Record Requirements

 

This is only a summary of the records as stated in the Produce Safety Rule.
– To see all requirements of the rule in its entirety, please refer to the Code of Federal Regulations 21 CFR Part 112.
– For templates and clarification, please see Cornell University’s Produce Safety Alliance

Click to jump to a Topic Heading:
General Requirements
Worker Health, Hygiene and Training
Soil Amendments
Wildlife, Domesticated Animals, and Land Use 
Agricultural Water Part 1: Production (Growing) Water
Agricultural Water Part 2: Postharvest (Harvest and postharvest) Water
Postharvest Handling and Sanitation
Commercial Processing Exemption
Qualified Exemption

General Requirements: All records must have:

1) Name and location of farm (112.161(a)(1)(i))
2) What task was done (if form allows for more than one action)
3) Date and time of task (112.161(a)(1)(v))
4) Description (lot #, commodity name, identifier) of covered produce being affected (112.161(a)(1)(iii)
5) Location of area affected (field, packing house, bathroom) 112.161(a)(1)(iv)
6) Any materials/observations/values/conclusions relevant to task (112.161(a)(1)(ii))
7) Date and Signature/initial of the worker* who conducted activity (112.161)(a)(4))

*Date and Signature of supervisor or food safety plan advisor required for:

1) Records for eligibility of qualified exemption, including annual review and verification of farm’s continued eligibility (112.2(b) – records and compliance with commercial killing step documentation or 112.5 (average food income less than $500,000 (per inflation) over last 3 years and sell more than half in average annual monetary value of food to qualified end users (consumers, restaurants, grocery stores) than other buyers) (112.7(b)) sales receipts do not require signature or initials.
2) Records related to required training of personnel, including date of training, topics covered and individual(s) trained. (112.30)(b)
3) Documents related to the results of all analytical tests conducted on agricultural water for the purposes of compliance (112.50(b)(2) (Microbial Water Quality Plan – Generic E.coli, GM < 126CFU/100mL and STV <410 CFU/100mL or No detection)
4) Documents related to the results of water treatment monitoring (certificate of compliance with Safe Water Drinking Act for public treated water or sanitizing of water as under 112.43(b)). (112.50(b)(4))
5) Documents related to the actions taken to remedy 112.45 (What happens if my agricultural water does not meet microbial standards or is contaminated?) as related to your water system and your affected covered produce. (112.50(b)(6))
6) Records related to process controls for treating biological soil amendments of animal origins you produce for your own covered farm (112.60(b)(2)) (process controls of selected approved method, including documented achievement of required temp, time, turnings, etc)
7) Records of cleaning and sanitizing equipment (112.140(b)(1) and (2) (equipment, tools, buildings and transportation in contact with covered produce or related to covered harvesting, packing or holding activities and for the growing operations for sprouts)

Sprouts

8) Records documenting your treatment of seeds or beans to reduce microorganisms of public health significance in the seeds or beans, at your farm, or records of documentation (ex. Certificate of conformance) from seed supplier that seeds or beans are treated to reduce microorganisms of public health significance and are appropriately handled and packaged following treating as in 112.142(e)) (112.150(b)(1)
9) Records documenting the results of all analytical tests conducted for purposes of compliance with Subpart M (Sprouts) (112.150(b)(6) (E.coli 0157:H7, salmonella, other, listeria).
10) Record documenting actions for 112.142(b) (beans or seeds contaminated with a pathogen), (c) contamination shown only through microbial tests and source was not seeds or beans; 112.146 (environmental positive for listeria); 112.148 (spent sprout irrigation water or sprouts test positive for E.coli O157:H7, salmonella, other) ) 112.150(b)(6)

Results of water treatment monitoring

– Records must be created at time of activity performed or observed (112.161(a)(2))
– Accurate, legible, and in ink  (112.161)(a)(3)

Worker Health, Hygiene and Training

112.30 (a) and (b) – Records be kept according to the requirements in subpart O and include date of training, topics covered, and individual(s) trained.

Topics must include:

112.22(a)(1): principles of food hygiene and food safety
112.22(b):
1) Recognizing covered produce that must not be harvested, including covered produce that may be contaminated with known or reasonably foreseeable hazards
2) Inspecting harvest containers and equipment to ensure that they are functioning properly, clean, and maintained so as not to become a source of contamination of covered produce with known or reasonably foreseeable hazards
3) Correcting problems with harvest containers or equipment, or reporting such problems to the superior (or other responsible party) as appropriate to the person’s job responsibilities.

Other records include:

– facility monitoring (cleaning/stocking of toilets, handwashing facilities, first aid kits)
– worker illness and injury reporting

Subpart O (112.161-112.167)

all records required must (unless otherwise stated):
1) Include (as applicable):
               i) Name and location of farm
               ii) Actual values and observations obtained while monitoring
               iii) Adequate description of covered produce applicable to the record
               iv) Location of growing area or other area applicable to the record
               v) Date and Time of activity documented

2) Records satisfying 112.30(b) worker health, hygiene and training must be reviewed, dated, and signed within a reasonable time after records are made by supervisor or responsible party (112.161(b)).

Soil Amendments

Recordkeeping to monitor soil amendment application

– type and source of soil amendment
– rates and dates of application (compared to harvesting)
– handling and sanitation practices used to reduce risks

112.60 – Recordkeeping to monitor soil amendment treatment* (process controls)
*comment 145 – FDA does not intent 112.55 (microbial standard 1) listeria not detected with less than 1 CFU/5g or mL sample; and 2) salmonella not detected with less than 3 most probable mean per 4g or mL sample; and 3) E. coli O157:H7 not detected less than 0.3 MPN per 1g or mL sample; OR salmonella not detected with less than 3 most probable mean per 4g or mL sample; and less than 1000 MPN fecal coliforms per g or mL sample) to require that farms test their treated biological soil amendments for compliance with the microbial standards. Rather, FDA intends these provisions to provide the standards against which treatment processes described in 112.54 (aerated static composting and turned composting) must be validated. Farms would be able to use treatment processes that are validated to meet the relevant microbial standard in 112.55 without the need to test the end products of their treatments to confirm that the microbial standard was achieved.
– length of time materials were composted
– the temperature compost reaches (included come-up time)
– turnings (how often)
– other processing steps to show selected validated process has been done correctly

112.52(a) – Biological soil amendments supplied by a third party provider for
– name and address of the supplier
– what soil amendments were purchased
– date and amount purchased
– lot information (if possible)
– documentation showing supplier has used scientifically validated treatment processes and monitoring (proper time and temperature 112.54) during the production of the treated amendment (including compost)
– documentation showing supplier conducted proper handling and storage of treated amendment while on supplier grounds (Avoid recontamination, etc) 
– (last 2 points could be a certificate of conformance)

112.60(b)(1) same as above for biological soil amendments of animal origin and must be renewed annually.

(not required for farms, but suggested. Required for sprouts)

Written corrective action plan.
– outline steps if soil amendments
 a) pose a microbial risk to the crop
 b) were improperly treated
 c) accidentally contacted the harvestable portion of the crop
 d) options for contaminated produce (kill step, composting, disposal etc)

Wildlife, Domesticated Animals, and Land Use
(none required except previously stated worker training)

(recommended)
i) Preplant land assessment
ii) Monitoring for animal activity
iii) Actions taken to reduce the risks related to animal intrusion into crop (domesticated and wild)
iv) Pre-harvest risk assessments:
– document if any fecal contamination is present or signs indicating a risk
– if fresh produce has been contaminated and cannot be harvested
– corrective actions (no harvest buffer zones) etc.
v) Written SOP for if animal poops when in the field growing covered produce
– do not harvest any produce that may be or is contaminated
– determine if no bugger zones around the contamination are sufficient to reduce risk to allow harvest of the uncontaminated produce (0-25ft depends on future rain/wind, amount of poop, and extensiveness/spread of problem )
– other corrective actions (removal + sanitation, bury + sanitation, etc)
– what to do with produce (remove, leave, bury, etc)
– document all preventative actions (more monitoring, deterrence, corrective actions)
vi) all corrective actions taken

Agricultural Water Part 1: Production (Growing) water ***Currently under Revision by FDA

112.42(a) Findings of annual or more frequent inspections of water system

112.46 (b) Microbial Water Quality Plan
– Untreated Ground water Testing Requirements
112.46(b)(1)(i)(B) initially – 4 or more times during the growing season or over the period of a year as close to harvest as possible
112.46(b)(2)(i)(B) annually – 1 or more samples rolled into profile every year
112.46(b)(2)(iii) GM and STV must be calculated with current year + 4 previous years (if possible) to make up a rolling data set of at least 4 samples (at least 1 per year)

– Untreated Surface Water Testing Requirements
112.46(b)(1)(i)(A) initially – 20 or more times over a period of 2-4 years
112.46(b)(1)(ii) – samples be prior to harvest
112.46(b)(2)(i)(A) annually – 5 or more new samples rolled into profile every year
                                             GM and STV must be calculated with current year + previous 4 years (if   possible) to make up a rolling data set of at least 20 samples (at least 5 per year)

112.46(b) – each water source must be tested to establish the initial profile and the annual samples to update the prole for each sample.*
   – using ground water as agricultural water, then storing ground water in a pond and then using the pong water as agricultural water turns that stored water into surface water and requires a whole new MWQP.

112.46(b)(3) ~MWQP must be restarted if water quality profile no longer represents the quality of the water source

112.44 Geometric Mean and Statistical Threshold Value of generic E.coli tests (measured in CFU/100mL water)
Goal: 126 or less CFU generic E.coli / 100mL water AND 410 or less CFU generic E.coli/100mL water

$30-50 per test (cost, location, protocol or special materials needed, turn around time, results format, funding?)

Approved methods for production AND harvest/postharvest agricultural water (40 CRF 136.3) for generic E.coli

Membrane filtration (units: CFU/100mL)
1) EPA Method 1603 (membrane filtration with modified mTEC)
– samples chilled
– delivered to lab within 6 hours of sample being taken.
2) mTEC agar (EPA 2010, APHA 2012, ASTM 2000)
3) mColiBlue PourRite Ampules (Hach method 10029)
4) mEndo followed by NA-MUG agar (APHA 1997)
5) MI agar (EPA 2012)

Most Probable Number (units: MPN/100mL)
1) Colilert (Quantitray 2000 tray)
2) Colilert 18 (Quantitray 2000 tray)

Approved methods for harvest/postharvest agricultural water* (40 CRF 136.3)
Detection (Presence/Absence of generic E.coli) for 112.44(a)(1) to (4)

Broth-based methods of detection in 100mL water
1) Veolia TECTA EC/TC medium and TECTA Instrument
2) CPI Modified Colitag Test method
3) IDEXX Colilert, Colilert 18 and Colisure
4) Charm Sciences E*Colite Bag or Vial Test
5) Millipore Readycult Coliforms 100
*No detection of E.coli would allow use of this water for production agricultural water.

112.46(a)(1) and (2) -Public Water Source (Treated water)
– Copy of test results of no detectable generic E.coli/100mL water  or current certificates of compliance with the Safe Drinking Water Act
– no need to independently test water

122.50(b)(6) – document all actions taken during testing, inspection, reinspection, and corrective actions (including water treatment monitoring* if applicable) when E.coli exceeds limit and how returned to compliance.
* not required to determine generic E.coli levels after treatment

Corrective action (time 0.5 log / day reduction action)
– specific time interval or log reduction applied (if not the 0.5)
– how the time interval or log reduction was determined
– dates of corresponding activities such as date of last irrigation and harvest
– date of harvest and end of storage
– dates of activities such as commercial washing (if applicable).

Must retain on file proof of concept for microbial die off/commercial washing efficiency, adequacy of testing methodology, and reasoning and scientific establishment data for “other” methodology.

Agricultural Water Part 2: Postharvest (Harvest and postharvest) Water

-112.43 Water quality testing (detection)
112.42(a) Findings of annual or more frequent inspections of water system
112.46 (b) Microbial Water Quality Plan
– Untreated Ground water Testing Requirements
112.46(b)(1_(i)(B) initially – 4 or more times during the growing season or over the period of a year
112.46(b)(2)(i)(B) annually – 1 or more samples
If test values exceed no detectable generic E.coli, restart with 4 samples/year.
112.46(b) – each water source must be tested to establish the initial profile and the annual samples to update the prole for each sample.*
   – using ground water as agricultural water, then storing ground water in a pond and then using the pong water as agricultural water turns that stored water into surface water and requires a whole new MWQP.
112.46(b)(3) ~MWQP must be restarted if water quality profile no longer represents the quality of the water source

Approved methods for harvest/postharvest agricultural water* (40 CRF 136.3)
Detection (Presence/Absence of generic E.coli) for 112.44(a)(1) to (4)

Broth-based methods of detection in 100mL water
1) Veolia TECTA EC/TC medium and TECTA Instrument
2) CPI Modified Colitag Test method
3) IDEXX Colilert, Colilert 18 and Colisure
4) Charm Sciences E*Colite Bag or Vial Test
5) Millipore Readycult Coliforms 100

Goal: No detection of generic E. coli/ 100mL water

112.46(a)(1) and (2) -Public Water Source (Treated water)
– Copy of test results of no detectable generic E.coli/100mL water  or current certificates of compliance with the Safe Drinking Water Act
– no need to independently test water
122.50(b)(6) – document all actions taken during testing, inspection, reinspection, and corrective actions (112.43(b)) including water treatment monitoring* if applicable) when E.coli exceeds limit and how returned to compliance.
* not required to determine generic E.coli levels after treatment
* water treatment monitoring depends upon the sanitizer or pesticide in question. Ex. Chlorine based sanitizers require a certain pH range to function properly.
*Monitor pH (112.43(b)), temperature (112.48©), visually monitor for buildup of organic material (turbidity) (112.48(b)) have a change water schedule (112.48(a))
*Must retain on file proof of concept for microbial die off/commercial washing efficiency, adequacy of testing methodology, and reasoning and scientific establishment data for “other” methodology.

Any pesticide (including sanitizers) must be labeled for use on fresh fruits and vegetables.

Postharvest Handling and Sanitation

Cleaning and sanitization of all tools, equipment and containers used in covered activities
– date
– method of cleaning and sanitizing

Clean break – after cleaning AND sanitization of food contact surface
– include date, time, personnel (who did the act), how (SOP followed, product used, etc), what (food contact surface), monitoring steps.
– helps to establish distinct lots to avoid massive recalls.

112.128 – routine monitoring for pests and all other pest management practices
– 3rd party pest control company should fill out a log sheet

Cooler temperatures are monitored and recorded at beginning of each day.

Vehicle inspection for transporting covered produce before loading
– clean, free of physical debris, no odors, (if possible, refrigeration works and at set temperature)

Corrective action if food safety risks are identified in the packing, washing, storage or transportation of produce
– includes both short term and long term solutions

Labeling: FSMA modified Requirements for Farms that may be Exempt

Commercial Processing Exemption

Produce is eligible for exemption under these conditions:

1) The produce receives commercial processing (including refining and distilling) that adequately reduces the presence of microorganisms of public health significance (e.g., processing of tomato paste or shelf stable tomatoes, processing produce into products such as sugar, oil, spirits, wines, and beer)

2) You must disclose in documents accompanying the produce, that the food is “not processed to adequately reduce the presence of microorganisms of public health significance”; and

3) You must either:

  1. i) Annually obtain written assurance, subject to the requirements of 112.2(b)(6), from the customer that performs the commercial processing described in 112.2(b)(1) that the customer has established and is following procedures that adequately reduce the presence of microorganisms of public health significance; or
  2. ii) Annually obtain written assurance, subject to the requirements of 112.2(b)(6), from your customer that an entity in the distribution chain subsequent to the customer will perform commercial processing described in 112.2(b)(1) and that the customer:
  3. A) Will disclose in documents accompanying the food that the food is “not processed to adequately reduce the presence of microorganisms of public health significance”; and
  4. B) Will only sell to another entity that agrees, in writing, it will either:

                                             1) Follow procedures that adequately reduce the presence of microorganisms of public health significance; or

                                             2) Obtain similar written assurance from its customer that the produce will receive commercial processing described in 112.2(b) (1) and that there will be disclosure in documents accompanying the food, that the food is “not processed to adequately reduce the presence of microorganisms of public health significance”; and

4) You must establish and maintain documentation of your compliance with requirements in 112.2(b)(2) and (3) in accordance with the requirements of subpart O (Records), including:

  1. i) Documents containing disclosures required under 112.2(b)(2); and
  2. ii) Annual written assurances obtained from customers required under 112.2(b)(3); and

5) The requirements of subpart A (General Provisions) and subpart Q (Compliance and Enforcement) apply to such produce; and

6) An entity provides a written assurance under 112.2(b)(3)(i) or (ii) must act consistently with the assurance and document its actions taken to satisfy the written assurance

Qualified for exemption in 112.5 – Qualified Exempt

3 year average food sales less than $500K AND 3 year average sales of food to qualified end users (direct consumers or restaurants, grocery stores, convenience stores, vending machines) exceeds (greater than) average monetary values of food sold to all other buyers.

112.6(b) – if qualified exempt:
1)  When food packaging label is required on food that would otherwise be covered produce under the Federal Food, Drug, and Cosmetic Act, you must include prominently and conspicuously on the food packaging label the name and complete business address of the farm where the produce is grown.

2 When a food packaging label is not required on food that would other wise be covered produce under the Federal Food, Drug and Cosmetic Act, you must prominently and conspicuously display, at the point of purchase, the name and complete business address of the farm where the produce was grown, on a label, poster, sign, placard, or documents delivered contemporaneously with the produce in the normal course of business or, in the case of internet sales, in an electronic notice.

3) The complete business address must include the street address or PO box, city, state, and zip code for domestic farms, and a comparable full address for foreign farms.