Archive for July, 2011

Friday, July 29, 2011 @ 05:07 PM
posted by Mik and Rudi

Comment Submission:  Proposed Rulemaking on Federal Leafy Green Vegetable Marketing RegsReference Docket Number: [Doc. No. AO–FV–09–0138; AMS–FV–09–0029; FV09–970–1]

The POP Campaign (Preserve Organic Power), a voice of hundreds of thousands of consumers and families across this country, adamantly opposes the USDA’s proposed rulemaking to create a Federal Leafy Green Vegetable Marketing Regulation.  This rulemaking is neither needed nor desired.  The Federal government has in recent years enacted so many new laws to promote food safety, which in addition to the regulations that are already in place both at the Federal and State level, are sufficient to promote safer foods and processes.  Another layer simply does not make common sense nor is it cost effective; rather cost prohibitive. During these economic times, families in particular are being hit hard – and families are the basic fabric of a healthy America – we support regulations that help these families, not hinder their stability and foundational health.

Other Regulations Already Exist

State Regulations: As stated by the USDA, 90% or more of the leafy green vegetables grown in the United States are gown in California and Arizona both of whom have Leafy Green Marketing Agreements in place.  There is no need to implement yet another federal standard on the small farmers across the other 48 states.  Additionally, most producers of leafy green vegetables in the other states likely sell their products locally or intra-state to a neighboring state.

For farmers in California and Arizona, this new Federal agreement would provide an unreasonable additional layer of bureaucracy and costs, which will only drive the costs of leafy green vegetables higher.  As a Californian, I personally do not want this added burden. Americans, especially moms with families who we hear from, are already bearing the burden of substantially higher food costs during a time with high unemployment rates, skyrocketing fuel costs, and higher costs of living across the board.  This is not a time to bleed these families.

Federal Guidelines Already Exist

The US Food and Drug Administration (FDA) already has in place two guidelines and is in the final stages of a leafy green specific guideline.  These guidelines, listed below are sufficient instruction at the Federal level.

The FDA currently has Good Agricultural Practice Guidelines including

  1. ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables’’(1998), and the
  2. ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh-cut Fruits and Vegetables’’ (2008).
  3. A new FDA Guideline entitled, ‘‘Commodity Specific Food Safety Guidelines for Lettuce and Leafy Greens Supply Chain’’ is in the process of being finalized.

Furthermore, the FDA has a mandatory Good Manufacturing Practices (GMPs) regulation for manufacturers of fresh-cut leafy green vegetables.

Cost for Participation Presents an Undue Burden

As mentioned above, there are substantial costs associated with implementing this program.  These costs pose an unreasonable burden for both the farmer and the consumer, especially moms in this country.

  • The USDA estimates that the cost per acre to become initially compliant will be $14-34 per acre.
  • The USDA published two estimates for the annual cost of compliance:
    • $30-50 per acre
    • $48-105 per acre
    • Additionally, in California and Arizona, there would be additional costs for complying with the state marketing agreements. (This means even higher costs at the markets.)
    • Most small farms that produce leafy green vegetables also qualify as ‘handlers’ because they often market their products directly to consumer or to local markets.  The USDA provided that evidence shows that a small handler who is also a small producer would have audit verification or compliance related costs ranging from $67 to $95 per acre.  (For example, a 500 acre farm might incur greater than $45,000 up front and an additional $50,000 annually to become compliant. Most small farms likely cannot bear this burden and the higher costs will make them less competitive in the marketplace.)

Additionally, the fees required in the program will not cover the entire cost of managing this program. Guess what –the taxpayer and families will bear additional costs annually in the USDA budget and the consumer trickle down.

Organic Farms Are Already Heavy Regulated – make an exception

As provided by the USDA[1]:  An increasing number of U.S. farmers are adopting these systems in order to lower input costs, conserve nonrenewable resources, capture high-value markets, and boost farm income. The Organic Foods Production Act of 1990 already facilitates domestic marketing of organically produced fresh and processed food, and assures consumers that such products meet consistent, uniform standards. USDA’s Agricultural Marketing Service (AMS) finalized a rule to implement this legislation in 2002.  All but the smallest organic farmers and processors must be certified by a State or private agency accreditation under national standards. The program establishes:

  • National production and handling standards for organically produced products, including a National List of substances that can and cannot be used.
  • A national-level accreditation program for State and private organizations who must be accredited as certifying agents under the USDA national standards for organic certifiers.
  • Requirements for labeling products as organic and containing organic ingredients.
  • Rules for importation of organic agricultural products from foreign programs.

One possibility is to exempt organic farmers and small growers

Driving the Costs Up Will Reduce Access

The Fresh Fruits and Vegetables Program of the USDA which Senator Tom Harkin has been a big supporter of, is the type of activity USDA should focus on, not the creation of a new monitoring program.  The Fresh Fruits and Vegetable Program funds the delivery of fresh fruits and vegetables to children in schools, especially to low-income children who might not otherwise have the opportunity to consume fresh produce.  Driving the costs higher only undermines this program and the goals of families everywhere who are struggling to stay afloat in these challenging times and still provide their families with fresh produce including leafy green vegetables.

Food prices across the board are skyrocketing, and vegetables are among the foods that have risen the greatest, up 50% from a year ago. Conservatively, 68% of women in this country cite that the financial strain of the economy is threatening the American family; 52% of women with children under the age of 18 are feeling a huge overwhelm by financial burdens. Moms are saying “stop; help us”.

The POP Campaign strongly urges the USDA to terminate this proposed program and focus instead on promoting organic, sustainable farmers and farming which will provide higher quality foods for the American consumer, especially economically burdened moms and families.


[1] http://www.ers.usda.gov/features/organic/organicfarming.htm

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Tuesday, July 26, 2011 @ 05:07 PM
posted by admin

USDA Moves Forward with Proposed Rulemaking on Federal

Leafy Green Vegetable Marketing Regulation

July 2011:  Deadline fast approaching to Submit Comments (July 28)

Comments in Support or Opposition to Proposed Marketing Agreement No. 970:  (Leafy Green Vegetables) should be filed with

Hearing Clerk

United States Department of Agriculture

1400 Independence Ave., SW., Room 1031–S

Washington, DC 20250–9200

Fax: (202) 720–9776

Or via the Internet at http://www.regulations.gov.

Reference Docket Number: [Doc. No. AO–FV–09–0138; AMS–FV–09–0029; FV09–970–1]

Background: A September 2006 food borne illness incidence involving leafy green vegetables (spinach) resulted in a massive recall of spinach for fear of Escherichia coli (E. coli) contamination. Subsequently in 2007, members of the California leafy green vegetable industry initiated the establishment of a State marketing agreement for handlers of leafy green vegetables in which 99 percent of leafy green vegetables were covered.  In October 2007, Arizona enacted regulations which covered 75% of their leafy green production.  According to the USDA, participation in both the California and Arizona programs are voluntary, however; the requirements of these State marketing agreements are mandatory for all signatories within each respective State.

In June 2009, the following organizations petitioned the Agricultural Marketing Service division of the USDA requested the agency launch a federal rulemaking:

  • United Fresh Produce Association,
  • Produce Marketing
  • Association,
  • Georgia Fresh Vegetable
  • Association,
  • Georgia Farm Bureau,
  • Texas Vegetable Association,
  • Arizona
  • Farm Bureau, Leafy Greens Council,
  • California Farm Bureau,
  • California Leafy
  • Greens Products Handler Marketing Agreement,
  • Grower-Shipper Association of Central California,
  • Western Growers, and
  • The Imperial Valley Vegetable Growers Association.

These groups proposed “the establishment of a program that would oversee a systematic application of good agricultural production, handling, and manufacturing practices for leafy green vegetables. Proponents stated that the proposed agreement would minimize

the potential for microbial contamination in production and handling systems and would improve consumer confidence in leafy green vegetables in the United States market.”

The suggested program would:

  • Have voluntary participation
  • If company signs agreement would have mandatory compliance
  • Administered by USDA with Industry Comprised Administrative Board
  • Add two advisory bodies to (1) identification and development of audit
  • Metrics and (2) to advise the administrative body on research and development projects administered under the program
  • Financed primarily by fees assessed to signatory members based on their production
  • Secondary financing through contributions for research
  • Audit metrics would require USDA approval prior to implementation
  • It was suggested that audits be conducted by USDA  Inspection Service or “or persons or organizations authorized to audit on its behalf”

The USDA in their rulemaking acknowledges that a number of organizations opposed the development of this marketing agreement.  They include:

  • the National Organic Coalition (NOC)
  • Beyond Pesticides
  • Center for Food Safety
  • Equal Exchange
  • Food and Water Watch
  • Maine Organic Farmers and Gardeners Association
  • Midwest Organic Farmers and Gardeners Association
  • National Cooperative Grocers Association
  • Northeast Organic Dairy Producers Alliance,
  • Northeast Organic Farming Association-Interstate Council
  • Organically Grown Company
  • Rural Advancement Foundation International-USA
  • the Union of Concerned Scientists

Reasons for opposition by many included:

  • Costs associated with becoming compliant
  • The existing proliferation of audit requirements from private sector customers
  • The addition of a new and potentially conflicting set of audit requirements, and
  • ‘‘Audit Fatigue’’
  • The need for science-based production and handling requirements need for adequate peer-review of scientific studies used to establish them
  • Potential conflicts between existing Federal, State, and local conservation wildlife, and environmental regulations and any proposed metrics
  • The need for recognition of organic and other nonconventional production and handling practices in the development of audit metrics;
  • The appropriateness and authority for USDA oversight of the proposed agreement; and,
  • Whether there was the need for a national program

90 % of Production Already Covered by State Agreements

The USDA acknowledges that while there is leafy green vegetable production in every state, that 75% of all leafy green vegetables sold in the United States are produced in California and that 15% are produced in Arizona.  (Both states already have Leafy Green Marketing Agreements in place.) The remaining 10% is spread throughout the other 48 states and typically comes from small to medium size farms.

Other Regulations Already Exist

The FDA currently has Good Agricultural Practice Guidelines including

  1. ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables’’(1998), and the
  2. ‘‘Guide to Minimize Microbial Food Safety Hazards for Fresh-cut Fruits and Vegetables’’ (2008).
  3. A new FDA Guideline entitled, ‘‘Commodity Specific Food Safety Guidelines for Lettuce and Leafy Greens Supply Chain’’ is in the process of being finalized.

Furthermore, the FDA has a mandatory Good Manufacturing Practices (GMPs) regulation for manufacturers of fresh-cut leafy green vegetables.

The AMS of the USDA, in partnership with State departments of agriculture, offers a voluntary, audit-based program that verifies adherence to the two FDA guidelines that are final above (and conceivable when the new FDA guidelines identified above will offer audits)

Cost for Participation is High

  • The USDA estimates that the cost per acre to become initially compliant will be $14-34 per acre.  The USDA published two estimates for the annual cost of compliance:
    • $30-50 per acre
    • $48-105 per acre
    • Additionally, in California and Arizona, there would be additional costs for complying with the state marketing agreements.
    • Most small farms that produce leafy green vegetables also qualify as ‘handlers’ because they often market their products directly to consumer or to local markets.  The USDA provided that evidence shows that a small handler who is also a small producer would have audit verification or compliance related costs ranging from $67 to $95 per acre.
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Saturday, July 23, 2011 @ 11:07 AM
posted by Beth Clay

S. 1310 the Dietary Supplement Labeling Act of 2011

Senator Durbin, the number 2 man in the Senate, (the Democratic Whip), has for many years attempted to undermine the hard won victories of Proxmire, NLEA, and the Dietary Supplement Health and Education Act of 1994 (DSHEA). He has launched a new battled against the dietary supplement industry with the introduction of S. 1310 the Dietary Supplement Labeling Act of 2011. This can only spell trouble for the industry and the consumers who rely on supplements.

One company selling single serving products (Lazy Cakes) Melatonin ‘Brownies’ along with energy drinks that the FDA is looking to target, have given Senator Durbin a ‘Consumer Protection’ platform from which to launch legislation that would have much broader implications. This is a strategy that cannot be ignored or underestimated.

Senator Durbin Wants to Give the FDA Even More Power: In typical Durbin fashion, he issued press statements and introduced the legislation just as Congress was headed home for the July 4th holiday week. Also true to form, the press statements and the actual text of the legislation tell different stories. According to press accounts, Senator Durbin is seeking to have the FDA draw a strong line between dietary supplements and food additives, the Durbin/ Blumenthal “legislation would require FDA to establish a clear definition of which products are foods and should be regulated as such and which products are meant to be health aids and should be regulated as dietary supplements. “ If that was not bad enough (there is no indication that the drafts of DSHEA intended for a hard line to be drawn between foods and supplements), his legislation goes much further. Durbin’s proposed legislation chips away at the founding principles of food law as they relate to dietary supplements, pushing both closer to the drug regulatory framework, which even Pharma says is too lengthy and too costly. (Currently it is estimated that a drug company will spend around $1 billion and a dozen years to get a product approved.)

S. 1310:

Adds Additional and Burdensome Registration Requirements for Manufacturers;

Seeks to Supersede US Law with the Implementation of a European Union Style List of food ingredients and products which can be sold as supplements; and

Will Be the Death Knell for Proprietary Blended Products.

Dietary Supplements and other Food are Already Heavily Regulated: All foods including dietary supplements are already heavily regulated. In the last few years Congress has passed major legislation including the Food Safety Bill that the FDA is working to implement.

Further, DSHEA, which was passed into law in 1994, has components that are not yet fully implemented. The laws on the books are sufficient to address the melatonin brownie issue as well as any questions about energy drinks; a concerted grassroots effort is needed to educate those involved and stop this bill from progressing. So far only Senators Durbin and Blumenthal are cosponsors. A concerted effort is needed to keep it that way.

Even if the Bill does not move through regular order in the Senate, Durbin is very powerful, may try to insert the Bill language into another Bill that is moving, so we will need to maintain vigilance and insure other Senators do not go along.

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Thursday, July 21, 2011 @ 01:07 PM
posted by admin

The global POP Campaign was founded to educate and to promote the power of the community of consumers and industry of the organics movement in preserving and promoting organic foods, dietary supplements, overall health and food freedom.  POP played a significant visible role throughout the process of making the Food Safety Bill, S-510, a much better bill.

The three-legged prongs of power for the POP Campaign to gain strong influence are Health oriented providers; Grass roots support and outreach, and Grass tops – industry participants.

The Campaign is poised to play a key role in coalition building with other representative groups, businesses, health practitioners and educators so as to strengthen its voice and leverage impact throughout the world.

Foods and Supplements Are Inexplicably Linked

In the U.S., as you know, dietary supplement rules and regulations are under the umbrella of food regulations as dietary supplements are considered foods, not drugs. Even without the regulatory connection, foods and supplements are inexplicably linked, as most dietary supplement ingredients are food based. Some dietary supplement companies only use organic food products to produce their supplements. This “linkage” is a point of contention among regulators; and, Congress continues to clarify the regulatory framework. Within this contentious context, POP’s role is essential on an ongoing basis to ensure an educational role and watchdog presence.

CODEX Threat to Supplements and the Dangers of a CODEX to U.S. Bleed-through

CODEX is a very specific threat to supplements worldwide, including potential bleed through to US policy. A major stage has been set as seen in occurrences in the international arena where the European Union, led in large part by the same players who are on their CODEX Delegations, passed a law several years ago requiring prior approval of supplements before entering the market place.  As we saw this year, this has dramatically limited product access.  Because the EU does not have the protections of the Proxmire Amendment, they have succeeded in setting upper limits on vitamins that are below the therapeutic threshold.

Although the Proxmire Amendment withheld challenges by the FDA and got ultimately folded into DSHEA, the threat remains to undercut this cornerstone. (Most recently the introduction of S 1310, the Dietary Supplement Labeling Act of 2011 which you will hear much more on soon.) Every significant piece of food and supplement legislation that has passed has a section pertaining to the coordination and compliance of that legislation with ANY treaty or international agreement the US has signed. Any treaty has CODEX rules as the driver, giving that agreement a trump card for over-riding any food policy and freedoms allowed so far within the U.S.

Besides the obvious protections in place, and the introduction of S-1310, are there still any tangible threats? Yes, threats to DSHEA in the near future exist.  On the front burner, the FDA’s egregious tactics where they raided the Amish Farm and the Oregon Maxam Nutraceutics supplement company with scores of armed agents shows their mindset – if you are small and ‘alternative’ you are a target.  Further, there are legislators such as Waxman and Susan David, who are always looking for ways to overturn DSHEA.  Again, the FDA continues to seek ways to get around DSHEA, they want drug like pre-market approval requirements and revive this at every level possible.

A small counter step was taken in 2010 where, for the first time pertaining to the CODEX and trade amendments in any legislation, the POP Campaign specifically shared process information with the Senate to amend the Food Safety Bill CODEX section to include FDA accountability language and a two-year report back to the Senate on the impact of CODEX on Food and Organic products. This is the first time that this has happened.

Another huge counter influence is the media where it continues to state fraudulently that dietary supplements are not regulated (or the new phrase, are ‘barely’ regulated) and run sensational dramatic stories to gain readership. The POP Campaign has made concerted efforts to be a source of reason, truth, and clarity and has helped share information and reframe the dialogue around these issues. In 2010, it garnered public statements for the record by Senators Harkin and Hatch that the FDA cannot adopt CODEX Guidelines affecting dietary supplements without Congressional Approval.

The ongoing work in CODEX has to do with setting reference values on vitamin and mineral supplements.  This is very controversial and will be used to expand this attack on supplements to the global market place and demand conformity to participate in trade issues. Furthermore there are activities in process or in development that will or may specifically affect individual products and where the POP Campaign can have a stronger presence and share information, for example in the cases of Noni and Kava (as seen in the note below).  Some additional supplement microscope activity is seen around Blue-green algae, Ginko Biloba, Acidophilus and probiotics to just mention a few. (Please see below.)

As CODEX bleed-through gains momentum as seen in FDA, Trade, Agriculture, etc. U.S. Departments agendas, these efforts to solidify and seek CODEX alignment require constant vigilance and education – a role the POP Campaign plays.

Legislative Policy Presence and Education Savvy

The POP Campaign plays a strong role of “health educator” and has a presence in DC – this presence being vital in connecting with legislators and key staff. Knowing how to script the message and what areas to provide information with certain legislators and policy makers is crucial to success. Strengthening this connectivity for back channel communications, leveraging, educating, and “getting the scoop” is the backbone of the long-term relationships of the Capitol consultants we work with.

The history includes time spent in the Office of Alternative Medicine, House Government Reform Committee oversight for expanding the health care system to include dietary supplement regulation, participating in numerous hearings that progressed into DSHEA, participated as a delegate to CODEX ‘S special Nutrition Committee, represented 6 million constituents in California, and much more.

So many areas are in development pertaining to food and supplements where POP has a role, for example, our DC presence helped garner several million in research dollars for alternative medicine research through appropriations. This is significant as a tactic for food and supplements because alternative medicine is tied to supplements both philosophically and as a means of therapy.  Every alternative system of healing uses nutrition as the first line of therapy and alternative medicine research dollars often are used for looking at nutritional supplement evaluation.

Grass Tops – Key Alliances

Many times, more powerful even than grassroots are well-positioned grass tops – business executives and owners from the industry willing to give support and speak out. The power of a business owner talking to a legislator is significant.  Business owners equal jobs and  are perceived as friendly territory for garnering support in future elections.  The POP Campaign has the ability to form sound coalitions with business owners and “grass tops” based upon sound thinking and without compromising its positions on organics on every side of policy education.

At the same time, there is no take away from the power of the consumer, and Congress generally wants to do the right thing. Grass roots and tops, providing accurate information and supporting each other through the POP Campaign, can forge new alliances, provide information of new standards, and maintain a complete organic presence.

POP Campaign’s Role Crucial in the US and CODEX Policy Making

Congress is becoming very interested in how the FDA is setting priorities and is engaging with them now about protecting the organic and supplement industry and consumers’ access. This is a high priority for the community. Equally, with CODEX policy making, the POP Campaign can play an important role.

1.        Educating the public about what is happening at policy-making levels – especially proving to be an accurate source of information on a topic where there is so much misinformation. (On the Food Safety Bill, there were more than 200 radio interviews and numerous articles and hundreds of group appearances.)

2.                   Solidifying and expanding the POP Campaign support base, especially through its global Moms for Preserving Organic Power initiative – MOMS4POP.

3.       Educate legislators on organic food and present information as to the alignment or not with CODEX guidelines.

4.       Engage with the international community to improve guidelines within CODEX Committees.

Conclusion

There are many good ingredients in supplements and food that the FDA would love to see forced out of the marketplace.  Science and the traditional use demonstrate benefit not just to wellness, but also to disease management and prevention.  If Noni and/or algae can help with health concern, then the public is going to insist it stay in the marketplace.  The key, of course, is for supplement companies (along with others) to engage in sound discussions and build their presence in Washington by supporting the POP Campaign and being involved so that as an issue arises, they already have an inside presence.

_____________

* MOMS4POP Strategy: MOMS4POP adds a unique platform to the POP Campaign where Moms engage other Moms to keeping their voices and choices alive, keeping organic food and standards pure, keeping informed and educated as leaders and taking action to make a difference…. while making money along the way. Each Mom can realize her dreams together with other Moms, get the professional support to contribute, and build wealth while doing what they do best – being a Mom.

Notes:

Hawaiian Noni: In the fall of 2010, the CODEX Committee on North America and the South West Pacific, included discussion of Noni (also referred to as Nonu).  The Committee from Tonga is running the electronic working group after developing a discussion paper regarding the development of a commodity standard for Noni.  (The same type of process is occurring in this Committee with Kava).  The Coordinating Committee noted that there was a need to better clarify the nature, scope, safety, and intended use of Noni. The Committee also noted that a number of scientific and technical issues needed to be resolved prior to proceeding with the development of a standard.  CODEX is considering whether or not a regional or global standard on Noni is needed.

In past years, the FDA has sent warning letters to distributors of Noni regarding the a breach of the disease claims regulations.  Noni also garnered attention at the NIH, and research looking at its potential benefit for cancer is ongoing.  This can be a doubled edged sword as the design of the study is essential to the outcome, and as we have seen the in the past, not all studies at the NIH in nutrients are well designed and executed.

Blue-green algae: This is listed in the FDA’s poisonous plant database, but they do not make that connection to dietary forms of algae.  The FDA has warned companies that sell drinks with algae as dietary supplements.  There remains a need for reframing scientific points and being alert.

Ginko Biloba: The large clinical trial on ginko at the NIH is a prime example of government corrupting the scientific process.  All of the experts agreed from the outset that the study design could not answer the key question (whether or not the use of ginko in seniors would delay the onset of Alzheimers.) The study as anticipated was negative.

Acidophilus and probiotics: The dramatic rise in the popularity of pro and prebiotics has stimulated interest at the NIH and FDA.  It is one of the incidences in which the benefits are widely known and have become mainstream.  Activia’s advertisements were recently required to change their commercials.

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