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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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California Hemp Farming and Products Start to Take Shape

Written By Robert W. Selna,
Founder Selna Partners Law Firm

Interview with Robert Selna as a webinar.
Listen to the interview with Robert Selna as a podcast episode through Spotify.
Gloved hand holding leaves of five leaved plant, potentially hemp or cannabis.

California hemp cultivation registrations skyrocketed in 2019 and are expected to increase further this year due to federal hemp decriminalization and a perceived demand for hemp-derived CBD and other hemp products. A mature statewide hemp industry is a ways off however, due to unfinished regulations and the on-going effort to overcome a federal ban on food and beverages infused with hemp-derived CBD.  

“Ninety-nine percent of the hemp being grown in California right now is for CBD and, at the moment, the only legal hemp CBD products are topicals and smokable hemp,” said Brian Webster, Founder of CA-Hemp, an advocacy group that supports the growth of the hemp industry. “There needs to be an expansion of the topical and smokable products while the feds and the state issues around hemp CBD in food and beverages get worked out.” 

Hemp is defined as cannabis with extremely low concentrations of THC (not more than 0.3 percent on a dry weight basis). The Food and Drug Administration (FDA) prohibits CBD in food, beverages and cosmetics, regardless of whether the CBD is derived from cannabis that includes THC (the psychoactive constituent of cannabis) or from hemp.

CBD, short for cannabidiol, is a chemical compound from the Cannabis sativa (L.) plant that is widely accepted as exhibiting therapeutic properties, including anti-anxiety and pain-reduction effects. Unlike THC (short of tetrahydrocannabinol), CBD is not psychoactive. 

The U.S. Department of Agriculture (USDA) currently is reviewing public comments submitted in response to its October 2019 draft interim rule for domestic hemp production. The interim rule, which, despite its singular name includes scores of regulations, is a key step to implementing the 2018 Farm Bill. The Farm Bill legalized hemp nationwide after it had been criminalized by Congress in the early 1900s along with marijuana.

The 2018 Farm Bill left it up to states to decide whether to legalize hemp farming within their state’s borders, but required that, at a minimum, cultivated hemp could be freely shipped across all state lines. States that want to permit hemp cultivation either must adopt the federal regulations, or create their own that are consistent with the federal regs. The USDA’s publishing of the first draft of the interim rule has allowed states, including California, to start writing their regulations. 

Federal and State Laws

Outline of west coast states with California highlighted with image of hemp or cannabis filling its shape.

In 2019, as California’s fledgling hemp farmers waited for the federal interim rule to be published, they closely monitored two bills that state legislators introduced to take advantage of a vast new hemp business opportunity created by the 2018 Farm Bill. As the legislative session came to a close last year, results on the bills were mixed.

In mid-October, Governor Gavin Newsom approved SB 153, which provides the funding and timetable for California to draft a state hemp cultivation plan that conforms with the USDA interim rule. That work has started, but can’t be completed until the feds release their final draft.  

In contrast, state lawmakers failed to decide on AB 228, which would have legalized the statewide manufacture and sale of food, beverages and cosmetics that include hemp-derived CBD. The bill died in the Senate Appropriations Committee without a vote.

Following the lead of a handful of other states, including Colorado and Oregon, California Assemblymember Cecilia Aguiar-Curry (D-Winters) tried to address the federal CBD disconnect through AB 228. AB 228 contradicted the FDA, which deems products with CBD as “adulterated,” and prohibits them from being introduced into interstate commerce.

The FDA’s position is based on its decision to approve CBD as an active ingredient in the pharmaceutical drug Epidiolex, which treats a rare form of epilepsy. In turn, the FDA deems CBD to be like all other active drug ingredients, which may not be added to food and dietary supplements. 

Despite seemingly broad support, AB 228 did not make it out of committee by the end of the 2019 legislative session. Aguiar-Curry brought back a new version of AB 228 in January 2020 and hemp industry advocates had hoped the bill would be approved by late March. 

An early 2020 approval timetable proved unrealistic as advocates say that the Governor’s office and legislators still need more education about hemp, a crop that was ubiquitous from the founding of the Nation to the early 1900s, but that had been illegal for more about a century after being lumped together with marijuana. 

Thus far, the California Department of Public Health (CDPH) has followed the FDA’s restrictions on hemp-derived CBD. Meanwhile, one can find hemp-derived CBD wellness products in small health food stores, as well as large chain supermarkets, which has caused confusion among consumers. As noted by CA-Hemp’s Brian Webster, most of the hemp CBD products on those shelves are lotions, creams and other topicals — a type of product the FDA has not regulated.  

The FDA and CDPH prohibition are seen by many as inconsistent with the spirit of the 2018 Farm Bill, which approved the cultivation and sale of hemp, as well as the interstate commercial transfers of hemp and hemp products, including hemp-derived CBD. However, the Farm Bill did explicitly confirm the FDA’s authority to regulate hemp-derivatives in food and beverages. 

Representatives in Congress are starting to awaken to issues surrounding the FDA’s CBD prohibition. Senate Majority Leader Mitch McConnell has taken baby steps to resolve the problem. In mid-September, McConnell introduced a bill that could result in the FDA adopting a more lenient framework for hemp-derived CBD products. Specifically, the legislation directs the FDA to issue “an enforcement discretion policy” that would give the agency latitude and possibly lead to recognition that CBD products are safe.

Industry Growth 

Chart showing change in California Hemp Growers registered with the USDA from 74 in June 2019 to 558 in February of 2020.

Legislative hiccups and regulatory confusion aside, the California hemp industry is gaining momentum. Q4 statistics from the California Department of Food and Agriculture show that the number of registered hemp growers in California increased from 74 in June 2019 to 558 as of February 4, 2020. In addition, there are now at least 1,165 registered hemp cultivation sites and 38,464 acres associated with growers and seed breeders.

Under the 2018 Farm Bill, counties may only allow limited cultivation pilot programs until the USDA confirms that their state’s hemp plan conforms with federal rules. However, until the USDA’s interim rule issuance on Oct. 29, there was a chicken-and-egg problem. California and other states struggled to draft federally compliant hemp plans not knowing exactly what to expect in the interim rule. As a result, at least half of California countries have temporary bans or restrictions on hemp cultivation.

The federal interim rule clarifies states’ hemp regulation responsibilities, including practices for record keeping, methods for testing hemp to ensure that it is below the legal THC limit, and plans for the proper disposal of non-compliant hemp. In addition, the interim rule makes it clear that states and Native American tribes may not prohibit the interstate transport of hemp that has been legally grown under federal and state laws.

California is said to now be working on its hemp conformance plan. SB 153 aids that effort by adding testing, enforcement, and other administrative provisions and providing a deadline for completing a federal hemp conformance plan as May 1, 2020.

California’s nascent hemp industry is incrementally taking shape. 2020 promises to be a big year as federal and state hemp regulations are finalized and the State Legislature debates legalizing hemp-derived CBD products. 

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Ethics – Reclaiming lost calories: Tweaking photosynthesis boosts crop yields

Written by: Amanda Cavanagh
Postdoctoral Research Associate at the Carl R. Woese Institute for Genomic Biology, University of Illinois at Urbana-Champaign
Originally published in The Conversation
3 January 2019

What if your ability to feed yourself was dependent on a process that made a mistake 20 percent of the time?

We face this situation every day. That’s because the plants that produce the food we eat evolved to solve a chemistry problem that arose billions of years ago. Plants evolved to use carbon dioxide to make our food and the oxygen we breathe – a process called photosynthesis. But they grew so well and produced so much oxygen that this gas began to dominate the atmosphere. To plants, carbon dioxide and oxygen look very similar, and sometimes, plants use an oxygen instead of carbon dioxide. When this happens, toxic compounds are created, which lowers crop yields and costs us 148 trillion calories per year in unrealized wheat and soybean yield – or enough calories to feed an additional 200 million people for a whole year.

Amanda Cavanagh tests modified tobacco plants in a specialized greenhouse to select ones with genetic designs that boost the yield of key food crops. Claire Benjamin/RIPE Project, CC BY-ND

Improving crop yields to grow more food on less land is not a new challenge. But as the global population grows and diets change, the issue is becoming more urgent. It seems likely that we will have to increase food production by between 25 and 70 percent by 2050 to have an adequate supply of food.

As a plant biochemist, I have been fascinated by photosynthesis for my whole career, because we owe our entire existence to this single process. My own interest in agricultural research was spurred by this challenge: Plants feed people, and we need to quickly develop solutions to feed more people.

Supercharging photosynthesis to grow more food

It can take decades for agricultural innovations such as improved seeds to reach growers’ fields, whether they are created via genetic approaches or traditional breeding. The high-yielding crop varieties that were bred during the first green revolution helped prevent food shortages in the 1960s by increasing the proportion of grain-to-plant biomass. It’s the grain that contains most of the plant’s consumable calories, so having more grain instead of straw means more food. But most crops are now so improved that they are close to their theoretical limit.

I work on an international project called Realizing Increased Photosynthetic Efficiency (RIPE), which takes another approach. We are boosting harvests by increasing the efficiency of photosynthesis – the solar-powered process that plants use to turn carbon dioxide and water into greater crop yields. In our most recent publication, we show one way to increase crop yield by up to 40 percent by rerouting a series of chemical reactions common to most of our staple food crops.

Photorespiration costs a lot of energy

In the process of photosynthesis, carbon dioxide and water are transformed into sugars and oxygen. Sunlight powers this chemical reaction. BlueRingMedia/Shutterstock.com

Two-thirds of the calories we consume across the globe come directly or indirectly from just four crops: rice, wheat, soybean and maize. Of these, the first three are hindered by a photosynthetic glitch. Typically the enzyme that captures carbon dioxide from the atmosphere, called Rubisco, converts carbon dioxide into sugar and energy. But in one out of every five chemical reactions, Rubisco makes a mistake. The enzyme grabs an oxygen molecule instead. Rather than producing sugars and energy, the chemical reaction yields glycolate and ammonia, which are toxic to plants. To deal with this problem, plants have evolved an energy-expensive process called photorespiration that recycles these toxic compounds. But toxin recycling requires so much energy that the plant produces less food.

Photorespiration uses so much energy that some plants, like maize, as well as photosynthetic bacteria and algae, have evolved mechanisms to prevent Rubisco’s exposure to oxygen. Other organisms, like bacteria, have evolved more efficient ways to remove these toxins.

These natural solutions have inspired many researchers to try to tweak photorespiration to improve crop yields. Some of the more efficient naturally occurring recycling pathways have been genetically engineered in other plants to improve growth and photosynthesis in greenhouse and laboratory conditions. Another strategy has been to modify natural photorespiration and speed up the recycling.

Chemical detour improves crop yield

The red car represents unmodified plants who use a circuitous and energy-expensive process called photorespiration that costs yield potential. The blue car represents plants engineered with an alternate route to shortcut photorespiration, enabling these plants to save fuel and reinvest their energy to boost productivity by as much as 40 percent. RIPE, CC BY-SA

These direct manipulations of photorespiration are crucial targets for future crop improvement. Increased atmospheric carbon dioxide from fossil fuel consumption boosts photosynthesis, allowing the plant to use more carbon. You might assume that that this will solve the oxygen-grabbing mistake. But, higher temperatures promote the formation of toxic compounds through photorespiration. Even if carbon dioxide levels more than double, we expect harvest yield losses of 18 percent because of the almost 4 degrees Celsius temperature increase that will accompany them. We cannot rely on increasing levels of carbon dioxide to grow all the food we will need by 2050.

I worked with Paul South, a research molecular biologist with the U.S. Department of Agriculture, Agricultural Research Service and professor Don Ort, who is a biologist specializing in crop science at the University of Illinois, to explore whether modifying the chemical reactions of photorespiration might boost crop yields. One element that makes recycling the toxin glycolate so inefficient is that it moves through three compartments inside the plant cell. That’s like taking an aluminum can into three separate recycling plants. We engineered three new shortcuts that could recycle the compound in one location. We also stopped the natural process from occurring.

Four unmodified plants (left) grow beside four plants (right) engineered with alternate routes to shortcut photorespiration. The modified plants are able to reinvest their energy and resources to boost productivity by 40 percent. Claire Benjamin/RIPE Project, CC BY-ND

Designed in silico; tested in soil

Agricultural research innovations can be rapidly tested in a model species. Tobacco is well-suited for this since it is easy to genetically engineer and grow in the field. The other advantage of tobacco is that it has a short life cycle, produces a lot of seed and develops a leafy canopy similar to other field crops so we can measure the impact of our genetic alterations in a short time span. We can then determine whether these modifications in tobacco can be translated into our desired food crops.

Over two years of field trials, scientists Donald Ort (right), Paul South (center) and Amanda Cavanagh (left) found tobacco plants engineered to modify photorespiration are more productive in real-world field conditions. Now they are translating this technology hoping to boost the yield of key food crops, including soybeans, rice, cowpeas and cassava. Claire Benjamin/RIPE Project, CC BY-ND

We engineered and tested 1,200 tobacco plants with unique sets of genes to find the genetic combination that recycled glycolate most efficiently. Then we starved these modified plants of carbon dioxide. This triggered the formation of the toxin glycolate. Then we identified which plants grew best – these have the combination of genes that recycled the toxin most efficiently. Over the next two years, we further tested these plants in real-world agricultural conditions. Plants with the best combination of genes flowered about a week earlier, grew taller and were about 40 percent larger than unmodified plants.

Having shown proof of concept in tobacco, we are beginning to test these designs in food crops: soybean, cowpea, rice, potato, tomato and eggplant. Soon, we will have a better idea of how much we can increase the yield of these crops with our modifications.

Once we demonstrate that our discovery can be translated into food crops, the Food and Drug Administration and the USDA will rigorously test these modified plants to make sure they are safe for human consumption and pose no risk to the environment. 

Such testing can cost as much as US$150 million and take more than 10 years.

Since the process of photorespiration is common across plant species, we are optimistic that our strategy will increase crop yields by close to 40 percent and help find a way to grow more food on less land to be able to feed a hungry global population by 2050.