Internship Projects

Principle Investigator: Rebecca Bell /, Christopher Grim

Location: Human Foods Program (HFP), Wiley Building, 5001 Campus Drive, College Park, MD (In-Person)

Objective:

1. Evaluate the die-off rate of Salmonella stored on the dead-end ultrafilter and in backflush solution
2. Evaluate rapid screening methods for the detection of Salmonella in spiked DEUF samples
3. Evaluate a single pre-enrichment/enrichment workflow using the STEC enrichment broth for ease of workflow with regulatory samples
4. Evalute Salmonella culture dynamics and diversity using metagenomics
5. Improve methods for the isolation of the diversity of Salmonella serovars within a single sample

Project Needs and Duration:

• Have a basic understanding of aseptic technique and basic microbiological culture methods such as streaking plates for isolation.
• Preferable to have some basic background knowledge of molecular techniques such as PCR and DNA isolation.
• Preferable to have background knowledge in whole genome sequencing and metagenomic concepts.
• Preferable to have previous lab experience in microbiology, molecular biology or a related field. This could be course work laboratory classes or independent research studies.

The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

This project will optimize the methods used for the collection, detection and isolation of Salmonella using dead-end ultrafiltration (DEUF) from water. This project aims to improve the cultural method by streamlining it with the STEC culture method. In addition, it will explore the use of molecular screening methods, which are not currently approved for this sample type for Salmonella. Finally, it will employ the use of metagenomics to understand culture dynamics as well as Salmonella serovar diversity to help improve the isolation of all serovars present in this complex sample matrix. This improvement will help during regulatory activities to much more quickly find the serovar/strain of interest during public health events.

Principle Investigator: Burall, Laurel

Location: Human Foods Program (HFP) MOD-1, 8301 Muirkirk Road, Laurel, MD (In-Person)

Objective:

1. Evaluate the efficacy of various post-harvest treatments, such as boiling and UV light, to reduce the amount of Listeria monocytogenes on enoki mushrooms after harvest.
2. Contaminate mushrooms at different points during cultivation determine if earlier or later contamination events alters the efficacy of the treatments at harvest or consumption.
3. Evaluate whether storage post-treatment alters the assessment of the treatment’s efficacy by determining whether bacteria grow or return to detectable levels, depending on initial treatment efficacy, during the standard shelf-life.

Project Needs and Duration:

Prior experience working in a research environment, especially with Listeria monocytogenes, is preferred. Basic science coursework and lab instruction. Additionally, basic laboratory experience, including pipetting, ability to make calculations for reagent and solution preparation, serial dilutions, genomic DNA isolation, sequencing library preparations is preferred.

The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

Listeriosis outbreaks have been linked to the consumption of contaminated enoki mushrooms. Post-outbreak evaluation has noted differences in the practices associated with enoki consumption based on region. Additionally, several post-harvest treatments have been proposed to reduce Listeria monocytogenes on the product but full understanding of the efficacy of these treatments, especially how timing of contamination may affect treatment efficacy, is limited. This project will evaluate several proposed interventions, including UV light, organic acid treatment, and different heating protocols, to determine their effectiveness and whether or not contamination timing alters the efficacy (i.e., contamination at harvest versus during mushroom generation).

Principle Investigator: Chen, Yi

Location: Human Foods Program (HFP), Wiley Building, 5001 Campus Drive, College Park, MD (In-Person)

Objective:

Evaluation and validation of revised qPCR assay and cultural analysis protocol for updating the FDA Bacteriological Analytical Manual (BAM).

Evaluation of alternative rapid screening and identification assays for Cronobacter.

Project Needs and Duration:

Course work and preferably lab course work in microbiology. Prior work experience in a microbiology lab preferred. The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

Cronobacter is a rare cause of invasive diseases, including bacteremia, meningitis, and necrotizing enterocolitis. Infants younger than 2 months old are at highest risk. The organism is able to survive in low moisture foods, such as powdered infant formula (PIF), for long periods. In late 2021 and early 2022, a series of Cronobacter spp. illnesses among infants in the U.S. was associated with PIF. FDA inspection of the suspected facility revealed the presence of Cronobacter spp. within the production environment, leading to a voluntary recall. This recall and the temporary shutdown of the facility were a major contributing factor to the infant formula shortage across the U.S. in 2022. This incident highlights the critical need for FDA to enhance the testing of Cronobacter in PIF and its production environment, as well as other samples related to Cronobacter infection investigations. The FDA Bacteriological Analytical Manual (BAM) contains FDA’s preferred laboratory procedures for the detection of Cronobacter in PIF. However, this chapter was last updated more than 10 years ago. Since that update, new enrichment broths, chromogenic agars, qPCR master mixes and rapid identification assays have been developed or updated, some of which might perform better than those in the BAM. In addition, ISO published its Cronobacter standard in 2017 and prescribes a sample size smaller than that in the BAM. Furthermore, Cronobacter has gone through some nomenclature changes since 2012, and thus, the specificity of the BAM screening and identification methods needs to be evaluated. Finally, the testing of Cronobacter is expanding to matrices other than powdered infant formula, such as environmental swabs, nursery water and baby cereal. The current enrichment scheme in the BAM may not be optimal for recovering Cronobacter from these matrices. Therefore, a major update of the BAM is needed for improved testing of Cronobacter and any changes should be subsequently validated.

Principle Investigator: Durigan, Mauricio

Location: Human Foods Program (HFP) MOD-1, 8301 Muirkirk Road, Laurel, MD (In-Person)

Objective:

1. Perform detection methods like qPCR, conventional PCR, and digital PCR on the DNA extracted from environmental samples in Cryptosporidium samples.
2. Perform the Dead-end ultrafiltration on different water sources to compare the recovery on different matrices for Cryptosporidium detection.
3. Perform fresh produce wash methods for Cryptosporidium detection.
4. Contribute to data analysis using currently available bioinformatics tools.
5. Contribute to communication of the research findings by involving in preparations on posters, and manuscripts.

Project Needs and Duration:

1. The student intern should have had at least some General Microbiology courses with labs.
2. The student should have some familiarity in using computer programs other than MS office.
3. The student should have an interest to learn about PCR, qPCR and dPCR.
4. The student should be able to work in the laboratory using different kinds of sample processing, DNA preparation, spiking of samples, and microscopy.

The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

Cryptosporidium spp. is a protozoan parasite from the phylum Apicomplexa that causes the diarrheal disease cryptosporidiosis, a foodborne and waterborne gastrointestinal illness that is distributed worldwide. Approximately 51% of reported global protozoan waterborne diarrheal outbreaks are associated with Cryptosporidium. In 2011, the Centers for Disease Control and Prevention (CDC) considered cryptosporidiosis an endemic disease in the United States and estimated that there are approximately 748,123 cases each year in the United States. Some cases may be foodborne as well, associated with ready-to-eat foods and fresh produce. In 2023, the FDA was notified of an outbreak of cryptosporidiosis in Minnesota among patrons of a taqueria. C. parvum and C. hominis are the most prevalent species causing disease in humans; however, human cases have also been reported on a smaller scale, caused by C. felis, C. meleagridis, C. canis, and C. muris. The current BAM method for recovering and detecting the parasitic protozoa C. parvum and C. hominis from leafy greens and soft fruit is outdated due to discontinuation of equipment and reagents and does not include approaches that can discriminate the zoonotic genotypes. There is a need to update the FDA methods to enhance molecular epidemiology tools for detection of Cryptosporidium genotypes of human concern in food, food contact surfaces, and agricultural water. In summary, this study has two main goals: 1. Update the current FDA method for detection of Cryptosporidium genotypes in food samples and add food contact surfaces; 2. Update the current FDA method for detection of Cryptosporidium genotypes in water samples.

Principle Investigator: Maria Hoffmann / , Jie Zheng

Location: Human Foods Program (HFP), Wiley Building, 5001 Campus Drive, College Park, MD (In-Person)

Objective:

1. Perform knockouts of the tisB, ccm, and kdp gene on the S. Agona genome using λ-Red recombination and knock out the hyc operon in the E. coli O121 genome using the CRISPR system.
2. Conduct phenotypic analyses of mutants to confirm the functional roles of these genes.
3. Conduct RNA-seq analysis of mutants inoculated on cereal at various time points to identify compensatory mechanisms of specific genes under desiccation stress. For the transcriptome study, both long-read and short-read sequencing will be performed to compare the most effective sequencing platform.

Project Needs and Duration:

1. Ability to learn quickly.
2. Fundamental skills in microbiological techniques.
3. Proficient in wet lab expertise, particularly in handling human pathogens and managing a high volume of samples.
4. Familiarity with molecular methods including PCR and agarose gel electrophoresis.

The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

1. Create mutant strains of S. Agona with a specific gene knockout that profoundly affects its ability to survive and persist within a food matrix.
2. Identify the compensatory mechanisms in S. Agona mutants that enable survival in low- moisture environments, even in the absence of major survival genes, using both short- read and long-read sequencing. Compare the sequencing results for insights into these adaptive mechanisms.
3. Prepare a mutant strain of E. coli using CRISPR system to identify the role of specific genes. The CRISPR system will be used only for those genes that cannot be knocked out by λ-Red recombination.

Principle Investigator: Leighna Holt /, Laura Markley

Location: Human Foods Program (HFP) University Station, 4300 River Road, College Park, MD (Hybrid of Remote/In-person)

Objective:

1. Identify and verify Ames positive or equivocal data in FCNs and/or PNCs via advanced search features in FARM/CERES
2. Identify and verify FCSs and their impurities that have positive Ames data to prepare them for batch analysis to be run in ChemTunes and appropriate QSAR models
3. Use ChemTunes to determine the TTC values of these FCSs and impurities
4. Store results in an excel spreadsheet
5. Determine any other relevant toxicity data from CERES to compile with the Ames positive data and empirical data from ChemTunes and the QSAR models
6. Participate in interdisciplinary team meetings and contribute to discussion on the project’s goals and results
7. Prepare findings to be presented to the branch and/or conferences
8. Potentially assist in proposing an internal decision tree of follow-up testing of an Ames-positive FCS and/or its impurities

Project Needs and Duration:

The student should have completed at least one year of toxicology, physiology, or biology (lecture and laboratory) and obtained at least a grade of B. Preference will be given to applicants that have additionally taken courses in chemistry and have computer science knowledge.

The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions. This is a hybrid work opportunity with encouraged “in person” attendance 1 day/week during break sessions.

Description:

This proposal seeks funding to support a student research project in the DFCS/OPMAS/OFCSDSI to evaluate the use of genotoxicity data, specifically positive Ames test results, in the safety assessment of FCSs or their impurities reviewed under Food Contact Notifications (FCNs) and Prenotification Consultation (PNCs).

The overarching purpose of this work is 1) to inform review staff in DFCS/OPMAS of the historical assessment of positive findings in the in vitro bacterial reverse mutation (Ames) test while reviewing safety of food contact substances (FCSs) or their impurities and 2) to provide internal suggestions of follow-up testing utilizing the current genotoxicity battery paradigm to support safety at estimated dietary exposure levels. The intent of this project is not to change or challenge any established policies or current recommendations, or diminish the use of expert judgement in decision making, but rather provide context on existing data to inform policy formulation and future expert analysis.

Background: The Ames test is widely used to detect mutagenic properties in substances. However, the historical regulatory approach of handling FCNs and PNCs with positive Ames results is unclear. This project will investigate how substances with positive Ames test data were considered under Effective FCNs, and if further mutagenicity studies or predictive toxicity data were considered as part of a weight-of-evidence (WoE) approach to determine the safety of food contact substances and their impurities. By analyzing historical FCN and PNC submissions, the student will identify how frequently positive Ames test data are present and explore the subsequent actions taken during regulatory review. The research will provide critical insights into the decision-making process regarding mutagenicity of FCSs or their impurities. This knowledge could inform future decision trees, improve understanding of how New Approach Methods (NAMs) can be integrated into the current safety assessment paradigm, and advance NAMs in the field of food safety.

Principle Investigator: Timme, Ruth

Location: Human Foods Program (HFP), Wiley Building, 5001 Campus Drive, College Park, MD (Remote)

Objective:

Objective 1: The intern will identify isolates collected as part of FDA inspections. We would focus first on FDA swab isolates from food manufacturing facilities, which are easily identifiable in the NCBI database.

Objective 2: The intern will collect or gain access to historical FDA inspection records that are connected to the isolates identified in Objective 1.

Objective 3: The intern will create an approach to standardize these historical records in the format required for the new metadata package, update the historical records at NCBI, and help to implement a new standardized approach for collecting future samples.

Project Needs and Duration:

Students who have experience with/in: Bioinformatics, data science, biology, food science, or microbiology. The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

Pathogen genomic surveillance is an essential component of modern public health and regulatory science, playing a crucial role in ensuring food safety and preventing disease outbreaks. The FDA utilizes genomic technologies to monitor, trace, and mitigate the spread of foodborne pathogens. Central to these efforts is the National Center for Biotechnology Information (NCBI) database that serves as the public repository for the genomic data and associated contextual data.

FDA, in collaboration with partners at CDC, USDA, and NCBI, created a new metadata package that includes an expanded suite of contextual data describing the isolate sources (human, animals, food products, food facilities, or farm/environment). When this new package is fully implemented, FDA will use this package for their food samples, facility inspection samples, and farm inspection samples. This additional metadata will provide critical information for risk assessment activities in an easy to access format.

This project focuses on implementation across the FDA laboratories at FDA/HFP/ORTS. During this phase, we have faced unique challenges. The bacterial isolates collected by FDA from facility inspections have a significant amount of crucial collection information connected with them, but this information is not standardized and difficult for laboratorians translate into standard formats.

This project will focus on standardizing historical collection data from FDA inspections. FDA inspectors document and photograph where they’re swabbing on the collection report then submit this information as a PDF document. This information is not always documented in a standard way or easy to extract from the collection report pdf where it then needs to be digitized and converted to a standardized format in order to implement the new contextual data package.

Our goal with this project is to organize existing FDA inspection documentation for relevant isolates into a standardized dataset.

After compiling the standardized dataset of inspection information for isolates collected as part of FDA inspections, we will add this information to the NCBI BioSample database, thereby dramatically increasing the value of these isolates to public health officials and researchers across the U.S.

Principle Investigator: Carter, Jake

Location: Human Foods Program (HFP) Wiley Building, 5001 Campus Drive, College Park, MD (In-Person)

Objective:

1. Learn applied atomic spectroscopy theory to better understand potential pitfalls between different atomic spectrometry techniques and different plasma sources.
2. Learn how to quantitatively prepare samples for atomic spectrometry analysis. Working at trace element concentrations requires more attention and detail than what is taught in general chemistry laboratory experiments. Example: Sample massing, sample transfer to digestion vessels, reagent massing and transfer to digestion vessels, gravimetric dilutions, clean chemistry—working in a clean room environment.
3. Prepare samples spanning the AOAC Food Triangle (i.e. foods with varying amounts of fats, protein, and carbs) for acid extraction. Quantitatively perform microwave assisted digestions of all samples and quality control materials for the project.
4. Prepare external standard calibration curves for quantitative analysis on plasma OES instruments.
5. Perform daily instrument checks and calibrations. Maintain instruments throughout the project (e.g., cleaning plasma torches, changing pump tubing, calibrating instrument spectrometer).
6. Perform instrumental analyses of all validation foods to meet the definition of single lab validation in the Chemical Methods Food Validation Guidelines.
7. Process all instrumental data to convert instrument response to element mass fractions.

Project Needs and Duration:

1. Demonstrated success in quantitative chemical analysis coursework and lab exercises.
2. Research in a lab environment involving quantitative sample preparation and instrumental analysis.
3. Soft skills related to the intern’s ability to operate both in independent work within the lab under the advisor’s guidance and in a team environment within the branch.

The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

EAM 4.4 is a recently updated method covering up to 23 elements in foods using inductively coupled plasma optical emission spectrometry (ICP-OES). Currently undergoing a multi- laboratory validation, EAM 4.4 has been single lab validated and shown to be fit for purpose for regulatory analysis. ICP-OES is a workhorse technique for atomic emission spectrometry with multielement capabilities based on the energy rich, Ar supported plasma.

Recent research has shown novel plasma sources are capable of quantitative atomic emission spectrometry at lower cost. Of note is the microwave-sustained, inductively coupled, atmospheric-pressure plasma (MICAP), where MICAP optical emission spectrometry (MICAP- OES) is tolerant of potentially harsh matrices routinely encountered during food regulatory analyses. Prior results demonstrated suitable accuracy for nutrient elements in organic solvents and high salt solutions. In addition to its ruggedness, the N2 supported plasma leads to lower operational costs compared to the traditional Ar ICP. Therefore, if proved to be suitable for nutrient element analysis via a successful single lab validation, MICAP-OES may be an efficient alternative for regulatory analysis of nutrients in food compared to the traditional ICP-OES instrumentation commonly found in FDA field labs.

OLOAS/OCT/DBC/CCB has recently purchased and installed a MICAP-OES for testing and validation. The data gathered from the project will determine the metrics of performance of the new technique and suitability of the platform for regulatory analysis where accuracy and low uncertainty are required in addition to cost efficiency.

Principle Investigator: Wong, Jon

Location: Human Foods Program (HFP) Wiley Building, 5001 Campus Drive, College Park, MD (In-Person)

Objective:

1. Maintain inventory of pesticide and other chemical standards.
2. Develop high resolution MS/MS libraries and compound databases for pesticides and other chemicals (veterinary drugs and mycotoxins).
3. Develop methods to analyze and screen pesticides in different (primarily low moisture and high fat) food types.
4. Operate LC-MS instruments and process results.
5. Interpret results.

Project Needs and Duration:

1. Good academic standing (preferably sophomore or advanced freshman).
2. Background in science, engineering (preferably science or engineering majors).
3. Strong work ethic, inquisitive, pro-active, comfortable in a laboratory environment.
4. Coursework in general and organic chemistry (though not necessary).
5. Interested in science or engineering.
6. Good computer skills.

The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

One of the roles of the FDA's food safety program is to monitor for the presence of chemical residues and contaminants such as pesticides in foods. The FDA is responsible to enforce pesticide tolerances that are established by the U.S. Environmental Protection Agency. Since there are many pesticides and food types, improvement of current methods or development of methods to identify and quantify these potentially harmful chemicals presents many challenges. This research involves the development of new technology and the expansion of current procedures to new chemicals and food matrices for monitoring and surveillance.

This research will involve the use of liquid chromatography-high resolution mass spectrometry and a non-targeted Data Acquisition for Target Analysis (nDATA) workflow to expand and improve current FDA procedures for the analysis of pesticides and other residues and contaminants (e.g., veterinary drugs, mycotoxins) in FDA regulated products. These applications will result in the improvement or complement existing procedures by providing rugged, rapid, and robust multiresidue methods suitable for FDA and non-FDA laboratories.

Principle Investigator: Zhang, Kai

Location: Human Foods Program (HFP), Wiley Building, 5001 Campus Drive, College Park, MD (In-Person)

Objective:

1. Characterize homogeneity using laser diffraction particle size analysis and real-time image analysis in representative (e.g., cereal grains) and challenging matrix groups (e.g., spices).
2. Perform extension of Compendial Method C-003 to priority commodities for regulatory analysis (e.g., dried fruits, DDGs, tree nuts, confectionary/candy, coffee, tortillas, and spices) and instrument platforms (e.g., 7500+ QTRAP)
3. Develop a method to determine trichothecenes (e.g., nivalenol, deoxynivalenol, 3/15-acetyl- deoxynivalenol, and deoxynivalenol 3-glucoside) in baby cereals using differential ion mobility technology (e.g., SelexIon+).

Project Needs and Duration:

1. Dedication to food safety
2. Interest in food analysis
3. Basic understanding of analytical chemistry

The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

Aligned with the ongoing evaluation of automation, we aim to expand the use of an automated sample preparation platform and incorporate particle size analysis to improve mycotoxin testing in new and challenging matrices. Laborious  sample  preparation  and  insufficient  characterization  of  sample homogeneity are well-known challenges, but often excluded from LC-MS based multi-mycotoxin analysis due to the lack of adequate methodologies. The goal of this study is to develop an automated sample preparation workflow using robotic tools to streamline sample preparation for mycotoxin testing. This study will also evaluate the integration of a rotary sample divider and a laser diffraction particle size analyzer to characterize sample homogeneity in representative and challenging commodities such as cereal grains, peanut butter, dried fruits, confectionary/candy, coffee, tortillas, dried distillers grains (DDGs), tree nuts, and spices. For new matrix groups and instrument platforms, an extension of Compendial Method C-003 will be performed following the FDA Foods Program Guidelines for the Validation of Chemical Methods. Commodities outside of the standard performance range for C-003 will be catalogued and considered for advanced development. In addition to sample and matrix considerations, monitoring the co-occurrence of deoxynivalenol and its metabolites has been an important but underexplored topic. To assess occurrence, the current study will aim to develop new methodology to investigate deoxynivalenol metabolites in cereal grain commodities. Combined, the study will generate scientific data to evaluate the suitability of automated sample preparation, the incorporation of particle size analysis to characterize sample homogeneity, and extension of Compendial Method C-003 to build capacity and support growth of the mycotoxin program.

Principle Investigator: Girmay, Berhane

Location: Human Foods Program (HFP) University Station, 4300 River Road, College Park, MD (Hybrid of Remote/In-person)

Objective:

The intern will continue to research and learn the FARM Data Quality utility and apply this knowledge to:

1. Identify historical records, apply correct metadata and corrections to the records and update in the appropriate folder structure and roadmap.
2. Document the methodology used in the automation and curation process and generate periodic reports summarizing corrections made using the Food Applications and Regulatory Management system (FARM) reporting tools.
3. Identify limitations of FARM utility tools and assist in providing requirements for the enhancement of FARM utility tools using potential automation tools.

The intern will also learn the regulatory processes used by offices of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI), Office of Pre-Market Additive Safety (OFCSDSI-OPMAS), Office of Post-Market Safety (OFCSDSI-OPMA), Office of Dietary Supplement Programs (OFCSDSI-ODSP), OFCSDSI-Innovation Foods Staff, OFCSDSI Operations Staff, and Nutrition Center of Excellence-Office of Nutrition and Food Labeling (ONFL) in the FDA's Human Foods Program (HFP) by interacting with the technical staff, contractors, regulatory and scientific reviewers while performing and supporting the data curation tasks.

Project Needs and Duration:

Computer science with Machine Language emphasis, information technology, or data science related courses that enable the intern to understand information technology applications. The intern will interact with regulatory scientists and contractors to learn and contribute new ideas or methods for the enhancement of the system utility for performing data quality measures.

The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

This project provides an opportunity to learn about an end-to-end regulatory information management system known as the Food Applications and Regulatory Management system (FARM) which houses current and historical, scientific and regulatory food safety data spanning over 60 years. The project will help to update historical regulatory records withcorrect metadata to improve the findability of regulatory and safety information of submissions and documents for use by scientific reviewers in the Human Foods Program (HFP). The project includes performing quality control using the system data correction utility, developing enhancements to the utility tool, documenting methodology, and learning how to generate summary reports. The Office of Food Chemical Safety, Dietary Supplements and Innovation (OFCSDSI), Office of Pre-Market Additive Safety (OFCSDSI-OPMAS), Office of Post-Market Safety (OFCSDSI-OPMA), Office of Dietary Supplement Programs (OFCSDSI-ODSP), OFCSDSI-Innovation Foods Staff, OFCSDSI Operations Staff, and Nutrition Center of Excellence-Office of Nutrition and Food Labeling (ONFL) in FDA's Human Foods Program (HFP) utilize the FARM system as an official regulatory document repository because it captures scientific, regulatory, and administrative information about submissions pertaining to the food additives, food packaging materials, dietary supplements, and health claims. In addition, the system is a repository of correspondence from congress, industry, and citizens as well as Freedom of Information (FOI) requests and responses. The system has gone through several upgrades, and HFP continues to improve and enhance system capabilities and is being used by the FDA’s Office of Chief Scientist-Office of Color and Cosmetics (OCAC) for tracking correspondence and inquiries. FARM system is also enhancing its capabilities to optimize regulatory data management by integrating with other FDA interfacing systems that are used by regulatory review scientists in performing their duties to meet the Food, Drug and Cosmetics Act (FD&C Act) statutory deadlines. The findability of relevant information from historical food safety records is crucial for the HFP’s Pre and Post-Market activities.

Principle Investigator: Petro, Elizabeth

Location: Human Foods Program (HFP), University Station, 4300 River Road, College Park, MD (Hybrid of Remote/In-person)

Objective:

The intern will review inquiries, identify frequently-asked questions (FAQs), draft responses to these FAQs (in collaboration with FDA colleagues with cosmetics expertise, both scientific and regulatory), and respond to inquiries that are not addressed in the FAQs. Consolidated FAQs will also be posted proactively to our web page and used to develop guidance documents to provide better customer service to both consumers and the regulated industry alike. The intern will also refine and enhance the metrics developed in the first year of the project, propose process improvements based on those metrics, and measure the success of process interventions using the new metrics.

Project Needs and Duration:

The ideal intern will have strong communication skills and a science/public health background such that the individual will be able to recognize patterns, handle competing priorities, and be very curious and ask many questions. The estimated duration of the internship project is one year. Time requirements include 8-10 h/week during the school year and 30 h/week during break sessions.

Description:

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily. With the passage of this new law, we have received an influx of questions from consumers and the regulated industry alike to our Food and Cosmetics Information Center (FCIC) and to our QuestionsAboutMoCRA@fda.hhs.gov email addresses. These questions have provided insights into areas of the law that need further clarification and eventual guidance, as well as letting us know some of industry’s concerns regarding implementation of many of the provisions. In addition to providing customer service to these inquirers, these inquiries provide valuable data, which, when analyzed, will allow FDA to better prioritize use of its limited public health resources. In the 2024-2025 project, we developed metrics and implemented certain process improvements. For the 2025-2026 project, we will refine and enhance the previous metrics using a new process, and measure the success of process interventions using these new metrics.