IRAC Member Agencies
Most of the IRAC member agencies have similar reasons for participating in the IRAC, such as enhanced communication between agencies and the desire to learn from others. The following short descriptions focus on the more unique reasons each agency is involved in the IRAC.
Department of Health and
Human Services/ Centers for Disease Control and Prevention (DHHS/CDC)
National Center for Infectious
Diseases/ Division of Bacterial and Mycotic Diseases/ Foodborne and Diarrheal
Disease Branch (NCID/DBMD)
CDC participates in the IRAC because it is a major source of data used to support government risk assessments. CDC's research and surveillance programs provide exposure and human health outcome data for food safety risk assessments. Risk communication is an important aspect of CDC's mission and involvement in IRAC activities gives CDC systematic opportunities for interacting with multiple agencies and the public through the IRAC annual public meetings. CDC surveillance programs provides risk managers and risk assessors with a mechanism for observing the effectiveness of policy changes.
Department of Defense/ U.S Army Veterinary Service Activity (DOD/VSA)
DODVSA is responsible for the food safety of the military's food supply. The broad distribution of US military personnel throughout the world requires that DODVSA design it's own inspection programs to certify food vendors all over the globe. DODVSA participates in the IRAC to stay abreast of new developments that impact domestic regulatory actions. DODVSA also has a long history of food sampling programs that may generate data with a broader utility than just military needs. As risk managers, DODVSA finds the IRAC to be an important way to communicate with food safety risk assessors.
Environmental Protection Agency/ Office of Prevention, Pesticides and Toxic Substances (EPA/OPPTS)
OPPTS has broad mandates to protect public health and the environment from potential risk from toxic chemicals for now and for generations to come. Included in these mandates is the establishment of maximum levels for pesticide residues and other toxic substances in food. Risk assessment has always been a primary statutory activity for OPPTS since EPA was formed. Currently OPPTS is developing risk assessment methodologies for assessing aggregate and cumulative risks and setting acceptance criteria for those methodologies. OPPTS works closely with EPA's ORD to determine research needs and develop research strategies to meet those needs. In addition, OPPTS has developed a peer review process for evaluating risk assessment paradigms. Risk assessments are used by the agency for the development of new standards. Standards set by OPPTS are required by law to address the needs of identifiable subpopulations, such as children and pregnant women as well as the population as a whole. OPPTS' participation in the IRAC allows them to be involved in the process of food safety risk assessment methodology development within several government agencies.
Environmental Protection Agency/ Office of Research and Development (EPA/ORD)
ORD is the principal scientific and research arm of the Environmental Protection Agency. ORD's research program is organized around the risk assessment/risk management paradigm. The paradigm is a sequenced set of specific interrelated analytic steps that are employed in assessing environmental risks and making decisions on how to reduce those risks. Simply stated, these steps involve a process to: 1) characterize the nature and magnitude of human health or environmental effects; 2) determine the magnitude and routes of exposure to causative contaminants or stressors; 3) combine these into an assessment of risk; and, 4) evaluate sources and implement strategies or technologies to reduce risk. The research conducted by ORD fosters the use of science and technology in fulfilling EPA's mission of protecting human health and safeguarding the natural environment.
Additionally, ORD promotes Agency-wide consensus on difficult and controversial risk assessment issues and ensures that this consensus is incorporated into appropriate Agency risk assessment guidance. Clean/safe water and safe food are two of ORD's major research issues and using the collaborative efforts of the IRAC, we collectively work to enhance communication and coordination among the member agencies and promote the conduct of scientific research that will facilitate risk assessments. Such collaboration assists the EPA in fulfilling our specific food-safety risk management mandates.
Environmental Protection Agency/ Office of Water (EPA/OW)
The EPA's Office of Water is required to utilize risk based approaches for new and revised water regulations. The Office of Water also uses a risk based approach for helping to identify and prioritize research needs to meet programmatic and regulatory requirements. Because the Office of Water writes regulations, determines research needs, conducts studies to support regulation development, and performs risk assessments, it is involved in all aspects of risk analysis from data collection to risk management decisions. In addition to the safety of drinking, recreational and ambient waters, EPA's activities are also collaterally related to food safety because water is used in food irrigation, washing, reconstitution of food products, and in maintaining livestock animal health. The Office of Water participates in the IRAC to both assist other governmental agencies with their risk assessment needs and to consult with the other members to gain risk assessment insights from their areas of expertise. The Office of Water is currently utilizing IRAC expertise for assistance in developing formal EPA guidelines for microbiological risk assessments in water media.
Department of Health and Human Services/ Food and Drug Administration/ Center for Food Safety and Applied Nutrition (DHHS/FDA/CFSAN)
CFSAN protects public health by regulating a wide range of domestic and imported foods. Risk assessments are used to assist making regulatory decisions and to identify research needed to improve regulatory programs. CFSAN collaborates with many of the IRAC member agencies in research and risk assessments. The IRAC provides a mechanism for interactions between CFSAN risk assessors and the other agencies to further develop risk assessment methodology and has been a useful forum for sharing information about CFSAN risk assessments and learning about risk assessments from other agencies. CFSAN plays an important role in the IRAC workgroup that advises the JIFSAN Food Safety Risk Analysis Clearinghouse. CFSAN has found that IRAC-sponsored public meetings and workshops have been useful for helping further overall CFSAN goals to build our capacity to conduct microbial risk assessments. CFSAN co-chairs the IRAC policy council with USDA's FSIS.
Department of Health and Human Services/ Food and Drug Administration/ Center for Veterinary Medicine (DHHS/FDA/CVM)
CVM is responsible for ensuring that products used in animals are both safe and effective for animals and safe for humans. Chemical residues in the meat supply and the effects of anti-microbials on farm microbial flora and in the larger environment are two areas of active risk assessment for the Office of New Animal Drug Evaluation at CVM. The particular effect of anti-microbial use on farm that is the subject of microbial risk assessments at CVM is increased prevalence of drug resistant bacteria to which humans are ultimately exposed. CVM maintains research laboratories and funds research projects that generate data that may be used in risk assessments. CVM has utilized IRAC expertise to assist in the planning of risk assessments and searching for data sources.
Department of Health and Human Services/ Food and Drug Administration/ National Center for Toxicological Research (DHHS/FDA/NCTR)
NCTR is a research facility in Arkansas that runs studies and generates data that are requested by the FDA centers for use in risk assessment and other purposes. NCTR has many research projects and some involve biologically based dose-response modeling. In some cases NCTR researchers present data specifically with risk assessment in mind. Researchers at NCTR publish results from studies and methodology development, such as risk assessment methods and statistical methods, in peer reviewed journals. NCTR is involved in the IRAC to keep in contact with food safety risk assessors throughout the federal government and to be involved in work group activities that develop risk assessment methods.
Department of Health and Human Services/ Food and Drug Administration/ Office of Women's Health (DHHS/FDA/OWH)
The FDA Office of Women's Health ensures that all of the Agency's regulatory activities remain gender sensitive. Considering gender differences in FDA's risk assessments is critical because men and women differ in their exposure and response to food contaminants. Furthermore, a woman's exposure and response to food contamination can change with changes in physiological status such as pregnancy and menopause. Thus, gender differences affect risk analysis from the earliest stages of risk assessment, in exposure assessment and risk characterization through later phases of risk management in the development of gender-based strategies to communicate risk. The expertise provided by the OWH assists the IRAC in improving the characterization of risk to the population by utilizing a gender based approach.
Department of Health and Human Services/ National Institutes of Health/ National Institute of Allergy and Infectious Diseases (DHHS/NIH/NIAID)
NIH supports basic and clinical research on the detection, pathogenesis, treatment, and prevention of diseases caused by organisms that can be transmitted in food and water. Although NIH is not directly involved in risk assessment activities, the NIH IRAC representative serves a contact point for expertise on various pathogens. NIH participation in the IRAC also facilitates possible interagency collaboration, and serves as a research resource by providing a link to NIH grantees that conduct studies of interest to risk assessors. Of particular interest is NIH supported research on dose-response studies in animals or humans as part of clinical trials to test vaccine protective efficacy.
Department of Commerce/ National Oceanic & Atmospheric Administration/ National Marine Fisheries Service (DOC/NOAA/NMFS)
The U.S. Department of Commerce operates a voluntary Seafood Inspection Program which is actively involved in seafood safety issues including, product and processing facility inspections, laboratory analyses, risk assessments, risk management, and risk communication as well as product quality determinations. Participation in the IRAC fosters communication with other federal agencies engaged in risk assessment activities. The National Marine Fisheries Service is interested in utilizing risk assessment tools and techniques as they relate to risk management and communication seafood consumption issues, as well as to fisheries management issues and other agency activities.
United States Department of Agriculture/ Animal & Plant Health Inspection Service (USDA/APHIS)
The Animal and Plant Health inspection Service (APHIS) is responsible for protecting and promoting U.S. agricultural health, administering the Animal Welfare Act, and carrying out wildlife damage management activities. The APHIS mission is an integral part of U.S. Department of Agriculture's (USDA) efforts to provide the Nation with safe and affordable food.
APHIS protects America's animal and plant resources from agricultural pests and diseases, thus thwarting threats to our food supply and to our Nation's economy. APHIS assesses and regulates the risks associated with agricultural imports, as well as negotiates science-based standards that ensure America's agricultural exports are protected from unjustified trade restrictions. APHIS manages wildlife damage, and protects the welfare of animals in laboratories and zoos. APHIS also protects human health and safety, and ecosystems vulnerable to invasive pests and pathogens.
APHIS continuously strives to improve its risk assessment methods so it can more efficiently and effectively achieve its mission. The IRAC provides a platform where agencies can share risk assessment methodologies, data, research, regulations, policies, processes, strategies and vision. The IRAC also provides an opportunity to discuss risk issues of concern to multiple agencies in areas such as food safety, agricultural health, human health and environmental protection. Examples of specific issues that raise multiple agency interest include the control/management of zoonotic diseases like highly pathogenic avian influenza, the feeding of animal-origin feeds to ruminants, and the use of methyl bromide for fumigating imported agricultural products.
APHIS looks forward to contributing to, and learning from, the IRAC experience.
United States Department of Agriculture/ Agricultural Research Service (USDA/ARS)
The Agricultural Research Service (ARS) is the principal research agency of the U.S. Department of Agriculture (USDA). ARS, one of the Research, Education and Economics (REE) agencies, is charged with extending the Nation's scientific knowledge across a broad range of program areas that affect the American people on a daily basis. ARS has a long history of interaction with two Federal Agencies with regulatory and action authority, to specifically assist their food safety research needs, including research for risk assessments. These agencies are the USDA - Food Safety Inspection Service (FSIS) and the FDA - Center Food Safety and Nutrition (CFSAN).
ARS does not perform risk assessments within the food safety research program, however, we provide data for other agencies to use in developing risk assessments. Specifically, ARS has collaborated in research for the Salmonella enteritidis, Escherichia coli O157:H7 and Listeria monocytogenes risk assessments. The Pathogen Modeling Program (PMP) was initially developed by ARS and continues to be improved by ARS collaborating with other scientists in the U.S., Canada and the United Kingdom. Pathogen growth modeling under various stresses is an important element in many risk assessments for foodborne disease.
ARS participation in the IRAC helps the agency stay in touch with developments in risk assessment, including methodology development, and data generation and collection. Participation also allows ARS to present the researcher's point of view to risk assessors and regulators within the IRAC.
United States Department of Agriculture/ Cooperative State Research, Education, & Extension Service (USDA/CSREES)
CSREES is the primary extramural research funding agency in USDA. They provide competitively-funded grants to universities, government agencies, professional organizations and industry groups on a variety of topics including food safety- related research, projects for the development of risk assessment methodology, and risk assessments. CSREES funds research that seeks to provide data for identified research gaps in ongoing and planned government (and other sponsored) food safety risk assessments. The CSREES program under the National Research Initiative, Epidemiological Approaches for Food Safety, provides competitive grants for applied on-farm research. CSREES keeps the other IRAC representatives informed about funding opportunities that may interest the IRAC member agencies. They have also facilitated interactions between IRAC member agencies and CSREES grant recipients at universities. CSREES' participation in the IRAC helps provide its members with current research and educational efforts occurring in the university system and allows CSREES the opportunity to communicate the latest developments in food safety risk assessments to the land-grant system.
United States Department of Agriculture/ Economic Research Service (USDA/ERS)
ERS is interested in risk assessment because it is a critical input for benefit-cost analyses. Risk assessments can be used to model alternative pathogen control options and help define the benefits of public and private pathogen reduction efforts. ERS examines the marketplace (public, private, government) impacts and describes costs and benefits of different scenarios to all sectors. ERS also analyzes the economic incentives for private innovation to further USDA's safe food supply goals. As an end user of risk assessments, ERS participates in the IRAC on projects that develop risk assessment tools, so that risk assessments are more useful for economists and are better integrated with economic analysis.
United States Department of Agriculture/ Food Safety Inspection Service (USDA/FSIS)
FSIS protects the public health by regulating meat, poultry, and egg products. Because FSIS considers risk assessment to be an important component of the regulation process, the agency has embarked on several major microbiological risk assessment projects (BSE, E coli O157 H7, S. enteritidis and L. monocytogenes). FSIS is a leader in microbiological risk assessment methodology and considers the IRAC to be an important forum for being involved in state of the art risk assessment methodology development. FSIS co-chairs the IRAC policy council with FDA's CFSAN.
United States Department of Agriculture/ Office of the Chief Economist/ Office of Risk Assessment and Cost Benefit Analysis (USDA/OCE/ORACBA)
The Office of Risk Assessment and Cost-Benefit Analysis (ORACBA) participates in the IRAC because of our interest in improving the methods and quality of risk assessments. Good regulations should be based on risk assessments. ORACBA reviews all major (>$100 million impact) USDA regulations affecting human health, safety, or the environment along with their accompanying risk assessments to assure adequacy. ORACBA provides training and guidance on conducting risk assessments and also helps coordinate risk assessments within USDA. In addition, ORACBA participates in IRAC in order to keep current with activities and developments at other Federal agencies as well as sharing new information and lessons learned.
Last Updated: February 10, 2004
