Drover's News

PEW Supports FDA’s Biomass Method for Monitoring Antibiotic Use

The PEW Charitable Trusts, long involved in public health and antibiotics policy, encourages the FDA to follow through with its plans to adopt a “biomass method” for measuring and analyzing antibiotic use in food animals.

The FDA proposed adoption of the biomass method in 2017. The animal biomass adjustment uses animal population estimates to provide context for antibiotic sales data, helping explain trends and fluctuations in antibiotic use by accounting for differences or changes in animal populations, such as animal life span, species and production class differences or management practices. The current process reports antibiotic sales, with estimates of use in major food-animal species, but lacks details needed to fully evaluate trends.

According to PEW, FDA has not taken any concrete action to finalize the proposal, even though its five-year plan identifies initiating a biomass method by 2021 as an immediate priority. In an issue statement this week, PEW addresses four concerns over the plan that emerged in public comments following the FDA’s 2017 proposal. The report includes PEW resolutions for addressing each issue, along with specific points on how the biomass method could provide more useful data in the battle against antibiotic resistance.

Issue 1: Antibiotic sales data provide imperfect insights on actual antibiotic use.

Resolution: Antibiotic sales data provide valuable insights into use trends, however, Pew acknowledges the data’s limitations and recognizes the importance of ensuring appropriate analysis and interpretation.

While PEW acknowledges data can be imperfect, the report argues biomass-adjusted sales data are important for three key reasons:

Sales data are well established, useful, and the only publicly available and nationally representative source to estimate total antibiotic use in U.S. food animal production.

Biomass-adjusted sales data provide meaningful insight into antibiotic consumption in animals—and are less likely to be misinterpreted—than sales data alone.

Sales data collection complements, rather than precludes, the collection of actual antibiotic use data. 

Issue 2:  FDA’s proposed approach for calculating biomass is not sufficiently described, lacks transparency, and may slightly overestimate the size of the animal population.

Resolution: Pew agrees that FDA should provide additional details about the proposed biomass calculation and align the method with existing ones to the extent feasible, although ultimately, any one of the proposed methods may be acceptable as long as it is implemented appropriately and consistently used to track changes.

PEW believes the technical issues that stakeholders raised should not detract FDA from swiftly finalizing the biomass method for three key reasons:

Several countries and organizations have successfully established biomass adjustments specific to their unique needs (e.g., comparisons across countries or over time) and country situation, and there is value in developing a U.S.-specific method.

The FDA method can be transparently described and largely aligned with existing methods. 

A comparison of trends is possible with any of the proposed or established methodological choices. 

Issue 3: Inappropriate comparisons with biomass-adjusted sales estimates from other countries may lead to inappropriate conclusions about U.S. antibiotic use.

Resolution: Pew acknowledges the potential risk of inappropriate comparisons, including across different countries and geographic regions.

PEW believes these challenges should not deter FDA from finalizing the biomass adjustment method for three key reasons:

Initiatives are underway to find appropriate approaches for comparing data from different countries or regions. 

FDA has a long history of taking steps to limit data misinterpretation risks. 

Biomass adjustments actually reduce the risk of inappropriate country-to-country comparisons.

Issue 4: Finalizing and using the biomass adjustment method will place undue scrutiny on antibiotic use in livestock

Resolution: Considerably more data is already available on antibiotic use in human medicine than in animal agriculture.

PEW points out that hospitals are required to report hospital-acquired infections to the National Healthcare Safety Network (NHSN), and approximately 800 hospitals nationwide also voluntarily report antibiotic use, based on pharmacy data, to NHSN.

PEW concludes that while biomass-adjusted sales data have limitations, stakeholders will benefit from an improved understanding of antibiotic use.

Read the full report from the PEW Charitable Trusts.

For more on monitoring antibiotic use and resistance trends, see these articles on BovineVetOnline:

Following is the letter Texas A&M System Chancellor John Sharp sent to Harvard President Lawrence S. Bacow.----------------------------------------Dr. Lawrence S. BacowPresidentHarvard UniversityMassa

The United States Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) is announcing the progress the agency is making to implement programs funded by the 2018 Farm

A new program administered by the National Institute of Antimicrobial Resistance Research and Education (NIAMRRE), will soon give producers a better way to demonstrate to consumers that they follow re

The U.S. Food and Drug Administration continues to work with stakeholders to address antiparasitic resistance in livestock (cattle, sheep, goats, swine, and poultry) and horses. In an on-going effort

In a move to address the dramatic global demand for safe, high-quality protein-based food sources, Colorado State University has announced the creation of a first-of-its-kind collaborative to support

The Texas Higher Education Coordinating Board (THECB) on Wednesday (Dec. 11) adopted the recommendation of the Committee on Academic and Workforce Success (CAWS) to approve the request from Texas Tech

FDA’s annual summary report on antimicrobial sales for use in food animals shows a small year-over-year increase in 2018, but the total remains well below pre-VFD levels. According to the report’s

After nearly two years of planning, development and implementation of a cattle disease traceability infrastructure, CattleTrace is inviting all beef industry stakeholders to attend the first-ever Catt

Use of antibiotics is under heightened scrutiny due to the increased prevalence of antibiotic-resistant pathogens. While the primary focus is on more stringent use of antibiotics in medical settings,

On Monday, September 23, the FDA released draft guidance for industry (GFI) #263, outlining a process for voluntarily bringing remaining approved animal drugs containing antimicrobials of human medica

The FDA’s Center for Veterinary Medicine this week issued a final rule, “New Animal Drugs; Updating Tolerances for Residues of New Animal Drugs in Food.” The final rule standardizes and clarifie

The U.S. Food and Drug Administration has approved Monovet 90, manufactured by Huvepharma EOOD, the first generic monensin for use in cattle and goats.In its approval notice, the FDA notes that Monens

Dale Grotelueschen, DVM, MS, retires this week, following a distinguished career serving the beef cattle industry. Since 2003, Grotelueschen has served as director of the University of Nebraska’s Gr

The PEW Charitable Trusts, long involved in public health and antibiotics policy, encourages the FDA to follow through with its plans to adopt a “biomass method” for measuring and analyzing antibi

Poultry’s status as a presumed “healthier” meat could be coming to an end. People have long assumed that poultry, with lower levels of saturated fatty acids compared with most red meats, would c

In recent months, APHIS has revised the Animal Disease Traceability program standards for approving new tags entering the market, with the following goals:Assure that quality devices are approved. Es

The following commentary does not necessarily reflect the views of AgWeb or Farm Journal. The opinions expressed below are the author's own.This week, the Council for Agricultural Science and Technolo

The USDA's Animal and Plant Health Inspection Service (APHIS) is announcing the availability of $1 million in cooperative agreement funding to support animal disease traceability (ADT) and electronic

The JBS Global Food Innovation Center In Honor of Gary & Kay Smith officially opened on the Colorado State University campus Tuesday, April 9, when JBS USA CEO Andre Nogueira cut the ribbon on the $20

USDA Farm Service Agency (FSA) State Executive Director Nancy Johner this week announced that emergency grazing of Conservation Reserve Program (CRP) acres is authorized for all Nebraska counties, due