The National Antimicrobial Resistance Monitoring System Strategic Plan 2011-2015
May 24, 2011
Washington, May 24, 2011 –
Division of Dockets and Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: [Docket No. FDA-2010-N-0620] The National Antimicrobial Resistance Monitoring System Strategic Plan 2011-2015; Request for Comments
Dear Sir or Madam:
The National Pork Producers Council (NPPC) submits, on behalf of its members, these comments on the National Antimicrobial Resistance Monitoring System Strategic Plan. NPPC is a federation of 44 state pork producer organizations and represents the interests of the nation’s 67,000 pork producers. The U.S. pork industry represents a major value-added activity in the agricultural economy and a major contributor to the overall U.S. economy.
NPPC appreciates the collaborative efforts of FDA, USDA and CDC through NARMS to gather data that can be used to strategically approach the issue of antimicrobial resistance in foodborne organisms. It is important for the applicable agencies to work together, as equal partners, in addressing food system issues. While we appreciate and support the intent of the NARMS program, the Strategic Plan 2011-2015 lacks detail on priorities, activities and funding, which makes it difficult to determine how the plan will be implemented.
The Strategic Plan outlines four goals but does not assign a priority to them. The U.S. pork industry feels strongly that the NARMS program must provide statistical sampling of healthy animals, retail meats and humans with enteric illness. This sampling must be robust, statistically designed and reported in a timely manner. Goals 1 and 2 generally address these concerns and should be NARMS’s top priorities. With limited funding for NARMS, Goals 3 and 4 should be reevaluated for their contribution to the mission of NARMS and considered for elimination from the NARMS program.
Below are specific comments on the Goals and Objectives, including questions that need answers from the agencies.
Goal 1: To develop, implement and optimize a shared database, with advanced data acquisition, analysis, and reporting tools
The IT support of a NARMS program is essential but secondary to the sampling and laboratory activities. While NPPC supports having the necessary resources available “(t)o develop, implement and optimize a shared database, with advanced data acquisition, analysis, and reporting tools,” we have questions about how the goal will be achieved:
• How will NARMS integrate the data among partners to allow for comprehensive trend analyses across varied sample sources?
• What types of analyses will NARMS perform, and will they be transparent for stakeholder consideration?
• Will stakeholders that contribute to acquisition of NARMS data have input into the analysis of the data or access to the data with which to make an independent analysis?
• How will the stakeholders access this data?
For NARMS to best serve its stakeholders, it is important for that data be integrated across the partner agencies as trend analysis is dependent on integration across all sample sources. In addition, timely reporting is essential for consideration of potential interventions or other uses of NARMS data. Access to data by stakeholders to allow for independent analyses of specific trends or considerations will enhance the value of NARMS.
Goal 2: To make sampling more representative and more applicable to trend analysis
NPPC considers it important to have a comprehensive understanding of antimicrobial trend analysis from “farm to fork.” Over the years, NARMS has moved away from live animal sampling and focused on retail meat, but to truly be a comprehensive program and to be able to better interpret antimicrobial resistance throughout the food chain, it is necessary for NARMS to also monitor antimicrobial resistant data from representative samples of live animals on-farm and at the packing plant. While the 2011-2015 Strategic Plan proposes “working towards [sic] improving and expanding sampling schemes so that the data will best reflect the U.S. food-producing animal production and distribution system, and capture data on the prevalence of antimicrobial resistance among enteric bacteria along the farm-to-fork continuum,” a live animal sampling scheme currently does not exist and needs to be incorporated.
Similar to the previous goal, Goal 2 and its associated objectives raise a number of questions:
• How does NARMS plan to modify animal sampling to overcome the biases resulting from the current reliance on USDA’s Food Safety and Inspection Service (FSIS) Hazard Analysis and Critical Control Points (HACCP) compliance sampling? In addition to a more statistically valid sampling strategy in the packing plant, live animal sampling on-farm should be considered as one means of overcoming such biases.
• How would live animal sampling be accomplished (geographic representation, production site representation, adequate number of samples)?
• How will sampling be standardized among partners to allow for comprehensive trend analyses?
Additionally, in light of budgetary/workforce constraints and the research (versus monitoring) focus of Objectives 2.4 and 2.5, we do not consider these objectives to be a priority for NARMS.
Further research on the presence of antimicrobial resistance among bacteria in animal feeds and the potential animal health and public health impact is necessary to inform the development of the proposed animal feed surveillance component. Since previous research has demonstrated a disconnect between bacteria found in feed and in the animals consuming the feed, animal feed sampling is of low value to the NARMS mission. Likewise, additional research is needed to
investigate the significance of commensal bacteria as reservoirs of resistance genes that can be transferred to pathogens of public health importance. If the stated mission of NARMS is to “(m)onitor trends in antimicrobial resistance among foodborne bacteria from humans, retail meats, and animals,” the role of commensals in foodborne infection is unknown and likely small. Again, this would be a low value activity in achieving the NARMS mission. If these activities are to be conducted, NPPC believes that funding and responsibility for these objectives should be separate from NARMS.
Goal 3: To strengthen collaborative research projects
The U.S. pork industry recognizes the importance of collaborative research to better inform NARMS programming and appreciates the need of NARMS to be interactive, engaged and responsive to developments in antimicrobial resistance. However, in light of budgetary constraints, resources directed toward this goal are not warranted in the Strategic Plan.
Goal 4: To support international activities that promote food safety, especially those that promote mitigation of the spread of antimicrobial-resistant bacteria and resistance determinants
U.S. pork producers appreciate the value of engaging at the international level and harmonizing surveillance activities to mitigate the emergence of antimicrobial resistance. However, until an effective national plan has been established and Goals 1 and 2 have been achieved, significant resources directed toward this goal are not warranted as part of the Strategic Plan. For example, in fiscal 2010, FDA provided $847,500 to support a collaborative agreement between the WHO and FDA aimed at capacity building in laboratory-based surveillance of foodborne pathogens and disease in developing regions to support the Advisory Group on Integrated Surveillance of Antimicrobial Resistance (AGISAR) and the WHO Global Foodborne Infections Network (GFN). Subject to the availability of funds and successful performance, two additional years of support up to $565,000 per year will be available. At this time, efforts and supporting funds should be focused on achieving proposed Goals 1 and 2.
NPPC thanks FDA, USDA and CDC in advance for considering these comments. We look forward to working closely with you in developing a robust and effective surveillance system that meets the needs of public and animal health.
National Pork Producers Council