Dispute Over Drug in Feed Limiting US Meat Exports
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.”
Held up at Codex. Read our exclusive coverage here.
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.
This article first appeared on msnbc.com. Interested in syndication? Contact us at info@thefern.org
SOURCE: http://thefern.org/2012/01/dispute-over-drug-in-feed-limiting-u-s-meat-exports/
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