Document ID: EPA-HQ-OPP-2015-0230-0001
Agency: epa
Document Type: Proposed Rule
Title: Pesticide Tolerances: Banda de Lupinus albus doce BLAD
Posted Date: 2015-05-29T04:00Z

[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Proposed Rules]
[Pages 30640-30644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12530]

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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.

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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).

[[Page 30641]]

     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 
[gamma]-conglutin and not to lupine [beta]-conglutin, 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

[[Page 30642]]

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 [beta]-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 
end-use 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 [beta]-conglutin, a main storage protein in the flowering 
plant sweet lupines (Lupinus albus). BLAD protein is produced by 
breakdown of [beta]-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 re-examined the potential allergenicity 
of BLAD because of the concern raised about potential sensitivity of 
peanut-sensitive individuals. The following observations raised new 
questions about the potential for BLAD to pose an allergenicity 
concern:
    1. BLAD comprises an internal segment of [beta]-conglutin;
    2. [beta]-conglutin exhibits a relatively strong homology to the 
other members of the vicillin family, including well-known 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

[[Page 30643]]

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 non-occupational, 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.

[[Page 30644]]

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]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
3. Section 180.683 is added to read as follows:

Sec.  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.

------------------------------------------------------------------------
                                                               Parts per
                          Commodity                             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]

Sec.  180.1319  [Removed and Reserved]

0
3. Remove and reserve Sec.  180.1319.
[FR Doc. 2015-12530 Filed 5-28-15; 8:45 am]
 BILLING CODE P