Federal Register / Vol. 77, No. 4 / Friday, January 6, 2012 / Rules and Regulations 745 

PART 530—EXTRALABEL DRUG USE 

IN ANIMALS 

■ 1. The authority citation for 21 CFR 

part 530 continues to read as follows: 

Authority: 15 U.S.C. 1453, 1454, 1455; 21 

U.S.C. 321, 331, 351, 352, 353, 355, 357, 

360b, 371, 379e. 

■ 2. In § 530.41, add paragraph (a)(13) to 

read as follows: 

§ 530.41 Drugs prohibited for extralabel 

use in animals. 

(a) * * * 

(13) Cephalosporins (not including 

cephapirin) in cattle, swine, chickens, 

or turkeys: 

(i) For disease prevention purposes; 

(ii) At unapproved doses, frequencies, 

durations, or routes of administration; 

or 

(iii) If the drug is not approved for 

that species and production class. 

* * * * * 

Dated: November 23, 2011. 

Bernadette Dunham, 

Director, Center for Veterinary Medicine. 

[FR Doc. 2012–35 Filed 1–4–12; 11:15 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[DOD–2010–OS–0043; RIN 0790–AI62] 

32 CFR Part 222 

DoD Mandatory Declassification 

Review (MDR) Program; Correction 

AGENCY: Department of Defense. 

ACTION: Final rule; correction. 

SUMMARY: On December 27, 2011 (76 FR 

80744–80747), Department of Defense 

published a final rule titled DoD 

Mandatory Declassification Review 

(MDR) Program, which assigns 

responsibilities and provides 

procedures for members of the public to 

request a declassification review of 

information classified under the 

provisions of Executive Order 13526, or 

predecessor orders. This rule corrects a 

paragraph identification error in the 

regulations. 

DATES: This correction is effective 

January 26, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Patricia Toppings, (571) 372–0485. 

SUPPLEMENTARY INFORMATION: On 

December 27, 2011, Department of 

Defense published a final rule titled 

DoD Mandatory Declassification Review 

(MDR) Program. Subsequent to the 

publication of that final rule, 

Department of Defense discovered that 

paragraph § 222.5(f) in the third column 

of page 80746 should have read 

§ 222.5(j). 

Correction 

In the final rule (FR Doc. 2011–33104) 

published on December 27, 2011 (76 FR 

80744–80747), make the following 

correction: 

§ 222.5 [Corrected] 

On page 80746, in § 222.5, in the third 

column, in the first line of the third 

paragraph, ‘‘(f) MDR Appeals.’’ should 

read ‘‘(j) MDR Appeals.’’. 

Dated: December 30, 2011. 

Aaron Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2011–33857 Filed 1–5–12; 8:45 am] 

BILLING CODE 5001–06–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2011–0547; FRL–9480–1] 

Revisions to the California State 

Implementation Plan, San Joaquin 

Valley Unified Air Pollution Control 

District (SJVUAPCD) 

Correction 

In rule document 2011–33660 

appearing on pages 214–217 in the issue 

of Wednesday, January 4, 2012, make 

the following corrections: 

(1) On page 214, in the second 

column, in the DATES section, in the 

second line, ‘‘February 3, 2011’’ should 

read ‘‘February 3, 2012’’. 

(2) On page 217, in the first column, 

in the last paragraph, in the fifth line, 

‘‘March 7, 2011’’ should read ‘‘March 5, 

2012’’. 

[FR Doc. C1–2011–33660 Filed 1–5–12; 8:45 am] 

BILLING CODE 1505–01–D 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2010–0944; FRL–9330–4] 

Bacillus Amyloliquefaciens Strain 

D747; 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 the Bacillus 

amyloliquefaciens strain D747 (formerly 

known as Bacillus subtilis variant 

amyloliquefaciens strain D747) in or on 

all food commodities when used in 

accordance with good agricultural 

practices. Certis USA LLC 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 Bacillus 

amyloliquefaciens strain D747 (formerly 

known as Bacillus subtilis variant 

amyloliquefaciens strain D747). 

DATES: This regulation is effective 

January 6, 2012. Objections and requests 

for hearings must be received on or 

before March 6, 2012, 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–2010–0944. 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 the disclosure 

of which is restricted by statute. Certain 

other material, such as copyrighted 

material, is not made available via 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: 

Susanne Cerrelli, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 308–8077; email address: 

cerrelli.susanne@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 


pmangrum on DSK3VPTVN1PROD with RULES
746 Federal Register / Vol. 77, No. 4 / Friday, January 6, 2012 / Rules and Regulations 

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 readers 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–2010–0944 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 March 6, 2012. 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–2010–0944, 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 Avenue 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 February 4, 

2011 (76 FR 6465) (FRL–8858–7), 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 0F7760) 

by Certis USA LLC, 9145 Guilford Road, 

Suite 175, Columbia, MD 21046. The 

petition requested that 40 CFR part 180 

be amended by establishing an 

exemption from the requirement of a 

tolerance for residues of Bacillus subtilis 

variant amyloliquefaciens strain D747 

(now recognized as Bacillus 

amyloliquefaciens strain D747). This 

notice referenced a summary of the 

petition prepared by the petitioner, 

Certis USA LLC, which is available in 

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

Comments were received on the notice 

of filing. EPA’s response to these 

comments is discussed in Unit VII.C. 

Based upon review of the data 

supporting the petition, EPA has 

modified the nomenclature of the active 

ingredient, which was recently 

reclassified as Bacillus 

amyloliquefaciens strain D747 (Refs. 1, 

2, and 3). The reason for this change is 

explained in Unit III. A. 

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 

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. Overview of Bacillus 

Amyloliquefaciens Strain D747 

Bacillus amyloliquefaciens strain 

D747 was previously identified as 

Bacillus subtilis variant 

amyloliquefaciens strain D747 in the 

petition submitted to exempt the 

bacterium from the requirement of a 

tolerance when used as a microbial 

pesticide in or on all food commodities. 

Bacillus subtilis and Bacillus 

amyloliquefaciens were considered 

subtypes or variants of the same species. 

Now, however, Bacillus 

amyloliquefaciens is taxonomically 

designated as a separate species. The 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 77, No. 4 / Friday, January 6, 2012 / Rules and Regulations 747 

taxonomic designation used in this final 

rule is correct. 

Certis USA, LLC, has proposed to 

register Bacillus amyloliquefaciens 

strain D747 for control of fungi and 

bacteria in greenhouses, nurseries, and 

shadehouses, and on outdoor 

agricultural crops, ornamentals, and 

turfgrass. Bacillus amyloliquefaciens 

strain D747 is the active ingredient in 

the two end-use products (EP) CX–9030 

(EPA File Symbol 70051–RNI) and CX– 

9032 (EPA File Symbol 70051–RNT). 

B. Microbial Pesticide Toxicology Data 

Requirements 

All mammalian toxicology data 

requirements supporting the petition to 

exempt from the requirement of a 

tolerance residues of Bacillus 

amyloliquefaciens strain D747 in or on 

all food commodities have been fulfilled 

with acceptable studies. The acute oral, 

injection and pulmonary toxicity/ 

pathogenicity studies show that Bacillus 

amyloliquefaciens strain D747 is not 

toxic, infective, or pathogenic at the 

doses tested. 

1. Acute oral toxicity/pathogenicity 

(Office of Chemical Safety and Pollution 

Prevention (OCSPP) Guideline 885.3050; 

Master Record Identification Number 

(MRID) No. 481657–04). Bacillus 

amyloliquefaciens strain D747 was 

administered once orally to 14 rats of 

both sexes (5-weeks old) at a single 

dosage of 108 colony-forming units 

(CFU) per animal. No deaths occurred, 

and no abnormalities (clinical signs, 

body weight) were observed, during the 

study or at necropsy. The test microbe 

was detected at 103¥105 CFU/g in feces 

1 day after administration of the test 

material, but was not detected on day 

14. The examination for internal 

persistence did not detect the test 

microbe in any organs or tissues, such 

as the kidney, brain, liver, lung, spleen, 

stomach, small intestine (duodenum), 

large intestine (cecum), mesenteric 

lymph nodes, or blood, throughout the 

experimental period. Fecal clearance 

occurred by day 14, and no viable 

organisms were recovered from blood or 

other organs or tissues. The results of 

this acceptable study demonstrated that 

Bacillus amyloliquefaciens strain D747 

was not infective, pathogenic, or toxic to 

rats when orally dosed with 1.0 × 108

CFU/animal. 

2. Acute pulmonary toxicity/ 

pathogenicity (OCSPP Guideline 

885.3150; MRID No.481657–06). Twenty 

male and female rats were given a single 

dose of 1.0 × 107 spores Bacillus 

amyloliquefaciens strain D747 via a 

tracheal route of administration. No 

mortalities or clinical effects were 

observed in the test animals throughout 

the duration of the study. Clearance of 

the test material was steady, although 

residual viable cells remained in the 

lungs and trachea at the end of the 60 

day study. This result was typical of 

spore forming bacteria because bacterial 

spores take longer to be cleared by 

healthy immune systems than the 

vegetative form of bacteria. This 

acceptable study demonstrated that 

Bacillus amyloliquefaciens strain D747 

was not toxic and/or pathogenic to rats 

when dosed intratracheally at 1.0 × 107

(CFU)/animal. 

3. Acute injection toxicity/ 

pathogenicity (intravenous)—rat 

(OCSPP Guideline 885.3200; MRID No. 

481657–05). An acceptable acute 

injection toxicity and pathogenicity 

study demonstrated that Bacillus 

amyloliquefaciens strain D747 was not 

toxic, infective, or pathogenic to rats 

that were injected with approximately 

1.0 × 107 CFU/animal. 

4. Bacillus amyloliquefaciens strain 

D747 was administered intravenously to 

groups of 17 male and female rats at a 

dose of 1.0 × 107 spores per animal. 

There were no mortalities, no clinical 

effects from intravenous administration, 

and steady weight gain of treated rats 

throughout the study duration. 

Clearance was steady though residual 

viable cells remained in the liver and 

spleen at day 60 on study termination, 

typical of spore forming bacteria 

administered to rats. There was no 

evidence of an increase in viable counts 

over time that would be indicative of a 

chronic infection. Since a pattern of 

clearance was shown, it is assumed that 

the remaining viable cells were spores 

that take longer to be cleared by healthy 

immune systems. 

5. Acute dermal toxicity (OCSPP 

Guideline 870.1200; MRID No. 481657– 

08). An acceptable 14-day acute dermal 

toxicity study demonstrated that that 

the CX–9030 product, which contains 

Bacillus amyloliquefaciens strain D747, 

was not toxic in rats dosed at 5,050 mg/ 

kg. [median lethal dose, (LD50) > 5,050 

mg/kg. EPA Toxicity Category IV.] 

6. Acute dermal irritation (OCSPP 

Guideline 870.2500; MRID No.: 481655– 

11). An acceptable dermal irritation 

study demonstrated that no evidence of 

irritation occurred from dermal 

administration of 500 mg of CX–9030 to 

rabbits during the 4-hour exposure and 

the 72-hour observation period. The 

dermal irritation score for Bacillus 

amyloliquefaciens strain D747 CX–9030 

was 0.00 (EPA Toxicity Category IV). 

7. Acute dermal irritation (OCSPP 

Guideline 870.2500; MRID No.: 481655– 

06). A second acceptable dermal 

irritation study also demonstrated that 

CX–9032 product containing Bacillus 

amyloliquefaciens strain D747 was nonirritating. No evidence of irritation was 

observed for 72 hours following the 4 

hour dermal administration of 0.5 mL 

undiluted CX–9032 to the shaved skin 

rabbits. The dermal irritation score for 

Bacillus amyloliquefaciens strain D747 

CX–9032 was 0.00 (EPA Toxicity 

Category IV). 

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 

Dietary exposure to this microbial 

pesticide may occur, but the complete 

absence of any acute oral toxicity, 

infectivity, and/or pathogenicity effects, 

as discussed in Unit III.B., supports the 

conclusion that this active ingredient is 

not toxic at high exposure levels, and, 

therefore, establishment of a tolerance 

exemption for residues of Bacillus 

amyloliquefaciens strain D747 is 

appropriate. 

1. Food. Based on the results from the 

toxicity studies presented in Unit III.B., 

no toxicity, infectivity, pathogenicity or 

other adverse effects from dietary 

exposure to Bacillus amyloliquefaciens 

strain D747 from the proposed 

pesticidal uses of Bacillus 

amyloliquefaciens strain D747 are 

expected. Bacillus species, including 

Bacillus amyloliquefaciens, are 

commonly found in agricultural 

settings, and occur naturally on fresh 

produce with no known adverse effects. 

The Manual of Clinical Microbiology 

(9th edition) mentions that dried food, 

such as spices, milk powder, and grains, 

often contains large amounts of Bacillus 

spores (Ref. 3). Bacillus 

amyloliquefaciens is not known to 

produce mammalian toxins, and no 

foodborne illnesses associated with 

Bacillus amyloliquefaciens have been 

reported. 

2. Drinking water exposure. Bacillus 

amyloliquefaciens is naturally present 

in soils (Ref. 2); therefore, Bacillus 

amyloliquefaciens may occur in surface 

water and possibly groundwater. 

According to the World Health 

Organization, Bacillus species are often 

detected in drinking water even after 

going through acceptable water 

treatment processes, largely because the 

spores are resistant to these disinfection 


pmangrum on DSK3VPTVN1PROD with RULES
748 Federal Register / Vol. 77, No. 4 / Friday, January 6, 2012 / Rules and Regulations 

processes (Ref. 4). Should this microbial 

pesticide be present, no adverse effects 

are expected from exposure to Bacillus 

amyloliquefaciens through drinking 

water, based on the results of toxicity 

studies described in Unit III.B. 

B. Other Non-Occupational Exposure 

The use sites for these products 

include residential gardens, as well as 

agricultural sites. Based on the results of 

the acute toxicity tests described in Unit 

III.B., the Agency believes that the 

potential aggregate, non-occupational 

risks from exposure to Bacillus 

amyloliquefaciens strain D747, when 

used as a microbial pesticide, are 

negligible. 

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 the microbial 

active ingredient to share a common 

mechanism of toxicity with any other 

substances, and Bacillus 

amyloliquefaciens strain D747 does not 

appear to produce any toxic metabolites. 

For the purposes of this tolerance 

action, therefore, EPA has assumed that 

Bacillus amyloliquefaciens strain D747 

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. 

VI. Determination of Safety for 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 (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 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 applying this provision, EPA 

either retains the default value of 10X or 

uses a different safety factor when 

reliable data available to EPA support 

the choice of a different factor. 

Based on the acute toxicity and 

pathogenicity data/information 

summarized in Unit III, 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 Bacillus amyloliquefaciens 

strain D747. 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 data and other 

information (e.g., lack of toxicity noted 

for oral, dermal, and inhalation routes of 

exposure) available on Bacillus 

amyloliquefaciens strain D747 do not 

demonstrate toxic, pathogenic, and/or 

infective potential to sensitive 

populations from exposure to this 

microbial pest control agent. There are 

no threshold effects of concern and, as 

a result, the provision requiring an 

additional margin of safety is not 

necessary. 

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 Bacillus amyloliquefaciens strain 

D747. 

C. Response to Comments 

Two comments were submitted. An 

anonymous comment was submitted 

expressing opposition to granting an 

exemption from the requirement of a 

tolerance to the applicant. (EPA–HQ– 

OPP–2010–0012–0019). The commenter 

submitted a number of comments in the 

same communication that suggested that 

this and other active ingredients should 

not be granted exemptions. The 

commenter expressed concern about 

toxic chemical residues on produce and 

on earth, and suggested that the ‘‘Dept. 

of Health’’ should analyze the health 

effects of toxic chemicals. In the United 

States, EPA is responsible for regulating 

pesticides under FIFRA and the FQPA, 

and has analyzed the toxicity of this 

microbial active ingredient. As 

described in Unit III.B., the results of 

the acute oral, injection and pulmonary 

toxicity/pathogenicity studies 

demonstrated that Bacillus 

amyloliquefaciens strain D747 is not 

toxic, infective or pathogenic at the 

doses tested. 

Another commenter also expressed 

opposition to granting a tolerance or an 

exemption from the requirement of a 

tolerance for this and other chemicals 

that were listed in the same registration 

notice. (EPA–HQ–OPP–2010–0905– 

0003). This commenter stated that the 

food supply must be rigorously tested, 

that studies must be subjected to 

independent peer review, and that only 

long term studies can provide data on 

the health impact to these chemicals. 

Consistent with section 408(b)(2)(D) of 

FFDCA, the testing data that were 

provided and evaluated by EPA for 

Bacillus amyloliquefaciens strain D747, 

as described in Unit III.B., support 

granting this exemption. 

VIII. Conclusions 

Therefore, an exemption is 

established for residues of Bacillus 

amyloliquefaciens strain D747. 

IX. References 

1. Priest, F.G., M. Goodfellow, L.A. Shute, 

and R.C.W. Berkeley. 1987. Bacillus 

amyloliquefaciens sp. nov., nom. rev. 

International Journal of Systematic 

Bacteriology, 37: 69–71. 

2. Logan, N.A., and P. de Vos. 2009. Genus 

I. Bacillus, Pp. 21–128 In: P. de Vos, 

G.M. Garrity, D. Jones, N.R. Krieg, W. 

Ludwig, F.A. Rainey, K.H. Schleifer, and 

W. Whitman (Eds.) Bergey’s Manual of 

Systematic Bacteriology, Volume 3, 2nd 

Ed. Springer, New York. 


pmangrum on DSK3VPTVN1PROD with RULES
Federal Register / Vol. 77, No. 4 / Friday, January 6, 2012 / Rules and Regulations 749 

3. Murray, P.R, et al., Manual of Clinical 

Microbiology. Washington, DC: ASM 

Press; 9th edition, 2007. 

4. World Health Organization, Guidelines for 

Drinking-water Quality. (2011) 4th Ed. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes an 

exemption from the requirement of 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). 

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: December 15, 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 180.308 is added to subpart 

D to read as follows: 

§ 180.308 Bacillus amyloliquefaciens 

strain D747; exemption from the 

requirement of a tolerance. 

An exemption from the requirement 

of a tolerance is established for residues 

of the microbial pesticide, Bacillus 

amyloliquefaciens strain D747 in or on 

all food commodities when used in 

accordance with good agricultural 

practices. 

[FR Doc. 2011–33846 Filed 1–5–12; 8:45 am] 

BILLING CODE 6560–50–P 

GENERAL SERVICES 

ADMINISTRATION 

48 CFR Parts 501, 539, and 552 

[GSAR Amendment 2011–03; GSAR Case 

2011–G503; (Change 52); Docket 2011– 

0012, Sequence 1] 

RIN 3090–AJ15 

General Services Administration 

Acquisition Regulation; 

Implementation of Information 

Technology Security Provision 

AGENCY: Office of Acquisition Policy, 

General Services Administration (GSA). 

ACTION: Final rule. 

SUMMARY: GSA has adopted as final, 

with changes, an interim rule amending 

the General Services Administration 

Acquisition Regulation (GSAR) to 

implement policy and guidelines to 

strengthen the security requirements for 

contracts and orders that include 

information technology (IT) supplies, 

services and systems. 

DATES: Effective Date: January 6, 2012. 

Applicability Date: This amendment 

applies to contracts and orders awarded 

after January 6, 2012 that include 

information technology (IT) supplies, 

services and systems with security 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Ms. Deborah Lague, Procurement 

Analyst, at (202) 694–8149, for 

clarification of content. For information 

pertaining to status or publication 

schedules, contact the Regulatory 

Secretariat at (202) 501–4755. Please 

cite GSAR Amendment 2011–03, GSAR 

Case 2011–G503. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The GSA Office of the Inspector 

General (OIG) conducted an audit of 

GSA’s information and information 

technology systems to verify that GSA 

has met the requirements of the Federal 

Information Security Management Act 

of 2002 (FISMA). The OIG made a 

recommendation to strengthen the 

security requirements in contracts and 

orders for information technology 

supplies, services and systems. GSA 

agreed with the OIG recommendation 

and published an interim rule in the 

Federal Register at 76 FR 34886 on 

June 15, 2011, with a request for 

comments. As a result, this final rule 

implements the interim rule with only 

minor changes. 

II. GSAR Changes 

The changes to GSAR Parts 539 and 

552 will remain as implemented by the 

interim rule. 


pmangrum on DSK3VPTVN1PROD with RULES