Cynthia Oshita Office of Environmental Health Hazard Assessment Proposition 65 Implementation P.O. Box 4010 1001 I Street, 19th Floor Sacramento , California 95812-4010 RE: March 14, 2003 Notice to Interested Parties — Request for Information and for Public Input on Agenda for Acrylamide Workshop
Dear Ms. Oshita:
We welcome OEHHA’s plans to hold a workshop and to take action regarding the application of Proposition 65 to acrylamide from cooking and processing food. Urgent action on this issue is needed to prevent a mass of law suits and misleading warnings on foods that make up a significant part of our food supply – warnings which would not only misinform but could have serious adverse public health and economic consequences for Californians.
The United States Food and Drug Administration (“ FDA”) and other health and safety food agencies (collectively “Health Agencies”) are expending substantial resources on the completion of studies to determine whether acrylamide from cooking and processing presents any risk to the safety of the food supply. Thus far, they have found no reason to recommend a change in dietary habits. We urge OEHHA not to spend its scarce resources on duplicating these efforts, but rather to coordinate its work with these Health Agencies.
We encourage OEHHA to join the present consensus of Health Agencies in concluding that warnings or other recommendations regarding dietary habits, if any, should await the collection and evaluation of further information. It is appropriate and necessary for OEHHA, as the lead agency for Proposition 65 implementation, to take affirmative steps to clarify OEHHA’s concurrence with this consensus.
To this end, the workshop should focus on consideration of all regulatory options that will provide the immediate relief needed as well as consideration of potential longer term options. For options involving amendment of regulations, consideration should be given to enactment through the emergency rulemaking process. This approach will allow OEHHA the opportunity for review and coordination with FDA and other Health Agencies to determine whether in the future acrylamide in food from cooking and processing should be regulated under Proposition 65.
Background and Need for Immediate Action
When acrylamide was listed as a Proposition 65 chemical in 1990 and the Proposition 65 safe harbor regulations were adopted, acrylamide was known and regulated only as a synthetic chemical. In the past 12 months, scientists have learned for the first time that acrylamide is present in food and undoubtedly has been in the human food supply for thousands of years. We now know that when foods containing sugars or protein (as is true of most foods) are baked, broiled, grilled, fried or toasted, acrylamide is naturally produced. It is not surprising, therefore, that acrylamide has been detected in coffee, grilled asparagus and other vegetables, potato products, vegetarian burgers, bagels, bread, bread crumbs, toast, pizza crust, tortillas, breakfast cereals, almonds and other nuts, peanut butter, chocolate, baked beans, soups, macaroni and cheese, dips and onion rings, to name but a few. In fact, foods already identified by FDA as containing acrylamide as the result of heating account for approximately 40% of the energy consumed in the typical diet, and the list of such foods will continue to grow.
Acrylamide, we now know, has been a part of our food supply since our prehistoric ancestors discovered that cooking turns plant and animal matter into food. This is not an industrial phenomenon, but simply the natural result of cooking — whether in a food plant or a restaurant, at home or over the campfire. The one health study of acrylamide from cooking and processing published thus far (by the British Journal of Cancer ) found no increase in cancer rates associated with acrylamide intake for three likely target organs, colon, kidney and liver. Sir Paul Nurse, Chief Executive of Cancer Research UK, which published the study, suggested that an explanation for this result is that while “we know that acrylamide can be carcinogenic to animals, … this study suggests that either levels in food are too low to affect cancer risk, or that the body is able to deactivate the chemical in some way.” This new information on acrylamide suggests that there may be no scientific justification for the unqualified Proposition 65 listing of acrylamide and its existing safe harbor — both adopted before acrylamide was known to be present in food from cooking and processing. The work of FDA and the Health Agencies also makes clear that, based on current information, governments should not be encouraging a change in diet based on acrylamide. Rather, FDA and the Health Agencies should complete their work looking at, among other things, the body’s ability to deactivate the chemical, the toxicological significance of the levels found in food, and other factors relevant to determining whether acrylamide in foods poses any risk and, if so, how it should be managed. The FDA has prepared an Action Plan for Acrylamide in Food, and the work to complete the studies to determine whether acrylamide from cooking and processing presents any risk to the safety of the food supply is well under way at the FDA. In the meantime, immediate action is needed to prevent litigation and unfounded, counterproductive warnings that will needlessly scare the California public. Notwithstanding FDA’s advice, two Proposition 65 lawsuits involving six defendants already been filed – this, despite Attorney General Lockyer’s view that, in light of “the limited publicly available information at this time, Proposition 65 litigation against large numbers of food processors or sellers may not be appropriate or in the public interest.” These lawsuits effectively deprive OEHHA of its primary jurisdiction and deny the public the benefit of having these issues decided by regulatory agencies charged with protection of health and safety rather than by a patchwork of lawsuits among private litigants. Thus, prompt action by OEHHA is necessary to stop further litigation and to stay pending litigation while OEHHA completes its consideration of the issue. Otherwise, the threat of such lawsuits could lead to warnings on vast numbers of foods containing acrylamide, which would seriously misinform the public, harm the California economy (particularly the agricultural sector) and undermine Proposition 65. For example:
- California agricultural exports would be harmed if they bore warning labels, as would trade with Mexico .
- The cost of warnings on all acrylamide-containing products, approximately 40% of the items in a typical grocery store , would be monumental.
- Warning labels on so many commonly consumed foods would make consumers oblivious to warnings, undermining the effect of warnings about real hazards and subverting the intent of Proposition 65.
- Warning labels on cooked and processed foods containing acrylamide may cause consumers to buy uncooked (and therefore unlabeled) foods to cook at home, mistakenly believing them, to be safer because they are unlabeled.
- Consumers might otherwise try to avoid the warned of “risk” by avoiding cooked foods that are safe (resulting in dietary imbalance) or undercooking food, thereby failing to eliminate bacteria in certain raw foods.
Recommended Approach to the Workshop
Objectives. For all these reasons, we welcome the workshop as an opportunity to explore all options for dealing with this urgent situation. The workshop should focus on identifying a means of forestalling misleading warnings and preserving OEHHA’s jurisdiction while the studies of FDA and the other Health Agencies are completed, thereby providing OEHHA with a sound scientific basis for determining whether acrylamide in foods from cooking and processing poses a risk that warrants regulation under Proposition 65.
As a background for the workshop discussions, we urge OEHHA to invite representatives of FDA and JIFSAN to the workshop and, at the outset of the workshop, to explain the work the FDA and other Health Agencies have undertaken regarding acrylamide as well as any preliminary conclusions they have reached. Given OEHHA’s limited resources and its unique expertise, we believe it is important that OEHHA not embark on a course of action that involves needless and wasteful duplication of studies that are already underway. Nor should OEHHA, for these same reasons, seek to regulate broad issues of food health and safety regulation that go beyond the purview of Proposition 65, and which FDA and other agencies charged with this responsibility are already committed to resolving. Rather OEHHA should carry out its responsibility for implementing Proposition 65 by solving the immediate problem, and subsequently examining the further information that will guide a longer-term solution. Regulatory Options . We urge OEHHA to structure the workshop agenda to encourage identification and full consideration of all options that may provide the relief immediately needed, even if temporary, as well as consideration of potential longer term options. For options involving regulatory change, use of the emergency rulemaking process should be considered. Immediate Action . Separately, and in addition to its work on a regulatory solution, we urge OEHHA to issue a statement or take other appropriate action to make clear that warnings with respect to acrylamide in foods due to cooking and processing are not required and clarify to the courts and potential litigants that litigation with respect to such warnings should be stayed and no new litigation is appropriate, pending the conclusion of OEHHA’s ongoing proceeding to determine whether and in what manner acrylamide in food should be regulated under Proposition 65.
OEHHA should not seek to set alternative risk levels on a product category basis.
The task of identifying levels of acrylamide in specific products that are “acceptable” from a health standpoint and also “necessary” for proper cooking and palatability would present a substantial challenge for OEHHA, create an unmanageable situation for regulated entities, and almost certainly confuse consumers.
Quite apart from the questionable health benefits of such an approach, there is considerable doubt that such an approach is workable. It appears, for example, that the amount of acrylamide present in a particular product is a function of, among other things, the surface area for a given weight, the time of harvest, the time between harvest and cooking, differences in the strain of cocoa, coffee, potatoes and other produce, and the specific strain (as in the specific type of coffee or cocoa bean). Still further uncertainty may be introduced by variability in the test methods. FDA’s recently released exploratory data on acrylamide levels illustrate the issue. Looking simply at some of products FDA tested, the variations reported ranged greatly underscoring the need to look at acrylamide with a wider perspective than offered by a product-specific examination of “necessary” cooking. An overwhelming percentage of this variability cannot be attributed to cooking time or temperature, which suggests that precise regulation of acrylamide levels by product category or by product is, at best, impractical. Even acrylamide levels related to cooking time, such as the browning of toast, present vast impracticalities. The question of “How much browning of toast is ‘necessary’?” cannot be answered. The notion of basing an NSRL on cooking techniques or on the hope of changing these techniques is unrealistic for the additional reason that so many of these products — be they coffee, vegetables or potato products — are cooked at home as well as in food plants. Thus, one could easily wind up with an acrylamide warning on one commercially cooked food product and none on another when the amount of acrylamide the consumer actually is exposed to depends primarily on the purchaser’s at home preparation of the food. FDA has made two important comments about this exploratory data: The data generally do not address unit-to-unit variation or lot-to-lot variation. Also, differences in acrylamide levels between foods or even between brands at this early point in the survey do not necessarily indicate differences in exposure or potential risk that would be experienced by consumers. When estimating exposure and potential risk it is important to consider the amount of the food consumed and the day to day variation in levels, in addition to the level of acrylamide measured at a particular time. NSRLs set on a food category basis are, therefore, also almost certain to result in misleading and confusing information to consumers.
Options Recommended for Inclusion on Agenda
We recommend that all stakeholders and members of the public be invited to propose any options they believe will appropriately address the issues, whether submitted in advance, through comments such as these, or at the workshop. The options on the agenda for review at the workshop should include at least those listed below. Use of the emergency rulemaking process for implementation of options involving regulatory changes should also be considered.
Amend the listing of acrylamide so that, at least until such time as the studies by FDA are completed, it does not include acrylamide in food as the result of cooking or processing The information developed in the past year casts serious doubt on whether the unqualified listing of acrylamide is scientifically and legally justified at this time. Stated otherwise, we propose that, had the information presently known been available when acrylamide was listed, the listing may have been limited to exposures other than from acrylamide formed from cooking and processing. Accordingly, one approach to addressing the acrylamide issue is to examine the record underlying the listing and determine whether, in light of present knowledge, acrylamide in food from cooking and processing has “been clearly shown to cause cancer.” Acrylamide was listed using the authoritative bodies mechanism and citing to evaluations performed by EPA and IARC at a time when acrylamide was known only as a synthetic chemical. Since at that time acrylamide was not known to be present in foods, it may be that neither of these authoritative bodies considered or identified acrylamide in foods as a result of cooking and processing as causing cancer. This should be considered in light of the fact that, at the present time, another authoritative body – FDA – is taking the position that current information does not warrant a change in diet. Furthermore, under Proposition 65, the determination that a chemical has been formally identified by an authoritative body “as causing cancer” requires sufficient evidence from studies in humans or animals. Consideration of the studies evaluated by EPA and IARC and the intensive studies of the last year indicates that, in light of current knowledge, there was at the time of the acrylamide listing and is today insufficient evidence for the lead agency to determine that acrylamide in foods from cooking and processing has been formally identified by an authoritative body “as causing cancer.” There were and are no studies in humans that indicate a causal relationship between acrylamide in food and cancer. In addition, the animal studies on which the listing was based were limited to several studies in rats and mice, and none involved ingestion of food. As revealed in the investigations of the last year and implicit in the FDA’s action plan, questions exist as to whether the tumors identified in the animal studies are relevant to humans, whether humans have mechanisms of defense not present in animals and whether the bioavailability of acrylamide in foods is the same as it is in other media. The mere fact that acrylamide has been present in our food supply for thousands of years throws into question the relevance of the results currently available from animal testing. Thus, it is scientifically and legally appropriate, particularly pending completion of the relevant FDA and Health Agencies studies, to acknowledge that acrylamide in foods from cooking and processing has not been identified by an authoritative body to cause cancer and to modify the listing accordingly. An advantage to this approach is that it can be done expeditiously. In the event that studies now underway were actually to provide a basis for concluding that acrylamide in food from cooking and processing has “been clearly shown” to cause cancer or that FDA identifies such acrylamide “as causing cancer,” the listing can and, presumably would, then be revisited and changed accordingly by OEHHA.
Amend § 12703(b) to recognize that the NSRL for acrylamide in food is that level produced as a result of normal cooking and processing consistent with FDA requirements .
Regulatory recognition, at least on an interim basis, that acrylamide from cooking and processing should not trigger a cancer warning is consistent with current information, current FDA advice, and the rationale behind the adoption of § 12703(b) of the regulations. This approach would involve amending the language of the section to clarify that Proposition 65 does not apply to acrylamide produced from the normal cooking or heat processing of food. In adopting § 12703(b), the Agency explained in the Statement of Reasons (“SOR”) :
This exception is justified because the Act was intended to protect public health. The benefits of cooking are widely recognized. Cooking food significantly minimizes the possibility of food-borne infections. State and federal laws require that food establishments ensure that certain foods be thoroughly cooked prior to serving. In addition to its anti-microbial benefits, cooking is often necessary to make foods palatable.
When food is not palatable, people tend not to eat [which] can have health consequences as well.
The SOR for the rule also observed that requiring warnings on foods because of the presence of chemicals produced by cooking would confuse and mislead the public in at least two respects.
If the warning were to specify that it is given [because a chemical is produced from cooking the food], it could generate undue public fear about cooking food, leading some to undercook their food or avoid cooking altogether. This could result in an increase in the transmission of food-borne diseases. [On the other hand, if a warning is required on the food and if] the warning did not specify that it is given for cooking, consumers might avoid foods carrying the warning in favor of raw foods, which more likely would not carry a warning. Since most consumers cook raw food, they would expose themselves to the same listed chemicals anyway. Thus, consumers are likely to be exposed to these chemical by-products of cooking in any event.
While it is OEHHA’s view that the regulation as written does not exclude acrylamide from cooking and processing from the warning requirements per se , such an exclusion for acrylamide at this time is consistent with the purpose of this regulation. Accordingly, it is appropriate from both a legal and health policy standpoint for OEHHA to consider amending the regulations to make the risk level for acrylamide in foods the level of acrylamide formed from cooking and processing. To assure continued food safety, OEHHA might consider conditioning this risk level on its being consistent with FDA requirements. This approach would recognize FDA’s determination that, based on current information, sound considerations of public health support the conclusion that acrylamide produced from normal cooking and processing does not warrant a change in diet (which would likely be the effect of any warning). This approach also has merit because it can be undertaken immediately and without extensive study of individual cooking processes (which would require both substantial time and resources, as well as duplicating FDA efforts). Finally, by conditioning any such change on compliance with FDA requirements, there would be an immediate change in the effect of the amended regulation in the event FDA’s assessment of the risk changes; in addition, the regulation itself could be changed at that time. Amend the “naturally occurring chemical in food” exception in § 12501 to cover acrylamide produced by cooking and processing of naturally occurring substances in foods .
Although OEHHA has advised that this exception does not cover acrylamide from co oking and processing, another option that should be considered is amending the regulation to expand the exception so that it does. This approach would be consistent with the rationale behind the original exception, as well as Proposition 65 case law.
Although the current wording of the regulation may be more limited, the rationale for the current “naturally occurring” exception applies directly and equally to acrylamide:
Due to the abundance of foods which inherently contain low levels of carcinogens or reproductive toxicants, warnings could appear on a large number of food products, and consequently, diminish the overall significance of food warnings .
The Court of Appeal which upheld the current “naturally occurring” regulation observed: The electorate did not intend naturally occurring substances to be controlled by Proposition 65. Use of terms such as ‘knowingly and intentionally’ and ‘putting’ imply that human conduct which results in toxins being added to the environment is the activity to be controlled. It is reasonable to conclude that a cook does not intentionally “ put ” into the environment chemicals produced by cooking, any more than does a farmer whose seedlings produce plants containing naturally occurring Proposition 65 chemicals — the latter being exempt from Proposition 65 under the current regulation. Accordingly, amendment of the current regulation to cover acrylamide that naturally results from cooking would be a third option for addressing this issue. 4. Consider whether an existing federal or state standard provides a basis for adoption of an appropriate Interim NSRL (“safe harbor”) in § 12705 (c) or § 12703 for acrylamide in foods from cooking or processing . If OEHHA is not prepared expressly and categorically to remove acrylamide in cooked and processed foods from regulation under Proposition 65 pending completion of studies to establish whether such regulation is necessary, OEHHA should consider whether there is an existing federal or state standard that would provide the basis for an appropriate alternate interim safe harbor level that will eliminate the risk of warnings or litigation for acrylamide from cooking and processing. The current acrylamide safe harbor is based on the same EPA risk assessment and studies that provide the basis for the current unqualified acrylamide listing. Accordingly, the scientific and legal justification for the current safe harbor is as much in doubt as it is for the listing itself. At the same time, if the listing is not qualified or other action is not taken to clarify that acrylamide from normal cooking and processing is not subject to Proposition 65’s warning requirements, businesses seeking assurances under the current acrylamide safe harbor that they will not be sued would have to warn on thousands of ordinary products people eat every day — roasted almonds, beets, toast, cereal, bread, coffee, potato chips, peanut butter, spinach, French fries, milk and many others falling in this broad range of products. For the reasons described above, such warnings seem contrary to the purposes of Prop 65 and the rationale for its existing regulations. Absent a definitive safe harbor based on the risk evaluations currently ongoing at FDA and other Health Agencies, there may be an existing federal or state standard that, at least on an interim basis, would provide a reasonable basis for an alternative safe harbor that covers the levels of acrylamide found in food as the result of cooking and processing.
Additional Actions Required
In addition to consideration of the above options, we urge OEHHA to take immediate action to provide a basis for a stay in pending litigation, prevent further litigation from being filed and make clear that there is no obligation to warn pending completion of OEHHA’s review regarding acrylamide from cooking and processing in foods. Considerable effort is underway to determine whether acrylamide in foods from cooking and processing poses any risk and what actions are appropriate. When the voters enacted Proposition 65, they understood that before it would apply to require warnings, such determinations would be made by the Governor, his designated agency and the state’s experts. If litigation is allowed to continue, these important public policy issues will be decided, instead, in private litigation at the very time that the agency designated to decide on whether and in what manner Proposition 65 applies is in a regulatory process addressing precisely the same issues as those in the litigation. This is contrary to the intent of the voters. At the same time, businesses fearing that they will be the next to be sued may seek to protect themselves by issuing warnings that, for the reasons already discussed in this letter, would be misleading in the absence of any evidence that acrylamide in foods poses any risk. Accordingly, OEHHA should consider, in the course of the workshop, action it may take to clarify that warnings are not required and that litigation should be stayed pending completion of OEHHA’s review of what, if any, regulation of acrylamide in foods from cooking and processing is appropriate under Proposition 65.
* * * *
In sum, we urge OEHHA to use the upcoming workshop as a forum for evaluating and identifying the best approach in the near term to put a halt to litigation and the prospect of misleading warnings that are contrary to the purpose of Proposition 65. The workshop should focus on consideration of all reasonable options to achieve this end, and OEHHA should focus on adoption of a solution that builds on OEHHA’s role as the lead agency for Proposition 65 implementation, but does not duplicate the efforts that agencies specifically charged with food health and safety issues are undertaking to assess acrylamide in foods. Allowing the food safety agencies to complete their analysis of risk before OEHHA tries to make long-term risk based regulatory decisions will allow OEHHA to benefit from their work and then apply its Proposition 65 expertise to make decisions. Finally, pending completion of the workshop process, we urge OEHHA to issue a statement or take other action as necessary to clarify that any litigation with respect to warnings for acrylamide in foods due to cooking and processing should be stayed pending resolution by OEHHA as to the appropriate regulation of acrylamide under Proposition 65 .
Sincerely,
Agricultural Council of California
American Bakers Association
American Frozen Foods Institute
California Farm Bureau Federation
California Grocers Association
California League of Food Processors
California Retailers Association
Frozen Potato Products Institute
Grocery Manufacturers of America
National Food Processors Association
National Oilseed Processors Association
North American Millers’ Association
Snack Food Association
cc: Joan Denton
Director, Office of Environmental Health Hazard Assessment
P.O. Box 4010
1001 I Street, 19th Floor
Sacramento, California 95812-4010
The FDA has stated: “Until more is known, FDA is not recommending that consumers change their diet or cooking methods because of concerns about acrylamide.” 67 Fed. Reg. 57827, Sept. 12, 2002.
FDA Food Advisory Committee Meeting on Acrylamide, Feb. 24-25, 2003; http://www.cfsan.fda.gov/~lrd/pestadd.html#acrylamide.
Dietary Acrylamide and Cancer of the Large Bowel, Kidney, and Bladder: Absence of an Association in a Population-based Study in Sweden, L.A. Mucci et al., British Journal of Cancer 88: 84-9, Jan. 13, 2003.
http://www.cfsan.fda.gov/~dms/acrypla2.html. In addition, expert consultation convened by the World Health Organization (“WHO”) identified issues for additional research, and, at WHO’s recommendation, the Acrylamide Infonet, an international network where all interested parties can share relevant data and discuss ongoing investigations, has been established (http://www.acrylamide-food.org/); the Infonet is being managed by the Joint Institute for Food Safety and Nutrition (“JIFSAN”), a collaboration between the FDA and the University of Maryland.
Letter from Bill Lockyer, Attorney General, State Department of Justice, (by Edward Weil, Deputy Attorney General) to Raphael Metzger regarding Council for Education and Research on Toxics Proposition 65 Notices re Acrylamide, p. 5, July 9, 2002.
The two sets of FDA’s Exploratory Data on acrylamide in food: http://www.cfsan.fda.gov/~dms/acrydat2.html and http://www.cfsan.fda.gov/~dms/acrydat2.html.
This same position has been taken by the WHO, and the relevant agencies in the European Union, the United Kingdom, Canada, Sweden and Australia, among others.
Section 12703(b)(1) of the regulations provides that the 1 in 100,000 excess cancer level does not apply “where sound considerations of public health support an alternative level, as, for example . . . where chemicals in food are produced by cooking necessary to render the food palatable or to avoid microbiological contamination .”