Disinfectants, Sanitizers, and Product Labeling

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Disinfectants, Sanitizers, and Product Labeling

• Overview of EPAs Antimicrobial Registration
  Process
• Women's Voices for the Earth Conference Call
• February 4th, 2009

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Disinfectant

• EPAs technical definition A substance, or
  mixture of substances that destroys or eliminates
  a specific species of infectious or public
  health microorganism, but not necessarily
  bacterial spores, in the inanimate environment.
  (OPPTS 810.2000 Guidelines)
• Disinfectant Claims 3 Main types / categories
• Limited Disinfectant effective against
  Staphylococcus aureus (ATCC 6538) or Salmonella
  enterica (ATCC 10708)
• Broad Spectrum, General Disinfectant effective
  against Staphylococcus aureus (ATCC 6538) and
  Salmonella enterica (ATCC 10708)
• Hospital / Medical Use Disinfectant effective
  against Staphylococcus aureus (ATCC 6538),
  Salmonella enterica (ATCC 10708), and Pseudomonas
  aeruginosa (ATCC 15442)
• Testing involves a complete killing of specific
  organisms in 59/60 carrier tubes for 3 product
  batches.
• May also carry claims for other bacteria,
  viruses, and fungi gt All public health /
  pathogenic organisms claimed on a product label
  are supported by data submitted to the Agency If
  treating blood-borne pathogens, this is the
  product type to use, assuming these organisms are
  present on the label

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Sanitizer

• EPAs technical definition A substance, or
  mixture of substances that reduces bacterial
  populations in the inanimate environment to
  levels considered safe as determined by Public
  Health Ordinance, or that reduces the bacterial
  population by significant numbers, but does not
  destroy or eliminate all bacteria. Sanitizers
  meeting Public Health Ordinance requirements are
  generally used on food contact surfaces and are
  recognized as sanitizing rinses. (OPPTS 810.2000
  Guidelines)
• Typically, these products have more dilute use
  concentrations and shorter contact times than
  disinfectants
• Two Main types
• Food Contact Sanitizers (Sanitizing Rinses)
• For use on surfaces which would contact food, no
  potable water rinse following application is
  allowed
• Testing of Salmonella typhi (ATCC 6539) or S.
  aureus (ATCC 6538) for halide products
  Escherichia coli (ATCC 11229) and S. aureus (ATCC
  6538) for non-halide products. Product
  demonstrates a 99.999 reduction over control in
  30 seconds (label claim of 1 min.) - suspension
  based test.
• Non-Food Contact Sanitizers
• For use on reducing numbers of bacteria on
  surfaces not in contact with food
• Testing of Staphylococcus aureus (ATCC 6538) and
  Klebsiella pneumoniae (ATCC 4352) or Enterobacter
  aerogenes (ATCC 13048). Product demonstrates a
  99.9 reduction in bacteria over control in 5
  minutes carrier based test.
• Sanitizers may not have claims for viruses or
  fungi
• Some products can be both a sanitizer and a
  disinfectant, depending on the label-specified
  concentration

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Regulatory Authority Process

• The Federal Insecticide, Fungicide, and
  Rodenticide Act (FIFRA), Section 3
• Data Review by Agency Scientists (40 CFR 152.107)
• Data on specific active ingredients (e.g.
  Exposure, Environmental Fate, Toxicity,
  Chemistry)
• Product-Specific Data
• Chemistry
• Acute Toxicity (dermal, oral, inhalation, etc.)
• Efficacy -gt What does it kill and at what
  concentration / contact time
• Process Simplified
• Applicants submit data, proposed product label,
  and other paperwork
• Application is reviewed by Agency scientists and
  regulators
• The product is then approved for sale, approved
  conditionally, or the applicant is asked to
  provide more data.
• The applicant may amend their registration at any
  time to add claims and/or uses to the label by
  submitting data or justification.

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Additional Information Not covered in
Introduction

• Product Labeling
• Key components to look for
• Organism claims
• Precautionary Labeling
• Web Links

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Product Labeling Key InfoKeep in mind, all
labeling language is important to read, but well
focus on a few components here.

• Registration Number Assigned by Agency
• EPA Reg. No. xxxx-xxx (Company - Product )
• May also have an Establishment EPA Est. _
• Area of Use - (Institutional use means any
  application of a pesticide in or around any
  property or facility that functions to provide a
  service to the general public or to public or
  private organizations, including but not limited
  to
• (1) Hospitals and nursing homes. (special data
  requirements)
• (2) Schools other than preschools and day care
  facilities.
• (3) Museums and libraries.
• (4) Sports facilities.
• (5) Office buildings. (40 CFR 152.3)
• Use Sites and Surfaces
• Hard, non-porous surfaces (e.g. floors, walls,
  countertops, etc.)
• Composition (e.g. stainless steel, sealed tile,
  plastic, etc.)
• Use of Personal Protective Equipment (PPE) If
  applicable

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Product Labeling Key Info

• Directions for Use (Read and Follow Carefully!!)
• Use Dilution
• Ready to use
• Add x oz. of product to x gallons of water
• Application
• Apply with a wet sponge, cloth, mop or coarse
  sprayer for example
• Contact Time
• Product only proven to be effective at this
  concentration and exposure time
• Crucial that surface stays wet for label
  indicated time, otherwise ineffective
• Post Application Instructions
• Let air dry
• Rinse food-contact surfaces with potable water
  (for disinfectant products with claims for
  food-contact surfaces)
• Remember, "It is a violation of Federal law to
  use this product in a manner inconsistent with
  its labeling."

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Product Labeling Organism Claims

• Example Effective against Methicillin
  Resistant Staphylococcus aureus on hard,
  non-porous surfaces
• Claims only allowed after supporting data
  submitted, reviewed, and accepted
• Specific to a contact time and use dilution
• Products have multiple organism claims
• Some organisms allow more general claims.
  Examples
• Mycobacterium bovis BCG ?Tuberculocidal
• Trichophyton mentagrophytes ? Fungicidal
• Any virus (an indicates which organism) ?
  Virucidal

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Product Labeling Precautionary Statements
(Signal Word)

• Designed to provide the pesticide user with
  information regarding the toxicity, irritation
  and sensitization hazards associated with the use
  of a pesticide, as well as treatment instructions
  and information to reduce exposure potential
• Signal word determined by the results of the six
  acute toxicity studies. (Below is an example of
  wording for oral exposure, also may be dermal
  (skin), inhalation, and eye exposure)

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Product Labeling Precautionary Statements

• If the products falls under Worker Protection
  Standards 40 CFR 170 and 40 CFR 156, Subpart K
  (156.200 - 212)
• PPE may be indicated for the user
• User Safety Recommendations may be present.
  Examples

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Resources

• Be sure to check state-specific pesticide
  guidelines and labeling!
• Regulating Antimicrobial Pesticides
  http//www.epa.gov/oppad001/index.htm
• Listing of products effective against selected
  pathogens http//www.epa.gov/oppad001/chemregindex
  .htm
• Non-EPA Antimicrobial Info Links
  http//www.epa.gov/oppad001/otherlinks.htm
• Locate labels for existing products using
  registration number http//oaspub.epa.gov/pestlabl
  /ppls.home
• For Further Questions on Registered Products
• Tidd.marcie_at_epa.gov