Tag Archives: FDA

FDA warns against hand sanitizers that look like drinks

(Reuters) – The U.S. Food and Drug Administration (FDA) on Thursday warned of alcohol-based sanitizers being packaged and sold in containers that appear like food or drinks.

At a time when health agencies are pushing for better hand hygiene to curb the spread of the coronavirus in the United States, the top health regulator found many hand sanitizers look like beer cans, children’s food pouches, water bottles, juice bottles and vodka bottles.

Some of them were being sold with cartoons for children and had added food flavors such as chocolate or raspberry.

“These products could confuse consumers into accidentally ingesting a potentially deadly product,” FDA Commissioner Stephen Hahn said in a statement.

He warned against adding scents with food flavors to hand sanitizers as it would lead to children mistaking it for food and result in alcohol poisoning.

The Centers for Disease Control and Prevention (CDC), which has backed use of sanitizers if soap and water are not available, has reported several cases of methanol poisoning, some even fatal, caused by swallowing alcohol-based hand sanitizers.

(Reporting by Vishwadha Chander in Bengaluru; Editing by Arun Koyyur)

Gilead remdesivir study finds only marginal benefit for moderate COVID-19 patients

By Deena Beasley

(Reuters) – Moderately ill COVID-19 patients saw their condition improve after a 5-day course of Gilead Sciences Inc’s remdesivir, but the drug did not significantly shorten hospital stays and a 10-day course did not show a benefit, according to new data.

The drug, which was shown in a trial of severely ill COVID-19 patients to shorten their hospital recovery time, has been at the forefront of the battle against the pandemic.

The 600-patient analysis, published on Friday by the Journal of the American Medical Association, found that moderately ill patients treated with the antiviral drug for up to 5 days had significantly higher odds of improvement in certain areas, such as whether or not they needed supplemental oxygen, compared to patients given standard treatment.

Researchers said the clinical importance of the benefit for those patients was uncertain, however.

Remdesivir is currently sold under an emergency use authorization from the U.S. Food and Drug Administration for treating patients hospitalized with severe COVID-19, the disease caused by the new coronavirus. Gilead earlier this month filed an application seeking full FDA approval of the drug.

Differing trial results for remdesivir raise “the question of whether the discrepancies are artifacts of study design choices, including patient populations, or whether the drug is less efficacious than hoped,” according to a JAMA editorial accompanying the study.

The new study in moderately ill COVID-19 patients showed that 11 days after starting treatment, 65% of the 10-day remdesivir patients, 70% of the 5-day patients and 60% of the standard care patients had left the hospital.

Side effects seen more frequently in the remdesivir groups included nausea, low blood potassium levels, and headache.

The JAMA editorial said important questions remain regarding the efficacy of remdesivir, including which patients are most likely to benefit from the drug, the optimal duration of therapy, the drug’s impact on clinical outcomes, and its relative effect if combined with generic steroid treatments.

(Reporting by Deena Beasley; Editing by Nick Tattersall and Sonya Hepinstall)

What you need to know about the coronavirus right now

(Reuters) – Here’s what you need to know about the coronavirus right now:

Concerns grow that kids spread virus

U.S. students are returning to school in person and online in the middle of a pandemic, and the stakes for educators and families are rising in the face of emerging research that shows children could be a risk for spreading the new coronavirus.

Several large studies have shown that the vast majority of children who contract COVID-19, the disease caused by the virus, have milder illness than adults. And early reports did not find strong evidence of children as major contributors to the deadly virus that has killed more than 780,000 people globally.

But more recent studies are starting to show how contagious infected children, even those with no symptoms, might be.

Grave situation in renewed South Korea outbreak

Novel coronavirus infections have spread nationwide from a church in the South Korean capital, raising fears that one of the world’s virus mitigation success stories might yet suffer a disastrous outbreak, a top health official said on Thursday.

“The reason we take the recent situation seriously is because this transmission, which began to spread around a specific religious facility, is appearing nationwide through certain rallies,” Vice Health Minister Kim Gang-lip told a briefing.

The positive cases from the rallies include people from nine different cities and provinces across the country. Kim did not identify those places but said 114 facilities, including the places of work of infected people, were facing risk of transmission.

Brazil sees signs spread is slowing

The spread of the coronavirus in Brazil could be about to slow, the Health Ministry said, amid reports the transmission rate has fallen below a key level and early signs of a gradual decline in the weekly totals of cases and fatalities.

The cautious optimism comes despite figures again showing a steady rise in the number of confirmed cases and death toll in the last 24 hours, cementing Brazil’s status as the world’s second biggest COVID-19 hot spot after the United States.

According to ministry data, Brazil saw a drop in the number of new confirmed COVID-19 cases to 304,684 last week from a peak of 319,653 in the week ending July 25. The weekly death toll fell to 6,755 from a peak of 7,677 in the last week of July.

Trump touts convalescent plasma as treatment

U.S. President Donald Trump on Wednesday touted the use of convalescent plasma as a treatment for COVID-19 and suggested a reported decision by regulators to put on hold an emergency authorization for its use could be politically motivated. “I’ve heard fantastic things about convalescent plasma,” Trump told a briefing.

An emergency approval by the Food and Drug Administration (FDA) for the use of blood plasma as a coronavirus treatment has been put on hold over concerns the data backing it was too weak, the New York Times reported on Wednesday. The FDA did not respond to a request for comment.

People who survive an infectious disease such as COVID-19 are left with blood plasma containing antibodies the body’s immune system created to fight off a virus. This can be transfused into newly infected patients to try to aid recovery.

China backs Wuhan park after pool party

Chinese state newspapers threw their support behind an amusement park in the central city of Wuhan on Thursday after pictures of a densely packed pool party at the park went viral overseas amid concerns about the spread of COVID-19.

Videos and photos of an electronic music festival at the Wuhan Maya Beach Water Park on July 11 raised eyebrows overseas, but reflected life returning to normal in the city where the virus causing COVID-19 was first detected, the official English-language China Daily newspaper said in a front-page story.

Another story in the Global Times, a tabloid published by the ruling Communist Party’s People’s Daily, cited Wuhan residents as saying the pool party reflected the city’s success in its virus-control efforts.

(Compiled by Linda Noakes and Karishma Singh; Editing by Mark Potter)

Trump executive order to boost U.S. drug manufacturing: Navarro

WASHINGTON (Reuters) – U.S. President Donald Trump on Thursday will sign an executive order aimed at boosting American drug manufacturing and lowering drug prices, White House trade adviser Peter Navarro said as the administration continues to grapple with the novel coronavirus outbreak.

The order, first reported by USA Today, “establishes Buy American rules for government agencies, strips away regulatory barriers to domestic pharmaceutical manufacturing, and catalyzes the Advanced Manufacturing technologies needed to keep drug prices low,” Navarro tweeted.

It will allow the Department of Health and Human Services to use a 1950 law to procure certain “essential” medicines and other equipment from U.S. companies, although it does not list specific products, USA Today reported, citing the White House.

The order also directs the U.S. Food and Drug Administration and the Environmental Protection Agency to give priority status to U.S. drug ingredient manufacturers during their regulatory review process, and addresses counterfeit medicines sold by third-party sellers, according to the report.

So far, more than 157,000 people in the United States have died from COVID-19 – about 1,000 each day – with 4.8 million known COVID-19 cases.

Trump is expected to sign the order later on Thursday, USA Today said. The Republican president is scheduled to travel to Ohio to visit a Whirlpool manufacturing plant and hold a fundraiser for his re-election campaign before traveling to his New Jersey golf resort for the weekend, according to the White House.

Representatives for the White House did not immediately respond to a request for comment.

(Reporting by Susan Heavey; editing by Jonathan Oatis)

U.S. FDA releases guidance for COVID-19 vaccine approval

(Reuters) – The U.S. Food and Drug Administration on Tuesday released guidance on its conditions for approving a vaccine for the coronavirus, saying a vaccine has to prevent or decrease disease severity in at least 50% of people who are vaccinated.

More than 100 vaccines are being tested worldwide against the virus, which has claimed over 126,100 lives in the country, according to a Reuters tally.

The Trump administration in May announced a program called “Operation Warp Speed” to speed up the development of COVID-19 therapeutics and vaccines, as the country has none approved for the respiratory illness.

“While the FDA is committed to expediting this work, we will not cut corners in our decisions,” the agency said in a statement on Tuesday.

Vaccine developers have also been asked to provide data to support use of their vaccines during pregnancy and to show safety and effectiveness in children, the agency said.

Experts have suggested that it could take a minimum of 12 to 18 months to guarantee a vaccine through clinical trials.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

FDA identified 20 drugs with shortage risks due to coronavirus outbreak

NEW YORK (Reuters) – The U.S. Food and Drug Administration has contacted producers of about 20 drugs that either source all of their main ingredients from or are finished in China to gauge if they will face shortages due to the coronavirus outbreak.

None of the companies reported that a shortage is expected for their drugs due to the outbreak, an FDA spokeswoman said.

“We have been in contact with those firms to understand if they face any drug shortage risks due to the outbreak,” FDA spokeswoman Stephanie Caccomo said in a statement late on Monday. “None of these firms has reported any shortage to date.”

Caccomo did not identify any of the drugs or the companies.

She said the FDA has also reached out to more than 180 manufacturers to remind them of their requirement to notify the regulator of any expected supply disruptions.

U.S. officials raised concerns this week about the security of the U.S. drug supply chain in the wake of the coronavirus outbreak in China, where a significant portion of the ingredients used to make prescription drugs is manufactured.

Around 88 percent of the active pharmaceutical ingredients used in drugs for the U.S. market were manufactured overseas in 2018, according to the FDA. About 14 percent of the API for U.S. drugs in that year were produced in China, the FDA said.

(Reporting by Michael Erman; Editing by Dan Grebler)

Toxin at heart of drug recall shows holes in medical safety net

FILE PHOTO: The headquarters of the European Medicines Agency (EMA), is seen in London, Britain, April 25, 2017. REUTERS/Hannah McKay -/File Photo

By Alexandra Harney and Ben Hirschler

SHANGHAI/LONDON (Reuters) – A toxin inadvertently produced in the manufacture of a widely prescribed medicine but not spotted for years raises questions about regulators’ ability to detect risks in a sprawling global drug supply chain increasingly reliant on factories in China.

China’s Zhejiang Huahai Pharmaceutical, which produces bulk ingredients for drugmakers, told its customers in late June it had found NDMA in its valsartan, an off-patent blood pressure drug originally developed by Novartis.

The discovery means that some of the 10 billion pills containing valsartan sold worldwide last year to prevent heart attacks and strokes had traces of N-nitrosodimethylamine (NDMA), classified as a probable human carcinogen. No one has been reported as sickened by the toxin, once used in the production of liquid rocket fuel.

Regulators and industry experts say the toxin almost certainly was introduced when Huahai changed the way it produced valsartan in 2012 – a modification that was signed off on by the European body that sets standards. Subsequent inspections by European, U.S., and Chinese regulators also found no problem.

“Everyone failed – the company, the inspectors, the FDA (U.S. Food and Drug Administration), the Europeans, the Chinese,” said Philippe André, an independent pharmaceutical auditor who inspected two Huahai facilities last August and found no critical concerns. “It’s a system failure.”

Reuters was unable to determine how Huahai first discovered the problem. In a July 7 statement released through the Shanghai Stock Exchange, it said it detected the toxin during the “optimization and evaluation” of its manufacturing process.

A Novartis spokesman told Reuters that its generic drugs arm, Sandoz, spotted the NDMA in the course of intensive testing to prepare for expanding its purchases of valsartan. He declined to comment further, including on the identity of the manufacturer or when the tests took place.

Two other smaller bulk suppliers – Zhejiang Tianyu Pharmaceutical and a unit of India’s Hetero Drugs – have since also discovered traces of NDMA in some of their valsartan.

The three companies declined to comment to comment about the case.

REDUCE WASTE

Huahai said in a document released through the Shanghai Stock Exchange it changed the production process to reduce waste and improve yields.

“The NDMA impurity was produced in trace amounts during the normal manufacturing process according to the company’s current registered process,” it said in a statement on July 24.

“All changes in the company’s valsartan manufacturing process have been approved by each country’s drug regulator, and the company manufactures in compliance with legal and regulatory standards.”

The European Medicines Agency (EMA) regulator, which first publicly raised the alarm in a statement on July 5, told valsartan suppliers in a subsequent memo dated July 16 that the NDMA may have been connected to the combined use of the solvent dimethylformamide and sodium nitrite.

The FDA is also going on that hypothesis, said Janet Woodcock, director of its Center for Drug Evaluation and Research. She stressed the investigation was still going on.

“This (NDMA) was not what you look for in an inspection,” Woodcock said in an interview. “If you don’t test for this you’re not going to have an idea that it’s in there, and you’re not going to see it on an inspection.”

The European Directorate for the Quality of Medicines (EDQM), responsible for setting manufacturing standards, told Reuters it was aware the solvent was being used when it approved the changed process, but that NDMA as a by-product was unexpected and not tested for.

Detecting NDMA would have required gas chromatography coupled with mass spectrometry, a very sensitive level of testing, an EDQM spokeswoman said.

“These techniques are not normally used routinely to test pharmaceutical products,” she said.

RECALLS

Built by Novartis into the $6 billion-a-year brand Diovan, valsartan’s European and U.S. patents expired in 2011 and 2012.

Global sales totaled 10.4 billion pills last year, including combination products, healthcare data consultancy IQVIA estimates. People with high blood pressure typically take one pill daily and heart failure patients two.

More than 50 companies around the world making finished tablets from the tainted valsartan have recalled products in recent weeks, according to a Reuters analysis of national medicines agencies’ records. They include major generic drug manufacturers such as Teva Pharmaceutical Industries, Ranbaxy Laboratories, and Sandoz.

Based on the average NDMA impurity detected at Huahai of 60 parts per million (ppm), the EMA says there could be one additional case of cancer in every 5,000 people taking the highest dose for seven years.

The contamination puts a spotlight on manufacturers in China and India, which supply more than two-thirds of all active pharmaceutical ingredients used in medicines, industry executives estimate. China accounts for the lion’s share.

Huahai, founded in 1989 and listed in Shanghai in 2003, was one of the first Chinese companies to get drugs approved in the U.S. market.

The FDA has inspected the site that made the contaminated valsartan three times since 2010, its records show. European inspectors also visited regularly.

The provincial branch of the Chinese FDA (CFDA) also inspected Huahai facilities 10 times in connection with new drug applications between January 2016 and June 2018, the national online database shows.

SCRUTINY

U.S. and European regulators have increased scrutiny of Chinese and Indian drug factories after the adulteration of the blood thinner heparin sickened hundreds and caused the deaths of at least 81 Americans in 2007 and 2008.

The CFDA is also on alert.

Last month, it revealed that Changsheng Bio-technology , a vaccine maker, had fabricated data and sold ineffective vaccines for children. It also found that a diphtheria, tetanus and pertussis vaccine sold by the state-owned Wuhan Institute of Biological Products was substandard.

The fact that international inspections do not appear to have detected the NDMA contamination alarms Anders Fuglsang, a former European medicines regulator who runs a pharmaceutical consultancy in Denmark.

“We need to ask ourselves how it is possible – despite pharmacopoeias and agency guidelines, inspection programs with coordination across continents, a system of public quality control, and companies complying with all rules – that a nasty carcinogen can find its way into our drugs and be there for years without anyone noticing,” he said.

(Additional reporting by Shanghai newsroom, Zeba Siddiqui in Mumbai and Sharnya G in Bengaluru; Editing by Sonya Hepinstall)

Pharma’s Puerto Rico problems could mean drug shortages: FDA chief

U.S. Food and Drug Commissioner Scott Gottlieb attends an interview at Reuters headquarters in New York City, U.S., October 10, 2017. REUTERS/Eduardo Munoz

By Bill Berkrot

NEW YORK (Reuters) – The head of the U.S. Food and Drug Administration said on Tuesday the country may start to see a small number of drug shortages within two or three weeks due to delays in restoring manufacturing operations in Puerto Rico, where 10 percent of drugs prescribed in the United States are made.

Hurricane Maria slammed into the Caribbean island on Sept. 20, knocking out electricity and causing widespread damage to homes and infrastructure. Almost three weeks later, just 16 percent of electricity service has been restored to the U.S. territory.

Drugmakers are working to get facilities fully online, but face an uncertain power supply and difficulty obtaining materials used in the manufacturing process.

“A lot of companies say they’re online, but they basically have one of five lines running at 20 percent or 80 percent or 50 percent,” FDA Commissioner Scott Gottlieb told Reuters in an interview in New York. “They are not manufacturing at full capacity. They are manufacturing well short of that.”

“It’s unclear when they are going to be able to bring that up to full capacity,” he said.

Asked when U.S. hospitals and pharmacies might see shortages as a result, he said: “You might see some in the next two or three weeks if there’s going to be additional shortages coming out of this situation.”

The FDA has warned of 40 drugs made in Puerto Rico that could face shortages, including treatments for cancer, rheumatoid arthritis and HIV, but has not named specific medicines.

Most major drug companies have manufacturing facilities on the island, including Merck & Co, Johnson and Johnson, Amgen Inc, Bristol-Myers Squibb Co, Eli Lilly and Co, Pfizer Inc, AstraZeneca and GSK

The FDA leader said he wants drugmakers to provide the public with more information about the extent of the problems they are facing. He said the plants were all relying on backup generators for electricity, some of which were not designed to operate for sustained periods of time.

“I’m going to ask some of these companies to be a little more transparent around some of these issues,” he said, adding that improvements would likely come slowly, with potential setbacks along the way. “As time goes on, we’re going to see secondary impacts like the generators could start going down.”

Gottlieb said he was “troubleshooting for individual companies” on a daily basis and working with the U.S. Federal Emergency Management Agency and the Department of Homeland Security to address issues such a fuel shortages and shipping problems that could stall operations.

Most of the companies contacted by Reuters said they are working to avoid product shortages.

Bristol-Myers said it has resumed limited operations to ship warehoused products. “As of today, no product supply impact is expected, however we continue to assess the challenging operational conditions on the island,” spokesman Ken Dominski said.

Amgen, in a statement, said it was “preparing to resume manufacturing in various plants over the next several weeks” and did not anticipate an impact on supply to patients.

Merck has one manufacturing facility on the island. “We have brought power back online via on-site generators that will allow most operations to proceed,” spokeswoman Claire Gillespie said.

Of the list of drugs being closely monitored by FDA, 14 medicines are sourced solely out of Puerto Rico, Gottlieb said.

He said the agency was working with drugmakers and would consider approving manufacturing sites in other countries, such as Mexico, Canada or Ireland, to alleviate possible shortages if companies have plants there.

(Additional reporting by Caroline Humer and Michael Erman in New York and Toni Clarke in Washington; Editing by Michele Gershberg and Bill Rigby)

ACLU sues over FDA restrictions on abortion pill access

FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. Picture taken August 14, 2012. REUTERS/Jason Reed

By Nate Raymond

(Reuters) – The American Civil Liberties Union filed a lawsuit on Tuesday seeking to challenge U.S. Food and Drug Administration restrictions that limit the ability of women to access the so-called abortion pill.

The ACLU filed the lawsuit in U.S. District Court in Hawaii to challenge FDA restrictions that limit the dispensing of the pill, Mifeprex, to clinics, medical offices or hospitals rather than retail pharmacies.

The ACLU said that as a result, the FDA’s restrictions delay and in some cases block a woman’s access to abortion by requiring her to be handed Mifeprex by healthcare providers who have arranged to stock it in their facilities.

That is despite the fact that Mifeprex, which can be used for abortions up to 10 weeks into a pregnancy, is considered safe and has been recognized by the FDA itself as providing “meaningful therapeutic benefit,” the lawsuit said.

“The unique and harmful restrictions the FDA imposes on where and how a patient may receive Mifeprex deny women meaningful access to this safe and effective treatment with no medical justification,” the complaint said.

The FDA declined to comment.

Mifeprex, manufactured by Danco Laboratories, was approved in 2000 to terminate early pregnancy when given in combination with misoprostol, an anti-inflammatory drug that was originally approved to prevent gastric ulcers.

The lawsuit came after the FDA in March 2016 announced a decision to relax restrictions on the use of Mifeprex that were in place for over a decade.

The FDA eased access to it by updating the prescribing information on the drug’s label, thus expanding use to 70 days of gestation from 49 days, cutting the recommended dose of the drug and reducing the number of required visits to a doctor.

The ACLU filed its lawsuit on behalf of three healthcare associations and a family medicine doctor, Graham Chelius, who is based on the Hawaiian island of Kauai, which has no abortion providers.

According to the ACLU, while Chelius is qualified and willing to provide the pill, he cannot stock it at the hospital where he works due to objections from some colleagues and as a result his patients must fly to another island for abortions.

To support its case, the ACLU cited a June 2016 U.S. Supreme Court ruling that struck down a Texas abortion law imposing strict regulations on doctors and facilities.

(Reporting by Nate Raymond in Boston; Editing by Jonathan Oatis)

Exclusive: Vomitoxin makes nasty appearance for U.S. farm sector

FILE PHOTO -- Cobs of corn are held at a corn field in in La Paloma city, Canindeyu, about 348km (216 miles) northeast of Asuncion August 7, 2012. Corn export is second only to soybean export in Paraguay. REUTERS/Jorge Adorno/File Photo

By P.J. Huffstutter and Michael Hirtzer

CHICAGO (Reuters) – A fungus that causes “vomitoxin” has been found in some U.S. corn harvested last year, forcing poultry and pork farmers to test their grain, and giving headaches to grain growers already wrestling with massive supplies and low prices.

The plant toxin sickens livestock and can also make humans and pets fall ill.

The appearance of vomitoxin and other toxins produced by fungi is affecting ethanol markets and prompting grain processors to seek alternative sources of feed supplies.

Researchers at the U.S. Department of Agriculture first isolated the toxin in 1973 after an unusually wet winter in the Midwest. The compound was given what researchers described as the “trivial name” vomitoxin because pigs were refusing to eat the infected corn or vomiting after consuming it. The U.S. Corn Belt had earlier outbreaks of infection from the toxin in 1966 and 1928.

A vessel carrying a shipment of corn from Paraguay is due next month at a North Carolina port used by Smithfield Foods Inc [SFII.UL], the world’s largest pork producer.

The spread of vomitoxin is concentrated in Indiana, Wisconsin, Ohio, and parts of Iowa and Michigan, and its full impact is not yet known, according to state officials and data gathered by food testing firm Neogen Corp.

In Indiana, 40 of 92 counties had at least one load of corn harvested last fall that has tested positive for vomitoxin, according to the Office of Indiana State Chemist’s county survey. In 2015 and 2014, no more than four counties saw grain affected by the fungus.

And in a “considerable” share of corn crops tested in Michigan, Wisconsin and Indiana since last fall’s harvest, the vomitoxin levels have tested high enough to be considered too toxic for humans, pets, hogs, chickens and dairy cattle, according to public and private data compiled by Neogen. The company did not state what percent of each state’s corn crop was tested.

Smithfield would not confirm it had ordered the corn from Paraguay, but two independent grain trading sources said Smithfield was the likely buyer. A company source said corn Smithfield has brought in from Indiana and Ohio, to feed pigs in North Carolina, has been “horrible quality” due to the presence of mycotoxins.

TOXIN LEVELS

The U.S. Food and Drug Administration allows vomitoxin levels of up to 1 part per million (ppm) in human and pet foods and recommends levels under 5 ppm in grain for hogs, 10 ppm for chickens and dairy cattle. Beef cattle can withstand toxin levels up to 30 ppm.

Alltech Inc, a Kentucky-based feed supplement company, said 73 percent of feed samples it has tested this year have vomitoxin. The company analyzed samples sent by farmers whose animals have fallen ill.

“We know there is lots of bad corn out there, because corn byproducts keep getting worse,” said Max Hawkins, a nutritionist with Alltech.

Neogen, which sells grain testing supplies, reported a 29 percent jump in global sales for toxin tests – with strong demand for vomitoxin tests – in their fiscal third quarter, ending Feb. 28.

“We’re polling our customers and continually talking to them about the levels they’re seeing. Those levels are not going down,” said Pat Frasco, director of sales for Neogen’s milling, grain and pet food business.

The problem, stemming from heavy rain before and during the 2016 harvest, prompted farmers to store wet grain, said farmers, ethanol makers and grain inspectors.

The issue was compounded by farmers and grain elevators storing corn on the ground and other improvised spaces, sometimes covering the grain piles with plastic tarps. Grain buyers say they will have a clearer picture of the problem later this spring, as more farm-stored grain is moved to market.

Iowa State University grain quality expert Charles Hurburgh said the sheer size of the harvest in 2016 – the largest in U.S. history – complicates the job of managing toxins in grain, especially in the core Midwest.

“Mycotoxins are very hard to handle in high volume,” he said. “You can’t test every truckload, or if you do, you are only going to unload 20 trucks in a day.” By comparison, corn processors in Iowa unload 400 or more trucks a day.

BIOFUEL IMPACTS

Ethanol makers already are feeling the impact. Turning corn into ethanol creates a byproduct called distillers dried grains (DDGs), which is sold as animal feed. With fuel prices low, the DDGs can boost profitability.

But the refining process triples the concentration of mycotoxins, making the feed byproduct less attractive. DDG prices in Indiana fell to $92.50 per ton in February, the lowest since 2009, and now are selling for $97.50 per ton, according to USDA.

Many ethanol plants are testing nearly every load of corn they receive for the presence of vomitoxin, said Indiana grain inspector Doug Titus, whose company has labs at The Andersons Inc, a grain handler, and energy company Valero Energy sites.

The Andersons in a February call with analysts said vomitoxin has hurt results at three of its refineries in the eastern U.S. “That will be with us for some time,” Andersons’ chief executive Pat Bowe said.

Missouri grain farmer Doug Roth, who put grain into storage after last year’s wet harvest, has seen a few loads of corn rejected by clients who make pet food after the grain tested positive for low levels of fumonisin, a type of mycotoxin.

Roth said he paid to reroute the grain to livestock producers in Arkansas, who planned to blend it with unaffected grain in order to mitigate the effect of the toxins.

“As long as this doesn’t become a widespread problem, we’re all fine,” said Roth, who said toxins have shown up in less than 1 percent of the grain loads he has sold.

U.S. farmers with clean corn are reaping a price bump. A Cardinal Ethanol plant in Union City, Indiana, is offering grain sellers a 10-cent per bushel premium for corn with less than one-part-per-million (ppm) or less of vomitoxin in it, according to the company’s website.

(Additional reporting by Karl Plume and Julie Ingwersen in Chicago; Editing by Matthew Lewis)