Federal regulations require cider processors to develop a HACCP plan and pasteurize their product if they:
Cider makers are exempt from the federal regulation if they:
Under Pennsylvania food safety regulations, cider makers must obtain food safety training under the Food Employee Certification Act if:
The following sections describe federal and state regulations that are designed to insure the safety of apples and apple products.
a. Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food (21 CFR Part 110)
Apple growers and packers are by legal definition considered to be engaged solely in the harvesting, storage, or distribution of raw agricultural commodities and therefore are not required to follow Good Manufacturing Practices (GMPs). However, peeling, coring, cutting, or extracting juice from apples are considered to be processing operations and are subject to GMPs. Implementation of GMPs in juice or cider facilities is covered under the new HACCP regulation and is described in more detail below.
Growers and packers should be aware that government agencies throughout the world are increasingly recommending that Good Agricultural Practices (GAPs) be followed to prevent food safety hazards from occurring on the farm or orchard and in packing houses. Food safety standards for safe growing and packing of fresh produce include FDA's "Guide to Minimizing Microbial Food Safety Hazards on Fresh Fruits and Vegetables" (FDA, 1998) and the World Health Organization farm-to-fork standards in the "Codex Alimentarius--recommended International Code Of Practice General Principles Of Food Hygiene" (WHO, 1997). Although these documents carry no regulatory authority, they are increasingly being used by buyers of fresh produce as sanitation and food safety standards that must be met as a condition of sale.
b. Food Labeling: Warning and Notice Statement; Labeling of Juice Products (21 CFR Part 101)
In 1998, the Food and Drug Administration (FDA) required that all fresh fruit juices that have not received a pasteurization treatment equivalent to a 5-log (1/100,000) reduction in harmful bacteria have a separate label that warns of the potential for product contamination. Since the ruling took effect in September 1999, all juice and cider processors have had to place the following statement on their product:
WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.
The label must have the word WARNING set in bold capitalized letters and a type size no less than 1/16 inch in height. The warning label must be set off in a ‘hairline' box from the rest of the label information.
If untreated juice products are sold in package form, they are required to bear the warning statement. However, untreated juice products sold in retail establishments (restaurants, delis, some grocery stores, and roadside stands) that are intended for immediate consumption and are not pre-packaged do not require warning statements. Although the FDA's jurisdiction is technically limited to interstate commerce, the regulation is being broadly enforced by local authorities to include intrastate distribution as well.
c. Hazard Analysis and Critical Control Point (HAACP); Procedures for the Safe and Sanitary Processing and Importing of Juice (21 CFR Part 120).
The Ruling
On January 19, 2001, the Food and Drug Administration issued a final ruling that requires juice processors, including some cider makers, to develop and implement a Hazard Analysis and Critical Control Point (HACCP) plan that includes control measures sufficient to achieve a 5-log (99.999 percent) reduction in harmful pathogens. As of January 2004, all processors of fruit or vegetable juices (including apple cider), purees, or their concentrated products must comply, regardless of size. The regulation applies to juice products in both interstate and intrastate commerce.
It is important to understand that persons who produce cider and sell it to individual customers within their own retail operation (e.g., roadside stands or farmers markets) are exempt from the regulation. However, retail operations producing unpasteurized juice or cider must still adhere to Good Manufacturing Practices and bear the warning statement described above that informs at-risk consumers of the hazards associated with untreated juices. Exempt cider makers are also urged to voluntarily apply HACCP principles in their operations, especially when children or the elderly are potential customers.
d. The Pennsylvania Food Employee Certification Act
Pennsylvania law requires one supervisory employee in each cider-making establishment to become certified in food safety and sanitation by July 1, 2004. Certified training programs may be obtained through classroom, computer-based, combination home study/classroom, or home study. For information on available training programs, contact the Pennsylvania Department of Agriculture, or Penn State's Department of Food Science.