Food Regulatory Update January - February 2014

FMFUSDAF
Food Regulatory Update
January - February
2014
by
Melvin S. Drozen
Eve Pelonis
Fatima Aslam
KELLER AND HECKMAN LLP
1001 G Street, N.W.
Washington, D.C. 20001
Phone: (202) 434-4222
Fax: (202) 434-4646
[email protected]
I.
U.S. ACTIVITIES ............................................................................................................... 1
A.
FDA ............................................................................................................................. 1
FDA Declines Requests to Determine If GM Products Can Be Labeled “Natural” ... 1
FDA Issues Guidance Documents on Beverages and Dietary Supplements ............... 1
FDA Introduces Adverse Event Reporting System for Dietary Supplements............. 2
FDA Establishes List of Eligible Milk Product Firms for China Exports................... 2
Congress Releases FDA’s Budget for Fiscal Year 2014 ............................................. 2
Jensen Brothers Face Fines and Probation for Listeria Outbreak ............................... 3
FDA Plans to Restructure Its Office of Regulatory Affairs ........................................ 3
FDA Urged to Eliminate the Use of Artificial Caramel Coloring............................... 4
B.
FSMA .......................................................................................................................... 5
FDA Publishes Proposed Rule on Sanitary Food Transportation ............................... 5
FDA to Hold Third Public Meeting for Proposed Rule on Intentional
Adulteration.......................................................................................................... 5
FDA Unveils Approach to Defining “High-Risk” Foods under FSMA...................... 5
FDA Extends Comment Deadline for Animal Feed Proposal..................................... 6
C.
OSHA .......................................................................................................................... 6
OSHA Publishes Interim Final Rule on Whistleblowers ............................................ 6
D.
USDA .......................................................................................................................... 7
New FSIS Directive Provides Guidance on Approving Generic Labels ..................... 7
FNS Relinquishes Limits on Grains and Meat Servings in the National Lunch
Program ................................................................................................................ 7
Spending Bill Reveals USDA’s Budget for FY 2014 ................................................. 8
NOP Releases Final Guidance for Handlers of Unpacked Organic Products ............. 8
Congresses Approves Five-Year Farm Bill................................................................. 9
8 Million Pound Beef Recall Prompts OIG Investigation ........................................... 9
E.
General......................................................................................................................... 9
General Mills’ Cheerios Are Now GMO-Free ............................................................ 9
PrimusLabs Files Motion to Dismiss Jensen Farms’ Complaint............................... 10
AAFCO Issues New Civil Penalties for State Feed Law Violators........................... 10
GMA Countersuit Seeks to Dismiss GM Labeling Lawsuit ..................................... 10
New Hampshire Senate Pushes GM Labeling Initiative to Next Year’s Ballot ........ 11
Lawsuit against POM Wonderful Moves to U.S. Supreme Court............................. 11
II.
INTERNATIONAL NEWS.............................................................................................. 12
A.
Europe........................................................................................................................ 12
EFSA Exposure Assessment Determines BPA Poses Low Health Risk................... 12
EU Initiates Second Round of Tests for Horsemeat in Beef Products ...................... 12
FOOD REGULATORY UPDATE
I. U.S. ACTIVITIES
A. FDA
FDA Declines Requests to Determine If GM Products Can Be Labeled “Natural”
On January 6, FDA declined a request from three judges who had asked the Agency to make
a determination on whether products made with genetically modified (GM) ingredients can
be labeled as “natural.” The response letter was sent by FDA’s Assistant Commissioner for
Policy, Leslie Kux, who noted that if the Agency were to make the determination, it would
have to work with USDA and other stakeholders. She added that the task would be
complicated and require the consideration of relevant science, consumer preferences,
perceptions and beliefs, food production technologies in addition to genetic engineering, food
processing methods, and First Amendment considerations. Kux also noted that, even if the
Agencies initiated those actions, there is no guarantee that they would ultimately “revoke,
amend, add to the current policy, or develop any definition at all.” She concluded by
explaining that FDA currently has more pressing issues to address and is focusing its limited
resources to handle those “priority food public health and safety matters, including
developing regulations mandated by the Food Safety Modernization Act (FSMA).” See:
http://articles.law360.s3.amazonaws.com/0499000/499387/Letter.pdf.
FDA Issues Guidance Documents on Beverages and Dietary Supplements
On January 14, FDA published a new guidance document, Guidance for Industry:
Distinguishing Liquid Dietary Supplements from Beverages, to help dietary supplement and
beverage manufacturers and distributors determine whether a product in liquid form is
properly classified as a dietary supplement or as a beverage. FDA has observed an increase
in the marketing of liquid products that include a wide variety of ingredients and intended
uses. Therefore, the Agency issued this guidance to remind manufacturers of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) requirements regarding their respective
ingredients and labeling to avoid misbranding. FDA also released Guidance for Industry:
Considerations Regarding Substances Added to Foods, Including Beverages and Dietary
Supplements after noticing the increasing number of beverages and conventional foods that
contain novel substances, such as botanical ingredients or extracts, some of which may be
unapproved food additives or substances being added in levels beyond traditional use levels.
This guidance is intended to remind manufacturers and distributors of the requirements for
conventional foods under the FD&C Act, and to remind dietary supplement manufacturers
and distributors that the same requirements apply to certain substances that are added to
dietary supplements, specifically, those that are not dietary ingredients as defined in Section
201(ff)(1) of the FD&C Act. See: Distinguishing Liquid Dietary Supplements from
Beverages: 79 Fed. Reg. 2451 (Jan. 14, 2014) at https://federalregister.gov/a/2014-00498
and, http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation
/dietarysupplements/ucm381189.htm.
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Considerations Regarding Substances Added to Foods: 79 Fed. Reg. 2450 (Jan. 14, 2014) at
https://federalregister.gov/a/2014-00500 and,
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/I
ngredientsAdditivesGRASPackaging/ucm381315.htm.
FDA Introduces Adverse Event Reporting System for Dietary Supplements
On January 13, FDA activated a web-based system that allows dietary supplement
manufacturers to submit mandatory adverse event reports (AERs) about their products
online. Previously, only voluntary reports could be reported online. The reporting
requirements for submitting both voluntary and mandatory reports electronically have not
changed. FDA will continue to accept mailed forms as an alternative to submitting them
online. See: http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm381317.htm.
FDA Establishes List of Eligible Milk Product Firms for China Exports
FDA released a new guidance document, Guidance for Industry: Establishing and
Maintaining a List of U.S. Milk Product Manufacturers/Processors with Interest in Exporting
to China, which covers China’s General Administration for Quality Supervision and
Inspection and Quarantine’s (AQSIQ’s) newly added requirements for exporting milk
products and commodities and explains FDA’s criteria for maintaining a list of suitable U.S.
firms that are eligible to export such products to China. One of the requirements is that U.S.
firms must register with the Certification and Accreditation Administration of China (CNCA)
if they wish to export those products to China. Additionally, the companies must have had
an inspection by FDA within three years with a satisfactory result and either be listed on the
Interstate Milk Shippers list or the USDA Dairy Plans Surveyed and Approved for USDA
Grading Service list. However, U.S. firms that have been the subject of pending judicial
action (e.g., such as an injunction or seizure) or a pending administration action (e.g., a
warning letter) will not be accepted on FDA’s list of suitable exporters. Firms that no longer
qualify or do not respond to the Agency’s request for updated information will be deleted
from the list. An updated list will be published online every two years and sent to the CNCA
on a quarterly basis. FDA has been accepting applications as of January 7, 2014, and expects
to publish the first list of eligible exporters online and send it to CNCA by April 30, 2014.
See: http://www.fda.gov/food/guidanceregulation/guidancedocumentsregulatoryinformation
/importsexports/ucm378777.htm.
Congress Releases FDA’s Budget for Fiscal Year 2014
Congress has approved the government spending bill for fiscal year (FY) 2014 (H.R. 3547).
The bill will provide FDA with $2.552 billion in discretionary funding, a $91 million
increase from FY 2013 funding, with an additional $1.79 billion expected from user fees.
The bill will also provide FDA an additional $85 million to restore the loss of funds due to
the Office of Management and Budget’s (OMB) sequester of the Agency’s user fees. The
funding provided to FDA’s centers will be distributed as follows: $900.2 million for the
Center for Food Safety and Applied Nutrition (CFSAN); $173.2 million for the Center for
Veterinary Medicine (CVM) and its field staff; and $62.4 million for the National Center for
Toxicological Research (NCTR). In a report released with the funding bill, Congress advised
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that FDA should provide adequate training for the inspectors charged with enforcing the
FSMA regulations. It also advised that the Agency’s revisions to the preventive controls rule
should be “economically feasible to the Agency and the industry.” See:
http://www.appropriations.senate.gov/news.cfm?method=news.view&id=5aa8e660-f52e4074-945f-9618eb963ae9.
Jensen Brothers Face Fines and Probation for Listeria Outbreak
The owners of the Granada, Colorado-based Jensen Farms, Eric and Ryan Jensen, were
sentenced by a federal court judge for charges involving the shipment of adulterated
cantaloupe linked to the Listeria outbreak in August 2011, which resulted in 33 deaths and
147 hospitalizations. Last October, the Jensen’s pleaded guilty to misdemeanor counts for
introducing adulterated food into interstate commerce but did not plead guilty to the criminal
charges. They faced a maximum sentence of up to one year in prison and a fine of up to
$250,000 per count. On January 28, Magistrate Judge Michael E. Hagerty sentenced Eric
Jensen to five years of probation (with the first six months as in-home detention), 100 hours
of community service, and a $150,000 fine. Ryan Jensen received the same sentence, along
with a requirement to complete a substance abuse program. See:
http://www.usatoday.com/story/news/nation/2014/01/28/sentencing-of-colorado-cantaloupefarmers/4958671/.
FDA Plans to Restructure Its Office of Regulatory Affairs
FDA Commissioner Margaret Hamburg announced several upcoming changes in the Office
of Regulatory Affairs (ORA) that are intended to move the Agency towards verticallyintegrated regulatory programs and elevate the role of center directors in the development of
compliance plans. ORA will take the lead on execution of both compliance policies and
enforcement strategies in partnership and consultation with the Centers/Directorates.
Additionally, inspectors, laboratories and the compliance force will become more specialized
in order for the Agency to keep up with technical advancements and the diversity of
manufacturing sectors. Hamburg explained that ORA and other FDA Centers will need to
develop training curricula, certification processes, performance assessments, and other
components to create a more specialized workforce. ORA will also work with the Centers to
“establish new import strategies by commodity/product and will conduct import operations
consistent with Center/Directorate risk-informed compliance strategies and policies.” The
Centers will be required to provide specific prioritizations for imports through the annual
work plan based on the public health and compliance-risk. ORA and other FDA Centers will
“de-layer management and review levels, where feasible, in order to better enable FDA to
take timely and appropriate action, avoid duplication, improve efficiency, and enhance
accountability.” The Agency’s top officials plan to develop a strategy for moving from the
current geographically-based model to a program-based or functional model by June 1, 2014,
and the Center directors and other top officials will establish action plans with a list of
specifics for meeting the new compliance vision by October 1, 2014.
See: http://bit.ly/1btsqpA.
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FDA Urged to Eliminate the Use of Artificial Caramel Coloring
Recent reports are raising concern regarding the presence of 4-Methylimidazole (4-MEI), a
possible carcinogen, in artificial caramel colorings, in cola beverages. In a paper published
in January, Consumer Reports found that the level of 4-MEI in cola beverages sold by
PepsiCo and Goya in California exceeded the state’s Proposition 65 No Significant Risk
Level (NSRL) of 29 micrograms per day. In particular, Consumer Reports’ data revealed
that regular Pepsi purchased in California last December contained an average of
29.1 micrograms of 4-MEI per can; Diet Pepsi purchased between April and September 2013
contained an average of 30.5 micrograms per can; Pepsi One purchased between April and
September 2013 contained an average of 43.5 micrograms per can; and Pepsi One cans
purchased in December 2013 contained an average of 39.5 micrograms per can. The Malta
Goya products purchased in California between April and September 2013 contained an
average of 352.5 micrograms of 4-MEI per 12-ounce serving. Two lawsuits recently filed
against PepsiCo and Goya Foods reference the Consumer Reports data to support its
complaint alleging the companies mislead consumers by not declaring the presence of 4-MEI
in their products and deceptively omitting that the soft drinks contain dangerous levels of the
chemical that exposes consumers to cancer. Both lawsuits, filed in the U.S. District Court for
the Southern District of California on behalf of Thamar Santisteban Cortina, are seeking class
action status for consumers who purchased cola products made with artificial colorings
Caramel III and Caramel IV. The plaintiffs are seeking damages and attorney’s fees, an
order enjoining Pepsi and Goya from selling the products referenced in the lawsuit as long as
they continue to contain 4-MEI in amounts exceeding the Proposition 65 threshold, and an
order compelling both companies to conduct a “corrective advertising campaign.”
Additionally, on January 23, Consumers Union, which publishes Consumer Reports, filed a
citizen’s petition asking FDA to either eliminate the use of artificial caramel colorings or
ensure the colorings do not contain 4-MEI. The petition specifically requests the following
changes to the regulations for caramel colorings: (1) prohibit the use of ammonium
compounds in making caramel colorings; (2) include the limits for the amounts of 4-MEI
present in such colorings to the regulations in 21 CFR § 73.85 (b); (3) certify each batch of
caramel coloring produced with ammonium compounds as containing no detectable or
negligible levels of 4-MEI; and (4) distinguish among the four classes of caramel coloring
and require distinct labels on products containing those colorings. See:
Consumer Reports Paper:
http://www.consumerreports.org/cro/news/2014/01/caramel-color-the-health-risk-that-maybe-in-your-soda/index.htm;
Consumer Union Press Release:
http://consumersunion.org/news/consumer-reports-tests-show-consumers-unnecessarilyexposed-to-potential-cancer-risk-in-many-soft-drinks/; and,
Lawsuits:
http://www.law360.com/articles/503857/suits-say-pepsi-goya-masked-caramel-color-content.
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B. FSMA
FDA Publishes Proposed Rule on Sanitary Food Transportation
On January 31, FDA released a proposed rule to address the sanitary transportation of human
and animal food, which is intended to implement the Sanitary Food Transportation Act of
2005, as required by Section 111 of the FDA Food Safety Modernization Act (FSMA). With
some exceptions, the rule would apply to shippers, receivers, and carriers who transport food
in the U.S. by motor or rail vehicle, and would be applicable to activities that are intrastate in
character. This would include shippers who ship food by sea or air, if the shipper arranges for
the transfer of the intact container in the U.S. onto a motor vehicle or rail vehicle for
transportation in U.S. commerce for consumption or distribution in the U.S. The proposed
rule would establish requirements for vehicles and transportation equipment, transportation
operations, information exchange, training, record keeping, and the procedures by which the
FDA will waive any of these requirements. FDA has determined that waivers would be
appropriate for: (1) shippers, carriers, and receivers who hold valid permits and are inspected
under the National Conference on Interstate Milk Shipments (NCIMS) Grade “A” Milk
Safety Program, only when engaged in transportation operations involving Grade A milk and
milk products; and (2) food establishments holding valid permits, only when engaged in
transportation operations as receivers, or as shippers and carriers in operations in which food
is relinquished to consumers after transportation from the establishment. See: 79 Fed. Reg.
7006 (Feb. 5, 2014) at http://www.gpo.gov/fdsys/pkg/FR-2014-02-05/pdf/2014-02188.pdf;
Summary:
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383763.htm#summary; and,
Fact Sheet:
http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM383764.pdf.
FDA to Hold Third Public Meeting for Proposed Rule on Intentional Adulteration
FDA will hold its third and last public meeting to discuss its proposed rule on focused
mitigation strategies to protect food against intentional adulteration. The proposed rule,
which is required by the Food Safety Modernization Act (FSMA), would require domestic
and foreign food facilities obligated to register under the Federal Food Drug, and Cosmetic
Act to address hazards that may be intentionally introduced by acts of terrorism. The
meeting is scheduled for March 13, 2014, from 8:30 a.m. to 2:30 p.m. at the Sheraton Park
Hotel in Anaheim, California. The meeting is designed to solicit oral stakeholder and other
public comments on the proposed rule, inform the public about the rulemaking process
(including how to submit comments, data and other information to the rulemaking docket),
and respond to questions about the proposed rule. See:
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm383595.htm.
FDA Unveils Approach to Defining “High-Risk” Foods under FSMA
FDA published its criteria for identifying foods that would be subjected to the additional
recordkeeping requirements in Section 204 of the Food Safety Modernization Act (FSMA).
FDA was required to create a list of the “high risk foods” by January 4, 2012. The Agency is
now making progress on the long overdue task with the release of a draft document on its
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approach towards designating high risk foods, which will be based on the following factors:
outbreak frequency, illness occurrence, severity of illness, the likelihood of microbial or
chemical contamination, potential for the food to support pathogen growth, food
consumption patterns, the probability of contamination, and steps taken during
manufacturing to reduce contamination. It is further noted that health and economic impacts,
such as disability-adjusted life year (DALY), quality-adjusted life year (QALY), and cost of
illness (COI) would be taken into consideration as well. FDA is planning to complete its
rulemaking by taking the following steps: (1) use the statutory factors to be considered for
defining criteria and scoring; (2) to the extent applicable, develop a comprehensive list of
food-hazard pairs representative of FDA-regulated foods or food categories; (3) collect data
relevant to the scoring criteria for the food-hazard pairs identified; (4) execute the draft risk
model to determine risk scored for the food-hazard pairs; (5) determine the total risk score
for a food or food category in which multiple hazards occur; (6) validate risk ranking results
from the draft semi-quantitative risk model by using FDA-iRISK; and (7) use the total risk
score for foods or food categories to create a preliminary list of high risk foods, which is not
anticipated to be a food hazard list, but rather a food list. Foods would be classified using
FDA’s Reportable Food Registry (RFR) commodity definitions, which include fewer than 30
broad categories. FDA will publish the list of high-risk foods before or concurrently with a
proposed rule under Section 204 of FSMA. See: 79 Fed. Reg. 6596 (Feb. 4, 2014) at
https://federalregister.gov/a/2014-02255 and,
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm383648.htm.
FDA Extends Comment Deadline for Animal Feed Proposal
FDA extended the comment period for its proposed rule on the current good manufacturing
practices (cGMPs) and hazard analysis and risk-based preventive controls for food for
animals (Section 103 of the Food Safety Modernization Act (FSMA)) from January 31 to
March 31, 2014, in response to the feed industry’s request for additional time to review the
proposal. Several feed industry members pointed out that they have never been subjected to
cGMP requirements and would need extra time to analyze and prepare meaningful comments
to address all of the issues raised by proposed rule. See: 79 Fed. Reg. 6111 (Feb. 3, 2014) at
https://federalregister.gov/a/2014-02111.
C. OSHA
OSHA Publishes Interim Final Rule on Whistleblowers
On February 13, the Occupational Safety and Health Administration (OSHA) published an
interim final rule on the Agency’s handling of whistleblower complaints under Section 402
of the Food Safety Modernization Act (FSMA), which protects employees who are engaged
in the manufacture, processing, packing, transporting, distribution, reception, holding or
importation of food from retaliation when they raise food safety issues with their employer.
The rule includes: procedures for filing employee complaints with OSHA (which must be
filed either verbally or in written form within 180 days of the alleged retaliation); procedures
for OSHA investigative actions; a requirement that OSHA issue a written reasonable cause
determination within 60 days; procedures for appealing OSHA determinations to an
Administrative Law Judge (ALJ) for a hearing with de novo review; ALJ hearing procedures;
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the process for seeking review of ALJ decisions by the Administrative Review Board (ARB);
and judicial review of the resulting final decision. Under the new rule, the whistleblower
does not need to show that the conduct complained of constituted an actual violation of the
law. The complaining employees are protected from retaliatory actions as long as they have
a reasonable belief, which is defined in the regulation as a subjective, good-faith belief, or an
objectively reasonable belief, that the complained-of conduct violates the Federal Food,
Drug, and Cosmetic Act (FD&C Act). Comments on the interim final rule are due by April
14, 2014. See: 79 Fed. Reg. 8619 (Feb. 13, 2014) at http://www.gpo.gov/fdsys/pkg/FR2014-02-13/html/2014-03164.htm and,
https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=NEWS_RELEASES&
p_id=25641.
D. USDA
New FSIS Directive Provides Guidance on Approving Generic Labels
On January 6, USDA’s Food Safety and Inspection Service’s (FSIS) published Directive
7221.1 to provide inspectors with additional guidance on the new requirements for the
generic labels of meat poultry products submitted through the Public Health Information
System (PHIS) for approval. The new requirements, issued under a final rule published in
November 2013, expanded the circumstances in which meat and poultry product
manufacturers can have their product label generically approved. The new Directive advises
that inspectors must verify that establishments have received necessary label approvals and
that they are in compliance with general labeling requirements through the PHIS. It also
reminds inspectors that any label that does not contain all required components can be
contested, and products carrying that label can be held from shipments. See:
http://www.fsis.usda.gov/wps/wcm/connect/9a2ebc76-2d43-4658-841af810b1f65f04/7221.1.pdf?MOD=AJPERES.
FNS Relinquishes Limits on Grains and Meat Servings in the National Lunch Program
USDA’s Food and Nutrition Service (FNS) permanently waived the requirements regarding
the weekly maximum limits on grains and meat served in school meals, which were
established by the National School Lunch and Breakfast programs in an interim final rule that
went into effect on July 1, 2012. FNS lifted all of the restrictions in response to concerns
expressed by state partners and school food authorities (SFAs), who reported that the limits
presented in the interim final rule posed significant operational challenges, particularly for
SFAs with multiple menu offerings and multiple serving lines during meal service. Another
concern was that some popular products were not yet readily available from suppliers in the
wide variety of serving sizes required in the interim final rule, and students were not
selecting new items that were in compliance with the regulation. FNS noted that so far the
changes have provided a new flexibility for measuring compliance and have had a
meaningful impact on the certification process by making it less complicated for SFAs to be
certified as compliant with the new meal plan. See: 79 Fed. Reg. 325 (Jan. 3, 2014) at
http://www.gpo.gov/fdsys/pkg/FR-2014-01-03/html/2013-31433.htm.
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Spending Bill Reveals USDA’s Budget for FY 2014
The consolidated spending bill Congress approved for fiscal year (FY) 2014 (H.R. 3547) will
provide USDA with a total of $20.9 billion in discretionary funding, a $350 million increase
from FY 2013. The funding provided to each sub-agency will be distributed as follows:
$1.01 billion for the Food Safety and Inspection Service (FSIS); $2.6 billion for agricultural
research programs including the Agricultural Research Service (ARS) and the National
Institute of Food and Agriculture (NIFA); $821.7 million for the Animal and Plant Health
Inspection Service (APHIS); and $1.5 billion for the Farm Service Agency (FSA). The bill
will provide additional funding for various other initiatives and programs under USDA,
which includes: $2.4 billion for rural development; $6.7 billion for the Women Infants and
Children (WIC) program; $19.3 billion for child nutrition programs; $82.2 million for the
Supplemental Nutrition Assistance Program (SNAP); and $1.47 billion for international food
programs, particularly “Food for Peace” grants, also known as the P.L. 480 – Title II
program. In an accompanying report, Congress stated that it does not approve of USDA’s
continued implementation, enforcement, and the associated spending related to the
mandatory country of original labeling (COOL) regulation for certain meat products during
the pending World Trade Organization (WTO) dispute with Canada and Mexico. It also
mentioned that the Federal Trade Commission (FTC) cannot use the appropriated funds to
take further action on its draft report, Interagency Working Group on Food Marketed to
Children; Preliminary Proposed Nutrition Principles in Guide Industry Self-Regulatory
Efforts, unless it complies with Executive Order No. 13563, which requires a cost-benefit
analysis of the report. See:
http://www.appropriations.senate.gov/news.cfm?method=news.view&id=5aa8e660-f52e4074-945f-9618eb963ae9.
NOP Releases Final Guidance for Handlers of Unpacked Organic Products
USDA’s National Organic Program (NOP) published a final guidance document on
certification requirements for handlers of unpackaged organic products. The draft guidance,
released in 2012, was originally issued in response to the National Organic Standards
Board’s October 2010 request to clarify the bulk handling policy. The draft guidance had
received many comments from industry members who expressed concern with the
certification requirements for transporters of bulk organic products, such as milk tankers or
railcars transporting grain. In its final guidance document, NOP clarifies the issue,
explaining that transporters of bulk organic products do not meet the definition of the term
“handler” under USDA organic regulations and therefore, are not subjected to the
certification requirements for handlers of unpackaged organic products. NOP also mentions
that the certified organic operation (COO) is responsible for those products and must prevent
commingling and contamination of the organic products during transportation. The COO is
also responsible for maintain records for auditing and traceability purposes. Additional
responsibilities of COOs with respect to transportation practices are listed in the Organic
System Plan (OSP). See: 79 Fed. Reg. 3301 (Jan. 21, 2014) at
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5106110 and,
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5106108.
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Congresses Approves Five-Year Farm Bill
Congress approved the long-awaited Farm Bill, formally known as the Agricultural Act of
2014, which will serve as the standard policy for U.S. agricultural practices for the next five
years. The total spending budget for implementing the legislation will be $956.4 billion over
the next 10 years, which is a $16.6 billion decrease from the current spending level. The bill
will provide funding for a specialty crop research initiative, increased funding for the
National Organic Program (NOP), a new fruit and vegetable incentive grant program for
Supplemental Nutrition Assistance Program (SNAP) recipients, and a pest and disease
prevention program. According to the agriculture committee staff, the total amount of
savings from the bill is expected to be $23 billion due to several spending cuts, such as the
$8.6 billion cut to the food-stamp program. Several industry members, such as the National
Cattlemen’s Beef Association (NCBA), were disappointed an amendment that would have
repealed mandatory country of origin labeling (COOL) for meat and poultry products did not
survive the bill, while others, such as the National Farmers Union (NFU), were pleased that
the legislation did not include any changes for the COOL regulations. An amendment
sponsored by Representative Steve King (R-Iowa), referred to as the King Amendment, was
also left out of the final bill. It would have prohibited states from excluding agricultural
products from other states being sold within their borders if the items were not produced in
compliance with state-based regulations. On the other hand, an amendment that survived the
bill requires FDA to conduct additional economic and scientific analyses of the produce
safety rule under the Food Safety Modernization Act (FSMA) to address the widespread
concern that the rules will be too costly to farmers. Additionally, the legislation reauthorized
USDA to oversee the catfish inspection program by removing it from FDA jurisdiction. See:
http://www.usda.gov/wps/portal/usda/usdahome?navid=farmbill.
8 Million Pound Beef Recall Prompts OIG Investigation
On February 10, USDA’s Food Safety and Inspection Service (FSIS) announced a recall of
8.7 million pounds of beef products from the Rancho Feeding Corporation located in
Petaluma, California. The recalled products were produced between January 1, 2013 and
January 7, 2014, and distributed to retailers in California, Florida, Illinois, Oregon, Texas,
and Washington. The products were recalled after FSIS found that Rancho had processed
“diseased” animals for a year “without the benefit or full benefit of federal inspection.”
There have been no reported illnesses linked to the recalled products to date. FSIS directed
an immediate and thorough examination of the practices, procedures and management of
Rancho’s plant, which is currently shut down. USDA’s Office of the Inspector General
(OIG) is currently conducting an investigation of the facility to obtain further details on the
adulterated beef products. See: http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-andpublic-health-alerts/recall-case-archive/archive/2014/recall-013-2014-release.
E. General
General Mills’ Cheerios Are Now GMO-Free
General Mills announced that its original brand of Cheerios breakfast cereals no longer
contains genetically modified (GM) ingredients. The Cheerios sold in the U.S. are now made
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with non-GM cornstarch, non-GM sugar, and the cereal boxes are labeled “not made with
genetically modified ingredients.” General Mills clarified that its decision to make the
product GM-free was in response to consumer demand, and “never about the pressure.”
See: http://www.cheerios.com/en/Articles/cheerios-and-gmos#.UwulahAVHTo.
PrimusLabs Files Motion to Dismiss Jensen Farms’ Complaint
PrimusLabs filed a motion to dismiss a lawsuit alleging the company is partly responsible for
the 2011 Listeria outbreak FDA linked to cantaloupes supplied by Jensen Farms. The
complaint, filed by Jensen Farms, charges PrimusLabs with negligence, negligent hire,
negligent misrepresentation, and breach of contract and deceptive trade practices. Jensen
alleges the company’s subcontractor, Bio Food Safety (BFS), failed to identify certain
unsanitary conditions of Jensen’s packinghouses during an audit conducted shortly before the
outbreak, which were later identified by FDA as the likely cause of contamination.
However, Primus’ motion noted that BFS did not have a duty to conduct a deeper evaluation
of the packinghouse because Jensen did not ask for one. It further argued that the likely
cause of the outbreak is the production, distribution, and sale of contaminated cantaloupes,
which was outside Primus’ control. On the issue of negligent hire, Primus claimed that
Jensen did not show the audit was conducted in a negligent manner or that Primus knew the
auditor, BFS, would perform the duties negligently. Primus concluded that Jensen cannot
support the charges as the “[c]omplaint fails to allege…that Primus made a ‘material
representation’ or that the Jensen’s justifiably relied on the packinghouse audit in
determining that its cantaloupes were Listeria free.” See:
http://www.law360.com/dockets/documents/52c2dd5f69ce420257000074 and,
http://www.law360.com/dockets/download/52c2dd5f69ce420257000074?doc_url=https%3A
%2F%2Fecf.cod.uscourts.gov%2Fdoc1%2F03914988541&label=Case+Filing.
AAFCO Issues New Civil Penalties for State Feed Law Violators
The Association of American Feed Control Officials (AAFCO) approved a new policy that
allows animal feed control officials who bring enforcement actions against violators of state
feed laws to charge civil penalties. Under the new policy, states can collect the civil
penalties on a per violation, per day basis. However, states will have to adopt the language
regarding civil penalties into their feed laws before they begin collecting the penalties. The
language is featured in AAFCO’s model bill for 2014. Members of AAFCO include state,
federal, and international regulatory officials who are responsible for enforcing state laws on
feed and pet food. AAFCO updates its guidelines, including a model feed bill, each year for
states to consider adopting for regulation of feed products. See:
http://www.aafco.org/Publications/PublicationListing.aspx.
GMA Countersuit Seeks to Dismiss GM Labeling Lawsuit
On January 3, the Grocery Manufacturers Association (GMA) filed a countersuit against
Washington State Attorney General Bob Ferguson contesting the state’s bid to penalize
GMA for bundling millions of dollars from its members to fund opposition towards a bill (I522) that would require labeling of products made with genetically modified (GM)
ingredients. According to Ferguson’s complaint filed on October 16, 2013, GMA allegedly
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failed to comply with the state’s requirements to declare itself as a political action committee
(PAC) after soliciting and collecting approximately $7.2 million from its members to fund
opposition to I-522. The requirement imposes a series of disclosure and reporting
requirements including releasing the names of the donors. (Two days after Ferguson’s
complaint was filed, GMA registered as a PAC and disclosed the contributors of the
funding.) GMA’s countersuit states that the state’s campaign finance laws and Ferguson’s
enforcement of those laws violate its civil and constitutional rights, and that the Attorney
General’s interpretation of the definition of a PAC imposes substantial burdens on groups
like GMA and its members. It also argues that the state’s reporting requirements are
unconstitutional, as the law “facially discriminates against out-of-state citizens.” GMA has
requested that the court dismisses the Attorney General’s lawsuit and declares the disclosure
requirements unconstitutional. See:
http://www.atg.wa.gov/pressrelease.aspx?id=31741#.Uwz3ihAVHTo.
New Hampshire Senate Pushes GM Labeling Initiative to Next Year’s Ballot
On January 22, New Hampshire’s House of Representatives voted to reject a bill (H.B. 660)
that would have required labeling of foods that contain genetically modified (GM)
ingredients. New Hampshire was the third state, after Connecticut and Maine, to introduce a
bill that would require GM labeling. If enacted, New Hampshire’s GM labeling initiative
would have declared any human or animal food offered for retail sale on or after July 1, 2014
misbranded if such food was, or may have been, entirely or partially produced with genetic
engineering and such fact was not disclosed. Also, in the case of any processed food, the bill
would have required the package offered for retail sale to “include the clear and conspicuous
words ‘Partially Produced with Genetic Engineering’ or ‘May be Partially Produced with
Genetic Engineering.’” However, the initiative was defeated by several opponents of GM
labeling who raised concerns about the costs and potential legal challenges brought by food
manufacturers and biotech seed companies. Opponents also argued there was no evidence of
a health threat associated with consuming products that contain GM ingredients and that
states cannot regulate the interstate commerce of food. See:
http://www.law360.com/articles/503316/genetically-modified-food-labeling-bill-fails-in-nhhouse.
Lawsuit against POM Wonderful Moves to U.S. Supreme Court
The lawsuit between POM Wonderful and Coca-Cola Co. will be heard by the U.S. Supreme
Court after justices agreed to consider the issue over different labeling laws. POM had
originally filed the complaint against Coca-Cola in 2008 based on the Lanham Act, alleging
that Minute Maid (owned by Coca-Cola) misled consumers with the labeling, marketing, and
advertising campaign for Pomegranate Blueberry Flavored Blend of 5 Juices, which was
built around the pomegranate and blueberry ingredients even though the main ingredients of
the product were apple and grape juice. POM unsuccessfully attempted to appeal a lower
court’s decision that ruled in favor of Coca-Cola, which found that the product name was
expressly authorized by FDA. POM’s appeal was denied in August 2012. The Obama
administration recently filed a brief urging the U.S. Supreme Court to determine whether the
court of appeals erred in holding that a private party cannot bring a Lanham Act claim
challenging a product label regulated under the Federal Food, Drug, and Cosmetic Act. The
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Supreme Court decision on the issue is expected by this summer. See:
http://supremecourtreview.com/case/12-761.
II. INTERNATIONAL NEWS
A. Europe
EFSA Exposure Assessment Determines BPA Poses Low Health Risk
On January 17, the European Food Safety Authority (EFSA) announced a public consultation
on its draft exposure assessment titled, Draft Scientific Opinion on the Risks to Public Health
Related to the Presence of Bisphenol A (BPA) in Foodstuffs. In conducting the assessment,
an expert panel reviewed more than 450 studies and applied a weight of evidence approach,
which found that the health risk for all population groups, including fetuses, infants, young
children and adults is low. EFSA noted that the combined oral and non-oral exposure to
BPA in humans is three to five times lower than the estimated safe level of exposure
proposed by the Authority tolerable daily intake (TDI). According to EFSA TDI should be
lowered from its current level of 50 µg/kg bw/ day (or 0.05 mg/kg/bw/day) to 5 µg/kg
bw/day (0.005 mg/kg/bw/day) and be set on a temporary basis. The draft opinion confirmed
diet as the main source of exposure to BPA in all population groups. The non-food sources
identified include thermal paper used in grocery store receipts. Interested parties may
comment on EFSA opinion by March 13, 2014. See:
http://www.efsa.europa.eu/en/press/news/140117.htm
EU Initiates Second Round of Tests for Horsemeat in Beef Products
The European Union (EU) began its second round of DNA-tests for horsemeat in beef
products in 28 Member States. The European Commission established the control plan after
last year’s fraud scandal that revealed beef products sold in several British and Irish
supermarkets were found to contain undeclared horse meat. Member-state experts endorsed
a recommendation by the Commission for a coordinated plan for DNA tests at a meeting of
the EU’s Standing Committee on the Food Chain. This is the second time the Commission
has coordinated a control plan to find out if horsemeat is still being added to products labeled
as beef. The Commission noted the first round of testing in 2013 revealed that approximately
4.6% of the products sampled contained undeclared horsemeat. See:
http://europa.eu/rapid/press-release_MEX-14-0214_en.htm.
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