Conference: FDA – Past, Present, and Future

Last Friday I attended a terrific conference sponsored by American University Washington College of Law’s Health Law and Policy Program and the Food and Drug Law Institute (FDLI) on the FDA – Past, Present, and Future.  From a discussion with four former FDA Commissioners—Califf, Hamburg, Kessler, and von Eschenbach—to a conversation with four former FDA chief counsels—Cooper, Hutt, Masoudi, Troy—the conference provided a fantastic perspective on the agency, both current and historical.  There was a keynote address by Henry T. Greely, the Director of the Center for Law and the Biosciences at Stanford Law School, and a plethora of fantastic breakout sessions on drugs, devices, tobacco and cosmetics, food and animal products, and biological products.  You can find the agenda and conference papers here.  This was a conference for the ages, and I was lucky to be there.

Regeneration: Los Angeles Food Policy Council Discusses Healing and Transforming the Food System

Last week, the Los Angeles Food Policy Council (LAFPC) held a community networking event on the concept of regeneration, a broad idea that addresses healing and transforming our food system, and encompasses health, access, human rights, social justice, and animal welfare.  In its description of the event, the LAFPC wrote, “At LAFPC, we envision regeneration as a paradigm shift–one that goes beyond extraction, beyond inputs and outputs and even beyond sustainability. To be regenerative, our food systems need to not only feed people, but restore our planet. Regenerative food systems give birth to new opportunities for transforming our earth, our communities and the people who inhabit them.”

The program included talks by Clare Fox, the Executive Director of the L.A. Food Policy Council, and Gunnar Lovelace, the co-founder and co- CEO of Thrive Market, an online wholesale buying club for organic and natural foods, and “learning hubs,” which divided the attendees into small groups to discuss how regeneration resonated with various aspects of the food system.

The concept of regeneration goes beyond “organic,” “clean,” “natural,” and even beyond “sustainable,” and the conversation at the event ranged from how to indicate such a concept to consumers, to how to create incentives for big agriculture to embrace regeneration, and whether change would start at the individual or systemic level, or both.

To see more LAFPC events, see their website, here.

Proposition 12 – Humane v. Humane

This fall the California ballot will include an initiated state statute, the Farm Animal Confinement Initiative, or California Proposition 12.  This statute would ban the sale of meat and eggs from calves raised for veal, breeding pigs, and egg-laying hens confined in areas below a specific number of square feet, repealing and replacing part of a 2008 California law that also addressed the humane treatment of animals.

Dr. Alison Van Eenennaam provides an interesting perspective on Prop 12 in the blog post, below, which is cross-posted from her blog, Biobeef Blog.  Dr. Van Eenennaam is a Cooperative Extension Specialist in the field of Animal Genomics and Biotechnology in the Department of Animal Science at University of California, Davis.  I also recommend reading her series of three posts on this issue that she posted in January.  The first is linked here.

Proposition 12 – Humane vs. Humane

Back in January I wrote a blog entitled Proposition 2 déjà vu about a proposed  California ballot initiative entitled “The Prevention of Cruelty to Farm Animals Act”. Sure enough that initiative qualified for the 2018 ballot, despite the clear data on the impacts as detailed in my three blog posts on this issue (Six hens a layingEvidence-based animal welfare recommendationsProposition 2 déjà vu).

I am quaintly of the opinion that objective evidence should drive public policy, and not emotions, despite having lived in California for over 30 years. And as a public scientist I remain convinced that objective facts and data are the best way to inform policy.

However, ballot initiatives in California are basically a pay-to-play scorecard. If you have the money to get the requisite number of signatures (365,880 valid signatures), then your initiative will be on the ballot, facts be damned. And so it was with Proposition 12, a Humane Society of the United States (HSUS)‐backed initiative addressing animal confinement, which has raised $5.37 million to date… And so now let’s cue the opposition funding which will no doubt be “big ag” or “corporate farming” or “evil egg” or “big chicken”, or a tearful segment of a mother on Dr. Oz, or a shockumentary on NetFlix…..but no – crickets (actually cage-free, mute crickets to be precise). As in no organized-opposition from those who grow your food, or research the best way to produce food sustainably (Hint: people who might know some things).

Wait – what? Agriculture and scientists have had enough. We know science and facts are useless (see my previous 3 blogs re this initiative and almost all of the outreach work I have ever done in agricultural science), and there just is no point in fighting initiatives funded by wealthy animal activist industry groups who use persuasive arguments based entirely on emotion while conveniently failing to mention the multiple trade-offs and unintended consequences associated with their proposed course of action. And so the usual adversaries of demonstrably bad agricultural policy i.e. “big ag”, known as farmers by the general public, and “tobacco scientists”,  known as public university faculty and researchers to most, have thrown in the towel.

And I understand that response. It is exhausting trying to fight these large, well-funded activist groups who will stop at nothing to get their way – facts and scientific consensus be damned, and it can be a lucrative pastime. Ask those trying to fight the anti-vaxxers, or the anti-GMO industry. Slowly I see my animal scientist colleagues quietly retreating into the “spiral of silence” – a tranquil place where no one fabricates facts, and where pure science can be carried out peacefully sans messy public confrontations – sometimes referred to as “the ivory tower.”

Last time UC Davis got involved in this discussion by providing objective facts regarding Proposition 2 “Treatment of Farm Animals” over a decade ago in 2008, it cost the taxpayers more than a million dollars in a lawsuit with HSUS – money that did not go to educating our students or carrying out research, and the lawsuit about wore out one of my faculty colleagues. Likely UC administration is happy we are playing dead this time around on Proposition 12 too.

And who can blame the University? It is not fun to be in the middle of a politicized, scientific controversy. However, if professionals in the field are unwilling to stand up for objective data and evidence-based decisions, who will? And that is where this discussion gets interesting.

Who is opposing Proposition 12 – if not industry or subject-matter experts? The Humane Farming Association (HFA), an animal cruelty organization that opposes the proposition on the grounds that it legalizes for several more years some practices HFA opposes. So Proposition 12 does not move fast enough for the Humane Farming Association.

Say again? With a modest $550,000, a committee backed entirely by the Humane Farming Association, is the sole funder of opposition to Proposition 12, the “The Prevention of Cruelty to Farm Animals”. And here is where it gets good. Who doesn’t like a little Humane vs Humane mud wrestling?

Bradley Miller, spokesperson for HFA’s Californian’s Against Cruelty, Cages, and Fraud “Stop the Rotten Egg Initiative” stated of rival HSUS

The Humane Society of the United States [HSUS] is once again deceiving voters, flip-flopping on the issue of cages, and perpetuating the suffering of egg-laying hens”                                            HFA

There is a video made by HFA (below and can be accessed here) summarizing their version of the June 19, 2018 California State Legislature hearing regarding Proposition 12 which contains some interesting conflict-of-interest footage, including some questioning as to how much money HSUS was making from Proposition 12 (Spoiler alert: HSUS does not have those numbers).

https://player.vimeo.com/video/277511154?app_id=122963

According to HFA, HSUS ended up collecting 664,000 signatures for the ballot, but less than a quarter (164,000) of those were collected by volunteers, the remaining signatures were collected by HSUS paid-“bounty-hunter” signature gatherers, like the one I met at the CA Davis market in January, telling me that Proposition 12 would remove non-existent “veal-crates”, and sow “gestation crates” from California production systems. This video is worth a listen, as Miller suggests the major opposition to Proposition 12 will be the humane farming associations.

Miller further stated on the HFA “Stop the Rotten Egg” page:

Prop 12 is now just a publicity stunt in search of a lawsuit. Not only does this come at taxpayer expense, HSUS’s reckless exploitation of California’s ballot measure system is putting in grave danger a wide array of existing consumer, animal, and environmental protection lawsOf the initiatives appearing on the November ballot, Proposition 12 is the dirtiest of the dozenWe’re confident that California voters won’t get fooled again and that this fraudulent initiative will be decisively rejected.”                                                                                                                                 HFA

And then there is a quote from Friends of Animals (FoA) on the HFA “Stop the Rotten Egg” page,

“This initiative should be fiercely opposed by everyone who cares about farm animal suffering. HSUS’s collusion with the egg industry is disturbing. From legalizing battery cages to allowing as little as one square foot of space per hen — this initiative would be a disaster for millions of egg-laying hens who would still be left suffering in battery cages throughout California.”                     FoA

And yet another quote from People for the Ethical Treatment of Animals (PETA) on the HFA “Stop the Rotten Egg” page

Beware! This initiative is being painted in rosy terms, but don’t be fooled… What it would actually do is allow farms to keep egg-laying hens in cages until 2022, at which time factory farms would still be able to confine uncaged hens to massive, crowded sheds with only 1 square foot of space per bird.”                                                                                                                                                        PETA

And finally this from Animals 24/7 on the HFA “Stop the Rotten Egg” page

“Time and again HFA has accurately identified fatal flaws in legislation advanced by HSUS.”    Animals 24/7

So what is a voter to do? Be guided by The Humane Society of the United States (HSUS), the Humane Farming Association (HFA), People for the Ethical Treatment of Animals (PETA), Friends of Animals (FoA), or Animals 24/7? Some of the above, none of the above, one of the above? Who is representing animal welfare, and how can you tell? You could try asking the scientific community who have spent their careers researching these questions, or farmers who happen to know a thing or two about farming – but that does not seem to be a popular route.

In the absence of objective, evidence-based measurements – there is just a “blob” of emotions, competing world-views, and fund-raising agendas. And that is not a great foundation upon which to base decisions around animal agriculture or public policy. Case in point: Proposition 2 from 2008 (see what that did to California farmers: Six hens a laying).

So it seems some cracks are appearing in the humpty dumpty coalition of “animal-themed corporations” also known as the “humane community”.  And perhaps nowhere is this rift more bizarrely illustrated than in this “Stop the Rotten Egg” page  animated video, “Proposition 12: California’s Caged Chickens Say NO!”.

For anyone that has ever met the former President and CEO of HSUS, Wayne Pecelle, who resigned February 2018 in a #MeToo moment  after a number of women accused him of sexual harassment,  the big-toothed male lead featured in this animated video is a thinly disguised provocation from one humane society (HFA) whose operations are based on the West Coast in California to another (HSUS) based on the East Coast in Maryland. Ironically the largest egg producing state in the US by far is Iowa.

On an unrelated note, buried in the fine print of Proposition 12, are the following strikeouts (and additions) that remove the scientific and agricultural research exemptions that were previously written into SECTION 5. SECTION 25992 OF THE CALIFORNIA HEALTH AND SAFETY CODE (line A below).

The proposed Proposition 12 language includes the following exemptions:

“This Chapter will not apply:

(a) During scientific or agricultural medical research.”

In other words, scientific and agricultural research animals at universities and other research facilities are subject to the provisions of the initiative – just like all of the farm animls. The implications of this change to the research exemption on things such as teaching, scientific or agricultural research, especially for genetic and nutrition research (we need individual cages to collect observations or phenotypes on each animal, and to record which egg comes from which hen), may well not be discovered until after the ballot votes are cast when agriculturalists and scientists go to perform specialized research on calves, pigs, or poultry.

It may be that those university researchers retreating to the “spiral of silence” to avoid the discomfort of a heated public discussion of Proposition 12, will eventually find their research projects thwarted by the inevitable passage of the initiative (I may have quaint opinions on how objective evidence should drive public policy, but I am a realist living in California). Yet another casualty of public policy based on emotion and propaganda, rather than informed by objective evidence and science-based recommendations.

As Mr. Miller, spokesperson for HFA’s Californian’s Against Cruelty, Cages, and Fraud, ironically lamented during his testimony before the California State Legislature, including the words “farm animal” and “protection” in a ballot initiative in California is enough to get it passed, irrespective of how the text reads, and what the ultimate impacts of its passage will be on the welfare of animals, and the people of California.

MSU Global Food Law Current Issues Conference

by Diana Winters

I was lucky over the last few days to attend and present at the MSU College of Law Global Food Law Program’s fantastic Global Food Law Current Issues Conference. At the conference there was a mix of academics, practitioners, scientists, and industry representatives, and a truly global focus. Wednesday’s discussions of dietary supplement labeling, developments in organic foods, issues regarding animal food labeling were fascinating, and the keynote on food litigation by Bill Marler, was, for a food law aficionado, a dream come true. Thursday’s talk on professional consumers in China and their effect on food safety provided an opportunity to reflect on the absence of a citizen suit provision in the FDCA, and the discussion of new technologies in product supply chains was a chance to engage with blockchain, 3D printing, and other fun stuff. These are only a few highlights of the conference, which also included discussions of intellectual property, food security, and innovation in the food space, as well as opportunities to explore the food and environment of greater Lansing, Michigan. Note: if you find yourself in East Lansing, don’t miss the Zaha Hadid designed Broad Museum of Art—a short walk from campus (picture above).

 

The value of a conference that provides a space for academics, practitioners, and scientists to meet and mingle is immense, and I’m so glad I went.

N.Y. Times on animal antibiotics in animal feed

There was a really interesting article on the use of antibiotics in animal feed in the N.Y. Times last week. Two very interesting takeaways: (1) the article highlights the flaws in FDA’s initiative to prohibit the use of antibiotic for growth promotion—as many critics noted, allowing companies to use these drugs for disease “prevention” is essentially a loophole, and (2) the market is eclipsing regulation in the context of antibiotics, as consumers increasingly demand antibiotic-free meat.

Further reading:

  • Emilie Aguirre wrote about California’s stricter rules and democratic experimentalism here.
  • Lisa Heinzerling wrote about the FDA’s poor record on animal antibiotics here.
  • I link to some resources on the background of this issue in a 2014 blog post, here.

Bringing Sustainable Plant-Based Eating to the Planet–David Yeung talks at UCLA Law

by Cheryl Leahy, The Initiative on Animals in Our Food System, Resnick Program for Food Law and Policy

The Initiative on Animals in Our Food System at the Resnick Program for Food Law and Policy hosted a discussion with David Yeung titled, “Bringing Sustainable Plant-Based Eating to the Planet: The Entrepreneurship, Investment, and Philanthropy of Hong Kong’s David Yeung and Green Monday” on March 6th at UCLA. Mr. Yeung is an award-winning social entrepreneur whose companies, Green Monday, Green Common, and Green Monday Ventures, take different approaches to solving the same problem – how to bring sustainable vegan eating to the planet. He jokingly nicknamed his companies the “Swiss army knife” of green and sustainable eating, for the diversity and efficacy of their approaches.

Mr. Yeung presented historical and factual background on the environmental and health impacts of animal agriculture and consumption and explained how he himself learned about the enormous effects the production of meat for human consumption has on the earth. He explained how cultural and market forces can be key tools in achieving change, an understanding of which led him to the launching of his companies.

Mr. Yeung imagined Green Monday as a way to reach a broad audience, asking people to reduce their animal product consumption at least one day per week as an intermediary stepping-stone to an increased reduction. Green Monday and its related companies accomplish this by partnering with institutions, including schools, restaurants, and corporations, as well as by running storefront sales showcasing plant-based foods from around the world, and by investing in and developing vegan companies and products. Since its inception six years ago, Green Monday’s reach has grown to 33 countries, with 1.6 million participants in its Hong Kong home.

David Yeung at UCLA Law

The Initiative on Animals in Our Food System at the Resnick program for Food Law and Policy, Emmett Institute on Climate Change & the Environment, Lowell Milken Institute for Business Law & Policy, UCLA Food Law Society, and UCLA Environmental Law Society invite you to hear David Yeung on Bringing Sustainable Plant-Based Eating to the Planet.  At this event, Mr. Yeung will discuss investing in and launching vegan businesses, exploring investment factors, unique problems, and legal and practical issues.

Tuesday, March 6, 2018

12:15-1:15pm

NEW LOCATION:      W.G. Young Hall, Room CS76

UCLA South Campus (across from Parking Structure 2)

 

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