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A Guide to Meeting Food Manufacturing Regulatory Requirements in New York State

Do you manufacture, process, pack or hold food products and have questions about what you need to do to be in compliance with New York State and federal regulations?

If your answer is yes, then you may find this document useful. It contains several resources that may help you better understand what you need to do to meet regulatory requirements as a food facility operating in New York State. This is by no means a comprehensive list of all resources available, but should point you in the right direction.


Registering New York State Food Facilities, Products, & Businesses

Available Circulars (NYS Food Safety Rules and Regulations)

Guidance for NYS Food Safety Rules and Regulations for various types of food products/businesses and the related inspection/licensing services pertaining to them.

New York State Home Processor Registration Information Sheet

Details the products that can be commercially produced in a home kitchen and NYS requirements for this type of operation.

Food Establishment Licenses

Describes the following food businesses that require NYS licensing and links to the necessary applications: Food Processors, Retailers, Warehouses, Food Salvagers, Refrigerated Warehouses/Locker and Rendering Plants.

Dairy Businesses

NYS Licensing, inspection, and documentation requirements for any business which deals with milk or milk products from production to consumption (cow, goat, and/or sheep milk).

Maple Syrup and Honey

Requirements and Standards of Identity for NYS Maple Syrup and Honey.

Current Guidance: Manufacture & Sale of Kombucha

NYS requirements for producing and selling kombucha wholesale or retail (includes hazard analysis).

Resources for Food Businesses

Industry information on a variety of food safety topics including processes, sanitation, training, and posters.

FDA & NYSDAM Registration & Licensing Forms; Scheduled Process Forms

Quick links to FDA & NYS product and facility registration forms and applications.


Facility Registration for Federal Compliance

Registration of Food Facilities and Other Submissions

Contains links to registration forms, guides, tutorials, and updated FSMA guidance for the food industry.

Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Seventh Edition), August 2018

Updated information about requirements and exemptions for FDA facility registration and renewal.

Small Entity Compliance Guide: Registration of Food Facilities, May 2018

Details requirements and exemptions for registering a food facility with the FDA.


Federal Regulations for Food Businesses and Specific Products

General:

FDA Food Code

Details updated information on Federal Regulation for all aspects of operating a retail food business, including food service and the preparing of safe food.

FDA & NYSDAM Registration & Licensing Forms; Scheduled Process Forms

Quick links to FDA & NYS product and facility registration forms and applications.

Meat, Egg Products, & Siluriforms:

USDA Food Safety and Inspection Service: Small and Very Small Plant Outreach

Resource for USDA inspected products (e.g. meat/poultry, egg products, siluriforms) and current related regulatory information.

Low Acid Canned Foods and Acidified Foods:

Acidified & Low-Acid Canned Foods Guidance Documents & Regulatory Information

Guidance and resources for registering manufacturing facilities and products that fall under acidified or low-acid classification.

Establishment Registration & Process Filing for Acidified and Low-Acid Canned Foods (LACF)

Forms and instructions for registering products and facilities that fall under acidified or low-acid classification and specific requirements and conditions of these products according to the Code of Federal Regulations.


Resources for FDA's Food Safety and Modernization Act (FSMA; Pronounced "Fizz-muh"); Preventive Controls for Human Food Rule

General Regulation:

Food Safety Modernization Act (FSMA)

Comprehensive information on rules, guidance, training, technical assistance, and compliance/implementation tools.

Code of Federal Regulations Title 21 Part 117: FSMA – Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

Actual regulatory language of the FSMA Preventive Controls for Human Food Rule.

Preventive Controls for Human Food Rule (PCHF)

Resources and guidance explaining FSMA’s PCHF Rule including compliance dates, requirements, technical assistance, and more.

Final Rule on Preventive Controls for Human Food at a Glance

Short summary of FSMA’s PCHF rule in plain language.

FSMA Compliance for Small Businesses:

Small Entity Compliance Guide: What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, November 2016

Guidance related to FSMA requirements and exemptions for small businesses/qualified facilities.

Guidance for Industry: Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food And Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals, September 2018

Instructions and forms for determining small business status as a “qualified facility” under FSMA regulation.

Qualified Facility Attestation

Instructions for submitting required forms that attest to the status of a business as a “qualified facility” under FSMA regulation.

Guidance for Industry: Determining the Number of Employees for Purposes of the “Small Business” Definition in Parts 117 and 507, June 2019

Information pertaining to the determining that status of a facility as a small business related to the number of people employed by.

FSMA Operational Requirements: Preventive Controls, Hazard Analysis, & Food Safety Plans:

Food Safety Preventive Controls Alliance (FSPCA) Resources

Resources and industry guidance related to Preventive Controls and FSMA requirements.

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, January 2018

Guidance for developing a Food Safety Plan in compliance with FSMA Regulation.

Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Recall Plan, 2019

New chapter on developing a recall plan in compliance with FSMA’s PCHF rule.

Guidance for Industry and FDA Staff: Questions and Answers Regarding MandatoryFood Recalls, November 2018

Answers to common questions that may arise during a mandatory food recall.

Food Safety Plan Builder

Online tool to assist and guide food manufacturers through the process of creating a food safety plan in compliance with PCHF rule.

Guidance for Industry: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling and Consumer Protection Act of 2004 (Edition 4); Final Guidance, October 2006

Guidance in defining allergens in food products and regulatory requirements related to the Food Allergen Labeling and Consumer Protection Act.

FSMA Regulation for Fresh Produce:

FSMA Final Rule on Produce Safety

Details on FSMA requirements for produce being sold to the public including: compliance dates, exemptions, variances, environmental impact, technical assistance, inspections, and related guidance and resources.

Draft Guidance for Industry: Guide to Minimize Food Safety Hazards of Fresh-cut Produce, October 2018

Information regarding cGMP requirements and PCHF requirements in an operation that manufactures, processes, packs, or holds fresh-cut produce.

FSMA Regulation for Low-Acid Canned Foods:

Guidance for Industry: Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act, August 2017

Guidance related to FSMA regulation for low-acid canned foods.


HACCP Plans (Hazard Analysis and Critical Control Points)

HACCP Principles & Application Guidelines

Guidelines and Principles needed to develop a HACCP Plan.

Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act, September 2017

Juice HACCP Plan; regulatory requirements and related FSMA exemptions.

Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act

Seafood HACCP Plan; regulatory requirements and related FSMA exemptions.

Retail & Food Service HACCP

Manual for voluntary use of HACCP principles in a retail or food service establishment

Dairy Grade A Voluntary HACCP

Current program documents, references, required forms, and worksheets related to creating a HACCP plan at a dairy establishment.


Listeria Controls for Refrigerated or Frozen Ready-To-Eat Foods

Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods, January 2017

Guidance for manufacturers of RTE foods to comply with FSMA’s PCHF rule and cGMP requirements to minimize the risk of Listeria monocytogenes.


Records

Small Entity Compliance Guide: What You Need to Know About Establishment and Maintenance of Records, April 2014

Guidance for record requirements for small business related to FSMA regulation.


Trainings

The Institute for Food Safety at Cornell University fact sheet “Meeting Regulatory Requirements”

Lists trainings offered through the Institute for Food Safety at Cornell University.

Institute for Food Safety at Cornell University GMPs Part 117 Online Course

The Institute for Food Safety at Cornell University offers a Good Manufacturing Practices Course Online that reviews the requirements of 21 CFR Part 117 Subpart B.

Food Safety Preventive Controls Alliance (FSPCA)

Offers courses in Preventive Controls for Human Food, Preventive Controls for Animal Food, Foreign Supplier Verification Programs, and others.

Better Process Control School

List of locations that offer Better Process Control School for Acidified and Low-Acid Foods.

Institute for Food Safety at Cornell University

Offers Food Safety Training Opportunities for Fruits & Vegetables, Dairy Foods, Food Manufacturing, Packing and Processing, and Regulatory Requirements.

Produce Safety Alliance

Links to Produce Safety trainings throughout the country.

National Good Agricultural Practices Program at Cornell University

Offers online and in-person trainings.

Cornell Dairy Foods Extension Program

Offers individual and certificate programs for science, sanitation and regulation of various dairy foods as well as meat foods.

National Dairy Food Safety Coalition

2-day food safety plan coaching workshop for artisan dairy producers.


Regulatory Services for Products

Cornell’s Food Venture Center Fact Sheet

Lists Regulatory services offered by Cornell’s Food Venture Center Process Authority.

Processing Authorities by State

List of states that have process authority services available.