For the first time, Costa Rican growers and producers will need food safety systems in place that comply with the strict U.S. requirements established in the Food Safety Modernization Act, in order to export food to the U.S.
According to the U.S. Centers for Disease Control and Prevention, 48 million people in the U.S., or one in six, get sick each year from foodborne illnesses. Of those, 128,000 require hospitalization, and 3,000 die.
In an effort to keep the U.S. food supply safe, the U.S. Food and Drug Administration (FDA) has shifted the focus of federal regulators from responding to food contamination episodes to preventing them. The new law was signed by President Barack Obama on Jan. 4, and assigns the responsibility of keeping food safe to growers, manufacturers, distributors and importers.
Imports account for 15 percent of food consumed in the U.S., according to the FDA’s website. The number is higher for seafood (75 percent), vegetables (20 percent) and fruits (50 percent).
Agricultural products from Costa Rica accounted for $1.3 billion of U.S. imports in 2010, according to the Office of the U.S. Trade Representative. Of that number, fresh fruit (excluding bananas) represented $460 million, bananas and plantains accounted for $343 million and coffee totaled $159 million.
Although many of the law’s regulations will not take effect until 2013, some rules have already been implemented, and others will be introduced in coming months. Ricardo Molins, manager of the Inter-American Institute for Cooperation on Agriculture, said it is vital that Costa Rican producers begin modernizing now.
“We need to examine procedures and laws and decide what measures to take,” said Molins. “It’s an ongoing process of what growers and producers need to do in order to improve food safety systems.”
U.S. company J&C Enterprises, Inc., of Florida, imports chayote squash, cassava and eddoes from Costa Rica and has been working diligently with vendors in Costa Rica to ensure that quality controls are in place.
“It’s been difficult to try to reeducate [producers] to make sure that the processes are being followed through on,” said Albert Peña, the company’s import manager.
The rules that have already been enacted include increased inspections of foreign facilities, re-inspection fees and food confiscation.
The U.S. Congress has mandated that the FDA must inspect 600 foreign facilities this year, and double that every year for the next five years, according to FDA spokesman Douglas Karas. But with 254,088 registered foreign facilities, the FDA cannot inspect them all. Karas said that U.S. lawmakers are discussing a system for accredited third parties to help the FDA meet the inspection requirements.
According to Karas, much of what the FDA does is based on risk. “We have a risk management tool that helps us determine which shipments will get inspected or further scrutinized based on a combination of factors such as the risk of the food and the past history of the facility that it came from,” said Karas. “The tool is also flexible enough to be altered if there is a problem with a type of product already in the market.”
The FDA will mandate record-keeping requirements for companies that produce high-risk foods. The agency still needs to determine which foods are considered high-risk, although Karas indicated that factors could include how prone a food is to contamination and how widespread an outbreak would be if one were to occur.
“If an importer has had a shipment of food, including food for animals, rejected by another country, the importer must inform the FDA of the product rejection,” said Karas.
Re-inspection fees of a facility or a shipment have been established. Costs run between $224 and $325 per hour depending on whether foreign travel is necessary for FDA agents. A re-inspection would occur if an initial inspection of a facility had failed or an importer wanted to resubmit a shipment that had been sampled and failed inspection. The importer would be responsible for the fees.
Peña said that if negligence were shown to be the fault of the producer, the producer would be required to pay the fee.
Since July, the FDA has been allowed to stop food entering the U.S. for up to 30 days if the agency has reason to believe it is adulterated or misbranded. Examples of this include the use of an unsafe chemical, food additives or missing or incorrect nutritional information.
Two new laws that the FDA will draft and present to Congress by January 2012 will impact Costa Rica growers and producers.
Food-processing facilities will need a Hazard and Critical Control Point Plan in place. The plan requires that facilities determine what potential microbes or bacteria pathogens could contaminate the food they produce and develop controls to prevent it from happening. It also involves having a plan to respond to contamination in the event that it happens. Seafood, juice and low-acid canned food will be exempt from the law, as they already implement such a plan.
The second law will pertain to produce. Previously, produce safety relied on guidelines that farmers and producers were merely encouraged to obey. The new produce safety law will be a set of enforceable rules that will instruct farmers, producers and distributors what they must do to keep food safe from the farm to a consumer’s table.
Smaller producers in Costa Rica could have more difficulty ensuring that their facilities meet these new requirements. “Many larger companies already have food safety regulations in place and perform hazards analysis, while smaller companies don’t have the technology to understand where hazards lie and will likely have more trouble,” said Molins.
Costa Rican producers and manufacturers may find themselves overwhelmed by the large number of new regulations. The FDA Regional Office for Latin America, based in San José, has been working to help Costa Rican exporters understand and decipher the rules. In addition to videos and several key documents in Spanish available at www.fda.gov/fsma, the FDA regional office has held numerous briefings and workshops this year. The Foreign Trade Promotion Office will be hosting a Web stream on Oct. 25.
For the understaffed and underfunded FDA, implementing the new rules will be difficult. The U.S. Congress authorized $200 million less than the $955 million requested by the FDA for its 2012 fiscal year “Human Foods Program,” which covers all food safety programs. And an April 6 Annual Report to Congress stated that the FDA was only able to physically examine 2.1 percent of foods that entered the U.S. last year.
“A lot will depend on what leveraging the FDA can do in terms of using resources from other organizations and agencies,” said Karas.
And although producers and importers may get stuck with the initial costs of inspection fees and upgrading facilities, inevitably the cost will be passed on to consumers in the form of higher food prices.