Analysis Programs, Specifications, Compliance

Food Safety Modernization Act action steps

Part I: Food Gas Hazard Analysis Programs
There are two different food gas hazard analysis programs (HAACP and HARPC). These programs can seem difficult to implement, but the GAWDA Food Gas Program handles the requirements.

The Old Program – Hazard Analysis and Critical Control Points (HAACP)

HAACP is a written management system in which food safety is addressed through the analysis and control of biological, chemical and physical hazards from raw material production, procurement and handling to manufacturing, distribution and consumption of the finished product. HAACP contains seven elements or principles:

  1. Conduct a hazard analysis.
  2. Determine the process critical control points (CCPs).
  3. Establish the process critical limits.
  4. Implement monitoring procedures.
  5. Implement corrective action programs.
  6. Implement verification and validation programs.
  7. Implement record keeping and documentation programs.

FDA is enforcing HAACP for certain high-risk food industries: dairy, juice, seafood and food service. Some food gas companies have completed voluntary HAACPs. Our recommendation is to only complete the HAACP process if your customer or FDA requires you to do so. Contact your GAWDA FDA Consultant if you are being required to complete a HAACP.

The New Program – Hazard Analysis and Risk Prevention Controls (HARPC)

HARPC is the replacement to HAACP and we expect it to eventually become mandatory.

HARPC is required under section 103 of the Food Safety Modernization Act (FSMA), and takes the HACCP model further with preventative controls and risk mitigation using these elements:

  • Hazard Analysis
  • Monitoring of Preventive Control Effectiveness
  • Process Controls, Allergens, Recalls, Sanitation Controls
  • Verification and monitoring documentation
  • Food Safety Plan
  • Continuous Analysis of the Food Safety Plan (three year max)
  • Qualified Individual

FDA has not published final implementation guidance for HARPC yet. Nevertheless, GAWDA and CGA are developing HARPC templates to make the anticipated HARPC process easier. The HARPC for Air Separation Units is being developed first, followed by the HARPC for cylinder plants.

After FDA issues final implementation guidance, we expect the implementation schedule to be easily achievable:

  • Small Businesses (<500 employees): two years after final publication of the regulation
  • Very Small Businesses (<$1 million in total annual sales of human food): three years after publication of the final rule to comply.

You will have access to HARPC templates and procedures from GAWDA well before it becomes mandatory by FDA.

Part II: How to Determine Which Food and Beverage Gas Specifications to Use

In a regulatory sense, the food/beverage gas industry is still relatively young, and there still are significant differences between the accepted specifications of the food gases and beverage gases.

In the United States, there are three organizations publishing food and beverage gas specifications:

  • Food Chemical Codex (FCC)
  • Compressed Gas Association (CGA)
  • International Society of Beverage Technologists (ISBT)

The FCC is the standard recognized by FDA as the official specification for food ingredients that are “Generally Recognized As Safe” (GRAS), including food and beverage gases. See 21 CFR 170.30(h)(1). The list of GRAS substances are found in 21 CFR 184 and include: butane/iso-butane, carbon dioxide, helium, nitrogen, nitrous oxide, propane, etc.

FDA’s definition of food gases also includes gases used for beverages. So from an FDA perspective, FCC defines the specifications for food AND beverage gases.

CGA publishes food and beverage gas specifications in the CGA Commodity Specifications:

  • G-6.2-2011 Commodity Specification For Carbon Dioxide, Grades H for food applications and Grade I for beverage applications
  • G-10.1-2008 Commodity Specification For Nitrogen, Grades B, L and M – partial specifications for food processing and blanketing

For carbon dioxide, the CGA specification G-6.2-2001 Grade H is similar to the FCC specification for food/beverage applications, and Grade I is similar to the ISBT beverage gas specifications.

ISBT publishes beverage gas specifications that go far beyond the minimum FCC specifications. For example, the FCC food gas purity specification is 99.5% while the ISBT beverage gas purity specification is 99.9%. ISBT has many other trace contaminant specifications that go beyond the minimum FCC specification (methanol, ammonia, acetaldehyde, etc.)

See chart for a sample comparison of the FCC, CGA and ISBT specifications for carbon dioxide.

Which Gas Specification Should I Use?

There are no universally accepted specifications for food and beverage gases. Until such a specification exists, consider this:

  1. At least comply with the FDA’s expectation (FCC)
  2. If your customer expects a higher specification (CGA Grade I, ISBT, etc.), use that specification.

In either case, be sure your supplier gives you a Certificate of Conformance (or Certificate of Guaranty) for the minimum grade you need. We suggest that you get this certificate on an annual basis. For example, if your customers expect the minimum FCC specification (the default), your supplier can conform to any of typical grades (FCC, CGA G-6.2 Grade H, CGA G-6.2 Grade I, ISBT). However, if your customers expect ISBT carbon dioxide, your supplier should certify that they comply with ISBT. FCC grade would not assure compliance with the higher grade.

Part III: Where to Find Food Compliance Requirements

There have been significant regulatory changes regarding food “Current Good Manufacturing Practices” (CGMP or GMP). It can be difficult to find the exact compliance requirements. For example, here are the major food compliance requirement source documents that FDA enforces:

21 CFR 110 Good Manufacturing Practices–Food: This is the source for food GMPs. The following basic subjects are covered in these regulations: Personnel Requirements, Buildings and Facilities, Equipment, Production/Process Controls, Defect Action Levels, etc. For compliance traceability, the full text of 21 CFR 110 is printed in the GAWDA Food Gas Procedures, free to members.

21 CFR 184 Generally Recognized As Safe Ingredients (GRAS): This section of the regulations designates the common gases (CO2, N2, etc.) as GRAS.

Food Safety Modernization Act (FSMA): FSMA gives the FDA additional authority to conduct investigations and recalls. It also revises and strengthens the basic GMPs. For example, the FSMA is where the two year records retention period is listed. The requirement to trace food lot numbers is also included in the FSMA. These additional requirements are found in the GAWDA Food Gas Procedures.

Bioterrorism Act of 2002

The Bioterrorism Act required that food production and warehousing facilities be registered.

Since 2002, the FSMA revised the registration requirement to occur between October 1 and December 31 in even numbered years.

In addition, CGA–M-10-2012, Food Safety Management Systems and Good Manufacturing Practices for Food Gas Manufacturers, is an excellent summary of food GMP. This publication closely follows the FDA’s regulations with some enhancements for food gas industry interpretations and references. See www.cganet.com to obtain CGA M-10.

The International Society of Beverage Technologists (ISBT) publishes gas specifications for carbon dioxide and nitrogen. In addition to the gas specifications, documents include some process requirements for operating bulk production plants (testing frequencies, tank venting requirements, certification requirements, etc.)

For those companies desiring recognition by international food quality management organizations, consider GFSI – Global Food Safety Initiative, ISO 22000, FSSC 22000, etc. These international recognitions are not required to produce food gases in the United States. Some international food companies prefer their suppliers to comply with these additional standards.

Some large domestic firms have vendor requirements that go beyond the minimum FDA GMPs. These requirements are often called Food Quality Management Systems and include areas not specifically required under FDA regulations, i.e., crisis management programs, complaint procedures, mock recalls, management of change, security, etc. If you have customers requiring these enhanced features in your procedures, contact me. We have GAWDA programs and procedures to assist you in these cases.

Action Steps

  1. Download and adopt the free GAWDA Food Gas SOPs. These will help you comply with FDA food regulations and CGA M-10.
  2. Attend the free monthly GAWDA Food Gas Roundtables. These typically are held on the last Friday of each month at 2:00 PM Eastern Time. The Roundtables are forums to learn the latest compliance/enforcement requirements and to get answers to your questions. Each month we cover a portion of the Food GMPs.
  3. If your customers are asking for Quality Management System enhancements to your food gas procedures, contact me.
“Compressed Gas Solutions has proactively been getting ready for the food gas legislation. We developed a different part number and lot number system to stand alone from our medical record keeping. The products affected are carbon dioxide, nitrogen, and gas mixtures of the same. At this point, we have had a few requests for Certificate of Conformance, but as time goes on I’m sure we will see more activity for documentation. We are familiar with the paperwork and the expectations since some are similar to the FDA Medical program.”
Allen Crews, Compliance Manager
Compressed Gas Solutions (Orlando, FL)
“County Specialty Gases has some work to do to meet the requirements. Currently our cylinders do not have barcodes, and we’ll be purchasing labels and adding software. It will be time-consuming to enter all the information into the system, and there will be a cost for the time, the labels, the software. I don’t expect it to be a big deal, as we already track medical cylinders. Our CO2 supplier is integrating the new GSH food grade labels onto their cylinders that we rent and onto our owned asset cylinders. For cylinders being rented and returned, we have to implement a process to keep track of the food grade gases that we send to our customer base, both the ones that we rent and the ones that we own and return to our vendor gas plants.”

Gary Dominguez, General Manager/Owner
County Specialty Gases (Redwood City, CA)

“We helped McDonald’s Corporation develop a set of standards that all McDonald’s corporate stores, franchises, and the distributors who supply them now must follow. O.E. Meyer was the first approved vendor for McDonald’s food gases. We keep a very clean place, but the McDonald’s standard took it to a new level. We have other national fast food chains, as well. Our supplier provides a Certificate of Conformance with every delivery documenting the CO2 as beverage grade. We receive one grade of product that is lot controlled and use it across the board, even for industrial, so there is no risk of pulling the wrong product. Whether it’s a beer gas cylinder or a cylinder delivered on our truck, it’s lot-controlled and there is traceability. Everything is scanned, so the record keeping is automated.”

Eric Wood, Sales Manager
O.E. Meyer Company (Sandusky, OH)

“The majority of nexAir’s customers are not asking what grade we provide to them, which I find surprising. Even though food grade product is equal to the International Society of Beverage Technologists (ISBT) specification, there is some demand in the market for specific ISBT CO2. Two plants produce nexAir’s gases; one is an ISBT plant, one is not. Not every CO2 plant is testing for ISBT product, and it’s now a matter of our becoming certified to test it when we pick it up. It’s a significant investment and we are in the process of determining if we should purchase the testing equipment or find a supplier with ISBT-spec’d product. Locating these plants is a huge undertaking. One of nexAir’s large customers requires the ISBT standard gas, and if we want to continue to support that customer, we have to be compliant across the board.”

Steve Atkins, Executive Vice President
nexAir (Memphis, TN)

Gases and Welding Distributors Association
Thomas Badstubner Meet the Author
GAWDA’s FDA & Medical Gases Consultant Thomas L. Badstubner is president of AsteRisk LLC in Lewisville, Texas. Members can reach him at 508-883-0927 and tom@asteriskllc.com.