Tag: FSMA

Accredited Third Party Certification Program

Accredited Third Party Certification Program was established under FDA’s FSMA (Food Safety Modernization Act). It is a voluntary program in which FDA recognizes accreditation bodies that will have the responsibility of accrediting third party certification bodies. Such certification bodies will conduct food safety audits and issue certifications to foreign food facilities. A certification body will conduct two kinds of audits: Consultative and Regulatory. A consultative audit will help foreign facilities prepare for a regulatory audit. If a regulatory audit determines that the facility is in compliance with US food safety requirements, the facility is awarded with a certification.

A certification body is required to report to FDA results of both types of audits immediately if serious risk to public health is predicted.

The certifications obtained through FDA’s Accredited Third-Party Program serves two purposes:

  • Importers can use a certification to establish eligibility to participate in Voluntary Qualified Importer Program (VQIP)
  • FDA can require certification as a condition of entry for specific imported food products.

An accreditation body has the followed duties under the Accredited Third-Party Certification Program:

  • Assess third party certification bodies competence if they can be accredited.
  • Monitor the performance of certification bodies it accredits and notify FDA of any change in their status.
  • Submit all data regarding certification bodies and its own performance to FDA

A certification body has the following duties:

  • Ensuring audit agents competence
  • Verify a facilities food safety plans effectiveness
  • Submit all data required by the program and report of its own performance to FDA.

Foreign governments, agencies or private third parties may apply to become accreditation bodies as well as certification bodies.

Requirements to become an Accreditation or Certification body:

  • Authority to assess third party for accreditation or conduct site audits and review records
  • Competency to have adequate finances, skills, resources and experience for operation.
  • A written quality assurance plan
  • Written measures to protect against conflicts of interest
  • Written procedures to establish, control and retain records.

FDA will post a notification on its webpage every time it recognizes an accreditation body and also when a certification body is accredited.

In March 2019, FDA’s accreditation body ANSI has accredited two third party certification bodies: SGS North America Inc of Rutherford, NJ and NSF Certification, LLC of Ann Arbor.

Liberty Management Group LTD  is one of the leading FDA consulting group in the USA. LMG provides assistance with Registrations, Label compliance, and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on April 10, 2019

FSMA – PRODUCE SAFETY RULE

As per FDA about 48 million people get sick, 128000 are hospitalized and 3000 die every year from food borne illnesses. FSMA (Food Safety Modernization Act) was signed into law in 2011 by President Obama to reform America’s food safety system. It enables FDA to focus on preventing food problems rather than reacting to problems after they have already occurred.

To implement FSMA, FDA has finalized seven major rules which recognize that ensuring food safety is a shared responsibility among various points in the global supply chain for both human and animal food. One of the rules that takes care of farms is Produce Safety Rule, officially known as Standards for the Growing, Harvesting, Packing and Holding of Produce for Human Consumption.

Produce Safety Rule established science-based standards for safe growing, harvesting, packing and holding of fruits and vegetables grown for human consumption. The rule lays down preventative measures that would help bring significant benefits to consumers. The measures take care of:

  • Agricultural water
  • Farm workers training on health and hygiene
  • Biological soil amendments
  • Domesticated and wild animals’ control
  • Equipment, tools and building
  • Sprouts

Food safety risk is high for certain foods example leafy vegetables. In November 2018, several warnings were issued to consumers to avoid eating lettuce in US, as there was an E. coli outbreak linked to it, while there were investigations ongoing.

FDA has provided various compliance dates depending on the size of producer and type of produce.

FDA will begin routine inspections of large farms, other than sprouts operations, in spring 2019. The routine inspection of small farms will begin in spring 2020.

Farmers may refer to the draft guidance created by FDA to know how these requirements can be met.

Liberty Management Group LTD  is one of the leading FDA consulting group in the USA. LMG provides assistance with various FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on February 20, 2019