[Federal Register Volume 65, Number 214 (Friday, November 3, 2000)]
[Rules and Regulations]
[Pages 66178-66181]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-28277]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301043; FRL-6740-9]
RIN 2070-AB78


Sodium o-nitophenolate, sodium p-nitrophenolate, sodium 5-
nitroguaiacolate, and the End-Use Product Atonik Exemption 
From the Requirement of a Tolerance and Temporary 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 active ingredients (a.i.) sodium o-
nitophenolate, sodium p-nitrophenolate, sodium 5-nitroguaiacolate, on 
all food commodities when used as Plant Growth Regulators on growing 
crops. These three a.i. comprise the end-use product ATONIK, 
ASAHI Manufacturing Company, Ltd., c/o Chemical Consultants 
International, Inc., West 98\th\ Terrace, Suite 100, Overland Park, KS, 
66212, submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act 
(FQPA) 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 sodium o-nitophenolate, sodium p-
nitrophenolate, and sodium 5-nitroguaiacolate and reassess the three 
existing tolerances for those three a.i..

DATES:  This regulation is effective November 3, 2000. Objections and 
requests for hearings, identified by docket control number OPP-301043, 
must be received by EPA on or before January 2, 2001.

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-301043 in the 
subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT:  By mail: Richard King, c/o Product 
Manager (PM) 90, Biopesticides and Pollution Prevention Division 
(7511C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460; telephone number: (703) 308-8052; 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
------------------------------------------------------------------------
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-301043. 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 July 8, 1998 (63 FR 36901) (FRL-5791-6), 
EPA issued a notice pursuant to section 408 of the FFDCA, 21 U.S.C. 
346a(e), as amended by the FQPA (Public Law 104-170) announcing the 
filing of a pesticide tolerance petition by ASAHI Manufacturing 
Company, Ltd., c/o Chemical Consultants International, Inc., West 
98\th\ Terrace, Suite 100, Overland Park, KS, 66212. This notice 
included a summary of the petition prepared by the petitioner ASAHI 
Manufacturing Company, Ltd. There were no comments received in response 
to the notice of filing.
    New 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) 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

[[Page 66179]]

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....'' 
Additionally, section 408(b)(2)(D) 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.
    The Biopesticide and Pollution Prevention Division (BPPD) has 
reviewed submitted data to assess the potential hazards and exposures 
that might result from the proposed use of ATONIK in or on 
all food commodities. The plant growth regulator will be formulated 
into an End-Use product containing a mixture of 0.6% a.i. sodium 5-
nitroguaiacolate (1%), sodium o-nitophenolate (0.2%), and sodium p-
nitrophenolate (0.3%) by weight and applied to all crops at rates of 
less than 20 grams a.i. (g a.i.) per acre. Based on the review of 
submitted information, dose levels and toxicity end-points were 
evaluated for the use of exposure estimates to characterize potential 
risks.
    The Tier I data was submitted on the end-use product, 
ATONIK, each of the three a.i., sodium o-nitrophenolate, 
sodium p-nitrophenolate, sodium 5-nitoguaiacolate, and a manufacturing 
use product (a mixture of the components). No toxicity endpoints for 
dietary, occupational or non-occupational risk charaterizations were 
indicated because:
    1. The no-observed-adverse-effect levels (N0AEL) from dietary 
administration of the a.i. are 5-6 times higher than that of the 
developmental toxicity study (1,589 and 1,723 milligrams/kilograms/day 
(mg/kg/day) for males and females compared with 300 mg/kg/day in 
pregant rats).
    2. The acute toxicity of the end-use product is classified into 
Toxicity Category IV for the oral (LD50 > 5,000 mg/kg) and 
inhalation LC50 > 5.8 mg/L) routes and Toxicity Category III 
for the dermal route (LD50 > 2,000 mg/kg).
    3. No developmental effects were noted at dose up to 600 mg/kg/day 
highest dose tested (HDT).
    4. Studies on the three components of the manufacturing use product 
(MUP) showed no mutagentic activity.
    5. The low concentration of the a.i. in the end use product (0.6%).
    6. There is a low application rate (< 20 g a.i. per acre).

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

    No toxicity endpoints for dietary, occupational or non-occupational 
risk characterizations were indicated in subchronic toxicity, 
developmental toxicity or mutagenicity studies on ATONIK or 
its three a.i.. The application rate is so low (< 20 g/acre) that 
negligible or nonexistent residues would be available for risk 
characterization. Therefore, considering the lack of toxicity and low 
exposure no risk characterizations have been conducted for 
ATONIK.
    1. Food. The end-use product, ATONIK, contains three a.i. 
(sodium 5-nitroguaiacolate, sodium o-nitophenolate, and sodium p-
nitrophenolate) in very low concentrations. At the application rates 
employed, the level of each a.i. which may be present in any of the 
food or feed items would be far below the levels which demonstrated any 
effects in the subchronic oral feeding study, the developmental 
toxicity study or the mutagenicity studies. It can be shown that in 
order to reach a dose rate comparable to the LOAEL of 1,600 mg/kg/day 
obtained in the subchronic oral feeding study, a person weighing 50 kg 
(100 lbs.) would have to consume all of the produce from 4 acres of 
crop every day.
    Further, due to the rapid uptake and metabolism of the three a.i. 
in plants, it is unlikely that any of the residue would be available 
for potential exposure.
    2. Drinking water exposure. Similarly, exposure to humans from 
consumption of water would be equally unlikely.

B. Other Non-Occupational Exposure

    Using the previously mentioned criteria, the Agency believes that 
non-occupational exposures via other routes would be highly unlikely. 
There is no allowed use of the product containing the three a.i. on 
lawns, rights-of-way, golf courses, or other areas where human exposure 
is likely to occur. Therefore, for all practical purposes, exposure 
from these areas would be non-existent.

V. Cumulative Effects

    Exposure through other pesticides and substances with the same mode 
of toxicity is not likely. What little toxicity that was observed is 
only detected at extremely high concentrations of these a.i..

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

    The three a.i. in the End-Use Product, ATONIK, are all 
classified as biochemicals. The low toxicity of each of these alone and 
in combination, as discussed above, demonstrates that these chemicals, 
at the rates established, will not pose any known risk to human health, 
either as children or as adults. These three a.i. are already exempted 
from the requirement of a tolerance for use on cotton, rice, and 
soybeans.

VII. Other Considerations

A. Endocrine Disruptors

    EPA is required under 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.'' Following the recommendations of its Endocrine Disruptor 
Screening and Testing Advisory Committee (EDSTAC), EPA determined that 
there was scientific basis for including, as part of the program, 
androgen and thyroid hormone systems, in addition to the estrogen 
hormone system. EPA also adopted EDSTAC's recommendation that the 
program include evaluations of potential effects in wildlife. For

[[Page 66180]]

pesticide chemicals, EPA will use FIFRA and, to the extent that effects 
in wildlife may help determine whether a substance may have an effect 
in humans, FFDCA authority to require the wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening Program 
(EDSP).
    When the appropriate screening and/or testing protocols being 
considered under the EDSP have been developed, sodium o-nitrophenolate, 
sodium p-nitrophenolate, and sodium 5-nitoguaiacolate, may be subjected 
to additional screening an/or testing to better characterize effects 
related to endocrine disruption. Based on the weight of the evidence of 
available data, no endocrine system-related effect have been 
identified.

B. Analytical Method(s)

    Adequate data for the end-use product, ATONIK, and each 
of the three components: sodium o-nitrophenolate, sodium p-
nitrophenolate, and sodium 5-nitoguaiacolate, were submitted with the 
initial registration and petition for tolerances.

C. Tolerance Reassessment

    The foregoing is a reassessment of the tolerances for Sec. 180.1139 
Sodium 5-nitoguaiacolate, and Sec. 180.1140 Sodium o-nitrophenolate, 
and Sec. 180.1141 Sodium p-nitrophenolate. This reassessment revises 
these tolerances to include all food commodities when used as plant 
growth regulators.

D. Codex Maximum Residue Level

    No known international tolerances have been granted for this 
pesticide. Therefore, based on the completeness and reliability of the 
toxicity data from the published literature and conservative exposure 
assessment, the Agency concludes that there is a reasonable certainty 
that no harm will result from aggregate exposure to residues of 
ATONIK including all anticipated dietary exposure and all 
non-occupational exposures.

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-301043 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 January 
2, 2001.
    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-301043, 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

[[Page 66181]]

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 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: October 6, 2000.

Janet L. Andersen,

Director, Biopesticides and Pollution Prevention Division.

    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), 346(a) and 374.

    2. In subpart D Sec. 180.1139, 180.1140, and 180.1141 are revised 
to read as follows:


Sec. 180.1139  Sodium 5-nitroguaiacolate; exemption from the 
requirements of a tolerance.

    The biochemical sodium 5-nitroguiacolate is exempted from the 
requirement of a tolerance when used as a plant growth regulator in 
end-use products at a concentration of 0.1% by weight and applied at an 
application rate of 20 g of a.i. per acre or less per application, in 
or on all food commodities.


Sec. 180.1140  Sodium o-nitrophenolate; exemption from the requirement 
of a tolerance.

    The biochemical sodium o-nitrophenolate is exempted from the 
requirement of a tolerance when used as a plant growth regulator in 
end-use products at a concentration of 0.2% by weight and applied at an 
application rate of 20 g of a.i. per acre or less per application, in 
or on all food commodities.


Sec. 180.1141  Sodium p-nitrophenolate; exemption from the requirement 
of a tolerance.

    The biochemical sodium p-nitrophenolate is exempted from the 
requirement of a tolerance when used as a plant growth regulator in 
end-use product at a concentration of 0.3% by weight and applied at an 
application rate of 20 g of a.i. per acre or less per application, in 
or on all food commodities.

[FR Doc. 00-28277 Filed 11-2-00; 8:45 am]
BILLING CODE 6560-50-S