Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Rules and Regulations 66187 

more flexible staffing may be the most 

rational option. 

II. Explanation of Changes From 

Proposed Rule 

The final rule includes the following 

additional changes to the proposed rule. 

Paragraph 241.1(a) has been revised to 

clarify that the operation or staffing of 

a Post Office by non-postmaster 

personnel must be at the direction of the 

postmaster, and that it may include 

times when the postmaster is not 

physically present. While the proposed 

rule referred to whether a Post Office 

was ‘‘operated or managed’’ by nonpostmaster personnel, the phrase 

‘‘operated or staffed’’ better reflects the 

intended meaning that a postmaster 

would continue to manage operations at 

the Post Office, albeit possibly without 

personally operating or staffing it on a 

continuous basis. 

A sentence is added to paragraph 

241.3(a)(1)(ii) (redesignated as 

241.3(a)(1)(iii)) to clarify that these 

regulations will no longer apply to 

discontinuance actions pending as of 

December 1, 2011, that pertain to the 

conversion of a Post Office to another 

type of USPS-operated facility. 

The definition of ‘‘consolidation’’ in 

paragraph 241.3(a)(2)(iv) is revised to 

restrict the term’s definition to instances 

where a Postal Service-operated retail 

facility is replaced with a contractoroperated retail facility that reports to a 

Postal Service-operated retail facility. 

Consistent with the proposed rule, the 

term no longer encompasses situations 

where a Post Office is replaced with a 

Classified Station or Classified Branch. 

Paragraph 241.3(b)(4) is revised to 

indicate the possibility that a 

consolidated facility’s name, or a similar 

name, can be used by the succeeding 

facility, rather than suggesting an 

expectation that the former name will be 

maintained, thereby allowing for the 

range of contract- and service-specific 

circumstances that can affect such a 

determination. 

The Postal Service hereby adopts the 

following changes to 39 CFR part 241. 

List of Subjects in 39 CFR Part 241 

Organization and functions 

(government agencies), Postal Service. 

Accordingly, 39 CFR part 241 is 

amended as follows: 

PART 241—RETAIL ORGANIZATION 

AND ADMINISTRATION: 

ESTABLISHMENT, CLASSIFICATION, 

AND DISCONTINUANCE 

■ 1. The authority citation for 39 CFR 

part 241 continues to read as follows: 

Authority: 39 U.S.C. 101, 401, 403, 404, 

410, 1001. 

■ 2. In § 241.1, paragraph (a) is revised 

to read as follows: 

§ 241.1 Post offices. 

(a) Establishment. Post Offices are 

established and maintained at locations 

deemed necessary to ensure that regular 

and effective postal services are 

available to all customers within 

specified geographic boundaries. A Post 

Office may be operated or staffed by a 

postmaster or by another type of postal 

employee at the direction of the 

postmaster, including when the 

postmaster is not physically present. 

* * * * * 

■ 3. In § 241.3: 

■ a. Paragraph (a)(1)(i)(B) is revised; 

■ b. Paragraph (a)(1)(ii) is redesignated 

as paragraph (a)(1)(iii), and new 

paragraph (a)(1)(ii) is added; 

■ c. Newly redesignated paragraph 

(a)(1)(iii) is revised; 

■ d. Paragraph (a)(2)(iv) is revised; 

■ e. Paragraph (b)(2)(i) is revised; 

■ f. Paragraph (b)(4) is revised; and 

■ g. Paragraph (c)(2) is revised. 

The revisions and additions read as 

follows: 

§ 241.3 Discontinuance of USPS-operated 

retail facilities. 

(a) * * * 

(1) * * * 

(i) * * * 

(B) Combine a USPS-operated Post 

Office, station, or branch with another 

USPS-operated retail facility, or 

(ii) The conversion of a Post Office 

into, or the replacement of a Post Office 

with, another type of USPS-operated 

retail facility is not a discontinuance 

action subject to this section. A change 

in the staffing of a Post Office such that 

it is staffed only part-time by a 

postmaster, or not staffed at all by a 

postmaster, but rather by another type of 

USPS employee, is not a discontinuance 

action subject to this section. 

(iii) The regulations in this section are 

mandatory only with respect to 

discontinuance actions for which initial 

feasibility studies have been initiated on 

or after July 14, 2011. Unless otherwise 

provided by responsible personnel, the 

rules under § 241.3 as in effect prior to 

July 14, 2011 shall apply to 

discontinuance actions for which initial 

feasibility studies have been initiated 

prior to July 14, 2011. Discontinuance 

actions pending as of December 1, 2011, 

that pertain to the conversion of a Post 

Office to another type of USPS-operated 

facility are no longer subject to these 

regulations. 

(2) * * * 

(iv) ‘‘Consolidation’’ means an action 

that converts a Postal Service-operated 

retail facility into a contractor-operated 

retail facility. The resulting contractoroperated retail facility reports to a Postal 

Service-operated retail facility. 

* * * * * 

(b) * * * 

(2) * * * 

(i) In a consolidation, the ZIP Code for 

the replacement contractor-operated 

retail facility is the ZIP Code originally 

assigned to the discontinued facility. 

* * * * * 

(4) Name of facility established by 

consolidation. If a USPS-operated retail 

facility is consolidated by establishing 

in its place a contractor-operated 

facility, the replacement unit can be 

given the same name of the facility that 

is replaced, if appropriate in light of the 

nature of the contract and level of 

service provided. 

(c) * * * 

(2) Consolidation. The proposed 

action may include a consolidation of 

USPS-operated retail facilities. A 

consolidation arises when a USPSoperated retail facility is replaced with 

a contractor-operated retail facility. 

* * * * * 

Stanley F. Mires, 

Attorney, Legal Policy and Legislative Advice. 

[FR Doc. 2011–27641 Filed 10–25–11; 8:45 am] 

BILLING CODE 7710–12–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2009–0538; FRL–8891–3] 

Bacteriophage of Clavibacter 

Michiganensis Subspecies 

Michiganensis; 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 lytic 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis in or on tomato when 

applied as a bactericide in accordance 

with good agricultural practices. On 

behalf of OmniLytics, Inc., Interregional 

Research Project Number 4 (IR–4) 

submitted a petition to EPA under the 

Federal Food, Drug, and Cosmetic Act 

(FFDCA) requesting an exemption from 


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the requirement of a tolerance. This 

regulation eliminates the need to 

establish a maximum permissible level 

for residues of lytic bacteriophage of 

Clavibacter michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis under the FFDCA. 

DATES: This regulation is effective 

October 26, 2011. Objections and 

requests for hearings must be received 

on or before December 27, 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–2009–0538. 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: 

Denise Greenway, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8263; e-mail address: 

greenway.denise@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(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–2009–0538 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 December 27, 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–HQOPP–2009–0538, 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. 

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 September 

23, 2009 (74 FR 48556) (FRL–8434–7), 

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 9E7552) 

by IR–4, Rutgers University, 500 College 

Rd. East, Suite 201W, Princeton, NJ 

08540 (on behalf of OmniLytics, Inc., 

9100 South 500 West, Sandy, UT 

84070). The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis. This notice referenced a 

summary of the petition prepared by the 

petitioner, IR–4, which is available in 

the docket via 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 exemption and 

to ‘‘ensure that there is a reasonable 

certainty that no harm will result to 

infants and children from aggregate 


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exposure to the pesticide chemical 

residue. * * *’’ 

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

FFDCA requires that EPA 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 

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. 

A. Bacteriophage Overview 

Bacteriophage, the most abundant 

group of biological entities on the 

planet, are naturally occurring viruses 

that are found in soil and water and in 

association with plants and animals, 

including humans (Refs. 1 through 8). 

Bacteriophage are obligate parasites of 

bacteria, which means they attach to, 

infect, and reproduce in bacteria, and 

are host-specific for bacteria, with 

specific bacteriophage attacking only 

one bacterial species and most 

frequently only one strain within a 

bacterial species (Refs. 9 through 11). As 

such, bacteriophage do not attack other 

beneficial bacteria. In addition, there is 

no evidence for bacteriophage infecting 

any other life form, including humans, 

except bacteria (Refs. 7, 12, and 13). 

Humans and other animals commonly 

consume bacteriophage as they are 

abundantly found in water, on plant 

surfaces, and in foods such as ground 

beef, pork sausage, chicken, oysters, 

cheese, mushrooms, and broccoli (Refs. 

3, 4, and 14 through 19). In addition, 

bacteriophage are common commensals 

of the human gut and likely play an 

important role in regulating populations 

of various bacteria in the 

gastrointestinal tract (Ref. 7). As cited in 

public literature, bacteriophage 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 

(Refs. 7, 20, and 21). 

Since 2005, bacteriophage have also 

been used in a pesticide product 

(Agriphage; EPA Reg. No. 67986–1), 

without reported incidents, to control 

particular bacterial diseases 

(Xanthomonas campestris pv. 

vesicatoria and Pseduomonas syringae 

pv. tomato) of tomato and pepper. In 

conjunction with registration of the 

aforementioned pesticide product, EPA 

established an exemption from the 

requirement of a tolerance for residues 

of bacteriophage of Xanthomonas 

campestris pv. vesicatoria and 

Pseudo ́monas syringae pv. tomato in or 

on tomato and pepper (see the Federal 

Register of December 28, 2005 (70 FR 

76704) (FRL–7753–6)). Much like the 

previously registered bacteriophage, 

OmniLytics, Inc. is proposing that 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis be applied as a pesticide 

for a very limited use-to control 

bacterial canker disease on tomato. 

B. Microbial Pesticide Toxicology Data 

Requirements 

All mammalian toxicology data 

requirements supporting the request for 

an exemption from the requirement of a 

tolerance for residues of bacteriophage 

of Clavibacter michiganensis subspecies 

michiganensis in or on tomato have 

been fulfilled with submission of valid 

studies from the public literature (Refs. 

22 and 23). 

As mentioned in Unit III.A., 

bacteriophage are viruses that only 

infect specific bacteria, a basic fact 

supported by both information 

presented in public literature and the 

absence of reported adverse effects to 

humans even with commonplace 

exposure to bacteriophage. Literature 

submitted established that 

bacteriophage have been used 

historically and through modern times 

in lieu of or to assist the action of 

antibiotics. Clinical uses encompass all 

manner of administration from 

injection/intravenous and surgical 

wound applications to topical and 

ingestible preparations. There have been 

no reports of adverse effects from such 

administrations and in other similar 

cases using controlled scientific studies. 

Also submitted were literature citations 

showing that bacteriophage are common 

and abundant in soils, are in a wide 

range of plant materials, and are 

generally present in high numbers in the 

environment (e.g., up to 1010 plaqueforming units (PFU) per liter may be 

found in non-polluted waters). Yet 

again, no adverse effects to humans 

have been reported with these types of 

potential exposure. Moreover, 

bacteriophage presence reported in 

foods and feeds ranges from 101 to 105 

PFU/100 grams (g) of meat and up to 

107 PFU/100 g of cheese without any 

known harmful effects after 

consumption of such materials. Finally, 

the petitioner noted that, during an 

extensive history of bacteriophage 

laboratory and pesticidal usage, adverse 

reports in the literature have not been 

documented and episodes of 

hypersensitivity have not occurred. 

Because bacteriophage are obligate 

bacterial parasites and are not known to 

infect humans, the only human health 

risk associated with use of 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis as a bactericide is 

potential for acquisition and production 

of microbial toxins. This acquisition 

occurs through lysogeny, which is when 

bacteriophage integrate into the genome 

of toxigenic bacterial host strains and 

pick up and transmit those genetic traits 

to other bacteria that otherwise would 

not produce toxic substances. Therefore, 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis that meet the following 

two conditions do not present this risk 

issue: 

1. Bacteriophage produced in 

Clavibacter michiganensis subspecies 

michiganensis, which has been 

sequenced and determined to be an 

atoxigenic host bacteria, and 

2. Bacteriophage possessing the 

capability to lyse host bacteria, i.e., 

completely destroy host cells during the 

viral production process, which 

precludes genetic transfer of possible 

toxins to other bacteria (Ref. 22). 

IV. Aggregate Exposure 

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 exposure. Published literature 

submitted by the petitioner, as well as 

other publicly available literature, 

indicate that bacteriophage are 

commonly associated with food and are 

therefore regularly consumed by 

humans. According to Ackermann 

(1997), these viruses have been found in 

association with ‘‘buds, leaves, root 

nodules (leguminous plants), roots, 


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rotting fruit, seeds, stems, and straw; 

crown gall tumors * * * healthy or 

diseased alfalfa, barley, beans, broccoli, 

Brussels sprouts, buckwheat, clover, 

cotton, cucumber, lucerne, mulberry, 

oats, peas, peach trees, radish, rutabaga, 

ryegrass, rye, timothy, tobacco, 

tomatoes, [and] wheat’’ (Ref. 14). 

Moreover, bacteriophage have been 

isolated from a wide range of food 

products, including ground beef, pork 

sausage, chicken, farmed freshwater 

fish, common carp, marine fish, oil 

sardines, raw skim milk, and cheese 

(Refs. 15, 16, and 24 through 27). In fact, 

several studies have suggested that 

100% of the ground beef and chicken 

meat sold at retail stores contain various 

levels of bacteriophage. For instance, 

bacteriophage were recovered from 

100% of examined fresh chicken and 

pork sausage samples and from 33% of 

delicatessen meat samples analyzed; the 

levels ranged from 3.3 × 1010 to 4.4 × 

1010 PFU/100 g of fresh chicken, up to 

3.5 × 1010 PFU/100 g of fresh pork, and 

up to 2.7 × 1010 PFU/100 g of roast 

turkey breast samples (Ref 16). Other 

studies similarly showed the 

widespread occurrence of bacteriophage 

in certain foods: 

a. 38 bacteriophage-host systems were 

isolated from 22 of 45 refrigerated 

products (Ref 27); 

b. Bacteriophage infecting fire blight 

pathogen (Erwinia amylovora) were 

isolated from apple, pear, and raspberry 

tissues and from soil samples collected 

at sites displaying fire blight symptoms 

(Ref 5); and 

c. Shellfish, which filter large 

quantities of seawater, concentrated 

both bacteria and bacteriophage (Ref 6). 

Because lytic bacteriophage of 

Clavibacter michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis are intended to be 

applied to tomatoes, it is likely that 

dietary exposure will occur; however, 

no adverse effects are expected to occur. 

Despite constant and direct food 

exposure to bacteriophage (examples 

provided in the preceding paragraph 

and in Unit III.), no adverse effects to 

humans have been reported in publicly 

available literature. Indeed, no such 

effects are expected given that 

bacteriophage, including the one at 

issue in this action, are not capable of 

infecting eukaryotic cells and are host 

specific, attacking only bacteria. 

2. Drinking water exposure. Published 

literature submitted by the petitioner, as 

well as other publicly available 

literature, indicate that, much like food, 

bacteriophage are commonly associated 

with water and are therefore regularly 

consumed by humans. According to 

Demuth et al. (1993), ‘‘Bacteriophage 

* * * have been isolated from all types 

of bacteria and from virtually any 

aquatic or terrestrial habitat where 

bacteria can exist. However, only in the 

last few years has it been recognized 

that viruses (phage) are extremely 

abundant in ocean and fresh water and 

may exceed the concentration of 

bacteria by up to 100-fold’’ (Ref. 3). 

Other studies showed that 

bacteriophage of Erwinia carotovora and 

Erwinia ananas were isolated from 

certain freshwater lakes in Florida and 

Texas (Ref. 4) and that coliphage were 

present in some samples of drinking 

water (Ref 28). 

When lytic bacteriophage of 

Clavibacter michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis are applied to tomato as 

a bactericide in accordance with good 

agricultural practices, exposure of 

humans to residues of these 

bacteriophage in consumed drinking 

water may occur. Although lytic 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis are not expected to reach 

surface water because the proposed use 

patterns do not include direct 

application to aquatic sites, it is possible 

that this microbial pest control agent 

could make it into ground water. 

Nonetheless, if oral exposure to lytic 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis occurs through 

consumed drinking water (e.g., due to 

surface water contamination by 

microbial pesticide spray drift or runoff 

or contact with ground water), for the 

many reasons enumerated in Unit III. 

and Unit IV.A.1., EPA concludes there 

is reasonable certainty that this type of 

drinking water exposure, or any level of 

drinking water exposure for that matter, 

will not result in harm to humans. 

B. Other Non-Occupational Exposure 

Dermal and inhalation nonoccupational exposures to lytic 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis are not expected as all 

proposed pesticide applications will 

take place in distinct agricultural 

settings. Even if dermal and inhalation 

non-occupational exposures were to 

occur inadvertently (e.g., through spray 

drift) or due to an eventual expansion of 

use sites, such exposures would not be 

of concern given the information 

presented in Unit III. and Unit IV.A. 

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 exemption, EPA 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 bacteriophage 

of Clavibacter michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis to share a common 

mechanism of toxicity with any other 

substances, and lytic bacteriophage of 

Clavibacter michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis do not appear to produce 

a toxic metabolite against the target pest. 

For the purposes of this tolerance 

action, therefore, EPA has assumed that 

lytic bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis do not have a common 

mechanism of toxicity with other 

substances. Therefore, section 

408(b)(2)(D)(v) of the FFDCA does not 

apply. 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 United 

States (U.S.) Population, Infants and 

Children 

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

that EPA shall assess the available 

information about consumption patterns 

among infants and children, special 

susceptibility of infants and children to 

pesticide chemical residues, and the 

cumulative effects on infants and 

children of the residues and other 

substances with a common mechanism 

of toxicity. In addition, FFDCA section 

408(b)(2)(C) provides that EPA shall 

apply an additional tenfold (10×) 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 

that a different margin of safety will be 

safe for infants and children. This 

additional margin of safety is commonly 

referred to as the Food Quality 

Protection Act Safety Factor. In 


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applying this provision, EPA either 

retains the default value of 10× or uses 

a different additional safety factor when 

reliable data available to EPA support 

the choice of a different factor. 

As previously discussed in Unit III. 

and Unit IV., humans, including infants 

and children, have been exposed to 

bacteriophage through food and water, 

where they are commonly found, and 

through decades of therapeutic use with 

no known or reported adverse effects. 

Based on this, as well as all the other 

reasons enumerated repeatedly in this 

unit, EPA 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 the residues of lytic 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis. Such exposure includes 

all anticipated dietary exposures and all 

other exposures for which there is 

reliable information. EPA has arrived at 

this conclusion because, considered 

collectively, the public literature 

available on bacteriophage, including 

the one at issue in this action, do not 

demonstrate toxic, pathogenic, and/or 

infective potential to mammals. Thus, 

there are no threshold effects of concern 

and, as a result, an additional margin of 

safety is not necessary. 

VII. Other Considerations 

A. Analytical Enforcement Methodology 

An analytical method is not required 

for enforcement purposes for the 

reasons stated above and because EPA 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. In this context, 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 bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis. 

C. Revisions to Requested Exemption 

In its petition, the petitioner 

requested generally that the Agency 

issue an exemption from the 

requirement of a tolerance for residues 

of bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis in or on tomato. The 

petitioner’s supporting materials 

indicated that the actual pesticide that 

would be used would be safe because 

the bacteriophage were lytic and 

produced in Clavibacter michiganensis 

subspecies michiganensis. The Agency 

believes both that these two conditions 

are necessary to make the safety finding 

and the petitioner was only requesting 

a narrow exemption; therefore, the 

Agency is modifying the tolerance 

exemption regulatory text to include 

such criteria. 

VIII. Conclusions 

EPA 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 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis. Therefore, an exemption 

from the requirement of a tolerance is 

established for residues of lytic 

bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis in or on tomato when 

applied as a bactericide in accordance 

with good agricultural practices. 

IX. References 

1. Keel C, Ucurum Z, Michaux P, Adrian M, 

Haas D. 2002. Deleterious impact of a 

virulent bacteriophage on survival and 

biocontrol activity of Pseudomonas 

fluorescens strain CHAO in natural soil. 

Molecular Plant-Microbe Interactions 

15:567–576. 

2. Liew KW, Alvarez AM. 1981. Biological 

and morphological characterization of 

Xanthomonas campestris bacteriophages. 

Phytopatholoy 71:269–273. 

3. Demuth J, Neve H, Witzel K–P. 1993. 

Direct electron microscopy study on the 

morphological diversity of bacteriophage 

populations in Lake Plussse. Applied 

and Environmental Microbiology 

59:3378–3384. 

4. Eayre CG, Bartz JA, Concelmo DE. 1995. 

Bacteriophages of Erwinia carotovora 

and Erwinia ananas isolated from 

freshwater lakes. Plant Disease 79:801– 

804. 

5. Schnabel EL, Jones AL. 2001. Isolation and 

characterization of five Erwinia 

amylovora bacteriophages and 

assessment of phage resistance in strains 

of Erwinia amylovora. Applied and 

Environmental Microbiology 67:59–64. 

6. Denis FA. 1975. Contamination of shellfish 

with strains of Pseudomonas aeruginosa 

and specific bacteriophages. Canadian 

Journal of Microbiology 21:1055–1057. 

7. Merril CR, Scholl D, Adhya SL. 2003. The 

prospect for bacteriophage therapy in 

Western medicine. Nature 2:489–497. 

8. Rohwer F. 2003. Global phage diversity. 

Cell 113:1–2. 

9. Stocker BAD. 1955. Bacteriophage and 

bacterial classification. Journal of 

General Microbiology 12:375–381. 

10. Duckworth DH, Gulig PA. 2002. 

Bacteriophage: potential treatment for 

bacterial infections. Biodrugs 16:57–62. 

11. Summers WC. 2001. Bacteriophage 

therapy. Annual Review of Microbiology 

55:437–451. 

12. Lorch A. 1999. Bacteriophage: an 

alternative to antibiotics? Biotechnology 

and Development Monitor 39:14–17. 

13. Petricciani JC, Hsu TC, Stock AD, Turner 

JH, Wenger SL, Elisberg BL. 1978. 

Bacteriophages, vaccines, and people: an 

assessment of risk. Proceedings of the 

Society for Experimental Biology and 

Medicine. 58:378–382. 

14. Ackermann H–W. 1997. Bacteriophage 

ecology. Pp. 335–339 in: ‘‘Progress in 

Microbial Ecology (Proceedings of 

Seventh International Symposium on 

Microbial Ecology)’’. Martins MT, Sato 

MIZ, Tiedje JM, Hagler LCN, Do ̈bereiner 

J, Sanchez PS, eds. Brazilian Society for 

Microbiology. 

15. Kennedy JE Jr, Wei CI, Oblinger JL. 1986. 

Methodology for enumeration of 

coliphages in foods. Applied and 

Environmental Microbiology 51:956–962. 

16. Kennedy JE Jr, Oblinger JL, Bitton G. 

1984. Recovery of coliphages from 

chicken, pork sausage and delicatessen 

meats. Journal of Food Protection 

47:623–626. 

17. DePaola A, Motes ML, Chan AM, Suttle 

CA. 1998. Phages infecting Vibrio 

vulnificus are abundant and diverse in 

oysters (Crassostrea virginica) collected 

from the Gulf of Mexico. Applied and 

Environmental Microbiology 64:346–351. 

18. Quiberoni A, Tremblay D, Ackermann H– 

W, Moineau S, Reinheimer JA. 2006. 

Diversity of Streptococcus thermophilus 

phages in a large-production cheese 

factory in Argentina. Journal of Dairy 

Science 89:3791–3799. 

19. Guillaumes J, Houdeau G, Germain R, 

Olivier JM. 1988. Improvement of the 

biocontrol of Pseudomonas tolaasii using 

bacteriophages associated with an 

antagonistic bacterium. Bulletin OEPP 

18:77–82. 

20. Radetsky P. 1996. The good virus. 

Discover 17:50–58. 

21. Chanishvili N, Chanishvili T, Tediashvili 

M, Barrow PA. 2001. Phages and their 


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66192 Federal Register / Vol. 76, No. 207 / Wednesday, October 26, 2011 / Rules and Regulations 

application against drug-resistant 

bacteria. Journal of Chemical Technology 

and Biotechnology 76:689–699. 

22. U.S. EPA. 2011. Bacteriophage of 

Clavibacter michiganensis subsp. 

michiganensis—AgriPhage CMM. 

Memorandum from J.V. Gagliardi, Ph.D. 

to A. Gross dated June 30, 2011. 

23. U.S. EPA. 2011. Bacteriophage of 

Clavibacter michiganensis subspecies 

michiganensis Biopesticides Registration 

Action Document dated August 25, 2011 

(available as ‘‘Supporting & Related 

Material’’ with docket ID number EPA– 

HQ–OPP2009–0539 at http://www.

regulations.gov). 

24. Atterbury RJ, Connerton PL, Dodd CER, 

Rees CED, Connerton IF. 2003. Isolation 

and characterization of Campylobacter 

bacteriophages from retail poultry. 

Applied and Environmental 

Microbiology 69:4511–4518. 

25. Gautier M, Rouault A, Sommer P, 

Briandet R. 1995. Occurrence of 

Propionibacterium freudenreichii 

bacteriophages in swiss cheese. Applied 

and Environmental Microbiology 

61:2572–2576. 

26. Greer GG. 2005. Bacteriophage control of 

foodborne bacteria. Journal of Food 

Protection 68:1102–1111. 

27. Whitman PA, Marshall RT. 1971. 

Isolation of psychrophilic 

bacteriophagehost systems from 

refrigerated food products. Applied 

Microbiology 22:220–223. 

28. El-Abagy MM, Dutka BJ, Kamel M. 1988. 

Incidence of coliphage in potable water 

supplies. Applied and Environmental 

Microbiology 54:1632–1633. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

exemption under section 408(d) of 

FFDCA in response to a petition 

submitted to EPA. 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 exemption 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. 

As a result, this action does not 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, 

EPA 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, EPA 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 

EPA 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). 

XI. 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: September 30, 2011. 

Steven Bradbury, 

Director, 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 180.1307 is added to 

subpart D to read as follows: 

§ 180.1307 Bacteriophage of Clavibacter 

michiganensis subspecies michiganensis; 

exemption from the requirement of a 

tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of lytic bacteriophage of Clavibacter 

michiganensis subspecies 

michiganensis produced in Clavibacter 

michiganensis subspecies 

michiganensis in or on tomato when 

applied as a bactericide in accordance 

with good agricultural practices. 

[FR Doc. 2011–27042 Filed 10–25–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF COMMERCE 

National Oceanic and Atmospheric 

Administration 

50 CFR Part 648 

[Docket No. 101119575–1554–02] 

RIN 0648–BA46 

Fisheries of the Northeastern United 

States; Monkfish; Framework 

Adjustment 7 

AGENCY: National Marine Fisheries 

Service (NMFS), National Oceanic and 

Atmospheric Administration (NOAA), 

Commerce. 

ACTION: Final rule. 

SUMMARY: This final rule implements 

measures that were approved in 

Framework Adjustment 7 to the 

Monkfish Fishery Management Plan. 

The New England Fishery Management 

Council and Mid-Atlantic Fishery 

Management Council developed 

Framework Adjustment 7 to adjust the 

annual catch target for the Northern 

Fishery Management Area to be 

consistent with the most recent 


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