Southern Region Meeting: February 24-26, 2020

KTL is looking forward to seeing many NACD member companies at the NACD Southern Region Meeting in Savannah, GA February 24-26. It’s always such a great time to gain great insights from the NACD speakers, touch base with you on the latest happenings in your organization, and continue our conversations about your business and compliance needs.

Jake Taylor, KTL’s Responsible Distribution Adviser, will be available throughout the meeting to talk more about how KTL can help chemical distributors more effectively manage management system requirements (e.g., Responsible Distribution, ISO 9001) and ongoing EHS&S and food safety compliance obligations.

MEETING DETAILS

Spring Regulatory & Responsible Distribution Workshop: March 10-12, 2020

Plus, save the date for the NACD Spring Regulatory & Responsible Distribution Workshop this March in Long Beach, CA. The 2020 Regulatory Workshop focuses on International Trade for Chemical Distributors on March 10.

Attention turns to Responsible Distribution March 11-12. There are many great sessions planned for new and experienced NACD members, including KTL’s interactive session on Thursday, March 12 from 9:15-10:15: Digging Up the Roots! Root Cause Analysis Review and Exercise. Jake Taylor will be guiding participants through properly identifying root causes using real-world examples from 6th cycle non-conformance findings.

WORKSHOP DETAILS

Kestrel Tellevate is expanding our international resources with the addition of Consultant Emily Watt. Emily has in-depth knowledge of and experience as a Project Manager, working with federal contracting regulations and requirements. As a Consultant with international experience across multiple sectors, Emily will be working with KTL’s multinational clients and government agencies to provide EHS compliance and sustainability support.

Emily has worked on implementing projects for the U.S. Forest Service (USFS), U.S. Agency for International Development (USAID), U.S. Department of Agriculture (USDA) Agricultural Research Service (ARS), Office of Cooperative Threat Reduction (CTR) Chemical Security Program, and U.S. Department of State International Visitor Leadership Program (IVLP). Her primary countries of experience include Nigeria, Zimbabwe, Vietnam, Iraq, Turkey, Brazil, Malawi, South Korea, and India.

Read Emily’s complete bio for more information.

For the ninth consecutive year, Fall Protection – General Requirements (1926.501) has topped OSHA’s Top 10 Most Cited Violations list. The complete list for fiscal year 2019 includes:

1. Fall Protection – 1926.501
2. Hazard Communication – 1910.1200
3. Scaffolding – 1926.451
4. Lockout/Tagout – 1910.147
5. Respiratory Protection – 1910.134
6. Ladders – 1926.1053
7. Powered Industrial Trucks – 1910.178
8. Fall Protection – Training Requirements – 1926.503
9. Machine Guarding – 1910.212
10. Personal Protective and Life-Saving Equipment – Eye & Face Protection – 1926.102

In this article with Safety+Health, Deputy Director of OSHA’s Directorate of Enforcement Programs Patrick Kapust said, “These are common violations that we’re finding – they’ve been in place for a lot of years. The answers are out there, and employers shouldn’t feel like these are very complex issues.”

He further explains in the interview that the top 10 violations remain largely the same (with some variation in order) because employers don’t aggressively target these hazards in the workplace, despite OSHA’s resources. Falls remain the top cited hazard because they result in significant injuries and deaths.

That being said, falls, as well as the other top safety areas on the list, are easily preventable with the right training and commitment. Kapust suggests that the top 10 cited hazards are a good place to start when evaluating your workplace hazards. From OSHA’s perspective, targeted enforcement and outreach are two critical tools in getting employers to identify and correct hazards in the workplace. H&S professionals are encouraged to continue developing and promoting strong safety and health programs, as well as educating and training workers in safety awareness.

Read the entire Safety+Health article and interview with Kapust.

One of the real joys this holiday season is the opportunity
for all of us at Kestrel Tellevate LLC to say thank you
and to wish you the very best for the new year.

The Environmental Protection Agency’s (EPA) Risk Management Program (RMP) Rule requires facilities storing specific chemicals above certain threshold amounts to develop risk management programs to prevent and mitigate accidents that could release those chemicals into the environment. Just what the RMP rule entails has been the subject of debate since EPA first proposed the RMP Amendments in 2016. Rules related to RMP requirements have been published, petitioned, delayed, vacated, reissued, and reconsidered. As the most recent action in the ongoing RMP saga, EPA Administrator Andrew Wheeler signed the RMP Reconsideration Rule on November 21, 2019.

Reconsideration Rule

According to EPA Administrator Wheeler, the intent of the RMP Reconsideration Rule is to promote “improved coordination between chemical facilities and emergency responders, reduce unnecessary regulatory burdens, and address security risks associated with previous amendments to the RMP rule.”

What does that entail? In the final Reconsideration Rule, many of the major provisions that were added in the RMP Amendments Rule are rescinded, including the following requirements to:

• Hire a third-party to conduct a compliance audit after an RMP reportable accident. EPA retains the right to still require a third-party audit, when appropriate.
• Conduct a Safer Technologies and Alternatives Analysis (STAA). Again, this can still be required by EPA but is already encouraged under the rule’s existing Process Hazard Analysis (PHA) provisions.
• Conduct and document a root cause analysis after an RMP reportable accident/near miss, in efforts to maintain consistency with the OSHA Process Safety Management (PSM) standard.
• Make very broadly defined information available by facility to the public upon request to alleviate potential security/terrorism threats.

A number of other requirements, particularly as it relates to local emergency coordination and training exercises have been retained and/or modified, as follows:

Retained

• Requirements that facilities must coordinate annually and document coordination with local response organizations.
• Annual notification drills to confirm that emergency contact information is accurate.
• Requirement to perform field and tabletop exercises as a way to train facility personnel and local responders.
• Frequency of 3-year tabletop exercises to ensure regular emergency training is conducted.

Modified

• Provision to reduce potential security risks associated with avoiding the open-ended information disclosure provision.
• Frequency of field exercises by removing the ten-year minimum requirement to reduce burden on local emergency responders.
• Scope and documentation provisions for field and tabletop exercises to reduce burden.
• Requirement to hold a public meeting after an incident that has offsite impacts vs. releases with only onsite impacts.

The EPA RMP Website provides additional information and resources, as well as a copy of the complete RMP Reconsideration Rule and the updated requirements.

Risk-Based Approach

According to the EPA RMP Reconsideration Final Rule Fact Sheet, the final rule retains the prevention provisions that have resulted in the trend of fewer significant chemical accidents, which have declined more than 50% since RMP was first published in 1999. With the RMP Reconsideration Rule, EPA’s intent  is to take a more risk-based approach that focuses on the highest risk facilities (i.e., the less than 2% of RMP facilities reporting multiple releases), as opposed to the 90+% of RMP facilities who reported no accidents from 2007-2016.

Industry Reaction

RMP regulates approximately 12,500 facilities, including agricultural supply distributors, waste/wastewater treatment facilities, chemical manufacturers and distributors, food and beverage manufacturers, chemical warehouses, oil refineries and other chemical facilities. As a whole, industry has commended EPA for taking a more risk-based approach to RMP that reduces the regulatory burden on industry:

• “The RMP program has been working very well. The data clearly shows a continuous reduction in accidents of regulated facilities. It is important for EPA to focus on compliance assistance efforts and promoting enhanced coordination between RMP facilities and local first responders.” Richard Gupton, Senior Vice President of Public Policy and Counsel, Agricultural Retailers Association (ARA)
• “SOCMA and its members have been actively engaged in the reconsideration of the 2017 RMP Amendments and has been supportive of the Agency’s efforts to delay implementation of the prior rule while it conducted reconsideration proceedings. This final rule will provide much-needed certainty at facilities seeking to understand and achieve their RMP compliance obligations.” Robert Helminiak, Vice President of Legal and Government Relations, Society of Chemical Manufacturers and Affiliates (SOCMA)
• “We commend the EPA for developing a rule that reflects the extensive feedback the agency received through a comprehensive and thoughtful process to seek public input. The agency wisely incorporated the recommendation to strike the right balance of sharing vital safety information with emergency responders and protecting sensitive security information. EPA also followed the recommendation to utilize the EPA’s latest data to identify areas where more focused compliance assistance is needed to help facilities further reduce the number of reportable safety incidents.” Mike, Walls, Vice President of Regulatory and Technical Affairs, American Chemical Council (ACC)
• “NACD commends EPA for taking our recommended changes to the 2017 rule seriously and for instead pursuing a commonsense approach that improves facility safety without hamstringing businesses with burdensome requirements that have no proven benefit.” Jennifer Gibson, Vice President of Regulatory Affairs, National Association of Chemical Distributors (NACD)

Implications/What’s Next?

As the regulatory history with the RMP Rule demonstrates, it remains important for impacted companies to stay on top of the requirements, coordinate efforts with local emergency responders, and plan accordingly. For companies impacted by the RMP Reconsideration Rule, it is important to:

• Understand the hazards posed by chemicals at the facility
• Assess the impacts of a potential release
• Design and maintain a safe facility to prevent accidental releases
• Coordinate with local emergency responders
• Minimize the consequences of accidental releases that do occur

Kestrel Tellevate LLC (KTL) has experience working with a broad cross-section of industries impacted by RMP, particularly chemical companies. We have created RMP and General Duty Clause audit protocol and conducted audits and investigation/improvement programs following significant release events. We also routinely work with Local Emergency Planning Commissions (LEPCs) to coordinate emergency response efforts and exercises.

Our understanding of the regulations and industry needs spans years of experience and commitment to helping industry comply with regulations and operate more efficiently. For example, KTL developed and implemented the Guidance Manual and Training Modules for the Responsible Care Management System (RCMS) and RC14001, ACC’s management system integrating environmental, safety/process safety and security. KTL is also a Preferred Provider of compliance services for NACD member companies and a recognized NACD Responsible Distribution Adviser, providing in-depth support for members and affiliates during Responsible Distribution implementation and integration with other management systems and EHS compliance initiatives.

Regulatory enforcement-driven projects such as those related to RMP require skills in regulatory strategy, negotiations, expert analysis, presentations and testimony—and, equally important—trust and relationship building. KTL can work with companies to:

• Identify/understand/prioritize compliance risks
• Outline steps to improve performance
• Define organizational roles and responsibilities
• Streamline compliance methods
• Plan and conduct required tabletop exercises and coordinate with local emergency response
• Implement, monitor, and continually improve

The audit report communicates the information, findings and opinions derived from the audit.  The report communicates either acceptability of the current status of the management system or reports non-conformances that need corrective action. The following outlines the suggested steps for reporting audit results.

Step 1. Assess the Status of Current Internal Controls

One of the auditor’s main responsibilities is to evaluate whether the current internal controls that govern the management system are adequate. Do the audits:

• Highlight areas of concern or hazards that may be a failure waiting to happen?
• Focus attention of the 20% of the factors that cause 80% of the problems?
• Help to eliminate ineffective controls or make existing controls better?
• Aid in the detection and prevention of deficiencies or non-conformances?
• Look through and investigate possible “homeblindness”?
• Verify the management system links are supportive and feed each other information to assure continual improvement?

The auditors must constantly challenge the status quo and push the management system forward beyond its comfort level.

Step 2. Prepare Audit Report

Most facilities use a formal audit report system. The audit report format is prescribed and followed by the auditor. The auditor typically states:

• Date and time of audit
• Department audited
• Management system clauses audited to
• Personnel interviewed
• Documents reviewed
• Summary of findings
• Conformance or non-conformance determination

Step 3. Discuss Audit Findings

The lead auditor will then take the completed audit report and review the contents with the affected department head. Upon acceptance by the department head, the final audit report should then be signed by the department head verifying acceptance and responsibility for any change(s) required.

Step 4. Determine Plan of Action

The entire reason for conducting internal management system audits is to verify conformance and continually improve on the management system. Therefore, it is extremely important that all identified non-conformances are corrected in a timely manner.

Some companies place all audited non-conformances into their corrective/preventive action process for tracking purposes. Others place only critical non-conformances into the corrective/preventive action process. Regardless of the mechanics of tracking the identified audited non-conformances, it is imperative that corrective action is taken.

Once the corrective action is in place, the auditors should review the actions taken and verify the root cause was identified properly and resolved. An accept or reject decision can then be rendered for the change action.

If acceptable, no further action is required, and the issue is considered resolved. If unacceptable, the department head must complete a new root cause analysis, develop a new action plan, and put the new action plan into place. The auditors will now review the new action plan and make a determination of acceptance or rejection.

Audit Team Members

It is advisable to rotate your internal management system audit team members. This will allow for fresh perspective and a new set of eyes to look at the management system. This serves many purposes:

• Gives a specific timeframe of responsibly for those thinking of enlisting as an auditor
• Allows for gradual increase of responsibility over time; new auditors learn and perform audits, older auditors become mentors for the new auditors, graduates leave program and are viewed by company personnel as “knowledge experts” on the management system
• Allows for fresh perspective on auditing
• Trains numerous employees on the management system
• Reinforces the concept of continuous improvement

Are You Prepared?

Use your answers to the questions below to evaluate your preparation for reporting audit results.

• Has the auditor evaluated the current internal controls for suitability, adequacy, and effectiveness?
• Does the auditor have hard copy evidence of conformance and/or non-conformance?
• Have all questions prepared prior to the audit been satisfactorily answered and explained?
• Is the audit report clear, concise, and informative?
• Does the department head agree or disagree with the findings?
• Are all identified non-conformances tracked and resolved in a timely manner?
• Based on audit non-conformances, are procedures and work instructions being changed and improved?
• Do employees understand the management system is being audited, not the employee?
• Is change readily accepted by company personnel?

BIOTECHNOLOGY FOCUS

Identifying and managing your wastes is not a task to be taken lightly. If waste is incorrectly managed, there are regulatory compliance risks, exposure risks, and potential financial penalties that can impact your business. Given these risks, effective waste management requires investments of time, money, and resources. However, if you are proactive in your efforts to inventory your wastes, understand your requirements, and develop a plan to manage your inputs and outputs, it is possible to turn those investments into value for your organization.

The following six best practices can help ensure you are you managing your waste correctly, efficiently, and cost-effectively—and that you can sustain those efforts for the long term:

1.  Inventory your wastes – Biotech labs and industrial processes traditionally produce many different types of waste that can present significant waste management challenges. A methodical, analytical approach to characterizing and evaluating waste can substantially improve efficiencies when it comes to handling waste and minimize the risks of improper waste management. This is done through an EPA-required waste determination. In addition to reviewing chemicals that are used in processes and the different types of risk they present, a waste determination should evaluate allwaste being generated by processes throughout the facility.

2.  Understand your compliance requirements – The Environmental Protection Agency (EPA) regulates much of the waste generated by industry. Over the past ten years, the Agency has demonstrated an even stronger focus on labs. Additional regulatory agencies that oversee lab and industry operations include the Occupational Safety & Health Administration (OSHA), Department of Transportation (DOT), Department of Homeland Security (DHS), fire department, and others depending upon the type of work being done, chemicals being used, and resulting end products. The waste scenarios seen in labs and industry are countless, and each may hold associated regulatory compliance requirements. While this clearly presents business risks, it also provides a unique opportunity to create strategies to manage wastes more effectively and efficiently, improve safety, and reduce the potential costs of regulatory compliance.

3.  Understand your business processes – Companies who want to proactively manage their waste need to go through the process of understanding where your waste fits into your business processes—and what you need to do with not only your waste, but also your operations, to minimize risk, reduce costs, and ensure compliance. Having business and production processes mapped out helps companies improve the interconnected set of processes, sub-processes, activities, and tasks that allow the business to manage waste most effectively. A thorough review of business and operational processes and the waste being generated further creates the opportunity for a “bottom-to-top” evaluation of all regulatory compliance. It is a process of understanding what you have, where it fits, and what you need to do with it to minimize risk, reduce costs, and ensure compliance.

4.  Get the right parties trained – One of the most common violations identified by both DOT and EPA is failure of personnel signing hazardous waste manifests to have appropriate DOT hazardous waste training. Failure to meet this training requirement can result in substantial financial penalty. Perhaps even more important, lack of training may also impact the understanding of employees in how to correctly—and safely—perform their duties. There are many people who touch waste at various points in the process and they all need to be trained on how to work with it in a manner that is safe and compliant with regulatory requirements.

5.  Develop waste management strategies – Are there waste streams that you are paying too much to manage? Are there alternatives to the reagents or kits you are using that may minimize your risk and improve safety in your lab? Are there strategies that can make waste management simpler, more cost-effective, and more compliant that you could implement in your lab? As key indicators of waste quantities are identified, strategies for internal process changes that can minimize waste generation can be implemented.

When developing your strategies, focus on managing waste as close to the source(s) as possible. There are frequently alternatives to hazardous, universal, biohazardous, and special waste management that will minimize risk and improve financials. These waste minimization strategies need to be identified and evaluated to determine their applicability and potential impacts. Options that Kestrel has investigated and assisted with implementing include:

• Treating hazardous waste to minimize quantities for disposal
• Recycling used solvents through evaporation and reclamation strategies
• Solidifying nonhazardous waste waters with associated subtitle D landfilling

6.  Establish a system to sustain ongoing compliance – Documenting waste management procedures and processes, along with management oversight and continual review and improvement, is key to ensuring ongoing compliance. Technology (i.e., a compliance information management system (IMS), apps, tools) can help create process standardization, operational efficiencies, and, subsequently, consistent and reliable compliance/waste management performance. Do you have permitting requirements? Does your staff need training? How do you maintain your records? Are there regular (e.g., annual, semi-annual) plans and/or reports you need to submit? Do you have routine inspections and monitoring? All these things can and should be built into a compliance IMS so they can be managed more efficiently.

Through an evaluation of chemicals onsite, development of an inventory of both chemicals used and waste generated, and identification of processes to efficiently and effectively manage waste, businesses/labs can ensure they understand and meet their EHS regulatory obligations in the most efficient ways possible.

Understanding your waste requirements and then getting your facility in compliance with those requirements are important steps in your waste management efforts. However, effective waste management is not a one-time effort. It takes ongoing resources and tools to sustain ongoing compliance. Consider the following:

• How do you track your waste inventory?
• Do you have ongoing permitting requirements to manage?
• Does your staff need periodic training?
• Are there regular (e.g., annual, semi-annual) plans and/or reports you need to submit?
• Do you have routine inspections and monitoring?
• How do you maintain your records? Where do you house your documentation?

Managing all these things and effectively resourcing ongoing regulatory compliance needs can quickly become overwhelming—especially for those companies without a dedicated team of full-time environmental, health and safety (EHS) staff.

Technology Tools

Documenting waste management procedures and processes, along with management oversight and continual review and improvement, is key to ensuring ongoing compliance. Technology (i.e., a compliance information management system (IMS), apps, tools) can help create process standardization, operational efficiencies, and, subsequently, consistent and reliable compliance/waste management performance.

However, it must be noted that applying technology to operations isn’t about just finding and buying a software tool. It is about:

• Understanding the business need;
• Customizing and integrating the appropriate tool into existing operations; and
• Deploying it so it is effectively applied.

Scalable Solutions

Virtually every regulatory program, including those related to waste management, has compliance requirements that call for companies to fulfill a number of common compliance activities. While they do not necessarily need to be addressed all at once or from the start, considering the eight functions of compliance when designing compliance efficiency tools helps define the starting point and build a vision for the end result.

Compliance efficiency tools built on an Office 365 platform offer an adaptable/scalable solution that can allow you to more efficiently manage compliance tasks, corrective and preventive actions (CAPAs), and other project activities to ensure you are meeting your compliance requirements. Translating these common compliance functions into modules that can be instrumental in establishing or improving a company’s capability to comply, including:

• Facility profiles
• Waste inventories
• Compliance calendars
• Assessments & inspections
• Mobile forms & checklists
• Audit tracking
• Permit management/tracking
• Document and records management

Adding Business Value

In the end, implementing compliance efficiency tools such as this can provide the resources needed to effectively manage your waste management program—plus a number of other lasting benefits to the overall business:

• Helps improve the company’s capability to comply on an ongoing basis
• Establishes compliance practices
• Creates a strong foundation for internal and 3rd-party compliance audits and for answering outside auditors’ questions (agencies, customers, certifying bodies)
• Helps companies know where to look for continuous improvement
• Reduces surprises and unnecessary spending on reactive compliance-related activities
• Informs management’s need to know
• Enhances confidence of others (e.g. regulators, shareholders/investors, insurers, customers), providing evidence of commitment, capability, reliability and consistency in the company’s waste management program

We are excited to announce that Kestrel Management LLC (Kestrel) and Tellevate LLC (Tellevate) have merged to provide enhanced compliance and management consulting services to industry and government agencies. The newly merged entity will be conducting business as Kestrel Tellevate LLC (KTL) as of November 1, 2019.

Partnership History

Kestrel and Tellevate have a long-standing relationship dating back to 2011. “Our companies’ proactive partnership strategy has allowed us to quickly assemble the right resources to respond efficiently to changing cilent needs and ensure successful projects,” explains Joseph Tell, KTL Principal. “Formalizing this partnership through a merger will allow us to create more efficiencies in our business to bring more value to our clients and elevate their operations and business processes.”

Each entity brings resources and expertise to KTL to enhance the newly formed company’s ability to provide more comprehensive services to both industry and government. “Kestrel has a 20+-year history providing environmental, health, safety, quality, and food safety consulting services to a diverse group of industrial clients,” says KTL Principal Evan Fitzgerald. “Tellevate brings an extensive background in providing EHS management solutions to both industry and government contracts. This is a merger that will allow KTL to grow in both markets and to better serve our clients.”

What This Means for You

Your daily interactions and existing contracts with Kestrel Management LLC or Tellevate LLC will remain largely unchanged. Going forward, there may be some new faces (and expertise) to join your project team. Any future changes to our existing systems/process will be communicated to you, as needed.

Together, KTL will continue to help our clients reduce operational risks, assure regulatory compliance, and implement reliable management systems for continual improvement in the areas of environment, health & safety, food safety, and quality. We provide comprehensive services to both industrial clients and government agencies in the following areas:

• EHS Compliance Assurance
• Process, Program & Project Improvement
• Management Systems
• Food Safety Certification & Compliance
• Information Management Solutions

Logistics

The new entity’s primary branches are located in Decatur, Georgia; and Madison, Wisconsin; with satellite offices in Chicago, Illinois; Des Moines, Iowa; Ann Arbor, Michigan; St. Louis, Missouri; Milwaukee, Wisconsin; and Washington, D.C. Additional information can be found at https://kestreltellevate.com.

All materials that are part of the food supply chain, including food packaging and contact materials, can significantly influence food safety. Inadequate packaging can fail to protect food properly or allow for contamination or adulteration. Producing safe food demands food safety management and compliance from all who contribute to the final food packaging and contact materials—those supplying materials, making the packaging, manufacturing food contact materials, and distributing the final packaged products.

Setting the Standard

Under the Global Food Safety Initiative (GFSI) standards, major schemes (e.g., IFS PACsecure, the BRC Global Standard for Packaging, SQF Packaging, and FSSC 22000) provide guidance for the producers of packaging materials to ensure the safety and quality of food and non-food products.

The GFSI standards are described as different but equal. It is important that companies determine the best fit of the GFSI options for their own company requirements. All of the standards help manufacturers, packers/fillers, and retailers demonstrate that every reasonable measure has been taken to avoid a food safety incident. Qualified legal reviews have shown that these GFSI benchmarked standards also meet nearly all of the food safety requirements of FDA/FSMA.

The GFSI standards address the requirements to assure food safety by applying the Hazard Analysis and Critical Control Points (HACCP) and Good Manufacturing Practice (GMP) principles specific to food packaging risk and this sector of the food industry. The standards help manufacturers take responsibility by establishing a recognized Food Safety Management System (FSMS).

Each food packaging standard follows a defined documentation program for GFSI certification, and may fit specific packaging applications and food risk differently. As a general example, the FSSC 22000 certification scheme uses ISO 22000 and PAS 223 to identify the requirements for certification and to define a set of food safety requirements, as listed in sections 4-8 of the standard (see table below).

Preparing for Certification

Taking measures upfront to adhere to food safety standards helps assure that food packaging will meet in-use demands and regulatory requirements so that the food contents can be enjoyed safely. To prepare for certification, companies should:

• Identify regulatory requirements, which may include commissioning of plant and equipment to confirm compliance with food safety requirements
• Set clear target dates for assessment and implementation
• Establish an informed and thorough materials evaluation process
• Identify and document food safety hazards and relevant control measures (HACCP/GMP)
• Identify applicable GMPs (e.g., pest control, equipment & building maintenance, housekeeping & cleaning)
• Establish a robust FSMS that aligns with existing management systems (i.e., quality, environmental, health & safety)
• Implement any needed structural improvements
• Institute ongoing material and packaging testing protocols, as well as strict handling and use requirements

Case Study: Food-Grade Paper Mill

Kestrel has been involved with a number of paper and packaging facilities considering expanding production operations to manufacture food-grade product that meets GFSI, FSSC 2200, GMP, HACCP, and customer requirements. The following provides an example of how a Kentucky-based paper mill commissioned its site to manufacture paper products to meet the needs of food customers nationwide.

Phase 1: HACCP/GMP Compliance Analysis

Due to the recent changes in regulatory and certification requirements, this paper mill needed to be confirmed or commissioned as food-material compliant to continue its food-grade materials manufacturing. Building on its existing management system documentation, originally designed and certified to ISO 9001, the mill determined that it would comply with FDA food contact paper requirements and sought alignment with the GFSI FSSC 22000 standard.

Kestrel conducted a preliminary GMP/HACCP certification analysis to provide a third-party audit report on the mill’s compliance to regulatory and industry standards. The desktop, physical site, and process reviews included analysis of the following:

• Site HACCP program
• Risk analysis assessment
• GMP requirements under FDA
• Supplier program and receipt of goods
• Customer requirements and release of goods
• CAPA management
• Food safety objectives/policy

Based on this assessment, Kestrel established a project workplan and estimated timeline to develop and implement a food safety management program for both FDA and GFSI FSSC 22000 certification requirements.

Phase 2: GMP/HACCP FSMS

The mill proceeded with establishing the required programs for compliance to regulatory and industry standards for the manufacture of food-grade product meeting the processing requirements under GMP and HACCP. Specific project goals for this phase included:

• Designing and implementing a sustainable and compliant FSMS
• Developing a system that fully complies with all the FDA and industry (GFSI/HACCP) programs, procedures, and metrics
• Using a design and implementation process that draws from existing business/management systems and documentation
• Using a process that actively engages the workforce in the design/development, implementation, and ongoing improvement activities of the FSMS to create a participative food-safe packaging culture
• Using a scalable design and implementation process that is responsive to the company’s resources

Kestrel began this phase of the project by focusing on foundational management system elements and working stepwise through the GMP and HACCP programs. Project tasks included:

• Completing food safe packaging compliance register
• Conducting physical review
• Developing HACCP/preventive controls plan
• Creating GMP requirements list
• Developing food safety plan policies/procedures
• Determining second level procedures and work instructions
• Developing/providing training modules
• Conducting internal audits
• Starting management reviews
• Commencing program integrity audits and status updates
• Integrating with current corrective actions and management processes
• Starting FSSC certification process (staged)

Kestrel’s most recent review and assessment of the mill’s management systems and approaches to food safety standards indicate that the overall business integrity and compliance is at the highest level in respect to food safety packaging standards. A legal review has confirmed that the process and developed programs also meet food safety legal requirements.

Benefits

The flexible packaging industry has experienced rapid growth. Ongoing innovation has led to more new materials being used, growth in packaging formats, extreme in-use conditions, and increasingly more stringent FDA regulations and food safety standards. Commissioning plants for food safety is vital to operating within the food industry.

A company’s achievement as a reliable supplier is linked to its capability to provide safe products. In addition, adhering to food safety standards:

• Allows manufacturers to report on their status to key stakeholders (e.g., food retailers, customers)
• Covers areas of hygiene and product safety throughout the packaging industry
• Helps ensure that suppliers are also following good hygiene practices to complete the due diligence chain
• Ensures that a sustainable quality and product safety system is established and continually improved