Compliance Regulations and Guidance Affecting your Industry

This final rule adopts without change the food safety inspections requirements for the National School Lunch Program (NSLP) and the School Breakfast Program (SBP) set forth in a previous interim rule issued by the Food and Nutrition Service as a result of the Child Nutrition and WIC Reauthorization Act of 2004. Schools participating in the lunch and breakfast programs must obtain two inspections per year, post the most recent inspection report in a visible location, and release a copy of the report to members of the public upon request. This rule enhances the safety of over 38 million meals served to school children daily

 Effective Date: This rule is effective January 14, 2010

This final rule adopts without change the food safety inspections requirements for the National School Lunch Program (NSLP) and the School Breakfast Program (SBP) set forth in a previous interim rule issued by the Food and Nutrition Service as a result of the Child Nutrition and WIC Reauthorization Act of 2004. Schools participating in the lunch and breakfast programs must obtain two inspections per year, post the most recent inspection report in a visible location, and release a copy of the report to members of the public upon request. This rule enhances the safety of over 38 million meals served to school children daily

 Effective Date: This rule is effective October 2, 2009

The Department is adopting as a final rule, without change, an interim rule that amended the regulations for the School Breakfast Program. The interim rule addresses and implements amendments made by Section 201 of the Child Nutrition and WIC Reauthorization Act of 2004 and amends the School Breakfast Program (SBP) regulations to eliminate the requirement that a school’s costs exceed the rate of reimbursement as a criterion for receiving the higher severe need funding available in the SBP. The rule also allows State agencies to provide severe need reimbursements to certain new schools that are beginning participation in the school feeding programs and therefore have no historical second preceding year participation information, as was previously required. The rule is intended to simplify eligibility for severe need reimbursements by removing previous restrictions on receipt of those payments. This rule does not impose new administrative requirements on State or local governmental entities.

 Effective Date: This rule is effective june 15, 2009

This final rule is part of the Department’s effort to fulfill its responsibilities under the Faith-Based and Community Initiative pursuant to Executive Orders 13279 and 13280. Under this rule, State agencies will collect and report information related to institutions and organizations that participate in specified Food and Nutrition Service (FNS) nutrition assistance programs. This information will be a new collection for the affected programs. It will enable FNS to identify the faith-based and community organizations participating in Federal nutrition assistance programs and determine the level of participation of faith-based and community organizations in the programs. It will not adversely impact the application or participation of any organization or institution currently participating in, or seeking to participate in, FNS nutrition assistance programs

 Effective Date:This rule is effective June 1, 2007

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ‘‘Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association.’’ The guidance provides information for seafood processors and other entities that are interested in obtaining export certificates for fish or fishery products that are to be shipped to the European Union (EU) and the European Free Trade Association (EFTA). FDA is also announcing that it intends to stop issuing EU Export Certificates after February 17, 2009.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ‘‘Voluntary Third-Party Certification Programs for Foods and Feeds.’’ This guidance describes the general attributes FDA believes a voluntary third-party certification program should have in order to help ensure its certification is a reliable reflection that the foods and feeds (hereinafter foods) from certified establishments meet applicable FDA requirements, as well as other certification criteria.

The Food and Drug Administration (FDA) is announcing the withdrawal of a guidance entitled ‘‘Guidance for Industry: Significant Scientific Agreement in the Review of Health Claims for Conventional Foods and Dietary Supplements,’’ that was issued December 1999.

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance document entitled ‘‘Guidance for Industry: Referral Program from the Food and Drug Administration to the National Oceanic and Atmospheric Administration Seafood Inspection Program for the Certification of Fish and Fishery Products for Export to the European Union and the European Free Trade Association.’’ The revised guidance only changes the date on which FDA intends to stop issuing export certificates for fish or fishery products that are to be shipped to the European Union (EU) and the European Free Trade Association (EFTA). The date FDA now intends to stop issuing EU Export Certificates is June 17, 2009

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ‘‘Guidance for Industry:Measures to Address the Risk for Contamination by Salmonella Species in Food Containing a Peanut-Derived Product as an Ingredient.’’ This guidance is intended to clarify for manufacturers who produce foods containing a peanutderived product as an ingredient that there is a risk that Salmonella species may be present in the incoming peanutderived product, and to recommend measures to address that risk

The Food and Drug Administration (FDA) is confirming the effective date of January 5, 2011, for the final rule that appeared in the Federal Register of January 5, 2009. The final rule amends the regulations for cochineal extract and carmine by requiring their declaration by name on the label of all food and cosmetic products that contain these color additives. This final rule responds to reports of severe allergic reactions, including anaphylaxis, to cochineal extract-containing food and carminecontaining food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives. This action also responds to a citizen petition submitted by the Center for Science in the Public Interest.

Effective Date: The effective date of the final rule published on January 5, 2009

This rule is effective March 16, 2009. Submit written or electronic objections and requests for a hearing by April 15, 2009. See section VII of this document for information on filing objections. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of March 16, 2009.

Effective Date:This rule is effective March 16,2009

The Food and Drug Administration (FDA) is amending the food additive regulations to provide for the safe use of an aqueous solution of silver nitrate and hydrogen peroxide as an antimicrobial agent in bottled water. This action is in response to a petition filed by Kareem I. Batarseh

The Food and Drug Administration (FDA) is confirming the effective date of April 27, 2009, for the final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ‘‘Substances Prohibited From Use in Animal Food or Feed.’’ The agency is also establishing a compliance date of October 26, 2009, for this rule in order to allow additional time for renderers to comply with the new requirements. This additional time will also give other affected persons, including cattle producers and packers, more time to identify appropriate methods for disposing of material prohibited from use in animal feed by this rule.

Effective Date: The effective date of the final rule published in the Federal Register of April 25, 2008 (73 FR 22720), is April 27, 2009.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #195 entitled ‘‘Small Entities Compliance Guide for Renderers— Substances Prohibited From Use in Animal Food or Feed’’ This small entities compliance guide aids renderers in complying with the requirements of the final rule published in the Federal Register of April 25, 2008 (73 FR 22720). FDA’s goal is to strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle and to reduce the risk of human exposure to the BSE agent.

The Food and Drug Administration (FDA) is correcting a final rule; confirmation of effective date, that appeared in the Federal Register of Friday, April 24, 2009 (74 FR 18626) (the April 24, 2009, final rule; confirmation of effective date). That document had confirmed the effective date of April 27, 2009, for a final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ‘‘Substances Prohibited From Use in Animal Food or Feed.’’ In the April 24, 2009, final rule; confirmation of effective date, the agency also established a compliance date of October 26, 2009, in order to allow additional time for renderers to comply with the new requirements. The April 24, 2009, final rule; confirmation of effective date was published with an inadvertent error in the ‘‘Background’’ section. This document corrects that error .

Effective Date: This correction is effective: May 5 2009

 The Food and Drug Administration (FDA) is correcting a final rule; confirmation of effective date, that appeared in the Federal Register of Friday, April 24, 2009 (74 FR 18626) (the April 24, 2009, final rule; confirmation of effective date). That document had confirmed the effective date of April 27, 2009, for a final rule that published in the Federal Register of April 25, 2008 (73 FR 22720), entitled ‘‘Substances Prohibited From Use in Animal Food or Feed.’’ In the April 24, 2009, final rule; confirmation of effective date, the agency also established a compliance date of October 26, 2009, in order to allow additional time for renderers to comply with the new requirements. The April 24, 2009, final rule; confirmation of effective date was published with an inadvertent error in the ‘‘Background’’ section. This document corrects that error.

The Food and Drug  Administration (FDA) is amending its  bottled water regulations to require that  bottled watermanufacturers test source  water for total coliform, as is required  for finished bottled water products, and  to require, if any coliform organisms are  detected in source water, that bottled  water manufacturers determine whether  any of the coliform organisms are  Escherichia coli (E. coli), an indicator of  fecal contamination. FDA also is  amending its bottled water regulations  to require, if any coliform organisms are  detected in finished bottled water  products, that bottled water  manufacturers determine whether any  of the coliform organisms are E. coli.  FDA also is amending the adulteration provision of the bottled water standard  to reflect the possibility of adulteration  caused by the presence of filth. Bottled  water containing E. coli will be  considered adulterated, and source  water containing E. coli will not be  considered to be of a safe, sanitary  quality and will be prohibited from use  in the production of bottled water. FDA  is also amending its bottled water  regulations to require that, before a  bottler can use source water from a  source that has tested positive for E.  coli, the bottler must take appropriate  measures to rectify or eliminate the  cause of E. coli contamination of that  source, and that the bottler must keep  records of such actions. Existing  regulatory provisionsrequire bottled  water manufacturers to keep records of  new testing required by this rule. This  final rule will ensure that FDA’s  standards for the minimum quality of  bottled water, as affected by fecal  contamination, will be no less  protective of the public health than  those set by the Environmental  Protection Agency (EPA) for public  drinking water.

Effective Date: This rule is effective December 1,2009

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Friday, May 29, 2009 (74 FR 25651). The final rule was published with an inadvertent error in the ‘‘Analysis of Impacts’’ section. This document corrects that error

The Food and Drug  Administration (FDA) is announcing the  Establishment of the Tobacco Products  Scientific Advisory Committee. These  actions are needed to implement the  Federal Food, Drug, and Cosmetic Act,  as amended by the Family Smoking  Prevention and Tobacco Control Act.  Elsewhere in this issue of the Federal  Register, FDA is publishing two  separate documents requesting  nominations for voting and non-voting  membership on this committee. This  document also amends the agency’s  regulations to add the Tobacco Products  Scientific Advisory Committee (the  committee) to the agency’s list of  standing advisory committees.

Effective Date: This rule is effective August 26, 2009
 

The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), establishes a tobacco standard special rule for cigarettes. This special rule for cigarettes prohibits a cigarette or any of its component parts (including the tobacco, filter, or paper) from containing, as a constituent (including a smoke constituent) or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, including strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry, or coffee, that is a characterizing flavor of the tobacco product or tobacco smoke. The Food and Drug Administration (FDA) is providing this notice to remind regulated industry that as of the effective date identified in the FSPTCA, cigarettes that contain certain characterizing flavors are considered adulterated under the act. FDA is also providing in this notice contact information to which individuals who observe violative products after the effective date of the tobacco standard special rule may report their observations to FDA.