The “budget blueprint" released in March by President Donald Trump proposed deep spending cuts, including nearly an 18 percent decrease for the Department of Health and Human Services (HHS), but the document largely failed to assess the impact on FDA and its ability to safeguard the nation’s food supply.
Trump’s plan reflects an effort to bolster defense spending by US$54 billion, while making offsetting reductions elsewhere that would impact various federal agencies overseeing such areas as education, agriculture, and housing and urban development.
The budget blueprint only covers discretionary funding proposals and reflects an effort not to add to the nation’s $20 trillion in debt.
“Every agency and department will be driven to achieve greater efficiency and to eliminate wasteful spending in carrying out their honorable service to the American people," the president said in a statement accompanying the release of his budget blueprint.
The 53-page document, issued by the White House’s Office of Management and Budget (OMB), proposed a $69 billion budget for HHS for fiscal year 2018 (FY18)a 17.9 percent or $15.1 billion decrease from the 2017 level funded under a continuing resolution.
FY18 begins Oct. 1.
FDA is within HHS, but Trump’s plan sheds little light on how FDA would be impactedother than a request to increase by $1 billion medical product user fees.
Under the HHS heading, OMB made no mention of food safety.
Steven Grossman, deputy executive director of the not-for-profit Alliance for a Stronger FDA (Alliance), described Trump’s blueprint as a “very cursory document that was put together for the purpose of basically showing where the president would move money around from non-defense to defense."
Whatever your program is, you can’t read anything into the fact that it’s not mentioned," he said in a phone interview.
FDA and USDA Food Safety Budgets
The requested cuts to HHS’ budget, nevertheless, leave stakeholders wondering if and how food safety will be impacted at FDA.
In FY16, excluding user fees, FDA received $987 million for its food budget authority, according to the Alliance, which noted former President Barack Obama requested a food budget of $1.013 billion for FY17.
“Certainly, there needs to be food safety, but the question becomes … how much money is going to be devoted to food safety, and how much more money will be given to food safety," asked Mike Greene, vice president of government relations with the Council for Responsible Nutrition (CRN), a trade association representing the dietary supplement and functional food industries.
The pending funding issues at FDA haven’t escaped the attention of Jaydee Hanson, senior policy analyst with the nonprofit public interest group Center for Food Safety.
“We’re quite concerned there already wasn’t enough money to implement the Food Safety Modernization Act [FSMA]," said Hanson, whose employer sued FDA for missing deadlines under the sweeping law signed by Obama in 2011.
Unless we get serious about food safety being a part of homeland security, it will likely mean another major outbreak of unsafe food before we get the money back," Hanson said later in the same phone interview.
The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) may feel more certain about its funding than, say, FDA’s Center for Food Safety and Applied Nutrition (CFSAN). Trump has requested $17.9 billion for USDA, a $4.7 billion or 21 percent reduction from the 2017 continuing resolution level.
However, OMB noted the budget will fully fund an agency that is responsible for ensuring the safety of the nation’s meat, poultry and egg products: FSIS. Obama requested $1.030 billion for FSIS in his FY17 budget, according to a USDA official’s testimony last year on Capitol Hill.
“The investments that Congress has made in FSIS are having a positive impact on food safety that will continue to unfold in significant ways," Al Almanza, former deputy under secretary for food safety at USDA, testified last year before the House Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. “For instance, we have continued to modernize how we do inspections, and, as a result, we have improved our ability to protect the health of the American public."
Bill Marler, an expert in food safety whose law firm Marler Clark LLP represents victims of food poisoning, was pleased the president requested full funding for FSIS. However, he wondered whether Trump’s budget would cut or stabilize funding at FDA for its responsibilities under FSMA.
Full Budget Proposal Pending
Grossman said the president’s full budget is expected to be released in May and should include more details, including requested funding at FDA offices like CFSAN.
“There should be enough detail that you can say, ‘This is how much they’re spending on food safety. This is how much they’re spending on dietary supplements,’" Grossman pointed out. In a recent update, the Alliance noted the president’s request for FDA alone typically includes several hundred pages of details.
It’s up to the appropriations subcommittees and committees in Congressand ultimately the House and Senateto agree on a budget before a government spending bill is sent to the president for his signature, Grossman noted.
“Congress will make the final decisions. However, regardless of the actual numbers in the [president’s] proposal, the tone and direction threatens FDA’s appropriation and the agency is at risk," the Alliance warned in a March 3 update. “We need to advocate for FDA to be one of those protected programs that are not subject to a 10-15% cut because they are considered a national priority."
The government is currently operating under a continuing resolution that ends in April, and Congress still has to agree to fund the government between April 28 and Sept. 30, 2017, Grossman said. (In the budget blueprint, OMB stated most appropriations bills for 2017 were not voted on in Congress).
Funding Implementation of FSMA
In a recent letter to leaders of the House and Senate appropriations committees, Cargill Inc., The Coca-Cola Co., Campbell Soup Co., and 18 other companies and associations requested an increase in funding for FDA’s food safety budget.
“In order to maintain consumer confidence in the safety and integrity of America’s food supply and to reduce the number of foodborne illnesses, it is important that FDA … has the training, technical assistance and infrastructure in place to implement FSMA effectively," the March 15 letter asserted. “Our commitment to food safety is steadfast and we need a strong FDA as our partner to fully implement FSMA and to play its proper role in ensuring the safety of the nation’s food supply.
Trump’s policiessuch as his executive order calling for the repeal of two existing regulations for each new one adopted, a hiring freeze and his requested budget cutshave raised concerns that his federal agencies will be handicapped in their abilities to govern.
Even before Trump was president, his campaign reportedly highlighted regulations to be nixed, including “The FDA Food Police, which dictate how the federal government expects farmers to produce fruits and vegetables and even dictates the nutritional content of dog food."
“The rules govern the soil farmers use, farm and food production hygiene, food packaging, food temperatures and even what animals may roam which fields and when," Trump’s campaign statement continued, The Hill reported in a Sept. 15, 2016 article. "It also greatly increased inspections of food 'facilities,' and levies new taxes to pay for this inspection overkill."
According to published reports, the fact sheet was later removed from the campaign website.
Marc Sanchez, an attorney, regulatory consultant and adjunct professor at Northeastern University, said it could be problematic if, for example, FDA isn’t adequately staffed to inspect facilities for compliance with FSMA.
“That could be a concern that the FDA is not being as proactive and preventative as FSMA … envisions," said Sanchez of the law firm Contract In-House Counsel & Consultants LLC, based in Washington and Charlotte, North Carolina.
FDA has adopted seven major regulations under FSMA, including its rules governing preventive controls for human food, produce safety and foreign supplier verification programs (FSVP).
Large companies have been required to comply with a number of the FSMA regulations since 2016including the human food preventive controls ruleand several deadlines for compliance are coming up in 2017, 2018 and 2019 for the entire industry, according to a reference sheet posted online by the Grocery Manufacturers Association.
Sanchez noted ambiguity on whether Trump’s executive order aimed at reducing regulations affects guidance documents as well. FDA often releases guidance documents to provide additional clarification for industry regarding their obligations under the law and applicable regulations, such as FSMA and its “seven pillars" or rules.
Impact on Dietary Supplements
Greene of CRN said his organization would be advocating for increased funding to support FDA’s Office of Dietary Supplement Programs (ODSP). In late 2015, FDA’s Division of Dietary Supplement Programs was elevated to an office, but the move reportedly hasn’t resulted in a surge in funding.
In FY16, ODSP received a budget of $4.6 million, the agency said in response to questions during a congressional appropriations hearing. The budget includes 26 approved positions, FDA noted. In FY17, the proposed budget for ODSP was $5.9 million, the agency said.
“We’re still operating on a division budget, and so it’s going to be very difficult in this current environment to encourage more funding," Greene acknowledged, “but it’s something we believe is necessary."
He said there is a need for “reasonable regulation" of supplements.
“Our consumers take our products and put them into their bodies, and we want to make sure above all that the products are safe, made to high-quality standards and [are] beneficial," Greene declared, “and we need an active FDA to do this."