30640 Federal Register / Vol. 80, No. 103 / Friday, May 29, 2015 / Proposed Rules 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for Part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 

33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 0170.1. 

■ 2. Add a new § 165.T0286 to read as 

follows: 

§ 165.T0286 Safety Zone for the Fall River 

Grand Prix, Mt. Hope Bay and Taunton 

River, Fall River, MA. 

(a) Location. The following area is a 

safety zone: Mt. Hope Bay and the 

Taunton River navigation channel from 

approximately Mt. Hope Bay buoy R10 

southwest of Brayton Point channel, and 

extending approximately two miles to 

the northeast up to and including Mt. 

Hope Bay buoy C17 north of the Braga 

Bridge. The safety zone is encompassed 

by the following coordinates: 

Corner Latitude Longitude 

SW ............ 41°41.40′ N. 71°11.15′ W. 

NW ............ 41°41.48′ N. 71°11.15′ W. 

SE ............. 41°42.33′ N. 71°09.40′ W. 

NE ............. 41°42.42′ N. 71°09.47′ W. 

(b) Enforcement Period. Vessels will 

be prohibited from entering this safety 

zone, when enforced, during the Fall 

River Grand Prix marine event between 

9 a.m. and 5 p.m. from Friday, August 

14, 2015 to Sunday, August 16, 2015. 

(c) Definitions. The following 

definitions apply to this section: 

(1) Designated Representative. A 

‘‘designated representative’’ is any Coast 

Guard commissioned, warrant or petty 

officer of the U.S. Coast Guard who has 

been designated by the Captain of the 

Port, Sector Southeastern New England 

(COTP), to act on his or her behalf. The 

designated representative may be on an 

official patrol vessel or may be on shore 

and will communicate with vessels via 

VHF–FM radio or loudhailer. In 

addition, members of the Coast Guard 

Auxiliary may be present to inform 

vessel operators of this regulation. 

(2) Official Patrol Vessels. Official 

patrol vessels may consist of any Coast 

Guard, Coast Guard Auxiliary, state, or 

local law enforcement vessels assigned 

or approved by the COTP. 

(3) Patrol Commander. The Coast 

Guard may patrol each safety zone 

under the direction of a designated 

Coast Guard Patrol Commander. The 

Patrol Commander may be contacted on 

Channel 16 VHF–FM (156.8 MHz) by 

the call sign ‘‘PATCOM.’’ 

(4) Spectators. All persons and vessels 

not registered with the event sponsor as 

participants or official patrol vessels. 

(d) Regulations. (1) The general 

regulations contained in 33 CFR 165.23 

as well as the following regulations 

apply to the safety zone established in 

conjunction with the Fall River Grand 

Prix, Taunton River, vicinity of Fall 

River, MA. These regulations may be 

enforced for the duration of the event. 

(2) No later than 8 a.m. each day of 

the event, the Coast Guard will 

announce via Safety Marine Information 

Broadcasts and local media the times 

and duration of each race scheduled for 

that day, and the precise area(s) of the 

safety zone that will be enforced. 

(3) Vessels may not transit through or 

within the safety zone during periods of 

enforcement without Patrol Commander 

approval. Vessels permitted to transit 

must operate at a no-wake speed, in a 

manner which will not endanger 

participants or other crafts in the event. 

(4) Spectators or other vessels shall 

not anchor, block, loiter, or impede the 

movement of event participants or 

official patrol vessels in the safety zone 

unless authorized by an official patrol 

vessel. 

(5) The Patrol Commander may 

control the movement of all vessels in 

the safety zone. When hailed or signaled 

by an official patrol vessel, a vessel shall 

come to an immediate stop and comply 

with the lawful directions issued. 

Failure to comply with a lawful 

direction may result in expulsion from 

the area, citation for failure to comply, 

or both. 

(6) The Patrol Commander may delay 

or terminate the Fall River Grand Prix 

at any time to ensure safety. Such action 

may be justified as a result of weather, 

traffic density, spectator operation or 

participant behavior. 

Dated: May 8, 2015. 

J.T. Kondratowicz, 

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

Port Southeastern New England. 

[FR Doc. 2015–12736 Filed 5–28–15; 8:45 am] 

BILLING CODE 9110–04–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 180 

[EPA–HQ–OPP–2015–0230; FRL–9927–02] 

RIN 2070–ZA16 

Banda de Lupinus albus doce BLAD; 

Proposed Pesticide Tolerance 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Proposed rule. 

SUMMARY: EPA proposes to revoke the 

current exemption from the requirement 

for a tolerance for residues of banda de 

Lupinus albus doce (BLAD) in or on all 

food commodities. In its place, EPA 

proposes to establish a tolerance 

limiting residues of BLAD to 0.005 parts 

per million (ppm) in or on almonds, 

grapes, strawberries and tomatoes. The 

Agency is undertaking this action under 

the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 

DATES: Comments must be received on 

or before July 28, 2015. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPP–2015–0230, 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 

Confidential Business Information (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.html. 

Additional instructions on 

commenting or visiting the docket, 

along with more information about 

dockets generally, is available at 

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

FOR FURTHER INFORMATION CONTACT: 

Robert McNally, Director, Biopesticides 

and Pollution Prevention Division 

(7511P), Office of Pesticide Programs, 

Environmental Protection Agency, 1200 

Pennsylvania Ave. NW., Washington, 

DC 20460–0001; main telephone 

number: (703) 305–7090; email address: 

BPPDFRNotices@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 

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). 


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• Pesticide manufacturing (NAICS 

code 32532). 

B. What should I consider as I prepare 

my comments for EPA? 

1. Submitting CBI. Do not submit this 

information to EPA through 

regulations.gov or email. Clearly mark 

the part or all of the information that 

you claim to be CBI. For CBI 

information on a disk or CD–ROM that 

you mail to EPA, mark the outside of the 

disk or CD–ROM as CBI and then 

identify electronically within the disk or 

CD–ROM the specific information that 

is claimed as CBI. In addition, to one 

complete version of the comment that 

includes information claimed as CBI, a 

copy of the comment that does not 

contain the information claimed as CBI 

must be submitted for inclusion in the 

public docket. Information so marked 

will not be disclosed except in 

accordance with procedures set forth in 

40 CFR part 2. 

2. Tips for preparing your comments. 

When preparing and submitting your 

comments, see the commenting tips at 

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

comments.html. 

II. This Proposal 

A. What is the authority for this action? 

EPA is taking this action under 

section 408(e) the FFDCA, 21 U.S.C. 

346a(e), which allows EPA to initiate a 

tolerance action under FFDCA section 

408, 21 U.S.C. 346a et seq. FFDCA 

section 408(b)(2)(A)(i) allows EPA to 

establish a tolerance (the legal limit for 

a pesticide chemical residue in or on a 

food) only if EPA determines that the 

tolerance is ‘‘safe.’’ FFDCA section 

408(b)(2)(A)(ii) 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. 

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

EPA to give special consideration to 

exposure of infants and children to the 

pesticide chemical residue in 

establishing a tolerance and to ‘‘ensure 

that there is a reasonable certainty that 

no harm will result to infants and 

children from aggregate exposure to the 

pesticide chemical residue . . .’’ 

Section 408(c)(2)(A)(ii) contains the 

same safety standard for establishing or 

leaving in effect an exemption from the 

requirement of a tolerance. Section 

408(c)(2)(A)(i) requires the Agency to 

modify or revoke an exemption if the 

Agency determines it is not safe. 

EPA performs a number of analyses to 

determine the risks from aggregate 

exposure to pesticide residues. For 

further discussion of the regulatory 

requirements of FFDCA section 408 and 

a complete description of the risk 

assessment process, see http://

www.epa.gov/pesticides/regulating/

tolerances.htm. 

B. What action is the Agency taking? 

EPA, on its own initiative under 

FFDCA section 408(c)(1)(B), is 

proposing to revoke the existing 

exemption from the requirement of a 

tolerance for residues of the fungicide 

BLAD in or on all food commodities as 

established in the Federal Register of 

March 22, 2013 (78 FR 17600) (FRL– 

9380–6). In addition, EPA is proposing 

to establish a tolerance under FFDCA 

section 408(e) for residues of the 

fungicide BLAD, in or on almonds, 

grapes, strawberries, and tomatoes at the 

level of detection of 0.005 ppm. 

EPA is taking this action in response 

to concerns that were raised by the 

Federal Drug Administration (FDA) 

about the potential allergenicity of 

BLAD for peanut-sensitive individuals 

following EPA’s promulgation of the 

tolerance exemption of BLAD on all 

food commodities. Based on the 

potential uncertainty raised by those 

concerns, EPA sought additional data 

from the petitioner and reexamined the 

safety of the BLAD tolerance exemption. 

Following an assessment of the 

additional data that was provided, EPA 

has concluded that the available data 

supports establishing a more limited 

tolerance at the level of detection on 

specific commodities. 

III. Regulatory Background 

In the Federal Register of March 22, 

2013, EPA established a tolerance 

exemption for residues of BLAD in or on 

all food commodities when applied as a 

fungicide and used in accordance with 

label directions and good agricultural 

practices. EPA established this tolerance 

exemption following the receipt of a 

petition from Consumo Em Verde S.A, 

Biotecnologia De Plantas, Parque 

Technologico de Cantanhede (CEV) in 

2012. All of the data requirements to 

support the exemption from the 

requirement of a tolerance were 

fulfilled, and following an assessment of 

all available data, EPA concluded that 

there was a reasonable certainty that no 

harm will result to the U.S. population, 

including infants and children, from 

aggregate exposure to residues of BLAD. 

Following EPA’s establishment of a 

tolerance exemption for residues of 

BLAD on all food commodities, FDA 

raised concerns about the potential 

allergenicity of the BLAD protein for 

peanut-sensitive individuals. EPA’s 

original review of the data in support of 

the establishment of a tolerance 

exemption had considered BLAD’s 

potential allergenicity and concluded 

that the use of BLAD as pesticide would 

not result in any meaningful exposure to 

human health and the environment 

based on the following considerations. 

First, because lupines are commonly 

used in human and animal nutrition as 

a food and feed, EPA concluded that 

any dietary contribution from use of 

BLAD as a pesticide would be relatively 

limited. Second, the weight of evidence 

regarding the BLAD protein suggested 

low risk for allergenicity concerns upon 

application of the criteria set by the 

Codex Alimentarius (2003) and the 

Food and Agricultural Organizations of 

the United Nations/World Health 

Organization (FAO/WHO) (2001): 

• Amino acid homology: Having an 

amino acid residue similarity of greater 

than 35% over a sequence of 80 amino 

acids of a known allergenic protein (Ara 

h 1). Residues 5 to 169 in BLAD exhibit 

a 58% sequence homology when 

compared to residues 148 to 312 in Ara 

h 1, which is similar to other legume 

seed storage proteins; 

• Having one or more sets of more 

than 6 contiguous amino acid residues 

that are identical to amino acids of a 

known allergenic protein. BLAD 

contains only one stretch of contiguous 

amino acid residues identical to Ara h 

1; as a comparison there are 2 in lupine 

and bean vicilin, 3 in pea and broad 

bean vicilin, and 5 in soybeans. This 

observation suggests a more likely 

presence of IgE recognition epitopes on 

the vicilins rather than on BLAD; 

• Serum cross-reactivity to known 

allergens: Moneret-Vautrin et al., 1999 

found that although peanut-lupine 

cross-reactivity allergenic potential is 

high, it presumably corresponds to 

lupine g-conglutin and not to lupine bconglutin, the precursor of BLAD; 

• Pepsin resistance: BLAD is readily 

degraded by proteolytic enzymes and 

• Expression levels: Using 

immunological methods, residual levels 

of BLAD were not detectable 18 hours 

after application to tomatoes, relative to 

controls. 

This information was used by the EPA 

to conclude that BLAD is not likely to 

be an allergen. 

Nonetheless, FDA expressed concerns 

about the potential allergenicity of 

BLAD because lupine is known to incite 

food allergy in sensitive individuals and 

because of reports of cross-reactivity to 

lupine protein in peanut sensitive 


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individuals. In response to these newly 

raised concerns, EPA decided to 

investigate further the issues raised by 

FDA and seek additional data, including 

a skin prick (in vivo) test on Ara h 1 

peanut/lupine sensitive individuals and 

an in vitro immunological testing on 

serum from Ara h 1 peanut/lupine 

sensitive individuals. The focus on Ara 

h 1 sensitive individuals is due to the 

similarity of the b-conglutin parent 

molecule of BLAD to the Ara h 1 

allergen and reports of cross reactivity 

in peanut-sensitive individuals to 

lupine protein. 

In addition, EPA required residue 

chemistry field trials conducted on 

crops listed on the proposed pesticide 

label using PROBLAD PLUS, the enduse pesticide containing the BLAD 

protein, at label rates and exaggerated 

application rates (5X) to establish a rate 

of decline and residue levels of BLAD 

on crops tested. Upon receipt of all the 

new information, EPA reexamined the 

safety of BLAD. 

IV. Aggregate Risk Assessment and 

Determination of Safety 

A. EPA’s Safety Determination 

EPA has evaluated the available 

toxicity and exposure data and 

considered its validity, completeness, 

and reliability, as well as the 

relationship of the results of the studies 

to human risk. Based upon that 

evaluation, EPA concludes that there is 

a reasonable certainty that no harm will 

result to the general population, or to 

infants and children, from aggregate 

exposure to BLAD residues under the 

tolerance proposed in this action. 

EPA’s assessment of exposures and 

risks associated with BLAD is discussed 

in this unit of the document. 

B. Toxicological Profile 

EPA has evaluated the available 

toxicity data and considered its validity, 

completeness, and reliability as well as 

the relationship of the results of the 

studies to human risk. EPA has also 

considered available information 

concerning the variability of the 

sensitivities of major identifiable 

subgroups of consumers, including 

infants and children. 

BLAD is a naturally occurring 20 kilo 

Dalton (kDa) polypeptide fragment of 

b-conglutin, a main storage protein in 

the flowering plant sweet lupines 

(Lupinus albus). BLAD protein is 

produced by breakdown of b-conglutin 

during day 4 to 12 of the germination 

process of the sweet lupines. Data 

submitted and reviewed by the Agency 

demonstrate that BLAD operates in a 

non-toxic manner. BLAD, which is used 

as a fungicide, degrades chitin by 

catalyzing and successfully removing 

the N-acetyl-D-glucosamine terminal 

monomers, resulting in the destruction 

of the fungal cells. There is a history of 

safe use in human and livestock 

consumption; however, there may be a 

potential for allergenicity with some 

sensitive populations. 

All of the toxicity data requirements 

have been fulfilled. EPA has concluded 

that the data are acceptable and no 

additional data are required. Data on the 

end-use product, PROBLAD PLUS, 

containing BLAD as its active 

ingredient, did not indicate toxicity 

endpoints. The toxicological 

information showed that PROBLAD 

PLUS has a low toxicity profile as noted 

in the test results for the following 

studies: Acute Oral Lowest Dose (LD)50

> 5,000 milligram/kilogram (mg/kg); 

Acute Dermal LD50 > 2,000 mg/kg; 

Acute Inhalation LC50 > 5.34 milligram/ 

Liter (mg/L); Primary Eye Irritation was 

slight; Primary Dermal Irritation was 

mild to slight; and PROBLAD PLUS is 

not a contact dermal sensitizer. 

Moreover, there are no known effects on 

endocrine systems via oral, dermal, or 

inhalation exposure. Therefore, the 

Agency concludes that there are no 

toxicity risks with BLAD. 

As noted in Unit III., EPA reexamined the potential allergenicity of 

BLAD because of the concern raised 

about potential sensitivity of peanutsensitive individuals. The following 

observations raised new questions about 

the potential for BLAD to pose an 

allergenicity concern: 

1. BLAD comprises an internal 

segment of b-conglutin; 

2. b-conglutin exhibits a relatively 

strong homology to the other members 

of the vicillin family, including wellknown allergens contained in peanuts 

and soybeans (specifically Ara h 1); and 

3. There are a considerable number of 

studies concerning the allergenicity of 

lupine-derived products. 

EPA then evaluated the reactivity to 

BLAD in sensitive individuals. 

A Skin Prick Test (SPT) with lupine 

or peanut extracts in order to establish 

a sampling population that was 

sensitive to lupines and/or peanuts was 

submitted to the Agency. The serum 

from a sensitive population that tested 

positive to lupine/peanut exposure 

through a SPT was used to evaluate the 

capacity of cross-reactivity to BLAD in 

these sensitive individuals. Negative 

results to BLAD in IgE-specific in vitro 

immunoblot (ELISA) testing on serum 

from sensitive individuals, suggest that 

the compound is non-allergenic to 

lupine and/or peanut-sensitive 

individuals. 

Allergenicity relates to both a 

sensitizing exposure (sensitization 

leading to allergy cannot occur to a 

protein without a prior exposure) and a 

subsequent acute effect if allergy 

develops (a single exposure in a 

sensitive individual will cause a 

response). The difficulty with assessing 

allergenicity relates to determining a 

threshold level of exposure below 

which there is no reasonable 

expectation of eliciting a reaction in a 

sensitive individual. Although the new 

allergenicity data suggest that BLAD is 

not an allergen, the existing exemption 

from the requirement of a tolerance 

allows any amount of residue that might 

result from reasonably foreseeable uses 

of BLAD as a fungicide. In light of the 

similarity of BLAD to peanut allergens 

and documented allergies to lupines in 

the literature, the Agency believes the 

safety of BLAD also depends on 

demonstrating no detectable residues, in 

the absence of a demonstrated threshold 

level. 

Specific information on the studies 

received and EPA’s assessment of them 

can be found at http://

www.regulations.gov in docket ID 

number EPA–HQ–OPP–2015–0230. 

C. Toxicological Points of Departure/

Levels of Concern 

Based on the available toxicity and 

allergenicity data, the Agency did not 

identify any toxicological points of 

departure or levels of concern. 

Nevertheless, due the potential for 

allergenicity that might arise under the 

current exemption due to potentially 

unlimited exposure to residues of 

BLAD, the Agency is relying on data 

supporting a lack of exposure to BLAD 

residues on certain crops. Therefore, the 

Agency is conducting a qualitative 

assessment based on a lack of residues. 

D. Exposure Assessment 

1. Dietary exposure from food and 

feed uses. The dietary exposure to 

residues of BLAD via pesticidal use is 

expected to be negligible as, based on 

available residue data, the residues are 

below the level of detection. 

Due to the potential for allergenicity, 

field trials using PROBLAD PLUS at the 

product-labeled application rate and an 

exaggerated application rate (5X) were 

submitted in order to determine levels 

of potential exposure and the rate of 

BLAD residue degradation. Those 

studies, conducted on grapes, tomatoes 

and strawberries, showed that even with 

multiple consecutive applications at 

exaggerated application rates, the 

residue levels of BLAD will be 

negligible or non-existent. Both studies 

(involving label and exaggerated 


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application rates) showed similar 

residue measurements and a similar 

pattern with a half-life of about 2 days. 

At label application rates, grape and 

strawberry samples showed no 

detectable residues (< limit of detection 

(LOD), 0.005 ppm) of BLAD on day zero; 

tomato samples showed BLAD residues 

< limit of quantitation (LOQ) (0.0062 

ppm) on day zero but declined to < LOD 

levels one day after application. To 

ensure the reduction of any available 

residues, a one-day pre-harvest interval 

on PROBLAD PLUS labeling is being 

required. 

Additionally, due to the presence of 

an almond husk and the subsequent 

processing of almond nut meats, the 

pre-harvest use of BLAD on almonds 

following good agricultural practices 

does not represent any reasonable 

possibility of resulting in detectable 

residues on the edible nut. 

2. Dietary exposure from drinking 

water. Pesticide residues in drinking 

water are not expected because BLAD 

residues degrade rapidly in the 

environment. Specific information on 

the studies received and EPA’s 

assessment of them can be found at 

http://www.regulations.gov in docket ID 

number EPA–HQ–OPP–2015–0230. 

3. From non-dietary exposure. The 

term ‘‘residential exposure’’ is used in 

this document to refer to nonoccupational, non-dietary exposure 

(e.g., for lawn and garden pest control, 

indoor pest control, termiticides, and 

flea and tick control on pets). BLAD is 

not registered for any specific use 

patterns that would result in residential 

exposure. 

4. 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 BLAD to share a 

common mechanism of toxicity with 

any other substances, and BLAD does 

not appear to degrade into any toxic 

metabolite or other substance of 

concern. 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 

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. 

D. Safety Factor for 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 

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 (FQPA SF). 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. 

As part of its qualitative assessment, 

the Agency did not use safety factors for 

assessing risk; therefore, no additional 

safety factor is needed for assessing risk 

to infants and children. The available 

data indicate that BLAD has minimal or 

no toxicity and is not an allergen, 

especially in combination with the data 

demonstrating a lack of exposure from 

application as a pesticide. 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. 

E. Aggregate Risks and Determination of 

Safety 

Taking into consideration all available 

information on BLAD, EPA concludes 

that the potential for allergenicity of 

BLAD introduces a reasonable 

uncertainty concerning the potential for 

harm to peanut-sensitive individuals in 

light of the possibility for unlimited 

exposure to BLAD that might be 

permitted under an unlimited 

exemption from the requirement of a 

tolerance. To address that potential 

uncertainty, EPA is proposing to revoke 

the current tolerance exemption for 

BLAD in 40 CFR 180.1319. In its place, 

and in consideration of these potential 

concerns, EPA is proposing to establish 

a more limited tolerance of 0.005 ppm 

for residues of BLAD in or on almonds, 

grapes, strawberries, and tomatoes. This 

is based on crop-specific residue data on 

grapes, strawberries, and tomatoes that 

demonstrates a lack of residues on those 

specific crops. Additionally, due to the 

presence of an almond husk and the 

subsequent processing of almond nut 

meats, the pre-harvest use of BLAD on 

almonds following good agricultural 

practices does not represent any 

reasonable possibility of resulting in 

detectable residues on the edible nut. 

Therefore, under this more limited 

scenario, 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 BLAD when 

it is applied as fungicide to the 

specifically noted crops 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. Based on this information, 

EPA expects that, when used according 

to the proposed label directions, the 

tolerance for residues of BLAD on the 

listed commodities is safe, and no 

adverse effects such as allergenic 

reactions are expected to occur. 

V. Other Considerations 

A. Analytical Enforcement Methodology 

Adequate enforcement methodology 

(Enzyme-Linked Immunosorbent Assay 

(ELISA: EASI Method No: RA029 and 

RA031) is available to enforce the 

tolerance expression. 

The method may be requested from: 

Chief, Analytical Chemistry Branch, 

Environmental Science Center, 701 

Mapes Rd., Ft. Meade, MD 20755–5350; 

telephone number: (410) 305–2905; 

email address: residuemethods@

epa.gov. 

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 

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. 


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C. Trade Considerations 

The revocation of the existing 

tolerance exemption and establishment 

of tolerances for four commodities is a 

reduction in allowable residues of 

BLAD on food. Therefore, EPA intends 

to provide notice to the World Trade 

Organization (WTO) of this proposal in 

accordance with its obligations under 

the WTO’s Sanitary and Phytosanitary 

Measures Agreement. 

VI. Conclusion 

EPA proposes to revoke the existing 

tolerance exemption for residues of 

BLAD in or on all food commodities as 

established in the Federal Register of 

March 22, 2013 under section 408 of the 

FFDCA due to potential allergenicity 

concerns. In its stead, the Agency 

proposes to establish a tolerance for 

residues of BLAD in or on almonds, 

grapes, strawberries, and tomatoes at the 

level of detection of 0.005 ppm based on 

BLAD’s low toxicity profile, testing that 

indicated that BLAD is non-allergenic, 

and residue data that demonstrated a 

rapid decline of BLAD following 

application at an exaggerated rate. 

Therefore, EPA is proposing to establish 

a tolerance level at the limit of detection 

for the analytical method to prevent any 

exposure to sensitive individuals from 

potential residues of BLAD on the 

treated crops. 

VII. Statutory and Executive Order 

Reviews 

This proposed action would revoke an 

existing exemption from the 

requirement of a tolerance and establish 

new tolerances under FFDCA section 

408(e). The Office of Management and 

Budget (OMB) has exempted tolerance 

actions from review under Executive 

Orders 12866, entitled Regulatory 

Planning and Review (58 FR 51735, 

October 4, 1993), and 13563, entitled 

Improving Regulation and Regulatory 

Review (76 FR 3821, January 21, 2011). 

As a result, this action 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). Nor does it require OMB 

review or any Agency action under 

Executive Order 13045, entitled 

Protection of Children from 

Environmental Health Risks and Safety 

Risks (62 FR 19885, April 23, 1997). 

This action does not contain any 

information collections subject to OMB 

approval under the Paperwork 

Reduction Act (PRA) (44 U.S.C. 3501 et 

seq.); 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); and 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 

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

This action directly regulates growers, 

food processors, food handlers, and food 

retailers, but it does not regulate State 

or tribal governments. Nor does this 

action alter the relationships or 

distribution of power and 

responsibilities established in the 

preemption provisions of FFDCA 

section 408(n)(4). Therefore, the Agency 

has determined that Executive Orders 

13132, entitled Federalism (64 FR 

43255, August 10, 1999) and 13175, 

entitled Consultation and Coordination 

with Indian Tribal Governments (65 FR 

67249, November 9, 2000) do not apply 

to this action. In addition, this action 

does not impose any enforceable duty, 

contain any unfunded mandate, or 

otherwise significantly or uniquely 

affect small governments as described in 

the Unfunded Mandates Reform Act 

(UMRA) (2 U.S.C. 1501 et seq.). 

Under the Regulatory Flexibility Act 

(RFA) (5 U.S.C. 601 et seq.), I certify that 

this action will not have significant 

economic impact on a substantial 

number of small entities. In making this 

determination, the impact of concern is 

any significant adverse economic 

impact on small entities. An agency may 

certify that a rule will not have a 

significant economic impact on a 

substantial number of small entities if 

the action will not impose any 

requirements on small entities. There 

are not a substantial number of small 

entities affected by this rule. BLAD, 

which is currently manufactured only 

by CEV, is not being used as a pesticide 

on food at this time. Therefore, this 

action will not impose any requirements 

or have a significant impact on a 

substantial number of small entities. We 

have therefore concluded that this 

action will not impact small entities. 

List of Subjects in 40 CFR Part 180 

Environmental protection, 

Administrative practice and procedure, 

Agricultural commodities, Pesticides 

and pests, Reporting and recordkeeping 

requirements. 

Dated: March 13, 2015. 

Jack Housenger, 

Director, Office of Pesticide Programs. 

Therefore, it is proposed that 40 CFR 

chapter I be 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. 

■ 3. Section 180.683 is added to read as 

follows: 

§ 180.683 Banda de Lupinus albus doce; 

tolerances for residues. 

(a) General. Tolerances are 

established for residues of the fungicide 

banda de Lupinus albus doce (BLAD), 

including its metabolites and 

degradates, in or on the commodities in 

the table below as a result of the 

application of BLAD. Compliance with 

the tolerance levels specified below is to 

be determined by measuring only BLAD 

in or on the following commodities. 

Commodity Parts per 

million 

Almonds ...................................... 0.005 

Grapes ........................................ 0.005 

Strawberries ................................ 0.005 

Tomatoes .................................... 0.005 

(a) Section 18 emergency exemptions. 

[Reserved] 

(b) Tolerances with regional 

registrations. [Reserved] 

(c) Indirect or inadvertent residues. 

[Reserved] 

§ 180.1319 [Removed and Reserved] 

■ 3. Remove and reserve § 180.1319. 

[FR Doc. 2015–12530 Filed 5–28–15; 8:45 am] 

BILLING CODE P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Chapter I 

[EPA–HQ–OPP–2014–0818; FRL–9927–36] 

Proposal To Mitigate Exposure to Bees 

From Acutely Toxic Pesticide 

Products; Notice of Availability 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: EPA is seeking comment on a 

proposal to adopt mandatory pesticide 

label restrictions to protect managed 

bees under contract pollination services 

from foliar application of pesticides that 

are acutely toxic to bees on a contact 

exposure basis. These label restrictions 

would prohibit applications of pesticide 

products, which are acutely toxic to 

bees, during bloom when bees are 

known to be present under contract. 

EPA is also seeking comment on a 

proposal to rely on efforts made by 

states and tribes to reduce pesticide 


Lhorne on DSK2VPTVN1PROD with PROPOSALS