Transparency vs. Confidentiality: EFSA’s new role as from March 2021

Last month, the European Council formally adopted the new Regulation on the transparency of the EU risk assessment in the food chain, which will be applicable as of 26 March 2021. As is in the name, the new provisions aim at increased transparency of EU risk assessment, which for a large deal means strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority (“EFSA”). As EFSA has been accused more than once of conflicts of interest, this is, in principle, a welcome development. For FBOs, the implications are however important – as will be demonstrated below.

The upcoming changes follow from the Commission Communication on the European Citizens Initiative on glyphosate, in which initiative EU citizens called for more transparency in scientific assessments and decision-making, and build upon the findings of the fitness check of the General Food Law. The new provisions will mainly amend the General Food Law. For reasons of consistency, the new provisions also introduce changes to eight legislative acts dealing with specific sectors of the food chain, including the Novel Food Regulation, the Additives Regulation and the GMO Regulation. Based on the publicly available proposal for the meanwhile adopted provisions on the transparency of EU risk assessment, this blogpost provides an overview of what applicants will be facing in authorization procedures for innovative food products in terms of transparency and confidentiality.

Pre-submission phase: union register of commissioned studies and general advice
Before submitting an authorization application, for instance for a Novel Food like cultured meat or insects or for a new additive, applicants will have to notify EFSA of any study they commissioned to support a future authorization application. These studies will become part of the union register of commissioned studies as managed by EFSA. The submitted studies will be made public only when an actual application follows and insofar the studies do not contain confidential information, regarding which a request for confidential treatment has been granted. The idea behind the union register is that companies (potentially) applying for an authorization submit all related information, which subsequently allows EFSA to cross-check the information on the studies performed. This way, applicants can no longer hold back unfavorable studies. This notification obligation also applies to laboratories in the EU that carry out those studies, but obviously not to non-EU laboratories as they fall outside the scope of new provisions. According to the EC’s fact sheet of 13 June 2019, consequences of non-compliance with the notification obligation shall result in a negative temporary stop in the risk assessment.

At the same time, applicants have the right to request EFSA for advice on the relevant provisions and the required content of the application for authorization in the pre-submission phase. This procedure is a response to industry demand, especially of SMEs, for further support in the preparation of applications. The advice shall, however, be provided without the input of the Scientific Panels that are in charge of the actual scientific assessment and shall not cover the specific design of a study. Furthermore, EFSA’s advice shall be made public. Based on the publicly available proposal for the transparency provisions, it seems that this will be done before an actual authorization application is being submitted.

Submission phase: citizens’ access to studies vs. confidentiality
The default setting under the new provisions is that all scientific data, studies and other information supporting applications for authorizations shall be made public by EFSA. While the new provisions aim at ensuring that stakeholders and the public have access to key safety related information being assessed by EFSA, duly justified confidentiality information shall not be made public. The new rules specify which types of information may be considered as such. As listed in the publicly available proposal, this includes production methods, the quantitative composition of the substance or product at stake, certain commercial relationships and other sensitive business information. It is the responsibility of the applicant to demonstrate that making public the information concerned would significantly harms the (commercial) interests concerned. Only in very limited and exceptional circumstances relating to foreseeable health effects and urgent needs to protect human health, animal health or the environment, confidential information shall be disclosed.

Specific sectoral food legislation will also include a list of certain types of information that may be treated confidentially. For example, a proposed change to the GMO Regulation includes the specification that certain DNA sequence information and breeding patterns and strategies may be treated confidentially. Next to the confidentiality rules, existing intellectual property rights, data protection rights and data exclusivity provisions for proprietary data, remain applicable.

When an applicant submits a request for confidentiality, it shall
provide a non-confidential version and a confidential version of the submitted information. If and when EFSA receives the submitted information, for example in case the Commission requires a scientific opinion as part of a novel food procedure, it shall publish the non-confidential version without delay and shall decide on the requested confidentiality within 10 days. Insofar the confidentiality request has not been accepted, EFSA shall subsequently publish the additional information after 2 weeks from the notification of its decision. Applicants that do not agree with EFSA’s decision may, under certain circumstances, challenge the decision before the Court of Justice of the European Union.

Once EFSA has published all the non-confidential information and before it carries out its scientific assessment, EFSA may consult third parties, including citizens, to identify whether other relevant information is available on the substance at stake. This new provision serves to mitigate the public concerns that EFSA’s assessment is primarily based on industry studies, more in particular on studies ordered by the applicant. The results of these consultations shall also be made public, as will be minority opinions to EFSA’s scientific output.

Renewals
In case of a request for the renewal of an authorization, the applicant of the renewal will have the obligation to inform EFSA on its planned studies under the new rules. EFSA shall subsequently consult stakeholders and the public on the planned studies and, taking into account the received comments, provide the applicant with advice on the content of the intended renewal application. The reason behind this pre-submission procedure is to make use of the existing experience and knowledge on the substance or product in question. The European Commission expects that the notification obligation will have a positive effect on the evidence base of EFSA, avoids the unnecessary repetition of studies, and will provide the potential applicant with useful advice. It should, however, be noted that also in this case EFSA’s advice will not stand in the way of the subsequent assessment of the renewal application by the Scientific Panels.

Additional controls on the conduct of studies
The new provisions also include measures to ensure the quality and objectivity of the studies used by EFSA for its risk assessment. First of all, the European Commission will have the right to perform controls, including audits, to verify the compliance of testing facilities with relevant standards. Competent authorities of the Member States will be involved in these controls. Through coordination with OECD GLP auditing programs, the control in non-EU countries will be facilitated as well. Secondly, the European Commission will have the right to request EFSA to commission verification studies. Such action shall only be taken in exceptional circumstances, such as in case of serious controversies or conflicting results, and will be financed by the EU.

Conclusion
The new provisions address public concerns regarding transparency, while on the other hand acknowledge that confidentiality is key to not cut down on incentives for innovation by food businesses. In other words: the new provisions seek to balance transparency and confidentiality. Food businesses are advised to substantively consider their commercial interests when submitting a dossier for authorization, since confidentiality will only be granted upon duly justified requests. Moreover, the union register for submitted studies forces food businesses to carefully plan their studies at an early stage since also studies with less favorable outcomes will in principle be made public and scrutinized on inconsistencies with later studies. At the same time, more guidance is expected from EFSA in the pre-submission phase, possibly speeding up the actual authorization procedure. Given the fact that the new provisions will apply from less than 20 months from now, food businesses may consider speeding up or delaying their application for authorization, depending on their needs.

How do we get cellular ag products to the market?

“The FDA knows just how vital it is to ensure the safety of our nation’s food supply and the critical role science-based, modern regulatory frameworks are to fostering innovation. Recent advances in animal cell cultured food products present many important and timely technical and regulatory considerations for the FDA and our partners at USDA,” said Commissioner Gottlieb. “We look forward to the opportunity to hold a meeting with our USDA colleagues as part of an open public dialogue regarding these products.”

Harvard Law School

This is a new quote taken from the website of the FDA, regarding a joint FDA – USDA meeting on animal cell culture technology on 23 and 24 October 2018 in Washington. Securing regulatory clearance is pivotal for market access of this type of products, which used to be often referred to as “clean meat,” “cell-based meat,” or “lab-grown meat,” depending on whom you would ask. Since the Good Food Conference early September, there seems to be consensus to retain the term “cell-based meat”. To date, there is however no consensus on the appropriate US regulatory framework for these products, which is why this new meeting has been set. In particular, it is not clear which federal regulatory agency – the FDA or USDA or both – has jurisdiction over these products with respect to labeling, safety and inspections, or whether these products will meet regulatory definitions relating to “meat” and “poultry.” Harvard Law School, in particular its representatives from the Food Law and Animal Law groups, recognizes the potential benefits of clean meat and other cellular agriculture products. Therefore, on 9 and 10 August 2018, the school organized the Clean Meat Regulatory Roundtable in order to address the regulatory concerns surrounding this new industry. Further to an earlier post on this subject, this is take #2 on the Harvard initiative, reporting a selection of topics discussed at that table. Also a comparison with the EU regulatory framework shall be made where relevant.

Participants Regulatory Round Table and Ruled of Play

In order to let the discussion benefit from as many perspectives as possible, representatives from academia, the industry and from interest groups participated in Harvard’s Clean Meat Regulatory Roundtable. Obviously, the meeting included a number of representatives from Harvard Law School. Furthermore, the nonprofit organizations Good Food Instituteand the Animal League Defense Fund were present. The participating companies were Mosa Meat and Fork & Goode (both working on clean meat), as well as Blue Nalu (working on clean fish). From the investor side, Stray Dog Capital was represented and from the industry DuPont provided its input. Finally, a number of US lawyers  participated, including Deepti Kulkarni from Sidley Austin LLP. I myself shared my insights on this topic from an EU perspective. To encourage openness and the sharing of information, all participants agreed to a Chatham House Rules + regime, meaning that the topics discussed during the meeting could be reported, but the participants were not at liberty to identify, either explicitly or implicitly, the identity of the speaker or his or her affiliation.

Cooperation on optimal regulatory pathway?

Amongst the participants, there was a common concern that if one party rushes unprepared to the market, ignoring the appropriate regulatory pathways, that could poison the well for the entire cellular agricultural industry. It was therefore discussed to what extent the cellular agriculture industry could cooperate regulatory-wise. It became clear that even though clean meat products share certain characteristics, finished products could be quite different in terms of formulation, composition, or other product characteristics. Nonetheless, general principles for assessing safety and product identity could be established under existing regulatory authorities. Such principles could for instance involve considerations relating to substances used in the production of clean meat, including scaffolds, growth factors, and cell culture medium or potential variations in the production process. In addition, it was discussed whether common interests could be effectively promoted through a trade association or industry group. The participants discussed various options, including setting up a dedicated association and connecting with existing organizations such as BIO.

Agency Jurisdiction

Contrary to the situation in the EU, where the European Commission is the one stop shop for obtaining a Novel Foods authorization, in the US foods can be subject to regulatory oversight by multiple federal and state agencies.  It is has not yet been decided which agency has jurisdiction over these products, or whether the products are subject to dual oversight. In general, USDA regulates meat and poultry, including the inspection of establishments that slaughter such animals or otherwise process meat and poultry products.  FDA generally regulates all other food, including fish and certain other meat and poultry products, such as bison, rabbits, and wild turkeys and ducks. In addition, FDA regulates new ingredients (as “food additives”) used in the production of foods under its jurisdiction, as well as new ingredients used in meat and poultry products that otherwise would be subject to USDA oversight.

Continuous inspections?

Meat and poultry products subject to USDA jurisdiction generally require “continuous” or daily inspection, depending upon the nature and frequency of operations. Because the production of clean meat does not involve slaughtering animals and such products would not be derived from slaughtered animals, there are open questions regarding the applicability of USDA’s inspection regime. This is even more so when clean meat products are not “harvested” daily, but on a batch-based basis.  Arguments, nonetheless, can be made in favor of USDA jurisdiction with respect to “processing” inspections and other in-market activities, as well as product labeling.  Nevertheless, at the Roundtable, there seemed to be a slight preference for FDA jurisdiction both pre-market and in-market.

Traditional meat industry’s concern of level playing field

The views of the traditional meat industry are somewhat fractured with respect to the clean meat industry. Some have taken considerable stakes in clean meat ventures (consider the investments of both Tyson and Cargill in Memphis Meats), particularly industry segments more closely involved with raising livestock are less supportive. For example, the US Cattleman’s Association submitted a petition to the USDA in February this year, asking it to establish labeling requirements that would prohibit clean meat from using terms like “meat” or “beef” in product labeling.  Most trade groups representing the traditional meat industry have called for a “level playing field” where clean meat products would be subject to some level of USDA inspection. In general, all participants at the Harvard Panel agreed that a discussion with the traditional meat industry on how clean meat should be regulated would be critical.  Notably, clean meat producer Memphis Meats and the North American Meat Institute, a trade group that represents the largest meat producers in the U.S. recently issued a joint letter to the White House outlining a regulatory regime under both FDA and USDA, and calling for a combined meeting involving the White House, USDA, FDA, and representatives of the traditional meat and clean meat industries.

Pre-market evaluation

Even if the FDA were to have some level of jurisdiction over clean meat products, it is still not completely clear what data would need to be submitted to demonstrate safety. One of the participants opined that, unlike a food additive approval, neither a GRAS determination, nor an FDA consultation (see here for an example of a consultation procedure on plant based products) would result in an affirmative regulatory approval. Some were of the opinion that a regulatory opinion short of approval would not benefit the clean meat industry, particularly in the eyes of the public.  By contrast, others particularly those familiar with the GRAS process and the requisite scientific information needed to demonstrate safety disagreed with the position that a GRAS determination would not be rigorous or otherwise appropriate. The participants then discussed that a potential hybrid model that followed the GRAS approach, but also involved a third-party safety opinion could be an option. As to the required data, it was discussed what would be the “ingredient” that would be assessed by the competent government agency. The substances used in the culture of clean meat products most likely are of relevance, even if they may qualify as mere processing aids that normally only remain as residues in the final product without technical function. One participant mentioned such substances could easily be tested in separate toxicology studies, to which reference could be made during the pre-market evaluation (US) or in the application for a Novel Foods authorization (EU).

EU market entry of Novel Foods

Compared to the US, the regulatory pathway for clean meat products in the European Union is relatively clear. Under the new Novel Foods Regulation (effective as per 1 January 2018), an application for an authorization of a Novel Food should be made with the European Commission, who will subsequently distribute this to all EU Member States. The application should in the first place contain a detailed description of the product for which an authorization is sought, as well as of its production process. Furthermore, a proposal for the purported conditions of use should be handed in and a labelling proposal that does not mislead the consumer. Last but not least, the applicant should provide scientific evidence, demonstrating the purported Novel Food does not pose a safety risk. For this purpose, tox studies that comply with Good Laboratory Practices are mandatory, as is an evaluation of the total safety strategy. This should be based on proposed uses and likely exposure, with justification to include or exclude certain studies in order to prevent cherry picking. Upon receipt of the Novel Food application, it is anticipated that the Commission will request a safety opinion from EFSA, who will evaluate, amongst other things, if the Novel Food concerned is as safe as food from a comparable food category already placed on the EU market. The EFSA evaluation should not exceed a 9 months term. Within 7 months after receipt of a positive safety opinion, the Commission should publish its implementing act, which will result in the inclusion of the approved Novel Food in the Union List. The single open end in this procedure is the term for response for the Member States, which in the former Novel Food Regulation used to be 60 days. Surprisingly enough, this term is not mentioned in the new Novel Food Regulation that applies as of 1 January this year. However, there are no reasons to believe this should be any different under the current Novel Foods Regulation.

In-Market Safety

In order to inspire consumer confidence in clean meat products, the participants discussed how to best ensure the products’ short and long-term safety, particularly against the backdrop of public fear and aversion to genetically modified foods. Despite the assurance that FDA provided regarding the safety of these foods, many consumers remain fearful or otherwise suspicious of such foods. The participants agreed that steps should be taken to avoid a similar unwarranted aversion to clean meat products, including transparency initiatives and consumer education. In this framework, it was suggested that the clean meat industry could pro-actively develop its own HACCP program, provided that the industry could reach agreement on what would be the best way to identify the hazards and applicable critical control points. To this respect, it is relevant that both FDA and USDA have HACCP regulations and have identified hazards of chemical, biological and physical nature that might be applicable to this new sector.

Labeling, marketing, product identity

Vivid discussions took place regarding whether or not clean meat or fish products could be called “meat” or “fish” respectively. Whereas some argued: “Meat is what it is, so meat it should be called”, others considered the actual name less important. Most likely, we will not see the plain term “meat” on product packaging, but rather “ground beef,” “meatballs,” or “chicken tenders”.  Some participants cautioned that, in order for products to be labeled with such product-specified terms, they generally would have to meet the general definitions for “meat” or “poultry,” unless the labeling adequately described or qualified the product.  For product placement, it is of relevance whether the clean meat products belong to the “meat department” or somewhere else, though several participants clarified that such placement is decided by agreements with retailers, rather than by regulatory oversight. All participants agreed that a so-called qualifier that would explain the exact nature of the product, could benefit the industry. Such qualifier should be a neutral term, explaining concisely how clean meat products differ positively from traditional meat products, without being pejorative vis-à-vis said traditional industry. This is easier said than done and the participants so far did not reach a common view at this point. Notably, in their joint letter to the White House, Memphis Meats and the North American Meat Institute, propose use of the term “cell-based” meat or poultry to describe products that are the result of animal cell culture. The echo of this letter was heard at the Good Food Conference, as reported above.

Information requirements in the EU

Looking at the EU framework, it is questionable whether the designation “meat” can be used for clean meat products. As an argument in favor thereof, it could be mentioned such use would make it immediately apparent that these products equal traditional meat in terms of composition. Arguments countering the use of “meat” are based on the EU Hygiene Regulation. When using a grammatical approach, it should be observed that “meat” is defined as “edible parts of [a number of defined]animals” and one could wonder if cells qualify as such. When using a functional interpretation, it can be noted that hygiene requirements applicable to meat mainly relate to slaughtering, whereas clean meat obviously is not subject to slaughter. Another argument countering the use of “meat” for clean meat products is derived from the ECJ’s TofuTown case, related to veggie cheese and soy yoghurt. In legal terms, this decision answered the question whether it was permitted to use regulated product names for new product types. The answer was a clear “no”. It is anticipated that the traditional meat industry will rely on this case to counter the use of the name “meat” for clean meat product, at least without a qualifier that will prevent any misleading of the consumer. By way of background, it is helpful to remember that under EU labeling laws, it is mandatory to designate a food product by its legal name. In the absence thereof, a descriptive name can be used or alternatively, a customary name.

Summary

Clean meat and clean fish represent an emerging sector, with the promise of revolutionary innovative products. Public perception of these products, as well as trust in the safety thereof, will be of utmost importance for market success. Reliable and effective regulatory procedures as a basis for market access will therefore be pivotal. In the US, the regulatory framework applicable to clean meat products is far from clear. Firstly, it is yet to be decided which government agency has jurisdiction over these products or whether both FDA and USDA share oversight. Secondly, there are open questions regarding the appropriate regulatory pathway and in-market inspection regime. In the European Union, the regulatory pathway for clean meat products is relatively clear. Under the new EU Novel Foods Regulation, these products qualify as Novel Foods and require a market authorization from the European Commission. The Regulation as well as various EFSA guidance documents detail at length what information should be contained in a Novel Foods application. In an optimal situation, the authorization procedure could be finalized in 18 months. In both the US and the EU however, the exact designation of these products (“meat” or not?) requires further thought. On the one hand, this will require interpretation of legal product definitions and case-law and on the other hand, the interests of the traditional meat and fish sector should be taken into account.