FDA Officials Discuss Phase Two of FSMA Implementation


Although still in the phase 1 rulemaking stage of implementing the Food Safety Modernization Act (FSMA), the Food and Drug Administration is planning for moving forward with “phase 2” which will involve training and compliance activities.

FDA Deputy Director for Regulatory Affairs, Roberta Wagner, discussed the agency’s current thinking about how it will tackle the next implementation phase, in an August 26 webinar sponsored by the Food Safety Preventive Controls Alliance (FSPCA). FSPCA is a collaborative program of the Illinois Institute of Technology, industry, academic and government stakeholders which is developing a core curriculum, training and outreach programs for companies producing human and animal food in compliance with FSMA’s preventive control provisions.

A similar presentation, sponsored by the Produce Safety Alliance (PSA), was made in early July by Kathy Gombas, who has the lead role for FSMA change management in FDA’s Center for Food Safety and Applied Nutrition (CFSAN). PSA is a collaborative project between Cornell University, USDA and FDA that will provide training and education on current best practices and guidance, and on the regulatory requirements for produce.

In Phase 2, FDA will be investing in regulatory training to promote consistent inspections. Because not every inspector will be an expert in the products being inspected in every establishment, inspectors will have access to subject matter experts in FDA headquarters who can answer questions that arise. The inspectors will be assessing a company’s “food safety culture” which will determine what approach the agency will take with that facility, using a risk-based approach, the FDA officials explained

FDA plans to facilitate industry implementation of preventive practices by expanding its oversight toolkit to encourage voluntary compliance. This expanded toolkit will include:

  • Commodity and sector-specific guidance;
  • Education, outreach and technical assistance;
  • Regulatory incentives for compliance.

So, a company’s food safety culture will guide FDA’s regulatory approach, using targeted, risk-based inspection models. In addition, the agency will be conducting more sampling, although the sampling will focus on fewer commodities, the agency says.

FDA expects to “educate before regulating,” providing technical assistance and considering work performed by public-private partners. For produce, for example, it plans to conduct targeted on-farm surveys and inspections and to “deploy a cadre of specialized produce safety experts for on-farm activities, to encourage voluntary compliance.”

For Phase 2, the agency has created a steering committee that oversees three workgroups: on Preventive Controls in Food and Feed Facilities, Produce Safety Standards, and Import Oversight. In addition, it plans to set up a Regulator Technical Assistance Call Center, to allow for inquiries and responses while inspectors are at the inspection sites.

The agency also plans to continue stakeholder engagement and to work with multiple partners to foster industry understanding of final rules/guidance and to facilitate high rates of voluntary compliance.

The FSPCA is developing a training curriculum consistent with FSMA. This curriculum will be publicly available when the final preventive controls rule is published. The Produce Safety Alliance is also developing a training curriculum and expects to be in the train-the-trainer phase in the fall or early winter.

Training and education are key to the success of FSMA, not only for the regulated industry but for the FDA regulators who are charged with inspections and enforcement of the sweeping new rules. There is concern within the food industry that the FDA will not be prepared when the final rules take effect leading to inconsistent interpretation and enforcement of the law. Just as the industry is required to employ “qualified individuals” to oversee food safety plans, it has been suggested that the FDA require inspectors to be “qualified” through formal training before performing compliance activities under FSMA.

FDA to Enforce New Infant Formula Rules Immediately

By EAS Senior Consultant Allen Sayler

An estimated one million infants (roughly one-third) in the United States are fed infant formula from birth, and by the time they are three months old, about 2.7 million (roughly two-thirds) rely on formula for at least part of their nutrition. US-produced and packaged infant formula is in high demand internationally because of its excellent safety and nutrition record and because of the concerns raised by the melamine scandal in China and the tainted milk powder incident in New Zealand.

Based on a number of unfinished infant formula regulations and the need to update existing regulations, FDA published an interim final rule on February 10, 2014 and announced on June 9, 2014 that it was finalizing this rule, intended to set standards for the manufacture of infant formula either processed in the US or intended to be marketed in the US. The final rule is similar to the interim rule with a few modifications based on comments received by the agency after the February 2014 publication.

While infant formula processors have been applying many of the newly required Good Manufacturing Practices (GMPs) as part of their own internal product safety and quality programs, these finalized GMPs and other parts of the new rule now become federally enforceable. As a result, the industry requested that FDA delay enforcement to allow the industry to become familiar with and implement these new requirements. FDA rejected industry requests, setting a date of September 8, 2014 for manufacturer compliance. It is hoped that for the rest of 2014, FDA will instruct its field inspection/auditing staff to be reserved in their enforcement to allow the industry time to adapt to the vast new regulation, but there is no certainty of this.

Below is a reference table with links to additional information as well as the complete and final GMPs for infant formula processing.

The final rule applies only to infant formulas intended for use by healthy infants without unusual medical or dietary problems. Under the final rule, some points addressed include:

  • Current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter.
  • A requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth (of infants).
  • A requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.
  • A few other existing requirements:
  • “Use by” date. This is the date after which a package or container of infant formula should not be fed to infants. It indicates that the manufacturer guarantees the nutrient content and the general acceptability of the quality of the formula up to that date. FDA regulations require this date to be specified on each container of infant formula.
  • Storage. Manufacturers must include instructions on infant formula packaging for its handling before and after the container is opened. They must also include information on the storage and disposal of prepared formula.

FDA does not approve infant formulas before they can be marketed. However, all formulas marketed in the United States must meet federal nutrient requirements, which are not changed by the new rule. Infant formula manufacturers are required to register with FDA and provide the agency with a notification prior to marketing a new formula. Proof of compliance with existing and new requirements will be required when FDA investigators conduct their annual inspections/audits of all infant formula processors selling product in the US market. In addition, FDA also collects and analyzes product samples. Based on the inspections/audits and sampling, if FDA believes that an infant formula presents a risk to human health, the manufacturer of the formula must conduct a recall.

Additional references regarding the FDA requirements for processing infant formula for the US market include:

  • 21 CFR 106 Infant Formula Quality Control Procedures
  • 21 CFR 106.100 Records and Reports Regulations
  • 21 CFR 107.3 – 107.30 Infant Formula Labeling Requirements
  • 21 CFR 107.50 Exempt Infant Formulas
  • 21 CFR 107.100 Nutrient Requirements for Infant Formulas
  • 21 CFR 107.200 – 107.280 Infant Formula Recall Requirement

If you have additional questions regarding this new extension of the existing US FDA infant formula regulation or experiences with FDA enforcement of this new rule, please feel free to contact Mr. Sayler at asayler@easconsultinggroup.com.