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The New Language of Food Gases

The New Language of Food Gases


By Bob Yeoman

The US Food and Drug Administration (FDA)


is in the home stretch of finalizing a new and
This article examines some of the new language that
sweeping set of changes to food safety regula-
welding and gases distributors will need to learn in order
tions ushered in by the Food Safety and Mod-
ernization Act (FSMA), which was signed into
to adapt their business practices to new FDA regulations.
law in 2010. During the last six months of The FDA has felt public pressure for food bulk of these new food safety regulations,
2013, the FDA was busy publishing their view safety regulations building on two fronts. which will initiate the countdown to manda-
of the food safety world to come in the form of The US continues to experience major tory implementation.
new regulatory proposals for public review recalls of contaminated food products that As these new regulations start to phase in
and comment. During that same period, the are diligently reported in the media and keep they bring with them a new regulatory lan-
agency was holding public hearings to interact the public focused on food safety. Food guage rife with terms that will be unfamiliar
with the public and collect further comments safety advocates also continue to press court to many in the gases industry. This article
on many of their proposals. In the often actions that seek to have the FDA move examines some of the new language that
lengthy US regulatory process, public hearings faster on food safety regulations. Key mem- welding and gases distributors will need to
are usually one step — and sometimes the last bers of Congress are exerting their own learn in order to adapt their business practices
steps — before final regulations are issued. influence on agency executives to get these to new FDA regulations. While the focus here
new regulations implemented as quickly as is primarily on carbon dioxide and nitrogen,
possible. It is our expectation that by 2014 the same basic issues we discuss apply to all
and early 2015 the FDA will finalize the Food or Beverage Grade gases.
See “Changes Coming to the Food Supply
Chain,” CryoGas, May 2013, p. 40.

Food Grade vs. Beverage Grade Analytical Specification Comparison

Figure 1 Source: B&R Compliance Associates LLC

52 August 2014 — CryoGas International


The New Language of Food Gases

Many welding and gases distributors cur-


Redefining Food A PRODUCER AND SUPPLIER PERSPECTIVE
rently don’t even recognize they are in the
food business. While being in the food busi-
New FDA regulations for food are extensive and complex and will require gas producers to invest

ness may have been debatable in the past, the


more time and energy in their food and beverage gas manufacture and distribution processes.

coming FDA changes clarify the definition of


Food and will put many distributors squarely
CryoGas International spoke with Terry Scanlan, Strategic Customer Manager, Linde Gases and Sal

in the food business. Under FSMA the FDA


Calandra, Head of Quality & Food Safety for Linde NA, about the new FDA regulations and their

now defines food as “… a raw, cooked, or


impact on their food and beverage business. Calandra is also the Chair of the Beverage Gas Commit-

processed edible substance, ice, beverage, or


tee for the International Society of Beverage Technologists (ISBT) and the Food Gas Committee for

ingredient used or intended for use or for sale


the Compressed Gas Association (CGA). Linde is the world’s leading supplier of beverage and food

in whole or part for human consumption or


gases and related applications.

chewing gum.” This means that any gases


CryoGas: Are your customers asking about the difference between food and beverage grade gases?

used as ingredients in food or beverages are


Terry Scanlan: Yes — both the global food and beverage industries seek continuous improvement

themselves considered food. So, clearly car-


bon dioxide and nitrogen used to manufac-
and protections along the entire supply chain, from farm to fork. Today, both individual companies

ture beverages are now Food under Federal


and industry associations are driving the integrity of the food chain to ensure that the highest stan-

Law! It is also pretty obvious that gases sold


dards are applied universally. The food and beverage companies that operate on the retail front line

as Food Grade are clearly intended for use


with consumers are now holding their suppliers to even higher standards than before in order to

and for sale for human consumption, and that


mitigate food safety risks in the food chain. Industry Associations such as the Global Food Safety Ini-

now makes them Food under the law.


tiative (GFSI), CGA, and ISBT are examples where industry participants work together to develop

The FSMA’s definition of a Food Pro-


common standards, processes, and protocols.

cessing Facility broadens the scope of the


CryoGas: How does this manifest itself in the supply chain?

facilities which will be regulated under this


Terry Scanlan: We aim to focus more on understanding the specific customer’s requirements and

new law. Traditionally plants that did not fill


cylinders of Food Grade gases, but simply
then to mutually agree to the standards required to meet the quality and safety requirements for

stored and sold food gas cylinders filled by


that particular product. Linde recently made the commitment that all its Linde Food Grade carbon

someone else, were considered exempt from


dioxide production plants would align with the GFSI by gaining FSSC22000 certification. There also

the law. Under FSMA, the FDA defines a


is an education process with some customers. We educate customers and distributors about new reg-

Food Processing Plant as “… a commercial


ulations, such as FSMA, and also about the purity differences between Food Grade and Beverage

operation that manufacturers, packages,


Grade product as defined by industry associations such as CGA and ISBT.

labels, or stores food for human consump-


CryoGas: Have the new regulations caused changes in Linde’s supply chain for CO2 and nitrogen, espe-

tion, and provides food for sale or distribu-


cially in your production and distribution processes?

tion to other business entities…” So, unlike


medical gases where you must fill cylinders
Sal Calandra: The new regulations have caused minimal changes in our production or distribution

to be regulated by the FDA, when it comes


processes. This is partly because our key customers already require that we provide the intent of

to food the law now says that any facility


FSMA in advance of the regulations and in some cases obtain certification to a GFSI benchmarked

that simply stores Food Grade cylinders of


scheme, FSSC 22000. However, the real reason that the regulations had little impact is that safety,

gas is regulated under FSMA. In the sim-


including food safety, is a basic prerequisite for us and any business activity we undertake.

plest of terms this means that welding and


CryoGas: In 2010 Linde North America received FSSC 22000 certification for its nineteen beverage-

gases distributors that fill, sell, or exchange


grade carbon dioxide facilities. Does that certification impact Linde’s ability to meet new FDA rules

even an occasional CO2 cylinder for home


and regulations for food? If so, how?

beer carbonator units are selling Food, and


under FDA regulations are a food process-
Sal Calandra: Absolutely. The efforts to certify our CO2 plants enhanced our understanding of the

ing plant, even if someone else filled the


new food safety regulations and how they apply throughout our business. It has also caused us to

cylinders for them.


proactively implement a FSMA compliant food safety management system for very low food safety
risk products such as oxygen, nitrogen, and argon.
CryoGas: How are you educating your sales team about new regulations?

The next piece of new language involves the


Beverage Grade vs. Food Grade Terry Scanlan: Linde’s training is built around bringing awareness to the sales teams, both directly

various grades of gas currently being sold to


and through our distributor network. We are providing training to the various sales teams so that

food and beverage customers. Throughout


they are aware of the new industry regulations and how we might support our customer’s pro-

the industry we see the term “Food Grade”


grams. It is important for the Linde sales team to understand that Linde has internal teams in Quality

and “Beverage Grade” used interchangeably


by many companies, both gas suppliers and
and Supply that are available to assist the Linde customer. Supplying products and services is not

customers alike. However, Food Grade and


enough today; an education component also is important as the Linde customer seeks to understand

Beverage Grade gases are significantly dif-


how our programs fit into their processes in a complete, secure, and food safe supply chain.

ferent animals.
CryoGas: Thank you Terry and Sal for sharing your knowledge of food safety regulations and their
impact on the food and beverage business with our readers.

August 2014 — CryoGas International 53


The New Language of Food Gases

The Compressed Gas Association (CGA) standard and update their carbon dioxide tion is much more stringent for Beverage
(cganet.com) is responsible for some of the specification to reflect today’s market place Grade. While some of these differences are
confusion around Food and Beverage Grades reality, which is that CGA Grade I/ISBT small they have been shown to be highly
in our industry with their standards. For Guideline is the appropriate and only important. This is because Beverage Grade’s
example, CGA Grade H for carbon dioxide is acceptable specification for Beverage Grade tighter analytical specifications are an evolu-
called “Food Grade,” and conforms to the carbon dioxide. The same issue will have to tion of customer requirements derived from
Food Chemical Codex (FCC) analytical spec- be dealt with for the Beverage Grade nitro- actual testing on the effect of carbon dioxide
ifications for that product. CGA Grade I for gen specification once it is finally released contaminants on product quality performed
carbon dioxide is called “Beverage Grade” by ISBT. by the beverage industry. The results of these
and conforms to the International Society of There are significant differences in the tests concluded that the contaminant levels
Beverage Technologists (ISBT) analytical carbon dioxide product quality specifications acceptable in Food Grade product can cause
guidelines. The confusing part comes from between Food and Beverage Grades. For significant problems, such as inducing unde-
the same CGA publication which also states example, the analytical specification for sired tastes or odors, when used to carbonate
that Grade H is acceptable to carbonate bev- Food Grade CO2 has a minimum purity of high quality beverages.
erages, which effectively creates two Bever- 99.5 percent, and includes testing mainly for
age Grades. common/traditional CO2 contaminants. On
While the gas industry appears to be con- the other hand, the analytical specification Like medical gases the pedigree for Food
Product Pedigrees

fused about which grade of CO2 to use for for Beverage Grade stipulates a minimum and Beverage Grade products starts at the
beverages, the major beverage firms have purity of 99.9 percent and includes a broader bulk supplier. Firms selling Food Grade
made it quite clear they now only accept range of contaminant tests. Even more gases, under Federal law, must have, at a
Grade I for use in carbonating their prod- important, for most of the contaminants the minimum, a documented “Food Grade”
ucts. It is time for CGA to eliminate this dual two grades share in common the specifica- pedigree back to the bulk supplier. Like-

Figure 2 Source: B&R Compliance Associates LLC

54 August 2014 — CryoGas International


The New Language of Food Gases

wise, firms selling “Beverage Grade” must


be able to document a Beverage Grade
A DISTRIBUTOR’S PERSPECTIVE
pedigree back to the bulk source. While not
as widespread a practice as a few years ago,
FDA is in the final stages of delivering new food regulations, which will usher in a new language that

there are still firms that purchase industrial


distributors of Food and Beverage Grade gases will have to learn. While gases distributors would pre-

grade carbon dioxide, but sell Food and


Beverage grades of that product once it is
fer to have these new requirements and associated language delivered as part of one clear document,

put into cylinders. FSMA will allow firms


law, or regulation, this is not the case. FDA is following the Federal Rulemaking Process of Notice and

to downgrade carbon dioxide with a Bever-


Comment they use to introduce all new regulatory requirements. This is a top down driven process

age Grade pedigree and sell it as industrial


with information being delivered to the public via the published rules, FDA guidance documents, and

grade, but the reverse will be illegal. In


public hearings to collect comments. Distributors who do not regularly read the Federal Register may

other words, to sell Food Grade carbon


only find out about new regulations when FDA comes to visit sometime in the future.

dioxide in cylinders you have to start with


These new regulations are extensive and complex, and will require firms to invest more time and

bulk product that was manufactured and


energy into the Food and Beverage gas manufacture and distribution processes. It will also require

delivered to you as Food Grade. The same


learning or tapping into additional expertise to build and manage a compliant food and beverage

holds true for Beverage Grade.


distribution operation.

Understanding these various requirements


CryoGas International spoke with Craig Wood, President of O.E. Meyer, a successful Midwest

is all part of developing a common language


distributor of industrial, medical, a specialty gases — including food and beverage gases — about

around Food Grade vs. Beverage Grade.


Welding and gases distributors need to under-
the new FDA regulations and their impact on his business.

stand that when providing one of these two


CryoGas: When we profiled O.E. Meyer in our magazine (“O.E. Meyer: A Company on the March in

grades of gases it is not just the purity speci-


Midwest Markets,” CryoGas, August 2012, p. 47), you reported that you saw a lot of opportunity to

fication that defines the grade. The definition


grow your share of the beverage market with liquid CO2 microbulk delivery. Has this worked out well

of the grade also involves the contaminant


and have the new FDA regulations slowed the process.

testing and the ability to trace the product’s


Craig Wood: Our microbulk CO2 business is gaining traction, yes. We already had well-defined

pedigree back to the source. Selling Beverage


Standard Operating Procedures (SOP) in place for FDA compliance in regard to our medical gases

Grade gases means there is a larger set of


business and now we have the same for beverage CO2. So operationally, from a regulatory compli-

product expectations involved than just pro-


viding a Certificate of Analysis with the
ance perspective, we are well-positioned to meet the new FDA requirements for beverage CO2 for

words “Beverage Grade” on it.


our customers and to grow our CO2 beverage business. Regulations will not slow us down.
CryoGas: How is FDA compliance regarding food and beverage managed at your company?
Craig Wood: We have a dedicated internal compliance officer for beverage gases and an associ-

Another new acronym being introduced by


The Rise of Risk Assessments ated team of people in charge of meeting all regulations, including those of the FDA. As I mentioned,

the Food Safety and Modernization Act is


O.E. Meyer already had in place a compliance program, managed by B&R Compliance, for our medical

Hazard Analysis and Risk Based Preventative


gases business. Together with Bob Yeoman and his team, we used this as the template to develop a

Controls, or HARPC. This concept of assess-


similar SOP for beverage CO2. This will enable us to meet all new regulations going forward. Along

ing risk and basing your controls on managing


with working with B&R Compliance, the benefits of being a Linde Platinum Distributor has signifi-

those risks to Food Safety is the centerpiece of


the FDA’s new regulatory approach to regulat-
cantly expedited the process of developing a well-rounded program. O.E. Meyer is fortunate to have

ing food. HARPC is a seven step process,


the experience and resources to develop a really strong beverage compliance strategy.

which is outlined in the Figure 2. (I will be


CryoGas: Thank you Craig. We appreciate the insight you bring to this discussion.

covering HARPC in more detail in a future Once FSMA takes full effect, every food February 2014, the FDA introduced a new
article in CryoGas International.) facility in America will be required under Food Defense rule requiring firms to address
The whole HARPC process begins, ends, Federal Law to conduct and document a intentional sources of contamination in their
and is guided at each of the seven steps by HACCP risk assessment. When conducting risk assessment. This means firms must con-
a focus on hazard and risk identification and that assessment firms must consider physi- sider the potential for a third party seeking to
management. The tool for assessing risk cal, chemical, biological, and radiological intentionally introduce a food safety hazard
favored by the FDA is HACCP, which sources of food safety contamination (risks). or contaminant into their product and how
stands for Hazard Analysis of Critical Con- The risk assessment must also assess points the firm can best detect and defend against
trol Points. We predict HACCP is yet in the manufacturing process where food that issue.
another acronym that distributors in the safety risks can be introduced or become
food business should expect to become inti- concentrated. Finally a risk assessment will
mately familiar with over the course of the determine the process points where Food Using the output of risk assessment, firms
Food Safety Plans

next few years. Safety hazards can be eliminated or con- will be required to create a food safety plan.
trolled to an acceptable level. In just the last The term food safety plan is somewhat of an
few months the FDA has added to the list of acronym itself. Food safety plans will outline
food safety risks that must be considered. In the relevant hazards and risks and spell out
See “Changes Coming to the Food Supply
Chain,” CryoGas, May 2013, p. 40.

August 2014 — CryoGas International 55


The New Language of Food Gases

the framework for addressing them. The plan the company to conduct these reviews. The changes to the HARPC plan must be approved
will outline the firm’s detailed approach to FDA is establishing regulations setting out by the QI and plans need to be reviewed and
assessing and controlling identified risks and minimum educational and experience require- reapproved every three years at a minimum.
hazards. The plan also will incorporate the ments that a QI must possess in order to con-
mandated food safety prerequisite programs duct these reviews and grant plan approval. QI
for compliance with the various FSMA criteria is expected to be a blend of training The new language of food and its associated
Be Prepared

requirements, such as product traceability, and experience in HACCP execution, knowl- acronym’s will soon be part of the day-to-
recall, employee training, process documen- edge of Food Safety Regulations, and experi- day dialogue in the gases industry. Teaching
tation, etc. For many distributors already in ence in food safety auditing combined with a the industry and our customers the differ-
the gas business, elements of their food safety background in the food industry. The FDA has ence between Food Grade and Beverage
plan might resemble sections of their medical made it very clear in the FSMA language they Grade — and how to recognize that differ-
gas manual, such as product lot numbering. do not expect smaller firms to have the capa- ence — is vital to preserving our industry’s
Other elements, such as the risk assessment bility to create their own QI. They also antici- well-deserved reputation for safety in the
output and the actual food safety plan will be pate some firms may not be willing to invest public interest. Our industry needs to make
items new and unique to those firms. the necessary time, effort, and money to train a sure going forward that the term “Safety”
Medical gas manufacturers and firms with QI to meet their criteria. As a result, the FDA also includes “Food Safety” when referring
an ISO certification will already be familiar built into FSMA the ability for smaller firms to to Food and Beverage Grade gases. B&R is
with managing and approving procedures for use a third party as their Qualified Individual already well ahead of the curve in FSMA
their business. Under FSMA, the FDA takes to do reviews and approvals for them. In fact, compliance and is prepared to assist your
this process to a whole new level. Every food this is very likely the FDA’s preferred company learn this new food safety lan-
safety plan must be reviewed and approved by approach for small- to medium-sized firms. In guage. For questions on food safety, medical
a Qualified Individual (QI), which is yet all likelihood most firms will end up forming a or industrial gases, or bulk systems at
another new acronym in the Food Safety lexi- long-term relationship with their QI, as, in healthcare facilities give us a call or drop us
con. QI cannot be just anyone designated by addition to the initial plan approval, any a line. n

Bob Yeoman is President and CEO of B&R Compliance Associates LLC (Lehigh Valley, PA), a consulting firm specializing in
medical gases, safety management, and other regulatory compliance management issues relating to the compressed gas industry.
He can be reached at (610) 868-7183; Email bob.yeoman@brcompliance.com.

56 August 2014 — CryoGas International