Category Archives: Uncategorized

AFDO Journeys Toward the Integrated Food Safety System Vision

As an AFDO industry member, Remco Products Corporation is proud to have participated in the 121st Association of Food and Drug Officials Conference this June. Over 400 members from federal, state, and local agencies, as well as members of industry groups, trade associations, consumer organizations, and academia, made the trip to Houston for the recent conference.

AFDO has, over time, become a recognized voice in promoting uniform, simplified, and efficient laws, regulations and guidelines related to food safety and public health. Their humble beginning predates the existence of the FDA by 10 years when in 1896, two state commissioners from Michigan and Ohio met in Toledo to discuss the difficulties of manufacturing food in one state and shipping it to another, where the same product may not have complied with the local statutory regulations.

The push for states to collaborate and come to a mutually acceptable solution eventually resulted in a streamlined regulatory solution across the states. With time, AFDO became a forerunner in publishing model codes and guidance for various foods, which have been used to formulate aligned state regulations. The defining moment arrived in 1998, when AFDO was the first to offer a vision of a national Integrated Food Safety System (IFSS) that would empower state and local authorities to collaborate effectively with their federal counterparts. The crowning glory came with the passage of FSMA in 2011, which shifted the FDA’s focus from the reactive to the preventive mode of addressing food safety risks, which also mandated the adoption of IFSS across the food supply network.

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How is HARPC Different From HACCP?

HACCP and HARPC share more than just four letters. They’re both food safety standards based on prevention, but they do differ on execution. Their differences and their similarities aren’t as important as the way they fit together for most food processors, though. A HARPC plan shouldn’t be considered as a replacement, but as a necessary upgrade to the conventional HACCP plan. Understanding how the systems fit together is the first step toward implementing both.

HACCP

HARPC

(1) Is the preventative approach based on a standard, guideline or a set of laws?
Based on a guideline recommended by CODEX and NACMCF Based on FSMA act and principally, the Final Rule for Preventive Controls for Human Food
(2) What food safety risks are considered using the preventative approach?
Conventional – Biological, Chemical, and Physical Beyond the conventional risks for actual and potential food safety hazards
(3) What is the goal of the preventative approach?
To prevent, eliminate (or) reduce hazards to a safe level (in that priority) Preventive controls that prevent or significantly minimize “known or reasonably foreseeable” risks
(4) Who is primarily responsible for the development and maintenance of the preventive plan?
Primarily, a competent HACCP coordinator with assistance from multidisciplinary team Trained Preventive Controls Qualified Individual (PCQI) as described in the FSMA Act
(5) At what frequency is the preventive plan being reviewed by the facility?
At least once a year, or when required At least once in 3 years, or when required
(6) The plan is mandatory for what type of establishments?
For FDA and USDA mandated establishments, or when required for certification purposes For all establishments along the food supply chain that serve U.S. consumers, unless exempted
(7) The plan is excluded or exempted for what type of establishments?
Unless mandated or required for certification, HACCP is voluntary, and GMPs are mandatory Exemption list is provided by FDA, but this does not exempt facilities from following at least CGMPs
(8) Who is the interested party here? For whom is the plan for?
Stakeholders: auditors, inspectors, and customers The FDA
(9) What is the documented approach for making the preventive plan?
12 Steps of HACCP (includes 7 Principles) 7 Steps of Developing a HARPC Plan

HARPC as an Upgrade to HACCP

HACCP, or Hazard Analysis Critical Control Points, is already widely used due to requirements from retailers, auditing standards, and inspectors, though the USDA and the FDA only mandate it for meat, seafood, and juice products. As a global standard conceptualized the 1960s, HACCP has been continually developed and updated. HACCP requires a multi-disciplinary team for implementation and follows prescriptive steps.

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FDA Final Rule on the Sanitary Transportation of Food Compliance Gains Momentum

 

The FDA’s final rule on the sanitary transportation of food went into effect June 6, 2016. Though larger carriers, shippers, and receivers should have their compliance plans in place, smaller companies (fewer than 500 employees and less than $27.5 million in annual receipts) still have two years from the rule publication date to comply with the requirements.

This final rule—the sixth of seven rulemakings for FSMA—was based on a combination of the Sanitary Transportation of Food Act of 2005 and about 240 submissions from transportation companies, food safety organizations, consumer advocacy groups, and more.

The rulemaking has been proposed to ensure:

  1. Proper refrigeration during transportation of foods that require it;
  2. That vehicles and food storage are adequately cleaned and sanitized; and
  3. That there is adequate protection for food during transport.

Waivers have been proposed to exempt carriers, shippers, and receivers who hold valid permits and are inspected under National Conference on Interstate Milk Shipments (NCIMS) Grade ‘‘A’’ Milk Safety Program only when they’re shipping Grade A milk and milk products. The exemption should also apply to retail and food service operations that hold valid permits only when they are engaged in transportation operations as receivers, or as shippers and carriers in operations in which food is relinquished to consumers after transportation from the establishment.

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FDA Inspection Checklist

Remco Products presents Food Industry Counsel’s FDA Inspection Checklist as a part of our commitment to bringing our audience the best information in the food industry. We don’t endorse any legal services or provide legal advice. For legal services or advice, please consult your attorney.  You can also contact Shawn Stevens, the author of this post, at stevens@foodindustrycounsel.com.

What to do Before, During and After Your Next FDA Inspection

Food Industry Counsel, LLC is pleased to provide you with the most comprehensive and useful FDA Inspection Checklist available. With the passage of the Food Safety Modernization Act (FSMA), the Food and Drug Administration (FDA) was given the mission of overhauling the safety of the nation’s food supply. The new FSMA regulations written by FDA are now coming into effect, and the agency is now aggressively enforcing its new rules during routine inspections. Within the coming years, FDA Investigators will conduct an onsite inspection of every food facility in the U.S.

Here are FDA’s new enforcement priorities during routine unannounced inspections:

(1) To carefully critique each company’s written food safety programs and verification records to ensure they are compliant with the new FSMA requirements;

(2) To conduct extensive Zone 1, Zone 2, Zone 3 and Zone 4 microbiological sampling inside all food facilities to find evidence of pathogenic contamination;

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How to Prepare a New Cleaning Tool for Use

New cleaning tools—especially those sealed in plastic pouches like the ones from Vikan and Remco—often look like they’re ready for use right out of the bag. It’s easy to assume these tools can start sweeping, mopping, and brushing right away, however, as most in the food industry know, looking clean isn’t the same as actually being clean. Here are a few steps that must be taken to ensure all new tools are ready for use in food production plants:
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