GGAP Applicable Regulations for HPSS

Transcription

1 GGAP Applicable Regulations for HPSS In auditing to GlobalG.A.P. standards the following federal, state, and local regulations must be considered; FDA FSMA Preventive Controls, FDA FSMA Produce Safety Rule, FDA FSMA Sanitary Transportation of Human and Animal Food, FDA CFR Title 21, Part 110, State Leafy Greens Guidelines such as LGMA California Leafy Greens Marketing Agreement, EPA federal regulations, USDA Pre-harvest Security Guidelines, USDA National Organic Program regulations. The following regulations are limited in scope and are only to be considered when appropriate: I. FSMA Preventive Controls for Human Food (PCHF): All food handling facilities that must register with FDA are required to meet the Preventive Controls regulations under FSMA. 2. FSMA Produce Safety Rule (PSR): All operations that produce raw agricultural commodities (RAC s) are subject to the Produce Safety Rule with the following exceptions: a. Produce that is rarely consumed raw (See Section (a)(1)). b. Crops that are subject to further processing with a validated process to eliminate spore forming microbes. (See Section (b)(1)) and meet the requirements of section FSMA Sanitary Transportation of Human and Animal Food: All farms are exempt. 4. State Leafy Greens Regulations (LGMA): There are different Leafy Greens regulations in each state so if you are auditing leafy greens know the regulations in the state the audit occurs. For our purposes I will utilize the LGMA (California Leafy Greens Marketing Agreement). LGMA Applies to Arugula, Cabbage, Chard, Escarole, Endive, Kale, Lettuce, Spinach, and Spring Mix grown in California. 5. USDA, NOP regulations (NOP) are to be applied to certified organic operations only with the exception of the manure rule, which has been adopted by the FDA for all operations required to follow the Produce Safety Rule. (NOP) The following regulations are applied for all growing operations in the United States: a. EPA regulations b. USDA Pre-harvest Security Guidelines (noted as guidelines ) c. FDA CFR Title 21, Part 110 for all handlers.

2 GlobalG.A.P HPSS Checklist: Question PSR (a) New hires trained upon hire and all employees annually. PSR (d) Employees must be retrained if not meeting standards. PSR All employees to be trained in Food Safety, hygiene, FDA standards under PSR Subparts C O as appropriate. All harvest crew to be trained to not harvest product that may be contaminated, hygienic handling of containers, and corrective actions. PSR (b) Training records must include; date of training, topics covered, and the personnel trained PSR (c) At least one supervisor must attend FDA recognized training PSR applies to contracted personnel Laboratories may be accredited by ISO Specific tests may utilize EPA, BAM, USDA, or AOAC methods. PSR (b) Microbial samples for E. coli must be via EPA Method 1603 or scientifically valid method that is at least equivalent PSR An annual inspection of the water delivery system will be conducted and documented PSR There must be no detectable E. coli in the following postharvest activities: a. food contact water b. water used on food contact surfaces c. food contact ice making d. hand-washing water Water used in growing crops must meet the following standards: a. No testing required for public water with certificate b. Geometric mean of less than 126 CFU/100 ml. for generic E. coli. c. Statistical Threshold Value (STV) of less than 410 CFU/100 ml. for generic E. coli, i.e. less than 10% of samples are above this value. d. initial sampling baseline established i. 20 samples taken in 2 4-year period for surface water

3 ii. 4 samples taken in one growing season for ground water. e. Ongoing testing required i. 5 samples per year for surface water ii. 1 sample per year for ground water. LGMA: (Note: All LGMA crops are subject to FSMA Produce Safety Rule so they must comply with the highest standard) Post-harvest water must either be treated with greater than 1 ppm free chlorine (ph ) or have no detectable E. coli. Growing water is described in LGMA Table #1: 1. Foliar contact water: a. rolling mean 126 CFU/100 ml. b. No samples over 235 CFU/100 ml. c. Water tested monthly during production 2. Non-Foliar contact water a. rolling mean 126 CFU/100 ml. b. No samples over 576 CFU/100 ml. The differences between the LGMA and the Produce Rule include: 1. Post-harvest water: No measureable E. coli allowed in either rule but in the LGMA there are specific requirements for treatment of water (1 ppm free chlorine with ph between ) while the Produce rule is not specific about how limits or treatment are achieved. 2. The LGMA has specific upper limits for any individual test result (no results over 235 MPN/100 ml for foliar contact) while the Produce Rule does not but instead relies on STV. 3. The LGMA relies on ongoing testing without building an initial sampling baseline PSR You must make visitors aware of policies and procedures to ensure that visitors comply with them Regulations for toilets vary by location. In California regulations are included in California Code of Regulations, Title 8, Section These regulations include: a. One portable per 20 employees. If over five employees are on site and both sexes represented male and female portables must be provided at the rate of one portable per twenty employees by sex.

4 b. Wastewater tank of at least 40 gallons that is fully contained. c. Portable must be clean, in good repair, made of readily cleanable smooth materials that are non-absorbent (no wood) and of light color. d. Must be within ¼ mile or 5 min. walk of work site. e. There must be written service records of cleaning and maintenance Hand wash water must be of U.S. EPA drinking water standards (no detectable coliforms) for all operations. This is mentioned in Produce Standard and LGMA specifically. There can be no detectable coliforms. If water source has detectable coliforms the hand wash water must be treated. In LGMA it requires treatment at the rate of at least 1 ppm. free chlorine (ph ) for treatment. In California Title 8, Section 3457 requires the following for handwashing stations. a. At least 15 gallons in water reserve. b. Readily accessible from portable toilet. c. Single-use towels for drying hands d. Soap PSR : Must have U.S. EPA drinking water standard running water, soap, hand drying method, & waste control of towels and grey water. Antiseptic hand rubs may not be substituted for hand-washing Industry standards vary by crop. It is typical to require non-latex disposable gloves for crops that have an edible outer surface touched by gloves. If re-useable gloves are used there must be monitoring and replacement procedures. Handlers: 21 CFR 110 Sec states gloves must be maintained in and intact, clean, and sanitary condition. The gloves should be of an impermeable material.

5 It is standard of practice that jewelry is not to be worn in harvest areas. Handlers: 21 CFR 110 Sec states that loose jewelry must be removed It is not typical of local regulations to require hair-nets. It is standard of practice in leafy greens harvesting and in-field processing operations such as coring, florets, etc. Handlers: In post-harvest handling hair-nets are standard of practice for all food handlers. 21 CFR 110 Sec states that effective hair restraints must be worn where appropriate. Identify if the employees are following documented company policies with respect to hair restraints All states have different requirements on application of agriculture chemicals. In California applications are regularly monitored by agriculture commissioners while in other states it is primarily complaint based. In California monthly Pesticide Use Reports (PUR s) must be submitted to the state while other states require records be maintained on site. The complete California Pesticide Regulations is available in California Code of Regulations (Title 3 Food and Agriculture) Division 6. Pesticides and Pest Control Operations. In California use of chemicals is regulated by California Department of Pesticide Regulation. See All personnel who apply chemicals must be trained or supervised by trained personnel. In California an applicator must either be a licensed as either a qualified applicator (QAL) or private applicator. See California Code of Regulations (Title 3 Food and Agriculture) FSMA Produce Rule requirements are described in above under water for growing crops. LGMA requirements are described in above under foliar contact water PSR states that water sources must a. You must annually inspect your water distribution systems, facilities, and equipment for the likelihood of introduction of reasonably foreseeable hazards. b. Water delivery systems must be maintained to prevent the water distribution system from becoming a source of

6 contamination. The following activities are the minimum standard; repairing openings in systems such as broken seals or well caps, preventing debris or domestic animals near water systems, and preventing pooled water near crops. (Note: The LGMA rules are similar to the above requirements.) See question The Produce Rule mirrors the USDA, NOP manure guidelines. It does not allow human waste except that it allows sewage sludge biosolids in accordance with the requirements of 40 CFR part 503, subpart D or its equivalent. The LGMA prohibits the use of uncomposted, incompletely composted, or non-thermally treated animal manure to fields for the growing of leafy greens. If they have been applied a one year waiting period must be observed prior to planting a crop of leafy greens... Incompletely composted green waste and biosolids are also prohibited See LGMA or PSR for standards for water from tanks. The standards are dependent upon the use of the water. Refer to LGMA Requires pre-harvest risk assessment within a week of harvest. The assessment must consider; animal intrusion, historical uses, adjacent land uses, and flooding. PSR No specifics on pre-harvest activities but take all measures reasonably necessary to identify, and not harvest, covered produce that is reasonably likely to be contaminated In the U.S. EPA drinking water regulations PSR (c) You must monitor water temperature that is appropriate for the commodity and operation and is adequate to minimize the potential for infiltration of microorganisms of public health significance. Where produce is immersed in water and has been shown to be susceptible to microbial infiltration from water, the water temperature differentials and time/depth of submersion during immersion should be controlled in accordance with current regulation, industry guidelines or best practices. For example, for tomatoes FDACS, USDA and the University of Florida GAPs require postharvest water be maintained at temperatures 10 ºF (5.6ºC) or

7 higher above the fruit pulp temperature and water temperature should be monitored at least hourly. These guidelines also require that tomatoes not be submerged in more than one foot of water for more than two minutes. (PrimusLabs Processing with HACCP audit guidelines, # 2.9.1) PSR You must not harvest dropped covered produce. Dropped covered produce does not include root crops, crops that grow on the ground such as melons, or crops that are intentionally dropped to the ground as part of harvesting (such as almonds) FSMA Preventive Controls for Human Food apply to all operations that must register with FDA. Supply Chain must be included in their Preventive Controls Plan. The Hazard Analysis must have addressed potential hazards originating from supply chain and all supply chain applied controls must be documented. Note: The hazard analysis must be completed by a PCQI (Preventive Controls Qualified Individual) who has completed a FDA approved training and received a certificate PSR (a) a water change schedule must be established for recirculated water to maintain its safety LGMA: Multiple-pass water systems must be treated with greater than or equal to 1 ppm free chlorine at ph between Continuous monitoring is preferred but periodic testing may be used if consistent results are obtained. FSMA Preventive Controls for Human Food Recirculated water system must have been identified in the Hazard Analysis and a Process Preventive Control must have been completed. The operation must be following the critical limits, monitoring, and corrective actions described in the Process Preventive Control Form and verification procedures must be documented. Note: The hazard analysis must be completed by a PCQI (Preventive Controls Qualified Individual) who has completed a FDA approved training and received a certificate FSMA The hazard analysis must identify Sanitation Controls where preventive controls are necessary. The sanitation controls must be documented, maintained, and verification procedures documented. Note: The hazard analysis must be completed by a PCQI (Preventive Controls Qualified Individual) who has completed a FDA approved training and received a certificate.

8 5.5.4 FSMA The hazard analysis must identify all Allergen hazards requiring a preventive control. The allergen preventive controls must identify the types of allergens, parameters, monitoring requirements, & labeling requirements. All documentation of allergen control activities and verification procedures must be available for review. Note: The hazard analysis must be completed by a PCQI (Preventive Controls Qualified Individual) who has completed a FDA approved training and received a certificate FDA Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh Cut Fruits and Vegetables. Fresh cut melons and other fresh cut product must be kept at or below 41 F (5 C) PSR (a)(3) There must be no detectable E. coli in 100 ml. of water used to make ice Refer to Refer to See USDA Pre-Harvest Security Guidelines