[Federal Register Volume 72, Number 147 (Wednesday, August 1, 2007)]
[Rules and Regulations]
[Pages 41931-41935]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14894]


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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.

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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:[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. 
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