Posts Tagged: Food Safety Modernization Act

Food Safety Modernization Act Comments Due December 15, 2014

The Food Safety Modernization Act

In late September, 2014, the FDA released a modified set of draft regulations for the Food Safety Modernization Act's (FSMA) Produce Rule and the Preventive Controls for Human Food Rule; they had been revised considerably in response to extensive comments submitted by farmers and organizations during 2013.

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

The FDA has revised its definition of covered farms. It is now proposing that farms or farm mixed-type facilities with average annual gross revenues of $25,000 or less from produce sales will not be covered by the Produce Rule. Originally, the proposed rule related to all farm sales; thus, a small-scale wheat farmer seeking to diversify by growing a few rows of tomatoes would have been covered by the rule.

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:

1. 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
2. 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:

1. 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;
2. Comply with the “compliance and enforcement requirements” of the Produce Rule; and
3. 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.

However, if these activities are done off of a farm, such as when farms collaborate to have a jointly controlled packing operation, these activities will trigger the manufacturing/processing definition above and would mean that you operate a “facility”. As a facility, the farm would be required to establish and implement hazard analysis and risk-based preventive controls for human food. FDA is currently seeking comment on whether the Preventive Rule should require a “facility” to: (a) conduct product testing to verify implementation and effectiveness of preventive controls; (b) conduct environmental monitoring to verify implementation and effectiveness of preventive controls if contamination of a ready-to-eat food with an environmental pathogen is a significant hazard; and (c) require supplier controls when the receiving facility's hazard analysis identifies a significant hazard for a raw material or ingredient, and that hazard is controlled before the facility receives the raw material or ingredient from a supplier. Clearly, these requirements would be considerably more complex and expensive to comply with than the requirements of the Produce Rule for farms.

Revised Water Quality Standard and Testing Are More Flexible

The FDA is proposing various revisions to the microbial standard for water that is directly applied during the growing of produce (other than sprouts). The agency is updating the microbial quality standard to reflect data that supports the EPA's 2012 recreational water quality criteria.

For farms that have to test their water, the FDA is proposing three numerical standards below for testing.

1. 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.
2. 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.
3. 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

Numerous organizations and farmers have protested that the FDA's proposed rules would harm wildlife, including forcing farmers to exclude animals from growing areas or destroying animal habitats. The FDA has clarified that its proposed produce rules does not authorize or require farms to take actions that would constitute the taking of a threatened or endangered species in violation of the Endangered Species Act.

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.

Part Two: Your Input is Needed on the Food Safety Modernization Act (FSMA)

In early January, 2013 the FDA issued two sets of proposed regulations related to the Food Safety Modernization Act (FSMA) that could have significant impacts on farmers—small- and large-scale: the Produce Rule and Preventive Controls Rule for Human Food.  The deadline for comments has been extended twice; it appears that November 15, 2013 will be the final deadline.  Links and more information about submitting your comments to the FDA are below.

As I work on drafting my comments to submit to FDA about these proposed rules, it would helpful to get your input about the proposed rules. Please send your comments by November 8 to: shermain@primal.ucdavis.edu. Please share your thoughts about how the proposed rules would impact your farming operation.

Below, I have summarized some key provisions and provided links to other sources. I hope that you can take some time to review this information. FDA’s proposed rules could have a significant impact on your farming operation.

Proposed Rule on Preventive Controls for Human Food

Background

The Rule on Preventive Controls for Human Food (Preventive Controls Rule) proposes that firms have written plans in place to identify potential hazards, put in place steps to address them, verify that the steps are working, and outline how to correct any problems that arise. The Preventive Controls Rule would apply to facilities (including farms) that manufacture, process, pack or hold human food.  Specifically, the rule applies to farms that are considered to be a “farm mixed –type facility”. Such farms grow and harvest crops or raise animals, AND handle crops that are not grown, raised, or consumed on any farm they own, AND/OR they pack, process or hold food produced on their farms that is not consumed on any farm they own. 

The rule requires each facility covered by the rule to prepare and implement a written food safety plan, which would include the following: hazard analysis; risk-based preventive controls; monitoring procedures; corrective actions; verification; and recordkeeping.

These are some problems I see with the Proposed Rule on Preventive Controls:

Clarification is needed

The proposed Preventive Controls Rule includes provisions for exemptions and modified requirements. However, they are extremely difficult to understand. The relevant sections of the rule need to be clarified, as well as the associated guidance documents and educational materials.

Packing and Holding Activities should be explicitly exempt

Packing, sorting, grading and storing produce grown on the farm does not trigger the manufacturing/processing definition; however, these same activities involving produce grown on another farm classifies the farm as a “farm mixed-type facility”.   These low-risk activities should be explicitly exempted from the requirements of the proposed rule.

Community Support Agriculture (CSA)s, Farmers Markets and Farm Stands must be explicitly identified as retail food establishments

The Food Safety Modernization Act includes language that specifically instructs the FDA to amend the definition of a retail food establishment to include CSAs, farmers markets and roadside farm stands. Under pre-existing law, retail food establishments are not “facilities” anddo NOT have to register with the FDA (the definition of “facility” as used in FSMA comes from that used in the Bioterrorism Act). However, this amended definition is not included in the FDA’s Preventive Controls rule. The FSMA Facts document—I Have a Farm--Does the Proposed Preventive Controls Rule Affect Me? (http://www.fda.gov/downloads/Food/GuidanceRegulation/ FSMA/UCM365377.pdf) states:

“FDA intends[1] to amend the definition of “retail food establishment” to clarify that, in determining the primary function of an establishment, the sale of food products directly to consumers includes:

o   Sales of food to consumers at a roadside stand or farmer’s market and

o   Sale and distribution of food through a community –supported agriculture program.”

It is curious, nevertheless, that FDA did not simply include a similar statement in the proposed rule, despite the specific instructions in the FSMA. Furthermore, the word “intends” does not project the same level of certainty or commitment, as would a mandatory word such as “shall”.

Thus, CSAs and roadside stands that handle produce from another farm could be subject to the same manufacturing-related regulations as a large-scale fruit cannery; they would have to register with the FDA and comply with Hazard Analysis/Preventive Controls requirements. This vulnerability must be eliminated by including an amended definition of a retail food establishment within the proposed rule.

Key links regarding the Proposed Rule on Preventive Controls for Human Food:

Summary by FDA:http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM360735.pdf

Summary by National Sustainable Agriculture Coalition: http://sustainableagriculture.net/fsma/overview-and-background/what-is-the-preventive-controls-rule/

          Check out if it applies to you as a farmer: http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM365377.pdf

 Text of Proposed Rule: http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0920-0001

 Comment on the Proposed Preventive Controls Rule: (click on the blue box in the upper right- hand corner: http://www.regulations.gov/#!submitComment;D=FDA-2011-N-0920-0188

Please send your thoughts about how the proposed rules would impact your farming operation by November 8 to: shermain@primal.ucdavis.edu. I would like to incorporate them (without identifying the source) into my response to the FDA.

 

 

Your Input is Needed on the Food Safety Modernization Act (FSMA)

In early January, 2013 the FDA issued two sets of proposed regulations related to the Food Safety Modernization Act (FSMA) that could have significant impacts on farmers—small- and large-scale: the Produce Rule and Preventive Controls Rule for Human Food.  The deadline for comments has been extended twice; it appears that November 15, 2013 will be the final deadline.  Links and more information about submitting your comments to the FDA are below.

 As I work on drafting my comments to submit to FDA about these proposed rules, it would helpful to get your input about the proposed rules. Please send your comments by November 8 to: shermain@primal.ucdavis.edu.  Please share your thoughts about how the proposed rules would impact your farming operation.

Below, I have summarized some key provisions and provided links to other sources. I hope that you can take some time to review this information. FDA’s proposed rules could have a significant impact on your farming operation.

Proposed Produce Rule

Background

The proposed Produce Rule covers all fruits and vegetables, except those rarely consumed raw (such as artichokes, cranberries, eggplant, kidney beans and potatoes—see Sec. 112.2(a)(1) of the proposed rule-pp.484-485), produced for personal consumption, or destined for commercial processing that will reduce microorganisms of public health concern. It is focused on the following five areas of risk related to crop production, harvesting and storage:

• agricultural water;
• biological soil amendments;
• health and hygiene;
• domesticated and wild animals; and
• equipment, tools and buildings.

A farm may establish alternative standards to certain of the proposed rule’s requirements related to water and biological soil amendments of animal origin. However, the alternatives must be scientifically established to provide the same amount of protection as the requirement in the proposed rule without increasing the risk of adulteration.

The proposed Produce Rule would not apply to farms that have an average annual value of food sold during the previous 3-year period of $25,000 or less. Small farms above this sales limit would be eligible for the qualified exemption; to qualify they must meet all of the following conditions during the previous 3-year period preceding the applicable calendar year:

1. Average annual revenues from all farm sales (not just the covered produce crops) is less than $500,000 (adjusted for inflation);

2. Average annual revenues from products sold directly to consumers, retail food establishments and restaurants exceeded the average annual revenues of the farm’s sales to all other buyers; and

3. These direct sales occurred in the same state as the farm, or within 275 miles of the farm (whichever is the greater distance).

However, all farms, including exempt and qualified exempt small farms, must comply with the Produce Rule's labeling requirement (Section 112.6). Specifically, if a food packaging label is required on the food, the label must "...prominently and conspicuously display, at the point of purchase, the name and complete business address of the farm where the produce was grown." If a food packaging label is not required, the farm 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." The complete business address must include the street address or post office box, city, state, and zip code.

These are some problems I see with the Proposed Produce Rule:

Agricultural Water Testing Requirements are burdensome and not based on science

 The FSMA called for rules developed based on “…science-based minimum standards”.  However, in its proposed Produce Rule, FDA states that “there is a lack of sufficient information to support a pathogen-based microbiological standard for water used in the production of produce…” (p.3563).  Given this fact, it seems inappropriate and very unreasonable that the proposed rule imposes weekly water testing requirements when surface water is used for irrigation during the growing season.  The proposed food safety standard is not risk-based; there is no science to support the testing for the presence of generic E. coli as an indicator of the risk of fecal contamination. 

FDA estimated that each water test costs $80 if the laboratory collects the water sample; this cost includes the laboratory’s travel, analysis, and collection costs. If the grower collects the sample, the estimated test cost rises to $94.60. Many smaller farmers in California have long growing seasons; a grower with a 30-week growing season could spend $2,400 per field for such testing, if he or she is fortunate enough to find a lab that will come out to the farm. 

Soil Amendment Requirements conflict with organic practices

The FSMA explicitly states that the proposed rules developed by FDA “…in the case of production that is certified organic, not include any requirements that conflict with or duplicate the requirements of the national organic program established under the Organic Foods Production Act of 1990…”. However, the proposed FDA rule for untreated manure requires that there is a minimum application interval between application and harvest of 9 months. This is much longer than the standards set by the USDA National Organic Program (NOP) of 90 or 120 days.  Similarly, the interval from application to harvest of treated manure in the proposed FDA rule is 45 days, while the NOP does not require an interval between application and harvest for manure treated by a composting process consistent with the NOP’s standards.

Compliance with the Proposed Produce Rule can be expensive

FDA estimated that compliance with the proposed Produce Rule will cost domestic farms $459.6 million annually.  The proposed Produce Rule challenges the financial viability of California’s small farms. According to the most recently published Census of Agriculture (2007), very small and small farms in California operate, on average, with very small margins.  As shown in Table A below, adding the estimated average first year cost to comply with the Produce Rule reduces the very small farm’s net cash farm income (NCFI) by 73.0%, and by 41.6% for the annual average. For a large farm, the average impact of the cost of complying with the Produce Rule on its NCFI is only a 4.1% loss for the first year and 3.3% for the annual average.

Table A

1^st Year and Annual Average Impact of Produce Rule Compliance Costs

On Average Net Cash Farm Income by Farm Size

	Very Small ($25,000-$249,999)	Small ($250,0000-$499,999)	Large ($500,000) & over
Average Annual NCFI1	$11,305	$77,159	$933,189
Average  Annual Cost per farm	$4,697	$12,972	$30,566
Average  1st Year Cost per farm	$8,260	$20,470	$38,133
NCFI – 1st Year Cost	$6,608	$56,689	$895,056
NCFI – Annual Cost	$3,046	$64,187	$902,623
1st year NCFI decrease (%)	73.0	26.5	4.1
Average annual NCFI decrease (%)	41.6	16.8	3.3

[1] Source: USDA-National Agricultural Statistics Service. 2007 Census of Agriculture

Below are some key links for the proposed Produce Rule:

Summary  by FDA: http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM359258.pdf

Summary by National Sustainable Agriculture Coalition:

http://sustainableagriculture.net/fsma/overview-and-background/what-is-the-produce-rule/

Text of Proposed Rule:

http://www.fda.gov/downloads/Food/GuidanceRegulation/FSMA/UCM360734.pdf

          Comment on the proposed Produce Rule: (click on the blue box in the upper right-hand corner)

          http://www.regulations.gov/#!documentDetail;D=FDA-2011-N-0921-0199

 

Please send your thoughts about how the proposed rules would impact your farming operation by November 8 to: shermain@primal.ucdavis.edu. I would like to incorporate them (without identifying the source) into my response to the FDA.

My following post will address the Proposed Rule on Preventive Controls for Human Food

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