FDA Food Safety Modernization Act (FSMA) Compliance Support (Consultant)

Short Term Technical Assistance

FDA Food Safety Modernization Act (FSMA) Compliance Support (Consultant)

USAID Trade Reform and Development in Egypt (TRADE) Activity

Cairo, Egypt

Background: 

Land O’Lakes Venture37 is a 501(c)(3) nonprofit committed to helping communities around the world build economies by strengthening local agriculture, helping agribusinesses create jobs and linking farmers to markets. Since 1981, it has implemented over 315 integrated dairy, livestock, and crops development programs in nearly 80 countries — creating lasting impact by linking farmers, businesses, and the public and private sector in local and global contexts. Land O’Lakes Venture37’s long-standing affiliation with Land O’Lakes, Inc. sets it apart. Land O’Lakes, Inc. is one of America’s largest farmer-owned cooperatives. It supports Land O’Lakes Venture37 project implementation with nearly 100 years of expertise in dairy, animal nutrition, crop inputs and agricultural insights and technologies. This gives Land O’Lakes Venture37 development projects a unique global view of agriculture, food, and the power of well-functioning market systems. Land O’Lakes, Inc. supports these efforts as part of its enterprise purpose of Feeding Human Progress at home and around the world.

Project Summary: 

The USAID Trade Reform and Development in Egypt (TRADE) Activity is a five-year, $36.3 million contract implemented by Palladium with technical support from Land O’Lakes Venture37 and a consortium of other international and local subcontractors. 

The TRADE Activity will increase Egypt’s international trade by increasing exports from SMEs, and in particular New and Expanding Export-Ready Enterprises (NEEREs). This will be achieved by addressing the constraints that impede the competitiveness of Small and Medium-sized Enterprises (SMEs). Over the life of the contract, the TRADE Activity will attain the following three results:

1) Enhanced Export Capacity of SMEs, in particular NEEREs;

2) Strengthened Public and Private Trade-Support Institutions; and,

3) Improved Trade and Investment Policy, Regulatory and Institutional Environment.

Purpose and Objective of the Consultancy:

The US market stands as a prominent destination for Egyptian food exports, constituting 4.3% of the total food export share. In 2023 certain sectors witnessed growth in export revenues, indicating the potential to continue increasing overall export earnings.

In partnership with the Food Export Council (FEC), USAID and TRADE are actively engaged in facilitating collaborative efforts aimed at orienting FEC members and ensuring their compliance with Food and Drug Administration (FDA) and Food Safety Modernization Act (FSMA) regulations.

Building upon the initiatives undertaken in previous years, efforts are underway to support the qualification of local lead instructors within FEC for Preventive Controls Qualified Individuals (PCQI) for Human Food (HF), in collaboration with the International Food Protection Training Institute (IFPTI). To further this objective, the project seeks to engage a consultant to provide coaching services to the newly approved cadre during training sessions. The consultant will ensure that instructors’ performance aligns with the standards set by IFPTI/ (Food Safety Preventative Controls Alliance (FSPCA) and facilitates the attainment of a higher level of competency among participants.

Furthermore, the consultant will assist FEC members in gaining a deeper understanding of the FDA registration process and guide them in completing their registrations. Leveraging their expertise in FDA compliance, the consultant will also provide technical support to FEC members regarding FDA Detention Without Physical Inspection (DWPE) and offer strategies to address potential violations.

Consultant Tasks:

Under this scope of work, the Consultant is expected to complete the following tasks:

• Provide technical coaching sessions for newly approved PCQI HF local lead instructors both prior to and during their training sessions, as well as ongoing support after the sessions.
• Develop a comprehensive and accessible guide outlining the FDA registration process. Conduct a webinar or training session for FEC members to ensure they are well-informed and equipped with the necessary technical support for any inquiries or clarifications they may require.
• Create a detailed guidance document regarding FDA Detention Without Physical Inspection (DWPE) procedures, including steps for removing a product or firm from DWPE status (import alert list). Consider conducting a webinar to educate Egyptian food exporters about these procedures and keep them updated.
• Develop a clear guidance document outlining FDA requirements for applying for food contact substances approval and provide guidance on achieving compliance for Egyptian exporters. Consider hosting a webinar to inform Egyptian food exporters about these requirements and ensure they understand how to comply.
• Draft a comprehensive post-consultancy report in English, detailing the purpose of the consultancy, progress achieved, observations made, any issues or challenges encountered, and outline expected follow-up activities by USAID TRADE or its partners.

Consultant Deliverables:

Under this scope of work, the Consultant is expected to complete the following deliverables:

• Technical coaching sessions for newly approved local lead instructors in Preventive Control in Human Food (PCHF)/PCQI, including course registration and ongoing support during training sessions from March to September 2024.
• Comprehensive guidance document on the FDA registration process to FEC members, as well as a webinar to ensure their familiarity and proficiency in navigating the registration procedure.
• Comprehensive guidance documents on FDA Detention Without Physical Examination (DWPE), including procedures for companies to request removal from the DWPE list and submission of evidence.
• Comprehensive guidance document outlining FDA requirements for food contact substances and assistance to Egyptian exporters in achieving compliance, as well as a webinar to enhance exporters’ capacities in meeting these requirements.
• A concise post-consultancy report in English outlining the purpose of the consultancy, detailing progress made, observations, and any encountered issues or challenges. Additionally, provide information on expected follow-up activities by USAID and/or TRADE or its counterparts.

Required Qualifications:

• Must be a certified FSPCA Trainer of Trainers for the PCQI HF curriculum and be well-versed in V2.
• Experienced in FDA-FSMA and compliance requirements.
• Proven experience in food industries compliance to global markets requirements in particular US markets and FSMA requirements.
• Experience in developing guidance for the industry to ensure compliance with requirements.

Reporting: The Consultant will report to TRADE’s Senior Food Safety Advisor.

Contracting: The selected individual will be awarded fixed price consultancy agreement per the deliverables through on or about December 31, 2024 .

Payment will be made for all the deliverables once completed and approved.

Application Instructions: Interested applicants should submit their CV and proposed fee for completing the scope of work to Piper Marsh at pmarsh@landolakes.com. If more than one individual is proposed as part of a team or Consultation firm, all experts’ CVs should be included in the submission. The consultant or firms should submit their profiles, technical and financial proposals.

Land O’Lakes Venture37 will never ask you for personally identifiable information, and we will never request money or payment during the recruitment or employment process.

Land O’Lakes Venture37 is an equal-opportunity employer and an organization striving to help global communities thrive through agriculture. We consider all qualified applicants without regard to race, religion, national origin, age, sexual orientation, gender identity, disability, or veteran status, among other factors. Our culture values a diversity of voices. So bring us your unique experiences, your workstyle, and your dreams — they’ll only make us stronger.

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