Farming’s transformation starts to change Africa

By Marshall Matz, as published in the Des Moines Register

Next month President Barack Obama is hosting an Africa summit with heads of state and corporate chief executive officers. The timing is excellent.

Africa’s unique green revolution, with its focus on smallholder farmers, is now moving beyond the tipping point. And as smallholder farmers make the transition from subsistence farming to successful entrepreneurs, the continent’s green revolution will fundamentally change the face of Africa.

Last month, the African Union met to mark the 10th anniversary of its comprehensive Africa agriculture development program. The program called on all African governments to invest at least 10 percent of their budgets in agriculture. The new goal is to at least double agriculture production by 2015, sustain annual agriculture GDP growth of at least 6 percent; triple intra-African trade in agricultural commodities and services; create job opportunities for 30 percent of the youth; and end hunger in Africa by 2025.

This bold agenda is doable. Half of those who are hungry in Africa are smallholder farmers. As they move from subsistence farming to entrepreneurs it will change the face of Africa.

While the White House summit will focus on many of the broad issues facing Africa, it will include agriculture and food security. Agriculture is the area where the president has the greatest opportunity to make his mark.

According to Strive Masiyiwa, founder and chairman of Econet Wireless, co-chair of GROW Africa, and chairman of the board of the Alliance for a Green Revolution in Africa, “With broad action on policy, investment and technology, Africa’s farmers can double their productivity within five years.”

The White House African leaders summit is not just important to Africa. It is important to the United States. Six of the fastest-growing economies in the world are in Africa, and Africa is becoming a major market and potential trading partner for U.S. companies.

Further, over half of all the underutilized and unused agricultural land in the world is in Africa. As a result, it is not possible to achieve global food security without Africa. Finally, Africa is an important strategic partner for U.S. national security.

As President Obama said in Tanzania last summer, “In our global economy, our fortunes are linked like never before. So, more growth and opportunity in Africa can mean more growth and opportunity in the United States. And this is not charity; this is self-interest. And that’s why a key element of my engagement with Africa, and a key focus during this trip, has been to promote trade and investment that can create jobs on both side of the Atlantic.”

The attention on African agriculture these past few years is already having a major impact on the ground as it reaches Africa’s smallholder farmers. The immediate focus in Africa is on the 18 African countries that comprise the continent’s two breadbasket regions.

The coordinator and spark plug for translating much of the political attention is the Alliance for a Green Revolution in Africa, working with the African Union, the private sector and other stakeholders. Their bold initiative focuses on seed development, soil health, markets, capacity building, credit and public policy across the African continent.

Plant breeders supported by the Alliance for a Green Revolution in Africa have so far developed over 440 new and improved crop varieties, many of them now starting to increase smallholder productivity. They have helped to establish and strengthen more than 80 private, African-owned and operated seed enterprises. These now produce more than 80,000 metric tons of certified seed of key staple food crops each year — up dramatically from less than 2,500 metric tons in 2006.

More than 1.5 million farmers are now using integrated soil fertility management technologies. Over 2,500 farmer organizations have received intensive business and management training, enabling them to become more sustainable and effective in meeting the needs of smallholder farmers. Some 20,000 agro dealers have been established in rural communities to distribute improved seeds, fertilizer and other inputs. The privately owned agro dealers are also providing extension services to their customers. A more detailed summary of the state of play on the ground in Africa can be found in the Alliance for a Green Revolution in Africa’s 2013 annual report.

At the end of 2013, Kofi Annan, the former secretary general of the United Nations, stepped down as chairman of the Alliance for a Green Revolution in Africa and became its chairman emeritus. In doing so, he said, “We can move forward together knowing that the transformation of African agriculture is now well under way, and has the momentum needed to achieve our shared vision of a uniquely African Green Revolution.”

The secretary general is correct. The African green revolution is well under way. President Obama has the opportunity to greatly increase the pace of that momentum by building on his past leadership and identifying specific goals for future action.

MARSHALL MATZ specializes in agriculture and global food security at OFW Law in Washington, D.C. He serves on the board of directors of the World Food Program USA and the Congressional Hunger Center. He was formerly counsel to the U.S. Senate Agriculture Committee on Agriculture.

John Block: Getting Nothing Done

By John R. Block

Today, I want to talk to you about the deficit – not the dollar deficit. That’s for another day. I want to talk about the deficit of action, the deficit of responsibility.

The U.S. Congress and the President have failed the people. The end of this fiscal year is fast approaching and the Congress (once again) has not completed the appropriation process for next year’s spending. The House Ag Appropriations bill still has not been passed. The Senate Ag bill is stalled and going nowhere.

There is very little time left. The house is scheduled to be in session 4 more days this month – zero days in August – only 10 days in September and 2 days in October.

We’re not going to complete the appropriations process. We’ll do what we have done before. We’ll pass a continuing resolution to keep the government running and funded until after the November mid-term election. Then, the Congress will vote the funding for next year.

Why don’t they get the work done on schedule? The answer is they don’t want to vote on issues now because their vote might hurt their chances of getting reelected. Harry Reid, leading the Senate, is sitting on a basket of bills that the House has approved. He just sits on them. As an example, if he were to allow his Senate Democrats a vote on a bill to stop EPA’s attack on coal-fired plants, it might pass. Coal state Democrats would vote for it. They would have to if they want to get reelected.

President Obama isn’t up for reelection. Why isn’t he in there leading to get things done? He had said at one time he wanted to reform the tax code “riddled with complicated loopholes.” He has done nothing. He wants to negotiate a European trade deal and a Pacific agreement. He doesn’t even have “trade promotion authority.” Any hope we had for immigration reform is lost for now with the thousands of Central American children streaming through our unsecured border.

The list of important issues that need to be dealt with is endless. If you wonder why the Congress is in session for only 16 days over the next three months, it’s because they are on the campaign trail. My advice to you is – go to their events and ask them why they aren’t getting anything done. Tell them, “Quit telling us what you’re going to do. Just do it.”

John Block was Secretary of the U.S. Department of Agriculture from 1981-1985, where he played a key role in the development of the 1985 Farm Bill.

OFW Law Celebrates 35 Years of Successes: Food/Dietary Supplements Practice Team

By Michael J. O’Flaherty

Thirty-five (35) years ago, the Washington, DC law firm presently known as Olsson Frank Weeda Terman Matz PC, or simply “OFW Law,” originated as Olsson and Frank, P.C.  It was comprised of two (2) founding attorneys, Philip C. (Phil) Olsson and Richard L. (Rick) Frank, who left another DC law firm to start their own.  Anita Harris (still with the firm as its Director of Finance) moved with them as their legal administrator.

Since its 3-person inception, OFW Law has represented a growing number of conventional food and dietary supplement clients, including manufacturers, distributors, food service establishments, and trade associations.  Over the years, the firm’s Conventional Foods and Dietary Supplements practice groups have grown considerably.  Practitioners at the firm presently engaged in addressing issues in these areas now number 15 and include both attorneys and government relations personnel (i.e., Senior Policy Advisors).

OFW Law’s food/dietary supplements practice team has attained countless successes for our clients in its 35-year history.  Many of these successes were (and must remain) confidential matters.  Nevertheless, some examples of our practice team’s undertakings provide insight into our capabilities:

  • Our professionals were instrumental in the enactment of the Nutrition Labeling and Education Act (NLEA), the FDA Modernization Act (FDAMA), the Public Health Security and Bioterrorism Preparedness and Response Act (Bioterrorism Act), the Food Allergen Labeling and Consumer Protection Act (FALCPA), the FDA Amendments Act, and the FDA Food Safety Modernization Act.  We also have been actively involved in rulemakings to establish regulations implementing these statutes, as well as in implementation and utilization of the regulations.
  • Our practice team, in a matter that spanned 5 years, assisted a client in securing millions in capital (i.e., dollars and shares) from a “milestone” provision in a merger agreement that opposing counsel had deemed unearned and unattainable.  The matter essentially entailed petitioning FDA for a nutrient content claim; motivating the agency to authorize the claim through discussions with Congressional staff, high level administrative personnel, and attorneys in the Office of Chief Counsel; and (once authorized) collaborating with litigation co-counsel to achieve resolution of the contractual dispute.
  • We partner with our client, The Food Institute, by authoring practical publications for sale, including:
  1. HACCP & U.S. Food Safety Guide (2nd edition);
  2. Food Industry Bioterrorism Act Guide;
  3. Dietary Supplements: A Regulatory Guide;
  4. Guide to Regulation of Food Ingredients and Food Packaging Materials;
  5. Food Labeling Guide (3rd edition);
  6. Importing Food Into The United States;
  7. Guide to Handling FDA Food Inspections (2nd edition); and
  8. Food Products Recall Manual (4th edition).
  • Our professionals have worked with numerous clients to determine the status of their food ingredients under the generally recognized as safe (i.e., “GRAS”) provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 321(s).  We have filed many successful GRAS Notifications for various food ingredients, including: potato and oat hull fibers; cultured dairy, fruit and vegetable materials; cultured corn, cane or beet sugars; and carbon monoxide.
  • Our practice team has represented top food and beverage companies in competitive disputes involving misleading labeling and advertising claims.  Using both traditional and untraditional strategies, our actions on behalf of clients led to cessation of the challenged claims and the restoration of a level competitive playing field.
  • Pursuant to amendment of the FD&C Act to include section 403(h)(3)(B) (21 U.S.C. § 343(h)(3)(B)), we represented a client by preparing and submitting to FDA’s Center for Food Safety and Applied Nutrition a successful notification to authorize in-shell eggs, treated by a proprietary process according to specified minimum processing parameters, to be represented in labeling as “pasteurized.”
  • We have helped several clients obtain temporary marketing permits (TMPs) authorizing the interstate shipment of packs of food varying from the regulatory requirements of FDA’s definitions and standards of identity (e.g., canned fruit cocktail, canned tuna), many of which have not been updated in more than a quarter century.

Like OFW Law generally, our practice team is adept at providing clients with creative solutions to difficult problems.  We look forward to another 35 years of successes.

Bill Introduced to Ban the Use of Bis-Phenol A in Food Packaging

By Mark L. Itzkoff

On July 10, 2014, Senator Ed Markey (D-MA) introduced a bill (S. 2572) to ban the use of Bis-phenol A (BPA) in food packaging.  The bill was also introduced in the House of Representatives (H.R. 5033) by Reps. Lois Capps (D-CA) and Grace Meng (D-NY).

According to a press release issued by the bill’s co-sponsors:

The Ban Poisonous Additives Act … would remove BPA from food packaging, encourage the development of safer alternatives, and ensure a thorough safety review of all substances currently used in food and beverage containers. The bill also would require the Food and Drug Administration to examine the effects of BPA on workers who may have been disproportionately exposed to BPA during the manufacturing process.

In terms of food packaging applications, BPA is primarily used in the production of polycarbonate (21 C.F.R. § 177.1580(a)) and as a component of epoxy can coatings (21 C.F.R. § 175.300(b)(3)(vii)).  FDA repealed approval for the use of polycarbonate resin in the production of baby bottles and “sippy cups” in 2012, in response to a petition from the American Chemistry Council.

The full text of the bill is not yet publicly available.  We will update this post as soon as the text is published.

FDA Issues Guidance Documents on the Use of Nanotechnology in FDA-Regulated Materials 1

By Mark L. Itzkoff

On June 24, 2014, the Food and Drug Administration (FDA) released three final and one draft guidance document regarding the use of nanotechnology in the manufacture of FDA-regulated products.  Specifically, the agency issued the following:

Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology

While FDA has not established a regulatory definition for “nanotechnology,” the agency notes that the term is generally used to describe “materials that have at least one dimension in the size range of approximately 1 nanometer (nm) to 100 nm,” where the unique dimensions enable novel applications.  In the Guidance Document, FDA sets forth two points to consider when determining whether an FDA-regulated product involves the application of nanotechnology:

  1. Whether a material or end product is engineered to have at least one external dimension, or an internal or surface structure, in the nanoscale range (approximately 1 nm to 100 nm).
  1. Whether a material or end product is engineered to exhibit properties or phenomena, including physical or chemical properties or biological effects, which are attributable to its dimension(s), even if these dimensions fall outside the nanoscale range, up to one micrometer (1,000 nm).

FDA uses the term “engineered” to differentiate materials intentionally designed or manufactured to contain nanomaterials from those that naturally contain material in the nanoscale range.  The term “material or end product” is used to include the range of products regulated by FDA, including finished products (e.g.,a drug tablet) and materials used to produce the end product (e.g., a food additive).

The agency concludes that if a material or end product is “affirmative” for either point, additional attention may be needed to determine the safety of the material.

Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives

FDA approaches nanomaterials from current food substances (i.e., for the purposes of the Guidance Document, FDA uses the term “food substance” to include food additives, color additives, GRAS ingredients and food contact substances) in the same manner as it approaches food substances produced using a process that entails significant changes in the manufacturing process. The guidance document suggests that materials produced with any new process be evaluated to determine if a new regulatory submission is warranted.  In the food ingredient guidance document, FDA lists the factors that should be considered when reviewing the regulatory status of the new material:

  • A change in one or more starting materials;
  • A change in the concentration of starting materials;
  • A change in catalyst;
  • A change in the source microorganism (including a change in strain) used for a food substance derived from fermentation of a microorganism; and
  • A change in food manufacturing or ingredient technology, such as the use of emerging technologies that affect the particle size distribution of a food substance.

Any of these changes may require a new “regulatory filing” if it results in a significant change in the safety or intended use of the food substance.  For example, the use of nanotechnology to produce a food additive may increase the amount of the additive that is absorbed through the digestive system, which may require a new safety evaluation.

Of particular interest is the agency’s discussion of the impact of nanotechnology on food substances deemed to be generally recognized as safe (GRAS) when produced using conventional production methods.  FDA notes that in some situations, “manufacturing changes are so novel as to preclude general recognition of safety.”  Furthermore, FDA notes that when nanotechnology or other emerging technologies are used, the technology may be “so new as to preclude a consensus among experts that the use of a food substance manufactured using that technology is safe, thus precluding a determination that the use of the food substance is GRAS” (emphasis added).

Safety of Nanomaterials in Cosmetic Products

This Guidance Document notes that, except for color additives, substances used in cosmetic products are not subject to FDA premarket approval.  It is the responsibility of the cosmetic manufacturer to ensure that the product is not misbranded or adulterated.  FDA states that the general principles for evaluating the safety of nanomaterials are the same as the principles for evaluating conventional materials.  However, nanomaterials “may exhibit new or altered physicochemical properties that may affect biological interactions, which may raise questions about the safety of the product containing nanomaterials.”  These new or altered properties must be addressed as part of the overall safety evaluation.”  The guidance document includes specific recommendations on the components of a safety evaluation for nanomaterials, including characterization of the material and toxicology considerations.

Use of Nanomaterials in Food for Animals

In addition to the three final guidance documents discussed above, FDA issued draft guidance on the use of nanomaterials in food for animals.  The agency notes that at the current time there are questions related to the “the technical evidence of safety as well as the general recognition of that safety” that would preclude a GRAS determination.  FDA states that these questions are sufficient to “warrant formal premarket review and approval by FDA.”  For this reason, FDA suggests that nanotechnology-based animal feed ingredients be submitted for review as a food additive petition (FAP).  The draft guidance includes recommendations on the contents of a FAP for these materials.