Agriculture, food, and related industries represent 5.4% of US gross domestic product (GDP) and 10.5% of all US jobs.

US agricultural policy is framed mostly by the Farm Bill, which is standing legislation that governs farm and food and nutrition programmes and policies. The Farm Bill must be renewed at least every five years by Congress. Other federal, state, and local governing bodies, judicial systems, and agencies also impact US agricultural policy (see The Agricultural Law Section, Milestones in Agricultural Law, Md. B.J., December 2021, at 124).

The US participates in several international agricultural organisations, including the:

Several programmes providing financial compensation to support farms and agriculture in the US are run by the US Department of Agriculture (USDA), a federal government agency. Different types of financial support are housed within different agencies of USDA and are listed below. The financial support programmes listed below are authorised and reauthorised primarily in the Farm Bill. Eligibility requirements vary by programme and should be carefully reviewed.

The Risk Management Agency (RMA) manages federal crop insurance options for farmers. Policies can cover fruits and vegetables, field crops (corn, soybeans, and so on), and certain livestock and animal products and grazing lands. The insurance policies cover a farmer's loss in the event of a natural disaster or weather event and during declines in revenue due to market conditions. Private companies (Approved Insurance Providers) sell crop insurance under USDA policies and the USDA pays for some of the total premium cost, with farmers paying the rest.

The Farm Services Agency (FSA) offers financing options including direct loans and loan guarantees to farmers and a number of other programmes to financially assist with natural disasters (including support for uninsured crops), other financial risks, organic certification, and retiring land from farming. Farmers can also access loans from the Farm Credit System (FCS), a private lender established by federal law with a mandate to serve farmers, some agribusinesses, and others.

Racial discrimination in USDA lending programmes led to multiple lawsuits against USDA, which resulted in settlements and payments to African-American, Hispanic, and Native American farmers, as well as a gender discrimination case settlement for women farmers.

The Natural Resources Conservation Service (NRCS) provides farmers with funding to instill conservation practices on their farm operations.

Rural Development (RD) offers loans, grants, and loan guarantees to both farms and food and agricultural businesses in rural areas. These grants and loan opportunities include support for value added farm products, renewable energy, and meat processing establishments.

There are also programmes to provide education and research for agriculture in the US through the following USDA agencies and institutions:

There is also the Foreign Agricultural Service, which enforces existing trade agreements, establishes international standards, and maintains markets for the exports of US agricultural products. Trade agreements usually govern exports.

Environmental regulation of agriculture in the US is mostly through federal and state law but county and municipality requirements may also apply. Most states have a Department of the Environment that assists with enforcing these regulations at state and federal level. The Environmental Protection Agency (EPA) is the federal agency that drafts environmental regulations and assists with enforcing them.

While most agriculture is exempt from these environmental regulations, farms and agricultural businesses should carefully review whether they are exempt, including from the:

Agriculture in the US contributes to and is harmed by environmental issues, including climate change, water quality and supply, soil health, and other issues. Climate change is significantly impacting US agriculture and food production through extreme weather events, invasive species and pests, and other impacts that have killed livestock, reduced yields, and destroyed crops.

The NRCS (see Question 2) provides financial support for farmers working to address some of these environmental issues and to help them comply with relevant environmental regulations. Farm specific programmes include the Environmental Quality Incentives Program, Conservation Stewardship Program, Agricultural Conservation Easement Program, and the Conservation Reserve Program (CRP is administered by FSA, not NRCS). These programmes are often tailored to each state's resource needs, through State Conservation Practice Standards.

USDA also has a new programme, the Partnerships for Climate-Smart Commodities, which is specifically focused on climate change and agriculture.

Zoning law governs what land can be used for agricultural purposes, and is usually regulated by a local jurisdiction, such as a city, town, or county. Land use restrictions may be implemented to preserve agricultural land and prevent nearby land uses that could conflict with nearby farm operations (section 33:2. Agricultural zoning, generally, 4 Am. Law. Zoning § 33:2 (5th ed.)).

Farmers and ranchers can apply for a permit to graze livestock on federal land with the Bureau of Land Management (BLM).

Agriculture in the US is governed and regulated by federal, state, and local governments.

Under Article VI of the US Constitution federal law is "the supreme law of the land." Essentially, this means that if there is a law impacting agriculture at federal level, a state law cannot conflict with it.

The commerce clause in Article I, Section 8, Clause 3 of the US Constitution also creates jurisdictional lines for agricultural regulations. Generally, if an agricultural product is sold across state lines, or is not sold across state lines but has a substantial and economic effect on interstate commerce, it may be regulated by the federal government (see Wickard v. Filburn, 317 U.S. 111 (1942)). Therefore, the federal government often has primary regulatory authority over agriculture.

If the product is sold within state lines, production of that product can usually be regulated by the state if a state government chooses to do so (see, for example, raw milk sales). However, if the federal government is not regulating a certain activity in agriculture (that is, there are no preemption concerns), and a state law attempts to regulate it, courts may still decide that the law goes too far, and is not valid if the law unduly burdens or discriminates against interstate commerce (that is, there is a violation of the "dormant commerce clause").

State laws can also preempt local laws. For example, some state laws have preempted a local zoning ordinance by exempting specific agricultural activities from these ordinances (§ 33:4. Agricultural exemptions, 4 Am. Law. Zoning § 33:4 (5th ed.)).

Numerous federal agencies regulate agriculture, including the EPA, the USDA, the US Department of Labor, and the Food and Drug Administration (FDA). Sometimes the state government and state Departments of Agriculture may be involved in the regulation of agriculture, even if it is a federal law. For example, the federal government may delegate their regulatory authority to the state for certain agricultural laws, such as environmental laws (see, for example, the National Pollutant Discharge Elimination System (NPDES) permit and on-farm food safety inspections.

Business entities in the US are formed and regulated primarily under state laws. Farms in the US are typically structured as sole proprietorships, partnerships, or limited liability companies. Some operations form as corporations, and there are agricultural co-operatives. Farms can be for-profit or non-profit businesses.

Sole proprietorships are the simplest type of business entity. There are no start-up formalities. It is run by one person who is responsible for all the business' benefits and risks. The owner reports the business' income or loss on their personal Federal tax return. The business dissolves on the owner's death.

A partnership is a type of business structure with two or more people involved. There are three types of partnerships: general partnership, limited partnership, and limited liability partnerships.

A general partnership is formed when two or more people simply agree to run a business. General partners share equally in all the business' assets, profits, and liabilities, and the partnership dissolves when any one of the partners leaves. Partners are taxed on their personal Federal tax returns for their portion of the partnership's profits and losses, and so on.

A limited partnership has a general partner who has unlimited legal liability and any number of other partners who have limited liability. Matters of control over the company in a limited partnership are documented in a partnership agreement.

Limited liability partnerships are similar to limited partnerships in that profits and losses pass through to the partners and each includes their share on their personal Federal tax return.

A limited liability company (LLC) protects its owners (members) from personal liability. Members can be individuals, other businesses, or other legal entities like trusts. There can be an unlimited number of members. There can also be a single-member LLC. An LLC is a formal business arrangement requiring filing articles of organisation with the state. In some states, the LLC is dissolved when a member leaves or a new member joins, unless there is an agreement that clearly states how to buy, sell, or transfer ownership of the LLC. Unless members elect to be treated as a corporation, the IRS will treat an LLC with at least two members as a partnership for Federal income tax purposes or, for a single-member LLC, as a disregarded entity, meaning the business' income and expenses go on the member's personal Federal tax return, like a sole proprietorship.

A corporation typically provides the strongest liability protection for its owners. It is a legal entity and its owners (shareholders) are not personally liable for the corporation's debts. A corporation can be created by one shareholder or by a group of shareholders, and shareholders can be individuals as well as other legal entities. Most corporations seek to return a profit for their shareholders, but some corporations are not-for-profit.

Most states now also recognise "benefit corporations" or "B corps", a for-profit corporation that seeks to provide a public benefit as well as returning a profit for its shareholders.

Forming a corporation requires filing articles of incorporation in the state in which the corporation will be incorporated, as well as adhering to the state's regular governance and reporting requirements. Corporations can raise funds through stock sales, and the company can continue to do business despite shareholders selling their shares in the company. Publicly traded corporations, which can have thousands of shareholders, are also regulated by the US Securities and Exchange Commission (SEC). "Close corporations" in most states have less formalities. They are smaller companies and typically are barred from publicly trading stock.

Most for-profit corporations are taxed on their profits and their shareholders are taxed when the corporation distributes dividends. Some corporations also file with the Internal Revenue Service (IRS) to seek special tax status under the US Internal Revenue Code (IRC) (for example, "S corporations" or "S corps") to avoid "double taxation" and allow profits and some losses to pass to shareholders' personal income without being taxed at federal corporate tax rates.

Non-profit corporations must file with the IRS for tax-exempt status. They are often referred to as "501(c)(3) corporations" because that is the section of the IRC under which most corporations are granted tax-exempt status.Section 501(c)(5), however, specifically provides exempt status to labour, agricultural, or horticultural organisations (26 U.S. Code §501(c)(5)).

Co-operatives are becoming more common in the US in the agricultural sector. Agricultural co-operatives are organisations owned and operated by farmers or producers who join together to market their products, purchase supplies, or provide services collectively.

For-profit co-operatives return excess profits to their members in the form of patronage dividends. The allocation and apportionment of patronage dividends varies among members depending on the co-operative's bye-laws and operating agreements. For federal tax purposes, patronage dividends received from agricultural co-operatives are treated as taxable income or non-taxable income, depending on certain criteria outlined in Subchapter T of the IRC and related regulations:

Not-for-profit co-operatives, or co-operatives that experience a loss in a particular year, provide members with patronage refunds. A patronage refund is a refund of a portion of the money that members paid for goods or services during the year. Patronage refunds are typically paid in two parts: one part cash and a second part capital retained by the co-operative held in the farmer's account. The farmer will usually receive a Form 1099-PATR from the co-operative. A copy of the Form 1099-PATR is also provided to the IRS.

Typically, a co-operative is run by an elected board of directors and officers, although regular members have a say in the direction of the co-operative. Members can become part of the co-operative by purchasing shares. The amount of shares held by a member does not affect the weight of their vote.

One important benefit of farmer co-operatives is an exemption from federal antitrust laws (see Question 8) under the Capper-Volstead Act, so long as the co-operative operates for the mutual benefit of producers of agricultural products and does not deal in the products of non-members in an amount that exceeds the value of the products that it handles for its members. Co-operatives cannot engage in restraint of trade.

Currently, there are no restrictions under federal law on foreign investment and ownership in the US agriculture sector. Restrictions have been proposed in Congress and may come up in future Farm Bill debates. SeeForeign Ownership of US Agriculture: Selected Policy Options and Who Owns the FARM: Foreign Investment in US Agriculture.

There is currently no bar at federal level to a foreign investor acquiring a US agricultural business, nor is any special prior government approval required. However, there are reporting requirements if the acquisition concerns agricultural land in the US, and there may be restrictions at state level (see Question 9).

In addition, restrictions have been proposed in Congress (see Question 6).

The Agricultural Foreign Investment Disclosure Act of 1978 (AFIDA) (P.L. 95-460,7 U.S.C. §§3501-3508), as implemented by USDA, requires all foreign persons and entities who acquire or transfer an interest in agricultural land to provide information to the USDA Farm Service Agency county office where the land is located using anAFIDA Report Form FSA-153 within 90 days of the date of acquisition or transfer (7 C.F.R. § 781). The form (Form 153) is available in English and Spanish and is on the USDA Service Center eForms website.

"Agricultural land" is land used for forestry production, farming, ranching, or timber production (7 U.S.C. 3508; 7 C.F.R. §781.2).

A "foreign person" includes "any individual, corporation, company, association, partnership, society, joint stock company, trust, estate, or any other legal entity" (including any foreign government) created under the laws of a foreign government or with a principal place of business outside the US, and US entities in which there is a significant foreign interest or substantial control (7 U.S.C. 3508).

The following information must be reported:

In case of a disposition, the party disposing of the interest must also give the legal name and address of the buyer.

Any change in the legal name or address of the foreign person and other entities disclosed on the report form must also be reported within 90 days of such changes.

Failure to disclose can result in a civil penalty of up to 25% of the fair market value of the interest held in the land (7 C.F.R §781.4). After the original disclosure, each subsequent change of ownership or use must be reported. See also Foreign Ownership and Holdings of US Agricultural Land.

Although USDA and the Department of Health and Human Services (HHS) are not current members of the US Committee on Foreign Investment (CFIUS), under section 721 of the Defense Production Act of 1950, as amended (DPA), as implemented by Executive Order 11858, as amended, and the regulations atchapter VIII of title 31 of the Code of Federal Regulations, CFIUS may consider foreign investment transactions in the food and agriculture sector, and the US Treasury may designate USDA and HHS as co-leads in a CFIUS investigation on a case-by-case basis (50 U.S.C. § 4501 et seq.). In September 2022, President Biden instructed CFIUS to consider "elements of the agriculture industrial base that have implications for food security" among other factors to consider relating to a transaction's effect on US technological leadership in areas affecting US national security (Executive Order 14083, 15 September 2022). For information about legislation proposed to add the agricultural sector to CFIUS and to consider the agricultural industry as a matter of national security, see Question 6.

There is no separate anti-trust regime for the agriculture sector. Generally, the US Department of Justice (DOJ) and the US Federal Trade Commission (FTC) jointly oversee anti-trust enforcement in the US. They investigate mergers and acquisitions, collusive practices, monopolistic behavior, unfair methods of competition, deceptive practices, and other anti-competitive conduct.

The following competition and anti-trust laws apply to all industries, including agriculture:

In addition to these federal statutes, most states have similar anti-trust laws.

No federal law prohibits ownership of agricultural land by non-citizens or corporations, but there are reporting requirements for non-citizens (see Question 7).

Most states allow non-citizens to own land.

A few US states have restrictions on the ownership of farmland by non-citizens and by US corporations. A few examples are listed below but this is not an exhaustive list, and several states are debating legislation to change these laws:

Agricultural land is generally owned or leased in the US and is governed primarily by state law.

Ownership of land can be through joint tenancy, tenancy in common, tenancy by the entirety (in some states), and transferred via an estate plan or gift, or a sale of the land.

There are some restrictions on corporate and foreign ownership of farmland in the US (see Question 9).

After the forced removal and dispossession of Tribes from their lands, the US entered into treaties with the Tribes that described property ownership on Tribal lands, which was usually held by the Tribe. However, the General Allotment Act of 1887 forced Tribes to move towards individual property ownership in Indian Country without any compensation for the loss of tribal lands. The Indian Reorganization Act of 1934 ended this shift, but issues remain for land ownership in Indian Country, including trust administration and land fractionation. Some of this land is held in trust by the US government, and the government still has the legal title to the land, while an individual or Tribe has beneficiary interests, meaning they can only use and profit from the land, but cannot sell, lease, mortgage, or transfer a property interest in the land without the government's approval. There are also restricted lands, where an individual or Tribe has legal title to the land, and it can be sold, mortgaged, or transferred under US law, which may impose other legal restrictions (Angelique Townsend EagleWoman & Stacy L. Leeds, Mastering American Indian Law Chapter 2 (2013)).

Conservation easements, which are legal contracts, might also exist on agricultural land that prevent the sale of the land for non-agricultural purposes.

State law generally governs leases on agricultural land, and may cover termination, subleases, rights to harvest after lease expiration, and other topics.

The BLM provides leases for ranchers wishing to use federal land (see Question 4).

Some states restrict non-citizens and corporations from leasing agricultural land, with some exceptions (see Question 9).

The Uniform Partition of Heirs Property Act (UPHPA) is an example of the approval procedures required in some states for the sale of agricultural land that is heirs' property.

Heirs' property happens when one or more generations die without a will, and the heirs receive a tenancy in common interest in the land, meaning they can transfer or sell their interest in the land without the consent of other tenants in common. This can make sharing interests in farmland that is heirs' property difficult, and has even included the forced sale of farmland, which has contributed to Black land loss (see Gaining Ground: The Fight for Black Land and Historic Partition Law Reform: A Game Changer for Heirs' Property Owners).

To address this issue, 22 states have passed the UPHPA which requires that:

A partition in kind divides the property between the multiple owners so other owners do not have to sell their share of the property, compared to a partition by sale, where the property is all sold, and co-owners are given the proceeds from their sale based on their interest in the property. If the court decides a partition-in-kind will prejudice the owners, the property is offered for sale at the court determined fair market value, unless another process is more fair for the owners.

There are no mandatory minimum land prices for agricultural land.

The fifth amendment of the US constitution allows the government to take privately owned agricultural land for public use for just compensation through eminent domain.

State law regulates most water use in the US. For surface water, the Riparian Doctrine is usually the law in most eastern states and the Prior Appropriation Doctrine is the law in most western states (The Evolving Nature of Water Rights as Property Rights in the United States).

In summary, the Riparian Doctrine is the ownership of water extending to all waters that border the owner's private land, and that person can use and access that water so long as the use is reasonable, and the water is not diverted in a manner that would impact access to that water body by another rightful owner (see The Evolution of Riparianism in the United States).

A brief summary of the Prior Appropriation Doctrine is when water rights are given to the first person to put that water body to beneficial use. More junior water users can still use that water body but will be asked to halt their water use in favour of the more senior users in times of water scarcity (ownership of land abutting that water body is not necessary under this doctrine) (see Prior Appropriation: Rule, Principle, or Rhetoric).

There is also the Public Trust Doctrine for any publicly owned water, which usually covers maintenance of lakes and streams and prohibits private ownership of land that reaches the oceans and seas.

Groundwater is also regulated by the states, and includes a wider range of possible laws and doctrines that govern its use, including the Correlative Rights or California rule, the Reasonable Use Doctrine, the Subflow Doctrine, and the Templeton Doctrine, among others (see Water Law 101: Part 4, Groundwater Terms and Definitions).

Here are two different state examples of how each system may require permits or licensing for certain types of water use.

Arkansas law follows a "regulated riparian" system. The Riparian Doctrine is followed for surface water but regulations exist for certain conditions. The reasonable use standard in the Riparian Doctrine or a version of the Correlative Rights Doctrine is followed for groundwater. The Arkansas Department of Agriculture's Natural Resources Division regulates water-use in specific instances. Any person using more than 325,851 gallons of surface water or non-domestic users of more than 50,000 gallons of groundwater must register with the Natural Resources Division and there is specific registration for agriculture. There are also non-riparian water use permits for those without a riparian right but who still want to use that water.

In Arizona, surface water is regulated under the Prior Appropriation Doctrine and permits are issued to reserve these water rights by the Arizona Department of Water Resources (ADWR). Groundwater is subject to the Reasonable Use Doctrine via the Arizona Ground Water Code, and permits are required that vary by location. Under the Winters Doctrine, an Indian Reservation has rights to the water on the date the Reservation was established. The quantity of water issued to the tribe for agricultural purposes is based on the practicably irrigable acreage or a reasonable number of farm acres with irrigation.

Depending on how the farmland is owned, who owns the farmland, and how it is transferred or sold, there may be several tax implications to consider, including federal and state capital gains tax, estate tax, and in a few states, inheritance tax.

Federal capital gains tax applies a 0% to 20% tax on gains on sales of farmland (the amount of the sale less what the owner paid for the land) if that farmland has been owned for at least one year. If the land is owned for less than one year, the gain on the sale is taxed at the ordinary income tax rate. Those who inherit the land through an estate plan transfer automatically "step up" the capital gains "basis" amount, so that the original purchase amount is the current fair market value price of that land for capital gains tax purposes. If they sell that land right away, they may avoid paying any capital gains tax. Several states also have capital gains tax.

If the farmland is transferred through an estate plan to an heir, federal estate taxes may apply. However, there are very high exemptions amounts and farmland valuation can be reduced through the special-use valuation for some farmland, which allows it to be valued at farm-use and not fair market value.

A few states also have estate and/or inheritances taxes.

The federal government (see Question 2) and private lenders may finance the purchase of agricultural land via a mortgage. See FSA Handbook: Direct Loan Making and FSA: Your Guide to FSA Farm Loans.

Farmers also take out loans to purchase equipment, livestock, and so on.

State law governs the lender's security interest in the collateral that secures the loan, including a mortgage. Most state laws are the same or similar and are based on the Uniform Commercial Code (UCC), and Article 9 governs personal property.

Special provisions within Article 9 are specific to agriculture, including agricultural liens that automatically attach to farm products, which can include crops and livestock, to secure financing for goods or services for the farm operator or to pay for rent for that farmland. There are also additional provisions for agriculture, such as special choice of law provisions and certain priority provisions.

USDA's Animal and Plant Health Inspection Service (APHIS) is the primary agency responsible for regulating the import of new plant species or varieties and crop-growing technologies. It has promulgated Plant Protection and Quarantine (PPQ) regulations under the authority of the Plant Protection Act (PPA) (7 U.S.C. § 7701 et seq.) to regulate the importation of plants and plant products.

Under the PPQ, permits are required to import regulated plants and plant products for consumption or propagation, including timber, cotton, and cut flowers, "plants for planting such as nursery stock, small lots of seed, and postentry," fruits and vegetables, "protected plants and plant products such as orchids, and threatened and endangered plant species." Controlled import permits are required to import prohibited plant materials for research.

A phytosanitary certificate may also be required to ensure the plant material is pest- and disease-free. Information about applications for permits is on the USDA website.

The permits usually require the plant species, point of origin, intended use, and sometimes photographs or samples and pest risk analysis. Links to information about import requirements, federal import orders, accreditation, and certification programmes for plant imports, agriculture quarantine and inspection, and offshore plant health safeguarding activities are available on the USDA website.

The online system to apply for import permits is APHIS eFile.

Imported seeds and plants must enter through plant inspection stations and be declared to US Customs and Border Protection (CBP), within the US Department of Homeland Security. There are 16 plant inspection stations in the US. The National Plant Germplasm Inspection Station in Beltsville, Maryland, can inspect small amounts of plant germplasm for plant breeding and research purposes.

At the inspection stations, CBP Agriculture Specialists verify that the permits and documentation are valid, and APHIS PPQ Officers may conduct an inspection to ensure compliance with regulations, the PPA, the ESA, and CITES (see Question 24). If any issues are identified, the plants may be subjected to post-entry quarantine, treated, denied entry, re-directed to a non-FRSMP State, restricted in interstate movement, or destroyed, depending on the specific Federally Recognized State Managed Phytosanitary (FRSMP) programme requirements determined appropriate for the specific pest or disease. APHIS may also issue an Emergency Action Notification (EAN, PPQ Form 523) to the importer explaining the importer's options and providing a link to theFRSMP programme website, where the importer can find detailed information about the specifically required mitigations.

The FRSMP programme allows for pests to be re-categorised to no longer require action at entry into the US. Information about the process for recategorising pests is on the USDA website.

The List of Pests No Longer Regulated at US Ports of Entry is on the USDA website. Some pests are still actionable at ports in Hawaii, Puerto Rico, or the US territories of Guam, the US Virgin Islands, American Samoa, Federated States of Micronesia, Midway Islands, Northern Marianas Islands, Republic of Palau, and the Republic of the Marshall Islands. For inquiries about a pest's status at ports in specific US territories, email [email protected].

Information about the US Regulated Plant Pest List is on the USDA website, including the US Regulated Plant Pest Table and the list of Pests Regulated under a Federally Recognized State Managed Phytosanitary Program.

The APHIS Agricultural Commodity Import Requirements (ACIR) database is a search engine for fruit and vegetable imports. It can be searched by commodity for import requirements and to see if a permit is required. APHIS' eFile system for permit, licence, and registration applications uses the ACIR import requirement data when processing plant and plant product permit applications.

Steps to initiate a commodity import request for a fruit, vegetable, plant, or plant product that is not already an approved commodity are set out on the USDA website. The list of approved commodities is on the USDA website.

A list of commodities currently undergoing a pest risk assessment is on the USDA website.

The US is a contracting party to the IPPC.

Approvals and/or licences required for setting up R&D centres and test plots for new crops depend on the type of crop, the plot location, the activities being conducted, and how the crop is intended to be used.

Crops that involve the use of pesticides or genetically modified organisms (GMOs) may require specific approvals from the EPA. Typically, this requires providing data on the crop's safety, any potential environmental impacts, and adherence to regulatory requirements. Test plots for genetically modified crops (see Question 22) may require working with USDA's Biotechnology Regulatory Services to ensure compliance with applicable laws and permits. Information about APHIS' Biotechnology Quality Management Support Program is on the USDA website.

In addition, it is necessary to contact the Department of Agriculture for the state where the test plots will be located. They may have additional regulations or require additional permits or licences.

It is also necessary to check with the local county or city government to determine whether any permits or approvals are required for conducting agricultural research or setting up test plots.

APHIS and/or the EPA may need to approve or receive notice of crop or seed production, and individual states or municipalities may have their own requirements (see above, R&D Centres and Test Plots for New Crops).

APHIS and/or the EPA might need to approve or receive notice of commercial crop or seed production, and individual states or municipalities might have their own requirements (see above, R&D Centres and Test Plots for New Crops).

APHIS and/or the EPA may have to issue a permit for interstate movement of seeds or crops. Individual states may have additional requirements for the sale of products (see above, R&D Centres and Test Plots for New Crops).

The federal Plant Variety Protection Act (PVPA) protects novel and distinct varieties of sexually reproduced or tuber-propagated plants (7 U.S.C. §§ 2321-2583). Protection is granted to individuals who breed, develop, or discover the varieties.

Under the Plant Variety and Protection Regulations, a breeder can obtain a plant variety certificate from the Plant Variety Protection Office, part of the USDA's AMS. The protection gives the breeder the ability to prohibit others from selling, reproducing, exporting, importing, or developing a hybrid or different variety of the certified plant (7 C.F.R. §§ 97.1-97.900).

The variety which the breeder is seeking to certify must be:

(7 U.S.C. § 2402.)

Unlike the PVPA, the Plant Patent Act protects breeders' rights by granting them control over new, living plant varieties, other than tuber-propagated plants, that can be produced through asexual reproduction. This includes natural plants, "sports, mutants, hybrids," transformed plants, algae, and macro fungi.

The protection gives the patent holder the right to exclude others from asexually reproducing the plant, and from using, offering for sale, or selling the plant so reproduced, or any of its parts, throughout the US, or from importing the plant so reproduced, or any parts thereof, into the US (35 U.S.C. §§ 161-164).

Plant patents cannot be obtained in varieties that reproduce sexually. Protection is available for "sports" that occurred naturally as long as those sports were discovered in the cultivated area. Plant patent protection cannot be obtained for plants that are not found in cultivated areas. Plant patents are not available for tuber-propagated plants.

The variety for which plant patent protection is claimed cannot have been made available to the public more than one year before applying for the patent.

Although algae and macro-fungi are considered plants for which plant patent protection is available, bacteria are not considered plants for the purposes of plant patent protection.

The US has ratified the UPOV Convention and all its amendments.

To obtain a plant variety certificate, the breeder (an individual person, not an entity) must submit a detailed application to the Plant Variety Protection Office setting out the characteristics of the variety, breeding history, basis for their ownership, and other evidence of how the variety is distinguished from others.

In some cases, variety samples must also be submitted with the application.

There is a fee to apply for the certificate and, if the application is approved, there is an additional fee required to issue the certificate. There is no annual fee to maintain the certificate.

To obtain a plant patent, a person who has invented or discovered a new and distinct plant variety can apply to the US Patent and Trademark Office (USPTO) for a plant patent.

The inventor must detail the variety's genus, species, variety denomination, and botanical description. They must also provide a clone (an asexually reproduced plant variety) and show that it can be successfully reproduced by asexual reproduction.

A specific aspect of a plant (such as a single gene, genetic sequence, trait, or method of genetic engineering) can be protected through a utility patent granted by the USPTO.

Like a plant patent, a utility patent grants the breeder protection against third party reproduction, sale, or use of the patented gene, sequence, trait, process, or method (35 U.S.C. § 101 et seq). To obtain a utility patent, an inventor must submit an application to the USPTO very similar to a plant patent application.

A plant or utility patent provides exclusive protection for 20 years from the date of the first application for the patent.

Generally, plant variety certificates provide protection for 20 years from the date they are issued. Certificates for trees or vines provide protection for 25 years (7 U.S.C. § 2483).

Plant variety certificates are only available to US nationals, except where that would violate a treaty to which the US is a party. The US will also grant reciprocal protection to a foreign national that is afforded to a US applicant in the foreign country for the same genus and species (7 U.S.C. § 2403).

A certificate owner can lose the protection if the government determines that protection must be rescinded to protect the supply of fiber, food, or feed in the US. In this case, the owner is entitled to compensation for rescission of the protection (7 U.S.C. § 2404).

Third parties are permitted to use and reproduce protected varieties for breeding or other bona fide research without infringing on the rights of an owner's plant variety certificate (7 U.S.C. § 2544). However, any third party wishing to sell, offer for sale, reproduce, import, export, or use a protected variety to produce a hybrid or different variety must contact the breeder for consent before conducting such activity, otherwise the third party may be deemed to have infringed on the breeder's rights of protection granted under the certificate (7 U.S.C. § 2483).

There is no farmer's privilege for varieties protected by patents. However, a farmer can save enough seed from a certified protected variety to plant their own farm. They cannot, though, sell excess seed of protected varieties. In addition, a grain handler who cleans seed of a protected variety on behalf of a farmer who is not authorised to plant it can, along with the farmer, be liable for infringement.

Under applicable law, a farmer who receives a licence from, or is otherwise permitted by, a certificate holder to produce or sell the seed of a certified variety can also save the seed for replanting and sell saved seed to other farmers. This right to save seed for replanting or to sell to other farmers is known as a "crop exemption" (7 U.S.C. § 2543 and Asgrow Seed Co. v Winterboer et al., 513 U.S. 179 (1995)). A farmer must generally negotiate the terms of the licence/permission to use the seed for commercial purposes directly with the certificate holder before they can benefit from the crop exemption.

If a plant variety certificate is infringed, the certificate owner can sue the infringing party in civil court. The certificate holder can seek an injunction to stop the infringement and/or money damages (7 U.S.C. §§ 2561, 2563).

The certificate holder is entitled to actual damages caused by the infringement, interest, and costs, including attorney fees (7 U.S.C. § 2564).

US policy on GM crops is broadly summed up in the federal government's Coordinated Framework for Regulation of Biotechnology (CFRB) (51 Federal Register 23302, 26 June 1986).

Within the CFRB, the USDA, FDA, and EPA focus their regulatory authority on the products of genetic modification versus the processes used to create them and apply existing statutes to assess the safety of biotechnology products.

The CFRB was most recently updated in 2017. The update includes summaries of the various statutes and regulatory processes related to the EPA, FDA, and USDA's authority to regulate biotechnology products. It also states that EPA, FDA, and USDA welcome and encourage developers of biotechnology products to contact the agencies at the early stages of product discovery or development so any questions related to regulatory status, safety, and/or effectiveness can be identified and adequately addressed (Modernizing the Regulatory System for Biotechnology Products: Final Version of the 2017 Update to the Coordinated Framework for the Regulation of Biotechnology).

Within the CFRB, USDA's APHIS and Food Safety Inspection Service (FSIS) each have authority over the regulation of agricultural biotechnology products:

APHIS authorities derive primarily from the PPA, Animal Health Protection Act (AHPA, 7 U.S.C. §8301 et seq.), and Virus-Serum-Toxin Act (21 U.S.C. §151 et seq.).

FSIS authorities derive from the Federal Meat Inspection Act (FMIA, 21 U.S.C. §601 et seq.), Poultry Products Inspection Act (PPIA, 21 U.S.C. §451 et seq.), and Egg Products Inspection Act (EPIA, 21 U.S.C. §1031 et seq.).

FDA authorities derive from the Federal Food, Drug, and Cosmetic Act (FFDCA, 21 U.S.C. §301 et seq.) and Public Health Service Act (PHSA, 42 U.S.C. §201 et seq.).

EPA authorities derive from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA, 7 U.S.C. §136 et seq.).

In December 2022, the Office of Science and Technology Policy (OSTP) published a Request for Information inviting comments to assist in identifying any regulatory ambiguities, gaps, inefficiencies, or uncertainties in the CFRB, particularly with regard to new and emerging biotechnology products. Information provided to the OSTP will inform regulatory agency efforts to improve the clarity and efficiency of regulatory processes for biotechnology products. The comment period closed on 3 February 2023.

The US is not a party to the Cartagena Protocol on Biosafety.

Biotechnology permits. APHIS regulates the importation, interstate movement, and field testing of GE plants and organisms that are or might be plant pests pursuant to its authority under the PPA.

The PPA, part of the umbrella Agriculture Risk Protection Act of 2000 (Pub. L. 106-224), regulates the movement of plants, plant pests, noxious weeds, and other related organisms (7 U.S.C. §§ 7701-7772). It works with the Genetically Engineered Plant Pest Regulations, which restrict the introduction of bio-engineered organisms that are, or could potentially be, plant pests (7 C.F.R. §§ 340.0-340.9).

Specifically, GE plants that are or might be plant pests are considered "regulated articles" under APHIS regulations (7 C.F.R.340-340.9). APHIS authorisation must be obtained prior to import, interstate movement, or environmental release, including field testing.

More specifically, a "regulated" plant cannot be introduced into the environment, or even field tested, unless its developer obtains APHIS authorisation through the permit process or notification process.

Permits impose restrictions on movement and planting to prevent escape of plant material that may pose a pest risk. Sponsors follow APHIS guidance on testing and movements to ensure that the plant will not damage agriculture, human health, or the environment. Plant-based pharmaceuticals virtually always must be developed under the permit process. However, most other GE crops have been developed under the notification option, an expedited procedure less rigorous than permitting. Notification can be used instead of permitting when the plant species is not considered a noxious weed (or weed in the release area) and other APHIS standards are met.

Regardless of the process chosen, after testing is completed, a developer next seeks "non-regulated status" from APHIS, the typical route to full commercialisation and no further formal oversight. The developer must provide APHIS with extensive information on plant biology and genetics, and potential environmental and plant pest impacts that may result from the modification. APHIS conducts a formal environmental assessment (EA) under the National Environmental Protection Act (NEPA) and has public comment periods before deciding whether to approve the developer's request for "non-regulated status." A determination of non-regulated status ends further federal regulatory oversight of the GE plant.

Information about APHIS' Biotechnology Regulatory Services is on the USDA website.

Information about APHIS' Biotechnology Regulatory Service's Permitting and Notification Process is on the USDA website.

A BRS Notification or Permit can be applied for on the USDA website.

USDA plant requirements. The USDA "SECURE" rule (Sustainable, Ecological, Consistent, Uniform, Responsible, Efficient rule (7 C.F.R. § 340) (18 May 2020)), in effect for all genetically engineered (GE) plants as of 1 October 2021, revised USDA's regulatory approval process for GE plants and organisms to reduce the regulatory burden for developers of organisms that are unlikely to pose plant pest risks.

Under the SECURE rule, the USDA exempted broad categories of new plants from review based on APHIS' current understanding of associated plant-pest risks. The Congressional Research Service's In Focus Report,USDA's SECURE Rule to Regulate Agricultural Biotechnology, CRS In Focus Rep, IF-11573 (12 June 2020), summarises the rule and new regulatory process.

See also the Congressional Research Service's (CRS) Report,Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues, CRS R46737 (29 March 2021).

USDA animal requirements. APHIS has authority under the AHPA to restrict or prohibit the importation, exportation, transportation, or environmental release of any live animal, including GE animals, to protect against the introduction and spread of pests and livestock diseases (7 U.S.C. §8301 et seq.).

AHPA defines animal pests to include protozoa, plants, bacteria, fungi, viruses or viroids, infectious agents or other pathogens, arthropods, parasites, prions, vectors, and any other organisms that injure livestock.

APHIS can require post-import quarantine as needed to prevent the introduction of disease. Domestically, APHIS can quarantine or destroy livestock as required. Warrantless searches of livestock entering the US are authorised and, if there is probable cause, searches of those moving in interstate commerce and those in a quarantine area. All other searches require warrants.

APHIS is responsible for administering the permit programme to import controlled materials, animal products, cell cultures, live animals, semen and embryos, and veterinary biologics (see Question 24). Although regulation of GE animals may fit in this permit system, APHIS has not used it for that purpose, other than for GE insects.

APHIS also has authority to regulate animal biologics (viruses, serums, and toxins for animal vaccines), including GE-derived biologics, under the Virus, Serum, and Toxins Act, to ensure they are pure, safe, potent, and effective (21 U.S.C. 151 et seq.). APHIS licenses veterinary biologics and has continuous oversight over them.

The FFDCA and the PHSA authorise the FDA to regulate plants, animals, and other organisms produced with biotechnology to ensure they do not pose a risk to human health.

FDA plant requirements. The FDA treats most foods derived from GE plants as "generally recognised as safe" (GRAS), unless the product or products (such as proteins, carbohydrates, and fats) that the plant expresses due to GE changes differ significantly in structure, function or composition from substances found currently in food (FDA, Statement of Policy - Foods Derived from New Plant Varieties, 57 Federal Register 22984, 29 May 1992).

Foods and feeds from GE plants must undergo a special review if they would be used to host an industrial or pharmaceutical substance, or if the change introduced through genetic engineering produces unexpected genetic effects, changes nutrients or toxicant levels, or might introduce a new allergen.

FDA encourages sponsors of foods and feeds derived from GE plants to participate in its voluntary Plant Biotechnology Consultation Program. For more information, see FDA Consultation Programs on Food from New Plant Varieties.

In June 2006, FDA published guidance providing that developers of new plant varieties intended for food use, including those that are genetically engineered, can provide FDA with any information about new proteins they are using in the early stages of crop development (FDA, Recommendations for the Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use, 71 Federal Register 35688, 21 June 2006).

This Early Food Safety Evaluation Program (also known as a New Protein Consultation) is designed to take place earlier in the development process than a voluntary plant biotechnology consultation and before the stage of development when a new protein might "inadvertently" enter the food supply. FDA designed this early consultation to address the possibility that field testing of GE crops, through cross-pollination with other crops, could inadvertently introduce small amounts of proteins into the food supply that FDA has not evaluated (such as potential toxins or allergens).

FDA animal requirements. FDA has regulated GE animals under the new drug provision of the FFDCA (21 U.S.C. §360b) since issuing final guidance on the topic in 2009.

The 2009 policy identifies the regulated article (the new animal drug) as the rDNA construct in a GE animal that is intended to affect the structure or function of the body of the GE animal, regardless of the intended use of products that may be produced by the GE animal. That is, the DNA inserted into the animal's genome through genetic engineering is considered a new animal drug.

Developers of GE animals and GE derived animal products must obtain FDA new animal drug approval before these animals and products can be marketed and sold. In 2017, FDA issued draft guidance for industry on the Regulation of Intentionally Altered Genomic DNA in Animals. This updates the prior guidance, in which the regulated article was the recombinant DNA construct, to define the regulated article as the intentionally altered genomic DNA. FDA describes intentional genomic alterations (IGAs) as including genetic changes introduced through biotechnology techniques that use recombinant DNA, as well as those techniques that do not. This guidance expands FDA oversight of GE animals to include those derived from genome editing. It also clarifies that FDA intends to exercise enforcement discretion, including its intention not to enforce certain requirements for animals of non-food producing species that are regulated by other government agencies, are raised and used in contained and controlled conditions, or are other cases based on FDA evaluation of risk factors. Such GE animals include GE insects regulated by APHIS, GE laboratory animals, and, in a specific example, GloFish (aquarium fish genetically engineered to fluoresce).

FDA has also addressed the regulation of animal cloning. In 2008, FDA released a final risk assessment and industry guidance on the safety of meat and milk from cloned cattle, pigs, and goats, as well as their offspring. This guidance found that such products are as safe to eat as those of conventionally bred animals. FDA also concluded that cloning poses the same risks to animal health as those found in animals created through other assisted reproductive technologies, although the frequency of such problems is higher in cloned animals. FDA does not require pre-market approval of food products from cloned cattle, swine, or goats or their offspring (see Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues (CRS R46737).

The FDA encourages potential developers to consult with them early in the development process if they have any questions about whether the FDA believes the IGAs in the animals they are developing are sufficiently low risk so that the FDA does not expect an approval application or, if they do, what type of data the FDA expects to support the application.

For more information about the FDA's regulation of GMOs, see Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues (CRS R46737).

For the most recent industry guidance (GFI 187) from the FDA on the regulation of GE animals, seeGuidance for Industry: Regulation of Intentionally Altered Genomic DNA in Animals, Draft Guidance, FDA, Center for Veterinary Medicine (January 2017).

For information on the FDA's regulation of IGAs in animals, including elements of the approval process described in GFI 187, see Q&A on FDA Regulation of Intentional Genomic Alterations in Animals | FDA.

In January 2021, USDA and the HHS signed a memorandum of understanding (MOU) agreeing to establish new USDA regulatory programmes for pre-market and post-market review of "amenable species" developed using genetic engineering and intended for agricultural purposes (human food, fiber, and labour).

The USDA agreed to use its authorities under the APHA, FMIA, and PPIA. FDA committed to continuing its regulatory oversight of genetic engineering in animals for non-agricultural purposes and certain other products, including dairy, table, and shell eggs, and certain meat products. USDA and FDA committed to working together to achieve comprehensive regulatory oversight. The MOU provides that USDA will provide oversight of animals modified or developed through genetic engineering for human food from pre-market reviews to post-market food safety monitoring. FDA will continue its review of intentional genomic alterations intended not just for agricultural use but also for biopharma and non-heritable genetic alterations. The agencies intend to transition the FDA's pre-existing animal biotechnology regulatory responsibilities to USDA.

The EPA regulates the development, testing, manufacture, sale, and use of all pesticides through its authority under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), 7 U.S.C. §136 et seq., including those incorporated into plants through genetic engineering, also known as plant-incorporated protectants (PIPs), to determine their environmental safety.

The EPA requires prior notification for small-scale field tests of PIPs, although it can exempt small-scale trials where the organism is contained. For larger field tests, the EPA requires the developer of the organism or product intended to be used as a pesticide to obtain an experimental use permit (EUP).

Under NEPA, an EA or environmental impact statement (EIS) is required for any field trials or commercial uses of GMOs where living organisms are released into the environment. Testing designed to avoid or limit environmental risks can be excluded from NEPA requirements.

Manufacturers of all pesticides, including PIPs, must register pesticide products with the EPA before marketing them.

For more information on the EPA's regulation of GMOs, see Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues (CRS R46737).

The FDA and the USDA are the primary federal authorities responsible for ensuring that foods sold in the US are properly labelled, meaning no false or misleading labelling.

FDA labelling requirements for GE foods. The FDA requires labels of GE foods to identify:

USDA labelling requirements for GE foods. The National Bioengineered Food Disclosure Standard (NBFDS) (P.L. 114-216) was enacted in 2016. It pre-empted all state GMO labelling laws in the US and mandated GE labelling, or on-package disclosure, of GE foods or food ingredients.

Under the NBFDS, in 2018, the USDA's AMS promulgated regulations requiring on-package disclosure of bioengineered foods or food ingredients. Foods that meet criteria in the NBFDS must display the bioengineered (BE) symbol. Foods that do not meet the criteria but derive from bioengineered foods can display the "derived from bioengineering" symbol. Disclosure can also be made via written text on the label, electronic or digital link, or text message.

The NBFDS does not apply to certain meat, poultry, egg, or refined products that do not contain detectable modified DNA. Certain foods are exempted from the NBFDS, including food served in restaurants, food produced by very small food manufacturers, and food containing bioengineered substances below a threshold amount.

US importers are responsible for ensuring their goods comply with the NBFDS.

For more information about the NBFDS, see Agricultural Biotechnology: Overview, Regulation, and Selected Policy Issues (CRS R46737).

Authority to control the import and export of animals is primarily vested in the USDA and the US Fish and Wildlife Service (USFWS).

Importing live animals into the US typically requires an import permit issued by APHIS. The permit specifies the conditions and requirements for importation, including health certificates, quarantine procedures, and specific regulations for certain species.

Animals imported into the US must be accompanied by a health certificate issued by a licensed veterinarian in the country of origin verifying that the animal is in good health and meets specific health requirements, such as vaccination records and tests for certain diseases. Depending on the species and the country of origin, imported animals may be subject to quarantine on arrival in the US.

Federal regulations governing importing animals and animal products are codified in Title 9, Code of Federal Regulations (9 CFR), Parts 92-98.

Requirements and resources to import animals and animal products are on the USDA website, including a list of regions with temporary restrictions on importation of some animals and animal products.

The US has few requirements for exporting animals to other countries. Federal regulations governing exportation of live animals, hatching eggs, and animal germplasm are codified in Title 9, Code of Federal Regulations (9 CFR), Part 91, Exportation of Live Animals, Hatching Eggs or Other Embryonated Eggs, Animal Semen, Animal Embryos, and Gametes from the United States. Requirements and resources for exporting a live animal, including semen or embryos or animal products, are available on the USDA website.

The federal Endangered Species Act (ESA) regulates the import, export, and trade of endangered and threatened species. The USFWS administers the ESA and issues permits for the import or export of protected species.

The international Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) aims to protect endangered species from over-exploitation through international trade. The US implements CITES regulations through the USFWS, which issues permits for the import and export of CITES-listed species. Information about obtaining a permit is on the USFWS website.

An animal can only be imported into the US through a port of entry. CBP enforces import and export regulations. CBP officers work with USDA and USFWS officials to inspect shipments at ports of entry to verify compliance with all relevant laws and regulations.

The USDA Deputy Administrator of Veterinary Services is the US Delegate to the World Organisation for Animal Health (founded as OIE). The US statement on adoption of specific international standards is on the USDA website.

In the US, the regulatory regime for animal welfare involves a combination of federal and state laws, as well as oversight by various government agencies. The following is a brief outline of the key components.

The federal Animal Welfare Act establishes minimum standards for the treatment and transportation of certain animals used in research, exhibition, and commercial purposes. The Animal Welfare Act ensures the humane treatment of certain non-agricultural animals that are bred for commercial sale, used in research, transported commercially, or exhibited for the public (7 USC §§ 2131-2159). Welfare standards are set out in the Animal Welfare Regulations (see 9 CFR Parts 1-4). APHIS publishes the Blue Book, which consolidates the Animal Welfare Act and the Animal Welfare Regulations requirements.

TheHorse Protection Act prohibits the showing, sale, auction, exhibition, or transport of sored horses. "Soring" is a practice involving the intentional infliction of pain to enhance the horse's gait.

TheHumane Methods of Slaughter Act establishes guidelines for the humane handling, restraint, and slaughter of livestock, excepting poultry.

TheTwenty-Eight Hour Law sets humane standards for transporting livestock. If livestock are being transported for longer than 28 consecutive hours, they must be offloaded for at least five consecutive hours to get feed, water, and rest.

The USDA's APHIS is responsible for enforcing federal animal welfare laws. APHIS conducts inspections, issues licences, and promotes compliance with animal welfare regulations.

The FDA oversees the use of animals in research, particularly for pharmaceutical and biomedical purposes. The FDA ensures that research involving animals follows ethical guidelines and ensures animal welfare.

The Centers for Disease Control and Prevention (CDC) monitor and regulate the importation of animals and animal products into the US to prevent the spread of diseases that can affect both animal and human health.

Each state has its own animal cruelty laws that vary in scope and detail. They typically cover animal abuse, neglect, abandonment, and related offences. State law enforcement agencies, local animal control departments, and humane societies enforce these laws.

Livestock genes, as well as, for example, new, novel, and non-obvious selective animal breeding methods, reproductive technologies, genetic engineering techniques, genetic editing technologies, innovative diagnostic tools, and genetic testing or screening methods are patentable in the US under the Patent Act as a utility patent (35 U.S.C. § 101 et seq).

Discovery of a gene can be the basis for a patent on the genetic composition isolated from its natural state and processed through purifying steps that separate the gene from other molecules naturally associated with it.

Where the patent application discloses a specific, substantial, and credible utility for the claimed isolated and purified gene, the isolated and purified gene composition may be patentable.

An isolated and purified DNA molecule that has the same sequence as a naturally occurring gene is eligible for a patent because either:

A patent on a gene covers the isolated and purified gene but does not cover the gene as it occurs in nature. For further information, see the USPTO Utility Examination Guidelines.

Valuable and confidential animal breeding methods, formulas, or proprietary techniques could also be protected as a trade secret as long as reasonable steps are taken to keep the information confidential.

In the US, various legal and practical restrictions apply to the introduction of new animal breeds or species into the country depending on the type of animal and why it is being introduced.

The restrictions are primarily implemented and enforced by federal and state agencies, including USDA's APHIS, USFWS, and state departments of agriculture and natural resources.

An import permit may be required from the relevant federal or state agency to introduce a new breed or species of animal after showing compliance with specific requirements such as certificates of health or vaccinations, quarantine periods, or inspections (see Question 24).

The Animal Welfare Act ensures the humane treatment of certain non-agricultural animals that are bred for commercial sale, used in research, transported commercially, or exhibited for the public (7 USC §§ 2131-2159) (see Question 25).

Two main federal government agencies govern food safety laws in the US. The USDA's FSIS regulates all businesses that process meat, poultry, and processed eggs. The FDA regulates all businesses that pack, receive, hold, process, or manufacture all other foods not covered by USDA, and farms that grow certain produce items.

State and local Departments of Public Health often regulate restaurants, stores, and other food service institutions.

FDA enforces several food safety laws, including the two main food safety laws, the Federal Food, Drug, and Cosmetic Act and the Food Safety Modernization Act which gave FDA authority to conduct on-farm inspections of certain produce farms.

The main food safety laws that FSIS enforces are the Federal Meat Inspection Act, the Poultry Products Inspection Act, and the Egg Products Inspection Act.

FDA and USDA's implementation of these laws often starts with rulemaking. Both agencies solicit feedback from the industry through public comment periods, listening sessions, and farm or facility visits.

With both FDA and FSIS, states are sometimes the inspection authority (see What are the nine states that have Talmadge-Aiken plants?, State Inspection Programs, and the FDA-State Produce Safety Implementation Cooperative Agreement Program).

The USDA's AMS also offers voluntary food safety audits to farm and food businesses.

State and local food safety laws may be more expansive than federal food safety laws.

The US is a member of the Codex Alimentarius Commission. The US Codex Office is in the USDA's Trade and Foreign Agricultural Affairs area.

State tort law determines what legal requirements are necessary to establish liability for food producers and manufacturers if food causes harm to consumers. Product liability is the most common legal action taken in foodborne illness outbreak cases. Claims might include:

A farmer could be held criminally liable by the government if they fail to comply with the Food, Drug, and Cosmetic Act.

Compliance with federal food safety laws could reduce a farmer's liability if there is a foodborne illness outbreak that is traced back to their farm. Compliance proves that the producer is meeting the standard of care, although this will depend on state law.

Other defences may include:

(See Analysis of Jury Verdict Data for Foodborne Illness, Product Liability and Microbial Foodborne Illness, AER-799, Economic Research Service/USDA and Understanding Foodborne Illness Civil Liability.)

The types of damages available to an injured plaintiff (claimant) depend on state law, but usually include money paid to the individual for the loss or injury caused by the food product. Some states may also include punitive damages, which are meant to punish the defendant.