Cloning, animal care, animal feed ingredient safety, viral threats and food protection were some recent headline issues and are expected to resonate in courtrooms and legislative arenas in the coming years. Let’s take a deeper look at some of the hot issues.

Cloning’s Question Mark

While the U.S. Food and Drug Administration has declared meat and dairy products of cloned animals to be safe for human consumption, many challenges have been mounted. For example, the Center for Food Safety issued a report in spring 2007 calling FDA’s cloning risk assessment flawed and “based more on faith than on science.” According to the consumer watchdog’s report, “Not Ready for Prime Time,” FDA failed to use peer-reviewed studies to support its conclusion that cloned animals and their offspring are safe to eat. They called for a mandatory ban until technical and ethical issues are resolved.

U.S. Senators Barbara Mikulski (D-Md.) and Arlen Specter (R-Penn.) proposed an amendment to the 2007 Farm Bill requiring additional research into the safety of products from cloned animals and their progeny.  Mikulski also introduced an amendment to require such products to be labeled. As of this writing, the amendments were included in the farm bill proposals.

On a related front, the National Organic Standards Board recommended nearly a year ago that cloned animals, their progeny and any derivative products not be used in its industry. While the recommendation was overwhelmingly approved, it has no legal effect until USDA adopts it. The board noted that it was “concerned with issues involving the progeny of animals derived using cloning technology,” and cited FDA findings about health risks to cloned animals, including “misarranged genetic code,” “which may have health implications for humans if consumed.” Simultaneously, with FDA's announcement that cloned food is safe, USDA requested that U.S. farmers voluntarily keep cloned animals off the market.

Animal Rights Activism

Early last year, a San Francisco-based animal rights organization filed a lawsuit against California’s largest hog farming operation, claiming that it confined animals in violation of the state’s anti-cruelty laws. The complaint, which also named a meat processor as a defendant, said the pork producer did not provide sufficient space in its gestation and farrowing crates for pregnant sows to move. The plaintiffs alleged harm from paying for “illegally produced goods.” The case was dismissed on judicial grounds, but it's indicative of future lawsuits.

The Animal Legal Defense Fund partnered with a student chapter at HarvardLawSchool in spring 2007 to convene a conference on “The Future of Animal Law.”  Some 300 participants heard global presenters discuss animal welfare and the environmental effects of confined-animal-feeding operations. Television personality Bob Barker received a lifetime achievement award and was recognized for generous endowments to Harvard, Columbia, Duke, Northwestern, Stanford and UCLA to support animal-law programs. Another is planned for 2009.

In New Jersey, the Society for the Prevention of Cruelty to Animals and other animal protection and environmental groups lost a challenge they had mounted to USDA regulations regarding the humane “raising, keeping, care, treatment, marketing and sale of domestic livestock.” The plaintiffs claimed that the regulations authorized inhumane industry practices and thus violated a legislative mandate to adopt humane standards. Referring to conflicting scientific evidence in the agency’s rulemaking record, the state’s appeals court made it clear in its 2007 decision that it was obligated to defer to agency expertise and that it could not substitute its judgment for USDA’s. But, despite these losses, USDA suspended operations of a California meat packing facility after an animal rights group uncovered inhumane slaughtering methods.

Animal Feed Ingredients

A study reported in a National Institute of Environmental Health Sciences publication reviewed data on animal-feeding practices and found substances in feed that raised potential human-health risks. (Amy R. Sapkota, et al., “What Do We Feed to Food-Production Animals? A Review of Animal Feed Ingredients and Their Potential Impacts on Human Health,” Environmental Health Perspectives, May 2007.)  A Johns Hopkins grant funded the researchers who found that bacteria, antibiotic-resistant bacteria, prions, arsenicals and dioxins are present in animal feed. They stated, “Despite a range of potential human-health impacts that could ensue, there are significant data gaps that prevent comprehensive assessments of human-health risks associated with animal feed.” They called for a nationwide feed-ingredient reporting system, increased research funding and “increased collaboration among feed professionals, animal producers, veterinarians and public-health officials” to address these issues.

With heightened scrutiny as a result of the pet-food contamination that led to nationwide lawsuits in 2007, this issue is not expected to lose traction.

Food Protection

In late 2007, FDA issued its Food Protection Plan, which addresses “food safety and food defense for domestic and imported products.” The plan outlines several administrative actions designed to prevent foodborne contamination, intervene at critical food-supply-chain points and respond rapidly to minimize harm. FDA’s strategy calls for increased corporate responsibility, identifying food vulnerabilities, risk assessment and communication, focused inspections and sampling. Part of the plan includes legislative changes that would expand FDA’s authority while protecting food companies’ flexibility to be vigilant and innovative in ensuring food safety. Several bills have been introduced in the 110th Congress to address these issues.

Last year’s food recalls involving contaminated spinach, peanut butter, pot pies and beef led to court filings, forcing the government to take action. Plaintiffs’ lawyers are not likely to give up this lucrative practice, so expect additional food contamination litigation whenever a Salmonella or E. coli outbreak occurs. Criminal prosecutions have not yet occurred in the United States, (except for the pet-food contamination) but careless food production processes in the United Kingdom have led to significant fines and penalties on a food producer found guilty of violating food-safety standards.

Meanwhile, foot-and-mouth disease continues to plague U.K. livestock, and deadly unidentified viruses have swept through China’s pig population. The U.S. government will remain vigilant to protect domestic livestock, imposing import bans and product confiscation, and disinfection measures on travelers to the United States from affected regions.

Lainie Decker is in Shook, Hardy & Bacon LLP’s Kansas City, Mo., headquarters. She's a member of SHB’s Agribusiness & Food Safety Practice and the Environmental Practice, where she focuses on regulatory compliance and permitting issues involving environmental statutes.  Her e-mail is