PSR.17 Does the definition of “biological soil amendment of animal origin” in the Produce Safety Rule include seafood-derived material? In other words, are fish considered animals for the purposes of this rule? Does this include shellfish? Does it include shellfish shells after the actual organism is removed?

The definition of BSAAO, in 21 CFR 112.3, means any soil amendment which consists, in whole or in part, of materials of animal origin, such as manure or non-fecal animal byproducts. Non-fecal animal byproduct, which is also defined in 21 CFR 112.3, means solid waste (other than manure) that is animal in origin and is generated by commercial, institutional, or agricultural operations. Examples of non-fecal animal byproduct include fish meal, shellfish waste, and fish emulsions.

HUMAN WASTE

PSR.18 Would the provisions of the Produce Safety Rule impact the use of biosolids for the growing of vegetable crops or other covered produce?

You may not use human waste for growing covered produce, except that sewage sludge biosolids may be used in accordance with EPA regulations in 40 CFR part 503, subpart D (Pathogens and Vector Attraction Reduction), or equivalent regulatory requirements (see 21 CFR 112.53).  “Sewage sludge biosolids” are defined in 21 CFR 112.3  as the solid or semi-solid residue generated during the treatment of domestic sewage in a treatment works within the meaning of the definition of “sewage sludge” in 40 CFR 503.9(w).

TREATMENT PROCESSED

PSR.19 What are some examples of “scientifically valid methods” that may be used to treat raw manure, during the production of stabilized-and-cured compost, so that it can be used in the production of fresh produce as a treated BSAAO?

We would first like to point to a few definitions in the Produce Safety Rule to help clarify our response.

21 CFR 112.3 defines “composting” as a process to produce stabilized compost in which organic material is decomposed by the actions of microorganisms under thermophilic conditions for a designated period of time (for example, 3 days) at a designated temperature (for example, 131°F (55°C)), followed by a curing stage under cooler conditions.

“Curing” is further defined as the final stage of composting, which is conducted after much of the readily metabolized biological material has been decomposed, at cooler temperatures than those in the thermophilic phase of composting, to further reduce pathogens, promote further decomposition of cellulose and lignin, and stabilize composition.  Curing may or may not involve insulation, depending on environmental conditions.

21 CFR §112.54(b) provides two examples of scientifically valid controlled biological processes (e.g., composting) that meet the relevant microbial standard. The first is static composting that maintains oxygenated conditions at a minimum of 131°F (55°C) for 3 consecutive days and is followed by adequate curing. The second is turned composting that maintains oxygenated conditions at a minimum of 131°F (55°C) for 15 days (which do not have to be consecutive), with a minimum of five turnings, and is followed by adequate curing. In either case, the resulting biological soil amendment must be applied in accordance with the applicable requirements of 21 CFR 112.56. Additionally, for a treated BSAAO you produce for your own covered farm, you must establish and maintain documentation that process controls (for example, time, temperature, and turnings) were achieved per 21 CFR 112.60(b)(2).

Note that there may be additional processes in addition to those described in 21 CFR §112.54(b) that satisfy the requirements in 21 CFR §112.54 for treated BSAAOs

MICROBIAL STANDARDS FOR THE TREATMENT PROCESSES

PSR.20 What are the set microbial limits for Listeria monocytogenes, Salmonella spp., fecal coliforms, and E. coli 0157:H7, and do these limits apply to both stabilized compost and raw manure?

We have provided the microbial standards against which treatment processes must be validated (see 80 FR 74353 at 74472 (Comment/Response 288)), and the rule allows for use of controlled physical, chemical, or biological treatment processes, or combinations thereof (including composting) that achieve those microbial standards. The rule does not require microbiological testing of treated BSAAO to ensure that they meet the relevant microbial standards.

For a BSAAO to be considered “treated” for the purposes of 21 CFR 112.51, the BSAAO must be treated via a process described in 21 CFR 112.54 that meets the applicable microbial standards in 21 CFR 112.55.

The following microbial standards apply to the treatment processes in 21 CFR 112.54:

(a) For L. monocytogenes, Salmonella species, and E. coli O157:H7:

Or, (b) Salmonella species are not detected using a method that can detect three MPN Salmonella species per 4 grams (or milliliter, if liquid is being sampled) of total solids; and less than 1,000 MPN fecal coliforms per gram (or milliliter, if liquid is being sampled) of total solids.

Raw manure must be regarded as “untreated” under 21 CFR112.51. See 80 FR 74353 at 74472 (Comment/Response 277). Stabilized compost may be considered “treated” provided that the compost treatment process has been validated to meet the applicable requirements, including satisfying one of the microbial standards in 21 CFR 112.55. Examples of composting that satisfy treatment process requirements in 21 CFR 112.54(b) and satisfy the microbial standard in 21 CFR 112.55(b) are found in 21 CFR 112.54(b)(1) and 21 CFR 112.54(b)(2).

APPLICATION REQUIREMENTS AND MINIMUM APPLICATION INTERVALS

PSR.21 How does the FDA plan to determine how much time should be required between the application of raw manure and the harvest of produce covered by the rule?

The final produce rule contains requirements related to the safe use of biological soil amendments of animal origin, including raw manure, in Subpart F. With regard to the application of untreated biological soil amendments of animal origin, including manure, applied in a manner that does not contact covered produce during application and minimizes the potential for contact with covered produce after application, the FDA is deferring action on an application interval until we pursue certain steps, including a risk assessment and research to supplement the science on an appropriate interval. We anticipate that these efforts will take five to 10 years to complete. Following the completion of the risk assessment and research work, we expect to: (1) provide stakeholders with data and information gathered from scientific investigations and risk assessment; (2) consider such new data and information to develop tentative scientific conclusions and regulatory decisions; (3) provide an opportunity for public comment on our tentative decisions; and (4) consider public input to finalize the provision(s) establishing an appropriate minimum application interval(s). See 80 FR 74353 at 74462-63 (Comment/Response 257).

RECORDS REQUIREMENTS FOR BSAAO

PSR.22 Should bagged grass clippings from lawn care companies be considered BSAAOs due to the possibility of inclusion of domesticated animal feces?

First, we note that the definitions of “yard trimmings” and “pre-consumer vegetative waste” in 21 CFR 112.3 stipulates that these are purely vegetative materials. To the extent that vegetative waste is known to include animal feces, it would not meet the definitions of “yard trimmings” or “pre-consumer vegetative waste,” and a soil amendment made from such material would instead be a biological soil amendment of animal origin included in the scope of the provisions of subpart F. However, we recognize that even in purely vegetative material such as that described in the definition of “yard trimmings” or “pre-consumer vegetative waste,” there is the potential for unknown and unavoidable contamination with animal waste. We have concluded that the likelihood of contaminating produce with pathogens by use of biological soil amendments that are not known to contain, and not likely to contain significant animal waste or human waste (e.g., yard trimmings, pre-consumer vegetative waste) is low, and therefore they are not subject to the requirements of this rule. See 80 FR 74353 at 74464 (Comment/Response 263).