California’s OEHHA proposed modified regulation on warnings for chemicals formed during cooking

OEHHA originally proposed the new regulation back in August 2020, which was intended to provide that intake of chemicals formed during cooking does not represent an exposure for the purposes of Proposition 65 if their levels in food are reduced to the lowest level currently feasible using appropriate quality control measures.¹ Regarding acrylamide in particular, subsection (d) of the proposed regulation also sets forth the maximum concentration levels for acrylamide in certain foods that are considered currently feasible by OEHHA.  A total of 25 public comments were submitted to OEHHA following the publication of the original proposed regulation.² After reviewing these comments, OEHHA modified the language of the new regulation as follows:

• The last sentence in subsection (a) was removed to clarify that a business is not required to make any further showing of feasibility or compliance with good manufacturing practices to rely on the levels established in subsection (d). 

• The change to subsection (b) would replace the phrase “in the course of doing business,” with the phrase “otherwise responsible for an exposure to a listed chemical in a food" for clarity.

• Also, in subsection (b) the phrase “that is different from the concentrations provided in subdivision (d)” is added for purposes of clarity.

• In subsection (d)(1), the reference to roasted almond butter and prune juice was removed for further review and possible inclusion in a future rulemaking.

Apart from removing roasted almond butter and prune juice from subsection (d), OEHHA has modified the language in subsections (a) and (b) in such a way that, if the modified language is adopted, food manufacturers would have the flexibility to use evidence, standards, risk assessment methodologies, principles, assumptions, or levels described in Articles 7 and 8 to establish an alternative concentration for a listed chemical that is different from those specified in the table in subsection (d).

Modified Proposed Regulation

The modifications to the proposed regulation provided by OEHHA in underline and strikeout format are copied below.

27 CCR § 25505

§ 25505. Exposures to Listed Chemicals in Cooked or Heat Processed Foods.

1. A person otherwise responsible for an exposure to a listed chemical in a food does not “expose” an individual within the meaning of Section 25249.6 of the Act, to the extent the chemical was created by cooking or other heat processing if the producer, manufacturer, distributor, or holder of the food has utilized quality control measures that reduce the chemical to the lowest level currently feasible.  If a person does not reduce the level of the chemical in a food to the lowest level currently feasible, the resulting exposure must be calculated without regard to the levels set out in subsection (d).

2. Nothing in this section shall preclude a person in the course of doing business otherwise responsible for an exposure to a listed chemical in a food from using evidence, standards, risk assessment methodologies, principles, assumptions, or levels described in Articles 7 and 8 to establish an alternative concentration for a listed chemical in a food that is created by cooking or other heat processing that is different from the concentrations provided in subdivision (d).

3. Nothing in this section shall apply to parties to an existing court-ordered settlement or final judgment to the extent that such settlement or judgment establishes a concentration of the chemical in a specific product covered in the settlement or judgment.

4. The concentration levels for chemicals in foods in this subsection are deemed to comply with subsection (a).  In this subsection, ‘average concentration’ refers to the average of concentrations measured in multiple items or individual packaging units of the specific food product in the form the product is sold to California consumers.  The unit concentration is the concentration measured in a single food item or individual packaging unit of the specific food product in the form the product is sold to California consumers.

(1) Acrylamide

Next Steps

Once finalized, the new regulation has the potential to significantly impact the warning requirements for acrylamide and other listed chemicals formed during the cooking of food.  We will continue to monitor all regulatory actions related to Proposition  65.  Please contact us if you have any questions.

References

1 OEHHA, “ Notice of Modification of Text Proposed Amendments to Article 5 Section 25505 Exposures to Listed Chemicals in Cooked or Heat Processed Foods,” available at: Notice of Modification of Text Proposed Amendments to Article 5 Section 25505 Exposures to Listed Chemicals in Cooked or Heat Processed Foods | OEHHA (accessed on April 19, 2021); OEHHA, “Notice Of Proposed Rulemaking Adoption to Section 25505 Exposures to Listed Chemicals in Cooked or Heat Processed Foods,” available at: Notice Of Proposed Rulemaking Adoption to Section 25505 Exposures to Listed Chemicals in Cooked or Heat Processed Foods | OEHHA (accessed on April 19, 2021).

2 OEHHA, “ Comment Submissions - Notice Of Proposed Rulemaking Adoption to Section 25505 Exposures to Listed Chemicals in Cooked or Heat Processed Foods,” available at: Comment Submissions - Notice Of Proposed Rulemaking Adoption to Section 25505 Exposures to Listed Chemicals in Cooked or Heat Processed Foods | OEHHA (accessed on April 19, 2021).

Authored by Martin J. Hahn, Xin Tao, and Mary B. Lancaster