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Antimicrobial Science Policies
Disinfectant Technical Science Section (DIS/TSS)
Each of the "DIS/TSS" guidance documents listed below provides
a summary of current efficacy-related requirements and/or policy for a
category of antimicrobial pesticide products, claims, or patterns of use.
If more detailed guidance is needed, the Antimicrobials Division should
be consulted ("DIS/TSS" is the acronym for Disinfectant Technical
Science Section, the Antimicrobials Division's former Efficacy Evaluation
Team).
If any of the product's use patterns is classified as human health related
(see DIS/TSS-16), efficacy data must be submitted for review in order
to support the inclusion of that use pattern in the product registration.
Regardless of the use pattern, however, product efficacy data is required
to be maintained in the registrant's files.
The documents may be grouped as follows:
I. Initial review and label evaluation: DIS/TSS-15, 16
II. Efficacy data requirements: DIS/TSS-1, 2, 3, 4, 6, 7, 8, 9, 10, 12,
13, 14
III. Confirmatory efficacy requirements: DIS/TSS-5
The first group helps define the intended pattern of use for a product
(for those intended for use on hard surfaces) and helps determine if efficacy
testing is required to be submitted. These are in large part dependent
on the efficacy claims and directions for use on the product label. It
is necessary for these facts to be established before further discussion
of efficacy data requirements can be meaningful.
The second group of documents contains efficacy data requirements to
support efficacy claims (e.g., levels of antimicrobial activity, types
of microorganisms) and specific types of products or patterns of use (e.g.,
one-step' disinfectant/cleaner, food-contact surface sanitizer).
Before these requirements can be applied to a product, the intended claims
and use patterns must be known (at least in a general way). Standard test
methods are intended to support standard' claims or use patterns;
for other claims and uses, modified methodology may be necessary. Therefore,
adequate use directions on the proposed product label are necessary for
a specific determination of efficacy testing requirements. In addition,
the efficacy testing and reporting must include all elements necessary
for evaluating the methodology employed and the results obtained (see
DIS/TSS-2 and -3).
The third group of documents contains confirmatory data requirements.
These documents should be used only after the Agency has determined that
minimal, confirmatory data is applicable and appropriate for the product
in question. Such a determination involves comparison of formulations
and manufacturing procedures, adequacy of referenced basic efficacy data,
and conformity of claims and directions for use with current labeling
requirements. Once confirmatory' data is determined appropriate
for the product in question, it may be submitted as a supplement to the
referenced basic' data.
Number
|
Title
|
Date
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DIS-TSS
01 |
Disinfectants for Use on Hard Surfaces |
Jan. 22, 1982 |
DIS-TSS
02 |
Supplemental Recommendations |
Jan. 25, 1979 |
DIS-TSS
03 |
Reporting of Data |
Jan. 29, 1979 |
DIS-TSS
04 |
Sanitizing Rinses for Previously Cleaned Food-contacted
surfaces |
Jan. 30, 1979 |
DIS-TSS
05 |
Confirmatory Efficacy Data Requirements |
Sept. 22, 1982 |
DIS-TSS
06 |
Supplemental Efficacy |
|
DIS-TSS
07 |
Virucides ( Test
Results Table) |
Nov. 12, 1981 |
DIS-TSS
08 |
Carpet Sanitizers |
Apr. 18, 1981 |
DIS-TSS
09 |
Sterilizers |
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DIS-TSS
10 |
Sanitizer Test for Inanimate Surfaces |
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DIS-TSS
11 |
Air Sanitizers |
Sept. 3, 1980 |
DIS-TSS
12 |
Swimming Pool Water Disinfectants |
Apr. 23, 1979 |
DIS-TSS
13 |
Laundry Additives - Disinfection and Sanitization |
Apr. 4, 1980 |
DIS-TSS
14 |
Laundry Additives - Residual Self-Sanitization |
July 29, 1981 |
DIS-TSS
15 |
Label Requirements for Antimicrobial Pesticides Used
On Hard Surfaces |
Mar. 24, 1981 |
DIS-TSS
16 |
Determination of Health- Related and Non-Health-Related
Uses |
Jun. 26, 1979 |
DIS-TSS
17 |
Label Requirements for Pesticides Used for Sanitation
of Food Contact Surfaces |
Dec. 2, 1979 |
DIS-TSS
18 |
Label Requirements for Farm Premise Disinfectants |
Jan. 17, 1989 |
DIS-TSS
19 |
Label Requirements for Poultry House Disinfectants |
Jan. 17, 1980 |
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