Last November 13,2015 FDA finalized the rules of implementing the bipartisan Food Safety Modernization Act (FSMA) that, for the first time, establish enforceable safety standards for produce farms and make importers accountable for verifying that imported food meets U.S. safety standards. (For full final rules and requirements for each key elements below, read http://www.fda.gov/Food/GuidanceRegulation/FSMA/)
Here are the 7 Foundational Rules under FSMA:
- Preventive Controls for Human Food: Requires that food facilities have safety plans that set forth how they will identify and minimize hazards. Original rule proposed January 2013; supplemental rule to add specific language for important provisions proposed September 2014. Final rule issued: Sept. 10, 2015.
- Preventive Controls for Animal Food: Establishes Current Good Manufacturing Practices and preventive controls for food for animals. Original rule proposed October 2013; supplemental rule to add provisions geared specifically to animal foods proposed September 2014. Final rule issued: Sept. 10, 2015.
- Produce Safety: Establishes science-based standards for growing, harvesting, packing and holding produce on domestic and foreign farms. Original rule proposed January 2013; supplemental rule to amend key areas proposed September 2014. Final rule issued: Nov. 13, 2015.
- Foreign Supplier Verification Program: Importers will be required to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of U.S. food producers. Original rule proposed July 2013; supplemental rule to provide, among other provisions, more flexibility in determining appropriate verification measures proposed September 2014. Final rule issued: Nov. 13, 2015.
- Third Party Certification: Establishes a program for the accreditation of third-party auditors to conduct food safety audits and issue certifications of foreign facilities producing food for humans or animals. Proposed July 2013. Final rule issued: Final rule issued: Nov. 13, 2015.
- Sanitary Transportation: Requires those who transport food to use sanitary practices to ensure the safety of food. Proposed January 2014. Final rule deadline: March 31, 2016.
- Intentional Adulteration: Requires domestic and foreign facilities to address vulnerable processes in their operations to prevent acts intended to cause large-scale public harm. Proposed December 2013. Final rule deadline: May 31, 2016
Preventive Control for Human Food and Animal Food program shall be covered by:
- Facilities that process, pack, or hold human food.
- Domestic and Imported Food.
Some exemptions and modified requirements apply (see below).
For the purposes of FSVP:
What is an “Importer”?
an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agency or representative of the foreign owner of consignee at the time of entry, as confirmed in a signed statement of consent.
Importers are responsible for actions that include (and are explained further below):
- Determining known or reasonably foreseeable hazards with each food
- Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance
- Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities
- Conducting supplier verification activities
- Conducting corrective actions
Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
Importers are required to develop, maintain and follow an FSVP for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers.
Certain importers that are also manufacturers/processors are deemed in compliance with most FSVP requirements if they are in compliance with the supply-chain program requirements under the preventive controls rules; they implement preventive controls for the hazards in the food in accordance with the requirements in the preventive controls rules; or they are not required to implement preventive controls under those rules in certain specified circumstances. Examples of such circumstances include when the type of food (e.g., such as coffee beans) could not be consumed without application of a preventive control, or when the customer will be significantly minimizing or preventing identified hazards) and they comply with requirements for disclosures and written assurances.
The evaluation of the risk posed by the imported food and the supplier’s performance must be reevaluated at least every three years, or when new information comes to light about a potential hazard or the foreign supplier’s performance.
Importers are not required to evaluate the food and supplier or conduct supplier verification activities if they receive adequate assurances that a subsequent entity in the distribution chain, such as the importer’s customer, is processing the food for food safety in accordance with applicable requirements. Importers must also disclose in documents accompanying the food that the food is not processed to control the identified hazard.
Compliance Dates for Produce Safety Rule
Compliance dates for covered activities, except for those involving sprouts, after the effective date of the final rule are:
- Very small businesses, those with more than $25,000 but no more than $250,000 in average annual produce sales during the previous three year period : four years
- Small businesses, those with more than $250,000 but no more than $500,000 in average annual produce sales during the previous three year period: three years
- All other farms: two years
The compliance dates for certain aspects of the water quality standards, and related testing and recordkeeping provisions, allow an additional two years beyond each of these compliance dates for the rest of the final rule.
Compliance dates for modified requirements for farms eligible for a qualified exemption are:
- For labeling requirement (if applicable): January 1, 2020
- For retention of records supporting eligibility for a qualified exemption: Effective date of the final rule
For all other modified requirements:
- Very small businesses, four years after the effective date of the final rule
- Small businesses, three years after the effective date of the final rule
Compliance dates for covered activities involving sprouts after the effective date of the final rule are:
- Very small businesses: three years
- Small businesses: two years
- All other farms: one year
Produce Safety Exemptions:
- Produce that is not a raw agricultural commodity. (A raw agricultural commodity is any food in its raw or natural state)
- The following produce commodities that FDA has identified as rarely consumed raw: asparagus; black beans, great Northern beans, kidney beans, lima beans, navy beans, and pinto beans; garden beets (roots and tops) and sugar beets; cashews; sour cherries; chickpeas; cocoa beans; coffee beans; collards; sweet corn; cranberries; dates; dill (seeds and weed); eggplants; figs; horseradish; hazelnuts; lentils; okra; peanuts; pecans; peppermint; potatoes; pumpkins; winter squash; sweet potatoes; and water chestnuts
- Food grains, including barley, dent- or flint-corn, sorghum, oats, rice, rye, wheat, amaranth, quinoa, buckwheat, and oilseeds (e.g. cotton seed, flax seed, rapeseed, soybean, and sunflower seed)
- Produce that is used for personal or on-farm consumption
- Farms that have an average annual value of produce sold during the previous three-year period of $25,000 or less
- The rule provides an exemption for produce that receives commercial processing that adequately reduces the presence of microorganisms of public health significance, under certain conditions.
- The rule also provides a qualified exemption and modified requirements for certain farms.
- To be eligible for a qualified exemption, the farm must meet two requirements:
- The farm must have food sales averaging less than $500,000 per year during the previous three years; and
- The farm’s sales to qualified end-users must exceed sales to all others combined during the previous three years. A qualified end-user is either (a) the consumer of the food or (b) a restaurant or retail food establishment that is located in the same state or the same Indian reservation as the farm or not more than 275 miles away.
- A farm with the qualified exemption must still meet certain modified requirements, including disclosing the name and the complete business address of the farm where the produce was grown either on the label of the produce or at the point of purchase. These farms are also required to establish and keep certain documentation.
A farm’s qualified exemption may be withdrawn as follows:
- If there is an active investigation of an outbreak of foodborne illness that is directly linked to the farm, or
- If FDA determines it is necessary to protect the public health and prevent or mitigate an outbreak based on conduct or conditions associated with the farm that are material to the safety of the farm’s produce that would be covered by the rule.
What foods are exempt from the FSVP rule?
- Fish and fishery products that are imported from a foreign supplier that is required to comply with, and is in compliance with, FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations for those products, as well as for certain raw materials or other ingredients for use in processing fish or fishery products in compliance with HACCP.
- Juice products that are imported from a foreign supplier that is required to comply with, and is in compliance with, FDA’s HACCP regulation for those products, as well as for certain raw materials or other ingredients for use in processing juice in compliance with HACCP.
- Food for research or evaluation
- Food for personal consumption
- Alcoholic beverages and certain raw materials and ingredients that are imported for use in alcoholic beverages
- Food that is imported for processing and future export
- Low-acid canned foods, such as canned vegetables, but only with respect to microbiological hazards
- Certain meat, poultry and egg products
- Food that is transshipped, meaning it stops in the U.S. en route to another country
- U.S. food that is exported and returned without further manufacturing or processing in a foreign country.
New Food Safety Plan Requirements:
- Hazard Analysis
- Preventive Controls
- Monitoring Procedures
- Corrective Actions
- Verification Procedures
New Supply Chain requirements:
Manufacturing/processing facilities must have a risk based supply- chain program to ensure control of hazards in raw materials and other ingredients when the control is applied before receipt (“supply-chain applied control”).
New Supplier Verification Activities:
- Onsite Audits
- Sampling and Testing
- Review of Relevant Food and Safety records
- Review and Monitoring FDA Compliance Status of Manufacturers
Most FSVP requirements would not apply when importing certain food from supplier in country whose food safety system FDA has officially recognized as comparable or determined to be equivalent. New Zealand as of now
Update: FDA funding for Opportunities for Education, Training, and Technical Assistance under Food Safety Modernization Act (FSMA)
FDA Announces Funding Opportunities for Education, Training and Technical Assistance under the FDA Food Safety Modernization Act (FSMA)
The U.S. Food & Drug Administration (FDA) is announcing two opportunities for funding, in the form of cooperative agreements, to enhance food safety under the FDA Food Safety Modernization Act (FSMA). The first cooperative agreement is for Native American Tribes Outreach, Education and Training to enhance Food Safety and FSMA Compliance. The second cooperative agreement is for Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance. The outreach, education and training needs addressed in these cooperative agreements is to focus on applicable federal preventive controls regulations under FSMA, especially the Produce Safety and Preventive Controls for Human Food rules.
FSMA calls for enhanced partnerships and integration with FDA’s food safety federal, state, local, tribal and territorial partners in order to achieve public health goals. To this end, the Agency has been working with such partners to develop and implement an integrated food safety system. FDA anticipates that federally recognized tribes will need food safety education and training that addresses the regulatory requirements of the applicable FSMA rules and also encompasses specific cultural practices associated with produce farming and food manufacturing/processing within tribes relevant to their status as sovereign nations.
Also being announced today is a funding opportunity for local food producers for outreach, education and training with the purpose of enhancing food safety and FSMA compliance. FDA foresees that local food producers and processors will need food safety education and training that encompasses specific practices associated with produce farming and food manufacturing/processing relevant to their scale of production and management practices. This cooperative agreement is intended for owners and operators of small and mid-size farms and businesses involved in local food production and processing, with an emphasis on those that are involved in local food systems, while taking into account diversified, sustainable, organic and identity-preserved agricultural production and processing.
The award for the tribal cooperative agreement will be up to $750,000 each year for three (3) years and the award for the local food producer community will be $1,500,000 in FY 2016, with the possibility of two (2) additional years of support contingent upon satisfactory performance and the availability of Federal Fiscal Year funds.
The funding opportunities may be found at:
• RFA-FD-16-001: Native American Tribes Outreach, Education, and Training to Enhance Food Safety and FSMA Compliance (U01)
• RFA-FD-16-002: Local Food Producer Outreach, Education, and Training to Enhance Food Safety and FDA Food Safety Modernization Act (FSMA) Compliance (U01)