17600 Federal Register / Vol. 78, No. 56 / Friday, March 22, 2013 / Rules and Regulations 

‘‘In further response to commenters’ 

questions about whether an institution 

could provide incentive compensation 

to employees in college diversity offices 

who recruit minority students, we note 

that the HEA prohibits all direct or 

indirect payments of incentive 

compensation to personnel or staff 

engaged in student recruitment and 

does not distinguish between incentives 

for personnel or staff recruitment 

actions that could have certain effects, 

e.g., recruitment of a well-qualified or 

diverse student body. The prohibition 

thus includes a prohibition on paying 

incentive compensation for efforts to 

promote diversity at an institution. The 

Department’s objective in removing all 

of the safe harbors is to separate the 

meritorious performance of all 

employees from an enrollment-based 

compensation system, consistent with 

the statute’s language, regardless of 

what the purpose of the enrollment 

might be. 

We also wish to reiterate that the 

incentive compensation prohibition is 

designed to protect all students from 

receiving undue pressure to enroll or to 

graduate. The statute and the 

implementing regulations ban all 

compensation to persons and entities 

that directly or indirectly provide an 

incentive to encourage enrollment. The 

incentive compensation ban is designed, 

among other things, to keep students of 

all races and backgrounds from being 

urged or cajoled into enrolling in a 

program that will not best meet their 

needs. Minority and low income 

students are often the targeted audience 

of recruitment abuses, and our 

regulatory changes are intended to end 

that abuse. It is our expectation and 

objective that enrollment of students, 

including minority students, against 

their best educational interests would be 

reduced with the elimination of 

improper incentive compensation. 

In point of fact, there never was a safe 

harbor addressing minority recruitment; 

neither the prior regulations nor these 

regulations provided a change in this 

area. Institutions are encouraged to 

continue to enroll all students in 

programs of instruction that are 

designed to promote their academic 

achievement and occupational success. 

We believe our regulations encourage 

and support this outcome.’’ 

List of Subjects 

34 CFR Part 600 

Colleges and universities, Foreign 

relations, Grant programs—education, 

Loan programs—education, Reporting 

and recordkeeping requirements, 

Student aid, Vocational education. 

34 CFR Part 602 

Colleges and universities, Reporting 

and recordkeeping requirements. 

34 CFR Part 603 

Colleges and universities, Vocational 

education. 

34 CFR Part 668 

Administrative practice and 

procedure, Aliens, Colleges and 

universities, Consumer protection, 

Grant programs—education, Loan 

programs—education, Reporting and 

recordkeeping requirements, Selective 

Service System, Student aid, Vocational 

education. 

34 CFR Part 682 

Administrative practice and 

procedure, Colleges and universities, 

Loan programs—education, Reporting 

and recordkeeping requirements, 

Student aid, Vocational education. 

34 CFR Part 685 

Administrative practice and 

procedure, Colleges and universities, 

Loan programs—education, Reporting 

and recordkeeping requirements, 

Student aid, Vocational education. 

34 CFR Part 686 

Administrative practice and 

procedure, Colleges and universities, 

Education, Elementary and secondary 

education, Grant programs—education, 

Reporting and recordkeeping 

requirements, Student aid. 

34 CFR Part 690 

Colleges and universities, Education 

of disadvantaged, Grant programs— 

education, Reporting and recordkeeping 

requirements, Student aid. 

34 CFR Part 691 

Colleges and universities, Elementary 

and secondary education, Grant 

programs—education, Student aid. 

Dated: March 18, 2013. 

Arne Duncan, 

Secretary of Education. 

[FR Doc. 2013–06656 Filed 3–21–13; 8:45 am] 

BILLING CODE 4000–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2011–1026; FRL–9380–6] 

Banda de Lupinus albus doce (BLAD); 

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 banda de 

Lupinus albus doce (BLAD), a naturally 

occurring polypeptide from the 

catabolism of a seed storage protein (bconglutin) of sweet lupines (Lupinus 

albus), in or on all food commodities 

when applied as a fungicide and used 

in accordance with label directions and 

good agricultural practices. On behalf of 

Consumo Em Verde S.A., Bert Volger of 

Ceres International 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 BLAD under the FFDCA. 

DATES: This regulation is effective 

March 22, 2013. Objections and requests 

for hearings must be received on or 

before May 21, 2013, 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: The docket for this action, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2011–1026, is 

available at http://www.regulations.gov 

or at the Office of Pesticide Programs 

Regulatory Public Docket (OPP Docket) 

in the Environmental Protection Agency 

Docket Center (EPA/DC), EPA West 

Bldg., Rm. 3334, 1301 Constitution Ave. 

NW., Washington, DC 20460–0001. The 

Public Reading Room is open from 8:30 

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

Friday, excluding legal holidays. The 

telephone number for the Public 

Reading Room is (202) 566–1744, and 

the telephone number for the OPP 

Docket is (703) 305–5805. Please review 

the visitor instructions and additional 

information about the docket available 

at http://www.epa.gov/dockets. 

FOR FURTHER INFORMATION CONTACT: 

Menyon Adams, Biopesticides and 

Pollution Prevention Division (7511P), 

Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; telephone number: 

(703) 347–8496; email address: 

adams.menyon@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. The following 


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list of North American Industrial 

Classification System (NAICS) codes is 

not intended to be exhaustive, but rather 

provides a guide to help readers 

determine whether this document 

applies to them. Potentially affected 

entities may include: 

• Crop production (NAICS code 111). 

• Animal production (NAICS code 

112). 

• Food manufacturing (NAICS code 

311). 

• Pesticide manufacturing (NAICS 

code 32532). 

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 OCSPP 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–2011–1026 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 May 21, 2013. 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 (excluding 

any Confidential Business Information 

(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 the non-CBI copy of your 

objection or hearing request, identified 

by docket ID number EPA–HQ–OPP– 

2011–1026, by one of the following 

methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

Do not submit electronically any 

information you consider to be CBI or 

other information whose disclosure is 

restricted by statute. 

• Mail: OPP Docket, Environmental 

Protection Agency Docket Center (EPA/ 

DC), (28221T), 1200 Pennsylvania Ave. 

NW., Washington, DC 20460–0001. 

• Hand Delivery: To make special 

arrangements for hand delivery or 

delivery of boxed information, please 

follow the instructions at http:// 

www.epa.gov/dockets/contacts.htm. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

http://www.epa.gov/dockets. 

II. Background and Statutory Findings 

In the Federal Register of March 14, 

2012 (77 FR 15012) (FRL–9335–9), EPA 

issued a document pursuant to FFDCA 

section 408(d)(3), 21 U.S.C. 346a(d)(3), 

announcing the filing of a pesticide 

tolerance petition (PP 1F7917) by Bert 

Volger of Ceres International LLC, 1087 

Heartsease Drive, West Chester, PA 

19382, on behalf of Consumo Em Verde 

S.A, Biotecnologia De Plantas, Parque 

Technologico de Cantanhede, Nucleo 

04, Lote 2, 3060–197 Cantanhede, 

Portugal. The petition requested that 40 

CFR part 180 be amended by 

establishing an exemption from the 

requirement of a tolerance for residues 

of BLAD. This notice referenced a 

summary of the petition prepared by the 

petitioner, Bert Volger of Ceres 

International LLC (on behalf of 

Consumo Em Verde S.A.), 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 

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

establishing or maintaining in effect an 

exemption from the requirement of a 

tolerance, EPA must take into account 

the factors set forth in FFDCA section 

408(b)(2)(C), 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 exposure to the pesticide 

chemical residue * * *’’ Additionally, 

FFDCA section 408(b)(2)(D) 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 FFDCA section 

408(b)(2)(D), EPA 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 also considered 

available information concerning the 

variability of the sensitivities of major 

identifiable subgroups of consumers, 

including infants and children. 

BLAD, used as a fungicide, is a 

naturally occurring 20 kilo Dalton (kDa) 

polypeptide of b-conglutin formed 

during days 4 to 12 of the germination 

process of the flowering plant, sweet 

lupines (Lupinus albus). It is also 

characterized as a fragment of the amino 

acid sequence of b-conglutin and the 

main storage protein in sweet lupines 

with a long history of safe use in human 

and livestock consumption without any 

adverse effects. (Ref. 1). 

Lupines albus, commonly known as 

white or sweet lupine or lupin, is a 

member of the genus Lupinus in the 

family of Fabaceae. Lupines albus 

contains the full range of essential 

amino acids and for hundreds of years 

has been widely cultivated worldwide; 

for example, in the Mediterranean Basin 

and also Egypt, Sudan, Ethiopia, Syria, 

Central and Western Europe, the United 

States and South America, Tropical and 

Southern Africa, Russia and the 

Ukraine. (Ref. 1). 

BLAD is directly extracted from the 

flowering plant, sweet lupines. It has a 

dark brown color with a sweet odor and 

is 60% biodegradable within 14 days 

after application. (Ref. 1). Data 

submitted and reviewed by the Agency 

demonstrate that BLAD has a nontoxic 

mode of action in that it binds to chitin, 

a major component of the fungal cell 

wall, thereby inhibiting any fungal 


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growth. (Ref. 1). More specifically, 

BLAD degrades chitin by catalyzing and 

successfully removing the N-acetyl-Dglucosamine terminal monomers, 

resulting in the destruction of the fungal 

cells. (Ref. 1). 

All of the data requirements to 

support a tolerance exemption were 

fulfilled by the applicant. EPA 

concluded that the data are acceptable 

and no additional data are required. No 

acute, subchronic, or chronic toxicity 

endpoints were identified in guideline 

studies or in data obtained from open 

technical literature. Moreover, BLAD is 

not a mutagen, and is not a 

developmental toxicant. There are no 

known effects on endocrine systems via 

oral, dermal, or inhalation exposure. 

(Ref. 1). 

Summaries of the toxicological data 

submitted by the petitioner in support 

of this tolerance exemption follows: 

Acute toxicity. Acute toxicity studies 

confirm BLAD’s low toxicity profile for 

all routes of exposure. For more 

information about the Toxicity 

Categories mentioned in the summaries 

directly below refer to 40 CFR 156.62. 

1. The acute oral median lethal dose 

(LD50) in rats was greater than 5,000 

milligrams per kilogram of bodyweight 

(mg/kg/bwt). There were no observed 

toxicological effects on the test subjects 

in the acute oral study submitted by the 

petitioner. BLAD is classified as 

Toxicity Category IV for acute oral 

toxicity. (Harmonized Guideline 

870.1100; Master Record Identification 

(MRID) No. 48587904). (Ref. 1). 

2. The acute dermal LD50 in rats was 

greater than 2,000 mg/kg/bwt. BLAD is 

classified as Toxicity Category III for 

acute dermal toxicity. (Harmonized 

Guideline 870.1200; MRID No. 

48587905). (Ref. 1). 

3. The acute inhalation median lethal 

concentration (LC50) was greater than 

5.34 milligrams per liter (mg/L) in rats 

and showed no significant inhalation 

toxicity. BLAD is classified as Toxicity 

Category IV for acute inhalation toxicity. 

(Harmonized Guideline 870.1300; MRID 

No. 48587906). (Ref. 1). 

4. A primary eye irritation study on 

rabbits indicates that BLAD is mildly 

irritating to the eye. BLAD is classified 

as Toxicity Category III for primary eye 

irritation. (Harmonized Guideline 

870.2400; MRID No. 48587907). (Ref. 1). 

5. A skin irritation study on rabbits 

indicates that BLAD is mild to slightly 

irritating to the skin. BLAD is classified 

as Toxicity Category IV for primary 

dermal irritation. (Harmonized 

Guideline 870.2500; MRID No. 

48587908). (Ref. 1). 

6. Data indicate that BLAD is not a 

contact dermal sensitizer. (Harmonized 

Guideline 870.2600; MRID No. 

48587909). (Ref. 1). 

Scientific rationale and public 

literature were provided to fulfill the 

following data requirements: 90-Day 

Oral (Harmonized Guideline 870.3100), 

90-Day Dermal (Harmonized Guideline 

870.3250), 90-Day Inhalation 

(Harmonized Guideline 870.3465), 

Prenatal Development (Harmonized 

Guideline 870.3700), Bacterial Reverse 

Mutation Test (Harmonized Guideline 

870.5100), In vitro Mammalian 

Chromosome Aberration (Harmonized 

Guideline 870.5375). (Ref. 1). 

According to the acceptable scientific 

information submitted in lieu of a study 

in satisfying the data requirements 

provided to EPA (MRID No’s. 

485879109–48587914), BLAD has the 

following properties and characteristics: 

i. BLAD is used in human and animal 

nutrition as a food and feed item; and 

ii. BLAD has a nontoxic mode of 

action against fungal pests and 60% is 

biodegradable within 14 days in the 

environment, thereby minimizing any 

potential for toxic risk, such that there 

is no concern for potential exposure. 

(Ref. 1). 

Additionally, EPA reviewed studies 

pertaining to the chronic exposure of 

lupine products. One study of the 

potential reproductive and 

developmental toxicity of lupin protein 

was identified in the literature (Ref. 2). 

Dietary administration of 20% lupin 

protein isolated from Lupinus albus 

administered to 3 generations of rats for 

270 days each (providing 7 to 35.4 

grams lupin protein/kg/bwt/day over 

the study duration) was reported to 

result in significantly decreased relative 

liver weights in both sexes in the second 

and third generation rats; however, 

these changes were not accompanied by 

any histological changes. No other 

effects on organ weights occurred, and 

the lupin protein was reported to have 

no effect on either fertility or 

reproductive parameters in any of the 

generations (Ref. 2). Studies of the 

mutagenic/genotoxic potential of lupin 

or its fractions were not identified in the 

literature, nor were traditional 

carcinogenicity studies; however, 

chronic life-time studies (i.e., 700 and 

800 days) in rats did not reveal any 

evidence of carcinogenicity in lupintreated animals, and no signs of toxicity 

or decreases in body weight occurred 

(Refs. 3 and 4). 

IV. Aggregate Exposure 

In examining aggregate exposure, 

FFDCA section 408 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 risks to humans are 

considered negligible, based on the lack 

of dietary toxicological endpoints for 

BLAD and its nontoxic mode of action 

as a fungicide. No acute, subchronic, 

mutagenic, immunotoxic, 

developmental, or chronic dietary 

hazards were identified in the studies 

and information submitted to support 

this exemption from the requirement of 

a tolerance. Based on BLAD’s lack of 

dietary toxicity hazards for mammals, 

no dietary exposure concerns are 

expected. 

1. Food. While the proposed use 

pattern may result in dietary exposure 

with possible residues in or on 

agricultural commodities, minimal to no 

risk is expected for the general 

population, including infants and 

children, or animals because BLAD has 

low toxicity, has a history of safe 

consumption and degrades rapidly. 

2. Drinking water exposure. The 

potential for transfer of BLAD to surface 

or ground water associated with 

intended use applications is considered 

minimal to non-existent due to the low 

application rate and rapid 

biodegradation of BLAD. In the unlikely 

event that residues of BLAD in water 

exceed currently existing background 

levels, the toxicity data demonstrate a 

lack of toxicity by the oral route of 

exposure. 

B. Other Non-Occupational Exposure 

Non-occupational exposure is not 

expected because BLAD will not be 

applied in residential settings. BLAD is 

applied directly to food commodities 

and degrades rapidly after application. 

1. Dermal exposure. No nonoccupational dermal exposures are 

expected to result from the agricultural 

uses of BLAD. Any dermal exposure is 

expected to be occupational in nature. 

2. Inhalation exposure. No nonoccupational inhalation exposures are 

expected to result from the agricultural 

uses of BLAD. Any inhalation exposure 

is expected to be occupational in nature. 

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 


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pesticide’s] * * * residues and other 

substances that have a common 

mechanism of toxicity.’’ 

EPA has not found BLAD to share a 

common mechanism of toxicity with 

any other substances, and BLAD does 

not appear to produce a toxic metabolite 

produced by other substances. For the 

purposes of this tolerance action, 

therefore, EPA has assumed that BLAD 

does not have a common mechanism of 

toxicity with other substances. For 

information regarding EPA’s efforts to 

determine chemicals that 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, in considering the establishment of 

a tolerance or tolerance exemption for a 

pesticide chemical residue, 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 additional safety factor when 

reliable data are available to support the 

choice of a different safety factor. 

The acute, subchronic, and 

developmental toxicity data discussed 

in Unit III. indicate that BLAD has 

negligible toxicity. In addition, BLAD is 

used in human and animal nutrition as 

a food and feed item, has a nontoxic 

mode of action against fungal pests, and 

rapidly degrades in the environment. 

EPA therefore concludes that there are 

no threshold effects of concern to 

infants, children, or adults when BLAD 

is applied as a fungicide and used in 

accordance with label directions and 

good agricultural practices. As a result, 

EPA concludes that no additional 

margin of exposure (safety) is necessary. 

Moreover, based on the same data and 

EPA analysis as presented directly 

above, EPA is able to conclude 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 

BLAD when it is applied as fungicide 

and used in accordance with label 

directions and good agricultural 

practices. 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 information 

available on BLAD do not demonstrate 

toxic potential to mammals, including 

infants and children. 

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 limitations. 

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 

United Nations 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 BLAD. 

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 BLAD. 

Therefore, an exemption from the 

requirement of a tolerance is established 

for residues of BLAD, a naturally 

occurring polypeptide from the 

catabolism of a seed storage protein (bconglutin) of sweet lupines (Lupinus 

albus), in or on food commodities when 

applied as a fungicide and used in 

accordance with label directions and 

good agricultural practices. 

IX. References 

1. U.S. EPA. 2012. Memorandum from 

Miachel Rexrode, Ph.D., Senior Biologist 

to Menyon Adams, Biologist. Request for 

a new product registration for bConglutin Section 3 with tolerance. 

Science Review of Product Chemistry, 

non-Target Organism and Toxicity Data 

in support of new product registration. 

U.S. Environmental Protection Agency 

Office of Pesticide Programs. May 24, 

2012. 

2. Ballester, D.R.; Brunser, O.; Saitua, M.T.; 

EgaAa, J.I.; Yaiiez, E.O.; Owen, D.F. 

1984. Safety evaluation of sweet lupine 

(Lupinus albus cv. Multolupa). II. Ninemonth feeding and multigeneration 

study in rats. Food and Chemical 

Toxicology 22(1):45–48. 

3. Grant, G.; Dorward, P.M.; Pusztai, A. 1993. 

Pancreatic enlargement is evident in rats 

fed diets containing raw soybeans 

(Glycine rnax) or cowpeas (Vigna 

unguiculata) for 800 days but not in 

those fed diets based on kidney beans 

(Phaseolus vulgaris) or lupinseed 

(Lupinus angustifolius). Journal of 

Nutrition 123(12):2207–2215. 

4. Grant, G.; Dorward, P.M.; Buchan, W.C.; 

Armour, J.C.; Pustzai, A. 1995. 

Consumption of diets containing raw 

soya beans (Glycine rnax), kidney beans 

(Phaseolus vulgaris), cowpeas (Vigna 

unguiculata) or lupin seeds (Lupinus 

angustifolius) by rats for up to 700 days: 

Effects on body composition and organ 

weights. British Journal of Nutrition 

73(1):17–29. 

X. Statutory and Executive Order 

Reviews 

This final rule establishes a tolerance 

under FFDCA section 408(d) 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 


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‘‘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 FFDCA section 408(d), 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 FFDCA section 408(n)(4). 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) (2 U.S.C. 1501 et seq.). 

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) (15 U.S.C. 272 note). 

XI. Congressional Review Act 

Pursuant to the Congressional Review 

Act (5 U.S.C. 801 et seq.), 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 the rule in the Federal 

Register. This action 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: February 29, 2013. 

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. Add § 180.1319 to subpart D to read 

as follows: 

§ 180.1319 Banda de Lupinus albus doce 

(BLAD); exemption from the requirement of 

a tolerance. 

An exemption from the requirement 

of a tolerance is established for the 

residues of Banda de Lupinus albus 

doce (BLAD), a naturally occurring 

polypeptide from the catabolism of a 

seed storage protein (b-conglutin) of 

sweet lupines (Lupinus albus), in or on 

all food commodities when applied as a 

fungicide and used in accordance with 

label directions and good agricultural 

practices. 

[FR Doc. 2013–06683 Filed 3–21–13; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL COMMUNICATIONS 

COMMISSION 

47 CFR Part 25 

[IB Docket No. 06–154; FCC 12–116] 

2006 Biennial Regulatory Review— 

Revision of the Commission’s Rules 

AGENCY: Federal Communications 

Commission. 

ACTION: Final rule; announcement of 

effective date. 

SUMMARY: In this document, the 

Commission announces that the Office 

of Management and Budget (OMB) has 

approved, for a period of three years, the 

information collection associated with 

the revision of the Commission’s 2006 

Biennial Regulatory Review, Report and 

Order. This notice is consistent with the 

Report and Order, which stated that the 

Commission would publish a document 

in the Federal Register announcing 

OMB approval and the effective date of 

the requirements. 

DATES: The amendments to 47 CFR 

25.110 and 25.137, published at 78 FR 

8417, February 6, 2013, are effective 

March 22, 2013. 

FOR FURTHER INFORMATION CONTACT: 

William Bell, Satellite Division, 

International Bureau, at (202) 418–0741, 

or via email at William.Bell@fcc.gov. 

SUPPLEMENTARY INFORMATION: This 

document announces that, on February 

6, 2013, OMB approved, for a period of 

three years, the information collection 

requirements contained in the 

Commission’s Report and Order, FCC 

12–116, published at 78 FR 8417, 

February 6, 2013. The OMB Control 

Number is 3060–0678. The Commission 

publishes this notice as an 

announcement of the effective date of 

the requirements. 

Synopsis 

As required by the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3507), 

the FCC is notifying the public that it 

received OMB approval on February 6, 

2013, for the information collection 

requirements contained in the 

Commission’s rules at 47 CFR 25.110 

and 25.137. 

Under 5 CFR part 1320, an agency 

may not conduct or sponsor a collection 

of information unless it displays a 

current, valid OMB Control Number. 

No person shall be subject to any 

penalty for failing to comply with a 

collection of information subject to the 

Paperwork Reduction Act that does not 

display a current, valid OMB Control 

Number. The OMB Control Number is 

3060–0678. 

The foregoing notice is required by 

the Paperwork Reduction Act of 1995, 

Public Law 104–13, October 1, 1995, 

and 44 U.S.C. 3507. 

The total annual reporting burdens 

and costs for the respondents are as 

follows: 

OMB Control No.: 3060–0678. 

OMB Approval Date: March 13, 2013. 

OMB Expiration Date: March 31, 

2016. 

Title: Part 25 of the Federal 

Communications Commission’s Rules 

Governing the Licensing of, and 

Spectrum Usage by, Commercial Earth 

Stations and Space Stations. 

Form No.: FCC Form 312; Schedule S. 

Respondents: Business or other forprofit. 

Number of Respondents: 1,248 

respondents; 1,248 responses. 

Estimated Time per Response: 0.25– 

22 hours per response. 

Frequency of Response: On occasion 

and annual reporting requirements; 

third-party disclosure requirement; 

recordkeeping requirement. 

Obligation to Respond: Required to 

obtain or retain benefits. The statutory 

authority for this collection is contained 

in 47 U.S.C. 154, 301, 302, 303, 307, 

309, 332 and 705 unless otherwise 

noted. 

Total Annual Burden Hours: 9,765 

hours. 

Total Annual Cost Burden: 

$22,375,860. 


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