UPDATE: FOOD SAFETY BILL FIGHT CONTINUES
Last week, the Senate passed S510, the Food Safety Modernization Act, with the Tester-Hagan amendment. Almost immediately, members of the House of Representatives raised objections that S510 includes provisions for user fees, which they argued were revenue raising provisions that violated the Constitutional requirement that all tax provisions originate in the House.
No one in the Senate apparently noticed this problem, yet unnamed House members supposedly spotted it within hours. Other bills that have originated in the Senate have included user fees and passed without objection. There may be Constitutional problems with the provisions, but it also may be a maneuver to stall the bill in order to make changes.
With the clock ticking on the lame duck session, the procedural objections might finally kill this bill. But don't count on it! The SAME day that the procedural objections were announced, Agribusiness lobby groups sent letters urging House members to conference S510 with HR 2749 (the House version), for the single specific purpose of stripping out the Tester-Hagan amendment. Until the procedural objections were raised, the House leadership had pledged to bring S510 to a vote without conferencing the bills. It's suspicious that the Agribusiness groups were prepared to immediately take advantage of the delay to try to remove the protections of the Tester-Hagan amendment.
To quote from Agribusiness: one letter was signed by produce industry groups, which represent the majority of fresh fruits and vegetables sold in the United States, while the second letter was sent by organizations that represent the vast majority of growers, producers, shippers, distributors, processors, packers, and wholesalers. In other words, these lobby groups represent the industrial food system that has been the source of the problems. Yet they are working to convince House members to impose the same regulations on local farmers market producers as on their huge corporate operations.
To be clear, we dont think S.510 is a good bill even with the Tester-Hagan amendment. It increases FDA's power, which will undoubtedly lead to even more battles between FDA and local food producers and consumers. FDA has abused the powers it already has, and that will almost certainly continue, with or without this bill. But as bad as the bill is now, it would be even worse without the amendment.
Agribusiness's real concern about the Tester-Hagan amendment isn't food safety, but the precedent set by having Congress recognize that small, direct-marketing producers are different, and should be regulated differently, from the large Agribusinesses.
TAKE ACTION
Please CALL or EMAIL your Congressman! You can call the Capitol Switchboard at (202) 224-3121 or go to http://www.house.gov/htbin/zipfind to find their website (if the phone lines are busy, the best way to reach them is through the Contact page on their website)
Message: My name is ____, and I am a constituent who is concerned that FDA will abuse its new authority under the food safety bill to hurt small farmers and local food producers. IF the food safety bill passes, it's critical that it at least include the Tester-Hagan amendment to protect small-scale producers from the regulations for hazard analysis plans and growing and harvesting standards. And whether this bill passes or not, I want my Congressman to take steps to rein in the FDA's abuses, through limiting appropriations and overseeing the agency's rulemaking. I would like to talk with you more about this, please call me back at ________.
MORE INFORMATION
The structure and language of the Tester-Hagan amendment is complex because every piece of this amendment was fiercely fought by the opponents. To be understood, the amendment needs to be read in the context of S510 and the existing background law, including the 2002 Bioterrorism Act.
Here are some of the key provisions of the amendment:
* For farmers selling fresh fruits and vegetables: if the producer grosses under half a million dollars, adjusted for inflation, and sells at least half of their produce directly to qualified end users (see below), then the farmer is exempt from the produce safety standards (i.e. regulations in which FDA would tell farmers how to grow and harvest their crops). See pages 16-19 of the amendment. Note that the FDA has already started working on these growing and harvesting standards, and claims that the existing law -- without S510 or Tester-Hagan -- gives it authority to impose the standards on ALL farmers.
* For farmers and producers who sell processed or value-added foods: if they sell more than half of their products directly to individual consumers, they do not have to register with the FDA nor develop a hazard analysis plan. This is due to the provision entitled clarification of intent that directs FDA how to define retail food establishments, see pages 1-2 of the amendment.
* For farmers and producers who sell processed or value-added foods, but do not sell more than half of their products directly to individual consumers: they are ALREADY under a legal requirement to register with the FDA due to the 2002 Bioterrorism Act. The Tester-Hagan amendment provides that these producers can avoid having to comply with S510s extensive requirements for hazard analysis plans by:
1) Submitting documentation that they gross under half a million dollars, adjusted for inflation, and sell more than half their products directly to qualified end users (see below), and
2) EITHER providing documentation that they comply with state and local laws such as a copy of their commercial kitchen license OR preparing a simplified hazard plan. See pages 5-6 (the or is found on line 4 of page 6)
* Qualified end users are (a) individual consumers, WITHOUT any restriction on their location or proximity to the producer, and (b) restaurants and retail food establishments that are either in-state OR within 275 miles. The farmers and producers will NOT have to ask individual consumers where they come from. See pages 7-8 & 18.
* The $500,000 limit on the exemptions is adjusted for inflation. See page 5, lines 13-14, and page 16, line 12
* The amendment also directs FDA to conduct a study that would, for the first time, look at the issues of scale and type of processes in relation to foodborne illness. The directive to do a study is the first attempt to get data to show that smaller-scale producers who don't commingle their products and who do less processing and transportation produce safer food. The bill does NOT mandate that any individual person hand over the information to the government. The FDA is also directed to use the results of the study to define very small businesses that will also be exempt from the hazard analysis plan requirements.
You can read the Tester-Hagan amendment for yourself at http://tester.senate.gov/Legislation/upload/tester_amendment_agreement.pdf
Tuesday, December 7, 2010
Monday, November 22, 2010
Update on Food Safety Legislation
Agribusiness shows its true colors!
Last week, the Senate voted 74-25 to move to consideration of S.510, the Food Safety Modernization Act. After thirty hours of debate and behind-the-scenes negotiations, the Senators released a final Managers Amendment that includes a compromise version of the Tester-Hagan amendment. Thank you to all our members who have called and written over the last several months to help protect local foods!
But even though an agreement was reached on the Tester-Hagan amendment last week, the issue is still not over. The final vote on the bill has been delayed until Monday, November 29, due to disagreements over amendments relating to the health care bill and a ban on earmarks. And, in the meantime, Agribusiness has shown its true colors.
For over a year, the big Agribusiness trade organizations have supported passage of S.510. From Agribusinesss perspective, the bill was a win-win: they could absorb the costs of the regulations because of their size; they'd gain good PR for supposedly improving food safety practices; and the competition created by local food producers, which is rapidly growing, would be crushed by the regulatory burdens.
This was only speculation until now. But when the Senators agreed to include the Tester-Hagan amendment in the bill, to exempt small-scale direct-marketing producers from some of the most burdensome provisions, twenty Agribusiness trade organizations fired off a letter stating that they would now oppose the bill.
The letter from the Agribusiness groups states: [B]y incorporating the Tester amendment in the bill, consumers will be left vulnerable to the gaping holes and uneven application of the law created by these exemptions. In addition, it sets an unfortunate precedent for future action on food safety policy by Congress that science and risk-based standards can be ignored.
http://www.unitedfresh.org/assets/files/Letter%20on%20Passage%20of%20S%20%20510%20and%20Tester%20Amendment.pdf
What science and risk? No one has produced any data or evidence of any widespread problems caused by local producers and marketed directly to consumers. All of the major food-borne illness outbreaks have been caused by products that went through the long supply chains of Agribusiness.
Agribusinesss real concern about the Tester-Hagan amendment isn't food safety, but the precedent set by having Congress recognize that small, direct-marketing producers are different, and should be regulated differently than large Agribusinesses.
Agribusiness is trying to convince the Senators to pull the Tester-Hagan amendment back out. While the amendment is currently part of the Managers Package the amended version of the bill agreed to by six bipartisan sponsors nothing is certain until the actual vote.
ACTION TO TAKE
This Thanksgiving week, please take a moment to call or email your Senators to tell them to hold firm on KEEPING the Tester-Hagan amendment part of the bill.
You can call the Capitol Switchboard at 202-224-3121 or go to www.senate.gov to find their website (if the phone lines are busy, the best way to reach them is through the Contact Page on their website)
Last week, the Senate voted 74-25 to move to consideration of S.510, the Food Safety Modernization Act. After thirty hours of debate and behind-the-scenes negotiations, the Senators released a final Managers Amendment that includes a compromise version of the Tester-Hagan amendment. Thank you to all our members who have called and written over the last several months to help protect local foods!
But even though an agreement was reached on the Tester-Hagan amendment last week, the issue is still not over. The final vote on the bill has been delayed until Monday, November 29, due to disagreements over amendments relating to the health care bill and a ban on earmarks. And, in the meantime, Agribusiness has shown its true colors.
For over a year, the big Agribusiness trade organizations have supported passage of S.510. From Agribusinesss perspective, the bill was a win-win: they could absorb the costs of the regulations because of their size; they'd gain good PR for supposedly improving food safety practices; and the competition created by local food producers, which is rapidly growing, would be crushed by the regulatory burdens.
This was only speculation until now. But when the Senators agreed to include the Tester-Hagan amendment in the bill, to exempt small-scale direct-marketing producers from some of the most burdensome provisions, twenty Agribusiness trade organizations fired off a letter stating that they would now oppose the bill.
The letter from the Agribusiness groups states: [B]y incorporating the Tester amendment in the bill, consumers will be left vulnerable to the gaping holes and uneven application of the law created by these exemptions. In addition, it sets an unfortunate precedent for future action on food safety policy by Congress that science and risk-based standards can be ignored.
http://www.unitedfresh.org/assets/files/Letter%20on%20Passage%20of%20S%20%20510%20and%20Tester%20Amendment.pdf
What science and risk? No one has produced any data or evidence of any widespread problems caused by local producers and marketed directly to consumers. All of the major food-borne illness outbreaks have been caused by products that went through the long supply chains of Agribusiness.
Agribusinesss real concern about the Tester-Hagan amendment isn't food safety, but the precedent set by having Congress recognize that small, direct-marketing producers are different, and should be regulated differently than large Agribusinesses.
Agribusiness is trying to convince the Senators to pull the Tester-Hagan amendment back out. While the amendment is currently part of the Managers Package the amended version of the bill agreed to by six bipartisan sponsors nothing is certain until the actual vote.
ACTION TO TAKE
This Thanksgiving week, please take a moment to call or email your Senators to tell them to hold firm on KEEPING the Tester-Hagan amendment part of the bill.
You can call the Capitol Switchboard at 202-224-3121 or go to www.senate.gov to find their website (if the phone lines are busy, the best way to reach them is through the Contact Page on their website)
Saturday, October 2, 2010
Action Alert Regarding Food Safety Legislation
URGENT ACTION ALERT
FOOD SAFETY LEGISLATION MOVING TOWARDS SENATE VOTE
The Senate has returned home without voting on S.510, the Food Safety Modernization Act, but unfortunately the bill is still alive. Before returning home, the Senate started the process to bring S.510 to the floor for a vote, and it is likely that they will finally vote on it shortly after they re-convene on November 15.
This bill greatly expands FDAs authority over both processed foods and fresh fruits and vegetables, and would give FDA authority to impose extensive, burdensome requirements on even the smallest processing facilities and farms who sell to local consumers.
We need the Tester-Hagan amendment to protect our vulnerable local businesses!
The Senators are back in their home States for the election season. This is an important time to publicize this issue and get their commitment to support the Tester-Hagan amendment!
ACTION TO TAKE
1) Contact your Senators local office. You can find your Senators contact information at www.Senate.gov . Call and ask them if the Senator will be attending any events near you, so that you can meet with them.
Urge your Senators to:
a)Support the Tester-Hagan amendment to exempt small-scale, local producers, AND
b)Oppose the addition of criminal penalties unless there is actual harm to human health
2)Educate your community by writing a letter to the editor. See the sample below
SAMPLE LETTER TO THE EDITOR
NOTE: It is VERY important to write your own, personal letter to the editor. Newspapers will NOT print form letters! The letter below is simply to provide you with some ideas. Remember to keep your letter short (100-150 words) and try to connect it with you, your family, and/or your community.
Dear Editor:
The U.S. Senate is likely to vote on a Food Safety bill (S. 510) when it reconvenes after the election. Unfortunately, as the bill is currently written, small local farms and processing facilities will come under a sweeping new industrial regulatory standard that threatens to put many of them out of the food business. These small producers provide food for our local community through CSAs, farmers markets, and local co-ops.
Sen. Jon Tester (MT), with Sen. Kay Hagan (NC), has an amendment to exempt small, direct-marketing farms and facilities. This amendment is critical to protecting local food systems and giving consumers a choice to buy fresh local products. It would be counter-productive and deeply disturbing if a bill designed to curb the abuses of Big Agribusiness snuffs out local food businesses as an "unintended consequence." Please call your Senators to urge them to vote for the Tester-Hagan amendment.
Signed,
Name
City, State
MORE INFORMATION
All of the well-publicized incidents of contamination in recent years including the recent egg recall occurred in industrialized food supply chains that span national and even international boundaries. The food safety problems in this system can and should be addressed without harming the local food systems that provide an alternative for consumers.
The growing trend toward healthy, fresh, locally sourced vegetables, fruit, dairy, and value-added products improves food safety by providing the opportunity for consumers to know their farmers and processors, to choose products on the basis of that relationship, and to readily trace any problems should they occur.
Farmers and processors who sell directly to consumers and end users have a direct relationship with their customers that ensures quality, safety, transparency and accountability. In addition, small-scale food producers are already regulated by local and state authorities, and the potential risk their products pose is inherently limited by their size. For these farmers and processors, new federal requirements are unnecessary and would simply harm both the food producers and their consumers.
Although S. 510 includes some provisions for flexibility for small and diversified producers and processors, the bills new hazard analysis and risk-based preventive controls would affect these facilities and authorize FDA to dictate growing and harvesting practices for produce. These requirements will impose significant expenses and burdens on individuals and small businesses.
Below are answers to some of the frequently asked questions.
QUESTION: What would S.510 do to farmers?
S.510 authorizes FDA to issue standards for production and harvesting of fruits and vegetables. Given the agencys track record, it is likely that the regulations will discriminate against small, organic, and diversified farms. While the bill directs FDA to consider the impact of its rulemaking on small-scale and diversified farms, there are few enforceable limits to protect small, sustainable farms from inappropriate and burdensome federal rules.
The only enforceable limit is that FDA's new regulations cannot contradict the regulations for certified organic producers. But many local food producers are not certified organic. And even certified organic can still be subject to additional regulations by FDA imposing impractical or unfair burdens, so long as the regulations dont directly contradict the organic regulations.
The Tester-Hagan amendment would exempt farms that have gross sales under $500,000 and that sell more than half of their produce directly to consumers and other qualified end users such as local restaurants and local stores.
QUESTION: Are direct marketing farms exempt from the bill?
No, direct-marketing farmers are not exempt from the produce safety standards. Under the bill as currently written, all farmers raising produce are subject to the produce safety standards (section 105 of the bill), regardless of how they market their fruits and vegetables.
The Tester-Hagan amendment is needed to protect direct marketing produce farmers from being told how to grow and harvest their crops by FDA bureaucrats.
QUESTION: What does S.510 require of people who process food?
Under S.510, anyone who processes food for sale would have to comply with extensive new regulations over every step of its process. This includes people who make such things as jam, bread, and cheese for local markets. S. 510 would require that all facilities would have to comply with a Hazard Analysis and Risk-Based Preventative Controls, which would require:
--Hazard analysis: Identify and evaluate known or reasonable hazards and develop written analysis of the hazards.
--Preventive Controls: Identify and implement preventive controls, to provide assurances that hazards indentified will be significantly minimized and prevented.
--Monitor effectiveness of the preventive controls.
--Establish procedures that a facility would implement if the preventive controls are found to be ineffective through monitoring.
--Verify that the preventive controls are adequate; that monitoring is in accordance with 103(d); that the owner is making appropriate decisions about corrective actions under 103(e); that the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards, including the use of environmental and product testing programs; that there is documented, periodic reanalysis of the plan to ensure that it is still relevant.
--Recordkeeping: Maintain, for not less than two years, records documenting the monitoring of the preventive controls implemented, instances of nonconformance, the results of testing, instances of corrective actions, and the efficacy of preventive controls.
--Written plan and documentation: Prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection 103(b) and identifying the preventive controls adopted under subsection 103(c) to address those hazards.
All of this would be subject to FDA approval, inspections, and fees for re-inspection. The paperwork burdens would drive many small-scale processors out of business.
The Tester-Hagan amendment would exempt processors that have gross sales under $500,000 and that sell more than half of their products directly to consumers and other qualified end users such as local restaurants and local stores. The amendment also exempts very small businesses, to be defined by FDA.
QUESTION: I heard that S.510 doesnt require anyone to register who isnt already required to do so. Is that true?
Technically, S.510 does not change the law on registration. But, in practical terms, there are thousands of small-scale processors who are not even aware that they have to register who will now be subject to extensive new requirements.
In 2002, Congress required all food facilities to register with the FDA under the Public Health Security and Bioterrrorism Preparedness and Bioterrorism Response Act of 2002. The rationale for such a sweeping federal reach into the smallest of food facilities was national security and bioterrorism.
While S.510 does not add new registration requirements, the reality is that there are many small-scale facilities that have not registered and are probably unaware that they are required to do so. FDA estimates that there are 37,000 facilities that have not yet registered.
In addition, S. 510 superimposes a significant regulatory burden on all of those facilities, regardless of the need from a food safety perspective. It is one thing to require a small-scale processor to register with the FDA; it is entirely different to require that small-scale processor to comply with extensive regulations on every step of its business. Small-scale producer and facilities that sell direct to consumers are inherently transparent and accountable and do not require federal oversight. Such facilities are already sufficiently regulated by state and local authorities.
QUESTION: Are direct marketing food processors exempt from the bill?
It depends. Based on FDAs guidance documents, food processors who market directly to individual consumers might be exempt from the requirements for HACCP-type programs. But the language is far from clear.
The bills provisions for facilities are dependent on the definition of facility under the 2002 Bioterrorism Act, which exempted retail food establishments from being categorized as facilities, but did not define the term. FDAs definition of the term does not address the majority of our local food producers. The specific examples of retail food establishments are establishments such as grocery stores, convenience stores, and vending machine locations. Not only are farmers markets, farm stands, and CSAs not listed, but they may not qualify because they typically sell food at a different physical location than where the food is held, packed, or processed. Consider the typical example of a small-scale processor who buys local ingredients and makes jams, breads, cheeses, etc. to sell at the farmers market. It may be that the farmers market itself qualifies as a "retail food establishment" -- but the commercial kitchen where the goods were prepared would not qualify, because the main purpose of that location is to process food, not sell to consumers. Different physical locations may mean different requirements under the FDAs definitions.
In addition, the current definitions specifically limit the exemption to producers who sell directly to individual consumers. It excludes producers who sell directly to end users such as restaurants, local grocers, and schools. So many food producers who provide healthy, safe foods to these institutions would be subject to the extensive new regulations under S.510.
The Tester Hagan amendment would do two things: (1) it would clarify that people selling directly to individual consumers are exempt, even if the physical location of the sale is different from the physical location of the processing; and (2) it would add a new exemption for processors who gross less than $500,000 and who sell directly to both individual consumers and other end-users such as local restaurants and local stores.
QUESTION: Does S. 510 help small farmers and local food producers?
No. The bill does include provisions to try to reduce the burdens that will be imposed on small producers, such as providing for longer deadlines for compliance and directing FDA to consider various issues facing organic farms and small businesses. But none of these actually prevent FDA from imposing new, burdensome requirements. The provisions essentially tell FDA to be nice to local food producers, but do not create enforceable limits on the agency's power.
IN SUMMARY: The Tester-Hagan amendment is a reasonable way to protect small-scale businesses from overly burdensome and unnecessary regulations, and thus also protect consumers options to buy from local producers whom they trust.
FOOD SAFETY LEGISLATION MOVING TOWARDS SENATE VOTE
The Senate has returned home without voting on S.510, the Food Safety Modernization Act, but unfortunately the bill is still alive. Before returning home, the Senate started the process to bring S.510 to the floor for a vote, and it is likely that they will finally vote on it shortly after they re-convene on November 15.
This bill greatly expands FDAs authority over both processed foods and fresh fruits and vegetables, and would give FDA authority to impose extensive, burdensome requirements on even the smallest processing facilities and farms who sell to local consumers.
We need the Tester-Hagan amendment to protect our vulnerable local businesses!
The Senators are back in their home States for the election season. This is an important time to publicize this issue and get their commitment to support the Tester-Hagan amendment!
ACTION TO TAKE
1) Contact your Senators local office. You can find your Senators contact information at www.Senate.gov . Call and ask them if the Senator will be attending any events near you, so that you can meet with them.
Urge your Senators to:
a)Support the Tester-Hagan amendment to exempt small-scale, local producers, AND
b)Oppose the addition of criminal penalties unless there is actual harm to human health
2)Educate your community by writing a letter to the editor. See the sample below
SAMPLE LETTER TO THE EDITOR
NOTE: It is VERY important to write your own, personal letter to the editor. Newspapers will NOT print form letters! The letter below is simply to provide you with some ideas. Remember to keep your letter short (100-150 words) and try to connect it with you, your family, and/or your community.
Dear Editor:
The U.S. Senate is likely to vote on a Food Safety bill (S. 510) when it reconvenes after the election. Unfortunately, as the bill is currently written, small local farms and processing facilities will come under a sweeping new industrial regulatory standard that threatens to put many of them out of the food business. These small producers provide food for our local community through CSAs, farmers markets, and local co-ops.
Sen. Jon Tester (MT), with Sen. Kay Hagan (NC), has an amendment to exempt small, direct-marketing farms and facilities. This amendment is critical to protecting local food systems and giving consumers a choice to buy fresh local products. It would be counter-productive and deeply disturbing if a bill designed to curb the abuses of Big Agribusiness snuffs out local food businesses as an "unintended consequence." Please call your Senators to urge them to vote for the Tester-Hagan amendment.
Signed,
Name
City, State
MORE INFORMATION
All of the well-publicized incidents of contamination in recent years including the recent egg recall occurred in industrialized food supply chains that span national and even international boundaries. The food safety problems in this system can and should be addressed without harming the local food systems that provide an alternative for consumers.
The growing trend toward healthy, fresh, locally sourced vegetables, fruit, dairy, and value-added products improves food safety by providing the opportunity for consumers to know their farmers and processors, to choose products on the basis of that relationship, and to readily trace any problems should they occur.
Farmers and processors who sell directly to consumers and end users have a direct relationship with their customers that ensures quality, safety, transparency and accountability. In addition, small-scale food producers are already regulated by local and state authorities, and the potential risk their products pose is inherently limited by their size. For these farmers and processors, new federal requirements are unnecessary and would simply harm both the food producers and their consumers.
Although S. 510 includes some provisions for flexibility for small and diversified producers and processors, the bills new hazard analysis and risk-based preventive controls would affect these facilities and authorize FDA to dictate growing and harvesting practices for produce. These requirements will impose significant expenses and burdens on individuals and small businesses.
Below are answers to some of the frequently asked questions.
QUESTION: What would S.510 do to farmers?
S.510 authorizes FDA to issue standards for production and harvesting of fruits and vegetables. Given the agencys track record, it is likely that the regulations will discriminate against small, organic, and diversified farms. While the bill directs FDA to consider the impact of its rulemaking on small-scale and diversified farms, there are few enforceable limits to protect small, sustainable farms from inappropriate and burdensome federal rules.
The only enforceable limit is that FDA's new regulations cannot contradict the regulations for certified organic producers. But many local food producers are not certified organic. And even certified organic can still be subject to additional regulations by FDA imposing impractical or unfair burdens, so long as the regulations dont directly contradict the organic regulations.
The Tester-Hagan amendment would exempt farms that have gross sales under $500,000 and that sell more than half of their produce directly to consumers and other qualified end users such as local restaurants and local stores.
QUESTION: Are direct marketing farms exempt from the bill?
No, direct-marketing farmers are not exempt from the produce safety standards. Under the bill as currently written, all farmers raising produce are subject to the produce safety standards (section 105 of the bill), regardless of how they market their fruits and vegetables.
The Tester-Hagan amendment is needed to protect direct marketing produce farmers from being told how to grow and harvest their crops by FDA bureaucrats.
QUESTION: What does S.510 require of people who process food?
Under S.510, anyone who processes food for sale would have to comply with extensive new regulations over every step of its process. This includes people who make such things as jam, bread, and cheese for local markets. S. 510 would require that all facilities would have to comply with a Hazard Analysis and Risk-Based Preventative Controls, which would require:
--Hazard analysis: Identify and evaluate known or reasonable hazards and develop written analysis of the hazards.
--Preventive Controls: Identify and implement preventive controls, to provide assurances that hazards indentified will be significantly minimized and prevented.
--Monitor effectiveness of the preventive controls.
--Establish procedures that a facility would implement if the preventive controls are found to be ineffective through monitoring.
--Verify that the preventive controls are adequate; that monitoring is in accordance with 103(d); that the owner is making appropriate decisions about corrective actions under 103(e); that the preventive controls are effectively and significantly minimizing or preventing the occurrence of identified hazards, including the use of environmental and product testing programs; that there is documented, periodic reanalysis of the plan to ensure that it is still relevant.
--Recordkeeping: Maintain, for not less than two years, records documenting the monitoring of the preventive controls implemented, instances of nonconformance, the results of testing, instances of corrective actions, and the efficacy of preventive controls.
--Written plan and documentation: Prepare a written plan that documents and describes the procedures used by the facility to comply with the requirements of this section, including analyzing the hazards under subsection 103(b) and identifying the preventive controls adopted under subsection 103(c) to address those hazards.
All of this would be subject to FDA approval, inspections, and fees for re-inspection. The paperwork burdens would drive many small-scale processors out of business.
The Tester-Hagan amendment would exempt processors that have gross sales under $500,000 and that sell more than half of their products directly to consumers and other qualified end users such as local restaurants and local stores. The amendment also exempts very small businesses, to be defined by FDA.
QUESTION: I heard that S.510 doesnt require anyone to register who isnt already required to do so. Is that true?
Technically, S.510 does not change the law on registration. But, in practical terms, there are thousands of small-scale processors who are not even aware that they have to register who will now be subject to extensive new requirements.
In 2002, Congress required all food facilities to register with the FDA under the Public Health Security and Bioterrrorism Preparedness and Bioterrorism Response Act of 2002. The rationale for such a sweeping federal reach into the smallest of food facilities was national security and bioterrorism.
While S.510 does not add new registration requirements, the reality is that there are many small-scale facilities that have not registered and are probably unaware that they are required to do so. FDA estimates that there are 37,000 facilities that have not yet registered.
In addition, S. 510 superimposes a significant regulatory burden on all of those facilities, regardless of the need from a food safety perspective. It is one thing to require a small-scale processor to register with the FDA; it is entirely different to require that small-scale processor to comply with extensive regulations on every step of its business. Small-scale producer and facilities that sell direct to consumers are inherently transparent and accountable and do not require federal oversight. Such facilities are already sufficiently regulated by state and local authorities.
QUESTION: Are direct marketing food processors exempt from the bill?
It depends. Based on FDAs guidance documents, food processors who market directly to individual consumers might be exempt from the requirements for HACCP-type programs. But the language is far from clear.
The bills provisions for facilities are dependent on the definition of facility under the 2002 Bioterrorism Act, which exempted retail food establishments from being categorized as facilities, but did not define the term. FDAs definition of the term does not address the majority of our local food producers. The specific examples of retail food establishments are establishments such as grocery stores, convenience stores, and vending machine locations. Not only are farmers markets, farm stands, and CSAs not listed, but they may not qualify because they typically sell food at a different physical location than where the food is held, packed, or processed. Consider the typical example of a small-scale processor who buys local ingredients and makes jams, breads, cheeses, etc. to sell at the farmers market. It may be that the farmers market itself qualifies as a "retail food establishment" -- but the commercial kitchen where the goods were prepared would not qualify, because the main purpose of that location is to process food, not sell to consumers. Different physical locations may mean different requirements under the FDAs definitions.
In addition, the current definitions specifically limit the exemption to producers who sell directly to individual consumers. It excludes producers who sell directly to end users such as restaurants, local grocers, and schools. So many food producers who provide healthy, safe foods to these institutions would be subject to the extensive new regulations under S.510.
The Tester Hagan amendment would do two things: (1) it would clarify that people selling directly to individual consumers are exempt, even if the physical location of the sale is different from the physical location of the processing; and (2) it would add a new exemption for processors who gross less than $500,000 and who sell directly to both individual consumers and other end-users such as local restaurants and local stores.
QUESTION: Does S. 510 help small farmers and local food producers?
No. The bill does include provisions to try to reduce the burdens that will be imposed on small producers, such as providing for longer deadlines for compliance and directing FDA to consider various issues facing organic farms and small businesses. But none of these actually prevent FDA from imposing new, burdensome requirements. The provisions essentially tell FDA to be nice to local food producers, but do not create enforceable limits on the agency's power.
IN SUMMARY: The Tester-Hagan amendment is a reasonable way to protect small-scale businesses from overly burdensome and unnecessary regulations, and thus also protect consumers options to buy from local producers whom they trust.
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