FDA Releases New Installment of Intentional Adulteration Draft Guidance

Mar 28, 2019 | Michelle Shapiro

The U.S. Food and Drug Administration (FDA) published the second installment of a draft guidance document designed to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA).

The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. Food facilities covered by the rule will be required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. The first compliance date for large facilities arrives in July 2019.

This installment adds to and incorporates elements of the previously published guidance with chapters covering topics such as:

  • the components of the food defense plan;
  • how to conduct vulnerability assessments by
  • using the four Key Activity Types method (bulk liquid receiving and loading, liquid storage and handling, secondary ingredient handling, mixing and similar activities),
  • evaluating the Three Fundamental Elements (potential public health impact, degree of physical access to the product, ability of an attacker to successfully contaminate the product), or
  • using the Hybrid Approach, which is a combination of the Key Activity Types and Three Fundamental Elements methods;
  • how to identify and implement mitigation strategies;
  • food defense monitoring requirements;
  • education, training, and experience.

This installment also includes the addition of food defense plan worksheets in Appendix 1 and a new appendix that includes detailed examples of vulnerability assessments using the Three Fundamental Elements and the Hybrid Approach.

Most of the content from the first installment, published in June 2018, has not been changed in the second installment. We have indicated new content, mostly located in Chapter Two, Chapter Eight, Appendix 1 and Appendix 4, with brackets stating, “[New March 2019] or [Updated March 2019].”

This draft guidance, in its entirety, is intended to be a resource that will help the food industry implement the IA provisions in a flexible and cost-effective manner. During the 120-day comment period for this installment, stakeholders will also be able to provide comments on the first and second installments of the draft guidance. A public meeting on the draft guidance is being planned and additional information will be made available in a forthcoming announcement.

For More Information


636530147572900000

About Michelle Shapiro

Michelle Shapiro is a communication specialist for the Environmental Health & Disability team at NACCHO.

More posts by Michelle Shapiro

0 Comments

Related Posts

2000px US CDC logo
  • COVID-19
  • Tools & Resources
  • Emergency Response

COVID-19 Disaster Shelter Interim Guidance

The CDC has released interim guidance to reduce the risk of introducing and...

Jul 13, 2020 | Beth Hess

COVID-19 Disaster Shelter Interim Guidance

  • National Environmental Public Health Tracking

Linking Exposures and Health Effects to Environmental...

This year, NACCHO piloted a technical assistance program focused on...

Jul 10, 2020 | Tiara Smith

Linking Exposures and Health Effects to Environmental...

2019 Profile Workforce and Finance Capacity final May 2020 Page 1
  • Press Release

NACCHO New Analysis: Changes in Local Health Department...

— Updated data highlight pre-COVID challenges and potential impact of...

Jul 10, 2020 | Andrea Grenadier

NACCHO New Analysis: Changes in Local Health Department...

Cdc badge small
  • Tools & Resources

CDC Report: Temporary Reassignment of Personnel Requests...

CDC recently updated its flexibilities guidance for recipients and applicants...

Jul 09, 2020 | Kim Rodgers

CDC Report: Temporary Reassignment of Personnel Requests...

Jennifer kertanis headshot 24152456360
  • Opportunity

Top Moments From Day Two at NACCHO 360

Welcome to the final day of NACCHO 360! Yesterday NACCHO Chief Executive...

Jul 09, 2020 | Taylarr Lopez

Top Moments From Day Two at NACCHO 360

COVID VC Screenshot
  • COVID-19
  • Tools & Resources
  • Emergency Response
  • Infectious Disease

NACCHO’s COVID-19 Virtual Community Now Available to All...

NACCHO has opened our COVID-19 Virtual Community to all local health department...

Jul 08, 2020 | Kim Rodgers

NACCHO’s COVID-19 Virtual Community Now Available to All...

Sync2020 logos horizontal 1024x304
  • HIV, STI, & Viral Hepatitis

Scholarships Available: SYNChronicity 2020 Conference –...

SYNC 2020, the National Conference for HIV, HCV, STI and LGBTQ Health, is...

Jul 08, 2020 | Julia Zigman

Scholarships Available: SYNChronicity 2020 Conference –...

  • COVID-19
  • HIV, STI, & Viral Hepatitis
  • Research & Reports

Kaiser Family Foundation: Reduction in Sexual and...

The Kaiser Family Foundation released a new issue brief, Potential Impacts of...

Jul 08, 2020 | Julia Zigman

Kaiser Family Foundation: Reduction in Sexual and...

2000px US CDC logo
  • HIV, STI, & Viral Hepatitis

New Recommendations for Hepatitis Vaccination

CDC has released new recommendations for hepatitis A virus (HAV) vaccination,...

Jul 08, 2020 | Julia Zigman

New Recommendations for Hepatitis Vaccination

Back to Top