FSMA: sweeping changes to our nation’s food safety system

Please submit comments to the FDA by December 15th about how the Food Safety Modernization Act (FSMA) impacts your farm or business; FSMA, passed in 2011, represents the most sweeping changes to our nation’s food safety system since the 1930s. FSMA may have significant impacts on Vermont’s farmers, food producers, and consumers.

In response to the thousands of comments FDA received in response to its first proposed rules, the agency has now released a revised set of rules for public comment. Now is your chance to provide feedback on how these new rules will affect your business and/or your access to fresh, local food. You don’t have to be a policy expert to comment! Whether you’re a farmer, food producer, processor, or consumer, your comments can make a difference.

IMPORTANT: Comments must be submitted by December 15th to be considered!

Click here to learn how to submit your comments online or by mail »

In an effort to help our members draft effective comments to FDA, we’ve put together some guidance and resources on the provisions that will have the greatest impact on NOFA-VT’s farmers, processors and consumer members.

The following provisions of FDA’s revised Produce Safety and Preventive Controls rules have been flagged as areas of concern for organic farmers, small and mid-sized farmers, and anyone engaged in direct-to-consumer marketing. (Scroll to the bottom for a list of additional resources. For a thorough analysis of FDA’s new proposed rules, visit NSAC’s website.)

Manure and Compost. FDA’s original rules would have required a 9-month interval from the application of raw manure to harvest, and 45-day interval from the application of finished compost to harvest. These intervals would have been in direct conflict with National Organic Program (NOP) standards for compost and manure applications, and would have effectively taken some fields out of production. In response to numerous comments from the farming community, FDA has eliminated these restrictions until further research can be conducted to determine appropriate risk-based intervals for raw manure and finished compost applications. During the interim period, we recommend that FDA adopt National Organic Program (NOP) standards for manure and compost applications. NOP standards require a 120-day interval for manure that contacts the harvested crop, a 90-day manure interval for no-contact crops, and a 0-day interval for properly aged compost. Read more about proposed rules for manure and compost »

Qualified Exemption. Under both the original and new proposed rules, certain farmers qualify for an exemption or modified requirements if they sell a significant portion of their produce directly to consumers. The original rules would have allowed FDA to revoke a farm’s exempt/modified status without notice and without a route to regain that status. Under new proposed rules, FDA has specified actions it must take before withdrawing a farm’s exemption and a process for reinstatement of the exemption after withdrawal. The new proposed rules represent a significant improvement, but it is essential that FDA hear from those affected by the qualified exemption provisions that these new rules must be maintained and further clarified in order to provide sufficient protections to farmers.  Read more about qualified exemptions and modified requirements »

Water Testing. FDA’s original proposed rules would have required farmers to test agricultural water every 7 days. The revised rules are an improvement, instead requiring water to be tested 20 times per year. Though they are an improvement, these new water-testing standards are still not based on a science-based risk assessment and will still impose excessively large costs on farmers. We recommend that FDA look to establishGood Agricultural Practices (GAPs) protocol of testing three times per growing season (at or around planting, during peak water use, and at or around harvest) in developing its final water testing requirements.   Read more about proposed rules for agricultural water »

Supplier Verification Program. FDA’s proposed supplier verification program emerged for the first time in its revised Preventive Control rules. Under the new proposed rules, certain facilities will be required to establish supplier verification programs as part of their food safety plan. Though Congress explicitly prohibited FDA from requiring third party audits as part of its Preventive Controls rules, onsite audits are included as a verification activity under new proposed rules. FDA’s new requirements for supplier verification will have especially significant impacts on certain food “aggregators” such as food hubs and farm-to-school programs.  Read more about the proposed supplier verification program »

Environmental Monitoring and Product Testing. Requirements for environmental monitoring and product testing also emerged for the first time in the new proposed rules. FDA’s new proposed rules impose new requirements for environmental testing (primarily for Salmonella and Listeria) in certain circumstances, and product testing (i.e. of raw ingredients or finished products) in others. The costs of these new requirements are projected to be extremely high and, in combination with other costs imposed by FSMA, could put farmers out of business or impede others from going into farming. According to NSAC, for facilities with fewer than 20 employees, the testing requirement alone is expected to cost $12,276 annually. We recommend that anyone whose business could be affected by these rules comment to FDA on the cost prohibitive nature of these new testing/monitoring requirements.    Read more about proposed rules for environmental monitoring and product testing »

Direct-to-Consumer Marketing. Under FDA’s proposed rules, some farms selling directly to consumers through farmers markets, farm stands, and CSAs could fall under the definition of a “facility” and thus be subject to both the Preventive Controls rule and the Produce rule, despite clear language from Congress in FSMA to the contrary. FDA has acknowledged the need to clarify that such direct-to-consumer activities don’t trigger a “facility” designation, and has said it will issue a separate rule to this effect, but the agency has not yet made this important clarification.  Read more about direct-to-consumer marketing »

Share Your Story! Not clear on how FDA’s proposed rules will affect you or your business? FDA needs to hear that too. In your comment, explain where you feel FDA needs to provide further clarification or guidance on its proposed rules. Not sure if you qualify as a farm, a facility, or both? Describing your unique operation in your comments to FDA will help the agency to gain a better understanding of the incredible diversity in food and farming business models. FDA has adopted the mantra “Educate before you regulate.” We believe that education needs to go both ways!

Additional Resources:

• What is FSMA and What Does it Mean for My Farm or Food Business? (Flowchart) [NSAC]
• Top 10 Fixes and Fails in FDA’s Revised Draft Food Safety Rules [NSAC]
• Four Flaws of the FSMA Draft Rules for Produce Growers [Vern Grubinger, UVM Extension]
• Fact Sheet on Preventive Controls Rule [FDA]
• Fact Sheet on Produce Rule [FDA]

If you have any questions, don’t hesitate to contact me.  Please send me a copy of the comments you submit, as it is also very helpful for us to know what is important to you so we can incorporate those concerns into our comments.

Sincerely,

Maddie Monty, NOFA-VT Policy Advisor

FSMA Listening Session with VAAFM and NEASDA

Food safety regulations will affect farmers and food processors throughout the country, and NOFA Vermont has been one of many voices calling for these regulations to be amended to be appropriate for organic and small-scale farms. We hope that concerned farmers, processors, and consumers will continue to make their voices heard, as well. This announcement comes from the Vermont Agency of Agriculture.

The Vermont Agency of Agriculture, Food, and Markets (VAAFM), in conjunction with the Northeast Association of State Departments of Agriculture (NEASDA), will host an open Listening Session on November 17^th, 2014, to offer farmers and food processors an opportunity to provide comment on new supplemental rules proposed by the federal Food Safety Modernization Act (FSMA).

Attendees will have an opportunity to pose questions to and seek clarification from a panel of subject matter experts from the Food and Drug Administration (FDA) that will be present at the meeting. The listening session will take place from 9:00am – 1:00pm in the Chase Center located at the Vermont Law School in South Royalton, VT. While oriented towards regional farmers and food processors specifically, this listening session is open to all interested parties from across the northeast.

FSMA, the most sweeping reform of our nation’s food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. FSMA aims to ensure the safety of the U.S. food supply by shifting the focus from responding to contamination to preventing it. On September 29^th, 2014, the FDA released proposed supplemental rules to four of the seven existing rules, largely the result of an unprecedented level of comments and valuable input received from farmers and others directly affected by these regulations.

The November 17^th, 2014, the Vermont-NEASDA hosted listening session will focus on the following three supplemental rules:

1. The Standards for the Growing, Harvesting, Packing, and Holding of Produce rule proposes enforceable safety standards for the production and harvesting of produce on farms. Changes include:

• More flexible criteria for determining the safety of agricultural water for certain uses and a tiered approach to water testing.
• A commitment to conduct extensive research on the safe use of raw manure in growing areas and complete a risk assessment. Pending those actions, FDA is deferring its decision on an appropriate time interval between the application of raw manure, the harvesting of a crop, and removing the nine-month interval originally proposed.
• The FDA proposes eliminating the 45-day minimum application interval for composted manure that meets proposed microbial standards and application requirements.

2.  The Current Good Manufacturing Practices and Hazard Analysis and Risk-Based Preventive Controls for Human Food rule would require makers of food to be sold in the United States, whether produced at a foreign- or domestic-based facility, to develop a formal plan for preventing food products from causing food borne illness.

3.  Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals would require facilities producing animal food (pet food, animal feed, and raw materials) to have written plans that identify hazards and specify steps to prevent those hazards. Changes include:

• Requirements that human and animal food facilities, when appropriate, test products and the food facility’s environment, as well as implement certain supplier controls.

A full copy of the proposed supplemental rules is available for viewing through the following links:

• Proposed Supplemental Rule for Produce – http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334114.htm
• Proposed Supplemental Rule for Current Good Manufacturing Practices – http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm
• Proposed Supplemental Rule for Preventive Controls for Animal Food – http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm366510.htm

All growers, manufacturers, and anyone interested in fresh produce safety and manufacturing of human and animal food are encouraged to comment on the supplemental proposed rules. The comment period will remain open for 75 days until December 15^th, 2014. There are two ways to officially submit comments to FDA:

1. Comment electronically at:
   1. Produce: https://www.federalregister.gov/articles/2014/09/29/2014-22447/standards-for-the-growing-harvesting-packing-and-holding-of-produce-for-human-consumption
   2. Human Food: https://www.federalregister.gov/articles/2014/09/29/2014-22446/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-human
   3. Animal Feed: https://www.federalregister.gov/articles/2014/09/29/2014-22445/current-good-manufacturing-practice-and-hazard-analysis-and-risk-based-preventive-controls-for-food
2. Written comments may be faxed to the FDA at 301-827-6870 or you may mail them to:

Division of Dockets Management (HFA-305)

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

For more information about FSMA, visit http://www.fda.gov/Food/GuidanceRegulation/FSMA/

Or contact:

Abbey Willard – abbey.willard@state.vt.us or 802-272-2885

Shelley Mehlenbacher – shelley.mehlenbacher@state.vt.us or 802-828-2421

Farmer input wanted on surveys

Agricultural research done in universities and institutions can have a big impact on policy and funding, as well as the development of practical tools, techniques, breeds, and more for farmers. Often one of the first steps in a research project is a survey – to determine the level of need or interest, or to gather a snapshot of perspectives and information. There are a few surveys out at the moment that could use the input of Vermont farmers, and we hope you’ll take a few minutes out of your busy harvest season to fill out one or more.

Survey on Raw Manure Application and Grazing in Fruit and Vegetable Production

Please complete this survey by October 22.

Under the Food Safety Modernization Act (FSMA) the Food and Drug Administration is seeking comments from stakeholders to determine the appropriate interval between application of raw manure/or grazing of animals in certain crops. They are also proposing that farmers who use raw manure to transition to using composted manure. UVM Extension’s Center for Sustainable Agriculture is trying to understand:

• How farmers who grow fruits and vegetables for sale are using raw manure or grazing animals in fruit and vegetable production areas
• How these farmers might be impacted if the recommended interval between the application of raw manure (or grazing animals) in areas where fruits and vegetables are grown, and harvesting the produce is extended
• What barriers may exist for farmers if they were to transition from using raw manure to treated compost

Take the Raw Manure survey by October 22 »

2014 Organic Farmer Seed Survey

The purpose of this survey from the Organic Seed Alliance is to better assess certified organic crop producers’ attitudes and perceptions regarding organic seed. The purpose is also to understand producers’ current use of organic seed and any obstacles that restrict organic seed sourcing. Producers should be prepared to offer best estimates on their organic seed usage or have their seed records on hand. The survey also asks which crops and traits should be prioritized through organic plant breeding programs.

If you are a certified organic crop producer, please take ten minutes to respond to this survey, even if you currently do not use organic seed.

Take the Organic Seed survey »

Survey Regarding the Impact of Regulations on Farming Activities

The focus of this survey from the University of Connecticut is to better understand the state and local regulatory environment for agricultural production within your state.

Take the Farming Regulation survey »

Deadline to #fixFSMA extended to 11/22!

The deadline for comments on the Food Safety Modernization Act has been extended to this Friday, 11/22, due to the issues with the FDA’s web comment portal last week. If you haven’t commented yet, now is your chance!

Click here for our commenting guidelines and a succinct summary of the issues.

FDA Website Down – #fixFSMA mailing info

Update, 11/12: As of now, regulations.gov is running again. You can comment on the Produce Rule here and the Processing Rule here.

Second update, 11/13: We’ve confirmed that written comments need to be postmarked by 11/15, not arrive by then, so if you’d prefer to send something in the mail (or if the website goes down again), you have until Friday. Apologies for the confusion; the information has been updated below.

The FDA’s regulation portal continues to be inaccessible due to “technical difficulties” as the comment deadline for FSMA nears. We are advocating for an extension of the deadline, but cannot say whether it will happen.

You can mail your comment to the FDA, but mailed comments must arrive at the FDA be postmarked by 11/15. That means to guarantee they’ll get there on time, you should mail them today!

Mail to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061, Rockville, MD 20852.

Be sure to include the docket number in your comments: Produce Rule is
FDA-2011-N-0921 and the Facilities/Processing Rule is FDA-2011-N-0920. Also include your name and farm/business or organization affiliation, if any.

Thanks to everyone who is taking the time to make their voices heard!

(For more information on the Food Safety Modernization Act and how to write a comment, see our previous post.)

YOUR comment is needed to #fixFSMA!

If you’re still wondering how FSMA might affect you, read on. The following article originally appeared in the Fall issue of NOFA Notes; we realized it was a good synopsis of the issues most affecting Vermont’s farmers, processors, and consumers, and so are reprinting it here. The deadline to submit comments on the Food Safety Modernization Act (FSMA) is next Friday, November 15.

• View the slides from our recent webinar on how to craft a powerful comment.
• Read sample comments from UVM’s Vern Grubinger and others
• The National Sustainable Agriculture Coalition’s FSMA webpage has in-depth coverage of the bill and what might affect your specific situation, as well as comment guidance and templates for consumers and farmers.

  

  NSAC has useful comment templates for farmers and consumers.

When Congress was debating the Food Safety Modernization Act (FSMA) in 2010, NOFA Vermont joined farm and food advocacy organizations around the country in a successful effort to amend the law to minimize FSMA’s impact on local food systems and family-scale fruit and vegetable farmers.

After all, numerous studies have found that the nation’s food safety “problems” are largely a result of large-scale production, processing, and distribution systems, and not caused by family-scale farms that serve local and regional markets.
President Obama signed FSMA in January, 2011 and handed it to the FDA to figure out how to implement the most sweeping food safety reforms in 70 years. We crossed our fingers. Would the FDA “get it right”? Would Vermont’s fruit and vegetable farmers be able to continue their work without worrying about unnecessary and costly new federal food safety regulations?

FSMA Comment Deadline Fast Approaching!

The deadline to comment on the Food Safety Modernization Act is Friday, 11/15 – less than two weeks away.

Today, we held a webinar in partnership with UVM and the Vermont Agency of Ag to help farmers (and other concerned citizens) craft meaningful and powerful comments.

Click here to view the slides from that presentation. (PDF)

The future of Vermont’s food system will be changed by this bill! Please take the time to make your voice heard.

• Comment on the Produce Rule
• Comment on the Preventative Controls for Processing Rule

To learn more about FSMA and its potential impact, take a look at our previous posts on the subject. We also recommend the National Sustainable Agriculture Coalition’s easy-to-understand “toolkit” of information.

How to submit a FSMA comment that counts: Webinar 11/4

The Food Safety Modernization Act (FSMA) is the most sweeping reform of our nation’s food safety laws in more than 70 years. It was signed into law by President Obama on January 4, 2011, but the specifics of the law are still being worked out, and the public comment period ends on November 15.

When finalized, these rules will affect many Vermont vegetable and fruit growers – large and small. Along with UVM Extension and the Vermont Agency of Agriculture, NOFA Vermont is hosting a webinar for farmers and others that will highlight the elements of a strong comment, give examples of potential talking points for different types of farms (focusing on alternatives to the proposed rules), and walk you through how to submit comments on the Federal Register.

Space is limited. Click here to reserve your Webinar seat for November 4th from 12 -1 pm.

PLEASE NOTE: The purpose of the webinar is NOT to explain the details of FSMA, but to help you submit your comments. If you are not familiar with FSMA, please use one of the following resources to learn more beforehand.

• National Sustainable Agriculture Coalition toolkit
• American Farmland Trust webinar
• Factsheet from Vern Grubinger
• Previous updates from NOFA Vermont

FSMA: Learn More and Speak Out! Webinar on 10/10

FSMA: Learn More and Speak Out! Webinar on 10/10

Learn more about the Food Safety Modernization Act and how you can speak up for small farmers with this webinar on Thursday at 4:30 from the National Sustainable Agriculture Coalition. This is intended especially for farmers and supporting organizations that need to get up to speed on the basics of the FSMA and how to take action.

A New England Education for the FDA

When the FDA team responsible for implementing the Food Safety Modernization Act (FSMA) came to New Hampshire and Vermont last week, they got an earful — and an education. At an August 20th Listening Session at Dartmouth College, about two hundred vegetable and fruit farmers, food processors, local food advocates, and consumers showed up to tell the visitors from inside the Beltway of the many ways in which the FDA’s proposals for new food safety regulations would affect them.  Farmers and others, including NOFA Vermont’s Fruit and Vegetable Technical Assistance Advisor Lynda Prim, stood in line for an hour or more for the chance to detail increased production costs, harms to the environment, and economic disincentives, especially on smaller-scale operations.

Those who presented remarks voiced a number of specific concerns. Many pointed out that the FDA’s proposed requirement that farmers test irrigation water weekly was unnecessary, impractical, and would increase costs significantly. Others pointed out negative consequences on wildlife and biodiversity on farms.

Lynda Prim joined a number of organic farmers present in voicing concern about conflicts between proposed FSMA requirements and the National Organic Program rules, despite the fact that the FDA is explicitly directed to avoid such conflicts. For instance, proposed requirements for waiting periods before crops can be harvested after field applications of manures (270 days) and compost (45 days) greatly exceed, and are in direct conflict with, such waiting periods required by the National Organic Program. Additionally, these extended waiting periods are impractical in New England’s short growing season, and would likely increase the use of chemical fertilizers on non-organic farms. Farmers’ incomes and the environment would be negatively affected.

Many spoke of how increased compliance costs — estimated by the FDA to run to thousands of dollars annually on even small-scale operations — would either force them to leave farming entirely or significantly damage opportunities for farm expansion and new farm enterprises. Such specific, informed and heartfelt criticisms of the proposed regulations continued for over two hours straight.

Later that day and the next, the FDA team visited local farms and food businesses, including the Mad River Food Hub and Hartshorn Farm in Waitsfield, and the Intervale Farm in Burlington. They got a first-hand look at the diversity of farming practices, production systems, distribution and marketing innovations that are critical to the continued development of our emerging local food economy in the region. (You can see their impressions of the visit on the FDA’s blog.)

Throughout their visit, the members of the FDA team listened intently. They had a lot of questions and asked for advice and recommendations. More than once, Michael Taylor, the FDA Deputy Commissioner who led the team, indicated that he wanted to make sure that the vigor of local farms and the local food economy would not be derailed by burdensome and unnecessary food safety regulations. We agree, and hope to see his statements translated into action when the final regulations are published next year.

Our visitors are now back at their desks in D.C.. But farmers, organizations, consumers and businesses throughout the country have until November 15 to submit their own written comments expressing their concerns about proposed regulations, as well as their recommendations for improving them. The FDA is, by law, required to read and consider every one of these written comments before it develops and publishes its final food safety regulations in the next year or so. It’s up to all of us to make sure it’s a highly educational experience for them.

More information about the proposed rules and how to submit your own comments can be found in our earlier post on the the FSMA. NOFA Vermont and Vermont Organic Farmers are working on an official comment of our own; stay tuned to learn more.

[by Dave Rogers, NOFA Vermont Policy Advisor]