An Overview of FSMA for AOOPA
by Jon Kimble, DFA (www.dfaofca.com)
Summary of FDA’s Recently-Released Preventive Controls Rule
By now you’re probably already aware that the final Preventive Controls rule was released by FDA mid-September of this year. It’s one piece of the overall FSMA “pie” that FDA is publishing over the course of about 9 months or so, and applies directly to the operations of nearly all food processors in the Unites States. One important thing to understand is that most food operations will either fall under the Produce Safety rule, which is roughly equivalent to “good agricultural practices” and will be released in a few weeks, or the Preventive Controls rule, which is analogous to HACCP. In this article we’ll provide an overview of the requirements of the PC rule, but if you have any further questions we’re available to help!
Requirements: The 10,000-Foot View
We can’t cover all the details of the requirements in this article, as the rule itself is about 100 pages and there were about another 800 pages of additional discussion. So we’ll give you a quick overview here. The sections of the Preventive Controls rule can be summarized as follows:
· Subpart A: General Provisions
· Subpart B: Updates to the GMPs
· Subpart C: Food Safety Plan Requirements
· Subpart D: Modified Requirements
· Subpart E: Withdrawal of a facility’s exemption
· Subpart F: Records requirements
The new GMPs are very similar in overall structure and intent to the traditional GMP rules you may be familiar with. However they are a little bit less specific in their nature, and leave more responsibility on the processor to determine what controls are necessary. They also have a very intentional added focus on prevention of allergen cross-contamination, and for good reason – allergen is the leading cause of recalls in the U.S. Certain non-binding provisions in the old GMPs, such as training, have been made binding – that is, they expect to see a robust training program in all facilities.
The food safety plan requirements (Subpart C, noted above), or “HARPC” (Hazard and Analysis and Risk-Based Preventive Controls) include:
1. Hazard Analysis
2. Preventive Controls
3. Supply Chain Program
4. Recall Plan
5. Procedures for monitoring
6. Corrective Action Procedures
7. Verification Procedures
The requirements of this section are very similar to traditional HACCP requirements. However there is a focus on overall “preventive controls” rather than just on CCPs; that is, every aspect of the plan that helps to control food safety hazards is important. This includes traditional GMPs as well as other programs like supplier control. As additional rules are published, they will give more clarification about certain specific requirements such as supply chain regulations, and how the Produce Safety rule will be applied. FDA also plans to issue guidance documents in the “near future”, which should help shed some additional light on how to implement these new rules.
There’s one more thing that’s important to note. Both the Preventive Controls rule and the Produce Safety rule will require that companies employ individuals who are “qualified” in these rules. That is, specific training is required! The courses are expected to include document templates which have been developed by a cross-functional entity that’s authorized by the FDA, so attendees will leave the training with some useful materials. DFA plans to offer both types of training sometime in the spring and early summer of 2016.
Who’s Covered by the Preventive Controls Rule?
In general, facilities which register with FDA under part 415 of the FD&C act (that is, food processors) must comply with the rule, unless specifically given an exemption. A few of the exemptions are based on specific food industry sectors such as meat processors or alcoholic beverage companies, which already have other regulations in place. However there are also some modified requirements for specific processes and industries, with examples given such as dehydrators, warehousing/storage, and yes – olive oil production may also be exempt. Required compliance dates are in place for the Preventive Controls rule, with separate compliance dates for the records requirement, and separate compliance dates for the supply chain requirements.
One of the most interesting changes that came out with this final version of the rule is that they re-defined farms, and as part of this re-defining process they created two new types of farm entities. Primary production farms are what many people would consider a “traditional” farm operation. Secondary Activities Farms give some flexibility by allowing some processes directly related to growing and harvesting, but perhaps not housed on-site at a farm, to be considered farm activities. However there is a key limitation to this, and it has to do with ownership. A business that carries out farming-related activities, but a majority of the services provided are for farms owned by other parties, will fall under this Preventive Controls rule and will likely be required to have a documented food safety program in place. If the majority of services are provided for the owner of the company, you’ll fall under the Produce Safety rule – which is a little bit different and the requirements can be described as more like traditional “GAP” programs.
Once you’ve determined if your operation is considered a farm or a food processor, the size of an operation is also key. With the FSMA rules there are deadlines for compliance, which depend largely on the size of an operation. The compliance deadlines for the Preventive Controls rule are summarized in table 53 of the rule, shown below.
What about Olive Oil?
As a member of the olive oil industry, I’m sure you have some questions about where you fall in terms of these requirements. Now that we’ve had time to read through the requirements, I can say with confidence that “it depends.” It’s a phrase that we find ourselves coming back to again and again in food safety, because it’s so often true. I do need to point out that the information provided below is intended to be informative but is not intended as legal guidance (after all, we aren’t lawyers!).
Fortunately, the rule does specifically call out virgin olive oil production as a farm activity in sections 117.5 (g)(3)(xii) and 117.5(h)(3)(v) when conducted at a facility that would be considered a farm. When production of olive oil is part of an operation that is defined as a Secondary Activities Farm it’s considered low risk. Do keep in mind, that if the majority of product produced by a company belongs to another entity and is not their own product, they are considered a food processor and not a farm. It seems that these companies will have to comply with the full Preventive Controls rule.
If your operation fits the “secondary activities farm” description, meaning it simply produces olive oil as a commodity and primarily handles your own product, then according to the sections 117.5 (g)(3)(xii) and 117.5(h)(3)(v) your olive oil operation may not have to comply with subpart C (the food safety plan/HARPC requirements) and subpart G (the supply chain requirements). Olive oil production operations that don’t have to comply with C and G, will still be required to comply with the updated cGMP requirements (“current good manufacturing requirements” - that’s in subpart B of the rule). However there is some flexibility in how the GMPs are applied to an operation.
The final consideration for olive oil producers is bottling operations. Bottling is clearly defined as a processing activity and therefore all of the preventive controls requirements apply. So if you’re bottling product on-site, you’ll probably have to implement the full requirements of the rule, based on my understanding of what the rule says. If someone else is bottling your product, and you’re receiving it back for sale, the lines are a little less clear and depend on where your product is sold and other factors.
At this point in time, both FDA and the food industry are still figuring out some of the details around how FSMA is going to be implemented and enforced.
Feel free to contact us at 916-561-5900 or email@example.com if you have any questions regarding the FSMA rules, or would like to set up a personalized webinar or an on-site training. You can also learn more about us and sign up for our newsletter at http://www.dfaofca.com/. Stay tuned as additional rules continue to be released by FDA over the next 8 months, and be sure to get training so you’re ready for compliance!
Spain Passes New Olive Oil Bottle Law
Spanish government has passed a law requiring restaurants to serve olive oil only in its original packaging to identify the brand. This new bill will start in 2014, requiring restaurants and bars to get rid of their generic glass bottles and replace them with labeled no-refill top bottles. This is done to prevent the refilling of these containers with lower quality olive oil and selling them at a higher price. This law goes in effect January 1st, but in order to run down the stock, businesses wont be required to begin using the original bottles until March. Read more --> Spanish News Today
What's New and Beneficial about Extra Virgin Olive Oil
"Anyone coming from the Mediterranean region of the world would tell you about the health benefits, as well as the wonderful flavor, of a good dose of olive oil on salads, pasta, fish and almost anything else. Fortunately, it is available throughout the year to satisfy taste buds and promote good health." - Read Full Post Here
Stolen Olive Oil Recovered In Spain
"Spanish authorities have recovered nearly 800 gallons of stolen olive oil, among other contraband, in the city of Castuera." - Full Story Here
New Global Olive Oil Production Estimates To Be 3.2 Million Tons in 2013/14
The IOC last month made a provisional production forecast of 3 million tons but said in its October newsletter, just published, that in light of new data received, world production in 2013/14 “looks set to top 3.2 million tons.” - Olive Oil Times
GLOBAL STANDARDS FOR EXTRA VIRGIN OLIVE OIL ARE WIDELY UNENFORCED, WEAKENING THE COMPETITIVE POSITION OF U.S. AND OTHER PREMIUM PRODUCERS, SAYS USITC
Although U.S. production of olive oil remains small on a global scale, the United States is among the nontraditional producing countries that are responding to higher global demand, and output has risen quickly in recent years. But recent investment in U.S. olive oil production has slowed in reaction to lower global prices following a succession of bumper crops in Spain, and because of concern among U.S. producers that their competitive position in the domestic market is threatened by a lack of regulatory oversight.
Current international standards for extra virgin olive oil allow a wide range of oil qualities to be marketed as extra virgin. In addition, the standards are widely unenforced. Mandatory testing with penalties for noncompliance exists only in Canada and the European Union. However, testing in the EU is only mandatory for a very small share of production (0.1 percent). Broad and unforced standards lead to adulterated and mislabeled products, weakening the competitiveness of high-quality producers, such as those in the United States, who try to differentiate their product based on quality.
EU government support programs contribute to high overall supplies of olive oil, reducing global olive oil prices. Many small growers in the EU rely on costly traditional methods of production and have costs that are at or above global prices. Because some of these producers would likely cease production in the absence of income support from the EU, the CAP has the indirect effect of increasing total global olive oil supply and reducing prices.
Olive oil marketers aim to differentiate their products by brand and level of quality, but price remains one of the most important factors in U.S. consumer purchasing decisions. This is due, in part, to a lack of consumer awareness of quality differences. U.S. consumers are generally unfamiliar with the range of olive oil grades and uses.
Broadly, two types of business models are employed to attract customers in the U.S. retail market: cost leadership or product differentiation. Firms that focus on cost leadership, such as large bottlers that blend oil produced in multiple countries, attract consumers mostly on price. On the other hand, smaller, vertically integrated firms produce a higher quality, more flavorful oil and try to differentiate their product based on quality.
The U.S. olive oil industry produces high-quality extra virgin olive oil, mostly through highly mechanized and intensively managed groves. U.S. farm level production costs for olive oil are competitive, but lack of scale and high capitals costs result in higher prices in the retail market.
Olive Oil: Conditions of Competition between U.S. and Major Foreign Supplier Industries (Inv. No. 332-537, USITC publication 4419, July 2013) is available on the USITC's Internet site at http://www.usitc.gov/publications/332/pub4419.pdf.
Read Full Article on www.usitc.gov
Claims of olive oil quality ripe for fraud
Olive Oil Fraud Rampant, Trade Agency Finds
"Something labeled "virgin" you'd expect to be authentic beyond reproach—"extra-virgin" even more so. But in the case of olive oil, say experts, it's quite a slippery slope."
"The evidence on olive oil has been piling up for several years. A 2011 study of extra virgin olive oil (EVOO) by the Olive Center at the University of California at Davis found that 73 percent of the five best-selling imported brands failed to meet the standards of taste and smell established for that grade of olive oil set by European regulators." - ABC NEWS