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Mitigating Risk through Food Packaging

By George G. Misko and Natalie E. Rainer, Keller and Heckman LLC

Historically, the main function of food packaging has been to safeguard food by providing a physical barrier to help maintain food and beverages in a sanitary condition. Over the years, advances in food packaging technology have resulted in packaging that provides additional protection and other benefits. These more recent innovations include susceptors to aid in the browning of foods cooked in microwave ovens, oxygen scavengers/emitters, ethylene scavengers, time-temperature sensors, and biosensors that can help to prolong shelf life and/or monitor the condition of food.  In fact, it is clear that over the past 100 years or more, packaging technology and food processing equipment has been a major contributor to the manner in which food products of all sorts safely reach the dinner tables of Americans and people throughout the world, while lessening the environmental footprint of this industry.  Indeed, even in these days of the coronavirus pandemic, the U.S. Food and Drug Administration (FDA) has stated that “[T]here is no evidence of food packaging being associated with the transmission of COVID-19.” (1)

(1) See the FDA information sheet, titled, “Shopping for Food During the COVID-19 Pandemic – Information for
Consumers.”

The U.S. and other jurisdictions around the world have implemented food packaging regulations to assure that packaging materials are safe for use and that no off-odors or tastes are imparted from the packaging to food or beverages. And as technological advances in food packaging provide improvements in food quality and safety, some of the regulations governing the composition and use of food packaging regulations have been changed to accommodate these advances. This article will focus on U.S. food laws governing food packaging materials and revisions to those laws necessitated by technological advances. First, though, we provide a brief description of the manner in which food packaging is regulated in the U.S. and the information that is required to assure the safety of food contact materials.

U.S. Food Packaging Laws

The history of formal regulation of food packaging in the U.S. began with the passage of the Food Additives Amendment of 1958.  Prior to 1958, customers sometimes insisted on being assured of a package’s safety and utility by asking to see some documentation from FDA or the U. S. Department of Agriculture (USDA) indicating that it had reviewed and found that the intended use of the materials would not adulterate food or, put another way, were safe for their intended use.  

The Food Additives Amendment of 1958 added, in part, a new section to the Federal Food, Drug, and Cosmetic Act (FD&C Act) that defined the term “food additive” as “any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food” unless that substance is Generally Recognized as Safe (GRAS) or subject to one of a number of exceptions or exclusions listed in the Act.”(2) As a result, all food contact substances that may reasonably be expected to migrate to food are regulated as food additives. Conversely, food packaging substances that are not reasonably expected to become components of food are not by definition “food additives” and may be used without prior authorization or clearance by FDA.

 (2) See Section 201(s) of the Federal Food, Drug, and Cosmetic Act.

Food contact substances (FCSs) that are considered food additives must be authorized for use in food packaging by FDA through a food additive regulation or a Food Contact Notification (FCN). The food additive petition process entails clearing food additives (including food packaging materials that meet the definition of a food additive) through a notice-and-comment rulemaking process. Information required to submit a food additive petition for packaging materials includes: the identity and composition of the substance of interest; a description of the manufacturing process; information on its intended use (such as food types, temperature conditions at the time of packaging and during use, and the expected duration of contact with food); and chemistry and toxicology data supporting the safety of that food additive for its intended use. The petition should also include test methods used to verify specifications for the raw materials and the finished products. Finally, the petitioner must include an environmental assessment to established whether the manufacture or use of the substance as intended will likely result in any undue impact that will require further study. Once a food additive is cleared through this process, FDA publishes a regulation, which can be relied upon by the petitioner as well as other manufacturers and users of the additive provided any limitations and specifications listed in the regulation are met. 

The FCN process largely supplanted the petitioning process with passage of the FDA Modernization Act of 1997. Data requirements for an FCN are about the same as those for a food additive petition with respect to the need to estimate dietary intake for an additive and establish safety through the provision of toxicity data adequate to support the estimated exposure. In addition, data identifying the FCS, its intended use manufacturing process and the like are very much required as in the petition process. The primary difference between the FCN and FAP process is that FCNs are proprietary, i.e., they can only be relied upon by the manufacturer of the FCS identified in the FCN and by its customers. Third parties who manufacture the same substance are required to submit their own FCN to be enabled to reach the same market. The other major difference is that  where it could take literally years for FDA to grant a petition, an FCN automatically becomes effective 120 days after it has been accepted for filing by the Agency, unless FDA objects in writing prior to the effective date.

Assuring Safety

FDA applies a tiered approach to the toxicity data needed to support safety of food-contact materials. That is, the higher the level of estimated dietary intake to a substance, the greater the toxicity data needed to support safety.  

Another important consideration with respect to safety is the statutory and regulatory requirement that food contact materials be manufactured in such a way as not to result in the adulteration of food, i.e., be of a purity suitable for the intended use, as  required by FDA’s Good Manufacturing Practices (GMP) regulation for food packaging materials. (3)

(3)  See Title 21 of the Code of Federal Regulations, Section 174.5. 

The suitable purity requirement dictates that FCSs may not impart anything to food that may cause it to be harmful or deleterious to health or result in an off-taste or -odor in food. To meet this requirement, the manufacturer must consider the safety of foreseeable impurities in the FCS, including residual monomers, starting reactants, catalysts, and reaction byproducts and degradation products. 

New Technologies

As new types of food packaging are developed based on technological advances, the safety of the materials used in these packages need to be evaluated. In some cases, revisions in food packaging regulations were made to assure the safety of the food in contact with new technology. We will examine some of these technologies and what new requirements, if any, were implemented to assure their safety.

Microwave Susceptors. The introduction of susceptors in microwave packaging resulted in higher cooking temperatures, which could be used to crisp and brown food by cooking it in a microwave oven. FDA food packaging regulations use the term “Conditions of Use” to describe the typical temperature conditions under which food products may be used in contact with packaging materials or articles intended to process or hold food. In April 2006, FDA expanded its list of Conditions of Use to include two additional categories. One of the new categories, Condition of Use J (“Cooking at temperatures exceeding 250°F”), is applicable to microwave heat susceptor materials. The following year, in December 2007, FDA updated its chemistry guidance for preparing FCN submissions. The new chemistry guidance includes specific protocols on testing for dual ovenable, microwaveable, and microwave heat susceptor materials.

Antimicrobial Agents. The safety of antimicrobials used in food packaging is regulated by FDA similar to other food additives; however, they may also require registration with the U.S. Environmental Protection Agency (EPA) under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Additionally, antimicrobials used in or on permanent or semi-permanent food contact surfaces, which are not intended to have an ongoing effect on the food contact surface, are regulated by FDA as food additives. If, however, the intended effect is ongoing, that is, intended to preserve the article from microbes or the protection of the user, EPA exercises jurisdiction over the use and food safety issue. 

In all cases, except those involving processed food, the antimicrobial used will be considered a pesticide for purposes of FIFRA and will require registration with EPA regardless of FDA’s jurisdiction over the matter. In addition, antimicrobials added to packaging materials with the expressed intent of migrating into the food to increase its shelf life by retarding spoilage may be considered food preservatives by FDA or USDA, if meat or poultry, and require labeling of the food product.   

Biobased and Biodegradable Plastics. As interest in sustainability has increased, the use of biobased and biodegradable plastics in food packaging is expanding. “Biobased” means related to or based out of natural, renewable, or living sources, while “biodegradable” means capable of being broken down naturally to basic elemental components (water, biomass, and gas) with the aid of microorganisms. “Biobased plastics” are plastics manufactured from renewable biomass, such as vegetable oil, cornstarch, pea starch, and microbiota. Biobased plastics can also be biodegradable.

While biobased plastics are required to comply with the same regulations with respect to food safety as fossil-based plastics, there are several regulatory issues that need to be considered for new biobased material or new applications for existing materials. These include determining the appropriate food simulants to be used to estimate the potential for migration and demonstrating that the substance is stable for its intended use. In addition, it may be necessary to consider the suitable purity of the finished product with respect to the potential presence of organic matter, such as cellular debris, and naturally occurring contaminants (e.g., mycotoxins and algal biotoxins). 

Recycled Materials. The growing interest in sustainability is also behind recent initiatives by a number of food companies to increase the use of recyclable packaging and the use of post-consumer recycled plastic content in food packaging. Recycled plastic in food packaging must meet the same safety standards as virgin plastic. 

Companies may independently evaluate the status and safety of a polymer produced through a recycling process. However, many companies will submit their determinations to FDA for review through a voluntary program. If FDA agrees with the company’s determination that a given recycling process is adequate to produce suitably pure recycled food-contact material, it will issue a no objection letter (NOL). To assist recyclers, FDA has issued guidance on recycled plastics for use in food packaging, which provides information on how to establish the safety of recycled polymers for food packaging. With respect to secondary (physical reprocessing) and tertiary recycling (regeneration of purified starting materials), FDA stresses the importance of demonstrating that possible contaminants from prior use of the plastic are sufficiently removed by the recycling process. To accomplish this, FDA provides specific recommendation on contaminant testing.

Conclusion

We have provided several examples of new innovations incorporated into food packaging. The use of antimicrobial is just one example of active and intelligent packaging, or packaging that interacts with food or its surroundings to prolong shelf life or monitor the condition of the food, slow the rate of oxidation, and prevent microbial attack. As advances in food packaging technology continue, further regulatory considerations may need to be addressed.

About the Authors:

George Misko is one of Keller and Heckman’s Food and Drug practice group leaders. Mr. Misko’s practice focuses on food and drug matters and environmental concerns, including pesticide regulation, right-to-know laws, and toxic substance control regulations. He has extensive experience counseling clients on regulatory requirements relating to chemical substances, plastics and food products in the U.S. and other jurisdictions, including Canada, the European Union, Latin America, and the Asia-Pacific region. He also represents trade associations, including acting as legal counsel to the Global Silicones Council.

Natalie Rainer practices in the area of food and drug law. She advises clients on regulatory requirements for foods, dietary supplements, cosmetics, and food and drug packaging in jurisdictions around the world, including North America, Latin America, Europe, Asia, and the Middle East. Ms. Rainer’s practice includes evaluating the regulatory status of food-contact materials, food additives, and color additives; advising companies on advertising and labeling requirements (including claim substantiation, nutrition labeling, menu labeling and environmental/green claims); and counseling clients on the Food Safety Modernization Act and its regulations.

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Safety – Blockchain: What is it and does it live up to the hype?

Written by Hillari Bynum
Originally published in Innovation
20 July 2019

 

Hand touching global network connection and data exchanges on sky sunset background. Technology and telecommunication concept.

 

Blockchain Fundamentals

 

The easiest way to understand blockchain technology is to think of it as an electronic notary. A notary protects the integrity of a document by verifying the signer’s identity, making sure they aren’t being forced to sign under duress or intimidation and making sure they’re aware of the contents of the document or transaction. So, when a document is notarized, you can feel confident the document is legitimate.

 

Blockchain serves a very similar function.

 

A blockchain is a growing list of records, called blocks, which are linked using cryptography. Each block contains a cryptographic hash of the previous block, a timestamp, and transaction data. By design, a blockchain is resistant to modification of the data. It is “an open, distributed ledger that can record transactions between two parties efficiently and in a verifiable and permanent way.”

 

Therefore, like a notary, Blockchain protects the integrity of the information stored within each block.

 

Why is Blockchain such a buzzword in the Food Industry?

 

During a foodborne illness outbreak, one of the biggest challenges is determining where the contaminated food originated from and where it was distributed/served/sold. There is not an easy way to track down this information; which makes managing a recall, or an outbreak, incredibly tricky, time-consuming, and dangerous.

 

Blockchain could change all of that.

 

Blockchain technology can keep a record of the entire supply chain. If Blockchain were implemented across the food industry, it would be possible to see everywhere a single piece of produce has been — from farm to plate. Consumers and food industry professionals alike would be able to see if a recall had impacted their produce or if it was from the same farm that is being investigated for a foodborne illness outbreak. Cool, right? It doesn’t stop there! This enhanced traceability could also help protect against food fraud by providing a verifiable record or every stage in the supply chain.

 

Okay great, let’s do it.

 

It isn’t that easy. There are a lot of very real obstacles in the way, and there is no easy solution.

 

Slow Supply Chain Adoption

 

In a dream world, when helpful technology is created, people rush to adopt it because they know it is valuable. In the world we actually live in, the reality is much different. Many key stages of the food supply chain operate with very low margins. Growers, packers, slaughterhouses, wholesalers, and harvest companies have very manual processes – and they don’t always have the capital to invest in technology. The other thing these companies are short on is time for training. Successful implementation of a new system requires time, money, and desire. When you’re operating with a shortage of time and money, desire is hard to come by as well. Transparency and traceability are popular ideas throughout the food industry, but when it comes time to actually turn that idea into reality, many companies have an “if it ain’t broke, don’t fix it”attitude.

 

The unfortunate reality is that people often pay the cost of food traceability at the early stage of the supply chain (growers, packers, processors) and the benefit is felt the strongest by those at the end of the supply chain (retailers and consumers). What this means is that we are asking the companies with the smallest margins to make the most significant investments – which they are often unwilling or unable to make. It is a fair point, outside of altruism, there is not a clearly defined business benefit to growers — so we are asking them to complicate their process, invest time and money, for little direct benefit.

 

This is particularly damaging because Blockchain won’t be revolutionary if it is only protecting part of the food supply chain. To be completely effective, every piece of the food supply chain needs to be on board.

 

 

Food Fraud is big business

 

Experts estimate that food fraud is now a $40 billion-dollar business. Unfortunately, the people committing food fraud are making a lot of money, and they are likely to be involved at some point in the supply chain. Blockchain and traceability technology threaten this business because of the technological ability to sound alarm bells and alert the world to food fraud. So, to protect their business model, these criminals will fight traceability implementation tooth and nail.

 

Too many independent systems

 

There are a lot of small-to-mid-sized companies offering traceability solutions, but unfortunately, these systems don’t always talk to each other. Blockchain success is heavily dependent on private tech companies being open to working together and sharing their data — which historically, they are not.

 

Traceability is different for different groups

 

Traceability varies by industry and product. For example:

 

  • Agriculture/Farming: Identification starts with the birth of livestock or planting and moves through the growth process, use of pesticides, nutritional records, vet records, and transportation records;
  • Food Processors: Identification starts at the source of each ingredient and follows through the processing, packaging, distribution, and transportation process;
  • Retail and Food Service: Identification starts with receiving receipts/invoices to identify the lot and batch information with regulations not requiring tracking “one-up” to the final consumer;
  • Transportation and Distribution: Commingling points of contact are vectors for the spread of disease. Waybills should contain source party and target party identification. Specific locations are needed for livestock in most countries. If products are disaggregated for smaller shipments, then records need to reflect lot/batch codes of the manufacturer or processor.

 

Different groups have different motivations, and it may be difficult for a system to accommodate the needs of each industry or product.

 

So, does it live up to the hype?

 

The short answer is maybe. Blockchain represents immense possibility, but it also comes with equally immense challenges. If the food industry doubles down on Blockchain and can secure engagement at every phase of the supply chain, the results would be revolutionary. However, if there is only partial adoption of traceability technology, it will be far less successful.

 

There is a reason to be optimistic, however! The FDA recently launched the New Era of Food Safety program that looks ready to move the food industry forward into new traceability technologies.