Recent FDA Juice HACCP Regulations
By Shellee Anderson Series Editor: Catherine “Kitty” Bailey, M.ED.
The Hazard Analysis & Critical Control Points (HACCP) concept is a systematic approach to the identification and assessment of the risk (likelihood of occurrence and severity) of biological, chemical and physical hazards from a particular food production process or practice and the control of those hazards. HACCP is a preventive food safety strategy under which the food producer develops a plan that anticipates and identifies the points in the production process where a failure would likely result in a food hazard being introduced or allowed to persist. These points are referred to as critical control points (CCPs). Under HACCP, identified CCPs are systematically monitored to ensure that critical limits are not exceeded and that records are kept of that monitoring. Corrective actions are taken when control of a CCP is lost, including proper disposition of the food produced during that period, and these actions are documented. The effectiveness of the HACCP plan is also systematically verified by the processor.
History of Government Interest in HACCP
On Aug. 4, 1994, the U.S. Food and Drug Administration (FDA) published an advance notice of proposed rulemaking requesting public comment about whether and how the agency should develop regulations that would establish requirements for a new comprehensive food safety assurance program, based on HACCP, for both domestically produced and imported foods. The agency stated its belief that, if such regulations were issued, they would enhance FDA’s ability to ensure the safety of the U.S. food supply. FDA requested comments on a number of specific issues, as well as on all aspects of such a food safety program.
Since 1994, FDA has conducted a HACCP pilot program with volunteers from the food industry. The pilot program was intended to provide information that FDA could use in deciding whether to propose to adopt regulations and in developing and implementing a regulatory system in which food manufacturers are required to perform the food safety aspects of their operations based on HACCP principles.
FDA finalized on Dec. 18, 1995, a regulation to require seafood processors to develop, implement and document sanitation control procedures and to mandate the application of HACCP principles to the processing of seafood. Similarly, USDA established regulations to require meat and poultry establishments to develop and implement written sanitation standard operating procedures (SSOPs) and a system of HACCP controls designed to improve safety.
Why HACCP for Juice?
In the last decade a significant food safety problem emerged with juices, notably fresh juices (Tables 1-3). In response to a large outbreak of food- borne illness attributed to apple juice in October 1996, FDA held a public meeting in December of that year to discuss the issues surrounding the safety of juice products. The Fresh Produce Subcommittee (FPS) of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) was in attendance. Afterwards, both the FPS and the full NACMCF met and made recommendations to FDA because of their safety concerns associated with juices. These recommendations included the implementation of HACCP with a 5-log reduction performance standard for the juice industry.
The next step was for FDA to develop a strategy on how best to address the incidence of foodborne illness related to the consumption of juices. The agency concluded that the NACMCF recommendations of HACCP with a 5-log reduction performance standard needed to be implemented with some interim interventions to address the problem until rulemaking could be completed for a HACCP regulation. This strategy consisted of the following three points: (1) Initiate rulemaking on a mandatory HACCP program for some or all juice products; (2) propose that the labels and labeling of some or all juice products not specifically processed to prevent or eliminate the presence of harmful bacteria bear a warning statement informing consumers of the risk of illness associated with consumption of the product; and (3) initiate educational programs to minimize the hazards associated with fresh juice. FDA immediately launched several education programs on juice as part of the food safety initiative. Subsequently the two proposals were published; one interim proposal for labeling and a HACCP proposal.
The first rulemaking to be finalized was the requirement that juice and juice products bear a warning label statement if the juice had not been treated to attain a 5-log reduction in the pertinent microorganism for a period at least as long as the shelf life of the product when stored under normal and moderate abuse conditions. The pertinent microorganism is the most resistant microorganism of public health significance that is likely to occur in the juice. The label statement reads as follows:
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 warning label is mainly an interim solution. The ultimate goal is that all juice be safe. HACCP is a vehicle to attain that goal.
Juice HACCP Proposal
On April 24, 1998, FDA proposed to require that juice processors apply HACCP principles to ensure the safe and sanitary processing of fruit and vegetable juices and juice products. In drafting the proposal, the agency took into account the NACMCF recommendations and existing HACCP regulations for seafood, meat and poultry. The agency invited interested persons to comment on the proposal.
One comment received in response to the juice HACCP proposal challenged a perception that the inside of intact citrus fruit could be sterile and that surface treatments would be adequate to make safe juice. Therefore, FDA researchers conducted studies on the effect of temperature differences on dye uptake by oranges and grapefruit and the potential for infiltration, growth and survival of Salmonella enterica serovar Hartford and Escherichia coli O157:H7 within oranges. In addition, information was gathered on the potential for infiltration, survival and growth of human pathogens within fruits and vegetables.
The NACMCF held a public meeting Dec. 8-9, 1999, to discuss the research and other information related to performance criteria for fresh citrus juices. The discussion centered around the potential internalization and survival of pathogens in citrus fruits and citrus juices and the application and measurement of the 5-log pathogen reduction standard to citrus fruit. The general consensus of the NACMCF was that: (1) the S-log reduction could begin with surface treatment of cleaned and specially culled citrus (i.e., undamaged, tree-picked fruit that is U.S. Department of Agriculture [USDA] choice or higher quality); (2) fruit and wash water temperatures needed to be controlled to minimize possible contamination; (3) the 5-log reduction must be done in one processing facility; (4) juice shipped in bulk must undergo a S-log reduction after transport and prior to final fill and packaging; and (5) if surface treatments were used to attain the 5- log reduction, process verification should include microbial testing of the final product.
While FDA was in the process of finalizing the HACCP rulemaking, several related initiatives were conducted. The first of these was two workshops during November 1998, to assist the “fresh” citrus juice industry in attaining the 5-log performance standard. FDA held another workshop to provide information for the apple cider industry. Three juice processors completed their participation in pilot programs with FDA. The National Center for Food Safety and Technology along with FDA was actively involved in research on juice processing technology.
Juice HACCP Final Rule
FDA published the juice HACCP final rule on Jan. 19, 2001. It requires that all juices and the juice ingredient in beverages be processed under HACCP as set forth in 21 CFR Part 120. Juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables, purees of the edible portions of one or more fruits or vegetables, or any concentrates of such liquid or puree. After the effective dates, juices not processed according to the regulation will be considered to be adulterated under section 402(a)(4) of the Food, Drug, and Cosmetic Act. The regulation applies to products in either interstate or intrastate commerce.
The time frame under which juice processors must comply with the regulation depends on the size of the firm. All firms except small and very small businesses must comply by Jan. 22, 2002. Small and very small businesses must comply by Jan. 21, 2003 or Jan. 20, 2004, respectively. Small businesses employ fewer than 500 persons (the same definition as used by the Small Business Administration). Very small businesses are defined as having either total annual sales of less than $500,000, or if their total annual sales are greater than $500,000 but their total food sales are less than $50,000; or the person claiming this exemption employed fewer than an average of 100 full-time equivalent employees and fewer than 100,000 units of juice were sold in the United States.
The final rule does not apply to harvesting, picking or transporting raw agricultural ingredients of juice products. It also does not apply to the operation of a retail establishment. Retail establishments provide juice directly to consumers and are addressed in FDA’s Food Code. However, juice processors that make juice that is sold both to other businesses as well as directly to consumers must use HACCP.
Juice processors must use the current Good Manufacturing Practices (GMPs) found in 21 CFR Part 110. In addition, they must have and implement sanitation standard operating procedures (SSOPs) that address: (1) safety of the water; (2) condition and cleanliness of food contact surfaces; (3) prevention of cross-contamination; (4) maintenance of hand washing/sanitizing and toilet facilities; (5) protection of food and materials from adulteration; (6) proper labeling, storage and use of toxic compounds; (7) control of employee health conditions; and (8) exclusion of pests. Juice processors must maintain SSOP records that document the monitoring and corrections related to the eight SSOP procedures.
Hazard Analysis and HACCP Plan
Juice processors must have a written hazard analysis. In conducting the hazard analysis processors first must identify all potential food hazards that occur in each particular juice they produce. These hazards may be biological, chemical or physical. The next step is to evaluate whether each potential hazard is reasonably likely to occur taking into account the frequency and severity of the hazard. Next processors must identify control measures for the hazards that are reasonably likely to occur. If the current process does not already control the hazard, the processor must determine what modifications are needed. Finally, processors must identify all CCPs in the process.
Once the CCPs are identified, processors must determine the critical limits that must be set at each CCP for the process to be under control. Each CCP must be monitored to ensure that the process is within the critical limits. When the process is outside of the critical limits, processors must take corrective actions. The minimum requirements for corrective actions are included in the regulation. The processor may have already considered some deviations from critical limits and then established a corrective action plan. Pre-planned corrective actions can save the processor time.
Verification and validation procedures are another significant step in HAG CR Verification is ensuring that the process is carried out according to the HACCP plan. Validation is ensuring that the HACCP plan is adequate to control the food safety hazards that are reasonably likely to occur. In the absence of a HACCP plan, validation is done to evaluate the adequacy of the hazard analysis.
A key consideration for requiring HACCP is recordkeeping. Records assist the industry to know what has occurred under their process and to project any trends toward deviations that could be occurring. Records assist FDA to know that the processor is adequately implementing its food safety controls. Processors must, at a minimum, keep the following records: (1) records documenting the implementation of the SSOPs; (2) the written hazard analysis; (3) the written HACCP plan; (4) records documenting the ongoing application of the HACCP plan; and (5) records documenting verification of the HACCP system and validation of the HACCP plan or hazard analysis.
Imported products pose a different situation because FDA does not generally inspect foreign facilities. Jurisdiction comes into place when products enter the country. During the seafood HACCP rulemaking, careful consideration was given to how an importer could show equivalency. The requirements for juice importers operate on the same principles.
The Performance Standard
As mentioned, the NACMCF recommended the use of a 5-log pathogen reduction performance standard for juice. FDA agreed with this standard because it targeted the main public health issue associated with juice: the presence of pathogens. It is the same standard that is required to avoid the warning label statement. There are some processes that provide a thermal kill many times greater than 5-log. These are low acid or acidified canned foods, shelf-stable juices and concentrates. Therefore, the regulation exempts these processors from the requirement for one or more CCPs for pathogen control in their HACCP plans, although they still must conduct a hazard analysis to determine if there are any chemical or physical hazards that are reasonably likely to occur in their product. Low acid and acidified canned food processors must file a process schedule with FDA under the regulations in Parts 113 and 114. Juice processors using a single thermal processing step sufficient to achieve shelf- stability of the juice or a thermal concentration process that includes thermal treatment of all ingredients must include a copy of the thermal process in their written hazard analysis if they are to claim the exemption.
All juice processors must meet the 5-log requirement through treatments that are applied directly to the juice, with the exception of citrus juice processors who may opt to use treatments on the fruit surfaces under very specific circumstances. All processors must start with cleaned and culled produce, but citrus juice processors using surface treatments must use undamaged tree-picked fruit that is USDA choice or higher in quality. The S-log reduction must be done, at a minimum, within a single production facility under GMPs just before or just after final product packaging.
Because of continuing questions about the possibility of pathogen internalization and because of the lack of alternative verification steps available for processors using surface treatments to achieve the 5-log reduction, periodic microbial testing to verify the effectiveness of the surface treatments is integral to the process control verification. Therefore, FDA is requiring juice processors that rely on surface treatments to test finished product for biotype I Escherichia coli.
Processors must randomly select samples for each 1,000 gallons of juice produced but not less than once every five working days. If a sample is determined to be positive for E. coli, the processor must check to see if the system if operating properly under the HACCP plan and correct any conditions that are not being met. These processors may opt to test for pathogens in addition to testing for E. coli. If two samples in any window of seven tests are positive for E. coli, the control measures used to attain the S-log reduction are inadequate and the processor must immediately use an alternate process (e.g., pasteurization) to achieve the S-log reduction until corrective actions are completed, and also perform a review of the monitoring records for control measures to attain the 5-log reduction standard.
If the review of the monitoring records shows that the HACCP plan was not being followed, then corrections must be made. If the review shows that the HACCP plan was being followed, then those aspects of the HACCP plan dealing with the 5-log reduction must be revalidated because the plan is inadequate to achieve the S-log reduction.
Plans are underway to provide training for FDA and state inspectors and for industry, particularly smaller processors. In addition, FDA intends to provide a juice HACCP hazards and controls guide that will assist juice processors in the development of their HACCP systems. The draft guidance will be available for public input before being finalized. All interested persons should comment. FDA is also receiving inquiries on the interpretation of the juice HACCP final rule. In response to these inquiries, FDA is developing a list of “questions and answers” that will be posted at www.cssan.fda.gov. As more companies implement HACCP, consumers will have greater assurance that the juice they drink is safe.
Shellee Anderson is a food technologist in the Office Plant and Daily Foods and Beverages of the U.S. Food and Drug Administration Center for Food Safety and Applied Nutrition, Washington, DC. In her 11-year career with FDA she has specialized in regulation writing, including the juice HACCP final rule.
U.S. Food and Drug Administration. Hazard Analysis and Critical Control Point (HACCP); Procedures for the Safe and Sanitary Processing and Importing of Juice; Final Rule. Federal Register 2001, (66)6137-6202.
U.S. Food and Drug Administration. Food Labeling: Warning and Notice Statement: Labeling of Juice Products; Final Rule. Federal Register 1998; 63(130):37029-56.