E301: Greg Jaffe on Food and Ag Policy Trends

Interview Transcript

Kate - Welcome to the Leading Voices in Food podcast. I'm Kate Stanley, a researcher at the World Food Policy Center at Duke University. I'm joined today by my co-host, Katariina Koivusaari, a researcher at North Carolina State University. Together, we collaborate on policy research for the Bezos Center for Sustainable Proteins at NC State.

Katariina - Great to have you. Greg, you have been involved in food and agriculture policy in Washington, D.C. for several decades and have worked with both Democratic and Republican administrations. Are food policy politics caught up in party differences depending on which political party is running the executive branch?

A very relevant question right now. I guess it would be wrong to say that the political party in office doesn't make a big difference in the policies being carried out by the executive branch. However, in the food and agricultural space, and especially in the areas that I focus on, which is really around these new technologies in food and Ag and how do those get into the marketplace and adopted, that difference hasn't been so big. Let me give you an example or two. I'll take you back first to about 2000, and we had the Clinton administration. We have the regulation at FDA of biotech crops, and they had a voluntary consultation process and there were a number of stakeholders and others who felt that that wasn't sufficient. The Clinton administration interpreted the Food, Drug, and Cosmetic Act to try to turn that into what they called a mandatory consultation, and they proposed a pre-market notification rule. It didn't get finished in, before the end of the administration in January of 2001. Then we had the Bush administration come in, so we went from a Democrat to a Republican. And the Bush administration looked at the same law and looked at that same proposed regulation and said, "We don't have the legal authority to do that." And they withdrew that proposal, and so we still have to this day this voluntary consultation. And I give you that example for two reasons. One, I think what we've seen when it comes to food and policy regulation by different administrations is how they interpret the law. And I can say this in very general, the Democrats have tended to be a little more expansive in how they interpreted the law to try to find more legal authority to do things that they might want to do. And the Republicans have tended to look at that language much more restrictively or look at just exactly what that language said and not try to interpret anything into it. And so, you see that difference here between what happened in the Clinton administration versus what happened in the Bush administration.

I mention this example because as many of your listeners may know, right now in this administration, we have the question about voluntary GRAS and whether that's going to become mandatory or not. And some of us who have followed that know that the current FDA has submitted to OMB, to the White House, a proposed rule to make GRAS mandatory. Well, that is-- the regulatory process for those biotech crops is also a GRAS process. It's interesting now that we have a Republican administration who's finding the authority to do that, and we'll see what actually comes out and what the courts do with it. But I think this shows that sort of difference in policies between Democrats and Republicans. But overall, we haven't seen a lot of difference.

In this new administration, I think one of the questions people had was what would happen with a technology like cell-cultivated meat? Where would the regulation of it go forward? There's many in the MAHA movement, I think, that felt that that wasn't consistent with what they wanted. But we've seen that those approvals continue to happen. Similarly, pesticides have been an issue in many administrations. Sometimes Democrats have argued to be much more restrictive in the use of pesticides and to make the regulations much harder. And Republicans have oftentimes said to make those easier for the agencies. But what we see is pesticides have moved forward under both administrations. People understand the need for pesticides to produce agriculture. We have some differences in policy, but on the whole, in this area, I think, whether it's Democratic or Republican, they have generally supported following the law.

Kate - Greg, you shared some interesting examples of across administrations how we've seen different actions be taken. And I'm curious. Under this administration, for some of these areas you work in, like these novel technologies, what do you see as driving the new federal legislative actions in food policy?

The legislative area has generally always been more partisan than the executive branch to some extent. I mean, the executive branch is interpreting laws from Congress; the Congress is setting those. But I think again, in the area of food policy, we've seen many good laws come out that have been bipartisan. And when I look at how did those laws come to be, I sort of see a couple different scenarios. One, and I don't think this is unique to food policy or ag policy, we tend to see legislation when some crisis has occurred. The example I would give in the food space was the establishment of the Food Safety Modernization Act more than a dozen years ago. And to a large extent, that was reaction to a number of outbreaks: spinach outbreaks, peanut butter outbreaks, egg outbreaks. And people getting sick, and some people even dying from those outbreaks. And so that brought a bipartisan coalition together to say, "We need to give more authority to FDA to address our food supply and ensure it's as safe as it could be." So that's one way we've seen that.

A second way we see policy change is when a policy is old or that is no longer in favor. And the example I give there is most recently, in this Congress passed the whole Milk for Healthy Kids Act, and that is a definite change in policy from the Hunger-Free Kids Act of 2010. This changes what milks, whether they're flavored, and how much fat they can have and be in the school programs. And I think in both cases, those bills were relatively partisan at the time, and yet they do opposite things. So that would be another reason that we see changes in laws.

But the third way, and I wanted to focus a little more on this, is one way the federal government gets involved and Congress gets involved is when states start regulating an area, and we start getting different standards. And then there's a push at the national level to have some sort of uniformity, some sort of have national standard for markets to work properly, for efficiency's sake and so forth. And I can give several different examples. We can go all the way back to the National Organic Law that was passed back in 1990. You had a number of states who had defined organic; they had different organic labels. Congress came together and said, "Hey, let's set up a national organic standard." We had the same thing happen with the National Bioengineered Disclosure Law, that I think happened around 2017 or 2016. In which case you had a number of states proposing legislation. You had Vermont that had passed legislation requiring mandatory labeling of genetically engineered ingredients. And in fact, the law that was passed by Congress was passed, I think, within a week or two of when the Vermont law was about to go into effect. And people felt it was better to come together and have a national standard than have different states doing different things. Because the reality is, consumers and manufacturers don't just purchase things in one state or produce things for one state. They produce it for the nation. We're a nationwide market. And then we see even those kinds of things happening today, and I go back to the pesticide area as another example. We've had different states having pesticide laws or regulations that have been different than the federal situation. We have a Supreme Court case now that the Supreme Court is going to hear in April of this year about whether that's those state regulations are preempted by the federal law. But Congress and the Farm Bill has also put in language that would ensure that the federal standard is the standard that is applied, not having multiple different state standards. So that's been a way that we've seen a lot of things happen in this food and Ag space.

Kate - We've seen a lot of food policy action at the state level in the past few years. Katariina and I were on this podcast not long ago talking about state legislation aiming to restrict how cell-cultivated meat products are labeled or even banning those products altogether. We've seen action in a variety of other areas as well. Are there issues that states have started regulating where you think we could see federal action in the near future?

I do. I think that the MAHA movement in particular has really set up a situation where we see states taking the lead on a number of issues, and we'll see whether the federal government decides to come in, and particularly Congress, to address those at a national level. For example, in the area of synthetic dyes and food additives, I think there's some 30 states that have introduced bills. And a number of which have passed, either restricting those use at all in any foods, restricting their use in school lunches, having different labeling associated with many of those ingredients. And we've seen some of those laws pass, and we've already seen some court cases. A court case in West Virginia which said that those laws are preempted by federal law. One could envision either something at FDA or in Congress that would set some uniform standard for how this moves forward federally.

You mentioned cell-cultivated meat and the three of us were involved in a paper that looked at the state regulation in that area, especially around labeling. And again, if we don't have a lot of those products on the market yet, but as those products get closer and get on the market, I could definitely see a push again to have some uniform labeling. Either again from the federal executive branch or from the legislative branch. And also, in areas like ultra-processed foods is another one. California has passed a law defining how they're going to define ultra-processed foods. We've heard that FDA may issue a definition about ultra-processed foods, but I could also see Congress getting involved eventually and setting a standard.

Katariina - I'm sure that in working with US regulatory agencies for so long, you've seen trends develop and persist over time. What would you highlight right now for our listeners?

Well, as I said, I've worked very much in this space where we talk about new science, new technology, new kinds of products coming into the marketplace and how do we regulate that? What are the policies and regulations to ensure that that's safe for humans and safe for the environment, and that there's information and access that's necessary for those safe products to, to thrive in the marketplace. And when you look at that, I think I have some observations, I guess, about the US regulatory agencies and what they've done in this area. The first one is that the science tends to move faster in the private sector and in the research community, like you're both in, than it does in the federal government. And so generally, the people in the federal government, who I have the utmost respect for, the career people, tend to always be playing catch up on the science. That the science is moving faster and they're not there. An example I would give is cloned animals. When the industry went to FDA and said, "Hey, can we put these cloned animals into the m- into the marketplace?" FDA sort of said, "Well, wait. We need to look and see whether we need to do a risk assessment to see if there's any risks out there." And they spent a couple years doing that, and they asked for a voluntary moratorium while they were figuring that out. In the end, they figured out that for many cloned animals, there was no risk and there didn't need to be regulation, but they had to catch up. They had to catch up on the science. And I think that's the first thing. It's important for industry and public sector scientists like yourselves to make as much information about new technologies and new products available in the public realm so that those experts in the federal government can stay as close as possible to what is happening.

Second is, anytime you have a first-of-a-kind product. You talked about cell-cultured meat, Kate, a little while ago. We can talk about biotech crops. We can talk about a number of genetically engineered salmon. We can talk about a number of different new products of methane-reducing feed additives. The first-of-its-kind is always going to take a little longer to figure out what is that regulatory pathway. It's great to be the first into the marketplace. You get a lot of advantages, but I guess one of the disadvantages is that you probably have a little slower regulatory timeframe. That again bodes for that transparency for that additional information. The third thing I'd mention, and you would think, oh, this is something that is sort of a given and expected, and that is the level of transparency that we have in our federal government. But that's not true. I've traveled around the world, and many governments don't have that. But interestingly, most of our regulations are, you know, they're all publicly available. There's lots of guidance documents out there. We can go online today and see GRAS applications and decisions made at FDA. We can see what information was submitted for cell-cultivated meat crop, meat, meat products, and what decision the agency made on those. We can do that for genetically engineered animals and for genetically engineered plants. And so, we do have a fair amount of transparency, and I impress upon people to use that to their advantage. I think that builds trust for consumers, but also for people in the industry. It helps them learn so they can be as efficient as possible when they go through the regulatory process. And the final thing I might mention is it may look like from the outside the government moves slow all the time. But I think having been inside the government and in the role, I played as the Chief Regulatory Officer at USDA, that slowness, in part, is to make sure that the government speaks as a single voice.

We've been talking a lot about FDA, and we talk about USDA, but there are actually some 18 or 20 different agencies that actually regulate different parts of the food supply, for example. A decision made in one agency may have some indirect impact on a decision or a regulatory process in another agency. And so, it's important before major decisions are made or major regulations are promulgated, that we have an interagency review of those things to make sure that the government is speaking consistently with one voice about how they interpret laws; about how they apply risk assessments; about how they look at safety and so forth within the context of their laws. And that sometimes takes some time. It is a big bureaucracy, a big government, and again, that could be looked at upon negatively. But at the same time you can look at upon that positively as an opportunity to make sure that the decisions that are made in one place are consistent with other decisions and other statutes in another place.

Katariina - Thank you for sharing that. It's really helpful to get more insight into the policy process. Let me ask you one final question. For organizations seeking to navigate through state and federal regulations in order to bring a food product to market, what are the key, what are key takeaways you would highlight?

Well, there are a number of them. First, I would tell companies or public researchers, whoever is bringing a product to market, to be as transparent as possible. Put as much information about your product and your technology in the public record, especially if it's in peer-reviewed journals that are accessible to everybody. That is only going to come to your benefit. That's going to help the regulators. They know that information is out there. They know that other people have that information. They can utilize that to help make decisions about whether there is a food safety or a risk to the environment, and then how maybe to address those risks. So that would be my first response. The second one is, and I think, again, this is something that I thought was going to be universal when it came to interactions between the regulated community and the regulators, but it's not around the world, and that is to consult. All the agencies that I've worked for have open door policies where they say, if you have a question, as you're thinking of bringing a product to market, come in and consult with us. Come in and talk to us. Let us help you figure out what the regulatory pathway is going to be, what the data you are going to need is, why we need that data, and go through all of that. And, in my consulting business, that's one of the things I do. I help facilitate those conversations between one of the agencies and a client. And I think that just the earlier you do that and the more often you do that, the more efficient you will be, the less money you will spend, the quicker your review process will be. And while I have clients who don't always agree with the decisions by the agencies of what information they might need or what regulatory process they have, it's still better to know that upfront and earlier in the process than later in the process. The third thing I'd mention is to be a little creative. The regulators, you know, they're trying to ensure they're representing the public, and they're trying to make sure that a product is safe for human consumption, for animal consumption, for the environment. They don't always have all the answers, and sometimes they are fitting square pegs into round holes because new technologies come along that aren't exactly a perfect fit. But be creative. Try to help them. I think, you know, sometimes working with people like me or others to help think about what a good regulatory pathway would be, what are the potential risks that really need to be addressed here that can be really helpful. The fourth thing is, you know, that the devil is always in the details. The details and the science matter, and that is something that is very important. And so, we want to look for analogies of your product or your technology to other ones that have happened in the past, and that's always good. But also understand the differences. And so, really, I think, sometimes people think, "Oh, they don't need to engage with the regulators as much about exactly what I'm doing," or "They don't need to know all those details." Those details actually do matter, and I do think those are important. And then I would finally say that, you know, it does take time, especially when we're talking about new technologies and new products, to figure out what that regulatory process will be. And we don't have neat situations. Our laws are written a long time ago. We don't want to write a new law for every new kind of product or every new kind of technology. I'm not sure that's the most efficient way to do it. But by not doing that, we're sometimes, as I mentioned earlier, fitting square pegs into round holes. We have a law, for example, the Food, Drug, and Cosmetic Act, dealt with food, but it never envisioned genetically engineered crops. It doesn't talk about biotechnology. We have a meat law that regulates meat at USDA. Didn't think about cell-cultivated meat. And we have to think about how those fit together. And sometimes we can do that without the new laws, and sometimes you need new laws. When I was at USDA, we worked on methane-reducing feed additives. FDA regulates them, but they really don't fit very well. They're not a drug, but they're also not a feed because they don't have a nutritional benefit. And so how do we fit those into the regulatory system? FDA's come up with a temporary regulatory pathway, but there's also a bill in Congress to set up a more definitive regulatory pathway. And we see that for some of these new technologies that we might see some legislation. And then the final point I would just make is to temper everybody's view that a compromise is essential in this area. No one company or no one stakeholder gets everything they want. Governing and the government's job is to, you know, figure out what's the appropriate balance. They want to ensure safety, but they also want to make sure that safe products can get to market and that consumers can get to take advantage of those products, and we can get the benefits from those products. And so all of this is always a balancing. There will always have to be some sort of compromise. And I'm not saying that's a bad thing, just pointing it out as something that people should be conscious of.

BIO

Gregory Jaffe is President of Jaffe Policy Consulting, which provides strategic advice on national and international policies involving agriculture and food, with specific expertise in sustainability, climate, bioeconomy, biotechnology, PFAS, pesticides, food safety, and food loss and waste. He recently worked as the Senior Advisor for Regulatory Affairs in USDA's Office of the Secretary and the USDA's Chief Regulatory Officer. He managed a broad portfolio of policy issues, including bioeconomy, biotechnology, biofuels, pesticides, PFAS, food safety, sustainability, and scientific research and development. Before joining USDA, Greg worked for at the Center for Science in Public Interest (CSPI), a non-profit consumer organization working on food and nutrition issues. While at CSPI worked extensively in Sub-Saharan Africa and Southeast Asia on projects funded by USAID and the Gates Foundation. He worked with government officials and stakeholders helping them develop laws, policies and regulations that allow for the adoption of agricultural technologies, including biotechnology. He advised on agricultural policy, sustainability, and trade issues, conducted capacity building, and worked on international treaty implementation.