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IEG Policy Food & Agriculture Outlook 2019
Anticipate every shift.
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IEG Policy
Contents
5 Introduction
US FOOD POLICY ❱
7 Produce safety likely to be priority #1 for FSMA in 2019
11 US agencies strike deal on regulating cell-based meat,
but thorny issues remain for 2019
15 Regulatory Outlook: US ready to revamp GE crop and animal rules
EUROPEAN FOOD LAW ❱
19 An odyssey of food labels challenge EU single market
23 A taxing year for food and drink
27 Tide continues to turn against palm oil as Europe’s protest intensifies
EUROPEAN AGRICULTURE POLICY ❱
29 CAP reform plans stalled by 2019 political timetable
33 Drought, agriculture and climate change: an end-of-year review
37 Supply chain fairness: Europe edges closer to new rules
39 Agri-food sector to remain on a knife-edge as Brexit drama
continues to unfold
US AGRICULTURE POLICY ❱
43 Battle over USMCA shifts to Congress in 2019, swift approval
not assured
47 Host of issues ahead for the US biofuel industry
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Introduction
2018 was an exceptional year for food and agriculture policy
and regulation globally, and 2019 promises more of the same.
In the US, a series of food safety scares, in 5% fall in the overall budget for the policy Even the CAP reform
particular an outbreak of E. coli in romaine to contend with as a direct result of losing
lettuce, put the Produce Safety rule under the net contribution made by the British.
proposals for 2021-27
the spotlight again and the focus is set to could not escape from
intensify in 2019 as regulators start Some of the proposed changes to the farm the looming prospect of
inspecting produce farms for the first time policy have disappointed some and have
under the Food Safety Modernization Act. been described as more ‘evolutionary’ than
the UK’s departure from
‘revolutionary’ – but given the headwinds the bloc, with a 5% fall
It was also a benchmark year for lab-grown that have buffeted the agriculture sector in in the overall budget
meat with decisions being made in regard recent years, and the lack of political will to
to the oversight of the sector, while there change things too much, it was difficult to
for the policy
were also regulatory changes for the imagine another outcome.
biotech industry.
EU farmers suffered a difficult summer with
President Donald Trump was of course at the drought impacting crops and livestock but
centre of things, kicking off a trade war with in better news for them, things moved
China that saw the Asian country apply import forward with legislation to tackle Unfair
tariffs on agricultural goods such as soybeans, Trading Practises in the supply chain.
and a renegotiation of NAFTA that may
open up new opportunities for US farmers. Finally, the EU Food Law agenda was as
busy as ever with developments in food
In Europe, Brexit was at the heart of things labelling policy and actions to introduce
for the EU agriculture sector, with uncertainty sugar taxes and restrict imports of palm oil.
over a future trading relationship and (at
the time of writing) left questions over the The following pages take a look at the past
withdrawal agreement still hanging in the air. year in review and cast an eye ahead at
what is to come in 2019.
Even the CAP reform proposals for 2021-27
could not escape from the looming prospect Adam Sharpe, Publishing Director: IEG Vu
of the UK’s departure from the bloc, with a & IEG Policy, Agribusiness Intelligence
IEG Policy | Food & Agriculture Outlook 2019 / 5
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US FOOD POLICY ❱
Produce safety likely to be
priority #1 for FSMA in 2019
Lettuce outbreaks in 2018 to shape FDA’s
enforcement of produce safety rule
by Joan Murphy
The spotlight on the Produce Safety rule is likely to intensify For the third time in
in 2019 as regulators start inspecting produce farms for the a little over a year, the
first time and FDA tries to navigate the difficult job of writing leafy greens industry
workable water provisions under the Food Safety Modernization battled intense public
Act (FSMA). scrutiny in the wake
A lot happened in produce safety in 2018. farms in January 2018 to comply with of E. coli illnesses
With the produce industry under the gun to FSMA, except for the agricultural water
comply with FSMA, 2018 became the year provisions that were put on hold. In
of romaine lettuce outbreaks that not only January 2019, farms that qualify as small
added urgency to FDA efforts to rewrite businesses will be next in line.
water standards but also revealed a gaping
need for better traceability. For the third time in a little over a year, the
leafy greens industry battled intense
The 2015 Produce Safety rule, one of seven public scrutiny in the wake of E. coli
foundational rules established under the illnesses. During the latest outbreak, FDA
2011 FSMA, sets science-based standards informed US consumers not to eat any
for the safe growing, harvesting, packing romaine lettuce, a devastating blow to
and holding of fruits and vegetables. growers, then announced an industry-
wide tagging scheme that would identify
Referred to by FDA as a “heavy lift” from romaine lettuce by harvest date and
the start, FSMA required large produce growing region as a way to return safe
IEG Policy | Food & Agriculture Outlook 2019 / 7
(FSVP) deadlines this year and there were
concerns raised importers would not
be prepared.
Under FSMA, food importers need to verify
they are significantly minimizing or
preventing risks and producing food in a
manner that provides the same level of
public health protection as required for
US producers.
Breen said that so far, the most common
finding during FSVP inspections is that
importers do not have FSVP plans.
“It has to be worrisome to FDA that all the
products to the market and calm industry as the agency considers next steps efforts they have made still haven’t
consumer fears. in drafting new water standards. FDA also is succeeded in moving importers, albeit a
drafting a rule that will revise the definition newly regulated population, into greater
Inspections have yet to start on big farms, of “farm” and spell out when packing compliance,” he said.
however. FDA Commissioner Scott Gottlieb houses, terminal markets, and other
announced in 2017 that regulatory entities conducting farm-related activities He also predicted the increase in the
inspections would be pushed back to are required to comply with the preventive number of FSVP inspections may become a
spring 2019 to allow more education in the controls or produce rules. higher priority in 2019, particularly as the
field and give FDA more time to set up number of foreign plant inspections drops
technical assistance, train inspectors and When FDA asked the romaine industry to off – a likelihood when budgetary
write guidance documents. follow voluntary standards on labeling constraints put a squeeze on foreign food
romaine lettuce to help consumers know inspections in 2019.
This will give states, who will take the lead which products are safe, it served as a
in FSMA produce inspections, and growers reminder FDA did not move ahead with VQIP launches
more time to conduct voluntary On-Farm another FSMA requirement – traceability. 2019 will be the first full year for the
Readiness Reviews to bone up on the FSMA directed FDA to recommend a Voluntary Qualified Import Program (VQIP),
requirements before regulatory inspections product tracking system. the fast lane FSMA created for top-notch
begin, Gottlieb said. importers to be rewarded with speedier
“If you look back a lot of what FSMA itself port clearances.
Consumer groups, however, have complained had given FDA authority to do … still,
about the delay in inspections during the maybe it isn’t quite implemented yet,” FDA originally expected to have the VQIP
latest bout of leafy greens outbreaks. said Benjamin Miller, senior director of portal in place earlier, but the launch was
food safety for The Acheson Group (TAG). delayed when it took extra time to accredit
So, 2019 will be the year for the first “I think we’re seeing some of the certification bodies. In October, FDA
regulatory inspections on the farm that will consequences of that.” opened the VQIP application portal to allow
be almost exclusively conducted by state extra time for importers who want to take
officials, with FDA providing training, advice But that may be changing. At least one advantage of the program next year.
and scientific support, said Charles Breen, a retailer, Walmart, decided to take the issue
former FDA official who advises on FSMA for of traceability into its own hands by Food companies fiercely advocated for the
EAS Consulting. requiring, as of Sept. 30, 2019, all leafy fee-based program under FSMA to help
greens suppliers to use blockchain to trace qualified exporters move their food
The lettuce outbreak put added pressure on products in seconds, not days. And products into the United States with
FDA to set sound agricultural water Walmart’s blockchain architect, Frank greater speed and predictability, and
standards after the first attempt was Yiannas, has just taken the job as chief without fear of unexpected delays at the
soundly rejected as too complicated and regulator at FDA, another key development point of entry.
too difficult to implement, sending FDA in 2018 that may raise the profile of food
back to the drawing board. The water traceability at the agency and prod the But the question remains: Will importers
standards are a key lever in preventing industry as it becomes more digital to find VQIP worth the steep fees?
contaminated produce, which is why FDA embrace blockchain.
set microbial quality standards for “I don’t think FDA knows,” Breen said.
agricultural water, including irrigation water FSVP inspections
that comes in contact with produce. Produce safety is not the only game in Another problem is the program relies on
town for food companies. Importers user fees instead of congressional
A final rule due out soon will officially were required to meet the first round of appropriations. “If too few importers sign
extend the compliance deadline for Foreign Supplier Verification Program up, there won’t be the money to provide
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enough support to make VQIP attractive to For the animal feed industry, inspections,
enough other importers to sustain it.” originally slated to begin in January, were
pushed back to this fall for large businesses
New inspection model subject to regulatory inspections for the
to be piloted Current Good Manufacturing Practices
In 2019, FDA plans to tinker with its (CGMPs) and PCs – and for importers whose
preventive control inspections for food foreign suppliers are large facilities.
plants. The agency will be experimenting
with a new two-tiered inspection system The Animal Feed Industry Association
that would allow investigators to check (AFIA) said it was pleased some of the
written supply chain programs and recall deadlines were pushed back, but it had also
plans at a firm’s corporate location before asked for a delay in enforcing the supply
heading to individual plants. chain requirements.
The agency asked in September for at Intentional adulteration rule
least five companies to test the new raises questions
approach, which was pitched by food The 800-pound gorilla may be FDA’s
companies early in the FSMA rule-writing enforcement of the FSMA International
process. FDA also sees the potential payoff Adulteration (IA) rule. FDA is required to
for reducing inspection times in facilities, begin enforcing the rule after July 26, 2019,
improving public health and increasing and it’s got the industry on edge.
outreach time between industry and
FDA staff. Concerned about food tampering,
Congress included steps to mitigate wide-
Under the Tier 1 component of the pilot, scale harm from IA in the 2011 law. Since
FDA plans to conduct an announced then, the food industry has raised
Preventive Controls for Human Food concerns about the potential price tag of
inspection at a central location where complying with the IA rule. Congress
investigators will assess a firm’s written included language in the latest FY 2019
supply-chain programs (subpart G of part appropriations bill that reminds FDA to
117) and recall plans (21 CFR 117.139). take into account food defense practices
already in place when helping them to
With that information in hand, FDA comply with the new program.
investigators would move to the
unannounced, Tier 2 inspections at the Earlier this year, Stephen Ostroff, FDA’s
firm’s plants where they will check for then-deputy commissioner for foods and
compliance, with supply chain and recall veterinary medicine, acknowledged FDA
plans reviewed at the offsite location during has had “an ongoing dialogue with
the Tier 1 inspection. This move is designed industry regarding the requirements and
to save time during the facility inspections. the associated costs.”
Preventive controls FDA released the first draft guide in June to
enforcement continues ready the largest facilities that must meet
FDA is likely to undertake a modest FSMA requirements in the summer of 2019.
increase in enforcement of both human Another installment is due out in early
and animal food Preventive Control (PC) 2019. Small facilities follow in July 2020,
regulations in 2019, Breen predicted. while very small facilities (less than $10
Whatever enforcement does happen, million in sales over a three-year period)
warning letters or stronger measures are will only need to prove by 2021 they meet
likely to be a result in the event of an the exemption of the IA rule.
immediate health hazard, he said.
Even with the rolling deadlines coming into
David Acheson, the founder of TAG, said he force for FSMA in 2019, FDA will need to do
also expects more enforcement of PC rules more with less, Breen predicted.
as FDA moves from education to regulation.
The agency will need to conduct FSMA
FDA officials reported in June that education, guidance, technical assistance
preventive control inspections were taking and training while cutting back in other
roughly twice as long as traditional ones as lower risk areas. Guidance documents and
investigators conduct environmental training will continue to have priority over
sampling and check food safety plans. the coming year, he said.
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US FOOD POLICY ❱
US agencies strike deal
on regulating cell-based
meat, but thorny issues
remain for 2019
by Margarita Raycheva
While plenty of questions remain on how cell-based meat will “2018 was the year
be regulated in the United States, 2018 shaped up to be a when USDA and FDA
“momentous” year for the emerging cultured meat industry. decided they are going
to work together to
Following months of debate and pressure to predict before 2018, because very few
from both conventional and cell-based people were thinking about how cell- ensure that clean meat
meat producers, FDA and USDA have based meat and poultry should be comes to market safely
solved what grew to become the most regulated or labeled, Almy noted. and efficiently”
significant regulatory challenge involving
the new cell-based meat industry – who “Outside companies that are producing Jessica Almy, policy director,
should regulate it. it or organizations like GFI, I don’t Good Food Institute
know that those issues were really a
“2018 was the year when USDA and FDA part of the public discourse,” Almy
decided they are going to work together explained. “So, I think that 2018 has
to ensure that clean meat comes to been really momentous. I’ve heard of it
market safely and efficiently,” Jessica being referred to as sort of the birth of
Almy, policy director at the Good Food cell-based meat because there has
Institute (GFI) told IEG Policy Dec. 4. been so much progress on how cell-
based meat will be regulated in the
Such an outcome would have been hard United States.”
IEG Policy | Food & Agriculture Outlook 2019 / 11USDA, FDA strike joint “There are no technical barriers in this field
regulatory agreement anymore,” suggested Eric Schulze, Memphis
Watched by hundreds, the meeting Meats’ vice president of product and
marked a turning point in the debate, as regulation, in November. “The regulatory
FDA and USDA leaders alluded to working system is what needs to gel and clarify so
on a joint regulatory framework. And in that we can produce safe products, that
November, the two agencies developed a once they are brought to market
broad framework to jointly regulate the consumers will really know what they are
emerging field. getting. We [Memphis Meats] are ready to
go when the regulatory system is.”
Under the agreement, FDA, which already
has experience with cell-culture technology Memphis Meats’ poultry and beef products
and living biosystems, would oversee cell- are expected to reach the market by
based meat products until they reach the 2021, while the Netherlands-based Mosa
cell harvest stage, including cell collection, Meat says it plans to start selling cell-
cell banks, and cell growth and based hamburgers within the next one or
differentiation. USDA would take over once two years.
the product is developed into tissue and
apply its expertise in overseeing production Cell-based meat industry
and labeling. hopes for guidelines in 2019
Regulatory questions open Though a regulatory framework is now in
rift between agencies While still very preliminary, the framework place, much remains to be done before
Still, establishing a regulatory framework, has been hailed by cell-based meat regulators decide exactly how to oversee
was a painful process that over the past producers for outlining a clear regulatory the novel food sector.
year often pitted the two major US food path for companies, Almy said.
regulators against one another. According to Almy, the biggest step
“The joint statement made it pretty clear forward will come when FDA and USDA
Tension between the agencies started that FDA is going to be the point of entry develop specific guidelines for industry.
mounting in June, when FDA attempted into the regulatory framework, so Secretary of Agriculture Sonny Perdue
to take the lead on cultured meat companies should be consulting with FDA indicated in October that his goal would
regulation and scheduled a meeting for about safety issues before coming to be to release the guidelines in 2019,
stakeholders without including or market,” she said. even though that may be a rather
consulting with USDA. While most cell- ambitious deadline.
cultured companies embraced the idea, This model will apply to cell-based meats
the move worried consumer advocates and poultry, while fish, which traditionally “My expectation … is that the two agencies
and angered many in the conventional falls under FDA jurisdiction, will likely are expecting to come out with guidelines
meat industry, leading some meat groups remain under that agency, Almy noted. for the industry in 2019. So that’s what I
to ask President Trump to put USDA in will be looking forward to next year – to see
charge of the novel food sector. While that issue, as well as many other what those guidelines look like and how
technical questions, have yet to be ironed the two agencies want to interact with
Concerned that potential FDA oversight of out, the joint plan has also appeased the these two companies,” Almy said.
cell-based meats could place conventional traditional meat industry. The National
meat producers at a disadvantage, the Cattlemen’s Beef Association (NCBA) called Work on the guidelines has started, as the
meat industry lobby even pushed the plan a “step in the right direction,” as two agencies have already encouraged
lawmakers to include language in the it places labeling and inspection of cell- stakeholders to comment on priority issues
US House version of the FY 2019 Agriculture based meat production under USDA, and that will likely be addressed in the
Appropriations Bill that would give USDA not FDA jurisdiction. guidelines, Almy noted.
the sole authority to oversee
the emerging sector. But there is still work to do, the group Those include potential hazards and
suggested, particularly in ensuring “that sources of hazards, types and frequency of
As the debate raged and even states real beef producers and consumers are inspections, and effective pre-market
picked a side, the North American Meat protected and treated fairly.” programs that could ensure the safety of
Institute (NAMI) and Memphis Meats products developed through cell culture.
teamed up in pitching a solution to allow Memphis Meats and JUST have also hailed
the agencies to split oversight. the broad idea of joint regulation. Regulators are also trying to determine
what factors to consider for labeling and
The tension did not ease until September The lack of a regulatory framework has whether to establish standards of identity
when the two agencies announced been problematic for the cell-based meat to ensure that product names are
a joint meeting to discuss oversight, sector, because it impedes investment and “truthful, not misleading, and sufficiently
as well as hazards and labeling of cell- holds back companies from scaling up for differentiate cell cultured products from
based products. mass production. traditional products.”
12 / Food & Agriculture Outlook 2019 | IEG Policy www.ieg-policy.comHoping that stakeholder input will help matter, even within the cell-cultured and
them make final decisions, the agencies traditional meat industries.
have extended the comment deadline until
Dec. 26. The United States Cattlemen’s Association
(USCA), for instance, does not want cell-
The task ahead based meat products to be called “meat”
Answering those questions, however, is or “beef,” so in February it petitioned USDA
not going to be simple, suggested Brian to prohibit the use of those terms on cell-
Ronholm, a former USDA deputy based product labels. While the agency has
undersecretary for food safety, who is now yet to respond, both NAMI and NCBA, the
senior director for regulatory policy at largest and oldest national trade
Arent Fox. association for American cattle producers,
oppose the idea, so they’ve joined
There is still much about the cell-based thousands of other stakeholders in asking
meat process that is unknown, so before USDA to reject the petition.
identifying any specific safety risks, USDA
would first have to invest time for studying A similar battle is raging in Missouri, which
cell-based production, Ronholm noted. in August adopted the nation’s first law
restricting the term “meat” only to
And there is also the issue of how solving products that come from slaughtered
questions about cell-cultured meat animals. Backed by Missouri cattle
products would fit into the agencies’ producers, the law has been challenged
larger framework of competing priorities, by a coalition of plant-based food
he noted. advocates who argue that the statute
represents an unconstitutional attempt to
The agencies, therefore, would have to censor their labels.
determine how close these cell-based meat
products are to mass production. The cell-cultured industry itself has yet to
agree on what its products should be
“After that, then the agency can decide called, Almy noted. While industry
the level of agency resources they want to unanimously opposes terms such as
devote to it,” Ronholm said. “If mass “synthetic meat,” “lab-grown meat” or
production is several years away, if it “fake meat,” the idea of using “clean meat”
happens at all, it might make more is not universally accepted and at least one
sense for USDA to allocate resources to producer, Memphis Meats, is pushing for
more immediate needs, such as the more neutral “cell-based meat.”
combatting Salmonella.”
According to Ronholm, that means
Reaching agreed-upon labeling decisions could stretch further
terminology a sticking point into the future.
The labeling of cell-cultured meats and
poultry is also likely to cause headaches for “This might not be one of the first issues
regulators in the coming months. that gets addressed, but it has the
potential of being the most onerous,”
As indicated by questions they posed to Ronholm said. “First, is the decision on
stakeholders, the agencies have already what to label it – cell-cultured meat, lab-
highlighted where they want to start grown meat, etc. This is expected to be a
and are considering issues, such as source of contention, and it likely will be
whether labels for cell-cultured meats and difficult to reach a consensus.”
poultry should specify methods of
production or the source of the animal And, if disagreement lingers, that will raise
cells. There are also questions about how even more questions, which could even
to handle health and safety claims for impact the product’s ability to enter the
such products and how to label products market, he noted.
that contain both cell-cultured and
traditional meat. “That notwithstanding, this easily could
become a product that consumers develop
Answering these questions is likely going to their own identity standard, without any
be an uphill battle because an agreed upon official agency designation,” Ronholm said.
name for cell-cultured meats has already “If so, how will that impact the industry,
been a highly controversial and divisive and how do the agencies manage that?”
www.ieg-policy.com 1314 / Food & Agriculture Outlook 2019 | IEG Policy www.ieg-policy.com
US FOOD POLICY ❱
Regulatory Outlook:
US ready to revamp GE
crop and animal rules
by J.R. Pegg
2019 is poised to be a critical year for agricultural biotechnology “The fundamental
as the Trump administration appears ready to fundamentally basis of those regulations
re-shape the US regulatory regimes for genetically engineered has not changed in 31
crops and animals. years... It’s long overdue”
Revising the federal rules for genetically “The fundamental basis of those Mike Firko, APHIS Deputy Administrator
for Biotechnology Regulatory Services
engineered crops – known as Part 340 – regulations has not changed in 31 years,”
will be a major focus for USDA in 2019 he said. “It’s long overdue.”
and a proposal from the Animal and Plant
Health Inspection Service (APHIS) should APHIS officially launched a new
be ready early in the year, according to a rulemaking to update the GE crop rules
top agency official. in June, asking for stakeholder input
on how the regulatory regime should
“This is our number one strategic initiative,” be revamped.
according to APHIS Deputy Administrator
for Biotechnology Regulatory Services (BRS) Under the existing regulations, APHIS
Mike Firko. considers all new GE plants as “regulated”
until it assesses if the product falls under
APHIS intends to publish a proposal in the their authority and determines if it poses a
first quarter of 2019 to make much- plant pest risk. The agency explains its
needed changes to the Part 340 rule, Firko current approach as “regulate first and
told attendees at a BRS stakeholder analyze later” – one that is focused on the
meeting in November. process of modification, rather than the
IEG Policy | Food & Agriculture Outlook 2019 / 15product. Critics say the process is expensive, we’ve done quite a bit of outreach on that year and several other companies are
restrictive and misguided. since then.” aggressively moving forward with gene
edited crops. Calxyt, the US plant science
But APHIS got only 35 comments on its Although it has been “very difficult to do subsidiary of French genomics company
June notice, Firko said, a figure that could anything with biotech regulations,” Firko Cellectis, is already growing its high-oleic
be a sign of stakeholder fatigue with trying said he is “very confident” that this latest soybeans in the US and its first harvests are
to change the Part 340 rules. APHIS has effort will succeed. expected in 2019.
been calling for reform since 2004 and
issued a formal proposal in 2008 that The new plan will ensure APHIS is clearly Perdue’s interest stretches beyond the
would have expanded the scope of GMOs focused on its limited authority over GE domestic regulation of GE crops and has
under its regulatory regime and revamped crops, Firko explained. directed the agency to lobby other
the permitting system. But that effort countries to follow the US lead and to
stalled and was abandoned in March 2014. “We don’t have any legislation about contest the current European approach to
biotech in particular – our legislation is regulation of new gene editing tools.
The agency subsequently held a series of about plant pests and weeds,” he said. “So
stakeholder meetings and issued a new that’s what our decisions are about.” US ag officials were critical in drafting an
proposal in January 2017 during the final international statement of support for
weeks of the Obama Administration. Gene editing genome editing in agriculture presented to
The new GE crop rules will likely be the World Trade Organization (WTO). So far
The plan called for major changes to the industry-friendly and will no doubt reflect a dozen countries – including Argentina,
rules, notably a new trigger for regulation the Trump administration’s enthusiasm for Brazil, Canada and Australia – have signed
and revisions to enable the APHIS to ag biotech and the USDA’s desire to take a on to the pro-biotech statement. The move
regulate a broader array of GE crops, hands-off approach to regulation of gene is a clear response to the July 2018 ruling
including those made with new gene- edited plants. by the European Court of Justice (ECJ) that
editing technologies. declared gene-edited plants should be
Agriculture Secretary Sonny Perdue has said treated as GMOs and subject to regulations
But the plan was not well received by farm on several occasions that USDA has little by EU member states.
and agriculture groups and was interest in regulating crops that have been
abandoned by the Trump administration in developed with gene editing tools like Perdue said the EU policy puts at risk
late 2017. Critics said it would undermine CRISPR-Cas9 and TALENs – a view the the “great promise” gene editing holds for
the agency’s bid to modernize its department shared under the prior agriculture and could hamper
regulatory process and do little to make it administration. In 2016 USDA declined to international trade.
easier for new biotechnology products to regulate a non-browning mushroom
come to market. engineered using CRISPR and US ag USDA will be reaching out to other countries
interests are bullish on the prospects of in 2019 to caution them about the impact of
“Withdrawing that proposed rule set the gene editing to improve crops. the EU approach and to rally additional
stage for a new level of engagement which support for the WTO statement, according
we could not do as long as we were in Corteva Agriscience is set to introduce its to Paul Spencer, director of new technologies
open rulemaking,” Firko explained. “And strain of CRISPR-edited waxy maize next at USDA’s Foreign Agricultural Service.
16 / Food & Agriculture Outlook 2019 | IEG Policy www.ieg-policy.com“We’re primarily concerned with the trade The issue of FDA’s oversight of animal
elements of this,” Spencer said at the BRS biotechnology animals has also caused
meeting in November. “The implication … is friction with Agriculture Secretary Perdue,
that the European Union’s global policy who has echoed stakeholder concern about
influence could pose a threat to US the FDA’s plan.
agriculture’s ability to adopt and benefit
from these genome editing tools.” Perdue has previously suggested USDA
should take the lead on oversight of GE
The ECJ decision “emboldens the anti- animals and several Republican members
technology groups,” Spencer said. “And of Congress have indicated they might
that’s already prevalent in EU member seek a legislative fix to shift authority
states such as France.” away from FDA.
The administration is committed to In December FDA postponed a live webinar
contesting the idea that new genome that was intended to detail its approach to
editing techniques are akin to GMOs and regulating GE animals – the event has yet
should be regulated as such, Spencer added. to be re-scheduled. The webinar was
announced as part of FDA’s latest action
FAS will be spending considerable effort to plan for regulating biotech – the agency
try and “limit the policy influence that the says it is excited by the potential benefits
ECJ judgment,” he said. from both plant and is keen to promote
development with a “science- and risk-
GE animal guidance based approach” to regulation.
While USDA is keen to aggressively promote
gene editing for crops – and to promote its FDA’s revised animal guidance is expected
hands-off approach to trading partners – to be finalized in 2019, but FDA has
FDA is sending different signals about how not announced a timetable or indicated
it will regulate GE animals. But that doesn’t how concerns raised about the draft might
mean the agency isn’t preparing to act in be addressed.
the coming year.
Promoting Biotech
Draft guidance, released in January 2017 FDA and USDA are working together
by the Obama administration and still on an initiative to educate the public
under review at FDA, calls for the agency to about the benefits of agricultural
continue regulating biotech animals as new biotechnology, a move welcomed by the
animal drugs and to expand its oversight. food and agriculture industries. The two
Currently FDA considers the presence of an agencies have been given some $3 million
rDNA construct from another species as its by Congress for the effort, which directs
trigger for regulation. FDA and USDA to collaborate on
“consumer outreach and education
But the draft guidance moves far beyond regarding agricultural biotechnology” to
that in a bid to bring in CRISPR, TALENs and inform the public of the “environmental,
other gene editing tools by including any nutritional, food safety, economic, and
animal with intentionally altered genomes humanitarian impacts” of GMOs.
to FDA’s new animal drug review and
regulations. The plan has drawn sweeping FDA’s Agricultural Biotechnology
criticism from ag and biotech interests – Education and Outreach Initiative has
critics worry the proposed revisions will strong support from biotech advocates –
needlessly expand the agency’s authority a coalition of more than 60 food and
and undermine efforts to develop and agriculture groups urged lawmakers to
commercialize biotech innovations that authorize the effort because of their
could help producers control diseases, concerns that consumers are being fed
improve food safety, enhance animal misinformation about the safety and
welfare and decrease the environmental benefits of GMOs.
impacts of animal agriculture.
An FDA spokesperson told IEG Policy that
Only one GE food animal – AquaBounty’s the agency plans to launch the initiative in
GE salmon – has been approved by 2019, adding that it is currently
FDA and commercialization of that “conducting formative research that will
product has become ensnared in a dispute help inform the development of our
over labeling. educational materials for the public.”
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EUROPEAN FOOD LAW ❱
An odyssey of food
labels challenge
EU single market
Different origin labels, colour coded
nutrition panels, vegan and vegetarian
logos springing up in EU
by Sara Lewis
The food and drink industry’s ability to trade freely across the On 28 May the European
EU single market is being increasingly challenged by numerous Commission adopted a
different national and industry labelling schemes, despite regulation laying down
the 2011 food information to consumers regulation new rules for mandatory
(FIC – 1169/2011) laying down harmonised rules on nutrition, origin labelling of primary
ingredients and allergen labelling.
ingredients in foods
Origin Labelling the same place as labelled on the final bearing ‘made in...’
One of the areas where labelling has been product. The regulation will apply from labels when they are
hitting the headlines in 2018 and is almost April 1, 2020 to give food business
certain to do so in 2019, is origin labelling. operators time to adapt product labelling
not from the same
to the new requirements. place as labelled on
On 28 May the European Commission the final product
adopted a regulation laying down new The FIC regulation already requires that
rules for mandatory origin labelling of where the origin of a food is given and is
primary ingredients in foods bearing different from the one of its primary
‘made in...’ labels when they are not from ingredient, the origin of the primary
IEG Policy | Food & Agriculture Outlook 2019 / 19on potatoes that member states discussed
with the Commission at a December 7
meeting of the Standing Committee on
Plants, Animals, Food and Feed (PAFF)
general food law section.
In September Spain adopted a dairy origin
labelling law that requires labels to
distinguish between products made in the
country from Spanish milk, or those using
imported milk, even from other member
states. Dairy products also have to give the
origin of the finished food, stating whether
it is Spanish or not.
France kicked off the spate of national
origin labelling laws in 2016, with its pilot
programme that is supposed to run until
December 31 this year. However, France is
now seeking the Commission’s permission
to extend the pilot project until March 31,
2020, a matter that has split member
states down the middle, between those
that have their own origin laws and others
ingredient shall be given or at least consumers’ understanding of the that see them as a trade barrier and threat
indicated as being different to the origin of information related to the origin of foods,” to the EU single market.
the food for example, Italian tomato sauce the spokesperson continued.
with tomatoes from China. The May 28 Moreover, the European Parliament sees
implementing regulation clarifies how the However, in 2019 the Commission is origin labelling as a way to improve
information on the origin of the primary planning to look into how the origin of the compliance of imports with European
ingredient should be displayed on labels. It primary ingredient should be indicated for animal welfare requirements. On October
lists geographical areas that can be used to protected product designations and 25 it adopted a resolution on broiler
indicate the origin of the primary trademarks. The implementing act does chicken welfare that included a call for
ingredient. It also harmonises the not apply to geographical statements mandatory origin labelling on chicken meat
presentation of origin information on the protected under EU legislation or to in the retail, catering and food services.
primary ingredient to ensure that it is easily trademarks that equal an indication
visible and clearly legible. “Some flexibility of origin. Nutrition labelling
is foreseen for food business operators in While the FIC requires foods to carry
order to take into account the various There have been concerns about national nutrition information on the back of pack,
circumstances of food processing, such as origin labelling legislation, notably Italian it leaves front-of-pack labelling (FOP)
multiple or variable supply sources,” a laws covering rice and the durum wheat for largely up to manufacturers, provided it
Commission spokesperson told IEG Policy. pasta, and more recently dairy products, complies with certain rules. As a result,
but the spokesperson told us that “the national or cross-industry schemes have
Nevertheless, despite calls from consumer legal acts adopted by the Italian authorities sprung up such as the colour-coded UK
groups and many MEPs to have mandatory in the area of origin indications for food link Traffic Light scheme and the Italian
origin labelling for all primary ingredients in the application of their provisions to the batteries label.
the EU, the Commission remains staunchly Commission’s implementing act.”
opposed to any more regulation in this area Meanwhile, the food industry has rolled out
so a move in that direction is not on the The Commission sees the implementing act single colour reference intakes, although
cards for 2019. “Voluntary origin labelling as a way to end concerns about national many firms voluntarily use traffic lights. For
combined with the mandatory origin origin laws, with the spokesperson arguing instance in November both Kellogg’s and
labelling regimes already in place for that “it can be expected that the PepsiCo announced they were going to use
specific foods or categories of foods is the implementing act will provide for the traffic light scheme on products sold in
most suitable way forward at the EU level,” harmonised rules applicable also in Italy the UK and Ireland.
the spokesperson told us. and other countries. This should reduce the
need for further resort to national PepsiCo had been one of five companies
“The aim is to ensure that the information provisions regulating origin indication.” that had started trials of a portion-based
on the origin of a food is given in a manner colour coded Evolved Nutrition Label (ENL)
which does not deceive the consumer and However, the implementing act has not in May, which they then suspended on
on the basis of clear criteria that ensure a stemmed the tide of national origin November 20 blaming a lack of standard
level playing field for industry and improve labelling laws, with the latest a Polish bill EU portion sizes.
20 / Food & Agriculture Outlook 2019 | IEG Policy www.ieg-policy.comIn August Belgium adopted the colour- Andriukaitis was not happy with the (ECI) calling for vegan, vegetarian and
coded Nutri-score scheme that proposal and since then the Commission non-vegetarian labels on all foods.
neighbouring France had introduced in has been negotiating with the spirits and
2017. Both countries officially endorse the wine sectors to find a solution. German The ECI ‘Mandatory food labelling Non-
scheme, but its use is voluntary. centre right MEP Renate Sommer, who was Vegetarian / Vegetarian / Vegan’ has a
the lead MEP on the FIC up to its adoption year from the registration date to gather a
The World Health Organisation (WHO) in 2011, has been highly critical of minimum one million signatures from at
Europe region is also recommending the Commission over its decision to let least seven EU member states. If the ECI
government-endorsed policies on the drinks industry handle the end achieves that then the Commission will
interpretative FOP labelling after its Health of the waiver. have three months to respond, explaining
Evidence Network (HEN) report published in formally what it will or will not do on the
October found nutrition labels a key tool in The Commission will go into 2019 still issue and why.
promoting healthy diets. The report found working on this issue under increasing
government-endorsed labels were more pressure from MEPs, and member states for Even without the ECI, the outgoing
effective than commercial ones. EU action in this area. Sommer is not alone Commission had planned to work on the
in criticising the Commission over its issue in 2019. The ECI will keep up the
The Commission intends to publish a report handling of the issue and demanding an pressure on the Commission to act.
analysing all the different voluntary end to the labelling waiver for alcoholic
schemes in place across the EU in early drinks, Croatian Socialist Biljana Borzan also Moreover, this is another area of labelling
2019 (or possibly at the very end of 2018). launched a stinging attack on the law, where member states are starting to
The report on ‘additional forms of Commission in November and six member adopt national laws in the absence of EU
expression/presentation’ is required under states were highly critical in a Standing regulations. In April France adopted a new
the FIC’s Article 35(5) and needs to look at Committee meeting last April. law banning producers from labelling
their effect on the internal market. plant-based products with meat- and
Crucially, the report should conclude on the As with origin labelling, member states dairy-related names.
advisability of further harmonisation. impatient with the lack of EU action, are
starting to take matters into their own hands, The French law is based in part on the June
Alcohol labelling with national alcohol laws. On October 17, Irish 2017 TofuTown ruling in the European
The FIC waived drinks containing over President Michael D. Higgins signed into law a Court of Justice, which concluded that
1.2% alcohol by volume (ABV) from ground-breaking law on alcohol that notably vegan products cannot be labelled as ‘milk,’
ingredients and nutrition labelling requires cancer and general health warning ‘cheese’ or ‘cream’ even if the products
requirements but gave the Commission a labels on bottles. In the run up to the Irish clearly state that they do not contain
December 13, 2014 deadline for a report bill’s adoption drinks producers from other animal products.
on whether the exemption was still countries, notably over the border in Northern
justified. The report, when it appeared Ireland, expressed concern about the effect The European Parliament elections and the
more than two years overdue on March the labelling rules would have on trade. approval process for the new college of the
13, 2017, concluded that alcoholic drinks Commission that will take office in the
should be subject to both nutrition and Vegan and autumn, is likely to spur the EU executive to
ingredients labelling requirements. Rather vegetarian labelling at least promise action on key labelling
than proposing an amendment to the FIC, While the FIC tasked the Commission with issues where MEPs have seen the outgoing
ending the waiver, EU Health and Food producing an implementing act laying college as dragging its feet. A series of
Safety Commissioner Vytenis Andriukaitis down EU rules for voluntary vegan and hearings where MEPs subject Commissioner
gave industry a year to develop a self- vegetarian labelling, it does not set a nominees to tough questioning, followed
regulatory proposal containing a common deadline for doing so, resulting in the issue by votes, with Parliament able to reject
scheme covering beer, cider, spirits being sidelined. nominees, is likely to focus the minds of
and wine. the incoming college.
However, others are pushing for progress
When the scheme was unveiled on March at EU level, both from the animal welfare Brexit is certain to dominate the
12, it contained four separate annexes side, with people wanting vegan and headlines in 2019 and in case the UK
outlining how each sector was going to vegetarian foods easy to recognise, and crashes out of the EU without an
offer consumers nutrition and ingredients from the meat and dairy side, fighting agreement – a so-called ‘hard Brexit’ –
information. While the beer and cider against use of terms such as ‘vegan turkey the British Department of Environment,
annexes more or less applied the FIC, the slices’ or ‘soya milk’. Food and Rural Affairs (Defra) in
spirits and wine annexes both proposed September published a guidance
to offer consumers the information not This is an issue that will continue to make document “Producing and labelling food
on a bottle label but online through apps headlines in 2019, especially with if there’s no Brexit deal.” The guidance
and websites. Moreover, both favoured European elections focusing politicians’ sets out how labelling of food will be
offering that information per glass rather minds on issues that the public cares affected in case of a hard Brexit on March
than per 100 millilitres as the beer and about. Moreover, on November 12 the 29. Significantly, current EU rules would
cider sectors had proposed and as is Commission registered an EU-wide mega- be rolled over into UK law under the
required under the FIC. petition, a European Citizens’ Initiative Withdrawal Act.
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EUROPEAN FOOD LAW ❱
A taxing year for
food and drink
by Peter Rixon
Several European countries saw the introduction of, or an Drinks companies are
increase in, sugary drink taxes this year. Peter Rixon looks into reducing the sugar
these fiscal developments of the past 12 months and how content of their drinks, as
taxation could further develop in 2019. the Government wants
The UK soft drinks tax came into force – to the consumer. That industry acted
them to, to avoid passing
in April this year and is arguably proving on reformulation was probably necessary on costs – and too much
a success. as a study by Nielson pointed out that sugar – to the consumer
shopping habits were not affected by the
Between April 2018 and the end of October UK sugar tax.
2018, the tax raised £154 million (€173m)
and is on target to raise the expected In France, a similar effect has been
£240m annual revenue. observed this year. The French tax was
actually introduced in 2013 but was then
Admittedly, this is a revised target. The increased in 2017, coming into effective
government had expected to raise £520m on July 1st 2018, as part of the
in the first year, but this was downgraded government’s 2018 Social Security Bill.
to £240m when companies started
reformulating their products. Olivier Veran, the French MP who
spearheaded the tax increase, said
This, however, has proven that the tax companies were already reformulating
has been to some degree effective. Drinks drinks by the middle of the year, with
companies are reducing the sugar Seven Up and Fanta cutting 30% of its
content of their drinks, as the sugar content and some Schweppes and
Government wants them to, to avoid Lipton Ice Tea drinks reducing sugar
passing on costs – and too much sugar content by 40%.
IEG Policy | Food & Agriculture Outlook 2019 / 23Tax in Norway leads to the example of the UK, France, Norway and towards taxation. A study published in the
growth in border sales Ireland in implementing fiscal measures to medical journal, The Lancet, claimed that
Things panned out differently for Norway reduce sugar consumption. taxes on sugar, as well as tobacco and
this year, with its sugar tax system causing alcohol, would help poor households the
considerable upset. As of January 1st, Eastern neighbour, Lithuania, took a most as the resulting price increases would
2018, the Norwegian sugar tax was different approach, however, announcing in lead them to make healthier choices. This
increased by 83%, whilst a fee on soft in February this year that it had opted flew against the industry argument that
drinks and non-alcoholic beverages against bringing in a tax, deciding instead such taxes would harm low-income
increased by 43.3%. to seek cooperative partnerships with the households the most.
food industry to reduce sugar, as well as
This led to heavy criticism from politicians salt and fat in foods. What does 2019 hold?
and industry who realised that the tax was From the UK experience, it seems that the
leading to stronger growth in Swedish sales Germany’s lack of a sugar tax came to the sugar tax is here to stay and can be
as people crossed borders to shop for forefront when it was revealed that the expected to spread to more countries.
cheaper drinks. Germans are Europe’s biggest consumers of
soft drinks. Germany, however, has started The measure offers governments a source of
By August, the Norwegian Brewery and to focus more on measures to improve revenue, is consistent with genuine efforts to
Beverage Association was calling for the the nation’s diet so future proposal could reduce non-communicable diseases among
sugar tax and the soft drinks tax increases still be round the corner. populations, particularly among children, and
to be reversed. The Norwegian government industry has proven capable of not only
proposed that a differentiation of the levies Mixed opinions on taxes incorporating the costs incurred by a new tax,
should be investigated instead. at global meetings but also has proven capable of responding
During the year, global political voices were to the stated aim of the tax, namely by
“The tax increases were introduced in a either firmly in favour of fiscal solutions to reducing the amount of sugar in drinks.
hurry, without impact assessments, and it’s health problems or strategically keeping
a serious situation when the government quiet about them. Should reformulation continue and, as is
doesn’t do anything about this when we envisaged, reduce the corresponding
see an explosive increase in border trade,” In May, the health ministers from the 53 yearly revenue from the tax, then each
Petter Haas Brubakk of the Confederation of member states of the Commonwealth country that imposes the tax could
Norwegian Industry’s (NHO) Food and endorsed a proposal for a 20% tax on potentially expect to see a natural phase-
Beverage complained. sugar sweetened drinks. out at some point. However, this is only in
cases where the stated aim is sugar
By September, Sweden was confirming The measure was one of a number of reduction for health improvement.
the increase in sales, particularly alcohol, proposals at the ministerial summit to tackle
due to the Norwegian sugar tax policy. non-communicable diseases (NCDs), which Also, existing taxes might not go away at
Alcohol sales were rising because people affects about 400 million people across the all but simply be increased, as in the case
were naturally buying beer and spirits at member countries spread throughout Africa, of France and Norway.
the same time as buying the cheaper America, Asia and Europe.
chocolate and sugary drinks during their France has had a sugar tax since 2013 and
cross-border shopping trips. However, an international global the MP who helped introduce it, and
declaration that went before a United spearheaded an increase that came into
Although the UK shares a border with Nations meeting in September to address effect earlier this year, has also gone on
Ireland, there were no corresponding the obesity crisis was criticised for not record to talk about potentially increasing it
problems with cross-border shopping in the mentioning sugary drink taxes. NGOs still further.
way Norway experienced with Sweden. This suspected that the desire for governments
was because Ireland introduced a to work in partnership with industry was Like colour coded labelling on food
comparable sugary drinks tax, just a month responsible for the omission. packaging, once other member states see a
after the UK. successful model being used in one or two
On the academic side, a number of studies European countries, others are likely to
The Republic’s tax came into force on May were published this year that added or follow. And parts of the European
1st after the European Commission said the detracted credence to the value of using a Commission will only likely be encouraging
levy was not illegal state aid. sugar tax to improve health outcomes. the use of such taxation, with Commissioner
Andriukaitis already expressing his support
Romania pushes the tax One study at the beginning of the year for taxes to curb junk food.
agenda, Lithuania eases off suggested that sugar taxes could drive up
To the east, Romania’s interest in taxing alcohol consumption whilst another, from the In addition to this, counterparts in the US
soft drinks picked up pace in May when New Zealand Ministry of Health, concluded have been battling over so-called “soda
draft legislation for a tax was debated by that evidence showing the sugar taxes could taxes” for some year and, as our Informa
the country’s parliament. improve people’s health was “weak”. colleagues in Washington point out in this
podcast, the sugar tax debate over there
The bill stated that Romania should follow However, some studies were positive will not be going away anytime soon either.
24 / Food & Agriculture Outlook 2019 | IEG Policy www.ieg-policy.comYou can also read
