The document discusses the development and launch of Omission Beer, the first gluten-free beer made from barley in the US. It was created by Widmer Brothers Brewing Company using a proprietary process to remove gluten from barley. While tests show the beer contains less than 6 parts per million of gluten, some experts have reservations about whether tiny gluten fragments could remain undetected. For the beer to be labeled gluten-free and distributed more widely, regulators would need a validated test to distinguish safe from unsafe levels of gluten in fermented beverages.

1. GF BARLEY BEER
It's here, but is it Safe? | byAmy Ratner
A
n Oregon brewery has launched the first
"gluten-free" beer made from barley in
the US. The Craft Brew Alliance recently
introduced Omission Beer, named to high-
light the brewer's claim that the beer is missing the glu-
ten protein harmful to those who have celiac disease.
The beer is brewed by Widmer Brothers Brewing
Company, which worked for six years to develop a beer
made from barley but processed to remove gluten. The
beer is tested using the best test available to measure
the gluten content of beer and routinely comes in below
6 parts per million, according to Joe
Casey, Widmer's brew master. Cur-
rently it is sold only in bottles and
is only available in Oregon where
it is being widely distributed in
supermarkets, health food stores
and restaurants.
Terry Michaelson, CEO of the
brew alliance, found out he had
celiac disease 12 years ago and
Casey's wife was diagnosed in
2006. Michaelson and Casey
said they were on a personal
mission to craft a gluten-free
beer that had the malty flavor
of traditional beer.
"The launch of Omission
Beer is a game changer for
those who have celiac disease
and the craft beer commu-
nity," Michaelson said.
He pointed to test results
available to consumers for every bottle of Omission
beer as proof that their commitment and hard work have
paid off in a beer that is safe for gluten-free consumers.
The beer is made with a proprietary brewing process
that reduces gluten content from the purchase of raw
materials through the finished product.
Eurofins, an independent lab that is a world leader in
food analytical testing, tests the beer using the Com-
petitive R5 ELISA test. The beer label says the beer
contains less than 6 ppm of gluten.
Celiac disease and gluten-testing experts arc taking
a close look at the beer and acknowledge it might be
acceptable on the gluten-free diet. But they are not yet
ready to give it a green light for those with celiac dis-
ease. There is concern that tiny fragments of harmful
gluten, called peptidcs, might remain undetected in the
beer after it is fermented.
"When barley is used to make beer, the results of the
Competitive R5 test are not sufficient to fully document
that the beer is safe for (those who have celiac disease)
even when the test results indicate no detectable glu-
ten peptides," said Steve Taylor, PhD, co-founder and
director of the Food Allergy Research and Resource
Program at the University of Nebraska. "While the
(specific) peptides detected by the Competitive R5
are not present at detectable levels, other gluten pep-
tides might be present and their safety may not be fully
proven. These beers are likely safer than other barley-
based beers, but we do not seem to have sufficient
information to conclude that they are completely safe".
The Competitive R5 assay seems to be a good com-
mercially available test to detect gluten in barley-based
beer, said Donald Kasarda, PhD, a cereal chemist and

2. HOW BARLEY BEER ISBREWED
Although the process usedto remove gluten from malted barley in Omission Beer is propri-
etary, here's what we do know:
• The beer begins with malted barley, hops, yeast and water.The
brewery, Widmer Brothers Brewing, looks for raw grain that has low
protein content. Brew Master Joe Casey said protein works against
brewers so they always look for low protein ingredients. And in this
case low protein is paramount.
• In the brew house, proteins are degraded and/or removed entirely
through precipitation, denaturation and sedimentation.
• Omission comes in Pale Ale, which ferments for one week, and Lager,
which ferments for two. After fermentation, yeast, solids and proteins
are removed using a centrifuge and filter.The beer is then sent to a beer tank
• Before bottling, each beer tank is initially tested for gluten using a rapid
test. Only beer that has no detectable gluten is bottled and additional, more
precise testing follows.
• Samples of bottles from each tank are sent to a third party lab for testing
with the R5 Competitive ELISA test. Bottles from every batch are held in the
warehouse for 21 days until test results are complete. Any beer that isdeter-
mined to contain detectable gluten above 6 parts per million is destroyed.
• Labels on the bottles saythe beer contains less than 6 parts per million of gluten.
• Omission is made on equipment also used to make gluten-containing beer. Casey said
the equipment is aggressively cleaned and sanitizedto minimize the risk of crosscon-
tamination, "I have faith in the cleaning process," he said. "We don't pasteurize our beer
so we have to make sure it is clean or we would have microbial infection."
• Omission is only availablein bottles to avoid any cross contamination in draught beer
tap lines.
• Consumers can go online, omissionbeer.com, to check test results for specific bottles of
Omission by entering the date code on the label. Casey said consumers can use a
smart phone right in the store to check results before even making apurchase.
Craft Brew Alliance was created through the merger of three Pacific Northwest craft
brewers, including Widmer. Brewing giant Anheuser-Busch owns one third of alli-
ance's stock and has a major distribution agreement with the smaller brewer. An-
heuser Busch is a familiar name in gluten-free beer circlesthrough its sorghum-based Red-
bridge-beer, which is available nationwide.
Terry Michaelson, Alliance CEO,said more specific details of steps taken to remove gluten
protein from Omission brand will eventually be available.
"A lot of things we have done in certain ways to make sure Omission is safe,"
he said. "I not sure this company would have (attempted gluten-freebarley beer)
if the CEOand brew master did not have a connection. It is difficult and there are
barriers."
But in the end Michaelson said he is confident the brewery has achieved its goal of
making a delicious craft beer that can be enjoyed by beer drinkers, gluten free or not.
38 www.glutenfreeliving.com

3. respected expert on grains and their relationship to ccliac dis-
ease.
Rut he said he still has some reservations about using it to
decide if heer is safe. "There is a potential problem with the
assumption that the R5 antibody will recognize all toxic pep-
tides in a protein digest, as is the case in beer, in the same way
that it recognizes intact proteins," Kasarda said.
Still he said "a good competitive assay result using the R5
antibody may well be correct."
Cynthia Kupper, RD, executive director of the Washington-
based Gluten Intolerance Group, said the group's Gluten-Free
Certification Organization has been approached aboutcertifying
barley-based beer. She said documentation from the beer maker
suggests it may be safe but it's still not certain. Asked if the beer
could pass GFCO tests, Kupper said, "That is a tough question
and one that we aren't able to answer at this time. We have a
number of factors to consider beyond testing results."
One of those factors is how barley-based beer is regulated.
Gluten-free beer made from gluten-free grains like sorghum and
rice fall under thejurisdiction of the Food and Drug Administra-
tion and can be labeled gluten free.
But beer made from malted barley and hops that is sold across
state lines has to meet requirements set by the Alcohol and
Tobacco Tax and Trade Bureau (TTB). The bureau docs not cur-
rently allow gluten-free labeling on any beer it regulates. Omis-
sion can be labeled gluten free because it is only sold in Oregon
and is licensed under state laws.
Michaelson said the brewery would like to expand distribu-
tion and the TTB is reviewing label language that would allow
brewers to describe steps taken to reduce gluten content.
But a gluten-free label faces a big hurdle.
Tom Hogue, TTB spokesman, said the FDA in the process
of trying to come up with a definition for use of the gluten-free
label on products it regulates. He notes there is "no scientifically
validated test for gluten in fermented products."
"That presents a major difficulty when trying to determine
what sort of gluten claims to allow on labels. Currently, TTB
is not approving gluten claims on labels for malt beverages,"
Hoguc said. "If you want to make a quantitative claim, we need
to see a scientifically validated test. At this point there is no
test."
Taylor said he largely agrees with the TTB. "My position is
that the Competitive R5 can be used and yields results that are
of some value. But that is not the same as indicating that it
is a validated test capable of distinguishing between safe and
unsafe," he said.
Michaelson at press time said a new validation study of the
Competitive R5 test is due to be published in the next few weeks.
Meanwhile, he said, several leading international allergen detec-
tion and gluten experts agree the test is the best method for test-
ing gluten levels in fermented beverages that contain hydrolyzed
gluten. Barley-based gluten free beer is availableinternationally
because the science behind its safety is accurate, according to
Michaelson.
"The ability to measure gluten levels in fermented products
made from malted barley is a relatively new scientific develop-
ment and is an evolving science," Michaelson said. "Once all
research, data and informationabout the testing method and that
study have been reviewed, we are optimistic that there will be
appropriate data for the FDA and TTB to validate the R5 Com-
petitive ELISA test domestically."
A recent Australianstudy of the gluten content of beer using
mass spectrometry instead of the Competitive R5 ELISA found
that two barley-based beers that claim to remove gluten through
special processing contained as much gluten as regular beer.
But the beers were not named and results were reported in a way
that some gluten-testing experts said was difficult to interpret.
Health Canada, the Canadian regulatory agency, is also report-
edly looking into the use of mass spectrometry to assess the
gluten-free status of beer.
Barley-based gluten-free beer is made in'other countries
including Spain, Germany, Finland, Belgium and the United
Kingdom. But there is some question whether gluten-free
consumers in the US will accept a beer brewed from a gluten-
containing grain even if the testing issues are resolved. Barley
has always been strictly forbidden on the gluten-free diet and it
could prove hard to overcome that taboo.
Kupper said that if products with processed barley can be
proven to be truly gluten free, support groups like hers face the
challenge of educating the gluten-free community that "things
have changed and what we thought was not safe can be safe."
She added, "We have to...help consumers accept new and
advanced food technology which will loosen the restrictions we
deal with every day."
Michaelson recognises there could be con-
sumer hesitation about barley beer. "I understand
there will be a lot of questions. 1understand there
will be skepticism," he said.
But Kupper has seen some evidence that when
it comes to beer, gluten-free consumers might be
a more accepting audience. At an international
celiac disease meeting in New York City, gluten-
free consumers didn't hesitate to sample a foreign
barley-based beer. In fact, a lot went back for sev-
eral more sips.
As for barley-based products available for sale
in the US, Kupper said she's been told some peo-
ple are "already drinking it and loving it."
www.glutenfreeliving.com 39