The third FDA Proposed Produce Food Safety Rule Q & A conference call, coordinated by the Produce Safety Alliance, was held on Monday. This conference call focused on soil amendment use in the proposed rule. Details on soil amendments in the proposed rule can be found in Section F Biological Soil Amendments. The FDA officially announced that it will extend the comment period by 120 days, allowing comments until September 16, 2013. Visit the FDA webiste to comment on these proposed rules.
Here are the questions from agricultural organizations and growers and answers from the FDA on Monday’s conference call:
1. If raw manure is applied to a field and then plastic is laid prior to seeding or transplanting is this a practice that is accepted to reduce the days to harvest to zero?
The only situation where raw manure can be applied to a production area and a zero days to harvest would be applicable would be if there was no possible way for that raw manure to touch the harvestable product. Growers must consider the ability of the manure to splash onto the crop during rains or watering as well as the ability of dust to travel onto the crop.
2. Was there an attempt to create formulas based on different types of manures (horse, sheep etc.)?
The FDA recognizes that there are different levels of risk associated with varying types of manures and production methods. The FDA decided to use the most restrictive measures. The FDA does encourage growers to utilize the ability to create alternatives to the rule when there is scientific evidence that an alternative practices would be an acceptable alternative.
3. Is domestic animal waste considered to be of animal origin as covered in the rule?
Yes, it is considered animal manure.
4. How are composts that are made from vermiculture and/or cured or cold composted for several years affected by the rule?
These types of composts will need validation of die-off of human pathogens in order to prove that they meet the standards of the proposed rule.
5. What is required of purchased composts to verify that they meet the standards of the proposed rule?
A certificate of conformance from the producer is needed.
6. If you are producing your own compost and using it yourself, is testing required?
No, testing is not required when you are producing compost for your own use. USDA NRCS and the EPA-California have documents that outline compost production methods that would meet the standards of the proposed rule. Growers are encouraged to adopt these methods of composting so that there is a multiple hurdle approach to reducing pathogens.
7. If windrows are only turned two times how would that compost be classified?
It would not have completed the needed turning and would be considered raw manure and therefore need to comply with the raw manure standards.
8. Are blood meal, bone meal etc. considered to have already completed a kill step?
These amendments are considered biological and of animal origin. Validated procedure info is needed in order to qualify for the zero days to harvest. A certificate of conformance is needed, but this information may also be found on the product label. (This type of documentation is acceptable.)
9. How does the National Organic Program and FSMA differ on composting regulations?
The FDA looked at the NOP regulations when creating FSMA. FDA also reviewed literature that was published after the NOP standards were put into place. The FDA recognizes that composting reduces a significant, but not complete, amount of pathogens. The FDA decided to add 45 days to the timing. This additional time should not affect a significant number of farms.
10. NOP states that manure should be tilled into the soil 3-4 months prior to harvest, why does FSMA not state this as well?
If the FDA had information on a validated study showing that tillage adequately reduced pathogens in the soil they would consider it. The FDA does seek comments regarding tillage and raw manure use.
11. Why is there such a difference in the NOP standard of 120 days and FSMA standard of 9 months from application to harvest?
The FDA found little scientific basis for the 120 day wait time. The FSMA rule needs to be universally applicable. Again, we expect that some groups will need to rely on the scientifically based alternative methods to the rule.
12. If there is enough science and comment to validate the 120 days from raw manure application to harvest time frame with the FDA be willing to change the rule as it stands now?
Yes, provided there is enough scientific information to validate the 120 day wait time.
13. What exactly qualifies as an alternative method?
An alternative method is expected to be used by a community/group of growers whose production practices are similar. The foundation of this alternative method is scientifically validated research data on specific production practices.
14. There does not seem to be a lot of funding out there to research alternative methods and to document practices. Will funding become available?
The FDA encourages researchers and groups to utilize USDA NIFA and Block Grant funds. Large groups should pool their resources to fund production practice research.
15. The 9 month waiting period is a hardship, did the FDA take into consideration the short growing season experienced in some regions?
Yes, this is a good reason to put regional alternative methods into place. Growers are encouraged to use compost rather than raw manure.
16. Extension labs are experiencing a high number of requests for microbiological testing resources, but there is little funding to support equipment and supplies. Will there be funding for labs?
There is funding for FSMA technical assistance in NIFA alternatives grants. The contact for food safety at NIFA is Jodi Williams.
17. The animal feeds rule is expected to impact raw manure use on farms. When can we expect to see that rule released?
We do not know, but is should be soon. There will be interplay between the two rules and this is in part why the comment period has been extended 120 days.
18. Is FSMA set up to incorporate new research as it becomes available?
Yes, the alternative methods provision allows for this.
