[Federal Register Volume 66, Number 204 (Monday, October 22, 2001)]
[Rules and Regulations]
[Pages 53342-53346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-26533]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[OPP-301056; FRL-6745-6]
RIN 2070-AB78


Pseudomonas Chlororaphis Strain 63-28; 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 Pseudomonas chlororaphis Strain 63-
28 in or on all food commodities. Agrium US, Inc. 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 Pseudomonas chlororaphis Strain 63-28.

DATES: This regulation is effective October 22, 2001. Objections and 
requests for hearings, identified by docket control number OPP-301056, 
must be received by EPA, on or before December 21, 2001.

ADDRESSES: Written objections and hearing requests may be submitted by 
mail, electronically, or in person. Please follow the detailed 
instructions for each method as provided in Unit IX. of the 
SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your 
objections and hearing requests must identify docket control number 
OPP-301056 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: Anne Ball, 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) 308-8717; and 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.

[[Page 53343]]

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/. A frequently updated electronic 
version of 40 CFR part 180 is available at http://www.access.gpo.gov/nara/cfr/cfrhtml_180/Title_40/40cfr180_00.html, a beta site currently 
under development.
    2. In person. The Agency has established an official record for 
this action under docket control number OPP-301056. 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 64478) (FRL-
6042-4), EPA issued a notice pursuant to section 408 of the FFDCA, 21 
U.S.C. 346a(d), as amended by the FQPA (Public Law 104-170) announcing 
the filing of a pesticide tolerance petition by Agrium US, Inc., 4582 
S. Ulster St., Suite 1400, Denver, CO 80237. This notice included a 
summary of the petition prepared by the petitioner Agrium US, Inc. On 
October 13, 1999 all of Agrium's data were transferred to Eco Soil 
Systems, Inc. 10740 Thornmint Rd., San Diego, CA 92127 and Eco Soil 
Systems, Inc. is still interested in seeking this exemption. There were 
no comments received in response to the notice of filing.
    The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of Pseudomonas chlororaphis Strain 63-28.

III. Risk Assessment

    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 tolerance 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 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.

IV. 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 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.
    Acute toxicity studies indicate that AtEze, the end-use product 
containing P. chlororaphis Strain 63-28 is a Toxicity Category IV 
substance. The acute oral toxicity of P. chlororaphis Strain 63-28 in 
rats is greater than 5,000 milligrams/kilogram of body weight or 
Toxicity Category IV. The LD50 for dermal toxicity of P. 
chlororaphis Strain 63-28 is considered to be > 2g/kg body weight or 
Toxicity Category IV. In an eye irritation study, six New Zealand White 
rabbits were treated with the product and all except one showed no 
ocular irritation with observations continuing for seven days after 
dosing. (Toxicity Category IV). In a toxicity/pathogenicity study, the 
product containing P. chlororaphis Strain 63-28 was tested following 
acute intravenous challenge in male and female rats. Intravenous 
administration of the viable test substance (TS) and killed test 
substance (KTS) was followed by measuring levels of viable microbes in 
sampled tissues and observing for signs of toxicity or pathogenicity. A 
sampling of organs for presence of P. chlororaphis showed that cells 
were present in lungs, spleen, kidneys, and livers of male and female 
rats, and in the blood, mesenteric lymph nodes and caecum of male rats 
on day 0 (i.e. the day of treatment with TS). In subsequent sampling, 
one female rat was found to harbor some viable P. chlororaphis in the 
kidney on day three. All other samples from all animals were negative 
(i.e., below the detection limit). This lack of detection of the test 
substance in TS treated rats after day 3 indicates a clearance of the 
organism from the animals to < 30 cfu/ml or per tissue. No toxic or 
pathogenic effects were attributable to the intravenous administration 
of P. chlororaphis Strain 63-28 to rats at 4.3  x  10\6\ cfu per 
animal. No effects were noted from application of the killed test 
substance (KTS).
    Tier II and III data as listed in 40 CFR 158.740(c) were not 
triggered because of P. chlororaphis Strain 63-28's ubiquity in nature, 
favorable toxicological data based on studies submitted, favorable 
toxicological history because there have been no reports of the 
organism in the literature as a pathogen of humans or any animals, and 
inconsequential exposure based on the proposed use. Review of the 
available toxicology data and literature submitted in support of 
registration indicates that sufficient information is available for 
characterization of the risks to humans. Therefore, EPA has concluded 
that products which contain P. chlororaphis Strain 63-28 are not likely 
to produce adverse effects on humans and the organism is generally 
considered non-pathogenic to humans.

V. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information

[[Page 53344]]

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

    P. chlororaphis Strain 63-28 is a non-toxic, non pathogenic 
bacterium which is ubiquitous in nature. The Agency has previously 
registered Pseudomonas strains (e.g. fluorescens) for use on many 
crops. These species are closely related but, unlike P. fluorescens, 
there are no reports of any negative pathogenic effects on humans or on 
other animals by P. chlororaphis.
    1. Food. Review of the available toxicology data submitted in 
support of registration indicated that sufficient information is 
available to allow for characterization of the risks to humans. 
Products which contain P. chlororaphis Strain 63-28 are not likely to 
produce adverse effects on humans via their food since the organism is 
generally considered as non-toxic and non-pathogenic to humans.
    2. Drinking water exposure. There is no expected human exposure to 
the organism in drinking water from pesticidal use. Pesticide 
application for the only use currently proposed is limited to contained 
plants in greenhouses as a soil/potting mix drench for ornamental or 
vegetable crops. The proposed product label directs that for drip or 
trickle chemigation, the system must contain a functional check valve, 
vacuum relief valve, and low pressure drain to prevent water source 
contamination from back flow. Since the organism is non-toxic and non-
pathogenic to humans, even if small amounts would seep into the ground 
water, there would be no adverse effects on humans.

B. Other Non-Occupational Exposure

    P. chlororaphis Strain 63-28 is proposed for use on greenhouse 
grown vegetables and ornamentals. Exposures resulting from application 
to ornamentals is anticipated to be negligible because consumers will 
not be in contact with treated plants until after the foliage is dry 
when the number of bacteria present is greatly diminished compared to 
the amount that was applied. Leaf surfaces are nutrient poor and cannot 
support growth of the bacteria. Also, the bacteria are exposed to 
ultraviolet light and temperature extremes and are dried out in the 
greenhouse. Moisture is needed for growth of the bacteria. P. 
chlororaphis are common on plants and in soil and may be present in the 
absence of any application, but in relatively small amounts. Increase 
of the bacteria present through application of the pesticide is 
expected to be insignificant. No dermal or inhalation exposure is 
expected.

VI. Cumulative Effects

    P. chlororaphis Strain 63-28 does not share any common mechanisms 
of toxicity (metabolic mechanisms) with other substances. The use as a 
microbial pesticide should not significantly increase exposure to 
naturally occurring sources of P. chlororaphis Strain 63-28. 
Furthermore, the bacteria are not toxic or pathogenic for humans. 
Therefore, the potential for toxic effects or cumulative effects from 
the use of this pesticide is not expected.

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

    For the U.S. population, including infants and children, aggregate 
exposure to P. chlororaphis Strain 63-28 is expected to be minimal with 
no known adverse effects. As discussed previously, there is no 
potential for harm via dietary exposure since the bacteria is 
considered non-toxic and non-pathogenic to humans. There is a 
negligible exposure to consumers from other non-occupational sources; 
however, because the bacterium is non-toxic and non-pathologic to 
humans, no risk is foreseen. Moreover no dermal or inhalation exposure 
is expected. Therefore, EPA concludes that there is reasonable 
certainty that no harm will result to the U.S. population including 
infants and children, from aggregate exposure to residues of P. 
chlororaphis Strain 63-28 including all anticipated dietary exposures 
and all other exposures for which there is reliable information. The 
Agency has arrived at this conclusion because, as discussed above and 
throughout this document, no toxicity or pathogenicity to mammals has 
been observed for P. chlororaphis strain 63-28. Thus, a tolerance for 
P. chlororaphis Strain 63-28 is not necessary to protect the public 
health. Therefore, 40 CFR part 180 is amended as set forth below.

VIII. Other Considerations

A. Endocrine Disruptors

    EPA is required under 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 a scientific basis for including, as part of the program, the 
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 
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 Agency's Endocrine Disruptor Screening Program 
have been developed, P. chlororaphis Strain 63-28 may be subjected to 
additional screening and/or testing to better characterize effects 
related to endocrine disruption. Based on the weight of the evidence of 
available data, no endocrine system-related effects have been 
identified for P. chlororaphis Strain 63-28.

B. Analytical Method(s)

    The Agency proposes to establish an exemption from the requirement 
of a tolerance without any numerical limitation. Accordingly the Agency 
has concluded that analytical methods are not needed for enforcement 
purposes for residues of P. chlororaphis Strain 63-28.

C. Codex Maximum Residue Level

    There are no Codex Maximum Residue Levels nor any tolerances or 
exemptions issued for P. chororaphis Strain 63-28 outside the United 
States.

IX. 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.

[[Page 53345]]

 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-301056 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 December 
21, 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 IX.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 number OPP-301056, 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).

X. 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 (58 FR 51735, October 4, 
1993). Because this rule has been exempted from review under Executive 
Order 12866 due to its lack of significance, 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). 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 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); 
or OMB review or any Agency action under Executive Order 13045, 
entitled Protection of Children from Environmental Health Risks and 
Safety Risks (62 FR 19885, April 23, 1997). 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 
(64 FR 43255, August 10, 1999). Executive Order 13132 requires

[[Page 53346]]

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). For these same reasons, the Agency has 
determined that this rule does not have any ``tribal implications'' as 
described in Executive Order 13175, entitled Consultation and 
Coordination with Indian Tribal Governments (65 FR 67249, November 6, 
2000). Executive Order 13175, requires EPA to develop an accountable 
process to ensure ``meaningful and timely input by tribal officials in 
the development of regulatory policies that have tribal implications.'' 
``Policies that have tribal implications '' is defined in the Executive 
Order to include regulations that have ``substantial direct effects on 
one or more Indian tribes, on the relationship between the Federal 
government and the Indian tribes, or on the distribution of power and 
responsibilities between the Federal government and Indian tribes.'' 
This rule will not have substantial direct effects on tribal 
governments, on the relationship between the Federal government and 
Indian tribes, or on the distribution of power and responsibilities 
between the Federal government and Indian tribes, as specified in 
Executive Order 13175. Thus, Executive Order 13175 does not apply to 
this rule.

XI. 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 28, 2001.

James Jones,

Acting Director, 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), 346(a) and 371.


    2. Section 180.1212 is added to subpart D to read as follows:


Sec. 180.1212  Pseudomonas chlororaphis Strain 63-28; exemption from 
the requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the microbial pesticide Pseudomonas chlororaphis Strain 63-
28 in or on all food commodities.

[FR Doc. 01-26533 Filed 10-19-01]
BILLING CODE 6560-50-S