The market for biological-based crop inputs is rapidly growing in Latin America (LATAM). This fact is no surprise to Elemental Enzymes LATAM Regional Director Paulo Campante, Ph.D. A career regulatory expert, he has worked in Brazilian federal government agencies, as well as in private industry and agricultural associations as a regulatory liaison and consultant, for more than 20 years. 

Right now, Campante is working with agencies in Brazil and other LATAM countries in the process of reviewing Elemental products for approval. The company already has some crop input products registered in Brazil, Argentina, Paraguay, Ecuador, and Costa Rica, along with several submissions awaiting approval in Mexico, Uruguay, and Colombia.

Growers in South America, Central America, and Mexico are receptive to biological crop solutions to fertilize, fortify plant defenses, and mitigate stress damage and loss. Various legislatures are working to update old regulations that only evaluated the efficacy and impact of conventional chemicals on plants and the environment. This means that Elemental’s products sometimes have a shorter approval process than they would if they were evaluated as traditional chemicals.

“In Brazil, for example, the government decided a few years ago that biological products should get regulatory preference, and approved a fast-track review process for them,” Campante says. “This process takes perhaps one-and-a-half or two years, whereas new conventional chemicals like a new pesticide would take eight or even 10 years to review.”

Insight on the process

No two LATAM countries have precisely the same federal review process, but Campante says they follow similar logic. Brazil is a good example when discussing the demand for biologicals and the approval process with respect to LATAM nations. Not only is Brazil the largest country in LATAM, but it is also the region’s largest single market for these products.

The first step in applying for registration is typically to classify the product by what it is and its mode of action (MOA). The process evaluates the product’s agronomic efficiency along with potential environmental and human health risks. The second step is to note its characteristics and performance in the field.

In Brazil, multiple government agencies are required to sign off on any agricultural product with a pest or disease control MOA, also called biodefensives. These agencies are the Ministry of Agriculture, Livestock, and Food Supply (MAPA), National Health Surveillance Agency (ANVISA), and Brazilian Institute of Environment and Renewable Natural Resources (IBAMA).

A multi-agency approach for crop input chemicals is typical in LATAM countries, as opposed to singular agency approval from the U.S. EPA. MAPA evaluates how well the product actually performs in the field. ANVISA reviews it for toxicological impact on humans and animals, and IBAMA evaluates it for environmental safety. “There is a complementary relationship among all three agencies, in analyzing biological inputs for use in our agriculture,” Campante says.

The process of registering a fertilizer is not quite as involved and often shorter. MAPA alone reviews these products, which must be free from agrochemical substances to be approved. Also covered by this category are inoculants, soil amendments, and biofertilizers. Federal approval is sufficient for these products to be used across Brazil, while state governments generally need to also individually approve the pest-control products following federal registration.

Adapting to change

Products that fall under the “biologicals” category in Brazil enjoy a shorter federal approval process than conventional agricultural pesticides, thanks in part to the fact each of these three agencies has a dedicated team analyzing biological submissions.

Campante says there is ongoing discussion in the National Congress of Brazil about legislation to define and regulate biological products. There is currently no separate legislation that reflects how biological products differ from conventional farm chemicals in both MOAs and research requirements. Until something separate is enacted, biological inputs will continue to be evaluated under conventional standards.

Elemental itself is not large enough to lobby members of Congress to pass pertinent legislation. Instead, the company works through representative associations of businesses that come together

The Elemental advantage

Many of the product offerings in the LATAM biologicals space are fungal- or bacterial-based, says Campante. This is one reason Elemental Enzymes has an advantage. Elemental’s technology brings together the shelf-stable benefits of natural, non-toxic enzymes and peptides without off-target effects. These technologies also avoid the difficulties commonly encountered in producing, adapting, shipping, and storing live microorganisms in different environments.

Further, there are not many companies in the biologicals space in this region offering enzyme- or peptide-based products. Elemental’s products are naturally derived from plants and

microbes to do specific tasks, which they are ready to perform as soon as added to the soil. 

Unlike microorganisms, Elemental’s inputs can perform their designated activity under a wide range of conditions. These activities include increasing nutrient uptake, improving soil health, and stimulating microbial activity. Elemental scientists draw from peptides to develop pesticide applications that awaken and stimulate the plant’s own defenses rather than attacking the pathogen directly.

One reason LATAM farmers are willing to embrace these products is that a longer growing season means double- and even triple-cropping fields. In Brazil, this typically means soybeans, corn, cotton, and wheat. Intensity of both land use and pathogen pressure means growers are looking for effective tools to manage diseases like Asian soybean rust, corn stunt disease, and Citrus Greening. The challenge is doing so in a way that doesn’t contribute to chemical resistance and saves on input spending. They also find value in the plant stress mitigation tools Elemental develops using amino-acid biochemistries.

Another reason Elemental technology is well-positioned to increase its products’ usage in LATAM farming stems from regulations at the end destinations for exports such as fruit, coffee, and more. In particular, the U.S. and European countries have tightening standards for chemical residue in agricultural products. Consumers want to know more about where their food comes from and how it’s raised, exerting market pressure to cut down on conventional chemical application.

“With our strongly science-backed products, Elemental sees great potential to work with existing and potential industry partners in Latin American countries, because we can fulfill what growers want to use in the market right now,” Campante notes.