The Occupational Safety and Health Administration (OSHA) is no stranger to pharmacists, drug wholesalers, and pharmaceutical manufacturers. At one time or another, many have found OSHA inspectors at their doorsteps unannounced and warrantless. In just eight years, OSHA's clashes with small business owners have made it one of the most controversial federal regulatory agencies. Ironically, passage of the Occupational Safety and Health Act of 1970 (the Act") was greeted warmly by millions who agreed with its purposes: what could be less objectionable than protecting American workers in their workplaces? Subsequent events suggested that what appeared to be the road to workplace safety, freely paved with the best of intentions, instead was going in another direction and was subject to stiff tolls. Many businessmen felt that OSHA regulations, which bear the force of law, were onerous and outdated. Others felt tha t OSHA inspections were nitpicking, harsh, and more concerned with punishment than with correction of health hazards. Workers and their representatives critiziced OSHA for concen tra ting on trivia while ignoring serious workplace health hazards. And Congress began to consider reforming OSHA's methods of operation. It is fair to say that OSHA and the Act that created it may have engendered the most severe criticism of any piece of federal legislation in recent history. Court attacks mounted along with criticism and controversy. Initial court challenges charged that the Act unconstitutionally imposed automatic fines; that the fines were
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The Itnpact of the Barlow's Decision By LLOYD A. FOX and IRA J. SMOTHERMAN JR.
26
Lloyd A. Fox, a pharmacist-attorney, is a partner in the law firm of Stokes and Shapiro, 2300 National Bank Tower, Atlanta, GA 30303, and has published many articles in the area of pharmacy law. Ira J. Smotherman Jr. is also a partner in the law firm of Stokes and Shapiro. He practices law in the OSHA area and was cocounsel on the Atlas Roofing Supreme Court OSHA constitutional test case.
American Pharmacy VoI.NS19, No.2, Feb.1979/82
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in the nature of criminal penalties; and that the Act violated the Seventh Amendment right to a jury trial. None of these arguments swayed the United States Supreme Court, which affirmed the constitutionality of the Act. 1 Several other cases were winding their way through the lower federal courts at that time. These cases arose when businessmen refused to allow OSHA inspectors to inspect their business premises without a search warrant.
The Fourth Amendment and the Barlow's Decision The Right to Inspect. The Fourth Amendment protects citizens against unreasonable searches and seizures by the federal government. In order to conduct a search, police and other public authorities must persuade a judge or magistrate that there is "probable cause" that a law has been violated. In one of the OSHA cases, a small construction contractor in Idaho refused to allow an OSHA inspector on his business premises. OSHA demanded a court order allowing the inspection. The federal court instead ruled that the Act was unconstitutional because it did not require search warrants prior to inspections. 2 Other courts followed the same reasoning and required OSHA to obtain warrants if the employers objected to OSHA inspections. OSHA appealed the Idaho decision, and on May 23, 1978, in Marshall v. Barlow's, Inc., the Supreme Court declared that OSHA inspections conducted without search warrants violate the Fourth Amendment unless the owner of the business consents to the inspection. If the owner refuses consent, the Court ruled that the Fourth Amendment requires an OSHA inspector to obtain a search warrant based on probable cause. The Supreme Court adopted a vague but broad standard of probable cause. Specific evidence of an existing violation obviously satisfies the criteria, but the court specifically rejected the notion that the inspector must present evidence
-
American Pharmacy VoI.NS19. No.2. Feb.1979/83
of this kind. Probable cause could be shown by evidence that "reasonable legislative or administrative standards for conducting an ... inspection are satisfied with respect to a particular [establishment]." What standards are "reasonable" for issuing a search warrant is anyone's guess, but according to the Court, statements that OSHA has an inspection program designed to assure maximum compliance, and that a particular business is within the program's jurisdiction, are insufficient. Allegations must be supported by facts, and presumably the judicial officer must decide on the reasonableness of the specific standards or program. Of course, the judge's decision usually can (and will) be reached without consid-
'The warrant procedure raises problems for pharmacists who attempt to decide in advance how to react to an inspection request . ... '
eration of arguments from the employer contesting the inspection. The warrant procedure described by the Supreme Court raises problems for pharmacists and others who attempt to decide in advance how to react to an inspection request and whether to require a warrant. Depending on lower court interpretations, OSHA may have no trouble devising standards that will virtually guarantee a warrant for any inspection. A Massachusetts case is considering a challenge to OSHA's contention that selection of business for inspection under its "worst first" plan for increased inspection of hazardous industries satisfies the Supreme Court's "probable cause" test. 4 (Just prior to publication, this case was dismissed as being "moot" because OSHA surrendered the warrant.)
The Plain View Doctrine. While it is now clear that an OSHA inspector can be required to obtain a search warrant if denied permission to inspect, several other legal principles may interfere with the exercise of individual rights. If the business premises are not owned and occupied solely by the business to be inspected, OSHA may seek consent from someone else with ownership or possession of the premises, such as a landlord or tenant. If this other party gives consent, the consent will probably be valid; even if it is not, the businessman seeking to block the inspection will probably have to go to court immediately to seek a temporary restraining order to keep the inspector out-an expensive and time-consuming process. The OSHA inspector also has a right, under general Fourth Amendment principles, to inspect and investigate any conditions which appear to violate the Act and which are in "plain view" while he or she is standing in a public area such as the public portion of retail business premises. Community pharmacies and hospitals could be subject to application of the plain view doctrine, and pharmacists should be aware of its ramifications. Further, the plain view doctrine allows charges based on violations detected during such a search, even when such violations were not originally in plain view. The plain view doctrine also can be combined with the powers granted by a search warrant. The Supreme Court stated that the search permitted by a warrant would be subject, as in other cases, to the scope of the warrant. Thus if an inspector obtained a warrant to search the offices of an industrial business, the search would be limited to that specific area and could not be expanded to an adjacent warehouse or factory without consent. However, if the inspector, while in the offices, noticed a violation in an adjacent area, he or she could legally inspect and investigate this violation (even to the point of questioning other workers on any part of the premises) because the
27
violation wa's in plain view from an area in which the inspector had a right to be. The inspector could not use such a warrant as a springboard to inspect the entire premises, since the entire premises were not particularized in the warrant.
Reaction to the Barlow's Decision Although the Barlow's decision left a number of questions in its wake, the reaction of business, labor, and government followed predictable lines. In the decision, the Supreme Court stated that it expected the great majority of businessmen to consent to warrantless inspections. As can be expected, OSHA announced that it would continue its present policy of not obtaining warrants unless refused entry. The Environmen tal Protection Agency also stated its expectation that its inspectors would not generally be required to obtain warrants. At least initially, the expectations of the Supreme Court and the governmental agencies have been fulfilled. As of July 7, 1978, only 291, or 1.5 percent, of the 19,216 employers inspected since the Barlow's decision on May 23 had demanded search warrants. S While this continued vol.untary compliance must be warmly received by labor groups which decried the Supreme Court's decision, the anti-OSHA forces, which generally greeted the Barlow's decision favorably, have announced plans to inform employers of their right to demand warrants and to urge them to exercise these rights.
The Practical Side While the Barlow's ruling is an important reaffirmation of Fourth Amendment rights, particularly for business, a businessman must take several items into consideration before refusing admission to an OSHA inspector or another federal or state inspector. Clarification of the Supreme Court's decision is several years away. The businessman who is considering refusal of per-
28
mission to inspect will have to make very important decisions with the OSHA inspector on the doorstep, and without knowing how the ambiguities in the original decision will be resolved. The businessman must evaluate the benefits, risks, and alternatives and develop a strategy in keeping with the perceived best interests of the business. Since forthcoming court decisions may make it very easy for OSHA to obtain a search warrant for any inspection, the businessman is faced with the possibility of simply angering the OSHA inspector by asking for a warrant. Contesting the validity of the basis for the warrant may be unsuccessful and may anger the OSHA officials even more. The businessman may be considered uncoopera tive" and likely to be hiding something. While OSHA officials and legal counsel have stated categorically that inspectors will be courteous when denied permission to inspect, and will obtain warrants quickly, inspectors are subject to the same psychological pressures as other persons, and the possibility of a harsh reaction by an inspector must be considered in the businessman's determination of what course to follow. If a businessman deni~s permission for an inspection, the OSHA
If
officials will attempt, through their attorneys, to secure a warrant. This procedure is done ex parte, that is, without the presence of the businessman or attorney. The attorney for OSHA simply goes to the federal magistrate alone or with the OSHA inspector and requests the magistrate to issue a warrant. The application for the warrant is supported by an affidavit of the inspector or of another person who has knowledge of the complaint or other facts that OSI-IA will cite as justifying the warrant. Ordinarily, unless the businessman has put the magistrate on notice of a possible application by OSHA for a warrant and has specifically asked for a hearing, the magistrate will make an immediate decision either to issue or not to issue the warrant. If a warrant is issued, the businessman's recourse is to refuse to permit the inspection when the inspector arrives with the warrant. If this step is taken the businessman should immediately file a motion with either the federal magistrate or the federal court to quash (nullify) the warrant as invalid or should file suit to enjoin the inspection pursuant to the warrant, on the grounds that the warrant is invalid. Unless one of these actions is taken, the OSHA attorney will file a motion to hold the businessman in contempt of court as soon as the inspector with the warrant is denied entrance to the premises. Thus the stakes are high for any businessman who refuses admission to an inspector with a warrant. Businessmen must develop a strategy for dealing with OSHA and other federal inspectors whose actions may be subject to the requirements of the Barlow's decision. This strategy must be thorough and complete, must be developed in consultation with experienced counsel, and must be thoroughly explained to all management personnel who may be faced with the request for an inspection. To develop such a strategy, the businessman must take the following steps:
American Pharmacy VoI.NS19, No.2, Feb.1979/84
t
! {
{ ~ t
\
• Gain a thorough understanding from counsel of legal rights and options; • Calculate the anticipated costs oflegal action to contest the inspector's right to conduct an inspection of the premises, including disruption of business, legal fees, and expenses; • Compose an outline of how to act if confronted by an inspector, how to assert the right to demand a warrant, how to question the inspector with a warrant about the basis for the warrant, how to determine the scope and timeliness of any complaints leading to the inspection, how to preserve the employer's rights while permitting an inspection if the inspector is hostile or otherwise adamant about entering the premises, and finally, how to maximize the exercise of legal rights while still complying with the law.
'Whether FDA can invoke penalties for refusal to permit inspection without first obtaining a warrant is unresolved .... I
(
f
Obviously, some additional considerations may arise depending on the specific business establishment. The strategy must be oriented to particular circumstances and needs, such as whether there are trade secrets to protect, whether any portion of the premises is customarily open to the public, whether the premises contain inherently hazardous equipment or substances, and whether the business has a "good" or "bad" previous inspection experience with the local OSHA office. Thus community pharmacists, drug wholesalers, and manufacturers may have different reasons for per-
American Pharmacy VoI.NS19, No.2, Feb.1979/85
mitting or refusing an inspection. Nevertheless, all these questions must be considered in weighing the advantages and disadvantages of demanding or contesting a warrant. Impact on Other Agencies The Barlow's case reaffirmed the general prohibition of warrantless searches of private property. Two exceptions to that rule concern "pervasively regulated" businesses 6 and closely regulated industries long subject to close supervision and inspection. 7 In other words, industries already subject to close governmental scrutiny are not afforded the same rights to demand a search warrant as are other establishments. The two most commonly noted examples are businesses dealing in liquor and firearms. In the Barlow's decision the Supreme Court resisted broadening the rule that warrantless searches were the exception; however, it was also made clear that the Barlow's decision applied solely to OSHA. Thus the question of which businesses (other than liquor and firearms) are pervasively regulated, and therefore able to be inspected without a warrant, was left open. Of particular interest to the pharmacy profession and pharmaceutical industry is whether inspectors from the Food and Drug Administration (FDA) are required to obtain search warrants if permission to inspect business premises is denied. Under the law, FDA inspectors "are authorized ... to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held ... and ... to inspect" such premises. 8 The consequences for refusal to allow entry are a $1,000 fine, one year's imprisonment, or both. 9 The FDA has taken the position that pharmacies or other establishments subject to FDA inspection are pervasively regulated and that businessmen operating such premises do not have the right to demand a search warrant. However, as a practical matter, FDA inspectors who
were denied access to inspect in the past generally did obtain search warrants. In addition, the FDA's Inspection Operations Manual instructs FDA inspectors to obtain a Warrant for Inspection where permission to inspect is refused.1 o Several courts have upheld the FDA's right to inspect without obtaining a warrant, where consent to an inspection was obtained.1! Whether FDA can invoke the penalties described above for refusal to permit inspection without first obtaining a warrant is unresolved. 12,13 FDA has taken the position that it can.1 4 The pharmacist or wholesaler confronted by an unwanted FDA inspection has few clear options. If permission to inspect is refused and the FDA seeks criminal penalties, rather than or in addition to a warrant, the Supreme Court eventually may decide whether warrantless FDA inspections can be refused. This potential problem places pharmacists and others subject to FDA inspections in a precarious position, and careful legal planning is vital before the bold step of refusing admission to an FDA inspector is taken. While the Barlow's decision reaffirmed the rights of businessmen to be free from unreasonable searches and seizures, unresolved questions remain even with regard to OSHA inspections. In addition, the need for search warrants in administrative inspections such as those performed by the FDA is unclear. These open questions underscore the need for businessmen to be aware of their rights and to develop a plan of action, or inaction, before an inspector appears at the door. D References 1. Atlas Roofing Company, Inc" v. O.S.H.R.c' ef aI., _U.s.~
975.0.1261 (1977).
2. Barlow's, Inc" v. Usery, 424 F. Supp. 432 (D. Idaho 1976). 3. Marshall v. Barlow's, Inc., _U.S.~ 98 S.O. 1816 (1978).
4. Metal Bellows Corp,,--F.2d_(lstCir.Dkt.No.78-1038). 5. Occupational Safety & Health Reporter, 238, July 20, 1978. 6. United States v. Bi5weII, 406 U.S. 311 (1972). 7. Colonnade Catering Corp. v. United States, 397 U.S. 72 (1970). 8. 21 USC §374(a)(1970). 9. 21 USC §331(f); 333(a) (1970). 10. Inspection Operations Manual, §S.14.11(Nov. 10, 1977). 11. United Stafes v. Thriftimart, Inc., 429 F.2d 1006 (9th Cir. 1970). 12. United States v. Thriftimart,inc" 429 F.2d 1010 (9th Cir. 1970). 13. United Sfates v. Bi,weII, 406 U.S. 315 (1972). 14. Inspection Operations Manual, §SlS (Nov. 10, 1977).
29
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The Itnpact of the Barlow's Decision By LLOYD A. FOX and IRA J. SMOTHERMAN JR.
26
Lloyd A. Fox, a pharmacist-attorney, is a partner in the law firm of Stokes and Shapiro, 2300 National Bank Tower, Atlanta, GA 30303, and has published many articles in the area of pharmacy law. Ira J. Smotherman Jr. is also a partner in the law firm of Stokes and Shapiro. He practices law in the OSHA area and was cocounsel on the Atlas Roofing Supreme Court OSHA constitutional test case.
American Pharmacy VoI.NS19, No.2, Feb.1979/82
I p
~
( ('
in the nature of criminal penalties; and that the Act violated the Seventh Amendment right to a jury trial. None of these arguments swayed the United States Supreme Court, which affirmed the constitutionality of the Act. 1 Several other cases were winding their way through the lower federal courts at that time. These cases arose when businessmen refused to allow OSHA inspectors to inspect their business premises without a search warrant.
The Fourth Amendment and the Barlow's Decision The Right to Inspect. The Fourth Amendment protects citizens against unreasonable searches and seizures by the federal government. In order to conduct a search, police and other public authorities must persuade a judge or magistrate that there is "probable cause" that a law has been violated. In one of the OSHA cases, a small construction contractor in Idaho refused to allow an OSHA inspector on his business premises. OSHA demanded a court order allowing the inspection. The federal court instead ruled that the Act was unconstitutional because it did not require search warrants prior to inspections. 2 Other courts followed the same reasoning and required OSHA to obtain warrants if the employers objected to OSHA inspections. OSHA appealed the Idaho decision, and on May 23, 1978, in Marshall v. Barlow's, Inc., the Supreme Court declared that OSHA inspections conducted without search warrants violate the Fourth Amendment unless the owner of the business consents to the inspection. If the owner refuses consent, the Court ruled that the Fourth Amendment requires an OSHA inspector to obtain a search warrant based on probable cause. The Supreme Court adopted a vague but broad standard of probable cause. Specific evidence of an existing violation obviously satisfies the criteria, but the court specifically rejected the notion that the inspector must present evidence
-
American Pharmacy VoI.NS19. No.2. Feb.1979/83
of this kind. Probable cause could be shown by evidence that "reasonable legislative or administrative standards for conducting an ... inspection are satisfied with respect to a particular [establishment]." What standards are "reasonable" for issuing a search warrant is anyone's guess, but according to the Court, statements that OSHA has an inspection program designed to assure maximum compliance, and that a particular business is within the program's jurisdiction, are insufficient. Allegations must be supported by facts, and presumably the judicial officer must decide on the reasonableness of the specific standards or program. Of course, the judge's decision usually can (and will) be reached without consid-
'The warrant procedure raises problems for pharmacists who attempt to decide in advance how to react to an inspection request . ... '
eration of arguments from the employer contesting the inspection. The warrant procedure described by the Supreme Court raises problems for pharmacists and others who attempt to decide in advance how to react to an inspection request and whether to require a warrant. Depending on lower court interpretations, OSHA may have no trouble devising standards that will virtually guarantee a warrant for any inspection. A Massachusetts case is considering a challenge to OSHA's contention that selection of business for inspection under its "worst first" plan for increased inspection of hazardous industries satisfies the Supreme Court's "probable cause" test. 4 (Just prior to publication, this case was dismissed as being "moot" because OSHA surrendered the warrant.)
The Plain View Doctrine. While it is now clear that an OSHA inspector can be required to obtain a search warrant if denied permission to inspect, several other legal principles may interfere with the exercise of individual rights. If the business premises are not owned and occupied solely by the business to be inspected, OSHA may seek consent from someone else with ownership or possession of the premises, such as a landlord or tenant. If this other party gives consent, the consent will probably be valid; even if it is not, the businessman seeking to block the inspection will probably have to go to court immediately to seek a temporary restraining order to keep the inspector out-an expensive and time-consuming process. The OSHA inspector also has a right, under general Fourth Amendment principles, to inspect and investigate any conditions which appear to violate the Act and which are in "plain view" while he or she is standing in a public area such as the public portion of retail business premises. Community pharmacies and hospitals could be subject to application of the plain view doctrine, and pharmacists should be aware of its ramifications. Further, the plain view doctrine allows charges based on violations detected during such a search, even when such violations were not originally in plain view. The plain view doctrine also can be combined with the powers granted by a search warrant. The Supreme Court stated that the search permitted by a warrant would be subject, as in other cases, to the scope of the warrant. Thus if an inspector obtained a warrant to search the offices of an industrial business, the search would be limited to that specific area and could not be expanded to an adjacent warehouse or factory without consent. However, if the inspector, while in the offices, noticed a violation in an adjacent area, he or she could legally inspect and investigate this violation (even to the point of questioning other workers on any part of the premises) because the
27
violation wa's in plain view from an area in which the inspector had a right to be. The inspector could not use such a warrant as a springboard to inspect the entire premises, since the entire premises were not particularized in the warrant.
Reaction to the Barlow's Decision Although the Barlow's decision left a number of questions in its wake, the reaction of business, labor, and government followed predictable lines. In the decision, the Supreme Court stated that it expected the great majority of businessmen to consent to warrantless inspections. As can be expected, OSHA announced that it would continue its present policy of not obtaining warrants unless refused entry. The Environmen tal Protection Agency also stated its expectation that its inspectors would not generally be required to obtain warrants. At least initially, the expectations of the Supreme Court and the governmental agencies have been fulfilled. As of July 7, 1978, only 291, or 1.5 percent, of the 19,216 employers inspected since the Barlow's decision on May 23 had demanded search warrants. S While this continued vol.untary compliance must be warmly received by labor groups which decried the Supreme Court's decision, the anti-OSHA forces, which generally greeted the Barlow's decision favorably, have announced plans to inform employers of their right to demand warrants and to urge them to exercise these rights.
The Practical Side While the Barlow's ruling is an important reaffirmation of Fourth Amendment rights, particularly for business, a businessman must take several items into consideration before refusing admission to an OSHA inspector or another federal or state inspector. Clarification of the Supreme Court's decision is several years away. The businessman who is considering refusal of per-
28
mission to inspect will have to make very important decisions with the OSHA inspector on the doorstep, and without knowing how the ambiguities in the original decision will be resolved. The businessman must evaluate the benefits, risks, and alternatives and develop a strategy in keeping with the perceived best interests of the business. Since forthcoming court decisions may make it very easy for OSHA to obtain a search warrant for any inspection, the businessman is faced with the possibility of simply angering the OSHA inspector by asking for a warrant. Contesting the validity of the basis for the warrant may be unsuccessful and may anger the OSHA officials even more. The businessman may be considered uncoopera tive" and likely to be hiding something. While OSHA officials and legal counsel have stated categorically that inspectors will be courteous when denied permission to inspect, and will obtain warrants quickly, inspectors are subject to the same psychological pressures as other persons, and the possibility of a harsh reaction by an inspector must be considered in the businessman's determination of what course to follow. If a businessman deni~s permission for an inspection, the OSHA
If
officials will attempt, through their attorneys, to secure a warrant. This procedure is done ex parte, that is, without the presence of the businessman or attorney. The attorney for OSHA simply goes to the federal magistrate alone or with the OSHA inspector and requests the magistrate to issue a warrant. The application for the warrant is supported by an affidavit of the inspector or of another person who has knowledge of the complaint or other facts that OSI-IA will cite as justifying the warrant. Ordinarily, unless the businessman has put the magistrate on notice of a possible application by OSHA for a warrant and has specifically asked for a hearing, the magistrate will make an immediate decision either to issue or not to issue the warrant. If a warrant is issued, the businessman's recourse is to refuse to permit the inspection when the inspector arrives with the warrant. If this step is taken the businessman should immediately file a motion with either the federal magistrate or the federal court to quash (nullify) the warrant as invalid or should file suit to enjoin the inspection pursuant to the warrant, on the grounds that the warrant is invalid. Unless one of these actions is taken, the OSHA attorney will file a motion to hold the businessman in contempt of court as soon as the inspector with the warrant is denied entrance to the premises. Thus the stakes are high for any businessman who refuses admission to an inspector with a warrant. Businessmen must develop a strategy for dealing with OSHA and other federal inspectors whose actions may be subject to the requirements of the Barlow's decision. This strategy must be thorough and complete, must be developed in consultation with experienced counsel, and must be thoroughly explained to all management personnel who may be faced with the request for an inspection. To develop such a strategy, the businessman must take the following steps:
American Pharmacy VoI.NS19, No.2, Feb.1979/84
t
! {
{ ~ t
\
• Gain a thorough understanding from counsel of legal rights and options; • Calculate the anticipated costs oflegal action to contest the inspector's right to conduct an inspection of the premises, including disruption of business, legal fees, and expenses; • Compose an outline of how to act if confronted by an inspector, how to assert the right to demand a warrant, how to question the inspector with a warrant about the basis for the warrant, how to determine the scope and timeliness of any complaints leading to the inspection, how to preserve the employer's rights while permitting an inspection if the inspector is hostile or otherwise adamant about entering the premises, and finally, how to maximize the exercise of legal rights while still complying with the law.
'Whether FDA can invoke penalties for refusal to permit inspection without first obtaining a warrant is unresolved .... I
(
f
Obviously, some additional considerations may arise depending on the specific business establishment. The strategy must be oriented to particular circumstances and needs, such as whether there are trade secrets to protect, whether any portion of the premises is customarily open to the public, whether the premises contain inherently hazardous equipment or substances, and whether the business has a "good" or "bad" previous inspection experience with the local OSHA office. Thus community pharmacists, drug wholesalers, and manufacturers may have different reasons for per-
American Pharmacy VoI.NS19, No.2, Feb.1979/85
mitting or refusing an inspection. Nevertheless, all these questions must be considered in weighing the advantages and disadvantages of demanding or contesting a warrant. Impact on Other Agencies The Barlow's case reaffirmed the general prohibition of warrantless searches of private property. Two exceptions to that rule concern "pervasively regulated" businesses 6 and closely regulated industries long subject to close supervision and inspection. 7 In other words, industries already subject to close governmental scrutiny are not afforded the same rights to demand a search warrant as are other establishments. The two most commonly noted examples are businesses dealing in liquor and firearms. In the Barlow's decision the Supreme Court resisted broadening the rule that warrantless searches were the exception; however, it was also made clear that the Barlow's decision applied solely to OSHA. Thus the question of which businesses (other than liquor and firearms) are pervasively regulated, and therefore able to be inspected without a warrant, was left open. Of particular interest to the pharmacy profession and pharmaceutical industry is whether inspectors from the Food and Drug Administration (FDA) are required to obtain search warrants if permission to inspect business premises is denied. Under the law, FDA inspectors "are authorized ... to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held ... and ... to inspect" such premises. 8 The consequences for refusal to allow entry are a $1,000 fine, one year's imprisonment, or both. 9 The FDA has taken the position that pharmacies or other establishments subject to FDA inspection are pervasively regulated and that businessmen operating such premises do not have the right to demand a search warrant. However, as a practical matter, FDA inspectors who
were denied access to inspect in the past generally did obtain search warrants. In addition, the FDA's Inspection Operations Manual instructs FDA inspectors to obtain a Warrant for Inspection where permission to inspect is refused.1 o Several courts have upheld the FDA's right to inspect without obtaining a warrant, where consent to an inspection was obtained.1! Whether FDA can invoke the penalties described above for refusal to permit inspection without first obtaining a warrant is unresolved. 12,13 FDA has taken the position that it can.1 4 The pharmacist or wholesaler confronted by an unwanted FDA inspection has few clear options. If permission to inspect is refused and the FDA seeks criminal penalties, rather than or in addition to a warrant, the Supreme Court eventually may decide whether warrantless FDA inspections can be refused. This potential problem places pharmacists and others subject to FDA inspections in a precarious position, and careful legal planning is vital before the bold step of refusing admission to an FDA inspector is taken. While the Barlow's decision reaffirmed the rights of businessmen to be free from unreasonable searches and seizures, unresolved questions remain even with regard to OSHA inspections. In addition, the need for search warrants in administrative inspections such as those performed by the FDA is unclear. These open questions underscore the need for businessmen to be aware of their rights and to develop a plan of action, or inaction, before an inspector appears at the door. D References 1. Atlas Roofing Company, Inc" v. O.S.H.R.c' ef aI., _U.s.~
975.0.1261 (1977).
2. Barlow's, Inc" v. Usery, 424 F. Supp. 432 (D. Idaho 1976). 3. Marshall v. Barlow's, Inc., _U.S.~ 98 S.O. 1816 (1978).
4. Metal Bellows Corp,,--F.2d_(lstCir.Dkt.No.78-1038). 5. Occupational Safety & Health Reporter, 238, July 20, 1978. 6. United States v. Bi5weII, 406 U.S. 311 (1972). 7. Colonnade Catering Corp. v. United States, 397 U.S. 72 (1970). 8. 21 USC §374(a)(1970). 9. 21 USC §331(f); 333(a) (1970). 10. Inspection Operations Manual, §S.14.11(Nov. 10, 1977). 11. United Stafes v. Thriftimart, Inc., 429 F.2d 1006 (9th Cir. 1970). 12. United States v. Thriftimart,inc" 429 F.2d 1010 (9th Cir. 1970). 13. United Sfates v. Bi,weII, 406 U.S. 315 (1972). 14. Inspection Operations Manual, §SlS (Nov. 10, 1977).
29
~
