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Beltway Beat

The Effectiveness of U.S. Food Laws Over Private Standards

By Sayed M Naim Khalid
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Introduction

The safety of our food supply is critical to public health, economic stability, and consumer confidence. The United States has developed a comprehensive regulatory framework for food safety that relies heavily on federal laws and oversight. This system involves multiple federal agencies, state and local governments, and numerous statutes designed to ensure food safety from farm to table. Private standards, such as those established by the Global Food Safety Initiative (GFSI), also play a role, but they are not a substitute for the regulatory power and public accountability inherent in U.S. food laws. This artilce argues that U.S. food laws are more effective than private standards and that businesses can achieve sufficient food safety by adhering to these laws without incurring additional costs associated with private standard implementation.

The Current U.S. Food Safety System

The U.S. food safety system is multifaceted, involving producers, processors, shippers, retailers, and consumers. The government, particularly through agencies like the FDA, USDA, EPA, and CDC, plays a critical role in establishing and enforcing food safety standards. These agencies work under numerous statutes and interagency agreements to ensure the safety of the food supply. The system, while complex and somewhat fragmented, is backed by legal enforcement, scientific research, and public accountability.

The Effectiveness of U.S. Food Safety Laws

The U.S. food safety regulatory system is extensive and multifaceted, involving numerous agencies with specialized roles. The Food and Drug Administration (FDA), the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the National Marine Fisheries Service (NMFS) of the Department of Commerce all play crucial roles in ensuring food safety. These agencies operate under a framework of more than 35 statutes overseen by 28 Congressional committees, reflecting the complexity and thoroughness of the system.

The FDA, for instance, regulates domestic and imported foods, except for meat and poultry products, ensuring they are safe, sanitary, and properly labeled. The agency has regulatory authority over more than $1 trillion in products sold annually—about 25 cents of every dollar spent by consumers, including surveillance, risk assessment, research, inspection, and education. Similarly, the FSIS is responsible for ensuring the safety of meat and poultry products, employing roughly 7,400 inspectors to oversee 6,200 slaughtering and processing plants through continuous and daily inspections.

The statutory mandates for these agencies are comprehensive. For example, the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) enforces tolerances for pesticide residues, approves food additives, and ensures that food processing plants adhere to safety standards. The FSIS, by law, must conduct carcass-by-carcass inspection during slaughter, ensuring that meat and poultry products are safe for consumption. USDA) announced in 2021 that government will invest more than US$4 billion to improve the food system.

Government Enforcement and Public Accountability

U.S. food laws are enforced by federal agencies with the authority to conduct inspections, enforce regulations, and impose penalties for non-compliance. This legal backing ensures a high level of adherence to food safety standards. For example, the FDA and USDA conduct regular inspections and surveillance to ensure compliance with food safety laws. This system of oversight provides a level of public accountability that is essential for maintaining consumer trust and preventing foodborne illnesses.

Scientific Basis and Comprehensive Coverage

U.S. food laws are grounded in scientific research and are regularly updated to reflect the latest food safety information. These laws cover a wide range of food products and hazards, including microbiological contaminants, pesticides, and additives. This comprehensive approach ensures that all potential risks are addressed, providing a higher level of protection for consumers.

Economic and Consumer Protection

Effective food safety regulations prevent large-scale foodborne illness outbreaks, reducing healthcare costs and economic losses. By ensuring that food products meet safety standards, the government protects consumers from the dangers of contaminated or unsafe food. This protection is crucial for maintaining public health and economic stability.

Limitations of Private Standards

While private standards like those established by GFSI can complement public regulations, they are not a substitute for the robust framework provided by U.S. food laws. Private standards are voluntary and lack the enforcement power of government regulations. They often require third-party audits, which can be costly and lead to inconsistent implementation due to variability in auditor competency and interpretation of standards.

Cost and Market Pressure

Certification and compliance with private standards can be expensive, particularly for small and medium-sized enterprises. These costs can create barriers to market entry and place unnecessary financial burdens on businesses. Moreover, companies may feel pressured to adopt private standards to remain competitive, regardless of whether these standards offer additional safety benefits over existing regulations.

Transparency and Accountability

Private standards are enforced through independent third-party audits, which may lack the transparency and public accountability of government inspections. The results of these audits are not always made public, and there is less oversight to ensure that auditors maintain high standards of integrity and competence.

Limited Scope and Inequality

Private standards may not cover all aspects of food safety, especially those specific to local contexts or emerging threats. Additionally, smaller companies and producers in developing countries may face significant barriers to accessing certification due to costs and resource constraints, leading to inequality in market access and potentially restricting trade opportunities.

The Case for Relying on U.S. Food Laws

Given the comprehensive and enforceable nature of U.S. food laws, businesses can achieve sufficient food safety by adhering to these regulations without incurring additional costs associated with private standards. The legal framework provided by U.S. food laws is designed to protect consumers and ensure food safety across the entire supply chain. By focusing on compliance with these laws, businesses can avoid the complexities and expenses of private certification while still maintaining high standards of food safety.

HACCP Systems and FSMA

The implementation of Hazard Analysis Critical Control Point (HACCP) systems and the Food Safety Modernization Act (FSMA) has strengthened the U.S. food safety framework. HACCP systems focus on preventing hazards at critical points in the production process, while FSMA emphasizes proactive measures to prevent food safety issues. These regulatory approaches are widely recognized as effective means of ensuring food safety and can be more cost-effective than adhering to multiple private standards.

Comparison with Private Standards

Private food safety schemes, like those endorsed by GFSI, offer standardized protocols for food safety management across global supply chains. These schemes are often seen as more stringent and market-driven, providing a competitive edge and reassurance to consumers and business partners. However, these private standards come at a cost. Businesses must pay for certification, ongoing compliance audits, and the implementation of specific protocols that may overlap with existing regulatory requirements.

Comparison of U.S. Food Laws vs. GFSI Standards

Pros and Cons of GFSI Standards

GFSI Standards

Pros

Cons
  1. Global Recognition: GFSI standards are recognized worldwide, facilitating international trade and ensuring global food safety.
  2. Flexibility: GFSI standards allow for flexibility and adaptability to new food safety practices and technologies.
  3. Market Competitiveness: Certification to GFSI standards can enhance a company’s reputation and market access.
  4. Private Sector Leadership: GFSI involves private sector stakeholders, fostering innovation and industry-driven solutions.
  5. Standard Harmonization: GFSI standards harmonize various private food safety schemes, reducing duplication and confusion.
  6. Risk-Based Approach: GFSI emphasizes a risk-based approach to food safety, focusing on critical control points and preventive measures.
  7. Continuous Improvement: The GFSI framework encourages continuous improvement and regular updates to standards.
  8. Third-Party Audits: Independent third-party audits provide an objective assessment of a company’s food safety practices.
  9. Training and Resources: GFSI offers extensive training and resources to help companies comply with standards.
  10. Consumer Confidence: Certification to GFSI standards can enhance consumer confidence in the safety and quality of food products.

 
  1. Cost: Certification and ongoing compliance with GFSI standards can be expensive, especially for small and medium-sized enterprises.
  2. Voluntary Nature: As a voluntary scheme, GFSI lacks the legal enforcement power of government regulations.
  3. Inconsistent Implementation: Variability in auditor competency and interpretation of standards can lead to inconsistent implementation.
  4. Complexity: The process of achieving and maintaining GFSI certification can be complex and resource-intensive.
  5. Overlap with Regulations: GFSI standards can overlap with existing government regulations, creating redundancy.
  6. Market Pressure: Companies may feel pressured to adopt GFSI standards to remain competitive, regardless of their actual necessity.
  7. Audit Fatigue: Frequent audits and certifications can lead to audit fatigue and a focus on passing audits rather than genuine food safety improvements.
  8. Limited Scope: GFSI standards may not cover all aspects of food safety, particularly those specific to local contexts or emerging threats.
  9. Transparency Issues: Private certification bodies may not be as transparent as government agencies in disclosing audit results and non-compliance.
  10. Access Inequality: Smaller companies, particularly in developing countries, may face barriers to accessing GFSI certification due to costs and resource constraints.

 

Pros and Cons of U.S. Food law

U.S. Food Laws

Pros

Cons
1.     Government Enforcement: U.S. food laws are enforced by federal agencies like the FDA and USDA, providing a robust and legally backed framework for food safety.

2.     Comprehensive Coverage: These laws cover a wide range of food products and hazards, including pesticides, additives, and microbiological contaminants.

3.     Public Accountability: Government agencies are accountable to the public, with transparent operations and public reporting of food safety issues.

4.     Standardization: U.S. food laws provide standardized regulations across the country, ensuring uniform food safety practices.

5.     Scientific Basis: The laws are based on scientific research and updated with the latest food safety information.

6.     Interagency Coordination: Multiple agencies collaborate, providing a multi-faceted approach to food safety.

7.     Consumer Protection: The primary goal is to protect consumers from foodborne illnesses and unsafe food products.

8.     Economic Impact: Government-regulated food safety can prevent large-scale foodborne illness outbreaks, reducing healthcare costs and economic losses.

9.     Legally Binding: Compliance is mandatory, with legal consequences for non-compliance, ensuring high levels of adherence.

10.   Educational Resources: Government agencies provide extensive educational resources and support to food businesses to help them comply with regulations.
  1. Bureaucracy: The complexity and fragmentation of the regulatory system can lead to inefficiencies and slow responses to emerging food safety issues.
  2. Resource Limitations: Federal and state agencies often face budget and staffing constraints, impacting their ability to perform inspections and enforce regulations.
  3. Inconsistencies: Variation in enforcement and standards across different states and localities can create inconsistencies in food safety practices.
  4. Regulatory Overlap: Overlapping jurisdictions between agencies can cause confusion and redundancy in regulatory efforts.
  5. Slow Adaptation: Government regulations can be slow to adapt to new food safety technologies and practices.
  6. Burden on Small Businesses: Compliance with complex regulations can be burdensome for small food businesses with limited resources.
  7. Limited Global Reach: U.S. laws apply primarily to domestic producers, potentially creating gaps in food safety for imported products.
  8. Focus on Compliance: The emphasis on regulatory compliance may sometimes overshadow the focus on innovative food safety improvements.
  9. Inspection Gaps: Resource limitations can lead to infrequent inspections, reducing the effectiveness of enforcement.
  10. Perceived Rigidity: Some stakeholders view government regulations as rigid and inflexible, stifling industry innovation.

 

Conclusion

While both U.S. food laws and GFSI standards have their strengths and weaknesses, their effectiveness depends on the specific context and needs of the food industry stakeholders. U.S. food laws provide a legally enforceable and standardized framework, ensuring a high level of consumer protection and public accountability. On the other hand, GFSI standards offer flexibility, global recognition, and industry-driven innovation, though they come with significant costs and may lack the enforcement power of government regulations.

The U.S. food safety system, despite its complexity and fragmentation, provides a robust and effective framework for ensuring the safety of the food supply. Federal regulations enforced by agencies like the FDA and USDA offer comprehensive coverage, scientific grounding, and legal enforcement, which are critical for protecting public health and consumer confidence. While private standards can play a supportive role, they cannot match the effectiveness and public accountability of government regulations. By adhering to U.S. food laws, businesses can achieve high standards of food safety without incurring the additional costs and complexities associated with private certification.

For optimal food safety, a balanced approach that leverages the strengths of both systems may be the most effective solution. This hybrid strategy would combine the stringent, enforceable standards of U.S. food laws with the flexibility and global perspective of private standards like GFSI, ensuring comprehensive protection for consumers while promoting innovation and international trade.

Further reading:

  1. (2023, July 13). FSMA Final Rule on Accredited Third-Party Certification. Retrieved July 18, 2024, from US Food and Drug Administration: https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-accredited-third-party-certification
  2. Foulis, D. (2024, Feb 14). Four benefits of gaining GFSI certification. Retrieved July 18, 2024, from Ideagen: https://www.ideagen.com/thought-leadership/blog/four-benefits-gfsi-certification
  3. (2011, March). Enhancing Food Safety Through Third Party Certifications. Retrieved July 18, 2024, from Mygfsi.com: https://mygfsi.com/wp-content/uploads/2019/09/Third-Party-Certification-GFSI-White-Paper.pdf
  4. Kaylegian, K. (2021, April 13). The Food Safety Modernization Act (FSMA). Retrieved July 18, 2024, from PennState Extension: https://extension.psu.edu/the-food-safety-modernization-act-fsma
  5. Loucks, S. (2024, May 31). Why Should My Business Become GFSI Certified? Retrieved July 18, 2024, from FoodReady: https://foodready.ai/blog/why-should-my-business-become-gfsi-certified/
  6. Scott, J. (2023, Nov 8). FDA FSMA: Providing value beyond compliance. Retrieved July 18, 2024, from IBM: https://www.ibm.com/blog/fda-fsma-providing-value-beyond-compliance/
  7. Ng S, Shao S, Ling N. Food safety risk-assessment systems utilized by China, Australia/New Zealand, Canada, and the United States. J Food Sci. 2022 Nov;87(11):4780-4795. doi: 10.1111/1750-3841.16334. Epub 2022 Oct 26. PMID: 36285586; PMCID: PMC9828015.
  8. Halabi, Sam. 2016. The Battle between Public and Private Food Safety Standards. Yale Journal of Regulations. https://www.yalejreg.com/nc/the-battle-between-public-and-private-food-safety-standards/ (access on 6/29/2024)
  9. Soon JM, Baines RN. Public and Private Food Safety Standards: Facilitating or Frustrating Fresh Produce Growers? Laws. 2013; 2(1):1-19. https://doi.org/10.3390/laws2010001
  10. National Research Council (US) Committee on the Review of Food and Drug Administration’s Role in Ensuring Safe Food; Wallace RB, Oria M, editors. Enhancing Food Safety: The Role of the Food and Drug Administration. Washington (DC): National Academies Press (US); 2010. 2, The Food Safety System: Context and Current Status. Available from: https://www.ncbi.nlm.nih.gov/books/NBK220410/
  11. Institute of Medicine (US) and National Research Council (US) Committee to Ensure Safe Food from Production to Consumption. Ensuring Safe Food: From Production to Consumption. Washington (DC): National Academies Press (US); 1998. 2, The Current US Food Safety System. Available from: https://www.ncbi.nlm.nih.gov/books/NBK209121/

 

Shawn K. Stevens, Food Industry Counsel
Food Safety Attorney

FDA’s Tactics to Reduce Outbreaks and Recalls

By Shawn K. Stevens
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Shawn K. Stevens, Food Industry Counsel

The advent of PulseNet in the late 1990s enabled more effective identification of outbreaks, even as many of them overlapped. The database brought to light the fact that many of the products sold in commerce nationwide contained ingredients that were at risk of contamination with dangerous pathogens. In many instances, these ingredients were in products from a single lot or batch and then sold by a single supplier to dozens of customers. From there, they were used in hundreds of products that would be distributed into thousands of retail locations.

Attend Food Safety Tech‘s Listeria Detection & Control Workshop | May 31–June 1 in St. Paul, MN | LEARN MOREFDA created the Reportable Food Registry (RFR) as a way to prevent the shipment of contaminated ingredients into the food supply. If received ingredients or products test positive for contaminants, the RFR requires that the company inform FDA. The agency uses the reports to take regulatory action against the original supplier and requires that all ingredients or products from all potentially affected lots be recalled from commerce. Because the RFR allows FDA to immediately begin tracking and containing ingredients testing positive for pathogens, its introduction in 2009 resulted in a significant spike in recalls.

Driven by the recalls triggered by PulseNet and the RFR, a national perception about an extremely unsafe U.S. food supply began to emerge. The public and media demanded that Congress take action, and so FSMA was born. The regulations require all FDA-regulated food companies to develop and implement written preventative control programs designed to control pathogens and other hazards in food. As a result, food companies will face heightened regulatory risk, scrutiny and exposure.

To further decrease the incidence of outbreaks and recalls, FDA is implementing regulatory enforcement initiatives that include sampling food products at retail for the presence of pathogens; conducting microbiological profiling of food processing facilities during routine inspections; and exploring criminal sanctions against companies that have been linked to positive samples in food products or production facilities associated with an outbreak or foodborne illness.

Microbiological Sampling in Retail

FDA is sampling products intended for human consumption as well as those for animal consumption. As testing continues at the retail level, the likelihood of more food products testing positive for the presence of pathogens is much higher. When positive product samples are found, FDA will take immediate action against the company that processed the product and require the company to recall all affected product. The agency will also demand access to the production facility at issue and conduct extensive environmental sampling, including from drains, floors, walls, production equipment, and finished products, in an effort to find the same strain as the sample testing positive at retail.  If product or environmental samples test positive, FDA will perform genetic DNA testing on the isolates and compare the DNA fingerprints against those of the isolates collected from sick case patients in PulseNet over the past 15 years. If a match between the DNA fingerprint and an illness(es) in PulseNet is found, the agency will presume that these illnesses were caused by product originating from that particular facility. FDA will also demand access to all food production and microbiological testing records from previous months, or years, and critique those records.

Microbiological Sampling in Food Production Facilities

In accordance with FSMA, FDA will inspect all food production facilities (drains, floors, walls, food processing equipment, and finished products) that process high-risk ingredients or food products within the next three years (lower risk facilities will be inspected within the next five years). The agency is also performing extensive microbiological profiling of the food processing environment in all production facilities during routine inspections. If a positive sample is found, FDA may require the company to recall the affected product. It is expected that the level of sampling will intensity in the coming months and years as a result of FSMA mandates. And as the extensive microbiological sampling in food production facilities continues, FDA will perform genetic DNA testing on any positive samples collected, once again comparing the DNA fingerprints of samples against those of sick case patients over the last two decades. If a match is found, FDA will take the same course of action as in retail and presume all illnesses were caused by a food product originating from that specific facility. When that occurs, in addition to the potential recalls that may be required, the food companies at issue may become the target of a criminal investigation as well.

My next column will cite recent examples of FDA’s criminal offensive against food companies.