Toxicology Forum

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Toxicology Forum

• Acrylamide in Food A Progress Report
• (Panel Presentation)
• Carol J. Monahan, Chief Counsel
• California Environmental Protection Agency
• Office of Environmental Health Hazard Assessment
• July 11, 2005

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Proposition 65

• Right-to-Know Law (California Only)
• Requires a Clear and Reasonable warning for
  exposures to carcinogens or reproductive toxins
• Does not establish regulatory limits for
  chemicals in foods or other products
• Does establish threshold levels that trigger
  the warning requirement

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The Acrylamide Work Plan

• OEHHAs response to emerging acrylamide-related
  issues and requests for action by Food Industry
  Coalition
• New round of 60-Day notices filed in June 2005

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Evolution of OEHHAs Acrylamide Work Plan

• January 1990 - Acrylamide listed
• NSRL set at 0.2 mg/Day
• April 2002 Swedish study finds high levels of
  acrylamide in fried and baked foods
• Litigation filed in September 2003 against Burger
  King and McDonalds Corporations
• WHO, FDA, OEHHA begin considering action

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Evolution of Work Plan (cont.)

• Industry requests specific actions by OEHHA
• May 2003 - OEHHA holds workshop
• October 2003, OEHHA issues draft work plan,
  requests public input, and presents draft work
  plan to CIC for advice and consultation
• March 2004, Final Work Plan issued by OEHHA

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Evolution of Work Plan (cont.)

• April 2005, OEHHA announces three proposed
  regulations and a workshop for an additional
  action
• June 2005, new round of 60-day notices filed

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Proposed Regulations

• Update of NSRL
• Alternative risk level for breads and cereals
• Point-of-Sale warning notice for acrylamide in
  foods

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NSRL Update

• Reviewed currently available scientific
  literature
• Bioassay/Biomarker/Pharmacokinetic studies
• CIC and public comments
• Information presented at JIFSAN meeting
• Proposal is to change the NSRL to 1.0 mg/Day

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Alternative Risk Level

• Allowed by regulations where public health
  considerations warrant
• Based on FDA input concerning the necessity for a
  balanced diet to include breads and cereals
• Proposed Alternative Risk Level for breads and
  cereals is 200 parts per billion or less

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Proposed Warning Language for Acrylamide in Foods

• Point-of-Sale option
• More balanced and informative than existing
  warning language
• References to FDA advice

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Timeline for Regulatory Actions

• Draft regulations published April 2005
• Comment period closed June 24
• Reviewing and preparing response to comments
• Final regulations anticipated early 2006

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Other Potential Action

• Workshop held May 9, 2005, to discuss potential
  regulatory action to exempt chemicals formed from
  natural constituents in foods during cooking
• No regulation has been proposed
• Comment period closed June 10

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Other Potential Action (cont.)

• Reviewing comments and considering next steps
• Decision concerning proposal anticipated this
  summer

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For More Information

• www.oehha.ca.gov/prop65/acrylamide.html
• Carol Monahan, Chief Counsel
• [phone] or cmonahan_at_oehha.ca.gov

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Questions?
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