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Evaluation of alternatives and variances under 21 CFR 112 (Alternatives,…

- - - - 2. Unique considerations for public health
        
        3. Competency of individuals conducting evaluation
        
        4. Proper documentation
        
        Farm using alternative measure must establish and maintain documentation of scientific data and information on which farm relied to use alternative measure (112.12)
      - E.g., alternative microbial die-off rate and accompanying max time interval (112.49(b)) should consider:
        
        microbial characteristics
        
        environmental factors (sun intensity, moisutre level, temp, pH, presence of competitive microbes, preciptiation, crop type, timing of water application, and frequency of water use)
        
        "Any microbial quality standard used in lieu of the microbial quality criteria in S. 112.44(b) should be supported by an equally robust and rigorous scientific analysis and be quantitatively demonstrated to be equivalent to the FDA-established criteria" (p.9 of DG on Consid.)
      - Use of alternative microbial quality criterion (or criteria) using an appropriate indicator of fecal contamination in lieu of FDA-est. microbial quality criteria (S. 112.49(a) based on E. coli). Any alternative indicator to generic E. coli should be AS SENSITIVE to presence of level of fecal pollution
        See PSR 80 FR 74354 at 74416
        
        See FDA Fact Sheet, PSR (21 CFR 112), "Equivalent Testing Methodology for Agricultural Water
- - - - 2. Unique considerations for public health
        
        3. Competency of individuals conducting evaluation
        
        4. Proper documentation
        
        Petition must include "Statement of Grounds" that influces info supporting variance request (112.173)
        
        FDA will make petitions submitted to FDA, public comments received on those petitions, and conclusions of FDA evaluations publicly available. (S. 112.176(d))
        
        Can a CA show that meeting certain requirements of part 112 would be problematic in light of local growing conditions? (Apply variance to some or all provisions of part 112)
        
        To support conclusion, CA might consider the:
        
        historical performance of industry within jdx
        i. based on epidemiological record
        
        combination of measures taken by industry
        
        Can foreign country show that different log pathogen reduction could be deemed adequate to control risk presented to human health from exposure to specific hazard?
- - - - Common questions to ask for all SLPHP determinations:
        
        Are the relevant data and information in support of the use of a measure SUFFICIENT to make a determination that the measure provides the "same level of public health protection" as the corresponding requirement?
        
        Considerations:
        A. Rigor and robustness of data and factual info
        
        methodology (study design, sample sizes, statistical significance, range of variables)
        B. Accompanying risk assessment (potentially)
        
        When conducted "preferred that it's based on appropriate methodology and is as robust as FDA's risk assessment
        
        I. For QUANTITATIVE requirements, in which FDA:
        1) determined certain quantitative and prescriptive measures are necessary to help ensure food safety
        AND
        2) specified relevant numerical criteria,
        Use of measure should achieve any specified numerical criteria associated with PHP underlying corresponding requirement.
        
        Includes:
        
        Rates of illness
        i. FDA considered EPA's analsysis of data describing specific illness rates on bodies of recreational water and WHO's recommendations for protective measures and preventive measures to reach necessary total log reduction of pathogens to achieve a specified target health outcome
        See discussion at 80 FR 74416
        
        Level(s) of risk reduction OR established log reduction of pathogen levels
        
        1 more item...
        
        I. For QUALITATIVE REQUIREMENTS:
        
        they're inherently flexible and allow use of different measures
        
        Ex: PSR requirement about equipment and tools of "adequate design, construction, and workmanship to enable them to be ADEQUATELY cleaned and properly maintained" (S. 112.123(a))
        
        SLPHP evaluation likely NOT necessary re: qualitative requirements because farm or facility should be able to use practices, procedures, or processes well-suited for its own operations and commodities
        :forbidden:
        
        FOR ALL EVALUATIONS:
        
        conclusions should be based on consideration of ALL reasonably available and relevant data
        
        Are there any unique considerations relevant to level of public health protection provided by that measure?
        
        Considerations:
        
        Is hazard or adverse health effect intended to be addressed by req. being adequately controlled through other measures during production or at a different point in the supply chain?
        (esp. for facilities and FSVPs addressing foreign supplier's compliance with PC rule)
        
        Are there circumstances where it may be demonstrated that a required process, procedure, or practice is not necessary because of local growing or production environments?
        
        Relevance of SLPHP determinations
        
        i. Data/info may support the use of a measure specific to a commodity, condition, or practice that can THEN be appropriately applied to other commodities, conditions or practices
        ii. S. 112.177, specifying conditions under which approved variance may apply to persons other than those identified in petition requesting variance
        
        Threshold for SLPHP is likely to be met where the measure reflects a more stringent or restrictive requirement than the corresponding FDA requirement addressing the same standard. (e.g. in case of foreign country.)
        
        Was the evaluation of scientific and technical evidence conducted by competent individuals using an appropriate process?
        
        Who may conduct an SLPHP evaluation?
        
        FDA (w/r/t variance requests)
        
        CA of state, tribe, or foreign country
        
        individual farm or facility
        
        importer
        
        trade or other association
        
        private food safety scheme
        
        other stakeholder
        
        Regardless of entity, process should ensure sufficient knowledge and technical expertise of individuals conducting evaluation.
        
        Process-related considerations less important (maybe) for quantitative requirements where an SLPHP determination is driven by specified objective outcomes and, therefore, likely less dependent on the judgment of individuals conducting the evaluation. (But evaluation still needs to be conducted by a competent individual)
        
        Output should be:
        
        Adequate
        
        Accurate
        
        current
        
        reliable
        
        Conducted in objective manner by qualified experts (based on education, experience OR training (or combo))
        
        Should be revisted (as necessary).
        When:
        
        relevant and new scientific or technical evidence indicates that measure is not as effective as previously demonstrated or additional controls are necessary
        
        As FDA is aware of such new info, it will try to share it with relevant stakeholders and (as warranted) conduct reanalysis of affected prior SLPHP determinations
        
        If signficant changes in farm or facility's infrastructure or production practices that affect nature of associated hazards or level of risk
        
        Is the determination of SLPHP properly documented?
        
        Document ALL relevant SLPHP evaluation evaluation
        
        FDA intends to disseminate useful info (wehn available) to help industry apply new scientific or other info to their operations