Prop 65 Proposed Changes to Calculating Exposure to Reproductive Chemicals in Food

(OEHHA) has proposed changes to the regulations that govern how Prop 65 reproductive toxicants in foods should be calculated. The proposed changes to the Prop 65 regulations amend 27 CCR §25821(a) and 27 CCR §25821(c) (2) purportedly to prevent incorrect or inconsistent determinations as to the applicability of Prop 65.  https://oehha.ca.gov/proposition-65/crnr/proposed-amendment-sections-25821a-and-c-level-exposure-chemicals-causing.

§ 25821. Level of Exposure to Chemicals Causing Reproductive Toxicity

(a) For purposes of the Act, “level in question” means the chemical concentration of a listed chemical for the exposure in question.  The exposure in question includes the exposure for which the person in the course of doing business is responsible, and does not include exposure to a listed chemical from any other source or product.  For purposes of this section, where a business presents evidence fo r the “level in qu e stio n ”   of a listed chemical in a food product based on the average of multiple samples of that food, the level in question may not be calculated by averaging the concentration of the chemical in food products from different manufacturers or producers, or that were manufactured in different manufacturing facilities from the product at issue.

This proposed rule bars a producer from calculating an average exposure level from multiple samples based on food from different manufacturers or producers or from different manufacturing facilities. OEHHA stated that they believe  that it is inconsistent with the purposes of [Prop. 65] to average concentrations of chemicals in products manufactured over extended periods, and “based on concentrations measured in samples of foods from different manufacturers or producers, or from different manufacturing facilities, because these are not necessarily representative of the levels of the chemical in products an individual would typically be exposed to when consuming a particular product in California.” Initial Statement of Reasons https://oehha.ca.gov/media/downloads/crnr/isor25821100518.pdf at p.9.

OEHHA also made proposed changes to the way the rate of intake or exposure is calculated:

§ 25821.(c)(2) For exposures to consumer products, the level of exposure shall be calculated using the reasonably anticipated rate of intake or exposure for average users of the consumer product, and not on a per capita basis for the general population.  This rate of intake or exposure is calculated as the arithmetic mean of the rate of intake or exposure for users of the product. The rate of intake or exposure shall be based on data for use of a general category or categories of consumer products, such as the United States Department of Agriculture Home Economic Research Report, Foods Commonly Eaten by Individuals: Amount Per Day and Per Eating Occasion, where such data are available.

In this section 27 CCR § 25821(c)(2), OEHHA  attempts to define  the method of calculating  the reasonably anticipated rate of intake  by using the arithmetic mean of differing exposure rates. According to OEHHA the arithmetic mean best captures that variability because it, unlike a geometric mean or median methodology it “accounts for consumption levels at both the low and the high end of the range, weighing the intake of each consumer equally.” Initial Statement of Reasons at p.8.

These amendments would arguably abrogate the state appellate court decision in Environmental Law Foundation v. Beech-Nut Nutrition. et al., (2015) 235 Cal.App.4th 307, (“Beech-Nut”) in which the Court allowed exposure calculations based on the average lead levels across different manufacturers and facilities. It also permitted the use of the geometric mean to calculate rates of rather than the arithmetic as these proposed rules require.

OEHHA in the Initial Statement or Reasons makes it clear that they believe that the Court in Beech-Nut was wrong:

Neither [of the Court] finding[s]  is consistent with the intent of OEHHA’s regulations or Proposition 65, which is focused on an individual exposure from a specific product. Therefore, OEHHA believes that the regulations should be clarified so that businesses and courts can apply the correct analysis in the future. It should be noted that it is also inconsistent with the purposes of the Act to average concentrations of chemicals in products manufactured over extended periods. OEHHA considered including a time element in this regulation. Initial Statement of Reasons at p.11

The consequence of these new rules would be to make it more difficult for food producers to support a decision to forego labeling certain food products, as  the proposed  rule makes the Prop 65 threshold more difficult to calculate because of  the inherent variability of constituents in foods with respect to the levels in the foods and the variability of  the rate of exposure to consumers.

 The Public comment cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.Public comments cutoff was extended until November 26, 2018 and with a public hearing that will be held on November 19, 2018.

Proposed Proposition 65 Regulation Concerning Chemicals in Coffee

OEHHA has initiated a proposed regulation to attempt to clarify that exposures to Proposition 65 listed chemicals in coffee are created by the roasting of coffee beans and brewing of coffee and the State asserts that it does not pose a significant cancer risk.  

The proposed language is as follows:


              ARTICLE 7. NO SIGNIFICANT RISK LEVELS § 25704. 

        Exposures to Listed  Chemicals in Coffee Posing No                                              Significant Risk

       Exposures to listed chemicals in coffee created                               by and inherent in the processes of roasting                                     coffee  beans or brewing coffee do not pose a significant               risk of cancer. 

NOTE: Authority cited: Section 25249.12, Health and Safety Code. Reference: Sections 25249.6 and 25249.10, Health and Safety Code

 A public hearing on the proposed rule making is scheduled for August 16, 2018 at 10 am in the CalEPA Headquarters Building, 1001 I Street, Sacramento.  A public-comment period on the proposed rule making will close on August 30, 2018.

FDA Discretionary Enforcement under FSMA

 The FDA announced in  early January that the agency would be using its discretion not to enforce certain of the rules promulgated under the Food Safety Modernization Act the as they apply to specific entities or activities.  The enforcement discretion applies to provisions in the : Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals rule Foreign Supplier Verification Programs Rule, and Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.  The discretion relates to facilities impacted by the confusion under the definition of "Farms;" written assurance provisions in the  rules concerning  the control of identified hazards or microorganisms that could be a risk to public health. Their discretion will also be applied to animal food preventive controls  for certain manufacturing/processing activities performed on human food by-products that are to be used as animal food; and initially as to the verification requirements for importers of food contact substances.

 Food Safety Concerns Top Ten for 2017

Posted by Lee N. Smith


These are the Top Ten Food Safety Concerns for 2017 that were identified by the Acheson Group:

1. Trump's New Administration:What changes will occur  What will the new administration do with the FDA budget and how will that impact its FSMA enforcement resources? It will also be interesting to see if any change is made in the overall direction and function required of FDA – particularly as there is now a food industry representative in the upper echelons, with the appointment of Hardee's/Carl's Jr. CEO Andrew Puzder as Labor Secretary. We don’t expect any dramatic and sudden changes with either FDA or FSIS, but over time there may be a change in enforcement strategy.
2. FDA Inspections: We can expect to see FDA inspectors facing a continued learning curve as they begin inspections of FDA regulated facilities against the new FSMA regulations. That said, we would expect the number of large facilities inspected to increase over the course of the year. So, while all food facilities should be prepared for an unannounced FDA visit, large companies should be particularly prepared with their food safety plans in place and know that FDA could stop by at any time. So be ready to answer that question from FDA: “Show me your food safety plan.”
3. Focus on Environmental Controls and Increased Recalls: With FDA inspectors inspecting facilities to FSMA rules and conducting environmental sampling/swabbing and use of PulseNet, they are likely to discover issues that will bring food safety into question. This could be due to any number of reasons, such as incomplete records, questionable environmental monitoring programs, failure to administer proper preventive controls, inadequate training, failure to follow GMPs, etc. As these issues are uncovered, FDA may request specific time frames for manufactured food to be recalled out of an abundance of caution. With the pressure of FSMA and compliance, it is also likely that voluntary recalls will increase, with companies pushing hard to be better educated on risks within their facilities and more. Facilities that are diligent and proactive will be able to detect and correct issues – before a third-party auditor or surprise FDA inspection finds (and cites) them. A key message for 2017 is to make sure you have done the best you can with your environmental control program, especially if you make ready-to-eat foods.
4. Second Round of Compliance: With the next round of extended compliance dates now coming due, small companies and pet food manufacturers will have to be FSMA-compliant in 2017. These two sectors will be ramping up their food safety plans just as the large companies did in 2016, so we can expect to see a mirror effect as they implement their food safety plans.
5. Dedicated PCQI Positions: As companies develop and implement their food safety plans, they are becoming very aware of the numerous duties and responsibilities of the Preventive Controls Qualified Individual. With these added responsibilities potentially requiring full-time or contract personnel, depending on the size of the food company and/or complexity of the manufacture of the food product, companies will need to be taking this into consideration and potentially making additional hires or reassessing existing roles.
6. More Pressure on Suppliers: Food manufacturers and processors depend on suppliers to provide safe ingredients both to ensure the end safety of their products and to fulfill FSMA rules. Thus, suppliers will be scrutinized for complete, thorough and accurate information, followed by increased verification by the food companies. Third-party verification will increase, and the qualifications of the third party will be further scrutinized.
7. A Continued Request for Clarification: As more food industries become compliant with FSMA, the number of questions submitted to the FSMA Technical Assistance Network (TAN) will continue. Industry trade groups will continue to solicit information and clarification from FDA on specific interpretations of FSMA and how it applies to their niche, and will look for continued guidance updates.
8. GMO Foods: Beyond FSMA, we can expect to see a continued focus on the regulation/labeling of GMO foods. Although USDA has two years to develop the program, consumers are unlikely to let the matter drop completely, particularly as the drive for natural and "free-from" foods grows and consumers make their voices are heard.
9. Social Media: We fully expect social media will continue to play a role in numerous ways – and likely in an area that hasn't yet been addressed, though we'd need a crystal ball to be able to say just what that might be. But as more and more people become actively engage in social media, the spread of information -- and misinformation -- will only increase in volume and speed, so food companies will need to be prepared to react properly and efficiently and continue to develop ways to figure out what social media is saying about your brand before it becomes a crisis.
10. Changing World Views: As 2016 came to an end and the Trump Administration began putting forward its plans, a push and pull of globalization vs. economic nationalism began to show its face. And this is just one of the ways in which the world seems to be unsettled in ways that we've not seen before. It is much bigger than food, but is highly likely to impact the food industry in some way – or many.

Telone Lawsuit Filed

by. Lee N.Smith

Attorneys representing a Ventura County farmworker and environmental justice groups filed a lawsuit against the California Department of Pesticide Regulation (DPR) in January 2017 alleging that the California state agency did not do enough to protect the public from the fumigant pesticide Telone (1,3-dichloropropene).  The lawsuit, filed in Alameda County Superior Court, alleges that DPR failed to follow the recommendations of scientists, and failed to provide public review for the regulation of the chemical. also known as   Specifically, the lawsuit first charges that DPR did not follow normal public procedures in developing new rules for Telone. This includes giving public notice and allowing the public an opportunity to comment.  The suit also alleges that DPR did not base its regulations on the advice of scientists at the Office of Environmental Health Hazard Assessment (OEHHA), and is in violation of a state law that requires the agencies to work together in crafting regulations, said Mark Weller, a spokesman for Californians for Pesticide Reform.  Banned for agricultural use in the European Union since 2011, as well as in California between 1990 and 1995, Telone is the third most used pesticide in California by pounds and the second most used “pesticide of public health concern” near public schools.   Telone is injected into the soil to kill pests before planting. Pesticide opponents say it drifts for days after and miles away from its application.  

New Prop 65 Regulations have Been Approved

In August 2016 OEHHA finalized the new Prop 65 Warning regulations.

• In summary, there is new safe harbor language, a new website for consumers, and attempts to clarify liability as between manufacturers and retailers. The new regulations go into effect on August 30, 2018, new labels can however be used before that time. The language required by Consent Judgments is considered within safe harbor. The new labels contain language that requires the identification of at least one of the Proposition 65 chemicals in the product.The language for each of the types of warnings (i.e. environmental vs. product) has changed.
• The emphasis is for liability to the manufacturer; along with additional duties toward vendors.
• There is new web Proposition 65 site sponsored by OEHHA.
• There are new symbols required on the safe harbor labels.
• Manufacturer/Retail Seller Responsibilities
  • Product manufacturers have primary responsibility for warning.
  • Manufacturer can label product or provide notice to distributor/importer/retail seller that a product may cause an exposure to a listed chemical.
  • Provide warning signs, materials (unless they make other arrangements via contract).
    • Retail sellers confirm receipt of notice act as “pass-through” for warning.
  • Provide non-English language warnings in certain situations.
  • Safe Harbor Content and Methods
• “This product contains….”
  • “This product can expose you to….”
  • The name of at least one chemical in the warning.
  • Warning required for chemicals A and B.  Business can include the name of A or B, or both.
  • Named chemicals are those for which warning is being provided.
  • Business selects which chemical(s) to include in warning.
  • Answers question: “What am I being exposed to?”
  • OEHHA web site URL
  • Warning symbol

• Phase In:
• Two-year phase-in period.
• Effective date of regulation: August 30, 2018.
• Consumer products manufactured prior to the effective date will not require new warnings if they meet existing safe harbor requirements.
• Court-approved warnings expressly recognized and considered “clear and reasonable” for parties to litigation.
• Tailored Warnings; in addition to the specific warnings listed above, the code has modified the warnings for the following categories:
• Environmental Exposure
• Occupational Exposure
• Specific Product, Chemical and Area Exposure Warnings
• Food
• Alcoholic Beverages
• Food and Non-Alcoholic Beverages
• Prescription Drug Exposure and Emergency Medical or Dental Care Exposure
• Dental Care
• Raw Wood Products
• Furniture Products
• Diesel Engines
• Vehicles
• Recreational Vessels
• Enclosed Parking Facilities
• Amusement Parks
• Petroleum Products
• Service Station and Vehicle Repair
• Designated Smoking Areas

Prop 65: Acrylamide in your Coffee ? Court Issues Tentative Order

by Lee N. Smith  In a case that has been widely watched, a Central Los Angeles Superior Court has issued a tentative ruling in the Phase One portion of a case that was originally filed against coffee purveyors, alleging that the acrylamide levels in their coffee products exceed the Prop 65 levels that require warnings.  Acrylamide is an interesting chemical as many times it is created when the product is cooked or prepared rather than contained in volume in the original product. One of the original Prop 65 cases involved whether potatoes and subsequent products were regulated under Prop 65 as the acrylamide was generated during cooking.

The case CERT v. Starbucks BC 435759 expanded to include a larger group of manufacturers and retailers. Phase I of the case was to address three issues. The first issue was whether the products created a significant risk of cancer, the second and third issues were whether there was first amendment right, or federal preemption issues that govern Prop 65 labels. The last two issues have been unsuccessfully argued in the past.

In this case the court has tentatively found that the defendants have not proven that the levels in their products are below the threshold and therefore do not present a significant risk of cancer. Defendants argued that the coffee as a whole, including a myriad of other chemical was not a cancer risk. The Court disagreed and defendants have until July 16 to finalize any objection to his conclusion. The phase II portion of the case then relates to whether any Proposition 65 labelling requirements were violated. The Court also found against defendants on the other two issues as well.