Federal Farming Power Grab Scheduled for Senate Vote Today

S.510, the Senate bill set to vastly expand federal power over agriculture, potentially choking off small local growers and hobby farmers, is set for a vote today.

Cloture, or a vote to end debate, on S.150 took place on Wednesday, November 17, with 74 votes for and 25 opposed. A final Manager's Amendment came into being after more than thirty hours of debate following cloture.

A Manager's Amendment is, quoting the C-SPAN Congressional Glossary, a package of numerous individual amendments agreed to by both sides in advance. The managers are the majority and the minority member who manage the debate on a bill for their side.

On Thursday, November 18, Tom Coburn (R-OK) held up the bill through design by asking for an amendment meant to address the subject of earmarks. A motion to proceed was voted on and passed.

Quoting Lee Bechtel, National Health Federation:

[D]uring the debate, Senator Harkin described some of the key points in the yet-to-be-voted-on Manager's Amendment. Among other changes, the final Manager's Amendment included an exemption for dietary supplements from Codex [1] food guidelines, exemption language for dietary supplement manufacturers and retailers from the conventional food company and distributor registration fees, reporting and product traceability requirements. The final Manager's Amendment also included the Tester-Hagan [2] amendment exempting small farmers and retailers; organic farmers were already exempted from FDA registration fee, reporting, and product traceability requirements, for farms with less than $500,000 in gross receipts. The compromise language was very close to the original Tester amendment, which is why Senators Tester and Hagan both voted in favor of moving the bill forward.

Friday, November 19, Majority Leader Harry Reid announced that agreement had been reached on the order of final amendments and votes on S.510, which are now scheduled for Monday, November 29, after the Thanksgiving recess. There will be a second cloture vote on the motion to proceed, followed by debate and votes on two amendments to be offered by Senator Coburn. These are to be followed by debate and a vote on the Manager's Amendment to the original S.510 bill. If successful, the vote on final bill passage follows.

As explained by Senator Harkin, he and Senators Reid and Durbin had worked out an agreement in advance of Senate passage with House Democratic leadership to accept the Senate-passed bill, hold it at the House desk, and then vote on passage of the Senate bill. This procedural maneuvering eliminates the usual joint Senate-House conference committee to work out differences with the Waxman- and House-passed Food Safety Bill, H.R.2749. If the House approves, the final version of the Senate Food Safety Bill would then be sent to President Obama for signing into new law.

Here's the nut of it: S.510 as originally envisioned by Dick Durbin (D-IL) has been moderated but not eliminated in the sense of preventing more big government. While no one in his right mind would argue against food safety, valid arguments can and have been raised against more government layered on top of the big government we already have. Amendments have been offered and appear to be in the final bill which seem to address the concerns of small businesses, small farmers, small ranchers, small food producers, farmers' markets, hobbyists, home gardeners, seed enthusiasts, and others.

The bill, as it stands now, is going to be available to be voted on after reconciliation with the House version (H.R.2749) with this proviso: no monies will be appropriated for this expanded authority in addition to the FDA's current $4-billion-plus budget. The suggestion that new fees imposed by these changes by the FDA will not begin to cover expansive new bureaucracies that would be enacted into law is correct. To carry out all of the new rules and FDA authorities, new spending will have to be approved, or current spending levels for other FDA programs or regulatory activities will have to be reduced. The beast can be starved in the future even if not defeated outright the first time around.

Now, a multi-part discussion is necessary to even scratch the surface of our national food supply and the safeguarding of that food supply, including defining terms from the Bill, such as National Agriculture and Food Defense Strategy. Imported foods, overseas processed food plants, all sorts of possible breakdowns in food safety have to be discussed.

Let's look at arguments for S.510 and its cccopanion HR 2749. The two sides of debate concerning these proposed sweeping laws can be roughly divided up into traditional and big business practices on one side and natural and small operations on the other.

From the Florida Organic Growers website, we learn they've urged passage of S.510 if -- I repeat, if -- the Tester-Hagan Amendment is included in the final bill. Quoting from their Statement:

The bill takes important steps to improve corporate food safety rules but it is not appropriate for small farms and processors that sell to restaurants, food coops, groceries, schools, wholesalers and at farm stands and farmers markets.

NSAC thinks that these farms should have food safety plans appropriate to their size and processing practices. But it is critical that as we ramp up food safety protections we don't inadvertently do harm to family farm value- added processing and the growing investments in local and regional food systems by imposing expensive, one-size-fits- all rules.

That's a provisional "Yes" from a substantial natural-market interest group.

From Growing Produce, there's a valuable discussion titled "Two Sides To Food Safety": "Despite the recent foodborne illness outbreak, legislators need to make sure food safety regulations take both large and small growers into consideration." This is not in favor of S.510, but it explains that there are two sides to the debate. The depth of market difficulties that have to be navigated by the men and women who just bring you leafy greens is hardly known to the average consumer, and it would be good if you read up on the Home - National Leafy Greens Marketing Agreement to start. Farming and ranching are tough businesses.

The industry trade group Food Marketing Institute urges swift passage of the Food Safety Modernization Act (FMI NEWS RELEASE). Marion Nestle of Food Politics urges passage of the bill, reasoning that whether you're large or small, if you produce food for sale, you need to be accountable to food safety laws and accountable to your buyers. No argument there. Michael Pollan, author of The Omnivore's Dilemma, argues that the bill should be passed though it is not perfect because we don't live in a perfect world (I don't think that puts words in his mouth). Read his interview with Ezra Klein of the Washington Post here.

GRIST presents a worthy and well-rounded list of pros and cons in its Food Fight debate.

And from Bill Marler, an attorney specializing in food safety and food-borne illnesses at the MarlerBlog, we read:

I am heading to DC early next week to attend with clients the House Energy and Commerce hearing on the latest in food safety theatre – the Egg Hearings (my bet is DeCoster “takes the 5th”). I also hope to be able to move forward the non-O157:H7 ball a bit more. However, I am still stunned that S. 510 will not move this session, and, given the likely results of the upcoming mid-term elections, will never see the light of day in my, or Linda's lifetime. As you might well recall, Linda Rivera is a Nevada woman who contracted E. coli from cookie dough and has been battling for her life for the past sixteen months, had been promised the Senate will move on the pending food safety bill, S. 510--the FDA Food Safety Modernization Act. A constituent of Senate Majority Leader Harry Reid (D-NV), Rivera and her family had also become key advocates for the bill that has languished in the Senate for months.

Obama Foodorama (yes, there actually is a website dedicated to Obama food initiatives) has an interesting take on the bill, referring to Senators Tester and Coburn as throwing monkey wrenches into this legislation. Read it for yourself.

Here's the curious thing: I've spent weeks scouring the internet for published reasons to support S.510. I suggest you do the same for five minutes. You won't find much. And you'd think for such a massive bill, there'd be arguments supporting it, but internet search engines won't be any help. There's almost no voice out there in support. That makes my nose itch.

One of the sources supporting the S.510 is the National Sustainable Agriculture Coalition (their article: National Sustainable Agriculture Coalition » Archive » Senate Food Safety Bill Includes Improvements That Support Farmers).

What was all the shouting about in my first article from Wednesday, November 17? There were quotes from respected sources alleging that with passage of S.510, we would lose our ability to grow our own gardens or save and trade seeds, that the bill would make farmers' markets into FDA police riots and create food police with their noses in everything. What was that all about? Because, demonstrably, there's not a single thing in the bill that says anything like that. Let us turn to an advocate of big government:

Do not examine legislation in the light of the benefits it will convey if properly administered, but in the light of the wrongs it would do and the harms it would cause if improperly administered.
 - Lyndon Johnson

Senator Tom Coburn, M.D. authored a comprehensive description of what's wrong with S.510. I see no reason to add to his exposition and have his permission to use it in full, with my highest possible recommendation. He published it on Tuesday, November 23 in USA Today.

Detailed Concerns with S.510, the FDA Food Safety Modernization Act of 2010

Growing an Already Disjointed and Duplicative Federal Government

In 2008, GAO testified before a House subcommittee that "FDA is one of 15 agencies that collectively administer at least 30 laws related to food safety. This fragmentation is the key reason GAO added the federal oversight of food safety to its High-Risk Series in January 2007 and called for a government wide reexamination of the food safety system. We have reported on problems with this system-including inconsistent oversight, ineffective coordination, and inefficient use of resources."

Specifically, GAO found that in 2003, FDA and USDA activities included overlapping and duplicative inspections of 1,451 domestic food-processing facilities that produce foods regulated by both agencies. This GAO testimony came on the heels of a 2005 GAO report that identified significant overlap in food safety activities conducted by USDA and the FDA, and to some extent the EPA and National Marine Fisheries Service (NMFS), including "71 interagency agreements [to coordinate overlapping activities] that the agencies entered into... However, the agencies have weak mechanisms for tracking these agreements that...lead to ineffective implementation."

This overlap was evident in the egg salmonella scare. The Wall Street Journal reported (USDA Graders Saw Bugs and Trash at Egg Producer; Didn't Tell FDA) that U.S. Department of Agriculture experts knew about sanitary problems at one of the two Iowa farms at the center of a massive nationwide egg recall, but did not notify health authorities.) USDA inspects farms and gives eggs their "Grade A" label, while the FDA technically is tasked with the safety of the final egg product.

This discrepancy was the impetus behind an egg safety rule originally promulgated 10 years ago by the FDA. Unfortunately, three administrations sat on the proposed rule without finalizing and implementing it. FDA Commissioner Dr. Hamburg stated, "We believe that had these rules been in place at an earlier time, it would have very likely enabled us to identify the problems on this farm before this kind of outbreak occurred." A lack of regulatory bill isn't the problem.

Charging the Bill to our Children and Grandchildren

The legislation will cost $1.4 billion over 5 years. This cost does not include an additional $230 million in expenditures that are directly offset by fees collected for those activities (re-inspections, mandatory recalls, etc.). The total cost of the bill is over $1.6 billion over 5 years. Of these costs, $335 million are for non-FDA programs - the food allergy grant program, implementation grants to assist producers, assistance grants to states and Indian Tribes.

Many argue that this spending is just "discretionary." It is important to realize that the CBO score reflects the cost of the increase in FDA's scope. It is true that this bill only authorizes funding (though problematically, for the first time ever provides an authorization line for just food activities at FDA).

If future appropriations do not add up to the amount CBO is estimating, the likely result is that none of these provisions can be fully implemented, or worse, the FDA is forced to cut corners in other areas it regulates (drugs/devices/etc.) to fund this added regulatory burden on foods.

Without paying for this bill, at best we are just passing it for a press release, and at worst, we shackle the FDA with unfunded mandates.

New and Unnecessary Non-FDA Spending

CBO estimates that implementing other provisions of S. 510 would increase non-FDA discretionary spending by $335 million over the 2011-2015 period. The bill would authorize three grant programs outside the purview of the FDA:

  • School-based allergy and anaphylaxis management grants. Authorized at $30 million annually, CBO estimates that this program would cost $107 million over the 2011-2015 period. This program creates new federal standards for how local schools deal with food allergies and ties the "voluntary" standards to eligibility for federal grant funds. This is not a federal role, the standards are overly prescriptive, and it duplicates existing efforts. The CDC has already published extensive best practices for how local schools can implement sounder strategies for dealing with food allergens. The word "food" is the only relationship between legislation to dictate the food allergy policies of local schools and legislation to modernize how the FDA regulates the food industry.
  • Food safety training, education, extension, outreach and technical assistance grants. Enacting the bill would require the Secretary of HHS to enter into cooperative agreements with the Secretary of Agriculture to provide grants for food safety training, education, extension, outreach, and technical assistance to owners and operators of farms, small food processors, and small fruit and vegetable merchant wholesalers. Based on spending patterns of similar programs, CBO estimates that implementing this provision would cost $21 million over the next five years
  • Food safety participation grants for states and Indian tribes. S. 510 would authorize the appropriation of $19.5 million for fiscal year 2010 and such sums in subsequent years to award grants to states and Indian tribes to expand participation in food safety efforts. CBO estimates that implementing this provision would cost $83 million over the 2011-2015 period.
Along with the grant programs, S. 510 also would require the Environmental Protection Agency (EPA) to participate in food safety activities and would require the Centers for Disease Control and Prevention (CDC) to enhance its participation in food safety activities. CBO estimates that EPA will incur costs of about $2 million annually. CDC is required to significantly increase its surveillance activities, which CBO estimates will cost $100 million over 5 years. CDC is also required to set up "Centers of Excellence" at selected state health departments to prepare for food outbreaks at a cost of $4 million annually.

Burdensome New Regulations

There are 225 pages of new regulations, many of which are problematic. While some regulations are potentially onerous, but perhaps reasonable - such as requiring every facility to have a scientifically-based, but very flexible, food safety plan-others give FDA sweeping authority with potentially significant consequences.

While it is hard to pull out just 1 or 2 regulations in the bill that make the entire thing unpalatable, on the whole this bill represents a weighty new regulatory structure on the food industry that will be particularly difficult for small producers and farms to comply with (with little evidence it will make food safer). The following regulations are perhaps the most troubling:

  • Performance standards. The bill gives the Secretary the authority to "issue contaminant-specific and science-based guidance documents, action levels, or regulations." The way the bill is written the authority is extremely broad and could be used by FDA to issue very specific and onerous regulations on food facilities, without even the normal rule-making and guidance process FDA food regulations normally go through.
  • Traceability. FDA is required to establish a "product tracing system within the FDA" based and develop additional record keeping requirements for foods determined to be "high risk." The House legislation includes "full pedigree" trace-back which puts FDA in charge of tracing the entire supply chain. The final bill requires the FDA to do this for high-risk foods, and while there are some limitations on FDA, anything further than the "one-up-one-back" requirement in the bioterrorism law will be very onerous on industry.
  • Standards for produce safety. For produce, this bill gives FDA the authority to create commodity-specific safety standards for produce. Instead of trusting industry and the free-market, this provision implies that complying with government standards is the best way to keep consumers safe. A lot of the produce industry lobbied for these standards to provide "consumer confidence" after the jalapeno and tomato scare, but federal regulations could particularly adversely impact small providers.
Other regulations in this bill are overly punitive and could set up an adverse relationship with industry. They include:

  • Administrative Detention of Food. The bill lowers the threshold for detaining articles of food to "adulterated or misbranded." The threshold is currently higher for a reason-administrative detention is an authority that should only be used when there is clear, imminent danger.
  • Suspension of Registration. Facility registration may be suspended if there is a reasonable probability that food from the responsible facility will cause serious adverse health consequences or death to humans or animals. "Reasonable probability" isn't a difficult enough burden for FDA to prove when the consequence is closing down a private business.
  • Fees. Allows FDA to assess fees for compliance failures (recalls and re-inspections). These fees give FDA incentive to find reasons to re-inspect a facility or order a mandatory recall-the only ways they can collect money for their efforts. Furthermore, assessing industry to pay for a new regulatory structure will increase food costs for consumers during a recession.
  • Mandatory Recall Authority. Provides FDA with the authority to force a recall (and collect fees to pay for it). It is unclear why this authority is necessary - even in the worst food safety outbreaks, there do not appear to be any instances in which tainted products were on the shelves or with distributors that the company at fault did not work with FDA to conduct a voluntary recall. Allowing FDA to collect fees for forcing a mandatory recall could also push FDA to pull the trigger early on a mandatory recall - putting them at odds with the company responsible.

Taking off from Lyndon Johnson's observation, quoted above, the ambiguity of language in S.510 provides a giant opportunity for empowered authorities to make up both the intent and meaning of these proposed regulations and interpret this law as they see fit when they should be constrained by specifics. Legislators can be amazingly specific when they want to be. But a law that is couched in terms and phrases open to interpretation is exactly what leads to cascading unintended consequences. And many believe that's exactly why ambiguous language is used. Along the lines of "better to ask forgiveness than permission." Or, more bluntly, we'll do as we please, see you in court, and we'll let a judge sort it out.

This is exactly why so much distress and anger permeates the internet over S.510: the possibility of slowly eroding the natural rights of home gardeners and their valued seed stocks in the face of the sweeping changes genetically patented seed lines represent. Attorneys for multinational corporations making these GMO seeds are ruthless in pursuing lawsuits to enforce what they claim is patent infringement -- even when it is nature spreading these seeds into fields and farms, and not by consent or intent of farmers who find GMO patented seeds suddenly among their crops. The what if scenarios of ambiguous language coupled to a corporatist-Statist administration are frightening, and the people raising an alarm about home gardens and seed stocks are probably not Chicken Littles. Not if recent history is any indication.

It's sophomorically easy and disingenuous to arm-chair quarterback. The safety of our food supply and the responsibility for overseeing what that requires is a gargantuan undertaking. Hats off to every one in the chain of command who is doing the job right, efficiently, and without bureaucratic malice. But arming that chain of command with vastly enlarged responsibilities riddled with powers of enforcement ambiguous at best is to ensure a law that harms rather than protects. Man is a fickle animal capable of glory and honor, but he is just as capable of chicanery and greed. Ambiguity invites disaster.

Lastly, S.510 is an inverted pyramid of power. Growing federal mandates on top of an already top-heavy bureaucratic leviathan is neither efficient nor safe. Going to the well again, let's say it over and over: complexity is the enemy of security.

As sweeping a bill as has ever been introduced regarding food safety, S.510 reaches too far and too wide and embraces too much with a one-size-fits-all worldview. Instead of the hard work of focusing on specific issues and making those work within the structure of laws and regulations and departments already empowered, the authors of S.510 chose to use the biggest brush on the biggest canvas.

...Resulting in an embodiment of the truism complexity is the enemy of security.

Dump S.510, go back to the drawing board, leverage the brilliance of the free market, and reinstitute simplicity for the sake of security.

Michael Geer invites comments at geer.michael@gmail.com

[1] Codex Alimentarius Codex Alimentarius - Wikipedia, the free encyclopedia -- make sure you read the Controversy section; then do further research on why the United States Congress considers any legislation which advances United Nations' goals regarding our self-determined and independent preferences of foods, supplements, vitamins, and other nutritional choices.

[2] Senator John Tester (D-MT) is a Certified organic farmer. T-Bones farm is 1,400 acres and a diverse organic operation.
S.510, the Senate bill set to vastly expand federal power over agriculture, potentially choking off small local growers and hobby farmers, is set for a vote today.

Cloture, or a vote to end debate, on S.150 took place on Wednesday, November 17, with 74 votes for and 25 opposed. A final Manager's Amendment came into being after more than thirty hours of debate following cloture.

A Manager's Amendment is, quoting the C-SPAN Congressional Glossary, a package of numerous individual amendments agreed to by both sides in advance. The managers are the majority and the minority member who manage the debate on a bill for their side.

On Thursday, November 18, Tom Coburn (R-OK) held up the bill through design by asking for an amendment meant to address the subject of earmarks. A motion to proceed was voted on and passed.

Quoting Lee Bechtel, National Health Federation:

[D]uring the debate, Senator Harkin described some of the key points in the yet-to-be-voted-on Manager's Amendment. Among other changes, the final Manager's Amendment included an exemption for dietary supplements from Codex [1] food guidelines, exemption language for dietary supplement manufacturers and retailers from the conventional food company and distributor registration fees, reporting and product traceability requirements. The final Manager's Amendment also included the Tester-Hagan [2] amendment exempting small farmers and retailers; organic farmers were already exempted from FDA registration fee, reporting, and product traceability requirements, for farms with less than $500,000 in gross receipts. The compromise language was very close to the original Tester amendment, which is why Senators Tester and Hagan both voted in favor of moving the bill forward.

Friday, November 19, Majority Leader Harry Reid announced that agreement had been reached on the order of final amendments and votes on S.510, which are now scheduled for Monday, November 29, after the Thanksgiving recess. There will be a second cloture vote on the motion to proceed, followed by debate and votes on two amendments to be offered by Senator Coburn. These are to be followed by debate and a vote on the Manager's Amendment to the original S.510 bill. If successful, the vote on final bill passage follows.

As explained by Senator Harkin, he and Senators Reid and Durbin had worked out an agreement in advance of Senate passage with House Democratic leadership to accept the Senate-passed bill, hold it at the House desk, and then vote on passage of the Senate bill. This procedural maneuvering eliminates the usual joint Senate-House conference committee to work out differences with the Waxman- and House-passed Food Safety Bill, H.R.2749. If the House approves, the final version of the Senate Food Safety Bill would then be sent to President Obama for signing into new law.

Here's the nut of it: S.510 as originally envisioned by Dick Durbin (D-IL) has been moderated but not eliminated in the sense of preventing more big government. While no one in his right mind would argue against food safety, valid arguments can and have been raised against more government layered on top of the big government we already have. Amendments have been offered and appear to be in the final bill which seem to address the concerns of small businesses, small farmers, small ranchers, small food producers, farmers' markets, hobbyists, home gardeners, seed enthusiasts, and others.

The bill, as it stands now, is going to be available to be voted on after reconciliation with the House version (H.R.2749) with this proviso: no monies will be appropriated for this expanded authority in addition to the FDA's current $4-billion-plus budget. The suggestion that new fees imposed by these changes by the FDA will not begin to cover expansive new bureaucracies that would be enacted into law is correct. To carry out all of the new rules and FDA authorities, new spending will have to be approved, or current spending levels for other FDA programs or regulatory activities will have to be reduced. The beast can be starved in the future even if not defeated outright the first time around.

Now, a multi-part discussion is necessary to even scratch the surface of our national food supply and the safeguarding of that food supply, including defining terms from the Bill, such as National Agriculture and Food Defense Strategy. Imported foods, overseas processed food plants, all sorts of possible breakdowns in food safety have to be discussed.

Let's look at arguments for S.510 and its cccopanion HR 2749. The two sides of debate concerning these proposed sweeping laws can be roughly divided up into traditional and big business practices on one side and natural and small operations on the other.

From the Florida Organic Growers website, we learn they've urged passage of S.510 if -- I repeat, if -- the Tester-Hagan Amendment is included in the final bill. Quoting from their Statement:

The bill takes important steps to improve corporate food safety rules but it is not appropriate for small farms and processors that sell to restaurants, food coops, groceries, schools, wholesalers and at farm stands and farmers markets.

NSAC thinks that these farms should have food safety plans appropriate to their size and processing practices. But it is critical that as we ramp up food safety protections we don't inadvertently do harm to family farm value- added processing and the growing investments in local and regional food systems by imposing expensive, one-size-fits- all rules.

That's a provisional "Yes" from a substantial natural-market interest group.

From Growing Produce, there's a valuable discussion titled "Two Sides To Food Safety": "Despite the recent foodborne illness outbreak, legislators need to make sure food safety regulations take both large and small growers into consideration." This is not in favor of S.510, but it explains that there are two sides to the debate. The depth of market difficulties that have to be navigated by the men and women who just bring you leafy greens is hardly known to the average consumer, and it would be good if you read up on the Home - National Leafy Greens Marketing Agreement to start. Farming and ranching are tough businesses.

The industry trade group Food Marketing Institute urges swift passage of the Food Safety Modernization Act (FMI NEWS RELEASE). Marion Nestle of Food Politics urges passage of the bill, reasoning that whether you're large or small, if you produce food for sale, you need to be accountable to food safety laws and accountable to your buyers. No argument there. Michael Pollan, author of The Omnivore's Dilemma, argues that the bill should be passed though it is not perfect because we don't live in a perfect world (I don't think that puts words in his mouth). Read his interview with Ezra Klein of the Washington Post here.

GRIST presents a worthy and well-rounded list of pros and cons in its Food Fight debate.

And from Bill Marler, an attorney specializing in food safety and food-borne illnesses at the MarlerBlog, we read:

I am heading to DC early next week to attend with clients the House Energy and Commerce hearing on the latest in food safety theatre – the Egg Hearings (my bet is DeCoster “takes the 5th”). I also hope to be able to move forward the non-O157:H7 ball a bit more. However, I am still stunned that S. 510 will not move this session, and, given the likely results of the upcoming mid-term elections, will never see the light of day in my, or Linda's lifetime. As you might well recall, Linda Rivera is a Nevada woman who contracted E. coli from cookie dough and has been battling for her life for the past sixteen months, had been promised the Senate will move on the pending food safety bill, S. 510--the FDA Food Safety Modernization Act. A constituent of Senate Majority Leader Harry Reid (D-NV), Rivera and her family had also become key advocates for the bill that has languished in the Senate for months.

Obama Foodorama (yes, there actually is a website dedicated to Obama food initiatives) has an interesting take on the bill, referring to Senators Tester and Coburn as throwing monkey wrenches into this legislation. Read it for yourself.

Here's the curious thing: I've spent weeks scouring the internet for published reasons to support S.510. I suggest you do the same for five minutes. You won't find much. And you'd think for such a massive bill, there'd be arguments supporting it, but internet search engines won't be any help. There's almost no voice out there in support. That makes my nose itch.

One of the sources supporting the S.510 is the National Sustainable Agriculture Coalition (their article: National Sustainable Agriculture Coalition » Archive » Senate Food Safety Bill Includes Improvements That Support Farmers).

What was all the shouting about in my first article from Wednesday, November 17? There were quotes from respected sources alleging that with passage of S.510, we would lose our ability to grow our own gardens or save and trade seeds, that the bill would make farmers' markets into FDA police riots and create food police with their noses in everything. What was that all about? Because, demonstrably, there's not a single thing in the bill that says anything like that. Let us turn to an advocate of big government:

Do not examine legislation in the light of the benefits it will convey if properly administered, but in the light of the wrongs it would do and the harms it would cause if improperly administered.
 - Lyndon Johnson

Senator Tom Coburn, M.D. authored a comprehensive description of what's wrong with S.510. I see no reason to add to his exposition and have his permission to use it in full, with my highest possible recommendation. He published it on Tuesday, November 23 in USA Today.

Detailed Concerns with S.510, the FDA Food Safety Modernization Act of 2010

Growing an Already Disjointed and Duplicative Federal Government

In 2008, GAO testified before a House subcommittee that "FDA is one of 15 agencies that collectively administer at least 30 laws related to food safety. This fragmentation is the key reason GAO added the federal oversight of food safety to its High-Risk Series in January 2007 and called for a government wide reexamination of the food safety system. We have reported on problems with this system-including inconsistent oversight, ineffective coordination, and inefficient use of resources."

Specifically, GAO found that in 2003, FDA and USDA activities included overlapping and duplicative inspections of 1,451 domestic food-processing facilities that produce foods regulated by both agencies. This GAO testimony came on the heels of a 2005 GAO report that identified significant overlap in food safety activities conducted by USDA and the FDA, and to some extent the EPA and National Marine Fisheries Service (NMFS), including "71 interagency agreements [to coordinate overlapping activities] that the agencies entered into... However, the agencies have weak mechanisms for tracking these agreements that...lead to ineffective implementation."

This overlap was evident in the egg salmonella scare. The Wall Street Journal reported (USDA Graders Saw Bugs and Trash at Egg Producer; Didn't Tell FDA) that U.S. Department of Agriculture experts knew about sanitary problems at one of the two Iowa farms at the center of a massive nationwide egg recall, but did not notify health authorities.) USDA inspects farms and gives eggs their "Grade A" label, while the FDA technically is tasked with the safety of the final egg product.

This discrepancy was the impetus behind an egg safety rule originally promulgated 10 years ago by the FDA. Unfortunately, three administrations sat on the proposed rule without finalizing and implementing it. FDA Commissioner Dr. Hamburg stated, "We believe that had these rules been in place at an earlier time, it would have very likely enabled us to identify the problems on this farm before this kind of outbreak occurred." A lack of regulatory bill isn't the problem.

Charging the Bill to our Children and Grandchildren

The legislation will cost $1.4 billion over 5 years. This cost does not include an additional $230 million in expenditures that are directly offset by fees collected for those activities (re-inspections, mandatory recalls, etc.). The total cost of the bill is over $1.6 billion over 5 years. Of these costs, $335 million are for non-FDA programs - the food allergy grant program, implementation grants to assist producers, assistance grants to states and Indian Tribes.

Many argue that this spending is just "discretionary." It is important to realize that the CBO score reflects the cost of the increase in FDA's scope. It is true that this bill only authorizes funding (though problematically, for the first time ever provides an authorization line for just food activities at FDA).

If future appropriations do not add up to the amount CBO is estimating, the likely result is that none of these provisions can be fully implemented, or worse, the FDA is forced to cut corners in other areas it regulates (drugs/devices/etc.) to fund this added regulatory burden on foods.

Without paying for this bill, at best we are just passing it for a press release, and at worst, we shackle the FDA with unfunded mandates.

New and Unnecessary Non-FDA Spending

CBO estimates that implementing other provisions of S. 510 would increase non-FDA discretionary spending by $335 million over the 2011-2015 period. The bill would authorize three grant programs outside the purview of the FDA:

  • School-based allergy and anaphylaxis management grants. Authorized at $30 million annually, CBO estimates that this program would cost $107 million over the 2011-2015 period. This program creates new federal standards for how local schools deal with food allergies and ties the "voluntary" standards to eligibility for federal grant funds. This is not a federal role, the standards are overly prescriptive, and it duplicates existing efforts. The CDC has already published extensive best practices for how local schools can implement sounder strategies for dealing with food allergens. The word "food" is the only relationship between legislation to dictate the food allergy policies of local schools and legislation to modernize how the FDA regulates the food industry.
  • Food safety training, education, extension, outreach and technical assistance grants. Enacting the bill would require the Secretary of HHS to enter into cooperative agreements with the Secretary of Agriculture to provide grants for food safety training, education, extension, outreach, and technical assistance to owners and operators of farms, small food processors, and small fruit and vegetable merchant wholesalers. Based on spending patterns of similar programs, CBO estimates that implementing this provision would cost $21 million over the next five years
  • Food safety participation grants for states and Indian tribes. S. 510 would authorize the appropriation of $19.5 million for fiscal year 2010 and such sums in subsequent years to award grants to states and Indian tribes to expand participation in food safety efforts. CBO estimates that implementing this provision would cost $83 million over the 2011-2015 period.
Along with the grant programs, S. 510 also would require the Environmental Protection Agency (EPA) to participate in food safety activities and would require the Centers for Disease Control and Prevention (CDC) to enhance its participation in food safety activities. CBO estimates that EPA will incur costs of about $2 million annually. CDC is required to significantly increase its surveillance activities, which CBO estimates will cost $100 million over 5 years. CDC is also required to set up "Centers of Excellence" at selected state health departments to prepare for food outbreaks at a cost of $4 million annually.

Burdensome New Regulations

There are 225 pages of new regulations, many of which are problematic. While some regulations are potentially onerous, but perhaps reasonable - such as requiring every facility to have a scientifically-based, but very flexible, food safety plan-others give FDA sweeping authority with potentially significant consequences.

While it is hard to pull out just 1 or 2 regulations in the bill that make the entire thing unpalatable, on the whole this bill represents a weighty new regulatory structure on the food industry that will be particularly difficult for small producers and farms to comply with (with little evidence it will make food safer). The following regulations are perhaps the most troubling:

  • Performance standards. The bill gives the Secretary the authority to "issue contaminant-specific and science-based guidance documents, action levels, or regulations." The way the bill is written the authority is extremely broad and could be used by FDA to issue very specific and onerous regulations on food facilities, without even the normal rule-making and guidance process FDA food regulations normally go through.
  • Traceability. FDA is required to establish a "product tracing system within the FDA" based and develop additional record keeping requirements for foods determined to be "high risk." The House legislation includes "full pedigree" trace-back which puts FDA in charge of tracing the entire supply chain. The final bill requires the FDA to do this for high-risk foods, and while there are some limitations on FDA, anything further than the "one-up-one-back" requirement in the bioterrorism law will be very onerous on industry.
  • Standards for produce safety. For produce, this bill gives FDA the authority to create commodity-specific safety standards for produce. Instead of trusting industry and the free-market, this provision implies that complying with government standards is the best way to keep consumers safe. A lot of the produce industry lobbied for these standards to provide "consumer confidence" after the jalapeno and tomato scare, but federal regulations could particularly adversely impact small providers.
Other regulations in this bill are overly punitive and could set up an adverse relationship with industry. They include:

  • Administrative Detention of Food. The bill lowers the threshold for detaining articles of food to "adulterated or misbranded." The threshold is currently higher for a reason-administrative detention is an authority that should only be used when there is clear, imminent danger.
  • Suspension of Registration. Facility registration may be suspended if there is a reasonable probability that food from the responsible facility will cause serious adverse health consequences or death to humans or animals. "Reasonable probability" isn't a difficult enough burden for FDA to prove when the consequence is closing down a private business.
  • Fees. Allows FDA to assess fees for compliance failures (recalls and re-inspections). These fees give FDA incentive to find reasons to re-inspect a facility or order a mandatory recall-the only ways they can collect money for their efforts. Furthermore, assessing industry to pay for a new regulatory structure will increase food costs for consumers during a recession.
  • Mandatory Recall Authority. Provides FDA with the authority to force a recall (and collect fees to pay for it). It is unclear why this authority is necessary - even in the worst food safety outbreaks, there do not appear to be any instances in which tainted products were on the shelves or with distributors that the company at fault did not work with FDA to conduct a voluntary recall. Allowing FDA to collect fees for forcing a mandatory recall could also push FDA to pull the trigger early on a mandatory recall - putting them at odds with the company responsible.

Taking off from Lyndon Johnson's observation, quoted above, the ambiguity of language in S.510 provides a giant opportunity for empowered authorities to make up both the intent and meaning of these proposed regulations and interpret this law as they see fit when they should be constrained by specifics. Legislators can be amazingly specific when they want to be. But a law that is couched in terms and phrases open to interpretation is exactly what leads to cascading unintended consequences. And many believe that's exactly why ambiguous language is used. Along the lines of "better to ask forgiveness than permission." Or, more bluntly, we'll do as we please, see you in court, and we'll let a judge sort it out.

This is exactly why so much distress and anger permeates the internet over S.510: the possibility of slowly eroding the natural rights of home gardeners and their valued seed stocks in the face of the sweeping changes genetically patented seed lines represent. Attorneys for multinational corporations making these GMO seeds are ruthless in pursuing lawsuits to enforce what they claim is patent infringement -- even when it is nature spreading these seeds into fields and farms, and not by consent or intent of farmers who find GMO patented seeds suddenly among their crops. The what if scenarios of ambiguous language coupled to a corporatist-Statist administration are frightening, and the people raising an alarm about home gardens and seed stocks are probably not Chicken Littles. Not if recent history is any indication.

It's sophomorically easy and disingenuous to arm-chair quarterback. The safety of our food supply and the responsibility for overseeing what that requires is a gargantuan undertaking. Hats off to every one in the chain of command who is doing the job right, efficiently, and without bureaucratic malice. But arming that chain of command with vastly enlarged responsibilities riddled with powers of enforcement ambiguous at best is to ensure a law that harms rather than protects. Man is a fickle animal capable of glory and honor, but he is just as capable of chicanery and greed. Ambiguity invites disaster.

Lastly, S.510 is an inverted pyramid of power. Growing federal mandates on top of an already top-heavy bureaucratic leviathan is neither efficient nor safe. Going to the well again, let's say it over and over: complexity is the enemy of security.

As sweeping a bill as has ever been introduced regarding food safety, S.510 reaches too far and too wide and embraces too much with a one-size-fits-all worldview. Instead of the hard work of focusing on specific issues and making those work within the structure of laws and regulations and departments already empowered, the authors of S.510 chose to use the biggest brush on the biggest canvas.

...Resulting in an embodiment of the truism complexity is the enemy of security.

Dump S.510, go back to the drawing board, leverage the brilliance of the free market, and reinstitute simplicity for the sake of security.

Michael Geer invites comments at geer.michael@gmail.com

[1] Codex Alimentarius Codex Alimentarius - Wikipedia, the free encyclopedia -- make sure you read the Controversy section; then do further research on why the United States Congress considers any legislation which advances United Nations' goals regarding our self-determined and independent preferences of foods, supplements, vitamins, and other nutritional choices.

[2] Senator John Tester (D-MT) is a Certified organic farmer. T-Bones farm is 1,400 acres and a diverse organic operation.

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