Federal holidays. 

Instructions: Direct your comments to 

Docket ID no. EPA–HQ–SFUND–1983– 

0002. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through http:// 

www.regulations.gov or e-mail. The 

http://www.regulations.gov Web site is 

an ‘‘anonymous access’’ system, which 

means EPA will not know your identity 

or contact information unless you 

provide it in the body of your comment. 

If you send an e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the comment 


emcdonald on DSK2BSOYB1PROD with RULES