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Animal and Plant Health Inspection Service

Preliminary Regulatory Impact Analysis and Initial Regulatory Flexibility Analysis

Interim Rule: Restrictions on the Importation of Poultry and Poultry Products from 

Regions Affected with HPAI

Docket No. 2006-0074 (06-074-1)

October 25, 2007

INTRODUCTION

Interim Rule. APHIS is amending the current regulations related to highly 

pathogenic avian influenza (HPAI) to include subtypes other than H5N1. Currently, 

HPAI subtype H5N1 is regulated under the U.S. Code of Federal Regulations (9 CFR 

94.6), which is included in the section regulating exotic Newcastle disease (END). These 

regulations prohibit the importation of live poultry and poultry products for human 

consumption from any country where H5N1 is known to exist. However, unprocessed 

carcasses and parts or products of unprocessed carcasses may be imported for scientific, 

educational, or research purposes with the appropriate permit. The subtypes subject to 

regulation under the interim rule will be allowed entry into the United States following 

guidelines similar to those for birds, poultry, and bird and poultry products from 

countries known to have END. APHIS is also adding restrictions to prohibit the 

importation of live poultry and birds that have been vaccinated for avian influenza1

or 

that have moved through regions affected by avian influenza.

2

In addition to regulating additional subtypes of HPAI, the rule will (1) maintain 

the list of HPAI-affected regions on the internet rather than in the CFR; (2) establish the 

conditions, consistent with World Organization for Animal Health (OIE) guidelines for 

notifiable HPAI, under which restrictions can be relieved when a region becomes 

disease-free; and (3) establish a process for relieving restrictions that streamlines the 

regulatory process by allowing APHIS to publish a Federal Register notice, instead of a 

proposed rule, to announce the availability of a document for public comment showing 

that the region has met the conditions for disease-free status.

 

 1 This includes hatching eggs that were laid by birds or poultry vaccinated for avian influenza.

2 This includes hatching eggs.
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In accordance with the requirements of the Office of Management and Budget for 

significant rulemaking, this document examines expected economic impacts of the 

interim rule and considers effects for small entities, as required by the Regulatory 

Flexibility Act. The following section presents the expected benefits and costs of the rule

for U.S. producers and consumers, and alternatives to the rule considered by APHIS. In 

the third section, we discuss the expected effects on small entities. We conclude with a 

summary statement on the expected benefits and costs of the rule, including effects on 

small entities.

EXPECTED BENEFITS AND COSTS OF THE RULE

Because of the current substantial overlap between existing restrictions to prevent 

the importation of articles that could introduce END and the new restrictions to prevent 

the importation of articles that could spread HPAI, this rule is not expected to cause 

significant economic effects. The effects it does have benefit domestic poultry producers 

and the associated costs should be borne largely by importers of poultry and poultry 

products.

United States’ poultry production. The poultry industry has become increasingly 

vertically integrated over the last four decades, with broiler production dependent on

contracting arrangements rather than the traditional livestock production system. In 

addition to supply chain integration, NAFTA has led to a somewhat more economically 

integrated market in North America than existed previously, particularly for the United 

States and Mexico due to an easing of Mexican trade restrictions that has allowed the 

United States to expand exports (Hahn, et al 2005).

Since the 1960s, the poultry and egg industry has undergone substantial structural 

change. Before this time, poultry meat was a residual of the production of eggs. Meat 

tended to come from older fowl and was a seasonal product. The move to consolidation 

in the 1960s and related price declines contributed to an increased demand for chicken. 

Broilers began to be produced strictly for meat rather than meat being a residual product

(ERS 1999).

Before the consolidation of the industry beginning in the 1960s, most farms raised 

chickens and many families kept them as backyard flocks. The focus of this practice was 
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on egg production to meet a family’s needs. Consolidation/integration in the broiler 

industry then accelerated, with feed dealers lending capital to independent producers. 

This eventually progressed into a contract growing arrangement to hedge risk on the part 

of the grower. These changes to the poultry industry have transformed it into a complex 

agribusiness rather than a sideline enterprise (ERS 1999).

Poultry production essentially includes three broad categories: (1) broiler 

production; (2) turkey production; and (3) egg production. Broiler production is 

concentrated in States along the Eastern Seaboard and the Gulf Coast, with most 

production in the top five broiler producing States of Georgia, Arkansas, Alabama, 

Mississippi, and North Carolina. The majority of broiler production occurs under 

contractual arrangements with a processor.

Turkey production is not concentrated in a defined area within the United States. 

The top five States are Minnesota, North Carolina, Missouri, South Carolina, and 

Virginia. The United States is the world’s largest turkey producer, as well as the largest 

per capita consumer of turkey (ERS 2006).

Egg production in the United States serves two sources of demand: the demand 

for table eggs for consumption and the demand for hatching eggs for replacement birds 

for the egg-laying and broiler production firms (ERS 2006). Approximately 75 percent 

of egg production is destined for human consumption with the remaining 25 percent 

going into the hatching market. The top five States in egg production are Iowa, Ohio, 

Pennsylvania, Indiana, and California.

United States’ trade in poultry and poultry products. Historically, the United 

States has been a net exporter of poultry and poultry products (Table 1). The United 

States is one of the top ten exporters of live poultry. Approximately 68 percent of U.S. 

live poultry exports are destined for Canada and Mexico. The remaining exports are 

divided among the Caribbean, Asian, and Central and South American markets. U.S. 

broiler exports are second only to those of Brazil. Russia, China, and Mexico are the 

largest importers of U.S. broiler products, accounting for more than 50 percent of U.S. 

exports (ERS 2006). The United States surpasses all other counties in exports of turkey 

products, with Mexico the largest importer. Egg exports are divided into three 
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Table 1. United States Net Trade (Exports minus Imports) in Poultry and Poultry Products, 2000 - 2005

2000 2001 2002 2003 2004 2005 2006

Live Poultry (1,000 Head)

Chickens 40,035 46,515 43,472 36,197 29,440 33,088 36,750

Turkeys 896 -4,419 -2,294 -236 -1,886 -580 1,124

Ducks, Geese, Guineas 248 1,604 -341 -403 -150 -974 -293

TOTAL 41,179 43,700 40,837 35,558 27,404 31,534 37,581

Meat (Metric Tons)

Chicken

Fresh/Chilled 217,457 150,392 163,093 180,761 248,158 266,717 211,949

Frozen 2,384,281 2,631,261 2,158,437 2,252,481 2,076,171 2,187,468 2,336,901

Turkey

Fresh/Chilled 44,392 48,780 52,727 71,932 80,800 116,736 101,418

Frozen 150,571 151,681 125,657 118,051 92,784 111,914 119,274

Ducks, Geese, Guineas

Fresh/Chilled 27 92 397 366 489 974 1,074

Frozen 3,239 4,123 1,203 1,508 1,417 8,745 4,234

TOTAL 2,799,967 2,986,329 2,501,514 2,625,099 2,499,819 2,692,554 2,774,850

Eggs

In Shell (1,000 Dozen) 89,008 85,448 82,971 80,882 99,621 103,394 102,962

Not In Shell (Metric Tons) 17,418 15,218 15,161 11,417 15,702 20,327 20,588

Poultry Products (Metric Tons)

Feathers and Down -22,149 -22,709 -26,132 -22,170 -20,546 -18,624 -14,715

Skin with Feathers 24,636 39,917 35,004 40,548 39,208 40,383 25,452

TOTAL 2,487 17,208 8,872 18,378 18,662 21,759 10,737

Edible Poultry Meat Preparations 

(Metric Tons)

Animal Livers 1,052 2,299 -280 -247 -21 10,071 251

Prepared/Preserved Chicken Meat 40,928 61,808 36,852 36,304 39,723 57,885 57,145

Meat or Meat Offal of Chickens, 

Turkeys, Ducks, Geese, and Guineas 17,405 36,923 42,396 38,613 30,874 31,286 21,855

TOTAL 59,385 101,030 78,968 74,670 70,576 99,242 79,251

Source: U.S. Department of Commerce Statistics, Census Bureau, U.S. Trade Statistics
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categories: table eggs for consumption, shell eggs for hatching, and egg products (ERS 

2006).3

Imports of poultry and eggs are small in relation to domestic production. Imports 

of broiler products are equal to less than one percent of production (ERS 2006). The 

majority of imports of turkey products come from Canada. However, these imports are 

extremely small at less than 0.02 percent of domestic production. Finally, egg imports 

are only 0.2 percent of domestic production.

 Overall, the United States exports a large amount of eggs and is the second 

largest egg exporter in value terms. Canada and Mexico are the primary importers of 

table eggs, while most shell eggs are destined for Canada and Hong Kong. Egg products, 

which include dried and nondried albumin and dried and nondried yolk, are primarily 

used in the restaurant and baking industries. Major importers of these products are as 

follows: Japan, Spain, and Israel of dried albumin; Canada of nondried albumin; Japan, 

Mexico, and Canada of dried yolk; and Japan, Canada, and South Korea of nondried yolk 

(ERS 2006).

Based on the domestic production and trade volumes, the interim rule is likely to 

benefit producers, while effects on consumers are expected to be negligible. The interim 

rule is intended to regulate imports from countries known to have HPAI of any subtype. 

The rule will benefit producers by protecting domestic flocks against the introduction of 

HPAI. Since imports are miniscule compared to domestic production, consumers are not 

likely to be affected by any changes in imports that may result because of the rule. 

However, the interim rule will help safeguard domestic production, which would be 

negatively affected if HPAI were introduced. The rule will help ensure a steady supply 

of poultry and poultry products on the market, reducing the likelihood of disease-related 

price impacts for consumers.

Costs of complying with the requirements of the rule will largely be borne by 

persons importing poultry and poultry products into the United States. For regions for 

which importers must already comply with restrictions because of END or HPAI subtype 

H5N1, the interim rule will have little or no compliance impacts. Compliance costs will 

be incurred only with respect to imports from affected regions for which there are not 

 3 Although egg exports are divided into three separate categories, Table 1 does not distinguish between 

table eggs for consumption and shell eggs for hatching. Shell eggs are aggregated in this table.
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concurrent END or HPAI subtype H5N1 import restrictions. If in the future APHIS 

restricts poultry or products from a region with HPAI other than subtype H5N1, and that 

region does not already have END or HPAI subtype H5N1, the additional requirements 

would generate new compliance costs. One technical change to the import requirements, 

that cooked poultry carcasses or parts or products of carcasses imported into the United 

States must be cooked to a minimum temperature of 74°C for both HPAI and END, will 

not impose any significant additional costs; the current standard requires that articles 

must “have a thoroughly cooked appearance throughout.”

Alternatives to the rule. Alternatives to the interim rule considered by APHIS 

concerned specific aspects of the rulemaking more so than its overall purpose and 

approach. Two examples are options evaluated by the Agency for notifying changes in

disease status and in deciding the minimum cooking temperature requirement for cooked 

poultry carcasses or parts or products of carcasses imported into the United States.

The Agency determined that maintaining the list of countries known to have cases 

of HPAI on the APHIS website is preferable to maintaining this list in the CFR. Listing 

the regions on the website will facilitate notification of a change in a region’s disease 

status. The rule also provides that APHIS will make a risk assessment available to the 

public prior to removing a region from the list of regions known to have cases of HPAI. 

This will ensure that the public has opportunity to comment on any pending action to 

remove a region. 

Alternatives for codifying the required cooking temperature at which chicken is 

“fully cooked” were also considered by the Agency. APHIS reviewed various cooking 

temperature requirements, including standards required by various countries for human 

food safety purposes and research results that documented the efficacy of various cooking 

temperature/time combinations in destroying infectivity. APHIS determined that the new 

OIE recommended standard for HPAI of a minimum internal temperature of 74 degrees 

Celsius is effective, and when used for both HPAI and END allows for a margin of error 

and better control disease risks. APHIS considered listing separate temperature 

requirements for the two diseases, but decided that requiring a single temperature of 74°C 

will be more practical for many producers, will not pose undue additional costs to 
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producers, and will offer more uniform assurances that either virus is inactivated if 

present.

INITIAL REGULATORY FLEXIBILITY ANALYSIS

The Regulatory Flexibility Act requires that agencies consider the economic 

impact of rule changes on small businesses, organizations, and governmental 

jurisdictions. Section 603 of the Act requires agencies to prepare and make available for 

public comment an initial regulatory flexibility analysis (IRFA) describing the expected 

impact of proposed rules on small entities. Sections 603(b) and 603(c) of the Act specify 

the content of an IRFA. In this section, we address these IRFA requirements for this 

interim rule.

Reasons for Action

APHIS is taking these actions based on the determination that the amendments 

will more closely align APHIS regulations with OIE guidelines. The agency has 

concluded that to prevent the introduction of HPAI into the United States it is necessary 

to impose certain restrictions on birds, poultry, and bird and poultry products imported 

from regions where HPAI is known to exist. Restrictions on the imports of live poultry 

and birds that have been vaccinated for avian influenza or that have moved through 

regions affected by avian influenza will also minimize the potential risks of an 

introduction of avian influenza into the United States. Additionally, APHIS has 

determined that maintaining the list of countries affected by HPAI on the APHIS website 

rather than in the CFR and publishing a Federal Register notice, instead of a proposed 

rule, to announce the availability of a document for public comment showing that a

region has met the conditions for disease-free status will be advantageous due to the 

timeliness of the release of such information to the public. These actions will also 

streamline the regulatory process.

Objectives and Legal Basis for Rule

APHIS is taking these actions to prevent the introduction of HPAI into the United 

States. This rule would amend 9 CFR parts 93, 94, and 95. The legal basis for this rule 
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may be found in the Animal Health Protection Act of 2002, which authorizes the 

Secretary of Agriculture to promulgate regulations to prevent the introduction into the 

United States or dissemination of any pest or disease of livestock.

The objective of the interim rule is to establish requirements that allow the safe 

importation of birds, poultry, and bird and poultry products from countries where HPAI 

of any subtype. Importation of these products will be allowed on the condition that they

follow the import regulations pertaining to countries affected with END with the 

additional stipulation that certain poultry products be cooked to a minimum internal 

temperature of 74°C and be accompanied by a certificate verifying compliance with this 

requirement. The importation of live commercial birds or poultry vaccinated for avian 

influenza, including hatching eggs that were laid by birds or poultry vaccinated for avian 

influenza, and the importation of live birds or poultry, including hatching eggs, that 

transit regions where HPAI of any subtype is known to exist are prohibited. APHIS 

believes these mitigations will prevent the importation of HPAI of any subtype.

An additional objective of the rule is to streamline the regulatory process by 

allowing APHIS to take timely action to close and reopen markets in response to 

detection and eradication of HPAI in foreign regions. This change will benefit APHIS, 

but will have no effect on other federal agencies or state or local governments. It will be 

accomplished by maintaining a list of regions affected by HPAI on the internet.

Description and Estimated Number of Small Entities Regulated

The interim rule may affect domestic poultry producers, as well as firms that 

import poultry and poultry products. The intent of the rule is to safeguard the health of 

domestic poultry flocks and protect producer interests against economic losses that may 

result from an outbreak of HPAI of any subtype. It is likely that the entities affected will

be small according to Small Business Administration (SBA) guidelines. 

Most U.S. poultry and egg producers are small, based on 2002 Census of 

Agriculture data and SBA guidelines for entities in the farm categories Broilers and Other 

Meat Type Chicken Production (NAICS 112320), Turkey Production (NAICS 112330), 

Poultry Hatcheries (NAICS 112340), and Other Poultry Production (NAICS 112390). 

The SBA classifies producers in these categories with total annual sales of not more than 
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$750,000 as small entities. For entities in the farm category Chicken Egg Production 

(NAICS 112310), the SBA classification for small entities is substantially higher, with 

the standard of total annual sales not exceeding $11.5 million. According to the 2002 

Census of Agriculture,4 there were a total of 83,381 farms producing poultry and eggs in 

that year. Of these farms, the percentage breakdown between those producing poultry 

and those producing eggs is not known. However, using the more restrictive SBA 

classification to define a small entity, approximately 83 percent had annual sales in 2002 

of less than $500,000, which is well below the SBA’s threshold of $750,000 for most of 

the listed categories.

5

 It is reasonable to assume that most poultry and egg producers that

may be affected by this rule would qualify as small. If the substantially higher threshold 

of $11.5 million is used, 100 percent of the 83,381 farms would be considered small 

entities based on the 2002 Census data. In the case of live poultry merchant wholesalers 

(NAICS 4244401) and poultry and poultry product (except live) merchant wholesalers 

(NAICS 4244402), establishments with not more than 100 employees are considered 

small by SBA standards. In 2002, there were a total of 37 live poultry wholesale trade 

establishments in the United States.

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The interim rule will help safeguard these predominantly small firms, particularly

producers, from potential HPAI outbreaks and resulting economic losses. Producers will

benefit from the establishment of these requirements. Wholesalers are not likely to be 

greatly impacted by the rule and may benefit from the additional regulatory basis for 

 Of these firms, 35 firms operated for the entire 

year. Of those firms that were in operation the entire year, 35 or 100 percent employed 

fewer than 100 employees and were, therefore, considered small by SBA standards. 

There were a total of 711 poultry and poultry product wholesale trade establishments in 

the United States in 2002. Of these firms, 634 firms operated for the entire year. Of 

those firms that were in operation the entire year, 614 or 96.8 percent employed fewer 

than 100 employees and were, therefore, considered small by SBA standards. Thus, 

domestic producers and importers that may be affected by the rule are predominantly 

small entities.

 4 Available online at http://www.nass.usda.gov/Census_of_Agriculture/index.asp. 5 Source: SBA and 2002 Census of Agriculture. 6 Source: SBA and 2002 Economic Census.
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ensuring that consumers receive disease-free products. APHIS welcomes public 

comment on these potential effects.

APHIS also will streamline the regulatory process for relieving restrictions by 

publishing a notice in the Federal Register announcing the availability of a document for 

public comment showing that a region has met the conditions for disease-free status. In 

addition, APHIS will maintain a list of regions known to have HPAI of any subtype on 

the internet rather than in the CFR, which will provide timely notice for protecting the 

health of U.S. poultry. Entities, large and small, will benefit from the availability of more 

timely information related to the disease status of countries or regions. 

Description and Estimate of Compliance Requirements

Firms wishing to export carcasses and parts or products of carcasses from a region 

where HPAI is considered to exist will be required to obtain a certificate signed by a 

salaried veterinarian of that region’s national government, specifying that the articles 

were cooked to a minimum internal temperature of 74°C prior to shipment to the United 

States. However, the burden of this requirement will be on the foreign firm rather than 

on the domestic import firm. Domestically, this rule does not entail reporting, 

recordkeeping, or other compliance requirements beyond those already required for the 

importation of poultry and poultry products. 

Duplication, Overlap, and Conflict with Existing Rules and Regulations

APHIS has not identified any duplication, overlap, or conflict of the interim rule 

with other Federal rules. 

Significant Alternatives to Rule

It is the position of APHIS that there are no alternatives to the interim rule that 

would satisfactorily accomplish the stated objectives and minimize any significant 

impacts on small entities. We do not expect small entities to be significantly affected by 

the interim rule, other than to benefit from the reduced risk of introduction into the 

United States of HPAI of any subtype.
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SUMMARY

This rule amends the regulations concerning the importation of animals and 

animal products to prohibit or restrict the importation of bird and poultry products from 

regions where any subtype of highly pathogenic avian influenza is considered to exist. 

The rule also adds restrictions concerning importation of live poultry and birds that have 

been vaccinated for avian influenza, or that have moved through regions where any 

subtype of HPAI is considered to exist. These restrictions supplement existing 

restrictions on the importation of live birds and poultry, and bird and poultry products 

and byproducts from regions where exotic Newcastle disease or HPAI are considered to 

exist. They are necessary to prevent the introduction of HPAI into the United States.

Because of the current substantial overlap between existing restrictions to prevent 

the importation of articles that could introduce END and the new restrictions to prevent 

the importation of articles that could spread HPAI, this rule is not expected to cause 

significant economic effects. The effects it does have benefit domestic poultry producers 

and the associated costs should be borne largely by importers of poultry and poultry 

products. 

Based on the domestic production and trade volumes, the interim rule is likely to 

benefit producers by protecting domestic flocks against the introduction of HPAI, while 

effects on consumers are expected to be negligible. The costs of complying with the 

requirements of the rule will largely be borne by persons importing poultry and poultry 

products into the United States. We do not expect small entities to be significantly 

affected by the interim rule, other than to benefit from the reduced risk of introduction 

into the United States of HPAI. Overall, the restrictions placed on imports of birds, 

poultry, and bird and poultry products will closely follow those already in place for END. 

One change will affect certain cooked poultry products, the requirement that cooked 

poultry carcasses or parts or products of carcasses be heated to a minimum internal 

temperature of 74°C before shipment to the United States. The current requirement is 
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cooking that achieves an internal temperature of 70 oC for 5 seconds The change should 

result in negligible additional cost, for several reasons. The primary costs for cooking 

vary with the time and amount of fuel involved. Cooking operations for exported poultry 

products in most countries are not precision operations that barely meet the minimum 

requirement. Rather, they are bulk operations designed to ensure the requirement is met 

with minimal supervision. For this reason, many of these operations routinely use a 

time/temperature system with an ample margin of error, so that batches routinely exceed 

the new requirement. Second, the new requirement is based on an OIE recommendation 

that is already being followed by many countries, independent of the APHIS regulatory 

requirement.
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REFERENCES

Economic Research Service (ERS) of USDA. Broiler Farms’ Organization, 

Management, and Performance. Online publication: 

http://www.ers.usda.gov/publications/aib748/aib748.pdf, March 1999. 

Downloaded May 2006.

ERS. Poultry and Eggs: Background. Online publication: 

http://www.ers.usda.gov/Briefing/Poultry/Background.htm, updated May 3, 2006. 

Downloaded May 2006.

Hahn, William F., Mildred Haley, Dale Leuck, James J. Miller, Janet Perry, Fawzi Taha, 

and Steven Zahniser. Market Integration of the North American Animal Products 

Complex. U.S. Department of Agriculture, Economic Research Service, 

Electronic Outlook Report, LDP-M-131-01, May 2005. Available online at: 

http://www.ers.usda.gov/publications/ldp/may05/ldpm13101/ldpm13101.pdf.