• In response to the Mexican Council of the Consumer Products Industry’s (“ConMéxico”) request for the postponement of Official Mexican Standard NOM-051 (“NOM-051”), Mexican authorities have stated that food and beverage companies may use provisional stickers between October 1, 2020 and March 31, 2021, which will help companies gradually comply with NOM-051.  NOM-051 sets forth a frontal labeling system for prepackaged food and non-alcoholic beverages and informs consumers when products contain high calories, added sugars, saturated fats, sodium, and caffeine.  NOM-051 will come into effect on October 1, 2020.
  • NOM-051 was published in the Diario Oficial de la Federación (Mexico’s equivalent of the Federal Register) on March 27, 2020.  NOM-051 requires manufacturers to place octagonal warning symbols in consumer products that state “Excess Calories,” “Excess Saturated Fat,” “Excess Sugars,” and “Contains Caffeine – Avoid in Children.”  NOM-051 also prohibits the use of characters, drawings, celebrities, gifts, offers, toys, or contests on food packaging.
  • By way of background, on April 28, 2020, the Mexican Council of the Consumer Products Industry (“ConMéxico”), which represents more than 40 major food and beverage producers, urged the Mexican government to postpone the effective date of NOM-051 to remove the additional pressure for the food industry in the midst of COVID-19.  In a virtual conference, Jaime Zabludovsky, president of ConMéxico, urged the government to postpone NOM-051, which will require the relabeling of more than 800,000 products that will require the assistance of nutritionists, food engineers, designers, among others who are not working at their full capacity due to the pandemic.
  • The use of provisional stickers to comply with the octagonal warning requirement will give companies more time so that they do not have to print labels for all of their products before October 2020.  Moreover, companies will be able to place provisional stickers on packaging that they already have in stock to lessen the impact.   We will continue to monitor any developments.
  • On October 11, Mexico’s lower legislative house passed a bill that would require manufacturers to place front-of-pack (FOP) warning labels on food high in sugar, sodium, or saturated fat.  The bill was published in the Diario Oficial de la Federación (Mexico’s equivalent of the Federal Register) and consists of a draft amendment to the General Labelling Specifications for Prepackaged Foods and Non-Alcoholic Beverages-Commercial and Health Information.
  • Mexico’s current FOP labeling provides information on the quantities of and percent daily values for saturated fat, total fat, total sugars, sodium, and calories in foods.  The proposed amendments would require manufacturers to place an octagonal warning symbol, stating “Excess Calories,” “Excess Saturated Fat,” “Excess Sugars,” and “Contains Caffeine – Avoid in Children.”  While FOP labeling is increasingly common in Central and South American countries, a unique provision of the Mexico bill is that it would also include a warning for foods containing artificial sweeteners, stating “Contains Sweeteners – Avoid in Children.”
  • Those interested in commenting on the draft amendment have 60 calendar-days to submit comments. The bill will now go to the Senate, where it is expected to pass, and then to President Andres Manuel Lopez Obrador, who has expressed support for the bill.
  • The Animal and Plant Health Inspection Service (APHIS) of the U.S. Department of Agriculture (USDA) has regulatory authority over both the import and export of livestock products.  In the import context, APHIS works to ensure that products entering the U.S. meet the Agency’s entry requirements to exclude pests and diseases.
  • In July 2014, USDA published a proposed rule (79 FR 43974) that would have recognized Mexico as a low-risk classical swine fever (CSF) region. Since the rule was published, the World Organization for Animal Health recognized Mexico as CSF-free.  As a result, Mexico’s government requested that APHIS suspend its rulemaking and instead continue evaluating Mexico’s CSF status.  APHIS reopened its evaluation and conducted a site visit in 2015. Based on the 2015 site visit report, along with updated surveillance data and additional information submitted by Mexico’s government, APHIS determined that current conditions support CSF-free recognition for all of Mexico.
  • On August 8, 2017, APHIS published a Notice (82 FR 37043) which proposes to recognize Mexico as free of classical swine fever (CSF).  In announcing the publication of this Notice, APHIS also noted that it will withdraw the 2014 proposed rule that would have recognized Mexico as a low-risk CSF region. Recognizing Mexico as CSF-free could potentially create new opportunities for Mexican pork products in the U.S. market.
  • APHIS will be accepting comments on the Notice for 60 days (or until October 10, 2017) prior to making a final determination on Mexico’s CSF status which will ultimately be published in the Federal Register.
  • On March 26, the USDA responded to two petitions that requested FSIS amend the Agency’s Food Standards and Labeling Policy Book to provide that any beef product labeled as “Made in the USA,” “Product of the USA,” “USA Beef,” or in any similar manner be derived from cattle that have been born, raised, and slaughtered in the US. The two petitions were submitted by the Organization for Competitive Markets (OCM) and the American Grassfed Association (AGA) on June 17, 2018, and the United States Cattlemen’s Association (USCA) on October 23, 2019. The response letters for OCM/AGA can be found here and here for USCA.
  • The petitions alleged that since the repeal of country of origin labeling (COOL) requirements in 2015, there has been no official definition of US beef, nor any specific “Made in USA” labeling requirements for beef products that are so labeled. Petitioners argued that the lack of a clear definition of what constitutes “Made in USA” or “Product of USA” or other similar designations leads to consumer confusion.
  • As a reminder, in 2013, the USDA implemented COOL rules, requiring meat labels to indicate where animals were born, raised, and slaughtered.  Meatpacking and livestock commodity groups in the U.S., Canada, and Mexico challenged the COOL requirements via appeal to the World Trade Organization (WTO) and a lawsuit filed in the U.S. (alleging that the requirements infringe First Amendment rights).  The controversy surrounding mandatory COOL rules for beef products ultimately culminated in: (1) a WTO ruling that the COOL requirements violate U.S. trade obligations to Canada and Mexico and (2) Congress repealing COOL as of December 21, 2015.
  • In response to the two petitions, FSIS concluded that “its current labeling policy, which permits meat and poultry products that were derived from animals that may have been born, raised and slaughtered in another country but processed in the United States to be labeled as ‘Product of USA,’ may be causing confusion in the marketplace, particularly with respect to certain imported meat products.” Thus, FSIS decided to initiate a rulemaking to define the conditions under which the labeling of meat products would be permitted to bear voluntary statements that indicate US as the product origin. As indicated in the response letters, FSIS intends to propose that such labeling be limited to meat products derived from livestock that were slaughtered and processed in the US. The policy will focus on where the product is made (i.e., slaughtered and processed) without regard to where the animal was born and raised, meaning that cattle born and raised outside of the US, but slaughtered and processed in the US would be able to bear a “Made in the USA” label.
  • The federal government has taken a supporting role as state and local governments and private companies institute an evolving patchwork of responses to the COVID-19 pandemic.  On March 19, 2020, the Cybersecurity and Infrastructure Security Agency (CISA), operating under the Homeland Security Act of 2002, issued guidance and an accompanying list of “Essential Critical Infrastructure Workers.”  CISA’s list is intended to promote the ability of essential workers to continue to work during periods of community restriction, access management, social distancing, and closure orders or directives.
  • CISA identifies Food & Agriculture as a critical industry and describes essential workers in this industry as follows:
    • Workers supporting groceries, pharmacies and other retail that sells food and beverage products
    • Restaurant carry-out and quick serve food operations – Carry-out and delivery food employees
    • Food manufacturer employees and their supplier employees—to include those employed in food processing (packers, meat processing, cheese plants, milk plants, produce, etc.) facilities; livestock, poultry, seafood slaughter facilities; pet and animal feed processing facilities; human food facilities producing by-products for animal food; beverage production facilities; and the production of food packaging
    • Farm workers to include those employed in animal food, feed, and ingredient production, packaging, and distribution; manufacturing, packaging, and distribution of veterinary drugs; truck delivery and transport; farm and fishery labor needed to produce our food supply domestically
    • Farm workers and support service workers to include those who field crops; commodity inspection; fuel ethanol facilities; storage facilities; and other agricultural inputs
    • Employees and firms supporting food, feed, and beverage distribution, including warehouse workers, vendor-managed inventory controllers and blockchain managers
    • Workers supporting the sanitation of all food manufacturing processes and operations from wholesale to retail
    • Company cafeterias – in-plant cafeterias used to feed employees
    • Workers in food testing labs in private industries and in institutions of higher education
    • Workers essential for assistance programs and government payments
    • Employees of companies engaged in the production of chemicals, medicines, vaccines, and other substances used by the food and agriculture industry, including pesticides, herbicides, fertilizers, minerals, enrichments, and other agricultural production aids
    • Animal agriculture workers to include those employed in veterinary health; manufacturing and distribution of animal medical materials, animal vaccines, animal drugs, feed ingredients, feed, and bedding, etc.; transportation of live animals, animal medical materials; transportation of deceased animals for disposal; raising of animals for food; animal production operations; slaughter and packing plants and associated regulatory and government workforce
    • Workers who support the manufacture and distribution of forest products, including, but not limited to timber, paper, and other wood products
    • Employees engaged in the manufacture and maintenance of equipment and other infrastructure necessary to agricultural production and distribution
  • The CISA list above identifies food packaging and other examples of products that people may not generally recognize as being regulated by FDA as “food,” such as pet food and animal feed, but it does not explicitly recognize dietary supplements as food.  An industry report indicates that dietary supplement manufactures have urged that plants and their sales channels remain open during the COVID-19 pandemic.  The CISA guidance ultimately leaves the issue for state and local governments to decide, although it suggests a broad interpretation, noting “these identified sectors and workers are not intended to be the authoritative or exhaustive list of critical infrastructure sectors and functions that should continue during the COVID-19 response.”
  • While agriculture workers are explicitly identified on CISA’s list of critical infrastructure workers, it is not clear how other arms of the federal government will support CISA’s efforts.  For example, the Wall Street Journal and others have reported that the State Department has stopped processing visas in Mexico for seasonal workers to enter the U.S.
  • On February 11, 2020, Repres­entative Alan Lowenthal of California and  Senator Tom Udall of New Mexico introduced the “Break Free from Plastic Pollution Act of 2020.” The bill would enact nationwide extended producer responsibility for all packaging materials, minimum-recycled-content mandates for certain products, a national container deposit, single-use plastic product bans, a three-year pause on new virgin plastics production facilities, and more.  The proposed legislation includes a national bottle bill, which would add a 10-cent deposit on all beverage containers, regardless of material type.  Udall and Lowenthal stated that this bill serves as a model for states and local governments to use in crafting their own legislation regardless of whether the proposal is successful in Congress.  Currently, only ten states have a container deposit law or “bottle bill.”  Some of these states are also considering proposed legislation, which would change their existing bottle bills.
  • In California, a senate committee will soon hold hearings on Sen. Bob Wieckowski’s Senate Bill 372 that would pressure beverage manufacturers to help consumers recycle.  Senate Bill 372 would also extend the Bottle Bill provisions to wine and liquor makers.
  • In Michigan, a bipartisan group of lawmakers introduced H.B. 54225425, which would update Michigan’s current bottle bill.  This would be the first update to Michigan’s bottle bill since 1976.  The proposed bill seeks to increase recycling rates and reduce fraud and abuse.  According to the Executive Director of Michigan Recycling Coalition, the legislation would allocate funding to the counties, which could then use it to boost existing or create new municipal recycling programs.  Moreover, H.B. 5424, would create enhanced criminal penalties for a distributor that violated the bottle deposit law with the intent to defraud and cheat.
  • In Massachusetts, H2881 and S452 seeks to include miniature containers that can hold 100 milliliters (specifically miniature liquor bottles) under the state’s existing “bottle bill” law, charging the same 5-cent deposit on their sale as other bottles.  We will continue to monitor any developments.
  • In late December 2019, Mexico’s Chamber of Deputies’ voted in favor of a reform to the Ley de la Propiedad Industrial (“Industrial and Federal Property of Consumer Protection law”), which would make regulations on misleading advertising more stringent.  This prohibition will have an impact on plant-based alternatives that currently use dairy terms, such as “soymilk” or “almond yogurt.”
  • The reform would amend articles 90 and 95 of the Industrial and Federal Property of Consumer Protection law, which would expand what constitutes false or misleading language, including the composition of products.  The president of the Livestock Commission, Eduardo Ron, noted that the draft bill “represents hope for thousands of small, medium, and large milk producers, who everyday face unfair practices in the market.”
  • The next step is for Mexico’s Chamber of Senators to review the amendments to the Industrial and Federal Property of Consumer Protection law.  Ron noted that the law would also apply to other products, like sugar-based syrup products that depict honeybees on their packaging, which confuses and misleads consumers.  We will continue to monitor any developments.
  • On August 26, the FDA issued a letter to all sectors of the papaya industry to take action to prevent future foodborne illness outbreaks. As noted in the letter, since 2011, consumers have been exposed to eight outbreaks caused by Salmonella serotypes linked to imported, fresh papaya. In June of this year, FDA started an investigation into an outbreak of Salmonella Uganda illnesses tied to the consumption of whole, fresh papaya imported from Mexico. While the 2019 outbreak is ongoing, the first seven outbreaks accounted for almost 500 reported cases of illness, more than 100 hospitalizations, and two deaths.
  • In the letter, the FDA stated that it intends to use all the tools and enforcement powers available to the Agency to further strengthen safeguards and prevent contaminated papayas from being imported into the U.S. Such tools include education, outreach, training, enforcement, and research activities.  However, the FDA noted that more must be done within the industry to protect customers and meet legal obligations, such as the requirements set forth under the Produce Safety Rule and the Foreign Supplier Verification Program. Thus, the Agency set forth a number of action items for the papaya industry to implement:
    • Assess the factors that make crops vulnerable to contamination. If a foodborne pathogen is identified in the crop or growing environment, a root cause analysis should be performed to determine the likely source of contamination. Procedures and practices that minimize that risk must be implemented.
    • Examine the use and monitoring of water used to grow, spray (pesticides, fungicides), move, rinse or wax crops to identify and minimize risks from potential hazards.
    • Adopt tools and practices needed to enhance traceability. Papayas are a perishable commodity, and traceability information should facilitate the rapid tracking of involved product to expedite its removal from commerce, prevent additional consumer exposures, and properly focus any recall actions.
    • Fund and actively engage in food safety research to identify the potential sources and routes of microbial pathogens and develop data-driven and risk-based preventive controls.
  • FDA noted that the pattern of recurrent outbreaks observed since 2011, including the 2019 illnesses, have involved papaya grown in Mexico. As mentioned in both the industry letter and an agency press release, the FDA has increased sampling and screening of papayas at the U.S.-Mexico border, and is actively collaborating with counterparts in the Mexican government to further prevention efforts. Additionally, FDA has issued a warning letter to the papaya importer, Agroson’s LLC, due to significant violations of the Federal Food, drug, and Cosmetic Act found at the facility in conjunction with the latest Salmonella outbreak.
  • With little fanfare, FDA issued a new Import Alert (IA 99-41) to prevent the importation of foods by importers who are not in compliance with the Foreign Supplier Verification Program (FSVP) Regulation.  The FSVP regulations require importers to evaluate and document their suppliers and the steps taken to ensure the safety of food being imported.  Each food item being imported must have its own FSVP review.
  • An Import Alert is guidance within the Food and Drug Administration (FDA) that certain shipments into the United States should be held until the importer proactively demonstrates compliance with the law.  Additionally, Import Alerts generally explain the problem and provide guidance to FDA field staff on how to uniformly describe the problem in paperwork.  The Import Alert will often have a green list (as an exception to a general rule to prevent products from coming in), a yellow list (to identify entities that are known to be working towards compliance but whose products are still to be detained), or a red list (the specific entities whose products will be detained) of entities.  For example, IA 45-02, for detention of foods containing illegal and undeclared colors has both a green and red list and IA 22-01 for detention of cantaloupes from Mexico has both a green and yellow list.
    • The import alert for FSVP violations directs field staff to consult the red list but, thus far, the red list is empty.  This implies that FDA expects to use the import alert process as a means of targeting importers who do not comply with their regulatory obligations for FSVP.
  • Of interest, the beginning of produce safety inspections, addressed in yesterday’s Daily Intake Blog post, is important not just for produce operations – FDA has previously indicated that it will begin FSVP inspections of importers of produce from large farms “in Fall 2019” which would allow for these inspections to begin “approximately six months after FDA begins routine inspections of those large farms under the Produce Safety rule.”  It may be that the FSVP inspections of imports of produce from large farms will result in the first additions to the red list for IA 99-41.  Given FDA’s policy of using initial FSVP inspections to educate, we might expect the first entrants on the red list to be importers who have already undergone FSVP inspections.

Please feel free to contact Keller and Heckman at fooddrug@khlaw.com with any questions about compliance with FSVP, responding to FDA correspondence regarding an FSVP inspection, or about clearing products listed on an import alert so as to allow imports into the country to proceed.

  • The U.S filed five separate trade cases at the World Trade Organization (WTO) challenging tariffs, many on agriculture products, imposed in response to tariffs announced by President Trump on aluminum and steel. The five countries are China, the European Union, Canada, Mexico, and Turkey. With respect to tariff imposed by China, we previously reported on this blog that the U.S agricultural industry is concerned about potential financial losses due to these tariffs.
  • U.S. Trade Representative Robert Lighthizer said in a press release that the U.S. imposed tariffs were legitimate and justified but that our trading partners responded with retaliatory tariffs rather than working with us to address a common problem. He added, “These tariffs appear to breach each WTO Member’s commitments under the WTO Agreement.  The United States will take all necessary actions to protect our interests, and we urge our trading partners to work constructively with us on the problems created by massive and persistent excess capacity in the steel and aluminum sectors.”