Gary Kestenbaum authored a valuable piece on Food Packaging Safety:

"Primary or “1st party” audits

Primary or first party internal audits are typically informal walkabouts, evaluations and observations executed by members of a facility internal safety or performance team. Team members inspect and assess food safety performance in production facilities or satellite locations against written corporate standards and procedures. The inspection concludes with a written summary of observations and required improvements linked to action items. Team representatives meet with Operations staff to discuss results and next steps.

Secondary or “2nd party” audits

Stakeholders use internal or external expert resources to formally audit (inspect and qualitatively grade) individual facilities (manufacturing, warehousing etc.) where food products and packaging components are converted, manufactured, stored and shipped. The criteria for inspection are typically composed of written, internal documents containing food safety requirements, procedures and expectations.

2nd party audits are semi-formal, but may be more challenging to the facility that 3rd party audits, particularly when the auditor is a Company expert having deep knowledge of the facility, operations and business objectives. This type of audit is performed with guidance and cross-conversations during the inspection. The inspection concludes with a summary of expectations, observations and conclusions, including a written list of non-conformances, omissions and needs for corrections, improvement and next steps, often including timing for re-inspection or remedial assistance.

Third Party Audits

Third-party food and packaging safety audits are performed for a variety of reasons, but for the purpose of this discussion, I will refer to a scored audit requested by a partner or member in a chain of supply with the specific intent to verify a vendor or supplier compliance with a specific food safety program. Again, typically, the audit criteria for success (performance requirements and expectations) are developed using current, written food safety standards influenced by industry best practices and related regulations.

Audits are usually most effective when performed by certified auditors with training or experience in the categories (food ingredients, food processing, packaging ingredient or components conversion, etc.) they audit. The auditor’s objective is to assess and evaluate the ability of the audited facility and overall organization to insure intake, handling, production and distribution of safe food and packaging to and through the supply chain and ultimately to consumers. The audit is intended to determine if appropriate industry-accepted written food safety program procedures are in place and, if so, that management and staff are applying those written procedures effectively and consistently in order to produce safe products. In other words, the auditor is looking for evidence that auditee’s written procedures and protocols are in place, being performed and properly documented. Auditees should expect trace, recall, non-conforming product or defect logs and related actions or follow ups to undergo auditor scrutiny for evidence of effectiveness and validation.

Auditees should be presented with or obtain, in advance, a written manual containing all program stipulations and expectations. Reference guides for most major food packaging safety programs, or “schemes”, as they are often referred, are available from either the organization itself or from third parties. These guides provide clarification, examples and general assistance to those unfamiliar with the specifics within the program or scheme.

Most branded programs and schemes connected to the quality and safety industry leaders are developed using a broad array of information including, but not limited to:

Latest global food and packaging material and component safety standards; Legal guidance and requirements; Documented best practices and processes; Observed safety risks identified by global experts and regulators; and Relevant data and related information from scientific-based global organizations. Some auditors will have deep familiarity with the industry they are auditing; others may have general familiarity with manufacturing, handling and storage facilities in general, but not specific, hand-on experience with the specific equipment, processes and methodologies used at your facility. Therefore, deeply experienced auditors may ask very specific questions about process safety. Others may ask the auditee representative to provide evidence as proof that policies, procedures and related, reasonable mitigations are in place and functioning, as written, against each connected requirement in the expectations manual.
Audits, depending upon the degree of difficulty and scope, are often bifurcated. Step 1 in the process is evaluation of the general organization, purpose and objectives, documents and related processes. Step 2 involves inspections of the building(s), processes, infrastructure, site and grounds.

Typical audits are both qualitative and quantitative (scored). The scoring process will be explained to the auditee and, often, the auditor will give the auditee a qualitative summary of deficiencies. The qualitative component of a 3rd party audit is intended to function as: Auditor’s expert and independent interpretation of the auditee’s understanding, execution and process effectiveness against each individual written requirements or expectations included in the specified, target food safety program or scheme. The quantitative component of a third party audit is intended to: Alphanumerically grade the execution, quality, performance, compliance, functionality and effectiveness of each aforementioned requirement or stipulation included in the specified, target food safety program or scheme.
Add or subtract points or grades from targeted totals within the process based on auditor’s observations of data and execution, as well as auditee explanations and evidence. Results for both components are determined based on the concept “if there is no visual, written or credible evidence or proof that the requirement or stipulation exists and is being performed, it didn’t happen or doesn’t exist.”

In other words, it is reasonable and expected for readers of an audit summary to easily conclude whether or not the auditee documents, maintains and effectively executes each requirement or expectation within the targeted food or packaging safety program and that adequate records and evidence exists to sustain proof of same.

Auditer and auditee details

Auditors may be counseled to limit the detail they provide to the auditee upon completion of the visit and discouraged from providing auditees with lengthy explanations on scoring rationale at the completion of the audit. The audit process is most likely to conclude fairly and accurately when all steps are completed. An auditor needs time and opportunity to review notes, consider all factors and then write an accurate report, which is submitted to a supervisor and reviewed again for accuracy, fairness and completeness. Typically, the auditing firm sends a copy of the report to the auditee and will reasonably consider comments from same relating to disagreements, discrepancies, omissions or misinterpretations. Auditing companies attempt to be fair and reasonable, but at times the auditor and the auditee may “agree to disagree” on performance against expectations.

To summarize, auditors are attempting to verify that the auditee:

Facility management understands the precepts and policies required by the targeted food safety program as described in the expectation manual; Has created and implemented procedures to address, control and mitigate risks connected to general food and packaging safety; Has documented and proven the use and effectiveness of those procedures; Has documented or proven employee performance and understanding of any and all procedures. Whether manufacturing or conversion takes place in a clean environment (injection stretch blow molding, for example) or in a sensorially displeasing environment (paper recycling and manufacturing, for example), the ultimate expectations are similar: demonstrate that raw materials, intermediates and finished products are being converted or manufactured in a controlled facility, using applicable, effective food safety process controls, that the general grounds and environment are free from contamination and vermin and that all mandated processes and controls required by law (and recognized industry guidance) are understood, practiced and documented.

Auditees should be able to demonstrate to an auditor how the processes in place protect all goods destined for consumer use are so that they are controlled and free from physical, chemical and biological hazards and contamination.

In the rare event that a major food safety breach is observed during the audit or that practices at the facility represent a clear and present danger to consumer and customers, the auditor may suspend the audit and report a summary of same to his supervisors and to the designated representative at the facility under inspection. In the event evidence demonstrates that auditee documentation or understanding is consistently insufficient or absent, auditor may logically propose suspension of the audit to a later date after auditee has been given time to comply.

I personally witnessed an audit wherein the auditee was downgraded for not maintaining written records demonstrating employee understanding of food safety protocols. The production supervisor argued that it was culturally offensive to employees to force them to take written safety comprehension tests in order to demonstrate use. Finally, the parties agreed that in this case, proof of employee comprehension and performance would be considered effective following oral discussion between employee and supervisor, followed by demonstrated execution of food safety procedures, summarized and documented in writing by the supervisor and placed in a file for auditor’s review. The takeaway is that professional auditors are trained and encouraged to dialogue with the auditee, giving them ample opportunity to explain how what they are doing does in fact comply with the spirit and intent of food and packaging safety program requirements."

Gary Kestenbaum has 40 years’ experience in the food and packaging industries, six as a supplier with National Starch, 18 as a product developer with General/Kraft Foods and 15 as a packaging engineer and developer with Kraft.

Courtesy of Gallagher Fluid Seals, here’s a guide to O-Ring materials, how they are used, and when to avoid using them:

Nitrile (Buna, HBR): A widely used, economical material that has strong wear resistance and mechanical properties. Temperature: -55 to 250 degrees Fahrenheit Applications: Petroleum based oils and fuels, dynamic applications Avoid: Break fluids and ozone Hydrogenated Nitrile (HNBR): Nitrile base with added chemical strength and resistance following hydrogenation.

Temperature: -50 to 300 degrees Fahrenheit Applications: Water and steam up to 300 degrees Fahrenheit, fuel systems, oil resistant and high abrasion applications Avoid: Strong acids and polar solvents such as ethers and ketones Polyacrylate (ACM): Widely used by auto makers in power steering and transmission systems.

Temperature: -15 to 350 degrees Fahrenheit Applications: Mineral oil, engines, gear boxes, power steering, transmissions Avoid: Cold temperatures, hot water, steam Ethylene-Propylene (EPDM): Strong ozone and chemical resistance

Temperature: -55 to 275 degrees Fahrenheit, 300 degrees Fahrenheit when used with peroxide curing agents Applications: Brake systems, glycol-based fluids, H20 steam Avoid: Mineral oil products and hydrocarbon fluids Chloroprene (Neoprene, CR): The first commercial synthetic rubber developed, chloroprene has good mechanical properties over a wide range of temperatures.

Temperature: -40 to 250 degrees Fahrenheit Applications: Refrigeration, due to its excellent ozone resistance, low-temp H20 Avoid: Esters, ketones and aromatic and chlorinated hydrocarbons. Butyl: An all-petroleum compound, butyl has low gas permeability and good resistance to sun exposure and ozone.

Temperature: -70 to 400 degrees Fahrenheit Applications: Life science and medical devices, FDA applications, numerous specialized compounds for specific material certifications Avoid: Highly abrasive applications and water and steam over 250 degrees Fahrenheit Fluorosilicone (FVMQ): Broad temperature performance and strong fuel and solvent resistance, but weak abrasion resistance due to high friction.

Temperature: -75 to 400 degrees Fahrenheit Applications: Aerospace, fuel and mineral oil Avoid: High temperature air, dynamic applications Flurocarbon (Vikton, FKM): The high fluorine levels in fluorocarbon rings give them excellent swelling and permeability resistance. They also feature high temperature and chemical resistance.

Temperature: -15 to 400 degrees Fahrenheit Applications: Broad chemical resistance, transmission and blended gasoline Avoid: Low temperatures, ketones and amines Tetrafluoroethylene-Propylene (AFLAS): Excellent chemical and temperature performance.

Temperature: 15 to 450 degrees Fahrenheit Applications: Aerospace, steam, hot water, oil fields Avoid: Chlorinated hydrocarbons, ketones, acetic acid Perfluoelastomer (FFKM): Of all elastomers, this one has the highest performing temperature and chemical properties, as well as low out-gassing and extractable properties.

Temperature: -15 to 600 degrees Fahrenheit Applications: Semiconductors, chemical processing, vacuum applications Avoid: Fluorinated solvents and perfluorinated lubricants If you have questions about O-Ring materials, contact Gallagher Fluid Seals, Inc. Our experts can answer any questions you might have about these small, yet crucial, sealing products.

While Melbourne, Fla.-based Palmas Printing certainly isn’t new to package printing, it is fairly new to printing on flexible film – and Jim Love, Palmas’ VP, has no issue admitting it.

“We’re not a new company, but we’ve basically made a transition from being a label printer to a flexible packager and we’ve managed to do it without going out of business,” he says.

But Love also admits that Palmas was “a hair away” from closing shop. And to truly understand how Palmas got to where it is at now, you’d need to know the company’s backstory. George Schmidt & Co. is a printing, converting and finishing firm that has been in business since 1874. One of the markets the company has excelled in is tobacco packaging and printing. When many of its large cigar clients began opening shop in Puerto Rico in the 1970s, George Schmidt & Co. opened Palmas Printing as a subsidiary in Juncos, Puerto Rico to better serve these clients. Palmas Printing originally consisted of a single gravure press focused on printing rolled cigar bands. As the business grew, Palmas added capacity and eventually expanded into pressure-sensitive labels.

“When flavors came out for cigars, the traditional brands went into line extensions and became different flavored versions of well-known cigars,” Love says. “That kind of killed gravure because the cylinder changes and the setup times and the runs all went another direction and we needed a more cost-effective way to do shorter runs. We got into flexo at that point.”

Things were going good for Palmas Printing. Love says the company owned about 95 percent of the mass market in the cigar industry. And then things changed in the late 2000s following the company’s move from Puerto Rico to its current location in Melbourne, Fla. With the proliferation of flavors in the cigar industry, metalized wrappers soon started to displace bands. Palmas didn’t have the right equipment to print on the unsupported film material.

“We very quickly decided that we had to spend a whole lot of money to re-tool and take advantage of the relationships that we’ve had for so many years with these tobacco companies,” Love says. “If we didn’t get into flexible packaging, we weren’t going to have a business.

“We started spending all of our money on new equipment. Right after that happened, in 2010, pouches began to cannibalize wrappers. That continues today – now wrappers are a much smaller part of our business and pouches are our primary business – and it’s growing. That’s required more equipment. Now, instead of just printing a cigar band and a film wrapper, we’re doing the film printing and the laminating and the forming of the pouch, including a zipper closure.”

Today, Palmas Printing only does flexographic printing. It operates five flexo presses and is capable of printing in up to 10 colors and up to 17 inches in web widths (31 inches with partners). While Love admits that he loved the high-quality and repeatability of gravure printing, it became non-competitive from a cost standpoint when Palmas was forced to transition into printing shorter runs. Flexo’s fast set up time and inexpensive operating costs – especially when it comes to short print runs – were the basis behind Palmas’ decision to adopt the technology.

This story originally appeared in Flexible Packaging.

Stuart Margolis, a financial expert in the printing industry, has a worthwhile piece in Printing News where he notes that, inherently, owners learn to watch out for signs of trouble before that can impact business and many times the school of hard knocks actually pays off.

"Constant control to correct financial trouble spots before they turn into a big mess is a common denominator. Keys to success seem to be: keeping an objective viewpoint, understanding the key indicators that trouble could be on the way, surrounding yourself with a loyal team that isn’t afraid to tell you the truth (good or bad), and having a commitment to accept the challenge to deal with the sea of changes to operations, technology and customers that are in front of you."

"As a successful leader you understand that when everything’s going great you must keep up the momentum and optimism but don’t let rose colored glasses blind you. To have success after weathering storms of recessions, technological overhauls, and resignation of key staff members is a great achievement. You believe in your product and so do your customers. Your business model is sound. You’re convinced that your business will succeed. You also realize that it’s important to regularly step back and take an objective look at how your business is doing financially."

"Otherwise, why would you keep trying so hard? Most successful business owners measure their accomplishments based on beating the competition by earning higher profits. It’s not that their money grubbers, it’s because their competitive and they want to win the race."

"We recommend taking a big picture strategic view quarterly. Successful owners follow suit by looking at performance, weaknesses and trouble areas as well as potential financial challenges. Look at your financial standing compared to previous quarters, for the same time frame year-to-year, to the profit leaders in the industry, and most importantly to your budget and expectation. Paying attention to how your sales, profit margins, growth and cost structure changed in those time frames will tell you a lot about where your business is headed financially."

"View your business as it is. Then, plan or reinvent it for what you want it to be. Don’t ignore the small stuff. Little “glitches” like exceeding costs on the cost sheet a few times, reducing customer markups, letting accounts slip in the aging cycle can all work against you to put you in a real jam. They add up. Be honest among your management team and hold each other collectively and individually accountable."

"Once you’ve finished your next plan, focus on accomplishing your goals and implementing the changes needed. Even little improvements like cleaning the floors, or contacting a certain customer that we’re waiting for their approval, staying on top of a customer accounts receivable balance and calling key customers to “check in” all add up to keeping your success alive and well."

The U.S. Environmental Protection Agency (EPA) finalized a rule to modernize Clean Water Act reporting for municipalities, industries, and other facilities. The final rule will require regulated entities and state and federal regulators to use existing, available information technology to electronically report data required by the National Pollutant Discharge Elimination System (NPDES) program instead of filing written paper reports.

EPA estimates that, once the rule is fully implemented, the 46 states and the Virgin Islands Territory that are authorized to administer the NPDES program will collectively save approximately $22.6 million each year as a result of switching from paper to electronic reporting. The final rule will make facility-specific information, such as inspection and enforcement history, pollutant monitoring results, and other data required by NPDES permits accessible to the public through EPA’s website.

“Electronic reporting will give the public full transparency into water pollution sources, save millions of dollars, and lead to better water quality in American communities,” said Cynthia Giles, assistant administrator for EPA’s Office of Enforcement and Compliance Assurance. “This rule will significantly reduce the burden and costs of paperwork, freeing up limited resources for states and other regulatory authorities to focus on the most serious water quality problems. After more than two years of working closely with states and a range of stakeholders, today we take a critical step to bring clean water protection into the modern age.”

“ECOS is pleased to see a rule move ahead that modernizes how businesses, states, and the federal government interface and share information in the clean water program,” said Alexandra Dapolito Dunn, Executive Director and General Counsel of the Environmental Council of the States. “Our focus going forward with EPA and the impacted regulated community will be on smooth implementation of this rule, and on developing flexible approaches when needed.”

The Clean Water Act requires that municipal, industrial or commercial facilities that discharge wastewater directly into waters of the United States obtain a permit. The NPDES program requires that permitted facilities monitor and report data on pollutant discharges and take other actions to ensure discharges do not affect human health or the environment. Currently, some facilities subject to these reporting requirements submit data in paper form to states and other regulatory authorities, where the information must be manually entered into data systems. Through the e-reporting rule, these facilities will electronically report data directly to the appropriate regulatory authority.

EPA proposed the e-reporting rule in July of 2013 with a public comment period. Since then, EPA has held over more than 70 technical and individual meetings with states to review the electronic reporting provisions and to identify any issues requiring resolution. In addition, EPA held over 50 webinars and meetings with over 1,200 stakeholders to discuss the rulemaking. EPA will continue collaborating with states as they enhance their electronic reporting capabilities to support the rule’s implementation. Over the next few months, EPA will schedule trainings and outreach webinar sessions for states and regulated entities to provide an overview of the final rule, and the next steps for implementing electronic reporting.

In response to state feedback, the final rule provides authorized NPDES programs with more flexibility for implementation, providing more time for the transition from paper to electronic reporting and more flexibility in how they can grant electronic reporting waivers to facilities. Most facilities subject to effluent monitoring reporting requirements will be required to start submitting data electronically one year following the effective date of the final rule. A second phase will incorporate electronic reporting for other Clean Water Act reports such as performance status reports for municipal urban stormwater programs, controls on industrial discharges to local sewage treatment plants, and sewer overflows. Also in response to comments and suggestions from states, EPA is providing states with more time to electronically collect, manage, and share this data – up to five years instead of two years as initially proposed.

This rulemaking is part of EPA’s Next Generation Compliance strategy, as well as the E-Enterprise for the Environment strategy with states and tribes, to take advantage of new tools and innovative approaches to increase compliance and reduce pollution. The shift toward electronic reporting in the NPDES program and others will help make environmental reporting more accurate, complete, and efficient. It will also help EPA and co-regulators better manage information, and improve effectiveness and transparency.

EPA expects to publish the final rule in the Federal Register in October, 2015. The final rule will be effective 60 days following this publication.

Clever graphics on stand-up pouches—along with traditional characters and color schemes—are helping to sell Halloween candy to a most-receptive audience. Americans are expected to spend a whopping $2.6 billion (with a B!) on candy for this year’s holiday, according to the National Confectioners Assn.

A recent visit to a local Walmart superstore unearthed a bevy of bags and boxes—adorned with witches, zombies and monsters, oh my!—that are a real treat for the gremlins ringing doorbells on Saturday.

Among the notable Halloween candy packaging trends:

• The majority of secondary packages are flexible bags or pouches—with more stand-up pouches than I ever remember seeing before (gotta love that vertical display!). There were only a couple cartons and other rigid packages in an entire aisle of offerings. (As you may know, flexible packaging can be difficult to photograph sometimes. My apologies if the images aren’t the best.)
• A lot of clear windows show the inner beauty of the primary packs, many of which have matching or complementary graphics.
• Faces looking at you make you look at them. Eyes, in particular, draw consumers’ attention to many of these products.
• Traditional orange and black colors are prevalent—making these packages fade a bit in a sea of sameness.
• A handful of products created “fall” graphics rather than Halloween-specific images, perhaps to help extend the selling period past Oct. 31.
• All of the Halloween candy in the aisle at this Walmart store was shipped in retail-ready displays (see below). This makes the shelves easy to stock and presents an organized look, but the edges and bottoms of the cases hid a bit too much of the bags, pouches and cartons—taking away from their shelf impact. Also, removing the package wasn’t always easy.

Demand for converted flexible packaging in the US is projected to increase 3.3 percent annually to $20.7 billion in 2019.

Although advances will decelerate from the pace of the past decade, converted flexible packaging will remain a growth area in both food and nonfood applications due to the inherent cost and performance advantages of lightweight bags and pouches. Moreover, converted flexible packaging’s source reduction, space savings, and lower production and transportation costs will be increasingly advantageous in light of the growing importance among major retailers and packaged goods firms of supply chain sustainability as a competitive advantage.

All of these factors will drive further conversions from rigid to flexible formats. These and other trends are presented in Converted Flexible Packaging, a new study from The Freedonia Group, Inc., a Cleveland-based industry market research firm.

Pouches will experience above average gains, reflecting continued opportunities in both food and nonfood segments and for new conversions from rigid packaging. Analyst Esther Palevsky notes, “Growth will benefit from the increased prevalence of value-added features, such as spouts and fitments, as well as the development of newer stand-up pouch designs that can contain heavier weight contents.”

Bag demand will rise more slowly due to the maturity of a number of applications, competition from pouches, and, to some degree, rigid packaging such as clamshells and blister packaging. Overall advances will be helped by growth in food production, an expanding elderly population, and the importance of bags for bulk and other larger-sized packages in such markets as pet food, chemicals, building materials, and agricultural and horticultural products.

The Asian label and product decoration market, and the parallel release liner market, are the subject of two new surveys this year from AWA Alexander Watson Associates. The developing profile of this major regional market is a current major focus around the world, as third quarter Chinese market growth, at 6.9%, continues to slow.

AWA Asian Labeling and Product Decoration Market Study 2015 provides detailed analysis of markets, materials, and technologies – pressure-sensitive/self-adhesive, glue applied, sleeving, and in-mold – and key trends and drivers. It also delivers informed market forecasts to 2019.

AWA Asian Release Liner Market Study 2015 analyses the same region in the broader context of release liner, which spans many more market segments. It Assesses market size, growth, material trends and the changing market structure across all the main segments, from pressure-sensitive/self-adhesive labels through tapes, hygiene, medical, graphics, industrial, and other applications.

These two new studies will shortly be complemented with a third report with an Asian focus, AWA Asian Extrusion Coated Materials Market 2015. Full details are available on the AWA Alexander Watson Associates website, www.awa-bv.com.

The worldwide market for kitchen and bathroom linen registered an average annual growth rate (AAGR) of 3.7% during 2008-2014. Till 2019-end, the market is forecast to grow at an average rate of 1.0% per year.

Currently, kitchen and toilet linen of cotton terry towelling capture сlose to 83.5% of the total demand, whereas the remaining share is distributed amid other kitchen and toilet linen of cotton (8.8%), kitchen and toilet linen of man-made fibers (just over 6%) and kitchen and toilet linen of other materials (1.7%).

China, Turkey, Japan, the UK and the US are the dominant kitchen and toilet linen markets, whilst such nations as Poland, the Philippines, Bolivia, Jordan and Morocco are expected to post the highest growth at 10.3%, 9.5%, 8.3%, 5.5% and 5.5% per annum, respectively, over the forecasted period.

source: Global Research and Data Services

With the White House set to make a determination on the U.S. Environmental Protection Agency’s (EPA) ozone proposal by October 1, the National Association of Manufacturers (NAM) is launching its latest major ad buy. This ad highlights how air pollution from abroad is offsetting the substantial air quality gains made across the United States.

The ad buy, the latest in a multimillion-dollar television campaign by the NAM, will first air in Washington, D.C., Virginia and New Mexico on Wednesday, September 9, and will continue through October 1 in several other states. “It makes no sense to punish manufacturers in the United States for China’s failure to curb air pollution,” said NAM President and CEO Jay Timmons. “We are part of the solution.”

Communities throughout the United States are pushing hard to reduce ozone levels—and it’s working. According to the EPA, ground-level ozone is down nearly 20 percent over the past decade and by 33 percent since 1980. Out west, states have reduced their ozone production by 21 percent in recent years. Despite these substantial improvements, a recent study by researchers affiliated with NASA concluded that air pollution from China is offsetting emission-reduction measures in the United States.

The National Association of Manufacturers (NAM) is the largest manufacturing association in the United States, representing small and large manufacturers in every industrial sector and in all 50 states. Manufacturing employs more than 14 million men and women, contributes $2.09 trillion to the U.S. economy annually, has the largest economic impact of any major sector and accounts for more than three-quarters of private-sector research and development.