APHIS Factsheet

Policy and Program Development December 2012

Questions and Answers: 

The Rulemaking 

Process

Q. What is a rule or regulation?

A. A rule or regulation is a set of requirements that 

has the force and effect of law. Federal agencies 

issue rules or regulations to implement laws passed 

by Congress that authorize or direct the agency to 

take certain actions. These laws are often referred to 

as an agency’s statutory authority. 

Federal agencies may issue regulations only within 

the scope of their statutory authority. The U.S. 

Department of Agriculture’s (USDA) Animal and Plant 

Health Inspection Service (APHIS) has authority 

under a number of laws, but our primary statutory 

authorities include: the Animal Health Protection Act 

(AHPA), the Animal Welfare Act (AWA), the Horse 

Protection Act (HPA) and the Plant Protection Act 

(PPA). 

•	 The AHPA, passed in 2002, authorizes APHIS to

 regulate the importation and interstate movement 

 of animals and animal products to prevent 

livestock pests and diseases from being 

introduced into or spreading within the United 

States. 

•	 The AWA requires that basic standards of care

 and treatment be provided for certain animals 

bred and sold for use as pets, used in research, 

 transported commercially, or exhibited to the 

 public. The AWA became law in 1966 and has 

 been strengthened several times by amendments. 

•	 The HPA prohibits horses subjected to a practice

 called soring from participating in shows, sales, 

 exhibitions, or auctions. Congress passed the 

 HPA in 1970 with the goal of eliminating this cruel 

 and inhumane practice that is used to accentuate 

 a horse’s gait (i.e., soring). 

•	 The PPA became law in 2000 as part of the

 Agricultural Risk Protection Act. It authorizes 

 APHIS to regulate the importation and interstate 

 movement of plants, plant products, biological 

 control organisms, noxious weeds, and plant 

pests to prevent plant pests or noxious weeds 

from being introduced into or spreading within 

the United States. 

Q. What is rulemaking and what steps are 

involved in it?

A. Rulemaking is a thorough process that provides 

opportunity for the public to provide input on 

regulations before they are finalized. The process 

includes various steps to ensure that regulations 

are sound and consistent with applicable laws and 

policies. While the steps may vary, at APHIS they 

generally involve:

•	 Conducting risk, economic, and/or environmental

 analyses, as appropriate, and drafting a proposed 

 rule.

•	 Reviewing the draft proposed rule within USDA

 to ensure technical accuracy, legal sufficiency, 

 and consistency with policy. In certain cases, a 

rule may also be reviewed by the Office of 

 Management and Budget (OMB), an office within

 the Executive Office of the President of the 

United States.

•	 Publishing the proposed rule in the Federal

 Register, a daily publication of the U.S. 

Government. 

•	 Accepting written comments on the proposed

 rule from the public.

•	 Reviewing the public comments and determining

 what changes, if any, should be made to the 

 proposed rule in response to the comments.

•	 Drafting, reviewing, and publishing a final rule in

 the Federal Register that summarizes and 

 responds to the public comments, makes any 

 necessary changes to the proposed rule, and 

 sets a date for when the rule will take effect.

Q. How long does rulemaking take? 

A. Rulemaking can take from several months to 

several years, depending on a number of factors. 

These factors include the complexity of the issues 

involved; the availability of data needed for economic, 

risk, or environmental analyses; the extent of public 

participation in the rulemaking, and the number 

and nature of comments received; the priority of the 

rulemaking relative to other agency rulemakings 

under development at the same time; and whether 

the rule requires OMB review. Some rulemakings 

also require consultations with State and local 

governments and Indian tribes.

United States Department of Agriculture • Animal and Plant Health Inspection Service • Safeguarding American Agriculture
The Typical Rulemaking Process in 

APHIS 

Step 1: The Proposed Rule

Q. What is a proposed rule?

A. A proposed rule is a document that sets out 

potential new regulations or changes to existing 

regulations that an agency is considering under its 

statutory authority, along with an explanation of why 

the new or revised regulations are appropriate. A 

proposed rule may be accompanied by analyses that 

examine the risks the rule is intended to address, 

the likely economic effects of the rule, and any 

environmental impacts associated with the rule. A 

proposed rule does not have the force of law. It may 

be changed in response to public comments and 

must be published as a final rule before any changes 

to the regulations can become effective and be 

enforced. 

Q. Why does APHIS prepare risk assessments 

and what types of things do they assess?

A. APHIS’ statutory authority is often tied to 

risk. For example, under the PPA, APHIS can 

prohibit or restrict the importation or movement in 

interstate commerce of any plant or plant product 

if we determine that the prohibition or restriction 

is necessary to prevent the introduction or 

dissemination of a plant pest or noxious weed into 

or within the United States. Similarly, under the 

AHPA, we can prohibit or restrict the importation or 

movement in interstate commerce of any animal or 

other article if we determine that the prohibition or 

restriction is necessary to prevent the introduction or 

dissemination of any livestock pest or disease. 

APHIS conducts risk assessments as necessary to 

determine whether movement of an article presents 

a risk of introducing or disseminating a plant pest, 

noxious weed, or livestock pest or disease. APHIS 

may also conduct risk assessments to examine the 

efficacy of measures that could be applied to mitigate 

that risk. 

Q. Why does APHIS conduct environmental 

analyses?

A. The National Environmental Protection Act (NEPA) 

requires all Federal agencies to consider whether any 

of its actions, including regulations, may significantly 

affect the quality of the human environment. APHIS’ 

NEPA process is a separate decisionmaking 

process that is done in conjunction with rulemaking. 

APHIS and other agencies may need to prepare an 

environmental analysis to determine the overall level 

of environmental impacts from its actions. 

Q. What kinds of environmental analyses might 

APHIS prepare?

A. Many rulemaking actions by APHIS pose no 

significant environmental impacts and are, therefore, 

categorically excluded from further environmental 

analysis. APHIS usually prepares an environmental 

assessment (EA) to comply with NEPA when agency 

actions require more in-depth environmental review. 

EAs usually provide a basis for determining whether 

an action is likely to have any significant impacts on 

the environment. If we determine that significant 

impacts to the environment are likely to occur, we 

prepare an environmental impact statement, which 

involves a more comprehensive analysis. 

Q. Why does APHIS conduct economic analyses?

A. APHIS conducts economic analyses because 

Presidential Executive Orders 12866 and 13563 

require Federal agencies to assess the costs and 

benefits of certain rules and to select an approach 

that maximizes benefits. In addition, the Regulatory 

Flexibility Act requires agencies to examine the 

potential economic effects of rules on small 

businesses, nonprofit organizations, and small 

governmental jurisdictions. 

Q. What rules does OMB review?

A. OMB reviews all rules that it designates as 

“significant” in accordance with Executive Order 

12866. Significant rules are those that may have 

a high economic impact, conflict with the actions 

of another agency, alter the budgetary impact of 

Government programs, or raise novel legal or policy 

issues. For most rules, OMB has 90 days to conduct 

its review. 

Step 2: The Comment Period

Q. How is the public informed of the rulemaking 

process? 

A. APHIS publishes proposed rules in the Federal 

Register, which are available to the public online at 

www.regulations.gov. We also use a variety of other 

means to inform the public, such as the APHIS Web 

site, press releases, stakeholder registries, email 

listserves, and, in some cases, public meetings.

Q. What is the comment period for a proposed 

rule?

A. The comment period is the duration of 

time—starting with the date a proposed rule is 

published in the Federal Register—during which 

anyone may comment on a rule. Comment periods 

are typically 60 days, but they may be longer or 

shorter as circumstances warrant. Any comments 

received during the comment period are considered 

United States Department of Agriculture • Animal and Plant Health Inspection Service • Safeguarding American Agriculture
part of the legal record for the rule and will be 

reviewed and considered by APHIS prior to finalizing 

the rule. APHIS accepts written comments submitted 

electronically through www.regulations.gov and via 

postal mail. 

In some cases, APHIS may also hold public hearings 

on proposed rules. Oral comments made at those 

hearings are transcribed and made part of the formal 

rulemaking record, along with all written comments 

received. 

Q. Do I have to formally submit my comments 

during the comment period or can I just call 

APHIS to talk about the proposed rule? 

A. You must submit comments to APHIS through 

the formal process described above. You may 

speak with APHIS officials to ask factual questions 

about a proposed rule (for example, does the 

proposed rule apply to all parts of this plant or only 

to fruit?). However, in order to ensure fairness and 

transparency in the rulemaking process, USDA 

prohibits private written and oral communication 

between USDA officials and outside parties 

regarding the merits of a proposed rule between the 

time a proposed rule and final rule are published. 

Comments supporting a rule, objecting to a rule,

or requesting changes to a rule must be submitted 

through the formal process. 

Q. What type of comment is likely to result in 

changes to a proposed rule?

A. There is no formula for drafting a comment that 

will result in changes to a proposed rule. However, 

comments that identify specific concerns and explain 

the reasons for those concerns are useful to APHIS 

and are more likely than unsupported objections to

result in changes. The following are examples of the 

types of comments that may result in changes:

•	 Comments providing specific reasons why

 provisions of the proposed rule will be difficult to 

comply with or implement. 

•	 Comments proposing alternatives that will be

easier to implement or comply with or that will be 

at least equally effective but less costly.

•	 Comments indicating how provisions of the 	 	

proposed rule substantively duplicate or conflict 

with existing regulations.

•	 Comments providing scientific evidence 	 	

that raises questions about the basis for certain 

provisions of the rule.

Comments that object to provisions of a proposed

rule without explaining why the provisions should be 

changed or removed do not provide APHIS a basis 

for changing a proposed rule. 

Step 3: The Final Rule

Q. What is a final rule? 

A. A final rule finalizes all or some of the provisions 

of a proposed rule. It also summarizes and responds 

to issues raised by commenters during the comment 

period and indicates whether and how the agency 

is changing the proposed rule in response to 

comments. The final rule may differ significantly from 

the proposed rule or may not differ at all. Final rules 

have the force of law.

It is worth noting that not all proposed rules result 

in final rules. An agency may withdraw a proposed 

rule and either take no further action or issue a new, 

revised proposed rule for public comment. 

Q. When do final rules take effect?

A. When publishing a final rule, agencies must 

specify the date it will become effective. Typically, 

final rules take effect 30 days after publication. That 

being said, some final rules—such as those likely 

to have significant economic effects or require 

significant changes to procedures or practices within 

an industry or regulated community—may be made 

effective more than 30 days after publication to allow 

sufficient time to prepare for implementation. In 

addition, final rules may take effect less than 30 days 

after publication if they relieve restrictions or the 

agency otherwise finds good cause and states its 

reason in the final rule.

Other Types of Rulemaking Documents

Q. What is an interim rule?

A. An interim rule is a rule that is effective and has 

the force of law before an agency has considered 

public comments regarding its requirements. In 

APHIS, most interim rules are effective on the date 

they are published in the Federal Register. Unlike 

a final rule, an interim rule is not preceded by a 

proposed rule. 

Because an interim rule goes into effect before we 

consider public comment on it, APHIS may issue an 

interim rule only when there is good cause for us to 

determine that providing this prior opportunity for 

public comment is impracticable, unnecessary, or 

contrary to the public interest. For example, APHIS 

may need to issue regulations effective immediately 

to quickly respond to an outbreak of a plant pest or 

livestock disease.

All interim rules have comment periods that begin on 

the publication date and typically last for 60 days. 

United States Department of Agriculture • Animal and Plant Health Inspection Service • Safeguarding American Agriculture
An agency may make changes to an interim rule 

based on public comments. Such changes are 

typically made in a follow-up final rule. If APHIS 

determines that an interim rule should remain in effect 

without change following the comment period, we will 

publish a document affirming the interim rule without 

change. We call this document an affirmation of 

interim rule. Like a final rule, an affirmation of interim 

rule summarizes and responds to issues raised during 

the comment period.

Q. What is an advance notice of proposed 

rulemaking?

A. An advance notice of proposed rulemaking (ANPR) 

is a regulatory document that APHIS prepares and 

publishes in the Federal Register when we want 

to obtain additional, preliminary information before 

beginning rulemaking. ANPRs usually describe the 

nature of the issue that a proposed rule would seek to 

address and may include a description of regulatory 

options the agency is considering. ANPRs often 

contain specific questions APHIS would like the public 

to answer. ANPRs can help the agency determine 

whether rulemaking is appropriate and identify specific 

issues or concerns that may need to be addressed 

in developing a rule. APHIS may or may not initiate 

rulemaking following an ANPR. 

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United States Department of Agriculture • Animal and Plant Health Inspection Service • Safeguarding American Agriculture