FDA Issues Draft Guidance for Reducing Food Safety Hazards in the Production of Seed for Sprouting

Jul 01, 2019 | Michelle Shapiro

On June 24, 2019, the U.S. Food and Drug Administration issued draft guidance to provide recommendations to those in the sprout seed industry to help reduce food safety hazards in the production of seed used for sprouting.

Between January 1996 and August 2018, contaminated sprouts were associated with 50 outbreaks, which together resulted in more than 2,600 cases of foodborne illness. Studies indicate that contaminated seed is the likely source of most sprout-related outbreaks.

Sprouts represent a special food safety concern because the conditions under which sprouts are produced (time, temperature, water activity, pH and available nutrients) are also ideal for the growth of pathogens, if present. Because the distinctive practices and conditions for growing sprouts present unique risks, the Produce Safety Rule, as required by the FDA Food Safety Modernization Act (FSMA), includes sprout-specific requirements. However, we consider the seeds used for sprouting to be outside the definition of “covered produce” under the rule, and activities such as growing, conditioning, and distributing seeds to be outside the scope of “covered activities” in the rule. Therefore, we did not prescribe specific requirements in the Produce Safety rule to prevent the introduction of known or reasonably foreseeable hazards into or onto seed during growing, harvesting, conditioning, or holding of seed.

In addition, although that the end use of seed may sometimes be unknown by the farmers who grow the seed and by the conditioners and distributors who handle the seed, seed for sprouting is considered “food” under the Federal Food, Drug, and Cosmetic Act. Therefore, the draft guidance released today is intended to provide food safety recommendations for those that grow, condition, pack, hold or distribute seed for sprouting.

In this draft guidance, the FDA recommends that seed for sprout production be grown using good agricultural practices (GAPs) or in conformance with international standards such as the Codex Alimentarius International Code of Hygienic Practice for Fresh Fruits and Vegetables, and that seed is packed and held under sanitary conditions. The draft guidance released today also recommends that all firms in the sprout seed supply chain take steps to reduce microbial food safety hazards in seed for sprouting, including training personnel who have food safety responsibilities, storing seed for sprouting separately from seed for other uses, and ensuring that food contact surfaces are cleanable and cleaned regularly.

In the development of the draft guidance, we considered three documents related to food safety and hygienic production of seed for sprouting: the Codex Code of Hygienic Practice for Fresh Fruits and Vegetables Annex II, Annex for Sprout Production; the International Sprout Growers Association-Institute for Food Safety and Health’s “U.S. Sprout Production Best Practices”; and the European Sprouted Seeds Association Hygiene Guideline for the Production of Sprouts and Seeds for Sprouting. We have incorporated aspects of these documents in this draft guidance.

The draft guidance will be available for public comment for 60 days starting June 25, 2019. Although comments can be submitted at any time, we recommend that you submit comments on or before August 26, 2019 to ensure that we consider your feedback during the development of the final version of this guidance. Comments can be submitted electronically at https://www/regulations.gov. Comments can also be mailed to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2018-D-4534 listed in the notice of availability that publishes in the Federal Register.

Additional 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

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

TAG Logo
  • HIV, STI, & Viral Hepatitis
  • Research & Reports

Treatment Action Group 2020 Pipeline Report Now Available

Treatment Action Group (TAG) recently published their 2020 Pipeline Report, an...

Jul 08, 2020 | Julia Zigman

Treatment Action Group 2020 Pipeline Report Now Available

Pr EP injectable
  • HIV, STI, & Viral Hepatitis
  • Research & Reports

New Study: Injectable PrEP is Safe and Highly Effective

New data further shows an injectable antiretroviral for HIV pre-exposure...

Jul 08, 2020 | Julia Zigman

New Study: Injectable PrEP is Safe and Highly Effective

MMWR
  • HIV, STI, & Viral Hepatitis
  • Research & Reports

HIV Testing Trends at Visits to Physician Offices,...

A recent report from CDC shows low rates of HIV testing in physician offices,...

Jul 08, 2020 | Julia Zigman

HIV Testing Trends at Visits to Physician Offices,...

Back to Top