FDA to Hold Webinar on Guidance on Hazard Analysis and Risk-Based Preventive Controls

The Food and Drug Administration announced it will hold a webinar on the draft guidance document addressing Subpart C of the Food Safety Modernization Act "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals." The webinar will be held March 6 from 2-3:30 p.m. (EST). Information for joining the webinar is here.

FDA Releases Draft FSMA Guidance Amid Government Shutdown

Prior to the government shutdown, the Food and Drug Administration prepared and released a draft guidance document for hazard analysis and risk based preventive controls. FDA posted the document to the Federal Register for publication tomorrow. Comments will be accepted until July 23.

According to the Center for Veterinary Medicine update, the document covers five chapters:

  • food safety plan requirements;
  • recommendations for conducting a hazard analysis;
  • hazards associated with the manufacturing, processing, packing and holding of animal food;
  • examples of preventive controls that may be used to significantly minimize or prevent animal food hazards; and
  • preventive control management components.

Appendix E lists animal food ingredients with specific references to different hazards. At first glance, this document seems to take the same approach of the human food draft guidance. Future chapters still have not been released for human food.

FDA stated that the guidance is designed to cover the entire spectrum of facilities subject to the animal food preventive controls requirements, and, therefore, not all of its content will be applicable to all facilities. FDA also said it intends to publish additional guidance on the animal food preventive controls provisions and will continue to announce additional guidance as it becomes available. As an example, FDA noted that a future guidance document will provide in-depth guidance on the supply-chain program preventive control.

Compliance Dates

Businesses that are not classified as “small” or “very small” businesses under the rule were required to comply with the animal food preventive control provisions on Sept. 18, 2017. “Small” businesses need to comply by no later than Sept. 17, 2018, and “very small” businesses need to comply with limited provisions by Sept. 17, 2019.

ELD Ag Exemption in Place, but Not for Feed

While December 18, 2017, was the deadline for implementation of the electronic logging device (ELD) final rule for truck drivers and vehicles – after that date all vehicles and drivers previously required to complete paper log books are required to have a grandfathers Automated On-Board Recording Device (AOBRD) or ELD – feed companies do not benefit from a limited exemption, the American Feed Industry Assn. (AFIA) reports.

AFIA told its members there is a 90-day waiver from the ELD requirements for those moving “agricultural commodities,” defined by the Federal Motor Carrier Safety Administration (FMCSA) rules. While the exemption includes “livestock,” livestock feed is not part of the definition. AFIA was told by FMCSA that the key phrase in the formal definition is “non-processed” ag commodities, and the agency considers feed to be processed and to fall under the definition of “farm supplies,” not commodities. 

Said AFIA, however: “To ease the transition to ELDs, FMCSA’s partners at the Commercial Vehicle Safety Alliance have announced a delay in placing non-ELD compliant vehicles out-of-service until April 1, 2018, which will allow more time for carriers and law enforcement to adjust to the new technology. FCMSA also announced that violations cited between now (December 18) and April 1, will not count against a carrier’s Safety Measurement System scores.”

New Soybean Export Procedures from USDA

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) on Dec. 27 issued a public statement and two additional explanatory materials – a fact sheet and a frequently asked questions document – concerning the new procedures it adopted to comply with Chinese phytosanitary import requirements in what it said is an effort to maintain the uninterrupted flow of U.S. soybeans to America’s largest export market.

Effective Jan. 1, an additional declaration must be provided on APHIS issued phytosanitary certificate indicating if a given U.S. soybean export consignment to China exceeds 1 percent foreign material (FM).

Procedural Change

The additional declaration on APHISissued phytosanitary certificates for U.S. soybean consignments exceeding 1 percent FM applies to all U.S. soybean exports to China, including bulk and container shipments. For consignments exceeding 1 percent FM, the additional declaration (AD) reads: “This consignment exceeds 1% foreign material.”

When U.S. shipments exceeding 1 percent foreign material arrive at the destination, APHIS said, China will determine whether to provide additional inspection, cleaning, treatment or other phytosanitary-protective measures to minimize the potential propagation of quarantine weed seeds of concern to China. APHIS said China also may require Chinese importers to manage any phytosanitary risks related to U.S. soybean shipments exceeding 1 percent FM.

Separately, FGIS on Dec. 27 modified its directive (9180.85) regarding the insertion of a statement in the “remarks” section of the FGIS 921-2 (inspection report – insects in grain) for Chinese-bound U.S. soybean export consignments. Initially, FGIS had stated that the following statement – “This consignment exceeds 1% FM” – would be inserted in the remarks section of such shipments that exceeded 1 percent FM, and that no statement would be placed in the remarks section of the FGIS form for shipments that contain 1 percent or less foreign material. However, FGIS under its revised procedure now also is including in the remarks the following statement – “This consignment is less than or equal to 1% FM” – for those shipments that contain 1 percent or lower FM.


The longer-term systems-based approach agreed to by USDA and China will focus on weed seed control across the U.S. grain supply chain, as well as appropriate protective measures that can be implemented at Chinese import destinations. Within the United States, the focus primarily will be on the development of weed seed control best practices at the farm level, including through agronomic, harvesting and other measures.

China buys 36+ million tons of soybeans from the United States. No other country could satisfy that demand. What's worth noting is that China's FM Concern and procedures do not apply to South American origin soybeans.