Comments to FDA on Food Safety Modernization Act Implementation

December 15, 2014

Margaret Hamburg, M.D.
U.S. Food and Drug Administration (FDA)
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Re: Supplemental Notices of Proposed Rulemaking FDA-2011-N-0921 ("Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption") and FDA-2011-N-0920 ("Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food")

Dear Dr. Hamburg:

The Academy of Nutrition and Dietetics is pleased to comment on FDA's amended proposed rules "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption" (hereinafter, "Produce Rule") (FDA-2011-N-0921) and "Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food" (hereinafter, "Preventive Controls Rule") (FDA-2011-N-0920), (together, the "Amended Proposed Rules") published in the Federal Register September 29, 2014. The Academy is the world’s largest organization of food and nutrition professionals, representing more than 90,000 registered dietitian nutritionists (RDNs),1 registered dietitians (RDs), dietetic technicians, registered (DTRs), and advanced-degree nutritionists. Every day we work with Americans in all walks of life—from prenatal care through old age—providing nutrition care and conducting nutrition research. We are committed to improving the nation's health and meeting nutrition needs through the lifecycle and play a major role in food safety education and research.

Position of the Academy

It is the position of the Academy that the public has the right to a safe food supply and to that end we support the ongoing collaboration among food and nutrition professionals, academics, representatives of the agricultural and food industries, and appropriate government agencies. Reducing foodborne illnesses is one of the objectives of Healthy People 20202 and food safety is recommended in the 2010 Dietary Guidelines for Americans.3 Every year, over 48 million Americans get sick, 128,000 are hospitalized, and 3,000 die from foodborne illnesses, according to the Centers for Disease Control. The Economic Research Service of the U.S. Department of Agriculture in 2000 estimates that five bacterial pathogens result in over $6.9 billion in annual costs: Campylobacter, Salmonella, Listeria monocytogenes, E. coli O157:H7, and E. coli non-O157:H7 STEC.4 In light of the health risks and financial costs associated with foodborne illness and to assist congressional efforts to ameliorate them, Academy adopted three principles for federal food safety authority:

  • Food authority should be science-based and consistently applied to all foods regulated by all agencies for domestic and imported foods. The Academy supports the concept of a single food safety agency to protect the public’s health.
  • Food authority should be collaborative across national, state, and local agencies and between government and industry partners to foster more robust, consistent, accurate and timely communication and data sharing that leads to efficient and effective decision-making processes.
  • Food protection should include statutory authority by government regulatory agencies for traceability and recall, supported by research, epidemiology and inspection programs.

The Food Safety Modernization Act (FSMA) was signed into law in 2011 to better protect public health by helping to ensure the safety and security of the food supply. The Amended Proposed Rules implementing FSMA effectuate the Academy's food safety principles as appropriate, balanced, science-based examples of industry and government working collaboratively to improve our nation's food safety regime, contribute to a decrease in foodborne illness outbreaks, ensure confidence in our food purchases, and effectively balance industrial efficiency with public health.

The Academy commends FDA's focus on prevention, its rules on worker health and hygiene, and its efforts to facilitate a simplified, effective traceability process through attribution. FDA appropriately enhances its "integrated approach" in the Amended Produce Rule to support and encourage diversified farming operations. The Academy supports the proactive, systematic, evidence-based approach to food safety assurance in the Amended Proposed Rules and appreciates FDA's thoughtfulness in supplementing the original proposed rules in response to public comments received during the original comment period.

Defining Farms and Facilities

The Academy supports FDA’s supplemental proposal to more clearly show a brightline difference between farm and facility definitions to help farmers understand to which category they belong and which standards they must meet. Direct-to-consumer sales at farmers markets, mobile markets, and community supported agriculture systems (CSAs) are important venues for providing access to fresh, healthy, affordable food in urban and rural communities alike and enable many small and mid-sized producers to remain financially viable. The Academy recognizes that FSMA intended CSAs and other direct-toconsumer entities to be included as retail food establishments (P.L. 111-353, § 102(c)(1)(B)), and the Amended Proposed Rules now clearly reflect this statutory mandate such that CSAs, farmers markets, and roadside stands will not be deemed facilities in the final rule.

FDA's clarification is also necessary for food hubs and aggregators of locally and regionally sourced fresh produce. The Amended Preventive Controls Rule should not be so onerous or costly so as to hinder growth or force closings in the aggregation sector, and the Academy is pleased that FDA is proposing evidence-based definitional changes in the Amended Proposed Rule to prevent farms that merely pack and hold someone else's produce from being deemed a facility

Clarifying Exemption for Smallest Farms

Consistent with FSMA's intent (P.L. 111-353, § 105(a)(a)(3)(A)), the Academy applauds FDA's supplemental proposal that the gross sales exemption for the smallest farms should apply only to produce covered under the Amended Produce Rule, rather the gross sales of all food. This distinction will provide some flexibility for beginning farmers, non-produce farmers seeking to diversify farm operations, and family farmers with diversified operations.

Support Organic and Conservation Practices

The Academy seeks to ensure sustainable, scientifically-supported conservation practices can continue under the Amended Proposed Rules to help provide the safe, healthy foods ascribed to them. As consumer consumption of organically grown foods increases, the use of nonchemical fertilizers may pose problems with microbial contamination associated with animal manure. Technologies will need to be developed and regulatory standards set to reduce this potential source of environmental and food contamination. The Academy supports the Amended Proposed Rules to the extent they no longer "conflict with or duplicate the requirements of the national organic program [NOP] established under the Organic Food Production Act of 1990..." (P.L. 111-353, § 105(a)(a)(3)(E)). Specifically, the Academy supports the Amended Produce Rule's application schedules on the use of natural compost and manure while still providing sufficient assurances that microbial contamination is not occurring on sustainable and organic farms. In addition, FDA should more strongly support on-farm conservation practices by incorporating positive concepts and statements from the preamble of the final Produce Rule into the regulatory text itself to ensure that the standards incorporate flexible conservation practice.

Agricultural Water Standards

FSMA mandates that implementing regulations "include, with respect to growing, harvesting, sorting, packing, and storage operations, science-based minimum standards related to...water" (P.L. 111-353, § 105(a)(a)(3)(B)), which FDA originally satisfied by adopting the Environmental Protection Agency's recreational water standard. Recognizing the statutory requirement to implement science-based agricultural water standards and noting the fact the FSMA implementation has already been delayed beyond its mandated deadline, the Academy supports the supplemental changes in the Amended Proposed Rules to facilitate a safe, scientifically sound process and standard for agricultural water.

Environmental and Product Testing

The Academy believes that environmental testing can be valuable in determining whether a facility's sanitation measures have been appropriately followed, and may be critical in situations where the hazard of contamination of food with an environmental pathogen were likely to occur. Product testing—if scientifically sound—could provide additional assurance that no contamination is present. Before FDA includes requirements for final product testing, it should publish the evidence demonstrating its effectiveness and assessing the economic impact of a mandate.

Improved Federal Authority through Partnerships and Guidance

The Academy supports FDA's commitment to provide updated guidance and technical assistance that incorporates technological advancements, identifies critical operational parameters (and how to test them), and information about emerging pathogens and pathogens finding new niches. FDA should provide stakeholders with updated data on an ongoing basis that could materially change the scientific basis for the various standards promulgated in the Amended Proposed Rules. By working together, FDA, farmers, industry, and other food safety experts such as RDNs can continue to improve the proposed food safety regime and ensure effective training of FDA field personnel and inspectors.

The Academy appreciates the opportunity to comment on the Amended Proposed Rules implementing FSMA and hope you will look towards the Academy and our members' expertise as you begin implementation and oversight of these new food safety initiatives. Please contact either Jeanne Blankenship at 202/775-8277, ext. 1730 or by email at or Pepin Tuma at 202/775-8277, ext. 6001 or by email at with any questions or requests for additional information.

Jeanne Blankenship, MS RDN
Vice President, Policy Initiatives and Advocacy
Academy of Nutrition and Dietetics

Pepin Andrew Tuma, Esq.
Director, Regulatory Affairs
Academy of Nutrition and Dietetics

1 The Academy recently approved the optional use of the credential "registered dietitian nutritionist (RDN)" by "registered dietitians (RDs)" to more accurately convey who they are and what they do as the nation's food and nutrition experts. The RD and RDN credentials have identical meanings and legal trademark definitions.

2 US Department of Health and Human Services. Food safety. Healthy People 2020 Web site. Accessed July 23, 2013.

3 US Departments of Health and Human Services and Agriculture. Dietary Guidelines for Americans, 2010. Web site. Accessed July 23, 2013.

4 US Department of Agriculture Economic Research Service. Foodborne Illness website. Accessed November 7, 2013