June 22, 2012

Transcription

June 22, 2012

Food Chemical News Week in Review
June 22, 2012 / Volume 54, Number 14
News
Food Chemical
June 17, 2011
Quote of the Week:
“This is not your father’s Farm Bill.”
-- Sen. Debbie Stabenow (D-Mich.), chairman of the Senate
agriculture committee (see related article, Page 1).
Weekly in-depth coverage of food regulations, additives, microbiology, contaminants and feed
FDA will not enforce FSMA preventive controls next
month, Taylor clarifies in letter to GMA
By Joan Murphy
F
DA will not be enforcing the FDA
Food Safety Modernization Act’s
preventive control rules until they
are finalized, FDA Deputy Commissioner
for Foods Mike Taylor assures in a
letter sent Monday to the Grocery
Manufacturers Association.
The food industry has been looking for
guidance from FDA on its timeline for
enforcing the preventive controls because
the law says they go into effect July 3, 2012.
But the two rules, which went over to the
Office of Management and Budget on Nov.
22, 2011 (food preventive controls) and Dec.
5 (feed preventive controls), are among four
FSMA provisions that OMB has been sitting
on for months, leaving the industry unclear
about FDA’s compliance schedule.
Seventeen trade associations
encouraged Taylor, in a letter sent May
In This Issue
CODEX10
Codex opponents of ractopamine and
zilpaterol show no signs of yielding
FDA backs off dietary supplement
guidance INTERAGENCY12
House committee rejects $50 million
more for FDA food safety, won’t spare
MDP
PESTICIDES20
Farm group says “Dirty Dozen” list
contributes to obesity problems
2
final, will contain provisions that clarify
industry’s responsibilities and will foster
compliance with FSMA’s new requirements
in an orderly and effective manner. FDA will
expect to enforce compliance with these new
FSMA requirements in timeframes that will
be described in the final rules,” he says.
Taylor adds that other food safety
provisions for human and animal food
remain in effect. “If we find a food that
poses a public health risk to humans
or animals, or if an inspection reveals
a facility operating under insanitary
conditions or otherwise failing to operate
safely, we will continue to take action
as appropriate under the [Food Drug &
Cosmetic] Act,” he says.
In response to the Taylor letter, GMA
issues the following statement: “The letter
issued by FDA recently on matters of
►FSMA,
►
continues on page 11
Senate barrels through long list of
amendments preparing for Farm Bill vote
By Amber Healy
FDA11
Full Contents
30, to issue written guidance as soon as
possible on the timeline for enforcing
FSMA’s preventive control provisions (see
FCN, June 15, 2012, Page 3). The onepage letter Taylor sent to Leon Bruner,
GMA’s senior vice president for scientific
and regulatory affairs and chief science
officer, seeks to clarify FDA’s next steps:
http://www.agra-net.com/content/agra/ips/
pdf/GMA%20Enforcement%20Letter.pdf.
“Your letter was prompted by the
approaching statutory effective date of
July 3, 2012, for the preventive controls
provision,” Taylor says, referring to an
earlier May 7 letter from Bruner. “FDA is
committed to full and timely implementation
of FSMA and will be issuing proposed rules
to implement sections 103 [dealing with
FSMA’s Hazard Analysis and Risk-Based
Preventive Controls provision] and 301
[dealing with FSMA’s Foreign Supplier
Verification Program]. Those rules, when
T
he Senate discussed insurance no
less than seven times this week
while going through a list of 73
proposed amendments to its version of the
2012 Farm Bill.
Among the amendments that will be
included: a provision, offered by Sen.
Dianne Feinstein (D-Calif.), or otherwise
that would create an insurance program for
farmers whose crops were wrongly linked
with or otherwise affected by a recall or
illness outbreak. The amendment, which
was adopted by a 76-23 vote, one of the
largest margins of approval, directs USDA
to conduct a pilot program to determine the
feasibility of such a program and does not
add to the Farm Bill’s overall cost of $969
billion.
Another insurance-related amendment
that has the organic industry excited is
one offered by Sen. Jeff Merkley (D-Ore.)
that would provide crop insurance to
organic farmers in a fashion equivalent to
insurance provided conventional farmers.
As it is, organic farmers currently pay a
higher premium than conventional crops
for Federal Crop Insurance Corporation
coverage, but receive reimbursements at a
►Farm
►
Bill, continues on page 14
June 22, 2012
ADDITIVES...................................................... 5
Gruma, March of Dimes among groups
seeking approval for folic acid in corn masa
flour................................................................... 5
Trade group says EU additive approvals
system is working............................................. 5
BIOTECHNOLOGY........................................... 6
BIO and ASTA draft agreement to deal
with patent expiration issues............................. 6
Political obstacles to biotech food a recurring
theme at BIO convention in Boston.................. 7
EU biotech cultivation proposals appear dead
in the water ...................................................... 8
European Commission investigates rice
imports from India ........................................... 9
CODEX...........................................................10
zilpaterol show no signs of yielding............... 10
FDA................................................................11
FDA backs off dietary supplement guidance .11
INTERAGENCY..............................................12
House committee rejects $50 million more
for FDA food safety, won’t spare MDP.......... 12
EPA changes Clean Air Act standards for
soot but leaves dust unchanged....................... 13
INTERNATIONAL...........................................16
U.S. dairy industry excited about Canada and
Mexico joining Trans-Pacific Partnership....... 16
EU poised to allow lactic acid treatment for
meat carcasses................................................. 16
LABELING & ADVERTISING.........................17
FDA plans eye-tracking study to test
consumer reaction to food labels.................... 17
CSPI: Girl Scouts sell cookies, not candy
bars.................................................................. 17
Peruvian industry strikes back at proposed
food advertising restrictions ........................... 18
PACKAGING..................................................19
EFSA says mineral oil hydrocarbon safety
limits need revision......................................... 19
PESTICIDES..................................................20
Farm group says “Dirty Dozen” list
contributes to obesity problems...................... 20
USDA.............................................................21
USDA seeks “temporary” inspectors to help
expand HIMP.................................................. 21
FSIS extends comment period on draft
validation guidance......................................... 22
ON THE FRONT BURNER..............................23
10 Labeling Mistakes Importers Most Often
Make When Trying to Get Food into the
United States................................................... 23
2
Editor’s View: DONKEYS & ELEPHANTS
I
’ve spent nearly
half of my life
writing or editing
articles about federal
regulation. So, it is with
quite a bit of shame that
I admit to you today
that I don’t understand
politics. Or, more accurately, I don’t
understand bipartisanship.
I say this as I read the study published
recently by the consulting group Foodminds
on the different attitudes about food regulation
maintained by Democrats and Republicans.
Foodminds surveyed roughly 1,000 people in
late April and asked them for their opinions
on more than a dozen food-related issues.
How do you feel about labeling foods that
have GM ingredients? More than half (58%)
of the Democrats responding to this question
said they strongly favor such labeling and
12% said they strongly oppose it, while just
38% of Republicans strongly favor such
labeling and 17% strongly oppose it.
On whether government should tax
consumers for buying soft drinks, 27% of
Democrats said they were strongly in favor of
the measure and 16% were strongly against it,
while 14% of Republicans strongly favor such
a measure and 46% were strongly against it.
But here was what I thought was the most
telling result: Foodminds asked who holds
responsibility for making healthy choices to
prevent obesity. Though 11% of both groups
felt food companies were most responsible,
48% of Democrats blamed the individual
compared to 67% of Republicans. Interestingly,
18% of Democrats blamed the U.S.
government, compared to 11% of Republicans.
Of course, Foodminds forced survey
participants to pick only one person or
organization to blame. I’m sure many of
us would list more than one and include
ourselves if we could.
But, if the GOP is right, that’s a bad sign
for America, because – as individuals –
two-thirds of us who are either overweight
or obese really have one person to be angry
with: The person in the mirror.
Jason Huffman, Editor in Chief
Food Chemical News
P.S. For more on the Foodminds survey,
go to: www.foodminds.com/wp-content/
uploads/Food-Temperance-in-AmericaSurvey-Deck-April-20121.pdf
Editor-in-Chief Jason Huffman
703-527-1680, ext. 116
jason.huffman@informa.com
Top 10 on the Web
01.House committee rejects $50 million
more for FDA food safety
02.House subcommittee urges FDA to limit
menu labeling, supplement guide
03.Stakeholders share strategies at summit
to curb soda consumption
04.EU poised to allow lactic acid treatment
for meat carcasses
05.CSPI: Girl Scouts sell cookies, not candy
bars
06.Senate works to narrow down some 300
Farm Bill amendments
07. USDA seeks “temporary” inspectors to
help expand HIMP
08.Nearly half of proposed Farm Bill
amendments discussed on floor
09.Trade group says EU additive approvals
system is working
10.R-CALF USA issues fourth request for
comment on BSE proposal
www.foodchemicalnews.com
FOOD CHEMICAL NEWS STAFF
Contents
Senior Editor Stephen Clapp
703-527-1680, ext. 121
steve.clapp@informa.com
Assistant Editors
Joan Murphy
443-994-7773
joan.murphy@informa.com
Amber Healy
703-527-1680, ext. 109
amber.healy@informa.com
Production Consultant
Peter Storey
+44 (0)20 7017 7561
peter.storey@informa.com
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© Informa Ltd 2012
June 22, 2012
Beltway Notebook
EXPENSIVE!
and “undetermined” risk. APHIS said in
Could the food defense requirements in
releasing its proposed rule that it would
the FDA Food Safety Modernization Act
base its import policy for a particular
prove to be the most costly for industry?
country on its risk classification as
The Grocery Manufacturers Association
determined by OIE’s evaluation (see FCN
warns this could be so.
May 18, 2012, Page 23).
FSMA section 103 requires that
While the comment period for the rule
preventive control plans address hazards
was reopened for a short period after the
involving intentional adulteration. At the
initial deadline, it didn’t provide enough
June 5 meeting of the Association of
Food and Drug Officials (see FCN
June 15, 2012, Page 12), Warren
Stone, GMA’s science policy director,
warned the food defense regulation or
guidelines “may well turn out to be
“This is not your father’s Farm Bill.” -- Sen.
the most expensive part of food safety
Debbie Stabenow (D-Mich.), chairman of the
compliance,” especially for small- to
Senate agriculture committee (see related
mid-size companies that have never
article, Page 1).
developed food defense measures,
according to Stone’s presentation
outline, which was made available this
week by AFDO.
The problem is companies may be
time for the public to review and comment
staffed with food safety experts, but there
on such a comprehensive proposed
are few security professionals in the food
rule, R-CALF says, speculating that
industry. Food defense responsibilities
USDA “is ignoring the multiple requests
are usually handled by food scientists and
for extension, because upon thorough
other food safety personnel with little or
review the public will see the proposed
no background in security, he said. In fact, rule as corrupt and dishonest. These
FSMA mentions deterrence of intentional
deceitful tactics might not be noticed
adulteration 11 times in five sections of the if organizations and individuals do not
law, he added.
have adequate time to carefully read and
respond.”
R-CALF USA requests that USDA
MORE BSE COMMENTS,
extend the comment period again, this
PLEASE
time for at least 60 days, following the
R-CALF USA, an independent cattlemen’s completion of USDA’s epidemiological
organization based in Billings, Mont.,
investigation of the recently detected BSE
on June 13 sent a letter to Agriculture
case in California.
Secretary Tom Vilsack requesting another
In the letter, R-CALF USA CEO
extension of the public comment period
Bill Bullard says the proposed rule “is
for the proposed rule titled “Bovine
riddled with inconsistencies, contradictions
Spongiform Encephalopathy; Importation
and outright lies.” He adds that USDA
of Bovines and Bovine Products.” This is
“has perjured itself in its pursuit of
R-CALF’s fourth request for an extension, [Vilsack’s] political agenda to expose U.S.
the group says in a news release issued
cattle and the public to an increased risk
June 14, when the comment period closed. of BSE.
Under the rule proposed in March,
“Your agency is wholly lacking in
USDA’s Animal and Plant Health
accountability, creditability, and integrity.
Inspection Service would adopt the
It is impossible for the public interest to
same criteria and categories that the
even be considered, let alone protected, by
World Organization for Animal Health
an agency that resorts to outright lies in
(OIE) uses to identify a country’s BSE
order to further its own political agenda,”
risk status: “negligible,” “controlled,”
the letter states.
Quote of the Week:
© Informa Ltd 2012
GMA BOLSTERS FOOD
SAFETY EXPERTISE
The Grocery Manufacturers Association
last week announced the appointments
of Melinda Hayman as director of
microbiology and William Koshute as a
scientist in chemistry.
Hayman is a food microbiologist with
more than 10 years of experience
specializing in food safety, including
government and industry appointments,
GMA says in a news release issued
on June 11. Most recently, she served
as director of technical services at
Food Safety Net Services (FSNS),
where she managed laboratory quality
systems, training, method validation,
and special projects. She received her
bachelor’s degree in microbiology and
biochemistry from the University of
Sydney, Australia, and PhD in food
science from the Penn State University.
Koshute most recently served as a
pharmaceutical research scientist for
Sanofi-Aventis in analytical support for
new drug applications. He has extensive
experience in the areas of method
development and validation, protein
purification, immunodiagnostics and
food biotechnology. He holds bachelor
of science degrees in chemistry and food
science from Drexel University and a
master of science degree in chemistry from
Tufts University. He began his duties on
April 17.
GLOBAL FOOD SAFETY LAB
Boston-based Waters Corporation has
teamed with the UK-based Food and
Environment Research Agency (FERA)
to open a new global food safety training
facility, in York, England, EU Food Law
reports.
The opening of the new laboratorybased unit follows a European
Commission report highlighting a dramatic
increase in food safety incidents in the EU.
The rise in incidents parallels the rise in
food sourced from non-EU countries, such
as India and China.
Sara Stead, strategic business
development manager in the food
3
June 22, 2012
Beltway Notebook
and environment division of Waters
Corporation, says participants will be
trained to comply with EU legislation,
but the facility will be open to people
from any country. Courses will focus
on detecting chemical contaminants,
and preparing and testing samples to
allow scientists to validate and use
results to determine whether food is
safe.
The laboratory is the first of several
planned around the world by Waters
Corporation and could contribute
reduction of food waste, EU Food Law
comments. Because up to half of the
world’s food supply is wasted between
farm and fork, better food safety training
can be expected to contribute to reducing
that figure. In Spain, mountains of
cucumbers had to be destroyed last year
when German authorities wrongly pointed
the finger of blame at cucumbers for the
widespread E. coli outbreak (see FCN July
22, 2011, Page 11).
SONIC LATEST FAST FOOD
CHAIN TO BAN CRATES
Sonic Corp., a 3,500-establishment
fast-food chain known for waiters on
roller skates, has joined the ranks of
Wendy’s, McDonald’s and Burger King
in announcing its intentions to eliminate
the use of gestation crates from its pork
supply.
The company announced on Monday its
goal of eliminating the metal confinement
systems by 2022, although the company
wants to be crate-free by 2017, the
company says in a statement posted on its
website, www.sonicdrivein.com. “Sonic
will continue to favor suppliers that raise
hogs in a gestation crate-free environment
in addition to suppliers that can provide
audit and tracking reports for sourcing
To subscribe...
4
crate-free pork,” the company says.
Paul Shapiro, vice president of farm
animal protection with the Humane
Society of the United States, which has
been leading the efforts against gestation
crates, says his organization is looking
forward to working with Sonic in this
endeavor.
PRE-MARKET TESTING OF GE
INGREDIENTS
The American Medical Association on
Tuesday called for mandatory pre-market
safety testing of all genetically engineered
foods, instead of voluntary testing by
industry.
To the Grocery Manufacturers
Association, this constitutes a vote in
support of the continued use of GE
ingredients in food and beverages, while
the Truth in Labeling Coalition sees it as a
victory for consumers who want to avoid
those ingredients.
“We applaud the AMA for taking the
lead to help ensure a safe and adequate
food supply,” TLC spokesperson Anne
Dietrich says.
Michael Hansen, senior scientist
with Consumers Union, released a
statement Tuesday commending AMA
for its decision, but added that he is
“disappointed that AMA did not also
support mandatory labeling…Studies in
the scientific literature have suggested
that genetic engineering could introduce
new food allergens, increase the levels of
known allergens, raise or lower nutrient
levels and have adverse effects on the
animals that eat such foods.”
But GMA took something different out
of AMA’s decision.
GMA released a statement Wednesday
in support of AMA’s decision, saying
“We commend the American Medical
Association’s House of Delegates for its
vote in support of the continued use of
genetically engineered (GE) ingredients
in the food supply. Today’s action is in
line with the position of the U.S. Food
and Drug Administration and numerous
regulatory and scientific bodies that agree
that foods and beverages that contain
GE ingredients are safe and materially
no different than those foods that do not
contain GE ingredients.”
CONSUMERS WANT
DRUG-FREE MEATS
A new poll conducted by Consumer
Reports found 86% of consumers want
meats raised without antibiotics available
in their local grocery stores, and more than
60% of those asked said they’d be willing
to pay at least five cents more per pound to
purchase drug-free meats.
The poll, released by Consumers
Union on Tuesday and available at
www.ConsumerReports.org, notes that
a majority of respondents (72%) were
“extremely or very concerned about
the overuse of antibiotics in animal
feed, including the potential to create
‘superbugs’.”
Investigators from Consumer
Reports visited 136 supermarkets in
23 states, including at least five stores
belonging to the 13 largest supermarket
chains and collected data on more than
1,100 different antibiotic-free meat and
poultry items.
At the same time, Consumers Union,
the public policy arm of Consumer
Reports, announced it is asking Trader
Joe’s stores to sell meat and poultry
products that have been raised without
antibiotics, and is asking USDA to tighten
its labeling standards for meats raised
without antibiotics.
Call 888-732-7070, Option 2, write agra.enquiries@informa.com or visit www.foodchemicalnews.com
© Informa Ltd 2012
June 22, 2012
Additives
Gruma, March of Dimes among groups seeking
approval for folic acid in corn masa flour
By Amber Healy
I
t’s an oversight that FDA has
required the addition of folic acid in
enriched flours, breads and cereals
since 1999, but has not yet approved
its addition to corn masa flour, say four
health care groups and two companies
that have petitioned the agency to rectify
the oversight. That leaves the Hispanic
population at risk for birth defects, such as
spina bifida and anencephaly,
The March of Dimes Foundation, Spina
Bifida Association, American Academy of
Pediatrics, National Council of La Raza,
Gruma Corporation and Royal DSM, N.V.,
asked the FDA in April to approve the use
of folic acid in corn masa flour. The petition,
which was published in the Federal Register
on June 13, requires a change in the food
additive regulations for folic acid, also
known as vitamin B9, as established in 21
CFR 172.345 (see www.gpo.gov/fdsys/pkg/
FR-2012-06-13/pdf/2012-14263.pdf).
Typically, FDA must respond to
petitions within 90 working days from
the time the agency accepts it for
consideration, which was at some time
in May, an FDA spokesperson tells Food
Chemical News.
Using folic acid to enrich flour and
grain-based products has been attributed
with a rapid decrease in the rates of some
birth defects, recounts Elizabeth Lynch,
a spokesperson for the March of Dimes
Foundation. The only area where that
same decline has not been observed is
within the U.S. Hispanic population,
where foods, like tortillas, made with corn
masa flour are a dietary staple.
“A large number of U.S. consumers
also regularly use products made
from corn masa flour; and, in certain
populations of Latin American descent,
corn masa flour products replace many
wheat flour products in the diet, leaving
many of these consumers effectively
beyond the reach of the current cereal
fortification programs, and potentially
below recommended intakes for folic
acid,” the groups say in an introductory
letter submitted with the April petition.
Pregnant women and women of
childbearing age are encouraged to
consume at least 400 micrograms of
folic acid daily, Lynch says. Research
conducted over the past few decades
strongly indicates that folic acid intake at
this level can reduce by 50% the risk of
neural tube defects, including spina bifida,
a condition in which a fetus’ backbone
and spinal cord do not close before birth,
and anencephaly, in which babies are born
without portions of their brain or skull.
As a result of folic acid enrichment
currently not being approved for corn masa
flour, Hispanic women have a 20% greater
risk of having a child with one of these
neural tube defects, the groups say in an
April 18 statement announcing the petition.
Gruma Corporation, a Monterey,
Mexico-based company that reports to be
the largest tortilla and corn manufacturing
company in the world, has been working on
ways to enrich its Mission product line of
tortillas and other corn flour products with
folic acid if FDA approves the petition.
“We strive to produce products that
support the health of consumers,” Joel
Suarez, Gruma’s chief executive officer says.
“If fortification of corn masa flour
can be achieved, lives will be saved and
families spared a lifetime of struggling to
ensure the complicated health and social
needs of their loved ones are met,” says
Cindy Brownstein, president and CEO
of the Spina Bifida Association in the
statement.
Janet Murguia, president and CEO
of the National Council of La Raza, an
Hispanic civil rights advocacy group, calls
on FDA to approve the petition in order
to “specifically address the substantially
higher rates of birth defects that our
community faces. We are glad to see so
many groups committed to the health and
safety of Latino children and hope FDA
thoughtfully considers this incredibly
important petition.”
Trade group says EU additive approvals system is working
T
he EU’s new legal framework
for food additives passes the
“efficiency test,” according to
the Federation of European Specialty
Ingredients (ELC), which spoke out after
three regulations extending approved uses
of food additives were published in the
June 5 issue of the EU’s Official Journal.
The regulations, which provide for
the extension of uses of three permitted
food additives in additional applications,
are scheduled to come into force on June
25. The three regulations deal with the
extension of uses of polydextrose, as a
stabilizer, and lysozyme, as a preservative,
both in beer as well as glycerol esters of
wood rosins (a solid form of resins) as
© Informa Ltd 2012
an emulsifier for printing on hard-coated
confectionery products, EU Food Law
reports.
The additives, which already were
authorized on the European market for
certain food applications, were approved
in line with the EU’s new legislative
framework applicable to food ingredients
including additives, the so-called Food
Improvement Agent Package.
“The smooth adoption of these three
texts illustrates the efficient functioning of
the Food Improvement Agents Package,
adopted in 2008,” the ELC says in a
statement issued on June 6.
“As the smooth approval of these
three regulations exemplifies, this
legislative package provides for regulatory
mechanisms (e.g., adoption through the
regulatory procedure with scrutiny and use
of regulations instead of directives) that
speed up and streamline the procedures for
the extension of uses of already permitted
additives and for the authorization of new
additives too, as it has been the case for
steviol glycosides,” ELC continues.
The organization also points out that
the framework can be used to adopt further
restrictions of uses pointing to the recently
agreed conditions of use and use levels for
aluminum-containing food additives as an
example (see FCN June 1, 2012, Page 15).
Approvals system ► 6
5
June 22, 2012
Additives
Approvals system ◄ 5
“The ELC is pleased that the Food
Improvement Agents Package, which
resulted from a continued dialogue
between the European Commission and
the stakeholders, proves to be a robust
and efficient legislative framework,” the
statement says.
“The ELC appreciates in particular
that extensions of uses and authorizations
of new food additives are now submitted
on a case-by-case basis rather than in
the framework of a combined directive.
This not only brings more coherence
but also legal certainty to the food
additives sector,” it adds. “Overall, these
streamlined legal instruments guarantee
the effective functioning of a market that
is key to the whole food chain and, thus,
benefit the European consumers.”
Biotechnology
BIO and ASTA draft agreement to deal
with patent expiration issues
By Stephen Clapp
W
hat happens when patents on
Roundup Ready soybeans
and other popular genetically
engineered traits expire in less than three
years’ time? How will biotech companies,
farmers and U.S. trading partners deal with
traits whose patents have expired?
The Biotechnology Industry Organization
(BIO) and the American Seed Trade
Association (ASTA) are meeting separately
this week and next to draft a Genetic Event
Marketability and Access Agreement
(GEMAA) aimed at answering those thorny
questions.
The 2012 BIO Annual Convention
kicked off Monday at the cavernous
Boston Convention Center, drawing more
than 16,000 registrants, according to the
organizers. In an interview on the sidelines
of the event, Cathy Enright, executive vice
president for food and agriculture, told
Food Chemical News that the GEMAA,
which she describes as a binding contract of
manageable length, is the organization’s top
priority in the coming months.
“Completion of the post-patent accord
will enable a transition to the generic
marketplace,” she said.
“Once we have the completed text, we’ll
reach out to stakeholders for comment. Any
potential signatory [of the accord] would
want to do an internal legal review. The
Department of Justice has also done a review
and will want to weigh in.”
Once the process is complete, the
GEMAA can be signed by individual
biotech companies, grower group
associations, universities and other
institutions interested in the expired patents.
“Signatories have obligations as well
6
as benefits,” Enright noted, referring to
stewardship duties.
“If you are a signatory, you’ll get three
years notice from a company before their
patent expires,” she reported. “You’ll know
what a company intends to do with the
expired patent. Will it stay on the market?
Will it transition to other biotech developers?”
Enright said the GEMAA accord will
provide access to information on expired
traits, international regulatory approvals
and data sharing and use. “Signatories can
enter dialogue with folks who want access
to an event for their own use. There’s great
alignment in the biotech community to have
this situation simplified.”
In parallel with the GEMAA accord, BIO
is drafting a Data Use and Compensation
Agreement (DUCA) that provides a
structured mechanism for sharing of data.
“Our goal is to do it right and yet to be
efficient,” Enright said. “We want to do both
agreements as soon as possible.”
Reaction from biotech companies
and farmers
About 200 people attended a 75-minute
session Tuesday morning on the patent
expiration issue, hearing a biotech company
executive and a soybean farmer react to
a presentation on the two agreements
by Matthew O’Mara, BIO’s director of
international affairs.
Ray Goaesser, vice president of the
American Soybean Association, commented,
“We want an industry-led seamless transition
that’s legally binding and protects our export
markets by maintaining our registrations
there. We need a seamless transition from
patented seeds to generics that involves both
simple and stacked traits. We’re running up
to patent expiration in one or two years.
“Most patent-expiring events will be
used in stacks, not as single events. We need
certainty for the complete value chain. We
need a clear pathway for the transition of
events. We need to protect innovation while
promoting access and innovation. Who will
take the post-patent products to the market?”
Cassie Edgar, a one-time patent lawyer
who is now a DuPont Pioneer executive,
agreed that the biotech future is about
stacked products, yet there is no harmonized
global regulatory system to deal with them.
“We’ll need approvals in multiple countries,
not just North America but also the EU and
Asia,” Edgar said. “Every country has a
different regulatory approach, and changes
can be made on a daily or weekly basis.
How will the global food system handle
these multiple traits and expired patents?”
During the discussion period,
moderator Thomas Redick, an
attorney with St. Louis-based Global
Environmental Ethics Counsel, stressed
the international aspect of the patent
expiration problem. “Is there a way to
educate folks about expirations and
approvals?” he asked.
BIO’s O’Mara replied, “Transparency
is helpful, but a database would be
complicated.”
DuPont’s Edgar added, “You might
have event patents, stacked patents,
date changes for patent expiration. It’s
extremely complicated -- there’s no one
way. There are lots of licensing agreements.”
Later, she said, “Companies need data
protection to protect their investment. Global
GRAS [generally recognized as safe] would
be great!”
Roger Beachy, president of the Donald
ASTA ► 7
© Informa Ltd 2012
June 22, 2012
Biotechnology
ASTA◄ 6
Danforth Plant Science Center, asked about
the likelihood that the enabling DNA would
be off patent.
“Once DNA is off patent, there would be
a separate regulatory package,” replied Edgar.
“Things are moving backward. Regulators
want to see everything all over again.”
“Monsanto is going to move
beyond Roundup Ready One once the
patent expires,” suggested Greg Jaffe,
biotechnology program director at the Center
for Science in the Public Interest. “Is that the
future of these biotech crops? Will only a
generic be available?”
“It depends on the company and their
strategy,” said Edgar. “A lot of the outcome
depends on how the [GEMAA] accord
comes together. We’ll see how things unfold
in the next year.”
Political obstacles to biotech food a recurring
theme at BIO convention in Boston
By Stephen Clapp
W
hile celebrating their recent
innovations that’ve led to
greater crop yields and
making plans for more breakthroughs in
overcoming droughts or pests, some of
the roughly 16,000 in attendance at the
Biotechnology Industry Organization’s
annual convention, in Boston, this week,
also vented about the growing number of
obstacles that confront them.
At a Tuesday morning session on
“Public Health and GE Crops,” Bruce
Ferguson, chairman of Edenspace, a
biotech company based in Manhattan,
Kan., warned that passage in November of
the California ballot initiative to require
labeling of biotech food products would
affect food companies nationwide and
overseas, for example (see FCN June 15,
2012, Page 9).
Noting that biotech labeling for
California alone would be troublesome and
expensive, he portrayed a scenario in which
food companies would label every eligible
product nationwide as well as exports to the
European Union and elsewhere.
“Possibly, food companies would turn
to conventional crops for ingredients
to avoid having to label. In any case, it
results in a mess. It would result in higher
costs for companies and consumers,”
he added. “Labeling foods developed
with crop biotech is misleading and
counterproductive. Regulation should
reflect scientific assessments of public
health dangers. Food worries are often
misdirected.”
Ferguson speculated that FDA might
conclude that federal law preempts the
proposed California law and file a lawsuit
if it passes. However, another industry
source, who asked not to be identified,
© Informa Ltd 2012
tells Food Chemical News that the agency
thus far declines to discuss that possibility.
In fact, the Obama administration has
shown little courage when it comes to
biotechnology, said Ron Stotish, CEO
of Waltham, Mass.-based AquaBounty
Technologies, during a breakout session
Tuesday afternoon. His company
developed the transgenic AquAdvantage
salmon, the application for which has been
awaiting action by FDA since back-toback public meetings in September 2010
(see FCN Sept. 27, 2010, Page 5).
“There is no leadership in this [Obama]
administration on this GE salmon issue,
which leads to mischief in Congress, the
press and the public sector,” Stotish said.
“We’re the unwilling poster child for
transgenic animals. We had hoped that
FDA’s use of animal drug regulation would
provide trust to the public. The Center
for Veterinary Medicine has the scientists
and the tools to evaluate our application.
However, there’s a well-financed and
aggressive anti-technology lobby out there.
Food & Water Watch continues to promote
the urban legend that our fish would contain
higher levels of PCBs.”
Coexistence used as weapon by
organic industry
Meanwhile, a separate effort by
Agriculture Secretary Tom Vilsack to
promote coexistence between biotech and
conventional farmers is actually giving
some in the organic industry yet another
weapon to use against the biotech industry,
suggested Greg Conko, senior fellow at
the Washington, D.C.-based Competitive
Enterprise Institute, while moderating a
session on the topic Wednesday morning.
Conko described coexistence as “the
issue of most importance to the future
of biotech” and said “there’s no reason
to think that biotech and organic can’t
exist together practically before adding:
“Unfortunately, there are those in the
organic and environment community who
see coexistence as a way to drive biotech
out of business. Activists are rejecting
common-sense practices and would
place all their economic burdens on their
neighbors.”
USDA in 2010 wrestled with how to
regulate Roundup Ready alfalfa without
harming non-biotech alfalfa. Allen Van
Deynze, an agronomist at the University of
California-Davis, said a proposal to restrict
RR alfalfa seed cultivation in California
on a county-by-county basis would have
affected 45% of growers and 57% of land
in the state. “Our counties are bigger than
the state of Massachusetts,” he noted.
Now that USDA has granted full
deregulation of RR alfalfa, Van Deynze
reported that alfalfa growers have
now voluntarily formed temporary
“opportunity zones” for non-GE seeds.
“These are market decisions that don’t
need regulation.” However, Van Deynze
predicted disaster “if we become a
litigation-based industry. Establishing
strict liability for gene flow would result in
a legal free-for-all.”
In the European Union, opponents have
become masterful at using the European
Commission’s 2010 coexistence regulation
to beat back the biotech industry, reported
Daniel Pearsall, secretary of the UK’s
Supply Chain Initiative on Modified
Agricultural Crops, during the same
session. It allows member-states to
individually decide their own policies on
allowing biotech crop cultivation.
The EU is a “parallel universe” where
biotech is concerned, and coexistence
Boston convention ► 8
7
June 22, 2012
Biotechnology
Boston convention◄ 7
in the EU is “an additional barrier to
our constipated regulatory system,” he
proclaimed. “Member-states can do
what they want; there are no scientific or
technical requirements needed.”
However, Pearsall added that
coexistence is “thriving within the supply
chain” in the UK and elsewhere where
market forces are allowed to prevail. Also,
he forecast that the EU regulation will
be challenged in court as a violation of
internal market rules.
Developing countries getting
skittish, too
While the U.S. and EU have battled
resistance to biotechnology for several
years, developing countries have been
cautiously eager to embrace it. That’s
not the case anymore, reported Robert
Paarlberg, a political scientist at Wellesley
College. There’s been “something of a
stall” in commercializing biotech crops
in Africa and Asia, he said during another
session at the conference.
“Two or three years ago there was a
more positive mood, in response to the
food price crisis in 2008,” Paarlberg
recalled. “We thought China would go
ahead with GE rice and India would go
ahead with GE eggplant. We thought
Kenya and the rest of Africa would go
ahead with some crops.
“What’s going on here? The
conventional explanation is lack of
technical capacity to regulate. But that’s
not the case. China got full technical
approval. Commercialization has been
slowed down by politics. India got full
approval for Bt eggplant but was blocked
by the environment minister. In Africa,
Kenya passed a biosafety bill and new
national regulations” but nothing more has
happened, he noted.
“What’s holding these approvals back?
These countries can screen for health
and safety. It’s political and commercial
risks, especially to exports,” Paarlberg
concluded.
Dennis Kyetere, executive director
of the African Agricultural Technology
Foundation, offered “some encouraging
news,” citing several countries that have
recently adopted biosafety regulations. “Yes,
there are challenges, but there’s lots going
on. The speed of commercialization could be
higher. Debates in Europe do affect Africa.”
Judy Chambers, director of the
biosafety systems program at the
Washington, D.C.-based International
Food Policy Research Institute (IFPRI),
complained that the Cartagena Biosafety
Protocol, an international agreement
to regulate biodiversity, is stymying
biotech adoption in developing countries.
She called it an “onerous and archaic
regulatory system that has confused the
regulatory system in many countries.
It’s a huge disservice to the cause of
biodiversity.”
Chambers noted that the next meeting
of parties to the Cartagena Protocol will
take place in India and discuss the role of
socioeconomic considerations, which has
the potential for “lots of mischief.”
Chambers also blasted a biosafety
model law developed by the African Union
as containing “many onerous provisions.
Countries fall back on the model law
as a platform for their own regulations,
responding to a promise, “You will be
risk-free,” she reported.
In concluding remarks, Chambers
highlighted “great market potential in
these countries. Companies in China, India
and Brazil are adapting to conditions in
Africa. Look at Africa as a continent that
can help feed the world.”
EU biotech cultivation proposals appear dead in the water
I
t’s “not possible” to achieve an
agreement on proposals to allow
national bans on the cultivation of
EU-approved biotech crops, the Danish
Presidency of the European Union
concluded following a meeting of EU
environment ministers earlier this month,
EU Food Law reports.
The proposals are not currently on the
work program of Cyprus, which takes
over the rotating six-month EU Presidency
next month, says Danish Environment
Minister Ida Auken. Her comments, made
after a June 11 meeting, raise a question over
the future of the proposals, which memberstates have been debating since 2010.
Auken previously warned that she
wouldn’t present the proposals for a vote
at the meeting if there were signs of a
repeat of the stalemate reached in March
(see FCN March 16, 2012, Page 7).
Instead of a vote, the meeting merely took
note of a progress report from the Danish
presidency.
8
Auken notes that Denmark did “almost
everything” to dissolve the last part of a
blocking minority of member-states. Some
nine countries, including Cyprus, Ireland,
Slovakia, Slovenia and Spain, expressed
reservations in March. Objectors have
since shrunk to a core group of Belgium,
France, Germany and the UK, but they
refuse to change their stance.
Among the key problems for the
four countries is potential conflict with
EU and WTO rules on free trade. They
argue that national authorities will face
legal challenges if they block the use of
any product that has been assessed and
approved according to EU law.
The countries aren’t convinced that
bans could be justified using the suggested
criteria, which include local agricultural,
environmental and socioeconomic
conditions. Another issue, particularly
for France, is that improvements to EU
biotech legislation, as initiated by EU
environment ministers in 2008, should
be fully implemented before any further
changes are made.
Auken maintains that the Danish
compromise proposal, originally presented
in March, was the “best” text in terms of
trying to meet all positions. The compromise
had suggested that countries strike deals
with applicant companies to exclude their
territory from commercialization plans.
However, she believes that “it is not textual
amendments that can change things, only
political realities.”
The proposals were originally drawn up
by the European Commission, at the request
of 13 member-states, in an effort to stop
delays in EU biotech approvals. It remains to
be seen what will now happen to registration
times. Several applications for cultivation
have been stalled in the EU system for
many years. With regard to applications for
imports, approvals have been delayed in
every case, because member-states cannot
reach the qualified majority vote required to
accept or reject them.
© Informa Ltd 2012
June 22, 2012
Biotechnology
European Commission investigates
rice imports from India
T
he European Commission is
investigating evidence of illegal
transgenic material in rice imports
from India, according to a report issued June 7
by the nonprofit group GMWatch (www.
gmwatch.org/latest-listing/1news-items/
13963-india-denies-gmo-contamination-inbasmati).
The commission’s Directorate-General
for Health and Consumers (DG SANCO)
has sought clarification from India on
unknown and unauthorized transgenes
found in its rice exports. The notification
was issued following a complaint by
French manufacturer, Soufflet Alimentaire,
to the EU’s Rapid Alert System of Food
and Feed. Soufflet Alimentaire packs
basmati rice for retail sale.
India has denied the contamination
allegations, asserting that it grows no
biotech food crops.
Paolo Testori Coggi, DG SANCO
director general, had requested several
reassurances from the Indian government,
including: (1) information about its
official policy on the cultivation of
GMOs for food and feed use; (2) a
list of GMOs currently authorized for
cultivation in India and official controls
in place; (3) a history of Indian field trials;
(4) controls in place on the presence of
GMOs in rice exported to the EU; (5)
details of primary basmati growing
regions; and (6) the source of seed
cultivation of basmati rice in India and
biotech tests.
Marketing of the product by Soufflet
Alimentaire has been suspended until
further investigation.
The EU investigation is a potential blow
to the Indian government, which is seeking
to ramp up the nation’s rice exports.
Biotech Briefs
Mexico has approved the commercial
release of Monsanto’s Roundup Ready
soybeans for planting on 253,000
hectares, Agrow reports. The agriculture
ministry’s authorization came earlier this
year and covers seven states. The approval
is the first for biotech soybeans. Only field
trials and intermediate, pre-commercial
stage pilot plantings had previously been
undertaken. USDA’s Foreign Agricultural
Service notes that the approval comes “at
a politically sensitive time,” with rising
resistance to biotechnology in Mexico and
imminent elections for a new government.
The Brussels-based trade association
EuropaBio says in a June 1 position paper
that the number of biotech crop varieties
in the European Union’s backlog has
reached an “all time record.” A total of 73
products are now in the registration system,
of which 57 are awaiting a European Food
Safety Authority’s opinion on the safety
assessment and 16 are awaiting further
action from the European Commission
or member-states. EuropaBio notes that
procedural deadlines are regularly exceeded
and that some applications were submitted
as long ago as 2004. The oldest applications
are for cultivation of Dow AgroSciences
1507 (Herculex I) corn and Syngenta’s Bt11
corn.
Syngenta plans to carry out a $63
million expansion of its corn seed
production facility in Phillips, Neb., the
© Informa Ltd 2012
company says in a May 29 news release. It
includes the purchase of 42 acres of land
and contracting production on a further
5,500 acres. Construction of new storage
and conditioning facilities is due to start
this month, with completion expected in
time for the 2013 harvest.
Three-quarters of Canadian farmers
say that herbicide-resistant weeds are
affecting their profits, according to
a survey by Ipsos Reid conducted on
behalf of BASF, our sister publication
Agrow reports. Of the 500 farmers
questioned, 7% considered the impact
to be “large,” 20% “moderate” and 47%
“small.” The majority (56%) agreed that
weeds were getting “tougher to control,”
while 43% disagreed. Almost all (96%)
said that they used products from more
than one herbicide group to manage their
weeds.
Japan’s Hokko Chemical company and
the Indian seed company Krishidhan
Seeds (Jalna) have signed an exclusive
agreement to develop insect-resistant
and herbicide-tolerant traits in major
crops, Agrow reports. Krishidhan receives
exclusive rights from Hokko to develop
and sell crops containing a glufosinate
herbicide tolerance gene developed by the
Japanese company. The Indian company
plans to stack the in-licensed trait with
its own indigenous insect resistance and
other herbicide tolerance genes to develop
biotic stress-tolerant crops, including corn,
soybeans, rice, wheat, eggplants, chili,
onions and tomatoes.
Dow AgroSciences is launching its
five-stack genetically modified insectresistant and herbicide-tolerant
PowerCore corn in Brazil for the
October planting season, Agrow reports.
The product incorporates the Herculex
1 (TC1507) and YieldGard VT Pro
(MON89034) above-ground pest control
traits. It became the first five-stack biotech
crop to be authorized for sale in Brazil
last year. Dow also expects commercial
approval for the product “in the very
near future” in Argentina. “We anticipate
sales to begin in the fourth quarter,” the
company told Agrow.
The Australian Office of the
Gene Technology Regulator
(OGTR) has approved an application
from Pioneer Hi-Bred International
to conduct field tests on biotech
glyphosate-tolerant canola, Agrow
reports. The canola expresses the gat4621
gene from the bacterium, Bacillus
licheniformis. The company plans to
test the crop between this month and
February 2016 over a combined area of
512 hectares on as many as 68 sites.
In February, the OGTR concluded
that the proposed tests posed negligible
risks to human health or the
environment.
9
June 22, 2012
Codex
zilpaterol show no signs of yielding
By Stephen Clapp
R
actopamine will be one of two
veterinary drugs of focus for the
U.S. delegation when it heads to
Rome, next month, to attend the annual
Codex Alimentarius Commission meeting.
And the other drug might run into even
more resistance.
In addition to winning adoption
of maximum residue limits (MRLs)
for ractopamine, a feed additive used
to promote muscle development in
food animals, the U.S. delegation
hopes to add zilpaterol to the priority
list of veterinary drugs for evaluation by
the Joint FAO/WHO Expert Committee
on Food Additives (JECFA) (see
FCN June 8, 2012, Page 8). Produced
by Intervet, a subsidiary of Merck
pharmaceuticals, zilpaterol hydrochloride
(trade name Zilmak) is used to increase
the size of cattle and improve feed
efficiency.
However, Michael Hansen, a senior
scientist at Consumers Union who
regularly represents the umbrella
organization Consumers International
at Codex meetings, sees no willingness
on his side to advance either growth
promoting drug. He notes that
ractopamine proponents received an
unexpected setback last year when the
Codex Commission, by secret ballot
on a procedural motion, declined,
68-59, to agree to vote on adoption of the
MRLs.
“People were stunned by the vote,”
Hansen tells Food Chemical News.
“Our side had made proposals for
further negotiation [prior to the vote],
but their side was certain they had the
votes.”
Hansen sees no gestures toward
compromise by the United States and
its allies this year. He reports that
there were no sideline negotiations on
ractopamine when the Codex Committee
on General Principles, in April,
discussed the problem of standards held
indefinitely at Step 8 in the eight-step
Codex approval process (see FCN April 6,
2012, Page 9).
10
“Yes, ractopamine is on [next month’s
agenda], but there’s been no movement,”
Hansen reports. “The unanswered safety
questions are still there. Africa is no
longer on the U.S. side. In fact, the Ghana
[delegate] caucused with our side. Will the
U.S. try to force a vote again?”
Zilpaterol is even worse than
ractopamine, Hansen says. He cites an
April 15 article in the Chronicle of
Higher Education, in which Glen
Dolezal, a Cargill executive, is quoted as
saying that his company won’t buy cattle
that it knows have been fed zilpaterol,
because an overly aggressive focus
on growth “can have an impact on the
consumer attributes of size, quality, and
tenderness. So we need to find a balance.
The message there is that we ask you to
“We weren’t happy with
the time and resources the
veterinary drugs took last
year. We hope there’s better
management of the issues
this year”
– Peggy Rochette, outgoing
senior director of international
affairs at the Grocery
Manufacturers Association.
be careful.”
Hansen says Codex needs a larger
discussion of growth promotants in
general. “A country needs to be able
to say, ‘We don’t want to use growth
promotants,’” he says.
Ron Phillips, a spokesperson for the
Washington, D.C.-based Animal Health
Institute, tells FCN that AHI won’t be
attending the Codex Commission meeting,
but its views will be represented by the
Brussels-based International Federation
for Animal Health and by Elanco and
Merck, manufacturers of the drugs at
issue.
Rochette hopes for better
management
Peggy Rochette, outgoing senior
director of international affairs at the
Grocery Manufacturers Association, will
be making her final appearance at a Codex
Commission meeting next month as
representative of the International
Council of Grocery Manufacturers
Associations (ICGMA). She
acknowledges that GMA members
have no direct interest in the veterinary
drug issues, but she is concerned about
upholding Codex’s scientific processes
and procedures in the debates over
ractopamine and zilpaterol.
“We weren’t happy with the time and
resources the veterinary drugs took last
year,” she tells FCN. “We hope there’s
better management of the issues this year.
We don’t like to see one issue take over
the whole discussion.”
“From GMA’s point of view, we don’t
see a lot of controversial issues for our
members coming forward,” she continues.
“There are some old issues and some
new ones. We don’t see any opposition to
mandatory nutrition labeling, but it’s
a new issue for discussion by the
developing world.”
ICGMA favors advancement of
food additive standards proposed by
the Committee on Food Additives and
principles for national food control
systems proposed by the Committee
on Import and Export Inspection and
Certification Systems. The umbrella
group also favors principles for testing
in trade advanced by the Committee on
Methods of Analysis and Sampling. “The
text isn’t completed, but the principles are
advanced,” she notes.
Rochette says ICGMA will strongly
oppose any attempt to reopen work on
a processed cheese standard, which
was rejected by the Committee on Milk
and Milk Products before it went out of
business in 2010.
ICGMA is as interested in new
work proposals as it is in finished
standards ready for adoption, Rochette
points out. “There’s lots of new work
[proposals] on contaminants in food
-- six new items,” she says, concluding:
“Overall, it looks to us like a simple,
straightforward agenda, except for
veterinary drugs.”
© Informa Ltd 2012
June 22, 2012
FDA
FDA backs off dietary supplement guidance
By Joan Murphy
A
fter nearly a year of protests from
the dietary supplement industry,
FDA is backing away from sticking
points in its New Dietary Ingredient (NDI)
Notification draft guidance and plans to
issue a revised guidance.
FDA Commissioner Margaret Hamburg
and Deputy Commissioner for Foods Mike
Taylor announced the policy move in a
meeting with Sens. Orrin Hatch (R-Utah)
and Tom Harkin (D-Iowa), the Council of
Responsible Nutrition reported Wednesday.
The change in heart is confirmed in a letter
sent Tuesday to the dietary supplement
industry by Daniel Fabricant, the director
of FDA’s Division of Dietary Supplement
Programs.
“We are grateful to FDA for its willingness
to have an open and ongoing dialogue with
our industry,” Steve Mister, CRN president
and CEO, says in reaction to the news.
“We understand the complexities
involved for FDA in developing practical
and workable regulation, and we remain
willing to work cooperatively to help
ensure the guidance will be manageable
for industry and enforceable for FDA, and
will ultimately benefit consumers.”
The draft guidance became public enemy
#1 for the supplement industry when it was
issued last July (see FCN July 15, 2011,
Page 12).
The industry had eagerly awaited
the document (www.fda.gov/food/
guidancecomplianceregulatoryinformation/
guidancedocuments/dietarysupplements/
ucm257563.htm) in hopes that it would
establish a clear framework for deciding
when a premarket safety notification for a
supplement containing an NDI is necessary.
FSMA ◄ 1
enforcement clarifies expectations and
allows industry to focus on the critical
task at hand of strengthening America’s
food safety net.” GMA says its looks
forward to the release of the proposed
rules and is “moving forward with the
full speed and strength of the industry to
further bolster our food safety systems as
© Informa Ltd 2012
The Dietary Supplement Health and Education
Act of 1994 requires a manufacturer or
a distributor of an NDI to notify FDA
at least 75 days before introducing a
supplement on the market unless the NDI
had been present in the food supply in
a form “in which the food has not been
chemically altered.”
The draft document set up procedures
for submitting an NDI notification,
the types of data and information that
FDA recommends manufacturers and
distributors consider when they evaluate
the safety of a dietary supplement
containing an NDI, and what should be
included in an NDI notification.
But the industry suffered buyers’ remorse
after it discovered the large amount of safety
data FDA wanted the industry to collect to
prove new ingredients were safe.
Earlier this week, the House
Appropriations Committee approved
a spending bill for fiscal 2013 that
recommended the FDA "re-engage the
dietary supplement community to develop
a new guidance on what constitutes NDI”
(see related story, Page 12). FDA already
is using the draft guidance for enforcement
activities against manufacturers although
it is still in draft form, the committee
report says.
CRN says FDA plans to revisit the
following five “problematic” areas the
industry identified with the NDI draft:
• Industry responsibility for proving
grandfathered status of particular
ingredients;
• The permissibility of using synthetic
versions of botanical components in
supplements;
• The definition of the term ‘chemically
altered’;
• N
DI submissions for an ingredient versus
finished products; and
• The level of data necessary to
demonstrate the safety of NDIs.
prescribed in FSMA.”
While the news may be welcomed by
the food industry, a consumer advocate
expressed frustration that FDA would not
start enforcing the law next month.
“It is clearly distressing that FDA is
choosing not to enforce the Food Safety
Modernization Act as it was written,”
says Caroline Smith DeWaal, food safety
director at the Center for Science in the
Public Interest. “Congress was clear
that they expected companies to come
into compliance next month with the
requirements to have comprehensive food
safety plans, but FDA seems to be giving
them a pass,” she says.
“If an outbreak occurs, the
consequences of FDA’s nonfeasance could
be tragic and could reflect badly on the
president,” she warns.
Plans for meeting with industry
CRN says FDA has not committed to
a timeline for its new draft guidance but
agency officials indicated their desire to
move quickly. Fabricant indicates, in his
letter sent Tuesday, that issues may be
further hammered out in a future meeting.
“One item that you may hear from
their personal and/or committee staffs in
the near future and I wanted to confirm
is that we are planning on promulgating
a revised draft NDI guidance to address
points that may need further clarity to avoid
misinterpretation, and possibly being taken
out of statutory context,” he says in his letter.
“While we are working diligently on the
matter, the timeline is unknown at present,
yet, we will keep all parties posted on
progress to the extent we can. Please assure
your members that the comments received
in December are still being administratively
reviewed and vetted accordingly. We will
likely be in contact in the near future on the
issue, maybe for a possible meeting,” he says.
Mister says CRN will continue to
help educate the industry on the statutory
requirements for NDI notification while the
dialogue continues on the draft guidance.
“CRN looks forward to the continued
support from FDA, particularly
Dr. Daniel Fabricant, whose willingness
to participate in industry conferences,
webinars and other educational efforts has
been so important for keeping the lines
of communication open and helping the
industry understand FDA’s expectations
for NDI submissions,” Mister says.
11
June 22, 2012
Interagency
House committee rejects $50 million more for
FDA food safety, won’t spare MDP
By Joan Murphy
T
he House Appropriations
Committee rejected an amendment
offered by Rep. Rosa DeLauro
(D-Conn.) Tuesday that would have
boosted FDA’s food program by
another $50 million and allowed the
administration to continue the system for
collecting foodborne pathogen data that
is threatened by the proposed elimination
of the USDA’s Microbiological Data
Program (MDP).
The $19.4 billion FDA-USDA spending
bill, which was approved by a voice vote
Tuesday, represents a $365 million cut
below last year’s level and $1.7 billion
below the president’s request. Within the
bill, the panel approved $2.481 billion for
FDA’s budget next year, of which $10.8
million in new money would go towards
funding the food program.
“This legislation represents a careful
balance between fiscal restraint and
responsible investments in programs to
support an abundant and safe food and
drug supply, promote U.S. interests in the
global economy, and encourage economic
development in our rural communities,”
said House Appropriations Chairman Hal
Rogers (R-Ky.) after the vote.
Not satisfied with the proposed
increase, DeLauro offered an amendment
that would have funded FDA’s Center
for Food Safety and Applied Nutrition
and related activities at the Office of
Regulatory Affairs at $933.5 million,
a boost from the $883.5 million the
subcommittee agreed to at a June 6
markup (see FCN June 8, 2012, Page 12).
It was rejected by voice vote, however.
“A single preventable death is one too
many,” DeLauro says in a press statement
issued after the vote. “Whether it is Listeria
in cantaloupes or E. coli in Germany,
outbreaks of foodborne illnesses have
become frighteningly normal. Protecting
our food supply is not just a health issue; it
is a security and moral issue as well.”
Despite the setback, Delauro pledged
to continue pushing for more food safety
funds on the House floor. “As this bill
12
moves through Congress, I will continue
to press for this critical funding that it is
our responsibility to provide,” she said.
No “budgetary dust” for MDP
DeLauro’s amendment also would have
inserted the following report language:
“The administration shall continue to
collect the foodborne pathogen monitoring
data that has been collected by the
Microbiological Data Program since 2001
through cooperation with state agriculture
departments and other federal agencies.”
When USDA revealed, in its budget
proposal released in February, that it
was opting to eliminate the $4.4 million
program, DeLauro decried the decision,
calling the amount needed to sustain
MDP “budgetary dust” and urging the
committee and the department to retain
the program (see FCN Feb. 24, 2012, Page
12). The national foodborne pathogen
monitoring effort directs states to collect
samples of pathogens on produce, but the
once-research program has resulted in
recalls that has irked the produce industry.
The spending bill also doles out a
small cut for USDA’s Food Safety and
Inspection Service, which would receive
an $8.9 million cut from its current
spending level of $1 billion.
But the bill still has to be approved on
the House floor, and the companion Senate
measure, which was passed April 26 in
the Senate Appropriations Committee,
has yet to be scheduled for floor debate.
At this point, the path for these spending
bills is unclear as Congress is butting up
against a presidential election and must
maneuver around the looming January
2013 mandated across-the-board cuts.
In a statement issued Tuesday, the
Alliance for a Stronger FDA gave a nod to
appropriators for funding some programs, but
noted the proposed legislation would reduce
FDA spending overall by about $16 million
below its FY12 funding level of $2.497
billion for salaries and expenses, as well as
not fund building and facilities repair.
“While the bottomline funding for
FDA is less than needed, we concur with
the committee’s decision to fund the
commissioner’s initiatives to advance food
safety and to improve the safety of imports
from China,” says Margaret Anderson, president
of the Alliance and executive director of
FasterCures, an organization that works to
speed the time it takes to get important new
medicines from discovery to patients.
Potatoes back in WIC;
horse inspections out
The committee Tuesday approved
other amendments that touch on food
programs. The bill now would allow white
potatoes to be eligible for purchase as
part of the Women, Infants and Children
nutrition program food packages, thanks
to an amendment offered by Rep. Mike
Simpson (R-Idaho).
Food safety ► 13
BREAKING NEWS! White House threatens to veto appropriations bill
As Food Chemical News went to press, the White House issued a statement
Thursday threatening to veto the agriculture spending bill for a list of reasons,
including a lack of sufficient funds for implementation of the FDA Food Safety
Modernization Act and a cut to grants under USDA’s Agriculture and Food Research
Initiative. “The Administration strongly supports robust funding for FDA to
continue implementation of the Food Safety Modernization Act, improve oversight
of imports, and invest in the development of medical products, including medical
countermeasures,” the White House says. The administration is urging the House
of Representatives to adopt the new user fees it proposed for the FY ’13 budget.
Proposed food facility registration fees are expected to raise $220 million. For the
latest details, check out our daily articles in the online version of Food Chemical
News (www.foodchemicalnews.com).
© Informa Ltd 2012
June 22, 2012
Interagency
Food safety ◄ 12
Committee wants HIMP by Oct. 1
Before the committee voted on the bill,
it released an 89-page report that lays
out some legislative priorities the panel
believes FDA should follow with the
new funds (http://appropriations.house.
gov/uploadedfiles/hrpt-112-ap-fy13agriculture.pdf).
FDA should narrow the focus of its
menu labeling rule, scrap a controversial
dietary supplement guidance and report to
lawmakers on the delay in implementing
the FDA Food Safety Modernization Act
regulations, the report says.
The committee says FDA should
narrow its definition of “similar retail
food establishments" in the April 6, 2011
proposed menu labeling regulation (see
FCN April 8, 2011, Page 12).
Passed in March 2010, the Patient
Protection and Affordable Care Act
requires nutrition labeling of standard
menu items for chain restaurants, similar
retail food establishments and chain
vending machines with 20 or more
locations. Under the proposed rule,
consumers would see calories listed
in restaurants and similar retail food
establishments that are part of a chain,
such as grocery and convenience stores,
with 20 or more locations doing business
under the same name and offering for sale
substantially the same menu items.
The supermarket lobby has been
advocating for FDA to drop food retailers
and wholesalers from the final regulation,
saying the costs would be too high to
implement and Congress never intended
the restaurant labeling law to apply to
supermarkets.
In the new report on the FY ’13
spending bill, the congressional committee
speaks out about the choice FDA should
make in the final menu labeling rule.
"The committee urges FDA to use the
proposed alternative ‘Option 2’ definition
in the rule to mean only restaurants or
retail establishments where the primary
and majority of business is the selling of
food for consumption or the selling of
food that is processed or prepared on the
premises,” the report says.
Additionally, the report suggests FDA
withdraw its July 2011 guidance on New
Dietary Ingredients (NDI) for Dietary
Supplements and “re-engage the dietary
supplement community to develop a
new guidance on what constitutes NDI.”
The panel expresses concern that FDA
is already using the draft guidance
for enforcement activities against
manufacturers although it is still in draft
form (see related article, Page 11).
The spending panel also makes it clear
that it is aware that FDA has missed the
Jan. 4, 2012 FSMA statutory deadlines for
publishing a fresh produce safety rule and
final regulations for the Foreign Supplier
Verification Program for imported food.
“The committee encourages the
administration to meet the statutory timelines
for implementing PL 111-353 and expects
FDA to follow a timeline for issuing
rulemakings consistent with the sequence and
logistics of establishing requirements for a
preventive controls framework for domestic
and imported foods,” the report says.
FDA should issue a report in 180 days
that describes the justification for any
proposed rule or final regulation being
60 days or more beyond the timeline, the
committee suggests.
The panel also urges FDA to issue a
final seafood advisory by July 31, 2012
and to help USDA adopt the same glutenfree adoption FDA is planning to release
in a final rule by the end of 2012.
“The committee encourages FDA to work
with USDA to assist its agencies in adopting
the definition of gluten-free set by the
FDA final rule to provide uniform labeling
requirements and best protect consumers
with celiac disease and other conditions.”
Additionally, the committee report
recommends FSIS issue a final rule to
modernize poultry inspections by Oct.
1, 2012, a reference to the controversial
HACCP-based Inspection Models
Project (HIMP), and that the 23 fulltime equivalent staff appropriated in FY
2009 for enforcing Humane Methods
of Slaughter Act are dedicated solely to
overseeing compliance with the human
handling rules for live animals as they
arrive and are offloaded and handled in
pens, chutes and stunning areas.
EPA changes Clean Air Act standards for soot
but leaves dust unchanged
By Amber Healy
M
aking good on a pledge
she issued last fall, EPA
Administrator Lisa Jackson, on
June 15, released proposed changes to the
National Ambient Air Quality Standards
that don’t call for tighter controls on dust.
Farm groups were worried that Jackson
would call for a new standard on dust
that could bring some regions into noncompliance with the regulations during
dry spells or drought conditions (see FCN
Oct. 21, 2011, Page 11).
EPA is required to review the Nation
Ambient Air Quality Standards as part of the
© Informa Ltd 2012
Clean Air Act every five years. EPA’s current
standard, which will be maintained, allows
for 150 micrograms per cubic meter of coarse
particulate matter in the air. Earlier, Jackson
had suggested EPA was considering tightening
the standard to 65-85 micrograms per cubic
meter (see FCN July 19, 2010, Page 35).
In a statement on EPA’s website (http://
yosemite.epa.gov/opa/admpress.nsf/
bd4379a92ceceeac8525735900400c27/f5
1c2fdeda736ea285257a1e0050c45f!Open
Document) announcing a revised standard
for soot, which calls for a limit of 12 to 13
micrograms per cubic meter, down from
the current standard of 15 micrograms per
cubic meter, Jackson emphasizes that “the
proposal has zero effect on the existing daily
standard for fine particles or the existing
daily standard for coarse particles (PM10),
both of which would remain unchanged.”
The announcement was welcomed by
the National Cattlemen’s Beef Association,
but Ashley McDonald, the organization’s
deputy environmental counsel, warned that
things still could change in the future.
“We learned from the last two reviews
of this standard that a final standard can
look very different from the proposal,”
McDonald warns. “It is important to
note that EPA's action today is simply a
Clean Air Act ► 14
13
June 22, 2012
Interagency
Clean Air Act ◄ 13
proposal and not the final standard,” which
will be released in December, she says.
If EPA maintains this proposal in the
final standard, “such an action would only
provide us with certainty for five years and
provides no relief to those producers who
are spending more than $1,000 per day on
dust control measures right now."
EPA released the proposed standards in
the June 20 Federal Register. Comments
will be accepted for 63 days, until Aug. 31.
NCBA also has supported legislation,
introduced by Sen. Mike Johanns (R-Neb.)
and Rep. Kristi Noem (R-S.D.), which
would exempt agricultural operations from
having to comply with EPA dust regulations.
would be able to move their proposed bill
through the chamber in enough time to
conference and adopt the new Farm Bill by
its expiration date of Sept. 30.
The Senate and House bills both include
the framework Stabenow and House
Agriculture Committee Chair Frank Lucas
(R-Okla.) and their ranking members
agreed to last fall, as part of a federal deficit
reduction effort, Stabenow said.
“I’m confident we’ll get this done,” she said.
The House Agriculture Committee is
scheduled to take up deliberations on its
draft Farm Bill on July 11.
American agricultural products overseas,
including oranges, grains and other
agricultural goods.
Just last week, when it was revealed
that Coburn’s amendment to cut MAP’s
funding was to be brought up for a vote,
some 80 members of the ad hoc Coalition
to Promote U.S. Agricultural Exports wrote
a letter to Stabenow and Sen. Pat Roberts
(R-Kan.), the ranking member of the Senate
agriculture committee, urging opposition
to the amendment. The organizations,
which included the American Feed Industry
Association, American Meat Institute,
National Corn Growers Association,
National Cotton Council, National Milk
Producers Federation and National Potato
Council, among others, said cutting the
program’s funding “would seriously
undermine U.S. agriculture’s ability
to compete in this highly competitive
international marketplace.”
Farm Bill vote ◄ 1
lower rate. The amendment was approved
by a vote of 63-36.
Overall, by Wednesday evening, the
Senate had discussed all but a handful of
the 73 amendments brought to the floor,
a list which – just a few days earlier –
stood at 300 (see FCN June 15, 2012,
Page 1). Of the 65 amendments discussed,
including two motions to recommit the
bill to the Senate for alternations and
resubmissions, 39 were approved, 22 were
rejected and five were dropped.
Among the amendments rejected was
one introduced by Sen. Rand Paul (R-Ky.)
that would have created income limits for
participants in the Supplemental Nutrition
Assistance Program (SNAP, formerly food
stamps), and another from Sen. Kirsten
Gillibrand (D-N.Y.) that would have
reinstituted some SNAP funding cut in the
proposed bill and increase funding for the
fresh fruit and vegetable program with an
offset to limit crop insurance reimbursements
to providers. Paul’s amendment was rejected
by a vote of 84 to 15; Gillibrand’s amendment
was rejected by a vote of 66 to 33.
Stabenow: “This is not your father’s
Farm Bill”
“This is not your father’s Farm Bill,” Sen.
Debbie Stabenow (D-Mich.), chair of the
Senate agriculture committee, said during a
call with reporters Wednesday morning. She
pointed to the increased emphasis on organic
and locally produced food, noting that a few
amendments that would have cut funding
to organic programs were rejected by the
Senate on Tuesday.
She said also that $15 billion of the $23
billion in savings in the 2012 Farm Bill over
the 2008 law comes from the streamlining
of conservation programs, paring down the
pool of programs from 23 to 13.
Deliberations on the bill were slated to
be wrapped up on Thursday, with a final
vote expected by today.
Stabenow predicted, during the call with
reporters, that her counterparts in the House
14
Catfish amendment approved
The Agricultural Reform, Food and Jobs
Act of 2012 (S 3240), the formal name for
the 2012 Farm Bill, also set the stage for
the possibility of bigger changes at USDA.
One of the early amendments that
earned a wide approval was the amendment
submitted by Sens. John McCain (R-Ariz.)
and John Kerry (D-Mass.), to eliminate
language from the 2008 Farm Bill that
gave USDA the authority to create a catfish
inspection program (see FCN June 15, 2012,
Page 19).
Sen. Mark Pryor (D-Ark.) stood up
in opposition of the bill, saying better
protections for American consumers were
needed from imported fish from Vietnam,
Thailand and other countries where
catfish-like species were raised in “sewage
water.” He added that imported seafood
has been found to contain veterinary drugs
and other chemical residues not approved
for use in the U.S.
Another amendment that would have
reduced funding for USDA’s Market
Access Program was rejected. The
amendment, offered by Sen. Tom Coburn
(R-Okla.), would have cut $40 million
in funding for the $200 million-per-year
program, while also prohibiting the use of
funds for reality TV shows, wine tastings,
animal spa products and cat or dog food.
MAP provides money to promote
Poultry protection rule rejected, but
feed research approved
A pair of amendments dealing with
poultry provided mixed results.
Before the Senate began discussing
the amendments Tuesday afternoon, it
rejected an amendment offered by Feinstein
that would have required larger cages for
egg-laying hens and mandated that all egg
cartons be labeled to distinguish whether
the eggs came from caged, free-range or
cage-free hens. Her amendment carried
the same language as in a pair of proposed
bills in the House (HR 3798) and Senate
(3239), but the Humane Society of the
United States was quick to lament the
amendment’s rejection.
“It is an outrageous subversion of the
process for Senate leaders to deny any
consideration of animal welfare issues
in the Farm Bill,” says Wayne Pacelle,
president and CEO of The Humane Society
of the United States, in a statement released
Farm Bill vote ► 15
© Informa Ltd 2012
June 22, 2012
Interagency
Farm Bill vote ◄ 14
Amendments approved for inclusion in Senate 2012 Farm Bill
Some other 73 amendments were presented for debate earlier this week by senators hoping to have them included in the 2012
Farm Bill. Here are a few of the 39 that were approved by Wednesday night.
Sponsor
Purpose
Vote
Sen. Maria Cantwell (D-Wash.)
Calls on USDA to add more peas, beans and legumes in school meal programs
58-41
Sen. Bob Casey (D-Pa.)
Calls on USDA to require more frequent reporting of dairy products and prices.
73-26
Sen. John Boozman (R-Ark.)
Would make available $1 million to the National Agricultural Library to partner
with agricultural universities on research projects.
Voice vote
Sen. Ben Nelson (D-Neb.)
Ensure performance bonuses used by state agencies are only administered to
carry out the Supplemental Nutrition Assistance Program
Voice vote
Sen. John Kerry (D-Mass.)
Would extend eligibility for certain emergency loans to commercial fishermen.
Voice vote
Amendments excluded from Senate 2012 Farm Bill
Some other 73 amendments were presented for debate earlier this week by senators hoping to have them included in the 2012
Farm Bill. Here are a few of the 22 that were voted down by Wednesday night.
Sponsor
Purpose
Vote
Sen. Jim DeMint (R-S.C.
Would have prohibited the mandatory involvement in check off programs
20-79
Sen. Jeff Sessions (R-Ala.)
Would have ended state bonus payments for administering the Supplemental
Nutrition Assistance Program
41-58
Sen. Pat Toomey (R-Pa.)
Would have eliminated the organic certification cost share assistance program
42-57
Sen. John Thune (R-S.D.)
Would have limited the amount of subsidy provided by crop insurance
programs to persons or entities with an adjusted gross income in excess of
$750,000
44-55
Sen. Saxby Chambliss (R-Ga.)
Would have eliminated funding for the Farmers Market and Local Food
Promotion Program
Tuesday. “Tens of millions of Americans
care deeply about the welfare of animals,
and this snub of that enormous and growing
constituency and their denial of progress on
critical policy reforms is unprecedented.”
But a coalition of farm groups, which
had slammed Feinstein’s legislation
and amendment as the “rotten egg” bill,
applauded the move.
“The egg industry is seeking to
establish egg factory cages as a national
standard that could never be challenged
or changed by state law or public vote,”
says Bradley Miller, national director
of the Humane Farming Association, in
a statement released Tuesday. “Senator
Feinstein’s amendments would preempt
state laws, such as California’s Proposition
2, and is a direct assault upon egg laying
hens,’ voters,’ and states’ rights.”
Another poultry-related amendment,
this one from Sen. Tom Carper (D-Del.),
was approved on a voice vote. It would
call on USDA to make a “top priority”
© Informa Ltd 2012
research into more efficient and nutrientdense feed options for poultry and other
livestock. Carper noted that, as the cost of
feed grains like corn increase, due in part to
increased ethanol production, farmers are
Voice vote
struggling to keep up with the rising prices.
Two-thirds of the cost of raising animals
comes from feed costs, and if farmers had
more options for feed, it might allow more
small farmers to stay in business, he said.
BREAKING NEWS: Senate rejects Sanders amendment
On Thursday aftermnoon, the Senate voted 26-73 to defeat an amendment
that would have allowed individual states to require labeling of all genetically
engineered foods.
The amendment, presented by Sen. Bernie Sanders (I-Vt.), was among the last eight
amendments to be considered for inclusion in the 2012 Farm Bill, and a vote on the
legislation is expected that afternoon.
The amendment, cosponsored by Sens. Barbara Boxer (D-Calif.) and Mark Begich
(D-Alaska), also had the support of 40 “pro-consumer” groups, including Public
Citizen, USPIRG and others, Sanders said in introducing the amendment.
Few of the other amendments that were voted on Thursday morning had anything to
do with food or agriculture. An amendment from Sen. Barbara Boxer (D-Calif.) that
would have permitted the EPA to conduct aerial inspections to detect signs of water
runoff and other sources of pollution was rejected, 47-47 under a rule that required
60 votes to pass. And an amendment from Sen. Mike Johanns (R-Neb.) which would
have prohibited the EPA from conducting aerial surveillance to detect signs of
pollution was rejected, 56-43, under the same rule.
15
June 22, 2012
International
U.S. dairy industry excited about Canada and Mexico
joining Trans-Pacific Partnership
By Jason Huffman
C
anada and Mexico have been
welcomed to participate in the
Trans-Pacific Partnership, though
the U.S. dairy industry is hoping for more
than just a superficial handshake.
Started almost exactly seven years ago,
the TPP is a multi-lateral trade agreement
originally signed by Brunei, Chile, New
Zealand and Singapore. In 2008, the U.S.,
Australia, Peru, Malaysia and Vietnam
joined the pact. By this time next year,
Japan is expected to join.
The 13th negotiating round of the TPP
is scheduled to take place, in San Diego,
July 2-10.
The National Milk Producers
Federation (NMPF), U.S. Dairy Export
Council (USDEC) and American
Chemistry Council (ACC) all issued
statements this week, expressing their
satisfaction with the latest news, along
with some expectations.
“The inclusion of Mexico and Canada
to the Pacific free-trade talks will enable
U.S. businesses to advance existing
commercial relationships with our North
American trading partners, while at the
same time broadening the scope and
impact of the negotiations,” the ACC says.
“American jobs depend on access to
important markets, and free trade agreements
such as the Trans-Pacific Partnership work
to remove trade barriers and ensure a level
playing field for United States chemical
manufacturers, which contributed $197
billion in exports in 2011.”
NMPF and USDEC, in their press
release, note that Mexico and the U.S.
already have removed all dairy-related
trade barriers between them, but “this is
not the case with respect to trade between
Canada and the United States.”
“The United States and Canada have
had a free trade agreement since 1988,
but it did not include dairy products,”
notes Jerry Kozak, president and CEO of
NMPF.”
“The U.S. dairy industry has tried for
many years to not only gain new access
to the Canadian dairy market, but also to
battle Canada’s attempts to undermine the
value of the very limited dairy concessions
granted in past WTO trade agreements,”
adds Tom Suber, president of USDEC.
“Unfortunately, we have made little
headway due to high tariff quotas that
continue in place despite NAFTA and
repeated steps by the Canadian government
to introduce new regulatory barriers to
our products. Our industry will absolutely
not support any agreement that does not
address full market access for U.S. dairy
products in the Canadian market.”
Walkom: Canada has little to gain
Meanwhile, in an article written for
The Star, a Toronto-based newspaper,
columnist Thomas Walkom suggests the
development is not such a big deal for
Canada, which already has free trade
agreements with Mexico, Chile, Peru and
the United States. “The remaining six
[nations] -- Vietnam, Malaysia, Singapore,
New Zealand, Australia and Brunei -aren’t giants of the world economy,” he
says.
In 2008, a spokesperson for Prime
Minister Stephen Harper dismissed the
talks as not worth the trouble, Walkom
says.
“What is important about the proposed
Trans-Pacific pact, however, is that it may
end up becoming the world’s premier
trade arrangement,” he adds. “That’s
because the U.S. hopes to use this deal
to bypass a decade-long deadlock in
negotiations at the 155-member World
Trade Organization.”
But Walid Hejazi, associate professor
of international business at the Rotman
School of Management at the University
of Toronto, also sees a significance in the
TPP deal for Canada. Canada currently
does 90% of its trade with the U.S.,
Europe and Japan, he recently told The
Star. These markets are massive, but they
are also slowing down sharply because
of aging populations and sky-high debt
levels, he said. The countries in the TPP
will be hugely important for Canadian
companies in the coming decades because
of their growth potential and proximity
to China.
EU poised to allow lactic acid treatment
for meat carcasses
T
he European Union is poised
to allow meat carcasses in
slaughterhouses to be treated with
lactic acid, Agra Europe reports.
Member-state representatives on the
EU's Standing Committee on the Food
Chain and Animal Health (SCoFCAH)
could reach a qualified majority of
countries needed to secure the change as
early as this week, sources suggest.
The move would pave the way for
the United States to fill its import quota
16
for “high-quality” (hormone-free) beef,
which was granted to end the transatlantic
dispute over use of growth hormones
in raising beef cattle. Washington has
previously stated that filling the quota
would depend on EU approval of
lactic acid, which is commonly used to
decontaminate carcasses in North America
(see FCN Feb. 10, 2012, Page 13).
European Commissioner for Health
and Consumers John Dalli is scheduled
to travel to the United States next week
in expectation of the rule change, Agra
Europe understands. The European
Parliament could yet veto the move
when it enters a three-month regulatory
oversight procedure, though the European
Food Safety Authority (EFSA) has already
approved the use of the acid to reduce
microbial contamination.
Most EU member-states are likely to
insist that meat treated with lactic acid
be labeled as such in order to inform
consumers.
© Informa Ltd 2012
June 22, 2012
Labeling & Advertising
FDA plans eye-tracking study to test
consumer reaction to food labels
By Joan Murphy
F
DA is embarking on two new food
labeling studies to capture eyetracking information and gauge
consumer reaction to food labeling claims
and symbols on food packages, the agency
reveals in a June 15 Federal Register
notice.
Eye tracking is a consumer research
technique that tests a person’s reaction to a
visual display, such as product packaging,
and can provide information on the
amount of time spent looking at different
packaging elements and what capture an
individual’s attention.
FDA says it plans to conduct both a
laboratory study and an in-store study,
not only to test how visual elements on a
label influence purchasing decisions, but
also to help inform the agency in relation
to the design of questionnaires for online
experimental studies on food packaging.
Comments on the notice, entitled Eye
Tracking Experimental Studies to
Explore Consumer Use of Food Labeling
Information and Consumer Response to
Online Surveys, are due Aug. 14.
The two studies will provide
background information to help identify
and develop more effective labeling
information and education in the future,
FDA says. “The results of the studies will
neither be used to develop population
estimates nor be directly used to inform
policy.”
However, FDA has signaled its intent
to publish a rule that would change
the Nutrition Facts panel, give more
prominence to calorie declarations and
update serving size information. The
agency also is looking at proposing
recommendations for a front-of-package
nutrition rating system, an effort that
sprung up because of concerns about the
number of competing rating systems in the
marketplace and questions about consumer
confusion from label clutter.
FDA says it plans to compare the
laboratory and in-store studies to see if the
results in the lab correspond to shopping
behavior.
For the laboratory study, participants
will view computer screen mockups of
food labels to test their reaction to one or
more label symbol or labeling statements.
“Examples of these characteristics
include: (1) The presence or absence of
a specific component (e.g., a nutrition
symbol); (2) the presence or absence of
other labeling components on the panel
(e.g., a ‘Rich in Antioxidant Vitamins’
statement); (3) the degree of clutter on the
panel (e.g., the number and prominence
of pictorial images); (4) the relevance
or irrelevance of the component (e.g.,
‘cholesterol free’ statement on a savory
snack product versus the same statement
on a vegetable oil product); and (5) the
featured nutrient or health benefit (e.g.,
‘helps protect immune system’ versus
‘supports a healthy cardiovascular
system’).”
The laboratory study, which is
to involve 200 participants, will be
designed to test how time pressure affects
information processing for busy shoppers,
FDA says.
During the in-store study, FDA says it
will observe 60 participants and record
eye-movement data to provide a better
understanding of subconscious and
conscious factors that influence food
purchases. Participants, who will be
recruited at storefronts from two
locations, will only be eligible to
participate if they plan to shop for
products in preselected categories. They
will not be restricted to which products
they examine or how much time they
spend during their shopping trips
“The data will be used to test
hypotheses such as whether product
familiarity or personal needs will
cause variations in information seeking
and whether design elements (e.g.,
prominence, text vs. graphics) will cause
variations in information seeking,”
FDA says.
CSPI: Girl Scouts sell cookies, not candy bars
By Amber Healy
G
irl Scout cookies might be an
acceptable way to promote the
100-year-old program that helps
girls learn a variety of skills, but the
trademarked cookie flavors and logo
should not also be used on candy bars
that are consumed by children and adults
alike, the Center for Science in the Public
Interest says in a two-page letter to Nestlé
USA this week.
Nestlé is currently selling three
varieties of its Crunch candy bars in
flavors modeled after Girl Scout cookie
favorites: Peanut Butter Crème, Thin Mint
© Informa Ltd 2012
and Caramel & Coconut. To help promote
the candy bars, Nestlé includes, on the
wrappers, the Girl Scout logo, which
CSPI says is a violation of the Children’s
Food and Beverage Advertising Initiative
(CFBAI). Nestlé is one of the more
prominent companies to have signed on to
the initiative, which restricts the marketing
of unhealthy food to children under the
age of 12.
“Even if the candy bar advertising is
targeted towards adults, the Girl Scout’s
theme is inherently appealing to children
and so constitutes marketing to children,”
says Margo Wootan, CSPI’s director
of nutrition policy, and Lori Dorfman,
director of the Berkley Media Studies
Group at the Public Health Institute, in the
letter sent Monday.
“It’s not credible for the company to
claim these are marketed exclusively to
adults, any more than if their labels bore
Dora the Explorer instead of the Girl
Scouts,” Wootan says, in a separately
issued press release, referring to a popular
animated TV character.
CSPI points to a report from the Federal
Trade Commission, released in 2008, that
recommends companies consider whether
any product that might be sold to children
Girl Scouts ► 18
17
June 22, 2012
Labeling & Advertising
Girl Scouts ◄ 17
might be marketed with characters, themes
or performers familiar to or appealing
to children, a connection clearly made
by using the Girl Scouts’ logo on the
wrapper, Wootan and Dorfman argue.
The 2010 Dietary Guidelines
determined that candy is the fourth-largest
source of sugar in American’s diets, they
note.
The candy bars are high in calories,
saturated fat and sugar, above levels
accepted by the CFBAI, and are higher
in those nutrients than the cookies
themselves, Wootan says. The Thin Mint
candy bar has 200 calories, 10 grams of
saturated fat and 16 grams of sugar; the
Caramel & Coconut bar has 190 calories,
9 grams of saturated fat and 17 grams of
sugar; and the Peanut Butter Crème candy
bar has 190 calories, 6 grams of saturated
fat and 13 grams of sugar.
In a statement provided to various
media outlets, Nestlé says there’s nothing
wrong with the candy bars.
“Contrary to the assertions of the
Center for Science in the Public Interest,
we are not engaging in child-directed
advertising or marketing for Nestlé
Crunch Girl Scout Candy Bars sold at
grocery stores, convenience stores and
mass market retail outlets which are
primarily adult-oriented venues,” the
company says. “Nestlé Crunch Girl Scout
Candy Bars were developed to appeal to
an adult audience, and our advertising
and marketing efforts are directed
accordingly.”
Peruvian industry strikes back at proposed food
advertising restrictions
By Steven Lewis, EU Food Law
C
onsumer advocates in Peru face an
uphill battle in their attempt to gain
approval for legislation restricting
the advertisement of “junk food,” because
a well-funded industry coalition is
determined to preserve self-regulation.
House Bill 1038, being debated by
Peru’s Congress this month, would charge
the country’s ministries of health and
education with providing instruction
about proper nutrition in schools. Sports
and physical activity would be promoted.
The sale of food high in sodium, sugar,
saturated fat or trans fats would be
prohibited within both public and private
schools. The bill would ban the advertising
of “harmful food products” from 6 a.m. to
10 p.m.
“This bill is a classic example of invasive
legislation espoused by those who distort
genuine concerns in an attempt to impose
arbitrary regulations that are clearly
ineffective in addressing the problems they
intend to resolve,” says a coalition
of opponents, headed by the National
Council for Publicity Self-Regulation
(CONAR), in a position statement issued
on May 10.
“In addition, this legislation violates
basic principles of free choice and personal
responsibility by putting the parent state
in the position of deciding not only what
the consumer should do, but what he/she
should see and hear.”
CONAR member media companies,
which account for 80% of Peru’s
18
total media coverage, are combining
forces with leading food processers to
launch a media campaign against the
legislation.
The ads argue that the bill unfairly
points the finger of blame for Peru’s recent
upsurge in childhood obesity at specific
categories foods and beverages.
“Obesity is the result of
a combination of
consumption and lifestyle
habits. This is a much more
complex issue than just
eating too many hamburgers
and chocolates”
– Peru’s National Council for
Publicity Self-Regulation
“Obesity is the result of a
combination of consumption and
lifestyle habits. This is a much more
complex issue than just eating too many
hamburgers and chocolates. It involves
a lack of physical activity as well as
misinformation on how to prepare and
eat food at home,” the CONAR statement
continues.
It accuses legislators of taking the easy
way out by glossing over the unhealthy
lifestyle of the average Peruvian and
placing the blame on international
companies that fight obesity by adhering to
voluntary advertising standards established
by CONAR’s Permanent Committee on
Ethics.
Delgado: “My friends, junk food
kills”
However, consumer advocates maintain
that current voluntary industry controls
leave much to be desired. Bill 1038
sponsor Rep. Jamie Delgado declares,
“Over the last 60 years, we abandoned
the dietary knowledge gained over 10,000
generations of human existence, and today
we consume food products which, far from
offering any noticeable nutritional value,
actually harm our health. My friends, junk
food kills.”
During his speech, presented at a
conference in Lima on “Nutrition and
Obesity: New Evidence, Ideas, and
Public Policies,” Delgado placed the
blame for Peru’s childhood obesity spike
on the consumption of hamburgers,
packaged snacks, soft drinks, and fast
food in general. Nevertheless, industry
leaders claim that Article 14 of his bill,
the section that would ban the advertising
of “harmful food products” from 6 a.m.
to 10 p.m., is an overreaction to the
problem.
CONAR and its politically influential
affiliates are prepared to use all of the
political ammunition at their disposal in
order to preserve the current system of
industry self-regulation. They won’t give
up easily, because severely restricting
advertisements for food that House Bill
1038 supporters describe as “harmful”
would put a dent in sales of Peru’s major
food processors as well as the media
companies that rely heavily on their
advertising dollars.
© Informa Ltd 2012
June 22, 2012
Packaging
EFSA says mineral oil hydrocarbon safety limits
need revision
C
urrent maximum safe intake
limits for certain mineral oil
hydrocarbons (MOH) need to be
revised to avoid potential health risks from
these contaminants, the European Food
Safety Authority (EFSA) warns.
Last December, the Confederation of
European Paper Industries (CEPI) and
the International Confederation of Paper
and Board Converters in Europe (CITPA)
announced a commitment to phase out
the use of mineral oils in paper products,
including food contact materials (see FCN
Dec. 23, 2011, Page 16). The decision
followed widely publicized concerns about
the safety of mineral oils used in printing
inks. Studies found traces of mineral oils
migrating into food from inks found on
the printed surface of packaging and in
recycled packaging papers.
In a scientific opinion on human
exposure through the diet to MOH, which
identifies some potential concerns about
food-based exposure to the contaminants,
EFSA’s Panel on Contaminants in the
Food Chain (CONTAM) has concluded
that the temporary Acceptable Daily
Intakes (ADIs) of some saturated MOH
present in specific food products warrant
revision, EU Food Law reports.
The opinion, issued last week, explains
that the potential human health impact of
MOH varies widely. So-called aromatic
MOH may act as genotoxic carcinogens
(damaging DNA as well as causing
cancer), while some saturated MOH can
accumulate in human tissue and may cause
adverse effects in the liver.
However, EFSA’s experts stress there are
several uncertainties regarding the chemical
composition of MOH mixtures to which
humans are exposed and also wide range of
sources of human exposure. Furthermore, on
the basis of new information on the lack of
toxicological relevance for humans of previous
animal studies, the temporary ADIs of some
saturated MOH present in specific food
products need to be revised, the panel says.
MOH comprise a diverse group of
mixtures of hydrocarbons containing
thousands of chemical compounds of
different structures and size, derived mainly
from crude oil but also produced synthetically
© Informa Ltd 2012
from coal, natural gas and biomass, EFSA
explains in a statement on the opinion.
It adds that the chemical composition
of most MOH mixtures is unknown
and usually varies from batch to batch.
Specifications are often expressed in terms
of viscosity, or ‘thickness,’ as related to
the applications of the products and not in
terms of chemical composition.
There are several possible sources of
MOH in food: mainly food packaging
materials, food additives, processing aids
and environmental contaminants such as
lubricants.
“The presence of both
saturated and aromatic
mineral oil hydrocarbons in
dry foods, including pudding
dessert mixes and noodles,
may be partially attributed to
the use of recycled paper and
cardboard packaging”
– EFSA’s Panel on
Contaminants in the Food
Chain (CONTAM)
Experts on EFSA’s CONTAM Panel
identified two main types of MOH relevant
for food safety: saturated and aromatic
hydrocarbons. The CONTAM Panel
carried out an assessment of consumer
exposure to MOH, including background
or low-level presence in food.
From the available data, low levels of
saturated MOH were present in all the food
groups included with some high levels found
in bread and rolls and grains for human
consumption, due to their use, respectively,
as release/non-sticking agents and spraying
agents (used to make grains shiny).
The presence of both saturated and
aromatic MOH (although data are more
limited for the latter) in dry foods,
including pudding dessert mixes and
noodles, may be partially attributed to
the use of recycled paper and cardboard
packaging. Exposure to saturated MOH
through the diet was higher among younger
consumers than for adults and the elderly.
In terms of the risk associated with
exposure to MOH in food, the CONTAM
Panel concluded there may be a potential
concern for some consumers: specifically,
customers who are brand loyal or who
often buy the same food product from the
same shop may be exposed on a regular
basis to food with higher levels of MOH.
Although the establishment of new
health-based guidance values for MOH
products used as food additives was outside
the scope of the opinion, the CONTAM
Panel concluded that the opinion provides
a suitable basis for revising the temporary
group ADI of some low- and mediumviscosity MOH intended for food use.
These MOH products were evaluated
by the former Scientific Committee on
Food (SCF), which was EFSA’s forerunner
when it came to offering the European
Commission scientific advice, and by
the Joint FAO/WHO Expert Committee
on Food Additives (JECFA), which is
currently reviewing its opinion.
EFSA says that recent information
considered for the opinion published last
week indicated that the accumulation
of saturated MOH in the lymph nodes
found in the gut of laboratory animals is
less relevant for human health than was
thought at the time this temporary group
ADI was set. Therefore the CONTAM
Panel considers the revision of the ADIs
for high-viscosity MOH a low priority.
The panel couldn’t calculate the risk
associated with exposure to aromatic MOH,
which are both genotoxic and carcinogenic,
because of insufficient information both on
exposure and toxicology. However, “in view
of the carcinogenic properties of this type of
MOH, the panel considered exposure to this
type of MOH as being of potential concern.”
EFSA’s opinion also makes a series
of recommendations for improving
methods of analysis and data collection
and monitoring, as well as indications
for possible future priorities of scientific
research on MOH.
In 2009, EFSA’s Panel on Food
Additives and Nutrient Sources added to
Food published an opinion on the safety of
high-viscosity white mineral oils (HVMO)
when used as food additives, establishing
an ADI of 12 mg/kg/bw/day.
19
June 22, 2012
Pesticides
Farm group says “Dirty Dozen” list contributes to
obesity problems
By Larry Pearl
T
he Alliance for Food and Farming
(AFF) has released its own report in
an attempt to combat the potential
negative impact of fruit and vegetable
sales resulting from the Environmental
Working Group’s annual “Dirty Dozen”
list.
As it does every year at about this
time, EWG on June 19 released the eighth
edition of its Shoppers Guide to Pesticides
in Produce (www.ewg.org/foodnews/).
The report, as usual, includes a list of the
produce items which EWG found to most
often contain a high level of pesticide
residues. EWG calls the list its “Dirty
Dozen Plus,” since this year it identifies 14
items of produce, including apples, celery
and bell peppers. The report also includes
EWG’s “Clean 15” list, which is led by
onions, sweet corn and pineapples.
EWG explains that it comes up with its
rankings based on a combination of six
measures and employs 10 years’ worth of
information collected by USDA’s Pesticide
Data Program, which includes pesticide
residue results from thousands of food
and water samples covering several dozen
commodities.
But AFF, a Watsonville, Calif.based group that supports organic
and conventional farmers, is calling
on EWG to stop publishing its “Dirty
Dozen” lists until the group shows it is
not discouraging produce consumption,
especially among low-income individuals,
a claim that EWG disputes. As part of its
efforts to counter the EWG report, AFF
on June 19 released a report, “Scared Fat,”
which features the results and analysis
of a nationwide online survey conducted
in April of 800 U.S. adults (www.
safefruitsandveggies.com/sites/default/
files/AFF-ScaredFatRpt_Final.pdf).
In the survey, after hearing negative
messages about pesticides and biotech
food, taken from EWG, almost 10% of lowincome consumers said they would reduce
their consumption of fruits and vegetables
while another 9% said they were unsure
what they should do, AFF reports.
20
“Despite continuous and repeated
government campaign initiatives
communicating about the need to eat more
fruits and vegetables, [EWG’s] messaging
results in almost 20 % of the low income
population considering discounting those
nutrition based initiatives and advice,”
AFF Executive Director Marilyn Dolan
says in a June 19 press release.
But whether such pesticide-related
messages are actually reducing sales and
consumption of fruits and vegetables is
unclear. Consumption of fruits and vegetables
in the overall population has been flat over
the past 20 years, with a modest increase
in consumption among children aged 2-12,
along with decreased consumption by the
elderly and teenagers. And there is minimal
research linking those consumption trends to
concerns about pesticide residues.
In one survey, done in January 2011,
twice as many respondents said they
avoided fruits and vegetables in the
preceding three months due to concerns
over pesticides compared to concerns over
foodborne illness.
With its survey results indicating an
increased propensity for individuals
to avoid fruits and vegetables when
confronted by negative information on
pesticide residues, AFF says it “is calling
on the EWG to stop using and promoting
their list.”
Formuzis: Price and preference are
cause, not pesticides
In a June 19 press release, EWG
acknowledges that its Shopper’s Guide
“is not built on a complex assessment
of pesticide risks but instead reflects
the overall pesticide loads of common
fruits and vegetables.” The group asserts
that “this approach best captures the
uncertainties of the risks of pesticide
exposure. Since researchers are constantly
developing new insights into how pesticides
act on living organisms, no one can say
that concentrations of pesticides assumed
today to be safe are, in fact, harmless.”
In addition, running a truly risk-based
analysis may be impossible because
commodities can have residues from
multiple pesticides and no one has looked
at the combined effect of those pesticides,
EWG spokesperson Alex Formuzis tells FCN.
“Our top shelf message since 1993
has been ‘always eat your fruits and
vegetables,’” he says. The risk of not
eating a diet rich in fruits and vegetables
is much greater than eating fruits and
vegetables with pesticides.
Formuzis also disputes the notion that
the “Dirty Dozen” list and associated
messages from EWG prompt people
to avoid buying fruits and vegetables.
If someone chooses to eat junk food
over fruits and vegetables, they’ll do
it regardless of pesticides, they’ll do it
because they want to eat junk food, he
tells FCN.
He further notes that AFF’s own
experts say the cause of flat produce sales
are availability, price and preference, not
pesticides. And he points to the results
of AFF’s survey, which found that lack
of pesticide residues was the third most
important factor in purchasing fruits and
vegetables, behind ‘safety from contamination
and food-borne illness’ and cost.
At the same time, Formuzis points to
the increasing popularity of organic foods,
whose U.S. sales rose 9.5% last year to
$31.5 billion (according to the Organic
Trade Association) and says that those
who want to eat fruits and vegetables are
increasingly concerned about pesticides.
“People who use our guide are those
who want to eat fruits and vegetables …
without eating as many pesticides as they
might otherwise consume,” he says.
Baby food concerns
For the first time since its inception in
1991, USDA’s Pesticide Data Program
(PDP) report looked at pesticide residues
in baby food, analyzing samples of
baby food pears, green beans and sweet
potatoes (see FCN June 1, 2012, Page 1).
While USDA, EPA and FDA say the
pesticide levels detected in baby food do
not pose a safety concern and highlight the
fact that no approved pesticides were found
Dirty Dozen ► 21
© Informa Ltd 2012
June 22, 2012
Pesticides
Dirty Dozen◄ 20
EWG Shoppers Guide to Pesticides in Produce (8th Edition)
above the legal limit, and only a handful
of samples contained unapproved
pesticides, EWG points to the overall
number of pesticides detected on baby
food pears and green beans.
“Legal isn’t always safe,” the group
stresses in reference to the small number
of pesticide tolerance violations found
on all samples tested.
In terms of overall pesticide load,
the worst of the three baby food
items, according to EWG, was pears.
Some 92% of the pear samples tested
contained at least one pesticide while
26% contained five or more pesticides.
A total of 15 different pesticides were
detected on baby food pears.
“This year’s [shopper’s] guide will
also give parents pause,” EWG President
Ken Cook says in the group’s June 19
press release. “Government scientists
have found disturbing concentrations
of pesticides in some baby food,” he
continues.
Cook sees the findings from the latest
PDP report as cause for more action.
“Environmentalists have had important
successes in forcing pesticides that
presented unacceptably high dietary risks
off the market. The latest USDA tests
show we have much more work to do,”
he says.
EWG comes up with the rankings for its “Dirty Dozen” and “Clean 15” by using six
different metrics that are treated equally. Based on information from the past 10 years
of USDA Pesticide Data Program reports, for each commodity it finds the following:
• Percent of samples tested with detectable pesticides;
• Percent of samples with two or more detectable pesticides;
• Average number of pesticides found on a single sample;
• Average amount (in parts per million) of all pesticides found;
• Maximum number of pesticides found on a single sample; and
• Total number of pesticides found on the commodity;
For each metric, it produces a score from 1 to 100. It then adds up the scores from all
six metrics to come up with the following ranking:
Dirty Dozen-Plus
Apples
Celery
Sweet Bell Peppers
Peaches
Strawberries
Nectarines (imported)
Grapes
Spinach
Lettuce
Cucumbers
Blueberries (domestic)
Potatoes
Green Beans*
Leafy Greens (Kale/Collard Greens)*
Clean 15
Onions
Sweet Corn
Pineapples
Avocado
Cabbage
Sweet Peas
Asparagus
Mangoes
Eggplant
Kiwi
Cantaloupe (domestic)
Sweet Potato
Grapefruit
Watermelon
Mushrooms
*EWG added two crops to the “Dirty Dozen” list for a total of 14, saying that though these two
crops did not meet traditional “Dirty Dozen” criteria, they were often contaminated with highly
toxic organophosphate insecticides.
USDA
USDA seeks “temporary” inspectors
to help expand HIMP
By Amber Healy
J
ust three weeks after the comment
period closed on USDA’s proposed rule
for modernizing the poultry slaughter
and inspection process, and with the
status of the program still up in the air, the
agency is looking to hire some temporary
inspectors to help expand its use.
Posted last week on USAJobs.com,
the Food Safety and Inspection Service’s
single job advertisement looks to fill a
“few vacancies” in Nixon and Seguin,
Texas; Laurel, Miss.; Broken Bow, Okla.;
© Informa Ltd 2012
and Smithfield, Va. (www.usajobs.gov/
GetJob/ViewDetails/318165500). The ad
is for inspectors who would only work for
the agency for one year.
“As FSIS transitions through
modernization and implements the
New Poultry Slaughter Inspection
System, temporary Food Inspector
positions are being announced to
facilitate the transition and to help
ensure seamless implementation,” the job
posting says. “While there are specific
conditions associated with temporary
employment cited in this announcement,
temporary positions do give candidates
valuable work experience that may
be useful in their future employment
endeavors.”
FSIS has yet to publish a final rule on
the proposed expansion of its HACCPbased Inspection Models Project (HIMP),
which was introduced in January, and
for which the agency received more than
2,200 comments by the time the comment
period ended on May 29 (see FCN June 1,
2012, Page 21).
HIMP ► 22
21
June 22, 2012
USDA
HIMP ◄ 21
No guarantees
FSIS’ job posting notes that “there is
no guarantee of future employment with
FSIS once the temporary employment
ends” at the end of a one-year position,
but suggests that the training received
during the employment period “may help
you qualify for positions in FSIS once
modernization has taken place and new
positions are open to the public.”
That’s what makes it different than FSIS’s
usual advertisement for an “intermittent,”
or other-than-permanent, inspectors that are
hired to fill in, on a full- or part-time basis,
and are eligible to work up to 1,280 hours
per year, says Stan Painter, chair of the
National Joint Council of Food Inspection
Locals, the union representing the agency’s
more than 6,000 inspectors. Those inspectors
are eligible for unemployment benefits at the
end of their contract year, and can choose to
work a full- or part-time schedule based on
their preferences.
These intermittent inspectors are intended
to fill short-term vacancies, like covering for
vacations or illnesses, Painter says.
Painter, who has worked as a poultry
inspector for 27 years, says he’s never seen a
posting for a temporary inspector position.
The temporary inspectors FSIS is
seeking would either be full- or part-time
employees, and would work for a one-year
period that may be extended for another
year. They would not be eligible to join the
inspectors’ union, and Painter questions
whether unemployment benefits would be
available to these workers.
In the past week, since the ad was
posted, Painter says his email has been
“blowing up” with questions from
inspectors wondering if they should
apply for these jobs. He’s advising
them that “this is not a path to full-time
employment,” and telling them if they’ve
got a full-time job, to keep it.
Painter also advises that FSIS prohibits
inspectors who used to be employed
by the industry from working as an
inspector in a plant where they were
previously employed for at least one year,
a prohibition he’s not sure would stay in
place for the temporary workers.
Tony Corbo, a senior policy analyst with
Food & Water Watch, questions whether the
temporary inspectors are part of an effort to
help with a loophole in the proposed rule that
does not specify what kind of training would
be required of the poultry plant workers who
would take on quality check duties currently
carried out by federal inspectors. Corbo
suggests that the plants might wind up hiring
the temporary inspectors after their year-long
contract is up.
Hiring temporary inspectors is “one
way to train company employees at
taxpayer expense for a year,” he says.
FSIS says in the proposed rule that
it would not going to mandate any
particular kind of training for plant
employees, but that it would make available
some guidance to plants that volunteer
for the HIMP program (see FCN Feb. 24,
FSIS extends comment period on
draft validation guidance
By Amber Healy
USDA’s Food Safety and Inspection
Service will provide an additional 30 days
for interested stakeholders and the public
to comment on its second draft guidance
for HACCP validation, the agency
announced June 15.
In its weekly Constituent Update
newsletter, the agency says it is extending
the deadline for public comments from July
9 to August 9, in response to “a request from
an industry association that stated that small
businesses with multiple HACCP processing
22
categories need additional time to evaluate
the draft guidance document.”
One of three major changes rolled
out in May, the validation guidance is
designed to tell plant managers how they
can demonstrate that the interventions and
critical control points included in their
HACCP plans are sufficient and properly
implemented (see FCN May 11, 2012, Page
17). A previous draft, published in March
2010, was met with frustration from meat
and poultry processors, who said it was
confusing and, at points, contradictory (see
FCN June 21, 2010, Page 27).
2012, Page 1). Language in the House
FDA-USDA appropriations bill for FY
2013, released Monday, supports the
agency’s plan to use plant employees
to conduct safety checks as a way to
save FSIS money, but also “strongly
recommends that FSIS require plant
employees to be trained before assuming
inspection responsibilities.”
Also online...
This week in Food
Chemicals News Guide
Now included with your Food Chemical News
subscription, Food Chemical News Guide is
the authoritative source for the regulatory
status of food additives and colorings. This
unique reference tool provides you with
detailed, comprehensive regulatory data,
and reports the changes in the regulation
of food additives, color additives and GRAS
substances. Weekly updates online and in
print, with searchable online databases.
Chemicals updated this week:
• algal oil (Chlorella protothecoides)
• Bifidobacterium animalis subsp. lactis strain
Bf-6
• canola protein isolate and
hydrolyzed canola protein isolate
• colostral whey protein concentrate and colostral
low molecular weight whey protein fraction
• cultured [dairy sources, sugars, wheat, malt
and fruit- and vegetable-based sources]
fermented by [Streptococcus thermophilus,
Bacillus coagulans, Lactobacillius acidophilus,
Lactobacillus paracasei subsp. paracasei,
Lactobacillus plantarum, Lactobacills
sakei, Lactobacillus burglaricus and
Proprionibacterium freudenreichii subsp.
shermanii or mixtures of these strains]
• enzyme modified sterviol glycosides
• erythritol
• lutein
• lutein diacetate
• magnesium dihydrogenpyrophosphate (MDPP)
• maleated isoprenyl polymer with methoxypolyethylene glycol (MIP-MPEG)
• milk mineral concentrate
• phytic acid
• plant-derived esterified and non-esterified
sterols and stanois (phytosterols)
• rebaudioside A purified from the leaves
of Stevia rebaudiana (Bertoni) Bertoni
(rebaudioside A)
• sedaxane
• steviol glycosides with stevioside as the
principal component
• sugar beet fiber
• suspended leutin
• tuna oil
© Informa Ltd 2012
June 22, 2012
On the FrontSection
Burner
T
he Fancy Food Show was going on, in Washington, D.C., this past week. That’s the big national expo that draws food
companies from 80 different countries. So we were in a mood to talk imports and guess who we saw at the conference: one
of the most experienced consultants at helping get food into the U.S.
10 Labeling Mistakes Importers Most Often Make
When Trying to Get Food into the United States
By Margaret Eckert
T
he terms “cocoa liquor” and “cocoa
mass” have the same meaning,
but use the wrong one on a food
label and be prepared to see your import
classified as misbranded and mislabeled,
leading it to be detained, recalled, reexported or even destroyed.
Though “cocoa mass” is the term used
in Europe and just about everywhere
else to describe cocoa beans that have
been ground into paste for use in milk
chocolate, in the United States “cocoa
liquor” is the “common or usual name,” as
is required by 21 CFR 101.4.
Since starting my work with the
German government more than 34 years
ago and my own consulting business a
little more than two years ago, I’ve helped
importing companies overcome common
labeling mistakes, like this one, to get
more than 5,000 products from about a
dozen countries into the U.S. market.
It’s not easy for foreign suppliers and
importers. Their food and beverage items
are at a disadvantage for several reasons.
For starters, there are language barriers
for the foreign suppliers, which are
compounded by the sometimes difficult to
understand regulatory jargon. Secondly, it
is much easier for regulatory officials to
check an imported product’s label at the
time of entry than to go to a supermarket
and do a visual check. And third, there is
no FDA label approval process. It is the
responsibility of each manufacturer to
make sure that he or she complies.
And now, with the implementation of
the FDA Food Safety Modernization Act,
it’s about to get even tougher.
Directly and indirectly, FSMA affects
labeling. Under the Foreign Supplier
Verification Program (FSMA sect. 301),
the regulations for which were supposed
to published by Jan. 4, 2012, importers are
responsible for vouching for the products
they are bringing in. This means that
manufacturers will have to make absolutely
sure that all aspects of their products
are safe and permitted, which means all
ingredients must be declared and allowed.
Allergens, especially, must be clearly
labeled. If the FDA performs an analysis
-- as the agency is doing increasingly
-- and finds, e.g. an undeclared allergen,
a product is automatically determined to
be misbranded and mislabeled and either
detained or recalled.
To help their readers who are foreign
companies and/or importers, Food
Chemical News asked me to share the
following list of 10 labeling mistakes I’ve
seen most often made recently with regard
to imported products:
1. Ingredients
This is a point that requires quite a
bit of explanation, especially since
the regulations in the U.S. are so very
different from those in other parts of the
world. I’ve already mentioned “cocoa
mass,” but there are several other ways to
ABOUT THE AUTHOR
Margaret Eckert (info@eurofoodsreg.com) is president of Eurofoods
Regulatory Advisors, LLC (www.eurofoodsreg.com), in Hicksville, NY. She
has more than 30 years of experience assisting foreign food and beverage
companies comply with all required regulations in order to successfully
export their products to the U.S. Prior to her current position, she was
director of trade relations for the German Agricultural Marketing Board –
CMA North American Office, a foreign government agency.
© Informa Ltd 2012
improperly identify an ingredient.
✓ E-Numbers: Europe started using
its number system to identify food
additives in 1962, creating directives for
preservatives in 1964, antioxidants in 1970
and emulsifiers, stabilizers, thickeners and
gelling agents in 1974.
E-numbers might work well in Europe,
but the translation of an E-number
ingredient is sometimes incorrect or not
according to the specified terminology
set here in the U.S. In many cases, an
E-number is either not permitted in the
U.S. at all or, in the case of certain colors,
it might only be permitted in a certified
form, as in the so-called FD&C (Food
Drug & Cosmetic Act) colors.
Some examples of E-numbers to give
you an idea of what I mean:
• E110 – It is known in the U.S. as
“Sunset Yellow FCF” or “Orange
Yellow S.” However, this color is only
permitted as FD&C Yellow #6 if it
comes from a color manufacturer, who
has manufactured the color according
to the regulations and has had it
certified by the FDA (21 CFR 74.706);
• E104 – It refers to “Quinoline
Yellow,” but the use of this color is
only permitted in the U.S. in drugs
and cosmetics, not foods;
• E122 – It refer to “Azorubine,
Carmoisine.” The use of this color
was never permitted in the U.S. and,
therefore, may not be used; and
• E120 – It refers to “Cochineal
Extract, Carmine.” The name of
this color must be declared in the
ingredients list with the function in
parenthesis behind it.
✓ “Natural” Ingredients: Plants, as
color additives, are permitted and used
in many countries around the world.
However, it would be prudent to double
check the regulations to make sure that
Eckert ► 24
23
June 22, 2012
On the Front Burner
Eckert ◄ 23
what you or your supplier plan to use is
allowed in the U.S. A frequent example
that I see is “safflower” as a color in
food and beverage products. Contrary
to popular belief, it is not permitted as a
color additive in the U.S.
✓ Allergens: There are vast differences
between the U.S. and other countries about
what is considered an allergen. The EU,
for example, includes sesame, mustard,
celery and mollusks as allergens, but that’s
not the case in the U.S. Declaring these
items as allergens, in parenthesis behind
the component in the ingredient list, in
the “Contains” statement or “Allergen
Warning Statement,” is a violation of the
U.S.’s Allergen Labeling Regulations.
In the FDA Enforcement Reports, you see,
time and again, that recalls were necessary
because of undeclared allergens. This is
an error that should not and cannot occur
and is easily avoidable. The manufacturer
must make sure that ALL ingredients,
and especially allergens, are listed in the
descending order of predominance by weight
in the ingredient list.
✓ Multi-Component Ingredients
Too often, a manufacturer will list a
multi-component ingredient by its common
or usual name without breaking out the
parts in parenthesis behind it. Important
-- and not common to many other countries
-- is that this also applies to standardized
foods, such as chocolate, yogurt, cheese.
2. Foreign Product Name
Having a foreign product name is enough
to trigger FDA’s dual-labeling declarations,
which means that all mandatory information
must be declared in English and all
languages appearing on the label.
3. Missing or Incomplete Product
Description
Sometimes the marketing and regulatory
characteristics of labels are at odds with
each other. In order to sell a product, it
needs an interesting brand name. That is
where the product description must come
in and explain what the product is. Too
often, foreign manufacturers feel this is not
necessary since the principle display panel
(PDP) “explains it” and problems at the
time of import occur.
4. Net Weight Declaration
Too often this is either missing, in the
wrong spot or incorrectly declared. The
24
“Net Weight” declaration must be in the
lower third of the PDP with no intervening
material. This means that even though
it is a beautiful and colorful label, none
of its parts may interfere or disturb this
declaration. For example, if the images of a
soup bowl and napkin are on the PDP, they
may not be near the net weight statement.
Also important to remember is that U.S.
and metric measure should be declare, for
example: NET WT ____ OZ (____g).
5. Type Size Requirements Not Met
The FDA requires a minimum type size
of 1/16 inch (1.6 mm). Naturally, the type
size should increase as the area available
for labeling on the package increases.
Too often, the type size is so small that it
cannot be read.
8. Claims
Very often a company will ask if a
claim, such as “GMO free,” is permitted
on its label. The answer would be “No.”
The FDA has put a lot of time and effort
into the Food Labeling Guide on its website
(www.fda.gov/Food/Guidance
ComplianceRegulatoryInformation/
GuidanceDocuments/FoodLabelingNutrition/
FoodLabelingGuide/default.htm). It poses
the most commonly asked questions and
gives easy-to-understand answers with links
to the appropriate regulations. Of particular
interest are the charts provided for the
various Implied and Nutrient Content claims.
I often encourage foreign manufacturers
to stay away from health claims, since the
requirements in their home country are
often very different than those of the U.S.
Many of the statements these manufacturers
want to use would place the product in a
wavering possibility of being a drug.
9. Manufacturer Name and Address
Fancy Food Show
6. “Export Packages”
Labels that have 10 to 15 languages
on them are often impossible to read
and definitely do not meet the minimum
type size regulation, let alone any of the
other FDA regulations. No matter how
successful this packaging is in other parts
of the world, you can expect a detention
if the FDA samples your product and
sees a large number of languages. It is
best to keep labels to a maximum of three
languages in order to also be able to fulfill
all other labeling requirements.
7. Nutrition Facts
This is a problem for companies on
many fronts: They do not stick to the FDA
formats and abbreviations, including the
rules on type size and making sure that the
declaration has a “frame.” Also, foreign
manufacturers work with 100g instead of
the FDA-established “reference amounts”
and then ignore or are not aware of the
rounding rules that must be observed for the
various nutrients. It only takes one of these
mistakes to violate the Nutrition Labeling
and Education Act of 1990 (NLEA).
Foreign manufacturers are used to
declaring their names and addresses, but
what they do not often know is that they
must also include their countries for the
FDA, even though the country-of-origin
statement for Customs is right there.
The reason: Two separate agencies are
requiring a country declaration.
10. Bioterrorism Act/FSMA
The manufacturer and importer must have
a food facility registration number. As a result
of FSMA, this will have to be “updated”
in the last quarter of round years, starting
in October of this year. The FDA plans to
add additional questions, such as requesting
permission to inspect a facility. Responding
in the negative to this question could result in
the company being banned from exporting to
the U.S. The FDA is also looking at placing
further questions on the new registration in
order to help the agency determine whether a
firm is “high risk” or “non-high risk.” Details
on this are still pending.
Conclusion
The FDA has stated time and again that
it is not out to disrupt trade, but its greatest
responsibility is the safety of the food
supply. Complying with these requirements
is not as bad as it seems. Prepare yourself
and ask questions. There are many experts
willing to help you through the process. It is
worth every moment and dollar you put into it!
Wishing you successful selling in the
U.S!
© Informa Ltd 2012

June 22, 2012

Transcription

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