FDA’s FSMA Funding Boost

FDA’s implementation of the Food Safety Modernization Act (FSMA) is off to a strong start in 2016, with an injection of $104.5 million in additional funding from Congress in the omnibus appropriations bill passed December 18. The substantial increase in funding for fiscal year 2016 will increase the agency’s ability to advance plans for training and outreach relating to the five FSMA final rules released to date and the two additional final rules anticipated this year.

FDA plans to “work collaboratively with companies that are making a good faith effort to produce safe products and meet regulatory requirements,” noted Deputy Commissioner for Global Regulatory Operations and Policy, Howard Sklamberg, and Deputy Commissioner for Foods and Veterinary Medicine, Mike Taylor, in a December 21 post on the FDA Voice blog site.

But the agency won’t be giving out free passes to bad actors. It is “strongly committed to working with companies that take their safety responsibilities seriously – and equally committed to dealing strongly with those that don’t,” Sklamberg and Taylor said.

Over the past two years, FDA criminal enforcement has resulted in 407 cases opened, 348 arrests, 305 convictions, and more than $694 million in fines and restitutions, they noted.

An important first question for any company committed to compliance with the new FSMA regulations is whether its products are covered or exempted. FDA is currently working on numerous guidance documents to help companies find answers to these and other key questions. The agency is preparing guidance for small or very small businesses on the human food and animal food rules, as well as hazard analysis and preventive controls, environmental monitoring, allergen controls, and validation of process controls for human food. It is also preparing guidance on current good manufacturing practices (CGMPs), hazard analysis and preventive controls, and on human food by-products for use as animal food.

Agency officials are still working on some of the thornier questions for these guidance documents. The additional FY2016 funding from Congress should help the agency commit the resources needed to complete these important compliance tools.

On FDA’s Environmental Assessment Guidance for INDs, BLAs

By EAS Senior Consultant Charles Eirkson

FDA’s Center for Biologic Evaluation and Research (CBER) released new industry guidance in May 2015 on environmental assessments for investigational new drug applications (INDs), biologics license applications (BLAs) and supplements to BLAs.

The guidance includes recommendations on what to consider in assessing whether to submit an environmental assessment (EA) for gene therapies, vectored vaccines, and recombinant viral or microbial products. It also contains recommendations on what to include in an EA and what to expect once an EA is filed.

The guidance, Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant viral or Microbial products, finalized draft guidance issued in June 2014 and it supplements the agency’s 1998 Guidance for Industry: Environmental Assessment of Human Drug and Biologics Applications.

The National Environmental Policy Act (NEPA) enacted in 1969 requires all Federal agencies to address the environmental impact of their actions. But many classes of actions are excluded and do not require an EA or an environmental impact statement (EIS). The CBER guidance considers how to decide whether an EA is needed for INDs and licensing applications, as well as other circumstances. It also lists the information that should be in the EA, including, for example, the substances subject to the proposed action, the potential environmental effects, mitigation measures, and alternatives to the proposed action.

NEPA requires an EA to support any Finding of No Significant Impact (FONSI). If some environmental impact may be expected from an action, NEPA requires an EIS.

The processes for applying NEPA’s provisions are extensively outlined by the Council on Environmental Quality (CEQ) regulations found in 40 CFR Parts 1500-1508. FDA’s regulations for meeting its NEPA obligations are found in 21 CFR Part 25.

Court challenges on NEPA grounds are common and any deviation from the NEPA procedures can result in agency actions not moving forward — including actions on approvals of regulated products. Because of the possibility of a court challenge, all scientific assessments need to be rigorous and credible.

As with all agency guidance, the document reflects the agency’s latest thinking on the subject and it is not mandatory to follow the recommendations. An alternative approach may satisfy the relevant statutes and regulations, but it is a good practice to contact the agency ahead of time to check that any proposed alternative approach would raise any red flags. Environmental documents are reviewed by a limited staff at FDA and they review a lot of documents. Any alternatives from the expected approach requires extra staff time and effort to review and reach a decision.

Other FDA Centers have released separate environmental impact guidance over the years for food additives, human drugs, veterinary drugs and tobacco products, including:

Animal drugs and veterinary products



Human Drugs and Biologics