[Federal Register Volume 65, Number 190 (Friday, September 29, 2000)]
[Rules and Regulations]
[Pages 58434-58437]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-24946]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301067; FRL-6748-3]
RIN 2070-AB78


Yucca 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 yucca extract on raw agricultural 
commodities when applied/used in accordance with good agricultural 
practices as an inert ingredient in pesticide formulations applied to 
growing crops. EDM Corporation submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act, as amended by the Food Quality 
Protection Act of 1996 requesting an exemption from the requirement of 
a tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of yucca extract.

DATES:  This regulation is effective September 29, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301067, 
must be received by EPA on or before November 28, 2000.

ADDRESSES:  Written objections and hearing requests may be submitted by 
mail, in person, or by courier. Please follow the detailed instructions 
for each method as provided in Unit VIII. of the SUPPLEMENTARY 
INFORMATION. To ensure proper receipt by EPA, your objections and 
hearing requests must identify docket control number OPP-301067 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Vera Soltero, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; 
telephone number: (703) 308-9359; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

     You may be affected by this action if you are an agricultural 
producer, food manufacturer, or pesticide manufacturer. Potentially 
affected categories and entities may include, but are not limited to:

------------------------------------------------------------------------
                                                          Examples of
           Categories                 NAICS codes         potentially
                                                       affected entities
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Industry........................  111                 Crop production
                                  112                 Animal production
                                  311                 Food manufacturing
                                  32532               Pesticide
                                                       manufacturing
------------------------------------------------------------------------

     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 the table could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether or not this action might apply to certain entities. If you have 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

B. How Can I Get Additional Information, Including Copies of this 
Document and Other Related Documents?

     1. Electronically. You may obtain electronic copies of this 
document, and certain other related documents that might be available 
electronically, from the EPA Internet Home Page at http://www.epa.gov/. 
To access this document, on the Home Page select ``Laws and 
Regulations,'' ``Regulations and Proposed Rules,'' and then look up the 
entry for this document under the ``Federal Register--Environmental 
Documents.'' You can also go directly to the Federal Register listings 
at http://www.epa.gov/fedrgstr/.
     2. In person. The Agency has established an official record for 
this action under docket control number OPP-301067. The official record 
consists of the documents specifically referenced in this action, and 
other information related to this action, including any information 
claimed as Confidential Business Information (CBI). This official 
record includes the documents that are physically located in the 
docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

II. Background and Statutory Findings

    In the Federal Register of November 20, 1998 (63 FR 64494) (FRL-
6027-7), EPA issued a notice pursuant to section 408 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, as amended by the 
Food Quality Protection Act (FQPA) (Public Law 104-170) announcing the 
filing of a pesticide tolerance petition by, EDM Corporation, 2278 S. 
Indiana St., Porterville, CA 93257. This notice included a summary of 
the petition prepared by the petitioner EDM Corporation. There were no 
comments received in response to the notice of filing.
     The petition requested that 40 CFR 180.1001(d) be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of yucca extract.
     Section 408(b)(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 tolerance is ``safe.'' Section 408(b)(2)(A)(ii) defines ``safe'' to 
mean that ``there is a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) requires EPA to give 
special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue....''
     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 FFDCA, EPA has reviewed 
the available scientific data and other relevant information in support 
of this

[[Page 58435]]

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. The nature of the toxic effects caused by are 
discussed in this unit.
     An acute oral gavage toxicity study performed on Sprague-Dawley 
derived rats was performed on a 70% yucca extract syrup. The 
LD50 for males was found to be greater than 5,000 milligram/
kilogram (mg/kg), and for females it was calculated to be greater than 
500 mg/kg. Even though the use of a 70% extract is a minor deviation 
from accepted guidelines, the Agency concluded that yucca extract 
belonged in Toxicity Category III. Thus, there are no concerns for 
acute oral exposure.
    Yucca extract has been historically used among the Native American 
population in Mexico and the United States for medicinal purposes. It 
was approved by the U.S. Food and Drug Administration (FDA) as a 
natural food additive under 21 CFR 172.510. Furthermore, it has been 
used as a dietary supplement without evidence of toxicity. For these 
reasons, the Agency has concluded there are no concerns for chronic 
oral exposure, and that chronic toxicity data were not necessary.

IV. Aggregate Exposures

     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

    Yucca extract is derived from the species Yucca schidigera which is 
part of the lily family of plants and is native to the deserts of 
Southwestern United States and Northern Baja California, Mexico. The 
plant and its extracts have a long history of safe use as food material 
for both humans and livestock. It is used for human consumption in the 
soft drink industry, natural food supplement, cosmetics, etc. Other 
uses include: natural feed additive for livestock, poultry, swine, 
pets, and shrimp to reduce ammonia, hydrogen sulfide and offensive 
odors. The extract is approved by the FDA as a natural food additive 
under 21 CFR 172.510.
    1. Food. Information supplied to the Agency indicates that 
approximately 350 tons of raw yucca material are used annually in the 
United States. It is expected that 150 tons of these materials would be 
used in making yucca extract for agricultural uses. A 70% yucca extract 
solution would be used in pesticide products in a concentration no 
greater than 6%. If yucca extract is approved as an inert ingredient in 
pesticide products to be applied to food crops, it can be assumed that 
exposure to yucca extract will increase. However, the amount of 
increase is necessarily limited by the availability of raw yucca. In 
addition, the main ingredient in yucca extract is sarsaponin which is 
naturally found in several types of food, such as legumes and asparagus 
at significant levels. The Agency concludes that the use of yucca 
extract as an inert ingredient would result in a negligible increase in 
exposure over those levels which would occur as the result of the use 
of yucca extract as an unrestricted food additive or naturally as the 
result of ingestion of various food items.
    2. Drinking water exposure. Yucca extract has general history of 
safe use as a natural food additive approved by the FDA under 21 CFR 
172.510 present in dietary supplements, herbal teas, soft drinks, among 
others. The main ingredient in yucca extract, sarsaponin, has been 
shown to degrade in 60 deg.C water within 8 days. Because of this rapid 
degradation, the lack of toxicity and its history of safe use, the 
Agency is confident that the use of yucca extract as a food-use inert 
ingredient in pesticide products will not affect the water supply.

B. Other Non-Occupational Exposure

    On October 6, 1998, the Agency approved the use of yucca extract as 
a non-food use inert ingredient in pesticide formulations applied to 
grasses grown for seeds and for sod. No data was required for this 
approval. The Agency has determined that due to the long history of 
safe use as a dietary supplement and food additive, there is no need 
for the petitioners to submit dermal and inhalation exposure data.

V. Cumulative Effects

    Section 408 (b)(2)(D)(v) of FFDCA requires that, when considering 
whether to establish, modify or revoke a tolerance or tolerance 
exemption, the Agency consider available information concerning the 
cumulative effects of a particular chemical's residues and other 
substances that have a common mechanism of toxicity. The Agency has not 
made any conclusions as to whether or not yucca extract shares a common 
mechanism of toxicity with other chemicals. However, yucca extract is 
expected to be practically non-toxic to mammals. Due to the expected 
lack of toxicity, a cumulative risk assessment is not necessary.

VI. Determination of Safety for U.S. Population, Infants and 
Children

    Yucca extract has been approved for use in food and beverages by 
the FDA under 21 CFR 172.510 with no limits. As previously stated in 
sections A1 and A2, approval of yucca extract as an inert ingredient 
for use on food crops will not significantly increase dietary exposure 
to this chemical. Accordingly, there is reasonable certainty that no 
harm will result from aggregate exposure of the U.S. population, 
including infants and children, to yucca extract.
    The Agency did not use the safety factor analysis in evaluating the 
risk posed by the compound. The lack of toxicity of yucca extract 
supported not applying an additional tenfold safety factor to protect 
infants and children. In conclusion, the Agency is reasonably certain 
that no harm will result to infants and children, or to the general 
population from aggregate exposure to residues of yucca extract. 
Accordingly, EPA finds that exempting yucca extract from the 
requirement of a tolerance will be safe.

VII. Other Considerations

A. Endocrine Disruptors

    FQPA requires EPA to develop a screening program to determine 
whether certain substances, including pesticides and inert ingredients, 
may have an effect in humans that is similar to an effect produced by a 
naturally occurring estrogen, or such other endocrine effect.... The 
Agency has been working with interested stakeholders to develop a 
screening and testing program as well as a priority-setting scheme. As 
the Agency proceeds with implementation of this program, further 
testing of products containing the inert ingredient yucca extract for 
endocrine effects may be required. At this moment, there is no evidence 
that yucca extract is an endocrine disruptor.

B. Analytical Method(s)

    Since an exemption from the requirement of a tolerance is being 
established without restriction on residue level, the Agency has 
concluded that an analytical method is not required for enforcement 
purposes for yucca extract from Yucca schidigera.

[[Page 58436]]

C. Existing Tolerance Exemptions

    There are no existing tolerance exemptions for yucca extract from 
Yucca schidigera.

D. International Tolerances

    There are no international tolerances or tolerance exemptions for 
yucca extract from Yucca schidigera.

E. Conclusion

    Therefore, based on the information and the data considered, EPA is 
establishing an exemption from the requirement of a tolerance for 
residues of yucca extract from Yucca schidigera.

VIII. Objections and Hearing Requests

    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. Although the procedures in those 
regulations require some modification to reflect the amendments made to 
the FFDCA by the FQPA of 1996, EPA will continue to use those 
procedures, with appropriate adjustments, until the necessary 
modifications can be made. The new section 408(g) provides essentially 
the same process for persons to ``object'' to a regulation for an 
exemption from the requirement of a tolerance issued by EPA under new 
section 408(d), as was provided in the old FFDCA sections 408 and 409. 
However, the period for filing objections is now 60 days, rather than 
30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

    You must file your objection or request a hearing on this 
regulation in accordance with the instructions provided in this unit 
and in 40 CFR part 178. To ensure proper receipt by EPA, you must 
identify docket control number OPP-301067 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 November 
28, 2000.
    1. Filing the request. Your objection must specify the specific 
provisions in the regulation that you object to, and the grounds for 
the objections (40 CFR 178.25). If a hearing is requested, the 
objections must include a statement of the factual issues(s) on which a 
hearing is requested, the requestor's contentions on such issues, and a 
summary of any evidence relied upon by the objector (40 CFR 178.27). 
Information submitted in connection with an objection or hearing 
request may be claimed confidential by marking any part or all of that 
information as CBI. Information so marked will not be disclosed except 
in accordance with procedures set forth in 40 CFR part 2. A copy of the 
information that does not contain CBI must be submitted for inclusion 
in the public record. Information not marked confidential may be 
disclosed publicly by EPA without prior notice.
    Mail your written request to: Office of the Hearing Clerk (1900), 
Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460. You may also deliver your request to the Office 
of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., 
Washington, DC 20460. The Office of the Hearing Clerk is open from 8 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Office of the Hearing Clerk is (202) 260-4865.
    2. Tolerance fee payment. If you file an objection or request a 
hearing, you must also pay the fee prescribed by 40 CFR 180.33(i) or 
request a waiver of that fee pursuant to 40 CFR 180.33(m). You must 
mail the fee to: EPA Headquarters Accounting Operations Branch, Office 
of Pesticide Programs, P.O. Box 360277M, Pittsburgh, PA 15251. Please 
identify the fee submission by labeling it ``Tolerance Petition Fees.''
     EPA is authorized to waive any fee requirement ``when in the 
judgement of the Administrator such a waiver or refund is equitable and 
not contrary to the purpose of this subsection.'' For additional 
information regarding the waiver of these fees, you may contact James 
Tompkins by phone at (703) 305-5697, by e-mail at [email protected], 
or by mailing a request for information to Mr. Tompkins at Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    If you would like to request a waiver of the tolerance objection 
fees, you must mail your request for such a waiver to: James Hollins, 
Information Resources and Services Division (7502C), Office of 
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460.
    3. Copies for the Docket. In addition to filing an objection or 
hearing request with the Hearing Clerk as described in Unit VIII.A., 
you should also send a copy of your request to the PIRIB for its 
inclusion in the official record that is described in Unit I.B.2. Mail 
your copies, identified by docket control number OPP-301067, to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. 
In person or by courier, bring a copy to the location of the PIRIB 
described in Unit I.B.2. You may also send an electronic copy of your 
request via e-mail to: [email protected]. Please use an ASCII file 
format and avoid the use of special characters and any form of 
encryption. Copies of electronic objections and hearing requests will 
also be accepted on disks in WordPerfect 6.1/8.0 file format or ASCII 
file format. Do not include any CBI in your electronic copy. You may 
also submit an electronic copy of your request at many Federal 
Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing?

    A request for a hearing will be granted if the Administrator 
determines that the material submitted shows the following: There is a 
genuine and substantial issue of fact; there is a reasonable 
possibility that available evidence identified by the requestor would, 
if established resolve one or more of such issues in favor of the 
requestor, taking into account uncontested claims or facts to the 
contrary; and resolution of the factual issues(s) in the manner sought 
by the requestor would be adequate to justify the action requested (40 
CFR 178.32).

IX. Regulatory Assessment Requirements

    This final rule establishes an exemption from the tolerance 
requirement under FFDCA section 408(d) 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 October 4, 1993 (58 FR 
51735). 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., or 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). Nor does it require any 
prior consultation as specified by Executive Order 13084, entitled 
Consultation and Coordination with Indian Tribal Governments May 19, 
1998 (63 FR 27655); special considerations as required by Executive 
Order 12898, entitled Federal Actions to Address Environmental Justice 
in Minority Populations and Low-Income Populations February 16, 1994 
(59 FR 7629); or require OMB review or any Agency action under 
Executive Order

[[Page 58437]]

13045, entitled Protection of Children from Environmental Health Risks 
and Safety Risks April 23, 1997 (62 FR 19885). 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). Since 
tolerances and exemptions that are established on the basis of a 
petition under FFDCA section 408(d), such as the 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. In addition, the Agency has determined that this 
action will not have a substantial direct effect on States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government, as specified in Executive Order 13132, entitled Federalism 
August 10, 1999 (64 FR 43255). Executive Order 13132 requires EPA to 
develop an accountable process to ensure ``meaningful and timely input 
by State and local officials in the development of regulatory policies 
that have federalism implications.'' ``Policies that have federalism 
implications'' is defined in the Executive Order to include regulations 
that have ``substantial direct effects on the States, on the 
relationship between the national government and the States, or on the 
distribution of power and responsibilities among the various levels of 
government.'' This final rule directly regulates growers, food 
processors, food handlers and food retailers, not States. 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).

X. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
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: September 21, 2000.

Peter Caulkins,

Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

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

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

    2. In Sec. 180.1001, the table in paragraph (d) is amended by 
adding alphabetically the following inert ingredient to read as 
follows:


Sec. 180.1001  Exemptions from the requirement of a tolerance.

* * * * *
    (d)* * * 

 
------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
              *        *        *        *        *
Yucca extract from Yucca          ..................  Wetting agent
 schidigera.
              *        *        *        *        *
------------------------------------------------------------------------

* * * * *

[FR Doc. 00-24946 Filed 9-28-00; 8:45 am]
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