Dear CSCA Members,
Please see the attached email from the Government of Canada’s Market Access Secretariat (MAS) regarding the United States Food and Drug Administration (FDA) Produce Safety Rule enforcement discretion for certain commodities, including pulses.
Pulse Canada is working with MAS to identify the effects, if any, that the FDA’s Product Safety Rule will have on the business of CSCA Members. Updates will be provided to CSCA when received.
Dear industry stakeholders,
In the last few weeks the U.S. Food and Drug Administration (FDA) released guidance and documents that may be of interest to Canadian stakeholders.
Produce Safety Rule Enforcement Discretion for Certain Commodities
On March 28, 2019, the FDA announced that it intends to exercise enforcement discretion for the requirements of the Produce Safety Rule as they apply to entities growing, harvesting, packing, and holding wine grapes, hops, pulse crops, and almonds.
The Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables for human consumption. The rule does not apply to produce that is considered to be rarely consumed raw (RCR) as determined by the FDA, grown for personal or on-farm consumption, some produce undergoing commercial processing, or not a raw agricultural commodity.
After the Produce Safety Rule was finalized, FDA received feedback from stakeholders that wine grapes, hops, pulses, and almonds should be exempt. After conducting an initial review of the production and use of these commodities, FDA has decided to exercise enforcement discretion with respect to the Produce Safety Rule for entities growing, harvesting, packing, or holding these commodities, while they consider pursuing rulemaking to address the unique circumstances they each present.
FDA will continue to enforce the statutory prohibition against introduction or delivery for introduction of adulterated food into interstate commerce.
The guidance document for industry on the enforcement policy for these produce is available here.
On March 27, 2019, the FDA announced that it intends to propose that “cross-linked phosphorylated RS4” , regardless of sources, be added to the definition of dietary fibre. The FDA established a definition for dietary fibre in its Nutrition Facts label final rule, which was published in the Federal Register on May 27, 2016. Based on available evidence, FDA has determined that the scientific evidence suggests that cross-linked phosphorylated RS4 can help reduce insulin levels following a meal containing a carbohydrate that raises blood glucose levels.
16 categories of non-digestible carbohydrates (e.g. mixed plant cell wall fibres, a broad category) are either included in the definition of dietary fibre or are non-digestible carbohydrates that FDA intends to propose to be added to the definition of dietary fibre. Seven of these fibres were identified in the Nutrition Facts label final rule as meeting the dietary fibre definition. Until FDA completes rulemaking regarding adding additional fibres to the regulatory definition of dietary fibre, the agency intends to exercise enforcement discretion to allow manufacturers to include the amount of these additional fibres in the dietary fibre declaration on the Nutrition and Supplement Facts labels.
Certification Bodies Under the FDA’s Third-Party Certification Program
On March 20, 2019, the FDA announced that SGS North America Inc. of Rutherford, NJ, and NSF Certification LCC of Ann Arbor, MI, have become certification bodies (CB) accredited under FDA’s Accredited Third-party Certification Program. SGS has been accredited for the following program scopes (Preventive Controls for Human Food; Juice HACCP, and Seafood HACCP) while NSF has been accredited for (Preventive Controls for Human Food; Juice HACCP, Seafood HACCP, and Produce Safety).
This accreditation means that SGS North America Inc. and NSF Certification LLC have been given the authority to conduct food safety audits and issue food and facility certifications for their relevant program scopes.
Extending Compliance Dates for Agricultural Water Provisions
On March 15, 2019, the FDA issued a rule to finalize the new compliance dates for the agricultural water requirements in the Food Safety Modernization Act (FSMA) Produce Safety Rule
Larger farms are now required to comply with the agricultural water requirements by January 26, 2022, while small farms have until January 26, 2023, and very small farms until January 26, 2024. This rule does not change the compliance dates for sprout operations.
While this rule extends the compliance dates for the agricultural water provisions, produce remains subject to the other provisions of the Produce Safety Rule and the adulteration provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act).
Please let us know if you have any questions,
Market Access Secretariat