[Federal Register: August 1, 2007 (Volume 72, Number 147)]
[Rules and Regulations]
[Page 41931-41935]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au07-14]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2007-0289; FRL-8136-6]
Quillaja Saponaria Extract; 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 the biochemical pesticide Quillaja
saponaria extract in or on all food commodities. Desert King
[[Page 41932]]
Chile, Ltd. submitted a petition to EPA under the Federal Food, Drug,
and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act
of 1996 (FQPA), requesting an exemption from the requirement of a
tolerance. This regulation eliminates the need to establish a maximum
permissible level for residues of Quillaja saponaria extract.
DATES: This regulation is effective August 1, 2007. Objections and
requests for hearings must be received on or before October 1, 2007,
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: EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPP-2007-0289. To access the
electronic docket, go to http://www.regulations.gov, select ``Advanced
Search,'' then ``Docket Search.'' Insert the docket ID number where
indicated and select the ``Submit'' button. Follow the instructions on
the regulations.gov web site to view the docket index or access
available documents. All documents in the docket are listed in the
docket index available in regulations.gov. Although listed in the
index, some information is not publicly available, e.g., Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available in the electronic docket at http://www.regulations.gov, or,
if only available in hard copy, at the OPP Regulatory Public Docket in
Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal Drive,
Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m.,
Monday through Friday, excluding legal holidays. The Docket Facility
telephone number is (703) 305-5805.
FOR FURTHER INFORMATION CONTACT: Driss Benmhend, Biopesticides and
Pollution Prevention Division (7511P), Environmental Protection Agency,
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone
number: (703) 308-9525; e-mail address:Benmhend.driss@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.
Potentially affected entities may include, but are not limited to:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.
B. How Can I Access Electronic Copies of this Document?
In addition to accessing an electronic copy of this Federal
Register document through the electronic docket at http://www.regulations.gov
, you may access this ``Federal Register'' document
electronically through the EPA Internet under the ``Federal Register''
listings at http://www.epa.gov/fedrgstr. You may also access a
frequently updated electronic version of 40 CFR part 180 through the
Government Printing Office's pilot e-CFR site at http://www.gpoaccess.gov/ecfr
.
C. Can I File an Objection or Hearing Request?
Under section 408(g) of the FFDCA, as amended by the FQPA, any
person may file an objection to any aspect of this regulation and may
also request a hearing on those objections. The EPA procedural
regulations which govern the submission of objections and requests for
hearings appear in 40 CFR part 178. 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-2007-0289 in the
subject line on the first page of your submission. All requests must be
in writing, and must be mailed or delivered to the Hearing Clerk on or
before October 1, 2007.
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 that does not contain any CBI for inclusion in the public
docket that is described in ADDRESSES. Information not marked
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA
without prior notice. Submit your copies, identified by docket ID
number EPA-HQ-OPP-2007-0289, by one of the following methods.
Federal eRulemaking Portal:http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is (703) 305-5805.
II. Background and Statutory Findings
In the Federal Register of March 15, 2006 (71 FR 13388) (FRL-7768-
2), EPA issued a notice pursuant to section 408(d)(3) of the FFDCA, 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 5F6982) by Desert King Chile, Ltd., Antonio Bellet 77
OF.401, Providencia, Santiago, Chile 6640209 (submitted by Technology
Sciences Group, Inc., 1101 17th St., NW., Suite 500, Washington, DC
20026.) The petition requested that 40 CFR part 180 be amended by
establishing an exemption from the requirement of a tolerance for
residues of Quillaja saponaria extract. The notice included a summary
of the petition prepared by the petitioner Desert King Chile, Ltd.
There were no comments received in response to the notice of filing.
Section 408(c)(2)(A)(i) of the 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 the 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
[[Page 41933]]
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 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 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, section 408(b)(2)(D) of the
FFDCA requires that 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 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 section 408(b)(2)(D) of the FFDCA, EPA has 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
has also considered available information concerning the variability of
the sensitivities of major identifiable subgroups of consumers,
including infants and children.
Quillaja saponaria, commonly known as Soapbark tree, is a naturally
occurring evergreen, originally native to the South American Andes
regions. The active ingredient is a water extract from the bark of
Quillaja saponaria. Extracts of Quillaja saponaria are commonly known
as saponins, which belong to a group of naturally occurring glycosides
produced mainly by plants that form soap-like foams in aqueous
solutions. In general, saponins are found primarily in the tree bark
and wood, and to a lesser extent in the leaves. They are comprised of a
sugar moiety (typically glucose, galactose, glucuronic acid, xylose,
rhamnose, or methylpentose) linked to a hydrophobic aglycone
(sapogenin) at the C-3 (monodesmosidic) or at the C-3 and C-26 or C-28
(bidesmosidic) positions. Saponins are found in a wide variety of
plants of diverse species and many are used in human food such as baked
goods, candies, and soft drinks. Saponins can be used as a pesticide to
inhibit the growth of pathogenic fungi and nematodes in grapes and food
crops. Saponins extracted from Quillaja saponaria belong to the
bidesmosidic group, and are widely used in human foods.
The Food and Drug Administration (FDA) has classified Quillaja
saponaria extract as ``Generally Recognized as Safe'' (GRAS). Quillaja
extract is used in beverages and other foods with no report of any
adverse effects. Other saponins are widely used in commonly consumed
human food, flavoring, herbs, and spices also with no report of any
adverse effects. According to the World Health Organization (WHO 2002),
the established Average Daily Intake (ADI) of saponins from food
additives is about 5 milligrams/kilogram body weight (mg/kg bwt). This
is much higher than 0.28 mg/kg bwt which represent the calculated
average daily intake ofQuillaja saponins when used as a pesticide to
treat fruits and vegetables. Moreover, up to 100 mg saponin has been
measured in a kg of sugar extracted from sugar beets (Beta vulgaris).
According to the United States Department of Agriculture, the U.S.
consumption of sugar and sweeteners from sugar beet is over 80 kg a
year per capita, or 8,000 mg of saponins. Furthermore, soybean flour
and soybean protein has been shown to contain up to 2.5% saponin, and
it has been estimated that saponins comprise the pharmacologically
active components of approximately 30% of all medicinal plants.
In summary, the daily human exposure and intake of saponins for
consumed foods and additives and pharmaceutical products is much higher
than what would be consumed from pesticidal exposure and uses of
Quillaja saponins. This exposure has not resulted in any adverse
effects on humans. As a result, the Agency has no concerns about
dietary exposure of Quillaja saponins.
Comprehensive reviews and risk assessment have been conducted on
Quillaja saponins with regard to its toxicity to human health and have
concluded that these saponins have low acute toxicity.
1. Acute toxicity. Quillaja saponins are in Toxicity Category III
for acute oral and acute dermal toxicity, Toxicity Category I for
primary eye irritation, and Toxicity Category IV for acute inhalation
toxicity and primary dermal irritation. Quillaja saponins are not
dermal sensitizers. Based on the review and analysis of the guideline
studies, no additional toxicity data are required to support food or
non-food uses of this compound.
2. Mutagenicity, developmental toxicity, and immunotoxicity. The
applicant requested waivers for the mutagenicity (OPPTS Harmonized
Guideline 870.5100), developmental toxicity (OPPTS Harmonized Guideline
870.3700), and immunotoxicity (OPPTS Harmonized Guideline 870.7800).
Quillaja extracts are used as emulsifiers in baked goods, candies,
frozen dairy products, gelatins, and puddings. The active ingredient is
not a mutagen nor is it related to any known classes of mutagens.
Chronic feeding studies have demonstrated that Quillaja saponins are
not carcinogenic in mice or rats fed up to 2,200 mg/kg in the diet.
Saponins have been demonstrated to have anticarcinogenic properties and
to stimulate the immune system. Dietary levels of Quillaja saponin (up
to 700 ppm in feed) stimulated the immune systems of piglets fed for 20
days post-weaning (Ilsey et al., 2005). Based on the information
provided, the request for waivers of mutagenicity, developmental
toxicity, and immunotoxicity testing requirements was granted by the
Agency.
3. Subchronic toxicity. The requirement for a 90-day feeding study
(OPPTS Harmonized Guidelines 870.3100) was satisfied by submission of a
study in which Quillaja extract was administered to 15 CFE rats at
dietary concentrations equivalent to 0, 360, 1,180, or 2,470 mg/kg bwt/
day for males and 0, 440, 1,370, or 3,030 mg/kg bwt/day for females for
13 weeks. Additional groups of 5 rats were administered 0, 2.0, or 4.0%
test material for 2 weeks or 6 weeks for interim evaluations. There
were no treatment-related effects on mortality, clinical signs,
hematology and erythrocyte osmotic fragility, clinical chemistry,
urinalysis, or gross and histologic pathology. The NOAEL for the study
was the highest dose tested, 2,470 mg/kg bwt/day for males and 3,030
mg/kg bwt/day for females.
IV. Aggregate Exposures
In examining aggregate exposure, section 408 of the FFDCA 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
1. Food. The Agency is not concerned about dietary exposure to
Quillaja saponins because humans consume it regularly without any
reports of adverse
[[Page 41934]]
effects. Humans are regularly exposed toQuillaja saponins via their use
as an FDA-approved flavoring agent and food additive. Undiluted
Quillaja saponaria extracts are used in soft drinks at levels of 100-
500 mg/kg (WHO, 2002). The Joint WHO/FAO Expert Committee on Food
Additives (WHO, 2002) established an acceptable daily intake (ADI) of
Quillaja saponins of up to 5 mg/kg/day. The mean intake of Quillaja
extracts in the U.S. just from soft drinks (the major food use) is as
much as 0.54 mg/kg/day, or 11% of the ADI (WHO, 2006). According to
EPA's review and calculations using a maximum use rate for up to 6
applications per season, the exposure and average daily intake of
Quillaja saponins from treated crops is estimated to be 0.28 mg/kg bwt.
This amount is well below the established ADI of 5 mg/kg bwt (WHO,
2002). Even if the use of Quillaja saponins exceeds the maximum
proposed use rate, the Agency is not concerned about dietary exposure
because of the low toxicity of this active ingredient and the history
of its use without any reports of adverse effects.
2. Drinking water exposure. No significant drinking water exposure
and residues are expected to result from the pesticidal usage of
Quillaja saponins, especially when compared to ubiquity of the
naturally occurring saponins in the environment and their widespread
use at higher concentrations in food items and beverages. Moreover,
saponins are widely known to biodegrade quickly in the environment. As
a result, dietary and drinking water exposure to Quillaja's saponins
from product applications, are expected to be minimal.
B. Other Non-Occupational Exposure
There are no residential, school or day care uses proposed for this
product. Since the proposed use pattern is for agricultural food crops,
the potential for non-occupational, non-dietary exposures to Quillaja
saponins by the general population, including infants and children, is
highly unlikely.
1. Dermal exposure. Non-occupational dermal exposures to Quillaja
saponins when used as a pesticide are expected to be negligible because
it is limited to agricultural use.
2. Inhalation exposure. Non-occupational dermal exposures to
Quillaja saponins when used as a pesticide are expected to be
negligible because it is limited to agricultural use.
V. Cumulative Effects
Section 408(b)(2)(D)(v) of the FFDCA requires that, when
considering whether to establish an exemption from 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.'' These considerations include the
possible cumulative effects of such residues on infants and children.
EPA has considered the potential for cumulative effects of Quillaja
saponins and other substances in relation to a common mechanism of
toxicity. Common mechanisms of toxicity are not relevant to a
consideration of cumulative exposure toQuillaja saponins because the
extract is not toxic to mammalian systems. Thus, the Agency does not
expect any cumulative or incremental effects from exposure to residues
of Quillaja saponins when applied/used as directed on the label and in
accordance with good agricultural practices.
VI. Determination of Safety for U.S. Population, Infants, and Children
A. U.S. Population
There is reasonable certainty that no harm will result from
aggregate exposure to residues of Quillaja saponins to the U.S.
population, infants, and children. This includes all anticipated
dietary exposures and all other exposures for which there is reliable
information. The Agency arrived at this conclusion based on the low
level of toxicity ofQuillaja extract and the already widespread
exposure toQuillaja saponins without any reported adverse effects on
human health. The risks from aggregate exposure via oral, dermal and
inhalation exposure are a compilation of three low-risk exposure
scenarios and are negligible. Since there are no threshold effects of
concern, the provision requiring an additional margin of safety does
not apply. Moreover, Quillaja extracts are classified by the Food and
Drug Administration (FDA) as `Generally Recognized as Safe'' (GRAS),
and are also a part of the human diet when used as emulsifiers in baked
goods, candies, frozen dairy products, gelatin, and puddings (WHO,
2002). Humans have had frequent physical contact with Quillaja
saponaria with no negative health effects. Therefore, the Agency has
not used a margin of exposure (safety) approach to assess the safety of
saponins of Quillaja saponaria.
B. Infants and Children
FFDCA section 408 provides that EPA shall apply an additional
tenfold margin of exposure (also referred to as a 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
unless EPA determines that a different margin of exposure will be safe
for infants and children. Margins of exposure are often referred to as
uncertainty or safety factors. In this instance, based on all available
information, the Agency concludes that Quillaja saponaria extract is
non-toxic to mammals, including infants and children. Because there are
no threshold effects of concern to infants, children, and adults when
Quillaja saponaria extract is used as labeled, the provision requiring
an additional margin of safety does not apply. As a result, EPA has not
used a margin of exposure approach to assess the safety of Quillaja
saponins.
VII. Other Considerations
A. Endocrine Disruptors
EPA is required under section 408(p) of the FFDCA, as amended by
FQPA, to develop a screening program to determine whether certain
substances (including all pesticide active and other ingredients) ``may
have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other such endocrine effects as the
Administrator may designate.''
Quillaja saponins are not known endocrine disruptors nor is it
related to any class of known endocrine disruptors. Thus, there is no
impact via endocrine-related effects on the Agency's safety finding set
forth in this final rule for Quillaja saponins.
B. Analytical Method
Through this action, the Agency proposes to establish an exemption
from the requirement of a tolerance for the saponins extracted from
Quillaja saponaria when used on fruit and vegetable crops. For the very
same reasons that support the granting of this tolerance exemption, the
Agency has concluded that an analytical method is not required for
enforcement purposes for these proposed uses of Quillaja saponins.
C. Codex Maximum Residue Level
There are no codex maximum residue levels established forQuillaja
saponins.
VIII. Conclusions
There are no human health concerns when this food use product
containingQuillaja saponins is applied according to label use
directions. The data submitted by applicant and reviewed by the Agency
support the petition for an exemption from the requirement of a
tolerance forQuillaja saponins on food when the product is applied/used
as directed on the label
[[Page 41935]]
and in accordance with good agricultural practices.
IX. Statutory and Executive Order Reviews
This final rule establishes a tolerance under section 408(d) of
FFDCA in response to a petition submitted to the Agency. 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 rule has been
exempted from review under Executive Order 12866, this rule is not
subject to Executive Order 13211, 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, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under section 408(d) of FFDCA, such as the exemption from
the requirement of a tolerance 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, nor does this action
alter the relationships or distribution of power and responsibilities
established by Congress in the preemption provisions of section
408(n)(4) of FFDCA. As such, the Agency 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, the Agency 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 6,
2000) do not apply to this rule. In addition, This 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) (Public Law
104-4).
This action 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 of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272
note).
X. Congressional Review Act
The Congressional Review Act, 5 U.S.C. 801 et seq., generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report to each House of the Congress and to
the Comptroller General of the United States. 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 this final rule in the Federal
Register. This final rule 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: July 15, 2007.
Debra Edwards,
Director, Office of Pesticide Programs.
0
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. Section 180.1278 is added to subpart D to read as follows:
Sec. 180.1278 Quillaja saponaria extract (saponins); exemption from
the requirement of a tolerance.
Residues of the biochemical pesticide Quillaja saponaria extract
(saponins) are exempt from the requirement of a tolerance in or on all
food commodities.
[FR Doc. E7-14894 Filed 7-31-07; 8:45 am]
BILLING CODE 6560-50-S