BPA and phthalates are among the 3,000 chemicals that the FDA has ruled safe if they get into food in very low amounts. The report notes that a number of these chemicals used in food processing and packaging materials have shown up in food. Some scientists question their safety, in part because these chemicals have not yet been studied for their cumulative effects. In addition, research proves difficult because companies often consider their formulas proprietary.

“Finding out which chemicals might have seeped into your groceries is nearly impossible, given the limited information collected and disclosed by regulators, the scientific challenges of this research and the secrecy of the food and packaging industries, which view their components as proprietary information,” Freinkel writes. “Although scientists are learning more about the pathways of these substances – and their potential effect on health – there is an enormous debate among scientists, policymakers and industry experts about what levels are safe.”

Freinkel explains how plastic food packaging is a major source of these potentially harmful chemicals, which most Americans harbor in their bodies. For instance, studies have shown phthalates—a family of chemicals used in lubricants and solvents and which imparts flexibility to plastics—passing into food from processing equipment and food-prep gloves, gaskets and seals on non-plastic containers, inks used on labels—which can permeate packaging—and even the plastic film used in agriculture.

She highlights a forthcoming study that found the phthalate DEHP in many of the 72 different grocery items sampled. Studies have associated low-dose exposure to this chemical with male reproductive disorders, thyroid dysfunction, and subtle behavioral changes.

Last month, the FDA denied a petition to ban BPA, saying in a statement that while “some studies have raised questions as to whether BPA may be associated with a variety of health effects, there remain serious questions about these studies, particularly as they relate to humans and the public health impact.”

You can read the full report here, including additional reporting on plastic alternatives.

Bisphenol-A, a common chemical used in plastic, had been proven to pass into foods

In a study published last year in the journal Environmental Health Perspectives, researchers put five San Francisco families on a three-day diet of food that hadn’t been in contact with plastic. When they compared urine samples before and after the diet, the scientists were stunned to see what a difference a few days could make: The participants’ levels of bisphenol A (BPA), which is used to harden polycarbonate plastic, plunged – by two-thirds, on average – while those of the phthalate DEHP, which imparts flexibility to plastics, dropped by more than half.

The findings seemed to confirm what many experts suspected: Plastic food packaging is a major source of these potentially harmful chemicals, which most Americans harbor in their bodies. Other studies have shown phthalates (pronounced THAL-ates) passing into food from processing equipment and food-prep gloves, gaskets and seals on non-plastic containers, inks used on labels – which can permeate packaging – and even the plastic film used in agriculture.

The government has long known that tiny amounts of chemicals used to make plastics can sometimes migrate into food. The Food and Drug Administration regulates these migrants as “indirect food additives” and has approved more than 3,000 such chemicals for use in food-contact applications since 1958. It judges safety based on models that estimate how much of a given substance might end up on someone’s dinner plate. If the concentration is low enough (and when these substances occur in food, it is almost always in trace amounts), further safety testing isn’t required.

Meanwhile, however, scientists are beginning to piece together data about the ubiquity of chemicals in the food supply and the cumulative impact of chemicals at minute doses. What they’re finding has some health advocates worried.

This is “a huge issue, and no [regulator] is paying attention,” says Janet Nudelman, program and policy director at the Breast Cancer Fund, a nonprofit that focuses on the environmental causes of the disease. “It doesn’t make sense to regulate the safety of food and then put the food in an unsafe package.”

A complicated issue 

How common are these chemicals? Researchers have found traces of styrene, a likely carcinogen, in instant noodles sold in polystyrene cups. They’ve detected nonylphenol – an estrogen-mimicking chemical produced by the breakdown of antioxidants used in plastics – in apple juice and baby formula. They’ve found traces of other hormone-disrupting chemicals in various foods: fire retardants in butter, Teflon components in microwave popcorn, and dibutyltin – a heat stabilizer for polyvinyl chloride – in beer, margarine, mayonnaise, processed cheese and wine. They’ve found unidentified estrogenic substances leaching from plastic water bottles.

Finding out which chemicals might have seeped into your groceries is nearly impossible, given the limited information collected and disclosed by regulators, the scientific challenges of this research and the secrecy of the food and packaging industries, which view their components as proprietary information. Although scientists are learning more about the pathways of these substances – and their potential effect on health – there is an enormous debate among scientists, policymakers and industry experts about what levels are safe.

The issue is complicated by questions about cumulative exposure, as Americans come into contact with multiple chemical-leaching products every day. Those questions are still unresolved, says Linda Birnbaum, director of the National Institute of Environmental Health Science, part of the National Institutes of Health. Still, she said, “we do know that if chemicals act by the same pathway that they will act in an additive manner” – meaning that a variety of chemicals ingested separately in very small doses may act on certain organ systems or tissues as if they were a single cumulative dose.

The American Chemistry Council says there is no cause for concern. “All materials intended for contact with food must meet stringent FDA safety requirements before they are allowed on the market,” says spokeswoman Kathryn Murray St. John. “Scientific experts review the full weight of all the evidence when making such safety determinations.”

Hard to measure

When it comes to food packaging and processing, among the most frequently studied agents are phthalates, a family of chemicals used in lubricants and solvents and to make polyvinyl chloride pliable. (PVC is used throughout the food processing and packaging industries for such things as tubing, conveyor belts, food-prep gloves and packaging.)

Because they are not chemically bonded to the plastic, phthalates can escape fairly easily. Some appear to do little harm, but animal studies and human epidemiological studies suggest that one phthalate, called DEHP, can interfere with testosterone during development. Studies have associated low-dose exposure to the chemical with male reproductive disorders, thyroid dysfunction and subtle behavioral changes.

But measuring the amount of phthalates that end up in food is notoriously difficult. Because these chemicals are ubiquitous, they contaminate equipment in even purportedly sterile labs.

In the first study of its kind in the United States, Kurunthachalam Kannan, a chemist at the New York State Department of Health, and Arnold Schecter, an environmental health specialist at the University of Texas Health Science Center, have devised a protocol to analyze 72 different grocery items for phthalates. Schecter won’t reveal the results before they’re published – later this year, he hopes – except to say he found DEHP in many of the samples tested.

Perhaps the most controversial chemical in food packaging is BPA, which is chiefly found in the epoxy lining of food cans and which mimics natural estrogen in the body. Many researchers have correlated low-dose exposures to BPA with later problems such as breast cancer, heart disease and diabetes. But other studies have found no association. Canada declared BPA toxic in October 2010, but industry and regulators in the United States and in other countries maintain that health concerns are overblown.

Last month, the FDA denied a petition to ban the chemical, saying in a statement that while “some studies have raised questions as to whether BPA may be associated with a variety of health effects, there remain serious questions about these studies, particularly as they relate to humans and the public health impact.”

The fact that a plastic bottle or bag or tub can leach chemicals doesn’t necessarily make it a hazard to human health. Indeed, to the FDA, the key issue isn’t whether a chemical can migrate into food, but how much of that substance consumers might ingest.

If simulations and modeling studies predict that a serving contains less than 0.5 parts of a suspect chemical per billion – equivalent to half a grain of salt in an Olympic-size swimming pool – FDA’s guidance does not call for any further safety testing. On the premise that the dose makes the poison, the agency has approved a number of potentially hazardous substances for food-contact uses, including phosphoric acid, vinyl chloride and formaldehyde.

Emerging science 

But critics now question that logic. For one thing, it doesn’t take into account the emerging science on chemicals that interfere with natural hormones and might be harmful at much lower doses than has been thought to cause health problems. Animal studies have found that exposing fetuses to doses of BPA below the FDA’s safety threshold can affect breast and prostate cells, brain structure and chemistry, and even later behavior.

According to Jane Muncke, a Swiss researcher who has reviewed decades’ worth of literature on chemicals used in packaging, at least 50 compounds with known or suspected endocrine-disrupting activity have been approved as food-contact materials.

“Some of those chemicals were approved back in the 1960s, and I think we’ve learned a few things about health since then,” says Thomas Neltner, director of a Pew Charitable Trusts project that examines how the FDA regulates food additives. “Unless someone in the FDA goes back and looks at those decisions in light of the scientific developments in the past 30 years, it’s pretty hard to say what is and isn’t safe in the food supply.”

FDA spokesman Doug Karas in an e-mail interview said that before approving new food-contact materials, the agency investigates the potential for hormonal disruption “when estimated exposures suggest a need.” But FDA officials don’t think the data on low-dose exposures prove a need to revise that 0.5 ppb exposure threshold or reassess substances that have already been approved.

Another criticism is that the FDA doesn’t consider cumulative dietary exposure. “The risk assessments have been done only one chemical at a time, and yet that’s not how we eat,” Schecter notes. (Karas counters that “there currently are no good methods to assess these types of effects.”)

“The whole system is stacked in favor of the food and packaging companies and against the protecting of public health,” Nudelman, of the Breast Cancer Fund, says. She and others are concerned that the FDA relies on manufacturers to provide migration data and preliminary safety information, and that the agency protects its findings as confidential. So consumers have no way of knowing what chemicals, and in what amounts, they are putting on the table every day.

It’s not just consumers who lack information. The companies that make the food in the packages can face the same black box. Brand owners often do not know the complete chemical contents of their packaging, which typically comes through a long line of suppliers.

What’s more, they might have trouble getting answers if they ask. Nancy Hirshberg, vice president of natural resources at Stonyfield Farm, describes how in 2010, the organic yogurt producer decided to launch a multipack yogurt for children in a container made of PLA, a corn-based plastic. Because children are particularly vulnerable to the effects of hormone disrupters and other chemicals, the company wanted to ensure that no harmful chemicals would migrate into the food.

Stonyfield was able to figure out all but 3 percent of the ingredients in the new packaging. But when asked to identify that 3 percent, the plastic supplier balked at revealing what it considered a trade secret. To break the impasse, Stonyfield hired a consultant who put together a list of 2,600 chemicals that the dairy didn’t want in its packaging. The supplier confirmed that none were in the yogurt cups, and a third party verified the information.

Previously, the FDA had published on its web site that 218,116 animals had suffered from reported adverse drug events, between the time the drug was approved and March 2011. This number, accessed by reporter Helena Bottemiller, was subsequently removed from the FDA web site when the FDA changed its reporting method for adverse effects. (A discussion of the data, and where it can be accessed, is explained in this previous article, Ractopamine in Pigs: Looking at the Numbers, by Helena Bottemiller.)

Upon its subsequent review, the FDA said, “The number of 218,116 which appears on this website is not precise because it includes reports of ineffectiveness, meat abnormalities and fertility abnormalities.  Ineffectiveness and meat abnormalities are reported as adverse events, but are not considered signs of morbidity.  Fertility abnormalities should not be included in the figure, because the drug is not approved for swine intended for breeding.”

The FDA said that the upon review of the data, the number of animals that suffered reported adverse effects related to morbidity was 160,917. In a second data set that includes more recent data, the number was 170,400. The difference between these two numbers was due to additional ADE reports being entered from a backlog.

The FDA’s analysis of the underlying data was made available to the Food & Environment Reporting Network on March 14, 2012.

The FDA further stated that “the quality of many of the ADE reports is lacking.  For example, several of the ADE reports did not include actual numbers of animals treated or reacted.  This is not unusual for ADE reports submitted for animals managed as a herd.  In these cases, the reporting firm generally estimates the number of animals that may have been involved  … In addition, the 218,116 figure from the prior Cumulative ADE Summaries web page does not take into account any potential confounding factors, such as dosage, concomitant drug use, the medical and physical condition of the animals at the time of treatment, environmental and management factors, and/or extra-label uses.”

It further stated: “It is also inappropriate to make use of ADE data to compare the safety of different drugs.  For example, if a drug is widely used to treat certain conditions, there may be more ADEs for that drug than another product that is not used as often. This does not mean that the first drug was more unsafe than the second. The number of reports simply represents the numbers of ADEs received for a particular drug, by species, and route of administration.”

Bottemiller’s article, however, did not attempt to calculate the relative risk of using ractopamine, only stating that pigs had more absolute numbers of ADEs from ractopamine than from any other drug. Elanco declined to release usage data on ractopamine.

Finally, the FDA added: “FDA’s Center for Veterinary Medicine continues to believe that ractopamine is safe and effective when used in accordance with the approved labeling.”

But the new regulations won’t cover nitrates—at least for now.

The adopted plan is based on a three-tiered program. For the 3 percent of large farms that use pesticides, large quantities of fertilizer and operate near polluted waters will come under the greatest scrutiny. For most farms regulations will actually loosen, but beginning next year all farmers will have to prepare compliance reports and water quality plans that detail how they will control discharges of pesticides, herbicides and sediment.

But in an effort to encourage cooperation among farmers the board agreed to give the agricultural industry until 2015 to create a third-party coalition and plan to monitor so-called nutrient management, the application of fertilizers on crops. Synthetic fertilizers and animal manure are the major source of nitrates in groundwater, a growing problem that plagues farming communities with tainted drinking water.

In another concession to the agriculture industry, the board agreed to establish “nitrogen balance ratios” as benchmarks rather than enforceable standards for subset of the approximately 100 tier 3 farmers who grow nitrogen intensive crops like lettuce and broccoli. The nitrogen ratios reflect the area fertilized and the quantity of fertilizer used.

“We think we did a whole lot of compromising,” said Roger Briggs, executive officer for the water board.

Ironically, in spite of the severity of the nitrate problem detailed in the state Water Resources Control Board-commissioned report released Tuesday, none of the information could be introduced into the two-day water board hearing because it was a continuation of a previous meeting in September when the board didn’t have a quorum. Public comment for the meeting ended Aug. 1. Even if they report could have been entered into the record the board wouldn’t have had time to absorb it before the week’s meeting, Briggs said.

“We couldn’t mention the nitrate report at all,” said Jennifer Clary, program manager for Clean Water Action, a national environmental advocacy group.

Neither environmentalists who supported greater regulation nor farmers who feared onerous new rules are entirely happy with the water board’s decision. Briggs said he would be surprised if at least one party didn’t appeal the decision. Any group that plans to do so has 30 days to submit an appeal.

In spite of the amendments, Briggs said the intent of the new regulatory program remained intact. He said his staff was willing to compromise on timetables and methodology, but not on water quality protection or public health.

“From that standpoint it’s a big win,” he said. “I think it’s way more effective than what we had which was basically nothing.”

Briggs also applauded the water board for standing up to what he said was the most intense political pressure he’s seen in his 40 year career. Five legislators or their representatives addressed the board and all sided with agricultural industry against the regulations. Rep. Sam Farr (D-Carmel), generally seen as an environmentalist, took the podium and urged the board to continue to work with the agricultural industry to find a mutually agreeable solution to water quality and avoid a “penalistic” approach that might drive farmers away.  Farr’s17th congressional district includes the Salinas Valley.

Clary said the board’s action was less than she had hoped for, but it should still be seen as progress because there will be water quality monitoring and data collection.

“We are moving forward,” she said.

The most comprehensive assessment so far to date, the report also reveals that agriculture is the main source of 96 percent of nitrate pollution. The five counties in the study area – among the top 10 agricultural producing counties in the United States – include about 40 percent of California’s irrigated cropland and more than half of its dairy herds, representing a $13.7 billion slice of the state’s economy, Holbrook reports.

“Nearly 10 percent of the 2.6 million people living in the Tulare Lake Basin and Salinas Valley might be drinking nitrate-contaminated water, researchers found. If nothing is done to stem the problem, the report warns, those at risk for health and financial problems may number nearly 80 percent by 2050,” writes Holbrook.

High nitrate levels in drinking water have been linked to thyroid cancer, skin rashes, hair loss, birth defects and “blue baby syndrome,” a potentially fatal blood disorder in infants.

Holbrook explains that nitrates are odorless, tasteless compounds that form when nitrogen from ammonia and other sources mix with water. While nitrogen and nitrates occur naturally, the advent of synthetic fertilizer has coincided with a dramatic increase in nitrates in drinking water. He notes that rural residents are at greater risk because they depend on private wells, which are often shallower and not monitored to the same degree as public water sources, writing, “Current contamination likely came from nitrates introduced into the soil decades ago. That means even if nitrates were dramatically reduced today, groundwater would still suffer for decades to come.”

According to the report, removing nitrates from large groundwater basins is extremely costly and not technically feasible. One relatively low-cost alternative is called “pump and fertilize” pulling nitrate-saturated water out of the ground and applying it to crops at the right time to ensure more complete nitrate uptake.

The report lists a few solutions to help pay for the cleanup of contaminated water, including a fee on fertilizer sales and greater “mill fees” on the production of fertilizer, Holbrook notes, explaining that in California, farmers do not pay sales tax on fertilizer, while water districts and communities bear the cost of cleaning up tainted wells.

The timing of the report is important, notes Holbrook, because the Central Coast water board, one of several regional water agencies that enforce the state’s Clean Water Act, will hold a highly anticipated meeting tomorrow, March 14, to decide on new agricultural regulations aimed at reducing the release of nitrates, pesticides and other chemicals into aquifers, as well as creeks, rivers, lakes and the Pacific Ocean.

You can read the full report here. Look out for follow-up reporting on nitrate contamination here on our blog. You can find past articles here in our archive.

This story was distributed in conjunction with California Watch, a nonprofit investigative news group founded by the Center for Investigative Reporting.

A tractor fertilizing a field in the Salinas Valley, CA

Nitrate contamination in groundwater from fertilizer and animal manure is severe and getting worse for hundreds of thousands of residents in California’s farming communities, according to a study released today by researchers at UC Davis.

Nearly 10 percent of the 2.6 million people living in the Tulare Lake Basin and Salinas Valley might be drinking nitrate-contaminated water, researchers found. If nothing is done to stem the problem, the report warns, those at risk for health and financial problems may number nearly 80 percent by 2050.

The report is the most comprehensive assessment so far of nitrate contamination in California’s agricultural areas.

“The problem is much, much, much worse than we thought,” said Angela Schroeter, agricultural regulatory program manager for the Central Coast Regional Water Quality Control Board, a state water agency.

High nitrate levels in drinking water are known to cause skin rashes, hair loss, birth defects and “blue baby syndrome,” a potentially fatal blood disorder in infants. A recent National Institutes of Health study linked increased risk of thyroid cancer with high nitrate levels in public water supplies.

Nitrate-contaminated water is a well-documented fact in many of California’s farming communities. The agricultural industry, however, has maintained that it is not solely responsible because nitrates come from many sources.

But according to the UC Davis report, 96 percent of nitrate contamination comes from agriculture, while only 4 percent can be traced to water treatment plants, septic systems, food processing, landscaping and other sources.

San Jerardo resident Horacio Amezquita stands near the cooperative's water source near Salinas, CA. The water is piped in from a clean well some distance away.

In addition to health risks, tainted water will exact a growing financial toll, the report said. The researchers project that utilities and citizens in the two regions will pay $20 million to $36 million per year for water treatment and alternative supplies.

According to the study, more than 1.3 million people in the two areas currently face increased costs as residents seek alternative sources of water and providers pass on the costs of treatment to ratepayers.

The five counties in the study area – among the top 10 agricultural producing counties in the United States – include about 40 percent of California’s irrigated cropland and more than half of its dairy herds, representing a $13.7 billion slice of the state’s economy.

The Central Coast Regional Water Quality Control Board has produced several reports of its own that show “large-scale degradation” of drinking water aquifers due to nitrates from fertilizer.

“If we don’t address this, we’re going to have a very serious issue in California,” Schroeter said.

Nitrates are odorless, tasteless compounds that form when nitrogen from ammonia and other sources mix with water. While nitrogen and nitrates occur naturally, the advent of synthetic fertilizer has coincided with a dramatic increase in nitrates in drinking water.

Rural residents are at greater risk because they depend on private wells, which are often shallower and not monitored to the same degree as public water sources. Current contamination likely came from nitrates introduced into the soil decades ago. That means even if nitrates were dramatically reduced today, groundwater would still suffer for decades to come.

According to the report, removing nitrates from large groundwater basins is extremely costly and not technically feasible. One relatively low-cost alternative is called “pump and fertilize:” pulling nitrate-saturated water out of the ground and applying it to crops at the right time to ensure more complete nitrate uptake.

Representatives of the California Farm Bureau Federation, the state’s largest agricultural association, would not comment on the report until it was released. But in a written statement, spokesman Dave Kranz said farmers and ranchers have worked on better nitrate management for years.

“Clean drinking water is a high priority for everyone, especially people who live in rural areas,” Kranz said. “Most farmers live where they work and want to be certain that they, their families, their employees, and their neighbors have access to safe water.”

Farmers and ranchers will continue to adapt to new information, technology and science to address nitrate problems, he said. But he said it’s important to “make sure nitrate management programs look at all possible sources to achieve the goal of safe drinking water.”

The safety of groundwater, which is the largest source of drinking water, is managed through the state’s Clean Water Act. But each source of contamination is handled differently, says Schroeter of the Central Coast water board, and agriculture is more lightly regulated than other industries.

Sonja Lopez and her son Leonardo at their home at the San Jerardo Cooperative in Salinas, CA. Sonja moved to the cooperative to be assured of clean drinking water for her self and her family.

For the 250 people living in San Jerardo, a farm-worker cooperative southeast of Salinas, the threat posed by nitrates is all too familiar. San Jerardo residents live in refurbished old barracks that have been converted into tidy homes.

Sonia Lopez moved into San Jerardo with her parents and five siblings in 1987. The four-bedroom, four-bathroom house was a big improvement over the two-bedroom apartment they once shared. “This was our American dream,” she said.

But something went wrong about nine years ago. Her skin became red and itchy. Her eyes burned. Her hair started falling out. Her family had the same symptoms, and she learned other San Jerardo residents were afflicted, too.

“I got very concerned because some of the residents started passing away from cancers,” she said. “People were dying, and we didn’t know who was going to be next.”

While they did not find a cause for the cancers, Lopez and fellow resident Horacio Amezquita learned from health officials that nitrates in their well water had made their eyes red and their hair fall out.

The community also learned that its water had been contaminated with nitrates since at least 1990; over the years, three wells had been drilled and eventually were found to be tainted. Drinking water regulations limit nitrates to less than 45 parts per million. One well measured 106 ppm, more than double the limit.

After repeatedly asking Monterey County officials to help, Lopez and Amezquita finally got a filtration system in 2006, and in 2010, the community connected to a new well two miles away that doesn’t need to be purified. The cost to Monterey County was about $5 million. San Jerardo residents used to pay about $25 a month for water; now, they pay as much as $130 a month.

Lopez still worries about her health, and like the UC Davis researchers, she warns the nitrate problem will only get worse.

“Our problem is going to be your problem,” she said. “It’s everyone’s problem. There are solutions, but we need the people in charge of our communities to do something about it.”

UC Davis hydrologist Thomas Harter led the team of researchers from the Center for Watershed Sciences that prepared the report, which took 20 months to complete and involved 26 scientists. The report had been requested by the Legislature in 2008.

Water-quality experts said the study provides a new and comprehensive look into the sources of the contamination, the chemicals in the water and the people affected.

Click the image to see the entire graphic.

Laurel Firestone, co-executive director of Tulare County’s Community Water Center, a nonprofit that helps communities with poor drinking water, said not only does the study show that the nitrate problem isn’t limited to a few isolated rural communities, but it also places responsibility squarely on agriculture’s shoulders. Firestone hopes there will now be the political will to tackle the issue.

“This isn’t a new problem,” she said. “We’ve known it for decades, but we’ve failed to do anything about it.”

The report lists a few solution to help pay for the cleanup of contaminated water, including a fee on fertilizer sales and greater “mill fees” on the production of fertilizer. In California, farmers do not pay sales tax on fertilizer, while water districts and communities bear the cost of cleaning up tainted wells.

Firestone said a fertilizer fee could be a powerful tool because there’s currently no disincentive to use fertilizer and few incentives to switch to safer agricultural practices.

“I think it’s clear that to address this problem, we need agriculture to lead the way,” she said.

Because of the might of the state’s agricultural industry, there has been little political will to tackle the nitrate problem. It will be up to the Legislature to decide how to respond to Harter’s report, but regulatory change might be coming as soon as this week.

The Central Coast water board, one of several regional water agencies that enforce the state’s Clean Water Act, will hold a highly anticipated meeting tomorrow to decide on new agricultural regulations aimed at reducing the release of nitrates, pesticides and other chemicals into aquifers, as well as creeks, rivers, lakes and the Pacific Ocean.

“We justify these regulations based on very severe threats to water quality,” said Schroeter, agricultural regulatory program manager for the water board.  “We have the most toxic water in the state.”

Despite the report’s grim news, water policy expert Jennifer Clary said she believes change is coming. She is a program manager for Clean Water Action, a national environmental advocacy group. She said the Central Coast water board’s plan would be a first step toward regulating groundwater contamination.

While she said the proposed rules aren’t perfect, “it’s going to be better than nothing. You can’t continue with nothing.”

Harter, the UC Davis researcher, said the study’s long-term projections for nitrate contamination reveal “just how extensive and interconnected these impacts are.” While his report outlined a number of policy choices, he doesn’t recommend one particular course of action.

“We can certainly do better, but it’s going to take an investment that we will all have to share. … That’s a discussion I hope we have.”

The numbers used in our reporting came from a March 2011 summary Cumulative Veterinary Adverse Drug Experience (ADE) Reports, which were previously publicly available on the U.S. Food Drug Administration’s Center for Veterinary Medicine (CVM) website.

According to FDA, ADE reports include domestic adverse drug experience reports that have been submitted to that CVM and that the agency “has determined to be at least ‘possibly’ drug related.” The purpose of the database is to provide a warning and monitoring system for the agency on adverse effects that weren’t necessarily detected during the drug approval process.

The agency recently changed how it shares the summaries of ADE reports online. In the past, CVM has reported the number of animals involved in adverse reports, now CVM only reports the number of times a certain sign, e.g., “death” or “lameness,” is reported and they could involve one animal or thousands. The most updated summary report is available here. (Page 242 shows the numbers of reports for ractopamine given to pigs)

The March 2011 cumulative summary can be accessed via Archive.gov, a non-profit internet library that accesses and stores information from government websites. Here is a link to the archived report (click on N-S – ADE Summaries and see page 179), note that the page may take a minute or two to load.

According to this summary, 218,116 pigs have been evaluated in adverse reports submitted to the agency. The top ten most frequently reported signs were, “Death, Recumbency, Lameness, Hyperactivity, Reluctant To Move, Stiffness, Trembling, Dyspnea, Collapse, and Hoof Disorder.”

If you look at page 183 of the same document, another 2,143 pigs were evaluated for adverse reports for combination drug ractopamine and tylosin, which is an antibiotic approved for pigs and cattle.  The top ten most frequently reported signs for this combination drug were, “Lameness, Vocalization, Biting/chewing, Death, Hoof Disorder, Locomotion Disorder, Pain, Recumbency, Reluctant To Move, Shaking.”

Looking at the March 2011 data for each drug , A-Z , it is clear to see that there were far more pigs reported to be adversely affected by ractopamine than any other animal drug. The next highest number, 32,738 pigs, is for Tylosin.

As CVM notes on their website, there are limitations to ADE data. The reports vary in quality. For example, a farmer might call and complain about increased lameness or hyperactivity in pigs on ractopamine and not provide specific numbers. Or it may not be clear ractopamine necessarily caused the adverse effect.

However, the ADE reports provide the only publicly-available window into animal drug performance and adverse effects. In the case of ractopmine, there is no other adverse report data to look at. We filed a Freedom of Information Act request to get the details of each ADE report for ractopamine to look at them more carefully. In April 2011, the FDA released 464 pages of ADE reports, which included all classes of animals ractopamine is approved for: turkeys, cattle, and pigs. The ADE reports also include accidental human, dog, and horse exposures.

See a sample of these reports for pigs here, or download the full report here.

To help analyze these reports, we consulted with multiple independent animal scientists and veterinarians on ractopamine, including two researchers who have studied the drug’s impact on animal behavior and welfare (and one researcher whose study was submitted in an ADE report) to help augment the data weaknesses. We also looked at peer-reviewed research on ractopamine and animal behavior (see below).

Another key factor in the investigation of ADE reports was the circumstances under which FDA asked drug maker Elanco to add a warning label to ractopamine approved for pigs, commercially sold as Paylean, three years after the drug was approved by the agency. The warning label reads: “CAUTION: Ractopamine may increase the number of injured and/or fatigued pigs during marketing. Not for use in breeding swine.”

As reported in the msnbc.com article,  the company also received a warning letter from the FDA that year for failing to disclose all data about the safety and effectiveness of the drug.” (See the warning letter here or download the pdf here.)   We recently issued a clarification on the msnbc.com story to make clear that the adverse drug effects we cited for ractopamine were reported to the FDA. The story adds that the FDA says such data do not establish that the drug caused these effects.

More on ractopamine and pigs:

The effects of ractopamine on the behavior and physiology of finishing pigs – Journal of Animal Science, 2003

Effects of a “step-up” ractopamine feeding program, sex, and social rank on growth performance, hoof lesions and Enterobacteriaceae shedding in finishing pigs – Journal of Animal Science, 2008

Behavior and peripheral amine concentrations in relation to ractopamine feeding, sex and social rank of finishing pigs – Journal of Animal Science, 2009

Aggressiveness and brain amine concentration in dominant and subordinate finishing pigs fed the β-adrenoreceptor agonist ractopamine – The Journal of Animal Science, 2010

“Why Ractopamine Increases Aggressive Behavior” July 14 2010

The story has been recommended by a number of other news sources, including The New York Times and CNN, and has inspired reporting in Mother Jones, Grist, Huffington Post, SF Weekly, the Taipei Times and Food Safety News. Reporter Helena Bottemiller appeared on New York Public Radio to discuss the story on Thursday. And we’ve had a good showing via social media: The story has generated 184 comments, been recommended on Facebook over 1,000 times, and shared 971 times through other sources. We’ve had some high profile tweeters share our news, including @RuthReichl (a member of our editorial board); Rep. @LouiseSlaughter, a microbiologist who has authored a bill that ends the non-therapeutic use of antibiotics in animal agriculture; and @SlowFoodUSA. In addition, @ProPublica’s #muckreads highlighted the story on its Web site.

Bottemiller was able to obtain exclusive documents and her reporting sheds new light on an important  and underreported human health story that has far-reaching trade implications. Through the publications of stories such as this, the Food & Environment Reporting Network uncovers news critical to the public’s right to know about food, agriculture, and environmental health. Keep your eye on this space; there’s much more to come.

“Although few Americans outside of the livestock industry have ever heard of ractopamine, the drug is controversial,” Bottemiller writes. “Fed to an estimated 60 to 80 percent of pigs in the United States, it has sickened or killed more of them than any other livestock drug on the market, Food and Drug Administration records show. Cattle and turkeys have also suffered high numbers of illnesses from the drug.”

The story reports that USDA meat inspectors have reported an increase in the number of “downer pigs”—lame animals unable to walk—who have been fed ractopamine. The Supreme Court on Monday unanimously struck down a California law that had sought to keep out of the food supply downer livestock. It overturned the lower court’s ruling on the grounds of federal preemption.

The report explains that ractopamine, which has not been proposed for human use, mimics stress hormones, making the heartbeat faster and relaxing blood vessels. In animals, it revs up production of lean meat, reducing fat. Pigs raised on it produce an average of 10 percent more meat, raising profits by $2 per head. The drug is fed to animals right up until slaughter and minute traces of it have been found in meat.

The European Union, China, Taiwan and many others have banned its use, limiting U.S. meat exports to key markets. Bottemiller explains that U.S. trade officials are pressing more countries to accept meat from animals raised on ractopamine—a move opposed by China and the EU, reporting: “Resolving the impasse is now a top agricultural trade priority for the Obama administration, which is trying to boost exports and help revive the economy.”

The trade dispute centers on safety studies conducted by drug maker Elanco. It conducted only one human study with six healthy young men, one of whom was removed because his heart began racing and pounding abnormally, Bottemiller writes. Elanco has reported that “no adverse effects were observed for any treatments,” but, within a few years of its approval, it received hundreds of reports of sickened pigs, according to records obtained by Bottemiller from the FDA’s Center for Veterinary Medicine.

The issue has been deadlocked since 2008 at the U.N.’s Codex Alimentarius Commission, which sets global food-safety standards, on the acceptable level, if any, of ractopamine in meat. Setting a Codex standard for ractopamine would strengthen Washington’s ability to challenge other countries’ meat import bans at the World Trade Organization, Bottemiller explains. The EU and China—which together produce and consume about 70 percent of the world’s pork—have blocked repeated efforts of U.S. trade officials to set a residue limit. U.S. officials say the EU does not want to risk a public outcry by importing meat raised with growth-promoting drugs, which are illegal there.

You can read the full story in our archive here, as well as additional reporting on the process at Codex here. The piece in our archive also contains additional reporting on the testing of ractopamine.

Pigs are often fed ractopamine up until slaughter to promote growth

Updated on March 23: The FDA on March 14 issued a statement in response to this report, saying it had reviewed its previously published adverse drug effect numbers on ractopamine. After excluding reports of ineffectiveness, meat abnormalities and fertility abnormalities, it said the number of animals with reports of adverse effects was 160,917. The story reflects this recent analysis by the FDA.

Updated on Feb. 22: A clarification to the Jan. 25, 2012, story “Dispute over Drug in Feed, Limiting US Exports” has been issued, making clear that the adverse drug effects for ractopamine were reported to the FDA. The story adds that the FDA says such data do not establish that the drug caused these effects. 

A drug used to keep pigs lean and boost their growth is jeopardizing the nation’s exports of what once was known as “the other white meat.”

The drug, ractopamine hydrochloride, is fed to pigs and other animals right up until slaughter and minute traces have been found in meat. The European Union, China, Taiwan and many others have banned its use, citing concerns about its effect on human health, limiting U.S. meat exports to key markets.

Although few Americans outside of the livestock industry have ever heard of ractopamine, the feed additive is controversial. Fed to an estimated 60 to 80 percent of pigs in the United States, it has resulted in more reports of sickened or dead pigs than any other livestock drug on the market, an investigation of Food and Drug Administration records shows.

Growing concern over sick animals in the nation’s food supply sparked a California law banning the sale and slaughter of livestock unable to walk, but that law was struck down by the Supreme Court Monday. Meat producers had sued to overturn California’s ban, arguing that the state could not supercede federal rules on meat production. The court agreed.

The FDA, which regulates livestock drugs in the United States, deemed ractopamine safe 13 years ago and approved it, setting a level of acceptable residues in meat. Canada and 24 other countries approved the drug as well.

U.S. trade officials are now pressing more countries to accept meat from animals raised on ractopamine — a move opposed by China and the EU. Resolving the impasse is a top agricultural trade priority for the Obama administration, which is trying to boost exports and help revive the economy, trade officials say.

U.S. exports of beef and pork are on track to hit $5 billion each for the first time, the U.S. Meat Export Federation estimates. Pork exports to China quadrupled from 2005 to 2010 to $463 million but are still only 2-3 percent of the market.

“China is a potentially huge market for us,” said Dave Warner, spokesman for the National Pork Producers Council.

Part of a class of drugs called beta-agonists, ractopamine mimics stress hormones, making the heart beat faster and relaxing blood vessels. Some beta-agonists are used to treat people with asthma or heart failure, but ractopamine has not been proposed for human use.

In animals, ractopamine revs up production of lean meat, reducing fat. Pigs fed the drug in the last weeks of their life produce an average of 10 percent more meat, compared with animals on the same amount of feed that don’t receive the drug. That raises profits by $2 per head, according to the drug’s manufacturer, Elanco, a division of Eli Lilly. It sells the drug under the brand name Paylean.

Ractopamine leaves animals’ bodies quickly, with pig studies showing about 85 percent excreted within a day. But low levels of residues can still be detected in animals more than a week after they’ve consumed the drug.

While the Department of Agriculture has found traces of ractopamine in American beef and pork, they have not exceeded levels the FDA has determined are safe.

But because countries like China and Taiwan have no safety threshold, traces of the drug have led to rejection of some U.S. meat shipments. The EU requires U.S. exporters to certify their meat is ractopamine-free, and China requires a similar assurance for pork.

Some U.S. food companies also avoid meat produced with the feed additive, including Chipotle restaurants, meat producer Niman Ranch and Whole Foods Markets.

The FDA ruled that ractopamine was safe and approved it for pigs in 1999, for cattle in 2003 and turkeys in 2008. As with many drugs, the approval process relied on safety studies conducted by the drug-maker — studies that lie at the heart of the current trade dispute.

Elanco mainly tested animals — mice, rats, monkeys and dogs — to judge how much ractopamine could be safely consumed. Only one human study was used in the safety assessment by Elanco, and among the six healthy young men who participated, one was removed because his heart began racing and pounding abnormally, according to a detailed evaluation of the study by European food safety officials.

When Elanco studied the drug in pigs for its effectiveness, it reported that “no adverse effects were observed for any treatments.” But within a few years of Paylean’s approval, the company received hundreds of reports of sickened pigs from farmers and veterinarians, according to records from the FDA’s Center for Veterinary Medicine.

USDA meat inspectors also reported an increase in the number of “downer pigs” — lame animals unable to walk — in slaughter plants. As a result of the high number of adverse reactions, the FDA requested Elanco add a warning label to the drug, and it did so in 2002.

The company also received a warning letter from the FDA that year for failing to disclose all data about the safety and effectiveness of the drug.

Since the drug was introduced, more than 160,000 pigs taking ractopamine were reported to have suffered adverse effects, as of March 2011, according to a review of FDA records. The drug has triggered more adverse reports in pigs than any other animal drug on the market. Pigs suffered from hyperactivity, trembling, broken limbs, inability to walk and death, according to FDA reports released under a Freedom of Information Act request. The FDA, however, says such data do not establish that the drug caused these effects.

“I’ve personally seen people overuse the drug in hogs and cattle,” said Temple Grandin, a professor at Colorado State University and animal welfare expert. “I was in a plant once where they used too much ractopamine and the pigs were so weak they couldn’t walk. They had five or six people just dedicated to handling the lame pigs.”

But she noted that producers have since scaled back use in response to the rash of illnesses.

“Our company takes adverse event reporting very seriously and is overly inclusive on the information we submit to ensure we’re meeting all requirements,” Elanco spokeswoman Colleen Par Dekker said. She said the label change in 2002 resulted from an ongoing process of evaluating adverse effects of the drug, adding that an industry trend towards heavier pigs contributed to rising numbers of lame animals in this period.

By 2003, with ractopamine rolling out across the livestock industry, U.S. trade officials began pressing to open world markets for meat produced with the feed additive. Their effort focused on a relatively obscure corner of the trade world — the U.N.’s Codex Alimentarius Commission, which sets global food-safety standards.

Setting a Codex standard for ractopamine would strengthen Washington’s ability to challenge other countries’ meat import bans at the World Trade Organization.

The issue has reached the last step in Codex’s approval process, but since 2008 the commission has been deadlocked over one central question: What, if any, level of ractopamine is safe in meat?

The EU and China, which together produce and consume about 70 percent of the world’s pork, have blocked the repeated efforts of U.S. trade officials to get a residue limit. European scientists sharply questioned the science backing the drug’s safety, and Chinese officials were concerned about higher residues in organ meats, which are consumed in China.

“The main problem for us is that the safety of the product could not be supported with the data,” said Claudia Roncancio-Peña, a scientist who led the European food safety panel studying the drug.

U.S. trade officials say China wants to limit competition from U.S. companies, and the EU does not want to risk a public outcry by importing meat raised with growth-promoting drugs, which are illegal there.

The issue also has strained the U.S.-Taiwan trade relationship, since Taiwan -– the sixth-largest market for U.S. beef and pork –- began testing for ractopamine last year. It found traces in American beef and pork and pulled meat from store shelves, according to local press reports.

In the U.S., residue tests for ractopamine are limited. In 2010, for example, the U.S. did no tests on 22 billion pounds of pork; 712 samples were taken from 26 billion pounds of beef. Those results have not yet been released.

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