Death by a Thousand Cuts

Donald Trump has declared war. Not on North Korea; not on ISIS or Iran. Certainly not on Russia.

Donald Trump has declared war on the Food Safety Modernization Act.

Trump has not asked Congress to repeal the act or to void its regulations. He knows that would not happen. Instead, he has launched a stealth attack via the budgetary process. An attack on the underpinnings of the country’s food safety enforcement system.

Last week, the Trump White House submitted its budget proposal to Congress. Buried within a single line of the more than one thousand-page budget was the following information:

Foods Program
2016 Actual spending: $1,002,000,000
2017 Estimated spending: $985,000,000
2018 Proposed spending: $910,000,000

That’s correct. Spending on food safety activities under Trump is already on the decline and, if he has his way, will continue to decrease year by year until the Food Safety Modernization Act is nothing but an empty shell. Emasculated due to lack of funding.

How does this compare with the previous administration’s funding? Since the 2011 enactment of the Food Safety Modernization Act, funding for the Foods Program has increased year over year at least in line with inflation, except for 2013 (the year of the infamous budget sequester – the 10% across-the-board cut to all discretionary spending programs).

Actual Spending on Foods Program
(Inflation-adjusted value of 2011 spending in brackets for comparison)
2011: $836,244,000
2012: $866,920,000 ($853,550,000)
2013: $796,638,000 ($866,052,000)
2014: $882,814,000 ($880,101,000)
2015: $903,340,000 ($881,146,000)
2016: $1,002,000,000 ($892,262,000)
2017 (est’d): $985,000,000 ($909,054,000)

We were already nearly four months into the fiscal year by the time Trump’s occupation of the Oval Office began, mitigating his impact on the Foods Program spending for 2017. However, his budget proposal for 2018 will reduce spending on the FDA’s Foods Program to less than the actual dollars spent in 2011, when adjusted for inflation.

The Animal Drugs and Feed Program, which encompasses approval of veterinary drugs and enforcement of pet food safety, fares even worse.

Animal Drugs and Feed Program
2016 Actual spending: $159,000,000
2017 Estimated spending: $158,000,000
2018 Proposed spending: $108,000,000

The Animal Drugs and Feed Program has been the runt of the FDA litter for many years, its year-over-year funding having failed to keep up with inflation more often than not. Yet, in an age when pet food safety is more important to more people than ever before, Trump has proposed to cut the budget for this program by 32% in real dollars and by 38% in inflation-adjusted dollars (based on 2011 dollars).

Spending on the Animal Drugs and Feed Program has not been this feeble since 2008.

Actual Spending on Animal Drugs and Feed Program
(Inflation-adjusted value of 2011 spending in brackets for comparison)
2011: $158,771,000
2012: $156,909,000 ($162,057,000)
2013: $147,774,000 ($164,430,000)
2014: $164,313,000 ($167,098,000)
2015: $175,024,000 ($167,296,000)
2016: $159,000,000 ($169,407,000)
2017 (est’d): $158,000,000 ($172,595,000)

Other federal departments and agencies are not immune to the disease of deregulation by financial starvation. The Centers for Disease Control and Prevention, the Environmental Protection Agency, and others too numerous to list here also are affected. Trump’s war on government regulation is unrestricted. And he is using the budget process as his primary weapon.

It is not a coincidence that I revived eFoodAlert when Trump took office. In the absence of robust and well-funded FDA enforcement programs, it is up to each one of us to provide the necessary vigilance. To recognize and report food safety issues. And to raise our voices in support of the regulatory and enforcement activities that are the essential underpinning of the Food Safety Modernization Act.

Remember Peanut Corporation of America. Remember De Coster Egg Farms. Remember the illnesses and deaths that resulted from the cavalier attitudes of the principals in both companies. Lack of enforcement breeds lack of compliance.

Trump has declared war on clean water, clean air, and food safety. It is time to fight back.

Evanger’s Blames Supplier, FDA, for Pentobarbital in Dog Food

FDA says beef suppliers are not registered; Evanger’s hints at expanded recall

Breaking news: Evanger’s reveals presence of horse DNA in its Hunk of Beef dog food in a Wednesday letter to its customers. The company will recall all of its Hunk of Beef, Braised Beef Chunks with Gravy and Against the Grain Pulled Beef. The formal recall announcement will be issued this week.

Consumer complaints continue as the FDA digs deeper into operations at Evanger’s pet food after discovering evidence that none of the company’s meat suppliers are registered with USDA. Evanger’s owners blamed their suppliers and the FDA in the wake of findings that their dog food contains a barbiturate used to euthanize animals.

At least one dog has died and at least four others required medical attention after eating Hunk of Beef canned dog food from Evanger’s Dog & Cat Food Company Inc., which is owned by the Sher family. Evanger’s and Nutripack LLC, another pet food company owned by members of the same family, have recalled certain lots of certain flavors of their canned dog food.

“The guilty party has turned out to be one of our most trusted meat suppliers. A USDA-APHIS inspected supplier who we had done business with for over 40 years, and whose plant we had visited numerous times over the years,” said Evanger’s owners Holly and Joel Sher in an online statement posted Sunday. “We have taken it upon ourselves to lead the campaign to force the FDA to put an end to allowing drugs like pentobarbital to enter the raw material stream and contaminate our pets’ food and endanger their lives.”

Officials with the Food and Drug Administration do not agree with the company’s contention that the agency is responsible for the pet food being contaminated.

“The detection of pentobarbital in pet food renders the product adulterated in violation of the Federal Food, Drug, and Cosmetic Act. Therefore, it is not acceptable to use animals euthanized with a chemical substance in pet or animal foods,” an FDA spokesperson said Tuesday.

“It is the responsibility of the animal protein ingredient suppliers to implement practices at their facilities to ensure that euthanized animals are either not accepted at the facility, or to determine how they died and ensure euthanized animals are segregated from animal protein going for animal food use.

“Further, it is the responsibility of the pet food manufacturer to ensure that the food they produce is safe for consumption and properly labeled. One way that a manufacturer can do this is by taking steps to verify the identity and safety of the ingredients they receive from their suppliers.”

During the course of their investigation, FDA inspectors discovered a bill of lading from Evanger’s supplier, which listed “Inedible Hand Deboned Beef – For Pet Food Use Only. Not Fit For Human Consumption.”

While FDA cannot reveal the identity of the supplier, an agency spokesperson described it as one that, “…provides materials from animals that are not fit for the human food supply, for a variety of reasons.”

Evanger’s sources the meat for its pet food from more than one supplier. According to the FDA spokesperson, the agency’s “… preliminary assessment indicates that none of these suppliers are USDA-FSIS registered facilities.”

Those findings are in direct contrast to statements from Evanger’s and Nutripack LLC about their pet foods, which they say are made with human-grade food. FDA inspectors also found incomplete information on Evanger’s brand and Nutripack’s Against the Grain brand production records.

According to FDA, inspectors were unable to determine from company records whether any of the beef that was used in the recalled Evanger’s and Against the Grain production lots was also used in any other products. In a letter to its customers released Feb. 21, Evanger’s indicated the recall could be expanded to include all products containing chunk beef, “out of an abundance of caution.”

The investigation so far

In a Friday consumer advisory, the FDA cautioned the public not to feed the recalled Evanger’s and Against the Grain canned dog food products to their pets. The products in question were recalled on Feb. 3 and Feb. 9 by Evanger’s Dog & Cat Food Company Inc. and Against the Grain, respectively, after pentobarbital was confirmed in samples of both products.

In conjunction with the advisory, FDA released two Inspectional Observation reports — Form 483 reports — which detailed the conditions found by the agency’s inspectors during visits to Evanger’s production facility in Wheeling, IL, and to the facility belonging to Nutripack LLC in Markham, IL.

The Wheeling operation had last been inspected by FDA in November 2012. According to a spokesperson with FDA, the Illinois Department of Agriculture performed an inspection in 2016 and classified the Wheeling facility as ‘No Action Indicated.’ However, the plant was not operating at the time, and the inspector was unable to observe the normal day-to-day activities. Nutripack had not been inspected either by the state or by the FDA prior to February 2017.

The USDA’s Food Safety and Inspection Service (FSIS) is the federal agency tasked with oversight and inspection of slaughterhouses and meat processing operations. To be deemed “Fit for Human Consumption,” any meat that enters interstate commerce must have been produced under USDA-FSIS supervision. Slaughterhouses and meat processing operations that do not engage in interstate commerce come under the supervision of the department of agriculture in their home state.

Evanger’s is a private company, incorporated in Illinois. Its President and Agent of Record is Holly Sher, who owns the business together with her husband, Joel Sher.

Nutripack is a Limited Liability Company registered in Illinois. Its Agent of Record is Brett Sher, son of Joel and Holly Sher. Nutripack is managed by Sher Services Company Inc. Joel A. Sher is both the agent of record and the president of Sher Services, while Holly Sher is the secretary. The Against the Grain trademark is registered to Chelsea Sher, daughter of Joel and Holly Sher. Chelsea Sher also is listed as Secretary of Evanger’s.

In their online letter Sunday, the Sher family’s reference to their supplier having been “USDA-APHIS inspected” suggests they may not understand what agencies have jurisdiction over their pet food operations.

According to the USDA website the primary role of APHIS (Animal and Plant Health Inspection Service) in the U.S. food safety network of agencies “is to protect against plant and animal pests and diseases. APHIS also administers the Animal Welfare Act and carries out wildlife damage management activities.”

On the other hand, according to USDA, the FSIS is “responsible for ensuring the safety and wholesomeness of meat, poultry, and processed egg products and ensures that it is accurately labeled.”

As its investigation continues, FDA reports it has received additional complaints from consumers who fed Evanger’s Hunk of Beef to their dogs, in some cases exclusively.

As consumers tend to throw out or recycle empty cans, obtaining specific lot number information has been difficult. The agency continues to encourage consumers to report problems with Evanger’s products through the Safety Reporting Portal or by contacting a Consumer Complaint Coordinator. Additional information is available on the FDA web page, How to Report a Pet Food Complaint.

This story first appeared on Food Safety News and is reposted here with permission.

FDA Confirms Pentobarbital in Dog Food

Pet owners warned to avoid certain Evanger’s and Against the Grain dog food

FDA is advising pet owners and pet caretakers not to feed their pets with certain lots of Evanger’s and Against the Grain dog food after confirming the presence of the euthanasia agent pentobarbital in both products.

Following discussions with FDA, Evanger’s announced a voluntary recall on February 3, 2017 of five lots of its 12-ounce Hunk of Beef canned dog food, all with an expiration date of June 2020: 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB. On February 9th, Against the Grain voluntarily recalled lot #2415E01ATB12 BEST DEC 2019 of its Grain Free Pulled Beef with Gravy dog food after the agency detected pentobarbital that product. The Pulled Beef with Gravy was manufactured in the same facilities as Evanger’s products and using beef from the same supplier.

In addition to the presence of pentobarbital, FDA reports a bill of lading from Evanger’s supplier of ‘Inedible Hand Deboned Beef – For Pet Food Use Only. Not Fit for Human Consumption’. This is despite Evanger’s claim that the beef in its Hunk of Beef product came from a ‘USDA approved’ supplier. FDA also has determined that the supplier’s facility does NOT have a grant of inspection from USDA’s Food Safety and Inspection Service. The meat from the supplier does not bear a USDA inspection mark and would not be considered human grade. Lab testing by USDA-FSIS of Evanger’s Hunk of Beef confirmed that the meat in the product was beef.

Other issues cited in a preliminary investigation report (FDA Form 483) released today by FDA include evidence of unsanitary conditions, inadequate refrigeration, improper storage, and inadequate control of ambient temperature during hand-packing operations at Evanger’s Wheeling, IL facility and unsanitary conditions and ‘avian activity’ at its Markham, IL manufacturing location.

FDA’s investigation is ongoing and will include examination of the suppliers of beef to Evanger’s and Against the Grain to determine the source of the pentobarbital. The agency is also coordinating with USDA to address possible areas of shared jurisdiction.

Consumers with cans of the recalled product should refer to the Evanger’s and Against the Grain recall notices for information on returning the product.

This article first appeared on Food Safety News and is reposted here with permission.