AMERICAN MUSHROOM INSTITUTE

Transcription

1 AMERICAN MUSHROOM INSTITUTE One Massachusetts Avenue NW, Suite 800, Washington, DC Phone (202) Fax (202) November 15, 2013 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD RE: Docket No. FDA-2011-N-0921 RIN 0910-AG35 Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption. These comments on the proposed rule are submitted on behalf of the American Mushroom Institute, the national trade association that represents domestic mushroom farms, packinghouses, shippers and processors, as well as entities that provide goods and services for the mushroom industry. According to the U.S. Department of Agriculture, there are 298 mushroom growing operations in the United States, producing million pounds of mushrooms last year with a farm gate value of $1.11 billion. (USDA/NASS Mushrooms - August 20, 2013). In General: Our overall assessment is that the proposed rule adequately covers the science-based minimum standards for safe growing, harvesting, packing and holding of mushrooms. It closely mirrors the Mushroom Good Agricultural Practices (MGAP) program a commodity-specific food safety plan developed by the mushroom industry, academics and food safety experts which provides a set of standards, procedures and guidelines that mushroom growers can use to enhance and document safe mushroom growing, harvesting and shipping practices. Indeed, the fact that the MGAP standards so thoroughly accomplish the goals of the proposed rule in the case of mushroom production, while differing in certain respects from specific details of the proposed rule, is the reason for our most significant recommendation. We urge a modification allowing FDA to receive requests for variances for specific commodities and sanction national, commodity-specific programs, therefore making it easier to tailor the rule to 1

2 conform to the risk factors and practices of specific commodities while ensuring full compliance with the goals of the rule. The proposed rule already allows a state or a foreign government to request a variance from some or all provisions of the proposed rule if the practices under the proposed variance provide the same level of public health protection as the requirements of the proposed rule without increasing the risk of adulteration. The proposed rule provides a process by which FDA would consider such requests and approve or deny them. AMI proposes that Subpart P be expanded to allow for variances for specific commodity standards, following the standards outlined in the proposed rule, but based on the risk profile of the commodity. The variance could be requested by commodity organizations or other parties which would provide science-based justification. This would allow FDA to take advantage of the tremendous efforts undertaken in developing and implementing food safety programs on a commodity-specific, industry-wide basis. These commodity-specific standards more closely reflect the unique growing, harvesting and packing processes for the particular commodity than any general rule could. As noted above, the mushroom industry has developed an industry-wide program of good agricultural practices for mushroom production, harvesting and packing based on previous FDA guidance. With minor changes, the MGAP standard would meet all of the applicable requirements of the proposed rule. We believe allowing commodity-specific programs which address the unique risk profile of that commodity to be eligible to apply for a variance would result in stronger food safety practices. Comments on Specific Sections and Issues: Our comments in SECTION I. refer to the relevant subpart of the proposed regulations, and our comments in SECTION II. refer to specific issues requested by FDA. SECTION I. Subpart A General Provisions 112.1(b)(1) Definitions. We agree that mushrooms should be included as covered produce Definitions. We agree with the definitions listed below; all of which are applicable to the materials, processes, and procedures used in mushroom production: o Biological soil amendment o Biological soil amendment of animal origin o Composting o Growth media o Humus o Manure o Soil amendment 2

3 o Static composting o Turned composting Subpart C Standards Directed to Personnel Qualifications and Training (a) All personnel must receive adequate training upon hiring, at the beginning of the growing season (if applicable) and periodically thereafter. Mushrooms are grown year-round; therefore the beginning of the growing season is not applicable. MGAPs call for training at hiring, more extensive training afterwards, and annual refresher training (c) Minimum requirements for training personnel; standardized curriculum recognized as adequate by FDA. While we agree there should be minimum standards, there should be flexibility which recognizes the unique production techniques and growing conditions and varying areas of risk for different commodities. Granting commodity-specific variances would provide targeted training based on the identified risk factors inherent to that commodity. Subpart E Standards Directed to Agricultural Water (a) At the beginning of the growing season, you must inspect the entire agricultural water system under your control. Mushroom production is conducted year-round, so there is no set growing season, therefore we suggest the addition of as applicable or at least annually. We are also concerned with the phrase the entire agricultural water system under your control (including water source, water distribution system, facilities and equipment) used here, and in (d)(1) and in (b) and (c) regarding re-inspection. Mushroom production takes place in enclosed buildings that may be separated by a few feet or a few miles. Many are serviced by more than one water system. Inspections should be conducted at each water source and re-inspections under (d)(1), (b) and (c) should be limited to locations serviced by the source where the problem was identified. We suggest the following change with regard to inspection: the water system under your control that is serviced by that source (a) You must test agricultural water.at the beginning of each growing season, and every three months thereafter during the growing season. 3

4 Mushroom production is a continuous, year-round activity without defined growing seasons. Municipal or well water is used throughout the production cycle. Surface water is not used as agricultural water in mushroom production. The MGAP standard calls for water testing twice yearly, we believe this to be adequate. Subpart F Standards Directed to Biological Soil Amendments of Animal Origin and Human Waste The growing medium, known as mushroom substrate, used in mushroom production would be defined as a soil amendment under the proposed rule. It is a mixture of agricultural materials, such as straw from horse stables, hay, poultry litter, ground corn cobs, cottonseed hulls, cocoa shells, peat moss, and other natural organic substances. These products are formed into a rich organic medium that serves as the primary nutrient source for mushrooms. Animal wastes are typically a component of mushroom substrate; therefore, it would be classified as a biological soil amendment of animal origin under the proposed rule. As FDA notes, the production of mushroom growth medium goes through a two-phase process consisting of a composting treatment that meets the composting standard proposed in (c) followed by a subsequent heating process that meets the microbial standard of proposed (a). Given that this unique growing medium provides the primary source of nutrients for the mushroom to grow, extensive research has been conducted on its properties, including a recently published study (Weil et al. 2013) 1, that demonstrates that the treatment reduces Listeria, Salmonella and E. coli to undetectable levels. AMI strongly agrees with FDA s tentative conclusion that a treatment process meeting this standard would significantly reduce or eliminate known or reasonably foreseeable microbial hazards in biological soil amendments of animal origin and would constitute the lowest expected likelihood of any of the proposed treatment options. We also strongly agree with FDA s statement that any biological soil amendment of animal origin treated to this standard would have the fewest limitations on its application. Therefore, we agree with proposed regarding what requirements apply for determining the status of a biological soil amendment of animal origin and proposed regarding the handling, conveying and storing of biological soil amendments of animal origin. These standards are consistent with the MGAP standards. As noted above, we agree with the treatment processes outlined in and regarding the microbial standards that apply to the treatment processes. These are consistent with MGAP standards. 1 Weil J, Beelman RB, Cutter CN, LaBorde LF Inactivation of human pathogens during Phase II composting of manure-based mushroom growth substrate. Journal of Food Protection. 76(8):

5 We agree with (a)(2) application requirements and minimum application intervals. Since the treatment process outlined in (a) is applicable to mushroom composting, there would be no time interval restriction for its use. This is consistent with the MGAP standard. Spent Mushroom Mulch: FDA specifically requests comments on how to classify the status of spent mushroom mulch (growing media already used in the production of mushrooms for subsequent use as a biological soil amendment of animal origin in the growing of other covered produce). First, we strongly argue that spent mushroom mulch should not be defined as a biological soil amendment of animal origin. It should be accurately classified as a soil amendment. Secondly, no further treatment should be required. And lastly, there should be no minimum application interval. We agree with FDA s conclusion that if the spent mushroom mulch has been subject to the treatment process which met the microbial standard, it would still be considered treated and therefore available for use in any covered commodity without any intervening treatment. FDA provides reference that the practice of storing spent mushroom mulch for subsequent use in the growing of covered produce is not known to be a likely source of introduced contamination because the growth media would have been previously treated to eliminate pathogens. Additionally, at the end of the mushroom production cycle, the growing medium is steam treated. This process serves several purposes to kill pests, weed seeds and mushroom disease pathogens in the growing room and in the growing medium. After this stage, there are no biological or microbial contaminants of food safety concern in the spent mushroom mulch, as it has been through three processes as outlined in (c), (a), and the post-crop steam process. FDA s reasoning is inconsistent in that it concludes that spent mushroom mulch would be considered treated to the meet the standards of (c) for subsequent use without any intervening treatment but then also concludes spent mushroom mulch would be subject to restrictions on its application to covered commodities. For application requirements, spent mushroom mulch is classified as if it has ONLY been treated by composting ( (c)) even though it has also gone through another rigorous scientifically valid controlled physical process ( (a)). As a result of the treatment processes that it has received, spent mushroom mulch should not be deemed to be of animal origin when used as a soil amendment for other agricultural applications. The threat of pathogens originating from the ingredients initially used to produce the growing media has been eliminated by a scientifically valid 5

6 controlled physical process and even more so by steaming the spent mushroom mulch after harvesting is completed. Essentially the link between animal manure and the growing media has been severed by these treatment processes, and the spent mushroom mulch should be considered equivalent to a soil amendment that does not contain animal manures and that does not have any application interval requirement. Therefore, there is no scientifically justified reason to subject spent mushroom mulch used subsequently to grow other covered produce to the requirement to minimize the potential for contact with covered produce during and after application and the minimum application interval of 45 days. The statement that the weathering process for spent mushroom mulch is similar to composting in terms of introduction of contaminants is unclear as to which contaminants of concern it is referring (b)(2) Required records. In geographic areas where mushroom production is concentrated, it is common for smaller scale growers to purchase growing media/substrate (classified as treated biological soil amendments of animal origin). We concur that growers should obtain documentation as outlined in proposed (b)(2) from their supplier. Since the treatment process has been scientifically documented and validated, annual verification is sufficient (b)(3) Required records. It is a MGAP standard for mushroom farms producing their own growing media to document that process controls were achieved as outlined in (b)(3), therefore we agree with this section. Subpart I Standards Directed to Domesticated and Wild Animals We agree with (b) that the requirements of this subpart should not apply when a covered activity takes place in a fully-enclosed building. Mushroom growing houses are fully-enclosed buildings. Subpart K Standards Directed to Growing, Harvesting, Packing and Holding Activities You must package covered produce in a manner that prevents the formation of Clostridium botulinum toxin if such toxin is a known or reasonably foreseeable hazard (such as for mushrooms). While we agree that all produce should be packaged in a manner that prevents the formation any pathogen, we strongly urge that the words (such as for mushrooms) be removed since there is no scientific reason to single out one commodity. 6

7 Significant changes in packaging have occurred since the cited research was conducted in But even then, the researchers concluded, The botulism hazard in fresh mushrooms wrapped in commercial polyvinylchloride (PVC) film appears to be minimal. At the end of their normal shelf-life, 1,078 packages of PVC-wrapped mushrooms were all free of botulinum toxin. To our knowledge, there have been no reported cases of botulism found in fresh mushrooms. In addition, FDA notes, Mushrooms grow close to the ground, which is a source of C. botulinum spores. There are dozens of covered commodities that grow close to the ground and C. botulinum is present in water and soil, so potentially any food that comes into contact with such vectors is a potential hazard. Singling out mushrooms is unwarranted. Lastly, packaging of mushrooms using food grade plastic overwrap for retail customers is in all likelihood done in a packinghouse, by automated machinery, and would be subject to current regulations governing good manufacturing practices and the proposed preventative controls rules, not the produce safety rules. Subpart L Standards Directed to Equipment, Tools, Buildings, and Sanitation (a)(3) Building construction drip or condensate does not contaminate produce, food contact surfaces or packing material. By nature of the indoor growing process, there is sometimes condensate in a mushroom growing room. However, since growing rooms are cleaned and sanitized between each crop, the condensation does not come from an unsanitary surface, so this poses no threat of contamination and Requirements applicable to toilet facilities and for hand-washing facilities. We recommend that the proposed rules either simply reference OSHA field sanitation standards (29 CFR ) or mirror it as closely as possible to avoid confusion and conflicting requirements. The example of clean cloth towels listed as adequate drying devices in the proposed rules conflicts with OSHA s requirement of single-use towels. Subpart O Requirements Applying to Records that You Must Establish and Keep With the number of records that are being required, we believe the final rules should allow for the simplest method while still accomplishing the goal of documentation, including those for corrective actions. There should be allowances made for situations when the person who is responsible for the initial record is the owner or supervisor, in which case he or she should also be allowed to document the review of the records. While documentation is vital, the paperwork burden imposed by the regulations should 7

8 not be so overwhelming that the actual tasks being recorded by the paperwork take a secondary role. Subpart P Variances Who may request a variance from the requirements of this part? As noted at the beginning of our comments, AMI strongly believes that Subpart P Variances should be broadened to include petitions on behalf of specific commodities. The petitions could be filed by commodity organizations, boards or commissions on behalf of their growers. The same process and procedure could be followed as outlined in the proposed rule. Conceivably, a complete standard, mirroring the standard where applicable, but including specific practices or processes unique to that commodity, would provide a stronger standard, one that growers could more easily understand and would insure more consistent implementation and enforcement. Subpart Q Compliance and Enforcement We agree with other commenters who have noted that once the rules and requirements under FSMA are finalized, it will fall to FDA to ensure compliance by the produce industry. As the agency is unlikely to have the resources required to take on the compliance function, we believe it makes sense for the agency to partner with existing state and industry programs that are committed to protecting food safety through the adoption of food safety practices that are equivalent to or more rigorous that those included in the new FSMA rules. SECTION II. Regulatory approach We generally agree with the integrated approach to prescribe standards for the various routes of contamination. This is the same approach taken with the development of the Standards for Mushroom Good Agricultural Practices (MGAP). We agree with FDA s tentative conclusion that controls should be tailored, taking into account the analysis done by the farm in certain areas, to the potential routes of contamination that each commodity presents based on the agricultural practices employed and the characteristics of the commodity and the environmental conditions under which it is grown. This is a concise rationale for the use of commodity-specific variances. 8

9 Chemical, physical or radiological hazards We support the tentative decision made by FDA not to set specific standards for chemical, physical or radiological hazards related to produce. The focus of the proposed rule is appropriately targeted on microbiological hazards. Growers are already regulated at both the state and federal levels on the use of agricultural chemicals, and this should not be duplicated. Physical and radiological hazards should be excluded from the rule since growers have little to no control or influence over radiological hazards, and physical hazards rarely if ever reach the threshold of causing severe adverse health consequences or death. Environmental testing for L. monocytogenes or Listeria spp for covered produce other than sprouts We oppose mandated environmental testing. The Food Safety Modernization Act enables FDA to focus more on preventing food safety problems rather than primarily reacting to problems after they occur. As stated in the agency s own words. Because L. monocytogenes is a ubiquitous microorganism, an intact fruit or vegetable could reasonably be expected to occasionally be positive for L. monocytogenes. Environmental testing should be a choice made by the grower based on their own risk assessment. Testing is not a guarantee of product safety. When not properly designed and performed, testing can provide inaccurate information that can easily be taken out of context and create unwarranted concerns or false reassurances about the safety of the product. Registration We oppose mandated registration of facilities. The agency notes that one benefit of a database would be outreach and technical assistance. There are organizations that are better suited to provide this outreach on a targeted basis, such as land grant universities, cooperative extension, commodity organizations, and state departments of agriculture. Environmental issues Water: Mushroom production requires a significant amount of water that is applied directly to the growing media and to the mushrooms themselves. Only well water and water from municipal sources are used; surface water is not used as agricultural water as defined by the proposed rule. The use of water is a good example of where commodity-specific variances would address the unique production characteristics of various commodities. Biological soil amendments of animal origin: As noted, biological soil amendments of animal origin are part of the growing media used in mushroom production. Scientific studies are referenced that note the processes which render the material safe. Individual farms with the assistance of state and county conservation districts have developed plans for best practices for environmental management with strategies for mitigation of air and water impacts. 9

10 Request for a second public comment period AMI recognizes the effort and commitment FDA has made by extending the comment period twice to ensure impacted individuals and organizations have time to provide feedback on the proposed rule. As a result, we believe that the final rule will be significantly different than the current proposed rule. Because of this, the rule should be re-released for a second public comment period before it is finalized. AMI proposes that FDA analyze the comments it receives during the comment period and re-write the produce safety rule based on comments received and communications held with stakeholders since the proposed rule was first published. The revised rule should be posted for a second comment period prior to promulgation of a final rule. The American Mushroom Institute appreciates the opportunity to comment on the proposed rule. We welcome your questions and look forward to continuing to work with FDA on food safety issues. 10