|Food Safety and Inspection
United States Department of Agriculture
Washington, D.C. 20250-3700
Set out below are responses to various questions raised at the first Technical Conference. In a number of instances, a specific response will depend upon the circumstances in a particular case. As FSIS moves from prescriptive requirements to standards that provide flexibility on how to achieve compliance, the frequency with which consideration of particular circumstances is necessary is likely to increase.
FSIS has provided information about its regulatory requirements and how to comply with them in the preamble to the Pathogen Reduction-HACCP Systems rule and other final rules, in Federal Register notices published to ensure public awareness of the Agency's position on regulatory requirements, and in Agency guidance materials.
Agency personnel responsible for determining whether there has been a failure to comply with one or more regulatory requirements, and if so, what action to take, will need to consult FSIS Directives 5000.1 and 5400.5.
What is the agency's definition of "receipt" of product?
When is a product considered to have been "received" by an establishment, and what are the implications of rejecting product at the point of "receiving" in a HACCP plant?
The HACCP system regulations do not use the quoted terms. Part 417 does require that hazard analyses consider food safety hazards that can occur before (as well as during or after) entry into the establishment, and a plan's CCP's must include ones that are designed to address any such hazards that are reasonably likely to occur (§§ 417.2(a)(1) and (c)(2)(ii)). It is the establishment's responsibility to determine the CCP's for each identified hazard--that is, the points, steps, and procedures in its processes at which the establishment can apply control and, as a result, prevent, eliminate, or reduce to acceptable levels the hazard (§ 417.1).
The implications of rejecting product depend upon who is rejecting what, where, and for what reason. For example, establishment rejection of an ingredient might mean that a HACCP plan is operating effectively to control the entry of an ingredient that does not accord with establishment specifications. (See FSIS's generic HACCP models for specific examples. For what a HACCP plan's critical limits must be designed to ensure, see § 417.2(c)(3), addressed in the response to the next question.)
Also, FSIS's regulations require that when a consignee refuses to accept delivery of a product that bears an official inspection legend on the grounds that it is adulterated or misbranded, the consignee must notify the Agency of the kind, quantity, source, and location of the product and the respects in which the consignee alleges that it is adulterated or misbranded (§§ 320.7 and 381.181). Finally for regulations that do address product receipt, see §§ 318.1 through 318.3 and 381.145 and the recordkeeping requirements in §§ 320.1(b)(1) and 381.175(b)(1).
If a plant produces product that is fully cooked, ready to eat and sells it directly to a second plant that includes the product in a not ready to eat product that is labeled with validated cooking instructions, why is this product subject to the Agency's microbiological monitoring program?
FSIS samples products to verify compliance with safety standards and other regulatory requirements. (Applicable regulations include §§ 318.2(c), 318.9, 381.145(b), 381.146, and 417.8(g).) For some time, FSIS sampling activities have included testing for microbiological contaminants.
Periodically, FSIS reviews its sampling activities and considers changes to increase their contribution to programmatic objectives. The Agency expects to make additional changes to improve the usefulness of microbiological sampling as a verification activity in establishments operating under HACCP systems, and it will consider the question raised at the Technical Conference as it develops these modifications. However, FSIS will continue to sample a range of products, both ready-to-eat and not ready-to-eat, in appropriate circumstances.
FSIS has recognized differences among products depending upon whether they are or are not ready-to-eat. For example, when the Agency amended the production requirements for certain meat food and poultry products this past January, it did not subject partially cooked products to a lethality performance standard (64 FR 732, 733-34). (FSIS did apply the same stabilization performance standard requirements to both ready-to-eat and not ready-to-eat products.) Moreover, part 417 requires that a HACCP plan list critical limits that, at a minimum, are designed to ensure that requirements pertaining to the specific process or product are met (§ 417.2(c)(3)).
Establishments may wish to tailor their production practices to reflect differences in the applicable regulatory requirements. For example, an establishment that produces product for use as an ingredient in other establishment's meat food products may wish to identify the product as not ready-to-eat, even though the second establishment's purchase specifications might support its treatment as a fully cooked product.
How can industry gain on-line access to acquire reprints from the National Agriculture Library? The purpose for doing this would be to collect information that could be used to document a HACCP plan.
In light of copyright restrictions, the National Agriculture Library (like other libraries) limits on-line access to abstracts or summaries of journal articles. Industry members may obtain a photocopy of the article itself through public libraries, which generally access journals to which they do not subscribe through an interlibrary loan program.
To facilitate requests for photocopies of articles referenced in FSIS guidance materials, the Agency will, in the future, try to provide the National Agriculture Library catalogue number (NAL Call No.) as well as the journal citation.
It was proposed that since the Agency assumes that meat and poultry products contain 104 Clostridium perfringen spores, the stabilization performance standard be changed to no more than 1 log increase in Clostridium perfringens or to no more than a total of 104.
As amended this past January, the production requirements for certain products include performance standards that (among other things) limit multiplication of Clostridium perfringens to a maximum of 1 log 1010 within the product (§§ 318.17(a)(2), 318.23(c)(1), and 381.150(a)(2); 64 FR 744-46). FSIS determined that this limit is appropriate to ensure there will be no more than 105 Clostridium perfringens per gram on the finished product after cooling (64 FR 738) using Center for Disease Control criteria, but the Agency did not prescribe how an establishment achieves compliance with the stabilization performance standard (no more than a 1 log 1010 multiplication of Clostridium perfringens within the product). Thus, for example, an establishment might elect to rely on other scientific and technical sources and develop and validate procedures, as part of its HACCP system, that are based on growth curves for vegetative cells or the outgrowth of Clostridium perfringen spores.
If industry members believe that an alternative stabilization performance standard would achieve the same level of public health protection, FSIS recommends that they petition the Agency, and provide supporting data, to amend the regulations. The Agency expects to initiate another rulemaking on ready-to-eat products in 2000 and could respond in that rulemaking.
When can USDA regulations, policies, etc. be considered "safe harbors" and when can they not be considered "safe harbors".
With one possible exception, the term "safe harbor" is not an appropriate characterization of FSIS actions. That is why FSIS no longer uses this term. FSIS regularly provides guidance on the types of procedures and practices that industry members may choose to use to achieve compliance with specific Agency regulations. For example, when FSIS replaces prescriptive requirements with a performance standard, the Agency may believe that, under appropriate controls, one can achieve compliance with the performance standard by following the replaced prescriptive provisions, with or without modifications.
The possible exception, specified in § 417.2(b)(3), is for food safety hazards associated with microbiological contamination: HACCP plans for thermally processed/commercially sterile products that are produced in accordance with the current canning regulations--part 318, subpart G, or part 381, subpart X--need not, at this time, address microbial hazards. (FSIS intends to convert these regulations to performance standards.) HACCP plans must address all other food safety hazards that are reasonably likely to occur in the production process, and when FSIS regulations include pertinent requirements, plans must (among other things) list critical limits that are designed to ensure that these requirements are met (§ 417.2(c)(3)).
When FSIS has issued guidance, it is not likely to raise concerns about HACCP plan procedures that are based on that guidance. However, firms should recognize that materials other than regulations are not binding. FSIS is free to withdraw guidance, without any advance notice or other process, based on newly available information or reanalysis of existing information. This underscores the importance of establishment validation, which is addressed in the response to the next question.
If an establishment uses safe harbors, what is required as far as in-plant data for validation?
As noted above, "safe harbor" is not really an appropriate characterization of FSIS actions. For initial validation, § 417.4(a)(1) requires an establishment that is subject to the HACCP system regulations to "conduct activities designed to determine that the HACCP plan is functioning as intended." During a plan validation period, the establishment "repeatedly test[s] the adequacy of the CCP's, critical limits, monitoring and recordkeeping procedures, and corrective actions" and reviews of records generated by the HACCP system.
The specifics depend upon the situation, including the particular process and establishment factors. As FSIS explained in the Pathogen Reduction-HACCP Systems final rule (61 FR 38826), an important element of validation is the identification or development of data that show that the establishment can apply the process or control to get the anticipated effect under actual in-plant operational conditions. FSIS guidance may indicate the theoretical soundness of a well-established technology as it has generally been applied, but this does not constitute a demonstration of a particular establishment's ability to implement the technology and make it work. (See response below regarding industry's responsibility for validation.)
In some situations, establishments will be able to utilize their experience prior to the application of the HACCP system regulations in developing and validating their HACCP plans. For example, the results of monitoring conducted under a partial quality control program may be used in substantiating the establishment's ability to comply with a performance standard and provide monitoring procedures and verification activities that the establishment can incorporate into a HACCP plan. Similarly, an establishment may have data on its success in applying FSIS guidelines to achieve compliance with the lethality performance standard for roast beef. (See § 318.17(a)(1) and the compliance guidelines that FSIS issued in January (64 FR 732).)
What was the original intent of the statement "...in the absence of those controls..." in the PR/HACCP final rule (417.2a)).
Both the NACMCF document and the PR/HACCP regulation include the phrase "in absence of its control" as part of the definition of a hazard (417.2). How does this relate to the use of data documented from prerequisite programs, and how might it be used in reassessment?
In paragraph (a)(1) of § 417.2, FSIS sought to clarify when a food safety hazard is "reasonably likely to occur" in the production process by stating two alternative bases for such a determination. They are: (1) the hazard historically has occurred, or (2) in the absence of preventive measures to control the hazard, there is a reasonable possibility that the hazard will occur in the particular type of product.
The second basis recognizes, among other things, that one may not have documented occurrences of a hazard because the hazard is one that is well-recognized and well-characterized, and preventive control measures are readily available and generally used. For example, establishments that temper (thaw) frozen meat prior to utilizing it in the production of meat food products would consider it irresponsible to do so by letting the meat sit in combo bins or other containers on the production floor or in another unrefrigerated area. Industry members recognize that without a cooling source, pathogens will grow during the thawing process. Therefore, they temper the meat in running water or a cool water bath, or they place it in a cooler to defrost. In other words, they have adopted preventive control measures.
The HACCP system regulations do not define "hazard" in terms of controls, and no other part 417 regulation includes the phrase quoted in the second question. For purposes of part 417, § 417.1 defines "food safety hazard" and "hazard" as "[a]ny biological, chemical, or physical property that may cause a food to be unsafe for human consumption."
Part 417 does not limit the sources of data used in a hazard analysis or in plan reassessment. However, data on an establishment's success in implementing procedures that control a food safety hazard do not indicate that the hazard is not reasonably likely to occur; in fact, such data more logically support the opposite conclusion (that is, indicate the need for control). The controls and other features required by part 417 must be in a HACCP plan. Data on establishment activities that are not incorporated in a HACCP plan do not excuse noncompliance with part 417 requirements.
Provide clarification regarding hazard analysis documentation, particularly in regard to prerequisite programs and how the prerequisite programs can be used to support a hazard not being likely to occur.
Provide clarification on how the determination is made as to whether something belongs in a prerequisite program or in a HACCP plan.
Paragraph (a) of § 417.5 specifies the records that an establishment must maintain to document a HACCP plan. Among these are "[t]he written hazard analysis prescribed in § 417.2(a)..., including all supporting documentation" (§ 417.5(a)(1)). The hazard analysis on which a plan rests must "include food safety hazards that can occur before, during, and after entry into the establishment" (§ 417.2(a)(1)).
Part 417 requires that a HACCP plan be a self-contained document. The existence of other establishment activities does not excuse failure to comply with part 417 requirements. In other words, "the Agency does not view references to good manufacturing practices, or establishment actions in accordance with good manufacturing practices, as satisfying the requirements for the contents of a HACCP plan" (63 FR 4562, January 30, 1998).
Similarly, when FSIS issued the Pathogen Reduction-HACCP Systems final rule (61 FR 38834), the Agency noted the importance of Sanitation SOP's as tools for meeting existing sanitation responsibilities and preventing direct product contamination or adulteration and their appropriateness as near-term procedures--that is, for implementation prior to HACCP implementation. In that sense, Sanitation SOP's are a prerequisite to HACCP.
Nevertheless, once part 417 applies, HACCP plans must address each food safety hazard that is reasonably likely to occur in the production process. Claiming that Sanitation SOP's adequately deal with such a hazard would not suffice. (See also FSIS's Federal Register notice on Listeria monocytogenes contamination of ready-to-eat products (64 FR 28351, May 26, 1999).) As explained above, by providing that a food safety hazard is "reasonably likely to occur" in the production process if, in the absence of preventive measures to control the hazard, there is a reasonable possibility that the hazard will occur in the particular type of product, § 417.2(a)(1) recognizes that due to controls already in place, one may not have documented occurrences of a hazard.
Thus, existing establishment programs may facilitate development and implementation of a HACCP plan. Suppose, for example, an establishment has been controlling microbial growth and proliferation by temperature and time specifications for carcass parts held in the cooler prior to processing. In recent scientific studies, the organisms of concern are controlled or reduced at the specific temperature over a specific time. The establishment can use this information along with results showing effective implementation of the practice for validation and as a basis for selecting monitoring procedures.
If a plant has set a critical limit and has operated for several years without a deviation, can the establishment use that data to eliminate the CCP through reassessment of their HACCP plan?
The HACCP system regulations require that HACCP plans address each food safety hazard that is reasonably likely to occur in the production process. The fact that there has not been a deviation from a critical limit for several years would not, in and of itself, imply that there is no need for a CCP. The absence of deviations could simply be evidence of the effectiveness of an establishment's preventive controls.
Clarify the difference between a potential hazard that is listed during the hazard analysis and a food safety hazard that is addressed in the HACCP plan. This will help address confusion that all potential hazards must be addressed in the HACCP plan.
The regulations require, in § 417.2(a), that a hazard analysis "include food safety hazards that can occur before, during, and after entry into the establishment." The purpose of the analysis is to "determine which of these are reasonably likely to occur in the production process and identify the preventive measures the establishment can apply to control" them. The regulations do not require that an establishment HACCP plan control hazards not identified as reasonably likely to occur in a production process.
Why has all the burden for validation been placed on industry?
Industry is responsible for complying with regulatory requirements. Validation of a HACCP plan in the particular circumstances of a specific location is essential to an establishment's conclusion that the plan can adequately control food safety hazards identified during the hazard analysis. Only the establishment can show that it can apply a process or control to get an anticipated effect under actual in-plant operational conditions (61 FR 38826).
FSIS does provide guidance materials that assist industry members in satisfying validation requirements. For example, FSIS might conclude that the potential effectiveness of a technology has been established, based on generally available scientific information. Establishment validation then would provide the practical data or information, reflecting the establishment's implementation experience, that demonstrates that the particular establishment can implement the technology and make it work.
Where is the agency's validation of recently mandated CCP's (e.g., zero tolerance)?
FSIS has not and does not mandate CCP's. Instead, the Agency verifies the adequacy of HACCP plans by determining that they meet the HACCP system requirements and other applicable regulations (§ 417.8) and makes determinations about the adequacy of HACCP systems (§ 417.6). When discussions with industry members or questions from Agency personnel indicate the need to clarify what the regulations require or what types of actions would constitute compliance, FSIS provides guidance.
FSIS published a Federal Register notice to ensure that establishment owners and operators were aware that the Agency regards its "zero tolerance" for visible fecal material as a food safety standard. Because fecal material is a vehicle for microbial pathogens, and microbiological contamination is a food safety hazard that is reasonably likely to occur in the slaughter production process, HACCP plan controls for microbiological contamination at slaughter must be designed to achieve compliance with this standard.
Provide information on other options available for foreign material detection because detection systems may be cost prohibitive (e.g., checklists).
FSIS provided guidance on several methods for controlling physical hazards in the draft generic HACCP models and is doing so in the revised versions that are now becoming available. The methods include visual examination of incoming product, purchase specifications, and discontinuing use of suppliers that do not meet criteria. Obviously, the hazard to be controlled, and the point in the process at which the hazard may occur, affect method selection. Easily detected materials such as broken needles may lend themselves to visual examination of incoming product. Other methods are better suited for controlling in-process hazards from equipment malfunction or non-maintenance. For example, processors can check grinder blades at the start of each shift to ensure that there are no chips or cracks and have continuous maintenance checks. Depending on the circumstances, appropriate corrective actions for deviations from critical limits might include the use of rented x-ray equipment, visual examination of 100% of affected product, or condemnation. Rigorous hazard analysis and the use of effective critical limits and verification procedures appear even more important when less technically sophisticated methods are used to control physical hazards.
Is there a "no glass" policy that can be shared with the very small plants?
FSIS determines whether a food is adulterated due to the presence of glass on a case-by-case basis.
Manufacturers producing products such as baby food, or other products, in glass jars need to address the potential hazards inherent in the use of such containers. In such operations, a food safety hazard appears to be more likely than in an establishment where the potential hazard is from such sources as glass contaminants of nonmeat ingredients. FSIS's generic HACCP models include some options as to when glass could pose a food safety hazard reasonably likely to occur in the production process and some alternatives for critical limits, verification procedures, and corrective actions.
How can the expansion of the HACCP roundtable concept that is used by Agricultural Extension Service personnel with the small and very small plants (i.e., Ohio, Arkansas) be encouraged on a nationwide basis?
FSIS has encouraged the Contact/Coordinator network that is utilized throughout the states and territories to use all the tools at its disposal to reach very small plants with HACCP information. The Small Plant Office holds conference calls with network participants on a regular basis. All information provided to small and very small plants is provided to the contact/coordinators, along with additional resources to assist them in reaching as many plants as possible. Other round table-type activities are occurring throughout the country, including in California, Tennessee, North Carolina, and other states.
The National Small Plant Office will continue to provide guidance and assistance to all efforts directed at assuring that very small plants receive the information they need for timely implementation of HACCP plans. The most important goal is that each plant is afforded an opportunity to obtain the information necessary to implement HACCP successfully. Guidance and assistance can take many forms, and the diversity of approaches taken by the national network should be applauded. FSIS knows that, particularly with very small plants, "one size does not fit all."
For Further Information Contact:
FSIS Constituent Affairs Program
Phone: (202) 720-8594
Fax: (202) 720-5704
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