[No title available]

[Federal Register Volume 74, Number 233 (Monday, December 7, 2009)]

[Unknown Section]

[Pages 64149-64181]

From the Federal Register Online via the Government Publishing Office [www.gpo.gov]

[FR Doc No: X09-41207]

[[Page 64149]]

DEPARTMENT OF AGRICULTURE (USDA)

Statement of Regulatory Priorities

USDA's regulatory efforts in 2010 will continue to focus on

implementing the Food, Conservation, and Energy Act of 2008 (Pub. L.

110-246), known as the ``2008 Farm Bill,'' which covers major farm,

trade, conservation, rural development, energy, nutrition assistance

and other programs. In addition, USDA will implement regulations that

will improve program outcomes by achieving the Department's high

priority goals as well as reducing burden on stakeholders, program

participants, and small businesses. Important areas of activity include

the following:

Nutrition Assistance

As changes are made for the nutrition assistance programs,

USDA will work to foster actions that will help improve

diets, and particularly to prevent and reduce overweight

and obesity. In 2010, FNS will continue to promote

nutritional knowledge and education while minimizing

participant and vendor fraud.

Food Safety

In the area of food safety, USDA will continue to develop

science-based regulations that improve the safety of meat,

poultry, egg, and farm-raised catfish products in the least

burdensome and most cost-effective manner. Regulations will

be revised to address emerging food safety challenges,

streamlined to remove excessively prescriptive regulations,

and updated to be made consistent with hazard analysis and

critical control point principles. To assist small entities

to comply with food safety requirements, the Food Safety

and Inspection Service will continue to collaborate with

other USDA agencies and State partners in the enhanced

small business outreach program.

Conservation

USDA will continue to focus on implementing the conservation

programs authorized in the 2008 Farm Bill. Over the past

year, the Natural Resources Conservation Service (NRCS) has

promulgated 11 interim and proposed rules and has received

public comment on them. In 2010, NRCS will finalize these

rules which include the Conservation Stewardship Program

and the Environmental Quality Incentives Program.

Promoting Rural Development and Renewable Energy

USDA priority regulatory actions for the Rural Development

mission primarily relate to promulgating relations for

programs authorized by the 2008 Farm Bill, including the

Title 9 Energy programs and the Rural Micro-

Entrepreneurship Program. USDA has utilized Notices of

Funding Availability implement many of these programs in

Fiscal Year 2009. Regulations are needed to maintain them.

In addition, USDA needs to finalize the reform of its on-

going broadband access program through an interim rule that

will combine provisions of a proposed rule published in

2007 and changes in the program that were authorized in the

2008 Farm Bill.

USDA will continue to promote sustainable economic

opportunities to revitalize rural communities through the

purchase and use of renewable, environmentally friendly

biobased products through its BioPreferred Program

(formerly the Federal Biobased Product Preferred

Procurement Program). USDA will continue to designate

groups of biobased products to receive procurement

preference from Federal agencies and contractors. In

addition, USDA will finalize a rule establishing the

Voluntary Labeling Program for biobased products.

Trade Promotion, Market Development, Farm Loans, and Disaster

Assistance

USDA will work to ensure a strong U.S. agricultural system

through trade promotion, market development, farm income

support, disaster assistance, and farm loan programs. In

addition to the regulations already implemented, including

those pertaining to the eligibility for farm program

payments, the Farm Service Agency will issue new

regulations implementing disaster assistance programs to

compensate agricultural producers for production losses due

to natural disasters. Regulations will also be developed to

implement conservation loan programs intended to help

producers finance the construction of conservation

measures.

Other Regulatory Activities

USDA will work to facilitate a fair, competitive marketplace,

support the organic sector, and continue regulatory work to

protect the health and value of U.S. agricultural and

natural resources. USDA will promulgate regulations to

enhance enforcement of the Packers and Stockyards Act. USDA

will also finalize a rule specifying access to pasture

standards for organically raised ruminants. In addition,

USDA will amend regulations related to the importation of

nursery products and animals and animal products. Further,

USDA will propose specific standards for the humane

handling, care, treatment, and transportation of birds

under the Animal Welfare Act.

Reducing Paperwork Burden on Customers

USDA has made substantial progress in implementing the goal of the

Paperwork Reduction Act of 1995 to reduce the burden of information

collection on the public. To meet the requirements of the Government

Paperwork Elimination Act (GPEA) and the E-Government Act, agencies

across USDA are providing electronic alternatives to their

traditionally paper-based customer transactions. As a result, producers

increasingly have the option to electronically file forms and all other

documentation online. To facilitate the expansion of electronic

government, USDA implemented an electronic authentication capability

that allows customers to ``sign-on'' once and conduct business with all

USDA agencies. Supporting these efforts are ongoing analyses to

identify and eliminate redundant data collections and streamline

collection instructions. The end result of implementing these

initiatives is better service to our customers enabling them to choose

when and where to conduct business with USDA.

Major Regulatory Priorities

This document represents summary information on prospective significant

regulations as called for in Executive Order 12866. The following

agencies are represented in this regulatory plan, along with a summary

of their mission and key regulatory priorities for 2010:

Food and Nutrition Service

Mission: FNS increases food security and reduces hunger in partnership

with cooperating organizations by providing children and low-income

people access to food, a healthful diet, and nutrition education in a

manner that supports American agriculture and inspires public

confidence.

Priorities: In addition to responding to provisions of legislation

authorizing and modifying Federal nutrition assistance programs, FNS's

2010 regulatory plan supports the goal to ensure that all of

[[Page 64150]]

America's children have access to safe, nutritious and balanced meals

and its three related objectives:

Improve Access to Nutritious Food. This objective represents

FNS's efforts to improve nutrition by providing access to

program benefits (food consumed at home, school meals,

commodities) and distributing State administrative funds to

support program operations. To advance this objective, FNS

plans to finalize rules implementing provisions of the Farm

Security and Rural Investment Act of 2002 to simplify

program administration, support work, and improve access to

benefits in the Supplemental Nutrition Assistance Program

(SNAP) formerly the Food Stamp Program. FNS will continue

to improve SNAP administration by developing a rule to

implement provisions of the Food, Conservation, and Energy

Act of 2008 that address eligibility, certification,

employment, and training issues. An interim rule

implementing provisions of the Child Nutrition and WIC

Reauthorization Act of 2004 to establish automatic

eligibility for homeless children for school meals further

supports this objective.

Promote Healthier Eating Habits and Lifestyles. This objective

represents FNS's efforts to improve the diets of its

clients through nutrition education, and to ensure that

program benefits meet appropriate standards to effectively

improve nutrition for program participants. In support of

this objective, FNS plans to propose rules updating the

nutrition standards in the school meals programs; implement

the SNAP nutrition education provisions of the Food,

Conservation, and Energy Act of 2008; and establish

permanent rules for the Fresh Fruit and Vegetable Program

which currently operates in a select number of schools in

each State, the District of Columbia, Guam, Puerto Rico and

the Virgin Islands.

Improve Nutrition Assistance Program Management and Customer

Service. This objective represents FNS's ongoing commitment

to maximize the accuracy of benefits issued, maximize the

efficiency and effectiveness of program operations, and

minimize participant and vendor fraud. In support of this

objective, FNS plans to finalize rules in the Child and

Adult Care Food Program (CACFP) and the Special

Supplemental Nutrition Program for Women, Infants and

Children Program (WIC) to improve program management and

prevent vendor fraud. FNS will also finalize a rule to

improve the SNAP quality control process and propose a rule

to improve the SNAP retailer sanction process.

Food Safety and Inspection Service

Mission: The Food Safety and Inspection Service (FSIS) is responsible

for ensuring that meat, poultry, egg, and catfish products in

interstate and foreign commerce are wholesome, not adulterated, and

properly marked, labeled, and packaged.

Priorities: FSIS is committed to developing and issuing science-based

regulations intended to ensure that meat, poultry, egg, and catfish

products are wholesome and not adulterated or misbranded. FSIS

continues to review its existing authorities and regulations to

streamline excessively prescriptive regulations, to revise or remove

regulations that are inconsistent with the Agency's hazard analysis and

critical control point (HACCP) regulations, and to ensure that it can

address emerging food safety challenges. FSIS is also working with the

Food and Drug Administration (FDA) to better delineate the two

agencies' jurisdictions over various food products. Following are some

of the Agency's recent and planned initiatives:

Non-ambulatory Disabled Cattle. In March 2009, FSIS published a final

rule requiring that all cattle that become non-ambulatory disabled at

any time before slaughter, including those that become non-ambulatory

disabled after passing ante-mortem inspection, must be condemned and

properly disposed of. Under the previous regulations, FSIS inspection

personnel determined, on case by-case basis, the disposition of cattle

that became non-ambulatory disabled after they had passed ante-mortem

inspection. The final rule removed the provision for case-by-case

determination by FSIS inspection personnel.

Country of Origin Labeling. In March 2009, FSIS affirmed its August

2008 interim final rule requiring country-of-origin labeling (COOL) of

any meat or poultry product that is a ``covered commodity'' as defined

by the Agricultural Marketing Service (AMS) in the regulations set out

in AMS's January 2009 final rule on mandatory country-of-origin

labeling (COOL).

2008 Farm Bill-related Rulemakings. The 2008 Farm Bill, made several

amendments to statutes administered by FSIS and gave the Agency other

instructions. As a result, FSIS is developing new regulations to

implement: mandatory inspection for catfish; a program for interstate

shipment of State-inspected meat and poultry products; and recall

procedure and process control reassessment requirements for inspected

establishments.

Catfish Inspection. FSIS is developing regulations to

implement 2008 Farm Bill amendments of the FMIA (in Pub. L.

110-246, Sec. 11016) to make catfish amenable to the FMIA.

The regulations will define ``catfish'' and the scope of

coverage of the regulations to apply to establishments that

process catfish and catfish products. The regulations will

take into account the conditions under which the catfish

are raised and transported to a processing establishment.

Interstate shipment of State-inspected meat and poultry

products. FSIS is proposing regulations to implement a new

voluntary Federal-State cooperative inspection program

under which State-inspected establishments with 25 or fewer

employees would be eligible to ship meat and poultry

products in interstate commerce. State-inspected

establishments selected to participate in this program

would be required to comply with all Federal standards

under the FMIA and the PPIA. These establishments would

receive inspection services from State inspection personnel

that have been trained and certified to assist with

enforcement of the FMIA and PPIA. Meat and poultry products

produced under the program that have been inspected and

passed by selected State inspection personnel would bear a

Federal mark of inspection. Section 11015 of the 2008 Farm

Bill provides for the interstate shipment of State-

inspected meat and poultry products from selected

establishments and requires that FSIS promulgate

implementing regulations no later than 18 months from the

date of its enactment.

Notification, Documentation, and Recordkeeping Requirements

for Inspected Establishments. FSIS is proposing regulations

that will implement Sec. 11017 of the 2008 Farm Bill on

notification, documentation, and recordkeeping requirements

for inspected establishments. This section amends the FMIA

and PPIA to require establishments that are subject to

inspection under these Acts to promptly notify the Agency

when an adulterated or misbranded product received by or

originating from the

[[Page 64151]]

establishment has entered into commerce. Section 11017 also

requires establishments subject to inspection under the

FMIA and PPIA to prepare and maintain current procedures

for the recall of all products produced and shipped by the

establishment and document each reassessment of the

establishment's process control plans.

Revision of Egg Products Inspection Regulations. FSIS is

planning to propose requirements for federally inspected

egg product plants to develop and implement HACCP systems

and sanitation standard operating procedures. The Agency

will be proposing pathogen reduction performance standards

for egg products. Further, the Agency will be proposing to

remove requirements for FSIS approval of egg-product plant

drawings, specifications, and equipment before their use,

and to end the system for pre-marketing approval of

labeling for egg products.

Rulemakings in Support of the FSIS Public Health Information

System. To support its food safety inspection activities,

FSIS is developing the Public Health Information System

(PHIS). PHIS, which is user-friendly and Web-based, will

replace many of the Agency's current systems and automate

many business processes. Among the many other services it

will provide, PHIS will automate and streamline the export

and import application and certification processes. To

facilitate the implementation of these PHIS applications,

FSIS will propose to amend the meat, poultry products, and

egg products inspection regulations to provide for

electronic export and import application and certification

processes as alternatives to the current paper-based

systems for these certifications. The new electronic system

will enable the Agency to process an establishment's

application for export certification, verify that the

establishment and product meet the application and

certification requirements, approve the application, and

process the export certificate. The Agency is proposing the

export application and certification service as a

reimbursable service under Agricultural Marketing Act

authority.

Rulemaking to support control of Escherichia coli O157:H7.

FSIS will propose to require that any business that grinds

or chops raw beef products, including products that are

ground or chopped at the request of an individual consumer,

keep records that will fully and correctly disclose all

transactions involved in the business that are subject to

the FMIA. These records, such as grinding logs, provide

critical information about how, when, and where ground

product was prepared, shipped, received, stored, and

handled, and are essential to illness outbreak

investigations, recalls, and other public health activities

that FSIS conducts. Businesses that will be required to

comply with this proposed rule will be FSIS-inspected

establishments and retail facilities that grind or chop raw

beef products, including beef manufacturing trimmings

derived from cattle not slaughtered on site at the official

establishment or retail store. An FSIS-inspected

establishment that grinds or chops raw beef products

derived from cattle slaughtered at that same establishment

will be exempt from the requirements of the proposed rule.

Other Planned Initiatives:

Performance Standards for Ready-to-Eat Products. FSIS plans to finalize

a February 2001 proposed rule to establish food safety performance

standards for all processed ready-to-eat (RTE) meat and poultry

products and for partially heat-treated meat and poultry products that

are not ready-to-eat. The proposal also contained provisions addressing

post-lethality contamination of RTE products with Listeria

monocytogenes. In June 2003, FSIS published an interim final rule

requiring establishments to prevent L. monocytogenes contamination of

RTE products. The Agency is evaluating the effectiveness of this

interim final rule, which in 2004 was the subject of a regulatory

reform nomination to OMB. FSIS has carefully reviewed its economic

analysis of the interim final rule in response to this recommendation

and is planning to adjust provisions of the rule to reduce the

information collection burden on small businesses. FSIS is also

planning further action with respect to other elements of its 2001

proposal on performance standards for processed meat and poultry

products, based on quantitative risk assessments of target pathogens in

processed products.

FSIS plans to propose to amend the poultry products inspection

regulations to put in place a system in which the establishment sorts

the carcasses for defects, and the Agency verifies that the system is

under control and producing safe and wholesome product. The Agency

would propose to adopt performance standards, designed to ensure that

the establishments are carrying out slaughter, dressing, and chilling

operations in a manner that ensures no significant growth of pathogens.

The chilling performance standard would replace the requirement for

ready-to-cook poultry products to be chilled to 40 [deg]F or below

within certain time limits according to the weight of the dressed

carcasses. Poultry establishments would have to carry out slaughtering,

dressing, and chilling operations in a manner that ensures no

significant growth of pathogens.

FSIS is collaborating with the Food and Drug Administration in an

effort to rationalize the division of food protection responsibilities

between the two agencies and eliminate confusion over which agency has

jurisdiction over which kinds of products. The agencies are taking an

approach that involves considering how the meat or poultry ingredients

contribute to the characteristics and basic identity of food products.

Thus, FSIS plans to propose amending its regulations to exclude from

its jurisdiction cheese and cheese products prepared with less than 50

percent meat or poultry; breads, rolls, and buns prepared with less

than 50 percent meat or poultry; dried poultry soup mixes; flavor bases

and reaction/process flavors; pizza with meat or poultry; and salad

dressings prepared with less than 50 percent meat or poultry. FSIS also

plans to clarify that bagel dogs, natural casings, and closed-face meat

or poultry sandwiches are subject to the Agency's jurisdiction.

FSIS Small Business Implications:

The great majority of businesses regulated by FSIS are small

businesses. Some of the regulations listed above substantially affect

small businesses. Some rulemakings can benefit small businesses. For

example, the rule on interstate shipment of State-inspected products

will open interstate markets to some small State-inspected

establishments that previously could only sell their products within

State boundaries.

FSIS conducts a small business outreach program that provides critical

training, access to food safety experts, and information resources

(such as compliance guidance and questions and answers on various

topics) in forms that are uniform, easily comprehended, and consistent.

The Agency collaborates in this effort with other USDA agencies and

cooperating State partners. For example, FSIS makes plant owners and

[[Page 64152]]

operators aware of loan programs, available through USDA's Rural

Business and Cooperative programs, to help them in upgrading their

facilities. FSIS employees meet proactively with small and very small

plant operators to learn more about their specific needs and provide

joint training sessions for small and very small plants and FSIS

employees.

Agricultural Marketing Service

Mission: The Agricultural Marketing Service (AMS) provides marketing

services to producers, manufacturers, distributors, importers,

exporters, and consumers of food products. The AMS also manages the

government's food purchases, supervises food quality grading, maintains

food quality standards, and supervises the Federal research and

promotion programs.

Priorities: AMS priority items for the next year include a rulemaking

required as a result of passage of the 2008 Farm Bill and a final rule

for the National Organic Program.

Dairy Promotion and Research Program (Dairy Import Assessments). The

Dairy Production Stabilization Act of 1983 (Dairy Act) authorized USDA

to create a national producer program for dairy product promotion,

research, and nutrition education as part of a comprehensive strategy

to increase human consumption of milk and dairy products. Dairy farmers

fund this self-help program through a mandatory assessment on all milk

produced in the contiguous 48 States and marketed commercially. Dairy

farmers administer the national program through the National Dairy

Promotion and Research Board (Dairy Board).

The 2008 Farm Bill extended the program to include producers in Alaska,

Hawaii, and Puerto Rico who will pay an assessment of $0.15 per

hundredweight of milk production. Imported dairy products will be

assessed at $0.075 per hundredweight of fluid milk equivalent. AMS

published proposed regulations establishing the program in the May 19,

2009, Federal Register. The proposal had a 30-day comment period.

Comments received for this rule are currently under review. AMS expects

to publish a final rule early next year.

Access to Pasture. Since implementation of the NOP, some members of the

public have advocated for a more explicit regulatory standard on the

relationship between livestock, particularly dairy animals, and grazing

land. They have asserted the current regulatory language on access to

pasture for ruminants and temporary confinement based on an animal's

stage of production, when applied together, do not provide a uniform

requirement for the pasturing of ruminant animals that meet the

principles underlying an organic management system for livestock and

livestock products that consumers expect. AMS published a proposed rule

with a request for comment on October 24, 2008. The comment period

ended December 23, 2008. AMS received over 80,000 comments. Due to the

high volume of comments received, final action on this rule is not

expected before December 2009.

Animal and Plant Health Inspection Service

Mission: A major part of the mission of the Animal and Plant Health

Inspection Service (APHIS) is to protect the health and value of

American agricultural and natural resources. APHIS conducts programs to

prevent the introduction of exotic pests and diseases into the United

States and conducts surveillance, monitoring, control, and eradication

programs for pests and diseases in this country. These activities

enhance agricultural productivity and competitiveness and contribute to

the national economy and the public health. APHIS also conducts

programs to ensure the humane handling, care, treatment, and

transportation of animals under the Animal Welfare Act.

Priorities: With respect to animal health, APHIS is continuing work to

revise its regulations concerning bovine spongiform encephalopathy

(BSE) to provide a more comprehensive and universally applicable

framework for the importation of certain animals and products. In the

area of plant health, APHIS is in the midst of a revision to its

regulations for importing nursery stock (plants for planting) to better

address plant health risks associated with propagative material. APHIS

also plans to propose standards for the humane handling, care,

treatment, and transportation of birds covered under the Animal Welfare

Act.

Grain, Inspection, Packers and Stockyards Administration

Mission: The Grain Inspection, Packers and Stockyards Administration

facilitates the marketing of livestock, poultry, meat, cereals,

oilseeds, and related agricultural products and promotes fair and

competitive trading practices for the overall benefit of consumers and

American agriculture.

Priorities: GIPSA is continuing work that will finalize its August,

2007 proposed rule regarding the records that live poultry dealers must

furnish poultry growers, including requirements for the timing and

contents of poultry growing arrangements. The requirements contained in

the final rule are intended to help both poultry growers and live

poultry dealers by providing the growers with more information about

the poultry growing arrangement at an earlier stage.

In addition, GIPSA intends to propose a rule that will define practices

or conduct that are unfair, unjustly discriminatory, or deceptive, and/

or that represent the making or giving of an undue or unreasonable

preference or advantage, and ensure that producers and growers can

fully participate in any arbitration process that may arise related to

livestock or poultry contracts. This regulation is being proposed in

accordance with the authority granted to the Secretary by the Packers

and Stockyards Act of 1921 and with the requirements of Sections 11005

and 11006 of the 2008 Farm Bill.

Farm Service Agency

Mission: The Farm Service Agency's (FSA) mission is to stabilize farm

income; to assist owners and operators of farms and ranches to conserve

and enhance soil, water, and related natural resources; to provide

credit to new or existing farmers and ranchers who are temporarily

unable to obtain credit from commercial sources; and to help farm

operations recover from the effects of disaster, as prescribed by

various statutes.

Priorities: FSA's priority for 2009 will be to continue implementing

the 2008 Farm Bill. The 2008 Farm Bill, which was enacted on June 18,

2008, governs Federal farm programs through the 2012. New regulatory

actions include:

Disaster Assistance. The 2008 Farm Bill provides a set of

standing disaster assistance programs, including a new

revenue based program for supplemental agricultural

disaster assistance. These programs require completely new

regulations and revision of existing program regulations.

Biomass Crop Assistance Program. In addition, the 2008 Farm

Bill adds a new biomass crop assistance program that

supports the Administration's energy initiative to

accelerate the investment in and production of biofuels.

The program will provide financial assistance to

agricultural and forest land owners and operators

[[Page 64153]]

to establish and produce eligible crops, including woody

biomass, for conversion to bioenergy, and the collection,

harvest, storage, and transportation of eligible material

for use in a biomass conversion facility.

Farm Loan Programs. The 2008 Farm Bill also requires changes

to farm operating loans, down payment loans, and emergency

loans, including expanding to include socially

disadvantaged farmers, increasing loan limits, loan size,

funding targets, interest rates, and graduating borrowers

to commercial credit. In addition, it establishes a new

direct and guaranteed loan program to assist farmers in

implementing conservation practices. FSA will develop and

issue the regulations and make program funds available to

eligible clientele in as timely a manner as possible.

Natural Resources Conservation Service

Mission: The Natural Resources Conservation Service (NRCS) mission is

to provide leadership in a partnership effort to help America's private

land owners and managers conserve their soil, water, and other natural

resources.

Priorities: NRCS regulatory priorities for FY 2010 will be to finalize

the rules promulgated pursuant to the 2008 Farm Bill. The 2008 Farm

Bill, which was enacted on June 18, 2008, governs USDA conservation

programs through 2012. NRCS promulgated 11 interim and proposed

rulemakings pursuant to the 2008 Farm Bill, and received public comment

for each of the regulations. In order to provide certainty and clarity

for NRCS program participants, NRCS will address the public comments in

final rulemaking and make any necessary clarifications or adjustments

in response to those comments.

Among the programs authorized by the 2008 Farm Bill, the Conservation

Stewardship Program and Environmental Quality Incentives Program

represent a significant public investment in environmental improvement

and stewardship. The 2008 Farm Bill also re-authorized and expanded

several other financial assistance and conservation easement programs,

including the Agricultural Management Assistance program, the Farm and

Ranch Lands Protection Program, the Grasslands Reserve Program, the

Healthy Forests Reserve Program, the Regional Equity provisions, the

State Technical Committee, the Technical Service Provider Assistance

Initiative, the Wetlands Reserve Program, and the Wildlife Habitat

Incentives Program.

During FY 2009, NRCS promulgated an interim final rule to identify

Categorical Exclusions under the National Environmental Policy Act of

1970 to streamline delivery of projects funded by the American Recovery

and Reinvestment Act of 2009. NRCS plans to finalize the Categorical

Exclusion rule in response to public comments. Finally, NRCS intends to

promulgate a program for its ACES program to provide consistency with

how ACES is used by other agencies.

Rural Business-Cooperative Service

Mission: Promoting a dynamic business environment in rural America is

the goal of the Rural Business-Cooperative Service (RBS). Business

Programs works in partnership with the private sector and the

community-based organizations to provide financial assistance and

business planning, and helps fund projects that create or preserve

quality jobs and/or promote a clean rural environment. The financial

resources are often leveraged with those of other public and private

credit source lenders to meet business and credit needs in under-served

areas. Recipients of these programs may include individuals,

corporations, partnerships, cooperatives, public bodies, nonprofit

corporations, Indian tribes, and private companies. The mission of

Cooperative Program of RBS is to promote understanding and use of the

cooperative form of business as a viable organizational option for

marketing and distributing agricultural products.

Priorities: RBS's priority for 2009 will be to fully implement the 2008

Farm Bill. This includes promulgating regulations for Section 9003

(Biorefinery Assistance Program), Section 9004 (Repowering Assistance

Program) Section 9005 (Bioenergy program for Advanced Biofuels) and

Section 6022 (Rural Microentrepreneur Assistance Program). The Agency

has been administering Sections 9003 and 9004 through the use of

various Notices (Notices of Funds Availability and Contract Proposal),

rather than regulation. Revisions to Section 9007 (Rural Energy for

America Program) will be made to incorporate Energy Audits and

Renewable Energy Development Assistance and Feasibility Studies for

Rural Energy Systems as eligible grant purposes, as well as other Farm

Bill changes to the Section 9007 program. In addition, regulations for

the Business and Industry Guaranteed Loan Program will be revised to

reflect Farm Bill provisions relating to locally or regionally produced

agricultural food products. These rules will be developed to minimize

program complexity and burden on the public while enhancing program

delivery and Agency oversight.

Rural Utilities Service

Mission: To improve the quality of life in rural America by providing

investment capital for the deployment of critical rural utilities

telecommunications, electric and water and waste disposal

infrastructure. Financial assistance is provided to rural utilities;

municipalities; commercial corporations; limited liability companies;

public utility districts; Indian tribes; and cooperative, nonprofit,

limited-dividend, or mutual associations. The public-private

partnership which is forged between RUS and these industries results in

billions of dollars in rural infrastructure development and creates

thousands of jobs for the American economy.

Priorities: RUS' priority in 2010 is fulfilling the President's goal of

bringing affordable broadband to all rural Americans by continuing to

develop a final rule for the Broadband Loan Program, which was

authorized by the Farm Security and Rural Investment Act of 2002, P.L.

107-171, (2002 Farm Bill) and subsequently amended by the 2008 Farm

Bill. In May 2007, RUS published a proposed rule to improve the focus

and strengthen the financial stability of the program that was being

administered under regulations developed for the 2002 Farm Bill. Before

this proposed rule could be finalized the 2008 Farm Bill became law,

significantly changing the statutory requirements of the Broadband Loan

Program. Consequently, RUS now plans to publish an interim rule that

will combine the provisions of the proposed rule with the changes made

by the 2008 Farm Bill.

On February 17, 2009, President Obama signed the American Recovery and

Reinvestment Act of 2009 (Recovery Act) into law. The Recovery Act

expanded RUS's existing authority to make loans and provides new

authority to make grants to facilitate broadband deployment in rural

areas. RUS has been tasked with the time sensitive priority of

developing the regulation for this new authority. The Agency will,

however, also continue to develop a final rule for the Broadband

Program based upon change include in the 2008 Farm Bill.

Departmental Administration

Mission: Departmental Administration's mission is to provide management

leadership to ensure that

[[Page 64154]]

USDA administrative programs, policies, advice and counsel meet the

needs of USDA program organizations, consistent with laws and mandates;

and provide safe and efficient facilities and services to customers.

Priorities: In July 2009, USDA's Departmental Administration published

the proposed rule to establish a program to label eligible products

made from biobased feedstocks. As part of this rulemaking, USDA will be

accepting public comments through September 2009 on how to implement a

program that promotes the purchase of products made from agricultural

and forestry feedstocks. Once the public comment period is closed, USDA

will finalize the labeling regulation to allow manufacturers and

vendors of biobased products to display the label on their packaging

and marketing materials. Once completed, this regulation will implement

a section of the 2008 Farm Bill and will promote alternative uses of

agriculture and forest materials.

Aggregate Costs and Benefits

USDA will ensure that its regulations provide benefits that exceed

costs, but are unable to provide an estimate of the aggregated impacts

of its regulations. Problems with aggregation arise due to differing

baselines, data gaps, and inconsistencies in methodology and the type

of regulatory costs and benefits considered. In addition, aggregation

omits benefits and costs that cannot be reliably quantified, such as

improved health resulting from increased access to more nutritious

foods; higher levels of food safety; and increased quality of life

derived from investments in rural infrastructure. Some benefits and

costs associated with rules listed in the Regulatory Plan cannot

currently be quantified as the rules are still being formulated. For

2010, the Department's focus on Farm Bill and other regulations will be

to implement the changes in such a way as to provide benefits while

minimizing program complexity and regulatory burden for program

participants.

_______________________________________________________________________

USDA--Agricultural Marketing Service (AMS)

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FINAL RULE STAGE

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1. NATIONAL ORGANIC PROGRAM: ACCESS TO PASTURE

Priority:

Other Significant

Legal Authority:

7 USC 6501 et seq

CFR Citation:

7 CFR 205

Legal Deadline:

None

Abstract:

The National Organic Program (NOP) is administered by the Agricultural

Marketing Service (AMS). Under the NOP, AMS established national

standards for the production and handling of organically produced

agricultural products. Since implementation of the NOP, some members of

the public have advocated for a more explicit regulatory standard on

the relationship between livestock, particularly dairy animals, and

grazing land. They have asserted the current regulatory language on

access to pasture for ruminants and temporary confinement based on an

animal's stage of production, when applied together, do not provide a

uniform requirement for the pasturing of ruminant animals that meet the

principles underlying an organic management system for livestock and

livestock products that consumers expect. Comments received as a result

of the proposed rule will assist in determining the Agency's next steps

in rulemaking on this issue.

Statement of Need:

AMS has determined that current regulations regarding access to pasture

and the contribution of grazing to the diet of organically raised

livestock lack sufficient specificity and clarity to enable AMS to

efficiently administer the Program. Organic System Plans (OSPs) dealing

with livestock management reflect different application of existing

regulations and interpretations of requirements across Accredited

Certifying Agents (ACAs). AMS has received 11 complaints requesting

enforcement actions for alleged violations of the pasture provisions of

the NOP livestock standards.

Furthermore, over the period 1994 to 2005, the National Organic

Standards Board (NOSB) made six recommendations regarding access to the

outdoors for livestock, pasture, and conditions for temporary

confinement of animals. The NOSB process for the development of

recommendations consists of: (1) identification of a need by members of

the public, the NOSB, or the NOP; (2) development of a draft NOSB

recommendation; (3) public meeting notice published by the NOP on its

website and in the Federal Register; (4) solicitation of public

comments on the recommendation through regulations.gov and at the

NOSB's public meetings; (5) finalization of the recommendation; (6)

NOSB approval of the recommendation; and (7) NOSB referral to the

Secretary for the Secretary's consideration and any appropriate action

(e.g., rulemaking, policy development, guidance).

In response, on April 13, 2006, NOP published an Advanced Notice of

Proposed Rulemaking (ANPRM) (71 FR 19131) seeking input on the role of

pasture in the NOP regulations and what parts of the NOP regulations

should be amended to address the role of pasture in organic livestock

management.

More than 80,500 comments were received on the ANPRM. Support for

strict standards and greater detail on the role of pasture in organic

livestock production was nearly unanimous with just 28 of the comments

opposing changes to the pasture requirements. Organic consumers have

clearly stated in comments that they expect organic ruminants to graze

pasture and receive not less than 30 percent of their Dry Matter Intake

(DMI) needs from grazing. Nearly all of the over 80,500 comments were

received from consumers requesting regulations that would clearly

establish grazing as a primary source of nourishment. Approximately

80,250 of these comments were in a modified form letter. Many of these

consumers requested that grazing account for at least 30 percent of the

ruminant's DMI needs.

AMS published a proposed rule with a request for comment on October 24,

2008. The comment period ended December 23, 2008. AMS received more

than 80,000 comments. Due to the high volume of comments received,

final action on this rule is not expected before December 2009.

Summary of Legal Basis:

The NOP is authorized by the Organic Foods Production Act of 1990

(OFPA), as amended (7 U.S.C. section 6501 et. seq.). The AMS

administers the NOP. Under the NOP, AMS oversees national standards for

the production and handling of organically produced agricultural

products. This action is being taken by AMS to ensure that NOP

livestock production regulations have sufficient specificity and

clarity to enable AMS and accredited certifying agents to efficiently

administer the NOP

[[Page 64155]]

and to facilitate and improve compliance and enforcement. This action

is also intended to satisfy consumer expectations that ruminant

livestock animals graze pastures during the growing season.

Alternatives:

Alternatives to this proposed rulemaking are to: (1) Make no changes to

the existing regulations; (2) adopt a reduced pasturing period, such as

the 120-day minimum period recommended by the NOSB and some commenters;

or (3) adopt a three ruminants per acre stocking rate measure as

suggested by some commenters.

Anticipated Cost and Benefits:

Costs:

This action will increase the cost of production for producers who

currently do not pasture their animals and those producers who do not

manage their pastures at a sufficient level to provide at least 30

percent DMI. For organic slaughter stock producers, an increase in

costs might result in a greater volume of slaughter animals, at least

in the short term, entering the market driving down prices. Longer term

these increased costs could result in increased consumer prices unless

the increased costs are off set by reductions in other costs of

production. Other costs of production that could be expected to go down

are costs associated with producer harvest and purchase of feed and the

cost of herd health.

Benefits:

This final rule brings uniformity in application to the livestock

regulations; especially as they relate to the pasturing of ruminants.

This uniformity will create equitable, consistent, performance

standards for all ruminant livestock producers. Producers who currently

operate based on grazing will perceive a benefit because these

producers claim an economic disadvantage in competing with livestock

operations that do not provide pasture. This proposed rule would also

bring uniformity in application to the livestock regulations. This

uniformity in application will allow the ACAs and AMS to administer the

livestock regulations in a way that reflects consumer preferences

regarding the production of organic livestock and their products.

Commenters have clearly stated that they expect organic ruminants to

graze pasture and receive not less than 30 percent of their dry matter

needs from grazing. Because of this, it is crucial that consumer

expectations are met. This proposed rulemaking is intended to reflect

consumer expectations and producer perspectives. This action makes

clear what access to pasture means under the NOP.

Risks:

None.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

ANPRM 04/13/06 71 FR 19131

ANPRM Comment Period End 06/12/06

NPRM 10/24/08 73 FR 63583

NPRM Comment Period End 12/23/08

Final Action 12/00/09

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Governmental Jurisdictions, Organizations

Government Levels Affected:

Federal, Local, State

Agency Contact:

Richard H. Mathews

Chief of Standards Development and Review Branch

Department of Agriculture

Agricultural Marketing Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-3252

Fax: 202 205-7808

Email: [email protected]

RIN: 0581-AC57

_______________________________________________________________________

USDA--AMS

2. NATIONAL DAIRY PROMOTION AND RESEARCH PROGRAM; FINAL RULE ON

AMENDMENTS TO THE ORDER

Priority:

Other Significant

Legal Authority:

7 USC 4501 to 4514; 7 USC 7401

CFR Citation:

7 CFR 1150

Legal Deadline:

Final, Statutory, September 19, 2008, Assessments on imported dairy

products must be implemented by deadline.

With the passage of Section 1507 in the 2008 Farm Bill, the Dairy Act

was amended to apply certain assessments to Alaska, Hawaii, the

District of Columbia, and the Commonwealth of Puerto Rico. The 2008

Farm Bill authorized the Secretary to issue regulations to implement

the mandatory dairy import assessment without providing a notice and

comment period. However, due to the interest of affected parties a

notice and comment period was provided.

Abstract:

The Dairy Act authorizes the Order for dairy product promotion,

research, and nutrition education as part of a comprehensive strategy

to increase human consumption of milk and dairy products and to reduce

milk surpluses. The program functions to strengthen the dairy

industry's position in the marketplace by maintaining and expanding

domestic and foreign consumption of fluid milk and dairy products.

Amendments to the Order are pursuant to the 2002 and 2008 Farm Bills.

The 2002 Farm Bill mandates that the Order be amended to implement an

assessment on imported dairy products to fund promotion and research.

The 2008 Farm Bill specifies a mandatory assessment rate of 7.5-cent

per hundredweight of milk, or equivalent thereof, on dairy products

imported into the United States. Additionally, in accordance with the

2008 Farm Bill, the term ``United States'' is the Dairy Act is amended

to mean all States, the District of Columbia, and the Commonwealth of

Puerto Rico. Producers in these areas will be assessed 15 cents per

hundredweight for all milk produced and marketed.

Statement of Need:

In response to the May 19, 2009 (74 FR 23359) proposed rule (National

Dairy Promotion and Research Program; Proposed Rule on Amendments to

the Order), AMS received 189 timely comments from consumers, dairy

producers, foreign governments, importers, exporters, manufacturers,

members of Congress, trade associations, and other interested parties.

The comments covered a wide range of topics, including 39 in opposition

to the proposal and 150 in support of the proposal. Opponents of the

proposal expressed concern over the lack of a referendum requirement

among those affected; default assessment rates; lack of ability to no

longer promote State-branded dairy products; lack of importer

organizations eligible to become a Qualified Program; disputed the

cost-benefit analysis for

[[Page 64156]]

importers and producers; and cited unreasonable importer paperwork and

record keeping burdens.

Proponents of the proposal expressed support for an expedited

implementation of the dairy import assessment; cited the enhanced

benefits both domestic producers and importers will receive as a result

of implementation; recommended new Harmonized Tariff Schedule codes;

use of a default assessment rate; recommended regular reporting of the

products and assessments on imports; and all thresholds for compliance

with U.S. trade obligations have been met.

AMS plans to issue a final rule implementing the dairy import

assessment in the near future. In response to the comments received and

after consultation with USTR, AMS is addressing, in the final rule,

referenda, alternative assessment rates, and compliance and enforcement

activity. All remaining changes are miscellaneous and minor in nature

in order to clarify regulatory text.

Summary of Legal Basis:

The National Dairy Promotion and Research Program (National Program) is

authorized under the authorized under the provisions of the Dairy

Production Stabilization Act of 1983 (7 U.S.C. 4501-4514), and the

Dairy Promotion and Research Order (7 CFR Part 1150). The Dairy

Programs unit of USDA's Agricultural Marketing Service has day--to--day

oversight responsibilities for the National Program.

Alternatives:

There are no alternatives, as this rulemaking is a matter of law based

on the 2002 and 2008 Farm Bills.

Anticipated Cost and Benefits:

Assessments to dairy producers under the Order are relatively small

compared to producer revenue. If dairy producers in Alaska, Hawaii, the

District of Columbia, and the Commonwealth of Puerto Rico had paid

assessments of $0.15 per hundredweight of milk marketed in 2007, it is

estimated that $1.1 million would have been paid. This is about 0.6

percent of the $192 million total value of milk produced and marketed

in these areas.

Benefits to producers in these areas are assumed to be similar to those

benefits received by producers of other U.S. geographical regions.

Cornell University has conducted an independent economic analysis of

the Program that is included in the annual report to Congress. Cornell

determined that from 1998 through 2007, each dollar invested in generic

dairy marketing by dairy farmers during the period would return between

$5.52 and $5.94, on average, in net revenue to farmers.

Assessments collected from importers under the National Program will be

relatively small compared to the value of dairy imports. If importers

had been assessed $0.075 per hundredweight, or equivalent thereof, for

imported dairy products in 2007 as specified in this rule, it is

estimated that less than $6.1 million would have been paid. This is

about 0.3 percent of the $2.4 billion value of the dairy products

imported in 2007.

Risks:

If the amendments are not implemented, USDA would be in violation of

the 2002 and 2008 Farm Bills.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 05/19/09 74 FR 23359

NPRM Comment Period End 06/18/09

Final Action 02/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses, Organizations

Government Levels Affected:

None

Agency Contact:

Whitney Rick

Promotion and Research Branch Chief

Department of Agriculture

Agricultural Marketing Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-6909

Fax: 202 720-0285

Email: [email protected]

RIN: 0581-AC87

_______________________________________________________________________

USDA--Animal and Plant Health Inspection Service (APHIS)

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PROPOSED RULE STAGE

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3. ANIMAL WELFARE; REGULATIONS AND STANDARDS FOR BIRDS

Priority:

Other Significant

Legal Authority:

7 USC 2131 to 2159

CFR Citation:

9 CFR 1 to 3

Legal Deadline:

None

Abstract:

APHIS intends to establish standards for the humane handling, care,

treatment, and transportation of birds other than birds bred for use in

research.

Statement of Need:

The Farm Security and Rural Investment Act of 2002 amended the

definition of animal in the Animal Welfare Act (AWA) by specifically

excluding birds, rats of the genus Rattus, and mice of the genus Mus,

bred for use in research. While the definition of animal in the

regulations contained in 9 CFR part 1 has excluded rats of the genus

Rattus and mice of the genus Mus bred for use in research, that

definition has also excluded all birds (i.e., not just those birds bred

for use in research). In line with this change to the definition of

animal in the AWA, APHIS intends to establish standards in 9 CFR part 3

for the humane handling, care, treatment, and transportation of birds

other than those birds bred for use in research.

Summary of Legal Basis:

The Animal Welfare Act (AWA) authorizes the Secretary of Agriculture to

promulgate standards and other requirements governing the humane

handling, care, treatment, and transportation of certain animals by

dealers, research facilities, exhibitors, operators of auction sales,

and carriers and immediate handlers. Animals covered by the AWA include

birds that are not bred for use in research.

Alternatives:

To be identified.

Anticipated Cost and Benefits:

To be determined.

Risks:

Not applicable.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 01/00/10

NPRM Comment Period End 04/00/10

Regulatory Flexibility Analysis Required:

Yes

[[Page 64157]]

Small Entities Affected:

Businesses

Government Levels Affected:

Undetermined

Additional Information:

Additional information about APHIS and its programs is available on the

Internet at http://www.aphis.usda.gov.

Agency Contact:

Gerald Rushin

Veterinary Medical Officer, Animal Care

Department of Agriculture

Animal and Plant Health Inspection Service

4700 River Road, Unit 84

Riverdale, MD 20737-1234

Phone: 301 734-0954

RIN: 0579-AC02

_______________________________________________________________________

USDA--APHIS

4. BOVINE SPONGIFORM ENCEPHALOPATHY; IMPORTATION OF BOVINES AND BOVINE

PRODUCTS

Priority:

Other Significant

Legal Authority:

7 USC 450; 7 USC 1622; 7 USC 7701 to 7772; 7 USC 8301 to 8317; 21 USC

136 and 136a; 31 USC 9701

CFR Citation:

9 CFR 92 to 96; 9 CFR 98

Legal Deadline:

None

Abstract:

This rulemaking would amend the regulations regarding the importation

of bovines and bovine products. Under this rulemaking, countries would

be classified as either negligible risk, controlled risk, or

undetermined risk for bovine spongiform encephalopathy (BSE). Some

commodities would be allowed importation into the United States

regardless of the BSE classification of the country of export. Other

commodities would be subject to importation restrictions or

prohibitions based on the type of commodity and the BSE classification

of the country. The criteria for country classification and commodity

import would be closely aligned with those of the World Organization

for Animal Health.

Statement of Need:

We are proposing to amend the regulations after conducting a thorough

review of relevant scientific literature and a comprehensive evaluation

of the issues and concluding that the proposed changes would continue

to guard against the introduction of BSE into the United States, while

allowing the importation of additional animals and animal products into

this country.

Summary of Legal Basis:

Under the Animal Health Protection Act of 2002 (7 U.S.C. 8301 et seq.),

the Secretary of Agriculture is authorized to promulgate regulations to

prevent the introduction into the United States or dissemination of any

pest or disease of livestock.

Alternatives:

We could leave the current bovine regulations unchanged, but

maintaining the status quo would not provide an opportunity to apply

the latest scientific evidence to our BSE-related import conditions.

Another alternative--modifying the BSE regulations related to the

importation of bovines and bovine-derived products to precisely match

the OIE guidelines without allowing for modification deemed necessary

by APHIS--would not allow APHIS to independently interpret the

scientific literature or reflect current USDA regulations and policies.

Making no changes to the current regulations that govern the

importation of cervids and camelids would perpetuate an unnecessary

constraint on trade in those commodities, because cervids and camelids

pose an extremely low BSE risk.

Anticipated Cost and Benefits:

Undetermined.

Risks:

APHIS has concluded that the proposed changes would continue to guard

against the introduction of BSE into the United States.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 12/00/09

NPRM Comment Period End 02/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Federal

International Impacts:

This regulatory action will be likely to have international trade and

investment effects, or otherwise be of international interest.

Additional Information:

Additional information about APHIS and its programs is available on the

Internet at http://www.aphis.usda.gov.

Agency Contact:

Christopher Robinson

Senior Staff Veterinarian, Technical Trade Services, National Center

for Import and Export, VS

Department of Agriculture

Animal and Plant Health Inspection Service

4700 River Road, Unit 40

Riverdale, MD 20737-1231

Phone: 301 734-7837

RIN: 0579-AC68

_______________________________________________________________________

USDA--APHIS

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FINAL RULE STAGE

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5. IMPORTATION OF PLANTS FOR PLANTING; ESTABLISHING A NEW CATEGORY OF

PLANTS FOR PLANTING NOT AUTHORIZED FOR IMPORTATION PENDING RISK

ASSESSMENT (RULEMAKING RESULTING FROM A SECTION 610 REVIEW)

Priority:

Other Significant

Legal Authority:

7 USC 450; 7 USC 7701 to 7772; 7 USC 7781 to 7786; 21 USC 136 and 136a

CFR Citation:

7 CFR 319

Legal Deadline:

None

Abstract:

This action would establish a new category in the regulations governing

the importation of nursery stock, also known as plants for planting.

This category would list taxa of plants for planting whose importation

is not authorized pending risk assessment. We would allow foreign

governments to request that a pest risk assessment be conducted for a

taxon whose importation is not authorized pending risk evaluation.

After the pest risk assessment was completed, we would conduct

rulemaking to remove the

[[Page 64158]]

taxon from the proposed category if determined appropriate by the risk

assessment. We are also proposing to expand the scope of the plants

regulated in the plants for planting regulations to include non-

vascular plants. These changes would allow us to react more quickly to

evidence that a taxon of plants for planting may pose a pest risk while

ensuring that our actions are based on scientific evidence.

Statement of Need:

APHIS typically relies on inspection at a Federal plant inspection

station or port of entry to mitigate the risks of pest introduction

associated with the importation of plants for planting. Importation of

plants for planting is further restricted or prohibited only if there

is specific evidence that such importation could introduce a quarantine

pest into the United States. Most of the taxa of plants for planting

currently being imported have not been thoroughly studied to determine

whether their importation presents a risk of introducing a quarantine

pest into the United States. The volume and the number of types of

plants for planting have increased dramatically in recent years, and

there are several problems associated with gathering data on what

plants for planting are being imported and on the risks such

importation presents. In addition, quarantine pests that enter the

United States via the importation of plants for planting pose a

particularly high risk of becoming established within the United

States. The current regulations need to be amended to better address

these risks.

Summary of Legal Basis:

The Secretary of Agriculture may prohibit or restrict the importation

or entry of any plant if the Secretary determines that the prohibition

or restriction is necessary to prevent the introduction into the United

States of a plant pest or noxious weed (7 U.S.C. 7712).

Alternatives:

APHIS has identified one alternative to the approach we are

considering. We could prohibit the importation of all nursery stock

pending risk evaluation, approval, and notice-and-comment rulemaking,

similar to APHIS's approach to regulating imported fruits and

vegetables. This approach would lead to a major interruption in

international trade and would have significant economic effects on both

U.S. importers and U.S. consumers of plants for planting.

Anticipated Cost and Benefits:

Undetermined.

Risks:

In the absence of some action to revise the nursery stock regulations

to allow us to better address pest risks, increased introductions of

plant pests via imported nursery stock are likely, causing extensive

damage to both agricultural and natural plant resources.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 07/23/09 74 FR 36403

NPRM Comment Period End 10/21/09

Final Rule 07/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and

investment effects, or otherwise be of international interest.

Additional Information:

Additional information about APHIS and its programs is available on the

Internet at http://www.aphis.usda.gov.

Agency Contact:

Arnold T. Tschanz

Senior Risk Manager, Commodity Import Analysis and Operations, PPQ

Department of Agriculture

Animal and Plant Health Inspection Service

4700 River Road, Unit 133

Riverdale, MD 20737-1231

Phone: 301 734-5306

RIN: 0579-AC03

_______________________________________________________________________

USDA--Grain Inspection, Packers and Stockyards Administration (GIPSA)

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PROPOSED RULE STAGE

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6. ENFORCEMENT OF THE PACKERS AND STOCKYARDS ACT

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority:

7 USC 181

CFR Citation:

9 CFR 201

Legal Deadline:

Final, Statutory, June 18, 2010.

Abstract:

GIPSA is proposing regulations under the Packers & Stockyards Act,

1921, that clarify when certain conduct in the livestock and poultry

industries represents the making or giving of an undue or unreasonable

preference or advantage or subjects a person or locality to an undue or

unreasonable prejudice or disadvantage. These proposed regulations also

establish criteria GIPSA will consider in determining whether a live

poultry dealer has provided reasonable notice to poultry growers of any

suspension of the delivery of birds under a poultry growing

arrangement; when a requirement of additional capital investments over

the life of a poultry growing arrangement or swine production contract

constitutes a violation of the P&S Act; and whether a live poultry

dealer or swine contractor has provided a reasonable period of time for

a poultry grower or a swine production contract grower to remedy a

breach of contract that could lead to termination of the poultry

growing arrangement or swine production contract. The Farm Bill also

instructed the Secretary to promulgate regulations to ensure that

producers and growers are afforded the opportunity to fully participate

in the arbitration process if they so choose.

Statement of Need:

In enacting Title XI of the Food, Conservation and Energy Act of 2008

(Farm Bill) (P.L. 110-246), Congress recognized the nature of problems

encountered in the livestock and poultry industries and amended the

Packers and Stockyards Act (P&S Act). These amendments established new

requirements for participants in the livestock and poultry industries

and required the Secretary of Agriculture (Secretary) to establish

criteria to consider when determining that certain other conduct is in

violation of the P&S Act.

The Grain Inspection, Packers and Stockyards Administration's (GIPSA)

attempts to enforce the broad prohibitions of the P&S Act have been

frustrated, in part because it has not previously defined what conduct

[[Page 64159]]

constitutes an unfair practice or the giving of an undue preference or

advantage. The new regulations that GIPSA is proposing describe and

clarify conduct that violates the P&S Act and allow for more effective

and efficient enforcement by GIPSA. They will clarify conditions for

industry compliance with the P&S Act and provide for a fairer market

place.

In accordance with the Farm Bill, GIPSA is proposing regulations under

the P&S Act that would clarify when certain conduct in the livestock

and poultry industries represents the making or giving of an undue or

unreasonable preference or advantage or subjects a person or locality

to an undue or unreasonable prejudice or disadvantage. These proposed

regulations also establish criteria that GIPSA will consider in

determining whether a live poultry dealer has provided reasonable

notice to poultry growers of a suspension of the delivery of birds

under a poultry growing arrangement; when a requirement of additional

capital investments over the life of a poultry growing arrangement or

swine production contract constitutes a violation of the P&S Act; and

whether a packer, swine contractor or live poultry dealer has provided

a reasonable period of time for a grower or a swine producer to remedy

a breach of contract that could lead to termination of the growing

arrangement or production contract.

The Farm Bill also instructed the Secretary to promulgate regulations

to ensure that poultry growers, swine production contract growers and

livestock producers are afforded the opportunity to fully participate

in the arbitration process, if they so choose. We are proposing a

required format for providing poultry growers, swine production

contract growers and livestock producers the opportunity to decline the

use of arbitration in contracts requiring arbitration. We are also

proposing criteria that we will consider in finding that poultry

growers, swine production contract growers and livestock producers have

a meaningful opportunity to participate fully in the arbitration

process if they voluntarily agree to do so. We will use these criteria

to assess the overall fairness of the arbitration process.

In addition to proposing regulations in accordance with the Farm Bill,

GIPSA is proposing regulations that would prohibit certain conduct

because it is unfair, unjustly discriminatory or deceptive, in

violation of the P&S Act. These additional proposed regulations are

promulgated under the authority of Sec. 407 of the P&S Act, and

complement those required by the Farm Bill to help ensure fair trade

and competition in the livestock and poultry industries.

These regulations are intended to address the increased use of

contracting in the marketing and production of livestock and poultry by

entities under the jurisdiction of the P&S Act, and practices that

result from the use of market power and alterations in private property

rights, which violate the spirit and letter of the P&S Act. The effect

increased contracting has had, and continues to have, on individual

agricultural producers has significantly changed the industry and the

rural economy as a whole, making these proposed regulations necessary.

Summary of Legal Basis:

Section 407 of the P&S Act (7 U.S.C. 228) provides that the Secretary

``may make such rules, regulations, and orders as may be necessary to

carry out the provisions of this Act.'' Sections 11005 and 11006 of the

Farm Bill became effective June 18, 2008, and instruct the Secretary to

promulgate additional regulations as described in this notice of

proposed rulemaking.

Alternatives:

The Farm Bill explicitly directs the Secretary to promulgate certain

regulations. GIPSA determined that additional regulations are necessary

to provide notice to all regulated entities of types of practices and

conduct that GIPSA considers ``unfair'' so that regulated entities are

fully informed of actions or practices that are considered ``unfair''

and therefore, prohibited. Within both the mandatory and discretionary

regulatory provisions we considered alternative options.

For example, GIPSA considered shorter notice periods in situations when

a live poultry dealer suspends delivery of birds to a poultry grower.

These alternatives would not have provided adequate trust and integrity

in the livestock and poultry markets. Other alternatives may have been

more restrictive. We considered prohibiting the use of arbitration to

resolve disputes; however, that option goes against a popular method of

dispute resolution in other industries and is not in line with the

spirit of the 2008 Farm Bill. GIPSA believes that this proposed rule

represents the best option to level the playing field between packers,

swine contractors, live poultry dealers, and the nation's poultry

growers, swine production contract growers, or livestock producers for

the benefit of more efficient marketing and public good.

Anticipated Cost and Benefits:

Costs:

Costs are aggregated into three major types: 1) administrative costs,

which include items such as office work, postage, filing, and copying;

2) costs of analysis, such as a business conducting a profit-loss

analysis; and 3) adjustment costs, such as costs related to changing

business behavior to achieve compliance with the proposed regulation.

Benefits:

Benefits are also aggregated into three major groups: 1) increased

pricing efficiency; 2) allocation efficiency; and 3) competitive

efficiency.

Risks:

None.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 12/00/09

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

None

Agency Contact:

H. Tess Butler

Regulatory Liaison

Department of Agriculture

Grain Inspection, Packers and Stockyards Administration

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-7486

Fax: 202 690-2173

Email: [email protected]

RIN: 0580-AB07

_______________________________________________________________________

USDA--GIPSA

-----------

FINAL RULE STAGE

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7. POULTRY CONTRACTS; INITIATION, PERFORMANCE, AND TERMINATION

Priority:

Other Significant

Legal Authority:

7 USC 221

[[Page 64160]]

CFR Citation:

9 CFR 201

Legal Deadline:

None

Abstract:

GIPSA is amending the regulations issued under the Packers and

Stockyards Act, 1921, regarding the records that live poultry dealers

must furnish poultry growers, including requirements for the timing and

contents of poultry growing arrangements. The amendments to the

regulatlions will require that live poultry dealers timely deliver a

copy of an offered poultry growing arrangement to growers; include

information about any Performance Improvement Plan in poultry growing

arrangements; include provisions for written termination notices in

poultry growing arrangements; and notwithstanding a confidentiality

provision, allow growers to discuss the terms of poultry growing

arrangements with designated individuals.

Statement of Need:

The Grain Inspection Packers and Stockyards Administration (GIPSA)

believes that the failure to disclose certain terms in a poultry

growing arrangement constitutes an unfair, discriminatory, or deceptive

practice in violation of section 202 (7 U.S.C. 192) of the Packers and

Stockyards Act (P&S Act).

Because of vertical integration and high concentration within the

poultry industry, poultry growers do not realistically have the option

of negotiating more favorable poultry growing arrangement terms with

competing live poultry dealers because there may be no other live

poultry dealers in the poultry grower's immediate geographic area or

there may be significant differences in equipment requirements among

live poultry dealers. There is considerable asymmetry of information

and an imbalance in market power. This final rule will level the

playing field by requiring that all live poultry dealers adopt fair and

transparent practices when dealing with poultry growers.

Summary of Legal Basis:

One of GIPSA's primary functions is the enforcement of the P&S Act, (7

U.S.C. 181 et seq.) (P&S Act). Under authority granted to us by the

Secretary of Agriculture, GIPSA is authorized (7 U.S.C. 228) to make

those regulations necessary to carry out the provisions of the P&S Act.

Alternatives:

GIPSA collected input on several alternatives like issuing policy

guidance to GIPSA employees, providing public notice that failure to

provide growers with additional contract information was an unfair

practice in violation of Sec. 202 of the P&S Act, or recommending that

growers seek redress of grievances through civil court action or

arbitration. GIPSA determined that none of these alternatives will meet

the needs of poultry growers. We believe, however, that this final rule

will provide the best means of achieving statutory intent at the lowest

cost to poultry growers and live poultry dealers.

Anticipated Cost and Benefits:

Costs:

The costs to both poultry growers and live poultry dealers are

negligible, as the rule does not impose significant additional

requirements that increase actions that the poultry grower and the live

poultry dealer must enact; they merely affect the timeliness of those

actions. In some cases, the final rule requires that the poultry grower

and the live poultry dealer commit to writing terms and conditions that

are already in effect, but do not mandate what those terms and

conditions must be. Thus, the only additional cost is the cost of

producing and transmitting the printed document.

Benefits:

Collectively, the regulatory provisions in the final rule mitigate

potential asymmetries of information between poultry growers and the

live poultry dealers, which will lead to better decisions on the terms

of compensation and reduce the potential for the expression of anti-

competitive market power. The provisions achieve this primarily by

improving the quality and timeliness of information to growers, and to

some extent to live poultry dealers as well. Benefits should accrue to

poultry growers from an enhanced basis for making the decision as to

whether to enter into a growout contract, and from additional time

available to make plans for any necessary adjustments in those

instances when the poultry grower is subject to a contract termination.

Net social welfare will benefit from improved accuracy in the value

(pricing) decisions involved in transactions between poultry growers

and live poultry dealers as they negotiate contract terms.

Risks:

None.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 08/01/07 72 FR 41952

NPRM Comment Period End 10/30/07

Final Action 12/00/09

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

None

Agency Contact:

H. Tess Butler

Regulatory Liaison

Department of Agriculture

Grain Inspection, Packers and Stockyards Administration

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-7486

Fax: 202 690-2173

Email: [email protected]

RIN: 0580-AA98

_______________________________________________________________________

USDA--Food and Nutrition Service (FNS)

-----------

PROPOSED RULE STAGE

-----------

8. ELIGIBILITY, CERTIFICATION, AND EMPLOYMENT AND TRAINING PROVISIONS

OF THE FOOD, CONSERVATION AND ENERGY ACT OF 2008

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

PL 110-246; PL 104-121

CFR Citation:

7 CFR Part 273

Legal Deadline:

None

Abstract:

This proposed rule would amend the regulations governing the

Supplemental Nutrition Assistance Program (SNAP) to implement

provisions from the Food, Conservation and Energy Act of 2008 (Public

Law 110-246) (FCEA) concerning the eligibility and

[[Page 64161]]

certification of SNAP applicants and participants and SNAP employment

and training. In addition, this proposed rule would revise the SNAP

regulations throughout 7 CFR Part 273 to change the program name from

the Food Stamp Program to SNAP and to make other nomenclature changes

as mandated by the FCEA. The statutory effective date of these

provisions was October 1, 2008. Food and Nutrition Service (FNS) is

also proposing two discretionary revisions to SNAP regulations to

provide State agencies options that are currently available only

through waivers. These provisions would allow State agencies to average

student work hours and to provide telephone interviews in lieu of face-

to-face interviews. FNS anticipates that this rule would impact the

associated paperwork burdens. (08-006)

Statement of Need:

This proposed rule would amend the regulations governing the

Supplemental Nutrition Assistance Program (SNAP) to implement

provisions from the Food, Conservation and Energy Act of 2008 (Public

Law 110-246) (FCEA) concerning the eligibility and certification of

SNAP applicants and participants and SNAP employment and training. In

addition, this proposed rule would revise the SNAP regulations

throughout 7 CFR Part 273 to change the program name from the Food

Stamp Program to SNAP and to make other nomenclature changes as

mandated by the FCEA. The statutory effective date of these provisions

was October 1, 2008. Food and Nutrition Service (FNS) is also proposing

2 discretionary revisions to SNAP regulations to provide State agencies

options that are currently available only through waivers. These

provisions would allow State agencies to average student work hours and

to provide telephone interviews in lieu of face-to-face interviews. FNS

anticipates that this rule would impact the associated paperwork

burdens.

Summary of Legal Basis:

Food, Conservation, and Energy Act of 2008 (Public Law 110-246) and 7

CFR Part 273.

Alternatives:

Not applicable.

Anticipated Cost and Benefits:

Anticipated costs have not been determined; however, it is anticipated

that this rule would impact the associated paperwork burdens.

Risks:

Not applicable.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 05/00/10

Regulatory Flexibility Analysis Required:

No

Government Levels Affected:

Local, State

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service

10th Floor

3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: [email protected]

RIN: 0584-AD87

_______________________________________________________________________

USDA--FNS

9. SUPPLEMENTAL NUTRITION ASSISTANCE PROGRAM: FARM BILL OF 2008

RETAILER SANCTIONS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority:

PL 110-246

CFR Citation:

7 CFR 276

Legal Deadline:

None

Abstract:

This proposed rule would implement provisions under Section 4132 of the

Food, Conservation and Energy Act of 2008, also referred to as the Farm

Bill of 2008. Under Section 4132, the Department of Agriculture's Food

and Nutrition Service (FNS) is provided with greater authority and

flexibility when sanctioning retail or wholesale food stores that

violate Supplemental Nutrition Assistance Program (SNAP) rules.

Specifically, the Department is authorized to assess a civil penalty

and to disqualify a retail or wholesale food store authorized to

participate in SNAP. Previously, the Department could assess a civil

penalty or disqualification, but not both. Section 4132 also eliminates

the minimum disqualification period which was previously set at six

months.

In addition to implementing statutory provisions, this rule proposes to

provide a clear administrative penalty when an authorized retailer or

wholesale food store redeems a SNAP participant's Program benefits

without the knowledge of the participant. All Program benefits are

issued through the Electronic Benefits Transfer (EBT) system. The EBT

system establishes data that may be used to identify fraud committed by

retail food stores. While stealing Program benefits could be prosecuted

under current statute, Program regulations do not provide a clear

penalty for these thefts. The proposed rule would establish an

administrative penalty for such thefts equivalent to the penalty for

trafficking in Program benefits, which is the permanent

disqualification of a retailer or wholesale food store from SNAP

participation.

Finally, the Department proposes to identify additional administrative

retail violations and the associated sanction that would be imposed

against the retail food store for committing the violation. For

instance, to maintain integrity, FNS requires retail and wholesale food

stores to key enter EBT card data in the presence of the actual EBT

card. The proposed rule would codify this requirement and identify the

specific sanction that would be imposed if retail food stores are found

to be in violation. (08-007)

Statement of Need:

This proposed rule would implement provisions under Section 4132 of the

Food, Conservation and Energy Act of 2008, also referred to as the Farm

Bill of 2008. Under Section 4132, the Department of Agriculture's Food

and Nutrition Service (FNS) is provided with greater authority and

flexibility when sanctioning retail or wholesale food stores that

violate Supplemental Nutrition Assistance Program (SNAP) rules.

Specifically, the Department is authorized to assess a civil penalty

and to disqualify a retail or wholesale food store authorized to

participate in SNAP. Previously, the Department could assess a civil

penalty or disqualification, but not both. Section 4132 also eliminates

the minimum disqualification period which was previously set at six

months. In addition to implementing statutory provisions, this rule

proposes to provide a clear administrative penalty when an authorized

retailer or

[[Page 64162]]

wholesale food store redeems a SNAP participant's Program benefits

without the knowledge of the participant. All Program benefits are

issued through the Electronic Benefits Transfer (EBT) system. The EBT

system establishes data that may be used to identify fraud committed by

retail food stores. While stealing Program benefits could be prosecuted

under current statute, Program regulations do not provide a clear

penalty for these thefts. The proposed rule would establish an

administrative penalty for such thefts equivalent to the penalty for

trafficking in Program benefits, which is the permanent

disqualification of a retailer or wholesale food store from SNAP

participation. Finally, the Department proposes to identify additional

administrative retail violations and the associated sanction that would

be imposed against the retail food store for committing the violation.

For instance, to maintain integrity, FNS requires retail and wholesale

food stores to key enter EBT card data in the presence of the actual

EBT card. The proposed rule would codify this requirement and identify

the specific sanction that would be imposed if retail food stores are

found to be in violation.

Summary of Legal Basis:

Section 4132, Food, Conservation, and Energy Act of 2008 (Public Law

110-246).

Alternatives:

Not applicable.

Anticipated Cost and Benefits:

Anticipated costs are undetermined at this time until more research is

conducted.

Risks:

Not applicable.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 06/00/10

Regulatory Flexibility Analysis Required:

Undetermined

Government Levels Affected:

Undetermined

Federalism:

Undetermined

Additional Information:

Note: This RIN replaces the previously issued RIN 0584-AD78.

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service

10th Floor

3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: [email protected]

RIN: 0584-AD88

_______________________________________________________________________

USDA--FNS

10. FRESH FRUIT AND VEGETABLE PROGRAM

Priority:

Other Significant

Legal Authority:

Food, Conservation, and Energy Act of 2008; National School Lunch Act

(NSLA); 42 U.S.C. 1769(a)

CFR Citation:

7 CFR Part 211

Legal Deadline:

None

Abstract:

The Food, Conservation, and Energy Act of 2008 amended the National

School Lunch Act (NSLA) to add section 19, the Fresh Fruit and

Vegetable Program (FFVP). Section 19 establishes the FFVP as a

permanent national program in a select number of schools in each State,

the District of Columbia, Guam, Puerto Rico, and the Virgin Islands.

Schools in all States must apply annually for FFVP funding.

This proposed rule would implement statutory requirements currently

established through program policy and guidance for operators at the

State and local level. The proposed rule would set forth requirements

detailed in the statute for school selection and participation, State

agency outreach to needy schools, the yearly application process, and

the funding and allocation processes for schools and States. The

proposed rule would also include the statutory per student funding

range and the requirement for a program evaluation.

In addition, the proposed rule would establish oversight activity and

reporting and record keeping requirements that are not included in FFVP

statutory requirements. Implementation of this rule is not expected to

result in expenses for program operators because they receive funding

to cover food purchases and administrative costs. (09-007)

Statement of Need:

The Food, Conservation, and Energy Act of 2008 amended the National

School Lunch Act (NSLA) to add section 19, the Fresh Fruit and

Vegetable Program (FFVP). Section 19 establishes the FFVP as a

permanent national program in a select number of schools in each State,

the District of Columbia, Guam, Puerto Rico, and the Virgin Islands.

Schools in all States must apply annually for FFVP funding. This

proposed rule would implement statutory requirements currently

established through program policy and guidance for operators at the

State and local level. The proposed rule would set forth requirements

detailed in the statute for school selection and participation, State

agency outreach to needy schools, the yearly application process, and

the funding and allocation processes for schools and States. The

proposed rule would also include the statutory per student funding

range and the requirement for a program evaluation.

Summary of Legal Basis:

Section 19, Food, Conservation, and Energy Act of 2008. National School

Lunch Act (NSLA). 42 U.S.C. 1769(a).

Alternatives:

Because this proposed rule would implement statutory requirements set

forth by the Food, Conservation, and Energy Act of 2008 by adding

section 19, the Fresh Fruit and Vegetable Program (FFVP), to the

National School Lunch Act, alternatives to this process are not known

or being pursued at this time.

Anticipated Cost and Benefits:

Implementation of this rule is not expected to result in expenses for

program operators because they receive funding to cover food purchases

and administrative costs.

Risks:

No risks by implementing this proposed rule have been identified at

this time.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 04/00/10

Final Action 12/00/10

Regulatory Flexibility Analysis Required:

No

[[Page 64163]]

Government Levels Affected:

Local, State

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service

10th Floor

3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: [email protected]

RIN: 0584-AD96

_______________________________________________________________________

USDA--FNS

-----------

FINAL RULE STAGE

-----------

11. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM

INTEGRITY

Priority:

Other Significant

Legal Authority:

42 USC 1766; PL 103-448; PL 104-193; PL 105-336

CFR Citation:

7 CFR Part 226

Legal Deadline:

None

Abstract:

This rule amends the Child and Adult Care Food Program (CACFP)

regulations. The changes in this rule result from the findings of State

and Federal program reviews and from audits and investigations

conducted by the Office of Inspector General. This rule revises: State

agency criteria for approving and renewing institution applications;

program training and other operating requirements for child care

institutions and facilities; and State and institution-level monitoring

requirements. This rule also includes changes that are required by the

Healthy Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the

Personal Responsibility and Work Opportunities Reconciliation Act of

1996 (Pub. L. 104-193), and the William F. Goodling Child Nutrition

Reauthorization Act of 1998 (Pub. L. 105-336).

The changes are designed to improve program operations and monitoring

at the State and institution levels and, where possible, to streamline

and simplify program requirements for State agencies and institutions.

(95-024)

Statement of Need:

In recent years, State and Federal program reviews have found numerous

cases of mismanagement, abuse, and in some instances, fraud, by child

care institutions and facilities in the CACFP. These reviews revealed

weaknesses in management controls over program operations and examples

of regulatory noncompliance by institutions, including failure to pay

facilities or failure to pay them in a timely manner; improper use of

program funds for non-program expenditures; and improper meal

reimbursements due to incorrect meal counts or to mis-categorized or

incomplete income eligibility statements. In addition, audits and

investigations conducted by the Office of Inspector General (OIG) have

raised serious concerns regarding the adequacy of financial and

administrative controls in CACFP. Based on its findings, OIG

recommended changes to CACFP review requirements and management

controls.

Summary of Legal Basis:

Some of the changes proposed in the rule are discretionary changes

being made in response to deficiencies found in program reviews and OIG

audits. Other changes codify statutory changes made by the Healthy

Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal

Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub.

L. 104-193), and the William F. Goodling Child Nutrition

Reauthorization Act of 1998 (Pub. L. 105-336).

Alternatives:

In developing the proposal, the Agency considered various alternatives

to minimize burden on State agencies and institutions while ensuring

effective program operation. Key areas in which alternatives were

considered include State agency reviews of institutions and sponsoring

organization oversight of day care homes.

Anticipated Cost and Benefits:

This rule contains changes designed to improve management and financial

integrity in the CACFP. When implemented, these changes would affect

all entities in CACFP, from USDA to participating children and

children's households. These changes will primarily affect the

procedures used by State agencies in reviewing applications submitted

by, and monitoring the performance of, institutions which are

participating or wish to participate in the CACFP. Those changes which

would affect institutions and facilities will not, in the aggregate,

have a significant economic impact.

Data on CACFP integrity is limited, despite numerous OIG reports on

individual institutions and facilities that have been deficient in

CACFP management. While program reviews and OIG reports clearly

illustrate that there are weaknesses in parts of the program

regulations and that there have been weaknesses in oversight, neither

program reviews, OIG reports, nor any other data sources illustrate the

prevalence and magnitude of CACFP fraud and abuse. This lack of

information precludes USDA from estimating the amount of money lost due

to fraud and abuse or the reduction in fraud and abuse the changes in

this rule will realize.

Risks:

Operating under interim rules puts State agencies and institutions at

risk of implementing Program provisions subject to change in a final

rule.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 09/12/00 65 FR 55103

NPRM Comment Period End 12/11/00

Interim Final Rule 06/27/02 67 FR 43448

Interim Final Rule

Effective 07/29/02

Interim Final Rule

Comment Period End 12/24/02

Interim Final Rule 09/01/04 69 FR 53502

Interim Final Rule

Effective 10/01/04

Interim Final Rule

Comment Period End 09/01/05

Final Action 03/00/10

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

Local, State

Federalism:

This action may have federalism implications as defined in EO 13132.

[[Page 64164]]

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service

10th Floor

3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: [email protected]

Related RIN: Merged with 0584-AC94

RIN: 0584-AC24

_______________________________________________________________________

USDA--FNS

12. SNAP: ELIGIBILITY AND CERTIFICATION PROVISIONS OF THE FARM SECURITY

AND RURAL INVESTMENT ACT OF 2002

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

PL 107-171, sections 4101 to 4109, 4114, 4115, and 4401

CFR Citation:

7 CFR Part 273

Legal Deadline:

None

Abstract:

This rulemaking will amend the regulations of the Supplemental

Nutrition Assistance Program (SNAP), formerly known as the Food Stamp

Program, to implement 11 provisions of the Farm Security and Rural

Investment Act of 2002 that establish new eligibility and certification

requirements for the receipt of food stamps. (02-007)

Statement of Need:

The rule is needed to implement the food stamp certification and

eligibility provisions of Public Law 107-171, the Farm Security and

Rural Investment Act of 2002.

Summary of Legal Basis:

The legal basis for this rule is Public Law 107-171, the Farm Security

and Rural Investment Act of 2002.

Alternatives:

This final rule deals with changes required by Public Law 107-171, the

Farm Security and Rural Investment Act of 2002. The Department has

limited discretion in implementing provisions of that law. Most of the

provisions in this rule were effective October 1, 2002, and were

implemented by State agencies prior to publication of this rule.

Anticipated Cost and Benefits:

The provisions of this rule simplify State administration of SNAP,

increase eligibility for the program among certain groups, increase

access to the program among low-income families and individuals, and

increase benefit levels. The provisions of Public Law 107-171

implemented by this rule have a 5-year cost of approximately $1.9

billion.

Risks:

SNAP provides nutrition assistance to millions of Americans

nationwide--working families, eligible non-citizens, and elderly and

disabled individuals. Many low-income families don't earn enough money

and many elderly and disabled individuals don't receive enough in

retirement or disability benefits to meet all of their expenses and

purchase healthy and nutritious meals. SNAP serves a vital role in

helping these families and individuals achieve and maintain self-

sufficiency and purchase a nutritious diet. This rule implements the

certification and eligibility provisions of Public Law 107-171, the

Farm Security and Rural Investment Act of 2002. It simplifies State

administration of SNAP, increases eligibility for the program among

certain groups, increases access to the program among low-income

families and individuals, and increases benefit levels. The provisions

of this rule increase benefits by approximately $1.95 billion over 5

years.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 04/16/04 69 FR 20724

NPRM Comment Period End 06/15/04

Final Action 12/00/09

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

Local, State

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service

10th Floor

3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: [email protected]

RIN: 0584-AD30

_______________________________________________________________________

USDA--FNS

13. QUALITY CONTROL PROVISIONS

Priority:

Other Significant

Legal Authority:

7 USC 2011 to 2032; PL 107-171

CFR Citation:

7 CFR 273; 7 CFR 275

Legal Deadline:

None

Abstract:

This rule finalizes the interim rule ``Non-Discretionary Quality

Control Provisions of Title IV of Public Law 107-171'' (published

October 16, 2003 at 68 FR 59519) and the proposed rule ``Discretionary

Quality Control Provisions of Title IV of Public Law 107-171''

(published September 23, 2005 at 70 FR 55776).

The following quality control (QC) provisions required by sections 4118

and 4119 of the Farm Security and Rural Investment Act of 2002 (title

IV of Pub. L. 107-171) and contained in the interim rule are

implemented by this final rule:

1) Timeframes for completing quality control reviews;

2) Timeframes for completing the arbitration process;

3) Timeframes for determining final error rates;

4) The threshold for potential sanctions and time period for sanctions;

5) The calculation of State error rates;

6) The formula for determining States' liability amounts;

7) Sanction notification and method of payment; and

8) Corrective action plans.

The following provisions required by sections 4118 and 4119 and

additional policy and technical changes, and contained in the proposed

rule, are implemented by this final rule.

[[Page 64165]]

Legislative changes based on or required by sections 4118 and 4119:

1) Eliminate enhanced funding;

2) Establish timeframes for completing individual quality control

reviews; and

3) Establish procedures for adjusting liability determinations

following appeal decisions.

Policy and technical changes:

1) Require State agency QC reviewers to attempt to complete review when

a household refuses to cooperate;

2) Mandate FNS validation of negative sample for purposes of high

performance bonuses;

3) Revise procedures for conducting negative case reviews;

4) Revise timeframes for household penalties for refusal to cooperate

with State and Federal QC reviews;

5) Revise procedures for QC reviews of demonstration and SSA processed

cases;

6) Eliminate requirement to report differences resulting from Federal

information exchange systems (FIX) errors;

7) Eliminate references to integrated QC; and

8) Update definitions section to remove out-dated definitions. (02-014)

Statement of Need:

The rule is needed to implement the food stamp quality control

provisions of Public Law 107-171, the Farm Security and Rural

Investment Act of 2002.

Summary of Legal Basis:

The legal basis for this rule is Public Law 107-171, the Farm Security

and Rural Investment Act of 2002.

Alternatives:

This rule deals with changes required by Public Law 107-171, the Farm

Security and Rural Investment Act of 2002. The Department has no

discretion in implementing the time frames for completing quality

control reviews, the arbitration process, and determining the final

error rates; the threshold for potential sanctions and the time period

for the sanctions; the calculation for State error rates; the formula

for determining liability amounts; the sanction notification; method of

payment for liabilities; corrective action planning, and the

elimination of enhanced funding. These provisions were effective for

the fiscal year 2003 quality control review period and must have been

implemented by FNS and State agencies during fiscal year 2003. This

rule also deals in part with discretionary changes to the quality

control system resulting from Public Law 107-171. The provision

addressing results of appeals is required to be regulated by Public Law

107-171. The remaining changes amend existing regulations and are

required to make technical changes resulting from these changes or to

update policy consistent with current requirements.

Anticipated Cost and Benefits:

The provisions of this rule are not anticipated to have any impact on

benefit levels or administrative costs.

Risks:

The FSP provides nutrition assistance to millions of Americans

nationwide. The quality control system measures the accuracy of States

providing food stamp benefits to the program recipients. This rule is

intended to implement the quality control provisions of Public Law 107-

701, the Farm Security and Rural Investment Act of 2002. It will

significantly revise the system for determining State agency

liabilities and sanctions for high payment error rates.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

Interim Final Rule 10/16/03 68 FR 59519

Interim Final Rule

Effective 12/15/03

Interim Final Rule

Comment Period End 01/14/04

NPRM 09/23/05 70 FR 55776

NPRM Comment Period End 12/22/05

Final Action 03/00/10

Regulatory Flexibility Analysis Required:

No

Government Levels Affected:

Federal, Local, State

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service

10th Floor

3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: [email protected]

Related RIN: Merged with 0584-AD37

RIN: 0584-AD31

_______________________________________________________________________

USDA--FNS

14. DIRECT CERTIFICATION OF CHILDREN IN FOOD STAMP HOUSEHOLDS AND

CERTIFICATION OF HOMELESS, MIGRANT, AND RUNAWAY CHILDREN FOR FREE MEALS

IN THE NSLP, SBP, AND SMP

Priority:

Other Significant

Legal Authority:

PL 108-265, sec 104

CFR Citation:

7 CFR 210; 7 CFR 215; 7 CFR 220; 7 CFR 245

Legal Deadline:

None

Abstract:

In response to Public Law 108-265, which amended the Richard B. Russell

National School Lunch Act, 7 CFR 245, Determining Eligibility for Free

and Reduced Price Meals and Free Milk in Schools, will be amended to

establish categorical (automatic) eligibility for free meals and free

milk upon documentation that a child is (1) homeless as defined by the

McKinney-Vento Homeless Assistance Act; (2) a runaway served by grant

programs under the Runaway and Homeless Youth Act; or (3) migratory as

defined in section 1309(2) of the Elementary and Secondary Education

Act. The rule also requires phase-in of mandatory direct certification

for children who are members of households receiving food stamps and

continues discretionary direct certification for other categorically

eligible children. (04-018)

Statement of Need:

The changes made to the Richard B. Russell National School Lunch Act

concerning direct certification are intended to improve program access,

reduce paperwork, and improve the accuracy of the delivery of free meal

benefits. This regulation will implement the statutory changes and

provide State agencies and local educational agencies with the policies

and procedures to conduct mandatory and discretionary direct

certification.

Summary of Legal Basis:

These changes are being made in response to provisions in Public Law

108-265.

Alternatives:

FNS will be working closely with State agencies to implement the

changes made by this regulation and will be

[[Page 64166]]

developing extensive guidance materials in conjunction with our

cooperators.

Anticipated Cost and Benefits:

This regulation will reduce paperwork, target benefits more precisely,

and will improve program access of eligible school children.

Risks:

This regulation may require adjustments to existing computer systems to

more readily share information between schools, food stamp offices, and

other agencies.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

Interim Final Rule 02/00/10

Interim Final Rule

Comment Period End 05/00/10

Final Action 05/00/11

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

Local, State

Agency Contact:

James F. Herbert

Regulatory Review Specialist

Department of Agriculture

Food and Nutrition Service

10th Floor

3101 Park Center Drive

Alexandria, VA 22302

Phone: 703 305-2572

Email: [email protected]

Related RIN: Merged with 0584-AD62

RIN: 0584-AD60

_______________________________________________________________________

USDA--Food Safety and Inspection Service (FSIS)

-----------

PROPOSED RULE STAGE

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15. EGG PRODUCTS INSPECTION REGULATIONS

Priority:

Economically Significant. Major under 5 USC 801.

Unfunded Mandates:

Undetermined

Legal Authority:

21 USC 1031 to 1056

CFR Citation:

9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR

590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591; . . .

Legal Deadline:

None

Abstract:

The Food Safety and Inspection Service (FSIS) is proposing to require

egg products plants and establishments that pasteurize shell eggs to

develop and implement Hazard Analysis and Critical Control Points

(HACCP) systems and Sanitation Standard Operating Procedures (SOPs).

FSIS also is proposing pathogen reduction performance standards that

would be applicable to egg products and pasteurized shell eggs. FSIS is

proposing to amend the Federal egg products inspection regulations by

removing current requirements for prior approval by FSIS of egg

products plant drawings, specifications, and equipment prior to their

use in official plants. The Agency also plans to eliminate the prior

label approval system for egg products. This proposal will not

encompass shell egg packers. In the near future, FSIS will initiate

non-regulatory outreach efforts for shell egg packers that will provide

information intended to help them to safely process shell eggs intended

for human consumption or further processing.

Statement of Need:

The actions being proposed are part of FSIS' regulatory reform effort

to improve FSIS' shell egg and egg products food safety regulations,

better define the roles of Government and the regulated industry,

encourage innovations that will improve food safety, remove unnecessary

regulatory burdens on inspected egg products plants, and make the egg

products regulations as consistent as possible with the Agency's meat

and poultry products regulations. FSIS also is taking these actions in

light of changing inspection priorities and recent findings of

Salmonella in pasteurized egg products.

This proposal is directly related to FSIS' PR/HACCP initiative.

Summary of Legal Basis:

This proposed rule is authorized under the Egg Products Inspection Act

(21 U.S.C. 1031 to 1056). It is not the result of any specific mandate

by the Congress or a Federal court.

Alternatives:

A team of FSIS economists and food technologists is conducting a cost-

benefit analysis to evaluate the potential economic impacts of several

alternatives on the public, egg products industry, and FSIS. These

alternatives include: (1) Taking no regulatory action; (2) requiring

all inspected egg products plants to develop, adopt, and implement

written sanitation SOPs and HACCP plans; and (3) converting to a

lethality-based pathogen reduction performance standard many of the

current highly prescriptive egg products processing requirements. The

team will consider the effects of a uniform, across-the-board standard

for all egg products; a performance standard based on the relative risk

of different classes of egg products; and a performance standard based

on the relative risks to public health of different production

processes.

Anticipated Cost and Benefits:

FSIS is analyzing the potential costs of this proposed rulemaking to

industry, FSIS and other Federal agencies, State and local governments,

small entities, and foreign countries. The expected costs to industry

will depend on a number of factors. These costs include the required

lethality, or level of pathogen reduction, and the cost of HACCP plan

and sanitation SOP development, implementation, and associated employee

training. The pathogen reduction costs will depend on the amount of

reduction sought and on the classes of product, product formulations,

or processes.

Relative enforcement costs to FSIS and Food and Drug Administration may

change because the two agencies share responsibility for inspection and

oversight of the egg industry and a common farm-to-table approach for

shell egg and egg products food safety. Other Federal agencies and

local governments are not likely to be affected.

Egg and egg product inspection systems of foreign countries wishing to

export eggs and egg products to the U.S. must be equivalent to the U.S.

system. FSIS will consult with these countries, as needed, if and when

this proposal becomes effective.

This proposal is not likely to have a significant impact on small

entities. The entities that would be directly affected by this proposal

would be the approximately 80 federally inspected egg products plants,

most of which are small businesses, according to Small Business

Administration criteria. If

[[Page 64167]]

necessary, FSIS will develop compliance guides to assist these small

firms in implementing the proposed requirements.

Potential benefits associated with this rulemaking include:

Improvements in human health due to pathogen reduction; improved

utilization of FSIS inspection program resources; and cost savings

resulting from the flexibility of egg products plants in achieving a

lethality-based pathogen reduction performance standard. Once specific

alternatives are identified, economic analysis will identify the

quantitative and qualitative benefits associated with each alternative.

Human health benefits from this rulemaking are likely to be small

because of the low level of (chiefly post-processing) contamination of

pasteurized egg products. In light of recent scientific studies that

raise questions about the efficacy of current regulations, however, it

is likely that measurable reductions will be achieved in the risk of

foodborne illness.

The preliminary anticipated annualized costs of the proposed action are

approximately $7.0 million. The preliminary anticipated benefits of the

proposed action are approximately $90.0 million per year.

Risks:

FSIS believes that this regulatory action may result in a further

reduction in the risks associated with egg products. The development of

a lethality-based pathogen reduction performance standard for egg

products, replacing command-and-control regulations, will remove

unnecessary regulatory obstacles to, and provide incentives for,

innovation to improve the safety of egg products.

To assess the potential risk-reduction impacts of this rulemaking on

the public, an intra-Agency group of scientific and technical experts

is conducting a risk management analysis. The group has been charged

with identifying the lethality requirement sufficient to ensure the

safety of egg products and the alternative methods for implementing the

requirement. FSIS has developed new risk assessments for SE in eggs and

for Salmonella spp. in liquid egg products to evaluate the risk

associated with the regulatory alternatives.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 06/00/10

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

Businesses, Governmental Jurisdictions

Government Levels Affected:

Federal, State

Federalism:

Undetermined

Agency Contact:

Victoria Levine

Program Analyst, Policy Issuances Division

Department of Agriculture

Food Safety and Inspection Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-5627

Fax: 202 690-0486

Email: [email protected]

RIN: 0583-AC58

_______________________________________________________________________

USDA--FSIS

16. PRIOR LABELING APPROVAL SYSTEM: GENERIC LABEL APPROVAL

Priority:

Other Significant

Legal Authority:

21 USC 451 to 470; 21 USC 601 to 695

CFR Citation:

9 CFR 317; 9 CFR 327; 9 CFR 381; 9 CFR 412

Legal Deadline:

None

Abstract:

This rulemaking will continue an effort initiated several years ago by

amending FSIS' regulations to expand the types of labeling that are

generically approved. FSIS plans to propose that the submission of

labeling for approval prior to use be limited to certain types of

labeling, as specified in the regulations. In addition, FSIS plans to

reorganize and amend the regulations by consolidating the nutrition

labeling rules that currently are stated separately for meat and

poultry products (in part 317, subpart B, and part 381, subpart Y,

respectively) and by amending their provisions to set out clearly

various circumstances under which these products are misbranded.

Statement of Need:

Expanding the types of labeling that are generically approved would

permit Agency personnel to focus their resources on evaluating only

those claims or special statements that have health and safety or

economic implications. This would essentially eliminate the time needed

for FSIS personnel to evaluate labeling features and allocate more time

for staff to work on other duties and responsibilities. A major

advantage of this proposal is that it is consistent with FSIS' current

regulatory approach, which separates industry and Agency

responsibilities.

Summary of Legal Basis:

This action is authorized under the Federal Meat Inspection Act (21

U.S.C. 601 et seq.) and the Poultry Products Inspection Act (21 U.S.C.

451 et seq.).

Alternatives:

FSIS considered several options. The first was to expand the types of

labeling that would be generically approved and consolidate into one

part, all of the labeling regulations applicable to products regulated

under the FMIA and PPIA and the policies currently contained in FSIS

Directive 7220.1, Revision 3. The second option FSIS considered was to

consolidate only the meat and poultry regulations that are similar and

to expand the types of generically approved labeling that can be

applied by Federal and certified foreign establishments. The third

option and the one favored by FSIS was to amend the prior labeling

approval system in an incremental three-phase approach.

Anticipated Cost and Benefits:

The proposed rule would permit the Agency to realize an estimated cost

savings of $670,000 over 10 years. The proposed rule would be

beneficial because it would streamline the generic labeling process,

while imposing no additional cost burden on establishments. Consumers

would benefit because industry would have the ability to introduce

products into the marketplace more quickly.

Risks:

None

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 08/00/10

Regulatory Flexibility Analysis Required:

No

[[Page 64168]]

Small Entities Affected:

No

Government Levels Affected:

Undetermined

Agency Contact:

Jeff Canavan

Labeling and Program Delivery Division

Department of Agriculture

Food Safety and Inspection Service

5601 Sunnyside Ave

Beltsville, MD 20705-4576

Phone: 301 504-0878

Fax: 301-504-0872

Email: [email protected]

RIN: 0583-AC59

_______________________________________________________________________

USDA--FSIS

17. CHANGES TO REGULATORY JURISDICTION OVER CERTAIN FOOD PRODUCTS

CONTAINING MEAT AND POULTRY

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority:

21 USC 601(j); 21 USC 454(f)

CFR Citation:

9 CFR 303.1; 9 CFR 381.15

Legal Deadline:

None

Abstract:

The Food Safety and Inspection Service (FSIS) and the Food and Drug

Administration (FDA) have concluded that a clearer approach to

determining jurisdiction over meat and poultry products is possible.

This approach involves considering the contribution of the meat or

poultry ingredients to the identity of the food. FSIS is proposing to

amend the Federal meat and poultry products inspection regulations to

provide consistency and predictability in the regulatory jurisdiction

over nine products or product categories. Historically there has been

confusion about whether these products fall within the jurisdiction of

FSIS or FDA. These proposed changes would exempt cheese and cheese

products prepared with less than 50 percent meat or poultry; breads,

rolls and buns prepared with less than 50 percent meat or poultry;

dried poultry soup mixes; flavor bases and flavors; pizza with meat or

poultry; and salad dressings prepared with less than 50 percent meat or

poultry from the requirements of the Federal Meat Inspection Act and

the Poultry Product Inspection Act and would clarify that bagel dogs,

natural casings, and close faced-sandwiches are subject to the

requirements of the Federal Meat Inspection Act and the Poultry

Products Inspection Act.

Statement of Need:

Over the years, FSIS has made decisions about the jurisdiction under

which food products containing meat or poultry ingredients are produced

based on the amount of meat or poultry in the product; whether the

product is represented as a meat or poultry product (that is, whether a

term that refers to meat or poultry is used on labeling); whether the

product is perceived by consumers as a product of the meat or poultry

industries; and whether the product contains poultry or meat from an

accepted source. With regard to the consumer perception factor, FSIS

made decisions on a case-by-case basis, mostly in response to

situations involving determinations for compliance and enforcement.

Although this case-by-case approach resulted in decisions that made

sense at the time that they were made, a review in 2004 to 2005 by a

working group of FSIS and FDA representatives showed that some of the

decisions do not appear to be fully consistent with other product

decisions and that the reasoning behind various determinations was not

fully articulated or supported.

Summary of Legal Basis:

Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 to 695),

the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 to 470), and

the Egg Products Inspection Act (EPIA) (21 U.S.C. 1032), and the

regulations that implement these Acts, FSIS has authority over all meat

food and poultry products and processed egg products. Under the Federal

Food, Drug, and Cosmetic Act (FFDCA) and the regulations that implement

it, FDA has authority over all foods not under FSIS' jurisdiction,

including dairy, bread and other grain products, vegetables and other

produce, and other products, such as seafood.

According to the provisions of the FMIA and PPIA, the Secretary has the

authority to exempt certain human food products from the definition of

a meat food product (21 U.S.C. 601(j)) or a poultry product (20 U.S.C.

454(f)) based on either of two factors: (1) The product contains only a

relatively small proportion of livestock ingredients or poultry

ingredients, or (2) the product historically has not been considered by

consumers as a product of the meat food or poultry industry, and under

such conditions as he or she may prescribe to ensure that the livestock

or poultry ingredients are not adulterated and that the products are

not represented as meat food or poultry products.

Alternatives:

FSIS has considered over the years a number of variations to clarify

the confusion regarding jurisdiction for these various products.

Alternative 1: Maintain the status quo. Although FSIS has considered

taking no action at this time, the Agency does not recommend this

option because of the continued confusion that exists among industry

and consumers as to jurisdictional coverage for nine categories of

products.

Alternative 2: Reassess the statutory factors for making jurisdiction

decision and recommend an amendment. The amendment of the statute would

be from the historical perception factor because that is the factor, of

the two statutory factors, that the working group identified as leading

to the state of confusion about the jurisdiction of certain products

containing meat or poultry.

Alternative 3: Adopt some of the FDA/FSIS working group's suggested

approach to making clear and transparent jurisdiction decisions by

proposing changes to regulations to codify the current policies on

exempted products.

Anticipated Cost and Benefits:

FSIS estimates that the initial and recurring costs of the rule to

industry would be approximately $5 million and $7 million,

respectively. These costs would be attributable to new Sanitation SOP

and HACCP plan development, as well as to labeling changes and

training. FSIS would incur $7 million in annual recurring costs

(salaries and benefits). Establishments coming under FSIS jurisdiction

also would incur costs for recordkeeping, monitoring, testing, and

annual HACCP plan reassessment.

Benefits to industry would accrue from reduced confusion over Agency

jurisdiction, which may affect labeling and recordkeeping costs. There

may be spill-over benefits accruing from changes in consumer behavior.

Also, there would be improvement in efficiency in use of FDA and FSIS

resources.

[[Page 64169]]

Risks:

None

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 03/00/10

Regulatory Flexibility Analysis Required:

Undetermined

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Charles Gioglio

Labeling and Program Delivery Division

Department of Agriculture

Food Safety and Inspection Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 205-0279

Fax: 202 205-3625

Email: [email protected]

RIN: 0583-AD28

_______________________________________________________________________

USDA--FSIS

18. NEW POULTRY SLAUGHTER INSPECTION

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

21 USC 451 et seq

CFR Citation:

9 CFR 381.66; 9 CFR 381.67; 9 CFR 381.76; 9 CFR 381.83; 9 CFR 381.91; 9

CFR 381.94

Legal Deadline:

None

Abstract:

FSIS is proposing a new inspection system for young poultry slaughter

establishments that would facilitate public health-based inspection.

This new system would be available initially only to young chicken

slaughter establishments. Establishments that slaughter broilers,

fryers, roasters, and Cornish game hens (as defined in 9 CFR 381.170)

would be considered as ``young chicken establishments.'' FSIS is also

proposing to revoke the provisions that allow young chicken slaughter

establishments to operate under the current Streamlined Inspection

System (SIS) or the New Line Speed (NELS) Inspection System. The

proposed rule would establish new performance standards to reduce

pathogens. FSIS anticipates that this proposed rule would provide the

framework for action to provide public health-based inspection in all

establishments that slaughter amenable poultry species.

Under the proposed new system, young chicken slaughter establishments

would be required to sort chicken carcasses and to conduct other

activities to ensure that carcasses are not adulterated before they

enter the chilling tank.

Statement of Need:

Because of the risk to the public health associated with pathogens on

young chicken carcasses, FSIS is proposing a new inspection system that

would allow for more effective inspection of young chicken carcasses,

would allow the Agency to more effectively allocate its resources,

would encourage industry to more readily use new technology, and would

include new performance standards to reduce pathogens.

This proposed rule is an example of regulatory reform because it would

facilitate technological innovation in young chicken slaughter

establishments. It would likely result in more cost-effective dressing

of young chickens that are ready to cook or ready for further

processing. Similarly, it would likely result in more efficient and

effective use of Agency resources.

Summary of Legal Basis:

The Secretary of Agriculture is charged by the Poultry Products

Inspection Act (PPIA--21 U.S.C. 451 et seq.) with carrying out a

mandatory poultry products inspection program. The Act requires post-

mortem inspection of all carcasses of slaughtered poultry subject to

the Act and such reinspection as deemed necessary (21 U.S.C. 455(b)).

The Secretary is authorized to promulgate such rules and regulations as

are necessary to carry out the provisions of the Act (21 U.S.C.

463(b)). The Agency has tentatively determined that this rule would

facilitate FSIS post-mortem inspection of young chicken carcasses. The

proposed new system would likely result in more efficient and effective

use of Agency resources and in industry innovations.

Alternatives:

FSIS considered the following options in developing this proposal:

1) No action.

2) Propose to implement HACCP-Based Inspection Models Pilot in

regulations.

3) Propose to establish a mandatory, rather than a voluntary, new

inspection system for young chicken slaughter establishments.

4) Propose standards of identity regulations for young chickens that

include trim and processing defect criteria and that take into account

the intended use of the product.

5) Propose a voluntary new inspection system for young chicken

slaughter establishments and propose standards of identity for whole

chickens, regardless of the products' intended use.

Anticipated Cost and Benefits:

The proposed performance standards and the implementation of public

health-based inspection would likely improve the public health. FSIS is

conducting a risk assessment for this proposed rule to assess the

likely public health benefits that the implementation of this rule may

achieve.

Establishments that volunteer for this proposed new inspection system

alternative would likely need to make capital investments in facilities

and equipment. They may also need to add labor (trained employees).

However, one of the beneficial effects of these investments would

likely be the lowering of the average cost per pound to dress poultry

properly. Cost savings would likely result because of increased line

speeds, increased productivity, and increased flexibility to industry.

The expected lower average unit cost for dressing poultry would likely

give a marketing advantage to establishments under the new system.

Consumers would likely benefit from lower retail prices for high

quality poultry products. The rule would also likely provide

opportunities for the industry to innovate because of the increased

flexibility it would allow poultry slaughter establishments. In

addition, in the public sector, benefits would accrue to FSIS from the

more effective deployment of FSIS inspection program personnel to

verify process control based on risk factors at each establishment.

Risks:

Salmonella and other pathogens are present on a substantial portion of

poultry carcasses inspected by FSIS. Foodborne salmonella cause a large

number of human illnesses that at times lead to hospitalization and

even death. There is an apparent relationship between human illness and

prevalence levels for salmonella in young chicken

[[Page 64170]]

carcasses. FSIS believes that through better allocation of inspection

resources and the use of performance standards, it would be able to

reduce the prevalence of salmonella and other pathogens in young

chickens.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 09/00/10

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

State

Agency Contact:

Dr. Daniel L. Engeljohn

Deputy Assistant Administrator, Office of Policy and Program

Development

Department of Agriculture

Food Safety and Inspection Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 205-0495

Fax: 202 401-1760

Email: [email protected]

RIN: 0583-AD32

_______________________________________________________________________

USDA--FSIS

19. NOTIFICATION, DOCUMENTATION, AND RECORDKEEPING REQUIREMENTS FOR

INSPECTED ESTABLISHMENTS

Priority:

Other Significant. Major status under 5 USC 801 is undetermined.

Legal Authority:

21 USC 612 to 613; 21 USC 459

CFR Citation:

9 CFR 417.4; ; 9 CFR 418

Legal Deadline:

None

Abstract:

The Food Safety and Inspection Service (FSIS) is proposing to require

establishments subject to inspection under the Federal Meat Inspection

Act and the Poultry Products Inspection Act to promptly notify the

Secretary of Agriculture that an adulterated or misbranded product

received by or originating from the establishment has entered into

commerce, if the establishment believes or has reason to believe that

this has happened. FSIS is also proposing to require these

establishments to: (1) prepare and maintain current procedures for the

recall of all products produced and shipped by the establishment; and

(2) document each reassessment of the process control plans of the

establishment.

Statement of Need:

The Food, Conservation, and Energy Act of 2008 (Public Law 110-246,

Sec. 11017), known as the 2008 Farm Bill, amended the Federal Meat

Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA) to

require establishments subject to inspection under these Acts to

promptly notify the Secretary that an adulterated or misbranded product

received by or originating from the establishment has entered into

commerce, if the establishment believes or has reason to believe that

this has happened. Section 11017 also requires establishments subject

to inspection under the FMIA and PPIA to: (1) prepare and maintain

current procedures for the recall of all products produced and shipped

by the establishment; and (2) document each reassessment of the process

control plans of the establishment.

Summary of Legal Basis:

21 U.S.C. 612 and 613; 21 U.S.C. 459, and Public Law 110-246, Sec.

11017.

Alternatives:

The option of no rulemaking is unavailable.

Anticipated Cost and Benefits:

Approximate costs: $5.0 million for labor and costs; $5.2 million for

first year costs; $0.7 million average costs adjusted with a 3%

inflation rate for following years. Total approximate costs: $10.2

million. The average cost of this proposed rule to small entities is

expected to be less than one tenth of one cent of meat and poultry food

products per annum. Therefore, FSIS has made an initial determination

that this rule will not have a significant economic impact on a

substantial number of small entities.

Approximate benefits: benefits have not been monetized because

quantified data on benefits attributable to this proposed rule are not

available. Non-monetary benefits include improved protection of the

public health, improved HACCP plans, and improved recall effectiveness.

Risks:

In preparing regulations on the shipment of adulterated meat and

poultry products by meat and poultry establishments, the preparation

and maintenance of procedures for recalled products produced and

shipped by establishments, and the documentation of each reassessment

of the process control plans by the establishment, the Agency will

consider any risks to public health or other pertinent risks associated

with these actions.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 01/00/10

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

Businesses

Government Levels Affected:

None

Agency Contact:

Victoria Levine

Program Analyst, Policy Issuances Division

Department of Agriculture

Food Safety and Inspection Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-5627

Fax: 202 690-0486

Email: [email protected]

RIN: 0583-AD34

_______________________________________________________________________

USDA--FSIS

20. MANDATORY INSPECTION OF CATFISH AND CATFISH PRODUCTS

Priority:

Other Significant

Legal Authority:

21 USC 601 et seq PL 110-249, sec 11016

CFR Citation:

9 CFR ch III, subchapter F (new)

Legal Deadline:

Final, Statutory, December 2009, Final regulations NLT 18 months after

enactment of PL 110-246.

Abstract:

The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, sec.

11016), known as the 2008 Farm Bill, amended the Federal Meat

Inspection Act (FMIA) to make catfish an amenable species under the

FMIA. Amenable species must be inspected, so this rule will define

inspection

[[Page 64171]]

requirements for catfish. The regulations will define ``catfish'' and

the scope of coverage of the regulations to apply to establishments

that process farm-raised species of catfish and to catfish and catfish

products. The regulations will take into account the conditions under

which the catfish are raised and transported to a processing

establishment.

Statement of Need:

The Food, Conservation, and Energy Act of 2008 (Pub. L. 110-246, sec.

11016), known as the 2008 Farm Bill, amended the Federal Meat

Inspection Act (FMIA) to make catfish an amenable species under the

FMIA. The Farm Bill directs the Department to issue final regulations

implementing the FMIA amendments not later than 18 months after the

enactment date (June 18, 2008) of the legislation.

Summary of Legal Basis:

21 U.S.C. 601 to 695 and Public Law 110-246, sec. 11016

Alternatives:

The option of no rulemaking is unavailable. The Agency will consider

alternative methods of implementation and levels of stringency, and the

effects on foreign and domestic commerce and on small business

associated with the alternatives.

Anticipated Cost and Benefits:

FSIS anticipates benefits from uniform standards and the more extensive

and intensive inspection service that FSIS provides (compared with

current voluntary inspection programs). FSIS would apply requirements

for imported catfish that would be equivalent to those applying to

catfish raised and processed in the United States.

Risks:

In preparing regulations on catfish and catfish products, the Agency

will consider any risks to public health or other pertinent risks

associated with the production, processing, and distribution of the

products. FSIS will determine, through scientific risk assessment

procedures, the magnitude of the risks associated with catfish and how

they compare with those associated with other foods in FSIS's

jurisdiction.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 02/00/10

Regulatory Flexibility Analysis Required:

Undetermined

Small Entities Affected:

Businesses

Government Levels Affected:

Federal, State

Agency Contact:

William Milton

Assistant Office of Catfish Inspection Programs

Department of Agriculture

Food Safety and Inspection Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-5735

Fax: 202 690-1742

Email: [email protected]

RIN: 0583-AD36

_______________________________________________________________________

USDA--FSIS

21. ELECTRONIC FOREIGN IMPORT CERTIFICATES AND SANITATION

STANDARD OPERATING PROCEDURES (SOPS) REQUIREMENTS FOR OFFICIAL IMPORT

ESTABLISHMENTS

Priority:

Other Significant

Legal Authority:

Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695), the Poultry

Products Inspection Act (PPIA) (21 U.S.C. 451-470);; Egg Products

Inspection Act (EPIA)(21 U.S.C. 1031-1056)

CFR Citation:

9 CFR 304.3; 9 CFR 327.2, 327.4, ; 9 CFR 381.196, 391.197, 381.198;; 9

CFR 590.915, 590.920

Legal Deadline:

None

Abstract:

FSIS is proposing to amend meat, poultry, and egg products regulations

to provide for the electronic submission of import product and

establishment applications and certificates and delete the

``streamlined'' inspection procedures for Canadian product. In

addition, FSIS is amending its regulations to require Sanitation

Standard Operating Procedures (Sanitation SOPs) in official import

inspection establishments.

Statement of Need:

FSIS is proposing these regulations to provide for the electronic

submission of import product and establishment certificates to allow

the electronic interchange and transmission of data to Agency's

computer-based Public Health Information System (PHIS), which is

currently under development. Providing an electronic format for

imported certificates will enable the government-to-government exchange

of data between FSIS and foreign customs and inspection authorities.

Sanitation SOPs are written procedures that are developed and

implemented by establishments to prevent direct contamination or

adulteration of meat or poultry products. Sanitation SOPs are required

at official (domestic) establishments. Current regulations are

ambiguous concerning Sanitation SOP requirements for official import

inspection establishments. FSIS is proposing to require that official

import inspection establishments comply with the Sanitation SOPs

regulations to eliminate that ambiguity and ensure that products do not

become contaminated as they enter this country.

Summary of Legal Basis:

The authorities for this proposed rule are: the Federal Meat Inspection

Act (FMIA) (21 U.S.C. 601-695), the Poultry Products Inspection Act

(PPIA) (21 U.S.C. 451-470), Egg Products Inspection Act (EPIA)(21

U.S.C. 1031-1056) and the regulations that implement these Acts.

Alternatives:

The electronic processing of import certifications is voluntary,

therefore, importers still have the option of using the current paper-

based system. The Agency is proposing to require that official import

inspection establishments adopt Sanitation SOPs to prevent direct

contamination or adulteration of product. Therefore, no alternatives

were considered.

Anticipated Cost and Benefits:

The opportunity cost of not amending the regulations would hinder the

Agency's implementation of PHIS. The amendments that provide for the

electronic interchange of data are voluntary, so establishments will

not take them on unless the benefits outweigh the costs. It has been

the Agency's expectation that official import establishments will

maintain Sanitation SOPs, this proposed rule codifies that expectation.

Therefore, the proposed amendment on sanitation requirements will have

no costs to the industry. The proposed rule will facilitate FSIS's use

of the PHIS system, enabling the electronic transmission, issuance, and

authorization of imported product data. The PHIS will enable FSIS

import inspection personnel to

[[Page 64172]]

verify and authorize shipments using electronic data, reducing

inspector workload. The electronic exchange of certificate data will

help to reduce the fraudulent alteration or reproduction of

certificates. The Agency estimates that the electronic processing of

import certificates will reduce the data-entry time for import

inspectors, by 50 to 60 percent.

Risks:

None

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 03/00/10

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and

investment effects, or otherwise be of international interest.

Agency Contact:

Clark Danford

Director, International Policy Division, Office of Policy and Program

Development

Department of Agriculture

Food Safety and Inspection Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-9824

RIN: 0583-AD39

_______________________________________________________________________

USDA--FSIS

22. ELECTRONIC EXPORT APPLICATION AND CERTIFICATION AS A

REIMBURSABLE SERVICE AND FLEXIBILITY IN THE REQUIREMENTS FOR OFFICIAL

EXPORT INSPECTION MARKS, DEVICES, AND CERTIFICATES

Priority:

Other Significant

Legal Authority:

Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695); Poultry

Products Inspection Act (PPIA) (21 U.S.C. 451-470); Egg Products

Inspection Act (EPIA) (21 U.S.C. 1031-1056)

CFR Citation:

9 CFR 312.8; 9 CFR 322.1. 322.2, ; 9 CFR 381.104, 381.105, 381.106; 9

CFR 590; 9 CFR 350.3

Legal Deadline:

None

Abstract:

The Food Safety and Inspection Service (FSIS) is proposing to amend the

meat, poultry, and egg product inspection regulations to provide an

electronic export application and certification process that will be

available as an alternative to the paper-based application and

certification method currently in use. The electronic export

application and certification process will be available as a

reimbursable inspection service. FSIS is also proposing to provide

establishments that export meat, poultry, and egg products with

flexibility in the official export inspection marks, and devices used

and how the products are marked for export.

Statement of Need:

FSIS is proposing these regulations to implement the Public Health

Information System (PHIS), a computer-based inspection information

system currently under development. The PHIS will include automation of

the export application and certification process. The current export

application and certification regulations provide only for a paper-

based process, this proposed rule will amend the regulations to provide

for the electronic process. Additionally, this rule is needed to

provide this automated services as a reimbursable certification service

charged to the exporter.

Summary of Legal Basis:

The authorities for this proposed rule are: the Federal Meat Inspection

Act (FMIA) (21 U.S.C. 601-695), the Poultry Products Inspection Act

(PPIA) (21 U.S.C. 451-470), the Egg Products Inspection Act (EPIA) (21

U.S.C. 1031-1056), and the regulations that implement these Acts. FSIS

is proposing the electronic export application and certification

process as a reimbursable service under the Agricultural Marketing Act

7 U.S.C. 1622(h), that provides the Secretary of Agriculture with the

authority to: ``inspect, certify, and identify the class, quality,

quantity, and condition of agricultural products when shipped or

received in interstate commerce, under such rules and regulations as

the Secretary of Agriculture may prescribe, including assessment and

collection of such fees as will be reasonable and as nearly as may be

to cover the cost of the service rendered, to the end that agricultural

products may be marketed to the best advantage, that trading may be

facilitated, and that consumers may be able to obtain the quality

product which they desire.''

Alternatives:

The electronic processing of export applications and certifications is

being proposed as a voluntary service, therefore, exporters have the

option of continuing to use the current paper-based system. Therefore,

no alternatives were considered.

Anticipated Cost and Benefits:

FSIS estimates that it will take inspection personnel 1 hour to process

an electronic application and issue an electronic certificate. Based on

a workload of accessing and processing an estimated 350,000

applications/certificates per year, at a base time rate of $49.93 per

hour, the cost of recouping the inspector's labor costs for 2009 would

be $17.4 million. The amount charged to the exporter depends upon the

number of electronic applications submitted. The use of the electronic

export application and certificate system is voluntary. Therefore,

exporters will not use this service unless the benefits outweigh the

cost. The electronic export application and certificate process will

reduce and expedite industry workload by eliminating the physical

handling and processing of paperwork. The electronic exchange of export

information between the U.S. and foreign governments will help reduce

the fraudulent alternation or reproduction of certificates. The

electronic system will process the applications and certificates will

permit exporters to move their products faster, thereby increasing the

amount of revenues received at a faster rate. The electronic system

will provide a streamlined and integrated method of processing export

applications and certificates.

Risks:

None

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 03/00/10

Regulatory Flexibility Analysis Required:

No

Small Entities Affected:

No

[[Page 64173]]

Government Levels Affected:

None

International Impacts:

This regulatory action will be likely to have international trade and

investment effects, or otherwise be of international interest.

Agency Contact:

Clark Danford

Director, International Policy Division, Office of Policy and Program

Development

Department of Agriculture

Food Safety and Inspection Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 720-9824

RIN: 0583-AD41

_______________________________________________________________________

USDA--FSIS

-----------

FINAL RULE STAGE

-----------

23. PERFORMANCE STANDARDS FOR THE PRODUCTION OF PROCESSED MEAT AND

POULTRY PRODUCTS; CONTROL OF LISTERIA MONOCYTOGENES IN READY-TO-EAT

MEAT AND POULTRY PRODUCTS

Priority:

Economically Significant. Major under 5 USC 801.

Legal Authority:

21 USC 451 et seq; 21 USC 601 et seq

CFR Citation:

9 CFR 301; 9 CFR 303; 9 CFR 317; 9 CFR 318; 9 CFR 319; 9 CFR 320; 9 CFR

325; 9 CFR 331; 9 CFR 381; 9 CFR 417; 9 CFR 430; 9 CFR 431

Legal Deadline:

None

Abstract:

FSIS has proposed to establish pathogen reduction performance standards

for all ready-to-eat (RTE) and partially heat-treated meat and poultry

products, and measures, including testing, to control Listeria

monocytogenes in RTE products. The performance standards spell out the

objective level of pathogen reduction that establishments must meet

during their operations in order to produce safe products but allow the

use of customized, plant-specific processing procedures other than

those prescribed in the earlier regulations. With HACCP, food safety

performance standards give establishments the incentive and flexibility

to adopt innovative, science-based food safety processing procedures

and controls, while providing objective, measurable standards that can

be verified by Agency inspectional oversight. This set of performance

standards will include and be consistent with standards already in

place for certain ready-to-eat meat and poultry products.

Statement of Need:

Although FSIS routinely samples and tests some ready-to-eat products

for the presence of pathogens prior to distribution, there are no

specific regulatory pathogen reduction requirements for most of these

products. The proposed performance standards are necessary to help

ensure the safety of these products; give establishments the incentive

and flexibility to adopt innovative, science-based food safety

processing procedures and controls; and provide objective, measurable

standards that can be verified by Agency oversight.

Summary of Legal Basis:

Under the Federal Meat Inspection Act (21 U.S.C. 601 to 695) and the

Poultry Product Inspection Act (21 U.S.C. 451 to 470), FSIS issues

regulations governing the production of meat and poultry products

prepared for distribution in commerce. The regulations, along with FSIS

inspection programs, are designed to ensure that meat and poultry

products are safe, not adulterated, and properly marked, labeled, and

packaged.

Alternatives:

As an alternative to all of the proposed requirements, FSIS considered

taking no action. As alternatives to the proposed performance standard

requirements, FSIS considered end-product testing and requiring ``use-

by'' date labeling on ready-to-eat products.

Anticipated Cost and Benefits:

Benefits are expected to result from fewer contaminated products

entering commercial food distribution channels as a result of improved

sanitation and process controls and in-plant verification. FSIS

believes that the benefits of the rule would exceed the total costs of

implementing its provisions. FSIS currently estimates net benefits from

the 2003 interim final rule at $470 to $575 million, with annual

recurring costs at $150.4 million, if FSIS discounts the capital cost

at 7%. FSIS is continuing to analyze the potential impact of the other

provisions of the proposal.

The other main provisions of the proposed rule are: Lethality

performance standards for Salmonella and E. coli O157:H7 and

stabilization performance standards for C. perfringens that firms must

meet when producing RTE meat and poultry products. Most of the costs of

these requirements would be associated with one-time process

performance validation in the first year of implementation of the rule

and with revision of HACCP plans. Benefits are expected to result from

the entry into commercial food distribution channels of product with

lower levels of contamination resulting from improved in-plant process

verification and sanitation. Consequently, there will be fewer cases of

foodborne illness.

Risks:

Before FSIS published the proposed rule, FDA and FSIS had estimated

that each year L. monocytogenes caused 2,540 cases of foodborne

illness, including 500 fatalities. The Agencies estimated that about

65.3 percent of these cases, or 1660 cases and 322 deaths per year,

were attributable to RTE meat and poultry products. The analysis of the

interim final rule on control of L. monocytogenes conservatively

estimated that implementation of the rule would lead to an annual

reduction of 27.3 deaths and 136.7 illnesses at the median. FSIS is

continuing to analyze data on production volume and Listeria controls

in the RTE meat and poultry products industry and is using the FSIS

risk assessment model for L. monocytogenes to determine the likely risk

reduction effects of the rule. Preliminary results indicate that the

risk reductions being achieved are substantially greater than those

estimated in the analysis of the interim rule.

FSIS is also analyzing the potential risk reductions that might be

achieved by implementing the lethality and stabilization performance

standards for products that would be subject to the proposed rule. The

risk reductions to be achieved by the proposed rule and that are being

achieved by the interim rule are intended to contribute to the Agency's

public health protection effort.

Timetable:

_______________________________________________________________________

Action Date FR Cite

_______________________________________________________________________

NPRM 02/27/01 66 FR 12590

[[Page 64174]]

NPRM Comment Period End 05/29/01

NPRM Comment Period

Extended 07/03/01 66 FR 35112

NPRM Comment Period End 09/10/01

Interim Final Rule 06/06/03 68 FR 34208

Interim Final Rule

Effective 10/06/03

Interim Final Rule

Comment Period End 01/31/05

NPRM Comment Period

Reopened 03/24/05 70 FR 15017

NPRM Comment Period End 05/09/05

Affirmation of Interim

Final Rule 03/00/10

Final Action 08/00/10

Regulatory Flexibility Analysis Required:

Yes

Small Entities Affected:

Businesses

Government Levels Affected:

Undetermined

Agency Contact:

Dr. Daniel L. Engeljohn

Deputy Assistant Administrator, Office of Policy and Program

Development

Department of Agriculture

Food Safety and Inspection Service

1400 Independence Avenue SW

Washington, DC 20250

Phone: 202 205-0495

Fax: 202 401-1760

Email: [email protected]

RIN: 0583-AC46

_______________________________________________________________________

USDA--FSIS

24. FEDERAL-STATE INTERSTATE SHIPMENT COOPERATIVE INSPECTION PROGRAM

Priority:

Other Significant

Legal Authority:

PL 110-246 (section 11015)

CFR Citation:

Not Yet Determined

Legal Deadline:

Final, Statutory, December 18, 2009.

Abstract:

FSIS is proposing regulations to implement a new voluntary Federal-

State cooperative inspection program under which State-inspected

establishments with 25 or fewer employees would be eligible to ship

meat and poultry products in interstate commerce. State-inspected

establishments selected to participate in this program would be

required to comply with all Federal standards under the Federal Meat

Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA).

These establishments would receive inspection services from State

inspection personnel that have been trained and certified to assist

with enforcement of the FMIA and PPIA. Meat and poultry products

produced under the program that have been inspected and passed by

selected State-inspection personnel would bear a Federal mark of

inspection. FSIS is proposing these regulations in response to the

Food, Conservation, and Energy Act, enacted on June 18, 2008 (the 2008

Farm Bill). Section 11015 of 2008 Farm Bill provides for the interstate

shipment of State-inspected meat and poultry product from selected

establishments and requires that FSIS promulgate implementing

regulations no later than 18 months from the date of its enactment

Statement of Need:

This action is needed to implement a new Federal-State cooperative

program that will permit certain State-inspected establishments to ship

meat and poultry products in interstate commerce. Inspection services

for establishments selected to participate in the

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