[Federal Register Volume 66, Number 126 (Friday, June 29, 2001)]
[Notices]
[Pages 34636-34637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16442]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00706; FRL-6771-9]


Pesticides; Guidance on Phenol Resistance Testing for 
Antimicrobial Disinfectant and Sanitizer Pesticides

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of availability.

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SUMMARY: The Agency is announcing the availability of guidance titled 
``Elimination of Phenol Resistance Testing for Antimicrobial 
Disinfectant and Sanitizer Pesticides.'' This final Pesticide 
Registration (PR) Notice provides guidance to registrants concerning 
the discontinuation of phenol resistance testing as a part of efficacy 
testing for antimicrobial disinfectants and sanitizers. Adoption of 
this guidance will eliminate unnecessary testing and will result in 
resource savings for both the Agency and registrants. Responses to 
public comments received in response to the previously issued draft 
guidance are also being made available.

FOR FURTHER INFORMATION CONTACT: Michele Wingfield, Antimicrobials 
Division, (7510C), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 308-6349; fax 
number: (703) 308-8481; e-mail address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    This action is directed to the public in general. Although this 
action may be of particular interest to those persons who manufacture 
or formulate pesticides. Since other entities may also be interested, 
the Agency has not attempted to describe all the specific entities that 
may be affected by this action. If you have any questions regarding the 
information in this notice, 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, the PR Notice, and the Agency's response to public comments 
from the Office of Pesticide Programs' Home Page at http://www.epa.gov/pesticides/. You can also go directly to the listings 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. Fax-on-demand. You may request a faxed copy of the Pesticide 
Registration (PR) Notice titled ``Elimination of Phenol Resistance 
Testing for Antimicrobial Disinfectant and Sanitizer Pesticides,'' by 
using a faxphone to call (202) 401-0527 and selecting item 6139. You 
may also follow the automated menu.
    3. In person. The Agency has established an official record for 
this action under docket control number OPP-00706. The official record 
consists of the documents specifically referenced in this action, any 
public comments received during an applicable comment period, 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 Highway, Arlington, VA, from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal

[[Page 34637]]

holidays. The PIRIB telephone number is (703) 305-5805.

II. Background

A. What Guidance Does this PR Notice Provide?

    The PR Notice announces the discontinuation of phenol resistance 
testing as a part of efficacy testing for antimicrobial disinfectants 
and sanitizers. The Agency will now consider registering or 
reregistering antimicrobial disinfectant or sanitizer pesticides 
without supporting phenol resistance testing. All other data in support 
of registration or reregistration, including any required efficacy 
testing data, would also need to be submitted and accepted by the 
Agency.
    Phenol resistance testing is a standard that has traditionally been 
used to estimate the intrinsic resistance or sensitivity of some test 
bacteria to chemical disinfectants and sanitizers. For years, the 
Agency has been aware of the lack of standard and uniform resistance 
levels to phenol expressed by the test cultures used in the existing 
Official Methods of Analysis of the Association of Official Analytical 
Chemists (AOAC) test methods. Historically, the inability to maintain 
and propagate test cultures that express standard and uniform levels of 
phenol resistance has been a recognized scientific problem which has 
persisted for at least 70 years. Furthermore, the inability of many 
reputable and competent testing facilities to achieve consistent test 
results with the phenol resistance standard has prompted both concern 
and action by the Agency.
    On September 10, 1997, after internal scientific deliberation, the 
Agency placed before the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA) Scientific Advisory Panel (SAP) the following 
question regarding phenol resistance:
    What scientific direction should be taken regarding the lack of 
standard and uniform resistance levels to phenol of the test cultures 
used in the existing AOAC (Association of Official Analytical Chemists) 
efficacy test methods? Should the Agency:
     Totally eliminate the phenol resistance requirement; or
     Modify the required phenol resistance patterns to provide 
a broader range of acceptable resistance; or
     Replace the phenol resistance requirements with some other 
procedures that assure hardiness and equivalence to test cultures, such 
as standard, quantitative inoculum level?
    Briefly, the SAP responded that there is no current relevance to 
requiring the phenol resistance test and, therefore, the phenol 
coefficient method should be eliminated and new protocols should be 
established for defining the conditions for culturing test 
microorganisms with suitable resistance levels to antimicrobials.
    Subdivision G of the Pesticide Assessment Guidelines, part 91-1, 
describes the general product performance (efficacy) standards for 
disinfectants and sanitizers. Subsection (b)(3)(I) of part 91-1 refers 
to the AOAC standard tests that may be used to satisfy the data 
requirements of 40 CFR 158.640. In turn, these AOAC tests include 
references to phenol resistance testing.
    The Agency concurs with the SAP, which has engaged in considerable 
discussion and deliberation, internally and with members of the 
scientific and regulated communities, on how to best proceed. Given the 
inapplicability of a test organism's resistance to phenol when 
disinfectants or sanitizers are tested for their efficacy performance, 
the Agency no longer requires submission of testing to demonstrate 
compliance with AOAC-specified levels of expressed phenol resistance by 
test microorganisms during the efficacy evaluation of disinfectants or 
sanitizers. However, as an interim measure while method development 
research continues, the Agency recommends a minimum inoculum level of 
104 colony forming units per carrier for all test 
microorganisms when the AOAC carrier based tests are used.

B. PR Notices are Guidance Documents

    The PR Notice discussed in this notice is intended to provide 
guidance to EPA personnel and decision-makers and to pesticide 
registrants. This notice is not binding on either EPA or pesticide 
registrants, and EPA may depart from the guidance where circumstances 
warrant and without prior notice. Likewise, pesticide registrants may 
assert that the guidance is not appropriate generally or not applicable 
to a specific pesticide or situation.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests.


    Dated: June 19, 2001.
Marcia E. Mulkey,
Director, Office of Pesticide Programs

[FR Doc. 01-16442 Filed 6-28-01; 8:45 am]
BILLING CODE 6560-50-S