Released U.S. FDA documents and information

The following notice is from Agriculture and Agri-Food Canada

In the last month, the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA) released guidance and documents that may be of interest to Canadian stakeholders.

Importation of Hemp Seeds

On April 18, 2019, the USDA released information regarding the imports requirements for hemp seeds. The passing of the Agriculture Improvement Act of 2018 (2018 Farm Bill, Section 10113) removed hemp and hemp seeds containing THC levels not greater than 0.3 percent from the Drug Enforcement Administration's (DEA) Schedule of Controlled Substances. As a result, the DEA no longer has to issue import permits before hemp seeds can be imported.

In lieu of the DEA permit, hemp seed can now be imported into the U.S. from Canada if accompanied by either: 1) a phytosanitary certification from the Canadian Food Inspection Agency verifying the origin of the seed and confirming that no plant pests are detected; or 2) a Federal Seed Analysis Certificate (SAC, PP0 Form 025) for hemp seed grown in Canada.

More information is available here.

FDA Intentional Adulteration Inspections to begin March 2020

During a public meeting on April 17, 2019, the FDA indicated that routine inspections to verify compliance with the International Adulteration (IA) Rule will begin in March 2020. The IA Rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health. Unlike other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

Food facilities covered by the rule will be required to develop and implement a food defence plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. The first compliance date for the FSMA IA Rule is July 26, 2019, for companies other than small businesses, very small businesses or businesses qualifying for exemptions. Draft guidance on the rule is available here.

Voluntary recall guidance

On April 24, 2019, the FDA released draft guidance aimed at helping companies better handle voluntary recalls of food and other products. In the case of a recall, Canadian companies should closely work with their U.S. importers and the firms selling their products in the U.S. to ensure that they meet U.S. requirements

Comment on the draft guidance can be submitted on or before June 24, 2019.

Rescission of Dual Labelling Requirements for Certain Packages of Meat and Poultry

On April 17, 2019, the USDA released a proposed rule that would amend its labelling regulations to remove provisions that require packages of meat or poultry products that contain at least one pound or one pint, but less than four pounds or one gallon, to express the net weight or net content in two different units of measurement on the product label.

Comments on the proposed rule can be sent on or before June 17, 2019, at the following address:

https://www.regulations.gov/document?D=FSIS-2018-0012-0001

Publication method for lists of foreign countries eligible to Export Meat, Poultry, or Egg Products to the United States

On April 12, 2019, the USDA released a proposed rule that would remove lists of foreign countries eligible to export meat, poultry, and egg products to the United States from its regulation and, instead, ulitize lists posted on the Food Safety and Inspection Service (FSIS) website. A reference to the web address would be included in FSIS' regulations. The criteria FSIS uses to evaluate whether a foreign country is eligible to export meat, poultry, or egg products would remain in the regulation and would not change.

Comments on the proposed rule can be sent on or before June 11, 2019, at the following address:

https://www.regulations.gov/document?D=FSIS_FRDOC_0001-0606

Fluoride in bottled water

On April 4, 2019, the FDA released a proposed rule to revise the quality standard for bottled water to specify that bottled water to which fluoride is added by the manufacturer may not contain fluoride that exceeds 0.7 milligrams per litre (mg/L). If finalized, the proposed rule would amend the allowable levels of fluoride in domestically packaged and imported bottled water to which fluoride is added.

Comments on the proposed rule can be sent on or before June 3, 2019, at the following address:

https://www.regulations.gov/docket?D=FDA-2018-N-1815

Declaration of Allulose on the Nutrition Facts Label

On April 17, 2019, the FDA issued a draft guidance to provide its current view on the declaration of carbohydrates, total sugars and added sugars for products that contain allulose, a sweetener, on the Nutrition Facts label. The draft guidance also provides FDA's current view on calculating the caloric value of allulose. The guidance is designed to assist manufacturers in complying with the Nutrition Facts Label requirements.

Comments on the draft guidance can be submitted on or before June 17, 2019, at the following address:

https://www.regulations.gov/document?D=FDA-2019-D-0725-0001

Questions can be directed to:
Market Access Secretariat
Agriculture and Agri-Food Canada
Email