[Federal Register Volume 78, Number 56 (Friday, March 22, 2013)]
[Rules and Regulations]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06683]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
Banda de Lupinus albus doce (BLAD); Exemption From the
Requirement of a Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of banda de Lupinus albus doce (BLAD), a
naturally occurring polypeptide from the catabolism of a seed storage
protein ([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
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.
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
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
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.
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
i. BLAD is used in human and animal nutrition as a food and feed
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
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
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
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
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.
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.
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
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
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
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
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
Dated: February 29, 2013.
Director, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
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