The Food Safety Modernization Act
Comments about these revised rules are due to the FDA by December 15, 2014. If you haven't already done so, I encourage you to review the key revisions summarized on the FDA FSMA website (http://www.fda.gov/food/guidanceregulation/fsma/default.htm), as well as my comments below regarding some of the key revisions. You might also want to look at the National Sustainable Agriculture Coalition's excellent review of the FSMA: http://sustainableagriculture.net/fsma/; I reviewed their materials and borrowed some their language for this article.
You can submit your comments to the FDA at: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0921-0973 (for the Produce Rule) and http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-1553 (for the Preventive Controls Rule).
Revised Definition of Covered Farms
However, the FSMA's $500,000 sales threshold (adjusted for inflation) for a farm to be eligible for modified requirements through a qualified exemption still relates to total farm revenues, rather than just produce sales. This cannot be changed because the text of the FSMA legislation specifically refers to “all food sales” A farm is eligible for modified requirements if it:
- has less than $500,000 in annual gross sales (adjusted for inflation) of all food products (includes commodities, hay, dairy, livestock as well as produce) over a previous three-year period AND
- sells the majority of the food directly to “qualified end-users”--consumers, restaurant and retail food establishment (e.g., a grocery store) that is located in the same state as the farm or not more than 275 miles from the farm.
Complying with the modified requirements means that a farm only needs to:
- Provide the name and complete address of the farm where the produce was grown on either a food packaging label or on a sign at the point of purchase;
- Comply with the “compliance and enforcement requirements” of the Produce Rule; and
- Be subject to the provisions regarding the withdrawal of your status as a partially covered (“qualified exempt”) operation; FDA can revoke your “qualified exempt” status in certain circumstances.
Broadened Definition of a “Farm”
Under the revised FSMA provisions, a farm that packs or holds raw agricultural products grown on another farm under a different ownership no longer has to register as a “food facility”. The original rule would have required a farm that aggregates produce from multiple farms for a CSA program to meet the Preventive Controls requirements. The revised rules will allow the farm to comply only with the Produce Rule. The “farm” may also:
- Pack or hold raw agricultural products;
- Manufacture or process food for on-farm consumption only;
- Dry/dehydrate raw agricultural products, as long as there is no additional processing; and/or label and package raw agricultural products as long as there is no additional processing.
Please be aware that the FSMA's terminology is very nuanced. Chopping or slicing fresh produce for sale – like carrots or apples – is considered to be processing, which means that you operate a “facility.” (Certain harvesting activities like trimming outer leaves of produce, or removing stems or husks, are not considered processing.). Washing is considered part of harvesting when done in the field. But, if it is done during the production of fresh-cut produce, for example, it is considered manufacturing or processing. Labeling and packaging are considered manufacturing activities unless you are labeling or packaging a raw agricultural product and are not doing any additional manufacturing or processing to the product. If there is no additional manufacturing or processing, labeling and packaging are considered farm activities and do not trigger the facility definition.
Revised Water Quality Standard and Testing Are More Flexible
For farms that have to test their water, the FDA is proposing three numerical standards below for testing.
- No detectible E. coli present per 100 ml of water: This standard would apply to water used for an activity during and after harvest, water used to make agricultural teas, and water used in sprout irrigation. The quality of untreated surface water used for these purposes must be tested from each source of the water “with an adequate frequency to provide reasonable assurances that the water meets the required standard”. You must have adequate scientific data or information to support your testing frequency.
- Farms using untreated groundwater for purposes that trigger a testing requirement will now have to test their water supply a maximum of 5 times in the first year (4 per year/growing season plus one test per year) rather than testing on a quarterly basis as originally proposed. Their untreated groundwater used to irrigate in a manner that directly contacts the harvestable portion of the crop will have to meet the following standard: a geometric mean of no more than 126 colony forming units (CFUs) per 100 ml.
- Testing of untreated surface water used for growing produce other than sprouts involving direct contact with the harvestable portion will require the collection of 20 samples over the first 2 years, followed by an annual minimum sampling of 5 per year, rather than monthly or weekly as previously required. The water will have to meet the following standard: a statistical threshold value (STV) of 410 CFUs generic E. coli per 100 ml for a single water sample, and a geometric mean of no more than 126 CFU per 100 ml. If your water testing shows that you exceed these values, you can still use your water, as long as you apply an appropriate time interval between the end of irrigation and harvest as determined by calculating the “microbial die-off”.
Clarification of Provisions on Wild Animals
Manure Application Interval Will Be Studied Further
The FDA had previously proposed a nine-month minimum time interval between the application of untreated soil amendments of animal origin (including raw manure) and harvesting. This requirement conflicted directly with the USDA National Organic Program's standards, which require a 120-day interval between the application of raw manure for crops in contact with the soil and 90 days for crops not in contact with the soil. The FDA now proposed to conduct a risk assessment and extensive research to strengthen scientific support for any future proposal. Additionally, the FDA is proposing to eliminate its previously proposed 45-day minimum application interval for compost.
Significant Compliance Costs Remain for Small-scale farms
The provisions reviewed above all were improvements over the original FSMA Produce Rule. The revised rules reduced the estimated number of farms in the United States covered by the FSMA by 4,708, of which 2,885 are “very small”. However, some of the provisions still impose disproportionately high compliance costs on smaller-scale farms, as indicated below in Table A. Smaller-scale farms typically have very constrained cash flows. The added expenses to comply with the FSMA makes their cash flows even tighter and reduces their already low level of profitability. If a "very small" farm loses over a fifth of its net cash farm income, this could have significant impacts on its sustainability. And these decreases do not include the one-time capital expenses that a farm may have to incur, such as to modify restrooms or handwashing facilities and to build fences!
The percentage decrease in net cash farm income attributable to the costs of complying with the FSMA declines as farm size increases. Clearly, there are economies of scale in complying with the FSMA. The FSMA includes delayed implementation of FSMA compliance for smaller-scale farms. Policymakers should also consider providing subsidies and/or no-interest loans for the capital expenditures smaller-scale farms need to make to comply with the FSMA.
Again, please consider submitting comments to the FDA about the proposed FSMA Produce Rule and the Preventive Controls Rule. You can post your comments using the links at the beginning of this article. You can review the FSMA's key revisions summarized on the FDA's FSMA website (http://www.fda.gov/food/guidanceregulation/fsma/default.htm). Also consider reading at least part of the National Sustainable Agriculture Coalition's excellent review of the FSMA.
Understanding the behavior of a pest is very important in developing appropriate control strategies. Information on feeding, host searching, migratory, and reproductive behavior of the invasive Bagrada bug is very limited in published literature. Since Bagrada bug is a fairly new pest in the United States, there is a lot to learn and understand about this pest. Here is a summary of observations about its feeding and reproductive behavior.
Bagrada bugs are primarily attracted to cruciferous crops. However, the number of host species this pest feeds on or passing through is increasing as it spreads to different parts of California. In addition to various wild and cultivated cruciferous plants, Bagrada bugs have been reported to cause damage to carrots, corn, peppers, potatoes, tomatoes, and sunflower. In an earlier choice study where different host plants were offered, neither adults nor nymphs chose tomatoes when alyssum, broccoli, green bean, and wild mustard were among the choices (Dara and Dara, 2013). However, feedback from some growers this year indicated feeding damage to tomatoes (Dara 2014). Although damage was not confirmed, some growers and homeowners reported finding Bagrada bugs on citrus, fig, grape, and strawberry.
Condition of the plants
During a visit to a home garden a couple of years ago, I noticed several Bagrada bugs on dried branches of wild mustard, although different cruciferous vegetable plants were in the proximity. Considering the ability of Bagrada bugs to move around easily, this observation suggests their preference for certain plant conditions. In a recent visit to a 4-week old broccoli field, Bagrada bugs and their damage was noticed only on small and weak plants. Heavy winds a few weeks earlier affected some plants which were significantly smaller than the rest of the plants and were breaking at the base with a slight touch. Similarly, in my lab colony, several bugs are frequently seen on relatively drier plant material although fresh plant material is also present. All these observations suggest that the concentration of plant juices could be influencing Bagrada bugs choice within a specific host. This could mean that maintaining good health of the plants through optimal irrigation and nutrient management is important to avoid weaker plants that could attract Bagrada bugs.
Bagrada bugs are known to hide in the cracks of top soil during cooler parts of the day. Even during warmer parts of the day, some bugs were seen in the soil. This behavior could be exploited by the use of entomopathogens such as Beauveria bassiana and Metarhizium brunneum, which are soilborne fungi. Applied through drip irrigation or as a foliar spray, these fungi can be introduced into the Bagrada bug habitat. Natural behavior of the Bagrada bug to dwell in the soil increases its chances of exposure to fungal inoculum. Although solar radiation might inactivate fungal spores on exposed plant surfaces, being soilborne fungi, these pathogens can persist in the soil for longer periods. Preliminary laboratory assays already demonstrated the potential of these fungal pathogens (Dara 2013).
Based on laboratory observations, Taylor and Bundy (2013) indicated that Bagrada bugs preferred dry soil compared to moist soil to deposit eggs. While this might be the case when Bagrada bugs feed on wild hosts in uncultivated areas, cultivated crops are frequently irrigated and how the soil moisture influences their oviposition behavior in the field conditions is not clear. Earlier literature indicated that eggs are also deposited on various plant parts. Whether eggs are deposited on the plant or in the soil, entomopathogenic fungi could still be important to cause mortality in newly emerged nymphs that might walk on fungal inoculum. If Bagrada bugs overwinter as eggs in the soil, cultivation can be a tool to reduce their numbers. Some entomopathogenic fungi cause egg mortality in addition to infecting mobile stages.
Nature and Numbers
Bagrada bugs have a wide host range and some of their preferred hosts are spread across large areas as wild plants. When these plants dry out, they migrate to crop plants in significant numbers. This is probably why control with pesticide applications alone or using trap crops can be challenging. Some community and home gardeners who tried to use trap crops or traps with alyssum, were able to find large numbers in those crops or traps, but even larger numbers continued to move to crop plants. For a pest like Bagrada bug, exploiting natural enemies appears to be a crucial management tool. Arrangements for foreign exploration of natural enemies are underway.
Dara, S. K. 2013. Bagrada bug update: bioassays and a short video.
Dara, S. K. 2014. Current status of the invasive Bagrada bug in California: geographic distribution and affected host plants.
Dara, S. K. and S. S. Dara. 2013. Bagrada bug host preference: crucifers and green beans.
Taylor, M. and C. S. Bundy. 2013. The life history and seasonal dynamics of Bagrada hilaris in New Mexico. Annual meetings of the Entomological Society of America, Austin, TX.
The workshop opened with a warm welcome from Sonoma County Supervisor David Rabbitt (District 2) and Supervisor Shirlee Zane (District 3) and thoughtful facilitation from Joseph McIntyre with Ag Innovations Network. These leaders “built a foundation of trust, care, and urgency for the work, resulting in a productive and energizing day for the audience and presenters alike,” explained Pamela Swan with Sonoma County's Department of Health Services.
“Many farmers weren't aware of the range of options for value-added production that can help them use the abundance of their harvest, diversify their operations, and generate new income for their ag businesses,” stated UC Cooperative Extension Agricultural Ombudsman, Karen Giovannini. “These emerging opportunities support farmers and food entrepreneurs, as well as regional economic development and help to build a more robust local food system,” added UC Cooperative Extension Food Systems Advisor, Julia Van Soelen Kim.
The workshop was offered as part of the “Opportunities in Ag Business” series presented by UC Cooperative Extension and Sonoma County Department of Health Services and was generously sponsored by American Ag Credit. The workshop complemented the work of the Sonoma County Food System Alliance and helped move forward the goals of the Food Action Plan, the countywide vision for a vibrant local food system.
Can entomopathogenic fungus, Beauveria bassiana be used for pest management when fungicides are used for disease management?
Beneficial fungi such as Beauveria bassiana are pathogenic to insect and mite pests and are commercially available for use in organic and conventional farming. Field studies conducted on commercial strawberry farms with B. bassiana and another entomopathogenic fungus, Metarhizium brunneum show the importance of these microbial pesticides in pest management on conventional farms (Dara 2013, 2014, and unpublished). These studies can make a significant contribution to IPM practices by reducing chemical pesticide use without compromising the pest management efficiency.
In a cropping system where fungicides are frequently applied for managing various foliar diseases such as powdery mildew (caused by Podosphaera aphanis) and botrytis fruit rot (caused by Botrytis cinerea), the fate of a beneficial entomopathogenic fungus is always an important question. Evaluating the compatibility of various fungicides commonly used in strawberries with B. bassiana is necessary to understand the fungicide and beneficial fungus interactions. A series of studies were conducted to address this issue and to explore opportunities to evaluate their compatibility.
In 2012, six bioassays were conducted using fungicides Captan, Elevate, Microthiol Disperss, Pristine Quintec, Rally, and Switch and an organic formulation of B. bassiana (Mycotrol-O) (Dara and Dara, 2013). Mortality and/or infection caused in mealworm (Tenebrio molitor) larvae exposed to surfaces treated with B. bassiana and fungicide was used as a measure of compatibility between the fungicides and the beneficial fungus. Except for Elevate and Quintec, all other fungicides showed moderate to high level of inhibitory effect on the fungus. A follow up study with Pristine showed that increasing the application interval to 1 or 4 days improved the compatibility and resulted in 100% mortality of the mealworms from B. bassiana treatment. Another study was conducted where B. bassiana (BotaniGard EX) was applied 0 to 6 days after fungicides Pristine, Merivon, and Switch were applied (Dara et al. 2014). Switch seemed to have a higher negative impact on B. bassiana than Pristine and Merivon, in general, but the increase or decrease in mealworm mortality with increasing time interval between the fungicides and fungus was variable. Although these two studies indicated that increasing time interval could influence the compatibility of fungicides and B. bassiana,they were conducted only once and warranted additional replicated studies.
A new study was conducted from June to August, 2014 where eight fungicides that had different modes of action were applied at 0 to 6 day intervals to evaluate their impact on mealworm mortality caused by B. bassiana.
Positive control with BotaniGard ES® (B. bassiana)
BotaniGard ES applied 0,1, 2…6 days after treating with Captan.
BotaniGard ES applied 0,1, 2…6 days after treating with Pristine.
BotaniGard ES applied 0,1, 2…6 days after treating with Merivon.
BotaniGard ES applied 0,1, 2…6 days after treating with Microthiol Disperss.
BotaniGard ES applied 0,1, 2…6 days after treating with Rally.
BotaniGard ES applied 0,1, 2…6 days after treating with Rovral.
BotaniGard applied 0,1, 2…6 days after treating with Switch.
BotaniGard ES applied 0,1, 2…6 days after treating with Thiram.
Captan alone applied 0, 1, 2…6 days prior to the exposure.
Pristine alone applied 0, 1, 2…6 days prior to the exposure.
Merivon alone applied 0, 1, 2…6 days prior to the exposure.
Microthiol Disperss alone applied 0, 1, 2…6 days prior to the exposure.
Rally alone applied 0, 1, 2…6 days prior to the exposure.
Rovral alone applied 0, 1, 2…6 days prior to the exposure.
Switch alone applied 0, 1, 2…6 days prior to the exposure.
Thiram alone applied 0, 1, 2…6 days prior to the exposure.
Including the untreated control, there were a total of 114 treatments in each assay. Each treatment had 10 mealworms that were individually incubated in Plexiglas vials with a piece of carrot after a 24 hour exposure to a paper towel treated with B. bassiana, fungicide, or B. bassiana+fungicide applied at different time intervals. Mortality of the worms was observed daily for 6 days. Treatments of fungicides without B. bassiana were also included to see if they have any influence on the mortality of the worms. These assays were repeated three times using medium-sized mealworms purchased from a commercial supplier.
None of the worms in untreated control died during the study. Except for six dead worms out 560 in fungicide only treatments in the first assay, there did not seem to be any impact of fungicides alone on the mortality of mealworms.
Among the fungicides tested, Captan (Mode of action group M4) and Thiram (Mode of action group M3) are the only ones that showed a significant negative impact on B. bassiana resulting in reduced mealworm mortality (Fig. 1, Table 1). Other fungicides had no or negligible impact on B. bassiana. When the average total mortality of the mealworms among different time intervals between B. bassiana and fungicides was considered, Captan caused about 57% reduction and Thiram caused 43% reduction in the efficacy of B. bassiana. Remaining fungicides caused only 0-2% of reduction in the efficacy of B. bassiana. Both Captan and Thiram are broad spectrum fungicide acting through multi-site contact and differ from others, except for Microthiol Disperss (Mode of action group M2), in their modes of action.
Time interval between B. bassiana and different fungicides did not seem to have any impact on the total mortality of mealworms. Although the total mortality caused by B. bassiana ranged from 30-57% in Captan and 33-77% in Thiram treatments at different time intervals, differences were not statistically significant (P > 0.05).
Fig. 1. Average total mortality of mealworms at different time intervals between B. bassiana and fungicides
Table 1. Total mortality caused by B. bassiana when fungicides were applied at different time intervals.
*Means followed by the same letter within each column are not statistically significant (Tukey's HSD P > 0.05). There was no significant difference in values within each row i.e., no difference in time intervals between B. bassiana and any of the fungicides.
This study shows that several of the fungicides commonly used in strawberries are compatible with B. bassiana. When B. bassiana is considered for pest management, Captan and Thiram should be avoided. Fungus-based microbial pesticides play an important role in conventional agriculture and understanding their interaction with fungicides helps with their effective use in pest management.
Dara, S. 2013. Microbial control as an important component of strawberry IPM. February issue of CAPCA's Adviser magazine, pp 29-32.
Dara, S. 2014. New strawberry IPM studies with chemical, botanical, and microbial solutions. February issue of CAPCA Adviser magazine, pp 34-37.
Dara, S. and S.S.R. Dara. 2013. Compatibility of the entomopathogenic fungus, Beauveria bassiana with some fungicides commonly used in strawberries. Strawberries and Vegetables Newsletter (http://ucanr.edu/blogs/blogcore/postdetail.cfm?postnum=9626)
Dara, S. S., S.S.R. Dara, and S. Dara. 2014. Optimal time intervals for using insect pathogenic Beauveria bassiana with fungicides. Central Coast Agriculture Highlights (http://cesantabarbara.ucanr.edu/newsletters/Central_Coast_Agriculture_Highlights50500.pdf)
Average annual precipitation in California is 200 million acre-feet, out of which 42% of water is used for agriculture while 11% is used in the urban areas (municipal and industrial users) and the remaining 47% by the environment (native vegetation, ground water, and oceans) (Doug Parker, personal communication). According to the National Drought Mitigation Center's Drought Monitor, 95% of California is currently in a severe to exceptional drought condition. Drought has impacted California agriculture in different ways in different regions. Depending on crop needs, geographic location, and availability of ground water, production of each crop is affected in one way or the other. Compared to the Central Valley which is affected most by the drought, agriculture on the Central Coast and Southern California is less affected according to a study conducted by the Center for Watershed Sciences at University of California Davis.
Some strawberry and vegetable growers in San Luis Obispo and Santa Barbara Counties were contacted recently to assess the current impact of drought. Their feedback helped to put together the following summary of the current status and recommendations to address drought conditions.
Strawberry growers continue to use available groundwater although with concern for future availability. Current impact of the drought on strawberries:
- Strawberries require 21-24 acre inches of water and rainfall accounts for 3-6 acre inches during normal rainfall years. Rainfall leaches salts away from the root zone while meeting irrigation needs. Compared to three years ago, it is estimated that there is up to a 10% increase in some salts, especially calcium and magnesium due to the current drought conditions. This could lead to 5-10% reduction in fruit yields, but severe salt injury could cause higher losses. Additionally, plants would be vulnerable to pests and diseases which could lead to further yield reduction.
- Strawberries are very sensitive to salinity and frequent irrigation is practiced to prevent the accumulation of salts in the root zone. Growers are aware of diminishing groundwater resources and are carefully monitoring water and salinity levels. Extra irrigation to push out salts from the root zone results in nutrient leaching.
- These practices are expected to continue as long as groundwater is available, but acreage could diminish if groundwater becomes unavailable.
Strategies to address drought conditions in strawberry production:
- Continue to monitor groundwater levels and provide irrigation to meet water needs as well as to leach out salts.
- Monitor health of plants and regularly scout for pests and diseases which might require more timely treatment actions than usual because plants are already under stress.
- Check nutrient levels in the soil and plant and compensate as needed if irrigation is causing nutrient loss.
- Modify leaching fractions based on salt levels and plant maturity to flush salts away from the root zone.
- Reconsider acreage planted based on groundwater availability to minimize losses.
Vegetable growers are experiencing the impact of drought conditions on their production and are currently relying on available groundwater.
- Water needs for vegetables vary from about 7 to 36 acre inches based on the crop and location. Rainfall during a normal season contributes up to 24 acre inches depending on the crop and season.
- Drought conditions resulted in increased salinity, which has caused 10-20% reduction in yields of some crops and a significant increase in pest and disease pressure. Some growers are managing without any yield losses.
- Some growers have already reduced their acreage by 10% or more while others continue to maintain the current acreage.
- Reducing or completely avoiding pre-irrigation is currently practiced by some growers to cope with water shortage. This practice has also increased salinity in the soil and increased weed populations.
- Some growers have reduced fertilizers or are choosing ones with less salt content.
- In order to monitor salinity and nutrient levels, additional expenses are incurred for water, soil, and plant analysis. Increased weed, pest, and disease problems have also increased management costs.
- Some growers are prepared to reduce acreage up to 25% if drought conditions continue.
Strategies to address drought conditions in vegetable production:
- Continue regular monitoring of groundwater levels, salinity conditions, nutrient status, and provide irrigation and fertilizers as appropriate.
- Regularly monitor for pests and diseases and make timely management decisions.
- Reduce or avoid sprinkler irrigation and use drip irrigation as much as possible.
- Continue to reduce or avoid pre-irrigation to conserve water.
- Modify leaching fractions based on the current salt and crop conditions and administer irrigation as needed.
- Modify acreage to suit future water availability.
My current research is evaluating the potential of entomopathogenic fungi in improving water and nutrient absorption by plants, which could play a role in conserving water resources.
Acknowledgements: Thanks to the strawberry and vegetable growers in San Luis Obispo and Santa Barbara Counties who responded to the survey on drought impact and provided their valuable feedback.
UC and other resources:
California agriculture faces greatest water loss ever – College of Agricultural and Environmental Science, UC Davis
Center for Watershed Sciences - UC Davis
Water use in California – Public Policy Institute of California
California harvest much smaller than normal across crops – The Sacramento Bee
In virtual mega-drought, California avoids defeat – Los Angeles Times