Food Product Recalls in Japan: Legal Grounds and Procedural Requirements for Recall Orders

Japan maintains a stringent regulatory framework for food safety, reflecting a high degree of public concern for health and well-being. A key enforcement tool within this framework is the administrative recall order, compelling businesses to remove products from the market deemed to be in violation of the Food Sanitation Act (食品衛生法 – Shokuhin Eisei Hō). While essential for public protection, such orders can have severe financial and reputational consequences for businesses. Understanding the legal grounds for these orders, the procedural requirements an agency must follow, and the avenues for challenging them is crucial for any entity involved in the food industry in Japan.

This article explores these aspects, particularly focusing on disputes that can arise when a recall order is issued, using a common scenario involving the use of "substandard" raw materials in food production.

The Trigger for a Recall: Understanding Article 6 of the Food Sanitation Act

The primary legal basis for prohibiting the sale or use of certain foods, and thus for issuing recall orders, is Article 6 of the Food Sanitation Act. This article broadly prohibits the sale, manufacture, import, processing, use, cooking, storage, or display for sale of foods or additives that "may harm human health" (hito no kenkō o sokonau osore no aru mono).

Article 6 then enumerates specific categories of such prohibited items:

1. Food that is decomposed, deteriorated, or immature (with an exception for items generally recognized as safe and fit for consumption).
2. Food containing or contaminated with toxic or harmful substances, or suspected of such (with exceptions determined by the Minister of Health, Labour and Welfare if no health risk exists).
3. Food contaminated by pathogenic microorganisms, or suspected of such, and which may harm human health.
4. Food that may harm human health due to being unclean, containing foreign matter, or for other reasons.

A critical interpretive point within Article 6 is its dual structure:

• The first part (前段 – zendan) prohibits the sale of food or additives that fall into the categories listed in items 1-4. This targets the final product being offered to consumers.
• The latter part (後段 – kōdan) prohibits, for the purpose of sale, the collection, manufacture, import, processing, use, cooking, storage, or display of food or additives listed in items 1-4. This targets actions taken with or upon such unsafe items, even if the final product intended for sale is argued to be safe.

Disputes often arise over whether a particular raw material or final product indeed "may harm human health" and falls under one of these categories.

The Recall Order Itself: Article 54 of the Food Sanitation Act

When a business is found to have violated Article 6 (among other provisions), Article 54, Paragraph 1 of the Food Sanitation Act empowers the Minister of Health, Labour and Welfare or the relevant prefectural governor (or mayor of a designated city with a public health center) to order the business operator or its employees to dispose of the offending food, additives, apparatus, or containers/packaging, or to "take other necessary measures to eliminate food sanitation hazards." A product recall is a primary example of such "other necessary measures." Article 55 also allows for more severe sanctions like permit revocation or business suspension.

A Case Study: The "Accident-Reported Rice" (事故米穀) Controversy

Consider a hypothetical company that manufactures and sells rice starch. It purchases "accident-reported rice" (jiko beikoku – 事故米穀) from an agricultural agency. This specific batch of rice is deemed "non-edible for human consumption" not due to contamination with specific regulated pesticides (like methamidophos) or potent mycotoxins (like aflatoxin), but due to "general mold, bag tears, etc." The company uses this accident-reported rice as a raw material to produce rice starch. The company argues that its extensive multi-stage manufacturing process—involving milling, washing, sodium hydroxide solution immersion, grinding, sieving, multiple water rinses with centrifugal separation, and heat drying—removes any initial contamination and ensures the final rice starch product is safe for human consumption, meeting all food safety standards. Indeed, no health complaints related to the final product have been received.

However, a public health center, upon discovering the use of this "non-edible accident-reported rice" as a raw material for starch sold without distinction between edible and non-edible applications, issues a recall order for the rice starch under Article 54, citing a violation of Article 6 of the Food Sanitation Act. The company, believing its final product is safe and that the recall order is an overreach, decides to challenge it.

This scenario mirrors real-life controversies in Japan where the use of rice designated for non-food purposes (due to minor mold or damage not necessarily posing direct health risks after processing) in food products became a significant social and legal issue, prompting widespread inspections and regulatory actions.

Challenging a Recall Order: Procedural Grounds

A recall order is an "adverse disposition" (furieki shobun – 不利益処分) under the Administrative Procedure Act (APA) (行政手続法 – Gyōsei Tetsuzuki Hō). As such, the issuing administrative agency must adhere to certain procedural requirements. Failure to do so can render the order illegal.

1. Right to a Hearing or Opportunity for Explanation (APA Article 13)

For significant adverse dispositions like revoking a license, the APA generally requires a formal "hearing" (chōmon – 聴聞) (Article 13, Paragraph 1, Item 1). For less severe adverse dispositions, an "opportunity for explanation" (benmei no kikai no fuyo – 弁明の機会の付与) is required (Article 13, Paragraph 1, Item 2). A recall order, while impactful, typically falls under the category requiring an opportunity for explanation.

In our hypothetical case, if the public health center director issued the recall order without providing any prior opportunity for the company to formally present its case or explanations, this could be a significant procedural flaw. The APA does allow for these procedures to be omitted in cases of "urgent necessity for the public interest" (Article 13, Paragraph 2, Item 1). However, the agency would need to robustly justify such urgency.

A common counter-argument from agencies, as suggested in the background materials for the PDF's "Problem 6," is that if the business has already admitted the factual basis of the violation (e.g., confirmed the use of accident-reported rice), a further formal opportunity for explanation is unnecessary. However, this view is contestable. Even if certain facts are admitted, their legal interpretation (e.g., whether those facts constitute a violation of Article 6) and the appropriateness of the chosen sanction (a recall order) remain crucial points on which the business should have a right to be heard. The procedural right is not merely about contesting facts but also about arguing the law and the proportionality of the impending action.

2. Adequacy of Reasons (APA Article 14)

Article 14, Paragraph 1 of the APA requires that when an agency issues an adverse disposition, it must concurrently show the recipient the reasons for it. The purpose of this requirement is twofold:

• To ensure careful and rational decision-making by the agency and to curb arbitrariness.
• To inform the recipient of the grounds for the disposition, enabling them to decide whether to seek review and how to prepare their case.

The Supreme Court of Japan has held that the reasons provided must be sufficient to allow the recipient to understand the factual basis and the application of law that led to the disposition from the content of the notice itself (e.g., Supreme Court, Third Petty Bench, Judgment of January 22, 1985, Minshu Vol. 39, No. 1, p. 1; Supreme Court, Third Petty Bench, Judgment of June 7, 2011, Minshu Vol. 65, No. 4, p. 2081).

In our case, if the recall order merely stated "Violation of Food Sanitation Act Article 6" and described the conduct as "manufacturing rice starch from non-edible accident-reported rice due to mold, etc., and selling it without distinction," this might be deemed insufficient. The company could argue that it's unclear:

• Which specific item of Article 6 (1 through 4) was violated.
• Whether the violation pertains to the raw material (the accident-reported rice) or the final product (the rice starch).
• How the "general mold, bag tears, etc." on the raw rice translates to a food that "may harm human health," especially if the final product is demonstrably safe.

If the reasoning is too vague to allow the company to understand the precise legal and factual basis for the recall, it can be challenged as a violation of APA Article 14. Such a procedural defect is generally considered grounds for revoking the disposition. The Niigata District Court, in a case similar to our hypothetical (Judgment of November 17, 2011, Hanrei Times No. 1382, p. 90), found a recall order illegal due to inadequate reasons, although this was overturned on appeal by the Tokyo High Court (Judgment of June 20, 2012, LEX/DB 25482659), which found the reasons sufficient in that specific instance, highlighting the nuanced judicial assessment involved.

Challenging a Recall Order: Substantive Grounds

Beyond procedural flaws, a company can challenge the substantive legality of the recall order.

1. Misinterpretation of Food Sanitation Act Article 6

This is often the core of the dispute. The company might argue:

• The final product is safe (challenging a violation of the first part of Article 6): If the company can scientifically prove that its manufacturing process eliminates any potential hazards from the raw materials and that the final rice starch is safe and compliant with all standards, it can argue that selling this final product does not violate Article 6. The fact that no health issues have been reported from the final product would support this.
• The raw material itself did not "may harm human health" under Article 6 (challenging a violation of the latter part of Article 6): This is a more challenging argument if the raw material was officially designated "non-edible." However, the company could argue that "non-edible due to general mold, bag tears, etc." does not automatically equate to the specific dangers listed in Article 6, Items 1-4 (e.g., "decomposed," "containing toxic substances," "contaminated by pathogenic microorganisms," "unclean to the extent of potentially harming health"). If the "accident-reported rice" in question was not, for example, contaminated with regulated levels of mycotoxins or pesticides, but was downgraded for aesthetic or minor quality reasons that processing could rectify, the company might argue that its use as a raw material for a purified food product did not fall foul of the latter part of Article 6.
  The authorities, in contrast, often take a stricter view, especially following social controversies like the widespread misuse of accident-reported rice. They might argue that any rice officially designated "non-edible" inherently falls under Article 6 (e.g., as "unclean" or "deteriorated" in a way that "may harm human health" if not properly segregated and controlled), and its use in food production is a per se violation of the latter part of Article 6, regardless of the final product's claimed safety. The legislative intent behind the latter part of Article 6, as sometimes interpreted, is to strongly protect public health by prohibiting the very introduction of such questionable materials into the food production chain at an earlier stage.

2. Principle of Proportionality (Hirei Gensoku – 比例原則)

Even if a technical violation of Article 6 is found (e.g., the use of "non-edible" raw material was improper), the company can argue that a full recall order for a demonstrably safe final product is a disproportionate measure.

• The principle of proportionality requires that administrative measures be (1) suitable to achieve the legitimate regulatory purpose, (2) necessary, in that no less intrusive means are available, and (3) proportionate in the narrow sense, meaning the burden imposed on the individual is not excessive in relation to the public interest being served.
• If the final rice starch is safe, a full recall might be deemed unnecessary to protect public health. Less intrusive measures, such as requiring clearer labeling about raw material sourcing (if that were the concern), stricter future controls on raw material use, or targeted testing, might be sufficient. A recall imposes significant financial costs, damages reputation, and leads to food waste, all of which should be weighed against the actual risk posed by the final product.

3. The Precautionary Principle (Yobō Gensoku – 予防原則) vs. Proportionality

Administrative agencies, particularly in food safety, often operate on a precautionary basis. They might argue that even if the final product's harm isn't definitively proven, the use of substandard raw materials creates an unacceptable risk, and a recall is justified to prevent potential harm and maintain public confidence. The Food Sanitation Act's emphasis on "may harm human health" (osore ga aru) incorporates this precautionary approach.

However, the company would argue that the precautionary principle should not be applied so broadly as to ignore scientific evidence of the final product's safety or to impose disproportionate burdens. While precaution is valid, it must be balanced with principles of rational decision-making and proportionality. The debate then centers on the level of risk that justifies a recall and whether the agency's assessment of that risk, and the chosen remedy, were reasonable. The latter part of Article 6, prohibiting the use of problematic raw materials, can be seen as a legislative embodiment of the precautionary principle for the food manufacturing process itself.

Practical Implications for Food Businesses in Japan

The complexities surrounding food recall orders underscore several critical points for businesses in the Japanese food sector:

• Scrutiny of Raw Materials: Japanese authorities maintain a strict stance on the sourcing and use of raw materials. Any ambiguity regarding the suitability of an ingredient for human consumption, even if processing is believed to render it safe, can lead to regulatory action.
• Due Diligence and Supply Chain Integrity: Robust due diligence on suppliers and transparent supply chains are essential.
• Process Validation and Final Product Testing: While critical, demonstrating final product safety alone might not be sufficient if raw material regulations are breached. However, strong data on process efficacy and final product safety is vital for any legal defense or negotiation with authorities.
• Understanding Procedural Rights: If faced with an investigation or a potential adverse disposition like a recall, businesses must be aware of their procedural rights under the APA, including the right to be heard and the right to receive clear and adequate reasons for any action taken.
• Proactive Engagement with Authorities: Open communication with public health authorities and a cooperative stance during investigations can sometimes lead to more measured responses, although this is not guaranteed.

Conclusion

Food product recall orders in Japan are a powerful regulatory tool aimed at safeguarding public health. However, their issuance can involve complex legal and factual determinations, particularly concerning the interpretation of the Food Sanitation Act and the application of administrative procedures. Businesses must navigate a landscape where the safety of both raw materials and final products is scrutinized, and where procedural fairness and the proportionality of administrative actions are key considerations. While the primary goal is consumer protection, ensuring that regulatory actions are legally sound, procedurally correct, and proportionate is vital for maintaining a fair and predictable business environment.