As the regulations on food safety in the US become stricter, an increasing number of Chinese food producers that sell products to the US are facing regulation and onsite inspections by the US Food and Drug Administration (FDA). However, unfamiliarity with relevant FDA regulations, cultural differences and numerous other factors regularly place Chinese facilities at a disadvantage when responding to FDA inspections, even leaving them sometimes at risk of being penalized. Therefore, the authors would like to share some key compliance points in the response by food product enterprises to routine inspections conducted by the FDA.

FDA registration and recordal with the domestic inspection and quarantine authorities. The FDA Food Safety Modernization Act (FSMA) revises section 415 of the Federal Food, Drug and Cosmetic Act (FDCA), requiring facilities that manufacture, process, pack or hold foods for consumption in the US to: (1) register with the FDA and update such registration once every two years; and (2) submit additional registration information to the FDA, including warrantying that they will permit the FDA to inspect their facilities at the times, and in the manner, permitted by the FDCA. These registration requirements apply to Chinese food production, processing and packing facilities (export facilities) that sell products to the US.

The FDCA requires export facilities to register with the FDA. However, in practice, as many export facilities have adopted the distribution model to sell their products – i.e., they sell their products to distributors, which then sell the relevant products abroad – numerous FDA registrations are actually carried out by the distributors on the behalf of the export facilities, a fact of which the export facilities are not necessarily aware, or to which they give tacit consent, and their registered contact information may be inconsistent with the actual particulars of the export facility. Accordingly, most export facilities, when they receive an FDA inspection notice, are not aware that they have been registered with the FDA. In an onsite inspection, the FDA officials will inquire about the export facility’s registered particulars, and the facility can admit the above situation truthfully.

Furthermore, it needs to be stated that the main authority in China with which the FDA interacts is the State Administration of Quality Supervision, Inspection and Quarantine (SAQSIQ). At the beginning of the year, the FDA will usually send a list of the entities it proposes to inspect to the SAQSIQ, which then notifies the relevant export facilities.

Pursuant to the Administrative Provisions for the Recordal of Export Food Producers, an export food producer is required to apply for recordal with the local inspection and quarantine authority, and where such producer fails to carry out its statutory obligation of carrying out recordal or is found after a recordal review not to satisfy the requirements, it may not export its products.

However, because certain export facilities have not carried out recordal with the inspection and quarantine authority, the inspection and quarantine authority does not have their information and is unable to notify them. Accordingly, such an export facility often will learn that FDA officials are coming to conduct an inspection only one week or so before they arrive, making it impossible to take reasonable measures to respond to such inspection, or its normal operations may be interrupted, or other such adverse impact may occur as the result of the FDA onsite inspection.

Production processes and procedures. An FDA onsite inspection usually lasts two to three days. During such an inspection, the FDA officials usually request that they be allowed to see the export facility’s production lines, inspect the sanitization of the production lines, familiarize themselves with the production processes and procedures and familiarize themselves with the substances that come into direct contact with the food products, including the raw materials, production water, steam, oil, additives, etc.

The FDA officials will also inquire about and inspect whether the export facility has a food quality monitoring system, whether the quality control personnel have the appropriate training or qualifications, and whether the facility has a quality testing laboratory, so as to get a general picture of the circumstances of the export facility and its products for export. For details, reference may be made to the Foreign Food Facility Inspection Programme questions and answers posted on the FDA’s website.

Food safety plan. Section 418 of the FDCA requires the owner, operator or agent in charge of a facility to analyze the hazards that could affect the food manufactured, processed, packed or held by such facility, identify and take preventive control measures to significantly minimize or prevent the occurrence of such hazards, and ensure that such food is not adulterated or misbranded under the act. The above-mentioned analysis and preventive control measures are specifically reflected in whether the export facility complies with the food safety plan specified by the FDA, and whether its implementation complies with FDCA requirements.

In the course of an onsite inspection, the FDA officials will draft a food safety plan based on what they learn during the onsite inspection and compare it with the food safety plan provided by the export facility to determine whether the export facility has identified relevant hazards and taken preventive control measures that comply with FDCA’s requirements.

Given that the relevant standards applicable to food safety management systems in China include GB/T22000-2006, ISO22000 (including hazard analysis and critical control point, or HACCP), FSSC22000, etc., the FDA officials will inquire as to whether the export facility has a HACCP plan, pest control plan, recall plan, employee training plan, etc., and about the implementation of the above-mentioned plans. However, it should be noted that the documents submitted to the China Quality Certification Centre when applying for food safety system certification may be different from the ones required by the FDA for a HACCP plan. The specific risks need to be assessed based on the actual circumstances.

Other key points. Pursuant to the FSMA, within one year from the enactment of the FSMA (September 2015), the FDA is required to inspect not less than 600 foreign enterprises. After that initial one-year period, every five years the FDA is required to inspect not less than twice the number of foreign enterprises that it inspected in the first year. Accordingly, FDA onsite inspections of export facilities (particularly Chinese facilities that sell a large quantity of products to the US) will become a regular occurrence. Export facilities need to actively respond to FDA onsite inspections and refine their food safety management systems.

Amy Ye is a senior partner and Dora Feng is an associate at AllBright Law Offices. Huang Xuan, a partner at AllBright, also contributed to this article