NSF Nonfood Compounds Steering Committee Meeting October 25, 2005 Antimicrobials in NSF Registered P

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NSF Nonfood Compounds Steering Committee
MeetingOctober 25, 2005Antimicrobials in NSF
Registered Products

• Jennifer De France
• Supervising Toxicologist
• NSF International

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Overview

• FIFRA and EPA/OPP Overview
• Treated Article Exemption
• NSF Guidelines and FIFRA Registration
• Jurisdiction of Antimicrobial H1 Lubricants

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Pesticide Regulation

• Federal Insecticide, Fungicide and Rodenticide
  Act
• Pesticides and products containing pesticides
  sold or distributed in the United States are
  regulated under this act
• Administered by the Environmental Protection
  Agency Office of
• Pesticide Programs (EPA OPP)

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What is a Pesticide

• 40 CFR 152.3
• Any substance or mixture of substances intended
  for preventing, destroying, repelling or
  mitigating any pest

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What is a Pest

• 40 CFR 152.5(d)
• Any fungus, bacterium, virus, or other
  microorganisms, except for those on or in living
  man or other living animals and those on or in
  processed food or processed animal feed,
• beverages, drugs and cosmetics

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FIFRA Registration

• The requirement of FIFRA registration can be
  determined by (40 CFR 152.15)
• The intended use of the product
• Purpose of the ingredients within the product
• Claims made about the product, including
  labeling claims

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Antimicrobial Claims

• Products making antimicrobial claims require EPA
  registration under FIFRA
• Kills germs that cause spoilage
• Bactericidal
• Products making preservative claims also require
  EPA registration under FIFRA unless the
  preservative is covered under the
• Treated Article Exemption

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Treated Article Exemption

• 40 CFR 152.25(a)
• The EPA exempts from FIFRA regulation any treated
  article if
• The sole purpose of the pesticide is to protect
  the article or substance itself, and
• The pesticide is registered for use in
• or on that article or substance
• (i.e. lubricants)

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Treated Article Exemption

• Preservative related claims
• Clarified under Pesticide Registration (PR)
  Notice 2000-1
• Must not be given greater prominence
• than other described product features
• Claims must be limited to the
• treatment to protect the product

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Treated Article Exemption

• Treated Article Exemption does not apply to
• Articles with public health claims
• Articles with surface activity claims other than
  odor or mildew control
• Articles that are treated with a preservative
  that is not specifically registered for the use
• These treated articles must be EPA registered

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NSF Registration

• NSF Registration Guidelines require that
  antimicrobial products meet FIFRA regulations
• NSF will confirm EPA Registration of products
  that fall under the FIFRA regulation

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NSF Registration

• The following NSF categories must be EPA
  registered
• D1 and D2 (Antimicrobial Products)
• F1 through F5 (Pesticides)
• Q3, Q4 and Q6 (Shell egg sanitizing products)

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NSF Registration

• Other NSF categories may need to be EPA
  registered
• Purpose of the ingredients within the product
• Claims made about the product and/or ingredients

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Jurisdiction of Antimicrobial H1 Lubricants

• Dual jurisdiction FDA and EPA
• The preservative or the lubricant must be EPA
  registered
• The preservative must be FDA approved

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Questions?