Background

The regulations in 9 CFR part 94 prohibit or restrict the importation of certain animals and animal and poultry products into the United States to prevent the introduction of communicable diseases of livestock and poultry. Section 94.9 contains requirements that apply to the importation of pork and pork products from regions where classical swine fever (CSF) exists.

Currently, the regulations provide that pork and pork products may be imported into the United States from regions where CSF exists only if they have been cooked or cured in the affected region as specified in our regulations. This is the case even if the pork or pork products originated in a region free of CSF but were imported through a region where CSF exists.

We are proposing to allow the importation, under certain conditions, of uncooked pork and pork products from regions where CSF is considered to exist if the pork and pork products originate in a region free of CSF. The primary purpose of this proposed change is to allow uncooked pork and pork products that originate in the United States to be shipped for processing to Mexico, which contains areas where CSF is considered to exist, and then be returned to the United States. 1 The proposal would, however, also allow uncooked pork and pork products that originate in another CSF-free region to be processed in a region where CSF is considered to exist and then be shipped to the United States. If the region of origin is free of CSF but affected with another serious livestock disease such as African swine fever (ASF), swine vesicular disease (SVD), foot-and-mouth disease (FMD), or rinderpest, the existing regulations for the importation of products from regions affected with those diseases would continue to govern imports from that region. This action would remove some restrictions on the importation of uncooked pork and pork products from regions where CSF is considered to exist while continuing to provide appropriate safeguards against an incursion of CSF into the United States.

Under this proposed rule, uncooked pork or pork products that originate in a region free of CSF would have to be shipped for processing to the region where CSF is considered to exist in closed containers sealed with serially numbered seals applied by an official of the national government of the region of origin. The shipments would have to be accompanied by a certificate that was signed by an official of the national government of the region of origin and that specifies the products' region of origin, the slaughtering establishment where the animal was slaughtered and from which the products were shipped, the processing establishment to which the products are consigned, and the numbers of the seals applied to the shipping containers.

Upon arrival at the processing establishment, the uncooked pork or pork products could only be removed from the containers after an official of the national government of the region where the processing establishment is located had determined that the seals were intact and free of any evidence of tampering and the shipment is accompanied by the certificate described above.

Under this proposed rule, the uncooked pork or pork products would be eligible for importation to the United States only if they were handled and processed in accordance with the following criteria:

1. The processing establishment in a region where CSF is considered to exist would have to meet requirements of the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ) and the regulations of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA) in 9 CFR, chapter III, part 327. FSIS periodically audits foreign country inspection systems, including a sample of establishments, to make sure that all FSIS requirements are met. If there is indication that any FSIS requirements are not being met by a particular establishment, FSIS can terminate the eligibility of the foreign establishment to import its products into the United States as well as refuse entry of shipments that fail to meet their requirements. FSIS can issue a hold order to inspect shipments of pork and pork products coming from that establishment until they are certain that all FSIS requirements are being met.

2. The processing establishment that processes the uncooked pork and pork products for export to the United States could not receive or process any live swine, since CSF is easily spread in environments where swine are held or slaughtered.

3. The processing establishment would have to be dedicated to processing uncooked pork and pork products from CSF-free regions. No pork or pork products that originate in regions where CSF is considered to exist could be processed at the same facility as pork or pork products from CSF-free regions.

4. Operators of processing establishments would have to sign a compliance agreement with the Animal and Plant Health Inspection Service (APHIS), stating that all meat processed for importation to the United States would be processed in accordance with our requirements, that a full-time, salaried meat inspection official of the national government of the region where the processing facility is located would supervise the processing and examination of the product and certify that it has been processed in accordance with our requirements, and that APHIS personnel or other persons authorized by the Administrator may enter the establishment, unannounced, to inspect the establishment and its records.

5. The establishment operator or a party acting on its behalf would have to enter into a cooperative service agreement with APHIS to ensure that all expenses incurred by APHIS in inspecting the establishment would be paid by the operators of the processing establishment. APHIS anticipates that an initial evaluation would be conducted and that subsequent inspections would occur approximately once a year. The cooperative service account would be required to contain a balance at least equal to the cost of one inspection. APHIS would charge the cooperative service account for travel, salary, and subsistence of APHIS employees, as well as administrative overhead and other incidental expenses (including excess baggage charges up to 150 pounds).

In addition, the signed certificate which accompanied the shipment would have to be kept on file at the processing establishment for at least 2 years after the export of the processed products to the United States, and would have to be made available to USDA inspectors to demonstrate compliance with our regulations, when requested, during announced or unannounced inspections.

Uncooked pork and pork products to be imported into the United States would have to be shipped from the region where they were processed in closed containers sealed with serially numbered seals applied by an official of the national government of that region. The shipments would have to be accompanied by a certificate signed by an official of the national government of the region where the uncooked pork and pork products were processed. The certificate would have to list the numbers of the seals applied; state that all of the conditions listed above have been met; and state that when the uncooked pork or pork products arrived at the processing establishment, the seals on the containers were intact and free of any evidence of tampering. A copy of this certificate would also have to be kept on file at the processing establishment for at least 2 years after the products were shipped to the United States.

We believe the conditions described above would ensure that the uncooked pork and pork products present a minimal risk of introducing CSF into the United States.

This proposed rule has been reviewed under Executive Order 12866. The rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.

We are proposing to amend the regulations for importing animal products to allow the importation of uncooked pork and pork products from regions where CSF is considered to exist if the uncooked pork and pork products originate in a region free of CSF and meet certain other conditions with respect to processing and shipping. This action would remove some restrictions on the importation of uncooked pork and pork products from regions where CSF is considered to exist while continuing to protect against an incursion of CSF into the United States. We expect the benefits of this rule to exceed costs, although neither benefits nor costs are likely to be significant.

The United States is a major producer as well as trader of swine and swine products. Total cash receipts from hogs and pigs were $15 billion in 2003, about 11 percent over the previous year. Marketing totaled 27.2 billion pounds in 2005. 2 The United States exported a total of 1,811 million pounds valued at $2,068 million in 2005. Although exports are widely distributed, a few regions represent major markets. The major destinations include Japan (51.28 percent), Mexico (14.54 percent), Canada (13.06 percent), South Korea (6.47 percent), Russia (2.58 percent), Australia (2.38 percent), Romania (2.29 percent), and Taiwan (1.55 percent). These regions accounted for 94.15 percent of U.S. fresh or frozen pork exports in 2005. The most recent data (January-September 2006) also show the same pattern, with the above-named regions accounting for 93.96 percent of U.S. total fresh or frozen pork exports during that period. 3

The United States imported 793 million pounds of fresh or frozen pork valued at $945 million in 2005. Most of the imports were from Canada (78.93 percent) and Denmark (16.40 percent). Other regions that supplied pork include Ireland (1.29 percent), United Kingdom (1.14 percent), Netherlands (0.99 percent), Finland (0.51 percent), Sweden (0.25 percent), Australia (0.01 percent), Mexico (0.45 percent), and Germany (0.03 percent). The 2006 (January-September) imports also show the same pattern. The United States imported 566 million pounds of fresh or frozen pork valued at $655 million for this partial year. (See table 1.)

The Regulatory Flexibility Act requires that agencies consider the economic impact of their rules on small entities. We expect the impact of this rule for businesses large and small to be insignificant, but note here that the main industries that could be affected—meat processing (NAICS 311612) and meat and meat product merchant wholesalers (NAICS 424470)—are primarily composed of small entities. Under Small Business Administration (SBA) standards, meat processing establishments with no more than 500 employees and meat and meat product wholesalers with no more than 100 employees are considered small. In 2002, there were 1,335 companies in the United States that processed and sold meat. More than 97 percent of these establishments are considered to be small entities and had average sales of $15.4 million, while large meat processors had average sales of $188 million. In 2002, there were 2,535 meat and meat product wholesalers in the United States. Of these establishments, 2,456 (97 percent) employed not more than 100 employees and are, thus, considered small by SBA standards. Small wholesalers had average sales of $9.3 million, while large entities had average sales of $131 million. 4

Additionally, entities that produce hogs and pigs (NAICS 112210) could also be affected. 5 There were 82,028 such farms with sales of hogs. About 94 percent of these farms are considered to be small. The majority of entities that could be affected by the proposed changes would be small entities. The magnitude of impact would depend on the extent of an increase in U.S. trade with regions affected with CSF, especially with Mexico.

As indicated above, the rule would allow uncooked pork and pork products that originate in the United States to be shipped for processing to Mexico, which contains areas where CSF is considered to exist, and then be returned to the United States. As the Mexican Government and U.S. pork producers are the entities that have requested this proposed rule, this trade may increase under the proposed rule, but we are unable to predict the size of the increase. Pork imports from Mexico accounted only for 0.45 percent (in terms of value and only 0.29 percent in terms of volume) of total imports in 2005.

To illustrate the very small impact that the rule is expected to have on the U.S. economy, we estimate that a doubling of pork imports from Mexico in 2005 (including products that originate in the United States), that is, an increase from 2.29 million pounds to 4.58 million pounds, would result in our domestic production of pork declining by only 0.013 percent and the quantity demanded increasing by only 0.011 percent. The estimated quantity changes, as well as the insignificant price effect and the welfare impacts, are shown in Table 2. We estimate in this example that the annual net welfare gain of this outcome of the rule for the United States would equal about $92,000.

Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ), the information collection or recordkeeping requirements included in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB). Please send written comments to the Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503. Please state that your comments refer to Docket No. APHIS-2006-0186. Please send a copy of your comments to: (1) Docket No. APHIS-2006-0186, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238, and (2) Clearance Officer, OCIO, USDA, room 404-W, 14th Street and Independence Avenue, SW., Washington, DC 20250. A comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication of this proposed rule.

This proposed rule would allow the importation of uncooked pork and pork products from regions where CSF is considered to exist provided the uncooked pork and pork products originate in a region free of CSF and meet certain other conditions with respect to processing and shipping. Allowing such importations will necessitate the use of several information collection activities, including certificates, compliance agreements, cooperative service agreements, and recordkeeping requirements. These information collection activities would aid in our efforts to ensure that uncooked pork and pork products processed in regions where CSF exists do not pose a disease incursion threat when imported into the United States.

We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:

(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;

(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology; e.g., permitting electronic submission of responses).

Estimate of burden: Public reporting burden for this collection of information is estimated to average 0.5 hour per response.

Respondents: Federal animal health authorities in Mexico.

Estimated annual number of respondents: 5.

Estimated annual number of responses per respondent: 50.

Estimated annual number of responses: 250.

Estimated total annual burden on respondents: 30 hours. (Due to averaging, the total annual burden hours may not equal the product of the annual number of responses multiplied by the reporting burden per response.)

Copies of this information collection can be obtained from Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Mrs. Celeste Sickles, APHIS' Information Collection Coordinator, at (301) 734-7477.

Accordingly, we propose to amend 9 CFR part 94 as follows:

The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of certain animals and animal products into the United States in order to prevent the introduction of various diseases, including rinderpest, foot-and-mouth disease (FMD), African swine fever, classical swine fever, and swine vesicular disease. These are dangerous and destructive communicable diseases of ruminants and swine. Section 94.1 of the regulations lists regions of the world that are declared free of rinderpest or free of both rinderpest and FMD. Rinderpest or FMD exists in all other parts of the world not listed. Section 94.11 of the regulations lists regions of the world that have been determined to be free of rinderpest and FMD, but that are subject to certain restrictions because of their proximity to or trading relationships with rinderpest-or FMD-affected regions.

We are proposing to amend the regulations in § 94.1 by adding that portion of the Patagonia region of Argentina located south of latitude 42° south (referred to below as Patagonia South) to the list of regions that are considered free of both rinderpest and FMD. We are proposing this because there has been no outbreak of FMD in the Patagonia South region of Argentina since 1976 and there is no evidence that there are any species currently infected with FMD in Patagonia South. In addition, because rinderpest has never been diagnosed in Argentina and is not endemic to that region of the world, we are also proposing to recognize Patagonia South as free of rinderpest. Finally, we are proposing to amend the regulations in § 94.11 by adding Patagonia South to the list of regions that are subject to certain import restrictions on meat and meat products because of their proximity to or trading relationships with rinderpest-or FMD-affected regions.

Using information submitted to us by the Federal Government of Argentina through the Servicio Nacional de Sanidad y Calidad Agroalimentario (SENASA), as well as information gathered during a site visit by APHIS staff to Argentina in December 2003 and published reports, we have reviewed and analyzed the animal health status of Patagonia South relative to rinderpest and FMD. This review and analysis was conducted in light of the factors identified in our regulations in 9 CFR 92.2, “Application for recognition of the animal health status of a region,” which are used to evaluate the risk associated with importing animals or animal products into the United States from a given region. Based on the information submitted to us, we have concluded the following:

The veterinary services authorities in Argentina have the legal authority, organization, and infrastructure to detect, control, and eradicate FMD. Argentina's veterinary services are organized under SENASA, which translates in English to the National Health and Agrifood Quality Service. SENASA is divided into several sections, four of which focus on animal health issues: (1) The National Animal Health Office (DNSA), which is responsible for animal health control and eradication programs; (2) the National Agrifood Inspection Office (DNFA), which is responsible for enforcing hygiene and health requirements in slaughter establishments, processing plants, and storage facilities for animal and plant products and byproducts; (3) the Quarantine, Borders and Certification Unit (CCFyC), which oversees animal and plant quarantine and border movements and control; and (4) the Laboratories and Technical Control Office (DILACOT), which operates the national reference laboratory for food safety and animal and plant health, and manages regional laboratories and laboratories accredited by SENASA. Additional support for the animal health system in Argentina comes from 349 local animal health offices, 10 of which are located in the Patagonia South region.

In 2003, SENASA reported a total of 3,479 employees, including personnel who deal with plant issues. Of these, 2,558 were permanent staff members, of which 572 were veterinarians. SENASA has the authority to hire contract personnel, including veterinarians and animal health technicians, and to call on private veterinary practitioners, police, and local authorities to provide support to the Central Veterinary Office in depopulating infected premises, disposing of animal carcasses, and controlling and restricting animal movements. In 2003, SENASA reported a complement of 921 contractors, of which 219 were contract veterinarians. SENASA's permanent staff in Patagonia South includes 12 veterinarians, 20 veterinary inspectors, 19 provincial veterinarians, 202 private veterinarians, 20 technicians, and a number of administrative personnel.

SENASA personnel are distributed among 25 regions within Argentina, each of which falls under the supervision of a regional supervisor. In the event of an animal disease emergency, SENASA has the legal authority to implement control measures.

Rinderpest has never been diagnosed in Argentina and is not endemic to that region of the world. The last outbreak of FMD in the Patagonia South region of Argentina occurred in October 1976 and was traced to its origin north of 42° South. There is no evidence that there are any species currently infected with FMD in Patagonia South.

Argentina has a structured system of notification and official involvement to investigate any suspected cases of FMD. Argentina maintains an active FMD surveillance program to monitor viral activity in various FMD-susceptible species. Surveillance for FMD in Patagonia South is conducted under the national surveillance program in Argentina and includes both active and passive surveillance for the disease. Argentina's surveillance program is adequate to detect disease and identify and measure FMD activity in the region.

Argentina has the authority, personnel, and diagnostic capabilities to test herds for, and diagnose, FMD. Currently, there is one diagnostic laboratory in Argentina, located in Buenos Aires, that is authorized to perform FMD diagnostic and surveillance activities. This laboratory meets the biosafety requirements established by SENASA, as well as the biosafety guidelines issued by the World Organization for Animal Health (OIE). The OIE is recognized by the World Trade Organization as the international organization responsible for the development of standards, guidelines, and recommendations with respect to animal health and zoonoses (diseases that are transmissible from animals to humans).

Vaccination against FMD is not practiced and has never been systematically applied in Patagonia South. In the event of a confirmed FMD outbreak in Patagonia South, the primary control measure would be to stamp out affected animals and contacts. Emergency vaccination against FMD may be undertaken in the event of a risk of an extensive outbreak of the disease. Emergency vaccination against FMD was last implemented in Patagonia South during the outbreak of FMD in 1976.

Patagonia South is bordered by the Atlantic Ocean and shares land borders with Chile and the province of Rio Negro, Argentina. The province of Rio Negro, Argentina, is located in “Patagonia North B,” which is an FMD surveillance area situated to the north of Patagonia South. The last outbreak of FMD in Patagonia North B occurred in 1994. Chile is recognized by APHIS as free of FMD.

Patagonia South is sufficiently separated from Patagonia North B by mountains and other natural barriers; however, for the few areas where there are no natural barriers, government control measures compensate. These control measures include mobile patrols and a permanent coordination between national and provincial entities to maintain a constant presence at the region route controls by the National Border Police and other police authorities.

The movement of animals and animal products into Patagonia South from regions of higher disease risk is strictly controlled. The Government of Argentina has established a sanitary barrier across the entire line of latitude 42° South to preserve the FMD-free status of Patagonia South. Movement of FMD-susceptible animals to Patagonia South is not allowed from any region of Argentina other than Patagonia North B. Imports from Patagonia North B to Patagonia South are allowed, provided that certain import requirements are met.

There are 45 animal inspection border posts located in Argentina with SENASA personnel on duty at each to inspect animal products. All live animals and animal products imported into Argentina require an animal health permit issued by SENASA. In addition, all live animals imported into Argentina are placed in quarantine for 15 to 60 days, depending on the length of time it takes to complete required testing procedures, and are observed on the farm of destination for a period of 60 days.

Patagonia South shares an international land border with only one country: Chile. There are three animal inspection border posts located along this border. The animal health status of Chile and Patagonia South are equivalent. Breeding stock and commercial meat shipments are traded between these two regions.

Sheep production is the primary livestock production system in Patagonia South. In 2003, Patagonia South had approximately 7.49 million sheep, 265,960 head of cattle, 12,731 pigs, and 141,614 goats. Each province has established standards for identifying and tracking animals. There is no known feature of livestock production in the region that increases the risk of disease spread.

FMD is a compulsorily notifiable disease in Argentina. The veterinary services in Argentina possess the authority, diagnostic capability, and personnel to rapidly detect, contain, and eradicate any incursion of FMD that might occur.

These findings are described in further detail in a risk analysis that may be obtained by contacting the person listed under FOR FURTHER INFORMATION CONTACT . This analysis may also be viewed on the Internet on the Regulations.gov Web site (see ADDRESSES above for information about accessing documents on Regulations.gov). The risk analysis documents the factors that have led us to conclude that Patagonia South is free of FMD. As noted previously, rinderpest has never occurred in Argentina and is not endemic to the Americas. Therefore, we are proposing to recognize Patagonia South as free of rinderpest and FMD and add the region to the list in § 94.1(a)(2) of regions that are considered free of rinderpest and FMD.

These proposed actions would relieve certain restrictions due to FMD and rinderpest on the importation into the United States of certain live animals and animal products from Patagonia South. However, because Patagonia South shares common land borders with a region of Argentina not considered free of rinderpest and FMD under the regulations, the importation of meat and other products from ruminants and swine into the United States from Patagonia South would continue to be subject to certain restrictions.

Specifically, we are proposing to add Patagonia South to the list in § 94.11(a) of regions declared free of rinderpest and FMD but that are subject to special restrictions on the importation of their meat and other animal products into the United States. The regions listed in § 94.11(a) are subject to these special restrictions because they: (1) Supplement their national meat supply by importing fresh (chilled or frozen) meat of ruminants or swine from regions that are designated in § 94.1(a) as regions where rinderpest or FMD exists, (2) have a common land border with regions where rinderpest or FMD exists, or (3) import ruminants or swine from regions where rinderpest or FMD exists under conditions less restrictive than would be acceptable for importation into the United States.

Patagonia South has a common land border with a region (Patagonia North B) not considered free of FMD. As a result, there is some risk that the meat and other animal products produced in Patagonia South could be commingled with the fresh (chilled or frozen) meat of animals from a region in which FMD exists and present an undue risk of introducing FMD into the United States if imported without restriction.

Under § 94.11, meat and other animal products of ruminants and swine, including ship stores, airplane meals, and baggage containing these meat or animal products, may not be imported into the United States except in accordance with § 94.11 and the applicable requirements of the USDA's Food Safety and Inspection Service at 9 CFR chapter III.

Section 94.11 generally requires that the meat and other animal products of ruminants and swine be: (1) Prepared in an inspected establishment that is eligible to have its products imported into the United States under the Federal Meat Inspection Act; (2) accompanied by a Department-approved meat inspection certificate; and (3) accompanied by an additional certificate, issued by a full-time salaried veterinary official of the national government of the exporting region, assuring that the meat or other animal products have not been commingled with or exposed to meat or other animal products originating in, imported from, transported through, or that have otherwise been in a region where rinderpest or FMD exists.

The proposed changes discussed in this document would update the disease status of Patagonia South with regard to rinderpest and FMD while continuing to protect the United States from an introduction of those diseases by providing additional requirements for any meat and meat products imported into the United States from Patagonia South.

This proposed rule has been reviewed under Executive Order 12866. For this action, the Office of Management and Budget has waived its review under Executive Order 12866.

This proposed rule would recognize the Patagonia South region of Argentina free of FMD and rinderpest. As such, this proposed rule would allow ruminants and ruminant products to be imported from this region into the United States, provided all other import requirements are satisfied. In the following initial regulatory flexibility analysis, we estimate the welfare effects of the proposed rule, as well as consider potential effects of the proposed rule on small entities, as required by the Regulatory Flexibility Act.

While the proposed rule would allow the importation of all ruminants and ruminant products from the Patagonia South region, APHIS expects the rule to result in imports of lamb, mutton, and goat meat, with the overwhelming majority being lamb and mutton. According to information supplied by the government of Argentina, and supported in an APHIS risk assessment and by site visits, bovine production in Patagonia South is consumed locally. In fact, matured and deboned beef is imported to meet the consumption demands of the population in this region. On the other hand, the sheep industry in Patagonia South is the prevailing livestock activity, with this region producing almost 60 percent of the entire sheep population in Argentina. The government of Argentina forecasts that it would export an average of 6,000 metric tons per year (or 13.2 million pounds) of sheep meat to the United States, with a maximum of 9,000 MT per year (or 19.8 million pounds) and a minimum of 4,000 MT per year (or 8.8 million pounds). 1

The U.S. sheep and wool industries have been marked by smaller inventories, declining production, shrinking revenues, and fewer operations over the last few decades. In fact, the United States is a net importer of lamb and mutton and relies on imports to meet domestic consumption demands. For example, in 2005, imports of lamb and mutton totaled 177 million pounds, and accounted for 47 percent of total supply, which was 372 million pounds. U.S. exports of lamb and mutton in 2005 totaled only 10 million pounds. Total reported consumption for that same year was 352 million pounds. 2

We use a non-spatial, partial equilibrium welfare model to quantitatively estimate the economic effects of the proposed rule, referred to as welfare effects. This model measures expected changes in consumer surplus and producer surplus attributable to the rule. Consumer surplus is the difference between what a consumer would be willing to pay for a good or service and what that consumer actually has to pay, and producer surplus is the difference between what a supplier is paid for a good or service and what it cost to supply. Thus, the net expected effects of the proposed rule can be summed up by examining changes in consumer and producer surplus.

We estimate the welfare effects of the proposed rule for three import quantity scenarios: (1) Average imports of 13.2 million pounds annually; (2) a low-end estimate of 8.8 million pounds annually; and (3) a high-end estimate of 19.8 million pounds annually. The baseline quantities and price we use are from 2005: U.S. consumption, 352 million pounds; U.S. production, 192 million pounds; U.S. domestic supply, 3 182 million pounds; and a wholesale carcass price of $209.80 per cwt, or $2.09 per pound. 4 In addition, we use a demand elasticity of −0.729 for lamb and mutton, and a supply elasticity of 0.14. 5 Table 1 presents the expected effects of the proposed rule, as measured by changes in consumer and producer surplus, for the three import scenarios.

Since the Government of Argentina estimates it would export an average of 6,000 MT per year (or 13.2 million lbs) of lamb and mutton to the United States, we focus on the implications of the rule using this scenario.

The proposed rule may result in about a 4.7 percent reduction in the domestic wholesale price of lamb and mutton, or a price decline of about 10 cents per pound. The domestic sheep and lamb industry would be directly impacted by this price decline, as indicated by the annual $17.7 million loss in producer surplus. In 2004, there were 2,679,000 sheep and lambs and 582,000 goats slaughtered in the United States. 6 If we assume the same number were slaughtered in 2005, and given that there were 68,280 sheep and goat farms in the United States last year, we approximate that the number of animals sold for slaughter averaged about 50 head per farm. Assuming an average dressed carcass weight of 75 pounds per lamb sold and a price of $209.80 per cwt yields an approximate average annual revenue of $7,868 per farm. 7 Thus, a 4.7 percent reduction in the wholesale price of lamb and mutton, a decline of $7.40 per animal, would result in a decrease in annual revenue of about $370 per farm, assuming average annual sales of 50 head.

Other factors may also minimize effects of the proposed rule for producers. First, we assume that Patagonia South would be primarily engaging in the export of lamb meat. In the event that they decide to export large quantities of mutton, which is primarily used in the industrial market, such as for pet food, the potential price impacts of the proposed rule would be much less. The wholesale price of mutton meat is less than half that of the wholesale price of lamb meat. 8

Secondly, historically, lamb and mutton are viewed as byproducts of wool production for domestic producers. As such, if wool prices are high, producers would keep lambs longer to get additional shearing of wool, which would mean fewer animals would be sent to slaughter and lamb and mutton production would fall. 9 The high correlation between wool prices and lamb and mutton production may serve to explain the inelasticity of supply. As indicated, the farm-level supply of lamb and mutton is highly inelastic, that is, producers are relatively unresponsive to price changes. 10 Thus, this may illustrate that farm-level production decisions are dictated more by changes in the price of wool than by changes in the wholesale price of lamb and mutton. The analysis shows that with the proposed rule there may be a decrease in the price of lamb of 4.7 percent, suggesting a decrease in supply of about 0.66 percent. 11 So, in the case of high wool prices, the potential impacts of the proposed rule may be even smaller than described.

Thirdly, the estimated welfare gains and losses assume that none of the lamb and mutton meat imported from the Patagonia South region would substitute for, or displace, U.S. imports from other countries. In the case that such displacement may occur, the estimated price impacts of the proposed rule for sheep and lamb producers and other U.S. entities would be smaller than depicted.

The reduction in price of lamb and mutton would benefit domestic purchasers. As the model demonstrates, the annual change in consumer surplus as a result of the rule would be an increase of about $35 million. This benefit would be realized at the wholesale level, but at least a portion of this gain may be passed on to subsequent retail buyers of lamb and mutton. We estimate the annual net benefit of the proposed rule would be about $17.2 million.

The proposed rule would have direct effects on domestic sheep and goat producers, specifically those engaged in lamb and mutton production. In 2005 there were 68,280 sheep, lamb, and goat farms. 12 Inventory and value estimates for 2005 were 6.1 million sheep, with a total value of over $799 million, and 274,000 angora goats, with a total value of over $16 million. 13 Additionally, in 2005 there were 192 million pounds of lamb and mutton produced domestically. 14

The U.S. Small Business Administration's (SBA) size standard for sheep and goat farming is $750,000 or less in annual receipts. 15 The exact number of sheep and goat operations that would be considered small by SBA standards is unknown. However, the 2002 Census of Agriculture estimated there were 150 sheep and lamb farms with inventories of 5,000 or more. The value per head for sheep and lambs in 2002 was $94. 16 From this, we approximate that only 150 farms, or less than 1 percent, had total market values of $470,000 or more annually. This value is well below the small-entity threshold, and moreover, represents the 2002 inventory value of the largest holdings, not their annual receipts. Therefore, it is clear most sheep and goat operations are small.

Other industries that may be affected by the proposed rule, as categorized in the North American Industry Classification System (NAICS), are Meat and Meat Product Merchant Wholesalers (NAICS 424470), Supermarkets and Other Grocery (except Convenience) Stores (NAICS 445110), and Meat Markets (NAICS 445210). All of these industries primarily consist of small entities. 17 The first of these industries includes meat importers, who may directly benefit by the availability of lamb and mutton from the Patagonia South region. Other wholesale buyers of lamb and mutton may also benefit from the expected decline in price of lamb and mutton as a result of the proposed rule. Grocery stores and meat markets may also gain, depending on the extent to which decreases in wholesale prices are passed forward to the retail level.

There are no projected reporting, recordkeeping, or other compliance requirements that small entities will be subject to as a result of implementing the proposed rule. (See “Paperwork Reduction Act” below).

This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.

This proposed rule contains no information collection or recordkeeping requirements under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Accordingly, we propose to amend 9 CFR part 94 as follows:

During a public meeting held on November 15, 2006, the State of Pennsylvania and the Nuclear Energy Institute (NEI) requested that the comment period for the proposed rulemaking be extended by 45 days. Subsequently, on November 17, 2006, the NEI provided a written request to NRC for a 60-day extension to the public comment period for both the proposed rulemaking and the information collection aspects of the rulemaking. NEI stated four reasons to support their request (listed below):

(1) There are two major holidays during the comment period;

(2) This is a major and complex rulemaking as evidenced by the sheer volume of the rulemaking package (SECY-06-0126 exceeds 1000 pages);

(3) Since June 2006, NEI has been engaged in the development of NEI 06-12, “B.5.b Phase 2&3 Submittal Guideline” which licensees will use to respond to the NRC site-specific Phase 3 letters. Licensee responses are due in early January 2007; and,

(4) Comments on the proposed § 73.21 rulemaking are due January 2, 2007.

In view of the NRC's desire to receive high quality comments from external stakeholders, and recognizing the extenuating circumstances that adversely impact the capability of external stakeholders to comment on the proposed rulemaking given ongoing activities which are competing for the same industry resources, the comment period, for both the proposed rulemaking and for the information collections analysis, will be extended for an additional 45 days. This partial grant of the request from both NEI and the State of Pennsylvania recognizes that the power reactor security requirements impact new reactor applications, and it is the NRC's objective to not adversely impact new reactor applications which are scheduled to be submitted in late 2007.

The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. The streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and Federal Register requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products.

This proposed AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The proposed AD contains text copied from the MCAI and for this reason might not follow our plain language principles.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2006-26496; Directorate Identifier 2006-CE-81-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The Civil Aviation Authority of New Zealand, which is the aviation authority for New Zealand, has issued AD DCA/R2000/38, dated June 29, 2006 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states that there have been instances indicating that production aircraft may not have a metal barrier between the cabin and the fuel tank bay. Lack of a barrier could allow flammable fuel vapors to enter the cabin. The MCAI requires that, to ensure that the aircraft is in compliance with 14 CFR 23.967(d), inspect the aircraft to determine if a metal barrier is installed behind the seats and, if not installed, to manufacture and install a barrier. You may obtain further information by examining the MCAI in the AD docket.

Alpha Aviation Design Limited has issued Alpha Aviation Service Bulletin AA-SB-28-001, dated July 10, 2006. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the proposed AD. These requirements, if ultimately adopted, will take precedence over the actions copied from the MCAI.

Based on the service information, we estimate that this proposed AD would affect about 10 products of U.S. registry. We also estimate that it would take about 3 work-hours per product to comply with the proposed AD. The average labor rate is $80 per work-hour. Required parts would cost about $300 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $5,400, or $540 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

Streamlined Issuance of AD

The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. The streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and Federal Register requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products.

This proposed AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The proposed AD contains text copied from the MCAI and for this reason might not follow our plain language principles.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2006-26489; Directorate Identifier 2006-CE-74-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued Emergency Airworthiness Directive AD No. 2006-0348-E, dated November 20, 2006, referred to after this as “the MCAI”, to correct an unsafe condition for the specified products. The MCAI states:

EADS SOCATA has issued MS760 Aircraft Mandatory Service Bulletin SB SB 76-053, ATA No. 30, dated October 2006. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the proposed AD. These requirements, if ultimately adopted, will take precedence over the actions copied from the MCAI.

Based on the service information, we estimate that this proposed AD would affect about 41 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $3,280, or $80 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. The streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act and Federal Register requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products.

This proposed AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The proposed AD contains text copied from the MCAI and for this reason might not follow our plain language principles.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2006-26497; Directorate Identifier 2006-CE-82-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, to http:// dms.dot.gov , including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community, has issued EASA AD 2006-0317, dated October 16, 2006, referred to after this as “the MCAI”, to correct an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket.

Allstar PZL Glider Sp. Z o.o. has issued Mandatory Service Bulletin No. BE-057/SZD-50-3/2006 “PUCHACZ”, dated October 16, 2006. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the proposed AD. These requirements, if ultimately adopted, will take precedence over the actions copied from the MCAI.

Based on the service information, we estimate that this proposed AD would affect about 8 products of U.S. registry. We also estimate that it would take about 2 work-hours per product to comply with the proposed AD. The average labor rate is $80 per work-hour. Required parts would cost about $100 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $2,080, or $260, per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Program,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA is implementing a new process for streamlining the issuance of ADs related to MCAI. The streamlined process will allow us to adopt MCAI safety requirements in a more efficient manner and will reduce safety risks to the public. This process continues to follow all FAA AD issuance processes to meet legal, economic, Administrative Procedure Act, and Federal Register requirements. We also continue to meet our technical decision-making responsibilities to identify and correct unsafe conditions on U.S.-certificated products.

This proposed AD references the MCAI and related service information that we considered in forming the engineering basis to correct the unsafe condition. The proposed AD contains text copied from the MCAI and for this reason might not follow our plain language principles.

We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2006-26493; Directorate Identifier 2006-CE-78-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

We will post all comments we receive, without change, to http://dms.dot.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

The Civil Aviation Authority of New Zealand, which is the aviation authority for New Zealand, has issued AD DCA/R2000/32, Effective Date: June 29, 2006 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states: “an occurrence of inadvertent manipulation of the fuel shut-off control has been reported.” The MCAI requires installing a protector on the fuel shut-off control. You may obtain further information by examining the MCAI in the AD docket.

Robin Aviation (current type certificate responsibility with Alpha Aviation Design Limited) has issued Imperative Service Bulletin No. 180, dated March 20, 2001. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.

This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.

We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.

We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are described in a separate paragraph of the proposed AD. These requirements, if ultimately adopted, will take precedence over the actions copied from the MCAI.

Based on the service information, we estimate that this proposed AD would affect about 10 products of U.S. registry. We also estimate that it would take about 1 work-hour per product to comply with the proposed AD. The average labor rate is $80 per work-hour. Required parts would cost about $400 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these costs. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $4,800, or $480 per product.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify this proposed regulation:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and

3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.

Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

The FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. Please include the regulatory docket or amendment number on your comments, and if you mail or hand deliver your comments, send two copies. We will file all comments received, as well as a report summarizing each substantive public contact with FAA personnel on this rulemaking, in the public docket. The docket is available for public inspection before and after the comment closing date.

Privacy Act: Using the search function of our docket Web site, anyone can find and read the comments received into any of our dockets, including the name of the individual sending the comment (or signing the comment on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78) or you may visit http://dms.dot.gov.

Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.

If you mail your comments and want the FAA to acknowledge receipt of the comments, you must include with your comments a preaddressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2006-26714.” We will date stamp the postcard and mail it to you.

Do not file in the docket information that you consider to be proprietary or confidential business information. Send or deliver this information directly to the person identified in the FOR FURTHER INFORMATION CONTACT section of this document. You must mark the information that you consider proprietary or confidential. If you send the information on a disk or CD-ROM, mark the outside of the disk or CD-ROM and also identify electronically within the disk or CD-ROM the specific information that is proprietary or confidential.

Under 14 CFR 11.35(b), when we are aware of proprietary information filed with a comment, we do not place it in the docket. We hold it in a separate file to which the public does not have access and place a note in the docket that we have received it. If we receive a request to examine or copy this information, we treat it as any other request under the Freedom of Information Act (5 U.S.C. 552). We process each request to examine or copy information marked as proprietary or confidential under the DOT procedures found in 49 CFR part 7.

You can get an electronic copy of this NPRM using the Internet by:

(1) Searching the Department of Transportation's electronic Docket Management System (DMS) Web page ( http://dms.dot.gov/search );

(2) Visiting the Office of Rulemaking's Web page at http://www.faa.gov/avr/arm/index.cfm; or

(3) Accessing the Government Printing Office's Web page at http://www.gpoaccess.gov/fr/index.html.

You can also get a copy by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW., Washington, DC 20591, or by calling (202) 267-9680. Make sure to identify the docket number, notice number, or amendment number of this rulemaking.

On March 12, 1990, the FAA published a Notice of Proposed Rulemaking (NPRM) in the Federal Register (55 FR 9270). The NPRM proposed changes to certain requirements concerning registration of aircraft, certification of pilots, and penalties for registration and certification violations. The NPRM also announced non-rulemaking procedural changes. We intended the changes to correct deficiencies in our systems and procedures identified in the FAA Drug Enforcement Assistance Act of 1988 (Pub. L. 100-690) (hereafter, “the Act”). The Act amended FAA's authorizing legislation (49 U.S.C. 40101 et seq. ) to—

• Declare that it is FAA policy to assist law enforcement agencies in the enforcement of laws that regulate controlled substances, to the extent consistent with aviation safety;

• Modify the aircraft registration system to more effectively serve the needs of buyers and sellers of aircraft, drug enforcement officials, and other users of the system;

• Modify the pilot certification system to more effectively serve the needs of pilots and drug enforcement officials;

• Modify the system for processing major repair and alterations of fuel tanks and fuel systems on aircraft, to more effectively serve users of the system, including drug enforcement officials;

• Establish and collect the fees necessary to cover the costs of issuing aircraft registration certificates, issuing airman certificates for pilots, and processing forms for major repairs and alterations of fuel tanks and fuel systems of aircraft;

• Pursue civil actions and assess civil penalties for violations of the regulations governing registering aircraft and recording aircraft title documents; and

• Create criminal penalties for forgery of airman certificates, false marking of aircraft, and other aircraft registration violations and to make it unlawful for any person to knowingly and willingly operate an aircraft in violation of any requirement for display of navigation or anti-collision lights.

The comment period closed on May 11, 1990. We received 373 comments, very few of which expressed support for the proposed changes. For the most part, commenters believed that the proposed changes would impose burdens only on law-abiding citizens, while criminals would simply circumvent them. As a result, FAA decided to delay the rulemaking process to assess whether specific technological improvements to the FAA Civil Aviation Registry (the Registry) could meet the intent of the Act. We believe we have now fulfilled most requirements of the Act through changes to systems and procedures used by the Registry. For this reason, we have withdrawn the 1990 NPRM in its entirety. Readers interested in the specific actions we have taken to fulfill the requirements of the Act should refer to the notice withdrawing the 1990 NPRM (70 FR 72403, Dec. 5, 2005).

To complete our obligations under the Act, we are proposing to address two deficiencies noted in the Act and not fully addressed through changes made to the Registry. The first issue concerns the proper identification of pilots. Law enforcement agencies must be able to establish the true identity of those who hold pilot certificates. The second issue concerns the timely reporting of aircraft sales or other transfers of ownership. Law enforcement agencies must be able to determine who is the owner of an aircraft, particularly when ownership of the aircraft has recently been transferred. Later in this preamble, we describe the specific changes we are proposing to address these issues.

The FAA has two ongoing rulemaking activities that relate to airmen certificates and aircraft registration. This NPRM would bring closure to FAA actions related to the FAA Drug Enforcement Assistance Act. The second NPRM will address requirements of the Intelligence Reform and Terrorism Prevention Act of 2004 (Pub. L. 108-458). While both cover issues concerning airmen certificates and aircraft registration, they are each driven by different requirements and circumstances.

During the process of preparing this NPRM for publication in late 2004, Congress passed the Intelligence Reform and Terrorism Prevention Act of 2004. Section 4022 (Improved Pilot Licenses) of that Act requires pilots’ certificates be resistant to tampering, alteration, and counterfeiting. The FAA began issuing plastic certificates in July 2003 that are resistant to tampering, alteration, and counterfeiting. This NPRM would establish dates by which paper certificates may not be used to exercise the privileges authorized by the certificates. This will allow the FAA to also meet the first requirement of the Intelligence Reform Act and increase the security of airman certificates in a timely manner.

The Intelligence Reform Act also requires the inclusion of a photograph on pilots’ certificates. The FAA is currently working on an NPRM that would establish the regulations and procedures necessary to implement this requirement. We expect to publish the NPRM in the near future. We have already completed a prototype for inclusion of a photograph on an airmen's certificate.

While this NPRM completes action by the FAA on the FAA Drug Enforcement Assistance Act, the FAA is continuing to evaluate other changes to improve data quality of the Registry, possibly including periodic registration of aircraft. In a post-9/11 environment, there are important benefits that would result from a more up-to-date and accurate Registry.

Under our authorizing legislation, the FAA must issue an “airman certificate” to an individual when we find that the individual is qualified for, and physically able to perform the duties related to, the position authorized by the certificate. See 49 U.S.C. 44703. Sometimes people think of a pilot certificate when the words “airmen certificate” are used, even though there are many other categories of airmen. In this preamble, we use the term “airman certificate” to refer generally to all those who hold airmen certificates, including pilots, flight crewmembers other than pilots (such as flight engineers), and airmen other than flight crewmembers (such as air traffic control tower operators and mechanics). When we use the term “pilot certificate” in this preamble, we are referring only to pilots, not to student pilots, flight instructors, flight engineers, or ground instructors who are also regulated under part 61 of Title 14 of the Code of Federal Regulations (14 CFR part 61). The airman certificate must—

• Contain the name, address, and description of the individual to whom the certificate is issued;

• Contain any necessary terms, conditions, and limitations; and

• Specify the capacity in which the holder of the certificate may serve as an airman with respect to an aircraft.

The current regulations and procedures for getting an airman certificate usually require that an applicant pass both a knowledge test and a flight or practical test. The applicant sends the application and supporting documents to an FAA designee, who in turn sends the application to an FAA Flight Standards District Office for review. Alternatively, the applicant may appear before an FAA inspector in the District Office. The District Office forwards the documents to the Registry where the documents are reviewed for compliance with the regulations. If the Registry accepts the documents, it issues the airman certificate and mails it to the applicant.

The FAA Drug Enforcement Assistance Act amended section 44703 to direct the FAA to modify the system for issuing airman certificates to pilots to make the system more effective in serving the needs of pilots and officials responsible for enforcement of laws relating to the regulation of controlled substances. The Act identified a number of deficiencies and abuses that the modifications must address, including the use of counterfeit and stolen airman certificates by pilots and the submission of unidentifiable names of individuals on applications for registration of aircraft. The Act also amended section 44703 to require the FAA to prescribe regulations to address the abuses and deficiencies.

In 2002, the FAA revised the pilot certificate requirements of part 61 to require a person to carry photo identification when exercising the privileges of the pilot certificate and to present photo identification when requested by law enforcement officials. See 67 FR 65858, October 28, 2002. These changes address security and law enforcement concerns regarding the identification of pilots. Also, in July 2003, the FAA discontinued issuing paper airman certificates and began issuing airman certificates that incorporate a number of security features. The new certificates are made of high-quality plastic card stock and include micro printing, a hologram, and an ultraviolet-sensitive layer that contains certain words and phrases. These new certificates greatly reduce the ability to create counterfeit airman certificates.

As far as airman certificates issued since July 2003 are concerned, these measures address the problem of counterfeit and stolen airman certificates. However, there is no requirement that a holder of a paper airman certificate get a new plastic certificate. So the outstanding paper certificates are all subject to a higher risk of counterfeiting for the foreseeable future. If there were a requirement for a holder of a paper certificate to periodically get a re-issued certificate, such as is the case with driver's licenses issued by most States, the problem of potential counterfeiting would gradually diminish over time. However, there is currently no reissuance requirement for most airman certificates.

For this reason, the FAA is proposing that the holder of a paper pilot certificate may not exercise the privileges of the paper certificate after two years from the date of adoption of the final rule. After the two-year period, only an FAA-issued plastic pilot certificate may be used to exercise piloting privileges. The proposal would not revoke or otherwise cancel a paper certificate. It would simply require the pilot to have the plastic certificate to exercise the attendant privileges.

We believe that two years is a reasonable time to allow for the replacement of pilot certificates by those who want to act as a pilot after the two-year period without interruption. (A person may apply for a plastic certificate after the two-year period, but he or she would not be able to exercise piloting privileges until he or she obtained the plastic certificate.) We are assuming that applications for the plastic replacement certificate would be evenly spread out through the two-year period. If all pilots waited until close to the end of the two-year period to apply for the replacement certificate, there would undoubtedly be delays in processing and receipt of the new certificate. The two-year period balances our ability to receive and process applications for replacement certificates, to maintain our existing range of services, and to reduce the risk of counterfeiting of paper certificates.

To effect this change, we are proposing to add new 14 CFR 61.19(h), titled, “Duration of pilot certificates.” Readers should note that the NPRM would not require a holder of a paper pilot certificate to surrender the certificate when getting the new plastic certificate. The paper certificate would not authorize the holder to exercise piloting privileges, but those who wish to retain it may do so. The fee for replacing an existing paper certificate would be $2.00. This nominal fee would defray part of the Registry's cost of replacing the approximately 440,000 existing paper pilot certificates. At the same time, the $2.00 fee would not be an undue burden on individuals. The NPRM would not apply to student pilot certificates or flight instructor certificates. Under existing regulations, these certificates expire 24 calendar months from the month in which they are issued or renewed. See 14 CFR 61.19(b) and (d).

We are also proposing that ground instructors, flight crewmembers other than pilots (regulated under 14 CFR part 63) and airmen other than flight crewmembers (regulated under 14 CFR part 65) who hold paper airmen certificates may not exercise the privileges of the paper certificates after five years from the effective date of the final rule. After the five-year period, only an FAA-issued plastic airmen certificate could be used to exercise these privileges. The proposal would not revoke or otherwise cancel a paper certificate. It would simply require the airman to have the plastic certificate to exercise the attendant privileges.

Although the FAA Drug Enforcement Assistance Act only addressed pilot certificates, we are proposing a parallel change for these other airmen certificates under the FAA's general rulemaking authority. Ground instructors and part 63 and part 65 airmen play an essential role in the functioning of the civil aviation system. We would be remiss if we did not also seek to address any potential problems associated with accurate identification of these airman certificate holders. A mechanic or flight engineer would have access to aircraft and have opportunities to participate in drug smuggling activities, such as concealment of drugs on the aircraft.

To effect these changes, we are proposing to revise existing 14 CFR 61.19(e) and add new 14 CFR 63.15(d) and 65.15(d). As is the case with pilot certificates, replacement of these certificates would cost the holder $2.00. To make the replacement process as quick and easy as possible, the Registry has recently set up a system that allows a certificate holder to request a replacement certificate using the Internet. Certificate holders may access this system by going to the following address: https://amsrvs.registry.faa.gov/amsrvs.

Under the FAA's authorizing legislation, a person may operate an aircraft in the United States only when the aircraft is registered under 49 U.S.C. 44103, with three exceptions. One exception allows operation of an aircraft for a reasonable period of time after transfer of ownership until the new owner completes the registration process. See 49 U.S.C. 44101(b)(3).

The current regulations for aircraft registration (14 CFR part 47) require an aircraft seller to fill in the reverse side of the aircraft registration certificate with the name and address of the buyer and return it to the Registry in Oklahoma City. To operate the newly purchased U.S. civil aircraft, the buyer must complete an application for aircraft registration and send it with evidence of ownership, such as a bill of sale, to the Registry (§ 47.31(a)). Once the Registry examines the application and supporting documents for legibility and compliance with part 47, it issues an aircraft registration certificate to the new owner. It typically takes 30 to 40 days to issue an aircraft registration certificate if there are no complications. During this review period (or for up to 90 days), the buyer may operate the aircraft under temporary authority by retaining a duplicate copy of the registration application—the so-called “pink slip.” The buyer must carry the pink slip in the aircraft as evidence of temporary authority to operate the aircraft without a certificate of registration. The buyer can take advantage of this temporary operating authority only after sending the aircraft registration package to the Registry (§ 47.31(b)). The current requirements, including the ability to operate an aircraft under temporary authority based on the pink slip, were established to provide a smooth transfer of ownership that would not unduly restrict operation of the aircraft during processing of an application for registration.

The Act authorizes the FAA to modify the system for registering and recording conveyances to make the system more effective in serving the needs of buyers and sellers of aircraft and of officials responsible for enforcement of laws relating to the regulation of controlled substances. See 49 U.S.C. 44111. The Act identified a number of deficiencies and abuses that the modifications must address, including the practice of allowing temporary operation and navigation of aircraft without issuance of a certificate of registration and submission of unidentifiable names of individuals on applications for registration of aircraft. The Act also authorized the FAA to prescribe regulations to address the abuses and deficiencies.

The FAA has taken a number of steps to address the period after sale or transfer of ownership and before application is made for registration. A document index is now available on-line at the Registry Web site ( http://registry.faa.gov ) or through an inquiry to the FAA Law Enforcement Assistance Program. The index, which is updated daily, tells whether the Registry has received documents related to a specific aircraft. The FAA Law Enforcement Assistance Program can retrieve all documents associated with an aircraft in a matter of minutes. If there is any question as to the ownership of an aircraft, the documents can be forwarded to the appropriate law enforcement organization.

If law enforcement personnel are questioning the operator of an aircraft who is using a pink slip, they can check the document index to determine if documents have been received for that aircraft. If no documents are shown in the index, then there is increased likelihood the aircraft is being operated in an unauthorized manner. Also, the entire aircraft registry database is available on-line at the Registry Web site. When an aircraft is sold, the seller must notify the Registry of the sale, and the Registry identifies the aircraft as “sale reported” until it processes the buyer's registration application. The Registry updates this information daily. Anyone can check an aircraft's registration through the Registry Web site to see if the aircraft is identified as “sale reported.” The Registry contains over 25 million pages of aircraft information in digital format.

Our current regulations at 14 CFR 47.31(a) require each applicant for aircraft registration to send the registration application to the Registry. Paragraph (b) of the same section allows the applicant to carry the pink slip in the aircraft as temporary authority to operate it after complying with paragraph (a). (Emphasis added.) To use the pink slip as temporary operating authority, the aircraft operator must have already sent the registration application to the Registry. It is not legal to operate the aircraft under a pink slip if the operator has not sent the registration application to the Registry.

In spite of current regulatory requirements and the administrative actions we have taken, as outlined above, we still have a concern about the accuracy of ownership information contained in the Registry. Those who transfer ownership of U.S.-registered aircraft may not be notifying the Registry of the transfer in a timely fashion. The effectiveness of the Registry's document index and aircraft registry database depends on the accuracy and timeliness of the information they contain. If a law enforcement agency investigating an aircraft goes to the index or the database for ownership information, and the information does not reflect a recent transfer of ownership, the investigation may be stymied or delayed. For this reason, we are proposing an amendment to 14 CFR 47.41(b) that would require the person selling, or otherwise transferring ownership of, a U.S.-registered aircraft to return the certificate of aircraft registration to the Registry within five days of sale or transfer.

We believe that five days is a reasonable amount of time to complete the reverse side of the certificate and send it to the Registry. It achieves a balance between our need to have accurate, up-to-date information in the Registry for the use of law enforcement agencies and our desire not to unduly burden individuals. We specifically request comments from the public, particularly owners of U.S.-registered aircraft, concerning whether this is a reasonable time frame.

To address the problem of the submission of illegible names of individuals on applications for registration of aircraft, we are proposing to require each applicant to provide a printed or typed name with his or her signature. The Registry has already included this requirement in the instructions for completing the aircraft registration application. We are proposing to add it to our regulations to bolster our authority to reject applications that contain illegible names. To effect this change, we are modifying a previously undesignated portion of 14 CFR 47.31 that appears between existing paragraphs (a) and (b). Currently, the FAA rejects an application if it is not completed or if the name and signature on the application are not the same throughout. Under this proposal, the currently undesignated provision would become new 14 CFR 47.31(b) and would include the requirement for a printed or typed name under the signature. Existing paragraphs (b) and (c) would be redesignated as paragraphs (c) and (d).

This proposal contains the following new information collection requirements. As required by the Paperwork Reduction Act of 1995 (44 U.S.C. § 3507(d)), the FAA has submitted the information requirements associated with this proposal to the Office of Management and Budget for its review.

Title: Drug Enforcement Assistance.

Summary: Two years after the final rule becomes effective, paper pilot certificates may no longer be used to exercise piloting privileges. Five years after the final rule becomes effective, certain other paper airmen certificates, such as those of flight engineers and mechanics, may no longer be used to exercise the privileges authorized by those certificates. To exercise the privileges after those respective dates, the airmen would have to hold upgraded, counterfeit-resistant plastic certificates.

Use: These changes are responsive to concerns raised in the FAA Drug Enforcement Assistance Act. The purpose of the changes is to upgrade the quality of data and documents to assist Federal, State, and local agencies to enforce the Nation's drug laws.

Respondents (including number of): The FAA estimates that there are 900,000 active airmen, of which 450,000 are pilots.

Frequency: This is a one-time requirement.

Annual Burden Estimate: Each airman having a paper certificate would need to provide the FAA, the Airmen Certification Branch at the Civil Aviation Registry, with the appropriate paperwork. This can be done either through the mail or electronically. The fee for this new replacement certificate is $2. The FAA assumes that it will take no more than five minutes for each airman to process the paperwork; the total cost to each airman would be about $3. Five-year costs range from $2.80 million ($2.42 million, discounted) to $4.43 million ($3.82 million, discounted).

The agency is soliciting comments to—

(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

(2) Evaluate the accuracy of the agency's estimate of the burden;

(3) Enhance the quality, utility, and clarity of the information to be collected; and

(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

Individuals and organizations may submit comments on the information collection requirement by March 6, 2007, and should direct them to the address listed in the ADDRESSES section of this document. Comments also should be submitted to the Office of Information and Regulatory Affairs, OMB, New Executive Building, Room 10202, 725 17th Street, NW., Washington, DC 20053, Attention: Desk Officer for FAA.

According to the 1995 amendments to the Paperwork Reduction Act (5 CFR 1320.8(b)(2)(vi)), an agency may not collect or sponsor the collection of information, nor may it impose an information collection requirement unless it displays a currently valid OMB control number. The OMB control number for this information collection will be published in the Federal Register , after the Office of Management and Budget approves it.

In keeping with U.S. obligations under the Convention on International Civil Aviation, FAA's policy is to comply with International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA determined that there are no ICAO Standards and Recommended Practices that correspond to these proposed regulations.

Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 directs that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (19 U.S.C. 2531-2533) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act requires agencies to consider international standards and, where appropriate, to be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation). The FAA currently uses an inflation-adjusted value of $128.1 million in lieu of $100 million.

In conducting these analyses, FAA has determined this rule: (1) Has benefits that justify its costs, is not a “significant regulatory action” as defined in section 3(f) of Executive Order 12866, but is “significant” under DOT's Regulatory Policies and Procedures; (2) will not have a significant economic impact on a substantial number of small entities; (3) will not affect international trade; and does not impose an unfunded mandate on state, local, or tribal governments, or on the private sector. These analyses, available in the docket, are summarized below.

Total estimated costs, over five years, to replace paper certificates with plastic, range from a low of $3.73 million ($3.22 million, discounted) to $5.91 million ($5.09 million, discounted). These are the estimated costs that the rule would impose on the government and the private sector by requiring replacement of paper certificates with plastic.

Reliable data is not available upon which to quantify benefits. However, this proposed rule is mandated by statute; consequently, the American people, through their elected officials, have established that the benefits justify the costs.

All airmen who currently have paper certificates that want to continue to be able to exercise those privileges.

The Civil Aviation Registry would need to process an estimated 545,900 to 863,900 certificates because of the rule.

• Discount rate—7%;

• Period of analysis—2006 through 2010;

• All monetary values are expressed in 2005 dollars;

• There are currently 900,135 paper certificates for airmen—of these, almost 450,000 are pilots, while the balance are other airmen; all but those that would normally be issued for replacement and additional ratings without the proposed rule and those that are currently held by certified flight instructors (CFI) would need to be replaced by the rule.

• By the start of 2006 the FAA estimates that the number of paper certificates would be reduced to 863,859 because pilots and airmen are currently being issued plastic certificates due to replacements and additional ratings.

• The FAA assumes that an equal number of certificates would be replaced each year. For pilots, approximately 208,700 would be replaced in each of the first two years, and for all other airmen, approximately 89,300 would be replaced each year;

• The FAA considered a low cost and high cost scenario.

• The time for an airman to fill out the Pilot Certificate Reissuance Form is five minutes. The FAA believes that the actual amount of time is probably less than this, but is using five minutes uniformly so as to be conservative and not underestimate costs;

• Airman's time is costed out at $37.76 per hour;

• An FG-10 time is costed out at $33.09 per hour; and

• An FG-6 time is costed out at $22.11 per hour.

• Not all replacements can be attributed to the rule.

• The FAA assumes that approximately 56,200 airmen certificates would be replaced each year without the rule.

• In addition, the FAA assumes that approximately 48,000 certificates would be issued annually for additional ratings on an existing certificate.

• 65% of both the replacement and new certificates issued for additional ratings are for pilots.

• Without the rule, each year approximately 36,500 pilot certificates would be replaced and approximately 31,200 pilot certificates would be issued for additional ratings. Of the approximately 208,700 pilot certificates that must be replaced, approximately 67,800 would be replaced without the rule and therefore approximately 140,900 would have to be replaced because of the rule in each of the first two years.

• 35% of both the replacement and new certificates issued for additional ratings are for other airmen.

• Without the rule, each year approximately 19,700 other airmen certificates would be replaced and approximately 16,800 other airmen certificates would be issued for additional ratings. Of the approximately 89,300 other airmen certificates that would be replaced each year, approximately 36,500 would be replaced without the rule and approximately 52,800 would have to be replaced because of the rule in each of the first five years.

• Assumes that airmen would not replace or upgrade paper certificates without the rule.

Congress has determined that, at the present time, the smuggling of drugs into the United States by general aviation aircraft is a major contributing factor in the illegal drug crisis facing the nation. As a result of that determination, the Congress expanded the mission of the FAA to include assisting law enforcement agencies in the enforcement of laws regulating controlled substances, to the extent consistent with aviation safety.

The Congress has stated in the Drug-Free America Policy of the Drug Enforcement Assistance Act of 1988 that the total cost of drug use to the economy is estimated to be over $100 billion annually. Were this rule to reduce society's economic cost of drug use by approximately 1/85,000th for the high cost scenario or 1/134,000th for the low cost scenario over five years, that achievement would approximately equal the estimated cost to society of these regulatory changes. The FAA believes that such a reduction is achievable. Congress, which reflects the will of the American public, has determined that this proposed action is in the best interest of the nation.

The FAA assumes that an equal number of paper airmen certificates will be replaced each year. The FAA projects that there will be about 417,300 pilots who will still hold paper certificates at the start of 2006, so the FAA assumes that about 208,700 would get their new plastic certificate in 2006 and in 2007. Excluding the CFI's, about 446,500 other individuals with airman certificates would need to replace their certificates over a 5 year period, or about 89,300 a year.

The FAA has considered two cost scenarios. The first low cost scenario assumes that, since some airmen have been replacing their paper certificates with the new plastic certificates either because they have requested replacement certificates or because they have received new certificates after attaining additional ratings, they would continue to do so without the rule. The cost that these pilots would incur to replace their certificates cannot be considered a cost of the proposed rule, since they would replace their certificates without the rule. The second high cost scenario assumes that no pilots or airmen would replace their paper certificates with plastic certificates unless the rule required them to do so.

In this scenario, we assume that without the rule, approximately 36,500 pilots and about 19,700 other airmen would replace their certificates annually. Further, some airmen acquire a new certificate because they earn additional ratings. We estimate that approximately 31,200 pilots and about 16,800 other airmen would earn additional ratings annually and be issued a new plastic certificate to reflect these additional ratings. Since this would occur regardless of the proposed rule, the cost to replace these certificates would not be considered a cost of the rule.

To summarize, approximately 67,800 pilots would acquire plastic certificates annually regardless of the proposed rule. In each of the first two years, approximately 140,900 pilots would have to replace their certificates because of the proposed rule (208,700 minus 68,000). In addition, approximately 36,500 other airmen would acquire plastic certificates annually regardless of the proposed rule. In each of the first five years, approximately 52,800 other airmen would have to replace their certificates because of the proposed rule (89,300 minus 36,500). This scenario may underestimate costs because it assumes that replacements and upgrades that would occur regardless of the proposed rule would always replace paper certificates. However, once paper certificates become replaced with plastic, some of the later replacements/upgrades not related to the rule, would involve replacement/upgrades of plastic certificates.

In this scenario the FAA assumes that there would be no replacements or upgrades without the rule and that the cost of the proposed rule would be the cost to replace all paper certificates that exist as of the start of 2006 (which is when we assume the rule will take effect). Therefore, the FAA assumes that in each of the first two years, approximately 208,700 pilots would have to replace their paper certificates with plastic, and that these costs are attributed completely to the proposed rule. The FAA also assumes that in each of the first five years, approximately 89,300 other airmen would have to replace their paper certificates with plastic because of the proposed rule. This is an extremely conservative scenario, which overestimates cost.

There are two sets of costs associated with replacing the current paper certificates, one for airmen and one for the Government.

Each airman having a paper certificate would need to provide the FAA, the Airmen Certification Branch at the Civil Aviation Registry with the appropriate paperwork. This can be done either through the mail or electronically. The fee for this new replacement certificate is $2. The FAA assumes that it will take no more than five minutes for each airman to process the paperwork; the total cost to each airman would be about $3. Five-year costs range from $2.87 million ($2.47 million, discounted) to $4.54 million ($3.90 million, discounted). The lower cost represents the low cost scenario; the higher cost represents the high cost scenario.

There are several steps involved with the FAA processing a request for a duplicate airman certificate. These steps include different grade levels and/or contract costs and includes Legal Instruments Examiners as well as contractors who would preprocess and scan the images, index the image, review the certificate for accuracy, and print and mail the certificates. The total costs per new certificate sum to $3.59. However, airmen would pay $2 for the certificate and therefore the net cost to the government would be $1.59 per certificate; five-year costs range from $867,900 ($749,300, discounted) to $1.37 million ($1.18 million discounted). The lower cost represents the low cost scenario; the higher cost represents the high cost scenario.

Total costs, over five years, to replace the existing paper certificates range from $3.73 million ($3.22 million, discounted) to $5.91 million ($5.09 million, discounted). The lower cost represents the low cost scenario; the higher cost represents the high cost scenario.

The Regulatory Flexibility Act of 1980 (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the business, organizations, and governmental jurisdictions subject to regulation.” To achieve that principle, the RFA requires agencies to solicit and consider flexible regulatory proposals and to explain the rationale for their actions. The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations and small governmental jurisdictions.

Agencies must perform a review to determine whether a proposed or final rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the Act.

However, if an agency determines that a proposed or final rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the 1980 RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.

This rule affects aircraft owners, through part 47, and pilots, through parts 61, 63, and 65.

The change to part 47 would affect all aircraft owners. However, as stated above, they have always been required to send in the registration package upon purchase of a new aircraft; this proposal does not impose any new requirements on new aircraft owners. Accordingly, there are no additional costs for these owners.

The changes to parts 61, 63, and 65 would impose an estimated $5 in compliance costs on pilots applying for certificate reissuances. This cost covers the costs for the postage, applicant's time, and the $2 reissuance fee charged to pilots. However, pilots are not small entities and are not covered by the Regulatory Flexibility Act. The FAA recognizes that there are one-man businesses that provide aviation services; however, the cost of this proposed rule to them would be negligible and, therefore, not significant.

Thus, the FAA certifies that this proposal would not have a significant economic impact on a substantial number of small entities.

The Trade Agreement Act of 1979 prohibits Federal agencies from establishing any standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as safety, are not considered unnecessary obstacles. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this NPRM and has determined that it would have only a domestic impact and therefore no affect on any trade-sensitive activity.

The Unfunded Mandates Reform Act of 1995 (the Act) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in an expenditure of $100 million or more (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $128.1 million in lieu of $100 million.

This proposed rule does not contain such a mandate. The requirements of Title II do not apply.

The FAA has analyzed this NPRM under the principles and criteria of Executive Order 13132, Federalism. We determined that this action will not have a substantial direct effect on the States, or the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, we determined that this NPRM does not have federalism implications.

Executive Order 12866 (58 FR 51735, Oct. 4, 1993) requires each agency to write regulations that are simple and easy to understand. We invite your comments on how to make these regulations easier to understand, including answers to questions such as the following:

• Are the requirements in the regulations clearly stated?

• Do the regulations contain technical language or jargon that interferes with their clarity?

• Would the regulations be easier to understand if they were divided into more (but shorter) sections?

• Is the description in the preamble helpful in understanding the regulations?

Please send your comments to the address specified in the ADDRESSES section.

FAA Order 1050.1E identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this proposed rulemaking action qualifies for the categorical exclusion identified in paragraph 312d and involves no extraordinary circumstances.

The FAA has analyzed this NPRM under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 18, 2001). We have determined that it is not a “significant energy action” under the executive order because it is not a “significant regulatory action” under Executive Order 12866, and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

In consideration of the foregoing the Federal Aviation Administration proposes to amend Chapter I of Title 14 Code of Federal Regulations as follows:

The Nutrition Labeling and Education Act of 1990 (NLEA) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. The NLEA clarified FDA's authority to regulate health claims on food labels and in food labeling by amending the act to add section 403(r) to the act (21 U.S.C. 343(r)). Section 403(r) specifies, in part, that a food is misbranded if it bears a claim that expressly or by implication characterizes the relationship of a nutrient to a disease or health-related condition unless the claim is made in accordance with section 403(r)(3) (for conventional foods) or 403(r)(5)(D) (for dietary supplements).

The NLEA directed FDA to issue regulations authorizing health claims (i.e., labeling claims that characterize the relationship of a substance to a disease or health-related condition) for conventional foods only if the agency determines, based upon the totality of publicly available scientific evidence (including evidence from well-designed studies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement (SSA), among experts qualified by scientific training and experience to evaluate such claims, that the claim is supported by such evidence (21 U.S.C. 343(r)(3)(B)(i)). Congress delegated to FDA the authority to establish the procedure and standard for health claims for dietary supplements (21 U.S.C. 343(r)(5)(D)).

FDA issued regulations establishing general requirements for health claims in labeling for conventional foods (58 FR 2478; January 6, 1993). By regulation (59 FR 395; January 4, 1994), and under Congressional authority, 1 FDA adopted the same general requirements, including the procedure and standard, for health claims in dietary supplement labeling that Congress had prescribed in the NLEA for health claims in the labeling of conventional foods. (See 21 U.S.C. 343(r)(3) and (r)(4)).

The regulations require the evidence supporting a health claim to be presented to FDA for review before the claim may appear in labeling (§§ 101.14(d) and (e) and 101.70 (21 CFR 101.14(d) and (e) and 21 CFR 101.70)). The standard requires a finding of “significant scientific agreement” (SSA) before FDA may authorize a health claim by regulation (§ 101.14(c)).

Among its provisions regulating claims, the NLEA required FDA to determine whether claims respecting 10 specific substance/disease relationships met the requirements for a health claim (NLEA section 3(b)(1)(A)(vi) and (x), Public Law 101-535). The relationship between calcium and a reduced risk of osteoporosis was one of those 10 nutrient/disease relationships. On March 28, 1991, FDA published a notice in the Federal Register requesting scientific data and information on the 10 specific topic areas identified (56 FR 12932). Scientific studies and data received in response to the notice, that were relevant to the agency's review, were considered as part of the agency's review of the scientific literature on calcium and osteoporosis and were included in the proposed rule for the calcium and osteoporosis health claim for use on foods, including dietary supplements (56 FR 60689; November 27, 1991) (the 1991 proposed rule). Before publication of the calcium and osteoporosis final rule (58 FR 2665; January 6, 1993), the agency reviewed any scientific research and review articles relevant to calcium intake and osteoporosis that became available after publication of the proposed rule and concluded that the new studies were consistent with the tentative conclusions drawn in the 1991 proposed rule (58 FR 2665 at 2672). Thus, in the calcium and osteoporosis final rule FDA concluded that, based on the totality of the publicly available scientific evidence, there was significant scientific agreement among qualified experts that a health claim for calcium and a reduced risk of osteoporosis was supported by the evidence (id.) (Codified in § 101.72 (21 CFR 101.72)).

In December of 1995, in response to citizen petitions submitted by the National Food Processors Association (Docket No. 1994P-0390) and the American Bakers Association (Docket No. 1995P-0241), FDA proposed to amend its regulations on health claims and nutrient content claims to provide more flexibility in the use of these claims on food products (60 FR 66206; December 21, 1995) (the 1995 proposal). This document discussed many proposed amendments to FDA regulations intended to benefit public health by encouraging manufacturers to use health claims and nutrient content claims to assist consumers in maintaining healthy dietary practices. In the 1995 proposal, FDA proposed, among other things, certain amendments to simplify the current required claim language for the calcium and osteoporosis health claim in § 101.72.

In response to requests by stakeholders and other FDA initiatives and developments, the agency reopened the comment period for the 1995 proposal several times. The most recent reopening of the comment period was announced in the Federal Register on May 4, 2004 (69 FR 24541), and the comment period was open until July 6, 2004. Because many of the amendments in the 1995 proposal are similar to or exactly the same as those requested by The Beverage Institute for Health and Wellness in their health claim petition, and that FDA is proposing herein, the agency considered the comments submitted in response to the 1995 proposal in the development of this proposed rule. Comments on other aspects of the 1995 proposal are not considered in this proposed rule. Elsewhere in this issue of the Federal Register , the agency is withdrawing the part of the 1995 proposed rule related to the calcium and osteoporosis claim language.

On July 12, 2004, the agency received a health claim petition submitted by The Beverage Institute for Health and Wellness (the petitioner) under section 403(r)(4) of the act. 2 The petitioner noted that the agency already has an authorized health claim (§ 101.72) on the ability of calcium to reduce the risk of osteoporosis among teen and young adult white and Asian women who engage in regular physical activity, and stated that they believed that there was now significant scientific agreement to support authorization of an expanded osteoporosis health claim that includes vitamin D and eliminates the restrictive language regarding age, race, gender, and physical activity. The petitioner also noted that FDA had already proposed most of the petitioner's proposed amendments in the 1995 proposal (60 FR 66206).

Specifically, the petitioner's proposed amendments to § 101.72 would: (1) Include vitamin D so that, in addition to claims for calcium and osteoporosis, additional claims can be made for calcium and vitamin D and osteoporosis; (2) eliminate the required claim language in § 101.72(c)(2)(i)(A) regarding race, age, gender, and the need for physical activity; (3) eliminate the requirement in § 101.72(c)(2)(i)(B) that the claim identify the population at particular risk for osteoporosis; (4) eliminate the requirement in § 101.72(c)(2)(i)(C) that the claim identify the mechanism by which calcium reduces the risk of osteoporosis and instead make this information optional; (5) simplify the language used in the claim; and (6) increase the amount of calcium present in the food (from 400 milligrams (mg) of calcium per reference amount customarily consumed or per daily recommended supplement intake to more than 1,500 mg calcium per day) before the claim must include a statement that reflects the limit on the benefit derived from dietary calcium intake. The petitioner concluded that amending the osteoporosis and calcium health claim in the above manner would provide the availability of a simplified, understandable health claim that would allow food manufacturers to help address the public health issue of osteoporosis by educating consumers about the importance of both vitamin D and calcium in reducing the risk of osteoporosis in later life (Ref. 1). Finally, the petitioner requested that the agency exercise its authority under section 403(r)(7) of the act to make any proposed regulation based on their petition effective upon publication, pending consideration of public comment and publication of a final rule.

On October 20, 2004, we notified the petitioner that we had completed our initial review of the petition and that the petition had been filed for further action (Docket No. 2004P-0464, Let 1) in accordance with section 403(r)(4) of the act. The October 20, 2004, letter stated that if the agency did not act, by either denying the petition or issuing a proposed regulation to authorize the health claim, within 90 days of the date of filing, the petition would be deemed to be denied unless an extension was mutually agreed upon by the agency and the petitioner (section 403(r)(4)(A)(i) of the act and § 101.70(j)(3)(iii)). FDA and the petitioner agreed to extend the publication date of a regulation until January 18, 2007 (Docket No. 2004P-0464, Let 6).

The petition requested, among other things, that FDA amend the calcium and osteoporosis health claim (§ 101.72) to include vitamin D so that, in addition to claims for calcium and osteoporosis, claims can be made for calcium and vitamin D and osteoporosis. Thus, FDA considered two substances that are the subject of the petition: (1) Calcium and (2) calcium and vitamin D. Unless specified, the term ‘vitamin’ D means D 2 (ergocalciferol), D 3 (cholecalciferol) or a combination of vitamin D 2 and D 3 .

Osteoporosis, which is defined as a skeletal disorder characterized by compromised bone strength, continues to be a major public health problem in the United States, even after authorization of the calcium and osteoporosis health claim in 1993. The continued public health problem is reflected, in part, by the observation that the number of bone fractures in the United States has increased as well as the direct medical costs required to treat osteoporosis (Ref. 2). The petitioner stated that in 2002 the National Osteoporosis Foundation estimated that approximately 44 million men and women in the United States had low bone density or osteoporosis and that this value was projected to increase to more than 61 million by 2020 (Ref. 3). White and Asian women are the most susceptible to chronic bone disease, but the petitioner noted that the condition was also prevalent among African Americans (Ref. 3). Five percent of the African American U.S. population (more than 13 million people) are currently thought to have osteoporosis compared to 20 percent for White and Asian women (Ref. 3). The incidence of low bone mineral density in 2002 for African Americans and White and Asian women was estimated to be 35 and 52 percent, respectively (Ref. 3). The direct care expenditures resulting from osteoporosis range from 12.2 to 17.9 billion dollars each year measured in 2002 dollars (Ref. 4).

FDA agrees with the petitioner that, as required in § 101.14(b)(1), osteoporosis is a disease for which the U.S. population is at risk.

A health claim characterizes the relationship between a substance and a disease or a health-related condition (§ 101.14(a)(1)). A substance means a specific food or a component of food, regardless of whether the food is in conventional food form or a dietary supplement (§ 101.14(a)(2)). The petition identified calcium and vitamin D as a new substance for consideration in the calcium and osteoporosis health claim. Calcium, one of the essential nutrients for humans, is a component of milk and milk products (approximately 300 mg per serving), as well as other food sources (e.g., Chinese cabbage, kale, and broccoli) (Ref. 5). Vitamin D is naturally present in a small number of foods, such as some fish liver oils, the flesh of fatty fish, the liver and fat from aquatic mammals such as polar bears and seals, and eggs from hens that have been fed vitamin D (Ref. 6). Therefore, the agency concludes that calcium and vitamin D, are components of food and meet the definition of a substance in the health claim regulation.

Health claim general requirements provide that where a substance is to be consumed at “other than decreased dietary levels” the substance must contribute taste, aroma, or nutritive value, or any other technical effect listed in 21 CFR 170.3(o), and must retain that attribute when consumed at levels necessary to justify the claim (§ 101.14(b)(3)(i)). Nutritive value as defined in § 101.14(a)(3) means a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy. Calcium and vitamin D are essential nutrients and thus provide nutritive value to the diet (Refs. 5 and 6) and retain that attribute when consumed at levels necessary to justify the claim. Therefore, FDA concludes that the requirement of § 101.14(b)(3)(i) is satisfied.

Under § 101.14(b)(3)(ii), if the substance is to be consumed at other than decreased dietary levels, the substance must be a food or a food ingredient whose use at levels necessary to justify a claim has been demonstrated by the proponent of the claim, to FDA's satisfaction, to be safe and lawful under the applicable food safety provisions of the act.

FDA evaluates whether the substance is “safe and lawful” under the applicable food safety provisions of the act. For conventional foods, this evaluation involves considering whether the ingredient that is the source of the substance is generally recognized as safe (GRAS), approved as a food additive, or authorized by a prior sanction issued by FDA. (See § 101.70(f).)

Dietary ingredients in dietary supplements are not subject to the food additive provisions of the act (see section 201(s)(6) of the act (21 U.S.C. 321(s)(6)). Rather, they are subject to the adulteration provisions in section 402 of the act (21 U.S.C. 342) and, if applicable, the new dietary ingredient provisions in section 413 of the act (21 U.S.C. 350b), which pertain to dietary ingredients that were not marketed in the United States before October 15, 1994. The term “dietary supplement” is defined in section 201(ff)(1) of the act and includes vitamins; minerals; herbs and other botanicals; dietary substances for use by man to supplement the diet by increasing total daily intake; and concentrates, metabolites, constituents, extracts, and combinations of the preceding types of ingredients.

For dietary supplements, the applicable safety provisions require, among other things, that the dietary ingredient not present a significant or unreasonable risk of illness or injury under conditions of use recommended or suggested in labeling or, if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use (section 402(f)(1)(A) of the act). Further, a dietary supplement must not contain a poisonous or deleterious substance which may render the supplement injurious to health under the conditions of use recommended or suggested in the labeling (section 402(f)(1)(D) of the act).

The use of a health claim for calcium, or calcium and vitamin D, and osteoporosis is being evaluated for use on the labels and in the labeling of both conventional foods and dietary supplements. Thus, the agency is evaluating the safety and lawfulness of both calcium and vitamin D under the relevant provisions of the act for both conventional foods and for dietary supplements.

The petitioner asserts that vitamin D 2 (ergocalciferol) and vitamin D 3 (cholecalciferol) have been affirmed as GRAS when used as a source of this nutrient for breakfast cereals, grain products and pastas, milk, and milk products according to § 184.1950(c)(1) (21 CFR 184.1950(c)(1)). Vitamin D may also be added to infant formula in accordance with section 412(a)(2) of the act (21 U.S.C. 350a(a)(2)), and as an optional ingredient in margarine according to § 166.110 (21 CFR 166.110). The petitioner also asserts that FDA recently approved vitamin D 3 as a food additive that may be added in amounts up to 100 International Units (IU) per serving to 100 percent fruit juices (excluding those specifically formulated for infants) that are fortified with greater than 33 percent of the Reference Daily Intake (RDI) of calcium per reference amount customarily consumed (RACC) and to fruit drinks (excluding those specifically formulated for infants) that are fortified with greater than 10 percent of the RDI of calcium per RACC (68 FR 9000; February 27, 2003). As part of that rulemaking, FDA determined that persons 1 year of age or older would not be exposed to amounts of vitamin D greater than the Tolerable Upper Intake Levels (UL) after fortification of eligible juice products (68 FR 9000 at 9002). However, the agency did not allow vitamin D fortification of juice products specifically formulated for infants (id.). Thus, FDA concluded that the addition of vitamin D 3 to calcium-fortified fruit juices and juice drinks, excluding fruit juices and juice drinks specifically formulated or processed for infants, at levels not to exceed 100 IU per RACC is safe (68 FR 9000 at 9002).

FDA acknowledges that vitamin D 2 and vitamin D 3 have been affirmed as GRAS when used in breakfast cereals, grain products, pastas, milk and milk products at the intended levels (§ 184.1950) and that vitamin D 3 has been approved as a food additive to calcium-fortified 100 percent fruit juice and fruit drinks not intended for infants ((§ 172.380) (21 CFR 172.380)). FDA also acknowledges that vitamin D may be added to infant formulas in accordance with section 412(a)(2) of the act and to margarine as an optional ingredient (§ 166.110). Thus, the agency is satisfied that the petitioner has demonstrated that vitamin D may be lawfully used in conventional foods for the specific uses cited.

UL, as defined by the Institute of Medicine (IOM), are the highest levels of daily nutrient intake that are likely to pose no risks of adverse effects to almost all individuals in the general population (Ref. 7). The IOM has established a UL for vitamin D by life stage, gender, and age (Ref. 6). The IOM concluded that the most biologically important possible adverse effect of excessive vitamin D is hypercalcemia (i.e., an abnormally high concentration of calcium compounds in the circulating blood) due to hypervitaminosis D. Hypervitaminosis D is a condition resulting from the ingestion of an excessive amount of the fat-soluble vitamin D. Using hypercalcemia as the clinically defined endpoint, the IOM identified a no-observed-adverse-effect level (NOAEL) at 2,400 IU per day for adults. The IOM established 2,000 IU of vitamin D as the UL for individuals older than 18 years by dividing the NOAEL by an uncertainty factor of 1.2 to be conservative to account for uncertainties in the data set. The UL for individuals 1 through 18 years and pregnant and lactating women is specified as 2,000 IU per day (Ref. 6).

The most recent nationally representative data, 1988-1994 National Health and Nutrition Examination Survey (NHANES), found that the median intake vitamin D intake from foods, excluding dietary supplements, to be 164 IU/day for all individuals aged 2 months and older, excluding nursing infants (Ref. 8). Vitamin D can be obtained from dietary supplement sources as well as other food sources. Results from the NHANES 1988-1994 survey indicate that approximately 40 percent of the U.S. population, ages 2 months or older take dietary supplements and that the most frequent amount of vitamin D taken as a dietary supplement is 400 IU/day (Ref. 9).

Supplemental vitamin D can be obtained from multiple vitamin and mineral products, products where calcium and vitamin D are the only ingredients, or products where vitamin D is the sole ingredient (Ref. 9). Supplemental vitamin D can also be obtained from fish liver oils, such as cod liver oil (Ref. 10). Multiple vitamin and mineral supplement products generally contain 200 or 400 IU of vitamin D per RACC and recommend consumption of 1 serving per day. The RACC for dietary supplements is the maximum amount recommended as appropriate on the label for consumption per eating occasion, or in the absence of recommendations, one unit (i.e., one tablet, one capsule, one packet, one teaspoon etc. (see § 101.12(b) (21 CFR 101.12(b)) Table 2.—Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply 1, 2, 3, 4 (Table 2)). Calcium and vitamin D only products generally contain between 100 to 600 IU of vitamin D per RACC (Ref. 11). Calcium and vitamin D only products with a RACC of less than 400 IU of vitamin D recommend consumption of one to three servings per day and the recommended vitamin D intake does not exceed 600 IU per day. Calcium and vitamin D only products with an RACC of 400 IU of vitamin D or more recommend consumption of 1 serving per day and the recommended vitamin D intake does not exceed 1,000 IU per day (id.). Supplements that contain only vitamin D generally contain 400 to 1,000 IU per RACC, and recommend consumption of 1 serving per day (id). Cod liver oil products contain between 100 to 540 IU of vitamin D per RACC and the recommended vitamin D intake does not exceed 1,000 IU per day in these products (id.). Thus, the range of vitamin D intake from the various types of dietary supplement products generally varies from 100 to 1,000 IU/day. Only 7 percent of the products surveyed recommend consumption of 1,000 IU of vitamin D per day (id).

FDA has also considered the intake of vitamin D from food and dietary supplements among consumers of fruit juices and juice drinks, as part of its rulemaking in response to a food additive petition for vitamin D 3 (68 FR 9000). Relying on data submitted by the petitioner for consumers of fruit juices and juice drinks 2 years of age and older, it was estimated that the average and 90th percentile dietary intakes from currently regulated uses in conventional foods (including naturally occurring sources) and proposed food uses of vitamin D, were 306 IU per person per day (IU/p/d) and 519 IU/p/d, respectively (68 FR 9000 at 9001). Taking into account that the most frequent level of vitamin D taken as a dietary supplement is 400 IU/day, FDA estimated the mean and 90th percentile dietary intakes for consumers of fruit juices and juice drinks 2 years of age and older from current and proposed food uses and dietary supplement uses were 706 IU/p/d and 919 IU/p/d, respectively (id.). Thus, the mean and 90th percentile vitamin D intake for this population of consumers is also well below the UL of 2,000 IU/day.

The petitioner is proposing that for a food to be eligible for the additional calcium and vitamin D and osteoporosis health claim that the food meet or exceed the requirements for a “high” level of calcium and a “high” level for vitamin D, as “high” is defined in § 101.54 (21 CFR 101.54), as the levels necessary to justify the health claim. For a food to be labelled as “high” in vitamin D, it must contain 20 percent or more of the RDI per RACC for the specified nutrient. The RDI for vitamin D is 400 IU. Twenty percent of the RDI for vitamin D per day is 80 IU.

FDA notes that certain prepared foods are subject to food additive regulations that limit the amount of vitamin D that can be added to such foods. As noted previously, § 184.1950 allows the addition of vitamin D to breakfast cereals (350 IU/100 g), grain products and pastas (90 IU/100 g), milk (42 IU/100g) and milk products (89 IU/100 g). In addition, § 166.110 permits fortification of margarine (330 IU/100 g) and the newly issued § 172.380 permits the addition of vitamin D 3 to calcium-fortified 100 percent fruit juice and fruit drinks not intended for infants (100 IU/serving). Of these foods, those that are “high” in calcium (i.e., milk, certain milk products, fortified breakfast cereals and juices) are permitted to add enough vitamin D to be “high” in vitamin D to qualify for the additional claim. Foods that are not “high” in calcium (e.g., margarine, enriched grain products and pastas) would not be permitted to bear the calcium only claim. Likewise, these foods would not be permitted to bear the calcium and vitamin D and osteoporosis claim because both calcium and vitamin D must each be present at “high” levels to be eligible to bear the claim.

The amounts of vitamin D that are allowed in flavored milk and milk drinks (89 IU/100 g) and certain fruit juices and drinks (100 IU/serving) are similar to the amount that is needed to be eligible for the calcium and vitamin D and osteoporosis health claim (at least 80 IU per RACC). The amounts of vitamin D in certain fortified cereals (350 IU/ 100 g) would provide a higher amount of vitamin D. For example, a serving of a ready-to-eat biscuit-type breakfast cereal with a RACC of 55 g (see Table 2 in § 101.12(b)) with the maximum amount of vitamin D added would contain 192 IU of vitamin D/RACC.

The agency usually assumes that food consumption patterns generally reflect 3 meals a day and a snack, with about 25 percent daily intake for each (58 FR 2303 at 2379; January 6, 1993). Using this approach, considering 4 servings a day from either the lowest (42 IU) or the highest (350 IU) vitamin D containing categories that could be eligible for a vitamin D and calcium and osteoporosis health claim, one could consume from approximately 170 to 1,400 IU of vitamin D. Thus, consumers who choose foods that bear the calcium and vitamin D and osteoporosis health claim would be able to incorporate such foods into the diet in a manner that would likely keep their total intake of vitamin D well below the UL of 2,000 IU per day. For example, a serving of a biscuit-type cereal with the maximum amount of vitamin D added (192 IU) prepared with 1/2 cup of skim milk, which also has the maximum amount of vitamin D added (51 IU), for breakfast would provide 243 IU of vitamin D. A glass of orange juice with the maximum amount of vitamin D added for lunch and as an afternoon snack would provide 200 IU of vitamin D. At dinner a serving of low-fat yogurt, to which vitamin D has been added as an optional ingredient, would provide 92 IU of vitamin D. The total vitamin D intake from these foods would provide 535 IU of vitamin D in a day. Furthermore, FDA believes it reasonable to consider that consumers who supplement their diets with vitamin D would likely be consuming the most frequent level of vitamin D containing supplements (400 IU) per day. Thus, consumers who choose foods that bear the calcium and vitamin D and osteoporosis health claim and that consume a vitamin D supplement would likely keep their total intake of vitamin D below the UL of 2,000 IU/day. The agency believes it is unlikely that consumers would be consuming total amounts of vitamin D, from both conventional foods and dietary supplements that can bear the claim, at levels that would pose a safety concern.

Therefore, FDA tentatively concludes, that the use of vitamin D in conventional foods, at levels necessary to justify the claim, as described in section IV.A.2 of this document, and in accordance with the GRAS affirmation (§ 184.1950) or the food additive regulation (§ 172.380), is safe and lawful under the applicable food safety provisions of the act. Further, FDA tentatively concludes that use of vitamin D as a dietary ingredient or dietary supplement, at levels necessary to justify the claim, as described in section IV.A.2 of this document is safe and lawful under the applicable food safety provisions of the act. Thus, FDA tentatively concludes that the preliminary requirements in 21 CFR 101.14(b)(3)(ii) are satisfied.

The petitioner stated the preliminary requirements for a health claim for calcium and osteoporosis, including the requirement that the substance is safe and lawful at the level necessary to justify a claim, have already been established, as evidenced by the currently authorized claim. In the 1993 calcium and osteoporosis health claim final rule, FDA concluded that calcium's use at the levels necessary to justify the claim was safe and lawful under the applicable food safety provisions of the act (58 FR 2665 at 2670). At the time the calcium and osteoporosis health claim was authorized, in order for a food or dietary supplement to carry the claim, it had to meet or exceed the requirements for a “high” level of calcium as defined in § 101.54(c). A “high” level of calcium is at least 20 percent of the RDI of calcium per RACC. The RDI for calcium is 1,000 mg/day. Twenty percent of the RDI for calcium (200 mg) is well below the UL of 2,500 mg for calcium.

In the final rule for the authorized health claim about calcium and osteoporosis (21 CFR 101.72) (58 FR 2665 at 2670), FDA identified 10 specific calcium compounds that are deemed to be safe and lawful for use in a dietary supplement or as a nutrient supplement (i.e., added to food) that may bear the calcium and osteoporosis health claim. The 10 compounds (calcium carbonate, calcium citrate, calcium glycerophosphate, calcium oxide, calcium pantothenate, calcium phosphate, calcium pyrophosphate, calcium chloride, calcium lactate, and calcium sulfate) are either approved as food additives (21 CFR part 172), GRAS substances (21 CFR part 182), or affirmed as GRAS substances (21 CFR part 184).

At the time FDA published the final rule authorizing the health claim about calcium and osteoporosis (January 6, 1993), ingredients used in dietary supplements were subject to the premarket safety evaluations required for new food ingredients and for new uses of food ingredients. That is, such ingredients were required to be approved as food additives, determined as GRAS substances, or affirmed as GRAS substances before they could be used in food, including dietary supplements. With passage of the Dietary Supplement Health and Education Act in 1994 (DSHEA) (Public Law 103-417), Congress amended the act to provide that ingredients for dietary supplements are exempt from premarket safety evaluations for food additives or GRAS substances. Instead, Congress provided that dietary ingredients are subject to the adulteration provisions in section 402 of the act (excluding the food additive adulteration provision), and, if applicable, the new dietary ingredient provisions in section 413 of the act, which pertain to dietary ingredients that were not marketed in the United States before October 15, 1994. Therefore, the uses of these sources of calcium are subject to review under different provisions of the act, depending upon their use in or as a conventional food, or alternatively, as a dietary ingredient or dietary supplement. Since authorization of the calcium and osteoporosis health claim, no other calcium compound, other than the 10 discussed previously, has been demonstrated to FDA's satisfaction to be safe and lawful for use in a dietary supplement or as a nutrient supplement in conventional food.

Subsequent to the publication of the final rule authorizing the calcium and osteoporosis health claim, the IOM established a UL for calcium based on life stages, gender, and age in 1997 (Ref. 5). Although calcium is known to be an essential nutrient, it can also cause adverse effects. The IOM noted that the adverse effects of excess calcium intake in humans concern calcium intake from “nutrient supplements” i.e., calcium taken as a dietary supplement, and that the most widely studied and biologically important possible adverse effects of excessive calcium intake are kidney stone formation, the syndrome of hypercalcemia and renal insufficiency (milk alkali syndrome), and the interaction of calcium with the absorption of other essential minerals (Ref. 5). Using milk alkali syndrome as the clinically defined critical endpoint, the IOM identified the lowest-observed-adverse-effect level (LOAEL) of calcium intake in the range of 4,000 to 5,000 mg/day. The IOM established 2,500 mg/day of calcium as the UL for individuals over 12 months old by dividing a LOAEL of 5,000 mg/day by an uncertainty factor of 2 to take into account the relatively high prevalence of renal stones in the U.S. population, which is 12 percent, and potential increased risk of hypercalciuria and depletion of other minerals among susceptible individuals.

The most recent nationally representative data, 1999-2000 NHANES, found the median calcium intake from foods, excluding dietary supplements, to be 735 mg/day for all individuals, excluding nursing infants and children (Ref. 12). Calcium can be obtained from dietary supplement sources as well as food sources.

Calcium is often contained in multiple vitamin and mineral supplement products. Most of these products contain about 100 to 200 mg of calcium per RACC and recommended consumption of the dietary supplement once per day (Ref. 11). Some of these products contain 250 to 500 mg calcium with a recommendation of once per day, and 1 product surveyed contained up to 1,000 mg calcium with a recommended serving of once per day (id.). Calcium is also often contained in products where calcium is the sole ingredient or where calcium and vitamin D are the only ingredients. These types of products generally contain between 500 to 1,000 mg of calcium per RACC (id.). Calcium and vitamin D only products with a RACC of 500 mg of calcium recommend consumption of 1 to 3 servings per day and the recommended calcium intake does not exceed 1,500 mg per day (id.). Calcium and vitamin D only products with a RACC of 600 mg of calcium recommend consumption of 1 or 2 servings per day (id.). Products with a RACC greater than 600 mg of calcium recommend consumption of only 1 serving per day (id.). The daily intake level of calcium suggested in calcium and vitamin D only products is between 300 to 1,500 mg/day. Thus, the range of calcium intake from the various types of calcium containing dietary supplement products generally varies from 100 to 1,500 mg calcium per day, which when added to the median level of calcium intake from food (735 mg/day) is 835 to 2,235 mg calcium. This range includes amounts that are below the UL of 2,500 mg/day for calcium.

FDA also considered the amount of calcium that may be added to food in order for foods to be eligible to bear the claim. Foods that are eligible to bear the calcium or the vitamin D and calcium and osteoporosis health claim must contain at least 200 mg calcium per RACC. To estimate the daily intake of calcium from foods, the agency assumed the same food consumption patterns as considered for vitamin D, since the foods that provide enough calcium to be eligible for the claim or the proposed additional claim, also contain vitamin D. Thus, four servings of foods eligible to bear the health claim would provide at least 800 mg calcium. Such an amount is well below the UL of 2,500 mg calcium. Thus, consumers who choose foods that bear the calcium, or the calcium and vitamin D, and osteoporosis health claim would be able to incorporate such foods into the diet in a manner that would likely keep their total intake of calcium well below the UL of 2,500 mg per day. Furthermore, consumers who choose conventional foods that bear the calcium or the additional calcium and vitamin D claim and that consume up to 1,500 mg of calcium per day from supplements would also likely keep their total intake of calcium below the UL of 2,500 mg per day.

Therefore, FDA tentatively concludes, under the preliminary requirements of § 101.14(b)(3)(ii), that the use of calcium in foods, including dietary supplements, at levels necessary to justify the health claim (20 percent or more of the RDI for calcium) is safe and lawful under the applicable provisions of the act.

FDA authorized the calcium and osteoporosis health claim in response to NLEA, after conducting a review of the scientific literature on calcium and osteoporosis. The current petitioner is requesting, among other things, that the existing health claim for calcium and osteoporosis (§ 101.72) be amended to allow additional language for calcium and vitamin D and osteoporosis. FDA conducted its review of the effects of calcium and vitamin D on osteoporosis consistent with how the agency conducted its review for calcium and the osteoporosis health claim. Thus, the agency examined the effects of calcium and vitamin D on direct measures of bone status (i.e. bone mineral density (BMD) and bone mineral content (BMC)).

According to the National Institutes of Health (NIH) Consensus Statement “Osteoporosis, Prevention, Diagnosis, and Therapy” (hereinafter, the 2000 NIH Consensus Statement),” osteoporosis is a skeletal disorder characterized by compromised bone strength predisposing to an increased risk of fracture (Ref. 2). Bone strength is dependent upon bone density and bone quality. Bone density is determined by peak bone mass and amount of bone loss (Ref. 2). Bone quality is a function of architecture, turnover, damage accumulation (e.g., micro fractures) and mineralization (Ref. 2). A fracture occurs when a failure-inducing force (e.g., trauma) is applied to osteoporotic bone (Ref. 2). Thus, osteoporosis is a significant risk factor for fractures, which are commonly described as osteoporotic fractures. The most common osteoporotic fractures are in the vertebrae, hip, and wrist-forearm.

The most common measures of overall bone strength are those for bone mass, namely, BMD and BMC. Bone mineral content is the amount of mineral at a particular skeletal site such as the femoral neck, lumbar spine, or total body; whereas BMD is BMC divided by the area of the scanned region (Ref. 5). As in the 1991 review, FDA has identified bone mass (i.e., BMD, BMC) as a surrogate endpoint for osteoporosis. Thus, FDA used bone mass to identify osteoporosis risk reduction for the purpose of evaluating the scientific evidence for a health claim about calcium, vitamin D, and osteoporosis (Ref. 2).

In humans and other mammals, vitamin D 3 is photosynthesized in the skin by the actions of solar ultraviolet B (UV-B) radiation followed by isomerization, and is the normal dietary form of vitamin D (Ref. 6). Vitamin D 2 is synthesized from ergosterol, a yeast and plant sterol (Ref. 6). Both vitamin D 2 and vitamin D 3 are used as ingredients in conventional food and as dietary ingredients in dietary supplements. Vitamin D 2 and vitamin D 3 are biologically inert, but serve equally as substrates for the production of the biologically active 1,25-dihydroxy-vitamin D 3 (calcitriol) (Ref. 6). Vitamin D 2 or D 3 is hydroxylated at the 25 position in the liver to produce 25-hydroxy-vitamin D 3 (25-hydroxycholecalciferol), which is then further hydroxylated in the kidney to form 1,25-dihydroxy-vitamin D 3 (Ref. 6).

The predominant biological role of vitamin D is to maintain serum calcium and phosphorus concentrations within their normal ranges (Ref. 6). 1,25-dihydroxy-vitamin D 3 acts directly on intestinal mucosal cells to increase absorption of calcium and on bone to further release calcium (Refs. 6 and 13). If dietary calcium intake is inadequate and serum calcium concentration starts to drop below required levels, the parathyroid produces parathyroid hormone (PTH), which then stimulates increased production of 1,25-dihydroxy-vitamin D 3 in the kidney. Together, PTH and 1,25-dihydroxy-vitamin D 3 mobilize calcium from bone and stimulate calcium reabsorption in the kidney (Refs. 6, 13 and 14). To prevent hypercalcemia, the elevated 1,25-dihydroxy-vitamin D 3 acts as a negative feedback regulator on the parathyroid gland to reduce PTH secretion (Ref. 13). In addition, elevated serum calcium concentrations stimulate thyroid production of calcitonin, which lowers the circulating calcium levels by preventing bone resorption and increasing renal calcium excretion (Ref. 15). Thus, 1,25-dihydroxy-vitamin D 3 first acts by increasing intestinal calcium absorption and then, if dietary calcium is not adequate and serum calcium concentration remains low, PTH increases 1,25-dihydroxy-vitamin D 3 levels to increase calcium reabsorption from urine and ultimately liberate calcium stores from bone (Ref. 14).

The petitioner requested, among other things, that the existing health claim for calcium and osteoporosis (§ 101.72) be amended to allow additional language for calcium and vitamin D intake and reduced risk of osteoporosis. The petitioner also requested other amendments, in addition to including calcium and vitamin D as a substance of the claim, and the agency will discuss the scientific evidence about these other proposed amendments in sections IV. B through F of this proposed rule.

FDA has previously concluded that there is significant scientific agreement among qualified experts to support the relationship between calcium intake and reduced risk of osteoporosis (58 FR 2665 at 2672). FDA is not changing this conclusion. There is still significant scientific agreement for such a relationship (Refs. 2, 4, and 16). Since the petitioner has requested that the agency authorize an additional claim for calcium and vitamin D intake and osteoporosis, FDA focused its review on studies that examined the effects of calcium and vitamin D intake on osteoporosis risk. In order to authorize a health claim relating calcium and vitamin D intake to reduced risk of osteoporosis, FDA will consider whether there is significant scientific agreement among qualified experts to support the relationship between calcium and vitamin D intake and reduced risk of osteoporosis. FDA's review of the evidence to support an amendment to include calcium and vitamin D as a substance of the calcium and osteoporosis health claim was conducted consistent with FDA published guidance on significant scientific agreement in the review of health claims (Ref. 17).

The petition cited 221 references that summarized 3 bodies of evidence in support of the health claim for calcium and vitamin D intake and risk of osteoporosis. These included studies on the relationship between: (1) Calcium intake and risk of osteoporosis, (2) vitamin D intake and risk of osteoporosis, and, (3) calcium and vitamin D intake and risk of osteoporosis. Scientific conclusions about the substance-disease relationship cannot be drawn from studies that did not analyze whether calcium plus vitamin D, together, were associated with risk factors for osteoporosis (BMD or BMC).

FDA identified a total of 13 intervention studies in the petition on calcium and vitamin D intake and risk of osteoporosis for its review of the proposed calcium and vitamin D and osteoporosis health claim (Refs. 18 through 30). Scientific conclusions about the substance-disease relationship could not be drawn from three of these studies. Specifically, Aloia et al. (1994) (Ref. 18) and Prestwood et al. (1999) (Ref. 28) did not include appropriate control groups that would allow assigning any observed effects to calcium and vitamin D supplementation (Ref. 31). Therefore, it could not be determined whether changes in the endpoint of interest were due to calcium or vitamin D intake or to unrelated and uncontrolled extraneous factors (Ref. 31). In addition, Prestwood et al. (1999) measured outcomes (biochemical markers of bone formation and resorption) that are not recognized as valid surrogate endpoints for osteoporosis. The only validated surrogate endpoints for osteoporosis are BMD and BMC. Grados et al. (2003) (Ref. 25) studied women with vitamin D deficiency and the results could not be extrapolated to the general population. Nutrient status and metabolism can be severely altered when an individual is malnourished. Vitamin D deficiency causes abnormalities in calcium and bone metabolism (Ref. 6). Vitamin D deficiency will cause a decrease in ionized blood calcium, which will lead to an increase in the production of secretion of parathyroid hormone (Ref. 6). The effect of vitamin D on calcium and bone metabolism can be different than the effect of the same nutrient on healthy, well-nourished individuals. Therefore, scientific conclusions cannot be drawn from this study.

Thus, FDA identified 10 reports of 8 intervention studies, which included 2 followup studies (Refs. 21 and 24), from which scientific conclusions could be drawn about the effects of calcium and vitamin D intake on reduced risk of osteoporosis (Refs. 19 through 24 and Refs. 26, 27, 29, and 30).

Orwoll et al. (1990) (Ref. 27) was a 3-year, randomized, double-blind placebo-controlled study that provided U.S. men (n=36 control group; n=41 treatment group; mean of 58 years for both groups) a supplement containing 1,000 mg/day calcium and 1,000 IU/day vitamin D or a placebo. IU is equivalent to the specific biological activity of 0.025 microgram (µg) of vitamin D 3 (i.e., 1 mcg equals 40 IU; 1 milligram (mg) equals 40,000 IU). There was no effect of calcium and vitamin D supplementation on BMC (radius, vertebrae) when compared to men receiving a placebo (Ref. 27).

Chapuy et al. (1992, 1994) reported the results from 1 1/2 years (Ref. 20) and 3 years (Ref. 21) supplementation of French women (n=1,634/group; 84 years mean) with 1,200 mg/day calcium and 800 IU/day vitamin D or a placebo. In this randomized, double-blind placebo-controlled study, calcium and vitamin D supplementation resulted in significantly fewer hip and non-vertebral osteoporotic fractures (Refs. 20 and 21) and improved proximal femur BMD (Ref. 21), compared with the placebo group.

Dawson-Hughes et al. (1997) (Ref. 23) provided a placebo or a supplement containing 500 mg/day calcium and 700 IU/day vitamin D to U.S. men and women (n=187-202/group; approximately 70 years mean) in a 3-year randomized, double-blind placebo-controlled study. For all subjects, calcium and vitamin D produced a benefit in BMD (femoral neck, spine, total body) and reduced non-vertebral fracture incidence compared with subjects given placebo. When the BMD results for men (n=86) and women (n=101) were analyzed separately, men had significant effects at all three sites; whereas only total body bone loss was significantly reduced in women. Two years following withdrawal of the calcium and vitamin D supplements, BMD returned to levels observed in the placebo group, with the exception of total body BMD in men, which remained significantly higher in men previously given calcium and vitamin D (Ref. 24).

Kreig et al. (1999) (Ref. 26) was a 2-year randomized, controlled study in which French women (n=50-53/group; 84 years mean) were given a supplement containing 1,000 mg/day calcium and 880 IU/day vitamin D or left untreated. Bone density was significantly higher in the supplemented group compared to the untreated group (Ref. 26).

Baeksgaard et al. (1998) (Ref. 19) was a 2-year, randomized, double-blind placebo-controlled study in which Danish women (n=63-69/group; 62.5 years mean) were given a placebo or a supplement containing 1,000 mg/day calcium and 560 IU/day vitamin D. A significant increase in lumbar spine BMD was observed in the supplemented group compared to the placebo group (Ref. 19).

Sosa et al. (2000) (Ref. 29) provided either a supplement containing 1,000 mg/day calcium or 1,000 mg/day calcium and 1,520 IU/day vitamin D to Spanish women (n=28-30/group; 78 years mean) in a 1-year randomized, active controlled study. Calcium and vitamin D supplementation significantly increased femoral neck BMD compared to the calcium only group. No differences between the groups were observed for fracture incidence (Ref. 29).

Dawson-Hughes et al. (1991) (Ref. 22) provided a supplement containing 377 mg/day calcium or 377 mg/day calcium and 400 IU/day vitamin D to U.S. women (n=124-125/group; 61 years mean) for 1 year in a randomized, double-blind active-controlled study. Spine BMD was significantly higher in the women that received calcium and vitamin D compared to women who received calcium alone (Ref. 22).

Jackson et al. (2006) (Ref. 30) provided a supplement containing 1,000 mg/day calcium and 400 IU/day vitamin D 3 to postmenopausal women (n=16,936; 62 years mean) for 7 years who were already enrolled in a Women's Health Initiative (WHI) clinical trial. This was a randomized, double-blind placebo controlled study. Total hip BMD was significantly higher in women who received calcium and vitamin D compared to women in the placebo group. Spine and whole-body BMD were not significantly different between the groups (Ref. 30).

The petition identified 8 observational studies on calcium and vitamin D intake, consisting of 1 prospective cohort (Ref. 32), 2 prospective sub-cohorts (Ref. 33 and 34), and 5 cross-sectional studies (Refs. 35 through 39). The eight observational studies either calculated calcium and/or vitamin D intake from estimates of dietary intake and/or dietary supplements.

When calcium or vitamin D intake is calculated from estimates of intake of calcium or vitamin D containing foods or dietary supplements, human and measurement error can occur, affecting the accuracy of the calculation. In observational studies that calculate nutrient intake from conventional foods or dietary supplements, measure of calcium and/or vitamin D intake is based on recorded dietary intake methods, such as food frequency questionnaires, diet recalls, or diet records, in which the type and amount of foods and dietary supplements consumed are estimated. Calcium and vitamin D levels in conventional foods are then estimated using typical calcium and vitamin D concentration values for the food product category, based on a source such as the U.S. Department of Agriculture National Nutrient Database for Standard Reference. A common weakness of observational studies is the limited ability to ascertain the actual food, dietary supplement or nutrient intake for the population studied as a result of poor memory, over-, or underestimation of portion sizes and recall bias (Ref. 40). Thus, it is difficult to ascertain an accurate amount of the nutrient consumed based on reports of dietary intake from conventional foods and dietary supplement use. Furthermore, the bioavailability of calcium from foods can vary due to food processing and cooking procedures that are not indicated in a recorded dietary intake method or not indicated nor available for foods that have an assigned calcium concentration value (Ref. 41).

In addition, conventional foods and multivitamin and multi-ingredient supplements contain not only calcium and vitamin D, but also other nutrients that may be associated with the metabolism of calcium and vitamin D on bone health. Thus, it is not possible to attribute any observed associations to calcium and vitamin D intake alone from conventional foods and/or multivitamin and multi-ingredient supplements because of the potential confounding effects from the other components contained in the conventional foods and dietary supplements. Because conventional foods and dietary supplements consist of many nutrients and substances, it is difficult to study the nutrient or food components in isolation (Ref. 42). For instance, bone health requires more than just calcium and vitamin D (Refs. 4 to 6). Most notably, phosphorus and magnesium make up more than half of bone mineral density (Refs. 4 and 5). Insufficient levels of magnesium may interfere with the ability to metabolize calcium (Ref. 4).

As discussed previously, when evaluating the relationship between vitamin D and calcium and a reduced risk of osteoporosis, there are inherent problems associated with an observational study design in assessing vitamin D and calcium intake from conventional food and/or dietary supplements and in controlling for the intake of other nutrients that may affect vitamin D and calcium metabolism. Based on the problems associated with the use of an observational study design to assess a relationship between calcium and vitamin D intake and a reduced risk of osteoporosis, none of the eight observational studies provided, nor could they provide, a sufficient assessment of the intake of calcium and vitamin D from foods and/or dietary supplements in order to evaluate such a relationship. In addition, none of the eight observational studies controlled for, nor could they control for, the intake from other components in foods and dietary supplements that are associated with the metabolism of calcium and vitamin D, which control is necessary in order to evaluate the relationship between calcium and vitamin D and a reduced risk of osteoporosis. Further, two of these studies (Refs. 34 and 36) measured serum vitamin D levels, which are not a valid biomarker of dietary vitamin D intake because serum levels reflect the cumulative effect of both exposure to sunlight and dietary intake (Ref. 6). For the previously stated reasons, FDA concludes that no scientific conclusions about the relationship between calcium and vitamin D intake and the risk of osteoporosis can be drawn from the eight observational studies on conventional foods or dietary supplements.

In its review of the scientific evidence, FDA also considered conclusions from the 2000 NIH Consensus Statement, which was submitted with the petition, and the Surgeon General Report “Bone Health and Osteoporosis” (hereafter, the 2004 Surgeon General Report) (Refs. 2 and 4). The 2000 NIH Consensus Statement concluded that “adequate calcium and vitamin D intake are crucial to develop optimal peak bone mass and to preserve bone mass throughout life” and further, “osteoporosis occurs in all populations and at all ages” (Ref. 2). Similarly, the 2004 Surgeon General Report states that “calcium and vitamin D intake and physical activity are now known to be major contributors to bone health for individuals of all ages, and while bone disease often strikes late in life, the importance of beginning prevention at a very young age and continuing it throughout life is now well understood” (Ref. 4). These results extend the scientific conclusions that not only calcium reduces the risk of osteoporosis but that calcium and vitamin D also reduce the risk of osteoporosis.

The majority of the intervention studies FDA evaluated and submitted with the petition established that calcium and vitamin D significantly reduces the risk of osteoporosis (Refs. 18 through 29). One intervention study (Ref. 29), which compared calcium supplementation to supplementation with calcium and vitamin D showed no difference in fracture incidence but did demonstrate significantly increased femoral neck BMD with calcium and vitamin D. Another study (Ref. 22) showed a significantly higher spine BMD in women with calcium and vitamin D supplementation compared to calcium supplementation alone. Therefore, the two studies (Refs. 22 and 29) that compared supplementation with calcium to calcium and vitamin D suggest that the combination of calcium and vitamin D may enhance the effects of reduction in risk of osteoporosis when compared to calcium alone. The role of vitamin D in enhancing the bioavailability of calcium through increased intestinal absorption of dietary calcium, and increased renal reabsorption of urinary calcium is well established. Based on its review of the publicly available evidence pertaining to calcium, vitamin D, and osteoporosis, FDA tentatively concludes that there is sufficient evidence to amend § 101.72 to include vitamin D so that, in addition to claims for calcium and osteoporosis, additional claims can be made for calcium and vitamin D and osteoporosis. Accordingly, FDA is proposing to amend § 101.72 to authorize an additional health claim for calcium and vitamin D and reduced risk of osteoporosis.

The agency is not making any changes to the nature of the food, including dietary supplements, labeled with the calcium and osteoporosis health claim (§ 101.72(c)(2)(ii)). Those requirements are that: (1) The food shall meet or exceed the requirements for a “high” level of calcium as defined in § 101.54(b), i.e., the food must contain 20 percent or more of the RDI for calcium per RACC; (2) the calcium content of the product shall be assimilable; (3) dietary supplements shall meet the United States Pharmacopeia (U.S.P.) standards for disintegration and dissolution applicable to their component calcium salts, except that dietary supplements for which no U.S.P. standards exist shall exhibit appropriate assimilability under the conditions of use stated on the product label; and (4) the food or total daily recommended supplement intake shall not contain more phosphorus than calcium on a weight per weight basis.

The general requirements for health claims (21 CFR 101.14(d)(2)(vii)) provide that, if the claim is about the effects of consuming the substance at other than decreased dietary levels, the level of the substance must be sufficiently high and in an appropriate form to justify the claim. If a definition for the use of the term “high” for the substance has been established, the substance must be present at a level that meets the requirements for the use of that term. A “high” claim about the level of a nutrient in a food in relation to the RDI established for that nutrient requires that the food contain 20 percent or more of the RDI per RACC (see § 101.54(b)). The RDI for vitamin D is 400 IU. Thus, a conventional food must contain 20 percent or more of the RDI for vitamin D per RACC (i.e., at least 80 IU) to be eligible for the additional calcium, vitamin D and osteoporosis health claim. A dietary supplement must contain 20 percent or more of the RDI for vitamin D per RACC (see Table 2 of § 101.12(b)).

Accordingly, FDA is proposing that, in order for a food to be eligible for the additional calcium and vitamin D and osteoporosis health clam the food must: (1) Be eligible to bear a claim for the calcium and osteoporosis health claim in § 101.72, (2) meet or exceed the requirements for a “high” level of vitamin D as defined in § 101.54(b), and (3) meet all of the general health claim requirements set forth in § 101.14.

As noted in the section I of this proposed rule, FDA published a proposed rule entitled “Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims” (the 1995 proposal), to amend several provisions of the regulations on nutrient content claims and health claims to increase the flexibility in the use of nutrient content claims and health claims on food products (60 FR 66206). The agency either extended or reopened the comment period four times for the 1995 proposal, in response to request from stakeholders (61 FR 11793, March 22, 1996; 62 FR 3635, January 24, 1997; 62 FR 11129, March 11, 1997; and 69 FR 24541, May 4, 2004). The agency received approximately 160 comments in response to the proposed rule. The comments specific to the requirements for the calcium and osteoporosis health claim generally supported the agency's tentative proposals. Specific comments are discussed below as they pertain to the appropriate sections.

In the 1995 proposal, FDA proposed to amend several specific requirements to the nature of the claim for the calcium and osteoporosis health claim (60 FR 66206). The first required element for the calcium and osteoporosis health claim is contained in § 101.72(c)(2)(i)(A) and provides that: “The claim makes clear that adequate calcium intake throughout life is not the only recognized risk factor in this multifactorial bone disease by listing specific factors, including sex, race, and age that place persons at risk of developing osteoporosis and stating that an adequate level of exercise and a healthful diet are also needed.” The original intent of presenting the information as specified in § 101.72(c)(2)(i)(A) was to convey the message that for any individual several factors define disease risk.

FDA's tentative decision to amend § 101.72(c)(2)(i)(A) in the 1995 proposal was based, in part, on the 1994 NIH Consensus Statement on optimal calcium intake, which was published after authorization of the calcium and osteoporosis final rule. The first of several significant conclusions from the 1994 NIH Consensus Statement was that a large percentage of Americans did not meet the currently recommended guidelines for optimal calcium intake (Ref. 43). Because of the need to correct this public shortfall and to improve bone health, which would reduce the risk of osteoporosis, FDA tentatively concluded that a singular focus on achieving and maintaining adequate calcium intake as a required element of the claim was important (60 FR 66206 at 66216). In the 1995 proposal, FDA also acknowledged, that the number of food products bearing health claims, during this time, was not as great as the agency had anticipated and FDA was concerned that manufacturers may have been disinclined to use such lengthy health claims on food labels. (id.) These concerns coupled with the fact that most Americans, regardless of sex, race, or age, were not meeting the recommended guidelines for optimal calcium intake led the agency to reevaluate the requirement in § 101.72(c)(2)(i)(A). Accordingly, FDA proposed to simplify § 101.72(c)(2)(i)(A) by limiting the requirement to a balanced statement that reflects the importance of the nutrient calcium over a lifetime in a healthful diet to reduce osteoporosis risk, but that does not imply that calcium is the only risk factor for the development of osteoporosis. FDA also proposed to replace the provision in § 101.72(c)(2)(i)(A) that the specific risk factors and the need for an adequate level of exercise be stated in the claim, with the more simple requirement that the claim not imply that adequate dietary calcium intake is the only recognized risk factor for a reduced risk of osteoporosis (60 FR 66206 at 66216 and 66217). In concert with these proposed changes to § 101.72(c)(2)(i)(A), FDA provided that the claim may list the sex, age, or race of populations at risk for osteoporosis, or the need for an adequate level of exercise as optional information (60 FR 66206 at 66217).

The agency did not receive any comments opposing these proposed amendments. Rather, several comments that addressed this issue supported the agency's tentative amendments to § 101.72(c)(2)(i)(A). The agency considered these comments when responding to the health claim petition submitted by The Beverage Institute for Health and Wellness.

The petitioner requested that the agency amend § 101.72(c)(2)(i)(A) to eliminate reference to age, sex, race, and the need for an adequate level of exercise. The petitioner did not include the provision in § 101.72(c)(2)(i)(A) concerning calcium's role in a ‘healthful diet’ and did not state why such provision was not included in their proposed amendment. The petitioner stated that their request for eliminating reference to age, sex, and race in the claim was supported by scientific evidence establishing that calcium or calcium and vitamin D reduces the risk of osteoporosis in all age groups of both sexes and in all races. The petitioner stated that their request for eliminating reference to the need for an adequate level of exercise from the claim was supported by scientific evidence, submitted with the petition, showing that calcium or calcium and vitamin D can reduce the risk osteoporosis regardless of the level of physical activity.

The agency agrees with the petitioner that the claim no longer needs to list specific risk factors for the development of osteoporosis, including sex, race, and age. However, the agency also tentatively concludes that a reference to a “healthful diet” and to adequate physical activity is still a necessary part of the claim, as well as the importance of adequate calcium or adequate calcium and vitamin D intake throughout life.

The 2000 NIH Consensus Statement concluded that “osteoporosis occurs in all populations and at all ages” and that “adequate calcium and vitamin D intake are crucial to develop optimal peak bone mass and to preserve bone mass throughout life” (Ref. 2). Furthermore, evidence provided in the 2004 Surgeon General's Report as well as the 2000 NIH Consensus Statement establishes that the benefits of calcium or calcium and vitamin D on prevention of bone diseases, including osteoporosis, are not dependent on age and not specific to any subpopulation in the United States (Refs. 2 and 4).

Osteoporosis occurs in all populations at all ages (Ref. 4). Osteoporosis is the major cause of fractures in the elderly, both men and women. It begins later in men than women (Ref. 2). In women it often follows menopause, especially in white women. Osteoporosis is a disease that takes many years to develop and most often is not discovered until the later years. For every 10 white women, 4 by age 50 or older in the United States will experience a hip, spine, or wrist fracture sometime during the remainder of their lives and for white men the number is 13 percent (Ref. 44). Though the lifetime risk for types of fractures is less in men and nonwhite women, it does represent a significant risk and may be increasing in certain populations, such as Hispanic women (Ref. 45). Because of the mistaken view that osteoporosis is a disease that affects postmenopausal white women, it often goes undetected in men and racial and ethnic minorities (Ref. 4). Risk of developing osteoporosis is likely to increase for all ethnic groups as people's lifespan increases (Ref. 4).

Achieving and maintaining optimal bone health is a process that occurs in both men and women throughout the lifespan (Ref. 2). Bone mineral density declines with age in both men and women. Peak bone mass is achieved at an early age and is a life-long determinant of skeletal health. Calcium is the most important nutrient for achieving and maintaining good skeletal health and vitamin D is required for optimal absorption and utilization of calcium (Refs. 2 and 4). Thus, specific reference to sex, race, and age is not necessary since the benefits of dietary intake of calcium, or calcium and vitamin D would apply to both sexes and all age and race categories.

Studies have shown that a well-balanced diet is important for bone health throughout life (Ref. 4). Calcium and vitamin D remain the primary nutrients required for good bone health and consuming diets that include foods that contain these nutrients is critical. In addition, other nutrients such as vitamin K, vitamin C, copper, manganese, zinc, potassium, iron, and others may also play a role in optimal bone health (Ref. 4). Thus, since many nutrients are involved in bone health, it is important to consume a well-balanced diet that consists of a variety of foods, including grains, fruits, vegetables, nonfat or low-fat dairy products or other calcium-rich foods, meat or beans.

In the 1995 proposal, FDA stated that it included a reference to a “healthful diet” in § 101.72(c)(2)(i)(A) for consistency with the general requirement in § 101.14(d)(2)(v) that “the claim enable the public ***to understand the relative significance of such information in the context of a total daily diet” (60 FR 66206 at 66216). Similar to what the agency concluded in the 1995 proposed rule for the effect of adequate calcium intake, the effect of calcium and vitamin D can only be realized if the calcium and vitamin D is a part of a healthy, well-balanced diet that provides all essential and other nutrients to optimize nutritional health status. Thus, the agency is retaining the requirement in § 101.72(c)(2)(i)(A) that the claim make clear the importance of adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake over a lifetime in a healthful diet is essential to reduce osteoporosis risk.

Physical activity, along with intake of calcium and vitamin D, is known to be a major contributor to bone health for people of all ages (Ref. 4). In order to reduce the risk of osteoporosis, it is important to begin physical activity at an early age and continue throughout life. Physical activity needs to be maintained for optimal bone health. Physical activity helps to increase or preserve bone mass and reduces the risk of falls (Ref. 4). Studies have shown that physical activity, as well as diet, are responsible for 10 to 50 percent of bone mass and structure (Ref. 4). Physical activity plays an important role in skeletal health. Thus, physical activity has a significant impact on one's risk for developing osteoporosis.

Two studies have shown that physical activity can have a more beneficial effect in infants or young children if these groups have adequate calcium intakes (Refs. 46 and 47). As with children, the positive effects of physical activity and calcium in older adults on bone health has also been shown (Ref. 4). Thus, there is a synergistic effect between intake of calcium and physical activity.

Both the more current 2004 Surgeon General's Report (Ref. 4), and the 2000 NIH Consensus Statement continue to emphasize the importance of physical activity on bone health (Ref. 2). Thus, because physical activity is integral to bone health, along with the need for adequate calcium, and, as applicable, calcium and vitamin D, the agency is requiring a reference to the need for physical activity as part of the health claim.

In summary, FDA tentatively concludes that specific reference to sex, race, age in the claim is no longer necessary since the benefits of calcium or calcium and vitamin D apply to both sexes at all ages and race categories. FDA also tentatively concludes, however, that the nutritional status of the diet and physical activity have a significant impact on bone health, and thus, one's risk of developing osteoporosis. Accordingly, FDA, is proposing to eliminate the provision in § 101.72(c)(2)(i)(A) that specific risk factors including sex, race, and age be listed in the claim, but to retain the provisions concerning a healthful diet and exercise. Thus, the proposed revision to § 101.72(c)(2)(i)(A) reads as follows: “The claim makes clear the importance of adequate calcium intake or when appropriate, adequate calcium and vitamin D intake throughout life, in a healthful diet along with physical activity are essential to reduce osteoporosis risk. The claim does not imply that adequate calcium intake or when appropriate, adequate calcium and vitamin D intake is the only recognized risk factor for the development of osteoporosis.”

FDA is requesting comments on whether the provision to specify sex, race, or age in the claim language should be retained and why.

The second element for the calcium and osteoporosis claim is contained in § 101.72(c)(i)(2)(B) and provides that: “The claim does state or imply that the risk of osteoporosis is equally applicable to the general United States population. The claim shall identify the populations at particular risk for the development of osteoporosis. These populations include White (or the term (“Caucasian”) women and Asian women in their bone forming years (approximately 11 to 35 years of age or the phase “during teen or early adult years” may be used). The claim may also identify menopausal (or the term “Middle-aged”) women, persons with a family history of the disease, and elderly (or “older”) men and women as being at risk.”

FDA's tentative decision to amend § 101.72(c)(2)(i)(B) in the 1995 proposed rule was based on the 1994 NIH Consensus Statement and an FDA report published in 1995 on consumer understanding of health claims (hereinafter referred to as the 1995 FDA health claims report (Ref. 48)).

The 1994 NIH Consensus Statement concluded that the two most important factors that influence the occurrence of osteoporosis are optimal bone mass attained in the first two or three decades of life and the rate at which bone loss occurs in later years (Ref. 43). Thus, the 1994 NIH Consensus Statement did not ascribe the relative risk of osteoporosis on the basis of race or ethnicity.

As part of the 1995 FDA health claims report, FDA tested participants understanding of a model calcium and osteoporosis health claim, such as the following: “Regular exercise and a healthy diet with enough calcium helps teen and young adult white and Asian women maintain good bone health and may reduce their high risk of osteoporosis later in life.”

Results from this study (Ref. 48) showed that minority women were unanimous in objecting to the inference that black American women do not need calcium and questioned the accuracy of the information contained in the claim. All of the survey participants recognized that calcium is essential for everyone. Although there was some recognition based on prior knowledge that younger women need to be concerned about osteoporosis, no participant thought the model claim communicated that concept very well.

The agency did not intend that the calcium and osteoporosis health claim imply that calcium is not needed by any individual or specific population. Given that calcium is essential for every person, the agency attempted to present this disease claim in a truthful, nonmisleading, and scientifically valid manner. Likewise, the agency tentatively concluded in the 1995 proposal that greater use in food labeling of the calcium and osteoporosis health claim, articulated in a manner that will be accepted and followed by consumers, could help support significant strides in improving calcium intake in all segments of the U.S. population. Thus, the agency proposed to revise § 101.72(c)(2)(i)(B) by removing the provision that the claim identify by race and ethnicity those populations at particular risk for the development of osteoporosis, but to retain identification of teen and young adult women, irrespective of race as the focus of the claim (60 FR 66206 at 66218).

All comments received from the 1995 proposal regarding identification of the at-risk population by race and ethnicity agreed with FDA's tentative decision to remove that requirement from § 101.72(c)(2)(i)(B). However, most of the same comments disagreed with the tentative decision to retain a focus on teen and young adult women. One comment stated that, if the agency were to rely on the 1994 NIH Consensus Statement (Ref. 43) in making its decision, the health claim would also have to cite older people as a second group for whom calcium intake is important, which would lengthen the claim sufficiently to discourage its use on food labels. It said that requiring the claim to emphasize the calcium needs of young adults and teenagers might lead other consumers to conclude that calcium is not important for them. The comment stated that nearly all teens and adults will need encouragement to reach the high levels of calcium, 1,000 to 1,500 mg per day, recommended by the 1994 NIH Consensus Statement. Several comments urged the agency to allow calcium and osteoporosis claims to express the lifelong need for adequate dietary calcium without requiring the identification of any particular population segment as being at a higher than average risk for the disease. The comments stated that a claim such as “adequate calcium in a healthful diet throughout life may reduce the risk of osteoporosis” would be appropriate. The agency considered these comments when responding to the health claim petition submitted by The Beverage Institute for Health and Wellness.

The petitioner included, in proposed language for § 101.72(c)(2)(i)(B), that the claim not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population. In addition, the petition included, as optional, a statement that identifies other populations at risk for developing osteoporosis, including women in their bone forming years from approximately 11 to 35 years of age. The petitioner provided scientific evidence that calcium and calcium and vitamin D reduce the risk of osteoporosis in both men and women in all age groups regardless of race or ethnicity.

Scientific evidence from both the Surgeon General's Report on Bone Health and Osteoporosis and the 2000 NIH Consensus Statement shows that osteoporosis occurs in both sexes at all ages and that adequate calcium and vitamin D are essential to the development of peak bone mass and the preservation of bone mass throughout life (Refs. 2 and 4).

Osteoporosis does not affect everyone to the same degree (Ref. 4). Osteoporosis is most prevalent in postmenopausal women (Ref. 4), and white postmenopausal women experience almost 75 percent of hip fractures and have the highest age adjusted fracture incidence (Ref. 2). Both men and women experience an age-related decline in BMD starting in midlife, and men, especially older men do develop osteoporosis (Ref. 4).

Based on the Surgeon General's Report on Bone Health and Osteoporosis and the 2000 NIH Consensus Statement, specifically that osteoporosis is most prevalent in White postmenopausal women (Refs. 2 and 4), FDA tentatively concludes that the provision in § 101.72(c)(2)(i)(B) that the claim must identify certain populations for particular risk for osteoporosis as White or Asian women between the ages of 11 and 35 is no longer correct.

FDA also tentatively concludes that the provision in § 101.72(c)(2)(i)(B) providing that the claim not state or imply that the risk of osteoporosis is equally applicable to the general population is no longer appropriate. While the risk of osteoporosis is not equally applicable to the general population, in the sense that there may be some subpopulations that are at a greater risk for developing osteoporosis than others, osteoporosis still occurs in all populations at all ages (Refs. 2 and 4). Since osteoporosis is most prevalent and thus more associated with White postmenopausal women, it often has gone unrecognized in men and other age and ethnic populations (Refs. 2 and 4). Thus, FDA tentatively concludes that it is no longer necessary to limit the wording of the claim to targeted subgroups, even though such subgroups may be at a relatively greater risk than others in the general population. Accordingly, FDA is proposing to eliminate the requirement in § 101.72(c)(2)(i)(B).

FDA is requesting comments about whether the identification of any population or populations at particular risk of osteoporosis should be required or optional in the claim language and why.

Section 101.72(c)(2)(i)(C) of the calcium and osteoporosis health claim established a requirement for identifying the mechanism whereby adequate dietary calcium over a lifetime reduces the risk of osteoporosis as described below: “The claim states that adequate calcium intake throughout life is linked to reduced risk of osteoporosis through the mechanism of optimizing peak bone mass during adolescence and early adulthood. The phrase “build and maintain good bone health” may be used to convey the concept of optimizing peak bone mass. When reference is made to persons with a family history of the disease, menopausal women, and elderly men and women, the claim may also state that adequate calcium intake is linked to reduced risk of osteoporosis through the mechanism of slowing the rate of bone loss.” The agency concluded in developing this requirement, for the calcium and osteoporosis health claim, that it was important for consumers to have a basic understanding of the biological and physiological mechanisms by which adequate dietary intake of calcium achieves a reduced risk of osteoporosis (60 FR 66206 at 66218).

In the 1995 proposal, FDA proposed to make the statement of the mechanism by which calcium intake affects the risk of osteoporosis optional information (60 FR 66206 at 66218). This tentative conclusion was based on information contained in the 1995 FDA health claims report, which focused on consumer understanding of health claims (Ref. 48). The 1995 FDA health claims report found that because participants had learned elsewhere that calcium intake is related to general bone health, they thought the food label was not the right means for conveying this information. The awareness by consumers that calcium's ability to “build and maintain good bone health” is the mechanism whereby risk of osteoporosis is reduced raised the question as to whether there was a need to state that fact in a health claim. Thus, in the interest of streamlining the claim, FDA proposed to make the statement of the mechanism by which calcium intake affects the risk of osteoporosis optional information (60 FR 66206 at 66218). No comments were received objecting to this aspect of the 1995 proposal.

The petitioner requested that the agency allow information on the mechanism by which calcium reduces the risk of osteoporosis to be optional instead of required, and to extend this optional information to the additional calcium and vitamin D and osteoporosis claim.

Based on the petitioner's request and FDA's tentative conclusions in the 1995 proposal that many consumers were aware that calcium was necessary for good bone health, FDA is proposing to eliminate the requirement in § 101.72(c)(2)(i)(C) that the claim state the mechanism by which calcium reduces osteoporosis risk. FDA is also proposing that information of the mechanism by which calcium reduces the risk of osteoporosis may be optional, for either the calcium or the newly proposed calcium and vitamin D and osteoporosis claim. FDA requests comments on the proposed amendments to § 101.72(c)(2)(i)(C).

Section 101.72(c)(2)(i)(E) contains a conditional requirement that a calcium and osteoporosis health claim include a statement that reflects the limit on the benefit derived from dietary calcium intake when the food contains 40 percent or more of the RDI of 1,000 mg of calcium per day or 400 mg or more of calcium per RACC as defined in § 101.12(b).

In the 1995 proposal, FDA proposed to amend this requirement by increasing the amount of calcium present in a food that would trigger the conditional requirement in § 101.72(c)(2)(i)(E), from 400 mg per RACC to 1,500 mg per day (60 FR 66206 at 66219). FDA based this proposal on conclusions from the NIH 1994 Consensus Statement regarding methods to achieve optimal calcium intake and the absence of reported adverse effects with moderate supplementation up to 1500 mg/day (60 FR 66206 at 66219). FDA's proposal to increase the threshold level in § 101.72(c)(2)(i)(E) was also based on several Congressional findings in the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417) (60 FR 66206 at 66218). One of those findings identified a link between ingestion of certain nutrients or dietary supplements and reduced risk of several chronic diseases, including osteoporosis, and stated that the Federal government should not take any actions to impose unreasonable regulatory barriers that limit or slow the flow of safe products and accurate information to consumers.

One comment did not support FDA's tentative decision to amend § 101.72(c)(2)(i)(E) to change the threshold from 400 mg of calcium per RACC to 1,500 mg per day. The comment stated that a statement that reflects the limit on the benefit derived from dietary calcium intake is needed to protect consumers from over consumption of this nutrient. The comment stated that 400 mg of calcium per RACC should be retained as the threshold since most calcium-rich conventional foods do not contain more than that amount and would not have to bear this type of statement as part of a calcium and osteoporosis health claim. The comment maintained that this approach is appropriate because such a statement on conventional foods would appear to run at cross purposes with the goal to increase calcium consumption and would be inconsistent with the conclusion in the 1994 NIH consensus statement that “the preferred source of calcium is through calcium-rich foods such as dairy products.”

The comment maintained that, because calcium supplements provide calcium in addition to the calcium that consumers get from conventional foods, it is important for consumers to know the maximum recommended safe dose, and cited a second conclusion from the 1994 NIH consensus statement that “practices that might encourage total calcium intake to approach or exceed 2,000 mg per day seem more likely to produce adverse effects and should be monitored carefully.” The comment suggested that consumers should be made aware that a total daily intake of 2,000 mg of calcium from conventional foods and dietary supplements appears to be safe, but that higher intakes provide no further benefit. The comment maintained that a lower threshold for a statement of the limits of benefit on calcium supplements would not limit the flow of these supplements to those who need them but would provide information to help prevent their overuse by consumers.

The comment stated further that if FDA did raise the 400 mg calcium per RACC threshold, several issues should be addressed. The comment stated that FDA's proposal to require that the statement of limited benefit apply to foods that provide more than 1,500 mg of calcium per day means that the requirement pertains only to supplements and not to foods since, for conventional foods, the requirement must be on a per reference amount basis. The comment stated that the per day basis could only apply to supplements.

Noting that the highest recommendation for calcium intake in the 1994 NIH consensus statement was 1,500 mg calcium per day, the comment maintained that this level represents total dietary calcium intake from conventional foods and dietary supplements. The comment stated that 1,500 mg should not be the threshold level for a limited benefit statement. The comment argued that setting the threshold higher than 1,000 mg per day would encourage supplementation to an inappropriately high level. The comment pointed out that the Food and Nutrition Board's text, “Eat for Life,” advises consumers to avoid taking vitamin or mineral dietary supplements in excess of the U.S. Recommended Dietary Allowance (currently, the Reference Dietary Intake) in any one day—for calcium, that amount is 1,000 mg per day. Accordingly, the comment recommended that the requirement for the limited benefit statement apply only to dietary supplements of calcium whose recommended total daily intake is 1,000 mg or more per day. The agency considered these comments when responding to the health claim petition submitted by The Beverage Institute for Health and Wellness.

The petitioner proposed to adopt the amendments to § 101.72(c)(2)(i)(E) exactly as proposed in the 1995 proposal. The petitioner also requested that FDA not extend a conditional requirement for vitamin D in the proposed additional health claim for calcium and vitamin D and osteoporosis.

FDA has been persuaded to reevaluate the conditional requirement in § 101.72(c)(2)(i)(E) due to the Dietary Reference Intakes (DRIs) established for calcium by the IOM (Ref. 5). DRIs for calcium were established after FDA proposed amendments to the calcium and osteoporosis health claim in the 1995 proposal and after FDA's receipt of the comment opposing FDA's proposed changes to the conditional requirement in § 101.72(c)(2)(i)(E).

In 1997 the IOM conducted a major review of bone-related nutrients (Ref. 4). A goal of the DRI effort was to determine the level of nutrient intake for normal, healthy individuals that would prevent the development of a chronic condition associated with that nutrient (Ref. 5). The DRIs for calcium, which were based on life stages and gender, were set at intake levels of calcium to achieve adequate calcium balance in the body (i.e., AI) and intake levels of calcium that pose no risk of adverse health effects (i.e., UL). The AI for infants up to 6 months of age is 210 mg/day, for infants ages 7 months through 12 months it is 270 mg/day, for children ages 1 through 3 it is 500 mg/day, for children ages 4 through 8 years it is 800 mg/day, for young adults ages 9 through 18 it is 1,300 mg/day, for individuals aged 19 through 50 it is 1,000 mg/day, for individuals ages 51 and above it is 1,200 mg/day, for pregnant and lactating women ages 14 through 18 it is 1,300 mg/day, and for pregnant and lactating women aged 19 and older it is 1,000 mg/day. The UL for all individuals ages 1 and above is 2,500 mg/day (Ref. 5).

The concept of a threshold level of calcium beyond which no further bone benefit occurs is not presented in either the 2004 Surgeon General's Report or the 2000 NIH Consensus Statement (Refs. 2 and 4). Instead these reports discuss the level of calcium at which calcium poses no risk of adverse health effects (i.e., UL).

When the calcium and osteoporosis health claim was initially proposed the scientific evidence supported the concept that a threshold nutrient intake level existed for calcium, below which bone health was jeopardized, and above which no further benefit to bone health occurred (56 FR 60689 at 60692 and 60695). Based on two observational studies that reflected findings that calcium intakes of 800 to 1,000 mg of calcium a day appear to be the upper level of calcium intake beyond which no benefit to bone status has been observed and the observation that higher amounts of calcium are needed in old age, FDA proposed to require that a calcium and osteoporosis claim state that a total dietary intake of calcium greater than 200 percent of the RDI has no known additional benefit (56 FR 60689 at 60698). At the time of the 1991 proposal, the proposed RDI for calcium was 950 mg; 200 percent of the RDI was 1,800 mg.

The agency's current thinking is that a statement reflecting the limit on the benefit derived from dietary calcium intake, as derived in the 1991 proposed rule, is no longer the appropriate approach.

Thus, FDA has tentatively concluded not to require a statement about no known further benefit for foods containing 40 percent or more of the RDI of 1,000 mg or 400 mg calcium per RACC. Accordingly, FDA is proposing to eliminate the requirement in § 101.72(c)(2)(i)(E). The agency requests comments on the proposed amendment to eliminate the requirement in § 101.72(c)(2)(i)(E).

FDA is proposing to revise the title of the regulation to: “Health claims: calcium, vitamin D, and osteoporosis.” This proposed amendment is necessary to reflect the additional claim for calcium and vitamin D and osteoporosis.

Current § 101.72(a) is entitled “Relationship between calcium and osteoporosis.” FDA is proposing to revise § 101.72 to permit additional claims for calcium and vitamin D and osteoporosis. Thus, proposed § 101.72(a) includes information describing the effects of vitamin D on calcium in reducing the risk of osteoporosis, including the scientific evidence that establishes the role of vitamin D in enhancing the effects of calcium in terms of bone health. As a result, FDA is proposing to revise the title for § 101.72(a) to “Relationship between calcium, vitamin D, and osteoporosis.”

Current § 101.72(b) sets out the significance of calcium on osteoporosis, describes the various factors that play a role in the development of osteoporosis, a multifactorial bone disease, and stipulates that adequate calcium intake is not the only recognized risk factor for osteoporosis. Since FDA is proposing to amend § 101.72 so that additional claims can be made for calcium and vitamin D and osteoporosis, § 101.72 (b) will need to address the significance of calcium as well as the significance of calcium and vitamin D on osteoporosis. Therefore, FDA is proposing to: (1) Revise the title of § 101.72(b) to “Significance of calcium or calcium and vitamin D” and (2) make it clear that adequate calcium intake or adequate calcium and vitamin D intake are not the only recognized risk factors in the development of osteoporosis.

Current § 101.72(b)(1) sets out key factors of heredity and being female for identifying those individuals most at risk for developing osteoporosis, and includes information on peak bone mass for Caucasian, Asian women, and American women of African heritage. FDA is proposing to remove § 101.72(b)(1).

Current § 101.72(b)(2) discusses the importance of maintenance of an adequate intake of calcium throughout life for the target subpopulation of adolescent and young adult Caucasian and Asian women. If FDA eliminates, as proposed, the requirement that the claim identify adolescent and young adult Caucasian and Asian women between the ages of 11 and 35, as the populations at particular risk for the development of osteoporosis, § 101.72(b)(2) would no longer be appropriate. Therefore, FDA is proposing to update the information in § 101.72(b)(2) and include it in proposed § 101.72(b). Thus, proposed § 101.72(b) will include information about the importance of maintenance of adequate calcium or adequate calcium and vitamin D throughout life and will read as follows: “ Significance of calcium or calcium and vitamin D . Adequate calcium intake, or adequate calcium and vitamin D intake, is not the only recognized risk factor in the development of osteoporosis, which is a multifactorial bone disease. Maintenance of adequate calcium and vitamin D intakes throughout life is necessary to achieve optimal peak bone mass and to reduce the risk of osteoporosis in later life. However, vitamin D is most effective in this regard when calcium intakes are adequate. Increasing intake of calcium has been shown to have beneficial effects on bone health independent of dietary vitamin D.“

Section 101.72(c)(2)(i) contains requirements for the nature of the claim. FDA is proposing to revise § 101.72(c)(2)(i) to read as follows: “ Nature of the claim . A health claim associating calcium, or when appropriate, calcium and vitamin D, with a reduced risk of osteoporosis may be made on the label or labeling of a food described in paragraphs (c)(2)(ii) and (d)(1) of this section, provided that:”

Current § 101.72(c)(2)(i)(A) contains the specific requirement that the claim makes clear that adequate calcium intake throughout life is not the only recognized risk factor in this multifactorial bone disease by listing specific factors, including sex, race, and age that place persons at risk of developing osteoporosis and stating that an adequate level of exercise and a healthful diet are also needed. The agency is proposing to revise § 101.72(c)(2)(i)(A) to read as follows: “The claim makes clear the importance of adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, throughout life, in a healthful diet along with physical activity, are essential to reduce osteoporosis risk. The claim does not imply that adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, is the only recognized risk factor for the development of osteoporosis;”

Current § 101.72(c)(2)(i)(B) contains the specific requirement that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population. Furthermore, the claim shall identify the populations at particular risk for the development of osteoporosis. These populations include white (or the term “Caucasian”) women and Asian women in their bone forming years (approximately 11 to 35 years of age or the phrase “during teen or early adult years” may be used). The claim may also identify menopausal (or the term “middle-aged”) women, persons with a family history of the disease, and elderly (or “older”) men and women as being at risk. The agency is proposing to remove these specific requirements in § 101.72(c)(2)(i)(B).

Current § 101.72(c)(2)(i)(C) contains the specific requirement that the claim identify the mechanism by which calcium reduces the risk of osteoporosis. The agency is proposing to eliminate this specific requirement and is providing in new § 101.72(d)(4) that information about the mechanism by which calcium, or when appropriate, calcium and vitamin D, reduces the risk of osteoporosis is optional.

Current § 101.72(c)(2)(i)(D) contains the specific requirement that the claim does not attribute any degree of reduction in risk of osteoporosis to maintaining an adequate calcium intake throughout life. The agency is proposing to revise this specific requirement to include information about calcium and vitamin D. Since the agency is proposing to remove the specific requirements in § 101.72(c)(2)(i)(B) and (c)(2)(i)(C), the agency will redesignate newly revised § 101.72(c)(2)(i)(D) as § 101.72 (c)(2)(i)(B). Thus, § 101.72(c)(2)(i)(B) will read as follows: “The claim does not attribute any degree of reduction in risk of osteoporosis to maintaining an adequate dietary calcium intake, or when appropriate, an adequate dietary calcium and vitamin D intake, throughout life.”

Current § 101.72(c)(2)(i)(E) contains the specific requirement that a calcium and osteoporosis health claim include a statement that reflects the limit on the benefit derived from a total dietary calcium intake of greater than 200 percent of the recommended daily intake of calcium (2,000 mg of calcium). The agency is proposing to remove this specific requirement.

Current § 101.72(d)(1) and (d)(2) set out the optional information that may be included in the claim. FDA is proposing to add a new paragraph (d)(1) to include as optional the term “vitamin D” if the food meets or exceeds the requirements for a “high” level of vitamin D as defined in § 101.54(b). Thus, proposed § 101.72(d)(1) will read as follows: “ Optional information . The claim may include the term “vitamin D” if the food meets or exceeds the requirements for a “high” level of vitamin D as defined in § 101.54(b);”

Since FDA is proposing to add new paragraph (d)(1) to § 101.72, the agency is proposing to redesignate current § 101.72(d)(1) and (d)(2) as § 101.72(d)(2) and (d)(3), respectively. The agency is also proposing to revise newly redesignated § 101.72(d)(3) by removing reference to the publication “Dietary Guidelines for Americans.” FDA is proposing to take this action since the “Dietary Guidelines for Americans,” may not necessarily contain information on the number of people in the United States who have osteoporosis. Thus, proposed § 101.72(d)(3) will read as follows: “The claim may include information on the number of people in the United States who have osteoporosis or low bone density. The sources of this information must be identified, and it must be current information from the National Center for Health Statistics, the National Institutes of Health, or the National Osteoporosis Foundation.”

The agency is proposing to add new paragraph (d)(4) to § 101.72, which will provide that the mechanism by which calcium, or when appropriate, calcium and vitamin D, reduces the risk of osteoporosis may be optional information in the claim. Thus, new paragraph (d)(4) would read as follows: “The claim may state that the role of adequate calcium intake, or when appropriate, the role of adequate calcium and vitamin D intake, throughout life is linked to reduced risk of osteoporosis through the mechanism of optimizing peak bone mass during adolescence and early adulthood. The phrase “build and maintain good bone health” may be used to convey the concept of optimizing peak bone mass. When reference is made to persons with a family history of the disease, menopausal women, and elderly men and women, the claim may also state that adequate intake of calcium, or adequate intake of calcium and vitamin D, if applicable, is linked to reduced risk of osteoporosis through the mechanism of slowing the rate of bone loss.”

Since many of the amendments FDA is proposing will alter language used in the calcium and osteoporosis or the additional calcium and vitamin D and osteoporosis health claim, FDA is proposing to revise § 101.72(e) to provide model health claims for the calcium and osteoporosis health claim and to add new paragraph (f) to § 101.72 to provide model health claims for the additional calcium and vitamin D and osteoporosis health claim.

The agency invites comments to any or all of the proposed amendments to § 101.72.

FDA has examined the impacts of the proposed rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The agency believes that this proposed rule is not a significant regulatory action as defined by the Executive order.

The Regulatory Flexibility Act requires agencies to analyze regulatory options that would minimize any significant economic impact of a rule on small entities. The proposed rule, if finalized, amends the current calcium and osteoporosis health claim language and would require changes to the claim language on products currently bearing the health claim. Thus, the only mandatory costs of this proposed rule, if finalized, would be the costs to update the current wording of the calcium and osteoporosis health claim on those products that currently bear the claim. Based on FDA's 2001 Food Labeling and Product Survey (FLAPS) (see discussion in section VI.A.2 “Background” of this document), very few products bear the calcium and osteoporosis health claim. Therefore, because of the limited use of the current calcium and osteoporosis health claim, the agency certifies that the proposed rule will not have a significant economic impact on a substantial number of small entities.

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $122 million, using the most current (2005) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount and has determined that this proposed rule does not constitute a significant rule under the Unfunded Mandates Reform Act.

Current regulations do not permit food producers to claim health benefits for products by linking the intake of vitamin D, when combined with the intake of calcium, with a reduced risk of osteoporosis. However, current regulations do permit food producers to claim health benefits for products by linking calcium intake with a reduced risk of osteoporosis only if they also list the specific risk factors and at-risk subpopulations for osteoporosis, the mechanism by which calcium reduces the risk of osteoporosis, and the limit of the benefits of dietary calcium at certain levels.

Health claims can inform consumers about diet-disease relationships and encourage producers to produce more healthful foods. This proposed rule would allow producers to make more nutrition information related to osteoporosis available to consumers (linking the intake of calcium and vitamin D to the risk of osteoporosis), while eliminating other information currently required to be given to consumers when claiming health benefits relating to the link between calcium intake and the risk of osteoporosis.

Osteoporosis represents a major public health problem in the United States. This disease affects more than 10 million individuals and causes approximately 1.5 million fractures annually. Every year, these lead to 2.6 million physician office visits, 800,000 emergency room visits, and more than 500,000 hospitalizations, and the placement of nearly 180,000 people into nursing homes. The direct care expenditures for osteoporotic fractures alone range from $12 to $18 billion each year (measured in 2002 dollars) (Ref. 4). The indirect health costs, such as pain, suffering, and lost mobility, of osteoporosis are also large. Average calcium and vitamin D intakes are below recommended levels for many consumers (Refs. 4, 49, and 50). Even though many consumers are not achieving recommended intakes of calcium, producers have rarely placed the calcium-osteoporosis health claim on products that qualified for the claim. FDA's 2001 FLAPS (the most recently available data) showed only 1 out of the 87 shelf-stable juice products surveyed, a fortified orange juice, bearing the calcium osteoporosis health claim. None of the 10 milk products surveyed bore the claim (Ref. 51).

FDA has identified four regulatory options for this proposed rule: (1) Take no new regulatory action; (2) reduce the required language in the existing calcium-osteoporosis health claim; (3) expand the existing calcium-osteoporosis health claim to include vitamin D; or (4) reduce the required language in the existing calcium osteoporosis health claim and include vitamin D as an option to the claim, as described in this proposed rule.

This proposed rule, if finalized as proposed, would require that any food manufacturers wishing their products' labels to make the calcium, or calcium and vitamin D, and osteoporosis health claim be redesigned. Labels must be redesigned in order for a food to carry the health claim since information on populations at particular risk for osteoporosis would no longer be required or allowed for the claim (see § 101.72(c)(2)(A) and (c)(2)(B)).

Products that wish to continue making a calcium health claim would not need to reformulate their products under the proposed rule. The nature of the food eligible to make a calcium health claim remains food that meets or exceeds a “high” level of calcium (as defined in § 101.54(b)). Manufacturers wishing to take advantage of the expanded calcium and vitamin D claim may voluntarily choose to reformulate their products. If some producers choose to reformulate their products to take advantage of the calcium and vitamin D health claim, they reveal that they expect the private benefit that the claims give them to exceed the expense of making the claims. If this is not the case, no producer will voluntarily choose to use the claims. Likewise, consumers who choose to purchase the products with the amended health claims reveal that they value the products more highly than other alternatives, including not purchasing the products.

We consider five potential effects in estimating the relative public health benefits of the options: (1) The extent to which the option encourages producers to use the health claims on their food labels; (2) the extent to which the option encourages producers to reformulate their products to make the health claims; (3) the extent to which the option provides information to consumers; (4) potential risk-risk tradeoffs (where the action taken to reduce the risk posed by one hazard causes an increase in the risk posed by another hazard) with each option; and (5) the availability of information on the relationship between osteoporosis and calcium and vitamin D to consumers who do not consume dairy products.

There are four likely responses to this proposal from producers: (1) Make no changes (i.e., continue not making the calcium or calcium and vitamin D health claim; (2) create new product labels to continue making the calcium health claim (for products already making the existing claim); (3) add the health claims to their products that qualify for the health claims (increase usage of the claim due to the new required wording); and (4) reformulate their products (by fortifying with calcium or vitamin D, for example) to qualify for the health claims.

Several factors affect whether producers choose to use health claims, including the flexibility of the health claims and how appealing the health claims are to consumers. Revising the existing calcium osteoporosis health claim language to make it shorter will make it more appealing to put the health claims on labels. Package space is limited, so more flexible and shorter claims are easier to use. Also, Wansink, et al. (2004) found that shorter health claims on the front of the package led to more favorable beliefs about the product and a more positive image of the product among consumers (Ref. 52).

Approving a calcium, vitamin D, and osteoporosis health claim should encourage the manufacturers of foods that are eligible for fortification with vitamin D to do so because they will be able to publicize the relationship between vitamin D, calcium, and osteoporosis on their labels. If producers fortify more products with vitamin D, consumers can get more vitamin D in their diet without making changes in their dietary choices.

Providing information about the relationship between calcium, vitamin D, and osteoporosis on food packages provides a number of benefits to consumers, including: (1) Informing them about the nutrient-disease relationship; (2) helping them identify products that are high in calcium and vitamin D; and (3) helping them make dietary choices that reduce their risk of osteoporosis. The extent to which consumers realize these benefits will depend on the consumers knowledge of the relationship between calcium, vitamin D, and bone health; how many products bear the calcium or calcium and vitamin D health claims; how many consumers read the health claims; and how much they change their behavior to include such products in their diets. There is evidence that consumers who read nutrition information on packages eat healthier diets (Refs. 53 and 54). However, there is a great deal of uncertainty about how much consumers change their behavior in response to label information.

A potential concern is that allowing these osteoporosis health claims on juice drinks will result in consumers switching away from milk to juice drinks, which are higher in calories, for dietary sources of calcium and vitamin D. Table 1 of this document presents the caloric and nutrient profile of non-fat and low-fat milk products and an orange juice drink product as reported in the USDA National Nutrient Database for Standard Reference. Orange juice drinks are higher in calories and contain less of some important nutrients than either non-fat or low-fat milk (table 1 of this document).

The likelihood of consumers switching from non-fat or low-fat milk or to higher caloric juice drinks because of this rule is expected to be small because non-fat and low-fat milk and juice drinks that are eligible can already make the existing calcium and osteoporosis health claim. Permitting the same set of products to make the proposed, simpler calcium and osteoporosis health claim should not change the relative appeal of the claim to producers of one type of beverage over another. The allowance of the new calcium and vitamin D osteoporosis health claim could expand the set of products making an osteoporosis claim; however, the relative appeal of the new claim (calcium and vitamin D) to producers of non-fat and low-fat milk and juice drinks should be similar to the appeal of the existing calcium osteoporosis claim.

There is little evidence to support that consumers would switch from non-fat or low-fat milk to juice drinks as a result of this proposed rule. As stated in the Surgeon General's report on bone health and osteoporosis, consuming adequate levels of calcium and vitamin D throughout life are critically important to an individual's bone health. However, the report's review of national surveys suggests that the average calcium intake of individuals is far below the levels recommended for optimal bone health. One reason cited by the report for these low levels of calcium intake relates to current lifestyle and food preferences, which have resulted in reduced intake of dairy products and other naturally occurring calcium-rich foods. The report also posits that for some individuals lactose intolerance 3 may also play a role in not consuming adequate levels of calcium. Given this information on the current preference and tolerance for dairy products, expanding the calcium and osteoporosis health claim to include vitamin D as a result of this proposed rule should only lead to an increase in the overall consumption of these essential, under consumed nutrients.

In addition, according to the American Beverage Association, U.S. sales of calcium-fortified orange juice has grown dramatically over recent years, reaching nearly $1 billion in 2003 (Ref. 55), while overall sales of juice have not grown. Therefore, FDA expects that the nutritional profile of diets would most likely improve as a consequence of changes in consumption resulting from this proposed rule. Switching from unfortified to fortified juices would increase needed consumption of calcium and vitamin D.

The simplification of the current health claim for calcium and osteoporosis, along with the additional proposed health claim for calcium, vitamin D, and osteoporosis should increase and expand the current usage of the health claim and therefore improve the U.S. population's intake of these two important nutrients. Therefore, all of the options considered below would improve public health relative to the baseline of taking no new regulatory action. In our analysis of the benefits and costs of the options, we compare the benefits and costs of each option with each other option based on their relative effects on consumer and producer behavior.

This option would result in no change to the current situation. This is the baseline for comparison of options and entails no costs or benefits.

Compared with Option 1, this option would increase the appeal of the claim for producers, increase the use of the claim on products, and thereby provide consumers with more information on the calcium and osteoporosis diet-disease relationship. It could encourage more reformulation of products to fortify with calcium than has occurred with the existing claim. Like Option 1, this option provides consumers with no information about the relationship of vitamin D to osteoporosis.

With this option, manufacturers of some products making the current calcium and osteoporosis health claim may have to re-label their products to reflect the updated wording provided by the proposed claim. The potential costs associated with a required label change will vary depending on when the new effective compliance date is established. Table 2 of this document shows the possible range of costs by product type of having to re-label to be in compliance with the revised calcium and osteoporosis health claim. The product re-labeling costs were estimated using the FDA Labeling Cost Model (Ref. 56). The costs of re-labeling included are administrative, graphic, prepress, engraving, and inventory costs. Re-labeling costs are shown for both a 12 month and 24 month compliance period.

Failing to shorten the existing calcium and osteoporosis health claim will not make the health claim as appealing to producers and consumers as Option 2, leading to less claim use and reformulation and less information provided to consumers than Option 2. This option would provide consumers with more information on vitamin D than Option 2, should producers decide to voluntarily re-label and/or reformulate their products to make use of the added vitamin D language.

Like Option 2, this option would increase the appeal of the calcium and osteoporosis health claim for producers and thereby provide consumers with more information on the calcium and osteoporosis diet-disease relationship. Also like Option 2, producers of products with existing calcium and osteoporosis health claim labeling will have to revise their labeling in order to comply with the revised claim language. Like Option 3, this option would provide consumers with more information on vitamin D than Option 2 because the new, simplified calcium and osteoporosis health claim can now contain information about vitamin D as well. It could also encourage more reformulation of products to fortify with vitamin D than would Option 2 and as many products to fortify with calcium as Option 2.

FDA is unable to quantify the benefits of this proposed rule due to uncertainty about the degrees of changes in consumer and producer behavior. However according to information compiled in the Surgeon General's report on bone health and osteoporosis, there are about 1.5 million osteoporotic fractures in the United States each year that carry annual direct care expenditures of $12 to $18 billion per year (2002 dollars). These fractures cause more than half a million hospitalizations, over 800,000 emergency room encounters, more than 2.6 million physician office visits, and the placement of nearly 180,000 individuals into nursing homes annually (Ref. 4). The direct costs of other complications from osteoporosis, and the indirect costs of these fractures and other osteoporotic ailments (e.g., the value of functional disability to the patient, the value of the pain and suffering to the patient, the costs experienced by the care giver) if calculated, would add substantially to the annual costs of this disease. Any increase in calcium and vitamin D intake by consumers insufficient in these nutrients as a result of this proposed rule could possibly lower the incidence of osteoporosis and therefore the annual costs associated with the disease.

Table 3 of this document provides a summary of the effects of the rule, and which options create the smallest and largest behavior changes for consumers and producers. All options should produce positive net benefits, with the largest net benefit arising from Option 4, the proposed rule. With Option 4, the largest number of products and labels would change, leading to the largest reduction in the risk of osteoporosis.

FDA has examined the economic implications of this proposed rule as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities consistent with statutory objectives. FDA does not believe that this proposed rule will have a significant economic impact on a substantial number of small entities because the only mandatory costs of this rule are the costs to update the current wording of the calcium osteoporosis health claim for manufacturers of products that currently make the claim and wish to continue doing so. Also previously mentioned, FDA's 2001 Food Labeling and Product Survey showed only 1 out of 87 shelf-stable juice products surveyed bore the current calcium and osteoporosis health claim while none of the 10 milk products surveyed bore the claim. This implies that not many products eligible to bear the current claim would need to be re-labeled as a result of this proposed rule.

In addition, FDA establishes uniform compliance dates for final food labeling regulations in 2-year intervals. Therefore, companies whose products currently make the calcium and osteoporosis health claim and wish to continue doing so will have between 1 and 2 years to use existing label inventory and expense the costs of designing revised labeling. FDA estimates that on average, the cost to re-label a product according to the revised health claim language will be $7,900 to $16,600 per product if the compliance period is 12 months; and $6,100 to $13,600 per product if the compliance period is 24 months. FDA requests comment on whether this rule will have a significant impact on a substantial number of small entities. Manufacturers that wish to begin using the revised calcium and osteoporosis health claim or the new calcium, vitamin D, and osteoporosis health claim will only do so if the benefits of labeling their products to inform consumers of the claim outweigh the costs of doing so.

The agency has determined under 21 CFR 25.32(p) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

FDA concludes that the labeling provisions of this proposed rule are not subject to review by the Office of Management and Budget because they do not constitute a “collection of information” under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). Rather the food labeling health claim on the association between calcium only, or calcium and vitamin D, and reduced risk osteoporosis is a “public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public” (5 CFR 1320.3(c)(2)).

FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule, if finalized as proposed, has a preemptive effect on State law. Section 4(a) of the Executive order requires agencies to “construe * * * a Federal Statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” Section 403A of the act (21 U.S.C. 343-1) is an express preemption provision. Section 403A(a)(5) of the act (21 U.S.C. 343-1(a)(5)) provides that: “***no State or political subdivision of a State may directly or indirectly establish under any authority or continue in effect as to any food in interstate commerce—***(5) any requirement respecting any claim of the type described in section 403(r)(1) of the act made in the label or labeling of food that is not identical to the requirement of section 403(r) * * *.” Currently, this provision operates to preempt States from imposing health claim labeling requirements concerning calcium and vitamin D and reduced risk of osteoporosis because no such requirements had been imposed by FDA under section 403(r) of the act. This proposed rule, if finalized as proposed, would amend existing food labeling regulations to add vitamin D to the authorized health claim for calcium and a reduced risk of osteoporosis and would simplify the claim language. Although any final rule would have a preemptive effect in that it would preclude States from promulgating any health claim labeling requirements for calcium or calcium and vitamin D and a reduced risk of osteoporosis that are not identical to those that would be required by a final rule, this preemptive effect is consistent with what Congress set forth in section 403A of the act. Section 403A(a)(5) of the act displaces both state legislative requirements and state common law duties. Medtronic v. Lohr , 518 U.S. 470, 503 (1996) (Breyer, J., concurring in part and concurring in judgment); id. at 510 (O'Connor, J., joined by Rehnquist, C.J., Scalia, J., and Thomas, J., concurring in part and dissenting in part); Cipollone v. Liggett Group, Inc. , 505 U.S. 504, 521 (1992) (plurality opinion); id. at 548-49 (Scalia, J., joined by Thomas, J., concurring in judgment in part and dissenting in part).

FDA believes that the preemptive effect of this proposed rule, if finalized as proposed, is consistent with Executive Order 13132. Section 4(e) of the Executive order provides that “when an agency proposes to act through adjudication or rulemaking to preempt State law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.” FDA provided the States with an opportunity for appropriate participation in this rulemaking when it sought input from all stakeholders on February 17, 2006, when FDA's Division of Federal and State Relations provided notice via fax and e-mail transmission to State health commissioners, State agriculture commissioners, food program directors, and drug program directors as well as FDA field personnel of FDA's potential amendment to the health claim regulation authorizing health claims for calcium and osteoporosis (§ 101.72). The notice provided the States with further opportunity for input on the rule. It advised the States of FDA's possible action and encouraged the States and local governments to review the notice and to provide any comments to the docket (Docket No. 2004P-0294), until March 2, 2006. FDA received no comments in response to the notice. FDA is also providing an opportunity for State and local officials to comment on this proposed rule.

In conclusion, the agency has determined that the preemptive effects of this proposed rule are consistent with Executive Order 13132.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The following references have been placed on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20857, and may be seen by interested persons between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the Web site addresses, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register .)

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of the Food and Drugs, and redelegated to the Deputy Director for Regulatory Affairs, it is proposed that 21 CFR part 101 be amended as follows:

1. The authority citation for 21 CFR part 101 continues to read as follows:

2. Section 101.72 is revised to read as follows:

(a) Relationship between calcium, vitamin D, and osteoporosis . An inadequate intake of calcium or calcium and vitamin D contributes to low peak bone mass, which has been identified as one of many risk factors in the development of osteoporosis. Peak bone mass is the total quantity of bone present at maturity, and experts believe that it has the greatest bearing on whether a person will be at risk of developing osteoporosis and related bone fractures later in life. Another factor that influences total bone mass and susceptibility to osteoporosis is the rate of bone loss after skeletal maturity. Vitamin D is required for normal absorption of calcium and to prevent the occurrence of high serum parathyroid hormone (PTH) concentration, which stimulates mobilization of calcium from the skeleton and can lower bone mass. Calcium, along with vitamin D and several other nutrients, is required for normal bone mineralization. While vitamin D is required for optimal bone mineralization, it is more effective when calcium intake is adequate. An adequate intake of calcium and vitamin D is thought to exert a positive effect during adolescence and early adulthood in optimizing the amount of bone that is laid down. However, the upper limit of peak bone mass is genetically determined. The mechanism through which adequate intakes of calcium and vitamin D and optimal peak bone mass reduce the risk of osteoporosis is thought to be as follows. All persons lose bone with age. Hence, those with higher bone mass at maturity take longer to reach the critically reduced mass at which bones can fracture easily. The rate of bone loss after skeletal maturity also influences the amount of bone present at old age and can influence an individual's risk of developing osteoporosis. Maintenance of adequate intakes of calcium and vitamin D later in life is thought to be important in reducing the rate of bone loss particularly in the elderly and in women during the first decade following menopause, but a significant protective effect is also seen among men and younger women.

(b) Significance of calcium or calcium and vitamin D . Adequate calcium intake, or adequate calcium and vitamin D intake, is not the only recognized risk factor in the development of osteoporosis, which is a multifactorial bone disease. Maintenance of adequate calcium and vitamin D intakes throughout life is necessary to achieve optimal peak bone mass and to reduce the risk of osteoporosis in later life. However, vitamin D is most effective in this regard when calcium intake is adequate. Increasing intake of calcium has been shown to have beneficial effects on bone health independent of dietary vitamin D.

(c) Requirements . (1) All requirements set forth in § 101.14 shall be met.

(2) Specific requirements —(i) Nature of the claim . A health claim associating calcium or, when appropriate, calcium and vitamin D with a reduced risk of osteoporosis may be made on the label or labeling of a food described in paragraphs (c)(2)(ii) and, (d)(1) of this section, provided that:

(A) The claim makes clear the importance of adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, throughout life, in a healthful diet along with physical activity, are essential to reduce osteoporosis risk. The claim does not imply that adequate calcium intake, or when appropriate, adequate calcium and vitamin D intake, is the only recognized risk factor for the development of osteoporosis;

(B) The claim does not attribute any degree of reduction in risk of osteoporosis to maintaining an adequate dietary calcium intake, or when appropriate, an adequate dietary calcium and vitamin D intake, throughout life.

(ii) Nature of the food . (A) The food shall meet or exceed the requirements for a “high” level of calcium as defined in § 101.54(b);

(B) The calcium content of the product shall be assimilable;

(C) Dietary supplements shall meet the United States Pharmacopeia (U.S.P.) standards for disintegration and dissolution applicable to their component calcium salts, except that dietary supplements for which no U.S.P. standards exist shall exhibit appropriate assimilability under the conditions of use stated on the product label;

(D) A food or total daily recommended supplement intake shall not contain more phosphorus than calcium on a weight per weight basis.

(d) Optional information . (1) The claim may include the term “vitamin D” if the food meets or exceeds the requirements for a “high” level of vitamin D as defined in § 101.54(b);

(2) The claim may include information from paragraphs (a) and (b) of this section.

(3) The claim may include information on the number of people in the United States who have osteoporosis or low bone density. The sources of this information must be identified, and it must be current information from the National Center for Health Statistics, the National Institutes of Health, or the National Osteoporosis Foundation.

(4) The claim may state that the role of adequate calcium intake, or when appropriate, the role of adequate calcium and vitamin D intake, throughout life is linked to reduced risk of osteoporosis through the mechanism of optimizing peak bone mass during adolescence and early adulthood. The phrase “build and maintain good bone health” may be used to convey the concept of optimizing peak bone mass. When reference is made to persons with a family history of the disease, menopausal women, and elderly men and women, the claim may also state that adequate intake of calcium or adequate intake of calcium and vitamin D, if applicable, is linked to reduced risk of osteoporosis through the mechanism of slowing the rate of bone loss.

(e) Model health claims . The following model health claims may be used in food labeling to describe the relationship between calcium and osteoporosis:

(f) Model additional health claims for calcium and vitamin D . The following model health claims may be used in food labeling to describe the relationship between calcium, vitamin D, and osteoporosis:

In the Federal Register of December 21, 1995, FDA published a proposed rule entitled “Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims” (60 FR 66206), the 1995 proposal, to amend its regulations on health claims and nutrient content claims to provide more flexibility in the use of these claims on food products, and to amend specific requirements to certain individual health claims. FDA took this action in response to citizen petitions submitted by the National Food Processors Association (NFPA) (Docket No. 1994P-0390) and the American Bakers Association (ABA) (Docket No. 1995P-0241). The agency has extended or reopened the comment period for the 1995 proposal four times in response to requests by stakeholders and other FDA initiatives and developments. The most recent reopening of the comment period was announced in the Federal Register of May 4, 2004 (69 FR 24541), and the comment period was open until July 6, 2004.

On July 12, 2004, the agency received a health claim petition submitted by The Beverage Institute for Health and Wellness requesting that the agency amend the calcium and osteoporosis health claim to, among other things, simplify the language used in the claim. In response to this health claim petition, FDA is publishing elsewhere in this issue of the Federal Register a proposed rule to, among other things, simplify the language used in the calcium and osteoporosis health claim. Accordingly, the agency is withdrawing certain proposed amendments to the specific requirements in the calcium and osteoporosis health claim.

In the 1995 proposal, FDA proposed to simplify § 101.72(c)(2)(i)(A) by limiting the requirement to a balanced statement that reflects the importance of the essential nutrient calcium over a lifetime in a healthful diet to reduce osteoporosis risk, but that does not imply that calcium is the only risk factor for the development of osteoporosis, and to eliminate the provision in § 101.72(c)(2)(i)(A) that the specific risk factors, including sex, race, age, and the need for an adequate level of exercise be stated in any claim. Elsewhere in this issue of the Federal Register , FDA is proposing alternative amendments to § 101.72(c)(2)(i)(A). Therefore, FDA is withdrawing this proposed amendment of the 1995 proposal.

In the 1995 proposal, FDA proposed to revise § 101.72(c)(2)(i)(B) by removing the requirement to identify by race or ethnicity those populations at particular risk for the development of osteoporosis, but to retain identification of teen and young women, irrespective of race or ethnicity, as the focus of the claim. Elsewhere in this issue of the Federal Register , FDA is proposing alternative amendments to § 101.72(c)(2)(i)(B). Therefore, FDA is withdrawing this proposed amendment of the 1995 proposal.

In the 1995 proposal, FDA proposed to increase the amount of calcium present in a food that triggers the requirement in § 101.72(c)(2)(i)(E) that the claim include a statement that reflects the limit of the benefits derived from dietary calcium intake. Elsewhere in this issue of the Federal Register , FDA is proposing alternative amendments to § 101.72(c)(2)(i)(E). Therefore, FDA is withdrawing this proposed amendment of the 1995 proposal.

Elsewhere in this issue of the Federal Register , FDA is publishing a proposed rule to amend § 101.72 to, among other things: (1) Eliminate the requirement in § 101.72(c)(2)(i)(A) that the claim list sex, race, and age as specific risk factors for the development of osteoporosis; (2) eliminate the requirement in § 101.72(c)(2)(i)(B) that the claim does not state or imply that the risk of osteoporosis is equally applicable to the general U.S. population, and that the claim identify the populations at particular risk for the development of osteoporosis; and (3) eliminate the requirement in § 101.72(c)(2)(i)(E) that the claim include a statement that reflects the limit of the benefits derived from dietary calcium intake, when the level of calcium in the food exceeds a set threshold level.

Comments specific to the proposed amendments in § 101.72(c)(2)(i)(A), (B), and (E) that were submitted in response to the 1995 proposal were considered in the development of the proposed rule that responds to the health claim petition submitted by The Beverage Institute for Health and Wellness.

Authority: Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, the proposed rule published on December 21, 1995 (60 FR 66206), is withdrawn in part for § 101.72(c)(i)(A), (B), and (E).

Regulatory History

On August 1, 2006, the Coast Guard published a notice of proposed rulemaking (NPRM) (71 FR 43402) to establish permanent safety zones throughout the Great Lakes which would restrict vessels from portions of the Great Lakes during live-fire gun exercises that would be conducted by Coast Guard cutters and small boats. The initial comment period for the NPRM ended on August 31, 2006. In response to public requests, the Coast Guard re-opened the comment period (71 FR 53629, September 12, 2006) from September 12, 2006 to November 13, 2006, in order to provide the public more time to submit comments and recommendations. On September 19 and 27, 2006, the Coast Guard published brief documents announcing the dates and other information on public meetings regarding the NPRM and the gunnery exercises. (71 FR 54792, 56420).

On October 12, 2006, the Coast Guard announced the addition of three more public meetings and again stated that more detailed information related to the meetings would be published at a later date. (71 FR 60094). On October 23, the Coast Guard published a document containing detailed information about five additional public meetings. (71 FR 62075).

Thirty-four safety zones were to be located throughout the Great Lakes in order to accommodate 56 separate Coast Guard units. The proposed safety zones were all located at least three nautical miles from the shoreline.

The Coast Guard proposed to establish permanent zones on the Great Lakes to provide the public with more notice and predictability when conducting infrequent periodic training exercises of brief duration, and to give the public an opportunity to comment on the proposals. The proposed safety zones would have appeared on National Oceanographic and Atmospheric Administration nautical charts, which would have provided a permanent reference for mariners.

The proposed safety zones would have been utilized only upon notice by the cognizant Captain of the Port for the area involved in the exercise. Under the procedure outlined in the NPRM, the cognizant Captain of the Port would have issued notice of the enforcement of a live-fire exercise safety zone by all appropriate means to effect the widest publicity among the affected segments of the public including publication in the Federal Register as practicable, in accordance with 33 CFR 165.7(a). Such means of notification would have included, but not been limited to, Broadcast Notice to Mariners or Local Notice to Mariners before, during, and at the conclusion of training exercises.

The coordinates of the proposed safety zones were published on August 1, 2006 at 71 FR 43402. All coordinates used to determine the zones were based upon North American Datum 1983 (NAD 83).

The Coast Guard is withdrawing the NPRM published on August 1, 2006 concerning the establishment of safety zones throughout the Great Lakes, but will examine options for future consideration which may include a new NPRM. The Coast Guard will reevaluate the proposal in light of issues raised in the comments the Coast Guard received during the course of this rulemaking. Whatever option the Coast Guard pursues, it intends to address the concerns of the Great Lakes community and to work with the region's stakeholders to develop an acceptable solution that meets the readiness needs of Coast Guard Forces and addresses the public's concerns.

The Coast Guard received over 900 comments regarding this NPRM. The Coast Guard received comments from Members of Congress, state and local government representatives, environmentalists, recreational boaters, commercial users, Native American tribes, local businesses, and members of the general public in the Great Lakes region.

Several commenters unconditionally supported the Coast Guard's proposal and recognized the Coast Guard's need to be trained in order to carry out its law enforcement and homeland security missions. Several other commenters supported the Coast Guard's proposal but like many commenters raised concerns about the number, size, and location of the proposed safety zones and whether they would impede recreational and commercial activity, including tourism. Some stated that the water training areas would negatively impact the economy, and some ferry operators commented that the locations of the areas would negatively impact their operations.

Commenters also expressed concerns related to safety and notification issues surrounding the establishment of the water training areas. For example, there were questions on the distance that bullets can travel if they ricochet off the surface of the water and how far they could travel generally. Notification questions included how small craft and vessels without radios would be notified that a live-fire exercise was being conducted in their area. Some people stated that the 2 hour broadcast notice to mariners was insufficient and suggested additional notification procedures, including the use of local media or announcements on the emergency broadcast system. While some commenters suggested that notification begin two weeks before the scheduled exercise, others requested that training be limited to particular days of the week and seasons of the year. In particular, commenters requested that the training schedule avoid peak boating season to accommodate safety and notification concerns.

Many commenters mentioned environmental concerns, including the potential for lead to find its way into their drinking water. Native American tribes, along with other groups, also expressed concerns regarding subsistence fishing and the impact of lead on the food supply.

Other environmental comments related to the Preliminary Health Risk Assessment. 1 Based upon standard risk evaluation procedures and “realistic worst case” assumptions, the Risk Assessment concluded that the proposed training would result in no elevated risks for the Great Lakes/freshwater, estuarine/Chesapeake Bay, and riverine systems scenarios. Commenters raised concerns, among others that the Risk Assessment did not consider current levels of contamination or contemplate potential cumulative effects beyond 5 years.

Some commenters raised concerns over the Rush-Bagot Agreement of 1817 that limits naval forces on the Great Lakes, and the impact of the training exercises on the relationship between the United States and Canada. Other commenters expressed general concern over the perceived militarization of the Great Lakes.

Commenters suggested a variety of alternatives. Some commenters suggested limiting the number of zones and reducing their size. Other suggestions included using “green” ammunition, simulators and/or lasers, and conducting the training in areas other than the Great Lakes.

In light of these comments and input received during the public meetings, the Coast Guard is withdrawing the current NRPM. The Coast Guard will not conduct further gunnery training on the Great Lakes to satisfy non-emergency training requirements unless the Coast Guard publishes notice of its proposed action, allows the public an opportunity to comment, and publishes a final rule. A terrorist attack or other emergency may alter these plans. The Coast Guard will ensure that any live-fire training is conducted responsibly, safely, and in accordance with applicable legal requirements.

The threat against our Nation remains very real, and vulnerabilities within the Great Lakes system are extensive, diverse, and significant. The Coast Guard is mandated to provide for the safety and security of the more than 30 million people in the Great Lakes Basin, as well as the 11 major ports, 13 nuclear power plants, 348 regulated terminals and facilities, 22 high capacity passenger vessels and ferries, and the hundreds of locks, dams, bridges and other critical infrastructure that make up the Great Lakes system. The Coast Guard is also responsible for the safety and security of several thousand annual Great Lakes commercial vessel transits.

The Coast Guard must be prepared to counter overseas, cross-border, or domestic threats. This includes protecting the citizens of the Great Lakes as well as vessels, ports, waterways and critical infrastructure in the Great Lakes. The Coast Guard must be trained and prepared to meet all threats and all hazards. In order to be proficient, the Coast Guard must train in the maritime environment in which it operates. Operating in the maritime environment is inherently different from land operations, and Coast Guard personnel must be able to shoot safely and effectively from vessels at moving targets in the water.

While the Coast Guard must be ready to confront threats to homeland security originating in the maritime domain, training in the environment must be conducted with due regard for public safety and in a manner that is protective of human health and the environment.

To properly consider the many equities involved, the Coast Guard is withdrawing the NPRM. The Coast Guard is analyzing temporary options to ensure that Coast Guard boat crews obtain training outside the Great Lakes that they require to retain current gunnery qualifications. Maintaining these qualifications is imperative to the Coast Guard mission of providing adequate levels of maritime security in the Great Lakes. The Coast Guard will evaluate all available options including whether to issue a new NPRM prior to conducting non-emergency training exercises on the Great Lakes.

This action is taken under the authority of 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, and 160.5; Public Law 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.