[Federal Register Volume 65, Number 226 (Wednesday, November 22, 2000)]
[Notices]
[Pages 70352-70354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29895]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00674; FRL-6736-9]


Pesticides; Elimination of 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 seeks public comment on a draft Pesticide 
Registration (PR) Notice titled ``Elimination of Phenol Resistance 
Testing for Antimicrobial Disinfectant and Sanitizer Pesticides.'' This 
draft notice provides guidance to registrants concerning the 
discontinuation of phenol resistance testing as a part of efficacy 
testing for antimicrobial disinfectants and sanitizers.

DATES:  Comments, identified by docket control number OPP-00674, must 
be received on or before January 8, 2001.

ADDRESSES:  Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the SUPPLEMENTARY INFORMATION. To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00674 in the subject line on the first page of your 
response.

FOR FURTHER INFORMATION CONTACT:  Ibrahim Barsoum, Antimicrobials 
Division (7510C), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460; telephone number: (703) 308-6417; 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. Potentially affected categories and entities 
may include, but are not limited to:

[[Page 70353]]



------------------------------------------------------------------------
                                                          Examples of
           Categories                    NAICS            potentially
                                                      affected  entities
------------------------------------------------------------------------
Pesticide Producers               32532               Pesticide
                                                       manufacturers
                                                      Pesticide
                                                       formulators
------------------------------------------------------------------------

    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 and the PR Notice 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 draft 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 6132. 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-00674. 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 holidays. The 
PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00674 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information and Records Integrity Branch (PIRIB), Information Resources 
and Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The 
PIRIB telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
E-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in Wordperfect 6.1/
8.0 file format or ASCII file format. All comments in electronic form 
must be identified by docket control number OPP-00674. Electronic 
comments may also be filed online at many Federal Depository Libraries.

D. How Should I Handle CBI That I Want to Submit to the Agency?

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA in response to 
this document as CBI 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under FOR FURTHER INFORMATION 
CONTACT.

E. What Should I Consider as I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used 
that support your views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the notice.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. To ensure proper receipt by EPA, be sure to identify the docket 
control number assigned to this action in the subject line on the first 
page of your response. You may also provide the name, date, and Federal 
Register citation.

II. Background

A. What Guidance Does this PR Notice Provide?

    The draft PR Notice announces the discontinuation of phenol 
resistance testing as a part of efficacy testing for antimicrobial 
disinfectants and sanitizers. When the PR Notice is issued in final 
form, the Agency will 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 then 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

[[Page 70354]]

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 
questions 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 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 and 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 will no longer require 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 generally will expect 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 draft 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 or not applicable to a 
specific pesticide or situation.

List of Subjects

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


    Dated: November 9, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.

[FR Doc. 00-29895 Filed 11-21-00 8:45 a.m.]
BILLING CODE 6560-50-S