[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Rules and Regulations]
[Pages 17600-17604]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06683]


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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.

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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 ([beta]-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. 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: [email protected].

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

[[Page 17601]]

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/text-idx?&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 [beta]-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 [beta]-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

[[Page 17602]]

growth. (Ref. 1). More specifically, BLAD degrades chitin by catalyzing 
and successfully removing the N-acetyl-D-glucosamine 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 lupin-treated 
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 non-occupational 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 non-occupational 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 non-occupational 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

[[Page 17603]]

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 ([beta]-conglutin) 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 [beta]-Conglutin 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. Nine-month 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

[[Page 17604]]

``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]

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

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


0
2. Add Sec.  180.1319 to subpart D to read as follows:


Sec.  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 
([beta]-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