December 11, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update: Hogan Lovells Memoranda - FSMA Final Rules (FDA Implements JPA Recommendation); Hogan Lovells Memorandum - FDA's Genetically Engineered Food Labeling Initiatives; Hogan Lovells Memorandum - Federal Regulatory Agendas Published; Hogan Lovells Memorandum - WTO Decision on Country of Origin Labeling - Possible Impact to Juice Industry; Warning Letter - Juice HACCP Violations; EPA Proposal To Revoke Chlorpyrifos Tolerances; IFU News December 2015 (JPA Research Highlighted); FDA Publishes Proposed Rule on “Gluten-Free” Labeling of Fermented or Hydrolyzed Foods; Representative Pingree Introduces Legislation to Reduce Food Waste
Hogan Lovells Memoranda - FSMA Final Rules (FDA Implements JPA Recommendation)
On November 13, 2015, JPA staff notified members that the Food and Drug Administration (FDA) had released three final rules to implement the FDA Food Safety Modernization Act (FSMA). The prepublication versions of the FSMA final rules and associated Fact Sheets were earlier shared with members. The FDA has published the formal version of the final rules in the Federal Register, which are available via the links below.
Produce Safety (80 FR 74354)
Foreign Supplier Verification Program (80 FR 74226)
Accreditation of Third-Party Auditors/Certification Bodies (80 FR 74570)
JPA's legal counsel, Hogan Lovells, has published memoranda highlighting the key provisions of the final rules, which can be accessed via the following links: Foreign Supplier Verification Program, Produce Safety, and Accreditation of Third-Party Auditors/Certification Bodies.
Juice Exempt from the Foreign Supplier Verification Program (FSVP) Requirements
The final rule exempts importers of juice from foreign suppliers that are in compliance with the juice HACCP regulation from the FSVP requirements.
Of particular note, in comments JPA submitted to the FDA related to the FSVP proposed rule, JPA urged the Agency to expand the exemption for juice to also include all ingredients/raw materials used in a facility that is in compliance with the juice HACCP regulation provided those ingredients would be used in the manufacture of juice HACCP regulated products. On page 74249 of the final rule, the Agency agrees with JPA's recommendation. The FDA notes the final rule states the FSVP regulation does not apply with respect to raw materials or other ingredients an importer uses in manufacturing or processing juice subject to juice HACCP provided the importer complies with the relevant regulation when manufacturing or processing the juice.
Processed Fruit Exempt from Produce Safety Rule
The final rule exempts produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance. Juices that comply with the juice HACCP regulation would be exempt from the requirements of this rule. In comments JPA submitted to the FDA, it was requested that the Agency maintain cranberries on the list of produce types that are rarely consumed raw and therefore exempt from the produce rule. Cranberries are exempt from the final rule requirements.
In the proposed rule, the Agency proposed that covered produce would not be permitted to be used if it drops to the ground before harvest. In comments submitted to the FDA, JPA requested that citrus fruits be exempt from the restriction on the use of dropped fruit due to the fruit's outer skin. The FDA did not exempt citrus fruits from the requirement.
A webinar regarding the FSMA final rules and facilitated by Hogan Lovells is being planned for January 2016. Details regarding the webinar will be distributed in the near future.
Hogan Lovells Memorandum - FDA's Genetically Engineered Food Labeling Initiatives
JPA members were previously notified that the Food and Drug Administration (FDA) had issued the final guidance, “Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants” related, in part, to labeling claims for foods that do not contain genetically engineered (GE) ingredients and claims for those foods that do contain GE ingredients.
Members were also recently advised that the FDA had denied a petition submitted by the Center for Food Safety (CFS) requesting that the Agency require the labeling of GE foods. In addition, JPA staff reported that the FDA had approved a GE salmon (AquAdvantage Salmon) and released a draft guidance regarding the labeling foods derived from Atlantic salmon.
Hogan Lovells has published a memorandum, available here, providing details regarding the FDA's efforts highlighted above.
JPA will continue to monitor federal and state initiatives regarding the labeling of GE foods and provide updates, as information becomes available.
Hogan Lovells Memorandum - Federal Regulatory Agendas Published
The White House has published the “Current Regulatory Plan and the Unified Agenda of Regulatory and Deregulatory Actions” for fall 2015. It details the regulatory agendas from Federal agencies, including the Department of Health and Human Services (HHS), United States Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). The proposed HHS and FDA rulemaking activities are available here and the USDA regulatory activities are available here.
Hogan Lovells has published a memorandum highlighting key FDA and USDA rulemaking efforts. The memorandum can be accessed here.
Of particular note, the FDA expects to publish a final rule regarding the Agency’s food labeling modernization effort in March 2016.
Hogan Lovells Memorandum - WTO Decision on Country of Origin Labeling - Possible Impact to Juice Industry
JPA has previously notified members that Canada and Mexico are considering imposing retaliatory trade sanctions on certain U.S. products due to a dispute over the U.S. country of origin labeling (COOL) requirements for beef and pork products. The COOL regulations provided that U.S. origin labeling would be permitted only on meat obtained from animals born, raised, and slaughtered in the U.S. Canada and Mexico challenged the regulation and ultimately, the World Trade Organization (WTO) ruled against the U.S.
Hogan Lovells has published a memorandum, available here, providing an update on the COOL issue. According to legal counsel, a WTO Arbitrator recently found that Canada and Mexico incurred annual trade damage of $1.017 billion. Canada and Mexico have requested a meeting of the WTO's Dispute Settlement Body on December 18 to obtain authorization to impose retaliatory duties on an equivalent amount of U.S. products.
Frozen orange juice, apples and cherries are on Canada's 2013 preliminary retaliation list of targeted products. Hogan Lovells recommends, "Any company exporting products to Canada, which are on Canada's 2013 preliminary list, should try to get them cleared through Canadian customs before December 18. These companies should also be prepared to pay the punitive duties, or have precautionary arrangements in place in case their goods are subject to prohibitive duties and need to be shipped back to the U.S." Hogan Lovells also notes, "Any company which is shipping goods to Mexico - including apples, dairy, alcoholic beverages, and personal hygiene products - should be prepared to make similar arrangements."
Review the Hogan Lovells memorandum for complete details, which includes Canada's 2013 preliminary retaliation list of products.
JPA will continue to monitor and provide updates, as information becomes available.
Warning Letter - Juice HACCP Violations
The FDA recently published a Warning Letter, available here, to Lehman Family Farms/Home Grown Cellars citing "serious" violations of the Juice Hazard Analysis and Critical Control Point (HACCP) regulation codified in 21 Code of Federal Regulations Part 120.
EPA Proposal To Revoke Chlorpyrifos Tolerances
JPA members were earlier notified that the Environmental Protection Agency (EPA) had published a proposed rule in the Federal Register (80 FR 69080; November 6, 2015) to revoke all tolerances for the insecticide chlorpyrifos. It was noted that the EPA had been ordered by a court to respond by October 31, 2015 to a petition filed by the National Resources Defense Council (NRDC) and the Pesticide Action Network North America (PANNA). The petition requested that the Agency revoke all chlorpyrifos tolerances and cancel all registrations of products containing the insecticide due to possible risk to human health.
Chlorpyrifos tolerances are codified in 40 Code of Federal Regulations (CFR) Part 180.342. Tolerances have been established for residues on a number of fruits including apple, citrus, banana, cranberry, cherry, pear, peach and strawberry.
According to the December 10, 2015 issue of POLITICO Pro Agriculture, the 9th Circuit Court of Appeals ordered the EPA to take final action on the proposal to revoke the tolerances by December 30, 2016. The EPA is also required to provide an update on the status of the proposed revocations by June 30.
IFU News December 2015 (JPA Research Highlighted)
The International Federation of Fruit Juice Producers, now known as the International Fruit and Vegetable Juice Association (IFU), recently published the December 2015 newsletter, available here. Of particular note, the newsletter highlights JPA's six research studies published this year demonstrating the health benefits of consuming 100% juice. Review the newsletter for complete details on IFU activities.
FDA Publishes Proposed Rule on “Gluten-Free” Labeling of Fermented or Hydrolyzed Foods
On November 18, 2015, JPA notified members that the Food and Drug Administration (FDA) had released a proposed rule “to establish requirements concerning “gluten-free” labeling for foods that are fermented or hydrolyzed or that contain fermented or hydrolyzed ingredients." A copy of the proposed rule published in the Federal Register is available here. JPA staff developed a document, available here, highlighting the areas in which the FDA is seeking input; however, comments may be submitted on any aspect of the proposed rule. While beverages typically do not contain gluten, this information is provided in case the proposed rule is applicable to other foods produced by your firm.
The FDA is also requesting comments on the Preliminary Regulatory Impact Analysis (PRIA), which examines the benefits and costs of the proposed rule. The PRIA is available here.
The deadline to submit comments to the FDA is February 16, 2016. If you believe JPA should submit comments on the proposed rule, please provide your detailed input to Headquarters by the close of business January 8, 2016.
Representative Pingree Introduces Legislation to Reduce Food Waste
JPA earlier notified members that the United States Department of Agriculture (USDA) had published a press release announcing the Agency is partnering with the Environmental Protection Agency (EPA), charitable organizations, faith-based organizations, the private sector and local, state and tribal governments to reduce food loss and waste.
It was also earlier reported that Representative Chellie Pingree (D-ME) had announced that she is drafting legislation to reduce food waste by changing, in part, the way "sell by" or "best by" dates are used on food products. Representative Pingree noted consumers mistakenly think there is a standard for “best by” dates mandated by the government and believe foods should be discarded when the date has passed; however, manufacturers determine those dates and much of the food is safe to consume after the date.
According to press releases posted on Representative Pingree's website, available here, the "Food Recovery Act" was introduced in Congress on December 7, 2015. H.R. 4184 is available here. In part, the legislation would reduce food waste at the consumer level, federal level, in schools, on farms, and in grocery stores and restaurants. Some of the key provisions of the legislation are highlighted below.
- "Combat consumer confusion by clarifying that 'sell-by' dates are manufacturers' quality suggestions only, require uniform labeling language.
- Extend and expand tax deductions for farmers, retailers, and restaurants that done high-quality food to organizations serving people who are food insecure.
- Encourage school cafeterias to purchase lower-price 'ugly' fruits and vegetables.
- Require companies that receive food service contracts with the federal government, including Congressional cafeterias, U.S. military bases, and federal prisons, to donate surplus food to organizations like food banks, food pantries, and soup kitchens.
- Direct USDA to develop new technologies to increase shelf life of fresh food.
A summary of the legislation's requirements is available here.
As always, please contact me with questions or comments.
Patricia Faison
(404) 252 - 3663
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